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SONN:Segment
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended December 31, 2024
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____ to _____
Commission
file number: 001-35570
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware |
|
20-2932652 |
(State
or Other Jurisdiction of |
|
(I.R.S.
Employer |
Incorporation
or Organization) |
|
Identification
No.) |
100
Overlook Center, Suite 102, Princeton, NJ |
|
08540 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
(609)
375-2227
(Registrant’s
Telephone Number, Including Area Code)
Not
applicable
(Former
Name, Former Address and Former Fiscal Year, if Changed Since Last Report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
|
SONN |
|
The
Nasdaq Capital Market LLC |
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒ Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
|
|
|
|
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
|
|
|
|
Emerging
growth company |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
☐
Yes ☒ No
There
were 3,065,701 shares of common stock, par value $0.0001 per share, of Sonnet BioTherapeutics Holdings, Inc. issued and outstanding as
of February 12, 2025.
Sonnet
BioTherapeutics Holdings, Inc. and Subsidiaries
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
INDEX
TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
PART
I - FINANCIAL INFORMATION
Item
1: Financial Statements.
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Balance Sheets
(unaudited)
| |
December
31, 2024 | | |
September
30, 2024 | |
Assets | |
| | | |
| | |
Current
assets: | |
| | | |
| | |
Cash | |
$ | 4,861,503 | | |
$ | 149,456 | |
Unbilled collaboration revenue | |
| 500,000 | | |
| — | |
Prepaid
expenses and other current assets | |
| 1,196,868 | | |
| 1,206,409 | |
Incentive
tax receivable | |
| 166,792 | | |
| 762,078 | |
Total
current assets | |
| 6,725,163 | | |
| 2,117,943 | |
Property
and equipment, net | |
| 17,312 | | |
| 20,523 | |
Operating
lease right-of-use asset | |
| 104,435 | | |
| 123,417 | |
Deferred
offering costs | |
| 122,058 | | |
| 15,000 | |
Other
assets | |
| 213,059 | | |
| 494,147 | |
Total
assets | |
$ | 7,182,027 | | |
$ | 2,771,030 | |
Liabilities
and stockholders’ equity (deficit) | |
| | | |
| | |
Current
liabilities: | |
| | | |
| | |
Accounts
payable | |
$ | 1,639,981 | | |
$ | 2,183,416 | |
Accrued
expenses and other current liabilities | |
| 1,394,520 | | |
| 942,489 | |
Current
portion of operating lease liability | |
| 87,323 | | |
| 84,291 | |
Total
current liabilities | |
| 3,121,824 | | |
| 3,210,196 | |
Operating
lease liability, net of current portion | |
| 23,634 | | |
| 46,573 | |
Total
liabilities | |
| 3,145,458 | | |
| 3,256,769 | |
Commitments
and contingencies (Note 4) | |
| - | | |
| - | |
Stockholders’
equity (deficit): | |
| | | |
| | |
Preferred
stock, $0.0001 par value: 5,000,000 shares authorized; no shares issued or outstanding | |
| — | | |
| — | |
Common
stock, $0.0001 par value: 125,000,000 shares authorized; 3,007,431 and 650,284 issued and outstanding at December 31, 2024 and September
30, 2024, respectively | |
| 300 | | |
| 65 | |
Additional
paid-in capital | |
| 124,877,960 | | |
| 117,195,181 | |
Accumulated
deficit | |
| (120,841,691 | ) | |
| (117,680,985 | ) |
Total
stockholders’ equity (deficit) | |
| 4,036,569 | | |
| (485,739 | ) |
Total
liabilities and stockholders’ equity (deficit) | |
$ | 7,182,027 | | |
$ | 2,771,030 | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Statements of Operations
(unaudited)
| |
2024 | | |
2023 | |
| |
Three
Months Ended December 31, | |
| |
2024 | | |
2023 | |
Collaboration
revenue | |
$ | 1,000,000 | | |
$ | 18,626 | |
Operating
expenses: | |
| | | |
| | |
Research
and development | |
| 1,886,076 | | |
| 644,042 | |
General
and administrative | |
| 1,963,346 | | |
| 653,455 | |
Total
operating expenses | |
| 3,849,422 | | |
| 1,297,497 | |
Loss
from operations | |
| (2,849,422 | ) | |
| (1,278,871 | ) |
Foreign
exchange (loss) gain | |
| (152,884 | ) | |
| 110,362 | |
Provision for income taxes | |
| (158,400 | ) | |
| — | |
Net
loss | |
$ | (3,160,706 | ) | |
$ | (1,168,509 | ) |
| |
| | | |
| | |
Per
share information: | |
| | | |
| | |
Net
loss per share, basic and diluted | |
$ | (1.56 | ) | |
$ | (2.46 | ) |
Weighted
average shares outstanding, basic and diluted | |
| 2,022,818 | | |
| 474,699 | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Statements of Changes in Stockholders’ Equity (Deficit)
(unaudited)
| |
Shares | | |
Amount | | |
capital | | |
deficit | | |
Total | |
| |
Common
stock | | |
Additional
paid-in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
capital | | |
deficit | | |
Total | |
Balance
at October 1, 2024 | |
| 650,284 | | |
$ | 65 | | |
$ | 117,195,181 | | |
$ | (117,680,985 | ) | |
$ | (485,739 | ) |
Sale
of common stock, net of issuance costs | |
| 1,050,500 | | |
| 105 | | |
| 7,622,514 | | |
| — | | |
| 7,622,619 | |
Retirement
of shares in connection with reverse stock split | |
| (373 | ) | |
| — | | |
| — | | |
| — | | |
| — | |
Shares released from abeyance | |
| 32,375 | | |
| 3 | | |
| (3 | ) | |
| — | | |
| — | |
Net
share settlement of warrants | |
| 1,209 | | |
| — | | |
| — | | |
| — | | |
| — | |
Exercise of warrants | |
| 1,273,436 | | |
| 127 | | |
| (127 | ) | |
| — | | |
| — | |
Share-based
compensation | |
| — | | |
| — | | |
| 60,395 | | |
| — | | |
| 60,395 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (3,160,706 | ) | |
| (3,160,706 | ) |
Balance
at December 31, 2024 | |
| 3,007,431 | | |
$ | 300 | | |
$ | 124,877,960 | | |
$ | (120,841,691 | ) | |
$ | 4,036,569 | |
| |
Common
stock | | |
Additional
paid-in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
capital | | |
deficit | | |
Total | |
Balance
at October 1, 2023 | |
| 218,786 | | |
$ | 22 | | |
$ | 110,017,751 | | |
$ | (110,243,753 | ) | |
$ | (225,980 | ) |
Balance | |
| 218,786 | | |
$ | 22 | | |
$ | 110,017,751 | | |
$ | (110,243,753 | ) | |
$ | (225,980 | ) |
Sale
of common stock, net of issuance costs | |
| 163,281 | | |
| 16 | | |
| 3,916,927 | | |
| — | | |
| 3,916,943 | |
Retirement
of shares in connection with reverse stock split | |
| (190 | ) | |
| — | | |
| — | | |
| — | | |
| — | |
Net
share settlement of warrants | |
| 1,795 | | |
| — | | |
| — | | |
| — | | |
| — | |
Share-based
compensation | |
| — | | |
| — | | |
| 50,005 | | |
| — | | |
| 50,005 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (1,168,509 | ) | |
| (1,168,509 | ) |
Balance
at December 31, 2023 | |
| 383,672 | | |
$ | 38 | | |
$ | 113,984,683 | | |
$ | (111,412,262 | ) | |
$ | 2,572,459 | |
Balance | |
| 383,672 | | |
$ | 38 | | |
$ | 113,984,683 | | |
$ | (111,412,262 | ) | |
$ | 2,572,459 | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Statements of Cash Flows
(unaudited)
| |
2024 | | |
2023 | |
| |
Three
Months Ended December 31, | |
| |
2024 | | |
2023 | |
Cash
flows from operating activities: | |
| | | |
| | |
Net
loss | |
$ | (3,160,706 | ) | |
$ | (1,168,509 | ) |
Adjustments
to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 3,211 | | |
| 3,211 | |
Acquired
in-process research and development | |
| 12,000 | | |
| 12,000 | |
Amortization
of operating lease right-of-use asset | |
| 18,982 | | |
| 16,763 | |
Share-based
compensation | |
| 60,395 | | |
| 50,005 | |
Changes
in operating assets and liabilities: | |
| | | |
| | |
Unbilled collaboration revenue | |
| (500,000 | ) | |
| — | |
Prepaid
expenses and other current assets | |
| 9,541 | | |
| 269,116 | |
Incentive
tax receivable | |
| 595,286 | | |
| 592,463 | |
Other
assets | |
| 281,088 | | |
| (77,656 | ) |
Accounts
payable | |
| (635,568 | ) | |
| (465,735 | ) |
Accrued
expenses and other current liabilities | |
| 425,432 | | |
| (2,287,544 | ) |
Operating
lease liability | |
| (19,907 | ) | |
| (17,225 | ) |
Deferred
income | |
| — | | |
| (18,626 | ) |
Net
cash used in operating activities | |
| (2,910,246 | ) | |
| (3,091,737 | ) |
Cash
flows from financing activities: | |
| | | |
| | |
Proceeds
from issuance of common stock, net of issuance costs | |
| 7,711,161 | | |
| 3,838,870 | |
Payment
of deferred offering costs | |
| (75,000 | ) | |
| — | |
Payment of warrant issuance costs | |
| (13,868 | ) | |
| — | |
Net
cash provided by financing activities | |
| 7,622,293 | | |
| 3,838,870 | |
| |
| | | |
| | |
Net
increase in cash | |
| 4,712,047 | | |
| 747,133 | |
Cash,
beginning of period | |
| 149,456 | | |
| 2,274,259 | |
Cash,
end of period | |
$ | 4,861,503 | | |
$ | 3,021,392 | |
| |
| | | |
| | |
Supplemental
disclosure of non-cash operating, investing and financing activities: | |
| | | |
| | |
In-process
research and development in accrued expenses | |
$ | 12,000 | | |
$ | 12,000 | |
Deferred
offering costs in accounts payable and accrued expenses | |
$ | 32,058 | | |
$ | 15,000 | |
Common stock issuance costs in accounts payable | |
$ | 88,542 | | |
$ | — | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
1.
Organization and Description of Business
Description
of business
Sonnet
BioTherapeutics, Inc. (“Prior Sonnet”) was incorporated as a New Jersey corporation on April 6, 2015. Prior Sonnet completed
a merger with publicly-held Chanticleer Holdings, Inc. (“Chanticleer”) on April 1, 2020. After the merger, Chanticleer changed
its name to Sonnet BioTherapeutics Holdings, Inc. (“Sonnet” or the “Company”). Sonnet is a clinical stage, oncology-focused
biotechnology company with a proprietary platform for innovating biologic medicines of single or bifunctional action. Known as FHAB™
(Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and “hitch-hikes”
on human serum albumin (“HSA”) for transport to target tissues. Sonnet designed the construct to improve drug accumulation
in solid tumors, as well as to extend the duration of activity in the body. FHAB development candidates can be produced in
mammalian cell culture, which enables glycosylation of the interleukins, thereby reducing the risk of immunogenicity, as well as E. coli.
Sonnet believes its FHAB technology, for which it received a U.S. patent in June 2021, is a distinguishing feature of its
biopharmaceutical platform. The approach is well suited for future drug development across a range of human disease areas, including
in oncology, autoimmune, pathogenic, inflammatory, and hematological conditions.
Sonnet’s
lead proprietary asset, SON-1010, is a fully human version of Interleukin 12 (“IL-12”), covalently linked to the FHAB
construct, for which Sonnet is pursuing clinical development in solid tumor indications, including ovarian cancer, non-small cell lung
cancer and head and neck cancer. In March 2022, the FDA cleared Sonnet’s Investigational New Drug (“IND”) application
for SON-1010. This allowed the Company to initiate a U.S. clinical trial (SB101) in oncology patients with solid tumors during the second
calendar quarter of 2022. In September 2021, the Company created a wholly-owned Australian subsidiary, SonnetBio Pty Ltd (“Subsidiary”),
for the purpose of conducting certain clinical trials. Sonnet received approval and initiated an Australian clinical study (SB102) of
SON-1010 in healthy volunteers during the third calendar quarter of 2022. Interim safety and tolerability data from the SB101 and SB102
studies were reported in April 2023.
In
January 2023, Sonnet announced a collaboration agreement with Roche for the clinical evaluation of SON-1010 with atezolizumab (Tecentriq®).
The companies have entered into a Master Clinical Trial and Supply Agreement (“MCSA”), along with ancillary Quality and Safety
Agreements, to study the safety and efficacy of the combination of SON-1010 and atezolizumab in a platinum-resistant ovarian cancer (“PROC”)
patient setting. Further, the companies will provide SON-1010 and atezolizumab, respectively, for use in the Phase 1b/Phase 2a combination
safety, dose-escalation, and proof-of-concept study (SB221). Part 1 of this 2-part study was approved in June 2023 by the local Human
Research Ethics Committee in Australia under CT-2023-CTN-01399-1 and the Therapeutic Goods Administration has been notified. In August
2023, the FDA accepted the IND for SB221. The trial consists of a modified 3+3 dose-escalation design in Part 1 to establish the maximum
tolerated dose (“MTD”) of SON-1010 with a fixed dose of atezolizumab. Clinical benefit in PROC will be confirmed in an expansion
group to establish the recommended Phase 2 dose (“RP2D”). Part 2 of the study will then investigate SON-1010 in combination
with atezolizumab, or the standard of care (“SOC”) for PROC in a randomized comparison to show proof-of-concept (“POC”).
In
January 2025, Sonnet announced an expansion of its Phase 1 SB101 clinical study of SON-1010 to add a new cohort to evaluate its effect
in combination with trabectedin (Yondelis®), following the successful completion of monotherapy dose escalation. Trabectedin
is an alkylating DNA-binding agent that was approved as a second-line treatment in early 2024 for patients with unresectable, metastatic
liposarcoma or leiomyosarcoma who have received a prior anthracycline-containing regimen. It is also known to activate tumor macrophages
into a pro-inflammatory phenotype. The Company believes that SON-1010 has the potential to complement that activity by activating the
NK and T cells in the TME to secrete more interferon-gamma (IFNγ), which is considered to be important for anti-tumor control.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
Company acquired the global development rights to its most advanced compound, SON-080, a fully human version of Interleukin 6 (“IL-6”),
in April 2020 through its acquisition of the outstanding shares of Relief Therapeutics SA. Sonnet is advancing SON-080 in target indications
of Chemotherapy-Induced Peripheral Neuropathy (“CIPN”) and Diabetic Peripheral Neuropathy (“DPN”). Sonnet received
approval to initiate an ex-U.S. Phase 1b/2a study with SON-080 in CIPN during the third quarter of 2022. The Data Safety Monitoring Board
(“DSMB”) overseeing the study met during the first calendar quarter of 2024 and cleared the trial to proceed to Part 2. Following
the completion of the DSMB review, Sonnet announced initial safety data from the CIPN study. The objective will be to analyze the data
and to consider initiating a Phase 2 study, pending the outcome of any partnering activity. On October 8, 2024, the Company entered into
a License Agreement (the “Alkem Agreement”) with Alkem Laboratories Limited (“Alkem”) to develop and commercialize
SON-080 for DPN in India. Alkem will conduct all clinical trials that it believes appropriate to obtain regulatory approval in India
for SON-080 for the treatment of DPN.
SON-1210
(IL12-FHAB-IL15), Sonnet’s lead bifunctional construct, combines FHAB with single-chain human IL-12 and
human Interleukin 15 (“IL-15”). This compound is being developed for solid tumor indications, including colorectal and
pancreatic cancer. In February 2023, Sonnet announced the successful completion of two IND-enabling toxicology studies with SON-1210
in non-human primates. In August 2024, the Company entered into a Master Clinical Collaboration Agreement (the “SOC
Agreement”) with the Sarcoma Oncology Center (“SOC”) to advance the development of SON-1210. An Innovative Immuno
Oncology Consortium (“IIOC”) that is funded by the SOC will conduct an investigator-initiated Phase 1b/2a study of
SON-1210 in pancreatic cancer. The IIOC submitted a pre-IND package to the FDA. Based on the FDA feedback, preparations for the full
IND submission package are underway.
SON-1411
(IL18-FHAB-IL12) is a bifunctional combination of human Interleukin 18 (“IL-18”), which was modified to resist
interaction with the IL-18 inhibitor binding protein, and single-chain human IL-12 for solid tumor cancers. Cell line development and
process development are ongoing, with early experimental drug supply suitable for formulation and analytical method development activities.
After some delays in 2024, activities will continue through 2025 with the potential to generate a drug suitable for preclinical studies
and subsequent human studies.
Sonnet
has completed sequence confirmation for SON-3015 (anti-IL6-FHAB-anti-TGFβ). Early-stage bifunctional drug has been generated
and is being stored for future use in in vivo mice studies. The Company has elected to place the SON-3015 development program on hold
for expense reduction purposes.
Liquidity
The Company has incurred recurring losses and
negative cash flows from operations since inception and it expects to generate losses from operations for the foreseeable future primarily
due to research and development costs for its potential product candidates. The Company believes its cash at December 31, 2024 of
$4.9 million will fund the Company’s projected operations into July 2025. The Company received preliminary approval of its application to sell up to $0.8 million of its New Jersey state
net operating losses through the Technology Business Tax Certificate Transfer Program (the “Program”), subject to execution
of such sale (see Note 8). Substantial additional financing will be needed by the
Company to fund its operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
The accompanying unaudited interim consolidated financial statements have been prepared on a going concern basis, which contemplates the
realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s
ability to continue as a going concern exists. The unaudited interim consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
The Company plans to secure additional capital
in the future through equity or debt financings, including sales pursuant to its ChEF Purchase Agreement (the “Purchase Agreement”)
with Chardan Capital Markets, LLC (“Chardan”), related to a “ChEF,” Chardan’s committed equity facility
(the “Facility”); partnerships; collaborations; or other sources to carry out the Company’s planned development activities.
If additional capital is not available when required, the Company may need to delay or curtail its operations until such funding is received.
Various internal and external factors will affect whether and when the Company’s product candidates become approved for marketing
and successful commercialization. The regulatory approval and market acceptance of the Company’s product candidates, length of time
and cost of developing and commercializing these product candidates and/or failure of them at any stage of the approval process will materially
affect the Company’s financial condition and future operations.
Operations
since inception have consisted primarily of organizing the Company, securing financing, developing technologies through research and
development and conducting preclinical studies. The Company faces risks associated with companies whose products are in development.
These risks include the need for additional financing to complete its research and development, achieving its research and development
objectives, defending its intellectual property rights, recruiting and retaining skilled personnel, and dependence on key members of
management.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
2.
Summary of Significant Accounting Policies
a. Basis of presentation
The
accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information as found in the Accounting Standards Codification (“ASC”)
and Accounting Standards Updates (ASUs”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management,
the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily
of accruals, estimates and assumptions that impact the unaudited interim consolidated financial statements) considered necessary to present
fairly the Company’s financial position as of December 31, 2024 and its results of operations and cash flows for the three
months ended December 31, 2024 and 2023. The unaudited interim consolidated financial statements presented herein do not contain
all of the required disclosures under U.S. GAAP for annual financial statements and should be read in conjunction with the annual audited
consolidated financial statements and related notes of Sonnet as of and for the year ended September 30, 2024 included in the Company’s
Annual Report on Form 10-K for the fiscal year ended September 30, 2024. The results of operations for the interim periods are not
necessarily indicative of the results of operations to be expected for the full year.
b. Consolidation
The
unaudited interim consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany
accounts and transactions have been eliminated in consolidation.
c. Use of estimates
The
preparation of the unaudited interim consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Significant estimates
and assumptions reflected in these unaudited interim consolidated financial statements include the accrual of research and development
expenses. Estimates and assumptions are periodically reviewed in-light of changes in circumstances, facts and experience. Changes in
estimates are recorded in the period in which they become known. Actual results could differ from management’s estimates.
d. Incentive tax receivable
Subsidiary
is eligible to participate in an Australian research and development tax incentive program. As part of this program, Subsidiary is eligible
to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by Subsidiary
in Australia. The
cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian) during the reimbursable
period. The Company estimates the amount of cash
refund it expects to receive related to the Australian research and development tax incentive program and records the incentive when
it is probable (i) the Company will comply with relevant conditions of the program and (ii) the incentive will be received. As of December 31,
2024, the Company’s estimate of the amount of cash refund it expects to receive for eligible spending related to the Australian
research and development tax incentive program was $0.2
million. For each of the three months ended December 31,
2024 and 2023, $0.2 million for the expected net cash refund related to the tax incentive program was included as a reduction in research
and development expenses. In November 2024, the Company received $0.7
million from the Australian government related
to eligible research and development expenses for the year ended September 30, 2024. In December 2023, the Company received $0.8 million from the Australian government related to eligible research and
development expenses for the year ended September 30, 2023.
e. Property and equipment
Property
and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Expenditures
for repairs and maintenance that do not extend the estimated useful life or improve an asset are expensed as incurred. Upon retirement
or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts, and any
resulting gain or loss is included in the consolidated statement of operations.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
f. Deferred offering costs
Legal
and other costs incurred in relation to equity offerings are capitalized as deferred offering costs and charged against the proceeds
from equity offerings when received. If a financing is abandoned, deferred offering costs are expensed.
g. Derivative liability
The
Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separate
accounting from the underlying agreement. An embedded derivative that requires separation is accounted for as a separate asset or liability
from the host agreement. The derivative asset or liability is accounted for at fair value, with changes in fair value recognized in the
consolidated statement of operations. The Company determined that certain features under the Purchase Agreement (see Note 6) qualified
as embedded derivatives. The derivative liability is accounted for separately from the Purchase Agreement at fair value, which
has been deemed de minimis.
h. Collaboration revenue
Collaboration
arrangements may contain multiple components, which may include (i) licenses; (ii) research and development activities; and (iii) the
manufacturing and supply of certain materials. Payments pursuant to these arrangements may include non-refundable payments, upfront payments,
milestone payments upon the achievement of significant regulatory and development events, sales milestones and royalties on product sales.
The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in
a future period.
In
determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under a collaboration arrangement,
the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of
whether the promised goods or services are performance obligations, including whether they are capable of being distinct; (iii) measurement
of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance
obligations; and (v) recognition of revenue as the Company satisfies each performance obligation.
The
Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations,
allocating transaction price to performance obligations within a contract, determining when performance obligations have been met,
and assessing the recognition of variable consideration. When consideration is received prior to the Company completing its
performance obligation under the terms of a contract, a contract liability is recorded as deferred income. Deferred income expected
to be recognized as revenue within the twelve months following the balance sheet date is classified as a current liability. In May
2021, the Company entered into a License Agreement (the “New Life Agreement”) with New Life Therapeutics Pte, Ltd.
(“New Life”). In October 2024, the Company entered into the Alkem Agreement. See Note 5 for further discussion of these agreements.
i. Research and development expense
Research
and development expenses include all direct and indirect costs associated with the development of the Company’s biopharmaceutical
products. These expenses include personnel costs, consulting fees, and payments to third parties for research, development, and manufacturing
services. These costs are charged to expense as incurred.
At
the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward
completion of the related project, based on the measure of progress as defined in the contract. Factors the Company considers in preparing
the estimates include costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of its service
providers. Such estimates are subject to change as additional information becomes available. Depending on the timing of payment to the
service providers and the progress that the Company estimates has been made as a result of the service provided, the Company will record
a prepaid expense or accrued liability relating to these costs. Upfront milestone payments made to third parties who perform research
and development services on the Company’s behalf are expensed as services are rendered. Contingent development or regulatory milestone
payments are recognized upon the related resolution of such contingencies.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
j. Foreign currency
Transaction gains and losses resulting from exchange rate changes on transactions
denominated in currencies other than the U.S. dollar are included in operations in the period in which the transaction occurs and reported
within the foreign exchange gain (loss) line item in the consolidated statement of operations.
k. Reverse stock split
On
September 30, 2024, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary
of State of the State of Delaware, which effected a 1-for-8 reverse stock split of the Company’s issued and outstanding shares
of common stock. As a result of the reverse stock split, every eight shares of common stock issued and outstanding
was converted into one share of common stock. The reverse stock split affected all stockholders uniformly and did not alter any stockholder’s
percentage interest in the Company’s equity. No fractional shares were issued in connection with the reverse stock split. Stockholders
who would otherwise be entitled to a fractional share of common stock were instead entitled to receive a proportional cash payment. The
reverse stock split did not change the par value or authorized number of shares of common stock. All common share and per share amounts
presented in the unaudited interim consolidated financial statements and accompanying notes have been retroactively adjusted to reflect
the reverse stock split.
l. Net loss per share
Basic
net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding
during each period (and potential shares of common stock that are exercisable for little or no consideration). Included in basic weighted-average
number of shares of common stock outstanding during the three months ended December 31, 2024 are pre-funded October 2023 warrants to
purchase 99,687 shares of common stock with an exercise price of $0.0008 per share, warrants exercised through the June 2024 inducement
offer for 155,125 shares of common stock that are being held in abeyance as of December 31, 2024 due to beneficial ownership limitations,
and pre-funded December 2024 warrants to purchase 545,500 shares of common stock with an exercise price of $0.0001 per share. Included
in basic weighted-average number of shares of common stock outstanding during the three months ended December 31, 2023 are pre-funded
October 2023 warrants to purchase 192,187 shares of common stock with an exercise price of $0.0008 per share.
Diluted
loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and
stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average
number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities
are not included in the calculation as the impact is anti-dilutive.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule of Potentially Dilutive Securities Excluded from Computation of Diluted Shares
| |
2024 | | |
2023 | |
| |
December
31, | |
| |
2024 | | |
2023 | |
Common
stock warrants August 2021 | |
| 14,031 | | |
| 14,031 | |
Underwriter
warrants August 2021 | |
| 284 | | |
| 284 | |
Chanticleer
warrants | |
| 6 | | |
| 6 | |
Series
C warrants | |
| 2,297 | | |
| 2,297 | |
Series
3 warrants | |
| 1,566 | | |
| 1,566 | |
Unvested
restricted stock units and awards | |
| 17,152 | | |
| 976 | |
Common
stock warrants February 2023 | |
| 31,563 | | |
| 33,982 | |
Underwriter
warrants February 2023 | |
| 1,933 | | |
| 1,933 | |
Common
stock private placement warrants June 2023 | |
| 28,409 | | |
| 28,409 | |
Placement
agent warrants June 2023 | |
| 852 | | |
| 852 | |
Common
stock warrants October 2023 | |
| 354,994 | | |
| 710,931 | |
Underwriter
warrants October 2023 | |
| 10,664 | | |
| 10,664 | |
Placement
agent warrants June 2024 | |
| 14,142 | | |
| — | |
Common
stock warrants June 2024 | |
| 703,125 | | |
| — | |
Common
stock warrants November 2024 | |
| 2,222,222 | | |
| — | |
Common
stock registered direct warrants December 2024 | |
| 1,085,325 | | |
| — | |
Common
stock PIPE warrants December 2024 | |
| 673,000 | | |
| — | |
Total
anti-dilutive weighted average shares | |
| 5,161,565 | | |
| 805,931 | |
m. Recent accounting pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU
2023-07, which is applicable to entities with a single reportable segment, will primarily require enhanced disclosures about significant
segment expenses and enhanced disclosures in interim periods. The guidance in ASU 2023-07 will be applied retrospectively and is effective
for annual reporting periods in fiscal years beginning after December 15, 2023 and interim reporting periods in fiscal years beginning
after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-07
will have on its consolidated financial statements and disclosures.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 is intended
to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the
rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the
income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning
after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated
financial statements and disclosures.
In
November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures
(Subtopic 220-40): Disaggregation of Income Statement Expenses, as subsequently amended by ASU 2025-01 to clarify the effective date,
which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation,
depreciation and amortization) included in certain expense captions presented in the consolidated statement of operations. The guidance
in this ASU is effective for annual reporting periods in fiscal years beginning after December 15, 2026, and interim periods in fiscal
years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial
statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the consolidated
financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its consolidated financial
statements and disclosures.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
3.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following:
Schedule
of Accrued Expenses and Other Current Liabilities
| |
December
31, 2024 | | |
September
30, 2024 | |
Compensation
and benefits | |
$ | 155,514 | | |
$ | 149,802 | |
Research
and development | |
| 969,684 | | |
| 617,545 | |
Professional
fees | |
| 267,587 | | |
| 173,319 | |
Other | |
| 1,735 | | |
| 1,823 | |
Accrued
expenses and other current liabilities | |
$ | 1,394,520 | | |
$ | 942,489 | |
4.
Commitments and Contingencies
Legal
proceedings
From
time to time, the Company is a party to various lawsuits, claims, and other legal proceedings that arise in the ordinary course of its
business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters
will have a material adverse effect on the Company’s consolidated financial position, results of operations, or cash flows.
License
agreements
In
July 2012, the Company entered into a Discovery Collaboration Agreement (the “Collaboration Agreement”) with XOMA (US) LLC
(“XOMA”), pursuant to which XOMA granted to the Company a non-exclusive, non-transferable license and/or right to use certain
materials, technologies and related information related to discovery, optimization and development of antibodies and related proteins
and to develop and commercialize products thereunder. The Company is obligated to make contingent milestone payments to XOMA totaling
$3.8 million on a product-by-product basis upon the achievement of certain development and approval milestones related to a product.
The Company has also agreed to pay XOMA low single-digit royalties on net sales of products sold by the Company. Royalties on each product
are payable on a country-by-country basis until the later of (i) a specified period of time after the first commercial sale, and (ii)
the date of expiration of the last valid claim in the last-to-expire of the issued patents covered by the Collaboration Agreement. The
first milestone was achieved in April 2022, at which time the Company incurred a $0.5 million license fee which was recorded as acquired
in-process research and development. No license fees were incurred during the three months ended December 31, 2024 and 2023.
In August 2015, the Company entered into a License
Agreement (the “ARES License Agreement”) with Ares Trading (“ARES”), a wholly-owned subsidiary of Merck KGaA.
Under the terms of the ARES License Agreement, as subsequently amended in October 2021, ARES has granted the Company a sublicensable,
exclusive, worldwide, royalty-bearing license on proprietary patents to research, develop, use and commercialize products using atexakin
alfa (“Atexakin”), a low dose formulation of human IL-6 in peripheral neuropathies and vascular complications. Pursuant to
the ARES License Agreement, the Company will pay ARES high single-digit royalties on net sales of products sold by the Company. Royalties
are payable on a product-by-product and country-by-country basis until the later of (i) a specified period of time after the first commercial
sale in such country, and (ii) the last date on which such product is covered by a valid claim in such country. Additionally, the Company
will pay ARES a percentage of all revenue received through sublicensing the IL-6 compound, including revenue from any upfront, milestone,
royalty, maintenance and similar payments, net of certain full time equivalent (“FTE”) costs incurred by the Company pursuant
to such sublicense. The percentage rate owed to ARES on sublicense revenue decreases depending on the point in time of execution of the
relevant sublicense agreement and the development progress accomplished by the Company to that point in time. The upfront cash payments
received by the Company pursuant to the New Life Agreement (see Note 5) were specifically excluded from the scope of the amended ARES
License Agreement. The Company owes ARES $0.1 million in license fees related to sublicense revenue received pursuant to the Alkem Agreement
(see Note 5), which is included in research and development expenses in the unaudited interim consolidated statement of operations for
the three months ended December 31, 2024. No license fees were incurred during the three months ended December 31, 2023.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In
January 2019, the Company entered into a Frame Services and License Agreement (the “Cellca Agreement”) with Sartorius Stedim
Cellca GMBH (“Cellca”), pursuant to which Cellca has granted the Company a worldwide, non-exclusive, perpetual, non-transferable
license to develop, manufacture or have manufactured, use, sell, import, export and/or otherwise commercialize product based on Cellca’s
work to generate a specified transfected cell line and develop an upstream production process for such cell line. The Cellca Agreement
is effective unless terminated by either party by giving six months notice, or by giving 14 days notice if terminated for good cause.
The Company is obligated to make milestone payments to Cellca totaling up to $0.7 million upon the achievement of certain development
and approval milestones if the Buy-Out Option is not exercised. The Company has a Buy-Out Option that will be effective between the time
of completion of a clinical trial and the receipt of regulatory approval for commercialization of product. The cost to exercise the Buy-Out
Option increases on each anniversary of the commencement date of the Buy-Out Option Period, and ranges from $0.1 million to $0.6 million.
The cost to exercise the Buy-Out Option will replace the $0.6 million contingent milestone payment due upon final regulatory approval.
The first milestone was achieved in April 2022, at which time the Company incurred a $0.1 million license fee which was recorded as acquired
in-process research and development. No license fees were incurred during the three months ended December 31, 2024 and 2023.
In
October 2021, the Company entered into a Non-Exclusive License Agreement (the “Brink Agreement”) with Brink Biologics Inc.
(“Brink”), pursuant to which Brink has granted the Company a non-exclusive, non-transferable license and limited right to
sublicense certain materials and related information to develop cell-based assays for batch, quality control, stability, efficacy, potency
or any other type of assay required for production and commercialization of products. During the product development phase, the Company
was obligated to make annual product development license fee payments of approximately $0.1
million. In April 2023, the Brink Agreement was
amended, effective November 2022, to reduce the annual license fee payments to $12,000
for storage. If materials are removed from storage
during the product development phase, the annual product development license fee of approximately $0.1
million will apply. If a product achieves commercial
status, the Company is obligated to make a commercial product license fee payment of approximately $0.1
million per commercial product. The amended agreement
has an initial term of one year and will automatically renew for one additional year unless terminated or converted to a product development
license. After the second year, the license will automatically convert to a full license requiring a product development or a commercial
product license fee unless the parties mutually agree to terminate the agreement. The Company incurred $12,000 in license fees during
the three months ended December 31, 2024 and 2023, which were recorded as acquired in-process research and development and included in
research and development expenses in the unaudited interim consolidated statements of operations.
In
February 2022, the Company entered into a Biological Materials License Agreement (the “InvivoGen Agreement”) with InvivoGen
SAS (“InvivoGen”), pursuant to which InvivoGen has granted the Company a worldwide, non-exclusive license to use certain
reporter cells for research, development and/or quality control purposes. The InvivoGen Agreement has an initial term of three years
and may be extended for two additional three-year periods upon written notice by the Company and payment of an approximately €0.1
million fee per extension (approximately $0.1 million as of December 31, 2024). No license fees were incurred during the three months ended
December 31, 2024 and 2023.
Collaboration agreement
In August 2024, the Company entered into a Master
Clinical Collaboration Agreement (the “SOC Agreement”) with the Sarcoma Oncology Center (“SOC”) to advance the
development of SON-1210. An Innovative Immuno Oncology Center funded by the SOC will conduct an investigator-initiated Phase 1/2a study
of SON-1210 in pancreatic cancer. The Company will provide the study drug and provide support services for the study. If the Company establishes
a partnership with a third party prior to the initiation of the initial efficacy combination trial under this collaboration, the Company
will incur, payable to the SOC, a one-time fee equal to the greater of 5% or $1.5 million from the first upfront payment received from
such third party partnership.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Research
and development agreement
In
December 2021, the Company entered into a Research and Development Agreement (the “Navigo Agreement”) with Navigo
Proteins GmbH (“Navigo”), pursuant to which Navigo will perform specified evaluation and development procedures to
evaluate certain materials to determine their commercial potential. Under the terms of the Navigo Agreement, the Company has granted
Navigo a royalty-free, non-exclusive, worldwide, non-sublicensable, non-transferable right and license to use certain technology to
perform the evaluation and development activities, and Navigo has granted the Company (i) an exclusive, worldwide, perpetual,
irrevocable, sublicensable, transferable, royalty-free right and license to research, develop, use, sell, have sold, distribute,
import or otherwise commercially exploit certain materials, and (ii) a non-exclusive, worldwide, perpetual, sublicensable,
non-transferable right and license to make or have made such materials. The Company incurred a $0.1 million
technology access fee upon execution of the Navigo Agreement, at which time it was recorded as acquired in-process research. The
Company is obligated to make contingent milestone payments to Navigo totaling up to $1.0 million
upon the achievement of certain evaluation and development milestones as outlined in the Navigo Agreement, of which $0.3
million of evaluation milestones have been previously recognized. No milestones
were achieved and no license
fees were incurred during the three months ended December 31, 2024 and 2023.
Employment
agreements
The
Company has entered into employment contracts with its officers and certain employees that provide for severance and continuation of
benefits in the event of termination of employment either by the Company without cause or by the employee for good reason, both as defined
in the contract. In addition, in the event of termination of employment following a change in control, as defined, either by the Company
without cause or by the employee for good reason, any unvested portion of the employee’s initial stock option grant becomes immediately
vested.
5.
Collaboration Revenue
New
Life Agreement
Under the New Life Agreement, the Company granted
New Life an exclusive license (with the right to sublicense) to develop and commercialize pharmaceutical preparations containing a specific
recombinant human IL-6, SON-080 (the “Compound”) (such preparations, the “Products”) for the prevention, treatment
or palliation of DPN in humans (the “DPN Field”) in Malaysia, Singapore, Indonesia, Thailand, Philippines, Vietnam, Brunei,
Myanmar, Lao PDR and Cambodia (the “Exclusive Territory”). New Life paid the Company an aggregate of $1.0 million in non-refundable
upfront cash payments in connection with the execution of the New Life Agreement. The related collaboration revenue was fully recognized
by December 31, 2023, as the Company had completed its performance obligations under the New Life Agreement. In December 2024, New Life
informed the Company that it has elected to move its business in a different direction and provided the Company with written notice of
its intention to exercise its Give Back Option, which is the right to give back the rights with respect to Products in the DPN Field in
one or more countries in the Exclusive Territory. The exercise of the Give Back Option is subject to the negotiation and mutual agreement
of terms between the Company and New Life.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Alkem
Agreement
Under the Alkem Agreement entered
into on October 8, 2024 (see Note 1), the Company
granted Alkem an exclusive license (with the right to sublicense) to research, develop, manufacture, import, export, market, use and
commercialize pharmaceutical products containing its IL-6 (SON-080) asset (or any derivatives, fragments or conjugates thereof) (the
“Compounds”) (such products, the “Products”) for the treatment of DPN (the “DPN Field”) and to
manufacture, import, export, market, use and commercialize Products for the treatment of CIPN and autonomic neuropathy (together
with the DPN Field, the “Fields”) in India. Except as provided for in the Alkem Agreement, the Company agreed not to
develop, use, sell, offer or otherwise commercialize any Compounds or Products for use in the DPN Field in India during the term of
the Alkem Agreement. The Company retains all rights to manufacture Compounds and Products anywhere in the world. The
Company and Alkem will enter into a follow-on supply agreement pursuant to which the Company will manufacture for Alkem Compounds
and Products for post-Phase 2 clinical development and commercialization in accordance with the Alkem Agreement on terms to be
negotiated by the parties. Pursuant to the terms of the Alkem Agreement, Alkem will bear the cost of, and be responsible for, among
other things, conducting clinical studies and additional non-clinical studies (if any, subject to both parties’ approval),
preparing and filing applications for regulatory approval and undertaking other developmental and regulatory activities for
commercializing Products in the DPN Field in India. Alkem will own and maintain all regulatory filings and approvals for Products in
India. Upon payment of a Clinical Data Access Fee (as defined in the Alkem Agreement), the Company will have rights to access and
use the data generated by the clinical trials conducted in connection with the Alkem Agreement. Under the terms of the Alkem
Agreement, Alkem will pay the Company $1.0
million in upfront payments and up to an additional $1.0
million in milestone payments. Additionally, the Company is entitled to receive a royalty equal to a percentage in the low double
digits of the net sales of the Product upon commercialization of SON-080 in India, less certain expenses as set forth in the Alkem
Agreement.
Revenue
recognition
The Company first assessed the Alkem Agreement
under ASC 808, Collaborative Arrangements (“ASC 808”), to determine whether the Alkem Agreement or units of accounts
within the Alkem Agreement represent a collaborative arrangement based on the risks and rewards and activities of the parties. The Company
applied relevant guidance from ASC 606, Revenue from Contracts with Customers (“ASC 606”), to evaluate the appropriate
accounting for the collaborative arrangement with Alkem.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In accordance with this guidance, the Company
identified the following obligations under the Alkem arrangement: (i) License to research, develop, market, import, use and commercialize
the Product in the DPN field in India (the “License”); and (ii) supply of Compound for a Phase 2 clinical trial (“Supply”).
The future supply agreement for post-Phase 2 clinical development represents an optional purchase, which will be accounted for as a separate
contract, and the Company did not identify any material right to be present. The Company determined that the License and Supply are not
distinct from each other and therefore combined these material promises into a single performance obligation. The Company determined the
initial transaction price of the single performance obligation to be $1.0 million, as the future development and commercialization milestones,
which represent variable consideration, are subject to constraint at inception. At the end of each subsequent reporting period, the Company
will reevaluate the probability of achievement of the future development and commercialization milestones subject to constraint and, if
necessary, will adjust its estimate of the overall transaction price. Any such adjustments will be recorded on a cumulative catch-up basis.
For the sales-based royalties, the Company will recognize revenue when the related sales occur.
Collaboration revenue from the single
performance obligation related to the Alkem Agreement was recognized at the point-in-time at which the Company transferred the License
and Supply to Alkem. Collaboration revenue from the single performance obligation related to the New Life Agreement was recognized over
the estimated performance of the research and development activities. The Company recognized $1.0 million and $18,626 of collaboration
revenue for the three months ended December 31, 2024 and 2023, respectively. As of December 31, 2024, the Company has recorded
a contract asset for $0.5 million related to the Alkem Agreement, which represents the unbilled amount related to the single performance
obligation and is included in unbilled collaboration revenue in the unaudited interim consolidated balance sheet.
6.
Stockholders’ Equity (Deficit)
October
2023 underwritten public offering
On
October 26, 2023, the Company closed a public offering of common stock and certain warrants through Chardan
and Ladenburg Thalmann & Co. Inc. as underwriters, for net proceeds of $3.9 million through the issuance and sale of 163,281 shares
of its common stock and, to certain investors, pre-funded warrants to purchase 192,187 shares of common stock, and accompanying common
warrants to purchase up to an aggregate of 710,931 shares of its common stock. Each share of common stock and pre-funded warrant to purchase
one share of common stock was sold together with a common warrant to purchase two shares of common stock. The public offering price of
each share of common stock and accompanying common warrant was $12.80 and the public offering price of each pre-funded warrant and accompanying
common warrant was $12.7992. The common warrants were immediately exercisable at a price of $12.80 per share of common stock, expire
five years from the date of issuance and contain an alternative cashless exercise provision. In connection with the June 2024 inducement
offer, the exercise price was decreased to $9.60 per share of common stock for common warrants that remained unexercised at the time
of the offer. The pre-funded warrants were immediately exercisable at any time, until exercised in full, at a price of $0.0008 per share
of common stock. In addition, warrants to purchase 10,664 shares of common stock were issued to the underwriters as compensation for
their services related to the offering. These common stock warrants have an exercise price of $16.00 per share and expire five years
from the date of issuance.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Committed
equity facility
On
May 2, 2024, the Company entered into the Purchase Agreement and a Registration Rights Agreement (the “Registration Rights
Agreement”), each with Chardan, related to a “ChEF,” Chardan’s committed equity facility, or the Facility
(see Note 1). Pursuant to the Purchase Agreement, the Company has the right from time to time at its option to sell to Chardan up to
$25.0
million in aggregate gross purchase price of newly issued shares of the Company’s common stock, of which $24.9
million is available to be sold as of December 31, 2024. The Facility will allow the Company to raise primary equity on a periodic
basis at its sole discretion depending on a variety of factors including, among other things, market conditions, the trading price
of the common stock, and determinations by the Company regarding the use of proceeds of such common stock. The purchase price of the
shares of common stock will be determined by reference to the Volume Weighted Average Price (“VWAP”) of the common stock
during the applicable purchase period, less a fixed 4%
discount to such VWAP, and the total shares to be purchased on any day may not exceed 20% of the trading volume of the
Company’s common stock during the applicable purchase period. The Purchase Agreement will be effective for a 36-month period
ending May 16, 2027. Due to certain pricing and settlement provisions, the Purchase Agreement qualifies as a standby equity purchase
agreement and includes an embedded put option and an embedded forward contract. The Company accounts for the embedded features in
the Purchase Agreement as derivatives measured at fair value, with changes in fair value recognized in the consolidated statement
of operations. The derivatives associated with the Purchase Agreement have been deemed de minimis. The Company did not
sell any shares of common stock pursuant to the Purchase Agreement during the three months ended December 31, 2024.
November
2024 underwritten public offering
On
November 7, 2024, the Company closed a public offering of common stock and certain warrants through Chardan, as underwriter, for net
proceeds of $4.2 million through the issuance and sale of 155,000 shares of its common stock, pre-funded warrants to purchase up to
956,111 shares of common stock, and accompanying common warrants to purchase up to an aggregate of 2,222,222 shares of its common stock.
Each share of common stock and pre-funded warrant to purchase one share of common stock was sold together with a common warrant to purchase
two shares of common stock. The public offering price of each share of common stock and accompanying common warrant was $4.50 and the
public offering price of each pre-funded warrant and accompanying common warrant was $4.4999. The common warrants were immediately exercisable
at a price of $4.50 per share of common stock, expire five years from the date of issuance and contain an alternative cashless exercise
provision. The pre-funded warrants were immediately exercisable at any time, until exercised in full, at a price of $0.0001 per share
of common stock. All of the pre-funded warrants have been exercised as of December 31, 2024.
December
2024 registered direct and PIPE offering
On
December 10, 2024, the Company closed a registered direct offering with institutional investors for the issuance and sale of 768,000
shares of its common stock, pre-funded warrants to purchase up to 317,325
shares of common stock, and accompanying warrants to purchase up to an aggregate of 1,085,325
shares of its common stock. Each share of common stock and pre-funded warrant to purchase one share of common stock was sold
together with a common warrant to purchase one share of common stock. The offering price of each share of common stock and
accompanying common warrant was $2.23 and the offering price of each pre-funded warrant and accompanying common warrant was $2.2299,
priced at-the-market under the rules of the Nasdaq Stock Market. The registered direct warrants were immediately exercisable at a
price of $2.10
per share, expire five
years from the date of issuance and contain an alternative cashless exercise provision. The pre-funded warrants were
immediately exercisable at any time, until exercised in full, at a price of $0.0001
per share of common stock. All of the pre-funded warrants have been exercised as of December 31, 2024.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
Company closed a concurrent private placement with an existing investor for the issuance and sale of 127,500
shares of its common stock, pre-funded warrants to purchase up to 545,500
shares of common stock, and accompanying warrants to purchase up to an aggregate 673,000
shares of its common stock. Each share of common stock and pre-funded warrant to purchase one share of common stock was sold in the
private placement (“PIPE”) together with a common warrant to purchase one share of common stock. The PIPE offering price
of each share of common stock and accompanying common warrant was $2.23 and the PIPE offering price of each pre-funded warrant and accompanying common warrant was $2.2299,
priced at-the-market under the rules of the Nasdaq Stock Market. The PIPE warrants were immediately exercisable at a price of $2.10
per share, expire five
years from the date of issuance and contain an alternative cashless exercise provision. The pre-funded warrants were
immediately exercisable at any time, until exercised in full, at a price of $0.0001
per share of common stock.
The
Company raised net proceeds of approximately $3.5 million from the registered direct and PIPE offering.
Common
stock warrants
As
of December 31, 2024, the following equity-classified warrants and related terms were outstanding:
Schedule
of Warrants Outstanding
| |
Warrants
Outstanding | | |
Exercise
Price | | |
Expiration
Date | |
Common
stock warrants August 2021 | |
| 14,031 | | |
$ | 2,094.4000 | | |
| August
24, 2026 | |
Underwriter
warrants August 2021 | |
| 284 | | |
$ | 2,618.0000 | | |
| August
19, 2026 | |
Chanticleer
warrants | |
| 6 | | |
| $144,144.0000
- $224,224.0000 | | |
| April
30, 2027 - December 17, 2028 | |
Series
C warrants | |
| 2,297 | | |
$ | 7,860.1600 | | |
| October
16, 2025 | |
Series
3 warrants | |
| 1,566 | | |
$ | 717.0240 | | |
| August
15, 2027 | |
Common
stock warrants February 2023 | |
| 31,563 | | |
$ | 190.0800 | | |
| February
10, 2028 | |
Underwriter
warrants February 2023 | |
| 1,933 | | |
$ | 237.6000 | | |
| February
8, 2028 | |
Common
stock private placement warrants June 2023 | |
| 28,409 | | |
$ | 12.4000 | | |
| June
21, 2029 | |
Placement
agent warrants June 2023 | |
| 852 | | |
$ | 118.7824 | | |
| December
30, 2026 | |
Common
stock warrants October 2023 | |
| 354,994 | | |
$ | 9.6000 | | |
| October
27, 2028 | |
Pre-funded
warrants October 2023 | |
| 99,687 | | |
$ | 0.0008 | | |
| — | |
Underwriter
warrants October 2023 | |
| 10,664 | | |
$ | 16.0000 | | |
| October
24, 2028 | |
Placement
agent warrants June 2024 | |
| 14,142 | | |
$ | 14.8800 | | |
| June
19, 2029 | |
Common
stock warrants June 2024 | |
| 703,125 | | |
$ | 12.4000 | | |
| June
21, 2029 | |
Common
stock warrants November 2024 | |
| 2,222,222 | | |
$ | 4.5000 | | |
| November
7, 2029 | |
Common
stock registered direct warrants December 2024 | |
| 1,085,325 | | |
$ | 2.1000 | | |
| December
9, 2029 | |
Common
stock PIPE warrants December 2024 | |
| 673,000 | | |
$ | 2.1000 | | |
| December
9, 2029 | |
Pre-funded
warrants December 2024 | |
| 545,500 | | |
$ | 0.0001 | | |
| — | |
Total | |
| 5,789,600 | | |
| | | |
| | |
Due
to beneficial ownership limitations, 187,500
shares of common stock related to warrants that were exercised in June 2024 through the inducement offer were being held in
abeyance. During the three months ended December 31, 2024, 32,375
of these shares of common stock were released from abeyance, resulting in 155,125 shares of common stock held in abeyance as of December 31, 2024.
During
the three months ended December 31, 2024, 2,419 warrants were net share settled, resulting in the issuance of 1,209 shares of common
stock, and 1,273,436 pre-funded warrants were exercised on a cash basis for de minimis proceeds.
During
the three months ended December 31, 2023, 3,590 warrants were net share settled, resulting in the issuance of 1,795 shares of common
stock, and 4,302 warrants were abandoned by the warrant holder.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
7.
Share-Based Compensation
In April 2020, the Company adopted the
2020 Omnibus Equity Incentive Plan (the “Plan”). There were 5
shares available for issuance under the Plan as of December 31, 2024. On January 1, 2025, the total number
of shares authorized under the Plan increased to 120,302. The Plan increases the amount of shares issuable under
the Plan by four percent of the outstanding shares of common stock at each January 1, each year. The Plan permits the granting of share-based
awards, including stock options, restricted stock units and awards, stock appreciation rights and other types of awards as deemed appropriate,
in each case, in accordance with the terms of the Plan. The terms of the awards are determined by the Company’s Board of Directors.
Restricted
stock units and awards
On
January 1, 2024, 9,175 restricted stock units (“RSUs”) and 7,977 restricted stock awards (“RSAs”) were granted,
100% of which vested on January 1, 2025. Any unvested RSUs or RSAs will be forfeited upon termination of services. The fair value of
an RSU or RSA is equal to the fair market value of the Company’s common stock on the date of grant. RSU and RSA expense is amortized
straight-line over the vesting period.
The
Company recorded share-based compensation expense associated with the RSUs and RSAs in its accompanying unaudited interim consolidated
statements of operations as follows:
Schedule
of Share-based Compensation Expense
| |
2024 | | |
2023 | |
| |
Three
Months Ended December 31, | |
| |
2024 | | |
2023 | |
Research
and development | |
$ | 28,268 | | |
$ | 24,554 | |
General
and administrative | |
| 32,127 | | |
| 25,451 | |
Share-based
compensation | |
$ | 60,395 | | |
$ | 50,005 | |
The
following table summarizes RSU activity under the Plan:
Schedule
of Restricted Stock Units Activity
| |
| | |
Weighted | |
| |
| | |
Average
Grant | |
| |
RSU | | |
Date
Fair Value | |
Unvested
balance at December 31, 2024 | |
| 9,175 | | |
$ | 14.08 | |
During
the three months ended December 31, 2024, there were no RSUs granted, vested or forfeited. As of December 31, 2024, there was
no unrecognized compensation expense relating to unvested RSUs granted.
The
following table summarizes RSA activity under the Plan:
Schedule
of Restricted Stock Awards Activity
| |
| | |
Weighted | |
| |
| | |
Average
Grant | |
| |
RSA | | |
Date
Fair Value | |
Unvested
balance at December 31, 2024 | |
| 7,977 | | |
$ | 14.08 | |
During
the three months ended December 31, 2024, there were no RSAs granted, vested or forfeited. As of December 31, 2024, there was
no unrecognized compensation expense relating to unvested RSAs granted.
8.
Subsequent Events
The
Company has evaluated subsequent events from the balance sheet date through February 13, 2025, the date at which the unaudited interim
consolidated financial statements were available to be issued.
Subsequent to December 31, 2024, the Company
sold 58,270 shares of common stock pursuant to the Purchase Agreement for net proceeds of $0.1 million.
The
Company received preliminary approval of its application to sell up to $0.8 million of its New Jersey state net operating losses through
the Program (see Note 1). In February 2025, the Company identified a buyer. As outlined in the Program, although the sale has been approved
and a buyer identified, the Company must still execute an arrangement with such buyer to consummate a sale of the state net operating
losses.
On
February 10, 2025, Jay Cross submitted his resignation as our Chief Financial Officer, effective February 21, 2025. In connection
with Mr. Cross’s resignation, on February 12, 2025, the Company’s board of directors (the “Board”) appointed
Donald Griffith, CPA, the Company’s current Controller and a member of the Board, to succeed Mr. Cross as its Chief Financial
Officer effective February 21, 2025.
On
February 12, 2025, Stephen McAndrew, Ph.D., the Company’s Senior Vice President of Business Development, was appointed as
the Company’s Chief Business Officer. In connection with his appointment, Dr. McAndrew entered into an employment agreement with
the Company, dated February 12, 2025 (the “McAndrew Agreement”). Dr. McAndrew’s employment as the Company’s Chief
Business Officer will commence on February 17, 2025. Pursuant to the McAndrew Agreement, Dr. McAndrew is entitled to, among other things,
(i) an annual gross base salary of $330,000 (“Base Salary”) and (ii) eligibility for a performance-based cash bonus of up
to 35% of the Base Salary, as determined by the Board.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis of our financial condition and results of operations should be read together with our financial statements
and the related notes and the other financial information included elsewhere in this Quarterly Report. This discussion contains forward-looking
statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking
statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report, particularly those
under “Risk Factors.”
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations,
assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which
may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future
results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of
historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our
use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,”
“would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,”
“continue,” “plan,” “point to,” “project,” “predict,” “could,”
“intend,” “target,” “potential” and other similar words and expressions of the future.
There
are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking
statement made by us. These factors include, but are not limited to:
| ● | our
lack of operating history and history of operating losses; |
| | |
| ● | our
need for significant additional capital and our ability to satisfy our capital needs; |
| | |
| ● | our
ability to complete required clinical trials of our products and obtain approval from the
U.S. Food and Drug Administration (the “FDA”) or other regulatory agents in different
jurisdictions; |
| | |
| ● | our
ability to maintain the listing of our common stock on The Nasdaq Capital Market; |
| | |
| ● | our
ability to maintain or protect the validity of our patents and other intellectual property; |
| | |
| ● | our
ability to retain key executive members; |
| | |
| ● | our
ability to internally develop new inventions and intellectual property; |
| | |
| ● | interpretations
of current laws and the passage of future laws; |
| | |
| ● | acceptance
of our business model by investors; |
| | |
| ● | the
emergence and effect of competing or complementary products, including the ability of our
future products to compete effectively; |
| | |
| ● | the
accuracy of our estimates regarding expenses and capital requirements; and |
| | |
| ● | our
ability to adequately support growth. |
The
foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or
risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements.
Please see “Part II - Item IA - Risk Factors” for additional risks which could adversely impact our business and financial
performance.
All
forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue
reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by
reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking
statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections
in good faith and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections
will result or be achieved or accomplished.
Overview
Sonnet
BioTherapeutics Holdings, Inc. (“Sonnet,” “we,” “us,” “our” or the “Company”),
is a clinical stage, oncology-focused biotechnology company with a proprietary platform for innovating biologic medicines of single or
bifunctional action. Known as FHAB™ (Fully Human Albumin Binding), the technology utilizes a fully human single-chain
variable fragment (scFv) that binds to and “hitchhikes” on serum albumin for transport to target tissues. We designed the
construct to improve drug accumulation in solid tumors, as well as to extend the duration of activity in the body. FHAB development
candidates can be produced in mammalian cell culture, which enables glycosylation of the interleukins, thereby reducing the risk of immunogenicity,
as well as E. coli. We believe our FHAB technology, for which we received an initial U.S. patent in June 2021 and a continuation
of such patent in June 2024, is a distinguishing feature of our biopharmaceutical platform. The approach is well suited for future drug
development across a range of human disease areas, including in oncology, autoimmune, pathogenic, inflammatory, and hematological conditions.
Our
current internal pipeline development activities are focused on cytokines, which are a class of cell signaling molecules that serve as
potent immunomodulatory agents. Working both independently and synergistically, specific cytokines have shown the ability to modulate
the activation and maturation of immune cells to help fight cancer and pathogens. However, because they do not preferentially accumulate
in specific tissues and are quickly eliminated from the body, the conventional approach to achieving a treatment effect with cytokine
therapy typically requires the administration of high and frequent doses. This can result in the potential for systemic toxicity, which
poses challenges to the therapeutic application of this class of drugs.
Our
lead proprietary asset, SON-1010, is a single-chain version of human Interleukin 12 (“IL-12”), covalently linked to the FHAB
construct, for which we are pursuing clinical development in solid tumor indications, including ovarian cancer, non-small cell lung cancer
and head and neck cancer. In March 2022, the FDA cleared our Investigational New Drug (“IND”) application for SON-1010. This
allowed us to initiate a U.S. clinical trial (SB101) in oncology patients with solid tumors during the second calendar quarter of 2022.
In September 2021, we created a wholly-owned Australian subsidiary, SonnetBio Pty Ltd (“Subsidiary”), for the purpose of
conducting certain clinical trials. We received approval and initiated an Australian clinical study (SB102) of SON-1010 in healthy volunteers
during the third calendar quarter of 2022. Interim safety and tolerability data from the SB101 and SB102 studies were reported in April
2023.
In
January 2023, we announced a collaboration agreement with Roche for the clinical evaluation of SON-1010 with atezolizumab (Tecentriq®).
The companies have entered into a Master Clinical Supply Agreement (“MCSA”), along with associated Quality and Safety Agreements,
to study the safety and efficacy of the combination of SON-1010 and atezolizumab in a platinum-resistant ovarian cancer (“PROC”)
patient setting. Further, the companies will provide SON-1010 and atezolizumab, respectively, for use in the Phase 1b/Phase 2a combination
safety, dose-escalation, and efficacy study (SB221). Part 1 of this 2-part study was approved in June 2023 by the local Human Research
Ethics Committee in Australia under CT-2023-CTN-01399-1 and the Therapeutic Goods Administration has been notified. In August 2023, the
FDA accepted the IND for the use of SON-1010 in ovarian cancer. The SB221 trial consists of a modified 3+3 dose-escalation design in
Part 1 to establish the maximum tolerated dose (“MTD”) of SON-1010 with a fixed dose of atezolizumab. Clinical benefit in
PROC will be confirmed in an expansion group to establish the recommended Phase 2 dose (“RP2D”). Part 2 of the study will
then investigate SON-1010 in combination with atezolizumab versus the standard of care (‘SOC”) for PROC in a randomized comparison
to show proof-of-concept (“POC”).
In
January 2025, we announced an expansion of our Phase 1 SB101 clinical study of SON-1010 to add a new cohort to evaluate its effect in
combination with trabectedin (Yondelis®), following the successful completion of monotherapy dose escalation. Trabectedin
is an alkylating DNA-binding agent that was approved as a second-line treatment in early 2024 for patients with unresectable, metastatic
liposarcoma or leiomyosarcoma who have received a prior anthracycline-containing regimen. It is also known to activate tumor macrophages
into a pro-inflammatory phenotype. We believe that SON-1010 has the potential to complement that activity by activating the NK and T
cells in the TME to secrete more interferon-gamma (IFNγ), which is considered to be important for anti-tumor control.
We
acquired the global development rights to our most advanced compound, SON-080, a fully human version of Interleukin 6 (“IL-6”),
in April 2020 through our acquisition of the outstanding shares of Relief Therapeutics SA. We are advancing SON-080 in target indications
of Chemotherapy-Induced Peripheral Neuropathy (“CIPN”) and Diabetic Peripheral Neuropathy (“DPN”). We received
approval to initiate an ex-U.S. Phase 1b/2a study with SON-080 in CIPN in July 2022. Enrollment of the first portion of the SB211 study
in CIPN has been completed, and the Data Safety Monitoring Board (“DSMB”) completed its review of
the preliminary safety data during the first calendar quarter of 2024, clearing the trial to proceed to Part 2. Following the completion
of the DSMB review, we announced initial safety data from the CIPN study. The objective will be to analyze the data and to consider initiating
a Phase 2 study, pending the outcome of any partnering activity.
On
October 8, 2024, we entered into a license agreement (the “Alkem Agreement”) with Alkem Laboratories Limited (“Alkem”)
for the development and commercialization of SON-080 in DPN and/or CIPN in India. Pursuant to the terms of the Alkem Agreement, Alkem
will bear the cost of, and be responsible for, among other things, conducting clinical studies, preparing and filing applications for
regulatory approval aiming at commercializing SON-080 in the DPN Field in India.
Pursuant
to a license agreement (the “New Life Agreement”) we entered into with New Life Therapeutics Pte, Ltd. (“New
Life”) of Singapore in May 2021, we agreed to be jointly responsible for developing SON-080 in DPN with New Life, with the
objective to analyze the data and to consider initiating a Phase 2 study, pending the outcome of any partnering activity. We were
informed by New Life that is has elected to move its business in a different direction. On December 2, 2024, New Life provided
written notice to us of its intention to exercise its right to give back the rights with respect to the Products under the New Life
Agreement (the “Give Back Option”) under the New Life Agreement, subject to the negotiation and mutual agreement of the
terms of such Give Back Option by us and New Life. We are negotiating the terms of the Give Back Option with New Life. If we and New Life are unable to reach a mutual
agreement on such terms, the Give Back Option will expire unexercised, New Life will retain the rights granted subject to the terms and
conditions of the New Life Agreement and the New Life Agreement will remain in effect unless otherwise terminated by either us or New
Life pursuant to the terms and conditions of the New Life Agreement.
SON-1210
(IL12-FHAB-IL15), our lead bifunctional construct, combines FHAB with single-chain human IL-12 and human Interleukin
15 (“IL-15”). This compound is being developed for solid tumor indications, including colorectal and pancreatic cancer. In
February 2023, we announced the successful completion of two IND-enabling toxicology studies with SON-1210 in non-human primates.
In August 2024, we entered into a Master Clinical Collaboration Agreement (the “SOC Agreement”) with the Sarcoma Oncology
Center (“SOC”) to advance the development of SON-1210. An Innovative Immuno Oncology Consortium (“IIOC”) that
is funded by the SOC will conduct an investigator-initiated Phase 1b/2a study of SON-1210 in pancreatic cancer. In November 2024, the
IIOC submitted a pre-IND package to FDA. Based on the FDA feedback, preparations for the full IND submission package are underway.
SON-1411
(IL18-FHAB-IL12) is a bifunctional combination of human Interleukin 18 (“IL-18”), which was modified to resist
interaction with the IL-18 inhibitor binding protein, and single-chain human IL-12 for solid tumor cancers. Cell line development and
process development are ongoing, with early experimental drug supply suitable for formulation and analytical method development activities.
After some delays in 2024, activities will continue through 2025 with the potential to generate a drug suitable for preclinical studies
and subsequent human studies.
We
have completed sequence confirmation for SON-3015 (anti-IL6-FHAB-anti-TGFβ). Early-stage bifunctional drug has been generated
and is being stored for future use in in vivo mice studies. We have elected to place the SON-3015 development program on hold for expense
reduction purposes.
We
have incurred recurring operating losses and negative cash flows since inception. Our ability to generate product or licensing revenue
sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of
our current or future product candidates. Our net losses were $3.2 million and $1.2 million for the three months ended December
31, 2024 and 2023, respectively. As of December 31, 2024, we had cash of $4.9 million. We expect to continue to incur significant
expenses and increasing operating losses for at least the next several years. We expect that our expenses and capital requirements will
increase in connection with our ongoing activities, particularly if and as we:
| ● | conduct
additional clinical trials for product candidates; |
| | |
| ● | continue
to discover and develop additional product candidates; |
| | |
| ● | acquire
or in-license other product candidates and technologies; |
| | |
| ● | maintain,
expand and protect our intellectual property portfolio; |
| | |
| ● | hire
additional clinical, scientific and commercial personnel; |
| | |
| ● | establish
a commercial manufacturing source and secure supply chain capacity sufficient to provide
commercial quantities of any product candidates for which we may obtain regulatory approval; |
| | |
| ● | seek
regulatory approval for product candidates that successfully complete clinical trials; |
| | |
| ● | establish
a sales, marketing and distribution infrastructure to commercialize any products for which
we may obtain regulatory approval; and |
| | |
| ● | add
operational, financial and management information systems and personnel, including personnel
to support our product development and planned future commercialization efforts, as well
as to support our operation as a public reporting company. |
We
will not generate revenue from product sales, if any, unless and until we receive licensing revenue and/or successfully complete clinical
development and obtain regulatory approval for our product candidates. If we obtain regulatory approval for any of our product candidates
and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our internal commercialization
capability to support product sales, marketing and distribution. We will continue to incur significant costs associated with operating
as a public company.
As
a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such
time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity,
including sales pursuant to our ChEF Purchase Agreement (the “Purchase Agreement”) with Chardan Capital Markets LLC (“Chardan”)
related to a “ChEF,” Chardan’s committed equity facility (the “Facility”), debt financings or other capital
sources, which may include collaborations with other companies or other strategic transactions. We may not be able to raise additional
funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter
into such agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization
of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.
Because
of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased
expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not
become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis or raise additional capital
or enter into collaboration or license agreements, then we may be unable to continue our operations at planned levels and be forced to
reduce or terminate operations.
Since
our inception in 2015, we have devoted substantially all of our efforts and financial resources to organizing and staffing the Company,
business planning, raising capital, acquiring or discovering product candidates and securing related intellectual property rights and
conducting discovery, research and development activities for product candidates. We do not have any products approved for sale and have
not generated any revenue from product sales. We have funded our operations to date primarily with proceeds from sales of common stock,
warrants and proceeds from the issuance of convertible debt.
Lead
Clinical Programs Update
SON-1010
Phase
1 Trial (SB101 Trial): Solid Tumors (Monotherapy)
This
first-in-human study is primarily designed to evaluate the safety of multiple ascending doses of SON-1010 in cancer patients and is being
conducted at several sites across the United States. We recently announced an expansion of this trial to study the combination of SON-1010
with trabectedin (Yondelis®) in certain advanced soft-tissue sarcomas (STS), following the successful completion of monotherapy dose escalation. Enrollment
in this cohort is underway and is expected to be completed in H1 calendar year 2025. Topline safety data of the combination with trabectedin
is expected in H2 calendar year 2025. No new safety concerns have been reported to date.
Phase
1b/2a Trial (SB221 Trial): PROC (Combo with Atezolizumab)
The
second trial is a global Phase 1b/2a multicenter, dose-escalation and randomized proof-of-concept study to assess the safety, tolerability,
PK, PD, and efficacy of SON-1010 administered subcutaneously (SC), either alone or in combination with atezolizumab given intravenously
(IV). Enrollment remains ongoing and an update on safety in that trial is expected in Q1 calendar year 2025.
Program
Highlights:
|
● |
PK
data reveals about 10-fold extended half-life for SON-1010 compared with rhIL-12 and suggests tumor targeting by the FHAB. |
|
● |
Dose-related,
controlled, and prolonged IFNγ response. |
|
● |
The SB101 trial and the SB221 trial have collectively enrolled 70 subjects, with 10 of 21 evaluable patients (48%) with cancer suggesting clinical benefit of SON-1010 monotherapy (Stable Disease at 4 months).
One patient had
a partial response by RECIST criteria (45% decrease from baseline) to SON-1010 at the highest dose. |
|
● |
Patients
have received up to 25 cycles of SON-1010 as monotherapy and up to 10 cycles of SON-1010 with atezolizumab (Tecentriq®)
without dose-limiting toxicity at any dose level. |
|
● |
Toxicity
is minimized in both trials with the use of a ‘desensitizing’ first dose that takes advantage of the known tachyphylaxis
with rhIL-12, which allows higher maintenance doses and potential improvements in efficacy. |
|
●
● |
Favorable
safety profile.
Dose
escalation has been completed and the MTD was established at 1200 ng/kg. |
|
● |
The final 1200 ng/kg dose-escalation cohort was increased in size to 6 patients to enhance the assessment of PK and
PD at the MTD. |
|
● |
The safety and toxicity profile that has developed is typical for a Phase 1 oncology trial, with the majority of
adverse events (AEs) being reported as mild. All AEs seen to date have been transient, with no evidence of cytokine release syndrome. |
Upcoming
Milestones:
| ● |
Phase
1: Solid Tumors (Monotherapy) |
| |
|
○ | H1
calendar year 2025: Topline Efficacy Data |
|
● |
Phase
1b/2a: PROC (Combo with Atezolizumab) |
|
|
|
○ | Q1
calendar year 2025: Additional Safety Data |
|
|
|
○ | H2
calendar year 2025: RP2D & Topline Efficacy |
|
● |
Phase
1: Solid Tumors (Combo with Trabectedin) |
|
|
|
○ |
H2
calendar year 2025: Topline Efficacy Data |
SON-080
Phase
1b/2a Trial (SB211 Trial): Chemotherapy Induced Peripheral Neuropathy (CIPN)
The
SB211 study was a double-blind, randomized, controlled trial of SON-080 conducted at two sites in Australia in patients with persistent
CIPN using a new proprietary version of recombinant human Interleukin-6 (rhIL-6) that builds upon previous work with atexakin alfa. The
goal of the first portion of the SB211 study was to confirm safety and tolerability before continued development in Phase 2. As previously
announced in March 2024, a data and safety monitoring board reviewed the unblinded safety and tolerability of SON-080 in the first nine
patients and concluded that the symptoms were tolerable in the initial patients and the study could proceed to Phase 2.
In
October 2024, we entered into the Alkem Agreement with Alkem for the research, development, manufacturing, marketing, and commercialization
of our SON-080 molecule for the treatment of DPN in India and the manufacturing, marketing, and commercialization of SON-080 for CIPN
and autonomic neuropathy in India. Alkem will conduct all clinical trials it believes appropriate to obtain regulatory approval in India
of SON-080 for the treatment of DPN. Subsequent to the partnership established with Alkem, preparations are being made to support initiation of a Phase
2 clinical trial in DPN, a mechanistically synergistic and larger, high-value indication with unmet medical need.
Phase
1b Data Highlights:
|
● |
SON-080
demonstrated to be well-tolerated at both 20 µg and 60 µg/dose, which was about 10-fold lower than the MTD for IL-6 that
was established in previous clinical evaluations. |
|
● |
Pain
and quality of life survey results suggest the potential for rapid improvement of peripheral neuropathy symptoms and post-dosing
durability with both doses, compared to placebo controls. |
Upcoming
Milestones:
| ● | H2 calendar year 2025: Initiation of Phase 2 trial |
SON-1210:
Proprietary, Bifunctional Version of Human Interleukins 12 (IL-12) and 15 (IL-15), Configured Using Our FHAB Platform, in
Combination with Chemotherapy for the Treatment of Advanced Solid Tumors and Metastatic Pancreatic Cancer
In
August 2024, we entered into the SOC Agreement with the SOC to conduct an investigator-initiated Phase 1/2a clinical study to
evaluate SON-1210 in combination with several chemotherapeutic agents including but not limited to NALIRIFOX (the combination of
liposomal irinotecan, 5-fluorouracil/leucovorin, and oxaliplatin) for the specific treatment of metastatic pancreatic cancer. The
NALIRIFOX regimen is U.S. FDA-approved for the treatment of metastatic pancreatic cancer in the front-line and refractory settings. We expect to submit the IND for SON-1210 in Q1 calendar year 2025.
Upcoming
Milestones:
|
● |
Q1
calendar year 2025: IND Submission |
|
● |
H1
calendar year 2025: 1st Patient Dosed in Investigator-Initiated Phase 1/2a Study |
Recent
Developments
Patent
Update
On
January 22, 2025, the European Patent Office granted our Patent No. EP3583125 B1, entitled “Albumin Binding Domain Fusion
Proteins,” which covers our FHAB technology and includes therapeutic fusion proteins that utilize FHAB
for tumor targeting and retention, and provide extended pharmacokinetics (PK). The EU patent carries a term effective until February
20, 2038. In addition to the U.S. and EU, our global intellectual property coverage now extends to China, Japan, Russia
and New Zealand.
Reverse
Stock Split
On
September 30, 2024, we effected a reverse stock split of our issued and outstanding common stock at a ratio of 1-for-8 (the “Reverse
Stock Split”). Shares of common stock underlying outstanding stock options and other equity instruments convertible into common
stock were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with
the terms of the agreements governing such securities in connection with the Reverse Stock Split. No fractional shares were issued in
connection with the Reverse Stock Split. Stockholders who would otherwise be entitled to a fractional share of common stock instead received
a proportional cash payment. All of our historical share and per share information related to issued and outstanding common stock and
outstanding options and warrants exercisable for common stock included in this Quarterly Report on Form 10-Q have been adjusted, on a
retroactive basis, to reflect the Reverse Stock Split.
Management
Updates
On
February 10, 2025, Jay Cross submitted his resignation as our Chief Financial Officer, effective February 21, 2025. In connection with
Mr. Cross’s resignation, on February 12, 2025, our board of directors (the “Board”) appointed Donald Griffith,
CPA, our current Controller and a member of the Board, to succeed Mr. Cross as our Chief Financial Officer effective February 21, 2025.
On
February 12, 2025, Stephen McAndrew, Ph.D., our Senior Vice President of Business Development, was appointed as our Chief Business
Officer. In connection with his appointment, Dr. McAndrew entered into an employment agreement with the Company, dated February 12,
2025. Dr. McAndrew’s employment as our Chief Business Officer will commence on February 17, 2025.
New
Jersey NOL
In
February 2025, we received preliminary approval of our application to sell up to $0.8 million of our New Jersey state net operating
losses through the Technology Business Tax Certificate Transfer Program (the “Program”), subject to execution of such sale.
Components
of Results of Operations
Collaboration
Revenue
Collaboration revenue was earned from the license
arrangement entered into with New Life in May 2021, which granted New Life rights to an exclusive license (with the right to sublicense)
to develop and commercialize pharmaceutical preparations containing a specific recombinant human IL-6, SON-080 (the “Compound”)
(such preparations, the “Products”) for the prevention, treatment or palliation of diabetic peripheral neuropathy in humans
(the “DPN Field”) in the Exclusive Territory. We identified the following obligations under the arrangement: (i) License to
develop, market, import, use and commercialize the Product in the Field in the Exclusive Territory (the “New Life License”);
and (ii) transfer of know-how and clinical development and regulatory activities (“R&D Activities”). We determined that
the New Life License and the R&D Activities are not distinct from each other and, therefore, combined these material promises into
a single performance obligation. Under this agreement, we received upfront cash payments totaling $1.0 million, which were fully allocated
to the single performance obligation and were recognized over the estimated performance period of R&D services, which ended in the
first fiscal quarter of 2024.
Collaboration revenue was also
earned from the Alkem Agreement entered into in October 2024, which granted Alkem rights to an exclusive license
(with the right to sublicense) to research, develop, manufacture, import, export, market, use and commercialize pharmaceutical
products containing our IL-6 (SON-080) asset (or any derivatives, fragments or conjugates thereof) (the “Compounds”)
(such products, the “Products”) for the treatment of DPN (the “DPN Field”) and to manufacture, import,
export, market, use and commercialize Products for the treatment of CIPN and autonomic neuropathy (together with the DPN Field, the
“Fields”) in India. We identified the following obligations under the Alkem Agreement: (i) License to research, develop,
market, import, use and commercialize the Product in the DPN Field in India (the “Alkem License”) and (ii) supply of
Compound for a Phase 2 clinical trial (“Supply”). We determined that the Alkem License and Supply are not distinct from
each other and, therefore, combined these material promises into a single performance obligation. Under the Alkem Agreement, we are
entitled to upfront cash payments totaling $1.0 million, which have been fully allocated to the single performance obligation and
were recognized at the point-in-time at which the Company transferred the Alkem License and Supply to Alkem.
Operating
Expenses
Research
and Development Expenses
Research
and development expenses consist primarily of costs incurred in connection with the discovery and development of our product candidates.
We expense research and development costs as incurred and such costs include:
| ● | employee-related
expenses, including salaries, share-based compensation and related benefits, for employees
engaged in research and development functions; |
| ● | expenses
incurred in connection with the preclinical and clinical development of our product candidates,
including under agreements with third parties, such as consultants and clinical research
organizations; |
| ● | the
cost of manufacturing drug products for use in our preclinical studies and clinical trials,
including under agreements with third parties, such as consultants and contract manufacturing
organizations; |
| ● | facilities,
depreciation and other expenses, which include direct or allocated expenses for rent and
maintenance of facilities and insurance; |
| ● | costs
related to compliance with regulatory requirements; and |
| ● | payments
made under third-party licensing agreements. |
We
recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided
by our service providers. This process involves reviewing open contracts and purchase orders, communicating with their personnel to identify
services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the
service when we have not yet been invoiced or otherwise notified of actual costs. Nonrefundable advance payments for goods or services
to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized
as an expense when the goods have been delivered or the services have been performed.
Our
direct research and development expenses consist primarily of external costs, such as fees paid to outside consultants, contract research organizations, contract manufacturing organizations and
research laboratories in connection with preclinical development, process development, manufacturing and clinical development activities.
Our direct research and development expenses also include fees incurred under third-party license agreements. We do not allocate employee
costs and costs associated with discovery efforts, laboratory supplies and facilities, including depreciation or other indirect costs,
to specific product candidates because these costs are deployed across multiple programs and as such, are not separately classified.
We use internal resources primarily to conduct our research and discovery as well as for managing preclinical development, process development,
manufacturing and clinical development activities. These employees work across multiple programs and therefore, we do not track costs
by product candidate.
We
will continue to incur research and development expenses for the foreseeable future as we attempt to advance development of our product
candidates. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or
know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of our current pipeline
or any future product candidates we may develop due to the numerous risks and uncertainties associated with clinical development, including
risks and uncertainties related to:
| ● | the
timing and progress of preclinical and clinical development activities; |
| | |
| ● | the
number and scope of preclinical and clinical programs that we decide to pursue; |
| | |
| ● | our
ability to maintain our current research and development programs and to establish new ones; |
| | |
| ● | establishing
an appropriate safety profile with investigational new drug-enabling studies; |
| | |
| ● | successful
patient enrollment in, and the initiation and completion of, clinical trials; |
| | |
| ● | the
successful completion of clinical trials with safety, tolerability and efficacy profiles
that are satisfactory to the FDA or any comparable foreign regulatory authority; |
| | |
| ● | the
receipt of regulatory approvals from applicable regulatory authorities; |
| | |
| ● | the
timing, receipt and terms of any marketing approvals from applicable regulatory authorities; |
| | |
| ● | our
ability to establish new licensing or collaboration arrangements; |
| ● | establishing
agreements with third-party manufacturers for clinical supply for our clinical trials and
commercial manufacturing, if any of our product candidates is approved; |
| | |
| ● | development
and timely delivery of clinical-grade and commercial-grade drug formulations that can be
used in our clinical trials and for commercial launch; |
| | |
| ● | obtaining,
maintaining, defending and enforcing patent claims and other intellectual property rights; |
| | |
| ● | launching
commercial sales of product candidates, if approved, whether alone or in collaboration with
others; |
| | |
| ● | maintaining
a continued acceptable safety profile of the product candidates following approval; and |
| | |
| ● | the
potential impact of health epidemics or outbreaks of communicable diseases on operations which
may affect among other things, the timing of clinical trials, availability of raw materials,
and the ability to access and secure testing facilities. |
A
change in the outcome of any of these variables with respect to the development of our product candidates could significantly change
the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval
for any of our product candidates.
General
and Administrative Expenses
General
and administrative expenses consist primarily of salaries and related costs for personnel, including share-based compensation, in executive,
finance and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as
well as professional fees for legal, patent, consulting, accounting, and audit services.
Our
general and administrative expenses will increase in the future as we increase our headcount to support continued research activities
and development of product candidates. We will continue to incur increased accounting, audit, legal, regulatory, compliance and director
and officer insurance costs as well as investor and public relations expenses associated with being a public company.
Foreign
Exchange (Loss) Gain
Foreign
exchange (loss) gain consists of exchange rate changes on transactions denominated in currencies other than the U.S.
dollar.
Provision for Income Taxes
Provision for income taxes consists of foreign withholding
taxes incurred on collaboration revenue.
Results
of Operations
Comparison
of the Three Months Ended December 31, 2024 and 2023
The
following table summarizes our results of operations for the three months ended December 31, 2024 and 2023:
| |
Three Months Ended December 31, | | |
| |
| |
2024 | | |
2023 | | |
Change | |
Collaboration revenue | |
$ | 1,000,000 | | |
$ | 18,626 | | |
$ | 981,374 | |
Operating expenses: | |
| | | |
| | | |
| | |
Research and development | |
| 1,886,076 | | |
| 644,042 | | |
| 1,242,034 | |
General and administrative | |
| 1,963,346 | | |
| 653,455 | | |
| 1,309,891 | |
Total operating expenses | |
| 3,849,422 | | |
| 1,297,497 | | |
| 2,551,925 | |
Loss from operations | |
| (2,849,422 | ) | |
| (1,278,871 | ) | |
| (1,570,551 | ) |
Foreign exchange (loss) gain | |
| (152,884 | ) | |
| 110,362 | | |
| (263,246 | ) |
Loss before provision from income taxes | |
| (3,160,706 | ) | |
| (1,168,509 | ) | |
| (1,992,197 | ) |
Provision for income taxes | |
| (158,400 | ) | |
| — | | |
| (158,400 | ) |
Net loss | |
$ | (3,319,106 | ) | |
$ | (1,168,509 | ) | |
$ | (2,150,597 | ) |
Collaboration
Revenue
We
recognized $1.0 million of revenue related to the Alkem Agreement during the three months ended December 31, 2024, compared to
$18,626 from the New Life Agreement during the three months ended December 31, 2023. Revenue of $1.0 million for the three
months ended December 31, 2024 was due to our transfer of the Alkem License and Supply to Alkem during the first quarter of fiscal
2025. Revenue of $18,626 for the three months ended December 31, 2023 was due to our completion of R&D Activities related to New
Life during the first quarter of fiscal 2024.
Research
and Development Expenses
Research
and development expenses were $1.9 million for the three months ended December 31, 2024, compared to $0.6 million for the three
months ended December 31, 2023. The increase of $1.2 million was primarily due to the cancellation of accrued but unpaid bonuses
that had been awarded for fiscal years 2022 and 2023 in the amount of $1.0 million during the three months ended December 31, 2023.
General
and Administrative Expenses
General
and administrative expenses were $2.0 million for the three months ended December 31, 2024, compared to $0.7 million for the three
months ended December 31, 2023. The increase of $1.3 million was primarily due to the cancellation of accrued but unpaid bonuses
that had been awarded for fiscal years 2022 and 2023 in the amount of $0.9 million during the three months ended December 31, 2023,
and an increase in legal and consulting fees related to the Alkem Agreement executed during the three months ended December 31, 2024.
Provision for Income Taxes
Provision for income taxes was $0.2 million for
the three months ended December 31, 2024 as a result of collaboration revenue earned under the Alkem Agreement.
Liquidity
and Capital Resources
We
have funded operations to date primarily with proceeds from sales of common stock, warrants and proceeds from the issuance of convertible
debt. We will likely offer additional securities for sale in response to market conditions or other circumstances, including sales to
Chardan pursuant to the Facility, if we believe such a plan of financing is required to advance our business plans and is in the best
interests of our stockholders. There is no certainty that equity or debt financing will be available in the future or that it will be
at acceptable terms and at this time, it is not possible to predict the outcome of these matters.
We
have incurred net losses of $3.2 million and $1.2 million for the three months ended December 31, 2024 and 2023, respectively. We
expect to continue to incur significant operational expenses and net losses in the upcoming 12 months and beyond. Our net losses may
fluctuate significantly from quarter to quarter and year to year, depending on the stage and complexity of our R&D studies and related
expenditures, the receipt of additional payments on the licensing of our technology, if any, and the receipt of payments under any current
or future collaborations into which we may enter.
We
have evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about our ability
to continue as a going concern. We believe our cash of $4.9 million at December 31, 2024 will fund our projected operations
into July 2025. We also received preliminary approval of our application to sell up to $0.8 million of our New Jersey state net
operating losses through the Technology Business Tax Certificate Transfer Program, subject to execution of such sale. Substantial
additional financing will be needed by us to fund our operations. These factors raise substantial doubt about our ability to
continue as a going concern.
The
following table summarizes our sources and uses of cash for each of the periods presented:
| |
Three
Months Ended December 31, | |
| |
2024 | | |
2023 | |
Net cash used
in operating activities | |
$ | (2,910,246 | ) | |
$ | (3,091,737 | ) |
Net cash
provided by financing activities | |
| 7,622,293 | | |
| 3,838,870 | |
Net
increase in cash | |
$ | 4,712,047 | | |
$ | 747,133 | |
Operating
Activities
During
the three months ended December 31, 2024, we used $2.9 million of cash in operating
activities, which was primarily attributable to our net loss of $3.2 million and a $0.5 million increase in unbilled collaboration revenue
related to the Alkem Agreement, partially offset by a $0.6 million decrease in incentive tax receivable primarily due to the collection
of the incentive tax receivable for fiscal year 2024.
During
the three months ended December 31, 2023, we used $3.1 million of cash in operating
activities, which was primarily attributable to our net loss of $1.2 million, a $2.7 million net decrease in accounts payable and accrued
expenses and other current liabilities primarily due to the cancellation of accrued but unpaid bonuses that had been awarded for fiscal
years 2022 and 2023 and the decrease in research and development expenses; offset by a $0.9 million net decrease in prepaid expenses and
other current assets and incentive tax receivable, primarily related to the collection of the incentive tax receivable for fiscal year
2023.
Financing Activities
During the three months ended December 31,
2024, net cash provided by financing activities was $7.7 million, consisting of net proceeds from the sale of common stock and pre-funded
warrants through a combination of public, registered direct and PIPE offerings, partially offset by the payment of deferred offering costs
of $0.1 million related to the Facility.
During the three months ended December 31,
2023, net cash provided by financing activities was $3.8 million, consisting of net proceeds from the sale of common stock and pre-funded
warrants in a public offering.
Funding
Requirements
We
expect to continue to incur significant expenses in connection with our ongoing activities, particularly as we advance preclinical activities
and clinical trials of product candidates in development. In addition, we expect to continue to incur costs associated with operating
as a public company. The timing and amount of our operating expenditures will depend largely on:
| ● | the
scope, number, initiation, progress, timing, costs, design, duration, any potential delays,
and results of clinical trials and nonclinical studies for our current or future product
candidates; |
| | |
| ● | the
clinical development plans we establish for these product candidates; |
| | |
| ● | the
number and characteristics of product candidates and programs that we develop or may in-license; |
| | |
| ● | the
outcome, timing and cost of regulatory reviews, approvals or other actions to meet regulatory
requirements established by the FDA and comparable foreign regulatory authorities, including
the potential for the FDA or comparable foreign regulatory authorities to require that we
perform more studies for our product candidates than those that we currently expect; |
| | |
| ● | our
ability to obtain marketing approval for product candidates; |
| | |
| ● | the
cost of filing, prosecuting, defending and enforcing patent claims and other intellectual
property rights covering our product candidates; |
| ● | our
ability to maintain, expand and defend the scope of our intellectual property portfolio,
including the cost of defending intellectual property disputes, including patent infringement
actions brought by third parties against us or our product candidates; |
| | |
| ● | the
cost and timing of completion of commercial-scale outsourced manufacturing activities with
respect to product candidates; |
| | |
| ● | our
ability to establish and maintain licensing, collaboration or similar arrangements on favorable
terms and whether and to what extent we retain development or commercialization responsibilities
under any new licensing, collaboration or similar arrangement; |
| ● | the
cost of establishing sales, marketing and distribution capabilities for any product candidates
for which we may receive regulatory approval in regions where we choose to commercialize
our products on our own; |
| | |
| ● | the
success of any other business, product or technology that we acquire or in which we invest; |
| | |
| ● | the
costs of acquiring, licensing or investing in businesses, product candidates and technologies; |
| | |
| ● | our
need and ability to hire additional management and scientific and medical personnel; |
| | |
| ● | the
costs to operate as a public company in the United States, including the need to implement
additional financial and reporting systems and other internal systems and infrastructure
for our business; |
| | |
| ● | market
acceptance of our product candidates, to the extent any are approved for commercial sale; |
| | |
| ● | the
effect of competing technological and market developments; and |
| | |
| ● | the
potential impact of a widespread outbreak of any communicable disease on our clinical trials
and operations. |
Until such time, if ever, as we can generate
substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations,
strategic alliances, and marketing, distribution or licensing arrangements with third parties. To the extent that we raise additional
capital through the sale of equity or convertible debt securities, the ownership interest of ours may be materially diluted, and the terms
of such securities could include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing
and preferred equity financing, if available, may involve agreements that include restrictive covenants that limit our ability to take
specified actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations,
strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights
to technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable
to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required
to delay, reduce or eliminate product development or future commercialization efforts, sell off assets, or grant rights to develop and
market product candidates that we would otherwise prefer to develop and market.
Committed
Equity Facility
On May 2, 2024, we entered into the Purchase
Agreement and a Registration Rights Agreement (the “Registration Rights Agreement”), each with Chardan, related to the Facility.
Pursuant to the Purchase Agreement, we have the right from time to time at our option to sell to Chardan up to $25.0 million in aggregate
gross purchase price of newly issued shares of our common stock, of which $24.9 million is available to be sold as of December 31,
2024. The Facility will allow us to raise primary equity on a periodic basis at our sole discretion depending on a variety of factors
including, among other things, market conditions, the trading price of the common stock, and determinations by us regarding the use of
proceeds of such common stock. The purchase price of the shares of common stock will be determined by reference to the Volume Weighted
Average Price (“VWAP”) of the common stock during the applicable purchase period, less a fixed 4% discount to such VWAP, and
the total shares to be purchased on any day may not exceed 20% of the trading volume of our common stock during the applicable purchase
period. The Purchase Agreement will be effective for a 36-month period ending May 16, 2027, unless earlier terminated upon the terms and
conditions therein. During the three months ended December 31, 2024, we did not sell any shares of common stock pursuant to the Purchase
Agreement. Subsequent to the quarter ended December 31, 2024, 58,270 shares have been issued pursuant to the Purchase Agreement
for aggregate net proceeds to us of $0.1 million.
Alkem
Licensing Agreement
In October 2024, we executed the Alkem Agreement
for the treatment of DPN in India as well as the manufacturing, marketing and commercialization of SON-080 for the treatment of CIPN and
autonomic neuropathy in India. Pursuant to the terms of the Alkem Agreement, Alkem will bear the cost of certain expenses, including conducting
clinical studies, preparing and filing regulatory applications and undertaking other developmental and regulatory activities for commercializing
SON-080 for DPN in India. Alkem will pay us a $1.0 million upfront non-refundable cash payment, of which $0.5 million has been paid, which after tax withholdings resulted in a net payment of $0.4 million,
as well as potential additional milestone payments totaling up to $1.0 million subject to the achievement of certain development and regulatory
milestones. In addition, Alkem is obligated to pay us a royalty equal to a percentage in the low double digits of net sales less Alkem’s
actual cost of goods sold and Alkem’s sales and marketing and related expenses of SON-080 in India until the first commercial sale
of a competitive intermittent low dose IL-6 compound as set forth in the Alkem Agreement.
November
2024 Underwritten Public Offering
On November 7, 2024, we closed a public offering
of common stock and certain warrants through Chardan, as underwriter, for net proceeds of $4.2 million through the issuance and sale of
155,000 shares of our common stock, pre-funded warrants to purchase up to 956,111 shares of common stock, and accompanying common warrants
to purchase up to an aggregate of 2,222,222 shares of our common stock. Each share of common stock and pre-funded warrant to purchase
one share of common stock was sold together with a common warrant to purchase two shares of common stock. The public offering price of
each share of common stock and accompanying common warrant was $4.50 and the public offering price of each pre-funded warrant and accompanying
common warrant was $4.4999. The common warrants were immediately exercisable at a price of $4.50 per share of common stock, expire five
years from the date of issuance and contain an alternative cashless exercise provision. The pre-funded warrants were immediately exercisable
at any time, until exercised in full, at a price of $0.0001 per share of common stock.
December
2024 Registered Direct and PIPE Offering
On December 10, 2024, we closed a registered
direct offering with institutional investors for the issuance and sale of 768,000 shares of our common stock, pre-funded warrants to purchase
up to 317,325 shares of common stock and accompanying warrants to purchase up to an aggregate of 1,085,325 shares of our common stock.
Each share of common stock and pre-funded warrant to purchase one share of common stock was sold together with a common warrant to purchase
one share of common stock. The offering price of each share of common stock and accompanying common warrant was $2.23 and the offering
price of each pre-funded warrant and accompanying common warrant was $2.2299, priced at-the-market under the rules of the Nasdaq Stock
Market. The registered direct warrants were immediately exercisable at a price of $2.10 per share, expire five years from the date of
issuance and contain an alternative cashless exercise provision. The pre-funded warrants were immediately exercisable at any time, until
exercised in full, at a price of $0.0001 per share of common stock.
We closed a concurrent private placement with
an existing investor for the issuance and sale of 127,500 shares of our common stock, pre-funded warrants to purchase up to 545,500 shares
of common stock and accompanying warrants to purchase up to an aggregate 673,000 shares of our common stock. Each share of common stock
and pre-funded warrant to purchase one share of common stock was sold in the private placement (“PIPE”) together with a common
warrant to purchase one share of common stock. The PIPE offering price of each share of common stock and accompanying common warrant was
$2.23 and the PIPE offering price of each pre-funded warrant and accompanying common warrant was $2.2299, priced at-the-market under the
rules of the Nasdaq Stock Market. The PIPE warrants were immediately exercisable at a price of $2.10 per share, expire five years from
the date of issuance and contain an alternative cashless exercise provision. The pre-funded warrants were immediately exercisable at any
time, until exercised in full, at a price of $0.0001 per share of common stock.
We raised net proceeds of approximately $3.5
million from the registered direct and PIPE offering.
Contractual
Obligations and Commitments
Our contractual obligations as of December 31,
2024 that will affect our future liquidity consist of an operating lease. As of December 31, 2024, we had $87,323 in current operating
lease liability and $23,634 in non-current operating lease liability.
In addition to the operating lease, we have entered
into other contracts in the normal course of business with certain CROs, CMOs and other third-parties for preclinical research studies
and testing, clinical trials and manufacturing services. These contracts do not contain any minimum purchase commitments and are cancellable
upon prior notice. Payments due upon cancellation consist only of payments for services provided and expenses incurred, including non-cancellable
obligations to our service providers, up to the date of cancellation.
Critical
Accounting Policies and Estimates
Our
management’s discussion and analysis of financial condition and results of operations are based on our consolidated financial statements,
which have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make
estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets
and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to
the accrual for research and development expenses. We base our estimates on historical experience, known trends and events, and various
other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.
While
our significant accounting policies are described in more detail in the notes to the unaudited interim consolidated financial statements
included elsewhere in this Form 10-Q, we believe that the following accounting policies are those most critical to the judgments and
estimates used in the preparation of the consolidated financial statements.
Research
and Development Expenses
Research
and development expenses include all direct and indirect costs associated with the development of our biopharmaceutical products. These
expenses include personnel costs, consulting fees, and payments to third parties for research, development and manufacturing services.
These costs are charged to expense as incurred.
At
the end of each reporting period, we compare payments made to third-party service providers to the estimated progress toward completion
of the related project, based on the measure of progress as defined in the contract. Factors we consider in preparing the estimates include
costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of our service providers. Such
estimates are subject to change as additional information becomes available. Depending on the timing of payment to the third-party service
providers and the progress we estimate has been made as a result of the service provided, we will record a prepaid expense or accrued
liability related to these costs. Contingent development or regulatory milestone payments are recognized upon the related resolution
of such contingencies. As of December 31, 2024, we did not make any material adjustments to our prior estimates of accrued research and
development expenses.
Recently
Issued Accounting Pronouncements
A
description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations
is disclosed in Note 2 to the unaudited interim consolidated financial statements included elsewhere in this Form 10-Q.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Not
applicable.
Item
4. Controls and Procedures.
Evaluation
of Disclosure Controls and Procedures
We
evaluated, under the supervision and with the participation of the principal executive officer and principal financial officer, the effectiveness
of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
and Exchange Act of 1934, as amended (“Exchange Act”)) as of December 31, 2024, the end of the period covered by this report
on Form 10-Q. Based on this evaluation, our Chairman, President and Chief Executive Officer (principal executive officer) and our Chief
Financial Officer (principal financial officer) have concluded that our disclosure controls and procedures were effective at the reasonable
assurance level at December 31, 2024.
Disclosure
controls and procedures are designed to provide reasonable assurance that information required to be disclosed by us in the reports that
we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the
SEC’s rules and forms, and (ii) is accumulated and communicated to management, including the principal executive officer and principal
financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure
controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving the desired control objectives. Due to the inherent limitations of control systems, not all misstatements
may be detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns
can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by
collusion of two or more people, or by management override of the control. Controls and procedures can only provide reasonable, not absolute,
assurance that the above objectives have been met.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting during the three months ended December 31, 2024 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings.
We
are subject to various legal proceedings from time to time in the ordinary course of business, which may not be required to be disclosed
under this Item 1. For the three-month period ended December 31, 2024 covered by this Quarterly Report, there have been no reportable
legal proceedings or material developments to previously reported legal proceedings.
Item
1A. Risk Factors.
As
a smaller reporting company, we are not required to provide the information required by this item. However, we direct you to the risk
factors included in the “Risk Factors” section in our Annual Report on Form 10-K for the year ended September 30,
2024 filed with the Securities and Exchange Commission on December 17, 2024.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
a)
Chief Financial Officer Resignation and Appointment
On
February 10, 2025, Jay Cross submitted his resignation as our Chief Financial Officer, effective February 21, 2025. In connection
with Mr. Cross’s resignation, on February 12, 2025, our board of directors (the “Board”) appointed Donald
Griffith, CPA, our current Controller and a member of our Board, to succeed Mr. Cross as our Chief Financial Officer effective February 21, 2025. Mr. Griffith
will continue his duties as a member of our Board.
Mr.
Griffith, age 76, is a certified public accountant with over has 40 years’ experience in finance and accounting. Mr. Griffith
has served as our Controller and as a member of our Board since the closing of the merger (the “Merger”) between the Company
and Sonnet BioTherapeutics, Inc., our wholly-owned operating subsidiary and accounting predecessor (“Prior Sonnet”) in April
2020. Prior to the Merger, Mr. Griffith served on Prior Sonnet’s board of directors from its inception in April 2015, including
as Chairman from April 2015 to June 2018. Mr. Griffith also served as Prior Sonnet’s Financial Controller from January 2019 until
April 2020, and as its Chief Executive Officer and Chief Financial Officer from April 2015 to December 2016. Before joining Prior Sonnet,
Mr. Griffith served as the Chief Financial Officer, Director and Secretary of Oncobiologics Inc. (now Outlook Therapeutics; Nasdaq: OTLK)
(“Oncobiologics”) from 2011 to 2018. In addition, Mr. Griffith is the founder and Partner of Stolz & Griffith, LLC, a
New Jersey accounting firm.
There
are no arrangements or understandings between Mr. Griffith and any other persons pursuant to which Mr. Griffith was selected as an officer
of our Company, Mr. Griffith has no family relationships with any of our Company’s directors or executive officers, and Mr. Griffith
is not a party to and does not have any direct or indirect material interest in any transaction requiring disclosure under Item 404(a)
of Regulation S-K under the Securities Act of 1933, as amended.
Griffith
Employment Agreement
As
previously disclosed, Prior Sonnet entered into an employment agreement with Mr. Griffith on January 1, 2019, setting forth the terms
of his employment as Financial Controller (the “Griffith Agreement”), which agreement was assumed by us at the closing of
the Merger. Pursuant to the Griffith Agreement, Mr. Griffith is entitled to, among other things, (i) an annual prorated gross base salary
of $150,000 and (ii) eligibility for a target bonus equal to 25% of gross salary earned. The Griffith Agreement has no specific term
and constitutes an at-will employment. The terms of the Griffith Agreement continue to govern Mr. Griffith’s employment with us.
The
foregoing description of the Griffith Agreement, does not purport to be complete and is qualified in its entirety by reference to the
full text of the Griffith Agreement, a copy of which is filed herewith as Exhibit 10.5, and is incorporated herein by reference.
Chief
Business Officer Appointment
On
February 12, 2025, Stephen McAndrew, Ph.D., our Senior Vice President of Business Development, was appointed by our Board as our
Chief Business Officer. Dr. McAndrew’s employment as our Chief Business Officer will commence on February 17, 2025.
Dr.
McAndrew, age 71, has served as our Senior Vice President of Business Development since the closing of the Merger. Prior to the Merger,
Dr. McAndrew served as Prior Sonnet’s Senior Vice President of Business Development from October 2019. Before joining Prior Sonnet,
Dr. McAndrew served as the Senior Vice President of Business Strategy & Development at Oncobiologics from March 2014 to October 2019
and as the Vice President of Business Development from February 2012 to March 2014. Prior to Oncobiologics, Dr. McAndrew served in various
business development roles at several biopharmaceutical companies from 2001 to 2011. From March 1993 to December 2001, Dr. McAndrew also
served in various positions of increasing responsibility at Bristol-Myers Squibb Company, including as the Director of Biotechnology
Licensing within the External Science and Technology Department.
Dr.
McAndrew earned his Ph.D. in Molecular and Cellular Biology from Ohio University, an M.S in Molecular Genetics from the State University
of New York at Albany and a B.S from the State University of New York at Oswego.
There
are no arrangements or understandings between Dr. McAndrew and any other persons pursuant to which Dr. McAndrew was selected as an officer
of our Company, Dr. McAndrew has no family relationships with any of our Company’s directors or executive officers, and Dr. McAndrew
is not a party to and does not have any direct or indirect material interest in any transaction requiring disclosure under Item 404(a)
of Regulation S-K under the Securities Act of 1933, as amended.
McAndrew
Employment Agreement
On
February 12, 2025, we entered into an employment agreement with Dr. McAndrew (the “McAndrew Agreement”), setting forth the
terms of his employment as Chief Business Officer. Pursuant to the McAndrew Agreement, Dr. McAndrew is entitled to, among other things,
(i) an annual gross base salary of $330,000 (“Base Salary”) and (ii) eligibility for a performance-based cash bonus of up
to 35% of the Base Salary, as determined by the Board. The McAndrew Agreement shall terminate in accordance with the terms set forth
therein. Pursuant to the McAndrew Agreement, if Dr. McAndrew is terminated without “Cause” or for “Good Reason”
within 2 months prior to or within 12 months following a “Change in Control”, he is entitled to (i) his base salary for 12
months, (ii) any performance bonus for the performance year in which his termination occurs, and (iii) if he timely continued coverage
under COBRA, payment for COBRA premiums necessary to continue coverage until the earliest of (a) 18 months following the termination
date, (b) the date he becomes eligible for substantially equivalent health insurance coverage in connection with new employment or self-employment,
or (c) the date he becomes ineligible for COBRA continuation coverage. If Dr. McAndrew is terminated without “Cause” or for
“Good Reason” not coincident with a “Change in Control”, he is entitled to (i) his base salary for 9 months,
(ii) any performance bonus for the performance year in which his termination occurs, and (iii) if he timely continued coverage under
COBRA, payment for COBRA premiums necessary to continue coverage until the earliest of (a) 12 months following the termination date,
(b) the date he becomes eligible for substantially equivalent health insurance coverage in connection with new employment or self-employment,
or (c) the date he becomes ineligible for COBRA continuation coverage.
The
foregoing description of the McAndrew Agreement, does not purport to be complete and is qualified in its entirety by reference to the
full text of the McAndrew Agreement, a copy of which is filed herewith as Exhibit 10.6, and is incorporated herein by reference.
b)
None.
c)
During the three months ended December 31, 2024, no director or “officer” (as defined in Rule 16a-1(f) under the Exchange
Act) of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,”
as each term is defined in Item 408(a) of Regulation S-K.
Item
6: Exhibits.
Exhibit
No. |
|
Description |
|
|
|
4.1 |
|
Form of Common Warrant (incorporated by reference to Exhibit 4.22 of the Company’s Registration Statement on Form S-1/A filed with the SEC on November 6, 2024). |
|
|
|
4.2 |
|
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.23 to the Company’s Registration Statement on Form S-1/A filed with the SEC on November 6, 2024). |
|
|
|
4.3 |
|
Form of Registered Direct Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 10, 2024). |
|
|
|
4.4 |
|
Form of Private Placement Pre-Funded Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on December 10, 2024). |
|
|
|
4.5 |
|
Form of Common Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed with the SEC on December 10, 2024). |
|
|
|
10.1 |
|
License Agreement, dated October 8, 2024, between Sonnet BioTherapeutics, Inc., Sonnet BioTherapeutics CH SA and Alkem Laboratories Limited (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on October 9, 2024). |
|
|
|
10.2 |
|
Underwriting Agreement, dated November 6, 2024, between the Company and Chardan Capital Markets, LLC (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 8, 2024). |
|
|
|
10.3 |
|
Form of Registered Direct Securities Purchase Agreement, dated December 9, 2024, by and between the Company and the Purchasers (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on December 10, 2024).
|
|
|
|
10.4 |
|
Form of Private Placement Securities Purchase Agreement, dated December 9, 2024, by and between the Company and the Purchasers (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on December 10, 2024). |
|
|
|
10.5† |
|
Offer Letter, between Donald Griffith and Sonnet BioTherapeutics, Inc., dated January 1, 2019 (incorporated by reference to Exhibit 10.59 to the Company’s Registration Statement on Form S-4 filed with the SEC on February 7, 2020). |
|
|
|
10.6*† |
|
Employment Agreement by and between the Company and Stephen McAndrew, Ph.D., dated February 12, 2025. |
|
|
|
31.1* |
|
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a). |
|
|
|
31.2* |
|
Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a). |
|
|
|
32.1** |
|
Certification of Principal Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.2** |
|
Certification of Chief Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
101.INS* |
|
Inline
XBRL Instance Document - the instance document does not appear in the Interactive Data File
because its XBRL tags are embedded within the Inline XBRL document. |
|
|
|
101.SCH* |
|
Inline
XBRL Taxonomy Extension Schema Document. |
|
|
|
101.CAL* |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
|
|
|
101.DEF* |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document. |
|
|
|
101.LAB* |
|
Inline XBRL Taxonomy Extension Label Linkbase Document. |
|
|
|
101.PRE* |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
|
|
|
104* |
|
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibits 101). |
*
Filed herewith.
**
Furnished, not filed.
† Indicates a
management contract or compensation plan, contract or arrangement.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
SONNET
BIOTHERAPEUTICS HOLDINGS, INC. |
|
|
|
Date:
February 13, 2025 |
By: |
/s/
Pankaj Mohan |
|
|
Pankaj
Mohan |
|
|
President
and Chief Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
|
By: |
/s/
Jay Cross |
|
|
Jay
Cross |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial Officer and Principal Accounting Officer) |
Exhibit
10.6
EXECUTIVE
EMPLOYMENT AGREEMENT
THE
EXECUTIVE EMPLOYMENT AGREEMENT (the “Agreement”), dated as of February 12, 2025 and effective as of the Effective
Date (as defined below) is by and between STEPHEN MCANDREW (the “Executive”) and SONNET BIOTHERAPEUTICS, INC., a New
Jersey corporation (the “Company”).
WHEREAS,
the Executive has been employed as the Company’s SVP of Business Development since on or about 2019;
WHEREAS,
the Executive and the Company agree that as of February 17, 2025 (the “Effective Date”), the Executive will serve as the
Chief Business Officer of the Company; and
WHEREAS,
the Executive agrees to be retained by the Company in such capacity in consideration of such compensation and benefits on the terms and
conditions set forth in this Agreement;
NOW,
THEREFORE, in consideration of the mutual promises and covenants contained in this Agreement, the Company and the Executive agree to
the following:
1.0
Employment by the Company.
1.1
Position. Subject to the terms and conditions set forth in this Agreement, the Company agrees as of the Effective Date, to employ
the Executive in the position of Chief Business Officer, and the Executive hereby accepts such employment on the terms and conditions
set forth in this Agreement. This Agreement shall become effective on the Effective Date.
1.2
Duties. As Chief Business Officer, the Executive will report to the President and Chief Executive Officer of the Company (the
“CEO”), performing such duties that are normally associated with his position and such duties as are assigned to him
from time to time consistent with that position, subject to the oversight and direction of the CEO. During the term of the Executive’s
employment with the Company, the Executive will work on a full-time basis for the Company and will devote his best efforts and substantially
all his business time and attention to the business of the Company. The Executive shall travel on behalf of the Company as may be necessary
or advisable for the best interests of the Company.
1.3
Company Policies and Benefits. The employment relationship between the parties shall also be subject to the Company’s personnel
policies and procedures as they may be interpreted, adopted, revised or deleted from time to time in the Company’s sole discretion.
The Company will provide the Executive and his family with comprehensive health insurance benefits (or reimburse him for purchasing such
insurance) at the Company’s expense. The Company reserves the right to change, alter, or terminate any benefit plan in its sole
discretion. Notwithstanding the foregoing, in the event that the terms of this Agreement differ from or are in conflict with the Company’s
general employment policies or practices, this Agreement shall control Company has a 401(k) planwhich you can participate in. The Executive
shall be eligible to participate in all qualified and non-qualified savings and retirement plans and other compensation benefit plans
and programs made generally available to other employees of the Company.
1.4
Vacation. During the term of this Agreement, the Executive shall receive four (4) weeks of vacation per full calendar
year (prorated for any partial calendar year of employment), subject to the Company’s vacation policies and procedures as in effect
or amended from time to time, which vacation time shall accrue pro-rata on a pay period basis. The Executive may not carryover any earned
but unused vacation time from any calendar year to any subsequent calendar year unless otherwise expressly permitted by applicable Company
policies or the Board.
2.0
Compensation.
2.1
Base Salary. The Company shall compensate the Executive for his services under this Agreement at the annual rate of Three Hundred
Thirty Thousand Dollars ($330,000) (the “Base Salary”), payable in bi-weekly installments, with the pay periods subject
to adjustment by the Company in its sole discretion, and subject to applicable federal and state payroll withholding requirements.
2.2
Performance Bonus. The Company may pay to the Executive a bonus (the “Performance Bonus”) of up to thirty
five percent (35%) of his Base Salary that will be determined based upon performance compared to one or more target metrics established
annually by the Compensation Committee of the Board, or the full Board, in their sole discretion and communicated to the Executive in
writing promptly after such determination. The Performance Bonus will be paid subject to applicable federal and state payroll withholding
requirements. The Executive must be actively employed in good standing on the payment date (typically by March 15 of the subsequent year
to which the Performance Bonus is based) to be eligible to receive a Performance Bonus.
2.3
Stock Options. Company has a stock option plan including RSUs and RSAs, the Board may be awarding at their discretion such awards
on a periodic basis.
2.4
Expense Reimbursement. The Company will reimburse Executive for his reasonable business expenses in accordance with the Company’s
standard expense reimbursement policy, as the same may be modified by the Company from time to time. The reimbursement will apply to
all customary and appropriate business-related expenses actually incurred and documented in accordance with Company policy, as in effect
from time to time. For the avoidance of doubt, to the extent that any reimbursements payable to Executive, are subject to the provisions
of Section 409A of the Internal Revenue Code of 1986, as amended (the “Code”): (a) any such reimbursements will be
paid no later than December 31 of the year following the year in which the expense was incurred, (b) the amount of expenses reimbursed
in one year will not affect the amount eligible for reimbursement in any subsequent year, and (c) the right to reimbursement under this
Agreement will not be subject to liquidation or exchange for another benefit.
3.0
Proprietary Information, Inventions, Non-Competition and Non-Solicitation Obligations. As a condition of employment, the Executive
agrees to execute and abide by an Employee Proprietary Information, Inventions, Non-Competition and Non-Solicitation Agreement attached
as Exhibit A (the “Proprietary Information Agreement”), which may be amended by the parties from time to time
without regard to this Agreement. The Proprietary Information Agreement contains provisions that are intended by the parties to survive
and do survive termination of this Agreement.
4.0
Termination of Employment. The parties acknowledge that the Executive’s employment relationship with the Company is at-will,
meaning either the Company or the Executive may terminate the Executive’s employment at any time, with or without cause or advance
notice. The provisions in this Section 4.0 govern the amount of compensation, if any, to be provided to the Executive upon termination
of employment and do not alter his at-will status.
4.1
Termination by the Company without Cause or termination by the Executive for Good Reason.
a.
The Company shall have the right to terminate Executive’s employment with the Company pursuant to this Section 4.1 at any time,
in accordance with Section 4.6, without “Cause” (as defined in Section 4.3(b) below) by giving notice as described in Section
5.1 of this Agreement. A termination pursuant to Section 4.5 below is not a termination without “Cause” for purposes of receiving
the benefits described in Sections 4.1 or Section 4.2.
b.
In the event that the Company terminates Executive’s employment at any time without Cause or Executive terminates his employment
with the Company for Good Reason and provided that such termination constitutes a “separation from service” (as defined under
Treasury Regulation Section l.409A-1(h), without regard to any alternative definition thereunder (a “Separation from Service”),
then the Executive shall be entitled to receive the Accrued Obligations (defined below). If the Executive complies with the obligations
in Section 4.1 (c) below with respect to timely signing and not revoking his acceptance of a Release, the Executive shall also be eligible
to receive the following “Severance Benefits”:
i.
The Company will pay Executive an amount equal to Executive’s then current Base Salary for nine (9) months, less all applicable
withholdings and deductions, paid in equal installments on the Company’s normal payroll schedule following the termination date,
with the first payment beginning on the Severance Pay Commencement Date (as defined in Section 4.l(c) below), and the remaining installments
occurring on the Company’s regularly scheduled payroll dates thereafter; provided that on the Severance Pay Commencement Date,
the Company will pay in a lump sum the aggregate amount of the cash severance payments that the Company would have paid Executive through
such date had the payments commenced on the effective date of termination through the Severance Pay Commencement Date.
ii.
The Company will pay any performance bonus if awarded by the Board for the performance year in which Executive’s termination occurs.
This bonus will be payable subject to standard federal and state payroll withholding requirements in a lump sum payment on the Severance
Pay Commencement Date.
iii.
If the Executive is enrolled in the Company’s health insurance plan at the time of a Separation of Service and timely elects continued
coverage under COBRA for himself and his covered dependents under the Company’s group health plans following such termination,
then the Company shall pay the COBRA premiums necessary to continue Executive’s and his covered dependents’ health insurance
coverage in effect for himself (and his covered dependents) on the termination date until the earliest of: (i) nine (9) months following
the termination date (the “COBRA Severance Period’’); (ii) the date when Executive becomes eligible for substantially
equivalent health insurance coverage in connection with new employment or self-employment; or (iii) the date Executive ceases to be eligible
for COBRA continuation coverage for any reason, including plan termination (such period from the termination date through the earlier
of (i)-(iii), (the “COBRA Payment Period”). Notwithstanding the foregoing, if at any time the Company determines that
its payment of COBRA premiums on Executive’s behalf would result in a violation of applicable law (including, but not limited to,
the 2010 Patient Protection and Affordable Care Act, as amended by the 2010 Health Care and Education Reconciliation Act), then in lieu
of paying COBRA premiums pursuant to this Section, the Company shall pay Executive on the last day of each remaining month of the COBRA
Payment Period, a fully taxable cash payment equal to the COBRA premium for such month, subject to applicable tax withholding (such amount,
the “Special Severance Payment”), for the remainder of the COBRA Payment Period. Nothing in this Agreement shall deprive
Executive of his rights under COBRA or ERISA for benefits under plans and policies arising under his employment by the Company.
c.
The Executive will be paid all the Accrued Obligations on the Company’s first payroll date after the Executive’s date of
termination from employment or earlier if required by law. The Executive shall receive the Severance Benefits pursuant to Section 4.l
(b) or the Change in Control Severance Benefits (defined below) pursuant to 4.2 (a) of this Agreement, as applicable, if: (i) the Executive
executes and does not revoke a separation agreement containing an effective, general release of claims in favor of the Company and its
affiliates and representatives, in a form acceptable to the Company (the “Release”) and the Release is enforceable
and effective as provided in the Release on or before the date that is the sixtieth (60th) day following the effective date
of termination (such 60th day, the “Severance Pay Commencement Date”); (ii) he holds any other positions
with the Company, he resigns such position(s) to be effective no later than the date of Executive’s termination date (or such other
date as requested by the Board); (iii) he returns all Company property; (iv) he complies with his post-termination obligations under
this Agreement and the Proprietary Information Agreement; and (v) he complies with the terms of the Release, including without limitation
any non-disparagement and confidentiality provisions contained in Release.
d.
For purposes of this Agreement, “Accrued Obligations” are (i) the Executive’s accrued but unpaid Base Salary
through the date of termination, including unused, accrued vacation time; (ii) any unreimbursed business expenses incurred by Executive
payable in accordance with the Company’s standard expense reimbursement policies, and (iii) benefits owed to Executive under any
qualified retirement plan or health and welfare benefit plan in which Executive was a participant in accordance with applicable law and
the provisions of such plan.
e.
The Severance Benefits provided to Executive pursuant to this Section 4.1 are in lieu of, and not in addition to, any benefits to which
Executive may otherwise be entitled under any Company severance plan, policy or program.
f.
Any damages caused by the termination of Executive’s employment without Cause would be difficult to ascertain; therefore, the Severance
Benefits for which Executive is eligible pursuant to Section 4.l (b) above in exchange for the Release is agreed to by the parties as
liquidated damages, to serve as full compensation, and not a penalty.
g.
For purposes of this Agreement, “Good Reason” shall mean the occurrence of any of the following events without Executive’s
written consent: (i) any reduction of twenty-five percent (25%) or more in the Executive’s Base Salary (other than a corresponding
reduction in base salary for other similarly situated employees); (ii) a material breach of this Agreement by the Company; (iii) a material
reduction in the Executive’s duties, authority and responsibilities relative to the Executive’s duties, authority, and responsibilities
in effect immediately prior to such reduction; or (iv) the relocation of Executive’s principal place of employment, without Executive’s
consent, in a manner that lengthens his one-way commute distance by twenty-five (25) or more miles from his then-current principal place
of employment immediately prior to such relocation; provided, however, that, any such termination by Executive shall only be deemed for
Good Reason pursuant to this definition if: (1) Executive gives the Company written notice of his intent to terminate for Good Reason
within thirty (30) days following the first occurrence of the condition(s) that he believes constitute(s) Good Reason, which notice shall
describe such condition(s); (2) the Company fails to remedy such condition(s) within thirty (30) days following receipt of the written
notice (the “Cure Period”); and (3) Executive voluntarily terminates his employment within thirty (30) days following
the end of the Cure Period.
4.2
Termination by the Company without Cause or by Executive for Good Reason Coincident with a Change in Control.
a.
If Executive’s employment by the Company is terminated by the Company or any successor entity without “Cause”
(and not due to Disability or death) or by Executive for Good Reason within two (2) months prior to or within twelve (12) months following
the effective date of a “Change in Control” (as defined in the Company’s Equity Incentive Plan, as such plan
may be amended from time to time), provided that such termination constitutes a Separation from Service, without regard to any alternative
definition thereunder, then in addition to paying or providing Executive with the Accrued Obligations and subject to compliance with
Section 4.l (c), the Company will provide the following “Change in Control Severance Benefits”:
i.
The Company will pay Executive an amount equal to Executive ‘s then current Base Salary for twelve (12) months, less all applicable
withholdings and deductions, paid in equal installments on the Company’s normal payroll schedule following the date of Separation
from Service, with the first payment beginning on the Severance Pay Commencement Date, and the remaining installments occurring on the
Company’s regularly scheduled payroll dates thereafter; provided that on the Severance Pay Commencement Date, the Company will
pay in a lump sum the aggregate amount of the cash severance payments that the Company would have paid Executive through such date had
the payments commenced on the effective date of termination through the Severance Pay Commencement Date.
ii.
The Company will pay performance bonus for the performance year in which Executive’s termination occurs. This bonus will be payable
subject to standard federal and state payroll withholding requirements in a lump sum payment on the Severance Pay Commencement Date.
iii.
If the Executive is enrolled in the Company’s health insurance plan at the time of a Separation of Service and timely elects continued
coverage under COBRA for himself and his covered dependents under the Company’s group health plans following such termination,
then the Company shall pay the COBRA premiums necessary to continue Executive’s and his covered dependents’ health insurance
coverage in effect for himself (and his covered dependents) on the termination date until the earliest of: (i) eighteen (18) months following
the termination date (the “COBRA Severance Period”); (ii) the date when Executive becomes eligible for substantially equivalent
health insurance coverage in connection with new employment or self-employment; or (iii) the date Executive ceases to be eligible for
COBRA continuation coverage for any reason, including plan termination (such period from the termination date through the earlier of
(i)-(iii), (the “COBRA Payment Period”). Notwithstanding the foregoing, if at any time the Company determines that
its payment of COBRA premiums on the Executive’s behalf would result in a violation of applicable law (including, but not limited
to, the 2010 Patient Protection and Affordable Care Act, as amended by the 2010 Health Care and Education Reconciliation Act), then in
lieu of paying COBRA premiums pursuant to this Section, the Company shall pay Executive on the last day of each remaining month of the
COBRA Payment Period, a fully taxable cash payment equal to the COBRA premium for such month, subject to applicable tax withholding (such
amount, the Special Severance Payment”), for the remainder of the COBRA Payment Period. Nothing in the Agreement shall deprive
Executive of his rights under COBRA or ERISA for benefits under plans and policies arising under his employment by the Company.
iv.
Notwithstanding the terms of any equity plan or award agreement to the contrary, the time-based vesting conditions applicable to all
of Executive’s outstanding stock options and/or other equity awards subject to time-based vesting requirements as of Executive
‘s termination date shall vest as follows: (A) if such termination occurs within two (2) months prior to or on the effective date
of a Change in Control, the time-based vesting shall accelerate and be deemed to be satisfied as of the date of Executive’s termination,
and (B) if such termination occurs within twelve (12) months following the effective date of a Change in Control, in the event any surviving
corporation or acquiring corporation assumes Executive’s stock options and/or other equity awards, as applicable, or substitutes
similar stock options or equity awards for Executive’s stock options and/or equity awards, as applicable, in accordance with the
terms of the Company’s equity incentive plans, the time-based vesting of all of such stock options and/or equity awards (or any
substitute stock options or equity awards), as applicable, shall be accelerated in full as of the date of termination. For the avoidance
of doubt, the accelerated vesting provided under this Section 4.2(a)(iii) shall not apply to any liquidity event or performance-based
vesting conditions applicable to any of Executive’s outstanding stock options and/or other equity awards as of the date of termination.
b.
The Change in Control Severance Benefits provided to Executive pursuant to this Section 4.2 are in lieu of, and not in addition to, any
benefits to which Executive may otherwise be entitled under any Company severance plan, policy or program, including but not limited
to the Severance Benefits described in Section 4.l(b). For the avoidance of doubt, in no event shall Executive be entitled to benefits
under both Section 4.l(b) and this Section 4.2. If Executive is eligible for benefits under both Section 4.1(b) and this Section 4.2,
or if Executive begins receiving benefits under Section 4.1(b) and later becomes eligible for benefits under Section 4.2, Executive shall
receive the benefits set forth in this Section 4.2 and such benefits will be reduced by any benefits previously provided to Executive
under Section 4.1(b).
c.
Any damages caused by the termination of the Executive’s employment without Cause or for Good Reason following a Change in Control
would be difficult to ascertain; therefore, the Change in Control Severance Benefits for which Executive is eligible pursuant to Section
4.2(a) above in exchange for the Release is agreed to by the parties as liquidated damages, to serve as full compensation, and not as
a penalty.
4.3
Termination by the Company for Cause.
a.
The Company shall have the right to terminate Executive’s employment with the Company at any time, in accordance with Section 4.6,
for Cause by giving notice as described in Section 5.1 of this Agreement. In the event Executive’s employment is terminated at
any time for Cause, Executive will not receive Severance Benefits, Change in Control Severance Benefits, or any other severance compensation
or benefits, except that, pursuant to the Company’s standard payroll policies, the Company shall pay to Executive the Accrued Obligations.
b.
“Cause” for termination shall mean that the Company has determined in its sole discretion that Executive has engaged
in any of the following: (i) a material breach of any covenant or condition under this Agreement or any other agreement between the parties
; (ii) any act constituting dishonesty, fraud, immoral or disreputable conduct; (iii) any conduct which constitutes a felony under applicable
law; (iv) material violation of any Company policy or any act of misconduct; (v) refusal to follow or implement a clear and reasonable
directive of Company; (vi) negligence or incompetence in the performance of Executive’s duties or failure to perform such duties
in a manner satisfactory to the Company after the expiration of thirty(30) days without cure after written notice of such failure (to
the extent curable); or (vii) breach of fiduciary duty.
4.4
Resignation by Executive.
a.
Executive may resign from Executive’s employment with the Company at any time, in accordance with Section 4.6, by giving notice
as described in Section 5.1.
b.
In the event Executive resigns from Executive’s employment with the Company for any reason other than Good Reason in accordance
with Sections 4.1 or 4.2, Executive will not receive Severance Benefits, Change in Control Severance Benefits, or any other severance
compensation or benefits, except that, pursuant to the Company’s standard payroll policies, the Company shall pay to Executive
the Accrued Obligations.
4.5
Termination by Virtue of Death or Disability of Executive.
a.
In the event of Executive’s death while employed pursuant to this Agreement, all obligations of the parties hereunder shall terminate
immediately, in accordance with Section 4.6, and the Company shall, pursuant to the Company’s standard payroll policies, pay to
Executive’s legal representatives all Accrued Obligations.
b.
Subject to applicable state and federal law, the Company shall at all times have the right, upon written notice to Executive, and in
accordance with Section 4.6, to terminate this Agreement based on Executive’s Disability. Termination by the Company of Executive’s
employment based on “Disability” shall mean termination because Executive is unable due to a physical or mental condition
to perform the essential functions of his position with or without reasonable accommodation for 180 days in the aggregate during any
twelve (12) month period or based on the written certification by two licensed physicians of the likely continuation of such condition
for such period. This definition shall be interpreted and applied consistent with the Americans with Disabilities Act, the Family and
Medical Leave Act, and other applicable law. In the event Executive’s employment is terminated based on Executive’s Disability,
Executive will not receive Severance Benefits, Change in Control Severance Benefits, or any other severance compensation or benefit,
except that, pursuant to the Company’s standard payroll policies, the Company shall pay to Executive the Accrued Obligations.
4.6
Notice; Effective Date of Termination.
a.
Termination of Executive’s employment pursuant to this Agreement shall be effective on the earliest of:
i.
immediately after the Company gives notice to Executive of Executive’s termination, with or without Cause;
ii.
immediately upon the Executive’s death or Disability;
iii.
thirty (30) days after the Executive gives written notice to the Company of Executive’s resignation, provided that the Company
may set a termination date at any time between the date of notice and the date of resignation (in which case the Company’s obligation
to provide continued compensation shall cease); or
iv.
for a termination for Good Reason, immediately upon the Executive’s full satisfaction of the requirements of Section 4.l(g).
b.
In the event notice of a termination under subsections (a)(i) or (iii) is given orally, at the other party’s request, the party
giving notice must provide written confirmation of such notice within five (5) business days of the request in compliance with the requirement
of Section 5.1 below. In the event of a termination for Cause, written confirmation shall specify the subsection(s) of the definition
of Cause relied on to support the decision to terminate.
4.7
Cooperation with Company after Termination of Employment.
During
the term of employment as well as following termination of the Executive’s employment for any reason, the Executive agrees to cooperate
fully with the Company in connection with its actual or contemplated defense, prosecution, or investigation of any claims or demands
by or against third parties, or other matters arising from events, acts, or failures to act that occurred during the period of Executive’s
employment by the Company. Such cooperation includes, without limitation, making Executive available to the Company upon reasonable notice,
without subpoena, to provide complete, truthful and accurate information in witness interviews, depositions and trial testimony. In addition,
for twelve (12) months after Executive’s employment with the Company ends for any reason, Executive agrees to reasonably cooperate
fully with the Company in all matters relating to the transition of Executive’s work and responsibilities on behalf of the Company,
including, but not limited to, any present, prior or subsequent relationships and the orderly transfer of any such work and institutional
knowledge to such other persons as may be designated by the Company. Subject to the Executive providing advance written notice for the
request and sufficient detail to support the expenses, the Company will reimburse Executive for reasonable out-of-pocket expenses Executive
incurs in connection with any such cooperation (excluding forgone wages, salary, or other compensation but including reasonable travel,
lodging, meal expenses and legal fees and in addition, the Executive shall be entitled to a per diem amount for his services equal to
his most recent annualized Base Salary under this Agreement, and will make reasonable efforts to accommodate Executive’s scheduling
needs.
4.8
Application of Section 409A.
It
is intended that all of the severance payments payable under this Agreement satisfy, to the greatest extent possible, the exemptions
from the application of Section 409A of the Code and the regulations and other guidance thereunder and any state law of similar effect
(collectively, “Section 409A”) provided under Treasury Regulations Sections l.409A-l (b)(4) and l.409A- l(b)(9), and
this Agreement will be construed in a manner that complies with Section 409A. If not so exempt, this Agreement (and any definitions hereunder)
will be construed in a manner that complies with Section 409A and incorporates by reference all required definitions and payment terms.
No severance payments will be made under this Agreement unless the Executive’s termination of employment constitutes a “separation
from service” (as defined under Treasury Regulation Section l .409A-1(h)). For purposes of Section 409A (including, without limitation,
for purposes of Treasury Regulations Section 1.409A-2(b)(2)(iii)), Executive’s right to receive any installment payments under
this Agreement (whether severance payments or otherwise) shall be treated as a right to receive a series of separate payments and, accordingly,
each installment payment hereunder shall at all times be considered a separate and distinct payment. If the Company determines that the
severance benefits provided under this Agreement constitutes “deferred compensation” under Section 409A and if Executive
is a “specified employee” of the Company, as such term is defined in Section 409A(a)(2)(B)(i) of the Code at the time of
Executive’s Separation from Service, then, solely to the extent necessary to avoid the incurrence of the adverse personal tax consequences
under Section 409A, the timing of the Severance will be delayed as follows: on the earlier to occur of (a) the date that is six months
and one day after Executive’s Separation from Service, and (b) the date of Executive’s death (such earlier date, the “Delayed
Initial Payment Date”), the Company will (i) pay to Executive a lump sum amount equal to the sum of the severance benefits
that Executive would otherwise have received through the Delayed Initial Payment Date if the commencement of the payment of the severance
benefits had not been delayed pursuant to this Section 6.8 and (ii) commence paying the balance of the severance benefits in accordance
with the applicable payment schedule set forth in Section 6. No interest shall be due on any amounts deferred pursuant to this Section
6.8. To the extent that any Severance Benefits are deferred compensation under Section 409A of the Code and are not otherwise exempt
from the application of Section 409A, then, if the period during which Executive may consider and sign the Release spans two calendar
years, the payment of any such Severance Benefit will not be made or begin until the later calendar year.
4.9
Indemnification.
The
Company shall indemnify Executive, to the maximum extent permitted by applicable law, against all costs, charges and expenses incurred
or sustained by Executive in connection with any action, suit or proceeding (or threatened action, suit or proceeding) to which Executive
might be a party by reason of being an officer, Director, or employee of the Company or of any subsidiary or Affiliate of the Company.
The Company shall provide, at its expense, Directors and Officers insurance for Executive in amounts reasonably satisfactory to Executive,
to the extent such insurance is available at reasonable rates, which determination shall be made by the Board of Directors. (“Affiliate”)
shall mean and include any person, corporation or other entity controlling, controlled by or under common control with the corporation
in question.
4.10
Section 280G.
Notwithstanding
any other provision of this Agreement to the contrary, if payments made or benefits provided pursuant to this Agreement or otherwise
from the Company or any person or entity are considered “parachute payments” under Section 280G of the Code, then such parachute
payments will be limited to the greatest amount that may be paid to Executive under Section 280G of the Code without causing any loss
of deduction to the Company Group under such section, but only if, by reason of such reduction, the net after tax benefit to Executive
will exceed the net after tax benefit if such reduction were not made. “Net after tax benefit” for purposes of this
Agreement will mean the sum of (i) the total amounts payable to the Executive under this Agreement , plus (ii) all other payments and
benefits which the Executive receives or then is entitled to receive from the Company or otherwise that would constitute a “parachute
payment” within the meaning of Section 280G of the Code, less (iii) the amount of federal and state income taxes payable with respect
to the foregoing calculated at the maximum marginal income tax rate for each year in which the foregoing will be paid to Executive (based
upon the rate in effect for such year as set forth in the Code at the time of termination of Executive’s employment), less (iv)
the amount of excise taxes imposed with respect to the payments and benefits described in (i) and (ii) above by Section 4999 of the Code.
The determination as to whether and to what extent payments are required to be reduced in accordance with this Section 6.9 will be made
at the Company’s expense by a nationally recognized certified public accounting firm as may be designated by the Company prior
to a change in control (the “Accounting Firm”). In the event of any mistaken underpayment or overpayment under this
Agreement, as determined by the Accounting Firm, the amount of such underpayment or overpayment will forthwith be paid to Executive or
refunded to the Company, as the case may be. Any reduction in payments required by this Section 6.9 will occur in the following order:
(1) any cash severance, (2) any other cash amount payable to Executive, (3) any employee benefit or perquisite valued as a “parachute
payment,” (4) the acceleration of vesting of any equity awards that are options, and (5) the acceleration of vesting of any other
equity awards. Within any such category of payments and benefits, a reduction will occur first with respect to amounts that are not “deferred
compensation” within the meaning of Section 409A and then with respect to amounts that are. In the event that acceleration of compensation
from equity awards is to be reduced, such acceleration of vesting will be canceled, subject to the immediately preceding sentence, in
the reverse order of the date of grant.
5.0
General Provisions.
5.1
Notices. Any notices required or permitted under this Agreement to be in writing shall be deemed effectively given: (a) upon
personal delivery to the party to be notified, (b) when sent by electronic mail or confirmed facsimile if sent during normal business
hours of the recipient, and if not, then on the next business day, (c) five (5) days after having been sent by registered or certified
mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationally recognized overnight courier, specifying
next day delivery, with written verification of receipt. All communications shall be sent to the Company at its primary office location
and to the Executive at either the Executive’s address as listed on the Company’s payroll records, or the Executive’s
Company-issued email address, or at such other address as the Company or Executive may designate by ten (I0) days advance written notice
to the other.
5.2
Severability. Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid
under applicable law, but if any provision of this Agreement is held to be invalid, illegal or unenforceable in any respect under any
applicable law or rule in any jurisdiction, such invalidity, illegality or unenforceability will not affect any other provision or any
other jurisdiction. In such event, this Agreement will be reformed, construed and enforced in such jurisdiction as if such invalid, illegal
or unenforceable provisions had never been contained in this Agreement.
5.3
Survival. Provisions of this Agreement that by their terms must survive the termination of this Agreement in order to effectuate
the intent of the parties will survive any such termination for such period as may be appropriate under the circumstances.
5.4
Waiver. If either party should waive any breach of any provisions of this Agreement, it shall not thereby be deemed to have waived
any preceding or succeeding breach of the same or any other provision of this Agreement.
5.5
Complete Agreement. This Agreement constitutes the entire agreement between Executive and the Company with regard to the subject
matter hereof. This Agreement is the complete, final, and exclusive embodiment of their agreement with regard to this subject matter
and supersedes any prior oral discussions or written communications and agreements, including any prior employment agreement between
the parties. This Agreement is entered into without reliance on any promise or representation other than those expressly contained herein,
and it cannot be modified or amended except in writing signed by Executive and an authorized officer of the Company. The parties have
entered into a separate Proprietary Information Agreement and have or may enter into separate agreements related to the stock options.
These separate agreements govern other aspects of the relationship between the parties, have or may have provisions that survive termination
of Executive’s employment under this Agreement, may be amended or superseded by the parties without regard to this Agreement and
are enforceable according to their terms without regard to the enforcement provision of this Agreement.
5.6
Counterparts. This Agreement may be executed in separate counterparts, any one of which need not contain signatures of more than
one party, but all of which taken together will constitute one and the same Agreement. The parties agree that facsimile and scanned image
copies of signatures will suffice as original signatures.
5.7
Withholding Taxes. The Company will be entitled to withhold from any payment due to Executive under this Agreement any amounts
required to be withheld by applicable tax laws or regulations.
5.8
Headings. The headings of the sections hereof are inserted for convenience only and shall not be deemed to constitute a part
hereof nor to affect the meaning thereof.
5.9
Successors and Assigns. The Company shall assign this Agreement and its rights and obligations hereunder in whole, but not in
part, to any company or other entity with or into which the Company may hereafter merge or consolidate or to which the Company may transfer
all or substantially all of its assets, if in any such case said Company or other entity shall by operation of law or expressly in writing
assume all obligations of the Company hereunder as fully as if it had been originally made a party hereto, but may not otherwise assign
this Agreement or its rights and obligations hereunder. The Executive may not assign or transfer this Agreement or any rights or obligations
hereunder, other than to his estate upon his death.
5.10
Choice of Law. All questions concerning the construction, validity and interpretation of this Agreement will be governed by the
laws of the State of New Jersey.
5.11
Dispute Resolution. This section shall be interpreted in accordance with the Federal Arbitration Act. The parties recognize that
litigation in federal or state courts or before federal or state administrative agencies of disputes arising out of the Executive’s
employment with the Company or out of this Agreement, or the Executive’s termination of employment or termination of this Agreement,
may not be in the best interests of either the Executive or the Company, and may result in unnecessary costs, delays, complexities, and
uncertainty. The parties agree that any dispute between the parties arising out of or relating to the negotiation, execution, performance
or termination of this Agreement or the Executive’s employment, including, but not limited to, any claim arising out of this Agreement,
claims under Title VII of the Civil Rights Act of 1964, as amended, the Civil Rights Act of 1991, the Age Discrimination in Employment
Act of 1967, the Americans with Disabilities Act of 1990, Section 1981 of the Civil Rights Act of 1966, as amended, the Family Medical
Leave Act, the Executive Retirement Income Security Act, and any similar federal, state or local law, statute, regulation, or any common
law doctrine, whether that dispute arises during or after employment, shall be settled by binding arbitration in accordance with the
National Rules for the Resolution of Employment Disputes of the American Arbitration Association; provided however, that this dispute
resolution provision shall not apply to any separate agreements between the parties that do not themselves specify arbitration as an
exclusive remedy. The location for the arbitration shall be the Princeton, New Jersey area. Any award made by such panel shall be final,
binding and conclusive on the parties for all purposes, and judgment upon the award rendered by the arbitrators may be entered in any
court having jurisdiction thereof. The arbitrators’ fees and expenses and all administrative fees and expenses associated with
the filing of the arbitration shall be borne by the Company; provided however, that at the Executive’s option, the Executive may
voluntarily pay up to one-half the costs and fees. The parties acknowledge and agree that their obligations to arbitrate under this Section
survive the termination of this Agreement and continue after the termination of the employment relationship between Executive and the
Company. The parties each further agree that the arbitration provisions of this Agreement shall provide each party with its exclusive
remedy, and each party expressly waives any right it might have to seek redress in any other forum, except as otherwise expressly provided
in this Agreement. By electing arbitration as the means for final settlement of all claims, the parties hereby waive their respective
rights to, and agree not to, sue each other in any action in a Federal, State or local court with respect to such claims, but may seek
to enforce in court an arbitration award rendered pursuant to this Agreement. The parties specifically agree to waive their respective
rights to a trial by jury, and further agree that no demand, request or motion will be made for trial by jury.
[SIGNATURES
TO FOLLOW ON NEXT PAGE]
IN
WITNESS WHEREOF, the parties have duly executed this Agreement as of the date first above written.
|
SONNET
BIOTHERAPEUTICS, INC. |
|
|
|
|
By: |
/s/
Pankaj Mohan, Ph.D. |
|
Name: |
Pankaj
Mohan, Ph.D. |
|
Title:
|
President
& Chief Executive Officer |
|
EXECUTIVE: |
|
|
|
/s/
Stephen McAndrew |
|
Stephen
McAndrew |
Exhibit
31.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Pankaj Mohan certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q of Sonnet BioTherapeutics Holdings, Inc. (the “Registrant”) for the period
ended December 31, 2024;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this
report;
4.
The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
a.
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b.
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c.
evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d.
disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s
most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
5.
The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing
the equivalent functions):
a.
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information;
and
b.
any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s
internal control over financial reporting.
Date:
February 13, 2025 |
|
|
/s/
Pankaj Mohan |
|
Pankaj
Mohan |
|
President
and Chief Executive Officer |
|
(Principal
Executive Officer) |
Exhibit
31.2
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER
PURSUANT
TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Jay Cross certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q of Sonnet BioTherapeutics Holdings, Inc. (the “Registrant”) for the period
ended December 31, 2024;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this
report;
4.
The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:
a.
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b.
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c.
evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
d.
disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s
most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
5.
The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing
the equivalent functions):
a.
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information;
and
b.
any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s
internal control over financial reporting.
Date:
February 13, 2025 |
|
|
/s/
Jay Cross |
|
Jay
Cross |
|
Chief
Financial Officer |
|
(Principal
Financial and Accounting Officer) |
Exhibit
32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Sonnet BioTherapeutics Holdings, Inc. (the “Company”) on Form 10-Q for the quarter
ended December 31, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Pankaj
Mohan, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1) |
The
Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as
amended; and |
|
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Date:
February 13, 2025
/s/
Pankaj Mohan |
|
Pankaj
Mohan |
|
President
and Chief Executive Officer |
|
(Principal
Executive Officer) |
|
The
foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or
as a separate disclosure document.
Exhibit
32.2
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Sonnet BioTherapeutics Holdings, Inc. (the “Company”) on Form 10-Q for the quarter
ended December 31, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Jay Cross,
Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002, that, to my knowledge:
(1) |
The
Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as
amended; and |
|
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Date:
February 13, 2025
/s/
Jay Cross |
|
Jay
Cross |
|
Chief
Financial Officer |
|
(Principal
Financial and Accounting Officer) |
|
The
foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or
as a separate disclosure document.
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Entity File Number |
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Entity Registrant Name |
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BIOTHERAPEUTICS HOLDINGS, INC.
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v3.25.0.1
Consolidated Balance Sheets (Unaudited) - USD ($)
|
Dec. 31, 2024 |
Sep. 30, 2024 |
Current assets: |
|
|
Cash |
$ 4,861,503
|
$ 149,456
|
Unbilled collaboration revenue |
500,000
|
|
Prepaid expenses and other current assets |
1,196,868
|
1,206,409
|
Incentive tax receivable |
166,792
|
762,078
|
Total current assets |
6,725,163
|
2,117,943
|
Property and equipment, net |
17,312
|
20,523
|
Operating lease right-of-use asset |
104,435
|
123,417
|
Deferred offering costs |
122,058
|
15,000
|
Other assets |
213,059
|
494,147
|
Total assets |
7,182,027
|
2,771,030
|
Current liabilities: |
|
|
Accounts payable |
1,639,981
|
2,183,416
|
Accrued expenses and other current liabilities |
1,394,520
|
942,489
|
Current portion of operating lease liability |
87,323
|
84,291
|
Total current liabilities |
3,121,824
|
3,210,196
|
Operating lease liability, net of current portion |
23,634
|
46,573
|
Total liabilities |
3,145,458
|
3,256,769
|
Commitments and contingencies (Note 4) |
|
|
Stockholders’ equity (deficit): |
|
|
Preferred stock, $0.0001 par value: 5,000,000 shares authorized; no shares issued or outstanding |
|
|
Common stock, $0.0001 par value: 125,000,000 shares authorized; 3,007,431 and 650,284 issued and outstanding at December 31, 2024 and September 30, 2024, respectively |
300
|
65
|
Additional paid-in capital |
124,877,960
|
117,195,181
|
Accumulated deficit |
(120,841,691)
|
(117,680,985)
|
Total stockholders’ equity (deficit) |
4,036,569
|
(485,739)
|
Total liabilities and stockholders’ equity (deficit) |
$ 7,182,027
|
$ 2,771,030
|
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v3.25.0.1
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Dec. 31, 2024 |
Sep. 30, 2024 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
5,000,000
|
5,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
125,000,000
|
125,000,000
|
Common stock, shares issued |
3,007,431
|
650,284
|
Common stock, shares outstanding |
3,007,431
|
650,284
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.25.0.1
Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
Dec. 31, 2024 |
Dec. 31, 2023 |
Income Statement [Abstract] |
|
|
Collaboration revenue |
$ 1,000,000
|
$ 18,626
|
Operating expenses: |
|
|
Research and development |
1,886,076
|
644,042
|
General and administrative |
1,963,346
|
653,455
|
Total operating expenses |
3,849,422
|
1,297,497
|
Loss from operations |
(2,849,422)
|
(1,278,871)
|
Foreign exchange (loss) gain |
(152,884)
|
110,362
|
Loss before provision from income taxes |
(3,002,306)
|
(1,168,509)
|
Provision for income taxes |
(158,400)
|
|
Net loss |
$ (3,160,706)
|
$ (1,168,509)
|
Per share information: |
|
|
Net loss per share, basic |
$ (1.56)
|
$ (2.46)
|
Net loss per share, diluted |
$ (1.56)
|
$ (2.46)
|
Weighted average shares outstanding, basic |
2,022,818
|
474,699
|
Weighted average shares outstanding, diluted |
2,022,818
|
474,699
|
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v3.25.0.1
Consolidated Statements of Changes in Stockholders' Equity (Deficit) (unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Sep. 30, 2023 |
$ 22
|
$ 110,017,751
|
$ (110,243,753)
|
$ (225,980)
|
Balance, shares at Sep. 30, 2023 |
218,786
|
|
|
|
Sale of common stock, net of issuance costs |
$ 16
|
3,916,927
|
|
3,916,943
|
Sale of common stock, net of issuance costs, shares |
163,281
|
|
|
|
Retirement of shares in connection with reverse stock split |
|
|
|
|
Retirement of shares in connection with reverse stock split, shares |
(190)
|
|
|
|
Net share settlement of warrants |
|
|
|
|
Net share settlement of warrants, shares |
1,795
|
|
|
|
Share-based compensation |
|
50,005
|
|
50,005
|
Net loss |
|
|
(1,168,509)
|
(1,168,509)
|
Balance at Dec. 31, 2023 |
$ 38
|
113,984,683
|
(111,412,262)
|
2,572,459
|
Balance, shares at Dec. 31, 2023 |
383,672
|
|
|
|
Balance at Sep. 30, 2024 |
$ 65
|
117,195,181
|
(117,680,985)
|
(485,739)
|
Balance, shares at Sep. 30, 2024 |
650,284
|
|
|
|
Sale of common stock, net of issuance costs |
$ 105
|
7,622,514
|
|
7,622,619
|
Sale of common stock, net of issuance costs, shares |
1,050,500
|
|
|
|
Retirement of shares in connection with reverse stock split |
|
|
|
|
Retirement of shares in connection with reverse stock split, shares |
(373)
|
|
|
|
Shares released from abeyance |
$ 3
|
(3)
|
|
|
Shares released from abeyance, shares |
32,375
|
|
|
|
Net share settlement of warrants |
|
|
|
|
Net share settlement of warrants, shares |
1,209
|
|
|
|
Exercise of warrants |
$ 127
|
(127)
|
|
|
Exercise of warrants, shares |
1,273,436
|
|
|
|
Share-based compensation |
|
60,395
|
|
60,395
|
Net loss |
|
|
(3,160,706)
|
(3,160,706)
|
Balance at Dec. 31, 2024 |
$ 300
|
$ 124,877,960
|
$ (120,841,691)
|
$ 4,036,569
|
Balance, shares at Dec. 31, 2024 |
3,007,431
|
|
|
|
X |
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v3.25.0.1
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
Dec. 31, 2024 |
Dec. 31, 2023 |
Cash flows from operating activities: |
|
|
Net loss |
$ (3,160,706)
|
$ (1,168,509)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation |
3,211
|
3,211
|
Acquired in-process research and development |
12,000
|
12,000
|
Amortization of operating lease right-of-use asset |
18,982
|
16,763
|
Share-based compensation |
60,395
|
50,005
|
Changes in operating assets and liabilities: |
|
|
Unbilled collaboration revenue |
(500,000)
|
|
Prepaid expenses and other current assets |
9,541
|
269,116
|
Incentive tax receivable |
595,286
|
592,463
|
Other assets |
281,088
|
(77,656)
|
Accounts payable |
(635,568)
|
(465,735)
|
Accrued expenses and other current liabilities |
425,432
|
(2,287,544)
|
Operating lease liability |
(19,907)
|
(17,225)
|
Deferred income |
|
(18,626)
|
Net cash used in operating activities |
(2,910,246)
|
(3,091,737)
|
Cash flows from financing activities: |
|
|
Proceeds from issuance of common stock, net of issuance costs |
7,711,161
|
3,838,870
|
Payment of deferred offering costs |
(75,000)
|
|
Payment of warrant issuance costs |
(13,868)
|
|
Net cash provided by financing activities |
7,622,293
|
3,838,870
|
Net increase in cash |
4,712,047
|
747,133
|
Cash, beginning of period |
149,456
|
2,274,259
|
Cash, end of period |
4,861,503
|
3,021,392
|
Supplemental disclosure of non-cash operating, investing and financing activities: |
|
|
In-process research and development in accrued expenses |
12,000
|
12,000
|
Deferred offering costs in accounts payable and accrued expenses |
32,058
|
15,000
|
Common stock issuance costs in accounts payable |
$ 88,542
|
|
X |
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v3.25.0.1
Organization and Description of Business
|
3 Months Ended |
Dec. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Description of Business |
1.
Organization and Description of Business
Description
of business
Sonnet
BioTherapeutics, Inc. (“Prior Sonnet”) was incorporated as a New Jersey corporation on April 6, 2015. Prior Sonnet completed
a merger with publicly-held Chanticleer Holdings, Inc. (“Chanticleer”) on April 1, 2020. After the merger, Chanticleer changed
its name to Sonnet BioTherapeutics Holdings, Inc. (“Sonnet” or the “Company”). Sonnet is a clinical stage, oncology-focused
biotechnology company with a proprietary platform for innovating biologic medicines of single or bifunctional action. Known as FHAB™
(Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and “hitch-hikes”
on human serum albumin (“HSA”) for transport to target tissues. Sonnet designed the construct to improve drug accumulation
in solid tumors, as well as to extend the duration of activity in the body. FHAB development candidates can be produced in
mammalian cell culture, which enables glycosylation of the interleukins, thereby reducing the risk of immunogenicity, as well as E. coli.
Sonnet believes its FHAB technology, for which it received a U.S. patent in June 2021, is a distinguishing feature of its
biopharmaceutical platform. The approach is well suited for future drug development across a range of human disease areas, including
in oncology, autoimmune, pathogenic, inflammatory, and hematological conditions.
Sonnet’s
lead proprietary asset, SON-1010, is a fully human version of Interleukin 12 (“IL-12”), covalently linked to the FHAB
construct, for which Sonnet is pursuing clinical development in solid tumor indications, including ovarian cancer, non-small cell lung
cancer and head and neck cancer. In March 2022, the FDA cleared Sonnet’s Investigational New Drug (“IND”) application
for SON-1010. This allowed the Company to initiate a U.S. clinical trial (SB101) in oncology patients with solid tumors during the second
calendar quarter of 2022. In September 2021, the Company created a wholly-owned Australian subsidiary, SonnetBio Pty Ltd (“Subsidiary”),
for the purpose of conducting certain clinical trials. Sonnet received approval and initiated an Australian clinical study (SB102) of
SON-1010 in healthy volunteers during the third calendar quarter of 2022. Interim safety and tolerability data from the SB101 and SB102
studies were reported in April 2023.
In
January 2023, Sonnet announced a collaboration agreement with Roche for the clinical evaluation of SON-1010 with atezolizumab (Tecentriq®).
The companies have entered into a Master Clinical Trial and Supply Agreement (“MCSA”), along with ancillary Quality and Safety
Agreements, to study the safety and efficacy of the combination of SON-1010 and atezolizumab in a platinum-resistant ovarian cancer (“PROC”)
patient setting. Further, the companies will provide SON-1010 and atezolizumab, respectively, for use in the Phase 1b/Phase 2a combination
safety, dose-escalation, and proof-of-concept study (SB221). Part 1 of this 2-part study was approved in June 2023 by the local Human
Research Ethics Committee in Australia under CT-2023-CTN-01399-1 and the Therapeutic Goods Administration has been notified. In August
2023, the FDA accepted the IND for SB221. The trial consists of a modified 3+3 dose-escalation design in Part 1 to establish the maximum
tolerated dose (“MTD”) of SON-1010 with a fixed dose of atezolizumab. Clinical benefit in PROC will be confirmed in an expansion
group to establish the recommended Phase 2 dose (“RP2D”). Part 2 of the study will then investigate SON-1010 in combination
with atezolizumab, or the standard of care (“SOC”) for PROC in a randomized comparison to show proof-of-concept (“POC”).
In
January 2025, Sonnet announced an expansion of its Phase 1 SB101 clinical study of SON-1010 to add a new cohort to evaluate its effect
in combination with trabectedin (Yondelis®), following the successful completion of monotherapy dose escalation. Trabectedin
is an alkylating DNA-binding agent that was approved as a second-line treatment in early 2024 for patients with unresectable, metastatic
liposarcoma or leiomyosarcoma who have received a prior anthracycline-containing regimen. It is also known to activate tumor macrophages
into a pro-inflammatory phenotype. The Company believes that SON-1010 has the potential to complement that activity by activating the
NK and T cells in the TME to secrete more interferon-gamma (IFNγ), which is considered to be important for anti-tumor control.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
Company acquired the global development rights to its most advanced compound, SON-080, a fully human version of Interleukin 6 (“IL-6”),
in April 2020 through its acquisition of the outstanding shares of Relief Therapeutics SA. Sonnet is advancing SON-080 in target indications
of Chemotherapy-Induced Peripheral Neuropathy (“CIPN”) and Diabetic Peripheral Neuropathy (“DPN”). Sonnet received
approval to initiate an ex-U.S. Phase 1b/2a study with SON-080 in CIPN during the third quarter of 2022. The Data Safety Monitoring Board
(“DSMB”) overseeing the study met during the first calendar quarter of 2024 and cleared the trial to proceed to Part 2. Following
the completion of the DSMB review, Sonnet announced initial safety data from the CIPN study. The objective will be to analyze the data
and to consider initiating a Phase 2 study, pending the outcome of any partnering activity. On October 8, 2024, the Company entered into
a License Agreement (the “Alkem Agreement”) with Alkem Laboratories Limited (“Alkem”) to develop and commercialize
SON-080 for DPN in India. Alkem will conduct all clinical trials that it believes appropriate to obtain regulatory approval in India
for SON-080 for the treatment of DPN.
SON-1210
(IL12-FHAB-IL15), Sonnet’s lead bifunctional construct, combines FHAB with single-chain human IL-12 and
human Interleukin 15 (“IL-15”). This compound is being developed for solid tumor indications, including colorectal and
pancreatic cancer. In February 2023, Sonnet announced the successful completion of two IND-enabling toxicology studies with SON-1210
in non-human primates. In August 2024, the Company entered into a Master Clinical Collaboration Agreement (the “SOC
Agreement”) with the Sarcoma Oncology Center (“SOC”) to advance the development of SON-1210. An Innovative Immuno
Oncology Consortium (“IIOC”) that is funded by the SOC will conduct an investigator-initiated Phase 1b/2a study of
SON-1210 in pancreatic cancer. The IIOC submitted a pre-IND package to the FDA. Based on the FDA feedback, preparations for the full
IND submission package are underway.
SON-1411
(IL18-FHAB-IL12) is a bifunctional combination of human Interleukin 18 (“IL-18”), which was modified to resist
interaction with the IL-18 inhibitor binding protein, and single-chain human IL-12 for solid tumor cancers. Cell line development and
process development are ongoing, with early experimental drug supply suitable for formulation and analytical method development activities.
After some delays in 2024, activities will continue through 2025 with the potential to generate a drug suitable for preclinical studies
and subsequent human studies.
Sonnet
has completed sequence confirmation for SON-3015 (anti-IL6-FHAB-anti-TGFβ). Early-stage bifunctional drug has been generated
and is being stored for future use in in vivo mice studies. The Company has elected to place the SON-3015 development program on hold
for expense reduction purposes.
Liquidity
The Company has incurred recurring losses and
negative cash flows from operations since inception and it expects to generate losses from operations for the foreseeable future primarily
due to research and development costs for its potential product candidates. The Company believes its cash at December 31, 2024 of
$4.9 million will fund the Company’s projected operations into July 2025. The Company received preliminary approval of its application to sell up to $0.8 million of its New Jersey state
net operating losses through the Technology Business Tax Certificate Transfer Program (the “Program”), subject to execution
of such sale (see Note 8). Substantial additional financing will be needed by the
Company to fund its operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
The accompanying unaudited interim consolidated financial statements have been prepared on a going concern basis, which contemplates the
realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s
ability to continue as a going concern exists. The unaudited interim consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty.
The Company plans to secure additional capital
in the future through equity or debt financings, including sales pursuant to its ChEF Purchase Agreement (the “Purchase Agreement”)
with Chardan Capital Markets, LLC (“Chardan”), related to a “ChEF,” Chardan’s committed equity facility
(the “Facility”); partnerships; collaborations; or other sources to carry out the Company’s planned development activities.
If additional capital is not available when required, the Company may need to delay or curtail its operations until such funding is received.
Various internal and external factors will affect whether and when the Company’s product candidates become approved for marketing
and successful commercialization. The regulatory approval and market acceptance of the Company’s product candidates, length of time
and cost of developing and commercializing these product candidates and/or failure of them at any stage of the approval process will materially
affect the Company’s financial condition and future operations.
Operations
since inception have consisted primarily of organizing the Company, securing financing, developing technologies through research and
development and conducting preclinical studies. The Company faces risks associated with companies whose products are in development.
These risks include the need for additional financing to complete its research and development, achieving its research and development
objectives, defending its intellectual property rights, recruiting and retaining skilled personnel, and dependence on key members of
management.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
|
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v3.25.0.1
Summary of Significant Accounting Policies
|
3 Months Ended |
Dec. 31, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2.
Summary of Significant Accounting Policies
a. Basis of presentation
The
accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information as found in the Accounting Standards Codification (“ASC”)
and Accounting Standards Updates (ASUs”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management,
the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily
of accruals, estimates and assumptions that impact the unaudited interim consolidated financial statements) considered necessary to present
fairly the Company’s financial position as of December 31, 2024 and its results of operations and cash flows for the three
months ended December 31, 2024 and 2023. The unaudited interim consolidated financial statements presented herein do not contain
all of the required disclosures under U.S. GAAP for annual financial statements and should be read in conjunction with the annual audited
consolidated financial statements and related notes of Sonnet as of and for the year ended September 30, 2024 included in the Company’s
Annual Report on Form 10-K for the fiscal year ended September 30, 2024. The results of operations for the interim periods are not
necessarily indicative of the results of operations to be expected for the full year.
b. Consolidation
The
unaudited interim consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany
accounts and transactions have been eliminated in consolidation.
c. Use of estimates
The
preparation of the unaudited interim consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Significant estimates
and assumptions reflected in these unaudited interim consolidated financial statements include the accrual of research and development
expenses. Estimates and assumptions are periodically reviewed in-light of changes in circumstances, facts and experience. Changes in
estimates are recorded in the period in which they become known. Actual results could differ from management’s estimates.
d. Incentive tax receivable
Subsidiary
is eligible to participate in an Australian research and development tax incentive program. As part of this program, Subsidiary is eligible
to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by Subsidiary
in Australia. The
cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian) during the reimbursable
period. The Company estimates the amount of cash
refund it expects to receive related to the Australian research and development tax incentive program and records the incentive when
it is probable (i) the Company will comply with relevant conditions of the program and (ii) the incentive will be received. As of December 31,
2024, the Company’s estimate of the amount of cash refund it expects to receive for eligible spending related to the Australian
research and development tax incentive program was $0.2
million. For each of the three months ended December 31,
2024 and 2023, $0.2 million for the expected net cash refund related to the tax incentive program was included as a reduction in research
and development expenses. In November 2024, the Company received $0.7
million from the Australian government related
to eligible research and development expenses for the year ended September 30, 2024. In December 2023, the Company received $0.8 million from the Australian government related to eligible research and
development expenses for the year ended September 30, 2023.
e. Property and equipment
Property
and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Expenditures
for repairs and maintenance that do not extend the estimated useful life or improve an asset are expensed as incurred. Upon retirement
or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts, and any
resulting gain or loss is included in the consolidated statement of operations.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
f. Deferred offering costs
Legal
and other costs incurred in relation to equity offerings are capitalized as deferred offering costs and charged against the proceeds
from equity offerings when received. If a financing is abandoned, deferred offering costs are expensed.
g. Derivative liability
The
Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separate
accounting from the underlying agreement. An embedded derivative that requires separation is accounted for as a separate asset or liability
from the host agreement. The derivative asset or liability is accounted for at fair value, with changes in fair value recognized in the
consolidated statement of operations. The Company determined that certain features under the Purchase Agreement (see Note 6) qualified
as embedded derivatives. The derivative liability is accounted for separately from the Purchase Agreement at fair value, which
has been deemed de minimis.
h. Collaboration revenue
Collaboration
arrangements may contain multiple components, which may include (i) licenses; (ii) research and development activities; and (iii) the
manufacturing and supply of certain materials. Payments pursuant to these arrangements may include non-refundable payments, upfront payments,
milestone payments upon the achievement of significant regulatory and development events, sales milestones and royalties on product sales.
The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in
a future period.
In
determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under a collaboration arrangement,
the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of
whether the promised goods or services are performance obligations, including whether they are capable of being distinct; (iii) measurement
of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance
obligations; and (v) recognition of revenue as the Company satisfies each performance obligation.
The
Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations,
allocating transaction price to performance obligations within a contract, determining when performance obligations have been met,
and assessing the recognition of variable consideration. When consideration is received prior to the Company completing its
performance obligation under the terms of a contract, a contract liability is recorded as deferred income. Deferred income expected
to be recognized as revenue within the twelve months following the balance sheet date is classified as a current liability. In May
2021, the Company entered into a License Agreement (the “New Life Agreement”) with New Life Therapeutics Pte, Ltd.
(“New Life”). In October 2024, the Company entered into the Alkem Agreement. See Note 5 for further discussion of these agreements.
i. Research and development expense
Research
and development expenses include all direct and indirect costs associated with the development of the Company’s biopharmaceutical
products. These expenses include personnel costs, consulting fees, and payments to third parties for research, development, and manufacturing
services. These costs are charged to expense as incurred.
At
the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward
completion of the related project, based on the measure of progress as defined in the contract. Factors the Company considers in preparing
the estimates include costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of its service
providers. Such estimates are subject to change as additional information becomes available. Depending on the timing of payment to the
service providers and the progress that the Company estimates has been made as a result of the service provided, the Company will record
a prepaid expense or accrued liability relating to these costs. Upfront milestone payments made to third parties who perform research
and development services on the Company’s behalf are expensed as services are rendered. Contingent development or regulatory milestone
payments are recognized upon the related resolution of such contingencies.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
j. Foreign currency
Transaction gains and losses resulting from exchange rate changes on transactions
denominated in currencies other than the U.S. dollar are included in operations in the period in which the transaction occurs and reported
within the foreign exchange gain (loss) line item in the consolidated statement of operations.
k. Reverse stock split
On
September 30, 2024, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary
of State of the State of Delaware, which effected a 1-for-8 reverse stock split of the Company’s issued and outstanding shares
of common stock. As a result of the reverse stock split, every eight shares of common stock issued and outstanding
was converted into one share of common stock. The reverse stock split affected all stockholders uniformly and did not alter any stockholder’s
percentage interest in the Company’s equity. No fractional shares were issued in connection with the reverse stock split. Stockholders
who would otherwise be entitled to a fractional share of common stock were instead entitled to receive a proportional cash payment. The
reverse stock split did not change the par value or authorized number of shares of common stock. All common share and per share amounts
presented in the unaudited interim consolidated financial statements and accompanying notes have been retroactively adjusted to reflect
the reverse stock split.
l. Net loss per share
Basic
net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding
during each period (and potential shares of common stock that are exercisable for little or no consideration). Included in basic weighted-average
number of shares of common stock outstanding during the three months ended December 31, 2024 are pre-funded October 2023 warrants to
purchase 99,687 shares of common stock with an exercise price of $0.0008 per share, warrants exercised through the June 2024 inducement
offer for 155,125 shares of common stock that are being held in abeyance as of December 31, 2024 due to beneficial ownership limitations,
and pre-funded December 2024 warrants to purchase 545,500 shares of common stock with an exercise price of $0.0001 per share. Included
in basic weighted-average number of shares of common stock outstanding during the three months ended December 31, 2023 are pre-funded
October 2023 warrants to purchase 192,187 shares of common stock with an exercise price of $0.0008 per share.
Diluted
loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and
stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average
number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities
are not included in the calculation as the impact is anti-dilutive.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule of Potentially Dilutive Securities Excluded from Computation of Diluted Shares
| |
2024 | | |
2023 | |
| |
December
31, | |
| |
2024 | | |
2023 | |
Common
stock warrants August 2021 | |
| 14,031 | | |
| 14,031 | |
Underwriter
warrants August 2021 | |
| 284 | | |
| 284 | |
Chanticleer
warrants | |
| 6 | | |
| 6 | |
Series
C warrants | |
| 2,297 | | |
| 2,297 | |
Series
3 warrants | |
| 1,566 | | |
| 1,566 | |
Unvested
restricted stock units and awards | |
| 17,152 | | |
| 976 | |
Common
stock warrants February 2023 | |
| 31,563 | | |
| 33,982 | |
Underwriter
warrants February 2023 | |
| 1,933 | | |
| 1,933 | |
Common
stock private placement warrants June 2023 | |
| 28,409 | | |
| 28,409 | |
Placement
agent warrants June 2023 | |
| 852 | | |
| 852 | |
Common
stock warrants October 2023 | |
| 354,994 | | |
| 710,931 | |
Underwriter
warrants October 2023 | |
| 10,664 | | |
| 10,664 | |
Placement
agent warrants June 2024 | |
| 14,142 | | |
| — | |
Common
stock warrants June 2024 | |
| 703,125 | | |
| — | |
Common
stock warrants November 2024 | |
| 2,222,222 | | |
| — | |
Common
stock registered direct warrants December 2024 | |
| 1,085,325 | | |
| — | |
Common
stock PIPE warrants December 2024 | |
| 673,000 | | |
| — | |
Total
anti-dilutive weighted average shares | |
| 5,161,565 | | |
| 805,931 | |
m. Recent accounting pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU
2023-07, which is applicable to entities with a single reportable segment, will primarily require enhanced disclosures about significant
segment expenses and enhanced disclosures in interim periods. The guidance in ASU 2023-07 will be applied retrospectively and is effective
for annual reporting periods in fiscal years beginning after December 15, 2023 and interim reporting periods in fiscal years beginning
after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-07
will have on its consolidated financial statements and disclosures.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 is intended
to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the
rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the
income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning
after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated
financial statements and disclosures.
In
November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures
(Subtopic 220-40): Disaggregation of Income Statement Expenses, as subsequently amended by ASU 2025-01 to clarify the effective date,
which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation,
depreciation and amortization) included in certain expense captions presented in the consolidated statement of operations. The guidance
in this ASU is effective for annual reporting periods in fiscal years beginning after December 15, 2026, and interim periods in fiscal
years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial
statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the consolidated
financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its consolidated financial
statements and disclosures.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
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v3.25.0.1
Accrued Expenses and Other Current Liabilities
|
3 Months Ended |
Dec. 31, 2024 |
Payables and Accruals [Abstract] |
|
Accrued Expenses and Other Current Liabilities |
3.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following:
Schedule
of Accrued Expenses and Other Current Liabilities
| |
December
31, 2024 | | |
September
30, 2024 | |
Compensation
and benefits | |
$ | 155,514 | | |
$ | 149,802 | |
Research
and development | |
| 969,684 | | |
| 617,545 | |
Professional
fees | |
| 267,587 | | |
| 173,319 | |
Other | |
| 1,735 | | |
| 1,823 | |
Accrued
expenses and other current liabilities | |
$ | 1,394,520 | | |
$ | 942,489 | |
|
X |
- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/disclosureRef -Topic 720 -SubTopic 30 -Name Accounting Standards Codification -Section 45 -Paragraph 1 -Publisher FASB -URI https://asc.fasb.org/1943274/2147483384/720-30-45-1
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v3.25.0.1
Commitments and Contingencies
|
3 Months Ended |
Dec. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
4.
Commitments and Contingencies
Legal
proceedings
From
time to time, the Company is a party to various lawsuits, claims, and other legal proceedings that arise in the ordinary course of its
business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters
will have a material adverse effect on the Company’s consolidated financial position, results of operations, or cash flows.
License
agreements
In
July 2012, the Company entered into a Discovery Collaboration Agreement (the “Collaboration Agreement”) with XOMA (US) LLC
(“XOMA”), pursuant to which XOMA granted to the Company a non-exclusive, non-transferable license and/or right to use certain
materials, technologies and related information related to discovery, optimization and development of antibodies and related proteins
and to develop and commercialize products thereunder. The Company is obligated to make contingent milestone payments to XOMA totaling
$3.8 million on a product-by-product basis upon the achievement of certain development and approval milestones related to a product.
The Company has also agreed to pay XOMA low single-digit royalties on net sales of products sold by the Company. Royalties on each product
are payable on a country-by-country basis until the later of (i) a specified period of time after the first commercial sale, and (ii)
the date of expiration of the last valid claim in the last-to-expire of the issued patents covered by the Collaboration Agreement. The
first milestone was achieved in April 2022, at which time the Company incurred a $0.5 million license fee which was recorded as acquired
in-process research and development. No license fees were incurred during the three months ended December 31, 2024 and 2023.
In August 2015, the Company entered into a License
Agreement (the “ARES License Agreement”) with Ares Trading (“ARES”), a wholly-owned subsidiary of Merck KGaA.
Under the terms of the ARES License Agreement, as subsequently amended in October 2021, ARES has granted the Company a sublicensable,
exclusive, worldwide, royalty-bearing license on proprietary patents to research, develop, use and commercialize products using atexakin
alfa (“Atexakin”), a low dose formulation of human IL-6 in peripheral neuropathies and vascular complications. Pursuant to
the ARES License Agreement, the Company will pay ARES high single-digit royalties on net sales of products sold by the Company. Royalties
are payable on a product-by-product and country-by-country basis until the later of (i) a specified period of time after the first commercial
sale in such country, and (ii) the last date on which such product is covered by a valid claim in such country. Additionally, the Company
will pay ARES a percentage of all revenue received through sublicensing the IL-6 compound, including revenue from any upfront, milestone,
royalty, maintenance and similar payments, net of certain full time equivalent (“FTE”) costs incurred by the Company pursuant
to such sublicense. The percentage rate owed to ARES on sublicense revenue decreases depending on the point in time of execution of the
relevant sublicense agreement and the development progress accomplished by the Company to that point in time. The upfront cash payments
received by the Company pursuant to the New Life Agreement (see Note 5) were specifically excluded from the scope of the amended ARES
License Agreement. The Company owes ARES $0.1 million in license fees related to sublicense revenue received pursuant to the Alkem Agreement
(see Note 5), which is included in research and development expenses in the unaudited interim consolidated statement of operations for
the three months ended December 31, 2024. No license fees were incurred during the three months ended December 31, 2023.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In
January 2019, the Company entered into a Frame Services and License Agreement (the “Cellca Agreement”) with Sartorius Stedim
Cellca GMBH (“Cellca”), pursuant to which Cellca has granted the Company a worldwide, non-exclusive, perpetual, non-transferable
license to develop, manufacture or have manufactured, use, sell, import, export and/or otherwise commercialize product based on Cellca’s
work to generate a specified transfected cell line and develop an upstream production process for such cell line. The Cellca Agreement
is effective unless terminated by either party by giving six months notice, or by giving 14 days notice if terminated for good cause.
The Company is obligated to make milestone payments to Cellca totaling up to $0.7 million upon the achievement of certain development
and approval milestones if the Buy-Out Option is not exercised. The Company has a Buy-Out Option that will be effective between the time
of completion of a clinical trial and the receipt of regulatory approval for commercialization of product. The cost to exercise the Buy-Out
Option increases on each anniversary of the commencement date of the Buy-Out Option Period, and ranges from $0.1 million to $0.6 million.
The cost to exercise the Buy-Out Option will replace the $0.6 million contingent milestone payment due upon final regulatory approval.
The first milestone was achieved in April 2022, at which time the Company incurred a $0.1 million license fee which was recorded as acquired
in-process research and development. No license fees were incurred during the three months ended December 31, 2024 and 2023.
In
October 2021, the Company entered into a Non-Exclusive License Agreement (the “Brink Agreement”) with Brink Biologics Inc.
(“Brink”), pursuant to which Brink has granted the Company a non-exclusive, non-transferable license and limited right to
sublicense certain materials and related information to develop cell-based assays for batch, quality control, stability, efficacy, potency
or any other type of assay required for production and commercialization of products. During the product development phase, the Company
was obligated to make annual product development license fee payments of approximately $0.1
million. In April 2023, the Brink Agreement was
amended, effective November 2022, to reduce the annual license fee payments to $12,000
for storage. If materials are removed from storage
during the product development phase, the annual product development license fee of approximately $0.1
million will apply. If a product achieves commercial
status, the Company is obligated to make a commercial product license fee payment of approximately $0.1
million per commercial product. The amended agreement
has an initial term of one year and will automatically renew for one additional year unless terminated or converted to a product development
license. After the second year, the license will automatically convert to a full license requiring a product development or a commercial
product license fee unless the parties mutually agree to terminate the agreement. The Company incurred $12,000 in license fees during
the three months ended December 31, 2024 and 2023, which were recorded as acquired in-process research and development and included in
research and development expenses in the unaudited interim consolidated statements of operations.
In
February 2022, the Company entered into a Biological Materials License Agreement (the “InvivoGen Agreement”) with InvivoGen
SAS (“InvivoGen”), pursuant to which InvivoGen has granted the Company a worldwide, non-exclusive license to use certain
reporter cells for research, development and/or quality control purposes. The InvivoGen Agreement has an initial term of three years
and may be extended for two additional three-year periods upon written notice by the Company and payment of an approximately €0.1
million fee per extension (approximately $0.1 million as of December 31, 2024). No license fees were incurred during the three months ended
December 31, 2024 and 2023.
Collaboration agreement
In August 2024, the Company entered into a Master
Clinical Collaboration Agreement (the “SOC Agreement”) with the Sarcoma Oncology Center (“SOC”) to advance the
development of SON-1210. An Innovative Immuno Oncology Center funded by the SOC will conduct an investigator-initiated Phase 1/2a study
of SON-1210 in pancreatic cancer. The Company will provide the study drug and provide support services for the study. If the Company establishes
a partnership with a third party prior to the initiation of the initial efficacy combination trial under this collaboration, the Company
will incur, payable to the SOC, a one-time fee equal to the greater of 5% or $1.5 million from the first upfront payment received from
such third party partnership.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Research
and development agreement
In
December 2021, the Company entered into a Research and Development Agreement (the “Navigo Agreement”) with Navigo
Proteins GmbH (“Navigo”), pursuant to which Navigo will perform specified evaluation and development procedures to
evaluate certain materials to determine their commercial potential. Under the terms of the Navigo Agreement, the Company has granted
Navigo a royalty-free, non-exclusive, worldwide, non-sublicensable, non-transferable right and license to use certain technology to
perform the evaluation and development activities, and Navigo has granted the Company (i) an exclusive, worldwide, perpetual,
irrevocable, sublicensable, transferable, royalty-free right and license to research, develop, use, sell, have sold, distribute,
import or otherwise commercially exploit certain materials, and (ii) a non-exclusive, worldwide, perpetual, sublicensable,
non-transferable right and license to make or have made such materials. The Company incurred a $0.1 million
technology access fee upon execution of the Navigo Agreement, at which time it was recorded as acquired in-process research. The
Company is obligated to make contingent milestone payments to Navigo totaling up to $1.0 million
upon the achievement of certain evaluation and development milestones as outlined in the Navigo Agreement, of which $0.3
million of evaluation milestones have been previously recognized. No milestones
were achieved and no license
fees were incurred during the three months ended December 31, 2024 and 2023.
Employment
agreements
The
Company has entered into employment contracts with its officers and certain employees that provide for severance and continuation of
benefits in the event of termination of employment either by the Company without cause or by the employee for good reason, both as defined
in the contract. In addition, in the event of termination of employment following a change in control, as defined, either by the Company
without cause or by the employee for good reason, any unvested portion of the employee’s initial stock option grant becomes immediately
vested.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.25.0.1
Collaboration Revenue
|
3 Months Ended |
Dec. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Collaboration Revenue |
5.
Collaboration Revenue
New
Life Agreement
Under the New Life Agreement, the Company granted
New Life an exclusive license (with the right to sublicense) to develop and commercialize pharmaceutical preparations containing a specific
recombinant human IL-6, SON-080 (the “Compound”) (such preparations, the “Products”) for the prevention, treatment
or palliation of DPN in humans (the “DPN Field”) in Malaysia, Singapore, Indonesia, Thailand, Philippines, Vietnam, Brunei,
Myanmar, Lao PDR and Cambodia (the “Exclusive Territory”). New Life paid the Company an aggregate of $1.0 million in non-refundable
upfront cash payments in connection with the execution of the New Life Agreement. The related collaboration revenue was fully recognized
by December 31, 2023, as the Company had completed its performance obligations under the New Life Agreement. In December 2024, New Life
informed the Company that it has elected to move its business in a different direction and provided the Company with written notice of
its intention to exercise its Give Back Option, which is the right to give back the rights with respect to Products in the DPN Field in
one or more countries in the Exclusive Territory. The exercise of the Give Back Option is subject to the negotiation and mutual agreement
of terms between the Company and New Life.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Alkem
Agreement
Under the Alkem Agreement entered
into on October 8, 2024 (see Note 1), the Company
granted Alkem an exclusive license (with the right to sublicense) to research, develop, manufacture, import, export, market, use and
commercialize pharmaceutical products containing its IL-6 (SON-080) asset (or any derivatives, fragments or conjugates thereof) (the
“Compounds”) (such products, the “Products”) for the treatment of DPN (the “DPN Field”) and to
manufacture, import, export, market, use and commercialize Products for the treatment of CIPN and autonomic neuropathy (together
with the DPN Field, the “Fields”) in India. Except as provided for in the Alkem Agreement, the Company agreed not to
develop, use, sell, offer or otherwise commercialize any Compounds or Products for use in the DPN Field in India during the term of
the Alkem Agreement. The Company retains all rights to manufacture Compounds and Products anywhere in the world. The
Company and Alkem will enter into a follow-on supply agreement pursuant to which the Company will manufacture for Alkem Compounds
and Products for post-Phase 2 clinical development and commercialization in accordance with the Alkem Agreement on terms to be
negotiated by the parties. Pursuant to the terms of the Alkem Agreement, Alkem will bear the cost of, and be responsible for, among
other things, conducting clinical studies and additional non-clinical studies (if any, subject to both parties’ approval),
preparing and filing applications for regulatory approval and undertaking other developmental and regulatory activities for
commercializing Products in the DPN Field in India. Alkem will own and maintain all regulatory filings and approvals for Products in
India. Upon payment of a Clinical Data Access Fee (as defined in the Alkem Agreement), the Company will have rights to access and
use the data generated by the clinical trials conducted in connection with the Alkem Agreement. Under the terms of the Alkem
Agreement, Alkem will pay the Company $1.0
million in upfront payments and up to an additional $1.0
million in milestone payments. Additionally, the Company is entitled to receive a royalty equal to a percentage in the low double
digits of the net sales of the Product upon commercialization of SON-080 in India, less certain expenses as set forth in the Alkem
Agreement.
Revenue
recognition
The Company first assessed the Alkem Agreement
under ASC 808, Collaborative Arrangements (“ASC 808”), to determine whether the Alkem Agreement or units of accounts
within the Alkem Agreement represent a collaborative arrangement based on the risks and rewards and activities of the parties. The Company
applied relevant guidance from ASC 606, Revenue from Contracts with Customers (“ASC 606”), to evaluate the appropriate
accounting for the collaborative arrangement with Alkem.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In accordance with this guidance, the Company
identified the following obligations under the Alkem arrangement: (i) License to research, develop, market, import, use and commercialize
the Product in the DPN field in India (the “License”); and (ii) supply of Compound for a Phase 2 clinical trial (“Supply”).
The future supply agreement for post-Phase 2 clinical development represents an optional purchase, which will be accounted for as a separate
contract, and the Company did not identify any material right to be present. The Company determined that the License and Supply are not
distinct from each other and therefore combined these material promises into a single performance obligation. The Company determined the
initial transaction price of the single performance obligation to be $1.0 million, as the future development and commercialization milestones,
which represent variable consideration, are subject to constraint at inception. At the end of each subsequent reporting period, the Company
will reevaluate the probability of achievement of the future development and commercialization milestones subject to constraint and, if
necessary, will adjust its estimate of the overall transaction price. Any such adjustments will be recorded on a cumulative catch-up basis.
For the sales-based royalties, the Company will recognize revenue when the related sales occur.
Collaboration revenue from the single
performance obligation related to the Alkem Agreement was recognized at the point-in-time at which the Company transferred the License
and Supply to Alkem. Collaboration revenue from the single performance obligation related to the New Life Agreement was recognized over
the estimated performance of the research and development activities. The Company recognized $1.0 million and $18,626 of collaboration
revenue for the three months ended December 31, 2024 and 2023, respectively. As of December 31, 2024, the Company has recorded
a contract asset for $0.5 million related to the Alkem Agreement, which represents the unbilled amount related to the single performance
obligation and is included in unbilled collaboration revenue in the unaudited interim consolidated balance sheet.
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v3.25.0.1
Stockholders’ Equity (Deficit)
|
3 Months Ended |
Dec. 31, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity (Deficit) |
6.
Stockholders’ Equity (Deficit)
October
2023 underwritten public offering
On
October 26, 2023, the Company closed a public offering of common stock and certain warrants through Chardan
and Ladenburg Thalmann & Co. Inc. as underwriters, for net proceeds of $3.9 million through the issuance and sale of 163,281 shares
of its common stock and, to certain investors, pre-funded warrants to purchase 192,187 shares of common stock, and accompanying common
warrants to purchase up to an aggregate of 710,931 shares of its common stock. Each share of common stock and pre-funded warrant to purchase
one share of common stock was sold together with a common warrant to purchase two shares of common stock. The public offering price of
each share of common stock and accompanying common warrant was $12.80 and the public offering price of each pre-funded warrant and accompanying
common warrant was $12.7992. The common warrants were immediately exercisable at a price of $12.80 per share of common stock, expire
five years from the date of issuance and contain an alternative cashless exercise provision. In connection with the June 2024 inducement
offer, the exercise price was decreased to $9.60 per share of common stock for common warrants that remained unexercised at the time
of the offer. The pre-funded warrants were immediately exercisable at any time, until exercised in full, at a price of $0.0008 per share
of common stock. In addition, warrants to purchase 10,664 shares of common stock were issued to the underwriters as compensation for
their services related to the offering. These common stock warrants have an exercise price of $16.00 per share and expire five years
from the date of issuance.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
Committed
equity facility
On
May 2, 2024, the Company entered into the Purchase Agreement and a Registration Rights Agreement (the “Registration Rights
Agreement”), each with Chardan, related to a “ChEF,” Chardan’s committed equity facility, or the Facility
(see Note 1). Pursuant to the Purchase Agreement, the Company has the right from time to time at its option to sell to Chardan up to
$25.0
million in aggregate gross purchase price of newly issued shares of the Company’s common stock, of which $24.9
million is available to be sold as of December 31, 2024. The Facility will allow the Company to raise primary equity on a periodic
basis at its sole discretion depending on a variety of factors including, among other things, market conditions, the trading price
of the common stock, and determinations by the Company regarding the use of proceeds of such common stock. The purchase price of the
shares of common stock will be determined by reference to the Volume Weighted Average Price (“VWAP”) of the common stock
during the applicable purchase period, less a fixed 4%
discount to such VWAP, and the total shares to be purchased on any day may not exceed 20% of the trading volume of the
Company’s common stock during the applicable purchase period. The Purchase Agreement will be effective for a 36-month period
ending May 16, 2027. Due to certain pricing and settlement provisions, the Purchase Agreement qualifies as a standby equity purchase
agreement and includes an embedded put option and an embedded forward contract. The Company accounts for the embedded features in
the Purchase Agreement as derivatives measured at fair value, with changes in fair value recognized in the consolidated statement
of operations. The derivatives associated with the Purchase Agreement have been deemed de minimis. The Company did not
sell any shares of common stock pursuant to the Purchase Agreement during the three months ended December 31, 2024.
November
2024 underwritten public offering
On
November 7, 2024, the Company closed a public offering of common stock and certain warrants through Chardan, as underwriter, for net
proceeds of $4.2 million through the issuance and sale of 155,000 shares of its common stock, pre-funded warrants to purchase up to
956,111 shares of common stock, and accompanying common warrants to purchase up to an aggregate of 2,222,222 shares of its common stock.
Each share of common stock and pre-funded warrant to purchase one share of common stock was sold together with a common warrant to purchase
two shares of common stock. The public offering price of each share of common stock and accompanying common warrant was $4.50 and the
public offering price of each pre-funded warrant and accompanying common warrant was $4.4999. The common warrants were immediately exercisable
at a price of $4.50 per share of common stock, expire five years from the date of issuance and contain an alternative cashless exercise
provision. The pre-funded warrants were immediately exercisable at any time, until exercised in full, at a price of $0.0001 per share
of common stock. All of the pre-funded warrants have been exercised as of December 31, 2024.
December
2024 registered direct and PIPE offering
On
December 10, 2024, the Company closed a registered direct offering with institutional investors for the issuance and sale of 768,000
shares of its common stock, pre-funded warrants to purchase up to 317,325
shares of common stock, and accompanying warrants to purchase up to an aggregate of 1,085,325
shares of its common stock. Each share of common stock and pre-funded warrant to purchase one share of common stock was sold
together with a common warrant to purchase one share of common stock. The offering price of each share of common stock and
accompanying common warrant was $2.23 and the offering price of each pre-funded warrant and accompanying common warrant was $2.2299,
priced at-the-market under the rules of the Nasdaq Stock Market. The registered direct warrants were immediately exercisable at a
price of $2.10
per share, expire five
years from the date of issuance and contain an alternative cashless exercise provision. The pre-funded warrants were
immediately exercisable at any time, until exercised in full, at a price of $0.0001
per share of common stock. All of the pre-funded warrants have been exercised as of December 31, 2024.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
Company closed a concurrent private placement with an existing investor for the issuance and sale of 127,500
shares of its common stock, pre-funded warrants to purchase up to 545,500
shares of common stock, and accompanying warrants to purchase up to an aggregate 673,000
shares of its common stock. Each share of common stock and pre-funded warrant to purchase one share of common stock was sold in the
private placement (“PIPE”) together with a common warrant to purchase one share of common stock. The PIPE offering price
of each share of common stock and accompanying common warrant was $2.23 and the PIPE offering price of each pre-funded warrant and accompanying common warrant was $2.2299,
priced at-the-market under the rules of the Nasdaq Stock Market. The PIPE warrants were immediately exercisable at a price of $2.10
per share, expire five
years from the date of issuance and contain an alternative cashless exercise provision. The pre-funded warrants were
immediately exercisable at any time, until exercised in full, at a price of $0.0001
per share of common stock.
The
Company raised net proceeds of approximately $3.5 million from the registered direct and PIPE offering.
Common
stock warrants
As
of December 31, 2024, the following equity-classified warrants and related terms were outstanding:
Schedule
of Warrants Outstanding
| |
Warrants
Outstanding | | |
Exercise
Price | | |
Expiration
Date | |
Common
stock warrants August 2021 | |
| 14,031 | | |
$ | 2,094.4000 | | |
| August
24, 2026 | |
Underwriter
warrants August 2021 | |
| 284 | | |
$ | 2,618.0000 | | |
| August
19, 2026 | |
Chanticleer
warrants | |
| 6 | | |
| $144,144.0000
- $224,224.0000 | | |
| April
30, 2027 - December 17, 2028 | |
Series
C warrants | |
| 2,297 | | |
$ | 7,860.1600 | | |
| October
16, 2025 | |
Series
3 warrants | |
| 1,566 | | |
$ | 717.0240 | | |
| August
15, 2027 | |
Common
stock warrants February 2023 | |
| 31,563 | | |
$ | 190.0800 | | |
| February
10, 2028 | |
Underwriter
warrants February 2023 | |
| 1,933 | | |
$ | 237.6000 | | |
| February
8, 2028 | |
Common
stock private placement warrants June 2023 | |
| 28,409 | | |
$ | 12.4000 | | |
| June
21, 2029 | |
Placement
agent warrants June 2023 | |
| 852 | | |
$ | 118.7824 | | |
| December
30, 2026 | |
Common
stock warrants October 2023 | |
| 354,994 | | |
$ | 9.6000 | | |
| October
27, 2028 | |
Pre-funded
warrants October 2023 | |
| 99,687 | | |
$ | 0.0008 | | |
| — | |
Underwriter
warrants October 2023 | |
| 10,664 | | |
$ | 16.0000 | | |
| October
24, 2028 | |
Placement
agent warrants June 2024 | |
| 14,142 | | |
$ | 14.8800 | | |
| June
19, 2029 | |
Common
stock warrants June 2024 | |
| 703,125 | | |
$ | 12.4000 | | |
| June
21, 2029 | |
Common
stock warrants November 2024 | |
| 2,222,222 | | |
$ | 4.5000 | | |
| November
7, 2029 | |
Common
stock registered direct warrants December 2024 | |
| 1,085,325 | | |
$ | 2.1000 | | |
| December
9, 2029 | |
Common
stock PIPE warrants December 2024 | |
| 673,000 | | |
$ | 2.1000 | | |
| December
9, 2029 | |
Pre-funded
warrants December 2024 | |
| 545,500 | | |
$ | 0.0001 | | |
| — | |
Total | |
| 5,789,600 | | |
| | | |
| | |
Due
to beneficial ownership limitations, 187,500
shares of common stock related to warrants that were exercised in June 2024 through the inducement offer were being held in
abeyance. During the three months ended December 31, 2024, 32,375
of these shares of common stock were released from abeyance, resulting in 155,125 shares of common stock held in abeyance as of December 31, 2024.
During
the three months ended December 31, 2024, 2,419 warrants were net share settled, resulting in the issuance of 1,209 shares of common
stock, and 1,273,436 pre-funded warrants were exercised on a cash basis for de minimis proceeds.
During
the three months ended December 31, 2023, 3,590 warrants were net share settled, resulting in the issuance of 1,795 shares of common
stock, and 4,302 warrants were abandoned by the warrant holder.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
|
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- DefinitionThe entire disclosure for equity.
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v3.25.0.1
Share-Based Compensation
|
3 Months Ended |
Dec. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Share-Based Compensation |
7.
Share-Based Compensation
In April 2020, the Company adopted the
2020 Omnibus Equity Incentive Plan (the “Plan”). There were 5
shares available for issuance under the Plan as of December 31, 2024. On January 1, 2025, the total number
of shares authorized under the Plan increased to 120,302. The Plan increases the amount of shares issuable under
the Plan by four percent of the outstanding shares of common stock at each January 1, each year. The Plan permits the granting of share-based
awards, including stock options, restricted stock units and awards, stock appreciation rights and other types of awards as deemed appropriate,
in each case, in accordance with the terms of the Plan. The terms of the awards are determined by the Company’s Board of Directors.
Restricted
stock units and awards
On
January 1, 2024, 9,175 restricted stock units (“RSUs”) and 7,977 restricted stock awards (“RSAs”) were granted,
100% of which vested on January 1, 2025. Any unvested RSUs or RSAs will be forfeited upon termination of services. The fair value of
an RSU or RSA is equal to the fair market value of the Company’s common stock on the date of grant. RSU and RSA expense is amortized
straight-line over the vesting period.
The
Company recorded share-based compensation expense associated with the RSUs and RSAs in its accompanying unaudited interim consolidated
statements of operations as follows:
Schedule
of Share-based Compensation Expense
| |
2024 | | |
2023 | |
| |
Three
Months Ended December 31, | |
| |
2024 | | |
2023 | |
Research
and development | |
$ | 28,268 | | |
$ | 24,554 | |
General
and administrative | |
| 32,127 | | |
| 25,451 | |
Share-based
compensation | |
$ | 60,395 | | |
$ | 50,005 | |
The
following table summarizes RSU activity under the Plan:
Schedule
of Restricted Stock Units Activity
| |
| | |
Weighted | |
| |
| | |
Average
Grant | |
| |
RSU | | |
Date
Fair Value | |
Unvested
balance at December 31, 2024 | |
| 9,175 | | |
$ | 14.08 | |
During
the three months ended December 31, 2024, there were no RSUs granted, vested or forfeited. As of December 31, 2024, there was
no unrecognized compensation expense relating to unvested RSUs granted.
The
following table summarizes RSA activity under the Plan:
Schedule
of Restricted Stock Awards Activity
| |
| | |
Weighted | |
| |
| | |
Average
Grant | |
| |
RSA | | |
Date
Fair Value | |
Unvested
balance at December 31, 2024 | |
| 7,977 | | |
$ | 14.08 | |
During
the three months ended December 31, 2024, there were no RSAs granted, vested or forfeited. As of December 31, 2024, there was
no unrecognized compensation expense relating to unvested RSAs granted.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.25.0.1
Subsequent Events
|
3 Months Ended |
Dec. 31, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
8.
Subsequent Events
The
Company has evaluated subsequent events from the balance sheet date through February 13, 2025, the date at which the unaudited interim
consolidated financial statements were available to be issued.
Subsequent to December 31, 2024, the Company
sold 58,270 shares of common stock pursuant to the Purchase Agreement for net proceeds of $0.1 million.
The
Company received preliminary approval of its application to sell up to $0.8 million of its New Jersey state net operating losses through
the Program (see Note 1). In February 2025, the Company identified a buyer. As outlined in the Program, although the sale has been approved
and a buyer identified, the Company must still execute an arrangement with such buyer to consummate a sale of the state net operating
losses.
On
February 10, 2025, Jay Cross submitted his resignation as our Chief Financial Officer, effective February 21, 2025. In connection
with Mr. Cross’s resignation, on February 12, 2025, the Company’s board of directors (the “Board”) appointed
Donald Griffith, CPA, the Company’s current Controller and a member of the Board, to succeed Mr. Cross as its Chief Financial
Officer effective February 21, 2025.
On
February 12, 2025, Stephen McAndrew, Ph.D., the Company’s Senior Vice President of Business Development, was appointed as
the Company’s Chief Business Officer. In connection with his appointment, Dr. McAndrew entered into an employment agreement with
the Company, dated February 12, 2025 (the “McAndrew Agreement”). Dr. McAndrew’s employment as the Company’s Chief
Business Officer will commence on February 17, 2025. Pursuant to the McAndrew Agreement, Dr. McAndrew is entitled to, among other things,
(i) an annual gross base salary of $330,000 (“Base Salary”) and (ii) eligibility for a performance-based cash bonus of up
to 35% of the Base Salary, as determined by the Board.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.25.0.1
Summary of Significant Accounting Policies (Policies)
|
3 Months Ended |
Dec. 31, 2024 |
Accounting Policies [Abstract] |
|
Basis of presentation |
a. Basis of presentation
The
accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information as found in the Accounting Standards Codification (“ASC”)
and Accounting Standards Updates (ASUs”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management,
the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily
of accruals, estimates and assumptions that impact the unaudited interim consolidated financial statements) considered necessary to present
fairly the Company’s financial position as of December 31, 2024 and its results of operations and cash flows for the three
months ended December 31, 2024 and 2023. The unaudited interim consolidated financial statements presented herein do not contain
all of the required disclosures under U.S. GAAP for annual financial statements and should be read in conjunction with the annual audited
consolidated financial statements and related notes of Sonnet as of and for the year ended September 30, 2024 included in the Company’s
Annual Report on Form 10-K for the fiscal year ended September 30, 2024. The results of operations for the interim periods are not
necessarily indicative of the results of operations to be expected for the full year.
|
Consolidation |
b. Consolidation
The
unaudited interim consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany
accounts and transactions have been eliminated in consolidation.
|
Use of estimates |
c. Use of estimates
The
preparation of the unaudited interim consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Significant estimates
and assumptions reflected in these unaudited interim consolidated financial statements include the accrual of research and development
expenses. Estimates and assumptions are periodically reviewed in-light of changes in circumstances, facts and experience. Changes in
estimates are recorded in the period in which they become known. Actual results could differ from management’s estimates.
|
Incentive tax receivable |
d. Incentive tax receivable
Subsidiary
is eligible to participate in an Australian research and development tax incentive program. As part of this program, Subsidiary is eligible
to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by Subsidiary
in Australia. The
cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian) during the reimbursable
period. The Company estimates the amount of cash
refund it expects to receive related to the Australian research and development tax incentive program and records the incentive when
it is probable (i) the Company will comply with relevant conditions of the program and (ii) the incentive will be received. As of December 31,
2024, the Company’s estimate of the amount of cash refund it expects to receive for eligible spending related to the Australian
research and development tax incentive program was $0.2
million. For each of the three months ended December 31,
2024 and 2023, $0.2 million for the expected net cash refund related to the tax incentive program was included as a reduction in research
and development expenses. In November 2024, the Company received $0.7
million from the Australian government related
to eligible research and development expenses for the year ended September 30, 2024. In December 2023, the Company received $0.8 million from the Australian government related to eligible research and
development expenses for the year ended September 30, 2023.
|
Property and equipment |
e. Property and equipment
Property
and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Expenditures
for repairs and maintenance that do not extend the estimated useful life or improve an asset are expensed as incurred. Upon retirement
or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts, and any
resulting gain or loss is included in the consolidated statement of operations.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
|
Deferred offering costs |
f. Deferred offering costs
Legal
and other costs incurred in relation to equity offerings are capitalized as deferred offering costs and charged against the proceeds
from equity offerings when received. If a financing is abandoned, deferred offering costs are expensed.
|
Derivative liability |
g. Derivative liability
The
Company evaluates all features contained in financing agreements to determine if there are any embedded derivatives that require separate
accounting from the underlying agreement. An embedded derivative that requires separation is accounted for as a separate asset or liability
from the host agreement. The derivative asset or liability is accounted for at fair value, with changes in fair value recognized in the
consolidated statement of operations. The Company determined that certain features under the Purchase Agreement (see Note 6) qualified
as embedded derivatives. The derivative liability is accounted for separately from the Purchase Agreement at fair value, which
has been deemed de minimis.
|
Collaboration revenue |
h. Collaboration revenue
Collaboration
arrangements may contain multiple components, which may include (i) licenses; (ii) research and development activities; and (iii) the
manufacturing and supply of certain materials. Payments pursuant to these arrangements may include non-refundable payments, upfront payments,
milestone payments upon the achievement of significant regulatory and development events, sales milestones and royalties on product sales.
The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in
a future period.
In
determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under a collaboration arrangement,
the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of
whether the promised goods or services are performance obligations, including whether they are capable of being distinct; (iii) measurement
of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance
obligations; and (v) recognition of revenue as the Company satisfies each performance obligation.
The
Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations,
allocating transaction price to performance obligations within a contract, determining when performance obligations have been met,
and assessing the recognition of variable consideration. When consideration is received prior to the Company completing its
performance obligation under the terms of a contract, a contract liability is recorded as deferred income. Deferred income expected
to be recognized as revenue within the twelve months following the balance sheet date is classified as a current liability. In May
2021, the Company entered into a License Agreement (the “New Life Agreement”) with New Life Therapeutics Pte, Ltd.
(“New Life”). In October 2024, the Company entered into the Alkem Agreement. See Note 5 for further discussion of these agreements.
|
Research and development expense |
i. Research and development expense
Research
and development expenses include all direct and indirect costs associated with the development of the Company’s biopharmaceutical
products. These expenses include personnel costs, consulting fees, and payments to third parties for research, development, and manufacturing
services. These costs are charged to expense as incurred.
At
the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward
completion of the related project, based on the measure of progress as defined in the contract. Factors the Company considers in preparing
the estimates include costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of its service
providers. Such estimates are subject to change as additional information becomes available. Depending on the timing of payment to the
service providers and the progress that the Company estimates has been made as a result of the service provided, the Company will record
a prepaid expense or accrued liability relating to these costs. Upfront milestone payments made to third parties who perform research
and development services on the Company’s behalf are expensed as services are rendered. Contingent development or regulatory milestone
payments are recognized upon the related resolution of such contingencies.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
|
Foreign currency |
j. Foreign currency
Transaction gains and losses resulting from exchange rate changes on transactions
denominated in currencies other than the U.S. dollar are included in operations in the period in which the transaction occurs and reported
within the foreign exchange gain (loss) line item in the consolidated statement of operations.
|
Reverse stock split |
k. Reverse stock split
On
September 30, 2024, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary
of State of the State of Delaware, which effected a 1-for-8 reverse stock split of the Company’s issued and outstanding shares
of common stock. As a result of the reverse stock split, every eight shares of common stock issued and outstanding
was converted into one share of common stock. The reverse stock split affected all stockholders uniformly and did not alter any stockholder’s
percentage interest in the Company’s equity. No fractional shares were issued in connection with the reverse stock split. Stockholders
who would otherwise be entitled to a fractional share of common stock were instead entitled to receive a proportional cash payment. The
reverse stock split did not change the par value or authorized number of shares of common stock. All common share and per share amounts
presented in the unaudited interim consolidated financial statements and accompanying notes have been retroactively adjusted to reflect
the reverse stock split.
|
Net loss per share |
l. Net loss per share
Basic
net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding
during each period (and potential shares of common stock that are exercisable for little or no consideration). Included in basic weighted-average
number of shares of common stock outstanding during the three months ended December 31, 2024 are pre-funded October 2023 warrants to
purchase 99,687 shares of common stock with an exercise price of $0.0008 per share, warrants exercised through the June 2024 inducement
offer for 155,125 shares of common stock that are being held in abeyance as of December 31, 2024 due to beneficial ownership limitations,
and pre-funded December 2024 warrants to purchase 545,500 shares of common stock with an exercise price of $0.0001 per share. Included
in basic weighted-average number of shares of common stock outstanding during the three months ended December 31, 2023 are pre-funded
October 2023 warrants to purchase 192,187 shares of common stock with an exercise price of $0.0008 per share.
Diluted
loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and
stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average
number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities
are not included in the calculation as the impact is anti-dilutive.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule of Potentially Dilutive Securities Excluded from Computation of Diluted Shares
| |
2024 | | |
2023 | |
| |
December
31, | |
| |
2024 | | |
2023 | |
Common
stock warrants August 2021 | |
| 14,031 | | |
| 14,031 | |
Underwriter
warrants August 2021 | |
| 284 | | |
| 284 | |
Chanticleer
warrants | |
| 6 | | |
| 6 | |
Series
C warrants | |
| 2,297 | | |
| 2,297 | |
Series
3 warrants | |
| 1,566 | | |
| 1,566 | |
Unvested
restricted stock units and awards | |
| 17,152 | | |
| 976 | |
Common
stock warrants February 2023 | |
| 31,563 | | |
| 33,982 | |
Underwriter
warrants February 2023 | |
| 1,933 | | |
| 1,933 | |
Common
stock private placement warrants June 2023 | |
| 28,409 | | |
| 28,409 | |
Placement
agent warrants June 2023 | |
| 852 | | |
| 852 | |
Common
stock warrants October 2023 | |
| 354,994 | | |
| 710,931 | |
Underwriter
warrants October 2023 | |
| 10,664 | | |
| 10,664 | |
Placement
agent warrants June 2024 | |
| 14,142 | | |
| — | |
Common
stock warrants June 2024 | |
| 703,125 | | |
| — | |
Common
stock warrants November 2024 | |
| 2,222,222 | | |
| — | |
Common
stock registered direct warrants December 2024 | |
| 1,085,325 | | |
| — | |
Common
stock PIPE warrants December 2024 | |
| 673,000 | | |
| — | |
Total
anti-dilutive weighted average shares | |
| 5,161,565 | | |
| 805,931 | |
|
Recent accounting pronouncements |
m. Recent accounting pronouncements
In
November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU
2023-07, which is applicable to entities with a single reportable segment, will primarily require enhanced disclosures about significant
segment expenses and enhanced disclosures in interim periods. The guidance in ASU 2023-07 will be applied retrospectively and is effective
for annual reporting periods in fiscal years beginning after December 15, 2023 and interim reporting periods in fiscal years beginning
after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-07
will have on its consolidated financial statements and disclosures.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 is intended
to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the
rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the
income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning
after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its consolidated
financial statements and disclosures.
In
November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures
(Subtopic 220-40): Disaggregation of Income Statement Expenses, as subsequently amended by ASU 2025-01 to clarify the effective date,
which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation,
depreciation and amortization) included in certain expense captions presented in the consolidated statement of operations. The guidance
in this ASU is effective for annual reporting periods in fiscal years beginning after December 15, 2026, and interim periods in fiscal
years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial
statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the consolidated
financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its consolidated financial
statements and disclosures.
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v3.25.0.1
Summary of Significant Accounting Policies (Tables)
|
3 Months Ended |
Dec. 31, 2024 |
Accounting Policies [Abstract] |
|
Schedule of Potentially Dilutive Securities Excluded from Computation of Diluted Shares |
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule of Potentially Dilutive Securities Excluded from Computation of Diluted Shares
| |
2024 | | |
2023 | |
| |
December
31, | |
| |
2024 | | |
2023 | |
Common
stock warrants August 2021 | |
| 14,031 | | |
| 14,031 | |
Underwriter
warrants August 2021 | |
| 284 | | |
| 284 | |
Chanticleer
warrants | |
| 6 | | |
| 6 | |
Series
C warrants | |
| 2,297 | | |
| 2,297 | |
Series
3 warrants | |
| 1,566 | | |
| 1,566 | |
Unvested
restricted stock units and awards | |
| 17,152 | | |
| 976 | |
Common
stock warrants February 2023 | |
| 31,563 | | |
| 33,982 | |
Underwriter
warrants February 2023 | |
| 1,933 | | |
| 1,933 | |
Common
stock private placement warrants June 2023 | |
| 28,409 | | |
| 28,409 | |
Placement
agent warrants June 2023 | |
| 852 | | |
| 852 | |
Common
stock warrants October 2023 | |
| 354,994 | | |
| 710,931 | |
Underwriter
warrants October 2023 | |
| 10,664 | | |
| 10,664 | |
Placement
agent warrants June 2024 | |
| 14,142 | | |
| — | |
Common
stock warrants June 2024 | |
| 703,125 | | |
| — | |
Common
stock warrants November 2024 | |
| 2,222,222 | | |
| — | |
Common
stock registered direct warrants December 2024 | |
| 1,085,325 | | |
| — | |
Common
stock PIPE warrants December 2024 | |
| 673,000 | | |
| — | |
Total
anti-dilutive weighted average shares | |
| 5,161,565 | | |
| 805,931 | |
|
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v3.25.0.1
Accrued Expenses and Other Current Liabilities (Tables)
|
3 Months Ended |
Dec. 31, 2024 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses and Other Current Liabilities |
Accrued
expenses and other current liabilities consisted of the following:
Schedule
of Accrued Expenses and Other Current Liabilities
| |
December
31, 2024 | | |
September
30, 2024 | |
Compensation
and benefits | |
$ | 155,514 | | |
$ | 149,802 | |
Research
and development | |
| 969,684 | | |
| 617,545 | |
Professional
fees | |
| 267,587 | | |
| 173,319 | |
Other | |
| 1,735 | | |
| 1,823 | |
Accrued
expenses and other current liabilities | |
$ | 1,394,520 | | |
$ | 942,489 | |
|
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v3.25.0.1
Stockholders’ Equity (Deficit) (Tables)
|
3 Months Ended |
Dec. 31, 2024 |
Equity [Abstract] |
|
Schedule of Warrants Outstanding |
As
of December 31, 2024, the following equity-classified warrants and related terms were outstanding:
Schedule
of Warrants Outstanding
| |
Warrants
Outstanding | | |
Exercise
Price | | |
Expiration
Date | |
Common
stock warrants August 2021 | |
| 14,031 | | |
$ | 2,094.4000 | | |
| August
24, 2026 | |
Underwriter
warrants August 2021 | |
| 284 | | |
$ | 2,618.0000 | | |
| August
19, 2026 | |
Chanticleer
warrants | |
| 6 | | |
| $144,144.0000
- $224,224.0000 | | |
| April
30, 2027 - December 17, 2028 | |
Series
C warrants | |
| 2,297 | | |
$ | 7,860.1600 | | |
| October
16, 2025 | |
Series
3 warrants | |
| 1,566 | | |
$ | 717.0240 | | |
| August
15, 2027 | |
Common
stock warrants February 2023 | |
| 31,563 | | |
$ | 190.0800 | | |
| February
10, 2028 | |
Underwriter
warrants February 2023 | |
| 1,933 | | |
$ | 237.6000 | | |
| February
8, 2028 | |
Common
stock private placement warrants June 2023 | |
| 28,409 | | |
$ | 12.4000 | | |
| June
21, 2029 | |
Placement
agent warrants June 2023 | |
| 852 | | |
$ | 118.7824 | | |
| December
30, 2026 | |
Common
stock warrants October 2023 | |
| 354,994 | | |
$ | 9.6000 | | |
| October
27, 2028 | |
Pre-funded
warrants October 2023 | |
| 99,687 | | |
$ | 0.0008 | | |
| — | |
Underwriter
warrants October 2023 | |
| 10,664 | | |
$ | 16.0000 | | |
| October
24, 2028 | |
Placement
agent warrants June 2024 | |
| 14,142 | | |
$ | 14.8800 | | |
| June
19, 2029 | |
Common
stock warrants June 2024 | |
| 703,125 | | |
$ | 12.4000 | | |
| June
21, 2029 | |
Common
stock warrants November 2024 | |
| 2,222,222 | | |
$ | 4.5000 | | |
| November
7, 2029 | |
Common
stock registered direct warrants December 2024 | |
| 1,085,325 | | |
$ | 2.1000 | | |
| December
9, 2029 | |
Common
stock PIPE warrants December 2024 | |
| 673,000 | | |
$ | 2.1000 | | |
| December
9, 2029 | |
Pre-funded
warrants December 2024 | |
| 545,500 | | |
$ | 0.0001 | | |
| — | |
Total | |
| 5,789,600 | | |
| | | |
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v3.25.0.1
Share-Based Compensation (Tables)
|
3 Months Ended |
Dec. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Share-based Compensation Expense |
The
Company recorded share-based compensation expense associated with the RSUs and RSAs in its accompanying unaudited interim consolidated
statements of operations as follows:
Schedule
of Share-based Compensation Expense
| |
2024 | | |
2023 | |
| |
Three
Months Ended December 31, | |
| |
2024 | | |
2023 | |
Research
and development | |
$ | 28,268 | | |
$ | 24,554 | |
General
and administrative | |
| 32,127 | | |
| 25,451 | |
Share-based
compensation | |
$ | 60,395 | | |
$ | 50,005 | |
|
Schedule of Restricted Stock Units Activity |
The
following table summarizes RSU activity under the Plan:
Schedule
of Restricted Stock Units Activity
| |
| | |
Weighted | |
| |
| | |
Average
Grant | |
| |
RSU | | |
Date
Fair Value | |
Unvested
balance at December 31, 2024 | |
| 9,175 | | |
$ | 14.08 | |
|
Schedule of Restricted Stock Awards Activity |
The
following table summarizes RSA activity under the Plan:
Schedule
of Restricted Stock Awards Activity
| |
| | |
Weighted | |
| |
| | |
Average
Grant | |
| |
RSA | | |
Date
Fair Value | |
Unvested
balance at December 31, 2024 | |
| 7,977 | | |
$ | 14.08 | |
|
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v3.25.0.1
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v3.25.0.1
Schedule of Potentially Dilutive Securities Excluded from Computation of Diluted Shares (Details) - shares
|
3 Months Ended |
Dec. 31, 2024 |
Dec. 31, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
5,161,565
|
805,931
|
Common Stock Warrants August 2021 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
14,031
|
14,031
|
Underwriter Warrants August 2021 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
284
|
284
|
Chanticleer Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
6
|
6
|
Series C Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
2,297
|
2,297
|
Series 3 Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
1,566
|
1,566
|
Unvested Restricted Stock Units and Awards [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
17,152
|
976
|
Common Stock Warrants February 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
31,563
|
33,982
|
Underwriter Warrants February 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
1,933
|
1,933
|
Common Stock Private Placement Warrants June 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
28,409
|
28,409
|
Placement Agent Warrants June 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
852
|
852
|
Common Stock Warrants October 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
354,994
|
710,931
|
Underwriter Warrants October 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
10,664
|
10,664
|
Placement Agent Warrants June 2024 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
14,142
|
|
Common Stock Warrants June 2024 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
703,125
|
|
Common Stock Warrants November 2024 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
2,222,222
|
|
Common Stock Registered Direct Warrants December 2024 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
1,085,325
|
|
Common Stock PIPE Warrants December 2024 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
673,000
|
|
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v3.25.0.1
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
12 Months Ended |
|
Nov. 30, 2024 |
Sep. 25, 2024 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Dec. 31, 2023 |
Sep. 30, 2024 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
[custom:IncentiveTaxReceivableCurrent-0] |
|
|
$ 166,792
|
|
|
$ 762,078
|
Cash refund (payment) related to tax incentive program |
|
|
$ 200,000
|
$ 200,000
|
|
|
Proceeds from income tax refunds |
|
|
|
|
$ 800,000
|
|
Reverse stock split description |
|
1-for-8 reverse stock split
|
|
|
|
|
Warrant, shares |
|
|
5,789,600
|
|
|
|
Prefunded October 2023 Warrants [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
99,687
|
192,187
|
192,187
|
|
Exercise price |
|
|
$ 0.0008
|
$ 0.0008
|
$ 0.0008
|
|
Warrant, shares |
|
|
155,125
|
|
|
|
Prefunded December 2024 Warrants [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
545,500
|
|
|
|
Exercise price |
|
|
$ 0.0001
|
|
|
|
Research and Development Tax Incentive Program [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Refund Received Related to Revenue from Different Year, Year Revenue Recognized |
|
|
The
cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian) during the reimbursable
period.
|
|
|
|
[custom:IncentiveTaxReceivableCurrent-0] |
|
|
$ 200,000
|
|
|
|
Proceeds from income tax refunds |
$ 700,000
|
|
|
|
|
|
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v3.25.0.1
Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($)
|
Dec. 31, 2024 |
Sep. 30, 2024 |
Payables and Accruals [Abstract] |
|
|
Compensation and benefits |
$ 155,514
|
$ 149,802
|
Research and development |
969,684
|
617,545
|
Professional fees |
267,587
|
173,319
|
Other |
1,735
|
1,823
|
Accrued expenses and other current liabilities |
$ 1,394,520
|
$ 942,489
|
X |
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v3.25.0.1
Commitments and Contingencies (Details Narrative) € in Millions |
1 Months Ended |
3 Months Ended |
|
|
|
|
Aug. 31, 2024 |
Apr. 30, 2022
USD ($)
|
Dec. 31, 2021
USD ($)
|
Dec. 31, 2024
USD ($)
|
Dec. 31, 2023
USD ($)
|
Dec. 31, 2024
EUR (€)
|
Apr. 30, 2023
USD ($)
|
Jan. 31, 2019
USD ($)
|
Jul. 31, 2012
USD ($)
|
Discovery Collaboration Agreements [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
License fees |
|
|
|
$ 100,000
|
$ 0
|
|
|
|
|
Discovery Collaboration Agreements [Member] | XOMA [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
|
|
|
|
|
$ 3,800,000
|
Discovery Collaboration Agreements [Member] | XOMA [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
License fees |
|
$ 500,000
|
|
0
|
0
|
|
|
|
|
Cellca Agreement [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
$ 600,000
|
|
|
|
|
|
Description of milestone payments |
|
|
|
The Company is obligated to make milestone payments to Cellca totaling up to $0.7 million upon the achievement of certain development
and approval milestones if the Buy-Out Option is not exercised.
|
|
|
|
|
|
Cellca Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
|
|
|
|
$ 700,000
|
|
Payment for annual license fee obligation |
|
|
|
$ 600,000
|
|
|
|
|
|
Cellca Agreement [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Payment for annual license fee obligation |
|
|
|
100,000
|
|
|
|
|
|
Cellca Agreement [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
License fees |
|
|
|
0
|
0
|
|
|
|
|
Commercial product license fee payment obligation |
|
$ 100,000
|
|
|
|
|
|
|
|
The Brink Agreement [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
License fees |
|
|
|
12,000,000,000
|
12,000,000,000
|
|
|
|
|
Commercial product license fee payment obligation |
|
|
|
100,000
|
|
|
|
|
|
[custom:PaymentOfAnnualLicenseFeeObligation-0] |
|
|
|
|
|
|
$ 12,000
|
|
|
The Brink Agreement [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
[custom:DevelopmentLicenseFeePaymentObligation-0] |
|
|
|
100,000
|
|
|
|
|
|
InvivoGen Agreement [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
License fees |
|
|
|
0
|
$ 0
|
|
|
|
|
Payment for annual license fee obligation |
|
|
|
$ 100,000
|
|
€ 0.1
|
|
|
|
SOC Agreement [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Agreements description |
Company establishes
a partnership with a third party prior to the initiation of the initial efficacy combination trial under this collaboration, the Company
will incur, payable to the SOC, a one-time fee equal to the greater of 5% or $1.5 million from the first upfront payment received from
such third party partnership
|
|
|
|
|
|
|
|
|
Navigo Agreement [Member] | Navigo Proteins GmbH [Member] | Technology Service [Member] |
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
$ 1,000,000.0
|
|
|
|
|
|
|
Payments to Acquire in Process Research and Development |
|
|
100,000
|
|
|
|
|
|
|
Evaluation milestone recognized |
|
|
$ 300,000
|
|
|
|
|
|
|
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v3.25.0.1
Collaboration Revenue (Details Narrative) - USD ($)
|
|
3 Months Ended |
|
Oct. 08, 2024 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Sep. 30, 2024 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Performance obligation |
|
$ 1,000,000.0
|
|
|
Collaboration revenue |
|
1,000,000
|
$ 18,626
|
|
Unbilled collaboration revenue |
|
500,000
|
|
|
License Agreement [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Proceeds for negotiate license agreement |
|
1,000,000.0
|
|
|
Alkem Agreement [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Proceeds for negotiate license agreement |
|
1,000,000.0
|
|
|
Collavorative arrangement right and obligation |
Company
granted Alkem an exclusive license (with the right to sublicense) to research, develop, manufacture, import, export, market, use and
commercialize pharmaceutical products containing its IL-6 (SON-080) asset (or any derivatives, fragments or conjugates thereof) (the
“Compounds”) (such products, the “Products”) for the treatment of DPN (the “DPN Field”) and to
manufacture, import, export, market, use and commercialize Products for the treatment of CIPN and autonomic neuropathy (together
with the DPN Field, the “Fields”) in India. Except as provided for in the Alkem Agreement, the Company agreed not to
develop, use, sell, offer or otherwise commercialize any Compounds or Products for use in the DPN Field in India during the term of
the Alkem Agreement. The Company retains all rights to manufacture Compounds and Products anywhere in the world
|
|
|
|
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|
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v3.25.0.1
Schedule of Warrants Outstanding (Details)
|
Dec. 31, 2024
$ / shares
shares
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
5,789,600
|
Common Stock Warrants August 2021 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
14,031
|
Exercise Price | $ / shares |
$ 2,094.4000
|
Expiration Date |
Aug. 24, 2026
|
Underwriter Warrants August 2021 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
284
|
Exercise Price | $ / shares |
$ 2,618.0000
|
Expiration Date |
Aug. 19, 2026
|
Chanticleer Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
6
|
Chanticleer Warrants [Member] | Minimum [Member] |
|
Class of Warrant or Right [Line Items] |
|
Exercise Price | $ / shares |
$ 144,144.0000
|
Expiration Date |
Apr. 30, 2027
|
Chanticleer Warrants [Member] | Maximum [Member] |
|
Class of Warrant or Right [Line Items] |
|
Exercise Price | $ / shares |
$ 224,224.0000
|
Expiration Date |
Dec. 17, 2028
|
Series C Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
2,297
|
Exercise Price | $ / shares |
$ 7,860.1600
|
Expiration Date |
Oct. 16, 2025
|
Series 3 Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
1,566
|
Exercise Price | $ / shares |
$ 717.0240
|
Expiration Date |
Aug. 15, 2027
|
Common Stock Warrants February 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
31,563
|
Exercise Price | $ / shares |
$ 190.0800
|
Expiration Date |
Feb. 10, 2028
|
Underwriter Warrant February 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
1,933
|
Exercise Price | $ / shares |
$ 237.6000
|
Expiration Date |
Feb. 08, 2028
|
Common Stock Private Placement Warrants June 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
28,409
|
Exercise Price | $ / shares |
$ 12.4000
|
Expiration Date |
Jun. 21, 2029
|
Placement Agent Warrants June 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
852
|
Exercise Price | $ / shares |
$ 118.7824
|
Expiration Date |
Dec. 30, 2026
|
Common Stock Warrants October 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
354,994
|
Exercise Price | $ / shares |
$ 9.6000
|
Expiration Date |
Oct. 27, 2028
|
Prefunded Warrants October 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
99,687
|
Exercise Price | $ / shares |
$ 0.0008
|
Underwriter Warrants October 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
10,664
|
Exercise Price | $ / shares |
$ 16.0000
|
Expiration Date |
Oct. 24, 2028
|
Placement Agent Warrants June 2024 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
14,142
|
Exercise Price | $ / shares |
$ 14.8800
|
Expiration Date |
Jun. 19, 2029
|
Common Stock Warrants June 2024 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
703,125
|
Exercise Price | $ / shares |
$ 12.4000
|
Expiration Date |
Jun. 21, 2029
|
Common Stock Warrants November 2024 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
2,222,222
|
Exercise Price | $ / shares |
$ 4.5000
|
Expiration Date |
Nov. 07, 2029
|
Common Stock Registered Direct Warrants December 2024 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
1,085,325
|
Exercise Price | $ / shares |
$ 2.1000
|
Expiration Date |
Dec. 09, 2029
|
Common Stock PIPE Warrants December 2024 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
673,000
|
Exercise Price | $ / shares |
$ 2.1000
|
Expiration Date |
Dec. 09, 2029
|
Pre-funded Warrants December 2024 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants, Outstanding | shares |
545,500
|
Exercise Price | $ / shares |
$ 0.0001
|
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v3.25.0.1
Stockholders’ Equity (Deficit) (Details Narrative) - USD ($)
|
|
|
|
|
3 Months Ended |
|
Dec. 10, 2024 |
Nov. 07, 2024 |
May 02, 2024 |
Oct. 26, 2023 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Jun. 30, 2024 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Proceeds from sale of common stock |
|
|
|
|
$ 7,711,161
|
$ 3,838,870
|
|
Issuance of share, value |
|
|
|
|
$ 7,622,619
|
3,916,943
|
|
Warrant, shares |
|
|
|
|
5,789,600
|
|
|
Purchase and Registration Rights Agreement [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Common stock avialable to be sold |
|
|
|
|
$ 24,900,000
|
|
|
Underwriting Agreement [Member] | Chardan Capital Markets LLC [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Shares for sale |
|
155,000
|
|
|
|
|
|
Proceeds from offering |
|
$ 4,200,000
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Issuance of share, value |
|
|
|
|
$ 105
|
$ 16
|
|
Net share settlement of warrants, shares |
|
|
|
|
1,209
|
1,795
|
|
Sale of common stock, net of issuance costs, shares |
|
|
|
|
1,050,500
|
163,281
|
|
Common Stock [Member] | Purchase and Registration Rights Agreement [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Shares for sale |
|
|
|
|
0
|
|
|
Issuance of share, value |
|
|
$ 25,000,000.0
|
|
|
|
|
Volume weighted average price discount percentage |
|
|
4.00%
|
|
|
|
|
Prefunded Warrant [Member] | Underwriting Agreement [Member] | Chardan Capital Markets LLC [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
956,111
|
|
|
|
|
|
Offering price per share |
|
$ 4.4999
|
|
|
|
|
|
Exercisable price |
|
$ 0.0001
|
|
|
|
|
|
Common Warrant [Member] | Underwriting Agreement [Member] | Chardan Capital Markets LLC [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
2,222,222
|
|
|
|
|
|
Offering price per share |
|
$ 4.50
|
|
|
|
|
|
Exercisable price |
|
$ 4.50
|
|
|
|
|
|
Warrants term |
|
5 years
|
|
|
|
|
|
Common Stock Warrants [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Warrant, shares |
|
|
|
|
32,375
|
|
187,500
|
Net share settlement of warrants, shares |
|
|
|
|
2,419
|
3,590
|
|
Sale of common stock, net of issuance costs, shares |
|
|
|
|
1,209
|
1,795
|
|
Prefunded October 2023 Warrants [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
|
|
99,687
|
192,187
|
|
Exercisable price |
|
|
|
|
$ 0.0008
|
$ 0.0008
|
|
Warrant, shares |
|
|
|
|
155,125
|
|
|
Pre-funded Warrants [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Number of warrant exercised |
|
|
|
|
1,273,436
|
|
|
Holder [Member] | Common Stock Warrants [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Forfeited warrants, shares |
|
|
|
|
|
4,302
|
|
October Offering [Member] | Underwriters [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Proceeds from sale of common stock |
|
|
|
$ 3,900,000
|
|
|
|
Warrants to purchase common stock |
|
|
|
10,664
|
|
|
|
Exercisable price |
|
|
|
$ 16.00
|
|
|
|
Warrants term |
|
|
|
5 years
|
|
|
|
October Offering [Member] | Underwriters [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Shares for sale |
|
|
|
163,281
|
|
|
|
October Offering [Member] | Underwriters [Member] | Prefunded Warrant [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
|
192,187
|
|
|
|
Offering price per share |
|
|
|
$ 12.7992
|
|
|
|
Exercisable price |
|
|
|
$ 0.0008
|
|
|
|
October Offering [Member] | Underwriters [Member] | Common Warrant [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
|
710,931
|
|
|
|
Offering price per share |
|
|
|
$ 12.80
|
|
|
|
Exercisable price |
|
|
|
$ 12.80
|
|
|
|
Warrants term |
|
|
|
5 years
|
|
|
|
October Offering [Member] | Underwriters [Member] | June 2024 Inducement Offer [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Warrants exercise price decrease |
|
|
|
$ 9.60
|
|
|
|
Registered Direct Offering [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Offering price per share |
$ 2.23
|
|
|
|
|
|
|
Proceeds from offering |
$ 3,500,000
|
|
|
|
|
|
|
Registered Direct Offering [Member] | Prefunded Warrant [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Offering price per share |
$ 2.2299
|
|
|
|
|
|
|
Registered Direct Offering [Member] | Prefunded Warrant [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Shares for sale |
768,000
|
|
|
|
|
|
|
Warrants to purchase common stock |
317,325
|
|
|
|
|
|
|
Exercisable price |
$ 0.0001
|
|
|
|
|
|
|
Registered Direct Offering [Member] | Warrant [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Warrants to purchase common stock |
1,085,325
|
|
|
|
|
|
|
Exercisable price |
$ 2.10
|
|
|
|
|
|
|
Warrants term |
5 years
|
|
|
|
|
|
|
Private Placement [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Offering price per share |
$ 2.23
|
|
|
|
|
|
|
Private Placement [Member] | Prefunded Warrant [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Shares for sale |
127,500
|
|
|
|
|
|
|
Warrants to purchase common stock |
545,500
|
|
|
|
|
|
|
Exercisable price |
$ 0.0001
|
|
|
|
|
|
|
Private Placement [Member] | Warrant [Member] |
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
Warrants to purchase common stock |
673,000
|
|
|
|
|
|
|
Exercisable price |
$ 2.10
|
|
|
|
|
|
|
Warrants term |
5 years
|
|
|
|
|
|
|
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v3.25.0.1
Subsequent Events (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
Feb. 12, 2025 |
Jan. 01, 2025 |
Dec. 31, 2024 |
Dec. 31, 2023 |
Subsequent Event [Line Items] |
|
|
|
|
Proceeds from issuance of common stock |
|
|
$ 7,711,161
|
$ 3,838,870
|
Domestic Tax Jurisdiction [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Net operating losses |
|
|
$ 800,000
|
|
Subsequent Event [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Base salary |
$ 330,000
|
|
|
|
Subsequent Event [Member] | Domestic Tax Jurisdiction [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Net operating losses |
|
$ 800,000
|
|
|
Purchase Agreement [Member] | Subsequent Event [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Sale of stock, number of shares issued in transaction |
|
58,270
|
|
|
Proceeds from issuance of common stock |
|
$ 100,000
|
|
|
X |
- DefinitionAmount of operating loss carryforward, before tax effects, available to reduce future taxable income under enacted tax laws.
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