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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

 

    Page No.
     
Part I Financial Information 3
     
Item 1: Financial Statements (unaudited) 3
     
  Consolidated Balance Sheets 4
  Consolidated Statements of Operations 5
  Consolidated Statements of Changes in Stockholders’ Equity (Deficit) 6
  Consolidated Statements of Cash Flows 7
  Notes to Interim Consolidated Financial Statements 8
Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations 22
Item 3: Quantitative and Qualitative Disclosures about Market Risk 36
Item 4: Controls and Procedures 36
     
Part II Other Information 37
     
Item 1: Legal Proceedings 37
Item 1A: Risk Factors 37
Item 2: Unregistered Sales of Equity Securities and Use of Proceeds 37
Item 3: Defaults Upon Senior Securities 37
Item 4: Mine Safety Disclosures 37
Item 5: Other Information 37
Item 6: Exhibits 38
     
Signatures 39

 

2

 

 

SONNET BIOTHERAPEUTICS HOLDINGS, INC.

 

INDEX TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

 

PART I - FINANCIAL INFORMATION

 

Item 1: Financial Statements.

 

  Page
   
Consolidated Balance Sheets 4
Consolidated Statements of Operations 5
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) 6
Consolidated Statements of Cash Flows 7
Notes to Interim Consolidated Financial Statements 8
Management’s Discussion and Analysis of Financial Condition and Results of Operations 22

 

3

 

 

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

 

4

 

 

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 
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 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

 

5

 

 

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)
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 

  

See accompanying notes to unaudited interim consolidated financial statements

 

6

 

 

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

 

7

 

 

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.

 

8

 

 

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.

 

9

 

  

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.

 

10

 


 

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.

 

11

 

 

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.

 

12

 

 

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:

 

   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.

 

13

 

 

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: 

 

   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.

 

14

 

 

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.

 

15

 

 

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.

 

16

 

 

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.

 

17

 

 

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.

 

18

 


 

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.

 

19

 

 

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:

 

   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.

 

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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:

 

   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:

 

       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.

 

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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.

 

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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”).

 

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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.

 

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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.

 

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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.

 

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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.

 

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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;

 

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 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;

 

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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

)

 

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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 

 

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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;

 

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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.

 

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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.

 

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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.

 

35

 

 

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.

 

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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.

 

37

 

  

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.

 

38

 

  

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)

 

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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.

 

-2-

 

 

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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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]

 

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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.

 

 

 

v3.25.0.1
Cover - $ / shares
3 Months Ended
Dec. 31, 2024
Feb. 12, 2025
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Dec. 31, 2024  
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2024  
Current Fiscal Year End Date --09-30  
Entity File Number 001-35570  
Entity Registrant Name SONNET BIOTHERAPEUTICS HOLDINGS, INC.  
Entity Central Index Key 0001106838  
Entity Tax Identification Number 20-2932652  
Entity Incorporation, State or Country Code DE  
Entity Address, Address Line One 100 Overlook Center  
Entity Address, Address Line Two Suite 102  
Entity Address, City or Town Princeton  
Entity Address, State or Province NJ  
Entity Address, Postal Zip Code 08540  
City Area Code (609)  
Local Phone Number 375-2227  
Title of 12(b) Security Common Stock, par value $0.0001 per share  
Trading Symbol SONN  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   3,065,701
Entity Listing, Par Value Per Share $ 0.0001  
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
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
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
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      
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
v3.25.0.1
Pay vs Performance Disclosure - USD ($)
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Pay vs Performance Disclosure [Table]    
Net Income (Loss) $ (3,160,706) $ (1,168,509)
v3.25.0.1
Insider Trading Arrangements
3 Months Ended
Dec. 31, 2024
Insider Trading Arrangements [Line Items]  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
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

 

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:

 

   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

 

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: 

 

   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 

 

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.

 

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.

 

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:

 

   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

 

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:

 

   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:

 

       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.

 

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.

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:

 

   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.

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:

 

   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 
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: 

 

   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 
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:

 

   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           
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:

 

   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:

 

       Weighted 
       Average Grant 
   RSA   Date Fair Value 
Unvested balance at December 31, 2024   7,977   $14.08 
v3.25.0.1
Organization and Description of Business (Details Narrative) - USD ($)
Dec. 31, 2024
Sep. 30, 2024
Income Tax Paid, by Individual Jurisdiction [Line Items]    
Cash $ 4,861,503 $ 149,456
Domestic Tax Jurisdiction [Member]    
Income Tax Paid, by Individual Jurisdiction [Line Items]    
Net operating losses $ 800,000  
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
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          
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
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            
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      
[custom:MilestonePayments-0]   $ 1,000,000.0    
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
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            
v3.25.0.1
Schedule of Share-based Compensation Expense (Details) - USD ($)
3 Months Ended
Dec. 31, 2024
Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Share-based compensation $ 60,395 $ 50,005
Restricted Stock Units (RSUs) [Member] | Research and Development Expense [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Share-based compensation 28,268 24,554
Restricted Stock Units (RSUs) [Member] | General and Administrative Expense [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Share-based compensation $ 32,127 $ 25,451
v3.25.0.1
Schedule of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) [Member]
Dec. 31, 2024
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Unvested balance | shares 9,175
Unvested weighted average grant fair value, balance | $ / shares $ 14.08
v3.25.0.1
Schedule of Restricted Stock Awards Activity (Details) - Restricted Stock Awards (RSA) [Member]
Dec. 31, 2024
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Unvested balance | shares 7,977
Unvested weighted average grant fair value, balance | $ / shares $ 14.08
v3.25.0.1
Share-Based Compensation (Details Narrative) - USD ($)
Jan. 01, 2025
Jan. 01, 2024
Dec. 31, 2024
Restricted Stock Units (RSUs) [Member]      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]      
Number of shares granted   9,175  
Unrecognized compensation expense     $ 0
Restricted Stock Awards (RSA) [Member]      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]      
Number of shares granted   7,977  
Unrecognized compensation expense     $ 0
Subsequent Event [Member]      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]      
Vesting percentage 100.00%    
2020 Omnibus Equity Incentive Plan [Member]      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]      
Number of shares available for issuance     5
2020 Omnibus Equity Incentive Plan [Member] | Subsequent Event [Member]      
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]      
Number of shares available for issuance 120,302    
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    

Sonnet BioTherapeutics (NASDAQ:SONN)
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