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 June 30, 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: 001-39138
JASPER
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
Delaware | | 84-2984849 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
2200 Bridge Pkwy Suite #102 Redwood City, CA | | 94065 |
(Address of principal executive offices) | | (Zip Code) |
(650) 549-1400 |
(Registrant’s telephone number, including area code) |
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Voting Common Stock, par value $0.0001 per share | | JSPR | | The Nasdaq Stock Market LLC |
Redeemable Warrants, each ten warrants exercisable for one share of Voting Common Stock at an exercise price of $115.00 | | JSPRW | | The Nasdaq Stock 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 ☒
As
of August 9, 2024, the number of shares of the registrant’s common stock outstanding was 15,105,300 shares of voting
common stock, $0.0001 par value per share, and no shares of non-voting common stock, $0.0001 par value per share.
JASPER
THERAPEUTICS, INC.
FORM
10-Q FOR THE QUARTERLY PERIOD ENDED
JUNE
30, 2024
TABLE
OF CONTENTS
PART I.
FINANCIAL INFORMATION
Item
1. Financial Statements
JASPER
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except share and per share data)
(unaudited)
| |
June
30, 2024 | | |
December
31, 2023 | |
Assets | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash
equivalents | |
$ | 106,819 | | |
$ | 86,887 | |
Prepaid
expenses and other current assets | |
| 1,861 | | |
| 2,051 | |
Total current assets | |
| 108,680 | | |
| 88,938 | |
Property and equipment, net | |
| 2,438 | | |
| 2,727 | |
Operating lease right-of-use assets | |
| 1,231 | | |
| 1,467 | |
Restricted cash | |
| 417 | | |
| 417 | |
Other non-current assets | |
| 1,163 | | |
| 1,343 | |
Total assets | |
$ | 113,929 | | |
$ | 94,892 | |
Liabilities and Stockholders’
Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 2,964 | | |
$ | 4,149 | |
Current portion of operating
lease liabilities | |
| 1,029 | | |
| 972 | |
Earnout liability | |
| 20 | | |
| — | |
Accrued
expenses and other current liabilities | |
| 6,055 | | |
| 7,253 | |
Total current liabilities | |
| 10,068 | | |
| 12,374 | |
Non-current portion of operating lease liabilities | |
| 1,287 | | |
| 1,814 | |
Other non-current liabilities | |
| 2,264 | | |
| 2,264 | |
Total
liabilities | |
| 13,619 | | |
| 16,452 | |
| |
| | | |
| | |
Commitments and contingencies (Note 8) | |
| | | |
| | |
Stockholders’ equity | |
| | | |
| | |
Preferred stock: $0.0001 par value — 10,000,000 shares authorized at June 30, 2024 and December 31, 2023; none issued and outstanding at June 30, 2024 and December 31, 2023 | |
| — | | |
| — | |
Common stock: $0.0001 par value — 492,000,000 shares authorized at June 30, 2024 and December 31, 2023; 15,105,300 and 11,163,896 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | |
| 2 | | |
| 1 | |
Additional paid-in capital | |
| 298,219 | | |
| 248,039 | |
Accumulated
deficit | |
| (197,911 | ) | |
| (169,600 | ) |
Total
stockholders’ equity | |
| 100,310 | | |
| 78,440 | |
Total liabilities and
stockholders’ equity | |
$ | 113,929 | | |
$ | 94,892 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
JASPER
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in
thousands, except share and per share data)
(unaudited)
| |
Three
Months Ended June 30, | | |
Six
Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating expenses | |
| | |
| | |
| | |
| |
Research
and development | |
$ | 11,296 | | |
$ | 13,297 | | |
$ | 21,594 | | |
$ | 23,102 | |
General
and administrative | |
| 4,697 | | |
| 4,530 | | |
| 9,471 | | |
| 8,672 | |
Total
operating expenses | |
| 15,993 | | |
| 17,827 | | |
| 31,065 | | |
| 31,774 | |
Loss
from operations | |
| (15,993 | ) | |
| (17,827 | ) | |
| (31,065 | ) | |
| (31,774 | ) |
Interest
income | |
| 1,450 | | |
| 1,436 | | |
| 2,836 | | |
| 2,532 | |
Change
in fair value of earnout liability | |
| — | | |
| 420 | | |
| (20 | ) | |
| (344 | ) |
Change
in fair value of common stock warrant liability | |
| — | | |
| — | | |
| — | | |
| (575 | ) |
Other
expense, net | |
| (40 | ) | |
| (109 | ) | |
| (62 | ) | |
| (179 | ) |
Total
other income, net | |
| 1,410 | | |
| 1,747 | | |
| 2,754 | | |
| 1,434 | |
Net
loss and comprehensive loss | |
$ | (14,583 | ) | |
$ | (16,080 | ) | |
$ | (28,311 | ) | |
$ | (30,340 | ) |
Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.97 | ) | |
$ | (1.47 | ) | |
$ | (2.00 | ) | |
$ | (3.08 | ) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | |
| 14,986,367 | | |
| 10,921,239 | | |
| 14,160,634 | | |
| 9,860,392 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
JASPER
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in
thousands, except share data)
(unaudited)
Three
Months Ended June 30, 2024
| |
Common
Stock | | |
Additional
Paid-In | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance
as of March 31, 2024 | |
| 15,085,553 | | |
$ | 2 | | |
$ | 296,556 | | |
$ | (183,328 | ) | |
$ | 113,230 | |
Issuance
of common stock upon exercise of stock options | |
| 8,886 | | |
| — | | |
| 136 | | |
| — | | |
| 136 | |
Issuance
of common stock pursuant to Employee Stock Purchase Plan | |
| 10,861 | | |
| — | | |
| 45 | | |
| — | | |
| 45 | |
Stock-based
compensation expense | |
| — | | |
| — | | |
| 1,482 | | |
| — | | |
| 1,482 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (14,583 | ) | |
| (14,583 | ) |
Balance
as of June 30, 2024 | |
| 15,105,300 | | |
$ | 2 | | |
$ | 298,219 | | |
$ | (197,911 | ) | |
$ | 100,310 | |
Three
Months Ended June 30, 2023
| |
Common
Stock | | |
Additional
Paid-In | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance
as of March 31, 2023 | |
| 10,942,677 | | |
$ | 1 | | |
$ | 244,592 | | |
$ | (119,395 | ) | |
$ | 125,198 | |
Issuance
of common stock upon exercise of stock options | |
| 45,139 | | |
| — | | |
| 320 | | |
| — | | |
| 320 | |
Issuance
of common stock pursuant to Employee Stock Purchase Plan | |
| 6,498 | | |
| — | | |
| 36 | | |
| — | | |
| 36 | |
Settlement
of restricted stock units | |
| 130,875 | | |
| — | | |
| — | | |
| — | | |
| — | |
Shares
withheld for taxes | |
| (45,277 | ) | |
| — | | |
| (661 | ) | |
| — | | |
| (661 | ) |
Vesting
of founders’ restricted stock | |
| — | | |
| — | | |
| 1 | | |
| — | | |
| 1 | |
Stock-based
compensation expense | |
| — | | |
| — | | |
| 1,391 | | |
| — | | |
| 1,391 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (16,080 | ) | |
| (16,080 | ) |
Balance
as of June 30, 2023 | |
| 11,079,912 | | |
$ | 1 | | |
$ | 245,679 | | |
$ | (135,475 | ) | |
$ | 110,205 | |
Six
Months Ended June 30, 2024
| |
Common
Stock | | |
Additional
Paid-In | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance
as of December 31, 2023 | |
| 11,163,896 | | |
$ | 1 | | |
$ | 248,039 | | |
$ | (169,600 | ) | |
$ | 78,440 | |
Issuance
of common stock upon exercise of stock options | |
| 30,543 | | |
| — | | |
| 290 | | |
| — | | |
| 290 | |
Issuance of common stock through underwritten offering, net of discounts and commissions and offering expenses of $3.3 million | |
| 3,900,000 | | |
| 1 | | |
| 47,194 | | |
| — | | |
| 47,195 | |
Issuance
of common stock pursuant to Employee Stock Purchase Plan | |
| 10,861 | | |
| — | | |
| 45 | | |
| — | | |
| 45 | |
Stock-based
compensation expense | |
| — | | |
| — | | |
| 2,651 | | |
| — | | |
| 2,651 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (28,311 | ) | |
| (28,311 | ) |
Balance
as of June 30, 2024 | |
| 15,105,300 | | |
$ | 2 | | |
$ | 298,219 | | |
$ | (197,911 | ) | |
$ | 100,310 | |
Six
Months Ended June 30, 2023
| |
Common
Stock | | |
Additional
Paid-In | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance
as of December 31, 2022 | |
| 3,804,427 | | |
$ | — | | |
$ | 141,124 | | |
$ | (105,135 | ) | |
$ | 35,989 | |
Issuance
of common stock upon exercise of stock options | |
| 49,580 | | |
| — | | |
| 352 | | |
| — | | |
| 352 | |
Issuance of common stock through underwritten offering, net of discounts and commissions and offering expenses of $6.6 million | |
| 6,900,000 | | |
| 1 | | |
| 96,929 | | |
| — | | |
| 96,930 | |
Issuance of common stock through ATM offering, net of commissions and offering expenses of $0.1 million | |
| 233,747 | | |
| — | | |
| 4,509 | | |
| — | | |
| 4,509 | |
Reclassification
of common stock warrants from liability to equity | |
| — | | |
| — | | |
| 725 | | |
| — | | |
| 725 | |
Settlement
of restricted stock units | |
| 130,937 | | |
| — | | |
| — | | |
| — | | |
| — | |
Shares
withheld for taxes | |
| (45,277 | ) | |
| — | | |
| (661 | ) | |
| — | | |
| (661 | ) |
Issuance
of common stock pursuant to Employee Stock Purchase Plan | |
| 6,498 | | |
| — | | |
| 36 | | |
| — | | |
| 36 | |
Vesting
of founders’ restricted stock | |
| — | | |
| — | | |
| 7 | | |
| — | | |
| 7 | |
Stock-based
compensation expense | |
| — | | |
| — | | |
| 2,658 | | |
| — | | |
| 2,658 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (30,340 | ) | |
| (30,340 | ) |
Balance
as of June 30, 2023 | |
| 11,079,912 | | |
$ | 1 | | |
$ | 245,679 | | |
$ | (135,475 | ) | |
$ | 110,205 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
JASPER
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in
thousands)
(unaudited)
| |
Six
Months Ended June
30, | |
| |
2024 | | |
2023 | |
Cash flows used in operating activities | |
| | |
| |
Net loss | |
$ | (28,311 | ) | |
$ | (30,340 | ) |
Adjustments to reconcile net loss to net cash
used in operating activities | |
| | | |
| | |
Depreciation and amortization
expense | |
| 587 | | |
| 549 | |
Non-cash lease expense | |
| 236 | | |
| 201 | |
Stock-based compensation
expense | |
| 2,651 | | |
| 2,658 | |
Change in fair value of
common stock warrant liability | |
| — | | |
| 575 | |
Change in fair value of
earnout liability | |
| 20 | | |
| 344 | |
Changes in operating assets
and liabilities: | |
| | | |
| | |
Prepaid expenses and
other current assets | |
| 190 | | |
| 63 | |
Other receivables | |
| — | | |
| 663 | |
Other non-current assets | |
| 180 | | |
| 314 | |
Accounts payable | |
| (1,301 | ) | |
| (187 | ) |
Accrued expenses and
other current liabilities | |
| (1,198 | ) | |
| 2,002 | |
Operating lease liability | |
| (470 | ) | |
| (417 | ) |
Other
non-current liabilities | |
| — | | |
| (32 | ) |
Net
cash used in operating activities | |
| (27,416 | ) | |
| (23,607 | ) |
Cash flows used in investing
activities | |
| | | |
| | |
Purchases of property
and equipment | |
| (182 | ) | |
| (37 | ) |
Net
cash used in investing activities | |
| (182 | ) | |
| (37 | ) |
Cash flows provided by financing
activities | |
| | | |
| | |
Proceeds from issuance of common stock through
ATM and underwritten offerings, net | |
| 47,195 | | |
| 101,479 | |
Proceeds from issuance of common stock pursuant
to Employee Stock Purchase Plan | |
| 45 | | |
| 36 | |
Taxes withheld and paid related to net share
settlement of equity awards | |
| — | | |
| (661 | ) |
Proceeds from exercise
of common stock options | |
| 290 | | |
| 352 | |
Net
cash provided by financing activities | |
| 47,530 | | |
| 101,206 | |
Net increase in cash, cash equivalents and
restricted cash | |
| 19,932 | | |
| 77,562 | |
Cash, cash equivalents
and restricted cash at beginning of the period | |
| 87,304 | | |
| 38,667 | |
Cash,
cash equivalents and restricted cash at end of the period | |
$ | 107,236 | | |
$ | 116,229 | |
Supplemental and non-cash
items reconciliations: | |
| | | |
| | |
Unpaid
property and equipment included in accounts payable | |
$ | 116 | | |
$ | — | |
Reclassification
of common stock warrant liability into additional paid-in capital | |
$ | — | | |
$ | 725 | |
Unpaid
offerings issuance costs included in accrued expenses and other current liabilities | |
$ | — | | |
$ | 40 | |
Vesting
of founders’ restricted stock | |
$ | — | | |
$ | 7 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
JASPER
THERAPEUTICS, INC.
NOTES
TO UNAUDITED INTERIM CONDENSED
CONSOLIDATED
FINANCIAL STATEMENTS
NOTE
1. ORGANIZATION AND DESCRIPTION OF BUSINESS
Description
of Business
Jasper
Therapeutics, Inc. and its consolidated subsidiary, Jasper Tx Corp. (collectively, “Jasper” or the “Company”),
is a clinical-stage biotechnology company focused on developing therapeutics targeting mast cell driven diseases such as chronic spontaneous
urticaria, chronic inducible urticaria and asthma. The Company also has ongoing programs in diseases where targeting diseased hematopoietic
stem cells can provide benefits, such as lower to intermediate risk myelodysplastic syndrome, and stem cell transplant conditioning regimens.
The
Company is headquartered in Redwood City, California. The Company is a Delaware corporation and was incorporated in March 2018. In September
2021, the Company completed a merger with Amplitude Healthcare Acquisition Corporation and became a public company.
Liquidity
and Going Concern
The
Company has incurred significant losses and negative cash flows from operations since its inception. During the three and six months
ended June 30, 2024, the Company incurred net losses of $14.6 million and $28.3 million, respectively. During the three and
six months ended June 30, 2023, the Company incurred net losses of $16.1 million and $30.3 million, respectively. During the six months
ended June 30, 2024 and 2023, the Company had negative cash flows from operations of $27.4 million and $23.6 million, respectively.
As of June 30, 2024, the Company had an accumulated deficit of $197.9 million. The Company expects to continue to incur substantial
losses, and its ability to achieve and sustain profitability will depend on the successful development, approval, and commercialization
of product candidates and on the achievement of sufficient revenues to support the Company’s cost structure.
As
of June 30, 2024, the Company had cash and cash equivalents of $106.8 million. The Company’s management expects that the existing
cash and cash equivalents will be sufficient to fund the Company’s operating plans for at least twelve months from the issuance
date of these condensed consolidated financial statements. The Company will need to raise additional financing to continue its products’
development for the foreseeable future and expects to continue needing to do so until it becomes profitable. The Company’s management
plans to monitor expenses and raise additional capital through a combination of public and private equity, debt financings, strategic
alliances, and licensing arrangements. The Company’s ability to access capital when needed is not assured and, if capital is not
available to the Company when, and in the amounts needed, the Company may be required to significantly curtail, delay or discontinue
one or more of its research or development programs or the commercialization of any product candidate, or be unable to expand its operations
or otherwise capitalize on the Company’s business opportunities, as desired, which could materially harm the Company’s business,
financial condition and results of operations.
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
condensed consolidated financial statements and accompanying notes are unaudited and have been prepared in accordance with accounting
principles generally accepted in the United States of America (“U.S. GAAP”) and applicable rules and regulations of the U.S.
Securities and Exchange Commission (the “SEC”) regarding interim financial reporting.
The
accompanying condensed financial statements are consolidated and include the accounts of Jasper Therapeutics, Inc. and its wholly-owned
subsidiary, Jasper Tx Corp. All intercompany transactions and balances have been eliminated upon consolidation.
Certain
information and footnote disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed
or omitted pursuant to such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction
with the audited financial statements and the related notes thereto for the year ended December 31, 2023 included in the Company’s
Annual Report on the Form 10-K filed with the SEC on March 5, 2024. The information as of December 31, 2023, included in the condensed
consolidated balance sheets was derived from the Company’s audited financial statements. These unaudited interim condensed consolidated
financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the
opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for a fair statement of the
Company’s consolidated financial statements. The results of operations for the three and six months ended June 30, 2024 are not
necessarily indicative of the results that may be expected for the year ending December 31, 2024 or for any other interim period or for
any other future year.
Reverse
Stock Split
On
January 4, 2024, the Company effected a 1-for-10 reverse stock split (the “Reverse Stock Split”) of its common stock. The
par value per share and the number of authorized shares were not adjusted as a result of the Reverse Stock Split. The shares of common
stock underlying outstanding stock options, common stock warrants and other equity instruments 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 addition, the shares available for grants under the Company’s incentive plans were adjusted as a result of the Reverse Stock
Split. All references to common stock, options to purchase common stock, outstanding common stock warrants, common stock share data,
per share data, and related information contained in the condensed consolidated financial statements have been retrospectively adjusted
to reflect the effect of the Reverse Stock Split for all periods presented.
Use
of Estimates
The
preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions
and judgements that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities as of the date of
the condensed consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant
estimates and assumptions made in the accompanying condensed consolidated financial statements include, but are not limited to, the determination
of the accrued research and development expenses, valuation of earnout liability and the measurement of stock-based compensation expense.
The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those
estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates.
Cash,
Cash Equivalents, and Restricted Cash
The
following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated
balance sheets that sum to the total amount shown in the condensed consolidated statements of cash flows (in thousands):
| |
June
30, 2024 | | |
December 31,
2023 | |
Cash and cash equivalents | |
$ | 106,819 | | |
$ | 86,887 | |
Restricted cash | |
| 417 | | |
| 417 | |
Total
cash, cash equivalents and restricted cash | |
$ | 107,236 | | |
$ | 87,304 | |
Cash
and cash equivalents consist of cash held in operating accounts and investments in money market funds. Restricted cash relates to the
letter of credit secured in conjunction with the operating lease (Note 8).
Concentrations
of Credit Risk and Other Risks and Uncertainties
The
Company’s cash and cash equivalents are maintained with financial institutions in the United States of America. Cash balances
are held at financial institutions and account balances may exceed federally insured limits. To date, the Company has not experienced
any losses on its cash, cash equivalents and marketable securities’ balances and periodically evaluates the creditworthiness of
its financial institutions.
The
Company is subject to risks common to companies in the development stage, including, but not limited to, development and regulatory approval
of new product candidates, development of markets and distribution channels, dependence on key personnel, and the ability to obtain additional
capital as needed to fund its product plans. To achieve profitable operations, the Company must successfully develop and obtain requisite
regulatory approvals for, manufacture, and market its product candidates. There can be no assurance that any such product candidate can
be developed and approved or manufactured at an acceptable cost and with appropriate performance characteristics, or that such product
will be successfully marketed. These factors could have a material adverse effect on the Company’s future financial results.
Products
developed by the Company require approval from the U.S. Food and Drug Administration (“FDA”) or other international
regulatory agencies prior to commercial sales. There can be no assurance that the Company’s future products will receive the necessary
clearances. If the Company were denied such clearances or such clearances were delayed, it could have a materially adverse impact on
the Company.
Stock-Based
Compensation
The
Company measures its stock options granted to employees and non-employees based on the estimated fair values of the awards as of the
grant date using the Black-Scholes option-pricing model. The model requires management to make a number of assumptions, including common
stock fair value, expected volatility, expected term, risk-free interest rate and expected dividend yield. For restricted stock unit
awards, the estimated fair value is the fair market value of the underlying stock on the grant date. The Company expenses the fair value
of its equity-based compensation awards on a straight-line basis over the requisite service period, which is the period in which the
related services are received. The Company accounts for award forfeitures as they occur. The expense for stock-based awards with performance
conditions is recognized when it is probable that a performance condition is met during the vesting period. For performance stock units
that are based on market conditions the estimated fair values of the awards are measured based on Monte Carlo simulation as of the grant
date and is recorded over the vesting period derived from the simulation under the graded-vesting attribution method.
Segment
Reporting
The
Company has determined it operates as a single operating and reportable segment. The Company’s chief operating decision maker,
its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes of allocating resources.
All long-lived assets are located in the United States.
Recent
Accounting Pronouncements Not Yet Adopted
In
November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This ASU requires public entities to disclose
information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public
entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment
disclosures and reconciliation requirements in ASC Topic 280 on an interim and annual basis. ASU No. 2023-07 is effective for fiscal
years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption
permitted. The Company is currently evaluating the impact the adoption of this standard will have on the disclosures within the Company’s
condensed consolidated financial statements.
In
December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This ASU requires public
entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income
taxes paid disaggregated by jurisdiction. ASU No. 2023-09 is effective for fiscal years beginning after December 15, 2024, with early
adoption permitted. The Company is currently evaluating the impact the adoption of this standard will have on the disclosures within
the Company’s condensed consolidated financial statements.
NOTE
3. FAIR VALUE MEASUREMENTS
The
Company measures certain financial assets and liabilities at fair value on a recurring basis. Fair value is an exit price, representing
the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants.
As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in
pricing an asset or a liability. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for
inputs used in the valuation methodologies in measuring fair value:
| ● | Level
1 – Inputs are unadjusted, quoted prices in active markets for identical assets or
liabilities at the measurement date; |
| ● | Level
2 – Inputs are observable, unadjusted quoted prices in active markets for similar assets
or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in
markets that are not active, or other inputs that are observable or can be corroborated by
observable market data for substantially the full term of the related assets or liabilities;
and |
| ● | Level
3 – Unobservable inputs that are significant to the measurement of the fair value of
the assets or liabilities that are supported by little or no market data. |
In
determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of
unobservable inputs to the extent possible as well as considers counterparty credit risk in its assessment of fair value.
Assets
and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the
fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its
entirety requires management to make judgments and consider factors specific to the asset or liability.
The
fair value of Level 1 securities is determined using quoted prices in active markets for identical assets. Level 1 securities consist
of highly liquid money market funds. In addition, restricted cash collateralized by money market funds is a financial asset measured
at fair value and is a Level 1 financial instrument under the fair value hierarchy.
Financial
assets and liabilities are considered Level 2 when their fair values are determined using inputs that are observable in the market or
can be derived principally from or corroborated by observable market data, such as pricing for similar securities, recently executed
transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using
comparisons to like-kind financial instruments and models that use readily observable market data as their basis. The Company had no
financial instruments classified at Level 2 as of June 30, 2024 and December 31, 2023.
Financial
assets and liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies,
or similar techniques and at least one significant model assumption or input is unobservable. Level 3 liabilities that are measured at
fair value on a recurring basis included earnout liability, which was recognized in connection with the business combination in September
2021.
During
the periods presented, the Company has not changed the manner in which it values liabilities that are measured at estimated fair value
using Level 3 inputs. There were no transfers within the hierarchy during the three and six months ended June 30, 2024 and 2023.
The
following tables set forth the fair value of the Company’s financial assets and liabilities measured on a recurring basis by level
within the fair value hierarchy (in thousands):
| |
June
30, 2024 | |
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Financial assets | |
| | |
| | |
| | |
| |
Money
market funds | |
$ | 105,819 | | |
$ | — | | |
$ | — | | |
$ | 105,819 | |
Total fair value of assets | |
$ | 105,819 | | |
$ | — | | |
$ | — | | |
$ | 105,819 | |
| |
| | | |
| | | |
| | | |
| | |
Financial liabilities | |
| | | |
| | | |
| | | |
| | |
Earnout
liability | |
$ | — | | |
$ | — | | |
$ | 20 | | |
$ | 20 | |
Total fair value of financial
liabilities | |
$ | — | | |
$ | — | | |
$ | 20 | | |
$ | 20 | |
| |
December
31, 2023 | |
| |
Level
1 | | |
Level
2 | | |
Level
3 | | |
Total | |
Financial assets | |
| | |
| | |
| | |
| |
Money
market funds | |
$ | 85,887 | | |
$ | — | | |
$ | — | | |
$ | 85,887 | |
Total fair value of assets | |
$ | 85,887 | | |
$ | — | | |
$ | — | | |
$ | 85,887 | |
| |
| | | |
| | | |
| | | |
| | |
Financial liabilities | |
| | | |
| | | |
| | | |
| | |
Earnout
liability | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
Total fair value of financial
liabilities | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
The
following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial liabilities (in thousands):
| |
Earnout
Liability | |
Fair Value as of December 31,
2022 | |
$ | 18 | |
Change
in the fair value included in other expense | |
| 764 | |
Fair Value as of March 31, 2023 | |
$ | 782 | |
Change
in the fair value included in other income | |
| (420 | ) |
Fair Value as of June
30, 2023 | |
$ | 362 | |
| |
| | |
Fair Value as of December 31, 2023 | |
$ | — | |
Change
in the fair value included in other expense | |
| 20 | |
Fair Value as of March 31, 2024 | |
$ | 20 | |
Change
in the fair value included in other expense | |
| — | |
Fair Value as of June
30, 2024 | |
$ | 20 | |
The
estimated fair value of the earnout liability is determined using a Monte Carlo simulation model, which uses a distribution of potential
outcomes on a monthly basis over the earnout period prioritizing the most reliable information available. The assumptions utilized in
the calculation are based on the achievement of certain stock price milestones, including the Company’s current common stock price,
expected volatility, risk-free rate and expected term. The estimates of fair value are uncertain and changes in any of the estimated
inputs used as of the date of this report could have resulted in significant adjustments to the fair value.
The
following table presents quantitative information about the inputs and valuation methodologies used for the Company’s fair value
measurements classified in Level 3 of the fair value hierarchy at June 30, 2024:
| | Fair value (in thousands) | | | Valuation methodology | | Significant unobservable input |
Earnout liability | | $ | 20 | | | Monte Carlo Simulation | | Common stock price | | $ | 29.36 | |
| | | | | | | | Expected term (in years) | | | 0.23 | |
| | | | | | | | Expected volatility | | | 89.0 | % |
| | | | | | | | Risk-free interest rate | | | 5.25 | % |
As
of December 31, 2023, the fair value of the earnout liability was minimal. The following table presents quantitative information
about the inputs and valuation methodologies used for the Company’s fair value measurements classified in Level 3 of the fair value
hierarchy at December 31, 2023:
| | Fair value (in thousands) | | | Valuation methodology | | Significant unobservable input |
Earnout liability | | $ | — | | | Monte Carlo Simulation | | Common stock price | | $ | 7.89 | |
| | | | | | | | Expected term (in years) | | | 0.73 | |
| | | | | | | | Expected volatility | | | 94.0 | % |
| | | | | | | | Risk-free interest rate | | | 4.92 | % |
NOTE
4. CONDENSED CONSOLIDATED BALANCE SHEET COMPONENTS
Prepaid
expenses and other current assets
The
following table summarizes the details of prepaid expenses and other current assets as of the dates set forth below (in thousands):
| |
June
30, 2024 | | |
December 31,
2023 | |
Research and development prepaid
expenses | |
$ | 575 | | |
$ | 615 | |
Prepaid insurance | |
| 466 | | |
| 877 | |
Payroll tax credit receivable | |
| 250 | | |
| 250 | |
Prepaid travel expenses | |
| 95 | | |
| 14 | |
Other prepaid expenses
and current assets | |
| 475 | | |
| 295 | |
Total | |
$ | 1,861 | | |
$ | 2,051 | |
Property
and equipment, net
The
following table summarizes the details of property and equipment, net as of the dates set forth below (in thousands):
|
|
June
30,
2024 |
|
|
December 31,
2023 |
|
Leasehold improvements |
|
$ |
2,629 |
|
|
$ |
2,477 |
|
Lab equipment |
|
|
2,037 |
|
|
|
1,973 |
|
Office furniture & fixtures |
|
|
522 |
|
|
|
502 |
|
Computer equipment |
|
|
207 |
|
|
|
145 |
|
Capitalized software |
|
|
90 |
|
|
|
90 |
|
Property and equipment, gross |
|
|
5,485 |
|
|
|
5,187 |
|
Less: accumulated depreciation and amortization |
|
|
(3,047 |
) |
|
|
(2,460 |
) |
Property and equipment, net |
|
$ |
2,438 |
|
|
$ |
2,727 |
|
Depreciation
and amortization expense was $0.3 million for each of the three months ended June 30, 2024 and 2023, and $0.6 million and $0.5 million
for the six months ended June 30, 2024 and 2023, respectively.
Accrued
expenses and other current liabilities
The
following table summarizes the details of accrued expenses and other current liabilities as of the dates set forth below (in thousands):
| |
June
30, 2024 | | |
December 31,
2023 | |
Research and development accrued
expenses | |
$ | 3,998 | | |
$ | 5,169 | |
Accrued employee and related compensation expenses | |
| 1,610 | | |
| 1,767 | |
Other | |
| 447 | | |
| 317 | |
Total | |
$ | 6,055 | | |
$ | 7,253 | |
Other
non-current liabilities
The
following table summarizes the details of other non-current liabilities as of the dates set forth below (in thousands):
| |
June
30, 2024 | | |
December 31,
2023 | |
CIRM grant
liability | |
$ | 2,264 | | |
$ | 2,264 | |
Total | |
$ | 2,264 | | |
$ | 2,264 | |
NOTE
5. CIRM GRANT
In
November 2020, California Institute for Regenerative Medicine (“CIRM”) awarded the Company $2.3 million in support of
the research project related to a monoclonal antibody that depletes blood stem cells and enables chemotherapy-free transplants. The award
is payable to the Company upon achievement of milestones that are primarily based on patient enrollment in the Company’s clinical
trials. CIRM could permanently cease disbursements if milestones are not met within four months of the scheduled completion date. Additionally,
if CIRM determines, in its sole discretion, that the Company has not complied with the terms and conditions of the grant, CIRM may suspend
or permanently cease disbursements. Funds received under this grant may only be used for allowable project costs specifically identified
with the CIRM-funded project. Such costs can include, but are not limited to, salary for personnel, itemized supplies, consultants, and
itemized clinical study costs. Under the terms of the grant, both CIRM and the Company will co-fund the research project and the amount
of the Company’s co-funding requirement is predetermined as a part of the award. Under the terms of the CIRM grant, the Company
is obligated to pay royalties and licensing fees based on 0.1% of net sales of CIRM-funded product candidates or CIRM-funded technology
per $1.0 million of CIRM grant. As an alternative to revenue sharing, the Company has the option to convert the award to a loan.
In the event the Company exercises its right to convert the award to a loan, it would be obligated to repay the loan within ten business
days of making such election. Repayment amounts vary dependent on when the award is converted to a loan, ranging from 60% of the
award granted to amounts received plus interest at the rate of the three-month LIBOR rate plus 25% per annum. Since the Company
may be required to repay some or all of the amounts awarded by CIRM, the Company accounted for this award as a liability. Given the uncertainty
in amounts due upon repayment, the Company has recorded amounts received without any discount or interest recorded, and upon determination
of amounts that would become due, the Company will adjust accordingly. In the absence of explicit U.S. GAAP guidance on contributions
received by business entities from government entities, the Company has applied to the CIRM grant the recognition and measurement guidance
in Accounting Standards Codification Topic 958-605 by analogy. The Company has received an aggregate of $2.3 million from CIRM through
June 30, 2024, of which $0.7 million was received during the year ended December 31, 2023. As of June 30, 2024, $50,000 is
available for future distribution to the Company under the grant upon the achievement of a future milestone.
NOTE
6. SIGNIFICANT AGREEMENTS
Amgen
License Agreement
In
November 2019, the Company entered into a worldwide exclusive license agreement with Amgen Inc. (“Amgen”) for briquilimab
(formerly known as AMG-191 and JSP191) that also includes translational science and materials from The Board of Trustees of the Leland
Stanford Junior University (“Stanford”) (the “Amgen License Agreement”). The Company was assigned and accepted
Amgen’s rights and obligations, effective November 21, 2019, under the Investigator Sponsored Research Agreement (the “ISRA”),
entered into in June 2013, between Amgen and Stanford, and the Quality Agreement between Amgen and Stanford, effective as of October
7, 2015. Under the ISRA, the Company exercised its option and entered into a definitive license with Stanford for rights to certain Stanford
intellectual property related to the study of briquilimab (see Stanford License Agreement below).
The
Amgen License Agreement terminates on a country-by-country basis on the 10th anniversary of the date on which the exploitation of the
licensed products is no longer covered by a valid claim under a licensed patent in such country. On a country-by-country basis, upon
the expiration of the term in each country with respect to the licensed products, the licenses to the Company by Amgen become fully paid
and non-exclusive. The Company and Amgen have the right to terminate the agreement for a material breach as specified in the agreement.
Stanford
License Agreement
In
March 2021, the Company entered into an exclusive license agreement with Stanford (the “Stanford License Agreement”). In
July 2023, the Company entered into an amendment to the Stanford License Agreement to modify certain milestones set forth thereunder.
The Company received a worldwide, exclusive license, with a right to sublicense, for briquilimab in the field of depleting endogenous
blood stem cells in patients for whom hematopoietic cell transplantation is indicated. Stanford transferred to the Company certain know-how
and patents related to briquilimab (together, the “Licensed Technology”). Under the terms of this agreement, the Company
is required to use commercially reasonable efforts to develop, manufacture, and sell licensed product and to develop markets for a licensed
product. In addition, the Company is required to use commercially reasonable efforts to meet the milestones as specified in the agreement
over the six years from execution of the Stanford License Agreement and must notify Stanford in writing as each milestone is met.
The
Company is obligated to pay annual license maintenance fees, beginning on the first anniversary of the effective date of the agreement
and ending upon the first commercial sale of a product, method, or service in the licensed field of use, as follows: $25,000 for
each first and second year, $35,000 for each third and fourth year and $50,000 at each anniversary thereafter ending upon the
first commercial sale. The Company is also obligated to pay late-stage clinical development milestone payments and first commercial sales
milestone payments of up to $9.0 million in total. The Company will also pay low single-digit royalties on net sales of licensed
products, if approved. The Company paid $35,000 and $25,000 license maintenance fee in March 2024 and 2023, respectively, which
was recognized as research and development expense in the condensed consolidated statements of operations and comprehensive loss for
the six months ended June 30, 2024 and 2023.
The
Stanford License Agreement expires on a country-by-country basis on the last-to-expire valid claim of a licensed patent in such country.
The Company may terminate the agreement by giving Stanford written notice at least 12 months in advance of the effective date of termination.
The Company may also terminate the agreement solely with respect to any particular patent application or patent by giving Stanford written
notice at least 60 days in advance of the effective date of termination. Stanford may terminate the agreement after 90 days from a written
notice by Stanford, specifying a problem, including a delinquency on any report required pursuant to the agreement or any payment, missing
a milestone or a material breach, unless the Company remediates the problem in that 90-day period.
NOTE
7. DERIVATIVE FINANCIAL INSTRUMENTS
Contingent
Earnout Liability
Upon
the closing of the business combination and pursuant to the Sponsor Support Agreement, dated May 5, 2021 and amended on September
24, 2021, by and among the Company, Amplitude Healthcare Holdings LLC (the “Sponsor”) and Jasper Tx Corp., the Sponsor
agreed to place the 105,000 earnout shares into escrow (the “Earnout Shares”), which will be released as follows: (a) 25,000
Earnout Shares will be released if, during the period from and after September 24, 2021 until September 24, 2024 (the “Earnout
Period”), over any twenty trading days within any thirty day consecutive trading day period, the volume-weighted average price
of the Company’s common stock (the “Applicable VWAP”) is greater than or equal to $115.00, (b) 50,000 Earnout Shares
will be released if, during the Earnout Period, the Applicable VWAP is greater than or equal to $150.00 and (c) 30,000 Earnout Shares
will be released if, during the Earnout Period, the Applicable VWAP is greater than or equal to $180.00 (the “triggering events”).
The
Earnout Shares placed in escrow are legally issued and outstanding shares that participate in voting and dividends. The Earnout Shares
(along with related escrowed dividends, if any) will be forfeited and not released from escrow at the end of the Earnout Period unless
the triggering events described above are achieved during the Earnout Period. Upon the closing of the business combination, the contingent
obligation to release the Earnout Shares was accounted for as a liability-classified financial instrument upon their initial recognition
because the triggering events that determine the number of shares required to be released from escrow include events that were not solely
indexed to the common stock of the Company. The earnout liability is remeasured each reporting period with changes in fair value recognized
in earnings.
The
estimated fair value of the earnout liability was less than $0.1 million as of June 30, 2024 and was minimal as of December 31,
2023. The fair value is estimated at the end of each reporting period using a Monte Carlo simulation model. Assumptions used in the valuations
as of June 30, 2024 and December 31, 2023 are described in Note 3. No triggering event occurred as of each of June 30, 2024 and December
31, 2023. The Company recognized no loss or gain and a loss of less than $0.1 million for the three and six months ended June 30,
2024, respectively, and a gain of $0.4 million and a loss of $0.3 million for the three and six months ended June 30, 2023, respectively,
classified within change in fair value of earnout liability in the condensed consolidated statements of operations and comprehensive
loss.
NOTE
8. COMMITMENTS AND CONTINGENCIES
Operating
Leases
As
of June 30, 2024, the Company leased approximately 13,400 square feet of laboratory and office space in Redwood City, California,
under an operating lease that expires in August 2026.
In
conjunction with signing the lease, the Company secured a letter of credit in favor of the lessor in the amount of $0.4 million.
The funds related to this letter of credit are presented as restricted cash on the Company’s condensed consolidated balance sheets.
The lease agreement includes an escalation clause for increased base rent and a renewal provision allowing the Company to extend this
lease for an additional 60 months at the prevailing rental rate, which the Company is not reasonably certain to exercise. In addition
to base rent, the Company pays its share of operating expenses and taxes.
The
components of lease costs, which were included in the Company’s condensed consolidated statements of operations and comprehensive
loss, are as follows (in thousands):
| |
Six
Months Ended June 30, | |
| |
2024 | | |
2023 | |
Lease cost | |
| | |
| |
Operating lease cost | |
$ | 336 | | |
$ | 336 | |
Short-term lease cost | |
| 1 | | |
| 1 | |
Total
lease cost | |
$ | 337 | | |
$ | 337 | |
Supplemental
information related to the Company’s operating leases is as follows:
| | Six Months Ended June 30, | |
| | 2024 | | | 2023 | |
| | | | | | |
Cash paid for amounts included in the measurement of lease liabilities (in thousands) | | $ | 569 | | | $ | 553 | |
Weighted average remaining lease term (years) | | | 2.11 | | | | 3.11 | |
Weighted average discount rate | | | 8.00 | % | | | 8.00 | % |
The
following table summarizes a maturity analysis of the Company’s operating lease liabilities showing the aggregate lease payments
as of June 30, 2024 (in thousands):
| |
Amount | |
Year ending December 31, | |
| |
2024 (remainder of the year) | |
$ | 583 | |
2025 | |
| 1,187 | |
2026 | |
| 740 | |
Total undiscounted lease
payments | |
| 2,510 | |
Less imputed interest | |
| (194 | ) |
Total discounted lease payments | |
| 2,316 | |
Less current portion
of lease liability | |
| (1,029 | ) |
Noncurrent
portion of lease liability | |
$ | 1,287 | |
Stanford
Sponsored Research Agreement
In
September 2020, the Company entered into a sponsored research agreement with Stanford for a research program related to the treatment
of Fanconi Anemia patients in Bone Marrow Failure requiring allogeneic transplant with non-sibling donors at Stanford Lucile Packard
Children’s Hospital using briquilimab (the “Research Project”). Stanford will perform the Research Project and is fully
responsible for costs and operations related to the Research Project. In addition, Stanford owns the entire right, title, and interest
in and to all technology developed using Stanford facilities and by Stanford personnel through the performance of the Research Project
under this agreement (the “Fanconi Anemia Research Project IP”). Under this agreement, Stanford granted the Company an exclusive
option to license Stanford’s rights in the Fanconi Anemia Research Project IP (the “Fanconi Anemia Option”) in the
field of commercialization of briquilimab. There is no license granted or other intellectual property transferred under this agreement
until the Fanconi Anemia Option is exercised. As of June 30, 2024, the Company has not yet exercised the Fanconi Anemia Option.
As
consideration for the services performed by Stanford under this sponsored research agreement, the Company agreed to pay Stanford a total
of $0.9 million over approximately three years upon the achievement of development and clinical milestones, including
the FDA filings and patient enrollment. The first milestone in the amount of $0.3 million was achieved in 2020, the second milestone
in the amount of $0.3 million was achieved in February 2022 and the third and final milestone in the amount of $0.3 million
was achieved in July 2023. Each milestone was recognized as a research and development expense in the condensed consolidated statements
of operations and comprehensive loss in the period in which the milestone was achieved.
License
Agreements
In
March 2021, the Company entered into the Stanford License Agreement (Note 6), which was amended in July 2023, pursuant to which the Company
is required to pay annual license maintenance fees, clinical development and commercial sales milestone payments of up to an aggregate
of $9.0 million, and low single-digit royalties on net sales of licensed products. All products were in development as of June 30,
2024, and no royalties were due as of such date. The Company paid $35,000 and $25,000 license maintenance fee in March 2024
and 2023, respectively, and recognized this as a research and development expense in the condensed consolidated statements of operations
and comprehensive loss for the six months ended June 30, 2024 and 2023, respectively. No expenses were recognized for each of the three
months ended June 30, 2024 and 2023. As of June 30, 2024 and December 31, 2023, no milestones were probable to be achieved and payable.
Legal
Proceedings
The
Company, from time to time, may be party to litigation arising in the ordinary course of business. The Company was not subject to any
material legal proceedings during the six months ended June 30, 2024 and 2023, and, to the best of its knowledge, no material legal proceedings
are currently pending.
Guarantees
and Indemnifications
In
the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification.
The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the
future. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations.
As of June 30, 2024 and December 31, 2023, the Company did not have any material indemnification claims that were probable or reasonably
possible and consequently has not recorded related liabilities.
NOTE
9. COMMON STOCK
The
Company is authorized to issue 490,000,000 shares of voting common stock, 2,000,000 shares of non-voting common
stock, and 10,000,000 shares of undesignated preferred stock. There were 15,105,300 shares of voting common stock, no shares
of non-voting common stock and no shares of preferred stock issued and outstanding as of June 30, 2024.
Holders
of the voting common stock and the non-voting common stock have similar rights, except that non-voting stockholders are not entitled
to vote, including for the election of directors. Holders of voting common stock do not have conversion rights, while holders of non-voting common
stock have the right to convert each share of non-voting common stock held by such holder into one share of voting common stock
at such holder’s election by providing written notice to the Company, provided that as a result of such conversion, such holder,
together with its affiliates, would not beneficially own in excess of 9.9% of the Company’s voting common stock following
such conversion. On January 31, 2023, 91,102 shares of the Company’s non-voting common stock were fully converted into 91,102 shares
of the voting common stock per the holder’s request, and no shares of non-voting common stock remained outstanding after such conversion.
As
of June 30, 2024 and December 31, 2023, the Company had common stock reserved for future issuance as follows:
| |
June
30, 2024 | | |
December 31,
2023 | |
Outstanding and issued common stock
options | |
| 1,543,752 | | |
| 1,040,875 | |
Shares issuable upon exercise of common stock
warrants | |
| 499,986 | | |
| 499,986 | |
Shares available for grant under Equity Incentive
Plans | |
| 1,880,221 | | |
| 119,014 | |
Shares available for grant under Employee Stock
Purchase Plans | |
| 1,000,000 | | |
| 111,958 | |
Shares available for
grant under 2022 Inducement Equity Incentive Plan | |
| 15,885 | | |
| 95,685 | |
Total
shares of common stock reserved | |
| 4,939,844 | | |
| 1,867,518 | |
Shelf
Registration Statement
On
October 7, 2022, the Company filed a shelf registration statement on Form S-3 (the “Prior S-3”) with the Securities and Exchange
Commission (the “SEC”), which was declared effective on October 18, 2022. The Company could sell from time to time up to
$150.0 million of common stock, preferred stock, debt securities, warrants, rights, units or depositary shares comprised of any
combination of these securities, for the Company’s own account in one or more offerings under the Prior S-3. On April 28, 2023,
the Company filed a new shelf registration statement on Form S-3 (“New S-3”) with the SEC, which was declared effective on
May 5, 2023 and superseded the Prior S-3. As of June 30, 2024, the Company can sell from time to time up to $250.0 million of common
stock, preferred stock, debt securities, warrants, rights, units or depositary shares comprised of any combination of these securities,
for the Company’s own account in one or more offerings under the New S-3. The terms of any offering under the New S-3 will be established
at the time of such offering and will be described in a prospectus supplement to the New S-3 filed with the SEC prior to the completion
of any such offering.
ATM
Offering
In
November 2022, the Company entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co.
(the “Agent”), pursuant to which the Company may offer and sell through or to the Agent, as sales agent or principal, shares
of the Company’s common stock from time to time (the “ATM Offering”). On November 10, 2022, the Company filed with
the SEC a prospectus supplement under the Prior S-3 in connection with the ATM Offering, pursuant to which the Company could offer and
sell shares of common stock having an aggregate offering price of up to $15.5 million. In January 2023, the Company issued and sold
an aggregate of 233,747 shares of common stock for net proceeds of $4.5 million.
On
May 5, 2023, the Company filed with the SEC a prospectus under the New S-3 in connection with the ATM Offering (the “ATM Prospectus”),
pursuant to which the Company can now offer and sell shares of common stock having an aggregate offering price of up to $75.0 million.
As
of June 30, 2024, $75.0 million remained available under the ATM Prospectus.
Public
Offering
In
January 2023, the Company entered into an underwriting agreement with Credit Suisse Securities (USA) LLC, William Blair & Company,
L.L.C. and Oppenheimer & Co. Inc., as the representatives of the several underwriters named therein (the “2023 Underwriters”),
relating to an underwritten public offering under the Prior S-3 of 6,900,000 shares of common stock, including 900,000 shares
issued as a result of the exercise of the 2023 Underwriters’ option to purchase 900,000 shares. The Company received
net proceeds of $96.9 million.
Underwritten
Offering
In
February 2024, the Company entered into an underwriting agreement with Cowen and Company, LLC and Evercore Group L.L.C., as the representatives
of the several underwriters named therein, related to an underwritten offering under the New S-3 of 3,900,000 shares of common
stock. The Company received net proceeds of $47.2 million.
As
of June 30, 2024, $124.5 million remained available and unallocated under the New S-3.
NOTE
10. STOCK-BASED COMPENSATION
On
June 6, 2024, the Company’s 2024 Equity Incentive Plan (“2024 Plan”) and the 2024 Employee Stock Purchase Plan (“2024
ESPP”) were approved by its stockholders and became effective, superseding and replacing the Company’s 2021 Equity Incentive
Plan (the “2021 Plan”) and the 2021 Employee Stock Purchase Plan (the “2021 ESPP”), respectively. No further
awards or purchase rights will be granted under the 2021 Plan or the 2021 ESPP.
Under
the 2024 Plan, the Company can grant incentive stock options, nonstatutory stock options, restricted stock awards, stock appreciation
rights, restricted stock units (“RSUs”), performance restricted stock units (“PSUs”), and other stock-based awards
to employees, directors, and consultants. Under the 2024 ESPP, the Company can grant purchase rights to employees to purchase shares
of common stock at a purchase price which is equal to 85% of the fair market value of common stock on the offering date or on the
exercise date, whichever is lower.
On
March 14, 2022, the 2022 Inducement Equity Incentive Plan became effective and it was amended on June 2, 2023 to increase the maximum
number of shares available for grant thereunder (as amended, the “2022 Inducement Plan”). Under the 2022 Inducement Plan,
the Company may grant nonstatutory stock options, restricted stock awards, stock appreciation rights, RSUs, performance awards and other
awards, but only to an individual, as a material inducement to such individual to enter into employment with the Company or an affiliate
of the Company, who (i) has not previously been an employee or director of the Company or (ii) is rehired following a bona fide period
of non-employment with the Company.
Stock
options under the 2024 Plan and the 2022 Inducement Plan may be granted for periods of up to 10 years and at prices no less than 100%
of the fair market value of the shares on the date of grant, provided, however, that the exercise price of an incentive stock option
(which cannot be granted pursuant to the 2022 Inducement Plan) granted to a 10% stockholder may not be less than 110% of the
fair market value of the shares. Stock options granted to employees and non-employees generally vest ratably over four years.
As
of June 30, 2024, 2,764,111 shares were reserved for issuance under the 2024 Plan, of which 1,880,221 shares were
available for future grant and 883,890 shares were subject to outstanding awards including performance-based awards. As of
June 30, 2024, 29,802 shares have been issued under the 2021 ESPP and 1,000,000 shares were reserved and available
for future issuance under the 2024 ESPP. As of June 30, 2024, 550,000 shares were reserved for issuance under the 2022 Inducement
Plan, of which 15,885 shares were available for future grant and 534,115 shares were subject to outstanding stock
options.
Stock
Option Activity
The
following table summarizes the stock option activities, including performance-based stock options, under the 2024 Plan, 2021 Plan, the
2022 Inducement Plan and the Company’s 2019 Equity Incentive Plan for the six months ended June 30, 2024:
| | Options Outstanding | | | Weighted Average Exercise Price | | | Weighted Average Remaining Contractual Life (Years) | | | Aggregate Intrinsic Value (in thousands) | |
Balance, December 31, 2023 | | | 1,040,875 | | | $ | 19.82 | | | | 8.55 | | | $ | 237 | |
Options granted | | | 590,517 | | | $ | 19.69 | | | | | | | | | |
Options exercised | | | (30,543 | ) | | $ | 9.52 | | | | | | | | | |
Options cancelled/forfeited | | | (57,097 | ) | | $ | 25.59 | | | | | | | | | |
Balance, June 30, 2024 | | | 1,543,752 | | | $ | 19.76 | | | | 8.63 | | | $ | 8,091 | |
Vested and expected to vest, June 30, 2024 | | | 1,543,752 | | | $ | 19.76 | | | | 8.63 | | | $ | 8,091 | |
Exercisable, June 30, 2024 | | | 452,181 | | | $ | 20.88 | | | | 7.27 | | | $ | 2,840 | |
The
aggregate intrinsic value represents the difference between the estimated fair value of the underlying common stock and the exercise
price of outstanding, in-the-money options. The total intrinsic value of the options exercised during the three and six months ended
June 30, 2024 was $0.1 million and $0.5 million, respectively, and during each of the three and six months ended June 30, 2023 was $0.4
million.
The
total fair value of options that vested during the six months ended June 30, 2024 and 2023 was $3.2 million and $2.1 million,
respectively. The weighted-average grant date fair value of options granted during the six months ended June 30, 2024 and 2023 was $16.88 and
$14.45 per share, respectively.
Unrecognized
stock-based compensation for stock options as of June 30, 2024 was $16.0 million, which is expected to be recognized over a weighted-average
period of 3.0 years, including less than $0.1 million related to performance-based stock options, which is expected to
be recognized over a weighted-average period of 0.5 years.
Performance-Based
Stock Options
The
following table summarizes the performance-based stock options activity under the 2024 Plan and 2021 Plan for the six months ended June
30, 2024:
| | Options Outstanding | | | Weighted Average Exercise Price | | | Weighted Average Remaining Contractual Life (Years) | | | Aggregate Intrinsic Value (in thousands) | |
Balance, December 31, 2023 | | | 46,394 | | | $ | 14.19 | | | | 7.06 | | | $ | 24 | |
Options granted | | | — | | | $ | | | | | | | | | | |
Options cancelled/forfeited | | | — | | | $ | | | | | | | | | | |
Balance, June 30, 2024 | | | 46,394 | | | $ | 14.19 | | | | 6.56 | | | $ | 478 | |
Vested and expected to vest, June 30, 2024 | | | 46,394 | | | $ | 14.19 | | | | 6.56 | | | $ | 478 | |
Exercisable, June 30, 2024 | | | 31,393 | | | $ | 7.78 | | | | 5.96 | | | $ | 478 | |
Restricted
Stock Units (RSUs)
As
of December 31, 2023 the Company had no unvested outstanding RSUs and no RSUs were granted during the six months ended June 30, 2024.
Performance
Restricted Stock Units (PSUs)
The
following table provides a summary of PSU activity under the 2024 Plan during the six months ended June 30, 2024:
| |
Number
of Share | | |
Weighted-
Average Grant Date Fair Value | |
Unvested performance-based restricted stock
units at December 31, 2023 | |
| — | | |
$ | — | |
Granted | |
| 20,000 | | |
$ | 21.90 | |
Unvested performance-based
restricted stock units at June 30, 2024 | |
| 20,000 | | |
$ | 21.90 | |
Outstanding performance-based
restricted stock units at June 30, 2024 | |
| 20,000 | | |
$ | 21.90 | |
In
June 2024, the Company granted PSUs for 20,000 shares that will vest in full if the closing price of the Company’s common stock
on the Nasdaq Capital Market reaches or exceeds $35.00 per share (subject to adjustment for recapitalizations, stock splits and similar
transactions) for thirty consecutive calendar days within two years from the grant date. If the vesting condition is not met within two
years from the grant date, the PSUs will be forfeited. The Company concluded that issued PSUs are equity-based awards and include a market
based vesting condition. The Company used a Monte Carlo simulation model to estimate the fair value of the PSUs with the following assumptions:
common stock fair value of $23.95, which was the closing market price of the Company’s common stock at the grant date, volatility
of 133.00%, risk free rate of 4.87%, vesting term of 2.0 years. Total estimated fair value of $0.4 million is recognized as stock-based
compensation expense over the 0.4 years, the implied requisite service period from the grant date.
Employee
Stock Purchase Plan
The
Company issued 10,861 shares and 6,498 shares of common stock under the 2021 ESPP during the three and six months ended June 30,
2024 and 2023, respectively and recognized less than $0.1 million compensation expense related to the 2021 ESPP during each of the
three and six months ended June 30, 2024 and 2023. The Company did not issue any shares of common stock under the 2024 ESPP during the
three and six months ended June 30, 2024 and 2023 and did not recognize any compensation expense related to the 2024 ESPP during each
of the three and six months ended June 30, 2024 and 2023. There was no unamortized stock-based compensation for shares issuable under
the 2021 ESPP and 2024 ESPP as of June 30, 2024. The Company did not record any accrued expenses and other current liabilities related
to contributions withheld as of June 30, 2024.
Stock-Based
Compensation Expense
The
following table presents stock-based compensation expenses related to options, PSUs and RSUs granted to employees and non-employees,
employee stock purchase plan awards and restricted common stock shares issued to founders (in thousands):
| |
Three
Months Ended June 30, | | |
Six
Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
General and administrative | |
$ | 1,009 | | |
$ | 900 | | |
$ | 1,829 | | |
$ | 1,699 | |
Research and development | |
| 473 | | |
| 491 | | |
| 822 | | |
| 959 | |
| |
$ | 1,482 | | |
$ | 1,391 | | |
$ | 2,651 | | |
$ | 2,658 | |
The
Company recognized less than $0.1 million of stock-based compensation expense related to performance-based options, PSUs and RSUs
during each of the three and six months ended June 30, 2024 and 2023.
Valuation
of Stock Options
The
grant date fair value of stock options was estimated using a Black-Scholes option-pricing model with the following assumptions:
| |
Three Months Ended June 30, | |
Six Months Ended June 30, |
| |
2024 | |
2023 | |
2024 | |
2023 |
Expected term (in years) | |
5.50-6.08 | |
5.44-6.08 | |
5.50-6.08 | |
5.25-6.08 |
Expected volatility | |
116.56%-117.93% | |
103.31%-108.98% | |
112.09%-117.93% | |
103.31%-108.98% |
Risk-free interest rate | |
4.23%-4.50% | |
3.49% - 4.05% | |
3.93%-4.50% | |
3.45% - 4.25% |
Expected dividend yield | |
— | |
— | |
— | |
— |
Valuation
of Employee Stock Purchase Plan Awards
No
2021 ESPP and 2024 ESPP awards were granted during the three and six months ended June 30, 2024. The grant date fair value of 2021 ESPP
awards granted during the three and six months ended June 30, 2023 was estimated using a Black-Scholes option-pricing model with the
following assumptions:
| | Three and Six Months Ended June 30, | |
| | 2024 | | | 2023 | |
Expected term (in years) | | | — | | | | 0.5 | |
Expected volatility | | | — | | | | 266.24 | % |
Risk-free interest rate | | | — | | | | 5.39 | % |
Expected dividend yield | | | — | | | | — | |
NOTE
11. NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS
The
following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands,
except share and per share data):
| |
Three
Months Ended June 30, | | |
Six
Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Numerator: | |
| | |
| | |
| | |
| |
Net
loss attributable to common stockholders | |
$ | (14,583 | ) | |
$ | (16,080 | ) | |
$ | (28,311 | ) | |
$ | (30,340 | ) |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted average
common shares outstanding | |
| 15,091,367 | | |
| 11,034,035 | | |
| 14,265,634 | | |
| 9,977,404 | |
Less:
Weighted-average unvested restricted shares | |
| — | | |
| (7,796 | ) | |
| — | | |
| (12,012 | ) |
Less:
Shares subject to earnout | |
| (105,000 | ) | |
| (105,000 | ) | |
| (105,000 | ) | |
| (105,000 | ) |
Weighted average shares used to compute basic and diluted net loss per share | |
| 14,986,367 | | |
| 10,921,239 | | |
| 14,160,634 | | |
| 9,860,392 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share attributable to common stockholders – basic and diluted | |
$ | (0.97 | ) | |
$ | (1.47 | ) | |
$ | (2.00 | ) | |
$ | (3.08 | ) |
The
potential shares of common stock that were excluded from the computation of diluted net loss per share attributable to common stockholders
for the periods presented because including them would have had an antidilutive effect were as follows:
| |
Three
Months Ended June 30, | | |
Six
Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Outstanding and issued common stock
options | |
| 1,543,752 | | |
| 934,512 | | |
| 1,543,752 | | |
| 934,512 | |
Shares issuable upon exercise of common stock
warrants | |
| 499,986 | | |
| 499,986 | | |
| 499,986 | | |
| 499,986 | |
Unvested performance-based restricted stock
units | |
| 20,000 | | |
| — | | |
| 20,000 | | |
| — | |
Unvested restricted common stock | |
| — | | |
| 5,882 | | |
| — | | |
| 5,882 | |
Unvested restricted
stock units | |
| — | | |
| 117,962 | | |
| — | | |
| 117,962 | |
Total | |
| 2,063,738 | | |
| 1,558,342 | | |
| 2,063,738 | | |
| 1,558,342 | |
NOTE
12. RELATED PARTIES
The
Company entered into consulting agreements with two founders, one of whom is also a member of the Company’s Board of Directors
(the “Board”), and each of whom also received founders’ common stock shares for services and assigned patents. The
Company recorded $0.1 million for the founders’ advisory and consulting services performed for each of the three months ended
June 30, 2024 and 2023. The Company recorded $0.1 million for advisory and consulting services performed by Professor Judith Shizuru,
one of the founders of the Company and a member of the Board, for each of the six months ended June 30, 2024 and 2023. These expenses
were recorded as research and development expenses in the condensed consolidated statements of operations and comprehensive loss. The
Company recorded $0.1 million in accounts payable, accrued expenses and other current liabilities related to advisory and consulting
services performed by Dr. Shizuru as of June 30, 2024. Also, the Company’s Licensed Technology from Stanford (see Note 6) was created
in the Stanford laboratory of Dr. Shizuru.
In
the first quarter of 2024, a senior executive of the Company joined the Board of Directors of an information technology service
provider that the Company has historically utilized to support a broad array of the Company’s systems infrastructure as well as
for general information technology support services. For the three and six months ended June 30, 2024, the Company paid that service
provider $0.3 million and $0.9 million, respectively, for various information technology support services.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You
should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated
financial statements and the related notes included in Part I, Item 1 of this Quarterly Report on Form 10-Q (this “Quarterly
Report”) and with the audited consolidated financial statements and the related notes included in our Annual Report on Form 10-K
for the fiscal year ended December 31, 2023 filed with the Securities and Exchange Commission on March 5, 2024. Certain of the information
contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to plans
and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors,
including those factors set forth in the section entitled “Risk Factors”, in Part I - Item 1A of our Annual Report on Form
10-K for the year ended December 31, 2023, filed with the SEC on March 5, 2024, as updated by the factors described under the heading
“Risk Factors” in Part II - Item 1A of this Quarterly Report, our actual results could differ materially from the results
described in or implied by the forward-looking statements contained in the following discussion and analysis. You should carefully
read the section entitled “Risk Factors” to gain an understanding of the important factors that could cause actual results
to differ materially from our forward-looking statements. Please also see “Cautionary Note Regarding Forward-Looking Statements”
below. The events and circumstances reflected in our forward-looking statements may not be achieved or may not occur, and actual results
could differ materially from those described in or implied by the forward-looking statements contained in the following discussion and
analysis. As a result of these risks, you should not place undue reliance on these forward-looking statements. We assume no obligation
to revise or update any forward-looking statements for any reason, except as required by law.
Throughout
this Quarterly Report, unless the context otherwise requires, the terms “Jasper,” “we,” “us” and
“our” in this Quarterly Report refer to Jasper Therapeutics, Inc. and its consolidated subsidiary.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain
statements contained in this Quarterly Report may constitute “forward-looking statements” for purposes of federal securities
laws. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. In addition, any
statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying
assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,”
“continue,” “could,” “estimate,” “expect,” “intends,”
“may,” “might,” “plan,” “possible,” “potential,”
“predict,” “project,” “should,” “will,” “would”
and similar expressions (including the negative of any of the foregoing) may identify forward-looking statements, but the absence
of these words does not mean that a statement is not forward-looking.
Forward-looking statements
in this Quarterly Report may include, for example, but are not limited to, statements about:
| ● | our
or our management team’s expectations, hopes, beliefs, intentions or strategies regarding
the future; |
| ● | our
ability to research, discover and develop additional product candidates; |
| ● | the
success, cost and timing of our product development activities and clinical trials; |
| ● | the
potential attributes and benefits of our product candidates; |
| ● | our
ability to obtain and maintain regulatory approval for our product candidates; |
| ● | our
ability to obtain funding for our operations; |
| ● | our
projected financial information, anticipated growth rate and market opportunity; |
| ● | our
ability to maintain the listing of our public securities on the Nasdaq Capital Market; |
| ● | our
public securities’ potential liquidity and trading; |
| ● | our
success in retaining or recruiting, or changes required in, officers, key employees or directors; |
| ● | our
ability to grow and manage growth profitably; |
| ● | the
implementation, market acceptance and success of our business model, developments and projections
relating to our competitors and industry; |
| ● | our
ability to obtain and maintain intellectual property protection and not infringe on the rights
of others; |
| ● | our
ability to identify, in-license or acquire additional technology; and |
| ● | our
ability to maintain our existing license agreements and manufacturing arrangements. |
These
forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects.
There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements
involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or
performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties
include, but are not limited to, those factors described under the heading “Risk Factors” in Part I - Item 1A of our
Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 5, 2024, as updated by the factors described
under the heading “Risk Factors” in Part II - Item 1A of this Quarterly Report. Should one or more of these
risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from
those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified, and there
may be additional risks that we consider immaterial or which are unknown. It is not possible to predict or identify all such risks. Readers
are cautioned not to place undue reliance on forward-looking statements because of the risks and uncertainties related to them and
to the risk factors. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result
of new information, future events or otherwise, except as may be required under applicable securities laws.
Overview
We
are a clinical-stage biotechnology company focused on developing therapeutics targeting mast cell driven diseases such as Chronic Spontaneous
Urticaria (“CSU”), Chronic Inducible Urticaria (“CIndU”) and Asthma. We also have ongoing programs in diseases
where targeting diseased hemopoietic stem cells can provide benefits, such as Lower to Intermediate Risk Myelodysplastic Syndrome (“LR-MDS”),
and stem cell transplant conditioning regimens.
Our
lead product candidate, briquilimab, is a monoclonal antibody designed to block stem cell factor (“SCF”) from binding to
and signaling through the CD117 (“c-Kit”) receptor on mast and stem cells. The SCF/c-Kit pathway is a survival signal for
mast cells and we believe that blocking this pathway may lead to depletion of these cells from skin, which could lead to significant
clinical benefit for patients with mast-cell driven diseases such as chronic urticarias. To that end, we have commenced a Phase 1b/2a
clinical study in CSU, a Phase 1b/2a clinical study in CIndU, are planning to commence a Phase 1b/2a study in Asthma and are actively
evaluating the potential for briquilimab in additional mast cell driven diseases.
We
also believe that utilizing briquilimab to block SCF binding and signaling can result in the depletion of diseased hematopoietic stem
cells (“HSCs”) from the bone marrow in certain hematologic malignancies such as myelodysplastic syndrome (“MDS”),
and as a result, we are currently enrolling a Phase 1 trial evaluating briquilimab as a second-line therapy in patients with LR-MDS.
We are also developing briquilimab as a one-time conditioning therapy in severe combined immunodeficiency (“SCID”) patients
undergoing a second stem cell transplant for which we are currently conducting a Phase 1/2 clinical trial. Briquilimab is also being
studied by our academic and institutional partners, Stanford University and the National Institutes of Health, in other transplant settings,
including Fanconi Anemia (“FA”), sickle cell disease (“SCD”), chronic granulomatous disease and GATA-2 Type MDS.
We
intend to become a fully integrated discovery, development and commercial company in the field of mast cell therapeutics. We are developing
our product candidates to be used individually or, in some cases, in combination with other therapeutics. Our goal is to advance our
product candidates through regulatory approval and bring them to the commercial market based on the data from our clinical trials and
communications with regulatory agencies and payor communities. We expect to continue to broaden our pipeline with additional mast cell
indications and next-generation products by leveraging our research organization.
We
have an exclusive license agreement with Amgen Inc. (“Amgen”) for the development and commercialization of the briquilimab
monoclonal antibody in all indications and territories worldwide. We also have an exclusive license agreement with Stanford University
for the right to use briquilimab in the clearance of diseased stem cells prior to the transplantation of HSCs.
Since
our inception, we have devoted substantially all of our resources to performing research and development, enabling manufacturing activities
in support of our product development efforts, hiring personnel, acquiring and developing our technology and product candidates, performing
business planning, establishing our intellectual property portfolio, raising capital and providing general and administrative support
for these activities. We do not have any products approved for sale and have not generated any revenue from product sales. We expect
to continue to incur significant and increasing expenses and substantial losses for the foreseeable future as we continue our development
of and seek regulatory approvals for our product candidates and commercialize any approved products, seek to expand our product pipeline
and invest in our organization. We expect to incur increased expenses associated with operating as a public company, including significant
legal, audit, accounting, regulatory, tax-related, director and officer insurance, investor relations and other expenses.
We
have incurred significant losses and negative cash flows from operations since our inception. During the three and six months ended June
30, 2024, we incurred net losses of $14.6 million and $28.3 million, respectively. During the three and six months ended June
30, 2023, we incurred net losses of $16.1 million and $30.3 million, respectively. During the six months ended June 30, 2024 and 2023,
we had negative cash flows from operations of $27.4 million and $23.6 million, respectively. As of June 30, 2024, we had an
accumulated deficit of $197.9 million.
We
had cash and cash equivalents of $106.8 million as of June 30, 2024. We expect that our existing cash and cash equivalents will be sufficient
to fund our operating plan for at least twelve months from the date of filing of this Quarterly Report. We expect to continue to incur
substantial losses for the foreseeable future, and our transition to profitability will depend upon successful development, approval
and commercialization of our product candidates and upon achievement of sufficient revenues to support our cost structure. We do not
expect to generate any revenue from commercial product sales unless and until we successfully complete development and obtain regulatory
approval for one or more of our product candidates. We may never achieve profitability, and unless we do and until then, we will need
to continue to raise additional capital.
Our
management plans to monitor expenses and raise additional capital through a combination of public and private equity, debt financings,
strategic alliances, and licensing arrangements. Our ability to access capital when needed is not assured and, if capital is not available
to us when, and in the amounts, needed, we may be required to significantly curtail, delay or discontinue one or more of our research
or development programs or the commercialization of any product candidate, or be unable to expand our operations or otherwise capitalize
on our business opportunities, as desired, which could materially harm our business, financial condition and results of operations.
We
expect our expenses will increase substantially in connection with our ongoing and planned activities, as we:
| ● | advance
product candidates through preclinical studies and clinical trials; |
| ● | procure
the manufacture of supplies for our preclinical studies and clinical trials; |
| ● | acquire,
discover, validate, and develop additional product candidates; |
| ● | attract,
hire and retain additional personnel; |
| ● | operate
as a public company; |
| ● | implement
operational, financial and management systems; |
| ● | pursue
regulatory approval for any product candidates that successfully complete clinical trials; |
| ● | establish
a sales, marketing, and distribution infrastructure to commercialize any product candidate
for which we may obtain marketing approval and related commercial manufacturing build-out;
and |
| ● | obtain,
maintain, expand, and protect our portfolio of intellectual property rights. |
We
do not currently own or operate any manufacturing facility. We rely on contract manufacturing organizations (“CMOs”) to produce
our drug candidates in accordance with the FDA’s current good manufacturing practices (“cGMP”) regulations for use
in our clinical studies. The manufacture of pharmaceuticals is subject to extensive cGMP regulations, which impose various procedural
and documentation requirements and govern all areas of record keeping, production processes and controls, personnel and quality control.
Under our license agreement with Amgen, we have received a substantial amount of drug product to support initiation of our planned clinical
trials of briquilimab. In November 2019, we entered into development and manufacturing agreements with Lonza Sales AG (“Lonza”)
relating to the manufacturing of briquilimab and product quality testing. The facility of Lonza in Slough, United Kingdom is responsible
for production and testing of drug substance. The facility of Lonza in Stein, Switzerland is responsible for production and testing of
drug product. Labelling, packaging and storage of finished drug product is provided by PCI Pharma Services, in San Diego, California.
Our agreement with Lonza includes certain limitations on our ability to enter into supply arrangements with any other supplier without
Lonza’s consent. In addition, Lonza has the right to increase the prices it charges us for certain supplies depending on a number
of factors, some of which are outside of our control.
We
do not currently have sales and marketing infrastructure to support commercial launch of our product candidates, if approved. We may
build such capabilities in North America prior to potential launch of briquilimab. Outside of North America, we may rely on licensing,
co-sale and co-promotion agreements with strategic partners for the commercialization of our product candidates. If we build a commercial
infrastructure to support marketing in North America, such commercial infrastructure could be expected to include a targeted sales force
supported by sales management, internal sales support, an internal marketing group and distribution support. To develop the appropriate
commercial infrastructure internally, we would have to invest financial and management resources, some of which would have to be deployed
prior to any confirmation that briquilimab will be approved.
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 revenue from the sale of
our product candidates, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing
basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations.
Components
of Results of Operations
Operating
Expenses
Research
and Development
The
largest component of our total operating expenses since our inception has been research and development activities, including the preclinical
and clinical development of our product candidates. Research and development expenses consist primarily of compensation and benefits
for research and development employees, including stock-based compensation; expenses incurred under agreements with clinical research
organizations (“CROs”) and investigative sites that conduct preclinical and clinical studies; the costs of acquiring and
manufacturing clinical study materials and other supplies; payments under licensing and research and development agreements; other outside
services and consulting costs; and facilities, information technology and overhead expenses. Research and development costs are expensed
as incurred.
External
research and development costs include:
| ● | costs
incurred under agreements with third-party CROs, CMOs and other third parties that conduct
preclinical and clinical activities on our behalf and manufacture our product candidates; |
| ● | costs
associated with acquiring technology and intellectual property licenses that have no alternative
future uses; |
| ● | consulting
fees associated with our research and development activities; and |
| ● | other
costs associated with our research and development programs, including laboratory materials
and supplies. |
Internal
research and development costs include:
| ● | employee-related costs,
including salaries, benefits and stock-based compensation expense for our research and
development personnel; and |
| ● | other
expenses and allocated overheads incurred in connection with our research and development
programs. |
We
expect our research and development expenses to increase substantially for the foreseeable future as we advance our product candidates
into and through preclinical studies and clinical trials, pursue regulatory approval of our product candidates and expand our pipeline
of product candidates. The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly
and time-consuming. The actual probability of success for our product candidates may be affected by a variety of factors, including the
safety and efficacy of our product candidates, early clinical data, investment in our clinical programs, competition, manufacturing capability
and commercial viability. We may never succeed in achieving regulatory approval for any of our product candidates. As a result of the
uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects
or if, when and to what extent we will generate revenue from the commercialization and sale of our product candidates, if approved.
Our
future research and development costs may vary significantly based on factors, such as:
| ● | the
scope, rate of progress, expense and results of our discovery and preclinical development
activities; |
| ● | the
costs and timing of our chemistry, manufacturing and controls activities, including fulfilling
cGMP-related standards and compliance, and identifying and qualifying suppliers; |
| ● | per
patient clinical trial costs; |
| ● | the
number of trials required for approval; |
| ● | the
number of sites included in our clinical trials; |
| ● | the
countries in which the trials are conducted; |
| ● | delays
in adding a sufficient number of trial sites and recruiting suitable patients to participate
in our clinical trials; |
| ● | the
number of patients that participate in the trials; |
| ● | the
number of doses that patients receive; |
| ● | patient
drop-out or discontinuation rates; |
| ● | potential
additional safety monitoring requested by regulatory agencies; |
| ● | the
duration of patient participation in the trials and follow up; |
| ● | the
cost and timing of manufacturing our product candidates; |
| ● | the
phase of development of our product candidates; |
| ● | the
efficacy and safety profile of our product candidates; |
| ● | the
timing, receipt, and terms of any approvals from applicable regulatory authorities, including
the FDA and non-U.S. regulators; |
| ● | maintaining
a continued acceptable safety profile of our product candidates following approval, if any,
of our product candidates; |
| ● | significant
and changing government regulation and regulatory guidance; |
| ● | changes
in the standard of care on which a clinical development plan was based, which may require
new or additional trials; |
| ● | the
extent to which we establish additional strategic collaborations or other arrangements; and |
| ● | the
impact of any business interruptions to our operations or to those of the third parties with
whom we work, particularly in light of geopolitical and macroeconomic trends. |
General
and Administrative
General
and administrative expenses consist primarily of personnel costs and expenses, including salaries, employee benefits, stock-based compensation
for our executive and other administrative personnel; legal services, including relating to intellectual property and corporate matters;
accounting, auditing, consulting and tax services; insurance; and facility and other allocated costs not otherwise included in research
and development expenses. We expect our general and administrative expenses to increase substantially for the foreseeable future as we
anticipate an increase in our personnel headcount to support expansion of research and development activities, as well as to support
our operations generally. We also expect to continue to incur significant expenses associated with being a public company, including
costs related to accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with applicable
Nasdaq and SEC requirements; additional director and officer insurance costs; and investor and public relations costs.
Other
Income (Expense), Net
Other
income (expense), net includes foreign currency transactions gains and losses, interest income, changes in the fair value of common stock
warrant liability and earnout liability. These financial instruments were classified as liabilities in our condensed consolidated balance
sheets and re-measured at each reporting period end until they are exercised, settled or have expired. In January 2023, all outstanding
common stock warrants met equity classification and are no longer remeasured. The estimated fair value of the earnout liability was less
than $0.1 million as of June 30, 2024 and was minimal as of December 31, 2023, due to the price of our common stock relative to the price
that would trigger a release of the earnout shares.
Results
of Operations
Comparison
of the Three Months Ended June 30, 2024 and 2023
The
following table summarizes our results of operations for the three months ended June 30, 2024 and 2023 (in thousands, except percentages):
| |
Three
Months Ended June 30, | | |
Change | | |
Change | |
| |
2024 | | |
2023 | | |
$ | | |
% | |
Operating expenses | |
| | |
| | |
| | |
| |
Research and
development | |
$ | 11,296 | | |
$ | 13,297 | | |
$ | (2,001 | ) | |
| (15 | ) |
General
and administrative | |
| 4,697 | | |
| 4,530 | | |
| 167 | | |
| 4 | |
Total
operating expenses | |
| 15,993 | | |
| 17,827 | | |
| (1,834 | ) | |
| (10 | ) |
Loss from operations | |
| (15,993 | ) | |
| (17,827 | ) | |
| 1,834 | | |
| (10 | ) |
Interest income | |
| 1,450 | | |
| 1,436 | | |
| 14 | | |
| 1 | |
Change in fair value of
earnout liability | |
| — | | |
| 420 | | |
| (420 | ) | |
| (100 | ) |
Other
expense, net | |
| (40 | ) | |
| (109 | ) | |
| 69 | | |
| (63 | ) |
Total
other income, net | |
| 1,410 | | |
| 1,747 | | |
| (337 | ) | |
| (19 | ) |
Net loss and comprehensive
loss | |
$ | (14,583 | ) | |
$ | (16,080 | ) | |
$ | 1,497 | | |
| (9 | ) |
Research
and Development Expenses
The
following table summarizes our research and development expenses for the periods indicated (in thousands, except percentages):
| |
Three
Months Ended June 30, | | |
Change | | |
Change | |
| |
2024 | | |
2023 | | |
$ | | |
% | |
External costs: | |
| | |
| | |
| | |
| |
CRO,
CMO and other third-party preclinical studies and clinical trials | |
$ | 3,876 | | |
$ | 7,672 | | |
$ | (3,796 | ) | |
| (49 | ) |
Consulting
costs | |
| 1,170 | | |
| 1,213 | | |
| (43 | ) | |
| (4 | ) |
Other
research and development costs, including laboratory materials and supplies | |
| 1,093 | | |
| 531 | | |
| 562 | | |
| 106 | |
Total
external costs | |
| 6,139 | | |
| 9,416 | | |
| (3,277 | ) | |
| (35 | ) |
| |
| | | |
| | | |
| | | |
| | |
Internal
costs: | |
| | | |
| | | |
| | | |
| | |
Personnel-related
costs | |
| 3,753 | | |
| 2,643 | | |
| 1,110 | | |
| 42 | |
Facilities
and overhead costs | |
| 1,404 | | |
| 1,238 | | |
| 166 | | |
| 13 | |
Total
internal costs | |
| 5,157 | | |
| 3,881 | | |
| 1,276 | | |
| 33 | |
Total
research and development expense: | |
$ | 11,296 | | |
$ | 13,297 | | |
$ | (2,001 | ) | |
| (15 | ) |
Research
and development expenses decreased by $2.0 million, from $13.3 million for the three months ended June 30, 2023 to $11.3 million for
the three months ended June 30, 2024, mainly due to a decrease in product development activities.
External
clinical research organizations (“CRO”), contract manufacturing organization (“CMO”) and other third-party preclinical
studies and clinical trials expenses decreased by $3.8 million, from $7.7 million for the three months ended June 30, 2023 to $3.9 million
for the three months ended June 30, 2024. The decrease is primarily due to a $4.4 million decrease in manufacturing expenses, partially
offset by an increase of $0.4 million in CRO expenses and an increase of $0.1 million in other clinical studies and trial related expenses.
Other external research and development costs increased by $0.6 million, from $0.5 million for the three months ended June 30, 2023 to
$1.1 million for the three months ended June 30, 2024 due to increases in purchases of laboratory materials and supplies and other miscellaneous
costs.
Our
external costs by program for the three months ended June 30, 2024 and 2023 were as follows (in thousands):
|
|
Three
Months Ended
June 30, |
|
|
|
2024 |
|
|
2023 |
|
Chronic Urticarias |
|
$ |
2,286 |
|
|
$ |
551 |
|
Briquilimab platform |
|
|
2,348 |
|
|
|
6,276 |
|
SCID clinical trial |
|
|
603 |
|
|
|
652 |
|
MDS/AML clinical trial |
|
|
494 |
|
|
|
1,665 |
|
Other |
|
|
408 |
|
|
|
272 |
|
Total external costs |
|
$ |
6,139 |
|
|
$ |
9,416 |
|
Personnel-related
costs, including employee payroll and related expenses increased by $1.1 million, from $2.6 million for the three months ended June 30,
2023 to $3.8 million for the three months ended June 30, 2024, as a result of hiring additional employees in our research and development
organization. Facilities and overheads include common facilities, human resources and information technology related expenses allocated
to research and development, which increased by $0.2 million, from $1.2 million for the three months ended June 30, 2023 to $1.4 million
for the three months ended June 30, 2024.
General
and Administrative Expenses
General
and administrative expenses increased by $0.2 million, from $4.5 million for the three months ended June 30, 2023 to $4.7 million
for the three months ended June 30, 2024. Employee payroll and related expenses increased by $0.8 million, from $1.9 million for
the three months ended June 30, 2023 to $2.7 million for the three months ended June 30, 2024, as a result of continued hiring of
executives and administrative employees. Stock-based compensation expenses were $1.0 million and $0.9 million for the three months ended
June 30, 2024 and 2023, respectively. Expenses related to professional consulting services decreased by $0.3 million, from $1.9 million
for the three months ended June 30, 2023 to $1.6 million for the three months ended June 30, 2024. Other expenses, decreased by
$0.3 million for the three months ended June 30, 2024 as compared to the three months ended June 30, 2023, primarily related to
decreased insurance expenses.
Total
Other Income, Net
Total
other income, net decreased by $0.3 million, from $1.7 million for the three months ended June 30, 2023 to $1.4 million for the three
months ended June 30, 2024.
Interest
income increased by $0.1 million, from $1.4 million for the three months ended June 30, 2023 to $1.5 million for the three months ended
June 30, 2024, primarily due to higher cash balances invested in money market funds.
Our
earnout liability relates to the sponsor earnout shares placed in escrow upon the closing of the business combination in September 2021.
These shares will be released from escrow upon achieving agreed-upon common stock price targets within the specified period. Refer to
Note 7 in our condensed consolidated financial statements included in Part I - Item 1 of this Quarterly Report for additional details.
This liability is recorded at fair value using a Monte Carlo simulation model and is re-measured at each period end until shares are
released or forfeited. The significant inputs used in the Monte Carlo model include the expected volatility of our common stock, the
expected risk-free interest rate, the expected common stock closing price and the expected term when shares will be released. We recognized
zero and $0.4 million of other income related to changes in the fair value of the earnout liability for the six months ended June 30,
2024 and 2023, respectively, mainly due to changes in our common stock price during the respective periods.
Other
expense, net is comprised of foreign currency transactions gains and losses and was less than $0.1 million and $0.1 million for the six
months ended June 30, 2024 and 2023, respectively.
Comparison
of the Six Months Ended June 30, 2024 and 2023
The
following table summarizes our results of operations for the six months ended June 30, 2024 and 2023 (in thousands, except percentages):
| |
Six
Months Ended June 30, | | |
Change | | |
Change | |
| |
2024 | | |
2023 | | |
$ | | |
% | |
Operating expenses | |
| | |
| | |
| | |
| |
Research and
development | |
$ | 21,594 | | |
$ | 23,102 | | |
$ | (1,508 | ) | |
| (7 | ) |
General
and administrative | |
| 9,471 | | |
| 8,672 | | |
| 799 | | |
| 9 | |
Total
operating expenses | |
| 31,065 | | |
| 31,774 | | |
| (709 | ) | |
| (2 | ) |
Loss from operations | |
| (31,065 | ) | |
| (31,774 | ) | |
| 709 | | |
| (2 | ) |
Interest income | |
| 2,836 | | |
| 2,532 | | |
| 304 | | |
| 12 | |
Change in fair value of
earnout liability | |
| (20 | ) | |
| (344 | ) | |
| 324 | | |
| (94 | ) |
Change in fair value of
common stock warrant liability | |
| — | | |
| (575 | ) | |
| 575 | | |
| (100 | ) |
Other
expense, net | |
| (62 | ) | |
| (179 | ) | |
| 117 | | |
| (65 | ) |
Total
other income, net | |
| 2,754 | | |
| 1,434 | | |
| 1,320 | | |
| 92 | |
Net loss and comprehensive
loss | |
$ | (28,311 | ) | |
$ | (30,340 | ) | |
$ | 2,029 | | |
| (7 | ) |
Research
and Development Expenses
The
following table summarizes our research and development expenses for the periods indicated (in thousands, except percentages):
| |
Six
Months Ended June 30, | | |
Change | | |
Change | |
| |
2024 | | |
2023 | | |
$ | | |
% | |
External costs: | |
| | |
| | |
| | |
| |
CRO,
CMO and other third-party preclinical studies and clinical trials | |
$ | 7,922 | | |
$ | 12,432 | | |
$ | (4,510 | ) | |
| (36 | ) |
Consulting
costs | |
| 2,493 | | |
| 2,245 | | |
| 248 | | |
| 11 | |
Other
research and development costs, including laboratory materials and supplies | |
| 1,752 | | |
| 1,214 | | |
| 538 | | |
| 44 | |
Total
external costs | |
| 12,167 | | |
| 15,891 | | |
| (3,724 | ) | |
| (23 | ) |
| |
| | | |
| | | |
| | | |
| | |
Internal
costs: | |
| | | |
| | | |
| | | |
| | |
Personnel-related
costs | |
| 6,828 | | |
| 4,955 | | |
| 1,873 | | |
| 38 | |
Facilities
and overhead costs | |
| 2,599 | | |
| 2,256 | | |
| 343 | | |
| 15 | |
Total
internal costs | |
| 9,427 | | |
| 7,211 | | |
| 2,216 | | |
| 31 | |
Total
research and development expense: | |
$ | 21,594 | | |
$ | 23,102 | | |
$ | (1,508 | ) | |
| (7 | ) |
Research
and development expenses decreased by $1.5 million, from $23.1 million for the six months ended June 30, 2023 to $21.6 million for the
six months ended June 30, 2024, mainly due to a decrease in product development activities.
External
CRO, CMO and other third-party preclinical studies and clinical trials expenses decreased by $4.5 million, from $12.4 million for the
six months ended June 30, 2023 to $7.9 million for the six months ended June 30, 2024. The decrease is primarily due to a $6.7 million
decrease in manufacturing expenses and a $0.4 million decrease in expenses related to pre-clinical studies, partially offset by an increase
of $2.5 million in CRO expenses and an increase of $0.1 million in other clinical studies and trial related expenses. Expenses related
to professional consulting services increased by $0.2 million, from $2.2 million for the six months ended June 30, 2023 to $2.5 million
for the six months ended June 30, 2024, due to additional work performed by consultants related to our pre-clinical studies. Other external
research and development costs increased by $0.5 million, from $1.2 million for the six months ended June 30, 2023 to $1.7 million for
the six months ended June 30, 2024 due to increases in purchases of laboratory materials and supplies and other miscellaneous costs.
Our
external costs by program for the six months ended June 30, 2024 and 2023 were as follows (in thousands):
| |
Six
Months Ended June 30, | |
| |
2024 | | |
2023 | |
Chronic Urticarias | |
$ | 4,846 | | |
$ | 767 | |
Briquilimab platform | |
| 4,636 | | |
| 10,753 | |
MDS/AML clinical trial | |
| 1,069 | | |
| 2,534 | |
SCID clinical trial | |
| 1,007 | | |
| 1,032 | |
Other | |
| 609 | | |
| 805 | |
Total external costs | |
$ | 12,167 | | |
$ | 15,891 | |
Personnel-related
costs, including employee payroll and related expenses increased by $1.9 million, from $5.0 million for the six months ended June 30,
2023 to $6.8 million for the six months ended June 30, 2024, as a result of hiring additional employees in our research and development
organization. Stock-based compensation expenses decreased by $0.2 million, from $1.0 million for the six months ended June 30, 2023 to
$0.8 million for the six months ended June 30, 2024. Facilities and overheads include common facilities, human resources and information
technology related expenses allocated to research and development, which increased by $0.3 million, from $2.3 million for the six months
ended June 30, 2023 to $2.6 million for the six months ended June 30, 2024.
General
and Administrative Expenses
General
and administrative expenses increased by $0.8 million, from $8.7 million for the six months ended June 30, 2023 to $9.5 million
for the six months ended June 30, 2024. Employee payroll and related expenses increased by $1.6 million, from $3.6 million for the
six months ended June 30, 2023 to $5.2 million for the six months ended June 30, 2024, as a result of continued hiring of executives
and administrative employees. Stock-based compensation expenses were $1.8 million and $1.7 million for the six months ended June 30,
2024 and 2023, respectively. Expenses related to professional consulting services decreased by $0.1 million, from $3.4 million for
the six months ended June 30, 2023 to $3.3 million for the six months ended June 30, 2024. Other expenses, including insurance,
office supplies, subscriptions and other miscellaneous expenses, decreased by $0.8 million for the six months ended June 30, 2024
as compared to the six months ended June 30, 2023, primarily related to decreased insurance expenses, investor and public relations related
expenses and expensed software.
Total
Other Income, Net
Total
other income, net increased by $1.4 million, from $1.4 million for the six months ended June 30, 2023 to $2.8 million for the six months
ended June 30, 2024.
Interest
income increased by $0.3 million, from $2.5 million for the six months ended June 30, 2023 to $2.8 million for the six months ended June
30, 2024, primarily due to higher cash balances invested in money market funds.
We
recognized zero and $0.6 million of other expenses related to the change in the fair value of the common stock warrants for the six months
ended June 30, 2024 and 2023, respectively. These warrants are publicly traded, were classified as liabilities and were remeasured at
fair value, which was the closing market price of a warrant, at the end of each reporting period until January 2023. In January 2023,
an investor converted all its outstanding shares of non-voting common stock into shares of voting common stock, and we no longer have
any outstanding shares of non-voting common stock. As such, the outstanding warrants met equity classification criteria, were reclassified
to equity and are no longer remeasured at fair value at the end of each reporting period.
Our
earnout liability relates to the sponsor earnout shares placed in escrow upon the closing of the business combination in September 2021.
These shares will be released from escrow upon achieving agreed-upon common stock price targets within the specified period. Refer to
Note 7 in our condensed consolidated financial statements included in Part I - Item 1 of this Quarterly Report for additional details.
This liability is recorded at fair value using a Monte Carlo simulation model and is re-measured at each period end until shares are
released or forfeited. The significant inputs used in the Monte Carlo model include the expected volatility of our common stock, the
expected risk-free interest rate, the expected common stock closing price and the expected term when shares will be released. We recognized
less than $0.1 million and $0.3 million of other expense related to the increase in the fair value of the earnout liability for the six
months ended June 30, 2024 and 2023, respectively, mainly due to the increase in our common stock price during the respective periods.
Other
expense, net is comprised of foreign currency transactions gains and losses and was less than $0.1 million and $0.2 million for the six
months ended June 30, 2024 and 2023, respectively.
Liquidity
and Capital Resources
As
of June 30, 2024, we had $106.8 million of cash and cash equivalents.
In
order to assist in funding our future operations, including our planned clinical trials, on April 28, 2023, we filed a universal shelf
registration statement on Form S-3 with the SEC, which was declared effective on May 5, 2023 and will expire on May 5, 2026 (the “S-3”),
which allows us to, from time to time, offer up to $250.0 million of securities, including any combination of common stock, preferred
stock, debt securities, warrants, rights, units and depositary shares. We believe that the S-3 will provide us with the flexibility to
raise additional capital to finance our operations as needed. From time to time, we may offer securities under the S-3 in response to
market conditions or other circumstances if we believe such a plan of financing is in the best interests of our stockholders. The terms
of any offering under the S-3 will be established at the time of such offering and will be described in a prospectus supplement to the
S-3 filed with the SEC prior to the completion of any such offering.
On
November 10, 2022, we entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”)
with Cantor Fitzgerald & Co. (the “Agent”), pursuant to which we may offer and sell through or to the Agent, as sales
agent or principal, shares of our voting common stock from time to time (the “ATM Offering”). The Agent will use commercially
reasonable efforts consistent with its normal sales and trading practices to sell shares from time to time, based upon our instructions
(including any price or size limits or other customary parameters or conditions we may impose). We will pay a commission equal to 3.0%
of the aggregate gross proceeds of any shares sold through the Agent pursuant to the Sales Agreement. We are not obligated to sell any
shares under the Sales Agreement. The Sales Agreement will continue until all shares available under the Sales Agreement have been sold
unless it is terminated earlier. On May 5, 2023, we filed with the SEC a prospectus under the S-3 in connection with the ATM Offering
(the “ATM Prospectus”), pursuant to which we may offer and sell shares of common stock having an aggregate offering price
of up to $75.0 million. As of June 30, 2024, there have been no sales pursuant to the ATM Prospectus.
In
February 2024, we closed an underwritten offering that was conducted off the S-3 and issued 3,900,000 shares of common stock for net
proceeds of $47.2 million. As of June 30, 2024, $75.0 million remained allocated and available under the ATM Prospectus and $124.5 million
remained available and unallocated under the S-3.
Future
Funding Requirements
Our
primary uses of cash are to fund our operations, which consist primarily of research and development expenditures related to our programs
and, to a lesser extent, general and administrative expenditures. We anticipate that we will continue to incur significant expenses for
the foreseeable future as we continue to advance our product candidates, expand our corporate infrastructure, operate as a public company,
further our research and development initiatives for our product candidates, scale our laboratory and manufacturing operations, and incur
marketing costs associated with potential commercialization. We are subject to all the risks typically related to the development of
new drug candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may
adversely affect our business. We anticipate that we will need substantial additional funding in connection with our continuing operations.
We
have incurred significant losses and negative cash flows from operations since our inception. As of June 30, 2024, we had an accumulated
deficit of $197.9 million. Based on our current operating plan, we have concluded that our existing cash and cash equivalents will
be sufficient to fund our current operating plan for at least the next twelve months from the date of filing of this Quarterly Report.
We have based these estimates on our current assumptions, which may require future adjustments based on our ongoing business decisions.
Our
future financing requirements will depend on many factors, including:
| ● | the
timing, scope, progress, results and costs of research and development, preclinical and non-clinical studies
and clinical trials for our current and future product candidates; |
| ● | the
number, scope and duration of clinical trials required for regulatory approval of our current
and future product candidates; |
| ● | the
outcome, timing and costs of seeking and obtaining regulatory approvals from the FDA and
comparable foreign regulatory authorities for our product candidates, including any requirement
to conduct additional studies or generate additional data beyond that which we currently
expect would be required to support a marketing application; |
| ● | the
costs of manufacturing clinical and commercial supplies of our current and future product
candidates; |
| ● | the
costs and timing of future commercialization activities, including product manufacturing,
marketing, sales and distribution, for any of our product candidates for which we receive
marketing approval; |
| ● | any
product liability or other lawsuits related to our product candidates; |
| ● | the
revenue, if any, received from commercial sales of any product candidates for which we may
receive marketing approval; |
| ● | our
ability to establish a commercially viable pricing structure and obtain approval for coverage
and adequate reimbursement from third-party and government payers; |
| ● | the
costs to establish, maintain, expand, enforce and defend the scope of our intellectual property
portfolio, including the amount and timing of any payments we may be required to make, or
that we may receive, in connection with licensing, preparing, filing, prosecuting, defending
and enforcing our patents or other intellectual property rights; |
| ● | expenses
incurred to attract, hire and retain skilled personnel; and |
| ● | the
costs of operating as a public company. |
A
change in the outcome of any of these or other variables could significantly change the costs and timing associated with the development
of our product candidates. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational
needs and capital requirements associated with such change.
Contractual
Obligations and Commitments
We
enter into contracts in the normal course of business with CROs for clinical trials, with CMOs for clinical supplies manufacturing
and with other vendors for preclinical studies, supplies and other services and products for operating purposes. These contracts generally
provide for termination on notice or may have a potential termination fee if a purchase order is cancelled within a specified time,
and therefore are cancelable contracts. We do not expect any such contract terminations and did not have any non-cancellable obligations
under these agreements as of June 30, 2024.
Leases
In
August 2020 and January 2022, we leased approximately 13,400 square feet of space for our headquarters in Redwood City, California. The
lease expires in August 2026. We have an option to extend the term for an additional five years to August 2031. In addition to base rent,
we pay our share of operating expenses and taxes. As of June 30, 2024, our rent commitments under the lease agreement were $1.2 million
within the next 12 months from June 30, 2024, and $1.3 million for the remainder of the lease term.
Stanford
Sponsored Research Agreement
Effective
September 2020, we entered into a sponsored research agreement with Stanford for a research program related to the treatment of Fanconi
Anemia patients in Bone Marrow Failure requiring allogeneic transplant with non-sibling donors at Stanford Lucile Packard Children’s
Hospital using briquilimab. As consideration for the services performed by Stanford under this sponsored research agreement, we agreed
to pay Stanford a total of $0.9 million over approximately three years upon the achievement of development and clinical milestones, including
FDA filings and patient enrollment. In February 2021, we paid $0.3 million related to the achievement of the first milestone under this
agreement. In February 2022, the second milestone was achieved, and we paid $0.3 million in March 2022. The third and final milestone
in the amount of $0.3 million was achieved in July 2023 and was recognized as a research and development expense in the condensed consolidated
statements of operations and comprehensive loss for the year ended December 31, 2023.
Stanford
License Agreement
In
March 2021, we entered into the Stanford License Agreement. In July 2023, we entered into an amendment to the Stanford License Agreement
to modify certain milestones set forth thereunder. Pursuant to the Stanford License Agreement we are required to pay annual license maintenance
fees, beginning on the first anniversary of the effective date of the agreement and ending upon the first commercial sale of a product,
method, or service in the licensed field of use, as follows: $25,000 for each first and second year, $35,000 for each third and fourth
year, and $50,000 at each anniversary thereafter ending upon the first commercial sale. We are also obligated to pay late-stage clinical
development milestone payments and first commercial sales milestone payments of up to $9.0 million in total. We will also pay low single-digit
royalties on net sales of licensed products. All products were in development as of June 30, 2024, and no such royalties were due as
of such date and no milestones were achieved.
Cash
Flows
The
following table summarizes our sources and uses of cash for the periods presented (in thousands):
| |
Six
Months Ended June 30, | |
| |
2024 | | |
2023 | |
Net cash used in operating activities | |
$ | (27,416 | ) | |
$ | (23,607 | ) |
Net cash used in investing activities | |
| (182 | ) | |
| (37 | ) |
Net cash provided by
financing activities | |
| 47,530 | | |
| 101,206 | |
Net increase in cash and
cash equivalents and restricted cash | |
$ | 19,932 | | |
$ | 77,562 | |
Cash
Flows Used in Operating Activities
Net
cash used in operating activities was $27.4 million and $23.6 million for the six months ended June 30, 2024 and 2023, respectively.
Cash
used in operating activities in the six months ended June 30, 2024 was primarily due to our net loss for the period of $28.3 million,
adjusted by non-cash net loss of $3.5 million and a net change of $2.6 million in our net operating assets and liabilities. The non-cash
amounts consisted of $2.7 million related to stock-based compensation expense, $0.6 million related to depreciation and amortization
expense, and $0.2 million non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to a decrease
of $1.3 million in accounts payable, a decrease of $1.2 million in accrued expenses and other current liabilities, a decrease of $0.5
million in operating lease liability, offset by a decrease of $0.2 million in prepaid expenses and other current assets and a decrease
of $0.2 million in other non-current assets.
Cash
used in operating activities in the six months ended June 30, 2023 was primarily due to our net loss for the period of $30.3 million,
adjusted by non-cash net loss of $4.3 million and a net change of $2.4 million in our net operating assets and liabilities.
The non-cash amounts consisted of $2.7 million related to stock-based compensation expense, $0.9 million net loss related to the changes
in fair value of common stock warrant liability and the earnout liability, $0.5 million related to depreciation and amortization expense
and $0.2 million non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to an increase of
$2.0 million in accrued expenses and other current liabilities, a decrease of $0.7 million in other receivables and a decrease of $0.3
million in other non-current assets, partially offset by a decrease of $0.4 million in operating lease liability and a decrease of $0.2
million in accounts payable.
Cash
Flows Used in Investing Activities
Cash
used in investing activities was $0.2 million and less than $0.1 million for the six months ended June 30, 2024 and 2023, respectively,
which primarily consisted of leasehold improvements, purchases of the computer and lab equipment.
Cash
Flows Provided by Financing Activities
Cash
provided by financing activities for the six months ended June 30, 2024 was $47.5 million, which consisted primarily of net proceeds
from the issuance and sale of shares of common stock in an underwritten public offering of $47.2 million and cash received from the exercise
of stock options of $0.3 million.
Cash
provided by financing activities for the six months ended June 30, 2023 was $101.2 million, which consisted primarily of net proceeds
from the issuance and sale of shares of common stock in an underwritten public offering and the ATM Offering of $101.5 million, cash
received from the exercise of stock options of $0.4 million and cash received from the issuance of common stock upon Employee Stock Purchase
Plan purchase of less than $0.1 million, partially offset by taxes withheld and paid related to net settlement of equity awards of $0.7
million.
Critical
Accounting Policies and Significant Judgments and Estimates
Our
critical accounting policies are disclosed in Note 2 of the notes to the consolidated financial statements included in Part II - Item
8 of the Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 5, 2024. Since the date of such
financial statements, there have been no material changes to our significant accounting policies.
Recently
Issued Accounting Pronouncements
See
Note 2 to the condensed consolidated financial statements included in Part I - Item 1 of this Quarterly Report for more information regarding
recently issued accounting pronouncements.
JOBS
Act
The
Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) exempts emerging growth companies from being required to comply
with new or revised financial accounting standards until private companies (that is, those that have not had a U.S. Securities Act of
1933, as amended, registration statement declared effective or do not have a class of securities registered under the Securities Exchange
Act of 1934, as amended (the “Exchange Act”)) are required to comply with the new or revised financial accounting standards.
The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply
to non-emerging growth companies but any such election to opt out is irrevocable. We have opted to take advantage of the exemption for
complying with new or revised accounting standards within the same time periods as private companies, which means that when a standard
is issued or revised and it has different application dates for public or private companies, we, as an emerging growth company, can adopt
the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of our condensed
consolidated financial statements with another public company that is neither an emerging growth company nor an emerging growth company
that has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting
standards used.
We
will remain an emerging growth company until the earlier of: (i) the last day of the fiscal year (a) following November 22, 2024, (b)
in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer,
which means the market value of our common equity that is held by non-affiliates exceeds $700 million as of the last business day of
its most recently completed second fiscal quarter; and (ii) the date on which we have issued more than $1.00 billion in non-convertible
debt securities during the prior three-year period. References herein to “emerging growth company” have the meaning associated
with it in the JOBS Act.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
There
have been no material changes to our market risk during the six months ended June 30, 2024. For a discussion of our exposure to market
risk, refer to the section titled “Quantitative and Qualitative Disclosures About Market Risk” included in Part II - Item
7A of the Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 5, 2024.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in the reports
we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities
and Exchange Commission’s rules and forms. Our disclosure controls and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed by us in the reports we file under the Exchange Act is accumulated and communicated
to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions
regarding required disclosure.
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. As required by Rule 13a-15(b)
or Rule 15d-15(b) promulgated by the Securities and Exchange Commission under the Exchange Act, we carried out an evaluation, under the
supervision and with the participation of our management, including our principal executive officer and principal financial officer,
of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this
Quarterly Report. Based on the foregoing, our principal executive officer and principal financial officer concluded that our disclosure
controls and procedures were effective as of the end of the period covered by this Quarterly Report at the reasonable assurance level.
Changes
in Internal Controls
There
have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange
Act) during the quarter ended June 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
We
are not currently party to, and none of our property is currently the subject of, any material legal proceedings.
Item
1A. Risk Factors
Our
Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 5, 2024, in Part I –Item 1A, Risk
Factors, describes important risk factors that could cause our business, financial condition, results of operations and growth prospects
to differ materially from those indicated or suggested by forward-looking statements made in this Quarterly Report or presented elsewhere
by management from time to time. Except as set forth below, there have been no material changes in the risk factors that appear in Part
I - Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 5, 2024. Additional risks
and uncertainties not currently known to us or that we currently deem to be immaterial may also materially and adversely affect our business.
Risks
Related to Our Financial Position and Need for Additional Capital
We
have incurred significant net losses and negative operating cash flows since our inception. We expect to incur net losses for the foreseeable
future and may never achieve or maintain profitability.
We
are a clinical-stage biotechnology company dedicated to enabling cures through therapeutics targeting mast and hematopoietic stem cells
and have a limited operating history. Investment in biopharmaceutical product development is highly speculative because it entails substantial
upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate effect or an
acceptable safety profile, gain regulatory approval and become commercially viable. We have no products approved for commercial sale
and have not generated any revenue from product sales to date, and we continue to incur significant research and development and other
expenses related to our ongoing operations. As a result, we are not profitable and have incurred losses and negative operating cash flows
in each period since our inception. For the six months ended June, 2024 and 2023, we reported net losses of $28.3 million and $30.3
million, respectively. For the six months ended June 30, 2024 and 2023, we reported negative operating cash flows of $27.4 million
and $23.6 million, respectively. As of June 30, 2024, we had an accumulated deficit of $197.9 million. We have devoted all of our efforts
to organizing and staffing our company, business and scientific planning, raising capital, acquiring and developing technology, identifying
potential product candidates, undertaking research and preclinical studies of potential product candidates, developing manufacturing
capabilities and evaluating a clinical path for our pipeline programs. We expect to continue to incur significant expenses and increasing
operating losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and
seek regulatory approvals for, our product candidates.
The
net losses we incur may fluctuate significantly from quarter to quarter. We anticipate that our expenses will increase substantially
if and as we:
|
● |
continue the clinical development of briquilimab in
chronic diseases such as Chronic Spontaneous Urticaria (“CSU”), Chronic Inducible Urticaria (“CIndU”), Asthma,
Lower to Intermediate Risk Myelodysplastic Syndrome (“LR-MDS”) and other indications; |
|
● |
continue the open label Phase 1/2 clinical trial
for briquilimab for Severe Combined Immunodeficiency (“SCID”) and the Phase 1b/2a clinical trial of subcutaneous briquilimab
for the treatment of CIndU; |
|
● |
continue our current research programs and development
of other potential product candidates from our current research programs; |
|
● |
seek to identify additional product candidates and
research programs; |
|
● |
initiate preclinical testing and clinical trials for
any other product candidates we identify and develop; |
|
● |
maintain, expand, enforce, defend and protect our intellectual
property portfolio, and provide reimbursement of third-party expenses related to our patent portfolio; |
|
● |
seek marketing approvals for any product candidates
that successfully complete clinical trials; |
|
● |
ultimately establish a sales, marketing and distribution
infrastructure to commercialize any product candidates for which we may obtain marketing approval; |
|
● |
adapt our regulatory compliance efforts to incorporate
requirements applicable to any approved product candidates; |
|
● |
hire additional research and development and clinical
personnel; |
|
● |
hire commercial personnel and advance market access
and reimbursement strategies; |
|
● |
add operational, financial and management information
systems and personnel, including personnel to support our product development; |
|
● |
acquire or in-license product candidates, intellectual
property and technologies; |
|
● |
develop or in-license manufacturing and distribution
technologies; |
|
● |
should we decide to do so and receive approval for
any of our product candidates, build and maintain, or purchase and validate, commercial-scale manufacturing facilities designed
to comply with current Good Manufacturing Practices (“cGMP”) requirements; and |
|
● |
incur additional legal, accounting and other expenses
in operating as a public company. |
As
a company, we have not completed clinical development of any product candidate and expect that it will be several years, if ever,
before we have a product candidate ready for commercialization. To become and remain profitable, we must develop and, either directly
or through collaborators, eventually commercialize a product or products with significant market potential. This will require us to be
successful in a range of challenging activities, including identifying product candidates, completing preclinical testing and clinical
trials of product candidates, obtaining marketing approval for these product candidates, manufacturing, marketing and selling those products
for which we may obtain marketing approval and satisfying any post-marketing requirements.
We
may never succeed in these activities and, even if we do, may never generate revenues that are significant or large enough to achieve
profitability. Our product candidates and research programs are currently only in the early stages of development. Because of the numerous
risks and uncertainties associated with developing product candidates, we are unable to predict the extent of any future losses or when
we will become profitable, if at all. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly
or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to
raise capital, maintain our research and development efforts, expand our business or continue our operations. A decline in the value
of our company could also cause you to lose all or part of your investment.
We
will need substantial additional funding, which may not be available on acceptable terms, or at all. If we are unable to raise capital
when needed, we would be forced to delay, reduce or eliminate our research and product development programs or future commercialization
efforts.
We
expect to spend substantial amounts of cash to conduct further research and development and preclinical testing and clinical trials of
our product candidates, to seek regulatory approvals for our product candidates and to launch and commercialize any product candidates
for which we receive regulatory approval. Furthermore, we expect to incur additional costs associated with operating as a public company.
Accordingly, we will need to obtain substantial additional funding in order to maintain our continuing operations. If we are unable to
raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and product development
programs or future commercialization efforts. As of June 30, 2024, our cash and cash equivalents were $106.8 million and we had an accumulated
deficit of $197.9 million. Although we raised total estimated net proceeds of $47.2 million in February 2024 in connection with the issuance
and sale of 3,900,000 shares of our common stock in an underwritten offering, we will need to raise additional financing to continue
our products’ development for the foreseeable future, and will continue to need to do so until we become profitable. Our future
financing requirements will depend on many factors, including:
|
● |
the initiation, progress, timing, costs and results
of preclinical studies and clinical trials for our product candidates; |
|
● |
the costs of continuing to build our technology platform
for use in developing our product candidates; |
|
● |
the costs of developing, acquiring or in-licensing additional
targeted therapies to use in combination with briquilimab and other product candidates we may develop; |
|
● |
the costs of preparing, filing and prosecuting patent
applications, maintaining and enforcing our intellectual property and proprietary rights and defending intellectual property-related claims
in the United States and internationally; |
|
● |
the number and characteristics of product candidates
that we develop or may in-license; |
|
● |
our ability to establish and maintain collaborations
on favorable terms, if at all; |
|
● |
the achievement of milestones or occurrence of other
developments that trigger payments under any collaboration agreements we enter into; |
|
● |
the outcome, timing and cost of meeting regulatory
requirements established by the U.S. Food and Drug Administration (the “FDA”), the European Medical Agency (the
“EMA”) and other comparable foreign regulatory authorities; |
|
● |
the cost and timing of completion of commercial-scale outsourced
manufacturing activities; |
|
● |
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; and |
|
● |
the costs of operating as a public company. |
Conducting
preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we
may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, even if
we successfully develop product candidates and those are approved, we may not achieve commercial success. Our commercial revenues, if
any, will be derived from sales of products that we do not expect to be commercially available for several years, if at all. Accordingly,
we will need to continue to rely on additional financing to achieve our business objectives.
We
currently have an effective universal shelf registration statement on Form S-3, which we filed with the SEC on April 28, 2023, and which
was declared effective on May 5, 2023 and will expire on May 5, 2026 (the “Shelf Registration Statement”). Pursuant to the
Shelf Registration Statement, we may offer from time to time up to an aggregate of $250.0 million of securities, including any combination
of common stock, preferred stock, debt securities, warrants, rights, units and depositary shares. On November 10, 2022, we entered into
a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co. (the “Agent”), pursuant to
which we may offer and sell through or to the Agent, as sales agent or principal, shares of common stock from time to time (the “ATM
Offering”). On May 5, 2023, we filed with the SEC under the Shelf Registration Statement a prospectus with the SEC in connection
with the ATM Offering (the “ATM Prospectus”), pursuant to which we may offer pursuant to the ATM Offering shares of our common
stock having an aggregate offering price of up to $75.0 million. No securities were sold pursuant to the ATM Prospectus as of June 30,
2024. In February 2024, we issued and sold 3,900,000 shares of our common stock in an underwritten offering pursuant to the Shelf Registration
Statement for an estimated net proceeds of $47.2 million pursuant an underwriting agreement with Cowen and Company, LLC and Evercore
Group L.L.C., as the representatives of the several underwriters named therein.
As of August 9, 2024, $75.0 million remains allocated and available
under the ATM Prospectus and approximately $124.5 million remains available and unallocated under the Shelf Registration Statement.
If
we raise additional capital by issuing equity securities, the percentage ownership of our existing stockholders may be reduced, and accordingly
these stockholders may experience substantial dilution. We may also issue equity securities that provide for rights, preferences and
privileges senior to those of our common stock. Given our need for cash and that equity issuances are the most common type of fundraising
for similarly situated companies, the risk of dilution is particularly significant for our stockholders.
Any
additional fundraising efforts may divert our management from our day-to-day activities, which may adversely affect our ability
to develop and commercialize product candidates. We cannot be certain that additional funding will be available on acceptable terms,
or at all. We have no committed source of additional capital and, if we are unable to raise additional capital in sufficient amounts
or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of product
candidates or other research and development initiatives. Our license agreements and any future collaboration agreements may also be
terminated if we are unable to meet the payment or other obligations under the agreements. We could be required to seek collaborators
for product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise
be available or relinquish or license on unfavorable terms our rights to product candidates in markets where we otherwise would seek
to pursue development or commercialization ourselves.
Our
management believes that our existing cash and cash equivalents as of June 30, 2024 will be sufficient to fund our operating plan for
at least twelve months from the date of filing of this Quarterly Report. However, we will need to raise additional financing to
continue our products’ development for the foreseeable future, and will continue to need to do so until we become profitable. If
we are unable to obtain funding when and as needed on a timely basis, we may be required to significantly curtail, delay or discontinue
one or more of our research or development programs or the commercialization of any product candidate, or be unable to expand our operations
or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and
results of operations. Any of the above events could significantly harm our business, prospects, financial condition and results of operations
and cause the price of our common stock to decline.
As
a result of our history of losses and negative cash flows from operations, we will need to raise additional financing to continue our
products’ development.
Our
history of operating losses and negative cash flows from operations combined with our anticipated use of cash to fund operations raised
substantial doubt about our ability to continue as a going concern beyond the 12-month period reported by us and our auditors
in prior periods. While management believes that our existing cash and cash equivalents as of June 30, 2024, will be sufficient to fund
our operating plan for at least twelve months from the filing date of this Quarterly Report, we will need to raise additional financing
to continue our products’ development for the foreseeable future, and will continue to need to do so until we become profitable.
Our future viability as an ongoing business is dependent on our ability to generate cash from our operating activities or to raise additional
capital to finance our operations.
The
perception that we might be unable to continue as a going concern may also make it more difficult to obtain financing for the continuation
of our operations on terms that are favorable to us, or at all, and could result in the loss of confidence by investors and employees.
Our consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. If we are
unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets
are carried on our consolidated financial statements, and it is likely that our investors will lose all or a part of their investment.
Risks
Related to Discovery, Development, Manufacturing and Commercialization
We
may not be successful in our efforts to identify, develop and commercialize additional product candidates. If these efforts are
unsuccessful, we may never become a commercial stage company or generate any revenues.
The
success of our business depends primarily upon our ability to identify, develop, and commercialize additional product candidates based
on, or complementary with, our technology platform. We are currently enrolling patients in a Phase 1b/2a trial evaluating briquilimab
in patients with CSU, a Phase1b/2a trial evaluating briquilimab in patients with CIndU, a Phase 1 trial evaluating briquilimab as a second-line
therapy in subjects with LR-MDS and a Phase 1/2 clinical trial of briquilimab as a conditioning agent prior to allogenic transplant
for SCID patients. We are also in the process of initiating other product development programs in mast cell driven diseases that are
still in the research or preclinical stage of development, and in May 2024, we announced the expansion of our mast cell development program
with a Phase 1b/2a study evaluating briquilimab in asthma patients. Our research programs may fail to identify additional indications
for clinical development or product candidates for clinical development for a number of reasons. Our research methodology may be unsuccessful
in identifying potential product candidates, our potential product candidates may be shown to have harmful side effects in preclinical
in vitro experiments or animal model studies, they may not show promising signals of efficacy in such experiments or studies or they
may have other characteristics that may make the product candidates impractical to manufacture, unmarketable or unlikely to receive marketing
approval. The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing
standards of medical care, and other unpredictable variables. In addition, although we believe our technology platform will position
us to rapidly expand our portfolio of product candidates beyond our current product candidates, our ability to expand our portfolio may
never materialize.
If
any of these events occur, we may be forced to abandon our research or development efforts for a program or programs, which would have
a material adverse effect on our business, financial condition, results of operations and prospects. Research programs to identify new
product candidates require substantial technical, financial and human resources. We may focus our efforts and resources on potential
programs or product candidates that ultimately prove to be unsuccessful, which would be costly and time-consuming.
We
may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates
or indications that may be more profitable or for which there is a greater likelihood of success.
Because
we have limited financial and managerial resources, we focus on research programs and product candidates that we identify for specific
indications among many potential options. As a result, we may forego or delay pursuit of opportunities with other product candidates
or for other indications that later prove to have greater commercial potential. For example, on January 10, 2023, we announced, as part
of an overall portfolio prioritization, that we will focus on the development of our lead product candidate, briquilimab (formerly known
as JSP191), in chronic mast and stem cell diseases as well as a conditioning agent for stem cell transplant in rare diseases. This portfolio
includes new programs as a therapeutic for patients with CSU and CIndU, along with our existing programs for briquilimab as a therapeutic
for patients with LR-MDS and as a conditioning agent for stem cell transplant in patients with sickle cell disease, Fanconi anemia or
severe combined immunodeficiency. In addition, in May 2024, we announced the expansion of our mast cell development program with a Phase
1b/2a study evaluating briquilimab in asthma patients. Our resource allocation decisions may cause us to fail to capitalize on viable
commercial medicines or profitable market opportunities. Our projections of both the number of people who have these diseases, as well
as the subset of people with these diseases who have the potential to benefit from treatment with our product candidates, are based on
estimates. If any of our estimates are inaccurate, the market opportunities for any of our product candidates could be significantly
diminished and have an adverse material impact on our business. Additionally, the potentially addressable patient population for our
product candidates may be limited, or may not be amenable to treatment with our product candidates. Our spending on current and future
research and development programs and product candidates for specific indications may not yield any commercially viable product candidates.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate (including briquilimab),
we may relinquish valuable rights to that product candidate through collaboration, licensing, or other royalty arrangements in cases
in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.
Any such event could have a material adverse effect on our business, financial condition, results of operations and prospects.
Risks
Related to Other Legal Compliance Matters
Investors’
expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to
new risks.
There
is an increasing focus from certain investors, employees, regulators and other stakeholders concerning corporate responsibility, specifically
related to environmental, social and governance (“ESG”) factors. Some investors and investor advocacy groups may use these
factors to guide investment strategies and, in some cases, investors may choose not to invest in our company if they believe our policies
relating to corporate responsibility are inadequate. Third-party providers of corporate responsibility ratings and reports on companies
have increased to meet growing investor demand for measurement of corporate responsibility performance, and a variety of organizations
currently measure the performance of companies on such ESG topics, and the results of these assessments are widely publicized. Investors,
particularly institutional investors, use these ratings to benchmark companies against their peers and if we are perceived as lagging
with respect to ESG initiatives, certain investors may engage with us to improve ESG disclosures or performance and may also make voting
decisions, or take other actions, to hold us and our board of directors accountable. In addition, the criteria by which our corporate
responsibility practices are assessed may change, which could result in greater expectations of us and cause us to undertake costly initiatives
to satisfy such new criteria. If we elect not to or are unable to satisfy such new criteria, investors may conclude that our policies
with respect to corporate responsibility are inadequate.
We
may face reputational damage in the event our corporate responsibility initiatives or objectives do not meet the standards set by our
investors, stockholders, lawmakers, listing exchanges or other constituencies, or if we are unable to achieve an acceptable ESG or sustainability
rating from third-party rating services. A low ESG or sustainability rating by a third-party rating service could also result in the
exclusion of our common stock from consideration by certain investors who may elect to invest with our competition instead. Ongoing focus
on corporate responsibility matters by investors and other parties as described above may impose additional costs or expose us to new
risks. Any failure or perceived failure by us in this regard could have a material adverse effect on our reputation and on our business,
share price, financial condition, or results of operations, including the sustainability of our business over time.
In
addition, on March 6, 2024, the SEC finalized new rules for public companies that will require, among other things, climate-related disclosures
and analysis of the impact of climate-related issues on our business strategy, results of operations, and financial condition (the “SEC
Climate Disclosure Rules”). The new rules require disclosure of, among other things and to the extent material, our climate-related
risks and opportunities, greenhouse gas emissions inventory, climate-related targets and goals, and financial impacts of physical and
transition risks. Subsequently, in April 2024, the SEC issued an order staying implementation of the SEC Climate Disclosure Rules pending
the resolution of certain challenges. Nonetheless, our legal, accounting, and other compliance expenses may increase significantly,
and compliance efforts may divert management time and attention as we prepare for the potential implementation of the SEC Climate Disclosure
Rules, and such expenses, efforts and diversions of management time and attention may be even greater if the SEC Climate Disclosure Rules
ultimately go into effect. We may also be exposed to legal or regulatory action or claims as a result of these new regulations. Separately,
the SEC has also announced that it is scrutinizing existing climate-change related disclosures in public filings, increasing the potential
for enforcement if the SEC were to allege our existing climate disclosures are misleading or deficient. All of these risks could have
a material adverse effect on our business, financial position, and/or stock price.
Risks
Related to Employee Matters, Managing Growth and Information Technology
We
will need to grow the size of our organization, and we may experience difficulties in managing this growth.
As
of June 30, 2024, we had 56 full-time employees. As our development, manufacturing and commercialization plans and strategies develop
and we continue our operations as a public company, we expect to need and are actively recruiting additional managerial, operational,
sales, marketing, financial and other personnel. Future growth would impose significant added responsibilities on members of management,
including:
|
● |
identifying, recruiting, integrating, maintaining and
motivating additional employees; |
|
● |
managing our internal development efforts effectively,
including the clinical, FDA and international regulatory review process for our product candidates, while complying with our contractual
obligations to contractors and other third parties; and |
|
● |
improving our operational, financial and management
controls, reporting systems and procedures. |
Our
future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to effectively
manage any future growth, and our management may also have to divert a disproportionate amount of time to managing these growth activities.
We
currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors
and consultants to provide certain services, including substantially all aspects of regulatory approval, clinical management and manufacturing.
We cannot assure you that the services of independent organizations, advisors and consultants will continue to be available to us on
a timely basis when needed, or that we can find qualified replacements. In addition, if we are unable to effectively manage our outsourced
activities or if the quality or accuracy of the services provided by consultants is compromised for any reason, our clinical trials may
be extended, delayed or terminated, and we may not be able to obtain regulatory approval of our product candidates or otherwise advance
our business. We cannot assure you that we will be able to manage our existing consultants or find other competent outside contractors
and consultants on economically reasonable terms, or at all. If we are not able to effectively expand our organization by hiring new
employees and expanding our groups of consultants and contractors, or if we are not able to effectively build out new facilities to accommodate
this expansion, we may not be able to successfully implement the tasks necessary for further development and commercialization of our
product candidates and, accordingly, may not achieve our research, development and commercialization goals.
Risks
Related to Ownership of Our Common Stock and Warrants
If
our operations and performance do not meet the expectations of investors or securities analysts or for other reasons, the market price
of our securities may decline, and the market price of our common stock may continue to be volatile.
Any
of the factors listed below could have a negative impact on your investment in our securities, and our securities may trade at prices
significantly below the price you paid for them. In such circumstances, the trading price of our securities may not recover and may experience
a further decline.
Factors
affecting the trading price of our securities may include:
|
● |
adverse regulatory decisions; |
|
● |
any delay in our regulatory filings for our product
candidates and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s
review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request
for additional information; |
|
● |
the Israel-Hamas war, the ongoing conflict between
Ukraine and Russia and the global impact of restrictions and sanctions imposed on Russia and the impact thereof on the markets generally,
including any adverse effects on macroeconomic conditions such as inflation; |
|
● |
the commencement, enrollment or results of any future
clinical trials we may conduct, or changes in the development status of our product candidates; |
|
● |
adverse results from, delays in or termination of clinical
trials; |
|
● |
unanticipated serious safety concerns related to the
use of our product candidates; |
|
● |
lower than expected market acceptance of our product
candidates following approval for commercialization; |
|
● |
changes in financial estimates by us or by any securities
analysts who might cover our stock; |
|
● |
changes in the market valuations of similar companies; |
|
● |
stock market price and volume fluctuations of comparable
companies and, in particular, those that operate in the biopharmaceutical industry; |
|
● |
publication of research reports about us or our industry
or positive or negative recommendations or withdrawal of research coverage by securities analysts; |
|
● |
announcements by us or our competitors of significant
acquisitions, strategic partnerships or divestitures; |
|
● |
announcements of investigations or regulatory scrutiny
of our operations or lawsuits filed against us; |
|
● |
investors’ general perception of our business
or management; |
|
● |
recruitment or departure of key personnel; |
|
● |
overall performance of the equity markets; |
|
● |
disputes or other developments relating to intellectual
property rights, including patents, litigation matters and our ability to obtain, maintain, defend, protect and enforce patent and
other intellectual property rights for our technologies; |
|
● |
significant lawsuits, including patent or stockholder
litigation; |
|
● |
proposed changes to healthcare laws in the U.S. or
foreign jurisdictions, or speculation regarding such changes; |
|
● |
general political and economic conditions; and |
|
● |
other events or factors, many of which are beyond our
control. |
In addition, the stock market in general, Nasdaq and pharmaceutical
companies, in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to
the operating performance of these companies. The trading price of our common stock is, and is likely to continue to be, volatile. For
example, from January 3, 2023 to December 31, 2023, our closing stock price ranged from $4.24 to $27.40 per share, and from January 2,
2024 to August 9, 2024, our closing stock price ranged from $6.63 to $30.00 per share. Broad market and industry factors may negatively
affect the market price of our securities, regardless of our actual operating performance. As a result of this volatility, our stockholders
may not be able to sell their common stock at or above the prices at which they purchased their shares. Moreover, in the past, stockholders
have initiated class action lawsuits against pharmaceutical and biotechnology companies following periods of volatility in the market
prices of these companies’ stock. Such litigation, if instituted against us, could cause us to incur substantial costs and divert
management’s attention and resources from our business.
Insiders
have substantial control over us, which could limit your ability to affect the outcome of key transactions, including a change of control.
As of June 30, 2024, our directors and executive officers and their
affiliates beneficially owned approximately 19% of the outstanding shares of our common stock. As a result, these stockholders, if they
act together, will be able to influence our management and affairs and all matters requiring stockholder approval, including the election
of directors and approval of significant corporate transactions, such as a merger or other sale of our company or our assets. This concentration
of ownership may have the effect of delaying or preventing a change in control of our company or discouraging a potential acquirer from
making a tender offer or otherwise attempting to obtain control, even if that change in control would benefit our other stockholders.
This significant concentration of ownership may also adversely affect the trading price for our common stock because investors often perceive
disadvantages in owning stock in companies with controlling stockholders.
Future
sales, or the perception of future sales, by us or our stockholders in the public market, the issuance of rights to purchase our common
stock, including pursuant to the Equity Incentive Plan and the ESPP, and future exercises of registration rights could result in the
additional dilution of the percentage ownership of our stockholders and cause the market price for our common stock to decline.
The
sale of shares of our common stock, convertible securities or other equity securities in the public market, or the perception that such
sales could occur, could harm the prevailing market price of shares of our common stock. These sales, or the possibility that these sales
may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.
In addition, if we sell shares of our common stock, convertible securities or other equity securities, investors may be materially diluted
by subsequent sales. Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights,
preferences, and privileges senior to the holders of our common stock.
Pursuant
to the Jasper Therapeutics, Inc. 2024 Equity Incentive Plan (the “Equity Incentive Plan”), which became effective on June
6, 2024, we are authorized to grant equity awards to our employees, directors and consultants. In addition, pursuant to the Jasper Therapeutics,
Inc. 2024 Employee Stock Purchase Plan (the “ESPP”), which became effective on June 6, 2024, we are authorized to sell shares
to our employees. As of June 30, 2024, 2,764,111 shares and 1,000,000 shares of our common stock are reserved for future issuance under
the Equity Incentive Plan and the ESPP, respectively.
On
March 14, 2022, the Compensation Committee of our Board of Directors (the “Compensation Committee”) adopted the 2022 Inducement
Equity Incentive Plan (the “2022 Inducement Plan”). On June 2, 2023, the Compensation Committee approved an amendment and
restatement of our 2022 Inducement Plan to increase the maximum number of shares of our voting common stock available for grant by 250,000
shares of common stock to an aggregate of 550,000 shares of common stock. As of June 30, 2024, 15,885 shares of our common stock are
available for future issuance under the 2022 Inducement Plan. The 2022 Inducement Plan has not been and will not be approved by our stockholders.
Under the 2022 Inducement Plan, we can grant nonstatutory stock options, restricted stock awards, stock appreciation rights, restricted
stock units, performance awards and other awards, but only to an individual, as a material inducement to such individual to enter into
employment with us or an affiliate of ours, who (i) has not previously been an employee or director of ours or (ii) is rehired following
a bona fide period of non-employment with us.
As
of June 30, 2024, options to purchase an aggregate of 1,543,752 shares of our common stock, 20,000 performance-based restricted stock
units and no restricted stock units were outstanding, and we have granted additional options to purchase shares of our common stock after
this date.
Pursuant
to the Amended and Restated Registration Rights Agreement entered into in connection with the Business Combination, certain of our stockholders
can demand that we register their registrable securities under certain circumstances and will each also have piggyback registration rights
for these securities. In addition, we are required to file and maintain an effective registration statement under the Securities Act
covering such securities and certain of our other securities. We filed a registration statement on October 18, 2021, which was first
amended on March 29, 2022 and further amended on October 7, 2022, in order to satisfy the foregoing obligations and we have currently
registered for resale an aggregate of 3,601,936 shares of our common stock, including up to 499,986 shares of our common stock issuable
upon exercise of our outstanding warrants. The registration of these securities permits the public sale of such securities, subject to
certain contractual restrictions on transfer imposed by the Amended and Restated Registration Rights Agreement and the Business Combination
Agreement, which contractual restrictions on transfer terminated on March 23, 2022. The presence of these additional shares of our common
stock trading in the public market may have an adverse effect on the market price of our securities.
In
the future, we may also issue our securities in connection with investments or acquisitions. The amount of shares of our common stock
issued in connection with an investment or acquisition could constitute a material portion of our then-outstanding shares of our common
stock. Any issuance of additional securities in connection with investments or acquisitions may result in additional dilution to our
stockholders.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
Not
applicable.
Item
3. Defaults Upon Senior Securities
Not
applicable.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
During
the fiscal quarter ended June 30, 2024, none of our directors or officers (as defined in Section 16 of the Securities Exchange Act of
1934, as amended) adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was
intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement,” as
defined in Item 408(a) of Regulation S-K.
Item
6. Exhibits
Exhibit
Number |
|
Description |
|
Registrant’s
Form |
|
Date Filed
with the
SEC |
|
Exhibit
Number |
3.1 |
|
Second Amended and Restated Certificate of Incorporation of the Registrant. |
|
8-K |
|
9/29/2021 |
|
3.1 |
|
|
|
|
|
|
|
|
|
3.2 |
|
Certificate of Amendment to the Second Amended and Restated Certificate of Incorporation, dated June 8, 2023. |
|
8-K |
|
6/8/2023 |
|
3.1 |
|
|
|
|
|
|
|
|
|
3.3 |
|
Certificate of Second Amendment to the Second Amended and Restated Certificate of Incorporation of Jasper Therapeutics, Inc., filed with the Secretary of State of the State of Delaware on January 3, 2024. |
|
8-K |
|
1/3/2024 |
|
3.1 |
|
|
|
|
|
|
|
|
|
3.4 |
|
Third Amended and Restated Bylaws of the Registrant. |
|
8-K |
|
2/17/2023 |
|
3.1 |
|
|
|
|
|
|
|
|
|
4.1 |
|
Form of Warrant Agreement, dated November 19, 2019, by and between the Registrant and Continental Stock Transfer & Trust Company, as warrant agent. |
|
8-K |
|
11/25/2019 |
|
4.1 |
|
|
|
|
|
|
|
|
|
4.2 |
|
Specimen Warrant Certificate. |
|
S-1/A |
|
11/6/2019 |
|
4.3 |
|
|
|
|
|
|
|
|
|
10.1# |
|
Jasper Therapeutics, Inc. 2024 Equity Incentive Plan. |
|
S-8 |
|
6/7/2024 |
|
4.3 |
|
|
|
|
|
|
|
|
|
10.2# |
|
Form of Stock Option Award Agreement under the Jasper Therapeutics, Inc. 2024 Equity Incentive Plan. |
|
S-8 |
|
6/7/2024 |
|
4.4 |
|
|
|
|
|
|
|
|
|
10.3# |
|
Form of Restricted Stock Unit Award Agreement under the Jasper Therapeutics, Inc. 2024 Equity Incentive Plan. |
|
S-8 |
|
6/7/2024 |
|
4.5 |
|
|
|
|
|
|
|
|
|
10.4# |
|
Form of Restricted Stock Award Agreement under the Jasper Therapeutics, Inc. 2024 Equity Incentive Plan. |
|
S-8 |
|
6/7/2024 |
|
4.6 |
|
|
|
|
|
|
|
|
|
10.5# |
|
Jasper Therapeutics, Inc. 2024 Employee Stock Purchase Plan. |
|
S-8 |
|
6/7/2024 |
|
4.7 |
|
|
|
|
|
|
|
|
|
10.6# |
|
Amended and Restated Employment Agreement, dated as of June 10, 2024, by and between Jasper Therapeutics, Inc. and Ronald Martell. |
|
8-K |
|
6/12/2024 |
|
10.3 |
|
|
|
|
|
|
|
|
|
10.7# |
|
Amended and Restated Employment Agreement, dated as of June 10, 2024, by and between Jasper Therapeutics, Inc. and Herb Cross. |
|
8-K |
|
6/12/2024 |
|
10.4 |
|
|
|
|
|
|
|
|
|
10.8# |
|
Amended and Restated Employment Agreement, dated as of June 10, 2024, by and between Jasper Therapeutics, Inc. and Jeet Mahal. |
|
8-K |
|
6/12/2024 |
|
10.5 |
|
|
|
|
|
|
|
|
|
10.9# |
|
Amended and Restated Employment Agreement, dated as of June 10, 2024, by and between Jasper Therapeutics, Inc. and Edwin Tucker. |
|
8-K |
|
6/12/2024 |
|
10.6 |
# |
Indicates a management
contract or compensatory plan or arrangement. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
JASPER
THERAPEUTICS, INC. |
|
|
Date: August
13, 2024 |
By: |
/s/
Ronald Martell |
|
|
Ronald Martell |
|
|
President and Chief
Executive Officer |
|
|
(Principal Executive
Officer) |
|
|
Date: August 13, 2024 |
By: |
/s/
Herb Cross |
|
|
Herb Cross |
|
|
Chief Financial Officer |
|
|
(Principal Accounting
and Financial Officer) |
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