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 March 31, 2025

 

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 CityCA

  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 May 8, 2025, the number of shares of the registrant’s common stock outstanding was 15,022,122 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

MARCH 31, 2025

 

TABLE OF CONTENTS

 

    PAGE
  PART I. FINANCIAL INFORMATION  
     
Item 1. Financial Statements (Unaudited) 1
     
  Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024 1
     
  Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31 2025 and 2024 2
     
  Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2025 and 2024 3
     
  Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2025 and 2024 4
     
  Notes to Condensed Consolidated Financial Statements 5
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 19
     
Item 3. Quantitative and Qualitative Disclosures About Market Risk 32
     
Item 4. Controls and Procedures 32
     
  PART II. OTHER INFORMATION  
     
Item 1. Legal Proceedings 33
     
Item 1A. Risk Factors 33
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 43
     
Item 3. Defaults Upon Senior Securities 43
     
Item 4. Mine Safety Disclosures 43
     
Item 5. Other Information 43
     
Item 6. Exhibits 44
     
SIGNATURES 45

 

i

 

 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

JASPER THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

(unaudited)

 

   March 31,   December 31, 
   2025   2024 
Assets       
Current assets:        
Cash and cash equivalents  $48,799   $71,637 
Prepaid expenses and other current assets   4,375    4,174 
Total current assets   53,174    75,811 
           
Property and equipment, net   1,599    1,875 
Operating lease right-of-use assets   1,875    976 
Restricted cash   417    417 
Other non-current assets   532    820 
Total assets  $57,597   $79,899 
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable  $2,995   $4,027 
Current portion of operating lease liabilities   1,835    1,089 
Accrued expenses and other current liabilities   7,504    10,121 
Total current liabilities   12,334    15,237 
Non-current portion of operating lease liabilities   755    724 
Other non-current liabilities   2,264    2,264 
Total liabilities   15,353    18,225 
           
Commitments and contingencies (Note 7)   
    
 
Stockholders’ equity        
Preferred stock: $0.0001 par value — 10,000,000 shares authorized at March 31, 2025 and December 31, 2024; none issued and outstanding at March 31, 2025 and December 31, 2024   
    
 
Common stock: $0.0001 par value — 492,000,000 shares authorized at March 31, 2025 and December 31, 2024; 15,022,122 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively   2    2 
Additional paid-in capital   304,352    302,541 
Accumulated deficit   (262,110)   (240,869)
Total stockholders’ equity   42,244    61,674 
Total liabilities and stockholders’ equity  $57,597   $79,899 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

1

 

 

JASPER THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share data)

(unaudited)

 

   Three Months Ended
March 31,
 
   2025   2024 
Operating expenses        
Research and development  $16,157   $10,298 
General and administrative   5,645    4,774 
Total operating expenses   21,802    15,072 
Loss from operations   (21,802)   (15,072)
Interest income   624    1,386 
Other expense, net   (63)   (42)
Total other income, net   561    1,344 
Net loss and comprehensive loss  $(21,241)  $(13,728)
Net loss per share attributable to common stockholders, basic and diluted  $(1.41)  $(1.03)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted   15,022,122    13,334,900 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

2

 

 

JASPER THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(in thousands, except share data)

(unaudited)

 

   Common Stock   Additional
Paid-In
   Accumulated   Total
Stockholders’
 
   Shares   Amount   Capital   Deficit   Equity 
Balance as of December 31, 2024   15,022,122   $2   $302,541   $(240,869)  $61,674 
Stock-based compensation expense       
    1,811    
    1,811 
Net loss       
    
    (21,241)   (21,241)
Balance as of March 31, 2025   15,022,122   $2   $304,352   $(262,110)  $42,244 

 

   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   21,657    
       —
    154    
    154 
Issuance of common stock through underwritten offering, net of discounts and commissions and issuance costs of $3.3 million   3,900,000    1    47,194    
    47,195 
Stock-based compensation expense       
    1,169    
    1,169 
Net loss       
    
    (13,728)   (13,728)
Balance as of March 31, 2024   15,085,553   $2   $296,556   $(183,328)  $113,230 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

3

 

 

JASPER THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

   Three Months Ended
March 31,
 
   2025   2024 
Cash flows used in operating activities        
Net loss  $(21,241)  $(13,728)
Adjustments to reconcile net loss to net cash used in operating activities          
Depreciation and amortization expense   279    288 
Non-cash lease expense   193    116 
Stock-based compensation expense   1,811    1,169 
Changes in operating assets and liabilities:          
Prepaid expenses and other current assets   (201)   218 
Other non-current assets   288    (80)
Accounts payable   (1,039)   (1,758)
Accrued expenses and other current liabilities   (2,617)   (1,728)
Operating lease liability   (315)   (233)
Net cash used in operating activities   (22,842)   (15,736)
Cash flows used in investing activities          
Purchases of property and equipment   
    (25)
Proceeds from sales of property and equipment   4    
 
Net cash provided by (used in) investing activities   4    (25)
Cash flows from financing activities          
Proceeds from issuance of common stock through ATM and underwritten offerings, net   
    47,195 
Proceeds from exercise of common stock options   
    154 
Net cash provided by financing activities   
    47,349 
Net increase (decrease) in cash, cash equivalents and restricted cash   (22,838)   31,588 
Cash, cash equivalents and restricted cash at beginning of the period   72,054    87,304 
Cash, cash equivalents and restricted cash at end of the period  $49,216   $118,892 
Supplemental and non-cash items reconciliations          
Right-of-use asset obtained in exchange for lease liabilities  $1,092   $
 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 

 

4

 

 

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, including chronic spontaneous urticaria, chronic inducible urticaria and asthma. The Company has also historically explored diseases where targeting diseased hematopoietic stem cells can provide benefits, such as 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. 

  

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”) for 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, 2024 included in the Company’s Annual Report on the Form 10-K filed with the SEC on February 28, 2025. The information as of December 31, 2024, 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 months ended March 31, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025 or for any other interim period or for any other future year.

 

Going Concern

 

In accordance with Accounting Standards Codification (“ASC”) Topic 205-40, Going Concern, the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of the Company’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, the Company evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about its ability to continue as a going concern. The mitigating effect of the Company’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. In performing this analysis, the Company excluded certain elements of its operating plan that cannot be considered probable.

 

5

 

 

The Company has incurred significant losses and negative cash flows from operations since its inception. During the three months ended March 31, 2025 and 2024, the Company incurred net losses of $21.2 million and $13.7 million, respectively. During the three months ended March 31, 2025 and 2024, the Company had negative operating cash flows of $22.8 million and $15.7 million, respectively. As of March 31, 2025, the Company had an accumulated deficit of $262.1 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.

 

Management expects to finance the Company’s future cash needs through equity or debt financings, collaborations or a combination of these approaches. However, due to several factors, including those outside management’s control, there can be no assurance that the Company will be able to complete additional financings. The Company’s ability to raise additional funds may be adversely impacted by negative global economic conditions and any disruptions to and volatility in the credit and financial markets in the United States and worldwide or other factors. There can be no assurance that the Company will be successful in acquiring additional funding at levels sufficient to fund its operations or on terms favorable or acceptable to the Company. If the Company is unable to obtain adequate financing when needed or on terms favorable or acceptable to it, the Company may be forced to delay, reduce the scope of or eliminate one or more of its research and development programs. The Company concluded the likelihood that its plan to successfully obtain sufficient funding or adequately delay or reduce expenditures, while reasonably possible, is less than probable. As of March 31, 2025, the Company had cash and cash equivalents of $48.8 million. The Company’s management expects that the existing cash and cash equivalents will not be sufficient to fund the Company’s operating plans for at least twelve months from the issuance date of these condensed consolidated financial statements. Accordingly, the Company has concluded that substantial doubt exists about its ability to continue as a going concern.

 

The accompanying unaudited interim condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. These unaudited interim condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.

  

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.

 

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 condensed consolidated financial statements include, but are not limited to, the determination of the accrued research and development expenses, 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.

 

6

 

 

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):

 

   March 31,   December 31, 
   2025   2024 
Cash and cash equivalents  $48,799   $71,637 
Restricted cash   417    417 
Total cash, cash equivalents and restricted cash  $49,216   $72,054 

 

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 7).

 

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 (the “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 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.

 

Segment Reporting

 

The Company has one reportable and operating segment. Financial information about the Company’s operating segment is presented in Note 12.

 

7

 

 

Recent Accounting Pronouncements

 

Accounting Pronouncements Not Yet Adopted

  

In December 2023, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“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 does not expect the adoption of this ASU to have a significant impact on the Company’s condensed consolidated financial statements.

 

 In November 2024, the FASB issued ASU No. 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses to improve financial reporting by requiring that public business entities disclose additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. In January 2025, the FASB issued ASU No. 2025-01, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date (“ASU 2025-01”). The amendments do not change or remove current expense disclosure requirements; however, the amendments affect where such information appears in the notes to financial statements because entities are required to include certain current disclosures in the same tabular format disclosure as the other disaggregation requirements in the amendments. The amendments are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact of adopting this ASU to its 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. 

 

8

 

 

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 March 31, 2025 and December 31, 2024.

 

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. The Company had no financial instruments classified at Level 3 as of March 31, 2025 and December 31, 2024.

 

There were no transfers within the hierarchy during the three months ended March 31, 2025 and 2024.

 

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): 

 

   March 31, 2025 
   Level 1   Level 2   Level 3   Total 
Financial assets                
Money market funds  $47,799   $
   $
   $47,799 
Total fair value of assets  $47,799   $
   $
   $47,799 

 

   December 31, 2024 
   Level 1   Level 2   Level 3   Total 
Financial assets                
Money market funds  $70,637   $
   $
   $70,637 
Total fair value of assets  $70,637   $
   $
   $70,637 

 

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): 

 

   March 31,   December 31, 
   2025   2024 
Research and development prepaid expenses  $2,558   $2,604 
Prepaid insurance   549    784 
Prepaid travel expenses   414    140 
Other prepaid expenses and current assets   854    646 
Total  $4,375   $4,174 

 

9

 

 

Property and equipment, net

 

The following table summarizes the details of property and equipment, net as of the dates set forth below (in thousands): 

 

   March 31,   December 31, 
   2025   2024 
Leasehold improvements  $2,711   $2,711 
Lab equipment   2,044    2,049 
Office furniture & fixtures   522    522 
Computer equipment   310    310 
Capitalized software   90    90 
Property and equipment, gross   5,677    5,682 
Less: accumulated depreciation and amortization   (4,078)   (3,807)
Property and equipment, net  $1,599   $1,875 

 

Depreciation and amortization expense for each of the three months ended March 31, 2025 and 2024 was $0.3 million.

 

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):

 

   March 31,   December 31, 
   2025   2024 
Research and development accrued expenses  $5,671   $6,424 
Accrued employee and related compensation expenses   1,063    3,100 
Contributions under Employee Stock Purchase Plans   327    111 
Other   443    486 
Total  $7,504   $10,121 

 

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 inventions 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 March 31, 2025. As of March 31, 2025, the CIRM grant has been closed and there are no further amounts available for future distribution to the Company under the grant. As of each of March 31, 2025 and December 31, 2024, the amount of CIRM grant received of $2.3 million is included in other non-current liabilities in the condensed consolidated balance sheets.

 

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NOTE 6. SIGNIFICANT AGREEMENTS

 

Stanford License Agreements 

 

In March 2021, the Company entered into an exclusive license agreement with Stanford (the “2021 Stanford License Agreement”). In July 2023, the Company entered into an amendment to the 2021 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 2021 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 license maintenance fee in March 2024, and recognized this as research and development expense in the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024. No license maintenance fee was paid during the three months ended March 31, 2025.

 

The 2021 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. 

 

In December 2024, the Company entered into a co-exclusive license agreement with Stanford (the “2024 Stanford License Agreement”). The Company received a co-exclusive license in the United States, with a right to sublicense, for a certain patent to be used in the field of the treatment and prevention of human diseases, including the use of anti-CD117 antibodies (other than JSP191) for the purpose of depleting endogenous blood stem cells in patients for whom hematopoietic cell transplantation is indicated (the “Co-Exclusive Licensed Field of Use”) and an exclusive license in the United States for the use of the same patent in the field provided in the 2021 Stanford License Agreement (the “Exclusive Licensed Field of Use”). Stanford will have at most one other commercial license for the licensed patent in the Co-Exclusive Licensed Field of Use. Under the terms of this agreement, the Company is required to use commercially reasonable efforts to develop, manufacture and sell a 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 approximately 4.5 years from the execution of the agreement and must notify Stanford in writing when, and if, each milestone is met.

 

The Company was obligated to pay a license issue fee of $75,000, following the execution of the agreement, which was paid in January 2025. The Company is also obligated to pay annual license maintenance fees, beginning on the first anniversary of the effective date of the agreement, as follows: $25,000 for each of the first through third years, $50,000 for each of the fourth through sixth years and $65,000 at each anniversary thereafter. The Company is also obligated to pay clinical development milestone payments of up to $1.3 million and sales milestone payments of up to $7.0 million in total. The Company will pay low single-digit royalties on net sales of licensed products, if approved. The Company will pay Stanford a portion of sublicensee consideration if a sublicense is granted.

 

The Company may terminate the agreement by giving Stanford written notice at least 30 days in advance of the effective date of termination. Stanford may terminate the agreement by giving the Company 90 days written notice for a problem, including a delinquency on any report required pursuant to the agreement, missing a milestone or a material breach, and by giving the Company 30 days written notice for a payment default, unless the Company remediates the problem in that 90-day or 30-day period. 

 

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NOTE 7. COMMITMENTS AND CONTINGENCIES

 

Operating Leases

 

As of March 31, 2025, the Company leased approximately 25,900 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 March 2025, the Company extended its existing short-term lease for 12,500 square feet of laboratory and office space in Redwood City, California, through August 2026. As a result, the Company recorded a right-of-use asset and lease liability of $1.1 million in March 2025.

 

In addition to base rent, the Company pays its share of operating expenses and taxes. These variable costs are recorded as lease expense as incurred and presented as operating expenses in the condensed consolidated statements of operations and comprehensive loss.

 

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):

 

   Three Months Ended
March 31,
 
   2025   2024 
Lease cost        
Operating lease cost  $232   $168 
Short-term lease cost   169    1 
Variable lease cost   118    70 
Total lease cost  $519   $239 

 

Supplemental information related to the Company’s operating leases is as follows:

 

   Three Months Ended
March 31,
 
   2025   2024 
         
Cash paid for amounts included in the measurement of lease liabilities (in thousands)  $356   $285 
Weighted average remaining lease term (years)   1.4    2.4 
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 March 31, 2025 (in thousands):

 

Year Ending December 31,  Amount 
     
2025 (remainder of the year)  $1,467 
2026   1,260 
Total undiscounted lease payments   2,727 
Less imputed interest   (137)
Total discounted lease payments   2,590 
Less current portion of lease liability   (1,835)
Noncurrent portion of lease liability  $755 

 

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License Agreements

 

In March 2021, the Company entered into the 2021 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 March 31, 2025, and no royalties were due as of such date. The Company paid $35,000 license maintenance fee in March 2024, and recognized this as a research and development expense in the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024. As of March 31, 2025 and December 31, 2024, no milestones were probable to be achieved and payable.

 

In December 2024, the Company entered into the 2024 Stanford License Agreement (Note 6), pursuant to which the Company is required to pay a license issue and annual license maintenance fees, clinical development and commercial sales milestone payments of up to an aggregate of $8.3 million and low single-digit royalties on net sales of licensed products. All products were in development as of March 31, 2025, and no royalties were due as of such date. As of March 31, 2025, 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 three months ended March 31, 2025 and 2024, 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 March 31, 2025 and December 31, 2024, the Company does not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities.

 

NOTE 8. 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 15,022,122 shares of voting common stock, no shares of non-voting common stock and no shares of preferred stock issued and outstanding as of March 31, 2025.

 

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. There were no outstanding shares of non-voting common stock as of March 31, 2025 and December 31, 2024.

 

13

 

 

As of March 31, 2025 and December 31, 2024, the Company had common stock reserved for future issuance as follows:

 

   March 31,   December 31, 
   2025   2024 
Outstanding and issued common stock options   2,186,226    1,628,378 
Shares issuable upon exercise of common stock warrants   499,986    499,986 
Shares available for grant under Equity Incentive Plans   1,199,754    1,791,291 
Shares available for grant under Employee Stock Purchase Plans   981,370    981,370 
Shares available for grant under 2022 Inducement Equity Incentive Plan   50,574    16,885 
Total shares of common stock reserved   4,917,910    4,917,910 

 

Shelf Registration Statement

 

On April 28, 2023, the Company filed a shelf registration statement on Form S-3 (the “Prior S-3”) with the SEC, which was declared effective on May 5, 2023. The Company could 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 Prior S-3.

 

On March 19, 2025, the Company filed a new shelf registration statement on Form S-3 (the “New S-3”) with the SEC, which was declared effective on March 26, 2025 and superseded the Prior S-3. As of March 31, 2025, the Company can sell from time to time up to $300.0 million of common stock, preferred stock, debt securities, warrants, rights, units and 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 (the “Cantor Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), pursuant to which the Company could offer and sell through or to Cantor, as sales agent or principal, shares of the Company’s common stock from time to time (the “Prior ATM Offering”). On November 10, 2022 and May 5, 2023, the Company filed with the SEC prospectuses under the Prior S-3 in connection with the Prior 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 and $75.0 million, respectively. 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 March 14, 2025, the Company and Cantor terminated the Cantor Sales Agreement.

 

On March 19, 2025, the Company entered into an Open Market Sale AgreementSM with Jefferies LLC (“Jefferies”), pursuant to which the Company may offer and sell through or to Jefferies, as sales agent or principal, shares of common stock from time to time (the “ATM Offering”). On March 26, 2025, 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 may offer and sell shares of common stock having an aggregate offering price of up to $100.0 million.

 

As of March 31, 2025, $100.0 million remained available under the ATM Prospectus.

 

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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 Prior S-3 of 3,900,000 shares of common stock. The Company received net proceeds of $47.2 million.

 

As of March 31, 2025, $200.0 million remained available and unallocated under the New S-3.

 

NOTE 9. STOCK-BASED COMPENSATION

 

As of March 31, 2025, 2,762,719 shares were reserved for issuance under the 2024 Equity Incentive Plan (the “2024 Plan”), of which 1,199,754 shares were available for future grant and 1,562,965 shares were subject to outstanding options and restricted stock units (“RSUs”), including performance-based awards of 65,894. As of March 31, 2025, options to purchase 143,835 shares of common stock remained outstanding and unexercised and continue to be governed by the 2019 Equity Incentive Plan (the “2019 EIP”). As of March 31, 2025, 29,802 shares have been issued under the 2021 Employee Stock Purchase Plan (the “2021 ESPP”) and 18,630 shares under the 2024 Employee Stock Purchase Plan (the “2024 ESPP”). As of March 31, 2025, 1,000,000 shares were reserved under the 2024 ESPP and 981,370 shares were available for future issuance. As of March 31, 2025, 550,000 shares were reserved for issuance under the 2022 Inducement Equity Incentive Plan (the “2022 Inducement Plan”), of which 50,574 shares were available for future grant and 499,426 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, the 2021 Equity Incentive Plan (the “2021 Plan”), the 2022 Inducement Plan and the 2019 EIP for the three months ended March 31, 2025:

 

   Options
Outstanding
   Weighted
Average
Exercise Price
   Weighted Average
Remaining
Contractual
Life (Years)
   Aggregate
Intrinsic Value
(in thousands)
 
Balance, December 31, 2024   1,628,378   $19.79    8.31   $6,608 
Options granted   609,700   $6.16           
Options cancelled/forfeited   (51,852)  $16.12           
Balance, March 31, 2025   2,186,226   $16.08    8.20   $
 
Vested and expected to vest, March 31, 2025   2,186,226   $16.08    8.20   $
 
Exercisable, March 31, 2025   737,799   $20.29    7.18   $
 

 

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 months ended March 31, 2024 was $0.4 million, and no options were exercised during the three months ended March 31, 2025.

 

The total fair value of options that vested during the three months ended March 31, 2025 and 2024 was $2.7 million and $1.7 million, respectively. The weighted-average grant date fair value of options granted during the three months ended March 31, 2025 and 2024 was $4.92 and $15.17 per share, respectively.

 

Unamortized stock-based compensation expense as of March 31, 2025 was $15.0 million, which is expected to be recognized over a weighted-average period of 2.9 years.

 

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Performance-Based Stock Options 

 

There was no performance-based stock option activity under the 2024 Plan or the 2021 Plan for the three months ended March 31, 2025.

 

   Options
Outstanding
   Weighted
Average
Exercise Price
   Weighted
Average
Remaining
Contractual
Life (Years)
   Aggregate
Intrinsic Value
(in thousands)
 
Balance, December 31, 2024   45,894   $13.95    6.04   $438 
Balance, March 31, 2025   45,894   $13.95    5.80   $
 
Vested and expected to vest, March 31, 2025   45,894   $13.95    5.80   $
 
Exercisable, March 31, 2025   30,893   $7.33    5.18   $
 

 

Restricted Stock Units (RSUs)

 

As of March 31, 2025 and December 31, 2024, the Company had no unvested outstanding RSUs and no RSUs were granted during the three months ended March 31, 2025 and 2024.

 

Performance Restricted Stock Units (PSUs)

 

The following table provides a summary of PSU activity under the 2024 Plan during the three months ended March 31, 2025:

 

   Number of
Share
   Weighted-
Average
Grant Date
Fair Value
 
Unvested performance-based restricted stock units at December 31, 2024   20,000   $21.90 
Granted   
   $  
Unvested performance-based restricted stock units at March 31, 2025   20,000   $21.90 
Outstanding performance-based restricted stock units at March 31, 2025   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%, and vesting term of 2.0 years. Total estimated fair value of $0.4 million was recognized as stock-based compensation expense over 0.4 years, the derived requisite service period from the grant date.

  

Employee Stock Purchase Plans

 

The Company issued no shares of common stock under the 2021 ESPP and the 2024 ESPP during each of the three months ended March 31, 2025 and 2024, and recognized $0.1 million and zero compensation expense related to the 2021 ESPP and the 2024 ESPP during the three months ended March 31, 2025 and 2024, respectively. There was no unamortized stock-based compensation for shares issuable under the 2021 ESPP as of March 31, 2025. There was $0.5 million unamortized stock-based compensation for shares issuable under the 2024 ESPP as of March 31, 2025, which is expected to be recognized over a weighted-average period of 1.3 years. The Company recorded $0.3 million in accrued expenses and other current liabilities related to contributions withheld as of March 31, 2025. 

 

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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
March 31,
 
   2025   2024 
General and administrative  $1,240   $820 
Research and development   571    349 
Total  $1,811   $1,169 

 

The Company recognized zero and less than $0.1 million of stock-based compensation expense related to performance-based options and RSUs during the three months ended March 31, 2025 and 2024, respectively.

 

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
March 31,
   2025  2024
Expected term (in years)  6.016.08  6.046.08
Expected volatility  97.37% – 97.93%  112%
Risk-free interest rate  3.93% – 4.35%  3.93% – 4.27%
Expected dividend yield 
 

 

NOTE 10. 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
March 31,
 
   2025   2024 
Numerator:        
Net loss attributable to common stockholders  $(21,241)  $(13,728)
Denominator:          
Weighted average common shares outstanding   15,022,122    13,439,900 
Less: Shares subject to earnout   
    (105,000)
Weighted average shares used to compute basic and diluted net loss per share   15,022,122    13,334,900 
Net loss per share attributable to common stockholders – basic and diluted  $(1.41)  $(1.03)

 

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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:

 

   March 31, 
   2025   2024 
Outstanding and issued common stock options   2,186,226    1,398,331 
Shares issuable upon exercise of common stock warrants   499,986    499,986 
Unvested performance-based restricted stock units   20,000    
 
Total   2,706,212    1,898,317 

  

NOTE 11. 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 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 three months ended March 31, 2025 and 2024. 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 and accrued expenses related to advisory and consulting services performed by Dr. Shizuru as of each of March 31, 2025 and December 31, 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 utilized to support a broad array of the Company’s systems infrastructure as well as for general information technology support services. For the three months ended March 31, 2025 and 2024, the Company paid that service provider $0.2 million and $0.6 million, respectively, for various information technology support services.

 

NOTE 12. SEGMENT INFORMATION

 

The Company has determined it operates as a single operating and reportable segment, which is the research and development of therapeutic products in the fields of chronic urticaria and asthma. The Company’s chief operating decision maker, its Chief Executive Officer (the “CEO”), manages the Company’s operations on a consolidated basis. The CEO assesses the segments performance and allocates resources based on review of various development, manufacturing and clinical programs expenses, along with the segment’s personnel and general and overhead costs.

 

In addition to the significant expense categories included within net loss presented on the Company's condensed consolidated statements of operations and comprehensive loss, see below for disaggregated amounts that comprise total operating expenses (in thousands):

 

   Three Months Ended
March 31,
 
   2025   2024 
Personnel-related costs  $8,431   $5,880 
General and overhead costs   3,611    3,082 
           
Program costs          
Briquilimab platform   1,957    1,438 
CMO   2,138    1,133 
CSU   2,746    2,135 
Asthma   1,393    
 
CIndU   885    425 
SCID   523    404 
MDS/AML   118    575 
Total program costs   9,760    6,110 
Total operating expense   21,802    15,072 
Other income, net   561    1,344 
Net loss  $(21,241)  $(13,728)

 

All long-lived assets are located in the United States. 

  

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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, 2024 filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2025. 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, 2024, filed with the SEC on February 28, 2025, 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.

 

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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, 2024, filed with the SEC on February 28, 2025, 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.

 

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Overview 

 

We are a clinical-stage biotechnology company focused on developing therapeutics targeting mast cell driven diseases, including Chronic Spontaneous Urticaria (“CSU”), Chronic Inducible Urticaria (“CIndU”) and Asthma. We are evaluating additional indications in mast cell driven diseases for potential future development as well. We have also historically supported development programs in diseases where targeting diseased hemopoietic stem cells can provide benefits, such as 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 throughout the body, including in the lungs and in the skin, which could lead to significant clinical benefit for patients with mast-cell driven diseases such as chronic urticarias. To that end, we are focusing on advancing a portfolio of clinical programs in mast cell driven diseases. Development highlights include:

 

  We commenced the Phase 1b/2a BEACON study in CSU in late 2023 and in January 2025, we presented positive preliminary data as of December 31, 2024 from the first 8 dosing cohorts in the study (10mg, 40mg, 80mg Q8W, 120mg Q8W, 120mg Q12W, 180mg Q8W, 180mg Q12W, and 240mg single-dose). Average patient duration on study as of the cutoff date for the data presented was approximately 28 weeks. Highlights of the data are as follows:

 

  Briquilimab demonstrated a rapid onset of clinical efficacy:

 

  Clinical responses were seen as early as 1 week post-dose; and

 

  Complete responses were observed as early as week 2 post-dose.

 

  Briquilimab drove deep and meaningful clinical responses:

 

  UAS7 reductions of as much as 29 points were noted 4 weeks post-dose (120mg Q12W); and

 

  100% complete responses through 8 weeks were demonstrated at the 240mg dose level.

 

  Dose dependent durability was observed in complete responses and well-controlled disease:

 

  Complete responses showed durability out to:

 

  4 weeks at 120mg;

 

  6 weeks at 180mg; and

 

  8 weeks at 240mg.

 

  Briquilimab was well-tolerated and demonstrated a favorable safety profile:

 

  C-kit related adverse events (“AEs”) were low frequency, transient, low-grade events;

 

  The majority of AEs observed were resolved while on study prior to subsequent doses; and

 

  No dose delays, missed doses or discontinuations were reported due to AEs possibly related to c-Kit blockade.

 

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  We commenced the Phase 1b/2a SPOTLIGHT study in CIndU in early 2024. In October 2024, we presented positive preliminary data on the 40mg and 120mg cohorts from the study showing the following for the 6-week preliminary analysis period following dosing, as follows:

 

  o Across the 40mg and 120mg dosing cohorts in the study, 14 of the 15 participants (93%) achieved a clinical response;

 

  o In the 120mg dose cohort, 10 of 12 participants (83%) experienced a complete response, and 1 participant experienced a partial response; and

 

  o Briquilimab has been well-tolerated in the study, with no serious adverse events (“SAEs”) and no grade 3 or higher AEs reported.

 

  We commenced an Open Label Extension (the “OLE”) study whereby the participants from BEACON and SPOTLIGHT, on study completion, may roll over to the study, to receive 180mg SC briquilimab every 8 weeks.

 

  We commenced a Phase 1b/2a ETESIAN study in Asthma in late 2024.

 

  We are actively evaluating the potential for briquilimab in additional mast cell driven diseases.

 

We have also evaluated briquilimab as a one-time conditioning therapy for severe combined immunodeficiency (“SCID”) patients undergoing a second stem cell transplant for which we conducted a Phase 1/2 clinical trial.

 

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 hematopoietic stem cells.

 

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 continue 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 months ended March 31, 2025 and 2024, we incurred net losses of $21.2 million and $13.7 million, respectively. We generated negative operating cash flows of $22.8 million and $15.7 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $262.1 million.

 

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We had cash and cash equivalents of $48.8 million as of March 31, 2025. 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. In addition, given drug substance and drug product manufacturing and testing with Lonza currently occurs outside the United States, drug product imported into the United States for clinical or commercial use could be subject to significant tariffs in the current political environment.

 

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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.

 

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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;

 

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  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, and 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, Net

 

Other income, net includes foreign currency transactions gains and losses, interest income and change in the fair value of earnout liability. This financial instrument was classified as a liability in our condensed consolidated financial statements and was re-measured at each reporting period end. The earnout liability expired in September 2024 as the common stock price targets were not achieved prior to the expiration of the earnout period.

 

Results of Operations

 

Comparison of the Three Months Ended March 31, 2025 and 2024

 

The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024 (in thousands, except percentages):

 

   Three Months Ended
March 31,
   Change   Change 
   2025   2024   $   % 
Operating expenses                
Research and development  $16,157   $10,298   $5,859    57 
General and administrative   5,645    4,774    871    18 
Total operating expenses   21,802    15,072    6,730    45 
Loss from operations   (21,802)   (15,072)   (6,730)   45 
Interest income   624    1,386    (762)   (55)
Other expense, net   (63)   (42)   (21)   50 
Total other income, net   561    1,344    (783)   (58)
Net loss and comprehensive loss  $(21,241)  $(13,728)  $(7,513)   55 

 

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Research and Development Expenses

 

The following table summarizes our research and development expenses for the periods indicated (in thousands, except percentages):

 

   Three Months Ended
March 31,
   Change   Change 
   2025   2024   $   % 
                 
Personnel-related costs  $4,821   $3,116   $1,705    55 
General and overhead costs   1,576    1,072    504    47 
Program costs   9,760    6,110    3,650    60 
Total research and development expenses  $16,157   $10,298   $5,859    57 

 

Research and development expenses increased by $5.9 million, from $10.3 million for the three months ended March 31, 2024 to $16.2 million for the three months ended March 31, 2025.

 

Personnel-related costs, including employee payroll and related expenses, increased by $1.7 million, from $3.1 million for the three months ended March 31, 2024 to $4.8 million for the three months ended March 31, 2025, as a result of hiring additional employees in our research and development organization. Stock-based compensation expenses, included in personnel-related costs, increased by $0.2 million, from $0.4 million for the three months ended March 31, 2024 to $0.6 million for the three months ended March 31, 2025.

 

Facilities and overhead costs include common facilities, human resources and information technology related expenses allocated to research and development and increased primarily due to and expansion of leased facilities.

 

Program costs increased by $3.7 million, from $6.1 million for the three months ended March 31, 2024 to $9.8 million for the three months ended March 31, 2025. Clinical program expenses increased primarily due to an increase in costs by $1.4 million for the Asthma program that was initiated at the end of 2024 and an increase in costs for the CSU program from $2.1 million for the three months ended March 31, 2024 to $3.0 million for the three months ended March 31, 2025. CMO product development and manufacturing expenses unallocated by programs increased by $1.0 million from $1.1 million for the three months ended March 31, 2024 to $2.1 million for the three months ended March 31, 2025 due to an increase in manufacturing, packaging, and labeling costs to support clinical programs.

 

Our program costs for the three months ended March 31, 2025 and 2024 were as follows (in thousands):

 

   Three Months Ended
March 31,
 
   2025   2024 
Briquilimab platform  $1,957   $1,438 
CMO   2,138    1,133 
CSU   2,746    2,135 
Asthma   1,393     
CIndU   885    425 
SCID   523    404 
MDS/AML   118    575 
Total program costs  $9,760   $6,110 

 

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General and Administrative Expenses

 

General and administrative expenses increased by $0.8 million, from $4.8 million for the three months ended March 31, 2024 to $5.6 million for the three months ended March 31, 2025. Employee payroll and related expenses increased by $0.7 million, from $2.6 million for the three months ended March 31, 2024 to $3.3 million for the three months ended March 31, 2025, as a result of continued hiring of administrative employees. Stock-based compensation expenses, included in employee payroll and related expenses, were $1.2 million and $0.8 million for the three months ended March 31, 2025 and 2024, respectively. Expenses related to professional consulting services increased by $0.2 million, from $1.8 million for the three months ended March 31, 2024 to $2.0 million for the three months ended March 31, 2025. Rent expenses increased by $0.1 million for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024. Other expenses decreased by $0.2 million for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, primarily related to a decrease in allocation of overhead costs of $0.5 million, partially offset by an increase in office licenses and subscriptions expenses of $0.1 million, utilities expenses of $0.1 million and other general administrative expenses of $0.1 million.

 

Total Other Income, Net

 

Total other income, net decreased by $0.8 million, from $1.3 million net income for the three months ended March 31, 2024 to $0.6 million net income for the three months ended March 31, 2025. Interest income decreased by $0.8 million, from $1.4 million for the three months ended March 31, 2024 to $0.6 million for the three months ended March 31, 2025, primarily due to lower cash balances invested in money market funds. Changes in the earnout liability and foreign currency transactions gains and losses were insignificant.

 

Liquidity and Capital Resources

 

As of March 31, 2025, we had $48.8 million of cash and cash equivalents.

 

In order to assist in funding our future operations, including our planned clinical trials, on March 19, 2025, we filed a new universal shelf registration statement on Form S-3 (the “Shelf Registration Statement”) with the SEC, which was declared effective on March 26, 2025 and superseded our prior universal shelf registration statement. As of March 31, 2025, we can sell from time to time up to $300.0 million of common stock, preferred stock, debt securities, warrants, rights, units and depositary shares comprised of any combination of these securities, for our own account in one or more offerings under the Shelf Registration Statement. The terms of any offering under the Shelf Registration Statement will be established at the time of such offering and will be described in a prospectus supplement to the Shelf Registration Statement filed with the SEC prior to the completion of any such offering.

 

In February 2024, we closed an underwritten offering that was conducted off our prior universal shelf registration statement and issued 3,900,000 shares of common stock for net proceeds of $47.2 million.

 

As of March 31, 2025, $100.0 million remains allocated and available under the ATM Prospectus and $200.0 million remains available and unallocated under the Shelf Registration Statement. 

 

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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 March 31, 2025, we had an accumulated deficit of $262.1 million. Given our recurring losses from operations and negative cash flows, and based on our current operating plan, we have concluded that there is substantial doubt about our ability to continue as a going concern within one year from the date of filing of this Quarterly Report. We expect to finance our future cash needs through equity or debt financings, collaborations or a combination of these approaches. The sale of equity or convertible debt securities may result in dilution to our stockholders, and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. Debt financings may subject us to covenant limitations or restrictions on our ability to take specific actions, such as incurring additional debt or making capital expenditures. Our ability to raise additional funds may be adversely impacted by negative global economic conditions and any disruptions to and volatility in the credit and financial markets in the United States and worldwide or other factors. There can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable or acceptable to us. If we are unable to obtain adequate financing when needed or on terms favorable or acceptable to us, we may be forced to delay, reduce the scope of or eliminate one or more of our research and development programs.

 

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;

 

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  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 March 31, 2025.

 

Leases

 

As of March 31, 2025, we leased approximately 25,900 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 March 31, 2025, our rent commitments under the lease agreement were $1.9 million within the next 12 months from March 31, 2025, and $0.8 million for the remainder of the lease term. 

 

Stanford License Agreements

 

In March 2021, we entered into an exclusive license agreement with Stanford (the “2021 Stanford License Agreement ”). In July 2023, we entered into an amendment to the 2021 Stanford License Agreement to modify certain milestones set forth thereunder. Pursuant to the 2021 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 March 31, 2025, and no such royalties were due as of such date and no milestones were achieved. 

 

In December 2024, we entered into a co-exclusive license agreement with Stanford (the “2024 Stanford License Agreement ”). Pursuant to the 2024 Stanford License Agreement, we are required to pay a license issuance fee of $75,000, which was paid in January 2025, and annual license maintenance fees, beginning on the first anniversary of the effective date of the agreement: $25,000 for each of the first through third years, $50,000 for each of the fourth through sixth years and $65,000 at each anniversary thereafter. We are also obligated to pay clinical development milestone payments of up to $1.3 million and sales milestone payments of up to $7.0 million in total. We will also pay low single-digit royalties on net sales of licensed products. All products are in development as of March 31, 2025, and no such royalties were due as of such date and no milestones were achieved.

 

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Cash Flows

 

The following table summarizes our sources and uses of cash for the periods presented (in thousands):

 

   Three Months ended
March 31,
 
   2025   2024 
Net cash used in operating activities  $(22,842)  $(15,736)
Net cash provided by (used in) investing activities   4    (25)
Net cash provided by financing activities       47,349 
Net (decrease) increase in cash and cash equivalents and restricted cash  $(22,838)  $31,588 

 

Cash Flows from Operating Activities

 

Net cash used in operating activities was $22.8 million and $15.7 million for the three months ended March 31, 2025 and 2024, respectively.

 

Cash used in operating activities in the three months ended March 31, 2025 was primarily due to our net loss for the period of $21.2 million, adjusted by non-cash net loss of $2.3 million and a net change of $3.9 million in our net operating assets and liabilities. The non-cash amounts consisted of $1.8 million related to stock-based compensation expense, $0.3 million related to depreciation and amortization expense and $0.2 million of non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to a decrease of $2.6 million in accrued expenses and other current liabilities, a decrease of $1.0 million in accounts payable, a decrease of $0.3 million in operating lease liability, and an increase of $0.2 million in prepaid expenses and other current assets, offset by a decrease of $0.3 million in other non-current assets.

 

Cash used in operating activities in the three months ended March 31, 2024 was primarily due to our net loss for the period of $13.7 million, adjusted by non-cash net loss of $1.6 million and a net change of $3.6 million in our net operating assets and liabilities. The non-cash amounts consisted of $1.2 million related to stock-based compensation expense, $0.3 million related to depreciation and amortization expense, and $0.1 million non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to a decrease of $1.8 million in accounts payable, a decrease of $1.7 million in accrued expenses and other current liabilities, a decrease of $0.2 million in operating lease liability and an increase of $0.1 million in other non-current assets, offset by an increase of $0.2 million in prepaid expenses and other current assets.

 

Cash Flows from Investing Activities

 

Cash used in investing activities was less than $0.1 million for the three months ended March 31, 2025, consisting of sales of property and equipment.

 

Cash used in investing activities was less than $0.1 million for the three months ended March 31, 2024, which consisted of purchases of the computer and lab equipment.

 

Cash Flows from Financing Activities

 

Cash provided by financing activities for the three months ended March 31, 2024 was $47.3 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 $0.2 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, 2024, filed with the SEC on February 28, 2025. Since the date of such financial statements, there have been no material changes to our significant accounting policies.

 

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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.

 

Smaller Reporting Company Status

 

Previously, we were an “emerging growth company,” as defined by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). 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. As of December 31, 2024, we ceased to be an emerging growth company.

 

We are now a “smaller reporting company,” as defined in Item 10(f)(1) of Regulation S-K. Smaller reporting companies may take advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements. We will remain a smaller reporting company until the last day of the fiscal year in which (i) the market value of our common stock held by non-affiliates exceeds $250 million as of the last business day of our second fiscal quarter, or (ii) our annual revenue exceeded $100 million during such completed fiscal year and the market value of our common stock held by non-affiliates exceeds $700 million as of the last business day of our second fiscal quarter.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

There have been no material changes to our market risk during the three months ended March 31, 2025. 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, 2024, filed with the SEC on February 28, 2025.

 

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 SEC’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 SEC 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 March 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

We are 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, 2024, filed with the SEC on February 28, 2025, 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, 2024, filed with the SEC on February 28, 2025. 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 three months ended March 31, 2025 and 2024, we reported net losses of $21.2 million and $13.7 million, respectively. For the three months ended March 31, 2025 and 2024, we reported negative operating cash flows of $22.8 million and $15.7 million, respectively. As of March 31, 2025, we had an accumulated deficit of $262.1 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 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;

 

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  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.

 

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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 March 31, 2025, our cash and cash equivalents were $48.8 million and we had an accumulated deficit of $262.1 million. 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.

 

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We currently have an effective universal shelf registration statement on Form S-3, which we filed with the SEC on March 19, 2025, and which was declared effective on March 26, 2025 and will expire on March 26, 2028 (the “Shelf Registration Statement”). Pursuant to the Shelf Registration Statement, we may offer from time to time up to an aggregate of $300.0 million of securities, including any combination of common stock, preferred stock, debt securities, warrants, rights, units and depositary shares. On March 19, 2025, we entered into an Open Market Sale AgreementSM with Jefferies LLC (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 March 26, 2025, we filed with the SEC a prospectus under the Shelf Registration Statement 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 $100.0 million. No securities had been sold pursuant to the ATM Prospectus as of March 31, 2025.

 

As of May 8, 2025, $100.0 million remains allocated and available under the ATM Prospectus and approximately $200.0 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.

  

As a result of our history of losses and negative cash flows from operations, our management has performed an analysis and concluded that substantial doubt exists about our ability to continue as a going concern, and 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 raises substantial doubt about our ability to continue as a going concern beyond one year from the date of filing of this Quarterly Report. Our financial statements as of March 31, 2025 do not include any adjustments that might result from the outcome of this uncertainty. Based on our current operating plan, we will need to raise additional financing to continue our products’ development for the foreseeable future, and 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. We expect to finance our future cash needs through equity or debt financings, collaborations or a combination of these approaches. The sale of equity or convertible debt securities may result in dilution to our stockholders, and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. Debt financings may subject us to covenant limitations or restrictions on our ability to take specific actions, such as incurring additional debt or making capital expenditures. Our ability to raise additional funds may be adversely impacted by negative global economic conditions and any disruptions to and volatility in the credit and financial markets in the United States and worldwide or other factors. There can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable or acceptable to us. If we are unable to obtain adequate financing when needed or on terms favorable or acceptable to us, we may be forced to delay, reduce the scope of or eliminate one or more of our research and development programs.

 

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.

 

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Risks Related to Discovery, Development, Manufacturing and Commercialization

 

Delays in the commencement or completion of clinical trials could result in increased costs to us and delay our ability to establish strategic collaborations.

 

Delays in the commencement or completion of clinical trials could significantly impact our drug development costs. We do not know whether planned clinical trials will begin on time or be completed on schedule, if at all. The commencement of clinical trials can be delayed for a variety of reasons, including, but not limited to, delays related to:

 

  obtaining regulatory approval to commence one or more clinical trials;

 

  reaching agreement on acceptable terms with prospective CROs and clinical trial sites;

 

  manufacturing sufficient quantities of a product candidate or other materials necessary to conduct clinical trials, as well as receiving the supplies and materials needed to conduct our clinical trials, including interruptions in global shipping that may affect the transport of clinical materials;

 

  manufacturing sufficient quantities of a product candidate or other materials necessary to conduct clinical trials, as well as receiving the supplies and materials needed to conduct our clinical trials, including interruptions in global shipping that may affect the transport of clinical materials;

 

  unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements, which may negatively impact the supply chain or cause other disruptions;

 

  obtaining institutional review board approval to conduct one or more clinical trials at a prospective site;

 

  recruiting and enrolling patients to participate in one or more clinical trials, especially as patients may be reluctant or unable to visit clinical sites, or may delay seeking treatment for chronic conditions;

 

  the failure of our collaborators to adequately resource our product candidates due to their focus on other programs or as a result of general market conditions;

 

  recruiting clinical site investigators, clinical site staff and potential closure of clinical facilities; and

 

  changes in regulations, which may require us to change the ways in which our clinical trials are conducted.

 

In addition, once a clinical trial has begun, it may be suspended or terminated by us, our collaborators, the institutional review boards or data safety monitoring boards charged with overseeing our clinical trials, the FDA, EMA or comparable foreign authorities due to a number of factors, including:

 

  failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols;

 

  inspection of the clinical trial operations or clinical trial site by the FDA, EMA or comparable foreign authorities resulting in the imposition of a clinical hold;

 

  unforeseen safety issues; or

 

  lack of adequate funding to continue the clinical trial.

 

If we experience delays in the completion or termination of any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to commence product sales and generate product revenues from any of our product candidates will be delayed. In addition, any delays in completing our clinical trials will increase our costs and slow down our product candidate development and approval process. Delays in completing our clinical trials could also allow our competitors to obtain marketing approval before we do or shorten the patent protection period during which we may have the exclusive right to commercialize our product candidates. Any of these occurrences may harm our business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

 

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If we experience delays or difficulties in the enrollment of patients in clinical trials, the cost of developing product candidates could increase and our receipt of necessary regulatory approvals could be delayed or prevented.

 

Patient enrollment is a significant factor in the timing of clinical trials. The timing of our clinical trials depends, in part, on the speed at which we can recruit patients to participate in our trials. We or our collaborators may not be able to continue clinical trials for briquilimab or any other product candidates we identify or develop if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA, the EMA or other analogous regulatory authorities outside the United States, or as needed to provide appropriate statistical power for a given trial. Patients may be unwilling to participate in our clinical trials because of negative publicity from adverse events related to the biotechnology competitive clinical trials for similar patient populations, clinical trials in competing products or for other reasons. As a result, the timeline for recruiting patients, conducting trials and obtaining regulatory approval of product candidates may be delayed.

 

Patient enrollment is also affected by other factors, including:

 

  severity of the disease under investigation;

 

  size of the patient population and process for identifying patients;

 

  design of the trial protocol;

 

  availability and efficacy of approved medications for the disease under investigation;

 

  availability of genetic testing for potential patients;

 

  ability to obtain and maintain patient informed consent;

 

  risk that enrolled patients will drop out before completion of the trial;

 

  eligibility and exclusion criteria for the trial in question;

 

  perceived risks and benefits of the product candidate under trial;

 

  perceived risks and benefits of the companion therapeutics that may be administered in combination or in sequence with briquilimab;

 

  efforts to facilitate timely enrollment in clinical trials;

 

  patient referral practices of physicians;

 

  ability to monitor patients adequately during and after treatment;

 

  proximity and availability of clinical trial sites for prospective patients, especially for those conditions that have small patient pools;

 

  the requirement for HCT to be performed in centers that specialize in this procedure;

 

  changes to diagnostic technologies, methodologies or criteria used to identify HCT patients at high risk for relapse; and
     
  other factors outside of our control, such as overall economic conditions and volatility in the credit and financial markets, tariffs imposed by the U.S. and other countries, inflationary pressures, trade wars, the Russian invasion of Ukraine, the Israel-Hamas war, the conflict between Israel and Iran and other geopolitical conflicts.

 

In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us because some patients who have opted to enroll in our trials may instead opt to enroll in a trial being conducted by a competitor. We may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites.

 

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Enrollment delays in our clinical trials may result in increased development costs for briquilimab or any other product candidates we may develop, which would cause the value of our company to decline and limit our ability to obtain additional financing. If we or our collaborators have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business, financial condition, results of operations and prospects.

 

Risks Related to Regulatory Review

 

Disruptions at the FDA, the SEC and other government agencies, including from government shutdowns, or funding changes, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

 

The ability of the FDA to review and approve new products, to provide feedback on clinical trials and development programs, to meet with sponsors and to otherwise review regulatory submissions can be affected by a variety of factors, including government budget and funding levels, reductions in workforce, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. In the past, average review times at the agency have fluctuated, and this may continue in the future. In addition, government funding of other agencies on which our operations may rely is subject to the political process, which is inherently fluid and unpredictable. In addition, government shutdowns, if prolonged, could significantly impact the ability of government agencies upon which rely (such as the FDA and the SEC) to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

 

Disruptions at the FDA and other agencies may slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the past decade, the U.S. government has shut down several times, and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue to fund our operations.

 

Finally, with the change in presidential administrations in 2025, there is substantial uncertainty as to how, if at all, the new administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates. The impending uncertainty could present new challenges or potential opportunities as we navigate the clinical development and approval process for our product candidates. If we or our collaborators experience delays in obtaining approval or if we or they fail to obtain approval of our product candidates, the commercial prospects for our product candidates may be harmed and our ability to generate revenue will be materially impaired.

 

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 March 31, 2025, we had 60 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, the 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.

 

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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.

 

Unstable market and economic conditions may have serious adverse consequences on our business and financial condition.

 

Our business, financial condition and results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. A severe or prolonged economic downturn could result in a variety of risks to our business, including our ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain our suppliers, service providers, manufacturers or other partners and there is a risk that one or more would not survive or be able to meet their commitments to us under such circumstances. There can be no assurances that deterioration in the credit and financial markets and confidence in economic conditions will not occur.

 

For example, U.S. debt ceiling and budget deficit concerns have increased the possibility of additional credit-rating downgrades and economic slowdowns, or a recession in the United States. Although U.S. lawmakers passed legislation to raise the federal debt ceiling on multiple occasions, including a suspension of the federal debt ceiling in June 2023, ratings agencies have lowered or threatened to lower the long-term sovereign credit rating on the United States. The impact of this or any further downgrades to the U.S. government’s sovereign credit rating or its perceived creditworthiness could adversely affect the U.S. and global financial markets and economic conditions. Absent further quantitative easing by the Federal Reserve, these developments could cause interest rates and borrowing costs to rise, which may negatively impact our results of operations or financial condition. Moreover, disagreement over the federal budget has caused the U.S. federal government to shut down for periods of time. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

 

Furthermore, the new U.S. administration has substantially departed from prior U.S. government international trade policies and has commenced activities to renegotiate, or potentially terminate, certain existing bilateral or multi-lateral trade agreements and treaties with foreign countries. In addition, the new U.S. administration has initiated or is considering imposing tariffs on certain foreign goods. Related to this action, certain foreign governments, including China, have instituted or are considering imposing reciprocal tariffs on certain U.S. goods. It remains unclear what the new U.S. administration or foreign governments will or will not do with respect to tariffs or other international trade agreements and policies. A trade war or other governmental action related to tariffs or international trade agreements or policies has the potential to disrupt our research activities, affect our suppliers, increase the cost of materials purchased to manufacture our products, impact our ability to sell our products outside the United States or to sell our products outside the United States at competitive prices and/or to affect the United States or global economy or certain sectors thereof and, thus, could adversely impact our business and financial condition.

 

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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;

 

41

 

 

  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 2, 2024 to December 31, 2024, our closing stock price ranged from $6.63 to $30.00 per share. From January 2, 2025 to May 8, 2025, our closing stock price ranged from $3.47 to $21.09 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 March 31, 2025, our directors and executive officers and their affiliates beneficially owned approximately 20.6% 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 2024 Plan and the 2024 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.

 

42

 

 

Pursuant to the Jasper Therapeutics, Inc. 2024 Equity Incentive Plan (the “2024 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 “2024 ESPP”), which became effective on June 6, 2024, we are authorized to sell shares to our employees. As of March 31, 2025, 1,199,754 shares and 981,370 shares of our common stock are reserved for future issuance under the 2024 Plan and the 2024 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 March 31, 2025, 50,574 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 March 31, 2025, options to purchase an aggregate of 2,186,226 shares of our common stock and 20,000 performance-based restricted stock units were outstanding.

 

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 March 31, 2025, none of our directors or officers (as defined in Section 16 of the Exchange Act) 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.

 

43

 

 

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, dated September 24, 2021.   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. 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   Open Market Sale AgreementSM, dated as of March 19, 2025, by and between Jasper Therapeutics, Inc. and Jefferies LLC.   S-3   3/19/2025   1.2
                 
31.1*   Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.            
                 
31.2*   Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934.            
                 
32.1**   Certification of the Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.            
                 
101.INS*   Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.            
                 
101.SCH*   Inline XBRL Taxonomy Extension Schema Document.            
                 
101.CAL*   Inline XBRL Taxonomy Extension Calculation Linkbase Document.            
                 
101.DEF*   Inline XBRL Taxonomy Extension Definition Linkbase Document.            
                 
101.LAB*   Inline XBRL Taxonomy Extension Label Linkbase Document.            
                 
101.PRE*   Inline XBRL Taxonomy Extension Presentation Linkbase Document.            
                 
104*   Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).            

 

* Filed herewith.

 

** Furnished herewith.

 

44

 

 

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: May 12, 2025 By: /s/ Ronald Martell
    Ronald Martell
    President and Chief Executive Officer
    (Principal Executive Officer)
   
Date: May 12, 2025 By: /s/ Herb Cross 
    Herb Cross 
    Chief Financial Officer
    (Principal Accounting and Financial Officer)

 

 

45

 

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