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Jasper Therapeutics, Inc.

For the period ended Sep 30, 2025. Filed Nov 10, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 10, 2025

JSPR$16.86+19.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-13.

0001213900-25-075635

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-10.

0001213900-25-107884

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 111 previous paragraphs and 126 current paragraphs.

73 unchanged; 29 reworded; 19 added; 8 removed; 1 previous and 5 current paragraphs rearranged.

Tables are not compared: 95 previous and 88 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (19)

Current report

In September 2025, we provided an update on the ongoing investigation into the confounded efficacy results reported in July 2025 from the 240mg Q8W and the 240mg followed by 180mg Q8W cohorts of the BEACON study in CSU. Based on the work conducted to date, we believe the anomalous efficacy results in these two cohorts do not appear to be related to drug substance (“DS”) or drug product (“DP”) manufacturing or distribution processes. This conclusion reflects, among other factors:

Current report

With no evidence of DS or DP issues, the ongoing investigation is now focused on clinical site activity, including:

Current report

We continue to expect to complete the investigation in the fourth quarter of 2025, supported by a key opinion leader panel that will review findings and provide clinical and chemistry, manufacturing and controls recommendations for integration into the planned Phase 2b CSU study.

Current report

On September 18, 2025, we entered into an underwriting agreement with TD Securities (USA) LLC as the representative of the several underwriters named therein, relating to an underwritten public offering. On September 22, 2025, we closed the offering and issued an aggregate of 11,670,707 shares of common stock, pre-funded warrants to purchase 675,000 shares of common stock and common warrants to purchase 12,345,707 shares of common stock for net proceeds of $27.5 million.

Current report

Research and development expenses decreased by $0.1 million, from $14.5 million for the three months ended September 30, 2024 to $14.4 million for the three months ended September 30, 2025.

Current report

Program costs increased by $0.5 million, from $8.8 million for the three months ended September 30, 2024 to $9.3 million for the three months ended September 30, 2025. Clinical program expenses primarily consisted of expenses incurred under agreements with CROs, consultants, other professional services, in vivo study costs and lab supplies. Clinical program expenses increased primarily due to an increase in CRO expenses of $0.8 million from $3.6 million for the three months ended September 30, 2024 to $4.4 million for the three months ended September 30, 2025 and an increase in the preclinical in vivo study costs of $0.9 million from $0.1 million for the nine months ended September 30, 2024 to $1.0 million for the nine months ended September 30, 2025, partially offset by a decrease in external consultant and other professional services costs of $0.8 million and lab supply costs of $0.2 million.

Current report

General and administrative expenses decreased by $0.6 million, from $5.4 million for the three months ended September 30, 2024 to $4.8 million for the three months ended September 30, 2025. Employee payroll and related expenses increased by $0.3 million, from $3.0 million for the three months ended September 30, 2024 to $3.3 million for the three months ended September 30, 2025, primarily due to severance-related costs associated with the corporate reorganization implemented in July 2025. Stock-based compensation expenses, included in employee payroll and related expenses, were $1.0 million and $1.1 million for the three months ended September 30, 2025 and 2024, respectively. Expenses related to legal and other professional services decreased by $0.8 million, from $2.0 million for the three months ended September 30, 2024 to $1.2 million for the three months ended September 30, 2025, primarily due to a decrease of stock-based compensation expenses related to non-employees of $0.4 million and a decrease in recruiting, accounting, audit, tax and other professional service costs of $0.4 million.

Current report

The change in fair value of warrant liability of $2.1 million represents a decrease in the fair value of common warrants from the issuance date of September 22, 2025 to September 30, 2025.

Current report

Offering costs of $2.0 million associated with the warrant liability were expensed and included in other expense, net for the three months ended September 30, 2025.

Current report

Comparison of the Nine Months Ended September 30, 2025 and 2024

Current report

Research and development expenses increased by $15.7 million, from $36.1 million for the nine months ended September 30, 2024 to $51.7 million for the nine months ended September 30, 2025.

Current report

Total other income, net decreased by $2.7 million, from $4.0 million for the nine months ended September 30, 2024 to $1.3 million for the nine months ended September 30, 2025.

Current report

The change in fair value of warrant liability of $2.1 million represents a decrease in the fair value of common warrants from the issuance date of September 22, 2025 to September 30, 2025.

Current report

Offering costs of $2.0 million associated with the warrant liability were expensed and included in other expense, net for the nine months ended September 30, 2025.

Current report

On September 18, 2025, we entered into an underwriting agreement with TD Securities (USA) LLC as the representative of the several underwriters named therein, relating to an underwritten public offering under the Shelf Registration Statement. On September 22, 2025, we closed the offering and issued an aggregate of 11,670,707 shares of common stock, pre-funded warrants to purchase 675,000 shares of common stock and common stock warrants to purchase 12,345,707 shares of common stock, for net proceeds of approximately $27.5 million.

Current report

We account for issued warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance included in ASC 480,Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815,Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, whether the warrants meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent reporting period end date while the warrants are outstanding. Warrants that meet all of the criteria for equity classification are required to be recorded as a component of additional paid-in capital at the time of issuance, or when the conditions for equity classification are met and are not subsequently remeasured. Warrants that do not meet the required criteria for equity classification are classified as liabilities at fair value. The warrants are subsequently remeasured at each reporting date with changes in fair value recorded in the consolidated statements of operations and comprehensive loss until exercise or expiration.

Current report

We use the Black-Scholes pricing model to determine the fair value of warrant liability. Inputs used to determine estimated fair value of the warrant liability include the fair value of the underlying stock at the valuation date, the term of the warrants, and the expected volatility of the underlying stock. The significant unobservable input used in the fair value measurement of the warrant liability is the estimated term of the warrants. The estimates of fair value are uncertain and changes in any of the estimated inputs used as of the date of this report could have resulted in significant adjustments to the fair value.
Removed paragraphs (8)

Previous report

The total cost related to the workforce reduction is estimated to be approximately $1.9 million, all of which is cash-based expenditure related primarily to severance payments. We expect to recognize substantially all the charges related to the workforce reduction in the quarter ending September 30, 2025. These estimates are subject to a number of assumptions and actual results may differ. We may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the corporate reorganization.

Previous report

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.

Previous report

Research and development expenses increased by $9.9 million, from $11.3 million for the three months ended June 30, 2024 to $21.2 million for the three months ended June 30, 2025.

Previous report

Research and development expenses increased by $15.8 million, from $21.6 million for the six months ended June 30, 2024 to $37.4 million for the six months ended June 30, 2025.

Previous report

General and administrative expenses increased by $2.0 million, from $9.5 million for the six months ended June 30, 2024 to $11.5 million for the six months ended June 30, 2025. Employee payroll and related expenses increased by $1.1 million, from $5.3 million for the six months ended June 30, 2024 to $6.4 million for the six months ended June 30, 2025, as a result of continued hiring of administrative employees. Stock-based compensation expenses, included in employee payroll and related expenses, were $2.0 million and $1.6 million for the six months ended June 30, 2025 and 2024, respectively. Expenses related to professional consulting services increased by $1.1 million, from $3.4 million for the six months ended June 30, 2024 to $4.5 million for the six months ended June 30, 2025. Rent expenses increased by $0.2 million for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024. Other expenses decreased by $0.5 million for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024, primarily related to a decrease in allocation of overhead costs of $0.8 million and a decrease of patent-related costs $0.1 million, partially offset by an increase in office licenses and subscriptions expenses of $0.2 million and an increase in utilities expenses of $0.2 million.

Previous report

Total other income, net decreased by $1.9 million, from $2.8 million for the six months ended June 30, 2024 to $0.9 million for the six months ended June 30, 2025. Interest income decreased by $1.8 million, from $2.8 million for the six months ended June 30, 2024 to $1.0 million for the six months ended June 30, 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.
Reworded paragraphs (29)

Previous wording

Historically, 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 as well as via Investigator Sponsored Trials (“ISTs”) in several other stem cell transplant indications. As of July 2025, the SCID program and any remaining ISTs are being immediately discontinued to focus resources exclusively on our mast cell disease development programs.

Current wording

Historically, 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 as well as via Investigator Sponsored Trials (“ISTs”) in several other stem cell transplant indications. In July 2025, the SCID program and any remaining ISTs were discontinued to focus resources exclusively on our mast cell disease development programs.

Previous wording

On July 8, 2025, we implemented a corporate reorganization to extend our cash runway, including a workforce reduction of approximately 50% of our employees at that time. In connection with this corporate reorganization, we refined our operating plan to focus on our briquilimab clinical development programs in chronic urticaria and halted enrollment in our Phase 1b/2a ETESIAN study in asthma and halted our other clinical and preclinical programs.

Current wording

On July 8, 2025, we implemented a corporate reorganization to extend our cash runway, including a workforce reduction of approximately 50% of our workforce, representing 20 employees. The reorganization was substantially completed during the third quarter of 2025. In connection with this corporate reorganization, we refined our operating plan to focus on our briquilimab clinical development programs in chronic urticaria and halted enrollment in our Phase 1b/2a ETESIAN study in asthma and halted our other clinical and preclinical programs. The total cost related to the workforce reduction was approximately $1.8 million, all of which represented cash-based expenditure related primarily to severance payments. For each of the three and nine month periods ended September 30, 2025, we recorded restructuring charges of $1.3 million and $0.5 million as research and development expenses and general and administrative expenses, respectively, in our condensed consolidated statements of operations and comprehensive loss.

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. During the three and six months ended June 30, 2025 we incurred net losses of $26.7 million and $48.0 million, respectively. During the three and six months ended June 30, 2024 we incurred net losses of $14.6 million and $28.3 million, respectively. We generated negative operating cash flows of $38.3 million and $27.4 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $288.8 million.

Current wording

We have incurred significant losses and negative cash flows from operations since our inception. During the three and nine months ended September 30, 2025 we incurred net losses of $18.7 million and $66.7 million, respectively. During the three and nine months ended September 30, 2024 we incurred net losses of $18.6 million and $46.9 million, respectively. We generated negative operating cash flows of $55.3 million and $41.5 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $307.6 million.

Previous wording

We had cash and cash equivalents of $39.5 million as of June 30, 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.

Current wording

We had cash and cash equivalents of $50.9 million as of September 30, 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.

Previous wording

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.

Current wording

Total other income, net includes foreign currency transactions gains and losses, interest income, offering costs on the common warrants recognized as other expense, and changes in the fair value of earnout liability and warrant liability. Earnout liability and warrant liability were classified as a liabilities in our condensed consolidated financial statements and were 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.

Previous wording

Personnel-related costs, including employee payroll and related expenses, increased by $0.1 million, from $3.8 million for the three months ended June, 2024 to $3.9 million for the three months ended June 30, 2025. Stock-based compensation expenses, included in personnel-related costs, increased by $0.1 million, from $0.4 million for the three months ended June 30, 2024 to $0.5 million for the three months ended June 30, 2025.

Current wording

Personnel-related costs, including employee payroll and related expenses, decreased by $0.2 million, from $4.0 million for the three months ended September 30, 2024 to $3.8 million for the three months ended September 30, 2025, primarily due to the workforce reduction as part of the corporate reorganization implemented in July 2025. Stock-based compensation expenses, included in personnel-related costs, decreased by $0.1 million, from $0.6 million for the three months ended September 30, 2024 to $0.5 million for the three months ended September 30, 2025.

Previous wording

General and overhead costs include common facilities, human resources and information technology related expenses allocated to research and development and increased by $0.7 million, from $2.4 million for the six months ended June 30, 2024 to $3.1 million for the six months ended June 30, 2025, primarily due to and expansion of leased facilities.

Current wording

General and overhead costs, which include common facilities, human resources and information technology related expenses allocated to research and development, decreased by $0.4 million, from $1.7 million for the three months ended September 30, 2024 to $1.3 million for the three months ended September 30, 2025, primarily due to the corporate reorganization in July 2025.

Previous wording

Program costs increased by $9.6 million, from $6.2 million for the three months ended June 30, 2024 to $15.8 million for the three months ended June 30, 2025. Clinical program expenses primarily consisted of expenses incurred under agreements with CROs, consultants, other professional services, in vivo study costs and lab supplies. Clinical program expenses increased primarily due to an increase in CRO expenses of $4.1 million from $1.7 million for the three months ended June 30, 2024 to $5.8 million for the three months ended June 30, 2025. At the program level, the increase in clinical program expenses was primarily driven by an increase in costs for the CSU program of $2.2 million from $1.9 million for the three months ended June 30, 2024 to $4.1 million for the three months ended June 30, 2025, an increase in costs of $1.8 million for the asthma program that was initiated at the end of 2024 and an increase in costs for the Briquilimab platform of $0.6 million from $1.3 million for the three months ended June 30, 2024 to $1.9 million for the three months ended June 30, 2025. CMO product development and manufacturing expenses unallocated by programs increased by $5.1 million from $1.4 million for the three months ended June 30, 2024 to $6.5 million for the three months ended June 30, 2025 due to an increase in manufacturing, packaging, and labeling costs to support clinical programs.

Current wording

At the program level, the increase in clinical program expenses was primarily driven by an increase in costs for the CSU program of $0.3 million from $2.6 million for the three months ended September 30, 2024 to $2.9 million for the three months ended September 30, 2025, an increase in costs for the SCID program of $0.3 million from $0.6 million for the three months ended September 30, 2024 to $0.9 million for the three months ended September 30, 2025 and an increase in costs for the CIndU program of $0.2 million from $0.5 million for the three months ended September 30, 2024 to $0.7 million for the three months ended September 30, 2025, partially offset by decrease in costs for the MDS/AML platform of $0.5 million. CMO product development and manufacturing expenses unallocated by programs increased by $0.2 million from $2.4 million for the three months ended September 30, 2024 to $2.6 million for the three months ended September 30, 2025 due to an increase in manufacturing, packaging, and labeling costs to support clinical programs.

Previous wording

Total other income, net decreased by $1.0 million, from $1.4 million for the three months ended June 30, 2024 to $0.4 million for the three months ended June 30, 2025. Interest income decreased by $1.1 million, from $1.5 million for the three months ended June 30, 2024 to $0.4 million for the three months ended June 30, 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.

Current wording

Interest income decreased by $1.0 million, from $1.3 million for the three months ended September 30, 2024 to $0.3 million for the three months ended September 30, 2025, primarily due to lower cash balances invested in money market funds.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands, except percentages):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands, except percentages):

Previous wording

Personnel-related costs, including employee payroll and related expenses, increased by $1.8 million, from $6.9 million for the six months ended June, 2024 to $8.7 million for the six months ended June 30, 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 $0.4 million, from $0.7 million for the six months ended June 30, 2024 to $1.1 million for the six months ended June 30, 2025.

Current wording

Personnel-related costs, including employee payroll and related expenses, increased by $1.6 million, from $10.9 million for the nine months ended September 30, 2024 to $12.5 million for the nine months ended September 30, 2025, as a result of hiring additional employees in our research and development organization before the corporate reorganization in July 2025. Stock-based compensation expenses, included in personnel-related costs, increased by $0.3 million, from $1.3 million for the nine months ended September 30, 2024 to $1.6 million for the nine months ended September 30, 2025.

Previous wording

General and overhead costs include common facilities, human resources and information technology related expenses allocated to research and development and increased by $0.2 million, from $1.3 million for the three months ended June 30, 2024 to $1.5 million for the three months ended June 30, 2025, primarily due to and expansion of leased facilities.

Current wording

General and overhead costs, which include common facilities, human resources and information technology related expenses allocated to research and development, increased by $0.4 million, from $4.0 million for the nine months ended September 30, 2024 to $4.4 million for the nine months ended September 30, 2025, primarily due to an expansion of leased facilities.

Previous wording

Program costs increased by $13.2 million, from $12.3 million for the six months ended June 30, 2024 to $25.5 million for the six months ended June 30, 2025. Clinical program expenses primarily consisted of expenses incurred under agreements with CROs, consultants, other professional services, in vivo study costs and lab supplies. Clinical program expenses increased primarily due to an increase in CRO expenses of $5.7 million from $4.1 million for the six months ended June 30, 2024 to $9.8 million for the six months ended June 30, 2025 and an increase in in vivo study costs of $1.6 million from $0.1 million for the six months ended June 30, 2024 to $1.7 million for the six months ended June 30, 2025. At the program level, the increase in clinical program expenses was primarily driven by an increase in costs for the CSU program of $2.8 million from $4.1 million for the six months ended June 30, 2024 to $6.8 million for the six months ended June 30, 2025, an increase in costs by $3.2 million for the asthma program that was initiated at the end of 2024 and an increase in costs for the Briquilimab platform of $1.1 million from $2.7 million for the three months ended June 30, 2024 to $3.8 million for the three months ended June 30, 2025. CMO product development and manufacturing expenses unallocated by programs increased by $6.1 million from $2.6 million for the six months ended June 30, 2024 to $8.7 million for the six months ended June 30, 2025 due to an increase in manufacturing, packaging, and labeling costs to support clinical programs.

Current wording

At the program level, the increase in clinical program expenses was primarily driven by an increase in costs for the CSU program of $3.1 million from $6.7 million for the nine months ended September 30, 2024 to $9.8 million for the nine months ended September 30, 2025, an increase in costs by $3.1 million for the asthma program that was initiated at the end of 2024 and an increase in costs for the Briquilimab platform of $1.3 million from $4.1 million for the nine months ended September 30, 2024 to $5.4 million for the nine months ended September 30, 2025. CMO product development and manufacturing expenses unallocated by programs increased by $6.3 million from $5.0 million for the nine months ended September 30, 2024 to $11.3 million for the nine months ended September 30, 2025 due to an increase in manufacturing, packaging, and labeling costs to support clinical programs.

Previous wording

Our program costs for the six months ended June 30, 2025 and 2024 were as follows (in thousands):

Current wording

Our program costs for the nine months ended September 30, 2025 and 2024 were as follows (in thousands):

Previous wording

General and administrative expenses increased by $1.2 million, from $4.7 million for the three months ended June 30, 2024 to $5.9 million for the three months ended June 30, 2025. Employee payroll and related expenses increased by $0.4 million, from $2.7 million for the three months ended June 30, 2024 to $3.1 million for the three months ended June 30, 2025, as a result of continued hiring of administrative employees. Stock-based compensation expenses, included in employee payroll and related expenses, were $1.0 million and $0.9 million for the three months ended June 30, 2025 and 2024, respectively. Expenses related to legal and other professional services increased by $0.9 million, from $1.6 million for the three months ended June 30, 2024 to $2.5 million for the three months ended June 30, 2025. Rent expenses increased by $0.1 million for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024. Other expenses decreased by $0.3 million for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024, primarily related to a decrease in allocation of overhead costs of $0.3 million.

Current wording

General and administrative expenses increased by $1.4 million, from $14.9 million for the nine months ended September 30, 2024 to $16.3 million for the nine months ended September 30, 2025. Employee payroll and related expenses increased by $1.5 million, from $8.2 million for the nine months ended September 30, 2024 to $9.7 million for the nine months ended September 30, 2025, due to severance-related costs associated with the corporate reorganization implemented in July 2025 and hiring of administrative employees before the corporation reorganization. Stock-based compensation expenses, included in employee payroll and related expenses, were $3.0 million and $2.7 million for the nine months ended September 30, 2025 and 2024, respectively. Expenses related to professional consulting services increased by $0.4 million, from $5.3 million for the nine months ended September 30, 2024 to $5.7 million for the nine months ended September 30, 2025. Rent expenses increased by $0.3 million for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024. Other expenses decreased by $0.8 million for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024, primarily related to a decrease in allocation of overhead costs of $0.4 million and a decrease of patent-related costs of $0.3 million.

Previous wording

As of June 30, 2025, we had $39.5 million of cash and cash equivalents.

Current wording

As of September 30, 2025, we had $50.9 million of cash and cash equivalents.

Previous wording

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 June 30, 2025, we can sell from time to time up to $294.1 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.

Current wording

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 September 30, 2025, we can sell from time to time up to $263.5 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.

Previous wording

On March 19, 2025, we entered into an Open Market Sale Agreement SM with Jefferies LLC (“Jefferies”), pursuant to which we 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, we filed with the SEC a prospectus under the New S-3 in connection with the ATM Offering (the “ATM Prospectus”), pursuant to which we may offer and sell shares of common stock having an aggregate offering price of up to $100.0 million. As of June 30, 2025, we issued and sold an aggregate of 1,137,358 shares of common stock for net proceeds of approximately $5.9 million pursuant to the ATM Prospectus.

Current wording

On March 19, 2025, we entered into an Open Market Sale Agreement SM with Jefferies LLC (“Jefferies”), pursuant to which we 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, we filed with the SEC a prospectus under the New S-3 in connection with the ATM Offering (the “ATM Prospectus”), pursuant to which we may offer and sell shares of common stock having an aggregate offering price of up to $100.0 million. As of September 30, 2025, we issued and sold an aggregate of 1,231,447 shares of common stock for net proceeds of approximately $6.5 million pursuant to the ATM Prospectus.

Previous wording

As of June 30, 2025, $94.1 million remains allocated and available under the ATM Prospectus and $200.0 million remains available and unallocated under the Shelf Registration Statement.

Current wording

As of September 30, 2025, $93.5 million remains allocated and available under the ATM Prospectus and $170.0 million remains available and unallocated under the Shelf Registration Statement.

Previous wording

We have incurred significant losses and negative cash flows from operations since our inception. As of June 30, 2025, we had an accumulated deficit of $288.8 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.

Current wording

We have incurred significant losses and negative cash flows from operations since our inception. As of September 30, 2025, we had an accumulated deficit of $307.6 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.

Previous wording

As of June 30, 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 June 30, 2025, our rent commitments under the lease agreement were $2.0 million within the next 12 months from June 30, 2025, and $0.2 million for the remainder of the lease term.

Current wording

As of September 30, 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 September 30, 2025, our rent commitments under the lease agreement were $1.8 million within the next 12 months from September 30, 2025.

Previous wording

Net cash used in operating activities was $38.3 million and $27.4 million for the six months ended June 30, 2025 and 2024, respectively.

Current wording

Net cash used in operating activities was $55.3 million and $41.5 million for the nine months ended September 30, 2025 and 2024, respectively.

Previous wording

Cash used in operating activities in the six months ended June 30, 2024 was primarily due to our net loss for the period of $28.3 million, adjusted by non-cash net loss of $3.5 million and a net change of $2.6 million in our net operating assets and liabilities. The non-cash amounts consisted of $2.7 million related to stock-based compensation expense, $0.6 million related to depreciation and amortization expense, and $0.2 million non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to a decrease of $1.3 million in accounts payable, a decrease of $1.2 million in accrued expenses and other current liabilities, a decrease of $0.5 million in operating lease liability, offset by a decrease of $0.2 million in prepaid expenses and other current assets and a decrease of $0.2 million in other non-current assets.

Current wording

Cash used in operating activities in the nine months ended September 30, 2025 was primarily due to our net loss for the period of $66.7 million partially offset by non-cash items totaling $6.6 million and a net change of $4.8 million in our net operating assets and liabilities. The non-cash items consisted of $5.1 million related to stock-based compensation expense, $2.0 million related to offering costs recognized as expense, $0.8 million related to depreciation and amortization expense and $0.8 million of non-cash lease expense, partially offset by change in fair value of warrant liability of $2.1 million. The changes in our net operating assets and liabilities were primarily due to an increase of $5.1 million in accounts payable, a decrease of $0.7 million in other non-current assets, an increase of $0.3 million in accrued expenses and other current liabilities, and a decrease of $0.5 million in prepaid expenses and other current assets, partially offset by a decrease of $1.2 million in operating lease liability and a decrease of $0.3 million in accrued expenses and other current liabilities.

Previous wording

Cash used in operating activities in the six months ended June 30, 2025 was primarily due to our net loss for the period of $48.0 million partially offset by non-cash items totaling $4.7 million and a net change of $5.0 million in our net operating assets and liabilities. The non-cash items consisted of $3.6 million related to stock-based compensation expense, $0.5 million related to depreciation and amortization expense and $0.5 million of non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to an increase of $4.0 million in accounts payable, a decrease of $0.7 million in prepaid expenses and other current assets, a decrease of $0.6 million in other non-current assets and an increase of $0.4 million in accrued expenses and other current liabilities, partially offset by a decrease of $0.8 million in operating lease liability.

Current wording

Cash used in operating activities in the nine months ended September 30, 2024 was primarily due to our net loss for the period of $46.9 million and a net change of $0.7 million in our net operating assets and liabilities, partially offset by non-cash net loss of $6.1 million. The non-cash amounts consisted of $4.6 million related to stock-based compensation expense, $1.1 million related to depreciation and amortization expense and $0.4 million of non-cash lease expense. The changes in our net operating assets and liabilities were primarily due to a decrease of $1.1 million in accounts payable, a decrease of $0.7 million in operating lease liability and an increase of $0.3 million in prepaid expenses and other current assets, offset by an increase of $1.1 million in accrued expenses and other current liabilities and a decrease of $0.3 million in other non-current assets.

Previous wording

Cash provided by investing activities was less than $0.1 million for the six months ended June 30, 2025, which primarily consisted of proceeds from sales of property and equipment.

Current wording

Cash provided by investing activities was less than $0.1 million for the nine months ended September 30, 2025, which primarily consisted of proceeds from sales of property and equipment.

Previous wording

Cash used in investing activities was $0.2 million for the six months ended June 30, 2024, which primarily consisted of leasehold improvements, purchases of the computer and lab equipment.

Current wording

Cash used in investing activities was $0.5 million for the nine months ended September 30, 2024, which primarily consisted of leasehold improvements, purchases of the computer and lab equipment.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2025 was $6.2 million, which consisted of net proceeds from the issuance and sale of shares of common stock under the ATM Offering of $5.9 million and proceeds from issuance of common stock pursuant to our employee stock purchase plan of $0.2 million.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2025 was $34.6 million, which consisted of net proceeds of $27.9 million from the issuance of common stock and warrants through the underwritten offering under the Shelf Registration Statement, net proceeds of $6.5 million from the issuance and sale of shares of common stock under the ATM Offering and proceeds from issuance of common stock pursuant to our employee stock purchase plan of $0.2 million.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2024 was $47.5 million, which consisted primarily of net proceeds from the issuance and sale of shares of common stock in an underwritten public offering of $47.2 million and cash received from the exercise of stock options of $0.3 million.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2024 was $47.5 million, which consisted primarily of net proceeds from the issuance and sale of shares of common stock in an underwritten public offering of $47.2 million, cash received from the exercise of stock options of $0.3 million and cash received from the issuance of common stock in connection with purchases under our employee stock purchase plan of less than $0.1 million.

Previous wording

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.

Current wording

Our critical accounting policies are disclosed in Note 2 to the condensed consolidated financial statements included in Part I - Item 1 of this Quarterly Report and Note 2 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. There have been no material changes to our significant accounting policies since the date of issuance of our consolidated financial statements for the year ended December 31, 2024, except for the accounting for warrants issued in connection with the underwritten offering in September 2025.
Rearranged current paragraphs (5)

Current report — wording carried from elsewhere

Total other income, net decreased by $0.9 million, from $1.3 million for the three months ended September 30, 2024 to $0.4 million for the three months ended September 30, 2025.

Current report — wording carried from elsewhere

Changes in the earnout liability and foreign currency transactions gains and losses were insignificant.

Current report — wording carried from elsewhere

Program costs increased by $13.8 million, from $21.1 million for the nine months ended September 30, 2024 to $34.9 million for the nine months ended September 30, 2025. Clinical program expenses primarily consisted of expenses incurred under agreements with CROs, consultants, other professional services, in vivo study costs and lab supplies. Clinical program expenses increased primarily due to an increase in CRO expenses of $5.6 million from $8.6 million for the nine months ended September 30, 2024 to $14.2 million for the nine months ended September 30, 2025 and an increase in the preclinical in vivo study costs of $2.6 million from $0.1 million for the nine months ended September 30, 2024 to $2.7 million for the nine months ended September 30, 2025.

Current report — wording carried from elsewhere

Interest income decreased by $2.7 million, from $4.1 million for the nine months ended September 30, 2024 to $1.4 million for the nine months ended September 30, 2025, primarily due to lower cash balances invested in money market funds.

Current report — wording carried from elsewhere

Changes in the earnout liability and foreign currency transactions gains and losses were insignificant.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

Historically, we have also evaluated briquilimab as a one-time conditioning therapy for SCID patients undergoing a second stem cell transplant for which we conducted a Phase 1/2 clinical trial as well as via Investigator Sponsored Trials (“ISTs”) in several other stem cell transplant indications. As of July 2025, the SCID program and any remaining ISTs were discontinued to focus resources exclusively on our mast cell disease development programs in CSU and CIndU.