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MBX Biosciences, Inc.

For the period ended Sep 30, 2025. Filed Nov 6, 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 6, 2025

MBX$51.35+6.0%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 2025-08-07.

0000950170-25-104619

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

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-06.

0001193125-25-268148

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 148 previous paragraphs and 148 current paragraphs.

122 unchanged; 24 reworded; 2 added; 1 removed; 1 previous and 0 current paragraphs rearranged.

Tables are not compared: 5 previous and 5 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 (2)

Current report

Comparison of the nine months ended September 30, 2025 and 2024

Current report

Net provided by financing activities for the nine months ended September 30, 2024 was $234.2 million, which primarily consisted of proceeds from our IPO, net of underwriting discounts and commissions, of $174.5 million in September 2024, gross proceeds from our issuance of Series C Convertible Preferred Stock of $63.5 million in August 2024 and $0.2 million in proceeds from the exercise of common stock options, partially offset by payments of offering costs related to our IPO of $3.7 million and preferred stock offering costs of $0.3 million.
Removed paragraphs (1)
Reworded paragraphs (24)

Previous wording

Our lead product candidate, canvuparatide (MBX 2109), is a parathyroid hormone peptide prodrug that is designed as a potential long-acting hormone replacement therapy for the treatment of chronic hypoparathyroidism, ("HP"). Leveraging our proprietary PEP platform, we designed canvuparatide to treat the underlying pathophysiology of HP by providing a continuous, infusion-like exposure to parathyroid hormone, ("PTH"), with convenient once-weekly administration. In a Phase 1 clinical trial, canvuparatide demonstrated a low ratio between the highest concentration of active drug observed after a dose and the concentration of active drug observed immediately prior to the next dose, ("peak-to-trough ratio"), which is consistent with a continuous, infusion-like profile, and an extended half-life, potentially enabling the first once-weekly PTH dosing regimen for patients with HP. Canvuparatide was generally well-tolerated with no drug-related severe or serious adverse effects. We are currently evaluating canvuparatide in a Phase 2 clinical trial in 64 patients with HP. In March 2025, we announced completion of enrollment, and we anticipate reporting topline data in the third quarter of 2025.

Current wording

Our lead product candidate, canvuparatide (MBX 2109), is a parathyroid hormone ("PTH") peptide prodrug that is designed as a potential long-acting hormone replacement therapy for the treatment of chronic hypoparathyroidism, ("HP"). Leveraging our proprietary PEP platform, we designed canvuparatide to treat the underlying pathophysiology of HP by providing a continuous, infusion-like exposure to PTH, with convenient once-weekly administration. In a Phase 1 clinical trial, canvuparatide demonstrated a low ratio between the highest concentration of active drug observed after a dose and the concentration of active drug observed immediately prior to the next dose, ("peak-to-trough ratio"), which is consistent with a continuous, infusion-like profile, and an extended half-life, potentially enabling the first once-weekly PTH dosing regimen for patients with HP. Canvuparatide was generally well-tolerated with no drug-related severe or serious adverse effects. In a Phase 2 clinical trial of 64 patients with HP, canvuparatide achieved the primary endpoint with a statistically significant responder rate at Week 12 and further demonstrated positive six-month responder results from the open-label extension portion of the trial. All patients completed the 12-week trial, and canvuparatide was generally well-tolerated, with no treatment-related serious adverse events or discontinuations. We expect to conduct both an End of Phase 2 meeting with the U.S. Food and Drug Administration ("FDA") and Scientific Advice with the European Medicines Agency, in the first quarter of 2026. We also intend to present results from our Phase 2 clinical trial at a medical meeting in the second quarter of 2026; report one-year results from our ongoing open-label extension study in the second quarter of 2026; and initiate a Phase 3 clinical trial of canvuparatide in the third quarter of 2026.

Previous wording

Our third program is our lead obesity product candidate, MBX 4291, which is designed to be a long-acting and highly potent GLP-1 and glucose-dependent insulinotropic polypeptide, or GIP, receptor co-agonist prodrug with the goal of potential once monthly dosing frequency and improving efficacy and tolerability relative to existing standards of care. On June 16, 2025, we announced the investigational new drug ("IND") application submission to the FDA for MBX 4291 and, in July 2025, we received clearance to proceed with a Phase 1 clinical trial, which is expected to begin in the third quarter of 2025. Beyond MBX 4291, we have a robust discovery pipeline including multiple programs in the lead optimization stage of development.

Current wording

Our lead obesity product candidate, MBX 4291, is designed to be a long-acting and highly potent PEP™ GLP-1 and glucose-dependent insulinotropic polypeptide ("GIP"), receptor co-agonist prodrug with the goal of potential once monthly dosing frequency and improved efficacy and tolerability relative to existing standards of care. In our preclinical studies, the active component of MBX 4291 demonstrated a similar activity profile and body weight loss in mice as tirzepatide, an approved weekly GLP-1/GIP co-agonist, and an extended duration of action of the active component of MBX 4291, supporting the potential for once-monthly administration. During our preclinical studies, the concentration of the active component of MBX 4291 was significantly lower than the concentration of tirzepatide during the comparison period. Although we believe MBX 4291 has the potential to be dosed less frequently, less frequent dosing would require a higher dose of MBX 4291. The results observed from our preclinical studies may not necessarily be predictive of the results of later-stage clinical trials that we may conduct. In addition, the study supporting potential duration of MBX 4291 was conducted separately from studies evaluating its effects. We are conducting a randomized, double-blind, placebo controlled Phase 1 clinical trial designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of SAD and MAD doses in adults with obesity. Following the SAD and four-week MAD portions of the trial, we plan to evaluate multiple ascending doses of MBX 4291, or matching placebo, administered over 12 weeks in up to two cohorts consisting of thirty participants. Results from the planned 12-week MAD portion are expected in the fourth quarter of 2026. Beyond MBX 4291, we have a robust discovery pipeline including multiple programs in the lead optimization stage of development.

Previous wording

Our second program is imapextide (MBX 1416), which is designed to be a long-acting glucagon-like peptide-1 ("GLP-1") receptor antagonist, as a potential therapy for post-bariatric hypoglycemia, ("PBH"), a chronic complication of bariatric surgery. Imapextide is designed as a convenient once-weekly therapy to reduce insulin secretion and increase blood glucose to reduce the frequency and severity of hypoglycemic events. The single ascending dose ("SAD") portion of this Phase 1 trial evaluated subcutaneous imapextide doses of 10 milligrams (“mg”), 30 mg, 100 mg and 200 mg, in up to eight healthy adults per cohort randomized 3:1 (six imapextide; two placebo in each cohort). The multiple ascending dose ("MAD") portion of the trial evaluated four weekly subcutaneous doses of placebo and 10 mg, 30 mg (as two injections) and 30 mg (as one injection) imapextide in three cohorts in up to eight healthy adults per cohort (six imapextide; two placebo in each cohort). An additional cohort assessed the clinical relevance of preclinical transporter findings. In January 2025, we announced positive topline results from our Phase 1 SAD and MAD clinical trial of imapextide in healthy adult volunteers. Results from the Phase 1 clinical trial demonstrated dose-proportional increases in imapextide exposure, a median half-life of 90 hours, which is supportive of a once-weekly dosing regimen, and, at steady state, the median Tmax was between 36 and 48 hours. Imapextide was generally well-tolerated with a favorable safety profile and no treatment-related serious adverse events. We completed an End-of-Phase 1 meeting with U.S. Food and Drug Administration ("FDA"), and a Phase 2a clinical trial evaluating imapextide in patients with PBH is anticipated to initiate in the third quarter of 2025.

Current wording

Our program, imapextide (MBX 1416), is designed to be a long-acting glucagon-like peptide-1 ("GLP-1") receptor antagonist, as a potential therapy for post-bariatric hypoglycemia, ("PBH"), a chronic complication of bariatric surgery. Imapextide is designed as a convenient once-weekly therapy to reduce insulin secretion and increase blood glucose to reduce the frequency and severity of hypoglycemic events. The single ascending dose ("SAD") portion of this Phase 1 trial evaluated subcutaneous imapextide doses of 10 milligrams (“mg”), 30 mg, 100 mg and 200 mg, in up to eight healthy adults per cohort randomized 3:1 (six imapextide; two placebo in each cohort). The multiple ascending dose ("MAD") portion of the trial evaluated four weekly subcutaneous doses of placebo and 10 mg, 30 mg (as two injections) and 30 mg (as one injection) imapextide in three cohorts in up to eight healthy adults per cohort (six imapextide; two placebo in each cohort). An additional cohort assessed the clinical relevance of preclinical transporter findings. In January 2025, we announced positive topline results from our Phase 1 SAD and MAD clinical trial of imapextide in healthy adult volunteers. Results from the Phase 1 clinical trial demonstrated dose-proportional increases in imapextide exposure, a median half-life of 90 hours, which is supportive of a once-weekly dosing regimen, and, at steady state, the median Tmax was between 36 and 48 hours. Imapextide was generally well-tolerated with a favorable safety profile and no treatment-related serious adverse events. We are conducting a Phase 2a, open-label clinical trial evaluating primary efficacy of subcutaneous imapextide in adult patients with PBH. Approximately ten patients with a history of hypoglycemia following Roux-en-Y or sleeve gastrectomy will undergo three mixed-meal tolerance tests after each imapextide administration, to evaluate the pharmacodynamic effect of imapextide. Topline results are expected in the second quarter of 2026.

Previous wording

Since our inception, we have devoted substantially all of our resources to drug discovery and development of our product candidates, canvuparatide, imapextide and MBX 4291, and other preclinical programs, building our intellectual property portfolio, organizing and staffing our company, business planning, raising capital and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any revenue from product sales. In September 2024, we completed our initial public offering (the "IPO"), pursuant to which we issued and sold 11,730,000 shares of common stock (inclusive of 1,530,000 shares of commons stock sold pursuant to the underwriters' exercise of their option to purchase additional shares). The aggregate net proceeds received by use from the IPO were $170.5 million, after deducting underwriting discounts and commissions and other offering costs of $17.2 million. We have historically funded our operations primarily from the issuance and sale of our common stock, convertible preferred stock and convertible notes, which generated approximately $401.8 million in aggregate gross proceeds.

Current wording

Since our inception, we have devoted substantially all of our resources to drug discovery and development of our product candidates, canvuparatide, imapextide and MBX 4291, and other preclinical programs, building our intellectual property portfolio, organizing and staffing our company, business planning, raising capital and providing general and administrative support for these operations. We do not have any products approved for sale and have not generated any revenue from product sales. In September 2024, we completed our initial public offering (the "IPO"), pursuant to which we issued and sold 11,730,000 shares of common stock (inclusive of 1,530,000 shares of commons stock sold pursuant to the underwriters' exercise of their option to purchase additional shares). The aggregate net proceeds received by use from the IPO were $170.5 million, after deducting underwriting discounts and commissions and other offering costs of $17.2 million. In September 2025, we completed an underwritten public offering (the "September 2025 Offering") of 11,108,055 shares of our common stock, which generated approximately $187.4 million in aggregate net proceeds, after deducting underwriting discounts and commissions and other offering costs of $12.5 million. We have historically funded our operations primarily from the issuance and sale of our common stock, convertible preferred stock and convertible notes, which have generated approximately $601.7 million in cumulative, aggregate gross proceeds.

Previous wording

We have incurred significant operating losses since inception and we expect to continue to incur substantial losses for the foreseeable future. Our ability to generate revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Our net losses were $19.4 million and $15.9 million for the three months ended June 30, 2025 and 2024, respectively. Our net losses were $43.3 million and $28.2 million for the six months ended June 30, 2025 and 2024, respectively. We had an accumulated deficit of $180.8 million and $137.5 million as of June 30, 2025 and December 31, 2024, respectively.

Current wording

We have incurred significant operating losses since inception and we expect to continue to incur substantial losses for the foreseeable future. Our ability to generate revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Our net losses were $21.6 million and $18.1 million for the three months ended September 30, 2025 and 2024, respectively. Our net losses were $64.9 million and $46.3 million for the nine months ended September 30, 2025 and 2024, respectively. We had an accumulated deficit of $202.4 million and $137.5 million as of September 30, 2025 and December 31, 2024, respectively.

Previous wording

We had cash, cash equivalents and marketable securities of $224.9 million and $262.1 million as of June 30, 2025 and December 31, 2024, respectively. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into mid-2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Liquidity and capital resources” herein and “Risk Factors—Risks related to financial position and need for capital” from Item 1A Risk Factors in our Annual Report.

Current wording

We had cash, cash equivalents and marketable securities of $391.7 million and $262.1 million as of September 30, 2025 and December 31, 2024, respectively. We believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “Liquidity and capital resources” herein and “Risk Factors—Risks related to financial position and need for capital” from Item 1A Risk Factors in our Annual Report.

Previous wording

Research and development expenses were $17.7 million for the three months ended June 30, 2025, as compared to $14.4 million for the three months ended June 30, 2024. The increase of $3.3 million consisted of the following:

Current wording

Research and development expenses were $19.3 million for the three months ended September 30, 2025, as compared to $16.7 million for the three months ended September 30, 2024. The increase of $2.5 million consisted of the following:

Previous wording

Direct research and development program expenses related to canvuparatide increased by $3.9 million, primarily due to increased activities related to the Phase 2 clinical trial. Direct program expenses related to imapextide decreased by $4.1 million, primarily due to the completion of the Phase 1 clinical trial in the first quarter of 2025. Direct program expenses for MBX 4291 increased by $1.0 million primarily due to preclinical studies and manufacturing activities related to MBX 4291, for which the IND was filed in June 2025. Direct program expenses for preclinical and other programs increased by $1.3 million primarily due to pipeline candidate development activities. Personnel-related costs (including stock-based compensation), increased by $1.1 million, primarily due to increased headcount and stock-based compensation expense. Facility-related and other expenses, which include allocated overhead, including rent, repairs and maintenance costs, common facilities and information technology-related expenses allocated to research and development increased by $0.1 million.

Current wording

Direct research and development program expenses related to canvuparatide increased by $4.2 million, primarily due to increased activities related to conduct of the Phase 2 clinical trial and increased manufacturing in preparation for the Phase 3 clinical trial. Direct program expenses for MBX 4291 decreased by $2.8 million primarily due to the timing of preclinical studies and manufacturing activities, partially offset by a $1.0 million IURTC milestone that was triggered in the three months ended September 30, 2025 related to the initiation of the Phase 1 clinical trial of MBX 4291. Direct program expenses related to imapextide decreased by $1.4 million, primarily due to the completion of the Phase 1 clinical trial in the first quarter of 2025. Direct program expenses for preclinical and other programs increased by $1.3 million primarily due to pipeline candidate development activities. Personnel-related costs (including stock-based compensation), increased by $1.2 million, primarily due to increased headcount and stock-based compensation expense. Facility-related and other expenses, which include allocated overhead, including rent, repairs and maintenance costs, common facilities and information technology-related expenses allocated to research and development increased by $0.2 million.

Previous wording

General and administrative expenses were $4.1 million for the three months ended June 30, 2025, as compared to $2.3 million for the three months ended June 30, 2024. The increase of $1.8 million was primarily due to higher professional fees related to legal and accounting services and higher personnel-related costs, including compensation, benefits and stock-based compensation, as we expanded our infrastructure to support growth in our operations as a public company.

Current wording

General and administrative expenses were $4.7 million for the three months ended September 30, 2025, as compared to $2.9 million for the three months ended September 30, 2024. The increase of $1.8 million was primarily due to higher professional fees related to legal and accounting services and higher personnel-related costs, including compensation, benefits and stock-based compensation, as we expanded our infrastructure to support growth in our operations as a public company.

Previous wording

Interest and other income, net, which includes interest income and amortization of premiums and discounts on our investments in marketable securities, were $2.4 million for the three months ended June 30, 2025, as compared to $0.8 million for the three months ended June 30, 2024. The increase of $1.6 million was due to increased interest on our cash, cash equivalents and marketable securities, which increased primarily due to our IPO in September 2024 and the Series C Convertible Preferred Stock financing in August 2024.

Current wording

Interest and other income, net, which includes interest income and amortization of premiums and discounts on our investments in marketable securities, were $2.3 million for the three months ended September 30, 2025, as compared to $1.5 million for the three months ended September 30, 2024. The increase of $0.8 million was due to increased interest on our cash, cash equivalents and marketable securities, which increased primarily due to our IPO in September 2024, the Series C Convertible Preferred Stock financing in August 2024 and the September 2025 Offering.

Previous wording

Research and development expenses were $40.1 million for the six months ended June 30, 2025, as compared to $25.4 million for the six months ended June 30, 2024. The increase of $14.7 million consisted of the following:

Current wording

Research and development expenses were $59.4 million for the nine months ended September 30, 2025, as compared to $42.2 million for the nine months ended September 30, 2024. The increase of $17.2 million consisted of the following:

Previous wording

Direct research and development program expenses related to canvuparatide increased by $8.3 million, primarily due to increased activities related to conduct of the Phase 2 clinical trial, clinical supply manufacturing costs and costs associated with conducting preclinical studies. Direct program expenses related to imapextide decreased by $5.0 million, primarily due to the completion of the Phase 1 clinical trial in the first quarter of 2025. Direct program expenses for MBX 4291 increased by $6.2 million, primarily due to preclinical studies and manufacturing activities related to MBX 4291, for which the IND was filed in June 2025. Direct program expenses for preclinical and other programs increased by $2.3 million, primarily due to pipeline candidate development activities. Personnel-related costs (including stock-based compensation), increased by $2.6 million, primarily due to increased headcount and stock-based compensation expense. Facility-related and other expenses, which include allocated overhead, including rent, repairs and maintenance costs, common facilities and information technology-related expenses allocated to research and development increased by $0.3 million.

Current wording

Direct research and development program expenses related to canvuparatide increased by $12.5 million, primarily due to increased activities related to conduct of the Phase 2 clinical trial, costs associated with conducting preclinical studies and an increase in manufacturing costs in preparation for the Phase 3 trial. Direct program expenses for MBX 4291 increased by $3.3 million, primarily due to preclinical studies and manufacturing activities, for which the IND was filed in June 2025, and a $1.0 million IURTC milestone that was triggered in the nine months ended September 30, 2025 related to the initiation of the Phase 1 clinical trial of MBX 4291. Direct program expenses related to imapextide decreased by $6.4 million, primarily due to the completion of the Phase 1 clinical trial in the first quarter of 2025. Direct program expenses for preclinical and other programs increased by $3.5 million, primarily due to pipeline candidate development activities. Personnel-related costs (including stock-based compensation), increased by $3.8 million, primarily due to increased headcount and stock-based compensation expense. Facility-related and other expenses, which include allocated overhead, including rent, repairs and maintenance costs, common facilities and information technology-related expenses allocated to research and development increased by $0.4 million.

Previous wording

General and administrative expenses were $8.2 million for the six months ended June 30, 2025, as compared to $4.5 million for the six months ended June 30, 2024. The increase of $3.7 million was primarily due to higher professional fees related to legal, insurance and accounting services and higher personnel-related costs, including compensation, benefits and stock-based compensation, as we expanded our infrastructure to support growth in our operations as a public company.

Current wording

General and administrative expenses were $12.9 million for the nine months ended September 30, 2025, as compared to $7.4 million for the nine months ended September 30, 2024. The increase of $5.5 million was primarily due to higher professional fees related to legal, insurance and accounting services and higher personnel-related costs, including compensation, benefits and stock-based compensation, as we expanded our infrastructure to support growth in our operations as a public company.

Previous wording

Interest and other income, net, which includes interest income and amortization of premiums and discounts on our investments in marketable securities, were $5.0 million for the six months ended June 30, 2025, as compared to $1.8 million for the six months ended June 30, 2024. The increase of $3.2 million was due to increased interest on our cash, cash equivalents and marketable securities, which increased primarily due to our IPO in September 2024 and the Series C Convertible Preferred Stock financing in August 2024.

Current wording

Interest and other income, net, which includes interest income and amortization of premiums and discounts on our investments in marketable securities, were $7.4 million for the nine months ended September 30, 2025, as compared to $3.2 million for the nine months ended September 30, 2024. The increase of $4.1 million was due to increased interest on our cash, cash equivalents and marketable securities, which increased primarily due to our IPO in September 2024, the Series C Convertible Preferred Stock financing in August 2024 and the September 2025 Offering.

Previous wording

Since our inception, we have incurred significant operating losses. We have historically funded our operations primarily through our IPO and sales of our convertible preferred stock and convertible notes, which have generated approximately $401.8 million in aggregate gross proceeds. As of June 30, 2025 and December 31, 2024, we had $224.9 million and $262.1 million in cash, cash equivalents and marketable securities, respectively. We have not yet generated any revenue from product sales and do not expect to in the foreseeable future as our product candidates are in various phases of clinical and preclinical development.

Current wording

Since our inception, we have incurred significant operating losses. We have historically funded our operations primarily through our IPO, the September 2025 Offering, and sales of our convertible preferred stock and convertible notes, which have generated approximately $601.7 million in cumulative, aggregate gross proceeds. As of September 30, 2025 and December 31, 2024, we had $391.7 million and $262.1 million in cash, cash equivalents and marketable securities, respectively. We have not yet generated any revenue from product sales and do not expect to in the foreseeable future as our product candidates are in various phases of clinical and preclinical development.

Previous wording

We had $224.9 million and $262.1 million in cash, cash equivalents and marketable securities as of June 30, 2025 and December 31, 2024, respectively. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our current operating plan for at least the next 12 months from the date of issuance of the accompanying unaudited condensed financial statements. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities will be sufficient to fund our projected operating expenses and capital expenditure requirements into mid-2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

Current wording

We had $391.7 million and $262.1 million in cash, cash equivalents and marketable securities as of September 30, 2025 and December 31, 2024, respectively. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our current operating plan for at least the next 12 months from the date of issuance of the accompanying unaudited condensed financial statements. Based on our current operating plan, we estimate that our existing cash, cash equivalents and marketable securities will be sufficient to fund our projected operating expenses and capital expenditure requirements into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2025 was $40.1 million. This was primarily due to our net loss of $43.3 million, partially offset by net cash provided by changes in our operating assets and liabilities of $1.6 million and non-cash charges of $1.7 million. The changes in our net operating assets and liabilities primarily consisted of a $0.9 million increase in our prepaid expenses and other current assets related to prepaid balances with CROs, a $0.8 million increase in accounts payable and accrued expenses primarily related to balances with CROs. Non-cash charges primarily consisted of $3.8 million of stock-based compensation expense, $0.1 million of depreciation expense related to our property and equipment and $0.1 million of amortization expense related to our right-of-use asset, partially offset by $2.3 million of net amortization and accretion of marketable securities.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025 was $61.6 million. This was primarily due to our net loss of $64.9 million, partially offset by non-cash charges of $3.3 million. Non-cash charges primarily consisted of $6.0 million of stock-based compensation expense, $0.2 million of depreciation expense related to our property and equipment and $0.1 million of amortization expense related to our right-of-use asset, partially offset by $3.1 million of net amortization and accretion of marketable securities. The changes in our net operating assets and liabilities primarily consisted of a $0.7 million increase in our prepaid expenses and other current assets related to prepaid balances with CROs and CDMOs offset by a $0.7 million increase in accounts payable and accrued expenses primarily related to balances with CROs and CDMOs.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2024 was $24.0 million. This was primarily due to our net loss of $28.2 million, partially offset by net cash provided by changes in our operating assets and liabilities of $2.5 million and non-cash charges of $1.8 million. The changes in our net operating assets and liabilities primarily consisted of a $3.3 million increase in accounts payable and accrued expenses primarily related to balances with CDMOs, partially offset by a $0.8 million decrease in our prepaid expenses and other current assets. Non-cash charges primarily consisted of $2.5 million of stock-based compensation expense, $0.1 million of depreciation expense related to our property and equipment and $0.1 million of amortization expense related to our right-of-use asset, partially offset by $0.9 million of net amortization and accretion of marketable securities.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2024 was $38.6 million. This was primarily due to our net loss of $46.3 million, partially offset by net cash provided by changes in our operating assets and liabilities of $5.2 million and non-cash charges of $2.5 million. The changes in our net operating assets and liabilities primarily consisted of a $6.7 million increase in accounts payable and accrued expenses primarily related to balances with CDMOs, partially offset by a $1.3 million increase in our prepaid expenses and other current assets related to prepaid balances with CROs. Non-cash charges primarily consisted of $3.7 million of stock-based compensation expense, partially offset by $1.5 million of net amortization and accretion of marketable securities.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2025 was $29.2 million, which consisted of maturities of marketable securities of $130.3 million and redemptions of marketable securities of $6.0 million, partially offset by purchases of marketable securities of $106.3 million and purchases of property and equipment of $0.8 million.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2025 was $46.3 million, which consisted of maturities of marketable securities of $191.6 million and redemptions of marketable securities of $8.5 million, partially offset by purchases of marketable securities of $152.7 million and purchases of property and equipment of $1.1 million.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2024 was $7.5 million, which consisted of maturities of marketable securities of $32.5 million, partially offset by purchases of marketable securities of $24.2 million and purchases of property and equipment of $0.7 million.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2024 was $93.3 million, which consisted of purchases of marketable securities of $152.0 million and purchases of property and equipment of $0.8 million, partially offset by maturities of marketable securities of $59.5 million.

Previous wording

Net cash used in financing activities for the six months ended June 30, 2024 was $1.6 million, which consisted of payments of offering costs related to our IPO of $1.8 million, partially offset by $0.2 million in proceeds from the exercise of common stock options.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2025 was $189.2 million, which consisted of proceeds of $187.9 million from the September 2025 Offering, net of underwriting discounts and commissions and $1.5 million of proceeds from the exercise of common stock options, partially offset by payments totaling $0.3 million related to offering costs for the September 2025 Offering.

Previous wording

We have entered into two separate lease agreements for corporate office space and laboratory space, with terms extending through December 2028 and December 2025, respectively. The lease for our corporate office space was amended in May 2025 as further discussed in Note 9 to our interim unaudited condensed financial statements included elsewhere in this Quarterly Report. As of June 30, 2025, our future remaining operating lease payments were $0.8 million, with $0.2 million payable within the next twelve months, with respect to leases already commenced as of such date. As of December 31, 2024, our future remaining operating lease payments were $0.2 million, with $0.2 million payable within the next twelve months, with respect to leases already commenced as of such date.

Current wording

We have entered into two separate lease agreements for corporate office space and laboratory space, with terms extending through December 2028 and December 2025, respectively. The lease for our corporate office space was amended in May 2025 as further discussed in Note 9 to our interim unaudited condensed financial statements included elsewhere in this Quarterly Report. As of September 30, 2025, our future remaining operating lease payments were $0.7 million, with $0.2 million payable within the next twelve months, with respect to leases already commenced as of such date. As of December 31, 2024, our future remaining operating lease payments were $0.2 million, with $0.2 million payable within the next twelve months, with respect to leases already commenced as of such date.

Previous wording

Under the IURTC License Agreement, we have payment obligations that are contingent upon future events, such as the achievement of specified development, regulatory and commercial milestones, and in some cases, we are required to make royalty payments in connection with the sales of products developed under those agreements. Although we could be required to make milestone payments under the IURTC License Agreement, we are unable to estimate the timing or likelihood of achieving the milestones or making future product sales. For additional details regarding the IURTC License Agreement, see the section herein titled “License agreement” included in our 2024 Annual Report.

Current wording

Under the IURTC License Agreement, we have payment obligations that are contingent upon future events, such as the achievement of specified development, regulatory and commercial milestones, and in some cases, we are required to make royalty payments in connection with the sales of products developed under those agreements. Although we could be required to make additional future milestone payments under the IURTC License Agreement, we are unable to estimate the timing or likelihood of achieving the milestones or making future product sales. For additional details regarding the IURTC License Agreement and related obligations, refer to Note 9 in our interim unaudited condensed financial statements included elsewhere in this Quarterly Report, and see the section herein titled “License agreement” included in our 2024 Annual Report.

Previous wording

During the six months ended June 30, 2025, there were no material changes to our critical accounting policies and estimates described under Management’s Discussion and Analysis of Critical Accounting Policies and Estimates which are included in our 2024 Annual Report.

Current wording

During the nine months ended September 30, 2025, there were no material changes to our critical accounting policies and estimates described under Management’s Discussion and Analysis of Critical Accounting Policies and Estimates which are included in our 2024 Annual Report.
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Previous report — wording carried elsewhere

Net cash provided by financing activities for the six months ended June 30, 2025 was $1.3 million, which consisted of proceeds from the exercise of common stock options.