Septerna, Inc.
For the period ended Sep 30, 2025. Filed Nov 10, 2025.
View on SEC.govAbout 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
SEPN$48.85+3.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-11.
0000950170-25-106551
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-10.
0001193125-25-273375
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 146 previous paragraphs and 173 current paragraphs.
110 unchanged; 34 reworded; 27 added; 1 removed; 1 previous and 2 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 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 (27)
Current report
Recent Developments
Current report
SEP-479 PTH1R Agonist Program:
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o
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In September 2025, we provided an update on SEP-479, our oral small molecule parathyroid hormone 1 receptor (“PTH1R”) agonist program for hypoparathyroidism. In February 2025, we discontinued the Phase 1 clinical trial for SEP-786 as a result of observations of hyperbilirubinemia. The findings from our post-discontinuation investigation found that SEP-786 is a potent UGT1A1 inhibitor, which is a mechanism known to be associated with increases in unconjugated bilirubin. In a follow-up cynomolgus monkey study of SEP-786, conducted after clinical discontinuation, we also observed elevated unconjugated bilirubin levels.
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We announced in September 2025 that we had selected a new PTH1R development candidate, SEP-479. We presented preclinical data for SEP-479 from a translational rat thyroparathyroidectomy model demonstrating that SEP-479 achieved sustained normalization of serum calcium and phosphate levels over a 28-day dosing period. We also conducted a seven-day pharmacokinetic (“PK”) / pharmacodynamic (“PD”) study of SEP-479 in healthy cynomolgus monkeys, which showed robust, dose-dependent increases in serum calcium and decreases in endogenous parathyroid hormone levels across multiple dose levels of SEP-479.
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We observed no significant inhibition of UGT1A1 or other transporters for SEP-479 and no hyperbilirubinemia in any of the non-clinical studies to date for SEP-479, including the 7-day cynomolgus monkey study at supratherapeutic doses. SEP-479 was generally well-tolerated in the completed 28-day GLP toxicology studies in rats and dogs. Prior to the planned Phase 1 clinical trial initiation for SEP-479, we are also completing a 28-day GLP toxicology study in cynomolgus monkeys as an additional safety species. We plan to initiate a Phase 1 clinical trial for SEP-479 in the first half of 2026, pending the successful completion of all remaining preclinical studies, drug product manufacturing, and regulatory submissions.
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SEP-631 MRGPRX2 NAM Program:
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o
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In August 2025, we announced the dosing of the first participants in our Phase 1 clinical trial of SEP-631, a selective oral small molecule Mas-related G protein-coupled receptor X2 (“MRGPRX2”) negative allosteric modulator being developed for the treatment of chronic spontaneous urticaria and other mast cell-driven diseases. The Phase 1 single-ascending dose (“SAD”) and multiple-ascending dose (“MAD”) clinical trial will evaluate the safety, tolerability, PK and PD of SEP-631 in healthy adult volunteers. The randomized, placebo-controlled Phase 1 SAD / MAD clinical trial is expected to enroll up to approximately 150 healthy adult volunteers. The SAD portion of the trial will evaluate the safety and tolerability of SEP-631 at escalating oral doses. The MAD portion of the trial will evaluate the safety and tolerability of oral doses of SEP-631 over the treatment period, and PD will be assessed through an icatibant skin challenge. We anticipate initial SAD/MAD data to be announced in the first half of 2026.
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TSHR NAM Program:
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o
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We continue to make progress on our TSHR NAM program, advancing several lead compounds closer to development candidate selection with the goal of delivering a potential disease-modifying oral treatment for Graves’ disease and thyroid eye disease.
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Discovery Programs:
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We continue to advance discovery-stage programs utilizing our Native Complex Platform™ across multiple therapeutic areas.
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our ability to replicate positive results from a completed clinical study in a future clinical study;
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delays or disruptions in review, approval, inspection, or other actions by the FDA or other applicable U.S. or foreign government regulatory authorities that could impact the timing, initiation, conduct, or completion of our clinical trials or marketing applications;
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our ability to maintain existing collaborations and strategic relationships, to identify and establish any future collaboration arrangements on favorable terms, if at all, and to realize the intended and potential benefits of such agreements and collaborations;
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IT-related expenses, (v) $0.4 million of higher facility-related and office costs as a result of increased operational activities and operating as a public company and (vi) $0.6 million of other general and administrative expenses.
Current report
Gain on sale of non-financial asset of $12.5 million during the three and nine months ended September 30, 2025 was attributable to a milestone payment under the Vertex Asset Purchase Agreement during the year ended December 31, 2023. No gain on sale of non-financial asset was recorded during the three and nine months ended September 30, 2024.
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Net Cash Provided by (Used in) Operating Activities
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our ability to successfully develop, obtain regulatory and marketing approvals of our product candidates for the expected indications and patient populations;
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regulatory or legal developments in the United States and other countries;
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Revenue Recognition
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We account for revenue in accordance with ASC 606, “Revenue from Contracts with Customers” (“ASC 606”). Under ASC 606, we recognize revenue when the customer obtains control of the promised goods or services at an amount that reflects the consideration we expect to receive in exchange for those goods or services. See Note 1, Significant Accounting Policies, to our condensed financial statements included elsewhere in this Quarterly Report for additional information.
Removed paragraphs (1)
Previous report
our ability to maintain and establish collaboration arrangements;
Reworded paragraphs (34)
Previous wording
We are a biotechnology company pioneering a new era of G protein-coupled receptor (“GPCR”) oral small molecule drug discovery powered by our proprietary Native Complex Platform™. Our industrial-scale platform aims to unlock the full potential of GPCR therapies and has led to the discovery and development of our deep pipeline of product candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases.
Current wording
We are a clinical-stage biotechnology company with a world-class team of G protein-coupled receptor (“GPCR”) experts and drug developers advancing cutting-edge science to unlock the full potential of GPCR therapies for patients with significant unmet needs. Our proprietary Native Complex Platform™ is designed to enable new approaches to GPCR drug discovery and has led to the development of a diverse pipeline of novel oral small molecule drug candidates.
Previous wording
We are advancing a deep portfolio of oral small molecule GPCR-targeted programs with novel mechanistic approaches to treat diseases across multiple therapeutic areas for patients with significant unmet needs. Our wholly-owned pipeline, summarized in the figure below, is focused initially on three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases.
Current wording
We are advancing a deep portfolio of oral small molecule GPCR-targeted programs with novel mechanistic approaches to treat diseases across multiple therapeutic areas for patients with significant unmet needs. Our wholly-owned pipeline is summarized in the figure below.
Previous wording
We have incurred significant operating losses since our inception, except for the year ended December 31, 2023, when we recorded net income of $4.2 million, resulting from the gain on sale of non-financial asset of $47.6 million for the sale of an in-progress research and development (“IPR&D”) asset related to a GPCR program. Our revenue to date has been generated solely from research services. Since our founding, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, developing our proprietary and structure-based drug discovery platform, identifying and discovering our product candidates, establishing our intellectual property portfolio, conducting research and preclinical studies, including investigational new drug (“IND”)-enabling studies, initiating and conducting clinical trials, establishing arrangements with third parties for the manufacture of our product candidates and related raw materials, and providing general and administrative support for these operations. We have not had any products approved for sale and have not generated any revenue from product sales. Further, we do not expect to generate revenue from commercial product sales until such time, if ever, that we are able to successfully complete the development and obtain marketing approval for one or more of our product candidates. Our ability to generate product revenue will depend on the successful development and eventual commercialization of one or more of our product candidates.
Current wording
We have incurred significant operating losses since our inception, except for the year ended December 31, 2023, when we recorded net income of $4.2 million, resulting from the gain on sale of non-financial asset of $47.6 million for the sale of an in-progress research and development (“IPR&D”) asset related to a GPCR program and the three months ended September 30, 2025 when we recorded net income of $8.2 million, resulting from the $21.5 million of revenue and $12.5 million of gain on sale of a non-financial asset. Our revenue to date has been generated solely from research services and the recognition of the one-time, non-refundable upfront payment of $195.0 million from our collaboration agreement. Since our founding, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, developing our proprietary and structure-based drug discovery platform, identifying and discovering our product candidates, establishing our intellectual property portfolio, conducting research and preclinical studies, including investigational new drug (“IND”)-enabling studies, initiating and conducting clinical trials, establishing arrangements with third parties for the manufacture of our product candidates and related raw materials, and providing general and administrative support for these operations. We have not had any products approved for sale and have not generated any revenue from product sales. Further, we do not expect to generate revenue from commercial product sales until such time, if ever, that we are able to successfully complete the development and obtain marketing approval for one or more of our product candidates. Our ability to generate product revenue will depend on the successful development and eventual commercialization of one or more of our product candidates.
Previous wording
Our net losses may fluctuate significantly from period to period, depending upon the timing of our expenditures on research and development activities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses and other current liabilities, which includes accrued research and development, in the statements of cash flows in our audited and unaudited interim condensed financial statements included elsewhere in the Quarterly Report. Our net loss was $46.3 million and $30.6 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $164.7 million.
Current wording
Our net losses may fluctuate significantly from period to period, depending upon the timing of our expenditures on research and development activities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses and other current liabilities, which includes accrued research and development, in the statements of cash flows in our audited and unaudited interim condensed financial statements included elsewhere in the Quarterly Report. Our net loss was $38.1 million and $51.1 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $156.5 million.
Previous wording
We conduct research and manufacturing work outside of the U. S., including China, that may be affected by tariffs, including tariffs that have been or may in the future be imposed by the U.S. or other countries through reciprocal tariffs. While we do not currently believe tariffs will have a material impact on our business or results of operations, we will continue to carefully monitor the situation.
Current wording
We conduct research and manufacturing work outside of the U.S., including China, that may be affected by tariffs, including tariffs that have been or may in the future be imposed by the U.S. or other countries through reciprocal tariffs. While we do not currently believe tariffs will have a material impact on our business or results of operations, we will continue to carefully monitor the situation. Additionally, we continue to actively monitor macroeconomic conditions and market volatility resulting from global and national economic developments, political unrest, high inflation, disruptions in capital markets, changes in international trade relationships, changes in or the disruptions of U.S. governmental agencies, whether from a continued U.S. federal government shutdown or reduced resources, new laws and regulations or amendments to existing laws and regulations in the U.S. and foreign countries, and military conflicts. While we believe such factors have had no significant impact on our business or financial results during the periods presented, future developments and potential impacts on our business are uncertain and cannot be predicted with confidence.
Previous wording
In July 2025, following the receipt of the antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), the Novo Collaboration Agreement became effective and, subsequently, we received a one-time, non-refundable upfront payment of $195.0 million. For each R&D Program, we are also eligible to receive up to approximately $498.0 million in research, development, regulatory, and commercial milestone payments. In addition, we are entitled to escalating, tiered royalties ranging from mid-to-high single-digits based on global product sales on a country-by-country and product-by-product basis with respect to a R&D Program until the later of ten years after the date of first commercial sale of the first product in such R&D Program in such country, expiration of specified patent rights covering such product in such country or the expiration of specified regulatory exclusivity for the first product in such R&D Program in such country. See Note 3 to the condensed financial statements included elsewhere in this Quarterly Report for additional information.
Current wording
In July 2025, the Novo Collaboration Agreement became effective and, subsequently, we received a one-time, non-refundable upfront payment of $195.0 million, which was recorded as deferred revenue in our condensed balance sheet. For each R&D Program, we are also eligible to receive up to approximately $498.0 million in research, development, regulatory, and commercial milestone payments. In addition, we are entitled to escalating, tiered royalties ranging from mid-to-high single-digits based on global product sales on a country-by-country and product-by-product basis with respect to a R&D Program until the later of ten years after the date of first commercial sale of the first product in such R&D Program in such country, expiration of specified patent rights covering such product in such country or the expiration of specified regulatory exclusivity for the first product in such R&D Program in such country. See Note 3 to the condensed financial statements included elsewhere in this Quarterly Report for additional information.
Previous wording
In September 2023, we entered into an asset purchase agreement with Vertex Pharmaceuticals Incorporated (“Vertex”) under which Vertex acquired an IPR&D asset related to a GPCR program, including all intellectual property, materials, and compounds associated with the program (“Vertex Asset Purchase Agreement”). The Vertex Asset Purchase Agreement also provides for a potential milestone payment payable to us contingent upon the achievement of a milestone event. As of June 30, 2025, the variable consideration related to this milestone payment was determined to be improbable of receipt.
Current wording
In September 2023, we entered into an asset purchase agreement with Vertex Pharmaceuticals Incorporated (“Vertex”) under which Vertex acquired an IPR&D asset related to a GPCR program, including all intellectual property, materials, and compounds associated with the program (“Vertex Asset Purchase Agreement”). The Vertex Asset Purchase Agreement also provided for a potential milestone payment payable to us contingent upon the achievement of a milestone event.
Previous wording
In July 2025, this milestone event was determined to have been achieved and, as a result, we received a payment of $12.5 million in August 2025. After this milestone payment, we will not receive any other payments related to this IPR&D asset.
Current wording
In July 2025, this milestone event was determined to have been achieved and, as a result, we received a payment of $12.5 million in August 2025, which was recorded as a gain on sale of the non-financial asset within our total operating income (expenses) in our condensed statement of operations and comprehensive loss for the three and nine months ended September 30, 2025. We will not receive any other payments related to this IPR&D asset.
Previous wording
In conjunction with the Vertex Asset Purchase Agreement, we entered into a research service agreement with Vertex under which we agreed to perform certain exploratory research activities for Vertex (“Vertex Research Service Agreement”).
Current wording
In conjunction with the Vertex Asset Purchase Agreement in September 2023, we entered into a research service agreement with Vertex under which we agreed to perform certain exploratory research activities for Vertex (“Vertex Research Service Agreement”).
Previous wording
The Vertex Research Service Agreement is for a two-year term; however, Vertex has the ability to terminate the agreement with a 30-day notice at any time. As a result, we concluded that the contract duration is 30 days, representing a month-to-month service contract. We recognize revenue associated with the Vertex Research Service Agreement over the performance period of the research services as the services are provided.
Current wording
The Vertex Research Service Agreement was for a two-year term, which expired in September 2025. We recognized revenue associated with the Vertex Research Service Agreement over the performance period of the research services as the services were provided.
Previous wording
We have not generated any revenue from product sales and do not expect to do so in the foreseeable future. Our ability to generate product revenue, if ever, will depend on the successful development and eventual commercialization of any product candidates that we identify. If we fail to complete the development of any future product candidates in a timely manner or to obtain regulatory approval for such product candidates, our ability to generate future revenue and our results of operations and financial position would be materially adversely affected. Our revenues to date have been exclusively related to research services. We recognize revenue as specified research services are performed and the results of the research and development services are provided to the customer.
Current wording
We have not generated any revenue from product sales and do not expect to do so in the foreseeable future. Our ability to generate product revenue, if ever, will depend on the successful development and eventual commercialization of any product candidates that we identify. If we fail to complete the development of any future product candidates in a timely manner or to obtain regulatory approval for such product candidates, our ability to generate future revenue and our results of operations and financial position would be materially adversely affected. Our revenues to date have been exclusively related to license and research and development ("R&D") services. Our license and research service revenue consists of amounts recognized from the portions of the non-refundable upfront payment and R&D services performed by us.
Previous wording
the timing and progress of preclinical and clinical development activities;
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the scope, timing and progress of preclinical and clinical development activities;
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maintaining a continued acceptable safety profile of the product candidates following approval.
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maintaining a continued acceptable safety profile of the product candidates following regulatory approval.
Previous wording
On July 4, 2025, the One Big Beautiful Bill Act (“H.R.1”) was signed into law, which introduced significant changes to the U.S. federal income tax code. Among other changes, H.R.1 makes permanent key elements of the Tax Cuts and Jobs Act, including restoring 100% bonus depreciation, eliminating the capitalization requirement for domestic research and development expenses, and modifying the business interest expense limitation, which now allows depreciation and amortization to be included in the limitation calculation. ASC 740 requires the effects of changes in tax rates and laws on deferred tax balances to be recognized in the period in which the legislation is enacted in the third quarter of 2025. We are in the process of evaluating H.R.1's impact on our condensed financial statements.
Current wording
On July 4, 2025, the One Big Beautiful Bill Act (“H.R.1”) was signed into law, which introduced significant changes to the U.S. federal income tax code. Among other changes, H.R.1 makes permanent key elements of the Tax Cuts and Jobs Act, including restoring 100% bonus depreciation, eliminating the capitalization requirement for domestic research and development expenses, and modifying the business interest expense limitation, which now allows depreciation and amortization to be included in the limitation calculation. ASC 740 requires the effects of changes in tax rates and laws on deferred tax balances to be recognized in the period in which the legislation is enacted in the third quarter of 2025. We are still in the process of evaluating H.R.1's impact on our condensed financial statements and an estimate of the financial impact cannot be made at this time. However, we do not expect the impact to be material to our condensed financial statements.
Previous wording
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
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Comparison of the Three and Nine Months Ended September 30, 2025 and 2024
Previous wording
We recorded service revenue of $0.1 million and $0.4 million for the three months ended June 30, 2025 and 2024, respectively. We recorded service revenue of $0.3 million and $0.7 million for the six months ended June 30, 2025 and 2024, respectively. Our service revenue was generated from research activities performed for Vertex in connection with the Vertex Research Service Agreement.
Current wording
Our revenue was generated from research activities performed for Novo in connection with the Novo Collaboration Agreement and Vertex in connection with the Vertex Research Service Agreement. We recorded revenue of $21.5 million and $0.2 million for the three months ended September 30, 2025 and 2024, respectively. We recorded revenue of $21.8 million and $0.9 million for the nine months ended September 30, 2025 and 2024, respectively.
Previous wording
Research and development expenses were $22.2 million and $15.0 million for the three months ended June 30, 2025 and 2024, respectively. The increase was primarily due to (i) $6.9 million of higher direct costs associated with our clinical and preclinical and research programs, (ii) $2.0 million of higher employee-related costs as a result of increased headcount as we continue to grow our business, and (iii) $0.8 million of higher facility-related and office costs as we expanded our office space in July 2024 to accommodate higher occupancy and larger operational activities, partially offset by $2.2 million of lower expenses attributable to unallocated external research and development costs and $0.4 million of lower other research and development expense.
Current wording
Research and development expenses were $24.3 million and $17.8 million for the three months ended September 30, 2025 and 2024, respectively. The increase was primarily due to (i) $6.6 million of higher direct costs associated with our clinical and preclinical and research programs, (ii) $3.6 million of higher employee-related costs as a result of increased headcount as we continue to grow our business, and (iii) $0.3 million of higher facility-related and office costs as we expanded our office space in July 2024 to accommodate higher occupancy and larger operational activities, partially offset by $4.1 million of lower expenses attributable to unallocated external research and development costs.
Previous wording
Research and development expenses were $41.5 million and $28.2 million for the six months ended June 30, 2025 and 2024, respectively. The increase was primarily due to (i) $12.7 million of higher direct costs associated with our clinical and preclinical and research programs, including $1.6 million of higher clinical trial expenses, (ii) $3.8 million of higher employee-related costs as a result of increased headcount as we continue to grow our business, and (iii) $1.5 million of higher facility-related and office costs as we expanded our office space in July 2024 to accommodate higher occupancy and larger operational activities, partially offset by $4.0 million of lower expenses attributable to unallocated external research and development costs and $0.8 million of lower other research and development expense.
Current wording
Research and development expenses were $65.7 million and $46.0 million for the nine months ended September 30, 2025 and 2024, respectively. The increase was primarily due to (i) $19.3 million of higher direct costs associated with our clinical and preclinical and research programs, including $2.3 million of higher clinical trial expenses, (ii) 7.4 million of higher employee-related costs as a result of increased headcount as we continue to grow our business, and (iii) $1.8 million of higher facility-related and office costs as we expanded our office space in July 2024 to accommodate higher occupancy and larger operational activities, partially offset by $8.1 million of lower expenses attributable to unallocated external research and development costs and $0.8 million of lower other research and development expense.
Previous wording
In February 2025, the SEP-786 clinical study was discontinued and, as a result, we do not anticipate incurring significant additional clinical trial costs associated with this study. We expect to continue to incur increased research and development expenses as we advance SEP-631 (MRGPRX2) into clinical development and continue to advance next-generation oral small molecule PTH1R agonists from our PTH1R program and other programs in our pipeline toward clinical development.
Current wording
In February 2025, the SEP-786 clinical study was discontinued and, as a result, we do not anticipate incurring significant additional clinical trial costs associated with this study. In September 2025, we announced the selection of SEP-479 as our next-generation oral small molecule PTH1R agonist development candidate and are now advancing SEP-479 through the completion of the remaining preclinical studies, manufacturing of clinical drug supply, and preparation of regulatory submissions in support of our plan to initiate a Phase 1 clinical trial for SEP-479 in the first half of 2026. We expect to continue to incur increased research and development expenses as we advance the ongoing clinical trial for SEP-631 towards completion, progress SEP-479 towards clinical development, continue to advance our TSHR NAM preclinical program and multiple discovery-stage programs in our pipeline, and continue to invest in our Native Complex Platform TM.
Previous wording
General and administrative expenses were $6.9 million and $3.4 million for the three months ended June 30, 2025 and 2024, respectively. The increase was primarily due to (i) $1.5 million of higher employee-related costs as a result of increased headcount to support our growing operations, (ii) $1.3 million of higher legal and consulting fees mainly attributable to costs associated with operating as a public company following our IPO in October 2024, (iii) $0.4 million of higher IT-related expenses, and (iv) $0.2 million of higher facility-related and office costs as we expanded our office space in July 2024 to accommodate higher occupancy and larger operational activities.
Current wording
General and administrative expenses were $7.1 million and $4.9 million for the three months ended September 30, 2025 and 2024, respectively. The increase was primarily due to (i) $1.5 million of higher employee-related costs as a result of increased headcount to support our growing operations, (ii) $0.5 million of higher IT-related expenses, (iii) $0.3 million of higher legal and consulting fees, and (iv) $0.2 million of higher facility-related and office costs as a result of increased operational activities and operating as a public company.
Previous wording
General and administrative expenses were $13.8 million and $6.1 million for the six months ended June 30, 2025 and 2024, respectively. The increase was primarily due to (i) $3.3 million of higher legal and consulting fees, mainly attributable to costs associated with operating as a public company following our IPO in October 2024, (ii) $2.9 million of higher employee-related costs as a result of increased headcount to support our growing operations, (iii) $0.8 million of higher IT-related expenses, and (iv) $0.3 million of higher facility-related and office costs as we expanded our office space in July 2024 to accommodate higher occupancy and larger operational activities.
Current wording
General and administrative expenses were $20.9 million and $10.9 million for the nine months ended September 30, 2025 and 2024, respectively. The increase was primarily due to (i) $4.4 million of higher employee-related costs as a result of increased headcount, (ii) $2.2 million of higher legal and consulting fees, (iii) $1.0 million of accounting and consulting fees, (iv) $1.3 million of higher
Previous wording
Interest income was $4.2 million and $1.5 million for the three months ended June 30, 2025 and 2024, respectively. Interest income was $8.6 million and $2.8 million for the six months ended June 30, 2025 and 2024, respectively. The increases in interest income for the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024, respectively, were due to higher interest rates and higher balances of invested cash in cash equivalents and marketable securities.
Current wording
Interest income was $5.6 million and $1.9 million for the three months ended September 30, 2025 and 2024, respectively. Interest income was $14.2 million and $4.7 million for the nine months ended September 30, 2025 and 2024, respectively. The increases in interest income for the three and nine months ended September 30, 2025 as compared to the three and nine months ended September 30, 2024, respectively, were due to higher interest rates and higher balances of invested cash in cash equivalents and marketable securities.
Previous wording
We recognized $0.1 million and $0.2 million of benefit for income taxes for the three and six months ended June 30, 2024, respectively. We did not record any benefit or provision for income taxes for the three and six months ended June 30, 2025.
Current wording
We recognized $0.1 million and $0.3 million of benefit for income taxes for the three and nine months ended September 30, 2024, respectively. We did not record a benefit or provision for income taxes for the three and nine months ended September 30, 2025.
Previous wording
Our net losses were $46.3 million and $30.6 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $164.7 million. Since our founding, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, developing our proprietary and structure-based drug discovery platform, identifying and discovering our product candidates, establishing our intellectual property portfolio, conducting research and preclinical studies, including IND-enabling studies, initiating and conducting clinical trials, establishing arrangements with third parties for the manufacture of our product candidates and related raw materials, and providing general and administrative support for these operations. We expect to continue to incur substantial expenditures for our research and development programs.
Current wording
Our net losses were $38.1 million and $51.1 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $156.5 million. Since our founding, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, developing our proprietary and structure-based drug discovery platform, identifying and discovering our product candidates, establishing our intellectual property portfolio, conducting research and preclinical studies, including IND-enabling studies, initiating and conducting clinical trials, establishing arrangements with third parties for the manufacture of our product candidates and related raw materials, and providing general and administrative support for these operations. We expect to continue to incur substantial expenditures for our research and development programs.
Previous wording
We historically financed our operations primarily through the issuances of convertible promissory notes and convertible preferred stock, and most recently, through an IPO. In October 2024, we completed our IPO, pursuant to which we issued and sold an aggregate of 18.4 million shares of common stock (inclusive of 2.4 million shares of common stock sold pursuant to the underwriters' exercise of their option to purchase additional shares in full). The aggregate net proceeds received by us from the IPO was $302.8 million, net of total offering costs of $28.4 million.
Current wording
We have historically financed our operations primarily through the issuances of convertible promissory notes and convertible preferred stock, and most recently, through an IPO. In October 2024, we completed our IPO, pursuant to which we issued and sold an aggregate of 18.4 million shares of common stock (inclusive of 2.4 million shares of common stock sold pursuant to the underwriters' exercise of their option to purchase additional shares in full). The aggregate net proceeds received by us from the IPO was $302.8 million, net of total offering costs of $28.4 million.
Previous wording
In July 2025, upon the effectiveness of the Novo Collaboration Agreement, we received an upfront payment of $195.0 million. We believe our cash, cash equivalents and marketable securities of $379.2 million as of June 30, 2025, together with the upfront payment of $195.0 million from the Novo Collaboration Agreement and the milestone payment of $12.5 million from the Vertex Asset Purchase Agreement, will be sufficient to fund our operations and capital expenditure requirements at least into 2029.
Current wording
In July 2025, upon the effectiveness of the Novo Collaboration Agreement, we received a one-time, non-refundable upfront payment of $195.0 million. In August 2025, we received a $12.5 million milestone payment from the Vertex Asset Purchase Agreement. We believe our cash, cash equivalents and marketable securities of $561.6 million as of September 30, 2025 will be sufficient to fund our operations and capital expenditure requirements at least into 2029.
Previous wording
The net cash used in operating activities for the six months ended June 30, 2024 was due to our net loss of $30.6 million and $1.0 million of net change in operating assets and liabilities, partially offset by $1.9 million of non-cash charges for depreciation and amortization, stock-based compensation, non-cash operating lease expense, deferred income tax and accretion of discounts, net, on marketable securities.
Current wording
Net cash provided by operating activities was $125.2 million for the nine months ended September 30, 2025. The net cash provided by operating activities for the nine months ended September 30, 2025 was due to $169.8 million of net change in operating assets and liabilities, partially offset by $38.1 million of net loss, net non-cash charges of $6.5 million primarily attributable to gain on sale of non-financial asset and amortization of premiums (discounts), net.
Previous wording
Net cash used in operating activities was $43.6 million and $29.7 million for the six months ended June 30, 2025 and 2024, respectively. The net cash used in operating activities for the six months ended June 30, 2025 was due to our net loss of $46.3 million and a $0.5 million of net change in operating assets and liabilities, partially offset by $3.2 million of non-cash charges for depreciation and amortization, stock-based compensation, non-cash operating lease expense, and accretion of discounts, net, on marketable securities.
Current wording
Net cash used in operating activities was $46.5 million for the nine months ended September 30, 2024. The net cash used in operating activities for the nine months ended September 30, 2024 was due to our net loss of $51.1 million, partially offset by $1.7 million of net change in operating assets and liabilities, $2.9 million of non-cash charges for depreciation and amortization, stock-based compensation, non-cash operating lease expense, deferred income tax and accretion of discounts, net, on marketable securities.
Previous wording
Net cash used in investing activities of $5.7 million for the six months ended June 30, 2025 was attributable to $113.6 million of purchases of marketable securities and $0.4 million of purchases of property and equipment, partially offset by the maturity of $108.3 million of marketable securities.
Current wording
Net cash used in investing activities of $44.1 million for the nine months ended September 30, 2025 was attributable to $223.5 million of purchases of marketable securities and $0.5 million of purchases of property and equipment, partially offset by the maturity of $167.4 million of marketable securities and the receipt of the $12.5 million milestone payment related to the Vertex Asset Purchase Agreement.
Previous wording
Net cash used in investing activities of $2.6 million for the six months ended June 30, 2024 was attributable to $32.2 million of purchases of available-for-sale marketable securities and $0.9 million of purchases of property and equipment, partially offset by the receipt of the remaining $22.6 million from the sale of non-financial asset during the year ended December 31, 2023 and the maturity of $7.9 million of available-for-sale marketable securities.
Current wording
Net cash used in investing activities of $27.4 million for the nine months ended September 30, 2024 was attributable to $65.8 million of purchases of available-for-sale marketable securities and $1.5 million of purchases of property and equipment, partially offset by the receipt of the remaining $22.6 million from the sale of non-financial asset during the year ended December 31, 2023 and the maturity of $17.3 million of available-for-sale marketable securities.
Previous wording
Net cash provided by financing activities of $0.4 million for the six months ended June 30, 2025 was attributable to the proceeds from the exercise of stock options.
Current wording
Net cash provided by financing activities of $0.7 million for the nine months ended September 30, 2025 was primarily attributable to the proceeds from the exercise of stock options.
Previous wording
Net cash provided by financing activities of $75.0 million for the six months ended June 30, 2024 was primarily attributable to the net proceeds from the sale and issuance of our Series B convertible preferred stock.
Current wording
Net cash provided by financing activities of $73.6 million for the nine months ended September 30, 2024 was primarily attributable to the net proceeds from the sale and issuance of our Series B convertible preferred stock.
Previous wording
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of private and public equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, existing stockholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect existing stockholders’ rights as common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Current wording
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of private and public equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. However, the trading prices for our common stock and for other biopharmaceutical companies have been highly volatile. As a result, we may face difficulties raising capital through sales of our common stock, and such sales may be on unfavorable terms. Similarly, adverse macroeconomic conditions and market volatility resulting from global and national economic developments, political unrest, high inflation, disruptions in capital markets, changes in international trade relationships, changes in or the disruptions of U.S. governmental agencies, whether from a continued U.S. federal government shutdown or reduced resources, global health crises, or other factors could materially and adversely affect our ability to consummate an equity or debt financing on favorable terms or at all. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, existing stockholders’ ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect existing stockholders’ rights as common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Previous wording
During the six months ended June 30, 2025, there have been no material changes to our critical accounting policies and estimates as described in our Annual Report.
Current wording
During the nine months ended September 30, 2025, there have been no material changes to our critical accounting policies and estimates as described in our Annual Report, except as described below.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
$21.3 million of our total revenue for the three and nine months ended September 30, 2025 was generated from research activities performed for Novo in connection with the Novo Collaboration Agreement while the remainder was generated from research activities performed for Vertex in connection with the Vertex Research Service Agreement.
Current report — wording carried from elsewhere
Gain on Sale of Non-Financial Asset
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Net Cash Used in Operating Activities