What changed in Septerna, Inc.'s 10-K — 2024 vs 2025
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Paragraph-level year-over-year comparison of Septerna, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.
+124 added−104 removedSource: 10-K (2026-03-09) vs 10-K (2025-03-27)
Top changes in Septerna, Inc.'s 2025 10-K
124 paragraphs added · 104 removed · 69 edited across 4 sections
- Item 7. Management's Discussion & Analysis+116 / −96 · 61 edited
- Item 5. Market for Registrant's Common Equity+4 / −4 · 4 edited
- Item 1C. Cybersecurity+3 / −3 · 3 edited
- Item 3. Legal Proceedings+1 / −1 · 1 edited
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
3 edited+0 added−0 removed9 unchanged
Item 1C. Cybersecurity
Cybersecurity — threats and controls disclosure
3 edited+0 added−0 removed9 unchanged
2024 filing
2025 filing
Biggest changeSuch briefings may include a discussion of cybersecurity risks and applicable risk assessments, key updates regarding our cyber strategy and related initiatives, and the emerging cybersecurity threats that may impact our business. We also provided the full board of directors with updates on matters relating to cybersecurity risk management, as necessary. 100
Biggest changeSuch briefings may include a discussion of cybersecurity risks and applicable risk assessments, key updates regarding our cyber strategy and related initiatives, and the emerging cybersecurity threats that may impact our business. We also provided the full board of directors with updates on matters relating to cybersecurity risk management, as necessary.
Our cybersecurity risk assessment and management processes are implemented and maintained by our General Administrative Leadership team, which consists of our CEO, CFO, COO, CPO, Vice President of Finance and Business, Vice President of Technology and our Head of Information Technology (“IT”), and is responsible for the strategic leadership of our cybersecurity risk management program.
Our cybersecurity risk assessment and management processes are implemented and maintained by our General Administrative Leadership team, which consists of our CEO, CFO, COO, CPO, CLO, Vice President of Finance and Business, Vice President of Technology and our Head of Information Technology (“IT”), and is responsible for the strategic leadership of our cybersecurity risk management program.
For more information, please see “Item 1A, Risk Factors.” Governance Related to Cybersecurity Risks Our board of directors has delegated cybersecurity risk management to our Audit Committee as part of the Audit Committee’s general risk oversight function.
For more information, please see “Item 1A, Risk Factors.” Governance Related to Cybersecurity Risks 98 Our board of directors has delegated cybersecurity risk management to our Audit Committee as part of the Audit Committee’s general risk oversight function.
Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
1 edited+0 added−0 removed1 unchanged
Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
1 edited+0 added−0 removed1 unchanged
2024 filing
2025 filing
Biggest changeRegardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors. Item 4. Mine S afety Disclosures. Not applicable. 101 PAR T II
Biggest changeRegardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors. Item 4. Mine S afety Disclosures. Not applicable. 99 PAR T II
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
4 edited+0 added−0 removed14 unchanged
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
4 edited+0 added−0 removed14 unchanged
2024 filing
2025 filing
Biggest changeAs a result, we currently expect to use our cash, cash equivalents and marketable securities, which include the net proceeds from the IPO, to advance a next-generation oral small molecule PTH1R agonist from our PTH1R program into clinical development, advance SEP-631 into clinical development, continue to advance the other programs in our pipeline, and the remainder to fund working capital and other general corporate purposes.
Biggest changeAs a result, we currently expect to use our cash, cash equivalents and marketable securities, which include the net proceeds from the IPO, to advance SEP-479 and SEP-631 in clinical development, continue to advance the other programs in our pipeline, and the remainder to fund working capital and other general corporate purposes.
We incurred $0.1 million in issuance costs. 102 No underwriters were involved in the foregoing sale of securities. The sale of securities described above were deemed to be exempt from registration pursuant to Section 4(a)(2) of the Securities Act, including Regulation D and Rule 506 promulgated thereunder, as transactions by an issuer not involving a public offering.
We incurred $0.1 million in issuance costs. 100 No underwriters were involved in the foregoing sale of securities. The sale of securities described above were deemed to be exempt from registration pursuant to Section 4(a)(2) of the Securities Act, including Regulation D and Rule 506 promulgated thereunder, as transactions by an issuer not involving a public offering.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. Item 6. [ Reserved] 103
Purchases of Equity Securities by the Issuer and Affiliated Purchasers None. Item 6. [ Reserved] 101
Common Stock Holders As of March 17, 2025, we had approximately 103 holders of record of our common stock.
Common Stock Holders As of March 2, 2026, we had approximately 60 holders of record of our common stock.
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
61 edited+55 added−35 removed44 unchanged
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
61 edited+55 added−35 removed44 unchanged
2024 filing
2025 filing
Biggest changeThis is due to the numerous risks and uncertainties associated with developing product candidates, many of which are outside of our control, including the uncertainty of: • the timing and progress of preclinical and clinical development activities; • the number and scope of preclinical and clinical programs we decide to pursue; • our ability to maintain our current research and development programs and to establish new ones; • establishing an appropriate safety profile with IND-enabling studies; • the number of sites and patients included in the clinical trials; 107 • the countries in which the clinical trials are conducted; • per patient trial costs; • successful patient enrollment in, and the initiation of, clinical trials, as well as drop out or discontinuation rates; • the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the U.S.
Biggest changeThis is due to the numerous risks and uncertainties associated with developing product candidates, many of which are outside of our control, including the uncertainty of: • the scope, timing and progress of preclinical and clinical development activities; • the number and scope of preclinical and clinical programs we decide to pursue; • our ability to maintain our current research and development programs and to establish new ones; • establishing an appropriate safety profile with IND-enabling studies;the number of sites and patients included in the clinical trials; • the number of sites and patients included in the clinical trials; • the countries in which the clinical trials are conducted; • our ability to replicate positive results from a completed clinical study in a future clinical study; • per patient trial costs; • successful patient enrollment in, and the initiation of, clinical trials, as well as drop out or discontinuation rates; • the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to FDA, EMA, or any other comparable foreign regulatory authorities; • 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; • the number of trials required for regulatory approval; • the timing, receipt and terms of any regulatory approvals from applicable regulatory authorities; • 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; • the performance of any current or future collaborators; • the performance of any current or future collaborators; • establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; 106 • significant and changing government regulation and regulatory guidance; • the impact of any business interruptions to our operations or to those of the third parties with whom we work; • obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights; • launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; and • maintaining a continued acceptable safety profile of the product candidates following regulatory approval.
We could be an emerging growth company until the earliest to occur: (i) the last day of the fiscal year in which we have more than $1.235 115 billion in annual gross revenue; (ii) the date we qualify as a “large accelerated filers” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), with at least $700.0 million of equity securities held by non-affiliates; (iii) the issuance, in any three-year period, by us of more than $1.0 billion in non-convertible debt securities; or (iv) the last day of the fiscal year ending after the fifth anniversary of our IPO.
We could be an emerging growth company until the earliest to occur: (i) the last day of the fiscal year in which we have more than $1.235 billion in annual gross revenue; (ii) the date we qualify as a “large accelerated filers” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), with at least $700.0 million of equity securities held by non-affiliates; (iii) the issuance, in any three-year period, by us of more than $1.0 billion in non-convertible debt securities; or (iv) the last day of the fiscal year ending after the fifth anniversary of our IPO.
We expect that our research and development expenses will increase substantially in absolute dollars for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, as our product candidates advance into later stages of development, as we begin to conduct clinical trials, as we seek regulatory approvals for any product candidates that successfully complete clinical trials, and as we incur expenses associated with hiring additional personnel to support our research and development efforts.
We expect that our research and development expenses will increase substantially in absolute dollars for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, as our product candidates advance into later stages of development, as we begin to conduct new clinical trials, as we seek regulatory approvals for any product candidates that successfully complete clinical trials, and as we incur expenses associated with hiring additional personnel to support our research and development efforts.
The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods.
GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods.
The net cash used in operating activities for the year ended December 31, 2024 was due to our net loss of $71.8 million, which was partially offset by (i) $4.1 million of non-cash charges for depreciation and amortization, stock-based compensation, non-cash operating lease expense, deferred income tax and accretion of premiums (discounts) on marketable securities, and (ii) $0.2 million of net change in operating assets and liabilities.
Net cash used in operating activities for the year ended December 31, 2024 was due to our net loss of $71.8 million, which was partially offset by (i) $4.1 million of non-cash charges for depreciation and amortization, stock-based compensation, non-cash operating lease expense, deferred income tax and accretion of premiums (discounts) on marketable securities and other adjustments, and (ii) $0.2 million of net change in operating assets and liabilities.
As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
As a result, our financial statements may not be comparable to 114 companies that comply with new or revised accounting pronouncements as of public company effective dates.
We estimate accrued research and development expenses as of each balance sheet date based on facts and circumstances known at that time. We periodically confirm the accuracy of our estimates with internal management personnel and external service providers, and makes adjustments, if necessary.
We estimate accrued research and development expenses as of each balance sheet date based on facts and circumstances known at that time. We periodically confirm the accuracy of its estimates with internal management personnel and external service providers, and makes adjustments, if necessary.
Payments made prior to the receipt of goods and services to be used in research and development are deferred and recognized as expense in the period in which the related goods are received or services are rendered. We have entered into various agreements with outsourced contract manufacturing and development vendors.
Payments made prior to the receipt of goods and services to be used in research and development are deferred and recognized as expense in the period in which the related goods are received or services are rendered. We have entered into agreements with outsourced contract manufacturing and development and clinical research vendors.
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.
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 drug candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases.
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.
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 research and development expenses consist of: • Direct costs, including: ▪ preclinical and research program costs, which include external research and development costs related to (i) the production of preclinical materials, including fees and milestones paid to contract manufacturers and (ii) agreements with contract development organizations, consultants and other third-party contract organizations to conduct our preclinical studies and other research and development activities on our behalf, costs incurred in connection with laboratory operations, materials and supplies, and other preclinical studies; ▪ clinical program costs, which include external costs to conduct clinical trials, including costs paid to contract research organizations (“CROs”), the production of clinical materials and fees paid to contract manufacturers, costs incurred in connection with clinical laboratory operations, materials and supplies; and • unallocated costs, including: ▪ payroll-related costs, including salaries, benefits and stock-based compensation for employees engaged in research and development activities; ▪ external research and development costs, including contract research and development and professional service fees for consulting and related services; ▪ facility-related and office costs, including lease/rent, building-related expenses, facility-related overhead, and depreciation expense; and ▪ other costs, including expenses related to our funded, sponsored research activities and technology licenses, laboratory operations, information technology (“IT”)-related expenses.
Our research and development expenses consist of: • Direct costs, including: ▪ clinical program costs, which include external costs to conduct clinical trials, including costs paid to contract research organizations (“CROs”), the production of clinical materials and fees paid to contract manufacturers, costs incurred in connection with clinical laboratory operations, materials and supplies; ▪ preclinical and research program costs, which include external research and development costs related to (i) the production of preclinical materials, including fees and milestones paid to contract manufacturers and (ii) agreements with contract development organizations, consultants and other third-party contract organizations to conduct our preclinical studies and other research and development activities on our behalf, costs incurred in connection with laboratory operations, materials and supplies, and other preclinical studies; and • unallocated costs, including: ▪ payroll-related costs, including salaries, benefits and stock-based compensation for employees engaged in research and development activities; 105 ▪ external research and development costs, including contract research and development and professional service fees for consulting and related services; ▪ facility-related and office costs, including lease/rent, building-related expenses, facility-related overhead, and depreciation expense; and ▪ other costs, including expenses related to our funded, sponsored research activities and technology licenses, laboratory operations, information technology (“IT”)-related expenses We expense all research and development costs in the periods in which they are incurred.
Future Funding Requirements Our primary use of cash is to fund our operations, primarily research and development expenditures. Cash used for operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.
Future Funding Requirements Our primary use of cash, cash equivalents, and marketable securities is to fund our operations, primarily research and development expenditures. Cash, cash equivalents, and marketable securities used for operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.
Research and development expenses consist primarily of employee-related costs, including salaries, benefits, and stock-based compensation for employees engaged in research and development activities, costs related to research activities, preclinical studies and clinical trials, production of preclinical and clinical materials, IT-related costs, allocated overhead costs including facility-related expenses, contract manufacturing, consulting fees, costs related to laboratory operations, and fees paid to other entities that conduct certain research and development activities on our behalf.
Research and development expenses consist primarily of employee-related costs, including salaries, benefits and stock-based compensation for employees engaged in research and development activities, costs related to research activities, preclinical studies and clinical trials, contract manufacturing for the production of clinical and preclinical materials, information technology-related costs, allocated overhead costs including facility-related expenses, consulting fees, costs related to laboratory operations and fees paid to other entities that conduct certain research and development activities on our behalf.
Other Income (Expense), Net Other income (expense), net consists primarily of changes in the fair value of our cash equivalents held in money market funds, loss on disposal of our fixed assets and foreign currency transaction gain or loss. Benefit (Provision) for Income Taxes We are subject to corporate United States federal and state income taxation.
Other Income (Expense), Net Other income (expense), net consists primarily of changes in the fair value of our cash equivalents held in money market funds, loss on disposal of our fixed assets and foreign currency transaction gain or loss. Benefit (Provision) for Income Taxes We are subject to corporate U. S. federal and state income taxation.
We expect to continue to incur significant and increasing net operating losses for the next several years as we: • continue to advance our product candidates through preclinical studies and into clinical trials; • attract, hire and retain additional personnel; • operate as a public company, including expenses related to compliance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and those of any national securities exchange on which our securities are traded, legal, auditing, additional insurance expenses, investor relations activities, and other administrative and professional services; • continue our research and development efforts and expand our pipeline of product candidates; • acquire, discover, validate, and develop additional product candidates; • require the manufacture of supplies for our preclinical studies and clinical trials; • obtain, maintain, expand, and protect our intellectual property portfolio; • implement operational, financial and information management systems; • make royalty, milestone or other payments under any future, license or collaboration agreements; • potentially seek to identify, assess, acquire, or in-license or develop new technologies or additional product candidates; • potentially experience any delays, challenges, or other issues associated with the clinical development of our product candidates, including with respect to our regulatory strategies; • pursue regulatory approval of product candidates that successfully complete clinical trials; and • establish a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain marketing approval and related commercial manufacturing build-out.
We expect to continue to incur significant and increasing net operating losses for the next several years as we: • continue to advance our product candidates through preclinical studies and into clinical trials; • attract, hire and retain additional personnel; • continue to operate as a public company, including expenses related to compliance with the rules and regulations of the SEC and those of any national securities exchange on which our securities are traded, legal, auditing, insurance expenses, investor relations activities, and other administrative and professional services; • continue our research and development efforts and expand our pipeline of product candidates; • acquire, discover, validate, and develop additional product candidates; • manufacture supplies for our preclinical studies and clinical trials; • obtain, maintain, expand, and protect our intellectual property portfolio; • implement operational, financial and information management systems; • make royalty, milestone or other payments under any future, license or collaboration agreements; • potentially seek to identify, assess, acquire, or in-license or develop new technologies or additional product candidates; • potentially experience any delays, challenges, or other issues associated with the clinical development of our product candidates, including with respect to our regulatory strategies; • pursue regulatory approval of product candidates that successfully complete clinical trials; and • establish a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain marketing approval and related commercial manufacturing build-out. 103 Our net losses may fluctuate significantly from period to period, depending upon the timing of our expenditures on research and development activities.
Our provision (benefit) for income taxes are recorded in accordance with Accounting Standard Codification (“ASC”) 740, Accounting for Income Taxes , which provides for deferred taxes using an asset and liability approach. We establish a valuation allowance against all of our net deferred tax assets.
Our benefit for income taxes is recorded in accordance with Accounting Standard Codification 740, Accounting for Income Taxes, which provides for deferred taxes using an asset and liability approach. We establish a valuation allowance against all of our net deferred tax assets.
See the section titled “Liquidity and Capital Resources - Future Funding Requirements” below for additional information. We historically financed our operations primarily through the issuances of convertible promissory notes and convertible preferred stock, and, most recently, through an initial public offering (“IPO”).
See the section titled “Liquidity and Capital Resources - Future Funding Requirements” below for additional information. We historically financed our operations primarily through the issuances of convertible promissory notes and convertible preferred stock, an initial public offering (“IPO”), and collaborations with other companies.
Forfeitures are accounted for in the period in which they occur. 113 In determining the fair value of the options granted, we use the Black Scholes option pricing model and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment to determine.
Forfeitures are accounted for in the period in which they occur. In determining the fair value of the options granted and Employee Stock Purchase Plan (“ESPP”) shares, we use the Black-Scholes option pricing model and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment to determine.
As of December 31, 2024, we had an accumulated deficit of $118.4 million. We have incurred net losses in each year since inception, except for the year ended December 31, 2023. We expect to continue to incur net losses for the foreseeable future.
As of December 31, 2025, we had an accumulated deficit of $167.3 million. We have incurred net losses in each year since inception, except for the year ended December 31, 2023. We expect to continue to incur net losses for the foreseeable future.
We recognize revenue associated with the Vertex service agreement over the performance period of the research services as the services are provided. Components of Results of Operations Revenue We have not generated any revenue from product sales and do not expect to do so in the foreseeable future.
We recognized revenue associated with the Vertex Research Service Agreement over the performance period of the research services as the services were provided. The Vertex Research Service Agreement expired in September 2025. Components of Results of Operations Revenue 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 will depend on the successful development and eventual commercialization of one or more of our product candidates. Our net loss was $71.8 million for the year ended December 31, 2024 compared to net income of $4.2 million for the year ended December 31, 2023.
Our ability to generate product revenue will depend on the successful development and eventual commercialization of one or more of our product candidates. Our net loss was $48.9 million for the year ended December 31, 2025 compared to net loss of $71.8 million for the year ended December 31, 2024.
Our future funding requirements will depend on many factors, including, but not limited to: • the scope, timing, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates; • the expenses of manufacturing our product candidates for clinical trials and in preparation for marketing approval and commercialization; • the extent to which we enter into collaborations or other arrangements with additional third parties in order to further develop our product candidates; • the expenses of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; • the expenses and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies; • our ability to establish additional collaborations on favorable terms, if at all; • the expenses required to scale up our clinical, regulatory and manufacturing capabilities; • the expenses of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities, for any of our product candidates for which we receive marketing approval; and • revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval.
Our future funding requirements will depend on many factors, including, but not limited to: • the scope, timing, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates; 110 • our ability to successfully develop, obtain regulatory and marketing approvals of our product candidates for the expected indications and patient populations; • the expenses of manufacturing our product candidates for clinical trials and in preparation for marketing approval and commercialization; • our ability to maintain existing collaborations or strategic relationships and the extent to which we identify and enter into future collaborations or other arrangements with additional third parties in order to further develop our product candidates, as well as our ability to realize the intended and potential benefits of such agreements and collaborations; • regulatory or legal developments in the United States and other countries; • the expenses of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; • the expenses and fees associated with the discovery, acquisition or in-license of additional product candidates or technologies; • our ability to establish additional collaborations on favorable terms, if at all; • the expenses required to scale up our clinical, regulatory and manufacturing capabilities; • the expenses of future commercialization activities, if any, including establishing sales, marketing, manufacturing and distribution capabilities, for any of our product candidates for which we receive marketing approval; and • revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval.
Please also see the section titled “Special Note Regarding Forward-Looking Statements.” Overview 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.
Please also see the section titled “Special Note Regarding Forward-Looking Statements.” Overview We are a clinical-stage biotechnology company pioneering a new era of GPCR oral small molecule drug discovered powered by our proprietary Native Complex Platform®.
Fair Value of Common Stock — See the subsection titled “—Fair Value of Common Stock” below. Expected Term — The expected term represents the period that our stock options granted are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term).
Expected Term — The expected term represents the period that our stock options granted are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term).
Liquidity and Capital Resources Sources of Liquidity Our net loss was $71.8 million for the year ended December 31, 2024 compared to $4.2 million of net income for the year ended December 31, 2023. As of December 31, 2024, we had an accumulated deficit of $118.4 million.
Liquidity and Capital Resources Sources of Liquidity Our net loss was $48.9 million for the year ended December 31, 2025 compared to $71.8 million of net loss for the year ended December 31, 2024. As of December 31, 2025, we had an accumulated deficit of $167.3 million.
General and Administrative General and administrative expenses were $16.6 million and $9.7 million for the years ended December 31, 2024 and 2023, respectively.
General and Administrative General and administrative expenses were $29.2 million and $16.6 million for the years ended December 31, 2025 and 2024, respectively.
We expense all research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and third-party service providers.
Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and third-party service providers. A significant portion of our research and development costs have been external costs, which we track by stage of development.
The increase of $29.4 million was primarily due to (i) $10.0 million of higher expenses attributable to unallocated external research and development costs, (ii) $7.4 million of higher direct costs associated with our SEP-786 clinical, preclinical and research program, including $2.4 million of clinical trial expenses, (iii) $5.4 million of higher employee-related costs as a result of increased headcount as we grow our business, (iv) $3.2 million of higher facility-related and office costs as we expanded our office space to accommodate higher occupancy and larger operational activities, and (v) an increase of $1.7 million in other research and development expense, primarily driven by higher IT operational expenses.
The increase of $32.2 million was primarily due to (i) $22.3 million of higher direct costs attributable to increased spending with our other programs, (ii) $10.1 million of higher direct costs associated with our MRGPRX2 program, including an increase of $6.9 million in external clinical development expenses, (iii) $9.9 million of higher employee-related costs as a result of increased headcount as we grow our business, (iv) $2.0 million of higher facility-related and office costs as we expanded our office space to accommodate 108 higher occupancy and larger operational activities and (v) $1.2 million of increased direct costs associated with our PTH1R program.
Net cash used in operating activities was $38.7 million for the years ended December 31, 2023.
Net cash used in operating activities was $67.5 million for the years ended December 31, 2024.
Vertex Asset Purchase and Service Agreements Asset Purchase Agreement In September 2023, we entered into an asset purchase agreement with Vertex Pharmaceuticals Incorporated (“Vertex”) for a total of $47.6 million under which Vertex acquired all of our IPR&D asset related to a GPCR program, including all intellectual property, materials, and compounds associated with the program (“Vertex purchase agreement”).
See Note 4 to the financial statements included elsewhere in this Annual Report for additional information. 104 Vertex Asset Purchase and Research Service Agreement Vertex Asset Purchase Agreement In September 2023, we entered into an asset purchase agreement with Vertex for a total of $47.6 million under which Vertex acquired all of our IPR&D asset related to a GPCR program, including all intellectual property, materials, and compounds associated with the program (“Vertex Asset Purchase Agreement”).
A significant portion of our research and development costs have been external costs, which we track by stage of development. However, we do not track our unallocated costs on a program specific basis because these costs are deployed across multiple projects and, as such, are not separately classified.
However, we do not track our unallocated costs on a program specific basis because these costs are deployed across multiple projects and, as such, are not separately classified.
Since our inception, we have devoted substantially all of our resources to raising capital, organizing and staffing our company, business and scientific planning, conducting discovery and research and development activities, establishing, maintaining, and protecting our intellectual property portfolio, developing and progressing our product candidates and preparing for clinical trials, establishing arrangements with third parties for the manufacture of our product candidates and component materials, engaging in collaboration activities, and providing general and administrative support for these operations.
Since our inception, we have devoted substantially all of our resources to raising capital, organizing and staffing our company, business and scientific planning, conducting discovery and research and development activities, establishing, maintaining, and protecting our intellectual property portfolio, developing and progressing our product candidates and preparing for clinical trials, establishing arrangements with third parties for the manufacture of our product candidates and component materials, engaging in collaboration activities, and providing general and administrative support for these operations. 111 Critical Accounting Policies and Use of Estimates Management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“U.S.
Additionally, we utilize third-party contract manufacturing organizations (“CMOs”), to manufacture and supply our preclinical and clinical materials during the development of our product candidates. We expect to use similar contract resources for the commercialization of our products, at least until our resources and operations are at a scale that justifies investment in internal manufacturing capabilities.
We expect to use similar contract resources for the commercialization of our products, at least until our resources and operations are at a scale that justifies investment in internal manufacturing capabilities.
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.
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. 102 Financial Overview We were incorporated in Delaware in December 2019 under the name GPCR NewCo, Inc.
We consider revenue to be earned when all of the following criteria are met: (i) we have a contract with a customer that creates enforceable rights and obligations; (ii) promised products or services are identified; (iii) the transaction price, or the amount we expect to receive, including an estimate of uncertain amounts subject to a constraint to ensure revenue is not recognized in an amount that would result in a significant reversal upon resolution of the uncertainty, is determinable; (iv) and we have transferred control of the promised items to the customer.
To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following four steps: (i) confirm we have a contract with a customer that creates enforceable rights and obligations; (ii) identify promised products or services to be transferred to a customer; (iii) determine the transaction price, or the amount it expects to receive, including an estimate of uncertain amounts subject to a constraint to ensure revenue is not recognized in an amount that would result in a significant reversal upon resolution of the uncertainty, is determinable and allocated to the performance obligations; and (iv) recognize revenue when or as performance obligations are satisfied.
After the potential milestone payment, we will not receive any other payments or future royalties related to this IPR&D asset. Service Agreement In addition to the Vertex purchase agreement, we also entered into a research service agreement with Vertex (“Vertex service agreement”) under which we agreed to perform certain exploratory research activities for Vertex.
Subsequently, there are no additional payments related to this IPR&D asset. Vertex Research Service Agreement In addition to the Vertex purchase agreement, we also entered into a research service agreement with Vertex (“Vertex Research Service Agreement”) under which we agreed to perform certain exploratory research activities for Vertex.
The aggregate net proceeds received by us from the IPO was $302.8 million, after deducting underwriting discounts and commissions, and other offering costs payable by us of $28.4 million.
The aggregate net proceeds received by us from the IPO was $302.8 million, after deducting underwriting discounts and commissions, and other offering costs payable by us of $28.4 million. In July 2025, upon the effectiveness of the Novo Collaboration Agreement, we received a one-time, non-refundable upfront payment of $195.0 million.
The increase was due to higher interest rates and higher balances of invested cash in cash equivalents and marketable securities. 110 (Benefit) Provision for Income Taxes We recognized $0.5 million of benefit for income taxes for the year ended December 31, 2024.
Other Income, Net Interest Income Interest income was $19.5 million and $8.6 million for the years ended December 31, 2025 and 2024, respectively. The increase in interest income was due to higher average balances of invested cash in cash equivalents and marketable securities.
Gain on Sale of Non-Financial Asset Gain on sale of non-financial asset of $47.6 million was attributable to the sale of our IPR&D asset related to a GPCR program to Vertex during the year ended December 31, 2023. No gain on sale of non-financial asset was recorded during the year ended December 31, 2024.
Gain on Sale of Non-Financial Asset Gain on sale of non-financial asset of $12.5 million during the year ended December 31, 2025 was attributable to a milestone payment under the Vertex Asset Purchase Agreement. No gain on sale of non-financial asset was recorded during the year ended December 31, 2024.
Net cash used in operating activities for the year ended December 31, 2023 was attributable to $47.6 million of non-cash adjustment related to gain on sale of non-financial asset, partially offset by (i) our net income of $4.2 million, (ii) $3.8 million of non-cash charges for depreciation and amortization, stock-based compensation, non-cash operating lease expense and deferred income tax, and (iii) $0.9 million of net change in operating assets and liabilities. 111 Net Cash (Used in) Provided by Investing Activities Net cash used in investing activities of $160.6 million for the year ended December 31, 2024 was due to $213.4 million of purchases of marketable securities and $2.1 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 in 2023 and the maturity of $32.3 million of marketable securities.
Net Cash Used in Investing Activities Net cash used in investing activities of $229.4 million for the year ended December 31, 2025 was due to $451.0 million of purchases of marketable securities and $0.5 million of purchases of property and equipment, partially offset by the maturity of $209.6 million of marketable securities and the receipt of the $12.5 million milestone payment related to the Vertex Asset Purchase Agreement Net cash provided by investing activities of $160.6 million for the year ended December 31, 2024 was due to $213.4 million of purchases of marketable securities and $2.1 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 in 2023 and the maturity of $32.3 million of marketable securities.
Of the $47.6 million, $25.0 million was received in cash in September 2023 and the remainder during the year ended December 31, 2024. Additionally, as part of the agreement, Vertex assumed all claims, counterclaims and credits associated with the program, and we gave up all rights to the intellectual property.
Additionally, as part of the agreement, Vertex assumed all claims, counterclaims and credits associated with the program, and we gave up all rights to the intellectual property. The transfer of the IPR&D asset to Vertex was completed in November 2023.
Personnel-related costs include salaries, benefits, and stock-based compensation for our personnel in executive, legal, finance and accounting, human resources, and other administrative functions. We expect that our general and administrative expenses will increase substantially in absolute dollars for the foreseeable future as we continue to increase our headcount to support our business growth.
Personnel-related costs include salaries, benefits, and stock-based compensation for our personnel in executive, legal, finance and accounting, human resources, and other administrative functions.
The increase of $6.8 million was primarily due to (i) $2.3 million of higher consulting, audit and accounting-related fees, and $0.9 million higher legal fees, mainly attributable to costs associated with becoming a public company and ongoing operations as a public company following our IPO in October 2024, (ii) $2.4 million of higher employee-related costs as a result of increased headcount to support our growing operations, (iii) $0.5 million of higher facility-related and office costs as we expanded our office space to accommodate higher occupancy and larger operational activities, and (iv) $0.4 million increase in corporate development expenses primarily attributable to higher public and investor relations costs associated with our transition to and operations as a public company following our IPO.
The increase of $12.6 million was primarily due to (i) $6.1 million of higher employee-related costs as a result of increased headcount to support our growing operations, (ii) $2.5 million of higher legal fees, (iii) $2.0 million of higher IT operation expenses, and (iv) $2.0 million of higher facility costs, consulting and other expenses, primarily attributable to our operational growth and operating as a public company.
As of December 31 2024, we had $420.8 million in cash, cash equivalents, and marketable securities, which we believe will be sufficient to fund our operations and capital expenditure requirements into early 2028.
In August 2025, we received a $12.5 million milestone payment from the Vertex Asset Purchase Agreement. As of December 31, 2025, we had $548.7 million in cash, cash equivalents, and marketable securities, which we believe will be sufficient to fund our operations and capital expenditure requirements at least into 2029.
Revenue Recognition We generated revenue for the years ended December 31, 2024 and 2023 from service revenue for research activities performed related to an agreement with Vertex.
All of our revenue for the year ended December 31, 2024 was generated from research activities performed for Vertex in connection with the Vertex service agreement.
Net Cash Provided by Financing Activities Net cash provided by financing activities was $377.8 million for the year ended December 31, 2024.
Net Cash Provided by Financing Activities Net cash provided by financing activities was $1.7 million for the year ended December 31, 2025 was primarily attributable to the proceeds from the exercise of stock options and employee stock purchase plan. Net cash provided by financing activities was $377.8 million for the year ended December 31, 2024.
Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical studies. 112 Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements.
Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical studies.
Expected Dividend — We have never paid dividends on our common stock and have no plans to pay dividends on our common stock. Therefore, we used an expected dividend yield of zero. We recorded stock-based compensation of $3.2 million and $1.6 million for the years ended December 31, 2024 and 2023, respectively.
Expected Dividend — We have never paid dividends on our common stock and have no plans to pay dividends on our common stock. Therefore, we used an expected dividend yield of zero. Research and Development Costs Research and development costs are expensed as incurred.
Our net losses may fluctuate significantly from period to period, depending on the timing and expenditures of our operational activities. We historically financed our operations primarily through the issuances of convertible promissory notes and convertible preferred stock, and most recently, through an IPO.
We historically financed our operations primarily through the issuances of convertible promissory notes and convertible preferred stock, an IPO, and strategic collaborations with other companies.
We recognize revenue as specified research services are performed and the results of the research and development services are provided to the customer. 106 Operating Expenses Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses. Research and Development Research and development expenses account for the largest component of our total operating expenses.
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. Operating Expenses Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses. Research and Development Research and development expenses account for the largest component of our total operating expenses.
Cash Flows The following table summarizes our cash flows for the periods indicated (in thousands): Years Ended December 31, 2024 2023 Net cash used in operating activities $ (67,470 ) $ (38,723 ) Net cash (used in) provided by investing activities (160,598 ) 22,122 Net cash provided by financing activities 377,781 74,520 Net increase in cash, cash equivalents and restricted cash $ 149,713 $ 57,919 Net Cash Used in Operating Activities Net cash used in operating activities was $67.5 million for the years ended December 31, 2024.
We do not have any off-balance sheet arrangements other than our indemnification agreements as described in Note 7 to our audited financial statements included elsewhere in this Annual Report. 109 Cash Flows The following table summarizes our cash flows for the periods indicated (in thousands): Years Ended December 31, 2025 2024 Net cash provided by (used in) operating activities $ 110,189 $ (67,470 ) Net cash used in investing activities (229,352 ) (160,598 ) Net cash provided by financing activities 1,689 377,781 Net (decrease) increase in cash, cash equivalents and restricted cash $ (117,474 ) $ 149,713 Net Cash Provided by (Used in) Operating Activities Net cash provided by operating activities was $110.2 million for the years ended December 31, 2025.
A contract’s transaction price is allocated to each distinct performance obligation on a relative standalone selling price basis and recognized as revenue when, or as, control of the distinct good or service is transferred.
Contracts that contain multiple performance obligations require an allocation of the transaction price to each performance obligation on a relative standalone selling price basis unless the transaction price is variable and meets the criteria to be allocated entirely to a performance obligation or to a distinct service that forms part of a single performance obligation.
Our net losses may fluctuate significantly from period to period, depending upon the timing of our expenditures on research and development activities.
We have incurred net losses in each year since inception, except for the year ended December 31, 2023. We expect to continue to incur net losses for the foreseeable future. Our net losses may fluctuate significantly from period to period, depending on the timing and expenditures of our operational activities.
At the same time in September 2023, we entered into a research service agreement with Vertex under which we agreed to perform certain exploratory research activities for Vertex. See the subsection titled “— Service Agreement” below. The Vertex purchase agreement also provides for a potential milestone payment payable to us contingent upon achievement of a certain research milestone.
The Vertex Asset Purchase Agreement also provided for a potential milestone payment payable to us contingent upon achievement of a certain research milestone.
In October 2024, the we completed our IPO which resulted in net proceeds of $302.8 million, after deducting underwriting discounts, commissions and offering expenses payable by us of $28.4 million.
We historically financed our operations primarily through the issuances of convertible promissory notes and convertible preferred stock, through an IPO, and strategic collaborations with other companies. In October 2024, we completed our IPO, which resulted in net proceeds of $302.8 million, net of total offering costs of $28.4 million.
Stock-Based Compensation Stock-based compensation is measured based on the estimated grant date fair value of the award and is recognized as expense on a straight-line basis over the requisite service period (usually the vesting period).
(vi) Commercial milestone payments and royalties - For arrangements that include sales-based royalties, including milestone payments based on levels of sales, if the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied) 113 Stock-Based Compensation Stock-based compensation is measured based on the estimated grant date fair value of the award and is recognized as expense on a straight-line basis over the requisite service period (usually the vesting period).
The transfer of the IPR&D asset to Vertex was completed in November 2023 and we recognized $47.6 million of gain on sale of non-financial asset for the year ended December 31, 2023 in our result of operations.
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 total operating expenses in our statement of operations and comprehensive loss for the year ended December 31, 2025.
We expect to continue to incur increased research and development expenses as we advance next-generation oral small molecule PTH1R agonists from our PTH1R program toward clinical development, advance SEP-631 into clinical development, and continue to advance other programs in our pipeline.
This was partially offset by a decrease of (i) $11.8 million in unallocated external research and development costs and (ii) $1.4 million in unallocated other costs. We expect to continue to incur increased research and development expenses as we advance SEP-631, SEP-479, and our other programs in our pipeline.
We believe our cash, cash equivalents, and marketable securities of $420.8 million as of December 31, 2024 will be sufficient to fund our operations and capital expenditure requirements into early 2028. We use contract research and development organizations to conduct our preclinical works and clinical trials.
In August 2025, we received a $12.5 million milestone payment from Vertex Pharmaceuticals Incorporated (“Vertex”) (see “Vertex Asset Purchase Agreement”). We believe our cash, cash equivalents, and marketable securities of $548.7 million as of December 31, 2025 will be sufficient to fund our operations and capital expenditure requirements at least into 2029.
Financial Overview We were incorporated in Delaware in December 2019 under the name GPCR NewCo, Inc. In June 2021, we changed our name to Septerna, Inc. We are headquartered in South San Francisco, California.
In June 2021, we changed our name to Septerna, Inc. We are headquartered in South San Francisco, California. We have incurred significant operating losses since our inception, except for the year ended December 31, 2023. Our revenue to date has been generated solely from research services.
The 105 aggregate net proceeds received by us from the IPO was $302.8 million, after deducting underwriting discounts and commissions, and other offering costs of $28.4 million.
The aggregate net proceeds received by us from the IPO was $302.8 million, net of total offering costs of $28.4 million. In July 2025, upon the effectiveness of our Novo Collaboration Agreement, we received a one-time, non-refundable upfront payment of $195.0 million (see “Novo Collaboration Agreement”).
Removed
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.
Added
We use contract research and development organizations to conduct our preclinical works and clinical trials. Additionally, we utilize third-party contract manufacturing organizations (“CMOs”), to manufacture and supply our preclinical and clinical materials during the development of our product candidates.
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Our revenue to date has been generated solely from 104 research services.
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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.
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Since our inception, we have devoted substantially all of our resources to raising capital, organizing and staffing our company, business and scientific planning, conducting discovery and research and development activities, establishing and protecting our intellectual property portfolio, developing and progressing our product candidates and preparing for clinical trials, establishing arrangements with third parties for the manufacture of our product candidates and component materials, engaging in collaboration activities, and providing general and administrative support for these operations.
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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.
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The milestone payment amount is determined based on the timing of achievement of the research milestone. The variable consideration related to this milestone payment was determined to be improbable of receipt at this time. As a result, the milestone payment was excluded from the transaction price.
Added
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.
Removed
The Vertex 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.
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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. Collaboration, Research Services, and Asset Purchase Agreements Novo Collaboration Agreement In May 2025, we entered into the Collaboration Agreement with Novo.
Removed
Food and Drug Administration (the “FDA”), European Medicines Agency (“EMA”), or any other comparable foreign regulatory authorities; • the number of trials required for regulatory approval; • the timing, receipt and terms of any regulatory approvals from applicable regulatory authorities; • our ability to establish collaboration arrangements; • the performance of any future collaborators; • establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; • significant and changing government regulation and regulatory guidance; • the impact of any business interruptions to our operations or to those of the third parties with whom we work; • obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights; • launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; and • maintaining a continued acceptable safety profile of the product candidates following approval.
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Under the Novo Collaboration Agreement, we and Novo are exclusively collaborating to leverage our proprietary Native Complex Platform® to discover, develop and commercialize multiple potential oral small molecule therapies for metabolic-related diseases based on certain specified molecular targets.
Removed
We also anticipate that we will incur increased expenses as a result of our operating as a public company, including expenses related to compliance with the rules and regulations of the SEC and expenses related to audit, legal, regulatory services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums and investor relations costs. 108 Other Income, Net Interest Income Interest income consists of interest earned on our cash, cash equivalents and marketable securities during the period.
Added
The collaboration objective is to discover and develop several novel mono-, dual-, or triple-acting oral small molecule drug candidates directed across five Collaboration Targets. The collaboration includes our most advanced preclinical metabolic program focused on developing an oral small molecule agonist to the GIP receptor.
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Results of Operations The following table sets forth our results of operations for the years ended December 31, 2024 and 2023: Years Ended December 31, 2024 2023 Change Revenue $ 1,075 $ 151 $ 924 Operating expenses (income): Research and development 65,337 35,979 29,358 General and administrative 16,561 9,722 6,839 Gain on sale of non-financial asset — (47,625 ) 47,625 Total operating expenses (income) 81,898 (1,924 ) 83,822 (Loss) income from operations (80,823 ) 2,075 (82,898 ) Other income, net: Interest income 8,617 2,786 5,831 Other (expense) income, net (90 ) 10 (100 ) Total other income, net 8,527 2,796 5,731 (Loss) income before provision for income taxes (72,296 ) 4,871 (77,167 ) (Benefit) provision for income taxes (498 ) 691 1,189 Net (loss) income $ (71,798 ) $ 4,180 $ (75,978 ) Revenue Our service revenue of $1.1 million and $0.2 million for the year ended December 31, 2024 and 2023, respectively, was generated from research activities performed for Vertex in connection with the Vertex service agreement. 109 Operating Expenses (Income) Research and Development The following table summarizes our research and development expenses for the periods indicated by direct and unallocated costs (in thousands): Years Ended December 31, 2024 2023 Change Direct costs: PTH1R $ 11,719 $ 4,334 $ 7,385 MRGPRX2 2,866 1,981 885 Other programs 4,222 3,478 744 Unallocated costs: Payroll-related costs 17,924 12,490 5,434 External research and development costs 15,287 5,313 9,974 Facility-related and office costs 6,390 3,181 3,209 Other costs 6,929 5,202 1,727 Total research and development expense $ 65,337 $ 35,979 $ 29,358 Research and development expense was $65.3 million and $36.0 million for the years ended December 31, 2024 and 2023, respectively.
Added
We and Novo have initially commenced four simultaneous research and development programs (each an “R&D Program”) with each pursuing one or more Collaboration Targets from discovery through development candidate selection.
Removed
The SEP-786 clinical study was discontinued in February 2025 and we do not anticipate incurring significant additional clinical trial costs associated with that study.
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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 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.
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Other Income, Net Interest Income Interest income was $8.6 million and $2.8 million for the years ended December 31, 2024 and 2023, respectively.
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