[8-K] Septerna, Inc. Reports Material Event
Rhea-AI Filing Summary
Septerna, Inc. reported strong fourth quarter and full year 2025 results alongside major pipeline progress. Revenue rose to $24.1 million in the fourth quarter of 2025 and $46.0 million for the full year, up sharply from $0.2 million and $1.1 million in 2024, primarily reflecting collaboration work and amortization of a Novo Nordisk upfront payment.
The company recorded a net loss of $10.7 million for the quarter and $48.9 million for 2025, narrowing from $20.7 million and $71.8 million in 2024, as higher revenue partially offset increased R&D and G&A expenses. Cash, cash equivalents, and marketable securities were $548.7 million as of December 31, 2025, and the cash runway is expected to fund operations at least into 2029.
Clinically, Septerna reported compelling Phase 1 data for SEP-631 in mast cell diseases, supporting Phase 2b development in chronic spontaneous urticaria in the second half of 2026, and is advancing SEP-479 toward a Phase 1 trial in the first half of 2026, while continuing progress on its TSHR NAM and discovery programs.
Positive
- None.
Negative
- None.
Insights
Collaboration-driven revenue surge, narrowed losses, and deep cash runway support an advancing pipeline.
Septerna showed a major shift in its financial profile in 2025. Revenue increased to
Despite this investment, annual net loss improved to
On the pipeline side, positive Phase 1 data for SEP-631 in mast cell diseases, with complete wheal inhibition at certain doses, supports a planned Phase 2b chronic spontaneous urticaria trial in the second half of
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On March 9, 2026, Septerna, Inc. (the “Company”) announced its financial results and business highlights for the fourth quarter and year ended December 31, 2025. A copy of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information included under Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 |
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Press Release issued by Septerna, Inc. dated March 9, 2026, furnished herewith. |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Septerna, Inc. |
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March 9, 2026 |
By: |
/s/ Jeffrey Finer, M.D., Ph.D. |
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Jeffrey Finer, M.D., Ph.D. |
Exhibit 99.1
Septerna Highlights Pipeline Progress and Reports Fourth Quarter and Full Year 2025 Financial Results
Compelling Phase 1 Data for SEP-631 (MRGPRX2 NAM) in Healthy Volunteers Support Phase 2b Development, Initially in Chronic Spontaneous Urticaria (CSU) in Second Half of 2026
Advancing SEP-479 (PTH1R Agonist) Toward Phase 1 Initiation in First Half of 2026
Cash Runway Expected to Support Operating Plans at Least into 2029
SOUTH SAN FRANCISCO, Calif. – March 9, 2026 – Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted pipeline progress and anticipated milestones and reported financial results for the fourth quarter and full year ended December 31, 2025.
"We made significant strides advancing our pipeline in the past year, and 2026 has already delivered a meaningful milestone with positive Phase 1 results for SEP-631,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “These results demonstrate clinical proof-of-mechanism and validate the ability of our Native Complex Platform® to uncover novel mechanisms of action and rapidly generate differentiated oral small molecules for historically challenging GPCRs. With SEP-479 approaching Phase 1 initiation in the coming months, SEP-631 poised for Phase 2 development in the second half of the year, and additional programs progressing behind them, we believe 2026 will be a year of strong progress for Septerna and for the patients we are committed to serving.”
Recent Pipeline Progress and Anticipated Milestones
Business Highlights
Fourth Quarter and Full Year 2025 Financial Results
About Septerna
Septerna, Inc. is a clinical-stage biotechnology company with a world-class team of GPCR experts and drug developers advancing cutting-edge science to unlock the full potential of GPCR therapies for patients with significant unmet needs. The company’s 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. Septerna is advancing programs in endocrinology, immunology and inflammation, metabolic diseases and additional therapeutic areas, both independently and with partners. For more information, please visit www.septerna.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Septerna’s beliefs and expectations regarding: the continued advancement of SEP-631, including the plan to initiate a Phase 2b clinical study in CSU in the second half of 2026 subject to the successful completion of long-term preclinical toxicology studies; the role of MRGPRX2 in mast cell-driven diseases; the potential of SEP-631 to provide a convenient oral treatment option for patients with CSU and other mast cell-driven diseases; expectations regarding the anticipated once-daily dosing frequency of SEP-631; the ability of the SEP-631 Phase 1 safety and efficacy observations to successfully translate into clinical outcomes in patients; the continued advancement of SEP-479, including the plan to initiate a Phase 1 clinical study in the first half of 2026; the continued development of its TSHR NAM program; the advancement of its discovery-stage programs across multiple therapeutic areas; the potential of its proprietary Native Complex Platform®; the size and growth potential of the markets for its current and future product candidates; its expectations regarding strategic plans for its business, product candidates, and technology; its expectations regarding the company’s uses of capital, expenses and financial results, including its expected cash runway at least into 2029; and the scope of protection it is able to establish and maintain for intellectual property rights covering its
Native Complex Platform® and its product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: Septerna’s product candidates successfully entering and advancing through clinical trials (including those for SEP-631) including uncertainties related to opening INDs and obtaining other regulatory approvals; risks related to clinical development outcomes including unexpected safety or efficacy findings; the results of preclinical studies including the long-term toxicology studies for SEP-631, or clinical studies not being predictive of future clinical outcomes; risks related to the timing of initiating clinical studies and future availability of clinical data; the scope of protection Septerna is able to establish and maintain for intellectual property rights covering its Native Complex Platform® and its product candidates; and Septerna’s ability to identify and enter into future license agreements and collaborations; and general economic, industry and market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Septerna’s Annual Report on Form 10-K for the year ended December 31, 2025, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Septerna’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Septerna explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor Contact:
Renee Leck, THRUST
renee@thrustsc.com
Media Contact:
Carly Scaduto, THRUST
carly@thrustsc.com
SEPTERNA, INC.
Condensed Statements of Operations
(In thousands, except for share and per share data)
(Unaudited)
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Three Months Ended |
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Years Ended December 31, |
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2025 |
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2024 |
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2025 |
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2024 |
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Revenue |
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$ |
24,118 |
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$ |
212 |
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$ |
45,951 |
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$ |
1,075 |
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Operating expenses: |
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Research and development |
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31,861 |
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19,317 |
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97,584 |
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65,337 |
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General and administrative |
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8,280 |
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5,613 |
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29,164 |
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16,561 |
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Gain on sale of non-financial asset |
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— |
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— |
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(12,500 |
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— |
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Total operating expenses |
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40,141 |
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24,930 |
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114,248 |
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81,898 |
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Loss from operations |
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(16,023 |
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(24,718 |
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(68,297 |
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(80,823 |
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Interest income and other expense, net |
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5,297 |
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3,890 |
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19,430 |
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8,527 |
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Provision (benefit) for income taxes |
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12 |
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(160 |
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12 |
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(498 |
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Net loss |
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$ |
(10,738 |
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$ |
(20,668 |
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$ |
(48,879 |
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$ |
(71,798 |
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Net loss per share, basic and diluted |
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$ |
(0.24 |
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$ |
(0.64 |
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$ |
(1.10 |
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$ |
(7.26 |
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Weighted-average shares outstanding, basic and diluted |
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44,579,697 |
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32,383,314 |
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44,258,338 |
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9,891,126 |
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Condensed Balance Sheets
(In thousands)
(Unaudited)
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December 31, |
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September 30, |
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December 31, |
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2025 |
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2025 |
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2024 |
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Cash, cash equivalents and marketable securities |
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$ |
548,658 |
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$ |
561,558 |
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$ |
420,789 |
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Working capital (1) |
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324,033 |
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416,399 |
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343,975 |
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Total assets |
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596,187 |
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606,653 |
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456,554 |
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Total liabilities |
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214,261 |
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217,922 |
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36,507 |
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Additional paid-in capital |
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548,517 |
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544,826 |
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538,321 |
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Accumulated deficit |
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(167,253 |
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(156,515 |
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(118,374 |
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Total stockholders' equity |
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$ |
381,926 |
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$ |
388,731 |
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$ |
420,047 |
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Filing Exhibits & Attachments
2 documentsPress Releases
