SEPN 8-K
Septerna, Inc. (SEPN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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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:
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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 November 10, 2025, Septerna, Inc. (the “Company”) announced its financial results and business highlights for the quarter ended September 30, 2025. A copy of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report of 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. on November 10, 2025, 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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Date: |
November 10, 2025 |
By: |
/s/ Jeffrey Finer, M.D., Ph.D. |
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Jeffrey Finer, M.D., Ph.D. |
Exhibit 99.1
Septerna Highlights Company Progress and Reports Third Quarter 2025 Financial Results
SEP-479 Selected as Next-Generation Oral PTH1R Agonist Development Candidate
SEP-631 (MRGPRX2 NAM) Phase 1 Clinical Trial in Healthy Volunteers Ongoing
Robust Financial Position of $561.6 million Expected to Support Operations at Least into 2029
SOUTH SAN FRANCISCO, Calif. – November 10, 2025 – Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted key business updates and upcoming milestones and reported financial results for the quarter ended September 30, 2025.
“In the third quarter, we made meaningful progress across our portfolio, highlighted by the selection of SEP-479 as our next-generation PTH1R agonist development candidate for hypoparathyroidism and the initiation of our Phase 1 clinical trial for SEP-631 which targets MRGPRX2 for mast cell-driven diseases,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “Both programs exemplify the power of our Native Complex Platform™ to generate differentiated oral small-molecule GPCR therapies with the potential to address serious diseases across a range of indications. With multiple milestones anticipated in the first half of 2026, we are executing with focus and momentum as we work to deliver meaningful therapies for patients.”
Corporate Overview and Anticipated Milestones
Business Highlights
Third Quarter 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 Septerna’s PTH1R agonist program, including the planned initiation of a Phase 1 clinical trial for SEP-479 in the first half of 2026, subject to successful completion of preclinical activities and regulatory submissions; the continued development and advancement of SEP-631, including the ongoing Phase 1 clinical trial and the timing of initial data expected in the first half of 2026 for the Phase 1 single-ascending-dose and multiple-ascending-dose cohorts; its ability to demonstrate, and the timing of, preclinical proof-of-concept in vivo and ex vivo for multiple programs; its ability to advance any product candidates that it may identify and successfully complete any clinical studies; the initiation, timing, progress, and results of conducting its research and development programs, including its plans to advance multiple lead TSHR NAM program compounds toward development candidate selection; the potential of its proprietary Native Complex Platform™; the collaboration with Novo Nordisk, including its to jointly discover, develop and commercialize multiple potential oral small molecule therapies for obesity, type 2 diabetes, and other cardiometabolic diseases; its expectations regarding the implementation of its business model, strategic plans for its business, product candidates, and technology; and the accuracy of its estimates regarding expenses and capital requirements, including its expected cash runway at least into 2029. 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 SEP-479 and SEP-631); the authorization, initiation, and successful completion of preclinical and Investigational New Drug (IND)-enabling studies to support future clinical development of potential product candidates (including those for SEP-479), including uncertainties related to opening INDs and other regulatory approvals; risks related to clinical development outcomes including unexpected safety or efficacy findings; the results of preclinical studies, 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; Septerna’s ability to maintain existing collaborations, identify and enter into future license agreements and collaborations, and realize the intended and potential benefits thereof; unanticipated future expense levels and capital requirements; 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, 2024, 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
Media Contact:
Carly Scaduto
SEPTERNA, INC.
Condensed Statements of Operations
(In thousands, except for share and per share data)
(Unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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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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$ |
21,495 |
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$ |
176 |
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$ |
21,833 |
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$ |
863 |
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Operating expenses: |
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Research and development |
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24,264 |
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17,832 |
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65,723 |
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46,020 |
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General and administrative |
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7,117 |
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4,894 |
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20,884 |
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10,948 |
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Gain on sale of non-financial asset |
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(12,500 |
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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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18,881 |
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22,726 |
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74,107 |
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56,968 |
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Income (loss) from operations |
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2,614 |
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(22,550 |
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(52,274 |
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(56,105 |
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Interest and other income, net |
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5,559 |
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1,891 |
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14,133 |
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4,637 |
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Benefit for income taxes |
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— |
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136 |
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— |
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338 |
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Net income (loss) attributable to common stockholders |
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$ |
8,173 |
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$ |
(20,523 |
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$ |
(38,141 |
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$ |
(51,130 |
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Net income (loss) per share attributable to common stockholders, basic |
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$ |
0.18 |
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$ |
(8.40 |
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$ |
(0.86 |
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$ |
(21.87 |
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Net income (loss) per share attributable to common stockholders, diluted |
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$ |
0.18 |
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$ |
(8.40 |
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$ |
(0.86 |
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$ |
(21.87 |
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Weighted-average shares outstanding, basic |
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44,343,085 |
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2,443,678 |
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44,150,041 |
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2,337,891 |
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Weighted-average shares outstanding, diluted |
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45,602,099 |
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2,443,678 |
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44,150,041 |
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2,337,891 |
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Condensed Balance Sheets
(In thousands)
(Unaudited)
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September 30, |
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December 31, |
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Cash, cash equivalents and marketable securities |
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$ |
561,558 |
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$ |
420,789 |
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Working capital (1) |
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416,399 |
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343,975 |
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Total assets |
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606,653 |
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456,554 |
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Total liabilities |
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217,922 |
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36,507 |
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Additional paid-in capital |
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544,826 |
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538,321 |
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Accumulated deficit |
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(156,515 |
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(118,374 |
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Total stockholders’ equity |
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388,731 |
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420,047 |
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