Financial Performance - Septerna reported a net loss of $20.7 million for Q4 2024, compared to a net income of $34.9 million in Q4 2023[10]. - Revenue for Q4 2024 was $212,000, a significant increase from $118,000 in Q4 2023, while total revenue for the full year 2024 was $1.075 million, compared to $151,000 in 2023[17]. - Septerna's total assets were reported at $456.6 million as of December 31, 2024, with total liabilities of $36.5 million[19]. Research and Development - Research and development (R&D) expenses increased to $19.3 million in Q4 2024 from $10.3 million in Q4 2023, and total R&D expenses for the full year 2024 were $65.3 million, up from $36.0 million in 2023[10]. - Septerna plans to select a next-generation oral small molecule PTH1R agonist candidate by the end of 2025 to advance toward clinical development[3]. - The Phase 1 trial for SEP-631, a selective MRGPRX2 NAM for mast cell diseases, is expected to initiate in 2025[4]. - Septerna discontinued its Phase 1 clinical trial of SEP-786 in February 2025 due to elevated bilirubin levels observed during the trial[3]. - The company continues to progress several TSHR NAM lead compounds for Graves' disease and thyroid eye disease[5]. Cash and Liquidity - Cash, cash equivalents, and marketable securities totaled $420.8 million as of December 31, 2024, providing a runway into early 2028[10]. General and Administrative Expenses - General and administrative (G&A) expenses rose to $5.6 million in Q4 2024 from $3.1 million in Q4 2023, with total G&A expenses for the full year 2024 at $16.6 million, up from $9.7 million in 2023[10].

Preclinical Work Advancing with Plans to Select a Next-Generation Oral Small Molecule PTH1R Agonist to Accelerate Toward the Clinic Later This Year Phase 1 Trial for SEP-631, MRGPRX2 NAM Program for Mast Cell Diseases, Expected to Initiate in 2025 Well-Capitalized with $420.8M Balance Sheet as of YE 2024 to Support Operating Runway into Early 2028 SOUTH SAN FRANCISCO, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a biotechnology company pioneering a new era of G protein-coupled r ...

Core Viewpoint - The Schall Law Firm is investigating claims against Septerna, Inc. for potential violations of securities laws related to misleading statements and failure to disclose critical information to investors [1][2]. Group 1: Investigation Details - The investigation centers on whether Septerna issued false or misleading statements and failed to disclose relevant information to investors [2]. - On February 18, 2025, Septerna announced the discontinuation of its Phase 1 clinical trial for SEP-786 due to two severe adverse events related to elevated unconjugated bilirubin [2]. - Following this announcement, Septerna's shares experienced a significant decline of 46.99% on the same day [2]. Group 2: Legal Representation - The Schall Law Firm is representing investors globally and specializes in securities class action lawsuits and shareholder rights litigation [3]. - Shareholders who suffered losses are encouraged to contact the firm for a free discussion of their rights [3].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Septerna, Inc and its officers or directors [1] Group 1: Company Overview - Septerna, Inc conducted its initial public offering (IPO) on October 25, 2024, offering 18.4 million shares at a price of $18.00 per share [2] - On February 18, 2025, Septerna announced the discontinuation of its Phase 1 clinical trial for SEP-786 due to two severe adverse events related to elevated unconjugated bilirubin [3] Group 2: Market Reaction - Following the announcement of the trial discontinuation, Septerna's stock price dropped by $6.09, representing a decline of 46.99%, closing at $6.87 per share on the same day [3]

Company Overview - Septerna, Inc. is a biotechnology company focused on G protein-coupled receptor (GPCR) drug discovery using its proprietary Native Complex Platform™ [2] - The company aims to unlock the full potential of GPCR therapies and has developed a deep pipeline of oral small molecule product candidates [2] - Initial therapeutic areas of focus include endocrinology, immunology and inflammation, and metabolic diseases [2] Upcoming Events - Jeffrey Finer, M.D., Ph.D., CEO and Co-founder of Septerna, will present at the TD Cowen 45 Annual Health Care Conference on March 5, 2025, at 10:30 a.m. ET in Boston [1]

Core Insights - Kirby McInerney LLP is investigating potential claims against Septerna, Inc. regarding possible violations of federal securities laws and unlawful business practices [1][3] - On February 18, 2025, Septerna announced the discontinuation of its Phase 1 clinical trial for SEP-786 due to two severe cases of elevated unconjugated bilirubin, leading to a significant drop in share price [3] Company Developments - Septerna decided to halt the Phase 1 single- and multiple-ascending dose clinical trial of SEP-786, an oral small molecule PTH1R agonist for hypoparathyroidism treatment [3] - The decision was prompted by the observation of two unexpected severe (Grade 3) cases of elevated unconjugated bilirubin without corresponding increases in liver enzyme levels [3] - Following the announcement, Septerna's share price fell by $6.09, approximately 46%, from $12.96 on February 14, 2025, to $6.87 on February 18, 2025 [3]

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Core Insights - Septerna, Inc. has decided to discontinue the Phase 1 clinical trial of SEP-786 due to unanticipated severe events of elevated unconjugated bilirubin levels observed in participants [1][2][3] - The company is committed to advancing its PTH1R agonist program with multiple next-generation candidates that have distinct chemical structures [1][3] Group 1: Clinical Trial and Observations - The Phase 1 trial of SEP-786 was halted after two participants experienced Grade 3 elevations in unconjugated bilirubin, although no liver enzyme elevations were noted [2] - Dosing was stopped for the affected participants, and the bilirubin elevations were reversible, with no serious adverse events reported in the trial [2] Group 2: Future Plans and Financial Position - Septerna plans to select a next-generation PTH1R agonist candidate to accelerate clinical development later this year, despite the discontinuation of SEP-786 [3][4] - The company reported a cash position of $137.5 million as of September 30, 2024, along with $302.6 million in net proceeds from its IPO in October 2024, which is expected to support operations into at least the second half of 2027 [4]

Core Insights - Septerna, Inc. has appointed Gil Labrucherie as Chief Financial Officer, bringing over 25 years of experience in finance and legal roles within the biopharmaceutical and technology sectors [1][2] - The company is focused on advancing its pipeline of oral small molecule GPCR programs, particularly SEP-786, and expanding its Native Complex Platform for drug discovery [2][4] Company Overview - Septerna, Inc. is a clinical-stage biotechnology company specializing in G protein-coupled receptor (GPCR) drug discovery, utilizing its proprietary Native Complex Platform [4] - The company aims to develop therapies targeting endocrinology, immunology and inflammation, and metabolic diseases [4] Leadership Background - Gil Labrucherie previously served as CFO and CBO at ACELYRIN, overseeing finance, investor relations, and business development [2] - He has raised over $1.5 billion in private and public equity capital and generated more than $1 billion in value from strategic partnerships throughout his career [2]

Company Overview - Septerna is a clinical-stage biotechnology company focused on GPCR-targeted drug discovery using its proprietary Native Complex Platform [3] - The company aims to unlock the full potential of GPCR therapies and has developed a pipeline of oral small molecule product candidates [3] - Initial therapeutic areas of focus include endocrinology, immunology and inflammation, and metabolic diseases [3] Upcoming Presentation - Jeffrey Finer, M.D., Ph.D., CEO and co-founder of Septerna, will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025, at 3:45 p.m. PT [1] - A live webcast of the presentation will be available on the company's website and archived for 30 days [2]