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]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

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]

Financial Performance - The company recorded a net income of $4.2 million for the year ended December 31, 2023, primarily due to a gain of $47.6 million from the sale of an in-progress research and development asset [102][103]. - The company incurred net losses of $20.5 million and $51.1 million for the three and nine months ended September 30, 2024, respectively, compared to net losses of $10.9 million and $30.7 million for the same periods in 2023 [103]. - The net loss for the three months ended September 30, 2024, was $20.5 million, compared to a net loss of $10.9 million in 2023, indicating a worsening financial position [130]. - The company reported net losses of $20.5 million and $51.1 million for the three and nine months ended September 30, 2024, respectively, compared to net losses of $10.9 million and $30.7 million for the same periods in 2023 [144]. - The company expects to continue incurring net losses for the foreseeable future, with an accumulated deficit of $97.7 million as of September 30, 2024 [144]. Revenue Generation - The company has not generated any revenue from product sales and relies solely on research services for revenue generation [116]. - Revenue for the three months ended September 30, 2024, was $176,000, a significant increase of 433% compared to $33,000 for the same period in 2023 [130]. - For the nine months ended September 30, 2024, total revenue was $863,000, an increase of 2515% from $33,000 in the same period of 2023 [137]. - Service revenue from research activities for Vertex was $0.2 million for the three months ended September 30, 2024, compared to negligible revenue in the same period of 2023 [131]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $17.8 million, up 92% from $9.3 million in 2023, primarily due to increased external research costs and higher direct costs [132]. - Total operating expenses for the nine months ended September 30, 2024, were $56.9 million, up 77% from $32.3 million in 2023, largely due to increased research and development costs [137]. - Research and development expenses increased to $46.0 million for the nine months ended September 30, 2024, up from $25.7 million in the same period of 2023, representing a change of $20.4 million [139]. - General and administrative expenses increased to $4.9 million for the three months ended September 30, 2024, from $2.8 million in 2023, reflecting higher consulting and employee-related costs [134]. - General and administrative expenses rose to $10.9 million for the nine months ended September 30, 2024, compared to $6.6 million in 2023, an increase of $4.3 million [140]. Cash and Funding - The company has cash, cash equivalents, and marketable securities of $137.5 million, which, along with IPO proceeds, is expected to fund operations into the second half of 2027 [109]. - Net cash used in operating activities was $46.5 million for the nine months ended September 30, 2024, compared to $29.9 million in 2023 [148]. - The company completed its IPO in October 2024, raising approximately $302.6 million in net proceeds after deducting offering costs [107]. - Future funding requirements will depend on various factors, including the progress of clinical trials and potential collaborations [154]. Research and Development - The company expects to incur significant expenses related to research and development, including costs for clinical trials and external research services [104][119]. - The company utilizes contract research organizations for preclinical and clinical trials and plans to continue this approach until internal manufacturing capabilities are justified [110]. - The increase in research and development expenses was attributed to $3.4 million in external research costs and $3.0 million in higher direct costs for preclinical programs [132]. - The company aims to expand its pipeline of product candidates across multiple therapeutic areas, including endocrinology, immunology, and metabolic diseases [97]. Accounting and Compliance - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of new accounting standards until they apply to private companies [167]. - The company may remain an emerging growth company until it exceeds $1.235 billion in annual gross revenue or meets other specified criteria [167]. - The market value of the company's stock held by non-affiliates must be less than $250 million or annual revenue must be less than $100 million to qualify as a "smaller reporting company" [167]. - There were no material changes to the company's critical accounting policies and estimates during the nine months ended September 30, 2024 [165]. - The company is not required to provide quantitative and qualitative disclosures about market risk as it is classified as a smaller reporting company [168]. - Recent accounting pronouncements that may impact the company's financial position are disclosed in the quarterly report [166]. - The financial statements may not be comparable to those of companies that comply with new accounting pronouncements as of public company effective dates [167]. - The company has elected to use the extended transition period under the JOBS Act until it no longer qualifies as an emerging growth company [167]. - The preparation of financial statements requires estimates and assumptions that affect reported amounts of assets and liabilities [164]. - Actual results may differ from estimates, which could be material to the company's financial condition [164].

Exhibit 99.1 Septerna Reports Third Quarter 2024 Financial Results and Recent Business Highlights Deep Pipeline of GPCR Programs Focused Initially on Indications in Endocrinology, Immunology and Inflammation, and Metabolic Diseases Phase 1 Clinical Trial Ongoing for SEP-786, Oral Small Molecule for Hypoparathyroidism, with Data Expected in Mid-2025 Well-Capitalized with Balance Sheet to Support a Planned Operating Runway into Second Half of 2027 SOUTH SAN FRANCISCO, Calif. – November 20, 2024 – Septerna, In ...

Deep Pipeline of GPCR Programs Focused Initially on Indications in Endocrinology, Immunology and Inflammation, and Metabolic Diseases Phase 1 Clinical Trial Ongoing for SEP-786, Oral Small Molecule for Hypoparathyroidism, with Data Expected in Mid-2025 Well-Capitalized with Balance Sheet to Support a Planned Operating Runway into Second Half of 2027 SOUTH SAN FRANCISCO, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G p ...