Group 1 - Septerna, a San Francisco-based biotech company, completed its IPO in October 2024, raising approximately $331.2 million by issuing 18.4 million shares priced at $18 each [1] - Following the IPO, the stock of Septerna experienced an initial surge, which is a common trend among biotech stocks post-IPO [1] - The investing group Haggerston BioHealth, led by biotech consultant Edmund Ingham, provides insights into key trends and catalysts in the biotech, pharma, and healthcare industries, catering to both novice and experienced investors [1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-42382 Septerna, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 84-3891440 ( ...

[Business Highlights and Corporate Overview](index=1&type=section&id=Business%20Highlights%20and%20Corporate%20Overview) Septerna announced a landmark collaboration with Novo Nordisk, advanced its pipeline, and significantly extended its cash runway [Key Business Updates and Milestones](index=1&type=section&id=Key%20Business%20Updates%20and%20Milestones) Septerna announced a landmark collaboration with Novo Nordisk, advanced its pipeline, and significantly extended its cash runway - Announced a global collaboration with Novo Nordisk to develop oral small molecules for metabolic diseases, with potential milestone payments exceeding **$2.2 billion**[2](index=2&type=chunk) - On track to select a next-generation oral small molecule PTH1R agonist candidate to advance toward the clinic by the end of 2025[2](index=2&type=chunk)[3](index=3&type=chunk) - Expects to initiate a Phase 1 clinical trial for SEP-631, a program for mast cell diseases, in the third quarter of 2025[2](index=2&type=chunk)[3](index=3&type=chunk) - Ended Q1 2025 with **$398.2 million** in cash, cash equivalents, and marketable securities. The Novo Nordisk collaboration is expected to significantly extend the prior cash runway guidance of early 2028[2](index=2&type=chunk) [Pipeline Program Updates](index=1&type=section&id=Pipeline%20Program%20Updates) Septerna is advancing its wholly-owned pipeline, including PTH1R and SEP-631 programs, with key milestones expected in 2025 - PTH1R Agonist Program: Plans to select a next-generation candidate for hypoparathyroidism by the end of 2025, with compounds showing favorable PK profiles for potential once- or twice-daily dosing[6](index=6&type=chunk) - SEP-631 MRGPRX2 NAM Program: A Phase 1 clinical trial for this oral small molecule, targeting mast cell diseases, is anticipated to begin in Q3 2025[6](index=6&type=chunk) - TSHR NAM Program: The company is progressing several lead compounds designed as a disease-modifying treatment for Graves' disease and thyroid eye disease towards candidate selection[6](index=6&type=chunk) [Collaboration Agreement with Novo Nordisk](index=1&type=section&id=Collaboration%20Agreement%20with%20Novo%20Nordisk) Septerna announced a global collaboration with Novo Nordisk for cardiometabolic diseases, securing over **$200 million** in upfront payments and R&D funding - The collaboration will initially focus on four R&D programs for small molecule therapies directed to GPCR targets like GLP-1, GIP, and glucagon receptors[6](index=6&type=chunk) Financial Terms of the Novo Nordisk Collaboration | Term | Details | | :--- | :--- | | **Total Potential Value** | Approx. $2.2 billion in upfront, research, development, and commercial milestones | | **Upfront & Near-Term Payments** | Over $200 million | | **Royalties** | Tiered royalties on global net sales of marketed products | | **R&D Funding** | Novo Nordisk will cover all R&D expenses for partnered programs | | **Opt-in Right** | Septerna can opt-in to a worldwide profit-share for one program in lieu of milestones and royalties | [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Septerna reported a net loss of **$21.5 million** in Q1 2025, driven by increased expenses, while maintaining a strong cash position significantly bolstered by the Novo Nordisk collaboration [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) Septerna reported a **$21.5 million** net loss in Q1 2025 due to increased expenses, maintaining a strong **$398.2 million** cash position extended by the Novo Nordisk deal - Cash, cash equivalents, and marketable securities totaled **$398.2 million** as of March 31, 2025[11](index=11&type=chunk) - The upfront payment from the Novo Nordisk collaboration is expected to significantly extend the prior cash runway guidance of early 2028[11](index=11&type=chunk) Q1 2025 vs. Q1 2024 Financial Comparison (In millions) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | R&D Expenses | $19.3 | $13.2 | | G&A Expenses | $6.9 | $2.7 | | Net Loss | $21.5 | $14.2 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Septerna's Q1 2025 revenue was **$0.2 million**, resulting in a **$21.5 million** net loss, primarily due to increased operating expenses Condensed Statements of Operations (Unaudited, In thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenue | $219 | $317 | | Research and development | $19,271 | $13,153 | | General and administrative | $6,858 | $2,654 | | Total operating expenses | $26,129 | $15,807 | | Loss from operations | ($25,910) | ($15,490) | | Net loss | ($21,476) | ($14,166) | | Net loss per share, basic and diluted | ($0.49) | ($6.35) | [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, Septerna reported total assets of **$434.0 million**, with cash and equivalents at **$398.2 million**, and stockholders' equity at **$400.3 million** Condensed Balance Sheets (Unaudited, In thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $398,247 | $420,789 | | Total assets | $434,020 | $456,554 | | Total liabilities | $33,754 | $36,507 | | Total stockholders' equity | $400,266 | $420,047 | [Company Information and Forward-Looking Statements](index=2&type=section&id=Company%20Information%20and%20Forward-Looking%20Statements) Septerna is a biotechnology company focused on GPCR drug discovery, with forward-looking statements highlighting future collaborations, pipeline development, and financial projections subject to inherent risks [About Septerna](index=2&type=section&id=About%20Septerna) Septerna is a biotechnology company leveraging its Native Complex Platform™ for GPCR drug discovery, focusing on oral small molecule candidates across multiple therapeutic areas - The company's core technology is its proprietary Native Complex Platform™ for GPCR drug discovery[8](index=8&type=chunk) - Focuses on developing oral small molecule product candidates in three main therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases[8](index=8&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) Forward-looking statements cover the Novo Nordisk collaboration, pipeline development, and financial projections, subject to risks detailed in SEC filings - Forward-looking statements pertain to the Novo Nordisk collaboration, pipeline development, clinical trial timing, platform potential, and financial runway[9](index=9&type=chunk) - These statements involve significant risks and uncertainties, and actual results may differ materially from expectations[10](index=10&type=chunk) - The company directs readers to the 'Risk Factors' section of its Annual Report on Form 10-K for a more detailed description of these risks[10](index=10&type=chunk)

Core Insights - Septerna, Inc. announced a global collaboration with Novo Nordisk to develop oral small molecules for metabolic diseases, with potential milestone payments exceeding $2.2 billion [1][6] - The company is on track to select a next-generation oral small molecule PTH1R agonist for clinical advancement by the end of 2025 [1][5] - Septerna ended Q1 2025 with $398.2 million in cash, significantly extending its cash runway guidance to early 2028 due to the collaboration [1][11] Collaboration with Novo Nordisk - The partnership aims to discover, develop, and commercialize multiple oral small molecule medicines targeting obesity, type 2 diabetes, and other cardiometabolic diseases [5][6] - The collaboration includes an upfront payment and milestone payments, with over $200 million expected in the near term [6] - Novo Nordisk will cover all R&D expenses for the partnered programs, providing Septerna with operational flexibility [6] Pipeline Development - Septerna is advancing its PTH1R agonist program, with plans to select a candidate for clinical trials by the end of 2025 [5][6] - The SEP-631 program for mast cell diseases is expected to initiate a Phase 1 clinical trial in Q3 2025 [1][5] - The company is also progressing TSHR NAM lead compounds aimed at treating Graves' disease and thyroid eye disease [5] Financial Performance - For Q1 2025, Septerna reported a net loss of $21.5 million, compared to a net loss of $14.2 million in Q1 2024 [11][14] - R&D expenses increased to $19.3 million in Q1 2025 from $13.2 million in Q1 2024, while G&A expenses rose to $6.9 million from $2.7 million [11][14] - The total cash, cash equivalents, and marketable securities as of March 31, 2025, were $398.2 million, down from $420.8 million at the end of 2024 [11][16]

Core Viewpoint - Septerna (SEPN.US) experienced a significant pre-market surge of 63%, reaching $10.97 with a trading volume of $65.44 million, indicating strong investor interest in the company's developments in GPCR-targeted therapies [2]. Group 1: Company Developments - Septerna is focused on developing therapies targeting G protein-coupled receptors (GPCRs), which are crucial for the absorption of chemical substances through cell membranes [2]. - Two companies are planning to initiate four potential small molecule therapy development projects targeting specific GPCRs, marking a notable collaboration in the pharmaceutical industry [4]. - Novo Nordisk is known for its weight loss drug Wegovy and is working to solidify its position in the rapidly growing obesity treatment market, projected to reach $150 billion [6]. Group 2: Market Context - GPCRs influence a wide range of physiological processes, including metabolism, secretion, cell growth, and immune responses, highlighting their importance in therapeutic development [3]. - The recent collaboration in the obesity sector follows a significant deal in March, where Roche announced plans to invest up to $5.3 billion with Zealand Pharma to develop and commercialize its obesity candidate drug [4].

Group 1 - Shares of Septerna, Inc. (SEPN) have increased by 0.8% over the past four weeks, closing at $6.29, with a mean price target of $19.33 indicating a potential upside of 207.3% [1] - The average price targets range from a low of $11 to a high of $27, with a standard deviation of $8.02, suggesting a potential increase of 74.9% to 329.3% from the current price level [2] - Analysts show strong agreement in revising earnings estimates higher, which correlates with potential stock price movements, as the Zacks Consensus Estimate for the current year has increased by 6.7% over the past month [10][11] Group 2 - SEPN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating a strong potential upside in the near term [12] - The consensus price target, while not entirely reliable, suggests a positive direction for price movement, supported by the analysts' growing optimism regarding the company's earnings prospects [10][12]

Financial Performance - For the year ended December 31, 2024, the company reported a net loss of $71.8 million and an accumulated deficit of $118.4 million[239]. - The company has no products approved for commercial sale and has not generated any revenue from product sales to date[239]. - As of December 31, 2024, the company had $420.8 million in cash, cash equivalents, and marketable securities, expected to fund operations into early 2028[242]. - The company anticipates significant and increasing operating losses for at least the next several years due to ongoing research and development expenses[239]. - The company has a limited operating history and has incurred significant operating losses since its inception in December 2019[237]. Product Development and Clinical Trials - The company has not successfully completed any clinical trials and all current product candidates are in preclinical development or drug discovery stages[238]. - The company plans to advance SEP-631 into clinical development in 2025 and is working on multiple lead compounds for a next-generation oral small molecule PTH1R agonist[250]. - The company expects to incur substantial commercialization expenses if any product candidates receive regulatory approval[241]. - The company may require substantial additional funding to finance operations and product development, with no committed sources of additional capital[241]. - The company faces risks related to the discovery, development, and regulatory approval of product candidates, which could materially harm its business[250]. - The company may face significant delays in the development and commercialization of product candidates due to various factors, including regulatory approval issues and clinical trial challenges[251]. - High drop-out rates and delays in patient enrollment in clinical trials could adversely affect the timelines for product development[254]. - The lengthy and expensive nature of preclinical and clinical drug development poses a high risk of failure, impacting the company's financial condition and growth prospects[253]. - Regulatory authorities may impose additional requirements or delays in approving clinical trials, which could hinder the company's ability to bring products to market[256]. - The company has not yet completed any clinical trials for its product candidates, making it difficult to predict the success of future developments[258]. - Serious adverse events or unexpected side effects identified during development could lead to the discontinuation of clinical programs or revocation of marketing approvals[268]. - The company discontinued development of its previous lead candidate, SEP-786, due to two unanticipated severe (Grade 3) events of elevated unconjugated bilirubin observed in the Phase 1 trial[269]. - The FDA required a boxed warning for NATPARA related to the risk of osteosarcoma, which may impact the commercial value of similar product candidates[270]. - Only a small percentage of drugs in development successfully complete the FDA approval process, which poses a significant risk to the company's financial condition and prospects[278]. - Patient enrollment and retention in clinical trials are critical and can be affected by various factors, including the nature of the patient population and competing treatments[279]. - The company may face significant delays or inability to obtain regulatory approvals due to safety concerns raised during the review process[277]. - The company may encounter substantial delays in clinical trials due to regulatory suspensions or terminations, impacting overall development timelines[263]. - The risk of failure in developing product candidates is high, with numerous factors beyond the company's control affecting outcomes[258]. - Manufacturing and formulation changes may necessitate additional testing, potentially delaying the commercialization of product candidates[267]. - The approval of product candidates may come with limitations on indicated uses and conditions of approval, impacting market potential[286]. Regulatory and Compliance Challenges - The company must ensure compliance with extensive regulatory requirements, including cGMP regulations, to avoid penalties and maintain product approvals[284]. - The company must provide six months' notice to the FDA for any changes in marketing status of approved drugs, or risk losing marketing approval[288]. - Ongoing regulatory obligations post-approval may result in significant additional expenses and penalties for non-compliance[283]. - The FDA may impose additional requirements for post-marketing studies or clinical trials, which could increase costs and affect product availability[286]. - The company is subject to evolving data protection laws, including the CCPA, which imposes fines of up to $7,500 per intentional violation[396]. - Non-compliance with GDPR could result in fines of up to €20 million or 4% of annual global revenues, whichever is greater[401]. - The company faces legal and compliance challenges due to varying state privacy laws, which may increase operational costs and risks[397]. - The NIS 2 Directive will impose direct obligations on management for compliance, with potential administrative fines of up to €10 million or 2% of worldwide turnover for non-compliance[404]. - The company may face significant costs and liabilities due to compliance with environmental, health, and safety laws, which could adversely affect its financial condition and operating results[350]. - The company may incur substantial costs related to compliance with healthcare fraud and abuse laws, which could divert management's attention from core operations[424]. - Compliance with U.S. and foreign laws regarding export controls and anti-corruption could hinder competitive ability and result in severe penalties[431]. Market and Competitive Landscape - The commercial success of approved products will depend significantly on third-party payors providing adequate coverage and reimbursement, which may be influenced by healthcare reform measures[256]. - The company faces significant competition from major pharmaceutical and biotechnology companies, which may impact its ability to commercialize products successfully[317]. - Competitors may have greater financial, technical, and marketing resources, which could affect the company's market position if it obtains product approvals[321]. - Mergers and acquisitions in the industry may concentrate resources among competitors, increasing the competitive landscape for the company[322]. - The company is aware of several competitors with products addressing similar indications, including Takeda and Ascendis Pharma, which may affect its market strategy[320]. - The company may need to reallocate resources and reprioritize development programs based on ongoing evaluations of the competitive landscape[320]. - The total addressable market for the company's product candidates may be smaller than estimated, affecting revenue and business operations[330]. - Future growth may depend on the company's ability to commercialize products in foreign markets, which involves additional regulatory burdens and uncertainties[329]. Human Resources and Management - As of December 31, 2024, the company had 75 full-time employees and anticipates needing to expand its workforce to support growth in research and development[335]. - The company is highly dependent on its senior management team, and the loss of key personnel could impede the achievement of its objectives[339]. - Attracting and retaining qualified personnel is challenging due to competition from other companies, which may limit the company's development objectives[340]. Strategic Initiatives and Future Outlook - The company may pursue opportunities to acquire or in-license additional businesses or technologies, but success is not guaranteed[300]. - The company intends to seek marketing approval for its product candidates in the United States and selected foreign jurisdictions, including the EU, where pricing is subject to governmental control and market regulations[323]. - The company may seek Fast Track Designation for product candidates intended for serious conditions, but there is no assurance that the FDA will grant it[383]. - The company plans to participate in the PRIME scheme in the EU for product candidates addressing unmet medical needs, which could provide benefits like early regulatory dialogue[384]. - The company may pursue Breakthrough Therapy Designation for products showing substantial improvement over existing therapies, but this designation is at the FDA's discretion[385][386]. - Priority review may be sought for products treating serious conditions, potentially shortening the FDA's review timeline from ten months to six months[389]. - The company aims to utilize expedited approval pathways, such as accelerated approval, for product candidates designed to treat serious conditions[391]. Risks and Uncertainties - The company is exposed to risks from changes in U.S. and international trade policies, particularly regarding tariffs and export controls affecting products manufactured in China[346]. - The company may not be able to maintain adequate insurance coverage for product liability claims, which could lead to substantial liabilities[348]. - Misconduct by employees or third parties could result in regulatory sanctions and harm the company's reputation, impacting business operations[345]. - The company may face limitations on utilizing NOLs and tax credits due to ownership changes, potentially increasing future tax liabilities[354]. - Cybersecurity threats are increasing in frequency and sophistication, posing risks to the company's sensitive data and operations[362]. - The company relies on third-party information systems, which introduces vulnerabilities and potential supply-chain attacks[371]. - Disruptions at the FDA and other regulatory agencies could hinder product development and approval processes, negatively impacting business operations[376]. - The company is exposed to significant financial and legal risks if cybersecurity incidents occur, including potential reputational damage[365]. - Remote work has increased risks to information technology systems, as employees use devices outside the company's secure network[366]. - The company may face challenges in maintaining adequate insurance coverage for cybersecurity-related liabilities[369]. - The unpredictability of future tax laws and regulations may increase tax liabilities for the company and its stockholders[427]. - Significant changes in government priorities and spending could materially impact results of operations and liquidity[429]. - The company faces potential legal liabilities and reputational harm due to the use of artificial intelligence technologies in its operations[409]. - The rapid evolution of artificial intelligence technologies will require significant resources for compliance with applicable laws and regulations[412].

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].