Core Viewpoint - HC Wainwright has initiated coverage on Septerna, Inc., highlighting its innovative drug design platform targeting previously undruggable G protein-coupled receptors (GPCRs) [1][3] Company Overview - Septerna is focused on GPCR drug discovery through its proprietary Native Complex Platform, aiming to maximize the potential of GPCR therapies [1] - The company has a deep pipeline of oral small molecule product candidates targeting endocrinology, immunology and inflammation, and metabolic diseases [2] Financial Insights - Analyst Raghuram Selvaraju noted that Septerna trades at a discount to its cash position and recent partnership cash, presenting a risk-mitigated investment opportunity with multiple catalysts expected in the next 6 to 12 months [3][7] - HC Wainwright has set a Buy rating for Septerna with a price target of $26 [3] Drug Development - The leading drug candidate, SEP-631, is a selective oral small molecule MRGPRX2 negative allosteric modulator for mast cell diseases, including chronic spontaneous urticaria (CSU) [4] - SEP-631 could provide a unique treatment option for CSU patients due to its selective mast cell inhibition and potential for combination therapy [4] Market Potential - If SEP-631 can match the efficacy of Novartis and Roche's Xolair, which generated nearly $3.9 billion in sales in 2023, it could achieve blockbuster status [5] - Septerna has entered an exclusive global collaboration with Novo Nordisk for the development of oral small-molecule medicines for obesity, type 2 diabetes, and other cardiometabolic diseases, starting with four development programs [6] Valuation Perspective - HC Wainwright emphasized that the financial implications of the partnership suggest Septerna's implied enterprise value may be negligible or negative, indicating the company is undervalued [7]

Septerna (SEPN) 2025 Conference June 05, 2025 03:45 PM ET Speaker0 Hello, and welcome to the Jefferies twenty twenty five Global Healthcare Conference. My name is Chase Booken with the Jefferies Healthcare Banking team, and it is my great pleasure to introduce Jeff Feiner, CEO of Subturno. Jeff? Speaker1 Okay, thanks Chase and thanks to Jefferies for the invitation to introduce some of you to Subturno for the first time and for others to give you an update. I need to say that my presentation will include so ...

Company Overview - Septerna, Inc. is a biotechnology company focused on G protein-coupled receptor (GPCR) drug discovery, utilizing its proprietary Native Complex Platform™ to enhance GPCR therapies [3] - The company has developed a deep pipeline of oral small molecule product candidates targeting three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases [3] Upcoming Event - Jeffrey Finer, M.D., Ph.D., CEO and Co-founder of Septerna, will present at the Jefferies Global Healthcare Conference on June 5, 2025, at 3:45 p.m. ET in New York [1] - A live webcast of the presentation will be available on the company's website and will be archived for at least 30 days [2]

Core Viewpoint - The S&P 500 has experienced persistent volatility in 2025, leading to cautious investor sentiment, but this environment may present opportunities for significant gains for those willing to take moderate risks [1]. Group 1: Septerna Inc. - Septerna Inc. is a clinical-stage biotechnology firm focused on developing G protein-coupled receptor (GPCR) oral small molecule drug candidates for various diseases [4][6]. - The company has secured a major partnership with Novo Nordisk, which could enhance its growth potential, with an immediate payment of approximately $200 million and a deal potentially worth over $2 billion [5][6]. - Analysts have a consensus price target of $27 per share for Septerna, indicating a potential upside of 184.81% from the current price of $9.48, despite the stock having fallen by about 58% year-to-date [7][4]. Group 2: Intellia Therapeutics Inc. - Intellia Therapeutics is a genome editing firm developing therapies for conditions such as hemophilia and cancers, with promising trial data reported for its ongoing Phase 1 trial [9][10]. - The company has a strong cash position of $707 million as of March 31, 2025, which is expected to fund operations through early 2027 [10]. - The consensus price target for Intellia shares is $36.90, suggesting a potential quadrupling of the stock's current price, with 14 out of 21 analysts rating the stock as a Buy [11]. Group 3: Novavax Inc. - Novavax has received full FDA approval for its protein-based COVID-19 vaccine, unlocking a $175 million milestone payment from Sanofi, positioning it as a non-mRNA option [12][13]. - Despite the approval, the FDA has imposed significant restrictions that may limit the vaccine's availability, contributing to mixed market reactions [13]. - The consensus price target for Novavax shares is $19, indicating a potential upside of 160.63%, with four out of seven analysts rating the stock as a Buy [12][13].

Shares of Septerna, Inc. (SEPN) have gained 57.8% over the past four weeks to close the last trading session at $9.42, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $23.67 indicates a potential upside of 151.3%.The average comprises three short-term price targets ranging from a low of $18 to a high of $28, with a standard deviation of $5.13. While the lowest estimate indicates ...

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]

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]