Septerna, Inc.(SEPN)
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Septerna, Inc.(SEPN) - 2025 Q2 - Quarterly Results
2025-08-11 20:06
[Executive Summary](index=1&type=section&id=Executive%20Summary) This section summarizes Septerna's clinical advancements, financial strengthening, and key leadership changes [Key Business Progress and Milestones](index=1&type=section&id=Key%20Business%20Progress%20and%20Milestones) Septerna is actively advancing its clinical pipeline, initiating a Phase 1 trial for SEP-631 for mast cell diseases and progressing its PTH1R agonist program towards development candidate selection and a Phase 1 trial in early 2026 - Initiating Phase 1 Trial for SEP-631, MRGPRX2 NAM Program, for Mast Cell Diseases in **Q3 2025** [2](index=2&type=chunk)[3](index=3&type=chunk)[7](index=7&type=chunk) - Advancing selection of a next-generation oral small molecule PTH1R Agonist for clinical development in **Q3 2025**, with a Phase 1 trial planned for **H1 2026** [2](index=2&type=chunk)[3](index=3&type=chunk)[7](index=7&type=chunk) [Financial Outlook and Strategy](index=1&type=section&id=Financial%20Outlook%20and%20Strategy) The company's financial position has been significantly bolstered by the effective collaboration with Novo Nordisk, extending its cash runway well into 2029 - Updated cash runway expected to support operating plans at least into **2029**, bolstered by the Novo Nordisk collaboration [2](index=2&type=chunk)[3](index=3&type=chunk)[14](index=14&type=chunk) [Corporate Overview and Program Updates](index=1&type=section&id=Corporate%20Overview%20and%20Anticipated%20Milestones) This section covers Septerna's leadership, Novo Nordisk collaboration, and pipeline program advancements [Leadership Update](index=1&type=section&id=Leadership%20Update) Septerna announced the promotion of Liz Bhatt, MS, MBA, to President, effective August 1, 2025, recognizing her instrumental role in strategic partnerships and company growth - **Liz Bhatt**, COO, promoted to President, effective **August 1, 2025** [6](index=6&type=chunk) - Ms. Bhatt was instrumental in securing the multi-billion-dollar strategic partnership with Novo Nordisk and guiding Septerna through a successful IPO in **2024** [9](index=9&type=chunk) [Collaboration with Novo Nordisk](index=1&type=section&id=Collaboration%20Agreement%20with%20Novo%20Nordisk) The global collaboration and license agreement with Novo Nordisk became effective on July 1, 2025, initiating joint R&D efforts for cardiometabolic diseases and resulting in a $195 million upfront payment to Septerna - Global collaboration and license agreement with Novo Nordisk became effective on **July 1, 2025**, focusing on oral small molecule therapies for obesity, type 2 diabetes, and other cardiometabolic diseases [7](index=7&type=chunk) - Septerna received a **$195 million upfront payment** in **July 2025** in connection with the agreement's effectiveness [7](index=7&type=chunk) [Pipeline Program Updates](index=1&type=section&id=Pipeline%20Program%20Updates) Septerna provided updates on its key pipeline programs, including the initiation of a Phase 1 trial for SEP-631, progress towards a development candidate for its PTH1R agonist, and advancement of its TSHR NAM and discovery programs [SEP-631 MRGPRX2 NAM Program](index=1&type=section&id=SEP-631%20MRGPRX2%20NAM%20Program) Septerna is initiating a Phase 1 clinical trial for SEP-631, an oral small molecule for mast cell diseases, in healthy volunteers during Q3 2025 - Initiating a Phase 1 clinical trial for SEP-631 in healthy volunteers in **Q3 2025** to assess safety, tolerability, pharmacokinetics, and pharmacodynamics [7](index=7&type=chunk) - SEP-631 is a selective oral small molecule MRGPRX2 negative allosteric modulator (NAM) for mast cell diseases, including chronic spontaneous urticaria [7](index=7&type=chunk) [PTH1R Agonist Program](index=1&type=section&id=PTH1R%20Agonist%20Program) The PTH1R agonist program for hypoparathyroidism is on track to select a next-generation development candidate in Q3 2025, with a Phase 1 clinical trial planned for H1 2026 - Tracking towards selection of a next-generation PTH1R agonist development candidate in **Q3 2025** [7](index=7&type=chunk) - Plans to commence a Phase 1 clinical trial in **H1 2026**, following successful completion of preclinical development activities [7](index=7&type=chunk) - Goal is to provide full-day calcium control in hypoparathyroidism patients [7](index=7&type=chunk) [TSHR NAM Program](index=1&type=section&id=TSHR%20NAM%20Program) Septerna is making progress on its TSHR NAM program, moving multiple lead compounds closer to development candidate selection for Graves' disease and thyroid eye disease - Progressing multiple lead compounds closer to development candidate selection for a potential disease-modifying oral treatment for Graves' disease and thyroid eye disease [7](index=7&type=chunk) [Discovery Programs](index=1&type=section&id=Discovery%20Programs) The company continues to advance its discovery-stage programs across multiple therapeutic areas, leveraging its Native Complex Platform™ - Advancing discovery-stage programs utilizing its Native Complex Platform™ across multiple therapeutic areas [7](index=7&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) This section details Septerna's Q2 2025 financial results, including key highlights, statements of operations, and balance sheet [Summary Financial Highlights](index=3&type=section&id=Summary%20Financial%20Highlights) Septerna reported a net loss of $24.8 million for Q2 2025, with increased R&D and G&A expenses compared to the prior year, while its cash position was strengthened by the Novo Nordisk upfront payment Key Financial Highlights (Q2 2025 vs. Q2 2024) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :----------------------- | :------------------ | :------------------ | :------------ | | Cash, cash equivalents, and marketable securities (as of June 30) | $379.2 | N/A | N/A | | R&D Expenses | $22.2 | $15.0 | +48.0% | | G&A Expenses | $6.9 | $3.4 | +102.9% | | Net Loss | $(24.8) | $(16.4) | +51.2% | - Cash, cash equivalents, and marketable securities totaled **$379.2 million** as of June 30, 2025. Following receipt of the **$195.0 million upfront payment** from Novo Nordisk in July, Septerna now expects its cash runway to extend at least into **2029** [14](index=14&type=chunk) [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) The condensed statements of operations show a net loss of $24.8 million for the three months ended June 30, 2025, an increase from $16.4 million in the prior year, driven by higher R&D and G&A expenses Condensed Statements of Operations (Unaudited, In thousands) | | Three Months Ended June 30, | | Six Months Ended June 30, | | :------------------------------------------ | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Revenue | $119 | $370 | $338 | $687 | | Operating expenses: | | | | | | Research and development | 22,188 | 15,035 | 41,459 | 28,188 | | General and administrative | 6,909 | 3,400 | 13,767 | 6,054 | | Total operating expenses | 29,097 | 18,435 | 55,226 | 34,242 | | Loss from operations | (28,978) | (18,065) | (54,888) | (33,555) | | Interest and other income, net | 4,140 | 1,515 | 8,574 | 2,746 | | Benefit for income taxes | — | 109 | — | 202 | | Net loss attributable to common stockholders | $(24,838) | $(16,441) | $(46,314) | $(30,607) | | Net loss per share attributable to common stockholders, basic and diluted | $(0.56) | $(7.03) | $(1.05) | $(13.40) | | Weighted-average shares outstanding, basic and diluted | 44,165,168 | 2,337,585 | 44,051,918 | 2,284,414 | [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, Septerna reported total assets of $415.2 million and total stockholders' equity of $377.6 million, with cash, cash equivalents, and marketable securities at $379.2 million Condensed Balance Sheets (Unaudited, In thousands) | | June 30, | | December 31, | | :------------------------------------------ | :--- | :--- | :--- | :--- | | | **2025** | | **2024** | | Cash, cash equivalents and marketable securities | $379,194 | | $420,789 | | Working capital | 319,014 | | 343,975 | | Total assets | 415,231 | | 456,554 | | Total liabilities | 37,674 | | 36,507 | | Additional paid-in capital | 542,024 | | 538,321 | | Accumulated deficit | (164,688) | | (118,374) | | Total stockholders' equity | 377,557 | | 420,047 | [About Septerna](index=3&type=section&id=About%20Septerna) This section describes Septerna's company profile, Native Complex Platform™, and GPCR drug discovery focus [Company Profile and Platform](index=3&type=section&id=Company%20Profile%20and%20Platform) Septerna is a biotechnology company focused on G protein-coupled receptor (GPCR) drug discovery, utilizing its proprietary Native Complex Platform™ to develop oral small molecule therapies across endocrinology, immunology and inflammation, and metabolic diseases - Septerna, Inc. is a biotechnology company pioneering a new era of GPCR drug discovery [11](index=11&type=chunk) - Utilizes its proprietary Native Complex Platform™ to discover and develop a deep pipeline of oral small molecule product candidates [11](index=11&type=chunk) - Initial therapeutic areas of focus include endocrinology, immunology and inflammation, and metabolic diseases [11](index=11&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines disclaimers for forward-looking statements, emphasizing risks and uncertainties for future results [Disclaimer and Risk Factors](index=3&type=section&id=Disclaimer%20and%20Risk%20Factors) This section serves as a disclaimer for forward-looking statements, highlighting that actual results may differ materially due to various risks and uncertainties, including those related to clinical trials, regulatory approvals, intellectual property, and economic conditions - The press release contains forward-looking statements regarding Septerna's beliefs and expectations, including program advancements, clinical trial initiations, and financial outlook [12](index=12&type=chunk) - These statements are subject to risks, uncertainties, and important factors that may cause actual events or results to differ materially [13](index=13&type=chunk) - Risks include uncertainties related to the Novo Nordisk collaboration, product candidates entering clinical trials, regulatory approvals, clinical development outcomes, intellectual property, and general economic conditions [13](index=13&type=chunk)
Septerna Highlights Business Progress and Reports Second Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-11 20:01
Core Insights - Septerna, Inc. is advancing its next-generation oral small molecule PTH1R agonist program for hypoparathyroidism, with plans to select a development candidate in Q3 2025 and initiate a Phase 1 clinical trial in H1 2026 [2][3] - The company is also initiating a Phase 1 clinical trial for SEP-631, an oral small molecule for mast cell diseases, in Q3 2025 [7] - Septerna's cash position is strong, with $379.2 million in cash and equivalents as of June 30, 2025, and an expected cash runway extending into 2029 following a $195 million upfront payment from Novo Nordisk [12][15] PTH1R Agonist Program - The PTH1R agonist program aims to provide full-day calcium control for patients with hypoparathyroidism, with a development candidate selection expected in Q3 2025 [3] - A Phase 1 clinical trial is planned to commence in the first half of 2026 after successful preclinical development [3] SEP-631 MRGPRX2 NAM Program - SEP-631 is a selective oral small molecule MRGPRX2 negative allosteric modulator for mast cell diseases, with a Phase 1 trial to assess safety and tolerability in healthy volunteers starting in Q3 2025 [7] Collaboration with Novo Nordisk - A global collaboration and license agreement with Novo Nordisk became effective on July 1, 2025, focusing on the discovery and development of oral small molecule therapies for obesity, type 2 diabetes, and other cardiometabolic diseases [7] - Septerna received a $195 million upfront payment as part of this collaboration [7] Business Highlights - The company continues to progress its TSHR NAM program, moving multiple lead compounds closer to development candidate selection for treating Graves' disease and thyroid eye disease [7] - Septerna's discovery-stage programs are advancing across various therapeutic areas utilizing its Native Complex Platform™ [7] Financial Results - For Q2 2025, Septerna reported R&D expenses of $22.2 million, up from $15.0 million in Q2 2024, and G&A expenses of $6.9 million, compared to $3.4 million in the same period [12] - The net loss for Q2 2025 was $24.8 million, compared to a net loss of $16.4 million in Q2 2024 [12][14]
Analyst Flags Septerna As Undervalued Biotech Play With Significant Upside
Benzinga· 2025-06-23 18:30
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 Transcript
2025-06-05 20:45
Summary of Septerna (SEPN) 2025 Conference Call Company Overview - **Company**: Septerna (SEPN) - **Focus**: Development of drugs targeting G protein-coupled receptors (GPCRs) using a proprietary platform called the native complex platform [1][2] Portfolio Strategy - **Target Selection**: Focus on biologically and clinically validated targets with significant unmet needs and market opportunities [2] - **Current Programs**: Discussion of four main programs, including a parathyroid hormone receptor agonist, MRGPRX2, thyroid stimulating hormone receptor negative allosteric modulator, and an incretin receptor agonist [3][4] Financial Position - **Capitalization**: Well-capitalized following an IPO in October and a recent collaboration with Novo Nordisk, providing a strong financial position for ongoing research and development [3][54] Key Programs 1. **Parathyroid Hormone Receptor Agonist Program** - **Target**: Oral small molecules for hypoparathyroidism [16] - **Challenges**: Discontinued trial of first compound (SEP-786) due to unanticipated bilirubin levels, but ongoing investigation into next-generation compounds [23][24][26] - **Animal Model Results**: Promising results in normalizing calcium levels in hypoparathyroid rat models with new compounds showing lower dosing requirements compared to SEP-786 [29][31][34] 2. **MRGPRX2 Program** - **Target**: Mast cell diseases, including chronic spontaneous urticaria and allergic asthma [35][37] - **Compound**: SEP-631, a negative allosteric modulator showing potent inhibition of receptor activation and promising preclinical results [38][42] - **Clinical Timeline**: Expected to enter Phase 1 trials in Q3 [43] 3. **Thyroid Stimulating Hormone Receptor Program** - **Focus**: Treating Graves' disease and thyroid eye disease with a negative allosteric modulator [44] - **Mechanism**: Aiming for a universal approach to target multiple autoantibodies in patients [45][46] 4. **Incretin Receptor Agonist Program** - **Innovation**: Discovery of a novel binding pocket allowing for the development of multi-incretin receptor agonists [50] - **Preclinical Results**: Early-stage molecules showing weight loss effects comparable to existing treatments [52] Collaboration with Novo Nordisk - **Details**: Collaboration includes three known targets and two undisclosed targets, with an upfront payment of $195 million and Novo responsible for all R&D costs [53][54] Leadership and Future Outlook - **Team**: Experienced leadership with decades of industry experience and a strong advisory board [55] - **Market Potential**: Each program represents a significant market opportunity, with ongoing efforts to extend financial runway into early 2028 and beyond [56] Conclusion - **Overall Position**: Septerna is well-positioned in the GPCR drug discovery space with a robust pipeline and strategic collaborations, aiming to address significant unmet medical needs across various therapeutic areas [56]
Septerna to Present at Jefferies Global Healthcare Conference
Globenewswire· 2025-05-29 12:00
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]
Analysts Think These Stocks Could More Than Double in Value
MarketBeat· 2025-05-23 11:46
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].
Does Septerna, Inc. (SEPN) Have the Potential to Rally 151.27% as Wall Street Analysts Expect?
ZACKS· 2025-05-21 15:01
Group 1 - Septerna, Inc. (SEPN) shares have increased by 57.8% over the past four weeks, closing at $9.42, with a mean price target of $23.67 indicating a potential upside of 151.3% [1] - The average price targets range from a low of $18 to a high of $28, with a standard deviation of $5.13, suggesting a high degree of agreement among analysts [2] - Analysts show strong optimism regarding SEPN's earnings prospects, as indicated by a 63.2% increase in the Zacks Consensus Estimate for the current year, with no negative revisions [12][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 [13] - The consensus price target may not be a reliable indicator of the stock's potential gain, but the direction of price movement implied by it appears to be a good guide [13][10]
Septerna: Novo's Investment In Incretin Program Intrigues - One For The Watchlist
Seeking Alpha· 2025-05-16 20:32
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]
Septerna, Inc.(SEPN) - 2025 Q1 - Quarterly Report
2025-05-15 20:09
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 ( ...
Septerna, Inc.(SEPN) - 2025 Q1 - Quarterly Results
2025-05-15 20:07
[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)