SOUTH SAN FRANCISCO, Calif., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced that management will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Tuesday, December 2, 2025, at 10:25 a.m. ET in Coral Gables, Florida. A live webcast of the presentation will be available in the investors section of the company’s website at www.sept ...

Group 1 - Septerna, Inc. reported a 3Q25 GAAP EPS of $0.18, indicating a significant improvement from previous losses, primarily driven by partnership-related revenue [1] - The company has a focus on biotechnology, emphasizing innovative approaches in drug development, including novel mechanisms of action and first-in-class therapies [1] - The analysis aims to evaluate the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities while balancing financial fundamentals and valuation [1]

Summary of Septerna Conference Call Company Overview - **Company**: Septerna (NasdaqGM:SEPN) - **Focus**: Drug discovery targeting G protein-coupled receptors (GPCRs) using the Native Complex Platform - **Financial Position**: Cash runway into at least 2029 [4][4][4] Key Programs SEP631 - **Type**: MRGPRX2 inhibitor, currently in Phase 1 clinical trials - **Indication**: Mast cell-driven diseases - **Expected Readouts**: First half of the upcoming year [3][4][5] - **Mechanism**: Targets MRGPRX2, leading to mast cell degranulation through an IgE-independent pathway [5][6] - **Profile**: - High potency (single-digit nanomolar to high picomolar) - Excellent oral bioavailability with once-daily dosing projected - Good preclinical safety profile [6][6][11] - **Phase 1 Trial Design**: Randomized placebo-controlled, includes skin challenge with Icatibant [8][9][17] SEP479 - **Type**: PTH1 receptor agonist for hypoparathyroidism, expected to enter the clinic in the first half of next year [3][28] - **Challenges**: Historically difficult target for small molecules; previous candidate (SEP786) faced issues with bilirubin increases [29][30] - **Current Status**: - New compound shows no UGT1A1 inhibition or bilirubin increase - Predicted human half-life of 40-80 hours, aiming for once-daily oral dosing [30][31] - **Clinical Goals**: - Aim for serum calcium increases of about 1 mg/dL in Phase 1 trials - Final IND enabling studies wrapping up, including a 28-day GLP-tox study in monkeys [33][34][40] Future Directions - **Phase 2 Strategy**: Plans to move into chronic spontaneous urticaria (CSU) trials post-Phase 1 [22][26] - **Exploration of Other Indications**: Potential for expansion into asthma and pain-related conditions involving mast cells [26][26] - **Collaboration with Novo**: Developing a TSH receptor negative allosteric modulator, with hopes for a development candidate next year [41][42] Additional Insights - **Safety Profile**: SEP631 has shown no liver involvement in preclinical studies, distinguishing it from other X2 agonists [11][12] - **Market Opportunities**: Significant market potential for both SEP631 and SEP479 due to their targeted mechanisms and the unmet medical needs in their respective indications [4][4][28]

Summary of Septerna's Conference Call Company Overview - **Company**: Septerna - **Focus**: G protein-coupled receptors (GPCRs) and small molecule discovery using the Native Complex platform - **Financial Position**: Well-capitalized with an operating cash runway into at least 2029 [2][2][2] Key Programs 1. **SEP479 Program** - **Target**: Parathyroid hormone receptor agonist for hyperparathyroidism - **Clinical Development**: Anticipated entry into the clinic in the first half of next year [3][3][9] - **Pharmacodynamics**: Demonstrated ability to normalize serum calcium and phosphate levels in preclinical studies with low dosing (0.15 mg/kg) [7][7][8] - **Safety Profile**: Improved pharmaceutical properties compared to previous candidate SEP786, which was discontinued due to safety issues related to bilirubin levels [6][14][15] - **Half-Life**: Predicted human half-life of 40-80 hours, supporting once-daily dosing [7][17][17] 2. **SEP631 Program** - **Target**: MRGPRX2 negative allosteric modulator for mast cell-driven diseases, including chronic spontaneous urticaria - **Clinical Development**: Currently in phase one trial, with data expected in early 2026 [9][12][25] - **Pharmacodynamics**: Demonstrated complete inhibition of extravasation in preclinical models [11][11] - **Differentiation**: Unique profile as an insurmountable negative allosteric modulator, potentially offering a long duration of action [10][19] 3. **Thyroid-Stimulating Hormone Receptor Program** - **Target**: Graves' disease and thyroid eye disease - **Market Opportunity**: Significant unmet need with a large market size; current treatments are outdated [26][26][27] - **Mechanism**: Utilizing an insurmountable negative allosteric modulator approach to inhibit receptor activation by various antibodies [27][28] Collaborations and Financials - **Collaboration with Novo Nordisk**: Announced a significant collaboration in May, including $195 million upfront and full support for R&D costs [4][4] Market Context and Competitive Landscape - **Mast Cell Indications**: Potential to target multiple mast cell-driven diseases, with chronic spontaneous urticaria as the initial focus [21][21] - **Competitive Landscape**: Acknowledgment of a crowded market for chronic spontaneous urticaria treatments, with a focus on differentiating SEP631 from existing therapies [22][22][19] Future Outlook - **Pipeline Expansion**: The platform has broader applications for GPCRs, with potential for a deep pipeline of products targeting various therapeutic areas [29][30] - **Clinical Trials**: Plans to initiate trials for SEP631 in chronic spontaneous urticaria following successful phase one results [25][25] Conclusion - **Overall Sentiment**: Positive outlook on the progress of Septerna's programs, with a focus on advancing clinical development and addressing significant market needs in the biopharma space [30][30]

Core Insights - Septerna, Inc. reported a quarterly loss of $0.09 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.19, marking an earnings surprise of -147.37% [1] - The company's revenues for the quarter ended September 2025 were $21.5 million, missing the Zacks Consensus Estimate by 71.34%, compared to revenues of $0.18 million a year ago [2] - The stock has underperformed, losing about 19.2% since the beginning of the year, while the S&P 500 gained 14.4% [3] Financial Performance - Over the last four quarters, Septerna has surpassed consensus EPS estimates only once [2] - The current consensus EPS estimate for the upcoming quarter is $0.26 on revenues of $46.5 million, and for the current fiscal year, it is -$1.00 on revenues of $140.34 million [7] Industry Context - Septerna operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 36% of over 250 Zacks industries [8] - The industry has shown a strong correlation between near-term stock movements and trends in earnings estimate revisions, indicating that the performance of Septerna may be influenced by broader industry trends [5][8] Future Outlook - The company's earnings outlook will be crucial for assessing future stock performance, particularly in light of management's commentary during the earnings call [4] - The estimate revisions trend for Septerna was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market [6]

Financial Performance - The company recorded a net income of $4.2 million for the year ended December 31, 2023, due to a gain on the sale of a non-financial asset of $47.6 million[136]. - For the three months ended September 30, 2025, the company reported a net income of $8.2 million, driven by $21.5 million in revenue and a $12.5 million gain on the sale of a non-financial asset[136]. - The company has an accumulated deficit of $156.5 million as of September 30, 2025, with net losses of $38.1 million and $51.1 million for the nine months ended September 30, 2025, and 2024, respectively[138]. - Revenue for the three months ended September 30, 2025, was $21.5 million, a significant increase from $0.2 million in the same period of 2024[169]. - For the nine months ended September 30, 2025, revenue reached $21.8 million, compared to $0.9 million for the same period in 2024[169]. - $21.3 million of the total revenue for the three and nine months ended September 30, 2025, was generated from research activities performed for Novo under the Novo Collaboration Agreement[170]. - The net loss for the three months ended September 30, 2025, was $8.2 million, a decrease in loss compared to $20.5 million in the same period of 2024[168]. - The company reported a net loss of $38.1 million for the nine months ended September 30, 2025, compared to a net loss of $51.1 million in 2024, a 25.5% improvement[180]. Collaboration Agreements - The company received a one-time, non-refundable upfront payment of $195.0 million from the Novo Collaboration Agreement, recorded as deferred revenue[144]. - The company is eligible for up to approximately $498.0 million in milestone payments from the Novo Collaboration Agreement, along with tiered royalties based on global product sales[144][145]. - The company received a one-time, non-refundable upfront payment of $195.0 million in July 2025 as part of the Novo Collaboration Agreement[182]. Research and Development - The company plans to initiate a Phase 1 clinical trial for SEP-479 in the first half of 2026, pending completion of preclinical studies and regulatory submissions[131]. - The Phase 1 clinical trial for SEP-631 is expected to enroll up to approximately 150 healthy adult volunteers, with initial data anticipated in the first half of 2026[132]. - The company has incurred significant operating losses since inception, with expectations to continue incurring substantial expenditures for product development and operational activities[137]. - The company expects research and development expenses to increase substantially in absolute dollars as it continues to invest in product candidates and clinical trials[157]. - Research and development expenses for the three months ended September 30, 2025, were $24.3 million, up from $17.8 million in the same period of 2024, reflecting an increase of $6.4 million[168]. - For the nine months ended September 30, 2025, research and development expenses were $65.7 million, up from $46.0 million in 2024, marking a 42.5% increase[172]. - The company anticipates initiating a Phase 1 clinical trial for SEP-479 in the first half of 2026, following the completion of preclinical studies and regulatory submissions[173]. Operating Expenses - General and administrative expenses for the three months ended September 30, 2025, were $7.1 million, an increase of $2.2 million from $4.9 million in the same period of 2024[168]. - General and administrative expenses are also expected to increase significantly as the company expands its headcount to support business growth[162]. - General and administrative expenses rose to $7.1 million for the three months ended September 30, 2025, compared to $4.9 million in 2024, a 44.9% increase[174]. - The company recorded a gain of $12.5 million on the sale of a non-financial asset, impacting total operating expenses for the three months ended September 30, 2025[168]. Cash and Financing - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $561.6 million, expected to fund operations through at least 2029[182]. - Net cash provided by operating activities was $125.2 million for the nine months ended September 30, 2025, compared to a net cash used of $46.5 million in 2024[184]. - The company completed its IPO in October 2024, raising net proceeds of $302.8 million from the sale of 18.4 million shares[140]. - The company completed its IPO in October 2024, resulting in net proceeds of $302.8 million after total offering costs of $28.4 million[193]. - The company has historically financed operations primarily through convertible promissory notes, convertible preferred stock, and the recent IPO[193]. Accounting and Compliance - There have been no material changes to the company's critical accounting policies and estimates during the nine months ended September 30, 2025[196]. - Revenue is recognized under ASC 606 when the customer obtains control of the promised goods or services[197]. - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of new accounting standards[199]. - The company may continue to qualify as a "smaller reporting company" if certain revenue and market value thresholds are met[199]. Strategic Focus - The company is focused on establishing collaborations for favorable terms and scaling up clinical, regulatory, and manufacturing capabilities[194]. - Future commercialization activities will require expenses for sales, marketing, manufacturing, and distribution capabilities[194]. - The company has devoted resources to developing product candidates and preparing for clinical trials[193]. - The company has engaged in collaboration activities and established arrangements for the manufacture of product candidates[193].

Financial Performance - Revenue for the third quarter of 2025 was $21.5 million, a significant increase from $0.2 million in the same quarter of 2024[7] - Net income for the third quarter of 2025 was $8.2 million, a turnaround from a net loss of $20.5 million in Q3 2024[11] - Total stockholders' equity as of September 30, 2025, was $388.7 million, down from $420.0 million at the end of 2024[16] Expenses - Research and development expenses were $24.3 million for Q3 2025, compared to $17.8 million for Q3 2024, reflecting a 36.9% increase[11] - General and administrative expenses rose to $7.1 million in Q3 2025 from $4.9 million in Q3 2024, marking a 45.9% increase[11] Cash Position - Septerna reported a robust cash position of $561.6 million as of September 30, 2025, expected to fund operations into at least 2029[6] Clinical Trials and Research - SEP-479 was selected as the next-generation oral PTH1R agonist candidate, with a Phase 1 clinical trial planned for the first half of 2026[6] - The ongoing Phase 1 clinical trial for SEP-631 is evaluating safety and pharmacokinetics, with initial data expected in the first half of 2026[6] - The company continues to advance its TSHR NAM program, aiming for a potential treatment for Graves' disease and thyroid eye disease[6] Collaborations - Septerna's collaboration with Novo Nordisk commenced in July 2025, focusing on developing oral small-molecule therapies for obesity and type 2 diabetes[6]

Core Insights - Septerna, Inc. has selected SEP-479 as its next-generation oral PTH1R agonist development candidate for hypoparathyroidism and is currently conducting a Phase 1 clinical trial for SEP-631 targeting MRGPRX2 for mast cell-driven diseases [2][3] - The company reported a robust financial position with cash, cash equivalents, and marketable securities totaling $561.6 million, expected to support operations at least into 2029 [1][13] Business Updates - SEP-479 demonstrated robust, dose-dependent increases in serum calcium and decreases in endogenous parathyroid hormone levels in a seven-day study in healthy cynomolgus monkeys, with plans to initiate a Phase 1 clinical trial in the first half of 2026 [7][3] - The ongoing Phase 1 clinical trial for SEP-631 is evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics, with initial data expected in the first half of 2026 [4][2] - Septerna is advancing its TSHR NAM program aimed at developing a potential oral treatment for Graves' disease and thyroid eye disease [8] Financial Performance - Revenue for the quarter ended September 30, 2025, was $21.5 million, a significant increase from $0.2 million in the same quarter of 2024, driven by the amortization of the $195 million upfront payment from Novo Nordisk [13] - Research and development expenses were $24.3 million for the quarter, compared to $17.8 million in the same quarter of 2024, while general and administrative expenses rose to $7.1 million from $4.9 million [13] - The company reported a net income of $8.2 million for the quarter, a turnaround from a net loss of $20.5 million in the same quarter of 2024 [13]

Company Overview - Septerna, Inc. (SEPN) shares increased by 7% to close at $22.49, with a notable trading volume, and have gained 38% over the past four weeks [1][2] - The stock price surge is attributed to growing investor optimism regarding Septerna's clinical candidate, SEP-631, aimed at treating chronic spontaneous urticaria and other mast cell diseases [2] Financial Performance - Septerna is expected to report quarterly earnings of $0.19 per share, reflecting a year-over-year increase of 102.3% [3] - Revenue projections for the upcoming quarter stand at $75 million, indicating a significant increase of 41566.7% compared to the same quarter last year [3] Market Position and Trends - The consensus EPS estimate for Septerna has remained stable over the last 30 days, suggesting that stock price movements may not sustain without earnings estimate revisions [4] - Septerna holds a Zacks Rank of 3 (Hold), indicating a neutral outlook in the market [4] - In comparison, Gyre Therapeutics, Inc. (GYRE), a peer in the same industry, has seen a decline of 5.2% over the past month and currently holds a Zacks Rank of 4 (Sell) [4][5]

Core Insights - Septerna, Inc. has appointed Dr. Keith Gottesdiener to its board of directors, who will chair a newly formed R&D Committee, bringing over 30 years of biotechnology experience [1][2] - Dr. Gottesdiener's expertise in advancing therapeutics and regulatory strategy is expected to support Septerna's lead programs and pipeline development [2] - The company is focused on GPCR drug discovery through its proprietary Native Complex Platform™, aiming to address unmet medical needs across various therapeutic areas [3] Company Overview - Septerna, Inc. is a clinical-stage biotechnology company specializing in GPCR therapies, with a strong team of experts and a diverse pipeline of oral small molecule drug candidates [3] - The company is advancing programs in endocrinology, immunology, inflammation, and metabolic diseases, both independently and in collaboration with partners [3] Leadership Background - Dr. Gottesdiener has held significant leadership roles, including President and CEO of Prime Medicine, Inc., and CEO of Rhythm Pharmaceuticals, Inc., where he oversaw the approval of setmelanotide for three obesity indications [2] - His previous experience includes 16 years at Merck Research Laboratories, where he was responsible for the approval of over 20 novel therapeutics and more than 200 IND submissions [2]