SEPN
SepternaCDocument history
Earnings documents stored for SEPN.
Investor releaseQuarter not tagged2026-08-10Septerna Highlights Business Progress and Reports Second Quarter 2026 Financial Results
GlobeNewswire
Septerna Highlights Business Progress and Reports Second Quarter 2026 Financial Results
Phase 1 Clinical Trial Ongoing for SEP-479, an Oral Small Molecule PTH1R Agonist SEP-479 Observed Clinical Pharmacokinetic Profile Supports Once-Daily Dosing; SAD / MAD Data Expected in Q1 2027 Cash Position of $516.5 Million Expected to Support Operating Plans at Least into 2029 SOUTH SAN FRANCISCO, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted pipeline progress and anticipated milestones and reported financial results for the second quarter ended June 30, 2026. “We continue to make meaningful progress across our portfolio as we execute on our strategy to develop differentiated oral medicines targeting GPCRs,” said Jeffrey Finer, M.D., Ph.D., Chief Executive Officer and Co-founder of Septerna. “We are advancing our Phase 1 study of SEP-479 and are very pleased with the observed clinical half-life, which is at the longer end of our preclinical estimates. This finding reinforces our confidence in the potential of SEP-479 as a differentiated, once-daily oral treatment for hypoparathyroidism, and we look forward to presenting SAD/MAD data in the first quarter of 2027. We are also advancing our broader portfolio by evaluating the next phase of development for SEP-631 in mast cell-driven diseases and progressing our TSHR program toward development candidate selection.” Recent Portfolio Progress and Anticipated Milestones SEP-479 PTH1R Agonist for Hypoparathyroidism: SEP-631 MRGPRX2 NAM for Mast Cell-Driven Diseases: TSHR NAM Program: Additional Programs: Second Quarter 2026 Financial Results Cash Position: Cash, cash equivalents, and marketable securities totaled $516.5 million as of June 30, 2026. Septerna expects its existing cash runway to fund operations at least into 2029. Revenue: Revenue from the Novo Nordisk collaboration was $26.7 million for the quarter ended June 30, 2026, compared to $0.1 million from Vertex for the quarter ended June 30, 2025. Revenue for the quarter ended June 30, 2026, included the amortization of $14.6 million of the $195.0 million upfront payment and $0.9 million from the achievement of $4.0 million in research milestones, in addition to $11.2 million for research services associated with the collaboration. R&D Expenses: Research and development (R&D) expenses were $35.1 mil…Read full documentShow less
Phase 1 Clinical Trial Ongoing for SEP-479, an Oral Small Molecule PTH1R Agonist SEP-479 Observed Clinical Pharmacokinetic Profile Supports Once-Daily Dosing; SAD / MAD Data Expected in Q1 2027 Cash Position of $516.5 Million Expected to Support Operating Plans at Least into 2029 SOUTH SAN FRANCISCO, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted pipeline progress and anticipated milestones and reported financial results for the second quarter ended June 30, 2026. “We continue to make meaningful progress across our portfolio as we execute on our strategy to develop differentiated oral medicines targeting GPCRs,” said Jeffrey Finer, M.D., Ph.D., Chief Executive Officer and Co-founder of Septerna. “We are advancing our Phase 1 study of SEP-479 and are very pleased with the observed clinical half-life, which is at the longer end of our preclinical estimates. This finding reinforces our confidence in the potential of SEP-479 as a differentiated, once-daily oral treatment for hypoparathyroidism, and we look forward to presenting SAD/MAD data in the first quarter of 2027. We are also advancing our broader portfolio by evaluating the next phase of development for SEP-631 in mast cell-driven diseases and progressing our TSHR program toward development candidate selection.” Recent Portfolio Progress and Anticipated Milestones SEP-479 PTH1R Agonist for Hypoparathyroidism: SEP-631 MRGPRX2 NAM for Mast Cell-Driven Diseases: TSHR NAM Program: Additional Programs: Second Quarter 2026 Financial Results Cash Position: Cash, cash equivalents, and marketable securities totaled $516.5 million as of June 30, 2026. Septerna expects its existing cash runway to fund operations at least into 2029. Revenue: Revenue from the Novo Nordisk collaboration was $26.7 million for the quarter ended June 30, 2026, compared to $0.1 million from Vertex for the quarter ended June 30, 2025. Revenue for the quarter ended June 30, 2026, included the amortization of $14.6 million of the $195.0 million upfront payment and $0.9 million from the achievement of $4.0 million in research milestones, in addition to $11.2 million for research services associated with the collaboration. R&D Expenses: Research and development (R&D) expenses were $35.1 million for the quarter ended June 30, 2026, compared to $22.2 million for the quarter ended June 30, 2025. G&A Expenses: General and administrative (G&A) expenses were $8.5 million for the quarter ended June 30, 2026, compared to $6.9 million for the quarter ended June 30, 2025. Net Loss: Net loss was $13.0 million for the quarter ended June 30, 2026, compared to $24.8 million for the quarter ended June 30, 2025. About SepternaSepterna, Inc. is a clinical-stage biotechnology company with a world-class team of GPCR experts and drug developers advancing cutting-edge science to unlock the full potential of GPCR therapies for patients with significant unmet needs. The company’s proprietary Native Complex Platform® is designed to enable new approaches to GPCR drug discovery and has led to the development of a diverse pipeline of novel oral small molecule drug candidates. Septerna is advancing programs in endocrinology, immunology and inflammation, metabolic diseases and additional therapeutic areas, both independently and with partners. For more information, please visit www.septerna.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Septerna’s beliefs and expectations regarding: the potential of SEP-479 preclinical data to translate into similar clinical safety, pharmacokinetic, and pharmacodynamic findings; the estimated availability of SEP-479 Phase 1 clinical data in the first quarter of 2027; the potential for SEP-479 to be a differentiated once-daily oral therapy for patients with hypoparathyroidism; the potential of its proprietary Native Complex Platform®; the continued advancement of SEP-631, including our plan to evaluate development strategies for capital-efficient, signal-finding clinical studies; the role of MRGPRX2 in mast cell-driven diseases; the potential of SEP-631 to provide a convenient oral treatment option for patients with mast cell-driven diseases; the ability of the SEP-631 Phase 1 safety and efficacy observations to successfully translate into clinical outcomes in patients; the continued development of its TSHR NAM program; the advancement of its discovery-stage programs across multiple therapeutic areas; the size and growth potential of the markets for its current and future product candidates; its expectations regarding strategic plans for its business, product candidates, and technology; its expectations regarding the Company’s uses of capital, expenses and financial results, including its expected cash runway at least into 2029; and the scope of protection it is able to establish and maintain for intellectual property rights covering its Native Complex Platform® and its product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: Septerna’s product candidates successfully entering and advancing through clinical trials (including those for SEP-479 and SEP-631) including uncertainties related to opening INDs and obtaining other regulatory approvals; risks related to clinical development outcomes including unexpected safety or efficacy findings; the results of preclinical studies including the long-term toxicology studies for SEP-479 and SEP-631, or clinical studies not being predictive of future clinical outcomes; risks related to the timing of initiating clinical studies and future availability of clinical data; the scope of protection Septerna is able to establish and maintain for intellectual property rights covering its Native Complex Platform® and its product candidates; and Septerna’s ability to identify and enter into future license agreements and collaborations; and general economic, industry and market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Septerna’s Quarterly Report on Form 10-Q for the three months ended June 30, 2026, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Septerna’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Septerna explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Investor Contact:Renee Leck, [email protected] Media Contact:Carly Scaduto, [email protected] Working capital is defined as total current assets less total current liabilities. See our financial statements and the related notes thereto included in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 for further details regarding our current assets and current liabilities.
Investor releaseQuarter not tagged2026-05-17Party Time: Brokers Just Made Major Increases To Their Septerna, Inc. (NASDAQ:SEPN) Earnings Forecasts
Simply Wall St.
Party Time: Brokers Just Made Major Increases To Their Septerna, Inc. (NASDAQ:SEPN) Earnings Forecasts
Septerna, Inc. (NASDAQ:SEPN) shareholders will have a reason to smile today, with the analysts making substantial upgrades to this year's forecasts. The analysts greatly increased their revenue estimates, suggesting a stark improvement in business fundamentals. Investors have been pretty optimistic on Septerna too, with the stock up 13% to US$26.95 over the past week. We'll be curious to see if these new estimates convince the market to lift the stock price higher still. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. After the upgrade, the nine analysts covering Septerna are now predicting revenues of US$83m in 2026. If met, this would reflect a notable 15% improvement in sales compared to the last 12 months. Per-share losses are expected to explode, reaching US$1.74 per share. However, before this estimates update, the consensus had been expecting revenues of US$66m and US$1.94 per share in losses. So there's been quite a change-up of views after the recent consensus updates, with the analysts making a sizeable increase to their revenue forecasts while also reducing the estimated loss as the business grows towards breakeven. See our latest analysis for Septerna These estimates are interesting, but it can be useful to paint some more broad strokes when seeing how forecasts compare, both to the Septerna's past performance and to peers in the same industry. It's pretty clear that there is an expectation that Septerna's revenue growth will slow down substantially, with revenues to the end of 2026 expected to display 21% growth on an annualised basis. This is compared to a historical growth rate of 7,296% over the past year. Juxtapose this against the other companies in the industry with analyst coverage, which are forecast to grow their revenues (in aggregate) 8.7% per year. So it's pretty clear that, while Septerna's revenue growth is expected to slow, it's still expected to grow faster than the industry itself. The highlight for us was that the consensus reduced its estimated losses this year, perhaps suggesting Septerna is moving incrementally towards profitability. They also upgraded their revenue estimates for this year, and sales are expected to grow faster than the wider market. More bullish expectations could be a signal for investors to take a closer look at Septerna. Even so, the long…Read full documentShow less
Septerna, Inc. (NASDAQ:SEPN) shareholders will have a reason to smile today, with the analysts making substantial upgrades to this year's forecasts. The analysts greatly increased their revenue estimates, suggesting a stark improvement in business fundamentals. Investors have been pretty optimistic on Septerna too, with the stock up 13% to US$26.95 over the past week. We'll be curious to see if these new estimates convince the market to lift the stock price higher still. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. After the upgrade, the nine analysts covering Septerna are now predicting revenues of US$83m in 2026. If met, this would reflect a notable 15% improvement in sales compared to the last 12 months. Per-share losses are expected to explode, reaching US$1.74 per share. However, before this estimates update, the consensus had been expecting revenues of US$66m and US$1.94 per share in losses. So there's been quite a change-up of views after the recent consensus updates, with the analysts making a sizeable increase to their revenue forecasts while also reducing the estimated loss as the business grows towards breakeven. See our latest analysis for Septerna These estimates are interesting, but it can be useful to paint some more broad strokes when seeing how forecasts compare, both to the Septerna's past performance and to peers in the same industry. It's pretty clear that there is an expectation that Septerna's revenue growth will slow down substantially, with revenues to the end of 2026 expected to display 21% growth on an annualised basis. This is compared to a historical growth rate of 7,296% over the past year. Juxtapose this against the other companies in the industry with analyst coverage, which are forecast to grow their revenues (in aggregate) 8.7% per year. So it's pretty clear that, while Septerna's revenue growth is expected to slow, it's still expected to grow faster than the industry itself. The highlight for us was that the consensus reduced its estimated losses this year, perhaps suggesting Septerna is moving incrementally towards profitability. They also upgraded their revenue estimates for this year, and sales are expected to grow faster than the wider market. More bullish expectations could be a signal for investors to take a closer look at Septerna. Even so, the longer term trajectory of the business is much more important for the value creation of shareholders. We have estimates - from multiple Septerna analysts - going out to 2028, and you can see them free on our platform here. Of course, seeing company management invest large sums of money in a stock can be just as useful as knowing whether analysts are upgrading their estimates. So you may also wish to search this free list of stocks with high insider ownership. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2026-05-15Earnings Update: Septerna, Inc. (NASDAQ:SEPN) Just Reported And Analysts Are Boosting Their Estimates
Simply Wall St.
Earnings Update: Septerna, Inc. (NASDAQ:SEPN) Just Reported And Analysts Are Boosting Their Estimates
Septerna, Inc. (NASDAQ:SEPN) defied analyst predictions to release its first-quarter results, which were ahead of market expectations. The results were impressive, with revenues of US$27m exceeding analyst forecasts by 76%, and statutory losses of US$0.19 were likewise much smaller than the analysts had forecast. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. We thought readers would find it interesting to see the analysts latest (statutory) post-earnings forecasts for next year. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Following the latest results, Septerna's nine analysts are now forecasting revenues of US$83.3m in 2026. This would be a meaningful 15% improvement in revenue compared to the last 12 months. Losses are forecast to balloon 118% to US$1.74 per share. Yet prior to the latest earnings, the analysts had been forecasting revenues of US$65.7m and losses of US$1.94 per share in 2026. So there's been quite a change-up of views after the recent consensus updates, with the analysts making a sizeable increase to their revenue forecasts while also reducing the estimated loss as the business grows towards breakeven. See our latest analysis for Septerna There was no major change to the consensus price target of US$44.25, perhaps suggesting that the analysts remain concerned about ongoing losses despite the improved earnings and revenue outlook. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. Currently, the most bullish analyst values Septerna at US$60.00 per share, while the most bearish prices it at US$35.00. Analysts definitely have varying views on the business, but the spread of estimates is not wide enough in our view to suggest that extreme outcomes could await Septerna shareholders. Looking at the bigger picture now, one of the ways we can make sense of these forecasts is to see how they measure up against both past performance and industry growth estimates. It's pretty clear that th…Read full documentShow less
Septerna, Inc. (NASDAQ:SEPN) defied analyst predictions to release its first-quarter results, which were ahead of market expectations. The results were impressive, with revenues of US$27m exceeding analyst forecasts by 76%, and statutory losses of US$0.19 were likewise much smaller than the analysts had forecast. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. We thought readers would find it interesting to see the analysts latest (statutory) post-earnings forecasts for next year. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Following the latest results, Septerna's nine analysts are now forecasting revenues of US$83.3m in 2026. This would be a meaningful 15% improvement in revenue compared to the last 12 months. Losses are forecast to balloon 118% to US$1.74 per share. Yet prior to the latest earnings, the analysts had been forecasting revenues of US$65.7m and losses of US$1.94 per share in 2026. So there's been quite a change-up of views after the recent consensus updates, with the analysts making a sizeable increase to their revenue forecasts while also reducing the estimated loss as the business grows towards breakeven. See our latest analysis for Septerna There was no major change to the consensus price target of US$44.25, perhaps suggesting that the analysts remain concerned about ongoing losses despite the improved earnings and revenue outlook. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. Currently, the most bullish analyst values Septerna at US$60.00 per share, while the most bearish prices it at US$35.00. Analysts definitely have varying views on the business, but the spread of estimates is not wide enough in our view to suggest that extreme outcomes could await Septerna shareholders. Looking at the bigger picture now, one of the ways we can make sense of these forecasts is to see how they measure up against both past performance and industry growth estimates. It's pretty clear that there is an expectation that Septerna's revenue growth will slow down substantially, with revenues to the end of 2026 expected to display 21% growth on an annualised basis. This is compared to a historical growth rate of 7,296% over the past year. Juxtapose this against the other companies in the industry with analyst coverage, which are forecast to grow their revenues (in aggregate) 8.0% per year. Even after the forecast slowdown in growth, it seems obvious that Septerna is also expected to grow faster than the wider industry. The most obvious conclusion is that the analysts made no changes to their forecasts for a loss next year. Pleasantly, they also upgraded their revenue estimates, and their forecasts suggest the business is expected to grow faster than the wider industry. There was no real change to the consensus price target, suggesting that the intrinsic value of the business has not undergone any major changes with the latest estimates. With that in mind, we wouldn't be too quick to come to a conclusion on Septerna. Long-term earnings power is much more important than next year's profits. At Simply Wall St, we have a full range of analyst estimates for Septerna going out to 2028, and you can see them free on our platform here.. However, before you get too enthused, we've discovered 2 warning signs for Septerna (1 is potentially serious!) that you should be aware of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2026-05-12Septerna Highlights Business Progress and Reports First Quarter 2026 Financial Results
GlobeNewswire
Septerna Highlights Business Progress and Reports First Quarter 2026 Financial Results
Compelling Phase 1 Data for SEP-631 (MRGPRX2 NAM) in Healthy Volunteers Support Phase 2b Development, Initially in Chronic Spontaneous Urticaria (CSU) in Second Half of 2026 Phase 1 Clinical Trial Initiated for SEP-479, Oral Small Molecule PTH1R Agonist for Hypoparathyroidism Cash Position of $522.1 Million Expected to Support Operating Plans at Least into 2029 SOUTH SAN FRANCISCO, Calif., May 11, 2026 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted pipeline progress and anticipated milestones and reported financial results for the first quarter ended March 31, 2026. “In the first quarter, we continued to make meaningful progress across our pipeline, highlighted by positive Phase 1 clinical results for SEP-631 and the initiation of our Phase 1 clinical trial for SEP-479,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “These advances further validate our Native Complex Platform® and its ability to efficiently generate differentiated oral small molecules against historically challenging GPCR targets. As our clinical programs continue to advance, we believe Septerna is increasingly well positioned to unlock the broad therapeutic potential of GPCR-targeted medicines for patients with significant unmet need.” Recent Portfolio Progress and Anticipated Milestones SEP-479 PTH1R Agonist for Hypoparathyroidism: In April 2026, Septerna initiated a Phase 1 clinical trial of SEP-479, its potent, selective oral small molecule PTH1R agonist for the treatment of hypoparathyroidism. The single-ascending dose and multiple-ascending dose study is evaluating safety, tolerability, pharmacokinetics and pharmacodynamics (including serum calcium and endogenous serum PTH) in healthy volunteers, with data expected in late 2026 or early 2027. SEP-631 MRGPRX2 NAM for Mast Cell-Driven Diseases: In March 2026, Septerna presented positive Phase 1 clinical results for SEP-631, its oral small molecule MRGPRX2 negative allosteric modulator (NAM), supporting advancement into Phase 2 development. SEP-631 was well tolerated, demonstrated a pharmacokinetic profile supportive of once-daily oral dosing and produced robust, dose-dependent suppression of icatibant-induced skin wheal formation. Septerna continues preparations to i…Read full documentShow less
Compelling Phase 1 Data for SEP-631 (MRGPRX2 NAM) in Healthy Volunteers Support Phase 2b Development, Initially in Chronic Spontaneous Urticaria (CSU) in Second Half of 2026 Phase 1 Clinical Trial Initiated for SEP-479, Oral Small Molecule PTH1R Agonist for Hypoparathyroidism Cash Position of $522.1 Million Expected to Support Operating Plans at Least into 2029 SOUTH SAN FRANCISCO, Calif., May 11, 2026 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted pipeline progress and anticipated milestones and reported financial results for the first quarter ended March 31, 2026. “In the first quarter, we continued to make meaningful progress across our pipeline, highlighted by positive Phase 1 clinical results for SEP-631 and the initiation of our Phase 1 clinical trial for SEP-479,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “These advances further validate our Native Complex Platform® and its ability to efficiently generate differentiated oral small molecules against historically challenging GPCR targets. As our clinical programs continue to advance, we believe Septerna is increasingly well positioned to unlock the broad therapeutic potential of GPCR-targeted medicines for patients with significant unmet need.” Recent Portfolio Progress and Anticipated Milestones SEP-479 PTH1R Agonist for Hypoparathyroidism: In April 2026, Septerna initiated a Phase 1 clinical trial of SEP-479, its potent, selective oral small molecule PTH1R agonist for the treatment of hypoparathyroidism. The single-ascending dose and multiple-ascending dose study is evaluating safety, tolerability, pharmacokinetics and pharmacodynamics (including serum calcium and endogenous serum PTH) in healthy volunteers, with data expected in late 2026 or early 2027. SEP-631 MRGPRX2 NAM for Mast Cell-Driven Diseases: In March 2026, Septerna presented positive Phase 1 clinical results for SEP-631, its oral small molecule MRGPRX2 negative allosteric modulator (NAM), supporting advancement into Phase 2 development. SEP-631 was well tolerated, demonstrated a pharmacokinetic profile supportive of once-daily oral dosing and produced robust, dose-dependent suppression of icatibant-induced skin wheal formation. Septerna continues preparations to initiate a Phase 2b trial of SEP-631 in chronic spontaneous urticaria (CSU) in the second half of 2026, following completion of long-term toxicology studies. The Company expects to subsequently evaluate SEP-631 in an open-label study in chronic inducible urticaria patients with symptomatic dermatographism. Septerna is also assessing additional mast cell-driven diseases characterized by high unmet need. TSHR NAM Program: Septerna continues to progress toward development candidate selection for its TSHR NAM program, with the goal of delivering a potential disease-modifying oral treatment for Graves’ disease and thyroid eye disease. Additional Programs: Septerna continues to advance and achieve research milestones from its global collaboration with Novo Nordisk to discover, develop and commercialize multiple potential oral small molecule medicines for obesity, type 2 diabetes and other cardiometabolic diseases based on specified GPCR targets. The Company also continues to advance wholly-owned discovery-stage programs utilizing its Native Complex Platform® across multiple therapeutic areas. Corporate Update Septerna’s Chief Medical Officer, Jae Kim, M.D., has informed the Company of his decision to pursue a new opportunity located in Southern California near his primary residence. Septerna has initiated a search for a successor, and Dr. Kim will continue to serve in an advisory capacity during the transition period. First Quarter 2026 Financial Results Cash Position: Cash, cash equivalents, and marketable securities totaled $522.1 million as of March 31, 2026. Septerna expects its existing cash runway to fund operations at least into 2029. Revenue: Revenue from the Novo Nordisk collaboration was $26.5 million for the quarter ended March 31, 2026, compared to $0.2 million from Vertex for the quarter ended March 31, 2025. Revenue for the quarter ended March 31, 2026, included the amortization of $15.7 million of the $195.0 million from the upfront payment and $0.5 million from the achievement of $2.0 million in research milestones in addition to $10.3 million for research services associated with the collaboration. R&D Expenses: Research and development (R&D) expenses were $29.5 million for the quarter ended March 31, 2026, compared to $19.3 million for the quarter ended March 31, 2025. G&A Expenses: General and administrative (G&A) expenses were $10.3 million for the quarter ended March 31, 2026, compared to $6.9 million for the quarter ended March 31, 2025. Net Loss: Net loss was $8.6 million for the quarter ended March 31, 2026, compared to $21.5 million for the quarter ended March 31, 2025. About Septerna Septerna, Inc. is a clinical-stage biotechnology company with a world-class team of GPCR experts and drug developers advancing cutting-edge science to unlock the full potential of GPCR therapies for patients with significant unmet needs. The company’s proprietary Native Complex Platform® is designed to enable new approaches to GPCR drug discovery and has led to the development of a diverse pipeline of novel oral small molecule drug candidates. Septerna is advancing programs in endocrinology, immunology and inflammation, metabolic diseases and additional therapeutic areas, both independently and with partners. For more information, please visit www.septerna.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Septerna’s beliefs and expectations regarding: the potential of SEP-479 preclinical data to translate into similar clinical safety, pharmacokinetic, and pharmacodynamic findings; the estimated availability of SEP-479 Phase 1 clinical data in late 2026 or early 2027; the potential for SEP-479 to be a differentiated once-daily oral therapy for patients with hypoparathyroidism; the potential of its proprietary Native Complex Platform®; the continued advancement of SEP-631, including the plan to initiate a Phase 2b clinical study in CSU in the second half of 2026 subject to the successful completion of long-term preclinical toxicology studies; the role of MRGPRX2 in mast cell-driven diseases; the potential of SEP-631 to provide a convenient oral treatment option for patients with CSU and other mast cell-driven diseases; expectations regarding the anticipated once-daily dosing frequency of SEP-631; the ability of the SEP-631 Phase 1 safety and efficacy observations to successfully translate into clinical outcomes in patients; the continued development of its TSHR NAM program; the advancement of its discovery-stage programs across multiple therapeutic areas; the size and growth potential of the markets for its current and future product candidates; its expectations regarding strategic plans for its business, product candidates, and technology; its expectations regarding the company’s uses of capital, expenses and financial results, including its expected cash runway at least into 2029; and the scope of protection it is able to establish and maintain for intellectual property rights covering its Native Complex Platform® and its product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: Septerna’s product candidates successfully entering and advancing through clinical trials (including those for SEP-479 and SEP-631) including uncertainties related to opening INDs and obtaining other regulatory approvals; risks related to clinical development outcomes including unexpected safety or efficacy findings; the results of preclinical studies including the long-term toxicology studies for SEP-479 and SEP-631, or clinical studies not being predictive of future clinical outcomes; risks related to the timing of initiating clinical studies and future availability of clinical data; the scope of protection Septerna is able to establish and maintain for intellectual property rights covering its Native Complex Platform® and its product candidates; and Septerna’s ability to identify and enter into future license agreements and collaborations; and general economic, industry and market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Septerna’s Annual Report on Form 10-K for the year ended December 31, 2025, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Septerna’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Septerna explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Investor Contact: Renee Leck, THRUST [email protected] Media Contact: Carly Scaduto, THRUST [email protected]
Investor releaseQuarter not tagged2026-05-11Liquidia Corporation (LQDA) Surpasses Q1 Earnings and Revenue Estimates
Zacks
Liquidia Corporation (LQDA) Surpasses Q1 Earnings and Revenue Estimates
Liquidia Corporation (LQDA) came out with quarterly earnings of $0.52 per share, beating the Zacks Consensus Estimate of $0.34 per share. This compares to a loss of $0.45 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +54.76%. A quarter ago, it was expected that this company would post earnings of $0.08 per share when it actually produced earnings of $0.15, delivering a surprise of +87.5%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Liquidia Corporation, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $132.87 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 22.11%. This compares to year-ago revenues of $3.12 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Liquidia Corporation shares have added about 22.6% since the beginning of the year versus the S&P 500's gain of 8.1%. While Liquidia Corporation has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Liquidia Corporation was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #1 (Strong Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see…Read full documentShow less
Liquidia Corporation (LQDA) came out with quarterly earnings of $0.52 per share, beating the Zacks Consensus Estimate of $0.34 per share. This compares to a loss of $0.45 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +54.76%. A quarter ago, it was expected that this company would post earnings of $0.08 per share when it actually produced earnings of $0.15, delivering a surprise of +87.5%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Liquidia Corporation, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $132.87 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 22.11%. This compares to year-ago revenues of $3.12 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Liquidia Corporation shares have added about 22.6% since the beginning of the year versus the S&P 500's gain of 8.1%. While Liquidia Corporation has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Liquidia Corporation was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #1 (Strong Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.35 on $110.17 million in revenues for the coming quarter and $1.75 on $477.39 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Septerna, Inc. (SEPN), has yet to report results for the quarter ended March 2026. This company is expected to post quarterly loss of $0.51 per share in its upcoming report, which represents a year-over-year change of -4.1%. The consensus EPS estimate for the quarter has been revised 30.5% lower over the last 30 days to the current level. Septerna, Inc.'s revenues are expected to be $19.95 million, up 8969.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Liquidia Corporation (LQDA) : Free Stock Analysis Report Septerna, Inc. (SEPN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-03-10Septerna Highlights Pipeline Progress and Reports Fourth Quarter and Full Year 2025 Financial Results
GlobeNewswire
Septerna Highlights Pipeline Progress and Reports Fourth Quarter and Full Year 2025 Financial Results
Compelling Phase 1 Data for SEP-631 (MRGPRX2 NAM) in Healthy Volunteers Support Phase 2b Development, Initially in Chronic Spontaneous Urticaria (CSU) in Second Half of 2026 Advancing SEP-479 (PTH1R Agonist) Toward Phase 1 Initiation in First Half of 2026 Cash Runway Expected to Support Operating Plans at Least into 2029 SOUTH SAN FRANCISCO, Calif., March 09, 2026 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted pipeline progress and anticipated milestones and reported financial results for the fourth quarter and full year ended December 31, 2025. "We made significant strides advancing our pipeline in the past year, and 2026 has already delivered a meaningful milestone with positive Phase 1 results for SEP-631,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “These results demonstrate clinical proof-of-mechanism and validate the ability of our Native Complex Platform® to uncover novel mechanisms of action and rapidly generate differentiated oral small molecules for historically challenging GPCRs. With SEP-479 approaching Phase 1 initiation in the coming months, SEP-631 poised for Phase 2 development in the second half of the year, and additional programs progressing behind them, we believe 2026 will be a year of strong progress for Septerna and for the patients we are committed to serving.” Recent Pipeline Progress and Anticipated Milestones SEP-631 MRGPRX2 NAM for Mast Cell Diseases: In March 2026, Septerna presented positive results from its Phase 1 clinical trial evaluating SEP-631, its potent, selective and insurmountable oral small molecule MRGPRX2 negative allosteric modulator (NAM) and outlined its initial Phase 2 development strategy. Key findings include: Safety: SEP-631 was well-tolerated at all doses studied with an adverse event profile comparable to placebo. Pharmacokinetics (PK): SEP-631 demonstrated a PK profile supportive of convenient once-daily oral dosing without food restrictions. Pharmacodynamics (PD): SEP-631 produced robust suppression of wheal formation across evaluated dose levels, with complete inhibition observed at doses as low as 10 mg once daily following the 10 µg/mL icatibant challenge. Following the 100 µg/mL icatibant challenge, inhibition was dose-dependen…Read full documentShow less
Compelling Phase 1 Data for SEP-631 (MRGPRX2 NAM) in Healthy Volunteers Support Phase 2b Development, Initially in Chronic Spontaneous Urticaria (CSU) in Second Half of 2026 Advancing SEP-479 (PTH1R Agonist) Toward Phase 1 Initiation in First Half of 2026 Cash Runway Expected to Support Operating Plans at Least into 2029 SOUTH SAN FRANCISCO, Calif., March 09, 2026 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted pipeline progress and anticipated milestones and reported financial results for the fourth quarter and full year ended December 31, 2025. "We made significant strides advancing our pipeline in the past year, and 2026 has already delivered a meaningful milestone with positive Phase 1 results for SEP-631,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “These results demonstrate clinical proof-of-mechanism and validate the ability of our Native Complex Platform® to uncover novel mechanisms of action and rapidly generate differentiated oral small molecules for historically challenging GPCRs. With SEP-479 approaching Phase 1 initiation in the coming months, SEP-631 poised for Phase 2 development in the second half of the year, and additional programs progressing behind them, we believe 2026 will be a year of strong progress for Septerna and for the patients we are committed to serving.” Recent Pipeline Progress and Anticipated Milestones SEP-631 MRGPRX2 NAM for Mast Cell Diseases: In March 2026, Septerna presented positive results from its Phase 1 clinical trial evaluating SEP-631, its potent, selective and insurmountable oral small molecule MRGPRX2 negative allosteric modulator (NAM) and outlined its initial Phase 2 development strategy. Key findings include: Safety: SEP-631 was well-tolerated at all doses studied with an adverse event profile comparable to placebo. Pharmacokinetics (PK): SEP-631 demonstrated a PK profile supportive of convenient once-daily oral dosing without food restrictions. Pharmacodynamics (PD): SEP-631 produced robust suppression of wheal formation across evaluated dose levels, with complete inhibition observed at doses as low as 10 mg once daily following the 10 µg/mL icatibant challenge. Following the 100 µg/mL icatibant challenge, inhibition was dose-dependent, with progressively greater suppression observed at increasing SEP-631 doses with near to complete inhibition achieved at 90 and 200 mg once daily. Septerna plans to initiate a Phase 2b trial of SEP-631 in CSU in the second half of 2026 following completion of long-term toxicology studies, with an open-label study in chronic inducible urticaria (CIndU) patients with symptomatic dermatographism to follow. Septerna is also evaluating additional mast cell-driven diseases with high unmet need and MRGPRX2 expression on tissue-resident mast cells. SEP-479 PTH1R Agonist for Hypoparathyroidism: Septerna has completed IND-enabling studies for SEP-479, its potent and selective oral small molecule PTH1R agonist, and is on track to initiate a Phase 1 clinical trial in the first half of 2026. TSHR NAM Program: Septerna continues to progress toward development candidate selection for its TSHR NAM program, with the goal of delivering a potential disease-modifying oral treatment for Graves’ disease and thyroid eye disease. Discovery Programs: Septerna also continues to advance discovery-stage programs utilizing its Native Complex Platform® across multiple therapeutic areas. Business Highlights In January 2026, Septerna appointed Mark A. Wilson as chief legal officer. Mr. Wilson is an accomplished pharmaceutical and biotech executive with more than 25 years of experience across intellectual property, corporate legal, strategic collaborations and corporate governance matters. Fourth Quarter and Full Year 2025 Financial Results Cash Position: Cash, cash equivalents, and marketable securities totaled $548.7 million as of December 31, 2025, compared to $420.8 million as of December 31, 2024. During 2025, Septerna received a $195.0 million upfront payment from Novo Nordisk and a $12.5 million milestone payment from Vertex. Septerna expects its existing cash runway to fund operations at least into 2029. Revenue: Revenue was $24.1 million for the fourth quarter of 2025 and $46.0 million for the full year ended December 31, 2025, compared to $0.2 million for the fourth quarter of 2024 and $1.1 million for the full year ended December 31, 2024. Revenue for the fourth quarter of 2025 included the amortization of $14.0 million of the $195.0 million upfront payment received from Novo Nordisk in July 2025, as well as $10.1 million for research services associated with the collaboration. Revenue for the full year ended December 31, 2025, included the amortization of $26.8 million of the $195.0 million upfront payment received from Novo Nordisk in July 2025, as well as $18.6 million for research services associated with the collaboration. R&D Expenses: Research and development (R&D) expenses were $31.9 million for the fourth quarter of 2025 and $97.6 million for the full year ended December 31, 2025, compared to $19.3 million for the fourth quarter of 2024 and $65.3 million for the full year ended December 31, 2024. G&A Expenses: General and administrative (G&A) expenses were $8.3 million for the fourth quarter of 2025 and $29.2 million for the full year ended December 31, 2025, compared to $5.6 million for the fourth quarter of 2024 and $16.6 million for the full year ended December 31, 2024. Net Loss: Net loss was $10.7 million for the fourth quarter of 2025 and $48.9 million for the full year ended December 31, 2025, compared to net losses of $20.7 million for the fourth quarter of 2024 and $71.8 million for the full year ended December 31, 2024. About Septerna Septerna, Inc. is a clinical-stage biotechnology company with a world-class team of GPCR experts and drug developers advancing cutting-edge science to unlock the full potential of GPCR therapies for patients with significant unmet needs. The company’s proprietary Native Complex Platform® is designed to enable new approaches to GPCR drug discovery and has led to the development of a diverse pipeline of novel oral small molecule drug candidates. Septerna is advancing programs in endocrinology, immunology and inflammation, metabolic diseases and additional therapeutic areas, both independently and with partners. For more information, please visit www.septerna.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Septerna’s beliefs and expectations regarding: the continued advancement of SEP-631, including the plan to initiate a Phase 2b clinical study in CSU in the second half of 2026 subject to the successful completion of long-term preclinical toxicology studies; the role of MRGPRX2 in mast cell-driven diseases; the potential of SEP-631 to provide a convenient oral treatment option for patients with CSU and other mast cell-driven diseases; expectations regarding the anticipated once-daily dosing frequency of SEP-631; the ability of the SEP-631 Phase 1 safety and efficacy observations to successfully translate into clinical outcomes in patients; the continued advancement of SEP-479, including the plan to initiate a Phase 1 clinical study in the first half of 2026; the continued development of its TSHR NAM program; the advancement of its discovery-stage programs across multiple therapeutic areas; the potential of its proprietary Native Complex Platform®; the size and growth potential of the markets for its current and future product candidates; its expectations regarding strategic plans for its business, product candidates, and technology; its expectations regarding the company’s uses of capital, expenses and financial results, including its expected cash runway at least into 2029; and the scope of protection it is able to establish and maintain for intellectual property rights covering its Native Complex Platform® and its product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: Septerna’s product candidates successfully entering and advancing through clinical trials (including those for SEP-631) including uncertainties related to opening INDs and obtaining other regulatory approvals; risks related to clinical development outcomes including unexpected safety or efficacy findings; the results of preclinical studies including the long-term toxicology studies for SEP-631, or clinical studies not being predictive of future clinical outcomes; risks related to the timing of initiating clinical studies and future availability of clinical data; the scope of protection Septerna is able to establish and maintain for intellectual property rights covering its Native Complex Platform® and its product candidates; and Septerna’s ability to identify and enter into future license agreements and collaborations; and general economic, industry and market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Septerna’s Annual Report on Form 10-K for the year ended December 31, 2025, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Septerna’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Septerna explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Investor Contact: Renee Leck, THRUST [email protected] Media Contact: Carly Scaduto, THRUST [email protected]
Investor releaseQuarter not tagged2025-11-10Septerna Highlights Company Progress and Reports Third Quarter 2025 Financial Results
GlobeNewswire
Septerna Highlights Company Progress and Reports Third Quarter 2025 Financial Results
SEP-479 Selected as Next-Generation Oral PTH1R Agonist Development Candidate SEP-631 (MRGPRX2 NAM) Phase 1 Clinical Trial in Healthy Volunteers Ongoing Robust Financial Position of $561.6 Million Expected to Support Operations at Least into 2029 SOUTH SAN FRANCISCO, Calif., Nov. 10, 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 highlighted key business updates and upcoming milestones and reported financial results for the quarter ended September 30, 2025. “In the third quarter, we made meaningful progress across our portfolio, highlighted by the selection of SEP-479 as our next-generation PTH1R agonist development candidate for hypoparathyroidism and the initiation of our Phase 1 clinical trial for SEP-631 which targets MRGPRX2 for mast cell-driven diseases,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “Both programs exemplify the power of our Native Complex Platform™ to generate differentiated oral small-molecule GPCR therapies with the potential to address serious diseases across a range of indications. With multiple milestones anticipated in the first half of 2026, we are executing with focus and momentum as we work to deliver meaningful therapies for patients.” Corporate Overview and Anticipated Milestones SEP-479 PTH1R Agonist for Hypoparathyroidism: In September, Septerna announced the selection of SEP-479 as its next-generation, oral PTH1R agonist development candidate. In a seven-day study in healthy cynomolgus monkeys, SEP-479 demonstrated robust, dose-dependent increases in serum calcium and decreases in endogenous parathyroid hormone levels. Based on preclinical studies from multiple species, SEP-479 is projected to have a human half-life supportive of once-daily dosing, aligned with the company’s goal of providing full-day calcium control for patients with hypoparathyroidism. Following the successful completion of the remaining preclinical development activities, Septerna plans to initiate a Phase 1 clinical trial for SEP-479 in the first half of 2026. SEP-631 MRGPRX2 NAM for Mast Cell Diseases: A Phase 1 clinical trial of SEP-631, an oral small-molecule MRGPRX2 negative allosteric modulator (NAM) for the treatment of mast cell diseases including chronic spontaneous urticaria, is…Read full documentShow less
SEP-479 Selected as Next-Generation Oral PTH1R Agonist Development Candidate SEP-631 (MRGPRX2 NAM) Phase 1 Clinical Trial in Healthy Volunteers Ongoing Robust Financial Position of $561.6 Million Expected to Support Operations at Least into 2029 SOUTH SAN FRANCISCO, Calif., Nov. 10, 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 highlighted key business updates and upcoming milestones and reported financial results for the quarter ended September 30, 2025. “In the third quarter, we made meaningful progress across our portfolio, highlighted by the selection of SEP-479 as our next-generation PTH1R agonist development candidate for hypoparathyroidism and the initiation of our Phase 1 clinical trial for SEP-631 which targets MRGPRX2 for mast cell-driven diseases,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “Both programs exemplify the power of our Native Complex Platform™ to generate differentiated oral small-molecule GPCR therapies with the potential to address serious diseases across a range of indications. With multiple milestones anticipated in the first half of 2026, we are executing with focus and momentum as we work to deliver meaningful therapies for patients.” Corporate Overview and Anticipated Milestones SEP-479 PTH1R Agonist for Hypoparathyroidism: In September, Septerna announced the selection of SEP-479 as its next-generation, oral PTH1R agonist development candidate. In a seven-day study in healthy cynomolgus monkeys, SEP-479 demonstrated robust, dose-dependent increases in serum calcium and decreases in endogenous parathyroid hormone levels. Based on preclinical studies from multiple species, SEP-479 is projected to have a human half-life supportive of once-daily dosing, aligned with the company’s goal of providing full-day calcium control for patients with hypoparathyroidism. Following the successful completion of the remaining preclinical development activities, Septerna plans to initiate a Phase 1 clinical trial for SEP-479 in the first half of 2026. SEP-631 MRGPRX2 NAM for Mast Cell Diseases: A Phase 1 clinical trial of SEP-631, an oral small-molecule MRGPRX2 negative allosteric modulator (NAM) for the treatment of mast cell diseases including chronic spontaneous urticaria, is ongoing in healthy volunteers. The study is evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics (through an icatibant skin challenge), with initial single-ascending-dose and multiple-ascending-dose data expected in the first half of 2026. TSHR NAM Program: Septerna continues to make progress toward the selection of a development candidate for its TSHR NAM program, with the goal of delivering a potential disease-modifying oral treatment for Graves’ disease and thyroid eye disease. Discovery Programs: The company also continues to advance discovery-stage programs utilizing its Native Complex Platform™ across multiple therapeutic areas. Business Highlights In July, Septerna’s global collaboration and license agreement with Novo Nordisk formally commenced, with joint research and development activities underway to discover and develop oral small-molecule therapies for obesity, type 2 diabetes, and other cardiometabolic diseases. In September, Septerna appointed Keith Gottesdiener, M.D., to its Board of Directors, where he will serve as chairperson of the newly formed R&D Committee. Dr. Gottesdiener brings more than 30 years of experience advancing medicines from discovery through commercialization, including leadership roles at Prime Medicine, Rhythm Pharmaceuticals, and Merck Research Laboratories. His appointment further strengthens Septerna’s scientific and strategic leadership as the company advances its pipeline of potential GPCR-targeted therapies. Third Quarter 2025 Financial Results Cash Position: Cash, cash equivalents, and marketable securities totaled $561.6 million as of September 30, 2025, reflecting receipt of the $195.0 million upfront payment from Novo Nordisk and a $12.5 million milestone payment from Vertex. Septerna expects its existing cash runway to fund operations into at least 2029. Revenue: Revenue was $21.5 million for the quarter ended September 30, 2025, compared to $0.2 million for the quarter ended September 30, 2024. For the quarter ended September 30, 2025, revenue included the amortization of $12.8 million of the $195.0 million upfront payment received from Novo Nordisk in July 2025, as well as $8.5 million for research services associated with the Novo Nordisk collaboration. R&D Expenses: Research and development (R&D) expenses were $24.3 million for the quarter ended September 30, 2025, compared to $17.8 million for the quarter ended September 30, 2024. G&A Expenses: General and administrative (G&A) expenses were $7.1 million for the quarter ended September 30, 2025, compared to $4.9 million for the quarter ended September 30, 2024. Net Income (Loss): Net income was $8.2 million for the quarter ended September 30, 2025, compared to $20.5 million in net loss for the quarter ended September 30, 2024. About Septerna Septerna, Inc. is a clinical-stage biotechnology company with a world-class team of GPCR experts and drug developers advancing cutting-edge science to unlock the full potential of GPCR therapies for patients with significant unmet needs. The company’s proprietary Native Complex Platform™ is designed to enable new approaches to GPCR drug discovery and has led to the development of a diverse pipeline of novel oral small molecule drug candidates. Septerna is advancing programs in endocrinology, immunology and inflammation, metabolic diseases and additional therapeutic areas, both independently and with partners. For more information, please visit www.septerna.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Septerna’s beliefs and expectations regarding: the continued advancement of Septerna’s PTH1R agonist program, including the planned initiation of a Phase 1 clinical trial for SEP-479 in the first half of 2026, subject to successful completion of preclinical activities and regulatory submissions; the continued development and advancement of SEP-631, including the ongoing Phase 1 clinical trial and timing of initial data expected in the first half of 2026 for the Phase 1 single-ascending-dose and multiple-ascending-dose cohorts; its ability to demonstrate, and the timing of, preclinical proof-of-concept in vivo and ex vivo for multiple programs; its ability to advance any product candidates that it may identify and successfully complete any clinical studies; the initiation, timing, progress, and results of conducting its research and development programs, including its plans to advance multiple lead TSHR NAM program compounds toward development candidate selection; the potential of its proprietary Native Complex Platform™; the collaboration with Novo Nordisk, including its to jointly discover, develop and commercialize multiple potential oral small molecule therapies for obesity, type 2 diabetes, and other cardiometabolic diseases; its expectations regarding the implementation of its business model, strategic plans for its business, product candidates, and technology; and the accuracy of its estimates regarding expenses and capital requirements, including its expected cash runway at least into 2029. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: Septerna’s product candidates successfully entering and advancing through clinical trials (including SEP-479 and SEP-631); the authorization, initiation, and successful completion of preclinical and Investigational New Drug (IND)-enabling studies to support future clinical development of potential product candidates (including those for SEP-479), including uncertainties related to opening INDs and other regulatory approvals; risks related to clinical development outcomes including unexpected safety or efficacy findings; the results of preclinical studies, or clinical studies not being predictive of future clinical outcomes; risks related to the timing of initiating clinical studies and future availability of clinical data; the scope of protection Septerna is able to establish and maintain for intellectual property rights covering its Native Complex Platform™ and its product candidates; Septerna’s ability to maintain existing collaborations, identify and enter into future license agreements and collaborations, and realize the intended and potential benefits thereof; unanticipated future expense levels and capital requirements; and general economic, industry and market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Septerna’s Annual Report on Form 10-K for the year ended December 31, 2024, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Septerna’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Septerna explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Investor Contact: Renee Leck, THRUST [email protected] Media Contact: Carly Scaduto [email protected]
Investor releaseQuarter not tagged2025-11-10Septerna Swings to Q3 Earnings, Revenue Rises
MT Newswires
Septerna Swings to Q3 Earnings, Revenue Rises
Septerna (SEPN) reported Q3 net income Monday of $0.18 per diluted share, swinging from a loss of $8
Investor releaseQuarter not tagged2025-10-02LEXX: Biodistribution Study Results
Zacks Small Cap Research
LEXX: Biodistribution Study Results
By John Vandermosten, CFA NASDAQ:LEXX READ THE FULL LEXX RESEARCH REPORT As we step into fall, Lexaria Bioscience Corporation (NASDAQ:LEXX) continues to work on multiple GLP-1 trials. Most notably, it reported the last patient-last visit for the Phase Ib study designated GLP-1-H24-4 and reported data from its rodent biodistribution study. It also closed a $4.0 million capital raise earlier this week. Activity in the obesity and GLP-1 agonist space has been robust in 2025 with a number of deals and new trial data announced. In this report we will bring investors up to date on recent activity and update near term milestones. Lexaria View on GLP-1 Agonists In the fall of 2023, Lexaria began its efforts to evaluate members of the GLP-1 agonist class formulated with DehydraTECH to determine if the new formulation could improve bioavailability, cost-effectiveness, tolerability, weight-loss potential, management of diabetes and other health conditions. Since then, the company has launched five human studies along with other non-human work to answer this question. Over the last two years, Lexaria has reported the data from these trials showing reduced levels of side effects, comparable levels of glucose reduction and insulin increase, less semaglutide necessary than in Rybelsus to achieve similar effects. In an August 6th press release, management penned a missive reviewing GLP-1 agonist market activity highlighting the primary players (Eli Lilly and Novo Nordisk), the number of drugs in development (39) and number of sponsors advancing them (34). The note from management also addressed the dealmaking environment around the class, underlining the collaboration between Novo Nordisk and Septerna, Roche’s asset acquisition from Zealand Pharma, Regeneron’s licensing deal with Hansoh Pharmaceuticals and Merck and Cyprumed, which we discussed in our previous report. In late August, Eli Lilly announced data from its Phase III trial evaluating its oral GLP-1 receptor agonist, orforglipron. The study met all of its primary and secondary endpoints. With the completion of the study, Lilly has all the clinical data necessary to submit orforglipron for approval globally. Availability of an oral for Eli Lilly could raise the stakes for having an oral version of this class of drug and benefit Lexaria as others find other oral solutions for GLP-1 agonist delivery. Lexaria’s data co…Read full documentShow less
By John Vandermosten, CFA NASDAQ:LEXX READ THE FULL LEXX RESEARCH REPORT As we step into fall, Lexaria Bioscience Corporation (NASDAQ:LEXX) continues to work on multiple GLP-1 trials. Most notably, it reported the last patient-last visit for the Phase Ib study designated GLP-1-H24-4 and reported data from its rodent biodistribution study. It also closed a $4.0 million capital raise earlier this week. Activity in the obesity and GLP-1 agonist space has been robust in 2025 with a number of deals and new trial data announced. In this report we will bring investors up to date on recent activity and update near term milestones. Lexaria View on GLP-1 Agonists In the fall of 2023, Lexaria began its efforts to evaluate members of the GLP-1 agonist class formulated with DehydraTECH to determine if the new formulation could improve bioavailability, cost-effectiveness, tolerability, weight-loss potential, management of diabetes and other health conditions. Since then, the company has launched five human studies along with other non-human work to answer this question. Over the last two years, Lexaria has reported the data from these trials showing reduced levels of side effects, comparable levels of glucose reduction and insulin increase, less semaglutide necessary than in Rybelsus to achieve similar effects. In an August 6th press release, management penned a missive reviewing GLP-1 agonist market activity highlighting the primary players (Eli Lilly and Novo Nordisk), the number of drugs in development (39) and number of sponsors advancing them (34). The note from management also addressed the dealmaking environment around the class, underlining the collaboration between Novo Nordisk and Septerna, Roche’s asset acquisition from Zealand Pharma, Regeneron’s licensing deal with Hansoh Pharmaceuticals and Merck and Cyprumed, which we discussed in our previous report. In late August, Eli Lilly announced data from its Phase III trial evaluating its oral GLP-1 receptor agonist, orforglipron. The study met all of its primary and secondary endpoints. With the completion of the study, Lilly has all the clinical data necessary to submit orforglipron for approval globally. Availability of an oral for Eli Lilly could raise the stakes for having an oral version of this class of drug and benefit Lexaria as others find other oral solutions for GLP-1 agonist delivery. Lexaria’s data comparing Rybelsus, tirzepatide, semaglutide and liraglutide with DHT-formulated versions of these compounds now spans five human studies. With this trove of supportive information, the company seeks the interest of a major player in the industry who recognizes the value of an oral version of these injectable drugs. GLP-1 Agonist Rodent Biodistribution Study In November 2024, Lexaria announced that it had signed a contract for a GLP-1 agonist biodistribution study with an unidentified contract research organization. The research fluorescently tagged DHT formulated semaglutide and tracked its biodistribution in rodents. Understanding the distribution of the drug in subject tissue will help researchers understand the binding properties and receptors that are targeted by the drug. It can also help understand in which areas or tissues the drug concentrates and potentially lead to unwanted side effects. The work will also help researchers understand how orally delivered DHT-semaglutide differs from the infused formulation of the drug. Last month, Lexaria announced results from this study in a press release. Study Design Details were tracked via fluorescent imaging detection to show how and where the semaglutide distributes and localizes following oral ingestion by Sprague-Dawley rats. After the initial evaluation, the animals were euthanized and various key tissues were examined including those from the brain, pancreas, lung, kidney, liver and heart for more detailed fluorescent imaging detection showing very specific tissue localization patterns and concentrations. The analysis includes DHT and non-DHT formulated Rybelsus orally administered product. Efforts also included measurement of certain GLP-1 receptor specific antibodies detectable through an immunofluorescence methodology. This was done to allow the analytical laboratory to confirm the extent of GLP-1 receptor binding of the two formulations in the tissue samples taken from the animals, providing a detailed measure of fluorescence distribution and localization patterns. The fluorescent tagging of the two variations of semaglutide (Rybelsus and the DHT formulation) will show the biodistribution differences between the two. Study Results A September 19th press release shared results from the study. It noted that DHT-fluorescently tagged semaglutide (FTS) demonstrated a predominantly higher apparent trend in brain biodistribution than the Rybelsus equivalent composition and all study controls. The determination was made based on fluorescent signal intensity using whole brain imaging. Below, the DHT performance can be seen in the middle light blue, aqua and turquoise bars in the center of the exhibit. Following the whole-organ imaging of the rat model, the brain was further sectioned via sagittal slices (2-3 mm thickness) into two and then four pieces to better visualize the brain regions in which semaglutide is binding and stimulating a response. These regions of interest include the brainstem, known for direct semaglutide interaction; the paraventricular nucleus of the hypothalamus, involved in energy homeostasis; and the circumventricular organs, which lack a blood-brain barrier, such as the area postrema, subfornical organ and median eminence. Upon measurement, investigators noted that all three DHT doses tested displayed fluorescence above that of the naïve and vehicle groups, while only the highest dosage (15mg/kg) of the Rybelsus equivalent composition surpassed the naïve and vehicle groups. Lexaria believes that findings from the study suggest that the DHT-FTS composition, absent all of the Rybelsus composition excipients, may enable unique delivery and distribution enhancements in brain tissue possibly supporting improved pharmacodynamic performance. Complementary biodistribution benefits may be derived by using a similar DehydraTECH semaglutide composition combined with the Rybelsus excipients. Future testing to show this would be required to measure this and potential safety and efficacy improvements. This type of study helps researchers further understand the pharmacokinetics and mechanism of action of DHT-formulated semaglutide and will be part of the conversations with large pharma partners. GLP-1-H24-4 Interim Results (Fourth Study) At the end of July, Lexaria provided an interim look into its GLP-1-H24-4 study highlighting the reduction in side effects for the DHT formulated GLP-1s vs. approved versions of the drug. At eight weeks, the DHT-semaglutide arm saw a 36.5% reduction in overall side effects and 43.5% lower gastrointestinal (GI) side effects compared to results in the Rybelsus arm. Our report reviewing 3Q:25 results provided a summary of adverse events from the trial. Lexaria’s press release documented at least one adverse event (AE) for each of the 25 subjects in the Rybelsus arm. Five subjects in the DHT arm (5/24) experienced no AEs (referenced as a 20.8% reduction in Lexaria’s press release). A study cited by Lexaria (Bergmann, et al. 2022) found just under 90% of semaglutide patients in the study experienced an AE. The press release compares this to DHT-semaglutide’s AE rate of 79.2%. However, the comparison must be placed in the context of the Lexaria data at the 8-week mark and including 24 people compared to the greater than 1,000 subjects assessed for injected semaglutide. Lexaria reviewed several tirzepatide studies and found a similar incidence of AEs as they did for semaglutide in a meta-analysis (Mishra et al. 2023). The study noted a positive correlation between dose level and incidence of AEs. Another remarkable takeaway from the meta-analysis is the high rate of GI-related AEs which comprised up to 50% of the total AEs for injectable tirzepatide. Lexaria compared this hurdle to the 22% rate achieved with DHT-semaglutide in the 8-week study. GLP-1-H24-4 was conducted with 24-25 overweight, obese, pre- or type 2 diabetic patients in each of the five study arms (n=126), of which 4 arms evaluated various DehydraTECH formulations with the 5th being the Study control arm. Arm 1 evaluated DHT-CBD, Arm 2, DHT-semaglutide and Arm 3, DHT-semaglutide and DHT-CBD. Arm 4 evaluated Rybelsus tablets and Arm 5 examined DHT-tirzepatide. Changes in glycated hemoglobin (HbA1c) and weight were other measured endpoints in the GLP-1-H24-4 study. Lexaria extracted these same metrics from Novo Nordisk’s Pioneer studies[2],[3]. DHT-semaglutide was able to reduce HbA1c and weight over the eight weeks, but at a lesser magnitude than what was achieved by Rybelsus. While DHT-semaglutide achieved lower levels of weight loss and HbA1c reduction compared to Rybelsus, it also is associated with reduced side effects, especially those that are GI-related. We think that 8-week data is insufficient for making significant comparisons. The primary takeaways are that the trend in endpoints is moving in the right direction and that reduced adverse events will allow for a greater number of patients to continue on a therapy so they can obtain its benefit. Lexaria also brought attention to the focus on adverse events with a quote[4] from Martin Hoist Lange, who was promoted to Chief Scientific Officer of Novo Nordisk earlier this week: “We want to win the weight loss [battle] but we also want to have a gastrointestinal adverse event profile that is attractive and competitive.” On August 14th, 2025 Lexaria announced that the last patient-last visit had been completed. Study work accelerates with full sample and data analyses underway with the goal of reporting data prior to the end of 2025. The company’s CRO is managing the laboratory analysis phase of the work and management is blinded until the work has been completed. $4.0 Million Offering On September 26th, Lexaria announced a $4.0 million registered direct offering priced at the market. 2,666,667 shares of Lexaria common stock were offered at $1.50 per share along with the same number of warrants with a $1.37 exercise price. Gross proceeds are estimated to be approximately $4.0 million and we forecast net proceeds to be about $3.6 million after deducting the placement agent fees and other offering expenses. The offering closed on September 29th. Pipeline SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE. ________________________ [1] Total radiant efficiency (TRE) is a measure of the summation of flux (i.e., measured fluorescence) within a given tissue region of interest (ROI). For the brain analyses in this study, an ROI was drawn around the excised brain tissue samples to quantify the total fluorescence within that region in each case. To account for the variability in ROI size, the TRE was divided by the area of the ROI to "normalize" the value. In short, Normalized TRE = TRE/ROI area. [2] Aroda, V.R. et al. A new era for oral peptides: SNAC and the development of oral semaglutide for the treatment of type 2 diabetes. Reviews in Endocrine and Metabolic Disorders. October 2022. [3] Husain, M. et al. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. New England Journal of Medicine. June 2019. [4] Novo Nordisk R&D Investor Event, June 22, 2025
Investor releaseQuarter not tagged2025-08-13Septerna Second Quarter 2025 Earnings: Misses Expectations
Simply Wall St.
Septerna Second Quarter 2025 Earnings: Misses Expectations
Explore Septerna's Fair Values from the Community and select yours Net loss: US$24.8m (loss widened by 51% from 2Q 2024). US$0.56 loss per share. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 100%. Earnings per share (EPS) was also behind analyst expectations. Looking ahead, revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Pharmaceuticals industry in the US. Performance of the American Pharmaceuticals industry. The company's shares are down 3.9% from a week ago. What about risks? Every company has them, and we've spotted 4 warning signs for Septerna (of which 2 make us uncomfortable!) you should know about. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-08-12Septerna Highlights Business Progress and Reports Second Quarter 2025 Financial Results
GlobeNewswire
Septerna Highlights Business Progress and Reports Second Quarter 2025 Financial Results
Advancing Selection of Next-Generation Oral Small Molecule PTH1R Agonist for Clinical Development Initiating Phase 1 Trial for SEP-631, MRGPRX2 NAM Program, for Mast Cell Diseases Updated Cash Runway Expected to Support Operating Plans at Least into 2029 SOUTH SAN FRANCISCO, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted key business updates and upcoming milestones and reported financial results for the second quarter ended June 30, 2025. "We are executing effectively across our portfolio, with each program nearing important milestones," said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. "Our next-generation PTH1R agonist program for hypoparathyroidism is progressing through preclinical studies as we work toward selecting a development candidate in the third quarter with plans to start a Phase 1 clinical trial in the first half of 2026. In the near term, we are excited to initiate first-in-human studies for SEP-631, our oral small molecule in development for mast cell-driven diseases. With our robust financial position, bolstered by our collaboration with Novo Nordisk which became effective in July, and our strong R&D capabilities, we believe we are well positioned to pursue multiple programs towards our goal of delivering innovative oral small molecule therapies that can meaningfully improve patient outcomes." Corporate Overview and Anticipated Milestones PTH1R Agonist Program: Septerna continues to advance its oral small molecule parathyroid hormone 1 receptor (PTH1R) agonist program with the goal of providing full-day calcium control in hypoparathyroidism patients. The company is tracking towards the selection of a next-generation PTH1R agonist development candidate in the third quarter of 2025 and plans to provide an update later this quarter. Following the successful completion of preclinical development activities, the company plans to commence a Phase 1 clinical trial in the first half of 2026. SEP-631 MRGPRX2 NAM Program: Septerna is initiating a Phase 1 clinical trial of SEP-631 to assess safety, tolerability, pharmacokinetics and pharmacodynamics (through an icatibant skin challenge) in healthy volunteers in the third quarter of 2025. SEP-631 is a selective oral small molecul…Read full documentShow less
Advancing Selection of Next-Generation Oral Small Molecule PTH1R Agonist for Clinical Development Initiating Phase 1 Trial for SEP-631, MRGPRX2 NAM Program, for Mast Cell Diseases Updated Cash Runway Expected to Support Operating Plans at Least into 2029 SOUTH SAN FRANCISCO, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted key business updates and upcoming milestones and reported financial results for the second quarter ended June 30, 2025. "We are executing effectively across our portfolio, with each program nearing important milestones," said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. "Our next-generation PTH1R agonist program for hypoparathyroidism is progressing through preclinical studies as we work toward selecting a development candidate in the third quarter with plans to start a Phase 1 clinical trial in the first half of 2026. In the near term, we are excited to initiate first-in-human studies for SEP-631, our oral small molecule in development for mast cell-driven diseases. With our robust financial position, bolstered by our collaboration with Novo Nordisk which became effective in July, and our strong R&D capabilities, we believe we are well positioned to pursue multiple programs towards our goal of delivering innovative oral small molecule therapies that can meaningfully improve patient outcomes." Corporate Overview and Anticipated Milestones PTH1R Agonist Program: Septerna continues to advance its oral small molecule parathyroid hormone 1 receptor (PTH1R) agonist program with the goal of providing full-day calcium control in hypoparathyroidism patients. The company is tracking towards the selection of a next-generation PTH1R agonist development candidate in the third quarter of 2025 and plans to provide an update later this quarter. Following the successful completion of preclinical development activities, the company plans to commence a Phase 1 clinical trial in the first half of 2026. SEP-631 MRGPRX2 NAM Program: Septerna is initiating a Phase 1 clinical trial of SEP-631 to assess safety, tolerability, pharmacokinetics and pharmacodynamics (through an icatibant skin challenge) in healthy volunteers in the third quarter of 2025. SEP-631 is a selective oral small molecule MRGPRX2 negative allosteric modulator (NAM) in development for the treatment of mast cell diseases, including chronic spontaneous urticaria. TSHR NAM Program: Septerna continues to make progress on its TSHR NAM program, moving multiple lead compounds closer to development candidate selection with the goal of delivering a potential disease-modifying oral treatment for Graves’ disease and thyroid eye disease. Discovery Programs: Septerna continues to advance discovery-stage programs utilizing its Native Complex Platform™ across multiple therapeutic areas. Collaboration Agreement with Novo Nordisk On July 1, 2025, the previously announced global collaboration and license agreement between Septerna and Novo Nordisk became effective, initiating joint research and development efforts to discover, develop, and commercialize multiple potential oral small molecule therapies for obesity, type 2 diabetes, and other cardiometabolic diseases based on certain specified molecular targets. In connection with the effectiveness of the global collaboration and license agreement, Septerna received the $195 million upfront payment in July 2025. Septerna expects to recognize revenue for this upfront payment over the anticipated duration of the company’s participation in the research and development programs. More details about the global collaboration and license agreement can be found in the company’s press release and Current Report on Form 8-K filed on May 14, 2025. Business Highlights Septerna announced the promotion of Chief Operating Officer (COO) Liz Bhatt, MS, MBA, to President, effective August 1, 2025. Ms. Bhatt joined Septerna in 2022 as COO, bringing more than 30 years of strategy, deal-making and company-building experience across a range of biotech and pharmaceutical companies to the company. In her role, Ms. Bhatt will continue to have oversight of business development, alliance management, portfolio strategy, commercialization and information technology. “Liz has been an exceptional leader at Septerna from day one, playing a pivotal role in driving the growth of both our company and our pipeline,” added Dr. Finer. “Among many accomplishments, her leadership was instrumental in securing our multi-billion-dollar strategic partnership with Novo Nordisk, guiding Septerna through a successful upsized and oversubscribed IPO in 2024, and building out key functions across the business. On behalf of the entire organization and the Board, I want to congratulate Liz on this well-earned promotion.” Second Quarter 2025 Financial Results Cash Position: 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. R&D Expenses: Research and development (R&D) expenses were $22.2 million for the quarter ended June 30, 2025, compared to $15.0 million for the quarter ended June 30, 2024. G&A Expenses: General and administrative (G&A) expenses were $6.9 million for the quarter ended June 30, 2025, compared to $3.4 million for the quarter ended June 30, 2024. Net Loss: Net loss was $24.8 million for the quarter ended June 30, 2025, compared to $16.4 million for the quarter ended June 30, 2024. About Septerna Septerna, Inc. is a biotechnology company pioneering a new era of GPCR drug discovery powered by its proprietary Native Complex Platform™. Its industrial-scale platform aims to unlock the full potential of GPCR therapies and has led to the discovery and development of its deep pipeline of oral small molecule product candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases. Septerna was launched by preeminent drug discovery company builders and scientific leaders in the biochemistry, structural biology, and pharmacology of GPCRs. For more information, please visit www.septerna.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Septerna’s beliefs and expectations regarding: the continued advancement of Septerna’s PTH1R agonist program, including the anticipated timing for the selection of a next-generation PTH1R agonist development candidate in the third quarter of 2025 and the planned initiation of a Phase 1 clinical trial in the first half of 2026, subject to successful completion of preclinical activities; the continued development and advancement of its oral small molecule GPCR-targeted programs, including its expectations regarding the Phase 1 clinical trial initiation of SEP-631 in the third quarter of 2025; its ability to demonstrate, and the timing of, preclinical proof-of-concept in vivo and ex vivo for multiple programs; its ability to advance any product candidates that it may identify and successfully complete any clinical studies; the initiation, timing, progress, and results of conducting its research and development programs, including its plans to advance multiple lead TSHR NAM program compounds toward development candidate selection; the potential of its proprietary Native Complex Platform™; the intended and potential benefits of the collaboration with Novo Nordisk, including its ability to jointly discover, develop and commercialize multiple potential oral small molecule therapies for obesity, type 2 diabetes, and other cardiometabolic diseases; its expectations regarding the implementation of its business model, strategic plans for its business, product candidates, and technology, and the accuracy of its estimates regarding expenses and capital requirements, including its expected cash runway at least into 2029. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: uncertainties related to achieving the future potential research, development, and commercial milestones under the Novo Nordisk collaboration; uncertainties related to Septerna’s product candidates entering clinical trials; the authorization, initiation, and successful completion of preclinical and Investigational New Drug (IND)-enabling studies to support future clinical development of potential product candidates (including those for the PTH1R program), including uncertainties related to opening INDs and obtaining regulatory approvals; risks related to clinical development outcomes including unexpected safety or efficacy findings; the results of preclinical studies, or clinical studies not being predictive of future results in connection with future studies; the scope of protection Septerna is able to establish and maintain for intellectual property rights covering its Native Complex Platform™ and its product candidates; Septerna’s ability to identify and enter into future license agreements and collaborations; and general economic, industry and market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Septerna’s Annual Report on Form 10-K for the year ended December 31, 2024, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Septerna’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Septerna explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Investor Contact: Renee Leck, THRUST [email protected] Media Contact: Carly Scaduto [email protected]
Investor releaseQuarter not tagged2025-05-16Septerna Highlights Business Progress and Reports First Quarter 2025 Financial Results
GlobeNewswire
Septerna Highlights Business Progress and Reports First Quarter 2025 Financial Results
Announced Global Collaboration with Novo Nordisk to Develop Oral Small Molecules for Metabolic Diseases with Over $2.2 Billion in Potential Milestone Payments On Track to Select a Next-Generation Oral Small Molecule PTH1R Agonist to Accelerate Toward the Clinic Later in 2025 Expect to Initiate Phase 1 Trial for SEP-631, MRGPRX2 NAM Program for Mast Cell Diseases, in Third Quarter of 2025 Ended First Quarter 2025 with $398.2 Million in Cash, Cash Equivalents and Marketable Securities; Novo Nordisk Collaboration to Significantly Extend Prior Runway Guidance of Early 2028 SOUTH SAN FRANCISCO, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted key business updates and upcoming milestones and reported financial results for the first quarter ended March 31, 2025. “Yesterday’s landmark partnership announcement with Novo Nordisk to advance our incretin programs is an important validation of our GPCR Native Complex Platform™ and its potential to address major unmet needs in metabolic disease,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “This collaboration provides a significant opportunity to create multiple potentially groundbreaking oral medicines, while also providing Septerna with substantial resources and operational flexibility to advance our diverse portfolio. In parallel, we continue to advance our wholly owned pipeline, including our next-generation oral small molecule PTH1R agonist for hypoparathyroidism, where we remain on track to select a development candidate to advance toward the clinic later this year. Additionally, our SEP-631 program targeting mast cell diseases is progressing well, with clinical trial initiation expected in the third quarter of this year. With a strong balance sheet, a differentiated technology platform, and a clear focus on execution, we believe we are well positioned to create long-term value for patients and shareholders.” Corporate Overview and Anticipated Milestones PTH1R Agonist Program: Septerna continues to advance multiple lead compounds with distinct chemical structures unrelated to its first-generation oral small molecule, SEP-786, each with favorable pharmacokinetics (PK) profiles that support the potential for full-day calcium control in hypop…Read full documentShow less
Announced Global Collaboration with Novo Nordisk to Develop Oral Small Molecules for Metabolic Diseases with Over $2.2 Billion in Potential Milestone Payments On Track to Select a Next-Generation Oral Small Molecule PTH1R Agonist to Accelerate Toward the Clinic Later in 2025 Expect to Initiate Phase 1 Trial for SEP-631, MRGPRX2 NAM Program for Mast Cell Diseases, in Third Quarter of 2025 Ended First Quarter 2025 with $398.2 Million in Cash, Cash Equivalents and Marketable Securities; Novo Nordisk Collaboration to Significantly Extend Prior Runway Guidance of Early 2028 SOUTH SAN FRANCISCO, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted key business updates and upcoming milestones and reported financial results for the first quarter ended March 31, 2025. “Yesterday’s landmark partnership announcement with Novo Nordisk to advance our incretin programs is an important validation of our GPCR Native Complex Platform™ and its potential to address major unmet needs in metabolic disease,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “This collaboration provides a significant opportunity to create multiple potentially groundbreaking oral medicines, while also providing Septerna with substantial resources and operational flexibility to advance our diverse portfolio. In parallel, we continue to advance our wholly owned pipeline, including our next-generation oral small molecule PTH1R agonist for hypoparathyroidism, where we remain on track to select a development candidate to advance toward the clinic later this year. Additionally, our SEP-631 program targeting mast cell diseases is progressing well, with clinical trial initiation expected in the third quarter of this year. With a strong balance sheet, a differentiated technology platform, and a clear focus on execution, we believe we are well positioned to create long-term value for patients and shareholders.” Corporate Overview and Anticipated Milestones PTH1R Agonist Program: Septerna continues to advance multiple lead compounds with distinct chemical structures unrelated to its first-generation oral small molecule, SEP-786, each with favorable pharmacokinetics (PK) profiles that support the potential for full-day calcium control in hypoparathyroidism patients with either once- or twice-daily dosing. Septerna plans to select a next-generation parathyroid hormone 1 receptor (PTH1R) agonist candidate to accelerate toward the clinic by the end of 2025. SEP-631 MRGPRX2 NAM Program: Septerna anticipates initiating a Phase 1 clinical trial to assess safety, tolerability, PK, and pharmacodynamics (through an icatibant skin challenge) of SEP-631 in healthy volunteers in the third quarter of 2025. SEP-631 is a selective oral small molecule MRGPRX2 negative allosteric modulator (NAM) in development for the treatment of mast cell diseases, including chronic spontaneous urticaria. TSHR NAM Program: Septerna continues to progress several TSHR NAM lead compounds, designed to be a disease-modifying treatment for Graves’ disease and thyroid eye disease, towards selection of a development candidate. Collaboration Agreement with Novo Nordisk On May 14, 2025, Septerna and Novo Nordisk announced a global collaboration agreement to discover, develop and commercialize multiple potential oral small molecule medicines for obesity, type 2 diabetes and other cardiometabolic diseases based on certain specified molecular targets. The companies will initially commence four simultaneous research and development (R&D) programs for small molecule therapies directed to one or more select GPCR targets, including the GLP-1, GIP and glucagon receptors. Under the terms of the agreement, Septerna is eligible to receive approximately $2.2 billion from Novo Nordisk across an upfront payment and research, development and commercial milestone payments. This includes more than $200 million in upfront and near-term milestone payments. Septerna is also eligible to receive tiered royalties on global net sales of marketed products. Novo Nordisk will cover all R&D expenses for partnered programs under the collaboration. In addition, Septerna has the right to opt-in to a worldwide profit-share for one program, in lieu of future milestones and royalties for that product candidate. More details can be found in the Current Report on Form 8-K filed on May 14, 2025. First Quarter 2025 Financial Results Cash Position: Cash, cash equivalents, and marketable securities totaled $398.2 million as of March 31, 2025. Septerna expects the upfront payment from the collaboration with Novo Nordisk to significantly extend its prior cash runway guidance of early 2028 and plans to provide updated guidance following the closing of the collaboration agreement. R&D Expenses: R&D expenses were $19.3 million for the quarter ended March 31, 2025, compared to $13.2 million for the quarter ended March 31, 2024. G&A Expenses: General and administrative (G&A) expenses were $6.9 million for the quarter ended March 31, 2025, compared to $2.7 million for the quarter ended March 31, 2024. Net Loss: Net loss was $21.5 million for the quarter ended March 31, 2025, compared to $14.2 million for the quarter ended March 31, 2024. About Septerna Septerna, Inc. is a biotechnology company pioneering a new era of GPCR drug discovery powered by its proprietary Native Complex Platform™. Its industrial-scale platform aims to unlock the full potential of GPCR therapies and has led to the discovery and development of its deep pipeline of oral small molecule product candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases. Septerna was launched by preeminent drug discovery company builders and scientific leaders in the biochemistry, structural biology, and pharmacology of GPCRs. For more information, please visit www.septerna.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Septerna’s beliefs and expectations regarding: the expectations regarding the timing and closing of the collaboration agreement with Novo Nordisk, including the expiration or termination of the waiting period (and any extension thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976; the intended and potential benefits of the collaboration with Novo Nordisk, including the receipt of expected upfront payment upon the effectiveness of the collaboration agreement and potential milestone and royalty payments from commercial product sales, along with tiered royalties based on global net sales, if any; the continued development and advancement of Septerna’s oral small molecule GPCR-targeted programs; its ability to demonstrate, and the timing of, preclinical proof-of-concept in vivo and ex vivo for multiple programs, including Septerna’s plan to select a next-generation PTH1R product candidate to accelerate toward the clinic later this year; its ability to advance any product candidates that it may identify and successfully complete any clinical studies; the initiation, timing, progress, and results of conducting its research and development programs, including its plans to initiate a clinical trial for SEP-631 in the third quarter of this year; the potential of its proprietary Native Complex Platform™; its expectations regarding the implementation of its business model, strategic plans for its business, product candidates, and technology, and the accuracy of its estimates regarding expenses and capital requirements, including its expected cash runway being significantly beyond Septerna’s prior guidance of into early 2028. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: uncertainties related to achieving the future potential research, development, and commercial milestones under the Novo Nordisk collaboration; uncertainties related to Septerna’s product candidates entering clinical trials; the authorization, initiation, and successful completion of preclinical and Investigational New Drug (IND)-enabling studies to support future clinical development of potential product candidates (including those for the PTH1R program), including uncertainties related to opening INDs and obtaining regulatory approvals; risks related to clinical development outcomes including unexpected safety or efficacy findings; the results of preclinical studies, or clinical studies not being predictive of future results in connection with future studies; the scope of protection Septerna is able to establish and maintain for intellectual property rights covering its Native Complex Platform™ and its product candidates; Septerna’s ability to identify and enter into future license agreements and collaborations; and general economic, industry and market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Septerna’s Annual Report on Form 10-K for the year ended December 31, 2024, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Septerna’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Septerna explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Investor Contact: Renee Leck, THRUST [email protected] Media Contact: Carly Scaduto [email protected]

