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Investor releaseQuarter not tagged2026-05-31This $5.5 Million Exit Raises Questions After Wave Life Sciences' Rough First Quarter
Motley Fool
This $5.5 Million Exit Raises Questions After Wave Life Sciences' Rough First Quarter
On May 15, 2026, Exome Asset Management reported selling out of Wave Life Sciences (NASDAQ:WVE), liquidating 421,488 shares in an estimated $5.49 million trade based on quarterly average pricing. According to an SEC filing dated May 15, 2026, Exome Asset Management sold its entire stake of 421,488 shares in Wave Life Sciences. The estimated value of the transaction is $5.49 million, calculated using the average closing price during the first quarter of 2026. The quarter-end value of Exome’s position in the company dropped by $7.17 million, a figure that includes both trading activity and price fluctuations. Exome Asset Management LLC fully exited its Wave Life Sciences position, which was previously 3.4% of the fund’s AUM. Top holdings after the filing: As of May 14, 2026, shares of Wave Life Sciences were priced at $6.90, up 8% over the past year, underperforming the S&P 500 by nearly 20 percentage points. Wave Life Sciences develops stereopure oligonucleotide therapies targeting neurological, hepatic, and genetic disorders, with clinical candidates including WVE-004 (ALS/FTD), WVE-003 (Huntington's disease), and WVE-N531 (Duchenne muscular dystrophy). The firm operates a clinical-stage biotechnology business model focused on proprietary drug discovery and development, leveraging its PRISM platform and strategic collaborations to advance a pipeline of RNA-targeted medicines. It serves pharmaceutical partners, research institutions, and patients with rare and serious genetic diseases, primarily in neurology and hepatology. Wave Life Sciences is a clinical-stage biotechnology company specializing in the design and development of stereopure oligonucleotide therapeutics. It leverages its proprietary PRISM platform and strategic partnerships to advance a diversified pipeline targeting neurological and hepatic indications. The company’s focus on precision genetic medicines positions it to address unmet medical needs in rare and complex diseases, supported by collaborations with leading global pharmaceutical and academic partners. The performance of early-stage biotechs is highly contingent on clinical execution, meaning investment outcomes can hinge on a handful of data releases and regulatory decisions rather than steady operating performance. That’s notable here because Wave shares took a massive tumble in late March, collapsing roughly 50% in one day after new…Read full documentShow less
On May 15, 2026, Exome Asset Management reported selling out of Wave Life Sciences (NASDAQ:WVE), liquidating 421,488 shares in an estimated $5.49 million trade based on quarterly average pricing. According to an SEC filing dated May 15, 2026, Exome Asset Management sold its entire stake of 421,488 shares in Wave Life Sciences. The estimated value of the transaction is $5.49 million, calculated using the average closing price during the first quarter of 2026. The quarter-end value of Exome’s position in the company dropped by $7.17 million, a figure that includes both trading activity and price fluctuations. Exome Asset Management LLC fully exited its Wave Life Sciences position, which was previously 3.4% of the fund’s AUM. Top holdings after the filing: As of May 14, 2026, shares of Wave Life Sciences were priced at $6.90, up 8% over the past year, underperforming the S&P 500 by nearly 20 percentage points. Wave Life Sciences develops stereopure oligonucleotide therapies targeting neurological, hepatic, and genetic disorders, with clinical candidates including WVE-004 (ALS/FTD), WVE-003 (Huntington's disease), and WVE-N531 (Duchenne muscular dystrophy). The firm operates a clinical-stage biotechnology business model focused on proprietary drug discovery and development, leveraging its PRISM platform and strategic collaborations to advance a pipeline of RNA-targeted medicines. It serves pharmaceutical partners, research institutions, and patients with rare and serious genetic diseases, primarily in neurology and hepatology. Wave Life Sciences is a clinical-stage biotechnology company specializing in the design and development of stereopure oligonucleotide therapeutics. It leverages its proprietary PRISM platform and strategic partnerships to advance a diversified pipeline targeting neurological and hepatic indications. The company’s focus on precision genetic medicines positions it to address unmet medical needs in rare and complex diseases, supported by collaborations with leading global pharmaceutical and academic partners. The performance of early-stage biotechs is highly contingent on clinical execution, meaning investment outcomes can hinge on a handful of data releases and regulatory decisions rather than steady operating performance. That’s notable here because Wave shares took a massive tumble in late March, collapsing roughly 50% in one day after new data showed that a higher dose of its obesity candidate, WVE-007, failed to show meaningful improvement in reducing a type of belly fat.Nevertheless, the firm seemed optimistic in its latest earnings release. CEO Paul Bolno said the company is "accelerating" development of WVE-007 following encouraging early body composition data and remains on track across several pipeline programs. Financially, Wave generated $38.2 million in first-quarter revenue, up from $9.2 million a year earlier, while narrowing its net loss to $26.1 million from $46.9 million. It ended March with $544.6 million in cash and expects that funding to last into the third quarter of 2028.Ultimately, this remains a pipeline story, and Exome's exit may reflect risk management, but the next meaningful driver of returns will likely be clinical and regulatory execution rather than institutional trading activity. Before you buy stock in Wave Life Sciences, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Wave Life Sciences wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $463,900!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,294,401!* Now, it’s worth noting Stock Advisor’s total average return is 978% — a market-crushing outperformance compared to 211% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 31, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Guardant Health and Ionis Pharmaceuticals. The Motley Fool has a disclosure policy. This $5.5 Million Exit Raises Questions After Wave Life Sciences' Rough First Quarter was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-05-05Cogent Biosciences Reports Recent Business Highlights and First Quarter 2026 Financial Results
GlobeNewswire
Cogent Biosciences Reports Recent Business Highlights and First Quarter 2026 Financial Results
- Planning for dual launches of bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST) - Pivotal data from Phase 3 PEAK trial in GIST patients selected for oral presentation at 2026 ASCO annual meeting - Ended 1Q 2026 with $866.4 million in cash, sufficient to fund operations into 2028 WALTHAM, Mass. and BOULDER, Colo., May 05, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2026. “2026 is shaping up to be a pivotal year for Cogent,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We have two NDAs for bezuclastinib under FDA review and expect to submit a third in the first half of this year. These milestones highlight the breadth of bezuclastinib’s potential across GIST and KIT-driven diseases. With a strong balance sheet, we are focused on completing our commercial build and preparing for multiple potential launches.” Recent Business Highlights Announced details for an oral presentation on May 30 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting featuring pivotal data from the Phase 3 PEAK trial in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib Presented updated preclinical data from the company’s KRAS and ErbB2 candidates at the American Association of Cancer Research (AACR) annual meeting Announced submission of the company’s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with GIST who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamlined review process. Bezuclastinib was also granted Breakthrough Therapy Designation as a treatment for GIST earlier in 2026. Announced the FDA accepted its NDA for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026 Presented six posters with bezuclastinib in patients with NonAdvSM at the 2026 AAAAI annual meeting Initiated Phase 1 st…Read full documentShow less
- Planning for dual launches of bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST) - Pivotal data from Phase 3 PEAK trial in GIST patients selected for oral presentation at 2026 ASCO annual meeting - Ended 1Q 2026 with $866.4 million in cash, sufficient to fund operations into 2028 WALTHAM, Mass. and BOULDER, Colo., May 05, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2026. “2026 is shaping up to be a pivotal year for Cogent,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We have two NDAs for bezuclastinib under FDA review and expect to submit a third in the first half of this year. These milestones highlight the breadth of bezuclastinib’s potential across GIST and KIT-driven diseases. With a strong balance sheet, we are focused on completing our commercial build and preparing for multiple potential launches.” Recent Business Highlights Announced details for an oral presentation on May 30 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting featuring pivotal data from the Phase 3 PEAK trial in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib Presented updated preclinical data from the company’s KRAS and ErbB2 candidates at the American Association of Cancer Research (AACR) annual meeting Announced submission of the company’s New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with GIST who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamlined review process. Bezuclastinib was also granted Breakthrough Therapy Designation as a treatment for GIST earlier in 2026. Announced the FDA accepted its NDA for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026 Presented six posters with bezuclastinib in patients with NonAdvSM at the 2026 AAAAI annual meeting Initiated Phase 1 studies for both CGT4255, a novel, selective, brain-penetrant ErbB2 inhibitor and CGT6297, a novel, selective and potential best-in-class PI3Kα inhibitor Upcoming Milestones Bezuclastinib Submit the APEX NDA in the first half of 2026 for bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM) Present detailed clinical data from the Phase 3 PEAK pivotal trial at the 2026 ASCO annual meeting and from the APEX pivotal trial in the first half of 2026 Initiate a Phase 2 trial in the first half of 2026 investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib Pending FDA approval(s), launch bezuclastinib in the second half of 2026 Pipeline Submit Investigational New Drug (IND) applications for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor Complete dose escalation for CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor Bezuclastinib - Expanded Access Program Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. For more information please visit: https://www.cogentbio.com/bezuclastinib-program-development/#our-expanded-access-policy Upcoming Investor Conference Jefferies Healthcare Conference on June 3 at 11:05 a.m. ET. A live webcast can be accessed on the Investors & Media page of Cogent’s website at investors.cogentbio.com/events. A replay will be available approximately two hours after completion of the event and will be archived for up to 30 days. First Quarter 2026 Financial Results Cash and Cash Equivalents: As of March 31, 2026, cash, cash equivalents and marketable securities were $866.4 million, which includes net proceeds of $45.7 million from shares recently sold under the Company’s at-the-market (ATM) stock offering as well as non-recurring payments totaling $18.0 million related to annual performance-based bonus compensation and a milestone payment to Plexxikon. Based on our current plans, we expect our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements into 2028, including the commercialization of bezuclastinib in SM and GIST. R&D Expenses: Research and development expenses were $75.4 million for the first quarter of 2026 compared to $63.0 million for the first quarter of 2025. The increase was driven by increased early-stage, preclinical and discovery programs as we advance our pipeline of programs into Phase 1 clinical trials and IND-enabling studies, and includes one-time costs associated with the wind down of the FGFR clinical program. R&D expenses include non-cash stock compensation expense of $8.9 million for the first quarter of 2026 as compared to $5.3 million for the first quarter of 2025. G&A Expenses: General and administrative expenses were $28.2 million for the first quarter of 2026 compared to $11.9 million for the first quarter of 2025. The increase was primarily due to the growth of the organization and activities related to the anticipated commercial launch of bezuclastinib. G&A expenses include non-cash stock compensation expense of $8.0 million for the first quarter of 2026 as compared to $4.8 million for the first quarter of 2025. Net Loss: Net loss was $97.4 million for the first quarter of 2026 compared to a net loss of $72.0 million for the first quarter of 2025. Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Cogent also announced today that, on April 29, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of “inducement” equity awards to seven new employees under the company’s 2020 Inducement Plan with a grant date of April 29, 2026. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 62,600 shares of Cogent common stock and (ii) 48,600 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually in equal installments over 4 years from the grant date, provided such employee remains employed through each such vesting date. About Cogent Biosciences, Inc. Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving Systemic Mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced Gastrointestinal Stromal Tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα, KRAS and JAK2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the anticipated commercial launches of bezuclastinib in SM and GIST starting in the second half of 2026; the anticipated cash runway into 2028; the expectation to submit an NDA for bezuclastinib in patients with AdvSM in the first half of 2026; anticipated presentations of clinical data from PEAK and APEX; plans to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib; plans to submit INDs for CGT1815, the company’s novel, selective pan-KRAS(ON) inhibitor, and CGT1145, the company’s novel, selective JAK2 V617F inhibitor; and plans to complete dose escalation studies for CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof. Contact: Christi Waarich Senior Director, Investor Relations [email protected] 617-830-1653
Investor releaseQuarter not tagged2026-03-18This Biotech Fund Sold $8 Million of Terns Stock Last Quarter, but Here's Why It Still Seems Very Bullish
Motley Fool
This Biotech Fund Sold $8 Million of Terns Stock Last Quarter, but Here's Why It Still Seems Very Bullish
On February 17, 2026, Superstring Capital Management reported selling 345,869 shares of Terns Pharmaceuticals (NASDAQ:TERN) in the fourth quarter, an estimated $7.99 million trade based on quarterly average pricing. According to a February 17, 2026, SEC filing, Superstring Capital Management reduced its position in Terns Pharmaceuticals by 345,869 shares during the fourth quarter of 2025. The estimated value of the trade, derived from the average closing price for the quarter, was $7.99 million. The fund’s quarter-end position in Terns Pharmaceuticals decreased in value by approximately $12.00 million, reflecting both share sales and stock price moves. Top holdings after the filing: NASDAQ:CDTX: $18.80 million (10.1% of AUM) NASDAQ:TERN: $17.93 million (9.6% of AUM) NASDAQ:URGN: $16.82 million (9.0% of AUM) NASDAQ:COGT: $13.01 million (7.0% of AUM) NASDAQ:DVAX: $8.08 million (4.3% of AUM) As of Wednesday, Terns shares were priced at $45.56, up a staggering 1,300% over the past year and vastly outperforming the S&P 500’s roughly 19% gain in the same period. Terns develops small-molecule therapies targeting chronic myeloid leukemia (CML), non-alcoholic steatohepatitis (NASH) and obesity, with lead candidates including TERN-101, TERN-201, TERN-501, and TERN-601 in various stages of clinical development. The firm operates a clinical-stage biopharmaceutical business model focused on advancing proprietary drug candidates through early- and mid-stage trials, aiming for eventual regulatory approval and commercialization or strategic partnerships. It has targeted patients with NASH and metabolic diseases, addressing unmet needs in the global healthcare and biotechnology markets. Even after trimming Terns, the stock remains one of the largest holdings in Superstring’s portfolio, which tells you this is not a loss of conviction but a recalibration after an extraordinary move. A 1,300% gain in a single year is staggering, and it certainly creates some expectations, which matter in biotech, where outcomes hinge on trial execution and regulatory milestones rather than steady revenue growth. The underlying story, however, is still compelling. Terns has repositioned around oncology, with its lead program for chronic myeloid leukemia showing strong early efficacy and a slate of catalysts expected this year, including dose selection and pivotal trial progress. Meanwhile, roug…Read full documentShow less
On February 17, 2026, Superstring Capital Management reported selling 345,869 shares of Terns Pharmaceuticals (NASDAQ:TERN) in the fourth quarter, an estimated $7.99 million trade based on quarterly average pricing. According to a February 17, 2026, SEC filing, Superstring Capital Management reduced its position in Terns Pharmaceuticals by 345,869 shares during the fourth quarter of 2025. The estimated value of the trade, derived from the average closing price for the quarter, was $7.99 million. The fund’s quarter-end position in Terns Pharmaceuticals decreased in value by approximately $12.00 million, reflecting both share sales and stock price moves. Top holdings after the filing: NASDAQ:CDTX: $18.80 million (10.1% of AUM) NASDAQ:TERN: $17.93 million (9.6% of AUM) NASDAQ:URGN: $16.82 million (9.0% of AUM) NASDAQ:COGT: $13.01 million (7.0% of AUM) NASDAQ:DVAX: $8.08 million (4.3% of AUM) As of Wednesday, Terns shares were priced at $45.56, up a staggering 1,300% over the past year and vastly outperforming the S&P 500’s roughly 19% gain in the same period. Terns develops small-molecule therapies targeting chronic myeloid leukemia (CML), non-alcoholic steatohepatitis (NASH) and obesity, with lead candidates including TERN-101, TERN-201, TERN-501, and TERN-601 in various stages of clinical development. The firm operates a clinical-stage biopharmaceutical business model focused on advancing proprietary drug candidates through early- and mid-stage trials, aiming for eventual regulatory approval and commercialization or strategic partnerships. It has targeted patients with NASH and metabolic diseases, addressing unmet needs in the global healthcare and biotechnology markets. Even after trimming Terns, the stock remains one of the largest holdings in Superstring’s portfolio, which tells you this is not a loss of conviction but a recalibration after an extraordinary move. A 1,300% gain in a single year is staggering, and it certainly creates some expectations, which matter in biotech, where outcomes hinge on trial execution and regulatory milestones rather than steady revenue growth. The underlying story, however, is still compelling. Terns has repositioned around oncology, with its lead program for chronic myeloid leukemia showing strong early efficacy and a slate of catalysts expected this year, including dose selection and pivotal trial progress. Meanwhile, roughly $1 billion in cash provides runway into 2031, reducing the firm’s near-term financing risk thanks largely to a massive $747.5 million offering in December. If catalysts deliver positive results and Terns can launch its inhibitor by 2031, the recent share surge might prove to have legs. Before you buy stock in Terns Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Terns Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $508,877!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,115,328!* Now, it’s worth noting Stock Advisor’s total average return is 936% — a market-crushing outperformance compared to 189% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of March 18, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This Biotech Fund Sold $8 Million of Terns Stock Last Quarter, but Here's Why It Still Seems Very Bullish was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-02-17Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results
GlobeNewswire
Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2025 Financial Results
SUMMIT NDA for bezuclastinib in patients with NonAdvSM submitted in December 2025; APEX NDA submission for bezuclastinib in patients with AdvSM on track for 1H 2026 PEAK NDA initiated for bezuclastinib in patients with 2L GIST under Real-Time Oncology Review (RTOR) and Breakthrough Therapy Designation (BTD); completion of NDA on track for April 2026 Six abstracts from SUMMIT trial of bezuclastinib in patients with NonAdvSM accepted for presentation at 2026 AAAAI annual meeting Strong financial position with $901 million sufficient to fund operations into 2028 WALTHAM, Mass. and BOULDER, Colo., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2025. “Following three positive pivotal trials in 2025, we have entered 2026 with tremendous momentum and multiple value-creating regulatory catalysts underway,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We have submitted our SUMMIT NDA for bezuclastinib in patients with NonAdvSM, initiated our PEAK NDA under the FDA’s RTOR program for bezuclastinib in patients with second-line GIST, and remain on track to submit our APEX NDA for bezuclastinib in patients with AdvSM in the first half of this year. These recent and upcoming milestones underscore the breadth of bezuclastinib’s best-in-class potential across KIT-mutant driven diseases. With a very strong balance sheet entering 2026, we will soon finish building our commercial organization and will be ready to launch bezuclastinib in the second half of 2026.” Recent Company Highlights In February 2026, announced that six abstracts from the SUMMIT trial of bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) have been accepted for presentation at the 2026 AAAAI annual meeting. In January 2026, announced that the U. S. Food and Drug Administration (FDA) agreed to accept the PEAK NDA for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program. Shortly thereafter Cogent initiated the NDA submission to the FDA under this program. Based on the results from the PEAK trial, in January 2026 bezucl…Read full documentShow less
SUMMIT NDA for bezuclastinib in patients with NonAdvSM submitted in December 2025; APEX NDA submission for bezuclastinib in patients with AdvSM on track for 1H 2026 PEAK NDA initiated for bezuclastinib in patients with 2L GIST under Real-Time Oncology Review (RTOR) and Breakthrough Therapy Designation (BTD); completion of NDA on track for April 2026 Six abstracts from SUMMIT trial of bezuclastinib in patients with NonAdvSM accepted for presentation at 2026 AAAAI annual meeting Strong financial position with $901 million sufficient to fund operations into 2028 WALTHAM, Mass. and BOULDER, Colo., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2025. “Following three positive pivotal trials in 2025, we have entered 2026 with tremendous momentum and multiple value-creating regulatory catalysts underway,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We have submitted our SUMMIT NDA for bezuclastinib in patients with NonAdvSM, initiated our PEAK NDA under the FDA’s RTOR program for bezuclastinib in patients with second-line GIST, and remain on track to submit our APEX NDA for bezuclastinib in patients with AdvSM in the first half of this year. These recent and upcoming milestones underscore the breadth of bezuclastinib’s best-in-class potential across KIT-mutant driven diseases. With a very strong balance sheet entering 2026, we will soon finish building our commercial organization and will be ready to launch bezuclastinib in the second half of 2026.” Recent Company Highlights In February 2026, announced that six abstracts from the SUMMIT trial of bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) have been accepted for presentation at the 2026 AAAAI annual meeting. In January 2026, announced that the U. S. Food and Drug Administration (FDA) agreed to accept the PEAK NDA for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program. Shortly thereafter Cogent initiated the NDA submission to the FDA under this program. Based on the results from the PEAK trial, in January 2026 bezuclastinib was also granted Breakthrough Therapy Designation for this patient population. In December 2025, presented full data from the SUMMIT trial evaluating bezuclastinib in patients with NonAdvSM, at the American Society of Hematology (ASH) annual meeting, and submitted an NDA for bezuclastinib in NonAdvSM, supported by the SUMMIT dataset. Key findings from SUMMIT included: Clear clinical benefit across all symptom domains, including significant improvements across 11 individual symptoms and the most severe symptom at baseline Reduction in objective measures of disease, including serum tryptase, correlating with improvements in symptom severity, representing the first demonstration of this relationship in NonAdvSM patients Forty-eight-week data showing continued deepening of symptomatic improvement over time In December 2025, announced topline results from the APEX trial evaluating bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM), APEX is a registration-directed, global, open-label trial evaluating bezuclastinib in patients with AdvSM. Key findings included: Rapid and deep clinical benefit, with an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria A powerful effect on mast cell burden, with 89% of patients achieving a ≥50% reduction in bone marrow mast cells or clearance of aggregates In December 2025, announced initial preclinical results from the company’s novel, potent, selective JAK2 V617F inhibitor CGT1145 at the ASH annual meeting. These results showcased greater than 100-fold selectivity for JAK2 V617F mutations over JAK2 WT inhibition, positioning CGT1145 with a potential best-in-class profile. In November 2025, successfully completed concurrent public offerings of common stock and convertible senior notes for net proceeds of approximately $546.8 million. In November 2025, announced topline results from the Phase 3 PEAK trial of bezuclastinib in combination with sunitinib for patients with GIST who have received prior treatment with imatinib, becoming the first positive Phase 3 trial in second-line GIST patients in over 20 years. Highlights include: 16.5 months median progression free survival (mPFS) for bezuclastinib plus sunitinib compared to 9.2 months mPFS for sunitinib monotherapy (HR=0.50, CI: 0.39-0.65; p<0.0001) 46% Objective Response Rate (ORR) reported for bezuclastinib combination compared to 26% ORR for sunitinib monotherapy (p<0.0001) The safety profile of the bezuclastinib combination was well tolerated with no unique risks observed with the combination when compared to the known safety profile of sunitinib In October 2025, shared progress on Cogent’s internally developed KRAS(ON/OFF) inhibitor CGT1263 in a poster at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Updated results demonstrated clear selectivity over HRAS and NRAS, with picomolar (pM) activity across a broad panel of KRAS mutant cell lines. In addition, the poster also characterized CGT1815 (the prodrug of CGT1263), which is designed to optimize human pharmacokinetic performance, supported by pharmacokinetics data from both CGT1815 and CGT1263 across multiple species. Finally, the poster highlighted outcompete data in KRASG12D and KRASG12V tumor growth inhibition studies when compared to other KRAS exemplars including RMC-6236. Projected Near-Term Milestones Bezuclastinib Acceptance of the NDA for bezuclastinib in NonAdvSM in February 2026 Complete submission of PEAK NDA in April 2026 for bezuclastinib in patients with GIST who have received prior treatment with imatinib Submit APEX NDA in 1H 2026 for bezuclastinib in patients with AdvSM Present detailed clinical data from the PEAK and APEX pivotal trials at major medical meetings during 1H 2026 Present updated SUMMIT data across six poster presentations at the AAAAI Annual meeting in February 2026 Pending FDA approval, launch bezuclastinib in the second half of 2026 Pipeline Submit Investigational New Drug (IND) applications for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor Share clinical data on CGT4859, Cogent’s selective and potent FGFR 2/3 inhibitor, from its Phase 1/2 study in patients with alterations in FGFR2 or FGFR3 Complete dose escalation for both CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor, and CGT6297, Cogent’s novel, selective PI3Kα inhibitor Bezuclastinib - Expanded Access Program Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. A growing number of sites now offer access to the bezuclastinib EAPs. For more information please visit: https://www.cogentbio.com/bezuclastinib-program-development/#our-expanded-access-policy Upcoming Investor Conference Leerink Healthcare Conference on Wednesday, March 11 at 10:40 a.m. ET. A live webcast can be accessed on the Investors & Media page of Cogent’s website at investors.cogentbio.com/events. A replay will be available approximately two hours after completion of the event and will be archived for up to 30 days. Fourth Quarter and Full Year 2025 Financial Results Cash and Cash Equivalents: As of December 31, 2025, Cogent had cash, cash equivalents and marketable securities of $900.8 million. Fourth quarter cash usage was driven largely by non-recurring items, including the repayment of $54.8 million of long-term debt and approximately $38.5 million of one-time, performance-based equity compensation. R&D Expenses: Research and development expenses were $75.6 million for the fourth quarter of 2025 and $269.8 million for the year ended December 31, 2025, as compared to $62.0 million for the fourth quarter of 2024 and $232.7 million for the year ended December 31, 2024. The change was driven by the continued development of bezuclastinib across three pivotal trials, including costs associated with the completed and planned NDA filings, as well as the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $7.5 million for the fourth quarter of 2025 and $23.1 million for the year ended December 31, 2025, as compared to $5.0 million for the fourth quarter of 2024 and $19.0 million for the year ended December 31, 2024. G&A Expenses: General and administrative expenses were $23.9 million for the fourth quarter of 2025 and $63.6 million for the year ended December 31, 2025, as compared to $11.7 million for the fourth quarter of 2024 and $43.3 million for the year ended December 31, 2024. The increase was primarily due to the growth of the organization and activities related to the anticipated commercial launch of bezuclastinib. G&A expenses include non-cash stock compensation expense of $8.3 million for the fourth quarter of 2025 and $23.0 million for the year ended December 31, 2025, as compared to $5.0 million for the fourth quarter of 2024 and $20.8 million for the year ended December 31, 2024. Net Loss: Net loss was $102.5 million for the fourth quarter of 2025 and $328.9 million for the year ended December 31, 2025, as compared to a net loss of $67.9 million for the fourth quarter of 2024 and $255.9 million for the year ended December 31, 2024. Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Cogent also announced today that, on February 11, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of “inducement” equity awards to twelve new employees under the company’s 2020 Inducement Plan with grant dates of February 11, 2026 and February 16, 2026. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 59,300 shares of Cogent common stock and (ii) 47,000 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually in equal installments over 4 years from the grant date, provided such employee remains employed through each such vesting date. About Cogent Biosciences, Inc. Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving Systemic Mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced Gastrointestinal Stromal Tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα, KRAS and JAK2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: plans to submit an NDA for bezuclastinib in patients with AdvSM in the first half of 2026; plans to complete the submission of an NDA for bezuclastinib in combination with sunitinib in patients with GIST in April 2026; the anticipated cash runway into 2028; bezuclastinib’s best-in-class potential across KIT-mutant driven diseases; plans to finish building a commercial organization and to launch bezuclastinib in the second half of 2026; the potential best-in-class profile of the company’s JAK2 V617F inhibitor; the expectation for FDA to accept the company’s NDA for bezuclastinib in NonAdvSM in February 2026; plans to present additional clinical data from the PEAK and APEX trials at major medical meetings during the first half of 2026; and plans to submit INDs and present data on the company’s pre-clinical and early clinical stage candidates. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Cogent’s most recent Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date the date hereof. Contact: Christi Waarich Senior Director, Investor Relations [email protected] 617-830-1653
Investor releaseQuarter not tagged2025-12-08Cogent Biosciences Announces Positive Top-line Results of APEX Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)
GlobeNewswire
Cogent Biosciences Announces Positive Top-line Results of APEX Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)
-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden with 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates – -- Bezuclastinib was very well tolerated with only 14.8% of patients requiring dose reduction and no patients requiring discontinuation due to treatment related adverse events -- -- APEX NDA submission expected in 1H 2026 – -- Cogent to host investor conference call and webcast today at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ: COGT) today announced positive top-line results from the registration-directed APEX Part 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) demonstrating clinically meaningful results as measured by consensus criteria used to assess patient response. This is the third positive pivotal trial result for bezuclastinib in 2025, following positive announcements from the SUMMIT trial in NonAdvSM patients and the PEAK trial in GIST patients earlier this year. Based on these top-line data, Cogent expects to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in AdvSM during the first half of 2026. In addition, Cogent plans to present detailed data from the APEX trial at an upcoming scientific meeting in the first half of 2026. “We are excited to announce the third positive pivotal trial for bezuclastinib this year. The results from the APEX trial demonstrate the clear benefit that a highly selective, highly potent KIT mutant inhibitor is capable of providing to patients with AdvSM,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “Coupling rapid, deep, durable responses with the safety and tolerability profile demonstrated by bezuclastinib provides these patients with a new choice to fight their disease without compromising their quality of life. With positive results from APEX, taken together with data from SUMMIT and PEAK, Cogent is preparing for multiple commercial launches in the second half of 2026.” In Part 2 of the APEX trial, 81 AdvSM patients were treated with 150 mg of bezuclastinib, including 57 pat…Read full documentShow less
-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden with 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates – -- Bezuclastinib was very well tolerated with only 14.8% of patients requiring dose reduction and no patients requiring discontinuation due to treatment related adverse events -- -- APEX NDA submission expected in 1H 2026 – -- Cogent to host investor conference call and webcast today at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ: COGT) today announced positive top-line results from the registration-directed APEX Part 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) demonstrating clinically meaningful results as measured by consensus criteria used to assess patient response. This is the third positive pivotal trial result for bezuclastinib in 2025, following positive announcements from the SUMMIT trial in NonAdvSM patients and the PEAK trial in GIST patients earlier this year. Based on these top-line data, Cogent expects to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in AdvSM during the first half of 2026. In addition, Cogent plans to present detailed data from the APEX trial at an upcoming scientific meeting in the first half of 2026. “We are excited to announce the third positive pivotal trial for bezuclastinib this year. The results from the APEX trial demonstrate the clear benefit that a highly selective, highly potent KIT mutant inhibitor is capable of providing to patients with AdvSM,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “Coupling rapid, deep, durable responses with the safety and tolerability profile demonstrated by bezuclastinib provides these patients with a new choice to fight their disease without compromising their quality of life. With positive results from APEX, taken together with data from SUMMIT and PEAK, Cogent is preparing for multiple commercial launches in the second half of 2026.” In Part 2 of the APEX trial, 81 AdvSM patients were treated with 150 mg of bezuclastinib, including 57 patients with SM-AHN, 11 patients with ASM and 13 patients with MCL. 68 of these patients were mIWG-MRT-ECNM evaluable for assessment on the primary endpoint. Clinical activity analyzed from these patients showed: Primary endpoint: 57% ORR (CR+CRh+PR+CI) per mIWG-MRT-ECNM (mIWG) criteria 49% ORR (CR+CRh+PR) per mIWG At the time of data cut-off, multiple additional patients had achieved unconfirmed response criteria and remain on study awaiting follow-up assessment Key secondary endpoint: 80% ORR (CR+CRh+PR) per pure pathological response (PPR) criteria Median time to achieve response was 2.0 months and median duration of response is not yet mature. Bezuclastinib achieved clear and clinically significant reductions in objective disease markers for these AdvSM patients: “Bezuclastinib demonstrated the rapid, deep clinical activity we were expecting given its earlier clinical results,” said Daniel J. DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical School. “What is most exciting about these data is the impressive safety and tolerability results with no discontinuations due to treatment-related adverse events (TRAEs) and only infrequent dose modifications. With this profile, bezuclastinib will become an important treatment option for this patient population.” APEX Part 2 Safety and Tolerability The most frequent TRAEs reported on bezuclastinib treatment were hair color change (30.9%), neutropenia (29.6%), altered taste (28.4%), thrombocytopenia (24.7%) and ALT/AST elevations (20.9%). Only 14.8% of patients required dose reduction, and no patients discontinued due to TRAEs. The majority of transaminase elevations were of low grade, asymptomatic and reversible. Only one patient experienced Gr 3 transaminase elevation which fully resolved with dose reduction and the patient continues on therapy. Complete analysis of the full APEX Part 2 data are ongoing, and Cogent plans to present detailed results at an upcoming major medical conference in the first half of 2026. Webcast Details Cogent will host a live webcast today, Monday, December 8, at 8:00 a.m. ET to discuss the full data from SUMMIT in NonAdvSM shared at the American Society of Hematology (ASH) Annual Meeting as well as today’s APEX top-line results. The live event will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days. Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Cogent also announced today that, on December 1, 2025 and December 5, 2025, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of “inducement” equity awards to thirteen new employees under the company’s 2020 Inducement Plan with grant dates of December 2, 2025 and December 8, 2025. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 294,600 shares of Cogent common stock and (ii) 34,000 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually over 4 years from the grant date, provided such employee remains employed through each such vesting date. About Cogent Biosciences, Inc. Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2/3 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα, KRAS and JAK2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding plans to submit an NDA to the FDA for bezuclastinib in AdvSM during the first half of 2026; plans to present detailed results from the APEX trial at an upcoming scientific meeting in the first half of 2026; the expectation that bezuclastinib will provide AdvSM patients with a new choice to fight their disease without compromising their quality of life; the expectation that Cogent will have multiple commercial launches in the second half of 2026 and the expectation that bezuclastinib will become an important treatment option for AdvSM patients. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof. Contact: Christi Waarich Senior Director, Investor Relations [email protected] 617-830-1653
Investor releaseQuarter not tagged2025-12-06Cogent Biosciences Presents Full SUMMIT Results of Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) at the 67th Annual Meeting of the American Society of Hematology (ASH)
GlobeNewswire
Cogent Biosciences Presents Full SUMMIT Results of Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) at the 67th Annual Meeting of the American Society of Hematology (ASH)
-- Bezuclastinib achieves clear clinical benefit across all symptom domains including significant improvements on 11 individual symptoms plus the most severe symptom at baseline -- -- Bezuclastinib demonstrates that reducing objective measures of disease, including serum tryptase, correlates with improvement in symptom severity; the first time this has been shown in NonAdvSM patients -- -- New 48-week data demonstrate a clear, continued deepening of symptomatic improvement over time -- -- Bezuclastinib demonstrated a favorable safety and tolerability profile supporting chronic use -- -- Granted Breakthrough Therapy Designation for bezuclastinib in October 2025; New Drug Application (NDA) on track for submission in December 2025 -- -- Cogent to host investor conference call and webcast on Monday, December 8, at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo., Dec. 06, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ: COGT) today announced complete results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM). As previously reported, bezuclastinib demonstrated clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints. New results further highlight the benefit of bezuclastinib on patient-reported symptoms and objective measures of mast cell burden and demonstrate significant correlation between improvement in disease pathology and patient-reported symptom severity. “We are excited to present additional data from the SUMMIT trial that support our conviction that bezuclastinib will be the best-in-class treatment option for patients with nonadvanced systemic mastocytosis,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We remain on track to submit our first New Drug Application for bezuclastinib in NonAdvSM with the FDA this month and are encouraged by the increased interest in our Expanded Access Program.” “Nonadvanced systemic mastocytosis patients currently have very limited treatment options, and the benefit bezuclastinib demonstrated in the SUMMIT trial across measures of disease pathology and symptomatic improvement is very exciting for this patient population,” said Lindsay Rein, MD, Associate Professor of Medicine in the Division of Hematologic Malignancies and Cellula…Read full documentShow less
-- Bezuclastinib achieves clear clinical benefit across all symptom domains including significant improvements on 11 individual symptoms plus the most severe symptom at baseline -- -- Bezuclastinib demonstrates that reducing objective measures of disease, including serum tryptase, correlates with improvement in symptom severity; the first time this has been shown in NonAdvSM patients -- -- New 48-week data demonstrate a clear, continued deepening of symptomatic improvement over time -- -- Bezuclastinib demonstrated a favorable safety and tolerability profile supporting chronic use -- -- Granted Breakthrough Therapy Designation for bezuclastinib in October 2025; New Drug Application (NDA) on track for submission in December 2025 -- -- Cogent to host investor conference call and webcast on Monday, December 8, at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo., Dec. 06, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ: COGT) today announced complete results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM). As previously reported, bezuclastinib demonstrated clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints. New results further highlight the benefit of bezuclastinib on patient-reported symptoms and objective measures of mast cell burden and demonstrate significant correlation between improvement in disease pathology and patient-reported symptom severity. “We are excited to present additional data from the SUMMIT trial that support our conviction that bezuclastinib will be the best-in-class treatment option for patients with nonadvanced systemic mastocytosis,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “We remain on track to submit our first New Drug Application for bezuclastinib in NonAdvSM with the FDA this month and are encouraged by the increased interest in our Expanded Access Program.” “Nonadvanced systemic mastocytosis patients currently have very limited treatment options, and the benefit bezuclastinib demonstrated in the SUMMIT trial across measures of disease pathology and symptomatic improvement is very exciting for this patient population,” said Lindsay Rein, MD, Associate Professor of Medicine in the Division of Hematologic Malignancies and Cellular Therapy, Duke University. “The SUMMIT trial results match my clinical experience using bezuclastinib with NonAdvSM patients, delivering rapid and deep improvement in symptom control and objective measures of disease without tolerability challenges.” SUMMIT Trial Data In the registration-directed Part 2 of the SUMMIT clinical trial, 118 patients received bezuclastinib once daily plus best supportive care (BSC) and 60 patients received placebo plus BSC. The study included adults with a NonAdvSM diagnosis confirmed by central pathology review, and moderate-to-severe symptom burden despite an optimized regimen of BSC. Following completion of the 24-week treatment period, patients had the option to receive bezuclastinib in an open-label extension study. Baseline patient demographics were balanced between treatment arms and reflected significant disease burden. Disease symptoms were assessed using the Mastocytosis Symptom Severity Daily Diary (MS2D2). Bezuclastinib delivered clinically meaningful and statistically significant symptomatic improvement Across several additional key secondary endpoints, bezuclastinib demonstrated rapid, deep and sustained improvement on objective disease markers of mast cell burden. At week 24, 87.4% of patients achieved ≥50% reduction in serum tryptase levels, 75.6% of patients demonstrated ≥50% reduction in bone marrow mast cells or clearance of aggregates and 85.7% of patients achieved ≥50% reduction in KIT D816V variant allele frequency or undetectable, each of which was statistically significant when compared to placebo. Additional pathobiology data from SUMMIT patients will be shared in an oral presentation on Monday, December 8th at ASH. SUMMIT Subgroups As part of the SUMMIT study, patients with Smoldering Systemic Mastocytosis (n=8 bezuclastinib arm, n=4 placebo arm) and patients who had previously been treated with avapritinib (n=11 bezuclastinib arm, n=3 placebo arm) were enrolled. Patients treated with bezuclastinib in these subgroups showed a mean change in TSS of -35.6 and -21.6, respectively. The response in objective measures of disease burden in these patients was consistent with results from the broader SUMMIT population, as were their related adverse events and overall tolerability. Safety Data As previously reported on July 7, 2025, the majority of treatment emergent adverse events (TEAEs) (98.3% in bezuclastinib arm vs. 88.3% in placebo arm) were of low grade. The most frequent TEAEs reported on bezuclastinib treatment were hair color change (69.5% bezuclastinib vs. 5.0% placebo), altered taste (23.7% bezuclastinib vs. 0% placebo), nausea (22.0% bezuclastinib vs. 13.3% placebo) and ALT/AST elevations (22.0% bezuclastinib vs. 6.6% placebo; ≥Gr 3, 5.9% vs. 0%). Serious AEs occurred in 4.2% of patients treated with bezuclastinib, compared to 5.0% of patients treated with placebo. Discontinuations due to treatment-related AEs occurred in 5.9% of patients treated with bezuclastinib, all due to ALT/AST elevations and all patients fully resolved. There were no hepatic AEs reported in any patient other than transient and manageable lab abnormalities. SUMMIT Long Term Follow-up Data from longer term follow-up in patients participating in the SUMMIT trial are expected to be presented at an upcoming scientific meeting in Q1 2026. Preliminary 48-week data will be shared during the investor call scheduled for Monday, December 8th. Webcast Information Cogent will host a live webcast on Monday, December 8, at 8:00 a.m. ET to discuss these additional data from SUMMIT in NonAdvSM. The live event will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days. About Cogent Biosciences, Inc. Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2/3 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα, KRAS and JAK2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: plans to submit an NDA to the FDA for bezuclastinib in patients with NonAdvSM in December 2025; the company’s belief that bezuclastinib will be the best-in-class treatment option for NonAdvSM patients and plans to present data from longer term follow-up in patients participating in the SUMMIT trial at an upcoming scientific meeting in Q1 2026. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Annual Report on Form 10-K filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof. Contact: Christi Waarich Senior Director, Investor Relations [email protected] 617-830-1653
Investor releaseQuarter not tagged2025-11-25Cogent Biosciences (COGT): Evaluating Valuation After Positive Phase 3 Cancer Trial Results and New Drug Plans
Simply Wall St.
Cogent Biosciences (COGT): Evaluating Valuation After Positive Phase 3 Cancer Trial Results and New Drug Plans
Cogent Biosciences (COGT) is attracting fresh attention after announcing positive Phase 3 PEAK trial data for its lead therapy, bezuclastinib combined with sunitinib, in patients with gastrointestinal stromal tumors resistant to imatinib. See our latest analysis for Cogent Biosciences. Cogent Biosciences’ strong momentum over the past month has caught the market’s eye, with a staggering 154.7% one-month share price return following positive Phase 3 data and another clinical conference appearance. This has helped fuel an exceptional year-to-date share price return of 394%, while its total shareholder return over the past year stands at 319%. Recent milestones are clearly building optimism for the future. If innovative biotech stories like Cogent’s spark your interest, you’ll want to check out the latest names gaining traction through our See the full list for free. With the stock up nearly 400% this year and analysts lifting price targets, investors now face a pivotal question: is Cogent Biosciences still undervalued, or is the market already pricing in future growth? With a current Price-to-Book Ratio of 30.1x, Cogent Biosciences is trading at a far higher valuation than both its industry and peer averages, suggesting the recent rally has pushed valuation beyond typical levels seen in biotech. The price-to-book ratio measures how much investors are willing to pay for each dollar of book value. It is often used to benchmark early-stage or pre-revenue biotech stocks with little or no earnings. For a company in Cogent’s situation, which is currently unprofitable with no meaningful revenue, this ratio is often a proxy for growth optimism and confidence in the pipeline. At 30.1x, Cogent’s price-to-book is not only 12 times the US biotech industry average of 2.6x, but also more than triple its peer group average of 8.8x. This premium implies the market sees transformative potential in its upcoming therapies. However, it also signals much of that future promise is already built into the current price. See what the numbers say about this price — find out in our valuation breakdown. Result: Price-to-Book Ratio of 30.1x (OVERVALUED) However, continued lack of revenue and ongoing net losses could limit future upside if pipeline milestones take longer than expected to materialize. Find out about the key risks to this Cogent Biosciences narrative. For those who want to e…Read full documentShow less
Cogent Biosciences (COGT) is attracting fresh attention after announcing positive Phase 3 PEAK trial data for its lead therapy, bezuclastinib combined with sunitinib, in patients with gastrointestinal stromal tumors resistant to imatinib. See our latest analysis for Cogent Biosciences. Cogent Biosciences’ strong momentum over the past month has caught the market’s eye, with a staggering 154.7% one-month share price return following positive Phase 3 data and another clinical conference appearance. This has helped fuel an exceptional year-to-date share price return of 394%, while its total shareholder return over the past year stands at 319%. Recent milestones are clearly building optimism for the future. If innovative biotech stories like Cogent’s spark your interest, you’ll want to check out the latest names gaining traction through our See the full list for free. With the stock up nearly 400% this year and analysts lifting price targets, investors now face a pivotal question: is Cogent Biosciences still undervalued, or is the market already pricing in future growth? With a current Price-to-Book Ratio of 30.1x, Cogent Biosciences is trading at a far higher valuation than both its industry and peer averages, suggesting the recent rally has pushed valuation beyond typical levels seen in biotech. The price-to-book ratio measures how much investors are willing to pay for each dollar of book value. It is often used to benchmark early-stage or pre-revenue biotech stocks with little or no earnings. For a company in Cogent’s situation, which is currently unprofitable with no meaningful revenue, this ratio is often a proxy for growth optimism and confidence in the pipeline. At 30.1x, Cogent’s price-to-book is not only 12 times the US biotech industry average of 2.6x, but also more than triple its peer group average of 8.8x. This premium implies the market sees transformative potential in its upcoming therapies. However, it also signals much of that future promise is already built into the current price. See what the numbers say about this price — find out in our valuation breakdown. Result: Price-to-Book Ratio of 30.1x (OVERVALUED) However, continued lack of revenue and ongoing net losses could limit future upside if pipeline milestones take longer than expected to materialize. Find out about the key risks to this Cogent Biosciences narrative. For those who want to explore the numbers and draw your own conclusions, crafting a personalized outlook is quick and easy. Start now with Do it your way. A great starting point for your Cogent Biosciences research is our analysis highlighting 1 key reward and 3 important warning signs that could impact your investment decision. Don’t wait for the next breakout star to pass you by. Take charge of your portfolio with fresh ideas powered by the Simply Wall Street Screener. Discover overlooked opportunities, tap into fast-moving sectors, and spot hidden value stocks before the crowd. The time to get ahead is now. Unearth stocks with rapid earnings growth and technology leadership by starting with these 26 AI penny stocks to see which companies are shaping tomorrow’s digital world. Secure long-term income potential as you compare high-yield options through these 14 dividend stocks with yields > 3% and build a more resilient investment portfolio. Target deep value opportunities and uncover potentially mispriced companies using these 922 undervalued stocks based on cash flows that others might be overlooking. 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. Companies discussed in this article include COGT. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2025-11-03Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2025 Financial Results
GlobeNewswire
Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2025 Financial Results
Phase 3 PEAK results in 2nd-line GIST patients expected in November; pivotal APEX results in AdvSM patients expected in December Breakthrough Therapy Designation granted for bezuclastinib; New Drug Application (NDA) filing for NonAdvSM remains on track for year-end 2025 Multiple bezuclastinib abstracts selected for presentation at the 67th Annual Meeting of the American Society of Hematology (ASH); SUMMIT data in NonAdvSM selected for two oral presentations Plan to showcase novel JAK2 V617F mutant-selective candidate at ASH 2025 Strong pro forma cash position of $430 million expected to fund operations through anticipated launch of bezuclastinib and into 2027 WALTHAM, Mass. and BOULDER, Colo., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported recent business highlights and financial results for the third quarter ended September 30, 2025. “Cogent had a very productive and busy third quarter and we now find ourselves weeks away from reporting top-line results from our Phase 3 PEAK trial of bezuclastinib plus sunitinib in Gastrointestinal Stromal Tumor (GIST) patients and our registration-directed APEX trial in Advanced Systemic Mastocytosis (AdvSM) patients. In addition, we are pleased to announce we will have three bezuclastinib presentations at ASH 2025, including two oral presentations focused on the results from the SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “On top of this progress, we recently presented updated preclinical data from our research pipeline that demonstrated potential best-in-class attributes of our pan-KRAS inhibitor and plan to describe for the first time at ASH 2025 our highly potent, highly selective JAK2 V617F mutant-selective inhibitor. Both of these programs are on track for IND in 2026. Our continued financial discipline and business execution position us well as we head into pivotal data readouts and prepare for our first NDA filing for NonAdvSM later this year.” Recent Business Highlights Announced alignment with the U.S. Food and Drug Administration (FDA) on the SUMMIT New Drug Application (NDA) submission plan for broad NonAdvSM patient population following a productive pre-NDA meeting, as well…Read full documentShow less
Phase 3 PEAK results in 2nd-line GIST patients expected in November; pivotal APEX results in AdvSM patients expected in December Breakthrough Therapy Designation granted for bezuclastinib; New Drug Application (NDA) filing for NonAdvSM remains on track for year-end 2025 Multiple bezuclastinib abstracts selected for presentation at the 67th Annual Meeting of the American Society of Hematology (ASH); SUMMIT data in NonAdvSM selected for two oral presentations Plan to showcase novel JAK2 V617F mutant-selective candidate at ASH 2025 Strong pro forma cash position of $430 million expected to fund operations through anticipated launch of bezuclastinib and into 2027 WALTHAM, Mass. and BOULDER, Colo., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported recent business highlights and financial results for the third quarter ended September 30, 2025. “Cogent had a very productive and busy third quarter and we now find ourselves weeks away from reporting top-line results from our Phase 3 PEAK trial of bezuclastinib plus sunitinib in Gastrointestinal Stromal Tumor (GIST) patients and our registration-directed APEX trial in Advanced Systemic Mastocytosis (AdvSM) patients. In addition, we are pleased to announce we will have three bezuclastinib presentations at ASH 2025, including two oral presentations focused on the results from the SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “On top of this progress, we recently presented updated preclinical data from our research pipeline that demonstrated potential best-in-class attributes of our pan-KRAS inhibitor and plan to describe for the first time at ASH 2025 our highly potent, highly selective JAK2 V617F mutant-selective inhibitor. Both of these programs are on track for IND in 2026. Our continued financial discipline and business execution position us well as we head into pivotal data readouts and prepare for our first NDA filing for NonAdvSM later this year.” Recent Business Highlights Announced alignment with the U.S. Food and Drug Administration (FDA) on the SUMMIT New Drug Application (NDA) submission plan for broad NonAdvSM patient population following a productive pre-NDA meeting, as well as the receipt of Breakthrough Therapy Designation for bezuclastinib in NonAdvSM patients previously treated with avapritinib and in patients with Smoldering Systemic Mastocytosis; populations with no currently approved standard of care. Reported positive top-line results from SUMMIT evaluating bezuclastinib in patients with NonAdvSM, achieving statistical significance across all primary and key secondary endpoints. Announced multiple presentations have been accepted at the 67th Annual Meeting of the American Society of Hematology (ASH) being held December 6-9, 2025, in Orlando, FL, including two SUMMIT oral presentations and a poster presentation on Cogent’s novel JAK2 V617F mutant-selective inhibitor, the company’s newest discovery stage program. Details of the ASH presentations can be found in a separate release issued today. Recently received clearance from the FDA on Cogent’s Investigational New Drug (IND) submission for CGT4255, a novel, selective, potent, CNS-penetrant ErbB2 inhibitor. A Phase 1 dose escalation trial is on track to initiate in November. In July, successfully closed an upsized underwritten public offering of 25,555,556 shares of common stock at $9.00 per share, including the full exercise of the underwriters’ option to purchase an additional 3,333,333 shares. This offering generated net proceeds of $215.8 million. Cogent also recently raised $39 million through targeted share sales via the Company’s at-the-market facility (ATM). Anticipated Upcoming Milestones Announce top-line results from PEAK in November 2025. PEAK is a global, randomized Phase 3 clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant GIST. Announce top-line results from APEX in December 2025. APEX is a registration-directed, global, open-label trial in patients with AdvSM. Submit Cogent’s first NDA for bezuclastinib by the end of 2025. Third Quarter 2025 Financial Results Cash Position: As of September 30, 2025, cash, cash equivalents and marketable securities were $390.9 million, as compared to $345.5 million as of June 30, 2025. The company believes that its cash, cash equivalents and marketable securities, together with the $39.0 million gross proceeds from shares sold through the ATM since last quarterly filing, will be sufficient to fund its operating expenses and capital expenditure requirements into 2027, including through potential FDA approval of bezuclastinib for NonAdvSM and early commercial launch activities. R&D Expenses: Research and development expenses were $69.0 million for the third quarter of 2025 as compared to $63.6 million for the third quarter of 2024. The increase was primarily due to costs incurred to support our on-going SUMMIT, PEAK and APEX clinical trials and to the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $5.4 million for the third quarter of 2025 compared to $4.8 million for the third quarter of 2024. G&A Expenses: General and administrative expenses were $14.4 million for the third quarter of 2025 as compared to $11.8 million for the third quarter of 2024. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $5.2 million for the third quarter of 2025 compared to $5.6 million for the third quarter of 2024. Net Loss: Net loss was $80.9 million for the third quarter of 2025 as compared to a net loss of $70.6 million for the same period of 2024. Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Cogent also announced today that on October 22, 2025, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grant of “inducement” equity awards to five new employees under the company’s 2020 Inducement Plan with a grant date of November 3, 2025. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, nonqualified options to purchase 89,500 shares of Cogent common stock. Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a four-year vesting schedule with 25% vesting on the one-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. About Cogent Biosciences, Inc. Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. In addition to bezuclastinib, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases initially targeting mutations in FGFR2/3, ErbB2, PI3Kα, KRAS and JAK2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: plans to present top-line results from the company’s PEAK trial in November 2025; plans to present top-line results from the company’s APEX trial in December 2025; the company’s plans to file an NDA for NonAdvSM before the end of 2025; expectations that the company’s cash is sufficient to fund operations through anticipated commercial launch and into 2027; the best-in-class potential of the company’s pan-KRAS inhibitor; the company’s plans to file INDs in 2026 for both of its KRAS and JAK2 programs; the company’s expectation that bezuclastinib will be approved by the FDA for commercial use for patients with NonAdvSM; and the company’s plans to initiate a Phase 1 trial for its ErbB2 program before the end of 2025. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof. Contact: Christi Waarich Senior Director, Investor Relations [email protected] 617-830-1653
Investor releaseQuarter not tagged2025-08-05Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2025 Financial Results
GlobeNewswire
Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2025 Financial Results
Reported positive top-line results from SUMMIT evaluating bezuclastinib in patients with NonAdvanced Systemic Mastocytosis, achieving statistical significance across all primary and key secondary endpoints On track to share pivotal trial results from PEAK in GIST and APEX in AdvSM in 2H 2025 $453 million in pro-forma cash sufficient to fund operations through anticipated launch and into 2027; includes proceeds from upsized $230 million public offering in July 2025 WALTHAM, Mass. and BOULDER, Colo., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the second quarter ended June 30, 2025. “We were thrilled to announce bezuclastinib’s impressive performance in the SUMMIT trial, demonstrating clinically meaningful and statistically significant results across all primary and key secondary endpoints,” said Andrew Robbins, the Company’s President and Chief Executive Officer. “These positive data along with the favorable safety profile give us confidence that bezuclastinib has the potential to become the new standard-of-care for NonAdvSM patients. Supported by our recent upsized public offering, Cogent is advancing our mission from a position of strength as we prepare to report top-line results from two additional pivotal trials in GIST and AdvSM in the second half of this year, submit our first New Drug Application by the end of 2025 and make continued progress toward the anticipated commercial launch of bezuclastinib in 2026.” Recent Business Highlights Announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients. The SUMMIT trial, which was designed to assess the clinical benefit of bezuclastinib versus placebo, achieved its primary endpoint with a highly statistically significant difference in the mean change in Total Symptom Score (TSS) at 24 weeks (p=0.0002). TSS was assessed by the Mastocytosis Symptom Severity Daily Diary (MS2D2). The bezuclastinib arm had a mean reduction of 24.3 points in TSS at 24 weeks, versus the placebo arm which had a mean reduction of 15.4 points in TSS, resulting in a placebo-adjusted TSS improvement of 8.91 points. In addition, the SUMMIT trial demonstrated highly statistical…Read full documentShow less
Reported positive top-line results from SUMMIT evaluating bezuclastinib in patients with NonAdvanced Systemic Mastocytosis, achieving statistical significance across all primary and key secondary endpoints On track to share pivotal trial results from PEAK in GIST and APEX in AdvSM in 2H 2025 $453 million in pro-forma cash sufficient to fund operations through anticipated launch and into 2027; includes proceeds from upsized $230 million public offering in July 2025 WALTHAM, Mass. and BOULDER, Colo., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today reported financial results for the second quarter ended June 30, 2025. “We were thrilled to announce bezuclastinib’s impressive performance in the SUMMIT trial, demonstrating clinically meaningful and statistically significant results across all primary and key secondary endpoints,” said Andrew Robbins, the Company’s President and Chief Executive Officer. “These positive data along with the favorable safety profile give us confidence that bezuclastinib has the potential to become the new standard-of-care for NonAdvSM patients. Supported by our recent upsized public offering, Cogent is advancing our mission from a position of strength as we prepare to report top-line results from two additional pivotal trials in GIST and AdvSM in the second half of this year, submit our first New Drug Application by the end of 2025 and make continued progress toward the anticipated commercial launch of bezuclastinib in 2026.” Recent Business Highlights Announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients. The SUMMIT trial, which was designed to assess the clinical benefit of bezuclastinib versus placebo, achieved its primary endpoint with a highly statistically significant difference in the mean change in Total Symptom Score (TSS) at 24 weeks (p=0.0002). TSS was assessed by the Mastocytosis Symptom Severity Daily Diary (MS2D2). The bezuclastinib arm had a mean reduction of 24.3 points in TSS at 24 weeks, versus the placebo arm which had a mean reduction of 15.4 points in TSS, resulting in a placebo-adjusted TSS improvement of 8.91 points. In addition, the SUMMIT trial demonstrated highly statistically significant benefit across all key secondary endpoints, including reduction of serum tryptase on which 87.4% of bezuclastinib-treated patients had ≥50% reduction, compared to no patients in the control arm (87.4% vs. 0%; p<0.0001). Bezuclastinib demonstrated a favorable safety and tolerability profile in SUMMIT. The majority of treatment emergent adverse events (TEAEs) (98.3% in bezuclastinib arm vs. 88.3% in placebo arm) were of low grade. The most frequent TEAEs reported on bezuclastinib treatment were hair color change (69.5% bezuclastinib vs. 5.0% placebo), altered taste (23.7% bezuclastinib vs. 0% placebo), nausea (22.0% bezuclastinib vs. 13.3% placebo) and ALT/AST elevations (22.0% bezuclastinib vs. 6.6% placebo; >Gr 3, 5.9% vs. 0%). Serious AEs occurred in 4.2% of patients treated with bezuclastinib, compared to 5.0% of patients treated with placebo. Discontinuations due to treatment-related AEs occurred in 5.9% of patients treated with bezuclastinib, all due to ALT/AST elevations and all patients fully resolved. There were no hepatic AEs reported in any patient other than transient and manageable lab abnormalities. Announced two financial transactions, positioning Cogent with access to over $800 million in capital. In June, secured a debt financing facility of up to $400 million with SLR Capital Partners. An initial tranche of $50 million was drawn at closing in June 2025, with additional tranches available upon achieving key clinical and commercial milestones. In July, successfully closed an upsized underwritten public offering of 25,555,556 shares of common stock at $9.00 per share, including the full exercise of the underwriters’ option to purchase an additional 3,333,333 shares. This offering generated net proceeds of $215.8 million. Anticipated Upcoming Milestones Announce top-line results from PEAK in the second half of 2025. PEAK is a global, blinded, randomized Phase 3 clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant gastrointestinal stromal tumors (GIST). Announce top-line results from APEX in the second half of 2025. APEX is a registration-directed, global, open-label trial in patients with advanced systemic mastocytosis (AdvSM). Submit Cogent’s first NDA for bezuclastinib by the end of 2025. Second Quarter 2025 Financial Results Cash Position: As of June 30, 2025, Cogent had cash, cash equivalents and marketable securities of $237.8 million. The company expects its existing cash, cash equivalents and marketable securities, together with the net proceeds from the $230 million upsized public offering in July 2025, will be sufficient to fund its operating expenses and capital expenditure requirements into 2027, including through potential FDA approval of bezuclastinib for NonAdvSM and early commercial launch activities. R&D Expenses: Research and development expenses were $62.2 million for the second quarter of 2025 as compared to $54.3 million for the second quarter of 2024. The increase was primarily due to costs incurred to support our on-going SUMMIT, PEAK and APEX clinical trials and to the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $5.0 million for the second quarter of 2025 as compared to $4.7 million for the second quarter of 2024. G&A Expenses: General and administrative expenses were $13.4 million for the second quarter of 2025 as compared to $10.1 million for the second quarter of 2024. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $4.8 million for the second quarter of 2025 as compared to $5.3 million for the second quarter of 2024. Net Loss: Net loss was $73.5 million for the second quarter of 2025 as compared to a net loss of $59.0 million for the same period of 2024. Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Cogent also announced today that, on July 30, 2025, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of “inducement” equity awards to six new employees under the company’s 2020 Inducement Plan with a grant date of August 4, 2025. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, nonqualified options to purchase 172,450 shares of Cogent common stock. Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a four-year vesting schedule with 25% vesting on the one-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. About Cogent Biosciences, Inc. Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2/3 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the company’s expectation to report top-line results from both PEAK and APEX in the second half of 2025; the potential for bezuclastinib to become the new standard of care for NonAdvSM patients; the company’s expectation to submit its first NDA by the end of 2025; the anticipated commercial launch of bezuclastinib in 2026; and the company’s anticipated cash runway into 2027, including through potential FDA approval of bezuclastinib for NonAdvSM and early commercial launch activities. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof. Contact: Christi Waarich Sr. Director, Investor Relations [email protected] 617-830-1653
Investor releaseQuarter not tagged2025-07-07Cogent Biosciences Announces Positive Top-line Results Achieving Statistical Significance Across All Primary and Key Secondary Endpoints from the SUMMIT Trial of Bezuclastinib in Patients with Non-Advanced Systemic Mastocytosis
GlobeNewswire
Cogent Biosciences Announces Positive Top-line Results Achieving Statistical Significance Across All Primary and Key Secondary Endpoints from the SUMMIT Trial of Bezuclastinib in Patients with Non-Advanced Systemic Mastocytosis
-- Patients treated with bezuclastinib showed a superior mean change in total symptom score at 24 weeks (-24.3 points vs. -15.4 points, -8.91 point placebo-adjusted difference; p=0.0002), compared to patients treated with placebo, establishing new benchmarks for placebo-adjusted and absolute symptomatic improvement for this patient population -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden, with 87.4% of patients treated with bezuclastinib achieving at least 50% reduction in serum tryptase compared to 0% of patients treated with placebo -- -- Bezuclastinib demonstrated a favorable safety and tolerability profile supporting chronic use in this patient population -- -- Bezuclastinib NDA submission to FDA expected by end of 2025; strong financial position with $237 million current cash balance and access up to an additional $350 million via recently announced debt facility with SLR Capital Partners -- -- On track to share pivotal trial results from PEAK in GIST and APEX in AdvSM in 2H 2025 -- -- Cogent to host investor conference call and webcast today at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo., July 07, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ: COGT) today announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM) demonstrating clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden. Based on these data, Cogent is on track to submit its first new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvSM by the end of 2025. In addition, Cogent plans to present detailed results from the SUMMIT trial at an upcoming medical meeting later this year. “We have been eagerly awaiting this day and are thrilled to announce bezuclastinib’s performance in the SUMMIT trial, demonstrating clinically meaningful and statistically significant results across all trial endpoints,” said Andrew Robbins, Cogent’s President and CEO. “Our team is already at work on our first New Drug Application for bezuclastinib that we expect to file with the FDA later this year. We are committed to providing bezuclastinib access to the thousa…Read full documentShow less
-- Patients treated with bezuclastinib showed a superior mean change in total symptom score at 24 weeks (-24.3 points vs. -15.4 points, -8.91 point placebo-adjusted difference; p=0.0002), compared to patients treated with placebo, establishing new benchmarks for placebo-adjusted and absolute symptomatic improvement for this patient population -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden, with 87.4% of patients treated with bezuclastinib achieving at least 50% reduction in serum tryptase compared to 0% of patients treated with placebo -- -- Bezuclastinib demonstrated a favorable safety and tolerability profile supporting chronic use in this patient population -- -- Bezuclastinib NDA submission to FDA expected by end of 2025; strong financial position with $237 million current cash balance and access up to an additional $350 million via recently announced debt facility with SLR Capital Partners -- -- On track to share pivotal trial results from PEAK in GIST and APEX in AdvSM in 2H 2025 -- -- Cogent to host investor conference call and webcast today at 8:00 a.m. ET -- WALTHAM, Mass. and BOULDER, Colo., July 07, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (NASDAQ: COGT) today announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial of bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM) demonstrating clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden. Based on these data, Cogent is on track to submit its first new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvSM by the end of 2025. In addition, Cogent plans to present detailed results from the SUMMIT trial at an upcoming medical meeting later this year. “We have been eagerly awaiting this day and are thrilled to announce bezuclastinib’s performance in the SUMMIT trial, demonstrating clinically meaningful and statistically significant results across all trial endpoints,” said Andrew Robbins, Cogent’s President and CEO. “Our team is already at work on our first New Drug Application for bezuclastinib that we expect to file with the FDA later this year. We are committed to providing bezuclastinib access to the thousands of patients with Non-Advanced Systemic Mastocytosis as quickly as possible, including through our recently announced Bezuclastinib Expanded Access Program.” The SUMMIT trial, which was designed to assess the clinical benefit of bezuclastinib versus placebo, achieved its primary endpoint with a highly statistically significant difference in the mean change in total symptom score (TSS) at 24 weeks (p=0.0002). TSS was assessed by the Mastocytosis Symptom Severity Daily Diary (MS2D2). The bezuclastinib arm had a mean reduction of 24.3 points in TSS at 24 weeks, versus the placebo arm which had a mean reduction of 15.4 points in TSS, resulting in a placebo-adjusted TSS improvement of 8.91 points. In addition, the SUMMIT trial demonstrated highly statistically significant benefit across all key secondary endpoints, including reduction of serum tryptase on which 87.4% of bezuclastinib-treated patients had ≥50% reduction, compared to no patients in the control arm (87.4% vs. 0%; p<0.0001). “People living with NonAdvSM experience debilitating symptoms with enormous impact on their physical and psychological quality of life,” said Nathan Boggs, MD, PhD, Allergy Division Director, Uniformed Services University, Walter Reed National Military Medical Center. “It is extremely encouraging to see the results of the SUMMIT trial, which match my own experience treating patients with bezuclastinib, as these results suggest there will soon be a new standard of care available for this patient population with significant unmet medical need.” All primary and secondary endpoints demonstrated statistically significant comparisons in favor of bezuclastinib over placebo: The majority of treatment emergent adverse events (TEAEs) (98.3% in bezuclastinib arm vs. 88.3% in placebo arm) were of low grade. The most frequent TEAEs reported on bezuclastinib treatment were hair color change (69.5% bezuclastinib vs. 5.0% placebo), altered taste (23.7% bezuclastinib vs. 0% placebo), nausea (22.0% bezuclastinib vs. 13.3% placebo) and ALT/AST elevations (22.0% bezuclastinib vs. 6.6% placebo; ≥Gr 3, 5.9% vs. 0%). Serious AEs occurred in 4.2% of patients treated with bezuclastinib, compared to 5.0% of patients treated with placebo. Discontinuations due to treatment-related AEs occurred in 5.9% of patients treated with bezuclastinib, all due to ALT/AST elevations and all patients fully resolved. There were no hepatic AEs reported in any patient other than transient and manageable lab abnormalities. “In addition to its impressive effects on improving patient symptoms, the safety and tolerability profile of bezuclastinib is very attractive for a patient population anticipating taking this disease-modifying agent on a chronic basis,” said Lindsay Rein, MD, Associate Professor of Medicine in the Division of Hematologic Malignancies and Cellular Therapy, Duke University. “I am excited to see these top-line results from the SUMMIT trial as bezuclastinib represents a new, powerful treatment option for patients with Non-Advanced Systemic Mastocytosis.” Complete analysis of the full SUMMIT Part 2 data are ongoing, and Cogent plans to present detailed results at an upcoming major medical conference later this year. Cogent remains on track to provide top-line results from both PEAK, a Phase 3 trial of bezuclastinib in combination with sunitinib in patients with gastrointestinal stromal tumors (GIST), and APEX, a registration-directed trial of bezuclastinib in advanced systemic mastocytosis (AdvSM) patients, during the second half of 2025. Webcast Information Cogent will host a live webcast today, July 7, 2025 at 8:00 a.m. ET to discuss the top-line data from SUMMIT. The live event will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days. Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Cogent also announced today that, on June 30, 2025, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grant of “inducement” equity awards to three new employees under the company’s 2020 Inducement Plan with grant dates of July 3, 2025 and July 7, 2025. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, nonqualified options to purchase 92,500 shares of Cogent common stock. Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. About Cogent Biosciences, Inc. Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the company’s expectation to submit an NDA to the FDA for bezuclastinib in patients with NonAdvSM by the end of 2025; plans to present top-line results from the PEAK and APEX trials in the second half of 2025; plans to present a detailed data set from the SUMMIT trial at an upcoming medical meeting later in 2025; the potential for bezuclastinib to become a new standard of care for patients with NonAdvSM; and the expectation that bezuclastinib’s safety and tolerability profile support chronic dosing. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Annual Report on Form 10-K filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof. Contact: Christi Waarich Senior Director, Investor Relations [email protected] 617-830-1653
Investor releaseQuarter not tagged2025-05-06Cogent Biosciences Reports First Quarter 2025 Financial Results
GlobeNewswire
Cogent Biosciences Reports First Quarter 2025 Financial Results
Three Registration-Directed Top-line Data Readouts Remain on Track in 2025: SUMMIT in NonAdvanced SM expected in July, APEX in Advanced SM expected in second half of the-year and PEAK in GIST expected by end of year Ended 1Q 2025 with $245.7 million in cash, sufficient to fund operations into late 2026 WALTHAM, Mass. and BOULDER, Colo., May 06, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2025. “The first quarter of 2025 was very productive for Cogent as our team focused on executing across our portfolio in preparation for three transformative data readouts this year. We look forward to reporting top-line results from our registration-directed SUMMIT trial with bezuclastinib in patients with nonadvanced systemic mastocytosis in July, followed later in the year with top-line results from our APEX and PEAK trials,” said Andrew Robbins, the Company’s President and Chief Executive Officer. “While we are preparing for a potential launch of bezuclastinib in 2026, we are also very proud of the progress we have made with our early-stage pipeline, including presentations from four distinct programs recently at the annual AACR conference.” Recent Business Highlights Announced expanded clinical results from the Open Label Extension (OLE) portion of the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2025 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting. Bezuclastinib showed a 65% mean improvement in Total Symptom Score (TSS) at 48 weeks, including 88% of patients achieving at least a 50% reduction in TSS. The safety profile for bezuclastinib remains favorable, with adverse events reported primarily as low-grade and reversible. No treatment-related bleeding or cognitive impairment was observed. The most common treatment-related adverse events were hair discoloration and transient elevations in liver transaminases. All cases of elevated transaminases were asymptomatic and fully reversible. Presented updated preclinical data from the company’s KRAS, PI3Kα, FGFR2/3 and ErbB2 candidates at the American Association of Cancer Research (AACR) an…Read full documentShow less
Three Registration-Directed Top-line Data Readouts Remain on Track in 2025: SUMMIT in NonAdvanced SM expected in July, APEX in Advanced SM expected in second half of the-year and PEAK in GIST expected by end of year Ended 1Q 2025 with $245.7 million in cash, sufficient to fund operations into late 2026 WALTHAM, Mass. and BOULDER, Colo., May 06, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2025. “The first quarter of 2025 was very productive for Cogent as our team focused on executing across our portfolio in preparation for three transformative data readouts this year. We look forward to reporting top-line results from our registration-directed SUMMIT trial with bezuclastinib in patients with nonadvanced systemic mastocytosis in July, followed later in the year with top-line results from our APEX and PEAK trials,” said Andrew Robbins, the Company’s President and Chief Executive Officer. “While we are preparing for a potential launch of bezuclastinib in 2026, we are also very proud of the progress we have made with our early-stage pipeline, including presentations from four distinct programs recently at the annual AACR conference.” Recent Business Highlights Announced expanded clinical results from the Open Label Extension (OLE) portion of the Company’s ongoing SUMMIT trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM) at the 2025 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) meeting. Bezuclastinib showed a 65% mean improvement in Total Symptom Score (TSS) at 48 weeks, including 88% of patients achieving at least a 50% reduction in TSS. The safety profile for bezuclastinib remains favorable, with adverse events reported primarily as low-grade and reversible. No treatment-related bleeding or cognitive impairment was observed. The most common treatment-related adverse events were hair discoloration and transient elevations in liver transaminases. All cases of elevated transaminases were asymptomatic and fully reversible. Presented updated preclinical data from the company’s KRAS, PI3Kα, FGFR2/3 and ErbB2 candidates at the American Association of Cancer Research (AACR) annual meeting. Upcoming Milestones Announce top-line results from SUMMIT in July 2025. SUMMIT is a registration-directed, randomized, double-blind, placebo-controlled, global, multicenter, clinical trial of bezuclastinib in patients with NonAdvSM. Announce top-line results from APEX in the second half of 2025. APEX is a registration-directed, global, open-label trial in patients with advanced systemic mastocytosis (AdvSM). Announce top-line results from PEAK by the end of 2025. PEAK is a global, blinded, randomized Phase 3 clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant gastrointestinal stromal tumors (GIST). First Quarter 2025 Financial Results Cash and Cash Equivalents: As of March 31, 2025, cash, cash equivalents and marketable securities were $245.7 million. During the quarter, the Company sold shares under the Company’s at-the-market (ATM) stock offering for net proceeds of $24.3 million and incurred a non-recurring payment of $9.6 million related to annual performance-based bonus compensation. Based on its current plans, the Company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into late 2026, including through clinical readouts from ongoing SUMMIT, PEAK, and APEX registration-directed trials. R&D Expenses: Research and development expenses were $63.0 million for the first quarter of 2025 compared to $52.7 million for the first quarter of 2024. The increase was primarily due to costs incurred to support our on-going SUMMIT, PEAK and APEX clinical trials and to the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $5.3 million for the first quarter of 2025 as compared to $4.4 million for the first quarter of 2024. G&A Expenses: General and administrative expenses were $11.9 million for the first quarter of 2025 compared to $9.7 million for the first quarter of 2024. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $4.8 million for the first quarter of 2025 as compared to $5.0 million for the first quarter of 2024. Net Loss: Net loss was $72.0 million for the first quarter of 2025 compared to a net loss of $58.3 million for the first quarter of 2024. About Cogent Biosciences, Inc.Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the expectation to report SUMMIT top-line results in July 2025; the expectation to report APEX top-line results in the second half of 2025; the expectation to report PEAK top-line results by the end of 2025; the company’s anticipated cash runway into late 2026; and the potential commercial launch of bezuclastinib in 2026. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Cogent's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof. Contact:Christi WaarichSenior Director, Investor [email protected]

