Core Viewpoint - Cogent Biosciences, Inc. has successfully closed an upsized underwritten public offering of 25,555,556 shares of common stock at a price of $9.00 per share, raising approximately $230 million in gross proceeds [1][2]. Group 1: Offering Details - The offering included 3,333,333 shares from the underwriters' option to purchase additional shares [1] - The net proceeds will be utilized for the development and commercial preparation of bezuclastinib and other product candidates, as well as for working capital and general corporate purposes [2]. - J.P. Morgan, Leerink Partners, and Guggenheim Securities served as joint book-running managers for the offering [2]. Group 2: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with its leading clinical program being bezuclastinib, a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [6]. - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and is developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [6].

Core Viewpoint - Cogent Biosciences, Inc. has announced a public offering of 22,222,223 shares of common stock at a price of $9.00 per share, aiming to raise approximately $200 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 3,333,333 shares on the same terms [1]. - The expected closing date for the offering is around July 10, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for the development, regulatory, and commercial preparation activities related to bezuclastinib and other product candidates [2]. - Funds will also support the planned commercial launch of bezuclastinib, along with working capital and general corporate purposes [2]. Group 3: Company Overview - Cogent Biosciences focuses on developing precision therapies for genetically defined diseases, with bezuclastinib being the most advanced clinical program [5]. - Bezuclastinib is a selective tyrosine kinase inhibitor targeting the KIT D816V mutation, which is associated with systemic mastocytosis and advanced gastrointestinal stromal tumors [5]. - The company is also conducting a Phase 1 study of a novel FGFR2 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [5].

WALTHAM, Mass. and BOULDER, Colo., July 08, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that it has commenced an underwritten public offering of $150 million of its shares of common stock. In addition, Cogent intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of its shares of common stock on the same terms and conditions. All o ...

Core Insights - Bezuclastinib has shown significant clinical benefits in treating patients with non-advanced systemic mastocytosis (NonAdvSM), achieving a statistically significant mean change in total symptom score (TSS) at 24 weeks compared to placebo [1][2][3] - The drug demonstrated a substantial reduction in serum tryptase levels, with 87.4% of patients experiencing at least a 50% reduction, contrasting with 0% in the placebo group [1][2] - Bezuclastinib is expected to submit a New Drug Application (NDA) to the FDA by the end of 2025, supported by a strong financial position with $237 million in cash and access to an additional $350 million [1][2][6] Clinical Trial Results - The SUMMIT trial achieved its primary endpoint with a mean reduction of 24.3 points in TSS for the bezuclastinib group versus 15.4 points for placebo, resulting in a placebo-adjusted improvement of 8.91 points (p=0.0002) [2][3] - All key secondary endpoints also showed statistically significant improvements, including a ≥50% reduction in serum tryptase (p<0.0001) and other measures of mast cell burden [3][4] Safety and Tolerability - Bezuclastinib exhibited a favorable safety profile, with the majority of treatment-emergent adverse events (TEAEs) being low grade; 98.3% in the bezuclastinib arm compared to 88.3% in the placebo arm [4][5] - Common TEAEs included hair color change (69.5% vs. 5.0% placebo), altered taste (23.7% vs. 0%), and nausea (22.0% vs. 13.3%) [4][5] Future Plans - Cogent plans to present detailed results from the SUMMIT trial at an upcoming medical meeting later this year and is on track to share pivotal trial results from the PEAK and APEX trials in the second half of 2025 [1][6][5]

Core Insights - Cogent Biosciences has secured a debt financing facility of up to $400 million to support its growth strategy, including the anticipated launch of bezuclastinib in 2026 [1][2] - The company is on track to report results from three pivotal trials in 2025, starting with the SUMMIT trial results in July [1][4] Financing Details - An initial tranche of $50 million was drawn at closing, with an additional $100 million available in 2025 based on successful data readouts from SUMMIT and PEAK trials [3] - A further $50 million can be accessed upon achieving early commercial success after the bezuclastinib launch, with the remaining $200 million available through mutual agreement [3] Clinical Trials - The SUMMIT trial is a registration-directed, randomized, double-blind, placebo-controlled study focused on patients with NonAdvSM, with results expected in July 2025 [4] - The APEX trial, an open-label study in patients with AdvSM, is set to release results in the second half of 2025, while the PEAK trial results are expected before the end of 2025 [4] Company Overview - Cogent Biosciences specializes in developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation [6] - The company is also advancing a Phase 1 study of a novel FGFR2 inhibitor and developing therapies targeting mutations in ErbB2, PI3Kα, and KRAS [6]

WALTHAM, Mass. and BOULDER, Colo., May 29, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced its presentation at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025 at 7:35 a.m. ET. A live webcast 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 afte ...

Core Viewpoint - Aura Biosciences, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $75 million to support its clinical programs and general corporate purposes [2][3]. Group 1: Offering Details - The public offering consists of 11,735,565 shares of common stock and warrants to purchase 2,933,891 shares of common stock, along with pre-funded warrants for up to 3,571,435 shares at an exercise price of $0.00001 [1]. - The combined offering price for each share of common stock and accompanying warrant is set at $4.90, while the pre-funded warrant and accompanying warrant are priced at $4.89999 [1]. - The offering is expected to close on or about May 16, 2025, subject to customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to advance clinical programs in early-stage choroidal melanoma, metastases to the choroid, cancers of the ocular surface, and non-muscle invasive bladder cancer [3]. Group 3: Company Overview - Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors, with a mission to transform the lives of patients [7]. - The company's lead candidate, bel-sar (AU-011), is in late-stage development for primary choroidal melanoma and early-stage development for other ocular oncology indications and bladder cancer [7]. Group 4: Management and Underwriters - Leerink Partners and Evercore ISI are acting as joint bookrunning managers for the offering, with LifeSci Capital also serving as a bookrunning manager [4]. - Citizens Capital Markets and Scotiabank are co-managers for the offering [4]. Group 5: Regulatory Information - A shelf registration statement for the offering was filed with the SEC on March 27, 2024, and was declared effective on April 5, 2024 [5]. - A preliminary prospectus supplement was filed with the SEC on May 15, 2025, and will be available on the SEC's website [5].

Company Overview - Aura Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors aimed at preserving organ function [5] - The company's lead candidate, bel-sar (AU-011), is in late-stage development for primary choroidal melanoma and early-stage development for other ocular oncology indications and bladder cancer [5] Public Offering Announcement - Aura announced the launch of an underwritten public offering of shares of its common stock, including pre-funded warrants and accompanying warrants [1] - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1] Management and Underwriters - Leerink Partners and Evercore ISI are acting as joint bookrunning managers for the offering, with LifeSci Capital also serving as a bookrunning manager [2] - Citizens Capital Markets and Scotiabank are co-managers for the offering [2] Regulatory Compliance - The offering is made pursuant to a shelf registration statement filed with the SEC on March 27, 2024, and declared effective on April 5, 2024 [3] - A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC and made available on their website [3] Investor Relations - For inquiries, investors can contact Alex Dasalla, Head of Investor Relations and Corporate Communications at Aura [7]

Core Insights - Aura Biosciences, Inc. has initiated a multi-dose Phase 1b/2 trial of bel-sar for Non-Muscle-Invasive Bladder Cancer (NMIBC), with initial data expected by the end of 2025 [1][14] - The company has strengthened its leadership team by appointing Tony Gibney as Chief Financial and Business Officer [1][18] - Aura is making significant progress in its ocular and urologic oncology programs, particularly with the Phase 3 CoMpass trial for early-stage choroidal melanoma [2][3] Recent Pipeline Developments - The CoMpass trial is the first registration-enabling study for early-stage choroidal melanoma, actively enrolling patients globally [3][4] - Over 220 patients have been pre-screened for the CoMpass trial since June 2024, indicating a strong demand for vision-preserving therapies [4] - Bel-sar is also being explored for metastases to the choroid and cancers of the ocular surface, with a collective incidence of over 60,000 patients annually in the U.S. and Europe [6][10] Clinical Trials and Data - A Phase 2 trial for bel-sar in metastases to the choroid has been initiated, with plans to broaden inclusion criteria to include various solid tumors [7] - Positive results from a completed Phase 1 trial for NMIBC showed multiple clinical complete responses and a favorable safety profile [12] - The ongoing Phase 1b/2 trial for NMIBC will evaluate two approaches, with endpoints including complete response rates and recurrence-free survival [13][14] Financial Overview - As of March 31, 2025, Aura reported cash and cash equivalents totaling $128.0 million, sufficient to fund operations into the second half of 2026 [18] - Research and development expenses increased to $23.3 million in Q1 2025 from $17.1 million in Q1 2024, driven by clinical trial costs [19] - The net loss for Q1 2025 was $27.5 million, compared to $19.7 million in Q1 2024, reflecting increased operational expenses [24]

WALTHAM, Mass. and BOULDER, Colo., April 25, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced preclinical data from four pipeline programs during poster sessions at the American Association for Cancer Research (AACR) 2025 Annual Meeting taking place in Chicago. “We welcome the opportunity to present updated results from these programs that represent our exciting pipeline of po ...