Core Insights - The PEAK trial is the first study to show statistical significance over an active comparator in GIST patients, with the combination of bezuclastinib and sunitinib achieving a median progression-free survival (mPFS) of 16.5 months and an overall response rate (ORR) of 46% in patients previously treated with imatinib [1][2] Group 1: FDA Approval and Clinical Trial Results - The FDA has accepted Cogent Biosciences' New Drug Application (NDA) for bezuclastinib in combination with sunitinib for GIST patients who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program [1][4] - The bezuclastinib combination demonstrated a 50% reduction in the risk of disease progression or death compared to the current standard of care, with a hazard ratio of 0.50 (95% CI: 0.39 – 0.65) [2] - The mPFS for the bezuclastinib combination was 16.5 months compared to 9.2 months for sunitinib monotherapy, and the ORR was 46% for the bezuclastinib combination versus 26% for sunitinib [2] Group 2: Future Plans and Trials - Cogent is expected to initiate the RTOR process immediately, with the completion of the NDA submission anticipated in April 2026 [1][4] - Full results from the PEAK trial will be presented at a major medical meeting in the first half of 2026 [5] - A Phase 2 trial is expected to begin in mid-2026 to investigate the benefit of the bezuclastinib combination for first-line GIST patients with exon 9 mutations who are naive to or have recently started treatment with imatinib [5] Group 3: Company Overview - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation and other mutations in KIT exon 17 [6] - The company is also developing a portfolio of novel targeted therapies aimed at various mutations, including FGFR2/3, ErbB2, PI3Kα, KRAS, and JAK2 [6]

Core Insights - The PEAK trial is the first study to show statistical significance over an active comparator in GIST patients, with the combination of bezuclastinib and sunitinib achieving a median progression-free survival (mPFS) of 16.5 months and an overall response rate (ORR) of 46% in patients previously treated with imatinib [1][2] Group 1: FDA Approval and Clinical Trial Results - The FDA has accepted Cogent Biosciences' New Drug Application (NDA) for bezuclastinib in combination with sunitinib for GIST patients who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program [1][4] - The bezuclastinib combination demonstrated a 50% reduction in the risk of disease progression or death compared to the current standard of care, with a hazard ratio of 0.50 (95% CI: 0.39 – 0.65) [2] - The mPFS for the bezuclastinib combination was 16.5 months compared to 9.2 months for sunitinib monotherapy, and the ORR was 46% for the bezuclastinib combination versus 26% for sunitinib [2] Group 2: Safety and Future Plans - The bezuclastinib combination was generally well tolerated, with no unique risks observed compared to the known safety profile of sunitinib [3] - Cogent plans to present full results from the PEAK trial at a major medical meeting in the first half of 2026 and will initiate a Phase 2 trial in mid-2026 for first-line GIST patients with exon 9 mutations [5][8] Group 3: Company Overview - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with bezuclastinib being a selective tyrosine kinase inhibitor targeting the KIT D816V mutation and other mutations in KIT exon 17 [6] - The company is also developing a portfolio of targeted therapies aimed at various mutations, including FGFR2/3, ErbB2, PI3Kα, KRAS, and JAK2 [6]

Core Insights - The presentation is part of the 44th Annual JPMorgan Healthcare Conference, featuring Cogent Biosciences and its CEO, Andy Robbins [1] - The focus of the discussion is on the future of Cogent, particularly looking ahead to developments in 2026 and beyond [3] Company Overview - Cogent's lead asset, bezuclastinib, is a potent and selective KIT mutant inhibitor [3] - In 2025, Cogent reported positive results from three pivotal trials for bezuclastinib, marking a significant year for the company and its patients [3]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Cogent Biosciences FY Conference Summary Company Overview - **Company**: Cogent Biosciences (NasdaqGS:COGT) - **Lead Asset**: Bezuclastinib, a potent and selective KIT mutant inhibitor - **Focus**: Treatment of gastrointestinal stromal tumors (GIST) and systemic mastocytosis Key Points Industry and Market Opportunity - **Market Size**: The combined annual opportunity for non-advanced systemic mastocytosis and advanced systemic mastocytosis is approximately **$8 billion** [5] - **Competition**: Limited competition exists, primarily from Sanofi's Ayvakit for systemic mastocytosis and no competition in second-line GIST [5][10] - **Second-Line GIST Market**: Expected to be a **$4 billion** market with about **6,000 patients** annually becoming resistant to imatinib [10] Clinical Trials and Regulatory Submissions - **Pivotal Trials**: Three pivotal trials for bezuclastinib were positive in 2025, leading to NDA submissions: - **SUMMIT**: Non-advanced systemic mastocytosis (NDA submitted December 2025) - **PEAK**: GIST (NDA expected in April 2026) - **APEX**: Advanced systemic mastocytosis (NDA to follow PEAK) [2][3] - **Expected Launch**: Anticipated launch in the U.S. in the second half of 2026 for at least the non-advanced systemic mastocytosis indication [3] Financial Position - **Cash Reserves**: Approximately **$900 million** on the balance sheet, providing a cash runway into 2028 [4] - **Profitability Outlook**: Positioned to discuss profitability based on the timing of commercializations [4] Intellectual Property - **Patent Protection**: Strong intellectual property position with protection extending into the mid-2040s, including composition of matter and formulation patents [6][7] Clinical Efficacy - **GIST Trial Results**: - **Median Progression-Free Survival**: **16.5 months** - **Objective Response Rate**: Nearly **50%**, significantly higher than historical drugs [8][9] - **Symptomatic Improvement**: Notable improvements in overall symptoms and mast cell burden in systemic mastocytosis patients [11][12] Commercial Strategy - **Commercial Organization**: Building a team of approximately **100 employees** focused on access and patient community engagement [22][23] - **Expanded Access Program**: Ongoing program to provide access to bezuclastinib for patients, enhancing experience prior to full commercial launch [21] Future Developments - **Pipeline Expansion**: Plans to initiate trials for additional indications, including first-line GIST and combination therapies [18][19] - **New Assets**: Development of a selective JAK2 V617F inhibitor and a pan-KRAS inhibitor, with IND filings expected in 2026 [25][26] Pricing Strategy - **Benchmarking**: Pricing will be informed by existing KIT inhibitors, with current benchmarks around **$41,000 to $46,000** per month [39][40] International Expansion - **Partnerships**: Actively exploring partnerships for commercialization outside the U.S., particularly in Europe and other regions [41][42] Conclusion Cogent Biosciences is positioned for significant growth with its lead asset, bezuclastinib, targeting substantial market opportunities in rare diseases. The company is on track for multiple NDA submissions and a potential launch in 2026, backed by a strong financial position and a robust clinical pipeline.

J.P. Morgan Annual Meeting January 13, 2026 Forward-Looking Statements and Risk Factors This presentation and the accompanying oral commentary contain forward-looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward looking statements. All statements other than statements of historical fact could be deemed forward-looking, including ...

Core Insights - Cogent Biosciences, Inc. is poised for significant advancements in 2026, focusing on the commercialization of bezuclastinib and expanding its pipeline of targeted therapies [2][6][11] Milestones for 2026 - The company plans to launch bezuclastinib in the second half of 2026, following the submission of multiple New Drug Applications (NDAs) for various indications [2][6][7] - An NDA for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) was submitted in December 2025, with acceptance expected by the end of February 2026 [6][7] - An NDA for bezuclastinib in Advanced Gastrointestinal Stromal Tumors (GIST) is on track for submission in April 2026, potentially marking the first new therapy for second-line GIST in over 20 years [6][7] - Clinical data from pivotal trials (SUMMIT, PEAK, APEX) will be presented at major medical meetings in the first half of 2026 [6][7] Financial Position - Cogent enters 2026 with approximately $900 million in cash, which is expected to fund commercial launches and operations well into 2028 [6][7] Leadership and Team - Abb Hayden has been appointed as Senior Vice President of Sales, bringing over 25 years of industry experience to the company [8] Expanded Access Programs - The company has established Expanded Access Programs for U.S. patients with GIST or Systemic Mastocytosis, allowing access to bezuclastinib for eligible patients [8]

Core Insights - Cogent Biosciences is poised for significant advancements in 2026, focusing on the commercialization of bezuclastinib and expanding its pipeline of therapies for genetically defined diseases [2][6][11] Milestones and Developments - In 2025, Cogent achieved positive results from pivotal trials of bezuclastinib for GIST and Systemic Mastocytosis, submitted its first NDA for NonAdvSM, and entered 2026 with approximately $900 million in cash [2][6] - The company plans to launch bezuclastinib in the second half of 2026, with NDA submissions for AdvSM and GIST on track for 1H 2026 and April 2026 respectively [6][7] - Clinical data from pivotal trials (SUMMIT, PEAK, APEX) will be presented at major medical meetings in 1H 2026 [6][7] Pipeline Expansion - Cogent is set to submit IND applications in 2026 for its pan-KRAS inhibitor and selective JAK2 V617F inhibitor, alongside ongoing studies for CGT4859 and CGT4255 [6][7][11] - The company is also establishing Expanded Access Programs for bezuclastinib to provide treatment options for eligible patients [5] Leadership and Organizational Changes - Abb Hayden has been appointed as Senior Vice President of Sales, bringing over 25 years of industry experience to the company [8] Presentation and Investor Engagement - Cogent will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, with a live webcast available for investors [9]

Company Overview - Cogent Biosciences specializes in precision therapies for genetically defined diseases, focusing on targeted kinase inhibition and rare mutations [6] - The company's lead product candidate is CGT9486, a selective tyrosine kinase inhibitor targeting KIT D816V and other KIT exon 17 mutations, aimed at treating systemic mastocytosis and advanced gastrointestinal stromal tumors [7] - Cogent operates a precision medicine model with revenue potential linked to successful drug development and commercialization, including licensing agreements [7][8] Transaction Summary - Evan Kearns, the chief legal officer, sold 65,000 shares for a transaction value of $2.52 million, reducing his direct ownership by 37.27% [1][2][10] - Post-transaction, Kearns holds 109,398 shares valued at approximately $4.25 million based on the market close price of $38.70 [2][4][10] - This sale is Kearns's only open-market transaction on record and did not involve any derivatives or indirect interests [10] Market Context - As of December 26, the stock price was $38.70, reflecting a one-year price change of 345.38% [4][9] - The stock's surge followed a public offering announcement in November, which strengthened the balance sheet and reset expectations around clinical milestones [9][11] - The company submitted its first NDA for bezuclastinib in non-advanced systemic mastocytosis, with additional filings planned for 2026 [9]

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgent need for energy to support its growth [1][2][3] Investment Opportunity - A specific company is highlighted as a potential investment opportunity, possessing critical energy infrastructure assets that are essential for meeting the increasing energy demands of AI data centers [3][7] - This company is not a chipmaker or cloud platform but is positioned to benefit significantly from the anticipated surge in electricity demand driven by AI technologies [3][6] Energy Demand and Infrastructure - AI technologies, particularly large language models like ChatGPT, are extremely energy-intensive, with data centers consuming as much energy as small cities [2] - The company in focus is involved in the U.S. LNG exportation sector, which is expected to grow under the current administration's energy policies [7] Financial Position - The company is noted for being debt-free and holding a substantial cash reserve, amounting to nearly one-third of its market capitalization, which positions it favorably compared to other energy firms burdened with debt [8] - It is trading at less than 7 times earnings, indicating a potentially undervalued investment opportunity in the context of its critical role in the energy sector [10] Market Trends - The article discusses the broader trends of onshoring and tariffs that are influencing the energy and manufacturing sectors, suggesting that this company is well-positioned to capitalize on these trends [5][14] - The influx of talent into the AI sector is expected to drive continuous innovation and advancements, further solidifying the importance of energy infrastructure in supporting this growth [12] Conclusion - The company is portrayed as a key player in the intersection of AI and energy, with the potential for significant returns as the demand for AI-driven technologies continues to rise [11][13]