Tucatinib

The appointments of Dr. Karen Smith and Dr. Luke Walker to the Board bring extensive operational and clinical development experience to support corporate and pipeline strategyPHILADELPHIA, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced the appointments of Karen Smith, MD, PhD, MBA, LLM and Luke Walker, MD, to its Board of Directors. “Karen and Luke’s vast experience and proven leadership in the biopharmaceutical industry are tremendous assets for Context at this pivotal stage of our growth," said Martin Lehr, CEO of Context Therapeutics. “Karen’s extensive oncology drug development, regulatory, and strategy experience will be invaluable as Context continues to advance its pipeline. Luke brings an extensive track record in oncology drug development, including recent experience developing T cell engaging bispecific antibodies.” Mr. Lehr continued, “These additions supplement our ongoing effort to build Context into a leading oncology company and advance potential best-in-class T cell engaging bispecifics.” Dr. Karen Smith is a biopharmaceutical thought leader with over 20 years of experience bringing drugs into the clinic and through commercialization. She has been a key contributor to the successful development of multiple approved products in several therapeutic areas, including oncology (Herceptin, Vyxeos), rare disease (Defitelio), cardiology (Irbesartan), dermatology (Voluma, Botox), neuroscience (Abilify) and anti-infectives (Teflaro). Previously, she was Global Head of Research & Development and Chief Medical Officer of Jazz Pharmaceuticals. Earlier in her career, Dr. Smith held senior leadership roles at Allergan, AstraZeneca, and Bristol Myers Squibb. Previously, Dr. Smith served on the Board of Directors of Antares Pharma (acquired by Halozyme for $960 million), Acceleron Pharma (acquired by Merck for $11.5 billion), Mariana Oncology (acquired by Novartis for $1 billion upfront), and Sucampo Pharmaceuticals (acquired by Mallinckrodt for $1.2 billion). Dr. Smith currently serves on the Board of Directors of Aurinia Pharmaceuticals, Capstan Therapeutics, Sangamo Therapeutics, and Skye Bioscience. Dr. Luke Walker has more than 20 years of clinical development experience as both an executive and board member. Most recently, he was the Chief Medical Officer of Harpoon Therapeutics, an oncology-focused biopharmaceutical company where he was responsible for oversight of all aspects of clinical development programs using Harpoon’s TriTAC T-cell engager platform, which was acquired by Merck in 2024 for $680 million. Previously, Dr. Walker was Vice President of Clinical Development at Seagen, where he was the global development lead for Tukysa (tucatinib) through the program’s successful completion of a pivotal registrational trial and successful regulatory approvals. Earlier, Dr. Walker was Senior Vice President of Clinical Development at Cascadian Therapeutics, which was acquired by Seagen in 2018 for $614 million. Dr. Walker began his career as a practicing medical oncologist and hematologist at Providence Regional Medical Center and with the Everett Clinic. Dr. Walker currently serves on the Board of Directors of Zentalis Pharmaceuticals. About Context Therapeutics®Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors. The Company is building an innovative portfolio of clinical-stage T cell engaging bispecific therapeutics, including CTIM-76, a Claudin 6 (CLDN6) x CD3 bispecific antibody, and CT-95, a Mesothelin (MSLN) x CD3 bispecific antibody. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn. Forward-looking StatementsThis press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the ability of the new appointments to support the Company and the advancement of its product candidates; (ii) the ability of the Company to become a leading oncology company; (iii) the potential benefits, characteristics, safety and side effect profile of our product candidates, (iv) the ability of our product candidates to have benefits, characteristics, manufacturability, and a side effect profile that is differentiated and/or better than third party product candidates, (v) the likelihood data will support future development of our product candidates, and (vi) the likelihood of obtaining regulatory approval for our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore cannot assure you that our plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. Investor Relations Contact:Jennifer Minai-AzaryContext TherapeuticsIR@contexttherapeutics.com

413 patients enrolled in PEAK Phase 3 GIST trial, exceeding enrollment target; top-line results expected by end of 2025 PEAK interim futility analysis completed with no changes to study Registration-directed SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) now on track to complete enrollment in Q1 2025; top-line results expected 2H 2025   WALTHAM, Mass. and BOULDER, Colo., Sept. 03, 2024 (GLOBE NEWSWIRE) --  Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided several updates from the company’s ongoing registration-directed clinical trials of its potential best-in-class KIT mutant inhibitor, bezuclastinib. Patient enrollment is now complete in Cogent’s Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib for the treatment of patients with gastrointestinal stromal tumors (GIST). Based on strong global patient interest, a total of 413 patients were enrolled in the study. In addition, Cogent recently completed a pre-planned interim futility analysis, and the Independent Data Monitoring Committee (IDMC) recommended continuing the PEAK study without modification. This pre-specified analysis was based on an assessment of progression-free survival (PFS) as determined by independent central review and did not include the option for early stopping due to efficacy.  Separately, based on significant patient interest in the ongoing SUMMIT trial in nonadvanced systemic mastocytosis (NonAdvSM), Cogent also announced today that it expects to complete enrollment in this study during Q1 2025, approximately three months earlier than originally projected. “We are excited to announce these important updates to the PEAK and SUMMIT studies today,” said Andrew Robbins, Cogent’s President and Chief Executive Officer. “Strong continued interest from patients around the world to participate in our bezuclastinib trials has allowed us to accelerate development and surpass our original enrollment timelines. Completing enrollment in our Phase 3 PEAK trial of bezuclastinib and sunitinib for second-line GIST patients several months ahead of schedule represents a significant milestone for the program and we are extremely grateful to the patients, families, caregivers, advocacy groups and clinical investigators for their participation in, and support of, the PEAK trial.”  PEAK is a randomized, open-label, global Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib alone in GIST patients previously treated with imatinib. The primary endpoint of the trial is median progression free survival (mPFS). PEAK is a registration study intended to support a New Drug Application (NDA) in GIST.  SUMMIT is a randomized, blinded, global, registration-directed clinical trial evaluating bezuclastinib vs. placebo in NonAdvSM patients. The primary endpoint of the trial is mean improvement in patient symptoms measured at 24 weeks. SUMMIT is intended to be a registrational study designed to support a New Drug Application (NDA) in NonAdvSM.  Appointment of Darara Dibabu as Vice President of Marketing In addition to the updates to PEAK and SUMMIT trials, Cogent announced today that Mr. Dibabu has joined Cogent as the VP of Marketing. Mr. Dibabu has 25 years of experience in the biopharmaceutical industry, most recently as the Global Brand Lead of TUKYSA at Pfizer and SeaGen, where he led the global launch and marketing strategy of the product for metastatic breast cancer patients. Previously, he served in various roles of increasing responsibility at Seagen, Bayer and Merck. Mr. Dibabu holds a bachelor's degree in Biology from the University of Southern California. In connection with Mr. Dibabu joining the company, he was granted an “inducement” equity award in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market.  The award was approved by the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, as an inducement material to Mr. Dibabu’s employment. The award consists of nonqualified options to purchase 100,000 shares of Cogent common stock with a 10-year term, at an exercise price of $10.74 per share, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of Mr. Dibabu’s employment and the remainder vesting in equal monthly installments over the subsequent 36 months, provided Mr. Dibabu’s 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, ErbB2 and PI3Kα. 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 expectation to report top-line results from the PEAK trial by the end of 2025, the expectation to complete enrollment in SUMMIT Part 2 in Q1 2025, three months earlier than originally projected, and to report top-line results in the second half of 2025, the potential for bezuclastinib to be a best-in-class KIT mutant inhibitor, the expectation for PEAK to support an NDA in GIST and the intention for SUMMIT to be a registrational study designed to support an NDA in NonAdvSM. 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 christi.waarich@cogentbio.com 617-830-1653