- Weinstein brings more than two decades of experience in life sciences leadership, venture capital, and company building
- Proven track record of guiding innovative healthcare organizations from early-stage development through commercialization
DALLAS, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Gradalis, Inc., a clinical-stage biotechnology company developing personalized anti-cancer therapies, today announced the appointment of Steven D. Weinstein as Chief Executive Officer. Mr. Weinstein brings more than two decades of experience in life sciences leadership, venture capital, and company building. He has a proven track record of guiding innovative healthcare organizations from early-stage development through commercialization with experience spanning strategic financing, clinical development, and operational leadership.
David Shanahan, Gradalis’ Chairman and co-founder stated: “Steve’s deep expertise in oncology, combined with his ability to translate breakthrough science into successful businesses, makes him the ideal leader for Gradalis as we advance our immunotherapy platform. His vision and experience will accelerate our mission to deliver transformative treatments to patients with cancer.”
Steven D. Weinstein, Gradalis’ Chief Executive Officer, stated: “I am honored to join Gradalis at this pivotal moment. Recurrent and resistant solid tumor cancers remain among the greatest challenges in oncology. Gradalis’ strong mechanistic understanding and clear biomarker-driven patient stratification enables a personalized immunotherapy approach with tremendous promise. I look forward to working with this talented team to expand access to our innovative therapies and improve outcomes for patients.”
Overview of experience
Mr. Weinstein brings 20+ years as a life science venture capital investor and company builder. As Managing Director of the Novartis Venture Fund for twelve years, he was actively engaged in all investment decisions across the $800M global portfolio. Prior to Novartis, Steve was on the life science team at Prism Venture Partners, a $1.25B family of funds. He began his venture career as a Kauffman Fellow with Mid-Atlantic Venture Funds.
Mr. Weinstein was CEO of Gregor Diagnostics where he built a leadership team and advanced the R&D and clinical strategy for a novel prostate cancer diagnostic, was Chairman of SpectraWAVE, an interventional cardiology imaging platform that recently announced its acquisition by Philips, from R&D to commercial-stage, and was interim-CEO of Rox Medical (cardiovascular).
He is a member of the Product Development Review Council for the Cancer Prevention and Research Institute of Texas (CPRIT), is an advisor to the UPMC Enterprises Fund, is an Expert-in-Residence to Digitalis Commons supporting ARPA-H’s innovation initiative, and an advisor to the Rockefeller Neuroscience Institute.
He has served as a consultant to Genentech Neuroscience and the American Academy of Ophthalmology. He also served on the Innovation Advisory Board of Mass General Brigham Healthcare.
Steve holds an M.B.A. with distinction from the University of Michigan Business School and a B.S. in mechanical engineering from Columbia University.
About Gradalis, Inc.
Gradalis is a clinical-stage biotechnology company advancing Vigil®, a Phase 3–ready, personalized immunotherapy built on its proprietary bi-shRNA platform. Vigil harnesses the patient’s own tumor clonal neoantigens - without requiring new targets for each indication - to activate the immune system and deliver durable antitumor responses. In the Phase 2 VITAL trial, Vigil demonstrated a statistically significant and clinically meaningful overall survival benefit in ovarian cancer patients who are homologous recombination proficient (HRP, which includes BRCA wild type) and have high clonal tumor mutation burden (cTMB-H). The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Vigil on the basis of these results. HRP status occurs in many solid tumor indications, and combined with cTMB, enables Gradalis to identify the right patients for its therapy. Early clinical experience has shown signs of efficacy across several different solid tumors of high unmet need, underscoring Vigil’s potential for broad use and long-term value creation. Learn more at www.gradalisinc.com.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements regarding the success, cost, and timing of our product development activities and clinical trials, our plans to research, develop, and commercialize our product candidates, and our plans to submit regulatory filings and obtain regulatory approval of our product candidates. These forward-looking statements are based on Gradalis’ current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include but are not limited to: (a) the timing, costs, and outcomes of our clinical trials and preclinical studies, (b) the timing and likelihood of regulatory filings and approvals for our product candidates, and (c) the potential market size for our product candidates. These forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements. This press release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities.
Gradalis Contact
Mark Early
(214) 442-8161
mearly@gradalisinc.com
LifeSci Advisors Contact
Joyce Allaire
+1 (617) 435-6602
jallaire@lifesciadvisors.com
