St. Genis-Pouilly, France, 28 October 2025 – Step Pharma (“the Company”), the global leader in CTPS1 inhibition for targeted cancer treatment, today announces the appointment of Karen L. Smith, MD, PhD, MBA, LLM as its Chief Medical Officer (CMO) effective immediately.
Dr Smith brings over 25 years of healthcare industry experience, having held various senior executive positions across global pharmaceutical and biotechnology companies including Bristol Myers Squibb, AstraZeneca and Merck. She brings exceptional expertise in clinical development, regulatory affairs and medical leadership. She has successfully overseen more than 100 clinical trials and 20 regulatory approvals across multiple therapeutic areas including oncology, cardiology, dermatology, rare diseases and neuroscience, leading to global launches of small molecules, biologics and devices.
Dr Smith is currently a board member of several public and private biotech companies including Skye Bioscience (NASDAQ: SKYE), and Context Therapeutics (NASDAQ: CNTX). In her previous board roles, Dr Smith helped deliver significant value through seven corporate exits for pre-clinical, clinical-stage, and commercial businesses totalling almost US $20 billion, including most recently, Capstan Tx (acquired by AbbVie in 2025 for $2.1 billion) and Mariana Oncology (acquired by Novartis in 2024 for $1.75 billion).
She received her MD from the University of Warwick, UK, a PhD in oncology from UCLA/University of Western Australia, as well as an MBA from the University of New England, Australia, and an LLM from the University of Salford, UK.
Andrew Parker, Chief Executive Officer, Step Pharma, commented:
“Karen’s passion for innovative medicine and her experience in leading clinical programmes will help to accelerate our mission to transform cancer and blood disorder treatment through our unique approach to CTPS1 inhibition. Her appointment as Chief Medical Officer, combined with our recently completed Series C financing, leaves us strongly positioned to execute our clinical development plans for dencatistat across multiple indications and ultimately deliver improved outcomes for patients.”
Dr Karen Smith, newly appointed Chief Medical Officer, Step Pharma, added:
“I am honoured to join Step Pharma at this point in the Company’s evolution, and excited by the opportunity to advance dencatistat, a first-in-class CTPS1 inhibitor with promising therapeutic potential across multiple indications. Step Pharma’s innovative ‘pipeline in a product’ strategy represents an efficient approach to clinical development that could provide new treatment options to a huge number of patients, and I look forward to applying my clinical development and regulatory experience to help bring this transformative therapy to patients.”
Contacts
Step Pharma
Andrew Parker, Chief Executive Officer
contact@step-ph.com
Media Relations
ICR Healthcare
Amber Fennell, Namrata Taak, Phillip Marriage
T. +44 (0) 20 3709 5700
steppharma@icrhealthcare.com
