Biopharma Operations Leader Brings Proven Track Record in Organizational Strategy, Talent, and Growth Enablement
CONCORD, Mass., May 19, 2025 /PRNewswire/ -- Cristcot, a clinical-stage pharmaceutical company advancing innovative therapies for gastrointestinal diseases, today announced the appointment of Jenny Gizzi as Chief Administrative Officer. In this new role, Ms. Gizzi will oversee business operations, including Information Technology (IT), Human Resources (HR), Corporate Standards and Compliance. Ms. Gizzi will focus on building scalable systems to enable cross-functional teams to support Cristcot's continued growth. Her efforts will help as the Company advances its lead therapy, a novel 90 mg hydrocortisone acetate (HCA) suppository administered with the Sephure® suppository applicator for patients with ulcerative colitis (UC) of the rectum, towards FDA regulatory submission and full-scale manufacturing and commercial preparations. This appointment follows Cristcot's recent topline results from its pivotal Phase 3 CESSA clinical trial.
Jenny brings more than 20 years of experience leading strategy, operations, talent acquisition, and infrastructure transformation across both emerging biotech and global pharmaceutical companies. Most recently, she served as Chief People Officer at Elevar Therapeutics, where she led company-wide initiatives across HR, IT, Communications, and Administration Planning in support of the company's first U.S. commercial launch preparations. Her leadership resulted in significant operational efficiencies, cost savings, and the implementation of a scalable strategy aligned to the company's mission and growth trajectory.
"We are thrilled to welcome Jenny to the Cristcot team as we continue to build on the momentum from our positive Phase 3 results. Her work will enhance the build out of our commercial business operations and scaled manufacturing capabilities as we continue to work on our other products in development," said Jennifer Davagian, Founder and CEO of Cristcot. "Jenny has a unique combination of strategic insight, operational discipline, and leadership expertise, coupled with a strong track record of guiding companies through growth and transformation. As we continue to advance our pipeline and expand our Company in preparation for commercialization, her expertise will be instrumental as we recruit accomplished individuals and implement the systems and structure needed to support both near-term execution and long-term success."
"I am excited to be joining Cristcot at such a pivotal moment in the Company's journey, moving from clinical operations to pre-commercial planning for a successful future," added Jenny. "Cristcot has made meaningful advances in its product development and scientific research and is poised to move swiftly to build the capabilities needed to deliver on its mission to patients. I look forward to working with the leadership team to strengthen the Company's operational structure, ensure the right standards are in place and adhered to, and the infrastructure support is well established to enable sustained success."
Ms. Gizzi previously held senior roles at Arena Pharmaceuticals, Bristol-Myers Squibb, Illumina, and Mirati Therapeutics. Her career spans strategic leadership in global talent, business operations, and large-scale transformation across commercial, R&D, and enterprise functions. She holds a BA in Corporate Communications from Fairleigh Dickinson University.
About Cristcot's HCA Suppository
Cristcot's investigational HCA suppository formulation is a novel therapy delivered using the Sephure® suppository applicator, the small-volume suppository ensures precise placement, minimizing discomfort and leakage. This innovative delivery system may likely enhance patient compliance. Unlike traditional corticosteroid treatments, the suppository's differentiated mechanism of action allows for rapid release and localized efficacy, reducing systemic exposure.
In January 2025, the Company announced positive Phase 3 data from its pivotal CESSA trial, which met its primary and secondary endpoints, achieving a clinical response by Day 15 and clinical remission by Day 29 in patients with ulcerative colitis (UC) of the rectum.
About Ulcerative Colitis
UC is a life-long, chronic gastrointestinal autoimmune disease characterized by inflammation and ulcers in the lining of the large intestine, including the rectum and sometimes, all or part of the colon. Symptoms often include rectal bleeding, profuse diarrhea, bowel urgency, tenesmus, and abdominal pain significantly impacting patients' quality of life. UC flares originate in the rectum, and untreated inflammation can progress to more extensive disease, leading to hospitalization or surgery. There is no cure for UC and, breakthrough flares, even while taking maintenance medication, is a known characteristic of the disease profile. Over 55% of UC patients experience 3-5 flares annually, with many reporting debilitating effects on daily activities, work, and mental health. Despite existing treatments, patients experience intermittent flares and often change therapies as a measure to treat increased disease activity. The time of transition between one treatment to another is further complicated while waiting for the new therapy to reach full efficacy potential. Gaps remain in addressing flares quickly and effectively, highlighting the need for targeted therapies that can provide rapid symptom relief and remission.
About Cristcot
Cristcot is a clinical-stage pharmaceutical company dedicated to advancing targeted therapies for gastrointestinal diseases. The Company's lead asset, a novel hydrocortisone acetate suppository, is positioned to become the first line therapy for ulcerative colitis. Cristcot's diversified pipeline includes investigational development programs for ulcerative colitis, acute pancreatitis, hemorrhoid disease and other inflammatory gastrointestinal indications with an emphasis on innovative, patient-centric solutions. The company is headquartered in Austin, Texas.
For more information, please visit www.cristcot.com and connect with us on LinkedIn.
Forward-Looking Statements
Certain information set forth in this press release contains "forward-looking information", including "future-oriented financial information" and "financial outlook", under applicable securities laws (collectively referred to herein as forward-looking statements). Example of forward-looking statements include, but are not limited to, the (i) projected financial performance of the Company; (ii) market prospects and potential future sales for the Company products; (iii) expected development of the Company's products, business and projects; (iv) availability of competing products in the market; (v) prospects for regulatory approval of the Company's products; (vi) execution of the Company's vision and growth strategy; and (vii) availability of protections under applicable intellectual property laws.
These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this press release are based upon what management of the Company believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
Contacts
Mark C. Ensign, COO/CSO
Cristcot
info@cristcot.com
Tanner Kaufman / Shana Marino
FTI Consulting
tanner.kaufman@fticonsulting.com / shana.marino@fticonsulting.com
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SOURCE Cristcot
