Proven and Dynamic Commercial Leader Joins to Build Commercialization Strategy and Organization
New Drug Application for Ulcerative Colitis on Track to be Filed in 2025
CONCORD, Mass., June 10, 2025 /PRNewswire/ — Cristcot, a clinical-stage pharmaceutical company advancing innovative therapies for gastrointestinal diseases, today announced the appointment of Richard Kim to the role of Chief Commercial Officer. In this role, Mr. Kim will lead all aspects of planning and execution for commercialization upon FDA approval for the Company’s lead program, a novel hydrocortisone acetate (HCA 90 mg suppository administered with Cristcot’s proprietary Sephure® applicator for patients with ulcerative colitis (UC) of the rectum). This appointment follows Cristcot’s recent topline results from its pivotal Phase 3 CESSA clinical trial.
Mr. Kim is a results driven and respected commercial leader with over 25 years of leadership experience in biopharmaceutical commercialization across the U.S. and global markets. He has successfully led more than a dozen product launches at both large pharmaceutical companies and emerging biotechs, with particular expertise in specialty areas including gastroenterology. He most recently served as Chief Commercial Officer at Avadel Pharmaceuticals, where he oversaw the successful launch of LUMRYZ™ and built the company’s commercial function from the ground up.
“Earlier this year, we shared strong results from our pivotal Phase 3 CESSA study in UC, with subjects achieving clinical response by Day 15 and clinical remission, defined by mucosal healing, by Day 29,” said Jennifer J. Davagian, Founder and Chief Executive Officer, Cristcot. “As we advance our lead asset towards commercialization, including our upcoming NDA submission this year, Richard’s appointment reflects an important inflection point for our company as our focus turns to building our commercial launch capabilities. His deep experience launching innovative therapies and leading high-performing commercial organizations makes him a key addition to our team. With Richard’s appointment, following Jenny Gizzi’s recent appointment as Chief Administrative Officer, we are building a powerhouse leadership team to bring this therapy to patients following FDA approval and scale our organization for the future.”
Mr. Kim added, “Cristcot has already delivered compelling phase 3 clinical results in a therapeutic area with significant unmet need. I’m thrilled to join at this pivotal time to shape the commercial launch strategy and build an exceptional team as we prepare to bring a highly differentiated new treatment option to people living with UC following regulatory approval.”
Mr. Kim previously served as the President of U.S. Commercial & Strategic Marketing at Intercept Pharmaceuticals Inc. where he successfully launched OCALIVA™ (obeticholic acid), the first new treatment in nearly 20 years for Primary Biliary Cholangitis. He also worked at Bristol-Myers Squibb as the General Manager of Worldwide Commercialization where he led the impressive worldwide launch of DAKLINZA™ (daclatasvir) for hepatitis C. He also held other roles including leading large sales teams, U.S. oncology marketing and strategic marketing. Mr. Kim started his biopharmaceutical career at Schering-Plough, which was acquired by Merck & Co., Inc. and held a range of senior positions in the U.S., Canada and Australia. Mr. Kim received his B.S. in Chemistry from the University of Alberta.
About Cristcot’s HCA 90 mg Suppository
Cristcot’s investigational HCA 90 mg 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 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 Concord, Massachusetts.
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
Jenny Gizzi, Chief Administrative Officer
Cristcot
[email protected]
Tanner Kaufman / Shana Marino
FTI Consulting
[email protected] / [email protected]
SOURCE Cristcot
