— Study findings create a framework of protocols for implementing endocrine principles to assess compliance within a clinical trial that can be deployed across medical specialties —

— Building in hypothalamic-pituitary-adrenal (HPA) axis safety monitoring should be considered for all future trials in which steroid therapy could influence patient safety and/or data integrity —

AUSTIN, Texas, July 27, 2026 (GLOBE NEWSWIRE) — Cristcot, a clinical-stage pharmaceutical company advancing targeted therapies for gastrointestinal diseases, today announced that the Company presented its poster with a select oral presentation assessing HPA integrity at the Endocrine Society’s ENDO 2026 Conference on June 14, 2026, in Chicago, Illinois. The ENDO Conference brings together leading clinicians, researchers, and industry experts with a focus on emerging therapies and innovation.

In CESSA, a Phase 3 trial of Cristcot’s investigational next-generation hydrocortisone acetate (ngHCA) 90 mg rectal suppositories for ulcerative colitis (UC) of the rectum, researchers implemented complementary adrenocorticotropic hormone (ACTH) stimulation protocols to identify baseline adrenal disease and treatment-emergent secondary suppression as a part of safety monitoring.

“Adrenal dysfunction and treatment-emergent suppression can be difficult to distinguish in clinical trials. Implementation of known endocrine biological principles to assess safety and study compliance can be useful in the evaluation of study drugs in clinical trials where corticosteroids are a common clinical therapy,” stated Elena A. Christofides, MD, CEO Endocrinology Associates. “Steroids are widely accessible and used broadly across medical specialties, and yet until now, we have never had the ability within a clinical trial to differentiate patients using non-study supplied steroids from those receiving only the study drug. In this study, we showcase that endocrine science can be effectively utilized and applied across specialties, including non-endocrine medical specialties. Appropriate steroid safety monitoring protocols must be considered an essential component in clinical trials.”

“With patient safety always top of mind, we embarked on this comparison project with the goal of establishing known biologic truths to apply to other clinical trials employing steroids, both within gastroenterology and beyond,” stated Jennifer J. Davagian, Cristcot Founder and Chief Executive Officer. “For pharmaceutical companies engaging in clinical trials that may be influenced by steroids, it is critically important that we have a framework in place to plan for safety monitoring and data integrity. We are grateful for the opportunity to share this study with the renowned researchers and scientists at ENDO 2026.”

Details of the presentation are as follows:

Session Type: Poster with a Select Oral Presentation
Title: Dual-dose Cosyntropin Stimulation Testing to Assess HPA-axis Safety and Identify Non-Study Corticosteroid Exposure in a Phase 3 Ulcerative Colitis Trial
Date & Time: June 14, 2026, at 3:30pm CDT
Presenter: Elena A. Christofides, MD, CEO Endocrinology Associates
Co-Author: Mark Ensign, BS, Cristcot

About ngHCA

ngHCA, Cristcot’s investigational hydrocortisone acetate (HCA) 90 mg suppository formulation, is a novel corticosteroid therapy delivering a small volume suppository administered using the Sephure® suppository applicator. Rectally administered topical treatments, including topical corticosteroids, are important treatment options (either alone or in combination with other therapies), for directing delivery to inflammation sites and limiting systemic drug exposure. Unlike other corticosteroid treatments, Cristcot’s advanced HCA formulation allows for rapid, sustained release with optimal bioavailability, and very limited systemic exposure. Cristcot’s innovative delivery system is designed to overcome the treatment barriers associated with currently available therapies and enhance patient compliance. If approved by FDA, ngHCA would be the first and only FDA-approved HCA suppository.

About Ulcerative Colitis (UC)

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 include rectal bleeding, profuse diarrhea, bowel urgency, tenesmus, and abdominal pain significantly impacting patients’ quality of life. UC flares originate in the rectum, and if left untreated, inflammation can progress to more proximal disease and severity, leading to hospitalization or surgery. There is no cure for UC, and breakthrough flares, even while taking maintenance medication, is a known pattern of the disease profile. Over 80% of UC patients experience two 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.

About Cristcot

Cristcot is a clinical-stage pharmaceutical company dedicated to advancing targeted therapies for gastrointestinal diseases. The Company’s lead asset, ngHCA, is positioned to become an important therapeutic option for ulcerative colitis patients. 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 contact us via email or 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). Examples of forward-looking statements include, but are not limited to, statements regarding 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
E: jenny.gizzi@cristcot.com

Investor Relations

Lisa M. Wilson
T: 212-452-2793
E: lwilson@insitecony.com


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