Hepion Pharmaceuticals Announces Dr. Kaouthar Lbiati as Interim Chief Executive Officer

Rhea-AI Summary

Hepion Pharmaceuticals (OTC:HEPA) has appointed Dr. Kaouthar Lbiati as interim CEO, effective June 16, 2025, replacing retiring John Brancaccio. Dr. Lbiati, who has served on Hepion's Board since 2022, brings over 15 years of global leadership experience in biotech and pharmaceutical companies. The company is repositioning itself as a leader in precision diagnostics, focusing on developing tests for celiac disease, respiratory multiplex testing, H. pylori, and hepatocellular carcinoma (HCC). Dr. Lbiati's extensive experience includes advancing therapies from preclinical development to global commercialization, having contributed to successful launches of treatments like Jevtana, Votrient, Blincyto, Filgotinib, and Symbicort. The company plans to focus on near-term revenue generation through commercialization of CE-marked tests in Europe and UK, while pursuing U.S. regulatory submissions.

Positive

• Dr. Lbiati brings 15 years of global leadership experience in biotech and pharmaceutical companies
• Strategic shift towards precision diagnostics in high-demand clinical areas
• Clear focus on near-term revenue generation through CE-marked tests in Europe and UK
• Dr. Lbiati has proven track record in successful drug commercialization across multiple therapeutic areas

Negative

• Management instability with CEO transition
• Company trading on OTC markets rather than major exchanges
• Regulatory approvals still pending in the U.S. market

MORRISTOWN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (OTC:HEPA), a clinical stage biopharmaceutical company that is developing and commercializing diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma (HCC), today announced that Dr. Kaouthar Lbiati has been named as interim Chief Executive Officer, effective June 16, 2025. Dr. Lbiati is replacing John Brancaccio, who is retiring for personal reasons.

Dr. Lbiati’s appointment signals a new chapter for Hepion—one focused on strategic renewal, value creation, and diagnostic innovation in areas of significant unmet clinical need, including celiac disease, respiratory multiplex testing (COVID-19 / Influenza A & B / RSV), H. pylori, and HCC.

Dr. Lbiati has served on Hepion’s Board of Directors since June 2022 and brings over 15 years of global leadership experience in both biotech and large pharmaceutical companies. She also serves on the board of Theralase Technologies Inc., a publicly traded, clinical-stage oncology company. Throughout her career, Dr. Lbiati has played pivotal roles in advancing innovative therapies from preclinical development to global commercialization across a wide range of therapy areas including regenerative medicine. She has led cross-functional teams, built strategic partnerships, secured regulatory approvals and reimbursement in diverse international markets, and successfully contributed to the launch of breakthrough treatments including Jevtana^®️, Votrient^®️, Blincyto^®️, Filgotinib^®️, and Symbicort^®️, across oncology, hematology, immune-inflammation, respiratory diseases, respectively.

Hepion Board member Dr. Tim Block said “Firstly, I want to thank Mr John Brancaccio for his service as interim CEO. His wisdom was essential in navigating through challenging times and guiding us to new opportunities. I am excited to welcome Dr. Lbiati to the Hepion leadership role. We believe Dr. Lbiati brings the vision, global experience, and strategic clarity needed to guide Hepion through this exciting next phase. The Board is confident in her ability to drive innovation and deliver real-world global impact in diagnostics.”

Dr. Lbiati said "This is a pivotal moment for rebuilding Hepion and redefining its role in the global diagnostics ecosystem. We are repositioning the company as a leader in precision diagnostics, leveraging scalable technologies to address high-demand clinical needs, starting with underdiagnosed conditions like celiac disease, H. pylori, and HCC. Hepion’s transformation is grounded in delivering immediate impact through disciplined execution and rapid commercialization of both CE-marked tests in Europe and the UK, and U.S. regulatory submissions. We plan to prioritize near-term revenue generation and long-term innovation, and clinical utility both for patients at risk of developing liver cancer, and their caregivers (health surveillance)”.

About Hepion Pharmaceuticals

Hepion is a clinical stage biopharmaceutical company that is developing and commercializing diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and hepatocellular carcinoma.

In April 2024, Hepion announced that it was winding down its ASCEND-NASH clinical trial. This trial was designed as a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of Rencofilstat dosed for 12 months, with a target enrollment of 336 subjects. Enrollment was paused in April 2023, with 151 subjects randomized.

On May 26, 2025, Hepion entered into a patent and associated assets acquisition agreement whereby the Company sold all patent assets, knowhow, clinical trial data and drug product relating to Rencofilstat for a nominal amount om addition to a contingent value right (CVR) to Hepion’s stockholders.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission.

For further information, please contact:

Hepion Pharmaceuticals
info@hepionpharma.com

FAQ

Who is the new interim CEO of Hepion Pharmaceuticals (HEPA)?

Dr. Kaouthar Lbiati has been appointed as interim CEO of Hepion Pharmaceuticals, effective June 16, 2025, replacing John Brancaccio who is retiring for personal reasons.

What is Hepion Pharmaceuticals (HEPA) new business focus?

Hepion is repositioning as a leader in precision diagnostics, developing tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), H. pylori, and hepatocellular carcinoma (HCC).

What is Dr. Kaouthar Lbiati's experience before joining HEPA as CEO?

Dr. Lbiati has over 15 years of global leadership experience in biotech and pharmaceutical companies, has served on Hepion's Board since 2022, and has contributed to launching successful treatments including Jevtana, Votrient, Blincyto, Filgotinib, and Symbicort.

What are Hepion Pharmaceuticals' (HEPA) immediate business plans?

The company plans to focus on near-term revenue generation through commercialization of CE-marked tests in Europe and UK, while pursuing U.S. regulatory submissions for their diagnostic tests.

How long has Dr. Lbiati been associated with Hepion Pharmaceuticals (HEPA)?

Dr. Lbiati has served on Hepion's Board of Directors since June 2022 before being appointed as interim CEO in June 2025.