Paulex Bio Receives NIH Fast-Track Grant to Advance Beta Cell Regeneration Therapy of PAL-119

PAL-119 is designed to regenerate and restore insulin-producing pancreatic beta cells as a potential disease-modifying therapy for Type 1 and Type 2 diabetes

SAN DIEGO, Nov. 10, 2026 /PRNewswire/ -- Paulex Bio Inc., a biopharmaceutical company focused on rebuilding the body's own insulin-producing capacity, today announced that it received a Fast-Track Small Business Technology Transfer (STTR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH), to advance the development of PAL-119 as a potential treatment for Type 1 and Type 2 diabetes. PAL-119 is an investigational oral small molecule designed to regenerate insulin-producing beta cells and restore their ability to release insulin in response to glucose.

Awarded following competitive peer review, the NIH Fast-Track grant supported Phase I preclinical development of PAL-119 and provides a potential pathway to Phase II funding, subject to achievement of project milestones and NIH approval.

"Receipt of this competitive NIH grant is validation of the science behind PAL-119 and its potential to address beta cell loss and dysfunction, a central biological driver of both Type 1 and Type 2 diabetes," said Miguel Sanjuan, Ph.D., Co-Founder, President and CEO of Paulex Bio and principal investigator on the grant. "As we advance PAL-119 into a first-in-human clinical trial, our mission is to change the course of diabetes treatment by introducing a disease-modifying therapy that offers the potential to both regenerate insulin producing beta cells and restore their function."

PAL-119 is currently being investigated in a Phase 1/2a clinical trial (NCT07901595) in Australia. The study will evaluate the safety, tolerability, pharmacokinetics and exploratory pharmacodynamic effects of PAL-119 in healthy volunteers and adults with Type 1 or Type 2 diabetes, including C-peptide as a marker of endogenous insulin production.

About PAL-119
PAL-119 is an investigational, dual-action oral small molecule designed to regenerate and restore the function of insulin-producing beta cells, with potential applications in Type 1 and Type 2 diabetes. Originating from research at the Icahn School of Medicine at Mount Sinai, PAL-119 is designed to promote beta cell regeneration by inhibiting dual-specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A), an enzyme that limits beta cell replication. PAL-119 has also shown the ability in preclinical studies to enhance beta cell function through protein kinase A (PKA) signaling, which supports glucose sensing and insulin secretion. PAL-119 was engineered with improved target selectivity and substantially reduced brain exposure compared with harmine.

About Paulex Bio
Paulex Bio Inc. is a biopharmaceutical company focused on changing the course of diabetes by addressing the biological cause of the disease. Its lead candidate, PAL-119, is an investigational oral small molecule designed to regenerate and restore the function of insulin-producing beta cells, with potential applications in Type 1 and Type 2 diabetes. Paulex holds exclusive worldwide rights from the Icahn School of Medicine at Mount Sinai to PAL-119 and related compounds, including composition-of-matter patent families. For more information, visit www.paulexbio.com.

Forward-Looking Statements
This release contains forward-looking statements regarding Paulex Bio's research and development programs, including the potential benefits of its investigational therapies and the timing, progress and results of clinical trials. These statements reflect current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including risks related to clinical development, regulatory requirements, financing and the company's ability to advance its programs. Paulex Bio undertakes no obligation to update these statements, except as required by law.

Contacts
Tiberend Strategic Advisors, Inc.

Investor Relations
David Irish / Brooke Cooper
231-632-0002 / 862-274-1134
[email protected] / [email protected]

Media Relations
Casey McDonald / Michelle Katsel
646-577-8520 / 201-790-3390
[email protected] / [email protected] 

SOURCE Paulex Bio Inc.