License from UCSF and new NIH funding to UCSF advance first-in-human study of injectable regenerative therapy

FOR IMMEDIATE RELEASE

VAIL, Colo. and SAN FRANCISCO, Calif. — October 19^th, 2026 — Hydronovo, Inc., a biotechnology company developing therapies to regenerate damaged tissues by reactivating stem cells, today announced significant progress toward clinical evaluation of Ceviginate™ (CVGN8), its lead investigational therapy for xerostomia, or chronic dry mouth.

Three milestones move the program from the laboratory to patients:

• Hydronovo's exclusive license from the University of California, San Francisco (UCSF) for human therapeutic use of the underlying regenerative technology.

• $882,081 in continued Phase II SBIR funding from the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health (NIH), supporting drug-product development, manufacturing and regulatory activities.

• A new NIDCR UG3 award to UCSF to prepare for the first-in-human clinical study of CVGN8 in radiation-induced xerostomia, led by radiation oncologist Sue Yom, MD, PhD.

Treating the damage, not just the symptoms

Xerostomia is caused by salivary gland dysfunction and can significantly affect eating, speaking, sleeping, and oral health. It is common among head and neck cancer survivors whose glands were damaged by radiation, and also occurs in Sjögren's disease (an autoimmune condition) and as a side effect of many necessary medications. Current treatments largely relieve symptoms temporarily and do not regenerate damaged tissue.

CVGN8 is an injectable neuromimetic drug product designed to do something different: mimic the nerve-derived signals that maintain salivary gland stem cells, reactivating the gland's own regenerative capacity to restore saliva production. It pairs a regenerative therapeutic agent with a proprietary injectable hydrogel for localized, sustained delivery inside the gland.

The science originated in the UCSF laboratory of co-founder Sarah M. Knox, PhD. The licensed intellectual property was developed by UCSF researchers Dr. Knox and Chelsea S. Bahney, PhD, with collaborators Eben Alsberg, PhD, and Oju Jeon, PhD, supported by NIDCR and the California Institute for Regenerative Medicine (CIRM), and has produced multiple peer-reviewed publications and an expanding international patent portfolio.

The first study in patients

The XERO Study — a Phase I study of CVGN8 for the treatment of radiation-induced xerostomia — will be the first evaluation of CVGN8 in humans. It will be led by Sue Yom, MD, PhD, an internationally recognized head and neck radiation oncologist and clinical investigator.

"Radiation-induced xerostomia remains an important quality-of-life issue for many patients treated successfully for head and neck cancer. This study will allow us to begin evaluating the safety and clinical potential of a regenerative approach designed to address the underlying salivary gland damage rather than simply managing its symptoms," said Sue Yom, MD, PhD, principal investigator of the XERO Study.

Ahead of the interventional trial, UCSF is enrolling patients in the XeroEXP study to understand patient experience. For more information, email [email protected].

"The UCSF license establishes the foundation for Hydronovo to develop this technology, and continued support from NIDCR is enabling us to manufacture and prepare CVGN8 for clinical use," said Chelsea Bahney, PhD, Chief Executive Officer and Co-Founder of Hydronovo. "The path from a biological discovery to a therapy that can be evaluated in patients requires sustained collaboration across basic science, engineering, product development and clinical medicine."

"This is the type of translational pathway we seek to enable at UCSF — bringing together scientific discovery, entrepreneurship and clinical expertise to move promising technologies toward patients," said David Morris, Vice Chancellor, UCSF Innovation Ventures. "Hydronovo's progress with CVGN8 represents an important step toward addressing a significant unmet need for patients living with xerostomia."

About Hydronovo

Hydronovo, Inc. is a biotechnology company developing regenerative therapies designed to restore organ function through stem cell reactivation, addressing underlying tissue damage rather than providing temporary relief. Backed by NIH/NIDCR and CIRM funding, the company's lead product candidate is Ceviginate™ (CVGN8), an injectable neuromimetic drug product being developed to treat xerostomia by promoting regeneration of damaged salivary gland tissue. CVGN8 has not yet been approved by the U.S. Food and Drug Administration. For more information, visit www.hydronovo.com.

About UCSF Innovation Ventures

UCSF Innovation Ventures advances UCSF discoveries by protecting intellectual property, establishing industry partnerships and supporting commercialization. Through licensing and startup formation, UCSF works to translate scientific discoveries into products and therapies that improve human health.

Forward-Looking Statements

This press release contains forward-looking statements regarding Hydronovo's development plans, regulatory strategy, product candidates, and anticipated clinical development and commercialization efforts. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Hydronovo undertakes no obligation to update these forward-looking statements except as required by law.

Media Contacts

Hydronovo: Tim Bahney, Chief Operating Officer, [email protected]

UCSF: Chad Burns, [email protected]