Kenai Therapeutics Receives $8M Grant from California Institute for Regenerative Medicine (CIRM) to Advance RNDP-001 for Treatment of Idiopathic Parkinson's Disease

SAN DIEGO, Jan. 5, 2026 /PRNewswire/ -- Kenai Therapeutics, a clinical-stage biotechnology company pioneering next generation approaches to cure neurological conditions, today announced that the California Institute for Regenerative Medicine (CIRM) awarded an $8 million grant to Howard J. Federoff, M.D., Ph.D., Kenai's Co-Founder, Chief Medical Officer, Executive Vice President of Corporate Medicine and Principal Investigator. This funding will support the continued clinical advancement of Kenai's lead program, RNDP-001, an off-the-shelf, allogeneic neuron replacement cell therapy designed to restore motor function by replacing the dopamine-producing neurons lost to idiopathic Parkinson's disease.

"CIRM's funding and ongoing support are instrumental as we advance RNDP-001 at this critical stage of development," said Nick Manusos, Kenai's Chief Executive Officer. "This award reinforces our shared alignment with CIRM to translate regenerative science into therapies that may meaningfully improve the lives of people living with Parkinson's disease and their families."

"RNDP-001 reflects a fundamentally different way of thinking about Parkinson's disease, one that focuses on restoring what is lost rather than managing decline," said Howard J. Federoff, M.D., Ph.D. "By replacing dopaminergic neurons and repairing neuronal circuitry, our approach is designed to restore motor function in patients with Parkinson's disease. CIRM's support represents an important validation of our platform as we advance through clinical trials."

RNDP-001 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in recognition of the urgent need for new treatments for Parkinson's disease. The therapy is currently being investigated in the Phase 1 REPLACE™ clinical trial, an open-label, multi-center study evaluating the safety and tolerability of RNDP-001, as well as brain imaging evidence of cell survival, engraftment and new brain network function, in adult patients with moderate to moderate-severe idiopathic Parkinson's disease. Initial safety, tolerability and brain imaging data from all 12 patients are expected in 2026.

CIRM's CLIN2 program supports regenerative medicine therapies through key stages of clinical development, providing funding to help advance promising treatments toward regulatory approval and patient access.

About Parkinson's Disease

Parkinson's disease is a chronic, progressive neurodegenerative disorder driven by the degeneration of dopamine-producing neurons in the brain, leading to a decline in motor function. People living with Parkinson's experience a range of motor symptoms, including tremor, rigidity and slowed movement, as well as non-motor symptoms such as fatigue, cognitive impairment, mood disorders and sleep problems. As the disease advances, these symptoms increasingly interfere with independence and quality of life. The global impact of Parkinson's disease is growing rapidly, with more than 10 million people affected worldwide, making it the second most common neurodegenerative disease and the most prevalent movement disorder. Current treatment options remain limited to symptom management and do not provide disease-modifying benefit, reinforcing the urgent need for new therapeutic approaches.

About Kenai Therapeutics

Kenai Therapeutics is a clinical-stage biotechnology company pioneering next generation approaches to cure neurological conditions. By leveraging a proprietary, Nobel Prize-winning iPSC platform, Kenai is developing off-the-shelf, allogeneic neuron replacement and gene-modified cell therapies designed to be disease-modifying. Kenai's lead candidate, RNDP-001, is in Phase 1 clinical development for moderate to moderate-severe forms of idiopathic Parkinson's disease. The company's additional programs target inherited and genetically driven subtypes of Parkinson's disease and other neurological conditions, with the goal of delivering long-lasting restoration of function. Kenai's exclusive manufacturing partnership with FUJIFILM Cellular Dynamics, Inc., enables scalable, cryopreserved production of high-potency cell therapies. Founded in 2022, Kenai is backed by leading life science investors and is headquartered in San Diego, CA. For more information, visit www.kenaitx.com and follow us on LinkedIn and Bluesky.

About the California Institute for Regenerative Medicine (CIRM)

CIRM was created by the people of California to fund stem cell and gene therapy research with the goal of accelerating treatments for patients with unmet medical needs. With $8.5 billion in funding allocated through both Proposition 71 in 2004 and Proposition 14 in 2020, CIRM supports stem cell and gene therapy discoveries from inception through clinical trials, trains a workforce in California to fill jobs in the state's thriving biotech and biomedical research industry, and creates infrastructure to make clinical trials accessible for people throughout California. All of CIRM's research, workforce development, and infrastructure programs are designed to benefit the people of California, whose vision created the agency. For more information, visit www.cirm.ca.gov.

SOURCE Kenai Therapeutics/BIOCOM