Kenai Therapeutics Announces Completion of Enrollment in Phase 1b/2a REPLACE™ Trial of RNDP-001 in Idiopathic Parkinson's Disease

SAN DIEGO, July 7, 2026 /PRNewswire/ -- Kenai Therapeutics, a clinical-stage biotechnology company pioneering next generation approaches to cure neurological conditions, today announced the completion of enrollment for the REPLACE™ Phase 1b/2a clinical trial of RNDP-001, an investigational cell therapy being developed for the treatment of moderate to moderate-severe idiopathic Parkinson's disease (iPD).

RNDP-001 is an off the shelf, allogeneic neuron replacement cell therapy designed to restore dopaminergic neurons lost in Parkinson's disease. The open label, multi center REPLACE study is assessing safety, tolerability, and preliminary clinical activity of RNDP-001 in the enrolled patient population. The company looks forward to reporting initial safety, tolerability, and efficacy observations from the trial.

"Completing enrollment in the REPLACE trial is an important milestone for Kenai and a meaningful step in advancing our program for patients with Parkinson's disease," said Nick Manusos, Chief Executive Officer of Kenai Therapeutics. "We thank the patients, caregivers, investigators, and clinical site teams for their participation and support in making this achievement possible."

"Existing therapies for iPD address symptoms but do not replace neurons lost to the disease," said Howard Federoff, M.D., Ph.D., Scientific Co-Founder, Chief Medical Officer, and EVP of Corporate Medicine and Science. "RNDP-001 represents a different investigational approach intended to restore dopaminergic neurons and neural circuitry. REPLACE will provide early clinical data to evaluate that potential."

RNDP-001 has received 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 REPLACE trial was supported in part by funding from the California Institute for Regenerative Medicine (CIRM), a state of California Agency that funds regenerative medicine, stem cell, and gene therapy research. (Grant Numbers CLIN1-14300; CLIN2-19068).

RNDP-001 is an investigational cell therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated.

About FDA Fast Track Designation

The FDA's Fast Track program is designed to facilitate the development and expedite the review of therapies that treat serious or life-threatening conditions and have the potential to address unmet medical needs. Programs granted Fast Track designation benefit from more frequent interactions with the FDA, eligibility for Accelerated Approval and Priority Review, and the option to submit a New Drug Application on a rolling basis.

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 induced pluripotent stem cell (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)

The California Institute for Regenerative Medicine (CIRM) is a state agency created by California voters to accelerate stem cell and gene therapies for people with unmet medical needs. Since 2004, Californians have entrusted CIRM with $8.5 billion to accelerate promising discoveries through clinical trials, train a regenerative medicine workforce, strengthen the state's biotechnology economy, and expand access to transformative treatments. Today, CIRM is pioneering new models of therapy development and accelerating medical breakthroughs that change lives — in California and around the world. For more information, visit www.cirm.ca.gov.

SOURCE Kenai Therapeutics/BIOCOM