Collaboration supports pre-IND development activities and establishes a structured path for potential next-stage development and commercialization

KeifeRx, a privately held biotechnology company developing disease-modifying therapies for neurodegenerative disorders, today announced that it has entered into a research collaboration and option agreement with Amneal Pharmaceuticals to support the pre-IND development of KFRX06, KeifeRx's preclinical candidate designed to inhibit leucine-rich repeat kinase 2 (LRRK2), a gene strongly implicated in Parkinson's disease biology.

Under the agreement, KeifeRx will conduct a research program intended to generate key pre-IND outputs to support Amneal's evaluation of KFRX06 and inform potential next-stage development. Financial terms of the agreement were not disclosed.

"Amneal's expanding Parkinson's disease franchise and demonstrated ability to execute across development, manufacturing, and commercialization make them an ideal partner as we advance KFRX06," said Chris Hoyt, Chief Executive Officer of KeifeRx.

"We are excited to work together to progress our potent LRRK2 inhibitor through pre-IND development and support the potential future development of differentiated therapeutic approaches for people living with Parkinson's disease."

About KFRX06

KFRX06 is a brain-penetrant preclinical candidate designed to inhibit LRRK2 and explore modulation of multiple disease-relevant biological pathways implicated in Parkinson's disease.

In non-clinical studies, KFRX06 demonstrated favorable plasma-to-brain exposure and was designed to minimize peripheral exposure associated with other LRRK2 inhibitor approaches. In preclinical models, KFRX06 has shown evidence of LRRK2 inhibition target engagement and effects on biomarkers associated with protein aggregation, inflammation, and neuronal health.

KeifeRx's program rationale is that LRRK2 inhibition alone may be insufficient to address the breadth of Parkinson's pathology. Accordingly, KFRX06 was designed as a comprehensive and synergistic approach that targets validated kinase receptors to harmoniously alleviate inflammation, block tau hyperphosphorylation, and promote autophagy, while inhibiting LRRK2 activity and protecting dopamine neurons.

About KeifeRx

KeifeRx is a privately held biopharmaceutical company developing a differentiated pipeline of oral, brain-penetrant kinase inhibitors designed to restore autophagy and reduce neuroinflammation in neurodegenerative diseases. The company's lead candidate, KFRX03, is in development for treatment of dementia, with additional programs exploring applications across Alzheimer's disease, Parkinson's disease, and other CNS disorders.

Georgetown University owns several issued patents and pending patent applications on the underlying technology related to the use of kinase inhibitors for the treatment of neurodegenerative diseases with KeifeRx cofounder Charbel Moussa, MBBS, Ph.D., named as one of three inventors. KeifeRx has an exclusive license to intellectual property from Georgetown University. For more information on KeifeRx, please visit https://www.keiferx.com.

About Amneal

Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX), headquartered in Bridgewater, New Jersey, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding research and development plans, timelines, and potential outcomes for KFRX06. Actual results may differ materially due to risks and uncertainties inherent in drug research and development, manufacturing, regulatory interactions, and other factors. There can be no assurance that the collaboration will result in any future transaction or that KFRX06 will successfully progress to IND submission or clinical development.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260109422883/en/

Media Contacts

Chris Hoyt

CEO, KeifeRx, Inc.

c.hoyt@keiferx.com

KeifeRx Announces Research Collaboration and Option Agreement with Amneal Pharmaceuticals to Advance KFRX06, a Brain-Penetrant LRRK2 Program for Parkinson's Disease