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Axial Therapeutics Raises $37.25 Million in Series C Financing to Advance its Pipeline of Gut-Targeted Small Molecule Drugs for Neurological Diseases and Disorders

- Proceeds will support Axial's randomized, controlled Phase 2b clinical trial for lead candidate, AB-2004, a molecular therapeutic to treat irritability in children with autism

- Funding positions company for platform and pipeline growth

- Completion of new round brings total investment in company to $91.5 million to date

WOBURN, Mass., October 13, 2021-- Axial Therapeutics, a clinical-stage biopharmaceutical company dedicated to improving the lives of people with neurological diseases, today announced the completion of a $37.25 million Series C financing. OneVentures, a venture capital firm headquartered in Sydney, Australia, and the University of Tokyo Innovation Platform Company (UTokyo IPC) led the round as new investors, joined by Autism Impact Fund and Corundum Systems Biology (Tokyo, Japan). Existing investors, Longwood Fund, Seventure Partners, Taiho Ventures, and Domain Associates also participated in this round. The additional financing builds upon Axial’s earlier Series A and Series B financing rounds, bringing total investment in the company to $91.5 million to date.

Proceeds from the Series C financing will be used to advance the clinical development of Axial’s lead candidate, AB-2004, a gut-restricted molecular therapy for irritability in children with autism. In addition, the funds will be used to drive forward the company’s drug discovery programs based on the company’s platform in the microbiome gut-brain axis. Axial is advancing a pipeline of small molecule drugs with defined mechanisms of action that act on new targets to mitigate the impact of metabolites and bacteria in the gut linked to neurological disease pathology, progression, and symptoms. The company’s drug discovery approach is rooted in the groundbreaking research of its co-founder and chief scientist, Dr. Sarkis Mazmanian at the California Institute of Technology, who has elucidated clear biological links implicating the gut microbiome, via the gut-brain axis, in serious neurological conditions.

“Axial is focused on fundamentally changing the way we approach neurological diseases by harnessing our specialized expertise on the biological role of the microbiome gut-brain axis and its influence on the central nervous system,” said A. Stewart Campbell, Ph.D., Chief Executive Officer of Axial Therapeutics. “We are grateful for the support and confidence demonstrated by both our existing and new investors in our novel microbiome approach. This significant capital raise enables us to advance AB-2004, which is poised to redefine the treatment of irritability in autism, and fulfill the potential of our robust drug discovery platform to identify new therapeutic targets in the gut and develop new medical interventions that make a meaningful difference in the lives of patients.”

Board of Directors Additions and Changes

In connection with the financing, Sarah Meibusch, principal, OneVentures, and Makoto (Mark) Ohori, Ph.D., UTokyo IPC have joined Axial’s board of directors.

“The gut microbiome and its link to the pathology and symptoms associated with neurodegenerative diseases is an exciting area of medicine that has great potential and deserves recognition,” said Ms. Meibusch. “With proven scientific expertise in the gut-brain axis and a robust small molecule drug discovery program, Axial is poised to address unmet medical needs for serious neurological disorders, including autism and Parkinson’s disease.”

“Axial has emerged as the scientific leader in microbiome gut-brain axis and its role in the central nervous system,” said Dr. Ohori. “We are excited to support the company as it works to fulfill the promise of AB-2004 for irritability in children with autism, and pursues new clinical development programs that leverage its expertise in the gut microbiome to bring forward gut-restricted therapies for a broad range of neurodegenerative diseases and neurodevelopmental disorders.”

In addition, the company announced the appointment of Nora Frey from Seventure to its Board of Directors. Mrs. Frey is filling a vacant board seat previously held by a Seventure representative.

“On behalf of the Board of Directors, we are grateful to receive the tremendous support from this diverse group of global investors who share in Axial’s ambitious vision,” said Ronald C. Renaud, Axial’s Board chair. “I am also pleased to welcome Sarah, Mark and Nora as new members of our Board. Their expertise will be invaluable as we continue to leverage our scientific leadership in the gut-brain axis to transform the lives of patients.”

About AB-2004

Axial’s lead product candidate is AB-2004, a first-in-class, molecular therapeutic that targets the microbiome gut-brain axis and its role in autism. AB-2004 has a unique mechanism of action that selectivity sequesters certain bacterially derived metabolites in the gut before they enter the bloodstream and reach the brain. Axial’s gut-targeted approach minimizes the potential for side effects due to a lack of systemic exposure to the drug. In a Phase 1b/2a clinical trial, AB-2004 was safe and well-tolerated, exhibiting no drug-related serious adverse events, consistent with a large body of existing human safety data. AB-2004 was also shown to reduce several microbial metabolites implicated in autism and showed evidence of improving key behaviors including irritability and anxiety.

About Axial Therapeutics

Axial Therapeutics is a clinical-stage biopharmaceutical company dedicated to improving the lives of people with neurological diseases. The company is the scientific leader in the biological role of the microbiome gut-brain axis and its influence on the central nervous system. Harnessing its unique expertise in the microbiome, Axial is developing small molecule drugs with defined mechanisms of action that act on new targets to mitigate the impact of metabolites and bacteria in the gut linked to neurological disease pathology, progression, and symptoms. The company is advancing a pipeline of microbiome-inspired therapeutics for diseases with significant unmet patient need, including autism and Parkinson’s disease, and is also pursuing pre-clinical discovery of gut-targeted therapies in oncology. Axial’s lead product candidate is AB-2004, a molecular therapeutic in Phase 2 clinical trials for the treatment of irritability in children with autism. For more information, visit https://axialtx.com.

Contact:
Investor:
Jeffrey Young, CFO
781-701-8467
jeffrey@axialtx.com

Media:
Mike Beyer
Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com
312-961-2502


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