Spinogenix Honored By BioTech Breakthrough With “Regenerative Therapeutics Company of the Year”

LOS ANGELES, November 5, 2026 - Spinogenix, Inc., a clinical-stage biopharmaceutical company developing first-in-class synaptic regenerative and corrective therapeutics, today announced it has been awarded "Regenerative Therapeutics Company of the Year" in the sixth annual BioTech Breakthrough Awards program conducted by BioTech Breakthrough, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products and services around the globe.

Spinogenix is pioneering first-in-class, investigational therapeutics that have the potential to serve as restorative medicine for some of the most devastating neurological conditions, helping restore brain synapses to improve the lives of patients worldwide. This is done by developing small-molecule oral therapeutics that can penetrate the blood-brain barrier to actively regenerate lost synapses or correct synaptic dysfunction in the brain. Spinogenix's lead candidate, tazbentetol (SPG302), is a first-in-class Transient Activator of Glutamatergic Synaptogenesis (TAGS). Its second clinical program, codabakalner (SPG601), is a first-in-class synaptic corrective therapy targeting BK channels for Fragile X syndrome (FXS) and autism. Spinogenix has also shown cross-indication activity throughout its pipeline, demonstrating that active synaptic regeneration and correction can lead to tangible functional recovery:

In Alzheimer's Disease, a Phase 2a trial showed tazbentetol producing rapid cognitive improvements within four weeks that also lasted through a 24-week open-label extension. Long-term data have shown continued cognitive benefits, and patients experienced real-world improvements, such as regaining the ability to read. In a Phase 2a trial, 82% of Amyotrophic Lateral Sclerosis (ALS) patients have shown a stable or improved rate of decline, with improvements in brain activity biomarkers. An FDA-authorized Expanded Access Program has been launched for patients ineligible for trials, which the FDA has since authorized to expand to 400 patients.

In addition, a Phase 2 trial for Schizophrenia patients has shown that tazbentetol can achieve greater PANSS symptom reductions over placebo. A "triple-action" mechanism targets glutamatergic synapse loss and addresses positive, negative, and cognitive symptoms simultaneously. Spinogenix has also applied its candidate to Ophthalmology, publishing preclinical evidence demonstrating that tazbentetol preserves retinal ganglion cells and synaptic connectivity, protects the optic nerve, and reverses decreases in Pattern Electroretinogram amplitude in both glaucoma and diabetic retinopathy mouse models. Tazbentetol may offer a new approach to preserving or restoring visual function.

Codabakalner, a novel, oral investigational small molecule, is the first positive modulator of BK channels to be clinically evaluated in patients with FXS, the leading inherited cause of intellectual disability and a leading known genetic cause of autism. In a Phase 2a study published in Scientific Reports, codabakalner reduced elevated gamma-band EEG power in adult men with FXS, alongside improvements in executive function and selective attention. Codabakalner is now being evaluated in CLARITY (NCT07439510), an adaptive Phase 2b/3 basket trial in FXS supported by grant funding from the FRAXA Research Foundation. In October 2026, Spinogenix expanded CLARITY to include its first study in idiopathic autism spectrum disorder, a Phase 2b study that uses EEG screening to enroll participants who share the elevated gamma-band signature seen in Fragile X. Codabakalner has received FDA Orphan Drug and Fast Track designations and EMA orphan designation for FXS.

"For decades, neurological drug development has achieved only slowing disease decline. Our cross-indication clinical success shows progress towards changing the treatment paradigm from managed decline to structural recovery in neurological conditions, and the development of a novel regenerative therapy," said Dr. Stella Sarraf, CEO and Founder of Spinogenix. "It's a great honor to accept this recognition from BioTech Breakthrough. When I founded Spinogenix, restoring synaptic connections in the brain was a bold idea few believed was possible. Doing right by patients has been our moral compass from day one, and it drives every decision we make, from expanding access to tazbentetol for people living with ALS to using brain-wave screening to identify the people with autism most likely to benefit from codabakalner. This recognition belongs to the patients, families and clinicians who have trusted us with this work."

The life sciences and biotechnology sector is rapidly redefining how diseases are discovered, diagnosed and treated, transforming one of the world's most critical industries. From genomics and gene editing to AI-powered drug discovery, cell and gene therapies, and advanced bioprocessing, biotechnology is delivering faster breakthroughs, more personalized care and better outcomes for patients around the world.

The mission of the annual BioTech Breakthrough Awards program is to recognize the innovators transforming the global biotechnology and life sciences landscape with breakthrough technology. The program conducts a comprehensive analysis of the companies redefining how therapies are researched, developed, manufactured and delivered. From AI-driven drug discovery platforms and precision medicine to synthetic biology, bioinformatics, and next-generation diagnostics and biomanufacturing, these innovations are enabling life sciences organizations to accelerate research, reduce development costs, bring life-changing treatments to market faster, and shape the future of human health.

"Spinogenix represents a paradigm shift in regenerative therapeutics. Synapse loss is the unifying root cause behind motor, cognitive, and sensory decline across multiple devastating neurodegenerative and neuropsychiatric conditions. The regenerative field has historically focused on complex stem cell therapies, gene editing, and invasive tissue engineering rather than targeting actual neural circuit repair," said Bryan Vaughn, Managing Director, BioTech Breakthrough. "By restoring physical synaptic connectivity, rather than merely slowing disease progression or managing symptoms, Spinogenix is redefining the boundaries of restorative medicine for some of the most devastating neurological conditions. We're awarding them with 'Regenerative Therapeutics Company of the Year.'"

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About Spinogenix
Spinogenix, Inc. is a clinical-stage biopharmaceutical company developing first-in-class synaptic regenerative and corrective therapeutics for neurodegenerative, neuropsychiatric and neurodevelopmental diseases. Its pipeline includes codabakalner for Fragile X syndrome and autism, and tazbentetol for ALS, Alzheimer's disease and schizophrenia. Learn more at spinogenix.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements about the design, enrollment, timing and potential outcomes of Spinogenix's clinical trials, including the CLARITY trial; the potential of EEG-based enrichment; the Expanded Access Program for tazbentetol; and the therapeutic potential of tazbentetol and codabakalner. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Tazbentetol and codabakalner are investigational and have not been approved by any regulatory authority. Spinogenix undertakes no obligation to update these statements except as required by law.

About BioTech Breakthrough
Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the BioTech Breakthrough Awards program is devoted to honoring excellence in life science and biotechnology solutions, services and companies. The BioTech Breakthrough Awards provide public recognition for the achievements of biotechnology companies and products in categories including BioPharma, Genomics, Therapeutics, Immunology, Food Science and BioAgriculture, and more. For more information visit BioTechBreakthroughAwards.com

Tech Breakthrough LLC does not endorse any vendor, product or service depicted in our recognition programs, and does not advise technology users to select only those vendors with award designations. Tech Breakthrough LLC recognition consists of the opinions of the Tech Breakthrough LLC organization and should not be construed as statements of fact. Tech Breakthrough LLC disclaims all warranties, expressed or implied, with respect to this recognition program, including any warranties of merchantability or fitness for a particular purpose.

Investor Contact
Sasha Damouni Ellis
Head of Investor Relations, Spinogenix
[email protected]