• Financing led by Hatteras Venture Partners, with participation from foundational investors Lumira Ventures and adMare BioInnovations and a new syndicate of life sciences investors
   
• Proceeds will be used to advance lead Dualase® therapeutic candidate through initial clinical biomarker proof-of-concept in patients with C9ORF72-associated ALS
  
  
• Gene-editing platform designed to precisely remove disease-causing DNA repeat expansions, with potential applications across more than 40 repeat expansion disorders

TORONTO, Nov. 2, 2026 /CNW/ -- Specific Biologics, a biotechnology company pioneering a new generation of precision gene-editing therapies for serious genetic diseases, today announced the closing of an oversubscribed US$35 million Series A financing. The round was led by Hatteras Venture Partners, with participation from foundational investors Lumira Ventures and adMare BioInnovations, alongside new investors Genesys Capital, Business Development Bank of Canada's (BDC) Life Sciences Venture Fund, DeepWork Capital and Seido Capital. 

The financing will support development of Specific Biologics' lead Dualase® therapeutic candidate through initial clinical biomarker proof-of-concept in the first cohort of an adaptive Phase I/II clinical trial in patients with C9ORF72-associated amyotrophic lateral sclerosis (ALS), a neurodegenerative disease for which there are currently no approved therapies.

"This financing represents a defining step toward our goal of bringing a potentially transformative medicine to people living with ALS," said Brent Stead, Chief Executive Officer of Specific Biologics. "Our goal is to address the disease at its genetic source to create a new therapeutic option for patients who have waited far too long."

"Gene editing has the potential to transform the treatment of genetic diseases, but realizing that promise requires overcoming longstanding challenges in precision, specificity and delivery," said Ben Scruggs, Partner at Hatteras Venture Partners. "Specific Biologics has developed a highly differentiated technology with significant therapeutic and commercial potential designed to address these challenges, supported by compelling preclinical evidence."

"Our decision to invest meaningful additional capital in Specific reflects our growing conviction in the scientific differentiation, clinical potential and long-term value of the Dualase® platform," said Nikhil Thatte, Partner at Lumira Ventures. "We believe the opportunity to generate early clinical proof-of-concept in ALS patients represents an important inflection point for the company and a meaningful step toward realizing the broader promise of its technology."

Specific Biologics' proprietary Dualase® platform is designed to overcome important limitations of conventional gene-editing technologies by precisely removing disease-causing DNA repeat expansions while preserving the normal sequences required for biological function. These abnormal stretches of repetitive DNA are implicated in more than 40 genetic disorders. Specific has demonstrated editing in preclinical studies in multiple neuromuscular repeat expansions.

"Specific Biologics has assembled a dynamic and experienced team in the field of genome editing and an excellent syndicate of investors with the strategic vision to translate breakthrough science into clinical proof of concept," said Paul Hastings, Board Chair of Specific Biologics. "Their technology has the potential to redefine what is possible in gene editing and open the door to therapeutic approaches for devastating genetic conditions that have historically been beyond reach."

About ALS and Dualase®

ALS is a progressive and ultimately fatal neurodegenerative disease characterized by the loss of motor neurons responsible for voluntary muscle movement, including speaking, swallowing and breathing. An expansion of repeated DNA sequences in the C9ORF72 gene is the most common known inherited genetic cause of ALS and is also associated with frontotemporal dementia.

Specific Biologics' lead Dualase® candidate is designed to precisely shorten the pathogenic C9ORF72 repeat expansion at the DNA level without off-target effects, offering the potential for durable therapeutic benefit by addressing the underlying genetic driver of disease rather than solely its downstream effects. Unlike larger gene editing systems, its compact size fits within a single adeno-associated virus (AAV) to be delivered directly to the central nervous system to reach affected motor neurons.

In preclinical dose-response studies using patient-derived ALS cell models, Dualase® achieved nearly complete collapse of the pathogenic C9ORF72 repeat expansion. Dualase® also collapses repeat-expanded C9ORF72 in disease-relevant animal models with correction of downstream hallmarks of the disease and no detectable off-target effects.

About Specific Biologics

Specific Biologics is a venture-backed biotechnology company pioneering next-generation precision gene-editing therapies for serious genetic diseases. Its proprietary two-site Dualase® platform is designed to overcome key limitations of existing gene-editing technologies through efficient, precise and highly specific in vivo editing of challenging genetic targets. The versatile Dualase® platform supports both targeted DNA removal and repair using single AAV delivery or lipid nanoparticle-delivered mRNA, creating opportunities across multiple therapeutic areas to unlock new treatment possibilities for patients with devastating genetic disorders.

For more information, visit www.specificbiologics.com or follow Specific Biologics Inc. on LinkedIn at www.linkedin.com/company/specific-biologics

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SOURCE Specific Biologics Inc.