Development-Stage Biotech Firm Abandons Public Offering, Pivots Focus to Animal Health Market While Pursuing Human Dry AMD Treatments
Palm Beach Gardens, FL – Curative Biotechnology Inc. (OTC: CUBT), a clinical-stage biomedical company developing novel therapeutics for degenerative eye conditions, unveiled a comprehensive strategic restructuring today. The company intends to pursue a dual-pathway approach combining human pharmaceutical development with veterinary ophthalmology, while simultaneously withdrawing its prior public offering registration and implementing operational cost controls.
Sublicensing Deal Expected to Provide Non-Dilutive Capital
At the core of Curative Biotechnology’s revised strategy sits a pending sublicense and manufacturing partnership for its metformin-based eye drop formulation. The company, which holds exclusive global rights to the technology from the National Eye Institute, is actively negotiating with industry partners to transfer manufacturing responsibilities and operational risk.
The arrangement is designed to accomplish three primary objectives: reduce execution risk inherent in clinical trial management, establish a predictable supply chain, and generate upfront payments plus clinical milestone funding that does not dilute existing shareholders. Company leadership indicates negotiations could conclude before year-end, though no definitive agreements currently exist.
Canine Market Emerges as Accelerated Approval Pathway
A novel element of the revised strategy targets the veterinary pharmaceutical sector. Curative Biotechnology intends to simultaneously advance two canine indications while pursuing the human Dry AMD indication, particularly focusing on Central Progressive Retinal Atrophy (CPRA) in dogs—a condition estimated to affect fewer than 80,000 dogs annually in the United States.
CPRA qualifies for the FDA’s Minor Uses in Major Species regulatory pathway, which historically permits conditional marketing approval based on smaller trials (approximately 24 dogs) supplemented by preclinical data. The company plans to leverage existing preclinical research from its human development program to satisfy FDA Center for Veterinary Medicine requirements. A second indication, Progressive Retinal Atrophy (PRA), affecting approximately 6 million U.S. dogs, would follow with a larger effectiveness trial.
The veterinary eye care pharmaceutical market represents a $1.5 billion to $2.0 billion annual opportunity, providing a potential revenue stream before human pharmaceutical approvals materialize.
Capital Structure Refinement and Listing Pathway
To align its financial framework with the updated development plan, Curative Biotechnology’s Board approved two structural modifications. First, the company will formally withdraw the previously planned S-1 public offering registration. Second, the Board has amended the reverse stock split ratio from 400-to-1 to 150-to-1, pending FINRA approval.
Upon completion of the sublicense transaction and reverse split approval, company management intends to submit an application for OTCQB Venture Market uplisting. This listing tier would enhance institutional investor visibility, improve market transparency, and provide a foundation for future national exchange consideration.
Timeline and Development Expectations
The company targets initiation of first-in-human clinical trials for its metformin-based formulation in 2026, operating under a Cooperative Research and Development Agreement with the National Eye Institute. The veterinary pathway is expected to advance more rapidly given the abbreviated approval requirements and smaller trial populations.
Management emphasized that no assurance exists regarding partner agreement completion, CVM acceptance of preclinical data, FINRA approval of the reverse split, OTCQB uplisting acceptance, or the ultimate commercial viability of any indication. The company maintains a pipeline that also includes infectious disease and neuro-oncology programs, though degenerative eye disease represents the primary focus.
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Curative Biotechnology Charts New Strategic Course with Veterinary-First Development Model
Development-Stage Biotech Firm Abandons Public Offering, Pivots Focus to Animal Health Market While Pursuing Human Dry AMD Treatments
Palm Beach Gardens, FL – Curative Biotechnology Inc. (OTC: CUBT), a clinical-stage biomedical company developing novel therapeutics for degenerative eye conditions, unveiled a comprehensive strategic restructuring today. The company intends to pursue a dual-pathway approach combining human pharmaceutical development with veterinary ophthalmology, while simultaneously withdrawing its prior public offering registration and implementing operational cost controls.
Sublicensing Deal Expected to Provide Non-Dilutive Capital
At the core of Curative Biotechnology’s revised strategy sits a pending sublicense and manufacturing partnership for its metformin-based eye drop formulation. The company, which holds exclusive global rights to the technology from the National Eye Institute, is actively negotiating with industry partners to transfer manufacturing responsibilities and operational risk.
The arrangement is designed to accomplish three primary objectives: reduce execution risk inherent in clinical trial management, establish a predictable supply chain, and generate upfront payments plus clinical milestone funding that does not dilute existing shareholders. Company leadership indicates negotiations could conclude before year-end, though no definitive agreements currently exist.
Canine Market Emerges as Accelerated Approval Pathway
A novel element of the revised strategy targets the veterinary pharmaceutical sector. Curative Biotechnology intends to simultaneously advance two canine indications while pursuing the human Dry AMD indication, particularly focusing on Central Progressive Retinal Atrophy (CPRA) in dogs—a condition estimated to affect fewer than 80,000 dogs annually in the United States.
CPRA qualifies for the FDA’s Minor Uses in Major Species regulatory pathway, which historically permits conditional marketing approval based on smaller trials (approximately 24 dogs) supplemented by preclinical data. The company plans to leverage existing preclinical research from its human development program to satisfy FDA Center for Veterinary Medicine requirements. A second indication, Progressive Retinal Atrophy (PRA), affecting approximately 6 million U.S. dogs, would follow with a larger effectiveness trial.
The veterinary eye care pharmaceutical market represents a $1.5 billion to $2.0 billion annual opportunity, providing a potential revenue stream before human pharmaceutical approvals materialize.
Capital Structure Refinement and Listing Pathway
To align its financial framework with the updated development plan, Curative Biotechnology’s Board approved two structural modifications. First, the company will formally withdraw the previously planned S-1 public offering registration. Second, the Board has amended the reverse stock split ratio from 400-to-1 to 150-to-1, pending FINRA approval.
Upon completion of the sublicense transaction and reverse split approval, company management intends to submit an application for OTCQB Venture Market uplisting. This listing tier would enhance institutional investor visibility, improve market transparency, and provide a foundation for future national exchange consideration.
Timeline and Development Expectations
The company targets initiation of first-in-human clinical trials for its metformin-based formulation in 2026, operating under a Cooperative Research and Development Agreement with the National Eye Institute. The veterinary pathway is expected to advance more rapidly given the abbreviated approval requirements and smaller trial populations.
Management emphasized that no assurance exists regarding partner agreement completion, CVM acceptance of preclinical data, FINRA approval of the reverse split, OTCQB uplisting acceptance, or the ultimate commercial viability of any indication. The company maintains a pipeline that also includes infectious disease and neuro-oncology programs, though degenerative eye disease represents the primary focus.