Strategic Update and New Path to Value Creation
Palm Beach Gardens, FL, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Curative Biotechnology Inc. (OTC: CUBT) ("Curative Biotech" or the "Company"), a development-stage biomedical company focused on novel treatments for degenerative eye diseases, today announced the following update to shareholders.
Dear fellow shareholders and interested investors,
We are writing to provide an important update on our business strategy and operational path forward. The Company has been actively pursuing the most efficient and value-accretive route to advance our primary clinical program, the metformin-based eye drops licensed from the National Eye Institute. We are pleased to announce significant changes that we believe will substantially accelerate and de-risk our development path and place us on a sounder financial footing.
These changes include the establishment of a strategic partnership with a key industry player, a revised capital structure, and the official termination of our previous public offering plan.
Key Strategic Developments
1. Strategic Sublicense and Manufacturing Partnership
The Company has decided to seek a manufacturing and/or full product development sublicense agreement for its metformin-based eye drops. We believe this type of relationship will:
- Significantly de-risk the operational execution of our trial(s) and ensure a clear, reliable supply chain;
- Provide additional non-dilutive funding via upfront and clinical milestone payments;
- Accelerate the pathway for future commercialization for intermediate Dry AMD and other degenerative eye diseases.
The Company is in active negotiations with potential partners and believes this process could be completed prior to year end. Of course, there can be no assurance that any of these negotiations will result in a definitive agreement or that any transaction will close.
In addition to pursuing degenerative eye diseases in humans, the Company will focus on similar diseases in canines (K9). Two indications in particular are:
- Progressive Retinal Atrophy (PRA), with an estimated prevalence in the U.S. of just under six million dogs;
- Central Progressive Retinal Atrophy (CPRA), with an estimated prevalence in the U.S. of under 80,000 diagnoses per year.
CPRA is a K9 disease that closely mimics human Dry AMD and is eligible for the Minor Uses in Major Species accelerated approval pathway, usually requiring a smaller, single 24-dog trial relying heavily on preclinical work to establish reasonable expectation of effectiveness for conditional marketing approval from the FDA Center for Veterinary Medicine (CVM).
We intend to pursue CPRA as the first K9 indication, simultaneously with human Dry AMD, and believe the preclinical data already created for our human trial will provide the evidence of effectiveness required by the CVM. PRA will follow with a single effectiveness trial of roughly 300 dogs.
The veterinary ophthalmic drug market is estimated between $1.5 billion and $2.0 billion annually. Both CPRA and PRA represent unmet medical needs. There is no assurance that the CVM will accept our Dry AMD preclinical research as establishing reasonable expectation of efficacy.
2. Withdrawal of S-1 Registration Statement and Change to Reverse Stock Split Ratio
To better align our capital structure with the Company's updated strategic direction, the Board has taken two key actions:
- Withdrawal of S-1: The Company will formally file to withdraw the previously planned S-1 public offering.
- Revised Reverse Stock Split: The Board has approved a revised 150-to-1 reverse split, replacing the prior 400-to-1 requirement.
The reverse split remains subject to FINRA approval, which historically may take weeks to months. There is no assurance of approval or of any impact on the Company's capital needs.
Path to OTCQB Uplisting
Following execution of the strategic sublicense/manufacturing agreement and completion of the smaller reverse split, the Company intends to submit an application to uplist to the OTCQB Venture Market.
- Increased visibility and accessibility to investors, including institutions;
- Enhanced transparency and potential improvement in share liquidity;
- Positioning for a future uplisting to a national exchange when appropriate.
There is no assurance that the application to uplist will be accepted or that the Company will achieve these objectives.
Conclusion
Our new direction reflects management's and the Board's commitment to establishing a more sustainable, de-risked, and strategically aligned future. We believe these actions position Curative Biotech for meaningful advancement of our clinical program and long-term value creation.
Sincerely,
The Management of Curative Biotechnology
Future Curative Biotechnology Press Releases and Updates
Interested shareholders and investors may request notifications by emailing ir@curativebiotech.com
About Curative Biotechnology, Inc.
Curative Biotechnology, Inc. is a development-stage biomedical company focused on novel therapies for rare diseases. The Company is identifying, acquiring, and developing disease-modifying therapeutic drug candidates with an emphasis on rare disease indications. Curative Biotech currently has programs in degenerative eye disease, infectious disease, and neuro-oncology.
The Company's primary focus is its degenerative eye disease platform, supported by a worldwide exclusive license from the National Eye Institute (NEI) at the National Institutes of Health (NIH). Its first therapeutic candidate is a metformin-based reformulation intended for the treatment of intermediate and late-stage Age-Related Macular Degeneration (AMD). A first-in-human clinical trial is targeted for 2026 under a Cooperative Research and Development Agreement (CRADA) with the NEI.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially. These risks include, but are not limited to, the Company's ability to obtain regulatory approvals, secure sufficient funding, generate market acceptance, and manage operational challenges.
Readers are encouraged to review the Company's disclosures filed with OTC Markets for a detailed discussion of risk factors. The Company undertakes no obligation to update any forward-looking statements except as required by law.
Contact:
Paul Michaels, Executive Chairman
Office: 917-492-8855 Direct
or
Investor Relations
Curative Biotech (CUBT)
ir@curativebiotech.com
