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Company milestones:
Regen BioPharma, Inc. milestones update regarding the Company’s recent submission of an Orphan Drug Application to the FDA for HemaXellerate as well as the Company’s planned Phase 1 clinical trial of HemaXellerate. HemaXellerate is the Company’s innovative stem cell-derived therapy which has already received FDA Investigational New Drug Application (IND) clearance.
ORPHAN DRUG APPLICATION:
On October 19, 2025, the Company received an acknowledgement letter from the FDA indicating preliminary comments have been addressed and informing the Company that the application will undergo FDA review which customarily takes 90 days. It cannot be determined whether or not the recent government shutdown will result in the review taking longer than 90 days.
HEMAXELLERATE PHASE 1 CLINICAL TRIAL AND GOVERNMENT FUNDING APPLICATION:
The Company has identified a government grant intended to fund Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases. The grant provides up to $900,000 per year for a maximum of 4 years to fund clinical trials. The Company is in the process of finalizing the budget for its planned Phase 1 clinical trial of HemaXellerate and will be applying for this grant upon finalization. The Company believes its application will be ready for submission late January2026.
David Koos, the Company’s ’Chairman and CEO, expressed confidence that both Orphan Drug status for HemaXellerate and government funding for HemaXellarate’s Phase 1 Clinical trial can be obtained.
“The incentives gained by being granted Orphan Drug designation for HemaXellerate would be substantial. These incentives include a tax credit equal to 25% of qualified clinical testing expenses (QCTEs) as well as up to seven years of marketing exclusivity. As far as the grant opportunity is concerned, I’ve never seen a grant more suited for a product like HemaXellerate or a product more suited for a grant. I’m confident and excited regarding these developments.”
Koos went on to say that although initiation of the planned Phase 1 Clinical Trial is not exclusively contingent upon the receipt of government funding the receipt of such funding would enable the Company to apply additional internal resources toward advancing other products in development towards commercialization.