Burzynski Research Institute Reports $1.39 Million Net Loss for Fiscal Year Ending February 2025

Burzynski Research Institute, Inc. (BRI) reported a net loss of approximately $1.39 million for the fiscal year ending February 28, 2025, compared to a loss of $1.34 million in the previous year. The increase in net loss was primarily attributed to a 21% rise in research and development costs, which totaled about $1.05 million, driven by higher personnel and facility expenses. In contrast, general and administrative expenses decreased by 28% to approximately $340,000, largely due to reduced legal and professional fees. The company has not generated significant operating revenue since its inception and does not expect to do so until its product, Antineoplastons, receives FDA approval.

The company continues to rely on funding from Dr. Stanislaw Burzynski, who has supported BRI through his medical practice. This funding arrangement is formalized in a Research Funding Agreement, which has been extended until February 28, 2026. BRI's operations are currently on hold due to a full clinical hold imposed by the FDA on its investigational new drug application (IND 43742), which has limited the company's ability to enroll new patients in clinical trials. The company is also preparing for a Phase III clinical trial of Antineoplastons, pending the resolution of the clinical hold and availability of funds.

In terms of operational metrics, BRI has conducted multiple Phase II clinical trials for Antineoplastons, focusing on various cancers, including brain tumors. The company has received orphan drug designation from the FDA for its Antineoplastons, which may provide certain market exclusivity benefits if approved. However, the company has faced challenges in its clinical trials, including a history of clinical holds and the need for additional studies to satisfy FDA requirements. As of now, BRI has no full-time employees and operates with a minimal staff structure.

Looking ahead, BRI estimates it will require approximately $1.2 million for the fiscal year ending February 28, 2026, with 95% of this budget allocated to research and development. The company acknowledges the uncertainty surrounding its future funding, as it is entirely dependent on Dr. Burzynski's continued financial support. If this funding were to cease, BRI would need to seek alternative financing, which may not be readily available. The company has indicated that it may pursue additional capital through equity or debt financing, but there are no assurances that it will be able to secure such funding on favorable terms.

Overall, Burzynski Research Institute remains in a precarious financial position, with ongoing losses and reliance on a single source of funding. The future of its clinical programs and potential market entry for Antineoplastons hinges on regulatory approvals and the ability to secure necessary financial resources.