EXOUSIA AI SECURES HIGH-VALUE ORPHAN DRUG DESIGNATION
ORLANDO, Fla., Dec. 02, 2025 (GLOBE NEWSWIRE) -- LAMY, to become Exousia Bio, Inc. (OTCPINK: LMMY) (the "Company" or "Exo Bio"), operating as a leading U.S. biotechnology company focused on exosome-based cancer therapy, today announced the completion of the acquisition of 100% of Exousia AI, Inc. in an all-stock transaction. LAMY issued 62,223,000 restricted shares of its Common stock to finalize the deal, consolidating ownership of a highly promising preclinical oncology platform.
Foundation Built on Exclusive, Worldwide Licensing
The strategic acquisition reinforces Exousia Bio's position as an innovator in the exosome space. The Company has secured two exclusive worldwide licenses for Exosome technology. These patented and patent-pending intellectual property rights are foundational, covering the critical areas of exosome use in cancer therapy and the proprietary loading of exosomes for targeted drug delivery. The versatility of the loading process, applicable to both human-derived and plant-based exosomes, establishes a robust and scalable platform for future drug development.
Orphan Drug Designation (ODD): A Transformative Preclinical Achievement
A cornerstone of this acquisition is the immediate benefit of the recently received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its Glioblastoma (GBM) therapy.
Achieving ODD at this preclinical stage is a highly significant corporate and regulatory milestone. This designation not only acknowledges the therapy's potential to address a rare disease with profound unmet medical needs but also confers substantial, immediate, and long-term financial and strategic advantages.
The ODD's significant value proposition includes:
- 7 Years of Market Exclusivity: Post-approval, the designation provides a guaranteed seven years of market exclusivity, securing a competitive advantage and protecting future revenue streams.
- Tax and Fee Benefits: The Company will benefit from significant tax credits for qualified clinical research costs and a waiver of the New Drug Application (NDA) user fees.
- Expedited Regulatory Pathway: ODD status facilitates close consultation with the FDA, offering assistance with study design and providing a clearer, potentially accelerated path toward regulatory approval.
While the Company plans to retain a specialized firm to conduct an independent valuation of the ODD, initial estimates place its potential value in the tens of millions of dollars, underscoring the foresight of the acquisition strategy.
Preclinical Success and Corporate Expansion
The transaction includes a completed in-vivo mouse study demonstrating extremely positive results using Exosomes to treat Glioblastoma multiforme (GBM). The findings from this study are currently being compiled into a comprehensive research paper for peer-reviewed publication.
To support the rapid progression of this pipeline, LAMY will expand its executive leadership and Board of Directors, with plans to announce a Chief Science Officer and Chief Medical Officer, and form a Scientific Advisory Board in the near future.
About LAMY (to become) Exousia Bio, Inc.
Exousia Bio, Inc., a leader in exosome-based biotechnology, develops and manufactures mammalian and plant-derived exosomes using proprietary technologies for nucleic acid loading and targeted delivery to tissues and cells. The platform enables the custom production of exosomes with enhanced genetic functionality, capable of selectively targeting specific cells to address diseases with significant unmet medical needs. These engineered exosomes have demonstrated the potential to target cancer stem cells, the primary drivers of recurrence and metastasis in various cancers, including glioblastoma and pancreatic cancer. The same platform technology also holds promise for treating a broad spectrum of viral infections.
SAFE HARBOR
Forward-looking statements in this release are made under the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. LAMY's forward-looking statements do not guarantee future performance. This news release includes forward-looking statements concerning the parties' future level of business. These statements are necessarily subject to risk and uncertainty. Actual results could differ materially from those projected in these forward-looking statements due to certain risk factors that could cause results to differ materially from estimated results. Management cautions that all statements as to future results of operations are necessarily subject to risks, uncertainties, and events that may be beyond the control of LAMY, and no assurance can be given that such results will be achieved. Potential risks and uncertainties include, but are not limited to, the ability to procure, appropriately price, retain, and complete projects, as well as changes in products and competition.
CONTACT:
Exousia Bio, Inc.
www.exousiabio.com
X: @ExousiaBio
Investor Relations
ir@exousiabio.com
