Kala Bio Celebrates Trump Executive Order as Game-Changer for Psychedelic Medicine

KALA

Published on 04/21/2026 at 07:01 am EDT

ARLINGTON, Mass., April 21, 2026 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ: KALA) (“KALA” or the “Company”) today celebrated the landmark Executive Order signed by U.S. President Donald J. Trump on April 18, 2026. The Order directs the FDA to prioritize the review of psychedelic compounds, instructs the DEA to reduce research restrictions, establishes expanded patient access pathways under the Right to Try Act, and allocates $50 million in federal funding to accelerate psychedelic therapy research, representing the most sweeping shift in U.S. federal psychedelic policy in decades.

The Executive Order arrives at a pivotal moment, and KALA is uniquely and strategically positioned to capitalize on this seismic policy shift. KALA congratulates its client, Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTCQB: TRUFF) (“Red Light”), on this transformative federal policy shift. With expanded patient access pathways, reduced DEA research restrictions, and national priority review signals from the FDA, Red Light’s psychedelic drug development programs are now positioned to advance with materially stronger regulatory and commercial momentum and to deliver on the full clinical and therapeutic promise of its portfolio within a supportive federal framework. KALA is proud that Red Light’s development strategy is supported by KALA’s proprietary Researgency.ai agentic artificial intelligence platform, licensed worldwide from Younet AI.

As disclosed on March 18, 2026, Red Light engaged KALA’s Researgency.ai agentic AI platform, licensed worldwide from Younet AI, to support its clinical development strategy, including clinical planning, protocol optimization, and scenario modelling. Today’s policy announcement reinforces Researgency.ai's commercial relevance to the psychedelic drug development sector and underscores KALA’s position as the dedicated AI infrastructure partner for the broader biotechnology industry.

“President Trump’s Executive Order is the clearest signal yet that psychedelic medicine is moving from under-researched science to mainstream healthcare, and KALA is already embedded to capitalize on this revolution. We are thrilled to have Red Light Holland as one of our Researgency.ai clients, and today’s policy shift materially strengthens the outlook for their programs. As psychedelic medicine moves toward multi-session, dose-optimized protocols under a supportive federal framework, clinical development becomes materially more complex, with more variables, more patient subgroups, and more decision points. Researgency.ai delivers compounding value by providing secure, on-premises agentic AI applied to proprietary biological and clinical data. We congratulate Red Light on this transformative moment for the industry and look forward to expanding our role as the dedicated AI infrastructure partner for the psychedelic and broader biotech industries,” said Avi Minkowitz, Chief Executive Officer of KALA BIO.

About Researgency.ai

Researgency.ai is an agentic, on-premises AI platform developed by Kala Bio in collaboration with Younet. Designed for secure, scalable deployment in regulatory-compliant biopharmaceutical environments, Researgency.ai enables biotech companies to turn clinical and molecular data into actionable insights for therapeutic optimization, digital health integration, and commercialization.

ABOUT KALA BIO (NASDAQ: KALA)

KALA BIO, Inc. is a clinical-stage biopharmaceutical company building a dedicated, on-premises AI infrastructure platform for the biotechnology industry. The Company's dual strategy combines a proprietary biologics pipeline—including its mesenchymal stem cell secretome (MSC-S) platform and FDA Orphan Drug- and Fast Track-designated product candidates—with a scalable AI platform-as-a-service business designed to deploy secure, purpose-built AI solutions directly within biotech and pharmaceutical client environments.

Through its exclusive worldwide license for the Researgency AI research platform from Younet, Kala intends to serve as the dedicated AI infrastructure partner for the biotechnology industry, enabling organizations of all sizes to unlock the value of their proprietary biological data without surrendering control. Kala is advancing an agentic transformation strategy for biomedical organizations through Researgency.ai, a platform designed to enable scalable, governed deployment of AI agents across research, documentation, and operational workflows. The Company's focus on enterprise security, real-time performance, and seamless integration positions it at the forefront of innovation in the life sciences AI sector.

Kala believes the future of biomedical innovation is in agentic systems.

For more information, visit www.kalarx.com and www.Researgency.ai

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's strategic initiative to build an AI infrastructure platform for the biotechnology industry, plans to develop and deploy the Researgency AI platform both internally and to external clients, expectations regarding the potential benefits of AI-driven analytical tools, plans to reassess historical datasets and identify new therapeutic indications, expectations regarding the AI drug discovery market and industry trends, expectations regarding the Company's ability to generate recurring platform revenue, plans regarding potential partnerships, client deployments, or technology licensing opportunities, expectations regarding the Company's competitive position and the differentiation of its on-premises deployment model, the potential exercise of development continuation or renewal options under the Agreement, and other statements that are not historical facts.

The Company used words like "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions to identify these forward-looking statements. These statements involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance, or achievements to be materially different from those expressed or implied by such statements. Important factors that could cause such differences include, but are not limited to: risks that AI technologies may not produce expected results in drug discovery or development; risks related to the development, deployment, and performance of the Researgency platform; risks that the Company may not successfully attract or retain external platform clients; risks that the platform-as-a-service business model may not generate anticipated revenues; risks that the Company's product candidates may not be successfully developed or commercialized; risks related to the Company's limited cash resources and ability to continue as a going concern; risks that the third-party information contained herein was not accurate at the time it was published and/or does not accurately predict the future; risks related to the Company's ability to raise future capital and the possibility that market conditions may limit the Company's ability to raise capital on favorable terms; risks related to the Company's ability to regain compliance with Nasdaq listing requirements; competition from larger, better-resourced companies including major technology and pharmaceutical companies; dependence on key personnel and third-party technology providers; the accuracy of third-party market forecasts and projections cited herein; risks that the Company may elect not to expand or continue its deployment of the Researgency platform beyond the initial term; risks that Younet may not perform its obligations under the Agreement; and other risks detailed in the "Risk Factors" section of the Company's Annual Report on Form 10-K as they may be revised in the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and other filings with the Securities and Exchange Commission.

Forward-looking statements speak only as of the date of this release, and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:

Avi MinkowitzChief Executive Officer, KALA BIO, [email protected] | www.Researgency.ai

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