Mr. Gabriel Fahel reports

CYBIN PROVIDES CORPORATE UPDATE AND HIGHLIGHTS POSITIVE REGULATORY SIGNALS FOR PSYCHEDELIC THERAPEUTICS

Cybin Inc. has provided a corporate update.

"It is especially gratifying that, at a time when we are advancing our clinical pipeline programs, with our lead program CYB003 in phase 3 development, the path toward approval and eventual commercialization of psychedelic therapeutics is gaining clarity," said Doug Drysdale, chief executive officer of Cybin. "With our expanded intellectual property portfolio and a number of key partnerships in place, we believe our rigorous research and novel clinical approach can lead to a transformation in how mental health disorders are treated. Now is the time to address the mental health crisis, and we are encouraged by recent sentiment in favour of expediting the regulatory review process for product candidates in development."

Recent corporate highlights:

• Continued to expand its strategic clinical site partnership (SPA) program in support of the phase 3 Paradigm program; the SPA program is designed to facilitate collaboration among sites, enhance efficiency in trial operations and improve overall site performance;
• Partnered with Thermo Fisher Scientific, a world-class manufacturing partner, to provide U.S.-based manufacturing for the CYB003 program; Cybin broadened its existing strong relationship with Thermo Fisher Scientific to include the development of both the drug substance and drug product capsules for CYB003;
• Partnered with Osmind, a leading service provider to psychiatry practices in the United States, with the objective of accelerating commercial preparation for clinical-stage pipeline; Osmind advances psychiatry through technology and services to bring innovative mental health treatments to patients in need; Cybin will leverage Osmind's 800-clinic network, point-of-care software and real-world data to support commercial preparation for its clinical-stage pipeline;
• Continued to expand intellectual property portfolio with two additional U.S. patents supporting lead programs CYB003 and CYB004, bringing the total to over 90 granted patents and over 230 pending applications; the recently issued patents are as follows:
  • U.S. patent 12,291,499 includes pharmaceutical compositions and oral dosage forms within the CYB003 program, with expected exclusivity until 2041;
  • U.S. patent 12,318,477 is expected to provide exclusivity until 2040 and includes claims to novel formulations of DMT (N,N-dimethyltryptamine) and deuterated isotopologues for intramuscular (IM) injection, including CYB004.

Positive regulatory signals and evolving acceptance of potential therapeutic value of psychedelics

Recent statements and hiring decisions by senior U.S. Health and Human Services (HHS) and FDA (U.S. Food and Drug Administration) officials, in addition to continuing signs of bipartisan congressional support, suggest an improved forward regulatory environment for psychedelic medicine and therapies, including the potential for accelerated approval pathways.

The company believes that these developments, together with increased political recognition and public understanding of the science underpinning these programs, have the potential to expedite regulatory pathways and reduce overall risk across its clinical portfolio. Highlights include:

• In a recent interview, FDA commissioner Dr. Marty Makary stated that psychedelic drug review is a top priority and promised an expeditious and rapid review of clinical data.
• Drug-policy lawyer Matthew Zorn has joined HHS as deputy general counsel to work on psychedelics policy. He previously challenged the government on matters such as allowing research on cannabis for veterans with PTSD (posttraumatic stress disorder), preventing tryptamines from being scheduled and fighting for patient access to psilocybin under Right to Try laws.
• Morgan Luttrell (Navy SEAL turned congressman) recently urged the GOP to embrace compounds such as psilocybin, MDMA (3,4-methylenedioxymethamphetamine) and ibogaine to help veterans with PTSD.
• President Trump's new pick for surgeon general, Dr. Casey Means, wrote in a recent book that people should consider guided-psychedelic therapy.
• Cybin's chief executive officer, Doug Drysdale, recently appeared on Fox News and is increasingly sought by media outlets as a trusted commentator.

On June 19, 2025, Mr. Drysdale will speak in a panel discussion focused on the regulatory landscape and next steps for potential commercialization at the Psychedelic Science 2025 Conference taking place from June 16 to June 20, 2025, in Denver, Colo. The panel details are as follows.

Panel title:   The Home Stretch: Pivotal Trials and Preparing for Launch

Date and time:  Thursday, June 19, 2025, at 9:30 a.m. MDT (11:30 a.m. EDT)

About Cybin Inc.

Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental health care by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.

With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long-lasting results. The company is currently developing CYB003, a proprietary deuterated psilocin analogue, in phase 3 studies for the adjunctive treatment of major depressive disorder, and CYB004, a proprietary deuterated N,N-dimethyltryptamine molecule in a phase 2 study for generalized anxiety disorder. The company also has a research pipeline of investigational, 5-HT-receptor-focused compounds.

Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland.

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