Mr. Gabriel Fahel reports

CYBIN RECEIVES UK MHRA APPROVAL TO COMMENCE EMBRACE, A MULTINATIONAL PIVOTAL STUDY EVALUATING CYB003 FOR THE ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER

Cybin Inc. has received approval from the United Kingdom Medical and Healthcare Products Regulatory Agency (MHRA) to commence Embrace, the second pivotal study in Paradigm, the company's phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analogue. The company previously received breakthrough therapy designation from the United States Food and Drug Administration (FDA) for CYB003 for the adjunctive treatment of major depressive disorder (MDD).

"MHRA approval to initiate the Embrace component of our Paradigm program in the U.K. marks an important step forward as we advance our lead program, CYB003, through the regulatory process," said Doug Drysdale, chief executive officer of Cybin. "The agency's decision serves as strong validation of both the quality of our data and the urgent need to develop new and effective therapeutics to treat depression. With expected enrolment of 330 participants suffering from moderate to severe MDD, the Embrace study aims to generate critical late-stage data that, ultimately, may lead to transforming the standard of care for patients in need."

"There are encouraging signs of clinical and commercial success across this sector, along with increasing political and regulatory support. Health expert Dr. Martin Makary, commissioner of the U.S. Food and Drug Administration, has publicly recognized the potential value of these innovative therapeutics and has stated his intention to prioritize and expedite the review process. The commercial success of esketamine is also a positive signal for the entire sector. In the second quarter of 2025, esketamine sales totalled $366-million in the U.S. and $414-million worldwide, representing 61.1-per-cent growth year over year in the U.S., and an annual run rate of roughly $1.7-billion. These positive factors contribute to the credibility and opportunity of the work we are doing at Cybin," concluded Mr. Drysdale.

Embrace study design

Embrace will enroll 330 patients suffering from moderate to severe MDD (MADRS greater than or equal to 24) who are on a stable dose of antidepressant medication but are responding inadequately. Study participants will be randomized 1:1:1 to receive either CYB003 16 milligrams, CYB003 eight mg or inactive placebo. Each study arm will evaluate two doses, administered three weeks apart.

The primary end point will be change in depressive symptoms as measured by change in MADRS from baseline at six weeks after the first dose.

Embrace is the second phase 3 randomized, double-blind clinical trial in the Paradigm program, and is expected to enroll participants at approximately 60 clinical sites across the U.S., Europe and Australia. The first phase 3 trial, Approach, is taking place at approximately 45 clinical sites across the U.S. Participants from Approach and Embrace will have the opportunity to roll over into Extend after completing the 12-week, double-blind, placebo-controlled treatment periods.

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 analog, 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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