Mr. Doug Drysdale reports

CYBIN HIGHLIGHTS 2024 ACCOMPLISHMENTS AND UPCOMING MILESTONES FOR 2025

Cybin Inc. has provided a year-end summary of its key accomplishments in 2024 and upcoming milestones for 2025.

"In 2024, we made significant progress toward our goal of transforming the mental health treatment landscape," said Doug Drysdale, chief executive officer of Cybin. "Our clinical pipeline of tryptamine serotonin receptor agonists -- notably CYB003, our proprietary deuterated psilocin program in development for the adjunctive treatment of MDD, and CYB004, our deuterated dimethyltryptamine, in intramuscular (IM) form being developed for the treatment of GAD -- achieved several critical benchmarks.

"It's noteworthy that in March, 2024, CYB003 received FDA breakthrough therapy designation. Among its many benefits, this designation provides an expedited review pathway and the potential to accelerate drug development timelines. It also includes all 'fast-track' program features and acknowledges the significant unmet medical need for more effective treatments of MDD. This is especially gratifying in light of our phase 2 study results of CYB003 in MDD, which showed remarkable efficacy at 12 months, including a 100-per-cent response rate and a 71-per-cent remission rate among participants who received two 16 mg doses. With these outstanding findings in hand, we initiated Paradigm, our multinational pivotal phase 3 program, evaluating CYB003 in MDD patients. We also commenced our phase 2 proof-of-concept study of CYB004 in GAD. I'm proud of our research and development team and the tremendous progress made in a relatively short amount of time.

"Looking ahead, we are excited about Cybin's next phase of investigation and growth and for the upcoming milestones, including a readout of top-line efficacy data from our CYB004 phase 2 GAD study in the first quarter of 2025 and the initiation of the Extend and Embrace components of our phase 3 Paradigm program," concluded Mr. Drysdale.

2024 highlights:

CYB003

• Announced unprecedented 12-month efficacy data from the completed phase 2 study of CYB003;
• 100 per cent of participants receiving two doses of 16 milligrams were responders;
• 71 per cent of participants receiving two doses of 16 mg were in remission;
• Mean change from baseline in MADRS was approximately 23 points after two doses of 16 mg;
• Initiated Paradigm, a multinational pivotal phase 3 program evaluating CYB003 for the adjunctive treatment of MDD;
• Paradigm comprises two 12-week randomized, placebo-controlled studies (Approach and Embrace) and a long-term extension study (Extend):
  • Approach has been initiated and will enroll 220 participants at 36 clinical sites across the United States and Europe; top-line results expected in 2026;
  • Embrace will enroll 330 participants at sites across the U.S. and Europe and is expected to commence by mid 2025;
  • Extend is expected to begin 12 weeks after commencement of Approach and Embrace, respectively.
• Appointed senior clinical team leaders and expanded its clinical operations team in support of its Paradigm program. The new team members provide significant expertise and decades of experience across critical domains that are integral to the pivotal phase 3 program;
• Received additional U.S. patent in support of its CYB003 breakthrough therapy program. The patent is expected to provide exclusivity until at least 2041 and includes claims to pharmaceutical compositions within the company's proprietary deuterated psilocin analogue program. This brings the total number of granted patents to over 70, with more than 220 patents currently pending.

CYB004

• Initiated phase 2 proof-of-concept study of CYB004 in GAD;
• The phase 2 study is a randomized, double-blind study evaluating the safety and efficacy of CYB004 in participants with GAD, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed;
• The phase 2 study is being conducted at sites in the U.S., with top-line safety and efficacy results expected in Q1 2025.

Presented two posters at the American College of Neuropsychopharmacology (ACNP) meeting. The data presented include 12-month efficacy results from the company's phase 2 study of CYB003, its deuterated psilocin program, in MDD, which showed durable response and remission rates at 12 months, in addition to results from a completed phase 1b study exploring drug-drug interactions between N,N-dimethyltryptamine (DMT) and selective serotonin reuptake inhibitors (SSRIs), in MDD patients.

CYB005

• Announced grant of first U.S. composition of matter patent in support of its CYB005 phenethylamines program. Cybin is investigating novel molecules within the CYB005 program at non-hallucinogenic doses for a range of central nervous system disorders and continues to explore non-hallucinogenic neuroplastogens within its broader discovery pipeline.

First half 2025 expected milestones

• Top-line efficacy data readout from CYB004 phase 2 GAD study in Q1 2025;
• Initiate Extend and Embrace pivotal studies of CYB003.

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 industry leading 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.

We seek Safe Harbor.