Cybin Inc. (HELP) Earnings Call Transcript & Summary

Hello, and welcome to Cybin Inc.'s Annual Meeting of Shareholders. The meeting will now come to order. My name is Eric So, I am the President and Director of Cybin Inc, and I will act as Chair of this meeting. I have appointed Sean Green to act as Secretary of the meeting, Stacy Diocampo of Odyssey Trust Company, will act as scrutineer for the meeting. I would also like to introduce the following officers of Cybin in attendance of this meeting: Doug Drysdale, Chief Executive Officer; Greg Cavers, Chief Financial Officer; paul Glavine, Chief Growth Officer; and Gabriel Fahel, Chief Legal Officer. The meeting is being hosted on Odyssey's virtual shareholder meeting platform. This allows registered shareholders vote and to submit questions and comments to the moderator to be read and addressed during the meeting. If you have a question or comment, please submit it through the system, and we will answer it at the appropriate time. Proof of mailing to the shareholders of record as of the close of business on Monday, July 28, 2025 of the notice of Annual Meeting of Shareholders, together with the management information circular, the form of proxy and the financial statement request card have been filed, and I direct the proof of mailing to be kept by the secretary with the records of this meeting. The notice sets out the various matters to be dealt with at today's meeting. I would suggest that all shareholders have a copy of the notice of meeting and management information circular in front of them as it will be easier to follow the meeting. I'm advised by the scrutineer that there is a quorum present. The scrutineers' report will be available from the Secretary following the meeting. I declare that the meeting is regularly called and properly constituted and as an order -- and is in order for us to proceed with the transaction of business. Before commencing the business of the meeting, I would like to comment on the voting procedure. Each holder of a common share is entitled to 1 vote for each share held by the holder in respect of each matter to be dealt with at the meeting. We will conduct each vote by way of vote cast on Odyssey's virtual platform and those submitted by proxy. I understand that the scrutineer has tabulated all the votes prior to receiving the voting cutoff. If you have previously voted, you do not need to vote again when prompted. By voting again, you will revoke any previous vote made prior to the voting cutoff. We will now open the voting for the resolutions, particulars of the votes cast on each matter may be obtained from the Secretary after the meeting. The first item of business is the [ laying ] before this meeting of the financial statements of the Corporation for the year ended March 31, 2025, and the report of the auditors thereon. A copy of the financial statements and the report of the auditor thereon may be obtained at sedarplus.ca or on Cybin's website on the Investors tab. We would be pleased to deal with any questions relating to the financial statements at the end of the meeting. And the next item of business is the appointment of the auditor. I would ask for a motion to appoint Zeifmans LLP as auditor of the Corporation and authorize the directors of the Corporation to fix the remuneration we paid to the auditor.

My name is Greg Cavers, and I move the motion.

Is there a seconder?

Paul Glavine, and I second the motion.

Is there any discussion or questions submitted from any registered shareholder or proxy holder? For those who have not voted on the resolution, please do so now. Voting on the resolution will close after all resolutions have been put before the meeting. [Voting]

The next item of business is a special resolution setting the number of directors of the Board at 6. An affirmative vote of not less than 2/3 of the vote cast at the meeting is sufficient to pass each such resolution. May I have a motion that passes a special resolution in the setting of the directors of the Board at 6?

My name is Greg Cavers, and I move the motion.

Is there a seconder?

Paul Glavine, I second the motion.

Is there any discussion or questions submitted by any registered shareholder or proxy holder? For those who have not voted on the resolution, please do so now. Voting on the resolution will close after all resolutions have been put before the meeting. [Voting]

We will now proceed to the election of directors. Only persons that have been nominated in accordance with the procedures set out in bylaw #1 of the Corporation shall be eligible for election as directors. The management information circular contains the names of management's nominees to the Board of Directors. I'm advised that nn other nominations for election to the Board were duly received. Therefore, pursuant to bylaw #1 nominations from the floor of the meeting other than management's nominees will not be accepted. I now declare the meeting open for the nomination of directors.

My name is Greg Cavers, and I nominate Theresa Firestone, Grant Froese, Paul Glavine, Eric Hoskins, Mark Lawson and Eric So as directors of the Corporation.

Is there a seconder?

Paul Glavine, I second the nomination.

Is there any discussion or questions submitted from any registered shareholder or proxy holder? For those who have not voted on the resolution, please do so now. [Voting]

Voting is now closed. I'm advised by the scrutineer that each of resolutions put before the meeting has been approved by more than the requisite threshold. Now that the official business of the meeting has been addressed, I request a motion to conclude the meeting.

Greg Cavers, I move that the meeting be concluded.

Is there a seconder?

Paul Glavine, I second the motion.

I declare the formal portion of the meeting is terminated. I will now invite Douglas Drysdale, Chief Executive Officer, to deliver a presentation on behalf of the Corporation's management.

Thank you, Eric. Good morning, everyone. Welcome, and thank you for joining our Annual General Meeting today. Before I deliver my remarks, I'd like to remind everyone that certain statements in this update are forward-looking statements and are prospective in nature. In preparing these forward-looking statements, several assumptions were made by Cybin, and there are risks that actual results obtained by Cybin will differ materially from these statements. Cybin cannot guarantee that any forward-looking statement will materialize, and you are cautioned not to place undue reliance on them. We refer current and potential investors to the forward-looking Information Sections of the company's management's discussion and analysis available at sedarplus.ca and on EDGAR at sec.gov. Forward-looking statements represent Cybin's expectations as of August 18, 2025, except as required by securities laws. Cybin does not undertake any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. This past year has been both exciting and productive. Last year, we characterized Cybin as a soon to be Phase III company. This year, we can say that we are a Phase III company, and that is something that we're extremely proud of. We have long referred to our work as affecting a paradigm shift in the treatment of mental health disorders. And I'm pleased to say that this shift is underway here and now, as is our PARADIGM program, the final stage in the development of CYB003 for patients with depression. Before we get into the details, I'd like to thank you all for your ongoing support of our efforts as we continue to pursue a shared mission of developing truly novel therapies to address the stark unmet need in mental health. Today, I'll provide an overview of our clinical programs and upcoming catalysts as well as a business update. And importantly, I'll share some thoughts on the sea change we're witnessing today in the sector itself. Never before has the political and regulatory environment being so supportive of the efforts of Cybin and others in the space to transform the current standards of care in treating an array of middle health disorders. Let me first take a few minutes to talk about the financing we recently announced at the end of June. The research and clinical development work we do is highly capital-intensive and would not be possible without ample funding. We are sincerely grateful for the efforts of so many who collaborated to close this deal. For us, this financing positions the company to continue to advance our clinical pipeline programs. Notably, we believe that the funding structure creates a powerful catalyst for sustained momentum in EMBRACE, our second Phase III study of CYB003. It's fair to say that this marks an inflection point for Cybin and supports our position as a leader within the sector. The timing is especially opportune for us as the added financial capacity strengthens our ability to continue to advance our lead program, CYB003 and to achieve upcoming value-creating milestones for our clinical programs. Let's start with program achievements for CYB003, our proprietary proprietary deuterated psilocybin molecule in development for the adjunctive treatment of major depressive disorder or MDD. As you may recall, CYB003 demonstrated an unprecedented 71% remission rate in patients with uncontrolled depression at 12 months after just 2 16-miligram doses in Phase II study. Think about that in the context of sustained efficacy and durability advantage over standard of care treatments today, most of which require daily doses. CYB003 received breakthrough therapy designation from the FDA in March of 2024, and that close collaboration with the FDA should expedite the regulatory pathway. Dosing is underway in our Phase III CYB003 PARADIGM program, which comprises of 2 12-week randomized, double-blind, placebo-controlled studies, APPROACH and EMBRACE. And a long-term extension study, EXTEND with anticipated combined enrollment of approximately 550 patients. On August 7, we announced that the clinical trial application, or CTA, was approved by the Irish Medicines Board, acting as the EU reference member state to initiate the EMBRACE study, the second pivotal study in PARADIGM in Ireland, Poland and Greece. This follows fast after the approval we received last month from the U.K. Medical and Healthcare products Regulatory Agency or MHRA to commence EMBRACE in the U.K. as well. This validation from regulatory bodies is extremely important and gratifying. The rise in mental health disorders knows no borders, and we are committed to an international research base to develop new and effective treatments for MDD patients everywhere. The EMBRACE study will enroll 330 participants at approximately 60 clinical sites across the United States, Europe and Australia. Patient dosing an approach will include approximately 45 clinical sites across the United States. 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 to help us collect longer-term data following potential redosing. To help us accelerate our prelaunch goals, we have entered into several strategic collaborations. First, we engaged Thermo Fisher Scientific, a world-class manufacturing partner to provide U.S.-based manufacturing for the CYB003 program. Thermo Fisher is a leading global contract development and manufacturing organization with a successful track record across the manufacturing spectrum. We're pleased to broaden our existing strong relationship with Thermo Fisher to include the development of both drug substance and drug products capsules for CYB003. Second, we partnered with Osmind, a leading service provider to psychiatry practices in the U.S. we intend to leverage Osmind's 800 clinic network, point-of-care software and real-world data to support commercial preparation for our clinical stage pipeline. And third, we've announced additional strategic clinical partnerships -- clinical site partnerships to support PARADIGM. These strategic partnerships are designed to facilitate collaboration among sites, and to leverage the competencies, resources and infrastructures of these key stakeholders with the goal of expediting the development program. Our focus is around execution now with an eye toward regulatory submission preperation, commercial manufacturing readiness and international market expansion planning. And we anticipate Phase III top line readout for CYB003 in 2026. Turning now to CYB004, our proprietary deuterated dimethyltryptamine program in development for the treatment of generalized anxiety disorder, or GAD. Our Phase II proof-of-concept study is a randomized double-blind study evaluating the safety and efficacy of CYB004 in patients with GAD with concomitant antidepressant/anxiolytic treatment and with comorbid depression allowed. It is being conducted at sites in the U.S. and is expected to complete enrollment of the final patient this month in August 2025. Another hallmark of the past year and an ongoing priority for us is vigorous patent protection. At this time last year, we had more than 70 granted patents and over 220 pending applications. I'm pleased to say to share as of today, our intellectual property portfolio comprises more than 100 granted patents and over 250 pending applications. A strong IP portfolio was critical in our field, and we believe it is a true differentiator for us. As I mentioned upfront, we're in the midst of the true sea change in our field. It's not hard -- it's hard not to notice the positive regulatory signals that we've seen recently from U.S. agencies, and expanding media coverage, all of which we believe could expedite regulatory pathways across our clinical stage pipeline. U.S. Department of Health and Human Services Secretary, Robin F Kennedy Jr., has been openly supportive of the sector. Recent statements and hiring decisions by senior HHS and FDA officials in addition to ongoing bipartisan congressional support suggests an optimistic forward regulatory environment for psychodelic medicines and therapies, including the potential for accelerated approval pathways. These developments, together with increased political recognition and public understanding of the science underpinning these programs cast the whole sector in a positive light. This new narrative is game changing and perhaps will lead to the clearing of some of the bottlenecks we encounter in advancing this important work. In addition, the commercial success of esketamine is a very encouraging signal for the entire sector. As reported by J&J, in the second quarter of 2025, esketamine sales totaled $366 million in the U.S. and $414 million worldwide, representing 61% growth year-over-year in the U.S. and an annual run rate of roughly $1.7 billion. I believe that the achievements of our peers benefit us all. For example, we're seeing the continued expansion of infrastructure for this new mental health treatment modality. For the first time, there are networks of certified treatment centers opening up across the U.S., each equipped with observation rooms, trained staff and protocols for managing associated experiences, and we expect many of these capabilities to be directly applicable to our therapies when approved. We believe that advances successes and regulatory progress in 1 area of the field can bolster the entire sector. From research and development to public perceptions, to broadening investor interest and eventually access for patients. In concluding today, let me summarize what I consider to be our key competitive advantages. First and foremost, our clinical achievements with 70% plus remission rates in depression compared to industry standards of around 30%. Add to that, Cybin's proposed approach is dramatically different with just 2 doses annually with the goal to be more effective with a larger effect size and importantly, sustained relief from depression for patients. We have successfully prioritized building an IP fortress, protecting our intellectual property into the 2040s and beyond, and we'll continue to do so. Our recent financing enables us to build on the regulatory momentum from receiving the FDA breakthrough therapy designation. We're well capitalized and with multiple near-term inflection points for our CYB003 and CYB004 programs, we're confident in our position as a leader within our sector. Mental health disorders impact almost 1 billion people around the world. And sadly, that number continues to grow. And that is exactly why we do what we do with such passion. I want to take the opportunity to thank the entire Cybin team for their unwavering efforts to bring these transformative therapeutics to patients who need them and to our directors and our shareholders who are as deeply committed to this mission as we are. There's no better time to be in this game, and I'm confident that in Cybin's ability to win. Thank you all. That concludes my remarks for today.

Thank you, Doug. That concludes the meeting. Thank you for your attendance.