Cybin Inc. (HELP) Earnings Call Transcript & Summary

Hello, and welcome to Cybin Inc.'s Annual and Special Meeting of the Shareholders. The meeting will now come to order. My name is Eric So, I'm the President and a Director of Cybin Inc. and I will act as Chair of the meeting. I've appointed Sean Green to act as Secretary of the meeting, Stacy Diocampo of Odyssey Trust Company will act as scrutineer for the meeting. We'd also like to introduce the following officers and directors of Cybin in attendance of this meeting: Douglas Drysdale, Chief Executive Officer; Greg Cavers, Chief Financial Officer; Paul Glavine, Chief Growth Officer. The meeting is being hosted on Odyssey's virtual shareholder meeting platform. This allows registered shareholders to vote and to submit questions and comments to the moderator to be read out and addressed during the meeting. If you have a question or comment, please submit it through the system, and we'll answer it at the appropriate time. Proof of the mailing of shareholders of record as of the date of business -- close of business on Monday, July 15, 2024, of the notice of Annual and Special Meeting of the shareholders, together with the management information circular, the form of proxy, any financial statement request card have been filed, and I direct, the [ preferred ] 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 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 scrutineer's report will be available from the Secretary following the meeting. I declare that the meeting is regularly called and properly constituted and it is in order for us to proceed with the transaction of business. Before commencing the business of the meeting, I'd 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 of the votes received prior to 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 voting cutoff. We'll now open the voting for the resolutions, [indiscernible] of the votes cast on each matter may be obtained from the Secretary after the meeting. The first item of business is the line for this meeting and the financial statements of the corporation for the year ended March 31, 2024, and the report of the auditor thereon. Copies 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'd be pleased to deal with any relevant questions concerning the financial statements at the end of the meeting. 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 be paid to the auditor.

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

Is there a seconder?

My name is Paul Glavine and I second the motion.

Is there any discussion or questions submitted from any registered shareholder or proxy holder? 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'll now proceed to the election of directors. Only persons who have been nominated in accordance with the procedures set in by-law 1 of the corporation will be eligible for election of directors. The management information circular contains the names of management's nominees to the Board of Directors. I'm advised that no other nominations for election to the Board were duly received, therefore, pursuant to by-law 1, nominations from the floor of the meeting other than management 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, Eric So and George Tziras as Directors of the Corporation.

Is there a seconder?

My name is Paul Glavine, and 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 on a resolution will close after all resolutions have been put before for the meeting. [Voting]

The next item in business is a special resolution approving the consolidation of the issued and outstanding common shares of the Corporation by a ratio to be determined by the directors of the Corporation of up to 50:1, the text of the resolution is set on Page 32 of the management information circular, an affirmative vote of at least 66 and 2/3 of the votes cast at the meeting is sufficient to pass such resolution. May I have a motion to pass as a resolution, the approval of the consolidation of the issued and outstanding common shares of the Corporation by a ratio of up to 50:1 as described in the management information circular.

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

Is there a seconder?

My name is 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 the business is the resolution authorizing and approving certain amendments to the equity incentive plan of the Corporation. The text of the resolution is set on Page 34 of the Management Information Circular. Whole text of the amended equity incentive plan is attached to the management information circular as described as -- sorry, as set on Schedule B. Affirmative vote of the majority of the votes cast at this meeting is sufficient to pass such a resolution. May I have a motion to pass [ off ] the resolution, the approval of certain amendments to the equity incentive plan of the Corporation as described in the management information circular.

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

Is there a seconder?

My name is Paul Glavine and I second the motion.

Is there any discussion or questions submitted from any registered shareholder or proxy holder? 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 resolution authorizing and improving certain amendments to the shareholder rights plan of the Corporation. The text of the resolution is set on Page 41 of the management information circular. Whole text of the amendment and restated as the full text of the amended and restated shareholder rights plan is attached to the management information circular and schedule E. An affirmative vote of the majority of votes cast at the meeting and the majority of votes cast by independent shareholders, as such term is defined in the Corporation's amended and restated shareholder rights plan is sufficient to pass such resolution. As of the record date based on publicly available information and to the knowledge of the Corporation, there are no holders of common shares in Corporation that are not independent shareholders. May I have a motion to pass the resolution, as a resolution the approval at certain amendments to the shareholder rights plan of the corporation as described in the management information circular.

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

And there is a seconder?

My name is Paul Glavine, and I second the motion.

Is there any discussion or questions submitted from any registered shareholder or proxy holder? 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 resolution authorizing and improving certain amendments to outstanding common share purchase warrants of the Corporation. The text to the resolution is set on Page 43 of the Management Information Circular. I affirm the vote of the majority of the votes cast by [ the interested ] shareholders at the meeting are sufficient to pass such resolution. May I have a motion to pass as a resolution, the approval of certain amendments to the outstanding common share purchase warrants of the corporation as described in the management information circular.

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

Is there a seconder?

My name is 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]

Voting is now closed. I've been advised by the scrutineer that each of the 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 and I second the motion.

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

Thank you, Eric. Before I get started with 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 statements will materialize, and you are cautioned not to place undue reliance on them. We refer current and potential investors to the forward-looking information section of the company's management discussion and analysis available at sedarplus.ca and on EDGAR at sec.gov. Forward-looking statements represent Cybin's expectations as of August 27, 2024, 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. Good morning, everyone, and thank you for joining our Annual General Meeting. On behalf of all of us at Cybin, I'd like to express our sincere gratitude for your ongoing support of our mission and the work that we do. We have made remarkable progress in the past year as we pioneer potentially life-changing therapies that address multiple mental health disorders. Mental health disorders impact almost 1 billion people around the world, and that number, unfortunately, is growing. One in five of us will experience a mental health disorder this year with one in two of us having a mental health issue at some point in our lifetime. This means that every one of us on this call know someone affected by a mental health condition. In the U.S., a staggering 40 million adults are taking SSRIs, treatments that are known to be ineffective for the majority of patients with chronic daily side effects that often require additional treatment. For the past 40 years, we've been treating the signs and symptoms of these disorders but in the near future, we may actually, for the first time, be able to change the course of these diseases and provide lasting remission for many patients with plans to initiate our Phase III pivotal program in late summer of 2024, we believe that we're on the cusp of breakthroughs that have the potential to redefine standard of care for the millions of sufferers around the world. These next few months, in particular, are shaping up to be an exciting and transformational period for us as we anticipate sharing our 12-month Phase II efficacy data for CYB003 in depression and initiating our Phase III pivotal program later followed by a Phase II top line safety and efficacy data for CYB004 around year-end or early quarter one 2025. Today, I'll share with you the strides we've made across our clinical programs, how Cybin's approach is differentiated and how we're navigating the regulatory landscape. I'll also provide some context around our efforts to enhance Cybin's visibility. Quite simply, in our sector, the race to complete Phase III is on. And I'm proud to say that Cybin, once considered an underdog, is now seeking a top-tier position among peers. Let's start with our lead program, CYB003, a proprietary deuterated psilocybin analog in development for the adjunctive treatment of major depressive disorder, or MDD. Our Phase II study delivered the most impressive remission rates in the sector with 75% of MDD patients still in remission at 4 months after just 2 doses of CYB003. We believe these to be truly remarkable results when compared to the current standard of care, and moving from Phase II to Phase III program is where things get really exciting as you move from theory to practice. Earlier this month, we had a type B initial breakthrough therapy meeting with the U.S. FDA in Washington, D.C. Following this productive meeting, we expect to commence our Phase III pivotal program in late summer. We have selected 30 clinical sites across the United States and Europe based on 2 key criteria: one, prior experience running psychedelic clinical trials; and two, having a controlled substance license in place with the aim of accelerating site initiation and recruiting. The recent headlines regarding the CRL received by Lykos for its MDMA product candidate have generated questions about the future of other psychedelic drugs. This was a big moment for our sector with all eyes watching in the aftermath of the FDA's decision. That said, with our strong Phase II data, FDA support through Breakthrough Therapy Designation and a clear regulatory road map, we remain confident as we enter this next phase of investigation. Our Phase III pivotal program design, which is based on dialogue and aligned with the FDA will implement multiple measures to attempt to mitigate the risk of functional unblinding. Our program will include a study with a 3-arm design with a high dose, mid-dose and placebo arm. Patients will not know they received the therapeutic high-dose or the subtherapeutic mid-dose, thus mitigating the unblinding to an extent and addressing potential expectancy buyers. In addition, the study will use remote, independent and blinded raters, who will not have any information on the dose received or the participants' dosing experience. Further, the reporting of effects during the dosing session will be firewalled to ensure that the study team stays blinded. Our intention is to recruit participants who are largely psychedelic naive to reduce the impact of expectancy bias. The studies will assess long-term efficacy with data points up to 1-year to outlast any potential expectancy effects. And finally, the study will include manual and real-time AI screening of monitoring sessions to ensure monitor fidelity and patient safety. With the combination of these studies, we expect to collect efficacy data that will provide a picture of relapse rates, time to redosing and other factors. We're eager to initiate this next phase of clinical development and to build on the positive impact of CYB003 to date, including rapid onset, short duration of effect and importantly, durability of response and remission rates. Importantly, for CYB003, we expect to report 12-month efficacy data from the Phase II MDD study in the fourth quarter of this year. Think about that, we'll see what portion of patients are still responding to treatment 12 months after just 2 doses of CYB003. We believe there is potential for a paradigm shift in the way we treat depression at a time when more effective treatment options are so desperately needed. These encouraging findings together with the granting and Breakthrough Therapy Designation by the FDA, reinforce our enthusiasm for the first ever adjunctive Phase III deuterated psilocybin analog program globally. We hope that a rigorous Phase III program will ultimately lead the regulatory approval and commercial launch. Turning now to CYB004, our proprietary deuterated dimethyltryptamine program in development for the treatment of generalized anxiety disorder, or GAD, where there is a massive unmet need. GAD is a life-threatening condition, which we believe has the potential for breakthrough therapy status. With anxiety disorders affecting some 18% to 19% of the population, this is the largest population of any mental health conditions. We believe current treatments are inadequate, as 50% of patients with GAD do not respond the first-line treatment with antidepressants such as SSRIs and SNRIs. Furthermore, 57% of patients with anxiety diagnosis do not adhere to antidepressant treatment after 6 months. Currently, we are progressing our Phase II study of CYB004, and dosing is underway in a 36-patient study. CYB004 is a short duration of treatment from a single intramuscular administration, and we believe has the potential to provide rapid and sustained benefits. We expect to share top line safety and efficacy data around year-end or early quarter one 2025. We are very excited about demonstrating proof-of-concept data for both of these programs. With our DMT program fast following our CYB003 program, we believe we are differentiating ourselves from our peers and establishing a leadership position. Looking ahead, we're also exploring potential future opportunities for our diverse portfolio in targeting additional neuro neuropsychiatry indications with high unmet need, potentially affecting over 100 million people in the U.S. alone. Two other efforts I'll touch on here are: one, our focus on strengthening our intellectual property portfolio; and two, broadening our clinical research team as we enter this next critical phase of evolution as a drug development company. With regards to IP, our patent portfolio now includes more than 70 granted patents and over 220 pending applications. I can't overstate enough the importance of robust patent protection as we continue along the pathway to regulatory approvals. We have also expanded our R&D team with the addition of 2 highly experienced drug development leaders, Dr. Atul Mahableshwarkar, who is leading the CYB003 program; and Dr. Tom Macek, who is leading the CYB004 program. Both individuals bring a wealth of big pharma and CNS experience, including overseeing large, complex global Phase III trials that we expect will benefit our programs at this pivotal time. One of the items that shareholders were asked to vote on today was authority for the company to institute a share consolidation. We sought this authorization in order to enable new institutional fund and wealth managers and broad-based and targeted indices to participate in Cybin stock ownership. At present, these groups are prevented from buying shares due to internal limitations related exclusively to share price. As we continue to [ share ] chip away as some of the stigma attached to psychedelic-based treatments. It's heartening the companies like Cybin are now a legitimate longer play for investors, and we aim to appeal to as many new investors as possible. When you consider the staggering number of people who faced one or more of these often devastating disorders with more than 300 million people worldwide suffering from depression alone. It's clear why the need for improved therapeutic options is so dire. Culturally, today, there is more understanding and acceptance of the potential benefits of psychedelic-based treatments. And the political and regulatory landscapes are more supportive as well. Our team is working tirelessly to progress our 2 most advanced programs, CYB003 and CYB004, while also investigating other indications beyond MDD and GAD. These are new boundaries we are pushing and we believe we have the rigor and the scientific knowledge to be first to market with truly innovative improvements to the current treatment landscape. With a cash balance of $183 million as of June 30, 2024, we are well capitalized for this next phase of our evolution into a late-stage clinical development company. It's clear to us now that although the science and the efficacy of psychedelic compounds is compelling, only the best companies will succeed. It takes tremendous rigor and excellent execution to steer through the complexities of drug development. As a health care investor myself, I will always bet on a phenomenal management team over simply a great idea. Cybin has consistently delivered on its clinical milestones, supported by what we believe is the strongest team in the sector, and we expect to continue to do so. We truly see a bright future for Cybin and the potential to finally change the course of disease with these treatments, leading the way to transforming the mental health treatment landscape. As always, we appreciate the support and commitment from our shareholders. Thank you very much. So that concludes my remarks. We will now address questions that have been received for registered shareholders through Odyssey's virtual meeting platform. If you have a question or comment, please submit it through the system now. There appears to be no questions at this time. That concludes the question-and-answer period.

That concludes the meeting. Thank you all for attending.