Cybin Reports Third Quarter Fiscal Year 2025 Financial Results and Recent Business Highlights

- Launched strategic clinical site partnerships to accelerate PARADIGM, a multinational pivotal Phase 3 program evaluating CYB003 for the adjunctive treatment of major depressive disorder ("MDD") -

- PARADIGM comprises two 12-week randomized, double-blind, placebo-controlled studies (APPROACH$(TM)$ and EMBRACE(TM)) and a long-term extension study (EXTEND), with anticipated combined enrollment of approximately 550 patients -

- APPROACH has been initiated and will enroll 220 participants at more than 40 clinical sites in the United States and Europe -

- Upcoming milestones include topline efficacy data readout from CYB004 Phase 2 study in general anxiety disorder and initiation of EXTEND and EMBRACE pivotal studies of CYB003 around mid-year 2025 -

- CYB003 in development for MDD has a total addressable market of >300 million people worldwide(2) -

- Cash totaled C$136.3 million as of December 31, 2024 -

This news release constitutes a "designated news release" for the purposes of Cybin's prospectus supplement dated February 10, 2025, to its short form base shelf prospectus dated August 17, 2023, as amended December 22, 2023, April 8, 2024 and January 6, 2025.

TORONTO--(BUSINESS WIRE)--February 10, 2025-- 

Cybin Inc. (NYSE American:CYBN) (Cboe Canada CA:CYBN) ("Cybin" or the "Company"), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today reported unaudited financial results for its third quarter ended December 31, 2024, and recent business highlights.

"As we advance our lead clinical programs, CYB003 and CYB004, our focus in 2025 remains on continued successful execution," said Doug Drysdale, Chief Executive Officer of Cybin. "With the initiation of PARADIGM, our multinational pivotal Phase 3 program evaluating CYB003 for the adjunctive treatment of MDD, we look forward to a rigorous investigation and to confirming the data from our Phase 2 study in a larger patient population. We anticipate total enrollment of roughly 550 patients across over 40 sites in the United States and Europe. In addition, given CYB003's Breakthrough Therapy Designation by the U.S. Food and Drug Administration, we see an opportunity to validate our results to-date and to potentially change the treatment landscape in depression away from daily dosing and toward more intermittent treatments".

"Our expanded drug development team has decades of experience overseeing therapeutics through the regulatory process through to launch and are well-versed in the complexities of this type of research. Energized by the potential of these new treatments, we aim to carry forward the momentum from last year's clinical achievements as we plan for the next set of milestones," concluded Drysdale.

Recent Business and Pipeline Highlights:

Launched strategic clinical site partnerships to support PARADIGM. Strategic partnership agreements are expected to facilitate collaboration among sites, cultivate long-term partnerships, enhance efficiency in trial operations, and improve overall site performance. Segal Trials, a privately held company with a network of six research sites throughout South Florida, has been named as the first program member. Segal Trials has extensive experience conducting research trials with an emphasis on psychiatry, neurology, addiction and psychedelics research.

Clinical Program Update

CYB003: Summary of Phase 2 12-Month Efficacy Data in MDD Patients

   -- 
 100% of participants receiving two doses of 16 mg were responders. 
 
 
   -- 
 71% 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. 
 

CYB004: Phase 2 proof-of-concept study in generalized anxiety disorder ("GAD") is underway

   -- 
 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 topline 
      safety and efficacy results expected in the first half of 2025. 
 

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. 
 

Upcoming Clinical Milestones and Future Studies:(1)

CYB003 - Deuterated Psilocin Program

   -- 
 Initiate second pivotal study, EMBRACE, around mid-2025. 
 
 
   -- 
 Initiate long-term extension study, EXTEND, which is expected to begin 
      12 weeks after commencement of APPROACH and EMBRACE, respectively. 
 

CYB004 -- Deuterated DMT Program

   -- 
 Dosing is underway and topline safety and efficacy readout from Phase 2 
      GAD study is expected in the first half of 2025. CYB004 is being 
      developed as a novel intramuscular formulation expected to deliver an 
      experience lasting approximately 90 minutes. 
 

Third-Quarter Financial Information

   -- 
 Cash totaled C$136.3 million as of December 31, 2024. 
 
 
   -- 
 Cash balance excludes prepaid expenses totaling C$22.9 million as of 
      December 31, 2024. 
 
 
   -- 
 With the previously completed public offerings of units of the Company 
      (the "Units") and a combination of the Company's current cash position, 
      and assuming the exercise in full of the warrants issued as part of the 
      Units, the Company has access to over C$203.6 million. 
 
 
   -- 
 Net loss was C$10.5 million for the quarter ended December 31, 2024, 
      compared to a net loss of C$30.3 million in the same period last year. 
 
 
   -- 
 Cash-based operating expenses consisting of research, general and 
      administrative costs totaled C$28.0 million for the quarter ended 
      December 31, 2024, compared to C$17.1 million in the same period last 
      year. 
 
 
   -- 
 Cash flows used in operating activities were C$27.1 million for the 
      quarter ended December 31, 2024, compared to C$26.0 million in the same 
      period last year. 
 

New At-The-Market Equity Program of up to US$100 Million

The Company also announced that it has launched a new at-the-market equity program (the "New ATM Program") to allow Cybin to issue and sell up to US$100,000,000 of common shares (the "Shares") in the capital of the Company from treasury to the public, from time to time, through the Agents (as defined below). All Shares sold under the New ATM Program will be sold in transactions that are deemed to be "at-the-market" distributions as defined in National Instrument 44-102 -- Shelf Distributions, directly through Cboe Canada, the NYSE American LLC (the "NYSE American") or any other "marketplace" (as defined in National Instrument 21-101 -- Marketplace Operation) upon which the Shares are listed, quoted or otherwise traded, at the prevailing market price at the time of sale. Cybin intends to use the net proceeds from sales of Shares under the New ATM Program, if any, for growth opportunities and working capital initiatives.

Distributions of Shares under the New ATM Program, if any, will be made pursuant to the terms and conditions of an "at-the-market equity" distribution agreement (the "New Distribution Agreement") dated February 10, 2025 that the Company entered into with Cantor Fitzgerald Canada Corporation and Cantor Fitzgerald & Co. (collectively, the "Agents").

The New ATM Program will be effective until the earlier of the issuance and sale of all of the Shares issuable pursuant to the New ATM Program and September 17, 2025 unless earlier terminated in accordance with the terms of the New Distribution Agreement. The Company is not obligated to make any sales of Shares under the New ATM Program and there can be no assurance as to when such sales will be completed, if ever. The volume and timing of distributions under the New ATM Program, if any, will be determined in Cybin's sole discretion and in accordance with the New Distribution Agreement. As any Shares distributed under the New ATM Program will be issued and sold at the prevailing market price at the time of the applicable sale, prices may vary among purchasers through the duration of the New ATM Program. The completion of sales of Shares under the New ATM Program will be subject to customary closing conditions, including the listing of such Shares on Cboe Canada and the NYSE American, and any required approvals of each exchange.

The ATM Program is being established, and the sale of the Shares through the ATM Program will be made pursuant to, and qualified by way of a prospectus supplement dated February 10, 2025 (the "Prospectus Supplement") to the Company's short form base shelf prospectus dated August 17, 2023, as amended on December 22, 2023, April 8, 2024 and January 6, 2025 (the "Base Shelf Prospectus") filed with the securities commissions in each of the provinces and territories of Canada. The Base Shelf Prospectus allows Cybin to qualify offerings of Shares, warrants, subscription receipts, units or debt securities, or a combination thereof, up to an aggregate total of C$650,000,000 during the 25-month period, ending on September 17, 2025, that the Base Shelf Prospectus remains effective. The Prospectus Supplement will be filed with the United States Securities and Exchange Commission as a supplement to the Company's registration statement on Form F-10 (File No. 333-284173), which was declared effective on January 14, 2025, in accordance with the Multijurisdictional Disclosure System established between Canada and the United States.

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February 10, 2025 21:48 ET (02:48 GMT)