Cybin Reports First Quarter Fiscal Year 2025 Financial Results and Recent Business Highlights
- Phase 3 multinational study of CYB003 expected to begin in late summer 2024 -
- 30 clinical sites selected across
- 12-month efficacy results from Phase 2 study of CYB003 in MDD expected Q4 2024 -
- Additional United States patent granted providing protection for the CYB004 program -
- Strengthened R&D team with additional experienced drug development leaders -
- Cash totaled
This news release constitutes a “designated news release” for the purposes of Cybin’s prospectus supplements each dated August 23, 2023, to its short form base shelf prospectus dated August 17, 2023, as amended December 22, 2023, and April 8, 2024.
“During the recent quarter we continued to move quickly, having achieved meaningful progress on the development of our two lead product candidates: CYB003, our proprietary deuterated psilocybin analog program in development for the adjunctive treatment of Major Depressive Disorder, and CYB004, our proprietary deuterated dimethyltryptamine program in development for the treatment of Generalized Anxiety Disorder. The path towards approval and commercialization for our novel therapeutics is coming into focus as we work efficiently to provide improved outcomes for patients and their families,” said Doug Drysdale, Chief Executive Officer of Cybin.
“To spearhead these programs through the next phases of development, we have hired two talented and experienced drug development experts: Dr. Atul R. Mahableshwarkar, and Dr. Tom Macek, to lead the CYB003 and CYB004 programs, respectively. Both bring in-depth expertise, and we welcome their guidance as we advance toward regulatory approval.”
“Importantly, CYB003, which is in development for the possible adjunctive treatment of MDD, has received
Recent Business and Pipeline Highlights:
Continued progress towards initiation of our Phase 3 multinational study for the CYB003 program in late summer of 2024. The Phase 3 MDD study will include thirty sites in
Strengthened research and development team with two key additions:
- Dr. Atul R. Mahableshwarkar M.D., DLFAPA, Senior Vice President, Clinical Development. Dr. Mahableshwarkar is leading the CYB003 program, Cybin’s proprietary deuterated psilocybin analog program in development for the adjunctive treatment of Major Depressive Disorder (“MDD”). Dr. Mahableshwarkar is a board-certified psychiatrist and accomplished drug development executive with experience in both large global and small startup companies. He brings varied experiences from academia and industry as a site principal investigator for industry-sponsored studies and has submitted several INDs and NDAs leading to drug approvals.
- Dr. Tom Macek, Pharm.D., Ph.D., Senior Vice President, Clinical Development. Dr. Macek is leading the CYB004 program, Cybin’s proprietary deuterated dimethyltryptamine (“dDMT”) program in development for the treatment of Generalized Anxiety Disorder (“GAD”). Dr. Macek brings decades of pharmaceutical industry experience in new drug development across all phases of research (pre-IND to post-approval) across diverse treatment modalities and has submitted or supported several INDs and NDAs/BLAs leading to drug approvals.
Strengthened intellectual property portfolio with additional patent in support of the CYB004 program. On July 23, 2024, the Company was granted US patent no. 12,042,564, providing additional patent protection for the CYB004 program.
Upcoming Clinical Milestones and Future Studies:1
CYB003 - Deuterated Psilocybin Analog Program
- 12-month efficacy data from Phase 2 MDD study expected Q4 2024.
- A multinational, multisite Phase 3 program to commence in late summer of 2024 to further evaluate the safety and efficacy of CYB003 capsules as adjunctive treatment in a larger MDD patient population.
-
30 clinical sites have been selected across the
U.S. andEurope .
CYB004 – Deuterated DMT Program
- Dosing is underway and topline safety and efficacy readout from Phase 2 GAD study is expected around year end 2024, or early Q1 2025. CYB004 is being developed as a novel intramuscular formulation expected to deliver an experience lasting approximately 90 minutes.
First-Quarter Financial Information
-
Cash totaled
C as of June 30, 2024.$183 million -
With the previously announced 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 .$247 million -
Net loss was
C for the quarter ended June 30, 2024, compared to a net loss of$15 million C in the same period last year.$15 million -
Cash-based operating expenses consisting of research, general and administrative costs totaled
C for the quarter ended June 30, 2024, compared to$16 million C in the prior year quarter.$11 million -
Cash flows used in operating activities were
C for the quarter ended June 30, 2024, compared to$27 million C in the same period last year.$11 million -
Cash flows used in financing activities were
C for the quarter ended June 30, 2024, compared to$0.2 million C received from financing activities in the same period last year.$3.5 million
About Cybin
Cybin is a clinical-stage breakthrough neuropsychiatry company on a mission to create safe and effective next-generation therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.
Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens. Cybin is currently developing CYB003, a proprietary deuterated psilocybin analog program for the treatment of major depressive disorder and CYB004, a proprietary dDMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.
Headquartered in
Notes
1. There is no assurance that timelines will be met. Anticipated timelines regarding the initiation, advancement and results of clinical trials are based on reasonable assumptions informed by current knowledge and information available to the Company. See “Cautionary Notes and Forward-Looking Statements”.
Cautionary Notes and Forward-Looking Statements
Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s plans to progress to a Phase 3 trial of CYB003 in summer 2024; the release of 12-month durability data from Phase 2 study of CYB003 in Q4 2024; commencing enrollment at 30 clinical sites across the
These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the three months ended June 30, 2024 and the Company’s annual information form for the year ended March 31, 2024, which are available under the Company's profile on www.sedarplus.ca and with the
Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The
Neither the Cboe Canada, nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.
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Investor & Media Contact:
Gabriel Fahel
Chief Legal Officer
Cybin Inc.
1-866-292-4601
irteam@cybin.com – or – media@cybin.com
Source: Cybin Inc.