Release Details
Cybin Reports Second Quarter Fiscal Year 2026 Financial Results and Recent Business Highlights
- Closed registered direct offering for aggregate gross proceeds of
- On track to report topline data from
- Continues to advance
-The Company’s cash position as at
- Repayment of outstanding convertible debentures to
- Company to host conference call and webcast at
“We are extremely pleased with the strong demand for our recently completed financing,” said Eric So, Interim Chief Executive Officer of
“Across the organization we are focused on a disciplined execution strategy and building a strong foundation leading up to critical clinical milestones in 2026,” said Eric So, Interim Chief Executive Officer of
Recent Business and Pipeline Highlights:
-
Completed enrollment in its
Phase 2 study evaluating CYB004, a proprietary deuterated dimethyltryptamine (“DMT”) program, for the treatment of GAD. - Continues to progress CYB003 through the Phase 3 APPROACH and EXTEND studies. Dosing is currently ongoing in the first pivotal study, APPROACH, which is expected to enroll 220 patients across 45 U.S. clinical sites1. Patient rollovers continue into EXTEND, the long-term extension study.
-
Received approval in
Australia to conduct the EMBRACE® study, the secondPhase 3 study within the PARADIGM program evaluating CYB003, for the adjunctive treatment of MDD. This approval follows other recent regulatory decisions which granted approval to initiate the EMBRACE study inthe United States ,Ireland ,Poland ,Greece and theUnited Kingdom . - The Board of Directors formed a committee to conduct a formal search for a Chief Executive Officer to guide the Company through its next phase of growth and clinical advancement.
- Growing intellectual property portfolio with 100+ granted patents and 250+ pending applications providing protection around lead programs, CYB003 and CYB004, until at least 2041. The portfolio extends beyond these programs to cover patents and applications to key pre-clinical research and discovery programs, supporting competitive flexibility and potential blocking positions within the field. Cybin’s IP strategy focuses on expanding and defending a dominant position within the sector through targeted filings based on continued innovation across its clinical, preclinical, and discovery efforts.
Upcoming Key Milestones and Catalysts1
CYB003 Phase 3 PARADIGM Program in MDD
-
APPROACH™ Study: Dosing is ongoing with expected enrollment of 220 participants across 45 clinical sites in the
U.S. Topline data expected in Q4 20261. -
EMBRACE™ Study: Initiation of enrollment expected in Q4 2025, targeting 330 participants with moderate to severe MDD1. EMBRACE has been granted approval to initiate in
the United States ,Australia ,Ireland ,Poland ,Greece , and theUnited Kingdom . - EXTEND Long-Term Extension Study: Patient rollovers are underway, providing critical long-term safety and durability data.
CYB004 Phase 2 Program in GAD
-
Successfully completed enrollment in
Phase 2 study. Topline data expected in Q1 20261. - Differentiated delivery: Intramuscular delivery mechanisms optimized for clinical and commercial scalability
Second-Quarter Financial Highlights
-
Cash totaled
US$83.8 million as ofSeptember 30, 2025 . -
The Company’s cash position as at
September 30, 2025 after giving effect to the net proceeds of the Registered Direct Offering isUS$248 million , but before adjustment for post quarter events and repayment of the remaining balance outstanding under the Company’s convertible debentures and early repayment fees for a total cash repayment of approximatelyUS$22.8 million . -
Net loss was
US$33.7 million for the quarter endedSeptember 30, 2025 , compared to a net loss ofUS$41.9 million in the same period last year. -
Cash-based operating expenses consisting of research, general, and administrative costs totaled
US$28.5 million for the quarter endedSeptember 30, 2025 , compared toUS$18.2 million , in the same period last year. -
Cash flows used in operating activities were
US$34.5 million for the quarter endedSeptember 30, 2025 , compared toUS$19.1 million in the same period last year.
Conference Call and Webcast Details:
Date:
Time:
Dial-in: 800-245-3047 (
Conference ID: CYBN1113
Webcast: Register for the webcast here
About
With promising class leading data,
Founded in 2019,
Note:
- 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 or forward-looking information within the meaning of applicable securities laws (collectively, “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”, “potential”, “possible”, “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 expectation to advance towards its upcoming data readouts and beyond; the Company’s expectations to report topline data from
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 and six month periods ended
Neither Cboe Canada, nor the
View source version on businesswire.com: https://www.businesswire.com/news/home/20251112814574/en/
Investor Contact:
Astr partners
Managing Director
(908) 578-6478
josh.barer@astrpartners.com
Chief Business Officer
1-866-292-4601
irteam@cybin.com
Source: