Mr. Michael Cola reports
HELUS PHARMA REPORTS THIRD QUARTER FISCAL YEAR 2026 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS
Cybin Inc. (doing business as Helus Pharma) has released unaudited financial results for its third quarter ended December 31, 2025, and recent business highlights.
"The third quarter reflects continued disciplined execution across Helus Pharma's clinical and operational priorities," said Michael Cola, chief executive officer of Helus Pharma. "We are advancing a differentiated, multiasset neuroscience portfolio with programs spanning multiple stages of development and indications. With a strong balance sheet, continued progress across our HLP003 phase 3 and HLP004 phase 2 programs, and a focus on scalable, repeatable clinical architectures, Helus Pharma is well positioned as we move toward upcoming clinical catalysts and long-term value creation."
Recent business and pipeline highlights:
-
Leadership transition completed with the appointment of Michael Cola as chief executive officer to lead the company's transition to a potential first commercial product launch;
- Continued advancement of HLP003, the company's lead proprietary NSA (novel serotonergic agonist), through its phase 3 clinical development program for the adjunctive treatment of major depressive disorder (MDD), including continuing activities across both the Approach and Embrace pivotal studies and the Extend long-term extension study;
- Continued progress in the HLP004 phase 2 program for GAD (generalized anxiety disorder), with study activities supporting an coming top-line data readout in Q1 2026;
- Executed the rebranding to Helus Pharma;
- Reframed the company's focus on engineered serotonergic agonists designed for controlled pharmacokinetics and potential future commercial scalability, which management of the company believes more appropriately reflects the company's transition from a clinical-stage entity to a potential commercial-stage pharmaceutical company;
- Continued expansion and defence of the company's intellectual property portfolio supporting multiple programs and indications and providing protection around lead programs HLP003 and HLP004 until at least 2041, reinforcing long-term differentiation, strategic flexibility and potential blocking position within the field.
Coming milestones and catalysts:
- HLP004 phase 2 program in generalized anxiety disorder:
- Anticipated top-line data readout from the phase 2 study evaluating HLP004 in GAD in Q1 2026;
-
HLP003 phase 3 program in major depressive disorder:
-
Continued execution of the Approach pivotal phase 3 study evaluating HLP003 as an adjunctive treatment for MDD, with top-line data anticipated in Q4 2026;
- Continued execution of the Embrace complementary phase 3 study, which initiated patient enrolment in the prior quarter, designed to reinforce efficacy findings and support the overall evidence package for HLP003 in MDD;
- Continuing patient participation in the Extend long-term extension study, supporting the collection of long-term safety and durability data.
Third quarter financial highlights:
-
Cash totalled $195.1-million as of Dec. 31, 2025, before any adjustments for postquarter events.
- Net loss was $42.7-million (U.S.) for the quarter ended Dec. 31, 2025, compared with a net loss of $7.5-million (U.S.) in the same period last year.
- Cash-based operating expenses consisting of research, general and administrative costs totalled $36.7-million (U.S.) for the quarter ended Dec. 31, 2025, compared with $20-million (U.S.) in the same period last year.
- Cash flows used in operating activities were $31.9-million (U.S.) for the quarter ended Dec. 31, 2025, compared with $18.6-million (U.S.) in the same period last year.
About Cybin Inc. (doing business as Helus Pharma)
Helus Pharma, the commercial operating name of Cybin, is a clinical-stage pharmaceutical company committed to helping minds heal by developing proprietary NSAs: synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity. The company's proprietary NSAs are intended to potentially address the large unmet need for people who suffer from depression, anxiety and other mental health conditions.
With class-leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that aim to provide durable improvements in mental health. Helus Pharma is currently developing HLP003, a proprietary NSA, in phase 3 clinical development for the adjunctive treatment of major depressive disorder that has received breakthrough therapy designation from the U.S. Food and Drug Administration, and HLP004, also a proprietary NSA in phase 2 for generalized anxiety disorder. Additionally, Helus Pharma has an extensive research portfolio of investigational NSAs.
The company operates in Canada, the United States, the United Kingdom and Ireland.
We seek Safe Harbor.
© 2026 Canjex Publishing Ltd. All rights reserved.