Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) announced that Michael Cola has stepped down as Chief Executive Officer effective immediately at the request of the Board. Co-founder and Executive Chairman Eric So has been appointed Interim CEO while the company conducts a search for a permanent successor.
The leadership transition is intended to ensure continuity as Helus Pharma advances its clinical pipeline, including the anticipated fourth-quarter topline data readout from the APPROACH trial of HLP003. The company said it remains focused on long-term value creation for patients and shareholders.
Helus Pharma, the commercial operating name of Cybin Inc., is a clinical stage pharmaceutical company developing proprietary novel serotonergic agonists (NSAs) designed to activate serotonin pathways believed to promote neuroplasticity. The company's NSAs aim to address unmet needs in depression, anxiety, and other mental health conditions.
Helus Pharma is currently developing HLP003, a proprietary NSA in Phase 3 clinical development for the adjunctive treatment of major depressive disorder, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Additionally, HLP004, another proprietary NSA, is in Phase 2 for generalized anxiety disorder. The company also has an extensive research portfolio of investigational NSAs.
For more details, the full press release is available at https://ibn.fm/3Gp8X. The company operates in Canada, the United States, the United Kingdom and Ireland. For updates, visit www.helus.com or follow the team on social media. The latest news and updates relating to HELP are available at https://ibn.fm/HELP.
This leadership change comes at a critical juncture for Helus Pharma as it approaches key clinical milestones. The departure of Cola, who was appointed CEO in 2021, may signal strategic shifts or board-level reassessment of the company's direction. However, the appointment of So, a co-founder and executive chairman with deep knowledge of the company's science and strategy, is designed to provide stability.
The APPROACH trial of HLP003 is a pivotal Phase 3 study evaluating the drug as an adjunctive treatment for major depressive disorder. Positive results could be transformative for Helus Pharma, potentially leading to regulatory submissions and commercial launch. The Breakthrough Therapy Designation from the FDA underscores the potential of HLP003 to address a significant unmet medical need.
Investors will be watching closely to see how the interim CEO navigates the company through this period, including any potential changes in corporate strategy or partnerships. The search for a permanent CEO will be a key focus, as the board seeks a leader who can drive the pipeline forward and create shareholder value.
