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Cybin Inc., operating as Helus Pharma, filed a Form 6-K featuring a news update on a White House Executive Order intended to accelerate research, regulation, and patient access for psychedelic-based treatments for serious mental health conditions.
The company states that this policy focus aligns with its portfolio of novel serotonergic agonists. Its lead drug candidate, HLP003, is in Phase 3 clinical development as an adjunctive treatment for major depressive disorder and has received U.S. FDA Breakthrough Therapy designation. A second candidate, HLP004, is in Phase 2 development for generalized anxiety disorder.
The update emphasizes that Helus Pharma continues to advance late-stage trials and broader NSA research while engaging regulators, clinicians, and partners. It also reiterates that none of its investigational products are approved and that extensive clinical and regulatory work remains before any potential commercialization.
Cybin Inc., operating as Helus Pharma, reports a leadership change, with Michael Cola stepping down as Chief Executive Officer effective immediately at the request of the Board. Co-founder and Executive Chairman Eric So has been appointed Interim Chief Executive Officer while a search for a permanent CEO is conducted.
The company reiterates its focus on advancing its clinical pipeline of novel serotonergic agonists, including HLP003 in Phase 3 for adjunctive treatment of major depressive disorder and HLP004 in Phase 2 for generalized anxiety disorder. Helus highlights an upcoming topline data readout from the Phase 3 APPROACH trial of HLP003 expected in the fourth quarter.
Cybin Inc., operating commercially as Helus Pharma, used this report to share that Helus has appointed Dr. Ken Kramer as Senior Vice President, Medical Affairs. He brings more than 25 years of neuroscience medical affairs experience from roles at Bristol Myers Squibb, Karuna Therapeutics, and AbbVie.
The company highlights its focus on developing proprietary novel serotonergic agonists (NSAs) for mental health conditions. Its lead NSA, HLP003, is in Phase 3 clinical development for adjunctive treatment of major depressive disorder and has received Breakthrough Therapy Designation, while HLP004 is in Phase 2 for generalized anxiety disorder.
Cybin Inc. Schedule 13G discloses that Millennium Management LLC, Millennium Group Management LLC and Israel A. Englander report shared beneficial ownership of 2,514,667 common shares, representing 5.0% of the class as of 04/07/2026. The filing is a joint filing under a signed agreement dated 04/09/2026.
Millennium Management LLC, Millennium Group Management LLC and Israel A. Englander reported beneficial ownership of 2,397,721 Common Shares (4.8%) of Cybin Inc.
The filing states these reporting persons acquired beneficial ownership in excess of 5% on 03/19/2026 but ceased to be beneficial owners of more than 5% by the date of this Schedule 13G filing. The submission includes a Joint Filing Agreement dated 03/25/2026.
Cybin Inc., operating commercially as Helus Pharma, filed a Form 6-K highlighting the appointment of Jill Conwell as Chief People Officer, effective immediately. She brings more than two decades of life sciences leadership across organizational strategy, talent development, communications, and investor relations.
Helus Pharma is a clinical stage pharmaceutical company developing proprietary novel serotonergic agonists (NSAs) for mental health conditions. Its lead program HLP003 is in Phase 3 for adjunctive treatment of major depressive disorder with FDA Breakthrough Therapy Designation, while HLP004 is in Phase 2 for generalized anxiety disorder.
Cybin Inc., operating as Helus Pharma, reported positive topline Phase 2 results for HLP004 in generalized anxiety disorder (GAD). In adults with moderate-to-severe GAD who remained symptomatic on standard antidepressant therapy, adjunctive 20 mg HLP004 achieved a mean 10.4-point reduction in Hamilton Anxiety Rating Scale scores at six weeks (p<0.0001), on top of standard of care.
Across the pooled study population, 67% were responders and 39% were in remission at six months. Treatment was generally well-tolerated with no drug-related serious adverse events or suicidality-related safety signals, and the acute drug effects lasted about 90 minutes with most Phase 1 participants ready for discharge within roughly three hours.
Cybin Inc. filed a Form 6-K to correct how certain previously filed documents are linked to its Canadian shelf registration in the United States. The company is now incorporating Exhibits 99.1-99.4 by reference into its Form F-10 registration statement with file number 333-292294.
These exhibits include interim consolidated financial statements and related management discussion and analysis for the three and nine months ended December 31, 2025, along with news releases dated February 10 and February 13, 2026. The filing replaces an earlier, inadvertent cross-reference to a different Form F-10 registration statement (file number 333-289139).
Cybin Inc., operating commercially as Helus Pharma, filed a Form 6-K that incorporates a news release into its Canadian F-10 shelf. The release announces that former Pfizer Executive Vice President and Chief Medical Officer Dr. Freda Lewis-Hall has joined Helus Pharma’s Board of Directors and will chair its Scientific Advisory Committee.
The company highlights her four decades of experience in psychiatry, drug development, and global medical leadership, including roles at major biopharmaceutical companies. The filing also reiterates Helus Pharma’s focus on novel serotonergic agonists, including HLP003 in Phase 3 for major depressive disorder and HLP004 in Phase 2 for generalized anxiety disorder, both aimed at serious mental health conditions.
Cybin Inc., doing business as Helus Pharma, has appointed Michael Cola as Chief Executive Officer, effective February 10, 2026. The company highlights this leadership change as it advances a pipeline of next-generation mental health therapies toward key clinical and corporate milestones.
Cola brings more than 30 years of experience across neuroscience, rare disease, and specialty pharmaceuticals, including leading Shire’s Specialty Pharmaceutical business and serving as President and CEO of Avalo Therapeutics. He has also held senior roles at Astra-Merck, AstraZeneca, and served on boards of Phathom Pharmaceuticals and Sage Therapeutics.