HELP

D - CYBIN INC. (0001833141) (Filer)

D - CYBIN INC. (0001833141) (Filer)

6-K - CYBIN INC. (0001833141) (Filer)

6-K - CYBIN INC. (0001833141) (Filer)

Former Intra-Cellular Therapies, Inc. ("Intra-Cellular") executives bring complementary experience in organizational scale-up, central nervous system ("CNS") drug development, regulatory approvals and commercialization Ms. Donohue is the former Chief Human Resources Officer of Intra-Cellular, where she led the company’s people strategy and human resources infrastructure as it transitioned from a clinical to a commercial stage organization of 1,000+ employees Dr. Durgam is a recognized CNS drug-development leader who played a pivotal role in securing multiple U.S. Food and Drug Administration ("FDA") approvals for CAPLYTA® (lumateperone), including in schizophrenia, bipolar depression and a

6-K - CYBIN INC. (0001833141) (Filer)

- Appointed Michael Halstead, former President of Intra-Cellular Therapies, as Chief Executive Officer to lead Helus Pharma through late-stage development and commercialization - - Completed enrollment in the Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder ("MDD"); topline data remain on track for Q4 20261,2   - - Completed Drug-Drug Interaction ("DDI") study demonstrated a favorable DDI profile supporting HLP003 as a potential adjunctive treatment for MDD - - Continued enrollment in EMBRACE, the second pivotal study in the Phase 3 PARADIGM program - - Continued participant rollover into EXTEND to generate long-term safety and durability data - - Completed USD$50 m

SCHEDULE 13G - CYBIN INC. (0001833141) (Subject)

NEW YORK and TORONTO, Aug. 10, 2026 (GLOBE NEWSWIRE) -- Helus Pharma™ (NASDAQ:HELP) (Cboe CA: HELP) (the "Company" or "Helus Pharma"), a clinical-stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists ("NSAs"), today announced that Michael Halstead, Helus Pharma’s Chief Executive Officer, will participate in a fireside chat at the Canaccord Genuity 46th Annual Growth Conference, taking place August 11-12, 2026. The fireside chat will be webcast live on Wednesday, August 12, 2026, at 12:00 p.m. EDT. To register for the webcast, click here. A replay will be available on the Events & Presentations page of Helus Pharma’s investor relations webs

NEW YORK, Aug. 05, 2026 (GLOBE NEWSWIRE) -- USA News Group News Commentary - In biotech, the gap between a promising drug and a commercial success is often bridged by a single thing: the operator who has done it before. Helus Pharma (NASDAQ:HELP) (Cboe CA: HELP), a clinical-stage company developing novel treatments for depression and anxiety, has just brought in exactly that kind of operator, appointing Michael Halstead, the former President of Intra-Cellular Therapies, as Chief Executive Officer, effective immediately. The move lands months before the company's first pivotal Phase 3 data readout, and it places Helus alongside a cohort of companies working to modernize psychiatric treatmen

6-K - CYBIN INC. (0001833141) (Filer)

Former President of Intra-Cellular Therapies, Inc. was instrumental in building and scaling the company, which was subsequently acquired by Johnson & Johnson Experienced executive with a proven track record of guiding pharmaceutical companies through late-stage clinical development and commercialization Appointed as Helus Pharma prepares for topline data readout from APPROACH, the first pivotal Phase 3 Study of HLP003 as an adjunctive treatment for Major Depressive Disorder ("MDD"), expected in Q4 2026 This news release constitutes a "designated news release" for the purpose of the Company’s prospectus supplement dated December 30, 2025, to its short form base shelf prospectus dated Sept

Wells Fargo initiated coverage of Helus Pharma with a rating of Overweight and set a new price target of $16.00

6-K - CYBIN INC. (0001833141) (Filer)

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM ProgramParticipant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability dataAPPROACH topline data readout on track for Q4 2026 1,2HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA")HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a MADRS benchmark of ≤10, with remission rising to 100% using more

Issued on behalf of Helus Pharma (NASDAQ:HELP) (Cboe CA: HELP)NEW YORK and TORONTO, July 21, 2026 /CNW/ -- USA News Group - News Commentary - Depression remains one of the most stubborn problems in modern medicine, and the numbers behind it are staggering. Tens of millions of adults live with major depressive disorder, and the majority never reach full remission on the first medication they try. That persistent treatment gap has drawn a wave of biotech and pharmaceutical companies into what is now one of the most closely watched races in interventional psychiatry, each pursuing a different way to reach patients that current antidepressants leave behind.

Major Depressive Disorder Market Poised for Strong Growth as New Drug Innovations Transform Patient CareNEW YORK, July 21, 2026 /CNW/ -- Market News UpdatesNews Commentary - Globally, Major Depressive Disorder (MDD) is a prevalent mental health condition that has seen an improvement in patient outcomes due to new approaches introduced by pharmaceutical companies. Traditionally, treatments focused on boosting serotonin levels or other neurotransmitters, resulting in long waiting periods for patients to notice any changes, without any assurance of effectiveness. However, there is now a shift towards quicker-acting medications, exploration of new biological targets, and the development of perso

Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data APPROACH topline data readout on track for Q4 20261,2 HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration ("FDA") HLP003 Phase 2 data demonstrated durable efficacy, with a mean ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline 12 months after two 16 mg doses administered three weeks apart, and 100% response and 71% remission rates based on a MADRS benchmark of ≤10, with remission rising to 100% usi

Issued on behalf of Helus Pharma™Eli Lilly's agreement to acquire AtaiBeckley for up to $3.8 billion hands psychedelic medicine its first large-cap validation, and it lands on a late-stage cohort already carrying pivotal data into the back half of 2026, among them Helus Pharma™ (NASDAQ:HELP) (Cboe CA: HELP), which has a Phase 3 readout due in the fourth quarterUSA News Group News CommentaryNEW YORK, July 17, 2026 /CNW/ -- For half a century, psychedelic medicine was the field serious money would not touch. That ended this morning. Eli Lilly and Company (NYSE:LLY) agreed to acquire AtaiBeckley Inc. (NASDAQ:ATAI) for $6.75 per share in cash, roughly $2.8 billion, plus up to $2.50 per share in

6-K - CYBIN INC. (0001833141) (Filer)

D - CYBIN INC. (0001833141) (Filer)

D - CYBIN INC. (0001833141) (Filer)

NEW YORK, June 30, 2026 (GLOBE NEWSWIRE) -- Market News Updates News Commentary - The way Major Depressive Disorder (MDD) is treated is changing faster than it has in years. For decades, most patients relied on traditional antidepressants that often took several weeks to start working—and didn't always help everyone. Today, drug developers are introducing a new wave of treatments designed to work faster, target different areas of the brain, and offer hope to people with treatment-resistant depression. Researchers are also exploring innovative approaches, including NMDA receptor therapies, orexin-targeting drugs, and other next-generation medicines that could significantly improve patient o

6-K - CYBIN INC. (0001833141) (Filer)

- Recently closed $50 million underwritten offering reinforces strong institutional investor conviction and bolsters balance sheet for execution of second Phase 3 HLP003 trial1,2,3, EMBRACE, for potential U.S. FDA New Drug Application in 20281,2,3 - - Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder ("MDD") has surpassed 88% enrollment and is on track for topline data readout in Q4 20262,3 - - HLP003 Phase 2 data demonstrated durability at 12 months following two 16mg doses, with 100% response and 71% remission based on a MADRS benchmark of ≤10, with remission rising to 100% based on recent peer benchmarks of ≤124,5 - - Reported topline results in Phase 2 signal detec