Helus Pharma Reports FY26 Results with $157.3M Cash
In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on earnings results, a psilocybin export and analyst views.HELUS PHARMA REPORTS FY26 RESULTS:On Monday, Helus Pharmareported awhich compared to a loss per share of ($4.04) for FY25. Cash totaled $157.3M as of March 31.."Over the past year, Helus Pharma has strengthened its position as a segment-leading, clinical-stage pharmaceutical company, advancing HLP003 toward a critical Phase 3 readout in 4Q26 and progressing HLP004 to its next study design by the end of 3Q26," said Eric So, Interim CEO. "We are pleased to report that our Phase 3 APPROACH study has surpassed 88% enrollment, with recruited participants at approximately the same level of baseline severity as in Phase 2. With topline data anticipated later this year, Helus Pharma is at an inflection point as we move toward commercialization, subject to regulatory approval. Our recently closed $50M underwritten offering represents a strong vote of confidence in our clinical strategy from top-tier institutional investors and bolsters our balance sheet for execution of our second Phase 3 HLP003 trial, EMBRACE, with potential U.S. FDA New Drug Application in 2028."Canaccord lowered the firm's price target on Helus Pharma to $42 from $45 and kept a Buy rating on the shares. The firm noted its lead asset, HLP003, a deuterated psilocin analog, is in a Phase 3 program for adjunctive treatment of major depressive disorder. The firm sees significant upside potential on APPROACH Phase 3 data in 4Q26 for HLP003.OPTIMI COMPLETES PSILOCYBIN EXPORT:Optimi Healthannounced Monday the completion of its latestto Australia, marking its third commercial shipment since the September 2025 launch of its 5mg capsules. The shipment included 1,000 capsules, which are being prescribed in Australia for treatment-resistant depression, an indication for which regulated patient access is available."We are proud to be among the few Nasdaq-listed companies commercially supplying psilocybin to patients with treatment-resistant depression outside of clinical trials," said Dane Stevens, CEO and Co-Founder of Optimi. "Our medicine is produced start to finish in Canada and shipped to pharmacy partners globally, and we are seeing expanding reimbursement coverage from both private and public insurers. We believe Australia is providing an early model for how naturally derived psilocybin can be safely prescribed for TRD in real-world practice, and we are not aware of any serious adverse events reported since inception based on data collected through December 31, 2025."DEFINIUM PRICE TARGET LOWERED:Canaccord lowered the firm's price target on Definium Therapeuticson the shares. The firm noted the company recently reported stellar Phase 3 data from its Emerge trial for DT120, LSD d-tartrate orally-disintegrating tablet/ODT, for MDD, which was greeted enthusiastically by investors leading the company to raise about $805M on the back of the news. They adjusted the model on the recent capital raise and the increased share count.COMPASS PRICE TARGET RAISED:Canaccord raised the firm's price target on Compass Pathwaystoon the shares. The firm said they believe shares are significantly undervalued as they head into additional Phase 3 data for COMP360 for TRD in early 3Q26, completion of a new drug application in 4Q26, and potential approval.SILO ENGAGES RESYCA FOR SPC-15 STUDY:Silo Pharmaannounced Monday that it has engaged its drug-device development partner Resyca to conduct aused for nose-to-brain delivery of SPC-15, the company's lead intranasal prophylactic treatment for post-traumatic stress disorder. Resyca's patented Soft-Mist Nasal Spray system is designed for targeted nose-to-brain drug delivery, enabling molecules to bypass the blood-brain barrier. Silo believes this approach has the potential to increase drug concentrations in the brain while reducing systemic exposure, potentially enabling faster therapeutic onset and an improved safety profile. Silo's robustness study will evaluate device performance consistency during expected use and assess formulation stability of SPC-15 formulations over a 30-day period."We believe this robustness study represents another important step toward initiating our first-in-human clinical program for SPC-15," said Eric Weisblum, CEO. "Together with our previously completed preclinical studies, these data are expected to support our planned FDA Type C meeting request, where we intend to obtain regulatory guidance on our IND strategy and Phase 1 clinical trial design."CLEARMIND GRANTED U.S. PATENT:Clearmind Medicineannounced Monday that it has beenNo. 12,357,590, titled "BINGE BEHAVIOR REGULATORS", by the United States Patent and Trademark Office. This latest patent builds directly on the company's previously issued U.S. Patent No. 12,350,242 and further strengthens its intellectual property protection around the MEAI molecule and related 2-aminoindan derivatives for regulating binge behaviors, including excessive drinking, eating, and other compulsive disorders.OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include AtaiBeckley, Grey Matters Health, BetterLife, Bright Minds, Enveric Biosciences, Filament Health, GH Research, Incannex, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Psyence Group, Revive Therapeuticsand Sibannac.
