Compass Pathways plc Depositary Receipt

Issued on behalf of Cybin D/B/A Helus Pharma

USANewsGroup.com News Commentary

VANCOUVER, BC, March 9, 2026 /PRNewswire/ -- The central nervous system therapeutics sector is approaching a commercial inflection point as multiple candidates advance through late-stage trials and regulatory milestones accumulate¹. The Drug Enforcement Administration raised its 2026 production quotas for controlled research compounds by 67%, reflecting expanding clinical trial activity across the therapeutics landscape². Five companies are working to translate that momentum into approved treatments: Helus Pharma (NASDAQ: HELP), Compass Pathways (NASDAQ: CMPS), AtaiBeckley (NASDAQ: ATAI), Definium Therapeutics (NASDAQ: DFTX), and GH Research (NASDAQ: GHRS).

The World Health Organization estimates that depression and anxiety cost the global economy more than $1 trillion annually in lost productivity³. Treatment-resistant depression alone affects roughly 30% of patients diagnosed with major depressive disorder, fueling demand for novel mechanisms that can deliver rapid, durable therapeutic responses where traditional antidepressants have failed⁴. The pipeline is moving to meet it, and pharmaceutical capital is following.

Helus Pharma™ (NASDAQ: HELP) is a clinical-stage pharmaceutical company developing novel serotonergic agonists for serious mental health conditions, including major depressive disorder and generalized anxiety disorder.

Helus announced topline results from a Phase 2 signal detection study evaluating HLP004 as a potential adjunctive treatment for adults with moderate-to-severe generalized anxiety disorder who remained symptomatic despite ongoing standard-of-care antidepressant therapy. GAD affects more than 20 million adults in the United States, and no adjunctive pharmacologic treatment for the condition has ever been approved.

In the study, 36 patients were randomized to HLP004 20 mg or 2 mg and received two intramuscular doses three weeks apart. Patients receiving 20 mg adjunctive to standard of care achieved a mean HAM-A reduction of 10.4 points (p<0.0001) at six weeks. At six months, the pooled study population showed 67% responders and 39% remitters. Acute drug effects lasted approximately 90 minutes, with most participants ready for discharge within three hours.

"Patients living with generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments," said Michael Cola, CEO of Helus Pharma. "We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients."

"These Phase 2 results support the continued development of HLP004, and I am encouraged by the magnitude of improvement observed over standard of care treatments, together with the rapid onset and short in-clinic treatment experience for this patient population with limited options," noted Dr. Andrew Cutler, Clinical Professor of Psychiatry at SUNY Upstate Medical University and Senior Advisor to Helus Pharma.

Helus also recently appointed Dr. Freda Lewis-Hall to its Board of Directors and as Chair of the company's Scientific Advisory Committee. Lewis-Hall served for more than a decade on Pfizer's Executive Leadership Team as Executive Vice President and Chief Medical Officer. During her tenure, she helped lead the spinout of SpringWorks Therapeutics, which was later acquired by Merck KGaA for approximately $3.4 billion.

"What distinguishes Helus Pharma is its disciplined approach at the intersection of rigorous science, a thoughtfully advancing clinical portfolio, and focused execution in areas of significant unmet need in mental health," said Dr. Lewis-Hall.

Originally founded as Cybin in 2019, the company rebranded to Helus Pharma in January 2026 and began trading on the NASDAQ under the ticker HELP. The company holds over 350 filed patents with more than 100 already granted, providing protection around its lead programs through at least 2041.

The company's lead asset HLP003, a proprietary oral compound granted FDA Breakthrough Therapy Designation, is advancing through two pivotal Phase 3 studies for the adjunctive treatment of major depressive disorder.

Phase 2 data on HLP003 demonstrated 100% response rates and 71% remission at 12 months after just two 16 mg doses, with an approximately 23-point reduction in MADRS scores.

The APPROACH pivotal Phase 3 study has topline data anticipated in Q4 2026, while the complementary EMBRACE Phase 3 study and EXTEND long-term extension study continue to progress. Helus reported US$195.1 million in cash as of December 31, 2025, supporting continued advancement across its multi-asset clinical pipeline.

CONTINUED… Read this and more news for Helus Pharma at:

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In other industry developments and happenings in the market include:

Compass Pathways (NASDAQ: CMPS) reported positive results from two pivotal Phase 3 trials evaluating COMP360, a synthetic psilocybin compound, in patients with treatment-resistant depression. The larger trial, COMP006, enrolled 581 participants and demonstrated a highly statistically significant reduction in symptom severity, with a p-value below 0.001 and a mean treatment difference of 3.8 points on the MADRS depression scale at Week 6. The results replicate findings from the first Phase 3 trial, COMP005, which showed a mean difference of 3.6 points (p<0.001).

"COMP360 has demonstrated a highly differentiated profile for treatment-resistant depression, with rapid and durable effects in patients facing significant unmet need," said Kabir Nath, CEO of Compass Pathways.

Across both Phase 3 studies, 39% of participants receiving the 25 mg dose achieved a clinically meaningful reduction in depression scores at Week 6, with durable effects observed through 26 weeks after just one or two administrations. Most treatment-emergent adverse events were mild or moderate, resolving within 24 hours. COMP360 is the first classic psychedelic to achieve two highly statistically significant Phase 3 readouts in treatment-resistant depression. The company has submitted a request to the FDA to discuss a rolling New Drug Application submission beginning in Q4 2026.

AtaiBeckley (NASDAQ: ATAI) announced a successful FDA End-of-Phase 2 meeting for BPL-003, clearing the path for Phase 3 initiation in treatment-resistant depression targeted for Q2 2026. The FDA provided clear guidance aligning with the company's Breakthrough Therapy Designation granted in October 2025, enabling a Phase 3 program designed for real-world interventional psychiatry with two-hour in-clinic sessions and few treatments per year.

"This feedback builds on our compelling Phase 2b data as well as the Breakthrough Therapy Designation granted to BPL-003 and firmly positions us to advance a robust Phase 3 clinical program," said Srinivas Rao, M.D., Ph.D., Co-Founder and CEO of AtaiBeckley.

BPL-003, a nasal spray formulation, demonstrated statistically significant antidepressant effects at 8 mg and 12 mg doses in Phase 2b trials, with rapid and durable responses sustained out to Week 8. The company, formed through the 2025 merger of atai Life Sciences and Beckley Psytech, also expects topline data in H2 2026 from its Phase 2 study of VLS-01, a DMT buccal film for treatment-resistant depression, enrolling 142 patients. AtaiBeckley recently redomiciled to the United States, was added to the NASDAQ Biotechnology Index, and reports a cash runway extending into 2029, providing financial stability through multiple anticipated clinical catalysts.

Definium Therapeutics (NASDAQ: DFTX), formerly MindMed, reported full-year 2025 financial results, highlighting $411.6 million in cash, cash equivalents, and investments sufficient to fund operations into 2028. The company rebranded in January 2026 to reflect its focus on a late-stage psychiatry pipeline anchored by DT120 ODT, a lysergide tartrate compound that holds FDA Breakthrough Therapy Designation for generalized anxiety disorder.

"With our first Phase 3 MDD trial, Emerge, now fully enrolled and advancing toward topline data, and our Phase 3 GAD studies rapidly progressing, 2026 represents a monumental year for Definium," said Rob Barrow, CEO of Definium Therapeutics.

The Emerge study in major depressive disorder is fully enrolled with topline data expected in late Q2 2026. The Voyage and Panorama trials in generalized anxiety disorder are advancing toward enrollment completion, and the company plans to start the Ascend study in major depressive disorder in early to mid-2026. Across the DT120 program, at least three Phase 3 readouts are anticipated in 2026. Definium also dosed the first patient in a Phase 2a study of DT402 (R(-)-MDMA) for autism spectrum disorder, with initial data expected this year. R&D expenses rose to $117.7 million for 2025, up from $65.3 million in 2024, driven by the DT120 program expansion across multiple indications.

GH Research (NASDAQ: GHRS) announced that the FDA lifted the clinical hold on its Investigational New Drug application for GH001, a mebufotenin (5-MeO-DMT) therapy for treatment-resistant depression, enabling U.S. patient enrollment and clearing the path for global Phase 3 initiation in 2026. The FDA had placed a clinical hold in 2023 due to insufficient risk assessment information; the company submitted a complete response in June 2025 after completing the required toxicology studies.

"This is a major milestone for GH001 as a potential ultra-rapid, durable treatment for treatment-resistant depression," said Dr. Velichka Valcheva, CEO of GH Research.

The company's Phase 2b trial demonstrated a placebo-adjusted MADRS reduction of -15.5 points at Day 8 (p<0.0001), with 57.5% of patients achieving remission at Day 8 and 73% at six months with approximately four treatments on average. GH001 features a short median psychoactive exposure of 11 minutes, requires no psychotherapy, and showed no serious treatment-related adverse events, with 99% of participants discharge-ready within one hour. The company plans to seek FDA alignment on a global Phase 3 program design replicating the Phase 2b trial protocol.

Article Source: https://usanewsgroup.com/2026/02/24/this-fda-breakthrough-depression-drug-just-hit-nature-medicine-wall-street-says-its-worth-22-share/

CONTACT:

USA NEWS GROUP

info@usanewsgroup.com

(604) 265-2873

DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for Helus Pharma advertising and digital media from Creative Digital Media Group ("CDMG"). There may be 3rd parties who may have shares of Helus Pharma, and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of Helus Pharma but reserve the right to buy and sell, and will buy and sell shares of Helus Pharma at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of Helus Pharma by CDMG; this is a paid advertisement, we currently own shares of Helus Pharma and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

SOURCES:

1. https://www.statnews.com/2026/02/17/compass-pathways-comp360-psilocybin-severe-depression-trial-results/
2. https://www.federalregister.gov/documents/2026/01/05/2025-24277/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessment
3. https://www.who.int/news/item/02-09-2025-over-a-billion-people-living-with-mental-health-conditions-services-require-urgent-scale-up
4. https://www.nimh.nih.gov/health/statistics/major-depression

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Issued on behalf of Helus Pharma

VANCOUVER, BC, Feb. 26, 2026 /PRNewswire/ -- USA News Group News Commentary – The first psilocybin compound to achieve two positive Phase 3 results in treatment-resistant depression cleared that milestone this week, signaling a potential shift in how regulators and investors view psychedelic-based psychiatry^[1]. The pathway is widening at the federal level, where the Drug Enforcement Administration raised its 2026 psilocybin production quota by 67%^[2]. Five companies are working to translate that momentum into approved treatments: Helus Pharma (NASDAQ: HELP), Compass Pathways (NASDAQ: CMPS), Relmada Therapeutics (NASDAQ: RLMD), Alto Neuroscience (NYSE: ANRO), and Axsome Therapeutics (NASDAQ: AXSM).

The World Health Organization estimates that depression and anxiety cost the global economy more than $1 trillion annually in lost productivity^[3]. The pipeline is moving to meet it, and the capital is following.

Helus Pharma (NASDAQ: HELP) is a clinical-stage pharmaceutical company developing treatments for depression and anxiety. Its approach centers on novel serotonergic agonists, synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity.

Originally founded as Cybin in 2019, the company rebranded to Helus Pharma in January 2026, pronounced "Heal-Us," and began trading on the NASDAQ under the ticker HELP. The name reflects its transition toward a commercial-ready pharmaceutical operation.

The company holds over 350 filed patents with more than 100 already granted, providing protection around its lead programs through at least 2041. It operates across Canada, the United States, the United Kingdom, and Ireland.

Recently, Nature Medicine published results from a randomized, placebo-controlled Phase 2a trial of SPL026 in patients with moderate-to-severe major depressive disorder. The study enrolled 34 participants across three clinical sites in the United Kingdom.

The study met its primary endpoint. Participants receiving a single 21.5 mg dose showed a mean MADRS difference of -7.35 versus placebo (p=0.023), with effects appearing within one week (p=0.002).

Response rates at two weeks reached 35% versus 12% for placebo. Remission rates were 29% versus 12%.

Effects were sustained for up to three months, with some participants maintaining improvements for up to six months. No treatment-related serious adverse events were reported.

"The findings provide clinical proof-of-concept for short-acting serotonergic modulation and further support our conviction that our novel serotonergic agonist molecules, such as HLP004, can potentially deliver meaningful outcomes with greater consistency and commercial feasibility," said Michael Cola, CEO of Helus Pharma.

HLP004, a proprietary intramuscular compound informed by the SPL026 clinical insights, is now in Phase 2 for generalized anxiety disorder. Helus expects topline data from that study this quarter.

The company's lead asset HLP003, a proprietary oral compound granted FDA Breakthrough Therapy Designation, is advancing through two pivotal Phase 3 studies for the adjunctive treatment of major depressive disorder.

Phase 2 data on HLP003 demonstrated 100% response rates and 71% remission at 12 months after just two 16 mg doses, with an approximately 23-point reduction in MADRS scores.

The APPROACH pivotal Phase 3 study has topline data anticipated in Q4 2026, while the complementary EMBRACE Phase 3 study and EXTEND long-term extension study continue to progress.

Helus reported US$195.1 million in cash as of December 31, 2025, supporting continued advancement across its multi-asset clinical pipeline.

CONTINUED… Read this and more news for Helus Pharma at:

https://usanewsgroup.com/2026/02/24/this-fda-breakthrough-depression-drug-just-hit-nature-medicine-wall-street-says-its-worth-22-share/ 

In other industry developments:

Compass Pathways (NASDAQ: CMPS) this week reported positive results from two pivotal Phase 3 trials evaluating COMP360, a synthetic psilocybin compound, in patients with treatment-resistant depression. The larger trial, COMP006, enrolled 581 participants across international sites and demonstrated a highly statistically significant reduction in symptom severity, with a p-value below 0.001 and a mean treatment difference of 3.8 points on the MADRS depression scale at Week 6.

The company has submitted a request to the FDA to discuss a rolling submission and review, a pathway that could shorten the timeline to a potential approval filing. Across both Phase 3 studies, 39% of participants receiving the 25 mg dose achieved a clinically meaningful reduction in depression scores at Week 6, with durable effects observed through 26 weeks after just one or two administrations.

COMP360 is the first classic psychedelic to achieve two highly statistically significant Phase 3 readouts in treatment-resistant depression, a condition that affects roughly one-third of patients who do not respond to standard antidepressants. Most treatment-emergent adverse events were mild or moderate, with the vast majority resolving within 24 hours. The company expects 26-week durability data from COMP006 in early Q3 2026.

Relmada Therapeutics (NASDAQ: RLMD) in January confirmed that the FDA has aligned on the registrational development pathway for NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer. The agency indicated that a single-arm, open-label pivotal trial is appropriate for second-line refractory high-grade patients with carcinoma in situ, one of the most treatment-resistant bladder cancer populations.

"A single-arm pivotal study in this setting represents a meaningful opportunity to advance an in-office, bladder-sparing therapy for patients who have few if any effective alternatives," said Raj S. Pruthi, MD, Chief Medical Officer at Relmada Therapeutics. "This study represents the fastest path to approval for NDV-01."

The company anticipates initiating both registrational trials in the first half of 2026. NDV-01 is designed to be administered in-office in under five minutes without anesthesia or specialized equipment, with bladder retention and gradual drug release over ten days. Non-muscle invasive bladder cancer represents 75% to 80% of all bladder cancer cases, with over 744,000 prevalent cases in the United States and recurrence rates of 50% to 80% over five years.

Alto Neuroscience (NYSE: ANRO) recently completed enrollment in its Phase 2 proof-of-concept trial of ALTO-101, a novel transdermal PDE4 inhibitor for cognitive impairment associated with schizophrenia. The randomized, double-blind, placebo-controlled crossover study enrolled 83 patients across 13 clinical sites in the United States, with topline data expected around the end of Q1 2026.

"This milestone brings us closer to potentially delivering a first-of-its-kind treatment for the millions of patients suffering from the debilitating cognitive effects of schizophrenia," said Amit Etkin, MD, PhD, founder and CEO of Alto Neuroscience. "Our baseline results have already replicated findings from three independent datasets, reinforcing our confidence in ALTO-101's mechanism and our biomarker-driven approach."

There are currently no approved pharmacologic treatments for cognitive impairment in schizophrenia, a condition affecting nearly all patients with the disorder and a primary driver of long-term functional disability. ALTO-101 is delivered through a proprietary transdermal system developed with MEDRx, designed to reduce the gastrointestinal side effects common to oral PDE4 inhibitors while maintaining central nervous system target engagement. The FDA has granted ALTO-101 Fast Track Designation for this indication.

Axsome Therapeutics (NASDAQ: AXSM) in December announced that the FDA has accepted and granted Priority Review to its supplemental New Drug Application for AXS-05, a novel NMDA receptor antagonist and sigma-1 agonist, for the treatment of Alzheimer's disease agitation. The PDUFA target action date is April 30, 2026.

"Up to 76% of people with Alzheimer's disease experience agitation, representing a significant unmet medical need for patients and their caregivers, and currently there is a dearth of approved treatments," said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. "We look forward to continuing to work with the FDA for the remainder of the review."

AXS-05 previously received FDA Breakthrough Therapy designation for Alzheimer's agitation in 2020 and is already approved in the United States as Auvelity for the treatment of major depressive disorder in adults. The supplemental NDA is supported by four randomized, double-blind, controlled Phase 3 trials and a long-term safety study. Approximately 7 million Americans live with Alzheimer's disease, and the company's patent estate for AXS-05 extends through at least 2043.

Article Source: https://usanewsgroup.com/2026/02/24/this-fda-breakthrough-depression-drug-just-hit-nature-medicine-wall-street-says-its-worth-22-share/ 

CONTACT:

USA NEWS GROUP

info@usanewsgroup.com

(604) 265-2873

DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for Helus Pharma advertising and digital media from Creative Digital Media Group ("CDMG"). There may be 3rd parties who may have shares of Helus Pharma, and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY does not own any shares of Helus Pharma but reserve the right to buy and sell, and will buy and sell shares of Helus Pharma at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved on behalf of Helus Pharma by CDMG; this is a paid advertisement, we currently own shares of Helus Pharma and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.

SOURCES:

1. https://www.statnews.com/2026/02/17/compass-pathways-comp360-psilocybin-severe-depression-trial-results/
2. https://www.federalregister.gov/documents/2026/01/05/2025-24277/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessment
3. https://www.who.int/news/item/02-09-2025-over-a-billion-people-living-with-mental-health-conditions-services-require-urgent-scale-up

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