AtaiBeckley Inc.

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.

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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/

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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. 27, 2026 /PRNewswire/ -- Equity-Insider.com News Commentary — Psychedelic compounds are edging closer to regulatory approval as pivotal trials in treatment-resistant depression and anxiety advance through late-stage development^[1]. The sector is shedding its countercultural reputation as biotech firms reposition serotonergic and psychedelic-derived therapies as mainstream pharmaceutical candidates^[2]. Five companies are building the clinical programs to get there: Helus Pharma (NASDAQ: HELP), AtaiBeckley (NASDAQ: ATAI), Definium Therapeutics (NASDAQ: DFTX), GH Research (NASDAQ: GHRS), and LB Pharmaceuticals (NASDAQ: LBRX).

A consensus statement from the U.S. National Network of Depression Centers published in The Lancet outlined considerations for integrating psychedelic into routine clinical practice, a signal that academic medicine is preparing for what the trials may deliver^[3]. The clinical infrastructure is expanding, and the investment thesis 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:

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In other industry developments:

AtaiBeckley (NASDAQ: ATAI) in January outlined its 2026 pipeline strategy ahead of the J.P. Morgan Healthcare Conference, reporting that its lead candidate BPL-003, a mebufotenin benzoate nasal spray for treatment-resistant depression, met its primary and all key secondary endpoints in Phase 2b. The company expects Phase 3 guidance in the first quarter and trial initiation by mid-year, with financial resources supporting operations into 2029.

"Following the strategic combination of atai Life Sciences and Beckley Psytech completed last year and the recent corporate redomiciliation to the United States, we enter 2026 with meaningful momentum and a clear vision for the impact AtaiBeckley can deliver for people living with difficult-to-treat mental health conditions," said Dr. Srinivas Rao, Co-Founder and CEO of AtaiBeckley.

The company's broader pipeline includes VLS-01, a DMT buccal film for treatment-resistant depression with Phase 2 data expected in the second half of 2026, and EMP-01, an oral R-MDMA compound for social anxiety disorder with Phase 2a results anticipated this quarter. AtaiBeckley was added to the NASDAQ Biotechnology Index in December following its formation through the merger of atai Life Sciences and Beckley Psytech. A new patent granted in December covering its R-MDMA compound extends exclusivity through 2043.

Definium Therapeutics (NASDAQ: DFTX) in January completed its rebrand from MindMed, signaling its transition from a psychedelic research platform to a late-stage psychiatry company. Its lead candidate DT120, an LSD-derived orally disintegrating tablet with FDA Breakthrough Therapy Designation for generalized anxiety disorder, has three Phase 3 readouts expected in 2026. The company also dosed its first patient in a Phase 2a study of DT402 in autism spectrum disorder.

"We are unwavering in our mission to forge a new era of psychiatry by applying scientific rigor to psychedelics," said Rob Barrow, CEO of Definium Therapeutics. "With three Phase 3 readouts expected in 2026, we are uniquely positioned to validate the strength of our science, advance care for patients, and continue delivering long-term value for our shareholders."

The three trials include Voyage for generalized anxiety disorder in the second quarter, Emerge for major depressive disorder at mid-year, and Panorama for generalized anxiety disorder in the second half. A fourth Phase 3, Ascend, targeting major depressive disorder, is planned for mid-year initiation. Generalized anxiety disorder and major depressive disorder together affect over 50 million people in the United States. The ticker changed from MNMD to DFTX effective January 13.

GH Research (NASDAQ: GHRS) in January announced that the FDA lifted the clinical hold on GH001, its proprietary inhaled mebufotenin (5-MeO-DMT) formulation for treatment-resistant depression, clearing the path for U.S. subject enrollment. The compound's Phase 2b trial met its primary endpoint with a 15.5-point placebo-adjusted MADRS reduction on Day 8 (p<0.0001). The hold had paused U.S. enrollment while the company continued advancing its European clinical program.

"The FDA clearance is a major milestone and positions us to advance GH001 as a potential ultra-rapid and durable treatment option for TRD patients," said Dr. Velichka Valcheva, CEO of GH Research. "We continue to expect initiation of our global pivotal program in 2026."

The global Phase 3 program is expected to replicate the Phase 2b design, targeting initiation in 2026. GH001 is administered via proprietary inhalation in a clinical setting, with sessions lasting under an hour. The Dublin-based company's approach to treatment-resistant depression differs from oral psychedelic programs in that it targets 5-HT receptor subtypes through a rapid-onset delivery mechanism. The company has positioned GH001 as a potential practice-changing option for the roughly one-third of depression patients who do not respond to standard antidepressants.

LB Pharmaceuticals (NASDAQ: LBRX) in January initiated its Phase 2 ILLUMINATE-1 trial of LB-102 in bipolar depression, enrolling approximately 320 patients across 30 U.S. sites. LB-102 is a novel once-daily oral benzamide antipsychotic targeting D2, D3, and 5-HT7 receptors, with Phase 2 schizophrenia data showing statistically significant benefit at all doses studied.

"The initiation of this Phase 2 trial in patients with bipolar depression marks an important step in our strategy to expand the potential of LB-102 for the treatment of mood disorders," said Heather Turner, CEO of LB Pharmaceuticals. "We look forward to a number of late-stage clinical catalysts, including results from this Phase 2 trial in the first quarter of 2028, as well as from our planned Phase 3 trial in schizophrenia which remains on track to initiate this quarter."

The company closed a $100 million private placement in February, with participation from institutional investors including Balyasny, Deep Track, and Nantahala. LB-102 could become the first benzamide antipsychotic approved in the United States, addressing a market of approximately 7 million bipolar patients domestically and 40 million worldwide. Phase 2 data in schizophrenia showed low rates of extrapyramidal symptoms and minimal sedation, differentiating LB-102 from existing antipsychotics.

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

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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 Equity-Insider 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.nature.com/articles/d41591-025-00062-4
2. https://www.bloomberg.com/news/articles/2025-12-26/psilocybin-aims-for-mainstream-as-a-psychedelic-treatment-for-depression
3. https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00450-X/fulltext

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