GH Research PLC（GHRS）资讯与事件GHRSGH Research PLC

Compass Pathways Q2 Loss Widens to 34 Cents

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on earnings, a DSMB approval and a CEO appointment.EARNINGS:On Thursday, GH Researchreportedwhich compared to analyst estimates of a loss per share of (30c). Cash, cash equivalents and marketable securities were $362.7M as of June 30, compared to $280.7M as of December 31, 2025. The company said, "We have completed GH001-HV-106, our Phase 1 clinical pharmacology trial of our proprietary aerosol delivery device in healthy volunteers, and GH001-HV-109, our IND-opening Phase 1 trial of GH001 in healthy volunteers in the United States. Based on the results of GH001-HV-106, we have selected the doses for our pivotal program. In July 2026, we received written responses from the FDA confirming that our CMC and device plans appear Phase 3 ready. We continue to engage with the FDA on the design of the pivotal program, which is intended to replicate the Phase 2b trial, including consideration of recent FDA guidance issued in July 2026, and we continue to target initiation of our pivotal program in 2026."On Wednesday, Compass Pathwaysreportedwhich compared to analyst estimates of a loss per share of (34c). The increase in net loss was primarily driven by non-cash fair value adjustments related to warrants. Cash and cash equivalents were $433.3M as of June 30, compared with $149.6M as of December 31, 2025. The current cash position is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2028. "The first half of 2026 marked a defining period for Compass as we continued to build momentum across clinical, regulatory and commercial fronts in preparation for the potential approval and launch of COMP360," said Kabir Nath, CEO. "Over the past six months, we have strengthened – and further validated – the consistent evidence supporting COMP360's transformative potential, expanded our commercial readiness capabilities, deepened engagement across the treatment ecosystem, and advanced our rolling submission in support of a regulatory filing in Q4. Our focus now is on disciplined execution - completing our filing activities and ensuring we are ready to deliver COMP360 to patients with TRD as quickly as possible, if approved. Our conviction in the potential of COMP360 has never been stronger. We are well positioned, confident in our ability to execute, and committed to bringing this transformative new treatment option to patients."Compass also announced Thursday it is working with the U.S. Department of Verterans Affairs on a multi-site randomized controlled clinical trial. The study will evaluate the safety and efficacy of COMP360 psilocybin in the treatment of treatment-resistant depression in veterans, including those with concurrent post-traumatic stress disorder. The trial, titled "Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression," or PIVOT, reflects VA's commitment to pursuing innovative solutions for veterans who have not responded to existing treatments. Compass will donate the study drug - COMP360, a synthetic, proprietary pharmaceutical-grade formulation of psilocybin optimized for stability and purity. Compass will support the education and training of the investigators and their training team through the provision of training materials, guidance, and consultation on administration protocols. In turn, the investigators and their training team will train the initial cohort of health care providers and will be prepared to train additional support providers as needed.The multi-site, double-blind, randomized controlled trial will enroll veterans diagnosed with TRD, with or without concurrent PTSD, and will compare outcomes between two different doses of COMP360 psilocybin with the option for a second open label administration four weeks after initial dose. The primary measure of efficacy will be depression severity, assessed using the Montgomery-Asberg Depression Rating Scale. Secondary outcomes will include assessments of PTSD symptom severity, tolerability of side effects, and overall patient-reported depression. The lead site is the Birmingham VA Health Care System in Alabama, in collaboration with four additional VA sites in Tuscaloosa, Portland, Seattle and Philadelphia.RBC Capital lowered the firm's price target on Compass to $21 from $22 and kept an Outperform rating on the shares. Compass Pathways reported a solid quarter with progress toward a Q4 TRD filing and potential 2027 launch, supported by strong patient, prescriber, and payer interest, while PTSD optionality and attractive valuation enhance long-term upside potential, the analyst said.B. Riley raised the firm's price target on Compass to $22 from $17 and kept a Buy rating on the shares post the Q2 report. The company disclosed that the FDA has begun reviewing COMP360 data modules submitted under the rolling new drug application, the analyst said.CLEARMIND SAYS DSMB CLEARS AUD STUDY PROGRESSION:Clearmind Medicineannounced Thursday that its independent Data and Safety Monitoring Board has unanimouslyto parts B and C, evaluating CMND-100 in patients actively suffering from Alcohol Use Disorder and in healthy participants, respectively. The DSMB's approval follows the completion of Part A of the study, where CMND-100 achieved its primary safety endpoint, demonstrating a favorable safety and tolerability profile across all planned dose levels in healthy participants. After reviewing the full safety dataset from Part A, the DSMB unanimously recommended advancing the study to Parts B and C in accordance with the previously approved study protocol. Part B marks a clinical milestone for Clearmind, as CMND100 will be evaluated for the first time in human patients with moderate to severe AUD, unlike Part A that included only healthy participants. This phase will enroll, sequentially, two cohorts of six patients receiving 80 mg and 160 mg doses, respectively, and will assess safety, tolerability, and early signals of clinical activity, including CMND100's potential to reduce alcohol consumption and craving. Part C will be conducted, concurrently with Part B, in healthy participants and will evaluate CMND‑100 at a fixed daily dose of 160 mg administered over five consecutive days. This double‑blind, placebo-controlled segment will further characterize the safety and tolerability profile of CMND‑100."Receiving DSMB approval to advance our clinical trial to patients with AUD marks an important milestone for Clearmind," said Adi Zuloff-Shani, CEO. "With the successful demonstration of safety and tolerability throughout the dose-escalation phase of the study, we are now positioned to evaluate CMND-100 in the population it is designated to help. This transition represents a meaningful step toward advancing a potential new treatment option for individuals living with AUD."Clearmind also announced Monday that it has entered into a non-binding Letter of Intent  to acquire 51% stake in electric vehicles wireless charging solutions for automated parking systems and autonomous mobile platforms company.  Under the terms of the LOI, Clearmind will acquire the majority stake of the company for an aggregate purchase price of $2.5M. In addition, in connection with and as a condition to the closing of the acquisition, the company shall extend a loan to the acquired company in the principal amount of $1.5M. The loan shall bear interest at a rate of 4% per annum and shall be repaid on the two year anniversary of the closing.HELUS APPOINTS NEW CEO:Helus Pharmaannounced Monday the. Halstead's appointment comes as Helus advances HLP003 through late-stage clinical development and prepares for potential commercialization. Enrollment is complete in APPROACH, with topline data expected in Q4, while enrollment continues in EMBRACE, the second pivotal study in the Phase 3 PARADIGM program. Participant rollover is ongoing into EXTEND, the long-term extension study. Halstead brings 25 years of industry experience, most recently serving as President of Intra-Cellular Therapies."Mr. Halstead's leadership and operational experience guiding pharmaceutical companies through late-stage development, infrastructure buildout, and commercialization will be invaluable as we execute against our upcoming HLP003 and HLP004 clinical, regulatory, and commercial milestones," said Eric So, Executive Chairman.ENVERIC REPORTS EB-003 PRECLINICAL DATA:Enveric Biosciencesannounced Wednesday new preclinical data that further supports the growing body of evidence reinforcing thePreclinical testing of EB-003 was conducted using a targeted  GloSensor cAMP assay. The Promega GloSensor cAMP assay is a highly sensitive live-cell test designed to detect subtle Gi-coupled receptor responses in real time. The study evaluated EB-003 alongside known hallucinogenic and non-hallucinogenic reference compounds and produced results that the company believes are consistent with recently published Nature research, which identified signaling characteristics that distinguish compounds predicted to be hallucinogenic from those expected to be non-hallucinogenic in humans. The 2026 Nature paper linked 5-HT2A receptor-mediated Gi activation with hallucinogenic compounds, suggesting that the strength of this signaling response may help predict whether a drug will be hallucinogenic in humans. In Enveric's study evaluations, EB-003 consistently fell within the non-hallucinogenic range."These new findings further support our previous studies regarding the differentiated design of EB-003 and its non-hallucinogenic profile," said Joseph Tucker, CEO. "The consistency of the data across multiple independent assay platforms provides important validation of our approach as we prepare to advance EB-003 into Phase 1 clinical development. As the FDA continues to define the regulatory framework for psychedelic-inspired therapies, we believe compounds designed to preserve the therapeutic potential of neuroplasticity without requiring a hallucinogenic experience could offer meaningful advantages in clinical development while supporting broader patient access and potential commercial adoption."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, AtaiBeckley, BetterLife, Bright Minds, Definium Therapeutics, Filament Health, Incannex, MIRA Pharmaceuticals, NRx Pharmaceuticals, Numinus Wellness, Optimi Health, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Revive Therapeutics, Sibannacand Silo Pharma.

Company Completes GH001 Clinical Trials, Plans Pivotal Program Launch in 2026

The company said, "We have completed GH001-HV-106, our Phase 1 clinical pharmacology trial of our proprietary aerosol delivery device in healthy volunteers, and GH001-HV-109, our IND-opening Phase 1 trial of GH001 in healthy volunteers in the United States. Based on the results of GH001-HV-106, we have selected the doses for our pivotal program. In July 2026, we received written responses from the FDA confirming that our CMC and device plans appear Phase 3 ready. We continue to engage with the FDA on the design of the pivotal program, which is intended to replicate the Phase 2b trial, including consideration of recent FDA guidance issued in July 2026, and we continue to target initiation of our pivotal program in 2026."

PharmAla Enters $100M License Agreement with Jupiter

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on a license agreement, enrollment completion and a patent filing.PHARMALA, JUPITER ENTER LICENSE AGREEMENT:PharmAla Biotech Holdingsannounced Tuesday that it haswith Jupiter Neurosciencesunder which PharmAla has granted Jupiter an exclusive, perpetual, royalty-bearing license to develop, manufacture and commercialize ALA-002, PharmAla's lead drug candidate, in the United States. PharmAla retains all rights to ALA-002 outside the U.S. and will continue to advance the molecule internationally. Under the agreement, the total consideration payable to PharmAla is up to approximately $100M, consisting of a $3,333,333 upfront payment and up to $96,666,666 in contingent development, regulatory and commercialization milestone payments, plus royalties on all future U.S. net sales following the conclusion of milestone payments. The milestone payments and royalties are contingent on the achievement of specified development, regulatory and sales events, which may not be achieved."This Agreement is a landmark transaction for PharmAla and its shareholders. It delivers near-term capital, meaningful milestone and royalty participation, and a dedicated U.S. development partner in Jupiter, all while PharmAla retains full ownership of ALA-002 outside the United States," said Nick Kadysh, CEO, PharmAla. "We developed ALA-002 to deliver an improved MDMA-based therapeutic candidate for patients who need better treatment options across a range of neuropsychiatric disorders. Jupiter's focus on central nervous system disorders and its commitment to advancing innovative brain therapies in the United States make this a strong strategic fit, and allow us to concentrate our own resources on advancing ALA-002 and our broader MDXX pipeline in the rest of the world."HELUS COMPLETES APPROACH STUDY ENROLLMENT:Helus Pharmaannounced Tuesday that it hasof HLP003 in patients living with Major Depressive Disorder. APPROACH enrolled adults with moderate to severe MDD, who experience inadequate response despite a stable antidepressant regimen. Completion of enrollment represents an important milestone for Helus Pharma and advances the company toward the expected release of topline data in Q4. The APPROACH study, and broader PARADIGM Program, incorporate key considerations outlined in the FDA's recently finalized guidance. Enrollment is continuing in EMBRACE, the second pivotal study in the Phase 3 PARADIGM Program. Eligible participants from APPROACH and EMBRACE may also roll over into EXTEND, Helus Pharma's long-term extension study, which is designed to further evaluate safety, durability of clinical effect and the potential role of redosing."Completion of enrollment in APPROACH ahead of schedule demonstrates the focus and execution of our clinical team, investigators and study partners. We thank them and the trial participants for achieving this important milestone. We believe the pace of enrollment of participants reflects not only the efficiency of our clinical team, but also the strength of our screening and site selection processes. Despite rigorous eligibility requirements, we successfully enrolled participants with baseline disease severity aligned with that of our Phase 2 study, reinforcing the quality and integrity of the Phase 3 study population," said Eric So, Interim CEO. "With participant enrollment now complete, our focus turns to completing the study and preparing for topline data in Q4 2026. We believe the durability, remission rates, and overall profile demonstrated in our Phase 2 study support the potential of HLP003 to meaningfully improve outcomes for patients living with MDD, and we look forward to advancing the program through the next stage of development and toward a potential FDA New Drug Application in 2028."Guggenheim lowered the firm's price target on Helus Pharma to $45 from $48 and kept a Buy rating on the shares. The Eli Lillytransaction for AtaiBeckleyvalidates the short-acting psychedelic thesis for pharma and "confirms that this class is now firmly on their strategic radars," said the analyst, who argued that Helus and GH Research"should be on investor radars."CLEARMIND REPORTS HONG KONG PATENT FILING:Clearmind Medicineannounced Monday the filing of afor psychedelic compounds targeting the treatment of Post-Traumatic Stress Disorder and other mental health disorders. The Hong Kong patent application forms part of Clearmind's exclusive worldwide licensing agreement with Yissum Research Development Company of the Hebrew University of Jerusalem. Under the terms of the licensing agreement, Clearmind holds exclusive global rights to develop, manufacture, and commercialize novel compounds developed at Yissum. Clearmind is responsible for advancing the development program in accordance with regulatory requirements.Additionally on Friday, the company noted the significant regulatory and inter-agency developments supporting the development of innovative treatments for serious neuropsychiatric and addiction disorders. This developments include final FDA guidance on psychedelic clinical investigations, a planned public hearing on the therapeutic use of psychedelics, and new Memoranda of Understanding and collaborative initiatives involving the U.S. Department of Health and Human Services, Department of Veterans Affairs, FDA, National Institute on Drug Abuse, ARPA-H, and Health Resources and Services Administration.Adi Zuloff-Shani, CEO, stated, "At a time when patients in the veterans community and the general population have too few treatment options for intractable neuropsychiatric and addiction disorders, we are grateful that Secretary Kennedy is looking to transform treatment opportunities through the expansion of new therapeutic approaches."NRX SAYS DARPA SELECTS PROPOSAL FOR NEGOTIATION:In April, NRx Pharmaceuticalsannounced the incorporation of NRx Defense Systems, a Florida-based research and development subsidiary charged with the development of neuroplastic treatments that combine D-cycloserine with Transcranial Magnetic Stimulation under robotic-enabled neuro-navigation. The company anticipated NRXD participating in future government and non-governmental research and development, based on Phase I and II research conducted by the company's Chief Medical Innovation Officer. On July 21, NRXDDefense Sciences Office, notifying the company that its proposal to conduct a clinical trial, entitled Synaptic Plasticity Augmented Rapid Circuit Stimulation had been selected by DARPA for negotiation of a potential award. The protocol for the SPARC-TMS trial was approved as a phase 2/3 trial by the FDA. The trial aims to demonstrate the potential efficacy of robotic-enabled TMS combined with NRX-101 in achieving remission from depression. The study is planned to be conducted at Harvard Mclean hospital, at clinics operated by HOPE Therapeutics, and at designated military treatment facilities including the Walter Reed National Military Medical Center.ATAIBECKLEY DOWNGRADES:TD Cowen downgraded AtaiBeckleyafter Eli Lilly agreed to acquire the company for $6.75 per share upfront cash plus up to $2.50 per share in contingent payments.Berenberg downgraded AtaiBeckley to Hold from Buy with a $7.45 price target.Additionally, H.C. Wainwright downgraded AtaiBeckley to Neutral from Buy with a price target of $7.50, down from $25. The transaction delivers AtaiBeckley shareholders near-term certainty and transfers substantial execution risk, the analyst said.OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Bright Minds, Compass Pathways, Definium Therapeutics, Enveric Biosciences, Filament Health, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Optimi Health, Pasithea Therapeutics, PharmaTher, Psyence Biomedical, Psyence Group, Revive Therapeutics, Sibannacand Silo Pharma.