Enveric Biosciences Inc（ENVB）資訊與事件ENVBEnveric Biosciences Inc

TD Cowen Raises Helus Price Target to $62

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on earnings, analyst notes and a notice of allowance.EARNINGS:On Monday, Bright Minds Biosciencesreported a third quarter loss per share of (C$0.24), which compared to a loss per share of (C$0.74) for the same period last year. At June 30, the company had working capital of C$307,739,740 including cash and cash equivalents of C$307,828,515. The company's current and expected cash resources are sufficient to satisfy working capital requirements of running the operations for the following twelve months; however, the company has not realized a source of revenue therefore, management will continue to seek new sources of capital to maintain its operations.Also on Monday, NRx Pharmaceuticalsreported a Q2 loss per share of (44c), which compared to a loss per share of (98c) for the same period last year. As of June 30, the company had approximately $26.7M in cash and cash equivalents versus $7.8M as of December 31, 2025. The increase was primarily related to the company's completion of a public offering of common stock with gross proceeds of more than $22M. Management believes current cash resources, anticipated growth in clinic revenue, and opportunistic utilization of the company's active at-the-market offering facility will be sufficient to support operations for at least one year. "The second quarter of 2026 was a major inflection point for NRx as we advance our mission to bring hope to the most vulnerable patients battling depression and suicidal ideation," said Jonathan Javitt, CEO. "We have continued to drive towards our key objective of first commercial ketamine sales in 2026 with corresponding manufacturing operations and build-out of our first commercial team. Our path to approval of NRX-100 has been advanced by support from the White House and Congress for the use of Real World Evidence that our drug has comparable or superior efficacy to that of current market leaders. Our partnership with the Department of War and its Defense Advanced Research Projects Agency led by Prof. Brown and Dr. Dennis McBride is the culmination of a multi-year endeavor. Similarly, our acquisition of the GeNeuro assets and the resulting partnership with NIH offers a clinical stage and potentially humanity-changing opportunity for the Company – including potentially the first disease-modifying drug to treat ALS – in ALS and other serious disorders, with strong governmental partnership and support from non-dilutive sources of capital. Combat veterans face a two-fold increased risk of ALS, and advancing a cure remains a high priority with strong Congressional support."On Friday, Enveric Biosciencesreported a Q2 loss per share of (76c), which compared to a loss per share of ($11.65) last year. The company had cash-on-hand of $8.3M as of June 30. "The second quarter was highlighted by important progress across the key activities supporting our planned first-in-human clinical trial of EB-003," said Joseph Tucker, CEO. "Over the past several months, we advanced multiple IND-enabling studies and generated additional preclinical data that support EB-003's potential non-hallucinogenic profile. Collectively, these accomplishments strengthen the scientific foundation of our lead program as we work toward an IND submission for the anticipated Phase 1 trial…As we enter the second half of 2026, our priorities remain clear: complete the remaining IND-enabling activities, submit our planned IND application, and advance EB-003 into a first-in-human clinical trial. We believe the progress over the past several months has strengthened both our lead development program and the broader Enveric platform, positioning the Company to continue creating long-term strategic and shareholder value."Helus Pharmaalso reported earnings Friday, with a Q1 loss per share of (91c), which compared to loss per share of ($1.10) for the same period last year. Cash totaled $166.4M as of June 30. "Since joining Helus Pharma, I have been impressed by the quality of the Company's science, the strength of its development programs, and the team's disciplined execution," said Michael Halstead, CEO. "With enrollment in APPROACH completed and topline data expected in Q4 2026, we are entering an important period for HLP003. We are also advancing HLP004 as a promising short-acting candidate for generalized anxiety disorder and remain focused on executing our clinical, regulatory and commercial priorities in support of our mission to deliver transformative treatment options for patients."TD Cowen raised the firm's price target on Helus to $62 from $8 and kept a Buy rating on the shares. The firm said its target increase is due to three major recent value-creating tailwinds to their thesis. The increased visibility into Phase 3 HLP003 adjunct MDD data timing, now expected mid-November, a new, seasoned CEO with an extensive operational and strategic track record in neuropsych, and new M&A, regulatory and executive branch tailwinds for the psychedelic neuropsych sector.DEFINIUM INITIATED WITH A BUY:BofA initiated coverage of Definium Therapeuticswith a Buy rating and $75 price target. The company's lead asset, DT120 – LSD, is in pivotal studies for major depressive disorder and generalized anxiety disorder with recent best-in-class potential demonstrated in the phase 3 studies for both indications, the analyst said. If replicated in ongoing pivotal studies, the firm believes that DT120 could be a go-to option for patients with severe MDD and GAD, representing multi-billion dollar commercial opportunities, BofA added.Maxim raised the firm's price target on Definium to $55 from $50 and kept a Buy rating on the shares. The firm cited the company having announced topline data from Voyage, its first pivotal study in GAD, meeting the primary and all key secondary endpoints, also noting that data from the confirmatory pivotal study, Panorama, are expected in September, the analyst said.ATAIBECKLEY DOWNGRADE:Oppenheimer downgraded AtaiBeckleyto Perform from Outperform without a price target after Eli Lillyagreed to acquire the company for $6.75 per share upfront cash plus up to $2.50 per share in contingent payments.SILO PHARMA RECEIVES NOTICE OF ALLOWANCE:Silo Pharmaannounced Tuesday that the Canadian Intellectual Property Office has issued a Notice of Allowance for a patent application covering its lead asset, SPC-15, an intranasal 5-HT4 receptor agonist targeting post-traumatic stress disorder and other stress-induced psychiatric disorders. The company has an exclusive license for the Canadian patent application as part of its broader license agreement with Columbia University to further develop, manufacture, and commercialize SPC-15 globally. The allowed patent application, titled "Prophylactic Efficacy of Serotonin 4 Receptor Agonists Against Stress," covers methods of preventing or delaying stress-induced fear and depressive-like behavior and methods for inducing and/or enhancing stress resilience by administering selected serotonin 4 receptor agonists prior to a stressor."The Canadian patent allowance adds to our momentum in securing broad international protection for SPC-15," said Eric Weisblum, CEO. "With corresponding claims receiving protection across multiple markets, we continue to strengthen the global IP position of SPC-15 and our broader therapeutic portfolio."OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, BetterLife, Clearmind, Compass Pathways, Filament Health, GH Research, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Optimi Health, Pasithea Therapeutics, PharmAla Biotech, PharmaTher, Psyence Biomedical, Revive Therapeutics, Sibannacand Silo Pharma.

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.

Enveric Biosciences Welcomes FDA's Guidance on Psychedelic Clinical Trials

Enveric Biosciences welcomed the U.S. Food and Drug Administration's recent release of finalized guidance for clinical investigations of psychedelic and psychedelic-inspired therapeutics. "The final guidance reflects the FDA's continued engagement with clinical development issues in this field and underscores the importance of generating data that can support rigorous regulatory review," said Joseph Tucker, Ph.D., CEO. "The agency is not lowering the standard. It is giving developers a clearer view of the issues that must be solved, including functional unblinding, patient monitoring, abuse potential, repeat dosing, and the role of psychotherapy. Those are exactly the types of issues that informed how we designed EB-003." Although the guidance primarily addresses drugs that produce acute psychedelic effects, Enveric believes many of the other concerns identified by FDA also illustrate the potential advantages of Enveric's approach. The FDA notes that obvious perceptual effects may compromise clinical trial blinding, accompanying psychotherapy can make it difficult to determine the contribution of the drug itself, and patients receiving hallucinogenic drugs may require prolonged observation by specially trained monitors. The pharmacological properties of EB-003 have the potential to mitigate these concerns. "Many of the hardest development and commercial problems in this field are not necessarily created by the therapeutic target," Dr. Tucker continued. "They are created by the hallucinogenic experience. That experience can make blinding difficult, require hours of supervision, confound the effects of the drug with those of psychotherapy, and create questions around abuse potential. If clinical studies confirm the non-hallucinogenic profile observed in preclinical models, we believe EB-003 clinical development will be less challenging and yield more clear data readouts, and a more practical treatment model."