Enveric Biosciences Reports Q1 Earnings with Cash Balance of Approximately $10.3M
In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on earnings, the signing of a term sheet and a research agreement .PSYCHEDELIC EARNINGS:On Friday, Enveric Biosciencesreported awhich compared to a loss per share of ($14.58) for the same period last year. As of May 15, the company's cash balance was approximately $10.3M. Enveric believes these funds will support the completion of preclinical development activities for EB-003, the planned filing of an IND application, and operations into 1Q27. "Our progress in the first quarter of 2026 reflects continued execution against our core mission of developing therapeutics capable of addressing the significant unmet need in mental health," said Joseph Tucker, CEO. "We remain laser focused on advancing EB-003, Enveric's lead drug candidate in development, toward an IND submission and first-in-human clinical trials…With IND-enabling activities underway and a strong intellectual property position, we believe Enveric is well positioned to generate meaningful value for stockholders as we transition toward the clinical phase of drug development."Additionally on Tuesday, Enveric announced results from preclinical in vitro experiments evaluating the risk for phototoxicity, which indicated no photoreactive potential for EB-003, further derisking its continued development for the chronic treatment of neuropsychiatric disorders. This represents another preclinical safety assessment milestone for Enveric's neuroplastogen EB-003, a compound designed to selectively engage both 5-HT2A and 5-HT1B receptors. EB-003 is intended to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience. Phototoxicity testing is mandated by regulatory agencies like the FDA under the ICH S10 guideline and is performed to evaluate whether a novel pharmaceutical compound could become harmful when exposed to UV light.On Monday, NRx Pharmaceuticalsreportedwhich compares to a loss per share of (34c) for the same period last year. As of March 31, the company had approximately $6.7M in cash and cash equivalents. Management believes current cash resources, anticipated growth in clinic revenue, ongoing cost reduction initiatives, and continued availability under the company's active at-the-market offering will be sufficient to support operations through 2026. "The first quarter of 2026 was a pivotal one for NRx, as we advanced two lifesaving drugs towards FDA approval with the aim of initiating commercial pharmaceutical operations by the end of this year. We started the year debt-free, and made targeted investments in several critical strategic operating initiatives that drove substantial progress toward the approval of our first drug product, initiated commercial manufacture in anticipation of drug launch, advanced profitable clinic operations with an expanded footprint, burgeoned our overall intellectual property portfolio, augmented our development pipeline and attracted fundamental long-term investors who believe in our mission," said CEO Jonathan Javitt. "We are deeply grateful for the trust that has been afforded to us by our patients, their families, and our shareholders."On Thursday, Bright Minds Biosciencesreported awhich compared to a loss per share of (C$0.42) for the same period last year. At March 31, 2026, the company had working capital of C$308.5M including cash and cash equivalents of C$309.7M. The company's current and expected cash resources are sufficient to satisfy working capital requirements of running the operations for the following twelve months. Piper Sandler raised the firm's price target on Bright Minds to $220 from $190 and kept an Overweight rating on the shares. The firm caught up with Bright Minds following earnings, where management reflected confidence in the progress made across programs this past quarter. Piper remains bullish on Bright Minds and expects the stock will continue trading-up throughout the year, driving share-gains.PHARMALA, JUPITER SIGN TERM SHEET FOR ALA-002 U.S. RIGHTS:PharmAla Biotech Holdingsannounced Wednesday that it has entered into a term sheet under which PharmAla would grant Jupiter Neurosciencesexclusive,PharmAla's lead drug candidate and a next-generation, non-racemic MDMA novel chemical entity. The total potential value of the proposed transaction is in excess of $100M through a combination of upfront consideration, development milestone payments, and single-digit royalties on net sales. PharmAla would retain all rights to ALA-002 in territories outside of the U.S., including its existing commercial presence through its Cortexa joint venture in Australia. Pursuant to the term sheet, PharmAla would receive upfront consideration of $3.33M at closing of the definitive agreement, comprised of $1.50M in cash and $1.83M in shares of Jupiter common stock, with such shares subject to a 10-day lock-up period. The term sheet additionally provides that further development milestone payments and royalties will be paid to PharmAla as the product is developed, approved, and commercialized in the U.S. Closing of the definitive agreement is to occur no more than 90 days from the execution of the term sheet."This proposed transaction is a meaningful validation of the years of scientific, regulatory and manufacturing work PharmAla has invested in building ALA-002 into a credible, next-generation MDMA candidate," said Nicholas Kadysh, CEO. "Partnering with Jupiter Neurosciences gives ALA-002 a dedicated U.S. development and commercialization home, alongside a CNS-focused team and access to U.S. public capital markets, while PharmAla retains all rights to ALA-002 outside the United States and continues to expand our commercial footprint through Cortexa in Australia and our broader MDXX pipeline globally."CLEARMIND, YISSUM ENTER RESEARCH AGREEMENT:Clearmind Medicineannounced Monday the signing ofof the Hebrew University of Jerusalem. The agreement will fund a comprehensive preclinical study evaluating the metabolic efficacy of MEAI, both in combination with and as a maintenance therapy following tirzepatide treatment in diet-induced obese mice. The research will be conducted by Professor Joseph Tam and his team at the Obesity and Metabolism Laboratory at the Institute for Drug Research, School of Pharmacy, Hebrew University of Jerusalem.Building on results from its prior collaboration with Tam's laboratory, where MEAI demonstrated approximately 15–20% body weight reduction in DIO mice, primarily through increased energy expenditure and fat utilization while preserving lean mass and improving glucose homeostasis and hepatic steatosis, Clearmind is now advancing MEAI into combination and sequencing strategies with incretin therapy. The new 12-month study, titled "Assessing the Metabolic Efficacy of MEAI in Combination and Sequencing with Tirzepatide in Diet-Induced Obese Mice," will examine additive or synergistic effects when MEAI is administered concomitantly with tirzepatide and the potential of MEAI as a maintenance therapy to attenuate post-tirzepatide weight regain and preserve metabolic benefits across multiple doses."MEAI is designed to offer a differentiated mechanism that potentially complements incretin therapies," said Adi Zuloff-Shani, CEO. "While those drugs excel at reducing food intake, our previous preclinical data show MEAI significantly enhances energy expenditure. We believe that this combination and maintenance approach has potential to deliver more robust, durable, and clinically meaningful outcomes for patients."Additionally on Tuesday, Clearmind announced that it will conduct a reverse share split of its issued and outstanding common shares, no par value, at a ratio of 1-for-10. The reverse split is being effected as part of the company's plan to regain compliance with the Nasdaq Minimum Bid Price Rule and will be effective commencing May 21.GH RESEARCH PRICE TARGET CHANGES:H.C. Wainwright lowered the firm's price target on GH Researchon the shares. The firm cited share count dilution from the company's April offering for the target cut.Cantor Fitzgerald raised the firm's price target on GH Research to $35 from $25 and kept an Overweight rating on the shares. GH Research is viewed as operating in a large and expanding psychedelic therapy market with significant unmet mental health need, where long-term peak sales across related treatments could reach roughly $50B, the firm said. This supports a constructive demand backdrop despite ongoing uncertainty around competitive dynamics in the space, the analyst said.Citizens lowered the firm's price target on GH Research to $39 from $42 and kept an Outperform rating on the shares. GH Research reported continued progress with its GH001 program, reaffirmed plans to begin a pivotal Phase 3 trial in late 2026 following ongoing discussions with the FDA and ended the quarter with approximately $267M in cash, the firm said. The cash balance appears sufficient to fund the global development program, the analyst said.COMPASS PRICE TARGET RAISE:Maxim raised the firm's price target on Compass Pathwaystoon the shares. Compass Pathways reported Q1 results with an operating loss of ($42.9M) and ended the period with $466M, the analyst said. Compass's Commissioner's National Priority Voucher award should accelerate the company's commercial timelines, driving the firm's price target increase, the firm added.OTHER PSYCHEDELIC STOCKS:Publicly-traded companies in the space include Grey Matters Health, AtaiBeckley, BetterLife, Definium Therapeutics, Filament Health, Helus Pharma, Incannex, MIRA Pharmaceuticals, Numinus Wellness, Pasithea Therapeutics, PharmaTher, Psyence Biomedical, Psyence Group, Revive Therapeutics, Silo Pharmaand Sibannac.
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- Investor Capital Influx: Trump's executive order has sparked interest among investors in psychedelic drug development companies, with Enveric Biosciences raising $5 million following the announcement, indicating heightened market attention despite researchers cautioning that new treatments are still far from realization.
- Improved FDA-DEA Coordination: Nine executives and investors noted that the order could shorten administrative timelines and enhance coordination between the FDA and DEA, potentially saving clinical-stage companies tens of millions in costs and improving overall research efficiency.
- Reduced Regulatory Uncertainty: Sa'ad Shah, co-founder of Noetic Fund, highlighted that the executive order may attract institutional investors like sovereign wealth funds and public pension plans into the psychedelic sector, alleviating previous regulatory uncertainties and signaling credible government backing for the industry.
- Accelerated Development Processes: Robert Barrow, CEO of Definium Therapeutics, stated that the implementation of the order will streamline regulatory processes, particularly allowing the DEA to begin scheduling controlled substances after FDA approval, which will facilitate faster market access for psychedelic drugs.
- Financial Performance: Enveric Biosciences reported a Q1 GAAP EPS of -$1.08, indicating challenges in profitability that may affect investor confidence and lead to stock price volatility.
- Cash Position: As of March 31, 2026, the company had $4.9 million in cash on hand, reflecting tight liquidity that could limit future R&D and operational activities.
- Funding Activities: During the quarter, the company raised gross proceeds of $2.8 million through offerings, providing short-term funding support, yet still insufficient to cover ongoing operational losses.
- Future Funding Goals: Enveric Biosciences aims to raise up to $13.9 million through share and warrant offerings, a strategy that may help improve financial conditions but could also dilute existing shareholders' equity.
- Board Enhancement: Lakewood-Amedex Biotherapeutics has appointed Dr. Joseph Tucker to its Board of Directors, a move aimed at strengthening the company's governance capabilities, particularly following its recent direct listing on Nasdaq to enhance strategic decision-making.
- Rich Industry Experience: Dr. Tucker brings over 20 years of leadership experience in biotechnology, having served as CEO in multiple companies and successfully driving various financings and clinical programs, which is expected to provide valuable market insights for the company.
- Product Development Outlook: The company is developing its Nu-3 product for infected diabetic foot ulcers, which has the potential for rapid elimination of a broad spectrum of bacteria, with upcoming clinical trials set to further validate its safety and efficacy.
- Capital Market Strategy: Dr. Tucker's addition is viewed as a crucial step in accelerating the company's growth strategy, especially given his background of raising over $100 million in funding, which is expected to support future financing and market expansion efforts.
- Board Enhancement: Lakewood-Amedex Biotherapeutics has appointed Dr. Joseph Tucker to its Board of Directors, a move aimed at strengthening the company's governance capabilities to support its growth strategy following its recent Nasdaq listing.
- Rich Industry Experience: Dr. Tucker brings over 20 years of leadership experience in biotechnology, having served as CEO in multiple companies, successfully driving strategic financings and clinical programs, which is expected to provide valuable market insights for the company.
- Product Development Outlook: The company's Nu-3 product targets infected diabetic foot ulcers and has the potential to rapidly eliminate a broad spectrum of bacteria, expected to fill a significant gap in the market for antibiotic resistance treatments.
- Clinical Trial Plans: Based on initial clinical trial results, Lakewood-Amedex plans to conduct a Phase 2a safety and dose response study for Nu-3, further validating its efficacy in treating infected diabetic foot ulcers.
- Market Performance: The S&P 500 rose about 0.8% and the Nasdaq Composite increased by 1.63%, marking the fourth consecutive week of gains, driven by strong corporate earnings and policy support, reflecting robust investor confidence in tech stocks.
- Cannabis Sector Surge: Akanda Corp. (AKAN) shares skyrocketed over 300% this week after the Trump administration advanced plans to reclassify marijuana as a Schedule III drug, with single-day gains reaching 214%, igniting a rally across the cannabis sector.
- Strong Semiconductor Earnings: MaxLinear (MXL) shares surged more than 75% after reporting a 43% year-over-year revenue increase and raising guidance, highlighting robust demand for its optical and connectivity chips in AI data centers, showcasing the company's strong market position.
- Psychedelic Drug Development: Enveric Biosciences (ENVB) shares jumped over 100% following Trump's executive order to accelerate research and approval for psychedelic therapies, marking the company's best week ever and reflecting optimistic market sentiment towards mental health drug development.
- Regulatory Push: The FDA has announced plans to accelerate the development of psychedelic treatments to address serious mental health issues, particularly post-traumatic stress disorder and treatment-resistant depression, indicating strong support for innovative therapies.
- Presidential Directive: Last week, President Trump signed an executive order directing health agencies to expedite research on psychedelic substances like psilocybin, MDMA, and ibogaine, aiming to swiftly tackle the national mental health crisis, especially for veterans.
- Market Reaction: Following the FDA's new policy, shares of Compass Pathways Plc. (CMPS), Helus Pharma Inc. (HELP), and Enveric Biosciences Inc. (ENVB) rose between 2% and 7% in Friday's opening trade, reflecting investor optimism about the psychedelic drug market's potential.
- Industry Outlook: This FDA initiative not only paves the way for clinical applications of psychedelics but may also encourage more companies to enter this emerging market, thereby driving innovation and growth among related firms.










