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Yahoo
09-05-2025
- Business
- Yahoo
Psychedelic: Compass, GH Research, MindMed report quarterly earnings
In this week's 'Psychedelic,' The Fly's recurring series focused on psychedelic stock news, The Fly looks back on earnings, a patent grant and study results. Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. Q1 EARNINGS: On Thursday, Compass Pathways (CMPS) reported a first quarter loss per share of (24c), which compared to analyst estimates of a loss per share of (49c). The company said cash and cash equivalents were $260.1M as of March 31, compared with $165.1M as of December 31. Compass also guided to full year 2025 net cash used in operating activities in the range of $120M to $145M. The cash position at March 31 is expected to be sufficient to fund operating expenses and capital expenditure requirements at least through the planned 26-week data read-out from the COMP006 study, which is expected in the second half of 2026. 'We eagerly await the upcoming topline 6-week data readout, on track for late June, the first data from our pivotal phase 3 COMP360 program in treatment resistant depression.' said Kabir Nath, CEO. 'Our continued progress reinforces Compass' leadership in psychedelic therapy development, which we believe represents the next generation of mental health therapeutic options and can lead to significant value creation.' GH Research (GHRS) also reported Q1 results Thursday with a loss per share of (19c), which compared to analyst consensus of a loss per share of (20c). Cash, cash equivalents, other financial assets and marketable securities were $315.3M as of March 31, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6M as of December 31. Gross proceeds from public offering in Q1 were $150M. Additionally on Thursday, Mind Medicine (MNMD) reported a Q1 loss per share of (35c), which compared to analyst estimates of a loss per share of (37c). Cash, cash equivalents and investments totaled $245.5M as of March 31. The company believes that its cash, cash equivalents, and investments as of March 31 will be sufficient to fund the company's operations into 2027. Based on the company's current operating plan and anticipated R&D milestones, the company expects its cash runway to extend at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in General Anxiety Disorder. 'We are proud to share that all three of our pivotal Phase 3 trials evaluating MM120 ODT in patients with GAD and MDD—Voyage, Panorama, and Emerge—are actively enrolling. Momentum is building, with strong and growing enthusiasm from both clinical sites and patients as recruitment continues to accelerate,' said Rob Barrow, CEO. 'We're on track to report topline data from Voyage in the first half of 2026, followed by Panorama and Emerge in the second half of the year. With our breakthrough therapy designation in GAD, a clearly defined regulatory strategy, and strong operational execution across our programs, we're delivering on our goal of advancing MM120 ODT as a potential best-in-class, differentiated therapeutic option. Our team remains fully committed to delivering transformational innovation for the over 50 million people in the U.S. living with GAD or MDD as we drive toward commercialization.' CYBIN ANNOUNCES U.S. PATENT GRANT: Cybin (CYBN) announced Thusday that the United States Patent and Trademark Office has granted U.S. patent 12,291,499 in support of its CYB003 program in Major Depressive Disorder. The patent, which is expected to provide exclusivity until 2041, includes claims to pharmaceutical compositions and oral dosage forms within the company's proprietary deuterated psilocin analog program, CYB003. 'Securing an additional patent in support of CYB003 provides important validation of our program and reinforces the commercial potential of our pipeline,' said Doug Drysdale, CEO. 'Robust patent protection is essential for drug development companies, and we are proud of our expanding intellectual property portfolio. As we continue to dose patients in our first Phase 3 study, we are focused on execution, delivering shareholder value, and ultimately, creating more effective treatments for those with mental health disorders.' MIRA REPORTS KETAMIR-2 NEUROTOXICITY RESULTS: On Tuesday, MIRA Pharmaceuticals (MIRA) announced results from a neurotoxicity study of Ketamir-2, its novel oral NMDA receptor antagonist. The study was required by the U.S. Food and Drug Administration prior to initiating human dosing in the United States. The preclinical study showed no evidence of brain toxicity, including the absence of Olney lesions-vacuolar brain changes historically associated with older NMDA-targeting drugs such as ketamine and MK-801. The neurotoxicity study was conducted in sexually mature Sprague-Dawley rats. High oral doses of Ketamir-2 were administered, while a positive control group received MK-801, a known neurotoxic NMDA receptor antagonist. Brain tissues were examined through detailed histopathological analysis at two time points. Key outcomes included no adverse clinical signs or mortality in any Ketamir-2-treated animals; No microscopic or macroscopic brain lesions detected at any dose; MK-801-treated animals showed clear evidence of brain toxicity, including vacuolation and neuronal necrosis. 'These results represent a key milestone in the development of Ketamir-2,' said Erez Aminov, CEO. 'The absence of NMDA-linked neurotoxicity, along with continued clinical progress, reinforces our confidence in Ketamir-2's potential as a safe next-generation, oral candidate for CNS disorders.' Additionally on Thursday, MIRA announced that its Board of Directors has approved the planned acquisition of SKNY Pharmaceuticals, following the completion of independent valuation reports on both companies. The merger remains subject to MIRA and SKNY's shareholder approval. A third-party analysis conducted by Moore Financial Consulting assigned SKNY Pharmaceuticals an enterprise value of approximately $30.5M, based on a risk-adjusted net present value of its lead compound, SKNY-1. MIRA was separately valued by Moore at $30M. As outlined in the previously announced binding letter of intent for the merger, upon the closing, SKNY must hold at least $5M in cash or other assets, to be transferred at closing, and the company is preparing a filing with the U.S. Securities and Exchange Commission to seek shareholder approval. BRIGHT MINDS INITIATED WITH BUY: On Wednesday, Chardan initiated coverage of Bright Minds (DRUG) with a Buy rating and $80 price target. The firm cites the potential of the company's lead asset BMB-101 for the treatment of epilepsy for the Buy rating. Bright Minds is an 'interesting story even at current valuation: as BMB-101 could be differentiated verses other 5-HT2C agonists with its unique binding profile, and it could potentially achieve greater than $1B peak sales in epilepsy, the analyst said. NRXP FILES PATENT APPLICATION: NRx Pharmaceuticals (NRXP) announced Monday the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the U.S. Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045. 'We are committed to delivering safer, more effective treatments for patients with suicidal depression,' said Jonathan Javitt, CEO. 'NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need.' OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Clearmind (CMND), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex (IXHL), Mydecine Innovations (MYCOF), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on CMPS: Disclaimer & DisclosureReport an Issue Compass Pathways reports Q1 EPS (24c), consensus (49c) Compass Pathways enters strategic collaboration with HealthPort Psychedelic: Clearmind completes clinical site initiations for AUD trial Compass Pathways completes dosing in Part A of Phase 3 psilocybin trial COMPASS Pathways Amends Executive Employment Agreements
Business Wire
08-05-2025
- Business
- Business Wire
Compass Pathways Announces First Quarter 2025 Financial Results and Business Highlights
LONDON & NEW YORK--(BUSINESS WIRE)--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2025 and provided an update on recent progress across its business. 'We eagerly await the upcoming topline 6-week data readout, on track for late June, the first data from our pivotal phase 3 COMP360 program in treatment resistant depression.' said Kabir Nath, Chief Executive Officer. 'Our continued progress reinforces Compass' leadership in psychedelic therapy development, which we believe represents the next generation of mental health therapeutic options and can lead to significant value creation.' Business Highlights COMP360 psilocybin treatment in TRD (Treatment Resistant Depression) The pivotal phase 3 clinical program of COMP360 psilocybin treatment in TRD is the largest-to-date randomized, controlled, double-blind psilocybin treatment clinical program. All participants have completed dosing in part A of the COMP005 phase 3 trial for TRD and top-line 6-week (primary endpoint) data are expected in late June. 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial. COMP006 26-week data is expected in the second half of 2026. Recent 52-week data from an observational follow-up study published on COMP360 demonstrated a durable treatment response and a median time to depressive event of 92 days (n=252) on a single 25mg administration and 189 days (n=58) for the 25mg subgroup that continued into the COMP004 long-term extension COMP360 psilocybin treatment in PTSD (Post Traumatic Stress Disorder) Company designing late-stage clinical trial program Phase 2 open label 12-week safety and tolerability study (n=22) announced in May 2024, showed COMP360 was well tolerated and demonstrated both rapid and durable improvement in symptoms from baseline observed following a single administration. Financial highlights Net loss for the three months ended March 31, 2025, was $17.9 million, or $0.20 net loss per share: basic, $0.24 net loss per share: diluted, compared with $35.2 million, or $0.55 loss per share basic and diluted, during the same period in 2024. The decrease in net loss for the quarter was primarily driven by a $19.5 million non-cash gain on fair value adjustment related to our warrant liabilities. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss. Non-cash share-based compensation for the three months ended March 31, 2025 was $3.9 million compared with $5.1 million for the same period in 2024. Research and development expenses were $30.9 million for the three months ended March 31, 2025, compared with $24.9 million during the same period in 2024. The increase was primarily attributable to development expenses associated with advancing our late-stage COMP360 phase 3 clinical trials partially offset by decreased personnel and non-cash share-based compensation expenses due to decreased staffing levels associated with the strategic reorganization that took place in the fourth quarter of 2024. General and administrative expenses were $18.7 million for the three months ended March 31, 2025, compared with $13.7 million during the same period in 2024. The increase was primarily attributable to issuance costs related to the 2025 Financing as well as expenses associated with consulting, accounting and legal advice. Gain on change in fair value of warrants for the three months ended March 31, 2025, was $19.5 million compared with $0.0 million during the same period in 2024. Cash and cash equivalents were $260.1 million as of March 31, 2025, compared with $165.1 million as of December 31, 2024. An additional $140.4 million net cash raised in the first quarter of 2025. Financial Guidance Full year 2025 net cash used in operating activities is expected to be in the range of $120 million to $145 million. The cash position at March 31, 2025 is expected to be sufficient to fund operating expenses and capital expenditure requirements at least through the planned 26-week data read-out from the COMP006 study, which is expected in the second half of 2026. Conference call The management team will host a conference call at 8:00 am ET (1:00 pm UK) on May 8, 2025. A live webcast of the call will be available on the Compass Pathways website at First Quarter 2025 Financial Results. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as 'may', 'might', 'will', 'could', 'would', 'should', 'expect', 'intend', 'plan', 'objective', 'anticipate', 'believe', 'contemplate', 'estimate', 'predict', 'potential', 'continue' and 'ongoing,' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding our financial guidance; our business strategy and goals; our expectations and projections about the company's future cash needs and financial results; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the time periods during which the results of the two Phase 3 trials will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD, PTSD, and anorexia nervosa; our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that our strategic collaborations will not continue or will not be successful; and our ability to retain key personnel; and those risks and uncertainties described under the heading 'Risk Factors' in Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q, the prospectus supplement related to the proposed public offering we plan to file and in other reports we have filed with the U.S. Securities and Exchange Commission ('SEC'), which are available on the SEC's website at Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass's current expectations and speak only as of the date hereof. COMPASS PATHWAYS PLC Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) Three Months ended March 31, 2025 2024 OPERATING EXPENSES: Research and development $ 30,880 $ 24,901 General and administrative 18,736 13,672 Total operating expenses 49,616 38,573 Loss from operations: (49,616 ) (38,573 ) OTHER INCOME (EXPENSE), NET: Fair value change of warrant liabilities 19,460 — Benefit from R&D tax credit 8,448 3,101 Interest income 2,386 2,260 Foreign exchange gains (losses) 2,133 (783 ) Interest expense (1,124 ) (1,098 ) Other income 803 128 Total other income, net 32,106 3,608 Loss before income taxes (17,510 ) (34,965 ) Income tax expense (354 ) (222 ) Net loss $ (17,864 ) $ (35,187 ) Net loss per share attributable to ordinary shareholders: basic $ (0.20 ) $ (0.55 ) Weighted average ordinary shares outstanding: basic 89,192,252 64,222,178 Net loss per share attributable to ordinary shareholders: diluted $ (0.24 ) $ (0.55 ) Weighted average ordinary shares outstanding: diluted 98,641,624 64,222,178 Net loss $ (17,864 ) $ (35,187 ) Other comprehensive loss: Foreign exchange translation adjustment (117 ) (36 ) Comprehensive loss $ (17,981 ) $ (35,223 ) Expand
Yahoo
25-04-2025
- Business
- Yahoo
Why Compass Pathways Stock Was a Double-Digit Winner This Week
The field of psychedelic medicine is relatively new, and because of this, certain investors consider it to be loaded with potential. That's why even minor events in companies specializing in this can be greeted with notable share price pops. Such a dynamic was in evidence with U.K.-based Compass Pathways (NASDAQ: CMPS) this week. On news about a step completed in a clinical trial, the company's shares rose by 13% over the period, according to data compiled by S&P Global Market Intelligence. Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now. Continue » Compass Pathways, which focuses on psilocybin -- the psychoactive compound found in "magic" mushrooms -- announced Tuesday that it had completed dosing in a late-stage clinical trial. The biotech is currently putting its synthesized psilocybin treatment, COMP005, through its paces in a phase 3 trial. Participants are to receive either a 25-milligram dose of the medication or a placebo. Promisingly, we should have a readout before long, as Compass Pathways said it is on pace to publish six-week primary endpoint results toward the end of June. The study comprises 258 patients currently afflicted with moderate to severe depression and who have not responded to a minimum of two previous treatments. The dosing took place at 32 sites in the U.S. In the press release marking the milestone, Compass Pathways quoted CEO Kabir Nath as saying that it "marks a critical milestone in our mission to address the pressing unmet need in treatment resistant depression." It also further establishes once-taboo psychoactive substances as legitimate potential therapies for serious psychological disorders. Investors will be crossing their fingers for success with this late-stage round of testing. Before you buy stock in Compass Pathways Plc, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Compass Pathways Plc wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $591,533!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $652,319!* Now, it's worth noting Stock Advisor's total average return is 859% — a market-crushing outperformance compared to 158% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of April 21, 2025 Eric Volkman has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Why Compass Pathways Stock Was a Double-Digit Winner This Week was originally published by The Motley Fool Sign in to access your portfolio
