Psilocybin

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 first quarter 2026 financial results and business highlights. “With regulatory acceleration unfolding, we are working diligently towards our goal of completing the filing of a robust clinical package by Q4 and securing COMP360 approval,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “COMP360 represents a fundamentally different approach for patients with treatment resistant depression, unlike any other treatment approved today. Its transformative clinical profile has the potential to change what patients can expect in terms of both rapid and durable relief, and we are ready to deliver for those who have waited far too long for better options.” Business Highlights Accelerated regulatory path Approval timelines are tracking to Compass’ fastest projected expectations, supported by regulatory acceleration including a rolling New Drug Application (NDA) submission and the Commissioner’s National Priority Review Voucher (CNPV). NDA rolling submission underway: FDA granted Compass NDA rolling submission and review request, based on strength of positive Phase 3 data. Rolling submission and review are underway, with sections of the NDA already submitted. 26-week (Part B) data from COMP006, expected in early Q3 2026. The final NDA submission remains on track for Q4, aligned with the Company’s previously defined accelerated timing. FDA granted Compass NDA rolling submission and review request, based on strength of positive Phase 3 data. Rolling submission and review are underway, with sections of the NDA already submitted. 26-week (Part B) data from COMP006, expected in early Q3 2026. The final NDA submission remains on track for Q4, aligned with the Company’s previously defined accelerated timing. Post-NDA filing momentum: CNPV awarded for COMP360, Compass’ proprietary formulation of synthetic psilocybin for TRD, which has the potential to accelerate filing review time to be completed within 1-2 months. White House Executive Order on psychedelics treatments directs the Drug Enforcement Administration (DEA) to initiate and complete review of psychedelic treatment that has successfully completed Phase 3 trials so that rescheduling may proceed as quickly as possible. CNPV awarded for COMP360, Compass’ proprietary formulation of synthetic psilocybin for TRD, which has the potential to accelerate filing review time to be completed within 1-2 months. White House Executive Order on psychedelics treatments directs the Drug Enforcement Administration (DEA) to initiate and complete review of psychedelic treatment that has successfully completed Phase 3 trials so that rescheduling may proceed as quickly as possible. Advancing toward commercial launch Launch readiness: Compass will be launch ready by the end of the year and has assembled a highly experienced commercial leadership team. The team is advancing comprehensive launch preparedness efforts, including KOL and HCP education, payer engagement, and ongoing initiatives to support a timely federal and state rescheduling process. Compass will be launch ready by the end of the year and has assembled a highly experienced commercial leadership team. The team is advancing comprehensive launch preparedness efforts, including KOL and HCP education, payer engagement, and ongoing initiatives to support a timely federal and state rescheduling process. Delivery infrastructure readiness: COMP360 is expected to fit seamlessly across diverse healthcare settings within the current infrastructure of over 7,300 centers 1 offering multi-hour treatments Treatment centers are growing rapidly, and existing centers are already scaling in anticipation of a COMP360 launch and additional multi-hour psychedelic treatments coming to market. COMP360 is expected to fit seamlessly across diverse healthcare settings within the current infrastructure of over 7,300 centers 1 offering multi-hour treatments Treatment centers are growing rapidly, and existing centers are already scaling in anticipation of a COMP360 launch and additional multi-hour psychedelic treatments coming to market. COMP360’s transformative clinical profile COMP360 has the potential to offer a highly differentiated, transformative clinical profile and is expected to be a blockbuster opportunity. COMP360 is the first classic psychedelic 2 to consistently achieve a highly statistically significant result and clinically meaningful effect in 3 large late-stage trials involving more than 1,000 participants living with TRD, with a generally well-tolerated and safe profile. COMP360 demonstrates effects as quickly as within one day after administration with durability lasting at least through 6 months for those who achieve a clinically meaningful response after one or two doses. Financial Highlights Research and development expenses were $26.5 million for the three months ended March 31, 2026, compared with $30.9 million during the same period in 2025. The decrease was primarily driven by lower development expenses, reflecting reduced clinical trial costs as our Phase 3 program for COMP360 psilocybin therapy in TRD progresses toward completion, as well reduced discovery program expenses following the termination of certain programs in connection with the reorganization that took place in the fourth quarter of 2024 and the related contract terminations in 2025. General and administrative expenses were $16.4 million for the three months ended March 31, 2026, compared with $18.7 million during the same period in 2025. The decrease was primarily due to lower legal and professional fees, driven by higher financing-related costs in 2025, including those associated with warrant issuances, which were expensed as incurred, whereas a greater portion of such costs in 2026 were capitalized. This decrease was partially offset by increased consulting and legal advisory expenses. Net income for the three months ended March 31, 2026, was $91.2 million, or $0.71 net income per share (basic) and $0.30 net loss per share (diluted), compared with a net loss of $17.9 million, or $0.20 net loss per share (basic) and $0.24 net loss per share (diluted), during the same period in 2025. The increase in net income was primarily driven by a $130.9 million non-cash gain on fair value adjustment related to our warrants, compared with $19.5 million during the same period in 2025. As the fair value of the warrants fluctuates with our share price, this adjustment can result in significant variability in our reported net income or net loss. Cash and cash equivalents were $466.0 million as of March 31, 2026, compared with $149.6 million as of December 31, 2025. Debt was $50.5 million as of March 31, 2026, compared with $31.6 million as of December 31, 2025. Financial Guidance The current cash position is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2028. 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 synthetic 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 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 expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD; our plans and expectations regarding our clinical trials, including our phase 3 trials in TRD and our phase 2b/3 trial in PTSD; our expectations regarding the time periods for the release of data from Part B of the COMP006 Phase 3 trial for TRD; any implication that past results will be predictive of future results; our expectations regarding the timing of our rolling submission of a new drug application, or NDA, for COMP360 psilocybin treatment in TRD and the timing of the review by the Food and Drug Administration, or FDA, of such NDA, including potential acceleration due to the grant of rolling review and award of a Commissioner’s National Priority Voucher, or CNPV, for COMP360 psilocybin treatment in TRD; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our expectations regarding potential commercial launch timelines and our commercial readiness; our efforts and 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, on an accelerated timeline or at all; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD. 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 full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results to date; our need for 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; that the rolling review process and/or the Commissioner's National Priority Voucher pilot program may not actually lead to a faster FDA review or approval process; our efforts to obtain FDA approval, or approval from regulatory authorities in other jurisdictions, for our investigational COMP360 psilocybin treatment on an accelerated basis, or at all, 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 www.sec.gov. 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. References Data on file For the definition of classic psychedelic, see Vollenweider, F.X. and Smallridge, J.W., 2022. Classic psychedelic drugs: update on biological mechanisms. Pharmacopsychiatry, 55(03), pp.121-138 Enquiries Media: Dana Sultan-Rothman, media@compasspathways.com Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324 COMPASS PATHWAYS PLC Condensed Consolidated Balance Sheets (unaudited) (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) March 31, December 31, 2026 2025 ASSETS CURRENT ASSETS: Cash and cash equivalents $466,010 $149,608 Restricted cash 379 379 Prepaid expenses and other current assets 44,478 41,503 Total current assets 510,867 191,490 NON-CURRENT ASSETS: Operating lease right-of-use assets 2,861 3,424 Deferred tax assets 4,098 3,751 Long-term prepaid expenses and other assets 13,913 11,684 Total assets $531,739 $210,349 LIABILITIES AND SHAREHOLDERS' EQUITY/(DEFICIT) CURRENT LIABILITIES: Accounts payable $10,877 $15,222 Accrued expenses and other liabilities 8,984 9,214 Debt, current portion — 17,523 Operating lease liabilities - current 2,054 2,110 Warrant liabilities 131,882 203,726 Total current liabilities 153,797 247,795 NON-CURRENT LIABILITIES: Debt, non-current portion 50,476 14,110 Operating lease liabilities - non-current 779 1,292 Total liabilities $205,052 $263,197 SHAREHOLDERS' EQUITY/(DEFICIT): Ordinary shares, £0.008 par value; 134,923,295 and 96,085,785 shares authorized, issued and outstanding at March 31, 2026 and December 31, 2025, respectively 1,393 973 Additional paid-in capital 1,071,481 783,562 Accumulated other comprehensive loss (14,795) (14,789) Accumulated deficit (731,392) (822,594) Total shareholders' equity/(deficit) 326,687 (52,848) Total liabilities and shareholders' equity/(deficit) $531,739 $210,349 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, 2026 2025 OPERATING EXPENSES: Research and development $26,480 $30,880 General and administrative 16,424 18,736 Total operating expenses 42,904 49,616 Loss from operations: (42,904) (49,616) OTHER INCOME (EXPENSE), NET: Fair value change of warrant liabilities 130,916 19,460 Benefit from R&D tax credit 2,477 8,448 Interest income 2,419 2,386 Interest expense (1,465) (1,124) Foreign exchange (losses) gains (736) 2,133 Other income 484 803 Total other income, net 134,095 32,106 Income (loss) before income taxes 91,191 (17,510) Income tax benefit (expense) 11 (354) Net income (loss) $91,202 $(17,864) Net income (loss) per share attributable to ordinary shareholders: basic $0.71 $(0.20) Weighted average ordinary shares outstanding: basic 110,064,581 89,192,252 Net loss per share attributable to ordinary shareholders: diluted $(0.30) $(0.24) Weighted average ordinary shares outstanding: diluted 130,266,693 98,641,623 Net income (loss) $91,202 $(17,864) Other comprehensive income (loss): Foreign exchange translation adjustment (6) (117) Comprehensive income (loss) $91,196 $(17,981)

MORRISTOWN, N.J., May 11, 2026 (GLOBE NEWSWIRE) -- Reunion Neuroscience, Inc., a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic-inspired therapeutic solutions, today announced that it will share the full results of the RECONNECT, a Phase 2 trial evaluating luvesilocin in adult female patients with moderate-to-severe postpartum depression (PPD), in an oral presentation at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting 2026 – Psychiatry and AI: Promises, Perils, and Pathways Forward in Miami, FL. As previously presented in a poster session at the American College of Neuropsychopharmacology (ACNP) Annual Meeting, RECONNECT met its primary endpoint, with a statistically significant and clinically meaningful reduction in depression as measured by the MADRS total score observed on Day 7. Clinically meaningful reductions in MADRS were observed for luvesilocin 30mg-treated patients on the first day following administration and maintained through the 28-day follow-up. Substantial and clinically meaningful improvements in other key secondary endpoints, including MADRS response and remission rates and other measures of PPD-related symptoms, were also observed. Based on these data, Reunion Neuroscience aligned with the U.S. Food and Drug Administration (FDA) on a registrational path for luvesilocin in PPD. The Company expects to advance luvesilocin into a pivotal Phase 3 trial in 2026. Based on feedback from the FDA, Reunion expects that the results from this single Phase 3 trial, if successful, would complete the data package required to support potential registration of luvesilocin in PPD. Details of the ASCP presentation are as follows: Title: RE104: A Novel Serotonergic Psychedelic 4-OH-DiPT Prodrug for the Treatment of Postpartum Depression Session: Pharmaceutical Pipeline Session Session Date and Time : Tuesday, May 26, 2026 from 2:00 – 4:00 PM ET Presentation Time: Tuesday, May 26, 2026 from 2:00 – 2:10 PM ET Presenter: Mark Pollack, M.D., Chief Medical Officer, Reunion Neuroscience Reunion Neuroscience will also present data in a poster session entitled, “RE104: A Novel Psychedelic Agent for Postpartum Depression,” at the 2026 American Psychiatric Association (APA) Annual Meeting, May 18, 2026 in San Francisco, CA. About Luvesilocin Luvesilocin is a proprietary, potential best-in-class, patented prodrug of 4-OH-DiPT, which is administered via a subcutaneous injection. Reunion designed luvesilocin to deliver rapid efficacy with a short psychoactive experience, making luvesilocin more convenient than the longer experience and monitoring required with psychedelics like psilocybin or LSD. Reunion is evaluating luvesilocin as a subcutaneous administration for the treatment of mood and anxiety disorders, including PPD, adjustment disorder (AjD), generalized anxiety disorder (GAD) and other potential indications. Following positive data from the Phase 2 RECONNECT trial, the U.S. Food and Drug Administration granted luvesilocin Breakthrough Therapy Designation in PPD. Reunion expects to initiate a pivotal Phase 3 clinical trial in PPD in 2026, which, if successful, could support potential registration of luvesilocin. Additionally, Reunion is enrolling patients in the Phase 2 REKINDLE ( NCT07002034 ) clinical trial in patients with AjD related to cancer and other medical illnesses and the Phase 2 RECLAIM ( NCT07489651 ) clinical trial in patients with GAD. About Reunion Neuroscience, Inc. Reunion Neuroscience is a clinical-stage biopharmaceutical company committed to revolutionizing the treatment of underserved mental health disorders through the advancement of next-generation psychedelic-inspired therapeutic solutions. Reunion is actively investigating the use of its lead product candidate, luvesilocin, in postpartum depression, adjustment disorder and generalized anxiety disorder and may in the future expand to additional neuropsychiatric indications where there remains a significant unmet need that is not addressed by the current standard of care. Reunion has advanced a lead candidate, RE245, from its non-psychedelic discovery program and plans to IND in 2026. To learn more, visit , and follow Reunion on LinkedIn and Bluesky . For further information: IR Inquiries: Hannah Deresiewicz Precision AQ hannah.deresiewicz@precisionaq.com PR Inquiries: Ashley Murphy Precision AQ ashley.murphy@precisionaq.com