CMPS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-13

• In February 2026, we announced the successful achievement of the primary endpoint in our ongoing Phase 3 COMP006 trial and Part B results from our ongoing Phase 3 COMP005 trial. We reported that the COMP006 trial achieved its primary endpoint with two fixed doses, administered 3 weeks apart, of COMP…

• Following these data read-outs and discussions with the FDA, the FDA granted our request for a rolling review. In April 2026, the FDA issued a Commissioner’s National Priority Voucher, or CNPV, for COMP360 psilocybin treatment in TRD.

• Beyond TRD, we have been exploring other indications, including PTSD. In May 2024, we completed and announced top-line results from our open label Phase 2 study to assess the safety and tolerability of COMP360 psilocybin treatment in participants with PTSD, as a result of trauma experienced as adult…

• Based on the data from this trial, we determined to advance development of COMP360 for PTSD and finalized the design of a Phase 2b/3 clinical trial in PTSD. In January 2026, the FDA accepted our IND application for COMP360 in PTSD, enabling the initiation of a Phase 2b/3 (COMP202) clinical trial in …

• On June 30, 2023, we entered into a loan agreement with Hercules, which provided for aggregate maximum borrowings of up to $50.0 million, including a term loan of $30.0 million, which was funded on June 30, 2023. On January 5, 2026, we entered into a third amendment to the Loan Agreement with Hercul…

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• was blinded through 6 weeks; Part B, which remains blinded through week 26; and Part C, which contains an open-label treatment part from week 26 to 52.

• In September 2025, we met with the U.S. Food and Drug Administration, or the FDA, and as part of that meeting discussed our NDA submission strategy. Based on such discussions, we plan to submit a proposal for rolling submission and formal request for rolling review of our NDA to the FDA.

• We have completed enrollment for the second pivotal trial, the COMP006 trial, and enrolled 585 participants. The COMP006 trial is comprised of three parts: Part A, which is blinded through 9 weeks, Part B which remains blinded through week 26, and Part C, which contains an open-label treatment part …

• We plan to disclose primary endpoint and safety data from Part A (9 weeks) of the COMP006 trial at the same time that we disclose the 6-week and 26-week MADRS data and safety data from the COMP005 trial in the first quarter of 2026. In addition, we expect to disclose the 26-week data from the COMP00…

• Beyond TRD, we have been exploring other indications, including PTSD. In May 2024, we completed and announced top-line results from our open label Phase 2 study to assess the safety and tolerability of COMP360 psilocybin treatment in participants with PTSD, as a result of trauma experienced as adult…

Text added vs the prior filing · source: 10-Q · 2026-05-13

• Our management, with the participation of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d…

• There were no changes in our internal control over financial reporting during the three months ended March 31, 2026 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• Our management, with the participation of our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively), evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d…

• our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, wi…

• There were no changes in our internal control over financial reporting during the three months ended September 30, 2025 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Text added vs the prior filing · source: 10-Q · 2026-05-13

• •we prepare for commercial launch of COMP360 psilocybin treatment in TRD, if approved, including establishing a sales, marketing and distribution infrastructure and scaling-up manufacturing capabilities;

• •initiate and advance our Phase 2b/3 clinical trial in PTSD;

• •establish and expand the network of public healthcare institutions and private clinics that could administer our investigational COMP360 psilocybin treatment if approved;

• Unless and until we generate product revenue and achieve and sustain profitability, we will continue to need additional financing to fund our operations and capital expenditures. Failure to obtain additional funding when needed or on favorable terms may force us to delay, limit or terminate certain …

• research operations or commercialization efforts or grant rights to develop and market products or therapeutic candidates that we would otherwise prefer to develop and market ourselves.

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• •initiate and advance a late-stage development program in PTSD;

• •establish a sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any therapeutic candidates for which we may obtain regulatory approval, including COMP360;

• •establish and expand the network of public healthcare institutions and private clinics that administer our investigational COMP360 psilocybin treatment if approved;

• We will need substantial additional funding to complete the development and commercialization of our investigational COMP360 psilocybin treatment or any future therapeutic candidates. Failure to obtain additional funding when needed or on favorable terms may force us to delay, limit or terminate cer…

• We expect to require substantial additional funding in the future to sufficiently finance our operations and to complete the development and commercialization of our investigational COMP360 psilocybin treatment or any future therapeutic candidates. Under the terms of the 2025 ADS Warrants, following…