CMPS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-11-03

• In September 2026, we announced Part C results from our Phase 3 COMP005 trial. The open-label Part C data demonstrate the following: (i) notable additional benefit was observed with an added reduction in MADRS score leading to an average 13-point reduction from baseline at week 52 and extended out t…

• Changes in policy or resources of governmental agencies, including, but not limited to, changes at the FDA, DEA, SEC, IRS and U.S. Patent and Trademark Office, could impact our business and results of operations. Despite Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illn…

• Research and development activities are central to our business model. Product or therapeutic candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-sta…

• We anticipate we will continue to incur significant accounting, audit, legal, regulatory and compliance costs, as well as investor and public relations expenses associated with being a public company. We have also incurred, and expect to continue to incur, significant pre-commercialization expenses …

• Three Months Ended September 30,Nine Months Ended September 30,

Text removed vs the prior filing · source: 10-Q · 2026-08-05

• Changes in policy or resources of governmental agencies, including, but not limited to, changes at the FDA, DEA, SEC, IRS and U.S. Patent and Trademark Office, could impact our business and results of operations. Despite Executive Order

• 14401, “Accelerating Medical Treatments for Serious Mental Illness,” issued on April 18, 2026, which seeks to expedite research, regulatory review, and patient access to psychedelic therapies for serious mental health conditions, the Trump administration could issue or promulgate executive orders, r…

• Research and development activities are central to our business model. Product or therapeutic candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-sta…

• We anticipate we will continue to incur significant accounting, audit, legal, regulatory and compliance costs, as well as investor and public relations expenses associated with being a public company. Subject to FDA approval, we anticipate increases in both personnel and other expenses as we prepare…

• For the three and six months ended June 30, 2026, the decrease in research and development expenses, as compared to the same period in 2025, was primarily attributable to the following:

Text added vs the prior filing · source: 10-Q · 2026-11-03

• Please see the information pertaining to legal proceedings in "Item 1. Financial Statements—Note 9. Commitments and Contingencies," to the interim consolidated financial statements, which is incorporated by reference herein.

Text added vs the prior filing · source: 10-Q · 2026-11-03

• •the progress, timing and completion of our rolling NDA submission and potential commercialization activities;

• a sufficient number of healthcare professionals or effectively manage their healthcare professionals, our business, financial condition and results of operations would be materially harmed.

• We have, and may in the future, set up research facilities and innovation labs, which we refer to as Centers of Excellence, in key markets. For example, in March 2022, we announced a strategic collaboration with King’s College London and South

• London and Maudsley NHS Foundation Trust, or SLaM, to establish The Center for Mental Health Research and Innovation to advance research in psychedelic treatments through, among other things, the development of working model psychedelic treatment clinics, our training programs, conducting clinical t…

• sufficient to cover such claims and our business, financial condition and results of operations could be materially adversely affected.

Text removed vs the prior filing · source: 10-Q · 2026-08-05

• •continue to advance our Phase 3 program for investigational COMP360 psilocybin treatment in TRD and clinical and preclinical supporting studies and continue preparing our rolling NDA submission;

• •the progress, timing and completion of our Phase 3 program for our current investigational COMP360 psilocybin treatment program for TRD and clinical supporting studies, our rolling NDA submission and potential commercialization activities, a portion of which are subject to further long-term data fr…

• and state fraud and abuse laws. In addition, a material change in our relationship with providers, whether resulting from a dispute among the entities, a change in government regulation, or the loss of these affiliations, could impair our ability to provide treatments and could have a material adver…

• appropriate by the FDA. The National Priority Review program is in pilot stage, so its implementation, operation, and ultimate benefits or impacts are subject to uncertainty.

• We have, and may in the future, set up research facilities and innovation labs, which we refer to as Centers of Excellence, in key markets. For example, in March 2022, we announced a strategic collaboration with King’s College London and South London and Maudsley NHS Foundation Trust, or SLaM, to es…