COMPASS Pathways Announces Third Quarter 2023 Financial Results and Business Highlights
Summary
Secured up to $285 million private placement financing with $125 million upfront Conference call on November 2 at 8:00 am ET (12:00 pm UK)LONDON, Nov. 02, 2023 (GLOBE NEWSWIRE) -- COMPASS Pathways plc (Nasdaq: CMPS) (COMPASS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the third quarter 2023 and provided an update on recent progress across its business.Kabir Nath, Chief Executive Officer, said, We continue to make progress in our COMP360 phase 3 program, most recently with the authorization to commence recruitment in a number of European clinical trial sites. The August financing, led by specialist biotech investors, provides a strong financial foundation that permits COMPASS to move forward confidently with our clinical programs, as well as all supporting studies for a potential new drug application filing with the FDA. Phase 3 program underway, composed of two pivotal trials with an integrated, long-term outcomes component Long-term follow up in each trial will generate data on duration of response and potential effect of retreatment Both phase 3 trials ongoing and on track Phase 2 study in post-traumatic stress disorder (PTSD) top-line data expected by the end of 2023 Publication of a paper in Psychopharmacology showing the potential of AI technologies to support investigational COMP360 psilocybin treatment in TRD Daphne Karydas appointed to the COMPASS Board of Directors Mary-Rose Hughes assumed the role of interim CFO after Mike Falvey departure; search for a permanent Chief Financial Officer commencedFinancial highlights In August, COMPASS completed a private placement pursuant to which it issued and sold to a select group of specialist biotech investors 16,076,750 American Depositary Shares (ADSs) and warrants to purchase up to 16,076,750 ADSs (the PIPE Warrants) at a purchase price of approximately $7.78 per ADS and accompanying warrant to purchase one ADS. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. 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 COMPASSs 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: we will require substantial additional funding to achieve our business goals, including to repay the term loan facility, 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 product development efforts; the availability of future tranches under the term loan facility is dependent, in part, on the approval of the lender, achievement of certain milestones and other factors; clinical development is lengthy and outcomes are uncertain, and therefore our clinical trials may be delayed or terminated; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any of future product candidates may be unsuccessful; our development efforts and our business strategy to set up research facilities and innovation labs involves significant costs and resources and may be unsuccessful; and our efforts to obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and those risks and uncertainties described under the heading Risk Factors in COMPASSs most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC) , which are available on the SECs website at www.sec.gov.