COMPASS Pathways announces financial results for the fourth quarter and full year 2021 and business highlights

“With our end-of-phase II meeting now scheduled with the FDA, we will be finalising our phase III programme design for an expected start in the second half of the year. Moving into phase III is another important step towards providing a much-needed therapeutic option for patients suffering with treatment-resistant depression and extends our leadership in this area of science with the most extensive evidence package to date. At the same time, we continue to broaden our pipeline through a phase II trial in PTSD, ongoing investigator-initiated studies, and development of new compounds through our Discovery Center and our partnership with Dr Matthias Grill of MiHKAL GmbH.”

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways

• Positive results from groundbreaking phase IIb clinical trial; additional data shows patient improvements beyond reduction of depression symptoms, including in positive affect and quality of life
• Positive results from open-label study of 25mg COMP360 psilocybin therapy as adjunct to SSRI antidepressants in TRD
• End-of-phase II meeting scheduled with FDA for late April 2022
• Phase III programme expected to begin in second half of 2022

• Phase II trial in post-traumatic stress disorder (PTSD) launched at King’s College London
• Positive results reported from two investigator-led clinical studies in major depressive disorder, one of which has been published in The New England Journal of Medicine
• Additional investigator-initiated studies ongoing in multiple indications

• Development of new product candidates through exclusive research project with Dr Matthias Grill of MiHKAL GmbH, complementing work being done at COMPASS’s Discovery Center

• 10 granted patents issued to date covering composition, formulation and method of use
• Several additional patent filings completed

• New senior executives appointed, including Dr Guy Goodwin as Chief Medical Officer, Mike Falvey as Chief Financial Officer, and Matt Owens as General Counsel and Chief Legal Officer
  

• Net loss for the year ended 31 December 2021 was $71.7 million, or $1.79 loss per share (after including non-cash share-based compensation expense of $8.6 million), compared with $60.3 million or $3.55 loss per share, during the same period in 2020 (after including non-cash-share-based compensation expense of $18.0 million)
  
• Net loss for the three months ended 31 December 2021 was $25.7 million, or $0.61 loss per share (after including non-cash share-based compensation expense of $2.8 million), compared with $18.8 million, or $0.52 loss per share, during the same period in 2020 (after including non-cash share-based compensation expense of $1.4 million)
  
• Research & development (R&D) expenses were $44.0 million for the year ended 31 December 2021, compared with $23.4 million during the same period in 2020. The increase was attributable to an increase of $16.1 million, $6.0 million and $0.4 million respectively in development expenses, personnel expenses and other expenses, partially offset by a reduction of $1.8 million in non-cash share-based compensation, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches
  
• R&D expenses were $13.6 million for the three months ended 31 December 2021, compared with $4.5 million during the same period in 2020. The increase was attributable to an increase of $7.3 million, $2.1 million and $1.0 million respectively in development expenses, personnel expenses and non-cash share-based compensation partially offset by a reduction of $1.3 million in other expenses

• General & Administrative (G&A) expenses were $39.1 million for the year ended 31 December 2021, compared with $28.0 million during the same period in 2020. The increase was attributable to an increase of $7.9 million, $1.8 million and $9.0 million respectively in personnel expenses, legal and professional fees and facilities and other expenses partially offset by a reduction of $7.6 million in non-cash share-based compensation expenses
  
• G&A expenses were $14.7 million for the three months ended 31 December 2021 compared with $7.0 million during the same period in 2020. The increase was attributable to an increase of $2.2 million, $0.5 million, $1.0 million and $4.0 million respectively in personnel expenses, non-cash share-based compensation, legal and professional fees and facilities and other expenses
  
• Cash and cash equivalents were $273.2 million as of 31 December 2021 compared with $190.3 million as of 31 December 2020