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COMPASS Pathways plc announces first quarter 2022 financial results and business highlights

Highlights:

  • End of phase II meeting held with FDA
  • Award of Innovation Passport as part of the UK MHRA Innovative Licensing and Access Pathway ILAP
  • Finalising phase III in TRD program design to be ready for second half of 2022
  • Pioneering collaboration with King’s College London and South London and Maudsley NHS Foundation Trust, to create The Centre for Mental Health Research and Innovation in the UK
  • Cash position at 31 March 2022 of $243.7 million
  • Conference call today at 8:00am ET (1:00pm UK)

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2022 and gave an update on recent progress across its business.

COMPASS made great progress this quarter including a productive end-of-phase II FDA meeting and we are actively working to finalise our phase III programme. Moreover, we continue to push the boundaries of brain health research as we broaden our pipeline and partnerships. This includes our clinical trial of COMP360 therapy in post-traumatic stress disorder, or PTSD, a condition of significant unmet need for improved patient outcomes. Our strong cash position enables us to move forward at pace.

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

Business highlights

COMP360 psilocybin therapy in treatment-resistant depression (TRD):

  • Positive results from groundbreaking phase IIb clinical trial
  • Positive results from open-label study of 25mg COMP360 psilocybin therapy as adjunct to selective serotonergic reuptake inhibitor, or SSRI, antidepressants
  • End-of-phase II meeting held with FDA in April 2022
  • Award of Innovation Passport as part of the UK MHRA Innovative Licensing and Access Pathway (ILAP).
  • Finalising Phase III in TRD programme to be ready for second half of 2022
  • FDA granted breakthrough therapy designation
  • 10 granted patents issued to date covering composition, formulation and method of use

Additional COMP360 development programmes:

  • Phase II trial in PTSD ongoing at Kings College London
  • Investigator-led study in adults with autism spectrum disorder (ASD) announced, the first ever study of psilocybin in adults with ASD, co-sponsored by Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London and South London and Maudsley NHS Foundation Trust
  • Positive early signals seen in investigator-initiated studies in anorexia nervosa and severe treatment-resistant depression, presented at the Society of Biological Psychiatry Annual Meeting in New Orleans
  • Investigator-initiated studies underway across additional indications including new study in autism sponsored
  • Identification of new potential novel drug candidates through the COMPASS Discovery Center and an exclusive research project with Dr Matthias Grill
  • Strategic partnership formed to launch The Centre for Mental Health Research and Innovation to accelerate research and develop new models of mental healthcare in the UK

Financial highlights

  • Net loss for the three months ended 31 March 2022 was $21.2 million, or $0.50 loss per share (after including non-cash share-based compensation expense of $3.1 million), compared with $12.7 million or $0.35 loss per share, during the same period in 2021 (after including non-cash-share-based compensation expense of $1.7 million).
  • R&D expenses were $15.4 million for the three months ended 31 March 2022, compared with $6.9 million during the same period in 2021. Of this increase, $5.1 million was attributable to increased external development expenses as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. A further $2.6 million and $1.0 million were attributable to personnel expenses and non-cash share-based compensation respectively, due to increased headcount. This was partially offset by a decrease of $0.2 million in other expenses.
  • G&A expenses were $10.1 million for the three months ended 31 March 2022 compared with $6.7 million during the same period in 2021. The increase was attributable to an increase of $1.0 million and $0.5 million in personnel expenses and non-cash share-based compensation respectively, due to increased headcount. There was a further increase of $1.4 million in legal and professional fees and $0.4 million in facilities and other expenses.
  • Cash and cash equivalents were $243.7 million as of 31 March 2022 compared with $273.2 million as of 31 December 2021.

Conference call

The COMPASS Pathways management team will host a conference call at 1.00pm UK (8.00am ET) on 10 May 2022. The call can be accessed by dialing 1-800-926-7358 from the United States, 1-212-231-2914 internationally, and 0800-496-0823 from the UK, followed by the conference ID: 22018578

The call will also be webcast on the COMPASS Pathways website and archived for 30 days. For more information, please visit the COMPASS Pathways website (ir.compasspathways.com).

To view the original press release in its entirety click here

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