COMPASS Pathways Announces Q2 2022 Financial Results and Business Highlights

LONDON, UK– COMPASS Pathways plc (Nasdaq: CMPS), a health care company dedicated to accelerating innovation in mental health, today reported its financial results for the second quarter 2022 and gave an update on recent progress across its business.

George Goldsmith, Executive Chairman of COMPASS Pathways, (main image) said, “Our decision to appoint Kabir Nath as our new CEO comes at the ideal time as we enter the late stages of COMP360 development and plan for regulatory approval and commercialization. Kabir’s dedication to our mission, extensive experience in leading the commercialization of innovative therapies and track record of successful strategic growth are precisely what COMPASS needs to advance our goal to bring COMP360 psilocybin therapy to the large number of patients who are not currently served by existing treatments. I look forward to working closely with him as Chairman.”

Goldsmith continued, “Following our end of phase II meeting with FDA, we have submitted our Phase 3 protocols and they are under review. We are pleased with the progress and remain on track to start our phase III clinical program this year. We also continue to expand our clinical development of COMP360 therapy with the commencement of a phase II study in anorexia nervosa, a condition of significant unmet need for which there are no FDA approved pharmacological treatment options.”

Business highlights

COMPASS expands leadership:

• Kabir Nath appointed as Chief Executive Officer
  • Most recently served as Senior Managing Director of global pharmaceuticals at Otsuka Pharmaceutical Co., Ltd. and previously as President and CEO of Otsuka’s North America Pharmaceutical Business

• George Goldsmith remains COMPASS’ Executive Chairman until 31 December 2022 to facilitate the transition, and will remain as active Chairman after that
  • Goldsmith will continue helping shape COMPASS’ leadership in public-private partnerships, advocacy and policy efforts to improve outcomes in mental health at scale

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

• End-of-phase II meeting held with FDA in April 2022, phase III protocols have been submitted to FDA and are under review
• Design of phase III program to be shared at a virtual investor day planned for on 12 October
  • Event will also cover commercial strategy, digital tools, and pipeline including KOL perspectives
• Phase III TRD program expected to commence in fourth quarter 2022

Additional COMP360 development activities:

• Phase II study in anorexia nervosa launched across four world-leading research institutes in the UK and US (King’s College London, Columbia University Medical Center, University of California San Diego School of Medicine and Sheppard Pratt)
• Positive early signals from an exploratory, open-label investigator-initiated study in anorexia nervosa presented in May
• Phase II trial in post-traumatic stress disorder (PTSD) expanded to include Mt. Sinai Hospital in New York City, with internationally recognized PTSD expert Dr. Rachel Yehuda as Principal Investigator, in addition to King’s College London
• Investigator-led study in adults with autism spectrum disorder (ASD) launched, the first ever mechanistic study of psilocybin in autistic adults, co-sponsored by Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London and South London and Maudsley NHS Foundation Trust
• 10 granted patents issued to date covering composition, formulation and method of use
• Investigator-initiated studies underway across numerous additional indications
• Identification of new potential novel drug candidates through the COMPASS Discovery Center
• Strategic partnership formed in March 2022 to launch The Centre for Mental Health Research and Innovation to accelerate research and develop new models of mental healthcare in the UK, in partnership with South London and Maudsley NHS Foundation Trust (SLaM), and IoPPN at King’s College London

Financial highlights

• Net loss for the three months ended 30 June 2022 was $21.0 million, or $0.50 loss per share (including non-cash share-based compensation expense of $3.2 million), compared with $17.5 million or $0.44 loss per share, during the same period in 2021 (including non-cash-share-based compensation expense of $1.9 million).
• Net loss for the six months ended 30 June 2022 was $42.2 million, or $1.00 loss per share (including non-cash share-based compensation expense of $6.3 million), compared with $30.2 million or $0.79 loss per share, during the same period in 2021 (including non-cash-share-based compensation expense of $3.6 million).
• Research and development (R&D) expenses were $15.9 million for the three months ended 30 June 2022, compared with $11.4 million during the same period in 2021. Of this increase, $0.2 million relates to an increase in external development expenses as we continue to investigate COMP360 psilocybin therapy in clinical and pre-clinical trials. A further $1.6 million and $0.9 million were attributable to personnel expenses and non-cash share-based compensation respectively, due to increased headcount. In addition, other expenses increased $1.9 million, which primarily related to an increase in external consulting expenses.
• R&D expenses were $31.3 million for the six months ended 30 June 2022, compared with $18.2 million during the same period in 2021. Of this increase, $5.2 million relates to an increase in external development expenses as we continue to investigate COMP360 psilocybin therapy in clinical and pre-clinical trials. A further $4.3 million and $1.9 million were attributable to personnel expenses and non-cash share-based compensation respectively, due to increased headcount. In addition, other expenses increased $1.7 million primarily related to an increase in external consulting expenses.
• General and administrative (G&A) expenses were $11.3 million for the three months ended 30 June 2022 compared with $8.2 million during the same period in 2021. The increase was attributable to an increase of $0.7 million and $0.4 million in personnel expenses and non-cash share-based compensation respectively, due to increased headcount. There was a further increase of $1.7 million in legal and professional fees and $0.3 million in facilities and other expenses.
• G&A expenses were $21.4 million for the six months ended 30 June 2022 compared with $14.9 million during the same period in 2021. The increase was attributable to an increase of $1.7 million and $0.8 million in personnel expenses and non-cash share-based compensation respectively, due to increased headcount. There was a further increase of $3.2 million in legal and professional fees and $0.8 million in facilities and other expenses.
• Cash and cash equivalents were $207.2 million as of 30 June 2022, compared with $273.2 million as of 31 December 2021.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, COMPASS’ business strategy and goals, the expected timing for finalizing Phase III trial design and launching Phase III trial of COMP360 psilocybin therapy in TRD, the safety or efficacy of its investigational COMP360 psilocybin therapy, including for treatment of TRD or anorexia nervosa, and COMPASS’ expectations regarding its ongoing preclinical work and clinical trials, development efforts and innovation labs. 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 COMPASS’ 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: preclinical and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; our development efforts and our business strategy to set up research facilities and innovation labs will involve significant costs and resources and may be unsuccessful; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’ 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 SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’ current expectations and speak only as of the date hereof.

COMPASS PATHWAYS PLC
Condensed Consolidated Balance Sheets
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(expressed in U.S. Dollars, unless otherwise stated)

COMPASS PATHWAYS PLC
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)