COMPASS Pathways plc announces financial results and business highlights for the third quarter 2021

By Louise Sommerfeld On Nov 9, 2021

Highlights:

Positive topline results from phase IIb COMP360 psilocybin therapy trial for treatment-resistant depression; rapid and sustained response for patients receiving a single 25mg dose of COMP360 psilocybin with psychological support
Launch of phase II study of COMP360 psilocybin therapy for PTSD
Positive signals from Maryland Oncology Hematology open-label investigator initiated study of COMP360 psilocybin therapy for depression in cancer
Acquisition of IP portfolio of novel psychedelic compounds and prodrugs
Hamilton Morris appointed full-time consultant
New US composition patent granted for crystalline psilocybin
Conference call today at 1:00pm UK (8:00am ET)

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 third quarter 2021 and gave an update on recent progress across its business.

With the positive topline results from our COMP360 psilocybin therapy phase IIb trial, we are one step closer to potentially providing a much-needed therapeutic option to patients suffering with treatment-resistant depression. At the same time, we are making great progress in broadening our pipeline – we are beginning a phase II COMP360 psilocybin therapy trial for PTSD, and we have acquired a large portfolio of new compounds and IP, working with Matthias Grill PhD. Our goal remains the same – to transform mental health care and bring options to the millions of patients who currently don’t have many.
George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways

Business highlights

Positive topline results from groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD); data shared in separate press release published today
Continued investment in the expansion of COMPASS portfolio with addition of phase II trial of COMP360 psilocybin therapy in post-traumatic stress disorder (PTSD)
- 20 patient, fixed dose, open-label trial to begin at The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London
Promising data from open-label investigator-initiated study of COMP360 psilocybin therapy for depression in cancer, conducted and reported by Maryland Oncology Hematology at the Aquilino Cancer Center (Rockville, MD)
- Showed feasibility of simultaneous psilocybin administration in small groups, with 1:1 support
- Remission in major depression symptoms for 15 of the 30 patients, sustained for eight-week follow-up
- COMP360 psilocybin found to be generally well-tolerated with no treatment-related serious adverse events
Acquisition of intellectual property (IP) portfolio including patent applications covering a variety of psychedelic and empathogenic substances
- IP developed with Dr Matthias Grill, founder and CEO of MiHKAL GmbH in Basel, Switzerland
- Working with Dr Grill on exclusive research project to develop new product candidates
Hamilton Morris, research scientist and filmmaker, appointed full-time consultant
- Researching new psychedelic compounds that could be developed into therapies in areas of unmet mental health need
New US patent granted
- Claims covering alternative crystalline psilocybin not used in COMP360
- Portfolio of nine granted patents, including four in the US, two in the UK, one in Germany, two in Hong Kong

Financial highlights

Net loss for the three months ended 30 September 2021 was $15.8 million or $0.38 loss per share (after including non-cash share-based compensation expense of $2.3 million), compared with $16.7 million or $1.30 loss per share during the same period in 2020 (after including non-cash-share-based compensation expense of $5.2 million).
Net loss for the nine months ended 30 September 2021 was $46.1 million, or $1.17 loss per share (after including non-cash share-based compensation expense of $5.9 million), compared with $41.5 million, or $3.90 loss per share, during the same period in 2020 (after including non-cash share-based compensation expense of $16.6 million).
Research & development (R&D) expenses were $12.2 million for the three months ended 30 September 2021, compared with $6.9 million during the same period in 2020. Of this increase, $6.2 million reflected increased development activities, including hiring additional staff, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. There was a reduction of $0.9 million in non-cash share-based compensation expense compared with the same period in the prior year.
R&D expenses were $30.4 million for the nine months ended 30 September 2021, compared with $18.8 million during the same period in 2020. Of this increase, $14.3 million reflected increased development activities, including hiring additional staff, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. There was a reduction of $2.7 million in non-cash share-based compensation expense compared with the same period in the prior year.
G&A expenses were $9.6 million for the three months ended 30 September 2021, compared with $6.6 million during the same period in 2020. The increase was attributable to a reduction of $2.0 million in non-cash share-based compensation, offset against an increase of $2.5 million, $0.7 million and $1.8 million, respectively, in personnel expenses, legal and professional fees, and facilities and other expenses.
G&A expenses were $24.5 million for the nine months ended 30 September 2021, compared with $21.1 million during the same period in 2020. The increase was attributable to a reduction of $8.0 million in non-cash share-based compensation, offset against an increase of $5.8 million, $0.8 million and $4.9 million, respectively, in personnel expenses, legal and professional fees, and facilities and other expenses.
Cash and cash equivalents were $294.0 million as of 30 September 2021, compared with $196.5 million at 30 September 2020.

Conference call

The COMPASS Pathways management team will host a conference call at 1.00pm UK (8.00am ET) on 9 November 2021. The call can be accessed by dialing (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 34908054.

The call will be accompanied by a presentation which will be available on the COMPASS Pathways website (ir.compasspathways.com). The call will also be webcast on the website and archived for 30 days.

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