Highlights:
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Business highlights
COMP360 psilocybin therapy in treatment-resistant depression (TRD):
- Phase 3 program on track to commence in 2022
- Program composed of two pivotal trials and one long-term outcomes study
- Pivotal trial 1 (COMP 005): single dose monotherapy, n=378
- Top line data expected end 2024
- Pivotal trial 2 (COMP 006): fixed repeat dose monotherapy, n=568
- Top line data expected mid 2025
- Goal is to provide the evidence needed for FDA approval and payor reimbursement
- Several clinical sites have been initiated
- Pivotal trial 1 (COMP 005): single dose monotherapy, n=378
- Phase 2b trial published in
The New England Journal of Medicine - Phase 2b long-term follow up study complete
- Results supportive of Phase 3 program design
- Results supportive of Phase 3 program design
Additional COMP360 development activities:
- Phase 2 trials in anorexia nervosa ongoing across four world-leading research institutes in the
UK and US (University of California San Diego School of Medicine ,Sheppard Pratt ,King's College London andColumbia University Medical Center ) - Phase 2 trial in post-traumatic stress disorder (PTSD) ongoing at
Mt. Sinai Hospital inNew York City and 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 andSouth 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
Financial highlights
- Net loss for the three months ended
30 September 2022 was$18.4 million , or$0.43 loss per share (including non-cash share-based compensation expense of$3.5 million ), compared with$15.8 million or$0.38 loss per share, during the same period in 2021 (including non-cash-share-based compensation expense of$2.3 million ). - Net loss for the nine months ended
30 September 2022 was$60.6 million , or$1.43 loss per share (including non-cash share-based compensation expense of$9.8 million ), compared with$46.1 million or$1.17 loss per share, during the same period in 2021 (including non-cash-share-based compensation expense of$5.9 million ). - Research and development (R&D) expenses were
$14.0 million for the three months ended30 September 2022 , compared with$12.2 million during the same period in 2021. Of this increase,$1.1 million was attributable to an increase in other expenses, which primarily related to an increase in external consulting expenses. A further$0.8 million and$0.6 million were attributable to personnel expenses and non-cash share-based compensation respectively, due to increased headcount. External development expenses decreased by$0.8 million overall, primarily attributable to decreased clinical trial expenses which are expected to increase substantially in the near future as the Phase 3 program initiates. - R&D expenses were
$45.3 million for the nine months ended30 September 2022 , compared with$30.4 million during the same period in 2021. Of this increase,$5.1 million relates to an increase in personnel expenses, due to increased headcount.$4.5 million relates to an increase in external development expenses as the Company continues to investigate COMP360 psilocybin therapy in clinical and pre-clinical trials. A further$2.7 million was attributable to increased other expenses primarily related to an increase in external consulting expenses. In addition, non-cash share-based compensation increased by$2.5 million , due to increased headcount. - General and administrative (G&A) expenses were
$11.6 million for the three months ended30 September 2022 compared with$9.6 million during the same period in 2021. The increase was attributable to an increase of$0.6 million in legal and professional fees. A further increase of$0.6 million and$0.4 million was attributable to non-cash share-based compensation and personnel expenses respectively, due to increased headcount. There was an additional increase of$0.4 million in facilities and other expenses. - G&A expenses were
$33.0 million for the nine months ended30 September 2022 compared with$24.5 million during the same period in 2021. The increase was attributable to an increase of$3.7 million in legal and professional fees. A further$2.1 million and$1.4 million were attributable to personnel expenses and non-cash share-based compensation respectively, due to increased headcount. There was an additional increase of$1.2 million in facilities and other expenses. - Cash and cash equivalents were
$173.1 million as of30 September 2022 , compared with$273.2 million as of31 December 2021 .
Conference call
The COMPASS Pathways management team will host a conference call at
Please register in advance here to access the call and obtain a local or toll-free phone number and personal pin.
A live webcast of the call will be available on COMPASS Pathway’s website at: Third Quarter 2022 Financial Results.
The webcast will also be available on the Investors section of the COMPASS Pathways website. The webcast will be archived for 30 days.
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).
About COMPASS Pathways
Availability of other information about COMPASS Pathways
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets,
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’s business strategy and goals, the expected timing for starting our Phase 3 clinical program of COMP360 psilocybin therapy in TRD and expected timing for completing our Phase 3 program and providing top-line data, the safety or efficacy of its investigational COMP360 psilocybin therapy, including for treatment of TRD, anorexia nervosa or PTSD, and COMPASS’s 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’s 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’s most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the
Enquiries
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COMPASS PATHWAYS PLC
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share amounts)
(expressed in
2022 | 2021 | |||||
ASSETS | ||||||
CURRENT ASSETS: | ||||||
Cash and cash equivalents | $ | 173,076 | $ | 273,243 | ||
Restricted cash | 155 | 104 | ||||
Prepaid income tax | 465 | 332 | ||||
Prepaid expenses and other current assets | 44,755 | 21,621 | ||||
Total current assets | 218,451 | 295,300 | ||||
NON-CURRENT ASSETS: | ||||||
Investment | 432 | 525 | ||||
Property and equipment, net | 555 | 398 | ||||
Operating lease right-of-use assets | 2,338 | 3,696 | ||||
Deferred tax assets | 2,445 | 766 | ||||
Other assets | 299 | 213 | ||||
Total assets | $ | 224,520 | $ | 300,898 | ||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES: | ||||||
Accounts payable | $ | 19,885 | $ | 2,564 | ||
Accrued expenses and other liabilities | 7,817 | 10,308 | ||||
Operating lease liabilities - current | 1,831 | 2,235 | ||||
Total current liabilities | 29,533 | 15,107 | ||||
NON-CURRENT LIABILITIES | ||||||
Operating lease liabilities - non-current | 425 | 1,379 | ||||
Total liabilities | 29,958 | 16,486 | ||||
Commitments and contingencies | ||||||
SHAREHOLDERS' EQUITY: | ||||||
Ordinary shares, £0.008 par value; 42,554,384 and 42,019,874 shares authorized, issued and outstanding at | 440 | 435 | ||||
Deferred shares, £21,921.504 par value; one share authorized, issued and outstanding at | 28 | 28 | ||||
Additional paid-in capital | 454,957 | 444,750 | ||||
Accumulated other comprehensive (loss)/income | (30,643) | 8,840 | ||||
Accumulated deficit | (230,220) | (169,641) | ||||
Total shareholders' equity | 194,562 | 284,412 | ||||
Total liabilities and shareholders' equity | $ | 224,520 | $ | 300,898 | ||
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)
(expressed in
Three months ended | Nine months ended | |||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||
OPERATING EXPENSES: | ||||||||||||
Research and development | $ | 13,977 | $ | 12,197 | $ | 45,259 | $ | 30,434 | ||||
General and administrative | 11,559 | 9,571 | 32,953 | 24,464 | ||||||||
Total operating expenses | 25,536 | 21,768 | 78,212 | 54,898 | ||||||||
LOSS FROM OPERATIONS: | (25,536) | (21,768) | (78,212) | (54,898) | ||||||||
OTHER INCOME, NET: | ||||||||||||
Other income, net | 3,206 | — | 3,580 | 2 | ||||||||
Foreign exchange gains | 1,096 | 3,364 | 4,387 | 2,171 | ||||||||
Benefit from R&D tax credit | 2,983 | 2,618 | 9,982 | 6,733 | ||||||||
Total other income, net | 7,285 | 5,982 | 17,949 | 8,906 | ||||||||
Loss before income taxes | (18,251) | (15,786) | (60,263) | (45,992) | ||||||||
Income tax expense | (120) | (63) | (316) | (100) | ||||||||
Net loss | (18,371) | (15,849) | (60,579) | (46,092) | ||||||||
Other comprehensive loss: | ||||||||||||
Foreign exchange translation adjustment | (15,156) | (8,401) | (39,483) | (6,768) | ||||||||
Comprehensive loss | (33,527) | (24,250) | (100,062) | (52,860) | ||||||||
Net loss per share attributable to ordinary shareholders—basic and diluted | $ | (0.43) | $ | (0.38) | $ | (1.43) | $ | (1.17) | ||||
Weighted average ordinary shares outstanding—basic and diluted | 42,525,855 | 41,708,220 | 42,377,895 | 39,378,824 |
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