COMPASS Pathways Announces Fourth Quarter and Year-End 2022 Financial Results and Business Highlights

“During this past quarter, we commenced our COMP360 phase 3 pivotal program in treatment-resistant depression, a significant milestone for our area of science as these are the first ever phase 3 trials of psilocybin. We have also announced important updates to this program that accelerate the placebo-controlled trial pivotal data read out and streamline the long-term follow up as an integrated component of the pivotal trials. We are confident that this phase 3 program should generate the evidence to support a regulatory filing and to support broad patient access through integration into healthcare systems.”

Kabir Nath, Chief Executive Officer

• Phase 3 program underway, program composed of two pivotal trials with an integrated long-term outcomes component
  • Pivotal trial 1 (COMP 005): single dose monotherapy, n=255, top line data expected summer 2024
    • Updates to 005 accelerate data read out
  • Pivotal trial 2 (COMP 006): fixed repeat dose monotherapy, n=568, top line data expected mid-2025
  • Long term outcome component includes a single 25 milligram retreatment option for all qualifying patients
• Phase 2b trial published in The New England Journal of Medicine

• Phase 2 trials in anorexia nervosa and post-traumatic stress disorder (PTSD) ongoing
• Investigator-initiated studies across numerous additional indications including:
  • Bipolar disorder type II: data presented at ACNP showing treatment was well tolerated with 12 of 14 patients in remission at three months following a single 25 milligram administration of COMP 360 psilocybin therapy, and no subject having manic or hypomanic symptoms or an increase in suicidal ideation
  • Anorexia nervosa: 6 of 10 participants in remission from Eating Disorder Psychopathology following a single 25 milligram administration of COMP 360, treatment was well tolerated and 9 of 10 participants endorsed the experience as meaningful and therapeutic; data presented at the Society of Biological Psychiatry annual meeting in April 2022.
  • Major depressive disorder in adults: data from the University of Zurich published in The Lancet in December. This randomized blinded study enrolled 52 patients, comparing a weight-based dose of COMP360 to true placebo, and demonstrated compelling efficacy results with no new safety signal.

• Net loss for the year ended 31 December 2022 was $91.5 million, or $2.16 loss per share (including non-cash share-based compensation expense of $13.1 million), compared with $71.7 million, or $1.79 loss per share, during the same period in 2021 (including non-cash share-based compensation expense of $8.6 million).
• Net loss for the three months ended 31 December 2022 was $30.9 million, or $0.73 loss per share (including non-cash share-based compensation expense of $3.3 million), compared with $25.7 million, or $0.61 loss per share, during the same period in 2021 (including non-cash share-based compensation expense of $2.8 million).
• Research and development (R&D) expenses were $65.1 million for the year ended 31 December 2022, compared with $44.0 million during the same period in 2021. Of this increase, $6.7 million relates to an increase in external development expenses as the Company continues to investigate COMP360 psilocybin therapy in clinical and pre-clinical trials. $6.1 million relates to an increase in personnel expenses, due to increased headcount. A further $5.4 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 $2.8 million, due to increased headcount.
• R&D expenses were $19.8 million for the three months ended 31 December 2022, compared with $13.6 million during the same period in 2021. Of this increase, $2.7 million was attributable to an increase in other expenses, which primarily related to an increase in external consulting expenses. A further $2.3 million was attributable to an increase in external development expenses. Personnel expenses and non-cash share-based compensation increased by $1.0 million and $0.2 million respectively.
• General and administrative (G&A) expenses were $45.4 million for the year ended 31 December 2022, compared with $39.2 million during the same period in 2021. The increase was attributable to an increase of $3.2 million in personnel expenses, due to increased headcount. A further $2.8 million and $1.7 million were attributable to legal and professional fees and non-cash share-based compensation respectively. The increases were offset by a decrease of $1.5 million in facilities and other expenses.
• G&A expenses were $12.4 million for the three months ended 31 December 2022, compared with $14.7 million during the same period in 2021. The decrease was attributable to a decrease of $2.6 million and $1.0 million in facilities and other expenses and legal and professional fees respectively. This was partially offset by an increase of $1.0 million in personnel expenses and an increase of $0.3 million in non-cash share-based compensation expense, due to increased headcount.
• Cash and cash equivalents were $143.2 million as of 31 December 2022, compared with $273.2 million as of 31 December 2021.
  

• First quarter 2023 net cash used in operating activities is expected to be in the range of $24 million to $32 million and the full-year 2023 to be in the range of $85 million to $110 million.
  

	December 31,
	2022		2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$        143,206		$        273,243
Restricted cash	175		104
Prepaid income tax	575		332
Prepaid expenses and other current assets	47,695		21,621
Total current assets	191,651		295,300
NON-CURRENT ASSETS:
Investment	469		525
Property and equipment, net	617		398
Operating lease right-of-use assets	2,006		3,696
Deferred tax assets	2,224		766
Other assets	327		213
Total assets	$        197,294		$        300,898
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable	$            4,761		$            2,564
Accrued expenses and other liabilities	9,325		10,308
Operating lease liabilities – current	1,510		2,235
Total current liabilities	15,596		15,107
NON-CURRENT LIABILITIES
Operating lease liabilities – non-current	418		1,379
Total liabilities	16,014		16,486
Commitments and contingencies (Note 15)
SHAREHOLDERS’ EQUITY:
Ordinary shares, £0.008 par value; 42,631,794 and 42,019,874 shares authorized, issued and outstanding at December 31, 2022 and 2021, respectively	440		435
Deferred shares, £21,921.504 par value; one share authorized, issued and outstanding at December 31, 2022 and 2021	28		28
Additional paid-in capital	458,825		444,750
Accumulated other comprehensive (loss)/income	(16,867)		8,840
Accumulated deficit	(261,146)		(169,641)
Total shareholders’ equity	181,280		284,412
Total liabilities and shareholders’ equity	$        197,294		$        300,898

	Three Months Ended December 31,		Twelve Months Ended December 31,
	2022		2021		2022		2021
OPERATING EXPENSES:
Research and development	$19,794		$13,593		$65,053		$44,027
General and administrative	12,397		14,730		45,350		39,194
Total operating expenses	32,171		28,323		110,403		83,221
LOSS FROM OPERATIONS:	(32,191)		(28,323)		(110,403)		(83,221)
OTHER INCOME (EXPENSE), NET:
Other income, net	481		38		4,061		40
Foreign exchange gains (losses)	(3,566)		(181)		821		1,990
Benefit from R&D tax credit	4,442		2,915		14,424		9,648
Total other income (expense), net	1,357		2,772		19,306		11,678
Loss before income taxes	(30,834)		(25,551)		(91,097)		(71,543)
Income tax expense	(92)		(99)		(408)		(199)
Net loss	(30,926)		(25,650)		(91,505)		(71,742)
Other comprehensive loss:
Foreign exchange translation adjustment	13,776		1,076		(25,707)		(5,745)
Comprehensive loss	(17,150)		(24,574)		(117,212)		(77,487)
Net loss per share attributable to ordinary shareholders—basic and diluted	$(0.73)		$(0.61)		$(2.16)		$(1.79)
Weighted average ordinary shares outstanding—basic and diluted	42,436,292		39,997,587		42,436,292		39,997,587