Highlights:
- COMP360 Phase 3 pivotal program ongoing and on track
- CPT® III code for in-person psychedelic therapy support
accepted by the American Medical Association
- Cash position at June 30, 2023 of $148.2 million
- Term loan facility up to $50 million secured
- Conference call today at 8:00 am ET (1:00 pm UK)
|
COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”),
a biotechnology company dedicated to accelerating patient access to
evidence-based innovation in mental health, reported its financial
results for the second quarter 2023 and gave an update on recent
progress across its business.
Kabir Nath, Chief Executive Officer, said, “This
has been another quarter of steady, strong progress across the
business, including the continued execution of our COMP360 phase 3
trials in treatment-resistant depression, important progress in
laying the commercial groundwork for COMP360 with the recent
acceptance by the American Medical Association of a CPT III code to
describe the support services required during administration of
psychedelic drugs, and the FDA’s recently issued guidance on
psychedelic drug development that represents an important
validation of our area of science. Further, the cash received from
the draw down from our debt facility with Hercules and sales of
equity through our ATM program lengthened our cash runway
significantly and allows us to continue to invest in our COMP360
development programs at full speed.”
Business highlights
COMP360 psilocybin therapy in
treatment-resistant depression (TRD):
- Phase 3 program underway, composed
of two pivotal trials with an integrated, long-term outcomes
component
- Pivotal trial 1 (COMP 005): single
dose monotherapy, n=255, topline data expected summer 2024
- Pivotal trial 2 (COMP 006): fixed
repeat dose monotherapy, n=568, topline data expected mid-2025
- Long-term follow up in each trial
will generate data on duration of response and potential effect of
retreatment
- Both phase 3 trials ongoing and on
track
- Current Procedural Terminology
(CPT®) III code language for in-person support services during
psychedelic therapy approved by the American Medical Association
and aligns with expected COMP360 treatment support
requirements.
Additional COMP360 development activities:
- Phase 2 trials in anorexia nervosa
and post-traumatic stress disorder (PTSD) ongoing
- Investigator-initiated study data
in depression in cancer patients following single dose of COMP360
psilocybin presented at ASCO 2023
- Investigator-initiated study
demonstrating the potential for COMP360 psilocybin treatment in
female patients with anorexia nervosa published in Nature
Medicine
- Opinion paper on the definition of
“psychedelic-assisted psychotherapy” using psilocybin published in
American Journal of Psychiatry
- Data from an open-label study that
suggest that the use of selective serotonin reuptake inhibitor
(SSRI) anti-depressants does not interfere with the potential
therapeutic effect of COMP360 published in
Neuropsychopharmacology
Financial highlights
- Cash and cash equivalents were
$148.2 million as of 30 June 2023, compared with $143.2 million as
of 31 December 2022.
- Runway lengthened through term loan
facility and sales of shares under the At the Market (“ATM”)
facility
- Long-term debt was $28.1 million as
of 30 June 2023, compared with $0 million as of 31 December
2022.
- Received $26.9 million in net
proceeds through our ATM facility in second quarter and entered
into a term loan agreement with Hercules Capital,
Inc. (NYSE: HTGC) in June 2023 for up to $50
million, with net proceeds after issuance costs of $28.8 million
received in the second quarter. Total net cash provided by
financing of $55.9 million in the second quarter.
- Net loss for the three months ended
30 June 2023 was $28.3 million, or $0.62 loss per share (including
non-cash share-based compensation expense of $4.6 million),
compared with $21.0 million, or $0.50 loss per share, during the
same period in 2022 (including non-cash-share-based compensation
expense of $3.2 million).
- Net loss for the six months ended
30 June 2023 was $52.5 million, or $1.19 loss per share (including
non-cash share-based compensation expense of $8.6 million),
compared with $42.2 million, or $1.00 loss per share, during the
same period in 2022 (including non-cash-share-based compensation
expense of $6.3 million).
- Research and development (R&D)
expenses were $19.8 million for the three months ended 30 June
2023, compared with $15.9 million during the same period in 2022.
Of this increase, $2.7 million related to an increase in external
development expenses as we continue to investigate COMP360
psilocybin treatment in clinical and pre-clinical trials. A further
$1.8 million and $0.4 million were attributable to personnel
expenses and non-cash share-based compensation respectively, due to
increased headcount. Other expenses decreased by $1.0
million, which primarily related to a decrease in external
consulting expenses.
- R&D expenses were $38.9 million
for the six months ended 30 June 2023, compared with $31.3 million
during the same period in 2022. Of this increase, $4.1 million
related to an increase in external development expenses as we
continue to investigate COMP360 psilocybin treatment in clinical
and pre-clinical trials. A further $3.0 million and $0.8 million
were attributable to personnel expenses and non-cash share-based
compensation respectively, due to increased headcount. Other
expenses decreased by $0.3 million, which primarily related to a
decrease in external consulting expenses.
- General and administrative
(G&A) expenses were $12.8 million for the three months ended 30
June 2023, compared with $11.3 million during the same period in
2022. The increase was attributable to an increase of $1.0 million
and $0.5 million in non-cash share-based compensation and personnel
expenses respectively, due to increased headcount. There was a
further increase of less than $0.1 million in facilities and other
expenses and a decrease of $0.1 million in legal and professional
fees.
- G&A expenses were $25.6 million
for the six months ended 30 June 2023, compared with $21.4 million
during the same period in 2022. The increase was attributable to an
increase of $2.8 million and $1.5 million in personnel expenses and
non-cash share-based compensation respectively, due to increased
headcount. There was a further increase of $0.9 million in
facilities and other expenses and a decrease of $1.0 million in
legal and professional fees.
Financial Guidance
Third quarter 2023 net cash (provided by)/used
in operating activities is expected to be in the range of ($2
million) to $18 million. This range includes the amount receivable
in respect of the R&D tax credit in the UK, the timing for
which is uncertain. We expect the full-year 2023 net cash used in
operating activities to be in the range of $80 million to $90
million.
Conference call
The COMPASS Pathways management team will host a
conference call at 8.00am ET (1:00pm UK) on August [3], 2023.
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: Second
Quarter 2023 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
PathwaysCOMPASS Pathways plc (Nasdaq: CMPS) is a mental
health care company dedicated to accelerating patient access to
evidence-based innovation in mental health. Our focus is on
improving the lives of those who are suffering with mental health
challenges and who are not helped by current treatments. We are
pioneering the development of a new model of psilocybin treatment,
in which our proprietary formulation of synthetic psilocybin,
COMP360, is administered in conjunction with psychological support.
COMP360 has been designated a Breakthrough Therapy by the U.S. Food
and Drug Administration (FDA) and has received Innovative Licensing
and Access Pathway (ILAP) designation in the UK for
treatment-resistant depression (TRD). We have commenced a phase 3
clinical program of COMP 360 psilocybin treatment in TRD, the
largest randomised, controlled, double-blind psilocybin treatment
clinical program ever conducted. Previously, we completed a phase
2b study with top line data showing a statistically significant
(p<0.001) and clinically relevant improvement in depressive
symptom severity after three weeks for patients who received a
single high dose of COMP360 psilocybin with psychological support.
We are also conducting phase 2 clinical studies of COMP360
psilocybin treatment for post-traumatic stress disorder (PTSD) and
anorexia nervosa. COMPASS is headquartered in London, UK, with
offices in New York and San Francisco in the United States. Our
vision is a world of mental wellbeing. www.compasspathways.com
Availability of other information about COMPASS
PathwaysInvestors 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,
US Securities and Exchange Commission filings, press releases,
public conference calls and webcasts. The information that we post
on these channels and websites could be deemed to be material
information. As a result, we encourage investors, the media, and
others interested in us to review the information that is posted on
these channels, including the investor relations website, on a
regular basis. This list of channels may be updated from time to
time on our investor relations website and may include additional
social media channels. The contents of our website or these
channels, or any other website that may be accessed from our
website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933.
Forward-looking statementsThis 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
financial guidance, COMPASS’s business strategy and goals, its
expectations and projections about the company’s future cash needs
and financial results, COMPASS’s plans and expectations regarding
its phase 3 trials in TRD, including its expectations that the
trials are on track and the period during which the results of the
Phase 3 trials will become available, the potential for these Phase
3 trials or other trials to support regulatory filings and
approvals, the safety or efficacy of its investigational COMP360
psilocybin treatment, including for treatment of TRD, anorexia
nervosa, PTSD and depression, COMPASS’s expectations regarding the
potential impact of the CPT III codes on reimbursement for and
access to COMP360 psilocybin treatment, if FDA approval is obtained
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: we will require substantial additional
funding to achieve our business goals, including to repay the term
loan facility, and if we are unable to obtain this funding when
needed and on acceptable terms, we could be forced to delay, limit
or terminate our product development efforts; the availability of
future tranches under the term loan facility is dependent, in part,
on the approval of the lender, achievement of certain milestones
and other factors; clinical development is lengthy and outcomes are
uncertain, and therefore our clinical trials may be delayed or
terminated; our efforts to obtain marketing approval from the
applicable regulatory authorities in any jurisdiction for COMP360
or any of future product candidates may be unsuccessful; our
development efforts and our business strategy to set up research
facilities and innovation labs involves significant costs and
resources and may be unsuccessful; and our efforts to obtain
coverage and reimbursement for our investigational COMP360
psilocybin treatment, if approved, 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
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’s current expectations and speak only as of the
date hereof.
EnquiriesMedia: Amy Lawrence,
amy@compasspathways.com, +44 7813 777 919 Investors: Stephen
Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
COMPASS PATHWAYS
PLCCondensed Consolidated Balance
Sheets(unaudited)(in thousands, except share and per share
amounts)(expressed in U.S. Dollars, unless otherwise stated)
|
June 30, |
|
December 31, |
|
2023 |
|
2022 |
ASSETS |
|
|
|
CURRENT ASSETS: |
|
|
|
Cash and cash
equivalents |
$148,234 |
|
$143,206 |
Restricted
cash |
251 |
|
175 |
Prepaid income
tax |
— |
|
575 |
Prepaid expenses and other current
assets |
45,116 |
|
47,695 |
Total current
assets |
193,601 |
|
191,651 |
NON-CURRENT ASSETS: |
|
|
|
Investment |
469 |
|
469 |
Property and equipment,
net |
482 |
|
617 |
Operating lease right-of-use
assets |
4,784 |
|
2,006 |
Deferred tax
assets |
3,054 |
|
2,224 |
Long-term prepaid expenses and
other assets |
7,444 |
|
327 |
Total assets |
$209,834 |
|
$197,294 |
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
CURRENT LIABILITIES: |
|
|
|
Accounts
payable |
$1,982 |
|
$4,761 |
Accrued expenses and other
liabilities |
8,617 |
|
9,325 |
Operating lease liabilities -
current |
2,176 |
|
1,510 |
Total current
liabilities |
12,775 |
|
15,596 |
NON-CURRENT LIABILITIES |
|
|
|
Long-term debt |
28,124 |
|
— |
Operating lease liabilities -
non-current |
2,539 |
|
418 |
Total
liabilities |
$43,438 |
|
$16,014 |
SHAREHOLDERS' EQUITY: |
|
|
|
Ordinary shares, £0.008 par value; 45,760,250 and 42,631,794 shares
authorized, issued and outstanding at June 30, 2023 and December
31, 2022,
respectively |
471 |
|
440 |
Deferred shares, £21,921.504 par value; nil and one share
authorized, issued and outstanding at June 30, 2023 and December
31, 2022,
respectively |
— |
|
28 |
Additional paid-in
capital |
496,342 |
|
458,825 |
Accumulated other
comprehensive
(loss) |
(16,728) |
|
(16,867) |
Accumulated
deficit |
(313,689) |
|
(261,146) |
Total shareholders'
equity |
166,396 |
|
181,280 |
Total liabilities and shareholders'
equity |
$209,834 |
|
$197,294 |
|
|
|
|
COMPASS PATHWAYS
PLCCondensed Consolidated Statements of Operations
and Comprehensive Loss(unaudited)(in thousands, except
share and per share amounts)(expressed in U.S. Dollars, unless
otherwise stated)
|
Three months ended |
|
Six months ended |
|
June 30, |
|
June 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
OPERATING EXPENSES: |
|
|
|
|
|
|
|
Research and
development |
$19,818 |
|
$15,920 |
|
$38,853 |
|
$31,282 |
General and
administrative |
12,846 |
|
11,336 |
|
25,599 |
|
21,394 |
Total operating
expenses |
32,664 |
|
27,256 |
|
64,452 |
|
52,676 |
LOSS FROM
OPERATIONS: |
(32,664) |
|
(27,256) |
|
(64,452) |
|
(52,676) |
OTHER INCOME, NET: |
|
|
|
|
|
|
|
Other income,
net |
627 |
|
240 |
|
1,336 |
|
374 |
Foreign exchange
gains |
1,376 |
|
1,958 |
|
4,061 |
|
3,291 |
Benefit from R&D tax
credit |
2,520 |
|
4,077 |
|
6,836 |
|
6,999 |
Total other income,
net |
4,523 |
|
6,275 |
|
12,233 |
|
10,664 |
Loss before income
taxes |
(28,141) |
|
(20,981) |
|
(52,219) |
|
(42,012) |
Income tax
expense |
(194) |
|
(56) |
|
(324) |
|
(196) |
Net
loss |
(28,335) |
|
(21,037) |
|
(52,543) |
|
(42,208) |
Other comprehensive (loss)
income: |
|
|
|
|
|
|
|
Foreign exchange translation
adjustment |
717 |
|
(17,134) |
|
139 |
|
(24,327) |
Comprehensive
loss |
(27,618) |
|
(38,171) |
|
(52,404) |
|
(66,535) |
Net loss per share
attributable to ordinary shareholders—basic and
diluted |
$(0.62) |
|
$(0.50) |
|
$(1.19) |
|
$(1.00) |
Weighted average ordinary
shares outstanding—basic and
diluted |
45,565,991 |
|
42,474,987 |
|
44,153,772 |
|
42,110,161 |
|
|
|
|
|
|
|
|
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