Compass Pathways plc (Nasdaq: CMPS) (“Compass”), a biotechnology
company dedicated to accelerating access to evidence-based
innovation in mental health, today reported its financial results
for the second quarter 2024 and an update on recent business
progress.
“As we continue to advance our phase 3 program in
treatment-resistant depression, we are pleased to expand the
breadth and depth of experience across our executive and leadership
teams with the additions of Lori Englebert as Chief Commercial
Officer and Gino Santini as Chairman,” said Kabir Nath, Chief
Executive Officer, Compass Pathways. “We thank David Norton for his
service as interim Chairman over the last several months.”
“We were also pleased to share positive results
from our phase 2 post-traumatic stress disorder study in the second
quarter and we are looking forward to data from our phase 3 pivotal
program in treatment-resistant depression, expected later this
year,” said Mr. Nath.
Business highlights
COMP360 psilocybin treatment in
treatment-resistant depressionThe phase 3 clinical program
of COMP360 psilocybin treatment in treatment-resistant depression
is the largest randomized, controlled, double-blind psilocybin
treatment clinical program ever conducted. Top-line pivotal COMP005
trial data is expected in the fourth quarter 2024 and COMP006 trial
top-line primary endpoint is expected mid-2025.
COMP360 psilocybin treatment in
post-traumatic stress disorderCompass announced data in
the second quarter from an open-label phase 2 study evaluating the
safety and tolerability of investigational COMP360 psilocybin
treatment in 22 patients with post-traumatic stress disorder.
Participants received a single 25mg dose of psilocybin along with
psychological support, provided by a licensed medical professional,
to ensure patient safety. Administration was well tolerated with no
serious adverse events reported. Additional observations included
meaningful and sustained symptom improvement from baseline in mean
CAPS-5 total score, a measure of disease severity, and in Sheehan
Disability Scale score, a measure of functional impairment in daily
life. There were high and sustained rates of response and remission
relative to baseline, with early onset of symptom improvement,
accompanied by increasing functional improvement at 4 and 12 weeks.
No patients withdrew from the study and no patients returned to
antidepressant medication treatment during the trial. Based on
results, Compass is exploring the optimal path forward for
PTSD.
Leadership updatesGino Santini
will join the Board of Directors as Chairman effective September 3,
2024. Mr. Santini brings more than a decade of board leadership and
governance expertise in both public and private global
corporations. He currently serves as lead independent director for
Collegium Pharmaceuticals (NASDAQ: COLL) and has served as an
advisor and board director to US and European venture capital,
pharmaceutical, and biotechnology companies since 2011. During his
director tenure across more than ten boards, including prior board
service at Horizon, Intercept Pharmaceuticals and AMAG
Pharmaceuticals, Mr. Santini has honed his governance experience as
Chairman, Lead Independent Director, and in multiple Committee
chair roles. Throughout his nearly three decades at Eli Lilly and
Company, he played a leading role in several M&A transactions
and led US operations, corporate strategy and business
development.
David Norton, who has been serving as Interim
Chairman of the Board, will continue to be a member of the
Board.
Lori Englebert joined Compass Pathways as Chief
Commercial Officer in July. In her prior role at Axsome
Therapeutics, she spent nearly five years as a member of the
executive team serving as head of commercial and business
development and most recently as head of product strategy. Compass
previously announced the appointment of Michael Gold as Chief
Research and Development Officer. Dr. Gold took up his post in the
second quarter.
Financial highlights
- Net loss for the
three months ended June 30, 2024, was $38.1 million, or $0.56 loss
per share (including non-cash share-based compensation expense of
$4.9 million), compared with $28.3 million, or $0.62 loss per
share, during the same period in 2023 (including
non-cash-share-based compensation expense of $4.6
million).
- Net loss for the
six months ended June 30, 2024, was $73.3 million, or $1.11 loss
per share (including non-cash share-based compensation expense of
$10.1 million), compared with $52.5 million, or $1.19 loss per
share, during the same period in 2023 (including
non-cash-share-based compensation expense of $8.6
million).
- Research and
development expenses were $29.1 million for the three months ended
June 30, 2024, compared with $19.8 million during the same period
in 2023. The increase was primarily attributable to development
expenses, associated with advancing our late-stage COMP360 phase 3
clinical trials, and increased personnel expenses due to increased
R&D headcount.
- Research and
development expenses were $54.0 million for the six months ended
June 30, 2024, compared with $38.9 million during the same period
in 2023. The increase was primarily attributable to development
expenses, associated with advancing our late-stage COMP360 phase 3
clinical trials, and increased personnel expenses due to increased
R&D headcount.
- General and
administrative expenses were $14.3 million for the three months
ended June 30, 2024, compared with $12.8 million during the same
period in 2023. The increase was primarily attributable to
increased personnel expenses due to increased headcount supporting
our corporate functions.
- General and
administrative expenses were $27.9 million for the six months ended
June 30, 2024, compared with $25.6 million during the same period
in 2023. The increase was primarily attributable to increased
personnel expenses due to increased headcount supporting our
corporate functions and increased non-cash share-based
compensation.
- Cash and cash
equivalents were $228.6 million as of June 30, 2024, compared with
$220.2 million as of December 31, 2023.
- Long term debt
was $29.4 million as of June 30, 2024, compared with $28.8 million
as of December 31, 2023.
Financial GuidanceThird quarter
2024 net cash used in operating activities is expected to be in the
range of $32 million to $38 million. The full-year 2024 net cash
used in operating activities is expected to be in the range of $110
million to $130 million, which assumes that the 2023 R&D tax
credit will be received this year. The cash position at June 30,
2024, is expected to be sufficient to fund operating expenses and
capital expenditure requirements into 2026.
Conference callThe management team
will host a conference call at 8:00 am ET (1:00 pm UK) on August 1,
2024. A live webcast of the call will be available on the Compass
Pathways website at Second Quarter 2024 Financial Results.The
webcast will also be on the Investors section of the Compass
Pathways website for 30 days.
About Compass PathwaysCompass
Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to
accelerating patient access to evidence-based innovation in mental
health. Our focus is on improving the lives of those who are living
with mental health challenges and who are not helped by existing
standards of care. 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 Breakthrough Therapy designation
from the US 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
COMP360 psilocybin treatment in TRD, the largest randomized,
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 25mg dose of
COMP360 psilocybin with psychological support. We have completed an
open label phase 2 study of COMP360 psilocybin treatment for
post-traumatic stress disorder (PTSD), and we are currently
conducting a phase 2 clinical study in anorexia nervosa.
Compass is headquartered in London, UK, with
offices in New York and San Francisco in the US. Our vision is a
world of mental wellbeing.
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”, “will”, “could”, “would”,
“expect”, “intend”, “plan”, “anticipate”, “believe”, “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, our financial
guidance; our business strategy and goals, our expectations and
projections about the company’s future cash needs and financial
results; our plans and expectations regarding our phase 3 trials in
TRD, including our expectations regarding the time periods during
which the results of the two Phase 3 trials will become available;
the potential for the pivotal phase 3 program in TRD, any future
trials in PTSD, or other trials to support regulatory filings and
approvals; our expectations regarding the safety or efficacy of our
investigational COMP360 psilocybin treatment, including as a
treatment for treatment of TRD, PTSD, and anorexia nervosa; our
expectations regarding the benefits of our investigational COMP360
psilocybin treatment; and our plans, expectations and ability to
achieve our goals related to the research collaboration agreements.
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 our 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 clinical trials and research and 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 phase 3 clinical trials in TRD and our other clinical trials
may be delayed or terminated; the results of early-stage clinical
trials of our investigational COMP360 psilocybin treatment may not
be predictive of the results of later stage clinical trials; 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; the risk that our research
collaborations will not continue or will not be successful; 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 our 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. Except as
required by law, we disclaim 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 our current expectations and speak only as of the date
hereof.
EnquiriesMedia: Sally Bain,
sally.bain@compasspathways.com, + 1 781 458 0443Investors: 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, |
|
|
2024 |
|
|
2023 |
ASSETS |
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
$ |
228,628 |
|
$ |
220,198 |
Restricted cash |
|
389 |
|
|
440 |
Prepaid expenses and other current assets |
|
36,076 |
|
|
40,658 |
Total current assets |
|
265,093 |
|
|
261,296 |
NON-CURRENT ASSETS: |
|
|
|
|
|
Operating lease right-of-use
assets |
|
3,179 |
|
|
4,306 |
Deferred tax assets |
|
4,022 |
|
|
3,336 |
Long-term prepaid expenses and
other assets |
|
6,239 |
|
|
7,049 |
Total assets |
$ |
278,533 |
|
$ |
275,987 |
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
Accounts payable |
$ |
8,195 |
|
$ |
5,892 |
Accrued expenses and other liabilities |
|
11,447 |
|
|
11,301 |
Operating lease liabilities - current |
|
2,385 |
|
|
2,411 |
Total current liabilities |
|
22,027 |
|
|
19,604 |
NON-CURRENT LIABILITIES |
|
|
|
|
|
Long-term debt |
|
29,434 |
|
|
28,757 |
Operating lease liabilities - non-current |
|
799 |
|
|
1,882 |
Total liabilities |
$ |
52,260 |
|
$ |
50,243 |
SHAREHOLDERS' EQUITY: |
|
|
|
|
|
Ordinary shares, £0.008 par value; 68,387,469 and 61,943,471 shares
authorized, issued and outstanding at June 30, 2024 and December
31, 2023, respectively |
|
699 |
|
|
635 |
Additional paid-in
capital |
|
695,353 |
|
|
621,645 |
Accumulated other
comprehensive loss |
|
(16,881) |
|
|
(16,926) |
Accumulated deficit |
|
(452,898) |
|
|
(379,610) |
Total shareholders' equity |
|
226,273 |
|
|
225,744 |
Total liabilities and shareholders' equity |
$ |
278,533 |
|
$ |
275,987 |
|
|
|
|
|
|
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 June 30, |
|
Six months ended June 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
OPERATING EXPENSES: |
|
|
|
|
|
|
|
Research and development |
$ |
29,069 |
|
$ |
19,818 |
|
$ |
53,970 |
|
$ |
38,853 |
General and administrative |
14,253 |
|
12,846 |
|
27,925 |
|
25,599 |
Total operating expenses |
43,322 |
|
32,664 |
|
81,895 |
|
64,452 |
Loss from operations: |
(43,322) |
|
(32,664) |
|
(81,895) |
|
(64,452) |
OTHER INCOME, NET: |
|
|
|
|
|
|
|
Benefit from R&D tax credit |
3,709 |
|
2,520 |
|
6,810 |
|
6,836 |
Interest income |
2,408 |
|
638 |
|
4,668 |
|
1,342 |
Interest expense |
(1,112) |
|
— |
|
(2,210) |
|
— |
Foreign exchange gains (losses) |
225 |
|
1,376 |
|
(558) |
|
4,061 |
Other income (expense), net |
167 |
|
(11) |
|
295 |
|
(6) |
Total other income, net |
5,397 |
|
4,523 |
|
9,005 |
|
12,233 |
Loss before income taxes |
(37,925) |
|
(28,141) |
|
(72,890) |
|
(52,219) |
Income tax expense |
(176) |
|
(194) |
|
(398) |
|
(324) |
Net loss |
$ |
(38,101) |
|
$ |
(28,335) |
|
$ |
(73,288) |
|
$ |
(52,543) |
|
|
|
|
|
|
|
|
Net loss per share
attributable to ordinary shareholders—basic and diluted |
$ |
(0.56) |
|
$ |
(0.62) |
|
$ |
(1.11) |
|
$ |
(1.19) |
Weighted average ordinary
shares outstanding—basic and diluted |
68,371,139 |
|
45,565,991 |
|
66,296,658 |
|
44,153,772 |
|
|
|
|
|
|
|
|
Net loss |
$ |
(38,101) |
|
$ |
(28,335) |
|
$ |
(73,288) |
|
$ |
(52,543) |
Other comprehensive loss: |
|
|
|
|
|
|
|
Foreign exchange translation adjustment |
81 |
|
717 |
|
45 |
|
139 |
Comprehensive loss |
$ |
(38,020) |
|
$ |
(27,618) |
|
$ |
(73,243) |
|
$ |
(52,404) |
|
|
|
|
|
|
|
|
Grafico Azioni COMPASS Pathways (NASDAQ:CMPS)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni COMPASS Pathways (NASDAQ:CMPS)
Storico
Da Set 2023 a Set 2024