· Third quarter and post-period
highlights:
- Completed upsized initial public
offering (IPO) on Nasdaq, raising $146.6 million
- Continued to progress phase IIb
clinical trial of COMP360 psilocybin therapy for
treatment-resistant depression
- Strengthened board and leadership
team with appointments of Linda McGoldrick as non-Executive
Director; Greg Ryslik as Senior Vice President, Data Science,
Machine Learning and Digital Health Research; and Stephen Schultz
as Senior Vice President, Investor Relations
- Established Drug Discovery Center
with the University of the Sciences in Philadelphia, PA
· Conference call today at 1.00pm GMT (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 of 2020 and gave an update on recent progress
across its business.
George Goldsmith, Chairman, CEO and Co-founder,
COMPASS Pathways, said, “This has been a significant quarter, with
an IPO that gives us the funds needed to advance our mission and
transform mental health care. Recent hires for the company build
further important expertise within our strong leadership team,
including in data science and digital health, which will be core to
the future of mental health care. We remain fully focused on
execution of our phase IIb trial investigating our COMP360
psilocybin therapy for treatment-resistant depression and, with
scientific partners in our recently established Drug Discovery
Center, are also evaluating the potential of early stage compounds
to address mental health challenges.”
Corporate
highlights
In September 2020, we completed our IPO of
8,625,000 American Depositary Shares (ADSs) representing 8,625,000
ordinary shares at a price of $17.00 per ADS. This
included 1,125,000 additional ADSs issued upon the exercise in full
by the underwriters of their option to purchase additional ADSs.
The total gross proceeds from the offering were $146.6
million. All ADSs sold in the offering were offered by COMPASS. The
ADSs began trading on the Nasdaq Global Select Market on
18 September 2020.
Business
highlights
We have continued to make steady progress with
our phase IIb clinical trial of COMP360 psilocybin therapy for
treatment-resistant depression. We are opening a new trial site in
Berlin, Germany, this month, bringing our trial to 21 sites in 10
countries. While the COVID-19 pandemic has impacted our trial, our
plan to report data from this trial in late 2021 remains unchanged.
We are working closely with our trial sites to carefully assess the
ongoing COVID-19 situation and will always put the safety of
patients and our teams above everything else.
Our team has continued to expand and we have
been pleased to welcome several new colleagues to our leadership
team during the quarter and post-period. Linda McGoldrick joined
our board of directors in September 2020, bringing healthcare and
life sciences experience from a range of public and private
companies, and non-profit organisations, including Financial Health
Associates International, Zillion Inc, Veos plc, and Kaiser
Permanente International. In 2018, Linda was appointed by the
Governor of Massachusetts to serve on the state’s Health
Information Technology Commission. Greg Ryslik PhD joined us on 9
November 2020 as Senior Vice President, Data Science, Machine
Learning and Digital Health Research, and Stephen Schultz will join
us on 1 December 2020 as Senior Vice President, Investor Relations.
Greg is a data scientist and AI (artificial intelligence)
executive; he is an instructor at Stanford Continuing Studies and
has held senior positions at Mindstrong and at Tesla Inc. Stephen
has more than 30 years’ experience in investor relations and joins
us from GW Pharmaceuticals; he has previously held senior roles at
Amarin Corporation, Acusphere, and Shareholder.com. Earlier in the
quarter, Steve Levine MD joined us as Vice President, Patient
Access; Steve was formerly Founder and CEO at Actify
Neurotherapies. Sarah Bateup was appointed Head of Therapy Research
and Training, having previously been Chief Clinical Officer at Ieso
Digital Health.On 5 August 2020, we entered into a sponsored
research agreement with the University of the Sciences in
Philadelphia, PA, to establish a Drug Discovery Center. The Center
is exploring and developing optimised psychedelic and other early
stage compounds targeting the 5HT2A receptor, a receptor in the
brain that is recognised as a promising target in the treatment of
mental health illnesses.
In July 2020, we were granted our second UK
patent, adding to our US patent and German utility model, and
including claims covering crystalline psilocybin, pharmaceutical
formulations, medical uses, and a method of manufacturing. Our US
patent, granted in December 2019, was the subject of a petition for
post grant review, filed on 21 February 2020; the petition was
dismissed on the merits on 20 August 2020.
We continue to work with a number of academic
and other partners to accelerate research or to provide our COMP360
psilocybin for use in their independent studies. We are providing
funding and support to the Aquilino Cancer Center at Adventist
HealthCare Shady Grove Medical Center, in Rockville, MD, which
recently launched the first clinical trial of psilocybin therapy
with simultaneous administration and one-on-one patient support to
treat depression in cancer patients.
Earlier this month, we joined the Psychiatry
Consortium, an international collaboration of medical research
charities and pharmaceutical companies focused on the challenge of
identifying and validating novel drug targets to address the unmet
therapeutic needs of people living with mental health conditions.
We will work alongside Psychiatry Consortium members and academic
partners to advance research projects, providing support through
access to funding, expertise, and commercialisation know-how. The
Psychiatry Consortium seeks project proposals from the global
psychiatric research community via biannual open calls for
applications - the next call for applications will open in January
2021.
Financial
highlights
Cash position: We held cash and cash
equivalents of $196.5 million as of 30 September 2020, compared
with $67.6 million at 30 June 2020. This is expected to
fund operations into 2023.
Research & development
expenses: R&D expenses were $6.9 million for the three
months ended 30 September 2020, compared with $3.1 million during
the same period in 2019. The change was primarily related to
increased activities associated with our ongoing development of
COMP360, increased share-based compensation, and other increases in
personnel costs to support the development of COMP360. R&D
expenses were $18.8 million for the nine months ended 30 September
2020, compared with $8.0 million during the same period in 2019.
The change was primarily related to increased activities associated
with our ongoing development of COMP360, increased share-based
compensation, and other increases in personnel costs to support the
development of COMP360.
General and administrative
expenses: G&A expenses were $6.6 million for the three
months ended 30 September 2020, compared with $3.1 million during
the same period in 2019. $2.1 million of the increase was related
to share-based compensation expenses, and there were also increases
in legal and professional fees, personnel and consulting expenses,
and facilities costs. G&A expenses were $21.1 million for
the nine months ended 30 September 2020, compared with $5.9 million
during the same period in 2019. $9.7 million of the increase was
related to share-based compensation expenses, and there were also
increases in legal and professional fees, personnel and consulting
expenses, and facilities costs.
Other income (expense), net: Other income
(expense), net was a net expense of $3.1 million for the three
months ended 30 September 2020, compared with a net income of $0.6
million during the same period in 2019. $4.3 million of the
increase in net expense related to foreign exchange
losses. Other income (expense), net was a net expense of $1.5
million for the nine months ended 30 September 2020, compared with
a net income of $1.9 million during the same period in 2019. $3.3
million of the increase in net expense related to foreign exchange
losses.
Net loss: The net loss for the three months
ended 30 September 2020 was $16.7 million, or $1.30 loss per share,
(after including non-cash share-based compensation expense of $5.2
million), compared with $5.7 million, or $0.73 loss per share,
during the same period in 2019 (after including non-cash
share-based compensation expense of $1.8 million).
The net loss for the nine months ended 30
September 2020 was $41.5 million, or $3.90 loss per share, (after
including non-cash share-based compensation expense of $16.6
million), compared with $12.0 million, or $1.68 loss per share,
during the same period in 2019, (after including non-cash
share-based compensation expense of $2.5 million).
Conference call
The COMPASS Pathways management team will host a conference call
at 1.00pm GMT (8.00am ET) on 12 November 2020. The call can be
accessed by dialling (833) 665-0659 from the United States, +1
(914) 987-7313 internationally, and 0800 028 8438 from the UK,
followed by the conference ID: 9377988.
The call will also be webcast live on the
investors section of the COMPASS Pathways website
(ir.compasspathways.com). The webcast will be archived for 30
days.
-Ends-
About COMPASS Pathways
COMPASS 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 therapy, 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 US Food and Drug
Administration (FDA), for treatment-resistant depression (TRD), and
we are currently conducting a phase IIb clinical trial of
psilocybin therapy for TRD, in 21 sites across Europe and North
America. We are headquartered in London, UK, with offices in New
York, USA. Our vision is a world of mental
wellbeing. www.compasspathways.com
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, 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
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. 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; and those risks and uncertainties described
under the heading “Risk Factors” in COMPASS’s Prospectus filed with
the US Securities and Exchange Commission (SEC) on 21 September
2020 and in subsequent filings made by COMPASS with the 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.
Enquiries
COMPASS Pathways Tracy Cheung, tracy@compasspathways.com, +44
7966 309024 Amy Lawrence, amy@compasspathways.com, +44 7813
777919
Westwicke (for investor enquiries)Stephanie Carrington,
stephanie.carrington@westwicke.com, +1 646 277 1282
COMPASS PATHWAYS PLC |
|
|
Condensed Consolidated Balance Sheets |
|
|
(unaudited) |
|
|
(in
thousands, except share and per share amounts) |
|
|
(expressed
in U.S. Dollars, unless otherwise stated) |
|
|
|
September
30, |
December
31, |
2020 |
2019 |
ASSETS |
|
|
CURRENT
ASSETS: |
|
|
Cash |
$ |
196,505 |
|
$ |
24,966 |
Restricted cash |
29 |
|
18 |
Prepaid expenses and other current assets |
10,671 |
|
7,187 |
Total current assets |
207,205 |
|
32,171 |
Investments |
500 |
|
— |
Property and
equipment, net |
231 |
|
218 |
Other
assets |
59 |
|
— |
Total assets |
$ |
207,995 |
|
$ |
32,389 |
LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS'
DEFICIT |
|
|
CURRENT
LIABILITIES: |
|
|
Accounts payable |
$ |
2,630 |
|
$ |
1,262 |
Accounts payable - due to a related party |
13 |
|
63 |
Accrued expenses and other liabilities |
2,277 |
|
1,457 |
Convertible notes payable |
— |
|
12,397 |
Convertible notes payable - due to a related party |
— |
|
8,692 |
Total current liabilities |
4,920 |
|
23,871 |
Total liabilities |
4,920 |
|
23,871 |
|
|
|
Commitments
and contingencies |
|
|
Convertible preferred shares, £0.008 par value; no shares
authorized, issued and outstanding at September 30, 2020; 9,782,505
shares authorized, issued and outstanding at December 31, 2019;
aggregate liquidation preference of $39,279 |
— |
|
38,908 |
SHAREHOLDERS’ EQUITY (DEFICIT): |
|
|
Ordinary shares, £0.008 par value; 35,930,331 and 10,752,429 shares
authorized, issued and outstanding at September 30, 2020 and
December 31, 2019, respectively |
367 |
|
111 |
Deferred shares, £21,391.504 par value; one share authorized,
issued and outstanding at September 30, 2020; no shares authorized,
issued and outstanding at December 31, 2019 |
28 |
|
— |
Additional paid-in capital |
278,098 |
|
7,162 |
Accumulated other comprehensive income (loss) |
3,675 |
|
-98 |
Accumulated deficit |
-79,093 |
|
-37,565 |
Total shareholders’ equity (deficit) |
203,075 |
|
-30,390 |
Total liabilities, convertible preferred shares and shareholders’
deficit |
$ |
207,995 |
|
$ |
32,389 |
|
|
|
|
|
|
COMPASS PATHWAYS PLC |
Condensed
Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited) |
(in thousands,
except share and per share
amounts) |
|
Three Months Ended September |
Nine Months Ended September |
|
2020 |
2019 |
2020 |
2019 |
OPERATING
EXPENSES: |
|
|
|
|
Research and development |
$ |
6,875 |
|
$ |
3,121 |
|
$ |
18,822 |
|
$ |
7,987 |
General and administrative |
6,551 |
|
3,107 |
20,909 |
5,730 |
General and administrative - fees due to a related party |
56 |
|
42 |
143 |
135 |
Total operating expenses |
13,482 |
|
6,270 |
39,874 |
13,852 |
LOSS FROM
OPERATIONS: |
-13,482 |
|
-6,270 |
-39,874 |
-13,852 |
OTHER INCOME
(EXPENSE), NET: |
|
|
|
|
Other income |
109 |
|
17 |
302 |
52 |
Foreign exchange gains (losses) |
-4,331 |
|
45 |
-3,252 |
67 |
Fair value change of convertible notes |
— |
|
— |
-1,031 |
— |
Fair value change of convertible notes - due to a related
party |
— |
|
— |
-723 |
— |
Benefit from R&D tax credit |
1,092 |
|
528 |
3,175 |
1,756 |
Total other income (expense), net |
-3,130 |
|
590 |
-1,529 |
1,875 |
Loss before
income taxes |
-16,612 |
|
-5,680 |
-41,403 |
-11,977 |
Income tax benefit (expense) |
-82 |
|
— |
-125 |
— |
Net
loss |
-16,694 |
|
-5,680 |
-41,528 |
-11,977 |
Other
comprehensive (loss) income: |
|
|
|
|
Foreign exchange translation adjustment |
4,806 |
|
-558 |
3,773 |
-577 |
Comprehensive loss |
$ |
-11,888 |
|
$ |
-6,238 |
|
$ |
-37,755 |
|
$ |
-12,554 |
Net loss per
share attributable to ordinary shareholders—basic and diluted |
$ |
-1.3 |
|
$ |
-0.73 |
|
$ |
-3.9 |
|
$ |
-1.68 |
Weighted
average ordinary shares outstanding—basic and diluted |
12,834,889 |
|
7,789,132 |
10,638,738 |
7,134,760 |
|
|
|
|
|
|
|
|
|
|
|
|
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