– Initiated Phase 2b dose-optimization trial in patients with
Generalized Anxiety Disorder, with first patients dosed in Q3 2022
and key clinical readout expected in late 2023 –
– Advanced IND-enabling studies for MM-402 and
initiated Phase 1 investigator-initiated trial in Q3 2022
–
– Cash and cash equivalents of $154.5 million expected to fund current operating
plan into first half of 2025 -
– Company to host conference call today at
8:30 AM ET –
NEW
YORK, Nov. 10, 2022 /CNW/ -- Mind Medicine
(MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the "Company" or
"MindMed"), a clinical stage biopharmaceutical company developing
novel products to treat brain health disorders, today reported its
financial results for the quarter ended September 30, 2022.

"We are pleased with the progress made in the third quarter as
we continue executing on our core development programs, MM-120 and
MM-402, and accelerating preparations for Phase 3 studies – all
with the goal of bringing our treatments to market as efficiently
as possible for the benefit of both patients and shareholders.
During the quarter, we initiated enrollment in the largest
well-controlled clinical trial of LSD, a 200-patient Phase
2b trial in patients diagnosed with
Generalized Anxiety Disorder (GAD). We expect a readout of that
data in the late half of 2023.
Additionally, we continue our efforts to bring MM-402 into human
clinical studies," said Robert
Barrow, Chief Executive Officer and Director of MindMed.
"Throughout the third quarter, we have taken meaningful steps to
reduce our cash expenditures and we further bolstered our balance
sheet by raising approximately $60
million. We believe our strong financial position provides
the Company with necessary funding to prepare for later stage
clinical development of MM-120 while continuing our pursuit to
retain, protect, and build the Company's intellectual property
portfolio."
Business Update
The Company enhanced and strengthened its financial resources
with approximately $60.0 million in
gross proceeds as a result of sales pursuant to our at-the-market
selling program and a public offering. During the quarter, the
Company also regained compliance with Nasdaq's minimum bid price
listing requirement.
Development Program Updates and
Anticipated Milestones:
MM-120 (LSD D-tartrate): a proprietary, pharmaceutically
optimized form of lysergic acid diethylamide (LSD) that is
primarily being developed for the treatment of generalized anxiety
disorder (GAD).
- In August 2022, the Company
initiated patient dosing in the Phase 2b dose-optimization study of MM-120 for the
treatment of GAD. Patient enrollment is currently ongoing and
topline results are expected in the late half of 2023.
- In September 2022, results from a
Phase 2 placebo-controlled investigator-initiated clinical trial of
LSD in the treatment of anxiety disorders (LSD-Assist Study) were
published in the peer-reviewed scientific journal Biological
Psychiatry. Topline results in 46 patients with clinically
significant anxiety demonstrated the significant, rapid, durable,
and beneficial effects of LSD and its potential to safely mitigate
symptoms of anxiety and depression.
- Enrollment is ongoing for Study MMED007, a Phase 2a
proof-of-concept trial for the treatment of ADHD. The study is
designed to assess the safety and efficacy of repeated low-dose
MM-120 administration. The Company expects topline results in the
late half of 2023.
- The Company continues to prioritize and focus its current
development efforts and resources on MM-120 in psychiatric
indications. MindMed currently owns and retains all clinical data
and manufacturing rights for MM-120 and is aggressively protecting
and expanding its intellectual property portfolio.
MM-402 or R(-)-MDMA: a synthetic R-enantiomer of
3,4-Methylenedioxymethamphetamine
(MDMA) that the Company is developing for the treatment of core
symptoms of autism spectrum disorder.
- IND-enabling studies are currently ongoing and initiation of a
Phase 1 clinical trial of MM-402 is planned in 2023.
- A Phase 1 pharmacokinetic/pharmacodynamic
investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA
in healthy volunteers is currently underway through the Company's
collaboration with the University Hospital Basel in Switzerland.
Third Quarter 2022 Financial and
Other Recent Highlights
Cash Balance. As of September
30, 2022, MindMed had cash and cash equivalents totaling
$154.5 million compared to
$133.5 million as of December 31, 2021. MindMed believes its available
cash and cash equivalents will be sufficient to meet its operating
requirements into the first half of 2025.
Net Cash in Operating Activities. The net cash used
in operating activities was $37.3
million for the nine months ended September 30, 2022, compared to $38.0 million for the same period in 2021.
Research and Development (R&D). R&D expenses were
$7.8 million for the three months
ended September 30, 2022, compared to
$9.0 million for the three months
ended September 30, 2021, a decrease
of $1.2 million. The decrease was
primarily due to a decrease of $1.4
million of external costs related to the MM-110 research
program and $0.8 million decrease in
preclinical activities. This decrease was partially offset by an
increase of internal personnel costs of $1.5
million as we continue to expand our in-house research and
development capabilities. For the nine months ended September 30, 2022, research and development
expenses were $27.3 million, compared
to $23.9 million for the nine months
ended September 30, 2021, an increase
of $3.4 million. The increase was
primarily driven by an increase of $5.6
million of internal personnel costs related to additional
research and development headcount and an increase of $2.9 million external costs related to the MM-120
research program. These increases were partially offset by a
decrease of external costs related to the MM-110 research program
of $3.7 million.
General and Administrative (G&A). G&A expenses
were $9.2 million for the three
months ended September 30, 2022,
compared to $8.2 million for the
three months ended September 30,
2021, an increase of $1.0
million. The increase was primarily related to issuance
costs related to the Company's public equity offering which closed
during the third quarter. For the nine months ended September 30, 2022, general and administrative
expenses were $25.1 million, compared
to $52.4 million for the nine months
ended September 30, 2021, a decrease
of $27.3 million. The decrease was
primarily due to a decrease of $26.4
million in non-cash stock-based compensation expenses
relating to the modification of stock option awards and RSUs
recorded during the nine months ended September 30, 2021.
Net Loss. The net loss for the three months ended
September 30, 2022 was $16.5 million, compared to $17.2 million for the same period in 2021. For
the nine months ended September 30,
2022, net loss was $51.9
million compared to $76.2
million for the same period in 2021.
Conference Call and Webcast
Reminder
MindMed management will host a conference call at 8:30 AM ET today to provide a corporate update
and review the company's third quarter 2022 financial results.
Individuals may participate via telephone by dialing (888) 999-3182
(domestic) or (848) 280-6330 (international) and using conference
ID 8072033. The webcast can be accessed on MindMed's Investor
Resources webpage. The webcast will be archived on the
company's website for at least 30 days after the conference
call.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing
novel products to treat brain health disorders. Our mission is to
be the global leader in the development and delivery of treatments
that unlock new opportunities to improve patient outcomes. We are
developing a pipeline of innovative drug candidates, with and
without acute perceptual effects, targeting the serotonin, dopamine
and acetylcholine systems.
MindMed trades on NASDAQ under the symbol MNMD and on the
Canadian NEO Exchange under the
symbol MMED.
Forward-Looking
Statements
Certain statements in this news release related to the Company
constitute "forward-looking information" within the meaning of
applicable securities laws and are prospective in nature.
Forward-looking information is not based on historical facts, but
rather on current expectations and projections about future events
and are therefore subject to risks and uncertainties which could
cause actual results to differ materially from the future results
expressed or implied by the forward-looking statements. These
statements generally can be identified by the use of
forward-looking words such as "will", "may", "should", "could",
"intend", "estimate", "plan", "anticipate", "expect", "believe",
"potential" or "continue", or the negative thereof or similar
variations. Forward-looking information in this news release
include, but are not limited to, statements regarding anticipated
upcoming milestones and studies, results and timing of clinical
studies, and the availability of cash and cash equivalents. There
are numerous risks and uncertainties that could cause actual
results and the Company's plans and objectives to differ materially
from those expressed in the forward-looking information, including
history of negative cash flows; limited operating history;
incurrence of future losses; availability of additional capital;
lack of product revenue; compliance with laws and regulations;
difficulty associated with research and development; risks
associated with clinical trials or studies; heightened regulatory
scrutiny; early stage product development; clinical trial risks;
regulatory approval processes; novelty of the psychedelic inspired
medicines industry; as well as those risk factors discussed or
referred to herein and the risks described in the Company's Annual
Report on Form 10-K for the fiscal year ended December 31, 2021 and its Quarterly Report on
Form 10-Q for the period ended June 30,
2022 under headings such as "Special Note Regarding
Forward-Looking Statements," and "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" and other filings and furnishings made by the Company
with the securities regulatory authorities in all provinces and
territories of Canada which are
available under the Company's profile on SEDAR at www.sedar.com and
with the U.S. Securities and Exchange Commission on EDGAR at
www.sec.gov. Except as required by law, the Company undertakes no
duty or obligation to update any forward-looking statements
contained in this release as a result of new information, future
events, changes in expectations or otherwise.
For Media: media@mindmed.co
For Investors: ir@mindmed.co
Mind Medicine
(MindMed) Inc.
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
(Unaudited)
|
(In thousands,
except share and per share amounts)
|
|
|
|
Three Months
Ended September 30,
|
|
|
Nine Months
Ended September 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
7,772
|
|
|
$
|
9,019
|
|
|
$
|
27,339
|
|
|
$
|
23,906
|
|
General and
administrative
|
|
|
9,211
|
|
|
|
8,208
|
|
|
|
25,092
|
|
|
|
52,390
|
|
Total operating
expenses
|
|
|
16,983
|
|
|
|
17,227
|
|
|
|
52,431
|
|
|
|
76,296
|
|
Loss from
operations
|
|
|
(16,983)
|
|
|
|
(17,227)
|
|
|
|
(52,431)
|
|
|
|
(76,296)
|
|
Other
income/(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income/(expense), net
|
|
|
360
|
|
|
|
(64)
|
|
|
|
443
|
|
|
|
(220)
|
|
Foreign exchange
gain/(loss), net
|
|
|
138
|
|
|
|
(40)
|
|
|
|
94
|
|
|
|
94
|
|
Other
income
|
|
|
—
|
|
|
|
135
|
|
|
|
1
|
|
|
|
215
|
|
Total other
income
|
|
|
498
|
|
|
|
31
|
|
|
|
538
|
|
|
|
89
|
|
Loss before income
taxes
|
|
|
(16,485)
|
|
|
|
(17,196)
|
|
|
|
(51,893)
|
|
|
|
(76,207)
|
|
Income taxes
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Net loss
|
|
|
(16,485)
|
|
|
|
(17,196)
|
|
|
|
(51,893)
|
|
|
|
(76,207)
|
|
Other comprehensive
gain/(loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)/gain on foreign
currency translation
|
|
|
(107)
|
|
|
|
(383)
|
|
|
|
(303)
|
|
|
|
380
|
|
Comprehensive
loss
|
|
$
|
(16,592)
|
|
|
$
|
(17,579)
|
|
|
$
|
(52,196)
|
|
|
$
|
(75,827)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.56)
|
|
|
$
|
(0.61)
|
|
|
$
|
(1.82)
|
|
|
$
|
(2.81)
|
|
Weighted-average common
shares, basic and diluted
|
|
|
29,296,333
|
|
|
|
28,013,809
|
|
|
|
28,566,161
|
|
|
|
27,124,297
|
|
Mind Medicine
(MindMed) Inc.
|
Condensed
Consolidated Balance Sheets
|
(In thousands,
except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2022
|
|
|
December 31,
2021
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
154,519
|
|
|
$
|
133,539
|
|
|
Prepaid and other
current assets
|
|
|
1,826
|
|
|
|
3,676
|
|
|
Right of use
asset
|
|
|
165
|
|
|
|
—
|
|
|
Total current
assets
|
|
|
156,510
|
|
|
|
137,215
|
|
|
Goodwill
|
|
|
19,918
|
|
|
|
19,918
|
|
|
Intangible assets,
net
|
|
|
4,479
|
|
|
|
6,869
|
|
|
Total assets
|
|
$
|
180,907
|
|
|
$
|
164,002
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
824
|
|
|
$
|
4,178
|
|
|
Accrued
expenses
|
|
|
7,467
|
|
|
$
|
6,230
|
|
|
2022 USD Financing
Warrants
|
|
|
17,747
|
|
|
|
—
|
|
|
Total current
liabilities
|
|
|
26,038
|
|
|
|
10,408
|
|
|
Other liabilities,
long-term
|
|
|
1,276
|
|
|
|
1,930
|
|
|
Total
liabilities
|
|
|
27,314
|
|
|
|
12,338
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
Equity:
|
|
|
|
|
|
|
|
Common shares, no par
value, unlimited authorized as of September 30, 2022 and December
31, 2021; 37,541,115 and 28,126,414 issued and outstanding as of
September 30, 2022 and December 31, 2021, respectively
|
|
|
—
|
|
|
|
—
|
|
|
Additional paid-in
capital
|
|
|
342,415
|
|
|
|
288,290
|
|
|
Accumulated other
comprehensive (loss)/income
|
|
|
743
|
|
|
|
1,046
|
|
|
Accumulated
deficit
|
|
|
(189,565)
|
|
|
|
(137,672)
|
|
|
Total shareholders'
equity
|
|
|
153,593
|
|
|
|
151,664
|
|
|
Total liabilities and
shareholders' equity
|
|
$
|
180,907
|
|
|
$
|
164,002
|
|
|
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SOURCE Mind Medicine (MindMed) Inc.