– Topline readout of MM-120 in GAD (Phase 2b)
expected in Q4 2023 –
– Topline readout of MM-120 in ADHD (Phase 2a
proof-of-concept) anticipated by the end of Q1 2024 –
– MM-402 in ASD on track for Phase 1 clinical
trial initiation in Q4 2023 –
– Cash and cash equivalents of $117.7 million
at September 30, 2023 –
– Company to host conference call today at 4:30
PM ET –
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the
“Company” or “MindMed”), a clinical stage biopharmaceutical company
developing novel product candidates to treat brain health
disorders, today reported its financial results for the quarter
ended September 30, 2023.
“During the third quarter we continued to focus on execution
ahead of several key data readouts in the coming months. This
includes, in particular, topline results from our Phase 2b study of
MM-120 in generalized anxiety disorder (GAD) which are anticipated
by the end of this year. Additionally, we anticipate the initiation
of our Phase 1 study of MM-402 by the end of this year and
reporting topline data from our proof-of-concept study of MM-120 in
ADHD by the end of Q1 2024.” said Robert Barrow, Chief Executive
Officer and Director of MindMed. “The continued growth in
prevalence and impact of GAD, ASD and other brain health disorders
highlights the importance and timeliness of our innovative
programs. Our team remains singularly focused on delivering novel
treatments for brain health disorders to the millions of patients
in need and we are eager to share these important milestones in the
months ahead.”
Recent Highlights and Anticipated Upcoming
Milestones:
Phase 2b study evaluating MM-120 for generalized anxiety
disorder (GAD) in adults.
- Study MMED008 is a multi-center, parallel, randomized,
double-blind, placebo-controlled, dose-optimization study. The
trial enrolled 198 participants who were randomized to receive a
single oral administration of MM-120 (25 µg, 50 µg, 100 µg or 200
µg) or placebo.
- The primary objective of the study is to determine the
dose-response relationship of four doses of MM-120 versus placebo
as measured by the change in Hamilton Anxiety Rating Scale (HAM-A)
from Baseline to Week 4.
- Dosing is complete with topline results for the primary
endpoint (Week 4) expected to be announced in Q4 2023.
- We anticipate the announcement of 12-week safety and efficacy
results by the end of Q1 2024 and the presentation of the full data
from the study at a scientific meeting in 2024.
Proof-of-Concept study evaluating repeated low-dose
administration of MM-120 for attention-deficit/hyperactivity
disorder (ADHD) in adults.
- Study MMED007 is a multi-center, randomized, double-blind,
placebo-controlled study. The trial enrolled 53 participants who
were randomized to receive twice-weekly oral doses of MM-120 20 μg
or placebo for 6 weeks.
- Topline results expected by the end of Q1 2024.
- The primary endpoint of this study is the mean change from
baseline at Week 6 in ADHD symptoms, as assessed by the Adult ADHD
Investigator Rating Scale (AISRS).
Advancing development of MM-402 (R(-)-MDMA) for autism
spectrum disorder (ASD) into first clinical trial in Q4
2023.
- The Company plans to initiate its first clinical trial of
MM-402 in Q4 2023. This Phase 1 study is intended to characterize
the tolerability, pharmacokinetics and pharmacodynamics of MM-402,
and to evaluate early signals of efficacy to support the Company’s
approach in targeting core symptoms of ASD in adults.
- University Hospital Basel (UHB) in Switzerland, the Company’s
collaborator, is currently enrolling participants in a Phase 1
investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA
in healthy adult volunteers. This trial is designed to assess the
tolerability, pharmacokinetics and acute subjective, physiological
and endocrine effects of the three molecules. The Company
anticipates topline results to be presented in the first half of
2024.
- In October 2023, the Company presented results from a MM-402
nonclinical study in a model of ASD, titled “MM-402 demonstrates
better efficacy than S(+)-3,4-MDMA or (±)-3,4-MDMA in Fmr1 knockout
mice, an animal model of autism spectrum disorder” at the 36th
Annual European College of Neuropsychopharmacology (ECNP)
Congress.
Third Quarter 2023 Financial Results
Cash and Cash Equivalents Balance. As of September 30, 2023,
MindMed had cash and cash equivalents totaling $117.7 million
compared to $142.1 million as of December 31, 2022. The Company
believes its available cash and cash equivalents as well as its
committed credit facility are expected to fund operations into
2026, if certain milestones are achieved that unlock additional
capital.
Net Cash Used in Operating Activities. For the nine months ended
September 30, 2023, net cash used in operating activities was $43.8
million, compared to $37.3 million in the nine months ended
September 30, 2022.
Research and Development (R&D). R&D expenses were $13.2
million for the quarter ended September 30, 2023, compared to $7.8
million for the quarter ended September 30, 2022, an increase of
$5.4 million. The increase was primarily due to increases of $6.4
million in expenses related to clinical research and product
development for the MM-120 GAD study, and $0.4 million in internal
personnel costs as a result of increasing research and development
capacities, partially offset by a decrease of $0.4 million in
expenses related to our MM-402 program, a decrease of $0.2 million
related to our paused MM-110 program, a decrease of $0.5 million in
preclinical activities, and a decrease of $0.2 million in
connection with various external R&D collaborations.
General and Administrative (G&A). G&A expenses were $8.4
million for the quarter ended September 30, 2023, compared to $9.2
million for the quarter ended September 30, 2022, a decrease of
$0.8 million. The decrease was primarily related to issuance costs
related to the Company's 2022 USD Financing Warrants that were
issued as part of the Company's public equity offering which closed
on September 30, 2022.
Net Loss. Net loss for the quarter ended September 30, 2023, was
$17.9 million, compared to $16.5 million for the same period in
2022.
Conference Call and Webcast Reminder
MindMed management will host a conference call at 4:30 PM EST
today to provide a corporate update and review the Company’s third
quarter 2023 financial results. Individuals may participate in the
live call via telephone by dialing (855) 327-6837 (domestic) or
(631) 891-4304 (international). The webcast can be accessed live
here on the Financials page in the Investors section of the MindMed
website, https://mindmed.co/. 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 product candidates 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 product
candidates, with and without acute perceptual effects, targeting
neurotransmitter pathways that play key roles in brain health
disorders.
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
includes, but is not limited to, statements regarding the progress
of trials and studies; results and timing of and reporting of
topline data from clinical trials; the potential benefits of the
Company’s product candidates, and the Company’s cash runway and
committed credit facility funding its operations into 2026 if
certain milestones are achieved that unlock additional capital.
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;
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, 2022, the Company’s Quarterly Report
on Form 10-Q for the fiscal quarter ended September 30, 2023 under
headings such as “Special Note Regarding Forward-Looking
Statements,” “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.
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,
2023
2022
2023
2022
Operating expenses:
Research and development
$
13,203
$
7,772
$
40,578
$
27,339
General and administrative
8,413
9,211
31,083
25,092
Total operating expenses
21,616
16,983
71,661
52,431
Loss from operations
(21,616
)
(16,983
)
(71,661
)
(52,431
)
Other income/(expense):
Interest income, net
1,163
360
3,759
443
Foreign exchange (loss)/gain, net
(439
)
138
(244
)
94
Change in fair value of 2022 USD Financing
Warrants
3,020
—
(3,671
)
—
Other (expense)/income
(51
)
—
(51
)
1
Total other income/(expense), net
3,693
498
(207
)
538
Net loss
(17,923
)
(16,485
)
(71,868
)
(51,893
)
Other comprehensive loss
Gain/(loss) on foreign currency
translation
415
(107
)
150
(303
)
Comprehensive loss
$
(17,508
)
$
(16,592
)
$
(71,718
)
$
(52,196
)
Net loss per common share, basic and
diluted
$
(0.45
)
$
(0.56
)
$
(1.85
)
$
(1.82
)
Weighted-average common shares, basic and
diluted
39,720,007
29,296,333
38,798,374
28,566,161
Mind Medicine (MindMed)
Inc. Condensed Consolidated Balance Sheets (In
thousands, except share amounts)
September 30, 2023
(unaudited)
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$
117,699
$
142,142
Prepaid and other current assets
2,387
3,913
Total current assets
120,086
146,055
Goodwill
19,918
19,918
Intangible assets, net
1,317
3,689
Other non-current assets
229
331
Total assets
$
141,550
$
169,993
Liabilities and Shareholders’
Equity
Current liabilities:
Accounts payable
$
7,686
$
2,111
Accrued expenses
9,957
5,877
2022 USD Financing Warrants
13,511
9,904
Total current liabilities
31,154
17,892
Credit facility, long-term
14,068
—
Other liabilities, long-term
349
1,184
Total liabilities
45,571
19,076
Shareholders' Equity:
Common shares, no par value, unlimited
authorized as of September 30, 2023 and December 31, 2022;
40,094,708 and 37,979,136 issued and outstanding as of September
30, 2023 and December 31, 2022, respectively
—
—
Additional paid-in capital
361,538
344,758
Accumulated other comprehensive income
777
627
Accumulated deficit
(266,336
)
(194,468
)
Total shareholders' equity
95,979
150,917
Total liabilities and shareholders'
equity
$
141,550
$
169,993
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231102112239/en/
For Media & Investor Inquiries: Maxim Jacobs, CFA
Vice President, Investor Relations and Corporate Communications
Mind Medicine (MindMed) Inc. ir@mindmed.co media@mindmed.co
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