Neumora Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update
May 07 2024 - 7:00AM
Neumora Therapeutics, Inc. (Nasdaq: NMRA) a
clinical-stage biopharmaceutical company with a therapeutics
pipeline consisting of seven clinical and pre-clinical brain
disease programs, today announced financial results for the first
quarter ended March 31, 2024, and provided a business update.
“We are laser focused on high-quality clinical execution as we
advance toward the Phase 3 topline data readout for navacaprant in
the fourth quarter,” said Henry Gosebruch, president and chief
executive officer, Neumora. “We are well-positioned to achieve
multiple potential value creating catalysts in 2024 and 2025 across
our strong pipeline, which is focused on alleviating the
substantial unmet medical need in neuropsychiatric and
neurodegenerative diseases with multiple targets that are supported
by strong biological rationale and clinical validation.”
KEY PIPELINE HIGHLIGHTS
Neumora is advancing a therapeutic pipeline of seven clinical
and preclinical neuroscience programs that target novel mechanisms
of action for a broad range of underserved neuropsychiatric
disorders and neurodegenerative diseases.
Navacaprant (NMRA-140): Phase 3 Data from KOASTAL-1
Study in Major Depressive Disorder (MDD) Expected in the Fourth
Quarter of 2024
Navacaprant (NMRA-140) is a highly selective, novel, once-daily
kappa opioid receptor (KOR) antagonist being developed as a
potential monotherapy treatment for MDD and other neuropsychiatric
disorders. The KOR antagonist approach has been clinically
validated in three independent studies.
Neumora is currently enrolling the registrational Phase 3
KOASTAL program, which is designed to evaluate the efficacy and
safety of navacaprant monotherapy for the treatment of MDD.
KOASTAL-1, KOASTAL-2, and KOASTAL-3 are replicate Phase 3,
randomized, placebo-controlled, double-blind studies in adult
patients with MDD.
- The KOASTAL studies are progressing well, and Neumora remains
on-track to report data within previously guided timeframes.
Neumora expects to report topline data from the KOASTAL-1 study in
the fourth quarter of 2024, and topline data from the KOASTAL-2 and
KOASTAL-3 studies in the first half of 2025.
Neumora also intends to evaluate the potential of navacaprant as
treatment for other neuropsychiatric populations beyond MDD,
including bipolar depression (BPD).
- The Company expects to initiate a Phase 2 clinical trial in BPD
in the second quarter of 2024.
NMRA-511: Plan to Initiate Phase 1b Study in Alzheimer’s
Disease Agitation in the Second Quarter of 2024NMRA-511 is
an antagonist of the vasopressin 1a receptor (V1aR), with high
selectivity over V1b, V2 (greater than 3,000-fold) and oxytocin
receptors (approximately 300-fold). Vasopressin plays a role in the
regulation of aggression, affiliation, stress and anxiety
response.
- The Phase 1 single ascending dose / multiple ascending dose
(SAD / MAD) study evaluating NMRA-511 in healthy adult participants
is complete. NMRA-511 was generally well-tolerated in the study,
and results support advancement of the program in people with
Alzheimer’s disease agitation. Neumora looks forward to sharing
more data from the Phase 1 SAD / MAD study in the future.
- Neumora expects to initiate a Phase 1b study in Alzheimer's
disease agitation in the second quarter of 2024, with data from
that study anticipated in 2025.
M4 Positive Allosteric Modulator (PAM) Franchise:
Advancing Preclinical Work Across CompoundsNeumora’s M4
franchise is comprised of multiple novel compounds that each have
different properties and chemical composition, including
NMRA-266.
- Neumora recently announced that the Phase 1 single ascending
dose / multiple ascending dose study with NMRA-266 has been paused
following a clinical hold determination by the FDA. Neumora is
working with the FDA to evaluate the potential to resolve the
clinical hold and will provide an update when available.
Beyond NMRA-266, additional compounds in Neumora’s M4 PAM
franchise also demonstrated robust activity in preclinical efficacy
models, as well as high selectivity for the M4 receptor subtype and
the potential for an oral once-daily dosing profile.
- Neumora is advancing pre-clinical safety and toxicology work
with its additional M4 PAM compounds and expects to submit an IND
in 2025.
BUSINESS UPDATES
- In March 2024, Neumora entered into a funding agreement with
Parkinson’s UK for £2.1 million to support the advancement of
NMRA-NLRP3, an NLRP3 inhibitor with the potential to reduce
inflammation and protect brain cells in Parkinson’s. Neumora is
advancing preclinical work for this program.
FOURTH QUARTER AND FULL YEAR FINANCIAL
RESULTS
- Cash Position: As of March 31, 2024, Neumora
had cash, cash equivalents and marketable securities of $423.0
million.
- Financial Guidance: The Company expects that
its cash, cash equivalents and marketable securities as of March
31, 2024, will enable it to fund its operating plan into 2026.
R&D Expense:
Research and development expenses for the first quarter of 2024
were $45.8 million, as compared to $29.5 million for the same
period in 2023. This increase was primarily due to advancement of
clinical and preclinical programs and related activities for Phase
3 clinical trials evaluating navacaprant as a monotherapy treatment
for MDD.
- G&A Expense: General and administrative
expenses for the first quarter of 2024 were $14.3 million, as
compared to $9.7 million for the same period in 2023. This increase
was primarily due to personnel-related costs, including stock-based
compensation and professional services to support the continued
expansion of administrative functions.
- Net Loss: The Company reported a net loss of
$53.7 million for the first quarter of 2024, as compared to $35.6
million for the same period in 2023.
About NeumoraNeumora Therapeutics, Inc. is a
clinical-stage biopharmaceutical company founded to confront the
global brain disease crisis by taking a fundamentally different
approach to the way treatments for brain diseases are developed.
Our therapeutic pipeline currently consists of seven clinical and
preclinical neuroscience programs that target novel mechanisms of
action for a broad range of underserved neuropsychiatric disorders
and neurodegenerative diseases. Our work is supported by an
integrated suite of translational, clinical, and computational
tools to generate insights that can enable precision medicine
approaches. Neumora’s mission is to redefine neuroscience drug
development by bringing forward the next generation of novel
therapies that offer improved treatment outcomes and quality of
life for patients suffering from brain diseases.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements about Neumora Therapeutics, Inc. (the “Company,” “we,”
“us,” or “our”) within the meaning of the federal securities laws,
including statements related to: Neumora’s intention to redefine
neuroscience drug development by bringing forward the next
generation of novel therapies that offer improved treatment
outcomes and quality of life for patients suffering from brain
diseases; the timing, progress and plans for its therapeutic
development programs, including the timing of initiation and data
read outs for its programs and studies, as well as its clinical
trial and development plans; timing and expectations related to
regulatory filings and interactions; expectations and projections
regarding future operating results and financial performance,
including the sufficiency of its cash resources and expectation of
the timing of its cash runway; its ability to create significant
value and the potential for Neumora to advance other compounds in
its M4 portfolio; the oral one-daily dosing potential of any M4
compounds; the timing and potential for any INDs in Neumora’s M4
portfolio; and; other statements identified by words such as
“could,” “expects,” “intends,” “may,” “plans,” “potential,”
“should,” “will,” “would,” or similar expressions and the negatives
of those terms. Other than statements of historical facts, all
statements contained in this press release, are forward-looking
statements within the meaning of the "safe harbor" provisions of
the Private Securities Litigation Reform Act of 1995. These
statements are subject to risks and uncertainties that could cause
the actual results or to be materially different from the
information expressed or implied by these forward-looking
statements, including, among others: the risks related to the
inherent uncertainty of clinical drug development and
unpredictability and lengthy process for obtaining regulatory
approvals; risks related to the timely initiation and enrollment in
our clinical trials; risks related to our reliance on third
parties, including CROs; risks related to serious or undesirable
side effects of our therapeutic candidates; risks related to our
ability to utilize and protect our intellectual property rights;
and other matters that could affect sufficiency of capital
resources to fund operations. For a detailed discussion of the
risks and uncertainties that could cause actual results to differ
from those expressed in these forward-looking statements, as well
as risks relating to Neumora’s business in general, please refer to
the risk factors identified in the Company’s filings with the
Securities and Exchange Commission (SEC), including but not limited
to its Annual Report on Form 10-K for the year ended December 31,
2023 that was filed with the SEC on March 7, 2024. Forward-looking
statements speak only as of the date hereof, and, except as
required by law, Neumora undertakes no obligation to update or
revise these forward-looking statements.
Financial Tables
NEUMORA
THERAPEUTICS, INC. |
|
Unaudited Consolidated Statements of Operations and
Comprehensive Loss |
|
(in thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
|
|
2024 |
|
2023 |
Operating expenses: |
|
|
|
|
|
Research and development |
|
$ |
45,757 |
|
|
$ |
29,485 |
|
|
General and administrative |
|
|
14,317 |
|
|
|
9,683 |
|
|
Total operating expenses |
|
|
60,074 |
|
|
|
39,168 |
|
|
Loss from operations |
|
|
(60,074 |
) |
|
|
(39,168 |
) |
|
Other income (expense): |
|
|
|
|
|
Interest income |
|
|
6,365 |
|
|
|
3,569 |
|
|
Other expense, net |
|
|
(12 |
) |
|
|
(26 |
) |
|
Total other income |
|
|
6,353 |
|
|
|
3,543 |
|
|
Net loss |
|
|
(53,721 |
) |
|
|
(35,625 |
) |
|
Other comprehensive income (loss): |
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
|
(72 |
) |
|
|
476 |
|
|
Comprehensive loss |
|
$ |
(53,793 |
) |
|
$ |
(35,149 |
) |
|
Net loss per share, basic and diluted |
|
$ |
(0.34 |
) |
|
$ |
(1.22 |
) |
|
Weighted-average shares outstanding, basic and diluted |
|
|
157,943 |
|
|
|
29,277 |
|
|
|
|
|
|
|
|
Unaudited Condensed Consolidated Balance
Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
March 31,2024 |
|
December 31,2023 |
|
Cash, cash equivalents and marketable securities |
|
$ |
423,017 |
|
|
$ |
463,827 |
|
|
Total assets |
|
$ |
450,211 |
|
|
$ |
496,195 |
|
|
Total liabilities |
|
$ |
25,669 |
|
|
$ |
27,119 |
|
|
Total stockholders’ equity |
|
$ |
424,542 |
|
|
$ |
469,076 |
|
|
|
|
|
|
|
|
Neumora Contact
Helen Rubinstein+1 (315)
382-3979Helen.Rubinstein@neumoratx.com
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