Neumora Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
2024年8月6日 - 8:00PM
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 second
quarter ended June 30, 2024, and provided a business update.
“The first half of the year was marked by considerable progress
across our robust clinical development pipeline as we seek to
pioneer a new era in brain diseases,” said Henry Gosebruch,
president and chief executive officer, Neumora. “We are excited for
the topline data readout from our pivotal Phase 3 KOASTAL-1 study
of navacaprant to treat major depressive disorder (MDD), which we
continue to expect in the fourth quarter. We are committed to
bringing navacaprant to the millions of patients suffering with MDD
as expeditiously as possible.”
“Additionally, we’re making significant progress across the rest
of our pipeline with the recent initiations of a Phase 2 study of
navacaprant as a treatment for bipolar depression and a Phase 1b
study of NMRA-511 in Alzheimer's disease agitation, as well as
narrowing guidance to submit an IND for an additional M4 compound
in the first half of 2025. These are areas of substantial unmet
medical need, and we are confident that our novel mechanisms have
strong rationales with the potential for favorable benefit-risk
profiles,” added Mr. Gosebruch.
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 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.
- Neumora remains on-track to report data from the KOASTAL
studies within previously guided timeframes. The Company 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.
Beyond MDD, Neumora recently initiated a Phase 2 clinical trial
evaluating the potential of navacaprant as treatment for bipolar
depression. The randomized, double-blind, placebo-controlled, Phase
2 clinical trial is designed to evaluate the safety and efficacy of
navacaprant in people with depression associated with bipolar II
disorder. Neumora expects to report topline data from this trial in
the second half of 2025.
NMRA-511: Ongoing Phase 1b Study in Alzheimer’s Disease
(AD) Agitation
NMRA-511 is a highly selective, novel antagonist of the
vasopressin 1a receptor (V1aR) being developed for the treatment of
agitation associated with dementia due to AD and other
neuropsychiatric disorders.
- In June 2024, the Company initiated a Phase 1b study in
investigating NMRA-511 initially in healthy elderly adult
participants and then people with agitation associated with
dementia due to AD. The Company expects to report data from this
study in the second half of 2025.
M4 Positive Allosteric Modulator (PAM) Franchise:
Advancing Preclinical Work Across Compounds, with IND expected in
the first half of 2025
Neumora’s M4 franchise is comprised of multiple novel compounds
that each have different properties and chemical composition,
including NMRA-266.
- The Phase 1 single ascending dose / multiple ascending dose
study with NMRA-266 is currently paused following a clinical hold
determination by the U.S. Food and Drug Administration (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 preclinical safety and toxicology work
with its additional M4 PAM compounds and has narrowed the guidance
for bringing an additional M4 PAM compound into the clinic from its
prior guidance of 2025. The Company now expects to submit an IND in
the first half of 2025.
SECOND QUARTER 2024 FINANCIAL RESULTS
- Cash Position: As of June 30, 2024, Neumora
had cash, cash equivalents and marketable securities of $371.6
million.
- Financial Guidance: The Company expects that
its cash, cash equivalents and marketable securities as of June 30,
2024, will enable it to fund its operating plan into 2026.
- R&D Expense: Research and development
expenses for the second quarter of 2024 were $48.6 million, as
compared to $32.8 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 second quarter of 2024 were $15.2 million, as
compared to $9.3 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
$58.7 million for the second quarter of 2024, as compared to $38.5
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; Neumora’s goal to make navacaprant available as
expeditiously as possible for MDD patients; the timing, progress
and plans for its therapeutic development programs, including the
timing of patient enrollment, initiation and data read outs for its
programs and studies, as well as its clinical trial and development
plans and the potential for Neumora’s clinical pipeline to create
value; 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; 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 Quarterly Report on Form 10-Q for the quarter ended June 30,
2024 that was filed with the SEC on or about the date hereof.
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. Our results for
the quarter ended June 30, 2024 are also not necessarily indicative
of our operating results for any future periods.
Financial Tables
| |
|
| NEUMORA
THERAPEUTICS, INC. |
| Unaudited
Consolidated Statements of Operations and Comprehensive
Loss |
| (in
thousands, except per share amounts) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended June 30, |
|
Six Months
Ended June 30, |
|
|
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
| Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
48,628 |
|
|
$ |
32,769 |
|
|
$ |
94,385 |
|
|
$ |
62,254 |
|
|
|
General and administrative |
|
|
15,194 |
|
|
|
9,293 |
|
|
|
29,511 |
|
|
|
18,976 |
|
|
| Total
operating expenses |
|
|
63,822 |
|
|
|
42,062 |
|
|
|
123,896 |
|
|
|
81,230 |
|
|
| Loss from
operations |
|
|
(63,822 |
) |
|
|
(42,062 |
) |
|
|
(123,896 |
) |
|
|
(81,230 |
) |
|
| Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
5,271 |
|
|
|
3,558 |
|
|
|
11,636 |
|
|
|
7,127 |
|
|
|
Other expense, net |
|
|
(24 |
) |
|
|
(39 |
) |
|
|
(36 |
) |
|
|
(65 |
) |
|
| Total other
income |
|
|
5,247 |
|
|
|
3,519 |
|
|
|
11,600 |
|
|
|
7,062 |
|
|
| Net loss
before income taxes |
|
|
(58,575 |
) |
|
|
(38,543 |
) |
|
|
(112,296 |
) |
|
|
(74,168 |
) |
|
|
Provision for income taxes |
|
|
125 |
|
|
|
— |
|
|
|
125 |
|
|
|
— |
|
|
| Net
loss |
|
|
(58,700 |
) |
|
|
(38,543 |
) |
|
|
(112,421 |
) |
|
|
(74,168 |
) |
|
| Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
|
(39 |
) |
|
|
(150 |
) |
|
|
(111 |
) |
|
|
326 |
|
|
|
Comprehensive loss |
|
$ |
(58,739 |
) |
|
$ |
(38,693 |
) |
|
$ |
(112,532 |
) |
|
$ |
(73,842 |
) |
|
| Net loss per
share, basic and diluted |
|
$ |
(0.37 |
) |
|
$ |
(1.28 |
) |
|
$ |
(0.71 |
) |
|
$ |
(2.50 |
) |
|
|
Weighted-average shares outstanding, basic and diluted |
|
|
158,984 |
|
|
|
30,125 |
|
|
|
158,464 |
|
|
|
29,704 |
|
|
| |
|
|
|
|
|
|
|
|
|
|
Neumora Therapeutics, Inc. |
|
| Unaudited
Condensed Consolidated Balance Sheets |
|
| (in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
June 30, 2024 |
|
December 31, 2023 |
|
|
Cash, cash equivalents and marketable securities |
|
$ |
371,639 |
|
$ |
463,827 |
|
| Total
assets |
|
$ |
404,473 |
|
$ |
496,195 |
|
| Total
liabilities |
|
$ |
23,214 |
|
$ |
27,119 |
|
| Total
stockholders’ equity |
|
$ |
381,259 |
|
$ |
469,076 |
|
| |
|
|
|
|
|
Neumora ContactHelen Rubinstein+1 (315)
382-3979Helen.Rubinstein@neumoratx.com
Neumora Therapeutics (NASDAQ:NMRA)
過去 株価チャート
から 7 2024 まで 8 2024
Neumora Therapeutics (NASDAQ:NMRA)
過去 株価チャート
から 8 2023 まで 8 2024
