Neumora Therapeutics, Inc. (Nasdaq: NMRA), a
clinical-stage biopharmaceutical company redefining neuroscience
drug development, today announced financial results for the third
quarter ended September 30, 2023 and provided a general business
update.
“The third quarter of 2023 was momentous for Neumora with the
achievement of several important clinical and corporate milestones,
including our successful initial public offering and the initiation
of our Phase 3 KOASTAL program for navacaprant. Additionally, we
are on track to achieve the anticipated milestones for NMRA-511 and
NMRA-266,” said Henry Gosebruch, chief executive officer, Neumora.
“Looking forward, we have a strong balance sheet to support our
continued focus on execution across our programs as we seek to
pioneer a new era in brain diseases, which collectively represent
one of the largest areas of unmet medical need, affecting upwards
of 1.5 billion patients globally. I believe that we have the right
combination of novel programs and capabilities to make a real
difference for patients living with brain diseases and create
significant value.”
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 KOASTAL Program On
TrackNavacaprant (NMRA-140) is a highly selective, novel,
once-daily kappa opioid receptor (KOR) antagonist being developed
as a potential monotherapy treatment for major depressive disorder
(MDD) and other neuropsychiatric disorders.
Neumora initiated the KOASTAL-1 study, a Phase 3 pivotal
clinical trial designed to evaluate the efficacy and safety of
navacaprant monotherapy for the treatment of MDD. This study is
part of Neumora’s registrational Phase 3 KOASTAL program, which
includes the KOASTAL-1, KOASTAL-2, and KOASTAL-3 studies. These
replicate, randomized, placebo-controlled, double-blind studies are
designed to evaluate the efficacy and safety of navacaprant
monotherapy in adult patients with MDD.
The Company expects the following milestones for navacaprant in
MDD:
- Initiate KOASTAL-3 study in the fourth quarter of 2023.
- Initiate KOASTAL-2 study in the first quarter of 2024.
- Report topline data from the KOASTAL-1 study in the second half
of 2024.
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 clinical trial in BPD in the first half of 2024.
BUSINESS UPDATES
- Announced key leadership appointments: In
October 2023, Neumora announced that Robert Lenz, M.D., Ph.D., had
joined Neumora as executive vice president, head of R&D. Dr.
Lenz brings more than two decades of neuroscience drug development
expertise, most recently serving as senior vice president and head
of global development at Amgen.
- Successfully completed initial public
offering: In September 2023, Neumora completed its initial
public offering of its common stock and shares began trading on the
Nasdaq Global Select Market under the ticker symbol “NMRA.” Since
its inception, Neumora has raised over $850 million to further its
mission to confront the global brain disease crisis.
THIRD QUARTER 2023 FINANCIAL RESULTS
The Company reported a net loss of $53.0 million for the third
quarter of 2023, as compared to $29.3 million for the same period
in 2022.
Research and development expenses for the third quarter of 2023
were $41.6 million, as compared to $22.5 million for the same
period in 2022. This increase was primarily due to advancement of
clinical and preclinical programs and related start-up activities
for Phase 3 clinical trials evaluating navacaprant as a monotherapy
treatment for MDD.
General and administrative expenses for the third quarter of
2023 were $15.3 million, as compared to $8.1 million for the same
period in 2022. This increase was primarily due to
personnel-related costs and professional services to support the
continued expansion of administrative functions.
As of September 30, 2023, Neumora had $519.5 million in cash,
cash equivalents and marketable securities. The Company expects
that its cash, cash equivalents and marketable securities as of
September 30, 2023, will enable it to fund its operating plan into
2026.
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; 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 Registration Statement on
Form S-1, as amended (File No. 333-274229), filed with the SEC on
September 11, 2023, and related Prospectus dated September 14, 2023
filed under 424(b)(4) of the Securities Act of 1933, as amended.
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 Statement of
Operations(in thousands, except per-share
data)
|
Three Months
EndedSeptember 30, |
|
Nine Months
EndedSeptember 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
41,601 |
|
|
$ |
22,549 |
|
|
$ |
103,855 |
|
|
$ |
68,226 |
|
Acquired in-process research and development |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
13,000 |
|
General and administrative |
|
15,263 |
|
|
|
8,053 |
|
|
|
34,239 |
|
|
|
23,926 |
|
Total
operating expenses |
|
56,864 |
|
|
|
30,602 |
|
|
|
138,094 |
|
|
|
105,152 |
|
Loss
from operations |
|
(56,864 |
) |
|
|
(30,602 |
) |
|
|
(138,094 |
) |
|
|
(105,152 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
Interest income |
|
3,838 |
|
|
|
1,406 |
|
|
|
10,965 |
|
|
|
2,276 |
|
Other income (expense), net |
|
(1 |
) |
|
|
(148 |
) |
|
|
(66 |
) |
|
|
118 |
|
Total
other income |
|
3,837 |
|
|
|
1,258 |
|
|
|
10,899 |
|
|
|
2,394 |
|
Net
loss |
|
(53,027 |
) |
|
|
(29,344 |
) |
|
|
(127,195 |
) |
|
|
(102,758 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
137 |
|
|
|
(284 |
) |
|
|
463 |
|
|
|
(1,154 |
) |
Comprehensive loss |
$ |
(52,890 |
) |
|
$ |
(29,628 |
) |
|
$ |
(126,732 |
) |
|
$ |
(103,912 |
) |
Net loss
per share, basic and diluted |
$ |
(1.14 |
) |
|
$ |
(1.06 |
) |
|
$ |
(3.59 |
) |
|
$ |
(3.83 |
) |
Weighted-average shares outstanding, basic and diluted |
|
46,691 |
|
|
|
27,646 |
|
|
|
35,428 |
|
|
|
26,841 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neumora Therapeutics,
Inc.Unaudited Consolidated Balance Sheets
(in thousands)
|
September 30,2023 |
|
December 31,2022 |
|
(unaudited) |
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
412,284 |
|
|
$ |
240,943 |
|
Short-term marketable securities |
|
97,281 |
|
|
|
130,941 |
|
Restricted cash |
|
— |
|
|
|
50 |
|
Prepaid expenses and other current assets |
|
16,170 |
|
|
|
16,021 |
|
Total current assets |
|
525,735 |
|
|
|
387,955 |
|
Long-term marketable
securities |
|
9,913 |
|
|
|
23,511 |
|
Property and equipment,
net |
|
1,934 |
|
|
|
2,411 |
|
Operating lease right-of-use
assets |
|
5,954 |
|
|
|
8,231 |
|
Restricted cash |
|
1,213 |
|
|
|
1,213 |
|
Other assets |
|
— |
|
|
|
2,913 |
|
Total assets |
$ |
544,749 |
|
|
$ |
426,234 |
|
Liabilities,
Convertible Preferred Stock, and Stockholders’ Equity
(Deficit) |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,229 |
|
|
$ |
7,147 |
|
Accrued liabilities |
|
23,347 |
|
|
|
11,536 |
|
Early exercise liability, current portion |
|
149 |
|
|
|
1,644 |
|
Operating lease liabilities, current portion |
|
3,398 |
|
|
|
3,370 |
|
Total current liabilities |
|
29,123 |
|
|
|
23,697 |
|
Operating lease liabilities,
net of current portion |
|
2,745 |
|
|
|
5,072 |
|
Early exercise liability, net
of current portion |
|
188 |
|
|
|
628 |
|
Total liabilities |
|
32,056 |
|
|
|
29,397 |
|
Commitments and contingencies
(Note 7) |
|
|
|
Convertible preferred stock |
|
— |
|
|
|
843,687 |
|
Stockholders’ equity (deficit): |
|
|
|
Common stock |
|
15 |
|
|
|
3 |
|
Additional paid-in capital |
|
1,107,693 |
|
|
|
21,430 |
|
Accumulated other comprehensive loss |
|
(311 |
) |
|
|
(774 |
) |
Accumulated deficit |
|
(594,704 |
) |
|
|
(467,509 |
) |
Total
stockholders’ equity (deficit) |
|
512,693 |
|
|
|
(446,850 |
) |
Total
liabilities, convertible preferred stock, and stockholders’ equity
(deficit) |
$ |
544,749 |
|
|
$ |
426,234 |
|
|
|
|
|
|
|
|
|
InvestorsHelen Rubinstein+1 (315)
382-3979Helen.Rubinstein@neumoratx.com
Neumora Therapeutics (NASDAQ:NMRA)
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