NGM Bio Reports First Quarter 2023 Financial Results and Provides Business Highlights, Including Topline ALPINE 4 Data
04 Maio 2023 - 5:05PM
NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a
clinical-stage biotechnology company focused on discovering and
developing transformative therapeutics for patients, today reported
financial results for the quarterly period ended March 31,
2023 and provided business highlights.
“We are pleased with the results of the ALPINE 4
trial supporting the therapeutic potential of aldafermin in
patients with advanced NASH. We continue to make progress on our
corporate strategy with the initiation of Phase 2 expansion cohorts
in our proof-of-concept trial of NGM707 and the extension of our
expected cash runway. With these activities, we are optimizing our
resource allocation strategy towards advancing our solid tumor
oncology portfolio in the clinic, while our discovery engine
continues to generate new product candidates,” said David J.
Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. “I would like
to extend my sincere gratitude and thanks to NGM Bio’s departing
staff impacted by our recent restructuring for their significant
contributions and unwavering commitment to discovering and
developing novel, life-changing medicines for people whose health
and lives are disrupted by disease.”
Key First Quarter and
Recent Highlights
Corporate Updates
-
Announced the appointment of Dan Kaplan, Ph.D. to Chief Scientific
Officer. Dr Kaplan has been a member of NGM Bio’s Research and
Development organization for fourteen years, most recently as Vice
President, Immuno-oncology. Jin-Long Chen, Ph.D., who founded NGM
Bio and served as Chief Scientific Officer and as a member of NGM
Bio’s Board of Directors, resigned from NGM Bio effective April 4,
2023.
-
Announced a restructuring resulting in a reduction of NGM Bio’s
workforce by 75 people, or approximately 33% of the
pre-restructuring headcount. NGM Bio expects to incur approximately
$5.0 million in charges in connection with the restructuring, the
majority to be incurred in the second quarter. The execution of the
restructuring, including cash payments, will be substantially
complete by the end of the second quarter.
Solid Tumor Oncology
-
Initiated the first two Phase 2b cohorts in the Phase 1/2 trial
evaluating NGM707 in combination with pembrolizumab.
-
Continued enrollment in the Phase 1/1b trial evaluating NGM438, a
LAIR1 antagonist antibody product candidate, as a monotherapy and
in combination with pembrolizumab for the treatment of patients
with advanced or metastatic solid tumors.
-
Continued enrollment in the Phase 1/1b trial evaluating NGM831, an
ILT3 antagonist antibody product candidate, as a monotherapy and in
combination with pembrolizumab for the treatment of patients with
advanced or metastatic solid tumors.
Phase 2b ALPINE 4 Trial Topline Results
-
Today NGM Bio is reporting topline data from the Phase 2b ALPINE 4
trial of aldafermin in 160 patients with compensated cirrhosis due
to NASH (liver fibrosis stage 4, or, F4). The 48-week trial
assessed the efficacy, safety and tolerability of 1 mg and 3 mg
doses of aldafermin compared to placebo1.
- The study met its primary endpoint
with a statistically significant reduction in ELF score from
baseline to week 48 in patients treated with 3 mg of aldafermin
versus patients receiving placebo. Patients receiving 3 mg of
aldafermin had a 0.5 point greater reduction in ELF at week 48
compared to patients receiving placebo (p-value = 0.0003). The ELF
score is a reproducible, quantitative non-invasive liver prognostic
test that evaluates liver fibrosis and correlates to liver-related
outcomes.
-
On the secondary endpoint of fibrosis improvement of ≥1 stage (for
which the trial was not statistically powered) 21% (p-value=0.39)
and 23% (p-value=0.36) of patients in the 1 mg and 3 mg cohorts,
respectively, achieved fibrosis improvement versus 15% in the
placebo cohort.
-
Aldafermin was generally well tolerated with no treatment-related
serious adverse events and a safety and tolerability profile
generally consistent with prior trials of aldafermin, including
higher levels of gastrointestinal events in patients treated with
aldafermin as compared to patients treated with placebo.
“On behalf of the entire NGM Bio team, I’d like
to thank the ALPINE 4 investigators and clinical trial staff, our
employees who contributed to this effort and, most importantly, the
patients who participated in the study,” said Hsiao D. Lieu, M.D.,
Chief Medical Officer at NGM Bio. “We are encouraged that we
continue to see evidence of the potential therapeutic activity of
aldafermin, including on the ELF biomarker that has been correlated
to patient outcomes, and we look forward to having conversations
with potential partners to determine further development of the
program.”
First Quarter 2023 Financial
Results
-
NGM Bio reported a net loss of $47.6 million for the quarter
ended March 31, 2023, compared to a net loss of $32.5 million
for the same period in 2022.
-
Related party revenue from our collaboration with Merck Sharp &
Dohme LLC, or Merck, was $2.2 million for the quarter ended
March 31, 2023, compared to $20.9 million for the same period
in 2022. Our related party revenue from Merck decreased
substantially after March 2022 and is expected to continue to
decrease in 2023.
-
R&D expenses were $40.9 million for the quarter ended
March 31, 2023, compared to $42.8 million for the same
period in 2022.
-
General and administrative expenses were $11.6 million for the
quarter ended March 31, 2023, compared to $10.7 million
for the same period in 2022.
-
Cash, cash equivalents and short-term marketable securities were
$231.0 million as of March 31, 2023, compared to $271.5
million as of December 31, 2022. NGM Bio expects its cash,
cash equivalents and marketable securities will be sufficient to
fund its planned operations into the second quarter of 2025. NGM
Bio has based this estimate on plans and assumptions that may prove
to be insufficient or inaccurate (for example, with respect to
anticipated costs, timing or success of certain activities), and
the company could utilize its available financial resources sooner
than it currently expects.
About NGM Biopharmaceuticals, Inc.
NGM Bio is focused on discovering and developing
novel, life-changing medicines for people whose health and lives
have been disrupted by disease. The company’s biology-centric drug
discovery approach aims to seamlessly integrate interrogation of
complex disease-associated biology and protein engineering
expertise to unlock proprietary insights that are leveraged to
generate promising product candidates and enable their rapid
advancement into proof-of-concept studies. As explorers on the
frontier of life-changing science, NGM Bio aspires to operate one
of the most productive research and development engines in the
biopharmaceutical industry. All therapeutic candidates in the NGM
Bio pipeline have been generated by its in-house discovery engine,
always led by biology and motivated by unmet patient need. Today,
the company has four solid tumor oncology programs in clinical
development. Visit us at www.ngmbio.com for more information.
KEYTRUDA® is a registered trademark of Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.
1 A 0.3 mg aldafermin cohort was part of the
original design of the trial and enrolled 7 patients prior to being
discontinued in favor of enrolling more patients in the 1 mg and 3
mg arms of the trial. Patients in the 0.3 mg arm were primarily
evaluated for safety.
Abbreviations (in Alphabetical
Order)
F4=Stage 4 Liver Fibrosis;
ILT2=Immunoglobin-Like Transcript 2; ILT3=Immunoglobin-Like
Transcript 3; ILT4=Immunoglobin-Like Transcript 4;
LAIR1=Leukocyte-Associated Immunoglobulin-Like Receptor 1;
NASH=non-alcoholic steatohepatitis
Forward-Looking Statements
Statements contained in this press release
regarding matters that are not historical facts are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Words such as “will,”
“could,” “expect,” “expected,” “potential,” “promising,” “aspires,”
“aims,” “look forward to” and similar expressions (as well as other
words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
These statements include those related to: the therapeutic
potential of NGM Bio’s product candidates; NGM Bio’s continued
pipeline development, including identification and engagement of
third-party partners for potential future business development
arrangements (“BD Arrangements”) to determine further development
of aldafermin, and research and development and discovery engine
output; NGM Bio’s expectation of continued decreasing revenue from
Merck; the costs, timing and financial impact of the restructuring;
NGM Bio extending its expected cash runway and the timing thereof;
and other statements that are not historical fact. Because such
statements deal with future events and are based on NGM Bio’s
current expectations, they are subject to various risks and
uncertainties, and actual results, performance or achievements of
NGM Bio could differ materially from those described in or implied
by the statements in this press release. These forward-looking
statements are subject to risks and uncertainties, including,
without limitation, risks and uncertainties associated with the
costly and time-consuming pharmaceutical product development
process and the uncertainty of clinical success; risks related to
failure or delays in successfully initiating, enrolling, reporting
data from or completing clinical studies, as well as the risks that
results obtained in preclinical or clinical trials to date may not
be indicative of results obtained in future trials; NGM Bio’s
reliance on its amended collaboration with Merck; NGM Bio’s ability
to identify and engage third-party partners for BD Arrangements, if
any, and its ability to attract such partners; the time-consuming
and uncertain regulatory approval process; NGM Bio’s reliance on
third-party manufacturers for its product candidates and the risks
inherent in manufacturing and testing pharmaceutical products; the
sufficiency of NGM Bio’s cash resources and expected cash runway,
including the risk that NGM Bio could utilize its available capital
resources sooner than it currently expects and its need for
additional capital; macroeconomic conditions (such as the impacts
of the ongoing COVID-19 pandemic and the conflict between Russia
and Ukraine, global economic slowdown, increased inflation, rising
interest rates and recent and potential future bank failures); and
other risks and uncertainties affecting NGM Bio and its development
programs, including those discussed in the section titled “Risk
Factors” in NGM Bio’s Annual Report on Form 10-K for the year ended
December 31, 2022 filed with the United States Securities and
Exchange Commission (“SEC”) on February 28, 2023 and future filings
and reports that NGM Bio makes from time to time with the SEC.
Except as required by law, NGM Bio assumes no obligation to update
these forward-looking statements, or to update the reasons if
actual results differ materially from those anticipated in the
forward-looking statements.
Investor Contact:ir@ngmbio.com |
Media Contact:media@ngmbio.com |
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except per share
amounts)(Unaudited)
|
Three Months EndedMarch 31, |
|
2023 |
|
2022 |
Related party revenue |
$ |
2,247 |
|
|
$ |
20,948 |
|
Operating expenses: |
|
|
|
Research and development |
|
40,857 |
|
|
|
42,806 |
|
General and administrative |
|
11,584 |
|
|
|
10,723 |
|
Total operating expenses |
|
52,441 |
|
|
|
53,529 |
|
Loss from operations |
|
(50,194 |
) |
|
|
(32,581 |
) |
Interest income, net |
|
2,584 |
|
|
|
176 |
|
Other expense, net |
|
(37 |
) |
|
|
(45 |
) |
Net loss |
$ |
(47,647 |
) |
|
$ |
(32,450 |
) |
Net loss per share, basic and
diluted |
$ |
(0.58 |
) |
|
$ |
(0.42 |
) |
Weighted average shares used
to compute net loss per share, basic and diluted |
|
82,008 |
|
|
|
78,023 |
|
|
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands, except per
share
amounts) (Unaudited)
|
March 31,2023 |
|
December 31,2022* |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
67,549 |
|
|
$ |
73,456 |
|
Short-term marketable securities |
|
163,455 |
|
|
|
198,036 |
|
Related party receivable from collaboration |
|
1,257 |
|
|
|
7,580 |
|
Prepaid expenses and other current assets |
|
8,769 |
|
|
|
9,787 |
|
Restricted cash |
|
1,499 |
|
|
|
— |
|
Total current assets |
|
242,529 |
|
|
|
288,859 |
|
Property and equipment, net |
|
7,966 |
|
|
|
8,496 |
|
Operating lease right-of-use
asset |
|
1,586 |
|
|
|
2,096 |
|
Restricted cash |
|
2,455 |
|
|
|
3,954 |
|
Other non-current assets |
|
4,301 |
|
|
|
3,997 |
|
Total assets |
$ |
258,837 |
|
|
$ |
307,402 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
13,293 |
|
|
$ |
8,453 |
|
Accrued liabilities |
|
20,161 |
|
|
|
33,638 |
|
Operating lease liability, current |
|
4,073 |
|
|
|
5,385 |
|
Contract liabilities |
|
376 |
|
|
|
366 |
|
Total current liabilities |
|
37,903 |
|
|
|
47,842 |
|
Total liabilities |
|
37,903 |
|
|
|
47,842 |
|
Commitments and
contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, $0.001 par
value |
|
— |
|
|
|
— |
|
Common stock, $0.001 par
value |
|
82 |
|
|
|
82 |
|
Additional paid-in capital |
|
850,229 |
|
|
|
841,413 |
|
Accumulated other comprehensive loss |
|
(97 |
) |
|
|
(302 |
) |
Accumulated deficit |
|
(629,280 |
) |
|
|
(581,633 |
) |
Total stockholders' equity |
|
220,934 |
|
|
|
259,560 |
|
Total liabilities and
stockholders' equity |
$ |
258,837 |
|
|
$ |
307,402 |
|
___________ *
Derived from the audited consolidated financial
statements.
NGM Biopharmaceuticals (NASDAQ:NGM)
Gráfico Histórico do Ativo
De Set 2024 até Out 2024
NGM Biopharmaceuticals (NASDAQ:NGM)
Gráfico Histórico do Ativo
De Out 2023 até Out 2024