NGM Bio Provides Business Highlights and Reports First Quarter 2022 Financial Results
05 Maio 2022 - 5:14PM
NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a
biotechnology company focused on discovering and developing
transformative therapeutics for patients, today provided business
highlights and reported financial results for the quarterly period
ended March 31, 2022.
“We are pleased with the progress that we have made to date in
2022, in particular with our oncology portfolio, including the
advancement of our second myeloid checkpoint inhibitor program,
NGM831, into the clinic,” said David J. Woodhouse, Ph.D., Chief
Executive Officer at NGM Bio. “We plan to deliver several program
updates in the second half of the year with multiple milestones
expected, including topline Phase 2 data from the CATALINA trial
for NGM621, a monoclonal antibody product candidate engineered to
potently inhibit complement C3 for patients with geographic
atrophy, as well as initial interim monotherapy data from the
NGM707 Phase 1 trial and updated data from the Phase 1a/1b trial of
NGM120, an antagonist antibody product candidate that binds GFRAL
and is designed to inhibit GDF15 signaling, both of which we are
developing for the treatment of cancer.”
Key First Quarter and Recent Highlights
Oncology
- Initiated the Phase
1/1b clinical trial of NGM831 as a monotherapy and in combination
with KEYTRUDA for the treatment of patients with advanced solid
tumors.
- Delivered an oral
presentation at the 2022 AACR annual meeting to showcase in vitro
and in vivo research demonstrating potential advantages of dual
ILT2/ILT4 inhibition with NGM707 and late-breaking poster
presentations to highlight preclinical research supporting
development of NGM831 and NGM438.
Retinal Disease
- The U.S. Food and
Drug Administration granted Fast Track designation to NGM621 for
the treatment of patients with geographic atrophy, or GA, secondary
to age-related macular degeneration.
Liver and Metabolic Diseases
- Completed enrollment
in ALPINE 4, the Phase 2b trial of aldafermin, an engineered FGF19
analog product candidate, in patients with compensated NASH
cirrhosis (F4 NASH), in January 2022. A topline data readout for
ALPINE 4 is expected in the first half of 2023.
Corporate Highlights
- Hosted the first two
sessions of a four-part virtual R&D overview event titled the
“Explorer Series” showcasing NGM Bio’s discovery engine and NGM
Bio’s myeloid reprogramming programs, NGM831 and NGM438, both
targeting tumor stromal checkpoints.
First Quarter 2022 Financial Results
- NGM reported a net
loss of $32.5 million for the quarter ended March 31,
2022, compared to a net loss of $27.5 million for the same period
in 2021.
- Related party
revenue from our collaboration with Merck was $20.9 million for the
quarter ended March 31, 2022, compared to $21.6 million for
the same period in 2021.
- R&D expenses
were $42.8 million for the quarter ended March 31, 2022,
compared to $40.7 million for the same period in 2021. R&D
expenses increased $2.1 million in the quarter as compared to the
same period in 2021, primarily due to our ongoing clinical trials
of NGM621, NGM707, NGM831 and NGM120, our preclinical study of
NGM438, and personnel-related expenses partially offset by
decreased expenses for our manufacturing activities and our
clinical trials of aldafermin.
- General and
administrative expenses were $10.7 million for the quarter
ended March 31, 2022, compared to $8.7 million for the
same period in 2021. The $2.0 million increase in general and
administrative expenses in the quarter as compared to the same
period in 2021 was primarily attributable to compensation-related
expenses driven by higher headcount and an increase in expenses
associated with being a public company.
- Cash, cash
equivalents and short-term marketable securities were $329.8
million as of March 31, 2022, compared to $366.3 million as of
December 31, 2021.
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 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, with a disease-agnostic mindset,
always led by biology and motivated by unmet patient need. Today,
the company has seven programs in active development, including
four in Phase 2 or 2b studies, across three therapeutic areas:
cancer, retinal diseases and liver and metabolic diseases. 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.
Abbreviations (in Alphabetical Order)
F4 = stage 4 liver fibrosis; GDF15 = Growth Differentiation
Factor 15; GFRAL=Glial Cell-Derived Neurotrophic Factor Receptor
Alpha-Like; 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,” “may,” “expect,” “engineered to,”
“designed to,” “potential,” “promising,” “plan,” “aspires,” “aims”
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 and
research and development output; NGM Bio’s expectation of providing
updates and meeting multiple milestones, including clinical data
readouts from three of its programs in 2022; the availability and
anticipated timing of a topline data readout for ALPINE 4, the
Phase 2b trial of aldafermin; 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, including 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 clinical trials to date may not be indicative of
results obtained in ongoing or future trials and that NGM Bio’s
product candidates may otherwise not be tolerable and effective
treatments in their planned indications; NGM Bio’s ability to
maintain its amended collaboration with Merck, including the risk
that if Merck were to breach or terminate the amended collaboration
or Merck’s development funding obligations, NGM Bio would not
obtain all of the anticipated financial and other benefits of the
amended collaboration, and the development and/or commercialization
of NGM Bio’s product candidates within the scope of the amended
collaboration could be delayed, perhaps substantially; the ongoing
COVID-19 pandemic, which has adversely affected, and could
materially and adversely affect in the future, NGM Bio’s business
and operations, including NGM Bio’s ability to timely supply,
initiate, enroll and complete its ongoing and future clinical
trials; the time-consuming and uncertain regulatory approval
process; NGM Bio’s reliance on third-party manufacturers for
aldafermin, NGM120, NGM707, NGM831, NGM438, NGM621 and its other
product candidates and the risks inherent in manufacturing and
testing pharmaceutical products; the sufficiency of NGM Bio’s cash
resources, including to fund its wholly-owned programs, and NGM
Bio’s need for additional capital; 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, 2021 filed with the United States Securities and Exchange
Commission (SEC) on March 1, 2022 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:Brian
Schoelkopfir@ngmbio.com |
Media Contact:media@ngmbio.com |
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except per share
amounts)(Unaudited)
|
Three Months Ended March
31, |
|
2022 |
|
2021 |
Related party revenue |
$ |
20,948 |
|
|
$ |
21,575 |
|
Operating expenses: |
|
|
|
Research and development |
|
42,806 |
|
|
|
40,699 |
|
General and administrative |
|
10,723 |
|
|
|
8,721 |
|
Total operating expenses |
|
53,529 |
|
|
|
49,420 |
|
Loss from operations |
|
(32,581 |
) |
|
|
(27,845 |
) |
Interest income, net |
|
176 |
|
|
|
114 |
|
Other (expense) income, net |
|
(45 |
) |
|
|
187 |
|
Net loss |
$ |
(32,450 |
) |
|
$ |
(27,544 |
) |
Net loss per share, basic and
diluted |
$ |
(0.42 |
) |
|
$ |
(0.36 |
) |
Weighted average shares used
to compute net loss per share, basic and diluted |
|
78,023 |
|
|
|
76,034 |
|
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands, except per
share
amounts) (Unaudited)
|
March 31, 2022 |
|
December 31, 2021* |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
109,872 |
|
|
$ |
151,795 |
|
Short-term marketable securities |
|
219,960 |
|
|
|
214,458 |
|
Related party receivable from collaboration |
|
103 |
|
|
|
4,945 |
|
Prepaid expenses and other current assets |
|
7,687 |
|
|
|
8,082 |
|
Total current assets |
|
337,622 |
|
|
|
379,280 |
|
Property and equipment, net |
|
9,436 |
|
|
|
10,071 |
|
Operating lease right-of-use
asset |
|
3,570 |
|
|
|
4,045 |
|
Restricted cash |
|
1,499 |
|
|
|
1,499 |
|
Other non-current assets |
|
7,646 |
|
|
|
7,492 |
|
Total assets |
$ |
359,773 |
|
|
$ |
402,387 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
4,815 |
|
|
$ |
5,246 |
|
Accrued liabilities |
|
29,478 |
|
|
|
33,258 |
|
Operating lease liability, current |
|
5,153 |
|
|
|
5,077 |
|
Contract liabilities |
|
5,117 |
|
|
|
17,774 |
|
Total current liabilities |
|
44,563 |
|
|
|
61,355 |
|
Operating lease liability,
non-current |
|
4,073 |
|
|
|
5,385 |
|
Total liabilities |
|
48,636 |
|
|
|
66,740 |
|
Commitments and
contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, $0.001 par
value; |
|
— |
|
|
|
— |
|
Common stock, $0.001 par
value; |
|
78 |
|
|
|
78 |
|
Additional paid-in capital |
|
763,152 |
|
|
|
754,664 |
|
Accumulated other comprehensive loss |
|
(677 |
) |
|
|
(129 |
) |
Accumulated deficit |
|
(451,416 |
) |
|
|
(418,966 |
) |
Total stockholders' equity |
|
311,137 |
|
|
|
335,647 |
|
Total liabilities and
stockholders' equity |
$ |
359,773 |
|
|
$ |
402,387 |
|
___________* Derived from the audited consolidated financial
statements.
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