NGM Bio Provides Business Highlights and Reports Fourth Quarter and Full Year 2022 Financial Results
28 Fevereiro 2023 - 6:05PM
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 fourth quarter
and full year ended December 31, 2022.
“In 2022, NGM Bio further focused our clinical development
efforts on our portfolio of clinical-stage solid tumor oncology
programs, while continuing the efforts of our prolific drug
discovery engine to produce potential next-generation biologic
therapeutics.” said David J. Woodhouse, Ph.D., Chief Executive
Officer at NGM Bio. “At year end, we reported promising preliminary
data from our first myeloid checkpoint inhibitor program, NGM707,
at the ESMO Immuno-Oncology Congress and advanced our other myeloid
checkpoint inhibitor programs, NGM438 and NGM831, in their ongoing
Phase 1/1b trials in patients with advanced solid tumors.”
Key Fourth Quarter and Recent Highlights
Solid Tumor Oncology
- Presented
preliminary findings from the Phase 1a monotherapy dose escalation
arm of the ongoing Phase 1/2 trial of NGM707, an ILT2/ILT4
antagonist antibody product candidate for the treatment of patients
with advanced or metastatic solid tumors, at the 2022 European
Society of Medical Oncologists Immuno-Oncology (ESMO I-O) Congress.
Preliminary findings indicated that NGM707 was generally well
tolerated across all dose levels and demonstrated early signals of
anti-tumor activity across multiple tumor types.
- Initiated a Phase 1b
cohort of the Phase 1/1b trial evaluating NGM438, a LAIR1
antagonist antibody product candidate, in combination with
pembrolizumab for the treatment of patients with advanced or
metastatic solid tumors.
Other Programs
- Remained on track
for topline data readout of ALPINE 4, the Phase 2b trial of
aldafermin, an engineered FGF19 analog product candidate, in
patients with compensated NASH cirrhosis (F4 NASH) in the second
quarter of 2023.
- Announced that our
Phase 2 CATALINA trial evaluating NGM621, a monoclonal antibody
engineered to potently inhibit complement C3, in patients with
geographic atrophy (GA) secondary to advanced macular degeneration
did not meet its primary endpoint. Merck Sharp & Dohme LLC’s,
or Merck’s, option to license NGM621 and its related compounds
under our amended and restated research collaboration, product
development and license agreement, or the Amended Collaboration
Agreement, expired unexercised in January 2023 and the program is
now wholly owned by us.
- Presented
characterization of our first disclosed preclinical bispecific
program, NGM936, a bispecific T cell engager therapeutic candidate
for the treatment of hematologic malignancies that targets ILT3 and
CD3, at the American Society of Hematology (ASH) Annual
Meeting.
- Received
notification from Merck of its decision to terminate the Phase 2b
trial of MK-3655 (NGM313), an agonistic antibody that selectively
activates fibroblast growth factor receptor 1c-beta-klotho, for the
treatment of patients with NASH and liver fibrosis stage 2 or 3 and
our amended and restated research collaboration, product
development and license agreement as it relates to the MK-3655
(NGM313) and its related compounds. Merck’s decision to discontinue
the trial was based on its interim analysis of reduction in liver
fat at Week 24 and was not related to safety concerns. As a result,
in late April 2023, the license rights granted to Merck in 2018
with respect to MK-3655 (NGM313) and its related compounds will
revert to us and we will wholly own the program.
- Due to the need to
conserve capital and prioritize focused execution, we are actively
seeking, or intend to seek, collaboration, out licensing,
partnering or other business development arrangements with
third-party partners with sufficient resources and relevant domain
expertise in the relevant therapeutic area in order to further
clinical development of the following programs:
- NGM621, a product
candidate designed for the treatment of patients with GA secondary
to advanced macular degeneration;
- Aldafermin, a
product candidate designed for the treatment of patients with NASH
and/or diseases related to bile acid dysregulation;
- MK-3655 (NGM313), a product candidate designed as an insulin
sensitizer for the treatment of patients with NASH, once
termination of Merck’s license is effective; and
- NGM936, a product
candidate designed for the treatment of patients with AML and
multiple myeloma.
Fourth Quarter and Full Year 2022
Financial Results
- NGM Bio reported a
net loss of $36.4 million and $162.7 million for the quarter and
year ended December 31, 2022, respectively, compared to a net
loss of $27.2 million and $120.3 million for the same periods in
2021.
- Related party
revenue from our collaboration with Merck under the Amended
Collaboration Agreement was $18.2 million and $55.3 million for the
quarter and year ended December 31, 2022, respectively,
compared to $21.0 million and $77.9 million for the same periods in
2021. Our related party revenue from Merck decreased substantially
in 2022 and is expected to be significantly lower from January 1,
2023 through March 31, 2024.
- Research and
development (R&D) expenses were $46.7 million and $181.1
million for the quarter and year ended December 31, 2022,
respectively, compared to $38.7 million and $161.7 million for the
same periods in 2021. R&D expenses increased $8.0 million in
the quarter ended December 31, 2022 as compared to the prior year
period and $19.4 million in 2022 as compared to 2021 primarily due
to costs related to our ongoing clinical trials of NGM707, NGM438,
NGM831 and NGM120, our completed Phase 2 trial of NGM621, and
personnel-related expenses, partially offset by decreased expenses
for our manufacturing activities and our clinical trials of
aldafermin.
- General and
administrative expenses were $9.8 million and $40.5 million for the
quarter and year ended December 31, 2022, respectively,
compared to $9.5 million and $36.9 million for the same periods in
2021.
- Cash, cash
equivalents and short-term marketable securities were $271.5
million as of December 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 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., Kenilworth, NJ,
USA.
Abbreviations (in Alphabetical Order)
AML=acute myeloid leukemia; CD3=cluster of differentiation 3;
F4=stage 4 liver fibrosis; FGF19=fibroblast growth factor 19;
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,” “expect,” “potentially,”
“promising,” “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, including identification and engagement of
third-party partners for potential future collaboration, out
licensing, partnering or other business development arrangements
(“BD Arrangements”) with respect to NGM621, aldafermin, NGM936 and,
once termination of Merck’s license is effective, MK-3655 (NGM313),
and research and development and discovery engine output; NGM Bio’s
expectation of providing updates and meeting multiple milestones,
including the availability and anticipated timing of clinical data
readouts from the Phase 2b trial of aldafermin in patients with F4
NASH in the second quarter of 2023; expectation of significantly
lower revenue from Merck; 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 NGM Bio’s need for
additional capital, particularly in light of NGM Bio’s expectation
that Merck will provide significantly lower funding through March
31, 2024 and macroeconomic conditions (such as the impacts of the
ongoing COVID-19 pandemic and the conflict between Russia and
Ukraine, global economic slowdown, increased inflation and rising
interest rates); 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 quarterly report on Form
10-Q for the quarter ended September 30, 2022 filed with the United
States Securities and Exchange Commission (SEC) on November 3, 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 EndedDecember
31, |
|
Year EndedDecember 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021* |
Related party revenue |
$ |
18,181 |
|
|
$ |
20,959 |
|
|
$ |
55,333 |
|
|
$ |
77,882 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
46,722 |
|
|
|
38,729 |
|
|
|
181,067 |
|
|
|
161,712 |
|
General and administrative |
|
9,756 |
|
|
|
9,454 |
|
|
|
40,515 |
|
|
|
36,865 |
|
Total operating expenses |
|
56,478 |
|
|
|
48,183 |
|
|
|
221,582 |
|
|
|
198,577 |
|
Loss from operations |
|
(38,297 |
) |
|
|
(27,224 |
) |
|
|
(166,249 |
) |
|
|
(120,695 |
) |
Interest income, net |
|
2,030 |
|
|
|
85 |
|
|
|
3,714 |
|
|
|
420 |
|
Other expense, net |
|
(170 |
) |
|
|
(95 |
) |
|
|
(132 |
) |
|
|
(60 |
) |
Net loss |
$ |
(36,437 |
) |
|
$ |
(27,234 |
) |
|
$ |
(162,667 |
) |
|
$ |
(120,335 |
) |
Net loss per share, basic and
diluted |
$ |
(0.45 |
) |
|
$ |
(0.35 |
) |
|
$ |
(2.03 |
) |
|
$ |
(1.56 |
) |
Weighted average shares used
to compute net loss per share, basic and diluted |
|
81,787 |
|
|
|
77,779 |
|
|
|
79,950 |
|
|
|
77,085 |
|
___________* Derived from the audited consolidated financial
statements.
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands) (Unaudited)
|
December 31,2022 |
|
December 31,2021* |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
73,456 |
|
|
$ |
151,795 |
|
Short-term marketable securities |
|
198,036 |
|
|
|
214,458 |
|
Related party receivable from collaboration |
|
7,580 |
|
|
|
4,945 |
|
Prepaid expenses and other current assets |
|
9,787 |
|
|
|
8,082 |
|
Total current assets |
|
288,859 |
|
|
|
379,280 |
|
Property and equipment, net |
|
8,496 |
|
|
|
10,071 |
|
Operating lease right-of-use
asset |
|
2,096 |
|
|
|
4,045 |
|
Restricted cash |
|
3,954 |
|
|
|
1,499 |
|
Other non-current assets |
|
3,997 |
|
|
|
7,492 |
|
Total assets |
$ |
307,402 |
|
|
$ |
402,387 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
8,453 |
|
|
$ |
5,246 |
|
Accrued liabilities |
|
33,638 |
|
|
|
33,258 |
|
Operating lease liability, current |
|
5,385 |
|
|
|
5,077 |
|
Contract liabilities |
|
366 |
|
|
|
17,774 |
|
Total current liabilities |
|
47,842 |
|
|
|
61,355 |
|
Operating lease liability,
non-current |
|
— |
|
|
|
5,385 |
|
Total liabilities |
|
47,842 |
|
|
|
66,740 |
|
Commitments and
contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock, $0.001 par
value |
|
— |
|
|
|
— |
|
Common stock, $0.001 par
value |
|
82 |
|
|
|
78 |
|
Additional paid-in capital |
|
841,413 |
|
|
|
754,664 |
|
Accumulated other comprehensive loss |
|
(302 |
) |
|
|
(129 |
) |
Accumulated deficit |
|
(581,633 |
) |
|
|
(418,966 |
) |
Total stockholders' equity |
|
259,560 |
|
|
|
335,647 |
|
Total liabilities and
stockholders' equity |
$ |
307,402 |
|
|
$ |
402,387 |
|
___________* Derived from the audited consolidated financial
statements.
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