NGM Bio Reports Second Quarter 2023 Financial Results and Provides Business Highlights
03 Août 2023 - 10:01PM
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 June 30, 2023
and provided business highlights.
“We continue to make steady progress in clinical
trials of our lead solid tumor oncology programs NGM707, NGM438 and
NGM831,” said David J. Woodhouse, Ph.D., Chief Executive Officer at
NGM Bio. “We also announced positive data in the second quarter
from a Phase 2 investigator-sponsored trial of aldafermin for the
treatment of patients with IBS-D and BAM, and from a Phase 2b trial
of aldafermin in compensated cirrhosis (F4) patients, furthering
our belief in the therapeutic potential of aldafermin. These latest
data deepen the strong body of clinical evidence we have amassed
demonstrating the activity and safety of aldafermin, which we will
leverage as we engage in potential partnering discussions for
continued development of this product candidate.”
Key Second
Quarter and Recent Highlights
Aldafermin
- Announced positive data from Phase 2 investigator-sponsored
trial of aldafermin for the treatment of patients with
diarrhea-predominant IBS-D and BAM in May 2023 at Digestive Disease
Week 2023. Aldafermin demonstrated statistically significant
reductions in serum 7αC4 (a marker of bile acid synthesis) and
fecal bile acids versus placebo in patients with idiopathic BAM
with IBS-D.
- Announced positive 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) in May 2023. The study met
its primary endpoint with a statistically significant reduction in
Enhanced Liver Fibrosis, or ELF, score from baseline to week 48 in
patients treated with 3 mg of aldafermin versus patients receiving
placebo. 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.
Solid Tumor Oncology
- Following the initiation of the first two Phase 2b expansion
cohorts, continued enrollment in the Phase 1/2 trial evaluating
NGM707, an ILT2/ILT4 antagonist antibody product candidate, in
combination with KEYTRUDA® (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.
Corporate Updates
- Announced Siobhan Nolan Mangini will step down as President and
Chief Financial Officer at NGM Bio. To support a smooth transition,
she will stay on until December 1, 2023. NGM Bio has initiated a
search to identify the company's next Chief Financial Officer.
- Substantially completed activities related to the restructuring
of NGM Bio’s workforce announced in April 2023. NGM Bio incurred
restructuring charges of approximately $5.0 million, the majority
of which were paid in the second quarter.
Second Quarter 2023
Financial Results
- NGM Bio reported a net loss of $38.3 million for the
quarter ended June 30, 2023, compared to a net loss of $46.5
million for the same period in 2022.
- Related party revenue from our collaboration with Merck Sharp
& Dohme LLC, or Merck, was $1.4 million for the quarter ended
June 30, 2023 compared to $8.3 million for the same period in
2022. Our related party revenue from Merck will continue to
decrease in 2023 and we expect approximately $0.6 million of
funding from Merck from July 1, 2023 through March 31, 2024.
- R&D expenses were $32.4 million for the quarter ended
June 30, 2023, compared to $45.4 million for the same
period in 2022. R&D expenses included restructuring charges of
$3.9 million in the three and six months ended June 30, 2023.
- General and administrative expenses were $9.6 million for
the quarter ended June 30, 2023, compared to $9.9 million
for the same period in 2022. G&A expenses included
restructuring charges of $1.1 million in the three and six months
ended June 30, 2023.
- Cash, cash equivalents and short-term marketable securities
were $193.5 million as of June 30, 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. 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)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
StatementsStatements 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” 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 programs
currently without significant resource allocation, including
NGM621, aldafermin, NGM313 (MK-3655) and NGM936, and research and
development and discovery engine output; NGM Bio’s expectation of
continued decreasing revenue from Merck; the costs and financial
impact of the restructuring; NGM Bio remaining an integrated
research and development organization following the completion of
the restructuring; the sufficiency of NGM Bio’s cash resources to
fund its planned operations into the second quarter of 2025; 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 Quarterly Report on Form 10-Q for the quarter
ended March 31, 2023 filed with the United States Securities and
Exchange Commission (“SEC”) on May 4, 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 EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
| Related party revenue |
$ |
1,423 |
|
|
$ |
8,293 |
|
|
$ |
3,670 |
|
|
$ |
29,241 |
|
| Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
32,351 |
|
|
|
45,433 |
|
|
|
73,208 |
|
|
|
88,239 |
|
|
General and administrative |
|
9,647 |
|
|
|
9,927 |
|
|
|
21,231 |
|
|
|
20,650 |
|
|
Total operating expenses |
|
41,998 |
|
|
|
55,360 |
|
|
|
94,439 |
|
|
|
108,889 |
|
| Loss from operations |
|
(40,575 |
) |
|
|
(47,067 |
) |
|
|
(90,769 |
) |
|
|
(79,648 |
) |
| Interest income, net |
|
2,448 |
|
|
|
543 |
|
|
|
5,032 |
|
|
|
719 |
|
| Other (expense) income, net |
|
(134 |
) |
|
|
5 |
|
|
|
(171 |
) |
|
|
(40 |
) |
| Net loss |
$ |
(38,261 |
) |
|
$ |
(46,519 |
) |
|
$ |
(85,908 |
) |
|
$ |
(78,969 |
) |
| Net loss per share, basic and
diluted |
$ |
(0.46 |
) |
|
$ |
(0.59 |
) |
|
$ |
(1.04 |
) |
|
$ |
(1.00 |
) |
| Weighted average shares used
to compute net loss per share, basic and diluted |
|
82,456 |
|
|
|
79,270 |
|
|
|
82,233 |
|
|
|
78,650 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands, except per
share
amounts) (Unaudited)
| |
|
|
|
| |
June 30,2023 |
|
December 31,2022* |
|
ASSETS |
|
|
|
| Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
53,271 |
|
|
$ |
73,456 |
|
|
Short-term marketable securities |
|
140,273 |
|
|
|
198,036 |
|
|
Related party receivable from collaboration |
|
736 |
|
|
|
7,580 |
|
|
Prepaid expenses and other current assets |
|
8,623 |
|
|
|
9,787 |
|
|
Restricted cash |
|
1,499 |
|
|
|
— |
|
|
Total current assets |
|
204,402 |
|
|
|
288,859 |
|
| Property and equipment, net |
|
7,760 |
|
|
|
8,496 |
|
| Operating lease right-of-use
asset |
|
1,067 |
|
|
|
2,096 |
|
| Restricted cash |
|
2,455 |
|
|
|
3,954 |
|
| Other non-current assets |
|
4,860 |
|
|
|
3,997 |
|
| Total assets |
$ |
220,544 |
|
|
$ |
307,402 |
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
| Current liabilities: |
|
|
|
|
Accounts payable |
$ |
5,855 |
|
|
$ |
8,453 |
|
|
Accrued liabilities |
|
19,128 |
|
|
|
33,638 |
|
|
Operating lease liability, current |
|
2,751 |
|
|
|
5,385 |
|
|
Contract liabilities |
|
689 |
|
|
|
366 |
|
|
Total current liabilities |
|
28,423 |
|
|
|
47,842 |
|
| Total liabilities |
|
28,423 |
|
|
|
47,842 |
|
| Commitments and
contingencies |
|
|
|
| Stockholders' equity: |
|
|
|
| Preferred stock, $0.001 par
value |
|
— |
|
|
|
— |
|
| Common stock, $0.001 par
value |
|
83 |
|
|
|
82 |
|
|
Additional paid-in capital |
|
859,728 |
|
|
|
841,413 |
|
|
Accumulated other comprehensive loss |
|
(149 |
) |
|
|
(302 |
) |
|
Accumulated deficit |
|
(667,541 |
) |
|
|
(581,633 |
) |
| Total stockholders' equity |
|
192,121 |
|
|
|
259,560 |
|
| Total liabilities and
stockholders' equity |
$ |
220,544 |
|
|
$ |
307,402 |
|
____________________* Derived from the audited
consolidated financial statements.
NGM Biopharmaceuticals (NASDAQ:NGM)
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