NGM Bio Provides Recent Business Highlights and Reports Fourth Quarter and Full Year 2023 Financial Results
March 11 2024 - 3:05PM
NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a
biotechnology company focused on discovering and developing
transformative therapeutics for patients, today provided recent
business highlights and reported financial results for the fourth
quarter and full year ended December 31, 2023.
“In 2023, we made significant progress in patient enrollment in
trials of our solid tumor drug candidates. Most notably, we are
encouraged by the signals of activity observed in our NGM707 Phase
1b trial, particularly among MSS CRC patients whose lesions are
typically unresponsive to immuno-checkpoint therapies. We also made
progress in our discussions with the FDA regarding the design of a
potential registrational Phase 2 study of aldafermin in PSC using a
primary endpoint composed of surrogate biomarkers of PSC
progression and obtained orphan drug designation from the agency
for aldafermin for the treatment of PSC,” said David J. Woodhouse,
Ph.D., Chief Executive Officer at NGM Bio. “In 2024, we are focused
on completing patient enrollment for NGM707 with a potential
interim Phase 1b trial readout in the middle of the year,
initiating a potential Phase 2 proof-of-concept trial of NGM120 in
HG by the end of 2024, and, provided we have the financial
resources and agreement on trial design, initiating a
registrational Phase 2 trial of aldafermin in PSC patients. Our
priority remains to seek licensing and other business development
partners across all our wholly-owned product candidates and to
allocate our resources to the programs that we believe have the
greatest potential both in the near- and long-term.”
Key Fourth Quarter and Recent Highlights
Solid Tumor Oncology
- Disclosed in January 2024 encouraging findings in a Phase 1
Part 1b cohort of the ongoing Phase 1/2 trial evaluating NGM707 in
combination with pembrolizumab for the treatment of patients with
advanced or metastatic solid tumors, including MSS CRC patients. 46
patients were enrolled as of the November 6, 2023 data-cutoff and,
of the 37 response-evaluable patients (those completing at least
one on-treatment scan), there were four confirmed partial responses
across multiple indications, including one pathological complete
response, and 12 patients with stable disease (11% overall response
rate and 43% disease control rate). The combination of NGM707 and
pembrolizumab was generally well-tolerated at all four doses (200,
600, 1200, 1800 mg) of NGM707. The maximum tolerated dose was not
reached. NGM Bio expects to complete enrollment in the Phase 1 Part
1b cohort in the second quarter of 2024 and anticipates providing
an update in mid-2024 on the fully enrolled cohort and subsequent
next steps, including, provided sufficient financial resources, the
potential for additional cohorts, which NGM Bio expects will
include MSS CRC patients.
- Completed enrollment
in the Phase 1 Part 1b cohorts of the Phase 1/1b trials evaluating
NGM831, an ILT3 antagonist antibody product candidate, and NGM438,
a LAIR1 antagonist antibody product candidate, in combination with
pembrolizumab in patients with advanced solid tumors. NGM831 and
NGM438, alone and in combination with pembrolizumab, have been
generally well-tolerated and there have been no dose limiting
toxicities noted to date.
- Initiated an ongoing
Phase 1, Part 1c dose finding cohort evaluating the triplet
combination of NGM831, NGM438 and pembrolizumab. This cohort is
anticipated to complete enrollment in the first half of 2024.
Hyperemesis Gravidarum
- Announced in January
2024 potential development of NGM120 for the treatment of HG.
NGM120, a GFRAL antagonist antibody, is designed to block GDF15
signaling, the central cause of HG and, thereby, may potentially
have therapeutic benefit for treating pregnant women suffering from
HG. HG is a rare, serious condition that affects approximately
100,000 – 150,000 women in the United States each year during
pregnancy and is characterized by intractable nausea and vomiting,
which then results in dehydration, weight loss and malnutrition. HG
has a significant physical and psychosocial impact on patients and
leads to overall higher rates of fetal loss, preeclampsia, preterm
birth, low birth weight and fetal malnutrition. HG is the second
leading cause of hospitalization in pregnancy (second to preterm
labor) and typically recurs in subsequent pregnancies. There are
currently no FDA-approved therapies for this condition. Research1
has shown that GDF15 levels increase steadily in early pregnancy
and, on average, are higher in women who experience nausea and
vomiting in pregnancy and HG. The research also indicated that
women with GDF15 genetic variants associated with lower levels of
GDF15 in a non-pregnant state are predisposed to HG.
- NGM Bio’s goal is to
initiate a Phase 2 proof-of-concept study of NGM120 for the
treatment of HG by the end of 2024. NGM Bio is in the process of
producing a toxicology package to submit to regulatory authorities
in Australia or the United Kingdom that we hope will support
initiation of the trial.
Aldafermin
- Presented positive
Phase 2b results from the ALPINE 4 trial of aldafermin in
compensated cirrhosis (F4) due to NASH at AASLD The Liver Meeting
in November 2023.
- In January 2024,
announced U.S. Food and Drug Administration (FDA) granted orphan
drug designation to aldafermin, an engineered FGF19 analog, for the
treatment of PSC.
- NGM Bio plans to
further develop aldafermin for the treatment of PSC, a rare liver
disease that irreparably damages the bile ducts, leading to bile
acid dysregulation, which, ultimately, results in serious liver
damage. There are currently no FDA-approved therapies for PSC. NGM
Bio is continuing discussions with the FDA regarding the design of
a potential registrational trial of aldafermin in PSC, including on
the proposed utilization of a primary endpoint composed of
surrogate biomarkers with the goal of obtaining accelerated
approval from the FDA. NGM Bio plans to continue working towards
the goal of initiating a potential registrational trial contingent
upon further discussion with the FDA on trial design and obtaining
the additional capital necessary to conduct the study.
Corporate
- On February 26, 2024, NGM Bio announced that it had entered
into the Agreement and Plan of Merger (Merger Agreement) with Atlas
Neon Parent, Inc. (Parent) and Atlas Neon Merger Sub, Inc., a
wholly-owned subsidiary of Parent (Merger Sub). The Merger
Agreement provides for, among other things, (i) the acquisition of
NGM Bio by Parent through a cash tender offer (the Offer) by Merger
Sub for each issued and outstanding share of NGM Bio’s common stock
(other than certain rollover shares) for $1.55 per share (the Offer
Price), and (ii) the merger of Merger Sub with and into NGM Bio
(the Merger), with NGM Bio surviving the Merger as a privately held
company. Subject to the terms of the Merger Agreement, the Offer
Price will be paid subject to any applicable tax withholding and
without interest. Pursuant to the Merger Agreement, on March 8,
2024, Parent commenced the Offer. Additional details can be found
in NGM Bio’s recent filings with the United States Securities and
Exchange Commission (SEC).
- NGM Bio anticipates
that the Offer and the Merger contemplated under the Merger
Agreement will be consummated in the second quarter of 2024.
However, closing of the Merger is subject to customary closing
conditions, and there can be no assurance that the Offer and the
Merger contemplated by the Merger Agreement will be completed. If
the Merger is effected, NGM Bio’s common stock will be delisted
from The Nasdaq Stock Market LLC and NGM Bio will be privately
held.
Fourth Quarter and Full Year 2023
Financial Results
- NGM Bio reported a
net loss of $27.7 million and $142.4 million for the quarter and
year ended December 31, 2023, respectively, compared to a net
loss of $36.4 million and $162.7 million for the same periods in
2022.
- Related party
revenue from the collaboration with Merck Sharp & Dohme LLC, or
Merck, was $0.2 million and $4.4 million for the quarter and year
ended December 31, 2023, respectively, compared to $18.2
million and $55.3 million for the same periods in 2022. The
collaboration with Merck ends on March 31, 2024.
- Research and
development expenses were $21.9 million and $118.0 million for the
quarter and year ended December 31, 2023, respectively,
compared to $46.7 million and $181.1 million for the same periods
in 2022.
- General and
administrative expenses were $7.9 million and $37.8 million for the
quarter and year ended December 31, 2023, respectively,
compared to $9.8 million and $40.5 million for the same periods in
2022.
- Cash, cash
equivalents and short-term marketable securities were $144.2
million as of December 31, 2023.
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)
F4=fibrosis stage 4; FGF19=fibroblast growth factor 19;
GDF15=growth differentiation factor 15; GFRAL=glial cell-derived
neurotrophic factor receptor alpha-like; HG=hyperemesis gravidarum;
NASH=nonalcoholic steatohepatitis; ILT2=immunoglobin-like
transcript 2; ILT3=immunoglobin-like transcript 3;
ILT4=immunoglobin-like transcript 4; LAIR1=leukocyte-associated
immunoglobulin-like receptor 1
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 “encouraged”, “will,” “could,” “expect,”
“expected,” “promising,” “aspires,” “aims,” “hope” 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, or the BD Arrangements,
across all NGM Bio’s wholly-owned product candidates and to
allocate its resources to the programs that it believes have the
greatest potential both in the near- and long-term and; research
and development and discovery engine output; the expected timing of
completion of enrollment of NGM Bio’s ongoing Phase 1 Part 1b
cohort of the Phase1/2 trial of NGM707 in combination with
KEYTRUDA® (pembrolizumab) and timing of anticipated updates on the
completed cohort and subsequent next steps, including the potential
for additional cohorts; timing of the potential start of NGM120 in
a proof-of-concept study for the treatment of HG; the design and
initiation of a potential registrational trial for aldafermin for
the treatment of PSC using surrogate endpoints; timing of
completion of enrollment of NGM Bio’s ongoing Phase 1, Part 1c dose
finding cohort evaluating the triplet combination of NGM831, NGM438
and pembrolizumab; the potential therapeutic benefit of NGM120 for
treating pregnant women suffering from HG; the ability of NGM Bio
and Atlas Neon Parent, Inc., a Delaware corporation (Parent), and
Atlas Neon Merger Sub, Inc., a Delaware corporation and a
wholly-owned subsidiary of Parent (together with Parent, the
Purchaser) to complete the transactions contemplated by the Merger
Agreement, including the parties’ ability to satisfy the conditions
to the consummation of the Offer and the other conditions set forth
in the Merger Agreement, statements about the expected timetable
for completing the transactions, NGM Bio’s and Purchaser’s beliefs
and expectations and statements about the benefits sought to be
achieved by Purchaser’s proposed acquisition of NGM Bio, the
possibility of any termination of the Merger Agreement, estimates
relating to NGM Bio’s past, current or future financial condition;
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; the lack of
regulatory clarity regarding acceptable surrogate endpoints for PSC
and related development uncertainty; the vulnerable patient
population experiencing HG and risks associated with clinical
trials on such patient population; uncertainties inherent in the
preclinical development process of NGM120 in HG, including that
NGM120 in HG may never reach clinical development; NGM Bio’s
ability to identify, attract and engage third-party partners for BD
Arrangements for its wholly-owned programs; 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 global geopolitical conflict, global economic slowdown,
increased inflation, rising interest rates and recent and potential
future bank failures); the timing of the Offer and the subsequent
Merger; uncertainties as to how many of the unaffiliated
stockholders will tender their shares in the Offer; the risk that
competing offers or acquisition proposals will be made; the
possibility that various conditions to the consummation of the
Offer and the subsequent Merger may not be satisfied or waived; the
occurrence of any event, change or other circumstance that could
give rise to the termination of the Merger Agreement, including in
circumstances which would require NGM Bio to pay a termination fee;
the effects of disruption from the transactions contemplated by the
Merger Agreement; the risk that stockholder litigation in
connection with the Offer or the Merger may result in significant
costs of defense, indemnification and liability; 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, 2023 filed with the SEC on November 2, 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 |
|
|
1 Fejzo, M., Rocha, N., Cimino, I. et al. GDF15 linked to
maternal risk of nausea and vomiting during pregnancy. Nature
(2023). https://doi.org/10.1038/s41586-023-06921-9
NGM BIOPHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS(In thousands, except
per share amounts)(Unaudited) |
|
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022* |
|
Related party revenue |
$ |
165 |
|
|
$ |
18,181 |
|
|
$ |
4,417 |
|
|
$ |
55,333 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
21,890 |
|
|
|
46,722 |
|
|
|
118,040 |
|
|
|
181,067 |
|
General and administrative |
|
7,938 |
|
|
|
9,756 |
|
|
|
37,840 |
|
|
|
40,515 |
|
Total operating expenses |
|
29,828 |
|
|
|
56,478 |
|
|
|
155,880 |
|
|
|
221,582 |
|
Loss from operations |
|
(29,663 |
) |
|
|
(38,297 |
) |
|
|
(151,463 |
) |
|
|
(166,249 |
) |
Interest income, net |
|
2,041 |
|
|
|
2,030 |
|
|
|
9,322 |
|
|
|
3,714 |
|
Other expense, net |
|
(48 |
) |
|
|
(170 |
) |
|
|
(234 |
) |
|
|
(132 |
) |
Net loss |
$ |
(27,670 |
) |
|
$ |
(36,437 |
) |
|
$ |
(142,375 |
) |
|
$ |
(162,667 |
) |
Net loss per share, basic and
diluted |
$ |
(0.33 |
) |
|
$ |
(0.45 |
) |
|
$ |
(1.73 |
) |
|
$ |
(2.03 |
) |
Weighted average shares used
to compute net loss per share, basic and diluted |
|
82,803 |
|
|
|
81,787 |
|
|
|
82,496 |
|
|
|
79,950 |
|
___________ *
Derived from the audited consolidated financial statements.
NGM BIOPHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(In thousands)(Unaudited) |
|
|
December 31,2023 |
|
December 31,2022* |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
55,816 |
|
|
$ |
73,456 |
|
Short-term marketable securities |
|
88,369 |
|
|
|
198,036 |
|
Related party receivable from collaboration |
|
58 |
|
|
|
7,580 |
|
Prepaid expenses and other current assets |
|
9,202 |
|
|
|
9,787 |
|
Restricted cash |
|
2,999 |
|
|
|
— |
|
Total current assets |
|
156,444 |
|
|
|
288,859 |
|
Property and equipment, net |
|
7,033 |
|
|
|
8,496 |
|
Operating lease right-of-use
asset |
|
— |
|
|
|
2,096 |
|
Restricted cash |
|
2,455 |
|
|
|
3,954 |
|
Other non-current assets |
|
2,936 |
|
|
|
3,997 |
|
Total assets |
$ |
168,868 |
|
|
$ |
307,402 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,982 |
|
|
$ |
8,453 |
|
Accrued liabilities |
|
17,099 |
|
|
|
33,638 |
|
Operating lease liability, current |
|
— |
|
|
|
5,385 |
|
Contract liabilities |
|
— |
|
|
|
366 |
|
Total current liabilities |
|
20,081 |
|
|
|
47,842 |
|
Other non-current
liabilities |
|
149 |
|
|
|
— |
|
Total liabilities |
|
20,230 |
|
|
|
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 |
|
872,545 |
|
|
|
841,413 |
|
Accumulated other comprehensive income (loss) |
|
18 |
|
|
|
(302 |
) |
Accumulated deficit |
|
(724,008 |
) |
|
|
(581,633 |
) |
Total stockholders' equity |
|
148,638 |
|
|
|
259,560 |
|
Total liabilities and
stockholders' equity |
$ |
168,868 |
|
|
$ |
307,402 |
|
___________ *
Derived from the audited consolidated financial statements.
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