NGM Bio Provides Business Highlights and Reports Third Quarter 2020 Financial Results
November 12 2020 - 4:05PM
NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology
company focused on discovering and developing transformative
therapeutics for patients, today provided business highlights and
reported financial results for the quarter ended September 30,
2020.
“We made notable progress across our pipeline this past quarter,
as we continue to pursue a portfolio of product candidates directed
to biologically powerful targets,” said David J. Woodhouse, Ph.D.,
Chief Executive Officer at NGM. “Since mid-July, we have initiated
a Phase 2 clinical trial of NGM621, our anti-complement C3
antibody, designed to slow disease progression in people with
geographic atrophy, and we have disclosed our first immuno-oncology
development candidate, NGM707, a novel dual antagonist antibody
inhibiting ILT2 and ILT4, designed to potentially improve patient
immune responses to tumors.”
Dr. Woodhouse continued, “We look forward to our upcoming
R&D Day on December 9th, where we will showcase not only our
exciting portfolio of programs but also highlight the talented NGM
scientists whose expertise, creativity and passion have enabled our
track record of rapid innovation and sustained productivity.”
Key Third Quarter and
Recent Highlights
Liver and metabolic diseases
- Completed enrollment in Phase 2b ALPINE 2/3 study of
aldafermin in NASH patients. NGM completed enrollment in
the Phase 2b ALPINE 2/3 clinical study of aldafermin in patients
with biopsy-confirmed NASH and stage 2 or 3 (F2-F3) liver fibrosis.
The 24-week study will assess the efficacy, safety and tolerability
of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo.
The primary objective of the ALPINE 2/3 study is to evaluate a dose
response showing an improvement in liver fibrosis by ≥ 1 stage with
no worsening of steatohepatitis at week 24. NGM expects to report
topline findings from the study in the second quarter of 2021.
- Ongoing enrollment in Phase 2b ALPINE
4 study of aldafermin in NASH patients with compensated
cirrhosis. NGM continued enrollment in the Phase 2b
ALPINE 4 study of aldafermin in patients with
biopsy-confirmed compensated NASH cirrhosis (F4). The 48-week study
is designed to enroll approximately 150 patients and will assess
the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg
doses of aldafermin compared to placebo.
- Data from 24-week doubleblind,
randomized, placebo-controlled Phase 2 study (Cohort 4) of
aldafermin in NASH patients presented at The
Digital International Liver Congress™
2020 and published
in Gastroenterology.
Cohort 4 demonstrated statistically significant dual activity in
both reversing fibrosis and resolving NASH. In the study,
aldafermin continued to demonstrate a favorable tolerability
profile. Cohort 4 was the final reported cohort from NGM’s adaptive
Phase 2 clinical study of aldafermin in NASH, and the results
observed in Cohort 4 were consistent with data from the three
previous cohorts.
Retinal diseases
- Initiated Phase 2 CATALINA study of NGM621 in patients
with GA. In July, NGM began the Phase 2 CATALINA study, a
multicenter, randomized, double-masked, sham-controlled clinical
trial to evaluate the safety and efficacy of intravitreal (IVT)
injections of NGM621 in patients with GA secondary to age-related
macular degeneration. NGM anticipates enrolling 240 patients
diagnosed with GA in one or both eyes.
- NGM will present results from
a Phase 1 study of
NGM621 in patients with GA at the
American Academy of Ophthalmology (AAO) Virtual Annual
Meeting on November 13, 2020 at 10:00
a.m.
ET. NGM completed the Phase 1
study with single- and multiple-dose IVT injections of NGM621 in
patients with GA. The AAO presentation will be the first-in-human
data presented on NGM621 in GA.
Cancer
- Expanded oncology portfolio
with first
immuno-oncology development candidate, NGM707, a
dual antagonist antibody
inhibiting ILT2 and
ILT4. These receptors represent key
myeloid and lymphoid checkpoints, and may restrict anti-tumor
immunity, enable tumors to evade immune detection and contribute to
T cell checkpoint resistance. NGM plans to initiate first-in-human
testing of NGM707 in mid-2021 in patients with advanced solid
tumors.
- Ongoing enrollment in Phase 1a/1b
study of NGM120 in patients with cancer anorexia/cachexia
syndrome (CACS) and cancer. NGM continues
to enroll patients in a Phase 1a/1b clinical study to evaluate
NGM120, a first-in-class antagonistic antibody that binds glial
cell-derived neurotrophic factor receptor alpha-like (GFRAL) and
inhibits GDF15 signaling, for the potential treatment of CACS and
cancer. CACS is the uncontrolled wasting of both skeletal muscle
and fat that is a common co-morbidity of cancer and is associated
with shortened survival in cancer patients.
Merck Collaboration
Merck has a one-time option to license NGM pipeline programs –
other than aldafermin and NGM395 – following human proof-of-concept
trials under the terms of the companies’ ongoing strategic
collaboration. Upon exercising any such option, Merck would lead
global product development and commercialization for the resulting
products, if approved. Prior to Merck initiating a Phase 3 study
for a licensed program, NGM may elect to either receive milestone
and royalty payments or to co-fund development and participate in a
global cost and revenue share arrangement of up to 50%. The
agreement also provides NGM with the option to participate in the
co-promotion of any co-funded program in the United States.
In January 2019, Merck exercised its first option under the
collaboration to license MK-3655, previously referred to as
NGM313.
Third Quarter Financial
Results
- For the quarter ended September 30, 2020, NGM reported a net
loss of $29.8 million, compared to a net loss of $10.9 million for
the corresponding period in 2019.
- Related party revenue from our collaboration with Merck for the
quarter ended September 30, 2020 was $23.5 million, compared to
$21.6 million for the corresponding period in 2019.
- Research and development expenses for the quarter ended
September 30, 2020 were $47.0 million, compared to $29.0 million
for the corresponding period in 2019. The increase in research and
development expenses was mainly attributable to increases in
external research and development expenses associated with the
advancement of NGM’s growing pipeline, primarily related to our
aldafermin, NGM621, NGM120 and NGM707 programs, and
personnel-related expenses driven by increased headcount.
- General and administrative expenses for the quarter ended
September 30, 2020 were $6.5 million, compared to $5.6 million for
the corresponding period in 2019. The increase in general and
administrative expenses was primarily attributable to increases in
personnel-related expenses driven by increased headcount, as well
as external expenses to support our operations as a public
company.
- Cash, cash equivalents and short-term marketable securities
were $287.9 million as of September 30, 2020, compared to
$344.5 million as of December 31, 2019.
About NGM Biopharmaceuticals, Inc.
NGM is a biopharmaceutical company focused on discovering and
developing novel therapeutics based on scientific understanding of
key biological pathways underlying liver and metabolic diseases,
retinal diseases and cancer. We leverage our biology-centric drug
discovery approach to uncover novel mechanisms of action and
generate proprietary insights that enable us to move rapidly into
proof-of-concept studies and deliver potential first-in-class
medicines to patients. At NGM, we aspire to operate one of the most
productive research and development engines in the
biopharmaceutical industry, with multiple programs in clinical
development. Visit us at www.ngmbio.com for more information.
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,” “planned,” “pursue,” “look forward,”
“expects,” ‘designed to,” “anticipates,” “plans,” “potential,”
“aspire” 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 NGM’s intentions to present at
future events; the productivity of NGM’s research and advancement
of NGM’s clinical and preclinical pipeline; the continued progress
of, and the timing of enrollment and results of, NGM’s clinical
trials, including timing of topline results of the ALPINE 2/3 study
and the presentation of data from the Phase 1 study of NGM621 in
patients with GA; and the design, timing, enrollment, safety,
tolerability and efficacy of, and continued development of, NGM’s
product candidates, including aldafermin, NGM621, NGM707 and
NGM120. Because such statements deal with future events and are
based on NGM’s current expectations, they are subject to various
risks and uncertainties, and actual results, performance or
achievements of NGM 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
enrolling or completing clinical studies, the risk that the results
obtained to date in NGM’s clinical trials may not be indicative of
results obtained in subsequent pivotal or other late-stage trials,
and the risk that NGM’s ongoing or future clinical studies in
humans may show that aldafermin is not a tolerable and effective
treatment for NASH patients; the ongoing COVID-19 pandemic, which
has adversely affected, and could materially and adversely affect
in the future, our business and operations; the time-consuming and
uncertain regulatory approval process; NGM’s reliance on
third-party manufacturers for aldafermin and its other product
candidates; the sufficiency of NGM’s cash, cash equivalents and
short-term marketable securities and need for additional capital;
and other risks and uncertainties affecting NGM and its development
programs, as well as those discussed in the sections titled
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations” and “Risk Factors” in our quarterly report
on Form 10-Q for the quarter ended June 30, 2020 and future filings
and reports that NGM makes from time to time with the United States
Securities and Exchange Commission. Except as required by law, NGM
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:Alex Schwartzir@ngmbio.com |
Media Contact:Liz Melonemedia@ngmbio.com |
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NGM BIOPHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS(In thousands, except
share and per share amounts)(Unaudited) |
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2020 |
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2019 |
|
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2020 |
|
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2019 |
|
Related party
revenue |
$ |
23,482 |
|
|
$ |
21,568 |
|
|
$ |
67,601 |
|
|
$ |
72,461 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Research and development |
|
46,979 |
|
|
|
28,953 |
|
|
|
123,912 |
|
|
|
87,299 |
|
General and administrative |
|
|
6,460 |
|
|
|
5,612 |
|
|
|
19,849 |
|
|
|
17,208 |
|
Total operating expenses |
|
53,439 |
|
|
|
34,565 |
|
|
|
143,761 |
|
|
|
104,507 |
|
Loss from
operations |
|
|
(29,957 |
) |
|
|
(12,997 |
) |
|
|
(76,160 |
) |
|
|
(32,046 |
) |
Interest income |
|
|
260 |
|
|
|
1,984 |
|
|
|
1,823 |
|
|
|
5,138 |
|
Other income
(expense), net |
|
|
(68 |
) |
|
|
96 |
|
|
|
(159 |
) |
|
|
54 |
|
Net loss |
|
$ |
(29,765 |
) |
|
$ |
(10,917 |
) |
|
$ |
(74,496 |
) |
|
$ |
(26,854 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.17 |
) |
|
$ |
(1.09 |
) |
|
$ |
(0.60 |
) |
Weighted average
shares used to compute net loss per share, basic and diluted |
|
|
68,815,696 |
|
|
|
65,948,207 |
|
|
|
68,174,654 |
|
|
|
44,828,596 |
|
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(1) |
|
In April 2019, the
Company completed its initial public offering (IPO) and concurrent
private placement with Merck Sharp & Dohme Corp., in which the
Company issued an aggregate of 7,521,394 and 4,121,683 shares of
common stock, respectively, and all of the then outstanding shares
of convertible preferred stock were automatically converted into
shares of common stock upon the closing of the IPO. |
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NGM BIOPHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(In thousands)(Unaudited) |
|
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September 30, |
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December 31, |
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2020 |
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2019 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
|
$ |
253,976 |
|
|
$ |
245,598 |
|
Short-term marketable securities |
|
|
33,973 |
|
|
|
98,913 |
|
Related party receivable from collaboration |
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|
7,215 |
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|
5,206 |
|
Prepaid expenses and other current assets |
|
|
7,076 |
|
|
|
5,531 |
|
Total current assets |
|
|
302,240 |
|
|
|
355,248 |
|
Property and equipment, net |
|
|
15,773 |
|
|
|
19,475 |
|
Restricted cash |
|
|
1,499 |
|
|
|
1,874 |
|
Other non-current assets |
|
|
6,570 |
|
|
|
3,806 |
|
Total assets |
|
$ |
326,082 |
|
|
$ |
380,403 |
|
Liabilities
and stockholders' equity |
|
|
|
|
|
|
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Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,613 |
|
|
$ |
9,026 |
|
Accrued liabilities |
|
|
28,579 |
|
|
|
22,991 |
|
Deferred rent, current |
|
|
2,938 |
|
|
|
2,829 |
|
Deferred revenue, current |
|
|
4,586 |
|
|
|
4,872 |
|
Total current liabilities |
|
|
37,716 |
|
|
|
39,718 |
|
Deferred rent, non-current |
|
|
7,179 |
|
|
|
9,392 |
|
Other non-current
liabilities |
|
|
4,315 |
|
|
|
— |
|
Early exercise stock option
liability |
|
|
169 |
|
|
|
574 |
|
Total liabilities |
|
|
49,379 |
|
|
|
49,684 |
|
Commitments and
contingencies |
|
|
|
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Stockholders' equity: |
|
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|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized;no
shares issued or outstanding as of September 30, 2020 andDecember
31, 2019, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 400,000,000 shares
authorized;68,934,767 and 66,960,279 shares issued and outstanding
as ofSeptember 30, 2020 and December 31, 2019, respectively |
|
|
69 |
|
|
|
67 |
|
Additional paid-in capital |
|
|
547,259 |
|
|
|
526,771 |
|
Accumulated other comprehensive gain |
|
|
15 |
|
|
|
25 |
|
Accumulated deficit |
|
|
(270,640 |
) |
|
|
(196,144 |
) |
Total stockholders' equity |
|
|
276,703 |
|
|
|
330,719 |
|
Total liabilities and stockholders' equity |
|
$ |
326,082 |
|
|
$ |
380,403 |
|
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