NGM Bio Outlines 2021 Strategic Priorities Across Its Three Therapeutic Area Portfolios, Including Liver and Metabolic Diseas...
January 12 2021 - 4:05PM
NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology
company focused on discovering and developing transformative
therapeutics for patients, today outlined its key achievements in
2020 and its strategic priorities for 2021.
“2020 was a year of significant progress and growth for NGM
across our pipeline, now comprising three therapeutic area
portfolios – liver and metabolic diseases, retinal diseases and
oncology. We have clinical programs underway across all of these
therapeutic areas, including three programs in Phase 2b or Phase
3-enabling studies. We are also pleased to
be heading into 2021 with approximately $425 million in
cash, cash equivalents and short-term marketable securities,
inclusive of the proceeds of our recent equity offering, to
fuel our growing pipeline,” said David J. Woodhouse, Ph.D., Chief
Executive Officer at NGM.
Dr. Woodhouse further commented, “Our vision is to build the
next iconic biologics company, ultimately self-sustaining with
multiple products on the market and a diverse pipeline of
development candidates, all fueled by our in-house discovery engine
and talented team. In 2021 we expect to make meaningful progress
toward realizing that vision. We anticipate reporting topline data
from our Phase 2b ALPINE 2/3 study of aldafermin in NASH patients
in the second quarter and continue to aggressively plan for Phase 3
development. We also anticipate moving our two recently announced
oncology clinical candidates, NGM707 and NGM438, into the clinic
this year. Our inspiration to make progress and advance our
pipeline are the many patients waiting for effective
treatments.”
2020 Highlights
NGM’s key achievements and milestones across its pipeline in
2020 included:
Liver and metabolic diseases
- Reported positive liver histology and biomarker data from a
Phase 2 24-week study (Cohort 4) of aldafermin in patients with
non-alcoholic steatohepatitis (NASH) in February 2020.
- Initiated a Phase 2b study of aldafermin in patients with NASH
with F4 liver fibrosis (ALPINE 4) in February 2020.
- Completed enrollment in the Phase 2b study of aldafermin in
patients with NASH with stage 2 (F2) or F3 liver fibrosis (ALPINE
2/3) in September 2020.
- Our partner, Merck, initiated a global Phase 2b study of
MK-3655 in patients with NASH with F2/F3 fibrosis in the fourth
quarter of 2020.
Retinal diseases
- Initiated the Phase 2 CATALINA study of NGM621 for the
treatment of geographic atrophy (GA) in July 2020.
- Presented Phase 1 safety and pharmacokinetics data for NGM621
in patients with GA at the American Academy of Ophthalmology in
November 2020.
Cancer
- Completed enrollment in dose-finding Phase 1a/1b studies of
NGM120 for the treatment of cancer anorexia/cachexia syndrome
(CACS) and cancer in November 2020.
- In the fourth quarter of 2020, announced two new oncology
clinical candidates, NGM707 and NGM438, which are designed to
broaden and deepen anti-tumor immune responses for patients with
advanced solid tumors by reversing key myeloid and stromal
resistance mechanisms.
2021 Strategic Priorities and Anticipated
Milestones
NGM has several strategic priorities for 2021 intended to
further the company’s discovery engine and growing portfolio of
programs. NGM’s strategic priorities and anticipated key milestones
in 2021 include:
Liver and metabolic diseases
- Report topline data from Phase 2b ALPINE 2/3 study of
aldafermin in patients with NASH with F2/F3 liver fibrosis in the
second quarter of 2021.
- Continue advancement of Phase 2b ALPINE 4 study of aldafermin
in patients with NASH with F4 liver fibrosis.
- Continue planning for aldafermin Phase 3 development
program.
Retinal diseases
- Continue advancement of the Phase 2 CATALINA study of NGM621 in
patients with GA.
Oncology
- Report data from ongoing dose-finding Phase 1a/1b study of
NGM120 in CACS and cancer patients in the second half of 2021.
- Initiate Phase 1b, placebo-controlled, expansion study of
NGM120 in patients with metastatic pancreatic cancer, assessing
both cancer and CACS endpoints, in the first quarter of 2021.
- Initiate Phase 1 studies of NGM707 and NGM438 in mid-2021 and
the fourth quarter of 2021, respectively.
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 oncology. 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.
About the NGM-Merck Collaboration
Merck has a one-time option to license certain NGM pipeline
programs – not including aldafermin, NGM395 and NGM386 – 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 November 2018, Merck exercised its first
option under the collaboration to license MK-3655, previously
referred to as NGM313.
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 “build,” “plans,” expects,” “anticipates,”
“designed to,” “continue,” “potential” 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 productivity of NGM’s research and advancement of NGM’s
clinical and preclinical pipeline, including its vision to build
the next iconic biologics company with multiple approved products;
the continued progress of, and the timing of enrollment and results
of, NGM’s clinical trials, including timing of the initiation of
Phase 1 studies for NGM707 and NGM438, topline data readout for the
Phase 2b ALPINE 2/3 study, topline data readout for the Phase 1a/1b
study of NGM120; and the design, timing, enrollment, safety,
tolerability and efficacy of, and continued development of, NGM’s
product candidates, including aldafermin (NGM282), MK-3655
(NGM313), NGM621, NGM120, NGM707, NGM438 and any of our future
product candidates. 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 September 30, 2020, the section
titled “Risk Factors” in exhibit 99.1 to our current report on Form
8-K filed with the United States Securities and Exchange Commission
(SEC) on January 6, 2021 and future filings and reports that NGM
makes from time to time with the SEC. 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 |
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Media Contact:Liz Melonemedia@ngmbio.com |
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