NGM Bio Provides Business Update and Reports First Quarter 2020 Financial Results
May 13 2020 - 4:05PM
NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology
company focused on developing transformative therapeutics for
patients, today provided a business update and reported financial
results for the period ending March 31, 2020.
“In the first quarter of 2020, we demonstrated strong execution
across our broad pipeline in multiple therapeutic areas. As we
continue to navigate the ever-evolving COVID-19 situation, we have
been fortunate to continue to move forward with our programs, most
notably with the initiation of our Phase 2b ALPINE 4 study of
aldafermin in patients with compensated cirrhosis due to NASH, a
very sick patient population for which there is no currently
available treatment other than liver transplant,” said David J.
Woodhouse, Ph.D., Chief Executive Officer at NGM. “As previously
announced, in the first quarter of 2020, we also initiated a Phase
1a/1b clinical study for NGM120 as a potential treatment for cancer
and cancer anorexia/cachexia syndrome, or CACS, and a Phase 1
clinical study for NGM395 as a potential treatment for metabolic
disease, bringing us to a total of six product candidates now in
clinical development. As we advance our clinical programs during
these uncertain and unsettling times, the safety and well-being of
patients, healthcare workers and our employees remain our top
priority. We are closely monitoring the impact of COVID-19 on our
organization and business operations and, like others in our
industry, are managing multiple challenges to mitigate disruptions
in our ongoing and planned trials in order to remain on track with
our development timelines. The high unmet medical needs targeted by
each of our development programs provide strong motivation for us
to remain focused on execution across our pipeline.”
Throughout the unfolding COVID-19 situation, NGM has worked
proactively to establish policies that are designed to enable the
company to operate safely, efficiently and productively, preserving
mission-critical functions necessary to advance key research and
development activities while safeguarding the well-being of
patients, study investigators, clinical research staff and NGM
employees. For patients already enrolled in NGM clinical trials,
the company is working closely with investigators and site staff to
continue treatment in compliance with study protocols and to uphold
trial integrity, while observing government and institutional
guidelines. NGM is continuing to evaluate site initiations and
patient enrollment on a case-by-case and patient-by-patient basis
in close coordination with investigators and site staff. Some
sites, both within and outside of the United States, continue to
screen patients for studies, and new patients are being enrolled
when appropriate. These internal and external efforts have allowed
NGM to continue progress across its clinical development programs.
While NGM has experienced a slower pace of site initiation and
trial enrollment than originally anticipated in certain of its
clinical studies, the impact of the COVID-19 pandemic, to date, has
not resulted in a significant impact to the company’s development
timelines.
“At this time, we remain on track with all previously provided
clinical trial timing guidance and will continue to monitor
screening, enrollment and site initiations across our pipeline to
understand any potential future impact on timing,” said Dr.
Woodhouse. “I admire and am extremely grateful for the dedication
and agility of our team, the ongoing commitment of study
investigators and clinical study site staff, and the broader
ecosystem that is enabling important research and development work
to continue at NGM and across our industry.”
Key First Quarter and Recent Highlights
Cardio-metabolic and liver disease
- Initiated Phase 2b ALPINE 4 study of aldafermin in
compensated NASH cirrhosis (F4). In March 2020, NGM dosed
the first patient in the dose-ranging ALPINE 4 study
to evaluate the safety and efficacy of aldafermin versus placebo in
patients with biopsy-confirmed NASH cirrhosis. The primary efficacy
objective is to evaluate the treatment effect on histology, defined
as fibrosis regression of at least one stage without worsening of
NASH. This global, multi-center study is expected to enroll
approximately 150 patients who will be dosed with 0.3 mg, 1 mg, 3
mg of aldafermin or placebo for 48 weeks. Aldafermin is
wholly-owned by NGM.“We are pleased to have initiated our Phase 2b
ALPINE 4 clinical study and thrilled we have achieved this
significant milestone, marking our first study in F4 NASH patients
with well-compensated cirrhosis,” said Hsiao D. Lieu, M.D., Chief
Medical Officer at NGM. “We anticipate that the COVID-19 pandemic
will impact activation of additional trial sites, and we plan to
work closely with our target sites to navigate their processes and
needs in an effort to mitigate delays. Reversing fibrosis and
bringing advanced stage NASH patients back from the brink of liver
transplant could have a profound, potentially life-saving impact.
Based on the rapid, robust anti-fibrotic treatment effect we have
seen with aldafermin to date in F2 and F3 NASH patients, we are
encouraged by the potential to see activity in a patient population
facing a particularly critical need for effective therapeutic
solutions.”
- Continued enrollment in Phase 2b study of aldafermin in
NASH patients with Stage 2 or 3 (F2-F3) fibrosis. NGM has
continued to enroll patients in the Phase 2b ALPINE 2/3 clinical
study in patients with biopsy-confirmed NASH and F2-F3 liver
fibrosis. The 24-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.
Despite a lower-than-anticipated pace of enrollment as a result of
COVID-19, NGM expects to announce topline data from the study in
the first half of 2021, as previously guided. However, the extended
impact of COVID-19 on our timeline is difficult to
predict.
- Announced positive preliminary topline liver histology
and biomarker data from 24-week Phase 2 study of aldafermin 1 mg in
patients with NASH (Cohort 4). In February 2020, NGM
announced positive preliminary topline results from a 24-week
double-blind, randomized, placebo-controlled Phase 2 clinical study
(Cohort 4) of aldafermin in NASH patients with F2-F3 fibrosis.
Cohort 4 was the final reported cohort from NGM’s adaptive Phase 2
clinical study of aldafermin in NASH. Cohort 4 was powered to
demonstrate the effect of 1 mg aldafermin treatment versus placebo
on the primary endpoint of change in absolute liver fat content,
which achieved statistical significance. In addition, the study
assessed secondary and exploratory endpoints of liver histology and
biomarkers of disease activity. The histology results revealed that
treatment with aldafermin led to clinically meaningful improvements
at 24 weeks versus placebo in fibrosis improvement of ≥1 stage with
no worsening of NASH (38% of aldafermin-treated patients vs. 18%
placebo) and in resolution of NASH with no worsening of liver
fibrosis (24% of aldafermin-treated patients vs. 9% placebo). The
study also demonstrated a statistically significant impact on the
composite endpoint of both fibrosis improvement and resolution of
NASH (22% in aldafermin-treated patients vs. 0% placebo). In the
study, aldafermin continued to demonstrate a favorable tolerability
profile.
- Initiated Phase 1 study of NGM395 in overweight and
obese healthy adults. As announced in March 2020, NGM
initiated a Phase 1 single ascending dose clinical study evaluating
the safety, tolerability and pharmacokinetics of NGM395, a
long-acting growth differentiation factor 15 (GDF15) analog, in
overweight and obese but otherwise healthy adults. NGM395 is
wholly-owned by NGM.
Ophthalmic disease
- Completed enrollment in Phase 1 study of NGM621 for the
potential treatment of geographic atrophy (GA), an advanced dry
form of age-related macular degeneration (AMD). The Phase
1 clinical study is designed to evaluate the safety, tolerability
and pharmacokinetics of up to two intravitreal doses of NGM621 in
patients with GA. NGM621 is an inhibitory antibody binding
complement C3, a key node of all three complement pathways. NGM
plans to present the Phase 1 results at a future scientific
congress and to initiate a Phase 2 study in the second half of this
year.
Cancer
- Initiated Phase 1a/1b study of NGM120 for the potential
treatment of CACS and cancer. As announced in February
2020, NGM initiated 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, or 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 options, 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, in certain cases, 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.
First Quarter Financial Results
- For the quarter ended March 31, 2020, NGM reported a net loss
of $19.1 million compared to a net loss of $8.3 million for the
corresponding period in 2019.
- Related party revenue from our collaboration with Merck for the
quarter ended March 31, 2020 was $24.4 million compared to
$25.6 million for the corresponding period in 2019.
- Research and development expenses for the quarter ended March
31, 2020 were $38.4 million compared to $29.5 million for the
corresponding period in 2019. The increase in research and
development expenses was primarily attributable to increases in
external research and development expenses associated with the
advancement of NGM’s growing pipeline, including aldafermin program
expenses for Phase 2b clinical trials, and personnel-related
expenses driven by increased headcount.
- General and administrative expenses for the quarter ended March
31, 2020 were $6.6 million compared to $5.4 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, insurance
expenses, consulting expenses and other professional service
expenses required to support NGM’s operations as a public
company.
- Cash, cash equivalents and short-term marketable securities
were $328.5 million as of March 31, 2020, compared to
$344.5 million as of December 31, 2019.
About NGM Biopharmaceuticals, Inc.
NGM is a biopharmaceutical company focused on developing novel
therapeutics based on scientific understanding of key biological
pathways underlying cardio-metabolic, liver, oncologic and
ophthalmic diseases. 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 “continue,” “move forward,” “advance,”
“anticipates,” “expect,” “plans” 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
advancement of NGM’s clinical and preclinical pipeline; the impact
of the COVID-19 pandemic on clinical trial plans and timelines,
including enrollment, activation and initiation of additional trial
sites and results of NGM’s clinical trials; the continued progress
of, and the timing of enrollment and results of, NGM’s clinical
trials, including timing of preliminary results of the ALPINE 2/3
study, the presentation of results of the Phase 1 study of NGM621
for the potential treatment of geographic atrophy and the
initiation of the related Phase 2 study; the safety, tolerability
and efficacy of NGM’s product candidates; and continued development
of additional product candidates, including NGM621 in patients with
GA, NGM120 in patients with CACS and cancer and NGM395. 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 those
discussed in the sections titled “Risk Factors” and “Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” in our annual report on Form 10-K for the year ended
December 31, 2019 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:Sylvia Wheeler and Alexandra
Santosswheeler@wheelhouselsa.comasantos@wheelhouselsa.comir@ngmbio.com |
Media Contact:Liz Melonemedia@ngmbio.com |
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except share and per share
amounts)(Unaudited)
|
|
Three Months Ended
March 31, |
|
|
|
2020 |
|
|
2019(1) |
|
Related party revenue |
|
$ |
24,364 |
|
|
$ |
25,552 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
38,439 |
|
|
|
29,527 |
|
General and administrative |
|
|
6,595 |
|
|
|
5,367 |
|
Total operating expenses |
|
|
45,034 |
|
|
|
34,894 |
|
Loss from operations |
|
|
(20,670 |
) |
|
|
(9,342 |
) |
Interest income |
|
|
1,175 |
|
|
|
1,110 |
|
Other income (expense), net |
|
|
380 |
|
|
|
(36 |
) |
Net loss |
|
$ |
(19,115 |
) |
|
$ |
(8,268 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.28 |
) |
|
$ |
(1.21 |
) |
Weighted average shares used to
compute net loss per share, basic and diluted |
|
|
67,396,229 |
|
|
|
6,812,129 |
|
(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. All of the then outstanding shares of
convertible preferred stock were automatically converted into
shares of common stock upon the closing of the IPO. |
|
|
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands)(Unaudited)
|
|
March 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019* |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
256,952 |
|
|
$ |
245,598 |
|
Short-term marketable securities |
|
|
71,517 |
|
|
|
98,913 |
|
Related party receivable from collaboration |
|
|
742 |
|
|
|
5,206 |
|
Prepaid expenses and other current assets |
|
|
9,096 |
|
|
|
5,531 |
|
Total current assets |
|
|
338,307 |
|
|
|
355,248 |
|
Property and equipment, net |
|
|
18,274 |
|
|
|
19,475 |
|
Restricted cash |
|
|
1,874 |
|
|
|
1,874 |
|
Other non-current assets |
|
|
2,246 |
|
|
|
3,806 |
|
Total assets |
|
$ |
360,701 |
|
|
$ |
380,403 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,648 |
|
|
$ |
9,026 |
|
Accrued liabilities |
|
|
21,949 |
|
|
|
22,991 |
|
Deferred rent, current |
|
|
2,865 |
|
|
|
2,829 |
|
Deferred revenue, current |
|
|
— |
|
|
|
4,872 |
|
Total current liabilities |
|
|
28,462 |
|
|
|
39,718 |
|
Deferred rent, non-current |
|
|
8,667 |
|
|
|
9,392 |
|
Other non-current
liabilities |
|
|
4,188 |
|
|
|
— |
|
Early exercise stock option
liability |
|
|
412 |
|
|
|
574 |
|
Total liabilities |
|
|
41,729 |
|
|
|
49,684 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par
value; |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par
value; |
|
|
68 |
|
|
|
67 |
|
Additional paid-in capital |
|
|
534,218 |
|
|
|
526,771 |
|
Accumulated other comprehensive gain (loss) |
|
|
(55 |
) |
|
|
25 |
|
Accumulated deficit |
|
|
(215,259 |
) |
|
|
(196,144 |
) |
Total stockholders' equity |
|
|
318,972 |
|
|
|
330,719 |
|
Total liabilities and stockholders' equity |
|
$ |
360,701 |
|
|
$ |
380,403 |
|
*The Condensed Consolidated Balance Sheet as of December
31, 2019 has been derived from the audited financial statements as
of that date.
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