NGM Bio Provides Business Highlights and Reports Second Quarter 2020 Financial Results
August 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 period ending June 30, 2020.
“We continue to progress across our clinical-stage programs
spanning liver, retinal and metabolic diseases as well as cancer,
despite the ongoing challenges presented by the COVID-19 pandemic,
thanks to the dedication and tireless efforts of our team, and the
ongoing support and commitment from our clinical collaborators,”
said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM.
“We’re thrilled to have achieved our most recent clinical
milestone, the advancement of NGM621 into Phase 2 development for
the treatment of patients with GA. GA is a highly prevalent and
progressive retinal degenerative disease that can have a
devastating, irreversible impact on patients’ vision and quality of
life. Based on NGM621’s novel profile as a complement C3 inhibitory
monoclonal antibody, we believe it has the potential to be an
important treatment option for this significantly underserved
patient population. It is gratifying to now have two programs in
Phase 2 clinical development in two distinct therapeutic areas,
both for the treatment of serious unmet needs.”
Dr. Woodhouse further commented, “Within the diverse NASH
development landscape, we are pleased with the impressive and
highly consistent clinical performance of aldafermin to date, with
robust, placebo-controlled data demonstrating statistically
significant dual activity in reversing fibrosis and resolving NASH.
Our Phase 2b ALPINE 2/3 and ALPINE 4 clinical studies remain on
track, and we are hard at work on Phase 3 readiness in anticipation
of an ALPINE 2/3 topline data readout in the first half of next
year.”
Key Second Quarter and Recent Highlights
Liver and metabolic disease
- Continued enrollment in Phase 2b ALPINE 2/3 study of
aldafermin in NASH. NGM has continued 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 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. Enrollment
activities have increased since our first quarter update, and we
reiterate our expectation of announcing topline data from the study
in the first half of 2021.
- Continued enrollment in Phase 2b ALPINE 4 study of
aldafermin in NASH patients with compensated cirrhosis.
NGM has 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 double‑blind, randomized,
placebo-controlled Phase 2 study (Cohort 4) of aldafermin in NASH
patients published in Gastroenterology. Comprehensive
findings and analysis from the 24-week Cohort 4 reported by NGM in
February 2020 were published this month in the journal
Gastroenterology. The 24-week double-blind, randomized,
placebo-controlled Phase 2 clinical study demonstrated
statistically significant dual activity in 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.
- Continued enrollment in Phase 1 study of NGM395 in
overweight and obese healthy adults. NGM has continued to
enroll patients in 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.
- Completed Phase 1 study of NGM217 in adults with
autoimmune diabetes. We recently completed a Phase 1 study
of NGM217, an antibody binding an undisclosed target, which
assessed the safety, tolerability and pharmacokinetics of NGM217 in
adults with autoimmune diabetes. The study demonstrated that NGM217
was well tolerated. However, as NGM continues to advance multiple
clinical‑stage programs and anticipates advancing earlier-stage
discovery programs into clinical development, the company has
decided to suspend activities related to NGM217 to concentrate its
resources on the development of other product candidates.
Retinal disease
- Initiated Phase 2 CATALINA study of NGM621 in patients
with GA. As announced in July 2020, NGM initiated the
Phase 2 CATALINA study, a multicenter, randomized, double-masked,
sham-controlled clinical trial to evaluate the safety and efficacy
of intravitreal injections (IVT) of NGM621 in patients with GA
secondary to age-related macular degeneration (AMD). Dysregulated
activation of the complement system, a key component of the immune
system, has been implicated in the onset and progression of GA.
NGM621 is a humanized IgG1 monoclonal antibody engineered to
potently inhibit activity of complement C3 with the treatment goal
of reducing disease progression in patients with GA, and with the
potential for extended every eight week dosing without PEGylation.
Designed as a Phase 3-enabling study, the Phase 2 CATALINA study is
expected to enroll 240 patients diagnosed with GA in one or both
eyes.NGM also successfully completed a first-in-human open-label
Phase 1 study in which treatment with single- and multiple-dose IVT
injections of NGM621 in patients with GA was well tolerated,
supporting advancement to the Phase 2 CATALINA study. NGM plans to
present the data from the Phase 1 study at the American Academy of
Ophthalmology (AAO) 2020 Virtual Annual Meeting from November
13-15, 2020. In addition, NGM presented NGM621 preclinical findings
at The Association for Research in Vision and Ophthalmology Annual
Meeting, held virtually in June 2020. The presentations are
available on NGM’s website.
Cancer
- Continued 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.
Corporate
- Expanded leadership with key management team and board
appointments. NGM announced the appointment of a new
executive team member, Siobhan Nolan Mangini, as Chief Financial
Officer effective July 13, 2020 and announced the appointment of
Carole Ho, M.D. to its Board of Directors. Dr. Ho currently
serves as Chief Medical Officer and Head of Development at Denali
Therapeutics.
Merck Collaboration
Merck has a one-time option to license NGM pipeline programs,
other than NGM’s wholly-owned programs 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, 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. In January 2019,
Merck exercised its first option under the collaboration to license
NGM313, also referred to as MK‑3655.
Second Quarter Financial Results
- For the quarter ended June 30, 2020, NGM reported a net loss of
$25.6 million compared to a net loss of $7.7 million for the
corresponding period in 2019.
- Related party revenue from our collaboration with Merck for the
quarter ended June 30, 2020 was $19.8 million compared to
$25.3 million for the corresponding period in 2019. The decrease in
related party revenue was primarily attributable to the completion
of all remaining obligations associated with the upfront payment at
the conclusion of the initial five-year term of the Merck
collaboration.
- Research and development expenses for the quarter ended June
30, 2020 were $38.5 million compared to $28.8 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 expenses related
to our aldafermin, NGM621 and NGM395 programs, and
personnel-related expenses driven by increased headcount.
- General and administrative expenses for the quarter ended June
30, 2020 were $6.8 million compared to $6.2 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 and legal
expenses to support our operations as a public company.
- Cash, cash equivalents and short-term marketable securities
were $312.1 million as of June 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, retinal and metabolic
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 “progress,” “advance,” “believe,”
“potential,” “continue,” “expect,” “anticipates,” “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 ongoing 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 topline results of the ALPINE 2/3 study and the presentation of
data from the Phase 1 study of NGM621 in patients with GA; the
potential of NGM621 to be an important treatment option for
patients with GA; NGM’s ability to advance aldafermin toward Phase
3 clinical development for NASH patients; the safety, tolerability
and efficacy of NGM’s product candidates; and continued development
of additional product candidates, including NGM621, NGM395 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 “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” in our quarterly report on
Form 10-Q for the quarter ended March 31, 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 |
|
|
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except share and per share
amounts)(Unaudited)
|
Three Months
Ended |
|
|
Six Months
Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Related party revenue |
$ |
19,755 |
|
|
$ |
25,341 |
|
|
$ |
44,119 |
|
|
$ |
50,893 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
38,494 |
|
|
|
28,819 |
|
|
|
76,933 |
|
|
|
58,346 |
|
General and administrative |
|
6,794 |
|
|
|
6,229 |
|
|
|
13,389 |
|
|
|
11,596 |
|
Total operating expenses |
|
45,288 |
|
|
|
35,048 |
|
|
|
90,322 |
|
|
|
69,942 |
|
Loss from
operations |
|
(25,533 |
) |
|
|
(9,707 |
) |
|
|
(46,203 |
) |
|
|
(19,049 |
) |
Interest
income |
|
388 |
|
|
|
2,044 |
|
|
|
1,563 |
|
|
|
3,154 |
|
Other
expense, net |
|
(471 |
) |
|
|
(6 |
) |
|
|
(91 |
) |
|
|
(42 |
) |
Net
loss |
$ |
(25,616 |
) |
|
$ |
(7,669 |
) |
|
$ |
(44,731 |
) |
|
$ |
(15,937 |
) |
Net loss per
share, basic and diluted |
$ |
(0.38 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.66 |
) |
|
$ |
(0.47 |
) |
Weighted
average shares used to compute |
|
68,305,056 |
|
|
|
61,044,450 |
|
|
|
67,850,640 |
|
|
|
34,078,099 |
(1) |
net
loss per share, basic and diluted |
(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. |
NGM BIOPHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands)(Unaudited)
|
June 30, |
|
|
December 31, |
|
|
2020 |
|
|
2019* |
|
Assets |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
249,317 |
|
|
$ |
245,598 |
|
Short-term marketable securities |
|
62,778 |
|
|
|
98,913 |
|
Related party receivable from collaboration |
|
3,079 |
|
|
|
5,206 |
|
Prepaid expenses and other current assets |
|
7,448 |
|
|
|
5,531 |
|
Total current assets |
|
322,622 |
|
|
|
355,248 |
|
Property and
equipment, net |
|
17,321 |
|
|
|
19,475 |
|
Restricted
cash |
|
1,874 |
|
|
|
1,874 |
|
Other
non-current assets |
|
5,467 |
|
|
|
3,806 |
|
Total assets |
$ |
347,284 |
|
|
$ |
380,403 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,934 |
|
|
$ |
9,026 |
|
Accrued liabilities |
|
26,792 |
|
|
|
22,991 |
|
Deferred rent, current |
|
2,902 |
|
|
|
2,829 |
|
Deferred revenue, current |
|
2,074 |
|
|
|
4,872 |
|
Total current liabilities |
|
33,702 |
|
|
|
39,718 |
|
Deferred
rent, non-current |
|
7,941 |
|
|
|
9,392 |
|
Other
non-current liabilities |
|
4,188 |
|
|
|
— |
|
Early
exercise stock option liability |
|
289 |
|
|
|
574 |
|
Total liabilities |
|
46,120 |
|
|
|
49,684 |
|
Commitments
and contingencies |
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; |
|
69 |
|
|
|
67 |
|
Additional paid-in capital |
|
541,833 |
|
|
|
526,771 |
|
Accumulated other comprehensive gain |
|
137 |
|
|
|
25 |
|
Accumulated deficit |
|
(240,875 |
) |
|
|
(196,144 |
) |
Total stockholders' equity |
|
301,164 |
|
|
|
330,719 |
|
Total liabilities and stockholders' equity |
$ |
347,284 |
|
|
$ |
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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