Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or
the “Company”), a clinical-stage drug development company
pioneering transformative medicines that target the endocannabinoid
system (“ECS”), today reported financial results for the third
quarter of 2020. The Company also provided clinical, pipeline and
corporate updates.
Yuval Cohen, Ph.D., Chief Executive Officer
said, “We are emerging from a very challenging period with a
continued focus on our lenabasum dermatomyositis program and
preclinical pipeline. Our restructuring significantly improved our
cash runway, so we can continue to work toward delivering a
much-needed novel therapeutic option for patients while also giving
us the resources to look at external assets that will be
synergistic to our in-house capabilities. We expect our cash runway
to be further extended with the cost savings from our plan to
shorten the DETERMINE Phase 3
dermatomyositis study to 28 weeks from one year. This decision is
driven by recent changes in the dermatomyositis competitive
landscape and will accelerate topline data readout to the second
quarter of 2021. We see our dermatomyositis program as a potential
large value driver for our Company, given that there are about
40,000 dermatomyositis patients in North America and limitations
with current treatment options.”
Dr. Cohen continued, “While we were disappointed
that both the RESOLVE-1 systemic sclerosis study and the Phase 2b
cystic fibrosis study did not meet their primary endpoints, we have
a solid understanding of what led to those outcomes. The data
generated point to clinical activity associated with lenabasum
treatment. The dataset also provided unique insight into disease
progression and the impact of current standards of care. With this
in mind, we are working with systemic sclerosis and cystic fibrosis
experts to further analyze the data and potentially explore paths
forward in these programs.”
Clinical Program Updates:
Lenabasum: a novel, oral, selective cannabinoid
receptor type 2 (CB2) agonist
Dermatomyositis –
The Phase 3 “DETERMINE” study in
dermatomyositis, a rare and life-threatening autoimmune disease
characterized by skin and muscle inflammation, is fully
enrolled.
Key Updates:
- This double-blind, randomized,
placebo-controlled, multinational study enrolled 176 patients,
which exceeded the original target of 150 patients. Approximately
60% of patients have completed Week 28 of dosing.
- There have been recent changes in
the dermatomyositis competitive landscape with studies that are
shorter than one year using the same efficacy endpoint as
DETERMINE. Therefore, Corbus will
submit a protocol amendment to the FDA and other regulatory
agencies to shorten the treatment duration of
DETERMINE to 28 weeks from one
year. The last subject visit through 28 weeks is expected in March
2021 with topline data to be reported shortly thereafter.
- Baseline patient demographics and
disease characteristics were presented at the American College of
Rheumatology’s (ACR) Convergence 2020, which took place November
5–9, 2020. ACR poster is available online.
- A separate presentation at ACR
Convergence 2020 showed that CB2 expression was increased on immune
cells in lesional skin from dermatomyositis subjects in the
lenabasum Phase 2 study. Treatment with lenabasum was associated
with reduction in immune cell infiltrates, CB2 expression and
inflammatory cytokine production in lesional skin from these
subjects. ACR poster is available online.
- There is significant unmet need for
new medicines to achieve disease control in dermatomyositis because
of the limitations of current treatment options. Dermatomyositis
affects approximately 80,000 people in North America, EU, and
Japan.
- Systemic Sclerosis – Topline data
from the RESOLVE-1 Phase 3 study of lenabasum for the treatment of
systemic sclerosis were announced on September 8, and additional
data were announced on November 9. RESOLVE-1 was a 52-week,
multinational, double-blind, placebo-controlled study that enrolled
365 patients with diffuse cutaneous systemic sclerosis. It was the
first large, late-stage clinical study in diffuse cutaneous
systemic sclerosis that allowed patients to remain on a wide range
of background immunosuppressive therapy.
Key Findings:
- Topline data remain as previously
reported.
- Exploratory post-hoc analyses
showed lenabasum treatment was associated with a benefit in lung
function (forced vital capacity) in subjects on established
background immunosuppressant therapies (greater than 2 years).
- Focusing on FVC in patients on
established immunosuppressant therapies could address a key unmet
need, which Corbus believes represent a potential commercial
opportunity.
- Systemic sclerosis is a rare,
life-threatening autoimmune disease affecting up to 75K
Americans.
Next Steps:
- The Company is continuing to
analyze the data and will consider the potential for an additional
study based on results of these analyses.
- Cystic Fibrosis – Topline data from
the CF-002 Phase 2b study of lenabasum for treatment of CF were
announced on October 6 and presented at the North American Cystic
Fibrosis Conference (NACFC) in October (NACFC Poster #817 available
here). CF-002 was a 28-week multinational, double-blind,
randomized, placebo-controlled study that dosed 426 subjects who
were at high-risk for recurrent pulmonary exacerbations (PEx). It
is the first study to enroll subjects who are prone to exacerbation
despite being on standard of care, including CFTR modulators.
Key Findings:
- Topline data remain as previously
reported.
- Lenabasum did not meet its primary
efficacy endpoint in the study.
- Lenabasum was well tolerated with
no new safety findings.
- Exploratory post-hoc analyses
revealed unexpectedly low PEx rates in subjects from five eastern
European countries (21% of total subjects) who received placebo.
Pulmonary exacerbations rates in these subjects were 85% lower than
in subjects from other countries.
- Exploratory post-hoc analyses in
subjects with similar FEV1% predicted at baseline and similar
treatment with CFTR-modulators suggested evidence of clinical
benefit of lenabasum.
- PEx remains a significant burden in
people with CF even with current standard therapies, including
antibiotics and CFTR modulators.
Next Steps:
- Further analysis of the data is
underway to determine potential next steps.
- Systemic Lupus Erythematosus (SLE)
– The Phase 2b study is ongoing. The study, funded and managed by
the National Institutes of Health (NIH), is enrolling at 15 sites
in the U.S., with enrollment expected to be completed in the first
half of 2021.
Pipeline Updates:
- Corbus has identified several
compounds from its CB1 inverse agonist program which the Company
believes has more promising physicochemical and pharmacokinetic
properties than CRB-4001. The Company is shifting its focus to
prioritize development of these compounds and not continuing with
CRB-4001. The Company is also looking for attractive external
assets that could have a strong synergy with is organizational
capabilities, pipeline, and expertise in immunology. Corbus will
provide an update at its next R&D day.
Corporate Updates:
- On October 8, Corbus announced a
reduction in workforce and restructuring of its operations designed
to reduce costs and reallocate resources towards its lenabasum
clinical development program in dermatomyositis and systemic lupus
erythematosus, as well as the Company’s pipeline of other novel
ECS-targeting drug candidates. The restructuring, which included
cost reductions, was intended to extend the Company’s cash runway,
and, together with the shortening of the DM study to 28 weeks, is
designed to extend the Company’s cash runaway beyond the second
quarter of 2022.
Financial Results for Third Quarter
Ended September 30, 2020:
For the quarter ended September 30, 2020, the
Company reported a net loss of approximately $34.9 million or a net
loss per diluted share of $0.43, compared to a net loss of
approximately $20.8 million or net loss per diluted share of $0.32
for the quarter ended September 30, 2019.
For the quarter ended September 30, 2020,
revenue decreased by approximately $1.4 million from the third
quarter of 2019 to $1.2 million, due primarily to revenue
recognized under the Cystic Fibrosis Program Related Investment
Agreement.
Operating expenses for the quarter ended
September 30, 2020 increased by approximately $7.5 million to $35.2
million. The increase was primarily attributable to increased
clinical trial costs.Corbus expects its cash and cash equivalents
on hand of approximately $81.9 million at September 30, 2020
together with proceeds from the expected final $2.5 million
milestone payment from the Cystic Fibrosis Foundation and
anticipated foreign tax credits to fund operations and its current
clinical plan beyond the second quarter of 2022.
Conference Call and Webcast
Information:
Corbus management will host a conference call
and webcast presentation for investors, analysts, and other
interested parties today, Tuesday, November 10, 2020, at 8:30 a.m.
ET.
To participate on the call, please dial (877)
407-3978 (domestic) or (412) 902-0039 (international). The live
webcast will be accessible on the Events page of the Investors
section of the Corbus website, www.corbuspharma.com, and will be
archived for 90 days.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a
clinical-stage company focused on the development and
commercialization of novel medicines designed to target the
endocannabinoid system. The Company’s lead product candidate,
lenabasum, is a novel, oral, selective cannabinoid receptor type 2
(CB2) agonist designed to provide an alternative to
immunosuppressive medications in the treatment of chronic
inflammatory and fibrotic diseases. Lenabasum is currently being
evaluated in dermatomyositis and systemic lupus erythematosus.
Corbus is also developing a pipeline of other preclinical drug
candidates from its endocannabinoid system platform.
Lenabasum is not approved for the treatment of
any indication. For more information on Corbus’ clinical programs,
please visit here.
For more information, visit
http://www.corbuspharma.com/, and connect with us on Twitter,
LinkedIn, and Facebook.
Forward-Looking Statements
This press release contains certain
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934 and Private Securities Litigation Reform Act, as
amended, including those relating to the Company's restructuring,
trial results, product development, clinical and regulatory
timelines, market opportunity, competitive position, possible or
assumed future results of operations, business strategies,
potential growth opportunities and other statements that are
predictive in nature. These forward-looking statements are based on
current expectations, estimates, forecasts and projections about
the industry and markets in which we operate and management's
current beliefs and assumptions.
These statements may be identified by the use of
forward-looking expressions, including, but not limited to,
"expect," "anticipate," "intend," "plan," "believe," "estimate,"
"potential,” "predict," "project," "should," "would" and similar
expressions and the negatives of those terms. These statements
relate to future events or our financial performance and involve
known and unknown risks, uncertainties, and other factors,
including the potential impact of the recent COVID-19 pandemic and
the potential impact of sustained social distancing efforts, on our
operations, clinical development plans and timelines, which may
cause actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Such
factors include those set forth in the Company's filings with the
Securities and Exchange Commission. Prospective investors are
cautioned not to place undue reliance on such forward-looking
statements, which speak only as of the date of this press release.
The Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Corbus Pharmaceuticals Holdings,
Inc.Condensed Consolidated Balance
Sheets
|
|
September 30, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
|
(unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
81,870,651 |
|
|
$ |
31,748,686 |
|
Restricted cash |
|
|
350,000 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
2,177,383 |
|
|
|
3,724,932 |
|
Contract asset |
|
|
960,091 |
|
|
|
2,681,065 |
|
Total current assets |
|
|
85,358,125 |
|
|
|
38,154,683 |
|
Restricted cash |
|
|
669,900 |
|
|
|
— |
|
Property and equipment,
net |
|
|
4,402,022 |
|
|
|
5,083,865 |
|
Operating lease right of use
asset |
|
|
5,396,248 |
|
|
|
5,818,983 |
|
Other assets |
|
|
13,041 |
|
|
|
84,968 |
|
Total assets |
|
$ |
95,839,336 |
|
|
$ |
49,142,499 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Notes payable |
|
$ |
— |
|
|
$ |
752,659 |
|
Accounts payable |
|
|
11,080,717 |
|
|
|
11,091,363 |
|
Accrued expenses |
|
|
28,593,049 |
|
|
|
22,447,939 |
|
Derivative liability |
|
|
757,000 |
|
|
|
— |
|
Operating lease liabilities, current |
|
|
972,464 |
|
|
|
595,745 |
|
Total current liabilities |
|
|
41,403,230 |
|
|
|
34,887,706 |
|
Long-term debt, net of debt
discount |
|
|
17,856,589 |
|
|
|
— |
|
Operating lease liabilities,
noncurrent |
|
|
7,353,765 |
|
|
|
8,097,228 |
|
Total liabilities |
|
$ |
66,613,584 |
|
|
$ |
42,984,934 |
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Preferred Stock $0.0001 par value:10,000,000 shares authorized, no
shares issued and outstanding at September 30, 2020 and December
31, 2019 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 150,000,000 shares authorized,
82,207,405 and 64,672,893 shares issued and outstanding at
September 30, 2020 and December 31, 2019, respectively |
|
|
8,220 |
|
|
|
6,467 |
|
Additional paid-in capital |
|
|
324,698,962 |
|
|
|
198,975,056 |
|
Accumulated deficit |
|
|
(295,481,430 |
) |
|
|
(192,823,958 |
) |
Total stockholders’ equity |
|
|
29,225,752 |
|
|
|
6,157,565 |
|
Total liabilities and stockholders’ equity |
|
$ |
95,839,336 |
|
|
$ |
49,142,499 |
|
Corbus Pharmaceuticals Holdings,
Inc.Consolidated Statements of
Operations(Unaudited)
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenue from awards and
licenses |
|
$ |
1,230,621 |
|
|
$ |
2,589,783 |
|
|
$ |
3,279,026 |
|
|
$ |
33,570,048 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
27,522,989 |
|
|
|
22,152,001 |
|
|
|
82,156,926 |
|
|
|
66,117,114 |
|
General and administrative |
|
|
7,681,573 |
|
|
|
5,534,493 |
|
|
|
23,120,020 |
|
|
|
17,367,202 |
|
Total operating expenses |
|
|
35,204,562 |
|
|
|
27,686,494 |
|
|
|
105,276,946 |
|
|
|
83,484,316 |
|
Operating loss |
|
|
(33,973,941 |
) |
|
|
(25,096,711 |
) |
|
|
(101,997,920 |
) |
|
|
(49,914,268 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(4,972 |
) |
|
|
4,109,338 |
|
|
|
4,005 |
|
|
|
4,109,338 |
|
Interest income (expense), net |
|
|
(454,319 |
) |
|
|
292,854 |
|
|
|
(348,654 |
) |
|
|
1,076,166 |
|
Change in fair value of derivative liability |
|
|
(211,000 |
) |
|
|
- |
|
|
|
(211,000 |
) |
|
|
- |
|
Foreign currency exchange loss, net |
|
|
(251,117 |
) |
|
|
(96,282 |
) |
|
|
(103,903 |
) |
|
|
(144,193 |
) |
Other income (expense), net |
|
|
(921,408 |
) |
|
|
4,305,910 |
|
|
|
(659,552 |
) |
|
|
5,041,311 |
|
Net loss |
|
$ |
(34,895,349 |
) |
|
$ |
(20,790,801 |
) |
|
$ |
(102,657,472 |
) |
|
$ |
(44,872,957 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.32 |
) |
|
$ |
(1.37 |
) |
|
$ |
(0.71 |
) |
Weighted average number of
common shares outstanding, basic and diluted |
|
|
81,879,119 |
|
|
|
64,660,017 |
|
|
|
75,037,418 |
|
|
|
63,638,447 |
|
Corbus Pharmaceuticals Contacts:
Ted Jenkins, Senior Director, Investor Relations and Corporate
Communications Phone: +1 (617) 415-7745 Email:
ir@corbuspharma.com
Lindsey Smith, Director, Investor Relations and Corporate
Communications Phone: +1 (617) 415-7749 Email:
mediainfo@corbuspharma.com
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