Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or
the “Company”), a clinical-stage drug development company
pioneering transformative medicines that target the endocannabinoid
system, today reported financial results for the fourth quarter and
year-end 2020. The Company also provided clinical and pipeline
updates.
Yuval Cohen, Ph.D., Chief Executive Officer
said, “We are making progress on our plans to advance development
of our internal compounds and expand our pipeline. We look forward
to topline results from our
DETERMINE Phase 3 study of
lenabasum in dermatomyositis in the second quarter. Our CB1 inverse
agonist program focusing on metabolic diseases and our CB2 agonist
program focusing on oncology continue to progress pre-clinically,
and we project to initiate clinical studies next year. We are
determined to expand our pipeline and are evaluating a number
of potential assets.”
Dr. Cohen continued, “We are fortunate to be in
a strong financial position with approximately $127M of cash on
hand, which is expected to fund the Company into the first quarter
of 2024.”
Clinical Program Updates:
Lenabasum: a novel, oral, selective cannabinoid
receptor type 2 (CB2) agonist
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● |
Dermatomyositis – The Phase 3
“DETERMINE” study is a
double-blind, randomized, placebo-controlled, international study
of safety and efficacy of lenabasum in adult dermatomyositis
patients. This study enrolled 176 subjects, and all subjects are
expected to complete Week 28 of the study this month. The primary
efficacy endpoint is Total Improvement Score at Week 28, comparing
lenabasum 20 mg twice per day and placebo groups. Topline data are
on schedule for Q2 2021. |
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Dermatomyositis is a rare and life-threatening autoimmune disease
characterized by skin and muscle inflammation. Dermatomyositis
affects approximately 80,000 people in North America, EU, and
Japan. There is a significant unmet need for safer and more
effective treatments in dermatomyositis because of the limitations
of current treatment options. |
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Systemic Lupus Erythematosus – This Phase 2b study is a
double-blind, randomized, placebo-controlled, U.S.-based study of
safety and efficacy of lenabasum in adult systemic lupus
erythematosus patients. The ongoing study is expected to dose 100
subjects at 15 sites. Enrollment is expected to be completed in Q2
2021, and topline results are expected in the second half of 2021.
The primary efficacy endpoint is change in maximum daily pain
numerical rating score at Week 12, comparing lenabasum groups to
placebo. The secondary endpoints include change from baseline in
Active Lupus Musculoskeletal Disease Activity (BILAG-2004) and
Change from baseline in Lupus Disease Activity (SELENA-SLEDAI
Score). The National Institutes of Health is funding and managing
this trial. |
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Systemic Sclerosis – In 2020, lenabasum did not meet the primary
endpoint in the RESOLVE-1 Phase 3 study of lenabasum in systemic
sclerosis. Currently no systemic sclerosis patients are being
treated with lenabasum. The Company is preparing the data from the
RESOLVE-1 study for publication and will decide on the next steps
in the development process pending the outcome of the DETERMINE
study. |
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Cystic Fibrosis – In 2020, lenabasum did not meet the primary
endpoint in the Phase 2b study of lenabasum in cystic fibrosis.
Corbus is preparing the cystic fibrosis study data for publication,
but currently it does not have plans for additional clinical
studies. |
Pipeline Updates:
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● |
The cannabinoid receptor type 1 (CB1) inverse agonist program is in
preclinical development for potential treatment of metabolic
disorders such as obesity, diabetic nephropathy, diabetic
retinopathy, and nonalcoholic steatohepatitis. Several compounds
have demonstrated positive data in preclinical models of
diet-induced obesity. These data were presented at the New York
Academy of Sciences webinar in January 2020. Corbus is moving
toward candidate selection and IND-enabling studies, and intends to
initiate clinical studies in 2022. |
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The cannabinoid receptor type 2 (CB2) agonist program is in
preclinical development for potential treatment of cancer,
investigating single agent activity and in combination with other
cancer therapies such as checkpoint inhibitors. Several compounds
have demonstrated positive data in preclinical models of solid
tumors. These data were presented at the New York Academy of
Sciences webinar in January 2020. The Company is moving toward
candidate selection and IND-enabling studies, and intends to
initiate clinical studies in 2022. |
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● |
Corbus is actively engaging with potential partners to expand its
pipeline through acquisition of external assets. The Company is
focusing on biology beyond the endocannabinoid system and new
indications that will still leverage its expertise and capabilities
within immunology. |
Financial Results for Fourth Quarter and
Year-End December 31, 2020:
Revenue from awards and licenses was $700,000
for the three months ended December 31, 2020, compared to $2.6
million in the comparable period in 2019. For the year ended
December 31, 2020, revenue from awards and licenses was $3.9
million, compared to $36.1 million in the comparable period in
2019. Revenue for the year ended December 31, 2019 included a $27
million upfront payment received from Kaken Pharmaceutical Co.,
Ltd. for a license to commercialize and market lenabasum in
Japan.
Operating expenses were $21.5 million for the three months ended
December 31, 2020, compared to $29.8 million in the comparable
period in the prior year. For the year ended December 31, 2020,
operating expenses were $126.7 million, compared to $113.2 million
in the comparable period in the prior year. Increased expenses for
the year were attributable to increased compensation costs,
increased clinical trial costs and restructuring costs. Decreased
operating expenses quarter over quarter were attributable to the
completion of systemic sclerosis and cystic fibrosis in September
and October of 2020, respectively. The Company expects expenses to
decline in 2021 as a result of the completion in 2020 of clinical
trials in systemic sclerosis and cystic fibrosis.
The Company reported a net loss of approximately
$8.6 million or a net loss per diluted share of $0.10, for the
three months ended December 31, 2020, compared to a net loss of
approximately $26.6 million, or a net loss per diluted share of
$0.41, for the same period in 2019. For the year ended December 31,
2020, the Company reported a net loss of approximately $111.3
million, or a net loss per diluted share of $1.42, compared to a
net loss of approximately $71.5 million, or a net loss per diluted
share of $1.12, for the same period in 2019.
Cash and cash equivalents were $85.4 million at
December 31, 2020. During the fourth quarter of 2020 the Company
raised $20.8 million in net proceeds from the Company’s ATM
facility, and in 2021 to date, the Company has raised $58.9 million
in net proceeds from the Company’s ATM facility. The $127 million
of cash on hand at March 15, 2021 is expected to fund operations
into the first quarter of 2024 based on the current planned
expenditures.
Conference Call and Webcast
Information:
Corbus management will host a conference call
and webcast presentation for investors, analysts, and other
interested parties today, Monday, March 15, 2021, 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 statement 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
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December 31, |
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December 31, |
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2020 |
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2019 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
|
$ |
85,433,441 |
|
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$ |
31,748,686 |
|
Restricted cash |
|
$ |
350,000 |
|
|
|
— |
|
Stock subscriptions receivable |
|
$ |
960,033 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
$ |
3,712,861 |
|
|
|
3,724,932 |
|
Contract asset |
|
$ |
1,618,296 |
|
|
|
2,681,065 |
|
Total current assets |
|
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92,074,631 |
|
|
|
38,154,683 |
|
Restricted cash |
|
|
669,900 |
|
|
|
— |
|
Property and equipment,
net |
|
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4,067,837 |
|
|
|
5,083,865 |
|
Operating lease right of use
asset |
|
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5,248,525 |
|
|
|
5,818,983 |
|
Other assets |
|
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234,038 |
|
|
|
84,968 |
|
Total assets |
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$ |
102,294,931 |
|
|
$ |
49,142,499 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Notes payable |
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$ |
710,158 |
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$ |
752,659 |
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Accounts payable |
|
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7,381,183 |
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|
|
11,091,363 |
|
Accrued expenses |
|
|
22,005,432 |
|
|
|
22,447,939 |
|
Derivative liability |
|
|
797,000 |
|
|
|
— |
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Operating lease liabilities, current |
|
|
1,004,063 |
|
|
|
595,745 |
|
Total current liabilities |
|
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31,897,836 |
|
|
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34,887,706 |
|
Long-term debt, net of debt
discount |
|
|
18,029,005 |
|
|
|
— |
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Operating lease liabilities,
noncurrent |
|
|
7,093,165 |
|
|
|
8,097,228 |
|
Total liabilities |
|
|
57,020,006 |
|
|
|
42,984,934 |
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Preferred Stock $0.0001 par value:10,000,000 shares authorized, no
shares issued and outstanding at December 31, 2020 and December 31,
2019 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 150,000,000 shares authorized,
98,088,253 and 64,672,893 shares issued and outstanding at
September 30, 2020 and December 31, 2019, respectively |
|
|
9,885 |
|
|
|
6,467 |
|
Additional paid-in capital |
|
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349,358,378 |
|
|
|
198,975,056 |
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Accumulated deficit |
|
|
(304,093,338 |
) |
|
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(192,823,958 |
) |
Total stockholders’ equity |
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45,274,925 |
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|
|
6,157,565 |
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Total liabilities and stockholders’ equity |
|
$ |
102,294,931 |
|
|
$ |
49,142,499 |
|
Corbus Pharmaceuticals Holdings, Inc.
Consolidated Statements of
Operations(Unaudited)
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For the Three Months Ended |
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For the Twelve Months Ended |
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|
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December 31, |
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December 31, |
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|
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2020 |
|
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2019 |
|
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2020 |
|
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2019 |
|
Revenue from awards and
licenses |
|
$ |
658,204 |
|
|
$ |
2,573,519 |
|
|
|
3,937,230 |
|
|
$ |
36,143,568 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
16,110,287 |
|
|
|
23,487,675 |
|
|
|
98,267,213 |
|
|
|
89,604,790 |
|
General and administrative |
|
|
5,360,231 |
|
|
|
6,276,155 |
|
|
|
28,480,250 |
|
|
|
23,643,357 |
|
Total operating expenses |
|
|
21,470,518 |
|
|
|
29,763,830 |
|
|
|
126,747,463 |
|
|
|
113,248,147 |
|
Operating loss |
|
|
(20,812,314 |
) |
|
|
(27,190,310 |
) |
|
|
(122,810,233 |
) |
|
|
(77,104,579 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Other income (expense), net |
|
|
13,266,206 |
|
|
|
472,500 |
|
|
|
13,270,211 |
|
|
|
4,581,838 |
|
Interest income (expense), net |
|
|
(679,704 |
) |
|
|
151,477 |
|
|
|
(1,028,359 |
) |
|
|
1,227,643 |
|
Change in fair value of derivative liability |
|
|
(40,000 |
) |
|
|
- |
|
|
|
(251,000 |
) |
|
|
- |
|
Foreign currency exchange loss, net |
|
|
(346,058 |
) |
|
|
(14,428 |
) |
|
|
(449,999 |
) |
|
|
(158,620 |
) |
Other income (expense), net |
|
|
12,200,444 |
|
|
|
609,549 |
|
|
|
11,540,853 |
|
|
|
5,650,861 |
|
Net loss |
|
$ |
(8,611,870 |
) |
|
$ |
(26,580,761 |
) |
|
|
(111,269,380 |
) |
|
$ |
(71,453,718 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.10 |
) |
|
$ |
(0.41 |
) |
|
|
(1.42 |
) |
|
$ |
(1.12 |
) |
Weighted average number of
common shares outstanding, basic and diluted |
|
|
87,207,293 |
|
|
|
64,660,017 |
|
|
|
78,133,289 |
|
|
|
63,899,184 |
|
Corbus Pharmaceuticals
Contacts: Ted Jenkins, Senior Director, Investor Relations
and Corporate CommunicationsPhone: +1 (617) 415-7745Email:
ir@corbuspharma.com
Lindsey Smith, Director, Investor Relations and
Corporate CommunicationsPhone: +1 (617) 415-7749Email:
mediainfo@corbuspharma.com
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