Corbus Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Corporate Updates
August 12 2021 - 8:05AM
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or
the “Company”), an immunology company, today provided corporate
updates and reported financial results for the second quarter of
2021.
Corporate
updates:
- Lenabasum: The primary endpoint in
the DETERMINE Phase 3 study of
lenabasum in dermatomyositis was not met, although evidence of
activity was seen in multiple endpoints. The next step for this
program is to reach agreement with the FDA on the potential path
forward in dermatomyositis. The company expects topline data from
the National Institutes of Health-sponsored Phase 2 study of
lenabasum in systemic lupus erythematosus in Q4
2021.
- Cannabinoid receptor type 1 (CB1)
program: Corbus’ CB1 inverse agonists are in preclinical
development for treatment of metabolic diseases. In an animal model
of diet-induced obesity, our most advanced candidate (CRB-556)
generates weight loss as a monotherapy, and its combination with a
GLP-1 agonist resulted in greater weight loss than with the GLP-1
inhibitor alone. Program is on track for IND in 2022.
- Cannabinoid receptor type 2
(CB2) program: Corbus’ CB2 agonists are in preclinical
development for treatment of cancer in combination with existing
therapies, such as checkpoint inhibitors. Corbus compounds inhibit
tumor cells proliferation in vitro and have activity as monotherapy
in animal models of cancer. Key preclinical data are expected
in Q3 2021 that will guide the path to an IND.
- Anti-TGFβ integrin monoclonal
antibody (mAb) program:
- New data demonstrate CRB-601 is highly effective at inhibiting
αvβ8-mediated activation of diffusible and non-diffusible TGFβ in
vitro, has preliminary efficacy in the syngeneic animal model of
lung cancer (Lewis lung carcinoma model), and appears to be
significantly more effective (75x) in vitro than ADWA-11
(PF-06940434), an anti-αvβ8 mAb being tested in a Phase 1 study
sponsored by Pfizer.
- CRB-601 is also up to 10x more potent in vitro than its
precursor mAb, C6D4.
- Pre-IND work has commenced, and the program is on schedule for
anticipated IND in late 2022.
- CRB-602 (anti-αvβ6/8 mAb) for
fibrotic diseases and cancer:
- CRB-602 inhibits both αvβ6 and αvβ8 and is in preclinical
development for fibrotic diseases and cancer.
- Program is on schedule for an anticipated IND in early
2023.
Yuval Cohen, Ph.D., Chief Executive Officer
said, “Corbus recently made significant progress on our plan to
expand our pipeline by licensing two integrin-targeting mAbs that
we believe offer a promising approach to inhibiting TGFβ. We are on
track to progress these assets along with our small molecules that
activate or inhibit the endocannabinoid system into the clinic next
year.”
Dr. Cohen continued, “With our strong financial
position of approximately $114M of cash and investments on hand, we
have the resources in place to advance our diversified
pipeline.”
Financial Results for First Quarter Ended
June 30,
2021:
Revenue from awards and licenses was
approximately $137,000 for the three months ended June 30, 2021,
compared to approximately $286,000 in the comparable period in
2020.
Operating expenses decreased by $21.6 million to
approximately $16.8 million for the three months ended June 30,
2021, compared to $38.4 million in the comparable period in the
prior year. The decrease was primarily attributable to decreased
clinical trial and drug manufacturing costs, and an overall
reduction in compensation expense.
The Company reported a net loss of approximately
$17.1 million, or a net loss per diluted share of $0.15, for the
three months ended June 30, 2021, compared to a net loss of
approximately $38.1 million, or a net loss per diluted share of
$0.52, for the same period in 2020.
Subsequent to June 30th the Company received a
refundable foreign tax credit of approximately $12.2 million. As of
August 10, 2021, the company has $114.3 million of cash on hand
which is expected to fund operations into the first quarter of
2024, based on the current planned expenditures.
About Corbus
Corbus is committed to connecting innovation to
our purpose of improving lives by developing new medicines that
target inflammation, fibrosis, metabolism and immuno-oncology, by
building upon our underlying expertise in immunology. Corbus’
current pipeline includes small molecules that activate or inhibit
the endocannabinoid system and anti-integrin monoclonal antibodies
that block activation of TGFβ. Corbus is headquartered in Norwood,
Massachusetts. For more information on Corbus, visit
corbuspharma.com. 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 Contact:
Lindsey Smith, Director, Investor Relations and Corporate
Communications Phone: +1 (617) 415-7749 Investors:
ir@corbuspharma.comMedia: mediainfo@corbuspharma.com
Corbus Pharmaceuticals
Holdings, Inc.Condensed Consolidated Balance
Sheets
|
|
June 30, 2021 (Unaudited) |
|
|
December 31, 2020 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
36,080,292 |
|
|
$ |
85,433,441 |
|
Marketable securities |
|
|
70,371,664 |
|
|
|
— |
|
Restricted cash |
|
|
100,000 |
|
|
|
350,000 |
|
Stock subscriptions receivable |
|
|
- |
|
|
|
960,033 |
|
Prepaid expenses and other current assets |
|
|
2,625,425 |
|
|
|
3,712,861 |
|
Contract asset |
|
|
2,402,678 |
|
|
|
1,618,296 |
|
Total current assets |
|
|
111,580,059 |
|
|
|
92,074,631 |
|
Restricted cash |
|
|
569,900 |
|
|
|
669,900 |
|
Property and equipment,
net |
|
|
3,517,677 |
|
|
|
4,067,837 |
|
Operating lease right of use
assets |
|
|
4,938,889 |
|
|
|
5,248,525 |
|
Other assets |
|
|
2,614 |
|
|
|
234,038 |
|
Total assets |
|
$ |
120,609,139 |
|
|
$ |
102,294,931 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Notes payable |
|
$ |
102,693 |
|
|
$ |
710,158 |
|
Accounts payable |
|
|
1,878,244 |
|
|
|
7,381,183 |
|
Accrued expenses |
|
|
15,087,681 |
|
|
|
22,005,432 |
|
Derivative liability |
|
|
599,000 |
|
|
|
797,000 |
|
Operating lease liabilities, current |
|
|
1,069,181 |
|
|
|
1,004,063 |
|
Total current liabilities |
|
|
18,736,799 |
|
|
|
31,897,836 |
|
Long-term debt, net of debt
discount |
|
|
18,373,099 |
|
|
|
18,029,005 |
|
Operating lease liabilities,
noncurrent |
|
|
6,540,040 |
|
|
|
7,093,165 |
|
Total liabilities |
|
|
43,649,938 |
|
|
|
57,020,006 |
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized,
no shares issued and outstanding at June 30, 2021 and December 31,
2020 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 300,000,000 shares authorized,
125,083,006 shares issued and outstanding at June 30, 2021 and
150,000,000 shares authorized, and 98,852,696 shares issued and
outstanding at December 31, 2020 |
|
|
12,508 |
|
|
|
9,885 |
|
Additional paid-in capital |
|
|
414,249,029 |
|
|
|
349,358,378 |
|
Accumulated other comprehensive loss |
|
|
(5,454 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(337,296,882 |
) |
|
|
(304,093,338 |
) |
Total stockholders’ equity |
|
|
76,959,201 |
|
|
|
45,274,925 |
|
Total liabilities and stockholders’ equity |
|
$ |
120,609,139 |
|
|
$ |
102,294,931 |
|
Corbus Pharmaceuticals
Holdings, Inc.Condensed Consolidated Statements of
Operations (Unaudited)
|
|
For the Three Months Ended |
|
|
For the Six Months Ended |
|
|
|
|
June 30, |
|
|
June 30, |
|
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
Revenue from awards and
licenses |
|
$ |
136,558 |
|
|
$ |
286,346 |
|
|
$ |
784,382 |
|
|
$ |
2,048,405 |
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
11,265,220 |
|
|
|
30,686,071 |
|
|
|
21,986,043 |
|
|
|
54,633,937 |
|
|
|
General and administrative |
|
|
5,572,397 |
|
|
|
7,738,968 |
|
|
|
10,913,594 |
|
|
|
15,438,447 |
|
|
|
Total operating expenses |
|
|
16,837,617 |
|
|
|
38,425,039 |
|
|
|
32,899,637 |
|
|
|
70,072,384 |
|
|
|
Operating loss |
|
|
(16,701,059 |
) |
|
|
(38,138,693 |
) |
|
|
(32,115,255 |
) |
|
|
(68,023,979 |
) |
|
|
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(227,609 |
) |
|
|
— |
|
|
|
(242,703 |
) |
|
|
|
|
|
Interest income (expense), net |
|
|
(401,170 |
) |
|
|
12,649 |
|
|
|
(1,047,720 |
) |
|
|
114,642 |
|
|
|
Change in fair value of derivative liability |
|
|
204,000 |
|
|
|
— |
|
|
|
198,000 |
|
|
|
|
|
|
Foreign currency exchange gain (loss), net |
|
|
(12,538 |
) |
|
|
20,721 |
|
|
|
4,134 |
|
|
|
147,214 |
|
|
|
Other income (expense), net |
|
|
(437,317 |
) |
|
|
33,370 |
|
|
|
(1,088,289 |
) |
|
|
261,856 |
|
|
|
Net loss |
|
$ |
(17,138,376 |
) |
|
$ |
(38,105,323 |
) |
|
$ |
(33,203,544 |
) |
|
$ |
(67,762,123 |
) |
|
|
Net loss per share, basic and
diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.95 |
) |
|
|
Weighted average number of
common shares outstanding, basic and diluted |
|
|
116,364,131 |
|
|
|
73,885,548 |
|
|
|
120,722,622 |
|
|
|
71,578,975 |
|
|
|
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