- Promising pre-clinical data generated for CRB-601 across
several tumor models as monotherapy and in combination with
anti-PD1 therapy
- IND submission for CRB-601 is on-track for the first half of
2023
- Expanding immuno-oncology pipeline through strategic
transactions remains key priority
- Cash and investments on hand of $86.8
million funds operations into the first quarter of
2024
NORWOOD,
Mass., May 10, 2022 /PRNewswire/ -- Corbus
Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the
"Company"), an immunology company, today provided a corporate
update and reported financial results for the first quarter of
2022.
Key Corporate and Program Updates:
- Anti-integrin monoclonal antibodies (mAb) program targeting the
inhibition of TGFβ is progressing on schedule.
-
- CRB-601, an anti-αvβ8 mAb, is being developed as a potential
treatment for solid tumors. Corbus presented the first preclinical
data for CRB-601 at the American Association for Cancer Research
(AACR) Annual Meeting in April 2022.
The poster can be viewed at: www.corbuspharma.com/AACRposter.
- The most recent data from CRB-601 will be presented on
May 11, 2022 at the New York Academy
of Sciences Frontiers in Cancer Immunotherapy Conference. This new
data demonstrates effects of CRB-601 in additional syngeneic animal
models with increasing levels of resistance to check point
inhibitors.
- Across models explored to date, CRB-601 demonstrates an
enhancement of anti-tumor activity when combined with anti PD-1
therapy compared to either single agent alone. This enhancement of
efficacy is associated with tumor infiltration of proliferating
CD4+ and CD8+ T cells in addition to NK cells and M1
macrophages.
- Collectively, this data supports the hypothesis that blockade
of local TGFb production by CRB-601 can lead to changes in immune
cell infiltration in the tumor microenvironment, potentially
enhancing the benefit of PD-1 blockade.
- IND-enabling activities for CRB-601 are ongoing and the program
is on-schedule for an IND submission in the first half of 2023.
- A lead candidate, CRB-913, has been selected for the CB1
inverse agonist program. In animal models of diet-induced obesity,
CRB-913 induced weight loss and impacted multiple metabolic
parameters, both as monotherapy and in combination with semaglutide
and tirzepatide. Corbus is seeking partnerships to advance CRB-913
into clinical studies.
- The National Institutes of Health sponsored Phase 2 study of
lenabasum in systemic lupus erythematosus has completed its last
patient visit and the clinical database has been locked. The
Company is awaiting topline results. Corbus is pursuing potential
partnerships to fund further development of lenabasum.
- A detailed update on the Corbus pipeline can be found in the
most recent Corporate Presentation available at:
ir.corbuspharma.com/presentations
"We are executing our plan to transform Corbus into a company
with a novel and diversified immuno-oncology pipeline. We're
excited about the first data to come out of our integrin program
and for the opportunity to present it at scientific conferences. We
look forward to entering the clinic in 2023," commented
Yuval Cohen, Ph.D., Chief Executive
Officer of Corbus. "We are actively engaging in business
development activities with the goal of expanding our
immuno-oncology pipeline while monetizing our ECS assets through
new partnerships."
Financial Results for First Quarter Ended March 31, 2022:
The Company reported a net loss of approximately $9.4 million, or a net loss per diluted share of
$0.08, for the three months ended
March 31, 2022, compared to a net loss of approximately
$16 million, or a net loss per
diluted share of $0.14, for the same
period in 2021.
Operating expenses decreased by $7.5
million to approximately $8.5
million for the three months ended March 31, 2022, compared to $16 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.
As of March 31, 2022, the company
has $86.8 million of cash and
investments on hand which is expected to fund operations into the
first quarter of 2024, based on the current planned
expenditures.
About Corbus
Corbus is an immunology company committed to connecting
innovation to our purpose of improving lives by developing new
medicines that target the nexus between the immune system and
cancer. Corbus' current pipeline includes anti-integrin monoclonal
antibodies that block activation of TGFβ and small molecules that
activate or inhibit the endocannabinoid system. 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.
INVESTOR CONTACT:
Sean Moran
smoran@corbuspharma.com
Corbus
Pharmaceuticals Holdings, Inc. Condensed Consolidated
Balance Sheets
|
|
|
|
March 31, 2022
|
|
|
December 31, 2021
|
|
|
|
(Unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
57,026,334
|
|
|
$
|
25,006,632
|
|
Investments
|
|
|
29,094,916
|
|
|
|
72,640,520
|
|
Restricted cash
|
|
|
192,475
|
|
|
|
192,475
|
|
Prepaid expenses and other current assets
|
|
|
2,161,860
|
|
|
|
2,365,010
|
|
Total current assets
|
|
|
88,475,585
|
|
|
|
100,204,637
|
|
Restricted
cash
|
|
|
477,425
|
|
|
|
477,425
|
|
Property and equipment,
net
|
|
|
2,210,426
|
|
|
|
2,392,696
|
|
Operating lease right
of use assets
|
|
|
4,436,376
|
|
|
|
4,609,110
|
|
Other assets
|
|
|
75,275
|
|
|
|
46,385
|
|
Total assets
|
|
$
|
95,675,087
|
|
|
$
|
107,730,253
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Notes payable
|
|
$
|
440,815
|
|
|
$
|
767,938
|
|
Accounts payable
|
|
|
2,696,810
|
|
|
|
1,782,277
|
|
Accrued expenses
|
|
|
5,496,406
|
|
|
|
10,093,312
|
|
Derivative liability
|
|
|
133,710
|
|
|
|
133,710
|
|
Operating lease liabilities, current
|
|
|
1,171,858
|
|
|
|
1,136,948
|
|
Current portion of long-term debt
|
|
|
5,178,107
|
|
|
|
3,093,344
|
|
Total current
liabilities
|
|
|
15,117,706
|
|
|
|
17,007,529
|
|
Long-term debt, net of
debt discount
|
|
|
13,728,413
|
|
|
|
15,636,275
|
|
Other long-term
liabilities
|
|
|
22,205
|
|
|
|
22,205
|
|
Operating lease
liabilities, noncurrent
|
|
|
5,651,480
|
|
|
|
5,956,217
|
|
Total liabilities
|
|
|
34,519,804
|
|
|
|
38,622,226
|
|
Stockholders'
equity
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares
authorized, no shares
issued and
outstanding at March 31, 2022 and December 31, 2021
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.0001 par value; 300,000,000 shares
authorized,
125,255,881 and
125,230,881 shares issued and outstanding at March 31,
2022 and December
31, 2021, respectively
|
|
|
12,526
|
|
|
|
12,523
|
|
Additional paid-in
capital
|
|
|
420,483,456
|
|
|
|
418,891,713
|
|
Accumulated
deficit
|
|
|
(359,171,006)
|
|
|
|
(349,733,764)
|
|
Accumulated other
comprehensive loss
|
|
|
(169,693)
|
|
|
|
(62,445)
|
|
Total stockholders' equity
|
|
|
61,155,283
|
|
|
|
69,108,027
|
|
Total liabilities and
stockholders' equity
|
|
$
|
95,675,087
|
|
|
$
|
107,730,253
|
|
Corbus
Pharmaceuticals Holdings, Inc. Condensed Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited)
|
|
|
|
|
|
For the Three Months Ended
March 31,
|
|
|
|
2022
|
|
|
2021
|
|
Revenue from
awards
|
|
$
|
—
|
|
|
$
|
647,824
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and development
|
|
|
3,286,236
|
|
|
|
10,720,823
|
|
General and administrative
|
|
|
5,230,923
|
|
|
|
5,341,197
|
|
Total operating
expenses
|
|
|
8,517,159
|
|
|
|
16,062,020
|
|
Operating
loss
|
|
|
(8,517,159)
|
|
|
|
(15,414,196)
|
|
Other income (expense),
net:
|
|
|
|
|
|
|
Other income (expense), net
|
|
|
(193,351)
|
|
|
|
(15,094)
|
|
Interest income (expense), net
|
|
|
(458,909)
|
|
|
|
(646,550)
|
|
Change in fair value of derivative liability
|
|
|
—
|
|
|
|
(6,000)
|
|
Foreign currency exchange gain (loss), net
|
|
|
(267,823)
|
|
|
|
16,672
|
|
Other income (expense),
net
|
|
|
(920,083)
|
|
|
|
(650,972)
|
|
Net loss
|
|
$
|
(9,437,242)
|
|
|
$
|
(16,065,168)
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.08)
|
|
|
$
|
(0.14)
|
|
Weighted average number
of common shares outstanding,
basic and diluted
|
|
|
125,243,242
|
|
|
|
116,344,900
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(9,437,242)
|
|
|
$
|
(16,065,168)
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable debt
securities
|
|
|
(107,248)
|
|
|
|
(28,765)
|
|
Total other comprehensive
income (loss)
|
|
|
(107,248)
|
|
|
|
(28,765)
|
|
Total comprehensive
loss
|
|
$
|
(9,544,490)
|
|
|
$
|
(16,093,933)
|
|
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SOURCE Corbus Pharmaceuticals