- 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 mid-2023
- Expanding immuno-oncology pipeline through strategic
transactions remains key priority
- Cash and investments on hand of $74
million funds operations into the first quarter of
2024
NORWOOD,
Mass., Aug. 9, 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 antibody (mAb) programs targeting the
inhibition of TGFβ are progressing on schedule
-
- CRB-601, an anti-αvβ8 mAb, is being developed as a potential
treatment for solid tumors.
- 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 activity 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 mid-2023.
- Recent clinical updates from other investigational therapies
also targeting latent TGFb reinforce the promise of this novel
approach in oncology.
- CB1 inverse agonist program for obesity / metabolism in active
partnering discussions
-
- CRB-913, the lead pre-clinical candidate, has demonstrated both
weight loss and improvement in multiple metabolic parameters, as
monotherapy and in combination with semaglutide and tirzepatide in
animal models of diet-induced obesity.
- This data has been accepted for an oral presentation at the
upcoming annual meeting of the European Association for the Study
of Diabetes (EASD) in September.
- Corbus is exploring partnerships to advance CRB-913 into
clinical studies.
- The National Institutes of Health has informed the Company that
the Phase 2 study conducted by Dr. Meggan
Mackay at the Feinstein Institutes for Medical Research with
the Autoimmune Centers of Excellence and sponsored by the National
Institute of Allergy and Infectious Diseases evaluating the
efficacy, safety, and tolerability of lenabasum in Systemic Lupus
Erythematosus (SLE) did not meet its primary endpoint of a
statistical improvement in the Numerical Rating Scale (NRS) for
pain associated with musculoskeletal inflammation. However, data
for the recognized regulatory and clinical endpoints for SLE
(BILAG-2004 and the SELENA-SLEDAI) are still pending. Topline data
is planned for presentation at an upcoming rheumatology
congress.
- A detailed update on the Corbus pipeline can be found in the
most recent Corporate Presentation available at:
www.ir.corbuspharma.com/presentations
"We are continuing the transformation of Corbus into a company
with a novel and diversified immuno-oncology pipeline and look
forward to sharing additional data updates from our integrin
programs later this year. We are greatly encouraged by recent
clinical updates from the field of latent TGFb inhibition that
point to a potential breakthrough in how this key cytokine could be
successfully targeted in oncology," commented Yuval Cohen, Ph.D., Chief Executive Officer of
Corbus. "We are actively engaged in business development activities
with the goal of expanding our pipeline while also bringing in
non-dilutive funding by monetizing our ECS assets through new
partnerships."
Financial Results for First Quarter Ended June 30, 2022:
The Company reported a net loss of approximately $13.2 million, or a net loss per diluted share of
$0.11, for the three months ended
June 30, 2022, compared to a net loss
of approximately $17.1 million, or a
net loss per diluted share of $0.15,
for the same period in 2021.
Operating expenses for Q2 2022 included a one-time charge of
$5 million to settle litigation.
Operating expenses decreased by $9.5
million to approximately $7.3
million for the three months ended June 30, 2022, compared to $16.8 million in the comparable period in the
prior year, excluding the one-time charge. The decrease was
primarily attributable to decreased clinical trial and drug
manufacturing costs, and an overall reduction in compensation
expense.
As of June 30, 2022, the Company
has $74 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 helping people
defeat serious illness by bringing innovative scientific approaches
to well understood biological pathways. 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 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.
INVESTOR CONTACT:
Sean
Moran
smoran@corbuspharma.com
Corbus Pharmaceuticals Holdings,
Inc.
Condensed
Consolidated Balance Sheets
|
|
|
|
June 30,
2022
|
|
|
December 31,
2021
|
|
|
|
(Unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
25,770,665
|
|
|
$
|
25,006,632
|
|
Investments
|
|
|
47,532,557
|
|
|
|
72,640,520
|
|
Restricted
cash
|
|
|
192,475
|
|
|
|
192,475
|
|
Prepaid expenses and
other current assets
|
|
|
1,742,273
|
|
|
|
2,365,010
|
|
Total current
assets
|
|
|
75,237,970
|
|
|
|
100,204,637
|
|
Restricted
cash
|
|
|
477,425
|
|
|
|
477,425
|
|
Property and equipment,
net
|
|
|
1,989,007
|
|
|
|
2,392,696
|
|
Operating lease right
of use assets
|
|
|
4,258,077
|
|
|
|
4,609,110
|
|
Other assets
|
|
|
104,165
|
|
|
|
46,385
|
|
Total
assets
|
|
$
|
82,066,644
|
|
|
$
|
107,730,253
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Notes
payable
|
|
$
|
110,705
|
|
|
$
|
767,938
|
|
Accounts
payable
|
|
|
1,986,622
|
|
|
|
1,782,277
|
|
Accrued
expenses
|
|
|
4,716,422
|
|
|
|
10,093,312
|
|
Derivative
liability
|
|
|
133,710
|
|
|
|
133,710
|
|
Operating lease
liabilities, current
|
|
|
1,207,471
|
|
|
|
1,136,948
|
|
Current portion of
long-term debt
|
|
|
7,474,846
|
|
|
|
3,093,344
|
|
Total current
liabilities
|
|
|
15,629,776
|
|
|
|
17,007,529
|
|
Long-term debt, net of
debt discount
|
|
|
11,612,237
|
|
|
|
15,636,275
|
|
Other long-term
liabilities
|
|
|
22,205
|
|
|
|
22,205
|
|
Operating lease
liabilities, noncurrent
|
|
|
5,332,569
|
|
|
|
5,956,217
|
|
Total
liabilities
|
|
|
32,596,787
|
|
|
|
38,622,226
|
|
Stockholders'
equity
|
|
|
|
|
|
|
Preferred stock,
$0.0001 par value; 10,000,000 shares authorized, no shares
issued and outstanding at June 30, 2022 and December
31, 2021
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.0001
par value; 300,000,000 shares authorized,
125,268,381 and 125,230,881 shares issued and
outstanding at June 30, 2022 and
December 31, 2021, respectively
|
|
|
12,527
|
|
|
|
12,523
|
|
Additional paid-in
capital
|
|
|
421,996,544
|
|
|
|
418,891,713
|
|
Accumulated
deficit
|
|
|
(372,419,894)
|
|
|
|
(349,733,764)
|
|
Accumulated other
comprehensive loss
|
|
|
(119,320)
|
|
|
|
(62,445)
|
|
Total stockholders'
equity
|
|
|
49,469,857
|
|
|
|
69,108,027
|
|
Total liabilities and
stockholders' equity
|
|
$
|
82,066,644
|
|
|
$
|
107,730,253
|
|
Corbus Pharmaceuticals Holdings,
Inc.
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(Unaudited)
|
|
|
|
|
|
For the Three
Months
Ended June 30,
|
|
|
For the Six
Months
Ended June 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Revenue from
awards
|
|
$
|
—
|
|
|
$
|
136,558
|
|
|
$
|
—
|
|
|
$
|
784,382
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
2,499,642
|
|
|
|
11,265,220
|
|
|
|
5,785,878
|
|
|
|
21,986,043
|
|
General and
administrative
|
|
|
4,840,368
|
|
|
|
5,572,397
|
|
|
|
10,071,291
|
|
|
|
10,913,594
|
|
Litigation
Settlement
|
|
|
5,000,000
|
|
|
|
—
|
|
|
|
5,000,000
|
|
|
|
—
|
|
Total operating
expenses
|
|
|
12,340,010
|
|
|
|
16,837,617
|
|
|
|
20,857,169
|
|
|
|
32,899,637
|
|
Operating
loss
|
|
|
(12,340,010)
|
|
|
|
(16,701,059)
|
|
|
|
(20,857,169)
|
|
|
|
(32,115,255)
|
|
Other income (expense),
net:
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
|
(208,683)
|
|
|
|
(227,609)
|
|
|
|
(402,034)
|
|
|
|
(242,703)
|
|
Interest income
(expense), net
|
|
|
(490,339)
|
|
|
|
(401,170)
|
|
|
|
(949,248)
|
|
|
|
(1,047,720)
|
|
Change in fair value
of derivative liability
|
|
|
—
|
|
|
|
204,000
|
|
|
|
—
|
|
|
|
198,000
|
|
Foreign currency
exchange gain (loss), net
|
|
|
(209,856)
|
|
|
|
(12,538)
|
|
|
|
(477,679)
|
|
|
|
4,134
|
|
Other income
(expense), net
|
|
|
(908,878)
|
|
|
|
(437,317)
|
|
|
|
(1,828,961)
|
|
|
|
(1,088,289)
|
|
Net loss
|
|
$
|
(13,248,888)
|
|
|
$
|
(17,138,376)
|
|
|
$
|
(22,686,130)
|
|
|
$
|
(33,203,544)
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.11)
|
|
|
$
|
(0.15)
|
|
|
$
|
(0.18)
|
|
|
$
|
(0.28)
|
|
Weighted average number
of common shares outstanding, basic and diluted
|
|
|
125,255,881
|
|
|
|
116,364,131
|
|
|
|
125,249,596
|
|
|
|
120,722,622
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(13,248,888)
|
|
|
$
|
(17,138,376)
|
|
|
$
|
(22,686,130)
|
|
|
$
|
(33,203,544)
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized
gain (loss) on marketable debt securities
|
|
|
50,373
|
|
|
|
23,311
|
|
|
|
(56,875)
|
|
|
|
(5,454)
|
|
Total other
comprehensive income (loss)
|
|
|
50,373
|
|
|
|
23,311
|
|
|
|
(56,875)
|
|
|
|
(5,454)
|
|
Total comprehensive
loss
|
|
$
|
(13,198,515)
|
|
|
$
|
(17,115,065)
|
|
|
$
|
(22,743,005)
|
|
|
$
|
(33,208,998)
|
|
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SOURCE Corbus Pharmaceuticals