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 announced its financial results for the third quarter ended
September 30, 2019. The Company also provided an update on its
corporate progress, clinical status and financial position.
“We remain on schedule for topline data from our
RESOLVE-1 study for the treatment of systemic sclerosis and Phase
2b study in cystic fibrosis next summer. In addition, we anticipate
that our CB1 inverse agonist, CRB-4001, targeting liver
inflammation and fibrosis will read out Phase 1 safety data in
2020. We are developing strategic partnerships to expand potential
lenabasum commercialization beyond the U.S. and Japan, with other
countries in Asia as the primary focus. Lastly, we are making
steady progress on preclinical programs to expand our pipeline and
plan to eventually partner some of them,” commented Yuval Cohen,
Ph.D., Chief Executive Officer of Corbus.
Corporate Highlights:
- Systemic Sclerosis
(SSc) – Phase 3 “RESOLVE-1” study topline results
on track for readout in summer of 2020, with potential approval in
2021. Oral and poster presentations of latest open-label
extension data from ongoing Phase 2 study (21 months) will be
presented at the American College of Rheumatology (ACR) 2019 Annual
Meeting being held November 8-13 in Atlanta, GA. Baseline subject
demographics and disease characteristics for “RESOLVE-1” Phase 3
study will also be presented.
- Cystic Fibrosis (CF) –
Phase 2b study topline results, utilizing pulmonary exacerbations
as a primary endpoint, on track for readout in summer of
2020. Patient screening complete; enrollment of Phase 2b
study expected to complete within next few weeks. Study has been
funded in part by a Development Award for up to $25 million from
the Cystic Fibrosis Foundation. Despite important advances in the
treatment of CF including CFTR-targeting medications, people with
CF continue to face significant risk and treatment burden from
pulmonary exacerbations.
- Dermatomyositis (DM) –
Phase 3 “DETERMINE” study enrollment ongoing, with topline data of
lenabasum expected in 2021. Oral
presentation of 68-week safety and efficacy data from Phase 2
open-label extension study will be given at the ACR 2019 Annual
Meeting.
- Systemic Lupus Erythematosus (SLE) – Phase 2 study
ongoing with topline data of lenabasum expected in 2020.
Phase 2 study is funded and managed by the National Institutes of
Health (NIH). SLE represents the largest indication currently
explored in the clinic with lenabasum with approximately 550,000
patients in the U.S., EU, and Japan.
- CRB-4001 – First-in-human
clinical study is scheduled for 2020. Novel inverse
agonist of cannabinoid receptor type 1 (CB1) designed to avoid the
psychiatric side effects of rimonabant that were due to that drug’s
interaction with CB1 in the brain. Clinical development will target
NAFLD/NASH.
- Early-stage, novel drug
compounds targeting the endocannabinoid system will fuel expansion
of the Company’s clinical pipeline. Corbus recently
introduced a group of early-stage CB2 agonists and CB1 inverse
agonists with positive activity in assays of inflammation and
fibrosis. Company will explore partnerships for development of
certain early-stage compounds.
- Groundwork for
commercialization has commenced. Craig Millian, our Chief
Commercial Officer, and his team have been conducting market
research and preparing for a potential approval of lenabasum in
2021. We will be sharing first details of this on the call
today.
For more information on Corbus’ clinical programs, please visit
the Company’s website at www.corbuspharma.com.
Lenabasum is not approved for the treatment of
systemic sclerosis, dermatomyositis, cystic fibrosis or systemic
lupus erythematosus. CRB-4001 is not approved for the treatment of
NASH/NAFLD.
Summary of Financial Results for Third Quarter 2019
Ended September 30, 2019
For the quarter ended September 30, 2019, the
Company reported a net loss of approximately $20,791,000 or a net
loss per diluted share of $0.32, compared to a net loss of
approximately $14,601,000, or a net loss per diluted share of
$0.26, for the quarter ended September 30, 2018.
For the nine months ended September 30, 2019,
the Company reported a net loss of approximately $44,873,000, or a
net loss per diluted share of $0.71, compared to a net loss of
approximately $38,366,000, or a net loss per diluted share of
$0.67, for the nine months ended September 30, 2018.
For the quarter ended September 30, 2019,
revenue from awards increased by approximately $1.5 million to $2.6
million due to revenue recognized from the Development Award
Agreement with the Cystic Fibrosis Foundation.
Operating expenses for the quarter ended
September 30, 2019 increased by approximately $11.7 million to
$27.7 million. The increase was attributable to increased spending
for clinical studies, the costs to manufacture and supply lenabasum
for clinical trials, staffing costs, and non-cash stock
compensation expense.
The Company ended the quarter with $54.8 million
in cash and cash equivalents. The Company expects the current cash
and cash equivalents together with the $7.5 million remainder of
the expected milestone payments from the up to $25 million
Development Award from the Cystic Fibrosis Foundation to fund
operations into the third quarter of 2020, through topline data
readouts in systemic sclerosis and cystic fibrosis, based on
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, Thursday, November 7 at 8:30 a.m. ET.
To participate in 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 Phase
3 clinical-stage pharmaceutical company focused on the development
and commercialization of novel therapeutics to treat inflammatory
and fibrotic diseases by leveraging its pipeline of rationally
designed, endocannabinoid system-targeting drug candidates. The
Company's lead product candidate, lenabasum, is a novel, oral,
selective cannabinoid receptor type 2 (CB2) agonist rationally
designed to resolve chronic inflammation and fibrotic processes.
Lenabasum is currently being evaluated in systemic sclerosis,
cystic fibrosis, dermatomyositis and systemic lupus
erythematosus.
Corbus is also developing a pipeline of drug
candidates targeting the endocannabinoid system. The pipeline
includes CRB-4001, a 2nd generation, selective cannabinoid receptor
type 1 (CB1) inverse agonist designed to be peripherally
restricted. Potential indications for CRB-4001 include nonalcoholic
steatohepatitis (NASH), among others. Corbus expects data from its
Phase 1 safety study in 2020.
For more information, please visit
www.CorbusPharma.com and connect with the Company 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 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 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 30,2019 |
|
|
December 31,2018 |
|
|
|
(unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
54,849,365 |
|
|
$ |
41,748,468 |
|
Prepaid expenses and other current assets |
|
|
2,685,923 |
|
|
|
2,491,844 |
|
Total current assets |
|
|
57,535,288 |
|
|
|
44,240,312 |
|
Property and equipment,
net |
|
|
4,891,063 |
|
|
|
2,705,206 |
|
Operating lease right of use
assets |
|
|
5,569,999 |
|
|
|
— |
|
Other assets |
|
|
134,034 |
|
|
|
43,823 |
|
Total assets |
|
$ |
68,130,384 |
|
|
$ |
46,989,341 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Notes payable |
|
$ |
— |
|
|
$ |
394,305 |
|
Accounts payable |
|
|
6,193,507 |
|
|
|
6,345,335 |
|
Accrued expenses |
|
|
23,969,303 |
|
|
|
9,851,191 |
|
Deferred revenue |
|
|
— |
|
|
|
1,462,503 |
|
Operating lease liabilities, current |
|
|
386,618 |
|
|
|
— |
|
Deferred rent, current |
|
|
— |
|
|
|
35,996 |
|
Total current liabilities |
|
|
30,549,428 |
|
|
|
18,089,330 |
|
Operating lease liabilities,
noncurrent |
|
|
7,940,283 |
|
|
|
— |
|
Deferred rent, noncurrent |
|
|
— |
|
|
|
1,375,891 |
|
Total liabilities |
|
|
38,489,711 |
|
|
|
19,465,221 |
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Preferred Stock $0.0001 par value:10,000,000 shares authorized, no
shares issued and outstanding at September 30, 2019 and December
31, 2018 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 150,000,000 shares authorized,
64,672,893 and 57,247,496 shares issued and outstanding at
September 30, 2019 and December 31, 2018 |
|
|
6,467 |
|
|
|
5,725 |
|
Additional paid-in capital |
|
|
195,877,403 |
|
|
|
148,888,635 |
|
Accumulated deficit |
|
|
(166,243,197 |
) |
|
|
(121,370,240 |
) |
Total stockholders’ equity |
|
|
29,640,673 |
|
|
|
27,524,120 |
|
Total liabilities and stockholders’ equity |
|
$ |
68,130,384 |
|
|
$ |
46,989,341 |
|
Corbus Pharmaceuticals
Holdings, Inc.Condensed Consolidated Statements of
Operations(Unaudited)
|
|
For the Three Months Ended |
|
|
For the Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenue from awards
and licenses |
|
$ |
2,589,783 |
|
|
$ |
1,090,878 |
|
|
$ |
33,570,048 |
|
|
$ |
2,894,966 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
22,152,001 |
|
|
|
12,807,800 |
|
|
|
66,117,114 |
|
|
|
32,833,029 |
|
General and administrative |
|
|
5,534,493 |
|
|
|
3,181,071 |
|
|
|
17,367,202 |
|
|
|
9,218,652 |
|
Total operating expenses |
|
|
27,686,494 |
|
|
|
15,988,871 |
|
|
|
83,484,316 |
|
|
|
42,051,681 |
|
Operating loss |
|
|
(25,096,711 |
) |
|
|
(14,897,993 |
) |
|
|
(49,914,268 |
) |
|
|
(39,156,715 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income |
|
|
4,109,338 |
|
|
|
- |
|
|
|
4,109,338 |
|
|
|
- |
|
Interest income, net |
|
|
292,854 |
|
|
|
268,335 |
|
|
|
1,076,166 |
|
|
|
738,052 |
|
Foreign currency exchange gain (loss), net |
|
|
(96,282 |
) |
|
|
28,447 |
|
|
|
(144,193 |
) |
|
|
52,716 |
|
Other income, net |
|
|
4,305,910 |
|
|
|
296,782 |
|
|
|
5,041,311 |
|
|
|
790,768 |
|
Net loss |
|
$ |
(20,790,801 |
) |
|
$ |
(14,601,211 |
) |
|
$ |
(44,872,957 |
) |
|
$ |
(38,365,947 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.32 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.71 |
) |
|
$ |
(0.67 |
) |
Weighted average number of
common shares outstanding, basic and diluted |
|
|
64,660,017 |
|
|
|
57,218,832 |
|
|
|
63,638,447 |
|
|
|
56,917,897 |
|
Corbus Pharmaceuticals
Contacts:
Ted Jenkins, Senior Director, Investor Relations and Corporate
CommunicationsPhone: +1 (617) 415-7745Email:
ir@corbuspharma.com
Lindsey Smith, Associate Director, Investor Relations and
Corporate CommunicationsPhone: +1 (617) 415-7749Email:
mediainfo@corbuspharma.com
Jenene ThomasJenene Thomas Communications, LLCPhone: +1 (833)
475-8247Email: crbp@jtcir.com
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