Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or
the “Company”), a clinical stage drug development company with the
industry’s leading pipeline focused on treating inflammatory and
fibrotic diseases through the endocannabinoid system pathways,
announced today its financial results for the fourth quarter and
year ended December 31, 2018. The Company also provided an update
on its corporate progress, clinical status and financial position.
Recent Clinical and Corporate
Achievements:
|
● |
Entered into strategic collaboration with Kaken Pharmaceutical Co.,
Ltd. for the development and commercialization of lenabasum in
Japan. Deal included a $27 million upfront payment, up to $173
million of additional potential milestone payments and double-digit
royalties; |
|
● |
Appointed Craig Millian as Chief Commercial Officer to lead global
marketing and commercialization strategies; |
|
● |
Announced the successful closing of $40 million public offering of
common stock; |
|
● |
Strengthened lenabasum intellectual property protection through
2034 with issuance of four U.S. patents (#’s10,154,986, 10,085,964,
9,801,849 and 9,820,964) covering composition of matter and broad
use in inflammatory and fibrotic diseases; |
|
● |
Initiated Phase 3 lenabasum study in dermatomyositis (DM), titled
“DETERMINE”; and |
|
● |
Presented ongoing Phase 2 lenabasum open label extension (OLE) data
for both Systemic Sclerosis and Dermatomyositis at the 2018
American College of Rheumatology (ACR) Annual Meeting and the 2018
Annual European Congress of Rheumatology Meeting (EULAR). |
“2018 was a year of significant progress for
Corbus. We made meaningful advancements in the clinical development
of lenabasum, and we also completed two transformational commercial
transactions, which expanded our clinical pipeline and broadened
our global commercial opportunity. We believe the acquisition of
more than 600 ECS-targeting drug candidates will fuel sustained
growth of our platform and cement our leadership position in the
field. The most advanced candidate, CRB-4001, is expected to enter
Phase 1 clinical study later this year and to be followed by a
Phase 2 study in patients with NASH. Our strategic collaboration
with Kaken Pharmaceutical in Japan is our first step towards
commercializing lenabasum in key markets outside of the United
States,” commented Yuval Cohen, Ph.D., Chief Executive Officer of
Corbus.
Dr. Cohen continued, “Looking ahead, we are focused on
positioning the Company for a successful commercial launch of
lenabasum, following potential U.S. FDA approval in 2021. We are
excited for the opportunities ahead and look forward to continuing
to develop meaningful solutions for patients, while driving value
for our shareholders.”
Lenabasum – Novel, synthetic, oral,
selective cannabinoid receptor type 2 (CB2) agonist designed to
resolve chronic inflammation and fibrotic processes
Systemic Sclerosis – Late-Stage Clinical Program
with Potential Commercialization in 2021
|
● |
Systemic Sclerosis is a rare and life-threatening autoimmune
disease characterized by inflammation and fibrosis affecting
~200,000 people in the U.S., Europe and Japan; |
|
● |
Approximately 40% to 60% 10-year mortality; |
|
● |
18-month OLE data presented at ACR demonstrated an acceptable
safety profile and further improvement in efficacy outcomes. The
modified Rodnan Skin Score (mRSS) improved by a mean of -10.7
points in the OLE. The ACR CRISS score steadily improved and
reached a median score of 99% with 50% of the subjects achieving an
ACR CRISS of 100%; |
|
● |
Enrollment and dosing are ongoing in the Phase 3 international
RESOLVE-1 study; and |
|
● |
No
drugs currently approved by the FDA for treatment of SSc. Treatment
options for overall disease control limited to immunosuppressive
drugs. |
Corbus expects to report topline results from
the Phase 3 RESOLVE-1 study in 2020. For more information on the
Phase 3 study, please visit ClinicalTrials.gov and reference
Identifier NCT03398837.
Dermatomyositis – Phase 3
“DETERMINE” Study Underway
|
● |
DM is
a rare and serious autoimmune condition characterized by skin and
muscle inflammation affecting ~80,000 people in the U.S., EU and
Japan; |
|
● |
5-year mortality as high as 30%; |
|
● |
12-month OLE data presented at ACR demonstrated an acceptable
safety profile and further improvement in efficacy outcomes. The
CDASI activity score improved by a -17.6 points in the OLE, with an
improvement of -4 to -5 points being considered medically
important; |
|
● |
Commenced Phase 3 study titled
“DETERMINE” in December 2018;
and |
|
● |
Lenabasum granted Orphan Drug Designation in the U.S and in
Europe. |
For more information on the Phase 3 study,
please visit ClinicalTrials.gov and reference Identifier
NCT03813160.
Cystic Fibrosis–Phase 2b Study Funded by a Development Award for
up to $25 Million from the Cystic Fibrosis Foundation
|
● |
Cystic Fibrosis is a life-threatening genetic disease characterized
by chronic lung inflammation that leads to lung damage and
fibrosis; |
|
● |
Affects ~70,000 people in 7 major markets; |
|
● |
Current average life expectancy for CF patients is approximately 40
years; |
|
● |
Enrollment and dosing are ongoing in the Phase 2b study with
Pulmonary Exacerbations as the primary efficacy endpoint; and |
|
● |
Continued unmet need for drugs to treat pulmonary exacerbations,
which are acute episodes of lung inflammation which cause
significant decline in respiratory function, high medical costs,
and frequently irreversible lung damage. |
Corbus expects to report topline results for the
Phase 2b CF study in 2020. For more information on the Phase 2b
study, please visit ClinicalTrials.gov and reference Identifier
NCT03451045.
Systemic Lupus Erythematosus (SLE) – Represents
the Largest Patient Population Targeted by Lenabasum
|
● |
Enrollment and dosing are ongoing in a first-in-patient Phase 2
study being conducted and funded by the National Institute of
Health; |
|
● |
Prototypical multisystem autoimmune disease in which the innate
immune system is chronically activated leading to tissue
inflammation and damage; |
|
● |
Affects ~300,000 people in U.S. with a 2.4-fold increase in
mortality; and |
|
● |
Patients with SLE continue to have high unmet medical need as
current treatments are generally immunosuppressive agents, which
can lead to significant side effects. |
For more information on the Phase 2 study of
lenabasum for the treatment of SLE, please visit ClinicalTrials.gov
and reference Identifier NCT03093402.
Lenabasum is not approved for the treatment of
systemic sclerosis, dermatomyositis, cystic fibrosis or systemic
lupus erythematosus.
CRB-4001 - Peripheral CB1 Inverse
Agonist Targeting Liver Fibrosis
CRB-4001 is rationally designed to have a potent
effect on deactivating CB1 to reduce inflammation and fibrosis in
target organs such as the liver or kidneys while avoiding
blood-brain barrier penetration to limit impact on CB1 brain
receptors, thus mediating the neuropsychiatric issues associated
with first-generation CB1 inverse agonists or antagonists.
Preparations are underway to commence a Phase 1 study of CRB-4001
followed by a planned Phase 2 NASH study expected to be conducted
by the NIH. Potential indications for CRB-4001 include NASH,
primary biliary cholangitis, idiopathic pulmonary fibrosis,
radiation-induced pulmonary fibrosis, myocardial fibrosis after
myocardial infarction, and acute interstitial nephritis, among
others.
CRB-4001 is not approved for the treatment of NASH.
Summary of Financial Results for Fourth
Quarter and Year Ended December 31, 2018
For the quarter ended December 31, 2018, the
Company reported a net loss of approximately $17,306,000 or a net
loss per diluted share of $0.30, compared to a net loss of
approximately $10,694,000, or a net loss per diluted share of
$0.20, for the quarter ended December 31, 2017.
For the year ended December 31, 2018, the
Company reported a net loss of approximately $55,672,000 or a net
loss per diluted share of $0.98, compared to a net loss of
approximately $32,422,000, or a net loss per diluted share of
$0.65, for the year ended December 31, 2017.
For the year ended December 31, 2018, revenue
from awards increased by approximately $2.4 million to $4.8 million
due to revenue recognized from the up to $25 million Development
Award Agreement with the Cystic Fibrosis Foundation. Operating
expenses increased by approximately $26.6 million to $61.6 million
due to increased spending for clinical studies, manufacturing costs
to produce lenabasum for clinical studies and staffing costs. For
the quarter ended December 31, 2018, revenue from awards increased
by approximately $1.9 million and operating expenses increased by
approximately $8.7 million.
The Company’s cash and cash equivalents balance
at December 31, 2018 was approximately $41.7 million. In January
2019, the Company completed a $40 million public offering before
deducting underwriting discounts and offering expenses and the
Company will receive a $27 million up-from payment from the Kaken
licensing deal. The Company expects the current cash and cash
equivalents to fund operations into the fourth quarter of 2020,
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, Tuesday, March 12 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 Lenabasum
Lenabasum is a rationally-designed, oral, small
molecule that selectively binds as an agonist to the cannabinoid
receptor type 2 (CB2). CB2 is preferentially expressed on activated
immune cells, fibroblasts, muscle cells, and endothelial cells. In
both animal and human studies conducted to-date, lenabasum has
induced the production of Specialized Pro-resolving lipid Mediators
(“SPMs”) that activate endogenous pathways which resolve
inflammation and speed bacterial clearance without
immunosuppression. Lenabasum is also believed to have a direct
effect on fibroblasts to limit production of fibrogenic growth
factors and extracellular connective tissue that lead to tissue
fibrosis (scarring). Data from animal models and human clinical
studies suggest that lenabasum can reduce expression of genes and
proteins involved in inflammation and fibrosis. Lenabasum has
demonstrated promising activity in animal models of skin and lung
inflammation and fibrosis in systemic sclerosis (SSc). Lenabasum is
also active in animal models of lung infection and inflammation in
cystic fibrosis and joint inflammation and scarring in rheumatoid
arthritis.
Lenabasum has demonstrated an acceptable safety
and tolerability profiles in clinical studies to date. Lenabasum
improved multiple physician-assessed and patient-reported efficacy
outcomes in Phase 2 studies in patients with diffuse cutaneous SSc
and skin-predominant dermatomyositis. Lenabasum also reduced
pulmonary exacerbations in a Phase 2 cystic fibrosis study.
Additional clinical studies are being conducted and/or planned to
confirm these results and support applications for regulatory
approval.
About CRB-4001
CRB-4001 is a 2nd generation,
peripherally-restricted, CB1 inverse agonist. CRB-4001 was
developed in collaboration with and financial support from the
National Institutes of Health (NIH). CRB-4001 was specifically
designed to eliminate blood-brain barrier penetration and brain CB1
receptor occupancy that mediate the neuropsychiatric issues
associated with first-generation CB1 inverse agonists such as
rimonabant. Corbus expects to initiate a Phase 1 study for CRB-4001
in 2019, followed by an NIH-funded first-in-patient Phase 2
study.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:
CRBP) 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 industry
leading pipeline of endocannabinoid system-targeting drug
candidates. The Company’s lead product candidate, lenabasum, is a
novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2)
agonist 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 from more than 600 novel compounds targeting the
endocannabinoid system. The pipeline includes CRB-4001, a 2nd
generation, peripherally-restricted, selective cannabinoid receptor
type 1 (CB1) inverse agonist specifically designed to eliminate
blood-brain barrier penetration and brain CB1 receptor occupancy
that mediate the neuropsychiatric issues associated with
first-generation CB1 inverse agonists. Potential indications for
CRB-4001 include NASH, primary biliary cholangitis, idiopathic
pulmonary fibrosis, radiation-induced pulmonary fibrosis,
myocardial fibrosis after myocardial infarction and acute
interstitial nephritis, among others. CRB-4001 is scheduled to
enter a Phase 1 study in 2019 followed by a National Institutes of
Health (NIH)-funded first-in-patient Phase 2 study.
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
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
41,748,468 |
|
|
$ |
62,537,495 |
|
Restricted cash |
|
|
— |
|
|
|
158,991 |
|
Prepaid
expenses and other current assets |
|
|
2,491,844 |
|
|
|
2,808,244 |
|
Total
current assets |
|
|
44,240,312 |
|
|
|
65,504,730 |
|
Property and equipment,
net |
|
|
2,705,206 |
|
|
|
1,432,655 |
|
Other assets |
|
|
43,823 |
|
|
|
40,776 |
|
Total
assets |
|
$ |
46,989,341 |
|
|
$ |
66,978,161 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Notes
payable |
|
$ |
394,305 |
|
|
$ |
332,861 |
|
Accounts
payable |
|
|
6,345,335 |
|
|
|
3,130,295 |
|
Accrued
expenses |
|
|
9,851,191 |
|
|
|
4,741,519 |
|
Deferred
revenue, current |
|
|
1,462,503 |
|
|
|
— |
|
Deferred
rent, current |
|
|
35,996 |
|
|
|
— |
|
Total
current liabilities |
|
|
18,089,330 |
|
|
|
8,204,675 |
|
Deferred rent,
noncurrent |
|
|
1,375,891 |
|
|
|
989,550 |
|
Other liabilities |
|
|
— |
|
|
|
375 |
|
Total
liabilities |
|
|
19,465,221 |
|
|
|
9,194,600 |
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
|
Preferred
Stock $0.0001 par value:10,000,000 shares authorized, no shares
issued and outstanding at December 31, 2018 and December 31,
2017 |
|
|
— |
|
|
|
— |
|
Common
stock, $0.0001 par value; 150,000,000 shares authorized, 57,247,496
and 55,603,427 shares issued and outstanding at December 31, 2018
and December 31, 2017, respectively |
|
|
5,725 |
|
|
|
5,560 |
|
Additional paid-in capital |
|
|
148,888,635 |
|
|
|
123,476,102 |
|
Accumulated deficit |
|
|
(121,370,240 |
) |
|
|
(65,698,101 |
) |
Total
stockholders’ equity |
|
|
27,524,120 |
|
|
|
57,783,561 |
|
Total
liabilities and stockholders’ equity |
|
$ |
46,989,341 |
|
|
$ |
66,978,161 |
|
Corbus Pharmaceuticals Holdings, Inc.Consolidated Statements of Operations
|
|
For the Three Months Ended |
|
|
For the Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Revenue from
awards |
|
$ |
1,927,306 |
|
|
$ |
— |
|
|
$ |
4,822,272 |
|
|
$ |
2,440,195 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
15,780,928 |
|
|
|
8,286,682 |
|
|
|
48,613,957 |
|
|
|
26,038,965 |
|
General
and administrative |
|
|
3,737,370 |
|
|
|
2,575,244 |
|
|
|
12,956,022 |
|
|
|
8,964,046 |
|
Total
operating expenses |
|
|
19,518,298 |
|
|
|
10,861,926 |
|
|
|
61,569,979 |
|
|
|
35,003,011 |
|
Operating loss |
|
|
(17,590,992 |
) |
|
|
(10,861,926 |
) |
|
|
(56,747,707 |
) |
|
|
(32,562,816 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income, net |
|
|
244,725 |
|
|
|
133,073 |
|
|
|
982,777 |
|
|
|
183,112 |
|
Foreign
currency exchange gain (loss) |
|
|
40,075 |
|
|
|
35,163 |
|
|
|
92,791 |
|
|
|
(41,908 |
) |
Other
income, net |
|
|
284,800 |
|
|
|
168,236 |
|
|
|
1,075,568 |
|
|
|
141,204 |
|
Net loss |
|
$ |
(17,306,192 |
) |
|
$ |
(10,693,690 |
) |
|
$ |
(55,672,139 |
) |
|
$ |
(32,421,612 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.30 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.98 |
) |
|
$ |
(0.65 |
) |
Weighted average number
of common shares outstanding, basic and diluted |
|
|
57,242,604 |
|
|
|
53,828,680 |
|
|
|
56,999,741 |
|
|
|
50,176,953 |
|
Investor Contacts:
Institutional Investor
InquiriesTed Jenkins, Senior Director, Investor Relations
and CommunicationsCorbus Pharmaceuticals, Inc.Phone: +1 (617)
415-7745Email: ir@corbuspharma.com
All Other Investor
InquiriesJenene ThomasJenene Thomas Communications,
LLCPhone: +1 (833) 475-8247Email: crbp@jtcir.com
Media ContactLindsey Smith,
Associate Director, Investor Relations and Corporate
CommunicationsPhone: +1 (617) 415-7749Email:
mediainfo@corbuspharma.com
Source: Corbus Pharmaceuticals Holdings,
Inc.
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