Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP)
(“Corbus” or the “Company”) today announced its financial results
for the first quarter ended March 31, 2019. The Company also
provided an update on its corporate progress, clinical status and
financial position.
Key Achievements in Q1
2019:
- Announced the change of primary
endpoint in ongoing RESOLVE-1 Phase 3 study in systemic sclerosis
in U.S. to ACR CRISS following meeting with U.S. FDA;
- Completed subject enrollment in
RESOLVE-1 Phase 3 study of lenabasum treatment for systemic
sclerosis, Company expects to report topline results from this
study in the summer of 2020;
- Completed licensing deal for
lenabasum in Japan with Kaken Pharmaceuticals. Received $27M
up-front payment, with up to $173M in potential milestones as well
as double-digit royalties;
- Raised $40M in equity capital from
a public offering lead by Jefferies and RBC;
- Cash balance increased by $48.2M
from year-end to $89.9M at March 31, 2019;
- Appointed Rachelle Jacques to Board
of Directors, who brings U.S. and global commercialization and
marketing experience, including multiple product launches in rare
diseases; and
- Appointed Craig Millian as Chief
Commercial Officer to lead global marketing and commercialization
strategies.
“We made significant progress during the quarter
in our clinical programs and have begun laying the foundation for
the commercialization of lenabasum,” commented Yuval Cohen, Ph.D.,
Chief Executive Officer of Corbus. “We continue to advance
lenabasum through the clinic and remain on track with our four
ongoing clinical studies. We expect to launch a Phase 1 study of
CRB-4001 later this year. We are working to identify additional
drug candidates from our unique portfolio of pre-clinical compounds
that target the endocannabinoid system. Looking ahead, we are
confident that our clinical progress and corporate
commercialization strategy, supported by our strong balance sheet,
will position Corbus to unlock significant value for all
stakeholders.”
Lenabasum – Novel, oral, selective cannabinoid receptor
type 2 (CB2) agonist designed to resolve chronic inflammation and
fibrotic processes
Systemic Sclerosis (SSc) – Phase 3 “RESOLVE-1”
Study Enrolled with Topline Results Expected in summer of 2020
- SSc is a chronic, rare systemic
autoimmune disease characterized by inflammation and fibrosis
affecting ~200,000 people in the U.S., EU and Japan;
- SSc has the highest mortality rate
among the systemic autoimmune diseases;
- Enrollment completed and dosing
ongoing in Phase 3 study, Company expects to report topline results
from this study in the summer of 2020; and
- No drugs currently approved by the
U.S. FDA for treatment of SSc. Treatment options for overall
disease control limited to immunosuppressive drugs.
Following a Type C meeting with the U.S. Food
and Drug Administration (FDA), Corbus recently announced that it
will change the primary efficacy endpoint of the ongoing RESOLVE-1
Phase 3 SSc trial in the U.S. to the American College of
Rheumatology Combined Response Index in diffuse cutaneous Systemic
Sclerosis (ACR CRISS) score at Week 52 from the current primary
endpoint, change in modified Rodnan Skin core (mRSS). The ACR CRISS
score was the primary efficacy endpoint of the Phase 2 study
evaluating lenabasum for the treatment of diffuse cutaneous SSc.
The Company remains on track to complete the RESOLVE-1 study in the
summer of 2020 and no changes to the size or length of the study
are required. Corbus remains blinded to the treatment assignment of
subjects until after database lock occurs in the second quarter of
2020.
Corbus expects to report topline results from
the Phase 3 RESOLVE-1 study in the summer of 2020, with
commercialization in late 2021 following potential U.S. FDA
approval. Lenabasum was granted Orphan Drug Designation for the
treatment of SSc from the U.S. FDA and the European Medicines
Agency (EMA) and granted Fast Track status from the FDA. For more
information on the Phase 3 study, please
visit ClinicalTrials.gov and reference Identifier
NCT03398837.
Dermatomyositis (DM) – 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%;
- Enrollment is ongoing in the Phase
3 study with the American College of Rheumatology/European League
Against Rheumatism 2016 Total Improvement Score in myositis as the
primary efficacy endpoint.
Lenabasum was granted Orphan Drug Designation
for the treatment of DM from the U.S. FDA and EMA. For more
information on the Phase 3 study, please
visit ClinicalTrials.gov and reference Identifier
NCT03813160.
Cystic Fibrosis (CF) – Phase 2b Study Underway,
Study Funded in Part by a Development Award for up to $25 Million
from the Cystic Fibrosis Foundation
- CF is a life-threatening genetic
disease characterized in part by chronic lung inflammation that
leads to lung damage and fibrosis. CF affects ~70,000 people in
U.S. and EU;
- Enrollment and dosing are ongoing
in the Phase 2b study with event rate of pulmonary exacerbations
(PEx) as the primary efficacy endpoint. Pulmonary exacerbations are
a clinically relevant event of increase in respiratory symptoms
usually accompanied by an acute decrease in lung function and an
increase in lung inflammation;
- Pulmonary exacerbations are
responsible for about half of long-term decline in lung function
experienced by people with CF; and
- There continues to be an unmet need
for drugs that reduce rate and severity of PEx in people with
CF.
Corbus expects to report topline results for the
large Phase 2b CF study in 2020. Lenabasum was granted Orphan Drug
Designation for the treatment of CF from the U.S. FDA and the EMA
and granted Fast Track status from the FDA. For more information on
the Phase 2b study, please visit ClinicalTrials.gov and
reference Identifier NCT03451045.
Systemic Lupus Erythematosus (SLE) – Phase 2
Study Underway, Represents the Largest Potential Patient Population
Targeted by Lenabasum
- Systemic lupus erythematosus is a
severe and sometimes life-threatening systemic autoimmune disease
affecting approximately 550,000 people in the U.S., EU and
Japan;
- Disease pathology can include
inflammation in many different organs, including the kidneys and
brain;
- Enrollment and dosing are ongoing
in a first-in-patient Phase 2 study being conducted and funded by
the National Institutes of Health (NIH); and
- People with SLE continue to have
high unmet medical need as standard-of-care often includes
immunosuppressive drugs, which can have 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 - 2nd Generation,
Peripherally-restricted, Selective Cannabinoid Receptor Type 1
(CB1) Inverse Agonist Targeting Liver Fibrosis
CRB-4001 is rationally designed to be an inverse
agonist of cannabinoid receptor type 1. It has been designed to
improve certain metabolic abnormalities in people with nonalcoholic
steatohepatitis (NASH) or non-alcoholic fatty liver disease
(NAFLD), while reducing inflammation and fibrosis in the liver.
Preparations are underway to begin a Phase 1 study of CRB-4001 by
the end of 2019 followed by a planned Phase 2 study of effects of
CRB-4001 in people with metabolic syndrome or NASH, which is
expected to be conducted by the NIH.
CRB-4001 is not approved for the treatment of NASH.
Summary of Financial Results for First Quarter 2019
Ended March 31, 2019
For the quarter ended March 31, 2019, the
Company reported a net loss of approximately $26,235,000 or a net
loss per diluted share of $0.43, compared to a net loss of
approximately $11,695,000, or a net loss per diluted share of
$0.21, for the quarter ended March 31, 2018. For the quarter ended
March 31, 2019, revenue from awards increased by approximately $0.9
million to $1.9 million due to revenue recognized from the
Development Award Agreement with the Cystic Fibrosis
Foundation.
Operating expenses for the quarter ended March
31, 2019 increased by approximately $15.6 million to $28.4 million.
The increase was attributable to increased spending for clinical
studies, cost to manufacture and supply Lenabasum for clinical
trials, staffing costs, a $1.2 million increase in non-cash stock
compensation expenses and a $2.7 million sub-royalty payment
accrued as of March 31, 2019 due to the CF Foundation as a result
of the $27 million up-front licensing payment received from Kaken
Pharmaceuticals.
The Company's cash and cash equivalents balance
increased by $48.2 million from December 31, 2018 to $89.9 million
at March 31, 2019. In January 2019 the Company completed a public
offering of common stock which raised $40 million in gross proceeds
and in March 2019 the Company received a $27 million up-front
payment from the licensing deal with Kaken Pharmaceuticals. The
Company expects the current cash and cash equivalents together with
the remainder of the expected milestone payments from the up to $25
million Development Award from the Cystic Fibrosis Foundation 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, Thursday, May 9 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
treatment was associated with improvement in multiple
physician-assessed and patient-reported efficacy outcomes in Phase
2 studies in patients with diffuse cutaneous SSc and
skin-predominant dermatomyositis. ACR CRISS score was the primary
efficacy endpoint in the Phase 2 study of lenabasum in diffuse
cutaneous SSc and showed a greater treatment effect in subjects who
received lenabasum compared to placebo in that study. Lenabasum
treatment also was associated with a lower rate of and longer time
to 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, intended to be followed by an NIH-funded first-in-patient
Phase 2 study.
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 endocannabinoid
system-targeting synthetic 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. Potential indications for CRB-4001
include NASH, among others. Corbus plans to start a Phase 1 study
of CRB-4001 in 2019, intended to be followed by a National
Institutes of Health (NIH)-funded proof-of-concept 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
|
|
March 31, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
(unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
89,919,798 |
|
|
$ |
4 1,748,468 |
|
Prepaid expenses and
other current assets |
|
|
2,904,215 |
|
|
|
2,491,844 |
|
Total current assets |
|
|
92,824,013 |
|
|
|
44,240,312 |
|
Property and equipment,
net |
|
|
2,694,489 |
|
|
|
2,705,206 |
|
Operating lease right of use
assets |
|
|
5,839,435 |
|
|
|
— |
|
Other assets |
|
|
35,589 |
|
|
|
43,823 |
|
Total assets |
|
$ |
101,393,526 |
|
|
$ |
4 6,989,341 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Notes
payable |
|
$ |
247,384 |
|
|
$ |
3 94,305 |
|
Accounts payable |
|
|
8,962,750 |
|
|
|
6,345,335 |
|
Accrued
expenses |
|
|
15,563,853 |
|
|
|
9,851,191 |
|
Deferred revenue, current |
|
|
27,000,000 |
|
|
|
1,462,503 |
|
Operating lease
liabilities |
|
|
266,807 |
|
|
|
35,996 |
|
Total current liabilities |
|
|
52,040,794 |
|
|
|
18,089,330 |
|
Operating lease liabilities,
noncurrent |
|
|
7,051,781 |
|
|
|
1,375,891 |
|
Total liabilities |
|
|
59,092,575 |
|
|
|
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 March 31, 2019 and December 31,
2018 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 150,000,000 shares authorized,
64,455,221 and 57,247,496 shares issued and outstanding at March
31, 2019 and December 31, 2018 |
|
|
6,446 |
|
|
|
5,725 |
|
Additional paid-in
capital |
|
|
189,899,554 |
|
|
|
148,888,635 |
|
Accumulated deficit |
|
|
(147,605,049 |
) |
|
|
(121,370,240 |
) |
Total stockholders’
equity |
|
|
42,300,951 |
|
|
|
27,524,120 |
|
Total liabilities and stockholders’ equity |
|
$ |
101,393,526 |
|
|
$ |
46,989,341 |
|
Corbus Pharmaceuticals Holdings,
Inc.
Condensed Consolidated Statements of
Operations
|
|
For the Three Months EndedMarch
31, |
|
|
|
2019 |
|
|
2018 |
|
Revenue from awards |
|
$ |
1,885,682 |
|
|
$ |
950,442 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
|
21,783,704 |
|
|
|
9,765,362 |
|
General and
administrative |
|
|
6,624,747 |
|
|
|
3,050,032 |
|
Total operating
expenses |
|
|
28,408,451 |
|
|
|
12,815,394 |
|
Operating loss |
|
|
(26,522,769 |
) |
|
|
(11,864,952 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income,
net |
|
|
334,595 |
|
|
|
203,421 |
|
Foreign currency
exchange loss, net |
|
|
(46,635 |
) |
|
|
(33,854 |
) |
Other income, net |
|
|
287,960 |
|
|
|
169,567 |
|
Net loss |
|
$ |
(26,234,809 |
) |
|
$ |
(11,695,385 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.21 |
) |
Weighted average number of
common shares outstanding, basic and diluted |
|
|
61,675,904 |
|
|
|
56,367,548 |
|
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
Source: Corbus Pharmaceuticals Holdings, Inc.
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