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 second
quarter ended June 30, 2019. The Company also provided an update on
its corporate progress, clinical status and financial position.
Q2 2019 Corporate
Highlights:
- Lenabasum:
- Completed subject enrollment in
RESOLVE-1 Phase 3 study of lenabasum for the treatment for systemic
sclerosis. Company expects to report topline results from this
study in the summer of 2020.
- Presented continued favorable
safety and improvement in efficacy outcomes at 21 months for
systemic sclerosis (SSc) and 16 months for dermatomyositis (DM) in
open-label extensions of lenabasum Phase 2 studies. These data were
presented at the annual European Congress of Rheumatology (EULAR
2019) conference.
- Pipeline:
- Hosted an R&D Day to highlight
the Company’s pipeline of drugs that target the endocannabinoid
system (ECS). Presentations at R&D Day showcased lenabasum’s
late-stage clinical progress, introduced CRB-4001 for NASH and
unveiled the first group of active preclinical compounds generated
from Corbus’ proprietary platform of endocannabinoid mimetics.
- Leadership:
- Appointed Rachelle Jacques as a
member of the Board of Directors. Ms. Jacques is CEO of Enzyvant
Therapeutics, Inc. and the former Global Complement Franchise Head
at Alexion Pharmaceuticals, Inc. She brings U.S. and global
commercialization and marketing experience, including multiple
product launches in rare diseases.
- Appointed Robert Discordia, Ph.D.,
as Chief Operating Officer. Dr. Discordia joined the Company in May
2018, bringing >25 years of biopharmaceutical industry
experience in CMC development and business operations to Corbus,
most recently at Bristol-Myers Squibb. In his new role, Dr.
Discordia will be responsible for optimizing the Company’s
operational efficiency and effectiveness, corporate planning and
performance management.
“Corbus made significant progress during the
second quarter as we continued to pioneer transformative medicines
that target the endocannabinoid system. We advanced our four
ongoing clinical studies for lenabasum and expect to report topline
data beginning in the summer of 2020 in systemic sclerosis and
cystic fibrosis. Additionally, we continue to execute on our
development of CRB-4001 and expect to enter the clinic with a Phase
1 study later this year,” commented Yuval Cohen, Ph.D., Chief
Executive Officer of Corbus. “In addition to our lead assets,
our team is leveraging our unique platform to generate new
endocannabinoid mimetic drugs to fuel the future growth of our
pipeline and open the door to potential collaborations. We were
pleased to present the first group of these potential compounds at
our recent R&D Day in June. With a number of important catalyst
achievements ahead, Corbus is well positioned to complete our
clinical milestones, lay the foundation for our corporate
commercialization strategy and deliver value for our
stakeholders.”
Lenabasum – Rationally-Designed, Oral,
Selective Cannabinoid Receptor Type 2 (CB2) Agonist
Systemic Sclerosis (SSc) – Phase 3 “RESOLVE-1”
Study: Enrollment Complete, Topline Data Expected in Summer of
2020
- SSc is a chronic, rare systemic
autoimmune disease characterized by tissue 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.
- Data from the Phase 2 open-label
extension was recently presented at the annual EULAR 2019
conference and showed continued favorable safety and durable
improvement in efficacy outcomes:
- ACR CRISS score remains ≥ 0.95
(95%) at 21 months in systemic sclerosis open-label extension (OLE)
study
- 81% systemic sclerosis subjects
remain on lenabasum in the OLE ≥ 21 months
- No serious or severe AEs related to
lenabasum reported in the study to date
- There are no drugs currently
approved by the U.S. Food and Drug Administration (FDA) for
treatment of SSc. Treatment options for overall disease control
limited to immunosuppressive drugs.
RESOLVE-1 has enrolled 365 individuals with SSc
in an international, multicenter, randomized, double-blind,
placebo-controlled study that is being conducted in North America,
Europe, Israel, Japan, South Korea and Australia. Corbus expects to
report topline results from the study in the summer of 2020, with
commercialization in 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,
Topline Data Expected in 2021
- DM is a rare and serious autoimmune
disease characterized by skin and muscle inflammation affecting
~80,000 people in the U.S., EU and Japan. Five-year mortality is as
high as 30%.
- Enrollment is ongoing in 150
patient Phase 3 study with the American College of
Rheumatology/European League Against Rheumatism 2016 Total
Improvement Score in myositis as the primary efficacy
endpoint.
- Data from the Phase 2 open-label
extension was recently presented at the annual EULAR 2019
conference and showed continued favorable safety and durable
improvement in efficacy outcomes:
- CDASI activity score reached -21.8
points at 16 months in dermatomyositis OLE study
- 90% dermatomyositis subjects remain
in OLE at ≥ 16 months
- No serious or severe AEs related to
lenabasum reported in the study to date
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,
supported by a Development Award for up to $25 Million from the
Cystic Fibrosis Foundation, Topline Data Expected in Summer of
2020
- 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 415 patient Phase 2b study with the event rate of pulmonary
exacerbations (PEx) as the primary efficacy endpoint. Pulmonary
exacerbations are a clinically relevant event of worsening of
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.
- There continues to be an unmet need
for drugs that reduce rate and severity of PEx in people with
CF.
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, Topline Data Expected in 2020
- Enrollment and dosing are ongoing
in 100 patient Phase 2 study being conducted and funded by the
National Institutes of Health (NIH).
- SLE 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.
- 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, Selective
Cannabinoid Receptor Type 1 (CB1) Inverse Agonist Targeting Liver
Fibrosis, Designed to be Peripherally Restricted
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), 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. We expect this to be
followed by an NIH-funded study of blood brain barrier penetration
by CRB-4001, then a biomarker study in people with metabolic
syndrome or NASH.
CRB-4001 is not approved for the treatment of NASH.
Fueling the Future Growth of the Clinical Pipeline –
Library of >700 Unique Early Stage Drug Compounds Targeting the
Endocannabinoid System
Corbus is actively leveraging its proprietary
library of >700 unique early stage compounds to develop
endocannabinoid mimetics targeting inflammatory, fibrotic, and
metabolic diseases. The Company recently introduced its first group
of compounds, including both novel CB2 agonists and novel CB1
inverse agonists, generated from its proprietary platform at its
R&D day hosted on June 21, 2019 in New York. The compounds are
structurally distinct, and each has so far generated a unique
profile of effects on inflammation and fibrosis.
Corbus plans to continue exploring the potential
of its proprietary platform and advance its library of early stage
compounds by transitioning to animal models, selecting initial
indications and routes of administration, as well as establishing
partnerships with pharmaceutical partners where applicable.
Summary of Financial Results for Second Quarter 2019
Ended June 30, 2019
For the quarter ended June 30, 2019, the Company
reported net income of approximately $2,153,000 or net income per
diluted share of $0.03, compared to a net loss of approximately
$12,100,000, or a net loss per diluted share of $0.21, for the
quarter ended June 30, 2018. For the quarter ended June 30, 2019,
revenue from awards increased by approximately $1.2 million to $2.1
million due to revenue recognized from the Development Award
Agreement with the Cystic Fibrosis Foundation. Revenue for the
quarter ended June 30, 2019 also included $27 million from the
up-front licensing payment received from Kaken Pharmaceuticals in
March 2019.
Operating expenses for the quarter ended June
30, 2019 increased by approximately $14.1 million to $27.4 million.
The increase was attributable to increased spending for clinical
studies, the costs to manufacture and supply lenabasum for clinical
trials, staffing costs, a $1.0 million increase in non-cash stock
compensation expenses and a $2.7 million sub-royalty payment paid
to the CF Foundation as a result of the $27 million up-front
licensing payment received from Kaken Pharmaceuticals.
The Company ended the quarter with $73.2 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 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, August 8 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) and has been designed to resolve
inflammation, limit fibrosis and support tissue repair. CB2 is
preferentially expressed on activated immune cells and on
fibroblasts, muscle cells, and endothelial cells. In both animal
and human studies conducted to date, lenabasum has induced the
production of pro-resolving lipid mediators that activate
endogenous pathways which resolve inflammation and speed bacterial
clearance without immunosuppression. 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 patients with
DM with active skin involvement but not currently active muscle
involvement. 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 to confirm these results and support applications for
regulatory approval.
About CRB-4001
CRB-4001 is a 2nd generation, selective
cannabinoid receptor type 1 (CB1) inverse agonist designed to be
peripherally restricted. Preclinical data show CRB-4001 improves
inflammation and has multiple effects on metabolic function
relevant to the treatment of nonalcoholic steatohepatitis (NASH).
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. We expect this to be followed by an NIH-funded
study of blood brain barrier penetration by CRB-4001, then a
biomarker study in people with metabolic syndrome or NASH.
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 700 novel compounds 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 to initiate a Phase 1 study
for CRB-4001 in 2019. We expect this to be followed by an
NIH-funded study of blood brain barrier penetration by CRB-4001,
then a biomarker study in people with metabolic syndrome or
NASH.
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
|
|
June 30, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
(unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
73,154,916 |
|
|
$ |
41,748,468 |
|
Prepaid expenses and other current assets |
|
|
2,235,947 |
|
|
|
2,491,844 |
|
Total current assets |
|
|
75,390,863 |
|
|
|
44,240,312 |
|
Property and equipment,
net |
|
|
2,912,335 |
|
|
|
2,705,206 |
|
Operating lease right of use
assets |
|
|
5,695,689 |
|
|
|
— |
|
Other assets |
|
|
123,226 |
|
|
|
43,823 |
|
Total assets |
|
$ |
84,122,113 |
|
|
$ |
46,989,341 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Notes payable |
|
$ |
99,333 |
|
|
$ |
394,305 |
|
Accounts payable |
|
|
7,490,561 |
|
|
|
6,345,335 |
|
Accrued expenses |
|
|
19,056,618 |
|
|
|
9,851,191 |
|
Deferred revenue |
|
|
2,482,238 |
|
|
|
1,462,503 |
|
Operating lease liabilities, current |
|
|
312,289 |
|
|
|
— |
|
Deferred rent, current |
|
|
— |
|
|
|
35,996 |
|
Total current liabilities |
|
|
29,441,039 |
|
|
|
18,089,330 |
|
Operating lease liabilities,
noncurrent |
|
|
7,307,274 |
|
|
|
— |
|
Deferred rent, noncurrent |
|
|
— |
|
|
|
1,375,891 |
|
Total liabilities |
|
|
36,748,313 |
|
|
|
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 June 30, 2019 and December
31, 2018 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 150,000,000 shares authorized,
64,644,093 and 57,247,496 shares issued and outstanding at June 30,
2019 and December 31, 2018 |
|
|
6,465 |
|
|
|
5,725 |
|
Additional paid-in capital |
|
|
192,819,731 |
|
|
|
148,888,635 |
|
Accumulated deficit |
|
|
(145,452,396 |
) |
|
|
(121,370,240 |
) |
Total stockholders’ equity |
|
|
47,373,800 |
|
|
|
27,524,120 |
|
Total liabilities and stockholders’ equity |
|
$ |
84,122,113 |
|
|
$ |
46,989,341 |
|
Corbus Pharmaceuticals Holdings, Inc.Condensed
Consolidated Statements of Operations(Unaudited)
|
|
For the Three Months Ended |
|
|
For the Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenue from awards and
licenses |
|
$ |
29,094,583 |
|
|
$ |
853,646 |
|
|
$ |
30,980,265 |
|
|
$ |
1,804,088 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
22,181,409 |
|
|
|
10,259,868 |
|
|
|
43,965,113 |
|
|
|
20,025,229 |
|
General and administrative |
|
|
5,207,962 |
|
|
|
2,987,549 |
|
|
|
11,832,709 |
|
|
|
6,037,581 |
|
Total operating expenses |
|
|
27,389,371 |
|
|
|
13,247,417 |
|
|
|
55,797,822 |
|
|
|
26,062,810 |
|
Operating income (loss) |
|
|
1,705,212 |
|
|
|
(12,393,771 |
) |
|
|
(24,817,557 |
) |
|
|
(24,258,722 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
448,717 |
|
|
|
266,297 |
|
|
|
783,312 |
|
|
|
469,717 |
|
Foreign currency exchange gain (loss), net |
|
|
(1,276 |
) |
|
|
58,123 |
|
|
|
(47,911 |
) |
|
|
24,269 |
|
Other income, net |
|
|
447,441 |
|
|
|
324,420 |
|
|
|
735,401 |
|
|
|
493,986 |
|
Net income (loss) |
|
$ |
2,152,653 |
|
|
$ |
(12,069,351 |
) |
|
$ |
(24,082,156 |
) |
|
$ |
(23,764,736 |
) |
Net income (loss) per share,
basic |
|
$ |
0.03 |
|
|
$ |
(0.21 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.42 |
) |
Weighted average number of
common shares outstanding, basic |
|
|
64,546,628 |
|
|
|
57,157,955 |
|
|
|
63,119,196 |
|
|
|
56,764,935 |
|
Net income (loss) per share,
diluted |
|
$ |
0.03 |
|
|
$ |
(0.21 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.42 |
) |
Weighted average number of
common shares outstanding, diluted |
|
|
68,511,587 |
|
|
|
57,157,955 |
|
|
|
63,119,196 |
|
|
|
56,764,935 |
|
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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