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 reported financial results for the first quarter of
2020. The Company also provided clinical and corporate updates.
“We had a busy first quarter as we implemented a
comprehensive mitigation and monitoring COVID-19 plan to help
ensure the integrity of our clinical programs. As a result of this
plan, we are reiterating that we continue to expect topline data
for RESOLVE-1 this summer, followed by our Phase 2b study results
in cystic fibrosis,” said Yuval Cohen, Ph.D, Chief Executive
Officer. “We are grateful to the patients, physicians, site staff
and our own employees who remain committed to these studies and for
the significant additional effort that they provided to overcome
this unique challenge. Our other programs remain on track, with
focused emphasis on preparations for potential lenabasum NDA
submission, FDA approval and commercial launch. Lastly, our
organization is functioning well with remote working
practices.”
Recent Corporate Highlights and
Achievements:
- Implemented COVID-19 mitigation plan to ensure safety of
employees and adequate oversight of safety of subjects in ongoing
studies while maintaining data integrity in our studies.
- In February, raised $46 million in gross proceeds from a public
offering of 7,666,667 shares of common stock, priced at $6.00 per
share, including 1,000,000 shares sold pursuant to the full
exercise of the underwriters’ option to purchase additional
shares.
- In March, announced the appointment of Pete Salzmann, M.D.,
MBA, to the Board of Directors. Dr. Salzmann brings 20 years of
industry experience with a track record of successfully launching
and commercializing a number of drugs, including autoimmune
products.
- Commercial launch preparation activities for lenabasum in
systemic sclerosis and cystic fibrosis are advancing. Corbus
introduced a disease education campaign called “Total SSc” to
educate healthcare providers on total disease burden of systemic
sclerosis, current treatment limitations, and potential new
treatment approach of targeting the endocannabinoid
system.
- Published previously reported Phase 2 safety and efficacy
results of lenabasum in randomized, placebo-controlled trial of
adults with systemic sclerosis in Arthritis and Rheumatology, the
official journal of the American College of Rheumatology.
Clinical Program Updates:
Lenabasum: a novel, oral, selective cannabinoid receptor
type 2 (CB2) agonist
- Topline results for lenabasum systemic sclerosis study remain
on schedule for summer 2020, followed by cystic fibrosis study
results.
- Systemic Sclerosis (SSc) – Phase 3 “RESOLVE-1” topline results
in SSc, a rare disease and the most lethal of the systemic
autoimmune diseases, remain on track for the summer of 2020. The
multicenter study of 365 patients is randomized 1:1:1 for twice a
day dosing of lenabasum at 5 mg, 20 mg, or placebo for 52 weeks,
with a 4-week follow up. The primary endpoint is ACR CRISS score.
The open-label extension of this study is active.
- Cystic fibrosis (CF) – Phase 2b topline results of lenabasum in
people with CF who are at high-risk for recurrent pulmonary
exacerbation expected following RESOLVE-1 data results. The
multicenter study of 426 patients is randomized 1:2:2 for twice a
day dosing of lenabasum at 5 mg, 20 mg, or placebo for 28 weeks,
with a 4-week follow up. The primary endpoint is event rate of
pulmonary exacerbation.
- Dermatomyositis (DM) – Phase 3 “DETERMINE” study in DM, a rare
and life-threatening autoimmune disease characterized by skin and
muscle inflammation, is ongoing with enrollment expected to be
completed in 2020, and topline data expected in 2021. The
double-blind, randomized, placebo controlled, multinational study
expects to enroll 150 subjects. The primary endpoint is ACR / EULAR
2016 Total Improvement Score (TIS) in Adult Dermatomyositis &
Polymyositis. The open-label extension of this study is already
active.
- Systemic Lupus Erythematosus – The randomized, double-blind,
placebo-controlled, U.S. study, funded and managed by the National
Institutes of Health (NIH), has enrolled 86/100 patients to
date.
CRB-4001:
a peripherally restricted CB1 inverse agonist potentially for
NASH
·Phase 1
study of CRB-4001 continues to be expected to commence in the third
quarter of 2020. The study will evaluate the safety, tolerability
and pharmacokinetics of CRB-4001. CRB-4001 has demonstrated potent
effects on glucose tolerance, insulin sensitivity, lipid
metabolism, body fat, and hepatic fat in animal models of disease,
with robust literature supporting these beneficial metabolic
effects.
Additional Candidate Compounds
·Corbus anticipates the
selection of an additional candidate compound this year for IND
enabling pre-clinical studies.
Financial Results for First Quarter Ended March 31,
2020:
For the quarter ended March 31, 2020, the
Company reported a net loss of approximately $29,657,000 or a net
loss per diluted share of $0.43, compared to a net loss of
approximately $26,235,000, or a net loss per diluted share of
$0.43, for the quarter ended March 31, 2019.
For the quarter ended March 31, 2020 revenue
decreased by approximately $0.1 million to $1.8 million, due to a
decrease in the revenue from the $25 million Development Award from
the Cystic Fibrosis Foundation.
Operating expenses for the quarter ended March
31, 2020 increased by approximately $3.2 million to $31.6 million.
The increase was attributable to clinical studies costs, the costs
to manufacture and supply lenabasum for clinical trials, staffing
costs, commercialization costs and non-cash stock compensation
expense.
The Company completed a public offering in
February 2020 that raised approximately $43 million in net
proceeds. The Company ended the quarter with approximately $46.6
million in cash and cash equivalents and expects its cash and cash
equivalents on hand at March 31, 2020 together with the $7.5
million remainder of the expected milestone payments from the $25
million Development Award from the Cystic Fibrosis Foundation to
fund operations into the fourth quarter of 2020.
Conference Call and Webcast Information:
Corbus management will host a conference call
and webcast presentation for investors, analysts and other
interested parties today, Monday, May 11, 2020 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.
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. For more information on Corbus’ clinical programs,
please visit here.
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,
including the potential impact of the recent COVID-19 pandemic,
including 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.
Corbus Pharmaceuticals Holdings, Inc.
Condensed Consolidated Balance Sheets
|
|
March 31, |
|
December 31, |
|
|
2020 |
|
2019 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
46,617,921 |
|
|
$ |
31,748,686 |
|
Prepaid expenses and other current assets |
|
|
3,596,908 |
|
|
|
3,724,932 |
|
Contract asset |
|
|
4,443,124 |
|
|
|
2,681,065 |
|
Total current assets |
|
|
54,657,953 |
|
|
|
38,154,683 |
|
Property and equipment,
net |
|
|
4,851,317 |
|
|
|
5,083,865 |
|
Operating lease right of use
asset |
|
|
5,680,467 |
|
|
|
5,818,983 |
|
Other assets |
|
|
14,085 |
|
|
|
84,968 |
|
Total assets |
|
$ |
65,203,822 |
|
|
$ |
49,142,499 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Notes payable |
|
$ |
432,905 |
|
|
$ |
752,659 |
|
Accounts payable |
|
|
9,960,544 |
|
|
|
11,091,363 |
|
Accrued expenses |
|
|
23,516,354 |
|
|
|
22,447,939 |
|
Operating lease liabilities, current |
|
|
742,893 |
|
|
|
595,745 |
|
Total current liabilities |
|
|
34,652,696 |
|
|
|
34,887,706 |
|
|
|
|
|
|
|
|
|
|
Operating lease liabilities,
noncurrent |
|
|
7,859,636 |
|
|
|
8,097,228 |
|
Total liabilities |
|
|
42,512,332 |
|
|
|
42,984,934 |
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
|
|
Preferred Stock $0.0001 par value:10,000,000 shares authorized, no
shares issued and outstanding at March 31, 2020 and December 31,
2019 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 150,000,000 shares authorized,
72,490,449 and 64,672,893 shares issued and outstanding at March
31, 2020 and December 31, 2019, respectively |
|
|
7,249 |
|
|
|
6,467 |
|
Additional paid-in capital |
|
|
245,164,999 |
|
|
|
198,975,056 |
|
Accumulated deficit |
|
|
(222,480,758 |
) |
|
|
(192,823,958 |
) |
Total stockholders’ equity |
|
|
22,691,490 |
|
|
|
6,157,565 |
|
Total liabilities and stockholders’ equity |
|
$ |
65,203,822 |
|
|
$ |
49,142,499 |
|
Corbus Pharmaceuticals Holdings, Inc.
Consolidated Statements of
Operations(Unaudited)
|
|
For the Three Months Ended March 31, |
|
|
2020 |
|
2019 |
Revenue from awards |
|
$ |
1,762,059 |
|
|
$ |
1,885,682 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
23,947,866 |
|
|
|
21,783,704 |
|
General and administrative |
|
|
7,699,479 |
|
|
|
6,624,747 |
|
Total operating expenses |
|
|
31,647,345 |
|
|
|
28,408,451 |
|
Operating loss |
|
|
(29,885,286 |
) |
|
|
(26,522,769 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest income, net |
|
|
101,993 |
|
|
|
334,595 |
|
Foreign currency exchange gain (loss), net |
|
|
126,493 |
|
|
|
(46,635 |
) |
Other income, net |
|
|
228,486 |
|
|
|
287,960 |
|
Net loss |
|
$ |
(29,656,800 |
) |
|
$ |
(26,234,809 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.43 |
) |
Weighted average number of
common shares outstanding, basic and diluted |
|
|
69,272,402 |
|
|
|
61,675,904 |
|
Corbus Pharmaceuticals Contacts: Ted Jenkins,
Senior Director, Investor Relations and Corporate Communications
Phone: +1 (617) 415-7745 Email: ir@corbuspharma.com
Lindsey Smith, Director, Investor Relations and Corporate
Communications Phone: +1 (617) 415-7749 Email:
mediainfo@corbuspharma.com
Christina Tartaglia Stern IR, Inc. Phone: +1 (212) 362-1200
Email: christina.targaglia@sternir.com
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