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 second quarter of
2020. The Company also provided clinical and corporate updates.
“We had a busy second quarter as we prepare for
a potentially transformative second half of the year with two
expected data readouts, including topline data in our Phase 3 study
for systemic sclerosis this summer, followed by our Phase 2b study
in cystic fibrosis. We recently announced that we completed sales
of $71 million through our ATM program and entered a debt financing
agreement for up to $50 million with the first $20 million already
received, strengthening our balance sheet and putting us in a solid
financial position before topline data,” said Yuval Cohen, Ph.D.,
Chief Executive Officer. “We have also appointed a new board
member, Dr. George Golumbeski who brings considerable expertise in
corporate and business development. With these recent updates, a
strong balance sheet and the critical data readouts now closer than
ever, we continue to prepare the groundwork for NDA submission and
commercialization following potential FDA approval.”
Recent Corporate Highlights and
Achievements:
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Strengthened the Company’s balance sheet with up to $121 million in
new capital, bolstering its strategic flexibility. The Company
received an aggregate of $71 million in gross proceeds from its
at-the-market offering coupled with the execution of a $50 million
debt financing facility with K2 HealthVentures, a
healthcare-focused specialty finance company. |
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In July, Corbus announced the appointment of George Golumbeski,
Ph.D., to its Board of Directors. Dr. Golumbeski brings years of
industry experience with a track record of growing companies and
advancing innovation. During his corporate career, Dr. Golumbeski
held senior leadership positions in business development at
Celgene, Novartis, Elan Pharmaceuticals and Schwarz Pharma. |
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The Company presented at several conferences during the second
quarter. In May, Corbus announced the publication of two abstracts
at the European League Against Rheumatism (“EULAR”) 2020
E-Congress. The first abstract highlighted pre-clinical data
suggesting that biologic effects of lenabasum include inhibition of
inflammasome activation. The second abstract outlined baseline
characteristics of RESOLVE-1 patients in the European Union.
Additionally, new data from the lenabasum Phase 2 open-label
extension study were presented at the 6th Systemic Sclerosis World
E-Congress. Analyses show the American College of Rheumatology
Combined Response Index in diffuse cutaneous Systemic Sclerosis
(“ACR CRISS”) score correlates with improvements from baseline in
how patients feel and function. The presentations are available in
the Scientific Conferences section of Corbus’ website. |
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In June, the Company announced the publication of baseline patient
demographics and disease characteristics in its Phase 2b study of
lenabasum in cystic fibrosis. The information was published in
an electronic supplement of the Journal of Cystic Fibrosis in
connection with the 43rd European Cystic Fibrosis Conference. |
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Lenabasum recently received Orphan Drug Designation for systemic
sclerosis from Japan’s PMDA. |
Clinical Program Updates:
Lenabasum: a novel, oral, selective cannabinoid receptor
type 2 (CB2) agonist
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● |
Systemic Sclerosis (SSc) – Last subject visit in RESOLVE-1 Phase 3
study of lenabasum for treatment of systemic sclerosis was
announced on May 27. Topline results in SSc, a rare disease and the
most lethal of the systemic autoimmune diseases, remain on track
for this summer. 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 the ACR CRISS score. The open-label extension of this
study is active. There are no FDA-approved therapies for the
overall treatment of SSc. |
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Cystic Fibrosis (CF) – Last subject visit in Phase 2b study of
lenabasum for CF was announced on June 22. Phase 2b topline results
of lenabasum in patients with CF who are at high-risk for recurrent
pulmonary exacerbation will follow the RESOLVE-1 data results in
the third quarter of 2020. The multicenter study of 425 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 (“PEx”). Treatment
of inflammation to reduce PEx remains a key unmet need in CF. |
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Dermatomyositis (DM) – Phase 3 “DETERMINE” study in DM, a rare and
life-threatening autoimmune disease characterized by skin and
muscle inflammation, is ongoing. Last subject’s first visit in the
double-blind, randomized, placebo controlled, multinational
DETERMINE study of lenabasum DM was announced on August 5 with 176
subjects enrolled, with topline data expected in the fourth quarter
of 2021. The primary endpoint is ACR / EULAR 2016 Total Improvement
Score (“TIS”) in Adult Dermatomyositis & Polymyositis. The
open-label extension of this study is active. There is significant
unmet need for new treatments to achieve disease control in DM
because of limited efficacy or toxicity of immunosuppressive agents
or refractory disease. |
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Systemic Lupus Erythematosus (SLE) – Phase 2b study is ongoing. The
study, funded and managed by the National Institutes of Health
(NIH), is enrolling at 15 sites in the U.S., with enrollment
expected to be completed by end of this year or early 2021. |
CRB-4001: a peripherally restricted CB1 inverse agonist
and additional candidate compounds
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Nonalcoholic fatty liver disease (NAFLD/NASH) – CRB-4001 is a CB1
inverse agonist which improves metabolic abnormalities and reduces
inflammation and fibrosis in non-clinical models of disease.
CRB-4001 is undergoing chronic pharmacokinetic studies in primates
to measure brain exposure to CRB-4001. Results of these studies are
expected this year and will be considered in the design of Phase 1
studies. |
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Corbus has selected CRB-317 as an additional candidate to add to
its pipeline. CRB-317 is a CB2 agonist that has significant potency
and selectivity for CB2 and biological activity in animal models of
inflammation and fibrosis. IND enabling pre-clinical studies and
formulation work are underway. Phase 1 safety testing is expected
in 2021. |
Financial Results for Second Quarter Ended June 30,
2020:
For the quarter ended June 30, 2020, the Company
reported a net loss of approximately $38.1 million or a net loss
per diluted share of $0.52, compared to net income of approximately
$2.2 million or net income per diluted share of $0.03, for the
quarter ended June 30, 2019.
For the quarter ended June 30, 2020 revenue
decreased by approximately $28.8 million to $0.3 million, due
primarily to revenue for the quarter ended June 30, 2019 including
$27 million from the up-front licensing payment received from Kaken
Pharmaceuticals in March 2019.
Operating expenses for the quarter ended June
30, 2020 increased by approximately $11.0 million to $38.4 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.
On July 29, 2020, Corbus announced that it
received an aggregate of $71 million in gross proceeds from its
at-the-market (“ATM”) offering coupled with the execution of a $50
million debt financing facility with K2 HealthVentures. Pursuant to
the previously disclosed $75 million ATM facility, Corbus sold
9,167,080 shares at a weighted average price of $7.70 per share.
Corbus has received the first $20 million tranche from the debt
financing facility and has the option to draw $20 million from the
second tranche and $10 million from the third tranche, in each case
upon achievement of certain regulatory and developmental
milestones.
Corbus expects its cash and cash equivalents on
hand of approximately $101 million at July 28, 2020 to fund
operations into the third quarter of 2021.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 6, 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.
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 and
the potential impact of 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
|
|
June 30, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
|
(unaudited) |
|
|
|
|
ASSETS |
|
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|
|
|
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|
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Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
63,468,769 |
|
|
$ |
31,748,686 |
|
Customer receivable |
|
$ |
5,000,000 |
|
|
$ |
— |
|
Stock subscriptions receivable |
|
$ |
16,675,971 |
|
|
$ |
— |
|
Prepaid expenses and other current assets |
|
|
2,872,275 |
|
|
|
3,724,932 |
|
Contract asset |
|
|
— |
|
|
|
2,681,065 |
|
Total current assets |
|
|
88,017,015 |
|
|
|
38,154,683 |
|
Property and equipment,
net |
|
|
4,547,303 |
|
|
|
5,083,865 |
|
Operating lease right of use
assets |
|
|
5,539,677 |
|
|
|
5,818,983 |
|
Other assets |
|
|
14,085 |
|
|
|
84,968 |
|
Total assets |
|
$ |
98,118,080 |
|
|
$ |
49,142,499 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
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Current liabilities: |
|
|
|
|
|
|
|
|
Notes payable |
|
$ |
108,936 |
|
|
$ |
752,659 |
|
Accounts payable |
|
|
12,697,845 |
|
|
|
11,091,363 |
|
Accrued expenses |
|
|
28,144,144 |
|
|
|
22,447,939 |
|
Deferred revenue |
|
|
270,530 |
|
|
|
— |
|
Operating lease liabilities, current |
|
|
873,525 |
|
|
|
595,745 |
|
Total current liabilities |
|
|
42,094,980 |
|
|
|
34,887,706 |
|
|
|
|
|
|
|
|
|
|
Operating lease liabilities,
noncurrent |
|
|
7,609,221 |
|
|
|
8,097,228 |
|
Total liabilities |
|
|
49,704,201 |
|
|
|
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 June 30, 2020 and December 31,
2019 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 150,000,000 shares authorized,
80,655,848 and 64,672,893 shares issued and outstanding at June 30,
2020 and December 31, 2019, respectively |
|
|
8,065 |
|
|
|
6,467 |
|
Additional paid-in capital |
|
|
308,991,895 |
|
|
|
198,975,056 |
|
Accumulated deficit |
|
|
(260,586,081 |
) |
|
|
(192,823,958 |
) |
Total stockholders’ equity |
|
|
48,413,879 |
|
|
|
6,157,565 |
|
Total liabilities and stockholders’ equity |
|
$ |
98,118,080 |
|
|
$ |
49,142,499 |
|
Corbus Pharmaceuticals Holdings, Inc.Condensed
Consolidated Statements of Operations(Unaudited)
|
|
For the Three Months Ended |
|
|
For the Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenue from awards and
licenses |
|
$ |
286,346 |
|
|
$ |
29,094,583 |
|
|
$ |
2,048,405 |
|
|
$ |
30,980,265 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
30,686,071 |
|
|
|
22,181,409 |
|
|
|
54,633,937 |
|
|
|
43,965,113 |
|
General and administrative |
|
|
7,738,968 |
|
|
|
5,207,962 |
|
|
|
15,438,447 |
|
|
|
11,832,709 |
|
Total operating expenses |
|
|
38,425,039 |
|
|
|
27,389,371 |
|
|
|
70,072,384 |
|
|
|
55,797,822 |
|
Operating income (loss) |
|
|
(38,138,693 |
) |
|
|
1,705,212 |
|
|
|
(68,023,979 |
) |
|
|
(24,817,557 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
12,649 |
|
|
|
448,717 |
|
|
|
114,642 |
|
|
|
783,312 |
|
Foreign currency exchange gain (loss), net |
|
|
20,721 |
|
|
|
(1,276 |
) |
|
|
147,214 |
|
|
|
(47,911 |
) |
Other income, net |
|
|
33,370 |
|
|
|
447,441 |
|
|
|
261,856 |
|
|
|
735,401 |
|
Net income (loss) |
|
$ |
(38,105,323 |
) |
|
$ |
2,152,653 |
|
|
$ |
(67,762,123 |
) |
|
$ |
(24,082,156 |
) |
Net income (loss) per share,
basic |
|
$ |
(0.52 |
) |
|
$ |
0.03 |
|
|
$ |
(0.95 |
) |
|
$ |
(0.38 |
) |
Weighted average number of
common shares outstanding, basic |
|
|
73,885,548 |
|
|
|
64,546,628 |
|
|
|
71,578,975 |
|
|
|
63,119,196 |
|
Net income (loss) per share,
diluted |
|
$ |
(0.52 |
) |
|
$ |
0.03 |
|
|
$ |
(0.95 |
) |
|
$ |
(0.38 |
) |
Weighted average number of
common shares outstanding, diluted |
|
|
73,885,548 |
|
|
|
68,511,587 |
|
|
|
71,578,975 |
|
|
|
63,119,196 |
|
Corbus Pharmaceuticals Contacts:
Ted Jenkins, Senior Director, Investor Relations and Corporate
CommunicationsPhone: +1 (617) 415-7745Email:
ir@corbuspharma.com
Lindsey Smith, Director, Investor Relations and Corporate
CommunicationsPhone: +1 (617) 415-7749Email:
mediainfo@corbuspharma.com
Christina Tartaglia Stern IR, Inc.Phone: +1 (212) 362-1200Email:
christina.tartaglia@sternir.com
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