Full Press Release Details
Pharmaceuticals Reports 2016 Third Quarter Financial Results and Provides Business Update
Topline data for Phase 2 study of systemic sclerosis on track to be reported in fourth quarter of 2016 -
Topline data for Phase 2 study of cystic fibrosis on track to be reported in first quarter of 2017 -
MA (November 10, 2016) - Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"),
a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, announced today
its financial results for the three months ended September 30, 2016.
Company also provided an update to its corporate progress and the clinical status and anticipated milestones for Resunab, its
novel synthetic oral endocannabinoid-mimetic drug that is designed to resolve chronic inflammation and halt fibrosis. Resunab
is currently being evaluated in three separate Phase 2 clinical studies in diffuse cutaneous systemic sclerosis ("systemic
sclerosis"), cystic fibrosis ("CF"), and skin-predominant dermatomyositis. A fourth NIH-sponsored
clinical study of Resunab in systemic lupus erythematosus ("SLE") is planned to begin during the first half of 2017.
Corporate Highlights
| Received Orphan Designation for Resunab in the treatment of CF in the European Union; | ||
| Announced the completion of Phase 2 study of Resunab for systemic sclerosis; | ||
| Presented preliminary data on the mechanism of action of Resunab in a clinical research model of inflammation and its resolution in healthy volunteers at the 6 th European Workshop on Lipid Mediators; and | ||
| Announced the completion of patient enrollment of Phase 2 clinical study of Resunab in CF. |
are pleased with the progress we have made over the course of 2016 and our ability to execute a complex clinical development program.
We look forward to clinical data from our three current Phase 2 studies," stated Yuval Cohen, Ph.D., Chief Executive Officer
Near-Term Milestones
| Report topline data from systemic sclerosis study in Q4 2016; | ||
| Complete dosing in Phase 2 clinical studies for CF in Q4 2016, report topline results of the study in Q1 2017; | ||
| Continue open-label extension study in systemic sclerosis; | ||
| Complete enrollment of Phase 2 clinical study in dermatomyositis in Q2 2017; | ||
| Seek Orphan Drug Designation in Europe for the treatment of systemic sclerosis by the end of 2016; | ||
| Complete additional pre-clinical mechanism of action studies; and | ||
| Launch of the Phase 2 clinical study in patients with SLE expected in H1 2017. |
forward, we continue our commitment to clinically advance Resunab as a potential therapy for individuals with serious inflammatory
and fibrotic diseases," concluded Dr. Cohen.
of Financial Results for Third Quarter 2016
the three months ended September 30, 2016, the Company reported a net loss of approximately $5,347,000, or a net loss per diluted
share of $0.12, compared to a net loss of approximately $2,254,000, or a net loss per diluted share of $0.06 for the three months
ended September 30, 2015.
the nine months ended September 30, 2016, the Company reported a net loss of approximately $12,428,000, or a net loss per diluted
share of $0.31, compared to a net loss of approximately $6,352,000, or a net loss per diluted share of $0.22 for the nine months
ended September 30, 2015.
increases in the net losses for the three and the nine months ended September 30, 2016 are attributable to increased spending
on clinical studies for systemic sclerosis and CF and increased compensation related to increased staffing, bonuses, and
stock-based compensation expense.
Company ended the quarter with approximately $18.9 million of cash and cash equivalents. The Company expects the cash
on hand together with the remaining milestone payments of $1,500,000 from the Cystic Fibrosis Foundation Therapeutics, Inc., which
the Company expects to receive in the first quarter of 2017, to be sufficient to meet its operating and capital requirements into
the fourth quarter of 2017 based on current planned expenditures.
is a novel synthetic oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor expressed on activated immune
cells and fibroblasts. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Preclinical and
Phase 1 studies have shown Resunab to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated
promising potency in preclinical models of inflammation and fibrosis. Resunab is designed to trigger the production of "Specialized
Pro-resolving Lipid Mediators" that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis,
while reducing production of multiple inflammatory mediators. Resunab has direct effects on fibroblasts to halt tissue scarring.
In effect, Resunab triggers endogenous pathways to turn "off" chronic inflammation and fibrotic processes, without
causing immunosuppression.
Pharmaceuticals Holdings, Inc. is a clinical stage pharmaceutical company focused on the development and commercialization of
novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. Our lead product candidate, Resunab,
is a novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation, and fibrotic processes. Resunab
is currently in Phase 2 clinical studies for the treatment of cystic fibrosis, diffuse cutaneous systemic sclerosis and skin-predominant
dermatomyositis, with a fourth Phase 2 trial in systemic lupus erythematosus planned to commence during the first half of 2017.
more information, please visit www.CorbusPharma.com and connect with the Company on Twitter, LinkedIn, Google+ and Facebook.
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.
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.
Pharmaceuticals Holdings, Inc.
Consolidated Statements of Operations
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Collaboration revenue | $ | 742,558 | $ | 170,454 | $ | 1,535,754 | $ | 284,090 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,315,632 | 1,634,800 | 10,056,568 | 4,065,486 | ||||||||||||
| General and administrative | 1,760,696 | 790,576 | 3,891,810 | 2,571,521 | ||||||||||||
| Total operating expenses | 6,076,328 | 2,425,376 | 13,948,378 | 6,637,007 | ||||||||||||
| Operating loss | (5,333,770 | ) | (2,254,922 | ) | (12,412,624 | ) | (6,352,917 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 1,731 | 1,037 | 420 | 773 | ||||||||||||
| Foreign currency exchange loss | (14,729 | ) | - | (16,196 | ) | - | ||||||||||
| Other income (expense), net | (12,998 | ) | 1,037 | (15,776 | ) | 773 | ||||||||||
| Net loss | $ | (5,346,768 | ) | $ | (2,253,885 | ) | $ | (12,428,400 | ) | $ | (6,352,144 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.06 | ) | $ | (0.31 | ) | $ | (0.22 | ) | ||||
| Weighted average number of common shares outstanding, basic and diluted | 43,783,504 | 34,770,597 | 40,059,364 | 29,242,236 |
Pharmaceuticals Holdings, Inc.
Consolidated Balance Sheets
| September 30, 2016 | December 31, 2015 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 18,909,348 | $ | 12,338,275 | ||||
| Prepaid expenses | 315,798 | 376,515 | ||||||
| Total current assets | 19,225,146 | 12,714,790 | ||||||
| Restricted cash | 186,375 | 36,375 | ||||||
| Property and equipment, net | 345,428 | 124,138 | ||||||
| Total assets | $ | 19,756,949 | $ | 12,875,303 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Notes payable | $ | - | $ | 162,019 | ||||
| Accounts payable | 2,768,490 | 1,314,377 | ||||||
| Accrued expenses | 2,342,852 | 562,279 | ||||||
| Deferred revenue, current | 1,315,865 | 1,591,358 | ||||||
| Total current liabilities | 6,427,207 | 3,630,033 | ||||||
| Deferred revenue, noncurrent | - | 260,260 | ||||||
| Other long-term liabilities | 15,503 | - | ||||||
| Total liabilities | 6,442,710 | 3,890,293 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2016 and December 31, 2015 | - | - | ||||||
| Common stock, $0.0001 par value; 150,000,000 shares authorized, 43,987,361 and 37,605,134 shares issued and outstanding at September 30, 2016 and December 31, 2015 | 4,399 | 3,761 | ||||||
| Additional paid-in capital | 39,016,054 | 22,259,063 | ||||||
| Accumulated deficit | (25,706,214 | ) | (13,277,814 | ) | ||||
| Total stockholders' equity | 13,314,239 | 8,985,010 | ||||||
| Total liabilities and stockholders' equity | $ | 19,756,949 | $ | 12,875,303 |
Thomas Communications, LLC
Corbus Pharmaceuticals Holdings, Inc.