Corbus Pharmaceuticals Reports 2014 Financial Results and Provides 2015 Business Update
(firmenpresse) - NORWOOD, MA -- (Marketwired) -- 02/10/15 -- (OTCQB: CRBP) (the "Company"), an emerging drug development company focused on the development and commercialization of its lead product candidate, ™, for the treatment of rare, life-threatening inflammatory and fibrotic diseases, announced today its financial results for the year ended December 31, 2014.
The Company also reviewed its corporate progress and anticipated near-term clinical development milestones for Resunab, a novel synthetic oral specialized pro-resolving mediator drug with unique anti-inflammatory and anti-fibrotic activity under development for the treatment of cystic fibrosis (CF) and diffuse cutaneous systemic sclerosis (scleroderma).
Filed an Investigational New Drug (IND) application for the Phase 2 scleroderma protocol for Resunab with the U.S. Food and Drug Administration (FDA);
Commenced trading of the Company''s common stock on the Over-the-Counter Markets under ticker symbol CRBP;
Appointed Barbara White, M.D., a leading board-certified rheumatologist, scleroderma expert and pharmaceutical industry veteran, as the Company''s Chief Medical Officer; and
Appointed Scott Constantine, M.S., former Director, Clinical Research & Operations at Insmed and Clinical Program Scientist at PTC Therapeutics with expertise in CF and pulmonary diseases, as the Company''s Director, Clinical Research & Operations.
"In the fourth quarter, we made good progress on the operational and regulatory fronts and believe 2014 was a springboard year by establishing the building blocks for Corbus to develop innovative therapies that target rare, life-threatening chronic inflammatory-fibrotic indications. We have assembled an experienced team of industry veterans that are working together to prepare and execute our clinical programs for Resunab," stated Yuval Cohen, Ph.D., Chief Executive Officer of Corbus Pharmaceuticals.
"We believe that Resunab''s novel and unique mechanism of action that acts by resolving inflammation has the potential to have a significant therapeutic impact on patients suffering from these diseases. We expect to continue to build forward momentum in the first half of 2015 with the initiation of our Phase 2 clinical trials with Resunab," added Dr. Cohen. "We are gratified to see that our hard work has been generating tangible results and look forward to a promising 2015."
Submit the clinical protocol for cystic fibrosis to the FDA under the Resunab IND and initiate the Phase 2 clinical trial for the treatment of CF in the second quarter of 2015;
Initiate the Phase 2 clinical study of Resunab for the treatment of scleroderma in the second quarter of 2015;
File the Resunab application for FDA Orphan Drug Designation for the treatment of both CF and scleroderma; and
Seek an up-listing to the NASDAQ Stock Market.
For the year ended December 31, 2014, the Company reported a net loss of approximately $2,540,000, or a net loss per diluted share of $0.13, compared to a net loss of approximately $602,000, or a net loss per diluted share, of $0.09 for the year ended December 31, 2013. The Company ended the year with approximately $6,262,000 of cash and cash equivalents.
Corbus expects its current cash on hand to be sufficient to meet its operating and capital requirements until at least the end of 2015.
Resunab™ is a novel synthetic oral drug with unique anti-inflammatory and anti-fibrotic activity. Pre-clinical and Phase 1 clinical studies have shown Resunab to have a favorable safety profile coupled with promising potency in pre-clinical models of inflammation and fibrosis. Resunab binds to the CB2 receptor on immune cells and triggers a process known as "inflammatory resolution," in effect turning chronic inflammation "off."
Corbus Pharmaceuticals is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare life-threatening inflammatory-fibrotic diseases with clear unmet medical needs. Our lead product candidate Resunab™ is a novel oral specialized pro-resolving mediator anti-inflammatory drug scheduled to commence Phase 2 clinical trials for the treatment of Cystic Fibrosis and Diffuse Cutaneous Systemic Sclerosis ("Scleroderma") in 2015. For more information, please visit .
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.
Jenene Thomas
Investor Relations and Corporate Communications Advisor
Jenene Thomas Communications, LLC
Phone: +1 (908) 938-1475
Email:
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Datum: 10.02.2015 - 06:05 Uhr
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