NEW YORK and LONDON, March 24, 2014 (GLOBE NEWSWIRE) -- Celsus Therapeutics Plc (Nasdaq:CLTX), an emerging growth, development-stage biotech company, today announced its financial results and provided a review of the twelve month period ended December 31, 2013.
"Last year was an exciting year for Celsus, as we evolved into a publicly traded and NASDAQ listed company, brought in a new management team, and raised a significant amount of capital from fundamental institutional health care funds to advance our clinical programs," said Dr. Gur Roshwalb, Chief Executive Officer of Celsus Therapeutics. "Looking forward into 2014, we are excited to continue to advance the MRX-6 program in the clinic, especially following our recent discussion with the FDA. We are confident that MRX-6 will be a significant treatment option for children and adults suffering from atopic dermatitis."
YEAR END 2013 FINANCIAL SUMMARY
At year end, December 31, 2013, Celsus had cash and cash equivalents of approximately $7.66 million, compared to $1.1 million at December 31, 2012. In addition, the Company raised an additional $9.2 million on February 5, 2014 in a public offering.
Research and development expenses for the year ended December 31, 2013 were $1.28 million, compared to $1.48 million for the year ended December 31, 2012. Celsus' net loss for the year ended December 31, 2013 was $3.62 million, or a net loss per share of $0.17, compared to a net loss of $4.3 million or net loss per share of $0.35 at December 31, 2012.
CORPORATE HIGHLIGHTS
On February 9, 2013, the Company began trading its American Depository Shares (ADS) on the OTC Bulletin Board. The ADS were listed on the NASDAQ Capital Market on January 30th, 2014, under the symbol "CLTX".
In March 2013, the Company announced that it had changed its name to Celsus Therapeutics and appointed Gur Roshwalb, MD, as Chief Executive Officer. Dr. Roshwalb joined Celsus from Venrock, a leading venture capital firm, where he most recently served as a Vice President investing in both private and public healthcare companies.
Throughout the year, the Company added several new members to its Board of Directors, complementing the strong industry experience of current board members David Sidransky, MD and Johnson Lau, MD. In April, Fredric Price, an industry veteran, joined the Board. He is the Executive Chairman of the Board of Directors of Chiasma, of which he was Chairman and Chief Executive Officer until stepping down as CEO after completing a strategic collaboration for its Phase 3 oral drug candidate in acromegaly with Roche. Robert J. Doman also joined the Celsus Board in May, with 30 years of pharmaceutical and medical leadership in dermatology. Additionally, Allan Shaw was named to the Board of Directors and serves as the Chairman of the Audit Committee. He currently leads Alvarez & Marsal's biopharmaceutical consulting practice and previously served as a member of the Board of Directors for the Central New York Biotech Accelerator as well as Chief Financial Officer of Merck Serono.
In May 2013, Celsus announced positive results from MRX-6 in the treatment of contact dermatitis, which demonstrated a 56% improvement in symptoms (dryness, scaling, redness, pruritus and fissures) from baseline in the MRX-6 treated hand/forearm, compared to a 24% improvement for vehicle ('placebo') treated hand/forearm (p < 0.0001). Clinically significant benefit, defined as a ≥ 50% reduction in symptoms from baseline in the MRX-6 treated hand/forearm was seen in 67% of patients.
In October 2013, Celsus' MRX-6 treatment for eczema was selected as one of the "Top 10 Autoimmune/Anti-Inflammatory Disease Projects to Watch" by Windhover Information of Elsevier Business Intelligence.
In addition, the Company also announced in October the appointment of Pablo Jimenez, MD, as Chief Medical Officer. Dr. Jimenez, who helped develop Elidel at Novartis, will advance the development of MRX-6 into additional trials, and continue development of the Celsus pipeline.
About MRX-6 – Dermatitis
MRX-6 is a Multi-Functional Anti-Inflammatory Drug (MFAID) topical cream under development for treating skin inflammatory disorders, specifically allergic contact dermatitis and atopic dermatitis, also known as eczema. MFAID's are designed to inhibit extracellular secretory phospholipase A2 (sPLA2), a catalytic enzyme responsible for initiating the inflammatory cascade through the production of arachidonic acid from membrane-associated phospholipids, specifically at the cell surface. MFAIDs can inhibit all sPLA2 isomers without disrupting cytoplasmic phospholipase A2 (cPLA2), a crucial homeostatic enzyme within cells. MFAIDs also enrich cell surface glycosaminoglycans, protecting cells from exposure to oxygen radicals and certain cytokines.
About Celsus Therapeutics Plc
Celsus Therapeutics is an emerging clinical stage company focused on the development of a new class of non-steroidal, synthetic anti-inflammatory drugs termed Multi-Functional Anti-Inflammatory Drugs or MFAIDs. Celsus's MFAIDs represent a new therapeutic platform for the treatment of a broad array of inflammatory diseases, such as allergies and autoimmune diseases. Presently, the Company's lead drug candidate in its clinical pipeline is MRX-6, an MFAID topical cream treatment under development for treating skin inflammatory disorders, specifically allergic contact dermatitis and atopic dermatitis, also known as eczema. Other potential treatments in preclinical development include OPX-1 for ocular inflammation, CFX-1 for cystic fibrosis, and MRX-5 for inflammatory bowel disease.
FORWARD-LOOKING STATEMENTS – This press release contains "forward-looking statements" that involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," "hope," "look forward" and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Our most recent Annual Report on Form 20-F discusses some of the important risk factors that may affect our business, results of operations and financial condition. Unless we are required to do so under applicable laws, we do not intend to update or revise any forward-looking statements.