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La Jolla Pharmaceutical Company Announces Third Quarter 2015

The following excerpt is from the company's SEC filing.

Financial Results and Recent Corporate Progress


La Jolla Pharmaceutical Company

(NASDAQ: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today reported third quarter 2015 financial results and highlighted recent corporate progress.

La Jolla initiated a Phase 1 clinical trial of LJPC-401, the Company’s novel formulation of hepcidin, in patients at risk of iron overload due to conditions such as hereditary hemochrom atosis, beta thalassemia and sickle cell disease. Preliminary results from this clinical trial are anticipated by the end of 2015.

La Jolla received a positive opinion from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), which the European Commission subsequently adopted, for designation of LJPC-401 as an orphan medicinal product for the treatment of beta thalassemia intermedia and major.

La Jolla and Vanderbilt University entered into an exclusive, worldwide research and license agreement covering Vanderbilt’s research program and intellectual property rights relating to small-molecule kinase inhibitors designed to selectively block specific members of the bone morphogenetic protein (BMP) type-I receptor family, for the potential treatment of fibrodysplasia ossificans progressiva (FOP), acquired heterotopic ossification, muscular dystrophies including Duchenne muscular dystrophy, anemia of chronic disease, cancer, cardiovascular diseases and inflammatory bowel disease.

La Jolla received orphan drug designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development on two novel compounds, which were licensed from Vanderbilt University, for FOP.

La Jolla completed an underwritten public offering of approximately 2.9 million shares of common stock, which includes the full exercise of the underwriters’ overallotment option, at a public offering price of $38.00 per share. The Company received total net proceeds of approximately $104.6 million from this offering.

“The second half of 2015 is off to an exciting and productive start for La Jolla, highlighted by the initiation of our Phase 1 clinical trial for LJPC-401, continued progress with our Phase 3 clinical trial of LJPC-501, the receipt of a positive opinion for designation of LJPC-401 as an orphan medicinal product in Europe and the receipt of orphan drug designation for two of the recently licensed compounds from Vanderbilt in the U.S.,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “We look forward to building on this momentum, with the anticipation of preliminary results from the LJPC-401 Phase 1 clinical trial by the end of this year and results from the LJPC-501 Phase 3 clinical trial by the end of 2016.”

Results of Operations

As of September 30, 2015, La Jolla had $135.1 million in cash and cash equivalents, compared to $48.6 million as of...