Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the second quarter ended June 30, 2015 and provided an overview of key milestones for the company's lead drug candidates.
Earlier this week, Lexicon announced that its most advanced drug candidate, telotristat etiprate, achieved statistically significant results in treating carcinoid syndrome in cancer patients whose condition is not adequately controlled with the standard of care, meeting the pivotal Phase 3 study's primary endpoint.
"We are very pleased with these top-line results and are committed to bringing this innovative treatment to cancer patients impacted by this severe, chronic and life-limiting condition," said Lexicon President and Chief Executive Officer Lonnel Coats. "These results support our plan to work closely with the FDA to expeditiously file our first new drug application."
Pipeline Progress
Lexicon is applying its gene science, based on Nobel Prize winning technology, to discover and advance promising targeted drug candidates through pre-clinical and clinical development. Lexicon is focused on its most advanced drug candidates: telotristat etiprate for carcinoid syndrome, a rare condition that impacts thousands of cancer patients with metastatic neuroendocrine tumors, and sotagliflozin for type 1 diabetes.
Telotristat etiprate is the first investigational drug in clinical studies to target tryptophan hydroxylase (TPH), an enzyme that triggers the excess serotonin production within metastatic neuroendocrine tumor cells that leads to carcinoid syndrome, a condition characterized by debilitating diarrhea, facial flushing, abdominal pain, heart valve damage and other serious consequences.
Top-line results from Lexicon's Phase 3 TELESTAR study show that patients who added telotristat etiprate to the standard of care at both the 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period (p<0.001), meeting the study's primary endpoint.
Telotristat etiprate has received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration (FDA). If approved, telotristat etiprate would be the first oral treatment successfully developed for carcinoid syndrome and the first addition to the standard of care in more than 16 years.1
Sotagliflozin is a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2) currently being studied in type 1 diabetes. Sotagliflozin is the first investigational medicine to target both of these two proteins which are responsible for glucose regulation and has been shown in a Phase 2 study to improve glycemic control in people with type 1 diabetes while at the same time reducing their need for mealtime insulin.
Lexicon has begun enrollment in both of its pivotal Phase 3 clinical trials of sotagliflozin. In parallel with Phase 3 development, Lexicon is also conducting a Phase 2 clinical trial in collaboration with JDRF that focuses on young adults with type 1 diabetes and high A1C, a measure of elevated blood glucose levels.
Financial Highlights
Revenues: Lexicon's revenues for the three months ended June 30, 2015 decreased to $0.4 million from $0.7 million for the corresponding period in 2014, and for the six months ended June 30, 2015 increased to $2.2 million from $1.0 million for the corresponding period in 2014.
Research and Development Expenses: Research and development expenses for the three months ended June 30, 2015 decreased two percent to $20.8 million from $21.2 million for the corresponding period in 2014. For the six months ended June 30, 2015, research and development expenses decreased eight percent to $41.6 million from $45.1 million for the corresponding period in 2014.
Change in Fair Value of Symphony Icon Purchase Liability: In connection with the acquisition of Symphony Icon, Lexicon made an initial estimate of the fair value of the liability for the associated base and contingent payments. Changes in this liability, based on the development of the programs and the time until such payments are expected to be made, are recorded in Lexicon's consolidated statements of operations. The change in fair value of the Symphony Icon purchase liability was ($12,000) and $0.4 million for the three months ended June 30, 2015 and 2014, respectively, and was $1.7 million and $1.6 million for the six months ended June 30, 2015 and 2014, respectively.
General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2015 increased 22 percent to $6.3 million from $5.2 million for the corresponding period in 2014, primarily due to increased consulting costs in preparation for commercialization of telotristat etiprate. For the six months ended June 30, 2015, general and administrative expenses increased 11 percent to $12.0 million from $10.8 million for the corresponding period in 2014.
Consolidated Net Loss: Net loss for the three months ended June 20, 2015 was $28.1 million, or $0.27 per share, compared to a net loss of $26.0 million, or $0.35 per share, in the corresponding period in 2014. Net loss for the six months ended June 30, 2015 was $56.2 million, or $0.54 per share, compared to a net loss of $56.9 million, or $0.77 per share, in the corresponding period in 2014. For the three and six months ended June 30, 2015, net loss included non-cash, stock-based compensation expense of $1.8 million and $3.7 million, respectively. For the three and six months ended June 30, 2014, net loss included non-cash, stock-based compensation expense of $1.8 million and $4.1 million, respectively.
Cash and Investments: As of June 30, 2015, Lexicon had $282.5 million in cash and investments, as compared to $315.1 million as of March 31, 2015 and $339.3 million as of December 31, 2014.
Reverse Stock Split: In May 2015, Lexicon completed a one-for-seven reverse stock split. All references to common shares and per-share data for all periods presented in this release have been adjusted to give effect to this reverse stock split.
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