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TetraLogic Reports 2014 Financial Results and Provides Clinical Programs Update
February 26, 2015 16:10 ET | Source: TetraLogic Pharmaceuticals
MALVERN, Pa., Feb. 26, 2015 (GLOBE NEWSWIRE) -- TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG), a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, today announced financial results for the year ended December 31, 2014. These results are included in TetraLogic's Annual Report on Form 10-K which has been filed with the Securities and Exchange Commission.
"The TetraLogic team achieved several significant milestones in 2014," said J. Kevin Buchi, President and Chief Executive Officer of TetraLogic. "We advanced birinapant into two randomized Phase 2 trials; we also acquired a second asset, SHAPE, and commenced a randomized Phase 2 trial with that molecule as well."
Summary of Key Development Programs, Updates and Anticipated Milestones
Birinapant HBV Program: Based upon preclinical assays in which birinapant-treated mice demonstrated clearance of hepatitis B surface antigen (HBsAg) and the formation of antibodies to HBsAg, we have commenced enrollment in a multiple ascending dose clinical trial of birinapant in subjects with chronic hepatitis B. The trial is being conducted in subjects over the age of 18 with hepatitis B who are receiving treatment with either tenofovir or entecavir and who are HBsAg positive. The trial is expected to enroll approximately 6 cohorts of 8 subjects each, who will receive 4 weekly treatments with either birinapant or placebo in a 3:1 ratio. The study is being conducted at multiple clinical sites in Australia. Although predominantly a safety and tolerability study, patients are being monitored for reductions in HBsAg and the formation of antibodies to HBsAg, as indications of therapeutic activity.
Birinapant MDS Program: In May 2014, we announced that, based upon data from our Phase 1b study of birinapant in combination with azacitidine in patients with higher risk MDS who are either relapsed/refractory or naïve to azacitidine, we initiated a randomized Phase 2 clinical trial in first line higher risk MDS patients. While the primary objective of the Phase 1b clinical study was to characterize the safety and tolerability and determine the recommended Phase 2 dose of birinapant when administered in combination with azacitidine, we did observe bone marrow responses in a number of patients who had relapsed or were refractory to azacitidine.
SHAPE CTCL Program: In April 2014, we acquired Shape Pharmaceuticals, Inc. In May 2014, safety and efficacy data from the Phase 1b randomized placebo controlled clinical study of SHAPE, our topical HDAC inhibitor, in Stage IA –IIA Cutaneous T-cell Lymphoma (CTCL) were presented at the annual Society of Investigative Dermatology meeting and at American Society of Clinical Oncology meeting. In December 2014, we commenced a randomized Phase 2 clinical trial of SHAPE in early stage CTCL.
Birinapant/conatumumab Program: We are continuing enrollment in a Phase 1/2 study of birinapant in combination with conatumumab, Amgen's TRAIL agonist antibody, in 3rd line ovarian cancer. In December 2014 this clinical trial proceeded into a Phase 2a expansion based upon data in the Phase 1 portion of the trial.
We expect data from all studies to be available in 2015, making this an important year for TetraLogic.
Full Year 2014 Financial Highlights
Cash, cash equivalents, and marketable securities totaled $53.7 million at December 31, 2014, as compared to $55.1 million at December 31, 2013.
Research and Development expenses were $19.4 million in 2014, excluding $0.9 million in non-cash, stock based compensation expense, compared to $8.6 million in 2013, excluding $0.9 million in non-cash, stock based compensation expense. The increase primarily results from additional costs associated with clinical trials, including the manufacturing and formulation of our clinical drug supplies.
General and Administrative expenses were $8.5 million in 2014, excluding $2.5 million in non-cash, stock based compensation expense, compared to $5.6 million in 2013, excluding $2.8 million in non-cash, stock based compensation expense.
Adjusted net loss for 2014 was $29.7 million, compared to an adjusted net loss of $17.0 million in 2013. Adjusted net loss excludes (i) non-cash stock based compensation expense; (ii) non-cash interest expense; (iii) non-cash fair value adjustments to the company's derivative liabilities; and (iv) non-cash fair value adjustments to the contingent consideration liability recognized as part of the Shape acquisition in April 2014.
Shares issued and outstanding as of December 31, 2014 were 22.3 million, not including outstanding stock options to purchase 3.3 million shares and 7.0 million shares underlying the company's outstanding convertible notes.
- See more at: http://globenewswire.com/news-re ... thash.ZO9xWxqJ.dpuf
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发表于 2015-2-27 15:07
