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MALVERN, Pa., Nov. 4, 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 third quarter ended September 30, 2015. These results are included in TetraLogic's Quarterly Report on Form 10-Q which has been filed with the Securities and Exchange Commission.
Summary of Key Development Programs, Updates and Anticipated Milestones
Birinapant MDS Program: In June 2015, we announced encouraging preliminary data from the ongoing Phase 2a portion of our study of birinapant in combination with azacitidine in first line higher risk myelodysplastic syndromes (MDS). Enrollment continues in the Phase 2b portion of this randomized Phase 2 clinical trial in first line higher risk MDS patients and we expect interim data in early January 2016.
SHAPE CTCL Program: We have achieved our enrollment target in our randomized Phase 2 clinical trial of SHAPE, a topical HDAC inhibitor, in early stage Cutaneous T-cell Lymphoma (CTCL). We expect data in early January 2016.
Birinapant/KEYTRUDA® Program: In April 2015, TetraLogic and Merck announced that the companies would collaborate on a Phase 1 study to evaluate the safety and efficacy of birinapant in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with relapsed or refractory solid tumors. The study is expected to begin in December 2015.
Birinapant HBV Program: As a follow-on to our discontinued multiple ascending dose study, in July 2015, we announced that we intend to re-initiate a program in HBV and conduct a combination single ascending dose/multiple ascending dose clinical trial, with birinapant as a single agent, in chronic HBV subjects who are naïve to antiviral medication. We have retained a clinical research organization to initiate this trial at multiple sites in India in the first half of 2016. The application to commence the clinical trial is currently under review by the Indian regulatory authority. Timing of results will depend upon receiving approval to proceed, enrollment rates and the cohort in which activity, if any, is seen.
SHAPE Alopecia Areata Program: On November 2, 2015, we announced that we have an open U.S. Investigational New Drug application in support of a Phase 2 clinical trial of SHAPE in patients with alopecia areata. The Phase 2 trial will be conducted in approximately forty patients.
Third Quarter 2015 Financial Highlights
Cash, cash equivalents, and marketable securities totaled $29.5 million at September 30, 2015, as compared to $53.7 million at December 31, 2014.
Research and Development expenses were $5.7 million for the third quarter of 2015, excluding $0.4 million in non-cash, stock based compensation expense, compared to $5.7 million for the same period in 2014, excluding $0.2 million in non-cash, stock-based compensation expense. Increases in spending on our MDS Phase 2 and SHAPE CTCL Phase 2 clinical trials were offset by decreases in spending on our ovarian and HBV clinical trials.
General and Administrative expenses were $1.5 million for the third quarter of 2015, excluding $1.0 million in non-cash, stock-based compensation expense, compared to $2.0 million for the same period in 2014, excluding $0.6 million in non-cash, stock based compensation expense. This decrease primarily results from decreases in legal, personnel, and investor relations costs.
Adjusted net loss for the third quarter of 2015 was $8.1 million, compared to an adjusted net loss of $8.6 million for the same period in 2014. 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 September 30, 2015 were 24.8 million, not including outstanding stock options to purchase 4.0 million shares and 6.5 million shares underlying the Company's outstanding convertible notes. This includes 1.4 million shares issued during the quarter under a purchase agreement with Lincoln Park Capital Fund, LLC for gross proceeds of $2.9 million.
- See more at: http://globenewswire.com/news-re ... thash.v3hxbFgY.dpuf
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发表于 2015-11-6 10:01
