TRACON Pharmaceuticals Reports Third Quarter 2016 Financial Results And Provides Corporate Update

Strategic Licensing Collaboration with Janssen Expanded TRACON's Oncology Portfolio and Validated Company's Unique Clinical Development Capabilities

Key Elements of Initial Phase 3 Trial of TRC105 Confirmed Through Discussions with U.S. FDA and European Regulatory Agencies

SAN DIEGO, Nov. 08, 2016 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, today announced financial results for the third quarter ended September 30, 2016, and provided an update on recent corporate events.

Third Quarter 2016 and Recent Corporate Highlights
  • Entered into a strategic licensing collaboration with Janssen Pharmaceutica N.V. (Janssen) for two novel oncology assets from Janssen's early development portfolio. TRC253, intended for the treatment of men with prostate cancer, is a Phase 1/2 ready novel small molecule high affinity competitive inhibitor of wild type androgen receptor (AR) and multiple AR mutant receptors that may display drug resistance to Xtandi ® (enzalutamide). TRC694, intended for the treatment of patients with hematologic malignancies, including myeloma, is a pre-clinical asset that is a potent, oral inhibitor of NF-kB inducing kinase (NIK). 
  • Concurrent with the strategic licensing collaboration, Johnson & Johnson Innovation - JJDC, Inc. (JJDC) completed a $5.0 million equity investment in TRACON through the purchase of 840,022 shares of common stock at $5.95 per share determined by the average of the daily volume weighted average closing prices of the common stock as reported on NASDAQ for the five days prior to the date of the purchase. 
  • Announced the successful completion of an End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) and a Protocol Assistance Meeting with the European Medicines Agency (EMA). TRACON reached agreement with both regulatory agencies regarding key elements of the Phase 3 program for TRC105 in angiosarcoma and expects to initiate the Phase 3 study by year-end, following an expected special protocol assessment (SPA) agreement with the FDA. 
  • Reported updated results from a Phase 1b clinical trial combining TRC105 with Inlyta ® (axitinib) in patients with advanced or metastatic renal cell carcinoma (RCC) at the European Society for Medical Oncology (ESMO) 2016 Congress. Median progression free survival (PFS) of 11.3 months was observed in all RCC patients in the study, including those patients with clear cell RCC, the most prevalent form of RCC. An objective response rate (ORR) of 29% was also seen in the trial. For comparative purposes, median PFS observed in the large subgroup of VEGFR TKI-refractory patients treated with Inlyta (n=194) in the Inlyta AXIS Phase 3 study in second line clear cell RCC patients (a separate trial) was 4.8 months and the ORR was 11.3%. 
  • Initiated dosing in a global Phase 2 trial of TRC105 in patients with gestational trophoblastic neoplasia, or GTN (including choriocarcinoma). The primary endpoint of the trial is response rate and TRACON expects to enroll a total of 30 patients.

"During the third quarter, we accomplished a number of key value-creating milestones that have significantly strengthened our product development efforts," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "The Janssen licensing deal expands our portfolio of potential first-in-class oncology therapies and provides validation of our unique product development platform. Additionally, our positive interactions with both U.S. and European regulators enabled us to establish the key elements of our initial Phase 3 pivotal study for TRC105, which we look forward to initiating in December 2016 or early 2017."

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