Loxo Oncology Announces Third Quarter 2016 Financial Results

- Updated LOXO-101 Phase 1 Clinical Data Accepted for Oral Presentation at ESMO Asia on December 18, 2016 -

- Company to Provide LOXO-101 Program and Pipeline Update During Conference Call and Webcast on Monday, December 19, 2016 at 8:00AM ET -

STAMFORD, Conn., Nov. 02, 2016 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today reported financial results for the third quarter ended September 30, 2016. Loxo Oncology will not be conducting a conference call in conjunction with this earnings release.

"Enrollment in the LOXO-101 program and progress in the preclinical pipeline have positioned us well for the remainder of 2016 and 2017," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "In December, we plan to share updated Phase 1 clinical data for LOXO-101 at ESMO Asia. At that time, we will also provide a comprehensive program update that integrates trial enrollment progress with written regulatory feedback to provide increased visibility into the commercial timelines for LOXO-101. Additionally, we look forward to starting Phase 1 studies in 2017 for named candidates LOXO-292 and LOXO-195."

Upcoming Milestones

LOXO-101
  • Updated clinical data from the adult Phase 1 trial of LOXO-101 have been accepted for an oral presentation at the European Society for Medical Oncology (ESMO) Asia Congress, taking place December 16-19, 2016 in Singapore. The presentation is titled, "Clinical safety and activity from a phase 1 study of LOXO-101, a selective TRKA/B/C inhibitor, in solid-tumor patients with NTRK gene fusions" and will take place at 4:30PM SGT on Sunday, December 18, 2016.
  • In conjunction with ESMO Asia, Loxo Oncology will be hosting a conference call and webcast on December 19, 2016 at 8:00AM ET. Dial-in instructions and webcast information will be posted to the Loxo Oncology website. During this call, Loxo Oncology will review the updated LOXO-101 Phase 1 data and provide an overview of its clinical development plans across the company's portfolio of investigational medicines. The LOXO-101 program update is expected to include:
    • Current enrollment as "percent to goal"
    • Expected timing of full enrollment relative to goal
    • Expected timing of NDA/MAA filings and label potential
  • Preclinical data for LOXO-101 have been accepted for an oral presentation at the 58 th American Society of Hematology (ASH) Annual Meeting, taking place December 3-6, 2016 in San Diego. The presentation is titled, "Genetic Modeling and Therapeutic Targeting of ETV6-NTRK3 with LOXO-101 in Acute Lymphoblastic Leukemia" and will take place at 7:45AM PT on Sunday, December 4, 2016.

Preclinical Programs
  • Preclinical data for Loxo Oncology's RET program (LOXO-292) and TRK acquired resistance program (LOXO-195) have been accepted for presentation at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, taking place November 29 - December 2, 2016 in Munich, Germany.
  • Initiation of a Phase 1 study of LOXO-292, Loxo Oncology's selective RET inhibitor, is expected in early 2017.
  • Initiation of a Phase 1 study of next-generation TRK inhibitor LOXO-195, addressing previously treated patients with acquired resistance, is expected in 2017.

Third Quarter 2016 Financial Results

As of September 30, 2016, Loxo Oncology had aggregate cash, cash equivalents and investments of $156.5 million, compared to $153.9 million as of December 31, 2015.

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