On May 14, 2015 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the discovery, development, and commercialization of targeted cancer therapies, reported first quarter 2015 financial results and recent business highlights.
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"In the first quarter of 2015 we demonstrated strong progress in our pipeline, including the presentation of initial clinical data for LOXO-101 at AACR (Free AACR Whitepaper) and the unveiling of three additional preclinical programs. Our focus on targeted cancer therapies with best-in-class potential reflects our belief that selective, rationally designed drugs can demonstrate clinical benefit and differentiation when tested in patients with the relevant oncogene addicted tumors," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "We are pleased that initial data from our Phase 1a trial of LOXO-101 show that the drug is achieving biologically relevant exposures, while revealing no clear drug-related safety signals. We look forward to moving into exclusively TRK-altered patients in the second half of the year and continuing to advance our pipeline."
Recent Business Highlights
Presented Initial Phase 1a Data for LOXO-101 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
In April, the Company presented initial Phase 1a safety and pharmacokinetic data for LOXO-101 in a poster session at the AACR (Free AACR Whitepaper) 2015 Annual Meeting in Philadelphia. Key findings from the poster presentation included:
As of the data cut-off for the poster, March 26, 2015, 15 patients had been enrolled across three dose cohorts: 50mg QD (n=4), 100mg QD (n=5), and 100mg BID (n=6), including one soft tissue sarcoma patient with an NTRK1 fusion enrolled on March 10, 2015
Pharmacokinetics showed good systemic exposure of LOXO-101 after oral dosing, with higher exposures observed than those predicted in nonclinical studies
LOXO-101 was generally well tolerated, with the most common adverse events being Grade 1 and 2 fatigue, dizziness and anemia; no study drug related serious adverse events (SAEs) were reported; the maximum tolerated dose (MTD) had not yet been reached.
Updated Program Guidance for 2015
On March 2, 2015, the Company updated its 2015 program guidance, unveiling molecular targets for three of its seven active preclinical programs. The three targets disclosed were Rearranged during Transfection (RET), Fibroblast Growth Factor Receptor (FGFR), and FMS-Like Tyrosine kinase 3 (FLT3). In addition to these three programs, Loxo possesses well-vetted candidates for two other programs, not yet disclosed by target name, which are ready for IND-enabling work. All of the Company’s current preclinical pipeline programs are being pursued as part of Loxo’s collaboration with Array BioPharma. The Company will provide periodic data updates for its discovery pipeline at medical meetings, beginning in the second half of 2015.
Appointed New Vice President of Finance, Jennifer Burstein, CPA
In early May, Loxo appointed Ms. Jennifer Burstein, CPA, as vice president of finance. Jennifer will be the Company’s principal financial officer and principal accounting officer. Prior to Loxo, Ms. Burstein served as vice president of finance at Acorda Therapeutics, Inc., a public biotechnology company, from July 2010 until April 2015, where she held several positions of increasing responsibility in finance from 2006 until being appointed vice president of finance. Prior to joining Acorda, from 2002 to 2006, she was with Eyetech Pharmaceuticals, Inc., a public biotechnology company, which is currently a subsidiary of Valeant Pharmaceuticals International, Inc., where she held several positions of increasing responsibility in finance until being promoted to senior director, accounting. Before Eyetech, Ms. Burstein worked in the finance departments at several companies and in public accounting. Ms. Burstein received her B.S. in business administration and M.B.A. in accounting from the State University of New York at Buffalo and has a CPA license in New York.
Upcoming Poster Presentations at ASCO (Free ASCO Whitepaper) Annual Meeting
Loxo reported it will present two posters at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, Illinois on May 29-June 2, 2015. Loxo will not be presenting new clinical data at this meeting.
The details of the poster sessions are as follows:
Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Date: Saturday, May 30
Poster Viewing Session: 8:00 – 11:30a.m. CDT
Location: S Hall A
Poster Number: 328b
Title: A first-in-human study of LOXO-101, a highly selective inhibitor of the tropomyosin receptor kinase (TRK) family. (Abstract # TPS2624, Trials in Progress)
Lead Author: Howard A. Burris, M.D.
Poster Session: Cancer Prevention, Genetics, and Epidemiology
Date: Monday, June 1
Poster Viewing Session: 1:15-4:45p.m. CDT
Location: S Hall A
Poster Number: 377
Title: Identification of tropomyosin kinase receptor (TRK) mutations in cancer. (Abstract # 1553)
Lead Author: Nisha Nanda, Ph.D.
First Quarter 2015 Financial Results
As of March 31, 2015 Loxo had aggregate cash, cash equivalents and investments of $107.6 million, compared to $112.9 million as of December 31, 2014.
The Company continues to expect cash burn of $30-$33 million in 2015, and based on the current operating plan, the Company believes existing capital resources will be sufficient to fund anticipated operations into 2017.
Research and development expenses were $3.8 million for the first quarter of 2015 compared to $2.0 million in the first quarter of 2014. This increase of $1.8 million was primarily due to expanded clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma. The Company also recognized stock-based compensation expense of $0.5 million during the first quarter of 2015 compared to $40,000 for the first quarter of 2014.
General and administrative expenses were $2.4 million for the first quarter of 2015 compared to $0.9 million in the first quarter of 2014. The increase of $1.5 million was primarily due to increased costs associated with operating as a public company. The Company also recognized stock-based compensation expense of $0.6 million during the first quarter 2015 compared to $20,000 for the first quarter 2014.
Net loss attributable to common shareholders was $6.2 million and $2.9 million for the first quarters 2015 and 2014, respectively.
The Company will not be conducting a conference call in conjunction with this earnings release. Loxo plans to continue its tradition of conducting an earnings conference call in conjunction with its fourth quarter earnings releases.