On May 1, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported company highlights and financial results for the first quarter ended March 31, 2017 (Press release, Ignyta, MAY 1, 2017, View Source [SID1234518768]). The company is issuing this press release in lieu of conducting a conference call. Schedule your 30 min Free 1stOncology Demo! "We are excited by the continued advancement of our pipeline of precision medicine therapies for the benefit of patients with cancer, including the progress of STARTRK-2, the registration-enabling Phase 2 clinical trial of our lead product candidate, entrectinib, our novel, investigational, orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1, or ALK fusions," said Jonathan Lim, M.D., Chairman and CEO of Ignyta.
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Company Highlights
Updated Progress Towards Entrectinib Dual TRK and ROS1 NDA Submissions
In April 2016, we announced a comprehensive program update on entrectinib and the STARTRK-2 trial. As of that update:
Entrectinib program is more than 85% enrolled to goal for the primary efficacy analysis to potentially support a TRK tissue agnostic NDA submission
More than 50 patients with ROS1 fusion-positive NSCLC were enrolled; interim data from 32 of these patients as assessed by investigator demonstrated 75% (24 of 32) confirmed RECIST ORR and 17.2 months DOR
Entrectinib demonstrated a confirmed RECIST ORR of 64% (7 of 11) in ROS1 NSCLC patients with CNS metastases
The program is tracking towards dual NDA submissions in TRK and ROS1 in 2018 if supported by clinical data, with anticipated US commercial launch in both indications in 2019.
Multiple Entrectinib Peer-Reviewed Publications
In March 2017, a case report on the successful treatment with entrectinib of a clinical trial patient with a primary brain tumor harboring an NTRK1 fusion was published in the peer-reviewed journal, Precision Oncology. The genomic analysis study, led by researchers at Massachusetts General Hospital, reported three NTRK fusions out of 26 tumors evaluated, and reported that in a patient with a BCAN-NTRK1 fusion, clinical trial treatment with entrectinib resulted in a 60 percent regression in tumor size and a resolution of clinical symptoms that was maintained for 11 months on treatment.
In February 2017, updated results from two Phase 1 trials of entrectinib were published in the peer-reviewed journal, Cancer Discovery. We believe this is the largest published safety experience of any TRK inhibitor in clinical development. Highlights of that publication included:
Findings that entrectinib continues to be well tolerated
As of September 2016 data cutoff, RECIST responses were noted in 3 of 3 patients with TRK-positive extracranial solid tumors, with the longest ongoing TRK responder on therapy for 17 months; and RECIST responses in 12 of 14 patients with ROS1-positive solid tumors, with the longest ongoing ROS1 responder on therapy for 32 months
RECIST responses were noted in 63% of patients (5 out of 8) with TRK, ROS1, or ALK fusions, and primary or metastatic disease involving the brain
Amendment of Lilly Agreement
In March 2017, the company announced that it was exploring strategic options for taladegib – an orally bioavailable small molecule hedgehog/smoothened inhibitor – and had entered into an amended and restated license, development and commercialization agreement with Eli Lilly and Company for the taladegib oncology program.
First Quarter 2017 Financial Results
For the first quarter of 2017, net loss was $40.2 million, or $0.96 per share, compared with $25.5 million, or $0.79 per share, for the first quarter of 2016. The vast majority of the increase was due to $12.8 million ($9.8 million of which was non-cash) recorded in 2017 in connection with the amendment of the Lilly license. This amount represents the remaining $12.0 million of timing-based milestones owed over the subsequent three calendar years, discounted back to today’s cash value, and booked as a largely non-cash expense.
Ignyta did not record any revenue for the first quarter of 2017, or for the first quarter of 2016.
Research and development expenses for the first quarter of 2017 were $34.0 million, compared with $19.8 million for the first quarter of 2016. This increase was due to the $12.8 million charge recorded in 2017 in connection with the Lilly license amendment and increased facilities costs of $1.2 million due to the expansion of our leased facilities space. We also incurred additional stock compensation costs of $0.2 million due to the increase in the number of outstanding stock options.
General and administrative expenses were $5.6 million for first quarter of 2017, compared with $5.2 million for first quarter of 2016. The increase in general and administrative expenses was primarily attributable to an increase in our facilities costs.
At March 31, 2017, the company had cash, cash equivalents and available-for-sale securities totaling $108.0 million and current and long-term debt of $32.0 million. At December 31, 2016, the company had cash, cash equivalents and available-for-sale securities totaling $133.0 million and current and long-term debt of $32.0 million. Excluding a $3.0 million milestone payment related to the Lilly license, cash burn in the quarter was $22.0 million.