On March 14, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported company highlights and financial results for the full year ended December 31, 2016 (Press release, Ignyta, MAR 14, 2017, View Source [SID1234518168]). The company is issuing this press release in lieu of conducting a conference call.
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"In 2016, we continued to advance our pipeline of molecularly targeted therapies for the benefit of patients with cancer, including the STARTRK-2 registration-enabling Phase 2 clinical trial of our lead product candidate, entrectinib, our CNS-active tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We demonstrated robust clinical proof-of-concept data for entrectinib, as well as RXDX-105—our investigational, VEGFR-sparing, potent RET inhibitor—and made significant preclinical progress on RXDX-106, which represents a novel class of immunomodulatory agents that appears to restore innate immunity in preclinical models via potent inhibition of the TYRO3, AXL and MER (or TAM) family of receptors. Furthermore, in 2016, our in-house Trailblaze Pharos diagnostic assay achieved multiple regulatory milestones, we bolstered our balance sheet, and strengthened our leadership team."
Company Highlights
Entrectinib Clinical Progress
In February 2017, the company announced that updated results from two Phase 1 trials of entrectinib were published in the peer-reviewed journal, Cancer Discovery. Highlights of that publication included that entrectinib has the largest published safety experience of any TRK inhibitor in clinical development and continues to be well tolerated. As of the September 2016 data cutoff, RECIST responses were noted in three of three 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 32.2 months. Within the subset of 13 patients with ROS1-positive non-small cell lung cancer (NSCLC), the response rate was 85% with a median duration of response of 17.3 months. Additionally, RECIST responses were noted in 63% of patients (five out of eight) with primary or metastatic disease involving the brain.
RXDX-105 Clinical Progress
In November 2016, Ignyta announced interim results from the ongoing Phase 1/1b clinical study of RXDX-105, which were presented at the 2016 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium on Molecular Targets and Cancer Therapeutics in Munich, Germany.
Those results highlighted RXDX-105’s clinical activity in patients harboring RET molecular alterations, with five out of nine patients with RET fusion-positive cancers who were RET inhibitor-naïve achieving a RECIST response (one complete response, three partial responses, and one unconfirmed partial response), for a preliminary objective response rate (ORR) of 56%. Within the subset of seven patients with RET fusion-positive NSCLC, four responded, for a preliminary ORR of 57%.
RXDX-106 Preclinical Progress
In November 2016, preclinical data on RXDX-106 were presented at the 2016 ENA Symposium highlighting immuno-oncological and direct tumor-inhibiting activity of this novel agent via potent inhibition of its targets. Those data showed that RXDX-106 is a potent inhibitor of TAM and c-MET targets, and inhibited TAM-mediated and c-MET-mediated tumor growth in vivo. Also, via in vitro and in vivo studies, RXDX-106, as a single agent, appears to release the molecular brakes on immune activation in macrophages, NK cells, and T cells, resulting in the repolarization of the immune response to elicit an anti-tumor effect; and emerging in vivo combination data suggest that RXDX-106 potentiates the activity of anti-PD-1 and anti-CTLA-4 agents.
Diagnostics Laboratory
In November 2016, the company announced that it has received Expedited Access Pathway (EAP) designation from the U.S. Food and Drug Administration (FDA) and also "European Conformity" (CE) marking for its Trailblaze Pharos companion diagnostic test service. The EAP designation enables Ignyta and FDA to have more interactive discussions of the premarket approval application (PMA) for Trailblaze Pharos, which is the proposed companion diagnostic for entrectinib. In August 2016, the FDA approved an investigational device exemption (IDE) for Trailblaze Pharos.
Financing Transactions
In June 2016, the company secured a $42 million term loan facility from Silicon Valley Bank and Oxford Finance. Under the loan facility, the company received initial funding of $32 million, substantially all of which was used to repay the company’s prior loan with Silicon Valley Bank, and has a conditional option to receive an additional $10 million.
In May 2016, the company issued an aggregate of 9.2 million shares of its common stock in an underwritten public offering at a purchase price of $6.25 per share, which resulted in aggregate gross proceeds of $57.5 million.
Financial Results
For the 2016 fiscal year, net loss was $103.6 million, or $2.69 per share, compared with $92.5 million, or $3.44 per share, for the 2015 fiscal year.
Ignyta had no revenues during 2016 or 2015.
Research and development expenses for 2016 were $76.9 million, compared with $73.5 million for 2015. During 2015, the company incurred total costs of $28.2 million in connection with its acquisition of rights to development programs from Teva and Lilly, consisting of the combined $25.3 million net value of our common stock issued and combined upfront payments totaling $2.9 million made to Teva and Lilly in connection with these transactions. Excluding these costs, R&D costs increased by $31.6 million, or 70%, during 2016 as compared to the same period in 2015. This increase was due to the $20.7 million increase in the chemistry, manufacturing, and control and external clinical development costs associated with entrectinib and the company’s other product candidates, and increased facilities costs due to an expansion of its leased facilities space. Additionally, the company incurred increased personnel costs, including additional stock compensation costs of $0.9 million, due to an increase in R&D personnel.
General and administrative expenses were $23.8 million for 2016, compared with $17.1 million for 2015. The increase was primarily attributable to increases in personnel costs, including additional stock compensation costs of $1.5 million.
At December 31, 2016, the company had cash, cash equivalents, and investment securities totaling $133.0 million and current and long-term debt of $32.0 million. At December 31, 2015, the company had cash, cash equivalents, and investment securities totaling $172.1 million and current and long-term debt of $31.0 million.