Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company
focused on precision medicine in oncology, today announced company
highlights and financial results for the full year ended December
31, 2016. The company is issuing this press release in lieu of
conducting a conference call.
“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 (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.
About Ignyta, Inc.
Blazing a New Future for Patients with
Cancer™
At Ignyta, we work tirelessly on behalf of patients with cancer
to offer potentially life-saving, precisely targeted therapeutics
(Rx) guided by companion diagnostic (Dx) tests. Our integrated
Rx/Dx strategy allows us to enter uncharted territory, illuminating
the molecular drivers of cancer and quickly advancing treatments to
address them. This approach embraces even those patients with the
rarest cancers, who have the highest unmet need and who may
otherwise not have access to effective treatment options. With our
pipeline of potentially first-in-class or best-in-class precision
medicines, we are pursuing the ultimate goal of not just shrinking
tumors, but eradicating cancer relapse and recurrence in precisely
defined patient populations.
For more information, please visit: www.ignyta.com.
Forward-Looking Statements
This press release contains forward-looking
statements about Ignyta as that term is defined in Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Statements in this press release that are not
purely historical are forward-looking statements. Such
forward-looking statements include, among other things, references
to the development of Ignyta’s product candidates, the potential
advantages and first-in-class or best-in-class nature of these drug
programs and the potential for Ignyta to establish a leadership
position in oncology personalized medicine and provide benefit to
cancer patients. Actual results could differ from those projected
in any forward-looking statements due to numerous factors. Such
factors include, among others, the inherent uncertainties
associated with developing new products or technologies and
operating as a development stage company; Ignyta’s ability to
develop, initiate or complete preclinical studies and clinical
trials for, obtain approvals for and commercialize any of its
product candidates; changes in Ignyta’s plans to develop and
commercialize its product candidates; the potential for final
results of the ongoing clinical trials of entrectinib or other
product candidates, or any future clinical trials of entrectinib or
other product candidates, to differ from preliminary or expected
results; Ignyta’s ability to raise any additional funding it will
need to continue to pursue its business and product development
plans; regulatory developments in the United States and foreign
countries; Ignyta’s ability to obtain and maintain intellectual
property protection for its product candidates; the risk that
orphan drug exclusivity may not effectively protect a product from
competition and that such exclusivity may not be maintained; the
potential for the company to fail to maintain the CAP accreditation
and CLIA certification of its diagnostic laboratory; the loss of
key scientific or management personnel; competition in the industry
in which Ignyta operates; and market conditions. These
forward-looking statements are made as of the date of this press
release, and Ignyta assumes no obligation to update the
forward-looking statements, or to update the reasons why actual
results could differ from those projected in the forward-looking
statements. Investors should consult all of the information set
forth herein and should also refer to the risk factor disclosure
set forth in the reports and other documents the company files with
the SEC available at www.sec.gov, including without limitation
Ignyta’s Annual Report on Form 10-K for the year ended December 31,
2016 and subsequent Quarterly Reports on Form 10-Q.
IGNYTA, INC. CONDENSED
STATEMENTS OF OPERATIONS (in thousands, except per share data)
Year ended December 31, 2016 2015
Operating expenses: Research and development $ 76,926 $
73,511 General and administrative 23,758
17,069 Total operating expenses 100,684
90,580 Loss from operations (100,684 ) (90,580
)
Other income (expense): Interest expense (3,214 )
(2,593 ) Other income (expense) 955 715 Loss on debt extinguishment
(696 ) - Total other expense, net
(2,955 ) (1,878 )
Net loss $ (103,639 )
$ (92,458 )
Net loss per common share: Net loss per
share - basic and diluted $ (2.69 ) $ (3.44 ) Weighted average
shares - basic and diluted 38,480 26,854
IGNYTA,
INC. CONDENSED BALANCE SHEETS (in thousands)
December 31, 2016 2015 ASSETS Cash and
cash equivalents $ 24,340 $ 46,383 Short-term investment securities
83,637 85,420 Other current assets 3,873 4,191
Total current assets 111,850 135,994 Long-term investment
securities 24,983 40,346 Property and equipment, net 6,270 18,764
Other long-term assets 1,811 410
Total assets
$ 144,914 $ 195,514
LIABILITIES AND STOCKHOLDERS’
EQUITY Accounts payable and accrued liabilities $ 13,510 $
14,025 Accrued compensation and benefits 4,007 3,844 Current
portion of term debt - 6,675
Total current
liabilities 17,517 24,544 Term debt, net 29,517 22,821 Other
long-term liabilities 3,110 12,164
Total
liabilities 50,144 59,529 Total stockholders’ equity 94,770
135,985
Total liabilities and stockholders'
equity $ 144,914 $ 195,514
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version on businesswire.com: http://www.businesswire.com/news/home/20170314005577/en/
Ignyta, Inc.Jacob Chacko, M.D.CFO858-255-5959jc@ignyta.com
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