Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company
focused on precision medicine in oncology, today announced company
highlights and financial results for the second quarter ended June
30, 2017. The company is issuing this press release in lieu of
conducting a conference call.
“During the second quarter, we provided substantial development,
regulatory, and commercial strategy updates for our lead product
candidate, entrectinib, a 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. “In addition, we received breakthrough therapy
designation for entrectinib, presented exciting preclinical
immunomodulation data for RXDX-106, and strengthened our balance
sheet via an equity offering, providing us with the resources to
continue developing meaningful new therapies for patients with
cancer.”
Company Highlights
Updated Progress Towards Entrectinib Dual TRK and ROS1 NDA and
PMA Submissions
In April 2017, we announced a comprehensive program update on
entrectinib and the STARTRK-2 trial. As of that update:
- More than 50 patients with ROS1
fusion-positive non-small cell lung cancer (NSCLC) were enrolled;
interim data from 32 of these patients (as assessed by
investigator) demonstrated 75% confirmed RECIST objective response
rate (ORR) (24 partial or complete responses out of 32) and 17.2
months median duration of response (DOR)
- Entrectinib demonstrated confirmed
RECIST Intracranial ORR (IC-ORR) of 83% (5 partial responses out of
6) in ROS1 NSCLC patients with measurable central nervous system
(CNS) metastases
- The entrectinib program was more than
85% enrolled to goal for the primary efficacy analysis to
potentially support a TRK tissue agnostic NDA submission
The program is tracking towards dual NDA submissions in TRK and
ROS1 in 2018, if supported by clinical data, with anticipated U.S.
commercial launch in both indications in 2019.
Breakthrough Therapy Designation and Orphan Drug Designation for
Entrectinib
In May 2017, the company announced that the U.S. Food and Drug
Administration (FDA) granted a Breakthrough Therapy Designation
(BTD) to entrectinib “for the treatment of NTRK fusion-positive,
locally advanced or metastatic solid tumors in adult and pediatric
patients who have either progressed following prior therapies or
who have no acceptable standard therapies.”
In July 2017, the company announced that FDA granted orphan drug
designation to entrectinib for “treatment of NTRK fusion-positive
solid tumors.”
RXDX-106 AACR Presentations
In April 2017, we presented preclinical data at the Annual
Meeting of the American Association for Cancer Research (AACR) in
Washington D.C. suggesting that RXDX-106 can act as both an
anti-tumor immuno-modulator and TYRO3, AXL and MER (or TAM)
oncodriver inhibitor, potentially supporting clinical development
of RXDX-106 in a wide variety of cancers. RXDX-106 represents a
novel class of immunomodulatory agents that appears to restore
innate immunity in preclinical models via potent inhibition of the
TAM family of receptors.
Financing Transaction
In May 2017, the company issued an aggregate of 14.375 million
shares of its common stock in an underwritten public offering at a
price to the public of $6.15 per share, which resulted in aggregate
gross proceeds of $88.4 million.
Second Quarter 2017 Financial Results
For the second quarter of 2017, net loss was $28.3 million, or
$0.56 per share, compared with $26.7 million, or $0.70 per share,
for the second quarter of 2016.
Ignyta did not record any revenue for the second quarter of
2017, or for the second quarter of 2016.
Research and development expenses for the second quarter of 2017
were $22.2 million, compared with $20.0 million for the second
quarter of 2016. This increase was due to an increase in external
clinical development costs and the chemistry, manufacturing and
control costs associated with entrectinib and our other product
candidates, 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 $0.8 million due in part to
the increase in the number of outstanding stock options.
General and administrative expenses were $5.5 million for the
second quarter of each of 2017 and 2016, respectively. There was no
measurable change in our general and administrative expenses
between the two periods, as the increases in facilities costs and
outside services expenses were offset by a reduction in our
personnel related expenditures.
At June 30, 2017, we had cash, cash equivalents and
available-for-sale securities totaling $169.4 million and current
and long-term debt of $32.0 million. At December 31, 2016, we had
cash, cash equivalents and available-for-sale securities totaling
$133.0 million and current and long-term debt of $32.0 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, and potential timing of regulatory
submissions and commercialization for entrectinib and Ignyta’s
product candidates, Ignyta’s ability to quickly advance potential
treatments, the potential advantages and first-in-class or
best-in-class nature of these drug programs, the impact of
entrectinib breakthrough therapy and orphan drug designations on
Ignyta's interactions with FDA, 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)
(unaudited) Three months ended June 30, Six
months ended June 30, 2017 2016 2017
2016 Operating expenses: Research and
development $ 22,172 $ 20,019 $ 56,218 $ 39,800 General and
administrative 5,496 5,499
11,065 10,726 Total operating expenses
27,668 25,518 67,283
50,526 Loss from operations (27,668 ) (25,518
) (67,283 ) (50,526 )
Other income (expense):
Interest expense (829 ) (800 ) (1,641 ) (1,591 ) Other income
(expense) 219 (332 ) 486
(25 ) Total other expense, net (610 ) (1,132 )
(1,155 ) (1,616 )
Net loss $ (28,278 )
$ (26,650 ) $ (68,438 ) $ (52,142 )
Net loss per common
share: Net loss per share - basic and diluted $ (0.56 ) $ (0.70
) $ (1.49 ) $ (1.48 ) Weighted average shares - basic and diluted
50,062 38,198 45,918
35,271
IGNYTA,
INC. CONDENSED BALANCE SHEETS (in thousands)
June 30, December 31, 2017 2016
(unaudited) ASSETS Cash and cash equivalents $ 61,147
$ 24,340 Short-term investment securities 104,231 83,637 Other
current assets 3,958 3,873
Total current
assets 169,336 111,850 Long-term investment securities 4,000
24,983 Property and equipment, net 4,675 6,270 Other long-term
assets 1,520 1,811
Total assets $ 179,531 $
144,914
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts payable and accrued liabilities $ 17,420 $ 13,510
Obligation due to licensor 3,709 - Accrued compensation and
benefits 2,057 4,007
Total current liabilities
23,186 17,517 Term debt, net 29,838 29,517 Other long-term
liabilities 11,628 3,110
Total liabilities
64,652 50,144 Total stockholders’ equity 114,879 94,770
Total liabilities and stockholders' equity $ 179,531
$ 144,914
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version on businesswire.com: http://www.businesswire.com/news/home/20170808005427/en/
Ignyta, Inc.Jacob Chacko, M.D.CFO858-255-5959jc@ignyta.com
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