LOS ANGELES, Nov. 8, 2017 /PRNewswire/ -- CytRx Corporation
(NASDAQ: CYTR), a biopharmaceutical research and development
company specializing in oncology, today announced financial results
for the quarter ended September 30,
2017, and provided an overview of recent accomplishments and
plans.
"The third quarter of 2017 was transformative for CytRx," said
Steven A. Kriegsman, CytRx's
Chairman and CEO. "We executed a global strategic licensing
transaction for aldoxorubicin, placing this clinically validated,
post-Phase 3 asset into the hands of NantCell, Inc. to file the
planned New Drug Application with the U.S. FDA. Further,
NantCell is laying the groundwork to develop aldoxorubicin in
combination with other anti-cancer agents, including
immunotherapies and other innovative cell-based approaches, and
recently communicated their plans to submit Investigational New
Drug (IND) Applications to the U.S. FDA combining aldoxorubicin
with certain immunotherapy protocols in patients with pancreatic
and breast cancer."
Mr. Kriegsman continued, "Internally, our efforts and resources
have been refocused on generating new candidates from our
proprietary LADR™ (Linker Activated Drug Release) technology
platform where our goal is to create a new class of rationally
designed, breakthrough anti-cancer drugs with the potential to
address a broad range of tumor types. Selection of a highly
potent drug conjugate to bring into the clinic is at the forefront
of our strategy heading into 2018, and we remain opportunistic in
seeking out strategic alliances with big pharma."
Third Quarter 2017 and Recent Highlights
Highlighted Progress of LADR™ Candidates and Future Oncology
Pipeline. In November 2017, CytRx
provided an update on its R&D activities surrounding its
proprietary LADR™ (Linker Activated Drug Release) Technology
Platform. To date in 2017, the Company's drug discovery
laboratory, located in Freiburg, Germany, has tested over 75 rationally
designed drug conjugates, and four lead candidates have been
selected based on in vitro and animal preclinical studies,
stability, and manufacturing feasibility. The Company's goal
is to nominate the next LADR™ candidate for clinical development in
the first quarter of 2018 and to present these important
preclinical data at an upcoming scientific meeting during the first
half of 2018. Additional animal efficacy and toxicology testing of
these lead candidates is underway, and CytRx's goal is to file the
first LADR™-discovered, ultra-high potency conjugate IND for
clinical trials in 2018.
Completed Reverse Stock Split. On November 1, 2017, CytRx completed a 1-for-6
reverse stock split of its issued and outstanding common
stock. The split-adjusted shares of CytRx's common stock will
continue trading on the Nasdaq Capital Market under the Company's
existing symbol "CYTR," provided that the Company continues to
comply with the Nasdaq listing requirements. The reverse
stock split reduced the number of common shares outstanding to
approximately 27.6 million as of the effective date.
Authorized shares were also proportionally reduced to approximately
41.7 million, and the Company's preferred stock was reduced to
approximately 0.8 million shares. The reverse stock split was
approved by the Company's stockholders at a Special Meeting held on
October 27, 2017.
Completed Strategic Realignment of Clinical Development
Team. In November 2017, the
Company announced a strategic realignment of its development team
to focus its efforts on generating new drug candidates from its
LADR™ Technology Platform. Hurley Consulting Associates, who
have been providing strategic consulting to CytRx, will lead the
company's development and regulatory activities. Concurrently, the
position of Senior Vice President of Drug Development has been
eliminated, and Shanta Chawla, M.D.,
has retired.
Announced Upcoming NantCell INDs. In October 2017, CytRx announced that aldoxorubicin
licensee NantCell, Inc. (a private subsidiary of NantWorks, LLC)
plans to submit IND applications combining aldoxorubicin with its
immunotherapy protocols for clinical trials in pancreatic and
breast cancers. The planned clinical trials will enroll
patients with cancers resistant to standard therapy and will employ
adaptive designs allowing for expansion of treatment cohorts and
modification of patient treatments based on tumor profiling and
individual patient responses over time.
Completed Strategic Licensing Transaction with NantCell for
Development of Aldoxorubicin. In July 2017, CytRx and NantCell executed a
strategic licensing agreement for the global rights to
aldoxorubicin. NantCell, led by Dr. Patrick Soon-Shiong, who developed and
commercialized Abraxane®, an albumin-mediated cytotoxic agent,
received exclusive rights to develop and commercialize
aldoxorubicin for all indications. Under the terms of the
agreement, NantCell purchased $13
million of CytRx common stock at a per share price of
$6.60 (split-adjusted), representing
approximately a 92% premium to the market price at the time of the
transaction. CytRx is eligible to receive up to an additional
$343 million in regulatory and
commercial milestones, plus increasing double-digit royalties on
sales for aldoxorubicin's lead indication of soft tissue sarcomas,
and mid to high single-digit royalties for any additional
indications. CytRx also issued NantCell a warrant to purchase
on a split-adjusted basis up to 500,000 shares of common stock at
$6.60 over the next 18 months.
CytRx has been actively working with the NantCell team to
transition the aldoxorubicin program, including both completed and
ongoing studies.
Third Quarter 2017 Financial Results
CytRx reported cash, cash equivalents and short-term investments
of $46.0 million as of September 30, 2017. During the third
quarter, CytRx entered into a global strategic licensing agreement
for aldoxorubicin with NantCell and received a strategic investment
of $13.0 million. Concurrent
with the closing of the aldoxorubicin license agreement, CytRx
amended its existing long-term loan and made payments of
$10 million during the quarter to the
lender.
Net loss for the quarter ended September
30, 2017, was $5.1 million, or
$(0.19) per share, compared with a
net loss of $12.2 million, or
$(0.80) per share, for the quarter
ended September 30, 2016, a reduction
of $7.1 million. During the
third quarter of 2017, the Company recognized a non-cash gain of
$3.8 million on the fair value
adjustment of warrant derivative liability related to warrants
issued in 2016, compared to a non-cash gain of $0.2 million during the third quarter of 2016
related to now expired warrants.
Research and development (R&D) expenses were $4.8 million for the third quarter of 2017,
including approximately $2.6 million
for aldoxorubicin, $1.0 million for
pre-clinical development of new albumin-binding, ultra-high potency
cancer drugs (Freiburg lab), and approximately $1.2 million for non-cash expenses and general
operations of our clinical programs. This is a reduction of
approximately 47 percent compared to R&D expenses of
$8.9 million for the third quarter of
2016.
General and administrative (G&A) expenses were $3.4 million for the third quarter of 2017,
compared with $2.8 million for the
third quarter of 2016.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical company specializing in
research and clinical development of novel anti-cancer drug
candidates that employ linker technologies to enhance the
accumulation and release of drug at the tumor. Aldoxorubicin,
CytRx's most advanced drug conjugate, is an improved version of the
widely used chemotherapeutic agent doxorubicin and has been
out-licensed to NantCell, Inc. CytRx is also rapidly
expanding its pipeline of ultra-high potency oncology candidates at
its laboratory facilities in Freiburg, Germany, through its
LADR™ (Linker Activated Drug Release) technology platform, a
discovery engine designed to leverage CytRx's expertise in albumin
biology and linker technology for the development of a new class of
potential breakthrough anti-cancer therapies.
Forward-Looking Statements
This press release contains forward-looking statements. Such
statements involve risks and uncertainties that could cause actual
events or results to differ materially from the events or results
described in the forward-looking statements, including risks and
uncertainties relating to plans for regaining compliance with the
Nasdaq rules; the ability of NantCell, Inc., to obtain regulatory
approval for its products that use aldoxorubicin; the ability of
NantCell, Inc., to manufacture and commercialize products or
therapies that use aldoxorubicin; the amount, if any, of future
milestone and royalty payments that we may receive from NantCell,
Inc.; our ability to develop new ultra-high potency drug candidates
based on our LADRTM technology platform; and other
risks and uncertainties described in the most recent annual and
quarterly reports filed by CytRx with the Securities and Exchange
Commission and current reports filed since the date of CytRx's most
recent annual report. All forward-looking statements are based upon
information available to CytRx on the date the statements are first
published. CytRx undertakes no obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
michelle@argotpartners.com
CYTRX
CORPORATION
CONDENSED BALANCE SHEETS
(Unaudited)
|
|
September 30,
2017
|
December 31,
2016
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
45,995,642
|
$
56,959,485
|
|
Receivables
|
440,177
|
183,703
|
|
Prepaid expenses and
other current assets
|
2,016,636
|
3,434,238
|
|
Total current
assets
|
48,452,455
|
60,577,426
|
|
Equipment and
furnishings, net
|
1,177,271
|
1,959,667
|
|
Goodwill
|
183,780
|
183,780
|
|
Other assets
|
35,869
|
48,911
|
|
Total
assets
|
$
49,849,375
|
$
62,769,784
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
5,033,748
|
$
6,406,445
|
|
Accrued expenses and
other current liabilities
|
2,897,266
|
3,830,498
|
|
Warrant
liabilities
|
2,467,011
|
3,789,391
|
|
Term loan, net -
current
|
11,052,705
|
5,481,656
|
|
Deferred
revenues
|
6,924,353
|
—
|
|
Total current
liabilities
|
28,375,083
|
19,507,990
|
|
|
|
|
|
Long term loan,
net
|
—
|
18,484,510
|
|
Total
liabilities
|
28,375,083
|
37,992,500
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Stockholders' equity
(2016 restated to reflect a 1-6 reverse stock split, see Note
1):
|
|
|
|
Preferred Stock,
$0.01 par value, 833,334 shares authorized, including 4,167 shares
of Series A Junior Participating Preferred Stock; no shares issued
and outstanding
|
—
|
—
|
|
Preferred Stock,
$1,000 stated value, 650 shares authorized, 0 and 518 outstanding
at September 30, 2017 and December 31, 2016
|
—
|
518,000
|
|
Common stock, $0.001
par value, 41,666,667 shares authorized; 27,637,634 shares
issued and outstanding at September 30, 2017; 18,553,816 shares
issued and outstanding at December 31, 2016
|
27,638
|
18,554
|
|
Additional paid-in
capital
|
467,839,469
|
440,106,725
|
|
Accumulated
deficit
|
(446,392,815)
|
(415,865,995)
|
|
Total
stockholders' equity
|
21,474,292
|
24,777,284
|
|
Total
liabilities and stockholders' equity
|
$
49,849,375
|
$
62,769,784
|
|
CYTRX
CORPORATION CONDENSED STATEMENTS OF
OPERATIONS (Unaudited)
|
|
Three Months
Ended
September
30,
|
Nine Months
Ended
September
30,
|
|
2017
|
2016
|
2017
|
2016
|
Revenue:
|
|
|
|
|
License
revenue
|
$
—
|
$
—
|
$
—
|
$
100,000
|
|
|
|
|
|
Expenses:
|
|
|
|
|
Research and
development
|
4,755,191
|
8,927,037
|
17,675,079
|
29,531,609
|
General and
administrative
|
3,418,808
|
2,771,732
|
9,534,872
|
12,859,069
|
|
8,173,999
|
11,698,769
|
27,209,951
|
42,390,678
|
|
|
|
|
|
Loss before other
income (loss)
|
(8,173,999)
|
(11,698,769)
|
(27,209,951)
|
(42,290,678)
|
|
|
|
|
|
Other income
(loss):
|
|
|
|
|
Interest
income
|
119,900
|
68,635
|
271,292
|
195,809
|
Interest
expense
|
(828,120)
|
(781,038)
|
(2,999,230)
|
(1,939,186)
|
Other (loss),
net
|
(6,055)
|
(10,489)
|
(16,722)
|
(4,398)
|
Gain (loss) on
warrant derivative liabilities
|
3,763,855
|
246,211
|
(572,209)
|
939,668
|
|
|
|
|
|
Net loss
|
$
(5,124,419)
|
$
(12,175,450)
|
$
(30,526,820)
|
$
(43,098,785)
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.19)
|
$
(0.80)
|
$
(1.33)
|
$
(3.45)
|
|
|
|
|
|
Basic and diluted
weighted-average shares outstanding
|
26,618,098
|
15,173,742
|
22,936,843
|
12,500,295
|
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SOURCE CytRx Corporation