LOS ANGELES, Aug. 3, 2017 /PRNewswire/ -- CytRx Corporation
(NASDAQ: CYTR), a biopharmaceutical research and development
company specializing in oncology, today announced financial results
for the quarter ended June 30, 2017, and provided an overview
of recent accomplishments and plans.
"We are very proud of the tireless work undertaken over the past
several months to secure a high-value, strategic partnership with
NantCell Inc. which charts the best path forward for aldoxorubicin,
through both expansion into multiple tumor types beyond soft tissue
sarcomas (STS) and innovative combinations with immuno-oncology and
cell-based therapies," said Steven A.
Kriegsman, CytRx's Chairman and CEO. "We believe
NantCell has the vision and expertise to maximize aldoxorubicin's
potential and bring it to the patients and physicians who need
it. Looking ahead for CytRx, we are rapidly expanding our
pipeline of ultra-high potency oncology candidates at our
laboratory in Freiburg, Germany,
using our 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."
Second Quarter 2017 and Recent Highlights
Entered an Exclusive Global Licensing Agreement and Strategic
Investment with NantCell for Aldoxorubicin. Last week, CytRx
and NantCell, Inc. (a private subsidiary of NantWorks, LLC)
executed a global strategic licensing agreement giving exclusive
rights to NantCell to develop and commercialize aldoxorubicin for
all indications. The NantCell team is led by Dr. Patrick Soon-Shiong, who developed, gained
regulatory approval under a 505(b)(2) pathway, and commercialized
Abraxane®, an albumin-mediated cytotoxic agent which currently
grosses approximately $1 billion in
annual sales. Under the terms of the agreement, NantCell
purchased $13 million of CytRx common
stock at a per share price of $1.10
representing approximately a 92% premium to the current market
price. CytRx is eligible to receive up to an additional
$343 million in regulatory and
commercial milestones, plus increasing double-digit royalties on
sales in 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
up to 3 million shares of common stock at $1.10 over the next 18 months.
Amended Long-Term Loan Facility. In conjunction
with the NantCell transaction, CytRx amended its long-term loan
facility and made a payment of $5
million to the lender upon the closing of the exclusive
global license and strategic investment for aldoxorubicin.
Appointed Dr. Shanta Chawla
Senior Vice President of Drug Development. In June 2017, CytRx announced the appointment of
Shanta Chawla, M.D., as the Senior
Vice President of Drug Development. Dr. Chawla has served as Vice
President of Clinical Development for three years and will assume
the leadership of CytRx's clinical and regulatory functions.
Presented Aldoxorubicin Clinical Trial Data in Patients with
Soft Tissue Sarcomas (STS) at the 2017 American Society of
Clinical Oncology Annual Meeting (ASCO). In June
2017, CytRx presented results from its global Phase 3 clinical
trial evaluating aldoxorubicin versus investigators' choice in
patients with relapsed and refractory STS (n=246) at ASCO 2017.
An oral presentation given by Sant
Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology
Center in Santa Monica and
principal investigator, described how aldoxorubicin demonstrated
median progression-free survival (PFS) of 5.32 months, compared to
a median PFS of 2.96 months for investigator's choice therapy, a
statistically significant improvement of 2.36 months (p=0.007;
hazard ratio (HR)=0.62, 95% CI 0.44-0.88), representing a 38%
reduction in the risk of tumor progression. In patients
treated in North
America plus Australia (n=312), aldoxorubicin
demonstrated a median PFS of 4.21 months, compared to a median PFS
of 2.96 months for investigator's choice therapy, a statistically
significant improvement of 1.25 months (p=0.023, HR=0.71, 95% CI
0.53-0.96). In the overall intent to treat (ITT) trial
population (n=433), aldoxorubicin performed better than
investigator's choice demonstrating a median PFS of 4.11 months,
compared to a median PFS of 2.96 months for investigator's choice
therapy, narrowly missing statistical significance (p=0.087;
HR=0.81, 95% CI 0.64-1.03). All responses in this study were
determined by an independent, blinded central lab assessment of
scans.
Presented Aldoxorubicin and Ifosfamide/Mesna Combination
Trial Data in Patients with Metastatic or Locally Advanced Sarcomas
at ASCO. In June 2017, CytRx
presented updated data from its ongoing Phase 1/2 clinical trial
combining aldoxorubicin with ifosfamide/mesna in patients with
first-line soft tissue sarcomas at ASCO 2017. Of the 44
evaluable patients as of May 10, 2017, 16 patients (36%)
achieved a partial response (PR), 25 patients (57%) achieved SD,
with 20 patients (45%) achieving SD for ≥4 months, for an overall
disease control rate (DCR) of 82% (PR+SD≥4). Twenty-two of 44
(50%) patients received at least 6 cycles of aldoxorubicin
(>1,300 mg/m2 cumulative doxorubicin
equivalent). As of the data cutoff date, the median PFS had
not been reached.
Completed $15 Million Financing. In May
2017, CytRx closed the sale of 30 million shares of
common stock in a public offering at a price of $0.50 per
share, resulting in net proceeds of approximately $14.0
million after deducting placement agent's fees and other
estimated offering expenses. Additionally, the Company
received approximately $2.8 million from the exercise of
warrants resulting in a total raise of $16.8 million in
the second quarter. Subsequent to the end of the second
quarter, 6.3 million warrants with a strike price of $0.70 expired on July
19, 2017.
Second Quarter 2017 Financial Results
CytRx reported cash, cash equivalents and short-term
investments of $55.0 million as of June 30, 2017.
Subsequent to the close of the quarter, CytRx entered into a global
strategic licensing agreement for aldoxorubicin with NantCell Inc.,
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 a payment of $5
million to the lender.
On May 2, 2017, CytRx completed a public offering
of 30 million shares of its common stock at a price
of $0.50 per share. The net proceeds to CytRx
from the offering, after deducting placement agent's fees and other
estimated offering expenses, were approximately $14.0
million. In addition, CytRx received $2.8
million in proceeds from the exercise of warrants in the
second quarter of 2017.
Net loss for the quarter ended June 30, 2017,
was $14.4 million, or $(0.10) per share, compared
with a net loss of $18.3 million, or $(0.27) per
share, for the quarter ended June 30, 2016, a reduction of
$3.9 million. During the second
quarter of 2017, the Company recognized a non-cash loss
of $4.3 million on the fair value adjustment of warrant
derivative liability related to warrants issued in 2016,
compared to a non-cash gain of $0.9 million during the
second quarter of 2016 related to now expired warrants.
Research and development (R&D) expenses were $6.2
million for the second quarter of 2017, and included
development expenses of $3.7 million for aldoxorubicin,
approximately $0.9 million for pre-clinical development
of new albumin-binding, ultra-high potency cancer drugs (German
lab), and approximately $1.6 million for non-cash
expenses and general operation of our clinical programs. This
is a reduction of approximately 50 percent compared to R&D
expenses of $12.5 million for the second quarter of
2016.
General and administrative (G&A) expenses were $3.1
million for the second quarter of 2017, compared
with $6.1 million for the second quarter of 2016, a
reduction of $3 million.
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: 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;
our ability to develop new ultra-high potency drug candidates based
on our LADR™ 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.
Company Contact:
CytRx Corporation
David J. Haen
Vice President, Business Development and Investor Relations
(310) 826-5648, ext 304
dhaen@cytrx.com
Media Contact:
Argot Partners
Eliza Schleifstein
(973) 361-1546
eliza@argotpartners.com
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
michelle@argotpartners.com
|
|
CYTRX
CORPORATION
|
CONDENSED BALANCE
SHEETS
|
(Unaudited)
|
|
|
June 30,
2017
|
|
December 31,
2016
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
54,972,846
|
|
$
56,959,485
|
Receivables
|
47,631
|
|
183,703
|
Prepaid expenses and
other current assets
|
1,782,141
|
|
3,434,238
|
Total current
assets
|
56,802,618
|
|
60,577,426
|
Equipment and
furnishings, net
|
1,323,579
|
|
1,959,667
|
Goodwill
|
183,780
|
|
183,780
|
Other assets
|
38,014
|
|
48,911
|
Total
assets
|
$
58,347,991
|
|
$
62,769,784
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
. Accounts
payable
|
$
7,080,080
|
|
$
6,406,445
|
Accrued expenses and
other current liabilities
|
2,972,082
|
|
3,830,498
|
Warrant
liabilities
|
6,567,080
|
|
3,789,391
|
Term loan, net –
current
|
6,701,040
|
|
5,481,656
|
Total current
liabilities
|
23,320,282
|
|
19,507,990
|
|
|
|
|
Long term loan,
net
|
15,813,507
|
|
18,484,510
|
Total liabilities
|
39,133,789
|
|
37,992,500
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred Stock,
$0.01 par value, 5,000,000 shares authorized, including 25,000
shares of Series A Junior Participating Preferred Stock; no shares
issued and outstanding
|
—
|
|
—
|
Preferred Stock,
$1,000 stated value, 3,900 shares authorized, 0 and 3,108
outstanding at June 30, 2017 and December 31, 2016
|
—
|
|
3,108,000
|
Common stock, $0.001
par value, 250,000,000 shares authorized; 153,127,389 shares
issued and outstanding at June 30, 2017; 111,322,895 shares issued
and outstanding at December 31, 2016
|
153,126
|
|
111,321
|
Additional paid-in
capital
|
460,329,472
|
|
437,423,958
|
Accumulated
deficit
|
(441,268,396)
|
|
(415,865,995)
|
Total stockholders'
equity
|
19,214,202
|
|
24,777,284
|
Total liabilities and
stockholders' equity
|
$
58,347,991
|
|
$
62,769,784
|
|
|
|
CYTRX
CORPORATION
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
Three Months
Ended June
30,
|
|
Six Months
Ended June
30,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenue:
|
|
|
|
|
|
|
|
License
revenue
|
$
—
|
|
$
100,000
|
|
$
—
|
|
$
100,000
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
Research and
development
|
6,167,074
|
|
12,452,340
|
|
12,934,058
|
|
20,604,559
|
General and
administrative
|
3,137,008
|
|
6,128,904
|
|
6,116,063
|
|
10,087,340
|
|
9,304,082
|
|
18,581,244
|
|
19,050,121
|
|
30,691,899
|
|
|
|
|
|
|
|
|
Loss before other
income (loss)
|
(9,304,082)
|
|
(18,481,244)
|
|
(19,050,121)
|
|
(30,591,899)
|
|
|
|
|
|
|
|
|
Other income
(loss):
|
|
|
|
|
|
|
|
Interest
income
|
90,849
|
|
65,436
|
|
151,392
|
|
127,174
|
Interest
expense
|
(848,395)
|
|
(741,346)
|
|
(2,171,110)
|
|
(1,158,148)
|
Other income (loss),
net
|
7,276
|
|
(798)
|
|
3,504
|
|
6,081
|
Gain (loss) on
warrant derivative liabilities
|
(4,303,945)
|
|
877,729
|
|
(4,336,066)
|
|
693,457
|
|
|
|
|
|
|
|
|
Net loss
|
$
(14,358,297)
|
|
$
(18,280,223)
|
|
$
(25,402,401)
|
|
$
(30,923,335)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.10)
|
|
$
(0.27)
|
|
$
(0.20)
|
|
$
(0.46)
|
|
|
|
|
|
|
|
|
Basic and diluted
weighted-average shares outstanding
|
139,070,329
|
|
67,398,837
|
|
126,394,244
|
|
66,893,846
|
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SOURCE CytRx Corporation