LOS ANGELES, Aug. 6, 2018 /PRNewswire/ -- CytRx
Corporation (Nasdaq: CYTR), a biopharmaceutical research and
development company specializing in oncology, today announced
financial results for the quarter ended June
30, 2018, and provided an overview of recent accomplishments
and plans for its research and development programs.
"To date, 2018 has been marked by several important
achievements, most notably the launch of Centurion BioPharma
Corporation, which is focused on personalized medicine in advancing
our albumin binding ultra high potency LADR™ (Linker Activated Drug
Release) drug candidates and platform technology, and the filing of
a provisional patent application covering our breakthrough
companion diagnostic to be used alongside the LADR assets," said
Eric Curtis, CytRx's President and
Chief Operating Officer. "We are extremely excited about the
opportunity these innovative assets can offer to the oncology field
and we are diligently working to secure a strategic partnership to
advance them further."
"On the corporate and financial front, we have been executing on
several key initiatives, including increasing our participation at
institutional investor conferences, substantially reducing our cash
burn rate, and strengthening our balance sheet. These efforts,
combined with our addition to the Russell Microcap® Index,
leave us well positioned to achieve our corporate objectives for
the remainder of 2018," concluded Mr. Curtis.
Second Quarter 2018 and Recent Highlights
Centurion BioPharma Corporation
Breakthrough Personalized Medicine Companion Diagnostic Filed
for Albumin-Binding LADR™ Drug Candidates. In
July 2018, Centurion filed a
provisional patent application with the U.S. Patent and Trademark
Office covering its unique albumin companion diagnostic (ACDx) for
use alongside its albumin binding ultra-high potency LADR™ drug
candidates. The goal of ACDx is to identify patients with cancer
who are most likely to benefit from the treatment with the
Company's lead assets, LADR-7, LADR-8, LADR-9 and LADR-10 and any
albumin-binding drugs the Company may generate in the future.
Launched Centurion BioPharma Corporation. In June 2018, Centurion BioPharma Corporation, a
private wholly owned subsidiary, was launched by CytRx to focus on
the advancement of the LADRTM drug candidates and
technology platform. The subsidiary may develop novel drug
candidates on its own while out-licensing other assets for larger
patient populations. Eric L. Curtis
serves as Centurion BioPharma's President and Chief Executive
Officer.
CytRx Corporation
Paid Off Hercules Long-Term Loan Facility. In
August 2018, CytRx announced that it
made the final scheduled payment under a long-term loan facility
agreement with Hercules Technology Growth Capital, Inc. and
Hercules Technology III, L.P. As of August
1, 2018, the Hercules loan was paid in full, which
extinguished all of CytRx's outstanding debt.
Expiration of the Majority of Its Outstanding Warrants.
In July 2018, CytRx announced the
expiration of warrants for approximately 3.2 million shares of its
common stock. CytRx believes the expiration of these
warrants, the majority of which were associated with a public
offering in December 2016, eliminates
overhang and provides additional common share float stability.
Aldoxorubicin Included in New NantCell Inc. Triple Negative
Breast Cancer Clinical Trial. In June
2018, CytRx highlighted that aldoxorubicin licensee
NantCell, Inc. had dosed the first patient in the Phase
1b portion of a Phase 1b/2 clinical trial for patients with triple
negative breast cancer. This new trial represents the third
NantCell study evaluating aldoxorubicin combined with immunotherapy
or high affinity natural killer cell therapy in high unmet need
cancer indications.
Added to the Russell Microcap® Index. In June 2018, CytRx announced that it had been added
to the Russell Microcap Index®, effective upon the market open on
Monday, June 25, 2018. The Russell
indexes are broadly referenced as benchmarks by active investment
strategists and institutional investors for index funds. CytRx's
inclusion in the index highlights the growth CytRx has made as a
company.
Aldoxorubicin Reviewed in Future Oncology. In
June 2018, CytRx highlighted data on
licensee NantCell Inc's aldoxorubicin, which was published in the
peer-reviewed journal Future Oncology. The paper, published
June 5, 2018, is entitled
"Aldoxorubicin therapy for the treatment of patients with advanced
soft tissue sarcoma" and can be accessed online here. The paper
discusses the albumin-binding mechanism of action,
pharmacokinetics, preclinical studies, clinical trial data and the
safety profile of aldoxorubicin. It also discusses the potential
relevance in the future treatment of patients with sarcoma, or who
have other anthracycline sensitive tumor types, while avoiding
cardiotoxicity.
Aldoxorubicin Data Presented at the American Society of
Clinical Oncology (ASCO) 2018 Annual Meeting. In June 2018, CytRx highlighted NantCell Inc's
aldoxorubicin abstract selected for poster presentation at the ASCO
2018 Annual Meeting. The presented data showed that aldoxorubicin,
alone or in combination with ifosfamide, lacks cardiotoxicity with
doxorubicin equivalent doses beyond 1000 mg/m2.
The data, obtained from two clinical trials of aldoxorubicin,
contributes to the growing body of evidence showing that
aldoxorubicin may be able to improve antitumor activity without
typical doxorubicin-associated cardiac toxicity.
Eric L. Curtis named as
President and Chief Operating Officer. In May 2018, CytRx announced the appointment of
Eric L. Curtis as President and
Chief Operating Officer. Mr. Curtis is a seasoned professional with
25 years of experience in both oncology and orphan diseases,
including development and commercialization of approved drugs
Votrient®, Doxil®, Velcade®, Benlysta® and Tykerb®. CytRx has been
utilizing Mr. Curtis's extensive life science leadership to further
the LADRTM development program by working to secure a
strategic alliance for Centurion BioPharma Corporation.
Presented Statistically Significant Breakthrough LADR™ Drug
Candidate Data at the American Association for Cancer Research
(AACR) 2018 Annual Meeting. In April 2018, CytRx presented three posters
highlighting breakthrough data relating to its LADR™ drug
candidates at the AACR 2018 Annual Meeting in Chicago. The posters describe the positive
scientific findings that led to the Company's decision to select
auristatin E (AE) derivatives LADR-7 and LADR-8, and maytansine
derivatives LADR-9 and LADR-10, as the LADR™ candidates eligible to
advance toward IND-enabling studies. The compounds demonstrated
excellent, long-term antitumor activity across a wide range of
human solid tumor cancer types, including lung, breast, ovarian,
head and neck, renal cell, and melanoma. PDF copies of the
presented posters (abstracts #1657, #2661, and #3703) can be
accessed here.
Participated in Three Institutional Investor Conferences.
Over the past quarter, CytRx participated in three institutional
investor conferences, including the Singular Research Summer Solstice 2018 Conference in New York City, the OneMed NYC Oncology
Investor Conference 2018 in New York
City and the 8th Annual LD Micro Invitational
Conference in Bel-Air, California.
At each conference, CytRx executive management made a formal
presentation and had one-on-one meetings with institutional
investors.
Second Quarter 2018 Financial Results
During this quarter CytRx substantially reduced its monthly cash
burn rate, and expects to continue to manage its cash
effectively.
CytRx reported cash and cash equivalents of $36.4 million as of June
30, 2018.
Net loss for the quarter ended June 30,
2018, was $3.0 million, or
$(0.10) per share, compared with a
net loss of $14.4 million, or
$(0.60) per share, for the
comparative 2017 period, a reduction of $11.4 million, or approximately 79 percent.
During the second quarter of 2018, the Company recognized a
non-cash gain of $0.1 million on the
fair value adjustment of warrant derivative liabilities related to
warrants issued in 2016, compared to a non-cash loss of
$4.3 million during the second
quarter of 2017 related to these now expired warrants.
Research and development (R&D) expenses were $0.8 million for the second quarter of 2018,
which represents primarily $0.6
million of expenses for the development of the albumin
companion diagnostic (ACDx) and $0.2
million of non-cash expenses. In the second quarter of
2017, R&D expenses of $6.2
million included $4.3 million
related to our aldoxorubicin program and $0.9 million for non-cash expenses.
General and administrative (G&A) expenses were $1.7 million for the second quarter of 2018,
compared with $3.1 million for the
second quarter of 2017, including non-cash stock-compensation
expense of $0.4 million for the
second quarter of 2018 and $0.5
million for the second quarter of 2017. G&A expenses
decreased by approximately 46 percent primarily due to a decrease
in professional fees.
Conference Call and Webcast
CytRx will be hosting a conference call and webcast today
beginning at 11:00 am Eastern Time
(8:00 am Pacific Time). To access the
conference call, dial (+1)844-358-6753 (U.S. and Canada) or (+1)216-562-0397 (international
callers) and enter the conference ID number: 5991089. A live
and archived webcast will be available in the News and
Events/Events Calendar section of the Company's website,
www.cytrx.com. A replay of the call and webcast will begin
approximately two hours after the live call has ended. To
access the replay, dial (+1)855-859-2056 (U.S. and Canada) or (+1)404-537-3406 (international
callers) and enter the conference ID number: 5991089.
About CytRx Corporation
CytRx Corporation (Nasdaq: CYTR) is a biopharmaceutical
company with expertise in discovering and developing new
therapeutics to treat patients with cancer. CytRx's most
advanced drug conjugate, aldoxorubicin, is an improved version of
the widely used anti-cancer drug doxorubicin and has been
out-licensed to NantCell, Inc. CytRx
Corporation's website is www.cytrx.com.
About Centurion BioPharma Corporation
CytRx's wholly owned subsidiary, Centurion BioPharma
Corporation, is focused on the development of personalized medicine
that will transform solid tumor treatment. This transformational
strategy combines a portfolio of novel, anti-cancer drug candidates
that employ LADR™ (Linker Activated Drug Release) technology, a
discovery engine designed to leverage Centurion's expertise in
albumin biology and linker technology for the development of a new
class of breakthrough anti-cancer therapies with a unique albumin
companion diagnostic (ACDx) that can help identify patients who are
most likely to benefit from treatment with the LADR™-derived
therapies. A critical element of the LADR™ platform is its ability
to bind anti-cancer molecules to circulating albumin, the most
ubiquitous protein in human blood plasma, and then to release the
highly potent cytotoxic payload at the tumor site. This technology
allows for the delivery of higher doses of drug directly to the
tumor, while avoiding much of the off-target toxicity observed with
the parent molecules. Centurion BioPharma Corporation's website is
www.centurionbiopharma.com.
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, Inc.; Centurion BioPharma
Corporation's ability to develop new ultra-high potency drug
candidates based on its LADR™ technology platform; our ability to
attract potential licensees; 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
cytrx@argotpartners.com
CYTRX
CORPORATION
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(Unaudited)
|
|
|
|
June 30,
2018
|
|
|
December 31,
2017
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
36,426,292
|
|
|
$
|
37,643,404
|
Receivables
|
|
|
6,151,013
|
|
|
|
7,529,032
|
Prepaid expenses and
other current assets
|
|
|
227,708
|
|
|
|
1,914,077
|
Total current
assets
|
|
|
42,805,013
|
|
|
|
47,086,513
|
Equipment and
furnishings, net
|
|
|
780,592
|
|
|
|
1,042,892
|
Goodwill
|
|
|
183,780
|
|
|
|
183,780
|
Other
assets
|
|
|
34,334
|
|
|
|
34,334
|
Total
assets
|
|
$
|
43,803,719
|
|
|
$
|
48,347,519
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,633,428
|
|
|
$
|
4,122,017
|
Accrued expenses and
other current liabilities
|
|
|
7,581,180
|
|
|
|
8,029,274
|
Deferred
revenue
|
|
|
—
|
|
|
|
6,924,353
|
Warrant
liabilities
|
|
|
—
|
|
|
|
527,025
|
Term loan,
net
|
|
|
9,380,607
|
|
|
|
10,599,795
|
Total
liabilities
|
|
|
18,595,215
|
|
|
|
30,202,464
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
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, no shares issued and
outstanding
|
|
|
—
|
|
|
|
—
|
Common stock, $0.001
par value, 41,666,667 shares authorized; 33,637,501 shares issued
and outstanding at June 30, 2018; 28,037,501 shares issued and
outstanding at December 31, 2017
|
|
|
33,637
|
|
|
|
28,037
|
Additional paid-in
capital
|
|
|
476,410,506
|
|
|
|
468,969,445
|
Accumulated
deficit
|
|
|
(451,235,639)
|
|
|
|
(450,852,427
|
Total stockholders'
equity
|
|
|
25,208,504
|
|
|
|
18,145,055
|
Total liabilities and
stockholders' equity
|
|
$
|
43,803,719
|
|
|
$
|
48,347,519
|
CYTRX
CORPORATION
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
|
Three Months
Ended
June
30,
|
|
|
Six Months
Ended
June
30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing
revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
818,629
|
|
|
|
6,167,074
|
|
|
|
2,275,045
|
|
|
|
12,934,058
|
|
General and
administrative
|
|
|
1,689,553
|
|
|
|
3,137,008
|
|
|
|
4,153,112
|
|
|
|
6,116,063
|
|
|
|
|
2,508,182
|
|
|
|
9,304,082
|
|
|
|
6,428,157
|
|
|
|
19,050,121
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before other
income
|
|
|
(2,508,182)
|
|
|
|
(9,304,082)
|
|
|
|
(6,428,157)
|
|
|
|
(19,050,121)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
92,975
|
|
|
|
90,849
|
|
|
|
175,909
|
|
|
|
151,392
|
|
Interest
expense
|
|
|
(659,860)
|
|
|
|
(848,395)
|
|
|
|
(1,352,647)
|
|
|
|
(2,171,110)
|
|
Other income (loss),
net
|
|
|
(8,134)
|
|
|
|
7,276
|
|
|
|
(7,292)
|
|
|
|
3,504
|
|
Gain (loss) on
warrant derivative liabilities
|
|
|
73,613
|
|
|
|
(4,303,945)
|
|
|
|
527,025
|
|
|
|
(4,336,066)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,009,588)
|
|
|
$
|
(14,358,297)
|
|
|
$
|
(7,085,162)
|
|
|
$
|
(25,402,401)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
(0.10)
|
|
|
$
|
(0.60)
|
|
|
$
|
(0.25)
|
|
|
$
|
(1.20)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
weighted-average shares outstanding
|
|
|
30,283,814
|
|
|
|
23,178,389
|
|
|
|
28,845,650
|
|
|
|
21,065,708
|
|
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SOURCE CytRx Corporation