LOS ANGELES, May 8, 2018 /PRNewswire/ -- CytRx Corporation
(NASDAQ: CYTR), a biopharmaceutical research and development
company specializing in oncology, today announced financial results
for the quarter ended March 31, 2018,
and provided an overview of recent accomplishments and plans for
its research and development programs.
"We've had a strong start to 2018, highlighted by the
presentation of statistically significant breakthrough data for our
four new albumin binding ultra high potency LADR™ (Linker Activated
Drug Release) drug candidates at AACR 2018," said Eric Curtis, CytRx's President and Chief
Operating Officer. "The potential competitive advantages of the
LADR™ assets over antibody-drug conjugates are significant,
including broader therapeutic utility and patient populations,
lower risk of immune responses, lower cost of goods, simpler
manufacturing, and no requirement for antibody receptors. Looking
ahead to the remainder of 2018, we are laser-focused on securing a
strategic alliance for the innovative LADR™ technology, with the
goal of closing a transaction during the fourth quarter of
2018."
First Quarter 2018 and Recent Highlights
Eric L. Curtis is Named
President and Chief Operating Officer. In early May 2018, CytRx announced that its Board of
Directors had affirmed the appointment of Mr. Curtis to be the
President and Chief Operating Officer of CytRx. Mr. Curtis will be
part of CytRx's executive management team and will utilize his
significant development and operational expertise to partner the
Company's LADR™ technology and assets, as well as maximize the
success of CytRx's scientific programs. He had previously served as
an independent consultant for the Company's internal development
efforts and external partner relationships. Mr. Curtis, who holds
an M.B.A., brings more than 25 years of life science leadership
experience to CytRx, with a proven track record in oncology and
orphan diseases.
NantCell Inc.'s Aldoxorubicin Abstract Selected for
Presentation at the American Society of Clinical Oncology 2018
Annual Meeting. In April 2018,
CytRx highlighted that an abstract submitted by aldoxorubicin
licensee NantCell, Inc., a private subsidiary of NantWorks, LLC,
entitled Lack of cardiac toxicity in patients treated with
aldoxorubicin with doxorubicin equivalent doses beyond
1000mg/m2 was selected for a poster presentation at
the American Society of Clinical Oncology (ASCO) 2018 Annual
meeting, to be held June 1 - 5 in
Chicago. Dr. Sant Chawla, Principal Investigator and Director
of the Sarcoma Oncology Center in Santa
Monica, California, will be the presenter. CytRx
out-licensed global development, manufacturing, and
commercialization rights for aldoxorubicin to NantCell, Inc. in
July 2017.
Presented Statistically Significant Breakthrough LADR™
Candidate Data at the 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.
Selected Four LADR™ Candidates Eligible for IND-Enabling
Clinical Studies. In March 2018,
CytRx announced that four LADR™ candidates are eligible for
advancement into IND-enabling studies. These candidates, named
LADR-7, LADR-8, LADR-9 and LADR-10 were chosen from two distinct
classes of highly cytotoxic drugs, auristatins and
maytansinoids.
Patterson Derivative Action is Dismissed. In
March 2018, the Vice-Chancellor of
the Delaware Court of Chancery
ruled that CytRx's motion to dismiss was granted, with prejudice.
Patterson v. Kriegsman et al., C.A. No. 2017-0636-TMR.
Initiation of Pharma Partnering Activities for the LADR™
Ultra-High Potency Drug Candidates. In February and
March 2018, CytRx made two
announcements that highlighted efforts to strengthen its strategic
alliance team. First, CytRx announced that it had entered
into an exclusive agreement with Destum Partners, Inc., a leading
strategic advisory firm serving companies in the life sciences
industry, to assist in executing a strategic alliance for CytRx's
LADR™ drug candidates. CytRx also announced that Mr. Eric L. Curtis, MBA, joined its team to provide
strategic counsel to the Chairman and CEO for the Company's ongoing
programs, including its LADR™ discovery platform and the ultra-high
potency drug candidates. Mr. Curtis will foster introductions to
strategic partners from his extensive network of big
pharma and biotech companies. He brings a wealth of drug
development and commercialization experience to CytRx, and he,
along with Destum Partners, made introductions at AACR.
Partner NantCell Dosed First Patient in Clinical Trial
Investigating Cell-Based Therapy in Combination with Multiple
Anti-Cancer Agents, including Aldoxorubicin, in Patients with
Metastatic Pancreatic Cancer. In January
2018, CytRx announced that aldoxorubicin licensee NantCell,
Inc. (a private subsidiary of NantWorks, LLC) dosed
the first patient in the Phase 1b
portion of a Phase 1b/2 clinical
trial for patients with metastatic pancreatic cancer. The
trial will investigate high-affinity natural killer (haNK) cell
therapy in combination with several anti-cancer agents, including
aldoxorubicin, in patients with metastatic pancreatic cancer whose
cancer has progressed on or following standard-of-care
chemotherapy. This trial is a single-center, open-label, Phase
1b/2 clinical trial designed to
evaluate the safety and efficacy of the various combination
therapies with enrollment expected to be approximately 173
patients. The primary endpoint for the Phase 1b portion of the trial is safety and the primary
endpoint for the Phase 2 portion of the trial is objective response
rate (ORR) by RECIST.
Partner NantCell Dosed First Patient in Clinical Trial
Evaluating Aldoxorubicin in Combination with Immuno-Oncology Agents
and Cell-Based Therapies in Patients with Advanced Squamous Cell
Carcinoma. In February 2018,
CytRx announced that NantCell dosed the first patient in the Phase
1b portion of a Phase 1b/2 clinical trial for patients with advanced
squamous cell carcinoma (SCC) of either the head and neck or
non-small cell lung cancer, the second trial conducted by NantCell
to investigate haNK cell therapy in combination with several
anti-cancer agents, including aldoxorubicin, in certain high unmet
need cancer indications. This single-center, open-label,
Phase 1b/2 clinical trial is designed
to evaluate the safety and efficacy of the various combination
therapies, including combinations with aldoxorubicin, in subjects
with SCC who have progressed on or after platinum-based
chemotherapy and anti-PD1/PD-L1 therapy. Approximately 65 patients
are expected to be enrolled. The primary endpoint for the Phase
1b portion of the trial is safety and
the primary endpoint for the Phase 2 portion of the trial is
objective response rate (ORR) by RECIST.
First Quarter 2018 Financial Results
CytRx reported cash and cash equivalents of $35.1 million as of March
31, 2018.
Net loss for the quarter ended March 31,
2018, was $4.1 million, or
$(0.15) per share, compared with a
net loss of $11.0 million, or
$(0.60) per share, for the quarter
ended March 31, 2017, a reduction of
$6.9 million. Net loss decreased by
approximately 63% for the quarter ended March 31, 2018. During the first quarter of 2018,
the Company recognized a non-cash gain of $0.45 million on the fair value adjustment of
warrant derivative liabilities related to warrants issued in 2016,
compared to a non-cash loss of $32,000 during the first quarter of 2017 related
to now expired warrants.
Research and development (R&D) expenses were $1.5 million for the first quarter of 2018, which
were primarily incurred for preclinical development of the new
LADR™ albumin-binding, ultra-high potency drug candidates in the
Company's Freiburg, Germany
lab. This is a reduction of approximately $5.3 million compared to R&D expenses of
$6.8 million for the first quarter of
2017, which included clinical development expenses for
aldoxorubicin.
General and administrative (G&A) expenses were $2.5 million for the first quarter of 2018,
compared with $3.0 million for the
first quarter of 2017, including non-cash stock-compensation
expense of $0.4 million for the first
quarter of 2018 as compared to 0.6 million for the first quarter of
2017. G&A expenses decreased by approximately 17 percent
primarily due to a decrease in legal fees.
About the LADR™ Technology Platform
CytRx's innovative LADR™ (Linker Activated Drug Release)
technology employs a broad portfolio of novel linker molecules that
selectively bind to circulating albumin and can be linked to a wide
variety of anti-cancer payloads. The Company's research efforts
currently center on creating new molecules from the combination of
ultra-high potency cytotoxic payloads with tunable linkers. The
molecules that CytRx is currently evaluating concentrate at the
tumor site providing targeted delivery of the cell killing
payloads.
About CytRx Corporation
CytRx Corporation (NASDAQ: CYTR) 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. CytRx is
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. Aldoxorubicin, CytRx's most advanced drug
conjugate, is an improved version of the widely used anti-cancer
drug doxorubicin and has been out-licensed to NantCell, Inc.
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.; 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.
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
michelle@argotpartners.com
|
|
CYTRX
CORPORATION
|
CONDENSED BALANCE
SHEETS
|
(Unaudited)
|
|
|
March 31,
2018
|
December 31,
2017
|
ASSETS
|
|
|
Current
assets:
|
|
|
Cash and cash
equivalents
|
$
35,097,042
|
$
37,643,404
|
Receivables
|
6,347,014
|
7,529,032
|
Prepaid expenses and
other current assets
|
557,679
|
1,914,077
|
Total current
assets
|
42,001,735
|
47,086,513
|
Equipment and
furnishings, net
|
907,634
|
1,042,892
|
Goodwill
|
183,780
|
183,780
|
Other assets
|
34,334
|
34,334
|
Total
assets
|
$
43,127,483
|
$
48,347,519
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities:
|
|
|
Accounts
payable
|
$
3,471,183
|
$
4,122,017
|
Accrued expenses and
other current liabilities
|
8,322,796
|
8,029,274
|
Deferred
revenue
|
—
|
6,924,353
|
Warrant
liabilities
|
73,613
|
527,025
|
Term loan,
net
|
10,007,149
|
10,599,795
|
Total
liabilities
|
21,874,741
|
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; 28,037,501 shares issued
and outstanding at March 31, 2018 and December 31, 2017
|
28,037
|
28,037
|
Additional paid-in
capital
|
469,450,756
|
468,969,445
|
Accumulated
deficit
|
(448,226,051)
|
(450,852,427)
|
Total stockholders'
equity
|
21,252,742
|
18,145,055
|
Total liabilities and
stockholders' equity
|
$
43,127,483
|
$
48,347,519
|
|
The accompanying
notes are an integral part of these condensed financial
statements.
|
|
|
|
CYTRX
CORPORATION
|
CONDENSED
STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
Three Months
Ended
March
31,
|
|
2018
|
2017
|
Revenue:
|
|
|
License
revenue
|
$
—
|
$
—
|
|
|
|
Expenses:
|
|
|
Research and
development
|
1,455,806
|
6,772,582
|
General and
administrative
|
2,463,559
|
2,979,057
|
|
3,919,365
|
9,751,639
|
|
|
|
Loss before other
income (expense)
|
(3,919,365)
|
(9,751,639)
|
|
|
|
Other:
|
|
|
Interest
income
|
82,934
|
60,543
|
Interest
expense
|
(692,787)
|
(1,322,715)
|
Other income,
net
|
232
|
1,826
|
Gain (loss) on
warrant derivative liabilities
|
453,412
|
(32,119)
|
|
|
|
Net loss
|
$
(4,075,574)
|
$
(11,044,104)
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.15)
|
$
(0.60)
|
|
|
|
Basic and diluted
weighted-average shares outstanding
|
27,391,506
|
18,929,553
|
|
|
|
The accompanying
notes are an integral part of these condensed financial
statements
|
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SOURCE CytRx Corporation