LOS ANGELES, May 10, 2017 /PRNewswire/ -- CytRx Corporation
(NASDAQ: CYTR), a biopharmaceutical research and development
company specializing in oncology, today announced financial results
for the quarter ended March 31, 2017,
and provided an overview of recent accomplishments and upcoming
milestones for its research and development programs.
"To date, 2017 has been marked by several key achievements, but
most importantly, by obtaining clarity from the U.S. Food and Drug
Administration (FDA) regarding our soft tissue sarcomas (STS)
program and the establishment of a definitive regulatory path
toward approval for aldoxorubicin as a treatment for patients with
this rare, difficult to treat disease," said Steven A.
Kriegsman, CytRx's Chairman and CEO. "Our Phase 3
trial investigating aldoxorubicin in patients with second-line STS
concluded and the data will be used to support our filing
strategy."
"Finally, we look forward to presenting the more detailed and
updated global Phase 3 STS results to the medical community at the
upcoming 2017 American Society of Clinical Oncology (ASCO) Annual
Meeting. This Phase 3 trial, along with the combination trial
of aldoxorubicin with ifosfamide/mesna, continue to build upon the
body of clinical data supporting aldoxorubicin's potential as a new
and better treatment for patients with STS," Mr. Kriegsman
commented.
First Quarter 2017 and Recent Highlights
Strengthened the Balance Sheet with $15 Million in Financing and $2 Million in Warrant
Proceeds. In early May
2017, CytRx completed the sale of approximately 30
million shares of common stock in a public offering at a price of
$0.50 per share, resulting in net
proceeds to the Company of approximately $13.9 million after deducting placement agent's
fees and other estimated offering expenses. Additionally, the
Company received approximately $1.9
million from the exercise of warrants resulting in a total
raise of $15.8 million subsequent to
March 31, 2017.
Concluded Phase 3 Trial Evaluating Aldoxorubicin in Relapsed
or Refractory STS. Based on its goal to submit a
rolling NDA, subject to approval from the FDA, the Company has
concluded its Phase 3 study evaluating aldoxorubicin compared to
investigator's choice in patients with relapsed or refractory
STS.
Aldoxorubicin Clinical Trial Data in Patients with STS
Selected for Oral Presentation at the 2017 American Society of
Clinical Oncology Annual Meeting (ASCO). In April
2017, CytRx announced that an abstract describing results from
its global Phase 3 clinical trial evaluating aldoxorubicin versus
investigators' choice in patients with relapsed and refractory STS
was selected for an oral presentation at ASCO 2017, taking place
June 2-6, 2017 in Chicago. The
oral presentation (abstract #11000) will be given by Principal
Investigator, Sant Chawla, M.D.,
F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, on Friday, June 2, 2017 between 3:00-6:00 pm CT. In addition to the STS
presentation, a poster (abstract #11051) highlighting updated data
from CytRx's ongoing Phase 1/2 clinical trial combining
aldoxorubicin with ifosfamide/mesna in patients with first-line
soft tissue sarcomas will also be presented by Frederick C. Eilber, M.D., Director of the UCLA
Sarcoma Translational Research Program within the Jonsson
Comprehensive Cancer Center, on Sunday, June
4, 2017 between 8:00-11:00 am
CT.
Announced FDA Agreement on Regulatory Pathway to Approval for
Aldoxorubicin in STS. In April 2017,
CytRx announced that it had reached an agreement with the FDA
on the pathway for a NDA submission for aldoxorubicin as a
treatment for STS. The Company's goal is to submit a rolling
NDA under section 505(b)(2) to the FDA in the fourth quarter of
2017. The commercial launch of aldoxorubicin is projected for
2018 in the U.S. Aldoxorubicin has received Orphan Drug
Designation from the FDA for the treatment of STS, which provides
for several benefits including seven years of market exclusivity
after approval, certain R&D related tax credits and protocol
assistance from the FDA. CytRx also plans to discuss with the
European Medicines Agency a path to filing a Marketing
Authorization Application. European regulators granted
aldoxorubicin Orphan Medicinal Product Designation for STS which
confers ten years of market exclusivity among other benefits.
Upcoming Milestones
- Present results from the Company's pivotal Phase 3 clinical
trial evaluating aldoxorubicin compared to investigator's choice in
patients with relapsed or refractory STS in an oral presentation at
ASCO 2017.
- Present updated data from the ongoing Phase 1b/2 clinical trial
of aldoxorubicin in combination with ifosfamide/mesna in patients
with advanced sarcomas in a poster presentation at ASCO 2017.
- Report top-line results from the global Phase 2b clinical trial
evaluating aldoxorubicin versus topotecan in patients with
second-line SCLC in the second quarter of 2017.
- Obtain FDA's permission to initiate a rolling NDA during
2017.
- Select the first internally developed ultra-high potency drug
conjugate candidate from its laboratory in Freiburg, Germany, for future development during
2017.
First Quarter 2017 Financial Results
CytRx reported cash, cash equivalents and short-term
investments of $48.0 million as of March 31,
2017.
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 $13.9 million. In
addition, CytRx received $1.9 million
in proceeds from the exercise of warrants in April and May 2017.
Net loss for the quarter ended March 31, 2017,
was $11.0 million, or $(0.10) per share, compared
with a net loss of $12.6 million, or $(0.19) per
share, for the quarter ended March 31, 2016. During the
first quarter of 2017, the Company recognized a non-cash loss
of $0.03 million on the fair value adjustment of warrant
derivative liability related to warrants issued in 2016,
compared to a non-cash loss of $0.2 million during the
first quarter of 2016 related to now expired warrants.
Research and development (R&D) expenses were $6.8
million for the first quarter of 2017, and included
development expenses of $4.0 million for aldoxorubicin,
approximately $0.6 million for pre-clinical development
of new albumin-binding, ultra-high potency cancer drugs (German
lab), and approximately $2.2 million for general
operation of our clinical programs. R&D expenses
were $8.2 million for the first quarter of 2016.
General and administrative (G&A) expenses were $3.0
million for the first quarter of 2017, compared with $4.0
million for the first quarter of 2016.
About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and
development company specializing in oncology. CytRx currently is
focused on the clinical development of aldoxorubicin, its improved
version of the widely used chemotherapeutic agent
doxorubicin. CytRx is also expanding its pipeline of 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 anti-cancer therapies.
Forward-Looking Statements
This press release contains forward-looking statements. Such
statements are not promises or guarantees, and involve numerous
risks and uncertainties that could cause actual events or results
to differ materially from the events or results described in the
forward-looking statements. These risks include: the timing
and final results of CytRx's clinical testing of aldoxorubicin;
timing of CytRx's preparation and submission of an NDA for
aldoxorubicin for the treatment of STS and FDA acceptance and
review of any NDA; the risk that CytRx may be unsuccessful in
obtaining FDA approval or, if approval is obtained, in
commercializing aldoxorubicin in the
United States or elsewhere; risks related to CytRx's need
for and ability to raise additional capital or enter into strategic
partnerships to fund its ongoing working capital needs and
development efforts; risks related to CytRx's ability to
manufacture its drug candidates in a timely fashion,
cost-effectively or in commercial quantities in compliance with
stringent regulatory requirements; risks relating to preclinical
testing of CytRx's LADR™ linker technology platform; risks related
to pending lawsuits against CytRx and its officers and directors;
and the other risks and uncertainties described in CytRx's Annual
Report on Form 10-K for the year ended December 31, 2016 filed with the Securities and
Exchange Commission. 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
Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
michelle@argotpartners.com
|
|
|
CYTRX
CORPORATION
|
|
CONDENSED BALANCE
SHEETS
|
|
(Unaudited)
|
|
|
March 31,
2017
|
|
December 31,
2016
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
48,003,315
|
|
$
56,959,485
|
|
Receivables
|
102,129
|
|
183,703
|
|
Prepaid expenses and
other current assets
|
2,650,682
|
|
3,434,238
|
|
Total current
assets
|
50,756,126
|
|
60,577,426
|
|
Equipment and
furnishings, net
|
1,903,904
|
|
1,959,667
|
|
Goodwill
|
183,780
|
|
183,780
|
|
Other assets
|
43,264
|
|
48,911
|
|
Total
assets
|
$
52,887,074
|
|
$
62,769,784
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
6,542,281
|
|
$
6,406,445
|
|
Accrued expenses and
other current liabilities
|
3,793,159
|
|
3,830,498
|
|
Warrant
liabilities
|
3,821,510
|
|
3,789,391
|
|
Term loan, net –
current
|
6,481,674
|
|
5,481,656
|
|
Total current
liabilities
|
20,638,624
|
|
19,507,990
|
|
|
|
|
|
Long term loan,
net:
|
17,586,113
|
|
18,484,510
|
|
Total
liabilities
|
38,224,737
|
|
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 March 31, 2017 and December 31, 2016,
respectively.
|
—
|
|
3,108,000
|
|
Common stock, $0.001
par value, 250,000,000 shares authorized; 118,722,895 and
111,322,895 shares issued and outstanding at March 31, 2017 and
December 31, 2016, respectively
|
118,721
|
|
111,321
|
|
Additional paid-in
capital
|
441,453,715
|
|
437,423,958
|
|
Accumulated
deficit
|
(426,910,099)
|
|
(415,865,995)
|
|
Total
stockholders' equity
|
14,662,337
|
|
24,777,284
|
|
Total
liabilities and stockholders' equity
|
$
52,887,074
|
|
$
62,769,784
|
|
|
|
|
CYTRX
CORPORATION
|
|
CONDENSED
STATEMENTS OF OPERATIONS
|
|
(Unaudited)
|
|
|
Three Months
Ended
March
31,
|
|
2017
|
|
2016
|
|
Revenue:
|
|
|
|
|
License
revenue
|
$
—
|
|
$
—
|
|
|
|
|
|
Expenses:
|
|
|
|
|
Research and
development
|
6,772,582
|
|
8,151,305
|
|
General and
administrative
|
2,979,057
|
|
3,958,434
|
|
9,751,639
|
|
12,109,739
|
|
|
|
|
|
Loss before other
income (expense)
|
(9,751,639)
|
|
(12,109,739)
|
|
|
|
|
|
Other:
|
|
|
|
|
Interest
income
|
60,543
|
|
61,738
|
|
Interest
expense
|
(1,322,715)
|
|
(416,803)
|
|
Other income,
net
|
1,826
|
|
5,964
|
|
Loss on warrant
derivative liabilities
|
(32,119)
|
|
(184,272)
|
|
|
|
|
|
Net loss
|
$
(11,044,104)
|
|
$
(12,643,112)
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.10)
|
|
$
(0.19)
|
|
|
|
|
|
Basic and diluted
weighted-average shares outstanding
|
113,577,313
|
|
66,488,855
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/cytrx-reports-first-quarter-2017-financial-results-300455045.html
SOURCE CytRx Corporation