LOS ANGELES, Nov. 2, 2018 /PRNewswire/ -- CytRx
Corporation (Nasdaq: CYTR), a biopharmaceutical research and
development company specializing in oncology, today announced
financial results for the quarter ended September 30, 2018, and provided an overview of
recent accomplishments and plans for its research and development
programs.
"The third quarter of 2018 was highlighted by the filing of a
provisional patent by Centurion BioPharma for the breakthrough
albumin companion diagnostic (ACDx) for use alongside our
innovative LADR™ (Linker Activated Drug Release) assets," said
Eric Curtis, CytRx's President and
Chief Operating Officer. "This new intellectual property is an
important component of the overall LADR value proposition and will
enhance our efforts to secure a strategic partnership to further
advance these unique, promising assets, with the overarching goal
of bringing these albumin binding ultra-high potency drug
candidates to the physicians and patients who need them."
"Also during the quarter, we were pleased to make the final
payment under our long-term loan agreement, and thereby
extinguishing all of our outstanding debt. We also saw the
expiration of approximately 3.2 million outstanding warrants for
shares of our common stock, improving our overall capital
structure."
Third 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.
CytRx Corporation
- Receipt of Milestone Payment from Orphazyme A/S. In
September 2018, CytRx announced receipt of a milestone payment
totaling $250,000 (USD) from Orphazyme
A/S (CPH: ORPHA). The payment was a result of
Orphazyme dosing the first patient in their Phase 3 clinical
trial evaluating arimoclomol in patients with amyotrophic lateral
sclerosis. Orphazyme, a public company trading on the Nasdaq
Copenhagen exchange, is testing arimoclomol in three additional
indications beyond ALS, including Niemann-Pick disease Type C,
Gaucher disease and sporadic Inclusion Body Myositis. Should
arimoclomol be approved for NPC
in Europe, CytRx will receive a $4
million milestone payment, plus royalties. Additional
arimoclomol milestones include $6 million upon approval
in the U.S. and $2 million upon approval in Japan,
plus royalties on net sales in all territories.
- Paid Off Long-Term Loan. In August
2018, CytRx announced that it made the final payment
under a long-term loan agreement. As of August 1, 2018, the
loan was paid in full, which extinguished all of CytRx's
outstanding debt.
- Expiration of the Majority of 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.
- Participated in Three Institutional Investor
Conferences. During the third
quarter, CytRx participated in three institutional
investor conferences in New York
City, including the H.C. Wainwright & Co.
20th Annual Global Investment Conference, the 2018
MicroCap Conference and the Singular Research Summer Solstice 2018 Conference. At each
conference, CytRx executive management made a formal
presentation and had one-on-one meetings with institutional
investors.
Third Quarter 2018 Financial Results
CytRx reported cash and cash equivalents of $24.7 million as of September 30, 2018.
Net loss for the quarter ended September
30, 2018, was $3.3 million, or
$(0.10) per share, compared with a
net loss of $5.1 million, or
$(0.19) per share, for the
comparative 2017 period, a reduction of $1.8
million, or approximately 36 percent. The comparative
2017 quarter included a non-cash gain of $3.8 million on the fair value adjustment of
warrant derivative liabilities related to warrants issued in 2016,
compared to no gain during the current third quarter related to
these now expired warrants.
Research and development (R&D) expenses were $0.9 million for the third quarter of 2018, which
represents primarily expenses for the development of the albumin
companion diagnostic (ACDx). In the third quarter of 2017,
R&D expenses of $4.8 million
included $3.7 million related to our
aldoxorubicin program and its clinical support and $1.0 million for pre-clinical development of new
albumin-binding, ultra-high potency cancer drugs.
General and administrative (G&A) expenses were $2.4 million for the third quarter of 2018,
compared with $3.4 million for the
third quarter of 2017. G&A expenses decreased by approximately
31 percent primarily due to a decrease in professional
fees.
Based on our currently projected expenditures for the next 13
months our monthly burn rate is estimated at
approximately $700,000 per month.
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: 4382473. 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: 4382473.
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 continued use and growth of
immunotherapy drugs by Big Pharma; 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.; risks and uncertainties
relating to the ability of Orphazyme A/S to obtain regulatory
approval for its products that use arimoclomol; the ability
of Orphazyme A/S to manufacture and commercialize products or
therapies that use arimoclomol; the amount, if any, of future
milestone and royalty payments that we may receive
from Orphazyme A/S; 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)
|
|
|
|
|
|
September 30,
2018
|
|
December 31,
2017
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
24,668,339
|
|
$
37,643,404
|
Receivables
|
5,981,040
|
|
7,529,032
|
Prepaid expenses and
other current assets
|
1,252,186
|
|
1,914,077
|
Total current
assets
|
31,901,565
|
|
47,086,513
|
Equipment and
furnishings, net
|
646,500
|
|
1,042,892
|
Goodwill
|
183,780
|
|
183,780
|
Other assets
|
34,334
|
|
34,334
|
Total
assets
|
$
32,766,179
|
|
$
48,347,519
|
LIABILITIES AND
STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
Accounts payable
|
$
2,900,758
|
|
$
4,122,017
|
Accrued expenses and
other current liabilities
|
7,515,258
|
|
8,029,274
|
Deferred
revenue
|
—
|
|
6,924,353
|
Warrant
liabilities
|
—
|
|
527,025
|
Term loan,
net
|
—
|
|
10,599,795
|
Total
liabilities
|
10,416,016
|
|
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 September 30, 2018; 28,037,501 shares
issued and outstanding at December 31, 2017
|
33,637
|
|
28,037
|
Additional paid-in
capital
|
476,843,206
|
|
468,969,445
|
Accumulated
deficit
|
(454,526,680)
|
|
(450,852,427)
|
Total stockholders'
equity
|
22,350,163
|
|
18,145,055
|
Total liabilities and
stockholders' equity
|
$
32,766,179
|
|
$
48,347,519
|
CYTRX
CORPORATION
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
|
|
|
|
|
|
Three Months
Ended
September
30,
|
|
Nine Months
Ended
September
30,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenue:
|
|
|
|
|
|
|
|
Licensing
revenue
|
$
250,000
|
|
$
—
|
|
$
250,000
|
|
$
—
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
Research and
development
|
909,712
|
|
4,755,191
|
|
3,186,839
|
|
17,675,079
|
General and
administrative
|
2,360,996
|
|
3,418,808
|
|
6,514,107
|
|
9,534,872
|
|
3,270,708
|
|
8,173,999
|
|
9,700,946
|
|
27,209,951
|
|
|
|
|
|
|
|
|
Loss before other
income
|
(3,020,708)
|
|
(8,173,999)
|
|
(9,450,946)
|
|
(27,209,951)
|
|
|
|
|
|
|
|
|
Other income
(loss):
|
|
|
|
|
|
|
|
Interest
income
|
93,391
|
|
119,900
|
|
269,299
|
|
271,292
|
Interest
expense
|
(363,086)
|
|
(828,120)
|
|
(1,715,733)
|
|
(2,999,230)
|
Other (loss),
net
|
(641)
|
|
(6,055)
|
|
(5,848)
|
|
(16,722)
|
Gain (loss) on
warrant derivative liabilities
|
—
|
|
3,763,855
|
|
527,025
|
|
(572,209)
|
|
|
|
|
|
|
|
|
Net loss
|
$
(3,291,044)
|
|
$
(5,124,419)
|
|
$
(10,376,203)
|
|
$
(30,526,820)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.10)
|
|
$
(0.19)
|
|
$
(0.34)
|
|
$
(1.33)
|
|
|
|
|
|
|
|
|
Basic and diluted
weighted-average shares outstanding
|
32,991,506
|
|
26,618,098
|
|
30,242,788
|
|
22,936,843
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE CytRx Corporation