CytRx Corporation Reports Second Quarter 2019 Financial Results
LOS ANGELES, Aug. 9, 2019 /PRNewswire/ -- CytRx Corporation (OTCQB: CYTR), a biopharmaceutical research and development company specializing in oncology and rare diseases, today announced financial results for the second quarter ended June 30, 2019, and provided an overview of recent accomplishments.
"The first half of 2019 has been marked by significant achievements from our licensees, who continue to make progress in bringing CytRx's technology closer to patients who are in need of novel and innovative therapies," said Eric Curtis, CytRx's President and Chief Operating Officer. "As these partners continue to work diligently, CytRx stands to receive milestone payments and royalties, which may strengthen our balance sheet."
Second Quarter 2019 and Recent Highlights
CytRx Corporation
-- Orphazyme Prepares Regulatory Submission in United States and Europe for
Niemann-Pick Disease Type C. In July 2019, CytRx highlighted that
arimoclomol licensee Orphazyme announced that following a positive
meeting with the U.S. Food and Drug Administration (FDA), the Company
remains on track to submit a New Drug Application (NDA) for arimoclomol
in NPC in the first half of 2020. Orphazyme also updated the
anticipated timing for submission of its Marketing Authorization
Application (MAA) to the European Medicines Agency (EMA) seeking
approval for arimoclomol in Niemann-Pick disease Type C (NPC). Based on
advice received from the EMA's Scientific Advice Working Group,
Orphazyme expects to submit the arimoclomol MAA in the first half of
2020. CytRx is eligible to receive up to $120 million in future
milestones, plus royalties, from its arimoclomol licensing agreement
with Orphazyme. Specifically, CytRx is eligible to receive $6 million in
the U.S. and $4 million in Europe upon approval of arimoclomol in
Orphazyme's first non-ALS indication, plus royalties.
-- Licensee Orphazyme Completed Enrollment in Phase 3 Trial of Arimoclomol
in Amyotrophic Lateral Sclerosis. In July 2019, CytRx highlighted that
arimoclomol licensee Orphazyme A/S (ORPH.CO) has completed enrollment in
its Phase 3 trial evaluating arimoclomol for the treatment of
amyotrophic lateral sclerosis (ALS) ahead of schedule. Orphazyme
anticipates announcing top-line results from the Phase 3 trial in the
first half of 2021.
-- New Patent Issued for Aldoxorubicin Formulation. In June 2019, CytRx
highlighted that it has been issued a patent from the U.S. Patent and
Trademark Office (USPTO) covering the formulation, storage, delivery and
administration of aldoxorubicin at room temperature. The new patent,
which issued on June 25, 2019 as U.S. Patent No. 10,328,093 and is
titled "Anthracycline Formulations," covers a reconstituted formula of
aldoxorubicin that stabilizes the compound, solubilizes it in ethanol
and water, and eliminates the need for cold handling, allowing it to be
administered to patients in all potential disease indications at room
temperature.
-- CytRx Commences Trading on OTCQB Venture Market. In May 2019, CytRx
announced that it commenced trading on the OTCQB Venture Market. The
Company continues to trade under ticker symbol "CYTR". Investors can
find current financial disclosure and real-time Level 2 quotes for the
Company on www.otcmarkets.com/stock/CYTR/quote.
-- Patent Issued for the Use of Aldoxorubicin in the Treatment of Brain
Cancer. In May 2019, CytRx announced that it had been issued a patent
the USPTO covering the use of aldoxorubicin intravenously,
intra-arterially or intramuscularly for the treatment of brain cancer.
The new patent issued on May 7, 2019 as U.S. Patent No. 10,278,981, is
titled "Cytotoxic Agents for The Treatment of Cancer." This patent was
exclusively licensed by CytRx to NantCell in July 2017.
-- Orphazyme Completed Enrollment in its Phase 2/3 Clinical Trial in
Systemic Inclusion Body Myositis. In April 2019, CytRx highlighted that
arimoclomol licensee Orphazyme had completed enrollment in its Phase 2/3
clinical trial in Systemic Inclusion Body Myositis (sIBM). The Phase 2/3
trial is a 150-patient, 20-month, randomized, double-blind,
placebo-controlled trial in 11 centers in the United States and one in
the United Kingdom. Orphazyme expects to conduct an interim analysis in
the first half of 2020 and to complete the study by the end of 2020,
with results anticipated in the first half of 2021.
Second Quarter 2019 Financial Results
CytRx reported cash, cash equivalents and short-term investments of $19.4 million as of June 30, 2019.
Net loss for the quarter ended June 30, 2019 was $1.3 million, or $(0.04) per share, compared with a net loss of $ 3.0 million, or $(0.10) per share, for the quarter ended June 30, 2018, a reduction of $1.7 million.
General and administrative (G&A) expenses were $1.5 million for the second quarter of 2019, compared with $ 1.7 million for the second quarter of 2018, including non-cash stock-compensation expense of $0.2 million for the second quarter of 2019 as compared to $ 0.4 million for the second quarter of 2018. G&A expenses decreased by approximately $0.2 million, or 9.4%, primarily due to a decrease in legal fees and a reduction in head count.
Based on our currently projected expenditures for the next 13 months, our monthly cash burn rate is estimated at approximately $400,000 per month.
About CytRx Corporation
CytRx Corporation (OTCQB: CYTR) is a biopharmaceutical company with expertise in discovering and developing new therapeutics to treat patients with high unmet needs. 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. In addition, CytRx's other drug candidate, arimoclomol, has been out-licensed to Orphazyme A/S (Nasdaq Copenhagen exchange: ORPHA). Orphazyme is testing arimoclomol in four indications including amyotrophic lateral sclerosis (ALS), Niemann-Pick disease Type C (NPC), Gaucher disease and sporadic Inclusion Body Myositis (sIBM). CytRx Corporation's website is www.cytrx.com.
About Centurion Corporation
CytRx's subsidiary, Centurion BioPharma Corporation, is focused on the development of personalized medicine that is designed to transform solid tumor treatment. This transformational strategy combines a portfolio of novel, anti-cancer drug candidates that employ LADR(TM) (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(TM)-derived therapies. A critical element of the LADR(TM) 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 potential for aldoxorubicin to transform cancer treatment; the appeal of the reconstituted aldoxorubicin formula for patients and physicians; 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 ability of Orphazyme to obtain approval for the use of arimoclomol in treating Niemann-Pick disease; the ability of Orphazyme to enroll additional patients in future clinical trials; 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 and finance new ultra-high potency drug candidates based on its LADR(TM) technology platform; our ability to attract potential new 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/Maghan Meyers
(212) 600-1902
cytrx@argotpartners.com
CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, 2019
December 31,
2018
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $19,377,824 $21,373,273
Receivables 9,383 148,527
Prepaid expenses and other current assets 465,019 913,162
Current assets held for sale 49,436 81,182
Total current assets 19,901,662 22,516,144
Equipment and furnishings, net 28,067 44,326
Other assets 12,649 40,642
Non-current assets held for sale - 324,853
Total assets $19,942,378 $22,925,965
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $895,735 $1,234,762
Accrued expenses and other current liabilities 937,740 726,191
Current liabilities of discontinued operations 21,879 602,713
Total liabilities 1,855,354 2,563,666
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, 2019 and December 31, 2018 33,637 33,637
Additional paid-in capital 477,617,955 477,192,747
Accumulated deficit (459,564,568) (456,864,085)
Total stockholders' equity 18,087,024 20,362,299
Total liabilities and stockholders' equity $19,942,378 $22,925,965
CYTRX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
---
2019 2018 2019 2018
---
Revenue:
Licensing revenue
$ -
$ -
$ -
$ -
Expenses:
Research and development 580 (41,989) 1,056 614,277
General and administrative 1,531,073 1,689,553 3,268,223 4,153,112
---
1,531,653 1,647,564 3,269,279 4,767,389
---
Loss before other income (expense) (1,531,653) (1,647,564) (3,269,279) (4,767,389)
Other income (loss):
Interest income 104,095 92,975 192,405 175,909
Interest expense (659,860) (1,352,647)
Other income (loss), net 14,968 521 (2,321) 1,083
Gain on warrant derivative liabilities 73,613 527,025
Net loss from continuing operations (1,412,590) (2,140,315) (3,079,195) (5,416,019)
Gain (loss) from discontinued operations 138,095 (869,273) 378,712 (1,669,143)
---
Net loss $(1,274,495) $(3,009,588) $(2,700,483) $(7,085,162)
Basic and diluted loss per share
Continuing operations $(0.04) $(0.07) $(0.09) $(0.19)
Discontinued operations
$ - $(0.03) $0.01 $(0.06)
Total basic and diluted loss per share $(0.04) $(0.10) $(0.08) $(0.25)
Basic and diluted weighted-average shares outstanding 33,249,904 30,283,814 33,249,904 28,845,650
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SOURCE CytRx Corporation
