CytRx Corporation Reports First Quarter 2019 Financial Results
LOS ANGELES, May 15, 2019 /PRNewswire/ -- CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced financial results for the first quarter ended March 31, 2019, and provided an overview of recent accomplishments and plans for its research and development programs.
"2019 has been off to a successful start for CytRx," said Eric Curtis, CytRx's President and Chief Operating Officer. "While we continue to work diligently and determinedly to secure a strategic partnership for our albumin binding ultra-high potency LADR(TM) (Linker Activated Drug Release) assets and the accompanying albumin companion diagnostic (ACDx), we are pleased to see that our licensing partners, NantCell, Inc. (NantCell) and Orphazyme A/S (Orphazyme), are fully committed to developing aldoxorubicin and arimoclomol, respectively, and to exploring their utility in novel indications of high unmet need."
First Quarter 2019 and Recent Highlights
Centurion BioPharma Corporation
-- ACDx Manuscript Published in the Journal Nuclear Medicine and Molecular
Imaging. In March 2019, peer reviewed scientific research for
Centurion's ACDx was published online in the journal Nuclear Medicine
and Molecular Imaging. The manuscript, titled "Development of a Novel
Imaging Agent for Determining Albumin Uptake in Solid Tumors," can be
accessed and purchased online at
https://doi.org/10.1007/s13139-019-00587-w.
-- LADR-7 Scientific Research Published as Cover Story in the Journal of
Controlled Release. In February 2019, peer reviewed, scientific research
for LADR-7 (AE-Keto-Sulf07), one of Centurion's lead LADR(TM)
candidates, was published as a cover story in the Journal of Controlled
Release, a leading journal for drug delivery. The article, titled "Novel
auristatin E-based albumin-binding prodrugs with superior anticancer
efficacy in vivo compared to the parent compound," can be accessed and
purchased online at
https://www.sciencedirect.com/journal/journal-of-controlled-release/vol/
296.
-- Highlighted Important OncLive® Article Citing Majority of Cancer
Patients Do Not Have Targetable Genetic Mutations. In February 2019,
Centurion highlighted an OncLive® article citing that 65% of oncology
patients do not have targetable genetic mutations that would make them
eligible for targeted treatment and are therefore candidates for
chemotherapy. Centurion's core focus is on developing its LADR(TM) drug
candidates, which have the potential to improve efficacy and safety of
chemotherapy by targeting ultra-high potency drug delivery directly
inside the tumor.
CytRx Corporation
-- 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
from the U.S. Patent and Trademark Office (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.
-- Arimoclomol Clinical Milestone Guidance Provided by Licensee Orphazyme.
In May 2019, CytRx highlighted that arimoclomol licensee Orphazyme had
provided clinical guidance on arimoclomol development milestones through
2021 in its four indications, amyotrophic lateral sclerosis (ALS),
sporadic Inclusion Body Myositis (sIBM), Niemann-Pick disease Type C
(NPC) and Gaucher Disease. 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. As previously
announced, Orphazyme is engaging with both the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) on path to
approval while preparing for filing for NPC. CytRx is eligible to
receive up to $120 million in future milestones, plus royalties, from
its arimoclomol licensing agreement with Orphazyme.
-- Arimoclomol Licensee Orphazyme Completed Enrollment in its Phase 2/3
Clinical Trial in sIBM. In April 2019, CytRx highlighted that
arimoclomol licensee Orphazyme had completed enrollment in its Phase 2/3
clinical trial in 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.
-- Arimoclomol Licensee Orphazyme Reports Positive Phase 2/3 Clinical Data
in NPC. In February 2019, CytRx highlighted positive Phase 2/3 clinical
trial data reported by arimoclomol licensee Orphazyme in NPC. In this
full data set analysis, arimoclomol showed a 74% reduction in disease
progression after 12 months compared to placebo control
(p-value=0.0506), the primary endpoint of the trial.
-- Aldoxorubicin included in New NantCell Colorectal Cancer Clinical Trial.
In January 2019, CytRx highlighted that aldoxorubicin licensee NantCell
has dosed the first patient in the Phase 1b portion of a Phase 1b/2
clinical trial for patients with relapsed or refractory colorectal
cancer (CRC) who have been previously treated with standard of care
(SOC) therapy. This is the fourth trial conducted by NantCell which will
investigate high-affinity natural killer (haNK) cell therapy in
combination with anti-cancer agents, including aldoxorubicin, in certain
high unmet need cancer indications.
First Quarter 2019 Financial Results
CytRx reported cash, cash equivalents and short-term investments of $20.1 million as of March 31, 2019.
Net loss for the quarter ended March 31, 2019, was $1.4 million, or $(0.04) per share, compared with a net loss of $4.1 million, or $(0.15) per share, for the quarter ended March 31, 2018, a reduction of $2.7 million.
Research and development (R&D) expenses were $6,000 for the first quarter of 2019, compared to $656,000 for the first quarter of 2018, a reduction of $650,000.
General and administrative (G&A) expenses were $1.7 million for the first quarter of 2019, compared with $2.5 million for the first quarter of 2018, including non-cash stock-compensation expense of $0.2 million for the first quarter of 2019 as compared to $0.4 million for the first quarter of 2018. G&A expenses decreased by approximately $0.8 million, or 32%, 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 (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. 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 wholly owned 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 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 and finance new ultra-high potency drug candidates based on its LADR(TM) 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/Maghan Meyers
(212) 600-1902
cytrx@argotpartners.com
CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
March 31, 2019 December 31, 2018
---
ASSETS
Current assets:
Cash and cash equivalents $9,015,779 $21,373,273
Short-term investments 11,036,102 -
Receivables 158,280 148,527
Prepaid expenses and other current assets 845,950 913,162
Current assets held for sale 402,045 81,182
Total current assets 21,458,156 22,516,144
Equipment and furnishings, net 33,450 44,326
Other assets 15,179 40,642
Non-current assets held for sale - 324,853
---
Total assets $21,506,785 $22,925,965
===
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities: $1,308,810 $1,234,762
Accounts payable
Accrued expenses and other current liabilities 942,025 726,191
Current liabilities for sale 109,137 602,713
Total liabilities 2,359,972 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 March 31, 2019 and
December 31, 2018 33,637 33,637
Additional paid-in capital 477,403,249 477,192,747
Accumulated deficit (458,290,073) (456,864,085)
Total stockholders' equity 19,146,813 20,362,299
Total liabilities and stockholders' equity $21,506,785 $22,925,965
===
CYTRX CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended
March 31,
2019 2018
---
Revenue:
License revenue
$ -
$ -
Expenses:
Research and development 5,834 656,266
General and administrative 1,731,718 2,463,559
---
1,737,552 3,119,825
---
Loss before other income
(expense) (1,737,552) (3,119,825)
Other:
Interest income 88,310 82,934
Interest expense (692,787)
Other (expense) income, net (17,290) 562
Gain on warrant derivative
liabilities 453,412
Net loss from continuing
operations $(1,666,532) $(3,275,704)
Gain (loss) from
discontinued operations 240,544 (799,870)
---
Net loss $(1,425,988) $(4,075,574)
Basic and diluted loss per share
Continuing operations $(0.05) $(0.12)
Discontinued operations $0.01 $(0.03)
Total basic and diluted
loss per share $(0.04) $(0.15)
Basic and diluted weighted-
average shares outstanding 33,249,904 27,391,506
===
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