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CytRx Corporation Reports First Quarter 2019 Financial Results

Out-licensed Assets Aldoxorubicin and Arimoclomol Rapidly Advancing into Multiple Indications of High Unmet Need

CytRx Stands to Receive Significant Future Milestone Payments and Royalties from Licensing Agreements

LOS ANGELES, May 15, 2019 /PRNewswire/ -- CytRx Corporation (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.

(PRNewsfoto/CytRx Corporation)

"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™ (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™ 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™ 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 (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™ (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 and finance 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/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:

  Accounts payable

$         1,308,810


$         1,234,762

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







 

Cision

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