On August 9, 2019 CytRx Corporation (OTCQB: CYTR), a biopharmaceutical research and development company specializing in oncology and rare diseases, reported financial results for the second quarter ended June 30, 2019, and provided an overview of recent accomplishments (Press release, CytRx, AUG 9, 2019, View Source [SID1234538569]).

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"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.