Achieves multiple milestones in the clinical development of leading oncology assets aldoxorubicin and tamibarotene
CytRx Reports Second Quarter 2012 Financial Results
(NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today reported financial results for the three months and six months ended June 30, 2012, and provided a business update.
“This is an incredibly exciting time at CytRx with many recent developments that are advancing our clinical programs,” said President and Chief Executive Officer Steven A. Kriegsman. “Importantly, we reported positive data at the ASCO conference in June from a Phase 1b/2 clinical trial with our doxorubicin tumor-targeting conjugate aldoxorubicin (formerly INNO-206) in patients with advanced soft tissue sarcomas. As the next step in this program, we plan to meet with the FDA later this year to discuss a potential Phase 3 pivotal trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy.
“We are delighted that the investment community has taken notice of our many accomplishments as reflected in our higher market capitalization.”
CytRx reported a net loss for the quarter ended June 30, 2012 of $13.3 million, or $0.63 per share. The Company’s net loss for the quarter was substantially impacted by an increase in the Company’s stock price, which resulted in an $8.5 million increase in the Company’s warrant derivative liabilities. Excluding that non-cash loss on warrant derivative liabilities, CytRx reported a net loss for the quarter of $4.7 million. This compares with a net loss of $3.1 million, or $0.20 per share, for the quarter ended June 30, 2011, which included a recognized non-cash gain of $0.6 million resulting from the change in value of warrant derivative liability. The Company reported no revenue for the second quarter of 2012, which compares with $150,000 in revenue for the second quarter of 2011.
Research and development (R&D) expenses were $2.7 million for the second quarter of 2012, which included $1.2 million in development expenses for the aldoxorubicin, $0.6 million in expenses for tamibarotene and $0.1 million in expenses for bafetinib. R&D expenses for the second quarter of 2012 increased from the second quarter of 2011, due primarily to higher costs associated with the clinical development of aldoxorubicin.
General and administrative (G&A) expenses were $2.1 million and $2.0 million for the second quarters of 2012 and 2011, respectively. G&A expenses for the second quarter of 2012 included $0.4 million of non-cash stock-compensation expense in both respective quarters.
CytRx reported cash, cash equivalents and marketable securities of $26.9 million as of June 30, 2012, compared with $36.0 million as of December 31, 2011. Total outstanding shares of 21.3 million as of June 30, 2012 reflected the 1-for-7 reverse stock split instituted in May 2012.
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. The CytRx oncology pipeline includes two programs in clinical development for cancer indications: and . With its tumor-targeted doxorubicin conjugate aldoxorubicin, CytRx has initiated an international Phase 2b clinical trial as a treatment for soft tissue sarcomas, has completed its Phase 1b/2 clinical trial primarily in the same indication, recently initiated both a Phase 2 trial for patients with advanced pancreatic ductal adenocarcinomas and a Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, and plans to meet with the FDA in the second half of 2012 to discuss a potential Phase 3 pivotal trial as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. Tamibarotene is being tested in a double-blind, placebo-controlled, international Phase 2b clinical trial in patients with non-small-cell lung cancer, and is in a Phase 2 clinical trial as a treatment for acute promyelocytic leukemia (APL). The Company completed its evaluation of a third drug candidate, bafetinib, in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about the Company, visit .
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. 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 relating to the outcome, timing and results of CytRx's clinical trials, including the international Phase 2b clinical trial with aldoxorubicin in patients with soft tissue sarcomas, the Phase 1b study of aldoxorubicin in combination with doxorubicin in patients with advanced solid tumors, the Phase 2 clinical trial with aldoxorubicin in patients with pancreatic cancer and the international Phase 2b clinical trial with tamibarotene in patients with non-small-cell lung cancer, risks related to the ability to obtain regulatory approval for any future clinical testing of aldoxorubicin or tamibarotene, uncertainties regarding whether CytRx will be permitted to conduct a Phase 3 clinical trial aldoxorubicin as a treatment for STS, the scope of clinical testing that may be required by regulatory authorities and the timing and outcome of further clinical trials, the risk that any future human testing of aldoxorubicin, tamibarotene or bafetinib might not produce results similar to those seen in past human or animal testing, risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including any future clinical development of aldoxorubicin, tamibarotene or bafetinib, and the 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.