CytRx reports net loss of $0.6 million for third quarter 2011

Nov 9 2011

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today reported financial results for the three months and nine months ended September 30, 2011, and provided a business update.

"We recently reported favorable initial response and safety data from the ongoing Phase 1b/2 clinical trial with INNO-206," said Steven A. Kriegsman, CytRx President and CEO. "In the current portion of the trial, patients with late-stage solid tumors, mostly soft tissue sarcomas, are receiving INNO-206 at the dose planned for our upcoming international Phase 2b clinical trial in soft tissue sarcoma. At this dose, INNO-206 delivers doxorubicin at 3½ times the standard dose of doxorubicin, which is the only current FDA-approved treatment for this cancer. After completing four INNO-206 treatment cycles, one patient showed greater than 30% tumor shrinkage and four additional patients had stable disease. One patient's oral sarcoma was greatly reduced following a single INNO-206 treatment. Although derived from a limited number of patients in an ongoing trial, these results underscore what we view as the potential strength of this tumor-targeting doxorubicin conjugate.

"We intend to complete the INNO-206 Phase 1b/2 trial in parallel with our Phase 2b trial, which is slated to begin next month. We are looking forward to the presentation of the full, final results from the Phase 1b/2 trial at the June 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO), which is the premier educational and scientific event in the oncology community and highlights the most advanced treatments in cancer care.

"Next month, results from our ENABLE Phase 2 proof-of-concept clinical trial will be presented at the prestigious American Society of Hematology (ASH®) annual meeting. This trial is evaluating our Bcr-Abl, Lyn and Fyn kinase inhibitor bafetinib in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL) who had failed other treatments. In June we reported promising preliminary results from the ENABLE trial that showed bafetinib was clinically active in a group of patients with B-CLL, which is the most common form of leukemia in the Western world. We are now seeking a corporate partner to further advance bafetinib's continued development.

"We are excited by our clinical progress and the attention our oncology programs are receiving from these premier conferences. Importantly, we believe our financial resources are sufficient to support our operations through what we hope will be an exciting upcoming year," added Mr. Kriegsman.

Third Quarter 2011 Financial Results

CytRx reported a net loss of $0.6 million, or $0 per share, and comprehensive loss of $0.8 million, for the third quarter of 2011, which included a $4.3 million gain on warrant derivative liability related to warrants associated with past equity financings. The third quarter 2011 comprehensive loss included $263,000 of unrealized loss on available-for-sale securities of ADVENTRX Pharmaceuticals (NYSE Amex: ANX). For the third quarter of 2010, the net loss was $4.4 million, or $0.04 per share, and the comprehensive loss was $3.6 million. Third quarter 2010 net loss included comprehensive net income of $0.8 million for an unrealized gain on available-for-sale securities.

Research and development (R&D) expenses were $3.2 million for the third quarter of 2011 and included development expenses for the Company's programs of $2.1 million for INNO-206, $0.3 million for bafetinib and $0.2 million for tamibarotene. R&D expenses were $2.8 million for third quarter of 2010.

General and administrative (G&A) expenses remained relatively unchanged at $1.7 million and $1.8 million for the third quarters of 2011 and 2010, respectively. G&A expenses included $0.2 million of employee stock option expense in both quarters.

CytRx reported cash, cash equivalents and marketable securities of $41.4 million as of September 30, 2011, which included net proceeds of approximately $18.9 million from an underwritten public offering that closed August 1, 2011.