(NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today reported financial results for the three and nine-month periods ended September 30, 2013, and provided a clinical update.
“Our achievements during the third quarter and recent weeks position CytRx to make significant progress and create shareholder value for the remainder of 2013 and well into 2014,” said Steven A. Kriegsman, CytRx President and CEO. “With our cash position bolstered by a recent equity offering that netted approximately $24.1 million, we have the resources to continue a robust program of clinical trials with aldoxorubicin in multiple oncology indications. Later this week, we will be presenting further impressive preliminary results from our global Phase 2b clinical trial in first-line soft tissue sarcoma at the Connective Tissue Oncology Society Annual Meeting in New York.
“In the third quarter, we were excited to announce that aldoxorubicin significantly increased survival rates in mice transplanted with human glioblastoma cells in a confirmatory study, and demonstrated the ability in that study to cross the blood-brain barrier and induce key biomarkers that lead to glioblastoma tumor cell death. Glioblastoma is a deadly form of brain cancer, and we plan to initiate a Phase 2 trial later this year in patients with advanced, relapsed glioblastoma, and a Phase 2 trial in Kaposi’s sarcoma, a common HIV-associated tumor,” continued Mr. Kriegsman. “Finally, we expect to commence a global Phase 3 pivotal trial in the first quarter of 2014 to evaluate aldoxorubicin as a treatment for patients with second-line soft tissue sarcomas that have progressed following prior treatment with chemotherapy. That trial is being conducted under a special protocol assessment with progression-free survival as the primary endpoint.”
Recent Clinical Highlights
- July – reported highly favorable data from a human model of glioblastoma implanted in animals and treated with aldoxorubicin, including statistically significant efficacy and prolonged survival.
- September – announced preliminary data from the global Phase 2b soft tissue sarcoma trial showing patients treated with aldoxorubicin had an Overall Response Rate (ORR) of 22%, whereas those administered the widely used chemotherapeutic agent doxorubicin had an ORR of 0%.
Third Quarter 2013 Financial Results
- 4Q13 – initiate a Phase 2 trial with aldoxorubicin in patients with relapsed glioblastoma. Study site participants include The John Wayne Cancer Center in Santa Monica, Calif., the City of Hope in Duarte, Calif. and the LSU Health Science Center in New Orleans.
- 4Q13 – initiate a Phase 2 trial evaluating the preliminary efficacy of aldoxorubicin in treating AIDS-related Kaposi’s sarcoma; this trial will enroll up to 30 patients at the LSU Health Science Center.
- December 2013 – report top-line progression-free survival results from the global Phase 2b trial comparing the efficacy and safety of aldoxorubicin and doxorubicin as a first-line treatment for patients with soft tissue sarcoma.
- 1Q14 – initiate a global Phase 3 pivotal trial with aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma who have failed chemotherapy under a special protocol assessment.
- Ongoing – work to expand the oncology pipeline by combining our novel linker platform technology with additional chemotherapeutic agents.
The net loss for the third quarter of 2013 was $10.0 million, or $0.33 per share, compared with net income for the third quarter of 2012 of $1.6 million, or $0.07 per diluted share. The difference is largely attributable to the Company’s warrant derivative liabilities – In the third quarter of 2013, the Company recorded a loss of $4.0 million on warrant derivative liabilities, compared with a non-cash gain on warrant derivative liabilities of $6.4 million in the third quarter of 2012. The derivative liabilities are related to warrants issued in August 2011 and July 2009.
The Company did not recognize revenue for either quarter.
Research and development (R&D) expenses were $4.0 million for the third quarter of 2013, and included aldoxorubicin development expenses of $3.3 million. R&D expenses were $3.2 million for the third quarter of 2012.