(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 Recent Highlights
- In July – initiated a Phase 1b clinical trial with a combination of aldoxorubicin and free doxorubicin in patients with solid tumors who had failed other therapies. The trial is being conducted under the direction of Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, California. Studies in animal models of human tumors showed favorable results from this combination in ovarian and pancreatic cancers.
- In July – received a key patent issuance providing significant intellectual property protection in the European Union for the INNO-206 linker technology, similar to the U.S. patent announced in April 2012. CytRx holds exclusive worldwide rights to this platform technology with proven affinity to couple with certain classes of chemotherapeutic agents beyond doxorubicin, making it essentially a product pipeline with blockbuster potential.
- In June – announced results from the Phase 1b/2 trial with aldoxorubicin that showed clinical benefit of more than four months in 77% of evaluable advanced soft tissue sarcoma patients who had been treated with drug at the maximum tolerated dose.
- In May – announced the publication in the peer-reviewed journal Clinical Cancer Research of animal and in vitro studies that showed aldoxorubicin produced anti-multiple myeloma effects with less toxicity than free doxorubicin. The study was conducted under the direction of Dr. James R. Berenson at the Institute for Myeloma & Bone Center Research.
- In July – received a notice of allowance for a patent application that strengthens the overall intellectual property for tamibarotene with claims covering a pharmaceutical composition of the potent, orally available synthetic retinoid compound in capsule form. CytRx holds the North American and European rights to certain tamibarotene intellectual property for the treatment of non-small-cell lung cancer (NSCLC) and acute promyelocytic leukemia (APL), and retains an option to expand its licenses for the use of tamibarotene in other fields in oncology.
- In June – reached a major milestone in the Phase 2b global clinical trial with tamibarotene as a first-line treatment for NSCLC with the Independent Data Safety Monitoring Board’s recommendation to move forward with the trial following a detailed review of safety data.
Second Quarter 2012 Financial Results
- In June – regained compliance with NASDAQ listing requirements.
- In June – added to the Russell Microcap Index, which is widely used by investment managers and institutional investors in their investments decisions.
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.