ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a drug development company employing small molecule and synthetic biology approaches to cancer therapy, today reported financial results and key highlights for the three months ended September 30, 2011.
For the third quarter, the Company’s cash used in operations was $11.1 million, an increase of $5.3 million from $5.8 million for the same period of 2010. The increase in spending is attributable primarily to research and development activities for the palifosfamide pivotal Phase 3 trial (“PICASSO 3”), additional activities supporting palifosfamide development, and expenditures supporting the Company’s synthetic biology therapeutics development program established earlier this year. The Company ended the quarter with $118.9 million in cash and cash equivalents. The Company expects its existing cash resources to support current operations into early 2013.
The net loss for the third quarter of 2011 was $0.8 million, or $(0.01) per share, compared to net loss of $12.2 million, or $(0.26) per share for the third quarter of 2010. The decrease in net loss of $11.4 million was primarily attributable to a non-cash gain of $13.4 million realized by the Company as a result of a change in the liability associated with certain outstanding warrants. The Company expects its clinical trial expenses to continue to increase as patient enrollment for the PICASSO 3 trial is completed and as additional trials for palifosfamide and our DNA-based therapeutics are initiated or expanded.
The Company also announced today that the Independent Data Monitoring Committee (IDMC) for PICASSO 3 trial met recently for a second time to review trial data for safety and for futility. The IDMC again recommended that the trial continue with no changes. Targeted completion of enrollment for the PICASSO 3 trial is expected early in the first quarter of 2012. The outcome in progression-free survival, the study’s primary endpoint for accelerated approval, is anticipated in the second half of 2012 should the trial complete enrollment as expected.Third Quarter Highlights
- Announced the initiation of a Phase 1 clinical study of ZIN ATI-001 in advanced melanoma. In August, the Company announced that the first patient was dosed in a Phase 1 clinical study of ZIN ATI-001, a novel DNA-based therapeutic candidate, targeting patients with advanced melanoma. ZIN ATI-001 is the second clinical oncology product candidate from the ZIOPHARM-Intrexon Corporation exclusive synthetic biology channel partnership.
- Appointed Hagop Youssoufian, M.Sc., M.D., Executive Vice President and Chief Medical Officer. In July, the Company appointed Hagop Youssoufian, M.Sc., M.D., Executive Vice President and Chief Medical Officer. Recently the Company further expanded Dr. Youssoufian’s responsibilities to include research and he is now President of Research and Development and Chief Medical Officer. Dr. Youssoufian is responsible for the Company’s preclinical and clinical development strategies.
- Appointed Caesar J. Belbel, Executive Vice President, Chief Legal Officer and Secretary. In September, the Company appointed Caesar J. Belbel, Executive Vice President, Chief Legal Officer and Secretary of ZIOPHARM. In this position, Mr. Belbel is responsible for the Company’s legal affairs.