On August 10, 2015 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) reported financial results for the second quarter ended June 30, 2015, and provided an update on the company’s recent activities (Press release, Ziopharm, AUG 10, 2015, View Source [SID:1234507193]).
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"ZIOPHARM continues to make important headway, both in the lab and clinic, in the development of our novel gene and adoptive cell therapy programs and technologies," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "This includes advancement of several chimeric antigen receptor (CAR) and T-cell receptor (TCR) candidates toward the clinic, evolution of the Sleeping Beauty non-viral gene transfer platform, integration of RheoSwitch technology into various adoptive cell therapies and clinical strategies for controlled delivery of IL-12 using adenovirus. Working with Intrexon and our other partners, we look forward to advancing these cancer immunotherapies, and to presenting early data from across these platforms prior to the end of this year."
Recent Highlights
Ad-RTS-hIL-12
Ad-RTS-hIL-12 is a gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T cell immune response, using the RheoSwitch Therapeutic System (RTS) gene switch. In April 2015, ZIOPHARM announced the initiation of a Phase 1b/2 study of Ad-RTS-hIL-12 and veledimex following standard chemotherapy for the treatment of patients with locally advanced or metastatic breast cancer. In May 2015, the Company announced the initiation of a multi-center Phase 1 study of Ad-RTS-hIL-12 and veledimex in patients with recurrent or progressive glioblastoma multiforme, a form of brain cancer.
Both gene therapy trials, which are being conducted at leading centers across the U.S., are currently open and accruing patients. The Company expects that early results from each study will be presented at scientific meetings prior to year end.
ZIOPHARM also announced in July that the U.S. Food and Drug Administration granted Orphan Drug Designation for Ad-RTS-hIL-12 and veledimex in the treatment of patients with malignant glioma. The FDA’s Office of Orphan Products grants orphan drug status to support development of medicines for underserved patient populations or rare disorders affecting fewer than 200,000 people in the U.S. Orphan Drug Designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, an accelerated review process, accelerated approval where appropriate, grant funding, tax benefits and an exemption from user fees.
Adoptive Cell Therapies
In March 2015, ZIOPHARM and its partner Intrexon (NYSE:XON) announced a global collaboration focused exclusively on novel chimeric antigen receptor T-cell (CAR-T) products with the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. Under terms of the agreement, Intrexon will share the economic provisions of the collaboration, including an upfront payment, milestones and royalties, equally with ZIOPHARM. On July 31, 2015, ZIOPHARM received $57.5 million from Intrexon related to the upfront payment.
The collaboration’s first two CAR-T targets of interest were recently selected, and Intrexon and ZIOPHARM have initiated research and development efforts on these programs. The specific targets were not disclosed. Under the terms of the agreement, ZIOPHARM and Intrexon will also independently conduct research and development on other CAR-T candidates, with the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, having the opportunity to opt-in during clinical development.
ZIOPHARM’s other oncology programs, including those related to TCR and natural killer (NK) cells, continue to advance independently under its Exclusive Channel Collaboration (ECC) with Intrexon.
ZIOPHARM expects that results from its adoptive cell therapy programs, including data highlighting the advancement of the Sleeping Beauty non-viral gene transfer technology, will be presented at medical and scientific meetings prior to year end.
Corporate
In May 2015, ZIOPHARM announced the appointment of Dr. Cooper to the role of Chief Executive Officer. Dr. Cooper brings extensive experience in pioneering the development of adoptive cellular therapies in the field of oncology and translating immunology into clinical practice. Dr. Cooper joined ZIOPHARM from the University of Texas MD Anderson Cancer Center, where his appointments included tenured professor Pediatrics and Immunology; Section Chief Cell Therapy, Children’s Cancer Hospital; and Associate Director, Center for Cancer Immunology Research. Dr. Cooper is now a Visiting Scientist at MD Anderson.
In June 2015, the Company announced that Caesar J. Belbel, Executive Vice President, Chief Legal Officer and Secretary, had been appointed to the added role of Chief Operating Officer. Mr. Belbel joined ZIOPHARM Oncology in September 2011 as Executive Vice President and Chief Legal Officer. Mr. Belbel has over 25 years of experience in senior operational and corporate roles, with expertise in corporate strategy and management, mergers, acquisitions, divestitures and public and private financings.
Second-Quarter 2015 Financial Results
Net loss for the second quarter of 2015 was $14.2 million, or $(0.11) per share, compared to a net loss of $5.6 million, or $(0.06) per share, for the second quarter of 2014. Included in the loss for the second quarter of 2014 was non-cash income of $5.6 million, or $(0.06) per share for the change in fair value of warrants.
Research and development expenses were $7.4 million for the second quarter of 2015 compared to $8.3 million for the second quarter of 2014. The decrease of $0.9 million in research and development expenses is primarily attributable to reduced employee related and clinical study costs.
General and administrative expenses were $7.0 million for the second quarter of 2015 compared to $3.0 million for the second quarter of 2014. The increase of $4.0 million in general and administrative expenses is primarily attributable to non-cash equity compensation and other employee related expenses.
The Company ended the quarter with cash and cash equivalents of approximately $118.6 million. In addition, on July 31, 2015, the Company received $57.5 million from Intrexon related to the Merck Serono agreement. Given current development plans, the Company anticipates that current cash resources, including the recent cash payment received from Intrexon pursuant to the Merck Serono collaboration, will be sufficient to fund our planned operations into the first quarter of 2018.