On May 7, 2020 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported its financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, Ziopharm, MAY 7, 2020, View Source [SID1234557279]).
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"We anticipate reporting milestones across all of our programs this year, even when factoring in the effects of the pandemic on our global community, and we are working to minimize the uncertainty around some of of our timelines," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer. "We continue to make progress toward initiating our TCR-T clinical trial at MD Anderson Cancer Center based on the Sleeping Beauty platform and look forward to providing an update on the status of this trial later this year. In our Controlled IL-12 platform for recurrent glioblastoma (rGBM), clinicians and healthcare workers continue to treat patients and facilitate patient enrollment and our anticipated milestones in this program are on track. The National Cancer Institute (NCI) and MD Anderson have limited nonclinical and clinical research in response to COVID-19 which impacts their partners, and which will temporarily delay the initiation of our clinical trials with each institution. We are working closely with them to undertake our trials once the restrictions ease; however, the timing is not under our control."
"The Company is in a strong financial position, having completed a financing during the first quarter prior to the impact of the pandemic in the United States," added Sath Shukla, Chief Financial Officer. "With over $170 million in cash and investments available to support our programs, we are well positioned to weather this storm and continue executing on our strategic objectives."
Recent Corporate Highlights
Sleeping Beauty TCR-T Program
NCI Phase 2 TCR-T Study. During the quarter, the Ziopharm team worked with the NCI to advance preparations for dosing the first patient, including work on screening patients and final engineering
runs. As a result of COVID-19, the NCI has instituted significant work restrictions which unavoidably impacts research with its partners and have in turn delayed the dosing of the first patient in our TCR-T trial under the CRADA. Ziopharm is able to use its expanded laboratories in Houston to help complete the engineering runs and reduce future delays for this trial. The study is the first-in-human non-viral TCR-T study to be conducted at the NCI and details on the protocol are available on clinicaltrials.gov (NCT0402436).
Personalized and Library TCR-T Clinical Trial with MD Anderson. Based on instructive feedback from the U.S. Food and Drug Administration (FDA), the Company continues to make progress toward initiating its TCR-T clinical trial at MD Anderson based on the Sleeping Beauty platform. As previously guided, the Company plans to evaluate both its personalized TCR-T and its library TCR-T therapies and, in preparation for this trial, the Company has increased its R&D footprint at MD Anderson by leasing additional research and development facilities.
Controlled IL-12 Program
Phase 2 Combination Study. Under the Controlled IL-12 program, Ziopharm is actively enrolling patients in a phase 2 combination trial with Regeneron’s Libtayo to treat patients with rGBM. Per the study protocol, the Company expects to enroll at least 36 patients at approximately 10 sites. Enrollment for this study is anticipated to be completed in H1 2020. Accrual to the phase 1 monotherapy expansion protocol (NCT03679754) and combination study with OPDIVO were completed in 2019 (NCT03636477). The Company anticipates providing clinical updates at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual annual meeting in late May.
Sleeping Beauty CAR-T Program
Eden BioCell CAR-T Study. The Company’s joint venture partner, Eden BioCell, continued to make progress toward filing an IND this year for a clinical trial in Taiwan to assess patient-derived (autologous) CD19-specific CAR-T therapies, produced using a technology we refer to as Rapid Personalized Manufacturing (RPM).
Ziopharm CAR-T Study. The Company’s planned clinical trial infusing donor-derived (allogeneic) CD19-specific CAR-T therapies produced using RPM has been impacted by MD Anderson’s response to COVID-19, which impacts all their partners. This will unavoidably delay the dosing of the first patient in this trial. Institutional and federal regulatory documents are complete, manufacturing has been verified, but the site initiation visit is delayed due to the current work restrictions at MD Anderson. In response to COVID-19 and other considerations, the Company is prioritizing the work with Eden BioCell to develop autologous CAR-T under RPM given Eden BioCell’s technical progress and the favorable work environment in Taiwan, despite the pandemic. This helps conserve the Company’s financial resources while preserving Ziopharm’s rights to advance the technology in the U.S. and leverage clinical data from Greater China. Data from Eden BioCell and Ziopharm will collectively support the development of RPM technology.
Operational
Expanded Team, Board, and Capabilities. Ziopharm selectively expanded its team with new employees in cell therapy, manufacturing and clinical operations to further advance its programs, expand its capabilities and support its growth especially in Houston. The Company is recruiting additional personnel, including a Chief Medical Officer, and strengthening its business development and investor relations capabilities. Ziopharm also plans to selectively add to its Board of Directors, complementing its existing leadership in drug development, financing, and business development.
Strengthened Balance Sheet. The Company successfully raised over $100 million in net proceeds during the first quarter, extending its funding horizon into mid-2022. The additional funding provides for an accelerated buildout of its TCR-T program in Houston and the launch of Ziopharm-led TCR clinical trials for patients with solid tumors. The Company ended the first quarter of 2020 with approximately $171 million in cash, and another $18 million in capital pre-funded by MD Anderson available for the Company’s programs.
First Quarter 2020 Financial Results
Research and development expenses were $12.7 million for the first quarter of 2020, compared to $9.5 million for the first quarter of 2019, primarily reflecting increased clinical trial activity.
General and administrative expenses were $6.0 million for the first quarter of 2020, compared to $4.1 million for the first quarter of 2019. The increase in general and administrative expenses for the first quarter of 2020 is primarily due to increased headcount, legal costs associated with its expanded patent portfolio and facility costs.
Net loss for the first quarter of 2020, was $18.3 million, or $(0.09) per share, compared to a net loss of $13.4 million, or $(0.08) per share, for the first quarter of 2019.
Cash and cash equivalents, as of March 31, 2020 were $171.0 million.
A prepayment of approximately $18.0 million remains for work to be conducted by the Company at MD Anderson under the Company’s research and development agreements.
Conference Call and Webcast
Ziopharm will host a conference call and webcast for the investment community today, May 7, 2020, at 4:30 p.m. EDT. The conference call can be accessed by dialing 1-877-451-6152 (U.S. and Canada) or 1-201-389-0879 (international). The passcode for the conference call is 13701877. To access the live webcast or the subsequent archived recording, click here or visit the "Investors" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the company’s website for two weeks.