On July 29, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the three months ended June 30, 2016, and provided an overview of recent corporate developments and upcoming milestones for its research and development programs (Press release, CytRx, JUL 29, 2016, View Source;p=RssLanding&cat=news&id=2190084 [SID:1234514124]).
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"Our mission at CytRx is to bring new therapeutics to patients with cancer by applying our innovative Linker Activated Drug Release (LADR) technology to deliver cytotoxic payloads," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "As we await the second analysis for our Phase 3 trial of aldoxorubicin in second-line soft tissue sarcoma (STS) in the fourth quarter of 2016, we will continue to closely manage our spending. Our ongoing single-agent aldoxorubicin trials in glioblastoma and Kaposi’s sarcoma, along with our combination trials in STS and metastatic solid tumors are fully enrolled and either completed or near completion. Our Phase 2b second-line small cell lung cancer trial is 90 percent enrolled, and we currently anticipate reporting top-line results in the fourth quarter of 2016."
Second Quarter 2016 and Recent Developments
Reported Initial Results of Phase 3 Aldoxorubicin Trial in STS. On July 11, 2016, CytRx reported results of an analysis of its global, randomized, Phase 3 clinical trial of aldoxorubicin compared to investigator’s choice therapy in patients with relapsed or refractory STS. The analysis did not show a significant difference between aldoxorubicin and investigator’s choice therapy for progression-free survival (PFS), the study’s primary endpoint, with a median of 4.17 months and 4.04 months, respectively (hazard ratio: 0.91). The most immediate indications of therapeutic activity, objective response rate (ORR) and disease control rate (ORR + stable disease ≥ 4 months), showed a near doubling in the aldoxorubicin arm compared to investigator’s choice. CytRx believes that both PFS and response data need to be analyzed at a future date to include longer patient follow-up and allow for greater maturation of all endpoints. The Company expects to announce the results of this evaluation and hold an end-of-Phase 3 meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2016. In addition, patients continue to be followed for overall survival (OS), a secondary endpoint of the trial.
Completed $20 Million Financing. On July 20, 2016, CytRx completed a public offering of common stock and warrants that expire one year from issuance for total net proceeds of approximately $18.3 million.
Presented Updated Aldoxorubicin Clinical Trial Results at ASCO (Free ASCO Whitepaper) 2016. In June 2016, CytRx presented three posters featuring updated clinical data from its aldoxorubicin clinical trials at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting. The presented data highlighted aldoxorubicin’s safety and anti-tumor activity in multiple cancer types, including glioblastoma, Kaposi’s sarcoma and metastatic solid tumors.
Upcoming Milestones
Announce results of second analysis of Phase 3 aldoxorubicin clinical trial in patients with second-line STS, including longer patient follow-up and allowing for greater maturation of all endpoints, during the fourth quarter of 2016.
Hold an end-of-Phase 3 meeting with the FDA in the fourth quarter of 2016 regarding aldoxorubicin as a treatment for patients with advanced soft tissue sarcomas.
Currently anticipate reporting top-line results from the global Phase 2b clinical trial evaluating aldoxorubicin in patients with second-line small cell lung cancer (SCLC) in the fourth quarter of 2016.
Second Quarter 2016 Financial Results
CytRx reported cash and cash equivalents of $55.9 million as of June 30, 2016. Subsequent to the close of the second quarter, CytRx completed a public offering of common stock and warrants that expire one year from issuance for total net proceeds of approximately $18.3 million.
Net loss for the quarter ended June 30, 2016 was $18.3 million, or $0.27 per share, compared with a net loss of $11.7 million, or $0.21 per share, for the quarter ended June 30, 2015. During the second quarter of 2016, CytRx recognized a non-cash gain on warrant derivative liability of $0.9 million, compared to a non-cash gain of $2.4 million for the three-month period ended June 30, 2015. The Company recognized $0.1 million license revenue for the quarter ended June 30, 2016. The Company did not recognize revenues for the second quarter of 2015.
Research and development (R&D) expenses were $12.5 million for the second quarter of 2016, and included development expenses of $10.4 million for the aldoxorubicin program. R&D expenses were $10.0 million for the second quarter of 2015.
General and administrative (G&A) expenses were $6.1 million for the second quarter of 2016, compared to $4.2 million for the second quarter of 2015.