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CytRx Reports 2014 Second Quarter Financial Results

CytRx Corporation (CYTR), a biopharmaceutical research and development company specializing in oncology, today reported financial results for the three months ended June 30, 2014, and also provided an overview of recent accomplishments and upcoming milestones for its clinical development programs.

“We advanced the aldoxorubicin program in the second quarter of 2014 with important data presentations at AACR and ASCO, two of the most significant medical meetings in oncology,” said Steven A. Kriegsman, CytRx President and CEO. “We continue to see promising clinical results from aldoxorubicin in soft tissue sarcoma (STS) and both the completed Phase 1b/2 and Phase 2b clinical data build upon the growing body of scientific evidence supporting our pivotal global Phase 3 clinical trial in second-line STS, which is underway.”

Mr. Kriegsman added: “Looking ahead to the remainder of 2014, we remain on track to report initial overall survival (OS) results from the ongoing global Phase 2b clinical trial of aldoxorubicin as a first-line treatment for STS. We have also made great progress in our efforts to open our laboratory in Freiburg, Germany to conduct discovery and translational research to create new drug candidates that utilize novel linker technologies that couple chemotherapeutic agents and proteins either inside the body or externally, and then concentrate drug in tumors. The work done at our laboratory, which is expected to officially open on October 1, will generate new product candidates that will form the basis of the future drug pipeline of CytRx. We have accelerated this process by working with an established contract manufacturing company, to create our initial prototype molecules even before our laboratory officially opens.”

Second Quarter 2014 and Recent Highlights

Added to the Russell 3000® and Russell 2000® Indexes. In June, CytRx was added to the Russell 3000 ® and Russell 2000 ® Indexes when the Russell Investment Group completed the annual reconstitution of its family of U.S. indexes.

Reported Updated Results from Phase 2b Trial of Aldoxorubicin in Soft Tissue Sarcoma in an Oral Presentation at the 2014 ASCO Annual Meeting. In June, in an oral presentation at ASCO, CytRx reported updated results from its ongoing multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable STS. The updated trial results demonstrated that aldoxorubicin significantly increases progression-free survival (PFS), PFS at 6 months, overall response rate (ORR) and tumor shrinkage, compared to doxorubicin, the current standard-of-care, as a first-line treatment in patients with STS. The data trended in favor of aldoxorubicin for all of the major subtypes of STS.

Reported Final Phase 1b/2 Progression-Free Survival and Overall Survival Aldoxorubicin Data in Second-Line Soft Tissue Sarcoma. In May, CytRx reported updated PFS and OS results from its completed Phase 1b/2 clinical trial of aldoxorubicin in patients with advanced STS. Data from the Phase 1b/2 trial demonstrated that aldoxorubicin administered at its maximum tolerated dose (350mg/m2) showed a substantial increase in median PFS in patients with advanced STS (n=13). Partial responses were observed in 5 of 13 patients (38%) and stable disease was observed in 6 of 13 patients (46%). Median PFS of 6.4 months was initially reported at ASCO 2013 and ESMO 2013; in the final reported data, observed median PFS had nearly doubled to 11 months, and median OS was 17 months. Notably, following 8 cycles of aldoxorubicin, two patients experienced no progression of disease for 23 and 15 months, respectively, despite no further treatment. Aldoxorubicin was generally well tolerated with no observed cardiotoxicities and no drug-related deaths.

Hosted Research and Development Day. In May, CytRx hosted its first Research and Development Day at the Harvard Club in New York City. Members of the CytRx leadership team provided overviews of the Company’s development program for its lead product candidate, aldoxorubicin, and its Albumin-Binding Anti-Cancer Drug Platform. The event was attended by analysts and institutional investors and included presentations by, and a panel discussion with, key opinion leaders in oncology and sarcoma, including Daniel Von Hoff, MD, FACP, Physician in Chief and Director of the Translational Genomics Research Institute (TGEN) in Phoenix, Arizona, and Sant Chawla, MD, FRACP, the principal investigator for CytRx’s pivotal, global Phase 3 trial of aldoxorubicin for second-line treatment of STS.

Reported Positive Updated Preclinical Data from a Model of Human Glioblastoma at AACR 2014. At the 2014 American Association for Cancer Research (AACR) Annual Meeting in April, CytRx presented updated preclinical study results which demonstrated that aldoxorubicin significantly increased survival almost 2 ½ fold compared with doxorubicin treatment in an in vivo xenograft tumor model employing growth of human glioblastoma multiforme (GBM) tumors in mouse brains. Aldoxorubicin, but not doxorubicin, also demonstrated preferential accumulation and prolonged retention in the tumor tissue. These data, combined with aldoxorubicin’s favorable safety profile, support the current evaluation of aldoxorubicin as a potential treatment for patients with GBM tumors.

Upcoming Milestones

  • Initiate a global Phase 2b clinical trial of aldoxorubicin as a second-line treatment for small cell lung cancer (SCLC) in the second half of 2014
  • Announce initial OS results from the ongoing global Phase 2b clinical trial of aldoxorubicin as a first-line treatment for STS in the second half of 2014
  • Open our drug discovery laboratory in Freiburg, Germany in October, 2014
  • Announce preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin in glioblastoma multiforme in the coming year
  • Announce preliminary results from the ongoing Phase 2 clinical trial of aldoxorubicin in Kaposi’s Sarcoma in the second quarter of 2015
  • Complete enrollment in the ongoing pivotal global Phase 3 clinical trial of aldoxorubicin as a second-line treatment for STS in the second half of 2015
  • Expand the oncology pipeline by developing 1-2 drug candidates that utilize novel linker technologies that couple chemotherapeutic agents and proteins either inside the body or externally, and then concentrate drug in tumors in the second quarter of 2015

Second Quarter 2014 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $102.5 million as of June 30, 2014.

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