Attached files

file filename
8-K - 8-K FOR 2ND QUARTER 2016 EARNINGS ANNOUNCEMENT - CYTRX CORPform8k-q22016earnings.htm
Exhibit 99.1
 
 
CytRx Reports Second Quarter 2016 Financial Results
LOS ANGELES – July 29, 2016 -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today 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.
"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 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) 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.

About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin, its albumin-binding conjugate of the widely used chemotherapeutic agent doxorubicin, and DK049, a novel drug conjugate which is expected to enter clinical trials in 2017.  CytRx is also expanding its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx's expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome of the second analysis of the results of its Phase 3 clinical trial of aldoxorubicin in STS and end-of-Phase 3 meeting with the FDA, ongoing clincal tests of aldoxorubicin in SCLC and preclinical and planned clinical testing of its LADR™ linker technology platform, the risk that any future pre-clinical or human testing of compounds based on the LADR™ technology platform might not show efficacy or reduced side effects of those compounds, risks related to CytRx's ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx's need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 2 and Phase 3 clinical development of aldoxorubicin for SCLC and STS, respectively, and the preclinical and clinical development of compounds based on the LADR™ technology platform, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Company Contact:
CytRx Corporation
David J. Haen
Vice President, Business Development and Investor Relations
(310) 826-5648, ext. 304
dhaen@cytrx.com

Media Contact:
Argot Partners
Eliza Schleifstein
(917) 763-8106
eliza@argotpartners.com

Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
michelle@argotpartners.com

###

CYTRX CORPORATION
CONDENSED BALANCE SHEETS
(Unaudited)
   
June 30, 2016
   
December 31, 2015
 
ASSETS
           
Current assets:
           
Cash and cash equivalents
 
$
55,913,199
   
$
22,261,372
 
Short-term investments
   
     
35,035,420
 
Receivables
   
224,702
     
4,621,605
 
Prepaid expenses and other current assets
   
1,337,068
     
2,373,708
 
Total current assets
   
57,474,969
     
64,292,105
 
Equipment and furnishings, net
   
1,990,334
     
1,467,681
 
Goodwill
   
183,780
     
183,780
 
Other assets
   
685,385
     
1,080,872
 
Total assets
 
$
60,334,468
   
$
67,024,438
 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
                 
Current liabilities:
Accounts payable
 
$
7,293,498
   
$
8,058,624
 
Accrued expenses and other current liabilities
   
5,395,495
     
9,693,359
 
Non-cash litigation settlement due in shares of common stock
   
700,000
     
4,500,000
 
Warrant liability
   
     
693,457
 
Term loan, net - current
   
1,716,265
     
 
Total current liabilities
   
15,105,258
     
22,945,440
 
                 
Long term loan, net
   
21,870,212
     
 
     Total liabilities
   
36,975,470
     
22,945,440
 
Commitments and contingencies
               
                 
Stockholders' equity:
               
Preferred Stock, $0.01 par value, 5,000,000 shares authorized, including 25,000 shares of Series A Junior Participating Preferred Stock; no shares issued and outstanding
   
     
 
Common stock, $0.001 par value, 250,000,000 shares authorized;  68,371,643 shares issued and outstanding at June 30, 2016; 66,480,065 shares issued and outstanding at December 31, 2015
   
68,371
     
66,480
 
Additional paid-in capital
   
419,308,736
     
409,107,292
 
Accumulated deficit
   
(396,018,109
)
   
(365,094,774
)
Total stockholders' equity
   
23,358,998
     
44,078,998
 
Total liabilities and stockholders' equity
 
$
60,334,468
   
$
67,024,438
 


CYTRX CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)

   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2016
   
2015
   
2016
   
2015
 
Revenue:
                       
License revenue
 
$
100,000
   
$
   
$
100,000
   
$
 
                                 
Expenses:
                               
Research and development
   
12,452,340
     
10,008,304
     
20,604,559
     
22,573,181
 
General and administrative
   
6,128,904
     
4,191,769
     
10,087,340
     
7,322,001
 
     
18,581,244
     
14,200,073
     
30,691,899
     
29,895,182
 
                                 
Loss before other income (loss)
   
(18,481,244
)
   
(14,200,073
)
   
(30,591,899
)
   
(29,895,182
)
                                 
Other income (loss):
                               
Interest income
   
65,436
     
46,455
     
127,174
     
103,029
 
Interest expense
   
(741,346
)
   
     
(1,158,148
)
   
 
Other income (loss), net
   
(798
)
   
30,660
     
6,081
     
15,940
 
Gain on warrant derivative liability
   
877,729
     
2,435,865
     
693,457
     
564,570
 
                                 
Net loss
 
$
(18,280,223
)
 
$
(11,687,093
)
 
$
(30,923,335
)
 
$
(29,211,643
)
                                 
Basic and diluted net loss per share
 
$
(0.27
)
 
$
(0.21
)
 
$
(0.46
)
 
$
(0.52
)
                                 
Basic and diluted weighted-average shares outstanding
   
67,398,837
     
55,726,432
     
66,893,846
     
55,724,581
 

 
 
###