Threshold Pharmaceuticals
Nov 7, 2016
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Threshold Pharmaceuticals Reports Third Quarter Financial Results

-- Planning to initiate a clinical trial of evofosfamide in combination with checkpoint inhibitors --

SOUTH SAN FRANCISCO, Calif., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), a clinical-stage biopharmaceutical company developing novel therapies for cancer, today reported financial results for the third quarter ended September 30, 2016 and provided an update on the Company's corporate and clinical development activities.

"We plan to initiate a clinical trial evaluating evofosfamide in combination with checkpoint inhibitors with our collaborators at MD Anderson Cancer Center while at the same time continue to pursue registration of evofosfamide in Japan for the treatment of pancreatic cancer. In addition, we continue to pursue potential collaborations to expand our development pipeline while we complete IND-enabling toxicology studies with TH-3424 with the goal of reaching the clinic with a new compound in 2017," said Barry Selick, Ph.D., Chief Executive Officer of Threshold.

Recent Highlights
Evofosfamide - The Company's lead product candidate is an investigational hypoxia-activated prodrug that is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers.

Tarloxotinib - The Company had been prosecuting Phase 2 proof of concept studies with tarloxotinib, a hypoxia-activated epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), which was designed to selectively release an irreversible EGFR-TKI in hypoxic tumors.

TH-3424 - TH-3424 is the Company's small-molecule drug candidate being evaluated for the treatment of hepatocellular (liver) cancer (HCC), castrate resistant prostate cancer (CRPC), T-cell acute lymphoblastic leukemias (T-ALL), and other cancers expressing high levels of aldo-keto reductase family 1 member C3 (AKR1C3). Tumors overexpressing AKR1C3 can be resistant to radiation therapy, chemotherapy and anti-androgen therapy. TH-3424 is a prodrug that selectively releases a potent DNA cross-linking agent in the presence of AKR1C3.

Third Quarter 2016 Financial Results

About Evofosfamide
Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug of a bis-alkylating agent that is preferentially activated under severe hypoxic tumor conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

About Tarloxotinib Bromide
Tarloxotinib bromide (previously known as TH-4000), or "tarloxotinib", is a prodrug designed to selectively release a covalent (irreversible) EGFR tyrosine kinase inhibitor under severe hypoxia, a feature of many solid tumors. In September 2016, the Company announced the discontinuation of any further development of tarloxotinib.

About TH-3424
TH-3424 is small-molecule drug candidate being evaluated for the potential treatment of hepatocellular (liver) cancer (HCC), castrate resistant prostate cancer (CRPC), T-cell acute lymphoblastic leukemias (T-ALL), and other cancers expressing high levels of aldo-keto reductase family 1 member C3 (AKR1C3). Tumors overexpressing AKR1C3 can be resistant to radiation therapy and chemotherapy. TH-3424 is a prodrug that selectively releases a potent DNA cross-linking agent in the presence of AKR1C3. Preliminary nonclinical toxicology studies suggested an adequate therapeutic index that the Company believes warrants conducting Investigational New Drug (IND)-enabling toxicology studies, which are being done in collaboration with Ascenta Pharmaceuticals, Ltd.

About Threshold Pharmaceuticals

Threshold is a clinical-stage biopharmaceutical company focused on the development of drugs and diagnostic agents targeting the tumor microenvironment of solid tumors and hematologic malignancies. This approach offers broad potential to treat a variety of cancers. By selectively targeting tumor cells, we are building a pipeline of drugs that hold promise to be more effective and less toxic to healthy tissues than conventional anticancer drugs. For additional information, please visit the Company's website.

Forward-Looking Statements

Except for statements of historical fact, the statements in this press release are forward-looking statements, including all statements regarding the therapeutic potential of evofosfamide and TH-3424; Threshold's plans to focus its resources on evofosfamide and TH-3424; anticipated development activities related to evofosfamide and TH-3424, and the anticipated timing thereof; Threshold's plans to continue to pursue discussions regarding potential registration pathways for evofosfamide in Japan, and the potential for evofosfamide to be approved for marketing in Japan; and Threshold's estimates of the total and non-cash charges it expects to incur in connection with the reduction in employees, and the anticipated timing thereof. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to: the difficulty and uncertainty of pharmaceutical product development, including the risks that the design of, or data collected from, the planned Phase I clinical trial of evofosfamide with immune checkpoint inhibitors may be inadequate to demonstrate safety or sufficient efficacy, or otherwise may be insufficient to support any further development of evofosfamide, and that Threshold's toxicology studies of TH-3424 may not demonstrate sufficient safety to support an investigational new drug application and to further the development of TH-3424 into the clinic; the uncertain and time-consuming regulatory approval process, including the risk that data from the completed MAESTRO clinical trial will not be sufficient to support the approval of evofosfamide for the treatment of patients with pancreatic cancer in Japan; Threshold's need for and the availability of resources to develop evofosfamide and TH-3424 and to support Threshold's operations, including the risks that Threshold's currently-available resources may be insufficient to further current development plans for evofosfamide and TH-3424 and that Threshold will otherwise need to raise substantial additional capital in order to advance the clinical development of evofosfamide and TH-3424; the risks that Threshold could determine to abandon the development of evofosfamide and TH-3424 as a result of inadequate resources, negative or inconclusive clinical trial or toxicology study results, the failure to obtain regulatory approval of evofosfamide in Japan, or otherwise; and risks related to Threshold's ability to implement the reduction in employees as currently anticipated, the impact of such reduction on Threshold's business and unanticipated charges not currently contemplated that may occur as a result of such reduction.  Further information regarding these and other risks is included under the heading "Risk Factors" in Threshold's Quarterly Report on Form 10-Q, which has been filed with the Securities and Exchange Commission on November 7, 2016 and is available from the SEC's website (www.sec.gov) and on our website (www.thresholdpharm.com) under the heading "Investors". We undertake no duty to update any forward-looking statement made in this news release.

THRESHOLD PHARMACEUTICALS, INC.  
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 
(in thousands, except per share amounts) 
(Unaudited) 
         
         
 Three Months Ended Nine Months Ended 
 September 30, September 30, 
  2016   2015   2016   2015  
         
         
Revenue$  -   $  3,680  $   -   $  11,041  
         
Operating expenses        
  Research and development   3,521     8,081     13,542     28,902  
  General and administrative   1,716     2,372     5,857     7,468  
Total Operating Expenses   5,237     10,453     19,399     36,370  
         
  Loss from operations   (5,237)    (6,773)    (19,399)    (25,329) 
         
  Interest income (expense), net   39     27     111     99  
  Other income (expense) (1)   (498)    315     (1,124)    (661) 
Net loss$   (5,696) $   (6,431)  $ (20,412) $ (25,891 ) 
         
Net loss per common share        
Basic$   (0.08)  $   (0.09) $   (0.29)  $   (0.37) 
Diluted$   (0.08 ) $   (0.09) $   (0.29) $   (0.37) 
         
Weighted-average shares used in per common     
  share calculation:        
Basic   71,536     71,382   71,512    69,833  
Diluted   71,536      71,382   71,512   69,833  
       
(1) Noncash income (expense) related to change in the fair value of the Company's outstanding and exercised
  warrants, classified as other income (expense).   


 THRESHOLD PHARMACEUTICALS, INC.
 CONDENSED CONSOLIDATED BALANCE SHEETS
 (in thousands)
    
 September 30, December 31,
  2016     2015   
 (unaudited)    (1)  
Assets   
    
  Cash, cash equivalents and  
marketable securities$  28,110  $    48,680   
  Collaboration Receivable   400       1,891   
  Prepaid expenses and other current assets   1,022       2,599   
  Property and equipment, net   159       333   
  Other assets   -         166    
Total assets$  29,691   $    53,669    
    
Liabilities and stockholders' equity 
    
  Total current liabilities$  3,719  $    10,828   
  Long-term liabilities (2)    3,051       1,995   
  Stockholders' equity (deficit)   22,921       40,846   
  Total liabilities and stockholders' equity (deficit)$  29,691   $    53,669    
     
    
 (1)     Derived from audited financial statements
 (2)     Includes as of September 30, 2016 and December 31, 2015, $3.0 million and $1.9 million of warrant liability, respectively.


Contact:

Denise Powell

denise@redhousecomms.com

510.703.9491

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Source: Threshold Pharmaceuticals, Inc.

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