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Sunesis Pharmaceuticals Reports Third Quarter 2018 Financial Results and Recent Highlights

11/05/18

Sunesis to Host Conference Call Today at 4:30 PM Eastern Time

SOUTH SAN FRANCISCO, Calif., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for the quarter ended September 30, 2018. Loss from operations for the three and nine months ended September 30, 2018 was $6.3 million and $20.0 million. As of September 30, 2018, cash and cash equivalents totaled $20.2 million. This capital is expected to fund the company into the second quarter of 2019.

“We remain focused on advancing our non-covalent BTK inhibitor vecabrutinib to help patients who have developed resistance to covalent BTK inhibitors such as ibrutinib,” said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. “We continue to learn more about this unique asset and its market opportunity and will share an update at the ASH Annual Meeting in December. As announced last week, one of our accepted abstracts for presentation at ASH includes an update on the Phase 1b/2 trial of vecabrutinib, and as presented in the published abstract, the pharmacokinetic profile is consistent with the results from our Phase 1a study. We continue to believe that 100mg to 300mg will be the potentially active dose levels. Thus far, vecabrutinib appears well tolerated in the context of advanced disease. We continue with the dose escalation part of the trial and look forward to sharing a complete clinical update at the meeting next month and at a company-sponsored webcast event concurrent with the meeting.”

Recent Highlights

Financial Highlights

  • Cash and cash equivalents totaled $20.2 million as of September 30, 2018, as compared to $31.8 million in cash, cash equivalents, and marketable securities as of December 31, 2017. This capital is expected to fund the company into the second quarter of 2019. The nine-month decrease of $11.6 million was primarily due to $17.9 million of net cash used in operating activities, partially offset by $6.3 million in net cash flows from financing activities.

  • Research and development expense was $3.6 million and $11.3 million for the three and nine months ended September 30, 2018, as compared to $6.8 million and $17.9 million for the same periods in 2017, primarily relating to the vecabrutinib and the vosaroxin development program in each period. The decreases of $3.2 million and $6.6 million between the comparable periods from last year was primarily due to a $2.5 million milestone payment made during the third quarter of 2017 to Biogen under the license agreement, a decrease in salary and personnel expenses, a decrease in professional services, and clinical trial expenses related to higher expenses incurred in 2017 due to the MAA with the EMA.

  • General and administrative expense was $2.7 million and $8.9 million for the three and nine months ended September 30, 2018, as compared to $3.2 million and $10.8 million for the same periods in 2017. The decreases of $0.5 million and $1.9 million between the comparable periods in 2017 were primarily due to reduced professional services, personnel, and commercial expenses.

  • Interest expense was $0.3 million and $0.9 million for the three and nine months ended September 30, 2018, as compared to $0.3 million and $1.1 million for the same periods in 2017. The decrease during the nine months period was primarily due to the decrease in the outstanding notes payable.

  • Cash used in operating activities was $17.9 million for the nine months ended September 30, 2018, as compared to $30.8 million for the same period in 2017. Net cash used in the 2018 periods resulted primarily from the net loss of $20.6 million, partly offset by net adjustments for non-cash items of $2.3 million and changes in operating assets and liabilities of $0.4 million. Net cash used in the 2017 period resulted primarily from the net loss of $28.8 million and changes in operating assets and liabilities of $4.6 million, partly offset by net adjustments for non-cash items of $2.6 million.

  • Loss from operations was $6.3 million and $20.0 million for the three and nine months ended September 30, 2018, as compared to $9.9 million and $28.0 million for the same periods in 2017.  Net loss was $6.5 million and $20.6 million for the three and nine months ended September 30, 2018, as compared to $10.2 million and $28.8 million for the same periods in 2017.

Conference Call Information

Sunesis will host a conference today at 4:30 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 5971729. To access the live audio webcast, or the subsequent archived recording, visit the “Investors and Media – Calendar of Events” section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

About Sunesis Pharmaceuticals

Sunesis is a biopharmaceutical company developing new therapeutics for the treatment of hematologic and solid cancers. Sunesis has built an experienced drug development organization committed to improving the lives of people with cancer. The Company is focused on advancing its novel kinase inhibitor pipeline, with an emphasis on its oral non-covalent BTK inhibitor vecabrutinib. Vecabrutinib is currently being evaluated in a Phase 1b/2 study in adults with chronic lymphocytic leukemia and other B-cell malignancies that have progressed after prior therapies. The Company’s proprietary PDK1 inhibitor SNS-510 is in preclinical development. PDK1 is a master kinase that activates other kinases important to cell growth and survival including members of the AKT, PKC, RSK, and SGK families. Sunesis plans to submit an IND for SNS-510 in 2019. Sunesis is exploring strategic alternatives for vosaroxin, a late-stage investigational product for relapsed or refractory AML. Sunesis also has an interest in the pan-RAF inhibitor TAK-580 which is licensed to Takeda. TAK-580 is in a clinical trial for pediatric low-grade glioma.

For additional information on Sunesis, please visit www.sunesis.com.

SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.

This press release contains forward-looking statements, including statements related to Sunesis’ cash sufficiency forecast, the continued development of vecabrutinib (SNS-062), including the timing of Phase 1b/2 trial of vecabrutinib and the therapeutic potential of vecabrutinib, further development and potential of its kinase inhibitor pipeline, and planned development of SNS-510 and TAK-580. Words such as “expect,” “look forward,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risk related to the timing or conduct of Sunesis' clinical trials, including the vecabrutinib Phase 1b/2 trial, the risk that Sunesis' clinical or preclinical studies for vecabrutinib, SNS-510 or other product candidate may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, risks related to the timing or conduct of Sunesis' clinical trials, that Sunesis' development activities for vecabrutinib or SNS-510 could be otherwise halted or significantly delayed for various reasons, that Sunesis may not be able to receive regulatory approval of vecabrutinib, or SNS-510 in the U.S. or Europe, and risks related to Sunesis' ability to raise the capital that it believes to be accessible and is required to fully finance the development and commercialization of vecabrutinib, SNS-510 and other product candidates. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2018 and Sunesis' other filings with the Securities and Exchange Commission.  Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein reflect any change in Sunesis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.


SUNESIS PHARMACEUTICALS, INC.  
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS  
AND COMPREHENSIVE LOSS  
(In thousands, except per share amounts)  
                                 
    Three months ended
September 30,
    Nine months ended
September 30,
 
    2018     2017     2018     2017  
    (Unaudited)     (Unaudited)     (Unaudited)     (Unaudited)  
Revenue:                                
License and other revenue   $ -     $ -     $ 237     $ 669  
Total revenues     -       -       237       669  
Operating expenses:                                
Research and development     3,587       6,763       11,314       17,866  
General and administrative     2,690       3,175       8,873       10,788  
Total operating expenses     6,277       9,938       20,187       28,654  
Loss from operations     (6,277 )     (9,938 )     (19,950 )     (27,985 )
Interest expense     (291 )     (288 )     (859 )     (1,116 )
Other income, net     63       67       191       266  
Net loss     (6,505 )     (10,159 )     (20,618 )     (28,835 )
Unrealized gain on available-for-sale securities     1       8       7       21  
Comprehensive loss   $ (6,504 )   $ (10,151 )   $ (20,611 )   $ (28,814 )
Basic and diluted loss per common share:                                
Net loss   $ (6,505 )   $ (10,159 )   $ (20,618 )   $ (28,835 )
Shares used in computing basic and diluted
  loss per common share
    36,095       23,678       34,956       22,106  
Basic and diluted loss per common share   $ (0.18 )   $ (0.43 )   $ (0.59 )   $ (1.30 )


SUNESIS PHARMACEUTICALS, INC.  
CONDENSED CONSOLIDATED BALANCE SHEETS  
(In thousands)  
                 
    September 30,     December 31,  
    2018     2017  
    (Unaudited)     (1)  
ASSETS                
Current assets:                
Cash and cash equivalents   $ 20,162     $ 26,977  
Marketable securities     -       4,773  
Prepaids and other current assets     1,302       1,183  
Total current assets     21,464       32,933  
Property and equipment, net     14       20  
Deposits and other assets     108       1,381  
Total assets   $ 21,586     $ 34,334  
LIABILITIES AND STOCKHOLDERS EQUITY                
Current liabilities:                
Accounts payable   $ 1,277     $ 1,697  
Accrued clinical expense     644       767  
Accrued compensation     1,186       1,440  
Other accrued liabilities     1,831       1,570  
Notes payable     7,348       7,204  
Total current liabilities     12,286       12,678  
Other liabilities     4       112  
Total liabilities     12,290       12,790  
Commitments and contingencies                
Stockholders’ equity:                
Preferred stock     20,966       20,966  
Common stock     4       3  
Additional paid-in capital     641,798       633,436  
Accumulated other comprehensive loss     -       (7 )
Accumulated deficit     (653,472 )     (632,854 )
Total stockholders’ equity     9,296       21,544  
Total liabilities and stockholders’ equity   $ 21,586     $ 34,334  
                 
Note 1:  The consolidated balance sheet as of December 31, 2017 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2017.  

 

Investor and Media Inquiries:
Maeve Conneighton
Argot Partners
212-600-1902
 

Willie Quinn
Sunesis Pharmaceuticals Inc.
650-266-3716

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Source: Sunesis Pharmaceuticals, Inc.