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Spring Bank Pharmaceuticals Provides Corporate Update and Reports 2016 Financial and Operational Results

HOPKINTON, Mass., Feb. 15, 2017 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. (Nasdaq:SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, cancer, and inflammatory diseases, today provided an update on recent corporate and clinical developments and reported financial results for the fourth quarter and full year ended December 31, 2016.

“Spring Bank reported a number of significant events in 2016, including financings that generated gross proceeds to us of approximately $32 million; the initiation in June 2016 of our Phase 2a ACHIEVE clinical trial involving our lead product candidate, SB 9200, an orally-available selective immunomodulator for the treatment of chronic hepatitis B virus (HBV); entering into two development partnerships for SB 9200; and advancing preclinical studies for SB 11285, our novel STING (STimulator of INterferon Genes) agonist product candidate,” said Martin Driscoll, President and Chief Executive Officer of Spring Bank Pharmaceuticals, Inc.

“More specifically, the fourth quarter of 2016 was a productive period for Spring Bank with multiple notable achievements for our company,” continued Mr. Driscoll. “In the fourth quarter of 2016, we advanced the randomization of patients in our Phase 2a clinical trial of SB 9200 for patients infected with chronic HBV, consummated two HBV development partnerships with Arrowhead Pharmaceuticals and Arbutus Biopharma, and disclosed in vitro data for our next-generation STING agonist, SB 11285. Importantly, we also completed a private placement offering which raised approximately $15 million in gross proceeds and was led by the healthcare specialist fund, MPM Capital, Oncology Impact Fund. The proceeds from this financing strengthened our balance sheet and we believe will provide the resources necessary for us to generate all the SB 9200 monotherapy dosing data from our ongoing Phase 2a trial, as well as advance SB 11285 further towards a potential IND submission in 2018,” Mr. Driscoll continued. “We have many milestones we are working towards in 2017, including our anticipated disclosure in the second quarter of 2017 of the top-line results from the first SB 9200 monotherapy dosing cohort in the Phase 2a trial of SB 9200, the potential consummation of additional development collaborations for SB 9200 in HBV, and the continued publication of preclinical data for SB 11285.”

Recent Research and Development Progress and Key Objectives

  • Continued patient enrollment in the ACHIEVE global Phase 2 clinical trial of SB 9200 in chronic HBV patients. The Phase 2a portion of the clinical trial is a placebo-controlled, sequential-cohort, double-blind trial to evaluate increasing doses of SB 9200 (25mg, 50mg, 100mg and 200mg) as a monotherapy for 12 weeks, followed by 300 mg of tenofovir disoproxil fumarate (marketed by Gilead Sciences, Inc. as Viread®) as a monotherapy for an additional 12 weeks. Spring Bank remains on track and anticipates reporting top-line results from the first SB 9200 monotherapy dosing cohort in the second quarter of 2017.
  • Consummated agreements with Arrowhead Pharmaceuticals and Arbutus Biopharma.  Spring Bank entered into an agreement to perform collaborative studies on Arrowhead's ARC-520 and Spring Bank's SB 9200, as well as an agreement to perform collaborative preclinical studies involving the co-administration of Spring Bank’s SB 9200 and Arbutus Biopharma’s AB-423, a capsid assembly inhibitor.   The preclinical study of the combination of SB 9200 and AB-423 is the first step in evaluating how a capsid assembly inhibitor can be combined with an oral immune-modulator in the treatment of chronic HBV and potentially lead to novel combination therapeutic strategies for patients with chronic HBV.  Spring Bank is encouraged by the level of industry interest, which it believes is further validation of the science behind its proprietary small molecule nucleic acid hybrid (SMNH) chemistry platform.
  • Completed Private Placement with Institutional and Other Investors.  In November 2016, Spring Bank sold 1,644,737 shares of its common stock and warrants to purchase 1,644,737 shares of common stock in a private placement, resulting in net proceeds of approximately $14 million.  Following this financing, Spring Bank anticipates that its existing cash, cash equivalents and marketable securities will be sufficient to fund the completion of its Phase 2a clinical trial of SB 9200 for patients infected with chronic HBV.
  • Two poster presentations related to pre-clinical data for SB 11285, Spring Bank’s novel next generation STING agonist, were presented by Spring Bank scientists at the AACR Special Conference on Tumor Immunology and Immunotherapy. Among the key pre-clinical findings were that SB 11285 is a highly potent STING agonist that causes the induction of Interferons (IFN), NF-KB, Interferon-stimulating genes (ISGs), cytokines, and pattern recognition receptors (PRRs). SB 11285 was also shown to cause apoptosis of multiple tumor-derived cell lines.

2016 Financial Results

  • Cash Position: Cash, cash equivalents and marketable securities were $25.5 million as of December 31, 2016, compared to cash, cash equivalents and marketable securities of $12.9 million as of December 31, 2015. Net cash used in operating activities in 2016 was $15.8 million. Spring Bank anticipates that its existing cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements at least into the third quarter of 2018. 
  • Operating Expenses: Total operating expenses for the year ended December 31, 2016 were $19.8 million, which consisted of $14.0 million of research and development (R&D) expenses and $5.7 million of general and administrative (G&A) expenses. Total operating expenses for the year ended December 31, 2015 were $12.5 million, which consisted of $7.5 million of R&D expenses and $5.0 million of G&A expenses. For the quarter ended December 31, 2016, operating expenses were $4.4 million, compared to $4.1 million for the quarter ended December 31, 2015.
  • Net loss: The company’s net loss for the year ended December 31, 2016 was $17.4 million, or $2.39 per share, compared to $11.6 million for the year ended December 31, 2015, or $2.03 per share. Net loss for the quarter ended December 31, 2016 was $2.4 million, or $0.28 per share, compared to net loss for the quarter ended December 31, 2015 of $4.0 million, or $0.68 per share.

About Spring Bank Pharmaceuticals

Spring Bank Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleic acid hybrid (SMNH) chemistry platform. SMNH compounds are small segments of nucleic acids that the company designs to selectively target and modulate the activity of specific proteins implicated in various disease states. The company is developing its most advanced SMNH product candidate, SB 9200, for the treatment of viral diseases, including hepatitis B virus (HBV). SB 9200 has been designed to selectively activate within infected cells the cellular proteins, retinoic acid-inducible gene 1, or RIG-I, and nucleotide-binding oligomerization domain-containing protein 2, or NOD2, which have been implicated in the body's immune response to viral infections. Spring Bank believes that SB 9200 may play an important role in antiviral therapy by modulating the body's immune response through its mechanisms of action to fight viral infections such as HBV. For more information, please visit www.springbankpharm.com     

Forward-Looking Statements

Any statements in this press release about Spring Bank’s future expectations, plans and prospects, including statements about (i) the company having sufficient funds to (a) complete its ongoing Phase 2a trial of SB 9200 and generate all of the SB 9200 monotherapy dosing data and (b) advance SB 11285 further towards a potential IND submission in 2018, (ii) the company having sufficient funds to enable it to fund its operating expenses and capital expenditure requirements at least into the third quarter of 2018, (iii) the company’s anticipated timeline for disclosing top-line results from the first SB 9200 monotherapy dosing cohort in the Phase 2a trial of SB 9200, (iv) the potential consummation of additional development collaborations for SB 9200 in HBV and (v) the anticipated publication of preclinical data for SB 11285, as well as any other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. 

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Spring Bank’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether Spring Bank’s product candidates will advance through the clinical trial process on a timely basis or at all; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Spring Bank’s product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the "Risk Factors" section of Spring Bank’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, which was filed with the Securities and Exchange Commission (SEC) on February 14, 2017, and in other filings Spring Bank makes with the SEC from time to time.

In addition, the forward-looking statements included in this press release represent Spring Bank’s views as of the date hereof. Spring Bank anticipates that subsequent events and developments will cause Spring Bank’s views to change. However, while Spring Bank may elect to update these forward-looking statements at some point in the future, Spring Bank specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spring Bank’s views as of any date subsequent to the date hereof.

 
Spring Bank Pharmaceuticals, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
           
    December 31,  
    2016   2015  
Cash and cash equivalents   $   10,684   $   4,347  
Short and long-term marketable securities       14,798       8,524  
Other assets       1,397       1,706  
Total assets   $   26,879   $   14,577  
           
Warrant liabilities   $   6,333   $   —  
Other liabilities       3,528       3,552  
Total liabilities       9,861       3,552  
Total stockholders’ equity       17,018       11,025  
Total liabilities and stockholders' equity   $   26,879   $   14,577  

 

Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
 
    Three Months Ended
December 31,
  Year Ended
December 31,
      2016       2015       2016       2015  
Grant revenue   $   —     $   105     $   352     $   946  
Operating expenses:                
Research and development       2,770         2,760         14,017         7,539  
General and administrative       1,603         1,308         5,739         5,003  
Total operating expenses       4,373         4,068         19,756         12,542  
Loss from operations       (4,373 )       (3,963 )       (19,404 )       (11,596 )
Interest income       31         17         96         32  
Change in fair value of warrant liabilities       1,942         —         1,942         —  
Net loss       (2,400 )       (3,946 )       (17,366 )       (11,564 )
Unrealized gain (loss) on marketable securities       (7 )       (15 )       11         (18 )
Comprehensive loss   $   (2,407 )   $   (3,961 )   $   (17,355 )   $   (11,582 )
Net loss per common share – basic and diluted   $   (0.28 )   $   (0.68 )   $   (2.39 )   $   (2.03 )
Weighted-average number of common shares used in computing net loss per share – basic and diluted       8,447,367         5,796,091         7,256,671         5,682,799  


Contact:
Spring Bank Pharmaceuticals, Inc.
Jonathan Freve
Chief Financial Officer
(508) 473-5993
jfreve@springbankpharm.com

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Spring Bank Pharmaceuticals Inc.