Spring Bank Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full-Year 2017 Financial and Operational Results

2017 highlighted by continued progress with global inarigivir clinical program for the treatment of chronic HBV and advancement of next-generation STING agonist candidate, SB 11285, towards the clinic

Multiple potential development catalysts and data read-outs expected in 2018

HOPKINTON, Mass., Feb. 20, 2018 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. (Nasdaq:SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, today announced its fourth quarter and full-year 2017 financial results and provided an update on recent developments.

“In 2017, we significantly advanced the development of both our RIG-I and STING platforms, entered into strategic partnerships and strengthened our balance sheet,” commented Martin Driscoll, president and chief executive officer of Spring Bank Pharmaceuticals. “With the positive initial top-line results announced from the ongoing Phase 2 ACHIEVE trial for our lead development candidate, inarigivir, we now have the most advanced clinical candidate for chronic hepatitis B and are excited to continue to lead the way in the development of a potential simple, safe and selective functional cure for this disease. We are also encouraged by the preclinical results for our next-generation STING agonist candidate, SB 11285, which lead us to believe that SB 11285 has the potential to be clinically administered intratumorally and intravenously for a variety of tumors at various anatomic sites. Our execution during 2017 has set the stage for what we believe could be a productive 2018 with numerous potential development catalysts.”

Mr. Driscoll continued, “We have multiple objectives that we are working towards in 2018. Our primary objective is to further advance our inarigivir global clinical development program, particularly our clinical trial collaboration with Gilead involving the co-administration of inarigivir with Gilead’s oral antiviral agents, tenofovir disoproxil fumarate (marketed by Gilead as Viread®) and tenofovir alafenamide (marketed by Gilead as Vemlidy®). We will continue to execute our broad inarigivir clinical development program by (1) completing the Part A monotherapy dose-finding segment of the ACHIEVE trial, (2) conducting additional formulation development work for SB 9225, our potential fixed-dose co-formulation product combining inarigivir with tenofovir disoproxil fumarate, and (3) pursuing additional combinatorial or “triplet” therapies combining inarigivir, an oral antiviral agent and/or a potential third product or product candidate with a differing mechanism of action. Depending on the results of the ACHIEVE study and additional co-administration clinical trials that we are conducting, it is our objective to enter into a global Phase 3 program with inarigivir in 2019. Finally, we plan to initiate a Phase 1b/2 clinical trial with our novel, next-generation STING agonist, SB 11285, in hepatocellular carcinoma late in the second half of 2018.”

Potential 2018 Milestones

• Complete Part A inarigivir monotherapy segment of the ACHIEVE trial by end of 2018
  • The company remains on track to release top-line results from the third monotherapy cohort (100mg) of the ACHIEVE trial in mid-2018 and top-line results from the fourth monotherapy cohort (200mg) in late 2018.
• Report data from the co-administration clinical trials of inarigivir with the oral antiviral agents Viread and/or Vemlidy
  • The company entered into a clinical supply and collaboration agreement with Gilead under which Gilead is funding and conducting a Phase 2 trial examining the co-administration of inarigivir (50mg) and Vemlidy in patients infected with chronic HBV. Gilead has initiated this clinical trial in Korea. Spring Bank anticipates interim results from this trial in the second half of 2018.
  • Spring Bank currently intends to initiate Part B of the ACHIEVE trial in mid-2018 to evaluate the co-administration of inarigivir (100mg) with Viread.
• Continue to advance the development of SB 9225 (inarigivir + tenofovir disoproxil fumarate)
  • Spring Bank has conducted development work that indicates inarigivir and tenofovir disoproxil fumarate are compatible in the same formulation. The company is conducting additional formulation development work for SB 9225 with the objective to potentially include this fixed-dose combination product candidate in Phase 3 clinical trial(s) in 2019.
• Advance the company’s proprietary, novel next-generation STING agonist candidate, SB 11285, into the clinic
  • The company plans to submit a clinical trial application for SB 11285 in the second half of 2018, and, if approved, initiate a Phase 1b/2 clinical trial in hepatocellular carcinoma later in the second half of 2018.
• Explore additional strategic partnerships
  • The company plans to pursue additional HBV clinical trial collaboration opportunities, including a combinatorial or “triplet” therapy combining inarigivir, an oral antiviral agent and/or a potential third product or product candidate with a differing mechanism of action, such as a capsid inhibitor or siRNA compound.
    
  • Due to the substantial prevalence of chronic HBV and regulatory changes in China, the company plans to further examine strategic opportunities in that region.
• Expand the Spring Bank STING agonist platform
  
  • The company is exploring additional delivery methods for its STING agonist platform, including nanoparticle formulations as well as further development of antibody-drug conjugates to be used with the company’s STING agonist product candidates.

2017 and Other Recent Accomplishments

• Continued progress in the execution of the global Phase 2 ACHIEVE clinical trial for inarigivir in hepatitis B.
  • The first three cohorts of Part A of the ACHIEVE trial have been enrolled on a timely basis and Spring Bank remains on track to report top-line results for the third monotherapy cohort (100mg) in mid-2018. In March 2018, our chief medical officer, Nezam Afdhal, M.D., D.Sc., will be giving an oral presentation highlighting the combined results from the first two cohorts of Part A of the ACHIEVE trial, including the sequential Viread 12-week dosing period, at the Asian Pacific Association for the Study of the Liver (APASL) 2018 Annual Meeting (March 14-18, 2018). In April 2018, Professor Stephen Locarnini, the Principal Investigator of the Virology Core for the ACHIEVE trial and the Head, Research & Molecular Development, Victorian Infectious Diseases Reference Laboratory, will present additional virology results from the combined first two cohorts of Part A of the ACHIEVE trial, including the sequential Viread 12-week dosing period in an oral presentation at The European Association for the Study of the Liver (EASL) 2018 Annual Meeting (April 11-15, 2018). Also at EASL, Prof. Dr. Man-Fung Yuen, Principal Investigator of the ACHIEVE trial and Chair Professor of Gastroenterology and Hepatology, Li Shu Fan Medical Foundation Professor in Medicine, the University of Hong Kong, will deliver a poster presentation describing clinical results from the combined first two cohorts of Part A of the ACHIEVE trial.
    
  • Spring Bank advanced the development of SB 9225, a fixed-dose co-formulation product candidate combining inarigivir with tenofovir disoproxil fumarate.
    
• Advanced SB 11285 for immuno-oncology
  
  • The company presented data from multiple preclinical studies that demonstrated SB 11285 as a highly potent anti-tumor agent with a durable anti-tumor response when administered by multiple routes in several tumor models. 
    
  • Spring Bank initiated the IND-enabling toxicology program for SB 11285.
    
  • Spring Bank consummated an Evaluation Assessment Agreement with a major Antibody Drug Conjugate (ADC) biopharmaceutical company to examine the potential to conjugate the Spring Bank STING agonist compounds with proprietary antibodies for oncology.
    
  • Four Patent Cooperation Treaty (PCT) applications were published in January 2018 by the U.S. Patent and Trademark Office covering the Spring Bank STING agonist platform program.
    
    
• Strengthened the balance sheet and extended the runway for the Company late into 2019 with financing activities that raised a total of $47M in 2017
  
  
• Strengthened the board of directors with the addition of Christiana Bardon, M.D., one of the leading investors in the life sciences industry who has extensive expertise in the biopharma sector

Year-End and Fourth Quarter 2017 Financial Results

• Cash Position: Cash, cash equivalents and marketable securities were $50.6 million as of December 31, 2017, compared to cash, cash equivalents and marketable securities of $25.5 million as of December 31, 2016. Net cash used in operating activities for the twelve months ended December 31, 2017 was $17.7 million, compared to $15.8 million for the same period in 2016. Spring Bank expects that its cash, cash equivalents and marketable securities as of December 31, 2017 will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2019, but will not be sufficient to fund the initiation of any Phase 3 trial for inarigivir, which could occur earlier than the fourth quarter of 2019. 
  
  
• Operating Expenses: Total operating expenses for the year ended December 31, 2017 were $21.3 million, which consisted of $13.1 million of research and development (R&D) expenses and $8.2 million of general and administrative (G&A) expenses. Total operating expenses for the year ended December 31, 2016 were $19.8 million, which consisted of $14.0 million of R&D expenses and $5.8 million of G&A expenses. For the quarter ended December 31, 2017, operating expenses were $6.3 million, compared to $4.4 million for the quarter ended December 31, 2016.
  
  
• Net loss: The company’s net loss for the year ended December 31, 2017 was $(27.7) million, or $(2.48) per share, compared to $(17.4) million for the year ended December 31, 2016, or $(2.39) per share. Net loss for the quarter ended December 31, 2017 was $(1.5) million, or $(0.11) per share, compared to net loss for the quarter ended December 31, 2016 of $(2.4) million, or $(0.28) per share.

Conference Call
Spring Bank will host a conference call and webcast at 8:30 a.m. EST tomorrow, Wednesday, February 21, 2018, to discuss its 2017 results and objectives for 2018. The conference call may be accessed by dialing (800) 289-0517 for U.S. callers and (323) 794-2423 for international callers and providing the conference ID 5789868. Additionally, a live, listen-only webcast of the conference call can be accessed by visiting the Investors & Media section of the company’s website at www.springbankpharm.com or by clicking here.  

A replay of the conference call will be available until March 7, 2018 by dialing 844-512-2921 for U.S. callers and 412-317-6671 for international callers and providing the conference ID 5789868.

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, inarigivir soproxil for the treatment of viral diseases, including hepatitis B virus (HBV) and other SMNH product candidates, including SB 11285, the company's lead immunotherapeutic agent for the treatment of selected cancers through the activation of the STimulator of Interferon Genes, or STING, pathway. For more information, please visit www.springbankpharm.com.

Forward-Looking Statements
Statements in this press release about Spring Bank's future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about (i) the company’s general objectives and anticipated timing for achieving those objectives, including, but not limited to, (a) the company’s anticipated timeline for disclosing additional results from the Phase 2 ACHIEVE trial and the Phase 2 trial combining inarigivir and Vemlidy that is being conducted by Gilead, (b) the company’s objective to initiate a Phase 3 trial for inarigivir in 2019, and (c) the anticipated timeline for submitting a CTA and conducting clinical trials for SB 11285; (ii) the company having sufficient funds to enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2019.

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 year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 20, 2018, 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.

Contacts

For investor inquires:
Spring Bank Pharmaceuticals, Inc.
Jonathan Freve
Chief Financial Officer
(508) 473-5993

LifeSci Advisors, LLC
Andrew McDonald, Ph.D.
(646) 597-6987
Andrew@lifesciadvisors.com

Media contact:
Mike Tattory
LifeSci Public Relations
(646) 751-4362
mtattory@lifescipublicrelations.com