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Spring Bank Pharmaceuticals Reports First Quarter 2020 Financial and Operational Results

Continues to advance IV SB 11285 clinical trial to additional dosing cohorts

On track to include Roche’s Tecentriq® in IV SB 11285 clinical trial in summer 2020

Advancing efforts to examine RIG-I and STING agonists portfolio as potential therapeutics and/or vaccine adjuvants for COVID-19

HOPKINTON, Mass., May 07, 2020 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of certain cancers and inflammatory diseases, today announced its financial results for the first quarter ended March 31, 2020 and provided an update on recent corporate and clinical development highlights.

“Despite the negative impact of the COVID-19 pandemic on the conduct of clinical trials throughout our industry, we have been fortunate to find ways to continue to dose patients in our SB 11285 Phase 1a/1b trial through the exceptional efforts of our principal investigator and the Spring Bank team,” stated Martin Driscoll, President and Chief Executive Officer of Spring Bank. “We are advancing our novel intravenously (IV)-administered SB 11285 compound through the monotherapy dose escalation phase and could be in a position to initiate the combination treatment phase with Roche’s Tecentriq® (atezolizumab) this summer. We currently remain on track to generate clinical data for IV SB 11285 later this year.”

Mr. Driscoll continued, “Our R&D team continues to progress our novel STING antagonist program with the goal to advance a lead orally-available compound into IND-enabling activities by the end of this year. Our team is also working to select a lead STING agonist antibody-drug conjugate (ADC) program that we will advance into IND-enabling efforts in 2021. With the implementation of our recent cost-management efforts, we have the resources to fund the ongoing IV SB 11285 clinical program and our R&D efforts through the first quarter of 2022.”

Dr. Radhakrishnan P. Iyer, Chief Scientific Officer and Co-Founder of Spring Bank, also commented, “We are exploring the potential use of our portfolio of RIG-I agonist and STING agonist compounds as therapeutics and vaccine adjuvants for SARS-CoV-2, the virus responsible for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID) is currently testing multiple compounds from our portfolio of RIG-I agonists and STING agonists in the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) assay, and we have been notified by NIAID that certain of our compounds have been selected for evaluation of antiviral activity in the SARS-CoV-2 antiviral assay this summer. We are also pursuing the inclusion of inarigivir soproxil, a RIG-I agonist, as an adjuvant therapy in ongoing clinical trials involving Bacille Calmette-Guerin (BCG) vaccines against SARS-CoV-2. In preclinical studies, inarigivir was shown to be a potent adjuvant that potentiates the prophylactic activity of BCG against Mycobacterium tuberculosis, the agent that causes tuberculosis.”

Recent Highlights and Business Developments

  • Continued Advancement of IV SB 11285 Phase 1a/1b Clinical Trial. In the fourth quarter of 2019, Spring Bank initiated dosing of patients with advanced solid tumors in the monotherapy arm of its Phase 1a/1b trial of SB 11285, Spring Bank’s intravenously (IV)-administered STING agonist development candidate. In April 2020, the company announced that the Safety Review Committee for this trial recommended dose escalation to the next planned monotherapy cohort in the trial. Following this recommendation, one of the company’s principal investigators started dosing patients at the next higher monotherapy dose level. Although several of the institutions involved in the conduct of this trial have suspended patient enrollment in all of their clinical trials due to the COVID-19 pandemic, Spring Bank has been able to continue dosing patients in this trial at a key site. Depending on whether the company is able to continue enrolling and dosing patients in this trial, the company plans to generate sufficient data from its Phase 1a/1b IV STING agonist program by the end of 2020 to enable advancement into a Phase 2 clinical trial.
  • Received Confirmation for Participation in Upcoming Scientific Conferences. The company has been informed that abstracts related to its IV SB 11285 Phase 1a/1b trial have been accepted for poster presentation at the 2020 ASCO Annual Meeting from May 29-31, 2020 and the 7th ImmunoTherapy of Cancer (ITOC7) conference from October 3-5, 2020.
  • Entered into Clinical Collaboration with Roche to Explore Co-Administration of IV SB 11285 and Tecentriq (atezolizumab). In February 2020, Spring Bank entered into a clinical trial supply agreement with Roche to explore the co-administration of IV SB 11285 with Roche’s PD-L1 checkpoint inhibitor Tecentriq in the Phase 1a/1b trial. The company hopes to be in a position to initiate the first combination cohort in this trial examining the co-administration of IV SB 11285 and Tecentriq this summer.
  • Advanced Efforts to Examine RIG-I and STING Agonists for COVID-19. In April 2020, the company announced that it embarked on an effort to pursue programs and collaborations to study Spring Bank’s portfolio of RIG-I agonist and STING agonist compounds as potential treatments for SARS-CoV-2, the virus responsible for COVID-19. The company is collaborating with the NIAID to examine multiple compounds from its RIG-I agonist and STING agonist portfolio in the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) assay and the SARS-CoV-2 antiviral assay. The company is also pursuing the inclusion of inarigivir as an adjuvant therapy in ongoing clinical trials involving BCG vaccines.
  • Repaid Convertible Term Loan. In September 2019, Spring Bank entered into a $20 million convertible debt financing agreement with an affiliate of Pontifax Ltd., a healthcare-dedicated venture capital firm. On April 8, 2020, Spring Bank repaid in full this convertible term loan. The company made the decision to repay this loan as a result of changes in its operating needs following its announcement in the first quarter of 2020 that it would discontinue the development of its hepatitis B virus (HBV) program, as well as the cost of capital associated with the loan.

2020 First Quarter Financial Results

  • Cash Position: Cash, cash equivalents and marketable securities were $47.5 million as of March 31, 2020, compared to cash, cash equivalents and marketable securities of $54.5 million as of December 31, 2019. Net cash used in operating activities for the three months ended March 31, 2020 was $7.2 million, compared to $6.8 million for the same period in 2019. On April 8, 2020, Spring Bank used approximately $20.3 million to fund the repayment in full of the Company’s then outstanding convertible term loan. Following the full repayment of the loan, Spring Bank expects that its cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements through the first quarter of 2022.
  • Operating Expenses: Total operating expenses for the three months ended March 31, 2020 were $8.2 million, which consisted of $5.3 million of research and development (R&D) expenses and $2.9 million of general and administrative (G&A) expenses, compared to total operating expenses of $8.4 million, which consisted of $5.6 million of research and development (R&D) expenses and $2.8 million of general and administrative (G&A) expenses for the three months ended March 31, 2019.
  • Net loss: The company’s net loss for the three months ended March 31, 2020 was $8.2 million, or $0.49 per basic and diluted share, compared to net loss for the three months ended March 31, 2019 of $5.2 million, or $0.32 per basic and diluted share.

About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleotide platform. The company designs its compounds to selectively target and modulate the activity of specific proteins implicated in various disease states. The company is developing its STING product portfolio with its lead clinical product candidate, SB 11285, an intravenously-administered immunotherapeutic agent for the treatment of selected cancers, its STING antagonist compounds for the treatment of a broad range of inflammatory diseases and its STING agonist ADC program for potential oncology applications. 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 the company having sufficient funds to enable it to fund its operating expenses and capital expenditure requirements through the first quarter of 2022, the company’s expected timelines for its Phase 1 clinical trial for SB 11285, the company’s plans to initiate IND-enabling activities for its preclinical programs and the company’s expectations for testing its compounds for activity against SARS-CoV-2.

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 product candidates will advance through the clinical trial process on a timely basis, or at all; whether Spring Bank’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether the results of the company’s trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; the impact of the COVID-19 pandemic on anticipated timelines; 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, 2019, which was filed with the Securities and Exchange Commission (SEC) on February 14, 2020 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 could 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.

Investors:

LifeSci Advisors, LLC
Ashley R. Robinson
(617) 535-7742
Ashley@lifesciadvisors.com

Media:
McNeil, Gray & Rice
Kristin Nugent
Senior Account Supervisor
(617) 367-0100

Source: Spring Bank Pharmaceuticals, Inc.



SPRING BANK PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)

  March 31,     December 31,
  2020     2019
  (unaudited)      
Cash and cash equivalents $ 30,633     $ 28,709  
Short and long-term marketable securities   16,873       25,746  
Operating lease right-of-use assets   2,648       2,717  
Other assets   5,370       6,025  
Total assets $ 55,524     $ 63,197  
         
Term loan, net of unamortized discount, current $ 19,147     $  
Term loan, net of unamortized discount, noncurrent         19,070  
Warrant liabilities   60       299  
Other liabilities   5,271       5,433  
Operating lease liabilities, noncurrent   2,774       2,869  
Total liabilities   27,252       27,671  
Total stockholders’ equity   28,272       35,526  
Total liabilities and stockholders' equity $ 55,524     $ 63,197  
         



SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(unaudited)

  For the Three Months Ended
March 31,
    2020       2019  
Operating expenses:      
Research and development $ 5,303     $ 5,567  
General and administrative   2,879       2,810  
Total operating expenses   8,182       8,377  
Loss from operations   (8,182 )     (8,377 )
Other income (expense):      
Interest income   241       361  
Interest expense   (476 )      
Change in fair value of warrant liabilities   239       2,821  
Net loss   (8,178 )     (5,195 )
Unrealized gain/(loss) on marketable securities   77       (116 )
Comprehensive Loss $ (8,101 )   $ (5,311 )
Net loss per common share - basic and diluted $ (0.49 )   $ (0.32 )
Weighted-average number of shares outstanding - basic and diluted   16,523,750       16,436,970  
       

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Source: Spring Bank Pharmaceuticals, Inc.