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Spring Bank Provides Update on Business Operations & Clinical Program Progress During COVID-19 Pandemic

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  • Pursuing collaborations to develop internal compounds for potential treatment of COVID-19

  • Safety Review Committee for IV SB 11285 Phase 1a/1b trial recommends dose escalation to next planned dose level; initial patient dosed in next cohort

  • Clinical abstracts for IV SB 11285 Phase 1a/1b trial accepted for presentation at ASCO and 7th ImmunoTherapy of Cancer Conferences

HOPKINTON, Mass., April 02, 2020 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. (NASDAQ:SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for oncology and inflammatory diseases, today provided an update on the company's business operations in response to and as a result of the global COVID-19 pandemic.

Martin Driscoll, President and Chief Executive Officer of Spring Bank, stated, "The COVID-19 pandemic has been unprecedented in the impact it has brought to the biopharmaceutical research industry and our entire global community. We are committed to the safety of our employees at Spring Bank while seeking innovative ways to continue to advance our clinical development and discovery research efforts." Mr. Driscoll continued, "We want to play a role in helping our society find effective treatments for this novel coronavirus by exploring programs and collaborations to study our internally-developed compounds as potential treatments for COVID-19. In addition, we feel fortunate that we have been able, at the current time, to continue the clinical trial for our intravenously (IV)-administered STING agonist, SB 11285, against multiple cancers."

The company has taken steps to protect the safety of its employees while working to ensure the sustainability of its business operations and development programs as the COVID-19 pandemic continues to evolve. Beginning in mid-March, Spring Bank transitioned all non-laboratory personnel to work from home. Spring Bank is continuing its business-critical laboratory activities under guidelines designed to reduce the risk of transmission of the novel coronavirus. The Company continues to assess company policies and employee support during this unprecedented time.

The Spring Bank team has also embarked on an effort to assist the global healthcare community in combating the novel coronavirus by pursuing programs and collaborations to study Spring Bank's portfolio of RIG-I agonists and compounds from its STING (STimulator of INterferon Genes) platform as potential treatments for SARS-CoV-2, the virus responsible for the COVID-19 pandemic. Dr. Radhakrishnan P. Iyer, Chief Scientific Officer & Co-Founder commented, "Our internally-developed RIG-I agonist compounds have demonstrated in vitro and in vivo activity against viral respiratory diseases such as RSV, influenza, and parainfluenza. We have previously demonstrated in in vitro and in vivo studies that our RIG-agonist compounds showed potent antiviral activity against positive-strand RNA viruses such as Norovirus and Hepatitis C (HCV)." Dr. Iyer continued, "Positive-strand RNA viruses are characterized by genetic material which consists of a positive (or sense) RNA strand which encodes mRNA (messenger RNA) for viral protein production. We believe our previous work in this area will be important in informing us about the potential role of our RIG-I agonist and STING compounds in the treatment of SARS-CoV-2 because this pathogen is also a positive-strand RNA virus. We are exploring the optimal ways to advance the research and potential use of our compounds against SARS-CoV-2."

SB 11285 is currently being evaluated as an IV-administered monotherapy in a Phase 1a/1b multicenter, dose escalation clinical trial in patients with advanced solid tumors. The Safety Review Committee for the IV SB 11285 Phase 1a/1b clinical trial has recommended dose escalation to the next planned cohort in the trial and principal investigators have initiated dosing of this cohort at the next higher monotherapy dose level. Although a few of the institutions involved in the conduct of this trial have suspended patient enrollment in all clinical trials due to the current pandemic, the Spring Bank Clinical Development team has been able to continue dosing patients in this trial at a key site. The Spring Bank Clinical Development team will continue to closely monitor the impact of the COVID-19 pandemic on the healthcare institutions currently involved in the IV SB 11285 Phase 1a/1b trial and take appropriate action with the conduct of the trial, if necessary, per the recent FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic. While the company anticipates the Phase 1a/1b trial will remain open and currently enrolled patients will continue on study, clinical sites may determine to stop enrolling and/or dosing patients as a result of the impact of the COVID-19 pandemic, which has the potential to impact the availability of data in 2020.

"We are pleased that the Safety Review Committee for our IV SB 11285 Phase 1a/1b has recommended the dose escalation in our ongoing study and we have proceeded to the dosing of the first patient in the next planned higher dose level," said Atif Abbas, M.D., Vice President, Immuno-Oncology Clinical Development at Spring Bank. Dr. Abbas continued, "We will soon submit protocol amendments for this trial that include the use of Roche's PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) in the next arm of the trial as we implement our recently-announced clinical collaboration with Roche. We were also excited to receive the recent news that abstracts related to our IV SB 11285 Phase 1a/1b trial have been accepted for poster presentation at the 2020 ASCO Annual Meeting in Washington, D.C. and the 7th ImmunoTherapy of Cancer (ITOC7) conference in Munich."

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
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, about Spring Bank's future expectations, plans and prospects. These statements include, but are not limited to, statements about expected plans and timing of exploring and pursuing collaborations to develop the company's internal compounds for potential treatment of COVID-19 and the company's Phase 1a/1b clinical trial for SB 11285 and the continued dosing of patients in, and the timing of availability of data from, this trial. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "will," "would," "could," "potential," "possible," "hope," "likelihood" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to: Spring Bank's ability to successfully demonstrate the safety and efficacy of its product candidates; any delay of any current or planned non-clinical or clinical trials or the development of any product candidate, including any delays relating to clinical sites stopping enrolling and/or dosing patients; 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 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, 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 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 after the date hereof.

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

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

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