Spring Bank Pharmaceuticals Reports Third Quarter 2019 Financial and Operational Results and Provides Corporate Update

HOPKINTON, Mass., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. SBPH, a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, today announced its financial results for the third quarter ended September 30, 2019 and provided an update on recent corporate and clinical development advances.

"Our team at Spring Bank delivered a solid performance in the execution of our key programs in the third quarter of this year," said Martin Driscoll, Chief Executive Officer at Spring Bank. "We are now operating two clinical programs in chronic HBV and immuno-oncology including a total of five clinical studies for inarigivir and SB 11285. Based on recent positive data from our non-clinical program for SB 527, our novel proprietary chimeric antisense oligonucleotide compound linked with inarigivir, we are investing more resources in our efforts to advance this program into the clinic in late 2020. As a company, we are executing on our plan to deliver multiple data readouts from our chronic HBV and immuno-oncology programs throughout 2020."

"We extended our cash runway into 2022 with the completion of our previously announced convertible debt facility," said Jonathan Freve, Chief Financial Officer at Spring Bank. "Our efficient management of operations together with a strengthened balance sheet will allow us to execute our clinical development plans with multiple potential catalysts to be announced over the next 12 months."

Recent Highlights and Business Developments

• Released Interim 12-Week Top-Line Results from First Cohort of the Low-Dose Inarigivir 50mg in the Gilead Sciences' Inarigivir Plus Vemlidy Phase 2 Trial. In October, the company announced interim top-line results at 12 weeks from the first cohort of the ongoing Phase 2 trial evaluating the safety, efficacy and pharmacodynamics of escalating doses (50mg, 200mg and 400mg) of inarigivir co-administered with Gilead Sciences' Vemlidy® (tenofovir alafenamide 25mg) for the treatment of chronic hepatitis B virus (HBV) infection. At week 12, 7 of the 30 patients (23%) in the inarigivir 50mg plus Vemlidy arm were HBsAg responders and met the primary efficacy study endpoint of having greater than or equal to 0.5 log₁₀ IU/mL reduction in hepatitis B surface antigen (HBsAg) from baseline. This result of 7 of 30 patients (23%) observed as HBsAg responders when dosed for 12 weeks with the low dose of inarigivir 50mg plus Vemlidy compares favorably with the experience from the company's ACHIEVE Trial where 1 of 14 patients (7%) was an HBsAg responder when dosed with inarigivir 50mg monotherapy for 12 weeks. This was the first data from a clinical trial examining the co-administration of inarigivir with a nucleos(t)ide analog (NUC) in chronic HBV patients. Further analysis of the low dose cohort and evaluation of the safety, efficacy and pharmacodynamics of escalating doses of inarigivir (200mg and 400mg) co-administered with Vemlidy in HBV patients are ongoing. Interim top-line results from the remaining cohorts of the trial are expected in 2020.
   
• Initiated Dosing in Multiple Global Phase 2b Trials with Inarigivir 400mg. Spring Bank's Phase 2 HBV clinical development program is designed to demonstrate the likelihood of functional cure in both HBV treatment-naïve and virally-suppressed patients already on NUC treatment in the CATALYST 1 and CATALYST 2 trials. The company initiated dosing of patients with inarigivir 400mg in three significant trials: (1) the CATALYST 1 trial, examining inarigivir 400mg monotherapy and co-administration of inarigivir 400mg with a NUC in treatment-naïve patients, (2) the CATALYST 2 trial, examining the administration of inarigivir 400mg in NUC-suppressed chronic HBV patients, and (3) a unique liver biopsy study examining paired liver biopsies in HBV patients before treatment and on treatment with inarigivir to identify the interaction of inarigivir 400mg with the intrahepatic immune system and its effect on cccDNA. The company anticipates presenting initial results from these studies throughout 2020.
   
• Initiated the SB 11285 Phase 1a/1b Trial. The company initiated the Phase 1 trial of SB 11285, Spring Bank's intravenously (IV)-administered STING agonist development candidate. The Phase 1 trial aims to evaluate the safety, tolerability and initial anti-tumor activity of IV SB 11285 in patients with advanced solid tumors. Results from this trial are expected in 2020.
   
• Yale Cancer Center Presented on Combination of SB 11285 and Radiation Therapy. In September, Dr. Thomas Hayman, MD, Ph.D., from the Department of Therapeutic Radiology at Yale Cancer Center, presented results from a study evaluating the activation of the STimulator of INterferon Genes (STING) pathway using SB 11285 in combination with radiation therapy. The results demonstrated that the addition of IV SB 11285 to radiation therapy enhanced effectiveness in killing tumors vs. radiation alone in pre-clinical models. The addition of IV SB 11285 showed a synergistic effect in shrinking tumors when combined with radiation in xenograft models of head and neck tumors in mice.
   
• Advanced the Development of an HBV CASO Program in Collaboration with the National Institutes of Health (NIH). In July, Spring Bank announced its entry into a research agreement with The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, to evaluate the company's novel chimeric antisense oligonucleotide compounds (CASOs) for the treatment of chronic HBV.
   
• Initiated a Collaboration with University of Texas Southwestern Medical School (UTSW) for the Advancement of Spring Bank STING Antagonist Compound. In August, Spring Bank entered into an agreement with UTSW to evaluate the company's novel small molecule STING antagonist compounds. UTSW's Dr. Nan Yan, as Principal Investigator, will evaluate Spring Bank's STING antagonist compounds in autoimmune disease models.
   
• Entered into convertible debt financing agreement. In September, Spring Bank entered into a $20 million convertible debt financing agreement with an affiliate of Pontifax Ltd., a healthcare-dedicated venture capital firm with over $775 million under management. The additional new capital extends the company's operating cash runway into 2022 and will support efforts to drive shareholder value without selling equity at the current depressed level, which allows Spring Bank to accelerate its pipeline and generate robust clinical data for differentiated products in disease states where unmet needs remain high.

2019 Third Quarter Financial Results

• Cash Position: Cash, cash equivalents and marketable securities were $63.1 million as of September 30, 2019, compared to cash, cash equivalents and marketable securities of $64.4 million as of December 31, 2018. Net cash used in operating activities for the nine months ended September 30, 2019 was $20.5 million, compared to $18.4 million for the same period in 2018. Spring Bank expects that its existing cash, cash equivalents and marketable securities as of September 30, 2019 are sufficient to fund its operating expenses and capital expenditure requirements into 2022.
  
  
• Operating Expenses: Total operating expenses for the three months ended September 30, 2019 were $7.5 million, which consisted of $5.2 million of research and development (R&D) expenses and $2.2 million of general and administrative (G&A) expenses, compared to total operating expenses of $7.7 million, which consisted of $5.7 million of research and development (R&D) expenses and $2.1 million of general and administrative (G&A) expenses for the three months ended September 30, 2018.
  
  
• Net loss: The company's net loss for the three months ended September 30, 2019 was $(6.9) million, or $(0.42) per basic and diluted share, compared to net loss for the three months ended September 30, 2018 of $(8.8) million, or $(0.59) per basic and diluted share.

Conference Call
Spring Bank will host a conference call and webcast at 4:30pm ET on Monday, November 11, 2019, to discuss the current HBV landscape and the company's development programs. The conference call may be accessed by dialing (877) 407-0789 for U.S. callers and (201) 689-8562 for international callers and providing the conference ID 13696574. 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 call may be accessed by visiting Spring Bank's website.

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's lead product candidate, inarigivir, is being developed for the treatment of chronic HBV. Inarigivir is designed to activate within infected cells retinoic acid-inducible gene 1 (RIG-I), which has been shown to inhibit HBV viral replication and induce the intracellular interferon signaling pathways for antiviral defense. The company is also developing its lead STING agonist product candidate, SB 11285, an immunotherapeutic agent for the treatment of selected cancers.

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 into 2022; the creation of additional long-term value for the company's shareholders; the timing for initiating and reporting results from multiple inarigivir clinical trials and our SB 11285 clinical trial.

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; 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, 2018, which was filed with the Securities and Exchange Commission (SEC) on March 11, 2019, Spring Bank's Quarterly Reports on Form 10-Q that have been filed with the SEC, 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:
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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