HOPKINTON, Mass., July 31, 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 second quarter ended June 30, 2019 and provided an update on recent corporate and clinical development advances.
“Our financial results demonstrate that we focus on investing our shareholders’ capital in an efficient and effective manner,” said Jonathan Freve, Chief Financial Officer at Spring Bank. “We have the resources to execute our plans with potential catalysts and multiple clinical data readouts from our inarigivir and SB 11285 programs expected over the next 15 months, starting with the fourth quarter of this year.”
“Our team at Spring Bank delivered a solid performance in the execution of our key programs in the first half of this year,” said Martin Driscoll, Chief Executive Officer at Spring Bank. “We launched three major new clinical trials in hepatitis B virus (HBV) for inarigivir, our clinical collaboration partners at Gilead have just expanded their co-administration trial involving inarigivir, and the IND for our new immuno-oncology clinical program, intravenously-administered SB 11285, has been accepted and will be in the clinic shortly. In view of the substantial progress our company has made with the continued advancement of our internally developed assets, we believe the company’s stock does not reflect these significant developments and is therefore currently undervalued. We intend to drive shareholder value by generating robust clinical data for differentiated products in disease states such as HBV and immuno-oncology, where unmet needs remain high. That is what we focus on every day at Spring Bank.”
Recent Highlights and Business Developments
- Launched and Dosed First Patients in CATALYST Trials Examining Inarigivir 400mg. In April 2019, the company launched two Phase 2 global trials (CATALYST 1 and CATALYST 2) examining the administration of inarigivir 400mg as monotherapy and co-administered with a nucleo(t)side (“NUC”) in naïve and NUC-suppressed chronic HBV patients, and in July 2019, the company announced that it had dosed its first patients in the NUC-suppressed trial (the CATALYST 2 trial). The CATALYST trials include multiple patient cohorts with dosing periods to include 12 weeks, 24 weeks, and 48 weeks. The CATALYST 1 trial design allows for evaluation of the likelihood of functional cure in treatment-naïve patients and will guide study design for a pivotal trial, expected to commence in 2020, for inarigivir plus a NUC in this population. The CATALYST 2 trial will evaluate NUC-suppressed patients in both an add-on strategy (current NUC treatment + inarigivir 400mg) and a “Stop and Shock” strategy (stopping NUC treatment and adding inarigivir 400mg), which will enable Spring Bank to design Phase 3 programs for the large population of patients waiting for HBV cure.
- Announced FDA Acceptance of IND for Intravenous SB 11285. In July 2019, the company announced that its Investigational New Drug (IND) application for a Phase 1 trial of SB 11285, the company’s intravenously (IV)-administered STimulator of INterferon Gene (STING) agonist development candidate, became effective following clearance by the FDA. The Phase 1 trial aims to evaluate safety, tolerability and initial anti-tumor activity of IV SB 11285 in patients with advanced solid tumors. The company intends to enroll patients in this trial expeditiously with a plan to report top-line results in mid-2020.
- Initiated and Completed Dosing of Patient in Liver Biopsy Study. During the second quarter of 2019, the company launched a single-center study to evaluate the intra-hepatic activation of the immune response with inarigivir 400mg and to correlate immunology findings with the effect on HBV intra-hepatic virology, in particular cccDNA. In July 2019, the company announced that it had completed dosing of its first patient in this liver biopsy study. The company anticipates reporting initial results from this study in late 2019.
- Further Expanded Gilead’s Phase 2 Co-Administration 12-Week Study of Inarigivir and Vemlidy® to Include 400mg cohort. The investigation of inarigivir in combination with Vemlidy® (tenofovir alafenamide 25mg) for naïve chronic HBV patients continues in a Phase 2 clinical study funded and conducted by Gilead. The company recently announced that Gilead will also assess inarigivir 400mg co-administered with Vemlidy®, in addition to the inarigivir 50mg and inarigivir 200mg co-administration cohorts in naïve chronic HBV patients and the administration of inarigivir 100mg in chronic HBV patients currently treated with nucleoside/tide analogues in NUC-suppressed chronic HBV patients. The company anticipates that initial results from this study will be presented at a major scientific conference in the fourth quarter of 2019.
- Presented Pre-Clinical Data on STING Antagonist Program. In July 2019, the company presented pre-clinical data from one of the company’s novel STING antagonist compounds, which showed potent inhibition of interferon and pro-inflammatory cytokines in wild type and dysregulated cGAS-STING models. In vivo administration of this compound antagonized STING-agonist-induced interferon and cytokine production in the blood, spleen and liver in mice, illustrating the potential that this compound has for therapeutic applications in interferonopathies, as well as autoimmune and inflammatory diseases.
- Announced Research Agreement with NIAID. In July 2019, the company entered into a research agreement with The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to evaluate Spring Bank’s hepatitis B virus (HBV) antisense oligonucleotide compounds. The company will seek to accelerate this new internal program with a goal to potentially position a lead compound for use in a clinical trial in late 2020. This trial is expected to evaluate a triple combination for HBV consisting of the lead antisense compound co-administered with inarigivir, the company’s lead Phase 2 product candidate, and a nucleo(s)tide analog, for potentially achieving functional cure.
- Further Strengthened Scientific Expertise of Board of Directors. In July 2019, the company announced that Pamela Klein, M.D., had been elected to the Spring Bank Board of Directors and appointed to the Science and Technology Committee.
2019 Second Quarter Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were $49.2 million as of June 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 six months ended June 30, 2019 was $14.8 million, compared to $13.0 million for the same period in 2018. Spring Bank expects that its existing cash, cash equivalents and marketable securities as of June 30, 2019 are sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2021.
- Operating Expenses: Total operating expenses for the three months ended June 30, 2019 were $9.8 million, which consisted of $7.3 million of research and development (R&D) expenses and $2.5 million of general and administrative (G&A) expenses, compared to total operating expenses of $8.0 million, which consisted of $5.6 million of research and development (R&D) expenses and $2.4 million of general and administrative (G&A) expenses for the three months ended June 30, 2018.
- Net loss: The company’s net loss for the three months ended June 30, 2019 was $(4.6) million, or $(0.28) per basic and diluted share, compared to net loss for the three months ended June 30, 2018 of $(3.8) million, or $(0.29) 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’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.
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 the second quarter of 2021; the creation of additional long-term value for the company’s shareholders, including statements regarding whether or not shares of the company’s common stock are undervalued; the timing for initiating and reporting results from multiple inarigivir clinical trials and the timing of regulatory and clinical developments with respect to SB 11285.
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.
Spring Bank Pharmaceuticals, Inc.
Chief Financial Officer
LifeSci Advisors, LLC
Ashley R. Robinson
McNeil, Gray & Rice
Senior Account Supervisor
Source: Spring Bank Pharmaceuticals, Inc
|SPRING BANK PHARMACEUTICALS, INC. AND SUBSIDIARIES |
CONDENSED CONSOLIDATED BALANCE SHEETS
|June 30,||December 31,|
|Cash and cash equivalents||$||10,547||$||14,724|
|Short and long-term marketable securities||38,646||49,718|
|Operating lease right-of-use assets||2,850||—|
|Operating lease liabilities, noncurrent||3,052||—|
|Total stockholders’ equity||47,941||55,860|
|Total liabilities and stockholders' equity||$||57,067||$||68,811|
|CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
(in thousands, except share and per share data)
|For the Three Months Ended |
|For the Six Months Ended |
|Research and development||$||7,275||$||5,555||$||12,842||$||9,532|
|General and administrative||2,490||2,399||5,300||4,622|
|Total operating expenses||9,765||7,954||18,142||14,154|
|Loss from operations||(9,765||)||(7,954||)||(18,142||)||(14,154||)|
|Change in fair value of warrant liabilities||4,885||3,971||7,706||5,173|
|Unrealized gain (loss) on marketable securities||(97||)||(22||)||(213||)||1|
|Net loss per common share - basic and diluted||$||(0.28||)||$||(0.29||)||$||(0.59||)||$||(0.66||)|
|Weighted-average number of shares outstanding - basic and diluted||16,443,379||13,179,072||16,440,192||13,085,820|