Conference Call to be Held at 8:00 am Eastern Time
Inarigivir Late-Breaker Abstract Accepted for Oral Presentation at EASL The International Liver Congress 2019
HOPKINTON, Mass., March 11, 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 fourth quarter and year-ended December 31, 2018 and provided an update on recent corporate and clinical development highlights.
“Spring Bank made significant progress in 2018 on multiple fronts, particularly the continued advancement of inarigivir for the treatment of chronic hepatitis B (HBV). We expanded our HBV clinical collaboration with Gilead Sciences, Inc., and we progressed the IND-enabling program for SB 11285 in immuno-oncology,” said Martin Driscoll, president and chief executive officer of Spring Bank Pharmaceuticals. “We have completed our inarigivir Phase 2 dose escalation study named ACHIEVE and are now launching our CATALYST trials, our Phase 2b clinical program, in naïve and virally-suppressed HBV patients. With the launch of the CATALYST inarigivir 400mg monotherapy and co-administration trials and the Phase 2 studies concurrently being conducted by Gilead under our HBV clinical trial collaboration, our inarigivir clinical program will be one of the largest for an HBV compound currently in clinical development.”
Mr. Driscoll further noted, “We are also advancing SB 11285, our novel, second-generation STING (Stimulator of INterferon Genes) agonist compound with the plan to initiate a Phase 1/2 trial in certain cancers in mid-2019. We are currently on track to submit an IND application for SB 11285 in the second quarter of 2019, which if approved, could result in SB 11285 being the first intravenously-administered STING agonist product candidate to enter clinical development. As we first disclosed at our Spring Bank R&D Day in December, we continue to make good progress in the advancement of our three new early research programs utilizing our small molecule nucleic acid chemistry platform, including a novel platform of STING antagonists, chiral antisense compounds against the HBx gene and next-generation RIG-I agonists for potential immuno-oncology uses.”
Mr. Driscoll concluded, “In August 2018, we raised approximately $41 million in gross proceeds from a public offering of our common stock, and now have the resources to fund our current inarigivir Phase 2b HBV program and the Phase 1b development of SB 11285.”
Potential 2019 Milestones
- European Association for the Study of Liver Diseases (EASL), The International Liver Congress, 2019
- A late-breaker inarigivir abstract has been accepted for oral presentation at EASL’s The International Liver Congress 2019 to be held in mid-April in Vienna. This presentation will describe the results from the ACHIEVE trial inarigivir 200mg dosing cohort.
- Also, a poster will be presented by Professor Stephen Locarnini, Head of Research & Molecular Development at the Victorian Infectious Diseases Reference Laboratory and Principal Investigator of the Virology Core for the ACHIEVE trial, describing the compelling activity of inarigivir in HBV clinical isolates consisting of capsid inhibitor and nucleoside analog (“NUC”) resistant variants.
- CATALYST Trials. In the first half of 2019, Spring Bank plans to initiate two Phase 2 global trials (CATALYST 1 and CATALYST 2) examining the administration of inarigivir 400mg as monotherapy and co-administered with a NUC in naïve and virally-suppressed chronic HBV patients. The CATALYST trials will include multiple patient cohorts with dosing periods to include 12 weeks, 24 weeks, and 48 weeks. The first clinical trial application (CTA) has been filed for a CATALYST trial and regulatory applications in multiple countries, including the U.S., will be filed throughout the first, second and third quarters of 2019. The CATALYST trial designs allow for evaluation of the likelihood of functional cure and have the potential to define the design of Phase 3 trials to allow for a regulatory strategy for the co-administration of inarigivir with a NUC and inarigivir monotherapy in selected chronic HBV patient populations. The company anticipates reporting interim top-line results from the CATALYST trials throughout 2020 and continuing into 2021.
- SB 9225 (inarigivir + tenofovir disoproxil fumarate). Spring Bank has successfully manufactured initial quantities of the fixed-dose combination of inarigivir and tenofovir disoproxil fumarate named SB 9225. Based on the results of the company’s CATALYST Phase 2b inarigivir trials and the ongoing Gilead co-administration studies, Spring Bank could be in a position to initiate a Phase 3 program for SB 9225 in 2020.
- Liver Biopsy Study. Spring Bank plans to conduct a single center study to evaluate the intra-hepatic activation of the immune response by inarigivir and to correlate immunology findings with the effect on HBV intra-hepatic virology, in particular cccDNA. The company anticipates reporting initial results from this study in late 2019.
- Additional Clinical Trial Collaborations with Inarigivir. Spring Bank continues to explore novel combination opportunities for inarigivir, including combination with siRNA compounds and core protein allosteric modifiers (CpAMs). Spring Bank anticipates that inarigivir, together with a NUC, will be included in at least one “triple combination” clinical trial with one of these mechanisms in 2019.
- SB 11285 (STING agonist candidate). The company plans to submit an investigational new drug application (IND) for SB 11285 in the second quarter of 2019 and, if approved, will initiate a Phase 1/2 clinical trial in certain cancers in mid-2019. SB 11285 could be the first intravenously-administered STING agonist product candidate to enter clinical development.
2018 Highlights and Recent Business Developments
- Completed Phase 2 ACHIEVE Trial. Approximately 80 treatment-naïve patients infected with chronic HBV have received doses of 25mg, 50 mg, 100mg or 200mg of inarigivir or a placebo as a monotherapy administered daily for 12 weeks, followed by all patients receiving a sequential dose of Viread® for 12 weeks.
- In August 2018, the company announced positive study results from the third cohort (inarigivir 100mg) of the ACHIEVE trial, including reporting that 28% of inarigivir treated patients across the first three cohorts of the ACHIEVE trial had demonstrated a hepatitis B surface antigen (HBsAg) response with a mean reduction of 0.8log10 and a maximum reduction of 1.4log10 in the responder population.
- In February 2019, all patients in the final 200mg cohort of the ACHIEVE trial completed the 12-week sequential dosing of Viread.
- Expanded Gilead Clinical Trial Collaboration. In August 2018, the company announced the expansion of its Phase 2 clinical trial collaboration with Gilead to include two additional cohorts examining (i) the co-administration of inarigivir 200mg and Vemlidy® in naïve chronic HBV patients and (ii) the administration of inarigivir 100mg in virally-suppressed patients who currently are and continue to be treated with a NUC.
- Strengthened the Board of Directors and Management Team. In February 2018 and August 2018, the company strengthened its board with the addition of industry veterans Timothy Clackson, Ph.D., and Scott Smith. Mr. Smith was appointed as Chairman of the Board in December 2018. In addition, in February 2019, the company hired Atif Abbas, M.D., as Vice President, Head of Oncology & Immunology Clinical Development.
- Strengthened the Company’s Balance Sheet. In August 2018, the company conducted a public offering of common stock raising gross proceeds of approximately $41 million.
- Advancement of Early Research Programs. In connection with the company’s Research and Development Day in December 2018, the company announced that it is exploring three new early research programs utilizing its small molecule nucleic acid chemistry platform combined with the company’s proprietary chiral technology expertise. These programs include a novel platform of STING antagonists, chiral antisense compounds against the HBx gene and next-generation RIG-I agonists for potential immune-oncology uses.
Year-End and Fourth Quarter Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were $64.4 million as of December 31, 2018, compared to cash, cash equivalents and marketable securities of $50.6 million as of December 31, 2017. Net cash used in operating activities for the twelve months ended December 31, 2018 was $25.2 million, compared to $17.7 million for the same period in 2017. Spring Bank expects that its existing cash, cash equivalents and marketable securities as of December 31, 2018 is sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2021.
- Operating Expenses: Total operating expenses for the year ended December 31, 2018 were $28.5 million, which consisted of $19.8 million of research and development (R&D) expenses and $8.7 million of general and administrative (G&A) expenses. Total operating expenses for the year ended December 31, 2017 were $21.3 million, which consisted of $13.1 million of R&D expenses and $8.2 million of G&A expenses. For the fourth quarter ended December 31, 2018, operating expenses were $6.6 million, compared to $6.3 million for the fourth quarter ended December 31, 2017.
- Net loss: The Company’s net loss for the year ended December 31, 2018 was $(22.9) million, or $(1.59) per basic share ($(1.88) per diluted share), compared to $(27.7) million for the year ended December 31, 2017, or $(2.48) per basic and diluted share. Net loss for the fourth quarter ended December 31, 2018 was $(5.4) million, or $(0.33) per basic share ($(0.37) per diluted share), compared to net loss for the fourth quarter ended December 31, 2017 of $(1.5) million, or $(0.11) per basic and diluted share.
Spring Bank will host a conference call and webcast at 8:00 am EDT today, Monday, March 11, 2019, to discuss its results and objectives for 2019. 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 13687792. 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 hepatitis B virus (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, including funding of the inarigivir Phase 2b HBV program and the Phase 1b development of SB 11285; the company’s general plans and timing for clinical development of inarigivir and SB 11285; the company’s planned clinical trial designs for CATALYST 1 and CATALYST 2; the timing for reporting results from multiple inarigivir clinical trials; the company’s anticipated plans for conducting additional inarigivir clinical trial collaborations; and the anticipated timeline to begin a phase 3 trial for SB 9225.
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
Source: Spring Bank Pharmaceuticals, Inc.
SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Share and Per Share Data)
|Cash and cash equivalents||$||14,724||$||23,649|
|Prepaid expenses and other current assets||1,649||580|
|Total current assets||49,287||51,135|
|Marketable securities, long-term||16,804||—|
|Property and equipment, net||2,319||687|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other current liabilities||2,367||2,734|
|Total current liabilities||4,247||4,434|
|Other long-term liabilities||193||31|
|Commitments and contingencies (Note 9)|
|Preferred stock, $0.0001 par value—authorized, 10,000,000 shares at December 31, 2018 and 2017; noshares issued or outstanding at December 31, 2018 and 2017||—||—|
|Common stock, $0.0001 par value—authorized, 200,000,000 shares at December 31, 2018 and 2017; 16,434,614 and 12,961,993 shares issued and outstanding outstanding at December 31, 2018 and 2017, respectively||2||1|
|Additional paid-in capital||157,931||113,984|
|Other comprehensive loss||(5||)||(23||)|
|Total stockholders’ equity||55,860||34,748|
SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In Thousands, Except Share and Per Share Data)
|Year Ended December 31,|
|Research and development||$||19,751||$||13,075|
|General and administrative||8,719||8,178|
|Total operating expenses||28,470||21,253|
|Loss from operations||(28,470||)||(21,253||)|
|Other income (expense):|
|Change in fair value of warrant liabilities||4,617||(6,795||)|
|Unrealized gain (loss) on marketable securities||18||(16||)|
|Net loss per common share:|
|Weighted-average number of shares outstanding:|