2017 highlighted by continued progress with global inarigivir clinical program for the treatment of chronic HBV and advancement of next-generation STING agonist candidate, SB 11285, towards the clinic
Multiple potential development catalysts and data read-outs expected in 2018
HOPKINTON, Mass., Feb. 20, 2018 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. (Nasdaq:SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, today announced its fourth quarter and full-year 2017 financial results and provided an update on recent developments.
“In 2017, we significantly advanced the development of both our RIG-I and STING platforms, entered into strategic partnerships and strengthened our balance sheet,” commented Martin Driscoll, president and chief executive officer of Spring Bank Pharmaceuticals. “With the positive initial top-line results announced from the ongoing Phase 2 ACHIEVE trial for our lead development candidate, inarigivir, we now have the most advanced clinical candidate for chronic hepatitis B and are excited to continue to lead the way in the development of a potential simple, safe and selective functional cure for this disease. We are also encouraged by the preclinical results for our next-generation STING agonist candidate, SB 11285, which lead us to believe that SB 11285 has the potential to be clinically administered intratumorally and intravenously for a variety of tumors at various anatomic sites. Our execution during 2017 has set the stage for what we believe could be a productive 2018 with numerous potential development catalysts.”
Mr. Driscoll continued, “We have multiple objectives that we are working towards in 2018. Our primary objective is to further advance our inarigivir global clinical development program, particularly our clinical trial collaboration with Gilead Sciences involving the co-administration of inarigivir with Gilead Sciences ’s oral antiviral agents, tenofovir disoproxil fumarate (marketed by Gilead Sciences as Viread®) and tenofovir alafenamide (marketed by Gilead Sciences as Vemlidy®). We will continue to execute our broad inarigivir clinical development program by (1) completing the Part A monotherapy dose-finding segment of the ACHIEVE trial, (2) conducting additional formulation development work for SB 9225, our potential fixed-dose co-formulation product combining inarigivir with tenofovir disoproxil fumarate, and (3) pursuing additional combinatorial or “triplet” therapies combining inarigivir, an oral antiviral agent and/or a potential third product or product candidate with a differing mechanism of action. Depending on the results of the ACHIEVE study and additional co-administration clinical trials that we are conducting, it is our objective to enter into a global Phase 3 program with inarigivir in 2019. Finally, we plan to initiate a Phase 1b/2 clinical trial with our novel, next-generation STING agonist, SB 11285, in hepatocellular carcinoma late in the second half of 2018.”
Potential 2018 Milestones
2017 and Other Recent Accomplishments
Year-End and Fourth Quarter 2017 Financial Results
Spring Bank will host a conference call and webcast at 8:30 a.m. EST tomorrow, Wednesday, February 21, 2018, to discuss its 2017 results and objectives for 2018. The conference call may be accessed by dialing (800) 289-0517 for U.S. callers and (323) 794-2423 for international callers and providing the conference ID 5789868. 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 conference call will be available until March 7, 2018 by dialing 844-512-2921 for U.S. callers and 412-317-6671 for international callers and providing the conference ID 5789868.
About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleic acid hybrid (SMNH) chemistry platform. SMNH compounds are small segments of nucleic acids that the company designs to selectively target and modulate the activity of specific proteins implicated in various disease states. The company is developing its most advanced SMNH product candidate, inarigivir soproxil for the treatment of viral diseases, including hepatitis B virus (HBV) and other SMNH product candidates, including SB 11285, the company's lead immunotherapeutic agent for the treatment of selected cancers through the activation of the STimulator of Interferon Genes, or STING, pathway. For more information, please visit www.springbankpharm.com.
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 (i) the company’s general objectives and anticipated timing for achieving those objectives, including, but not limited to, (a) the company’s anticipated timeline for disclosing additional results from the Phase 2 ACHIEVE trial and the Phase 2 trial combining inarigivir and Vemlidy that is being conducted by Gilead Sciences , (b) the company’s objective to initiate a Phase 3 trial for inarigivir in 2019, and (c) the anticipated timeline for submitting a CTA and conducting clinical trials for SB 11285; (ii) the company having sufficient funds to enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2019.
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 cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether Spring Bank’s product candidates will advance through the clinical trial process on a timely basis, or at all; 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, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 20, 2018, 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 subsequent to the date hereof.
For investor inquires:
Spring Bank Pharmaceuticals, Inc.
Chief Financial Officer
LifeSci Advisors, LLC
Andrew McDonald, Ph.D.
LifeSci Public Relations
|Spring Bank Pharmaceuticals, Inc. and Subsidiaries|
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||23,649||$||10,684|
|Short and long-term marketable securities||26,906||14,798|
|Total stockholders’ equity||34,748||17,018|
|Total liabilities and stockholders' equity||$||52,341||$||26,879|
|Consolidated Statements of Operations and Comprehensive Loss|
(in thousands, except share and per share data)
|Three Months Ended|
|Research and development||3,923||2,770||13,075||14,017|
|General and administrative||2,367||1,603||8,178||5,739|
|Total operating expenses||6,290||4,373||21,253||19,756|
|Loss from operations||(6,290)||(4,373)||(21,253)||(19,404)|
|Change in fair value of warrant liabilities||4,679||1,942||(6,795)||1,942|
|Unrealized gain (loss) on marketable securities||(9)||(7)||(16)||11|
|Net loss per common share – basic and diluted||$||(0.11)||$||(0.28)||$||(2.48)||$||(2.39)|
|Weighted-average number of shares outstanding |
– basic and diluted