HOPKINTON, Mass., April 28, 2017 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. (Nasdaq:SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, cancer, and inflammatory diseases, today provided an update on recent developments and reported financial results for the first quarter 2017.
“We achieved a significant milestone for Spring Bank earlier this week with the final monotherapy dosing of our lead development compound, SB 9200, in the last patient of the first cohort of our ACHIEVE global Phase 2a trial in chronic Hepatitis B patients,” said Martin Driscoll, president and chief executive officer of Spring Bank. “We continue to execute on our timeline goals for our Phase 2a ACHIEVE trial examining the use of SB 9200 in chronic HBV patients and look forward to the release of the first top-line data from this important study later this quarter.”
Mr. Driscoll continued, “We are also encouraged by the positive response to data we released in the first quarter of this year related to our first in vivo experiments in certain cancer models involving our lead cancer immunotherapy agent, SB 11285, a novel, proprietary next-generation STING (STimulator of INterferon Genes) agonist. We will continue to advance our SB 11285 preclinical program with an objective to potentially file an Investigational New Drug (IND) application in mid-2018.”
Recent Research and Development Progress and Key Objectives
- Completed monotherapy dosing in the first cohort of the ACHIEVE global Phase 2a clinical trial of SB 9200 in chronic HBV patients. The Phase 2a portion of the clinical trial is a placebo-controlled, sequential-cohort, double-blind trial to evaluate increasing doses of SB 9200 (25mg, 50mg, 100mg and 200mg) as a monotherapy for 12 weeks, followed by 300 mg of tenofovir disoproxil fumarate (marketed by Gilead Sciences, Inc. as Viread®) as a monotherapy for an additional 12 weeks. Spring Bank remains on track and anticipates reporting top-line results from the SB 9200 25mg monotherapy dosing cohort in the second quarter of 2017.
- Presented preclinical data for SB 11285, Spring Bank’s novel next generation STING agonist, at the Keystone Symposia on Cancer Immunology and Immunotherapy in March 2017. Among the key preclinical findings were that SB 11285 showed notable anti-tumor activity in the 4T1 breast cancer syngeneic mouse model and the A20 lymphoma model. In the A20 lymphoma model, when SB 11285 was used in combination with cyclophosphamide (Cytoxan®), additive tumor growth inhibitory and tumor growth delay effects were also seen. Spring Bank hopes to achieve further preclinical proof-of-principle for SB 11285 in relevant oncology models in 2017 and, subject to the results of these preclinical studies, file an IND application for SB 11285 in mid-2018.
2017 First Quarter Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were $21.1 million as of March 31, 2017, compared to cash, cash equivalents and marketable securities of $25.5 million as of December 31, 2016. Net cash used in operating activities in the first quarter of 2017 was $4.1 million. Spring Bank anticipates that its existing cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2018.
- Operating Expenses: Total operating expenses for the three months ended March 31, 2017 were $4.5 million, which consisted of $2.5 million of research and development (R&D) expenses and $2.0 million of general and administrative (G&A) expenses. Total operating expenses for the three months ended March 31, 2016 were $6.8 million, which consisted of $5.6 million of R&D expenses and $1.2 million of G&A expenses.
- Net loss: The Company’s net loss for the three months ended March 31, 2017 was $6.5 million, or $0.69 per share, compared to $6.5 million for the three months ended March 31, 2016, or $1.11 per share.
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, SB 9200, for the treatment of viral diseases, including hepatitis B virus (HBV). SB 9200 has been designed to selectively activate within infected cells the cellular proteins, retinoic acid-inducible gene 1, or RIG-I, and nucleotide-binding oligomerization domain-containing protein 2, or NOD2, which have been implicated in the body's immune response to viral infections. Spring Bank believes that SB 9200 may play an important role in antiviral therapy by modulating the body's immune response through its mechanisms of action to fight viral infections such as HBV. For more information, please visit www.springbankpharm.com
Any statements in this press release about Spring Bank’s future expectations, plans and prospects, including, but not limited to, statements about (i) the company having sufficient funds to enable it to fund its operating expenses and capital expenditure requirements at least into the third quarter of 2018, (ii) the company’s anticipated timeline for disclosing top-line results from the first SB 9200 monotherapy dosing cohort in the Phase 2a trial of SB 9200, (iii) the company’s plans for the continued development of SB 11285 and (iv) the anticipated timing for filing an IND application for SB 11285, as well as any other statements containing the words "believes," "anticipates," "estimates," "expects," "intends," "plans," "predicts," "projects," "targets," "may," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.
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, 2016, which was filed with the Securities and Exchange Commission (SEC) on February 14, 2017, 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.
|Spring Bank Pharmaceuticals, Inc. and Subsidiaries|
Condensed Consolidated Balance Sheets
|March 31,||December 31,|
|Cash and cash equivalents||$||14,038||$||10,684|
|Short and long-term marketable securities||7,062||14,798|
|Total stockholders’ equity||10,993||17,018|
|Total liabilities and stockholders' equity||$||22,202||$||26,879|
|Consolidated Statements of Operations and Comprehensive Loss|
(in thousands, except share and per share data)
|Three Months Ended |
|Research and development||2,527||5,589|
|General and administrative||1,987||1,226|
|Total operating expenses||4,514||6,815|
|Loss from operations||(4,514||)||(6,535||)|
|Change in fair value of warrant liabilities||(2,027||)||—|
|Unrealized gain (loss) on marketable securities||3||(1||)|
|Net loss per common share – basic and diluted||$||(0.69||)||$||(1.11||)|
|Weighted-average number of common shares used in |
computing net loss per share – basic and diluted
Contact: Spring Bank Pharmaceuticals, Inc. Jonathan Freve Chief Financial Officer (508) 473-5993 firstname.lastname@example.org
Source:Spring Bank Pharmaceuticals Inc.