HOPKINTON, Mass., Aug. 01, 2016 (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 announced second quarter 2016 financial results and provided an update on recent corporate and clinical developments.
“We made good progress in the second quarter, achieving two major milestones for our company with the completion of our initial public offering and the dosing of the first patient in our ACHIEVE Phase 2a clinical trial of our lead compound, SB 9200, in Hepatitis B,” said Martin Driscoll, President and Chief Executive Officer of Spring Bank. “Chronic Hepatitis B remains a major global health challenge in need of a functional cure, and we believe SB 9200 has the potential to significantly improve the lives of patients living with this and other serious and chronic viral diseases. With a strengthened balance sheet from our IPO, we look forward to executing on the ACHIEVE Phase 2a trial and reporting topline data in the first half of next year.”
Second Quarter 2016 Research & Development Highlights
- Dosed first patient in ACHIEVE global Phase 2a clinical trial of SB 9200 in HBV. The Phase 2a portion is a placebo-controlled, sequential-cohort, double-blind trial to evaluate increasing doses of SB 9200 (25mg, 50mg, 100mg and 200mg) as monotherapy for 12 weeks followed by tenofovir disoproxil fumarate (marketed by Gilead Sciences, Inc. as Viread®) 300 mg for an additional 12 weeks.
- Presented preclinical data at the 29th International Conference on Antiviral Research (ICAR). The data demonstrated that SB 9200 showed compelling antiviral activity in the woodchuck model of HBV and in RSV-infected mice consistent with the immunomodulatory mechanism of action of SB 9200.
- Presented preclinical data at the 2016 European Association for the Study of the Liver (EASL) Annual Meeting. SB 9200 followed by entecavir resulted in significant declines in viral DNA, RNA and surface antigens in the woodchuck model of HBV. Additionally, SB 9200 inhibited the replication of HCV genotypes 1-6, including variants resistant to current direct-acting antivirals in patients who were treatment-naïve, responders or treatment-failures.
- Continued to advance the pre-clinical development of SB 9200 for additional therapeutics uses. These include the fixed-dose combination of SB 9200 with the nucleoside/tide analogues for HBV and the formulation of SB 9200 for the intranasal route of administration in certain viral respiratory diseases.
- Advanced the pre-clinical development of the Company's new small molecule nucleic acid hybrid compounds that activate the STING (STimulator of INterferon Genes) pathway in immuno-oncology and filed patent applications related to these novel, proprietary compounds. Recent published scientific literature indicates that STING can detect the presence of tumor cells and the activation of STING can result in induction of cellular Interferon production and promote an aggressive and strong anti-tumor response.
Second Quarter 2016 and Recent Corporate Developments
- Completed an initial public offering and attained listing on the NASDAQ Capital Market. The Company sold 944,900 shares at an offering price of $12 per SBPH share, resulting in gross proceeds of $11.3 million. Additionally, the Company received $5.3 million from warrants exercised in connection with the IPO.
- Appointed Dr. Todd Brady to the Board of Directors. Dr. Brady currently serves as Chief Executive Officer, President and Director of Aldeyra Therapeutics (Nasdaq:ALDX), a developer of drugs for the treatment of inflammation and inborn errors of metabolism.
- Added to the Russell Microcap Index, effective June 27, 2016. As a result, SBPH shares were automatically included in the appropriate growth and value style index. Inclusion in the index remains in place for one year.
Second Quarter 2016 Financial Results
Net loss for the quarter ended June 30, 2016 was $(4.3) million, or $(0.62) per basic and diluted share, as compared to a net loss of $(2.3) million, or $(0.39) per basic and diluted share, for the same period in 2015.
Research and development expenses for the quarter ended June 30, 2016 were $2.9 million as compared to $1.5 million for the same period in 2015. The increase in R&D expenses was due to increased spending on clinical trial-related activities for the Company’s ongoing Phase 2a clinical trial of SB 9200.
General and administrative expenses for the quarter ended June 30, 2016 were $1.5 million as compared to $1.1 million for the same period in 2015. The increase in general and administrative expenses was due to additional salaries, benefits and stock-based compensation associated with higher headcount.
The weighted-average number of shares outstanding used to calculate basic and diluted loss per share was 6,923,941 in the second quarter of 2016 compared to 5,796,095 in the second quarter of 2015.
As of June 30, 2016, Spring Bank had $19.6 million of cash, cash equivalents and marketable securities.
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, or SMNH, chemistry platform. The company is developing its most advanced SMNH product candidate, SB 9200, for the treatment of viral diseases, including hepatitis B virus.
Forward-Looking Statements
Any statements in this press release about Spring Bank’s future expectations, plans and prospects, including statements about Spring Bank’s financial prospects, future operations and sufficiency of funds for future operations, clinical development of Spring Bank’s product candidates, expectations regarding future clinical trials and future expectations and plans and prospects for Spring Bank and 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 anticipated; whether results obtained in 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; 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 quarterly report on Form 10-Q for the quarter ended June 30, 2016, which is on file 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 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. | |||||||||||||||||
| Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||||
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | ||||||||||||||||
| 2016 | 2015 | 2016 | 2015 | ||||||||||||||
| Grant revenue | $ | 72 | $ | 331 | $ | 352 | $ | 581 | |||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 2,936 | 1,545 | 8,525 | 2,678 | |||||||||||||
| General and administrative | 1,458 | 1,054 | 2,684 | 2,129 | |||||||||||||
| Total operating expenses | 4,394 | 2,599 | 11,209 | 4,807 | |||||||||||||
| Loss from operations | (4,322 | ) | (2,268 | ) | (10,857 | ) | (4,226 | ) | |||||||||
| Other income (expense): | |||||||||||||||||
| Interest income | 21 | 5 | 38 | 5 | |||||||||||||
| Net loss | (4,301 | ) | (2,263 | ) | (10,819 | ) | (4,221 | ) | |||||||||
| Unrealized gain (loss) on marketable securities | 4 | (5 | ) | 21 | (5 | ) | |||||||||||
| Comprehensive loss | $ | (4,297 | ) | $ | (2,268 | ) | $ | (10,798 | ) | $ | (4,226 | ) | |||||
| Net loss per common share – basic and diluted | $ | (0.62 | ) | $ | (0.39 | ) | $ | (1.69 | ) | $ | (0.76 | ) | |||||
| Weighted-average number of shares outstanding – basic and diluted | 6,923,941 | 5,796,095 | 6,400,538 | 5,567,577 | |||||||||||||
| Spring Bank Pharmaceuticals, Inc. | |||||||||
| Consolidated Balance Sheets | |||||||||
| (in thousands, except share and per share data) | |||||||||
| June 30, | December 31, | ||||||||
| 2016 | 2015 | ||||||||
| ASSETS | (unaudited) | ||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 11,326 | $ | 4,347 | |||||
| Marketable securities | 8,289 | 5,335 | |||||||
| Prepaid expenses and other current assets | 1,039 | 313 | |||||||
| Total current assets | 20,654 | 9,995 | |||||||
| Marketable securities | — | 3,189 | |||||||
| Property and equipment, net | 523 | 427 | |||||||
| Other assets | — | 966 | |||||||
| Total | $ | 21,177 | $ | 14,577 | |||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 2,858 | $ | 2,183 | |||||
| Accrued expenses and other current liabilities | 1,087 | 1,369 | |||||||
| Total liabilities | 3,945 | 3,552 | |||||||
| Commitments (Note 7) | |||||||||
| Stockholders’ equity: | |||||||||
| Convertible preferred stock, $0.0001 par value—authorized, no shares and 5,000,000 shares at June 30, 2016 and December 31, 2015, respectively; no shares and 1,000,000 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | — | — | |||||||
| Preferred stock, $0.0001 par value—authorized, 10,000,000 and no shares at June 30, 2016 and December 31, 2015, respectively; 1,000,000 shares issued and no shares outstanding at June 30, 2016; no shares issued and outstanding at December 31, 2015 | — | — | |||||||
| Common stock, $0.0001 par value—authorized, 200,000,000 and 50,000,000 shares at June 30, 2016 and December 31, 2015, respectively; 7,757,734 and 5,796,091 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 1 | 1 | |||||||
| Additional paid-in capital | 62,216 | 45,211 | |||||||
| Accumulated deficit | (44,988 | ) | (34,169 | ) | |||||
| Other comprehensive income (loss) | 3 | (18 | ) | ||||||
| Total stockholders’ equity | 17,232 | 11,025 | |||||||
| Total | $ | 21,177 | $ | 14,577 | |||||