HOPKINTON, Mass., Oct. 31, 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 third quarter 2016 financial results and provided an update on recent corporate and clinical developments.
“We made steady progress in the third quarter of 2016, as we continued to enroll patients in our ACHIEVE Phase 2 clinical trial involving our lead compound, SB 9200, in chronic Hepatitis B. We remain on track and look forward to reporting initial results from the first dosing cohort in the first half of next year,” said Martin Driscoll, President and Chief Executive Officer of Spring Bank. “In our clinical development program for SB 9200, an orally-available selective immunomodulator, we seek to demonstrate that SB 9200 has the potential to become a backbone therapy in a combination drug regimen in the effort to increase the functional cure rate for chronic HBV patients. To further this clinical development strategy for SB 9200 in chronic HBV, we announced a clinical collaboration with Arrowhead Pharmaceuticals Inc. earlier this month to explore the use of SB 9200 in combination with Arrowhead’s siRNA compound, ARC-520, in the Arrowhead MONARCH Phase 2 trial in chronic HBV patients.”
“In the past few weeks, we also disclosed early scientific evidence from preclinical studies in which SB 11285, our next generation STING (STimulator of INterferon Genes) agonist, causes apoptosis of multiple tumor-derived cell lines. We look forward to developing this Spring Bank proprietary development compound as a potential immunotherapeutic agent in the treatment of various cancers. We believe SB 11285 has the potential not only as a monotherapy treatment but could also prove effective in combination with other cancer therapies.”
Third Quarter 2016 and Recent Highlights
- Continued patient enrollment in the ACHIEVE global Phase 2 clinical trial of SB 9200 in chronic HBV patients. 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. The company is on track to report preliminary results from the first dosing cohort in the first half of 2017 with top line results for all patients treated with monotherapy SB 9200 in the Phase 2a anticipated by year-end 2017.
- Consummated a pre-clinical/clinical collaboration with Arrowhead Pharmaceuticals for the study of SB 9200 combined with siRNA compound, ARC-520, in chronic HBV patients. The companies plan to first conduct preclinical models with both agents together and then study the agents clinically in a cohort to be added to Arrowhead’s ongoing MONARCH Phase 2b study, in which patients will receive a dosing regimen that includes ARC-520, SB 9200, and an oral direct-acting antiviral.
- Identified lead compound (SB 11285) and continued to advance the pre-clinical development of the Company’s immuno-oncology program with the STING pathway. 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. The Company’s goal is to achieve pre-clinical proof-of-principal in relevant oncology models in 2017.
- Two poster presentations related to pre-clinical data for SB 11285, Spring Bank’s novel next generation STING agonist, were presented by Spring Bank scientists at the AACR Special Conference on Tumor Immunology and Immunotherapy. Among the key pre-clinical findings were that SB 11285 is a highly potent STING agonist that causes the induction of Interferons (IFN), NF-KB, Interferon-stimulating genes (ISGs), cytokines, and pattern recognition receptors (PRRs). SB 11285 was also shown to cause apoptosis of multiple tumor-derived cell lines.
Third Quarter 2016 Financial Results
Net loss for the quarter ended September 30, 2016 was $4.1 million, or $0.53 per basic and diluted share, as compared to a net loss of $3.4 million, or $0.59 per basic and diluted share, for the same period in 2015.
Research and development expenses for the quarter ended September 30, 2016 were $2.7 million as compared to $2.1 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 September 30, 2016 were $1.5 million as compared to $1.6 million for the same period in 2015.
The weighted-average number of shares outstanding used to calculate basic and diluted loss per share was 7,759,630 in the third quarter of 2016 compared to 5,796,091 in the third quarter of 2015.
As of September 30, 2016, Spring Bank had $15.6 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 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; 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 September 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 September 30, |
For the Nine Months Ended September 30, |
|||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Grant revenue | $ | – | $ | 260 | $ | 352 | $ | 841 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,723 | 2,101 | 11,247 | 4,779 | ||||||||||||
| General and administrative | 1,452 | 1,566 | 4,136 | 3,695 | ||||||||||||
| Total operating expenses | 4,175 | 3,667 | 15,383 | 8,474 | ||||||||||||
| Loss from operations | (4,175 | ) | (3,407 | ) | (15,031 | ) | (7,633 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense), net | 27 | 10 | 65 | 15 | ||||||||||||
| Net loss | (4,148 | ) | (3,397 | ) | (14,966 | ) | (7,618 | ) | ||||||||
| Unrealized gain (loss) on marketable securities | (3 | ) | 2 | 18 | (3 | ) | ||||||||||
| Comprehensive loss | $ | (4,151 | ) | $ | (3,395 | ) | $ | (14,948 | ) | $ | (7,621 | ) | ||||
| Net loss per common share – basic and diluted | $ | (0.53 | ) | $ | (0.59 | ) | $ | (2.18 | ) | $ | (1.35 | ) | ||||
| Weighted-average number of shares outstanding – basic and Diluted |
7,759,630 | 5,796,091 | 6,856,876 | 5,644,587 | ||||||||||||
| Spring Bank Pharmaceuticals, Inc. | ||||||||||||
| Consolidated Balance Sheets | ||||||||||||
| (in thousands, except per share data) | ||||||||||||
| September 30, | December 31, |
|||||||||||
| 2016 | 2015 |
|||||||||||
| (unaudited) | ||||||||||||
| ASSETS | ||||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 5,332 | $ | 4,347 | ||||||||
| Marketable securities | 10,313 | 5,335 | ||||||||||
| Prepaid expenses and other current assets | 1,059 | 313 | ||||||||||
| Total current assets | 16,704 | 9,995 | ||||||||||
| Marketable securities | — | 3,189 | ||||||||||
| Property and equipment, net | 496 | 427 | ||||||||||
| Other assets | 35 | 966 | ||||||||||
| Total | $ | 17,235 | $ | 14,577 | ||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | $ | 2,340 | $ | 2,183 | ||||||||
| Accrued expenses and other current liabilities | 1,360 | 1,369 | ||||||||||
| Total liabilities | 3,700 | 3,552 | ||||||||||
| Commitments | ||||||||||||
| Stockholders’ equity: | ||||||||||||
| Convertible preferred stock, $0.0001 par value—authorized, no shares and 5,000,000 shares at September 30, 2016 and December 31, 2015, respectively; no shares and 1,000,000 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively |
— | — | ||||||||||
| Preferred stock, $0.0001 par value—authorized, 10,000,000 and no shares at September 30, 2016 and December 31, 2015, respectively; no shares issued or outstanding at September 30, 2016 and December 31, 2015 |
— | — | ||||||||||
| Common stock, $0.0001 par value—authorized, 200,000,000 and 50,000,000 shares at September 30, 2016 and December 31, 2015, respectively; 7,767,981 and 5,796,091 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively |
1 | 1 | ||||||||||
| Additional paid-in capital | 62,669 | 45,211 | ||||||||||
| Accumulated deficit | (49,135 | ) | (34,169 | ) | ||||||||
| Other comprehensive income (loss) | — | (18 | ) | |||||||||
| Total stockholders’ equity | 13,535 | 11,025 | ||||||||||
| Total | $ | 17,235 | $ | 14,577 | ||||||||
CONTACT: Contact: Jon Freve Chief Financial Officer (508) 473-5993 jfreve@springbankpharm.com
