HOPKINTON, Mass., Oct. 25, 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 2018 third quarter financial results and provided an update on recent corporate and clinical developments.
“We continued to make good progress this past quarter with the announcement of positive results from the third cohort of our ACHIEVE Phase 2 HBV trial with inarigivir, our orally-available selective immunomodulator. We are encouraged that we continue to observe dose-dependent efficacy for inarigivir at escalating doses that have been generally well-tolerated and safe. Additionally, we were pleased to see Gilead expand our clinical trial collaboration to add additional cohorts to its trial investigating inarigivir in combination with tenofovir alafenamide in treatment-naïve chronic HBV patients,” said Martin Driscoll, president and chief executive officer of Spring Bank Pharmaceuticals. “The ACHIEVE study results are encouraging, and we believe inarigivir has the potential to become a meaningful backbone therapy in the treatment of patients with chronic HBV. With our recent capital raise of approximately $41 million in gross proceeds we are well positioned to execute on our goals and look forward to our next milestones.”
2018 Third Quarter and Recent Highlights
- Announced positive study results from the third cohort (inarigivir 100mg) of Part A of the ongoing Phase 2 ACHIEVE Trial, including reporting that 28% of inarigivir treated patients across the first three cohorts of the ACHIEVE trial have 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.
- Announced the expansion of the Phase 2 clinical trial being undertaken by Gilead Sciences, Inc. to include two additional cohorts examining (i) inarigivir 100mg co-administered with tenofovir alafenamide 25mg and (ii) the administration of inarigivir 100mg in chronic HBV patients currently treated with a nucleoside/tide analogue.
- Strengthened the company’s balance sheet through the public offering of common shares raising gross proceeds of approximately $41 million.
- Appointed Scott Smith, former Celgene president & COO, to the company’s Board of Directors.
- Announced that the company will present additional inarigivir data in a poster of distinction presentation and one oral presentation at the upcoming American Association for the Study of Liver Disease (AASLD) annual meeting being held from November 9-13 in San Francisco, CA.
2018 Third Quarter Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were $71.3 million as of September 30, 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 nine months ended September 30, 2018 and 2017 was $18.4 million and $12.6 million, respectively. Spring Bank anticipates that its existing cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements for at least the next 12 months.
- Operating Expenses: Total operating expenses for the three months ended September 30, 2018 were $7.7 million, which consisted of $5.7 million of research and development (R&D) expenses and $2.0 million of general and administrative (G&A) expenses. Total operating expenses for the nine months ended September 30, 2018 were $21.9 million, which consisted of $15.2 million of research and development (R&D) expenses and $6.7 million of general and administrative (G&A) expenses.
- Net loss: The Company’s net loss for the three months ended September 30, 2018 was $8.8 million, or $0.59 per basic and diluted share, compared to $10.8 million for the three months ended September 30, 2017, or $0.85 per basic and diluted share. The Company’s net loss for the nine months ended September 30, 2018 was $17.4 million, or $1.27 per basic share ($1.39 per diluted share), compared to $26.2 million for the nine months ended September 30, 2017, or $2.48 per basic and diluted share.
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 soproxil, is being developed for the treatment of chronic hepatitis B virus (HBV). Inarigivir is designed to selectively activate within infected cells retinoic acid-inducible gene 1 (RIG-1), 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 (Stimulator of Interferon Genes) agonist product candidate, SB 11285, an immunotherapeutic agent for the treatment of selected cancers.
Forward-Looking Statements
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 and the outcome of the clinical development of any of its product candidates, including inarigivir.
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.
Contacts
Spring Bank Pharmaceuticals, Inc.
Jonathan Freve
Chief Financial Officer
(508) 473-5993
LifeSci Advisors, LLC
Ashley R. Robinson
(617) 535-7742
Ashley@lifesciadvisors.com
Source: Spring Bank Pharmaceuticals, Inc.
| Spring Bank Pharmaceuticals, Inc. and Subsidiaries | ||||||
| Condensed Consolidated Balance Sheets | ||||||
| (in thousands) | ||||||
| September 30, | December 31, | |||||
| 2018 | 2017 | |||||
| (unaudited) | ||||||
| Cash and cash equivalents | $ | 23,637 | $ | 23,649 | ||
| Short and long-term marketable securities | 47,695 | 26,906 | ||||
| Other assets | 3,735 | 1,786 | ||||
| Total assets | $ | 75,067 | $ | 52,341 | ||
| Warrant liabilities | $ | 9,291 | $ | 13,128 | ||
| Other liabilities | 5,244 | 4,465 | ||||
| Total liabilities | 14,535 | 17,593 | ||||
| Total stockholders’ equity | 60,532 | 34,748 | ||||
| Total liabilities and stockholders' equity | $ | 75,067 | $ | 52,341 | ||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,656 | $ | 3,221 | $ | 15,188 | $ | 9,152 | ||||||||
| General and administrative | 2,059 | 1,968 | 6,681 | 5,811 | ||||||||||||
| Total operating expenses | 7,715 | 5,189 | 21,869 | 14,963 | ||||||||||||
| Loss from operations | (7,715 | ) | (5,189 | ) | (21,869 | ) | (14,963 | ) | ||||||||
| Interest income | 271 | 141 | 603 | 220 | ||||||||||||
| Change in fair value of warrant liabilities | (1,336 | ) | (5,780 | ) | 3,837 | (11,474 | ) | |||||||||
| Net loss | (8,780 | ) | (10,828 | ) | (17,429 | ) | (26,217 | ) | ||||||||
| Unrealized loss on marketable securities | (14 | ) | (10 | ) | (13 | ) | (7 | ) | ||||||||
| Comprehensive Loss | $ | (8,794 | ) | $ | (10,838 | ) | $ | (17,442 | ) | $ | (26,224 | ) | ||||
| Net loss per common share: | ||||||||||||||||
| Basic | $ | (0.59 | ) | $ | (0.85 | ) | $ | (1.27 | ) | $ | (2.48 | ) | ||||
| Diluted | $ | (0.59 | ) | $ | (0.85 | ) | $ | (1.39 | ) | $ | (2.48 | ) | ||||
| Weighted-average number of shares outstanding: | ||||||||||||||||
| Basic | 14,841,197 | 12,696,986 | 13,677,375 | 10,555,461 | ||||||||||||
| Diluted | 16,474,974 | 12,725,333 | 15,311,152 | 12,189,238 | ||||||||||||