Quarter highlighted by data presentations at two conferences and the initiation of research collaborations
Confirms top-line results from the second inarigivir (formerly SB 9200) monotherapy dosing cohort of the ACHIEVE trial will be released in Q4 2017
HOPKINTON, Mass., Oct. 31, 2017 (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 third quarter 2017 financial results and provided an update on recent corporate and clinical developments.
“Led by the progress in our Phase 2 ACHIEVE trial in chronic Hepatitis B (HBV) patients, the Spring Bank team continues to execute on our strategic initiatives,” commented Martin Driscoll, president and chief executive officer of Spring Bank Pharmaceuticals. “Data from our ACHIEVE trial demonstrates the potent antiviral effect of inarigivir, a selective oral immunomodulator, and its potential to be part of a simple and safe combinatorial treatment modality that elevates the functional cure rates for patients with chronic HBV. Preclinical data from our STING (STimulator of INterferon Genes) agonist program has demonstrated its antitumor activity in several tumor models, and we look forward to advancing this program with an objective to enter clinical trials in certain cancers in the middle of 2018. We are pleased with the advancement of both of these key Spring Bank development programs and are on track with our milestones.”
Mr. Driscoll added, “Our momentum continues to build into the fourth quarter after having strengthened our balance sheet earlier this year. We look forward to continued progress with inarigivir and our STING agonist platform to close out the year.”
Third Quarter 2017 and Recent Developments
- Commenced patient screening in the third cohort of the Phase 2 ACHIEVE trial. In October 2017, following approval from the Data Safety Monitoring Board, Spring Bank proceeded to the third inarigivir 100mg cohort of Part A of the ACHIEVE trial and commenced patient screening and enrollment of patients. The Company remains on track to report top-line results from the second inarigivir 50mg monotherapy dosing cohort in the fourth quarter of 2017.
- Reported additional results from the initial 25mg cohort of Part A of the ACHIEVE global Phase 2 clinical trial at the American Association for the Study of Liver Disease (AASLD) conference (The Liver Meeting®). In May 2017, Spring Bank reported top-line results from the initial inarigivir 25mg monotherapy segment of the ACHIEVE trial. In October 2017, the Company reported additional data, including the effects of 12 weeks of 25mg inarigivir monotherapy on key virological parameters such as HBsAg, HBV RNA, HBcrAg and associated serological evidence of immune recovery. Key findings included significant declines induced by inarigivir in HBV DNA, HBsAg, HBV RNA and HBcrAg, which together indicate a potent antiviral effect at this low dose of inarigivir, which was highly prevalent in HBeAg-negative patients. Additionally, Spring Bank reported data from the subsequent 12 weeks of Viread® monotherapy following 12 weeks of inarigivir monotherapy, which indicated that switching patients to 300mg daily of Viread® for 12 weeks following the 12 weeks of inarigivir 25mg monotherapy was associated with further declines in HBsAg, as 6 of 16 patients (38%) in the inarigivir treatment group had a greater than 0.5 log10 reduction at week 24, which included 3 HBeAg-positive subjects. An associated greater than 0.75 log10 reduction in HBeAg was seen in 4 of 9 (44%) HBeAg-positive patients that was not seen in the placebo treatment group.
- Announced positive preclinical in vivo data from several tumor models at the American Association for Cancer Research on Tumor Immunology and Immunotherapy. In October 2017, Spring Bank presented data from multiple tumor models in preclinical studies that demonstrated the Company’s next-generation, proprietary STING agonist compound, SB 11285, has highly potent anti-tumor activity along with a durable anti-tumor response when administered by multiple routes in several tumor models. The anti-tumor activity observed in these models correlated with anti-tumoral immune responses. The Company plans to submit an investigational new drug application, or IND, and/or a clinical trial application, or CTA, for SB 11285 in mid-2018, and, if cleared, commence Phase Ib/II clinical trials in liver cancer in the second half of 2018.
- Strengthened Board of Directors Membership. In October 2017, Spring Bank added Christiana Bardon, M.D., as an independent member of its Board of Directors. “We are very pleased to have Dr. Bardon join our Board. Her experience as one of the leading investors in the life sciences industry, together with her impressive background in immunology and oncology, make her a tremendous asset for Spring Bank. We look forward to the strategic insights and broad contributions she will provide to Spring Bank,” said Mr. Driscoll. Dr. Bardon is the portfolio manager of Burrage Capital, as well as a managing director for the Oncology Impact Fund managed by MPM Capital. Dr. Bardon is a founder and managing member of Burrage Capital, a long short hedge fund focused on biotechnology and healthcare. Previously, she was a healthcare analyst at Fidelity Investments covering biotechnology, life science tools and diagnostics. Dr. Bardon earned an M.S./B.S. from the Massachusetts Institute of Technology; an M.D. magna cum laude from Harvard Medical School; and an MBA from Harvard Business School. While at Harvard Medical School, Dr. Bardon was the recipient of a Howard Hughes fellowship. She also completed a residency in internal medicine at the Brigham and Women’s Hospital at Harvard Medical School. She currently serves on the Board of Fellows at Harvard Medical School.
- Initiated a preclinical STING agonist research collaboration. In August 2017, the Company entered into a preclinical research collaboration with a third party to examine the potential for the conjugation of selected compounds from the Spring Bank STING agonist platform with selected proprietary antibodies from the third party’s portfolio.
- Consummated a second HBV clinical collaboration with Gilead. In July 2017, the Company announced that it had entered into a clinical collaboration with Gilead to conduct a Phase 2 trial examining the use of Spring Bank’s oral selective immunomodulator, inarigivir, co-administered with tenofovir alafenamide, marketed by Gilead as Vemlidy®, in patients infected with chronic HBV. Under terms of the agreement, Gilead will conduct and provide funding for the trial and Spring Bank will supply inarigivir. The Company anticipates that Gilead will initiate this clinical trial in the first quarter of 2018.
Third Quarter 2017 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were $52.2 million as of September 30, 2017, compared to cash, cash equivalents and marketable securities of $25.5 million as of December 31, 2016. Net cash used in operating activities for the nine months ended September 30, 2017 was $12.5 million, compared to $11.7 million for the same period in 2016. Spring Bank anticipates that its existing cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements through the end of 2019. However, the Company anticipates that its existing cash, cash equivalents and marketable securities will not be sufficient to fund additional development of inarigivir beyond the Company’s Phase 2 ACHIEVE clinical trial.
- Operating Expenses: Total operating expenses for the three months ended September 30, 2017 were $5.2 million, which consisted of $3.2 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 September 30, 2016 were $4.2 million, which consisted of $2.7 million of R&D expenses and $1.5 million of G&A expenses.
- Net loss: The Company’s net loss for the three months ended September 30, 2017 was $10.8 million, or $0.85 per share, compared to $4.1 million for the three months ended September 30, 2016, or $0.53 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, inarigivir soproxil (formerly SB 9200) 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 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 having sufficient funds to enable it to fund its operating expenses and capital expenditure requirements through the end of 2019, (ii) the Company’s anticipated timeline for disclosing top-line results from the second inarigivir monotherapy dosing cohort in the ACHIEVE trial, (iii) the Company’s expectations for when Gilead will initiate the Phase 2 co-administration trial examining inarigivir and Vemlidy®, and (iv) the anticipated timeline for making regulatory filings and conducting clinical trials for SB 11285.
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials, including the recent results from the initial 25mg cohort of Part A of the ACHIEVE Phase 2 trial; whether Spring Bank’s product candidates will advance through the clinical trial process on a timely basis, or at all; whether Spring Bank’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; 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, Spring Bank's Quarterly Reports on Form 10-Q that have been filed 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.
For investor inquires:
Spring Bank Pharmaceuticals, Inc.
Chief Financial Officer
LifeSci Advisors, LLC
Andrew McDonald, Ph.D.
Josephine Belluardo, Ph.D.
LifeSci Public Relations
|Spring Bank Pharmaceuticals, Inc. and Subsidiaries|
|Condensed Consolidated Balance Sheets|
|September 30,||December 31,|
|Cash and cash equivalents||$||17,539||$||10,684|
|Short and long-term marketable securities||34,640||14,798|
|Total stockholders’ equity||31,924||17,018|
|Total liabilities and stockholders' equity||$||53,848||$||26,879|
|Consolidated Statements of Operations and Comprehensive Loss|
(in thousands, except share and per share data)
|For the Three Months Ended |
|For the Nine Months Ended |
|Research and development||3,221||2,723||9,152||11,247|
|General and administrative||1,968||1,452||5,811||4,136|
|Total operating expenses||5,189||4,175||14,963||15,383|
|Loss from operations||(5,189||)||(4,175||)||(14,963||)||(15,031||)|
|Change in fair value of warrant liabilities||(5,780||)||—||(11,474||)||—|
|Unrealized gain (loss) on marketable securities||(10||)||(3||)||(7||)||18|
|Net loss per common share – basic and diluted||$||(0.85||)||$||(0.53||)||$||(2.48||)||$||(2.18||)|
|Weighted-average number of common shares used in |
computing net loss per share – basic and diluted
Source:Spring Bank Pharmaceuticals, Inc.