HOPKINTON, Mass., Feb. 14, 2020 (GLOBE NEWSWIRE) — Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of certain cancers and inflammatory diseases, today announced its financial results for the fourth quarter and year-ended December 31, 2019 and provided an update on recent corporate and clinical development highlights.
“In January, we made the difficult decision to discontinue our development efforts in the field of chronic hepatitis B virus (HBV). We are moving forward by continuing to advance our internally-developed product candidates in the fields of immuno-oncology and inflammatory diseases,” said Martin Driscoll, president and chief executive officer of Spring Bank Pharmaceuticals. “We are progressing our Phase 1 immuno-oncology trial of SB 11285, our next-generation intravenously-administered STING agonist candidate and, leveraging the differentiated chemistry of our STING agonist portfolio, we are expanding our immuno-oncology portfolio by creating new candidates that consist of selected monoclonal antibodies conjugated with our STING agonists. In our early research efforts, our scientists continue to focus on the development of novel orally-available STING antagonists for inflammatory diseases with high unmet needs, with the goal to advance a lead development candidate into IND-enabling activities later this year.”
Mr. Driscoll continued, “With our cash balance of $54.5 million as of December 31, 2019 and as a result of the elimination of costs related to our HBV development program, we estimate that we have the resources to fund our new operating plan into late 2022.”
2019 Highlights and Potential 2020 Milestones
- Initiated SB 11285 Phase 1a/1b Clinical Trial. In September 2019, the company initiated a Phase 1a/1b trial of SB 11285, Spring Bank’s intravenously (IV)-administered STING agonist development candidate. Phase 1a of this trial is a dose-escalation study with IV SB 11285 monotherapy which allows for combination with a checkpoint inhibitor after the completion of the first two cohorts of the trial. Phase 1b of this trial is designed to explore IV SB 11285 antitumor activity in combination with a checkpoint inhibitor in tumor types expected to be responsive to immunotherapy. The trial is being conducted at multiple sites in the United States. By the end of 2020, Spring Bank plans to generate sufficient data from its Phase 1a/1b IV STING agonist program to enable advancement into a Phase 2 clinical trial.
- Partnered with Yale Cancer Center to Evaluate SB 11285 and Radiation Therapy. In September 2019, Dr. Thomas Hayman, MD, Ph.D., from the Department of Therapeutic Radiology at Yale Cancer Center, presented results from a study evaluating the activation of the STING pathway using SB 11285 in combination with radiation therapy. The results demonstrated that the addition of IV SB 11285 to radiation therapy enhanced effectiveness in killing tumors vs. radiation alone in pre-clinical models. The addition of IV SB 11285 showed a synergistic effect in shrinking tumors when combined with radiation in xenograft models of head and neck tumors in mice.
- Entered into Collaboration with UTSW for STING Antagonist Compounds. In August 2019, Spring Bank entered into an agreement with University of Texas Southwestern (UTSW) to evaluate the company’s novel small molecule STING antagonist compounds. UTSW’s Dr. Nan Yan, as Principal Investigator, will evaluate Spring Bank’s STING antagonist compounds in autoimmune disease models. The company plans to initiate IND-enabling activities for a STING antagonist candidate in 2020.
- Strengthened the Company’s Balance Sheet. In September 2019, Spring Bank entered into a $20 million convertible debt financing agreement with an affiliate of Pontifax Ltd., a healthcare-dedicated venture capital firm. With this financing, and after taking into consideration the company’s new operating plan, the company expects that its cash, cash equivalents and marketable securities as of December 31, 2019 will enable it to fund its operating expenses and capital expenditure requirements into late 2022.
- Strengthened the Board of Directors. In July 2019, the company announced that Pamela Klein, M.D., had been elected to the Spring Bank Board of Directors and appointed to the Science and Technology Committee.
Year-End and Fourth Quarter Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were $54.5 million as of December 31, 2019, compared to cash, cash equivalents and marketable securities of $64.4 million as of December 31, 2018. Net cash used in operating activities for the twelve months ended December 31, 2019 was $29.1 million, compared to $25.2 million for the same period in 2018. Spring Bank expects that its existing cash, cash equivalents and marketable securities as of December 31, 2019 is sufficient to fund its operating expenses and capital expenditure requirements into late 2022.
- Operating Expenses: Total operating expenses for the year ended December 31, 2019 were $33.0 million, which consisted of $23.3 million of research and development (R&D) expenses and $9.8 million of general and administrative (G&A) expenses. Total operating expenses for the year ended December 31, 2018 were $28.5 million, which consisted of $19.8 million of R&D expenses and $8.7 million of G&A expenses. For the fourth quarter ended December 31, 2019, operating expenses were $7.4 million, compared to $6.6 million for the fourth quarter ended December 31, 2018.
- Net loss: The Company’s net loss for the year ended December 31, 2019 was $24.1 million, or $1.46 per basic and diluted share, compared to $22.9 million for the year ended December 31, 2018, or $1.59 per basic share and $1.88 per diluted share. Net loss for the fourth quarter ended December 31, 2019 was $7.4 million, or $0.45 per basic and diluted share, compared to net loss for the fourth quarter ended December 31, 2018 of $5.4 million, or $0.33 per basic share and $0.37 per 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 is developing its STING product portfolio with its lead clinical product candidate, SB 11285, an intravenously-administered immunotherapeutic agent for the treatment of selected cancers, its STING antagonist compounds for the treatment of a broad range of inflammatory diseases and its STING agonist ADC program for potential oncology applications. 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 the company having sufficient funds to enable it to fund its operating expenses and capital expenditure requirements into late 2022, the company’s expectations related to its Phase 1 clinical trial for SB 11285 and the company’s plans to initiate IND-enabling activities for its preclinical programs.
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 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 the company’s 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, 2019, which was filed with the Securities and Exchange Commission (SEC) on February 14, 2020 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 could 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.
Chief Financial Officer
LifeSci Advisors, LLC
Ashley R. Robinson
McNeil, Gray & Rice
Senior Account Supervisor
Source: Spring Bank Pharmaceuticals, Inc.
SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Share and Per Share Data)
|Cash and cash equivalents||$||28,709||$||14,724|
|Prepaid expenses and other current assets||3,522||1,649|
|Total current assets||57,977||49,287|
|Marketable securities, long-term||—||16,804|
|Property and equipment, net||2,234||2,319|
|Operating lease right-of-use assets||2,717||—|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other current liabilities||2,438||2,367|
|Accrued interest payable||403||—|
|Operating lease liabilities, current||355||—|
|Total current liabilities||5,406||4,247|
|Convertible term loan, net of unamortized discount||19,070||—|
|Operating lease liabilities, noncurrent||2,869||—|
|Other long-term liabilities||27||193|
|Commitments and contingencies|
|Preferred stock, $0.0001 par value—authorized, 10,000,000 shares at December 31, 2019 and 2018; no shares issued or outstanding at December 31, 2019 and 2018||—||—|
|Common stock, $0.0001 par value—authorized, 200,000,000 shares at December 31, 2019 and 2018; 16,513,763 and 16,434,614 shares issued and outstanding at December 31, 2019 and 2018, respectively||2||2|
|Additional paid-in capital||161,924||157,931|
|Accumulated other comprehensive loss||(235||)||(5||)|
|Total stockholders’ equity||35,526||55,860|
SPRING BANK PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In Thousands, Except Share and Per Share Data)
|Year Ended December 31,|
|Research and development||$||23,270||$||19,751|
|General and administrative||9,751||8,719|
|Total operating expenses||33,021||28,470|
|Loss from operations||(33,021||)||(28,470||)|
|Other income (expense):|
|Change in fair value of warrant liabilities||8,212||4,617|
|Unrealized gain (loss) on marketable securities||(230||)||18|
|Net loss per common share:|
|Weighted-average number of shares outstanding:|