Spring Bank Pharmaceuticals Provides Corporate Update and Reports Second Quarter 2017 Financial and Operational Results
July 31 2017 - 4:15PM
Reports multiple recent developments and
milestones
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 second quarter 2017 financial results and
provided an update on recent corporate and clinical developments.
“We are pleased with the progress we accomplished
in the second quarter of this year with several strategic
initiatives at Spring Bank,” commented Martin Driscoll, President
and Chief Executive Officer of Spring Bank Pharmaceuticals, Inc.
“We disclosed positive top-line results from the first cohort of
chronic HBV patients in the ongoing Phase 2a ACHIEVE trial
investigating our lead development compound, SB 9200, and we have
since completed patient enrollment in the second cohort of this
trial. Additionally, we continued to advance our lead preclinical
candidate, SB 11285, from our next-generation STING
(STimulator of INTerferon
Genes) agonist platform with a goal to enter
clinical trials in certain cancers in the second half of 2018.
Importantly, we executed on a financing in June that raised
approximately $40 million in new capital allowing us to accelerate
several programs and strengthening our balance sheet to the point
that our company is now funded through the end of 2019. This
successful financing also enhanced our shareholder base with
high-quality, sophisticated institutional life sciences
investors.”
Mr. Driscoll continued, “We have had a strong start
to the third quarter with the recent announcement of our new
clinical trial collaboration and supply agreement with Gilead for a
Phase 2 trial to examine the co-administration of SB 9200 and
Gilead’s Vemlidy® (tenofovir alafenamide) in chronic HBV patients.
We look forward to making continued progress with multiple
initiatives at our company in the second half of this year.”
Second Quarter 2017 and Recent
Developments
- Completed public offering to strengthen balance
sheet. In June 2017, Spring Bank raised
approximately $40 million of net proceeds through an underwritten
public offering of 3,269,219 shares of our common stock at $13.00
per share. This included 384,604 shares pursuant to the exercise of
an option granted to the underwriters to purchase additional
shares. The net proceeds to the company represent the amount raised
after deducting underwriting discounts and commissions and other
offering expenses payable by the company.
- Reported top-line results in the initial cohort of its
ACHIEVE global Phase 2 clinical trial. In May 2017,
Spring Bank reported top-line results from the first SB 9200
monotherapy dosing cohort of the Phase 2a clinical trial. The Phase
2a segment is a placebo-controlled, sequential-cohort, double-blind
trial designed to evaluate increasing doses of SB 9200 (25mg, 50mg,
100mg and 200mg) as monotherapy for 12 weeks followed by tenofovir
disoproxil fumarate 300 mg (marketed by Gilead Sciences, Inc. as
Viread®) for an additional 12 weeks. The top-line results indicated
that a low dose (25mg) of SB 9200 alone showed a favorable safety
profile and antiviral activity against HBV DNA and HBsAg.
Administration of SB 9200 resulted in a statistically
significant reduction in HBV DNA at week 12 (unpaired t-test 2.85,
p=0.01) compared to placebo, with a mean reduction of 0.6
log10 (range 0 to 1.87 log10) in the SB 9200 treatment group.
The overall safety profile of SB 9200 was favorable with no serious
adverse events observed during the 12-week study.
Treatment-emergent adverse events ranged from mild to moderate in
severity with no interferon-like side effects and were comparable
to patients on placebo.
- Completed patient enrollment in second cohort of its
ACHIEVE global Phase 2 clinical trial. In July 2017,
Spring Bank completed patient screening and enrollment of all
twenty patients in the second cohort of the Phase 2a segment of the
ACHIEVE global Phase 2 clinical trial of SB 9200 in chronic HBV
patients. The company remains on track to report top-line results
from the second dosing cohort in the fourth quarter of 2017.
- 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, SB 9200, 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 SB
9200.
- Published abstract on SB 11285, the company’s lead
STING agonist candidate, at the 2017 American Society of Clinical
Oncology (ASCO) Annual Meeting. In June 2017, an abstract
was published at the ASCO Annual Meeting indicating that SB 11285
showed potent and highly-durable anti-tumor activity in the A20 and
CT26 syngeneic mouse tumor models. The induction of immune-memory
and abscopal anti-tumor activity upon intra-tumoral administration
of SB 11285 was also observed in the A20 lymphoma model. In
addition, Spring Bank reported that SB 11285 exhibited
dose-dependent, potent tumor growth inhibition and durable
anti-tumor response upon intra-tumoral, intraperitoneal and
intravenous routes of administration in the CT26 colon cancer
syngeneic mouse model.
Second Quarter 2017 Financial
Results
- Cash Position: Cash, cash equivalents and
marketable securities were $56.4 million as of June 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 six months ended June 30, 2017 was
$8.8 million, compared to $8.9 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 SB 9200 beyond the company’s Phase 2
ACHIEVE clinical trial.
- Operating Expenses: Total operating expenses
for the three months ended June 30, 2017 were $5.3 million,
which consisted of $3.4 million of research and development
(R&D) expenses and $1.9 million of general and administrative
(G&A) expenses. Total operating expenses for the three months
ended June 30, 2016 were $4.4 million, which consisted of $2.9
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 June 30, 2017 was $8.9 million, or $0.93
per share, compared to $4.3 million for the three months
ended June 30, 2016, or $0.62 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, 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
STimulator of Interferon
Genes, or STING, pathway. For more information,
please visit www.springbankpharm.com.
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 (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 SB 9200 monotherapy dosing cohort
in the Phase 2a trial of SB 9200, and (iii) the anticipated
timeline for 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 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, 2016, which was filed with the
Securities and Exchange Commission (SEC) on February 14, 2017,
Spring Bank's Quarterly Report on Form 10-Q for the quarter ended
June 30, 2017, which was filed with the SEC on July 31, 2017, 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. and
Subsidiaries |
|
Condensed Consolidated Balance Sheets |
(in thousands) |
|
|
|
June 30, |
|
December 31, |
|
|
|
2017 |
|
2016 |
|
|
|
(unaudited) |
|
|
|
Cash and
cash equivalents |
|
$ |
51,443 |
|
$ |
10,684 |
|
Short
and long-term marketable securities |
|
|
4,936 |
|
|
14,798 |
|
Other
assets |
|
|
1,469 |
|
|
1,397 |
|
Total
assets |
|
$ |
57,848 |
|
$ |
26,879 |
|
|
|
|
|
|
|
Warrant
liabilities |
|
$ |
12,027 |
|
$ |
6,333 |
|
Other
liabilities |
|
|
3,577 |
|
|
3,528 |
|
Total
liabilities |
|
|
15,604 |
|
|
9,861 |
|
Total
stockholders’ equity |
|
|
42,244 |
|
|
17,018 |
|
Total
liabilities and stockholders' equity |
|
$ |
57,848 |
|
$ |
26,879 |
|
|
|
|
|
|
|
Consolidated Statements of Operations and
Comprehensive Loss |
(in thousands, except share and per share data) |
(unaudited) |
|
|
|
For the Three Months Ended
June 30, |
|
For the Six Months Ended
June 30, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
Grant
revenue |
|
$ |
— |
|
|
$ |
72 |
|
|
$ |
— |
|
|
$ |
352 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
3,404 |
|
|
|
2,936 |
|
|
|
5,931 |
|
|
|
8,525 |
|
|
General
and administrative |
|
|
1,856 |
|
|
|
1,458 |
|
|
|
3,843 |
|
|
|
2,684 |
|
|
Total
operating expenses |
|
|
5,260 |
|
|
|
4,394 |
|
|
|
9,774 |
|
|
|
11,209 |
|
|
Loss
from operations |
|
|
(5,260 |
) |
|
|
(4,322 |
) |
|
|
(9,774 |
) |
|
|
(10,857 |
) |
|
Interest
income |
|
|
38 |
|
|
|
21 |
|
|
|
79 |
|
|
|
38 |
|
|
Change in
fair value of warrant liabilities |
|
|
(3,667 |
) |
|
|
— |
|
|
|
(5,694 |
) |
|
|
— |
|
|
Net
loss |
|
|
(8,889 |
) |
|
|
(4,301 |
) |
|
|
(15,389 |
) |
|
|
(10,819 |
) |
|
Unrealized gain (loss) on marketable securities |
|
|
— |
|
|
|
4 |
|
|
|
3 |
|
|
|
21 |
|
|
Comprehensive loss |
|
$ |
(8,889 |
) |
|
$ |
(4,297 |
) |
|
$ |
(15,386 |
) |
|
$ |
(10,798 |
) |
|
Net loss
per common share – basic and diluted |
|
$ |
(0.93 |
) |
|
$ |
(0.62 |
) |
|
$ |
(1.63 |
) |
|
$ |
(1.69 |
) |
|
Weighted-average number of common shares used in computing
net loss per share – basic and diluted |
|
|
9,517,086 |
|
|
|
6,923,941 |
|
|
|
9,466,951 |
|
|
|
6,400,538 |
|
|
|
|
|
|
|
|
|
|
|
|
Contact:
Spring Bank Pharmaceuticals, Inc.
Jonathan Freve
Chief Financial Officer
(508) 473-5993
jfreve@springbankpharm.com
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