Sunesis Pharmaceuticals Reports First Quarter 2019 Financial Results and Recent Highlights
09 May 2019 - 6:05AM
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported
financial results for the first quarter ended March 31, 2019. Loss
from operations for the three months ended March 31, 2019 was $5.7
million. As of March 31, 2019, cash and cash equivalents totaled
$24.8 million.
“We continue our focus on the execution of the
Phase 1b/2 trial of vecabrutinib and are excited to announce that
we have completed the safety evaluation period for the 100 mg
cohort, enabling us to advance the trial into the 200 mg cohort,”
said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis.
“To date, vecabrutinib appears to be well tolerated in the context
of disease, and we will be providing a clinical update on the study
at the European Hematology Association annual meeting in June.”
Mr. Misfeldt continued, “Underscoring our
clinical progress is a strengthened financial position. We began
the first quarter by completing an equity offering with leading
biotechnology investors, extending our cash runway through
important clinical milestones, and just last month we announced the
refinancing of our debt on favorable terms through an agreement
with Silicon Valley Bank, a vote of confidence in our pipeline and
its potential from a premier debt provider for life science
companies.”
Recent Highlights
- Advancement into 200 mg Cohort. The Company
has opened the 200 mg cohort in the Phase 1b/2 trial of its
non-covalent BTK inhibitor vecabrutinib in adults with
relapsed/refractory chronic lymphocytic leukemia (CLL) and other
B-cell malignancies.
- $5.5 Million Loan with Silicon Valley Bank. In
April 2019, the Company entered into a $5.5 million loan agreement
with Silicon Valley Bank. The new agreement allows the company to
retire its existing loan and defer any principal repayment on the
new loan for more than 18 months. The new facility includes
interest-only payments through 2020, with principal repayment over
24 months beginning in 2021, as well as a lower interest rate than
the previous loan. The loan was used for the repayment of the
Company’s existing indebtedness.
- Completion of $20 Million Financing. In
January, Sunesis completed an equity financing with net proceeds of
approximately $18.6 million. The financing attracted participation
from leading biotechnology investors and will allow Sunesis to
advance vecabrutinib through important clinical milestones as the
ongoing dose-escalation study explores potentially active dose
levels.
Financial Highlights
- Cash and cash equivalents totaled $24.8 million as of March 31,
2019, as compared to $13.7 million as of December 31, 2018. The
increase of $11.1 million was primarily due to $18.6 million net
proceeds from issuance of common and preferred stock, offset by
$6.1 million net cash used in operating activities and $1.4 million
principal payment on the Loan Agreement with Western Alliance Bank
and Solar Capital Ltd.
- Research and development expense was $3.2 million for the three
months ended March 31, 2019, as compared to $4.0 million for the
same period in 2018. The decrease of $0.8 million between the
comparable three-month periods was primarily due to a $0.4 million
decrease in salary and personnel expenses due to lower headcount
and a $0.4 million decrease in professional services related to
higher expenses incurred in the first quarter of 2018 for the
start-up cost of Phase 1b/2 trial for vecabrutinib.
- General and administrative expense was $2.4 million for the
three months ended March 31, 2019, as compared to $3.4 million for
the same period in 2018. The decrease of $1.0 million between the
comparable three-month periods was primarily due to a $0.7 million
decrease in salary and personnel expenses due to lower headcount
and a $0.4 million decrease in professional services expenses due
in part to lower vosaroxin patent expenses.
- Interest expense was $0.3 million for the three months ended
March 31, 2019 and 2018. The interest expenses from both periods
resulted from payments on our Loan Agreement with Western Alliance
Bank and Solar Capital Ltd.
- Cash used in operating activities was $6.1 million for the
three months ended March 31, 2019, as compared to $6.6 million
for the same period in 2018. Net cash used in the three months
ended March 31, 2019 resulted primarily from the net loss of $5.9
million, partially offset by adjustments for non-cash items of $0.5
million and changes in operating assets and liabilities of $0.7
million. Net cash used in the three months ended March 31, 2018,
resulted primarily from the net loss of $7.3 million and changes in
operating assets and liabilities of $0.2 million, offset by net
adjustments for non-cash items of $0.9 million.
- Loss from operations was $5.7 million for the three months
ended March 31, 2019, as compared to $7.1 million for the same
period in 2018. Net loss was $5.9 million for the three
months ended March 31, 2019, as compared to $7.3 million for the
same period in 2018.
Conference Call Information
Sunesis will host a conference today at 4:30
p.m. Eastern Time. The call can be accessed by dialing (844)
296-7720 (U.S. and Canada) or (574) 990-1148 (international) and
entering passcode 1396684. To access the live audio webcast, or the
subsequent archived recording, visit the “Investors and Media –
Calendar of Events” section of the Sunesis website
at www.sunesis.com. The webcast will be recorded and available
for replay on the company’s website for two weeks.
About Sunesis
Pharmaceuticals
Sunesis is a biopharmaceutical company
developing new targeted therapeutics for the treatment of
hematologic and solid cancers. Sunesis has built an experienced
drug development organization committed to improving the lives of
people with cancer. The Company is focused on advancing its novel
kinase inhibitor pipeline, with an emphasis on its oral
non-covalent BTK inhibitor vecabrutinib. Vecabrutinib is currently
being evaluated in a Phase 1b/2 study in adults with chronic
lymphocytic leukemia and other B-cell malignancies that have
progressed after prior therapies. The Company’s proprietary PDK1
inhibitor SNS-510 is in preclinical development. PDK1 is a master
kinase that activates other kinases important to cell growth and
survival including members of the AKT, PKC, RSK, and SGK families.
Sunesis is exploring strategic alternatives for vosaroxin, a
late-stage investigational product for relapsed or refractory AML.
Sunesis also has an interest in the pan-RAF inhibitor TAK-580 which
is licensed to Takeda. TAK-580 is in a clinical trial for pediatric
low-grade glioma.
For additional information on Sunesis, please
visit www.sunesis.com.
SUNESIS and the logos are trademarks
of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking
statements, including statements related to Sunesis’ continued
development of vecabrutinib (SNS-062), including the timing of
Phase 1b/2 trial of vecabrutinib and the therapeutic potential of
vecabrutinib, further development and potential of its kinase
inhibitor pipeline, and sufficiency of its cash resources and
financial position. Words such as “appears”, “expect,” “look
forward,” “will” and similar expressions are intended to identify
forward-looking statements. These forward-looking statements are
based upon Sunesis' current expectations. Forward-looking
statements involve risks and uncertainties. Sunesis' actual results
and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, the
risk related to the timing or conduct of Sunesis' clinical trials,
including the vecabrutinib Phase 1b/2 trial, the risk that Sunesis'
clinical or preclinical studies for vecabrutinib, SNS-510 or other
product candidate may not demonstrate safety or efficacy or lead to
regulatory approval, the risk that data to date and trends may not
be predictive of future data or results, risks related to the
timing or conduct of Sunesis' clinical trials, that Sunesis'
development activities for vecabrutinib or SNS-510 could be
otherwise halted or significantly delayed for various reasons, that
Sunesis may not be able to receive regulatory approval of
vecabrutinib, or SNS-510 in the U.S. or Europe, and risks related
to Sunesis' ability to raise the capital that it believes to be
accessible and is required to fully finance the development and
commercialization of vecabrutinib, SNS-510 and other product
candidates. These and other risk factors are discussed under "Risk
Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q
for the quarter ended March 31, 2019 and Sunesis' other
filings with the Securities and Exchange Commission. Sunesis
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein reflect any change in Sunesis' expectations with
regard thereto or any change in events, conditions or circumstances
on which any such statements are based.
SUNESIS PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
AND COMPREHENSIVE
LOSS |
(In thousands, except per share amounts) |
|
|
|
|
|
Three months ended March 31, |
|
2019 |
|
2018 |
|
(Unaudited) |
Revenue: |
|
|
|
License and other revenue |
$ |
- |
|
|
$ |
237 |
|
Total revenues |
|
- |
|
|
|
237 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
Research and development |
|
3,248 |
|
|
|
3,969 |
|
General and administrative |
|
2,439 |
|
|
|
3,359 |
|
Total operating expenses |
|
5,687 |
|
|
|
7,328 |
|
Loss from operations |
|
(5,687 |
) |
|
|
(7,091 |
) |
Interest expense |
|
(261 |
) |
|
|
(281 |
) |
Other income, net |
|
88 |
|
|
|
99 |
|
Net loss |
|
(5,860 |
) |
|
|
(7,273 |
) |
|
|
|
|
|
|
|
|
Unrealized gain on available-for-sale securities |
|
- |
|
|
|
2 |
|
Comprehensive loss |
$ |
(5,860 |
) |
|
$ |
(7,271 |
) |
|
|
|
|
Basic and diluted loss per common share: |
|
|
|
Net loss |
$ |
(5,860 |
) |
|
$ |
(7,273 |
) |
Shares used in computing basic and diluted loss per common
share |
|
59,142 |
|
|
|
34,345 |
|
Basic and diluted loss per
common share |
$ |
(0.10 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
SUNESIS PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In thousands) |
|
|
|
|
|
March 31, |
|
December 31, |
|
2019 |
|
2018 |
|
(Unaudited) |
|
(1) |
|
|
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
24,811 |
|
|
$ |
13,696 |
|
Prepaids and other current assets |
|
1,599 |
|
|
|
1,504 |
|
Total current assets |
|
26,410 |
|
|
|
15,200 |
|
Property and equipment, net |
|
9 |
|
|
|
11 |
|
Operating lease right-of-use asset |
|
1,226 |
|
|
|
- |
|
Deposits and other assets |
|
109 |
|
|
|
113 |
|
Total assets |
$ |
27,754 |
|
|
$ |
15,324 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
861 |
|
|
$ |
1,393 |
|
Accrued clinical expense |
|
420 |
|
|
|
500 |
|
Accrued compensation |
|
677 |
|
|
|
943 |
|
Other accrued liabilities |
|
1,440 |
|
|
|
1,091 |
|
Notes payable |
|
6,032 |
|
|
|
7,396 |
|
Operating lease liability - current |
|
545 |
|
|
|
- |
|
Total current liabilities |
|
9,975 |
|
|
|
11,323 |
|
Other liabilities |
|
12 |
|
|
|
8 |
|
Operating lease liability - long term |
|
681 |
|
|
|
- |
|
Total liabilities |
|
10,668 |
|
|
|
11,331 |
|
Stockholders’ equity: |
|
|
|
Preferred stock |
|
25,647 |
|
|
|
20,998 |
|
Common stock |
|
7 |
|
|
|
4 |
|
Additional paid-in capital |
|
656,761 |
|
|
|
642,460 |
|
Accumulated deficit |
|
(665,329 |
) |
|
|
(659,469 |
) |
Total stockholders’
equity |
|
17,086 |
|
|
|
3,993 |
|
Total liabilities and stockholders’ equity |
$ |
27,754 |
|
|
$ |
15,324 |
|
|
|
|
|
Note 1: The consolidated balance sheet as of December 31,
2018 has been derived from the audited financial statements as of
that date included in the Company's Annual Report on Form 10-K for
the year ended December 31, 2018. |
Investor and Media Inquiries:Maeve ConneightonArgot
Partners212-600-1902 |
Willie QuinnSunesis Pharmaceuticals Inc.650-266-3716 |
|
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