Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2018 Financial Results and Recent Highlights
March 07 2019 - 3:01PM
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported
financial results for the fourth quarter and year ended December
31, 2018. Loss from operations for the three months and year ended
December 31, 2018 was $5.8 million and $25.7 million. As of
December 31, 2018, cash and cash equivalents totaled $13.7 million.
Subsequent to the end of the quarter, the company raised $20
million in gross proceeds from concurrent underwritten public
offerings in January.
“We began 2019 by announcing the move into the
100 mg cohort for our Phase 1b/2 trial of vecabrutinib, an
important milestone as we continue to believe that 100 – 300 mg
will be the potentially therapeutic dose levels,” said Dayton
Misfeldt, Interim Chief Executive Officer of Sunesis. “To date, we
have seen an encouraging safety profile, evidence of
pharmacodynamic activity and some improvements in clinical symptoms
in CLL and other B cell cancer patients both with and without BTK
C481 mutations. We are targeting an update on our ongoing
vecabrutinib trial at the European Hematology Association Congress
(EHA) in June 2019. In addition, in January, we completed an equity
offering with leading biotechnology investors that extends our
runway through important clinical milestones.”
Recent Highlights
- Announced Advancement into 100mg Cohort. In
January 2019, the Company announced that it had opened the 100 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.The latest protocol
amendment, approved by most sites in February 2019, allows for
upfront enrollment of up to 6 evaluable patients into a cohort, and
we have taken advantage of this to allocate additional slots for
the 100mg cohort. By studying more patients and collecting more
data, we can better characterize vecabrutinib’s profile at this
dose level.
- Completion of $20 Million Financing. In
January, Sunesis announced the completion of an equity financing
with net proceeds of approximately $18.4 million. The financing
attracted participation from leading biotechnology investors and
will allow Sunesis to advance vecabrutinib through important
clinical milestones as we explore the potentially active dose
levels.
- Presentation of Preliminary Data at the ASH Annual
Meeting. In December 2018, Sunesis presented preliminary
data from the Phase 1b/2 clinical trial of its non-covalent BTK
inhibitor vecabrutinib in adults with relapsed/refractory chronic
lymphocytic leukemia (CLL) and other B-cell malignancies.
Financial Highlights
- Cash and cash equivalents totaled $13.7 million as of December
31, 2018, as compared to $31.8 million as of December 31, 2017. The
decrease of $18.1 million was primarily due to $24.4 million of net
cash used in operating activities, partially offset by $6.3 million
in net proceeds from issuance of common stock.
- Revenue was $0.2 million in 2018 as compared to $0.7 million in
2017, primarily due to deferred revenue related to the Royalty
Agreement with RPI Finance Trust, which was fully amortized to
revenue in March 2017.
- Research and development expense was $3.3 million and $14.6
million for the three months and year ended December 31, 2018, as
compared to $3.7 million and $21.5 million for the same periods in
2017. The decreases in 2018 were primarily due to the 2017 $2.5
million Biogen payment, a $2.8 million decrease in professional
services related to the 2017 vosaroxin regulatory filing with the
European Medicines Agency, and a $1.8 million decrease in salary
and related expenses, partially offset by an increase in clinical
expenses of $0.5 million for work related to the development of
vecabrutinib.
- General and administrative expense was $2.5 million and $11.3
million for the three months and year ended December 31, 2018, as
compared to $2.8 million and $13.5 million for the same periods in
2017. The decreases in 2018 were primarily due to a $1.4 million
decrease in professional services, a $0.5 million decrease in
salary and related expenses, and a $0.3 million decrease in
vosaroxin commercial expenses.
- Interest expense was $0.3 million and $1.2 million for the
three months and year ended December 31, 2018, as compared to $0.3
million and $1.4 million for the same periods in 2017. The decrease
in 2018 was primarily due to the decrease in the outstanding notes
payable.
- Cash used in operating activities was $24.4 million for the
year ended December 31, 2018, as compared to $36.1 million for the
same period in 2017. Net cash used in operating activities in 2018
resulted primarily from the net loss of $26.6 million and changes
in operating assets and liabilities of $0.6 million, offset by net
adjustments for non-cash items of $2.8 million.
- Loss from operations was $5.8 million and $25.7 million for the
three months and year ended December 31, 2018, as compared to $6.4
million and $34.4 million for the same periods in 2017. Net
loss was $6.0 million and $26.6 million for the three months and
year ended December 31, 2018, as compared to $6.6 million and $35.5
million for the same periods in 2017.
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 6225859. 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’ cash
sufficiency forecast, the 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 planned
development of SNS-510 and TAK-580. Words such as “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' Annual Report on Form 10-K for
the year ended December 31, 2018 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 endedDecember
31, |
|
|
Twelve months endedDecember
31, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(Note 1) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License
and other revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
237 |
|
|
$ |
669 |
|
Total revenues |
|
|
— |
|
|
|
— |
|
|
|
237 |
|
|
|
669 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
3,301 |
|
|
|
3,674 |
|
|
|
14,615 |
|
|
|
21,540 |
|
General
and administrative |
|
|
2,459 |
|
|
|
2,760 |
|
|
|
11,332 |
|
|
|
13,548 |
|
Total operating
expenses |
|
|
5,760 |
|
|
|
6,434 |
|
|
|
25,947 |
|
|
|
35,088 |
|
Loss from
operations |
|
|
(5,760 |
) |
|
|
(6,434 |
) |
|
|
(25,710 |
) |
|
|
(34,419 |
) |
Interest
expense |
|
|
(295 |
) |
|
|
(280 |
) |
|
|
(1,154 |
) |
|
|
(1,396 |
) |
Other
income, net |
|
|
58 |
|
|
|
91 |
|
|
|
249 |
|
|
|
357 |
|
Net loss |
|
|
(5,997 |
) |
|
|
(6,623 |
) |
|
|
(26,615 |
) |
|
|
(35,458 |
) |
Unrealized gain (loss) on available-for-sale securities |
|
|
— |
|
|
|
(6 |
) |
|
|
7 |
|
|
|
15 |
|
Comprehensive loss |
|
$ |
(5,997 |
) |
|
$ |
(6,629 |
) |
|
$ |
(26,608 |
) |
|
$ |
(35,443 |
) |
Basic and diluted loss
per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(5,997 |
) |
|
$ |
(6,623 |
) |
|
$ |
(26,615 |
) |
|
$ |
(35,458 |
) |
Shares
used in computing basic and diluted loss per common share |
|
|
37,438 |
|
|
|
31,667 |
|
|
|
35,582 |
|
|
|
24,516 |
|
Basic and diluted loss
per common share |
|
$ |
(0.16 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.75 |
) |
|
$ |
(1.45 |
) |
Note 1: The consolidated statement of operations
and comprehensive loss for the year ended December 31,
2017 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, 2017.
SUNESIS PHARMACEUTICALS, INC. |
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
|
|
(Unaudited) |
|
|
(Note 2) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
13,696 |
|
|
$ |
26,977 |
|
Marketable securities |
|
|
— |
|
|
|
4,773 |
|
Prepaids
and other current assets |
|
|
1,504 |
|
|
|
1,183 |
|
Total current
assets |
|
|
15,200 |
|
|
|
32,933 |
|
Property
and equipment, net |
|
|
11 |
|
|
|
20 |
|
Other
assets |
|
|
113 |
|
|
|
1,381 |
|
Total assets |
|
$ |
15,324 |
|
|
$ |
34,334 |
|
LIABILITIES AND
STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,393 |
|
|
$ |
1,697 |
|
Accrued
clinical expense |
|
|
500 |
|
|
|
767 |
|
Accrued
compensation |
|
|
943 |
|
|
|
1,440 |
|
Other
accrued liabilities |
|
|
1,091 |
|
|
|
1,570 |
|
Notes
payable |
|
|
7,396 |
|
|
|
7,204 |
|
Total current
liabilities |
|
|
11,323 |
|
|
|
12,678 |
|
Other
liabilities |
|
|
8 |
|
|
|
112 |
|
Total liabilities |
|
|
11,331 |
|
|
|
12,790 |
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Preferred
stock |
|
|
20,998 |
|
|
|
20,966 |
|
Common
stock |
|
|
4 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
642,460 |
|
|
|
633,436 |
|
Accumulated other comprehensive loss |
|
|
— |
|
|
|
(7 |
) |
Accumulated deficit |
|
|
(659,469 |
) |
|
|
(632,854 |
) |
Total stockholders’
equity |
|
|
3,993 |
|
|
|
21,544 |
|
Total liabilities and
stockholders’ equity |
|
$ |
15,324 |
|
|
$ |
34,334 |
|
|
|
|
|
|
|
|
|
|
Note
2: The consolidated balance sheet as of December 31, 2017 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, 2017. |
|
Investor and Media Inquiries:Maeve ConneightonArgot
Partners212-600-1902Willie QuinnSunesis Pharmaceuticals
Inc.650-266-3716
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