Sunesis Pharmaceuticals Reports First Quarter 2018 Financial Results and Recent Highlights
May 08 2018 - 4:00PM
Sunesis to Host Conference Call Today at 4:30 PM
Eastern Time
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the first quarter ended March 31, 2018. Loss
from operations for the three months ended March 31, 2018 was $7.1
million. As of March 31, 2018, cash, cash equivalents and
marketable securities totaled $25.4 million. This capital is
expected to fund the company into early 2019.
“We remain highly focused on the execution of
our Phase 1b/2 trial evaluating our lead program, the non-covalent
BTK inhibitor vecabrutinib (SNS-062), to help patients who have
developed resistance to covalent BTK inhibitors such as ibrutinib,
the current standard of care in treating CLL,” said Dayton
Misfeldt, Interim Chief Executive Officer of Sunesis. “We believe
vecabrutinib represents an important potential new treatment option
for B-cell hematologic cancers, and we look forward to providing a
data update from the study at a medical meeting in the fall.”
Recent Highlights
- Phase 1b/2 Study Evaluating
Oral Non-Covalent BTK-inhibitor Vecabrutinib (SNS-062) in Adults
with Chronic Lymphocytic Leukemia (CLL) and other B-Cell
Malignancies. Sunesis’ ongoing Phase 1b/2 study is
evaluating the safety, pharmacokinetics, pharmacodynamics, and
antitumor activity of its potent non-covalent BTK-inhibitor
vecabrutinib in adults with CLL and other B cell
malignancies. The Phase 1b portion of the study is an
open-label, dose-escalation study with the goal of determining the
recommended Phase 2 dose. The Phase 2 portion of the study will
explore various cohorts of patients; current cohort concepts
include ibrutinib-resistant patients with C481 mutations. The trial
is enrolling patients who have relapsed/refractory B cell
malignancies after at least 2 lines of standard treatment. For
indications such as CLL with approved BTK inhibitors, one of those
prior treatments must have been a covalent BTK inhibitor. The study
is in the 50 mg cohort. Sunesis expects to reach the recommended
Phase 2 dose in the fall of 2018.
- Appointed Industry Veteran
H. Ward Wolff to the Board of Directors. In February 2018,
H. Ward Wolff was appointed to the Board of Directors. Ward brings
over 40 years of finance and executive leadership experience to the
Board, with 20 years of experience in the life sciences sector,
most recently having served as Executive Vice President and Chief
Financial Officer of Sangamo Therapeutics, Inc. Mr. Wolff is also
designated chairman of the company’s Audit Committee.
Financial Highlights
- Cash, cash equivalents, and
marketable securities totaled $25.4 million as of March 31, 2018,
as compared to $31.8 million as of December 31, 2017. The decrease
of $6.4 million was primarily due to $6.6 million of net cash used
in operating activities, partially offset by $0.2 million in net
proceeds from the exercise of stock options. This capital is
expected to fund the company into early 2019.
- Revenue for the three months ended
March 31, 2018 was $0.2 million as compared to $0.7 million for the
same period in 2017. The decrease between the periods was 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 $4.0 million for the three months ended March 31, 2018, as
compared to $6.2 million for the same period in 2017, primarily
relating to the vecabrutinib and the vosaroxin development program
in each period. The decrease of $2.2 million was primarily due to
$1.7 million decrease in professional services and clinical trials
expenses related to higher expenses incurred in the first quarter
of 2017 due to the preparation for EMA, and $0.3 million decrease
in salary and personnel expenses due to lower headcounts.
- General and administrative expense
was $3.4 million for the three months ended March 31, 2018, as
compared to $3.9 million for the same period in 2017. The decrease
of $0.5 million was primarily due to $0.4 million decrease in
professional services expenses and $0.1 million decrease in
commercial expenses as result of higher expenses incurred in the
first quarter of 2017 due to the preparation for EMA.
- Interest expense was $0.3 million
for the three months ended March 31, 2018, as compared to $0.5
million for the same period in 2017. The decrease was primarily due
to the decrease in the outstanding notes payable.
- Cash used in operating activities
was $6.6 million for the three months ended March 31, 2018, as
compared to $9.7 million for the same period in 2017. Net cash used
in the 2018 period 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. Net cash used in the 2017 period resulted primarily from
the net loss of $9.8 million and changes in operating assets and
liabilities of $0.9 million, partially offset by net adjustments
for non-cash items of $1.0 million.
- Sunesis reported loss from
operations of $7.1 million for the three months ended March 31,
2018, as compared to $9.4 million for the same period in
2017. Net loss was $7.3 million for the three months ended
March 31, 2018, as compared to $9.8 million for the same period in
2017.
Conference Call Information
Sunesis will host a conference call 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 9676198. 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 therapeutics for the treatment of solid and
hematologic cancers. Sunesis has built an experienced cancer 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 establishing proof
of concept that its oral non-covalent BTK-inhibitor vecabrutinib is
effective in ibrutinib-resistant chronic lymphocytic leukemia.
Vecabrutinib is currently being evaluated in a Phase 1b/2 study in
adults with chronic lymphocytic leukemia and other B-cell
malignancies who have progressed after prior therapies. Beyond the
development of vecabrutinib, the Company has two other kinase
inhibitor programs, including the Takeda-partnered pan-RAF
inhibitor TAK-580, which is in clinical trials for solid tumors,
and Sunesis’ proprietary preclinical PDK1 inhibitor SNS-510, which
is in preclinical development with an IND submission planned in
2019. 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.
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. Words such as “believe,” “expect,” “look
forward,” “potential,” “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, 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. |
CONSOLIDATED BALANCE SHEETS |
(In thousands) |
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2018 |
|
|
|
2017 |
|
|
(Unaudited) |
|
|
(1) |
|
|
|
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash
equivalents |
$ |
21,365 |
|
|
$ |
26,977 |
|
Marketable
securities |
|
4,033 |
|
|
|
4,773 |
|
Prepaids and other
current assets |
|
1,480 |
|
|
|
1,183 |
|
Total current
assets |
|
26,878 |
|
|
|
32,933 |
|
Property and equipment,
net |
|
18 |
|
|
|
20 |
|
Deposits and other
assets |
|
96 |
|
|
|
1,381 |
|
Total assets |
$ |
26,992 |
|
|
$ |
34,334 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
1,038 |
|
|
$ |
1,697 |
|
Accrued clinical
expense |
|
570 |
|
|
|
767 |
|
Accrued
compensation |
|
862 |
|
|
|
1,440 |
|
Other accrued
liabilities |
|
1,905 |
|
|
|
1,570 |
|
Notes payable |
|
7,252 |
|
|
|
7,204 |
|
Total current
liabilities |
|
11,627 |
|
|
|
12,678 |
|
Other liabilities |
|
- |
|
|
|
112 |
|
Commitments |
|
|
|
Stockholders’
equity: |
|
|
|
Preferred stock |
|
20,966 |
|
|
|
20,966 |
|
Common stock |
|
3 |
|
|
|
3 |
|
Additional paid-in
capital |
|
634,528 |
|
|
|
633,436 |
|
Accumulated other
comprehensive loss |
|
(5 |
) |
|
|
(7 |
) |
Accumulated
deficit |
|
(640,127 |
) |
|
|
(632,854 |
) |
Total stockholders’
equity |
|
15,365 |
|
|
|
21,544 |
|
Total
liabilities and stockholders’ equity |
$ |
26,992 |
|
|
$ |
34,334 |
|
|
|
|
|
Note
1: 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. |
|
|
|
|
|
|
|
|
|
|
SUNESIS PHARMACEUTICALS, INC. |
|
CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
AND COMPREHENSIVE LOSS |
|
(In thousands, except per share
amounts) |
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2018 |
|
|
2017 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
License
and other revenue |
|
$ |
237 |
|
|
$ |
669 |
|
Total revenues |
|
|
237 |
|
|
|
669 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
3,969 |
|
|
|
6,162 |
|
General
and administrative |
|
|
3,359 |
|
|
|
3,942 |
|
Total operating
expenses |
|
|
7,328 |
|
|
|
10,104 |
|
Loss from
operations |
|
|
(7,091 |
) |
|
|
(9,435 |
) |
Interest expense |
|
|
(281 |
) |
|
|
(484 |
) |
Other income (expense),
net |
|
|
99 |
|
|
|
85 |
|
Net loss |
|
|
(7,273 |
) |
|
|
(9,834 |
) |
Unrealized gain on
available-for-sale securities |
|
|
2 |
|
|
|
4 |
|
Comprehensive loss |
|
$ |
(7,271 |
) |
|
$ |
(9,830 |
) |
Basic and diluted loss
per common share: |
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(7,273 |
) |
|
$ |
(9,834 |
) |
Shares
used in computing basic and diluted |
|
|
|
|
|
|
|
|
loss per common share |
|
|
34,345 |
|
|
|
21,029 |
|
Basic and diluted loss
per common share |
|
$ |
(0.21 |
) |
|
$ |
(0.47 |
) |
|
|
|
Investor and Media
Inquiries:Maeve ConneightonArgot Partners212-600-1902 |
Willie
QuinnSunesis Pharmaceuticals Inc.650-266-3716 |
|
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From Apr 2023 to Apr 2024