Sunesis Pharmaceuticals Reports Third Quarter 2017 Financial Results and Recent Highlights
02 November 2017 - 10:00PM
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the third quarter ended September 30, 2017.
Loss from operations for the three months ended September 30, 2017
was $9.9 million. As of September 30, 2017, cash, cash equivalents
and marketable securities totaled $12.5 million. Subsequent
to the end of the quarter, the company raised approximately $6
million from sales of common stock through its at the market
facility in October 2017 and $20 million in gross proceeds from
concurrent underwritten public offerings on October 27, 2017, which
together will provide sufficient funds for the operation of the
company’s business into early 2019.
“In the third quarter, we advanced our lead
program, a reversible, non-covalent BTK inhibitor, SNS-062, with
the ongoing enrollment in our Phase 1b/2 study in patients with
relapsed chronic lymphocytic leukemia (CLL) and other B-cell
malignancies,” said Daniel Swisher, Chief Executive Officer of
Sunesis. “We will provide a program update at an investor
presentation and webcast during the American Society of Hematology
Conference in Atlanta, Georgia in December 2017, and to present
interim data from the study at a peer-reviewed medical conference
in mid-2018. We believe SNS-062 has the potential to overcome the
leading resistance pathway to ibrutinib, the predominant standard
of care for the treatment of CLL. In addition, in October, we
secured the financial resources from leading life science investors
extending our operating runway into early 2019.
Mr. Swisher added, “Beyond SNS-062, we have made
progress with our proprietary PDK-1 and Takeda-partnered pan-RAF
inhibitor programs. We are pleased to announce today the nomination
of our PDK1 (phosphatidyl-inositol dependent kinase1) inhibitor,
SNS-510, as a Development Candidate and potentially first-to-clinic
selective inhibitor in this pathway. 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.
In addition, we look forward to announcing future updates from the
ongoing clinical studies of our Takeda-partnered TAK-580
program.”
Recent Highlights
- Completed $20 million concurrent public offerings with
leading life science investors. On October 27, 2017,
Sunesis raised $20 million in gross proceeds in concurrent
underwritten public offerings of common and preferred stock and
warrants, with participation by new and existing investors,
including Oncology Impact Fund managed by MPM Capital, BVF Partners
L.P and Burrage Capital.
- Continued Progress in Phase 1b/2 Study Evaluating Oral
Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic
Lymphocytic Leukemia (CLL) and other B-Cell Malignancies.
In July 2017, Sunesis announced that the first patient was dosed at
the Dana-Farber Cancer Institute in the Phase 1b/2 dose-escalation
and cohort-expansion study evaluating the safety, pharmacokinetics,
pharmacodynamics, and antitumor activity of its potent, reversible,
non-covalent BTK-inhibitor, SNS-062, in adults with CLL, small
lymphocytic leukemia, Waldenstrom’s macroglobulinemia, and mantle
cell lymphoma. The Phase 1b/2 trial is an open-label,
sequential-group study that is enrolling up to 124 subjects across
leading sites in the United States. The Company plans to present
interim data from this study in mid-2018.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $12.5
million as of September 30, 2017, as compared to $42.6 million as
of December 31, 2016. The decrease of $30.1 million was
primarily due to $30.8 million of net cash used in operating
activities and a debt restructuring payment of $7.6 million,
partially offset by $8.3 million in net proceeds primarily
from sales of common stock through the company’s at the market
facility. An additional $24.6 million in net
proceeds were raised in October, resulting in pro-forma September
30, 2017 cash, cash equivalents and marketable securities of $37.1
million. This capital is expected to fund the company into
2019.
- Revenue for the three and nine months ended September 30, 2017
was nil and $0.7 million, as compared to $0.6 million and $1.9
million for the same periods in 2016. Revenue in each period
was primarily due to deferred revenue recognized related to the
Royalty Agreement with Royalty Pharma.
- Research and development expense was $6.8 million and $17.9
million for the three and nine months ended September 30, 2017 as
compared to $5.3 million and $18.1 million for the same periods in
2016, primarily relating to the SNS-062 and the vosaroxin
development program in each period. The increase of $1.5 million
between the comparable three month periods was primarily due to the
$2.5 million milestone payment to Biogen under the license
agreement, offset by decreases in professional services of $0.8
million and salary and personnel expenses of $0.2 million. The
decrease in the comparable nine months periods of $0.2 million was
primarily due to a decrease in professional services of $2.5
million, salary and personnel expenses of $0.2 million, and medical
affairs expenses of $0.2 million, partially offset by the $2.5
million milestone payment to Biogen under the license
agreement.
- General and administrative expense was $3.2 million and $10.8
million for the three and nine months ended September 30, 2017, as
compared to $3.9 million and $12.2 million for the same periods in
2016. The decrease of $0.7 million for the comparable three
month periods was primarily due to decreases in salary and
personnel expenses of $0.4 million and commercial expenses of $0.3
million, partially offset by increases of $0.1 million in
professional services. The decrease in the comparable nine months
periods of $1.4 million was primarily due to a decrease in salary
and related expenses of $0.9 million, commercial expenses of $0.7
million, partially offset by increase of $0.4 million in
professional services.
- Interest expense was $0.3 million and $1.1 million for the
three and nine months ended September 30, 2017, as compared to
$0.5 million and $1.2 million for the same periods in 2016.
The decrease in the 2017 periods was primarily due to the decrease
in the outstanding notes payable.
- Net other income was $0.1 million and $0.3 million for the
three and nine months ended September 30, 2017, as compared to nil
and $0.1 million for the same periods in 2016. The other income was
primarily comprised of interest income from the short-term
investments.
- Cash used in operating activities was $30.8 million for the
nine months ended September 30, 2017, as compared to
$29.0 million for the same period in 2016. Net cash used in
the 2017 period resulted primarily from the net loss of $28.8
million and changes in operating assets and liabilities of $4.6
million, offset by net adjustments for non-cash items of $2.6
million. Net cash used in the nine month period ended September 30,
2016 resulted primarily from the net loss of $29.5 million and
changes in operating assets and liabilities of $3.6 million,
including a final payment fee representing interest expense of $1.2
million under the Oxford Loan Agreement, partially offset by net
adjustments for non-cash items of $4.1 million.
- Sunesis reported loss from operations of $9.9 million and $28.0
million for the three and nine months ended September 30, 2017, as
compared to $8.5 million and $28.4 million for the same periods in
2016. Net loss was $10.2 million and $28.8 million for the
three and nine months ended September 30, 2017, as compared to $9.0
million and $29.5 million for the same periods in 2016.
Conference Call Information
Sunesis will host a conference today at 2:00
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 1071001. 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 focused
on the development and commercialization of new oncology
therapeutics for the future 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, SNS-062, is
effective in ibrutinib-resistant chronic lymphocytic
leukemia. SNS-062 is currently being evaluated in a Phase 1b/2,
open-label, sequential-group, dose-escalation and cohort-expansion
study in adults with chronic lymphocytic leukemia, Waldenstrom’s
macroglobulinemia and mantle cell lymphoma that have progressed
after prior therapies. Beyond the development of SNS-062, the
Company has two other kinase inhibitor programs, including the
Takeda-partnered pan-RAF inhibitor TAK-580, which is in solid tumor
trials, and its proprietary preclinical PDK1 inhibitor SNS-510,
which has completed non-GLP toxicology studies and has been
nominated as a Development Candidate. 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 the continued
development of SNS-062, including the timing of our Phase 1b/2
trial of SNS-062 and the therapeutic potential of SNS-062, further
development of its kinase inhibitor pipeline, business development
alternatives for vosaroxin, planned development of SNS-510 and the
sufficiency of Sunesis’ cash and funding into early 2019.
Words such as “continue,” “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
SNS-062 Phase 1b/2 trial, the risk that Sunesis' clinical or
preclinical studies for SNS-062, vosaroxin, 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 SNS-062, vosaroxin or SNS-510 could be
otherwise halted or significantly delayed for various reasons, that
Sunesis may not be able to receive regulatory approval of SNS-062,
vosaroxin 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 SNS-062, vosaroxin, 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 September 30, 2017 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) |
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
(Unaudited) |
|
|
(1) |
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash
equivalents |
$ |
7,947 |
|
|
$ |
8,056 |
|
|
|
Marketable
securities |
|
4,506 |
|
|
|
34,532 |
|
|
|
Prepaids and other
current assets |
|
1,258 |
|
|
|
643 |
|
|
|
Total current
assets |
|
13,711 |
|
|
|
43,231 |
|
|
|
Property and equipment,
net |
|
22 |
|
|
|
3 |
|
|
|
Deposits and other
assets |
|
1,335 |
|
|
|
|
|
Total assets |
$ |
15,068 |
|
|
$ |
43,234 |
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
$ |
1,541 |
|
|
$ |
1,871 |
|
|
|
Accrued clinical
expense |
|
765 |
|
|
|
1,434 |
|
|
|
Accrued
compensation |
|
1,581 |
|
|
|
2,000 |
|
|
|
Other accrued
liabilities |
|
1,056 |
|
|
|
1,691 |
|
|
|
Current portion of
deferred revenue |
|
- |
|
|
|
610 |
|
|
|
Current portion of
notes payable |
|
2,500 |
|
|
|
3,333 |
|
|
|
Total current
liabilities |
|
7,443 |
|
|
|
10,939 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current portion of
notes payable |
|
4,652 |
|
|
|
11,102 |
|
|
|
Other accrued
liabilities |
|
68 |
|
|
|
169 |
|
|
|
Commitments |
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
Preferred stock |
|
16,540 |
|
|
|
18,808 |
|
|
|
Common stock |
|
2 |
|
|
|
2 |
|
|
|
Additional paid-in
capital |
|
612,595 |
|
|
|
599,632 |
|
|
|
Accumulated other
comprehensive income (loss) |
|
(1 |
) |
|
|
(22 |
) |
|
|
Accumulated
deficit |
|
(626,231 |
) |
|
|
(597,396 |
) |
|
|
Total stockholders’
equity |
|
2,905 |
|
|
|
21,024 |
|
|
|
Total
liabilities and stockholders’ equity |
|
15,068 |
|
|
|
43,234 |
|
|
|
|
|
|
|
|
|
Note 1: The consolidated balance sheet as of December 31,
2016 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, 2016. |
|
|
SUNESIS PHARMACEUTICALS, INC. |
|
|
CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
AND COMPREHENSIVE
LOSS |
|
|
(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September
30, |
|
Nine months ended September
30, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Note 2) |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
License
and other revenue |
$ |
- |
|
|
$ |
610 |
|
|
$ |
669 |
|
|
$ |
1,860 |
|
|
|
Total revenues |
|
- |
|
|
|
610 |
|
|
|
669 |
|
|
|
1,860 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
6,763 |
|
|
|
5,251 |
|
|
|
17,866 |
|
|
|
18,066 |
|
|
|
General
and administrative |
|
3,175 |
|
|
|
3,889 |
|
|
|
10,788 |
|
|
|
12,181 |
|
|
|
Total operating
expenses |
|
9,938 |
|
|
|
9,140 |
|
|
|
28,654 |
|
|
|
30,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(9,938 |
) |
|
|
(8,530 |
) |
|
|
(27,985 |
) |
|
|
(28,387 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(288 |
) |
|
|
(473 |
) |
|
|
(1,116 |
) |
|
|
(1,247 |
) |
|
|
Other income (expense),
net |
|
67 |
|
|
|
49 |
|
|
|
266 |
|
|
|
148 |
|
|
|
Net Loss |
|
(10,159 |
) |
|
|
(8,954 |
) |
|
|
(28,835 |
) |
|
|
(29,486 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale securities |
|
8 |
|
|
|
(6 |
) |
|
|
21 |
|
|
|
6 |
|
|
|
Comprehensive loss |
$ |
(10,151 |
) |
|
$ |
(8,960 |
) |
|
$ |
(28,814 |
) |
|
$ |
(29,480 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted loss per common share: |
|
|
|
|
|
|
|
|
|
Net
loss |
$ |
(10,159 |
) |
|
$ |
(8,954 |
) |
|
$ |
(28,835 |
) |
|
$ |
(29,486 |
) |
|
|
Shares
used in computing basic and diluted loss per common share |
|
23,678 |
|
|
|
14,503 |
|
|
|
22,106 |
|
|
|
14,480 |
|
|
|
Basic and diluted loss
per common share |
$ |
(0.43 |
) |
|
$ |
(0.62 |
) |
|
$ |
(1.30 |
) |
|
$ |
(2.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Investor and Media Inquiries:Maeve ConneightonArgot
Partners212-600-1902
Dan SwisherSunesis Pharmaceuticals
Inc.650-266-3715
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From Sep 2024 to Oct 2024
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From Oct 2023 to Oct 2024