Sunesis to Host Conference Call Today at 11:00 AM
Eastern Time
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the fourth quarter and year ended December
31, 2016. Loss from operations for the three months and year ended
December 31, 2016 was $8.1 million and $36.5 million, respectively.
As of December 31, 2016, cash, cash equivalents and marketable
securities totaled $42.6 million.
“We are making meaningful progress in advancing
our two lead programs, vosaroxin and SNS-062, in areas of unmet
need in hematologic malignancies,” said Daniel Swisher, Chief
Executive Officer of Sunesis. “Our European Marketing Authorization
Application is on track; we are working diligently to submit
responses this quarter to the Day 180 List of Outstanding Issues
and we are preparing to go before the Scientific Advisory Group’s
Oncology Division (SAG-O) in April, culminating in a likely CHMP
decision by mid-year. We continue, in parallel, to advance active
dialogues with potential pharma collaborators toward the goal of
supporting a potential market launch of vosaroxin in Europe in the
second half of this year.”
Mr. Swisher continued, “Our BTK inhibitor
program is advancing as planned. The IND for SNS-062 is now active
and we expect to initiate a Phase 1B/2 study in patients with
advanced B-cell malignancies in the second quarter. We were
encouraged by the data from the Phase 1A Healthy Volunteer study
and the level of interest generated at our ASH 2016
presentation.”
Fourth Quarter 2016 and Recent Highlights
- Continued Progress with the Marketing Authorization
Application (MAA) for Vosaroxin in Europe. In January,
Sunesis announced that it had received the Day 180 List of
Outstanding Issues from the European Medicines Agency (EMA), issued
by the Committee for Medicinal Products for Human Use (CHMP) as
part of the centralized review process. The Company plans to submit
its response to the list by the end of the first quarter. In
addition, the Company announced that it will go before
the Scientific Advisory Group’s Oncology Division (SAG-O) in
April, which will assist the CHMP in its evaluation of the
MAA. Sunesis anticipates an approval decision on vosaroxin by
mid-year.
- Announced Active IND for SNS-062 and Trial Initiation
Plans in Phase 1B/2 Study in Patients with Advanced B-Cell
Malignancies. In January, Sunesis announced that its
Investigational New Drug (IND) application with the U.S. Food
and Drug Administration (FDA) was active, supporting the
initiation of a Phase 1B/2 study to assess the candidate's safety
and efficacy in patients with advanced B-cell malignancies after
prior ibrutinib exposure, including in patients with C481S
mutations. Phase 1A of the study examined the safety,
pharmacodynamics, and pharmacokinetics of SNS-062 and was completed
during the fourth quarter of 2016, and the Company plans to begin
dosing patients in the Phase 1B/2 study within the first half of
2017.
- Announced Poster Presentation on BTK Inhibitor SNS-062
at the AACR Annual Meeting. Today, Sunesis announced a
poster presentation at the American Association for Cancer Research
2017 Annual Meeting to be held April 1-5 in Washington, D.C. The
poster, titled “SNS-062 demonstrates efficacy in chronic
lymphocytic leukemia in vitro and inhibits C481S mutated Bruton
tyrosine kinase” (Poster Number 22, Abstract Number 1207,
Convention Center, Halls A-C, Poster Section 6), details results
from an Ohio State University-sponsored preclinical study,
conducted in collaboration with Sunesis, that examines the potency
of SNS-062 versus ibrutinib and acalabrutinib, specifically
relating to the C481S mutation. The results will be presented in a
session titled “Reversal of Drug Resistance” on Monday, April 3,
2017 from 8:00 AM to 12:00 PM Eastern Time.
- Presentation of Updated Results from the VALOR Trial
Evaluating Vosaroxin in AML and Completed Phase 1A Healthy
Volunteer Study Evaluating Oral Non-Covalent BTK Inhibitor SNS-062
at ASH Annual Meeting. In December 2016, Sunesis presented
updated results from the VALOR Trial examining overall survival in
patients age 60 years and older with relapsed/refractory acute
myeloid leukemia (AML), as well results from the Company’s Phase 1A
study in healthy volunteers evaluating oral non-covalent reversible
BTK inhibitor SNS-062 at the 58th American Society of Hematology
Annual Meeting in San Diego, California. The oral presentation,
titled “Durable Overall Survival Benefit in Patients ≥ 60 Years
with Relapsed or Refractory AML Treated with Vosaroxin/Cytarabine
Vs Placebo/Cytarabine: Updated Results from the Valor Trial” and
the poster titled “First-in-Human Phase 1a Study of the Safety,
Pharmacokinetics, and Pharmacodynamics of the Noncovalent Bruton’s
Tyrosine Kinase (BTK) Inhibitor SNS-062 in Healthy Subjects,” are
available on the Sunesis website
at www.sunesis.com.
- Completion of $25.9 million Financing. In
October, Sunesis announced the completion of an equity financing
with net proceeds of $25.9 million. The financing attracted
participation from leading biotechnology investors.
- Announced Organizational Updates. Today,
Sunesis announced two management additions, Judy Fox Ph.D., to the
position of Chief Scientific Officer and Pietro Taverna, Ph.D. to
Executive Director, Translational Medicine. Dr. Fox brings over 25
years of experience both as a scientist and program leader at
leading life science companies. At Sunesis, she and her team will
develop and implement strategic research roadmaps to support the
advancement of Sunesis’ product portfolio. She obtained her Ph.D.
in Biological Chemistry from M.I.T. Pietro Taverna, Ph.D.
returns to Sunesis from Astex/Otsuka Pharmaceuticals, where he led
the Translational Pharmacology department and was responsible for
biomarker strategy and the translation of research insights into
optimal clinical development. He holds a Ph.D. from M. Negri
Institute for Pharmacological Research in Milan.
Additionally, Jennifer Troia was promoted to Vice President, Human
Resources. Jennifer brings over 25 years of related HR
experience, including at Gilead Sciences, COR Therapeutics,
CoMentis and Sunesis.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $42.6
million as of December 31, 2016, as compared to $46.4 million as of
December 31, 2015. The decrease of $3.8 million was primarily due
to $37 million of net cash used in operating activities and $7.2
million of final payments against notes payable and $0.8 million of
principal payments against notes payable, partially offset by net
proceeds of $25.9 million from the underwritten offering and $14.8
million in net loan proceeds, and $0.3 million from the sale of our
common stock through the Sales Agreement with Cantor and exercise
of stock options.
- Revenues for the three months and year ended December 31, 2016
were $0.7 million and $2.5 million, as compared to $0.7 million and
$3.1 million for the same periods in 2015. The decrease between the
periods was primarily due to the extension of the amortization
period of our deferred revenue.
- Research and development expenses were $4.8 million and $22.9
million for the three months and year ended December 31, 2016, as
compared to $7.6 million and $23.7 million for the same periods in
2015. The decrease of $0.8 million in 2016 was primarily due to a
decrease of $2.2 million in personnel costs partially offset by
increases in professional services, clinical trials and medical
affairs expenses.
- General and administrative expenses for the three months and
year ended December 31, 2016 were $3.9 million and $16 million, as
compared to $4.4 million and $18.7 million for the same periods in
2015. The decrease of $2.6 million in 2016 was
primarily due to decrease in professional services and personnel
costs.
- Interest expense was $0.5 million and $1.7 million for the
three months and year ended December 31, 2016, as compared to $0.2
million and $0.9 million for the same periods in 2015. The
increases in the 2016 periods were primarily due to the increase in
the notes payable.
- Net other income was $0.2 million in 2016 as compared to $3.6
million in 2015. The 2015 amount was primarily comprised of net
non-cash credit for the revaluation of warrants issued in the 2010
Offering.
- Cash used in operating activities was $37.0 million for the
year ended December 31, 2016, as compared to $38.7 for the same
period in 2015. Net cash used in operating activities in 2016
resulted primarily from the net loss of $38.0 million and net
adjustment for the non-cash items of $5.2 million offset by changes
in operating assets and liabilities of $4.1 million (including $2.4
million related to recognition of deferred revenue under the
Royalty Agreement).
- Sunesis reported loss from operations of $8.1 million and $36.5
million for the three months and year ended December 31, 2016, as
compared to $11.3 million and $39.3 million for the same periods in
2015. Net loss was $8.5 million and $38.0 million for the three
months and year ended December 31, 2016, as compared to $11.6
million and $36.7 million for the same periods in 2015.
Conference Call Information
Sunesis will host an update conference call
today, March 9th at 11:00 a.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 59899543. 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 QINPREZO™ (vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer
quinolone derivative (AQD), a class of compounds that has not been
used previously for the treatment of cancer. Preclinical data
demonstrate that vosaroxin both intercalates DNA and inhibits
topoisomerase II, resulting in replication-dependent,
site-selective DNA damage, G2 arrest and apoptosis. Both the U.S.
Food and Drug Administration (FDA) and European Commission have
granted orphan drug designation to vosaroxin for the treatment of
AML. Additionally, vosaroxin has been granted fast track
designation by the FDA for the potential treatment of
relapsed/refractory AML in combination with cytarabine. Vosaroxin
is an investigational drug that has not been approved for use in
any jurisdiction.
Vosaroxin’s Marketing Authorization Application
for relapsed refractory AML is currently under review by the
European Medicines Agency, and a regulatory decision regarding
approval is expected in 2017.
The trademark name QINPREZO is conditionally
accepted by the FDA and the EMA as the proprietary name for the
vosaroxin drug product candidate.
About SNS-062
SNS-062 is a novel, second-generation BTK
inhibitor, a class of kinase inhibitors that selectively inhibits
the enzyme Bruton's tyrosine kinase (BTK). This target
mediates signaling through the B-cell receptor, which is critical
for adhesion, migration, proliferation and survival of normal and
malignant B-lineage lymphoid cells. Unlike other drugs in its
class, SNS-062 has a distinct kinase selectivity profile and binds
non-covalently to the BTK enzyme. This alternate binding site
potentially provides an opportunity to address the leading
resistance mechanism, a mutation in the enzyme’s binding site
required for covalent binding. In preclinical studies, SNS-062
demonstrated potent activity against Cys-481S mutated B-cell
malignancies, and has been studied in healthy subjects in a Phase
1A, randomized, double-blind, placebo-controlled dose-ranging study
to investigate the drug’s safety, pharmacokinetics, and
pharmacodynamics. With the reported successful study outcome,
SNS-062 is proceeding to a Phase 1B/2 study in patients with B-cell
malignancies.
About Sunesis
Pharmaceuticals
Sunesis is a biopharmaceutical company focused
on the development and commercialization of new oncology
therapeutics for the potential treatment of solid and hematologic
cancers. Sunesis has built a highly experienced cancer drug
development organization committed to improving the lives of people
with cancer. Currently, the company is focused on pursuing
regulatory approval in Europe for its lead product candidate,
vosaroxin, for the treatment of relapsed or refractory acute
myeloid leukemia in patients aged 60 and older, as well as
advancing its novel kinase-inhibitor pipeline, which includes its
proprietary non-covalent BTK-inhibitor, SNS-062.
For additional information on Sunesis, please
visit http://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' corporate
objectives, the regulatory development, timing of SNS-062 clinical
development, SNS-062 clinical potential, Sunesis’ response to Day
180 List of Outstanding Issues and the timing thereof, and
potential approval of vosaroxin by the EMA, potential
collaborations and ability to commercialize vosaroxin
in Europe. Words such as “advancing,” “anticipate,” “expect,”
“goal,” "potential,” “progress,” “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 that
Sunesis may not be able to receive regulatory approval of SNS-062
or vosaroxin in the U.S. or Europe, that Sunesis' development
activities for SNS-062 or vosaroxin could be otherwise halted or
significantly delayed for various reasons, risks related to
Sunesis' need for substantial additional funding to complete the
development and commercialization of SNS-062, vosaroxin and other
product candidates, the risk that Sunesis' clinical studies for
SNS-062, vosaroxin or other product candidates, including its
pipeline of kinase inhibitors, 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 conduct of Sunesis' clinical trials, 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 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, 2016 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 to 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) |
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2016 |
|
2015 |
|
|
ASSETS |
(Unaudited) |
|
(Note 1) |
|
|
Current assets: |
|
|
|
|
|
Cash and cash
equivalents |
$ |
8,056 |
|
|
$ |
26,886 |
|
|
|
Marketable
securities |
|
34,532 |
|
|
|
19,544 |
|
|
|
Prepaids and other
current assets |
|
643 |
|
|
|
558 |
|
|
|
Total current
assets |
|
43,231 |
|
|
|
46,988 |
|
|
|
Property and equipment,
net |
|
3 |
|
|
|
14 |
|
|
|
Total assets |
$ |
43,234 |
|
|
$ |
47,002 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
$ |
1,871 |
|
|
$ |
2,453 |
|
|
|
Accrued clinical
expense |
|
1,434 |
|
|
|
1,954 |
|
|
|
Accrued
compensation |
|
2,000 |
|
|
|
1,606 |
|
|
|
Other accrued
liabilities |
|
1,691 |
|
|
|
2,711 |
|
|
|
Current portion of
deferred revenue |
|
610 |
|
|
|
2,441 |
|
|
|
Current portion of
notes payable |
|
3,333 |
|
|
|
7,834 |
|
|
|
Total current
liabilities |
|
10,939 |
|
|
|
18,999 |
|
|
|
Non-current portion of
deferred revenue |
|
- |
|
|
|
610 |
|
|
|
Non-current portion of
notes payable |
|
11,102 |
|
|
|
|
|
|
|
Non-current other
liabilities |
|
169 |
|
|
|
|
|
|
|
Commitments |
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
Convertible preferred
stock |
|
18,808 |
|
|
|
16,459 |
|
|
|
Common stock |
|
2 |
|
|
|
1 |
|
|
|
Additional paid-in
capital |
|
599,632 |
|
|
|
570,317 |
|
|
|
Accumulated other
comprehensive loss |
|
(22 |
) |
|
|
(11 |
) |
|
|
Accumulated
deficit |
|
(597,396 |
) |
|
|
(559,373 |
) |
|
|
Total stockholders’
equity |
|
21,024 |
|
|
|
27,393 |
|
|
|
Total liabilities and
stockholders’ equity |
|
43,234 |
|
|
|
47,002 |
|
|
|
|
|
|
|
|
|
Note 1: The consolidated balance sheet as of December 31,
2015 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, 2015. |
|
|
SUNESIS PHARMACEUTICALS, INC. |
|
|
CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
|
AND COMPREHENSIVE
LOSS |
|
|
(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
Three months ended December
31, |
|
Year ended December
31, |
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Note 2) |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
License and other revenue |
$ |
676 |
|
|
$ |
670 |
|
|
$ |
2,536 |
|
|
$ |
3,061 |
|
|
|
Total
revenues |
|
676 |
|
|
|
670 |
|
|
|
2,536 |
|
|
|
3,061 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
4,815 |
|
|
|
7,628 |
|
|
|
22,881 |
|
|
|
23,701 |
|
|
|
General and administrative |
|
3,934 |
|
|
|
4,382 |
|
|
|
16,115 |
|
|
|
18,662 |
|
|
|
Total
operating expenses |
|
8,749 |
|
|
|
12,010 |
|
|
|
38,996 |
|
|
|
42,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(8,073 |
) |
|
|
(11,340 |
) |
|
|
(36,460 |
) |
|
|
(39,302 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense |
|
(474 |
) |
|
|
(234 |
) |
|
|
(1,721 |
) |
|
|
(939 |
) |
|
|
Other
income (expense), net |
|
10 |
|
|
|
(4 |
) |
|
|
158 |
|
|
|
3,565 |
|
|
|
Net loss |
|
|
(8,537 |
) |
|
|
(11,578 |
) |
|
|
(38,023 |
) |
|
|
(36,676 |
) |
|
|
Unrealized gain (loss) on available-for-sale securities |
|
(9 |
) |
|
|
(9 |
) |
|
|
(11 |
) |
|
|
(4 |
) |
|
|
Comprehensive loss |
$ |
(8,546 |
) |
|
$ |
(11,587 |
) |
|
$ |
(38,034 |
) |
|
$ |
(36,680 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss: |
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
(8,537 |
) |
|
$ |
(11,578 |
) |
|
$ |
(38,023 |
) |
|
$ |
(36,676 |
) |
|
|
Diluted |
$ |
(8,537 |
) |
|
$ |
(11,578 |
) |
|
$ |
(38,023 |
) |
|
$ |
(36,676 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net loss per common share: |
|
|
|
|
|
|
|
|
|
Basic |
|
19,285 |
|
|
|
12,781 |
|
|
|
15,688 |
|
|
|
15,688 |
|
|
|
Diluted |
|
19,285 |
|
|
|
12,781 |
|
|
|
15,688 |
|
|
|
15,688 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per common share: |
|
|
|
|
|
|
|
|
|
Basic |
$ |
(0.44 |
) |
|
$ |
(0.91 |
) |
|
$ |
(2.42 |
) |
|
$ |
(2.34 |
) |
|
|
Diluted |
$ |
(0.44 |
) |
|
$ |
(0.91 |
) |
|
$ |
(2.42 |
) |
|
$ |
(2.34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 2:
The consolidated statement of operations and comprehensive loss for
the year ended December 31, 2015 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,
2015. |
|
|
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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