Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the third quarter ended September 30, 2016.
Loss from operations for the three months ended September 30, 2016
was $8.5 million. As of September 30, 2016, cash, cash equivalents
and marketable securities totaled $24.3 million.
“Since the beginning of the third quarter we
have made significant progress in advancing both our vosaroxin and
BTK inhibitor programs. In addition, in October, we secured the
financial resources from leading life sciences investors which will
help us reach several potential value inflection points,” said
Daniel Swisher, Chief Executive Officer of Sunesis. “The potential
milestones include a marketing authorization decision on vosaroxin
in Europe, the potential for a corresponding partnership and
product launch in this territory, and the initiation and
prosecution of a Phase 1B/2 study of SNS-062, our differentiated,
non-covalent BTK-inhibitor, in patients with B-cell
malignancies.”
“The European regulatory review of vosaroxin has
now resumed, following our response to the Day 120 List of
Questions, and we look forward to receiving the EMA Day 180 List of
Outstanding Issues before year-end. We were also pleased to present
Phase 1A Healthy Volunteer Study results demonstrating a favorable
safety, pharmacokinetic and pharmacodynamic profile for SNS-062 at
the ESH Conference on New Concepts in B-Cell Malignancies in
September.”
Third Quarter 2016 and Recent Highlights
- Submission of Responses to the EMA Day 120 List of
Questions for the Marketing Authorization Application for
Vosaroxin. In October, Sunesis announced that it submitted
its responses to European Medicines Agency (EMA) Day 120
List of Questions issued by the Committee for Medicinal
Products for Human Use (CHMP) as part of the centralized
review process of the Marketing Authorization Application (MAA) for
vosaroxin based on data from the VALOR trial, as a treatment for
relapsed/refractory acute myeloid leukemia (AML) in patients aged
60 years and older. Sunesis expects to receive the EMA Day 180 List
of Outstanding Issues before year-end.
- Presentation of Dose Escalation Results from the Phase
1A Healthy Volunteer Study Evaluating Oral Non-Covalent BTK
inhibitor SNS-062. In September, Sunesis announced results
from the Company’s Phase 1A study in healthy volunteers evaluating
oral non-covalent BTK inhibitor SNS-062. The study demonstrated a
favorable safety, pharmacokinetic (PK) and pharmacodynamic (PD)
profile for SNS-062 in healthy subjects. The results were presented
on Saturday, September 10th at the European
School of Haematology’s (ESH) 2nd International
Conference on New Concepts in B-Cell Malignancies at the
Estoril Congress Centre in Estoril, Portugal. The
presentation, titled “A Phase 1A Study to Investigate the Safety,
Pharmacokinetics, and Pharmacodynamics of the Noncovalent Bruton
Tyrosine Kinase (BTK) Inhibitor SNS-062 in Healthy Subjects:
Preliminary Results” is 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 Publication in “Drugs” Detailing Molecular
and Pharmacologic Properties of Vosaroxin. In August,
Sunesis announced the publication of an article detailing the
molecular and pharmacologic properties of vosaroxin as a new
therapeutic for acute myeloid leukemia (AML) in the
journal Drugs. Vosaroxin is the first quinolone-based
topoisomerase II inhibitor studied in clinical trials in
oncology. The article, titled “Molecular and Pharmacologic
Properties of the Anticancer Quinolone Derivative Vosaroxin: A New
Therapeutic for Acute Myeloid Leukemia,” is
available online and appeared in the September
2016 print issue of Drugs. The authors describe how the
unique chemical and pharmacologic characteristics of vosaroxin may
contribute to the efficacy and safety profile observed in Sunesis’
Phase 3 VALOR trial in first relapsed or refractory AML.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $24.3
million as of September 30, 2016, as compared to $46.4 million as
of December 31, 2015. The decrease of $22.1 million was primarily
due to $28.9 million of net cash used in operating activities, $8.0
million of payments against notes payable, partially offset by
$14.8 million in net loan proceeds. An additional $25.9
million in net proceeds was raised in the October 2016 equity
financing, resulting in pro-forma September 30, 2016 cash, cash
equivalents and marketable securities of $50.2 million. This
capital is expected to be sufficient to fund operations into
2018.
- Revenue for the three and nine months ended September 30, 2016
was $0.6 million and $1.9 million as compared to $0.7 million and
$2.4 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 expense was $5.3 million and $18.1
million for the three and nine months ended September 30, 2016 as
compared to $5.3 million and $16.1 million for the same periods in
2015. The increase of $2.0 million between the comparable nine
month periods was primarily due to an increase in professional
services, clinical trials and medical affairs expenses.
- General and administrative expense was $3.9 million and $12.2
million for the three and nine months ended September 30, 2016 as
compared to $4.0 million and $14.3 million for the same periods in
2015. The decrease of $0.1 million between the comparable
three month periods was primarily due to a decrease in personnel
expenses. The decrease of $2.1 million between the comparable nine
month periods was primarily due to decrease in outside service
costs.
- Interest expense was $0.5 million and $1.2 million for the
three and nine months ended September 30, 2016 as compared to $0.2
million and $0.7 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 nil and $0.1 million for the three and
nine months ended September 30, 2016 as compared to net other
income of $1.8 million and $3.6 million for the same period in
2015. The decrease in net other income is related to the quarterly
re-valuation of warrant liabilities.
- Cash used in operating activities was $29.0 million for the
nine months ended September 30, 2016, as compared to
$29.5 million for the same period in 2015. Net cash used in
the 2016 period resulted primarily from the net loss of $29.5
million and changes in operating assets and liabilities of $3.6
million, including the payment of a final fee of $1.2 million under
the Oxford Loan Agreement, partially offset by net adjustments for
non-cash items of $4.1 million. Net cash used in the 2015 period
resulted primarily from the net loss of $25.1 million and changes
in operating assets and liabilities of $5.6 million, partially
offset by net adjustments for non-cash items of $1.2 million.
- Sunesis reported loss from operations of $8.5 million and $28.4
million for the three and nine months ended September 30, 2016 as
compared to $8.6 million and $28.0 million for the same periods in
2015. Net loss was $9.0 million and $29.5 million for the
three and nine months ended September 30, 2016, as compared
to $7.0 million and $25.1 million for the same periods in
2015.
Conference Call Information
Sunesis will host an update conference call
today, November 3rd 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 6564483. 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, including the regulatory development and potential
approval of vosaroxin by the EMA, potential collaborations and
ability to commercialize vosaroxin in Europe and clinical
development of SNS-062. Words such as “expect,” “may,” "potential"
“advancing,” “progress” 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 vosaroxin in the U.S.
or Europe, that Sunesis' development activities for 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
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 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, 2015, Sunesis’
Quarterly Report on Form 10-Q for the quarter ended September 30,
2016, when available, 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) |
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash
equivalents |
$ |
5,825 |
|
|
$ |
26,886 |
|
|
|
Marketable
securities |
|
18,427 |
|
|
|
19,544 |
|
|
|
Prepaids and other
current assets |
|
840 |
|
|
|
558 |
|
|
|
Total current
assets |
|
25,092 |
|
|
|
46,988 |
|
|
|
Property and equipment,
net |
|
6 |
|
|
|
14 |
|
|
|
Total assets |
$ |
25,098 |
|
|
$ |
47,002 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
$ |
2,526 |
|
|
$ |
2,453 |
|
|
|
Accrued clinical
expense |
|
1,635 |
|
|
|
1,954 |
|
|
|
Accrued
compensation |
|
1,487 |
|
|
|
1,606 |
|
|
|
Other accrued
liabilities |
|
1,549 |
|
|
|
2,711 |
|
|
|
Current portion of
deferred revenue |
|
1,221 |
|
|
|
2,441 |
|
|
|
Current portion of
notes payable |
|
2,083 |
|
|
|
7,834 |
|
|
|
Total current
liabilities |
|
10,501 |
|
|
|
18,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current portion of
deferred revenue |
|
- |
|
|
|
610 |
|
|
|
|
|
|
|
|
|
|
|
Non-current other
accrued liabilities |
|
113 |
|
|
|
|
|
Non-current portion of
notes payable |
|
12,273 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Commitments |
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
Preferred stock |
|
16,459 |
|
|
|
16,459 |
|
|
|
Common stock |
|
1 |
|
|
|
1 |
|
|
|
Additional paid-in
capital |
|
574,615 |
|
|
|
570,317 |
|
|
|
Accumulated other
comprehensive income (loss) |
|
(5 |
) |
|
|
(11 |
) |
|
|
Accumulated
deficit |
|
(588,859 |
) |
|
|
(559,373 |
) |
|
|
Total stockholders’
equity |
|
2,211 |
|
|
|
27,393 |
|
|
|
Total liabilities and
stockholders’ equity |
$ |
25,098 |
|
|
$ |
47,002 |
|
|
|
|
|
|
|
|
|
Note 1: The consolidated balance sheet as of December 31,
2015 (as adjusted for the Reverse Split), 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 September
30, |
|
Nine months ended September
30, |
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Note 2) |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
License and other
revenue |
$ |
610 |
|
|
$ |
683 |
|
|
$ |
1,860 |
|
|
$ |
2,391 |
|
|
|
Total
revenues |
|
610 |
|
|
|
683 |
|
|
|
1,860 |
|
|
|
2,391 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
5,251 |
|
|
|
5,259 |
|
|
|
18,066 |
|
|
|
16,073 |
|
|
|
|
General and administrative |
|
3,889 |
|
|
|
3,994 |
|
|
|
12,181 |
|
|
|
14,280 |
|
|
|
Total
operating expenses |
|
9,140 |
|
|
|
9,253 |
|
|
|
30,247 |
|
|
|
30,353 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(8,530 |
) |
|
|
(8,570 |
) |
|
|
(28,387 |
) |
|
|
(27,962 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense |
|
(473 |
) |
|
|
(233 |
) |
|
|
(1,247 |
) |
|
|
(705 |
) |
|
|
Other
income (expense), net |
|
49 |
|
|
|
1,782 |
|
|
|
148 |
|
|
|
3,569 |
|
|
|
Net loss |
|
(8,954 |
) |
|
|
(7,021 |
) |
|
|
(29,486 |
) |
|
|
(25,098 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale securities |
|
(6 |
) |
|
|
3 |
|
|
|
6 |
|
|
|
5 |
|
|
|
Comprehensive loss |
$ |
(8,960 |
) |
|
$ |
(7,018 |
) |
|
$ |
(29,480 |
) |
|
$ |
(25,093 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share: |
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(8,954 |
) |
|
$ |
(7,021 |
) |
|
$ |
(29,486 |
) |
|
$ |
(25,098 |
) |
|
|
|
Shares
used in computing basic and diluted loss per common share |
|
14,503 |
|
|
|
12,463 |
|
|
|
14,480 |
|
|
|
11,945 |
|
|
|
Basic and
diluted loss per common share |
$ |
(0.62 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.04 |
) |
|
$ |
(2.10 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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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