Sunesis Pharmaceuticals Reports Second Quarter 2018 Financial Results and Recent Highlights
August 07 2018 - 4:05PM
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported
financial results for the quarter ended June 30, 2018. Loss from
operations for the three and six months ended June 30, 2018 was
$6.6 million and $13.7 million. As of June 30, 2018, cash, cash
equivalents and marketable securities totaled $20.4 million. This
capital is expected to fund the company into the first quarter of
2019.
“During the second quarter, we continued to
focus on advancing our Phase 1b/2 trial evaluating our lead
program, the non-covalent BTK inhibitor vecabrutinib, to help
patients who have developed resistance to covalent BTK inhibitors
such as ibrutinib,” said Dayton Misfeldt, Interim Chief Executive
Officer of Sunesis. “Specifically, we have added clinical sites,
including the recent additions of Memorial Sloan Kettering Cancer
Center and Moffitt Cancer Center, and strengthened our development
team. We also entered into a financing facility with Aspire Capital
to provide us with another flexible financing tool to support our
development programs. We expect to present an update on our ongoing
vecabrutinib trial at the annual American Society of Hematology
meeting.”
Recent Highlights
- Strengthened Senior Management Team. In July
2018, the Company announced three key new management appointments
as part of its expanded development team. Deepali Suri, a
former Executive Director at Pharmacyclics (an AbbVie
Company), was appointed Vice President, Clinical Operations
and Sean Gharpurey joined as Executive Director, Project
Management. Stephen Nava was promoted to Vice President,
Quality Assurance, Compliance and Regulatory Affairs.
- Entered into $15.5 Million Common Stock Purchase
Agreement with Aspire Capital Fund, LLC. In June 2018,
Sunesis entered into a Common Stock Purchase Agreement (CSPA) of up
to $15.5 million with Aspire Capital. Under the
terms of the Agreement, Aspire made an initial investment via
purchase of $500,000 worth of SNSS common shares at a
price of $2.19 per common share. In addition, Aspire
committed to purchasing up to an additional $15
million of common shares of Sunesis at Sunesis’ request from
time to time during a 24-month period, at prices based on the
market price at the time of each sale. As consideration for
Aspire’s obligations under the CSPA, Sunesis also issued 212,329
shares of common stock to Aspire as a commitment fee.
- Presented Pre-clinical Data Demonstrating Activity of
Vecabrutinib at EHA Annual Meeting. In June, the
laboratory of Professor Gilles Salles at the
Université Claude Bernard de Lyon presented preclinical
validation of vecabrutinib activity at the
23rd Congress of the European Hematology
Association (EHA) in Stockholm, Sweden. The data
demonstrated the activity of Sunesis’ non-covalent BTK inhibitor
vecabrutinib in BTK-dependent lymphomas, including lymphoma cell
lines overexpressing mutated BTK C481S. In addition, a
Sunesis-supported study led by Professor Paolo Ghia for the
European Research Initiative on CLL (ERIC) assessed the real-world
prevalence of BTK C481 and PLCγ2 mutations in CLL patients
relapsing under ibrutinib. Approximately half of the relapsed
patients had BTK C481S mutations.
Financial Highlights
- Cash, cash equivalents, and marketable securities totaled $20.4
million as of June 30, 2018, as compared to $31.8 million as of
December 31, 2017. This capital is expected to fund the company
into the first quarter of 2019. The 6-month decrease of $11.4
million was primarily due to $12.4 million of net cash used in
operating activities, partially offset by $1.1 million in net cash
flows from financing activities.
- Net cash flows from financing activities comprised $0.8 million
in proceeds from the issuance of common stock and $0.3 million in
proceeds from stock option exercises and ESPP stock purchases.
- Subsequent to June 30, 2018, the Company raised an additional
$2.6 million in net cash proceeds from a combination of the Aspire
CSPA and the Cantor Fitzgerald Controlled Equity Offering
facility.
- Research and development expense was $3.8 million and $7.7
million for the three and six months ended June 30, 2018, as
compared to $4.9 million and $11.1 million for the same periods in
2017, primarily relating to the vecabrutinib and the vosaroxin
development program in each period. The decreases of $1.1 million
and $3.4 million between the comparable periods from last year was
primarily due to decreases in salary and personnel expenses due to
lower headcount, and decrease in professional services and clinical
trials expenses related to higher expenses incurred in the second
quarter of 2017 due to the MAA with the EMA.
- General and administrative expense was $2.8 million and $6.2
million for the three and six months ended June 30, 2018, as
compared to $3.7 million and $7.6 million for the same periods in
2017. The decreases of $0.9 million and $1.4 million between the
comparable periods in 2017 were primarily due to reduced personnel
and commercial expenses.
- Interest expense was $0.3 million and $0.6 million for the
three and six months ended June 30, 2018, as compared to $0.3
million and $0.8 million for the same periods in 2017. The
decreases were primarily due to the decrease in the outstanding
notes payable.
- Cash used in operating activities was $12.4 million for the six
months ended June 30, 2018, as compared to $20.5 million for the
same period in 2017. Net cash used in the 2018 period resulted
primarily from the net loss of $14.1 million, partly offset by net
adjustments for non-cash items of $1.6 million and changes in
operating assets and liabilities of $0.1 million. Net cash used in
the six months ended June 30, 2017, resulted primarily from the net
loss of $18.7 million and changes in operating assets and
liabilities of $3.9 million, partly offset by net adjustments for
non-cash items of $2.1 million.
- Sunesis reported loss from operations of $6.6 million and $13.7
million for the three and six months ended June 30, 2018, as
compared to $8.6 million and $18.0 million for the same periods in
2017. Net loss was $6.8 million and $14.1 million for the
three and six months ended June 30, 2018, as compared to $8.8
million and $18.7 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 5198125. 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 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 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 Sunesis’ proprietary preclinical PDK1
inhibitor SNS-510, which is in preclinical development with an IND
submission planned in 2019, and the Takeda-partnered pan-RAF
inhibitor TAK-580, which is in a clinical trial for pediatric
low-grade glioma. 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 also
seeking a partner to fund the completion of development for
vosaroxin, a Phase 3 investigational product for relapsed or
refractory AML.
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 June 30, 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) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
(Unaudited) |
|
(1) |
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash
equivalents |
$ |
17,028 |
|
|
$ |
26,977 |
|
|
|
Marketable
securities |
|
3,397 |
|
|
|
4,773 |
|
|
|
Prepaids and other
current assets |
|
1,470 |
|
|
|
1,183 |
|
|
|
Total current
assets |
|
21,895 |
|
|
|
32,933 |
|
|
|
Property and equipment,
net |
|
16 |
|
|
|
20 |
|
|
|
Deposits and other
assets |
|
110 |
|
|
|
1,381 |
|
|
|
Total assets |
$ |
22,021 |
|
|
$ |
34,334 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
$ |
1,553 |
|
|
$ |
1,697 |
|
|
|
Accrued clinical
expense |
|
552 |
|
|
|
767 |
|
|
|
Accrued
compensation |
|
955 |
|
|
|
1,440 |
|
|
|
Other accrued
liabilities |
|
1,686 |
|
|
|
1,570 |
|
|
|
Notes payable |
|
7,300 |
|
|
|
7,204 |
|
|
|
Total current
liabilities |
|
12,046 |
|
|
|
12,678 |
|
|
|
Other liabilities |
|
- |
|
|
|
112 |
|
|
|
Commitments |
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
Preferred stock |
|
20,966 |
|
|
|
20,966 |
|
|
|
Common stock |
|
4 |
|
|
|
3 |
|
|
|
Additional paid-in
capital |
|
635,973 |
|
|
|
633,436 |
|
|
|
Accumulated other
comprehensive loss |
|
(1 |
) |
|
|
(7 |
) |
|
|
Accumulated
deficit |
|
(646,967 |
) |
|
|
(632,854 |
) |
|
|
Total stockholders’
equity |
|
9,975 |
|
|
|
21,544 |
|
|
|
Total
liabilities and stockholders’ equity |
$ |
22,021 |
|
|
$ |
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 June
30, |
|
Six months ended June
30, |
|
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
License and other
revenue |
$ |
- |
|
|
$ |
- |
|
|
$ |
237 |
|
|
$ |
669 |
|
|
|
Total
revenues |
|
- |
|
|
|
- |
|
|
|
237 |
|
|
|
669 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
3,758 |
|
|
|
4,941 |
|
|
|
7,727 |
|
|
|
11,103 |
|
|
|
|
General and
administrative |
|
2,824 |
|
|
|
3,671 |
|
|
|
6,183 |
|
|
|
7,613 |
|
|
|
Total
operating expenses |
|
6,582 |
|
|
|
8,612 |
|
|
|
13,910 |
|
|
|
18,716 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(6,582 |
) |
|
|
(8,612 |
) |
|
|
(13,673 |
) |
|
|
(18,047 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense |
|
(287 |
) |
|
|
(344 |
) |
|
|
(568 |
) |
|
|
(828 |
) |
|
|
Other
income, net |
|
29 |
|
|
|
114 |
|
|
|
128 |
|
|
|
199 |
|
|
|
Net
loss |
|
(6,840 |
) |
|
|
(8,842 |
) |
|
|
(14,113 |
) |
|
|
(18,676 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on available-for-sale securities |
|
4 |
|
|
|
9 |
|
|
|
6 |
|
|
|
13 |
|
|
|
Comprehensive loss |
$ |
(6,836 |
) |
|
$ |
(8,833 |
) |
|
$ |
(14,107 |
) |
|
$ |
(18,663 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share: |
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(6,840 |
) |
|
$ |
(8,842 |
) |
|
$ |
(14,113 |
) |
|
$ |
(18,676 |
) |
|
|
|
Shares
used in computing basic and diluted loss per common share |
|
34,417 |
|
|
|
21,521 |
|
|
|
34,381 |
|
|
|
21,276 |
|
|
|
Basic and
diluted loss per common share |
$ |
(0.20 |
) |
|
$ |
(0.41 |
) |
|
$ |
(0.41 |
) |
|
$ |
(0.88 |
) |
|
|
Investor and Media
Inquiries:Maeve ConneightonArgot Partners212-600-1902 |
Willie
QuinnSunesis Pharmaceuticals Inc.650-266-3716 |
|
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