Sunesis Pharmaceuticals Reports Third Quarter 2018 Financial Results and Recent Highlights
November 05 2018 - 4:05PM
Sunesis to Host Conference Call Today at
4:30 PM Eastern Time
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported
financial results for the quarter ended September 30, 2018. Loss
from operations for the three and nine months ended September 30,
2018 was $6.3 million and $20.0 million. As of September 30, 2018,
cash and cash equivalents totaled $20.2 million. This capital is
expected to fund the company into the second quarter of 2019.
“We remain focused on advancing our 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. “We
continue to learn more about this unique asset and its market
opportunity and will share an update at the ASH Annual Meeting in
December. As announced last week, one of our accepted abstracts for
presentation at ASH includes an update on the Phase 1b/2 trial of
vecabrutinib, and as presented in the published abstract, the
pharmacokinetic profile is consistent with the results from our
Phase 1a study. We continue to believe that 100mg to 300mg will be
the potentially active dose levels. Thus far, vecabrutinib appears
well tolerated in the context of advanced disease. We continue with
the dose escalation part of the trial and look forward to sharing a
complete clinical update at the meeting next month and at a
company-sponsored webcast event concurrent with the meeting.”
Recent Highlights
- Announced Presentations at
ASH Annual Meeting. In November 2018, the Company
announced that three presentations will be made at the 60th
American Society of Hematology (ASH) Annual Meeting to be held
December 1-4, 2018 in San Diego, California. Among the abstracts is
an update on the Phase 1b/2 trial of vecabrutinib, titled
“Preliminary Safety, Pharmacokinetic, and Pharmacodynamic Results
from a Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the
Noncovalent, Reversible Bruton's Tyrosine Kinase Inhibitor (BTKi),
Vecabrutinib, in B-Lymphoid Malignancies,” (Publication 3141) which
will be presented on Sunday, December 2, in a session titled “CLL:
Therapy, excluding Transplantation: Poster II,” (Session 642) from
6:00-8:00pm at the San Diego Convention Center, Hall GH. The other
poster, titled “Vecabrutinib Is Efficacious In Vivo in a
Preclinical CLL Adoptive Transfer Model” will be presented on
Saturday, December 1, and an oral presentation “High Prevalence of
BTK Mutations on Ibrutinib Therapy after 3 Years of Treatment in a
Real-Life Cohort of CLL Patients: A Study from the French
Innovative Leukemia Organization (FILO) Group” will be presented in
sessions on Monday, December 3. The posters will be available on
the Sunesis website following the presentations.
- Expanded Clinical Trial
Sites. In the third quarter, we added three additional
clinical sites to our Phase 1b/2 trial: Memorial Sloan Kettering
Cancer Center, Moffitt Cancer Center and University California San
Diego. We continue to identify and prepare for adding additional
sites as we continue dose escalation and prepare for the Phase 2
expansion portion of the study.
Financial Highlights
- Cash and cash equivalents totaled
$20.2 million as of September 30, 2018, as compared to $31.8
million in cash, cash equivalents, and marketable securities as of
December 31, 2017. This capital is expected to fund the company
into the second quarter of 2019. The nine-month decrease of $11.6
million was primarily due to $17.9 million of net cash used in
operating activities, partially offset by $6.3 million in net cash
flows from financing activities.
- Research and development expense
was $3.6 million and $11.3 million for the three and nine months
ended September 30, 2018, as compared to $6.8 million and $17.9
million for the same periods in 2017, primarily relating to the
vecabrutinib and the vosaroxin development program in each period.
The decreases of $3.2 million and $6.6 million between the
comparable periods from last year was primarily due to a $2.5
million milestone payment made during the third quarter of 2017 to
Biogen under the license agreement, a decrease in salary and
personnel expenses, a decrease in professional services, and
clinical trial expenses related to higher expenses incurred in 2017
due to the MAA with the EMA.
- General and administrative expense
was $2.7 million and $8.9 million for the three and nine months
ended September 30, 2018, as compared to $3.2 million and $10.8
million for the same periods in 2017. The decreases of $0.5 million
and $1.9 million between the comparable periods in 2017 were
primarily due to reduced professional services, personnel, and
commercial expenses.
- Interest expense was $0.3 million
and $0.9 million for the three and nine months ended September 30,
2018, as compared to $0.3 million and $1.1 million for the same
periods in 2017. The decrease during the nine months period was
primarily due to the decrease in the outstanding notes
payable.
- Cash used in operating activities
was $17.9 million for the nine months ended September 30, 2018, as
compared to $30.8 million for the same period in 2017. Net cash
used in the 2018 periods resulted primarily from the net loss of
$20.6 million, partly offset by net adjustments for non-cash items
of $2.3 million and changes in operating assets and liabilities of
$0.4 million. 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, partly offset by net adjustments
for non-cash items of $2.6 million.
- Loss from operations was $6.3
million and $20.0 million for the three and nine months ended
September 30, 2018, as compared to $9.9 million and $28.0 million
for the same periods in 2017. Net loss was $6.5 million and
$20.6 million for the three and nine months ended September 30,
2018, as compared to $10.2 million and $28.8 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 5971729. 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 its oral non-covalent BTK
inhibitor vecabrutinib. Vecabrutinib is currently being evaluated
in a Phase 1b/2 study in adults with chronic lymphocytic leukemia
and other B-cell malignancies that have progressed after prior
therapies. The Company’s proprietary PDK1 inhibitor SNS-510 is in
preclinical development. 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 plans to
submit an IND for SNS-510 in 2019. Sunesis is exploring strategic
alternatives for vosaroxin, a late-stage investigational product
for relapsed or refractory AML. Sunesis also has an interest in the
pan-RAF inhibitor TAK-580 which is licensed to Takeda. TAK-580 is
in a clinical trial for pediatric low-grade glioma.
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 and TAK-580. Words such as “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 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 September 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. |
|
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
|
AND COMPREHENSIVE
LOSS |
|
(In thousands, except per
share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
endedSeptember 30, |
|
|
Nine months
endedSeptember 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and other revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
237 |
|
|
$ |
669 |
|
Total revenues |
|
|
- |
|
|
|
- |
|
|
|
237 |
|
|
|
669 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,587 |
|
|
|
6,763 |
|
|
|
11,314 |
|
|
|
17,866 |
|
General and administrative |
|
|
2,690 |
|
|
|
3,175 |
|
|
|
8,873 |
|
|
|
10,788 |
|
Total operating expenses |
|
|
6,277 |
|
|
|
9,938 |
|
|
|
20,187 |
|
|
|
28,654 |
|
Loss from operations |
|
|
(6,277 |
) |
|
|
(9,938 |
) |
|
|
(19,950 |
) |
|
|
(27,985 |
) |
Interest expense |
|
|
(291 |
) |
|
|
(288 |
) |
|
|
(859 |
) |
|
|
(1,116 |
) |
Other income, net |
|
|
63 |
|
|
|
67 |
|
|
|
191 |
|
|
|
266 |
|
Net loss |
|
|
(6,505 |
) |
|
|
(10,159 |
) |
|
|
(20,618 |
) |
|
|
(28,835 |
) |
Unrealized gain on available-for-sale securities |
|
|
1 |
|
|
|
8 |
|
|
|
7 |
|
|
|
21 |
|
Comprehensive loss |
|
$ |
(6,504 |
) |
|
$ |
(10,151 |
) |
|
$ |
(20,611 |
) |
|
$ |
(28,814 |
) |
Basic and diluted loss per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,505 |
) |
|
$ |
(10,159 |
) |
|
$ |
(20,618 |
) |
|
$ |
(28,835 |
) |
Shares used in computing basic and diluted
loss per common share |
|
|
36,095 |
|
|
|
23,678 |
|
|
|
34,956 |
|
|
|
22,106 |
|
Basic and diluted loss per common share |
|
$ |
(0.18 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.59 |
) |
|
$ |
(1.30 |
) |
SUNESIS PHARMACEUTICALS,
INC. |
|
CONDENSED CONSOLIDATED
BALANCE SHEETS |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
September
30, |
|
|
December
31, |
|
|
|
2018 |
|
|
2017 |
|
|
|
(Unaudited) |
|
|
(1) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
20,162 |
|
|
$ |
26,977 |
|
Marketable securities |
|
|
- |
|
|
|
4,773 |
|
Prepaids and other current assets |
|
|
1,302 |
|
|
|
1,183 |
|
Total current assets |
|
|
21,464 |
|
|
|
32,933 |
|
Property and equipment, net |
|
|
14 |
|
|
|
20 |
|
Deposits and other assets |
|
|
108 |
|
|
|
1,381 |
|
Total assets |
|
$ |
21,586 |
|
|
$ |
34,334 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,277 |
|
|
$ |
1,697 |
|
Accrued clinical expense |
|
|
644 |
|
|
|
767 |
|
Accrued compensation |
|
|
1,186 |
|
|
|
1,440 |
|
Other accrued liabilities |
|
|
1,831 |
|
|
|
1,570 |
|
Notes payable |
|
|
7,348 |
|
|
|
7,204 |
|
Total current liabilities |
|
|
12,286 |
|
|
|
12,678 |
|
Other liabilities |
|
|
4 |
|
|
|
112 |
|
Total liabilities |
|
|
12,290 |
|
|
|
12,790 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock |
|
|
20,966 |
|
|
|
20,966 |
|
Common stock |
|
|
4 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
641,798 |
|
|
|
633,436 |
|
Accumulated other comprehensive loss |
|
|
- |
|
|
|
(7 |
) |
Accumulated deficit |
|
|
(653,472 |
) |
|
|
(632,854 |
) |
Total stockholders’ equity |
|
|
9,296 |
|
|
|
21,544 |
|
Total liabilities and stockholders’ equity |
|
$ |
21,586 |
|
|
$ |
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. |
|
Investor and Media Inquiries:Maeve ConneightonArgot
Partners212-600-1902 |
Willie QuinnSunesis Pharmaceuticals Inc.650-266-3716 |
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