Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2019 Financial Results and Recent Highlights
11 March 2020 - 7:05AM
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported
financial results for the fourth quarter and year
ended December 31, 2019. Loss from operations for the three
months and year ended December 31, 2019 was $5.4
million and $23.3 million. As of December 31, 2019, cash
and cash equivalents, restricted cash, and marketable securities
totaled $34.6 million.
“We concluded 2019 having made solid progress across our
portfolio. Vecabrutinib, our non-covalent BTK inhibitor,
demonstrated a very favorable safety profile combined with evidence
of clinical activity in patients with and without BTK
C481-mutations. We continue to advance and characterize our
proprietary PDK1 inhibitor, SNS-510, with findings supporting
development in both hematologic and solid tumors. We are also
building value in our product pipeline through partnerships. In
December, we partnered vosaroxin with Denovo Biopharma and TAK-580
with DOT Therapeutics-1 to advance these programs to the market,”
said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis.
“Looking ahead, we remain on track to complete the Phase 1b dose
escalation component of our Phase 1b/2 vecabrutinib trial in the
second quarter and to advance SNS-510 to an IND by the end of
year.”
Vecabrutinib Phase 1b/2 Clinical Update. Since
the presentation of clinical data through cohort 5 at ASH in
December 2019, Sunesis has enrolled patients in cohorts 6 and 7 of
the ongoing Phase 1b/2 trial of vecabrutinib.
- Cohort 5 (300mg): Sunesis announced at ASH 2019 that stable
disease was observed in three of five patients from cohort 5 (300mg
BID). As of today, one chronic lymphocytic leukemia (CLL) patient
remains on study in cycle 8 at 300mg BID with a 47% reduction in
tumor burden at their second scan, improving from their initial 41%
reduction, with normalized hematology parameters.
- Cohort 6 (400mg BID): Four patients, three CLL and one diffuse
large B cell lymphoma (DLBCL), were enrolled in the cohort. The
DLBCL patient was nonevaluable due to disease progression during
cycle one. The three CLL patients completed the safety evaluation
period, remain on treatment, and results of their first response
assessments will be available later this month.
- Cohort 7 (500mg BID): Six patients, four with CLL and two with
mantle cell lymphoma (MCL), cleared the safety evaluation period
and four of the patients remain on treatment. We expect first
response assessments for these patients in the second quarter.
Additional patients are being evaluated for the cohort.
- Vecabrutinib has been very well tolerated, with no Grade 3 or
higher drug-related adverse events reported to date across cohorts
3 – 7.
SNS-510, first-in-class PDK1
inhibitor. In October, at the 2019 AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer
Therapeutics, Sunesis presented data profiling the oral PDK1
inhibitor SNS-510 showing potent activity in hematologic and
solid tumor cancer models. New results of in vitro combination
studies indicate that SNS-510 can combine synergistically with
several drugs including inhibitors of CDK4/6, KRAS G12C, and BCL2.
The IND-enabling program is progressing as planned and an IND
filing is targeted for the end of
2020. Partnering
TAK-580 and vosaroxin. In December, Sunesis
consented to Takeda Oncology’s assignment of our agreement relating
to the pan-Raf inhibitor TAK-580 to DOT Therapeutics-1, Inc.
(“DOT-1”). Coincident with the transaction, Sunesis and DOT-1
entered into a new agreement covering TAK-580 and DOT-1 paid
Sunesis an upfront fee of $2.0 million. Under the new TAK-580
agreement, DOT-1 agreed to pay Sunesis up to $57.0 million in
pre-commercialization milestone payments, plus royalties on future
sales of TAK-580. Also in December, Sunesis licensed vosaroxin to
Denovo Biopharma LLC (“Denovo”). Sunesis received a $0.2 million
upfront payment and is eligible to receive up to $57.0 million in
regulatory and commercial milestones, plus double-digit royalties
on future sales of vosaroxin.
Financial Highlights
- Cash and cash equivalents, restricted cash and marketable
securities totaled $34.6 million as of December 31,
2019, compared to $13.7 million as of December 31, 2018.
The increase of $20.9 million was primarily due
to $45.1 million of net proceeds from the issuance of common
and preferred stock, and $5.5 million of proceeds from the SVB
loan, partially offset by $22.2 million net cash used in operating
activities and a $7.5 million principal repayment of the prior loan
from Western Alliance Bank and Solar Capital Ltd.
- Revenue was $2.1 million in 2019 compared
to $0.2 million in 2018. Revenue in both periods was
derived from license agreements. The increase of $2.0 million in
2019 was primarily due to revenue recognized from the upfront
payments received under the license agreements with DOT-1 and
Denovo.
- Research and development expense was $15.4 million in 2019
compared to $14.6 million in 2018, primarily relating to the
vecabrutinib development program. The increase of $0.8 million in
2019 was primarily due to a $1.8 million increase in professional
services and clinical expenses related to the preparation for the
Phase 2 portion of our ongoing clinical trial for vecabrutinib,
offset by a $1.0 million decrease in salary and personnel
expenses.
- General and administrative expense was $9.9 million in
2019 compared to $11.3 million in 2018. The decrease of
$1.4 million in 2019 was primarily due to a $1.1 million
decrease in salary and personnel expenses due in large part to
lower stock-based compensation and a $0.8 million decrease in
professional services expenses due to lower legal and vosaroxin
patent expenses. The decreases in the comparable periods were
partially offset by a $0.3 million increase in insurance premiums.
- Interest expense was $0.5 million in 2019 compared to
$1.2 million in 2018. The decrease in 2019 was primarily due
to lower interest paid under the SVB Loan Agreement compared to the
prior loan.
- Cash used in operating activities was $22.2 million in 2019,
compared to $24.4 million in 2018. Cash used in the 2019 period
resulted primarily from the net loss of $23.3 million and changes
in operating assets and liabilities of $0.7 million, offset by net
adjustments for non-cash items of $1.8 million.
- Loss from operations was $5.4
million and $23.3 for the three months and year
ended December 31, 2019, compared to $5.8 million
and $25.7 million for the same periods in 2018. Net
loss was $5.3 million and $23.3 million for the
three months and year ended December 31, 2019, compared to
$6.0 million and $26.6 million for the same periods
in 2018.
Conference Call Information
Sunesis will host a conference call 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 2388763. 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 novel targeted inhibitors 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, including its oral non-covalent BTK
inhibitor vecabrutinib and first-in-class PDK1 inhibitor SNS-510.
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.
For additional information on Sunesis, please
visit www.sunesis.com.
SUNESIS and the logos are trademarks
of Sunesis Pharmaceuticals, Inc.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements related to Sunesis’ continued
development of vecabrutinib, including the timing and results of
the Phase 1b/2 trial of vecabrutinib and the therapeutic potential
of vecabrutinib, further development and potential of its kinase
inhibitor pipeline, including the timing of the potential IND
filing for SNS-510, its ability to receive potential milestone or
royalty payments under license and collaboration agreements and the
timing of receipt of those payments, and sufficiency of its cash
resources and financial position. Words such as “expect,” “will,”
“look forward,” 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. These and other risk factors are discussed
under "Risk Factors" in Sunesis' Annual Report on Form 10-K for the
year ended December 31, 2019 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.
Investor and Media
Inquiries: |
Maeve Conneighton Argot Partners 212-600-1902 |
Willie Quinn Sunesis Pharmaceuticals Inc. 650-266-3716 |
|
SUNESIS PHARMACEUTICALS, INC. |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
AND COMPREHENSIVE LOSS |
|
(In thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
Three months ended December 31, |
|
Twelve months ended December 31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
|
(1) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and other revenue |
$ |
2,073 |
|
|
$ |
- |
|
|
$ |
2,073 |
|
|
$ |
237 |
|
Total revenues |
|
2,073 |
|
|
|
- |
|
|
|
2,073 |
|
|
|
237 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
4,947 |
|
|
|
3,301 |
|
|
|
15,412 |
|
|
|
14,615 |
|
|
General and administrative |
|
2,480 |
|
|
|
2,459 |
|
|
|
9,949 |
|
|
|
11,332 |
|
Total operating expenses |
|
7,427 |
|
|
|
5,760 |
|
|
|
25,361 |
|
|
|
25,947 |
|
Loss from operations |
|
(5,354 |
) |
|
|
(5,760 |
) |
|
|
(23,288 |
) |
|
|
(25,710 |
) |
Interest expense |
|
(71 |
) |
|
|
(295 |
) |
|
|
(514 |
) |
|
|
(1,154 |
) |
|
Other income, net |
|
138 |
|
|
|
58 |
|
|
|
472 |
|
|
|
249 |
|
Net loss |
|
(5,287 |
) |
|
|
(5,997 |
) |
|
|
(23,330 |
) |
|
|
(26,615 |
) |
|
Unrealized gain on
available-for-sale securities |
|
1 |
|
|
|
- |
|
|
|
1 |
|
|
|
7 |
|
Comprehensive loss |
$ |
(5,286 |
) |
|
$ |
(5,997 |
) |
|
$ |
(23,329 |
) |
|
$ |
(26,608 |
) |
Basic and diluted loss per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(5,287 |
) |
|
$ |
(5,997 |
) |
|
$ |
(23,330 |
) |
|
$ |
(26,615 |
) |
|
Shares used in computing basic and diluted loss per common
share |
|
111,343 |
|
|
|
37,438 |
|
|
|
87,129 |
|
|
|
35,582 |
|
Basic and diluted loss per common share |
$ |
(0.05 |
) |
|
$ |
(0.16 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.75 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1: The consolidated statement of operations and comprehensive
loss for the year ended December 31, 2018 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, 2018. |
|
|
|
|
|
|
|
|
|
SUNESIS PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In thousands) |
|
|
|
|
|
December 31, |
December 31, |
|
|
2019 |
|
|
|
2018 |
|
|
(Unaudited) |
|
|
(2) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
12,761 |
|
|
$ |
13,696 |
|
Restricted cash |
|
5,500 |
|
|
|
- |
|
Marketable securities |
|
16,364 |
|
|
|
- |
|
Prepaids and other current assets |
|
1,697 |
|
|
|
1,504 |
|
Total current assets |
|
36,322 |
|
|
|
15,200 |
|
Property and equipment, net |
|
3 |
|
|
|
11 |
|
Operating lease right-of-use asset |
|
817 |
|
|
|
- |
|
Deposits and other assets |
|
98 |
|
|
|
113 |
|
Total assets |
$ |
37,240 |
|
|
$ |
15,324 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
791 |
|
|
$ |
1,393 |
|
Accrued clinical expense |
|
521 |
|
|
|
500 |
|
Accrued compensation |
|
985 |
|
|
|
943 |
|
Other accrued liabilities |
|
1,109 |
|
|
|
1,091 |
|
Notes payable |
|
5,465 |
|
|
|
7,396 |
|
Operating lease liability - current |
|
545 |
|
|
|
- |
|
Total current liabilities |
|
9,416 |
|
|
|
11,323 |
|
Other liabilities |
|
9 |
|
|
|
8 |
|
Operating lease liability - long term |
|
272 |
|
|
|
- |
|
Total liabilities |
|
9,697 |
|
|
|
11,331 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Convertible preferred stock |
|
11,769 |
|
|
|
20,998 |
|
Common stock |
|
11 |
|
|
|
4 |
|
Additional paid-in capital |
|
698,562 |
|
|
|
642,460 |
|
Accumulated other comprehensive income |
|
1 |
|
|
|
- |
|
Accumulated deficit |
|
(682,800 |
) |
|
|
(659,469 |
) |
Total stockholders’ equity |
|
27,543 |
|
|
|
3,993 |
|
Total liabilities and stockholders’ equity |
$ |
37,240 |
|
|
$ |
15,324 |
|
|
|
|
|
|
|
|
|
Note 2: The consolidated balance sheet as of December 31, 2018 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, 2018. |
|
|
|
|
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