Sunesis Pharmaceuticals Reports Second Quarter 2019 Financial Results and Recent Highlights
August 07 2019 - 3:05PM
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported
financial results for the quarter ended June 30, 2019. Loss from
operations for the three and six months ended June 30, 2019 was
$6.2 million and $11.9 million. As of June 30, 2019, cash and cash
equivalents, restricted cash, and marketable securities totaled
$17.7 million. Subsequent to the end of the quarter, the Company
raised approximately $25.9 million in net proceeds from an
underwritten offering.
“We continue to make progress in the Phase 1b/2
trial of our non-covalent BTK inhibitor vecabrutinib in chronic
lymphocytic leukemia and other B-cell malignancies. At the annual
European Hematology Association meeting in June, we presented
preliminary data demonstrating vecabrutinib’s well-tolerated safety
profile and evidence of clinical activity,” said Dayton Misfeldt,
Interim Chief Executive Officer of Sunesis. “More recently, in
July, we announced completion of the safety evaluation period for
the 200mg cohort, which continues to support the favorable safety
profile with no drug-related serious adverse events experienced to
date. We look forward to further defining the profile of
vecabrutinib in the current study as we prepare for the upcoming
Phase 2. We plan on sharing the next clinical update on the study
at the annual American Society of Hematology meeting later this
year.”
“In addition, we strengthened our balance sheet
by completing an equity offering in July with leading biotechnology
investors, as well as refinancing our previous loan with a new
facility from Silicon Valley Bank in April. The proceeds from our
recent offering extends our cash runway through key milestones
including the initiation of the Phase 2 portion of the trial.”
Recent Highlights
- Advanced Phase 1b/2 Trial
of Vecabrutinib into 300 mg Cohort. In July 2019, Sunesis
opened enrollment in the 300 mg cohort in the Phase 1b/2 trial of
its non-covalent BTK inhibitor vecabrutinib in adults with
relapsed/refractory chronic lymphocytic leukemia (CLL) and
other B-cell malignancies.
- Presented Preliminary Data
at the EHA Annual Meeting. In June 2019, Sunesis presented
preliminary data from the ongoing vecabrutinib clinical trial at
the 24th Congress of the European Hematology Association in
Amsterdam. The promising data builds upon vecabrutinib’s safety,
activity, pharmacokinetic, and pharmacodynamic profile.
- Completion of Public
Offering. In July 2019, Sunesis completed underwritten
public offerings of shares of its common stock and Series F
convertible preferred stock with net proceeds of approximately
$25.9 million. The offerings attracted participation from leading
biotechnology investors and will allow Sunesis to advance
vecabrutinib through important clinical milestones as the ongoing
dose-escalation study explores potentially active dose levels.
- Secured $5.5 Million
Loan. In April 2019, the Company entered into a $5.5
million loan agreement with Silicon Valley Bank (SVB), allowing the
Company to retire its existing loan. The new agreement allows the
Company to defer any principal repayment on the new loan for more
than 18 months, with interest-only payments through 2020 and
principal repayment over 24 months beginning in 2021. The new loan
also has a lower interest rate, and was used to repay the Company’s
prior loan.
- Announced Executive
Promotions. In July 2019, Sunesis promoted Judy Fox, Ph.D.
to Chief Scientific Officer, Executive Vice President, Research
& Development, and Parvinder (Par) S. Hyare to Senior Vice
President, Commercial. We look forward to their leadership as we
prepare for the next stage of the Company’s growth.
Financial Highlights
- Cash and cash equivalents,
restricted cash, and marketable securities totaled $17.7 million as
of June 30, 2019, as compared to $13.7 million as of December 31,
2018. This capital, plus the approximately $25.9 million in net
proceeds from the July 2019 public offerings, is expected to fund
the Company through the initiation of the Phase 2 portion of the
ongoing vecabrutinib Phase 1b/2 trial. The increase of $4.0 million
was primarily due to $19.0 million net proceeds from issuance of
common and preferred stock, and $5.5 million proceeds from SVB Loan
Agreement, offset by $13.0 million net cash used in operating
activities and $7.5 million used in principal payments to repay the
Company’s prior loan.
- Research and development expense
was $3.7 million and $6.9 million for the three and six months
ended June 30, 2019, as compared to $3.8 million and $7.7 million
for the same periods in 2018. The decreases between the comparable
periods were primarily due to a decrease in salary and personnel
expenses due to lower headcount, decrease in professional services
related to higher expenses incurred in the first half of 2018 for
the start-up costs of the Phase 1b/2 trial for vecabrutinib, offset
by an increase in clinical expenses related to the preparation for
the Phase 2 portion of the ongoing clinical trial of
vecabrutinib.
- General and administrative expense
was $2.5 million and $5.0 million for the three and six months
ended June 30, 2019, as compared to $2.8 million and $6.2 million
for the same periods in 2018. The decreases between the comparable
periods were primarily due to a decrease in salary and personnel
expenses due to lower headcount and stock-based compensation and a
decrease in professional services expenses due to lower legal and
vosaroxin patent expenses.
- Interest expense was $0.1 million
and $0.4 million for the three and six months ended June 30, 2019,
as compared to $0.3 million and $0.6 million for the same periods
in 2018. The decreases in interest expense from both periods
resulted from a lower interest rate on a lower principal amount
under the SVB Loan Agreement.
- Cash used in operating activities
was $13.0 million for the six months ended June 30, 2019, as
compared to $12.4 million for the same period in 2018. Net cash
used in the six months ended June 30, 2019, resulted primarily from
the net loss of $12.1 million, partially offset by adjustments for
non-cash items of $0.9 million and changes in operating assets and
liabilities of $1.8 million. Net cash used in the six months ended
June 30, 2018, resulted primarily from the net loss of $14.1
million, partially offset by adjustments for non-cash items of $1.6
million and changes in operating assets and liabilities of $0.1
million.
- Sunesis reported loss from
operations of $6.2 million and $11.9 million for the three and six
months ended June 30, 2019, as compared to $6.6 million and $13.7
million for the same periods in 2018. Net loss was $6.2
million and $12.1 million for the three and six months ended June
30, 2019, as compared to $6.8 million and $14.1 million for the
same periods in 2018.
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 2686126. 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, 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.
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 the expectations
regarding the completion, timing and use of proceeds of Sunesis’
proposed offerings. Words such as "may," “intend,” “will,”
“potential,” 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, risks
related to market conditions and the satisfaction of customary
closing conditions related to the proposed offerings. These and
other risk factors are discussed under "Risk Factors" in the
applicable prospectus supplement and in Sunesis' Quarterly Report
on Form 10-Q for the quarter ended June 30, 2019 and Sunesis' other
filings with the Securities and Exchange Commission. There can be
no assurance that Sunesis will be able to complete the proposed
offerings on the anticipated terms, or at all. 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. |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
AND COMPREHENSIVE LOSS |
|
(In thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months endedJune
30, |
|
|
Six months endedJune
30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and other revenue |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
237 |
|
Total revenues |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
237 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,683 |
|
|
|
3,758 |
|
|
|
6,931 |
|
|
|
7,727 |
|
General and administrative |
|
|
2,523 |
|
|
|
2,824 |
|
|
|
4,962 |
|
|
|
6,183 |
|
Total operating expenses |
|
|
6,206 |
|
|
|
6,582 |
|
|
|
11,893 |
|
|
|
13,910 |
|
Loss from operations |
|
|
(6,206 |
) |
|
|
(6,582 |
) |
|
|
(11,893 |
) |
|
|
(13,673 |
) |
Interest expense |
|
|
(111 |
) |
|
|
(287 |
) |
|
|
(372 |
) |
|
|
(568 |
) |
Other income, net |
|
|
76 |
|
|
|
29 |
|
|
|
164 |
|
|
|
128 |
|
Net loss |
|
|
(6,241 |
) |
|
|
(6,840 |
) |
|
|
(12,101 |
) |
|
|
(14,113 |
) |
Unrealized gain on available-for-sale securities |
|
|
— |
|
|
|
4 |
|
|
|
— |
|
|
|
6 |
|
Comprehensive loss |
|
$ |
(6,241 |
) |
|
$ |
(6,836 |
) |
|
$ |
(12,101 |
) |
|
$ |
(14,107 |
) |
Basic and diluted loss per
common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,241 |
) |
|
$ |
(6,840 |
) |
|
$ |
(12,101 |
) |
|
$ |
(14,113 |
) |
Shares used in computing basic and diluted loss per common
share |
|
|
72,190 |
|
|
|
34,417 |
|
|
|
65,702 |
|
|
|
34,381 |
|
Basic and diluted loss per
common share |
|
$ |
(0.09 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.41 |
) |
|
|
SUNESIS PHARMACEUTICALS, INC. |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30 |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
(Unaudited) |
|
|
(Note 1) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,797 |
|
|
$ |
13,696 |
|
Restricted cash |
|
|
5,500 |
|
|
|
— |
|
Marketable securities |
|
|
2,386 |
|
|
|
— |
|
Prepaids and other current assets |
|
|
2,159 |
|
|
|
1,504 |
|
Total current assets |
|
|
19,842 |
|
|
|
15,200 |
|
Property and equipment, net |
|
|
7 |
|
|
|
11 |
|
Operating lease right-of-use asset |
|
|
1,090 |
|
|
|
— |
|
Other assets |
|
|
105 |
|
|
|
113 |
|
Total assets |
|
$ |
21,044 |
|
|
$ |
15,324 |
|
LIABILITIES AND
STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
692 |
|
|
$ |
1,393 |
|
Accrued clinical expense |
|
|
525 |
|
|
|
500 |
|
Accrued compensation |
|
|
869 |
|
|
|
943 |
|
Other accrued liabilities |
|
|
656 |
|
|
|
1,091 |
|
Notes payable |
|
|
5,456 |
|
|
|
7,396 |
|
Operating lease liability - current |
|
|
545 |
|
|
|
— |
|
Total current liabilities |
|
|
8,743 |
|
|
|
11,323 |
|
Other liabilities |
|
|
17 |
|
|
|
8 |
|
Operating lease liability - long term |
|
|
545 |
|
|
|
— |
|
Total liabilities |
|
|
9,305 |
|
|
|
11,331 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Convertible preferred stock |
|
|
7,113 |
|
|
|
20,998 |
|
Common stock |
|
|
7 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
676,189 |
|
|
|
642,460 |
|
Accumulated deficit |
|
|
(671,570 |
) |
|
|
(659,469 |
) |
Total stockholders’
equity |
|
|
11,739 |
|
|
|
3,993 |
|
Total liabilities and
stockholders’ equity |
|
$ |
21,044 |
|
|
$ |
15,324 |
|
|
|
|
|
|
|
|
|
|
Note 1: 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. |
|
|
|
Investor and Media Inquiries:Maeve ConneightonArgot
Partners212-600-1902
Willie QuinnSunesis Pharmaceuticals, Inc.650-266-3716
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