Sunesis Pharmaceuticals Reports Third Quarter 2019 Financial Results and Recent Highlights
November 12 2019 - 3:05PM
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported
financial results for the quarter ended September 30, 2019.
Loss from operations for the three and nine months
ended September 30, 2019 was $6.0
million and $17.9 million. As of September 30, 2019,
the Company had cash and cash equivalents, restricted cash and
marketable securities of $38.3 million.
“We continue to advance our Phase 1b/2 trial of
vecabrutinib in patients with B-cell malignancies with the goal of
identifying our recommended dose and studying vecabrutinib in
defined patient populations in the Phase 2 portion of the study. We
are currently in the 400mg cohort as the safety and pharmacokinetic
data to date support continued dose escalation,” said Dayton
Misfeldt, Interim Chief Executive Officer of Sunesis. “As announced
last week, we will be presenting a poster at the ASH Annual Meeting
in December that provides an update on the Phase 1b/2 trial of
vecabrutinib, and we look forward to sharing the new findings. We
also recently presented exciting preclinical pharmacology data for
our first-in-class PDK1 inhibitor, SNS-510, at the AACR-NCI-EORTC
conference. The equity offering we completed in July
strengthened our cash position and extends our runway through key
milestones for the Company.”
Recent Highlights
- Announced Presentation at ASH Annual Meeting.
In November 2019, the Company announced that a presentation will be
made at the 61st American Society of Hematology (ASH) Annual
Meeting to be held December 7-10, 2019 in Orlando, Florida. The
abstract, titled “Ongoing Results of a Phase 1B/2 Dose-Escalation
and Cohort-Expansion Study of the Selective, Noncovalent,
Reversible Burton’s Tyrosine Kinase Inhibitor, Vecabrutinib, in
B-Cell Malignancies” (Publication 3041), will be presented on
Sunday, December 8, in a session titled “CLL: Therapy, excluding
Transplantation: Poster II,” from 6:00-8:00pm ET at the Orange
County Convention Center, Hall B. The poster will be available on
the Sunesis website following the presentation.
- Presented Preclinical Data on SNS-510 at the 2019
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics. In October 2019, Sunesis
presented data profiling the oral PDK1 inhibitor SNS-510 showing
potent activity in hematologic and solid tumor cancer models at the
2019 AACR-NCI-EORTC International Conference on Molecular Targets
and Cancer Therapeutics in Boston, Massachusetts.
- Hired Mehdi Paborji, PhD as VP Technical Operations;
promoted Pietro Taverna, PhD to VP Translational Medicine &
Nonclinical Development. Dr. Paborji has over 30 years of
experience in the industry, including fifteen years at
Bristol-Myers Squibb. More recently he served as Chief Operating
Officer of Biotie Therapeutics through its sale to Acorda
Therapeutics and was also the Founder and COO of Theravida. He has
experience leading technical and clinical supply operations, and
all aspects of manufacturing of drug substance and drug product.
Dr. Paborji has a PhD. in Physical Organic and Bio-Organic
Chemistry from the University of Kansas and postdoctoral training
in Pharmaceutical Chemistry from the University of Kansas, the
School of Pharmacy. Dr. Taverna has over 18 years of experience in
the biopharmaceutical industry, exclusively in oncology
pharmacology and translational medicine. He returned to Sunesis in
2017 as head of Translational Medicine after nine years at Astex
(Otsuka) Pharmaceuticals leading translational medicine programs
for their oncology portfolio. Prior to Astex, Dr. Taverna held
senior/principal scientist positions at Sunesis and Chiron,
overseeing and conducting pharmacology efforts for cancer drug
candidates. He has numerous publications as well as presentations
at international oncology meetings. Dr. Taverna has a Ph.D. in
Pharmacological Research from M. Negri Institute for
Pharmacological Research, Milano, Italy and did postdoctoral
research at the Institute and at Case Western
University.
- Appointed Dr. Nicole Onetto to the Board of
Directors. In September 2019, Sunesis appointed
Dr. Nicole Onetto, M.D. to the Board of Directors, bringing to
Sunesis 20 years of clinical development experience in oncology and
hematology.
- 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 $26.1 million. The offerings
attracted participation from leading biotechnology investors,
including existing and new investors.
Financial Highlights
- Cash and cash equivalents, restricted cash, and marketable
securities totaled $38.3 million as of September 30,
2019, compared to $13.7 million as of December 31, 2018. The
increase of $24.6 million was primarily due to $45.1 million in net
proceeds from issuance common and preferred stock, and $5.5 million
in proceeds from the Silicon Valley Bank Loan Agreement, partially
offset by $18.4 million in net cash used in operating activities
and $7.5 million principal payment on the Bridge Bank / Solar
Capital Loan Agreement and Amendments. This capital is expected to
fund the Company through the identification of the Phase 2 dose and
initiation of the Phase 2 portion of the ongoing
trial.
- Research and development expense was $3.5
million and $10.5 million for the three and nine
months ended September 30, 2019, compared to $3.6
million and $11.3 million for the same periods in
2018. The decreases between the comparable three and nine month
periods were primarily due to a decrease in salary and personnel
expenses due to lower headcount and a decrease in clinical expense
due to timing, offset by an increase in professional services
related to the preparation for the Phase 2 portion of the ongoing
clinical trial for vecabrutinib.
- General and administrative expense was $2.5
million and $7.5 million for the three and nine
months ended September 30, 2019, compared to $2.7
million and $8.9 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, offset by an increase in insurance
premiums.
- Interest expense was $0.1 million and $0.4
million for the three and nine months ended September 30,
2019, compared to $0.3 million and $0.9
million for the same periods in 2018. The decreases in
interest expenses from both periods resulted from the lower
interest rate paid on a lower principal amount under the SVB Loan
Agreement.
- Cash used in operating activities was $18.4
million for the nine months ended September 30, 2019,
compared to $17.9 million for the same period in 2018.
Net cash used in the nine months ended September 30, 2019 resulted
primarily from the net loss of $18.0 million and changes in
operating assets and liabilities of $1.8 million, offset by
adjustments for non-cash items of $1.4 million. Net cash used in
2018 period resulted primarily from the net loss of $20.6 million,
partially offset by adjustments for non-cash items of $2.3 million
and changes in operating assets and liabilities of $0.4
million.
- Sunesis reported loss from operations of $6.0
million and $17.9 million for the three and nine
months ended September 30, 2019, compared to $6.3
million and $20.0 million for the same periods in
2018. Net loss was $5.9 million and $18.0
million for the three and nine months ended September 30,
2019, compared to $6.5 million and $20.6
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 4059849. 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 Sunesis’ continued
development of vecabrutinib, 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 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' Quarterly Report on Form 10-Q for the
quarter ended September 30, 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.
|
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, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
Revenue: |
|
|
|
|
|
|
|
|
|
License and
other revenue |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
237 |
|
|
Total revenues |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
237 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
|
3,534 |
|
|
|
3,587 |
|
|
|
10,465 |
|
|
|
11,314 |
|
|
|
General and
administrative |
|
2,507 |
|
|
|
2,690 |
|
|
|
7,469 |
|
|
|
8,873 |
|
|
Total operating expenses |
|
6,041 |
|
|
|
6,277 |
|
|
|
17,934 |
|
|
|
20,187 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
(6,041 |
) |
|
|
(6,277 |
) |
|
|
(17,934 |
) |
|
|
(19,950 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(71 |
) |
|
|
(291 |
) |
|
|
(443 |
) |
|
|
(859 |
) |
|
|
Other income, net |
|
170 |
|
|
|
63 |
|
|
|
334 |
|
|
|
191 |
|
|
Net loss |
|
(5,942 |
) |
|
|
(6,505 |
) |
|
|
(18,043 |
) |
|
|
(20,618 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on available-for-sale securities |
|
- |
|
|
|
1 |
|
|
|
- |
|
|
|
7 |
|
|
Comprehensive loss |
$ |
(5,942 |
) |
|
$ |
(6,504 |
) |
|
$ |
(18,043 |
) |
|
$ |
(20,611 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per common share: |
|
|
|
|
|
|
|
|
|
Net
loss |
$ |
(5,942 |
) |
|
$ |
(6,505 |
) |
|
$ |
(18,043 |
) |
|
$ |
(20,618 |
) |
|
|
Shares used
in computing basic and diluted loss per common share |
|
105,070 |
|
|
|
36,095 |
|
|
|
78,969 |
|
|
|
34,956 |
|
|
Basic and diluted loss per common share |
$ |
(0.06 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.59 |
) |
|
SUNESIS
PHARMACEUTICALS, INC. |
|
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
(In
thousands) |
|
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
2019 |
|
2018 |
|
|
(Unaudited) |
|
|
(1) |
|
|
ASSETS |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
$ |
19,733 |
|
|
$ |
13,696 |
|
|
Restricted cash |
|
5,500 |
|
|
|
- |
|
|
Marketable securities |
|
13,080 |
|
|
|
- |
|
|
Prepaids and other current assets |
|
2,236 |
|
|
|
1,504 |
|
|
Total
current assets |
|
40,549 |
|
|
|
15,200 |
|
|
Property and equipment, net |
|
5 |
|
|
|
11 |
|
|
Operating lease right-of-use asset |
|
954 |
|
|
|
- |
|
|
Deposits and other assets |
|
102 |
|
|
|
113 |
|
|
Total
assets |
$ |
41,610 |
|
|
$ |
15,324 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
$ |
770 |
|
|
$ |
1,393 |
|
|
Accrued clinical expense |
|
544 |
|
|
|
500 |
|
|
Accrued compensation |
|
1,177 |
|
|
|
943 |
|
|
Other accrued liabilities |
|
398 |
|
|
|
1,091 |
|
|
Notes payable |
|
5,460 |
|
|
|
7,396 |
|
|
Operating lease liability - current |
|
545 |
|
|
|
- |
|
|
Total
current liabilities |
|
8,894 |
|
|
|
11,323 |
|
|
Other liabilities |
|
13 |
|
|
|
8 |
|
|
Operating lease liability - long term |
|
409 |
|
|
|
- |
|
|
Total
liabilities |
|
9,316 |
|
|
|
11,331 |
|
|
Stockholders’ equity: |
|
|
|
|
Convertible preferred stock |
|
11,763 |
|
|
|
20,998 |
|
|
Common stock |
|
11 |
|
|
|
4 |
|
|
Additional paid-in capital |
|
698,032 |
|
|
|
642,460 |
|
|
Accumulated deficit |
|
(677,512 |
) |
|
|
(659,469 |
) |
|
Total
stockholders’ equity |
|
32,294 |
|
|
|
3,993 |
|
|
Total
liabilities and stockholders’ equity |
$ |
41,610 |
|
|
$ |
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 Conneighton Argot Partners
212-600-1902 |
Willie Quinn Sunesis Pharmaceuticals Inc. 650-266-3716 |
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