Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2019 Financial Results and Recent Highlights
“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
Vecabrutinib Phase 1b/2 Clinical Update. Since the presentation of clinical data through cohort 5 at ASH in
- 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
- 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 millionof proceeds from the SVB loan, partially offset by $22.2 millionnet cash used in operating activities and a $7.5 millionprincipal repayment of the prior loan from Western Alliance Bankand 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 millionin 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 millionin 2019 compared to $14.6 millionin 2018, primarily relating to the vecabrutinib development program. The increase of $0.8 millionin 2019 was primarily due to a $1.8 millionincrease 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 milliondecrease 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 milliondecrease in salary and personnel expenses due in large part to lower stock-based compensation and a $0.8 milliondecrease 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 millionincrease 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 millionin 2019, compared to $24.4 millionin 2018. Cash used in the 2019 period resulted primarily from the net loss of $23.3 millionand 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 (
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.
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:|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended
||Twelve months ended
|License and other revenue||$||2,073||$||-||$||2,073||$||237|
|Research and development||4,947||3,301||15,412||14,615|
|General and administrative||2,480||2,459||9,949||11,332|
|Total operating expenses||7,427||5,760||25,361||25,947|
|Loss from operations||(5,354||)||(5,760||)||(23,288||)||(25,710||)|
|Other income, net||138||58||472||249|
|Unrealized gain on available-for-sale securities||1||-||1||7|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share||111,343||37,438||87,129||35,582|
|Basic and diluted loss per common share||$||(0.05||)||$||(0.16||)||$||(0.27||)||$||(0.75||)|
|Note 1: The consolidated statement of operations and comprehensive loss for the year ended
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||12,761||$||13,696|
|Prepaids and other current assets||1,697||1,504|
|Total current assets||36,322||15,200|
|Property and equipment, net||3||11|
|Operating lease right-of-use asset||817||-|
|Deposits and other assets||98||113|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||521||500|
|Other accrued liabilities||1,109||1,091|
|Operating lease liability - current||545||-|
|Total current liabilities||9,416||11,323|
|Operating lease liability - long term||272||-|
|Convertible preferred stock||11,769||20,998|
|Additional paid-in capital||698,562||642,460|
|Accumulated other comprehensive income||1||-|
|Total stockholders’ equity||27,543||3,993|
|Total liabilities and stockholders’ equity||$||37,240||$||15,324|
|Note 2: The consolidated balance sheet as of
Source: Sunesis Pharmaceuticals, Inc.