Sunesis Pharmaceuticals Reports First Quarter 2019 Financial Results and Recent Highlights
Phase 1b/2 Trial of Vecabrutinib Advances into 200 mg Cohort
Sunesis to Host Conference Call Today at
“We continue our focus on the execution of the Phase 1b/2 trial of vecabrutinib and are excited to announce that we have completed the safety evaluation period for the 100 mg cohort, enabling us to advance the trial into the 200 mg cohort,” said
Mr. Misfeldt continued, “Underscoring our clinical progress is a strengthened financial position. We began the first quarter by completing an equity offering with leading biotechnology investors, extending our cash runway through important clinical milestones, and just last month we announced the refinancing of our debt on favorable terms through an agreement with
- Advancement into 200 mg Cohort. The Company has opened the 200 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.
$5.5 MillionLoan with Silicon Valley Bank. In April 2019, the Company entered into a $5.5 millionloan agreement with Silicon Valley Bank. The new agreement allows the company to retire its existing loan and defer any principal repayment on the new loan for more than 18 months. The new facility includes interest-only payments through 2020, with principal repayment over 24 months beginning in 2021, as well as a lower interest rate than the previous loan. The loan was used for the repayment of the Company’s existing indebtedness.
- Completion of
$20 MillionFinancing. In January, Sunesis completed an equity financing with net proceeds of approximately $18.6 million. The financing 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.
- Cash and cash equivalents totaled
$24.8 millionas of March 31, 2019, as compared to $13.7 millionas of December 31, 2018. The increase of $11.1 millionwas primarily due to $18.6 millionnet proceeds from issuance of common and preferred stock, offset by $6.1 millionnet cash used in operating activities and $1.4 millionprincipal payment on the Loan Agreement with Western Alliance Bankand Solar Capital Ltd.
- Research and development expense was
$3.2 millionfor the three months ended March 31, 2019, as compared to $4.0 millionfor the same period in 2018. The decrease of $0.8 millionbetween the comparable three-month periods was primarily due to a $0.4 milliondecrease in salary and personnel expenses due to lower headcount and a $0.4 milliondecrease in professional services related to higher expenses incurred in the first quarter of 2018 for the start-up cost of Phase 1b/2 trial for vecabrutinib.
- General and administrative expense was
$2.4 millionfor the three months ended March 31, 2019, as compared to $3.4 millionfor the same period in 2018. The decrease of $1.0 millionbetween the comparable three-month periods was primarily due to a $0.7 milliondecrease in salary and personnel expenses due to lower headcount and a $0.4 milliondecrease in professional services expenses due in part to lower vosaroxin patent expenses.
- Interest expense was
$0.3 millionfor the three months ended March 31, 2019and 2018. The interest expenses from both periods resulted from payments on our Loan Agreement with Western Alliance Bankand Solar Capital Ltd.
- Cash used in operating activities was
$6.1 millionfor the three months ended March 31, 2019, as compared to $6.6 million for the same period in 2018. Net cash used in the three months ended March 31, 2019resulted primarily from the net loss of $5.9 million, partially offset by adjustments for non-cash items of $0.5 millionand changes in operating assets and liabilities of $0.7 million. Net cash used in the three months ended March 31, 2018, resulted primarily from the net loss of $7.3 millionand changes in operating assets and liabilities of $0.2 million, offset by net adjustments for non-cash items of $0.9 million.
- Loss from operations was
$5.7 millionfor the three months ended March 31, 2019, as compared to $7.1 millionfor the same period in 2018. Net loss was $5.9 millionfor the three months ended March 31, 2019, as compared to $7.3 millionfor the same period in 2018.
Conference Call Information
Sunesis will host a conference today at
Sunesis is a biopharmaceutical company developing new targeted 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 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’ 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 sufficiency of its cash resources and financial position. Words such as “appears”, “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
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended
|License and other revenue||$||-||$||237|
|Research and development||3,248||3,969|
|General and administrative||2,439||3,359|
|Total operating expenses||5,687||7,328|
|Loss from operations||(5,687||)||(7,091||)|
|Other income, net||88||99|
|Unrealized gain on available-for-sale securities||-||2|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share||59,142||34,345|
|Basic and diluted loss per common share||$||(0.10||)||$||(0.21||)|
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$||24,811||$||13,696|
|Prepaids and other current assets||1,599||1,504|
|Total current assets||26,410||15,200|
|Property and equipment, net||9||11|
|Operating lease right-of-use asset||1,226||-|
|Deposits and other assets||109||113|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||420||500|
|Other accrued liabilities||1,440||1,091|
|Operating lease liability - current||545||-|
|Total current liabilities||9,975||11,323|
|Operating lease liability - long term||681||-|
|Additional paid-in capital||656,761||642,460|
|Total stockholders’ equity||17,086||3,993|
|Total liabilities and stockholders’ equity||$||27,754||$||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:
Sunesis Pharmaceuticals Inc.
Source: Sunesis Pharmaceuticals, Inc.