Sunesis Pharmaceuticals Reports Second Quarter 2019 Financial Results and Recent Highlights
“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
“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
- 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 Congressof the European Hematology Associationin 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.
$5.5 MillionLoan. In April 2019, the Company entered into a $5.5 millionloan 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.
- Cash and cash equivalents, restricted cash, and marketable securities totaled
$17.7 millionas of June 30, 2019, as compared to $13.7 millionas of December 31, 2018. This capital, plus the approximately $25.9 millionin net proceeds from the July 2019public 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 millionwas primarily due to $19.0 millionnet proceeds from issuance of common and preferred stock, and $5.5 millionproceeds from SVB Loan Agreement, offset by $13.0 millionnet cash used in operating activities and $7.5 millionused in principal payments to repay the Company’s prior loan.
- Research and development expense was
$3.7 millionand $6.9 millionfor the three and six months ended June 30, 2019, as compared to $3.8 millionand $7.7 millionfor 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 millionand $5.0 millionfor the three and six months ended June 30, 2019, as compared to $2.8 millionand $6.2 millionfor 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 millionand $0.4 millionfor the three and six months ended June 30, 2019, as compared to $0.3 millionand $0.6 millionfor 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 millionfor the six months ended June 30, 2019, as compared to $12.4 millionfor 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 millionand 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 millionand changes in operating assets and liabilities of $0.1 million.
- Sunesis reported loss from operations of
$6.2 millionand $11.9 millionfor the three and six months ended June 30, 2019, as compared to $6.6 millionand $13.7 millionfor the same periods in 2018. Net loss was $6.2 millionand $12.1 millionfor the three and six months ended June 30, 2019, as compared to $6.8 millionand $14.1 millionfor the same periods in 2018.
Conference Call Information
Sunesis will host a conference today at
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.
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
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended
|Six months ended
|License and other revenue||$||—||$||—||$||—||$||237|
|Research and development||3,683||3,758||6,931||7,727|
|General and administrative||2,523||2,824||4,962||6,183|
|Total operating expenses||6,206||6,582||11,893||13,910|
|Loss from operations||(6,206||)||(6,582||)||(11,893||)||(13,673||)|
|Other income, net||76||29||164||128|
|Unrealized gain on available-for-sale securities||—||4||—||6|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share||72,190||34,417||65,702||34,381|
|Basic and diluted loss per common share||$||(0.09||)||$||(0.20||)||$||(0.18||)||$||(0.41||)|
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30||December 31,|
|Cash and cash equivalents||$||9,797||$||13,696|
|Prepaids and other current assets||2,159||1,504|
|Total current assets||19,842||15,200|
|Property and equipment, net||7||11|
|Operating lease right-of-use asset||1,090||—|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||525||500|
|Other accrued liabilities||656||1,091|
|Operating lease liability - current||545||—|
|Total current liabilities||8,743||11,323|
|Operating lease liability - long term||545||—|
|Convertible preferred stock||7,113||20,998|
|Additional paid-in capital||676,189||642,460|
|Total stockholders’ equity||11,739||3,993|
|Total liabilities and stockholders’ equity||$||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.|
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Source: Sunesis Pharmaceuticals, Inc.