Sunesis Pharmaceuticals Reports Third Quarter 2017 Financial Results and Recent Highlights
“In the third quarter, we advanced our lead program, a reversible, non-covalent BTK inhibitor, SNS-062, with the ongoing enrollment in our Phase 1b/2 study in patients with relapsed chronic lymphocytic leukemia (CLL) and other B-cell malignancies,” said Daniel Swisher, Chief Executive Officer of Sunesis. “We will provide a program update at an investor presentation and webcast during the
Mr. Swisher added, “Beyond SNS-062, we have made progress with our proprietary PDK-1 and Takeda-partnered pan-RAF inhibitor programs. We are pleased to announce today the nomination of our PDK1 (phosphatidyl-inositol dependent kinase1) inhibitor, SNS-510, as a Development Candidate and potentially first-to-clinic selective inhibitor in this pathway. 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. In addition, we look forward to announcing future updates from the ongoing clinical studies of our Takeda-partnered TAK-580 program.”
$20 millionconcurrent public offerings with leading life science investors. On October 27, 2017, Sunesis raised $20 millionin gross proceeds in concurrent underwritten public offerings of common and preferred stock and warrants, with participation by new and existing investors, including Oncology Impact Fundmanaged by MPM Capital, BVF Partners L. P and Burrage Capital.
Progressin Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic Lymphocytic Leukemia (CLL) and other B-Cell Malignancies. In July 2017, Sunesis announced that the first patient was dosed at the Dana-Farber Cancer Institutein the Phase 1b/2 dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of its potent, reversible, non-covalent BTK-inhibitor, SNS-062, in adults with CLL, small lymphocytic leukemia, Waldenstrom’s macroglobulinemia, and mantle cell lymphoma. The Phase 1b/2 trial is an open-label, sequential-group study that is enrolling up to 124 subjects across leading sites in the United States. The Company plans to present interim data from this study in mid-2018.
- Cash, cash equivalents and marketable securities totaled
$12.5 millionas of September 30, 2017, as compared to $42.6 millionas of December 31, 2016. The decrease of $30.1 millionwas primarily due to $30.8 millionof net cash used in operating activities and a debt restructuring payment of $7.6 million, partially offset by $8.3 million in net proceeds primarily from sales of common stock through the company’s at the market facility. An additional $24.6 million in net proceeds were raised in October, resulting in pro-forma September 30, 2017cash, cash equivalents and marketable securities of $37.1 million. This capital is expected to fund the company into 2019.
- Revenue for the three and nine months ended
September 30, 2017was nil and $0.7 million, as compared to $0.6 millionand $1.9 millionfor the same periods in 2016. Revenue in each period was primarily due to deferred revenue recognized related to the Royalty Agreement with Royalty Pharma.
- Research and development expense was
$6.8 millionand $17.9 millionfor the three and nine months ended September 30, 2017as compared to $5.3 millionand $18.1 millionfor the same periods in 2016, primarily relating to the SNS-062 and the vosaroxin development program in each period. The increase of $1.5 millionbetween the comparable three month periods was primarily due to the $2.5 millionmilestone payment to Biogen under the license agreement, offset by decreases in professional services of $0.8 millionand salary and personnel expenses of $0.2 million. The decrease in the comparable nine months periods of $0.2 millionwas primarily due to a decrease in professional services of $2.5 million, salary and personnel expenses of $0.2 million, and medical affairs expenses of $0.2 million, partially offset by the $2.5 millionmilestone payment to Biogen under the license agreement.
- General and administrative expense was
$3.2 millionand $10.8 millionfor the three and nine months ended September 30, 2017, as compared to $3.9 millionand $12.2 millionfor the same periods in 2016. The decrease of $0.7 millionfor the comparable three month periods was primarily due to decreases in salary and personnel expenses of $0.4 millionand commercial expenses of $0.3 million, partially offset by increases of $0.1 millionin professional services. The decrease in the comparable nine months periods of $1.4 millionwas primarily due to a decrease in salary and related expenses of $0.9 million, commercial expenses of $0.7 million, partially offset by increase of $0.4 millionin professional services.
- Interest expense was
$0.3 millionand $1.1 millionfor the three and nine months ended September 30, 2017, as compared to $0.5 million and $1.2 millionfor the same periods in 2016. The decrease in the 2017 periods was primarily due to the decrease in the outstanding notes payable.
- Net other income was
$0.1 millionand $0.3 millionfor the three and nine months ended September 30, 2017, as compared to nil and $0.1 millionfor the same periods in 2016. The other income was primarily comprised of interest income from the short-term investments.
- Cash used in operating activities was
$30.8 millionfor the nine months ended September 30, 2017, as compared to $29.0 million for the same period in 2016. Net cash used in the 2017 period resulted primarily from the net loss of $28.8 millionand changes in operating assets and liabilities of $4.6 million, offset by net adjustments for non-cash items of $2.6 million. Net cash used in the nine month period ended September 30, 2016resulted primarily from the net loss of $29.5 millionand changes in operating assets and liabilities of $3.6 million, including a final payment fee representing interest expense of $1.2 millionunder the Oxford Loan Agreement, partially offset by net adjustments for non-cash items of $4.1 million.
- Sunesis reported loss from operations of
$9.9 millionand $28.0 millionfor the three and nine months ended September 30, 2017, as compared to $8.5 millionand $28.4 millionfor the same periods in 2016. Net loss was $10.2 millionand $28.8 millionfor the three and nine months ended September 30, 2017, as compared to $9.0 millionand $29.5 millionfor the same periods in 2016.
Conference Call Information
Sunesis will host a conference today at
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the future treatment of solid and hematologic cancers. Sunesis has built an experienced cancer 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 establishing proof of concept that its oral non-covalent BTK-inhibitor, SNS-062, is effective in ibrutinib-resistant chronic lymphocytic leukemia. SNS-062 is currently being evaluated in a Phase 1b/2, open-label, sequential-group, dose-escalation and cohort-expansion study in adults with chronic lymphocytic leukemia, Waldenstrom’s macroglobulinemia and mantle cell lymphoma that have progressed after prior therapies. Beyond the development of SNS-062, the Company has two other kinase inhibitor programs, including the Takeda-partnered pan-RAF inhibitor TAK-580, which is in solid tumor trials, and its proprietary preclinical PDK1 inhibitor SNS-510, which has completed non-GLP toxicology studies and has been nominated as a Development Candidate. 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.
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 continued development of SNS-062, including the timing of our Phase 1b/2 trial of SNS-062 and the therapeutic potential of SNS-062, further development of its kinase inhibitor pipeline, business development alternatives for vosaroxin, planned development of SNS-510 and the sufficiency of Sunesis’ cash and funding into early 2019. Words such as “continue,” “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 SNS-062 Phase 1b/2 trial, the risk that Sunesis' clinical or preclinical studies for SNS-062, vosaroxin, 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 SNS-062, vosaroxin or SNS-510 could be otherwise halted or significantly delayed for various reasons, that Sunesis may not be able to receive regulatory approval of SNS-062, vosaroxin or SNS-510 in the U.S. or Europe, and risks related to Sunesis' ability to raise the capital that it believes to be accessible and is required to fully finance the development and commercialization of SNS-062, vosaroxin, SNS-510 and other product candidates. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 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 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.|
|CONSOLIDATED BALANCE SHEETS|
|September 30,||December 31,|
|Cash and cash equivalents||$||7,947||$||8,056|
|Prepaids and other current assets||1,258||643|
|Total current assets||13,711||43,231|
|Property and equipment, net||22||3|
|Deposits and other assets||1,335|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||765||1,434|
|Other accrued liabilities||1,056||1,691|
|Current portion of deferred revenue||-||610|
|Current portion of notes payable||2,500||3,333|
|Total current liabilities||7,443||10,939|
|Non-current portion of notes payable||4,652||11,102|
|Other accrued liabilities||68||169|
|Additional paid-in capital||612,595||599,632|
|Accumulated other comprehensive income (loss)||(1||)||(22||)|
|Total stockholders’ equity||2,905||21,024|
|Total liabilities and stockholders’ equity||15,068||43,234|
|Note 1: The consolidated balance sheet as of December 31, 2016 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2016.|
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended
|Nine months ended
|License and other revenue||$||-||$||610||$||669||$||1,860|
|Research and development||6,763||5,251||17,866||18,066|
|General and administrative||3,175||3,889||10,788||12,181|
|Total operating expenses||9,938||9,140||28,654||30,247|
|Loss from operations||(9,938||)||(8,530||)||(27,985||)||(28,387||)|
|Other income (expense), net||67||49||266||148|
|Unrealized gain (loss) on available-for-sale securities||8||(6||)||21||6|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share||23,678||14,503||22,106||14,480|
|Basic and diluted loss per common share||$||(0.43||)||$||(0.62||)||$||(1.30||)||$||(2.04||)|
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