Sunesis Pharmaceuticals Reports First Quarter 2016 Financial Results and Recent Highlights
“The first quarter of 2016 saw several important milestones, including, notably, the advancement of our unique BTK-inhibitor SNS-062 into the clinic in a Phase 1A study,” said
Mr. Swisher added: “We also continue to progress our efforts to bring vosaroxin to market in
First Quarter 2016 and Recent Highlights
- First Subject Dosed in Phase 1A Healthy Volunteer Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062. In
March 2016, the first patient was dosed in a Phase 1A, randomized, double-blind, placebo-controlled dose-ranging study to investigate the safety, pharmacokinetics and pharmacodynamics of its oral, next-generation, non-covalently binding BTK-inhibitor, SNS-062, in healthy subjects. If a successful outcome is achieved in Phase 1A SNS-062 is expected to proceed to a Phase 1B/2 study in patients with B-cell malignancies later this year.
$15 MillionVenture Loan. In March 2016, Sunesis entered into a $15 millionloan agreement with Bridge Bank, a division of Western Alliance Bank, and Solar Capital Ltd.The loan was used for the repayment of existing indebtedness and will be used for general corporate purposes.
- First Patient Treated in
Vanderbilt University-Sponsored Phase 2 VITAL Study of Vosaroxin in Combination with Infusional Cytarabine in Patients with Previously Untreated AML. In March 2016, the first patient was treated in an investigator-sponsored study of vosaroxin and cytarabine in adult patients with previously untreated acute myeloid leukemia (AML). The trial is being conducted at the Vanderbilt-Ingram Cancer Centerat Vanderbilt Universityunder the direction of Michael R. Savona, M.D., FACP, Associate Professor of Medicine and Director of Hematology Early Therapeutics Program, and Stephen A. Strickland, M.D., MSCI, Assistant Professor of Medicine.
- Strengthened Executive Management Team and Board of Directors. In
March 2016, Sunesis announced the appointment of Geoffrey Parkerto the Sunesis Board of Directors. In February 2016, Sunesis announced the promotion of Deborah A. Thomas, Ph.D., to the role of Senior Vice President, Regulatory Affairs, Quality Assurance, and Non-Clinical Development.
- Validation of Marketing Authorization Application by the
European Medicines Agency for Vosaroxinin AML. At year-end 2015, the European Medicines Agency(EMA) validated the Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed refractory acute myeloid leukemia (AML) in patients aged 60 years and older. Validation confirms that the submission is complete and initiates the Centralized Review process by the EMA’s Committee for Medicinal Products for Human Use(CHMP). The MAA, if authorized, provides a marketing license valid in all 28 EU member states.
- Cash, cash equivalents and marketable securities totaled
$40.0 millionas of March 31, 2016, as compared to $46.4 millionas of December 31, 2015. The decrease of $6.4 millionwas primarily due to $10.7 millionof net cash used in operating activities and $8.0 millionof principal and final payments against notes payable, partially offset by $12.3 millionraised from debt financing. An additional $2.5 millionin net loan proceeds was received on April 1, 2016. This capital is expected to be sufficient to fund operations through the second quarter of 2017.
- Revenue for the three months ended
March 31, 2016was $0.6 million, as compared to $0.9 millionfor the same period in 2015. The decrease between the periods was primarily due to the increase in estimated performance period through which the remaining balance of deferred revenue will be amortized.
- Research and development expense was
$6.2 millionfor the three months ended March 31, 2016as compared to $4.5 millionfor the same period in 2015. The increase between the periods was primarily due to the increase of $1.3 millionin consulting and other outside services costs and $0.4 millionin clinical trials and medical affairs expenses.
- General and administrative expense was
$4.3 millionfor the three months ended March 31, 2016as compared to $5.1 millionfor the same period in 2015. The decrease between the periods was primarily due to a $0.8 milliondecrease in personnel costs and professional services and commercial costs.
- Interest expense was
$0.3 millionfor the three months ended March 31, 2016, compared to $0.2 millionfor the same period in 2015.
- Net other income was nil for the three months ended
March 31, 2016as compared to net other expense of $0.1 millionfor the same period in 2015. The amount for the period in 2015 was primarily comprised of non-cash credits or charges for the revaluation of warrants issued in the October 2010underwritten offering.
- Cash used in operating activities was
$10.7 millionfor the three months ended March 31, 2016, including a $0.5 millionmilestone payment relating to the MAA filing, as compared to $11.6 millionfor the same period in 2015.
- Sunesis reported loss from operations of
$9.9 millionfor the three months ended March 31, 2016as compared to $8.8 millionfor the same period in 2015. Net loss was $10.1 million for the three months ended March 31, 2016, as compared to $9.1 million for the same period in 2015.
Conference Call Information
Sunesis will host an update conference call today,
About QINPREZO™ (vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the
The trademark name QINPREZO is conditionally accepted by the
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to improving the lives of people with cancer and is currently pursuing regulatory approval in
For additional information on Sunesis, please visit http://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' corporate objectives, including the anticipated progress and potential approval of vosaroxin by the EMA, clinical development of SNS 062, potential ex-US partnership, the expected progress in its kinase inhibitor pipeline, and the sufficiency of Sunesis’ cash resources. Words such as “expect,” “look forward,” "potential," "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 that Sunesis may not be able to receive regulatory approval of vosaroxin in the U.S. or
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$||23,858||$||26,886|
|Prepaids and other current assets||701||558|
|Total current assets||40,717||46,988|
|Property and equipment, net||11||14|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||2,185||1,954|
|Other accrued liabilities||1,639||2,711|
|Current portion of deferred revenue||2,441||2,441|
|Current portion of notes payable||-||7,834|
|Total current liabilities||9,775||18,999|
|Non-current portion of deferred revenue||-||610|
|Non-current portion of notes payable||11,685||-|
|Additional paid-in capital||572,257||570,309|
|Accumulated other comprehensive loss||2||(11||)|
|Total stockholders’ equity||19,268||27,393|
|Total liabilities and stockholders’ equity||$||40,728||$||47,002|
|Note 1: The consolidated balance sheet as of December 31, 2015 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015.|
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended
|License and other revenue||$||640||$||854|
|Research and development||6,209||4,512|
|General and administrative||4,295||5,111|
|Total operating expenses||10,504||9,623|
|Loss from operations||(9,864||)||(8,769||)|
|Other income (expense), net||76||(120||)|
|Unrealized gain (loss) on available-for-sale securities||13||2|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share||86,660||67,641|
|Basic and diluted loss per common share||$||(0.12||)||$||(0.13||)|
Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717