Sunesis Pharmaceuticals Reports Second Quarter 2016 Financial Results and Recent Highlights
“During the second quarter, we strengthened the foundation of our oncology pipeline through the advancement of our vosaroxin program and lead proprietary BTK kinase inhibitor, SNS-062. Achievement of upcoming milestones from both these programs we believe will unlock significant value for the company,” said
“We are progressing our regulatory efforts to bring vosaroxin to market in
Second Quarter 2016 and Recent Highlights
- Presentation of Updated Results from MD Anderson Sponsored Trial in AML and high-risk MDS at EHA Annual Meeting. In
June 2016, results from an ongoing Phase 1B/2 University of TexasMD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodyplastic syndrome (MDS) were presented at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark. At the optimized induction dose of 70 mg/m2 of vosaroxin (n=41), the combination of vosaroxin and decitabine demonstrated a compelling CR/CRp/CRi rate of 76% and a median overall survival of 16.1 months. The oral presentation, titled “Phase I/ll study of vosaroxin and decitabine in newly diagnosed older patients with acute myeloid leukemia and high-risk myelodysplastic syndrome,” is available on the Sunesis website at www.sunesis.com.
- Presentation of Results Evaluating the Value of Complete Remission Prior to HCT in Patients with AML at ASCO Annual Meeting. In
June 2016, Sunesis presented results from a study conducted by the Center for International Blood and Marrow Transplant Research (CIBMTR) at the Medical College of Wisconsin demonstrating the significant value of achieving complete remission prior to allogeneic hematopoietic cell transplantation (HCT) in patients with acute myeloid leukemia (AML) at the 2016 American Society of Clinical Oncology. The study was funded jointly by Sunesis and CIBMTR. The poster presentation, titled “Allogeneic transplantation for advanced myelogenous leukemia: The value of complete remission,” is available on the Sunesis website at www.sunesis.com.
- Strengthened Executive Management Team and Board of Directors. In
June 2016, Sunesis announced the appointment of Linda Neuman, M.D., as Vice President, Clinical Development. In March 2016, Sunesis announced the appointment of Geoffrey Parker to the Sunesis Board of Directors.
- Supported First-Ever AML Awareness Month. In
May 2016, Sunesis announced its support for the first-ever AML Awareness Month, which was held in June with AML spokesperson and sportscaster Craig Sager. The company provided an educational grant to support the sponsor of the campaign, CancerCare.
- 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.
- Cash, cash equivalents and marketable securities totaled
$33.1 millionas of June 30, 2016, as compared to $46.4 millionas of December 31, 2015. The decrease of $13.3 millionwas primarily due to $20.1 millionof net cash used in operating activities and $8.0 millionof principal and final payments against notes payable, partially offset by $14.8 millionraised from debt financing. This capital is expected to be sufficient to fund operations to the middle of 2017.
- Revenue for the three and six months ended
June 30, 2016was $0.6 millionand $1.2 millionas compared to $0.9 millionand $1.7 millionfor the same periods 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
$6.6 millionand $12.8 millionfor the three and six months ended June 30, 2016as compared to $6.3 millionand $10.8 millionfor the same periods in 2015. The increase of $0.3 millionand $2.0 millionbetween the comparable three- and six-month periods, respectively, was primarily related to medical scientific affairs activities.
- General and administrative expense was
$4.0 millionand $8.3 millionfor the three and six months ended June 30, 2016as compared to $5.2 millionand $10.3 millionfor the same periods in 2015. The decrease of $1.2 millionand $2.0 millionbetween the comparable three- and six-month periods, respectively, was primarily due to decrease in outside services costs.
- Interest expense was
$0.5 millionand $0.8 millionfor the three and six months ended June 30, 2016as compared to $0.2 million and $0.5 millionfor the same periods in 2015.
- Net other income was nil and
$0.1 millionfor the three and six months ended June 30, 2016as compared to net other income of $1.9 millionand $1.8 millionfor the same period in 2015. The increases in 2015 periods were 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
$20.1 millionfor the six months ended June 30, 2016, as compared to $19.8 million for the same period in 2015. Net cash used in the 2016 period resulted primarily from the net loss of $20.5 millionand changes in operating assets and liabilities of $2.5 million, including the payment of a final fee of $1.2 millionunder the Oxford Loan Agreement, partially offset by net adjustments for non-cash items of $2.9 million. Net cash used in the 2015 period resulted primarily from the net loss of $18.1 millionand changes in operating assets and liabilities of $3.4 million, partially offset by net adjustments for non-cash items of $1.7 million.
- Sunesis reported loss from operations of
$10.0 millionand $19.9 millionfor the three and six months ended June 30, 2016as compared to $10.6 millionand $19.4 millionfor the same periods in 2015. Net loss was $10.4 million and $20.5million for the three and six months ended June 30, 2016, as compared to $8.9 million and $18.0million for the same periods 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
Vosaroxin’s Marketing Authorization Application for relapsed refractory AML is currently under review by the
The trademark name QINPREZO is conditionally accepted by the
SNS-062 is a novel, second-generation BTK inhibitor, a class of kinase inhibitors that selectively inhibits the enzyme Bruton's tyrosine kinase (BTK). This target mediates signaling through the B-cell receptor, which is critical for adhesion, migration, proliferation and survival of normal and malignant B-lineage lymphoid cells. Unlike other drugs in its class, SNS-062 has a distinct kinase selectivity profile and binds non-covalently to the BTK enzyme, potentially providing an opportunity to address the leading resistance mechanism, a mutation in the enzyme’s binding site required for covalent binding. In preclinical studies, SNS-062 demonstrated potent activity against Cys-481S mutated B-cell malignancies, and is currently being studied in healthy subjects in a Phase 1A, randomized, double-blind, placebo-controlled dose-ranging study to investigate the drug’s safety, pharmacokinetics, and pharmacodynamics. With a successful study outcome, SNS-062 is expected to proceed to a Phase 1B/2 study in patients with B-cell malignancies around year end 2016.
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. Currently, the company is focused on 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, timing of potential market launch in
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED BALANCE SHEETS|
|June 30,||December 31,|
|Cash and cash equivalents||$||9,447||$||26,886|
|Prepaids and other current assets||831||558|
|Total current assets||33,952||46,988|
|Property and equipment, net||8||14|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||2,006||1,954|
|Other accrued liabilities||1,858||2,711|
|Current portion of deferred revenue||1,831||2,441|
|Current portion of notes payable||833||7,834|
|Total current liabilities||10,400||18,999|
|Non-current portion of deferred revenue||-||610|
|Non-current other accrued liabilities||56|
|Non-current portion of notes payable||13,444||-|
|Additional paid-in capital||573,496||570,309|
|Accumulated other comprehensive income (loss)||1||(11||)|
|Total stockholders’ equity||10,060||27,393|
|Total liabilities and stockholders’ equity||$||33,960||$||47,002|
|Note 1: The consolidated balance sheet as of December 31, 2015 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015.|
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended
|Six months ended
|License and other revenue||$||610||$||854||$||1,250||$||1,708|
|Research and development||6,606||6,302||12,815||10,814|
|General and administrative||3,997||5,175||8,292||10,286|
|Total operating expenses||10,603||11,477||21,107||21,100|
|Loss from operations||(9,993||)||(10,623||)||(19,857||)||(19,392||)|
|Other income (expense), net||23||1,907||99||1,787|
|Unrealized gain (loss) on available-for-sale securities||(1||)||-||12||2|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share|
|Basic and diluted loss per common share|
|Note 2: The consolidated statement of operations and comprehensive loss for the year ended 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.|
Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717