Sunesis Pharmaceuticals Reports Third Quarter 2014 Financial Results and Recent Highlights
Announces Submission of Letter of Intent to File MAA for Vosaroxin in Relapsed or Refractory AML With the
Announces Upcoming Presentations at ASH Annual Meeting, EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics
Sunesis to Host Conference Call Today at
"VALOR represents the largest randomized company-sponsored dataset in the relapsed and refractory AML setting," said
Mr. Swisher continued: "As an important step forward in the European regulatory process, we announced today the submission of a letter of intent to file an MAA for vosaroxin in relapsed or refractory AML with the EMA. Further, we are requesting a meeting with the
Third Quarter 2014 and Recent Highlights
Announced results from pivotal Phase 3 VALOR trial of vosaroxin and cytarabine in patients with first relapsed or refractory acute myeloid leukemia. In
October 2014, Sunesis announced results from the Phase 3 VALOR trial, a randomized, double-blind, placebo-controlled trial of vosaroxin and cytarabine in patients with first relapsed or refractory acute myeloid leukemia (AML). At more than 100 leading international sites, the trial enrolled 711 patients, who were stratified for age, geographic region and disease status. The VALOR trial did not meet its primary endpoint of demonstrating a statistically significant improvement in overall survival, as results showed a median overall survival of 7.5 months for patients receiving vosaroxin and cytarabine compared to 6.1 months for patients receiving placebo and cytarabine (HR=0.865, p=0.06). In a pre-planned analysis accounting for the stratification factors at randomization, a significant improvement in overall survival was demonstrated (HR=0.830, p=0.02).
Given the complexity of interpreting the impact of transplantation therapy, a predefined analysis of overall survival censoring for hematopoietic stem cell transplantation was planned. In this analysis, patients receiving the vosaroxin combination had a median overall survival of 6.7 months versus 5.3 months for patients receiving placebo and cytarabine (HR=0.809, p=0.02). The VALOR trial also demonstrated a clinically significant benefit in complete remission, or CR, rate (30.1% vs 16.3%, p=0.0000147), the secondary endpoint.
The safety profile of the vosaroxin combination was consistent with that observed in previous company trials, and induction mortality was balanced between arms. 30-day and 60-day all-cause mortality were comparable between the trial arms (7.9% versus 6.6% and 19.7% versus 19.4%, for the vosaroxin combination versus placebo and cytarabine, respectively).
Announces submission of Letter of Intent to file a Marketing Authorization Application (MAA) for vosaroxin in relapsed or refractory AML with the
European Medicines Agency(EMA). Sunesis announced today that the company has submitted a letter of intent describing the company's intention to file a Marketing Authorization Application (MAA) with the European Medicines Agency(EMA) seeking marketing authorization of vosaroxin plus cytarabine for the treatment of relapsed or refractory acute myeloid leukemia. The letter of intent initiates the process for the assignment of a Rapporteur and Co-Rapporteur, who are two appointed members of the Committee for Human Medicinal Products (CHMP). The CHMP is the committee responsible for preparing the EMA's opinions on questions concerning human medicines. The Rapporteur and Co-Rapporteur will assess the MAA and provide the CHMP with the result of their analysis, which will be the basis of the conclusions of the CHMP. Sunesis expects to file its MAA in the second half of 2015.
Announces upcoming presentations at 56th
American Society of Hematology(ASH) Annual Meeting. Sunesis announced today that two AML studies will be presented at the 56th ASH Annual Meeting, taking place December 6-9, 2014, in San Francisco, CA. The first study, titled "Phase I/II Study of Vosaroxin and Decitabine in Newly Diagnosed Older Patients with Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome," (Abstract #75224) will be presented in an oral session on Monday, December 8th at 10:30 a.m. The presentation will include results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsoredtrial of vosaroxin in combination with decitabine in older patients with previously untreated AML and high-risk myelodysplastic syndrome. The second study, titled "Prevalence and Incidence of Acute Myeloid Leukemia May be Higher than Currently Accepted Estimates Among the ≥65 Year-Old Population in the United States," (Abstract #72296) will be presented in a poster session on Saturday, December 6th at 5:30 p.m. The presentations were announced as part of the meeting's regular abstract selection schedule.
Announces upcoming presentations of MLN2480 clinical and preclinical studies at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Sunesis announced today that four preclinical and clinical presentations on MLN2480, an oral, investigative agent for pan-Raf kinase inhibition, will be presented by
Millennium Pharmaceuticals, Inc.("Millennium"), a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, taking place November 18-21, 2014, in Barcelona, Spain. MLN2480 is being developed by Millennium through an exclusive license from Sunesis, which includes an option for co-development by Sunesis. The presentations are expected to include data from a Phase 1, multicenter, open-label, dose escalation study designed to evaluate the safety, tolerability and maximum tolerated dose of single agent MLN2480.
Announced acceptance of Pediatric Investigation Plan by EMA for vosaroxin. In
July 2014, Sunesis announced that the Pediatric Committee of the EMA issued a positive opinion on the company's Pediatric Investigation Plan (PIP) for vosaroxin. A PIP is part of the EMA approval process and must be accepted prior to submission of an MAA for the drug in the European Union. A PIP describes how a company intends to evaluate the use of a given drug in children. The completion of studies outlined in the PIP is not required prior to any European Unionapproval for vosaroxin as a deferral for completion has been received.
Cash, cash equivalents and marketable securities totaled
$44.7 millionas of September 30, 2014, as compared to $39.3 millionas of December 31, 2013. The increase of $5.4 millionwas primarily due to net proceeds of $44.7 millionfrom the sale of common stock and warrants, and $1.8 millionfrom the exercise of warrants, stock options and stock purchase rights, partially offset by $34.2 millionof net cash used in operating activities and $6.9 millionof principal payments against notes payable. As of September 30, 2014, outstanding debt totaled $11.6 million.
Revenue for the three and nine months ended
September 30, 2014was $0.9 millionand $4.8 million, as compared to $2.0 millionand $6.0 millionfor the same periods in 2013. Revenue in each period was primarily due to deferred revenue recognized related to the royalty agreement with Royalty Pharma.
Research and development expense was
$6.9 millionand $21.7 millionfor the three and nine months ended September 30, 2014, as compared to $7.0 millionand $22.0 millionfor the same periods in 2013, primarily relating to the vosaroxin development program in each period. The decreases between the comparable three and nine month periods were primarily due to reduced clinical trial expenses, partially offset by increases in personnel, drug manufacturing and other outside services costs, including those related to the company's kinase inhibitor programs.
General and administrative expense was
$7.2 millionand $17.0 millionfor the three and nine months ended September 30, 2014, as compared to $2.8 millionand $8.1 millionfor the same periods in 2013. The increases between the comparable three and nine month periods were primarily due to increased personnel and consulting costs, primarily related to commercial planning and medical affairs.
Interest expense was
$0.4 millionand $1.4 millionfor the three and nine months ended September 30, 2014, as compared to $0.7 million and $2.3 millionfor the same periods in 2013. The decreases in 2014 were due to the reduced principal balance outstanding on notes payable.
Net other expense was
$1.6 millionfor the three months ended September 30, 2014, as compared to net other income of $0.9 millionfor the same period in 2013. Net other expense was $6.4 millionfor the nine months ended September 30, 2014, as compared to $0.9 millionfor the same period in 2013. The amounts for each period were primarily comprised of non-cash credits or charges for the revaluation of warrants issued in the October 2010underwritten offering.
Cash used in operations was
$34.2 million for the nine months ended September 30, 2014, as compared to $27.7 million for the same period in 2013. Net cash used in the 2014 period resulted primarily from the net loss of $41.7 millionand changes in operating assets and liabilities of $3.4 million, partially offset by net adjustments for non-cash items of $11.0 million.
Net loss was
$15.3 millionand $41.7 millionfor the three and nine months ended September 30, 2014, as compared to $7.6 millionand $27.4 millionfor the same periods in 2013.
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 QINPREZO 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
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow.
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.
For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logos are trademarks of
This press release contains forward-looking statements, including statements related to Sunesis' regulatory strategy (including plans to commence a marketing authorization filing with the EMA), Sunesis' preliminary analysis, assessment and conclusions of the results of the VALOR trial, and the efficacy and commercial potential of vosaroxin and clinical progress of other product candidates. It is possible that such results or conclusions may change based on further analysis of the VALOR data. Words such as "approximately," "believe," "continue," "could," "determine," "estimate," "expect," "intends," "may," "plans," "potential," "seek," "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' preliminary analysis, assessment and conclusions of the results of the VALOR trial set forth in this release may change based on further analysis of such data, the risk that Sunesis' plans to commence a marketing authorization filing with the EMA may change or such filing may be rejected by the EMA, and the risk that Sunesis' clinical studies for vosaroxin and other product candidates may not lead to regulatory approval. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Annual Report on Form 10-K for the year ended
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED BALANCE SHEETS|
|September 30,||December 31,|
|Cash and cash equivalents||$ 20,807||$ 15,121|
|Prepaids and other current assets||1,279||1,199|
|Total current assets||45,998||40,492|
|Property and equipment, net||53||23|
|Deposits and other assets||--||10|
|Total assets||$ 46,051||$ 40,525|
|LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)|
|Accounts payable||$ 772||$ 953|
|Accrued clinical expense||3,621||4,750|
|Other accrued liabilities||3,967||1,645|
|Current portion of deferred revenue||3,418||7,956|
|Current portion of notes payable||9,859||9,018|
|Total current liabilities||37,305||33,972|
|Non-current portion of deferred revenue||3,418||3,712|
|Non-current portion of notes payable||1,713||9,025|
|Stockholders' equity (deficit):|
|Additional paid-in capital||524,992||473,509|
|Accumulated other comprehensive loss||(9)||(3)|
|Total stockholders' equity (deficit)||3,615||(6,184)|
|Total liabilities and stockholders' equity (deficit)||$ 46,051||$ 40,525|
|Note 1: The consolidated balance sheet as of December 31, 2013 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, 2013.|
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended September 30,||Nine months ended September 30,|
|License and other revenue||$ 854||$ 1,989||$ 4,838||$ 5,967|
|Research and development||6,939||6,957||21,697||22,008|
|General and administrative||7,226||2,807||17,030||8,140|
|Total operating expenses||14,165||9,764||38,727||30,148|
|Loss from operations||(13,311)||(7,775)||(33,889)||(24,181)|
|Other income (expense), net||(1,623)||863||(6,382)||(946)|
|Unrealized gain (loss) on available-for-sale securities||(2)||9||(6)||(29)|
|Comprehensive loss||$ (15,327)||$ (7,598)||$ (41,685)||$ (27,450)|
|Basic and diluted loss per common share:|
|Basic||$ (15,325)||$ (7,607)||$ (41,679)||$ (27,421)|
|Diluted||$ (15,325)||$ (8,329)||$ (41,679)||$ (27,421)|
|Shares used in computing net loss per common share:|
|Net loss per common share:|
|Basic||$ (0.25)||$ (0.15)||$ (0.71)||$ (0.53)|
|Diluted||$ (0.25)||$ (0.16)||$ (0.71)||$ (0.53)|
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals, Inc.650-266-3717