Sunesis Pharmaceuticals Reports Third Quarter 2016 Financial Results and Recent Highlights
“Since the beginning of the third quarter we have made significant progress in advancing both our vosaroxin and BTK inhibitor programs. In addition, in October, we secured the financial resources from leading life sciences investors which will help us reach several potential value inflection points,” said
“The European regulatory review of vosaroxin has now resumed, following our response to the Day 120 List of Questions, and we look forward to receiving the EMA Day 180 List of Outstanding Issues before year-end. We were also pleased to present Phase 1A Healthy Volunteer Study results demonstrating a favorable safety, pharmacokinetic and pharmacodynamic profile for SNS-062 at the
Third Quarter 2016 and Recent Highlights
- Submission of Responses to the EMA Day 120 List of Questions for the Marketing Authorization Application for Vosaroxin. In October, Sunesis announced that it submitted its responses to European Medicines Agency (EMA) Day 120 List of Questions issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization Application (MAA) for vosaroxin based on data from the VALOR trial, as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older. Sunesis expects to receive the EMA Day 180 List of Outstanding Issues before year-end.
- Presentation of Dose Escalation Results from the Phase 1A Healthy Volunteer Study Evaluating Oral Non-Covalent BTK inhibitor SNS-062. In September, Sunesis announced results from the Company’s Phase 1A study in healthy volunteers evaluating oral non-covalent BTK inhibitor SNS-062. The study demonstrated a favorable safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile for SNS-062 in healthy subjects. The results were presented on Saturday, September 10th at the European School of Haematology’s (ESH) 2nd International Conference on New Concepts in B-Cell Malignancies at the Estoril Congress Centre in Estoril, Portugal. The presentation, titled “A Phase 1A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of the Noncovalent Bruton Tyrosine Kinase (BTK) Inhibitor SNS-062 in Healthy Subjects: Preliminary Results” is available on the Sunesis website at www.sunesis.com.
- Completion of
$25.9 millionFinancing. In October, Sunesis announced the completion of an equity financing with net proceeds of $25.9 million. The financing attracted participation from leading biotechnology investors.
- Announced Publication in “Drugs”
Detailing Molecular and Pharmacologic Propertiesof Vosaroxin. In August, Sunesis announced the publication of an article detailing the molecular and pharmacologic properties of vosaroxin as a new therapeutic for acute myeloid leukemia (AML) in the journal Drugs. Vosaroxin is the first quinolone-based topoisomerase II inhibitor studied in clinical trials in oncology. The article, titled “Molecular and Pharmacologic Properties of the Anticancer Quinolone Derivative Vosaroxin: A New Therapeutic for Acute Myeloid Leukemia,” is available online and appeared in the September 2016 print issue of Drugs. The authors describe how the unique chemical and pharmacologic characteristics of vosaroxin may contribute to the efficacy and safety profile observed in Sunesis’ Phase 3 VALOR trial in first relapsed or refractory AML.
- Cash, cash equivalents and marketable securities totaled
$24.3 millionas of September 30, 2016, as compared to $46.4 millionas of December 31, 2015. The decrease of $22.1 millionwas primarily due to $28.9 millionof net cash used in operating activities, $8.0 millionof payments against notes payable, partially offset by $14.8 million in net loan proceeds. An additional $25.9 million in net proceeds was raised in the October 2016equity financing, resulting in pro-forma September 30, 2016cash, cash equivalents and marketable securities of $50.2 million. This capital is expected to be sufficient to fund operations into 2018.
- Revenue for the three and nine months ended
September 30, 2016was $0.6 millionand $1.9 millionas compared to $0.7 millionand $2.4 millionfor the same periods in 2015. The decrease between the periods was primarily due to the extension of the amortization period of our deferred revenue.
- Research and development expense was
$5.3 millionand $18.1 millionfor the three and nine months ended September 30, 2016as compared to $5.3 millionand $16.1 millionfor the same periods in 2015. The increase of $2.0 millionbetween the comparable nine month periods was primarily due to an increase in professional services, clinical trials and medical affairs expenses.
- General and administrative expense was
$3.9 millionand $12.2 millionfor the three and nine months ended September 30, 2016as compared to $4.0 millionand $14.3 millionfor the same periods in 2015. The decrease of $0.1 millionbetween the comparable three month periods was primarily due to a decrease in personnel expenses. The decrease of $2.1 millionbetween the comparable nine month periods was primarily due to decrease in outside service costs.
- Interest expense was
$0.5 millionand $1.2 millionfor the three and nine months ended September 30, 2016as compared to $0.2 millionand $0.7 millionfor the same periods in 2015. The increases in the 2016 periods were primarily due to the increase in the notes payable.
- Net other income was nil and
$0.1 millionfor the three and nine months ended September 30, 2016as compared to net other income of $1.8 millionand $3.6 millionfor the same period in 2015. The decrease in net other income is related to the quarterly re-valuation of warrant liabilities.
- Cash used in operating activities was
$29.0 millionfor the nine months ended September 30, 2016, as compared to $29.5 million for the same period in 2015. Net cash used in the 2016 period resulted primarily from the net loss of $29.5 millionand changes in operating assets and liabilities of $3.6 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 $4.1 million. Net cash used in the 2015 period resulted primarily from the net loss of $25.1 millionand changes in operating assets and liabilities of $5.6 million, partially offset by net adjustments for non-cash items of $1.2 million.
- Sunesis reported loss from operations of
$8.5 millionand $28.4 millionfor the three and nine months ended September 30, 2016as compared to $8.6 millionand $28.0 millionfor the same periods in 2015. Net loss was $9.0 million and $29.5million for the three and nine months ended September 30, 2016, as compared to $7.0 million and $25.1million 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. This alternate binding site potentially provides 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 has been 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 the reported successful study outcome, SNS-062 is proceeding to a Phase 1B/2 study in patients with B-cell malignancies.
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 regulatory development and potential approval of vosaroxin by the EMA, potential collaborations and ability to commercialize vosaroxin in
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED BALANCE SHEETS|
|September 30,||December 31,|
|Cash and cash equivalents||$||5,825||$||26,886|
|Prepaids and other current assets||840||558|
|Total current assets||25,092||46,988|
|Property and equipment, net||6||14|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||1,635||1,954|
|Other accrued liabilities||1,549||2,711|
|Current portion of deferred revenue||1,221||2,441|
|Current portion of notes payable||2,083||7,834|
|Total current liabilities||10,501||18,999|
|Non-current portion of deferred revenue||-||610|
|Non-current other accrued liabilities||113|
|Non-current portion of notes payable||12,273||-|
|Additional paid-in capital||574,615||570,317|
|Accumulated other comprehensive income (loss)||(5||)||(11||)|
|Total stockholders’ equity||2,211||27,393|
|Total liabilities and stockholders’ equity||$||25,098||$||47,002|
|Note 1: The consolidated balance sheet as of December 31, 2015 (as adjusted for the Reverse Split), has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015.|
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended
|Nine months ended
|License and other revenue||$||610||$||683||$||1,860||$||2,391|
|Research and development||5,251||5,259||18,066||16,073|
|General and administrative||3,889||3,994||12,181||14,280|
|Total operating expenses||9,140||9,253||30,247||30,353|
|Loss from operations||(8,530||)||(8,570||)||(28,387||)||(27,962||)|
|Other income (expense), net||49||1,782||148||3,569|
|Unrealized gain (loss) on available-for-sale securities||(6||)||3||6||5|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share||14,503||12,463||14,480||11,945|
|Basic and diluted loss per common share||$||(0.62||)||$||(0.56||)||$||(2.04||)||$||(2.10||)|
|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