Sunesis Pharmaceuticals Reports Third Quarter 2018 Financial Results and Recent Highlights
Sunesis to Host Conference Call Today at
“We remain focused on advancing our non-covalent BTK inhibitor vecabrutinib to help patients who have developed resistance to covalent BTK inhibitors such as ibrutinib,” said
- Announced Presentations at ASH Annual Meeting. In
November 2018, the Company announced that three presentations will be made at the 60th American Society of Hematology(ASH) Annual Meeting to be held December 1-4, 2018in San Diego, California. Among the abstracts is an update on the Phase 1b/2 trial of vecabrutinib, titled “Preliminary Safety, Pharmacokinetic, and Pharmacodynamic Results from a Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton's Tyrosine Kinase Inhibitor (BTKi), Vecabrutinib, in B-Lymphoid Malignancies,” (Publication 3141) which will be presented on Sunday, December 2, in a session titled “CLL: Therapy, excluding Transplantation: Poster II,” (Session 642) from 6:00-8:00pmat the San Diego Convention Center, Hall GH. The other poster, titled “Vecabrutinib Is Efficacious In Vivo in a Preclinical CLL Adoptive Transfer Model” will be presented on Saturday, December 1, and an oral presentation “High Prevalence of BTK Mutations on Ibrutinib Therapy after 3 Years of Treatment in a Real-Life Cohort of CLL Patients: A Study from the French Innovative Leukemia Organization (FILO) Group” will be presented in sessions on Monday, December 3. The posters will be available on the Sunesis website following the presentations.
- Expanded Clinical Trial Sites. In the third quarter, we added three additional clinical sites to our Phase 1b/2 trial:
Memorial Sloan Kettering Cancer Center, Moffitt Cancer Centerand University California San Diego. We continue to identify and prepare for adding additional sites as we continue dose escalation and prepare for the Phase 2 expansion portion of the study.
- Cash and cash equivalents totaled
$20.2 millionas of September 30, 2018, as compared to $31.8 millionin cash, cash equivalents, and marketable securities as of December 31, 2017. This capital is expected to fund the company into the second quarter of 2019. The nine-month decrease of $11.6 millionwas primarily due to $17.9 millionof net cash used in operating activities, partially offset by $6.3 millionin net cash flows from financing activities.
- Research and development expense was
$3.6 millionand $11.3 millionfor the three and nine months ended September 30, 2018, as compared to $6.8 millionand $17.9 millionfor the same periods in 2017, primarily relating to the vecabrutinib and the vosaroxin development program in each period. The decreases of $3.2 millionand $6.6 millionbetween the comparable periods from last year was primarily due to a $2.5 millionmilestone payment made during the third quarter of 2017 to Biogen under the license agreement, a decrease in salary and personnel expenses, a decrease in professional services, and clinical trial expenses related to higher expenses incurred in 2017 due to the MAA with the EMA.
- General and administrative expense was
$2.7 millionand $8.9 millionfor the three and nine months ended September 30, 2018, as compared to $3.2 millionand $10.8 millionfor the same periods in 2017. The decreases of $0.5 millionand $1.9 millionbetween the comparable periods in 2017 were primarily due to reduced professional services, personnel, and commercial expenses.
- Interest expense was
$0.3 millionand $0.9 millionfor the three and nine months ended September 30, 2018, as compared to $0.3 millionand $1.1 millionfor the same periods in 2017. The decrease during the nine months period was primarily due to the decrease in the outstanding notes payable.
- Cash used in operating activities was
$17.9 millionfor the nine months ended September 30, 2018, as compared to $30.8 millionfor the same period in 2017. Net cash used in the 2018 periods resulted primarily from the net loss of $20.6 million, partly offset by net adjustments for non-cash items of $2.3 millionand changes in operating assets and liabilities of $0.4 million. 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, partly offset by net adjustments for non-cash items of $2.6 million.
- Loss from operations was
$6.3 millionand $20.0 millionfor the three and nine months ended September 30, 2018, as compared to $9.9 millionand $28.0 millionfor the same periods in 2017. Net loss was $6.5 millionand $20.6 millionfor the three and nine months ended September 30, 2018, as compared to $10.2 millionand $28.8 millionfor the same periods in 2017.
Conference Call Information
Sunesis will host a conference today at
Sunesis is a biopharmaceutical company developing new therapeutics for the treatment of hematologic and solid cancers. Sunesis has built an experienced 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 its oral non-covalent BTK inhibitor vecabrutinib. Vecabrutinib is currently being evaluated in a Phase 1b/2 study in adults with chronic lymphocytic leukemia and other B-cell malignancies that have progressed after prior therapies. The Company’s proprietary PDK1 inhibitor SNS-510 is in preclinical development. 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. Sunesis plans to submit an IND for SNS-510 in 2019. Sunesis is exploring strategic alternatives for vosaroxin, a late-stage investigational product for relapsed or refractory AML. Sunesis also has an interest in the pan-RAF inhibitor TAK-580 which is licensed to Takeda. TAK-580 is in a clinical trial for pediatric low-grade glioma.
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 Sunesis’ cash sufficiency forecast, the continued development of vecabrutinib (SNS-062), including the timing of Phase 1b/2 trial of vecabrutinib and the therapeutic potential of vecabrutinib, further development and potential of its kinase inhibitor pipeline, and planned development of SNS-510 and TAK-580. Words such as “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 the vecabrutinib Phase 1b/2 trial, the risk that Sunesis' clinical or preclinical studies for vecabrutinib, 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 vecabrutinib or SNS-510 could be otherwise halted or significantly delayed for various reasons, that Sunesis may not be able to receive regulatory approval of vecabrutinib, or SNS-510 in the U.S. or
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended
|Nine months ended
|License and other revenue||$||-||$||-||$||237||$||669|
|Research and development||3,587||6,763||11,314||17,866|
|General and administrative||2,690||3,175||8,873||10,788|
|Total operating expenses||6,277||9,938||20,187||28,654|
|Loss from operations||(6,277||)||(9,938||)||(19,950||)||(27,985||)|
|Other income, net||63||67||191||266|
|Unrealized gain on available-for-sale securities||1||8||7||21|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted
loss per common share
|Basic and diluted loss per common share||$||(0.18||)||$||(0.43||)||$||(0.59||)||$||(1.30||)|
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|September 30,||December 31,|
|Cash and cash equivalents||$||20,162||$||26,977|
|Prepaids and other current assets||1,302||1,183|
|Total current assets||21,464||32,933|
|Property and equipment, net||14||20|
|Deposits and other assets||108||1,381|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||644||767|
|Other accrued liabilities||1,831||1,570|
|Total current liabilities||12,286||12,678|
|Commitments and contingencies|
|Additional paid-in capital||641,798||633,436|
|Accumulated other comprehensive loss||-||(7||)|
|Total stockholders’ equity||9,296||21,544|
|Total liabilities and stockholders’ equity||$||21,586||$||34,334|
|Note 1: The consolidated balance sheet as of December 31, 2017 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, 2017.|
|Investor and Media Inquiries:
Sunesis Pharmaceuticals Inc.
Source: Sunesis Pharmaceuticals, Inc.