Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2017 Financial Results and Recent Highlights
Sunesis to Host Conference Call Today at
“We are excited about the potential opportunity for our lead program, the non-covalent BTK inhibitor vecabrutinib (SNS-062), to help patients who have developed resistance to covalent BTK inhibitors such as ibrutinib, the current standard of care in treating CLL,” said
- Updates on Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor Vecabrutinib (SNS-062) in Adults with Chronic Lymphocytic Leukemia (CLL) and other B-Cell Malignancies. At an investor and analyst event held at the
American Society of Hematology Conferencein December 2017, Sunesis provided a program update on the ongoing Phase 1b/2 study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of its potent non-covalent BTK-inhibitor vecabrutinib in adults with CLL and other B cell malignancies. The Phase 1b/2 trial is an open-label, sequential-group study that is enrolling up to 124 patients who have progressed while on a covalent BTK inhibitor with the goal of determining the maximum tolerated and/or recommended phase 2 dose. We are updating guidance for this program, and now expect to reach a recommended phase 2 dose in the fall of 2018.
- Announced Nomination of PDK-1 Inhibitor SNS-510 as Development Candidate. In
November 2017, Sunesis announced that its PDK-1 inhibitor, SNS-510, was nominated as a Development Candidate and potentially first-to-clinic selective inhibitor in this pathway. 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.
- Changes in Executive Leadership and Board of Directors.
November 2017, Willie Quinnwas appointed Chief Financial Officer and Senior Vice President, Finance and Corporate Development. Prior to joining Sunesis, Willie was CEO and Co-Founder of the private cancer immunotherapy company Bullet Biotechnology. Prior to Bullet Bio, he led Corporate Development and Strategy at Jazz Pharmaceuticals.
March 2017, Judy Fox, Ph.D. rejoined Sunesis as Chief Scientific Officer. Judy previously served as a Vice President at Sunesis, and has over 25 years of experience with leadership roles at companies including Genentech and Chiron. Her career has focused on the translation of basic mechanistic understandings of promising drugs into coherent, evidence-based clinical development. Judy took over as program leader for vecabrutinib in July 2017.
January 2018, Daniel Swisherstepped down from his role as CEO to pursue another executive opportunity, and the Board of Directors appointed Dayton Misfeldt, a member of the Board since 2009, as Interim CEO, as well as formed a search committee to find a permanent CEO. The search for a permanent CEO is ongoing.
- Lastly, in
February 2018, H. Ward Wolffwas appointed to the Board of Directors. Ward brings over 40 years of finance and executive leadership experience to the Board, with 20 years of experience in the life sciences sector, most recently having served as Executive Vice President and Chief Financial Officer of Sangamo Therapeutics, Inc.Mr. Wolff is also designated chairman of the company’s Audit Committee.
- Cash, cash equivalents and marketable securities totaled
$31.8 millionas of December 31, 2017, as compared to $42.6 millionas of December 31, 2016. The decrease of $10.8 millionwas primarily due to $36.1 millionof net cash used in operating activities and a debt restructuring payment of $7.6 million, partially offset by $14.4 millionin net proceeds primarily from sales of common shares through the company’s at-the-market equity facility. An additional $18.5 millionin net proceeds were raised through a public offering in October 2017. This capital is expected to fund the company into 2019.
- Revenues for the year ended
December 31, 2017were $0.7 million, as compared to $2.5 millionfor 2016. The decrease between the periods was primarily due to deferred revenue recognized related to the Royalty Agreement with Royalty Pharma.
- Research and development expenses were
$3.7 millionand $21.5 millionfor the three months and year ended December 31, 2017, as compared to $4.8 millionand $22.9 millionfor the same periods in 2016, primarily relating to the SNS-062 and the vosaroxin development program in each period. The decrease of $1.4 millionin 2017 was primarily due to a decrease in professional services and $0.5 millionin salary and personnel costs partially offset by the $2.5 millionmilestone payment to Biogen under the license agreement.
- General and administrative expenses for the three months and year ended
December 31, 2017were $2.7 millionand $13.5 million, as compared to $3.9 millionand $16.1 millionfor the same periods in 2016. The decrease of $2.6 millionin 2017 was primarily due to decreases of $1.6 millionin salary and personnel costs, $0.8 millionin commercial expenses, and $0.3 millionin office and related expenses.
- Interest expense was
$0.3 millionand $1.4 millionfor the three months and year ended December 31, 2017, as compared to $0.5 millionand $1.7 millionfor the same periods in 2016. The decrease in the 2017 periods was primarily due to the decrease in the outstanding notes payable.
- Cash used in operating activities was
$36.1 millionfor the year ended December 31, 2017, as compared to $37.0 millionfor the same period in 2016. Net cash used in operating activities in 2017 resulted primarily from the net loss of $35.5 millionand changes in operating assets and liabilities of $4.0. million, offset by net adjustments for non-cash items of $3.3 million. Net cash used in operating activities in 2016 resulted primarily from the net loss of $38.0 million, offset by changes in operating assets and liabilities of $4.1 million.
- Sunesis reported loss from operations of
$6.4 millionand $34.4 millionfor the three months and year ended December 31, 2017, as compared to $8.1 millionand $36.5 millionfor the same periods in 2016. Net loss was $6.6 millionand $35.5 millionfor the three months and year ended December 31, 2017, as compared to $8.5 millionand $38.0 millionfor the same periods in 2016.
Conference Call Information
Sunesis will host a conference today at
Sunesis is a biopharmaceutical company developing new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built an experienced cancer 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 establishing proof of concept that its oral non-covalent BTK-inhibitor vecabrutinib, is effective in ibrutinib-resistant chronic lymphocytic leukemia. Vecabrutinib is currently being evaluated in a Phase 1b/2, open-label, sequential-group, dose-escalation and cohort-expansion study in adults with chronic lymphocytic leukemia and other B-cell malignancies who have progressed after prior therapies. Beyond the development of vecabrutinib, the Company has two other kinase inhibitor programs, including the Takeda-partnered pan-RAF inhibitor TAK-580, which is in solid tumor trials, and Sunesis’ proprietary preclinical PDK1 inhibitor SNS-510, which is in preclinical development with an IND submission planned in 2019. 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.
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. 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 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
CONSOLIDATED BALANCE SHEETS
|December 31,||December 31,|
|Cash and cash equivalents||$||26,977||$||8,056|
|Prepaids and other current assets||1,183||643|
|Total current assets||32,933||43,231|
|Property and equipment, net||20||3|
|Deposits and other assets||1,381|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||767||1,434|
|Other accrued liabilities||1,570||1,691|
|Current portion of deferred revenue||-||610|
|Current portion of notes payable||7,204||3,333|
|Total current liabilities||12,678||10,939|
|Non-current portion of notes payable||-||11,102|
|Other accrued liabilities||112||169|
|Additional paid-in capital||633,436||599,632|
|Accumulated other comprehensive income (loss)||(7||)||(22||)|
|Total stockholders’ equity||21,544||21,024|
|Total liabilities and stockholders’ equity||34,334||43,234|
Note 1: The consolidated balance sheet as of
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(In thousands, except per share amounts)
|Three months ended
|Twelve months ended
|License and other revenue||$||—||$||676||$||669||$||2,536|
|Research and development||3,674||4,815||21,540||22,881|
|General and administrative||2,760||3,934||13,548||16,115|
|Total operating expenses||6,434||8,749||35,088||38,996|
|Loss from operations||(6,434||)||(8,073||)||(34,419||)||(36,460||)|
|Other income (expense), net||91||10||357||158|
|Unrealized gain (loss) on available-for-sale securities||(6||)||(9||)||15||(11||)|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share||31,667||19,285||24,516||15,688|
|Basic and diluted loss per common share||$||(0.21||)||$||(0.44||)||$||(1.45||)||$||(2.42||)|
Note 2: The consolidated statement of operations and comprehensive loss for the year ended
|Investor and Media Inquiries:
|Maeve Conneighton||Willie Quinn|
|Argot Partners||Sunesis Pharmaceuticals Inc.|
Source: Sunesis Pharmaceuticals, Inc.