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Last10K.com | 10-K Annual Report Thu Mar 07 2019
Exhibit 99.1
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Investor and Media Inquiries: Maeve Conneighton Argot Partners 212-600-1902 |
Willie Quinn Sunesis Pharmaceuticals Inc. 650-266-3716 |
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Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2018 Financial Results and Recent Highlights
Sunesis to Host Conference Call Today at 4:30 PM Eastern Time
SOUTH SAN FRANCISCO, Calif., March 7, 2019
-- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for the fourth quarter and year ended December 31, 2018. Loss from operations for the three months and year ended December 31, 2018 was $5.8 million and $25.7 million. As of December 31, 2018, cash and cash equivalents totaled $13.7 million. Subsequent to the end of the quarter, the company raised $20 million in gross proceeds from concurrent underwritten public offerings in January.“We began 2019 by announcing the move into the 100 mg cohort for our Phase 1b/2 trial of vecabrutinib, an important milestone as we continue to believe that 100 – 300 mg will be the potentially therapeutic dose levels,” said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. “To date, we have seen an encouraging safety profile, evidence of pharmacodynamic activity and some improvements in clinical symptoms in CLL and other B cell cancer patients both with and without BTK C481 mutations. We are targeting an update on our ongoing vecabrutinib trial at the European Hematology Association Congress (EHA) in June 2019. In addition, in January, we completed an equity offering with leading biotechnology investors that extends our runway through important clinical milestones.”
Recent Highlights
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Announced Advancement into 100mg Cohort. In January 2019, the Company announced that it had opened the 100 mg cohort in the Phase 1b/2 trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies. |
The latest protocol amendment, approved by most sites in February 2019, allows for upfront enrollment of up to 6 evaluable patients into a cohort, and we have taken advantage of this to allocate additional slots for the 100mg cohort. By studying more patients and collecting more data, we can better characterize vecabrutinib’s profile at this dose level.
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Completion of $20 million Financing. In January, Sunesis announced the completion of an equity financing with net proceeds of approximately $18.4 million. The financing attracted participation from leading biotechnology investors and will allow Sunesis to advance vecabrutinib through important clinical milestones as we explore the potentially active dose levels. |
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Presentation of Preliminary Data at the ASH Annual Meeting. In December 2018, Sunesis presented preliminary data from the Phase 1b/2 clinical trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies. |
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The following information was filed by Sunesis Pharmaceuticals Inc (SNSS) on Thursday, March 7, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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Sunesis Pharmaceuticals Inc's Definitive Proxy Statement (Form DEF 14A) filed after their 2019 10-K Annual Report includes:
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Financial - Expense Highlight
Research and development expense consists primarily of clinical trial costs, which include: payments for work performed by our contract research organizations, clinical trial sites, labs and other clinical service providers and for drug packaging, storage and distribution; drug manufacturing costs, which include costs for producing drug substance and drug product, and for stability and other testing; personnel costs, including non-cash stock-based compensation; other outside services and consulting costs; and payments under license agreements.
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Revenue - Product Highlight
In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under these agreements, we perform the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each performance obligation.
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Financial - Shares Highlight
Upon execution of the CSPA, we sold to Aspire 228,311 shares of common stock at a price of $2.19 per share, for total proceeds of $0.5 million.
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Financial - Expense Highlight
General and administrative expense consists primarily of personnel costs for the related employees, including non-cash stock-based compensation; outside service costs, including fees paid to external legal advisors, marketing consultants and our independent registered public accounting firm; facilities expenses; and other administrative costs.
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Financial - Expense Highlight
Costs incurred for setting up clinical trial sites for participation in trials are generally non-refundable, and are expensed as incurred, with any refundable advances related to enrollment of the first patient recorded as prepayments and assessed for recoverability on a quarterly basis.
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Under the CSPA, on any...Read more
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During 2018, we sold an...Read more
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Other - Other
Although we believe that the...Read more
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Other - Other
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We shall also have the...Read more
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The most recent amendment to...Read more
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Other - Other
Net cash provided in both...Read more
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Financial - Expense
The decrease of $2.2 million...Read more
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Other - Other
The Amendments modified the loan...Read more
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Financial Statements, Disclosures and Schedules
Inside this 10-K Annual Report
Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Operations And Comprehensive Loss
Consolidated Statements Of Stockholders' Equity
Consolidated Statements Of Stockholders' Equity (Parenthetical)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Detail)
Commitments And Contingencies - Aggregate Non-Cancelable Future Minimum Rental Payments Under Operating Leases (Detail)
Company Overview
Company Overview - Additional Information (Detail)
Financial Instruments
Financial Instruments (Tables)
Financial Instruments - Additional Information (Detail)
Financial Instruments - Fair Value Of Company's Financial Assets Measured On Recurring Basis (Detail)
Guarantees And Indemnification
Guarantees And Indemnification - Additional Information (Detail)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Detail)
Income Taxes - Income Tax Provision Amount Computed By Applying Statutory Income Tax Rate (Detail)
Income Taxes - Loss Before Provision For Income Taxes (Detail)
Income Taxes - Reconciliation Of Unrecognized Tax Benefits (Detail)
Income Taxes - Significant Components Of Deferred Tax Assets (Detail)
License Agreements
License Agreements - Additional Information (Detail)
Loss Per Common Share
Loss Per Common Share (Tables)
Loss Per Common Share - Computation Of Basic And Diluted Loss Per Common Share (Detail)
Loss Per Common Share - Schedule Of Potential Common Shares Issuable Pursuant To Outstanding Securities Excluded From Computation Of Diluted Loss Per Common Share (Detail)
Notes Payable
Notes Payable (Tables)
Notes Payable - Additional Information (Detail)
Notes Payable - Summary Of Future Minimum Payments Under Loan Facility (Detail)
Other Accrued Liabilities
Other Accrued Liabilities (Tables)
Other Accrued Liabilities - Summary Of Other Accrued Liabilities (Detail)
Royalty Agreement
Royalty Agreement - Additional Information (Detail)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Detail)
Stock-Based Compensation - Summary Of Stock Option Activity For Company's Stock Option Plans (Detail)
Stock-Based Compensation - Summary Of Stock-Based Compensation Expense Related To Company's Stock-Based Awards (Detail)
Stock-Based Compensation - Summary Of Weighted-Average And Total Estimated Grant Date Fair Values Of Employee Stock Options Granted (Detail)
Stockholders' Equity
Stockholders' Equity (Tables)
Stockholders' Equity - Additional Information 1 (Detail)
Stockholders' Equity - Additional Information 2 (Detail)
Stockholders' Equity - Additional Information 3 (Detail)
Stockholders' Equity - Additional Information 4 (Detail)
Stockholders' Equity - Schedule Of Warrants To Purchase Shares Of Company's Common Stock (Detail)
Stockholders' Equity - Shares Of Common Stock Reserved For Future Issuance (Detail)
Subsequent Events
Subsequent Events - Additional Information (Detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies - Additional Information (Detail)
Material Contracts, Statements, Certifications & more
Sunesis Pharmaceuticals Inc provided additional information to their SEC Filing as exhibits
Ticker: SNSS
CIK: 1061027
Form Type: 10-K Annual Report
Accession Number: 0001564590-19-006828
Submitted to the SEC: Thu Mar 07 2019 12:00:29 PM EST
Accepted by the SEC: Thu Mar 07 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations
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