Workflow
Viracta(VIRX)
icon
Search documents
Sunesis Pharmaceuticals (SNSS) Investor Presentation - Slideshow
2019-12-11 17:28
Pharmaceuticals, Inc. Corporate Overview December 2019 Inspired to Make a Difference for Cancer Patients Safe Harbor Statement This presentation contains forward-looking statements, including statements related to the continued development of vecabrutinib (SNS-062) and other product candidates, including the timing and preliminary results of Phase 1b/2 trial of vecabrutinib and the therapeutic potential of vecabrutinib, further development and potential of its kinase inhibitor pipeline, planned development ...
Viracta(VIRX) - 2019 Q3 - Earnings Call Transcript
2019-11-13 03:34
Financial Data and Key Metrics Changes - The company reported a loss for operations of $6.0 million for Q3 2019, with total cash used in operating activities amounting to $18.4 million for the nine months ended September 30, 2019, compared to $17.9 million for the same period in 2018 [25]. - The cash position at the end of the quarter was $38.3 million, a significant increase from $13.7 million as of December 31, 2018, primarily due to $45.1 million in net proceeds from issuing common and preferred stock [26]. Business Line Data and Key Metrics Changes - The lead asset, vecabrutinib, is currently in the dose escalation phase of a Phase 1b/2 trial, with over 30 patients treated and strong enrollment in the study [8][9]. - The company is also advancing its proprietary PDK1 inhibitor, SNS-510, with preclinical data showing promising activity in hematologic and solid tumor cancer models [12]. Market Data and Key Metrics Changes - The company is preparing for a clinical update and poster presentation at the American Society of Hematology meeting in December, which will provide further insights into the ongoing trials [10]. Company Strategy and Development Direction - The company aims to identify the recommended Phase 2 dose for vecabrutinib to begin testing in defined patient populations, particularly those resistant to covalent BTK inhibitors [9][16]. - SNS-510 is positioned as a first-in-class compound, with plans to file an IND by the end of 2020, indicating a strong pipeline development strategy [12][22]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of vecabrutinib to address unmet needs in patients with hematologic malignancies who have developed resistance to existing treatments [7][16]. - The company highlighted a strong cash position that will support the advancement of its clinical programs through important milestones [13][26]. Other Important Information - The company recently appointed Dr. Nicole Onetto to its Board of Directors, bringing over 20 years of clinical development experience in oncology and hematology [15]. Q&A Session Summary Question: Relationship between dose and drug plasma concentration levels - Management indicated that they are encouraged by the increase in exposure seen with dose escalation and will provide more details at the upcoming ASH meeting [29]. Question: Patient enrollment status - The company noted a mix of patients, with some being less heavily pretreated as they move to higher doses [33]. Question: Efficacy exposure levels - Management is continuing to understand the relationship between dose exposure and efficacy as they progress through dose escalation [37]. Question: Decision process for dose escalation or expansion - The decision to escalate or expand will depend on composite data from safety and activity information at the time of evaluation [39].
Viracta(VIRX) - 2019 Q3 - Quarterly Report
2019-11-12 21:44
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-51531 SUNESIS PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 94-3295878 (State or Ot ...
Viracta(VIRX) - 2019 Q2 - Earnings Call Transcript
2019-08-08 01:05
Sunesis Pharmaceuticals, Inc. (SNSS) Q2 2019 Earnings Conference Call August 7, 2019 4:30 PM ET Company Participants Willie Quinn - Chief Financial Officer & Senior Vice President, Corporate Development Dayton Misfeldt - Interim Chief Executive Officer Judy Fox - Chief Scientific Officer Par Hyare - Senior Vice President Commercial Deepali Suri - Vice President, Clinical Operations Conference Call Participants Marc Frahm - Colin Hartaj Singh - Oppenheimer Jim Birchenough - Wells Fargo Securities Yanan Zhu - ...
Viracta(VIRX) - 2019 Q2 - Quarterly Report
2019-08-07 20:32
FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Registrant's Telephone Number, Including Area Code) Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading Symbol | Na ...
Viracta(VIRX) - 2018 Q1 - Earnings Call Transcript
2019-05-08 22:54
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) Q1 2019 Earnings Conference Call May 8, 2019 4:30 PM ET Company Participants Willie Quinn - Chief Financial Officer & Senior Vice President, Corporate Development Dayton Misfeldt - Interim Chief Executive Officer Judy Fox - Chief Scientific Officer Deepali Suri - Vice President, Clinical Operations Conference Call Participants Marc Frahm - Cowen and Company Hartaj Singh - Oppenheimer Operator Good afternoon, ladies and gentlemen and welcome to the Q1 2019 Sunesis ...
Viracta(VIRX) - 2019 Q1 - Quarterly Report
2019-05-08 20:55
Part I. Financial Information [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company reported an improved net loss of $5.9 million in Q1 2019, driven by decreased operating expenses, and significantly strengthened its cash position to $24.8 million from financing activities, despite ongoing going concern doubts [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $27.8 million by March 31, 2019, driven by a rise in cash to $24.8 million, while total stockholders' equity significantly grew to $17.1 million due to financing activities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $24,811 | $13,696 | | Total current assets | $26,410 | $15,200 | | Total assets | $27,754 | $15,324 | | **Liabilities & Equity** | | | | Total current liabilities | $9,975 | $11,323 | | Total liabilities | $10,668 | $11,331 | | Total stockholders' equity | $17,086 | $3,993 | | Total liabilities and stockholders' equity | $27,754 | $15,324 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2019 saw no revenue, but operating expenses decreased to $5.7 million, resulting in an improved net loss of $5.9 million or ($0.10) per share compared to Q1 2018 Q1 2019 vs. Q1 2018 Statement of Operations (in thousands, except per share data) | Metric | Q1 2019 | Q1 2018 | | :--- | :--- | :--- | | Total revenues | $0 | $237 | | Research and development | $3,248 | $3,969 | | General and administrative | $2,439 | $3,359 | | Total operating expenses | $5,687 | $7,328 | | Loss from operations | ($5,687) | ($7,091) | | Net loss | ($5,860) | ($7,273) | | Net loss per common share | ($0.10) | ($0.21) | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $6.1 million, offset by $17.2 million from financing activities, leading to an $11.1 million net increase in cash, bringing the quarter-end balance to $24.8 million Q1 2019 vs. Q1 2018 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2019 | Q1 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($6,113) | ($6,550) | | Net cash provided by investing activities | $0 | $742 | | Net cash provided by financing activities | $17,228 | $196 | | **Net increase (decrease) in cash** | **$11,115** | **($5,612)** | | **Cash at end of period** | **$24,811** | **$21,365** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's cancer inhibitor development, disclose substantial doubt about its going concern ability due to insufficient cash, and highlight recent financing activities including a $18.6 million public offering and a $5.5 million debt refinancing - The company is a biopharmaceutical firm focused on developing targeted inhibitors for cancer, with its lead program being **vecabrutinib**, a **BTK inhibitor** for B-cell malignancies[17](index=17&type=chunk)[18](index=18&type=chunk) - There is **substantial doubt** about the company's ability to continue as a **going concern**, as its cash and cash equivalents of **$24.8 million** are not sufficient to support operations for the next twelve months. The company will require additional financing to continue[21](index=21&type=chunk)[23](index=23&type=chunk) - In January 2019, the company raised approximately **$18.6 million** in net proceeds from underwritten public offerings of common stock and Series E Convertible Preferred Stock[53](index=53&type=chunk) - In April 2019, the company entered into a new **$5.5 million** term loan agreement with Silicon Valley Bank (SVB) and used the proceeds to repay its existing **$5.9 million** debt obligation[52](index=52&type=chunk)[62](index=62&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the kinase inhibitor pipeline, reiterates substantial doubt about going concern due to insufficient cash, attributes reduced net loss to lower operating expenses, and explains the cash increase from a $18.6 million public offering - The company's lead program is **vecabrutinib**, a non-covalent **BTK inhibitor** being studied in a Phase 1b/2 trial for advanced B-cell malignancies. The company is also developing **SNS-510**, a **PDK1 inhibitor**[71](index=71&type=chunk)[72](index=72&type=chunk) - Management explicitly states that current cash and cash equivalents are not sufficient to support operations for twelve months, which raises **substantial doubt** about the company's ability to continue as a **going concern**. Additional financing is required[80](index=80&type=chunk)[97](index=97&type=chunk) Comparison of Operating Expenses (in millions) | Expense Category | Q1 2019 | Q1 2018 | Change | | :--- | :--- | :--- | :--- | | Research and Development | $3.2 | $4.0 | ($0.8) | | General and Administrative | $2.4 | $3.4 | ($1.0) | - The **$11.1 million** increase in cash during the quarter was primarily due to **$18.6 million** in net proceeds from stock offerings, offset by **$6.1 million** used in operations and a **$1.4 million** principal payment on debt[100](index=100&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk - As a **smaller reporting company** defined by Rule 12b-2 of the Securities Exchange Act of 1934, the company is not required to provide quantitative and qualitative disclosures about market risk[113](index=113&type=chunk) [Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2019, with no material changes in internal control over financial reporting during the quarter - The company's management concluded that **disclosure controls and procedures were effective** at a reasonable assurance level as of the end of the quarter[115](index=115&type=chunk) - No changes occurred in the company's **internal control over financial reporting** during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[116](index=116&type=chunk) Part II. Other Information [Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect on its financial condition or operations - The company believes there is **no pending litigation** that could, individually or in the aggregate, have a **material adverse effect** on its results of operations or financial condition[120](index=120&type=chunk) [Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including financial viability, the need for substantial additional capital, substantial doubt about its going concern ability, potential clinical trial failures, reliance on third-party manufacturers, competition, intellectual property, and Nasdaq delisting risk - The company needs to raise **substantial additional funding** to continue its development programs and there is **substantial doubt** about its ability to continue as a **going concern**[123](index=123&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) - The development of key product candidates like **vecabrutinib** and **SNS-510** could be halted or significantly delayed due to clinical trial failures, safety issues, or patient enrollment difficulties[130](index=130&type=chunk)[138](index=138&type=chunk) - The company relies on a limited number of **third-party contract manufacturers** for its Active Pharmaceutical Ingredient (API) and Finished Drug Product (FDP), and any failure by these suppliers could halt development[133](index=133&type=chunk) - The company's common stock is at risk of **delisting from The Nasdaq Capital Market** if it fails to meet continued listing requirements, such as the minimum bid price. The company regained compliance in April 2019 but could fall out of compliance again[200](index=200&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the period - **None**[211](index=211&type=chunk) [Defaults Upon Senior Securities](index=39&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the period - **None**[212](index=212&type=chunk) [Mine Safety Disclosures](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - **Not applicable**[213](index=213&type=chunk) [Other Information](index=39&type=section&id=Item%205.%20Other%20Information) No other information to report for the period - **None**[214](index=214&type=chunk) [Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, the new term loan agreement, and officer certifications - A list of exhibits filed with the report is provided, including certifications by the CEO and CFO, and the **Term Loan Agreement with Silicon Valley Bank** dated April 26, 2019[215](index=215&type=chunk)[217](index=217&type=chunk)
Viracta(VIRX) - 2018 Q4 - Annual Report
2019-03-07 22:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Year Ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 000-51531 SUNESIS PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 395 Oyster Point Boulevard, Sui ...