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Viracta(VIRX) - 2023 Q2 - Quarterly Report
2023-08-14 20:35
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 June 30, 2023 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 VIRACTA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 94-3295878 (State or other juri ...
Viracta(VIRX) - 2023 Q1 - Quarterly Report
2023-05-09 20:27
Clinical Trials and Product Development - Viracta's lead product candidate, Nana-val, is currently being investigated in multiple ongoing clinical trials, including a pivotal Phase 2 trial for relapsed/refractory EBV+ lymphoma[85]. - The NAVAL-1 trial aims to evaluate Nana-val's efficacy with a primary endpoint of objective response rate, targeting patients with relapsed or refractory disease after two or more prior therapies[86]. - The Phase 1b/2 trial for EBV+ recurrent or metastatic nasopharyngeal carcinoma has advanced to the fifth dose level, with no dose-limiting toxicities reported from the first four levels[90]. - The median duration of response for patients in the Phase 1b/2 trial of Nana-val was reported at 10.4 months, demonstrating promising activity in heavily pre-treated patients[88]. - Viracta anticipates providing an update on the first indication that may advance into Stage 2 of the NAVAL-1 trial in the first half of 2023[87]. - Viracta's development pipeline includes vecabrutinib and VRx-510, with ongoing evaluations for future development and collaboration opportunities[85]. Financial Performance and Expenses - General and administrative expenses are expected to increase as Viracta prepares for potential commercialization of Nana-val and continues to comply with SEC requirements[97]. - Research and development expenses primarily include clinical and regulatory-related costs, with significant expenditures related to the development of Nana-val[93]. - Research and development expenses for Q1 2023 increased by approximately $1.5 million to $7.6 million compared to $6.1 million in Q1 2022, primarily due to costs associated with clinical development programs[105]. - General and administrative expenses rose by approximately $0.3 million to $4.6 million in Q1 2023 from $4.3 million in Q1 2022, largely driven by personnel-related costs[106]. - As of March 31, 2023, the company reported an accumulated deficit of $227.1 million and expects to continue incurring net losses for several years[107]. Cash Flow and Funding - The company had cash, cash equivalents, and short-term investments totaling $80.3 million and working capital of $71.8 million as of March 31, 2023[108]. - Net cash used in operating activities was $11.3 million for Q1 2023, consistent with $11.4 million in Q1 2022[112]. - Net cash used in investing activities was $7.4 million in Q1 2023, reflecting the initiation of short-term investments, compared to no cash used in investing activities in Q1 2022[113]. - The company entered into a royalty purchase agreement with XOMA (US) LLC, receiving an upfront payment of $13.5 million and is eligible for up to $20.0 million in pre-commercialization milestones[117]. - Future funding requirements will depend on various factors, including the ability to raise additional funds, which may be impacted by global economic conditions and market volatility[115]. - The company has not sold any shares under its $50.0 million Open Market Sale Agreement during Q1 2023[109]. - The company anticipates ongoing expenses related to product development and commercialization activities in the near term[114]. Impact of External Factors - The company is actively monitoring the impact of global events, including the COVID-19 pandemic, on its business and clinical trial timelines[91].
Viracta(VIRX) - 2022 Q4 - Annual Report
2023-03-14 21:13
Financial Performance - The company incurred a net loss of approximately $35.5 million for the year ended December 31, 2022, compared to a net loss of $18.9 million for the year ended December 31, 2021 [513]. - As of December 31, 2022, the company had an accumulated deficit of approximately $214.9 million and expects to continue incurring net losses for at least the next several years [509]. - The company raised approximately $22.5 million from financing activities for the year ended December 31, 2022, compared to $62.4 million in 2021 [516]. - The company had cash, cash equivalents, and short-term investments of $91.0 million as of December 31, 2022, with working capital of $83.7 million [509]. - The company expects to incur additional expenses and increase operating losses for at least the next several years [512]. Research and Development - Research and development expenses for the year ended December 31, 2022, increased by approximately $2.4 million to $26.3 million compared to $23.9 million in 2021, primarily due to costs associated with clinical development programs [504]. - Viracta's lead product candidate, Nana-val, is currently being investigated in multiple clinical trials, including the NAVAL-1 trial for relapsed/refractory EBV+ lymphoma [484]. - The NAVAL-1 trial employs a Simon two-stage design, with the first stage focusing on a limited number of patients and potential expansion based on pre-specified activity thresholds [485]. - The median duration of response in the Phase 1b/2 trial for EBV+ R/R lymphoma was reported at 10.4 months, indicating promising activity [486]. - The Phase 1b/2 trial for EBV+ recurrent or metastatic nasopharyngeal carcinoma (NPC) is designed to evaluate the safety and efficacy of Nana-val, with the Phase 2 portion expected to initiate in the second half of 2023 [489]. - Viracta has received Fast Track Designation from the FDA for the treatment of R/R EBV+ lymphoid malignancies, along with orphan drug designations for several specific lymphoma types [487]. General and Administrative Expenses - General and administrative expenses rose to $24.3 million in 2022 from $15.4 million in 2021, reflecting an increase of $8.9 million [504]. - General and administrative expenses increased by approximately $8.9 million for the year ended December 31, 2022, largely due to non-cash share-based compensation [506]. - The company anticipates that general and administrative expenses will continue to increase as it prepares for potential commercialization of Nana-val [495]. Impact of COVID-19 - The COVID-19 pandemic has impacted clinical trial timelines and operations, with ongoing evaluations to mitigate these effects [490]. Investment Activities - Net cash used in investing activities was $53.9 million for the year ended December 31, 2022, primarily due to short-term investments initiated in June 2022 [515]. - The company received an upfront payment of $13.5 million from the Royalty Purchase Agreement with XOMA (US) LLC [507]. - The company has access to a $50.0 million credit facility, of which $20.0 million was drawn down as of December 29, 2022 [511]. Future Plans - The company plans to continue funding development activities and pre-commercialization activities for its lead product candidate [512].
Viracta(VIRX) - 2022 Q3 - Quarterly Report
2022-11-10 21:35
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 2022 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 VIRACTA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of inc ...
Viracta(VIRX) - 2022 Q2 - Quarterly Report
2022-08-09 20:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 June 30, 2022 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 VIRACTA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 94-3295878 (State or other juri ...
Viracta Therapeutics (VIRX) Investor Presentation - Slideshow
2022-06-11 19:45
viracta Viracta Therapeutics, Inc. June 2022 NASDAQ: VIRX \ WWW.VIRACTA.COM Precision Oncology for Virus-Associated Cancers Forward Looking Statements This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on current expectations, estimates and projections based on information currently available to management of Viracta Therapeutics, Inc. ("Viracta" or the "Company"), including, without limitation, statements rega ...
Viracta(VIRX) - 2022 Q1 - Quarterly Report
2022-05-10 20:41
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 March 31, 2022 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 VIRACTA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 94-3295878 (State or other jur ...
Viracta(VIRX) - 2021 Q4 - Annual Report
2022-03-16 23:21
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 VIRACTA THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 94-3295878 (State or other jurisdict ...
Viracta(VIRX) - 2021 Q3 - Quarterly Report
2021-11-10 21:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 2021 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 VIRACTA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 94-3295878 | | --- | - ...
Viracta(VIRX) - 2021 Q2 - Quarterly Report
2021-08-12 20:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 June 30, 2021 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 VIRACTA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 94-3295878 | | --- | --- | ...