VIRX Viracta Therapeutics Inc.

8.71
+0.19  (+2%)
Previous Close 8.52
Open 8.57
52 Week Low 7.2701
52 Week High 18.24
Market Cap $324,240,489
Shares 37,226,233
Float 37,134,723
Enterprise Value $205,718,505
Volume 279,281
Av. Daily Volume 143,320
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Upcoming Catalysts

Drug Stage Catalyst Date
Nanatinostat and valganciclovir (VT3996-201)
Epstein-Barr Virus Associated Lymphoma
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
Nanatinostat (NAVAL-1)
Epstein Barr Virus-associated cancers
Phase 2
Phase 2
Phase 3 trial commenced 2Q 2021.
Nanatinostat and valganciclovir and KEYTRUDA (pembrolizumab)
Nasopharyngeal carcinoma and Epstein-Barr Virus-Positive (EBV+) Solid Tumors
Phase 1/2
Phase 1/2
Phase 1b/2 trial to be initiated 2H 2021.

Latest News

  1. SAN DIEGO, Sept. 7, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc. (NASDAQ:VIRX), a precision oncology company targeting virus-associated malignancies, today announced that company management will present and be available for virtual one-on-one meetings at the H.C. Wainwright 23rd Annual Global Investment Conference, September 13 – 15, 2021, the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit, September 20 – 23, 2021, and the 2021 Cantor Virtual Global Healthcare Conference, September 27 – 30, 2021.

    Details on the presentations can be found below.

    H.C. Wainwright 23rd Annual Global Investment Conference

    Presentation Date:

    Corporate presentation will be available on-demand to conference
    registrants starting at 7:00 AM ET on September

    SAN DIEGO, Sept. 7, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc. (NASDAQ:VIRX), a precision oncology company targeting virus-associated malignancies, today announced that company management will present and be available for virtual one-on-one meetings at the H.C. Wainwright 23rd Annual Global Investment Conference, September 13 – 15, 2021, the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit, September 20 – 23, 2021, and the 2021 Cantor Virtual Global Healthcare Conference, September 27 – 30, 2021.

    Details on the presentations can be found below.

    H.C. Wainwright 23rd Annual Global Investment Conference

    Presentation Date:

    Corporate presentation will be available on-demand to conference

    registrants starting at 7:00 AM ET on September 13, 2021

     

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Presentation Date:

    September 21, 2021

    Presentation Time:

    4:35 PM ET

    Format:

    Corporate presentation

    Webcast Link:

    https://wsw.com/webcast/oppenheimer16/virx/2836187

     

    2021 Cantor Virtual Global Healthcare Conference

    Presentation Date:

    September 30, 2021

    Presentation Time:

    8:40 AM ET

    Format:

    Corporate presentation

    A replay of the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit presentation will be available on the "Events and Webcasts" section of the Viracta website at https://viracta.investorroom.com/events-and-webcasts.

    About Viracta Therapeutics, Inc.

    Viracta is a precision oncology company targeting virus-associated malignancies. Viracta's proprietary investigational drug, nanatinostat, is currently being evaluated in combination with the antiviral agent valganciclovir as an oral combination therapy in two Phase 2 clinical trials for EBV-positive lymphoma. Viracta is also pursuing application of its inducible synthetic lethality approach in other EBV-associated malignancies, such as nasopharyngeal carcinoma, gastric carcinoma, and other virus-related cancers.

    For additional information please visit www.viracta.com.

    Investor Relations Contact:                                     

    Company Contact:

    Joyce Allaire                                                               

    Dan Chevallard

    LifeSci Advisors                                                          

    Chief Operating Officer and Chief Financial Officer

    jallaire@lifesciadvisors.com                                     

    dchevallard@viracta.com 

    (212) 915-2569                                                          

    (858) 771-4193

     

    Viracta Therapeutics, Inc. Logo (PRNewsfoto/Viracta Therapeutics, Inc.)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/viracta-therapeutics-to-present-at-upcoming-investor-conferences-in-september-301370207.html

    SOURCE Viracta

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  2. SAN DIEGO, Aug. 23, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc. (NASDAQ:VIRX), a precision oncology company targeting virus-associated malignancies, today announced that it has reacquired the exclusive rights to develop and commercialize its all-oral combination product candidate in the People's Republic of China previously licensed to Shenzhen Salubris Pharmaceuticals Co., Ltd. (Salubris).  Pursuant to the mutual termination agreement between Viracta and Salubris, all development and commercialization rights under the license have been returned to Viracta in exchange for a $4.0 million cash payment to Salubris.

    "We thank the Salubris team for their support of Viracta and their collaborative contributions. As Viracta's strategic focus remains…

    SAN DIEGO, Aug. 23, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc. (NASDAQ:VIRX), a precision oncology company targeting virus-associated malignancies, today announced that it has reacquired the exclusive rights to develop and commercialize its all-oral combination product candidate in the People's Republic of China previously licensed to Shenzhen Salubris Pharmaceuticals Co., Ltd. (Salubris).  Pursuant to the mutual termination agreement between Viracta and Salubris, all development and commercialization rights under the license have been returned to Viracta in exchange for a $4.0 million cash payment to Salubris.

    "We thank the Salubris team for their support of Viracta and their collaborative contributions. As Viracta's strategic focus remains in precision oncology and Salubris focuses their development efforts on cardiovascular and related disease areas, we agreed the reversion of these rights to Viracta was in the best interest of patients," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "China represents an important geographical region for the treatment of patients with EBV-associated cancers. We believe regaining the development and commercial rights in China will enable Viracta to expand our global development strategy and has the potential to unlock significant, long-term and unencumbered value to our shareholders."

    Viracta's combination therapy of nanatinostat, its proprietary investigational drug, and valganciclovir is currently being evaluated in a global Phase 2 pivotal trial for the treatment of patients with Epstein-Barr virus-positive (EBV+) lymphoma. Viracta has also received United States Food and Drug Administration clearance of an Investigational New Drug application to proceed into a global Phase 1b/2 trial evaluating its combination therapy in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors. Initiation of this Phase 1b/2 trial is expected in the second half of 2021.

    About Nanatinostat

    Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in various subtypes of relapsed/refractory EBV+ lymphoma in multiple clinical trials, including a registration-enabling global, multicenter, open-label basket trial.

    About Viracta Therapeutics, Inc.

    Viracta is a precision oncology company targeting virus-associated malignancies. Viracta's proprietary investigational drug, nanatinostat, is currently being evaluated in combination with the antiviral agent valganciclovir as an oral combination therapy in two Phase 2 clinical trials for EBV-positive lymphoma. Viracta is also pursuing application of its inducible synthetic lethality approach in other EBV-associated malignancies, such as nasopharyngeal carcinoma, gastric carcinoma, and other virus-related cancers.

    For additional information please visit www.viracta.com.

    Forward-Looking Statements

    This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, the statement regarding Viracta's belief that regaining the development and commercial rights in China will enable Viracta to expand its global development strategy and has the potential to unlock significant, long-term and unencumbered value to its shareholders" and other statements that are not historical facts.  Risks and uncertainties related to Viracta that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Viracta's ability to successfully enroll patients in and complete its ongoing and planned clinical trials; Viracta's plans to develop and commercialize its product candidates, including all oral combinations of nanatinostat and valganciclovir; the timing of initiation of Viracta's planned clinical trials; the timing of the availability of data from Viracta's clinical trials; previous preclinical and clinical results may not be predictive of future clinical results; the timing of any planned investigational new drug application or new drug application; Viracta's plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Viracta's product candidates; Viracta's ability to manufacture or supplying nanatinostat, valganciclovir and pembrolizumab for clinical testing; Viracta's ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to Viracta's competitors and its industry; the impact of government laws and regulations; Viracta's ability to protect its intellectual property position; and Viracta's estimates regarding future expenses, capital requirements and need for additional financing in the future.

    These risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Viracta's reports and other documents that Viracta has filed, or will file, with the SEC from time to time and available at www.sec.gov.

    The forward-looking statements included in this communication are made only as of the date hereof. Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation.

    Investor Relations Contact:

    Joyce Allaire   

    LifeSci Advisors 

    jallaire@lifesciadvisors.com   

    (212) 915-2569                                

    Viracta Contact:

    Dan Chevallard

    Chief Operating Officer and Chief Financial Officer

    dchevallard@viracta.com

    (858) 771-4193

    Viracta Therapeutics, Inc. Logo (PRNewsfoto/Viracta Therapeutics, Inc.)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/viracta-therapeutics-reacquires-exclusive-development-and-commercialization-rights-for-its-all-oral-combination-therapy-in-china-301360519.html

    SOURCE Viracta

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  3. SAN DIEGO, Aug. 16, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc. (NASDAQ:VIRX), a precision oncology company targeting virus-associated malignancies, today announced the appointments of Flavia Borellini, Ph.D., and Jane F. Barlow, M.D., MPH, MBA, as independent members to Viracta's Board of Directors.

    "We are very pleased to welcome both Dr. Borellini and Dr. Barlow, two accomplished industry leaders with proven track records to the Viracta Board," said Roger J. Pomerantz, M.D., F.A.C.P., Chairman of the Board of Directors of Viracta. "Their collective experience in corporate strategy, oncology drug development and navigating the regulatory landscapes, in addition to their deep commercial and pricing experience, will be invaluable as we…

    SAN DIEGO, Aug. 16, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc. (NASDAQ:VIRX), a precision oncology company targeting virus-associated malignancies, today announced the appointments of Flavia Borellini, Ph.D., and Jane F. Barlow, M.D., MPH, MBA, as independent members to Viracta's Board of Directors.

    "We are very pleased to welcome both Dr. Borellini and Dr. Barlow, two accomplished industry leaders with proven track records to the Viracta Board," said Roger J. Pomerantz, M.D., F.A.C.P., Chairman of the Board of Directors of Viracta. "Their collective experience in corporate strategy, oncology drug development and navigating the regulatory landscapes, in addition to their deep commercial and pricing experience, will be invaluable as we position Viracta for long-term success in new oncology modalities. We look forward to their guidance and contributions to our future initiatives."  

    Dr. Borellini commented, "It is an honor to be a member of Viracta's Board. The Company has shown impressive clinical data and possesses a unique therapeutic approach with the potential to address unmet needs across multiple indications. I look forward to working with the fellow directors to provide valuable insights and counsel to the company's management team."

    Dr. Barlow added, "This is an exciting time for Viracta, and I am thrilled to be joining the Board. The company's EBV-positive lymphoma program has advanced into an innovative pivotal trial, while its solid tumor program is poised to enter the clinic later this year. It also has a strong financial foundation and the backing of a premier group of institutional and healthcare-focused investors, which I believe positions the company well for sustained success."  

    Appointee Bios

    Flavia Borellini, Ph.D., has more than 25 years of executive management experience in the pharmaceutical and biotechnology industry, with a particular focus on global development of targeted oncology drugs, from preclinical to commercial stage. She is the former Chief Executive Officer for Acerta Pharma, where she oversaw the successful development and approval of Calquence® (acalabrutinib), a selective Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia (CLL). During her career, Dr. Borellini has also held key senior level positions within AstraZeneca, most recently Global Franchise Head, Hematology, with responsibility for the hematology portfolio in the company's oncology business unit. While at AstraZeneca, she led the global development, approval, and commercialization of Tagrisso® (osimertinib), a first-in-class epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor for the treatment of non-small cell lung cancer (NSCLC) caused by the T790M mutation.

    Prior to her tenure with AstraZeneca, Dr. Borellini spent nearly seven years at Genentech, a member of the Roche Group. During this time, she led the global development, approval and launch of Zelboraf® (vemurafenib), a first-in-class BRAF inhibitor for the treatment of melanoma caused by the V600E BRAF mutation. Dr. Borellini also served as the program leader for Herceptin® (trastuzumab), a targeted treatment for HER2 receptor positive cancers, including breast cancer, and Tarceva® (erlotinib), an EGFR tyrosine kinase inhibitor for the treatment of NSCLC and pancreatic cancer.

    Dr. Borellini also serves on the Board of Directors of Kartos Therapeutics, Cantargia AP, and Revolution Medicines.

    Jane F. Barlow, M.D., MPH, MBA, is currently the Chief Executive Officer of Jane Barlow & Associates, LLC and a Board Director for ContraFect Corporation. She is Executive Vice President and Chief Clinical Officer at Real Endpoints, a market access consultancy, Senior Advisor to MIT's Center for Biomedical Innovation and serves on the biotech advisory board of Pictet Asset Management. Prior to her current roles, she was Associate Chief Medical Officer at CVS Health and Chief Medical Officer of CVS Health Government Services where she successfully implemented industry-leading clinical strategies supporting drug purchasing, distribution, and utilization management. Formerly, she served as Vice President of Clinical Innovation at Medco Health Solutions, leading the adoption of cutting-edge therapeutic programs through all aspects of pharmacy. Dr. Barlow has extensive experience in steering pharmaceutical development and commercialization by strategically weighing the value and economic impact that drug candidates bring to the healthcare ecosystem at large. Dr. Barlow previously served on the boards of Momenta Pharmaceuticals, Inc. (prior to and during its sale to Johnson and Johnson), TherapeuticsMD Inc., and SilverScript Insurance Company.

    Dr. Barlow received her medical degree from Creighton University School of Medicine and subsequently completed her residency in occupational and environmental medicine at The Johns Hopkins University, where she also earned her MPH She is a distinguished graduate of the United States Air Force School of Aerospace Medicine and served as Chief of Flight Medicine at the Beale and Maxwell Air Force Bases. Additionally, she holds an MBA from the University of Alabama. She is board-certified in occupational medicine and a fellow of the American College of Occupational and Environmental Medicine and the American College of Preventive Medicine. She is a diplomat of the American College of Physician Executives and a member of the American Medical Association.

    About Viracta Therapeutics, Inc.

    Viracta is a precision oncology company targeting virus-associated malignancies. Viracta's proprietary investigational drug, nanatinostat, is currently being evaluated in combination with the antiviral agent valganciclovir as an oral combination therapy in two Phase 2 clinical trials for EBV-positive lymphoma. Viracta is also pursuing application of its inducible synthetic lethality approach in other EBV-associated malignancies, such as nasopharyngeal carcinoma, gastric carcinoma, and other virus-related cancers.

    For additional information please visit www.viracta.com.

    Forward-Looking Statements

    This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding:  the significance of the Board of Director appointments and the expected contribution of the appointees; Viracta's clinical development plans; the potential of Viracta to address unmet needs across multiple indications; Viracta's ability to obtain and sustain success; and other statements that are not historical facts.  Risks and uncertainties related to Viracta that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Viracta's ability to successfully enroll patients in and complete its ongoing and planned clinical trials; Viracta's plans to develop and commercialize its product candidates, including all oral combinations of nanatinostat and valganciclovir; the timing of initiation of Viracta's planned clinical trials; the timing of the availability of data from Viracta's clinical trials; previous preclinical and clinical results may not be predictive of future clinical results; the timing of any planned investigational new drug application or new drug application; Viracta's plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Viracta's product candidates; Viracta's ability to manufacture or supplying nanatinostat, valganciclovir and pembrolizumab for clinical testing; Viracta's ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to Viracta's competitors and its industry; the impact of government laws and regulations; Viracta's ability to protect its intellectual property position; and Viracta's estimates regarding future expenses, capital requirements and need for additional financing in the future.

    These risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Viracta's reports and other documents that Viracta has filed, or will file, with the SEC from time to time and available at www.sec.gov.

    The forward-looking statements included in this communication are made only as of the date hereof. Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation.

     

    Investor Relations Contact:                        

    Viracta Contact:





    Joyce Allaire                               

    Dan Chevallard

    LifeSci Advisors                               

    Chief Operating Officer and Chief Financial Officer

    jallaire@lifesciadvisors.com                             

    dchevallard@viracta.com

    (212) 915-2569                                                

    (858) 771-4193

     

    Viracta Therapeutics, Inc. Logo (PRNewsfoto/Viracta Therapeutics, Inc.)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/viracta-therapeutics-announces-the-appointment-of-flavia-borellini-phd-and-jane-f-barlow-md-mph-mba-to-its-board-of-directors-301355525.html

    SOURCE Viracta

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  4. SAN DIEGO, Aug. 12, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc.  (NASDAQ:VIRX), a precision oncology company targeting virus-associated malignancies, today announced financial results for the second quarter of 2021 and provided clinical and corporate updates.

    "We entered the second half of the year with strong momentum thanks to the completion of key milestones across our pipeline," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "We believe Viracta is strongly-positioned to advance our novel therapy for the treatment of EBV-positive cancers forward, with our pivotal NAVAL-1 trial now open for enrollment and the recent clearance of our IND for EBV-positive solid tumors paving the way for a multicenter Phase 1b

    SAN DIEGO, Aug. 12, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc.  (NASDAQ:VIRX), a precision oncology company targeting virus-associated malignancies, today announced financial results for the second quarter of 2021 and provided clinical and corporate updates.

    "We entered the second half of the year with strong momentum thanks to the completion of key milestones across our pipeline," said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. "We believe Viracta is strongly-positioned to advance our novel therapy for the treatment of EBV-positive cancers forward, with our pivotal NAVAL-1 trial now open for enrollment and the recent clearance of our IND for EBV-positive solid tumors paving the way for a multicenter Phase 1b/2 trial.  These two trials are targeting patient populations with a significant unmet medical need, and our expansion into solid tumors could meaningfully broaden our addressable patient market."

    Second Quarter 2021 and Recent Highlights

    Clinical

    • NAVAL-1, a global pivotal trial in Epstein-Barr virus (EBV)-positive (EBV+) relapsed/refractory (R/R) lymphoma, now open for enrollment. NAVAL-1 (Nanatinostat in Combination with Valganciclovir) is a global, multicenter, open-label Phase 2 basket trial. The trial, which will include multiple subtypes of R/R EBV-positive (EBV+) lymphoma patients, is designed to evaluate the anti-tumor activity of the combination treatment of nanatinostat with valganciclovir and is anticipated to enroll up to approximately 140 patients. The primary endpoint of the trial is objective tumor response rate as assessed by an independent review committee. If successful, Viracta believes this trial could support multiple new drug application (NDA) filings across various EBV+ lymphoma subtypes.
    • Announced FDA clearance of IND application for a Phase 1b/2 trial in EBV+ solid tumors. The multicenter Phase 1b/2 trial is designed to evaluate the safety and preliminary efficacy of Viracta's all-oral combination regimen in patients with advanced EBV+ solid tumors, and in combination with the PD-1 inhibitor pembrolizumab in recurrent or metastatic nasopharyngeal carcinoma. Initiation of the trial is expected in the second half of 2021.

    Corporate

    • Strengthened company leadership with the appointment of Ayman Elguindy, Ph.D., as Chief Scientific Officer, and additional key additions to management team. Dr. Elguindy has over 23 years of experience studying the role of viruses in cancer and spent the last decade as a faculty member at the Yale University School of Medicine, most recently as an Associate Professor in the Department of Pediatrics, Section of Infectious Disease, and Department of Pathology. Viracta also recently appointed Patric Nelson, MBA, as Senior Vice President, Business Development and Corporate Strategy and Biljana Nadjsombati, Pharm.D., as Vice President, Pharmaceutical Development.
    • Added as a member of the Russell 2000® Index and other FTSE Russell indexes. In June 2021, Viracta was included as a member of the small-cap Russell 2000® Index, the all-cap Russell 3000® Index, and the Russell Microcap® Index.
    • Hosted key opinion leader webinar. The webinar featured presentations by key opinion leaders (KOLs) Pierluigi Porcu, M.D. (Thomas Jefferson University) and Kristen Cunanan, Ph.D. (Stanford Medicine Quantitative Sciences Unit) who discussed the current treatment landscape and unmet medical need in R/R EBV+ lymphoma, and the design of NAVAL-1. For a replay of the webinar, click here.

    Anticipated 2021 Milestones

    • Initiation of a global Phase 1b/2 clinical trial in EBV+ solid tumors: H2 2021
    • Updated data from Phase 1b/2 trial in R/R EBV+ lymphoma (VT3996-201): H2 2021

    Second Quarter 2021 Financial Results

    • Cash position – Cash and cash equivalents totaled approximately $122.7 million as of June 30, 2021. Viracta expects to end 2021 with greater than $100 million in cash and cash equivalents, which it expects will be sufficient to fund its operations into 2024.
    • Research and development expenses – Research and development expenses were $5.4 million and $9.5 million for the three and six-months ending June 30, 2021, respectively, compared to $3.4 million and $6.8 million for the same periods in 2020. This increase was primarily due to incremental costs associated with the initiation of the NAVAL-1 trial. 
    • General and administrative expenses – General and administrative expenses were $3.9 million and $7.7 million for the three and six-months ending June 30, 2021, respectively, compared to $0.9 million and $1.9 million for the same periods in 2020. This increase was primarily due to expenses associated with operating as a public company and non-recurring, costs related to the merger with Sunesis Pharmaceuticals, as well as non-cash share-based compensation. 
    • Acquired in-process research and development  Non-recurring, non-cash operating expenses of $0 and $84.5 million associated with the write-off of in-process research and development acquired in the merger were recorded for the three and six-months ending June 30, 2021.
    • Gain on Royalty Purchase Agreement  Gain on Royalty Purchase Agreement for the six-months ending June 30, 2021 was associated with upfront proceeds of $13.5 million received in connection with the multi-license milestone and royalty monetization transaction with XOMA Corporation in March 2021.
    • Adjusted loss from operations – Adjusted loss from operations for the six-months ended June 30, 2021, excluding the non-recurring and non-cash operating expenses associated with the write-off of in-process research and development acquired in the merger (a non-GAAP measure) was $3.7 million, compared to an unadjusted loss from operations of $88.2 million.  There is not a comparative adjustment to loss from operations for the same period in 2020.
    • Net loss – Net loss was $9.2 million, or $0.25 per share (basic and diluted) for the quarter ended June 30, 2021, compared to a net loss of $4.2 million, or $15.52 per share (basic and diluted), for the same period in 2020.  Net loss was $88.4 million, or $3.37 per share (basic and diluted) for the six months ended June 30, 2021, compared to a net loss of $8.7 million, or $32.13 per share (basic and diluted), for the same period in 2020.

    About Nanatinostat

    Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing latent viral genes which are epigenetically silenced in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in various subtypes of relapsed/refractory EBV+ lymphoma in multiple clinical trials, including a registration-enabling global, multicenter, open-label basket trial.

    About Viracta Therapeutics, Inc.

    Viracta is a precision oncology company targeting virus-associated malignancies. Viracta's proprietary investigational drug, nanatinostat, is currently being evaluated in combination with the antiviral agent valganciclovir as an oral combination therapy for EBV+ lymphoma. Viracta is also pursuing application of its inducible synthetic lethality approach in other EBV-associated malignancies, such as nasopharyngeal carcinoma, gastric carcinoma, and other virus-related cancers.

    For additional information please visit www.viracta.com.

    Forward-Looking Statements

    This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the details and timeline for the ongoing and planned trials; the ability of Viracta to support multiple NDA filings from the NAVAL-1 trial; Viracta's ability to expand the impact and broaden the reach of its therapeutic approach, the timing of the initiation of the solid tumor trial and the updated date from the ongoing Phase 1b/2 trial; Viracta's cash projections and the sufficiency its cash and cash equivalents to fund operations into 2024; and other statements that are not historical facts.  Risks and uncertainties related to Viracta that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Viracta's ability to successfully enroll patients in and complete its ongoing and planned clinical trials; Viracta's plans to develop and commercialize its product candidates, including all oral combinations of nanatinostat and valganciclovir; the timing of initiation of Viracta's planned clinical trials; the timing of the availability of data from Viracta's clinical trials; previous preclinical and clinical results may not be predictive of future clinical results; the timing of any planned investigational new drug application or new drug application; Viracta's plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Viracta's product candidates; Viracta's ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to Viracta's competitors and its industry; the impact of government laws and regulations; Viracta's ability to protect its intellectual property position; and Viracta's estimates regarding future expenses, capital requirements and need for additional financing in the future.

    These risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Viracta's reports and other documents that Viracta has filed, or will file, with the SEC from time to time and available at www.sec.gov.

    The forward-looking statements included in this communication are made only as of the date hereof. Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation.

    Investor Relations Contact:

    Company Contact:





    Joyce Allaire

    Dan Chevallard

    LifeSci Advisors

    Chief Operating Officer and Chief Financial Officer

    jallaire@lifesciadvisors.com 

    dchevallard@viracta.com   

    (212) 915-2569

    (858) 771-4193

     

    Viracta Therapeutics, Inc.













    Selected Balance Sheet Highlights













    (in thousands)

















    June 30,





    December 31,

















    2021





    2020

















    (Unaudited)











































    Cash and cash equivalents

    $

    122,721



    $

    47,089













    Total assets

    $

    128,679



    $

    48,305













    Total liabilities

    $

    11,582



    $

    11,203













    Stockholders' equity

    $

    117,097



    $

    (46,200)





































    Viracta Therapeutics, Inc.













    Condensed Consolidated Statement of Operations and Comprehensive Loss













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    (Unaudited)

















    Three Months Ended





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    June 30, 





    June 30, 





    2021





    2020





    2021





    2020

    Operating expenses:























    Research and development

    $

    5,446



    $

    3,361



    $

    9,470



    $

    6,807

    Acquired in-process research and development



    -





    -





    84,478





    -

    General and administrative



    3,871





    879





    7,711





    1,890

    Total operating expenses



    9,317





    4,240





    101,659





    8,697

    Gain on Royalty Purchase Agreement



    -





    -





    13,500





    -

    Loss from operations



    (9,317)





    (4,240)





    (88,159)





    (8,697)

    Total other income (expense)



    147





    4





    (242)





    44

    Net loss and comprehensive loss

    $

    (9,170)



    $

    (4,236)



    $

    (88,401)



    $

    (8,653)

    Net loss per share, basic and diluted

    $

    (0.25)



    $

    (15.52)



    $

    (3.37)



    $

    (32.13)

    Weighted-average common shares

    outstanding, basic and diluted

    37,221,407



    273,056



    26,255,992



    269,325

























    Viracta Therapeutics, Inc.













    Reconciliation of GAAP Loss from Operations to Adjusted Loss from Operations













    (in thousands)













    (Unaudited)

















    Three Months Ended





    Six Months Ended





    June 30, 





    June 30, 





    2021





    2020





    2021





    2020

    Loss from operations

    $

    (9,317)



    $

    (4,240)



    $

    (88,159)



    $

    (8,697)

    Less: Acquired in-process research and development



    -





    -





    84,478





    -

    Adjusted loss from operations

    $

    (9,317)



    $

    (4,240)



    $

    (3,681)



    $

    (8,697)

     

    Viracta Therapeutics, Inc. Logo (PRNewsfoto/Viracta Therapeutics, Inc.)

     

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    SOURCE Viracta

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  5. SAN DIEGO, July 21, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc. (NASDAQ:VIRX), a precision oncology company targeting virus-associated malignancies, today announced that the U.S. Food and Drug Administration (FDA) has cleared Viracta's Investigational New Drug (IND) application to proceed into a Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid tumors. The global Phase 1b/2 trial is designed to evaluate the safety and preliminary efficacy of Viracta's all-oral combination regimen in advanced EBV+ solid tumors (including EBV+ RM-NPC), and in combination with the PD-1 inhibitor pembrolizumab in EBV+ RM-NPC. Initiation of the trial is expected in the second half of 2021.

    "Clearance…

    SAN DIEGO, July 21, 2021 /PRNewswire/ -- Viracta Therapeutics, Inc. (NASDAQ:VIRX), a precision oncology company targeting virus-associated malignancies, today announced that the U.S. Food and Drug Administration (FDA) has cleared Viracta's Investigational New Drug (IND) application to proceed into a Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid tumors. The global Phase 1b/2 trial is designed to evaluate the safety and preliminary efficacy of Viracta's all-oral combination regimen in advanced EBV+ solid tumors (including EBV+ RM-NPC), and in combination with the PD-1 inhibitor pembrolizumab in EBV+ RM-NPC. Initiation of the trial is expected in the second half of 2021.

    "Clearance of this IND application is a crucial milestone that underscores the broader applicability of our therapeutic approach to treating patients with EBV-associated malignancies," said Lisa Rojkjaer, M.D., Chief Medical Officer of Viracta. "EBV is the primary etiologic agent for NPC, one of the most commonly reported head and neck cancers worldwide. Patients with RM-NPC have a poor prognosis, with no standard treatment options for second or later lines of therapy, and median overall survival of less than 20 months. PD-L1 is known to be highly expressed by NPC and preliminary response rates of 20%-30% have been reported with PD-1 inhibitors for RM-NPC. Given the encouraging activity seen in our Phase 1b/2 trial of nanatinostat and valganciclovir in patients with EBV+ recurrent lymphomas, we now turn to evaluating this combination in patients with other EBV+ malignancies and explore potential synergies with checkpoint inhibition."

    Ivor Royston, M.D., President and Chief Executive Officer of Viracta, added, "Expansion into our solid tumor program is an important component of our clinical and corporate strategy, and one that could significantly expand our addressable patient population and unlock significant value to shareholders. Our all-oral combination regimen represents a promising new therapeutic approach to patients with EBV+ solid tumors, and I'm very pleased that the program is progressing as planned and look forward to its continued advancement."

    The Phase 1b dose escalation portion of the trial is designed to evaluate safety, pharmacokinetics, and determine the recommended Phase 2 dosing regimen of nanatinostat and valganciclovir for expansion in patients with EBV+ solid tumors. In Phase 2, the safety, preliminary efficacy and potential pharmacodynamic markers of nanatinostat and valganciclovir together and in combination with pembrolizumab will be evaluated in EBV+ RM-NPC patients.  

    About Nanatinostat

    Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in multiple subtypes of relapsed/refractory EBV+ lymphoma in two ongoing Phase 2 trials, one of which is a registration-enabling global, multicenter, open-label basket trial.

    About Viracta Therapeutics, Inc.

    Viracta is a precision oncology company targeting virus-associated malignancies. Viracta's proprietary investigational drug, nanatinostat, is currently being evaluated in combination with the antiviral agent valganciclovir as an oral combination therapy in two Phase 2 clinical trials for EBV-positive lymphoma. Viracta is also pursuing application of its inducible synthetic lethality approach in other EBV-associated malignancies, such as nasopharyngeal carcinoma, gastric carcinoma, and other virus-related cancers.

    For additional information please visit www.viracta.com.

    Forward-Looking Statements

    This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding:  the initiation, details and timeline for the Phase 1b/2 solid tumor trial and related expectations; Viracta's ability to expand its pipeline and broaden the impact of its therapeutic approach; the potential synergistic interactions between Viracta's product candidate and pembrolizumab; Viracta's ability to increase shareholder value; and other statements that are not historical facts.  Risks and uncertainties related to Viracta that may cause actual results to differ materially from those expressed or implied in any forward-looking statement include, but are not limited to: Viracta's ability to successfully enroll patients in and complete its ongoing and planned clinical trials; Viracta's plans to develop and commercialize its product candidates, including all oral combinations of nanatinostat and valganciclovir; the timing of initiation of Viracta's planned clinical trials; the timing of the availability of data from Viracta's clinical trials; previous preclinical and clinical results may not be predictive of future clinical results; the timing of any planned investigational new drug application or new drug application; Viracta's plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Viracta's product candidates; Viracta's ability to manufacture or supplying nanatinostat, valganciclovir and pembrolizumab for clinical testing; Viracta's ability to identify additional products or product candidates with significant commercial potential; developments and projections relating to Viracta's competitors and its industry; the impact of government laws and regulations; Viracta's ability to protect its intellectual property position; and Viracta's estimates regarding future expenses, capital requirements and need for additional financing in the future.

    These risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" and elsewhere in Viracta's reports and other documents that Viracta has filed, or will file, with the SEC from time to time and available at www.sec.gov.

    The forward-looking statements included in this communication are made only as of the date hereof. Viracta assumes no obligation and does not intend to update these forward-looking statements, except as required by law or applicable regulation.

    Investor Relations Contact:                                  

    Joyce Allaire                                                               

    LifeSci Advisors                                                         

    jallaire@lifesciadvisors.com                                     

    (212) 915-2569                                                          

    Viracta Contact:

    Dan Chevallard

    Chief Operating Officer and Chief Financial Officer

    dchevallard@viracta.com

    (858) 771-4193

    Viracta Therapeutics, Inc. Logo (PRNewsfoto/Viracta Therapeutics, Inc.)

     

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    SOURCE Viracta Therapeutics, Inc.

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