Immunoblastic Lymphadenopathy

- Reported combined Stage 1 and Stage 2 results from the relapsed or refractory EBV-positive peripheral T-cell lymphoma (PTCL) cohort of the Phase 2 NAVAL-1 trial demonstrating Nana-val’s substantial antitumor activity and generally well-tolerated safety profile - - New positive data and productive feedback from the FDA support updated Nana-val clinical development plan in EBV-positive PTCL patients; randomized controlled trial planned to begin in the second half of 2025 to support potential registration - - Appointed Michael Faerm as Chief Financial Officer - SAN DIEGO, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today reported financial results for the second quarter of 2024 and provided a business update. “In the second quarter, we took several important steps to drive forward our clinical development program for Nana-val, our first-in-class, all-oral combination treatment regimen for Epstein-Barr virus (EBV) associated cancers,” said Mark Rothera, President and Chief Executive Officer of Viracta. “We received productive feedback from our meeting with the FDA and are encouraged by additional positive data from the ongoing NAVAL-1 trial, particularly in the second-line EBV-positive PTCL subgroup. To optimize the clinical benefit of Nana-val, we plan to focus on the second-line EBV-positive PTCL subpopulation in the NAVAL-1 trial’s expansion phase and initiate a randomized controlled trial in 2025 to potentially support registration. We believe our sharpened focus on the EBV-positive lymphoma program will propel us forward to key milestones and support our speed to market strategy. We look forward to providing more updates on our progress.” Clinical Trial Updates and Anticipated Milestones Phase 2 NAVAL-1 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma Clinical Trial Updates: Announced positive combined Stage 1 and Stage 2 data (n=21) in the R/R EBV+ PTCL cohort of patients treated with nanatinostat (20 mg orally once daily, 4 days/week) in combination with valganciclovir (900 mg orally once daily, 7 days/week) across the first two stages of the study. As of the June 28, 2024 data cutoff, combined Stages 1 and 2 data demonstrated Nana-val’s substantial antitumor activity and generally well-tolerated safety profile with a median duration of response (DOR) that has not yet been reached. In the R/R EBV+ PTCL population, the overall response rate (ORR) was 33% and the complete response rate (CRR) was 19% in the intent-to-treat (ITT) population (N=21); the ORR was 41% and the CRR was 24% in the efficacy-evaluable (EE) population (N=17).Notably, there was a particularly robust clinical response observed in the second-line EBV+ PTCL subpopulation, as the ORR was 60% and the CRR was 30% in the intent-to-treat population (n=10), and the ORR was 67% and the CRR was 33% in the efficacy-evaluable population (n=9). Held a productive FDA meeting to align on a potential regulatory path forward for Nana-val in patients with R/R EBV+ PTCL. Based on feedback from the FDA and the particularly robust response rates observed in the second-line treatment setting, Viracta will focus the primary analysis on the second-line EBV+ PTCL subpopulation in the ongoing NAVAL-1 trial’s expansion phase. The Company plans to begin a randomized controlled trial (RCT) of Nana-val in the second-line treatment of EBV+ PTCL patients in 2025. Viracta believes this strategy will best position Nana-val for a potential NDA filing in 2026 for accelerated approval based on an interim analysis of second-line EBV+ PTCL patient data from the NAVAL-1 trial, provided that the ORR and DOR are compelling and the RCT is well underway; for accelerated approval based on final analysis of NAVAL-1 trial data; or for accelerated or full approval based on the outcomes of the RCT at interim or final analysis, respectively. Anticipated MilestonesViracta plans to deliver on the following milestones: The recommended Phase 2 dose in patients with advanced EBV+ solid tumors is expected to be determined in the second half of 2024.Report additional data from the expansion phase of the NAVAL-1 trial in second-line EBV+ PTCL patients in the fourth quarter of 2024.Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) in the first half of 2025.Meet with the FDA to finalize the proposed RCT design in the second-line treatment of patients with EBV+ PTCL in the first half of 2025. Initiate the RCT in the second half of 2025. Present interim analysis outcomes from the NAVAL-1 trial in second-line EBV+ PTCL patients in 2026.File NDA for accelerated approval in 2026 based on interim analysis of the NAVAL-1 trial’s expansion cohort. Business Updates Appointed Michael Faerm as Chief Financial Officer. Mr. Faerm is a seasoned biotech executive with more than 25 years of experience in life sciences companies, equity research and investment banking.Viracta has aligned resources to prioritize its more advanced EBV+ lymphoma and will pause its EBV+ solid tumor program. Along with this pipeline reprioritization, a reduction in force has been implemented that impacts approximately 23% of the company’s employees. Second Quarter 2024 Financial Results Cash position – Cash, cash equivalents, and short-term investments totaled approximately $30.0 million as of June 30, 2024, which Viracta expects will be sufficient to fund operations late into the first quarter of 2025.Research and development expenses – Research and development expenses were approximately $6.5 million and $16.5 million for the three and six months ended June 30, 2024, respectively, compared to approximately $8.2 million and $15.8 million for the same periods in 2023. The decrease in research and development expenses for the three months ended June 30, 2024 compared to the same period in 2023, was driven by decreases in costs incurred to support the advancement and expansion of our clinical development programs, including incremental costs to support NAVAL-1, our Phase 2 trial of Nana-val in patients with R/R EBV+ lymphomas and personnel-related costs. The increase in research and development expenses for the six months ended June 30, 2024 compared to the same period in 2023, was largely due to a non-cash adjustment for insurance costs related to the February 2021 reverse merger with Sunesis Pharmaceuticals of $1.8 million, partially offset by decrease in costs incurred related to our clinical development programs and personnel-related costs.General and administrative expenses – General and administrative expenses were approximately $3.0 million and $7.0 million for the three and six months ended June 30, 2024, respectively, compared to $4.3 million and $8.9 million for the same periods in 2023. The decrease in general and administrative expenses was largely due to decreases in personnel-related costs, corporate liability insurance premiums and legal costs.Net loss – Net loss was approximately $9.8 million, or $0.25 per share (basic and diluted), for the quarter ended June 30, 2024, compared to a net loss of $12.5 million, or $0.32 per share (basic and diluted), for the same period in 2023. This change was primarily the result of decreases in research and development expenses and personnel-related costs. Net loss was approximately $19.0 million, or $0.48 per share, (basic and diluted) for the six months ended June 30, 2024, compared to a net loss of $24.7 million, or $0.64 per share, (basic and diluted) for the same period in 2023. This change was primarily the result of $5.0 million of other income received related to the monetization of a pre-commercialization, event-based milestone from Day One Biopharmaceuticals, Inc. in March 2024, partially offset by the non-cash adjustment for insurance costs related to the February 2021 merger of $1.8 million. About the NAVAL-1 TrialNAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of three indication cohorts based on EBV+ lymphoma subtype. If two objective responses are achieved within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration. About Nana-val (Nanatinostat and Valganciclovir)Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a potentially registrational, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other advanced EBV+ solid tumors. About Peripheral T-Cell LymphomaT-cell lymphomas comprise a heterogeneous group of rare and aggressive malignancies, including peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL). There are approximately 5,600 newly diagnosed T-cell lymphoma patients and approximately 2,600 newly diagnosed PTCL-NOS and AITL patients in the U.S. annually. Approximately 70% of these patients are either refractory to first-line therapy, or eventually experience relapse of their disease. Clinical trials are currently recommended for all lines of PTCL therapy, and most patients with R/R PTCL have poor outcomes, with median progression-free survival and median overall survival times reported to be 3.7 and 6.5 months, respectively. Approximately 40% to 65% of PTCL is associated with EBV, the incidence of EBV+ PTCL varies by geography, and reported outcomes for patients with EBV+ PTCL are inferior to those whose disease is EBV-negative. There is no approved targeted treatment specific for EBV+ PTCL, and therefore this represents a high unmet medical need. About EBV-Associated CancersApproximately 90% of the world's adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient's life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer. About Viracta Therapeutics, Inc.Viracta is a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide. Viracta’s lead product candidate is an all-oral combination therapy of its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir (collectively referred to as Nana-val). Nana-val is currently being evaluated in multiple ongoing clinical trials, including a potentially registrational, global, multicenter, open-label Phase 2 basket trial for the treatment of multiple subtypes of relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational, open-label Phase 1b/2 clinical trial for the treatment of patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors. Viracta is also pursuing the application of its “Kick and Kill” approach in other virus-related cancers. For additional information, please visit www.viracta.com. Forward-Looking StatementsThis communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the details, timeline and expected progress for Viracta's ongoing and anticipated clinical trials and updates regarding the same, Viracta’s clinical focus and strategy, the Company’s expectations related to the FDA submission process and timelines, expectations regarding the Company’s target patient populations, and expectations regarding the Company’s cash runway. 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 supply nanatinostat, valganciclovir, and pembrolizumab for clinical testing; and Viracta's estimates regarding its ability to fund ongoing operations into 2025, future expenses, capital requirements, and need for additional financing in the future. 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:Michael FaermChief Financial OfficerViracta Therapeutics, Inc.ir@viracta.com SOURCE Viracta Therapeutics, Inc. -- Financial tables attached – Viracta Therapeutics, Inc.Selected Balance Sheet Highlights(in thousands) June 30, December 31, 2024 2023 (Unaudited) Cash, cash equivalents and short-term investments$30,005 $53,691 Total assets$31,322 $56,692 Total liabilities$28,651 $38,373 Stockholders' equity$2,671 $18,319 Viracta Therapeutics, Inc.Condensed Consolidated Statement of Operations and Comprehensive Loss(in thousands except share and per share data)(Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Operating expenses: Research and development$6,548 $8,197 $16,504 $15,804 General and administrative 3,041 4,253 6,961 8,853 Total operating expenses 9,589 12,450 23,465 24,657 Loss from operations (9,589) (12,450) (23,465) (24,657)Total other income (expense) (241) (34) 4,494 (36)Net loss (9,830) (12,484) (18,971) (24,693)Unrealized gain (loss) on short-term investments 1 (28) (14) 63 Comprehensive loss (9,829) (12,512) (18,985) (24,630)Net loss per share, basic and diluted$(0.25) $(0.32) $(0.48) $(0.64)Weighted-average common shares outstanding, basic and diluted 39,404,975 38,560,376 39,364,469 38,509,887

- New combined Stage 1 and Stage 2 results from the relapsed or refractory EBV-positive peripheral T-cell lymphoma (PTCL) cohort of the Phase 2 NAVAL-1 trial further demonstrate Nana-val’s substantial antitumor activity and generally well-tolerated safety profile - - Productive FDA meeting held to align on a potential regulatory path forward for Nana-val in patients with relapsed or refractory EBV-positive PTCL - - Updated Nana-val clinical development plan implemented to optimize its clinical benefit in EBV-positive PTCL patients and expedite a randomized controlled trial to support potential registration - - Viracta to host conference call and webcast on Wednesday, August 14 at 8:30 a.m. ET, featuring Pierluigi Porcu, M.D., Professor of Medical Oncology, Director of the Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation at Thomas Jefferson University - SAN DIEGO, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today reported positive Phase 2 NAVAL-1 trial results from Stages 1 and 2 of the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) cohort. Additionally, the Company received productive feedback from its meeting with the U.S. Food and Drug Administration (FDA), providing clarity on the potential regulatory path to initial registration of Nana-val in patients with R/R EBV+ PTCL. Based on FDA’s feedback, Viracta plans to begin a randomized controlled trial (RCT) of Nana-val in the second half of 2025. “We are pleased to present important additional data from our NAVAL-1 trial, which further supports Nana-val’s potential to address the high unmet medical needs of patients living with relapsed or refractory EBV-positive PTCL,” said Darrel P. Cohen, M.D., Ph.D., Chief Medical Officer of Viracta. “Nana-val demonstrated substantial antitumor activity with a generally well-tolerated safety profile across Stage 1 and Stage 2 of the relapsed or refractory EBV-positive PTCL cohort, with a median duration of response that has not yet been reached. We are also encouraged by the particularly robust clinical responses observed in the second-line EBV-positive PTCL subgroup.” Mark Rothera, President and Chief Executive Officer of Viracta, added, “Aligning with the FDA on the potential path forward in relapsed or refractory EBV-positive PTCL marks a critical step towards bringing Nana-val to patients. EBV-positive PTCL is an aggressive cancer with survival rates that decline precipitously 12-24 months after diagnosis. Published literature suggests that EBV-positive lymphomas are a distinct oncological disease associated with poorer survival outcomes than EBV-negative lymphomas. We believe it is critical to treat these patients as early as possible with an EBV-targeted therapy to improve patient outcomes. Our updated Nana-val clinical development plan is designed to address this urgent need and expedite a randomized controlled trial, which we plan to initiate in 2025 to support potential registration.” Key Takeaways from the R/R EBV+ PTCL Cohort of the Phase 2 NAVAL-1 TrialOverview: A total of 21 patients with primarily Stage III-IV disease (who had received ≥1 [median 2] prior systemic PTCL therapies) received nanatinostat (20 mg orally once daily, 4 days/week) in combination with valganciclovir (900 mg orally once daily, 7 days/week) across the first two stages of the study. Data generated from the expansion phase of the R/R EBV+ PTCL cohort may be shared in future updates. As of the June 28, 2024 data cutoff, combined Stages 1 and 2 data demonstrated: In the R/R EBV+ PTCL population: The overall response rate (ORR) was 33% and the complete response rate (CRR) was 19% in the intent-to-treat (ITT) population (n=21); the ORR was 41% and the CRR was 24% in the efficacy-evaluable (EE) population (n=17). In the second-line EBV+ PTCL subpopulation: The ORR was 60% and the CRR was 30% in the ITT population (n=10); the ORR was 67% and the CRR was 33% in the EE population (n=9). Median duration of response (DOR) has not yet been reached. Two responding patients proceeded to hematopoietic stem-cell transplant without relapse, one of whom remains in response over 16 months. Nana-val was generally well-tolerated: The most common treatment-related adverse events were fatigue, nausea, decreased appetite, diarrhea, platelet count decreased, and anemia. These adverse events were primarily mild to moderate in severity and generally manageable or reversible. Nana-val Clinical Development Plan: Next StepsBased on the Company’s meeting with FDA and the particularly robust response rates observed in the second-line treatment setting, Viracta will focus Nana-val’s clinical development on patients with R/R EBV+ PTCL as follows: First, the Company will focus the primary analysis on the second-line EBV+ PTCL subpopulation in the ongoing NAVAL-1 trial’s expansion phase. Second, the Company plans to begin an RCT of Nana-val in the second-line treatment of EBV+ PTCL patients in 2025. Viracta believes this strategy will best position Nana-val for a potential NDA filing in 2026 for accelerated approval based on an interim analysis of second-line EBV+ PTCL patient data from the NAVAL-1 trial, provided that the ORR and DOR are compelling and the RCT is well underway. In addition, it creates the opportunity for accelerated approval based on final analysis of NAVAL-1 trial data, or for accelerated or full approval based on the outcomes of the RCT at interim or final analysis, respectively. Corporate Update Viracta has aligned resources to prioritize its EBV+ lymphoma program and plans to deliver on key potential Nana-val development milestones as follows: Pause the EBV+ solid tumor program to focus resources on the more advanced EBV+ lymphoma program. The recommended Phase 2 dose in patients with advanced EBV+ solid tumors is expected to be determined in the second half of 2024. Report additional data from the ongoing expansion phase of the NAVAL-1 trial in second-line EBV+ PTCL patients in the fourth quarter of 2024.Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) in the first half of 2025.Meet with the FDA to finalize the proposed RCT design in the second-line treatment of patients with EBV+ PTCL in the first half of 2025. Initiate the RCT in the second half of 2025. Present interim analysis outcomes from the expansion phase of the NAVAL-1 trial in second-line EBV+ PTCL patients in 2026.File NDA for accelerated approval in 2026 based on interim analysis of the NAVAL-1 trial’s expansion cohort. Along with this pipeline reprioritization, a reduction in force has been implemented that impacts approximately 23% of the Company’s employees. Conference CallViracta will host an investor call on Wednesday, August 14 at 8:30 a.m. ET to discuss the positive Phase 2 NAVAL-1 trial results from Stages 1 and 2 of the R/R EBV+ PTCL cohort. A live question and answer session will follow the formal presentation. To register, click here. About the NAVAL-1 TrialNAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of three indication cohorts based on EBV+ lymphoma subtype. If two objective responses are achieved within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration. About Nana-val (Nanatinostat and Valganciclovir)Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a potentially registrational, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other advanced EBV+ solid tumors. About Peripheral T-Cell LymphomaT-cell lymphomas comprise a heterogeneous group of rare and aggressive malignancies, including peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL). There are approximately 5,600 newly diagnosed T-cell lymphoma patients and approximately 2,600 newly diagnosed PTCL-NOS and AITL patients in the U.S. annually. Approximately 70% of these patients are either refractory to first-line therapy, or eventually experience relapse of their disease. Clinical trials are currently recommended for all lines of PTCL therapy, and most patients with R/R PTCL have poor outcomes, with median progression-free survival and median overall survival times reported to be 3.7 and 6.5 months, respectively. Approximately 40% to 65% of PTCL is associated with EBV, the incidence of EBV+ PTCL varies by geography, and reported outcomes for patients with EBV+ PTCL are inferior to those whose disease is EBV-negative. There is no approved targeted treatment specific for EBV+ PTCL, and therefore this represents a high unmet medical need. About EBV-Associated CancersApproximately 90% of the world's adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient's life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer. About Viracta Therapeutics, Inc.Viracta is a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide. Viracta’s lead product candidate is an all-oral combination therapy of its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir (collectively referred to as Nana-val). Nana-val is currently being evaluated in multiple ongoing clinical trials, including a potentially registrational, global, multicenter, open-label Phase 2 basket trial for the treatment of multiple subtypes of relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational, open-label Phase 1b/2 clinical trial for the treatment of patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors. Viracta is also pursuing the application of its “Kick and Kill” approach in other virus-related cancers. For additional information, please visit www.viracta.com. Forward-Looking StatementsThis communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the details, timeline and expected progress for Viracta's ongoing and anticipated clinical trials and updates regarding the same, Viracta’s clinical focus and strategy, the Company’s expectations related to the FDA submission process and timelines, expectations regarding the Company’s target patient populations, and expectations regarding the Company’s cash runway. 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 and the clinical utility, potential benefits, and market acceptance of Viracta's product candidates; Viracta's ability to manufacture or supply nanatinostat and valganciclovir for clinical testing. 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:Michael FaermChief Financial OfficerViracta Therapeutics, Inc.ir@viracta.com SOURCE Viracta Therapeutics, Inc.

Early Results from Soquelitinib Phase 1 Randomized Trial in Atopic Dermatitis Demonstrate Clinical Activity and Corresponding Changes in Cytokine Levels Consistent with ITK Inhibition Mechanism of Action Soquelitinib Registration Phase 3 Trial in Peripheral T Cell Lymphoma (PTCL) Advancing Toward Initial Enrollment in Q3 2024; New Complete Response Achieved in Ongoing Phase 1/1b Clinical Trial Conference call today at 4:30 p.m. ET / 1:30 p.m. PT BURLINGAME, Calif., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the second quarter ended June 30, 2024. “We have seen growing evidence supporting the central role of ITK in T cell biology and the significant potential of ITK inhibition as a new mechanism to treat a broad range of immune diseases and cancers,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “This includes early data from our Phase 1 clinical trial of soquelitinib in atopic dermatitis and our ongoing preclinical work exploring ITK inhibition in autoimmunity and inflammation. Based on this, we are increasingly optimistic that our ITK platform has the potential to improve clinical outcomes for a range of indications as an oral medication with an attractive tolerability profile. We have leveraged our experience in T cell lymphomas which has allowed us to gain a deeper understanding of the role of ITK in T cell biology that we can now apply to immune diseases. We remain on track to initiate a Phase 3 registrational trial in PTCL in the third quarter.” Business Update and Strategy Prioritized Program: Soquelitinib (formerly CPI-818, Corvus’ selective ITK inhibitor) Soquelitinib for Immune Diseases Corvus continues to enroll patients at multiple clinical sites in its randomized, placebo-controlled Phase 1 clinical trial of soquelitinib in patients with moderate to severe atopic dermatitis. The trial is planned to enroll 64 patients that have failed at least one prior therapy across four different 28-day dosing regimens of soquelitinib compared to a placebo group. The endpoints include safety and improvement in Eczema Area and Severity Index. Patients and physicians will be blinded to treatment assignment. Initial results, as of July 31, 2024, from three evaluable patients in the first cohort of the trial that completed the 28-day dosing regimen and follow-up visit demonstrated signs of clinical activity and corresponding changes in serum cytokine levels that are consistent with soquelitinib’s mechanism of action. These patients received a dose of 100 mg two-times a day, the lowest dose level planned for the study. Corvus anticipates interim data from the Phase 1 clinical trial will be presented in the fourth quarter of 2024. Recent published data from researchers at Cornell University demonstrated that ITK controls the fate of inflammatory Th17 cells. When ITK is inhibited by soquelitinib, the Th17 cells convert or switch to Treg cells that suppress inflammation. Soquelitinib treatment in an asthma model of mice with allergic airway inflammation significantly reduced the percentage of Th17 cells in the lung resulting in an increase in the ratio of Treg to Th17 cells. These studies confirm our understanding of the role of specific ITK inhibition in inflammation and are relevant to many immune diseases.Corvus continues to advance its next-generation ITK inhibitor preclinical product candidates, which were designed to deliver precise T-cell modulation that is optimized for specific immunology indications. The next-generation ITK inhibitor candidates are part of the Company’s ongoing business development efforts to maximize the potential of the Company’s ITK inhibitor programs in immune diseases and cancers. Soquelitinib for T Cell Lymphoma Corvus continues to follow patients with relapsed T cell lymphoma in its Phase 1/1b clinical trial (no longer enrolling new patients) evaluating single agent therapy with soquelitinib. Updated interim data as of July 16, 2024: A total of 25 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg two-times a day dose and meet the eligibility criteria for the planned registrational Phase 3 clinical trial based on ≥1 and ≤3 prior therapies, including 23 evaluable patients.For the 23 evaluable patients, objective responses (complete response, CR plus partial response, PR) were seen in nine patients (39%), including six CRs (26%) and three PRs. Compared to the prior data reported as of May 3, 2024, one patient with continued tumor regression achieved a CR that previously had a PR at the first follow up visit. See waterfall plot below.Disease control (CR, PR and stable disease) was seen in 14 of 23 patients (61%). The stable disease group included five patients who achieved tumor reductions that did not meet the criteria for a PR. Corvus anticipates initiating a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL in the third quarter of 2024. There are currently no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma. Recently, the Company received a Pediatric Waiver from the FDA indicating that it would not be required to conduct clinical trials in a pediatric population for this indication.As recently announced, soquelitinib has received Fast Track designation for treatment of adult patients with relapsed or refractory peripheral T cell lymphoma after at least 2 lines of systemic therapy. Waterfall Plot for Patients in the 200 mg Dose Cohort of the Soquelitinib Phase 1/1b Clinical Trial for Peripheral T Cell Lymphoma. The plot shows the best percent change in tumor volume in the 23 evaluable patients (eligible patient population), as of July 16, 2024, that were measurable by CT scan or by Modified Severity-Weighted Assessment Tool (mSWAT) for patients with cutaneous involvement. PTCL-NOS, peripheral T cell lymphoma not otherwise specified; CTCL, cutaneous T cell lymphoma of either Sezary or mycosis fungoides type; NKTCL, natural killer cell T cell lymphoma; ALCL, anaplastic large cell lymphoma; AITL, angioimmunoblastic T cell lymphoma. Collaboration with Kidney Cancer Research Consortium: Ciforadenant (adenosine A2a receptor inhibitor) Corvus is collaborating with the Kidney Cancer Research Consortium in a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The efficacy endpoint for the trial is deep response rate, defined as CR plus PRs of greater than 50% tumor volume reduction. The clinical trial is expected to enroll up to 60 patients and as of May 31, 2024 a total of 32 patients were enrolled in the trial. The protocol defined, interim pre-specified statistical threshold for efficacy is a 50% increase above the 32% deep response rate seen with previous ipilimumab/nivolumab combination trials in RCC conducted by investigators at the Kidney Cancer Research Consortium. As of May 31, 2024, the interim analysis of the clinical trial has met the threshold for efficacy and therefore enrollment continues.In July 2024, a new U.S. patent was issued (United States Patent No. 12,023,337) by the U.S. Patent and Trademark Office that covers the use of ciforadenant for the treatment of cancer; foreign counterparts are pending. Partner Led Program: Mupadolimab (anti-CD73) Angel Pharmaceuticals, Corvus’ partner in China, is enrolling patients in an expansion cohort of a Phase 1/1b clinical trial of mupadolimab in patients with relapsed non-small cell lung cancer (NSCLC). In this clinical trial, patients will receive mupadolimab monotherapy. Financial Results As of June 30, 2024, Corvus had cash, cash equivalents and marketable securities of $47.2 million as compared to $27.1 million as of December 31, 2023. During the quarter ended June 30, 2024, the Company completed a registered direct offering in which it sold shares of common stock, pre-funded warrants and common warrants, generating $30.3 million in net proceeds. Corvus expects full year 2024 net cash used in operating activities to be between approximately $24 million and $27 million, resulting in a projected cash balance of between approximately $31 million and $34 million at December 31, 2024. Based on its current plans, Corvus expects its cash to fund operations into the fourth quarter of 2025. Research and development expenses for the three months ended June 30, 2024 totaled $4.1 million compared to $4.0 million for the same period in 2023. The increase of $0.1 million was primarily due to higher clinical trial costs associated with the development of soquelitinib. The net loss for the three months ended June 30, 2024 was $4.3 million compared to a net loss of $6.5 million for the same period in 2023. Total stock compensation expense for the three months ended June 30, 2024 was $0.8 million compared to $0.5 for the same period in 2023 and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.6 million for the three months ended June 30, 2024 compared to a loss of $1.3 million for the same period in 2023. In addition, the Company recorded a non-cash gain of $1.8 million from the change in fair value of its warrant liability during the three months ended June 30, 2024 due to the warrants issued in the registered direct offering. Conference Call DetailsCorvus will host a conference call and webcast today, Tuesday, August 6, 2024, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2024 financial results. The conference call can be accessed by dialing 1- 800-717-1738 (toll-free domestic) or 1- 646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days. About Corvus PharmaceuticalsCorvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com. About SoquelitinibSoquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company plans to initiate a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL. Soquelitinib also is now being investigated in a randomized placebo controlled phase 1 clinical trial in patients with atopic dermatitis. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and inhibition of Th2 and Th17 cells. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. About Peripheral T Cell LymphomaPeripheral T cell lymphoma is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. First line treatment for these diseases is typically combination chemotherapy, however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the three to four month range and overall median survival of six to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials. PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype. About Atopic DermatitisAtopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to 20% of children and up to 10% of adults, and treatments include topical therapies, oral therapies and systemic injectable biologic therapies. It is frequently associated with other allergic disorders such as food allergies and asthma. Atopic dermatitis, like asthma and allergy, involves the participation of Th2 lymphocytes which secrete cytokines that result in inflammation. Soquelitinib has been shown in preclinical studies to inhibit cytokine production from Th2 lymphocytes. About CiforadenantCiforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine to immune cells present in the tumor microenvironment. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2a receptor present on immune cells and block their activity. Ciforadenant has been shown to block the immunosuppressive effects of myeloid cells present in tumors and preclinical studies published in 2018 demonstrated synergy with combinations of anti PD1 and anti-CTLA4 antibodies. About MupadolimabMupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents react with a different region of CD73. Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is postulated that the activation of B cells will enhance immunity within the tumors of these patients, leading to improved clinical outcomes. About Angel PharmaceuticalsAngel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with U.S.-based Corvus and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – soquelitinib, ciforadenant and mupadolimab – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus currently has a 49.7% equity stake in Angel Pharmaceuticals excluding 7% of Angel’s equity reserved for issuance under the Angel ESOP, and Corvus has designated three individuals on Angel’s five-person Board of Directors. For more information, visit www.angelpharma.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates including soquelitinib, ciforadenant and mupadolimab; the potential use of soquelitinib to treat a variety of hematological cancers and autoimmune diseases; the Company’s ability and its partners’ ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1 clinical trial for atopic dermatitis with soquelitinib; the timing of and the Company’s ability to launch clinical trials, including the soquelitinib registrational Phase 3 clinical trial for PTCL; the design of clinical trials, including the timeline for initiation, target or expected number of patients to be enrolled, expected number of sites and certain other product development milestones, including in regards to the Phase 1 clinical trial for atopic dermatitis with soquelitinib; the availability and timing of clinical and preclinical data announcements and clinical readouts, including early data from the Phase 1 clinical trial for atopic dermatitis with soquelitinib and preclinical data supporting the broad potential of ITK inhibition in immune and inflammatory disease; the estimated amount of net cash used in operating activities for 2024 and its ability to fund operations into the fourth quarter of 2025. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2024, filed with the Securities and Exchange Commission on or about the date hereof, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of soquelitinib and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the amount of net cash used in operating activities for 2024 and cash on hand providing funding into the fourth quarter of 2025 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. The Company’s results for the quarter ended June 30, 2024 are not necessarily indicative of its operating results for any future periods. CORVUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 (unaudited) (unaudited)Operating expenses: Research and development $4,114 $3,968 $8,189 $8,562 General and administrative 1,821 1,654 3,999 3,634 Total operating expenses 5,935 5,622 12,188 12,196 Loss from operations (5,935) (5,622) (12,188) (12,196)Interest income and other expense, net 434 403 750 779 Change in fair value of warrant liability 1,816 — 1,816 — Sublease income - related party — — — 56 Loss from equity method investment (577) (1,284) (341) (3,015)Net loss $(4,262) $(6,503) $(9,963) $(14,376)Net loss per share, basic and diluted $(0.07) $(0.14) $(0.18) $(0.31)Shares used to compute net loss per share, basic and diluted 59,710,265 47,497,414 54,374,423 47,029,396 CORVUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) June 30, December 31, 2024 2023 (unaudited) Assets Cash, cash equivalents and marketable securities $47,246 $27,149 Operating lease right-of-use asset 578 1,149 Other assets 1,333 1,132 Investment in Angel Pharmaceuticals 15,404 16,123 Total assets $64,561 $45,553 Liabilities and stockholders' equity Accounts payable and accrued liabilities and other liabilities $5,517 $5,495 Operating lease liability 700 1,374 Warrant liability 7,118 — Stockholders' equity 51,226 38,684 Total liabilities and stockholders' equity $64,561 $45,553 INVESTOR CONTACT:Leiv LeaChief Financial OfficerCorvus Pharmaceuticals, Inc.+1-650-900-4522llea@corvuspharma.com MEDIA CONTACT:Sheryl SeapyReal Chemistry+1-949-903-4750sseapy@realchemistry.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a451d560-a41c-4487-99ca-cd7de11e4274