SAN DIEGO, Feb. 05, 2025 (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, announced today that the Company has terminated its employees and will wind down operations. The company is also exploring potential strategic alternatives for its development programs. The board of directors appointed Craig R. Jalbert, age 63, as the Company’s CEO, President, CF ...

SAN DIEGO, Dec. 26, 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 announced that its Board of Directors has initiated a process to explore a broad range of strategic alternatives. To maximize its cash runway while the Board conducts its review of strategic alternatives, Viracta has elected to close its ongoing pivotal Phase 2 clinical tria ...

Shares of Viracta (VIRX) have been struggling lately and have lost 17.1% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road. While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts about the future earnings ...

Viracta Therapeutics (NASDAQ:VIRX) stock is heading higher on Wednesday after the clinical-stage precision oncology company released its Q2 earnings report. The first bit of news boosting VIRX stock higher is its diluted earnings per share of -25 cents. That's better than the -37 cents per share Wall Street was predicting. It's also an improvement over the company's EPS of -32 cents from the same period of the year prior. Viracta Therapeutics notes that the improvement in its EPS comes from a $5 million of ...

Clinical Trial Results - Reported positive combined Stage 1 and Stage 2 results from the NAVAL-1 trial, showing an overall response rate (ORR) of 33% and a complete response rate (CRR) of 19% in the intent-to-treat population[3] - In the second-line EBV-positive PTCL subgroup, the ORR was 60% and the CRR was 30% in the intent-to-treat population, indicating a robust clinical response[4] - Additional data from the NAVAL-1 trial's expansion phase is expected to be reported in Q4 2024[5] - Viracta plans to initiate a randomized controlled trial in the second half of 2025 to support potential registration of Nana-val[4] - The company aims to file a New Drug Application (NDA) for accelerated approval in 2026 based on interim analysis of the NAVAL-1 trial data[5] Financial Performance - Net loss for Q2 2024 was approximately $9.8 million, or $0.25 per share, compared to a net loss of $12.5 million, or $0.32 per share, for the same period in 2023[7] - The net loss for the three months ended June 30, 2024, was $9,830,000, compared to a net loss of $12,484,000 in the same period of 2023, indicating an improvement of approximately 21%[17] - The net loss per share for the three months ended June 30, 2024, was $(0.25), an improvement from $(0.32) in the same period of 2023[17] - Comprehensive loss for the three months ended June 30, 2024, was $9,829,000, compared to $12,512,000 in the same period of 2023, reflecting a decrease of about 21%[17] - Total other income for the six months ended June 30, 2024, was $4,494,000, a significant increase compared to an expense of $(36,000) in the same period of 2023[17] Cash and Assets - Cash position as of June 30, 2024, was approximately $30.0 million, expected to fund operations into the first quarter of 2025[7] - As of June 30, 2024, cash, cash equivalents, and short-term investments decreased to $30,005,000 from $53,691,000 on December 31, 2023, representing a decline of approximately 44%[16] - Total assets decreased to $31,322,000 as of June 30, 2024, down from $56,692,000 at the end of 2023, indicating a reduction of about 45%[16] - Total liabilities decreased to $28,651,000 as of June 30, 2024, compared to $38,373,000 on December 31, 2023, reflecting a decrease of approximately 25%[16] Expenses - Research and development expenses for Q2 2024 were approximately $6.5 million, a decrease from $8.2 million in Q2 2023, driven by reduced costs in clinical development programs[7] - Research and development expenses for the three months ended June 30, 2024, were $6,548,000, down from $8,197,000 in the same period of 2023, a reduction of about 20%[17] - General and administrative expenses decreased to $3,041,000 for the three months ended June 30, 2024, from $4,253,000 in the prior year, a decline of approximately 29%[17] - Total operating expenses for the three months ended June 30, 2024, were $9,589,000, down from $12,450,000 in the same period of 2023, representing a decrease of about 23%[17] Management Changes - Appointed Michael Faerm as Chief Financial Officer, bringing over 25 years of experience in life sciences[6] - Viracta will pause its EBV-positive solid tumor program and focus resources on the more advanced EBV-positive lymphoma program, resulting in a reduction of approximately 23% of its workforce[6]

- 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 - ...

Clinical Trials and Product Development - Viracta's lead product candidate, Nana-val, is currently being investigated in multiple ongoing clinical trials, including a pivotal Phase 2 trial (NAVAL-1) for relapsed/refractory EBV+ lymphoma[73] - In the NAVAL-1 trial, the overall response rate for patients treated with Nana-val was 50%, with a complete response rate of 20% in the intent-to-treat population[77] - The company completed enrollment of Stage 1 in the R/R EBV+ PTCL cohort with 10 patients treated with Nana-val, and anticipates beginning enrollment for a post-Phase 2 expansion cohort in Q2 2024[77] - In the Phase 1b/2 trial for recurrent or metastatic EBV+ nasopharyngeal carcinoma, Viracta reported two confirmed partial responses and five stable diseases among 17 patients enrolled[79] - The company has amended the NAVAL-1 protocol to prioritize three lymphoma subtypes, focusing resources on indications with the greatest probability of success[75] - Viracta plans to meet with the FDA in mid-2024 to discuss preliminary results and additional requirements for accelerated approval[77] Financial Performance and Expenses - General and administrative expenses are expected to increase as Viracta prepares for potential commercialization of Nana-val and continues to comply with SEC requirements[86] - Research and development expenses are primarily related to the development of Nana-val, with significant costs anticipated for ongoing clinical trials[83] - Research and development expenses increased by approximately $2.3 million to $9.956 million for the three months ended March 31, 2024, compared to $7.607 million for the same period in 2023[94] - General and administrative expenses decreased by approximately $0.7 million to $3.920 million for the three months ended March 31, 2024, compared to $4.600 million for the same period in 2023[95] - As of March 31, 2024, the accumulated deficit was $275.1 million, with expectations of continued net losses and operating cash outflows for at least the next several years[96] - Cash, cash equivalents, and short-term investments totaled $39.6 million, with working capital of $10.7 million as of March 31, 2024[96] - Net cash used in operating activities was $7.849 million for the three months ended March 31, 2024, an improvement from $11.340 million for the same period in 2023[102] - Net cash provided by investing activities was $14.192 million for the three months ended March 31, 2024, compared to a net cash outflow of $7.350 million for the same period in 2023[103] - Net cash used in financing activities was $6.598 million for the three months ended March 31, 2024, primarily due to debt principal payments and a prepayment totaling $6.7 million[104] - The company sold 137,783 shares of common stock at a weighted average price of $0.60, raising $0.1 million during the three months ended March 31, 2024[97] - The company entered into a Second Amendment under the SVB-Oxford Loan Facility, making a prepayment of $5.0 million toward the outstanding principal in March 2024[99] - The company anticipates ongoing expenses and increased operating losses, with future funding requirements dependent on various factors including clinical development activities and commercialization efforts[105] Agreements and Collaborations - Company entered into a Royalty Purchase Agreement with XOMA for an upfront payment of $13.5 million, related to future milestones and royalties from license agreements with Day One and Denovo Biopharma[109] - An amendment to the license agreement with Day One was made on March 4, 2024, monetizing a pre-commercialization milestone for $5.0 million, received in March 2024[109] - The milestone percentage under the agreement with Day One was reduced following the monetization[109] - The Royalty Purchase Agreement with XOMA was amended to modify the economic value-share, allowing the company to participate in a future pre-commercialization milestone up to $5.0 million under certain circumstances[109] Market Risks and Challenges - The company is actively monitoring macroeconomic factors, including inflation and geopolitical tensions, that may impact its business operations[82] - Company faces market risks including interest rate sensitivities related to short-term investments and outstanding loans[110] - Variability in clinical trial subjects and adjustments to procedures may occur, impacting trial outcomes[110] - FDA may not agree with the analysis of clinical trial results, potentially affecting marketing approval[110] - Clinical trial results may not meet required statistical or clinical significance for FDA approval[110] - Company may face challenges in obtaining, maintaining, and enforcing patents and intellectual property rights[110] - Establishing commercial-scale manufacturing and commercialization capabilities may pose significant risks[110]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 000-51531 VIRACTA THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) Delaware 94-3295878 (State or other jurisdict ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) [Q4 and Full Year 2023 Highlights](index=1&type=section&id=Q4%20and%20Full%20Year%202023%20Highlights) Viracta Therapeutics reported **Q4** and **full-year 2023** financial results and provided a business update, highlighting significant progress in its clinical trials for Nana-val, particularly the completion of **Stage 2** enrollment in the NAVAL-1 trial for **EBV+** PTCL and enrollment in the Phase 1b/2 study for advanced **EBV+** solid tumors, and also strengthened its balance sheet through **non-dilutive proceeds** financing, extending its **cash runway** into **mid-Q1 2025** - Completed **Stage 2** enrollment in the NAVAL-1 trial of Nana-val in patients with **relapsed or refractory** **EBV+** peripheral T-cell lymphoma (PTCL), supporting its speed-to-market strategy[1](index=1&type=chunk) - Completed enrollment into the first split daily dosing cohort of the Phase 1b/2 study of Nana-val in patients with advanced **EBV+** solid tumors[1](index=1&type=chunk) - Strengthened **balance sheet** following receipt of **non-dilutive proceeds** of **$5.0 million** through monetization of a pre-commercialization, event-based milestone from Day One Biopharmaceuticals, Inc., extending **cash runway** into **mid-Q1 2025**[1](index=1&type=chunk) - Anticipate reporting topline results from **Stage 1** of the NAVAL-1 study in the **second quarter of 2024** and engaging with the FDA on a potential **accelerated approval pathway** in **mid-2024** for **EBV-positive** PTCL[2](index=2&type=chunk) [Business Updates](index=1&type=section&id=Business%20Updates) [Clinical Trial Updates and Anticipated Milestones](index=1&type=section&id=Clinical%20Trial%20Updates%20and%20Anticipated%20Milestones) Viracta provided updates on its key clinical programs, Nana-val in **EBV+** lymphoma (NAVAL-1) and **EBV+** solid tumors (Study 301), detailing enrollment progress, protocol amendments, and upcoming data readouts and regulatory interactions [Pivotal NAVAL-1 Trial (EBV+ Lymphoma)](index=1&type=section&id=Pivotal%20NAVAL-1%20Trial%20of%20Nana-val%20(nanatinostat%20in%20combination%20with%20valganciclovir)%20in%20patients%20with%20relapsed%20or%20refractory%20(R%2FR)%20Epstein-Barr%20virus-positive%20(EBV%2B)%20lymphoma) - Completed enrollment of **Stage 1** in the R/R **EBV+** PTCL cohort (**n=20**) in **Q4 2023**[3](index=3&type=chunk) - Completed enrollment of **Stage 2** in the R/R **EBV+** PTCL cohort (**n=21 total**) in **Q1 2024**[3](index=3&type=chunk) - Amended protocol to additionally enable enrollment of second-line R/R **EBV+** DLBCL patients and R/R **EBV+** PTLD patients, including pediatric **EBV+** PTLD patients ≥ **12 years of age**[3](index=3&type=chunk) - Anticipated **2024** Milestones include presenting topline **Stage 1** data from both arms of the R/R **EBV+** PTCL cohort in **Q2 2024**, engaging with the FDA in **mid-2024** for **accelerated approval pathway** alignment, presenting **Stage 1** + **Stage 2** data (**n=21**) in the R/R **EBV+** PTCL cohort in **Q3 2024**, and reporting **Stage 1** data from R/R **EBV+** DLBCL and PTLD by **year-end 2024**[3](index=3&type=chunk)[5](index=5&type=chunk) [Phase 1b/2 Study (EBV+ Solid Tumors - Study 301)](index=2&type=section&id=Phase%201b%2F2%20trial%20of%20Nana-val%20in%20patients%20with%20recurrent%2Fmetastatic%20(R%2FM)%20EBV%2B%20nasopharyngeal%20carcinoma%20(NPC)%20and%20other%20advanced%20EBV%2B%20solid%20tumors%20(Study%20301)) - The FDA granted **Orphan Drug Designation (ODD)** to Nana-val for the treatment of NPC in **December 2023**, marking its **fifth FDA ODD**, **seventh ODD globally**, and **first for EBV+ solid tumors**[5](index=5&type=chunk) - Presented data at ESMO Asia Congress **2023** confirming **partial responses** without dose-limiting toxicities through the initial five dose cohorts, supporting continued dose escalation[5](index=5&type=chunk) - Completed enrollment of the **sixth dose cohort** of patients with R/M **EBV+** NPC, evaluating the novel **split daily dosing (SDD) regimen**[5](index=5&type=chunk) - Anticipated **2024** Milestones include determining the **Recommended Phase 2 Dose (RP2D)** in **H2 2024** and initiating a dose-optimization cohort to confirm the **RP2D** as part of the study's **Phase 2 expansion** by **year-end 2024**[5](index=5&type=chunk) [Corporate and Financial Strategy Updates](index=2&type=section&id=Corporate%20and%20Financial%20Strategy%20Updates) Viracta executed several strategic financial transactions, including monetizing a pre-commercialization milestone, amending a royalty purchase agreement, and modifying its loan facility, which collectively strengthened its **balance sheet**, reduced debt, and extended its **cash runway** - Received **$5.0 million** in **non-dilutive proceeds** in **March 2024** related to monetization of a pre-commercialization, event-based milestone from Day One Biopharmaceuticals, Inc[5](index=5&type=chunk) - Amended Royalty Purchase Agreement with XOMA, modifying the economic value-share to retain the right, under certain circumstances, to participate in a pre-commercialization event-based milestone up to **$5.0 million**[5](index=5&type=chunk) - Amended the SVB-Oxford Loan Facility, providing for a modification of the **loan amortization period** and a **pro-rata reduction** in the prospective debt amortization schedule, in exchange for a **partial prepayment** of **$5.0 million**. **Principal amortization will be deferred** between **March and June 2024** (**approximately $2.9 million**), and **prospective amortization payments** in **2024** will be reduced by **approximately $3.3 million**[5](index=5&type=chunk) - Pro forma for this prepayment, the **debt balance has been reduced** by **over 25%** since **year-end** to **$18.6 million**, with anticipation of ending **2024** with **less than $15 million** in debt outstanding[6](index=6&type=chunk) - The totality of these **coordinated transactions** will extend the **cash runway** into **mid-Q1 2025**[6](index=6&type=chunk) [Financial Results](index=3&type=section&id=Fourth-Quarter%20and%20Full-Year%202023%20Financial%20Results) [Fourth-Quarter and Full-Year 2023 Financial Performance Overview](index=3&type=section&id=Fourth-Quarter%20and%20Full-Year%202023%20Financial%20Performance%20Overview) Viracta's financial performance for **Q4** and **full-year 2023** showed **increased R&D expenses** driven by clinical program advancement, a **decrease in G&A expenses** due to **one-time charges** in the prior **year**, and a higher **net loss** for both periods Key Financial Performance Indicators (Q4 and Full Year 2023 vs. 2022) | Metric | Q4 2023 (in millions) | Q4 2022 (in millions) | YoY Change (Q4) | FY 2023 (in millions) | FY 2022 (in millions) | YoY Change (FY) | | :-------------------------------- | :-------------------- | :-------------------- | :---------------- | :-------------------- | :-------------------- | :---------------- | | Cash, cash equivalents, and short-term investments (as of Dec 31) | $53.7 | $91.0 | -41.0% | $53.7 | $91.0 | -41.0% | | Research and development expenses | $9.4 | $6.7 | +40.3% | $33.4 | $26.3 | +27.0% | | General and administrative expenses | $4.2 | $4.9 | -14.3% | $17.3 | $24.3 | -28.8% | | Net loss | $(13.8) | $(10.3) | +34.0% | $(51.1) | $(49.2) | +3.9% | | Net loss per share (basic and diluted) | $(0.35) | $(0.27) | +29.6% | $(1.32) | $(1.30) | +1.5% | - Cash, cash equivalents, and short-term investments totaled **approximately $53.7 million** as of **December 31, 2023**. Pro forma for the aforementioned business transactions, the **cash runway** to fund operations is extended into **mid-Q1 2025**[9](index=9&type=chunk) - The **increase in research and development expenses** in **2023** was primarily driven by increases in costs incurred to support the advancement and expansion of clinical development programs, including NAVAL-1 and Study 301, as well as an increase in personnel-related costs[9](index=9&type=chunk) - The **decrease in G&A expenses** **year** over **year** was largely due to a **one-time expense** associated with the modification of certain equity awards totaling **$5.6 million** and **$0.8 million** in **severance-related charges** associated with the transition of the former Chief Executive Officer in **2022**. The decrease over the comparative three-month period was primarily due to a decrease in **share-based compensation expense** and **corporate liability insurance premiums**[9](index=9&type=chunk) [Selected Balance Sheet Highlights](index=6&type=section&id=Selected%20Balance%20Sheet%20Highlights) Viracta's **balance sheet** as of **December 31, 2023**, shows a decrease in cash and **total assets** compared to the prior **year**, while **total liabilities** increased and **stockholders' equity** decreased significantly Selected Balance Sheet Highlights (as of December 31) | (in thousands) | 2023 | 2022 | | :-------------------------------- | :----- | :----- | | Cash, cash equivalents and short-term investments | $53,691 | $91,043 | | Total assets | $56,692 | $95,991 | | Total liabilities | $38,373 | $34,888 | | Stockholders' equity | $18,319 | $61,103 | [Condensed Consolidated Statement of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20and%20Comprehensive%20Loss) The condensed consolidated statement of operations shows an increase in **total operating expenses** for the **full year 2023**, primarily driven by R&D, leading to a higher **net loss** compared to **2022** Condensed Consolidated Statement of Operations and Comprehensive Loss (in thousands, except per share data) | Metric | Three Months Ended Dec 31, 2023 | Three Months Ended Dec 31, 2022 | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :-------------------------------- | :------------------------------ | :------------------------------ | :---------------------- | :---------------------- | | Research and development | $9,406 | $6,703 | $33,369 | $26,262 | | General and administrative | $4,154 | $4,871 | $17,324 | $24,327 | | Total operating expenses | $13,560 | $11,574 | $50,693 | $50,589 | | Loss from operations | $(13,560) | $(11,574) | $(50,693) | $(50,589) | | Total other income (expense) | $(205) | $1,248 | $(365) | $1,392 | | Net loss | $(13,765) | $(10,326) | $(51,058) | $(49,197) | | Comprehensive loss | $(13,692) | $(10,305) | $(50,871) | $(49,375) | | Net loss per share, basic and diluted | $(0.35) | $(0.27) | $(1.32) | $(1.30) | | Weighted-average common shares outstanding, basic and diluted | 38,790,480 | 38,315,658 | 38,624,462 | 37,790,981 | [Product and Disease Information](index=3&type=section&id=Product%20and%20Disease%20Information) [About the NAVAL-1 Trial](index=3&type=section&id=About%20the%20NAVAL-1%20Trial) NAVAL-1 is a global, multicenter, **pivotal Phase 2 clinical trial** evaluating Nana-val in patients with **relapsed or refractory** (R/R) **Epstein-Barr virus-positive** (**EBV+**) lymphoma, utilizing a **Simon two-stage design** to identify promising subtypes for potential registration - NAVAL-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[8](index=8&type=chunk) - The 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**[8](index=8&type=chunk) - **EBV+** lymphoma subtypes demonstrating promising **antitumor activity** in **Stage 2** may be further expanded following discussion with regulators to potentially support registration[8](index=8&type=chunk) [About the Phase 1b/2 Study of Nana-val in Advanced EBV+ Solid Tumors (Study 301)](index=4&type=section&id=About%20the%20Phase%201b%2F2%20Study%20of%20Nana-val%20in%20Patients%20with%20Advanced%20EBV%2B%20Solid%20Tumors%20(Study%20301)) Study 301 is an open-label, **multinational Phase 1b/2 trial** evaluating Nana-val alone and in combination with pembrolizumab for **recurrent/metastatic** (R/M) **EBV+** nasopharyngeal carcinoma (NPC) and **other advanced EBV+ solid tumors**, focusing on dose escalation, **RP2D** selection, and further evaluation of **antitumor activity** - This **Phase 1b/2 trial** (NCT05166577) is an open-label, multinational clinical trial evaluating Nana-val alone and in combination with pembrolizumab[10](index=10&type=chunk) - The **Phase 1b dose escalation part** is designed to evaluate safety and to select the **recommended Phase 2 dose (RP2D)** of Nana-val in patients with **recurrent or metastatic** (R/M) **Epstein-Barr virus-positive** (**EBV+**) nasopharyngeal carcinoma (NPC)[10](index=10&type=chunk) - At the start of Phase 2, up to **40 patients** with R/M **EBV+** NPC will be randomized to receive either the **RP2D** or a dose level below the **RP2D** in a dose-optimization cohort. Once the **RP2D** has been confirmed, up to **60 patients** with R/M **EBV+** NPC will be randomized to receive Nana-val at the **RP2D** with or without pembrolizumab to further evaluate **antitumor activity**, safety and tolerability, pharmacokinetics, and potential pharmacodynamic biomarkers[10](index=10&type=chunk) - Additionally, patients with **other advanced EBV+ solid tumors** will be enrolled to receive Nana-val at the **RP2D** in a Phase 1b dose expansion cohort[10](index=10&type=chunk) [About Nana-val (Nanatinostat and Valganciclovir)](index=4&type=section&id=About%20Nana-val%20(Nanatinostat%20and%20Valganciclovir)) Nana-val is an **all-oral combination therapy** of nanatinostat, a selective HDAC inhibitor, and valganciclovir, an antiviral agent. It is designed to induce viral genes **epigenetically silenced** in **EBV-associated malignancies**, currently being investigated in **EBV+** lymphoma and solid tumors - Nanatinostat is an orally available **histone deacetylase (HDAC) inhibitor** 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**[11](index=11&type=chunk) - Nana-val is nanatinostat in combination with the **antiviral agent valganciclovir**, an **all-oral combination therapy**[11](index=11&type=chunk) - Currently being investigated in a **pivotal Phase 2 basket trial** (NAVAL-1) for R/R **EBV+** lymphoma and a **multinational Phase 1b/2 clinical trial** for R/M **EBV+** NPC and **other advanced EBV+ solid tumors**[11](index=11&type=chunk) [About Peripheral T-Cell Lymphoma (PTCL)](index=4&type=section&id=About%20Peripheral%20T-Cell%20Lymphoma) PTCL is a rare, aggressive group of T-cell lymphomas with poor outcomes for **relapsed/refractory** patients, especially those with **EBV+** disease, representing a **high unmet medical need** due to the lack of approved targeted treatments - T-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)**[12](index=12&type=chunk) - **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[12](index=12&type=chunk) - **Approximately 70%** of these patients are either **refractory to first-line therapy** or eventually experience relapse, with poor outcomes for R/R PTCL (**median progression-free survival 3.7 months**, **median overall survival 6.5 months**)[12](index=12&type=chunk) - **Approximately 40% to 65%** of PTCL is associated with **EBV**; 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**, representing a **high unmet medical need**[12](index=12&type=chunk) [About EBV-Associated Cancers](index=4&type=section&id=About%20EBV-Associated%20Cancers) **Epstein-Barr virus** (**EBV**) infects about **90%** of adults globally, remaining latent and increasing susceptibility to **malignant transformation**. It is associated with **approximately 2%** of the **global cancer burden**, including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer - **Approximately 90%** of the world's adult population is infected with **EBV**. Following infection, the virus remains **latent in a small subset of cells** for the duration of the patient's life, making cells containing latent virus increasingly susceptible to **malignant transformation**[13](index=13&type=chunk) - Patients who are **immunocompromised** are at an increased risk of developing **EBV-positive** (**EBV+**) lymphomas[13](index=13&type=chunk) - **EBV** is estimated to be associated with **approximately 2%** of the **global cancer burden** including **lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer**[13](index=13&type=chunk) [Company Information](index=4&type=section&id=About%20Viracta%20Therapeutics%2C%20Inc.) [About Viracta Therapeutics, Inc.](index=4&type=section&id=About%20Viracta%20Therapeutics%2C%20Inc.) Viracta Therapeutics is a **clinical-stage precision oncology company** focused on **treating and preventing virus-associated cancers** globally. Its lead product candidate, Nana-val, an **all-oral combination therapy**, is being evaluated in **pivotal trials** for **EBV+** lymphoma and solid tumors, with plans to apply its **'Kick and Kill' approach** to other virus-related cancers - Viracta is a **clinical-stage precision oncology company** focused on the **treatment and prevention of virus-associated cancers** that impact patients worldwide[14](index=14&type=chunk) - 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)[14](index=14&type=chunk) - Nana-val is currently being evaluated in multiple **ongoing clinical trials**, including a **pivotal, 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**[14](index=14&type=chunk)[15](index=15&type=chunk) - Viracta is also pursuing the **application of its 'Kick and Kill' approach** in other virus-related cancers[15](index=15&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) [Forward-Looking Statements Disclaimer](index=5&type=section&id=Forward-Looking%20Statements%20Disclaimer) This section contains **forward-looking statements** regarding Viracta's **clinical trials, regulatory processes, patient populations, and cash runway**, highlighting **risks and uncertainties that could cause actual results to differ materially**, including **enrollment challenges, development plans, data timing, manufacturing capabilities, and future financing needs**, and the company **disclaims any obligation to update these statements except as required by law** - This communication contains **'forward-looking' statements** regarding details, timeline, and expected progress for Viracta's **ongoing and anticipated clinical trials**, FDA submission process and timelines, target patient populations, and expectations regarding **cash runway**[16](index=16&type=chunk) - **Risks and uncertainties that may cause actual results to differ materially** include **Viracta's ability to successfully enroll patients and complete clinical trials**, **plans to develop and commercialize product candidates**, **timing of trial initiation and data availability**, previous preclinical and clinical results not being predictive, **timing of IND/NDA**, **ability to manufacture or supply drugs**, and **estimates regarding funding ongoing operations, future expenses, capital requirements, and need for additional financing**[16](index=16&type=chunk) - **Additional risks and uncertainties** are included under the caption 'Risk Factors' in Viracta's **reports and other documents filed with the SEC**[17](index=17&type=chunk) - Viracta **assumes no obligation and does not intend to update these forward-looking statements**, **except as required by law or applicable regulation**[18](index=18&type=chunk)

Clinical Trials and Product Development - Viracta's lead product candidate, Nana-val, is currently being investigated in multiple ongoing clinical trials, including the NAVAL-1 trial for relapsed/refractory EBV+ lymphoma[84]. - In June 2023, Viracta announced that the efficacy threshold was reached in the NAVAL-1 trial for expansion into Stage 2 for patients with R/R EBV+ peripheral T-cell lymphoma[86]. - In October 2023, Viracta reported two confirmed partial responses and five stable diseases in 17 patients enrolled in the Phase 1b/2 trial for R/M EBV+ nasopharyngeal carcinoma[89]. - The company anticipates initiating the Phase 2 portion of the trial for R/M EBV+ NPC in 2024, with up to 60 patients randomized to receive Nana-val[90]. - The company is evaluating strategic partnerships for its pipeline products, vecabrutinib and VRx-510, in multiple oncology indications[84]. Financial Performance and Expenses - General and administrative expenses are expected to increase as Viracta prepares for potential commercialization of Nana-val and compliance with SEC requirements[97]. - Research and development expenses primarily include clinical and regulatory-related costs, with significant costs incurred for the development of Nana-val[93]. - Research and development expenses increased by approximately $1.0 million to $8.2 million for the three months ended September 30, 2023, compared to $7.1 million in the same period of 2022, primarily due to costs associated with clinical development programs[105]. - General and administrative expenses decreased by approximately $6.6 million to $4.3 million for the three months ended September 30, 2023, compared to $10.9 million in the same period of 2022, largely due to non-cash share-based compensation expenses[106]. - As of September 30, 2023, the company had an accumulated deficit of $252.2 million and expects to continue incurring net losses and operating cash outflows for at least the next several years[109]. - Cash, cash equivalents, and short-term investments totaled $63.0 million with working capital of $28.0 million as of September 30, 2023[109]. - Net cash used in operating activities was $29.9 million for the nine months ended September 30, 2023, compared to $27.6 million for the same period in 2022[114]. - Net cash provided by investing activities was $5.7 million for the nine months ended September 30, 2023, a significant improvement from $53.7 million used in the same period of 2022[115]. - The company sold 56,700 shares of common stock for $0.1 million at a weighted average price of $2.32 per share during the nine months ended September 30, 2023[110]. - Future funding requirements will depend on ongoing development activities and the ability to generate adequate revenues to support operations[117]. - The company may need to raise additional capital through equity or debt financing, which could dilute existing shareholders or impose operational restrictions[119]. Impact of External Factors - Viracta's business operations are being impacted by global events, including the COVID-19 pandemic and economic uncertainties, which may affect development timelines[91]. - The company has taken measures to mitigate the impact of the COVID-19 pandemic on its clinical trials, although the full extent of potential delays remains uncertain[92]. Agreements and Market Risks - The company has entered into short-term agreements with clinical sites and CROs for research studies, which are generally cancellable with prior notice[120]. - On March 22, 2021, the company entered into a royalty purchase agreement with XOMA (US) LLC, receiving an upfront payment of $13.5 million[121]. - The company is eligible to receive up to $20.0 million in pre-commercialization, event-based milestones under the royalty purchase agreement[121]. - The company is exposed to market risks, primarily including interest rate sensitivities related to short-term investments and outstanding loans[122].