Aankondiging • Jul 04
Nasdaq to Delist Common Stock of Viracta Therapeutics The Nasdaq Stock Market announced that it will delist the common stock of Viracta Therapeutics, Inc. Viracta Therapeutics’s stock was suspended on February 4, 2025 and has not traded on Nasdaq since that time. Aankondiging • Feb 04
Viracta Therapeutics, Inc.(OTCPK:VIRX) dropped from NASDAQ Composite Index Viracta Therapeutics, Inc. has been drtopped from the NASDAQ Composite Index . Aankondiging • Feb 01
Nasdaq to Suspend Trading in Viracta Therapeutics Common Stock Effective February 4, 2025 On January 31, 2025, Viracta Therapeutics, Inc. received written notification (the Delisting Notice") from The Nasdaq Stock Market LLC (Nasdaq") that the Company's common stock will be delisted from Nasdaq and trading in the Company's shares will be suspended at the open of trading on February 4, 2025. As previously reported, on May 28, 2024, the Company received a notification from the Listing Qualifications Staff of Nasdaq notifying the Company that it no longer complied with the $1.00 per share minimum requirement for continued listing under Nasdaq Listing Rule 5450(a)(1). Also as previously reported, on November 21, 2024, the Company received an additional notification from the Listing Qualifications Staff of Nasdaq notifying the Company that its amount of stockholders' equity had fallen below the $2,500,000 minimum requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1), or the alternatives of market value of listed securities or net income from continuing operations. In connection with the delisting and suspension, the Company expects that Nasdaq will file a Form 25 with the Securities and Exchange Commission (the SEC") in accordance with Nasdaq Listing Rule 5830 and Rule 12d2-2 promulgated under the Securities Exchange Act of 1934, as amended, after applicable appeal periods have lapsed. As a result of the suspension in trading and expected delisting, the Company expects that its common stock will begin trading publicly on the OTC Pink Open Market under its existing symbol VIRX". The OTC Pink Open Market is a significantly more limited market than the Nasdaq, and quotation on the OTC Pink Open Market will likely result in a less liquid market for existing and potential holders of the Company's common stock to trade such securities and could further depress the trading price of the common stock. The Company can provide no assurance that its common stock will continue to trade on this market, whether broker-dealers will continue to provide public quotes of its common stock on this market, or whether the trading volume of its common stock will be sufficient to provide for an efficient trading market for existing and potential holders of its common stock. Aankondiging • Dec 27
Viracta Therapeutics, Inc. Announces Closure of NAVAL-1 Clinical Trial and Exploration of Strategic Alternatives Viracta Therapeutics, Inc. 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 trial of Nana-val in relapsed/refractory EBV+ lymphomas (the NAVAL-1 trial). The company emphasized that its decision to voluntarily close the trial is not the result of any new safety finding. Viracta is making this announcement to inform shareholders and the public that the Company is engaging in discussions for strategic alternatives with the goal of maximizing value. Potential alternatives include, but are not limited to, a merger, licensing agreement, sale or other strategic transaction. Aankondiging • Dec 01
The Listing Qualifications Department of the Nasdaq Stock Market Issues a Delist Determination to Viracta Therapeutics As previously reported by Viracta Therapeutics, Inc. on its Current Report on Form 8-K filed on May 31, 2024, the Company received a notification letter, dated May 28, 2024, from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”), indicating that, based on the previous 30 consecutive business days, the Company’s listed shares no longer met the minimum $1.00 bid price per share requirement for the continued listing on The Nasdaq Capital Market, as set in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company had a period of 180 calendar days from May 28, 2024, or until November 25, 2024 (“Compliance Date”), to regain compliance with the Minimum Bid Price Requirement. As also previously disclosed by the Company on its Current Report on Form 8-K filed on November 22, 2024, the Company received a notification letter from the Staff on November 21, 2024, stating that it was not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires companies listed on the Nasdaq Capital Market to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing (the “Stockholders’ Equity Requirement”). On November 26, 2024, the Staff issued a delist determination to the Company (the “Delisting Notice”), indicating that the Company did not satisfy the Minimum Bid Price Requirement by the Compliance Date. The Delisting Notice indicated that the Company was not eligible for a second 180-day extension because it did not comply with the Stockholders’ Equity Requirement. The Company intends to request a hearing (the “Hearing”) before the Nasdaq Listing Qualifications Panel (the “Panel”) to appeal (the “Appeal”) the determination by the Staff, and to present its plan to regain and sustain compliance with the Minimum Bid Price Requirement and the Stockholders’ Equity Requirement. The Appeal will stay any delisting or suspension action of the Company’s listed shares contemplated by the Delisting Notice. The Panel can grant the Company a period not to exceed 180 calendar days from November 26, 2024, to regain compliance. There is no guarantee that the Panel will grant an extension of the compliance period or that the outcome of the Hearing or the Appeal will be favorable to the Company. Aankondiging • Nov 24
Viracta Therapeutics Receives Written Notice from Nasdaq Regarding Non-Compliance with the Minimum Stockholder Equity Requirement On November 21, 2024, Viracta Therapeutics, Inc. (the ‘Company’) received a written notice (the ‘Notice’) from the Nasdaq Listing Qualifications staff of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that its amount of stockholders’ equity has fallen below the $2,500,000 minimum requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1) (the ‘Minimum Stockholder Equity Requirement’). Nasdaq’s determination was based upon the Company’s stockholders’ equity as reported in the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2024. The Notice also noted that the Company does not meet the alternatives of market value of listed securities or net income from continuing operations. As stated in the Notice, the Company has until January 6, 2025 to provide Nasdaq with a plan to achieve and sustain compliance with the Minimum Stockholder Equity Requirement (the ‘Compliance Plan’). If Nasdaq accepts the Compliance Plan, Nasdaq may grant an extension of up to 180 calendar days from the date of the Notice to evidence compliance with the Minimum Stockholder Equity Requirement. If Nasdaq does not accept the Compliance Plan, then the Nasdaq staff will provide written notification to the Company that its common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel, which would stay all further actions. The Company intends to submit the Compliance Plan to Nasdaq, within the required time period. There can be no assurance that Nasdaq will accept the Compliance Plan, the Company will be able to regain compliance with Listing Rule 5550(b)(1) or maintain compliance with any other Nasdaq requirement in the future. The Company, by filing this Form 8-K, discloses its receipt of the notification from Nasdaq in accordance with Listing Rule 5810(b). New Risk • Aug 28
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$8.80m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$38m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (US$8.80m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$40m net loss in 3 years). Shareholders have been diluted in the past year (2.2% increase in shares outstanding). New Risk • Aug 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$37m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$37m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$67m net loss in 3 years). Market cap is less than US$100m (US$14.9m market cap). Aankondiging • Aug 14
Viracta Therapeutics Announces Positive Data from the Phase 2 NAVAL-1 Trial, Regulatory Progress, and Updated Nana-val Clinical Development Plan Viracta Therapeutics, Inc. 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. Key Takeaways from the R/R EBV+ PTCL Cohort of the Phase 2 NAVAL-1 Trial: Overview: 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 Steps - Based 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. 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. New Risk • Jun 14
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.9% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings are forecast to decline by an average of 0.9% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$87m net loss in 3 years). Shareholders have been diluted in the past year (2.2% increase in shares outstanding). Market cap is less than US$100m (US$25.2m market cap). Aankondiging • Jun 01
Viracta Therapeutics Receives Written Notice from Nasdaq Regarding Non-Compliance with Minimum Bid Price Requirement for Continued Listing under Nasdaq Listing Rule 5450(a)(1) On May 28, 2024, Viracta Therapeutics, Inc. (the ‘Company’) received a written notice (the ‘Notice’) from the Nasdaq Listing Qualifications staff of The Nasdaq Stock Market LLC (‘Nasdaq’) indicating that, for the last 30 consecutive business days, the minimum bid price of the Company’s common stock had been below the $1.00 per share minimum requirement for continued listing on the Nasdaq Global Select Market under Nasdaq Listing Rule 5450(a)(1) (the ‘Minimum Bid Price Requirement’). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until November 25, 2024, to regain compliance with the Minimum Bid Price Requirement. The Notice states that the Nasdaq staff will provide written notification that the Company has achieved compliance with Rule 5450(a)(1) if, at any time before November 25, 2024, the closing bid price of the Company’s common stock is $1.00 per share or more for a minimum of ten consecutive business days. The Notice has no immediate effect on the listing or trading of the Company’s common stock. In the event the Company does not regain compliance with the Minimum Bid Price Requirement by November 25, 2024, the Company may be eligible for additional time to regain compliance. To qualify, the Company must submit an application to transfer to The Nasdaq Capital Market, which would require the Company to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, the Company will be granted an additional 180 calendar days to regain compliance. If the Company does not qualify for or fails to regain compliance during the second compliance period, then the Nasdaq staff will provide written notification to the Company that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. The Company intends to actively monitor the closing bid price of its common stock and consider its available options to regain compliance with the Minimum Bid Price Requirement. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period ending November 25, 2024, secure an extension of the compliance period beyond November 25, 2024, or maintain compliance with any other Nasdaq listing requirements. Aankondiging • May 15
Viracta Therapeutics, Inc. Appoints Michael Faerm as Chief Financial Officer Viracta Therapeutics, Inc. announced the appointment of Michael Faerm as Chief Financial Officer, effective immediately. Mr. Faerm is a seasoned biotech executive with more than 25 years of experience in life sciences companies, equity research and investment banking. Mr. Faerm most recently served as Interim Chief Financial Officer at Harpoon Therapeutics, Inc., which was acquired by Merck for approximately $680 million, and where he helped lead a $150 million PIPE financing. Prior to Harpoon, Mr. Faerm was the Chief Financial Officer of Artiva Biotherapeutics, Inc., where he led financial strategy and operations, and oversaw the company’s investor relations, financial planning, accounting and facilities functions. Previously, Mr. Faerm served as a consulting and interim Chief Financial Officer and Chief Business Officer for numerous biopharma companies. Prior to this, Mr. Faerm served as the Chief Business Officer of Innoviva, Inc. (formerly Theravance, Inc.), and earlier, worked in business development and strategic finance roles at Forest Laboratories and Regeneron Pharmaceuticals. Mr. Faerm’s Wall Street experience includes Credit Suisse and Wells Fargo Securities, where he was a senior equity research analyst covering the pharmaceutical sector, and Merrill Lynch, where he was an investment banker executing a wide range of strategic and capital markets transactions in biopharma and other healthcare sectors. Mr. Faerm earned his MBA from Harvard Business School, an M.S. in civil engineering from Stanford University, and a B.S. in civil engineering from Columbia University. Aankondiging • Apr 28
Viracta Therapeutics, Inc., Annual General Meeting, Jun 18, 2024 Viracta Therapeutics, Inc., Annual General Meeting, Jun 18, 2024, at 09:30 Pacific Standard Time. Agenda: To elect four Class III directors to hold office until 2027 annual meeting of stockholders and until their respective successors are elected and qualified; to approve, on an advisory basis, the compensation of named executive officers; to ratify the appointment of Ernst & Young LLP as independent registered public accounting firm for fiscal year ending December 31, 2024; and to transact other business that may properly come before the Annual Meeting or any adjournments or postponements thereof. Board Change • Apr 19
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 9 experienced directors. 1 highly experienced director. CEO, President & Director Mark Rothera was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Apr 17
Viracta Therapeutics, Inc. Reports Positive Topline Results from Stage 1 of the Pivotal Phase 2 NAVAL-1 Trial Viracta Therapeutics, Inc. reported positive topline results from Stage 1 of the pivotal Phase 2 NAVAL-1 trial from both arms of the relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) cohort. Patients were randomized to either nanatinostat monotherapy (n=10) or to nanatinostat in combination with valganciclovir (Nana-val, n=10). These data were featured in an oral presentation during the 2024 Joint Annual Congress of Taiwan Society of Blood and Marrow Transplantation and The Hematology Society of Taiwan. Key takeaways from the pivotal Phase 2 NAVAL-1 trial in patients with R/R EBV+ PTCL: Nana-val (nanatinostat in combination with valganciclovir) demonstrated greater efficacy than nanatinostat monotherapy and was generally well-tolerated. The median duration of response continues to mature. Overview: A total of 20 patients with primarily Stage III-IV disease (who had received =1 [median of 2] prior systemic PTCL therapies) were randomized (1:1) to receive nanatinostat (20 mg orally once daily, 4 days/week) alone or as Nana-val in combination with valganciclovir (900 mg orally once daily, 7 days/week). Patients who did not respond to nanatinostat monotherapy after 6 weeks of treatment were offered the opportunity to cross over to receive Nana-val. Efficacy was evaluated as of the February 7, 2024 data cutoff date. In the Nana-val arm, the overall response rate (ORR) was 50% and the complete response rate (CRR) was 20% in the intent-to-treat (ITT) population (N=10); the ORR was 71% and the CRR was 29% in the efficacy-evaluable population (N=7). In the nanatinostat monotherapy arm, the ORR and CRR were 10% and 0%, respectively, in the ITT population (N=10), and the ORR was 13% in the efficacy-evaluable population (N=8). Five nanatinostat monotherapy patients crossed over to receive Nana-val, two of whom remain on Nana-val treatment with stable disease as of the data cutoff. Safety was also evaluated as of the February 7, 2024 data cutoff date. The most common treatment-related adverse events in both treatment arms were thrombocytopenia, anemia, fatigue, decreased appetite, nausea, diarrhea, and weight loss. These adverse events were primarily mild to moderate in severity and generally manageable or reversible. Aankondiging • Apr 03
Viracta Therapeutics to Present Topline Nana-val Results from Stage 1 of the NAVAL-1 Trial at the 2024 Annual Congress of The Hematology Society of Taiwan Viracta Therapeutics, Inc. announced that topline results from Stage 1 of the NAVAL-1 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) peripheral T-cell lymphoma (PTCL) will be featured in an oral presentation during the 2024 Joint Annual Congress of Taiwan Society of Blood and Marrow Transplantation and The Hematology Society ofTaiwan. Details of the presentation are as follows: Title: A Global Phase 2 Trial of Nanatinostat in Combination with Valganciclovir in Patients with EBV-Positive (EBV+) Relapsed/Refractory Peripheral T-Cell Lymphomas (NAVAL-1): Format: Oral presentation. Presenting Author: Professor Hung Chang, M.D., principal investigator in the NAVAL-1 trial, Chief of the Hematology Division, Linkou Chang Gung Memorial Hospital and Visiting Scholar at UMass Memorial Health Care. Presentation Date and Time: April 13, at 10:12 a.m. China Standard Time (April 12, at 7:12 p.m. Pacific Daylight Time). New Risk • Mar 09
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 1.3% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$56m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (US$32.8m market cap). Price Target Changed • Jan 06
Price target decreased by 20% to US$7.00 Down from US$8.75, the current price target is an average from 4 analysts. New target price is 1,067% above last closing price of US$0.60. Stock is down 63% over the past year. The company is forecast to post a net loss per share of US$1.28 next year compared to a net loss per share of US$1.30 last year. Aankondiging • Jan 05
Viracta Therapeutics, Inc. Provides Clinical Update Viracta Therapeutics, Inc. provided a clinical update, including its roadmap for advancing Nana-val’s clinical development in 2024. Nana-val (nanatinostat in combination with valganciclovir), is the company’s all-oral investigational therapy targeting Epstein-Barr virus-associated cancers. Anticipated Key 2024 Milestones: Pivotal NAVAL-1 studyof Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphomas Complete enrollment of Stage 2 in the R/R EBV+ peripheral T-cell lymphoma (PTCL) cohort of patients treated with Nana-val (n=11) in the first quarter of 2024. Report Stage 1 data from both arms of the R/R EBV+ PTCL cohort (in patients treated with nanatinostat, with [n=10] or without [n=10] valganciclovir) in the first half of 2024. Meet with the U.S. Food and Drug Administration (FDA) to discuss additional requirements for accelerated approval by mid-2024. Enroll patients with R/R EBV+ PTCL into the post-Phase 2 expansion cohort to support potential accelerated approval. Present Stage 2 data from patients with R/R EBV+ PTCL in the second half of 2024. Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) and R/R EBV+ post-transplant lymphoproliferative disorder (PTLD) by year-end 2024. Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors (Study 301) Determine the recommended Phase 2 dose (RP2D) by investigating the novel split daily dosing (SDD) regimen at higher dose levels of Nana-val in the second half of 2024. Initiate a dose-optimization cohort to confirm the RP2D as part of the study’s Phase 2 expansion by year-end 2024. Recent Clinical Trial Updates: Pivotal NAVAL-1 study of Nana-val in patients with R/R EBV+ lymphomas Completed enrollment of Stage 1 in the R/R EBV+ PTCL cohort of patients, and enrollment into Stage 2 continues to accelerate, as nearly half of the Stage 2 patients have been enrolled. The protocol was amended 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. Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors (Study 301) Initiated enrollment of the sixth dose cohort of patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) evaluating the new SDD regimen. In December 2023, the FDA granted an orphan drug designation (ODD) to Nana-val for the treatment of NPC, the fifth ODD granted to Nana-val by the FDA and the seventh ODD for Nana-val globally. Confirmed partial responses without dose-limiting toxicities through the initial five dose cohorts. Further, new preclinical data presented at ESMO Asia Congress 2023 support continued dose-escalation to enhance Nana-val’s antitumor activity. Best responses through the fifth dose cohort included two confirmed partial responses and five stable diseases out of 17 patients. Aankondiging • Dec 04
Viracta Therapeutics Announces Interim Data from Phase 1B/2 Clinical Trial of Nana-Val in Patients with Epstein-Barr Virus-Positive Solid Tumors That Show Confirms Tumor Responses At Higher Dose Levels Viracta Therapeutics, Inc. announced that additional data from the Phase 1b/2 clinical trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with recurrent or metastatic (R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC) showed two ongoing confirmed partial responses (PRs) at higher dose levels. Planning for success, company incorporated FDA's Project Optimus initiative into the Phase 2 study design, which is intended to confirm the recommended Phase 2 dose of Nana-val that maximizes efficacy as well as safety and tolerability in patients with advanced EBV-positive solid tumors. This Phase 1b/2 trial (NCT05166577) is an open-label, multinational clinical trial evaluating Nana-val alone and in combination with pembrolizumab. Along with the U.S. Food and Drug Administration's Project Optimus initiative 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. Ongoing trials include a pivotal, 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 trials in patients with recurrent or metastatics (R/M) EBV+ NPC and other EBV+ solid tumors. Nana-val is currently being evaluated in multiple ongoing clinical trials, including a pivotal, global, multic enter-label, open-label Phase 1b/2 basket trial for the treatment of multiple sub types of relapsed or refractories (R/R) Epstein-Barr virus -positive (EBV+) lymphoma (NAval-1), as well as a multinational, open-label Phase 2 clinical trial for the treatment of patients with recurrent or metastatic ("R/M) EBV+) lymphoma (NAVAL- 1), as well as a multinational Phase 2 basket trial in patients with recurrent or metastatic (R/M") EBV+ NPC and other EBV+ solid tumors. NANA-val is currently being evaluated In multiple ongoing clinical trials, including an pivotal, global, multicenter. Aankondiging • Nov 19
Viracta Therapeutics, Inc. Receives A Written Notice from the Nasdaq Listing Qualifications Staff of the Nasdaq Stock Market LLC On November 15, 2023, Viracta Therapeutics, Inc. (the Company) received a written notice (the Notice) from the Nasdaq Listing Qualifications staff of The Nasdaq Stock Market LLC (Nasdaq) indicating that, for the last 30 consecutive business days, the minimum bid price of the Company's common stock had been below the $1.00 per share minimum requirement for continued listing on the Nasdaq Global Select Market under Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until May 13, 2024, to regain compliance with the Minimum Bid Price Requirement. The Notice states that the Nasdaq staff will provide written notification that the Company has achieved compliance with Rule 5550(a)(2) if, at any time before May 13, 2024, the closing bid price of the Company's common stock is $1.00 per share or more for a minimum of ten consecutive business days. The Notice has no immediate effect on the listing or trading of the Company's common stock. In the event the Company does not regain compliance with the Minimum Bid Price Requirement by May 13, 2024, the Company may be eligible for additional time to regain compliance. To qualify, the Company must submit an application to transfer to The Nasdaq Capital Market, which would require the Company to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, the Company will be granted an additional 180 calendar days to regain compliance. If the Company does not qualify for or fails to regain compliance during the second compliance period, then the Nasdaq staff will provide written notification to the Company that its common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. The Company intends to actively monitor the closing bid price of its common stock and consider its available options to regain compliance with the Minimum Bid Price Requirement. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during the 180-day compliance period ending May 13, 2024, secure an extension of the compliance period beyond May 13, 2024, or maintain compliance with any other Nasdaq listing requirements. New Risk • Nov 12
New major risk - Revenue and earnings growth Earnings have declined by 11% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 11% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (US$22.4m market cap). New Risk • Oct 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 9.2% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$64m net loss in 3 years). Share price has been volatile over the past 3 months (9.2% average weekly change). Shareholders have been diluted in the past year (2.7% increase in shares outstanding). Market cap is less than US$100m (US$30.3m market cap). Aankondiging • Aug 09
Viracta Therapeutics, Inc. Appoints Darrel P. Cohen, M.D., Ph.D. as Chief Medical Officer Viracta Therapeutics, Inc. announced the appointment of Darrel P. Cohen, M.D., Ph.D. as Chief Medical Officer (CMO), effective immediately. Dr. Cohen brings more than 25 years of global clinical research and drug development experience, having contributed to the successful regulatory submissions of multiple novel oncology therapies including SUTENT (sunitinib), XALKORI (crizotinib), and IBRANCE (palbociclib). Dr. Cohen will oversee the clinical development and regulatory advancement of Nana-val in Epstein-Barr virus (EBV)-associated malignances, contribute to the strategic expansion of Viractas pipeline, and serve on the Executive Leadership Team. Darrel is a highly accomplished physician and biopharmaceutical executive with an extraordinary depth of global clinical development and regulatory experience in both solid tumors and hematologic malignancies, having contributed to the approvals of multiple therapies across various oncology indications, said Mark Rothera, President and Chief Executive Officer of Viracta. Dr. Cohen is a hematologist/oncologist with more than 25 years of oncology clinical research and drug development experience. Most recently, Dr. Cohen was CMO of Cell Therapy at Athenex Inc., where he led clinical development, clinical operations, and regulatory affairs for its CAR-NKT cell therapy platform and was instrumental in accelerating clinical development plans for investigational products, KUR-501 and KUR-502. Prior to this, Dr. Cohen was CMO at Biosight Pharmaceuticals and Head of Clinical Development at EUSA Pharma. He has held leadership positions of increasing responsibility at Pharmacia, Sanofi-Aventis, and Pfizer, including Vice President of Late-Phase Clinical Development at Pfizer Oncology where he was involved in multiple successful regulatory submissions of new targeted cancer drugs such as SUTENT, XALKORI, and IBRANCE. Dr. Cohen received his M.D. and Ph.D. degrees in Medicine and Microbiology from Boston University School of Medicine, trained as a resident in Internal Medicine at Georgetown University Medical Center, and completed a fellowship in hematology/oncology at Duke University Medical Center. Price Target Changed • Jul 06
Price target decreased by 36% to US$9.40 Down from US$14.80, the current price target is an average from 5 analysts. New target price is 591% above last closing price of US$1.36. Stock is down 67% over the past year. The company is forecast to post a net loss per share of US$1.10 next year compared to a net loss per share of US$1.30 last year. Price Target Changed • Jun 29
Price target decreased by 9.1% to US$14.00 Down from US$15.40, the current price target is an average from 5 analysts. New target price is 866% above last closing price of US$1.45. Stock is down 63% over the past year. The company is forecast to post a net loss per share of US$1.10 next year compared to a net loss per share of US$1.30 last year. Aankondiging • Jun 29
Viracta Therapeutics’ Pivotal Naval-1 Trial Achieves Efficacy Threshold for Expansion in Relapsed or Refractory EBV-Positive Peripheral T-Cell Lymphoma Viracta Therapeutics, Inc. announced that the relapsed or refractory EBV+ peripheral T-cell lymphoma (R/R EBV+ PTCL) cohort of its pivotal NAVAL-1 clinical trial has met the pre-specified efficacy threshold for expansion into Stage 2 of the study. The efficacy threshold for expansion of NAVAL-1 cohorts from Stage 1 to Stage 2 is based upon a pre-specified minimum number of objective responses achieved within the first 10 patients enrolled. NAVAL-1 enrollment continues worldwide with updates on potential additional cohort advancements expected in the second half of 2023. Aankondiging • Jan 09
Viracta Therapeutics, Inc. Announces First Clinical Response in Epstein-Barr Virus-Positive (EBV+) Solid Tumor Setting and Outlines Key 2023 Clinical Objectives Viracta Therapeutics, Inc. announced new clinical data from the Phase 1b/2 trial of Nana-val in patients with EBV+ R/M NPC and other EBV+ solid tumors and outlined its key 2023 clinical objectives. New Phase 1b data on Nana-val in patients with EBV+ R/M NPC: One PR and one disease progression were reported in evaluable patients in the third dose level; Preliminary safety data from the first three dose levels was previously presented at the European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO) in December 2022, showing Nana-val was well-tolerated with no dose limiting toxicities; Enrollment in the fourth dose level is ongoing. Key 2023 Clinical Objectives: Nana-val in patients with EBV+ R/R lymphoma: Pivotal NAVAL-1 study open for enrollment at more than 60 sites globally; the study footprint is expected to expand further in 2023; Anticipate providing an update on NAVAL-1’s first lymphoma subtype that may advance from Stage 1 to Stage 2 in the first half of 2023; Expect to provide additional updates from other lymphoma subtype(s) throughout 2023. Nana-val in patients with advanced EBV+ solid tumors: Anticipate completion of the Phase 1b dose escalation portion of the trial and selection of the recommended Phase 2 dose (RP2D) in 2023; Anticipate initiating the Phase 2 randomized expansion portion of the trial, designed to evaluate Nana-val at the RP2D with or without pembrolizumab in patients with EBV+ R/M NPC, in the second half of 2023; Anticipate initiating the exploratory Phase 1b cohort designed to evaluate Nana-val at the RP2D in other EBV+ solid tumors in the second half of 2023. Cash Position and Anticipated Runway: Viracta strengthened its balance sheet by exercising its option to draw the $20 million tranche from its non-dilutive $50 million credit facility with Silicon Valley Bank (SVB) and Oxford Finance LLC (Oxford). Viracta intends to use this additional capital to support Nana-val’s development in EBV+ R/M NPC and to explore its potential in other advanced EBV+ solid tumor indications. As a result, Viracta ended 2022 with over $90 million in cash, cash equivalents, and investments, and has an anticipated cash runway into late 2024. 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 pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors. Price Target Changed • Nov 17
Price target decreased to US$15.00 Down from US$20.00, the current price target is an average from 5 analysts. New target price is 438% above last closing price of US$2.79. Stock is down 50% over the past year. The company is forecast to post a net loss per share of US$1.41 next year compared to a net loss per share of US$3.60 last year. Board Change • Nov 16
High number of new directors There are 5 new directors who have joined the board in the last 3 years. CEO, President & Director Mark Rothera was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Nov 01
High number of new directors There are 5 new directors who have joined the board in the last 3 years. CEO, President & Director Mark Rothera was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Oct 02
High number of new directors There are 5 new directors who have joined the board in the last 3 years. CEO, President & Director Mark Rothera was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Recent Insider Transactions Derivative • Aug 31
CEO, President & Director exercised options and sold US$54k worth of stock On the 26th of August, Ivor Royston exercised options to acquire 13k shares at no cost and sold these for an average price of US$4.01 per share. This trade did not impact their existing holding. For the year to December 2019, Ivor's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since December 2021, Ivor's direct individual holding has increased from 596.89k shares to 619.53k. Company insiders have collectively sold US$304k more than they bought, via options and on-market transactions in the last 12 months. Price Target Changed • Apr 27
Price target decreased to US$21.40 Down from US$28.80, the current price target is an average from 5 analysts. New target price is 726% above last closing price of US$2.59. Stock is down 74% over the past year. The company is forecast to post a net loss per share of US$1.24 next year compared to a net loss per share of US$3.60 last year. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there are only 5 independent directors on the board. The company's board is composed of: 5 independent directors. 6 non-independent directors. Independent Director Tom Darcy was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Price Target Changed • Feb 25
Price target increased to US$31.50 Up from US$28.80, the current price target is an average from 3 analysts. New target price is 1,017% above last closing price of US$2.82. Stock is down 79% over the past year. The company is forecast to post a net loss per share of US$3.63 next year compared to a net loss per share of US$6.55 last year. Recent Insider Transactions Derivative • Dec 01
CEO, President & Director exercised options and sold US$133k worth of stock On the 29th of November, Ivor Royston exercised options to acquire 28k shares at no cost and sold these for an average price of US$4.81 per share. This trade did not impact their existing holding. For the year to December 2020, Ivor's total compensation was 98% salary and 2% non-salary. Since March 2021, Ivor's direct individual holding has decreased from 5.00m shares to 567.20k. Company insiders have collectively sold US$79k more than they bought, via options and on-market transactions in the last 12 months.