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Share Name | Share Symbol | Market | Type |
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Viracta Therapeutics Inc | NASDAQ:VIRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.52 | 0.5027 | 0.649 | 0 | 09:00:00 |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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(Exact name of Registrant as Specified in Its Charter)
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01 Entry into a Material Definitive Agreement.
On March 4, 2024, the Company entered into an Amendment No. 1 (the “Day One Amendment”) to the License Agreement for RAF, dated as of December 16, 2019, by and between the Company and Day One Biopharmaceuticals, Inc., successor in interest to DOT Therapeutcs-1, Inc., to monetize a pre-commercialization, event-based milestone for $5.0 million to be received in March 2024, thereby reducing the milestone percentage under the agreement.
On March 4, 2024, in connection with the entry into the Day One Amendment, the Company entered into an Amendment No. 1 (the “XOMA Amendment”) to the Royalty Purchase Agreement, dated as March 22, 2021, by and between the Company and XOMA (US) LLC, modifying the economic value-share under the Royalty Purchase Agreement, by which the Company has retained the right, under certain circumstances, to participate in a pre-commercialization, event-based milestone up to $5.0 million.
On March 1, 2024, the Company entered into a Second Amendment (the “Second Amendment”) to the Loan and Security Agreement by and among the Company and Silicon Valley Bank, now a division of First-Citizens Bank and Trust Company, and Oxford Finance LLC, dated November 4, 2021, as previously amended, 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 the term loan. Pursuant to the terms of the Second Amendment, the Company has agreed to remit a prepayment of $5.0 million toward the outstanding principal, plus a pro rata portion of the final payment, by March 15, 2024. Under the terms of the Second Amendment, principal amortization will be deferred between March 2024 and June 2024, and during such time we will be required to make payments of interest-only. Principal amortization payments will recommence in July 2024, followed by 29 equal monthly payments of principal plus accrued interest through maturity. There were no changes to the maturity date of the term loan.
The foregoing descriptions of the Day One Amendment, the XOMA Amendment and the Second Amendment are not complete and each is qualified in its entirety by reference to the full text of such amendments, copies of each of which will be filed as exhibits to the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Item 2.02 Results of Operations and Financial Condition.
On March 7, 2024, Viracta Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended December 31, 2023. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and the press release attached hereto as Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit Number |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Viracta Therapeutics, Inc |
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Date: |
March 7, 2024 |
By: |
/s/ Daniel Chevallard |
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Daniel Chevallard |
Exhibit 99.1
Viracta Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
Completed Stage 2 enrollment in the NAVAL-1 trial of Nana-val in patients with relapsed or refractory EBV+ peripheral T-cell lymphoma supporting its speed to market strategy; topline results from Stage 1 of the study expected in the second quarter of 2024
Completed enrollment into first split daily dosing cohort of the Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors
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
San Diego, March 7, 2024 – 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 fourth quarter and full-year of 2023 and provided a business update.
“Nana-val is a first-in-class, all-oral combination treatment regimen that has entered late-stage development to target and treat EBV-associated cancers. Our near-term goal is to address the high unmet medical need of patients living with relapsed or refractory EBV-positive PTCL by advancing Nana-val in this lead indication through regulatory approval as quickly as possible,” said Mark Rothera, President and Chief Executive Officer of Viracta. “We are pleased to have successfully completed patient enrollment across both Stage 1 and Stage 2 of the PTCL cohort in our pivotal NAVAL-1 trial. Building on this momentum, we anticipate reporting topline data from Stage 1 in the second quarter of 2024 and engaging with the FDA on a potential accelerated approval pathway in mid-2024.”
Clinical Trial Updates and Anticipated Milestones
Pivotal 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:
Anticipated 2024 Milestones:
Page | 1
Exhibit 99.1
Phase 1b/2 trial of Nana-val in patients with recurrent/metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors (Study 301)
Clinical Trial Updates:
Anticipated 2024 Milestones:
Business Updates
“We are pleased to have strengthened our balance sheet through the imminent receipt of $5 million in non-dilutive capital at this important time,” said Dan Chevallard, Chief Operating Officer and Chief
Page | 2
Exhibit 99.1
Financial Officer of Viracta. “The proceeds will be used to make a partial prepayment of our outstanding debt balance, while also enabling a concurrent amendment to our credit facility to avail ourselves of an additional interest-only period through June 2024, and further reduce future amortization and interest payments reflecting the prepayment. Pro forma for this prepayment, we will have reduced our debt balance by over 25% since year-end to $18.6M and anticipate ending 2024 with less than $15 million in debt outstanding. The totality of this coordinated set of transactions will extend our cash runway into mid-Q1 2025 and provides a meaningful aggregate cash impact to Viracta well in excess of the proceeds.”
Fourth-Quarter and Full-Year 2023 Financial Results
About the NAVAL-1 Trial
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. 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 the Phase 1b/2 Study of Nana-val in Patients with Advanced EBV+ Solid Tumors (Study 301)
This Phase 1b/2 trial (NCT05166577) is an open-label, multinational clinical trial evaluating Nana-val alone and in combination with pembrolizumab. 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
Page | 3
Exhibit 99.1
(R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC). 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. 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. 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.
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 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 Lymphoma
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). 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 Cancers
Approximately 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 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
Page | 4
Exhibit 99.1
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 Statements
This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the details, timeline and expected progress for Viracta's ongoing and anticipated clinical trials and updates regarding the same, the Company’s expectations related to the FDA submission process and timelines, expectations regarding our target patient populations, and expectations regarding our 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:
Ashleigh Barreto
Head of Investor Relations & Corporate Communications
Viracta Therapeutics, Inc.
abarreto@viracta.com
SOURCE Viracta Therapeutics, Inc.
-- Financial tables attached –
Page | 5
Exhibit 99.1
Viracta Therapeutics, Inc. |
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Selected Balance Sheet Highlights |
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(in thousands) |
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December 31, |
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December 31, |
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2023 |
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2022 |
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Cash, cash equivalents and short-term investments |
$ |
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53,691 |
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$ |
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91,043 |
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Total assets |
$ |
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56,692 |
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$ |
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95,991 |
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Total liabilities |
$ |
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38,373 |
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$ |
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34,888 |
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Stockholders' equity |
$ |
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18,319 |
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$ |
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61,103 |
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Viracta Therapeutics, Inc. |
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Condensed Consolidated Statement of Operations and Comprehensive Loss |
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(in thousands except share and per share data) |
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Three Months Ended December 31, |
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Year Ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
$ |
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9,406 |
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$ |
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6,703 |
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$ |
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33,369 |
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$ |
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26,262 |
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General and administrative |
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4,154 |
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4,871 |
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17,324 |
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24,327 |
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Total operating expenses |
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13,560 |
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11,574 |
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50,693 |
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50,589 |
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Loss from operations |
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(13,560 |
) |
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(11,574 |
) |
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(50,693 |
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(50,589 |
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Total other income (expense) |
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(205 |
) |
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1,248 |
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(365 |
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1,392 |
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Net loss |
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(13,765 |
) |
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(10,326 |
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(51,058 |
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(49,197 |
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Unrealized gain (loss) on short-term investments |
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73 |
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21 |
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187 |
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(178 |
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Comprehensive loss |
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(13,692 |
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(10,305 |
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(50,871 |
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(49,375 |
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Net loss per share, basic and diluted |
$ |
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(0.35 |
) |
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$ |
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(0.27 |
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$ |
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(1.32 |
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$ |
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(1.30 |
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Weighted-average common shares |
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38,790,480 |
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38,315,658 |
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38,624,462 |
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37,790,981 |
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Page | 6
Document And Entity Information |
Mar. 01, 2024 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Mar. 01, 2024 |
Entity Registrant Name | Viracta Therapeutics, Inc. |
Entity Central Index Key | 0001061027 |
Entity Emerging Growth Company | false |
Entity File Number | 000-51531 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 94-3295878 |
Entity Address, Address Line One | 2533 S. Coast Hwy. 101, Suite 210 |
Entity Address, City or Town | Cardiff |
Entity Address, State or Province | CA |
Entity Address, Postal Zip Code | 92007 |
City Area Code | (858) |
Local Phone Number | 400-8470 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common Stock, par value $0.0001 per share |
Trading Symbol | VIRX |
Security Exchange Name | NASDAQ |
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