Viracta Therapeutics, Inc. (Form: 8-K, Received: 08/23/2021 08:05:58)

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 19, 2021

VIRACTA THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)


Delaware	000-51531	94-3295878
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

2533 S. Coast Hwy. 101, Suite 210
Cardiff, California		92007
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (858) 400-8470

(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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	VIRX	The NASDAQ Stock Market LLC

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 August 19, 2021, Viracta Therapeutics, Inc., through its wholly owned subsidiary, Viracta Subsidiary, Inc., (collectively, “Viracta”) and Shenzhen Salubris Pharmaceutical Co. Ltd. (“Salubris”) entered into a Mutual Termination Agreement, effective August 20, 2021 (the “Termination Agreement”), pursuant to which the parties agreed to terminate the exclusive collaboration and license agreement entered into by the parties on November 30, 2018 (the “License Agreement), pursuant to which Viracta had granted Salubris an exclusive license, with the right to grant sublicenses, to Viracta’s patent and know-how rights to develop and commercialize nanatinostat in combination with an antiviral drug, such as valganciclovir, for treatment, prevention, or diagnosis of virus-associated malignancies in humans and non-humans in the Republic of China, excluding Hong Kong, Macau, and Taiwan. Under the terms of the Termination Agreement, Viracta paid Salubris a payment in the amount of $4,000,000 USD on the effective date of the Termination Agreement. Pursuant to the Termination Agreement, all licenses granted by Viracta to Salubris automatically terminated, and Salubris shall use commercially reasonable efforts to seek an orderly transition of the development and commercialization of Viracta’s technology, including the related data and regulatory filings, to Viracta.

The foregoing description of the Termination Agreement does not purport to be complete and is qualified in its entirety by reference to the text of the Termination Agreement, a copy of which is filed hereto as Exhibit 10.1 with this Current Report on Form 8-K.

Item 1.02 Termination of a Material Definitive Agreement.

The information contained in Item 1.01 of this Current Report on Form 8-K with respect to the termination of the License Agreement is incorporated by reference herein and made a part hereof.

Item 8.01 Other Events.

On August 23, 2021, Viracta issued a press release announcing entry into the Termination Agreement. A copy of such press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits



Exhibit Number		Description

10.1		Mutual Termination Agreement, by and between Viracta Subsidiary, Inc. and Shenzhen Salubris Pharmaceutical Co. Ltd.
99.1		Press Release, dated August 23, 2021
104		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 thereunto duly authorized.


			Viracta Therapeutics, Inc.

Date:	August 23, 2021	By:	/s/ Daniel Chevallard
			Daniel Chevallard Chief Operating Officer and Chief Financial Officer

Exhibit 10.1

MUTUAL TERMINATION AGREEMENT

THIS MUTUAL TERMINATION AGREEMENT (“Agreement”) is made and entered into this 20th day of August, 2021 (“Effective Date”), by and between Viracta Subsidiary, Inc. (formerly Viracta Therapeutics, Inc.), a Delaware corporation (“Viracta”), and Salubris Pharmaceutical Co. Ltd., a company organized under the laws of the People’s Republic of China (“Salubris”).

WHEREAS, Viracta and Salubris are parties to that certain Exclusive Collaboration and License Agreement, effective November 30, 2018 (“Original Agreement”); and

WHEREAS, Viracta and Salubris have mutually agreed to terminate the Original Agreement, on the terms and conditions set forth herein;

NOW, THEREFORE, in consideration of the foregoing recitals and the promises contained herein, the parties hereto agree as follows:

Payment. Within two (2) business days of the Effective Date, Viracta shall pay to Salubris in cash the amount of four million US dollars ($4,000,000.00) wire transfer in immediately available funds to an account designated by Salubris.

Termination. Effective as of the Effective Date, notwithstanding the provisions set forth in the Original Agreement, Salubris and Viracta agree that the Original Agreement shall be and is hereby deemed terminated and of no further force and effect. Viracta and Salubris further agree that, notwithstanding the provisions of Section 14.7 of the Original Agreement, only the following provisions of the Original Agreement shall survive termination: Section 2.5 (No Implied License), and Sections 14.4(a), (b) and (d) (Termination, in each case to the extent applicable), 14.5 (Confidential Information), 14.6 (Rights in Bankruptcy), and Articles 1 (Definitions), 12 (Indemnification), 13 (Confidentiality), 15 (Dispute Resolution), and 16 (Miscellaneous).

Effects of Termination. Following the termination on the Effective Date, the termination provisions set forth in Section 14.4 of the Original Agreement shall apply. In addition, within thirty (30) days of the Effective Date, Salubris shall transfer or cause to be transferred to Viracta, at Salubris’ expense, all Data (as defined in the Original Agreement) and all Regulatory Filings (as defined in the Original Agreement), if any, in Salubris’ reasonable control. Salubris shall use commercially reasonable efforts and shall execute all documents reasonably necessary to effectuate a transfer and assignment of such Data and Regulatory Filings to Viracta. Following such transfer, all such Data shall be the sole and exclusive property of Viracta. Following the termination, Salubris shall have no rights to any Data, whether created by Salubris, Viracta or jointly by the parties. Promptly following the Effective Date, at Viracta’s option, Salubris will either return to Viracta or destroy any CMC material in Salubris’ possession.

Mutual Release. Effective upon the Effective Date, each of Viracta and Salubris, on behalf of themselves and their respective affiliates, and each of their respective directors, officers, shareholders, members, employees and agents, and each of their respective heirs, administrators, successors and assigns (with respect to each party, collectively, a “Group”) hereby releases, waives, and forever discharges the other party and all of its affiliates and each of their respective directors,

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officers, shareholders, members, employees and agents, and each of their respective heirs, administrators, successors and assigns (collectively, the “Releasees”) from any and all claims, causes of action, suits, debts, demands, agreements, and promises, of whatever nature or kind, at law or in equity, such party or any other member of its Group now has, ever had or, but for this release, hereafter would or could have, against any Releasee, whether known or unknown, fixed or contingent, as a result of, arising directly or indirectly from or relating to (a) the Original Agreement based on occurrences on or before the Effective Date, or (b) any matter, negotiation, conversation, agreement, tort, action, inaction, disclosure, omission, event, or other occurrence, in each case, occurring at any time on or prior to the Effective Date, and (c) any and all liabilities, losses, costs and expenses related to any of the foregoing; provided, however, that it is understood that the foregoing release shall not apply to each party’s rights and obligations set forth in Sections 1 through 3 above.

Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as follows, as of the Effective Date:

(a)

it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated;

(b)

it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder;

(c)

it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder and the consummation of the transactions contemplated hereby; and

(d)

this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms.

Additional Representations and Warranties of Salubris. Salubris hereby represents and warrants to Viracta as follows, as of the Effective Date:

(e)

Other than the Data and Regulatory Filings being transferred to Viracta pursuant to this Agreement, there are no Know-How or Patent Rights owned or controlled by Salubris reasonably useful or necessary for the research, Development, manufacture, preparation, use or Commercialization of the Drug Candidate or the Products in the Field; and

(f)

Salubris has not granted any liens, security interests or other encumbrances on the Licensed Technology.

No Disparagement. Each of Viracta and Salubris agrees that it will not in any way disparage the other party or any related companies, or their respective current or former officers, agents, directors, supervisors, shareholders, employees, attorneys, representatives, successors or assigns.

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Publicity; Public Disclosures. The Parties agree that Viracta may issue a press release substantially in a form agreed by the Parties and attached to this Agreement as Exhibit A announcing the signature of this Agreement at or shortly after the Effective Date within the time period as required by relevant securities laws. It is understood that each Party may desire or be required to issue subsequent disclosures relating to this Agreement or activities hereunder. Either Party may make such disclosures to the SEC or other applicable agency as it determines, based on advice of counsel, is reasonably necessary to comply with Applicable Laws or for appropriate market disclosure. Each Party shall have the right to make any such filing as it reasonably determines necessary under Applicable Laws. In addition, following the initial press release by Viracta announcing this Agreement, either Party shall be free to disclose, without the other Party’s prior written consent, the existence of this Agreement, the identity of the other Party and those terms of the Agreement which have already been publicly disclosed in accordance with this Section 8.

Governing Law. This Agreement shall be construed in accordance with and governed by the laws of Hong Kong, without regard to the conflict of law principles thereof.

10.

Waiver; Amendment. No waiver by any party of any breach of any term or provision of this Agreement shall be construed to be, nor be, a waiver of any preceding, concurrent or succeeding breach of this Agreement or of any other term or provision of this Agreement. No waiver shall be binding on the part of any party unless set forth in a writing signed by such party. This Agreement may not be modified except by a written agreement signed by an authorized representative of each party.

11.

Entire Agreement. This Agreement contains all of the terms and conditions agreed upon by the parties regarding the subject matter of this Agreement and supersedes and replaces any and all prior or contemporaneous agreements, promises, negotiations, or representations, either oral or written, concerning the subject matter of this Agreement.

12.

Successors and Assigns. This Agreement shall be binding upon the parties hereto and upon their heirs, administrators, representatives, executors, successors, and assigns, and shall inure to the benefit of said parties and each of their respective heirs, administrators, representatives, executors, successors, and assigns.

13.

Counterparts. This Agreement may be executed in two (2) or more counterparts, in original, facsimile, PDF, or other electronic format, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

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IN WITNESS WHEREOF, the parties have executed this Termination Agreement on the Effective Date.

SALUBRIS PHARMACEUTICAL CO. LTD.

By: /s/ Kevin Ye_____________

Title: _CEO___________________

VIRACTA SUBSIDIARY, INC.

By: _/s/ Ivor Royston________

Title: _CEO________________

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EXHIBIT A

Viracta Press Release

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Exhibit 99.1

Viracta Therapeutics Reacquires Exclusive Development and Commercialization Rights for its All-Oral Combination Therapy in China

Viracta now controls global rights to its all-oral combination regimen of nanatinostat and valganciclovir

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

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

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

About Nanatinostat

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

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About Viracta Therapeutics, Inc.

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

For additional information please visit www.viracta.com.

Forward-Looking Statements

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

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

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

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Investor Relations Contact:	Viracta Contact:
Joyce Allaire	Dan Chevallard
LifeSci Advisors	Chief Operating Officer and Chief Financial Officer
jallaire@lifesciadvisors.com	dchevallard@viracta.com
(212) 915-2569	(858) 771-4193

SOURCE Viracta Therapeutics, Inc.

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