VIRX Viracta Therapeutics Inc

 

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 04, 2023

 

 

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:

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. ☐

 

 

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Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Appointment of Chief Medical Officer

On August 4, 2023, the Board of Directors (“Board”) of Viracta Therapeutics, Inc. (the “Company”) appointed Darrel P. Cohen M.D., Ph.D. to serve as Chief Medical Officer of the Company, effective August 7, 2023.

Dr. Cohen, age 58, is a hematologist/oncologist with over 25 years of oncology clinical research and drug development experience. Most recently, from June 2022 to May 2023, Dr. Cohen was Chief Medical Officer of Cell Therapy at Athenex Inc., a clinical-stage biotechnology company, where he led clinical development, clinical operations, and regulatory affairs for its CAR-NKT cell therapy platform. Prior to this, from May 2021 to October 2021, Dr. Cohen was Chief Medical Officer at Biosight Pharmaceuticals, a clinical-stage hemato-oncology company. Prior to Biosight, from May 2019 to April 2021, Dr. Cohen was Head of Clinical Development at EUSA Pharma, a global specialty biopharmaceutical company. Prior to EUSA Pharma, from August 2006 to May 2019, Dr. Cohen held leadership positions of increasing responsibility at Pfizer Oncology, a global biopharmaceutical company, including Vice President of Late-Phase Clinical Development, where he was involved in multiple successful regulatory submissions of new targeted cancer drugs such as SUTENT® (sunitinib), XALKORI® (crizotinib), and IBRANCE® (palbociclib). 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.

Dr. Cohen has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K promulgated under the Securities Exchange Act of 1934, as amended, nor are any such transactions currently proposed. There is no arrangement or understanding between Dr. Cohen or any other person pursuant to which Dr. Cohen was selected as an officer or director. There are no family relationships between Dr. Cohen and any of the Company’s directors or executive officers.

 

Item 7.01. Regulation FD Disclosure.

On August 7, 2023, the Company issued a press release announcing the appointment of Darrel P. Cohen M.D., Ph.D. as Chief Medical Officer. A copy of that press release is furnished herewith as Exhibit 99.1.

The information set forth under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit		Description
99.1		Press Release dated August 7, 2023
104		The cover page of this Current Report on Form 8-K, formatted in Inline XBRL

 

 

 

 

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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 7, 2023	By:	/s/ Daniel Chevallard
			Daniel Chevallard Chief Operating Officer and Chief Financial Officer

 

 

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Exhibit 99.1

Viracta Therapeutics Appoints Darrel P. Cohen, M.D., Ph.D. as Chief Medical Officer

 

SAN DIEGO, Calif., August 7, 2023 – Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced 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 Viracta’s 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. “We are thrilled with the recent advancement of Nana-val in our pivotal NAVAL-1 lymphoma trial and our progress in the Phase 1b/2 trial in EBV-positive solid tumors. Darrel’s track record makes him an ideal fit for Viracta at this critical inflection point as we look to accelerate our efforts to bring Nana-val to regulatory approval and further develop our pipeline so we can bring much-needed treatment options to patients.”

 

“I am excited to be joining the Viracta team during such an important period in the Company’s development,” said Dr. Cohen. “The growing clinical data underscores the potential of Viracta’s innovative ‘Kick and Kill’ approach to effectively address the unmet treatment needs for patients with EBV-associated cancers, with early clinical trial results supporting Nana-val's favorable benefit/risk profile in heavily pre-treated patients. I look forward to applying my expertise and working closely with the entire team to reach our goal of rapidly advancing Nana-val to its next phase of development, and ultimately realizing the full potential of Nana-val in important indications of high unmet medical need.”

 

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.

 

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 Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational, open-label Phase 1b/2 trial for

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the treatment of recurrent or metastatic EBV+ nasopharyngeal carcinoma 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 trials and updates regarding the same. 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.

 

These risks and uncertainties may be amplified by a resurgence of the COVID-19 pandemic, or by the emergence of another public health emergency/pandemic. 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

 

Media Contact:

Kathy Vincent

Greig Communications

kathy@greigcommunications.com

 

SOURCE Viracta Therapeutics, Inc.

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