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): March 3, 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

 

Name of each exchange

on which registered

Common Stock, $0.0001 par value   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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Appointment of Directors

On March 3, 2021, the Board of Directors (the “Board”) of Viracta Therapeutics, Inc. (the “Company”) increased the size of the Board to nine (9) and appointed Barry J. Simon, M.D. and Stephen Rubino, Ph.D., MBA to the Board to fill the vacancies resulting from such increase, in each case effective March 3, 2021. Dr. Simon will serve as a Class II director and Dr. Rubino will serve as a Class III director. In addition, as set forth below, Dr. Simon was appointed as the Chairperson of the Compensation Committee and a member of the Audit Committee and Dr. Rubino was appointed as a member of the Audit Committee and the newly formed Science and Technology Committee.

Dr. Simon, 56, has served the President and Chief Administrative Officer of NantKwest, Inc. since January 2017 and served as President and Chief Operating Officer from March 2015 to December 2016. From 2007 to March 2015, Dr. Simon was NantKwest’s President and Chief Executive Officer. Dr. Simon has also served on the Board of Directors of NantKwest since 2007. He also serves on the board of directors of Cue BioPharma, a biopharmaceutical company and Brink Biologics Inc., a bioanalytics, reagents and testing services company, and previously served on the board of directors of Viracta Subsidiary, Inc. (previously named Viracta Therapeutics, Inc.) from July 2017 to November 2020. Previously, Dr. Simon held Vice President, senior level and advisory positions at F. Hoffmann-La Roche, a global healthcare company, Roche Labs, a pharmaceuticals company, Connetics Corporation, a specialty pharmaceutical company, Immunomedics, a biopharmaceutical company, Immusol, a biopharmaceutical company, HealthPro BioVentures, LLC, a healthcare and life sciences investment bank and NorthSound Capital, LLC, a U.S.-based hedge fund. Dr. Simon attended corporate training programs by the London School of Business and the Amos Tuck School of Business at Dartmouth College. Dr. Simon trained clinically in Infectious Diseases at Albert Einstein College of Medicine, Anesthesiology at The Mount Sinai Medical Center and Internal Medicine at New York University and received his M.D. from the SUNY Downstate Health Sciences Center in New York. The Board believes that Dr. Simon is qualified to serve as a member of the Board because of his extensive medical and scientific knowledge and experience, as well as his senior management experience in the biopharmaceutical industry.

Dr. Rubino, 62, has served as the Chief Business Officer of Celyad Oncology, a biotechnology company, since February 2020. Previously, Dr. Rubino served as Chief Business and Strategy Officer at Omega Therapeutics from May 2018 to May 2019, as an Entrepreneur in Residence at Fortress Biotech from March 2017 to May 2018, and in various positions at Novartis, a biotechnology company, from 2001 until 2017, including most recently as Global Head of Business Development & Licensing and New Product Marketing, Cell & Gene Therapy Unit, from November 2014 to March 2017. Dr. Rubino also serves on the board of directors of Sermonix Pharmaceuticals. Dr. Rubino received a Ph.D. in virology from Cornell University and an M.B.A. from Baruch College. The Board believes Dr. Rubino is qualified to serve on the Board because of his extensive management and commercial experience in the fields of biotechnology and oncology.

Each of Dr. Simon and Dr. Rubino will be compensated in accordance with the Company’s amended and restated outside director compensation policy, which has been filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 8, 2017. In addition, each of Dr. Simon and Dr. Rubino will enter into the Company’s standard form of indemnification agreement, a copy of which has been filed as Exhibit 10.5 to the Company’s Registration Statement on Form S-1 (File No. 333-121646) filed with the SEC on December 23, 2004.

There is no arrangement or understanding between either Dr. Simon or Dr. Rubino and any other persons pursuant to which either Dr. Simon or Dr. Rubino was elected as a director. In addition, neither Dr. Simon nor Dr. Rubino is a party to any transaction, or series of transactions, required to be disclosed pursuant to Item 404(a) of Regulation S-K. There are no family relationships between either of Dr. Simon or Dr. Rubino and any of the Company’s directors or executive officers. The Board has determined that Dr. Simon and Dr. Rubino meet the applicable independence requirements of The Nasdaq Stock Market LLC.

Promotion of Chief Operating Officer

Also on March 3, 2021, the Board approved the promotion of Daniel Chevallard, the Company’s Chief Financial Officer, Treasurer and Secretary to the additional role of Chief Operating Officer. There were no changes to Mr. Chevallard’s compensation arrangements in connection with the promotion.

Board Committees

In connection with the appointments of Dr. Simon and Dr. Rubino to the Board, the Board approved the reconfiguration of the Board committees as follows, in each case effective as of March 3, 2021: (i) Thomas E. Darcy, Dr. Rubino and Dr. Simon were appointed to the Audit Committee of the Board, and Mr. Darcy was appointed as the Chairperson of the Audit Committee, (ii) Dr. Simon, Mr. Darcy and Michael Huang, M.S., M.B.A. were appointed to the Compensation Committee of the Board, and Dr. Simon was appointed as the Chairperson of the Compensation Committee, and (iii) Roger J. Pomerantz, M.D., Nicole Onetto, M.D. and Gur Roshwalb, M.D., were appointed to the Nominating and Corporate Governance Committee of the Board, and Dr. Pomerantz was appointed as the Chairperson of the Nominating and Corporate Governance Committee.

In addition, also on March 3, 2021, the Board approved the formation of a new Science and Technology Committee to assist the Board in its oversight of the Company’s science and technology development and strategy. Dr. Onetto, Sam Murphy, Ph.D., and Dr. Rubino were appointed to the Science and Technology Committee, and Dr. Onetto was appointed as the Chairperson of the Science and Technology Committee.

Item 7.01. Regulation FD Disclosure.

On March 4, 2021, the Company issued a press release announcing the appointments of Dr. Simon and Dr. Rubino to the Board, Mr. Chevallard’s promotion to Chief Operating Officer and certain other organizational updates. A copy of the 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
Number 		  

Description

99.1    Press Release, dated March 4, 2021

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.

Dated: March 4, 2021

 

/s/ Daniel Chevallard

Daniel Chevallard
Chief Operating Officer and Chief Financial Officer

Exhibit 99.1

 

LOGO

Viracta Therapeutics Strengthens Company Leadership with New Appointments to the Board of

Directors and Management Team

Stephen Rubino, Ph.D., MBA and Barry J. Simon, M.D. appointed to the Board of Directors

Cheryl A. Madsen, RAC appointed as Senior Vice President, Regulatory Affairs

PR Newswire, San Diego, March 4, 2021 – Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced that it has strengthened its leadership team with the appointments of Drs. Stephen Rubino and Barry J. Simon to the Board of Directors, the addition of Cheryl A. Madsen, RAC as Senior Vice President, Regulatory Affairs, and the promotion of several members of the management team.

“The wealth of biotech leadership and executive experience Drs. Rubino and Simon bring to the Viracta Board will be invaluable as we continue to execute on our corporate strategy,” said Roger Pomerantz, M.D., F.A.C.P., Chairman of the Board of Directors of Viracta. “With the help of their counsel and strategic guidance, we aim to build on the momentum generated by our recent entrance into the public market and concurrent financing.”

“We are very pleased to be complementing these Board additions by bringing on Cheryl Madsen to lead our regulatory efforts,” said Ivor Royston, M.D., President and Chief Executive Officer of Viracta. “Cheryl has a proven record of success facilitating the regulatory processes involved in bringing oncology therapeutics to market, which will be crucial as we advance our novel all-oral combination therapy into a global registrational trial in relapsed/refractory Epstein-Barr virus (EBV)-positive lymphoma and further expand into EBV-positive solid tumors.”

In addition to the appointments of Ms. Madsen and Drs. Rubino and Simon, Viracta also announced the following management promotions, which are significant in the operations of Viracta as a publicly traded company:

 

  •

Dan Chevallard, formerly Chief Financial Officer, has been promoted to Chief Operating Officer and Chief Financial Officer

 

  •

Shelly Vandertie, formerly Senior Director, Finance & Controller, has been promoted to Vice President, Finance

 

  •

Michael Mueller, formerly Senior Director, Corporate Development & Legal Affairs, has been promoted to Vice President, Legal Affairs and General Counsel

Appointee Bios

Stephen Rubino, Ph.D., MBA has over 30 years of commercial and strategic development experience in the pharmaceutical and biotechnology industries. He is currently the Chief Business Officer at Celyad Oncology SA and sits on the Board of Sermonix Pharmaceuticals. Previously, he was the Chief Business & Strategy Officer at Omega Therapeutics and Global Head of Business Development and Licensing and New Product Marketing for the Cell and Gene Therapies business unit at Novartis Pharmaceuticals. At Novartis, Dr. Rubino led growth opportunities including evaluation, licensure, strategy and commercial development of products across a wide range of therapeutic areas. He received his Ph.D. in virology from Cornell University and an MBA from Baruch College.

 

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Barry J. Simon, M.D., is a healthcare executive with more than 30 years of experience spanning the public and private sectors. He previously served on Viracta’s board from July 2017 to November 2020 and is currently the President and Chief Administrative Officer (CAO) of Nantkwest, Inc. Prior to serving as Nantkwest’s President and CAO, he was the company’s President and Chief Executive Officer. Dr. Simon also serves on the boards of several additional life science companies including Nantkwest, Cue BioPharma and Brink Biologics Inc. He has broad experience in public and private companies, having led private and public equity offerings, product and portfolio divestitures and acquisitions, strategic licensing and joint ventures, as well as commercial product launches, IND and BLA regulatory filings, human-enabling programs, and manufacturing, quality control and life cycle management projects. Previously, he held Vice President, senior level and advisory positions at F. Hoffmann-La Roche, Roche Labs, Connetics Corporation, Immunomedics, Immusol, HealthPro BioVentures, LLC, and NorthSound Capital, LLC.

In his prior roles, Dr. Simon worked across several therapeutic areas including oncology, virology, ophthalmology and dermatology on product launches including Xeloda®, Pegasys®, Fortovase®, Tamiflu®, Camptobell®, Boniva®, Fuzeon®, Valcyt®, and Accutane®. Dr. Simon attended corporate training programs by the London School of Business and the Amos Tuck School of Business at Dartmouth College. He received his M.D. from the SUNY Downstate Health Sciences Center in New York and trained clinically in infectious diseases, anesthesiology, and internal medicine at Albert Einstein College of Medicine, The Mount Sinai Medical Center and New York University, respectively.

Cheryl A. Madsen, RAC brings over 25 years of regulatory affairs experience in the development of both biologics and small molecules ranging from pre-IND through commercial stage companies. Ms. Madsen joined Viracta Therapeutics from Calithera Biosciences where she served as Vice President of Regulatory Affairs. Previously, Ms. Madsen was the Vice President of Regulatory Affairs at Peloton Therapeutics where she facilitated the successful acquisition of their HIF2-a inhibitor (belzutifan) by Merck. Prior to that, she was a Senior Director at Medivation (acquired by Pfizer), where she played an instrumental role in the initial global regulatory filings, approval and launch of XTANDI® (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer. In addition to her regulatory responsibilities, she served as Project Team Leader for XTANDI from 2015-2016. She started her career at Genentech, where during her 13-year tenure she was responsible for the original filing and approval of AVASTIN® (bevacizumab) for first-line metastatic colorectal cancer. She also played a critical role in the parallel filing and approval of the HERCEPTIN® (trastuzumab) BLA for metastatic breast cancer and the premarket approval of HercepTest™, an in vitro diagnostic for HER2 expression and patient selection. Ms. Madsen received her bachelors degree in Psychology from U.C. Santa Cruz and completed additional post-graduate work in Molecular Biology and Biochemistry at U.C. Berkeley. She also holds U.S. and Global Regulatory Affairs Certifications from the Regulatory Affairs Professional Society.

 

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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 a Phase 2 clinical trial for EBV-positive lymphoma. Viracta is pursuing application of this 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, statements regarding: the significance of the Board of Director and management appointments and the expected contribution of the appointees; Viracta’s clinical development plans; 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 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:    Company 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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