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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):  January 4, 2023

 

 

 

REPLIMUNE GROUP, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38596   82-2082553
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification Number)

 

500 Unicorn Park

Woburn, MA 01801

(Address of principal executive offices, including Zip Code)

 

Registrant’s telephone number, including area code: (781) 222-9600

 

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 $0.001 per share   REPL   The Nasdaq Stock Market LLC
(Nasdaq Global Select Market)

 

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 x

 

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. x

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On January 4, 2023, Replimune Group, Inc. (“Replimune”) issued a press release announcing the appointment of Chris Sarchi as its Chief Commercial Officer and, in connection therewith, the appointment of Sushil Patel, Replimune’s previous Chief Commercial Officer, to a newly formed position of Chief Strategy Officer, effective immediately. A copy of the press release is furnished herewith as Exhibit 99.1.

 

The information contained in this Item 7.01 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any filing of Replimune, whether made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference to such filing. The information in this Item 7.01 and the accompanying Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended.

 

Item 9.01 Financial Statement and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
     
99.1   News Release, dated January 4, 2023, announcing the appointment of Chris Sarchi and Sushil Patel as Replimune’s Chief Commercial Officer and Chief Strategy Officer, respectfully.
104   Cover page interactive data file (formatted as Inline XBRL)

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  REPLIMUNE GROUP, INC.
     
Date: January 4, 2023 By: /s/ Jean Franchi
    Jean Franchi
    Chief Financial Officer

 

 

Exhibit 99.1

 

Replimune Appoints Former Sanofi U.S. Commercial Oncology Head, Chris Sarchi, as Chief Commercial Officer and Sushil Patel as Chief Strategy Officer

 

Woburn, MA, January 4, 2023 – Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies (TDOIs), announced today the appointment of Christopher Sarchi as Replimune’s Chief Commercial Officer and the appointment of Sushil Patel, Ph.D., previously Replimune’s Chief Commercial Officer, to a newly formed position of Chief Strategy Officer, effective immediately.

 

“These leadership appointments provide broad strategic and operational commercial acumen as we ramp up our commercial planning ahead of the potential 2024 launch of RP1,” said Philip Astley-Sparke, Chief Executive Officer of Replimune. “Chris led Libtayo’s launch in CSCC at Sanofi and was also involved with the launch of Erivedge in BCC when at Genentech. As such he has direct and relevant experience in the field of our lead indication which will be invaluable as we seek to establish a major skin cancer franchise with RP1. Sush will partner with Chris on our go to market strategy in the U.S. with RP1 and in defining an ex-U.S. commercialization strategy. In addition, Sush will lead strategic planning and communications across our entire platform as we seek to address indications beyond skin cancers with RP2 and RP3 including those requiring deep injection techniques.”

 

Chris brings more than 28 years of oncology experience, including 9 new product launches/expansions covering multiple tumor types and settings while building strong relationships with oncology physicians, nurses and pharmacy leaders throughout the oncology market. Chris joins Replimune having recently served as Head of Commercial U.S. Oncology at Sanofi where he was responsible for several launches, including the launch of Libtayo® as a new standard of care treatment for CSCC. Prior to heading the U.S. commercial oncology team at Sanofi, Chris was Vice President and Business Unit Head, Oncology and Biosimilars, at Boehringer Ingelheim, Inc. after serving as a commercial leader within the oral oncolytic franchise at Roche/Genentech where he launched Erivedge® in basal cell carcinoma and coordinated internal co-promotion of Tarceva® and Avastin®. Chris began his career with GSK where he held several sales and marketing leadership roles of increasing responsibility. Chris received a Bachelor of Science and Business Administration from the University of Maine.

 

Sushil most recently served as Replimune’s Chief Commercial Officer. Prior to joining Replimune in 2021, Sushil served as Franchise Head in Global Product Strategy for Genentech, a member of the Roche Group, where he was responsible for directing the company’s lung and skin cancer franchise with responsibility for multiple blockbuster drugs, generating in excess of $3.5 billion in annual global sales. Prior to his career in biotechnology, he worked as a strategic management consultant and at IMS Health in their Pharma Strategy Group. Sushil received a Doctor of Philosophy in Molecular Biology and a Master of Sciences in Biotechnology, both from the Imperial College of Science Technology and Medicine, University of London.

 

 

About Replimune

 

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel tumor-directed oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone with payloads added to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform has a unique dual local and systemic mechanism of action (MOA) consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment (TME) to ignite a strong and durable systemic response. This MOA is expected to be synergistic with most established and experimental cancer treatment modalities, and, with an attractive safety profile the RPx platform has the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues, the ongoing military conflict between Russia and Ukraine and the impact on the global economy and related governmental imposed sanctions, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.

 

Investor Inquiries

Chris Brinzey

ICR Westwicke

339.970.2843

chris.brinzey@westwicke.com

 

Media Inquiries

Lissette Steele

Verge Scientific Communications

202.930.4762 x 409

lsteele@vergescientific.com

 

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