SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 7, 2021
REPLIMUNE GROUP, INC.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction
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 5.02||Departure of Directors or Principal Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.|
On May 7, 2021, Tanya Lewis notified Replimune Group, Inc. (the “Company”) of her resignation from the Company’s Board of Directors (the “Board”), effective immediately. Ms. Lewis’s resignation from the Board is not the result of any disagreement with the Company or the Board on any matter relating to the Company’s operations, policies or practices.
|Item 8.01||Other Events.|
On May 10, 2021, the Company issued a news release announcing that Ms. Lewis joined the Company as its Chief Development Operations Officer, effective May 10, 2021. A copy of the news release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein. The Company undertakes no obligation to update, supplement or amend the materials attached hereto.
|Item 9.01||Financial Statements and Exhibits.|
|99.1||News Release dated May 10, 2021|
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: May 10, 2021||By:||/s/ Jean Franchi|
|Chief Financial Officer|
Replimune Appoints Tanya Lewis as Chief Development Operations Officer
Woburn, MA, May 10, 2021– Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic® platform, today announced the strengthening of its executive team with the appointment of Tanya Lewis to a newly created position of Chief Development Operations Officer effective May 10, 2021. Ms. Lewis previously served on Replimune’s board of directors and resigned on May 7th in order to join the executive team.
Ms. Lewis joins from Karyopharm Therapeutics, a publicly traded biopharmaceutical company, where she served as Executive Vice President, Chief Regulatory Strategy and Strategic Operations Officer and was responsible for project management and portfolio review including navigating the approval of XPOVIO®. Prior to joining Karyopharm, Ms. Lewis held leadership positions at several companies, including Tesaro and Millennium, where she developed approval strategies and led interactions with U.S. and European regulators. Tanya’s past accomplishments include the successful negotiations for registration trial designs, approval, and/or commercialization of VELCADE®, VARUBI®, INTEGRILIN®, and ZEJULA®.
As Chief Development Operations Officer, Ms. Lewis will work with Replimune’s senior leadership team to execute an integrated clinical, regulatory and CMC strategy to facilitate multiple potential BLA filings and product registrations.
“Our vision extends well beyond our initial lead indications in skin cancer, with the broader aim of becoming a cornerstone of immuno-oncology treatments across a wide spectrum of tumor types. This will necessitate conducting multiple later stage clinical trials in parallel, intended to result in multiple regulatory filings for product approvals across geographies. The creation of this role is intended to provide the operational organizational oversight, direction and bandwidth to fulfill this ambition. We have had the great pleasure of working with Tanya and benefiting from her insights in her role as a non-executive Director on our Board and are excited that Tanya will now join our executive leadership team where her deep experience in shepherding multiple high profile drugs through to regulatory approval in the US and EU will be invaluable,” said Philip Astley-Sparke, Chief Executive Officer of Replimune.
Tanya Lewis commented: “The potential of Replimune’s pipeline of oncolytic immuno-gene therapies has become ever more apparent during my time serving on the Board of Directors. I am honored to be able to assist such an experienced and dedicated team in creating an expansive product development program focused on bringing these novel treatments to a broad range of patients with cancer.”
Tanya holds a Bachelor of Science degree in Biology from Northeastern University and a Master of Science degree in Regulatory Affairs and Health Policy from Massachusetts College of Pharmacy and Health Sciences.
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 to develop the next generation of oncolytic immune-gene therapies for the treatment of cancer. Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released. Replimune’s Immulytic® platform is designed to maximize systemic immune activation, in particular to tumor neoantigens, through robust viral-mediated immunogenic tumor cell killing and the delivery of optimal combinations of immune-activating proteins to the tumor and draining lymph nodes. The approach is expected to be highly synergistic with immune checkpoint blockade and other approaches to cancer treatment across a broad range of cancers. Replimune intends to progress these therapies rapidly through clinical development in combination with other immuno-oncology products with complementary mechanisms of action as well as in standalone indications. 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 the advancement of our clinical trials, our plans to initiate new clinical trials, our goals to develop and commercialize our product candidates, the breadth and applicability of our technology, product candidates and potential product candidates, 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, 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.
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