Current Report Filing (8-k)
June 03 2019 - 06:31AM
Edgar (US Regulatory)
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): June 1, 2019
MODERNA, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-38753
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81-3467528
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(State or other jurisdiction
of Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification Number)
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200 Technology Square
Cambridge, MA
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02139
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(Address of registrants principal executive office)
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(Zip code)
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(617)
714-6500
(Registrants telephone number, including area code)
N/A
(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:
☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 203.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17
CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading
symbol(s)
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Name of each exchange
on which registered
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Common stock, par value $0.0001 per share
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MRNA
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The NASDAQ Stock Market LLC
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of
1933 or Rule
12b-2
of the Securities Exchange Act of 1934.
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 7.01
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Regulation FD Disclosure
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On June 1, 2019, Moderna, Inc. (the Company) issued a press release announcing interim data from a Phase 1 study of mRNA-4157 personalized
cancer vaccine (PCV). The data were presented on Saturday, June 1, 2019 at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. A copy of the press release is furnished as Exhibit 99.1 to this Current
Report on Form
8-K
and a copy of slides presented at the ASCO Annual Meeting are furnished as Exhibit 99.2 to this Current Report on Form
8-K.
Additionally, at the ASCO Annual Meeting, the National Cancer Institute (NCI) presented early data from four patients in its Phase 1 study of PCV
mRNA-4650 as a monotherapy for patients with advanced metastatic cancers. Early data found that mRNA-4650 was safe at all dose levels studied to date (0.13 and 0.39 mg) with no reported dose-limiting toxicities and no related grade 3/4 adverse
events or serious adverse events. The NCI detected neoantigen-specific CD4 and CD8
T-cell
responses against neoantigens included in the vaccine in the three patients evaluated to date. Immunogenicity analysis
is ongoing for the fourth patient. The NCI program for mRNA-4650 uses the Companys mRNA technology but uses a different neoantigen selection process and study design than the Companys Phase 1 mRNA-4157 study.
The information in this Item 7.01 to this Current Report on
Form 8-K,
and in Exhibits 99.1 and 99.2 furnished
herewith, shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall such
information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits.
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.
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Date: June 3, 2019
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MODERNA, INC.
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By:
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/s/ Lori Henderson
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Lori Henderson
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General Counsel and Corporate Secretary
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