Item 7.01. Regulation FD.
On March 30, 2020, the U.S. Department of Health and Human Services (HHS) issued a press release (https://www.hhs.gov/about/news/2020/03/30/hhs-accelerates-clinical-trials-prepares-manufacturing-covid-19-vaccines.html) announcing that the Biomedical Advanced Research and Development Authority (BARDA) will collaborate with Moderna, Inc. (the “Company”) to prepare now for Phase 2 and Phase 3 clinical trials of the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus(SARS-CoV-2).
The HHS press release further noted that:
| | • | | The Phase 2 and Phase 3 clinical trials require enrolling hundreds, and potentially thousands of people to determine the investigational vaccine’s safety and effectiveness; |
| | • | | BARDA support includes expertise and funding to expand manufacturing in order to produce thousands of doses of the investigational vaccine for these studies; |
| | • | | Collaborating on clinical trial preparation now means the later clinical trial phases can begin immediately upon successful completion of the Phase 1 clinical trial currently underway; and |
| | • | | Working in parallel instead of taking the traditional sequential approach to vaccine development potentially shaves months off the timeline for vaccine development. |
Information in this Item 7.01 to this Current Report onForm 8-K 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.
Cautionary Note Regarding Forward-Looking Statements
The Company cautions you that statements included in this Current Report on Form8-K that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements describing the content of the HHS press release relating to a collaboration between the Company and BARDA, potential clinical trial enrollment and timing of future clinical trials. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” “likely,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond the Company’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that the Company is providing a link to the HHS press release for reference purposes only and the HHS is not a spokesperson for the Company; the fact that the HHS press release should be considered in conjunction with the factors outlined in this Current Report on Form 8-K and in the Company’s filings with the U.S. Securities and Exchange Commission (SEC); the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by the Company is still being developed and implemented; that the BARDA collaboration has not yet been finalized; further potential delays in clinical trials due to the global SARS-CoV-2(COVID-19) pandemic, including with respect to site initiation, participant recruitment and enrollment, participant dosing, distribution of clinical trial materials, study monitoring and data analysis; other potential adverse impacts due to the globalCOVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form10-K filed with the SEC and in subsequent filings made by the Company with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements speak only as of the date hereof.
