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): April 16, 2020
(Exact name of registrant as specified in its charter)
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200 Technology Square
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(Registrants telephone number, including area code): (617) 714-6500
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|Common stock, par value $0.0001 per share||MRNA||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 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company ☐
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Entry into a Material Definitive Agreement.
On April 16, 2020, Moderna, Inc. (the Company) entered into a contract (the BARDA Contract) with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response. Under the BARDA Contract, the Company will receive an award of up to $483 million to accelerate the development of the Companys mRNA vaccine candidate (currently mRNA-1273) against the novel coronavirus (SARS-CoV-2). BARDA will fund the advancement of the mRNA vaccine candidate to potential licensure, including clinical studies of the candidate and the manufacture of the candidate for use in these studies.
The BARDA Contract could result in payments to the Company of up to approximately $483 million, and consists of an approximately two-year base period-of-performance and a total contract period-of-performance (base period plus option exercises) of up to approximately five years and six months (if necessary). Under the base period-of-performance, the Company will conduct activities intended to obtain licensure of mRNA-1273 through a biologics license application submission for mRNA-1273.
The BARDA Contract contains terms and conditions that are customary for government contracts of this nature, including provisions giving the government the right to terminate the contract at any time for its convenience.
The foregoing is a brief description of the material terms of the BARDA Contract and does not purport to be a complete description of the rights and obligations of the parties thereunder. The foregoing description is qualified in its entirety by reference to the BARDA Contract, which will be filed as an exhibit to the Companys Quarterly Report on Form 10-Q for the period ending June 30, 2020.
Regulation FD Disclosure.
On April 16, 2020, the Company issued a press release announcing its entry into the BARDA Contract, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 to this Current Report on Form 8-K, and in Exhibit 99.1 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.
Financial Statements and Exhibits.
|99.1||Press Release issued by Moderna, Inc. on April 16, 2020|
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.
|Date: April 16, 2020||By:||/s/ Lori Henderson|
General Counsel and Secretary
Moderna Announces Award from U.S. Government Agency BARDA for up to $483 Million to
Accelerate Development of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
Award will fund development of mRNA-1273 to FDA licensure
Award will fund manufacturing process scale-up to enable large-scale production in 2020 for pandemic response
NIH-led Phase 1 study of mRNA-1273 has completed enrollment of 3 dose cohorts (25 µg, 100 µg and 250 µg); expanding to an additional 6 cohorts of older adults and elderly adults
Phase 2 study expected to begin in Q2 2020, following safety data from ongoing Phase 1 study
Moderna to hire up to 150 new team members to support efforts
Conference call to be held on Friday, April 17 at 8:00 a.m. ET
CAMBRIDGE, Mass., April 16, 2020 Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to accelerate development of the Companys mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).
Under the terms of the agreement, BARDA will fund the advancement of mRNA-1273 to FDA licensure. A Phase 1 study of mRNA-1273 is being conducted by the National Institutes of Health (NIH). The Phase 1 open-label study, which began on March 16, 2020 has completed enrollment of the original study: 45 healthy adult volunteers ages 18 to 55 years in three dose cohorts (25 µg, 100 µg and 250 µg). The NIH recently amended the Phase 1 protocol to include an additional six cohorts: three cohorts of older adults (ages 51-70) and three cohorts of elderly adults (age 71 and above). Enrollment for these cohorts is ongoing.
If supported by safety data from the Phase 1 study, the Company intends to begin a Phase 2 study of mRNA-1273 under its own Investigational New Drug (IND) application in the second quarter of 2020. Subject to data from these studies and discussions with regulators, a Phase 3 study could begin as soon as fall, 2020. BARDA funding will support these late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020 to enable potential pandemic response.
To support the scale-up, Moderna plans to hire up to 150 new team members in the U.S. this year. This includes a significant increase in its skilled manufacturing staff to expand manufacturing capacity from two shifts per day, 5 days per week to three shifts per day, 7 days per week, engineers to manage process scale-up, and clinical and regulatory staff to support clinical development.
We are thankful for BARDAs support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2, said Stéphane Bancel, Modernas Chief Executive Officer. Time is of the essence to provide a vaccine against this pandemic virus. By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic.
Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus, said BARDA Director Rick Bright, Ph.D. Delivering a safe and effective vaccine for a rapidly spreading virus requires accelerated action. BARDAs goal is to have vaccine available as quickly as possible and preparing now for advanced stage clinical trials and production scale-up while the Phase 1 is underway could shave months off development of COVID-19 vaccines.
Conference Call and Webcast Information
Moderna will host a live conference call and webcast at 8:00 a.m. ET on Friday, April 17, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 5115809. A webcast of the call will also be available under Events and Presentations in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Modernas website approximately two hours after the conference call.
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIH-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. A summary of the Companys work to date on SARS-CoV-2 can be found here.
About Modernas Prophylactic Vaccines Modality
Moderna scientists designed the Companys prophylactic vaccines modality to prevent infectious diseases. More than 1,400 participants have been enrolled in Modernas infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia. Clinical data demonstrate that Modernas proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across six Phase 1 studies, the Company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.
Moderna currently has nine development candidates in its prophylactic vaccines modality, including:
Vaccines against respiratory infections
Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
RSV vaccine for young children (mRNA-1345)
Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
Novel coronavirus (SARS-CoV-2) vaccine (mRNA-1273)
Influenza H7N9 (mRNA-1851)
Vaccines against infections transmitted from mother to baby
Cytomegalovirus (CMV) vaccine (mRNA-1647)
Zika vaccine (mRNA-1893 with BARDA)
Vaccines against highly prevalent viral infections
Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts for seven prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV and Zika). Modernas CMV vaccine is currently in a Phase 2 dose-confirmation study. Modernas investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the bodys cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Companys platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Sciences list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Companys development of a potential vaccine against the novel coronavirus, BARDA funding for the development and manufacture of mRNA-1273 and the sufficiency of such funding, the intention to file an IND related to mRNA-1273, the expected conduct and timing of Phase 2 and Phase 3 clinical trials of mRNA-1273, potential future supply of mRNA-1273, and future hiring plans. 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, 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 Modernas 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 there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-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 Modernas most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SECs website at www.sec.gov. Except as required by law, Moderna 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 are based on Modernas current expectations and speak only as of the date hereof.
Senior Manager, Corporate Communications
Head of Investor Relations