Moderna Announces Updates on Pandemic Influenza Program

Rhea-AI Summary

Moderna (NASDAQ:MRNA) has received ongoing support from the U.S. Department of Health and Human Services (HHS) to accelerate the development of mRNA-based pandemic influenza vaccines. The $590 million award, made through the Rapid Response Partnership Vehicle (RRPV) Consortium with BARDA funding, will support late-stage development, licensure of pre-pandemic vaccines, and expansion of clinical studies for up to five additional pandemic influenza subtypes.

The company initiated a Phase 1/2 study in 2023 to evaluate safety and immunogenicity of mRNA-1018, an investigational pandemic influenza vaccine targeting H5 and H7 avian influenza viruses, in adults aged 18 and older. Following positive preliminary data, Moderna plans to advance mRNA-1018 to Phase 3 trials and will present Phase 1/2 results at an upcoming scientific meeting.

Positive

• Secured $590 million government funding for pandemic influenza vaccine development
• Positive preliminary Phase 1/2 data enabling advancement to Phase 3 trials
• Expansion potential for up to five additional influenza subtypes

Negative

• None.

Insights

Biotech Research Analyst

The $590 million BARDA funding for Moderna's pandemic influenza program represents a substantial validation of their mRNA platform beyond COVID-19. The progression of mRNA-1018 to Phase 3 trials, following positive Phase 1/2 data, signals strong momentum in expanding their vaccine portfolio. This development carries strategic importance for three key reasons:

1. Platform Validation: Success with influenza vaccines would demonstrate the versatility of Moderna's mRNA technology, potentially opening doors for applications in other infectious diseases.

2. Revenue Diversification: The BARDA contract provides immediate non-dilutive funding and positions Moderna to compete in the $7 billion global influenza vaccine market.

3. Technical Advancement: The inclusion of H5 and H7 avian influenza strains showcases the platform's ability to rapidly address emerging pandemic threats.

The market is currently undervaluing this development, focusing primarily on COVID-19 revenue decline. However, this program could become a significant growth driver, especially considering the annual recurring nature of flu vaccination programs.

Financial Analyst

This BARDA funding announcement materially strengthens Moderna's financial position and development pipeline. The $590 million award represents approximately 4.5% of Moderna's current market cap, providing significant non-dilutive capital for R&D advancement. Key financial implications include:

1. Cash Position Enhancement: This funding bolsters Moderna's already robust balance sheet, extending their operational runway and reducing the need for dilutive financing.

2. R&D Cost Offset: Government funding for late-stage development significantly reduces the company's out-of-pocket expenses for what is typically the most expensive phase of vaccine development.

3. Market Opportunity: Success in pandemic influenza could translate to annual revenues of $1-2 billion, assuming modest market penetration and premium pricing for mRNA-based vaccines.

The stock's current valuation multiple appears to primarily reflect COVID-19 vaccine revenues, suggesting potential upside as the market begins to price in the value of their expanding pipeline.

CAMBRIDGE, MA / ACCESS Newswire / January 17, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced ongoing support from the U.S. Department of Health and Human Services (HHS) to accelerate the development of mRNA-based pandemic influenza vaccines. The award was made through the Rapid Response Partnership Vehicle (RRPV) Consortium with funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR).

The project will provide additional support for late-stage development and licensure of pre-pandemic mRNA-based vaccines. The agreement will also support the expansion of clinical studies for up to five additional subtypes of pandemic influenza.

In 2023, Moderna initiated a Phase 1/2 study to generate safety and immunogenicity data of an investigational pandemic influenza vaccine (mRNA-1018) in healthy adults aged 18 years and older. The study included vaccine candidates against H5 and H7 avian influenza viruses. Based on the positive preliminary data from the Phase 1/2 study, Moderna is preparing to advance mRNA-1018 into Phase 3.

The Company looks forward to sharing the Phase 1/2 results at an upcoming scientific meeting. This $590 million award has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the commitment of funding from BARDA to Moderna to support the development of mRNA-based pandemic influenza vaccines; and the advancement of Moderna's current candidates against H5 and H7 avian flu viruses. 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 Moderna'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, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's 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 Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:

Chris Ridley
Global Head of Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

What is the value of MRNA's new government funding for pandemic influenza vaccines?

Moderna received a $590 million award from HHS/BARDA through the Rapid Response Partnership Vehicle Consortium for pandemic influenza vaccine development.

What stage is Moderna's pandemic influenza vaccine mRNA-1018 currently in?

mRNA-1018 has completed Phase 1/2 trials with positive preliminary data and is preparing to advance to Phase 3 trials.

Which influenza strains does Moderna's mRNA-1018 vaccine target?

mRNA-1018 targets H5 and H7 avian influenza virus strains.

How many additional influenza subtypes will MRNA study under the new funding?

The agreement supports the expansion of clinical studies for up to five additional subtypes of pandemic influenza.

When did MRNA begin Phase 1/2 trials for its pandemic influenza vaccine?

Moderna initiated the Phase 1/2 study for mRNA-1018 in 2023.