Company's flu vaccine, mRNA-1010, met its primary endpoint in Phase 3 trial; separate Phase 1/2 data demonstrated higher HAI titers than Fluzone HD

Vaccine pipeline advancing rapidly with Company announcing the completion of RSV BLA filing (mRNA-1345), completion of adult enrollment in the Phase 3 trial of mRNA-1647, a first-in-class vaccine against CMV, and the Phase 3 trial of mRNA-1283, a next-generation COVID-19 vaccine

With its partner Merck, the Company plans to begin a second Phase 3 trial of mRNA-4157, its individualized neoantigen therapy (INT), in combination with Keytruda®, for non-small cell lung cancer later this year; updated efficacy follow-up from the ongoing Phase 2 study in adjuvant melanoma expected in Q4

With positive clinical data announced in mRNA-3705, a treatment for methylmalonic acidemia, the Company has three chronic rare disease medicines that have demonstrated potential for clinical benefit in patients

Over the next five years, the Company expects to launch up to 15 new products addressing high unmet needs, to bring up to 50 new candidates into clinical trials and to continue expanding the field of mRNA into new applications

CAMBRIDGE, MA / ACCESSWIRE / September 13, 2023 /Moderna, Inc. (NASDAQ:MRNA) today announced business and clinical updates across its franchises and introduced several new development programs at the Company's annual R&D Day.

"Our mRNA platform is working. With today's positive Phase 3 flu results, along with previous results in COVID and RSV, we are now three for three on advancing respiratory disease programs to positive Phase 3 data," said Stéphane Bancel, Chief Executive Officer of Moderna. "In the near term, we look forward to product launches in our oncology, latent, rare and infectious disease franchises.In the fourth quarter of this year, we also expect to provide data on our next-generation COVID and flu combination, mRNA-1083, and additional efficacy analysis on our Phase 2 INT study. With significant momentum across the business and our pipeline, we are excited by the near future and focused on execution."

Expanding the Field of mRNA MedicineModerna was founded and built to use nature's information molecule, mRNA, to treat and prevent disease. The premise has always been that an mRNA-based approach to making medicine could advance at the pace of information, leveraging common science, technology, and infrastructure to create medicines addressing high unmet needs at unprecedented speed and efficiency.

Through more than a decade of investment in science, the Company has created the field of mRNA medicine. The Company has advanced a diverse pipeline and demonstrated the potential for clinical benefit in cancer (mRNA-4157), in three different rare diseases (mRNA-3705, mRNA-3927, mRNA-3745), and multiple infectious disease vaccines (mRNA-1273, mRNA-1345, mRNA-1010). The Company has advanced six programs into late-stage development, including two approved or filed for approval, and three more that have completed Phase 3 enrollment. The Company expects to double the number of programs in Phase 3 by 2025 and launch up to 15 products in five years across cancer, rare disease, and infectious disease. Up to four of those launches could come by 2025.

Staying true to its mission, over the next five years the Company will continue to invest in science to expand the field of mRNA medicine into new frontiers and expects to advance up to 50 new candidate medicines into clinical trials across established and new modalities.

Updates and recent progress include:

RESPIRATORY FRANCHISEModerna's respiratory pipeline continues to exhibit consistent efficacy in older adults and immunocompromised individuals. The Company is also advancing its efforts to develop multiple generations of single-virus and combination respiratory vaccines that address significant public health needs.

The respiratory franchise, now a seasonal business with an annual recurring revenue stream, is targeting an approximately $30 billion annual market, comprised of an approximately $15 billion COVID-19 market, a $10 billion RSV market, and a $6 billion flu market, with the potential for growth with more effective vaccines. Respiratory products sales in 2027 are expected to be in the range of $8 billion to $15 billion, depending on vaccination rates, efficacy and Company market share, as previously communicated at Vaccines Day.

COVID-19 Vaccine UpdateFollowing the June FDA VRBPAC meeting, the Company demonstrated potent neutralization and cross-reactivity with its monovalent XBB.1.5 vaccine, mRNA-1273.815, with similar neutralization for XBB.1.5, XBB.1.16, and XBB.2.3.2 sub-variants. Clinical trial data from research assays also confirmed mRNA-1273.815 showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and FL.1.5.1. With these data, Moderna has confirmed an antibody response against current strains of concern, suggesting that the updated vaccine is well-matched for the upcoming vaccination season.

On September 11, 2023, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Spikevax® for ages 12 years and above. Emergency Use Authorization (EUA) for the Moderna COVID-19 Vaccine was also received for individuals 6 months through 11 years of age. Moderna's updated COVID-19 vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. Clinical trial data confirm mRNA-1273.815 showed a strong immune response in humans against BA.2.86, EG.5 and FL.1.5.1 variants. With the U.S.FDA's decision, Moderna has begun shipping doses to vaccination sites across the U.S., with updated vaccines expected to be available in the coming days.

In addition, the Company's next-generation, refrigerator-stable COVID-19 vaccine, mRNA-1283, demonstrated encouraging results in multiple clinical studies and has now completed enrollment of its Phase 3 trial.

Seasonal Influenza VaccinemRNA-1010 demonstrated an acceptable safety and tolerability profile across all clinical trials to date, including three Phase 3 trials (P301, P302, P303), and independent data and safety monitoring boards (DSMBs) have raised no safety concerns.

Enrollment is complete in the Company's Phase 3 safety and immunogenicity trial for the updated formulation of mRNA-1010 (P303). In an interim analysis of the P303 study,mRNA-1010 met all co-primary endpoints across all four A and B strains (A/H1N1, A/H3N2, influenza B/Yamagata, B/Victoria). Higher HAI geometric mean titers and seroconversion rates were observed for all four strains compared to a licensed comparator (Fluarix). Local and systemic solicited adverse reactions were similar to those reported in previous mRNA-1010 studies.

Improved immunogenicity was observed across age groups, and importantly, was seen in older adults. mRNA-1010 also elicited higher HAI titers against A/H1N1, A/H3N2, B/Victoria, and comparable titers to B/Yamagata compared to Fluzone HD in a separate Phase 1/2 head-to-head study. Consultations with regulators on a potential licensing package are currently ongoing based on these data.

As the previous P302 efficacy study has not accrued its target case numbers by the end of the most recent season, the Company would need to enroll a second season to accrue enough cases. In light of P303 meeting all its primary endpoints, the Company has decided not to enroll a second season in the P302 study.

The Company continues to advance a portfolio of influenza vaccine candidates that include additional HA antigens for broader coverage of circulating influenza A strains (mRNA-1011 and mRNA-1012) and candidates that incorporate both HA and neuraminidase (NA) antigens to target multiple proteins involved in the influenza virus lifecycle to reduce the potential of viral antigenic escape (mRNA-1020 and mRNA-1030).

Respiratory Syncytial Virus (RSV) VaccineModerna has submitted marketing authorization applications globally for mRNA-1345, a vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older. The Company filed for a Biologics License Application (BLA) with the FDA and used a Priority Review Voucher (PRV). The Company expects an April 2024 PDUFA date. Regulatory applications were also submitted in Europe (EMA), Switzerland (Swissmedic), Australia (TGA), Canada (Health Canada), and United Kingdom (MHRA).

The regulatory applications are based on positive data from the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older. The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p