Moderna Extends YTD Drop on Mixed Early Flu Shot Data

Moderna (NASDAQ:MRNA) shares closed lower on Tuesday after the vaccine maker said that its vaccine against seasonal flu did not achieve “early success” in the Phase 3 trial. Following yesterday’s selloff, Moderna shares are now down 13.6% year-to-date (YTD).

During its 4th Vaccine Day event, Moderna said it also expects to launch six major vaccines in the next several years, with its Covid-19 jab currently being the only marketed product.

Preliminary Financial Targets Established

Moderna is hoping its respiratory vaccine candidates will help the company offset the sharp decline in revenue in the post-pandemic era. Analysts expect Moderna’s Covid vaccine sales to be around $7 billion in 2023, implying a significant drop-off compared to the $18.4 billion the company generated in 2022.

The decrease in demand for Covid shots led to tighter investor scrutiny of Moderna’s experimental mRNA-based vaccines against flu and respiratory syncytial virus (RSV). The Cambridge, Massachusetts-based company is currently testing whether its experimental flu jab, known as mRNA-1010, is as efficient as the approved flu vaccine.

mRNA-1010, which is being developed in adults, is currently being tested in two Phase 3 trials. However, the biotech company said there was not enough available data to conclude whether the vaccine would succeed, and it remains unclear if it will accumulate sufficient information from the trial during the current flu season.

“Company's first influenza candidate, mRNA-1010, did not accrue sufficient cases at the interim efficacy analysis to declare early success in the Phase 3 Northern Hemisphere efficacy trial and the independent DSMB recommended continuation of efficacy follow-up,” Moderna said in the press release.

Stephen Hoge, President of Moderna, said he expected to start generating income from the flu vaccine next year, though the figure depends on the timing of the jab rollout.

New Cancer Vaccines to be Tested

In addition to flu shots, Moderna also intends to launch a range of vaccines against cancer, heart disease, and other life-threatening conditions by 2030, the company’s spokesperson said on Monday.

This confirms earlier comments made by Moderna’s chief medical officer Paul Burton, who said that he feels confident that those life-saving shots will be ready for launch by the end of the decade.

Burton also said that developments made in mRNA technology since the coronavirus outbreak have introduced a golden age for new vaccines.

“I think what we have learned in recent months is that if you ever thought that mRNA was just for infectious diseases, or just for Covid, the evidence now is that that’s absolutely not the case,” Burton said in an interview with the Guardian.

“It can be applied to all sorts of disease areas; we are in cancer, infectious disease, cardiovascular disease, autoimmune diseases, rare disease,” said Burton, adding that studies on vaccines against those diseases have displayed “tremendous promise.”

Thanks to its messenger RNA technology, Moderna saw growth during the coronavirus pandemic. This innovative technology teaches human cells to create a protein that grants immunity against a certain disease.

During Vaccine Day, Burton turned the spotlight on Moderna’s personalized cancer jab - an mRNA vaccine co-developed with pharmaceutical company Merck to target different types of tumors. According to Burton, this long-awaited shot will be very effective and could “save hundreds of thousands, if not millions of lives.”

He also highlighted mRNA’s ability to combat rare diseases that have no available treatments yet, adding those therapies could be ready about a decade from now.

One such disease is RSV - a deadly virus that causes infections of the respiratory tract. Moderna is one of a few drugmakers in the world in the race to roll out the first vaccine against RSV.

Focus on Cancer Vaccine Trials

In December, Moderna released positive data relating to mRNA-based experimental cancer vaccine trials. The shot, which represents a combination of Moderna’s personalized cancer vaccine and Merck’s successful immunotherapy Keytruda, reduced the risk of recurrence or death of melanoma by 44%, compared with Keytruda alone in a mid-stage trial.

The results from the trial displayed “clinically meaningful improvement,” the two companies said. The study marked the first randomized trial showing that combining mRNA technology with a drug that boosts immune response would offer higher efficiency against melanoma and other types of cancer.

The shot is being tested in an ongoing trial involving 157 patients with stage III/IV melanoma in patients who had their tumors surgically removed before receiving the combo treatment or Keytruda alone.

After a year of treatment, the combination showed additional benefits compared with Keytruda alone. Significant drug-related side effects were seen in 14.4% of patients who received the vaccine/drug combo, compared with 10% of those who only received Keytruda.

"It's a tremendous step forward in immunotherapy," said Eliav Barr, Merck's head of global clinical development and chief medical officer.

The spotlight now turns to April 16 when the 2023 American Association of Cancer Research (AACR) annual meeting takes place. Moderna and Merck are expected to share the latest trial data and results for their melanoma cancer vaccine.

Summary

Moderna shares are trading lower this week after the company said its first experimental flu shot didn’t accumulate enough data to determine efficacy in the Phase 3 study. Investors will now shift their focus toward the upcoming cancer vaccine data that could be expected early next week.

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Shane Neagle is the EIC of The Tokenist. Check out The Tokenist’s free newsletter, Five Minute Finance, for weekly analysis of the biggest trends in finance and technology.