Intismeran Autogene

Moderna\'s R&D costs fell 19% to $856 million in the first quarter.\n Moderna is deprioritizing its flu/COVID combination vaccine in younger adults amid a push to cut around $1.5 billion from its operating expenses. The biotech disclosed the changes alongside news of a delay to the expected approval of the vaccine in older adults. Massachusetts-based Moderna filed for FDA approval of its mRNA-1083 combination shot last year. As of February, the mRNA specialist was aiming to win approval in adults aged 50 years and older this year and expand the label to cover younger adults in 2027. Moderna axed both targets in its first-quarter results Thursday.The biotech has deprioritized the development of mRNA-1083 in people aged 18 to 49 years. Moderna is still working to get the vaccine to older adults, but the process is taking longer than hoped. Having filed for approval using immunogenicity data, Moderna has learned the FDA wants to see phase 3 efficacy data before signing off on the vaccine. The request pushes the targeted approval date back into 2026.Uptake of standalone COVID-19 and flu vaccines is lowest in the demographic deprioritized by Moderna. As of last month, the Centers for Disease Control and Prevention (CDC) estimated 36.2% of people aged 18 to 49 years in the U.S. had received a flu vaccine for the 2024 to 2025 season. Uptake rose to 48.9% in people aged 50 to 64 years and 72.0% in seniors.  The COVID-19 vaccination data follow the same pattern. Around 14% of people aged 18 to 49 years have received a 2024 to 2025 COVID-19 vaccine, according to the CDC, compared to 44.2% of people aged 65 years and older. Stephen Hoge, M.D., Moderna’s president, talked up the prospects of the combination shot at an event run by TD Cowen in March. Hoge said Moderna’s market research found around two-thirds of people are likely to prefer the combination product over monotherapy vaccines. “We do believe that the combination product is the majority, for convenience, and ultimately on healthcare systems is much less of a burden. You can do twice as many injections and take half as much time, half the infrastructure, much more efficient from a storage perspective, all of the above,” Hoge said. “So, for all those reasons, we really do believe the combo is the best.”Moderna used its first-quarter results to outline its ambition to reduce its operating expenses by up to $1.7 billion by 2027. R&D costs fell 19% to $856 million in the first quarter. Moderna attributed the drop to “lower clinical development costs across respiratory programs due to timing of trial activities and program wind-downs.”The decline in spending on respiratory programs was partly offset by increased investment in the individualized neoantigen therapy mRNA-4157 and norovirus programs. Moderna said the FDA has lifted the hold it put on its norovirus program in response to a case of Guillain-Barré syndrome. The timing of the phase 3 readout will depend on case accruals. 

iStock, Olena Koliesnik Jefferies analysts said Moderna’s first quarter was “in line,” with a miss on revenue offset by a beat on earnings per share. Moderna’s sales continued to tumble in the first quarter, falling to $84 million compared to analyst expectations of $100 million. But the mRNA biotech managed to beat on earnings per share (EPS) thanks to aggressive cost cutting measures that lowered operating expenses. In that vein, the company on Thursday announced plans to cut another $1.5 billion by 2027, adding to billions in cuts that are already planned. CEO Stéphane Bancel also reiterated the company’s ambitious plan to earn 10 product approvals by the end of 2027. And despite the quarter’s earnings miss, the company reaffirmed its 2025 financial guidance of revenue ranging between $1.5 billion and $2.5 billion. Jefferies analysts said Moderna’s first quarter was “in line,” with the EPS beat helping to make up for the lower-than-expected sales. Sales came in at $86 million, compared to Jefferies’ estimate of $115 million, but the company reported a loss of only $2.52 earnings per share instead of the $3.12 that Jefferies had been expecting. On the company’s Q1 earnings call early Thursday, Moderna executives repeatedly downplayed the potential effects of political turmoil on its pipeline. CFO Jamey Mock said that President Trump’s proposed pharmaceutical tariffs “have not had a significant direct impact on Moderna,” as much of its vaccine manufacturing already takes place in Massachusetts. As for the company’s interactions with the FDA, Stephen Hoge, the company’s president, said that agency assessments have been “constructive and positive” and there have been no signs that PDUFA dates might not be met. “It really has been business as usual,” Hoge said when asked about potential disruptions to review of mRNA-1283, Moderna’s next-generation COVID-19 vaccine that is awaiting an FDA decision at the end of this month. When asked about HHS Secretary Robert F. Kennedy, Jr.’s suggestion that single-antigen vaccines for respiratory illnesses like COVID-19 “have never worked,” Hoge again demurred. “We will continue to provide data because we believe that clinical data supports the benefits of our products,” Hoge said, pointing out that some of the company’s vaccines are single-antigen while others are multi-antigen. “Sometimes multi-antigen makes sense, sometimes single-antigen makes sense; we do both,” he added. “Again it has been business as usual through the first half of this year.” R&D Cuts, Priority Shifts and Clinical Holds This quarter’s numbers come as Moderna’s COVID-19 franchise undergoes a significant decline amid global vaccine trends. Moderna’s COVID-19 vaccine booked $29 million in the U.S. for the first quarter, with international sales adding another $55 million. Recently approved respiratory syncytial virus vaccine mRESVIA had sales of $2 million for the first quarter. The company cut R&D spending during the quarter by 19% to $856 million due to the timing of trials and programs that are being wound down. Moderna did funnel money into individualized neoantigen therapy mRNA-4157, which is now to be known as intismeran autogene. The vaccine is being tested in Phase III for head and neck cancer and melanoma. Meanwhile, the company is deprioritizing its flu-COVID combo mRNA-1083 for adults aged 18 through 49. The vaccine was submitted to the FDA for older adults in 2024, but the company has received feedback from the agency that Phase III efficacy data will be required. Moderna now expects the review timeline to be delayed, with a potential approval now pushed to 2026. Elsewhere, Moderna announced that the FDA has lifted a clinical hold on its norovirus program. A Phase III trial for mRNA-1403 was placed on a clinical hold earlier this year after a single report of Guillain-Barré syndrome, a rare neurological disorder that can be triggered by vaccination.