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Moderna

PublicFounded 2010🇺🇸Cambridge, MassachusettsCEO Stéphane Bancel

Moderna is a public mRNA company whose commercial franchise includes Spikevax, mNEXSPIKE, mRESVIA, EU-approved mCOMBRIAX, and mFlusiva, with intismeran autogene plus KEYTRUDA as its highest-value pipeline bet after the August 19, 2026 Phase 3 melanoma win.

Latest update Oct 19, 2026

01

Overview

Juan Andres is Chief Operating Officer. A Form 3 filed October 5, 2026 lists that title with a period of report of October 5, and both the company and investor leadership pages now list him as COO. Jerh Collins is no longer on those executive lists. Merck and Moderna have not announced a US BLA or EU MAA. Phase 3 RFS and DMFS hazard ratios remain unpublished ahead of ESMO late-breaking abstract LBA1 on October 24, 2026. FY2025 revenue was $1.9 billion with a $2.8 billion net loss; Q2 2026 revenue was $145 million. A $3.0 billion zero-coupon convertible closed September 1. Cash-flow breakeven is still targeted for 2028.

modernatx.comUpdated Oct 19, 2026

Analysis · 5 min read · Sep 1, 2026The long view on Moderna: strategy, technology and what to watch

02

What's next7

  1. 2026

    First rare-disease registrational data

    Read out registrational data for the propionic acidemia program (mRNA-3927) - Moderna's first rare-disease readout, now partnered with Recordati (deal signed January 2026, closed March 16, 2026: $50M upfront plus up to $110M in milestones and royalties, with Recordati leading global commercialization). Part 2 of the Paramount study has completed enrollment, with a 12-month treatment evaluation and a data readout still expected in 2026. Moderna is also advancing methylmalonic acidemia therapy mRNA-3705, which was selected for the FDA's START pilot program; the company and FDA have agreed on a pivotal study design, with the registrational study expected to begin in 2026.

  2. Late 2026

    File for regulatory approval of intismeran autogene in melanoma

    File for regulatory approval of intismeran autogene (mRNA-4157) plus KEYTRUDA in adjuvant melanoma after the pivotal Phase 3 INTerpath-001 trial met both its primary endpoint (recurrence-free survival) and key secondary endpoint (distant metastasis-free survival) on August 19, 2026 - the first positive Phase 3 result ever for an individualized mRNA neoantigen cancer therapy. As of September 8, 2026 no BLA or MAA has been filed. Moderna and Merck say they will present the data at an upcoming medical meeting and engage with regulators on filing submissions.

  3. Oct 24, 2026

    Present INTerpath-001 Phase 3 melanoma data at ESMO

  4. 2027-2028

    Norovirus vaccine Phase 3 extended-cohort readout

    Moderna's Phase 3 norovirus vaccine trial (mRNA-1403, NOVA 301, ~38,000 participants) underwent its interim analysis but did not meet the statistical threshold for early success, the company disclosed on July 31, 2026 alongside Q2 earnings. The trial has already relocated across hemispheres more than once chasing enough norovirus cases; Moderna is now enrolling a fourth cohort after slower-than-expected case accrual, pushing a definitive efficacy readout to 2027-2028 at the earliest. No later public update has moved that window.

  5. 2027

    Begin Phase 2 expansion of mRNA-4194 Lynch syndrome trial

    Expand the Phase 1/2 INTERCEPT-Lynch study of mRNA-4194, Moderna's cancer-prevention vaccine for people with Lynch syndrome, into a larger Phase 2 across multiple UK centers - the next step after Phase 1 dosing began in 2026 under the UK MHRA's June 8, 2026 authorization. Moderna's public pipeline still lists the program in Phase 1 as of the May 28, 2026 pipeline cut; no later start date for the Phase 2 expansion has been announced.

03

Latest news11

  1. UK MHRA authorizes Moderna XFG Spikevax update

    The UK Medicines and Healthcare products Regulatory Agency authorized Moderna's updated Spikevax COVID-19 vaccine targeting the SARS-CoV-2 XFG variant for adults and children aged six months and older. Doses will be made at the Moderna Innovation and Technology Centre in Harwell, Oxfordshire, for the NHS 2026/27 vaccination programme. The European Medicines Agency's Emergency Task Force separately recommended that 2026/2027 COVID-19 vaccines target the XFG variant.

    PMLiVE ChemDiv

  2. Moderna prices upsized $2.6 billion convertible notes

    Moderna said on August 28, 2026 it priced an upsized $2.6 billion private offering of 0.00% convertible senior notes due 2032, up from a planned $2.0 billion, with sale to qualified institutional buyers expected to close September 1. The notes carry an initial conversion price of about $210.58 per share, a 47.5% premium to Moderna's August 27 close, and are paired with capped call transactions capped near $392.62 per share to limit potential dilution.

    AccessWire StockTitan

  3. FDA approves Moderna's updated 2026-2027 COVID vaccines

    Moderna said on August 27 that the FDA approved the 2026-2027 formulas of Spikevax and mNEXSPIKE, both targeting the JN.1-lineage XFG subvariant of SARS-CoV-2. Spikevax is cleared for high-risk people aged 6 months through 64 and all adults 65 and older, while mNEXSPIKE is cleared for high-risk people aged 12 through 64 and all adults 65 and older; the company said the shots should be available in the coming days.

    Moderna (ACCESS Newswire)

  4. Moderna to raise $2 billion in convertible senior notes

    Moderna announced on August 27 a proposed private placement of $2.0 billion of convertible senior notes due 2032, with an option for initial purchasers to buy up to $300 million more. The company plans to use proceeds to expand its oncology business, including its Merck-partnered melanoma vaccine program, and to repay existing debt, while a planned capped-call transaction aims to limit dilution; shares fell in premarket trading on the announcement.

    AccessNewswire (Moderna) Yahoo Finance

  5. Moderna-Merck melanoma vaccine hits Phase 3 goals, shares surge

    Merck and Moderna said August 19 that the Phase 3 INTerpath-001 trial of intismeran autogene (mRNA-4157) plus KEYTRUDA met both its primary endpoint of recurrence-free survival and its key secondary endpoint of distant metastasis-free survival in 1,137 patients with completely resected stage IIB-IV melanoma, the first positive Phase 3 result ever for an individualized mRNA neoantigen cancer therapy. Moderna shares surged as much as 90%+ intraday and Merck rose about 7-11%, and the companies said they plan to file for regulatory approval within months.

    Merck/Moderna (BusinessWire) NBC News

04

Products6

05

Key metrics

Employees
~4,700
Est. annual revenue
Q2 2026 revenue $145M

(up 2% YoY, above guidance); guidance of up to ~10% growth for full-year 2026, with ~55% of H2 revenue guided into Q3

FY2025 Revenue
$1.9B (down ~40% YoY)
Cash & Investments
$6.9B

(Jun 30, 2026), before the $950M litigation settlement paid in July 2026; FY2026 year-end cash still guided to $4.7-5.2B. A $2.6B zero-coupon convertible-note raise priced Aug 27, 2026 adds liquidity ahead of Q3.

Market Cap
~$60.2B

(Sept 2, 2026) - still more than double the pre-Aug 19 level after the Phase 3 melanoma-vaccine win; next earnings date Nov 5, 2026

Q2 2026 Revenue
$145M

(up 2% YoY; above high end of guidance); ~55% of H2 2026 revenue guided into Q3

Development Programs

36 development programs across 26 development candidates in clinical studies (Jun 30, 2026), incl. 9 Phase 2/3 oncology studies; company homepage separately cites 45 programs and 36 ongoing trials

Approved Products

Five commercial products: Spikevax, mNEXSPIKE, mRESVIA, mCOMBRIAX (EU), and mFlusiva (US, Aug 5, 2026) - the first FDA-approved mRNA flu shot

FY2025 R&D Spend
$3.13B (down ~31% YoY)
Cost Reductions
~$2.2B annual OpEx cut in 2025

(~$1.5B more targeted by 2027); breakeven targeted 2028

Convertible notes closed

$3.0B of 0.00% Convertible Senior Notes due 2032 closed Sept 1, 2026 ($2.6B priced Aug 27-28 plus $400M greenshoe). Initial conversion price about $210.58 (47.5% premium to $142.77 on Aug 27).

Market Cap
About $78.9B as of September 27, 2026

MarketCapLens at $198.88; September 25 close $194.82

mFlusiva US availability

More than 13,000 US locations as of September 25, 2026, per Moderna via CNN

Market Cap
About $75.86B

2 Oct 2026 close $190.01, 399.24M shares

Market Cap
About $78.65B

8 October 2026 close $197.00, 399.24M shares

06

Operations & revenue

Operating status

Commercial, pre-breakeven

Juan Andres's COO start on Oct. 5, 2026 is confirmed by Form 3 accession 0001682852-26-000183 and by the leadership pages, which list him as Chief Operating Officer and no longer list Jerh Collins. No later 10-Q has reported the start; Q3 results remain scheduled for Nov. 5. INTerpath-001 Phase 3 RFS and DMFS hazard ratios are still unpublished. The Sept. 21 release schedules LBA1 for Oct. 24, 2026 at 4:30 p.m. CEST, with an investor webcast at 7:00 p.m. CEST, and does not announce a US BLA or EU MAA. The HR 0.51 and 0.411 figures remain Phase 2b KEYNOTE-942, not INTerpath-001. Cash-flow breakeven remains targeted for 2028.

Revenue streams

  • COVID-19 vaccines

    Spikevax and next-generation mNEXSPIKE remain the dominant revenue source (the bulk of $1.8B FY2025 product sales), though sales are declining and increasingly seasonal and international. The FDA approved the 2026-2027 XFG formulas of both products on August 27, 2026.

  • RSV, flu, and combination vaccines

    mRESVIA (RSV) is a small but growing franchise, with its EU label expanded to adults 18+. mCOMBRIAX (flu+COVID combination) began generating European revenue in 2026. mFlusiva, the first FDA-approved mRNA flu shot (August 5, 2026), is expected in the US for the 2026-2027 season, with reviews open in the EU, Canada and Australia.

  • Collaborations & grants

    About $126M of FY2025 'other revenue' came from collaborations and grants, including Merck's ~50% cost-share on the intismeran cancer-vaccine program, licensing, and government funding.

07

Track record

How past announced dates turned out.

3/4announced dates hit on time

  • 3 Hit
  • 1 Slipped
  • 0 Missed
  1. Hit

    Juan Andres starts as Chief Operating Officer

    Target October 5, 2026 · Resolved Oct 5, 2026

    Form 3 filed Oct. 5, 2026, period of report Oct. 5, 2026, lists Juan Andres as Chief Operating Officer. The company and investor leadership pages now list him in that role and no longer list Jerh Collins. No 10-Q after the start date was on file; Q3 results are scheduled for Nov. 5.

  2. Hit

    Melanoma cancer-vaccine Phase 3 readout

    Target 2026–2027 · Resolved Aug 19, 2026

    The Phase 3 INTerpath-001 trial of intismeran autogene (mRNA-4157) plus KEYTRUDA met both its primary endpoint (recurrence-free survival) and key secondary endpoint (distant metastasis-free survival) in 1,137 patients with completely resected stage IIB-IV melanoma, the first positive Phase 3 readout ever for an individualized mRNA neoantigen cancer therapy. Moderna shares surged as much as 90%+ intraday and Merck shares rose about 7-11% on the news.

  3. Hit

    FDA decision on mRNA flu vaccine (mRNA-1010)

    Target Aug 2026 · Resolved Aug 5, 2026

    The FDA approved mFlusiva (mRNA-1010) on August 5, 2026 for adults 50 and older, with the 65+ indication under accelerated approval pending a postmarketing study, making it Moderna's fourth approved respiratory product.

  4. Slipped

    Norovirus vaccine Phase 3 interim analysis

    Target 2026 (timing at risk) · Resolved Jul 31, 2026

    The interim analysis was conducted but did not meet the statistical threshold for early success; Moderna is enrolling an additional cohort and now expects a definitive efficacy readout in 2027-2028.

08

Timeline27

  1. 2026

    1. Juan Andres starts as Chief Operating Officer

      On October 5, 2026 Juan Andres became Chief Operating Officer, the date in his Form 3 and in the September 30 appointment. The company leadership page and the investor leadership page now list him as COO. Jerh Collins is no longer on either executive list. No later 10-Q was available because third-quarter results are still scheduled for November 5.

    2. Creates COO role; Juan Andres returns; Jerh Collins to retire

      On September 30, 2026 Moderna announced a new Chief Operating Officer role and appointed Juan Andres, effective October 5, 2026. Andres previously served as Chief Technical Operations and Quality Officer from 2018 through 2022 and as President, Strategic Partnerships and Enterprise Expansion before retiring in 2023. He will report to CEO Stephane Bancel, serve on the Executive Committee, and lead manufacturing. The company tied the role to preparing for potential launch and scale-up of intismeran autogene and a five-product infectious-disease franchise. Chief Technical Operations and Quality Officer Jerh Collins, who joined in October 2022 and became CTOQ in January 2023, has decided to retire. Offer-letter terms include an $800,000 base salary, a 90 percent target annual bonus (pro-rated for 2026), and a $5 million new-hire equity award with four-year vesting. The offer letter itself is to be filed with a future periodic report.

    3. Schedules INTerpath-001 Phase 3 data for ESMO Presidential Symposium

      On September 21, 2026 Moderna said INTerpath-001 Phase 3 melanoma results (intismeran autogene plus pembrolizumab versus pembrolizumab alone in resected stage IIB-IV melanoma) will be presented as late-breaking abstract LBA1 in the ESMO Congress 2026 Presidential Symposium on October 24 at 4:30 p.m. CEST in Madrid by Georgina V. Long. Two additional intismeran posters cover a Phase 1 pancreatic study on October 25 and the INTerpath-014 Stage I NSCLC trial-in-progress on October 26. Phase 3 hazard ratios remain unpublished, and no BLA or MAA has been announced.

    4. Closes $3.0B zero-coupon convertible notes offering

      Moderna closed its private offering of $3.0B aggregate principal amount of 0.00% Convertible Senior Notes due 2032, including full exercise of the $400M initial-purchaser option on top of the $2.6B priced August 27-28. Net proceeds were about $2,957.3M; $328.8M was used for capped-call transactions. The notes are senior unsecured, mature March 1, 2032, convert initially at about $210.58/share (4.7487 shares per $1,000), and may be settled in cash, stock, or a combination at Moderna's election. Remaining proceeds are for general corporate purposes, including oncology investment and possible debt repayment.

    5. UK MHRA authorizes XFG Spikevax for ages 6 months+

      The UK Medicines and Healthcare products Regulatory Agency authorized Moderna's updated Spikevax COVID-19 vaccine targeting the SARS-CoV-2 XFG variant for adults and children aged six months and older. Doses will be manufactured at the Moderna Innovation and Technology Centre in Harwell, Oxfordshire, for the NHS 2026/27 vaccination programme. The EMA Emergency Task Force separately recommended that 2026/2027 COVID-19 vaccines target XFG.

    6. FDA approves 2026-2027 XFG Spikevax and mNEXSPIKE formulas

      On August 27, 2026 the FDA approved the 2026-2027 formulas of Spikevax and mNEXSPIKE, both targeting the JN.1-lineage XFG subvariant of SARS-CoV-2. Spikevax is cleared for high-risk people aged 6 months through 64 and all adults 65 and older; mNEXSPIKE is cleared for high-risk people aged 12 through 64 and all adults 65 and older. Moderna said the updated shots should be available in the coming days.

    7. Phase 1 trial opens for combined RSV/hMPV vaccine

      Moderna starts a Phase 1 randomized, dose-escalation trial of mRNA-1365 (Profile 2), a multicomponent vaccine targeting both RSV and human metapneumovirus in a single shot for adults 60 and older, first submitted to the clinical trial registry on August 10, 2026. The study compares the combination candidate's safety and immune response against two versions of Moderna's already-approved single-pathogen RSV vaccine mRESVIA, broadening the respiratory-vaccine pipeline beyond COVID-19 and standalone RSV shots.

    8. Phase 3 melanoma vaccine trial meets primary and secondary endpoints

      The Phase 3 INTerpath-001 trial of intismeran autogene (mRNA-4157) plus KEYTRUDA meets both its primary endpoint of recurrence-free survival and its key secondary endpoint of distant metastasis-free survival in 1,137 patients with completely resected stage IIB-IV melanoma, announced August 19, 2026 - the first positive Phase 3 result ever for an individualized mRNA neoantigen cancer therapy. Moderna and Merck say they plan to file for regulatory approval within months.

09

Funding

$8.7Bdisclosed across 6 rounds with a stated amount

Cumulative disclosed raise · dated rounds

$5B$10B20132016201920222025$8.7B raised
  1. Series E

    2015

    $450M

    Flagship Pioneering, crossover institutional investors

  2. Late-stage private rounds

    2016–2017

    ~$1B+

    Flagship Pioneering, Gates Foundation, sovereign and institutional investors

  3. IPO (NASDAQ: MRNA)

    2018

    $621M

    Public markets

  4. Non-dilutive (government & foundations)

    2013–2021

    ~$1B+

    DARPA, BARDA/Operation Warp Speed (~$955M), CEPI, Gates Foundation

  5. Convertible senior notes (due 2032)

    Aug 2026

    $2.6B (0.00% coupon, upsized from a planned $2.0B)

    Private placement to qualified institutional buyers; initial conversion price ~$210.58/share (47.5% premium to the Aug 27, 2026 close), paired with capped call transactions capped near $392.62/share

  6. Convertible senior notes due 2032 (close, including greenshoe)

    2026-09-01

    $3.0B aggregate principal (0.00% coupon)

    Rule 144A private placement to qualified institutional buyers. $2.6B priced Aug 27-28, 2026 plus $400M initial-purchaser option exercised in full. Net proceeds about $2,957.3M; $328.8M used for capped calls (initial cap about $392.62/share). Initial conversion price about $210.58 (47.5% premium to the Aug 27 close of $142.77). Matures March 1, 2032.

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