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Moderna

42°21′48″N71°05′28″W/ 42.3633°N 71.091°W/42.3633; -71.091

Moderna, Inc.
FormerlyModeRNA Therapeutics
(2010–2018)
Company typePublic
ISINUS60770K1079
IndustryBiotechnology
FoundedSeptember 2010;14 years ago(2010-09)
Founders
Headquarters200Technology Square
Cambridge, Massachusetts,U.S.
Key people
Products
RevenueDecreaseUS$6.848 billion(2023)
DecreaseUS$−4.24 billion(2023)
DecreaseUS$−4.71 billion(2023)
Total assetsDecreaseUS$18.43 billion(2023)
Total equityDecreaseUS$13.85 billion(2023)
Owners
Number of employees
5,600 (2023)
Websitemodernatx
Footnotes / references
[1][2][3]

Moderna, Inc.(/məˈdɜːrnə/mə-DUR-nə)[4]is an American pharmaceutical andbiotechnologycompany based inCambridge, Massachusetts,that focuses onRNA therapeutics,primarilymRNA vaccines.Thesevaccinesuse a copy of a molecule calledmessenger RNA(mRNA) to carry instructions for proteins to produce animmune response.[5][1]The company's name is derived from the terms "modified", "RNA", and "modern".[6][7][8]

The company's commercial products are theModerna COVID-19 vaccine,marketed as Spikevax and a RSV vaccine, marketed as Mresvia. The company has 44 treatment and vaccine candidates, of which 37 have enteredclinical trials.Candidates include possible vaccines forinfluenza,HIV,Epstein–Barr virus,theNipah virus,chikungunya,human metapneumovirus,varicella zoster virus,as well as acyt Omega lovirus vaccine,aZika virus vaccinefunded by theBiomedical Advanced Research and Development Authority,and threecancer vaccines.The company's pipeline also includes acell therapy-based treatment: arelaxinfusion proteinbeing developed to treatacute decompensated heart failure.It also includes candidates that useOX40 ligand,interleukin 23,IL36G,andinterleukin 12forcancer immunotherapy,specifically treatment ofbreast cancer,urothelial carcinoma,lymphoma,andmelanoma.Also being developed by Moderna is aregenerative medicinetreatment that encodesvascular endothelial growth factor Ato stimulateblood vesselgrowth for patients withmyocardial ischemia.[1][failed verification]

History

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Moderna was founded in 2010 byDerrick Rossi,Timothy A. Springer,Kenneth R. Chien,Robert S. Langer,andNoubar Afeyan.[9]Stéphane Bancel,the current CEO, was appointed as CEO in 2011.[6][10]Between 2011 and 2017, Moderna raised $2billion inventure capitalfunding.[7][8]

In November 2024, Moderna Inc. announced that Stéphane Bancel, currently serving as Chief Executive Officer, will step down from his role as Chief Commercial Officer while continuing as CEO. Moderna's President, Stephen Hoge, will take over responsibilities for the company's sales, medical, and research affairs.[11]

Product development

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In 2013, the company formed a partnership withAstraZenecato develop treatments for cardiovascular, metabolic, and renal diseases, as well as cancer. Moderna was also awarded a $25,000,000 grant by DARPA through a program Autonomous Diagnostics to Enable Prevention and Therapeutics: Prophylactic Options to Environmental and Contagious Threats (ADEPT-PROTECT). Its stated goal was to develop an mRNA vaccine with the capability to suppress a global pandemic within 60 days. In January 2014, the company entered an agreement withAlexion Pharmaceuticalsto develop treatments against ten diseases.[12]On January 14, 2014, Moderna announced the creation of its first venture, Onkaido Therapeutics, to focus "exclusively on developing mRNA-based oncology treatments."[13][14]It launched its second venture, Valera, in January 2015, with a focus on "viral, bacterial and parasitic infectious diseases."[15][16]Employees of Valera and Moderna developed an mRNA vaccine candidate againstZika virusinfection.[17]Another venture, Elpidera, was announced in May 2015 to continue work on RNA therapies advancing Moderna's work with Alexion.[18][19]

In 2015, the company formed a partnership withMerck & Co.to develop treatments for cancer, and in 2016 the company formed a partnership withVertex Pharmaceuticalsto develop treatments forcystic fibrosis.[10][20][21][22]In January 2016, theBill & Melinda Gates Foundationcommitted to provide at least $20 million ingrantfunding to the company.[1]In 2017, Alexion terminated its partnership with Moderna after safety issues prevented their work from reaching human trials.[23]

In July 2018, the company opened a 200,000 square foot facility inNorwood, Massachusettsfor manufacturing, preclinical and clinical work.[24]In December 2018, Moderna became apublic companyvia the largestinitial public offeringof a biotechnology company in history, raising $621million by selling 27 million shares at $23 per share.[25][26]

The first mRNA vaccine developed by Moderna was forinfluenzain 2015, and its firstantibodyencoded by mRNA was in 2019.[6]In 2023, Moderna acquired OriCiro Genomics, a Japanese manufacturer ofgenetic engineeringtools, in its first acquisition.[27]

In early 2023, the company in collaboration withMerckwonbreakthrough statusfrom the FDA for itsmRNA-4157/V940drug candidate, acancer vaccine.[28][29]

In July 2023, the company entered into an agreement with the Chinese government to develop mRNA drugs for exclusive use inChina.[30]

In May 2024, the mRNA vaccine Mresvia was approved for medical use in the United States by the USFood and Drug Administration(FDA) for the prevention of lower respiratory tract disease caused byrespiratory syncytial virusin individuals 60 years of age and older,[31][32]the thirdRSV vaccineapproved in the United States.

COVID-19 vaccine

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Main article:Moderna COVID-19 vaccine

From 2020 to 2021, Moderna received $955million fromOperation Warp Speedto accelerate development of its COVID-19 vaccine, with $4.9billion committed in total for producing 300 million vaccine doses.[33][34]

In March 2020, theFood and Drug Administrationapprovedclinical trialsfor theModerna COVID‑19 vaccinecandidate, and in December, the vaccine, mRNA-1273, was issued anemergency use authorizationin the United States.[35][36]In 2022, it gained FDA approval both for themonovalent vaccine,Spikevax,and a bivalentbooster.[37]

In April 2022, Moderna announced plans to build a $180 million vaccine factory inMontreal,forming a 10-year partnership with theGovernment of Canada,Quebec,andMcGill Universityto produce 100 millionSpikevaxdoses annually and expand vaccine research capabilities.[38]The plant is scheduled to supply COVID-19 vaccines in the fall of 2025.[39]

In February 2023, the company agreed to pay $400 million to theNational Institutes of Health,Dartmouth College,andScripps Researchto settle a dispute over the rights to a chemical technique that was used in the vaccine.[40]

Arbutus Biopharmafiled a patent infringement lawsuit against Moderna in 2022, alleging that Arbutus developed lipid nanoparticles that enclose Modern'a vaccine's mRNA payload.[41]In April 2023, a court affirmed a decision to cancel a patent byArbutus Biopharmain connection with the dispute.[42]In April 2024, however, the court issued an order that strengthened Arbutus's arguments by interpreting patents at issue in the manner Arbutus had urged.[41]

Several legal cases between Moderna andPfizerandBioNTechin various countries, alleging that thePfizer–BioNTech COVID-19 vaccineviolates the patent on Moderna'smRNA vaccinetechnology, are ongoing.[43]

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In November 2024, British pharmaceutical companyGlaxoSmithKline (GSK)filed a lawsuit against Moderna Inc. in a U.S. federal court inDelaware,alleging that Moderna's COVID-19 vaccineSpikevaxand RSV vaccine mResvia infringe on GSK’s patents related to messenger RNA (mRNA) technology. According to the complaint, Moderna's use of lipid nanoparticles—crucial for delivering fragile mRNA into the human body—violates several GSK patents covering similar delivery innovations.[44]

This lawsuit follows a similar legal action GSK brought against Pfizer and BioNTech earlier in 2024, claiming patent infringement over their mRNA-based COVID-19 vaccine. GSK’s latest litigation seeks unspecified monetary damages from Moderna.[44]

Rare disease therapeutics

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Financial data

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Year Revenue
(mln. US$) 		Net income (loss)
(mln. US$)
2019[1] 60 (514)
2020[1] 803 (747)
2021[1] 18,471 12,202
2022[1] 19,263 8,362
2023[1] 6,848 (4,710)
2024[1] 3,200 (3,600)

See also

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References

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  1. ^abcdefghij"Moderna, Inc., 2023, Form 10-K Annual Report".U.S. Securities and Exchange Commission.February 23, 2024.
  2. ^"Moderna, Inc. Schedule 14A 2022 Proxy Statement".U.S. Securities and Exchange Commission.March 9, 2022.
  3. ^"Key Facts".Moderna.
  4. ^Moderna (October 23, 2019).mRNA-3704 and Methylmalonic Acidemia(video) – viaYouTube.
  5. ^Park KS, Sun X, Aikins ME, Moon JJ (December 2020)."Non-viral COVID-19 vaccine delivery systems".Advanced Drug Delivery Reviews.169:137–51.doi:10.1016/j.addr.2020.12.008.PMC7744276.PMID33340620.
  6. ^abc"Moderna, Our story; Our big moments".Moderna, Inc. 2023.RetrievedFebruary 10,2023.
  7. ^abGarde D, Saltzman J (November 10, 2020)."The story of mRNA: How a once-dismissed idea became a leading technology in the Covid vaccine race".Stat.Archivedfrom the original on November 10, 2020.
  8. ^abServick K (March 25, 2020)."This mysterious $2 billion biotech is revealing the secrets behind its new drugs and vaccines (from the original, 1 February 2017)".Science.doi:10.1126/science.aal0686.S2CID241466550.
  9. ^Elton C (March 2013)."The NEXT Next Big Thing".Boston Magazine.Archivedfrom the original on November 16, 2020.
  10. ^abGarde D (September 13, 2016)."Ego, ambition, and turmoil: Inside one of biotech's most secretive startups".Stat.Archivedfrom the original on November 16, 2020.
  11. ^"Moderna's Bancel Steps Down as Sales Chief, Keeps CEO Role".Bloomberg.November 5, 2024.RetrievedNovember 8,2024.
  12. ^Reidy C (January 13, 2014)."Alexion, Moderna announce agreement to develop messenger RNA therapeutics".Boston Globe Media Partners.Archivedfrom the original on July 2, 2021.RetrievedJune 5,2023.
  13. ^"Moderna Launches Onkaido Therapeutics to Focus on the Development of mRNA Therapeutics™ in Oncology with $20 Million Capital Commitment"(Press release).PR Newswire.January 14, 2014.Archivedfrom the original on November 20, 2016.
  14. ^Gormley B (January 15, 2014)."Moderna Launches Cancer Drug Co. Onkaido Therapeutics With $20M Investment".Wall Street Journal.ISSN0099-9660.Archived fromthe originalon June 5, 2023.RetrievedJune 5,2023.
  15. ^"Moderna Launches New Venture Valera LLC for Infectious Diseases"(Press release).PR Newswire.January 8, 2015.Archivedfrom the original on November 19, 2016.
  16. ^"Moderna Launches New Venture Valera LLC for Infectious Diseases".Bionity.January 12, 2015.Archivedfrom the original on June 5, 2023.RetrievedJune 5,2023.
  17. ^Richner JM, Himansu S, Dowd KA, Butler SL, Salazar V, Fox JM, Julander JG, Tang WW, Shresta S, Pierson TC, Ciaramella G, Diamond MS (February 17, 2017)."Modified mRNA Vaccines Protect against Zika Virus Infection".Cell.168(6): 1114–1125.e10.doi:10.1016/j.cell.2017.02.017.ISSN0092-8674.PMC5388441.PMID28222903.
  18. ^"Moderna Launches Third Venture Company Elpidera for Rare Diseases"(Press release).PR Newswire.May 12, 2015.Archivedfrom the original on October 12, 2016.
  19. ^Tirrell M (May 12, 2015)."The biotech targeting personalized medicine".CNBC.Archivedfrom the original on April 10, 2021.RetrievedJune 5,2023.
  20. ^Weisman R (March 21, 2013)."Moderna in line for $240m licensing deal".The Boston Globe.Archivedfrom the original on November 16, 2020.
  21. ^"Moderna: Strategic collaborators".Moderna, Inc. 2023.RetrievedFebruary 11,2023.
  22. ^"Vertex and Moderna hammer out $315 million+ deal to treat cystic fibrosis using mRNA technology".BioSpace. July 6, 2016.RetrievedFebruary 11,2023.
  23. ^Garde D (July 27, 2017)."Key partner cuts ties with brash biotech startup Moderna, raising big questions about its pipeline".Stat.
  24. ^DeAngelis A (July 17, 2018)."Moderna's $110M Norwood site built with expansion hopes".American City Business Journals.
  25. ^Mukherjee S (December 8, 2018)."Moderna Had the Biggest Biotech IPO Ever. Here's What That Says About the Industry's Future".Fortune.Archivedfrom the original on November 16, 2020.
  26. ^Ramsey L (December 7, 2018)."Moderna just priced the biggest IPO in biotech history, valuing the startup at $7.5 billion".Business Insider.Archivedfrom the original on November 16, 2020.
  27. ^Schmidt H (January 5, 2023)."Moderna to Buy Japanese Firm OriCiro in Its First-Ever Acquisition".PharmaNews Intelligence.
  28. ^"Precision medicine meets cancer vaccines".Nature Medicine.29(6): 1287. June 16, 2023.doi:10.1038/s41591-023-02432-2.PMID37328586.S2CID259184146.
  29. ^Bafaloukos D (2023)."Evolution and Progress of mRNA Vaccines in the Treatment of Melanoma: Future Prospects".Vaccines.11(3): 636.doi:10.3390/vaccines11030636.PMC10057252.PMID36992220.
  30. ^Kuchler H, Mancini DP (July 5, 2023)."US biotech Moderna strikes deal to develop mRNA drugs in China".Financial Times.
  31. ^"Moderna Receives U.S. FDA Approval for RSV Vaccine Mresvia"(Press release). Moderna. May 31, 2024.RetrievedMay 31,2024– via Accesswire.
  32. ^"FDA Roundup: May 31, 2024".U.S.Food and Drug Administration(FDA)(Press release). May 31, 2024.RetrievedMay 31,2024.This article incorporates text from this source, which is in thepublic domain.
  33. ^Valverde M (November 19, 2020)."How Pfizer's and Moderna's COVID-19 vaccines are tied to Operation Warp Speed".PolitiFact.RetrievedFebruary 12,2023.
  34. ^Siddalingaiah SV (March 1, 2021)."Operation Warp Speed Contracts for COVID-19 Vaccines and Ancillary Vaccination Materials".Congressional Research Service, United States Government.RetrievedFebruary 12,2023.
  35. ^"Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine".National Institutes of Health.December 18, 2020.
  36. ^Ledford H (December 18, 2020)."Moderna COVID vaccine becomes second to get US authorization".Nature.doi:10.1038/d41586-020-03593-7.PMID33340017.S2CID243212854.RetrievedFebruary 12,2023.
  37. ^"Moderna COVID-19 vaccines".US Food and Drug Administration. December 15, 2022.RetrievedFebruary 11,2023.
  38. ^"Moderna facility in Montreal area expected to produce 100 million vaccine doses by 2024".CBC News.April 29, 2022.
  39. ^"Moderna will supply COVID-19 vaccines made in Laval by fall 2025".The Gazette.
  40. ^Mueller B (February 23, 2023)."After Long Delay, Moderna Pays N.I.H. for Covid Vaccine Technique".The New York Times.
  41. ^ab"Moderna shares fall after judge sides with Arbutus in patent fight".Reuters.April 3, 2024.RetrievedMay 19,2024.
  42. ^Brittain B (April 11, 2023)."Moderna fends off Arbutus appeal in COVID-19 vaccine patent fight".Reuters.
  43. ^Robbins R, Gross J (August 26, 2022)."Moderna Sues Pfizer and BioNTech Over Covid Vaccine Technology".The New York Times.ISSN0362-4331.
  44. ^abBrittain B (October 16, 2024)."GSK sues Moderna for US patent infringement over COVID, RSV vaccines".Reuters.RetrievedNovember 8,2024.
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