Arcturus Therapeutics

Arcturus Therapeutics
Name	Arcturus Therapeutics
Type	Public
Industry	Biotechnology
Founded	2013
Headquarters	San Diego, California
Key people	Joseph E. Payne, Kamran Khan
Products	mRNA therapeutics, LUNAR lipid nanoparticles
Revenue	(see Financial performance)
Website	(company website)

Arcturus Therapeutics is a biotechnology company focused on messenger RNA therapeutics and vaccines, lipid nanoparticle delivery systems, and rare disease treatments. The company has engaged with academic institutions, pharmaceutical companies, and regulatory agencies to advance mRNA platforms for infectious diseases and genetic disorders. Its work connects with research communities in mRNA biology, lipid chemistry, and clinical development.

Company overview

Arcturus Therapeutics is based in the San Diego region and operates within the biotechnology and pharmaceutical sectors, interacting with organizations such as National Institutes of Health, Food and Drug Administration, European Medicines Agency, Massachusetts Institute of Technology, Harvard University, University of California, San Diego, Johns Hopkins University, Stanford University, Cold Spring Harbor Laboratory, Scripps Research, Imperial College London, University of Oxford, University of Cambridge, Karolinska Institutet, Ragon Institute, Whitehead Institute, Broad Institute, Rockefeller University, Wellcome Trust, Bill & Melinda Gates Foundation, Gates Cambridge Scholarship, Howard Hughes Medical Institute, National Science Foundation, DARPA, Wellcome Sanger Institute, European Commission, World Health Organization, Bill & Melinda Gates Foundation Grand Challenges, GAVI, the Vaccine Alliance, CEPI, Pfizer, Moderna, BioNTech, CureVac, Regeneron Pharmaceuticals, Roche, GlaxoSmithKline, Sanofi, AstraZeneca, Johnson & Johnson, Merck & Co., Eli Lilly and Company, Novartis, Bristol-Myers Squibb, Takeda Pharmaceutical Company, Eli Lilly, Amgen, Bayer, AbbVie.

History and development

Founded in 2013, the company evolved amid advances from institutions like University of Pennsylvania, Yale University, Columbia University, University of Oxford, McMaster University, King's College London, University of Toronto, University of British Columbia, Australian National University, Monash University, University of Melbourne, Seoul National University, Peking University, Tsinghua University, Shanghai Jiao Tong University, National University of Singapore, Nanyang Technological University, KAUST, ETH Zurich, École Polytechnique Fédérale de Lausanne, Max Planck Society, Francis Crick Institute, Pasteur Institute, Institut Pasteur Korea, Riken, Zhejiang University, Fudan University, Tokyo University and responded to global efforts during the SARS-CoV-2 pandemic alongside companies such as Moderna, BioNTech, Pfizer, CureVac and Novavax. Leadership changes, collaborations, and equity events connected the company with investors including Goldman Sachs, Morgan Stanley, JPMorgan Chase, BlackRock, Vanguard Group, Sequoia Capital, OrbiMed Advisors, Perceptive Advisors, Sofinnova Partners, New Enterprise Associates, ARCH Venture Partners, Versant Ventures, Third Rock Ventures, Flagship Pioneering, Atlas Venture, Horizon Ventures, Temasek Holdings, SoftBank Vision Fund, Tencent.

Products and pipeline

The product portfolio emphasizes mRNA vaccines and therapeutic candidates using proprietary lipid nanoparticle delivery, competing conceptually with platforms from Moderna, BioNTech, Pfizer–BioNTech vaccine, CureVac, Translate Bio, Sanofi Pasteur, AstraZeneca vaccine, Novavax vaccine, GSK vaccine and gene therapy approaches from Spark Therapeutics, Bluebird Bio, Sarepta Therapeutics, Editas Medicine, CRISPR Therapeutics, Intellia Therapeutics, Beam Therapeutics, MediGene, UniQure, AveXis. Specific pipeline areas include infectious disease vaccines, rare genetic disorders such as ornithine transcarbamylase deficiency and other metabolic disorders, and potential oncology immunotherapy concepts informed by work at Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, Fred Hutchinson Cancer Research Center, Cleveland Clinic, Mayo Clinic, Sheffield Teaching Hospitals, Royal Marsden Hospital.

Manufacturing and technology

Manufacturing capabilities have involved sterile fill-finish, lipid nanoparticle formulation, and GMP-scale RNA synthesis interacting with contract manufacturers and service providers including Thermo Fisher Scientific, Catalent, Lonza Group, WuXi AppTec, Samsung Biologics, Boehringer Ingelheim, Recipharm, Fujifilm Diosynth Biotechnologies, Patheon, IDT Biologics, Charles River Laboratories, KBI Biopharma, Catalent Biologics, Byondis, Santen Pharmaceutical, WuXi Biologics, Sartorius AG, GE Healthcare Life Sciences, Merck KGaA, Agilent Technologies. The company’s LUNAR lipid nanoparticle technology aligns conceptually with lipid systems studied at MIT Koch Institute, Harvard Wyss Institute, Pistoia Alliance, European Medicines Agency, EMA Committee for Medicinal Products for Human Use, and engages with standards from International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Pharmacopeia standards bodies and manufacturing guidelines from World Health Organization.

Financial performance and corporate affairs

Public market activity connected the company to exchanges and investor communities including Nasdaq, New York Stock Exchange, London Stock Exchange, NASDAQ Composite, S&P 500, Russell 2000 Index, FTSE 100, Dow Jones Industrial Average, MSCI World Index, Morningstar, Bloomberg L.P., Thomson Reuters, Reuters, The Wall Street Journal, Financial Times, The New York Times, The Economist, Forbes, Barron's, CNBC, Bloomberg News, Seeking Alpha, Investor's Business Daily, MarketWatch, Yahoo Finance, Google Finance, Nasdaq Investor Relations and financial regulators like Securities and Exchange Commission and Financial Conduct Authority. Revenue, R&D spending, cash runway, and share issuance have influenced strategic choices and collaborations with pharmaceutical partners and investors cited above.

Regulatory interactions and clinical trials

Clinical development and regulatory interactions involved trial registries and agencies such as ClinicalTrials.gov, Food and Drug Administration, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Health Canada, Therapeutic Goods Administration, Pharmaceuticals and Medical Devices Agency, World Health Organization, National Institutes of Health, Centers for Disease Control and Prevention, European Centre for Disease Prevention and Control, and academic clinical centers including Massachusetts General Hospital, Brigham and Women's Hospital, Mount Sinai Hospital, University College London Hospitals, Guy's and St Thomas' NHS Foundation Trust, Singapore General Hospital, Royal Prince Alfred Hospital, Sheba Medical Center, King's College Hospital, Addenbrooke's Hospital. Trials have encompassed phase 1/2 studies, safety and immunogenicity endpoints, and engagements with data monitoring committees and institutional review boards such as those at Johns Hopkins Hospital, NYU Langone Health, UCLA Health, University of Pennsylvania Health System.

Partnerships and collaborations

Collaborations include academic partnerships, strategic alliances with pharmaceutical companies, and funding relationships with philanthropic and government entities such as Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations, Biomedical Advanced Research and Development Authority, Department of Defense, Defense Advanced Research Projects Agency, Wellcome Trust, CEPI, GAVI, the Vaccine Alliance, National Institutes of Health, European Commission Horizon 2020, Innovate UK, and industrial partners like Pfizer, Moderna, BioNTech, Sanofi, GlaxoSmithKline, AstraZeneca, Novartis, Roche, Merck & Co., Johnson & Johnson, Catalent, Lonza, WuXi AppTec, Thermo Fisher Scientific. Academic collaborators include University of California, San Diego, Harvard University, Massachusetts Institute of Technology, Stanford University, University of Oxford, Imperial College London, Scripps Research Institute, Cold Spring Harbor Laboratory, Broad Institute and clinical centers listed earlier.

Category:Biotechnology companies