PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights certain information about us, this offering and selected information contained elsewhere in or incorporated by reference into this prospectus supplement. This summary is not complete and does not contain all of the information that you need to consider in making your investment decision. For a more complete understanding of our company and this offering, you should read and consider carefully the more detailed information included or incorporated by reference in this prospectus supplement and the accompanying prospectus, including the factors described under the heading “Risk Factors” of this prospectus supplement, in our Annual Report on Form 20-F filed with the SEC on March 3, 2022 and in our other filings that are incorporated by reference into this prospectus supplement and the accompanying prospectus, as well as the information included in any free writing prospectus that we have authorized for use in connection with this offering.
Company Overview
We are a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor, or TCR, bispecific immunotherapies called ImmTAX - Immune mobilizing monoclonal TCRs Against X disease - designed to treat a broad range of diseases, including cancer, infectious and autoimmune diseases. Leveraging our proprietary, flexible, off-the-shelf ImmTAX platform, we are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Our lead product, KIMMTRAK, is a first-in-class TCR therapeutic approved for the treatment of patients with unresectable or metastatic uveal melanoma, or mUM, in the United States, European Union, Canada, Australia, and the United Kingdom, with commercial launches underway in the United States and Germany, and paid access in France.
We have three clinical stage programs within our ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) platform, including KIMMTRAK. Our clinical programs are being conducted with patients with a broad range of cancers including melanoma, lung, gastric, head and neck and ovarian, among others. As of August 31, 2022, we have dosed over 800 cancer patients with our ImmTAX product candidates, which we believe is the largest clinical data set of any bispecific in a solid tumor and any TCR therapeutic. Our ImmTAX product candidates have the potential to address other tumor types with larger addressable patient bispecific therapeutic populations and significant unmet need, and we are studying the application of our ImmTAX platform to infectious diseases and autoimmune conditions.
Our Lead Product - KIMMTRAK
On January 26, 2022, we announced the U.S. Food and Drug Administration, or the FDA, approved KIMMTRAK (tebentafusp-tebn) for the treatment of patients with unresectable or mUM. KIMMTRAK is the first TCR therapeutic and first bispecific T cell engager to receive approval from the FDA to treat a solid tumor, and the first and only therapy for the treatment of unresectable or mUM to be approved by the FDA.
On April 1, 2022, the European Commission, or EC, approved KIMMTRAK (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or mUM. With EC approval, KIMMTRAK has received marketing authorization in all European Union member states, and following completion of related national procedures, will also be eligible for sale in Iceland, Liechtenstein, and Norway. In addition, the United Kingdom’s Medicines and Healthcare Regulatory Agency, or MHRA, Health Canada, and Australia’s Department of Health Therapeutic Goods Administration, or TGA, have each approved KIMMTRAK for the treatment of unresectable or mUM.
KIMMTRAK is manufactured at facilities located in Denmark and Germany. We are supporting the appropriate use of KIMMTRAK in the United States, Germany and France through a fit-for-purpose commercial team that includes medical, sales, and value access team members. We utilize a hybrid model that includes in-house and contracted resources in the United States and Europe. KIMMTRAK commercial supply was made available in the United States and Germany shortly after regulatory approval for the treatment of patients with unresectable or mUM. We also launched a payer program called KIMMTRAKConnect with the goal to help ensure patients in the United States have access to KIMMTRAK, including financial assistance, personalized support and education, and site of care coordination for eligible patients. In May, the first patient in Germany was infused with KIMMTRAK, less than one week from price listing, and the Company successfully transitioned all (more than 50) patients from the early access program, or EAP, in Germany onto commercial supply. Our commercial