ADDED
o Yes x No The aggregate market value of the voting and non-voting ordinary shares held by non-affiliates of the registrant, based upon $31.38, the closing price of the registrant s American Depositary Shares on the Nasdaq Global Market on June 30 2025 (the last business day of the registrant s most recently completed second fiscal quarter) was approximately $ 1.5 billion .
As of January 31, 2026 , the registrant had 50,695,078 ordinary shares (including ordinary shares in the form of American Depositary Shares) outstanding, par value 0.002, shares consisting of 49,960,681 voting ordinary shares and 734,397 non-voting ordinary shares.
We may be unable to successfully complete additional large-scale, pivotal clinical trials for any product candidates we develop.
KIMMTRAK is now approved in 39 countries and the Company has commercially launched the product in 30 countries, including the United States, Germany and France, among other territories.
To support our commercialization efforts, we have an exclusive multi-regional collaboration with Medison Pharma Ltd.
("Medison") to help seek regulatory authorization and commercialize KIMMTRAK in Canada, Australia, New Zealand, Israel, Central and Eastern Europe, South and Central America and the Caribbean and we have entered into a distribution and commercialization agreement with Er-Kim Pharmaceuticals Bulgaria EOOD ("Er-Kim") for commercialization of KIMMTRAK in Turkey, the Middle East, North Africa, Caucasus, and the Commonwealth of Independent States regions.
In infectious diseases, we are currently evaluating IMC-M113V, in Phase 1 clinical trials for a potential functional cure in human immunodeficiency virus ("HIV").
Brenetafusp, a PRAME-targeted candidate, is being evaluated in an ongoing Phase 3 registrational trial, PRISM-MEL-301, in first-line advanced cutaneous melanoma, and we are enrolling patients in multiple expansion arms of the Phase 1/2 clinical trial.
We expect the Phase 3 trial to complete patient enrollment in the first half of 2026 with topline data expected as early as the second half of 2026.
This is a global trial led by the European Organisation for Research and Treatment of Cancer ("EORTC") and randomization is ongoing.
REMOVED
o Yes x No The aggregate market value of the voting and non-voting ordinary shares held by non-affiliates of the registrant, based upon $33.89, the closing price of the registrant s American Depositary Shares on the Nasdaq Global Market on June 28, 2024 (the last business day of the registrant s most recently completed second fiscal quarter) was approximately $ 1.6 billion .
As of January 31, 2025 , the registrant had 50,068,126 ordinary shares (including ordinary shares in the form of American Depositary Shares) outstanding, par value 0.002, shares consisting of (i) 49,333,729 voting ordinary shares and 734,397 non-voting ordinary shares.
We may be unable to successfully complete additional large-scale, pivotal clinical trials for any product candidates we develop after KIMMTRAK in mUM.
KIMMTRAK is now approved in 39 countries for the treatment of unresectable or mUM.
In 2024, we launched KIMMTRAK in 14 additional countries (including Australia, Spain, Poland, and the United Kingdom excluding Scotland, and, reached price agreements with England's National Institute for Clinical Excellence ("NICE"), with further commercial launches planned in additional territories where KIMMTRAK is approved.
To support our commercialization efforts, we have entered into an exclusive multi-regional agreement with Medison Pharma Ltd.
("Medison") to help seek regulatory authorization and commercialize KIMMTRAK in Canada, Australia, New Zealand, Israel, Central and Eastern Europe, South and Central America, and the Caribbean.
In 2024, we submitted a clinical trial application ("CTA") for IMC-T119C (PRAME-A24).
In infectious diseases, we are currently evaluating two candidates, IMC-M113V and IMC-I109V, in Phase 1 clinical trials for a potential functional cure in human immunodeficiency virus ("HIV") and hepatitis B virus ("HBV"), respectively.
Brenetafusp, a PRAME-targeted candidate, is being evaluated in an ongoing Phase 3 registrational trial, PRISM-MEL-301, in first-line advanced cutaneous melanoma, after we randomized the first patient in the second quarter of 2024, and we are enrolling patients in multiple expansion arms of the Phase 1/2 clinical trial.