Clinical validation for targeting CD19 in lupus has recently been achieved via several sets of impressive data from third parties utilizing CD19-directed CAR-T, where patients achieved what effectively appears to be complete resolution of disease markers and symptoms. We believe that the safety, tolerability, and any potential durability challenges with CAR-T therapy could favor an antibody-based approach like TNT119, which has the potential to be better tolerated and more conveniently administered. Specifically, safety concerns like cytokine release syndrome and neurotoxicity have occurred in patients receiving CD19-directed CAR-T. We believe an antibody approach like TNT119 has the potential to access and deplete tissue-level B-cell niches that are the main drivers of disease, potentially providing similar levels of B-cell depletion and efficacy as CAR-T, but with an overall differentiated target product profile.
With the completion of the acquisition and the concurrent financing, we believe that we are well-positioned to transition Eliem into a leading immunology and inflammation company. Our projected 3-year timeline for TNT119 development has several key milestones and catalysts. In 2024, our goal is to open and initiate two Phase 2 clinical trials, one in lupus and one in immune thrombocytopenia. By the end of 2024, we expect to have finalized our high concentration formulation to potentially support subcutaneous dosing of TNT119. We’re also targeting publishing a more comprehensive set of our membranous nephropathy data at a medical conference in the 4th quarter of this year. Importantly, we expect to have a strong financial position and cash runway after the closing of the acquisition and the private placement that we expect will fund our current plans into 2027 and enable key clinical readouts for TNT119.
While we have a focused set of initial lead indications that we’re really excited about, we also want to highlight our belief that there is immense opportunity for TNT119 in other autoimmune diseases. Across both orphan and larger indications, more than 2.5 million patients in the US are living with an autoantibody-mediated disease. There are several areas of high unmet need, and we plan to intelligently progress and expand the addressable patient population with TNT119.
We believe there are additional opportunities to expand the pipeline, either via additional indications for TNT119, such as Myasthenia Gravis, or external business development to add on complimentary programs in the immunology and inflammation space. Following closing of the acquisition and financing, we expect to have a strong financial position that will provide us with the flexibility to act upon additional BD interests and continue to evolve the company as a leader in immunology and inflammation.
pg. 7