Licensing and Collaborations - Tharimmune entered into a patent license agreement with Avior Inc. on November 3, 2023, receiving exclusive rights to develop and commercialize TH104 and TH103, with an upfront license fee in the mid-six digits and additional milestone payments totaling $24.25 million[96][102]. - Tharimmune's strategy includes pursuing collaborations to maximize the value of its pipeline and bring novel therapies to patients with high unmet needs[102]. - The ABSI Agreement includes quarterly payments of $50,000 starting March 18, 2024, for research services related to the development of ABSI Products targeting HER2 and HER3[101]. Clinical Development - The FDA approved the IND application for TH104 in February 2023, targeting moderate-to-severe chronic pruritis in patients with primary biliary cholangitis, where over 70% of patients suffer from debilitating itching[96]. - Tharimmune is advancing TH3215, a bispecific antibody targeting HER2 and HER3, into IND-enabling studies expected in 2025, alongside TH0059 and TH1940, which are also anticipated to enter IND-enabling studies in the same year[97]. - The company completed a Phase 1 clinical trial for TH104, with 19 out of 20 participants completing the study, demonstrating a comparable safety profile to the FDA-approved nalmefene[103]. Financial Performance - Tharimmune has not recognized any revenue for the three months ended March 31, 2024, and 2023[104]. - Total operating expenses decreased by $367,095, or approximately 13.5%, to $2,347,303 for the three months ended March 31, 2024, compared to $2,714,398 for the same period in 2023[116]. - Research and development expenses decreased by $22,419, or 2%, to $1,025,258 for the three months ended March 31, 2024, from $1,047,677 for the same period in 2023[117]. - General and administrative expenses decreased by $344,676, or 21%, to $1,322,045 for the three months ended March 31, 2024, from $1,666,721 for the same period in 2023[118]. - Interest expense decreased by $1,438, or 23%, to $4,700 for the three months ended March 31, 2024, from $6,138 for the same period in 2023[119]. - Interest income increased by $63,646, or 197%, to $95,894 for the three months ended March 31, 2024, from $32,248 for the same period in 2023[120]. - Net loss improved by $432,179, or approximately 16.1%, to $2,256,109 for the three months ended March 31, 2024, compared to $2,688,288 for the same period in 2023[116]. - Cash used in operating activities decreased by $639,509, or approximately 18.4%, to $2,825,181 for the three months ended March 31, 2024, from $3,464,690 for the same period in 2023[126]. - Cash provided by financing activities decreased by $206,245, or approximately 39.3%, to $317,119 for the three months ended March 31, 2024, from $523,364 for the same period in 2023[126]. - The accumulated deficit as of March 31, 2024, was approximately $27.0 million[122]. - The company anticipates needing substantial additional funding to support future operating activities due to recurring negative cash flows[123]. Research and Development Expenses - Research and development expenses are expected to increase as Tharimmune plans to commence clinical trials for TH3215 and TH1940, following the deprioritization of HSB-1216[107]. - General and administrative expenses are projected to rise as the company increases personnel to support ongoing research and development activities[112]. - The company issued 25,107 shares of common stock valued at $9.95 per share as part of the ABSI Agreement, totaling $250,000 in compensation expense[101].
Tharimmune(THAR) - 2024 Q1 - Quarterly Report