Licensing and Agreements - Tharimmune entered into a patent license agreement with Avior Inc. for TH104 and TH103, receiving an exclusive sublicensable right and license, with an upfront fee of $400,000 and potential milestone payments totaling $24.25 million[386][392]. - The company licensed INT-023/TH023, an oral anti-TNF-α monoclonal antibody, from Intract Pharma, with an upfront fee of $400,000 and mid-single digit royalties based on net product sales[387][394]. - A Research and Development Collaboration Agreement with Applied Biomedical Science Institute was established, granting exclusive rights to ABSI Patents, with a total compensation expense of $250,000 for stock issued[390][391]. - The Enkefalos License Agreement was signed for global rights to cyclotide compounds for HER2 antibodies, with an upfront fee of $150,000 and potential milestone payments up to $8.5 million[393]. - An at-the-market offering agreement was entered into with Rodman & Renshaw LLC, allowing the sale of common stock up to a total amount of $1.65 million[395]. Clinical Development - The FDA approved the IND application for TH104 in February 2023, targeting moderate-to-severe chronic pruritus in patients with primary biliary cholangitis, with topline data expected in Q4 2025[386]. - The Phase 1 clinical trial of TH104 showed an absolute bioavailability (F) of 45.9% compared to intravenous nalmefene, with a median time to maximum concentration (Cmax) of 2.0 hours and a mean half-life (T1/2) of 14 hours[396]. - The FDA provided positive feedback for the Phase 2 clinical trial of TH104, confirming the plan to pursue a 505(b)(2) approval pathway[397]. - The company plans to initiate a hepatic impairment study prior to launching the Phase 2 study for TH104 in early 2025[397]. - Tharimmune is developing a pipeline of novel therapeutic candidates targeting high-value immuno-oncology targets, including bispecific antibodies and antibody drug conjugates, with IND-enabling studies anticipated in 2025[388]. - The company has a strategy to develop HS0059 as a bispecific ADC targeting HER2 and HER3 receptors in high unmet need tumors[389]. Financial Performance - Research and development expenses increased by $2.8 million, or 80%, to $6.4 million for the year ended December 31, 2024, primarily due to clinical trial expenses and increased license fees[415]. - Total operating expenses for the year ended December 31, 2024, were $12.4 million, an increase of $2.98 million compared to $9.46 million in 2023[414]. - The company incurred a net loss of $12.2 million for the year ended December 31, 2024, compared to a net loss of $9.3 million in 2023[414]. - Interest income increased by $97,277, or 64%, to $249,908 for the year ended December 31, 2024, primarily due to increased cash from PIPE offerings[418]. - Net cash used in operating activities for 2024 was $10.9 million, an increase of 49% from $7.3 million in 2023[424][425][426]. - Net cash provided by financing activities decreased to $3.5 million in 2024 from $11.7 million in 2023, a decline of approximately 70%[424][428]. - The net loss for 2024 was $12.2 million, compared to a net loss of $9.3 million in 2023, representing a 31% increase in losses[425][426]. - Cash decrease for 2024 was $7.4 million, contrasting with an increase of $4.4 million in 2023[424]. - Non-cash stock-based compensation for 2024 was approximately $0.7 million, slightly down from $0.8 million in 2023[425][426]. - Proceeds from PIPE offerings in 2024 amounted to $4.1 million, contributing to the financing activities[427]. Company Strategy and Future Outlook - The company has an accumulated deficit of approximately $36.9 million as of December 31, 2024, and will need substantial additional funding to support future operations[420]. - The company plans to continue relying on exemptions under the JOBS Act as an "emerging growth company" until certain revenue or debt thresholds are met[438]. - The company utilizes estimates in financial reporting, which may lead to variances between estimated and actual results[430]. - Research and development costs are expensed as incurred, with significant investments in clinical trials and drug supply manufacturing[431]. - The company executed a reverse stock split at a ratio of 1-for-15 on May 24, 2024[429].
Tharimmune(THAR) - 2024 Q4 - Annual Report