Tharimmune(THAR) - 2025 Q1 - Quarterly Report

Licensing and Collaborations - Tharimmune entered into a patent license agreement with Avior Inc. on November 3, 2023, paying an upfront license fee of $0.4 million and a quarterly fee of $0.15 million for 2024[107][114] - Tharimmune licensed INT-023/TH023, an oral anti-TNF-α monoclonal antibody, from Intract Pharma Limited, receiving a mid-six digit upfront payment and potential mid-single digit royalties based on net sales[108][116] - The Avior agreement includes milestone payments totaling $24.25 million upon achieving various development milestones[114] - The company aims to pursue strategic collaborations and potential mergers to enhance the value of its pipeline[112] Product Development - The FDA approved an 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[107] - The company plans to develop TH104 as a buccal film product for both chronic pruritus and temporary prophylaxis of respiratory depression in military personnel[112] - Tharimmune anticipates advancing HS3215, a HER2/HER3 bispecific antibody, into preclinical studies in 2025[110] - The company received positive FDA feedback on a regulatory pathway for TH104's additional indication for opioid exposure prophylaxis, requiring only nonclinical studies before NDA submission[107] - Tharimmune's strategy includes a capital-efficient approach to meet FDA requirements for filing an NDA for TH104[107] - The company plans to delay the Phase 2 trial of TH104 in chronic pruritus patients until after completing a hepatic impairment study, following positive FDA feedback[121] Financial Performance - The company incurred a net loss of $2,541,704 for the three months ended March 31, 2025, compared to a net loss of $2,256,109 for the same period in 2024[134] - Net cash used in operating activities was $2,689,001 for the three months ended March 31, 2025, compared to $2,825,181 for the same period in 2024[144] - Research and development expenses decreased by $431,188, or 42%, to $594,070 for the three months ended March 31, 2025, primarily due to reduced clinical trial expenses[135] - General and administrative expenses increased by $630,554, or 43%, to $1,952,599 for the three months ended March 31, 2025, driven by higher investor relations and corporate tax expenses[136] - Interest expense rose by $3,771, or 80%, to $8,471 for the three months ended March 31, 2025, mainly due to insurance premium financing liabilities[137] - Interest income decreased by $82,458, or 86%, to $13,436 for the three months ended March 31, 2025, attributed to a decline in cash reserves[138] - The accumulated deficit was approximately $39.4 million as of March 31, 2025, indicating ongoing financial challenges[139] - The company raised gross proceeds of $0.26 million in April 2025 from the sale of 160,817 shares at an average price of $1.61 per share[140] Accounting and Reporting - Management estimates for financial statements are based on historical experience and reasonable assumptions, affecting reported amounts of assets, liabilities, revenue, and expenses[151] - Research and development costs are expensed as incurred, including personnel costs and third-party contractor expenses, with accruals based on estimates of services performed[152] - Stock-based compensation costs are measured at grant date using the Black-Scholes model, with fair value amortized over the requisite service period[154] - The expected term of stock options granted ranges from five to seven years, with risk-free interest rates based on the U.S. Treasury yield curve[155] - The company has chosen to take advantage of extended transition periods under the JOBS Act for complying with new accounting standards, which may affect comparability with other public companies[158] - As an "emerging growth company," the company intends to rely on certain exemptions, including not providing an auditor's attestation report on internal controls until certain conditions are met[159] - The company is classified as a "smaller reporting company" and is not required to provide specific market risk disclosures[160] Clinical Trial Results - 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[120]