Tharimmune(THAR) - 2025 Q3 - Quarterly Report

Licensing and Development - Tharimmune entered into a patent license agreement with Avior Inc. for exclusive rights to develop and commercialize TH104 and TH103, with TH104 targeting chronic pruritus and potential military applications [143]. - The FDA approved an IND application for TH104 in February 2023, with plans to file a 505(b)(2) NDA for TH104's use in temporary prophylaxis against opioid exposure [143]. - Tharimmune licensed INT-023/TH023, an oral anti-TNF-α monoclonal antibody, from Intract Pharma, expanding its therapeutic pipeline [144]. - The company is developing HS1940, a bispecific biologic targeting PD-1 and VEGF, and has completed initial pre-clinical testing for HS3215, a HER2/HER3 bispecific antibody [145]. - Tharimmune plans to conduct additional nonclinical studies for TH104, with no additional clinical trials required prior to NDA submission for the PrHPO indication [143]. Financial Performance - Tharimmune did not recognize any revenue for the three and nine months ended September 30, 2025 and 2024 [163]. - Research and development expenses decreased by approximately $2.0 million, or 88%, to approximately $0.3 million for the three months ended September 30, 2025, from approximately $2.3 million for the same period in 2024 [175]. - General and administrative expenses increased by $0.2 million, or 15%, to $1.8 million for the three months ended September 30, 2025, from $1.6 million for the same period in 2024 [176]. - Net loss for the three months ended September 30, 2025, was $2.1 million, a decrease of $1.7 million compared to a net loss of $3.8 million for the same period in 2024 [174]. - Total operating expenses for the nine months ended September 30, 2025, were $6.5 million, a decrease of $2.1 million compared to $8.6 million for the same period in 2024 [179]. - Interest income decreased by approximately $205,000, or 92%, to $16,992 for the nine months ended September 30, 2025, from $222,236 for the same period in 2024 [184]. - The company incurred operating losses of approximately $6.5 million during the nine months ended September 30, 2025, with an accumulated deficit of approximately $43.4 million as of the same date [185]. - Cash used in operating activities for the nine months ended September 30, 2025, was $5.7 million, compared to $7.9 million for the same period in 2024 [193]. - Interest expense increased by approximately $11,000, or 89%, to $24,280 for the nine months ended September 30, 2025, from $12,926 for the same period in 2024 [182]. - The company may need substantial additional funding to support future operating activities due to recurring negative cash flows [189]. - Cash provided by financing activities for the nine months ended September 30, 2025 was $9.7 million, a significant increase from $1.7 million in the same period of 2024 [196][197]. - The net increase in financing activities in 2025 was driven by gross proceeds from PIPE Offerings totaling $3.7 million and Direct Offerings totaling $7.1 million [196]. Stock and Accounting Practices - The company executed a reverse stock split at a ratio of 1-for-15 on May 24, 2024, retroactively adjusting all share amounts in the financial statements [198]. - Research and development costs are expensed as incurred, including personnel costs and third-party contractor expenses [200]. - Stock-based compensation costs are recognized over the requisite service period based on the estimated fair value of the awards [202]. - The fair value of stock options is estimated using the Black-Scholes option-pricing model, with expected terms between five and seven years [203]. - The company is utilizing the extended transition periods under the JOBS Act for complying with new accounting standards, which may affect comparability with other public companies [206]. - The company is classified as an "emerging growth company" and intends to rely on certain exemptions provided by the JOBS Act [207]. - The company is not required to provide market risk disclosures as it qualifies as a "smaller reporting company" under the Exchange Act [208]. Funding and Capital Management - The company raised approximately $99.4 million through a private placement offering of 25,966,048 shares at $3.075 per share [153]. - In a separate offering, Tharimmune raised approximately $446.2 million through the sale of pre-funded warrants for 145,105,094 shares, with proceeds in Canton Coin [154]. - The company adopted a digital asset treasury strategy involving the Canton Network to enhance capital efficiency and diversify treasury management practices [161].