Licensing and Agreements - Tharimmune entered into a patent license agreement with Avior Inc. for exclusive rights to develop TH104 and TH103, with an upfront payment in the mid-six digits and milestone payments totaling $24.25 million[114][121] - The company licensed INT-023/TH023, an oral anti-TNF-α monoclonal antibody, from Intract Pharma, with a mid-six digit upfront payment and mid-single digit royalties based on net product sales[115][123] - A manufacturing agreement for clinical trial supply of TH104 was signed, with clinical packaging expected by the end of the year[126] - The Enkefalos License Agreement involves an upfront payment of $150,000 and milestone payments up to $8.5 million[122] - The company entered into a nonbinding letter of intent to acquire Intract, with Intract shareholders expected to own 49% of the combined entity, Tharimmune, Inc.[127] Research and Development - TH104 is being developed for the treatment of moderate-to-severe chronic pruritis in patients with primary biliary cholangitis, with topline data expected in Q4 2025[114] - The company is advancing TH3215, a bispecific antibody targeting HER2 and HER3, into IND-enabling studies in 2025[116] - TH0059, a HER2/HER3 bispecific ADC, and TH1940, a PD-1 Picobody, are also expected to enter IND-enabling studies in 2025[116] - Research and development expenses increased by $1.8 million, or 367%, to $2.3 million for the three months ended September 30, 2024, primarily due to clinical trial expenses and license fees[137] - For the nine months ended September 30, 2024, research and development expenses increased by $1.7 million, or 68%, to $4.3 million, mainly due to clinical trial expenses and license fees[141] - Research and development costs are expensed as incurred, including personnel costs and third-party contractor expenses[158] Financial Performance - The company incurred operating losses of approximately $8.6 million for the nine months ended September 30, 2024, with an accumulated deficit of approximately $33.1 million[145] - Cash used in operating activities for the nine months ended September 30, 2024 was $7.9 million, consisting of a net loss of $8.4 million[151] - Interest income rose by $44,277, or 156%, to $72,728 for the three months ended September 30, 2024, attributed to increased cash from recent offerings[140] - General and administrative expenses increased by $0.2 million, or 17%, to $1.6 million for the three months ended September 30, 2024, driven by personnel costs and professional fees[138] - The company expects general and administrative expenses to increase in the future as it expands personnel to support research activities[134] Funding and Capital Structure - A securities purchase agreement was signed for a private placement, resulting in net proceeds of approximately $1.8 million[125] - The company has financed its working capital primarily through the issuance of common stock, raising approximately $13.6 million in gross proceeds from public offerings in 2023[145] - Cash provided by financing activities for the nine months ended September 30, 2024 was $1.7 million, a decrease from $2.1 million in the same period of 2023[153][154] - The net increase in financing activities for 2024 was due to proceeds from the PIPE Offering of $2.1 million and insurance premium financing liability of $0.4 million[153] - The company executed a reverse stock split at a ratio of 1-for-15 on May 24, 2024, retroactively adjusting all issued and outstanding common stock amounts[155] Compliance and Accounting - The company has chosen to take advantage of the extended transition periods under the JOBS Act for complying with new accounting standards[164] - The company is classified as an "emerging growth company" and intends to rely on certain exemptions provided by the JOBS Act[166] - The fair value of stock options is estimated using the Black-Scholes option-pricing model, with expected terms between five and seven years[161] - Stock-based compensation costs are recognized over the requisite service period based on the estimated fair value of the awards[160] - The company is not required to provide market risk disclosures as it is classified as a "smaller reporting company"[167] Going Concern - The company faces substantial doubt about its ability to continue as a going concern for at least one year due to recurring negative cash flows and the need for additional funding[146]
Tharimmune(THAR) - 2024 Q3 - Quarterly Report