Core Insights - Tharimmune, Inc. has received positive feedback from the FDA regarding its lead clinical asset, TH104, which is a nalmefene buccal film aimed at mitigating respiratory depression caused by potent opioids [1][3][5] Regulatory Developments - The FDA concurred with Tharimmune's pharmacokinetic simulation modeling plan, which is essential for advancing TH104 as a prophylactic treatment [3] - The FDA's feedback is expected to de-risk the TH104 program and aligns with the company's strategy for a 505(b)(2) New Drug Application (NDA) submission [3][5] Operational Milestones - Tharimmune is set to initiate a comprehensive Chemistry, Manufacturing, and Controls (CMC) plan, which is crucial for scaling production and ensuring the quality of TH104 [4] - The company has previously conducted a positive pharmacokinetic simulation analysis for TH104, reinforcing its potential as a superior treatment option for military personnel and first responders [5] Product Advantages - TH104 is designed for non-injectable, rapid absorption and self-administration, making it advantageous for first responders in high-risk environments [5] - The simulation analysis indicated that TH104 could achieve protective concentration levels within approximately 30 minutes post-dose and maintain protection for about 24 hours, which is a significant improvement over existing options like naloxone [7]

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].

Core Insights - Tharimmune, Inc. has successfully closed a private placement, raising approximately $545 million to support its strategy involving the Canton Network and Canton Coin [1][2][3] Company Overview - Tharimmune is the first publicly traded company to leverage Canton Coin to enhance the Canton Network's capabilities in digitizing traditional financial markets [1][13] - The company plans to operate as a Super Validator and run additional Validators on the Canton Network, utilizing the net proceeds for these initiatives [2][4] Investment and Participation - The private placement was led by DRW and Liberty City Ventures, with participation from notable investors such as ARK Invest, Kraken, and Goldman Sachs, among others [3][4] - The Canton Foundation, which oversees the Canton Network, also supported Tharimmune, marking it as the only publicly traded company backed by the foundation [3] Strategic Direction - Tharimmune aims to implement a differentiated digital asset treasury strategy, focusing on acquiring Canton Coin and investing in applications that enhance institutional utility and adoption [4][5] - The company has appointed Mark Wendland as CEO and Mark Toomey as President to lead this strategy, while maintaining its existing management for clinical-stage biotechnology operations [5] Market Context - The Canton Network is designed to facilitate privacy-preserving and interoperable applications across global capital markets, already processing over 500,000 daily transactions as of September 30, 2025 [6][7] - This growth indicates a rising demand for tokenization frameworks that align with institutional requirements for blockchain adoption [7]

Core Insights - Tharimmune has raised approximately $540 million in a private placement to pivot towards a digital asset treasury strategy centered on canton coin [1][2] - The company's stock increased by about 30% following the announcement, while the value of canton coin decreased by 4% [1] Funding and Participation - The funding round included participation from various crypto-native and traditional finance entities such as ARK Invest, Kraken, and the Canton Foundation, marking Tharimmune as the first publicly traded company supported by the Foundation [2] - Clear Street served as the sole placement agent and financial advisor for the offering [5] Use of Proceeds - The proceeds from the funding will be utilized for acquiring canton coin, covering operational costs, and establishing multiple validator nodes on the Canton Network to earn CC rewards [3] Canton Network Overview - The Canton Network, supported by major financial institutions like Goldman Sachs and BNP Paribas, aims to integrate traditional financial infrastructure through interoperable smart contracts and processes over 500,000 daily transactions [4] - Tharimmune's biotech operations will continue under the existing team, with Mark Wendland appointed as CEO to lead the treasury initiative and Mark Toomey as president [4]

Core Viewpoint - Tharimmune, Inc. has announced a private placement offering to raise approximately $540 million through the sale of common stock at a price of $3.075 per share, aimed at acquiring Canton Coin and supporting its digital asset treasury strategy [1][3][4]. Group 1: Offering Details - The private placement is expected to close around November 6, 2025, pending customary closing conditions [3]. - The offering involves participation from notable investors including ARK Invest, Bitwave, and the Canton Foundation, which oversees the Canton Network [2][6]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to acquire Canton Coin, a utility token for the Canton Network, and for general corporate purposes [3][4]. - Tharimmune plans to operate as a Super Validator on the Canton Network to generate additional CC tokens [3][4]. Group 3: Strategic Vision - Tharimmune believes that the Canton Network's blockchain technology is transforming financial infrastructure by enhancing programmability, privacy, and interoperability [4][5]. - The company aims to implement a diverse strategy that includes CC acquisition and the development of applications on the Canton Network to drive institutional utility and scalability [4][5]. Group 4: Management and Leadership - Mark Wendland has been appointed as CEO to oversee the digital asset treasury strategy, while Mark Toomey will serve as President [8]. - Both leaders bring extensive experience in operational leadership and global financial markets [8][9]. Group 5: Market Context - The Canton Network is noted for its ability to connect trusted institutions on a secure blockchain, with significant assets and support from major financial players [5]. - As of September 30, 2025, the Canton Network recorded over 500,000 daily transactions, showcasing its scalability [9].

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - AgriFORCE Growing Systems Ltd. (AGRI) has increased by 263% to $8.73 [3] - Qualigen Therapeutics, Inc. (QLGN) has risen by 212% to $8.87 [3] - Flora Growth Corp. (FLGC) is up 103% at $55.36 [3] - Boxlight Corporation (BOXL) has gained 102% to $3.16 [3] - Platinum Analytics Cayman Limited (PLTS) is up 96% at $14.00 [3] - Metsera, Inc. (MTSR) has increased by 59% to $52.99 [3] - Anywhere Real Estate Inc. (HOUS) is up 51% at $10.72 [3] - Fold Holdings, Inc. (FLD) has risen by 30% to $5.93 [3] - ARB IOT Group Limited (ARBB) is up 28% at $8.02 [3] - MBX Biosciences, Inc. (MBX) has increased by 26% to $12.64 [3] Premarket Losers - AlphaVest Acquisition Corp (ATMV) has decreased by 27% to $15.99 [4] - Helius Medical Technologies, Inc. (HSDT) is down 17% at $20.00 [4] - CEA Industries Inc. (BNC) has fallen by 15% to $8.20 [4] - Simpple Ltd. (SPPL) is down 13% at $5.00 [4] - FatPipe, Inc. (FATN) has decreased by 11% to $7.87 [4] - Tharimmune, Inc. (THAR) is down 11% at $3.20 [4] - Yueda Digital Holding (YDKG) has fallen by 11% to $2.98 [4] - American Battery Technology Company (ABAT) is down 10% at $2.94 [4] - AGM Group Holdings Inc. (AGMH) has decreased by 9% to $9.36 [4] - Antelope Enterprise Holdings Limited (AEHL) is down 5% at $3.38 [4]

Core Insights - Tharimmune, Inc. is a clinical-stage biotechnology company focused on developing innovative therapeutic candidates for inflammation, immunology, and critical unmet medical needs [1][4] - The company will participate in three major Fall conferences to present new results, including the ACG Annual Scientific Meeting, AASLD Annual Conference, and AAPS PharmSci 360 [2][3] Company Overview - Tharimmune's lead clinical asset, TH104, targets respiratory and/or nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids [4] - The expanded pipeline includes indications for chronic pruritus in primary biliary cholangitis and TH023, which addresses autoimmune diseases [4] - The company utilizes proprietary EpiClick Technology for a multispecific biologic platform targeting solid tumors and has a license agreement with OmniAb, Inc. for antibody discovery technology [4]

Part I [Financial Statements](index=5&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) The company's unaudited condensed consolidated financial statements for the period ended June 30, 2025, reflect a $4.4 million net loss for the first six months, decreased cash and total assets, a significant accumulated deficit, and recent financing activities, highlighting substantial doubt about its going concern ability [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $2.53 million from $3.72 million, driven by reduced cash, while total liabilities slightly decreased and stockholders' equity significantly fell from $1.31 million to $0.37 million Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,241,980 | $3,559,361 | | Total current assets | $2,530,166 | $3,721,624 | | **Total assets** | **$2,530,166** | **$3,721,624** | | **Liabilities & Equity** | | | | Total current liabilities | $2,162,807 | $2,413,982 | | **Total liabilities** | **$2,162,807** | **$2,413,982** | | Accumulated deficit | $(41,297,951) | $(36,901,094) | | **Total stockholders' equity** | **$367,359** | **$1,307,642** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three and six months ended June 30, 2025, net losses were $1.86 million and $4.40 million respectively, narrowing from 2024 primarily due to reduced research and development expenses Statement of Operations Summary (Unaudited) | Metric | Q2 2025 ($) | Q2 2024 ($) | H1 2025 ($) | H1 2024 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $546,204 | $999,553 | $1,140,274 | $2,024,811 | | General and administrative | $1,304,956 | $1,373,901 | $3,257,555 | $2,695,946 | | **Loss from operations** | **$(1,851,160)** | **$(2,373,454)** | **$(4,397,829)** | **$(4,720,757)** | | **Net loss** | **$(1,855,153)** | **$(2,325,057)** | **$(4,396,857)** | **$(4,581,166)** | | **Net loss per share (Basic & Diluted)** | **$(0.64)** | **$(2.42)** | **$(1.61)** | **$(4.96)** | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operations improved to $3.83 million, financing activities provided $2.51 million, resulting in a $1.32 million cash decrease and an ending balance of $2.24 million Cash Flow Summary for the Six Months Ended June 30 (Unaudited) | Cash Flow Activity | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,831,531) | $(5,004,484) | | Net cash provided by financing activities | $2,514,150 | $1,964,959 | | **Net decrease in cash** | **$(1,317,381)** | **$(3,039,525)** | | **Cash, end of period** | **$2,241,980** | **$7,895,827** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's clinical-stage biotech business, product pipeline, accounting policies, a going concern warning due to recurring losses, recent equity financings, stock-based compensation, and commitments, with subsequent events including additional post-quarter financing - The company is a clinical-stage biotechnology firm focused on immunology and inflammation, with its lead candidate, **TH104**, receiving positive FDA feedback for a 505(b)(2) New Drug Application (NDA) pathway for an indication related to opioid exposure, expected to be the lead program[26](index=26&type=chunk) - Management has concluded there is **substantial doubt** about the Company's ability to continue as a going concern for at least one year, citing recurring negative cash flows and the need for substantial additional funding[31](index=31&type=chunk) - The company has actively raised capital through an At-the-Market (ATM) agreement and multiple Private Investment in Public Equity (PIPE) offerings in June 2024, December 2024, and June 2025, raising combined net proceeds of approximately **$5.9 million**[30](index=30&type=chunk) - Subsequent to the quarter end, the company closed a registered direct offering for **$1.74 million** in July 2025 and another private placement for approximately **$1.1 million** in net proceeds[117](index=117&type=chunk)[118](index=118&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=28&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses the company's clinical-stage candidates, noting a decreased net loss in Q2 and H1 2025 due to lower R&D, while the liquidity section reiterates going concern uncertainty and reliance on equity financing [Overview](index=28&type=section&id=Overview) Tharimmune is a clinical-stage biotech focused on immunology and inflammation, primarily developing TH104 for opioid exposure prophylaxis via a 505(b)(2) NDA pathway, alongside TH023 and an early-stage immuno-oncology pipeline - The lead program is **TH104**, focusing on the PrHPO indication (prophylaxis of respiratory/nervous system depression from high-potency opioids) following positive FDA feedback on a 505(b)(2) NDA pathway[123](index=123&type=chunk) - The company licensed **TH023**, an oral anti-TNF-α monoclonal antibody (infliximab), from Intract Pharma and plans to advance it through regulatory authorization for a first-in-human trial[124](index=124&type=chunk)[127](index=127&type=chunk) - The company is also developing an early-stage immuno-oncology pipeline, including bispecific antibodies like **HS1940** (anti-PD-1/VEGF) and **HS3215** (anti-HER2/HER3)[125](index=125&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) The company's net loss decreased in both Q2 and H1 2025 compared to prior year, primarily due to lower research and development expenses, while general and administrative expenses increased over the six-month period Comparison of Results for the Three Months Ended June 30, | Expense Category | 2025 ($) | 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research and development | $546,204 | $999,553 | $(453,349) | | General and administrative | $1,304,956 | $1,373,901 | $(68,945) | | **Net loss** | **$(1,855,153)** | **$(2,325,057)** | **$469,904** | - The Q2 2025 decrease in R&D expenses was mainly due to lower pre-clinical vendor expenses (approximately **$0.3 million**) and license fees (approximately **$0.4 million**), offset by higher stock-based compensation (approximately **$0.2 million**)[148](index=148&type=chunk) Comparison of Results for the Six Months Ended June 30, | Expense Category | 2025 ($) | 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research and development | $1,140,274 | $2,024,811 | $(884,537) | | General and administrative | $3,257,555 | $2,695,946 | $561,609 | | **Net loss** | **$(4,396,857)** | **$(4,581,166)** | **$184,309** | - The H1 2025 increase in G&A expenses was primarily due to increases in stock compensation expense (approximately **$0.3 million**), investor relations fees (approximately **$0.5 million**), and director remuneration (approximately **$0.2 million**), offset by lower personnel expense (approximately **$0.4 million**)[154](index=154&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The company finances operations through equity offerings, faces substantial doubt about its going concern ability due to a $41.3 million accumulated deficit and recurring losses, necessitating significant additional capital - The company had an accumulated deficit of approximately **$41.3 million** as of June 30, 2025, and incurred operating losses of **$4.4 million** in the first six months of 2025[158](index=158&type=chunk) - Recent financing includes combined net proceeds of approximately **$5.9 million** from PIPE offerings in June 2024, December 2024, and June 2025, and **$0.2 million** from ATM sales in April and May 2025[159](index=159&type=chunk)[160](index=160&type=chunk) - There is **substantial doubt** about the company's ability to continue as a going concern, and failure to obtain sufficient additional funding could force delays or termination of clinical trial activities[161](index=161&type=chunk)[162](index=162&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a "smaller reporting company," Tharimmune, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The Company is a "smaller reporting company" as defined in Rule 12b-2 of the Exchange Act and is not required to provide the information for this item[179](index=179&type=chunk) [Controls and Procedures](index=39&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2025[180](index=180&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[181](index=181&type=chunk) Part II [Legal Proceedings](index=39&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is not currently aware of any legal proceedings or claims that would materially adversely affect its business, financial condition, or operating results - The company is currently not aware of any legal proceedings or claims that will have, individually or in the aggregate, a material adverse effect on its business[184](index=184&type=chunk) [Risk Factors](index=39&type=section&id=ITEM%201A.%20RISK%20FACTORS) No material changes have occurred in the company's risk factors from those previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024 - There have been **no material changes** in the company's risk factors from those previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024[185](index=185&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) The company reported no unregistered sales of equity securities during the period - None[186](index=186&type=chunk) [Other Information](index=40&type=section&id=ITEM%205.%20OTHER%20INFORMATION) During the quarter ended June 30, 2025, no directors or executive officers adopted or terminated any Rule 10b5-1 trading plan or non-Rule 10b5-1 trading arrangement - During the fiscal quarter ended June 30, 2025, none of the Company's directors or executive officers adopted or terminated any contract, instruction, or written plan for the purchase or sale of Company securities intended to satisfy the affirmative defense conditions of Rule 10b5-1(c)[189](index=189&type=chunk) [Exhibits](index=40&type=section&id=ITEM%206.%20EXHIBITS) This section lists exhibits filed with the Form 10-Q, including warrant agreements, employment agreements, securities purchase agreements, and required officer certifications - The report includes several exhibits, such as warrant agreements from a recent offering, employment agreements for the CEO and Chairman, and a settlement agreement with the former CEO[189](index=189&type=chunk)

TH104 - Opioid Overdose Prophylaxis - TH104 is a first-in-class buccal film delivery of nalmefene for military use and is NDA fileable[6, 84] - The FDA has confirmed that no additional clinical trials will be required prior to NDA submission for TH104 for its initial indication[7] - Current naloxone autoinjector provides approximately 2-hour protection versus 7-hour fentanyl exposure, necessitating frequent re-dosing[17] - Government acquired 788,000 Kaléo autoinjector units, indicating growing demand for synthetic opioid countermeasures[46] - At 24-hours, Groups A & B in Phase 1 Chronic Liver Disease (CLD) Study had mean declines of 30.7% & 35.2%, respectively in pruritus scores[106] TH023 - Oral Anti-TNFα for Autoimmune Diseases - TH023 is an oral anti-TNFα monoclonal antibody targeting autoimmune diseases and is Phase 1-ready[6, 84] - The oral anti-TNFα market opportunity has the potential to disrupt the $50B+ global autoimmune biologics market[6, 84] - The existing market size generated annually by TNFα inhibitors (e.g., Humira, Remicade) is approximately $47B[58] Strategic & Financial - The company anticipates a clear pathway to NDA submission for TH104 within 12 months of CMC initiation[34] - The global PBC treatment market is valued at approximately $2.5B and is expected to grow[96]

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]