Tharimmune(THAR) - 2025 Q2 - Quarterly Report

Part I Financial Statements 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 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 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 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 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] - 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] - 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] - 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 $1.1 million in net proceeds[117][118] Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A) Management discusses the company's clinical-stage candidates, noting a decreased net loss in Q2 and H1 2025 due to lower R&D, while the liquidity section reiterates going concern uncertainty and reliance on equity financing Overview Tharimmune is a clinical-stage biotech focused on immunology and inflammation, primarily developing TH104 for opioid exposure prophylaxis via a 505(b)(2) NDA pathway, alongside TH023 and an early-stage immuno-oncology pipeline - The lead program is TH104, focusing on the PrHPO indication (prophylaxis of respiratory/nervous system depression from high-potency opioids) following positive FDA feedback on a 505(b)(2) NDA pathway[123] - The company licensed TH023, an oral anti-TNF-α monoclonal antibody (infliximab), from Intract Pharma and plans to advance it through regulatory authorization for a first-in-human trial[124][127] - The company is also developing an early-stage immuno-oncology pipeline, including bispecific antibodies like HS1940 (anti-PD-1/VEGF) and HS3215 (anti-HER2/HER3)[125] Results of Operations The company's net loss decreased in both Q2 and H1 2025 compared to prior year, primarily due to lower research and development expenses, while general and administrative expenses increased over the six-month period Comparison of Results for the Three Months Ended June 30, | Expense Category | 2025 ($) | 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 $0.2 million)[148] Comparison of Results for the Six Months Ended June 30, | Expense Category | 2025 ($) | 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] Liquidity and Capital Resources 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] - 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][160] - 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][162] Quantitative and Qualitative Disclosures About Market Risk 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] Controls and Procedures 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] - 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] Part II Legal Proceedings 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] Risk Factors 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] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the period - None[186] Other Information 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] Exhibits 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]