[10-Q] Tharimmune, Inc. Quarterly Earnings Report
Tharimmune, Inc. is a clinical-stage biotech focused on immunology and inflammation programs, including TH104 (buccal film) and oral infliximab programs licensed from Avior and Intract. The company received FDA IND approval for TH104 in February 2023 and reported positive FDA feedback in March 2025 on a Pre-IND request for a prophylactic high-potency opioid indication (PrHPO), where the FDA indicated a 505(b)(2) NDA pathway is feasible with additional nonclinical in vitro toxicology but no new clinical trials expected to define the prophylactic dosing window.
Financially, Tharimmune had $2.24 million in cash and
Tharimmune, Inc. è una biotech in fase clinica focalizzata su programmi di immunologia e infiammazione, tra cui TH104 (film buccale) e programmi di infliximab orale concessi in licenza da Avior e Intract. La società ha ottenuto l'approvazione IND dalla FDA per TH104 nel febbraio 2023 e ha riferito un riscontro positivo dalla FDA a marzo 2025 su una richiesta Pre-IND per un'indicazione profilattica con oppioidi ad alta potenza (PrHPO), nella quale la FDA ha indicato che una via NDA 505(b)(2) è percorribile previo ulteriori studi tossicologici non clinici in vitro, ma non sono previsti nuovi studi clinici per definire la finestra di dosaggio profilattica.
Sul piano finanziario, Tharimmune disponeva di $2.24 million in cash e di $2.53 million total assets al 30 giugno 2025; ha riportato una perdita netta di $4.40 million per i sei mesi chiusi il 30 giugno 2025, ha utilizzato $3.83 million di cassa operativa nello stesso periodo e presentava un deficit accumulato di $41.3 million. La società ha raccolto proventi da finanziamenti PIPE e ATM (proventi netti combinati di circa $5.9 million fino al 30 giugno 2025 e un PIPE di giugno 2025 netto di circa $2.3 million), ma ha segnalato un dubbio sostanziale sulla sua capacità di continuare come azienda in funzionamento per almeno un anno.
Tharimmune, Inc. es una biotecnológica en fase clínica centrada en programas de inmunología e inflamación, que incluyen TH104 (película bucal) y programas de infliximab oral licenciados por Avior e Intract. La compañía obtuvo la aprobación IND de la FDA para TH104 en febrero de 2023 y comunicó un comentario positivo de la FDA en marzo de 2025 sobre una solicitud Pre-IND para una indicación profiláctica de opioides de alta potencia (PrHPO), en la que la FDA indicó que una vía NDA 505(b)(2) es factible con estudios toxicológicos no clínicos in vitro adicionales, pero no se esperan nuevos ensayos clínicos para definir la ventana de dosificación profiláctica.
En lo financiero, Tharimmune tenía $2.24 million in cash y $2.53 million total assets al 30 de junio de 2025; reportó una pérdida neta de $4.40 million en los seis meses terminados el 30 de junio de 2025, utilizó $3.83 million de efectivo operativo en el mismo periodo y mantenía un déficit acumulado de $41.3 million. La compañía recaudó fondos mediante financiaciones PIPE y ATM (ingresos netos combinados de aproximadamente $5.9 million hasta el 30 de junio de 2025 y un PIPE de junio de 2025 neto de ~$2.3 million), pero declaró que existía una duda sustancial sobre su capacidad para continuar como empresa en funcionamiento durante al menos un año.
Tharimmune, Inc.는 면역학 및 염증 관련 프로그램에 주력하는 임상 단계의 바이오텍으로, TH104(협부 필름)과 Avior 및 Intract로부터 도입한 경구형 인플릭시맙 프로그램을 포함합니다. 회사는 2023년 2월 TH104에 대한 FDA IND 승인을 받았고, 2025년 3월 예방적 고효능 오피오이드 적응증(PrHPO)에 관한 Pre-IND 요청에 대해 FDA로부터 긍정적인 피드백을 받았으며, FDA는 추가적인 비임상 체외 독성 시험을 전제로 505(b)(2) NDA 경로가 가능하다고 밝혔지만 예방적 투여 범위를 규정하기 위한 새로운 임상시험은 필요하지 않다고 했습니다.
재무적으로 Tharimmune는 2025년 6월 30일 기준 $2.24 million의 현금과 $2.53 million의 총자산을 보유했고, 2025년 6월 30일로 끝나는 6개월 동안 $4.40 million의 순손실을 보고했으며 같은 기간에 $3.83 million의 영업활동 현금을 사용했고 누적 적자는 $41.3 million입니다. 회사는 PIPE 및 ATM 자금조달로 자금을 조달(2025년 6월 30일까지 합산 순수익 약 $5.9 million, 2025년 6월 PIPE 순수익 약 $2.3 million)했으나 향후 1년 이상 기업 지속성에 대해 중대한 의문을 표명했습니다.
Tharimmune, Inc. est une biotech en phase clinique spécialisée dans des programmes d'immunologie et d'inflammation, notamment TH104 (film buccal) et des programmes d'infliximab oral sous licence d'Avior et Intract. La société a obtenu l'approbation IND de la FDA pour TH104 en février 2023 et a annoncé un retour positif de la FDA en mars 2025 sur une demande Pre‑IND pour une indication prophylactique d'opioïdes à haute puissance (PrHPO). La FDA a indiqué qu'une voie NDA 505(b)(2) était envisageable sous réserve d'études toxicologiques in vitro non cliniques supplémentaires, mais aucun nouvel essai clinique n'était attendu pour définir la fenêtre posologique prophylactique.
Sur le plan financier, Tharimmune disposait au 30 juin 2025 de 2,24 millions de dollars en liquidités et de 2,53 millions de dollars d'actifs totaux, a enregistré une perte nette de 4,40 millions de dollars pour les six mois clos le 30 juin 2025, a utilisé 3,83 millions de dollars de trésorerie d'exploitation au cours de la même période et présentait un déficit accumulé de 41,3 millions de dollars. La société a levé des fonds via des financements PIPE et ATM (produits nets combinés d'environ 5,9 millions de dollars jusqu'au 30 juin 2025 et un PIPE de juin 2025 net d'environ 2,3 millions de dollars), mais a fait état d'un doute substantiel quant à sa capacité à poursuivre son activité pendant au moins un an.
Tharimmune, Inc. ist ein Biotech-Unternehmen in klinischer Phase mit Schwerpunkt auf Programmen zur Immunologie und Entzündung, darunter TH104 (bukkaler Film) und orale Infliximab‑Programme, die von Avior und Intract lizenziert wurden. Das Unternehmen erhielt im Februar 2023 die FDA‑IND‑Zulassung für TH104 und berichtete im März 2025 über positives Feedback der FDA zu einer Pre‑IND‑Anfrage für eine prophylaktische Indikation mit hochpotenten Opioiden (PrHPO). Die FDA erklärte, dass ein 505(b)(2)‑NDA‑Weg mit zusätzlicher nichtklinischer in vitro‑Toxikologie möglich sei, jedoch keine neuen klinischen Studien zur Festlegung des prophylaktischen Dosierungsfensters erwartet würden.
Finanziell verfügte Tharimmune zum 30. Juni 2025 über $2.24 million an liquiden Mitteln und $2.53 million an Gesamtvermögen, meldete einen Nettoverlust von $4.40 million für die sechs Monate zum 30. Juni 2025, verwendete im selben Zeitraum $3.83 million an operativem Cash und wies einen kumulierten Fehlbetrag von $41.3 million auf. Das Unternehmen erzielte Erlöse aus PIPE‑ und ATM‑Finanzierungen (kombinierte Nettoerlöse von etwa $5.9 million bis zum 30. Juni 2025 und ein PIPE im Juni 2025 netto von ~$2.3 million), gab jedoch erhebliche Zweifel an seiner Fähigkeit zur Unternehmensfortführung für mindestens ein Jahr an.
- FDA gave positive Pre-IND feedback for TH104 PrHPO, indicating a potential 505(b)(2) NDA pathway without additional clinical trials to define prophylactic dosing.
- Completed multiple financings including a June 2025 PIPE and ATM sales, yielding combined net proceeds of approximately $5.9 million through June 30, 2025 to fund operations.
- Exclusive licenses obtained for TH104/TH103 (Avior) and oral infliximab program (Intract), providing rights to develop multiple product candidates and delivery platforms.
- Substantial doubt about going concern—management concluded prevailing conditions raise substantial doubt about ability to continue for at least one year.
- Low liquidity: cash and cash equivalents of $2,241,980 at June 30, 2025 versus $3,559,361 at December 31, 2024.
- Persistent operating losses: net loss of $4,396,857 for the six months ended June 30, 2025 and accumulated deficit of $41.3 million.
- Declining stockholders' equity: total equity decreased to $367,359 at June 30, 2025 from $1,307,642 at December 31, 2024.
Insights
TL;DR: Weak liquidity and recurring losses create material near-term financing risk.
Tharimmune's balance sheet shows limited cash of $2.24 million and negative operating cash flow of $3.83 million for H1 2025, while net losses remain similar year-over-year ($4.40M vs $4.58M). Equity raises (PIPE/ATM) provided relief, but stockholders' equity fell to $367k. Management's disclosure of substantial doubt is warranted and indicates the company will need further capital to execute CMC work and NDA preparations for TH104. For investors, the primary financial risk is funding the next 12 months without dilutive financings on potentially unfavorable terms.
TL;DR: FDA feedback on TH104 PrHPO is a meaningful regulatory positive for an accelerated NDA path.
The Company states the FDA provided positive feedback on a Pre-IND for TH104's prophylactic use against high-potency opioids, indicating a 505(b)(2) NDA pathway and that additional in vitro nonclinical studies are needed but no additional clinical trials to define the prophylactic dosing window. This reduces clinical development time and cost risk for the PrHPO indication and positions TH104 as a nearer-term filing opportunity versus the PBC pruritus indication. However, CMC and nonclinical requirements remain to be completed to support NDA submission.
Tharimmune, Inc. è una biotech in fase clinica focalizzata su programmi di immunologia e infiammazione, tra cui TH104 (film buccale) e programmi di infliximab orale concessi in licenza da Avior e Intract. La società ha ottenuto l'approvazione IND dalla FDA per TH104 nel febbraio 2023 e ha riferito un riscontro positivo dalla FDA a marzo 2025 su una richiesta Pre-IND per un'indicazione profilattica con oppioidi ad alta potenza (PrHPO), nella quale la FDA ha indicato che una via NDA 505(b)(2) è percorribile previo ulteriori studi tossicologici non clinici in vitro, ma non sono previsti nuovi studi clinici per definire la finestra di dosaggio profilattica.
Sul piano finanziario, Tharimmune disponeva di $2.24 million in cash e di $2.53 million total assets al 30 giugno 2025; ha riportato una perdita netta di $4.40 million per i sei mesi chiusi il 30 giugno 2025, ha utilizzato $3.83 million di cassa operativa nello stesso periodo e presentava un deficit accumulato di $41.3 million. La società ha raccolto proventi da finanziamenti PIPE e ATM (proventi netti combinati di circa $5.9 million fino al 30 giugno 2025 e un PIPE di giugno 2025 netto di circa $2.3 million), ma ha segnalato un dubbio sostanziale sulla sua capacità di continuare come azienda in funzionamento per almeno un anno.
Tharimmune, Inc. es una biotecnológica en fase clínica centrada en programas de inmunología e inflamación, que incluyen TH104 (película bucal) y programas de infliximab oral licenciados por Avior e Intract. La compañía obtuvo la aprobación IND de la FDA para TH104 en febrero de 2023 y comunicó un comentario positivo de la FDA en marzo de 2025 sobre una solicitud Pre-IND para una indicación profiláctica de opioides de alta potencia (PrHPO), en la que la FDA indicó que una vía NDA 505(b)(2) es factible con estudios toxicológicos no clínicos in vitro adicionales, pero no se esperan nuevos ensayos clínicos para definir la ventana de dosificación profiláctica.
En lo financiero, Tharimmune tenía $2.24 million in cash y $2.53 million total assets al 30 de junio de 2025; reportó una pérdida neta de $4.40 million en los seis meses terminados el 30 de junio de 2025, utilizó $3.83 million de efectivo operativo en el mismo periodo y mantenía un déficit acumulado de $41.3 million. La compañía recaudó fondos mediante financiaciones PIPE y ATM (ingresos netos combinados de aproximadamente $5.9 million hasta el 30 de junio de 2025 y un PIPE de junio de 2025 neto de ~$2.3 million), pero declaró que existía una duda sustancial sobre su capacidad para continuar como empresa en funcionamiento durante al menos un año.
Tharimmune, Inc.는 면역학 및 염증 관련 프로그램에 주력하는 임상 단계의 바이오텍으로, TH104(협부 필름)과 Avior 및 Intract로부터 도입한 경구형 인플릭시맙 프로그램을 포함합니다. 회사는 2023년 2월 TH104에 대한 FDA IND 승인을 받았고, 2025년 3월 예방적 고효능 오피오이드 적응증(PrHPO)에 관한 Pre-IND 요청에 대해 FDA로부터 긍정적인 피드백을 받았으며, FDA는 추가적인 비임상 체외 독성 시험을 전제로 505(b)(2) NDA 경로가 가능하다고 밝혔지만 예방적 투여 범위를 규정하기 위한 새로운 임상시험은 필요하지 않다고 했습니다.
재무적으로 Tharimmune는 2025년 6월 30일 기준 $2.24 million의 현금과 $2.53 million의 총자산을 보유했고, 2025년 6월 30일로 끝나는 6개월 동안 $4.40 million의 순손실을 보고했으며 같은 기간에 $3.83 million의 영업활동 현금을 사용했고 누적 적자는 $41.3 million입니다. 회사는 PIPE 및 ATM 자금조달로 자금을 조달(2025년 6월 30일까지 합산 순수익 약 $5.9 million, 2025년 6월 PIPE 순수익 약 $2.3 million)했으나 향후 1년 이상 기업 지속성에 대해 중대한 의문을 표명했습니다.
Tharimmune, Inc. est une biotech en phase clinique spécialisée dans des programmes d'immunologie et d'inflammation, notamment TH104 (film buccal) et des programmes d'infliximab oral sous licence d'Avior et Intract. La société a obtenu l'approbation IND de la FDA pour TH104 en février 2023 et a annoncé un retour positif de la FDA en mars 2025 sur une demande Pre‑IND pour une indication prophylactique d'opioïdes à haute puissance (PrHPO). La FDA a indiqué qu'une voie NDA 505(b)(2) était envisageable sous réserve d'études toxicologiques in vitro non cliniques supplémentaires, mais aucun nouvel essai clinique n'était attendu pour définir la fenêtre posologique prophylactique.
Sur le plan financier, Tharimmune disposait au 30 juin 2025 de 2,24 millions de dollars en liquidités et de 2,53 millions de dollars d'actifs totaux, a enregistré une perte nette de 4,40 millions de dollars pour les six mois clos le 30 juin 2025, a utilisé 3,83 millions de dollars de trésorerie d'exploitation au cours de la même période et présentait un déficit accumulé de 41,3 millions de dollars. La société a levé des fonds via des financements PIPE et ATM (produits nets combinés d'environ 5,9 millions de dollars jusqu'au 30 juin 2025 et un PIPE de juin 2025 net d'environ 2,3 millions de dollars), mais a fait état d'un doute substantiel quant à sa capacité à poursuivre son activité pendant au moins un an.
Tharimmune, Inc. ist ein Biotech-Unternehmen in klinischer Phase mit Schwerpunkt auf Programmen zur Immunologie und Entzündung, darunter TH104 (bukkaler Film) und orale Infliximab‑Programme, die von Avior und Intract lizenziert wurden. Das Unternehmen erhielt im Februar 2023 die FDA‑IND‑Zulassung für TH104 und berichtete im März 2025 über positives Feedback der FDA zu einer Pre‑IND‑Anfrage für eine prophylaktische Indikation mit hochpotenten Opioiden (PrHPO). Die FDA erklärte, dass ein 505(b)(2)‑NDA‑Weg mit zusätzlicher nichtklinischer in vitro‑Toxikologie möglich sei, jedoch keine neuen klinischen Studien zur Festlegung des prophylaktischen Dosierungsfensters erwartet würden.
Finanziell verfügte Tharimmune zum 30. Juni 2025 über $2.24 million an liquiden Mitteln und $2.53 million an Gesamtvermögen, meldete einen Nettoverlust von $4.40 million für die sechs Monate zum 30. Juni 2025, verwendete im selben Zeitraum $3.83 million an operativem Cash und wies einen kumulierten Fehlbetrag von $41.3 million auf. Das Unternehmen erzielte Erlöse aus PIPE‑ und ATM‑Finanzierungen (kombinierte Nettoerlöse von etwa $5.9 million bis zum 30. Juni 2025 und ein PIPE im Juni 2025 netto von ~$2.3 million), gab jedoch erhebliche Zweifel an seiner Fähigkeit zur Unternehmensfortführung für mindestens ein Jahr an.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For
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TABLE OF CONTENTS
| Page No. | ||
| PART I – FINANCIAL INFORMATION | ||
| ITEM 1. | FINANCIAL STATEMENTS | |
| Condensed Consolidated Balance Sheets as of June 30, 2025 (Unaudited) and December 31, 2024 | F-1 | |
| Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited) | F-2 | |
| Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited) | F-3 | |
| Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024 (Unaudited) | F-4 | |
| Notes to Condensed Consolidated Financial Statements | F-5 | |
| ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 4 |
| ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 12 |
| ITEM 4. | CONTROLS AND PROCEDURES | 13 |
| PART II – OTHER INFORMATION | 13 | |
| ITEM 1. | LEGAL PROCEEDINGS | 13 |
| ITEM 1A. | RISK FACTORS | 13 |
| ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS | 13 |
| ITEM 3. | DEFAULTS UPON SENIOR SECURITIES | 14 |
| ITEM 5. | OTHER INFORMATION | 14 |
| ITEM 6. | EXHIBITS | 14 |
| SIGNATURES | 15 | |
| 2 |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:
| ● | our projected financial position and estimated cash burn rate; | |
| ● | our estimates regarding expenses, future revenues and capital requirements; | |
| ● | our ability to continue as a going concern; | |
| ● | our need to raise substantial additional capital to fund our operation; | |
| ● | the success, cost and timing of our clinical trials; | |
| ● | our dependence on third parties in the conduct of our clinical trials; | |
| ● | our ability to obtain the necessary regulatory approvals to market and commercialize our product candidates; | |
| ● | the impact of a health epidemic on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; | |
| ● | the potential that results of pre-clinical and clinical trials indicate our current product candidates or any future product candidates we may seek to develop are unsafe or ineffective; | |
| ● | the results of market research conducted by us or others; | |
| ● | our ability to obtain and maintain intellectual property protection for our current and future product candidates; | |
| ● | our ability to protect our intellectual property rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our intellectual property rights; | |
| ● | the possibility that a third party may claim we or our third-party licensors have infringed, misappropriated or otherwise violated their intellectual property rights and that we may incur substantial costs and be required to devote substantial time defending against claims against us; | |
| ● | our reliance on third-party suppliers and manufacturers; | |
| ● | the success of competing therapies and products that are or become available; | |
| ● | our ability to expand our organization to accommodate potential growth and our ability to retain and attract key personnel; | |
| ● | the potential for us to incur substantial costs resulting from product liability lawsuits against us and the potential for these product liability lawsuits to cause us to limit our commercialization of our product candidates; | |
| ● | market acceptance of our product candidates, the size and growth of the potential markets for our current product candidates and any future product candidates we may seek to develop, and our ability to serve those markets; | |
| ● | the successful development of our commercialization capabilities, including sales and marketing capabilities; and | |
| ● | general business and economic conditions, such as inflationary pressures, geopolitical conditions and other trade barriers. |
All of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form 10-Q, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q.
This Quarterly Report on Form 10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company surveys, market research, consultant surveys, publicly available information, reports of governmental agencies and industry publications, articles and surveys. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. While we believe that such studies and publications are reliable, we have not independently verified market and industry data from third-party sources.
| 3 |
THARIMMUNE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2025 | December 31, 2024 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Prepaid expenses and other current assets | ||||||||
| Deferred offering costs | ||||||||
| Total current assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Insurance premium financing liability | - | |||||||
| Note payable | - | |||||||
| Total current liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (see Note 5) | - | |||||||
| Stockholders’ equity | ||||||||
| Preferred stock, $ | - | - | ||||||
| Common stock, $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Treasury stock, at cost, | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| F-1 |
THARIMMUNE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest income | ||||||||||||||||
| Total other income (expense), net | ( | ) | ||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average number of common shares outstanding*: | ||||||||||||||||
| Basic and diluted | ||||||||||||||||
| * |
The accompanying notes are an integral part of these condensed consolidated financial statements.
| F-2 |
THARIMMUNE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2025 AND 2024 (UNAUDITED)
| Shares | Amount | Capital | Deficit | Shares | Amount | Total | ||||||||||||||||||||||
| Additional | ||||||||||||||||||||||||||||
| Common Stock | Paid-in | Accumulated | Treasury Stock | |||||||||||||||||||||||||
| Shares | Amount | Capital | Deficit | Shares | Amount | Total | ||||||||||||||||||||||
| For the three months ended June 30, 2024: | ||||||||||||||||||||||||||||
| Balance, March 31, 2024* | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Private investment in public equity offering, net of issuance costs of $ | - | - | - | |||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | - | - | ( | ) | |||||||||||||||||||
| Stock based compensation | - | - | - | - | - | |||||||||||||||||||||||
| Balance, June 30, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| For the six months ended June 30, 2024: | ||||||||||||||||||||||||||||
| Balance, December 31, 2023* | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Stock issuance pursuant to services agreement | - | - | - | |||||||||||||||||||||||||
| Private investment in public equity offering, net of issuance costs of $ | - | - | - | |||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | - | - | ( | ) | |||||||||||||||||||
| Stock based compensation | - | - | - | - | - | |||||||||||||||||||||||
| Balance, June 30, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| For the three months ended June 30, 2025: | ||||||||||||||||||||||||||||
| Balance, March 31, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||
| Private investment in public equity offering, net of issuance costs of $ | - | - | - | |||||||||||||||||||||||||
| At-the-market offerings, net of issuance costs | - | - | - | |||||||||||||||||||||||||
| Cashless exercise of pre-funded warrants | ( | ) | - | - | - | - | ||||||||||||||||||||||
| Issuance costs related to Form S-8 Options Registration Statement | - | - | ( | ) | - | - | - | ( | ) | |||||||||||||||||||
| Stock issuance pursuant to termination agreement | - | - | - | |||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | - | - | ( | ) | |||||||||||||||||||
| Stock based compensation | - | - | - | - | - | |||||||||||||||||||||||
| Balance, June 30, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| For the six months ended June 30, 2025: | ||||||||||||||||||||||||||||
| Balance, December 31, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Balance | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Private investment in public equity offering, net of issuance costs of $ | - | - | - | |||||||||||||||||||||||||
| Private investment in public equity offering, net of issuance costs | - | - | - | |||||||||||||||||||||||||
| At-the-market offerings, net of issuance costs | - | - | - | |||||||||||||||||||||||||
| Cashless exercise of pre-funded warrants | ( | ) | - | - | - | - | ||||||||||||||||||||||
| Stock issuance pursuant to bonus liability | - | - | - | - | - | |||||||||||||||||||||||
| Restricted stock unit issuance pursuant to service agreement | ( | ) | - | - | - | - | ||||||||||||||||||||||
| Issuance costs related to Form S-8 Options Registration Statement | - | - | ( | ) | - | - | - | ( | ) | |||||||||||||||||||
| Stock issuance pursuant to termination agreement | - | - | - | |||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | - | - | ( | ) | |||||||||||||||||||
| Stock based compensation | - | - | - | - | - | |||||||||||||||||||||||
| Balance, June 30, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| Balance | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||
| * |
The accompanying notes are an integral part of these condensed consolidated financial statements.
| F-3 |
THARIMMUNE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
| 2025 | 2024 | |||||||
| For the Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock based compensation | ||||||||
| Stock issuance pursuant to termination agreement | - | |||||||
| Stock issuance pursuant to services agreement | - | |||||||
| Increase in operating assets: | ||||||||
| Prepaid expenses and other current assets | ( | ) | ( | ) | ||||
| Increase (decrease) in operating liabilities: | ||||||||
| Accounts payable | ( | ) | ( | ) | ||||
| Accrued expenses | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Net cash provided by (used in) investing activities | - | - | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of common stock upon private investment in public equity offering | ||||||||
| Proceeds from issuance of common stock upon at-the-market offerings | - | |||||||
| Payment of deferred offering costs | ( | ) | ( | ) | ||||
| Proceeds from insurance premium financing liability | ||||||||
| Repayment of insurance premium financing liability | ( | ) | ( | ) | ||||
| Repayment of note payable | ( | ) | - | |||||
| Net cash provided by financing activities | ||||||||
| Net decrease in cash | ( | ) | ( | ) | ||||
| Cash, beginning of period | ||||||||
| Cash, end of period | $ | $ | ||||||
| Supplemental disclosure of non-cash financing activities: | ||||||||
| Unpaid deferred financing costs | $ | - | $ | |||||
| Amortization of deferred offering costs from ATM offering | $ | $ | - | |||||
| Reduction of premium related to insurance premium financing | $ | $ | - | |||||
| Issuance of note payable for settlement of previously incurred professional fees | $ | $ | - | |||||
| Issuance of options to settle liability | $ | $ | - | |||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| F-4 |
THARIMMUNE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note 1 – Description of Business and Liquidity
Nature of Operations
Tharimmune, Inc. (formerly, Hillstream BioPharma, Inc.) (“Tharimmune” or the “Company”) was incorporated on March 28, 2017, as a Delaware C-corporation. At June 30, 2025, Tharimmune had one wholly-owned subsidiary: Hillstream Oncology, Inc. (“Hillstream Oncology”), formerly, HB Pharma Corp.
Tharimmune is a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation conditions with high unmet need. On November 3, 2023, the Company entered into a patent license agreement (the “Avior License Agreement”) with Avior Inc. d/b/a Avior Bio, LLC (“Avior”) pursuant to which it received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize TH104 and TH103) and to practice the Licensed Technology in connection with the foregoing, throughout the world (each as defined in the Avior License Agreement). In February 2023, the U.S. Food and Drug Administration (“FDA”) approved an investigational new drug (“IND”) application for TH104. TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritus or “uncontrollable itching.” With respect to TH104, the Company originally intended to first seek approval for the treatment of moderate to severe chronic pruritus in patients with primary biliary cholangitis (“PBC”), an orphan rare form of liver disease with no known cure in which more than 70% of patients suffer from debilitating chronic pruritic. The Company engaged and received positive feedback in March 2025 from the FDA regarding the additional proposed indication of temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids (“PrHPO”), for which it submitted a Pre-Investigational New Drug Application (“PIND”). With respect to the PIND for this additional proposed indication for TH104, the Company received positive feedback from the FDA regarding a regulatory pathway that will allow it to submit a 505(b)(2) New Drug Application (“NDA”) for TH104. The FDA advised that the Company will need to perform additional nonclinical studies (i.e., in vitro toxicology studies), but the FDA confirmed that it does not believe any additional clinical trials will be required to define the prophylactic dosing window prior to IND or NDA submission for this indication, which the Company expects will be the lead program. The Company intends to pursue the pruritus in PBC indication subsequent to the nearer term opportunity of filing an NDA for PrHPO. the Company intends to conduct a capital efficient strategy to file an NDA for PrHPO, which involves actively progressing its Chemistry, Manufacturing, and Controls (“CMC”) plan to meet the stringent requirements for filing an NDA with the FDA. This comprehensive plan encompasses all aspects of the manufacturing process, quality control measures, and product stability to ensure the consistent production of a high-quality buccal film formulation known as TH104.
On September 11, 2024, Tharimmune entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited (“Intract”), pursuant to which, the Company exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab. Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor TNF-α. Under the terms of the Intract Agreement, the Company licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program.
The Company has developed an early-stage pipeline of novel therapeutic candidates targeting validated high value immuno-oncology (“IO”) targets including human epidermal growth factor (“EGF”) receptor 2 (“HER2”), human EGF receptor 3 (“HER3”) and programmed cell death protein 1 (“PD-1”). The Company is developing antibodies including bispecific antibodies and small molecular weight bovine-derived “knob” domains which have the potential to target and bind more tightly to “undruggable” epitopes differently than full sized antibodies. The Company is advancing HS1940, a bispecific biologic against both PD-1 and vascular endothelial growth receptor (“VEGF”) antibody which targets both receptors. We have also developed HS3215, a bispecific antibody against both HER2 and HER3 which targets a novel “bridging epitope” encompassing multiple domains of the HER2 extracellular domain (“ECD”) as well as ligand-dependent and independent blocking of the ECD of HER3.
In addition, on May 23, 2024, HB Pharma Corp. filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary of State of the State of Delaware pursuant to which it changed its name to Hillstream Oncology, Inc. effective as of May 23, 2024.
| F-5 |
Liquidity and Going Concern
The
accompanying condensed consolidated financial statements have been prepared on the basis that the Company will continue as a going concern,
which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. During
the six months ended June 30, 2025, the Company incurred operating losses in the amount of approximately $
Based on the Company’s limited operating history, recurring negative cash flows from operations, current plans and available resources, the Company will need substantial additional funding to support future operating activities. The Company has concluded that the prevailing conditions and ongoing liquidity risks faced raise substantial doubt about the Company’s ability to continue as a going concern for at least one year following the date these condensed consolidated financial statements are issued. The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary should the Company be unable to continue as a going concern.
The Company may seek to raise additional funding through the sale of additional equity or debt securities, enter into strategic partnerships, grants, or other arrangements or a combination of the foregoing to support its future operations; however, there can be no assurance that the Company will be able to obtain additional capital on terms acceptable to the Company, on a timely basis or at all. The failure to obtain sufficient additional funding could adversely affect the Company’s ability to achieve its business objectives and product development timelines and may result in the Company delaying or terminating clinical trial activities which could have a material adverse effect on the Company’s results of operations.
Other Risks and Uncertainties
There can be no assurance that the Company’s products, if approved, will be accepted in the marketplace, nor can there be any assurance that any future products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics, or that such products will be successfully marketed, if at all. The Company is subject to risks common to biopharmaceutical and biotechnology companies including, but not limited to, the development of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, product liability, uncertainty of market acceptance of products and the need to obtain additional financing. The Company is dependent on third party suppliers. The Company’s products require approval or clearance from the FDA prior to commencing commercial sales in the United States. Approvals or clearances are also required in foreign jurisdictions in which the Company may license or sell its products. There can be no assurance that the Company’s products will receive all of the required approvals or clearances.
| F-6 |
Note 2 – Summary of Significant Accounting Policies
Basis of Presentation
These accompanying unaudited condensed consolidated interim financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. These condensed consolidated financial statements are unaudited and, in the opinion of management, include all adjustments (consisting of normal recurring adjustments and accruals) necessary for a fair statement of the balance sheet, operating results, and cash flows for the periods presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Operating results for the six months ended June 30, 2025 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2025 or any other future period. Certain information and footnote disclosure normally included in the annual financial statements prepared in accordance with U.S. GAAP have been omitted in accordance with the SEC’s rules and regulations for interim reporting. The Company’s financial position, results of operations, and cash flows are presented in U.S. Dollars. These condensed consolidated financial statements and related notes should be read in conjunction with the audited financial statements and related notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 26, 2025.
The Company operates in one segment and the Company’s Chief Executive Officer serves as the chief operating decision maker (“CODM”). The CODM uses net loss, as reported in the condensed consolidated financial statements, to monitor budget versus actual results and allocate resources. The CODM is regularly provided with financial information, including expenses, in a format consistent with the condensed consolidated statements of operations. The CODM does not review assets at a different level than those disclosed in the consolidated balance sheet.
Reverse Stock Splits
On
May 24, 2024, the Company effectuated a reverse split of shares of its common stock at a ratio of
Principles of Consolidation
The condensed consolidated financial statements include the accounts of Tharimmune and its wholly-owned subsidiary, Hillstream Oncology. All significant intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Areas of the condensed consolidated financial statements where estimates may have the most significant effect include research and development expense recognition, valuation of common shares and share-based compensation, allowances of deferred tax assets, valuation of debt related instruments, and cash flow assumptions regarding going concern considerations. Although management believes the estimates that have been used are reasonable, actual results could vary from the estimates that were used.
Concentration of Credit Risk
The
Company maintains cash balances with various financial institutions. Account balances at these institutions are insured by the Federal
Deposit Insurance Corporation (“FDIC”) up to $
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash equivalents, if any, are stated at cost and consist primarily of money market accounts.
| F-7 |
Research and Development
Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including third-party contractors to perform research, conduct clinical trials, and manufacture drug supplies and materials. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by third parties, patient enrollment in clinical trials, administrative costs incurred by third parties, and other indicators of the services completed.
Stock-Based Compensation
The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees, and directors as an expense in the condensed consolidated statements of operations over the requisite service period based on a measurement of fair value for each stock-based award. The fair value of common stock issued pursuant to termination agreements as well as restricted stock or restricted stock units is generally measured as the grant-date price of the Company’s common stock. The fair value of each option grant to employees, non-employees, and directors is estimated as of the date of grant using the Black-Scholes option-pricing model, net of actual forfeitures. The fair value is amortized as compensation cost on the straight-line basis over the requisite service period of the awards, which is generally the vesting period.
Prior to January 12, 2022, the Company was a private company and the Company’s common stock has only been publicly traded since that date. As a result, the Company has limited company-specific historical and implied volatility information. Therefore, it has estimated its expected stock volatility based on the historical data of a publicly traded set of peer companies. The expected term of stock options granted was between five and seven years. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve in effect at the time of grant for time periods approximately equal to the expected term of the award.
Fair Value Measurements
The Company applies Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”), which establishes a framework for measuring fair value and clarifies the definition of fair value within that framework. ASC 820 defines fair value as an exit price, which is the price that would be received for an asset or paid to transfer a liability in the Company’s principal or most advantageous market in an orderly transaction between market participants on the measurement date. The fair value hierarchy established in ASC 820 generally requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based on market data and the entity’s judgments about the assumptions that market participants would use in pricing the asset or liability and are to be developed based on the best information available in the circumstances.
The carrying value of the Company’s cash, prepaid expenses, accounts payable, and accrued expenses approximate fair value because of the short-term maturity of these financial instruments.
The valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input that is significant to the fair value measurement. The levels within the valuation hierarchy are described below:
| Level 1 Inputs: Observable inputs such as quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. | |
| Level 2 Inputs: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for assets or liabilities recently traded in active markets, with similar underlying terms, as well as direct or indirect observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals, as well as quoted prices for identical or similar assets or liabilities in markets that are not active. |
| Level 3 Inputs: Unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for the assets or liabilities, that reflect the reporting entity’s own assumptions. |
| F-8 |
Deferred Offering Costs
Deferred
offering costs consists primarily of legal, accounting, underwriters’ fees, printing, and filing fees that are incurred prior to
an offering of the Company’s common stock and are initially capitalized and then subsequently reclassified to additional paid-in
capital upon completion of the offering. If an offering is not completed, any associated offering costs will be expensed immediately
upon termination of the offering. At June 30, 2025 and December 31, 2024, there were $
Insurance Premium Financing Liability
In
January 2024, the Company entered into an insurance premium financing agreement for $
In
January 2025, the Company entered into an insurance premium financing agreement for $
Retirement Plan
The
Company has a 401(k) defined contribution plan which covers all employees that meet the plan’s eligibility requirements. Eligible
employees may contribute a percentage of their salary subject to certain limitations. The Company makes a discretionary match which is
currently equal to 3% of employee contributions. Total company contributions to the plan were $
Income Taxes
The Company accounts for income taxes using the asset-and-liability method in accordance with FASB ASC Topic 740, Income Taxes (“ASC 740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.
Deferred income taxes are recognized for the tax effect of temporary differences between the financial statement carrying amount of assets and liabilities and the amounts used for income tax purposes and for certain changes in valuation allowances. Valuation allowances are recorded to reduce certain deferred tax assets when, in management’s estimation, it is more-likely-than-not that a tax benefit will not be realized. A full valuation allowance has been recognized for all periods since it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized in future periods.
The Company follows the guidance in FASB ASC Subtopic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions and clarifies the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement. The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical merits. The second step involves measurement of the amount to be recognized. Tax positions that meet the more-likely-than-not threshold are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the taxing authority. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that the position is more-likely-than-not to be sustained by the relevant taxing authority. The Company will recognize interest and penalties related to tax positions in income tax expense. At June 30, 2025 and December 31, 2024, the Company had no unrecognized uncertain income tax positions, and therefore no amounts have been recognized in the condensed consolidated financial statements.
| F-9 |
Net Loss per Share
The Company reports loss per share in accordance with FASB ASC Subtopic 260-10, Earnings Per Share, which provides for calculation of basic and diluted earnings per share. Basic earnings per share includes no dilution and is computed by dividing net income or loss available to common stockholders by the weighted average common shares outstanding for the period. Diluted earnings per share reflect the potential dilution of securities that could share in the earnings of an entity. The calculation of diluted net earnings (loss) per share gives effect to common stock equivalents; however, potential common shares are excluded if their effect is anti-dilutive.
Potentially
dilutive securities not included in the computation of loss per share for the six months ended June 30, 2025 and 2024 included options
to purchase
Recently Adopted Accounting Pronouncements
The Company has evaluated all recent accounting pronouncements that were required to be adopted or are required to be adopted in the near future and believes that none of them will have a material effect on the Company’s financial position, results of operations, or cash flows.
Note 3 – Note Payable
The
Company issued a promissory note in the amount of $
As
the promissory note does not have an interest component, imputed interest at
Note 4 – Common Stock
Pursuant
to the Company’s Certificate of Incorporation, the Company has
| F-10 |
On
January 24, 2024, pursuant to a corporate advisory consulting agreement, the Company issued
On
June 7, 2024, the Company entered into the ATM Agreement with Rodman & Renshaw LLC (the “ATM Sales Manager”) under which
the Company may sell, from time to time through the ATM Sales Manager, shares of common stock in one or more offerings up to a total
dollar amount of $
On
June 21, 2024, the Company closed a private placement offering with certain accredited investors of $
On
December 9, 2024, the Company closed an additional private placement offering with certain accredited investors of $
On
December 20, 2024, the Company sold
During
the six months ended June 30, 2025, the Company sold
| F-11 |
On
June 13, 2025, the Company closed an additional private placement offering with certain accredited investors of $
Note 5 – Stock Based Compensation
Incentive Plans and Options
Under
the Company’s 2017 Stock Incentive Plan (the “2017 Plan”), the Company could grant incentive stock options, non-statutory
stock options, rights to purchase common stock, stock appreciation rights, restricted stock, performance shares, and performance units
to employees, directors, and consultants of the Company and its affiliates. Up to
The
Company granted options to acquire
In
July 2019, the Company authorized an additional plan, the 2019 Stock Incentive Plan (the “2019 Plan”). Under the 2019 Plan,
the Company could grant incentive stock options, non-statutory stock options, rights to purchase common stock, stock appreciation rights,
restricted stock, performance shares, and performance units to employees, directors, and consultants of the Company and its affiliates.
At both June 30, 2025 and December 31, 2024, a total of
As
of both June 30, 2025 and December 31, 2024, the Company has granted options to acquire
On
August 17, 2023, the Company authorized the Tharimmune, Inc. 2023 Omnibus Incentive Plan (as amended, the “2023 Plan”). Under
the 2023 Plan, the Company may grant incentive stock options, non-statutory stock options, rights to purchase common stock, stock appreciation
rights, restricted stock, performance shares, and performance units to employees, directors, and consultants of the Company and its affiliates.
Initially, there were
| F-12 |
During
the three and six months ended June 30, 2025, the Company granted
The following table summarizes stock-based activities under the 2017 Plan, 2019 Plan, and 2023 Stock Incentive Plans:
Schedule of Stock Option Activity
| Weighted | Weighted | |||||||||||
| Shares | Average | Average | ||||||||||
| Underlying | Exercise | Contractual | ||||||||||
| Options | Price | Terms | ||||||||||
| Outstanding at December 31, 2024 | $ | |||||||||||
| Granted | $ | |||||||||||
| Forfeited | ( | ) | $ | |||||||||
| Outstanding at June 30, 2025 | $ | |||||||||||
| Exercisable options at June 30, 2025 | $ | |||||||||||
| Vested and expected to vest at June 30, 2025 | $ | |||||||||||
The fair value of stock option awards is estimated at the date of grant using the Black-Scholes option-pricing model. The estimated fair value of each stock option is then expensed over the requisite service period, which is generally the vesting period (ranging between immediate vesting and four years). The determination of fair value using the Black-Scholes model is affected by the Company’s share price as well as assumptions regarding a number of complex and subjective variables, including expected price volatility, expected life, risk-free interest rate, and forfeitures. Forfeitures are accounted for as they occur.
Stock options granted during the six months ended June 30, 2025 were valued using the Black-Scholes option-pricing model with the following weighted-average assumptions.
Schedule of Options Weighted Average Assumptions
| For the six months ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Expected volatility | % | N/A | ||||||
| Risk-free interest rate | % | N/A | ||||||
| Expected dividend yield | % | N/A | ||||||
| Expected life of options in years | N/A | |||||||
| Estimated fair value of options granted | $ | N/A | ||||||
| F-13 |
The
weighted-average grant date fair value of stock options granted during six months ended June 30, 2025 was approximately $
Total stock-based compensation expense included in the accompanying condensed consolidated statements of operations was as follows:
Schedule of Stock-Based Compensation Expense
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
For the three months ended June 30, | For the six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Research and development | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Total stock-based compensation | $ | $ | $ | $ | ||||||||||||
As
of June 30, 2025, the total unrecognized compensation expense related to non-vested options was approximately $
Warrants
In
connection with the IPO, the Company issued warrants to purchase such number of shares of the Company’s common stock equal to 5%
of the total shares of common stock issued in the IPO, or
In
May 2023, the Company issued warrants to designees of the underwriter (the “Representative’s Warrants”) to purchase
In
November 2023, the Company issued the underwriters from a private placement offering warrants to purchase
| F-14 |
In
connection with the June 2024 PIPE Offering as described in Note 4 to the condensed consolidated financial statements, the Company issued
the June 2024 Pre-Funded Warrants to purchase
In
connection with the December 2024 PIPE Offering as described in Note 4 to the condensed consolidated financial statements, the Company
issued the December 2024 Pre-Funded Warrants to purchase
In
connection with the June 2025 PIPE Offering as described in Note 4 to the condensed consolidated financial statements, the Company issued
the June 2025 Pre-Funded Warrants to purchase
Terms of the warrants outstanding at June 30, 2025 are as follows:
Schedule of Warrants
| Initial | Expiration | Exercise | Warrants | Warrants | Warrants | |||||||||||||||
| Issuance Date | Exercise Date | Date | Price | Issued | Exercised | Outstanding | ||||||||||||||
| $ | - | |||||||||||||||||||
| $ | - | |||||||||||||||||||
| $ | - | |||||||||||||||||||
| N/A | $ | |||||||||||||||||||
| $ | - | |||||||||||||||||||
| $ | - | |||||||||||||||||||
| $ | - | |||||||||||||||||||
| N/A | $ | - | ||||||||||||||||||
| N/A | $ | - | ||||||||||||||||||
| $ | - | |||||||||||||||||||
| $ | - | |||||||||||||||||||
Restricted Stock Units
During
the six months ended June 30, 2025, as stock-based consideration for consulting services, the Company granted restricted stock units
(“RSUs”) under the 2023 Plan to an individual representing the right to receive one share of the Company’s common stock.
The grant date fair value of an RSU represents the closing price of the Company’s common stock on the date of grant. The estimated fair value of each RSU is then expensed over the requisite service period, which is generally the vesting period (approximately a year and a half).
The
total stock compensation expense related to RSUs for the three and six months ended June 30, 2025 was $
Termination Agreement
In
connection with the resignation of a board member, effective June 23, 2025,
Note 6 – Commitments and Contingencies
Research Collaboration and Product License Agreement with Minotaur Therapeutics, Inc. (“Minotaur”) and Commercial License Agreement with Taurus Biosciences, LLC (“Taurus”)
The Company has entered into a research collaboration and product license agreement with Minotaur (as amended, the “Minotaur Agreement”) and a commercial license agreement with Taurus (the “Taurus Agreement”) for use of certain technology, including OmniAb antibodies, to advance Picobodies against novel, unreachable, and undruggable epitopes in high-value validated targets starting with PD-1. The Minotaur Agreement and Taurus Agreement are for the development of proprietary targeted biologics, including TH 1940, against PD-1. It is anticipated that the Company will collaborate with Minotaur under the license from Taurus to discover, develop, and advance biotherapeutics against high-value validated IO targets starting with PD-1.
| F-15 |
The
Minotaur Agreement included an up-front payment of $
Research and Development Collaboration and License Agreement with Applied Biomedical Science Institute
On July 5, 2023 (the “ABSI Effective Date”), the Company entered into a Research and Development Collaboration and License Agreement (the “ABSI Agreement”) with ABSI pursuant to which ABSI granted the Company an exclusive royalty-bearing, sublicensable license to the ABSI Patents (as defined in the ABSI Agreement) and a non-exclusive, royalty-bearing, sublicensable license to the ABSI Know-How (as defined in the ABSI Agreement) to Exploit (as defined in the ABSI Agreement) the ABSI Products (as defined in the ABSI Agreement) for the treatment, diagnosis, prediction, detection or prevention of disease in humans and animals worldwide (the “Territory”).
Pursuant to the ABSI Agreement, the parties shall form a committee to manage the preclinical, investigational new drug enabling studies and such other activities as shall lead to the initiation of a Phase 1 clinical trial of the ABSI Product. The parties will collaborate on a Target-by-Target basis to identify and evaluate ABSI Products directed against such Target (as defined below) with a view to identifying or generating suitable Products (as defined in the ABSI Agreement) for the Company to Exploit. “Target” means ErB2 (Her2) and ErbB3. Upon completion of the Discovery Timeline (as defined in the ABSI Agreement) for a Target, subject to the terms and conditions of ABSI Agreement, the Company shall exclusively own any ABSI Products against such Target. In the event the committee determines that the discovery activities are unsuccessful with respect to a Target, the Company may propose an additional target, which, upon approval by ABSI, shall replace a failed Target.
Pursuant
to the ABSI Agreement: (i) the Company issued ABSI
On a Product-by-Product basis, upon the expiration of the last Royalty Term of such Product in the Territory, licenses granted to the Company with respect to such Product shall be deemed non-exclusive, fully paid, royalty-free, perpetual and irrevocable. The ABSI Agreement shall expire upon the expiration of the last Royalty Term of the last Product, unless such agreement is terminated earlier pursuant to its terms. The ABSI Agreement may also be terminated (i) by either the Company or ABSI for (A) a material breach of the ABSI Agreement or (B) bankruptcy, (ii) ABSI may terminate the ABSI Agreement upon the commencement of a Challenge Proceeding (as defined in the ABSI Agreement) or (iii) the Company may terminate the ABSI Agreement at any time upon 90 days prior written notice to ABSI. Upon termination or expiration of the ABSI Agreement other than as a result of a bankruptcy or Challenge Proceeding, all licenses granted to the Company pursuant to such agreement will terminate and all rights under such licenses shall revert to ABSI.
| F-16 |
On
March 11, 2024, the Company entered into an addendum to the ABSI Agreement to fund research services with quarterly payments of $
Avior Patent License Agreement
On
November 3, 2023 (the “Avior Effective Date”), the Company entered into the Avior Patent License Agreement with Avior pursuant
to which the Company received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among
other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize TH104 and TH103 and to practice the
Licensed Technology in connection with the foregoing, throughout the world. Pursuant to the Avior Patent License Agreement, the Company
paid Avior an up front license fee of $
During
the three and six months ended June 30, 2025, the Company paid
| F-17 |
Enkefalos License Agreement
On
June 17, 2024 (the “Enkefalos Effective Date”), the Company signed a letter of intent to enter into the Enkefalos License
Agreement with Enkefalos Biosciences Inc. (“Enkefalos”) pursuant to which the Company is licensing the global rights in all
fields of use for the products related to the compounds knows as cyclotides to deliver HER2 antibodies across the blood-brain barrier
and all associated know-how, technology, intellectual property and related information and constructs, and any associated authorized
generic rights and all related assets (collectively, the “Products” referred to in this letter as ENBI-01) from Enkefalos.
This agreement was terminated during the six months ended June 30, 2025. Pursuant to the Enkefalos License Agreement, the Company paid
Enkefalos an up-front license fee of $
Intract Patent License Agreement
On
September 11, 2024, the Company entered into the Intract Agreement pursuant to which the Company exclusively licensed INT-023/TH023,
an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab. Under the terms of the Intract Agreement, the
Company licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral®
delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. Pursuant
to the Intract Agreement, the Company paid Intract an up-front license fee of $
During
the three and six months ended June 30, 2025, the Company incurred fees of $
Employment Agreements
On
July 6, 2023, the Company entered into an amended and restated employment agreement (the “Former CEO Employment Agreement”)
with the now former CEO. The Former CEO Employment Agreement had the same terms as the COO Employment Agreement (as defined below) except,
the CEO (i) would receive a base salary of $
| F-18 |
In
connection with the appointment of the Company’s Chief Operating Officer on July 11, 2023, the Company entered into an employment
agreement (the “COO Employment Agreement”) with the COO. The COO Employment Agreement shall continue for a period of five
years and, thereafter, shall automatically renew for successive one-year terms unless either party provides the other party with written
notice of non-renewal at least 60 days prior to the last day of the then-current term. Pursuant to the COO Employment Agreement, the
COO would: (i) receive a base salary of $
In
accordance with the Former CEO Employment Agreement and COO Employment Agreement, the compensation committee approved a bonus of 50%
in equity compensation and 50% in cash compensation on January 13, 2025, based on corporate performance objectives earned during the
year ended December 31, 2024. The former CEO’s equity bonus for the year ended December 31, 2024 was made up of options to purchase
up to
In
connection with the appointment of the Company’s Executive Chairman of the Board (the “Chairman”), on June 11, 2025,
the Company entered into an employment agreement with the Chairman (the “Chairman Employment Agreement”). The Chairman Employment
Agreement shall continue for a period of five years and, thereafter, shall automatically renew for successive one year terms unless either
party provides the other party with written notice of non-renewal at least 60 days prior to the last day of the then current term. Pursuant
to the Chairman Employment Agreement, the Chairman shall: (i) receive a base salary of $
In the event that the Chairman’s employment is terminated by the Company other than as a result of his death or disability and other than for cause, or if the Chairman terminates his employment for Good Reason (as defined in the Chairman Employment Agreement), then, in addition to accrued compensation, the Company shall (i) continue to pay his base salary and provide health benefits for a period of 12 months following the termination date or, in the case of benefits, such time as he receives equivalent coverage and benefits under plans and programs of a subsequent employer; and (ii) provide such other or additional benefits, if any, as may be provided under applicable employee benefit plans, programs and/or arrangements of the Company (other than any severance plans or programs). In addition, all unvested time-based equity awards (including restricted shares and stock options) shall be immediately and fully accelerate and become vested. Moreover, stock options that have vested as of the termination date shall remain exercisable until the earlier of (i) 60 months following such termination and (ii) the expiration date of the stock option. As noted, the terms of the COO Employment Agreement were amended to mirror the terms of the Chairman Employment Agreement.
As
of June 30, 2025, there was accrued bonus of less than $
Note 7 – Related Party Transactions
Related Party Ownership
The
Company’s Chairman is a partner and licensed broker at President Street Global, a consultant for the Company. His combined ownership,
both individually and through President Street Global, is approximately
The
CEO, individually as well as through companies he serves as managing member and managing partner, collectively owns
Note 8 – Subsequent Events
Except as noted below, there were no material subsequent events that required recognition or additional disclosure in these condensed consolidated financial statements.
On
July 23, 2025, the Company entered into a securities purchase agreement in relation to a registered direct public offering with certain
purchasers, under a Shelf Registration Statement, of $
On July 25, 2025, the Company entered into a securities purchase agreement with certain accredited individual and
institutional investors for the issuance and sale in a private placement of (i)
On August 4, 2025, the Company’s board of directors appointed Nancy Davis as a member of the Board effective as of August 4, 2025. Ms. Davis will serve for a term expiring at the 2026 annual meeting of stockholders.
| F-19 |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited interim condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as may be amended, supplemented, or superseded from time to time by other reports we file with the SEC. All amounts in this report are in U.S. dollars, unless otherwise noted.
Throughout this Quarterly Report on Form 10-Q, references to “we,” “our,” “us,” the “Company,” or “Tharimmune,” refer to Tharimmune, Inc., individually, or as the context requires, collectively with its subsidiary.
Overview
Tharimmune is a clinical-stage biotechnology company developing therapeutic candidates in immunology and inflammation conditions with high unmet need. On November 3, 2023, we entered into a patent license agreement (the “Avior License Agreement”) with Avior Inc. d/b/a Avior Bio, LLC (“Avior”) pursuant to which we received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and commercialize TH104 and TH103 and to practice the Licensed Technology in connection with the foregoing, throughout the world (each as defined in the Avior License Agreement). In February 2023, the U.S. Food and Drug Administration (“FDA”) approved an investigational new drug (“IND”) application for TH104. TH104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritus or “uncontrollable itching.” With respect to TH104, we originally intended to first seek approval for the treatment of moderate-to-severe chronic pruritus in patients with primary biliary cholangitis (“PBC”), an orphan rare form of liver disease with no known cure in which more than 70% of patients suffer from debilitating chronic pruritic. In March 2025, we engaged and received positive feedback from the FDA regarding the additional proposed indication of temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids (“PrHPO”), for which we submitted a Pre-Investigational New Drug Application (“PIND”). With respect to our PIND for this additional proposed indication for TH104, the Company received positive feedback from the FDA regarding a regulatory pathway that will allow the Company to submit a 505(b)(2) New Drug Application (“NDA”) for TH104. The FDA advised that we will need to perform additional nonclinical studies (i.e., in vitro toxicology studies), but the FDA confirmed that it does not believe any additional clinical trials will be required to define the prophylactic dosing window prior to IND or NDA submission for this indication, which we expect will be the lead program for the Company. The Company intends to pursue the pruritus in PBC indication subsequent to the nearer term opportunity of filing an NDA for PrHPO. The Company intends to conduct a capital efficient strategy to file an NDA for PrHPO, which involves actively progressing its Chemistry, Manufacturing, and Controls (“CMC”) plan to meet the stringent requirements for filing an NDA with the FDA. This comprehensive plan encompasses all aspects of the manufacturing process, quality control measures, and product stability to ensure the consistent production of a high-quality buccal film formulation known as TH104.
On September 11, 2024, we entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited (“Intract”), pursuant to which, we exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab. Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor TNF-α. Under the terms of the Intract Agreement, we licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program.
We are also developing an early-stage pipeline of novel therapeutic candidates targeting validated high value immuno-oncology (“IO”) targets including human epidermal growth factor (“EGF”) receptor 2 (“HER2”), human EGF receptor 3 (“HER3”) and programmed cell death protein 1 (“PD-1”). We are developing antibodies including bispecific antibodies, antibody drug conjugates (“ADCs”) and small molecular weight bovine-derived “knob” domains which have the potential to target and bind more tightly to “undruggable” epitopes better than full sized antibodies. We are advancing HS1940, a bispecific biologic against both PD-1 and vascular endothelial growth receptor (“VEGF”) antibody which targets both receptors. In addition, we have completed initial pre-clinical in-vitro testing for HS3215, a HER2/HER3 bispecific antibody.
The critical components of our business strategy to achieve our goals include:
| ● | Develop TH104 as a transmucosal buccal film product for temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders entering and area contaminated with high-potency opioids; | |
| ● | Develop TH104 as a transmucosal buccal film product for the treatment of moderate-to-severe chronic pruritus in PBC and other inflammatory diseases either through strategic partnership or on our own; | |
| ● | Develop TH023 by obtaining regulatory authorization to initiate a first-in-human bioavailability clinical trial and pursue an IND through the FDA post optimizing its CMC program; |
| 4 |
| ● | Create a preclinical and clinical path forward for, HS1940, with a unique PD-1 knob-domain antibody fragment as a bispecific biologic against PD-1 and VEGF with unique binding differentiation for IO vulnerable tumors; | |
| ● | Continue to advance pre-clinical candidate selection activities against HER2/HER3 receptors with various antibody formats, including HS3215 designed for multiple solid tumor types; | |
| ● | Hasten the discovery of next generation multi-specific (bi- and tri) antibodies with binding capabilities to novel epitopes of combinations of HER2 and HER3 with and without toxin delivery capacity to multiple high unmet need rare cancers and other validated immunology and metabolic targets; and | |
| ● | Pursue strategic collaboration opportunities including partnering and potential merger and acquisition transactions to maximize the value of our pipeline to bring novel therapies to patients suffering from high unmet need conditions. |
License Agreements
Applied Biomedical Research Institute Research and Development Collaboration and License Agreement
On July 5, 2023, we entered into the ABSI Agreement with ABSI pursuant to which ABSI granted us an exclusive royalty-bearing, sublicensable license to the ABSI Patents and a non-exclusive, royalty-bearing, sublicensable license to the ABSI Know-How to Exploit the ABSI Products for the treatment, diagnosis, prediction, detection or prevention of disease in humans and animals worldwide. Pursuant to the ABSI Agreement, the parties shall form a committee to manage the preclinical, IND-enabling studies and such other activities as shall lead to the initiation of a Phase 1 clinical trial of the ABSI Product. The parties will collaborate on a Target-by-Target basis to identify and evaluate ABSI Products directed against such Target with a view to identifying or generating suitable Products for our Company to Exploit. “Target” means ErB2 (Her2) and ErbB3. Upon completion of the Discovery Timeline for a Target, subject to the terms and conditions of ABSI Agreement, we shall exclusively own any ABSI Products against such Target. In the event the committee determines that the discovery activities are unsuccessful with respect to a Target, we may propose an additional target, which, upon approval by ABSI, shall replace a failed Target, each capitalized term as defined in the ABSI Agreement.
On March 11, 2024, we entered into an addendum to the ABSI Agreement to fund research services with quarterly payments of $50,000 beginning March 18, 2024 with subsequent payments due on the 18th of each calendar quarter. This addendum was terminated on July 17, 2025 and no further payments are due under the addendum for research services.
Avior Patent License Agreement
On November 3, 2023, we entered into the Avior Patent License Agreement with Avior pursuant to which we received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among other things, develop, have developed, make, have made, use, sell, import, export and commercialize TH104 and TH103 and to practice the Licensed Technology in connection with the foregoing, throughout the world. Pursuant to the Avior Patent License Agreement, we paid Avior an up front license fee of $0.4 million and a quarterly license fee of $0.15 million each quarter in 2024. In addition, we shall pay Avior a high single digit percentage of any upfront payments received by us as a result of the grant of any sublicenses with respect to TH104. We shall also pay Avior milestone payments in the aggregate amount of $24.25 million upon the occurrence of various development milestones (the “Development Milestone Payments”). Furthermore, we shall pay Avior certain fees based upon sales milestones. The payments for such sales milestones range from the low seven digits to the low eight digits with higher sales being subject to higher fees. Finally, we shall pay Avior royalties based on net sales. Such royalties range from low single digit percentages to mid-single digit percentages with higher sales being subject to lower percentages. All capitalized terms not otherwise defined herein shall have the meanings ascribed to them in the Avior Patent License Agreement.
| 5 |
Intract Patent License Agreement
On September 11, 2024, we entered into the Intract Agreement with Intract, pursuant to which the Company exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab. Under the terms of the Intract Agreement, we licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development program. Pursuant to the Intract Agreement, we paid an upfront license fee of $0.4 million and are required to make additional payments upon an equity financing of the Company. Intract is eligible to receive future development, regulatory and commercial milestones, as well as mid-single digit royalties based on net product sales. Under the terms of the Intract Agreement, we retain a right of first refusal to continue development and commercialization after a Phase 2 clinical trial and have the option to exercise the license to Intract’s platform for up to four additional targets. The term of the Intract Agreement expires upon the final payment obligation of the Company under the Intract Agreement. In addition, the Intract Agreement may be terminated by us at any time upon 90 days written notice to Intract. Either party may terminate the Intract Agreement if the other party materially breaches any provision of the Intract Agreement and fails to cure such breach within 30 days after the breaching party receives written notice thereof. In addition, either party may terminate the Intract Agreement on written notice in the event that either party declare: (a) becomes insolvent or admits inability to pay its debts generally as they become due; (b) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully dismissed or vacated within 60 days; (c) is dissolved or liquidated or takes any corporate action for such purpose; (d) makes a general assignment for the benefit of creditors; or (e) has a receiver, trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business. On March 14, 2025 we amended the Intract Agreement to pay the milestone due upon closing of our December 2024 PIPE Offering in equal installments over the next 12 months, with the first payment beginning in the second quarter of 2025.
Recent Developments
On June 7, 2024, we entered into an at-the-market offering agreement (the “ATM Agreement”) with Rodman & Renshaw LLC (the “ATM Sales Manager”) under which we may sell, from time to time through the ATM Sales Manager, shares of common stock in one or more offerings up to a total dollar amount of $1.65 million.
To date, we have sold 203,359 shares pursuant the ATM Agreement for net proceeds of approximately $0.3 million, after deducting commissions of $15,505 and other offering expenses of $33,600. See Note 4 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
In addition, on July 23, 2025, we entered into a securities purchase agreement in relation to a registered direct public offering with certain purchasers, under a Shelf Registration Statement, of $1.74 million of our securities, consisting of (i) 414,331 shares of Common Stock, par value $0.0001 per share and 559,910 pre-funded warrants to acquire shares of Common Stock; and (ii) in a concurrent private placement, 974,241 warrants to acquire shares of Common Stock at the exercise price of $1.66 per share, at the price of $1.786 for each one share of Common Stock or Pre-Funded Warrant, and Common Warrant. The offering closed on July 25, 2025.
Components of Results of Operations
Revenue
We did not recognize revenues for the three and six months ended June 30, 2025 and 2024.
| 6 |
Research and Development Expenses
Research and development expenses include personnel costs associated with research and development activities, including third-party contractors to perform research, conduct clinical trials, and manufacture drug supplies and materials as well as stock-based compensation for our research and development personnel. Research and development expenses are charged to operations as incurred.
We accrue costs incurred by external service providers, including contract research organizations and clinical investigators, based on estimates of service performed and costs incurred. These estimates include the level of services performed by third parties, patient enrollment in clinical trials, administrative costs incurred by third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, we may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered.
We have incurred research and development expenses related to the development of HSB-1216, which has been deprioritized. We expect that our research and development expenses will increase as we plan for and commence our clinical trials of HS1940 and HS3215.
We cannot determine with certainty the duration and costs of future clinical trials of our product candidates, HS1940 and HS3215, or any other product candidates we may develop or if, when or to what extent we will generate revenue from the commercialization and sale of any of our product candidates for which we obtain marketing approval. We may never succeed in obtaining marketing approval for any of our product candidates. The duration, costs and timing of clinical trials and development of our current and future product candidates will depend on a variety of factors, including:
| ● | the scope, rate of progress, expense and results of clinical trials of our current product candidates, as well as of any future clinical trials of our future product candidates and other research and development activities that we may conduct; |
| ● | uncertainties in clinical trial design and patient enrollment rates; |
| ● | the actual probability of success for our product candidates, including their safety and efficacy, early clinical data, competition, manufacturing capability and commercial viability; |
| ● | significant and changing government regulations and regulatory guidance; and |
| ● | the timing and receipt of any marketing approvals. |
A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to slower than expected patient enrollment or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development.
General and Administrative Expenses
General and administrative expenses consist primarily of compensation and consulting related expenses, including stock-based compensation for our general and administrative personnel. General and administrative expenses also include professional fees and other corporate expenses, including legal fees relating to corporate matters; professional fees for accounting, auditing, tax, and consulting services; insurance costs; travel expenses and other operating costs that are not specifically attributable to research activities.
We expect that our general and administrative expenses will increase in the future as we increase our personnel headcount to support our continued research activities and development of our product candidates. We also incur expenses associated with being a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, directors and officers insurance expenses, corporate governance expenses, investor relations activities and other administrative and professional services.
| 7 |
Interest Income
Interest income consists of interest income from funds held in our cash accounts.
Deferred Offering Costs
Deferred offering costs consisted of legal, accounting, printing, and filing fees that were capitalized and offset against the proceeds from our securities offerings. At June 30, 2025, deferred offering costs of approximately $92,000 represent professional services incurred related to the At the Market Offering Agreement (the “ATM Agreement”), through which the Company may sell, from time to time through the applicable sales manager, shares of common stock in one or more offerings up to a total dollar amount of $1.65 million. See Notes 2 and 4 to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Results of Operations
Three Months Ended June 30, 2025 Compared to the Three Months Ended June 30, 2024
Three Months Ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| Condensed Consolidated Statements of Operations Data: | ||||||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 546,204 | $ | 999,553 | $ | (453,349 | ) | |||||
| General and administrative | 1,304,956 | 1,373,901 | (68,945 | ) | ||||||||
| Total operating expenses | 1,851,160 | 2,373,454 | (522,294 | ) | ||||||||
| Other expense: | ||||||||||||
| Interest expense | (6,161 | ) | (5,217 | ) | (944 | ) | ||||||
| Interest income | 2,168 | 53,614 | (51,446 | ) | ||||||||
| Total other income (expense), net | (3,993 | ) | 48,397 | (52,390 | ) | |||||||
| Net loss | $ | (1,855,153 | ) | $ | (2,325,057 | ) | $ | 469,904 | ||||
Research and Development Expenses
The table below summarizes by program our research and development expenses for the periods presented:
Three Months Ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| HS1940 | $ | 69,197 | $ | 122,500 | $ | (53,303 | ) | |||||
| HS3215 | 43,341 | 281,219 | (237,878 | ) | ||||||||
| TH023 | 62,500 | - | 62,500 | |||||||||
| TH104 | 274,783 | 355,603 | (80,820 | ) | ||||||||
| Other research and development | 96,383 | 240,231 | (143,848 | ) | ||||||||
| Total research and development expenses | $ | 546,204 | $ | 999,553 | $ | (453,349 | ) | |||||
Research and development expenses decreased by approximately $0.5 million, or 45%, to approximately $0.5 million for the three months ended June 30, 2025 from approximately $1.0 million for three months ended June 30, 2024. The decrease was primarily the result of a decrease in pre-clinical vendor expenses of approximately $0.3 million and license fees of approximately $0.4 million. These decreases were offset by increases in stock-based compensation of approximately $0.2 million.
General and Administrative Expenses
General and administrative expenses decreased by approximately $0.1 million, or 5%, to $1.3 million for the three months ended June 30, 2025 from $1.4 million for the three months ended June 30, 2024. The change in general and administrative expenses was primarily due to a decrease in personnel expenses of approximately $0.3 million, offset by an increase in investor relations fees of $0.2 million.
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Interest Expense
Interest expense increased by approximately $1,000, or 18%, to $6,161 for the three months ended June 30, 2025 from $5,217 for the three months ended June 30, 2024. The increase in interest expense was primarily related to the director and officer insurance premium financing liability as well as the note payable related to the legal fees settlement.
Interest Income
Interest income decreased by approximately $51,000, or 96%, to $2,168 for the three months ended June 30, 2025 from $53,614 for the three months ended June 30, 2024. The decrease in interest income was primarily due to the decrease in cash from June 2024 to June 2025.
Six Months Ended June 30, 2025 Compared to the Six Months Ended June 30, 2024
Six Months Ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| Condensed Consolidated Statements of Operations Data: | ||||||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 1,140,274 | $ | 2,024,811 | $ | (884,537 | ) | |||||
| General and administrative | 3,257,555 | 2,695,946 | 561,609 | |||||||||
| Total operating expenses | 4,397,829 | 4,720,757 | (322,928 | ) | ||||||||
| Other expense: | ||||||||||||
| Interest expense | (14,632 | ) | (9,917 | ) | (4,715 | ) | ||||||
| Interest income | 15,604 | 149,508 | (133,904 | ) | ||||||||
| Total other income (expense), net | 972 | 139,591 | (138,619 | ) | ||||||||
| Net loss | $ | (4,396,857 | ) | $ | (4,581,166 | ) | $ | 184,309 | ||||
Research and Development Expenses
The table below summarizes by program our research and development expenses for the periods presented:
Six Months Ended June 30, | ||||||||||||
| 2025 | 2024 | Change | ||||||||||
| HS1940 | $ | 140,034 | $ | 264,147 | $ | (124,113 | ) | |||||
| HS3215 | 120,953 | 281,219 | (160,266 | ) | ||||||||
| TH023 | 132,557 | - | 132,557 | |||||||||
| TH104 | 579,268 | 614,332 | (35,064 | ) | ||||||||
| Other research and development | 167,462 | 865,113 | (697,651 | ) | ||||||||
| Total research and development expenses | $ | 1,140,274 | $ | 2,024,811 | $ | (884,537 | ) | |||||
Research and development expenses decreased by $0.9 million, or 44%, to $1.1 million for the six months ended June 30, 2025 from $2.0 million for six months ended June 30, 2024. The decrease was primarily the result of a decrease in pre-clinical vendor expenses of approximately $0.5 million, license fees of approximately $0.4 million, and clinical trials of approximately $0.2 million. These decreases were offset by increases in stock-based compensation of approximately $0.2 million and other small increases.
General and Administrative Expenses
General and administrative expenses increased by $0.6 million, or 21%, to $3.3 million for the six months ended June 30, 2025 from $2.7 million for the six months ended June 30, 2024. The change in general and administrative expenses was primarily due to increases of approximately $0.3 million in stock compensation expense, approximately $0.5 million in investor relations, and approximately $0.2 million in director remuneration. The increases were offset by approximately $0.4 million in decreases in personnel expense.
Interest Expense
Interest expense increased by approximately $5,000, or 48%, to $14,632 for the six months ended June 30, 2025 from $9,917 for the six months ended June 30, 2024. The increase in interest expense was primarily related to the director and officer insurance premium financing liability as well as the note payable related to the legal fees settlement.
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Interest Income
Interest income decreased by approximately $0.1 million, or 90%, to $15,604 for the six months ended June 30, 2025 from $149,508 for the six months ended June 30, 2024. The decrease in interest income was primarily due to the decrease in cash from June 2024 to June 2025.
Liquidity and Capital Resources
The accompanying condensed consolidated financial statements have been prepared on the basis that we will continue as a going concern, which contemplates, among other things, the realization of assets and satisfaction of liabilities in the normal course of business. During the six months ended June 30, 2025, we incurred operating losses in the amount of approximately $4.4 million, expended approximately $3.8 million of net cash in operating activities, and had an accumulated deficit of approximately $41.3 million as of June 30, 2025. Through June 30, 2025, we have primarily financed our operations through public and private offerings of our equity securities.
In April and May 2025, we raised net proceeds of $0.2 million pursuant to the ATM Agreement from the sale of 163,359 shares of our common stock at an average price of $1.63 per share, after deducting sales agent commissions and other offering fees.
Further, on June 17, 2024, December 9, 2024, and June 13, 2025, we closed private placement offerings (the “June 2024 PIPE Offering,” “December 2024 PIPE Offering”, and “June 2025 PIPE Offering,” respectively) with certain accredited investors, consisting of offerings of shares of our common stock and/or pre-funded warrants to acquire shares of our common stock and warrants to acquire shares of our common stock, with combined net proceeds of approximately $5.9 million.
Based on our limited operating history, recurring negative cash flows from operations, current plans and available resources, we will need substantial additional funding to support future operating activities. We have concluded that the prevailing conditions and ongoing liquidity risks faced by us raise substantial doubt about our ability to continue as a going concern for at least one year following the date the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued. The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary should we be unable to continue as a going concern.
We may seek to raise additional funding through the sale of additional equity or debt securities, enter into strategic partnerships, grants or other arrangements or a combination of the foregoing to support our future operations; however, there can be no assurance that we will be able to obtain additional capital on terms acceptable to us, on a timely basis, or at all. The failure to obtain sufficient additional funding could adversely affect our ability to achieve our business objectives and product development timelines and may result in us delaying or terminating clinical trial activities which could have a material adverse effect on our results of operations.
Cash Flow Activities for the Six Months Ended June 30, 2025 and 2024
The following table sets forth a summary of our cash flows for the periods presented.
| Six Months Ended June 30, | ||||||||
| 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 Flows from Operating Activities
Cash used in operating activities for the six months ended June 30, 2025 was $3.8 million, which consisted of net loss of $4.4 million and net changes in operating assets and liabilities of approximately $0.2 million, partially offset by non-cash stock-based compensation of approximately $0.8 million.
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Cash used in operating activities for the six months ended June 30, 2024 was $5.1 million, which consisted of net loss of $4.6 million, increase in prepaid and other current assets of $0.3 million and decrease in operating liabilities of $0.5 million, partially offset by non-cash stock-based compensation and stock issuance of $0.3 million.
Cash Flows from Financing Activities
Cash provided by financing activities for the six months ended June 30, 2025 was $2.5 million. The net increase in financing activities was due to gross proceeds from the June 2025 PIPE Offering of $2.5 million, ATM offerings of $0.3 million, and insurance premium financing liability of $0.3 million, offset by payments of deferred offering costs of $0.3 million, repayments of insurance premium financing liability of $0.2 million, and repayments of the note payable of $0.1 million.
Cash provided by financing activities for the six months ended June 30, 2024 was $2.0 million. The net increase in financing activities was due to proceeds from the insurance premium financing liability of $0.3 million, offset by repayments of insurance premium financing liability of $0.1 million.
Reverse Stock Split
On May 24, 2024, the Company effectuated an additional reverse split of shares of its common stock at a ratio of 1-for-15 pursuant to an amendment to the Company’s Certificate of Incorporation, as amended, filed with the Delaware Secretary of State and approved by the Company’s board of directors and stockholders. The par value of the Company’s common stock was not adjusted as a result of this or any prior reverse split. All issued and outstanding common stock share and per share amounts contained in the accompanying condensed consolidated financial statements have been retroactively adjusted to reflect this and any prior reverse split for all periods presented.
Critical Accounting Policies and Use of Estimates
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: research and development expense recognition, stock-based compensation, allowances of deferred tax assets, and cash flow assumptions regarding going concern considerations. Although management believes the estimates that have been used are reasonable, actual results could vary from the estimates that were used.
Critical Accounting Policies
Research and development
Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including third-party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials. We accrue for costs incurred by external service providers, including contract research organizations and clinical investigators, based on our estimates of service performed and costs incurred. These estimates include the level of services performed by third parties, patient enrollment in clinical trials, administrative costs incurred by third parties, and other indicators of the services completed.
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Stock-based compensation
Stock-based compensation represents the cost related to stock-based awards granted to our employees, directors, consultants, and affiliates. We measure stock-based compensation costs at the grant date, based on the estimated fair value of the award and recognize the cost over the requisite service period.
We recognize compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in the condensed consolidated statements of operations over the requisite service period based on a measurement of fair value for each stock-based award. The fair value of each option grant to employees, non-employees and directors is estimated as of the date of grant using the Black-Scholes option-pricing model, net of actual forfeitures. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. Prior to January 12, 2022, we were a private company and our common stock has only been publicly traded since that date. As a result, we lack company-specific historical and implied volatility information. Therefore, we have estimated our expected stock price volatility based on the historical volatility of a publicly traded set of peer companies. The expected term of stock options granted was between five and seven years. The risk-free interest rate was determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award.
Recently Issued and Adopted Accounting Standards
See Note 2 to our condensed consolidated financial statements included elsewhere in this quarterly Report on Form 10-Q.
JOBS Act
On April 5, 2012, the Jumpstart Our Business Startups Act (the “JOBS Act”) was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.
We have chosen to take advantage of the extended transition periods available to emerging growth companies under the JOBS Act for complying with new or revised accounting standards until those standards would otherwise apply to private companies provided under the JOBS Act. As a result, our financial statements may not be comparable to those of companies that comply with public company effective dates for complying with new or revised accounting standards.
Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, including, without limitation, (i) providing an auditor’s attestation report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended, and (ii) complying with the requirement adopted by the Public Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on financial statements. We will remain an “emerging growth company” until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public offering; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
The Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined in Rule 12b-2 of the Exchange Act.
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ITEM 4. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
Our principal executive officer and principal financial officer evaluated the effectiveness of our “disclosure controls and procedures” as of June 30, 2025, the end of the period covered by this Quarterly Report on Form 10-Q. The term “disclosure controls and procedures” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files under the Exchange Act is accumulated and communicated to a company’s management, including its principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Based on the evaluation of our disclosure controls and procedures as of June 30, 2025, our Chief Executive Officer and our Interim Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective.
Changes in Internal Control over Financial Reporting
Except as set forth above, there were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating the disclosure controls and procedure, management recognizes that any controls and procedures, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedure relative to their costs.
PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm our business. We are currently not aware of any such legal proceedings or claims that will have, individually or in the aggregate, a material adverse effect on our business, financial condition or operating results.
ITEM 1A. RISK FACTORS.
Risk factors that affect our business and financial results are discussed in Part I, Item 1A “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 26, 2025 (“Annual Report”). There have been no material changes in our risk factors from those previously disclosed in our Annual Report. You should carefully consider the risks described in our Annual Report which could materially affect our business, financial condition or future results. The risks described in our Annual Report are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results. If any of the risks actually occur, our business, financial condition, and/or results of operations could be negatively affected.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
None.
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ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
ITEM 5. OTHER INFORMATION.
During
the fiscal quarter ended June 30, 2025, none of the Company’s directors or executive officer
ITEM 6. EXHIBITS.
| Exhibit No. | Description | |
| 4.1 | Form of Pre-Funded Warrant Agreement (Incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 20, 2025) | |
| 4.2 | Form of Series A Warrant (Incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on June 20, 2025) | |
| 4.3 | Form of Series B Warrant (Incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed with the SEC on June 20, 2025) | |
| 10.1*+ | Settlement and General Release Agreement by and between the Company and Randy Milby dated June 11, 2025 | |
| 10.2*+ | Amended and Restated Employment Agreement by and between the Company and Sireesh Appajosyula dated June 11, 2025 | |
| 10.3 | Form of Securities Purchase Agreement (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 20, 2025) | |
| 10.4*+ | Employment Agreement by and between the Company and Vincent LoPriore dated June 11, 2025 | |
| 31.1* | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
| 31.2* | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
| 32.1** | Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
| 32.2** | Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
| 101.INS* | Inline XBRL Instance Document | |
| 101.SCH* | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 104* | Cover Page Interactive Data File - the cover page from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 is formatted in Inline XBRL included in the Exhibit 101 Inline XBRL Document Set |
| * | Filed herewith. |
| ** | Furnished herewith. |
| + | Indicates a management contract or any compensatory plan, contract or arrangement. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| THARIMMUNE, INC. | ||
| Date: August 14, 2025 | By: | /s/ Sireesh Appajosyula |
| Sireesh Appajosyula | ||
| Chief Executive Officer | ||
| (Principal Executive Officer) | ||
| Date: August 14, 2025 | By: | /s/ Sireesh Appajosyula |
| Sireesh Appajosyula | ||
| Interim Chief Financial Officer | ||
| (Interim Principal Financial and Accounting Officer) | ||
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FAQ
How much cash did Tharimmune (THAR) have at June 30, 2025?
What was THAR's net loss for the six months ended June 30, 2025?
Did the FDA provide favorable feedback on TH104 for THAR (THAR)?
What financing did Tharimmune complete in June 2025?
What going concern disclosure did THAR include in the 10-Q?
