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

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 34 Shrewsbury Avenue, Red Bank NJ 07701 (Address of principal executive offices) (Zip code) (908) 270-8260 (Registrant's telephone number, including area code) Securities registered pursuant to Section 1 ...

Licensing and Agreements - Tharimmune entered into a patent license agreement with Avior Inc. for TH104 and TH103, receiving an exclusive sublicensable right and license, with an upfront fee of $400,000 and potential milestone payments totaling $24.25 million[386][392]. - The company licensed INT-023/TH023, an oral anti-TNF-α monoclonal antibody, from Intract Pharma, with an upfront fee of $400,000 and mid-single digit royalties based on net product sales[387][394]. - A Research and Development Collaboration Agreement with Applied Biomedical Science Institute was established, granting exclusive rights to ABSI Patents, with a total compensation expense of $250,000 for stock issued[390][391]. - The Enkefalos License Agreement was signed for global rights to cyclotide compounds for HER2 antibodies, with an upfront fee of $150,000 and potential milestone payments up to $8.5 million[393]. - An at-the-market offering agreement was entered into with Rodman & Renshaw LLC, allowing the sale of common stock up to a total amount of $1.65 million[395]. Clinical Development - The FDA approved the IND application for TH104 in February 2023, targeting moderate-to-severe chronic pruritus in patients with primary biliary cholangitis, with topline data expected in Q4 2025[386]. - The Phase 1 clinical trial of TH104 showed an absolute bioavailability (F) of 45.9% compared to intravenous nalmefene, with a median time to maximum concentration (Cmax) of 2.0 hours and a mean half-life (T1/2) of 14 hours[396]. - The FDA provided positive feedback for the Phase 2 clinical trial of TH104, confirming the plan to pursue a 505(b)(2) approval pathway[397]. - The company plans to initiate a hepatic impairment study prior to launching the Phase 2 study for TH104 in early 2025[397]. - Tharimmune is developing a pipeline of novel therapeutic candidates targeting high-value immuno-oncology targets, including bispecific antibodies and antibody drug conjugates, with IND-enabling studies anticipated in 2025[388]. - The company has a strategy to develop HS0059 as a bispecific ADC targeting HER2 and HER3 receptors in high unmet need tumors[389]. Financial Performance - Research and development expenses increased by $2.8 million, or 80%, to $6.4 million for the year ended December 31, 2024, primarily due to clinical trial expenses and increased license fees[415]. - Total operating expenses for the year ended December 31, 2024, were $12.4 million, an increase of $2.98 million compared to $9.46 million in 2023[414]. - The company incurred a net loss of $12.2 million for the year ended December 31, 2024, compared to a net loss of $9.3 million in 2023[414]. - Interest income increased by $97,277, or 64%, to $249,908 for the year ended December 31, 2024, primarily due to increased cash from PIPE offerings[418]. - Net cash used in operating activities for 2024 was $10.9 million, an increase of 49% from $7.3 million in 2023[424][425][426]. - Net cash provided by financing activities decreased to $3.5 million in 2024 from $11.7 million in 2023, a decline of approximately 70%[424][428]. - The net loss for 2024 was $12.2 million, compared to a net loss of $9.3 million in 2023, representing a 31% increase in losses[425][426]. - Cash decrease for 2024 was $7.4 million, contrasting with an increase of $4.4 million in 2023[424]. - Non-cash stock-based compensation for 2024 was approximately $0.7 million, slightly down from $0.8 million in 2023[425][426]. - Proceeds from PIPE offerings in 2024 amounted to $4.1 million, contributing to the financing activities[427]. Company Strategy and Future Outlook - The company has an accumulated deficit of approximately $36.9 million as of December 31, 2024, and will need substantial additional funding to support future operations[420]. - The company plans to continue relying on exemptions under the JOBS Act as an "emerging growth company" until certain revenue or debt thresholds are met[438]. - The company utilizes estimates in financial reporting, which may lead to variances between estimated and actual results[430]. - Research and development costs are expensed as incurred, with significant investments in clinical trials and drug supply manufacturing[431]. - The company executed a reverse stock split at a ratio of 1-for-15 on May 24, 2024[429].

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

Group 1 - Tharimmune is implementing a one-for-15 reverse stock split to consolidate its shares and boost the share price to meet the $1 minimum bid requirement for The Nasdaq Capital Market [1][3] - After the reverse split, Tharimmune will have 785,978 shares of THAR stock remaining [2] - The stock was trading at 33 cents per share prior to the split and has seen a year-to-date decline of 34.5% [3][4] Group 2 - The company aims to remain publicly listed as it is still in the clinical stage of biotechnology, without a product available for sale [4] - As of Friday morning, THAR stock was up 3.7% ahead of the reverse split [4]

Licensing and Collaborations - Tharimmune entered into a patent license agreement with Avior Inc. on November 3, 2023, receiving exclusive rights to develop and commercialize TH104 and TH103, with an upfront license fee in the mid-six digits and additional milestone payments totaling $24.25 million[96][102]. - Tharimmune's strategy includes pursuing collaborations to maximize the value of its pipeline and bring novel therapies to patients with high unmet needs[102]. - The ABSI Agreement includes quarterly payments of $50,000 starting March 18, 2024, for research services related to the development of ABSI Products targeting HER2 and HER3[101]. Clinical Development - The FDA approved the IND application for TH104 in February 2023, targeting moderate-to-severe chronic pruritis in patients with primary biliary cholangitis, where over 70% of patients suffer from debilitating itching[96]. - Tharimmune is advancing TH3215, a bispecific antibody targeting HER2 and HER3, into IND-enabling studies expected in 2025, alongside TH0059 and TH1940, which are also anticipated to enter IND-enabling studies in the same year[97]. - The company completed a Phase 1 clinical trial for TH104, with 19 out of 20 participants completing the study, demonstrating a comparable safety profile to the FDA-approved nalmefene[103]. Financial Performance - Tharimmune has not recognized any revenue for the three months ended March 31, 2024, and 2023[104]. - Total operating expenses decreased by $367,095, or approximately 13.5%, to $2,347,303 for the three months ended March 31, 2024, compared to $2,714,398 for the same period in 2023[116]. - Research and development expenses decreased by $22,419, or 2%, to $1,025,258 for the three months ended March 31, 2024, from $1,047,677 for the same period in 2023[117]. - General and administrative expenses decreased by $344,676, or 21%, to $1,322,045 for the three months ended March 31, 2024, from $1,666,721 for the same period in 2023[118]. - Interest expense decreased by $1,438, or 23%, to $4,700 for the three months ended March 31, 2024, from $6,138 for the same period in 2023[119]. - Interest income increased by $63,646, or 197%, to $95,894 for the three months ended March 31, 2024, from $32,248 for the same period in 2023[120]. - Net loss improved by $432,179, or approximately 16.1%, to $2,256,109 for the three months ended March 31, 2024, compared to $2,688,288 for the same period in 2023[116]. - Cash used in operating activities decreased by $639,509, or approximately 18.4%, to $2,825,181 for the three months ended March 31, 2024, from $3,464,690 for the same period in 2023[126]. - Cash provided by financing activities decreased by $206,245, or approximately 39.3%, to $317,119 for the three months ended March 31, 2024, from $523,364 for the same period in 2023[126]. - The accumulated deficit as of March 31, 2024, was approximately $27.0 million[122]. - The company anticipates needing substantial additional funding to support future operating activities due to recurring negative cash flows[123]. Research and Development Expenses - Research and development expenses are expected to increase as Tharimmune plans to commence clinical trials for TH3215 and TH1940, following the deprioritization of HSB-1216[107]. - General and administrative expenses are projected to rise as the company increases personnel to support ongoing research and development activities[112]. - The company issued 25,107 shares of common stock valued at $9.95 per share as part of the ABSI Agreement, totaling $250,000 in compensation expense[101].

Revenue Recognition - Tharimmune did not recognize any revenue for the years ended December 31, 2023 and 2022[336] Expenses - Research and development expenses increased to $3,559,635 in 2023 from $2,278,424 in 2022, a change of $1,281,211[347] - General and administrative expenses rose to $5,895,585 in 2023 from $4,603,514 in 2022, an increase of $1,292,071[347] - Total operating expenses for 2023 were $9,455,220, up from $6,881,938 in 2022, reflecting a change of $2,573,282[347] - Research and development expenses increased by $1.3 million, or 56.2%, to $3.6 million for the year ended December 31, 2023, from $2.3 million for the year ended December 31, 2022[350] - General and administrative expenses increased by approximately $1.3 million, or 28.1%, to $5.9 million for the year ended December 31, 2023, from $4.6 million for the year ended December 31, 2022[351] Clinical Developments - The FDA approved the IND application for TH104 in February 2023, targeting chronic pruritis in patients with primary biliary cholangitis[330] - Tharimmune entered into a patent license agreement with Avior Inc. on November 3, 2023, involving mid-six digit upfront and milestone payments totaling $24.25 million[335] - The company plans to advance TH3215 and TH1940 into IND-enabling studies in 2024, focusing on high unmet need cancers[331] - Tharimmune has deprioritized the development of HSB-1216 to concentrate on therapeutics for high unmet need cancers[332] - The company expects an increase in research and development expenses as it prepares for clinical trials of TH3215 and TH1940[339] - General and administrative expenses are anticipated to rise as the company increases personnel to support ongoing research activities[343] Financial Performance - Interest expense decreased by $1.6 million, or 99%, to $16,505 for the year ended December 31, 2023, from $1.6 million for the year ended December 31, 2022[352] - Interest income increased by $0.2 million, or 100.0%, to $0.2 million for the year ended December 31, 2023, from $0 for the year ended December 31, 2022[353] - Net loss increased by $0.8 million, or 10.0%, to $9.3 million for the year ended December 31, 2023, from $8.5 million for the year ended December 31, 2022[354] - Operating losses for the year ended December 31, 2023, were approximately $9.5 million, with an accumulated deficit of approximately $24.7 million as of December 31, 2023[355] Cash Flow - Cash used in operating activities for the year ended December 31, 2023, was $7.3 million, compared to $6.6 million for the year ended December 31, 2022[361] - Cash provided by financing activities for the year ended December 31, 2023, was $11.7 million, compared to $13.1 million for the year ended December 31, 2022[363] - The company received gross proceeds of approximately $13.6 million through public offerings of common stock on May 2, 2023, and November 30, 2023[355] - The company will need substantial additional funding to support future operating activities, raising substantial doubt about its ability to continue as a going concern for at least one year[357]

Revenue Recognition - Tharimmune did not recognize any revenues for the three and nine months ended September 30, 2023 and 2022[123]. Research and Development Expenses - Research and development expenses decreased by $343,667, or 41.3%, to $488,177 for the three months ended September 30, 2023, primarily due to the deprioritization of HSB-1216[135]. - Research and development expenses increased by $971,691, or 60.9%, to $2,566,910 for the nine months ended September 30, 2023, from $1,595,219 for the same period in 2022, driven by pre-clinical activities and stock-based compensation[142]. - Tharimmune expects an increase in research and development expenses as it prepares for clinical trials of TH3215 and TH1940[126]. - The company has deprioritized HSB-1216 to focus on therapeutics for high unmet need cancers[117]. General and Administrative Expenses - General and administrative expenses increased by $61,251, or 4.7%, to $1,356,893 for the three months ended September 30, 2023, driven by higher investor relations and legal expenses[136]. - General and administrative expenses rose by $836,873, or 23.8%, to $4,357,154 for the nine months ended September 30, 2023, from $3,520,281 for the same period in 2022, primarily due to increased investor relations and legal expenses[143]. Operating Expenses and Losses - Total operating expenses decreased by $282,416 to $1,845,070 for the three months ended September 30, 2023[134]. - The net loss for the three months ended September 30, 2023, was $1,820,115, a decrease of $307,371 compared to the same period in 2022[134]. - Net loss decreased by $307,371, or 14.4%, to $1,820,115 for the three months ended September 30, 2023, from $2,127,486 for the same period in 2022, attributed to a decrease in research and development expenses[139]. - The company incurred operating losses of approximately $6.9 million for the nine months ended September 30, 2023, with an accumulated deficit of approximately $22.2 million as of the same date[147]. - The company reported a net loss increase of $138,573, or 2.1%, to $6,845,317 for the nine months ended September 30, 2023, from $6,706,744 for the same period in 2022, due to rising research and development and general administrative expenses[146]. Cash Flow - Net cash used in operating activities was $5,884,679 for the nine months ended September 30, 2023, compared to $5,665,274 for the same period in 2022[151]. Financing and Agreements - Tharimmune entered into a patent license agreement with Avior Inc. on November 3, 2023, for the commercialization of TH104 and TH103, involving mid six-digit upfront fees and milestone payments totaling $24,250,000[122]. - Tharimmune issued $250,000 worth of common stock to ABSI as part of a research and development collaboration agreement[121]. - The company raised approximately $2.1 million from a public offering of common stock on May 2, 2023, following net proceeds of approximately $13.0 million from its IPO on January 14, 2022[147]. Interest Income and Expense - Interest expense increased by $3,496, or 100.0%, to $3,496 for the three months ended September 30, 2023, from $0 for the same period in 2022, primarily due to insurance premium financing liability[137]. - Interest income increased by $28,451, or 100.0%, to $28,451 for the three months ended September 30, 2023, from $0 for the same period in 2022, mainly from funds held in cash accounts[138]. Going Concern - The company expressed substantial doubt about its ability to continue as a going concern for at least one year following the issuance of its financial statements, highlighting ongoing liquidity risks[148].

Product Development - Hillstream BioPharma is developing novel therapeutic candidates targeting high-value immuno-oncology targets including HER2, HER3, and PD-1, with plans to advance HSB-3215 into IND-enabling studies in 2024[117] - The company anticipates that HSB-0059, a HER2/HER3 bispecific ADC, and HSB-1940, a PD-1 Picobody, will also progress to IND-enabling studies in 2024[117] - Hillstream BioPharma has entered into a research collaboration and product license agreement with Minotaur Therapeutics and a commercial license agreement with Taurus Biosciences to develop targeted biologics against PD-1[125] - The company has extended its collaboration agreement in July 2023 to include an additional target (HER3) and an oncology target[126] - The impact of the COVID-19 pandemic on the company's operations and clinical development timelines remains uncertain[128] Financial Performance - Hillstream BioPharma has not recognized any revenue for the three months ended June 30, 2023, and 2022[130] - Research and development expenses are expected to increase as the company plans to commence clinical trials for HSB-3215 and HSB-1940[133] - General and administrative expenses primarily consist of compensation, consulting, and professional fees, which are essential for corporate operations[136] - Research and development expenses increased by $575,510, or 126.3%, to $1,031,056 for the three months ended June 30, 2023, compared to $455,546 for the same period in 2022[141] - General and administrative expenses rose by $152,232, or 12.9%, to $1,333,540 for the three months ended June 30, 2023, from $1,181,308 in the prior year[142] - Total operating expenses for the three months ended June 30, 2023, were $2,364,596, an increase of $727,742 from $1,636,854 in the same period of 2022[140] - Net loss for the three months ended June 30, 2023, was $2,336,914, compared to a net loss of $1,636,854 for the same period in 2022, reflecting an increase of $700,060[140] - For the six months ended June 30, 2023, research and development expenses increased by $1,315,358, or 172.3%, to $2,078,733 from $763,375 in the same period of 2022[146] - General and administrative expenses for the six months ended June 30, 2023, increased by $775,622, or 34.9%, to $3,000,261 from $2,224,639 in the prior year[147] - Interest income for the six months ended June 30, 2023, was $66,447, a 100.0% increase from $0 in the same period of 2022[149] - The company incurred operating losses of approximately $5.1 million for the six months ended June 30, 2023, with an accumulated deficit of approximately $20.4 million as of the same date[151] - Cash used in operating activities for the six months ended June 30, 2023, was $4,975,713, compared to $4,116,342 for the same period in 2022[155] - The company closed a public offering of shares on May 2, 2023, generating net proceeds of approximately $2.1 million[151] Accounting and Compliance - Stock-based compensation costs are recognized over the requisite service period based on the estimated fair value of the awards[165] - The fair value of stock options is estimated using the Black-Scholes option-pricing model, with an expected term of five to seven years[167] - The company has chosen to take advantage of the extended transition periods under the JOBS Act for complying with new accounting standards[170] - The company will remain an "emerging growth company" until total annual gross revenues reach $1.235 billion or more[171] - The company is not required to provide market risk disclosures as it qualifies as a "smaller reporting company"[172]

Product Development - Hillstream BioPharma's most advanced product candidate, HSB-1216, targets treatment-resistant solid tumors and aims to submit an IND to the FDA in late 2023 or early 2024 [101]. - Hillstream BioPharma is developing HSB-1940, a combination of PD-1 targeting Picobodies bound to Quatramers, to enhance targeting of "undruggable" epitopes [104]. - The company has entered into a collaboration agreement with Minotaur Therapeutics for the development of biologics targeting PD-1 [113]. - Hillstream BioPharma's Quatramer platform aims to improve drug delivery to the tumor microenvironment while minimizing off-target toxicity [103]. - The company is actively seeking collaborations with leading pharmaceutical companies to develop Quatramer-based therapeutics [109]. Financial Performance - The company did not recognize any revenues for the three months ended March 31, 2023 and 2022 [119]. - Research and development expenses increased by $739,848, or 240.3%, to $1,047,677 for the three months ended March 31, 2023, compared to $307,829 for the same period in 2022 [132]. - General and administrative expenses rose by $623,390, or 59.7%, to $1,666,721 for the three months ended March 31, 2023, from $1,043,331 in the prior year [133]. - Interest expense decreased by $1,585,106, or 100.0%, to $6,138 for the three months ended March 31, 2023, from $1,591,244 for the same period in 2022 [134]. - Interest income increased by $32,248, or 100.0%, to $32,248 for the three months ended March 31, 2023, from $0 in the prior year [135]. - The company incurred operating losses of approximately $2.7 million and had an accumulated deficit of approximately $18.1 million as of March 31, 2023 [136]. Cash Flow and Funding - Cash used in operating activities was $3,464,690 for the three months ended March 31, 2023, compared to $2,728,315 for the same period in 2022 [141]. - Cash provided by financing activities was $523,364 for the three months ended March 31, 2023, significantly lower than $13,845,813 in the prior year [144]. - The company closed a public offering on May 2, 2023, issuing 5,300,000 shares at $0.50 per share, resulting in net proceeds of approximately $2.2 million [117]. - The company will need substantial additional funding to support future operating activities due to recurring negative cash flows [137]. - The company may seek to raise additional funding through equity or debt securities, strategic partnerships, or grants, but there is no assurance of obtaining sufficient capital [138]. Operational Challenges - Research and development expenses are expected to increase as the company plans to commence clinical trials for HSB-1216, HSB-3215, and HSB-1940 [123]. - General and administrative expenses are expected to rise as the company increases personnel to support research and development activities [127]. - The impact of the COVID-19 pandemic on the company's operations and clinical development timelines remains uncertain [118].