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

Licensing and Collaborations - Tharimmune entered into a patent license agreement with Avior Inc. on November 3, 2023, paying an upfront license fee of $0.4 million and a quarterly fee of $0.15 million for 2024[107][114] - Tharimmune licensed INT-023/TH023, an oral anti-TNF-α monoclonal antibody, from Intract Pharma Limited, receiving a mid-six digit upfront payment and potential mid-single digit royalties based on net sales[108][116] - The Avior agreement includes milestone payments totaling $24.25 million upon achieving various development milestones[114] - The company aims to pursue strategic collaborations and potential mergers to enhance the value of its pipeline[112] Product Development - The FDA approved an IND application for TH104 in February 2023, targeting moderate-to-severe chronic pruritus in patients with primary biliary cholangitis, with topline data expected in Q4 2025[107] - The company plans to develop TH104 as a buccal film product for both chronic pruritus and temporary prophylaxis of respiratory depression in military personnel[112] - Tharimmune anticipates advancing HS3215, a HER2/HER3 bispecific antibody, into preclinical studies in 2025[110] - The company received positive FDA feedback on a regulatory pathway for TH104's additional indication for opioid exposure prophylaxis, requiring only nonclinical studies before NDA submission[107] - Tharimmune's strategy includes a capital-efficient approach to meet FDA requirements for filing an NDA for TH104[107] - The company plans to delay the Phase 2 trial of TH104 in chronic pruritus patients until after completing a hepatic impairment study, following positive FDA feedback[121] Financial Performance - The company incurred a net loss of $2,541,704 for the three months ended March 31, 2025, compared to a net loss of $2,256,109 for the same period in 2024[134] - Net cash used in operating activities was $2,689,001 for the three months ended March 31, 2025, compared to $2,825,181 for the same period in 2024[144] - Research and development expenses decreased by $431,188, or 42%, to $594,070 for the three months ended March 31, 2025, primarily due to reduced clinical trial expenses[135] - General and administrative expenses increased by $630,554, or 43%, to $1,952,599 for the three months ended March 31, 2025, driven by higher investor relations and corporate tax expenses[136] - Interest expense rose by $3,771, or 80%, to $8,471 for the three months ended March 31, 2025, mainly due to insurance premium financing liabilities[137] - Interest income decreased by $82,458, or 86%, to $13,436 for the three months ended March 31, 2025, attributed to a decline in cash reserves[138] - The accumulated deficit was approximately $39.4 million as of March 31, 2025, indicating ongoing financial challenges[139] - The company raised gross proceeds of $0.26 million in April 2025 from the sale of 160,817 shares at an average price of $1.61 per share[140] Accounting and Reporting - Management estimates for financial statements are based on historical experience and reasonable assumptions, affecting reported amounts of assets, liabilities, revenue, and expenses[151] - Research and development costs are expensed as incurred, including personnel costs and third-party contractor expenses, with accruals based on estimates of services performed[152] - Stock-based compensation costs are measured at grant date using the Black-Scholes model, with fair value amortized over the requisite service period[154] - The expected term of stock options granted ranges from five to seven years, with risk-free interest rates based on the U.S. Treasury yield curve[155] - The company has chosen to take advantage of extended transition periods under the JOBS Act for complying with new accounting standards, which may affect comparability with other public companies[158] - As an "emerging growth company," the company intends to rely on certain exemptions, including not providing an auditor's attestation report on internal controls until certain conditions are met[159] - The company is classified as a "smaller reporting company" and is not required to provide specific market risk disclosures[160] Clinical Trial Results - The Phase 1 clinical trial of TH104 showed an absolute bioavailability (F) of 45.9% compared to intravenous nalmefene, with a median time to maximum concentration (Cmax) of 2.0 hours and a mean half-life (T1/2) of 14 hours[120]

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].