Financial Performance - The company did not recognize any revenues for the three and nine months ended September 30, 2022 and 2021[112]. - The company incurred net losses of approximately $6.7 million for the nine months ended September 30, 2022, compared to $4.7 million for the same period in 2021[133]. - The company has not yet commercialized any products and has never generated revenue from product sales[133]. Expenses - Hillstream BioPharma's research and development expenses increased by $518,711, or 165.7%, to $831,844 for the three months ended September 30, 2022, compared to $313,133 for the same period in 2021[124]. - General and administrative expenses rose by $1,067,662, or 468.3%, to $1,295,642 for the three months ended September 30, 2022, from $227,980 for the same period in 2021[125]. - Research and development expenses decreased by $288,589, or 15.3%, to $1,595,219 for the nine months ended September 30, 2022, from $1,883,808 for the same period in 2021[129]. - General and administrative expenses increased by $2,297,665, or 187.9%, to $3,520,281 for the nine months ended September 30, 2022, from $1,222,616 for the same period in 2021[130]. - Interest expense increased by $1,018,332, or 177.7%, to $1,591,244 for the nine months ended September 30, 2022, from $572,912 for the same period in 2021[131]. Cash Flow and Financing - As of September 30, 2022, the company had approximately $7.6 million in cash and working capital of approximately $7.1 million, with an accumulated deficit of approximately $13.6 million[133]. - Net cash used in operating activities was approximately $5.5 million for the nine months ended September 30, 2022, compared to $1.1 million for the same period in 2021[136]. - Cash provided by financing activities for the nine months ended September 30, 2022, was $13,086,591, significantly higher than $931,812 for the same period in 2021[140]. - Additional funding will be necessary to support future clinical and pre-clinical activities, with no assurance of obtaining adequate financing[134]. Clinical Development - The company plans to submit an IND application for HSB-1216 to the FDA in 2023 and anticipates initial clinical data by the end of 2023 or early 2024[102]. - HSB-888 is in IND-enabling trials with the goal of submitting an IND to the FDA in 2024[106]. - The company aims to develop and commercialize Quatramer in collaboration with leading pharmaceutical companies[107]. - The proprietary Quatramer platform is designed to enhance drug delivery directly to the tumor microenvironment while minimizing off-target toxicity[104]. - The ongoing impact of the COVID-19 pandemic on the company's operations and clinical development timelines remains uncertain[111]. Debt and Accounting - Interest expense decreased by $235,822, or 100.0%, to $0 for the three months ended September 30, 2022, due to the conversion of debt into common stock upon the closing of the IPO[126]. - The change in redemption value decreased by $76,501, or 100.0%, to $0 for the three months ended September 30, 2022, as the redemption liability was re-evaluated following the IPO[127]. - The change in redemption value decreased by $980,245, or 100.0%, to $0 for the nine months ended September 30, 2022, from $980,245 for the same period in 2021[132]. - The initial fair value of the redemption feature related to convertible debt instruments was treated as a debt discount and amortized over the term of the related debt[158]. - The unamortized debt discount at December 31, 2021, was presented as a direct deduction from the carrying amount of the related debt[158]. - The company accounts for derivative instruments in accordance with FASB ASC 815, recognizing all derivatives on the balance sheet at fair value[159]. - The company intends to rely on exemptions provided under the JOBS Act, including delaying the adoption of certain accounting standards[163]. - The company will remain an "emerging growth company" until it meets specific revenue or debt issuance thresholds[163]. Shareholder Actions - The Board of Directors has authorized the repurchase of up to $1 million of shares of common stock[154].
Tharimmune(THAR) - 2022 Q3 - Quarterly Report