Drug Development - Hillstream BioPharma is developing HSB-1216, an IMCD inducer targeting solid tumors, with clinical data expected to be released in late 2024 or early 2025[426]. - The company aims to submit an IND to the FDA for HSB-1216 in the second half of 2023, although acceptance is not guaranteed[426]. - Research and development expenses are expected to increase as the company plans to commence clinical trials for HSB-1216, HSB-3215, and HSB-1940[449]. - The company is leveraging its Quatramer platform to develop a pipeline of high-value drug candidates targeting solid tumors and drug-resistant cancers[434]. - Hillstream has entered into a collaboration agreement with Minotaur and a license agreement with Taurus to advance Picobodies against PD-1[439]. - The development of HSB-1940 aims to target "undruggable" epitopes with a combination of Quatramers and Picobodies[429]. Financial Performance - Hillstream has not recognized any revenue for the years ended December 31, 2022, and 2021[445]. - Research and development expenses increased by $435,621, or 23.6%, to $2,278,424 for the year ended December 31, 2022 from $1,842,803 for the year ended December 31, 2021[460]. - General and administrative expenses increased by $3,238,300 or 237.2%, to $4,603,514 for the year ended December 31, 2022 from $1,365,214 for the year ended December 31, 2021[462]. - Interest expense increased by $759,967, or 91.4%, to $1,591,244 for the year ended December 31, 2022 from $831,277 for the year ended December 31, 2021[463]. - The company incurred operating losses of approximately $6.9 million for the year ended December 31, 2022, with an accumulated deficit of approximately $15.4 million as of December 31, 2022[465]. - Net cash used in operating activities was $6,557,950 for the year ended December 31, 2022, compared to $1,086,244 for the year ended December 31, 2021[469]. - Net cash provided by financing activities was $13,064,128 for the year ended December 31, 2022, primarily from the issuance of common stock in connection with the IPO[472]. - The company raised approximately $13.0 million in net proceeds from the IPO, which began trading on The Nasdaq Capital Market on January 12, 2022[465]. - The change in redemption value decreased by $1,832,651, or 100.0%, to $0 for the year ended December 31, 2022 from $1,832,651 for the year ended December 31, 2021[464]. - The company will need substantial additional funding to support future operating activities due to recurring negative cash flows[467]. - The company may seek to raise additional funding through the sale of equity or debt securities, strategic partnerships, or grants[467]. Accounting and Compliance - The company accounts for derivative instruments in accordance with ASC 815, recognizing all derivatives on the balance sheet at fair value[490]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of certain accounting standards until they apply to private companies[492]. - The company will remain an emerging growth company until it has total annual gross revenues of $1.235 billion or more during a fiscal year[492]. Operational Challenges - The impact of the COVID-19 pandemic on the company's operations and clinical development timelines remains uncertain[444]. - General and administrative expenses are expected to rise as the company increases personnel to support research and development activities[453].
Tharimmune(THAR) - 2022 Q4 - Annual Report