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].

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].

FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to ___________ Commission File Number: 001-41210 HILLSTREAM BIOPHARMA, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 84-2642541 ( ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to ___________ Commission File Number: 001-41210 HILLSTREAM BIOPHARMA, INC. Securities registered pursuant to Section 12(b) of the Act: (Exact Name of ...

FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to _________ Commission file number 001-41210 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 HILLSTREAM BIOPHARMA, INC. (Exact name of registrant as specified in charter) | Delaware | 84-2642541 | | --- | --- | | (S ...