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].

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].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Exact Name of Registrant as Specified in its Charter) Commission File Number: 001-41210 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 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 ___________ HILLSTREAM BIOPHARMA, INC. (State or other ...

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 ...