Hillstream BioPharma R&D Day Highlights Ferroptosis, the Non-Genetic Novel, Emerging Mechanism of Action, Targeting Drug Resistant and Devastating Cancers

• HSB-1216’s active moietyin clinical pilot study produced a 71% response rate in TNBC and epithelial carcinomas
• HSB-1216 was recently granted Orphan Drug Designation to treat Uveal Melanoma by the FDA
• Rare Pediatric Disease (RPD) Designation and Orphan Drug Designationwas granted to HSB-888’s active moiety for pediatric osteosarcoma by the FDA
• Replay of R&D Day webcast available on Hillstream’s IR site

BRIDGEWATER, NJ, March 02, 2022 (GLOBE NEWSWIRE) -- Hillstream BioPharma, Inc. (NASDAQ: HILS) ("Hillstream" or the "Company"), a biotechnology company developing novel therapeutic candidates targeting ferroptosis, an emerging new anti-cancer mechanism resulting in iron mediated cell death for drug resistant and devastating cancers, provided a webcast replay of the Company’s R&D Day held on February 24, 2022.

The event was held virtually for invited investors and guests.

The following Scientific Advisory Board (SAB) members delivered prepared remarks and discussed the Company’s R&D strategy, emerging pipeline assets, and anticipated milestones:

"Drug resistance and metastasis are the biggest challenges in cancer treatments today," said Donald Kufe, M.D. "By targeting Ferroptosis, an emerging new mechanism targeting drug-resistant cancers, we’ve seen immensely encouraging progress targeting drug resistant cancers. We proudly shared our progress at our R&D Day, notably our leading drug candidate ​​HSB-1216. With encouraging efficacy data in an early clinical study and recent FDA orphan drug designation to treat Uveal Melanoma, our mission has never been clearer. We invite and encourage our shareholders and prospective investors to watch our R&D Day webcast replay, which we have now made available.”

HSB-1216 targets solid tumors as a ferroptosis-inducing agent and novel investigational treatment. The active in a clinical pilot study showed a 71% response rate and efficacy against devastating cancers, including triple-negative breast cancer and epithelial carcinomas. HSB-1216 has orphan drug designation (ODD) for small cell lung cancer, and recently received ODD for Uveal Melanoma (UM).

The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

Uveal Melanoma is the most common primary intraocular tumor and accounts for 85% to 95% of primary ocular malignancies and 3% to 5% of all melanoma cases. Approximately 50% of patients with UM manifest distant organ metastasis, predominantly to the life-sustaining organs such as the liver, even after removal of primary tumors. Hillstream is rapidly progressing towards an IND filing process and plans to initiate a clinical trial in solid tumor patients.

HSB-888, Hillstream’s second product candidate is a Quatramer dual loaded with IMCD inducer coupled with our ultra-low dose, next generation anthracycline analogue for solid tumors. HSB-888 has demonstrated highly synergistic tumor killing capacity in a TNBC cell line. HSB-888’s active moiety has received FDA’s Rare Pediatric Disease Designation and Orphan Drug Designation for pediatric osteosarcoma.

Hillstream’s R&D Day can be accessed via Hillstream’s IR site.

About Hillstream BioPharma Inc.

Hillstream BioPharma, Inc. is a biotechnology company developing novel therapeutic candidates targeting ferroptosis, an emerging new anti-cancer mechanism resulting in iron mediated cell death for drug resistant and devastating cancers. Hillstream's most advanced candidate is HSB-1216, an IMCD modulator, targeting a variety of solid tumors. The active drug in HSB-1216 was found to be efficacious in a clinical pilot study in Germany in devastating cancers, including triple negative breast cancer and epithelial carcinomas. Hillstream intends to start a clinical study with HSB-1216 in 2022 to expand upon the existing early clinical proof-of-concept. Hillstream uses Quatramer™, our proprietary tumor targeting platform, to enhance the uptake of HSB-1216 in the tumor microenvironment with an extended duration of action and minimal off-target toxicity. In addition, Trident Artificial Intelligence, Hillstream's artificial intelligence precision medicine platform, is used to identify biomarkers in our clinical programs to target a specific patient segment most likely to benefit. For more information, please visit www.hillstreambio.com.

Forward Looking Statements

This press release includes forward-looking statements including, but not limited to, statements related to the expected use of proceeds from the offering. The forward-looking statements contained in this press release are based on management's current expectations and are subject to substantial risks, uncertainty and changes in circumstances. Actual results may differ materially from those expressed by these expectations due to risks and uncertainties, including, among others, those related to the Company's ability to obtain additional capital on favorable terms to it, or at all, including, without limitation, to fund its current and future preclinical studies and clinical trials and the success, timing and cost of its drug development program and its ongoing or future preclinical studies and clinical trials, including, without limitation, the possibility of unfavorable new clinical and preclinical data and additional analyses of existing data, that the risks that prior clinical and preclinical results may not be replicated, and risks associated with the current coronavirus pandemic. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to review or update any forward-looking statement except as may be required by applicable law.

Investor Relations Contact:

Email: investorrelations@hillstreambio.com
www.hillstreambio.com

SOURCE: Hillstream BioPharma Inc.