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, today announced a collaboration with Sapien Biosciences to evaluate the synergy of HSB-1216 with immune checkpoint inhibitors.

Immune Checkpoint Inhibitors and Ferroptosis

Treatment with immune checkpoint inhibitors (ICIs) induces the effector function of T cells in the tumor microenvironment (TME). Activated T cells accumulated in TME then kill tumor cells mainly by enhancing cell death through the granzyme pathway and by releasing interferon gamma (IFN) from CD8+ T cells. Ferroptosis is a newly defined form of cell death, that is different than apoptosis, necrosis or autophagy, and results from iron-dependent accumulation of lipid reactive oxygen species or lipid peroxidation.

Recent studies published [Nature, 569 (7755):270-274, 2019] describe that immunotherapy-activated CD8+ T cells enhance ferroptosis-specific lipid peroxidation in tumor cells leading to the anti-tumor effect of immunotherapy. Activated CD8+ T cells by treatment with ICIs promote tumor cell lipid peroxidation and thereby sensitize tumor cells to ferroptosis inducers through IFN. The study concluded that inducing the Ferroptotic pathway in combination with checkpoint blockade is a potential synergistic therapeutic approach.

“We are initiating studies, in collaboration with Sapien Biosciences, to determine the synergy between HSB-1216, our ferroptosis inducer and nivolumab, an anti-PD1 antibody,” said Randy Milby, Hillstream’s Chief Executive Officer. “In addition, we will also study the potential synergistic effects of HSB-1216 with the recently approved Bristol Myers Squibb drug Opdualag® (nivolumab + relatlimab), a fixed dose combination of an anti-PD1 MAb + anti-LAG3 MAb, to demonstrate that targeting a ferroptosis-associated metabolism in tumors may improve the efficacy of cancer immunotherapy.”

“We are excited to extend our collaboration with Hillstream Biopharma to evaluate potential synergy between their HSB-1216 molecule and ICIs using our expertise in establishing patient tissue-derived cell models in oncology, immunology and Immune-oncology,” said Dr. Jugnu Jain, CEO, Sapien Biosciences. “Previously, Sapien demonstrated potent anti-cancer activity of HSB-1216 in primary triple negative breast cancer cells which were presented at AACR 2020.”

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.

About Sapien Biosciences Private Limited

Sapien Biosciences, founded in 2012 and headquartered in India, is a joint venture between Apollo Hospitals and Saarum Innovations that has created one of the 10- largest multi-disease biobanks in the world. Sapien uses its patient samples and rich datasets to help biotech companies validate novel drug targets, drugs and diagnostics that translate into better clinical outcomes. Sapien’s trademarked services and products include 1) OncoblocTM, a systematic collection of pathology blocks with complete demographic and diagnostic data, 2) OncoPrimeTM, a panel of primary cells derived from cancer patient tissues, cultured as 2D or 3D spheres to test novel drugs, 3) TruCellTM, a panel of primary cells derived from all types of normal or disease samples such as cancer-associated fibroblasts, dendritic cells, 4) TruSkinTM , cell & molecular assays using normal human skin to test novel formulations and drugs, 5) TruDataTM , real world treatment and outcomes data of Indian cancer patients including genotype data, and 6) Clinical diagnostics that are developed at Sapien or with partners to personalize therapy. For more information, please visit: https://sapienbio.co.in/

Forward Looking StatementsCertain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Hillstream’s expectations, strategy, plans or intentions. These forward-looking statements are based on Hillstream’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Investors should read the risk factors set forth in our Form 10-K for the year ended December 31, 2021 and our periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Hillstream does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Relations Contact:Email: investorrelations@hillstreambio.comwww.hillstreambio.com

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