BRIDGEWATER, N.J., April 13, 2023 (GLOBE NEWSWIRE) -- Hillstream BioPharma, Inc. (Nasdaq: HILS) ("Hillstream" or the "Company"), a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancers using ferroptosis, an emerging new anti-cancer mechanism resulting in iron-mediated cell death, and immuno-oncology targeted novel biologics, has selected immune-oncology clinical research organization (CRO), OncoBay Clinical, to provide comprehensive clinical and regulatory support for the clinical development program for its lead drug candidate HSB-1216.

HSB-1216, Hillstream’s most advanced candidate, utilizes ferroptosis, an emerging new anti-cancer mechanism resulting in iron-mediated cell death (IMCD) of drug-resistant cancers. As part of the agreement, OncoBay Clinical’s engagement will provide comprehensive clinical expertise across data management, statistical programming, scientific writing, regulatory affairs and clinical operations services for clinical, and observational studies. Additionally, OncoBay will leverage the support of a multitude of top scientific advisors and highly experienced teams to support Hillstream.

“OncoBay is a natural partner for us, complementing the oncological expertise of our team,” said Randy Milby, CEO of Hillstream BioPharma. “With their experience managing the complexity of oncological research programs and scientific support from the Moffitt Cancer Center, we believe that the team at OncoBay is uniquely positioned to support the advancement of the HSB-1216 development program.”

“We are excited to be partnering with Hillstream BioPharma on the development of HSB-1216,” said Krystyna Kowalczyk, President and CEO of OncoBay Clinical. “We are confident that our proven ability to succeed in managing the complexities of oncological research will enable the accelerated development of Hillstream’s HSB-1216 program and ultimately make an impact on patients.”

About OncoBay Clinical

OncoBay Clinical is a global boutique contract research organization (CRO) specializing in immuno- oncology/cell therapy and other complex oncology programs. OncoBay offers strategic and full- service custom-curated solutions for global pharmaceutical and biotech companies looking to advance their product or device. Originated from Moffitt Cancer Center, OncoBay embeds scientific expertise, operational excellence and integration of technology including AI analytics to drive quality and data integrity. Built on years of oncology expertise, an advanced technology framework, a highly aligned site network, and a skilled team of experienced professionals, OncoBay is committed to operational excellence from start to finish. For more information, visit Oncobay.com and follow us on Facebook, Twitter and LinkedIn.

About Hillstream BioPharma, Inc.

Hillstream BioPharma, Inc. is a biotechnology company developing a focused portfolio of therapeutic candidates targeting drug resistant and devastating cancers. The Company anticipates submitting an investigational new drug application and plans to initiate a clinical study in the second half of 2023 with HSB-1216, which targets ferroptosis, an emerging new anti-cancer mechanism, resulting in iron mediated cell death (IMCD) of drug resistant cancers. The Company’s emerging immuno-oncology pipeline is led by HSB-3215, a novel anti-HER2 monoclonal antibody targeting unique epitopes with a novel mechanism of action. The erbB/HER family of cell surface proteins include well-known and validated drug targets including HER2 and HER3 found in multiple solid tumors, including breast, lung, GYN, endocrinological and CNS. For more information, please visit: www.hillstreambio.com.

Forward Looking Statements

Certain 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, 2022 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.

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