HSB-3215

Anticipate completion of Phase 1 & Phase 2 clinical trials in chronic pruritis over the next approximately 12 months Seeking first approval in an orphan disease, PBC, for the treatment of moderate to severe chronic pruritis in which more than 70% of patients suffer from chronic pruritis BRIDGEWATER, N.J., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Hillstream BioPharma, Inc. (Nasdaq: HILS) ("Hillstream" or the "Company"), a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancer announces an exclusive option agreement to acquire a clinical stage asset, AV104, with a recently approved IND. AV104 has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritis or “uncontrollable itching”. The Company intends to first seek approval in an orphan disease for the treatment of moderate to severe cholestatic pruritis in patients with primary biliary cholangitis (PBC), a rare form of liver disease with no known cure in which more than 70% of patients suffer from chronic pruritis. Embedded onto a proprietary transdermal buccal film which easily adheres to the inside of the mouth, AV104’s key features make it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. AV104’s active molecule, nalmefene, has a dual mechanism of action by affecting both the µ-opioid receptor and the kappa opioid receptor as well as inhibiting IL-17 inflammatory cytokine expression. These opioid receptors when stimulated and/or inhibited by the body’s natural ligands have been known to be involved in the body’s itch circuitry. When the itch circuitry is imbalanced in diseased conditions, pharmacological intervention can help suppress this phenomenon which occurs in patients suffering from chronic pruritis. Nalmefene crosses into the circulation via a proprietary buccal delivery by adhering the drug-coated film inside the cheek where the film biodegrades in minutes and the drug is absorbed. The buccal delivery of the drug bypasses the liver’s first-pass metabolism thus creating high drug concentrations in the skin, an added benefit for treating conditions in which the liver may be impaired. The Company intends to complete a bridging pharmacokinetic phase 1 trial and a phase 2 proof-of-concept in PBC patients over approximately the next 12 months after alignment with the US FDA. Hillstream believes AV104 has expansion opportunities in treating chronic pruritogenic conditions associated with cholestatic liver disease as well as other liver related and as non-liver related diseases including fatty and alcoholic liver diseases, non-alcoholic liver diseases and certain types of hepatitis. Chronic pruritis is significant in liver diseases as well as chronic kidney diseases, hemodialysis and atopic dermatitis. “The past year has been a period of transformational change for our company,” said Randy Milby, CEO of Hillstream. “This exclusive option allows the company to bring a clinical-stage asset into the organization as we shift into a patient-focused biotechnology organization. This signifies our next step as we grow into a business model focused on clinical development.” Webcast details Hillstream BioPharma will host a webcast on Monday September 11th at 4:30 pm ET to describe this opportunity in more detail. Participant Dial-In: 877-407-8835 / +1 201-689-8779. Click here for participant International Toll-Free access numbers Webcast: https://event.webcasts.com/starthere.jsp?ei=1633694&tp_key=3823baed9e Callme™: https://hd.choruscall.com/InComm/?callme=true&passcode=13741139&h=true&info=company-email-jobtitle&r=true&B=6 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’s emerging immuno-oncology pipeline is led by HSB-3215, a novel anti-HER2/HER3 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. Hillstream has a license agreement with OmniAb, Inc. to access the company’s antibody discovery technology platform against specified targets. For more information, please visit: www.hillstreambio.com. 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, 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. “Picobody” is a trademark of Crystal Bioscience, Inc., a unit of OmniAb, Inc. Investor Relations ContactEmail: investorrelations@hillstreambio.comwww.hillstreambio.com