Hillstream BioPharma Provides Business Review with Key Pipeline Updates

Rhea-AI Summary

Hillstream BioPharma (NASDAQ:HILS) announced key updates in its pipeline and a successful $15 million IPO on January 14, 2022. The company is advancing HSB-1216, a novel ferroptosis inducer targeting drug-resistant cancers, with promising results in non-clinical studies. The FDA granted orphan drug designation for HSB-1216 for small cell lung cancer, offering seven years of market exclusivity. Hillstream is also exploring additional indications and leveraging its proprietary Quatramer tumor-targeting platform for enhanced delivery of therapeutics.

Positive

• Successful $15 million IPO on January 14, 2022.
• Favorable FDA orphan drug designation for HSB-1216 in small cell lung cancer.
• Promising early efficacy data for HSB-1216 from studies in Germany.
• Expansive pipeline with ongoing research into multiple solid tumors.

Negative

• Long and uncertain clinical trial process may delay product approvals.
• Dependence on third parties and potential competition in the market.

Continued development and validation of HSB-1216 as a leading Ferroptosis inducer to enter the clinic

Successful Closing of a $15 million Initial Public Offering on January 14, 2022

R&D Day to Review Novel Emerging Pipeline on February 24, 2022

BRIDGEWATER, NJ / ACCESSWIRE / February 14, 2022 / Hillstream BioPharma, Inc. (NASDAQ:HILS) ("Hillstream", 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 business review along with key pipeline updates.

"We have made tremendous progress at Hillstream over the past year culminating in our successful $15 million IPO with a NASDAQ listing a month ago," stated Randy Milby, Hillstream's Chief Executive Officer, "Our deep roots in scientific innovation and discovery over the past decade, has allowed us to build tailor-made multi-omics ferroptotic datasets across multiple oncologic diseases to power discovery campaigns which leverage our Quatramer™ tumor-targeting platform thus bringing unprecedented therapeutics to patients suffering from devastating cancers."

HSB-1216

• Emerging novel mechanism of action, Ferroptosis/IMCD (Iron mediated cell death) with human proof-of-concept study showing promising efficacy in multiple solid tumors from the University of Heidelberg, Germany
• Non-clinical research using HSB-1216 in the unmet need indications of platinum-resistant small cell lung cancer as a single agent and in combination with doxorubicin in TNBC (triple negative breast cancer). 2021 American Association for Cancer Research (AACR) Abstract Number 3107: HSB-1216 A Novel Agent for the Treatment of Chemotherapy-Resistant ES-Small Cell Lung Cancer; and Abstract Number 3082: Synergistic Inhibition of TNBC cell growth by novel doxorubicin/salinomycin - encapsulated dual drug nanoparticles
• Continuing to explore additional indications including NSCLC (Non-small cell lung cancer) and AML (acute myeloid leukemia)
• The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to HSB-1216 for the treatment of small cell lung cancer. The ODD designation provides seven years of market exclusivity post approval.
• AACR E-poster Number 492- (Abstract 803) in 2020 A Novel QUATRA Acquisition of a ferroptosis inducer portfolio with related global patents, non-clinical data, other filings and know-how. The licensed products are various novel small molecules with increased efficacy against a sub-group of solid tumors including breast, pancreatic and prostate. The increased potency of these compounds along with a wider therapeutic index makes them attractive as backups to HSB-1216.
• AACR E-Poster Number 491 - (Abstract 738) in 2020 - Encapsulation of the stem cell inhibitor Salinomycin in novel QUATRAMER sustained injectable suspension (HSB-1216) for the treatment of small cell lung cancer
• AACR Abstract Number 3107 in 2021: HSB-1216 A Novel Agent for the Treatment of Chemotherapy-Resistant ES-Small Cell Lung Cancer
• Continuing IND enabling studies to launch human studies last in 2022

QUATRAMER™ Tumor Targeting Platform

• Novel tumor targeting platform for small molecules, biologics (including ADNCs, ADCs and scFv's)
• QUATRAMER is our key platform, poised to enter the Immuno-oncology (IO) space with a novel technology that we believe may provide a non-viral tumor specific delivery vehicle of cytokines with high efficacy in tumors with too narrow a therapeutic index for clinical feasibility, including TNF-alpha and others
• Collaboration with the Ardena Group, a world-class Contract Development and Manufacturing Organization (CDMO to secure manufacturing feasibility and capacity for QUATRAMER portfolio. The Ardena Group aligns with our strategy of partnering with the best collaborators.

World-Class Scientific Advisory Board

• Expansion of our Scientific Advisory Board (SAB) with the addition of Scott J. Dixon, Ph.D., Associate Professor, Biology, Stanford University and Faculty Fellow of Stanford's ChEM-H initiative and Member, Stanford Cancer Institute.
• Chairman of the SAB: Donald Kufe, M.D.: Professor Distinguished Physician, Dana Farber Cancer Institute; Professor of Medicine, Harvard Medical School. Leader of DFCI/HCC Development Therapeutics; Member of NCI Investigational Drug Steering Committee; NCI Moonshot Immuno-oncology Translational Network
• Kwok-Kin Wong, M.D.: Chief of Hematology and Medical Oncology at The Perlmutter Cancer Center at NYU Langone Medical Center. Professor, Oncology, Dept. of Medicine; Director, Division of Hematology and Medical Oncology
• Joseph Paul Eder. M.D.: Professor of Medicine, Yale Cancer Center; Developmental Therapeutics - Phase 1 program
• Jonathan O. Rayner, Ph.D.: Associate Professor, Microbiology and Immunology; Director, Laboratory of Infectious Diseases at the University of South Alabama
• Paul Richardson, M.D.: Director of Clinical Research, Jerome Lipper Multiple Myeloma Center at Dana Farber; Professor of Medicine at Harvard Medical School
• Harpal Singh, Ph.D.: Professor of Biomedical Engineering, IIT-Delhi; Published 150+ publications and numerous patents in polymer chemistry
• Richard Stone, M.D.: Professor of Medicine at Harvard Medical School; Chief of Staff & Director of Translational Research in the Leukemia Division at the Dana-Farber Cancer Institute
• David Weaver, Ph.D.: CSO, FemtoDX; Former Head, Translational Medicine, Biomarkers, Verastem Inc.
• Surender Kharbanda, Ph.D.: Chief Founding Scientist, Hillstream; Head of Discovery, ILEX Oncology; CSO, Genus Oncology; 30+ years of drug discovery and development experience

HSB-888

• ASCO Abstract No. e15047 Co-loading of an anthracycline analogue Pirarubicin and Salinomycin in a 1:3 ratio into Quatramer biodegradable polymeric nanoparticles synergistically inhibit growth of triple-negative breast cancer. Summarizes non-clinical research in which HSB-1216 is being studied in combination with pirarubicin as dual drug-combination in a novel unique ratio in Quatramers for triple negative breast cancer (TNBC).
• HSB-888 has received Rare Pediatric Disease Designation (RPD) and Orphan Drug Designation for Osteosarcoma
• Loading of an anthracycline analogue Pirarubicin and Salinomycin in a 1:3 ratio into Quatramer biodegradable polymeric platform synergistically inhibits growth of TNBC (triple-negative breast cancer) cancer cells.

HSB-510

• Novel bi-functional mechanism of action targeting HDAC6 and PI3K-delta
• Third renewal in Cooperative Research and Development Agreement (CRADA) with the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH).
• Exploring use of Quatramer with HDAC6-PI3K-delta dual inhibitor in BCL-2 inhibitor resistant AML (acute myeloid leukemia), ALL (acute lymphoid leukemia) and MM (multiple myeloma)

TridentAI / Hillstream Ferroptomic Atlas / UMASS - CRISPR

• Collaboration with University of Massachusetts Chan Medical School to determine the chemogenetic interactions of HSB-1216, which utilizes the novel Quatramer technology, to further advance the Hillstream Ferroptomic Atlas for development of novel targets, gene regulatory networks and biomarkers.
• Using CRISPR mediated genome editing we plan to uncover novel targets and gene regulatory networks in ferroptosis / iron mediated cell death (IMCD) pathways

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

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 registration statement on Form S-1 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.com
www.hillstreambio.com

SOURCE: Hillstream BioPharma Inc.

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FAQ

What is Hillstream BioPharma's recent IPO amount and date?

Hillstream BioPharma successfully closed a $15 million IPO on January 14, 2022.

What is HSB-1216 and its significance?

HSB-1216 is a ferroptosis inducer targeting drug-resistant cancers, showing promising efficacy in clinical studies.

What designation did HSB-1216 receive from the FDA?

HSB-1216 received orphan drug designation from the FDA for the treatment of small cell lung cancer.

When does Hillstream plan to start clinical studies for HSB-1216?

Hillstream intends to launch clinical studies for HSB-1216 in 2022.

What platform does Hillstream use for its therapeutic candidates?

Hillstream uses the Quatramer tumor-targeting platform to enhance the delivery of its therapeutics.