- Recent milestones include FDA Orphan Drug Designations for HSB-1216 and HSB-888
- World-class scientific advisory team and growing and distinguished patent portfolio remain key competitive advantages
- Company ended Q1 2022 with $11 million in cash
- Provides roadmap of clinical plans through 2023
BRIDGEWATER, N.J., June 02, 2022 (GLOBE NEWSWIRE) -- 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, today provided a corporate update for its investors and a roadmap of clinical studies through 2023.
“We have demonstrated strong execution and as a result have seen significant advancement of our pipeline,” said Randy Milby, Hillstream’s Chief Executive Officer. “We received FDA Orphan Drug Designation for our lead drug candidate, HSB-1216, for the treatment of Uveal Melanoma, in addition to the Orphan Drug Designation for small-cell lung cancer. Our second drug candidate, HSB-888, also has the Orphan Drug Designation and a Rare Pediatric Disease Designation (RPD) for pediatric osteosarcoma. We remain committed and laser-focused on our mission to improve the lives of patients suffering from rare, drug-resistant cancers. Looking forward, we have several important clinical milestones that we expect to achieve over the next 12 to 18 months. We are confident that our current financial capitalization levels will allow us to meet and exceed our expectations.”
Recent Milestone Announcements
The Company’s lead drug candidate, HSB-1216, was granted Orphan Drug Designation to treat Uveal Melanoma (UM) by the FDA. The Orphan Drug Designation program provides orphan status to drugs and biologics, 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 U.S.
UM is the most common primary intraocular tumor that originates from melanocytes of the eye uveal tract, accounting 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 the removal of primary tumors. This designation significantly expands Hillstream’s oncology efforts and diversifies its lead program.
For HSB-888, Hillstream’s second product candidate is a Quatramer dual-loaded with an IMCD inducer coupled with our ultra-low-dose, next-generation anthracycline analog for solid tumors. HSB-888 has demonstrated highly synergistic tumor-killing capacity in a TNBC cell line. HSB-888’s active moiety has also received FDA’s Rare Pediatric Disease Designation and Orphan Drug Designation for pediatric osteosarcoma.
World-Class Scientific Advisory Board and Distinguished Patent Portfolio
Hillstream’s dedicated world-class scientific advisory board and distinguished and growing patent portfolio remain key competitive advantages as the Company navigates through the clinical and commercialization stages of development.
The variety of experiences in cancer research and knowledge of drug-resistant cancers that are represented on the Board are critical human capital components that will drive the success of the business strategy. Hillstream has collaborations with the National Center for Advancing Translational Sciences, Dana-Farber Cancer Institute, Minotaur Therapeutics, the University of Massachusetts Chan Medical School, the Indian Institute of Technology Delhi, and several other prestigious universities in the U.S. and worldwide.
The Company’s growing and distinguished patent portfolio consists of 21 patents allowed and granted for polymeric nanoparticles with different active drugs, polymeric nanoparticles containing the active drug in HSB-1216, and the manufacturing process for polymeric nanoparticles. The current patent portfolio for those patents granted expires at the end of 2036. Additionally, there are approximately 25 patents that are still in pending status.
Recent Communications with Industry Experts and the Investment Community
In the past few months, management participated in various industry events and investor conferences to communicate its proprietary technology, the Quatramer, its tumor-targeting platform and mechanisms for the treatment of drug-resistant cancers and rare, devastating cancers. These events included an R&D day and BioNJ’s 12th Annual BioPartnering Conference. Upcoming events include attending World Orphan Drug Congress USA July 11-13, 2022, and investor presentations.
Most notably, the Company recently received sell-side coverage by ThinkEquity analyst Ashok Kumar, Ph.D., CFA., who cited a positive recommendation for Hillstream.
Solid Financial Condition
As of the quarter ended March 31, 2022, Hillstream had $11.1 million in cash. The Company received total proceeds of $15 million through the issuance of common stock during its January 2022 initial public offering on the NASDAQ Exchange. The Company has sufficient capital to manage the business for the next 12 months.
Notable Milestones Through 2023
- For HSB-1216:
- Q4 2022: Initiation of GMP manufacture and Phase 0 study in Australia.
- 1H 2023: Completion of IND studies
- 2H 2023: Initiate Phase 1 clinical trial
- Moving forward, Hillstream expects to advance pre-clinical studies for other products, including HSB-888 and HSB-510.
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
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4b8694d4-9bcc-437c-990c-4a266b8edc9f
