Hillstream BioPharma (HILS) Provides Corporate Update

Hillstream BioPharma, Inc. (Nasdaq: HILS) 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 ConditionAs 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.

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