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 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.
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 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
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.comwww.hillstreambio.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/4b8694d4-9bcc-437c-990c-4a266b8edc9f
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