OS Therapies to Attend the 43rd Annual J.P. Morgan Healthcare Conference
03 1월 2025 - 1:16AM
Business Wire
- CEO Paul Romness available to meet with institutional
investors
OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage
biotechnology company advancing immunotherapies and targeted drug
conjugates for cancer treatment, today announced that its Chair
& CEO Paul Romness has accepted an invitation to attend the
43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA
taking place on January 13-16, 2025 in San Francisco, CA. This
premier conference is the largest and most informative health care
investment symposium in the industry which connects global industry
leaders, emerging fast-growth companies, innovative technology
creators and members of the investment community.
“After having successfully completed our IPO in 2024 and
finished the treatment phase of our potentially pivotal Phase 2b
clinical trial of lead therapeutic immunotherapy candidate OST-HER2
in the treatment of the rare pediatric disease recurrent, resected
metastatic Osteosarcoma, we are excited to begin to engage with the
institutional investor community and raise the profile of OS
Therapies in the capital markets,” said Paul Romness, MHP, Chair
and CEO of OS Therapies. “We intend to announce an update of the
data from this trial throughout the week of the conference and
expect that this will provide a good opportunity for the markets to
get a better understanding of our Company’s potential for an
approval in 2025 that would not only change the lives of families
afflicted by this devastating childhood cancer, but would also make
the Company eligible to be granted a Priority Review Voucher (PRV),
currently valued at approximately $150 million, that would further
capitalize the Company to allow it expand the clinical development
of OST-HER2 into other HER2 positive cancers such as Breast cancer
and/or Colorectal cancer.”
The US FDA granted OST-HER2 Rare Pediatric Disease Designation
for Osteosarcoma in 2021. The US FDA rare pediatric disease PRV
program aims to incentivize drug development for rare pediatric
diseases. Under this voucher program, a sponsor who receives an
approval for a drug or biological product for a rare pediatric
disease qualifies for a voucher that can be redeemed to receive
priority review for a different product. The sponsor may also
transfer or sell the voucher to another sponsor. OS Therapies
intends to sell the PRV it would earn upon receiving approval of
OST-HER2 for recurrent, resected metastatic Osteosarcoma. The most
recent publicly disclosed sale price of a PRV was on November 27,
2024 when PTC Therapeutics announced selling its PRV to Kebilidi
for $150M. With emerging scarcity in the PRV market, the Company
expects the value of PRVs to increase going forward. The maximum
sale price of a PRV was in 2015 when AbbVie bought a PRV from
United Therapeutics for $350 million.
The most recent continuing resolution (CR) negotiations in the
US House of Representatives failed to reauthorize the PRV program
for pediatric cancers such as Osteosarcoma. Despite this, as a
result of OS Therapies’ having been granted OST-HER2’s rare
pediatric disease designation prior to December 20, 2024 in
addition to the Company’s aim to receive an approval for OST-HER2
in the rare pediatric disease osteosarcoma in 2025, prior to the
September 30, 2026 deadline, OS Therapies remains eligible to
receive the PRV upon FDA approval of OST-HER2 in recurrent,
resected metastatic Osteosarcoma.
About OS Therapies
OS Therapies is a clinical stage oncology company focused on the
identification, development, and commercialization of treatments
for Osteosarcoma (OS) and other solid tumors. OST-HER2, the
Company's lead asset, is an immunotherapy leveraging the
immune-stimulatory effects of Listeria bacteria to initiate a
strong immune response targeting the HER2 protein. The Company has
completed enrollment for a 41-patient Phase 2b clinical trial of
OST-HER2 in resected, recurrent osteosarcoma, OST-HER2 has
completed a Phase 1 clinical study primarily in breast cancer
patients, in addition to showing preclinical efficacy data in
various models of breast cancer. OST-HER2 has been conditionally
approved by the U.S. Department of Agriculture for the treatment of
canines with osteosarcoma. In addition, OS Therapies is advancing
its next-generation Antibody Drug Conjugate (ADC) platform, known
as tunable ADC (tADC), which features tunable, tailored
antibody-linker-payload candidates. This platform leverages the
Company's proprietary silicone linker technology, enabling the
delivery of multiple payloads per linker. For more information,
please visit www.ostherapies.com.
Forward-Looking Statements
Statements in this press release about future expectations,
plans and prospects, as well as any other statements regarding
matters that are not historical facts, may constitute
forward-looking statements within the meaning of the federal
securities laws. These forward-looking statements and terms such as
"anticipate," "expect," "intend," "may," "will," "should" or other
comparable terms involve risks and uncertainties because they
relate to events and depend on circumstances that will occur in the
future. Those statements include statements regarding the intent,
belief or current expectations of OS Therapies and members of its
management, as well as the assumptions on which such statements are
based. OS Therapies cautions readers that forward-looking
statements are based on management’s expectations and assumptions
as of the date of this news release and are subject to certain
risks and uncertainties that could cause actual results to differ
materially, including, but not limited to the approval of OST-HER2
by the US FDA and grant of a priority review voucher and other
risks and uncertainties described in “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations” in the Company’s registration statement on
Form S-1 filed with the Securities and Exchange Commission (the
“SEC”) on November 12, 2024, as amended on November 27, 2024, and
other subsequent documents we file with the SEC, including but not
limited to our Quarterly Reports on Form 10-Q. Any forward-looking
statements contained in this press release speak only as of the
date hereof, and, except as required by the federal securities
laws, OS Therapies specifically disclaims any obligation to update
any forward-looking statement, whether as a result of new
information, future events or otherwise.
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OS Therapies Contact Information: Jack Doll 410-297-7793
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OS Therapies (AMEX:OSTX)
과거 데이터 주식 차트
부터 12월(12) 2024 으로 1월(1) 2025
OS Therapies (AMEX:OSTX)
과거 데이터 주식 차트
부터 1월(1) 2024 으로 1월(1) 2025