OS Therapies Incorporated (“OS Therapies” or the
“Company”) (NYSE-A: OSTX), an Antibody Drug Conjugate (ADC) and
Immunotherapy research and clinical stage biopharmaceutical
company, today announced the pricing of its initial public offering
of 1,600,000 shares of common stock at a public offering price of
$4.00 per share, raising gross proceeds of $6.4 million.
Additionally, the Company has granted the underwriters a 45-day
option to purchase up to an additional 240,000 shares of common
stock at the public offering price, less underwriting discounts and
commissions, to cover over-allotments, if any.
The net proceeds, after deducting underwriting discounts and
commissions, but before estimated expenses of the offering payable
by the Company, are expected to be approximately $6.0 million. The
Company intends to use the net proceeds from the offering to
advance the clinical development of its product candidates –
OST-HER2 and OST-tADC – and discover and develop new product
candidates, as well as for working capital and other general
corporate purposes.
OS Therapies’ lead product candidate, OST-HER2, is an innovative
immunotherapy using a HER2 bioengineered form of the bacteria
Listeria monocytogenes (Lm) to trigger a strong immune response
against cancer cells expressing HER2. This off-the-shelf treatment
is designed to prevent metastasis, delay recurrence, kill primary
tumors expressing HER2 and increase overall survival. Currently,
the Company has fully enrolled a potentially pivotal Phase IIb
clinical trial in recurred, resected osteosarcoma, dosing 41
patients with OST-HER2 at 21 clinical trial sites across the United
States, with topline data expected in the fourth quarter of 2024
following the release of interim data in June 2024. OST-HER2 has
received Rare Pediatric Disease Designation (RPDD) from the Food
and Drug Administration (FDA), and Fast Track and Orphan Drug
Designations by the FDA and European Medicines Agency (EMA). OS
Therapies is seeking Breakthrough Therapy Designation for OST-HER2
for osteosarcoma from the FDA based on data from its Phase IIb
clinical trial. Upon any Biologics Licensing Authorization (BLA)
from the FDA for OST-HER2 in osteosarcoma, the Company will be
granted a Priority Review Voucher based upon the RPDD. OST HER2 has
also completed a Phase 1 clinical trial primarily in breast cancer
patients, in addition to strong preclinical data demonstrating
efficacy on a standalone basis and in combination with
HER2-targeting therapeutic antibodies such as Herceptin®.
OS Therapies is also developing OST-tADC, a proprietary
next-generation Antibody Drug Conjugate (ADC) platform. This
advanced technology incorporates pH-sensitive silicon-based linkers
and coating, trademarked as SiLinkers™, which can release multiple
therapeutic agents selectively within the tumor microenvironment,
which experiences lower pH levels than the rest of the body. This
approach aims to maximize the therapeutic effects while minimizing
damage to healthy cells. OS Therapies has completed initial safety
and efficacy proof of concept in various murine models of
cancer.
The total addressable market for human osteosarcoma is estimated
at $1.72 billion. The global market for ADCs is anticipated to
reach $19.8 billion by 2028, according to data from
MarketsandMarkets.
OS Therapies’ common stock is expected to begin trading on the
NYSE American stock exchange tomorrow, Thursday, August 1, 2024,
under the symbol “OSTX.” The public offering is expected to close
on Friday, August 2, 2024, subject to customary closing
conditions.
Brookline Capital Markets, a division of Arcadia Securities, LLC
is acting as sole book-running manager for the offering. Olshan
Frome Wolosky LLP is serving as counsel to the Company and
Sichenzia Ross Ference Carmel LLP is serving as counsel to the
underwriters in the offering.
A registration statement on Form S-1 (File No. 333-279839)
relating to this offering was filed with the Securities and
Exchange Commission (the “SEC”) and was declared effective on July
31, 2024. This offering is being made only by means of a
prospectus. A copy of the final prospectus related to this offering
may be obtained, when available, from Brookline Capital Markets,
via email to michael.fontaine@brooklinecapmkts.com or by calling
(646) 256-5258. In addition, a copy of the final prospectus
relating to this offering may be obtained, when available, from the
SEC’s website at www.sec.gov.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy any securities in the offering, nor
shall there be any sale of these securities in any state or
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction.
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, with results expected in the fourth quarter
of 2024. OST-HER2 has completed a Phase 1 clinical study primarily
in breast cancer patients, in addition to showing strong
preclinical efficacy data in various models of breast cancer. 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.
About Osteosarcoma
Osteosarcoma is a solid tumor of the bone that predominantly
occurs in children and young adults. It is an extremely challenging
and often aggressive cancer that has particular treatment
challenges due to its location, changing genotypes and high
recurrence rates. Standard treatment includes surgery and
chemotherapy. For patients with metastatic or recurrence after
chemotherapy, there is a significantly poorer prognosis.
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 offer and
sale of shares, the timing of the listing of OS Therapies’ common
stock on the NYSE American, the timing of the closing of the
offering, the use of the proceeds from the sale of shares of common
stock in the offering, and 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. Prospective
investors are cautioned that any such forward-looking statements
are not guarantees of future performance and involve risks and
uncertainties, including those described under the caption “Risk
Factors” and elsewhere in the prospectus filed with the SEC
relating to the offering and that actual results may differ
materially from those indicated by such forward-looking statements.
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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version on businesswire.com: https://www.businesswire.com/news/home/20240731616879/en/
Corporate & Media Contact: Jack Doll 410-297-7793
irpr@ostherapies.com
For Underwriter Inquiries: Brookline Capital Markets, a
division of Arcadia Securities, LLC Michael Fontaine, Managing
Partner (646) 256-5258 michael.fontaine@brooklinecapmkts.com
Investor Relations: Dave Gentry RedChip Companies, Inc.
1-407-644-4256 OSTX@redchip.com
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