- Strong cash position relative to monthly burn and cash needs
into mid-2026
- Significant regulatory milestones upcoming in OST-HER2
osteosarcoma program
- Pending acquisition paves the way for commercialization and
partnerships
- Evaluating strategic options for tunable Antibody Drug
Conjugate platform
OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage
biotechnology company advancing immunotherapies and targeted drug
conjugates for cancer treatment, today provided a corporate update
to the marketplace to contextualize recent positive clinical data,
corporate and financial developments.
“January 2025 was the most significant month in the Company’s
history,” said Paul Romness, MHP, Chairman & CEO of OS
Therapies. “We started OS Therapies because someone very close to
my family developed osteosarcoma and we realized that if first line
therapy failed, the metastasis that could follow had very poor
long-term prognosis. The data we generated in our Phase 2b trial
with OST-HER2 provides the first glimmer of hope in over 40 years
that a paradigm shift could radically change the course of this
deadly disease. We intend to stay laser focused on our mission of
bringing this therapy to market so that when the next family that
gets the devastating news of an osteosarcoma diagnosis, they’ll
know that treatment options might exist in the event that
chemotherapy and resection/amputation fail to prevent metastasis,
which is the case in approximately 50% of patients.”
Cash position and burn
rate
On January 14, 2025, the Company disclosed that it completed a
$7.1 million financing round (the “Preferred Round”) designed to
fund the Company through a Biologics Licensing Authorization (BLA)
decision from the US Food & Drug Administration (“FDA”)
regarding the OST-HER2 program in the prevention of metastases in
osteosarcoma. This was in addition to the $6 million initial public
offering the Company completed in August 2024. Taken together, this
$13.1 million that the Company raised over the last 6 months
provides sufficient capital to fund:
- Final payments for the OST-HER2 osteosarcoma trial (inclusive
of any expected non-clinical work required by FDA).
- Commercial manufacturing required for FDA approval and product
launch.
- Strategic & operational costs related to FDA & EMEA
correspondence, meetings, and regulatory submissions.
- Commercial launch preparations.
- Acquisition of the Listeria monocytogenes (“Listeria”) platform
from Ayala.
- Corporate overhead.
Under the terms of the Preferred Round, the Company is precluded
from raising additional capital for 6 months, in addition to being
precluded from selling shares under its Equity Line of Credit
(“ELOC”) so long as the price of the common stock is below $12.00.
Additionally, the warrants issued in connection with the Preferred
Round have certain forced exercise provisions when the common stock
trades above $12.00.
An additional condition of the Preferred Round was the
appointment of Mr. Karim Galzahr as a new member of the Company’s
Board of Directors to help the Company navigate towards value
creation for shareholders. The Preferred Round was funded over 90%
by pre-IPO and IPO investors of the Company, including leading
funders from the osteosarcoma community. As a result of the
significant investment made to help advance OS Therapies’ mission,
certain investors are now considered affiliates of the Company by
virtue of owning at least 10% of the common shares. It is important
to note that while this significant ownership entitles the
investors to representation, it also binds them to certain SEC
requirements as it relates to liquidity, thus providing a layer of
protection for all shareholders. To read more about affiliate
Trading Volume Formula please visit:
https://www.sec.gov/about/reports-publications/investorpubsrule144.
We also acknowledge the Company’s shares have experienced
significant volatility in recent months. We believe this in large
part due to the expiration of the lockup of pre-IPO shares that
occurred on the week of January 27, 2025. The vast majority of our
pre-IPO shareholders invested in the Company to succeed in its
mission of delivering a new treatment option for osteosarcoma
patients.
The Company expects to complete a number of key milestones
towards FDA approval. We are engaging with new institutional and
retail investors to expand our shareholder base. Approval of
OST-HER2 for osteosarcoma on or before September 30, 2026 (the
Company is targeting a late 2025 approval) would grandfather into
the FDA’s sunsetting Priority Review Voucher (“PRV”) program by
virtue of the Rare Pediatric Disease Designation (“RPDD”) the FDA
granted to the Company in 2021. This would result in non-dilutive
capital, expected in the $150 million range.
Regulatory Path to Approval for
OST-HER2 in Osteosarcoma
On January 15, 2025, the Company announced that it achieved the
primary endpoint with statistical significance in its Phase 2b
clinical trial of OST-HER2 in the prevention of recurrent, fully
resected, lung metastatic osteosarcoma. In discussions prior to the
initiation of the Phase 2b study, FDA recommended 12-month Event
Free Survival as the primary endpoint for a successful objective
treatment response (“Responders”). The data showed that in
comparison with the best available historical control group from
United States published literature (the “Published Control”):
- 33% of OST-HER2 patients were Responders vs. 20% in the
Published Control.
- A greater proportion of OST-HER2 treated patients vs. the
Published Control were alive at the post-Resection interim 12-month
timepoint (91% vs. 80%) and 24-month timepoints (61% vs. 40%) than
the Published Control, in the 3-year overall survival secondary
endpoint.
- 100% of patients on OST-HER2 who were disease free at 12 months
were alive at the 12-month, 18-month, 24-month and 30-month
timepoints, as of each of their last dates of contact.
- OST-HER2 was well tolerated, with a strong safety profile that
is sufficient to support regulatory approval.
Additionally, in preparation for further regulatory discussions
with FDA regarding submission of OST-HER2 for accelerated or full
approval, the Company sourced the only available database of
osteosarcoma patients treated with the standard of care in the US
to establish a matched historical external control arm (the
“Matched Control”). We did this after receiving feedback from FDA
regarding a Breakthrough Therapy Designation (“BTD”) request that
noted the clinical subpopulation we studied in the Phase 2b trial
met the BTD criteria and that a matched historical external control
would be required to determination clinical efficacy. The Matched
Control will provide the clinical comparator required by FDA to
support approval, based on advice from senior regulatory advisors
with experience in getting pediatric orphan therapies approved.
While there were insufficient numbers of data points available to
finalize the submission package for FDA as of January 2025, the
interim data collected on the Primary Endpoint showed:
- 33% of OST-HER2 treated patients were Responders vs. 11% in
Matched Control
- In Non-Responders, the average time to recurrence was 5.9
months in OST-HER2 treated patients vs. 4.7 months in Matched
Control.
In further discussions with key members of our Regulatory and
Scientific Advisory Board, subgroup analyses that focused on the
response to therapy among patients at different stages of disease
offered important insight into the potential importance of OST-HER2
for patients and clinicians in osteosarcoma. In the OST-HER2
treated group:
- Patients who had multiple Resections (2+) showed greater
propensity (55%) for achieving 12-month EFS than patients who had
previously had only one Resection (25%);
- Patients who previously had only one Resection (25%) still
performed better than patients from the Published Control (20%) and
the Matched Control (11%).
The likelihood that patients who have had multiple lung
metastasis resections were Responders at a 55% rate was important
to clinicians because patients with 1 prior Resection will likely
progress to having multiple resections, with near 100% certainty.
This makes OST-HER2 a therapy likely appropriate for a large
proportion of patients.
Taken together, the Company believes the efficacy data Matched
Control will ultimately support regulatory approval in the
prevention of metastases in osteosarcoma, considering the lack of
options available in the market, the poor survival outcomes for
patients and the strong safety profile of OST-HER2. The Company is
working with both domestic and European osteosarcoma research
groups to gather additional non-concurrent control arm data for FDA
review.
The Company intends to request a meeting (either Type B or Type
C) with FDA to review the data and discuss the path towards BLA
once the additional Matched Control data is ready for submission,
expected in the first quarter of 2025. The Company expects meeting
with FDA early in the second quarter of 2025. Later in the second
quarter we plan to file the BLA, provided positive feedback from
FDA. Upon filing the BLA, the Company expects approval within 6
months.
Additionally, the Company owns the rights to OST-HER2 in
canines, with strong efficacy data previously published. While the
Company has prioritized development of OST-HER2 for humans with
osteosarcoma, it does intend to make progress in making the
conditionally-approved treatment available where possible while it
works to secure full regulatory approval so that it can be made
broadly accessible. Additional information will be forthcoming on
this effort in the months ahead.
Acquisition of Clinical Assets and IP
from Ayala
On January 29, 2025, the Company announced that it entered into
an agreement to acquire certain clinical and intellectual property
assets from Ayala (the “Acquisition”). As a result of the
Acquisition, the Company gained rights to two new Listeria-based
clinical-stage immunotherapy candidates: ADXS-503 for lung cancer
and ADXS-504 for prostate cancer. While the clinical data for these
candidates is encouraging, the primary reason the Company moved
forward with the Acquisition was to eliminate an expected near-term
cash milestone of $3.5 million due upon the earlier of receiving
FDA approval of OST-HER2 or initiating a pivotal trial for OST-HER2
in a clinical indication. Given the likelihood that the recently
completed Phase 2b clinical trial of OST-HER2 would be considered
pivotal by virtue of the expectation that FDA will allow the data
gathered to become the primary efficacy data utilized for BLA
submission, this agreement reduces our expected cash needs for
2025. Additionally, the Acquisition reduces the Company’s royalty
rate from 10% to 1.5% of net sales and eliminates $16.5 million in
milestones on the first $100 million in sales, dramatically
improving the potential margin gained by the Company in the early
years for OST-HER2 in osteosarcoma.
The Company is now positioned as the clear market leader in
Listeria-based immunotherapy, a long-promising class of cancer
immunotherapy. We expect it to become an important treatment option
in situations where no treatments exist, such as recurrent,
metastatic osteosarcoma, as well as an adjunct to the standard of
care where treatment fails or is insufficient. There was previously
considerable enthusiasm around the use of Listeria as an
immunotherapy platform in cancer, and we believed this enthusiasm
will renew as OST-HER2 makes its way through the FDA approval
process.
Strategic options for our tunable
Antibody & other Drug Conjugate platform
With the solidification of OS Therapies as the market leader in
Listeria-based immunotherapy, we expect that the development
funding priorities post-approval of OST-HER2 in osteosarcoma will
be to evaluate OST-HER2 in other HER2-related oncology areas, as
well as identify paths forward for ADXS-503 (to be renamed OST-503)
in lung cancer and ADXS-504 (to be renamed OST-504) in prostate
cancer - two large therapeutic areas with significant unmet medical
need.
The Company will accelerate the development of our
groundbreaking tunable drug conjugate platform based on
pH-sensitive tunable linker technology, capable of linking multiple
different therapeutic payload combinations with multiple different
targeting antibodies - without using our existing cash resources
for development. Given the continued market interest in combining
therapeutic interventions, such as antibody and vascular targeted
drugs to target specific cancer cells, we believe our tunable drug
conjugate platform could play an outsized role in creating
combination therapies that will improve outcomes while reducing
side effects.
We will announce strategic options in the near future.
Conclusion
Our journey as a newly public company resulted in significant
clinical and business accomplishments, alongside known challenges
for biotechnology companies with relatively small capitalizations.
OS Therapies is different from others because the Company has
completed its capital-intensive clinical development phase. We are
fully funded through a potential PRV sale - a significant revenue
generating milestone. These distinctions could separate OS
Therapies from others in this challenging biotech funding
environment as the market becomes aware of our positioning.
We thank the patients, families, clinicians and investors who
believe in the mission of the Company to improve outcomes for
osteosarcoma, and other solid tumors.
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. OST-HER2 has
received rare pediatric disease, fast-track and orphan drug
designations from the US FDA. The Company has completed enrollment
for a 41-patient Phase 2b clinical trial of OST-HER2 in recurrent,
fully resected, lung metastatic osteosarcoma, with positive results
released in the first quarter of 2025. The Company anticipates
submitting a Biologics Licensing Application (BLA) to the US FDA
for OST-HER2 in osteosarcoma in 2025 and, if approved, would become
eligible to receive a Priority Review Voucher that it could then
sell. 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
silicon linker technology, enabling the delivery of multiple
payloads per molecule. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250204605699/en/
OS Therapies Contact Information:
Jack Doll 571.243.9455 Irpr@ostherapies.com
https://x.com/OSTherapies https://www.instagram.com/ostherapies/
https://www.facebook.com/OSTherapies/
https://www.linkedin.com/company/os-therapies/
Grafico Azioni OS Therapies (AMEX:OSTX)
Storico
Da Gen 2025 a Feb 2025
Grafico Azioni OS Therapies (AMEX:OSTX)
Storico
Da Feb 2024 a Feb 2025
