Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company seeking to develop innovative medicines
in areas of significant unmet medical need in oncology and
infectious diseases with a current focus on breast cancer and
COVID-19, today issued the following letter from President and CEO
Dr. Steven C. Quay to Atossa stockholders:
To Our Valued Stockholders:
The last two years have changed the face of public health and
uncovered the urgency to develop products not only to prevent
widely spread infectious diseases, but to treat them with the same
level of focus and dedication applied to prevention. Despite the
launch of highly efficacious vaccines during 2021, the toll that
COVID-19 was taking on public health was not reduced. The rise of
the Omicron variant toward the end of the year, and emerging
long-term impact of long COVID, remain an important public health
priority, and one that Atossa is dedicated to addressing. A key
feature of the original SARS-CoV-2 virus, and that is retained in
both the Delta and Omicron variants, is the furin cleavage site
found on the Spike protein which facilitates viral infection. Our
COVID-19 programs under development are designed to interact with
this cleavage site so they are expected to be effective against
both current and future COVID-19 variants that continue to contain
a furin cleavage site.
In the meantime, we are also very excited about the ongoing
development of our breast health programs with our proprietary drug
Endoxifen, with one Phase 2 study underway and another expected to
commence in the next quarter. We raised over $110 million in
capital in 2021 and we are well positioned to execute on our
programs in 2022.
For all of our programs, our longer-term development strategy is
to complete clinical studies as rapidly as possible and then to
partner with leading research institutions or pharmaceutical
companies for later-stage development and commercialization. We are
also actively evaluating potential acquisition/in-licensing
opportunities of new programs to further drive stockholder
value.
We are pleased to report the following highlights of our recent
progress:
Endoxifen to Treat Breast Cancer in the Neoadjuvant
Setting (the Window Between Diagnosis and Surgery).
In 2021, we reported final results from our Endoxifen Phase 2
clinical study in Australia showing the primary endpoint was met, a
significant reduction in Ki-67, a common measure of breast cancer
tumor cell activity, which was reduced from an average of 25.6% at
screening to 6% on the day of surgery, a 65.1% reduction. All
adverse events were mild and considered related to the study drug,
and, based on these results, Endoxifen was considered safe and well
tolerated in this study.
In December 2021, we completed a pre-investigational new drug
(PIND) meeting with the FDA. The purpose of the meeting was to
obtain input from the FDA on pre-clinical, clinical, manufacturing
and regulatory matters in the U.S. for our proprietary Endoxifen to
treat breast cancer. Based on part on the feedback from the FDA, we
plan to open an IND for a multi-center Phase 2 study to further
advance our Endoxifen in the neoadjuvant setting. We plan to focus
our development on pre-menopausal women with estrogen receptor
positive (ER+), human epidermal growth factor receptor 2 negative
(HER2-) breast cancer for whom the current treatment options
typically include drugs that suppress ovarian function and
essentially force the patient into menopause.
During 2021 we continued to provide Endoxifen to a breast cancer
patient in an FDA-approved, expanded access (or “compassionate
use”) study. She has now received our oral Endoxifen for over three
years without recurrence of breast cancer or significant side
effects.
According to the American Cancer Society, 287,850 women are
expected to be diagnosed with breast cancer in the U.S. in 2022,
47,550 of which will be under the age of 50. Approximately 80% of
breast cancers are ER+.
Oral Endoxifen in Women with Mammographic Breast Density
(MBD).
In December 2021, we began to enroll participants in a Phase 2
clinical study of oral Endoxifen in women with increased
mammographic breast density (MBD). MBD is an emerging public health
issue affecting more than 10 million women in the United States and
many more worldwide. Studies conducted by others have shown that
increased MBD reduces the ability of mammograms to detect cancer
and increases the risk of developing breast cancer. Additional
studies show a correlation between MBD and the incidence of breast
cancer (the higher the MBD, the higher the incidence of breast
cancer) and that reducing MBD can lead to a reduction in the
incidence of breast cancer.
The study, known as the Karisma-Endoxifen study, is a Phase 2,
randomized, double-blind, placebo-controlled, dose-response study
of our proprietary Endoxifen in healthy pre-menopausal women with
increased breast density. The primary objective of the study is to
determine the dose-response relationship of daily oral Endoxifen on
MBD reduction, with secondary endpoints to assess safety and
tolerability, and an exploratory endpoint to assess durability of
the MBD changes after the study drug has been discontinued. It is
being conducted by South General Hospital in Stockholm and includes
approximately 240 participants who will receive daily doses of oral
Endoxifen or placebo for six months. The study is being led by
principal investigator Per Hall, M.D., Ph.D., Head of the
Department of Medical Epidemiology and Biostatistics at Karolinska
Institutet.
AT-301 Nasal Spray for the Treatment of
COVID-19.
AT-301 is a nasal spray we are developing for at-home treatment
of patients diagnosed with COVID-19 who do not require
hospitalization. During 2021, we completed our Phase 1 clinical
study demonstrating safety and tolerability in 32 study
participants. AT-301 was considered to be safe and well tolerated
in healthy male and female participants in this study at two
different dose levels over 14 days.
We received written feedback from the FDA and based in part on
that feedback we have been conducting additional pre-clinical
development before advancing to a Phase 2 study.
In addition to developing AT-301 nasal spray for COVID-19
patients recently diagnosed with the disease, we believe a
significant opportunity exists for the nasal spray to potentially
prevent COVID-19 in high-risk environments, such as people living
with an infected patient, people living and working in healthcare
facilities, emergency responders or teachers.
While the traditional vaccines have reduced the spread of
COVID-19 infections, it is also clear to us that therapies such as
AT-301 nasal spray will also play an important role, particularly
as the COVID-19 virus variants have necessitated booster vaccines
and potentially the development of vaccines that are
variant-specific. Deadlier and/or more transmissible variants of
COVID-19 continue to develop and reach the U.S. and in many other
countries and questions continue to remain regarding how effective
current and future vaccine’s may be against these and future
variants. Additionally, none of the currently available vaccines
are 100% effective, they may have side effects in selected
populations and effectiveness is expected to diminish over time.
For these reasons, we believe therapies like ours will provide
valuable protection even as vaccines continue to be developed and
deployed.
AT-H201 Inhalation Therapy for COVID-19.
AT-H201 is a proprietary combination of two drugs previously
approved by the FDA to treat other diseases. It is intended to
improve compromised lung function for moderate to severely ill,
hospitalized COVID-19 patients by inhalation. In May 2020, we
completed in vitro testing of AT-H201 that showed that the
components of AT-H201 inhibit SARS-CoV-2 infectivity of VERO cells,
which is a standard cell type being used to study infectivity of
the coronavirus. The AT-H201 components were found to be at least
four times more potent than remdesivir and at least 20 times more
potent than hydroxychloroquine.
In 2021 we initiated a Phase 1/2a placebo-controlled study in
Australia that will enroll a total of 60 healthy participants and
moderately-ill hospitalized COVID-19 patients. The study has 4
parts: a single ascending dose part which has now been completed, a
multiple ascending dose part, a combination part in healthy
individuals and a combination in COVID-19 infected patients. The
study is being conducted with Avance Clinical Pty Ltd., a leading
Australian clinical research organization.
Moving forward in 2022, we will continue to pursue our
mission with vigor and dedication and we have set the following
goals and milestones:
Endoxifen to Treat Breast Cancer in the Neoadjuvant
Setting. Our current plan is to continue developing our
proprietary Endoxifen for the treatment of pre-menopausal women
with ER+/HER2- breast cancer in the neoadjuvant setting. Atossa
plans to apply to the FDA for an IND to conduct a Phase 2 study in
the U.S. to compare Endoxifen to standard of care. Atossa also
plans to conduct a pharmacokinetic run-in study as a part of the
Phase 2 study to further define potential dose levels. We plan to
retain a leading U.S. research institution and CRO to work with us
on the study. We look forward to opening an IND in the second
quarter of 2022. We will then promptly commence a Phase 2 study in
this neoadjuvant setting.
Endoxifen for Women with Increased Mammographic Breast
Density. We will continue to enroll participants in our
Endoxifen Phase 2 clinical study in Stockholm.
COVID-19 Therapies. We plan to complete
enrollment in the second part of our ongoing AT-H201 Phase 1/2a
clinical study by the end of the second quarter 2022. In 2022, we
plan to continue the additional pre-clinical testing we are
conducting on our nasal spray AT-301 and then to further
characterize the API in AT-301 starting in the third quarter
2022.
On behalf of the board of directors, management and employees of
Atossa Therapeutics, we thank you for your investment and continued
support. The next period of Atossa’s history is just beginning and
I cannot wait to report Atossa’s successes as we move forward.
Sincerely,
Steven C. Quay, MD, Ph.D.President and Chief Executive
Officer
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical
company seeking to discover and develop innovative medicines in
areas of significant unmet medical need in oncology and infectious
diseases, with a current focus on breast cancer and COVID-19. For
more information, please visit www.atossatherapeutics.com.
Forward-Looking Statements Disclaimer
Statement
Forward-looking statements in this press release, which Atossa
undertakes no obligation to update, are subject to risks and
uncertainties that may cause actual results to differ materially
from the anticipated or estimated future results, including,
without limitation, statements regarding the satisfaction of
closing conditions relating to the offering and the anticipated use
of proceeds from the offering, the risks and uncertainties
associated with any variation between interim and final clinical
results, actions and inactions by the FDA, the outcome or timing of
regulatory approvals needed by Atossa including those needed to
commence studies of AT-H201, AT-301 and Endoxifen, lower than
anticipated rate of patient enrollment, estimated market size of
drugs under development, the safety and efficacy of Atossa’s
products, performance of clinical research organizations and
investigators, obstacles resulting from proprietary rights held by
others such as patent rights, whether reduction in Ki-67 or any
other result from a neoadjuvant study is an approvable endpoint for
oral Endoxifen, and other risks detailed from time to time in
Atossa’s filings with the Securities and Exchange Commission,
including without limitation its periodic reports on Form 10-K and
10-Q, each as amended and supplemented from time to time.
Company Contact:Atossa Therapeutics, Inc.Kyle
Guse, CFO and General CounselOffice: 866
893-4927kyle.guse@atossainc.com
Investor Relations
Contact:Core IROffice: 516
222-2560ir@atossainc.com
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