Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company seeking to discover and develop
innovative medicines in areas of significant unmet medical needs 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:
With the onset of COVID-19, the year 2020 will be
remembered as one that changed the entire paradigm of business, the
way we lead our daily lives and the world. I am deeply saddened by
the devastating loss of life and the countless challenges the
pandemic has created worldwide. With the ease of transmission, new
variants emerging and the current limits of vaccines, we believe
COVID-19 will be with us for the foreseeable future and we aim to
be a part of the solution.
During the past twelve months, despite the pandemic
and the associated global disruptions, we continued to deliver on
our corporate and clinical milestones, expanded our pipeline, and
significantly strengthened our balance sheet by adding
approximately $81 million in net proceeds. We are in a strong
position to continue the development of our programs and
opportunistically add accretive programs as we move forward.
While much work still lies ahead, we are pleased to
report the following highlights of our progress:
AT-301 Nasal Spray for the Treatment of
COVID-19. AT-301 is a nasal spray being developed for
at-home treatment of patients diagnosed with COVID-19 who do not
require hospitalization. During 2020, we completed successful
in-vitro testing followed by a Phase 1 clinical study with
preliminary data demonstrating safety and tolerability. We recently
received written feedback from the FDA from a pre-IND meeting that
is informing our clinical and regulatory strategy. We expect to
release final data from this study in the first quarter of 2021 and
then quickly start additional pre-clinical and clinical studies to
support an investigational new drug application (IND) with the FDA.
We are in the process of identifying potential partners for this
program. For example, an ideal partner may be selling diagnostic
tests for COVID-19 so that our nasal spray could be co-promoted
with the diagnostic test once all regulatory approvals are
obtained.
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 we hope that traditional vaccines will be
effective in reducing 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 it becomes clear that it will take
months or years for vaccines to be administered around the world.
New deadlier and/or more infective variants of COVID-19 are being
reported in the U.S. and in many other countries and it is not
clear that current vaccines will be completely effective against
these and future variants. Additionally, none of the currently
available vaccines are 100% effective, they may have more
significant side effects in older people 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. Based in part on our success with
other clinical studies in Australia, we have applied to the
regulatory authorities to conduct the initial clinical study of
AT-H201 in Australia, which we anticipate receiving in first
quarter 2021.
Oral Endoxifen in the Window of Opportunity
Between Diagnosis and Surgery. In 2020, we made tremendous
progress developing oral Endoxifen in the window of opportunity
between diagnosis of breast cancer and surgical treatment. In
May 2020, we reported interim results from our Phase 2 study in
Australia showing a statistically significant (p=0.031) reduction
of about 74% in tumor cell proliferation was achieved in the
initial patients, as measured by Ki-67, over an average 22 days of
dosing. Ki-67 is a recognized standard measurement of breast cancer
cell proliferation. Six out of the initial six (100%) patients
experienced a significant reduction in Ki-67 and each had a Ki-67
below 25% after treatment, which is the threshold identified in
research by others for predicting overall survival. Results to date
from this open-label study are sufficiently compelling that we have
halted the study, shortening our development time-line by
approximately one year. In the second quarter 2021, we plan to
report final data from the study and obtain input from the FDA to
inform our pathway for further development in the U.S.
A breast cancer patient in an FDA-approved,
expanded access (or “compassionate use”) study has now received our
oral Endoxifen for over two years without recurrence of breast
cancer or significant side effects.
Oral Endoxifen to Reduce Mammographic
Breast Density (MBD). We have contracted with South
General Hospital in Stockholm to conduct a randomized,
double-blinded, placebo-controlled Phase 2 study to reduce MBD in
pre-menopausal women dosed over six months. This study will be led
by principal investigator Dr. Per Hall, M.D., Ph.D., Head of the
Department of Medical Epidemiology and Biostatistics at Karolinska
Institutet. This study will evaluate safety, tolerability and
efficacy of our oral Endoxifen. The study is subject to approval by
the European Medical Product Authority and ethics board. We expect
to open this study in Stockholm soon after receiving all
necessary regulatory approvals, provided COVID-19 restrictions are
lifted to permit patient recruitment.
Fundraising Activities. At the end
of this year and moving into the beginning of 2021, Atossa raised
in excess of $81 million, which comfortably positions the Company
to conduct its current programs through 2021 and beyond.
Moving forward in 2021, we will continue to
pursue our mission with vigor and dedication and we have set the
following goals and milestones:
COVID-19 Therapies. We expect to
release final data from our Phase 1 study of AT-301 in the first
quarter of 2021 and then quickly start additional pre-clinical and
clinical studies to support an IND with the FDA. We are in the
process of identifying potential partners for this program. We
expect to receive regulatory approval in the first quarter 2021 to
commence additional pre-clinical and clinical studies of AT-H201 in
Australia.
Oral Endoxifen. In the second
quarter 2021, we plan to report final data from our Australian
window of opportunity Phase 2 study and obtain input from the FDA
for further development in the U.S. Subject to receiving all
regulatory clearances, we plan to commence a Phase 2 study of oral
Endoxifen to reduce MBD in Stockholm as soon as COVID-19
restrictions allow.
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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