Atossa Therapeutics President and CEO Dr. Steven C. Quay Issues Annual Letter to Shareholders Highlighting Key Accomplishme...
January 22 2020 - 8:30AM
Atossa Therapeutics, Inc. (Nasdaq:ATOS) today issued the following
letter from Dr. Steven C. Quay, President and CEO, to Atossa
shareholders:
To Our Valued Shareholders:
I begin this letter with a sense of great pride about our
accomplishments at Atossa. During 2019, we focused on developing
our proprietary drug Endoxifen to reduce mammographic breast
density (MBD) and to treat breast cancer after a woman is diagnosed
but before her surgery. We advanced our goal of developing our
intraductal microcatheter technology to deliver drugs and
immunotherapies to treat breast cancer. Recent highlights in
advancing our goals include:
- Oral Endoxifen for MBD. Our lead program is to
develop our proprietary oral Endoxifen to reduce MBD. MBD is an
emerging public health issue affecting over 10 million women in the
United States. Studies conducted by others have shown that MBD
increases the risk of developing breast cancer and that reducing
MBD can reduce the incidence of breast cancer. In 2019, we
completed additional Phase 1 work with our oral Endoxifen, and, in
December 2019, we contracted with South General Hospital in
Stockholm, Sweden to conduct a Phase 2 study of our proprietary
oral Endoxifen to reduce MBD.
- Oral Endoxifen in the Window of Opportunity Between
Diagnosis and Surgery. In an FDA-approved, single patient,
expanded access (or “compassionate use”) study, a breast cancer
patient receiving our oral Endoxifen experienced a significant
reduction in cancer cell biological activity - the Ki-67 activity
decreased by 50 percent, and the estrogen receptor content
decreased by over 20 percent. The patient has continued to take
oral Endoxifen in the adjuvant setting following her surgery. We
also have an ongoing Phase 2 study underway in Australia
administering our oral Endoxifen to women in the window of
opportunity.
- Topical Endoxifen for MBD. We have also been
developing a topical form of Endoxifen which is applied to the skin
like a lotion. In June 2019, we announced the results from our
Phase 2 study using this topical formulation to reduce MBD, which
indicated that our proprietary 20mg daily topical Endoxifen showed
significant and rapid reduction in MBD. Because study participants
experienced skin rashes and local irritation we will reevaluate the
topical form once we complete the Phase 2 study of oral
Endoxifen.
- Intraductal Microcatheter Technology. We
recently advanced our intraductal microcatheter technology program
with the IRB approval of a Phase 2 clinical study using our
intraductal microcatheter technology to administer fulvestrant in
patients with early-stage breast cancer or ductal carcinoma in
situ (DCIS). The study is being conducted at a world-class
teaching, research and healthcare organization based in the United
States. We also advanced our intraductal R&D program by
developing a model in mice using our intraductal microcatheter
technology. This is an important accomplishment, as this model
will enable us to identify potential immunotherapy candidates to
move forward into clinical trials.
Finally, we are particularly pleased to have announced that we
have changed the name of the company from Atossa Genetics to Atossa
Therapeutics, which we believe more clearly reflects our focus on
developing therapies and continues to honor Princess Atossa, the
great queen of the Achaemenid Empire, who reigned in the fifth
century BCE and who is the earliest recorded woman with breast
cancer.
Moving forward in 2020, we will continue to pursue our mission
with vigor and dedication:
- Oral Endoxifen to Reduce MBD. Our primary goal
in 2020 is advancing oral Endoxifen through a Phase 2 study to
reduce MBD. The primary objective of this randomized,
double-blinded, placebo-controlled study is to determine if there
was a change in breast density compared to placebo and among
different doses, with secondary endpoints to assess and
characterize safety and tolerability. South General Hospital in
Stockholm will be conducting this study at multiple sites, after
having recently completed our Phase 2 study of our topical form of
Endoxifen. The study is being led by principal investigator Dr. Per
Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology
and Biostatistics at Karolinska Institutet. We expected to enroll
approximately 1,000 pre-menopausal participants in four groups who
will be dosed for six months.
In
2019, we completed additional Phase 1 work using our capsule
Endoxifen and a new modified-release form of our oral Endoxifen.
Study results showed that the capsule and tablet were safe and
well-tolerated. Because the pharmacokinetics of the tablet did not
appear to be significantly improved over our capsule and because
the capsule is more cost-effective to manufacture, we plan to use
our capsule formulation of Endoxifen in our upcoming Phase 2 study
to reduce
MBD. Upcoming
2020 milestones with this program include receiving approval to
open the study from the Institutional Review Board and Medical
Products Authority in the first quarter 2020. We will then begin
enrolling participants in the first or second quarter of 2020 and
we expect to report periodically the progress with
enrollment.
- Oral Endoxifen in the “Window of Opportunity” Between
Diagnosis of Breast Cancer and Surgery. We plan to
continue enrolling participants in this Phase 2 study being
conducted in Australia.
- Intraductal Technology. We plan to continue
our Phase 2 study using our intraductal technology to administer
Fulvestrant and we will be conducting additional pre-clinical work
to identify potential immunotherapy candidates.
- Gynecomastia. Completing our Phase 2 study of
MBD will help inform next steps with our program to treat and/or
prevent gynecomastia with our proprietary Endoxifen. Accordingly,
we don’t anticipate advancing our gynecomastia program in
2020.
Atossa is an exceptional company focused on novel therapeutics
and delivery methods for MBD and breast cancer. We look forward to
reporting our progress on our priorities throughout the year and we
thank you for your continued support of Atossa.
Sincerely,
Dr. Steven C. Quay, MD, Ph.D.President and Chief Executive
Officer
About Atossa Therapeutics
Atossa Therapeutics, Inc. (Nasdaq:ATOS) is a clinical-stage
pharmaceutical company developing novel therapeutics and delivery
methods to treat breast cancer and other breast conditions. For
more information, please visit www.atossatherapeutics.com.
Forward-Looking Statements
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 the
risks and uncertainties associated with actions and inactions by
the FDA, the outcome or timing of regulatory approvals needed by
Atossa, lower than anticipated rate of patient enrollment, results
of clinical studies, the safety and efficacy of Atossa’s products
and services, performance of clinical research organizations and
investigators, obstacles resulting from proprietary rights held by
others, such as patent rights, 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.
Atossa Genetics Company Contact:
Kyle Guse CFO and General Counsel (206) 556-3238
kyle.guse@atossainc.com
Investor Relations Contact:
Scott Gordon CorProminence LLC 377 Oak Street Concourse 2 Garden
City, NY 11530 Office: (516) 222-2560 scottg@coreir.com
Source: Atossa Therapeutics, Inc.
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