Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage
biopharmaceutical company developing innovative medicines in areas
of significant unmet medical need in oncology with a focus on
breast cancer, today announces the issuance of the following Letter
to Shareholders from Steven Quay, M.D., Ph.D., the Company’s
President and Chief Executive Officer:
To our valued shareholders:
2023 marked another year of significant progress for Atossa.
There are now four Phase 2 trials underway investigating our
proprietary (Z)-endoxifen, with primary data expected from two of
these trials in the second half of this year. We also initiated
important research with Weill Cornell Medicine that could
fundamentally transform treatment options for patients diagnosed
with one of the most aggressive and deadly forms of breast
cancer.
Our study that is furthest along is the Phase 2
Karisma-Endoxifen trial, which reached full enrollment in November
2023. In this study, we are looking at the effect (Z)-endoxifen has
in premenopausal women with measurable breast density. Participants
in the study are randomized into one of three cohorts to receive
placebo, 1mg or 2mg of (Z)-endoxifen daily for six months.
Mammograms are conducted to measure reduction in breast density
over the treatment period and a final mammogram will be conducted
at 24 months to assess the durability of density changes. If you
would like to learn more about the study, please visit
www.atossatherapeutics.com to view a short video interview I
conducted with Dr. Per Hall, the Karsima-Endoxifen study primary
investigator.
Simply put, breast density is a health crisis. Almost half of
the women in the world over the age of 40 have dense breasts and
this condition not only makes mammograms far less effective, but it
also significantly increases the likelihood that a woman will
develop breast cancer in their lifetime. Adding to the issue is the
fact that there are currently no approved treatments to reduce
breast density.
Breast density and the associated risk factors are not well
understood by most women, although that will begin to change in the
United States on September 10 of this year when a federal law
requiring mammography facilities to notify patients about the
density of their breasts goes into effect. The notification for
patients with dense breasts will include a warning that dense
tissue makes it harder to find breast cancer on a mammogram and
raises their risk of developing breast cancer.
The notification will also encourage women with dense breast
tissue to discuss the findings with their healthcare provider,
which means the number of conversations medical professionals will
be having with patients about breast density will increase
exponentially starting this fall. It’s our hope that one day, these
conversations will include a discussion about (Z)-endoxifen and its
ability to safely reduce both breast density and the increased risk
that women with dense breasts have of developing breast cancer. We
look forward to seeing data from the Karisma-Endoxifen study in the
second half of this year and using it to further our discussions
with regulatory authorities and our plans for a Phase 3
registrational study.
Late last year we announced a second breast cancer prevention
study, which is investigating (Z)-endoxifen in women diagnosed with
Ductal Carcinoma In Situ (DCIS). Participants receive six months of
treatment with the intent of determining their suitability for
long-term active surveillance without surgery. This study is led by
Quantum Leap Healthcare Collaborative, which was established in
2005 by medical researchers at University of California, San
Francisco and Silicon Valley entrepreneurs to speed the development
of innovative breast cancer therapies like (Z)-endoxifen.
DCIS is the presence of abnormal cells inside a milk duct in the
breast. It’s considered the earliest form of breast cancer and is
noninvasive, meaning it hasn't spread beyond the milk duct. DCIS is
usually found during a mammogram done as part of breast cancer
screening or to investigate a breast lump. There are approximately
63,000 DCIS diagnoses made each year in the United States
alone.
Although the exact percentage is not known, it’s estimated about
20-50% of DCIS cases progress to invasive breast cancer if left
untreated. This presents a major clinical dilemma because with no
way to predict which lesions are destined to progress, aggressive
local therapy, identical to the way invasive breast cancer is
treated, is the current standard of care. For most patients, this
involves mastectomy or lumpectomy, radiation, and hormone therapy
for five years.
The key to reducing overtreatment is to identify biomarkers that
reflect the risk of progression, which is a key element of this
study. DCIS patients with a lower risk of progression would be
strong candidates for neoadjuvant endocrine therapy. This could
potentially spare a significant percentage of patients diagnosed
with DCIS from undergoing aggressive, invasive, unnecessary
treatment.
In the continuum of invasive breast cancer, our mammographic
breast density and DCIS trials are prevention studies. We also have
two ongoing Phase 2 trials investigating (Z)-endoxifen in the
neoadjuvant treatment setting, which is the window of time between
the diagnosis and the primary treatment. The intent of neoadjuvant
therapy is to slow the growth of the cancer or even shrink the
cancer prior to surgery. Doing this makes surgery more effective
and could alter the surgical approach; meaning some breast cancer
patients could have a lumpectomy instead of a mastectomy.
Neoadjuvant therapy has also been shown to reduce the likelihood
that the cancer returns.
Both of our neoadjuvant trials are enrolling patients with newly
diagnosed estrogen receptor-positive (ER+) invasive breast cancer.
The smaller study will enroll 20 patients and is another
partnership with Quantum Leap through their I-Spy network, which is
the largest and most successful platform trial in the world.
Patients in the (Z)-endoxifen arm are treated with 10mg daily for
up to 24 weeks prior to surgery. The (Z)-endoxifen treatment cohort
is expected to fully enroll the first quarter of 2024, which means
we should see data the second half of this year.
Our EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study is
much larger with an enrollment target of 175 patients. Another
important distinction is that patients in the EVANGELINE study are
being treated with a higher daily dose of (Z)-endoxifen. As we
communicated last year, the study commenced with a 40mg
pharmacokinetic (PK) run-in cohort. While the 40mg/day dose was
well tolerated and showed encouraging efficacy, it did not achieve
plasma concentrations to optimally target protein kinase C beta
(PKC-β) inhibition. We have since opened an 80mg PK cohort, which
we strongly believe will deliver the desired steady-state plasma
concentrations and further enhance (Z)-endoxifen’s antitumor
mechanism of action.
We know that (Z)-endoxifen binds to estrogen receptors in breast
cells and stops the body’s own natural estrogen from attaching to
them. We also know that (Z)-endoxifen has estrogen receptor
degrader characteristics, meaning it can both block and destroy the
receptor. This cuts off the cancer’s fuel source and prevents it
from growing and spreading, which alone is incredibly powerful, but
the significance of additionally targeting PKC-β cannot be
overstated.
The opportunity here is to induce apoptosis, which is programmed
cell death where the malignant cells are in a way, committing
suicide. It’s the cellular equivalent of a self-destruct button and
where we expect to see a reduction in the size of the tumor and
potentially pathologic complete response (pCR), which is defined as
the absence of residual invasive cancer upon evaluation of the
resected breast tissue and regional lymph nodes. Multiple
neoadjuvant studies in breast cancer have shown that pCR is
associated with a reduction in disease recurrence and improved
overall survival, two endpoints that the FDA highly values when
reviewing regulatory submissions for oncology indications.
Endoxifen’s ability to induce apoptosis was explored in detail
in a recent paper published in npj Breast Cancer, which is a Nature
Portfolio journal published by Springer Nature in partnership with
Breast Cancer Research Foundation (BCRF). The paper, titled
“Endoxifen downregulates AKT phosphorylation through protein kinase
C beta 1 inhibition in ERα+ breast cancer,” can be found here -
https://www.nature.com/articles/s41523-023-00606-2.
One of the authors is Dr. Matthew Goetz who is deputy director
of translational research for the Mayo Clinic Comprehensive Cancer
Center and co-leader of the Mayo Clinic Women's Cancer Program. Dr.
Goetz is also the primary investigator of our EVANGELINE study and
has more experience with endoxifen, in the lab and treating
patients, than anyone in the world.
Beyond the progress made in our four ongoing Phase 2 studies
this year, we also initiated important research with Weill Cornell
Medicine to study the potential of inducing estrogen receptor
expression in triple-negative breast cancer (TNBC). TNBC accounts
for about 10-15% of all breast cancers and it differs from other
types of invasive breast cancer in that it tends to grow and spread
faster, has fewer treatment options, has a higher risk of
recurrence, and tends to have a worse prognosis.
The goal of the research we are doing with Weill Cornell is to
determine if treating TNBC with extracellular vesicles carrying the
estrogen receptor will change the cancer phenotype and turn on the
estrogen receptor. Converting the tumor to ER+ would make it
sensitive to hormone therapy, including treatment with
(Z)-endoxifen. This would fundamentally transform the treatment
approach and outlook for these patients.
As important as 2023 was for our Company, 2024 promises to be an
opportunity for unparalleled progress. Fortunately, we are well
positioned to take advantage of the opportunities that lie ahead.
We have an extremely talented team in place and a growing network
of investigators and partners who share our belief that
(Z)-endoxifen has the potential to play an important role in both
the prevention and treatment of breast cancer. We also have a
strong balance sheet with no debt and cash, cash equivalents and
restricted cash of $94 million as of September 30, 2023.
As we consider our cash position, we remain intently focused on
deploying capital to drive long-term value for stockholders, which
is why in June of last year we announced a share repurchase program
with authorization to purchase up to $10 million of our common
stock through December 31, 2023. Through that program, we purchased
1.32 million shares of our stock at a cost of $1.475 million in
2023.
As we continue to believe that our current share price and the
long-term prospects of our business present an attractive and
strategic buying opportunity, the Atossa Board of Directors
recently extended the share repurchase program authorization
through December 31, 2024. The authorization continues to be for
the purchase up to $10 million of our common stock, inclusive of
purchases made in 2023.
On behalf of the board of directors, management, and employees
of Atossa Therapeutics, we thank you for your investment and
continued support of our Company.
Sincerely,
Steven C. Quay, MD, Ph.D.President and Chief Executive
Officer
About (Z)-Endoxifen(Z)-endoxifen is the most
active metabolite of the FDA approved Selective Estrogen Receptor
Modulator (SERM), tamoxifen. Studies by others have demonstrated
that the therapeutic effects of tamoxifen are driven in a
concentration-dependent manner by (Z)-endoxifen. In addition to its
potent anti-estrogen effects, (Z)-endoxifen at higher
concentrations has been shown to target PKCβ1, a known oncogenic
protein.
Atossa is developing a proprietary oral formulation of
(Z)-endoxifen that does not require liver metabolism to achieve
therapeutic concentrations and is encapsulated to bypass the
stomach as acidic conditions in the stomach convert a greater
proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s
(Z)-endoxifen has been shown to be well tolerated in Phase 1
studies and in a small Phase 2 study of women with breast cancer.
(Z)-endoxifen is currently being studied in four Phase 2 trials:
one in healthy women with measurable breast density, one in women
diagnosed with ductal carcinoma in situ, and two other studies
including the EVANGELINE study in women with ER+/HER2- breast
cancer. Atossa’s (Z)-endoxifen is protected by three issued U.S.
patents and numerous pending patent applications.
About Atossa TherapeuticsAtossa Therapeutics,
Inc. is a clinical-stage biopharmaceutical company developing
innovative medicines in areas of significant unmet medical need in
oncology with a focus on breast cancer. For more information,
please visit www.atossatherapeutics.com
ContactEric Van ZantenVP, Investor and Public
Relations610-529-6219eric.vanzanten@atossainc.com
FORWARD LOOKING STATEMENTSThis press release
contains certain information that may constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. We may identify these forward-looking
statements by the use of words such as “expect,” “potential,”
“continue,” “may,” “will,” “should,” “could,” “would,” “seek,”
“intend,” “plan,” “estimate,” “anticipate,” “believe,” “future,” or
other comparable words. Forward-looking statements in this press
release are subject to risks and uncertainties that may cause
actual results, outcomes, or the timing of actual results or
outcomes, to differ materially from those projected or anticipated,
including risks and uncertainties associated with: macroeconomic
conditions and increasing geopolitical instability; the expected
timing of releasing data; any variation between interim and final
clinical results; actions and inactions by the FDA and foreign
regulatory bodies; the outcome or timing of regulatory approvals
needed by Atossa, including those needed to continue our planned
(Z)-endoxifen trials; our ability to satisfy regulatory
requirements; our ability to regain compliance with the continued
listing requirements of the Nasdaq Stock Market; our ability to
successfully develop and commercialize new therapeutics; the
success, costs and timing of our development activities, including
our ability to successfully initiate or complete our clinical
trials, including our (Z)-endoxifen trials; our anticipated rate of
patient enrollment; our ability to contract with third-parties and
their ability to perform adequately; our estimates on the size and
characteristics of our potential markets; our ability to
successfully defend litigation and other similar complaints and to
establish and maintain intellectual property rights covering our
products; whether we can successfully complete our clinical trial
of oral (Z)-endoxifen in women with mammographic breast density and
our trials of (Z)-endoxifen in women with breast cancer, and
whether the studies will meet their objectives; our expectations as
to future financial performance, expense levels and capital
sources, including our ability to raise capital; our ability to
attract and retain key personnel; our anticipated working capital
needs and expectations around the sufficiency of our cash reserves;
and other risks and uncertainties detailed from time to time in
Atossa’s filings with the Securities and Exchange Commission,
including without limitation its Annual Reports on Form 10-K and
Quarterly Reports on 10-Q. Forward-looking statements are presented
as of the date of this press release. Except as required by law, we
do not intend to update any forward-looking statements, whether as
a result of new information, future events or circumstances or
otherwise.
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