Atossa Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Listing Requirements
July 13 2023 - 4:15PM
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 announced that on July 13, 2023 it received
written notice from The Nasdaq Stock Market LLC that it has
regained compliance with the minimum closing bid price requirement
under Nasdaq Listing Rule 5550(a)(2) for continued listing on The
Nasdaq Capital Market.
As previously disclosed, on October 5, 2022, the Company was
notified by Nasdaq that it was not in compliance with Nasdaq
Listing Rule 5550(a)(2) because its common stock failed to maintain
a minimum closing bid price of $1.00 per share for 30 consecutive
business days. The Company was initially given 180 days to regain
compliance. On April 4, 2023, the Company received a 180-day
extension.
To regain compliance, the Company was required to maintain a
minimum closing bid price of $1.00 per share for at least 10
consecutive trading days. This requirement was met on July 12,
2023. As a result, the Company’s common stock will continue to be
listed and traded on The Nasdaq Capital Market.
"We are pleased to have regained compliance with Nasdaq's
minimum bid price listing requirement," said Greg Weaver, Atossa’s
Chief Financial Officer. "We have made significant progress this
year with our (Z)-endoxifen development program and look forward to
seeing data from our Phase 2 trials in 2024. With over $100 million
cash, as reported on March 31, 2023, and no debt, we believe we
have a strong balance sheet and several years working capital,
which should allow us to complete our ongoing trials, prepare for
potential Phase 3 studies and remain opportunistic with respect to
business development."
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.
The Company is currently studying (Z)-endoxifen in three Phase 2
studies: one in healthy women with measurable breast density 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
Contact:Eric Van ZantenVP, Investor and Public
Relations610-529-6219eric.vanzanten@atossainc.com
FORWARD LOOKING STATEMENTSForward-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 the expected timing of releasing data, 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
(Z)-endoxifen, anticipated progress on Atossa’s (Z)-endoxifen
development program, 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 breast density or in Ki-67 or any other result from a
neoadjuvant study is an approvable endpoint for (Z)-endoxifen,
whether Atossa can complete acquisitions, anticipated working
capital needs and expectations around the sufficiency of our cash
reserves, 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.
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