Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the
“Company”) today announced financial results for the fiscal quarter
ended March 31, 2024, and provides an update on recent company
developments. Atossa is a clinical stage biopharmaceutical company
developing innovative medicines in areas of significant unmet
medical need in oncology with a focus on breast cancer
Key developments from Q1 2024 and the year to date include:
- Presented data from 40mg pharmacokinetic run-in cohort
of ongoing EVANGELINE study at the AACR annual meeting –
data showed 100% disease control rate, 37% average MRI-based lesion
size decrease and a 92% reduction in Ki-67, at 24 weeks. Treatment
related toxicities included grade 3 headache (one patient), grade 2
amenorrhea (one patient), and grade 2 hot flashes (one patient).
There were no grade 4 or 5 treatment related toxicities.
- Initiated study evaluating (Z)-endoxifen in combination
with abemaciclib (VERZENIO®) – the study will enroll 20
women with newly diagnosed Estrogen Receptor positive (ER+) / Human
Epidermal Growth Factor Receptor 2 negative (HER2-) invasive breast
cancer. Participants will receive (Z)-endoxifen daily in
combination with abemaciclib, a cyclin-dependent kinase (CDK) 4/6
inhibitor marketed by Eli Lilly and Company, twice daily for a
total of 24 weeks prior to surgery.
- Expanded access patient concluded five-years of
(Z)-endoxifen treatment – the pre-menopausal, ER+ / HER2-,
breast cancer patient who received neoadjuvant and adjuvant
(Z)-endoxifen therapy under an FDA-approved "expanded access"
program completed five-years of successful treatment. The patient
remains cancer-free and reported no significant safety or
tolerability issues over the course of her treatment.
- Fully enrolled Phase 2 I-SPY 2 Clinical Trial
– (Z)-endoxifen is being evaluated as a neoadjuvant
treatment in a study arm of the ongoing I-SPY 2 clinical trial. The
study arm targets patients with newly diagnosed estrogen
receptor-positive breast cancer whose tumors are predicted to be
sensitive to endocrine therapy but for whom chemotherapy is
expected to provide little or no benefit. Full enrollment was
achieved in February 2024 and data is expected in the second half
of 2024.
- First patient dosed with (Z)-endoxifen in RECAST DCIS
study – the Re-Evaluating Conditions for Active
Surveillance Suitability as Treatment: Ductal Carcinoma In Situ
(RECAST DCIS) study is an ongoing Phase 2 platform study designed
to offer women diagnosed with DCIS six months of neoadjuvant
endocrine therapy with the intent of determining their suitability
for long-term active surveillance without surgery.
- Appointed Tessa Cigler, M.D., M.P.H to Atossa’s Board
of Directors – Dr. Cigler is a medical oncologist and
clinical investigator at the Weill Cornell Breast Center in New
York City. As a member of the Weill Cornell Breast Center research
team, she heads several clinical trials designed to provide her
patients with access to the new promising options for therapy and
supportive care.
“The first quarter of 2024 was a period of significant progress
for our Company,” said Steven Quay, M.D., Ph.D., Atossa’s President
and Chief Executive Officer. “We initiated a new combination study,
presented extremely promising monotherapy data at AACR and fully
enrolled the second of our five ongoing Phase 2 studies. Our focus
for the remainder of 2024 will be to continue driving our
(Z)-endoxifen development program forward, preparing for critical
data readouts expected in the second half of this year and further
progressing conversations with regulatory authorities and
prospective partners. Even with all of our significant
accomplishments in the quarter, our cash balance remains strong, at
$84.0 million.”
Comparison of Three Months Ended March 31, 2024 and
2023
Revenue and Cost of Revenue. For the three months ended March
31, 2024 and 2023, we had no source of revenue and no associated
cost of revenue.
Operating Expenses. Total operating expenses were $7.0 million
for the three months ended March 31, 2024, which was a decrease of
$0.1 million, from total operating expenses for the three months
ended March 31, 2023 of $7.1 million. Factors contributing to the
decreased operating expenses in the three months ended March 31,
2024 are explained below.
R&D Expenses. R&D expenses for the three months ended
March 31, 2024, were $3.7 million, an increase of $0.2 million from
R&D expenses for the three months ended March 31, 2023 of $3.5
million
The following table provides a breakdown of major categories
within R&D expense for the three months ended March 31 2024 and
2023, together with the dollar change in those categories (in
thousands):
|
|
|
For the Three Months Ended March 31, |
|
|
|
|
|
|
|
2024 |
|
|
2023 |
|
|
Increase (Decrease) |
|
Research and Development
Expense |
|
|
|
|
|
|
|
|
|
|
|
Clinical and non-clinical trials |
|
$ |
2,884 |
|
|
$ |
2,336 |
|
|
$ |
548 |
|
|
Compensation |
|
|
626 |
|
|
|
1,034 |
|
|
|
(408 |
) |
|
Professional fees and
other |
|
|
238 |
|
|
|
138 |
|
|
|
100 |
|
|
Research and
Development Expense Total |
|
$ |
3,748 |
|
|
$ |
3,508 |
|
|
$ |
240 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- The increase in R&D expense was primarily due to increased
spending on clinical and non-clinical trials of $0.5 million
compared to the prior year period for (Z)-endoxifen trials,
including drug development costs.
- The decrease in R&D compensation expense for the three
months ended March 31, 2024 compared to the prior year period was
primarily due to a decrease in non-cash stock-based compensation of
$0.4 million. Non-cash stock-based compensation decreased compared
to the prior year period due to the weighted average fair value of
options amortizing in 2024 being lower period over period.
- The increase in R&D professional fees of $0.1 million for
the three months ended March 31, 2024 compared to the prior year
period was primarily attributable to higher consulting fees in 2024
related to our endoxifen program.
General and Administrative (G&A) Expenses. G&A expenses
for the three months ended March 31, 2024 were $3.2 million, a
decrease of $0.4 million from total G&A expenses for the
three months ended March 31, 2023 of $3.6 million.
The following table provides a breakdown of major categories
within G&A expenses for the three months ended March 31, 2024
and 2023, together with the dollar change in those categories (in
thousands):
|
|
|
For the Three Months Ended March 31, |
|
|
|
|
|
|
|
2024 |
|
|
2023 |
|
|
Increase (Decrease) |
|
General and
Administrative Expense |
|
|
|
|
|
|
|
|
|
|
|
Compensation |
|
$ |
1,325 |
|
|
$ |
2,084 |
|
|
$ |
(759 |
) |
|
Professional fees and
other |
|
|
1,680 |
|
|
|
1,164 |
|
|
|
516 |
|
|
Insurance |
|
|
227 |
|
|
|
342 |
|
|
|
(115 |
) |
|
General and
Administrative Expense Total |
|
$ |
3,232 |
|
|
$ |
3,590 |
|
|
$ |
(358 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- The decrease in G&A compensation expense of $0.8 million
for the three months ended March 31, 2024 compared to the prior
year period was due to a decrease in non-cash stock-based
compensation of $0.8 million. Non-cash stock-based compensation
decreased compared to the prior year period due to the weighted
average fair value of options amortizing in 2024 being lower period
over period.
- The increase in G&A professional fees of $0.5 million for
the three months ended March 31, 2024 compared to the prior year
period was primarily due to an increase in legal fees for higher
patent-related activity.
- The decrease in G&A insurance expense of $0.1 million for
the three months ended March 31, 2024 compared to the prior year
period was due to lower negotiated insurance premiums for the same
or better coverage period over period.
Interest Income. Interest income was $1.1 million for the three
months ended March 31, 2024, an increase of $0.2 million from
interest income of $0.9 million for the three months ended March
31, 2023. The increase was due to a change in the mix of our money
market accounts which yielded a higher rate of return.
About (Z)-Endoxifen(Z)-endoxifen is the most
potent Selective Estrogen Receptor Modulator (SERM) for estrogen
receptor inhibition and also causes estrogen receptor degradation.
It has also been shown to have efficacy in the setting of patients
with tumor resistance to other hormonal treatments. In addition to
its potent anti-estrogen effects, (Z)-endoxifen has been shown to
target PKCβ1, a known oncogenic protein, at clinically attainable
blood concentrations. Finally, (Z)-endoxifen appears to deliver
similar or even greater bone agonistic effects while resulting in
little or no endometrial proliferative effects compared with
standard treatments, like tamoxifen.
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 significant
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 five 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 using (Z)-endoxifen to prevent and treat
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, such as data related to the (Z)-endoxifen program and the
potential of (Z)-endoxifen as a breast cancer prevention and
treatment agent, 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 remain compliant 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.
ATOSSA THERAPEUTICS, INC.CONSOLIDATED
BALANCE SHEETS(amounts in thousands, except share
and per share
data) |
|
|
|
March 31, 2024 |
|
|
December 31, 2023 |
|
Assets |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
83,960 |
|
|
$ |
88,460 |
|
Restricted cash |
|
|
110 |
|
|
|
110 |
|
Prepaid materials |
|
|
1,372 |
|
|
|
1,487 |
|
Prepaid expenses and other current assets |
|
|
1,613 |
|
|
|
2,162 |
|
Total current assets |
|
|
87,055 |
|
|
|
92,219 |
|
|
|
|
|
|
|
|
Investment in equity securities |
|
|
1,710 |
|
|
|
1,710 |
|
Other assets |
|
|
2,322 |
|
|
|
2,323 |
|
Total assets |
|
$ |
91,087 |
|
|
$ |
96,252 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,230 |
|
|
$ |
806 |
|
Accrued expenses |
|
|
1,613 |
|
|
|
973 |
|
Payroll liabilities |
|
|
659 |
|
|
|
1,654 |
|
Other current liabilities |
|
|
1,826 |
|
|
|
1,803 |
|
Total current liabilities |
|
|
5,328 |
|
|
|
5,236 |
|
Total liabilities |
|
|
5,328 |
|
|
|
5,236 |
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
Convertible preferred stock - $0.001 par value; 10,000,000 shares
authorized;582 shares issued and outstanding as of March 31, 2024
and December 31, 2023 |
|
|
— |
|
|
|
— |
|
Common stock - $0.18 par value; 175,000,000 shares authorized;
125,507,814 and 125,304,064 shares issued and outstanding as of
March 31, 2024 and December 31, 2023, respectively |
|
|
22,829 |
|
|
|
22,792 |
|
Additional paid-in capital |
|
|
256,571 |
|
|
|
255,987 |
|
Treasury stock, at cost; 1,320,046 shares of common stock
at March 31, 2024 and December 31, 2023 |
|
|
(1,475 |
) |
|
|
(1,475 |
) |
Accumulated deficit |
|
|
(192,166 |
) |
|
|
(186,288 |
) |
Total stockholders' equity |
|
|
85,759 |
|
|
|
91,016 |
|
Total liabilities and stockholders' equity |
|
$ |
91,087 |
|
|
$ |
96,252 |
|
ATOSSA THERAPEUTICS,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share and per share
data) |
|
|
|
For the Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
Operating expenses |
|
|
|
|
|
|
Research and development |
|
$ |
3,748 |
|
|
$ |
3,508 |
|
General and administrative |
|
|
3,232 |
|
|
|
3,590 |
|
Total operating expenses |
|
|
6,980 |
|
|
|
7,098 |
|
Operating loss |
|
|
(6,980 |
) |
|
|
(7,098 |
) |
Interest income |
|
|
1,138 |
|
|
|
850 |
|
Other expense, net |
|
|
(36 |
) |
|
|
(33 |
) |
Loss before income taxes |
|
|
(5,878 |
) |
|
|
(6,281 |
) |
Income tax benefit |
|
|
— |
|
|
|
— |
|
Net loss |
|
|
(5,878 |
) |
|
|
(6,281 |
) |
Net loss per share of common
stock - basic and diluted |
|
$ |
(0.05 |
) |
|
$ |
(0.05 |
) |
Weighted average shares
outstanding used to compute net loss per share - basic and
diluted |
|
|
125,319,778 |
|
|
|
126,624,110 |
|
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
Von Mai 2024 bis Jun 2024
Atossa Therapeutics (NASDAQ:ATOS)
Historical Stock Chart
Von Jun 2023 bis Jun 2024