Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company seeking to develop innovative proprietary
medicines in oncology and infectious disease with a current focus
on breast cancer and COVID-19, today announces financial results
for the fiscal quarter ended March 31, 2022, and provides an update
on recent company developments.
Key developments from Q1 2022 and to date include:
- Received issuance of key U.S. patent covering Endoxifen
directed to compositions of storage-stable Endoxifen and methods of
treating hormone-dependent breast disorders using the
storage-stable Endoxifen.
- Announced planned U.S. Phase 2 clinical study of Endoxifen in
the neoadjuvant setting (prior to surgery) to compare Endoxifen to
standard of care in premenopausal women with breast cancer. A CRO
has been engaged to work on this study and the Company also intends
to retain a leading U.S. research institution to help manage the
study. The Company anticipates submitting an IND to the FDA in the
second quarter of 2022.
- Completed Part B (second of four parts) of Phase 1b/2a clinical
study of AT-H201 in Australia
“We continue to make steady progress with our Endoxifen
programs: one to reduce tumor cell activity in breast cancer
patients in the neoadjuvant setting; and another to reduce dense
breast tissue in women,” commented Dr. Steven Quay, Atossa’s
President and Chief Executive Officer. “Our Phase 2 study in women
with measurable breast density continues to enroll participants in
Stockholm and we have been preparing to submit a request (IND) to
the FDA this quarter to open a Phase 2 study in the neoadjuvant
setting here in the Unites States. We began 2022 with significant
progress in our COVID-19 program, both initiating and completing
key parts of our Phase1b/2a trial in Australia for AT-H201, and we
have now completed the first two parts of that study.”
Quarter Ended March 31, 2022 Financial Results (in
thousands):
For the quarter ended March 31, 2022, Atossa has no source of
sustainable revenue and no associated cost of revenue.
As of March 31, 2022, the Company had cash, cash equivalents and
restricted cash of approximately $131,596.
Operating Expenses: Total operating expenses were
$4,747 for the three months ended March 31, 2022,
which is an increase of $1,216 or 34%, from the three
months ended March 31, 2021. Operating expenses for
2022 consisted of research and development (R&D) expenses
of $1,499 and general and administrative (G&A) expenses of
$3,248. Operating expenses for 2021 consisted of R&D
expenses of $1,379, and G&A expenses of $2,152.
Research and Development Expenses: R&D expenses for the
three months ended March 31, 2022, were $1,499, an
increase of $120 or 9% from total R&D expenses for the
same period in 2021 of $1,379. The increase in R&D
expense is attributed to increased spending on clinical and
non-clinical trials of $584 over 2021 due to additional drug
manufacturing costs. Stock-based compensation, which is a
non-cash charge, also increased $433 quarter over quarter, and
other R&D compensation was up $79 due to salary bonus and
benefit increases quarter over quarter. The increase in
R&D was offset by a refund of $1,000 from the research
institution that the Company had an exclusive right
to negotiate for the acquisition of the world-wide rights to
two oncology R&D programs. In February 2022, the other party
did not honor its obligation to negotiate with us which lead to a
cancellation of the agreement and refund of the $1,000 we paid
them.
General and Administrative Expenses: G&A expenses were
$3,248 for the three months ended March 31, 2022, an
increase of $1,096, or 51% from the total G&A expenses for the
three months ended March 31, 2021, of $2,152. The
increase in G&A expenses for the three months ended
March 31, 2022, is primarily attributable to non-cash
stock-based compensation expense of $734. Other compensation also
increased $264 due to the addition of a new employee quarter over
quarter as well as salary, bonus and benefit increases. Legal fees
also increased $124 quarter over quarter due to increased patent
activity.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical
company seeking to discover and develop innovative medicines 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
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 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
Source: Atossa Therapeutics, Inc.
ATOSSA THERAPEUTICS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(amounts in thousands, except for par
value)
|
|
As of March 31, |
|
|
|
|
|
|
|
2022 |
|
|
As of December 31, |
|
Assets |
|
(Unaudited) |
|
|
2021 |
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
131,486 |
|
|
$ |
136,377 |
|
Restricted cash |
|
|
110 |
|
|
|
110 |
|
Prepaid expenses |
|
|
3,874 |
|
|
|
2,488 |
|
Research and development rebate receivable |
|
|
668 |
|
|
|
1,072 |
|
Other current assets |
|
|
710 |
|
|
|
1,193 |
|
Total current assets |
|
|
136,848 |
|
|
|
141,240 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
630 |
|
|
|
22 |
|
Total Assets |
|
$ |
137,478 |
|
|
$ |
141,262 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,596 |
|
|
$ |
1,717 |
|
Accrued expenses |
|
|
120 |
|
|
|
204 |
|
Payroll liabilities |
|
|
593 |
|
|
|
1,184 |
|
Other current liabilities |
|
|
13 |
|
|
|
21 |
|
Total current liabilities |
|
|
2,322 |
|
|
|
3,126 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
2,322 |
|
|
|
3,126 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Preferred stock - $0.001 par value; 10,000 shares authorized; 1
share issued and outstanding as of March 31, 2022 and December 31,
2021 |
|
|
- |
|
|
|
- |
|
Additional paid-in capital - Series B convertible preferred
stock |
|
|
582 |
|
|
|
582 |
|
Common stock - $0.18 par value; 175,000 shares authorized; 126,624
shares issued and outstanding as of March 31, 2022 and December 31,
2021 |
|
|
22,792 |
|
|
|
22,792 |
|
Additional paid-in capital - common stock |
|
|
245,802 |
|
|
|
243,996 |
|
Accumulated deficit |
|
|
(134,020 |
) |
|
|
(129,234 |
) |
Total Stockholders' Equity |
|
|
135,156 |
|
|
|
138,136 |
|
Total Liabilities and Stockholders' Equity |
|
$ |
137,478 |
|
|
$ |
141,262 |
|
ATOSSA THERAPEUTICS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(UNAUDITED)(amounts in
thousands, except for per share amounts)
|
|
For the Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,499 |
|
|
$ |
1,379 |
|
General and
administrative |
|
|
3,248 |
|
|
|
2,152 |
|
Total operating expenses |
|
|
4,747 |
|
|
|
3,531 |
|
Operating loss |
|
|
(4,747 |
) |
|
|
(3,531 |
) |
Other expense, net |
|
|
(39 |
) |
|
|
(7 |
) |
Loss before income taxes |
|
|
(4,786 |
) |
|
|
(3,538 |
) |
Income taxes |
|
|
- |
|
|
|
- |
|
Net loss |
|
$ |
(4,786 |
) |
|
$ |
(3,538 |
) |
Loss per common share - basic
and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.04 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
126,624 |
|
|
|
92,587 |
|
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