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 September 30, 2021, and provides an
update on recent company developments.
Key developments from Q3 2021 and to date
include:
- Began to enroll participants in its clinical study of AT-H201
in Australia. The nebulized formulation, AT-H201, is being
developed as an inhalation therapy for moderately to severely ill
hospitalized COVID-19 patients and for “long-haul” patients with
post-infection pulmonary disease.
- Received authorization from Swedish regulators to initiate a
Phase 2 clinical study of Endoxifen to assess safety and
pharmacodynamics in women with mammographic breast density
(MBD).
- Scheduled a pre-IND meeting with the U.S. FDA to obtain input
on the potential clinical and regulatory pathway for use of
Atossa’s Endoxifen to treat breast cancer patients in the
neoadjuvant (sometimes called “window of opportunity”) setting. The
meeting is currently scheduled for December 2021.
“Our progress in both the Endoxifen and COVID-19
programs, with our initiation of our trial in Australia for
AT-H201, and our receipt of regulatory authorization in Sweden to
commence an Endoxifen Phase 2 trial, have been key recent
milestones, positioning us to move both of these programs forward
and take the next steps toward developing therapies in urgent unmet
patient needs,” said Dr. Steven Quay, Atossa’s President and Chief
Executive Officer.
“Further, our strong balance sheet will continue to
facilitate our development plans as we not only execute on these
trials but also explore additional options that could create
significant shareholder value,” concluded Dr. Quay.
Quarter Ended September 30, 2021, Financial
Results
For the quarter ended September 30, 2021, Atossa
has no source of sustainable revenue and no associated cost of
revenue.
As of September 30, 2021, the Company had cash,
cash equivalents and restricted cash of approximately $140
million.
Operating Expenses: Total
operating expenses were approximately $5,159,000 and $15,693,000
for the three and nine months ended September 30,
2021, respectively, consisting of research and development
("R&D") expenses of approximately $2,206,000 and $7,383,000
respectively, and general and administrative ("G&A") expenses
of approximately $2,952,000 and $8,310,000, respectively. Total
operating expenses were approximately $3,509,000 and $10,382,000,
respectively for the three and nine month ended
September 30, 2020, and consisted of R&D expenses of
approximately $1,659,000 and $4,251,000, respectively, and
G&A expenses of approximately $1,850,000 and
$6,131,000 respectively. Total operating expenses for the
three and nine months ended September 30, 2021 as
compared to the same period in 2020 increased approximately
$1,650,000 and $5,311,000 or 47% and 51%, respectively.
The basis for the increased operating expenses in 2021 is
explained below.
Research and Development
Expenses: R&D expenses for the three months ended
September 30, 2021, were approximately $2,206,000, an increase
of approximately $547,000 or 33% from total R&D expenses
for the three months ended September 30, 2020, of
approximately $1,659,000. The increase of approximately
$547,000 for the three month period is attributed to an increase in
clinical trial expense of approximately $81,000, an increase in
compensation of approximately $380,000 driven by non-cash
stock-based compensation and an increase in R&D professional
fees of approximately $82,000. R&D expenses for the
nine months ended September 30, 2021, were approximately
$7,383,000, an increase of approximately $3,132,000 or 74%
from total R&D expenses for the nine months ended
September 30, 2020, of approximately $4,251,000. The
increase in R&D expense for the nine months ended September 30,
2021, is attributed primarily to an increase in clinical trial
expense of approximately $1,390,000 and an increase in
compensation of approximately $591,000 due primarily to
non-cash stock-based compensation and the addition of
two employees, as compared to the same period in 2020. Also
included in R&D expenses is an increase of
$1,000,000 attributable to a one-time fee we paid in June 2021
to a U.S. leading research institution for the exclusive
right to negotiate for the acquisition of the world-wide rights to
two oncology R&D programs. Those negotiations are ongoing,
and no assurance can be given that they will lead to a definitive
agreement. We expect our R&D expenses to continue to
increase through 2021 as we have commenced a clinical
study of AT-H201, complete studies of AT-301,
launch a Phase 2 clinical trial of Endoxifen in women
with high breast density, and continue the development of other
indications and therapeutics.
General and Administrative
Expenses: G&A expenses were approximately $2,952,000 for the
three months ended September 30, 2021, an increase of
approximately $1,102,000, or 60% from the total G&A expenses
for the three months ended September 30, 2020, of
approximately $1,850,000. The increase of approximately $1,102,000
for the three-month period is attributed to an increase in
insurance costs of approximately $192,000 due to additional
COVID-19 clinical trials and an increase in compensation of
approximately $900,000 due primarily to non-cash stock-based
compensation. G&A expenses for the nine months ended
September 30, 2021, were approximately $8,310,000, an increase of
approximately $2,179,000 or 36% from total G&A expenses
for the nine months ended September 30, 2020, of
approximately $6,131,000. The increase in G&A expenses for
the nine months ended September 30, 2021, is
attributed to an increase in insurance costs of approximately
$578,000 due to the addition of the COVID-19 clinical
trials, professional fees of approximately $742,000 due
primarily to increased proxy costs and increased compensation
of approximately $1,070,000 resulting primarily from increased
headcount and increased non-cash stock-based
compensation, offset by a reduction in legal fees of
approximately $343,000 compared to the same period in 2020. G&A
expenses consist primarily of personnel and related benefit costs,
facilities, professional services, insurance, and public company
related expenses.
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
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2021 |
|
|
As of December 31, |
|
Assets |
|
(Unaudited) |
|
|
2020 |
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
140,040,955 |
|
|
$ |
39,553,671 |
|
Restricted cash |
|
|
110,000 |
|
|
|
110,000 |
|
Prepaid expenses |
|
|
1,883,197 |
|
|
|
1,813,902 |
|
Research and development tax rebate receivable |
|
|
934,672 |
|
|
|
634,940 |
|
Other current assets |
|
|
18,060 |
|
|
|
657,662 |
|
Total current assets |
|
|
142,986,884 |
|
|
|
42,770,175 |
|
|
|
|
|
|
|
|
|
|
Furniture and equipment, net |
|
|
22,138 |
|
|
|
20,632 |
|
Intangible assets, net |
|
|
- |
|
|
|
13,375 |
|
Right-of-use asset |
|
|
1,217 |
|
|
|
18,053 |
|
Other assets |
|
|
13,408 |
|
|
|
17,218 |
|
Total Assets |
|
$ |
143,023,647 |
|
|
$ |
42,839,453 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
667,988 |
|
|
$ |
1,588,613 |
|
Accrued expenses |
|
|
75,695 |
|
|
|
93,367 |
|
Payroll liabilities |
|
|
912,670 |
|
|
|
963,665 |
|
Common stock warrant liability |
|
|
- |
|
|
|
13,003,075 |
|
Lease liability |
|
|
1,217 |
|
|
|
18,053 |
|
Other current liabilities |
|
|
18,251 |
|
|
|
4,748 |
|
Total current liabilities |
|
|
1,675,821 |
|
|
|
15,671,521 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
1,675,821 |
|
|
|
15,671,521 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Preferred stock - $0.001 par value; 10,000,000 shares authorized;
584 and 621 shares issued and outstanding as of September 30, 2021
and December 31, 2020, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital - Series B convertible preferred
stock |
|
|
583,999 |
|
|
|
620,999 |
|
Common stock - $0.18 par value; 175,000,000 shares authorized;
126,623,541 and 47,548,835 shares issued and outstanding as of
September 30, 2021 and December 31, 2020, respectively |
|
|
22,792,225 |
|
|
|
8,558,778 |
|
Additional paid-in capital |
|
|
242,373,694 |
|
|
|
129,887,146 |
|
Accumulated deficit |
|
|
(124,402,093 |
) |
|
|
(111,898,992 |
) |
Total Stockholders' Equity |
|
|
141,347,826 |
|
|
|
27,167,932 |
|
Total Liabilities and Stockholders' Equity |
|
$ |
143,023,647 |
|
|
$ |
42,839,453 |
|
ATOSSA THERAPEUTICS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(UNAUDITED)
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,206,158 |
|
|
$ |
1,659,075 |
|
|
$ |
7,383,281 |
|
|
$ |
4,250,934 |
|
General and
administrative |
|
|
2,952,436 |
|
|
|
1,849,741 |
|
|
|
8,309,807 |
|
|
|
6,130,698 |
|
Total operating expenses |
|
|
5,158,594 |
|
|
|
3,508,816 |
|
|
|
15,693,088 |
|
|
|
10,381,632 |
|
Operating loss |
|
|
(5,158,594 |
) |
|
|
(3,508,816 |
) |
|
|
(15,693,088 |
) |
|
|
(10,381,632 |
) |
Other income (expense),
net |
|
|
(38,551 |
) |
|
|
17,745 |
|
|
|
(81,374 |
) |
|
|
36,999 |
|
Loss before income taxes |
|
|
(5,197,145 |
) |
|
|
(3,491,071 |
) |
|
|
(15,774,462 |
) |
|
|
(10,344,633 |
) |
Income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss |
|
$ |
(5,197,145 |
) |
|
$ |
(3,491,071 |
) |
|
$ |
(15,774,462 |
) |
|
$ |
(10,344,633 |
) |
Loss per common share - basic
and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.14 |
) |
|
$ |
(1.09 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
126,537,544 |
|
|
|
10,162,770 |
|
|
|
113,689,961 |
|
|
|
9,496,222 |
|
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