Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company seeking to develop innovative medicines
in oncology and infectious disease with a current focus on breast
cancer and COVID-19, today announces financial results for the
fiscal quarter and fiscal year ended December 31, 2021 and provides
an update on recent company developments.
Key developments from Q4 2021 and to date include:
- Initiated enrollment of our Phase 2 clinical study of
proprietary oral Z-endoxifen (or “Endoxifen”) in Sweden.
Participants in the study will be premenopausal women with
measurable mammographic breast density.
- Completed a pre-investigational new drug (PIND) meeting with
the FDA. The purpose of the meeting was to obtain input from the
FDA on pre-clinical, clinical, manufacturing and regulatory matters
in the U.S. for Atossa’s proprietary Endoxifen to treat breast
cancer in the neoadjuvant (prior to surgery) setting.
- Completed enrollment of Part A of our Phase 1/2a clinical study
of AT-H201 in Australia, consisting of single ascending dose
cohorts in healthy participants. 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, subject to future
studies in this patient population.
“We continue to make significant progress on our Endoxifen and
COVID-19 programs, with the continuation of enrollment of the
Australian trial for AT-H201, as well as enrollment in our Swedish
Endoxifen Phase 2 trial. We look forward to moving into the next
milestones during 2022, and to providing updates on these
developing therapies for urgent unmet patient needs. 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,” said Dr. Steven Quay, Atossa’s President and Chief
Executive Officer.
The Company’s upcoming plans with its current programs include
the following:
- Endoxifen neoadjuvant program: Atossa plans to submit to the
FDA an IND to conduct a Phase 2 study in the U.S. to compare
Endoxifen to standard of care in premenopausal women with breast
cancer. It will conduct a pharmacokinetic run-in study as a part of
the Phase 2 study to further define potential dose levels. 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 design and
manage the study. Atossa anticipates submitting an IND in the
second quarter of 2022 and then promptly commencing a Phase 2 study
in this neoadjuvant setting, assuming FDA acceptance.
- Endoxifen for women with measurable breast density: The Company
will continue to enroll participants in its Endoxifen Phase 2
clinical study in Stockholm.
- COVID-19 therapies under development: With respect to the
ongoing AT-H201 Phase 1/2a clinical study, Atossa plans to complete
enrollment in the second part in the second quarter 2022 and
complete the third part of the study in the third quarter 2022. In
2022, the Company plans to continue the additional pre-clinical
testing on its nasal spray AT-301 and then to further characterize
the API in AT-301 starting in the third quarter 2022.
Year Ended December 31, 2021, Financial
Results (in thousands)
As of December 31, 2021, we had cash, cash equivalents and
restricted cash of $136 million.
For the years ended December 31, 2021 and 2020, we have no
source of sustainable revenue and no associated cost of
revenue.
Operating Expenses: Total operating expenses were
$20,521 for the year ended December 31, 2021, which is an
increase of $5,914, or 40% from the year ended December 31,
2020. Operating expenses for 2021 consisted of research and
development (R&D) expenses of $9,210 and general and
administrative (G&A) expenses of $11,311. Operating expenses
for 2020 consisted of R&D expenses of $6,608 and G&A
expenses of $7,999. The basis for the increased operating
expenses in 2021 is explained
below. Research and Development Expenses:
R&D expenses for the year ended December 31, 2021, were $9,210,
an increase of $2,602 or 39% from total R&D expenses for
the year ended December 31, 2020, of $6,608. The increase in
R&D expense is attributed to increased spending on clinical and
non-clinical trials of $422 over 2020 due to additional
pre-clinical testing and manufacturing expenses for
Endoxifen. Stock-based compensation, which is a non-cash
charge, increased $693 year over year. R&D
compensation was also up $227 due to salary, bonus
and benefit increases during 2021. 2021 R&D expenses
also include a $1,000 exclusivity payment for the exclusive
right to negotiate with a leading research organization for
the rights to two oncology programs. There were no similar
exclusivity payments made during 2020. The remaining increase is
due to increased spending on professional fees in 2021 as
compared to 2020, due to the hiring of regulatory consultants and
other vendors.
General and Administrative Expenses: G&A expenses were
$11,311 for the year ended December 31, 2021, an increase of
$3,312, or 41% from total G&A expenses for the year ended
December 31, 2020, of $7,999. The increase in G&A expenses
for the year ended December 31,
2021, is attributable to non-cash stock-based
compensation expense of $1,555. Compensation also
increased $460 due to the addition of a new employee
during 2021, increased hourly employees time, and employee
bonus increases over the prior year. Insurance expense has
also increased $668 due to the addition of the COVID-19
program year over year. Professional fees have also
increased $897 due primarily to an increase of proxy
costs for investor outreach on a proposal to increase authorized
shares, expenses related to a special stockholder meeting and
increased consulting and auditing fees. Legal
fees decreased $360 year over year due to lower patent
activity in 2021.
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 and continue 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.CONSOLIDATED BALANCE
SHEETS(amounts in thousands, except for par
value)
|
|
As of December 31, |
|
Assets |
|
2021 |
|
|
2020 |
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
136,377 |
|
|
$ |
39,554 |
|
Restricted cash |
|
|
110 |
|
|
|
110 |
|
Prepaid expenses |
|
|
2,488 |
|
|
|
1,814 |
|
Research and development tax rebate receivable |
|
|
1,072 |
|
|
|
635 |
|
Other current assets |
|
|
1,193 |
|
|
|
657 |
|
Total current assets |
|
|
141,240 |
|
|
|
42,770 |
|
|
|
|
|
|
|
|
|
|
Furniture and equipment, net |
|
|
20 |
|
|
|
21 |
|
Intangible assets, net |
|
|
- |
|
|
|
13 |
|
Right-of-use asset |
|
|
- |
|
|
|
18 |
|
Other assets |
|
|
2 |
|
|
|
17 |
|
Total Assets |
|
$ |
141,262 |
|
|
$ |
42,839 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,717 |
|
|
$ |
1,589 |
|
Accrued expenses |
|
|
204 |
|
|
|
93 |
|
Payroll liabilities |
|
|
1,184 |
|
|
|
964 |
|
Common stock warrant liability |
|
|
- |
|
|
|
13,003 |
|
Lease liability |
|
|
- |
|
|
|
18 |
|
Other current liabilities |
|
|
21 |
|
|
|
4 |
|
Total current liabilities |
|
|
3,126 |
|
|
|
15,671 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
3,126 |
|
|
|
15,671 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Preferred stock - $0.001 par value; 10,000 shares authorized; 1
share issued and outstanding as of December 31, 2021 and December
31, 2020, respectively |
|
|
- |
|
|
|
- |
|
Additional paid-in capital - Series B convertible preferred
stock |
|
|
582 |
|
|
|
621 |
|
Common stock - $0.18 par value; 175,000 shares authorized; 126,624
and 47,550 shares issued and outstanding as of December 31, 2021
and December 31, 2020, respectively |
|
|
22,792 |
|
|
|
8,559 |
|
Additional paid-in capital |
|
|
243,996 |
|
|
|
129,887 |
|
Accumulated deficit |
|
|
(129,234 |
) |
|
|
(111,899 |
) |
Total Stockholders' Equity |
|
|
138,136 |
|
|
|
27,168 |
|
Total Liabilities and Stockholders' Equity |
|
$ |
141,262 |
|
|
$ |
42,839 |
|
ATOSSA THERAPEUTICS,
INC.CONSOLIDATED STATEMENTS OF
OPERATIONS(amounts in thousands, except for per
share amounts)
|
|
For the Year Ended December 31, |
|
|
|
|
|
|
|
|
|
|
|
|
2021 |
|
|
2020 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
9,210 |
|
|
$ |
6,608 |
|
General and
administrative |
|
|
11,311 |
|
|
|
7,999 |
|
Total operating expenses |
|
|
20,521 |
|
|
|
14,607 |
|
Operating loss |
|
|
(20,521 |
) |
|
|
(14,607 |
) |
Change in fair value of common
stock warrants |
|
|
- |
|
|
|
(2,333 |
) |
Warrant financing expense |
|
|
- |
|
|
|
(939 |
) |
Other (expense) income,
net |
|
|
(85 |
) |
|
|
51 |
|
Loss before income taxes |
|
|
(20,606 |
) |
|
|
(17,828 |
) |
Income taxes |
|
|
- |
|
|
|
- |
|
Net loss |
|
$ |
(20,606 |
) |
|
$ |
(17,828 |
) |
Deemed dividend attributable
to preferred stock |
|
|
- |
|
|
|
(4,503 |
) |
Net loss applicable to common
shareholders |
|
$ |
(20,606 |
) |
|
$ |
(22,331 |
) |
Loss per common share - basic
and diluted |
|
$ |
(0.18 |
) |
|
$ |
(1.97 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
116,950 |
|
|
|
11,309 |
|
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