Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company seeking to discover and 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 ended March 31, 2021, and
provides an update on recent company developments.
Key developments from Q1 2021 and to date include:
- Atossa concluded its open-label Phase 2 clinical study of oral
Endoxifen administered in the “window of opportunity” between
diagnosis of breast cancer and surgery based on positive results
allowing acceleration of the Endoxifen program in the United
States
- Announced updated findings following 24 months of an Expanded
Access (or “compassionate use”) single-patient study of Endoxifen
for breast cancer. The patient in the study had no cancer
recurrence and suffered no side effects. Endoxifen did not cause
other safety and tolerability concerns in this patient
- Received a “Safe to Proceed” letter under the Expanded
Access Pathway from the FDA permitting the use of Atossa’s oral
Endoxifen as a treatment in an ovarian cancer patient and began
treatment
- Announced final results from its Phase 1 double-blinded,
randomized, placebo-controlled clinical study using Atossa’s
proprietary drug candidate AT-301 administered by nasal spray.
AT-301 was considered to be safe and well tolerated in healthy male
and female participants in this study at two different dose levels
over 14 days. AT-301 is being developed for at home use for
patients recently diagnosed with COVID-19
- Completed financing transactions with net proceeds of
approximately $136 million beginning in December 2020 through the
end of Q1
Atossa’s 2021 Annual Stockholder Meeting is scheduled for today,
May 14, 2021 at 1 p.m. Pacific Time. As part of the meeting, Atossa
management has decided to withdraw from consideration the proposal
to increase authorized shares of common stock by 325 million.
“During the first quarter of 2021 we continued our two key
development programs, namely our Phase 2 study of oral Endoxifen
for the ‘window of opportunity’ between diagnosis of breast cancer
and surgery and our Phase 1 study of AT-301 nasal spray for at-home
use for patients recently diagnosed with COVID-19,” said Dr. Steven
Quay, Atossa’s President and Chief Executive Officer. “In addition,
we continued our ongoing expanded access program with Endoxifen in
which the drug continues to be well tolerated and breast cancer
recurrence has not been seen clinically. We also received an
important authorization from the FDA for an additional expanded
access treatment program in an ovarian cancer patient. Combined
with very encouraging results in our COVID-19 program with AT-301
nasal spray, we continued to make great progress over the
quarter.”
“In the meantime, we leveraged favorable conditions in the
capital markets to strengthen our balance sheet over the last few
months placing Atossa in a good position to execute on these and
potential additional business opportunities during the remainder of
2021. As a result, we are diligently moving our existing programs
forward, while actively exploring the possibility for strategic
expansion into other areas where we might see near-term milestones
and results. We look forward to continuing to update our
stockholders on these opportunities as they develop,” concluded Dr.
Quay.
Quarter Ended March 31, 2021 Financial
Results
For the quarter ended March 31, 2021, Atossa has no source of
sustainable revenue and no associated cost of revenue.
As of March 31, 2021, the Company had cash, cash
equivalents and restricted cash of approximately
$137.7 million.
Operating Expenses Total operating expenses were $3,531,000 for
the quarter ended March 31, 2021, compared to $2,937,000 during the
same period of 2020, an increase of $594,000 or approximately 20%.
Operating expenses for 2021 consisted of research and
development ("R&D") expenses of $1,379,000 and general and
administrative ("G&A") expenses of $2,152,000. Operating
expenses for 2020 consisted of R&D expenses of $939,000,
and G&A expenses of $1,998,000.
Research and Development ExpensesR&D expenses for the three
months ended March 31, 2021, were $1,379,000, an increase
of $440,000 or 47% from total R&D expenses for the same period
in 2020 of $939,000. The increase in R&D expense is
attributed primarily an increase in clinical trial expense of
approximately $319,000 and an increase in salaries of
approximately $118,000 due to the addition of employees, as
compared to the same period in 2020. We expect our R&D expenses
to continue to increase into 2021 as we seek to commence a
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 ExpensesG&A expenses were
$2,152,000 for the three months ended March 31, 2021, an
increase of $154,000, or 8% from the total G&A expenses for the
three months ended March 31, 2020, of $1,998,000. The
increase in G&A expenses for the three months ended
March 31, 2021, is mainly attributed to an increase
in insurance and professional fees of approximately $286,000 offset
by a reduction in legal fees and compensation of approximately
$152,000 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 Counsel Office: (866) 893-4927 kyle.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 March 31, |
|
|
|
As of |
|
|
|
2021 |
|
|
December 31, |
|
Assets |
|
(Unaudited) |
|
|
2020 |
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
137,573,593 |
|
|
$ |
39,553,671 |
|
Restricted cash |
|
|
110,000 |
|
|
|
110,000 |
|
Prepaid expenses |
|
|
2,550,452 |
|
|
|
1,813,902 |
|
Research and development tax rebate receivable |
|
|
720,029 |
|
|
|
634,940 |
|
Other current assets |
|
|
77,239 |
|
|
|
657,662 |
|
Total current assets |
|
|
141,031,313 |
|
|
|
42,770,175 |
|
|
|
|
|
|
|
|
|
|
Furniture and equipment, net |
|
|
15,835 |
|
|
|
20,632 |
|
Intangible assets, net |
|
|
8,917 |
|
|
|
13,375 |
|
Right-of-use asset |
|
|
8,013 |
|
|
|
18,053 |
|
Other assets |
|
|
16,468 |
|
|
|
17,218 |
|
Total Assets |
|
$ |
141,080,546 |
|
|
$ |
42,839,453 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
722,281 |
|
|
$ |
1,588,613 |
|
Accrued expenses |
|
|
151,155 |
|
|
|
93,367 |
|
Payroll liabilities |
|
|
490,001 |
|
|
|
963,665 |
|
Common stock warrant
liability |
|
|
- |
|
|
|
13,003,075 |
|
Lease liability |
|
|
8,013 |
|
|
|
18,053 |
|
Other current liabilities |
|
|
7,697 |
|
|
|
4,748 |
|
Total current liabilities |
|
|
1,379,147 |
|
|
|
15,671,521 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Preferred stock - $0.001 par value; 10,000,000 shares authorized;
620 and 621 shares issued and outstanding as of March 31, 2021 and
December 31, 2020, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital - Series B convertible preferred
stock |
|
|
619,999 |
|
|
|
620,999 |
|
Common stock - $0.18 par value; 175,000,000 shares authorized;
120,824,368 and 47,548,835 shares issued and outstanding as of
March 31, 2021 and December 31, 2020, respectively |
|
|
21,748,374 |
|
|
|
8,558,778 |
|
Additional paid-in capital |
|
|
229,498,725 |
|
|
|
129,887,146 |
|
Accumulated deficit |
|
|
(112,165,700 |
) |
|
|
(111,898,992 |
) |
Total Stockholders' Equity |
|
|
139,701,399 |
|
|
|
27,167,932 |
|
Total Liabilities and Stockholders' Equity |
|
$ |
141,080,546 |
|
|
$ |
42,839,453 |
|
ATOSSA THERAPEUTICS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(UNAUDITED)
|
|
For the Three Months Ended March 31, |
|
|
|
2021 |
|
|
2020 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,378,487 |
|
|
$ |
938,620 |
|
General and
administrative |
|
|
2,152,241 |
|
|
|
1,998,389 |
|
Total operating expenses |
|
|
3,530,728 |
|
|
|
2,937,009 |
|
Operating loss |
|
|
(3,530,728 |
) |
|
|
(2,937,009 |
) |
Other expense |
|
|
(7,341 |
) |
|
|
(10,411 |
) |
Loss before income taxes |
|
|
(3,538,069 |
) |
|
|
(2,947,420 |
) |
Income taxes |
|
|
- |
|
|
|
- |
|
Net loss |
|
$ |
(3,538,069 |
) |
|
$ |
(2,947,420 |
) |
Loss per common share - basic
and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.32 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
92,587,168 |
|
|
|
9,130,984 |
|
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