Atossa Therapeutics Announces First Quarter 2020 Financial Results and Provides Company Update on COVID-19 HOPE and Endoxifen...
May 13 2020 - 9:30AM
Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company seeking to discover and develop
innovative medicines in areas of significant unmet medical need
with a current focus on breast cancer and COVID-19, today announced
financial results for the first quarter ended March 31, 2020, and
provided an update on recent company developments.
Key recent developments include:
- Launched a new drug development program called COVID-19 HOPE to
test AT-H201, a novel combination of two drugs that have been
previously approved by the FDA for other diseases. The goal of the
COVID-19 HOPE program is to develop a therapy to improve lung
function and reduce the amount of time that COVID-19 patients are
on ventilators. Atossa has applied to the FDA for approval to
commence a clinical study in this setting.
- Announced that Atossa has contracted with NYC Health +
Hospitals/Metropolitan in New York City to conduct the COVID-19
HOPE study of AT-H201.
- Announced positive interim results from Atossa’s Phase 2 study
of oral Endoxifen to treat breast cancer in the “window of
opportunity” between diagnosis of breast cancer and surgery. A
statistically significant (p = 0.031) reduction of about 74% in
tumor cell proliferation was achieved over an average of 22 days of
dosing. Proliferation was measured by Ki-67, a recognized standard
measurement of breast cancer cell proliferation. Other recent
progress with this program includes contracting with Avance
Clinical to open a second site for the study in Geelong, Victoria,
Australia, with the goal of increasing the rate of enrollment;
applying to the Institutional Review Board for approval to open the
second site; and, manufacturing sufficient Endoxifen necessary for
all patients expected to enroll in this study.
- Announced that recent input from the FDA on Atossa’s oral
Endoxifen program will inform Atossa’s clinical trial strategy and
study design both in the U.S. and in Stockholm, Sweden, where
Atossa is planning a Phase 2 study to reduce MBD. Atossa plans to
commence the MBD study in Stockholm after receiving approval by the
European Medical Product Authority (MPA) and the re-opening of
mammography clinics in Stockholm following the COVID-19
closures.
“The beginning of 2020 has been eventful both in terms of our
accomplishments in moving our Endoxifen clinical programs forward,
as well as the launch of our COVID-19 HOPE program,” said Dr.
Steven Quay, Atossa’s President and Chief Executive Officer. “We
achieved tremendous success with the initial group of patients in
our oral Endoxifen window of opportunity Phase 2 study. We look
forward to continuing enrollment in our window of opportunity study
and to commencing our Endoxifen Phase 2 study in Stockholm, Sweden
when the COVID-19 restrictions are eased.”
March 31, 2020 Financial Results
For the quarter ended March 31, 2020, Atossa had no source of
sustainable revenue and no associated cost of revenue.
Operating Expenses: Total operating expenses were approximately
$2,937,000 for the three months ended March 31, 2020, which is
a decrease of approximately $1,127,000 or 28%, from the
three months ended March 31, 2019. Operating expenses consisted of
research and development (“R&D”) expenses of approximately
$939,000 and general and administrative ("G&A") expenses of
approximately $1,998,000. Operating expenses for
2019 consisted of R&D expenses of
approximately $1,451,000, and G&A expenses of
approximately $2,613,000. The basis for decreased operating
expenses in 2020 is explained below.Research and Development
Expenses: R&D expenses for the three months ended March 31,
2020, were approximately $939,000, a decrease of approximately
$512,000 or 35% from total R&D expenses for the three months
ended March 31, 2019 of approximately $1,451,000. R&D
expense consists primarily of clinical trial expenses
associated with our Endoxifen program, salaries and non-cash
stock-based compensation expense. The decrease in R&D expense
is attributed to the decrease in non-cash stock-based compensation
expense of approximately $514,000. We expect our R&D
expenses to increase throughout 2020 as we commence studies of
AT-H201 including the COVID-19 HOPE study, additional Phase 2
clinical trials of Endoxifen, continue the clinical trial
of Fulvestrant administered via our intraductal technology and
continue the development of other indications and therapeutics,
including CAR-T and immunotherapies administered via our
intraductal technologies.
General and Administrative Expenses: G&A expenses were
approximately $1,998,000 for the three months ended March 31, 2020,
a decrease of approximately $615,000, or 24% from total
G&A expenses for the three months ended March 31, 2019, of
approximately $2,613,000. G&A expenses consist primarily of
salaries and related benefit costs, non-cash stock-based
compensation, facilities, professional services, insurance, and
public company related expenses. The decrease in G&A expenses
for the quarter ended March 31, 2020, is mainly
attributed to the decrease in non-cash stock-based
compensation expense of approximately $816,000, offset by an
increase in salaries, legal and professional fees of approximately
$200,000, as compared to the same period in 2019.
As of March 31, 2020, the Company had approximately $9.4 million
in cash and cash equivalents.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical
company seeking to discover and develop innovative medicines in
areas of significant unmet medical need 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 such as the COVID-19
HOPE study, 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, |
|
|
|
|
|
|
|
2020 |
|
|
As of December 31, |
|
Assets |
|
(Unaudited) |
|
|
2019 |
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,351,141 |
|
|
$ |
12,581,136 |
|
Restricted cash |
|
|
110,000 |
|
|
|
110,000 |
|
Prepaid expenses |
|
|
1,337,120 |
|
|
|
862,344 |
|
Research and development tax rebate receivable |
|
|
734,340 |
|
|
|
739,656 |
|
Other current assets |
|
|
134,519 |
|
|
|
26,130 |
|
Total current assets |
|
|
11,667,120 |
|
|
|
14,319,266 |
|
|
|
|
|
|
|
|
|
|
Furniture and equipment, net |
|
|
29,734 |
|
|
|
34,350 |
|
Intangible assets, net |
|
|
60,833 |
|
|
|
68,542 |
|
Right-of-use asset |
|
|
37,397 |
|
|
|
50,479 |
|
Other assets |
|
|
17,218 |
|
|
|
17,218 |
|
Total Assets |
|
$ |
11,812,302 |
|
|
$ |
14,489,855 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
356,252 |
|
|
$ |
293,171 |
|
Accrued expenses |
|
|
52,474 |
|
|
|
77,888 |
|
Payroll liabilities |
|
|
466,383 |
|
|
|
899,420 |
|
Lease liability |
|
|
29,385 |
|
|
|
39,371 |
|
Other current liabilities |
|
|
3,458 |
|
|
|
12,892 |
|
Total current liabilities |
|
|
907,952 |
|
|
|
1,322,742 |
|
Long term liabilities |
|
|
|
|
|
|
|
|
Lease liability long term |
|
|
8,013 |
|
|
|
11,108 |
|
Total Liabilities |
|
|
915,965 |
|
|
|
1,333,850 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Preferred stock - $0.001 par value; 10,000,000 shares authorized;
671 shares issued and outstanding as of March 31, 2020 and December
31, 2019, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital - Series B convertible preferred
stock |
|
|
670,999 |
|
|
|
670,999 |
|
Common stock - $0.18 par value; 175,000,000 shares authorized, and
9,130,984 shares issued and outstanding, as of March 31, 2020 and
December 31, 2019, respectively |
|
|
1,643,565 |
|
|
|
1,643,565 |
|
Additional paid-in capital |
|
|
105,600,232 |
|
|
|
104,912,480 |
|
Accumulated deficit |
|
|
(97,018,460 |
) |
|
|
(94,071,040 |
) |
Total Stockholders' Equity |
|
|
10,896,337 |
|
|
|
13,156,005 |
|
Total Liabilities and Stockholders' Equity |
|
$ |
11,812,302 |
|
|
$ |
14,489,855 |
|
|
|
|
|
|
|
|
|
|
ATOSSA THERAPEUTICS, INC. CONDENSED
CONSOLIDATED STATEMENTS OF
OPERATIONS(UNAUDITED) |
|
|
For the Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
|
|
|
2020 |
|
|
2019 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
938,620 |
|
|
$ |
1,451,236 |
|
General and
administrative |
|
|
1,998,389 |
|
|
|
2,613,093 |
|
Total operating expenses |
|
|
2,937,009 |
|
|
|
4,064,329 |
|
Operating loss |
|
|
(2,937,009 |
) |
|
|
(4,064,329 |
) |
Other expense |
|
|
(10,411 |
) |
|
|
(8,978 |
) |
Loss before income taxes |
|
|
(2,947,420 |
) |
|
|
(4,073,307 |
) |
Income taxes |
|
|
- |
|
|
|
- |
|
Net loss |
|
$ |
(2,947,420 |
) |
|
$ |
(4,073,307 |
) |
Loss per common share - basic
and diluted |
|
$ |
(0.32 |
) |
|
$ |
(0.62 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
9,130,984 |
|
|
|
6,565,514 |
|
|
|
|
|
|
|
|
|
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