Atossa Genetics Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company developing novel therapeutics and
delivery methods to treat breast cancer and other breast
conditions, today announced financial results for the second
quarter ended June 30, 2019 and provided an update on recent
company developments.
Steven C. Quay, M.D., Ph.D., Atossa Genetics’ President and CEO
commented, "During the quarter we were very pleased to have
achieved our primary endpoint in our Phase 2 trial of topical
Endoxifen to reduce mammographic breast density (MBD). We are now
focusing our efforts on the oral formulation of Endoxifen and are
developing a modified-release oral tablet which is being tested in
a Phase 1 study and that we plan to use in a Phase 2 study to
reduce MBD. The Phase 2 study is scheduled to start in the fourth
quarter and should be completed by mid-2020. We completed the
quarter with $17.1 million in cash, which will enable us to
continue to make clinical progress with our programs."
Recent Developments
Recent developments include the following:
- July 2019 – Provided update on expanded access program, which
now allows physicians and patients to visit the company website to
obtain information on compassionate use access
- July 2019 – Initiated a Phase 1 study of our proprietary
modified-release oral Endoxifen tablet
- June 2019 – Successfully reached the primary endpoint of MBD
reduction using the topical formulation of Endoxifen in a Phase 2
study
Q2 2019 Financial Results
For the three and six months ended June 30, 2019 and 2018, we
have no source of sustainable revenue and no associated cost of
revenue.
Total operating expenses were approximately $7,286,000 and
$11,350,000 for the three and six months ended June 30, 2019,
respectively, consisting of research and development (R&D)
expenses of approximately $2,612,000 and $4,063,000 respectively,
and general and administrative (G&A) expense of approximately
$4,674,000 and $7,287,000, respectively. Total operating expenses
were approximately $4,143,000 and $6,017,000 for the three and six
months ended June 30, 2018, respectively, consisting of research
and development expenses of approximately $1,468,000 and
$1,939,000, respectively, and general and administrative expenses
of approximately $2,675,000 and $4,078,000, respectively.
R&D expenses for the three months ended June 30, 2019, were
approximately $2,612,000, an increase of approximately $1,144,000
or 78% from total R&D expenses for the three months ended June
30, 2018 of approximately $1,468,000. R&D expenses for the six
months ended June 30, 2019, were approximately $4,063,000, an
increase of approximately $2,124,000 or 110% from total R&D
expenses for the six months ended June 30, 2018 of approximately
$1,939,000. The increase in R&D expenses for the period
ended June 30, 2019, is mainly attributed to an increase in
stock-based compensation expense (non-cash). We expect our R&D
expenses to increase throughout 2019 as we commence an additional
Phase 2 clinical study of oral Endoxifen, develop and manufacture
our modified release tablet form of oral Endoxifen, continue our
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.
G&A expenses were approximately $4,674,000 for the three
months ended June 30, 2019, an increase of approximately
$1,999,000, or 75% from the total G&A expenses for the three
months ended June 30, 2018, of approximately $2,675,000.
G&A expenses were approximately $7,287,000 for the
six months ended June 30, 2019, an increase of approximately
$3,209,000, or 79% from the total G&A expenses for the
six months ended June 30, 2018, of approximately
$4,078,000. G&A expenses consist primarily of personnel and
related benefit costs, facilities, professional services,
insurance, and public company related expenses. The increase in
G&A expenses for the period ended June 30,
2019, is mainly attributed to an increase in stock-based
compensation expense (non-cash). Additionally, payroll
expenses have increased resulting from salary increases over the
prior year.
As of June 30, 2019, Atossa had approximately $17.1 million in
cash and cash equivalents and working capital of approximately
$17.4 million.
About Atossa Genetics
Atossa Genetics Inc. is a clinical-stage biopharmaceutical
company developing novel therapeutics and delivery methods to treat
breast cancer and other breast conditions. For more information,
please visit www.atossagenetics.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
preliminary 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, lower than
anticipated rate of patient enrollment, estimated market size of
drugs under development, the safety and efficacy of Atossa's
products and services, performance of clinical research
organizations and investigators, obstacles resulting from
proprietary rights held by others with respect to fulvestrant, such
as patent rights, potential market sizes for Atossa's drugs under
development 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 Form10-K and 10-Q, each
as amended and supplemented from time to time.
Atossa Genetics Company Contact: Atossa Genetics Inc. Kyle Guse
CFO and General Counsel Office: 866 893-4927
kyle.guse@atossagenetics.com
Investor Relations Contact: Scott Gordon Core IR377 Oak
StreetConcourse 2Garden City, NY 11530Office:(516)
222-2560scottg@corprominence.com
Source: Atossa Genetics Inc.
ATOSSA GENETICS INC.CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
As of June 30, |
|
|
|
As of |
|
|
|
2019 |
|
|
December 31, |
|
Assets |
|
(Unaudited) |
|
|
2018 |
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
17,058,527 |
|
|
$ |
10,380,493 |
|
Restricted cash |
|
|
110,000 |
|
|
|
110,000 |
|
Prepaid expenses |
|
|
813,168 |
|
|
|
509,833 |
|
Research and development tax
rebate receivable |
|
|
406,306 |
|
|
|
518,098 |
|
Other current assets |
|
|
140 |
|
|
|
30,942 |
|
Total current assets |
|
|
18,388,141 |
|
|
|
11,549,366 |
|
|
|
|
|
|
|
|
|
|
Furniture and equipment,
net |
|
|
44,174 |
|
|
|
54,487 |
|
Intangible assets, net |
|
|
83,958 |
|
|
|
99,375 |
|
Right-of-use asset |
|
|
75,822 |
|
|
|
- |
|
Other assets |
|
|
17,218 |
|
|
|
17,218 |
|
Total Assets |
|
$ |
18,609,313 |
|
|
$ |
11,720,446 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
318,266 |
|
|
$ |
353,328 |
|
Accrued expenses |
|
|
53,485 |
|
|
|
177,074 |
|
Payroll liabilities |
|
|
589,445 |
|
|
|
935,070 |
|
Stock-based compensation
liability |
|
|
- |
|
|
|
1,410,025 |
|
Lease liability |
|
|
51,795 |
|
|
|
- |
|
Other current liabilities |
|
|
19,838 |
|
|
|
39,939 |
|
Total current liabilities |
|
|
1,032,829 |
|
|
|
2,915,436 |
|
Long term liabilities |
|
|
|
|
|
|
|
|
Lease liability long term |
|
|
24,027 |
|
|
|
- |
|
Total Liabilities |
|
|
1,056,856 |
|
|
|
2,915,436 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Preferred stock - $0.001 par
value; 10,000,000 shares authorized; 676 and 2,379shares issued and
outstanding as of June 30, 2019 and December 31, 2018,
respectively |
|
|
1 |
|
|
|
2 |
|
Additional paid-in capital-
Series B convertible preferred stock |
|
|
675,999 |
|
|
|
2,378,997 |
|
Common stock - $0.18 par
value; 175,000,000 shares authorized, and 9,129,563 and5,846,552
shares issued and outstanding, as of June 30, 2019 and December 31,
2018, respectively |
|
|
1,643,309 |
|
|
|
1,052,372 |
|
Additional paid-in
capital |
|
|
103,400,247 |
|
|
|
82,204,902 |
|
Accumulated deficit |
|
|
(88,167,099 |
) |
|
|
(76,831,263 |
) |
Total Stockholders'
Equity |
|
|
17,552,457 |
|
|
|
8,805,010 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities and
Stockholders' Equity |
|
$ |
18,609,313 |
|
|
$ |
11,720,446 |
|
|
|
|
|
|
|
|
|
|
ATOSSA GENETICS INC. CONDENSED
CONSOLIDATED STATEMENTS OF
OPERATIONS(UNAUDITED)
|
|
For the Three MonthsEnded June
30, |
|
|
For the Six MonthsEnded June
30, |
|
|
|
|
|
|
|
2018 |
|
|
|
|
|
2018 |
|
|
|
2019 |
|
|
(as restated) |
|
|
2019 |
|
|
(as restated) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,611,948 |
|
|
$ |
1,467,736 |
|
|
$ |
4,063,184 |
|
|
$ |
1,938,712 |
|
General and
administrative |
|
|
4,674,121 |
|
|
|
2,674,920 |
|
|
|
7,287,214 |
|
|
|
4,078,385 |
|
Total operating expenses |
|
|
7,286,069 |
|
|
|
4,142,656 |
|
|
|
11,350,398 |
|
|
|
6,017,097 |
|
Operating loss |
|
|
(7,286,069 |
) |
|
|
(4,142,656 |
) |
|
|
(11,350,398 |
) |
|
|
(6,017,097 |
) |
Other income |
|
|
23,540 |
|
|
|
79 |
|
|
|
14,562 |
|
|
|
138 |
|
Loss before income taxes |
|
|
(7,262,529 |
) |
|
|
(4,142,577 |
) |
|
|
(11,335,836 |
) |
|
|
(6,016,959 |
) |
Income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss |
|
$ |
(7,262,529 |
) |
|
$ |
(4,142,577 |
) |
|
$ |
(11,335,836 |
) |
|
$ |
(6,016,959 |
) |
Deemed dividends attributable
to preferred stock |
|
|
- |
|
|
|
(11,479,308 |
) |
|
|
- |
|
|
|
(11,479,308 |
) |
Net loss applicable to common
shareholders |
|
$ |
(7,262,529 |
) |
|
$ |
(15,621,885 |
) |
|
$ |
(11,335,836 |
) |
|
$ |
(17,496,267 |
) |
Loss per common share - basic
and diluted |
|
$ |
(0.80 |
) |
|
$ |
(5.08 |
) |
|
$ |
(1.44 |
) |
|
$ |
(6.11 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
9,126,153 |
|
|
|
3,073,803 |
|
|
|
7,852,907 |
|
|
|
2,864,033 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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