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 year end 2018 financial results and
provided an update on recent company developments.
Steven C. Quay, M.D., Ph.D., Atossa Genetics’ President and CEO
commented, "The end of 2018 marked two important milestones for
Atossa. We completed the enrollment of our Phase 2 trial for
topical Endoxifen in women with mammographic dense breasts. In
addition, we received our first allowance by the FDA to provide
Endoxifen through the federal “Expanded Access” program for a
breast cancer patient prior to her surgery. We received a second
allowance in March 2019 for this patient to continue treatment
post-surgery. In the meantime, we continue to make great progress
with our clinical programs and look forward to completing the
dosing in the topical Endoxifen MBD trial in April and announcing
preliminary results in the second quarter 2019."
Recent Corporate Developments
- Atossa's important recent developments include the
following:
- March 2019 - FDA approval of oral Endoxifen for "Expanded
Access" as post-mastectomy treatment for a U.S. breast cancer
patient
- March 2019 – Atossa received $11.3 million from the exercise of
warrants that were previously outstanding
- February 2019 - Update from "Expanded Access" program for the
U.S. breast cancer patient taking oral Endoxifen prior to surgery
showing sizeable reduction in cancer cell biological activity with
no safety or tolerability issues
- February 2019 – Atossa provided breast cancer prevention
recommendations to the United States Preventative Services Task
Force
- January 2019 – Successfully completed and provided final
results from male Phase 1 study of topical Endoxifen; no clinically
significant safety nor tolerability issues and acceptable
pharmacokinetics
- December 2018 - FDA approval of Endoxifen for "Expanded Access"
as preoperative systemic endocrine therapy for a U.S. breast cancer
patient
- October 2018 - Completed enrollment in Phase 2 study of topical
Endoxifen to treat mammographic breast density.
2018 Financial Results
For the year end December 31, 2018 and 2017, we had no revenue
and no associated cost of revenue.
Total operating expenses were $11,434,000 for the year ended
December 31, 2018, which is an increase of $3,785,000 or 49
percent, from the year ended December 31, 2017. Operating expenses
for 2018 consisted of research and development (R&D) expenses
of $4,210,000 and general and administrative (G&A) expenses of
$7,224,000. Operating expenses for 2017 consisted of R&D
expenses of $2,328,000, G&A expenses of $4,859,000 and
impairment of our Acueity intangible assets of $462,000.
R&D expenses for the year ended December 31, 2018, were
$4,210,000, an increase of $1,882,000 or 81 percent from total
R&D expenses in 2017 of $2,328,000. The increase in R&D
expense is attributed to manufacturing and clinical trials
associated with our Endoxifen program, salaries, and stock-based
compensation. Our R&D expenses have increased because we
commenced two Phase 2 studies of our proprietary Endoxifen during
the year ended December 31, 2018. There were no Phase 2 studies of
Endoxifen in 2017. Stock-based compensation expense also increased
approximately $627,000 in 2018 as compared to 2017. We expect our
R&D expenses to increase throughout 2019 as we commence
additional Phase 2 clinical studies of Endoxifen, continue the
clinical trial of fulvestrant administered via our microcatheters
and continue the development of other indications and therapeutics,
including CAR-T and immunotherapies administered via our
intraductal technology.
G&A expenses were $7,224,000 for the year ended December 31,
2018, an increase of $2,365,000, or 49 percent from the total
G&A expenses for the year ended December 31, 2017, of
$4,859,000. 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 year ended December 31, 2018, is
mainly attributed to an increase in stock-based compensation
expense of approximately $1,049,000, payroll expenses resulting
from salary increases, one-time bonus payments of $350,000 and
increased legal and professional consulting expenses of
approximately $600,000 over the prior year.
As of December 31, 2018, the company had cash, cash equivalents
and restricted cash of $10.5 million and in March 2019 received
$11.3 million in additional cash from the exercise of previously
outstanding warrants.
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.
CONSOLIDATED BALANCE SHEETS
|
As of December 31, |
|
Assets |
2018 |
|
|
2017 |
|
Current assets |
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
10,380,493 |
|
|
$ |
7,217,469 |
|
Restricted cash |
|
110,000 |
|
|
|
55,000 |
|
Prepaid
expenses |
|
509,833 |
|
|
|
250,944 |
|
Research
and development tax rebate receivable |
|
518,098 |
|
|
|
358,277 |
|
Other
current assets |
|
30,942 |
|
|
|
16,344 |
|
Total
current assets |
|
11,549,366 |
|
|
|
7,898,034 |
|
|
|
|
|
|
|
|
|
Furniture
and equipment, net |
|
54,487 |
|
|
|
11,467 |
|
Intangible assets, net |
|
99,375 |
|
|
|
75,686 |
|
Other
assets |
|
17,218 |
|
|
|
178,907 |
|
Total
Assets |
$ |
11,720,446 |
|
|
$ |
8,164,094 |
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
Accounts
payable |
$ |
353,328 |
|
|
$ |
334,901 |
|
Accrued
expenses |
|
177,074 |
|
|
|
90,105 |
|
Payroll
liabilities |
|
935,070 |
|
|
|
784,867 |
|
Stock-based compensation liability |
|
1,410,025 |
|
|
|
|
|
Other
current liabilities |
|
39,939 |
|
|
|
15,534 |
|
Total
Current Liabilities |
|
2,915,436 |
|
|
|
1,225,407 |
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders'
equity |
|
|
|
|
|
|
|
Preferred
stock - $0.001 par value; 10,000,000 shares authorized, consisting
of Series A convertible preferred stock- $0.001 par value; 4,000
shares authorized, and 0 shares outstanding as of December 31, 2018
and December 31, 2017; Series B convertible preferred stock- $0.001
par value; 25,000 and 0 shares authorized, and 2,379 and 0 shares
issued and outstanding as of December 31, 2018 and December 31,
2017, respectively |
|
2 |
|
|
|
|
|
Additional paid-in capital - Series B convertible preferred
stock |
|
2,378,997 |
|
|
|
|
|
Common
stock - $0.18 par value; 175,000,000 shares authorized, and
5,846,552 and 2,651,952 shares issued and outstanding, as of
December 31, 2018 and December 31, 2017, respectively |
|
1,052,372 |
|
|
|
477,342 |
|
Additional paid-in capital |
|
82,204,902 |
|
|
|
71,887,674 |
|
Accumulated deficit |
|
(76,831,263 |
) |
|
|
(65,426,329 |
) |
Total
Stockholders' Equity |
|
8,805,010 |
|
|
|
6,938,687 |
|
|
|
|
|
|
|
|
|
Total
Liabilities and Stockholders' Equity |
$ |
11,720,446 |
|
|
$ |
8,164,094 |
|
|
|
|
|
|
|
|
|
ATOSSA GENETICS INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS
|
For the Years Ended December 31, |
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
Research and
development |
$ |
4,209,981 |
|
|
$ |
2,328,087 |
|
General and
administrative |
|
7,224,252 |
|
|
|
4,859,369 |
|
Impairment of
intangible assets |
|
|
|
|
|
461,715 |
|
Total operating
expenses |
|
11,434,233 |
|
|
|
7,649,171 |
|
Operating loss |
|
(11,434,233 |
) |
|
|
(7,649,171 |
) |
Change in fair value of
common stock warrants |
|
|
|
|
|
(280,747 |
) |
Warrant financing
expense |
|
|
|
|
|
(192,817 |
) |
Other income |
|
29,299 |
|
|
|
154 |
|
Loss before income
taxes |
|
(11,404,934 |
) |
|
|
(8,122,581 |
) |
Income taxes |
|
|
|
|
|
|
|
Net loss |
$ |
(11,404,934 |
) |
|
$ |
(8,122,581 |
) |
Deemed dividend
attributable to preferred stock |
|
(11,479,308 |
) |
|
|
(2,568,132 |
) |
Net loss applicable to
common shareholders |
$ |
(22,884,242 |
) |
|
$ |
(10,690,713 |
) |
Loss per common share -
basic and diluted |
$ |
(5.50 |
) |
|
$ |
(10.97 |
) |
Weighted average shares
outstanding - basic and diluted |
|
4,157,746 |
|
|
|
974,773 |
|
|
|
|
|
|
|
|
|
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