Atossa Genetics Announces Third Quarter 2018 Financial Results And Provides Company Update
November 13 2018 - 4:10PM
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 third quarter ended September 30, 2018
financial results and provided an update on recent company
developments.
Steven C. Quay, Ph.D., MD, President and CEO
commented, “We continue to make great progress with our clinical
programs. We successfully achieved all objectives in our Phase 1
study of topical Endoxifen in men and are looking forward to
advancing that program into a Phase 2 study to address gynecomastia
in men being treated for prostate cancer. We also completed
enrollment in the Phase 2 study of our topical Endoxifen to treat
mammographic breast density,” added Dr. Quay.Recent
Corporate DevelopmentsAtossa’s important recent
developments include the following:
- October 2018 – Completed enrollment in Phase 2 study of topical
Endoxifen to treat mammographic breast density.
- September 2018 – Reported that all objectives were achieved in
our Phase 1 study of topical Endoxifen in men.
- August 2018 - Contracted with a US-based additional
manufacturer of Endoxifen.
- July 2018 - Announced intraductal microcatheter immunoOncology
pre-clinical program.
- June 2018 – Appointed two additional prominent industry
executives from Pfizer and the Belgium-based Flemish Institute of
Biotechnology to strategic advisory board.
Q3 2018 Financial Results
For the three and nine months ended September 30, 2018 and 2017,
we had no revenue and no associated cost of revenue.
Total operating expenses were approximately $3.3 million and
$9.3 million for the three and nine months ended September 30,
2018, respectively, consisting of research and development
(R&D) expenses of approximately $1.4 million and $3.4 million,
respectively, and general and administrative (G&A) expenses of
approximately $1.9 million and $6.0 million, respectively. Total
operating expenses were approximately $2.1 million and $5.7 million
for the three and nine months ended September 30, 2017,
respectively, consisting of R&D expenses of $0.7 million and
$2.1 million, respectively, and G&A expense of approximately
$1.3 million and $3.5 million, respectively.
Total operating expenses for the three and nine months ended
September 30, 2018 as compared to the same periods of 2017
increased approximately $1.3 million, or 61%, and increased $3.7
million, or 65%, respectively.
As of September 30, 2018, the Company had cash and cash
equivalents and restricted cash of $13.0 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 Form 10-K and 10-Q, each
as amended and supplemented from time to time.
Atossa Genetics Company Contact:
Atossa Genetics Inc.Kyle GuseCFO and General CounselOffice: 866
893-4927kyle.guse@atossagenetics.com
Investor Relations Contact:
Scott GordonCorProminence LLC377 Oak StreetConcourse 2Garden
City, NY 11530Office: (516) 222-2560scottg@corprominence.com
Source: Atossa Genetics Inc.ATOSSA GENETICS
INC.CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
|
|
September 30, |
|
|
December 31, |
|
Assets |
|
2018 |
|
|
2017 |
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
12,935,587 |
|
|
$ |
7,217,469 |
|
Restricted cash |
|
|
55,000 |
|
|
|
55,000 |
|
Prepaid expenses |
|
|
290,331 |
|
|
|
250,944 |
|
Research and
development tax rebate receivable |
|
|
480,495 |
|
|
|
358,277 |
|
Other current
assets |
|
|
161,530 |
|
|
|
16,344 |
|
Total current
assets |
|
|
13,922,943 |
|
|
|
7,898,034 |
|
|
|
|
|
|
|
|
|
|
Furniture and
equipment, net |
|
|
57,804 |
|
|
|
11,467 |
|
Intangible assets,
net |
|
|
55,107 |
|
|
|
75,686 |
|
Other assets |
|
|
88,518 |
|
|
|
178,907 |
|
Total
Assets |
|
$ |
14,124,372 |
|
|
$ |
8,164,094 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
550,704 |
|
|
$ |
334,901 |
|
Accrued expenses |
|
|
51,673 |
|
|
|
90,105 |
|
Payroll
liabilities |
|
|
706,150 |
|
|
|
784,867 |
|
Stock-based
compensation liability |
|
|
2,180,659 |
|
|
|
|
|
Other current
liabilities |
|
|
66,077 |
|
|
|
15,534 |
|
Total Current
Liabilities |
|
|
3,555,263 |
|
|
|
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 September 30, 2018 and
December 31, 2017; Series B convertible preferred stock- $0.001 par
value;25,000 and 0 shares authorized, and 3,517 and 0 shares issued
and outstanding as of September 30, 2018 and December 31, 2017,
respectively |
|
|
4 |
|
|
|
|
|
Additional paid-in
capital- Series B convertible preferred stock |
|
|
3,516,996 |
|
|
|
|
|
Common stock - $0.18
par value; 175,000,000 shares authorized, and 5,523,255 and
2,651,952 shares issued and outstanding,as of September 30, 2018
and December 31, 2017, respectively |
|
|
994,175 |
|
|
|
477,342 |
|
Additional paid-in
capital |
|
|
80,811,088 |
|
|
|
71,887,674 |
|
Accumulated
deficit |
|
|
(74,753,154 |
) |
|
|
(65,426,329 |
) |
Total Stockholders'
Equity |
|
|
10,569,109 |
|
|
|
6,938,687 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities and
Stockholders' Equity |
|
$ |
14,124,372 |
|
|
$ |
8,164,094 |
|
|
|
|
|
|
|
|
|
|
ATOSSA GENETICS INC. CONDENSED
CONSOLIDATED STATEMENTS OF
OPERATIONS(UNAUDITED)
|
|
For the Three MonthsEnded September
30, |
|
|
For the Nine MonthsEnded September
30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
1,421,851 |
|
|
$ |
742,450 |
|
|
$ |
3,360,563 |
|
|
$ |
2,110,846 |
|
General and
administrative |
|
|
1,888,119 |
|
|
|
1,313,477 |
|
|
|
5,966,504 |
|
|
|
3,544,935 |
|
Total operating
expenses |
|
|
3,309,970 |
|
|
|
2,055,927 |
|
|
|
9,327,067 |
|
|
|
5,655,781 |
|
Operating loss |
|
|
(3,309,970 |
) |
|
|
(2,055,927 |
) |
|
|
(9,327,067 |
) |
|
|
(5,655,781 |
) |
Change in fair value of
common stock warrants |
|
|
|
|
|
|
(128,300 |
) |
|
|
|
|
|
|
(280,747 |
) |
Warrant financing
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(192,817 |
) |
Other income
(expense) |
|
|
104 |
|
|
|
(283 |
) |
|
|
242 |
|
|
|
(208 |
) |
Loss before income
taxes |
|
|
(3,309,866 |
) |
|
|
(2,184,510 |
) |
|
|
(9,326,825 |
) |
|
|
(6,129,553 |
) |
Income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(3,309,866 |
) |
|
$ |
(2,184,510 |
) |
|
$ |
(9,326,825 |
) |
|
$ |
(6,129,553 |
) |
Deemed Dividend
attributable to preferred stock |
|
|
|
|
|
|
|
|
|
|
(11,479,308 |
) |
|
|
(2,568,132 |
) |
Net loss applicable to
common shareholders |
|
$ |
(3,309,866 |
) |
|
$ |
(2,184,510 |
) |
|
$ |
(20,806,133 |
) |
|
$ |
(8,697,685 |
) |
Loss per common share -
basic and diluted |
|
$ |
(0.64 |
) |
|
$ |
(2.11 |
) |
|
$ |
(5.71 |
) |
|
$ |
(13.23 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
5,183,492 |
|
|
|
1,034,262 |
|
|
|
3,645,682 |
|
|
|
657,184 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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