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 quarter ended
March 31, 2019 and provided an update on recent company
developments.
Steven C. Quay, M.D., Ph.D., Atossa Genetics’ President and CEO
commented, "As we anticipated, we completed dosing in the topical
Endoxifen breast density study in April and we look forward to
announcing initial top-line results later this quarter. Further, as
previously reported, the FDA approved an ‘Expanded Access’ program
for use of our oral Endoxifen to treat a breast cancer patient
prior to her surgery and in March 2019 we received a second
approval for this patient to continue treatment post-surgery. We
are planning a Phase 2 clinical study using our oral Endoxifen to
reduce breast density and we look forward to providing updates on
the launch of that study and progress with our other programs."
Q1 2019 Corporate Developments
Developments during the first quarter include the following:
- April 2019 – Completed dosing of Phase 2 topical Endoxifen
breast density trial
- April 2019 – Completed the first phase of a preclinical study
using proprietary intraductal delivery technology. The company is
now advancing to the next preclinical phase, which involves the
intraductal administration of immune modulating formulations. These
results will form the basis for advancing the intraductal delivery
program into humans and to ultimately deliver immunotherapy to
treat breast cancer using Atossa's proprietary intraductal delivery
technology
- 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 – Atossa provided breast cancer prevention
recommendations to the United States Preventative Services Task
Force
- February 2019 – Atossa reports results from expanded access
program for a U.S. breast cancer patient taking oral Endoxifen:
sizeable reduction in cancer cell biological activity; no safety or
tolerability issues
- 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
Q1 2019 Financial Results
For the quarter ended March 31, 2019 the company reported no
revenue and no associated cost of revenue.
Total operating expenses were approximately $4,064,000 for the
three months ended March 31, 2019, which is an increase of
approximately $2,190,000 or 117 percent, from the three months
ended March 31, 2018. Operating expenses for the three months ended
March 31, 2019 consisted of research and development (R&D)
expenses of approximately $1,451,000 and general and administrative
(G&A) expenses of approximately $2,613,000. Operating expenses
for the same period in 2018 consisted of R&D expenses of
approximately $471,000, and G&A expenses of approximately
$1,403,000. R&D expenses for the three
months ended March 31, 2019, were approximately $1,451,000, an
increase of approximately $980,000 or 208 percent from total
R&D expenses for the three months ended March 31, 2018 of
approximately $471,000. The increase in R&D expense is
attributed to salaries, stock-based compensation, and clinical
trial expenses associated with our Endoxifen program. Stock-based
compensation expense increased approximately $668,000 in 2019
resulting from the cancellation of stock options. There were no
option cancellations in the comparable period in 2018. 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 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 $2,613,000 for the three
months ended March 31, 2019, an increase of approximately
$1,210,000, or 86 percent from the total G&A expenses for the
three months ended March 31, 2018, of approximately $1,403,000.
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
quarter ended March 31, 2019, is mainly attributed to an
increase in stock-based compensation expense due to the
cancellation of 2018 options of approximately $1,074,000,
payroll expenses resulting from salary increases, and increased
legal and professional consulting expenses over the prior year.
As of March 31, 2019, Atossa had approximately $19.6 million in
cash and cash equivalents and working capital of approximately
$19.3 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 March 31, |
|
|
As of December 31, |
|
|
|
2019 |
|
|
2018 |
|
Assets |
|
(Unaudited) |
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
19,568,247 |
|
|
$ |
10,380,493 |
|
Restricted cash |
|
|
110,000 |
|
|
|
110,000 |
|
Prepaid expenses |
|
|
835,468 |
|
|
|
509,833 |
|
Research and development tax rebate receivable |
|
|
237,856 |
|
|
|
518,098 |
|
Other current assets |
|
|
27,957 |
|
|
|
30,942 |
|
Total current assets |
|
|
20,779,528 |
|
|
|
11,549,366 |
|
|
|
|
|
|
|
|
|
|
Furniture and equipment, net |
|
|
48,212 |
|
|
|
54,487 |
|
Intangible assets, net |
|
|
91,667 |
|
|
|
99,375 |
|
Right-of-use asset |
|
|
88,103 |
|
|
|
|
|
Other assets |
|
|
17,218 |
|
|
|
17,218 |
|
Total Assets |
|
$ |
21,024,728 |
|
|
$ |
11,720,446 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
463,970 |
|
|
$ |
353,328 |
|
Accrued expenses |
|
|
74,844 |
|
|
|
177,074 |
|
Payroll liabilities |
|
|
891,758 |
|
|
|
935,070 |
|
Stock-based compensation liability |
|
|
|
|
|
|
1,410,025 |
|
Lease liability |
|
|
50,706 |
|
|
|
|
|
Other current liabilities |
|
|
9,863 |
|
|
|
39,939 |
|
Total current liabilities |
|
|
1,491,141 |
|
|
|
2,915,436 |
|
Long term liabilities |
|
|
|
|
|
|
|
|
Lease liability long term |
|
|
37,397 |
|
|
|
|
|
Total Liabilities |
|
|
1,528,538 |
|
|
|
2,915,436 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
(note 11) |
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Preferred stock - $0.001 par value; 10,000,000 shares authorized,
consisting of Series B convertible preferred stock- $0.001 par
value; 702 and 2,379 shares issued and outstanding as of March 31,
2019 and December 31, 2018, respectively |
|
|
1 |
|
|
|
2 |
|
Additional paid-in capital- Series B convertible preferred
stock |
|
|
701,999 |
|
|
|
2,378,997 |
|
Common stock - $0.18 par value; 175,000,000 shares authorized, and
9,122,171 and 5,846,552 shares issued and outstanding, as of March
31, 2019 and December 31, 2018, respectively |
|
|
1,641,979 |
|
|
|
1,052,372 |
|
Additional paid-in capital |
|
|
98,056,781 |
|
|
|
82,204,902 |
|
Accumulated deficit |
|
|
(80,904,570 |
) |
|
|
(76,831,263 |
) |
Total Stockholders' Equity |
|
|
19,496,190 |
|
|
|
8,805,010 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities and Stockholders' Equity |
|
$ |
21,024,728 |
|
|
$ |
11,720,446 |
|
ATOSSA GENETICS
INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(UNAUDITED)
|
|
For the Three Months Ended March 31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,451,236 |
|
|
$ |
470,976 |
|
General and
administrative |
|
|
2,613,093 |
|
|
|
1,403,465 |
|
Total operating expenses |
|
|
4,064,329 |
|
|
|
1,874,441 |
|
Operating loss |
|
|
(4,064,329 |
) |
|
|
(1,874,441 |
) |
Other income (expense) |
|
|
(8,978 |
) |
|
|
59 |
|
Loss before income taxes |
|
|
(4,073,307 |
) |
|
|
(1,874,382 |
) |
Income taxes |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,073,307 |
) |
|
$ |
(1,874,382 |
) |
Loss per common share - basic
and diluted |
|
$ |
(0.62 |
) |
|
$ |
(8.48 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
6,565,514 |
|
|
|
220,996 |
|
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