Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company seeking to discover and develop
innovative medicines in oncology and infectious disease with a
current focus on breast cancer and COVID-19, today announces
financial results for the fiscal quarter ended June 30, 2021, and
provides an update on recent company developments.
Key developments from Q2 2021 and to date include:
- Atossa received final data from its open-label Phase 2 clinical
study of oral Endoxifen administered in the “window of
opportunity” between diagnosis of breast cancer and surgery,
which showed that the primary endpoint of the study was achieved:
Ki-67, a common measure of tumor cell activity, was reduced from an
average of 25.6% at screening to 6% on the day of surgery, a 65.1%
reduction. Ki-67 was reduced below 25% for all patients, which is
potentially clinically meaningful because studies by others have
shown that a reduction below 25% improves long term survival.
- Received authorization from Swedish regulators to initiate a
Phase 2 clinical study of Endoxifen to reduce mammographic breast
density (MBD).
- Received authorization from Australian regulators to initiate a
clinical study of AT-H201 which is being developed for the
treatment of patients with COVID-19 and “long
haul” respiratory illness.
- Announced final results from its Phase 1 double-blinded,
randomized, placebo-controlled clinical study using Atossa’s
proprietary drug candidate AT-301 administered by nasal spray.
AT-301 was considered safe and well tolerated in healthy male and
female participants in this study at two different dose levels over
14 days. AT-301 is being developed for at home use for patients
recently diagnosed with COVID-19.
- Completed treatment of oral Endoxifen in an ovarian cancer
patient under the FDA’s Expanded Access Pathway. The patient has
recurring, metastatic, late-stage ovarian cancer and had not
improved on other therapies. Although organoid testing
conducted by a third party had previously shown a strong response
to Endoxifen in combination with Apelisib, she
has unfortunately continued to experience disease progression
and is not expected to continue treatment with Endoxifen.
- Through the completion of capital raising transactions and the
exercise of warrants, Atossa has grown its cash balances quarter
over quarter for the past three quarters, ending the second quarter
2021 with $142.4 million in cash and cash equivalents.
- Scheduled a special stockholder meeting for September 7, 2021
for the purpose of approving an increase in authorized shares of
common stock. If the proposal is approved by the stockholders,
Atossa does not intend to issue any of the newly authorized shares
of common stock for the purpose of raising capital in the nine
months following approval of the proposal at a price less than $10
per share. The newly authorized shares of common stock are intended
to be used at any time to complete and/or support acquisitions,
collaborations, partnerships and licensing transactions.
“We continue to experience encouraging progress in our MBD and
COVID-19 programs, with new regulatory approvals being granted in
Sweden for a Phase 2 trial in MBD and authorization in Australia to
commence a Phase 2 study of AT-H201 for respiratory illness
associated with COVID-19,” said Dr. Steven Quay, Atossa’s President
and Chief Executive Officer.
“In the meantime, we continue to enjoy a strong balance sheet,
which we have significantly expanded over the last three quarters
and will facilitate our development plans over the near term. As we
actively explore the possibility for strategic expansion into other
areas where we might see near-term milestones and results, we also
urge all of our shareholders to exercise their right to vote at our
special stockholder’s meeting on September 7, 2021. We urge a vote
in favor of the proposal to increase authorized shares, which will
provide the Company with the flexibility to issue shares as part of
these potential acquisitions, collaborations and partnerships, a
common strategy successful biotech companies seeking to grow
shareholder value employ in order to create a more attractive
opportunity for all. We look forward to continuing to update our
stockholders on these opportunities as they develop,” concluded Dr.
Quay.
Quarter Ended June 30, 2021, Financial
Results
For the quarter ended June 30, 2021, Atossa has no source of
sustainable revenue and no associated cost of revenue.
As of June 30, 2021, the Company had cash, cash equivalents and
restricted cash of approximately $142.5 million.
Operating ExpensesTotal operating expenses were approximately
$7,004,000 and $10,534,000 for the three and
six months ended June 30, 2021, respectively,
consisting of research and development ("R&D") expenses of
approximately $3,799,000 and $5,177,000 respectively, and general
and administrative ("G&A") expenses of approximately $3,205,000
and $5,357,000, respectively. Total operating expenses were
approximately $3,936,000 and $6,873,000, respectively for the three
and six month ended June 30, 2020, and consisted of R&D
expenses of approximately $1,653,000 and $2,592,000,
respectively, and G&A expenses of approximately $2,283,000
and $4,281,000 respectively. Total operating expenses for the three
and six months ended June 30, 2021, as compared to the same period
in 2020 increased approximately $3,068,000 and
$3,661,000 or 78% and 53%, respectively.
Research and Development ExpensesR&D expenses for the three
months ended June 30, 2021, were approximately $3,799,000, an
increase of approximately $2,146,000 or 130% from total R&D
expenses for the three months ended June 30, 2020, of
approximately $1,653,000. R&D expenses for the
six months ended June 30, 2021, were approximately $5,177,000,
an increase of approximately $2,585,000 or 100% from total R&D
expenses for the six months ended June 30, 2020, of
approximately $2,592,000. The increase in R&D expense is
attributed primarily to an increase in clinical trial expense of
approximately $1,309,000 and an increase in compensation of
approximately $211,000 due to the addition of two employees,
as compared to the same period in 2020. Also included in R&D
expenses is an increase of $1,000,000 attributable to a
one-time fee we paid in June 2021 to a U.S. leading research
institution for the exclusive right to negotiate for the
acquisition of the world-wide rights to two oncology R&D
programs. We expect our R&D expenses to continue to
increase into 2021 as we seek to commence a clinical study of
AT-H201, complete studies of AT-301, launch a Phase
2 clinical trial of Endoxifen in women with high breast
density, and continue the development of other indications and
therapeutics.
General and Administrative ExpensesG&A expenses were
$3,205,000 for the three months ended June 30, 2021, an
increase of approximately $922,000, or 40% from the total G&A
expenses for the three months ended June 30, 2020, of
approximately $2,283,000. G&A expenses for the
six months ended June 30, 2021, were approximately $5,357,000,
an increase of approximately $1,076,000 or 25% from total R&D
expenses for the six months ended June 30, 2020, of
approximately $4,281,000. The increase in G&A expenses for
the three and six months ended June 30, 2021, is
attributed to an increase in insurance costs of approximately
$387,000 due to the addition of the COVID-19 clinical
trials, professional fees of approximately $703,000 due
primarily to increased proxy costs and increased compensation
of approximately $170,000, offset by a reduction in legal fees
of approximately $301,000 compared to the same period in 2020.
G&A expenses consist primarily of personnel and related benefit
costs, facilities, professional services, insurance, and public
company related expenses.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical
company seeking to discover and develop innovative medicines in
oncology and infectious diseases 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 of AT-H201, AT-301 and
Endoxifen, 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 CounselOffice: (866) 893-4927kyle.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 June 30, 2021 |
|
|
As of December 31, |
|
Assets |
(Unaudited) |
|
|
2020 |
|
Current assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
142,432,961 |
|
|
$ |
39,553,671 |
|
Restricted cash |
|
110,000 |
|
|
|
110,000 |
|
Prepaid expenses |
|
2,391,966 |
|
|
|
1,813,902 |
|
Research and development tax rebate receivable |
|
817,109 |
|
|
|
634,940 |
|
Other current assets |
|
78,882 |
|
|
|
657,662 |
|
Total current assets |
|
145,830,918 |
|
|
|
42,770,175 |
|
|
|
|
|
|
|
|
|
Furniture and equipment, net |
|
14,501 |
|
|
|
20,632 |
|
Intangible assets, net |
|
4,458 |
|
|
|
13,375 |
|
Right-of-use asset |
|
4,720 |
|
|
|
18,053 |
|
Other assets |
|
13,408 |
|
|
|
17,218 |
|
Total Assets |
$ |
145,868,005 |
|
|
$ |
42,839,453 |
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
Accounts payable |
$ |
537,915 |
|
|
$ |
1,588,613 |
|
Accrued expenses |
|
531,602 |
|
|
|
93,367 |
|
Payroll liabilities |
|
700,588 |
|
|
|
963,665 |
|
Common stock warrant
liability |
|
- |
|
|
|
13,003,075 |
|
Lease liability |
|
4,720 |
|
|
|
18,053 |
|
Other current liabilities |
|
21,278 |
|
|
|
4,748 |
|
Total current liabilities |
|
1,796,103 |
|
|
|
15,671,521 |
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
Preferred stock - $0.001 par value; 10,000,000 shares authorized;
587 and 621 shares issued and outstanding as of June 30, 2021 and
December 31, 2020, respectively |
|
1 |
|
|
|
1 |
|
Additional paid-in capital - Series B convertible preferred
stock |
|
586,999 |
|
|
|
620,999 |
|
Common stock - $0.18 par value; 175,000,000 shares authorized;
125,925,096 and 47,548,835 shares issued and outstanding as of June
30, 2021 and December 31, 2020, respectively |
|
22,666,505 |
|
|
|
8,558,778 |
|
Additional paid-in capital |
|
240,023,345 |
|
|
|
129,887,146 |
|
Accumulated deficit |
|
(119,204,948 |
) |
|
|
(111,898,992 |
) |
Total Stockholders' Equity |
|
144,071,902 |
|
|
|
27,167,932 |
|
Total Liabilities and Stockholders' Equity |
$ |
145,868,005 |
|
|
$ |
42,839,453 |
|
ATOSSA THERAPEUTICS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(UNAUDITED)
|
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June 30, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
3,798,636 |
|
|
$ |
1,653,239 |
|
|
$ |
5,177,123 |
|
|
$ |
2,591,859 |
|
General and
administrative |
|
3,205,130 |
|
|
|
2,282,568 |
|
|
|
5,357,371 |
|
|
|
4,280,957 |
|
Total operating expenses |
|
7,003,766 |
|
|
|
3,935,807 |
|
|
|
10,534,494 |
|
|
|
6,872,816 |
|
Operating loss |
|
(7,003,766 |
) |
|
|
(3,935,807 |
) |
|
|
(10,534,494 |
) |
|
|
(6,872,816 |
) |
Other income (expense),
net |
|
(35,482 |
) |
|
|
29,665 |
|
|
|
(42,823 |
) |
|
|
19,254 |
|
Loss before income taxes |
|
(7,039,248 |
) |
|
|
(3,906,142 |
) |
|
|
(10,577,317 |
) |
|
|
(6,853,562 |
) |
Income taxes |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss |
$ |
(7,039,248 |
) |
|
$ |
(3,906,142 |
) |
|
$ |
(10,577,317 |
) |
|
$ |
(6,853,562 |
) |
Loss per common share - basic
and diluted |
$ |
(0.06 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.75 |
) |
Weighted average shares
outstanding - basic and diluted |
|
121,572,091 |
|
|
|
9,187,588 |
|
|
|
107,159,698 |
|
|
|
9,159,286 |
|
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