Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage
biopharmaceutical company seeking to develop innovative proprietary
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, 2022, and provides an update
on recent company developments.
Key developments from Q2 2022 and to date include:
- Completed dosing in both Part B and Part C (of four parts) of
Phase 1/2a Clinical Trial of AT-H201 in healthy volunteers, which
the Company was developing as an inhalation therapy for moderately
to severely ill hospitalized COVID-19 patients and for “long-haul”
patients with post-infection pulmonary disease.
- Announced plans to shift the development of AT-H201 to more
closely align with its oncology focus by continuing the development
in patients with compromised lung function due to the damaging
effects of cancer treatment.
- Entered into an agreement with a venture-capital backed,
private company based in the United States that is in the
pre-clinical stage of developing novel Chimeric Antigen Receptor
(CAR) T-cell therapies based on technology licensed from a leading
U.S. adult and pediatric cancer treatment and research institution.
The agreement requires that up until November 1, 2022 the CAR-T
company will negotiate exclusively with Atossa for Atossa to
acquire the CAR-T company, and address certain matters related to
personnel, operations and intellectual property.
- Filed an investigational new drug application with the FDA to
initiate a Phase 2 neoadjuvant clinical study of Atossa’s
proprietary Endoxifen in premenopausal women with early-stage
estrogen receptor positive and Human Epidermal Growth Factor
Receptor 2 negative breast cancer in the United States. The FDA has
issued a clinical hold letter requesting additional information
which Atossa plans to submit by the end of the third quarter 2022
and to initiate enrollment in the fourth quarter 2022.
“We continue to make steady progress with our Endoxifen
programs: one to reduce tumor cell activity in breast cancer
patients in the neoadjuvant setting; and another to reduce dense
breast tissue in women. Our work on AT-H201 demonstrated valuable
outcomes, not the least of which was an understanding of how to
pursue its development in the field of oncology. With the
widespread availability of SARS-CoV-2 vaccines and other therapies
now approved to treat COVID-19, we believe that altering the
development pathways for AT-H201 in cancer patients with
compromised lung-function resulting from radiation treatment may
fill a compelling unmet medical need and create additional value
for our stockholders. Lung injury caused by radiation treatment
affects 30-40% of lung cancer patients, and ~35% of esophageal
cancer patients. In non-small cell cancer patients receiving
concurrent chemotherapy and radiation therapy the incidence of lung
injury is estimated to be greater than 60%. As we previously
announced, rather than proceeding with Part D of the AT-H201 study
in COVID-19 patients, we plan to quickly initiate a clinical study
of patients with compromised lung function caused by radiation
treatment and we anticipate announcing next steps in the coming
months,” commented Dr. Steven Quay, Atossa’s President and Chief
Executive Officer.
Quarter Ended June 30, 2022 Financial Results (in
thousands):
As of June 30, 2022, the Company had cash, cash equivalents and
restricted cash of approximately $125,647.
For the quarter ended June 30, 2022, Atossa had no source of
sustainable revenue and no associated cost of revenue.
Operating Expenses: Total operating expenses were
$6,595 for the three months ended June 30, 2022, which is
a decrease of $409 or 6%, from the three
months ended June 30, 2021, of $7,004. Operating expenses for
2022 consisted of research and development (R&D) expenses
of $3,433 and general and administrative (G&A) expenses of
$3,162. Operating expenses for 2021 consisted of R&D
expenses of $3,799, and G&A expenses of $3,205.
Research and Development Expenses: R&D expenses
for the three months ended June 30, 2022, were $3,433,
a decrease of $366 or 10% from total R&D expenses for
the same period in 2021 of $3,799. Clinical and
non-clinical trial costs as well as drug formulation and
analysis for our clinical trials were consistent quarter over
quarter. Total R&D compensation expense increased
primarily due to an increase in stock-based compensation of
$270 and increased salaries, bonus and benefits of $123. In
addition, the Company paid a no-shop fee of $300 to negotiate the
potential acquisition of a company focused on the pre-clinical
stage of developing novel Chimeric Antigen Receptor (CAR) T-cell
therapies based on technology licensed from a leading U.S. cancer
treatment and research institution. Included
in 2021 R&D expenses is an increase of $1,000 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.
General and Administrative Expenses: G&A expenses were
$3,162 for the three months ended June 30, 2022,
a decrease of $43, or 1% from the total G&A expenses for
the three months ended June 30, 2021, of
$3,205. G&A expenses for the three
months ended June 30, 2022, increased $454 primarily due
to an increase in non-cash stock-based compensation expense of
$287 and an increase in other compensation of $167 due to the
addition of a new employee quarter over quarter as well as salary,
bonus and benefits increases. This increase was offset by a
decrease of $533 in professional fees primarily due to a
decrease in proxy costs in 2022.
Six Months Ended June 30, 2022 Financial Results (in
thousands):
For the six months ended June 30, 2022, Atossa had no source of
sustainable revenue and no associated cost of revenue.
Operating Expenses: Total operating expenses were
$11,348 for the six months ended June 30, 2022, which is
an increase of $814 or 8%, from the six months ended
June 30, 2021 of $10,534. Operating expenses for
2022 consisted of R&D expenses of $4,937 and general and
G&A expenses of $6,411. Operating expenses for 2021
consisted of R&D expenses of $5,177, and G&A expenses of
$5,357.
Research and Development Expenses: R&D expenses for
the six months ended June 30, 2022, were $4,937,
a decrease of $240 or 5% from total R&D expenses for
the same period in 2021 of $5,177. R&D expenses
decreased because of a refund of $1,000 from the research
institution that the Company had an exclusive right
to negotiate for the acquisition of the world-wide rights to
two oncology R&D programs. In February 2022, the other party
did not honor its obligation to negotiate with us which lead to a
cancellation of the agreement and refund of the $1,000 previously
paid. Included in 2021 R&D expenses is an increase of
$1,000 attributable the same one-time fee paid in June
2021. Additionally, on June 27, 2022, this decrease was offset
by increased spending on clinical and non-clinical trials of
$434 over the same period in 2021 due to additional drug
manufacturing costs. Stock-based compensation, which is a
non-cash charge, also increased $703 period over
period, and other R&D compensation was up
$202 due to salary, bonus and benefit increases. Professional
expenses also increased $100 during the six months ended June 30,
2022 as compared to the same period in 2021. Finally,
we paid $300 for the exclusive right to negotiate with
a CAR-T Company for us to acquire the company.
General and Administrative Expenses: G&A expenses were
$6,411 for the six months ended June 30, 2022, an
increase of $1,054 or 20% from the total G&A expenses for
the six months ended June 30, 2021, of $5,357. The
increase in G&A expenses for the six months ended
June 30, 2022, is primarily attributable to the increase
in non-cash stock-based compensation expense of $1,020.
Compensation expense also increased $431 due to the addition
of a two new employees year over year as well as salary,
bonus and benefit increases. Legal fees also increased
$147 period over period due to increased patent activity.
These increases are offset by the decrease in professional fees of
$532 due primarily to the reduction of proxy costs
period over period.
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, whether Atossa can
complete acquisitions, 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(amounts in thousands, except for par
value)
|
|
As of June 30, |
|
|
|
|
|
|
|
2022 |
|
|
As of December 31, |
|
Assets |
|
(Unaudited) |
|
|
2021 |
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
125,537 |
|
|
$ |
136,377 |
|
Restricted cash |
|
|
110 |
|
|
|
110 |
|
Prepaid expenses |
|
|
5,304 |
|
|
|
2,488 |
|
Research and development rebate receivable |
|
|
900 |
|
|
|
1,072 |
|
Other current assets |
|
|
1,570 |
|
|
|
1,193 |
|
Total current assets |
|
|
133,421 |
|
|
|
141,240 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
627 |
|
|
|
22 |
|
Total Assets |
|
$ |
134,048 |
|
|
$ |
141,262 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,052 |
|
|
$ |
1,717 |
|
Accrued expenses |
|
|
834 |
|
|
|
204 |
|
Payroll liabilities |
|
|
875 |
|
|
|
1,184 |
|
Other current liabilities |
|
|
31 |
|
|
|
21 |
|
Total current liabilities |
|
|
3,792 |
|
|
|
3,126 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
3,792 |
|
|
|
3,126 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
Preferred stock - $0.001 par value; 10,000 shares authorized; 1
share issued and outstanding as of June 30, 2022 and December 31,
2021 |
|
|
- |
|
|
|
- |
|
Additional paid-in capital - Series B convertible preferred
stock |
|
|
582 |
|
|
|
582 |
|
Common stock - $0.18 par value; 175,000 shares authorized; 126,624
shares issued and outstanding as of June 30, 2022 and December 31,
2021 |
|
|
22,792 |
|
|
|
22,792 |
|
Additional paid-in capital - common stock |
|
|
247,573 |
|
|
|
243,996 |
|
Accumulated deficit |
|
|
(140,691 |
) |
|
|
(129,234 |
) |
Total Stockholders' Equity |
|
|
130,256 |
|
|
|
138,136 |
|
Total Liabilities and Stockholders' Equity |
|
$ |
134,048 |
|
|
$ |
141,262 |
|
|
|
|
|
|
|
|
|
|
ATOSSA THERAPEUTICS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(UNAUDITED)(amounts in
thousands, except for per share amounts)
|
|
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
3,433 |
|
|
$ |
3,799 |
|
|
$ |
4,937 |
|
|
$ |
5,177 |
|
General and
administrative |
|
|
3,162 |
|
|
|
3,205 |
|
|
|
6,411 |
|
|
|
5,357 |
|
Total operating expenses |
|
|
6,595 |
|
|
|
7,004 |
|
|
|
11,348 |
|
|
|
10,534 |
|
Operating loss |
|
|
(6,595 |
) |
|
|
(7,004 |
) |
|
|
(11,348 |
) |
|
|
(10,534 |
) |
Other expense, net |
|
|
(77 |
) |
|
|
(35 |
) |
|
|
(109 |
) |
|
|
(43 |
) |
Loss before income taxes |
|
|
(6,672 |
) |
|
|
(7,039 |
) |
|
|
(11,457 |
) |
|
|
(10,577 |
) |
Income taxes |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss |
|
$ |
(6,672 |
) |
|
$ |
(7,039 |
) |
|
$ |
(11,457 |
) |
|
$ |
(10,577 |
) |
Loss per common share - basic
and diluted |
|
$ |
(0.05 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.10 |
) |
Weighted average shares
outstanding - basic and diluted |
|
|
126,624 |
|
|
|
121,572 |
|
|
|
126,624 |
|
|
|
107,160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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