Atossa Therapeutics Announces Second Quarter 2022 Financial Results and Provides Corporate Update

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

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 View All
Atossa Therapeutics Announces Second Quarter 2022 Financial Results and Provides Corporate Update

SEATTLE, Aug. 08, 2022 (GLOBE NEWSWIRE) — 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 Counsel
Office: (866) 893-4927
kyle.guse@atossainc.com

Investor Relations Contact:
Core IR
Office: (516) 222-2560
ir@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


Primary Logo

Aug 08, 2022

Atossa Therapeutics Announces Second Quarter 2022 Financial Results and Provides Corporate Update

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

Atossa logo

 View All
Atossa Therapeutics Announces Second Quarter 2022 Financial Results and Provides Corporate Update

SEATTLE, Aug. 08, 2022 (GLOBE NEWSWIRE) — 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 Counsel
Office: (866) 893-4927
kyle.guse@atossainc.com

Investor Relations Contact:
Core IR
Office: (516) 222-2560
ir@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


Primary Logo

Aug 08, 2022

Dosing Completed in Part C of Atossa’s Phase 1/2a Study of AT-H201 in Healthy Volunteers

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

Atossa logo

 View All
Dosing Completed in Part C of Atossa’s Phase 1/2a Study of AT-H201 in Healthy Volunteers
Atossa Plans to Initiate a New Development Path in Patients with Compromised Lung-Function Resulting from Cancer Treatment

SEATTLE, July 28, 2022 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS) a clinical stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases with a current focus on breast cancer and COVID-19, today announces it has completed dosing participants in Part C of its Phase 1/2a clinical study of its proprietary inhalation therapy (or, AT-H201) in Australia.

AT-H201 consists of two drugs previously approved by the FDA to treat other diseases. AT-H201 is intended to be inhaled via nebulizer with the goal of preventing or reducing lung injury that may be caused by fibrin deposition, fluid build-up and secondary infection.

Part C of the study involved administering the two drugs in succession in healthy volunteers. The study originally included a Part D which was designed to assess the effects of the treatment regimen in hospitalized COVID-19 patients with moderate illness. However, due to the rapidly shifting COVID-19 treatment landscape and the introduction of effective vaccines limiting hospitalizations, Atossa has evaluated indications for AT-H201 beyond COVID-19 patients, including treating and/or preventing lung injury in patients undergoing certain cancer treatments.

Rather than conducting Part D of the Phase 1/2a clinical study, Atossa now plans to shift the development of AT-H201 to closely align with its oncology focus by continuing the development in patients with compromised lung-function due to the damaging effects of cancer treatment. For example, radiation treatment can lead to radiation induced lung injury, which is poorly treated with current therapies and is often irreversible. Furthermore, radiation damage can limit the overall success of lung cancer treatment leading to a reduction in efficacy and poor disease control. AT-H201 has pharmacological properties to potentially curtail excessive radiation-induced lung injury without compromising standard of care cancer therapy for cancer patients. AT-H201 is designed to prevent and reduce dose-limiting toxicities, and enable a more durable therapeutic tumor response for cancer patients receiving pulmonary radiation.

“We are happy to have completed Parts A, B and C of the clinical trial and look forward to evaluating the results,” said Steven Quay, M.D., Ph.D., CEO and President of Atossa. “With 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 patients with compromised lung-function resulting from radiation may fill a compelling unmet medical need and create more value for our stockholders.” Based on our work to date with AT-H201, we believe we can quickly initiate a clinical study in this setting and we plan to announce our next steps in the fourth quarter,” concluded Dr. Quay.

Radiation Induced Lung Injury (RILI)

RILI is damage to the lungs caused by ionizing radiation administered to treat cancer. RILI is a significant issue for patients undergoing radiation treatment for various forms of cancer and is often irreversible. For instance, RILI 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 RILI is estimated to be greater than 60%. Although Atossa has not finalized the protocol for this new trial we believe RILI affects a significant number of patients across multiple cancer types and there is a meaningful need for new treatments.

About AT-H201

AT-H201 is a proprietary sequential dosing regimen of two previously approved by the FDA to treat other diseases, and by other administration routes. AT-H201 is intended to be inhaled via nebulizer to improve compromised lung function.

The Phase 1/2a study in Australia and other clinical studies must be successfully completed and regulatory approvals must be obtained before AT-H201 can be commercialized. No assurance can be given that the studies will be successful or that regulatory approvals will be obtained.

About Atossa Therapeutics

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need 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 risk and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and anticipated use of proceeds from the offering, 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 and continue 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 neoadjuvant study or reduction of breast density will be approvable endpoints 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.
Charles Butler
Vice President, Investor and Public Relations
charles.butler@atossainc.com


Primary Logo

Jul 28, 2022

Dosing Completed in Part C of Atossa’s Phase 1/2a Study of AT-H201 in Healthy Volunteers

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

Atossa logo

 View All
Dosing Completed in Part C of Atossa’s Phase 1/2a Study of AT-H201 in Healthy Volunteers
Atossa Plans to Initiate a New Development Path in Patients with Compromised Lung-Function Resulting from Cancer Treatment

SEATTLE, July 28, 2022 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS) a clinical stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases with a current focus on breast cancer and COVID-19, today announces it has completed dosing participants in Part C of its Phase 1/2a clinical study of its proprietary inhalation therapy (or, AT-H201) in Australia.

AT-H201 consists of two drugs previously approved by the FDA to treat other diseases. AT-H201 is intended to be inhaled via nebulizer with the goal of preventing or reducing lung injury that may be caused by fibrin deposition, fluid build-up and secondary infection.

Part C of the study involved administering the two drugs in succession in healthy volunteers. The study originally included a Part D which was designed to assess the effects of the treatment regimen in hospitalized COVID-19 patients with moderate illness. However, due to the rapidly shifting COVID-19 treatment landscape and the introduction of effective vaccines limiting hospitalizations, Atossa has evaluated indications for AT-H201 beyond COVID-19 patients, including treating and/or preventing lung injury in patients undergoing certain cancer treatments.

Rather than conducting Part D of the Phase 1/2a clinical study, Atossa now plans to shift the development of AT-H201 to closely align with its oncology focus by continuing the development in patients with compromised lung-function due to the damaging effects of cancer treatment. For example, radiation treatment can lead to radiation induced lung injury, which is poorly treated with current therapies and is often irreversible. Furthermore, radiation damage can limit the overall success of lung cancer treatment leading to a reduction in efficacy and poor disease control. AT-H201 has pharmacological properties to potentially curtail excessive radiation-induced lung injury without compromising standard of care cancer therapy for cancer patients. AT-H201 is designed to prevent and reduce dose-limiting toxicities, and enable a more durable therapeutic tumor response for cancer patients receiving pulmonary radiation.

“We are happy to have completed Parts A, B and C of the clinical trial and look forward to evaluating the results,” said Steven Quay, M.D., Ph.D., CEO and President of Atossa. “With 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 patients with compromised lung-function resulting from radiation may fill a compelling unmet medical need and create more value for our stockholders.” Based on our work to date with AT-H201, we believe we can quickly initiate a clinical study in this setting and we plan to announce our next steps in the fourth quarter,” concluded Dr. Quay.

Radiation Induced Lung Injury (RILI)

RILI is damage to the lungs caused by ionizing radiation administered to treat cancer. RILI is a significant issue for patients undergoing radiation treatment for various forms of cancer and is often irreversible. For instance, RILI 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 RILI is estimated to be greater than 60%. Although Atossa has not finalized the protocol for this new trial we believe RILI affects a significant number of patients across multiple cancer types and there is a meaningful need for new treatments.

About AT-H201

AT-H201 is a proprietary sequential dosing regimen of two previously approved by the FDA to treat other diseases, and by other administration routes. AT-H201 is intended to be inhaled via nebulizer to improve compromised lung function.

The Phase 1/2a study in Australia and other clinical studies must be successfully completed and regulatory approvals must be obtained before AT-H201 can be commercialized. No assurance can be given that the studies will be successful or that regulatory approvals will be obtained.

About Atossa Therapeutics

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need 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 risk and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and anticipated use of proceeds from the offering, 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 and continue 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 neoadjuvant study or reduction of breast density will be approvable endpoints 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.
Charles Butler
Vice President, Investor and Public Relations
charles.butler@atossainc.com


Primary Logo

Jul 28, 2022

Atossa Therapeutics Appoints Biotech Industry Communications Veteran Charles Butler as Vice President, Investor Relations and Public Relations

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

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 View All
Atossa Therapeutics Appoints Biotech Industry Communications Veteran Charles Butler as Vice President, Investor Relations and Public Relations

SEATTLE, June 02, 2022 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company seeking to develop innovative proprietary medicines in areas of significant unmet medical need in oncology and infectious disease with a current focus on breast cancer and COVID-19, today announces the appointment of Charles Butler, a 25-year veteran in the healthcare communications space, as vice president of investor relations and public relations.

“As Atossa continues to develop our pipeline both in breast cancer and COVID-19, the necessity for an in-house strategic manager for our communications has become an important priority and Charles’s extensive experience within the industry as a liaison for both investors and the media make him a valuable asset,” commented Dr. Steven Quay, Atossa’s President and Chief Executive Officer.

Prior to joining Atossa, Mr. Butler spent 10 years at Exelixis, Inc. where he managed all communications from the preclinical through commercial stage for multiple drugs. During his time at Exelixis, he was a part of the team that raised over $1B in equity and business development transactions. Prior to Exelixis, he worked at Ogilvy in New York and London. At Ogilvy he was part of the team that launched multiple blockbuster drugs for several pharmaceutical companies including Merck and Pfizer. While in London, he managed a 25+ person team, overseeing healthcare communications for the United Kingdom and Europe. He has also worked at Castlight Health, ICR, Adverum, Eiger Biopharmaceuticals and IN8bio, Inc.

Mr. Butler graduated from George Washington University with a B.A. in Political Science.

“The unique opportunity to be part of the Atossa team that is working to bring new products to market in breast cancer and other important diseases is exciting. It will allow me to leverage my many years of experience across the communications spectrum in biotechnology. I look forward to collaborating closely with management to ensure its strong message of innovation and patient care are clearly received in this crowded marketplace,” added Mr. Butler.

ABOUT ATOSSA THERAPEUTICS

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to develop innovative proprietary medicines in areas of significant unmet medical need 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 DISCLAIMER STATEMENT

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, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering, 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 and continue 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 or reduction of breast density will be approvable endpoints 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 Counsel
Office: (866) 893-4927
kyle.guse@atossainc.com

INVESTOR RELATIONS CONTACT:
Core IR
Office: (516) 222-2560
ir@atossainc.com


Primary Logo

Jun 02, 2022

Atossa Therapeutics Appoints Biotech Industry Communications Veteran Charles Butler as Vice President, Investor Relations and Public Relations

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

Atossa logo

 View All
Atossa Therapeutics Appoints Biotech Industry Communications Veteran Charles Butler as Vice President, Investor Relations and Public Relations

SEATTLE, June 02, 2022 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company seeking to develop innovative proprietary medicines in areas of significant unmet medical need in oncology and infectious disease with a current focus on breast cancer and COVID-19, today announces the appointment of Charles Butler, a 25-year veteran in the healthcare communications space, as vice president of investor relations and public relations.

“As Atossa continues to develop our pipeline both in breast cancer and COVID-19, the necessity for an in-house strategic manager for our communications has become an important priority and Charles’s extensive experience within the industry as a liaison for both investors and the media make him a valuable asset,” commented Dr. Steven Quay, Atossa’s President and Chief Executive Officer.

Prior to joining Atossa, Mr. Butler spent 10 years at Exelixis, Inc. where he managed all communications from the preclinical through commercial stage for multiple drugs. During his time at Exelixis, he was a part of the team that raised over $1B in equity and business development transactions. Prior to Exelixis, he worked at Ogilvy in New York and London. At Ogilvy he was part of the team that launched multiple blockbuster drugs for several pharmaceutical companies including Merck and Pfizer. While in London, he managed a 25+ person team, overseeing healthcare communications for the United Kingdom and Europe. He has also worked at Castlight Health, ICR, Adverum, Eiger Biopharmaceuticals and IN8bio, Inc.

Mr. Butler graduated from George Washington University with a B.A. in Political Science.

“The unique opportunity to be part of the Atossa team that is working to bring new products to market in breast cancer and other important diseases is exciting. It will allow me to leverage my many years of experience across the communications spectrum in biotechnology. I look forward to collaborating closely with management to ensure its strong message of innovation and patient care are clearly received in this crowded marketplace,” added Mr. Butler.

ABOUT ATOSSA THERAPEUTICS

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to develop innovative proprietary medicines in areas of significant unmet medical need 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 DISCLAIMER STATEMENT

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, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering, 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 and continue 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 or reduction of breast density will be approvable endpoints 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 Counsel
Office: (866) 893-4927
kyle.guse@atossainc.com

INVESTOR RELATIONS CONTACT:
Core IR
Office: (516) 222-2560
ir@atossainc.com


Primary Logo

Jun 02, 2022

Atossa Therapeutics to Present at the H.C. Wainwright Global Hybrid Investment Conference

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

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 View All
Atossa Therapeutics to Present at the H.C. Wainwright Global Hybrid Investment Conference

SEATTLE, May 18, 2022 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company seeking to develop innovative proprietary medicines in areas of significant unmet medical need in oncology and infectious disease with a current focus on breast cancer and COVID-19, today announces that Kyle Guse, Chief Financial Officer and General Counsel, will present a corporate overview at the H.C. Wainwright Global Hybrid Investment Conference. The conference is being held on May 23 – 26, 2022 at the Fontainebleau Hotel in Miami Beach, FL.

Presentation Date: May 24, 2022
Time: 12:30pm ET

Mr. Guse will be available for one-on-one meetings. To request a meeting and to register for the conference, click here:

In-Person

Virtual

ABOUT ATOSSA THERAPEUTICS

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to develop innovative proprietary medicines in areas of significant unmet medical need 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 DISCLAIMER STATEMENT

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, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering, 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 and continue 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 or reduction of breast density will be approvable endpoints 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 Counsel
Office: (866) 893-4927
kyle.guse@atossainc.com

INVESTOR RELATIONS CONTACT:
Core IR
Office: (516) 222-2560
ir@atossainc.com


Primary Logo

May 18, 2022

Atossa Therapeutics to Present at the H.C. Wainwright Global Hybrid Investment Conference

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

Atossa logo

 View All
Atossa Therapeutics to Present at the H.C. Wainwright Global Hybrid Investment Conference

SEATTLE, May 18, 2022 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company seeking to develop innovative proprietary medicines in areas of significant unmet medical need in oncology and infectious disease with a current focus on breast cancer and COVID-19, today announces that Kyle Guse, Chief Financial Officer and General Counsel, will present a corporate overview at the H.C. Wainwright Global Hybrid Investment Conference. The conference is being held on May 23 – 26, 2022 at the Fontainebleau Hotel in Miami Beach, FL.

Presentation Date: May 24, 2022
Time: 12:30pm ET

Mr. Guse will be available for one-on-one meetings. To request a meeting and to register for the conference, click here:

In-Person

Virtual

ABOUT ATOSSA THERAPEUTICS

Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to develop innovative proprietary medicines in areas of significant unmet medical need 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 DISCLAIMER STATEMENT

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, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering, 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 and continue 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 or reduction of breast density will be approvable endpoints 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 Counsel
Office: (866) 893-4927
kyle.guse@atossainc.com

INVESTOR RELATIONS CONTACT:
Core IR
Office: (516) 222-2560
ir@atossainc.com


Primary Logo

May 18, 2022

Atossa Therapeutics Announces First Quarter 2022 Financial Results and Provides Corporate Update

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

Atossa logo

 View All
Atossa Therapeutics Announces First Quarter 2022 Financial Results and Provides Corporate Update

SEATTLE, May 09, 2022 (GLOBE NEWSWIRE) — 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 March 31, 2022, and provides an update on recent company developments.

Key developments from Q1 2022 and to date include:

  • Received issuance of key U.S. patent covering Endoxifen directed to compositions of storage-stable Endoxifen and methods of treating hormone-dependent breast disorders using the storage-stable Endoxifen.
  • Announced planned U.S. Phase 2 clinical study of Endoxifen in the neoadjuvant setting (prior to surgery) to compare Endoxifen to standard of care in premenopausal women with breast cancer. A CRO has been engaged to work on this study and the Company also intends to retain a leading U.S. research institution to help manage the study. The Company anticipates submitting an IND to the FDA in the second quarter of 2022.
  • Completed Part B (second of four parts) of Phase 1b/2a clinical study of AT-H201 in Australia

“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,” commented Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Our Phase 2 study in women with measurable breast density continues to enroll participants in Stockholm and we have been preparing to submit a request (IND) to the FDA this quarter to open a Phase 2 study in the neoadjuvant setting here in the Unites States. We began 2022 with significant progress in our COVID-19 program, both initiating and completing key parts of our Phase1b/2a trial in Australia for AT-H201, and we have now completed the first two parts of that study.”

Quarter Ended March 31, 2022 Financial Results (in thousands):

For the quarter ended March 31, 2022, Atossa has no source of sustainable revenue and no associated cost of revenue.

As of March 31, 2022, the Company had cash, cash equivalents and restricted cash of approximately $131,596.

Operating Expenses:
Total operating expenses were $4,747 for the three months ended March 31, 2022, which is an increase of $1,216 or 34%, from the three months ended March 31, 2021. Operating expenses for 2022 consisted of research and development (R&D) expenses of $1,499 and general and administrative (G&A) expenses of $3,248. Operating expenses for 2021 consisted of R&D expenses of $1,379, and G&A expenses of $2,152.

Research and Development Expenses:
R&D expenses for the three months ended March 31, 2022, were $1,499, an increase of $120 or 9% from total R&D expenses for the same period in 2021 of $1,379. The increase in R&D expense is attributed to increased spending on clinical and non-clinical trials of $584 over 2021 due to additional drug manufacturing costs. Stock-based compensation, which is a non-cash charge, also increased $433 quarter over quarter, and other R&D compensation was up $79 due to salary bonus and benefit increases quarter over quarter. The increase in R&D was offset by 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 we paid them.

General and Administrative Expenses:
G&A expenses were $3,248 for the three months ended March 31, 2022, an increase of $1,096, or 51% from the total G&A expenses for the three months ended March 31, 2021, of $2,152. The increase in G&A expenses for the three months ended March 31, 2022, is primarily attributable to non-cash stock-based compensation expense of $734. Other compensation also increased $264 due to the addition of a new employee quarter over quarter as well as salary, bonus and benefit increases. Legal fees also increased $124 quarter over quarter due to increased patent activity.

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 Counsel
Office: (866) 893-4927
kyle.guse@atossainc.com

Investor Relations Contact:
Core IR
Office: (516) 222-2560
ir@atossainc.com

Source: Atossa Therapeutics, Inc.

ATOSSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except for par value)

As of March 31,
2022 As of December 31,
Assets (Unaudited) 2021
Current assets
Cash and cash equivalents $ 131,486 $ 136,377
Restricted cash 110 110
Prepaid expenses 3,874 2,488
Research and development rebate receivable 668 1,072
Other current assets 710 1,193
Total current assets 136,848 141,240
Other assets 630 22
Total Assets $ 137,478 $ 141,262
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 1,596 $ 1,717
Accrued expenses 120 204
Payroll liabilities 593 1,184
Other current liabilities 13 21
Total current liabilities 2,322 3,126
Total Liabilities 2,322 3,126
Commitments and contingencies
Stockholders’ equity
Preferred stock – $0.001 par value; 10,000 shares authorized; 1 share issued and outstanding as of March 31, 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 March 31, 2022 and December 31, 2021 22,792 22,792
Additional paid-in capital – common stock 245,802 243,996
Accumulated deficit (134,020 ) (129,234 )
Total Stockholders’ Equity 135,156 138,136
Total Liabilities and Stockholders’ Equity $ 137,478 $ 141,262


ATOSSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(amounts in thousands, except for per share amounts)

For the Three Months Ended March 31,
2022 2021
Operating expenses
Research and development $ 1,499 $ 1,379
General and administrative 3,248 2,152
Total operating expenses 4,747 3,531
Operating loss (4,747 ) (3,531 )
Other expense, net (39 ) (7 )
Loss before income taxes (4,786 ) (3,538 )
Income taxes
Net loss $ (4,786 ) $ (3,538 )
Loss per common share – basic and diluted $ (0.04 ) $ (0.04 )
Weighted average shares outstanding – basic and diluted 126,624 92,587


Primary Logo

May 09, 2022

Atossa Therapeutics Announces First Quarter 2022 Financial Results and Provides Corporate Update

Regulatory Approval To Open Clinical Study of AT-H201 in Australia

Atossa logo

 View All
Atossa Therapeutics Announces First Quarter 2022 Financial Results and Provides Corporate Update

SEATTLE, May 09, 2022 (GLOBE NEWSWIRE) — 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 March 31, 2022, and provides an update on recent company developments.

Key developments from Q1 2022 and to date include:

  • Received issuance of key U.S. patent covering Endoxifen directed to compositions of storage-stable Endoxifen and methods of treating hormone-dependent breast disorders using the storage-stable Endoxifen.
  • Announced planned U.S. Phase 2 clinical study of Endoxifen in the neoadjuvant setting (prior to surgery) to compare Endoxifen to standard of care in premenopausal women with breast cancer. A CRO has been engaged to work on this study and the Company also intends to retain a leading U.S. research institution to help manage the study. The Company anticipates submitting an IND to the FDA in the second quarter of 2022.
  • Completed Part B (second of four parts) of Phase 1b/2a clinical study of AT-H201 in Australia

“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,” commented Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Our Phase 2 study in women with measurable breast density continues to enroll participants in Stockholm and we have been preparing to submit a request (IND) to the FDA this quarter to open a Phase 2 study in the neoadjuvant setting here in the Unites States. We began 2022 with significant progress in our COVID-19 program, both initiating and completing key parts of our Phase1b/2a trial in Australia for AT-H201, and we have now completed the first two parts of that study.”

Quarter Ended March 31, 2022 Financial Results (in thousands):

For the quarter ended March 31, 2022, Atossa has no source of sustainable revenue and no associated cost of revenue.

As of March 31, 2022, the Company had cash, cash equivalents and restricted cash of approximately $131,596.

Operating Expenses:
Total operating expenses were $4,747 for the three months ended March 31, 2022, which is an increase of $1,216 or 34%, from the three months ended March 31, 2021. Operating expenses for 2022 consisted of research and development (R&D) expenses of $1,499 and general and administrative (G&A) expenses of $3,248. Operating expenses for 2021 consisted of R&D expenses of $1,379, and G&A expenses of $2,152.

Research and Development Expenses:
R&D expenses for the three months ended March 31, 2022, were $1,499, an increase of $120 or 9% from total R&D expenses for the same period in 2021 of $1,379. The increase in R&D expense is attributed to increased spending on clinical and non-clinical trials of $584 over 2021 due to additional drug manufacturing costs. Stock-based compensation, which is a non-cash charge, also increased $433 quarter over quarter, and other R&D compensation was up $79 due to salary bonus and benefit increases quarter over quarter. The increase in R&D was offset by 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 we paid them.

General and Administrative Expenses:
G&A expenses were $3,248 for the three months ended March 31, 2022, an increase of $1,096, or 51% from the total G&A expenses for the three months ended March 31, 2021, of $2,152. The increase in G&A expenses for the three months ended March 31, 2022, is primarily attributable to non-cash stock-based compensation expense of $734. Other compensation also increased $264 due to the addition of a new employee quarter over quarter as well as salary, bonus and benefit increases. Legal fees also increased $124 quarter over quarter due to increased patent activity.

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 Counsel
Office: (866) 893-4927
kyle.guse@atossainc.com

Investor Relations Contact:
Core IR
Office: (516) 222-2560
ir@atossainc.com

Source: Atossa Therapeutics, Inc.

ATOSSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except for par value)

As of March 31,
2022 As of December 31,
Assets (Unaudited) 2021
Current assets
Cash and cash equivalents $ 131,486 $ 136,377
Restricted cash 110 110
Prepaid expenses 3,874 2,488
Research and development rebate receivable 668 1,072
Other current assets 710 1,193
Total current assets 136,848 141,240
Other assets 630 22
Total Assets $ 137,478 $ 141,262
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 1,596 $ 1,717
Accrued expenses 120 204
Payroll liabilities 593 1,184
Other current liabilities 13 21
Total current liabilities 2,322 3,126
Total Liabilities 2,322 3,126
Commitments and contingencies
Stockholders’ equity
Preferred stock – $0.001 par value; 10,000 shares authorized; 1 share issued and outstanding as of March 31, 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 March 31, 2022 and December 31, 2021 22,792 22,792
Additional paid-in capital – common stock 245,802 243,996
Accumulated deficit (134,020 ) (129,234 )
Total Stockholders’ Equity 135,156 138,136
Total Liabilities and Stockholders’ Equity $ 137,478 $ 141,262


ATOSSA THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(amounts in thousands, except for per share amounts)

For the Three Months Ended March 31,
2022 2021
Operating expenses
Research and development $ 1,499 $ 1,379
General and administrative 3,248 2,152
Total operating expenses 4,747 3,531
Operating loss (4,747 ) (3,531 )
Other expense, net (39 ) (7 )
Loss before income taxes (4,786 ) (3,538 )
Income taxes
Net loss $ (4,786 ) $ (3,538 )
Loss per common share – basic and diluted $ (0.04 ) $ (0.04 )
Weighted average shares outstanding – basic and diluted 126,624 92,587


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May 09, 2022