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

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

SEATTLE, Nov. 07, 2022 — Atossa Therapeutics, Inc. (Nasdaq: ATOS), today announces financial results for the fiscal quarter ended September 30, 2022, and provides an update on recent company developments. Atossa is a clinical-stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology with a current focus on breast cancer and lung injury caused by cancer treatments.

Key developments from Q3 2022 and to date include:

  • Received FDA authorization from FDA to initiate its Phase 2 study of neoadjuvant (Z)-endoxifen in premenopausal women with ER+/HER2- breast cancer.
  • Invested in a privately-held Dynamic Cell Therapies, a company focused on CAR-T therapies as an important step in pursuing its strategy to develop CAR-T therapies or adjacent opportunities within the immuno-oncology space.
  • 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 is now developing for patients with compromised lung function due to the damaging effects of cancer treatment.

“We continue to make progress with our (Z)-endoxifen programs. In particular, our Phase 2 study of neoadjuvant (Z)-endoxifen for pre-menopausal women with ER+/HER2- breast cancer was authorized by FDA to begin in the United States, and we plan to initiate the study during the fourth quarter of this year. We are re-aligning our strategy to address new avenues in the field of oncology. We have altered our approach to the development of AT-H201 in cancer patients with compromised lung-function resulting from cancer treatment, and are beginning to explore the possibility of pursuing immune-oncology programs. In the meantime, we will continue our current programs and will provide progress updates as they become available,” commented Dr. Steven Quay, Atossa’s President and Chief Executive Officer.

Quarter Ended September 30, 2022 Financial Results (in thousands):

As of September 30, 2022, the Company had cash, cash equivalents and restricted cash of approximately $117,477.

Revenue and Cost of Revenue: For the three months ended September 30, 2022 and 2021, we had no source of revenue and no associated cost of revenue.

Operating Expenses: Total operating expenses were $8,205 for the three months ended September 30, 2022, which is an increase of $3,047 or 59% from operating expenses for the three months ended September 30, 2021 of $5,158. Operating expenses for the three months ended September 30, 2022 consisted of research and development (R&D) expenses of $5,160 and general and administrative (G&A) expenses of $3,045. Operating expenses for the three months ended September 30, 2021 consisted of R&D expenses of $2,206, and G&A expenses of $2,952. The basis for factors contributing to the increased operating expenses in the three months ended September 30, 2022 are explained below.

Research and Development Expenses: R&D expenses for the three months ended September 30, 2022 were $5,160, an increase of $2,954 or 134% from total R&D expenses for the same period in 2021 of $2,206. The increase in R&D expenses was primarily driven by increases in clinical and non-clinical trial costs as well as drug formulation and analysis costs of $2,475. Stock-based compensation expense also increased $62 compared to the prior year period, and other R&D compensation expense increased $85 due to salary, bonus, and benefit increases.

General and Administrative Expenses: G&A expenses were $3,045 for the three months ended September 30, 2022, an increase of $93 or 3% from the total G&A expenses of $2,952 for the three months ended September 30, 2021. The increase in G&A expenses was primarily driven by an increase in legal fees, professional fees and other expenses of $159 for the three months ended September 30, 2022. G&A expenses also increased in part due to an increase in salary, bonus, and benefits of $123, which was offset by a decrease in stock-based compensation expense of $190.

Nine Months Ended September 30, 2022 Financial Results (in thousands):

Revenue and Cost of Revenue: For the nine months ended September 30, 2022 and 2021, we had no source of revenue and no associated cost of revenue.

Operating Expenses: Total operating expenses were $19,553 for the nine months ended September 30, 2022, which is an increase of $3,860 or 25% from operating expenses for the nine months ended September 30, 2021 of $15,693. Operating expenses for the nine months ended September 30, 2022 consisted of R&D expenses of $10,097 and G&A expenses of $9,456. Operating expenses for the nine months ended September 30, 2021 consisted of R&D expenses of $7,383 and G&A expenses of $8,310. The basis for factors contributing to the increased operating expenses in the nine months ended September 30, 2022 are explained below.

Research and Development Expenses: R&D expenses for the nine months ended September 30, 2022 were $10,097, an increase of $2,714 or 37% from total R&D expenses for the same period in 2021 of $7,383. R&D expenses increased due to an increase in spending on clinical and non-clinical trials of $2,910. Compared to the prior year period, stock-based compensation expense also increased $763, and other R&D compensation expense increased $288 due to salary, bonus, and benefit increases in the nine months ended September 30, 2022. Professional expenses also increased $430 during the nine months ended September 30, 2022, as compared to the same period in 2021. The increases in R&D expenses were offset in part by a refund of $1,000 from the research institution with which 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. In the nine months ended September 30, 2021, R&D expenses included $1,000 attributable the same one-time fee, which was paid in June 2021. Finally, on June 27, 2022, we paid $300 for the exclusive right to negotiate with a CAR-T Company.

General and Administrative Expenses: G&A expenses were $9,456 for the nine months ended September 30, 2022, an increase of $1,146 or 14% from the total G&A expenses for the nine months ended September 30, 2021 of $8,310. The increase in G&A expenses for the nine months ended September 30, 2022 was primarily due to the increase in stock-based compensation expense of $832. Compensation expense also increased $554 due to salary, bonus, and benefit increases related to the addition of employees in the nine months ended September 30, 2022. Legal fees also increased $321 compared to the prior year period due to increased patent prosecution activity. These increases are offset in part by a decrease in professional fees and other expenses of $562 due primarily to the reduction of proxy solicitation costs compared to the prior year period.

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 with a current focus on breast cancer and lung injury caused by cancer treatments. 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 and (Z)-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 breast density, Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for (Z)-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 September 30,
2022 As of December 31,
(Unaudited) 2021
Assets
Current assets
Cash and cash equivalents $ 117,367 $ 136,377
Restricted cash 110 110
Prepaid expenses 5,107 2,488
Research and development rebate receivable 610 1,072
Other current assets 201 1,193
Total current assets 123,395 141,240
Deposit on investment in equity securities 2,700
Other assets 629 22
Total Assets $ 126,724 $ 141,262
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 1,653 $ 1,717
Accrued expenses 117 204
Payroll liabilities 1,071 1,184
Other current liabilities 27 21
Total current liabilities 2,868 3,126
Total Liabilities 2,868 3,126
Commitments and contingencies
Stockholders’ equity
Series B convertible preferred stock – $0.001 par value; 10,000 shares authorized; 1 share issued and outstanding as of September 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 September 30, 2022 and December 31, 2021 22,792 22,792
Additional paid-in capital – common stock 249,239 243,996
Accumulated deficit (148,703 ) (129,234 )
Accumulated other comprehensive loss (54 )
Total Stockholders’ Equity 123,856 138,136
Total Liabilities and Stockholders’ Equity $ 126,724 $ 141,262


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

For the Three Months Ended September 30, For the Nine Months Ended September 30,
2022 2021 2022 2021
Operating expenses
Research and development $ 5,160 $ 2,206 $ 10,097 $ 7,383
General and administrative 3,045 2,952 9,456 8,310
Total operating expenses 8,205 5,158 19,553 15,693
Operating loss (8,205 ) (5,158 ) (19,553 ) (15,693 )
Other income (expense), net 194 (39 ) 84 (81 )
Loss before income taxes (8,011 ) (5,197 ) (19,469 ) (15,774 )
Income taxes
Net loss (8,011 ) (5,197 ) (19,469 ) (15,774 )
Foreign currency translation adjustment (54 ) (54 )
Comprehensive loss $ (8,065 ) $ (5,197 ) $ (19,523 ) $ (15,774 )
Loss per share of common stock – basic and diluted $ (0.06 ) $ (0.04 ) $ (0.15 ) $ (0.14 )
Weighted average shares outstanding – basic and diluted 126,624 126,538 126,624 113,690


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Atossa Therapeutics, Inc. to Acquire Stake in Privately Held Dynamic Cell Therapies as Part of Overall CAR-T Strategy

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

SEATTLE, Nov. 01, 2022 — Atossa Therapeutics, Inc. (Nasdaq: ATOS), announces today that it is investing in privately-held developer of CAR-T therapies, Dynamic Cell Therapies, Inc. (DCT). Atossa is a clinical-stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology with a current focus on breast cancer and lung injury caused by cancer treatments.

“This investment in DCT is an important step in pursuing our strategy to develop CAR-T therapies or adjacent opportunities within the immuno-oncology space,” commented Steven Quay, M.D., Ph.D., Atossa’s CEO, Chairman and President. “We believe that as an active investor in the development of DCT we will be well positioned to evaluate future opportunities while strategically managing our cash position.”

Atossa will acquire shares equal to 19.99% of the outstanding capital stock of DCT as of today for a cash payment of $2 million (in addition to $3 million previously paid to DCT). The transaction is expected to close in the fourth quarter.

About Dynamic Cell Therapies

Dynamic Cell Therapies is venture capital backed and based in Boston, MA. DCT is in the pre-clinical phase of developing controllable CAR-T cells to address difficult-to-treat cancers. Its platform technology of dynamic control of engineered T-cells is designed to improve the safety, efficacy, and durability of CAR-T cell therapies. This system should find initial applications in hematological cancers, with future approaches in solid tumors and autoimmune diseases. The company’s platform technology uncouples tumor targeting from CAR-T cell activation. Each CAR-T cell recognizes an inert small molecule. This small molecule is conjugated to a tumor-specific antibody. By dosing a small molecule-antibody conjugate, the physician could dynamically control CAR-T cell activity and potentially minimize the risk of life-threatening side effects. Increasing the dose of the small molecule-antibody conjugate should strengthen the immune attack against tumor cells. In addition, the same small molecule can be coupled to different tumor targeting antibodies, allowing the physician to maximize on-target on-tumor efficacy and reduce off-tumor toxicities. To learn more, please visit www.dynamiccelltherapies.com.

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 with a current focus on breast cancer and lung injury caused by cancer treatments.

For more information, please visit www.atossatherapeutics.com

Contact:

Atossa Therapeutics, Inc.
Kyle Guse, General Counsel and Chief Financial Officer
kyle.guse@atossainc.com


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Atossa Therapeutics, Inc. Announces Appointment of Pharma Industry Veteran Richard Graydon, M.D., Ph.D.

Regulatory Approval To Open Clinical Study of AT-H201 in Australia
Oversaw FDA approval of CAR-T/CAR-NK cell therapy, ADCs, and small molecule/targeted therapies for hematology-oncology diseases

SEATTLE, Oct. 25, 2022 — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology, with a current focus on breast cancer and adjunctive treatments for cancer radiotherapy, announces today that it has retained Richard Graydon, M.D., Ph.D. as interim chief medical officer. Dr. Graydon will devote all of his professional time to the Atossa clinical programs.

Prior to joining Atossa, Dr. Graydon served as Senior Director of Clinical Development at Johnson and Johnson where he was responsible for leading compound development and clinical trial programs for Janssen Pharmaceuticals. At Janssen, he oversaw the early to late-stage development and the 2022 approval of BCMA-directed CAR T-Cell therapy (cilta-cel) for Multiple Myeloma, as well as daratumumab, imbruvica, siltuximab and other compounds for solid tumor and hematological malignancies. Previously, he held the role of Director of Clinical Development at Daiichi Sankyo, Inc., where he led the early and late-stage development of the small molecule targeted therapy quizartinib for FLT3-positive Acute Myeloid Leukemia. Additionally, he led the early-stage development of the MDM2 inhibitor milademetan in hematological malignancies and liposarcomas. Dr. Graydon spent time in clinical practice following completion of his specialty training in hematology and oncology at Harvard Massachusetts General Hospital. He earned his M.D. and Ph.D. at Stanford University, and undergraduate degree in Chemical Engineering at Cornell University. Dr. Graydon is the author of The Genetic Risks of Cancer: The Effects of DNA, Genomics and Inheritance on Aging and Survival.

“We are privileged to welcome Richard to Atossa, where his deep experience in CAR T cell therapy fits well with our current strategic direction as we explore our opportunities in cell therapy,” said Steven Quay, M.D., Ph.D., Atossa’s Chairman, CEO and President. “We look forward to collaborating with Richard to assess our strongest options and develop a pathway that provides our shareholders with strong results and enhanced shareholder value.”

“I’m looking forward to collaborating with Atossa’s management team and board of directors as we continue to develop the Company’s Phase 2 oral Endoxifen program for breast cancer and identify new opportunities for Atossa in cell therapy,” added Dr. Graydon.

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, with a current focus on breast cancer and adjunctive treatments for cancer radiotherapy.

For more information, please visit www.atossatherapeutics.com

Contact:

Atossa Therapeutics, Inc.
Kyle Guse, General Counsel and Chief Financial Officer
kyle.guse@atossainc.com


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Atossa Therapeutics, Inc. Receives Authorization from FDA to Initiate its Phase 2 Study of Neoadjuvant (Z)-endoxifen in Premenopausal Women with ER+/HER2- Breast Cancer

Regulatory Approval To Open Clinical Study of AT-H201 in Australia
Atossa to begin Phase 2 Study of (Z)-endoxifen in 4th Quarter

SEATTLE, Oct. 24, 2022 — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to develop innovative medicines in areas of significant unmet medical need in oncology with a current focus on breast cancer, announced today that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and authorized initiation of its Phase 2 neoadjuvant clinical study of (Z)-endoxifen in premenopausal women with early-stage estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer. This is the first study of Atossa’s proprietary (Z)-endoxifen in the United States.

At this time, Atossa also announced that it is discontinuing its COVID-19 program (AT-301) so that it can refocus resources on this critical study in breast cancer.

“Continuing the development of our proprietary (Z)-endoxifen here in the United States has been a key goal which builds on the recent issuance of a U.S. patent for our proprietary (Z)-endoxifen and results from our Phase 2 “window-of-opportunity” study in Australia,” commented Steven Quay, M.D., Ph.D., Atossa’s CEO, Chairman and President. “We are excited to have engaged Dr. Matthew Goetz, the Erivan K. Haub Family Professor of Cancer Research Honoring Richard F. Emslander, M.D. at Mayo Clinic and Director of the Mayo Clinic Breast Cancer SPORE, as the lead principal investigator for this multi-center study. We look forward to opening the study in the fourth quarter.”

About the Study

The study, “A Randomized Phase 2 Noninferiority Trial of (Z)-endoxifen and Exemestane + Goserelin as Neoadjuvant Treatment in Premenopausal Women with ER+/HER2- Breast Cancer”, or also known as “EVANGELINE,” is an open-label, randomized, Phase 2 study designed to investigate (Z)-endoxifen for the neoadjuvant treatment of premenopausal women ages 18 and older with early stage (Grade 1 or 2) ER+/HER2- breast cancer. InClin Inc., a full-service Contract Research Organization, has been contracted to execute this study.

This study is a multicenter (approximately 25 sites) study in United States and will enroll about 175 patients and is designed with two cohorts: a PK Run-In Cohort to investigate pharmacokinetics and identify a dose for the Treatment Cohort and a Treatment Cohort to investigate the safety and efficacy of (Z)-endoxifen compared with a prospective control (exemestane + goserelin, two drugs often used in combination to treat this patient population).

The primary objective of the study is to assess whether the endocrine sensitive disease rate at 4 weeks with (Z)-endoxifen is non-inferior to exemestane plus goserelin in premenopausal women with ER+/HER2- breast cancer. Endocrine sensitivity, or the effect of endocrine therapy on the tumor, will be measured by Ki-67%, a biomarker for tumor cell proliferation. Ki-67 is known to be prognostic for 5-year disease-free survival in the neoadjuvant endocrine treatment of ER+/HER2- breast cancer. The neoadjuvant setting of this study will allow Atossa to investigate several translational endpoints using paired tumor samples.

Patients will be enrolled with the intent of surgical treatment in the involved breast(s) after completing neoadjuvant study treatment. Patients will receive neoadjuvant study treatment for up to six months. Surgery will be performed within seven days of the last dose of study treatment.

About Premenopausal Patients with ER+/HER2- Breast Cancer

Breast cancer is the most frequently diagnosed cancer in premenopausal women worldwide. It is estimated that almost half of the cancers that occur in women aged 15-49 is breast cancer. An overwhelming majority (75%) of premenopausal breast cancer falls under luminal A (ER+/HER2-) or B (ER+/HER2+) subtypes. Ovarian function suppression, when combined with either tamoxifen or an aromatase inhibitor, is the standard of care for the endocrine management of premenopausal ER+/HER2- breast cancer.

About (Z)-Endoxifen

(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies by others have demonstrated that the anti-estrogenic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein.

Atossa has developed a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions may render (Z)-endoxifen inactive. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. We currently are studying our (Z)-endoxifen in healthy women with measurable breast density and premenopausal women with ER+/HER2- breast cancer.

Atossa has been issued U.S. Patent No. 11,261,151, titled “Methods for Making and Using Endoxifen” which is directed to compositions of storage-stable (Z)-endoxifen and methods of treating hormone-dependent breast disorders using the storage-stable (Z)-endoxifen. This patent is not expected to expire until 2038.

Update on Ongoing Phase 2 Study of (Z)-Endoxifen Phase 2 Study in Stockholm

The Company has continued to make steady progress with its ongoing study of (Z)-endoxifen in premenopausal women with measurable breast density in Stockholm, Sweden. It has now enrolled approximately 40% of the subjects in that study, which puts Atossa on track to completing enrollment of all 240 participants in the second half of 2023.

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 with a current focus on breast cancer.

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 and (Z)-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 breast density or in Ki-67 or any other result from a neoadjuvant study is an approvable endpoint for (Z)-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.

Contact:
Atossa Therapeutics, Inc.
Kyle Guse, General Counsel and Chief Financial Officer
kyle.guse@atossainc.com


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