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SEATTLE, March 22, 2023 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in cancer, today announced financial results for the fiscal quarter and fiscal year ended December 31, 2022 and provided an update on recent company developments.

Key developments from Q4 2022 and year to date include:

Initiation and First Patient Dosed in Phase 2 EVANGELINE Study – EVANGELINE (Endoxifen Versus exemestANe GosEreLIn), is our Phase 2 randomized non-inferiority study of (Z)-endoxifen compared to exemestane plus goserelin as a neoadjuvant treatment for premenopausal women with Grade 1 or 2 ER+ / HER2- breast cancer. Participants receive neoadjuvant treatment for up to six months, followed by surgery. Several FDA-approved neoadjuvant therapies exist for ER- breast cancers, but few exist for ER+ patients, which account for approximately 78% of breast cancers. We expect to enroll approximately 175 patients at up to 25 sites across the United States.

Continued Enrollment in Phase 2 Karisma-Endoxifen Study – The Karisma-Endoxifen study is our randomized, double-blind, placebo-controlled trial of healthy, pre-menopausal women with increased breast density. The treatment cohort receives daily doses of (Z)-endoxifen for six months, over the course of which mammograms will be conducted to measure reduction in mammographic breast density (MBD). Patients will also be given a mammogram at 24 months to assess the durability of the MBD changes. MBD affects more than 10 million women in the United States and many millions more worldwide. Increased MBD reduces the ability of mammograms to detect cancer. Studies have also shown that women with MBD have an increased risk of developing breast cancer and that the higher the MBD, the higher the incidence of breast cancer. We expect to fully enroll the study by the end of 2023.

Initiation of New Study Arm in the Ongoing Phase 2 I-SPY 2 Clinical Trial – (Z)-endoxifen is being evaluated in a new study arm of the ongoing I-SPY 2 clinical trial. The I-SPY 2 trial evaluates neoadjuvant treatments for locally advanced breast cancer and is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. Approximately 20 patients will be treated with (Z)-endoxifen for up to 24 weeks prior to surgery.

Additional Intellectual Property Protection for (Z)-endoxifen – The United States Patent and Trademark Office granted a new patent (No. 11,572,334) directed to (Z)-endoxifen encapsulated in an enteric capsule. Enteric capsules have an acid resistant coating to prevent them from dissolving when they pass through the stomach. Enteric capsules are dissolved when they pass through an alkaline environment, which is usually when they reach the small intestine. Delivering oral (Z)-endoxifen via an enteric capsule prevents breakdown of the endoxifen in the stomach. This patent further reinforces Atossa’s broad Intellectual Property portfolio related to (Z)-endoxifen.

Investment in Dynamic Cell Therapies, Inc. (DCT) – DCT is a privately held, venture capital backed developer of CAR-T therapies 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. Our investment totaled $4.7 million and resulted in Atossa owning approximately 19% of the outstanding capital stock of DCT.

“Our focus remains on both helping reduce the incidence of breast cancer and changing the treatment paradigm for patients who are not benefiting from, or are unable to tolerate, currently approved therapies,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “With a strong balance sheet and three Phase 2 trials underway, we are well positioned to continue accelerating the development of (Z)-endoxifen, which we feel has the potential to address significant unmet needs across the continuum of breast cancer.”

YEAR ENDED DECEMBER 31, 2022, FINANCIAL RESULTS (IN THOUSANDS)

As of December 31, 2022, we had cash, cash equivalents and restricted cash of $111,000.

Results of Operations

Comparison of Years Ended December 31, 2022 and 2021

Revenue and Cost of Revenue:

For the years ended December 31, 2022 and 2021, we have no source of sustainable revenue and no associated cost of revenue.

Operating Expenses:

The following table provides a breakdown of major categories within Research and Development (R&D) and General and Administrative (G&A) expenses for the years ended December 31, 2022 and 2021, together with the dollar change in those categories:

Total operating expenses were $27,691 for the year ended December 31, 2022, which was an increase of $7,170, or 35% from the year ended December 31, 2021. Operating expenses for 2022 consisted of R&D expenses of $15,083 and G&A expenses of $12,608. Operating expenses for 2021 consisted of R&D expenses of $9,210 and G&A expenses of $11,311. Factors contributing to the increased operating expenses in the year ended December 31, 2022 are explained below.

R&D Expenses: R&D expenses for the year ended December 31, 2022, were $15,083, an increase of $5,873 or 64% from total R&D expenses for the year ended December 31, 2021 of $9,210. Key changes were as follows:

• The increase in R&D expense was attributed primarily to increased spending on clinical and non-clinical trials of $5,569 compared to the prior year period due to additional pre-clinical toxicology studies in our (Z)-endoxifen and AT-H201 programs as well as increased trial costs and manufacturing expenses for (Z)-endoxifen.

• R&D compensation increased $393 in 2022 compared to the prior year period due to increased headcount, salary, bonuses and benefits during 2022.

• Stock-based compensation, which is a non-cash charge, increased $802 due to the increased number of options being expensed as well as the weighted average fair value of options amortizing in 2022 was higher compared to the prior year period.

• Professional fees increased $788 compared to the prior year period, due primarily to a CAR-T technology market analysis performed during 2022.

• In 2022, the Company received a refund of $1,000 from the research institution with which the Company had an exclusive right to negotiate for the acquisition of the worldwide rights to two oncology R&D programs. In 2021, R&D expenses included $1,000 attributable to the same one-time exclusivity fee. Finally, in 2022, we paid $300 for the exclusive right to negotiate with another CAR-T Company. Net, the exclusivity agreements caused a decrease in expenses of $1,700 compared to the prior year period.

  G&A Expenses: G&A expenses were $12,608 for the year ended December 31, 2022, an increase of $1,297, or 11% from total G&A expenses for the year ended December 31, 2021 of $11,311. Key changes were as follows:

• The increase in G&A expense for the year ended December 31, 2022 compared to the prior year period, was in part attributable to the increase in compensation expense of $663 in 2022 due to an increase in headcount, hourly wages, salaries and bonus accruals.

• Non-cash stock-based compensation expense also increased by $719 due to the increased number of options being expensed as well as the weighted average fair value of options amortizing in 2022 was higher compared to the prior year period.

• Professional fees decreased by $692 in 2022 compared to the prior year period, due primarily to a decrease in proxy costs for investor outreach.

• Legal fees increased $601 in 2022 compared to the prior year period, due to higher patent activity in 2022 for (Z)-endoxifen and our immunotherapy research.

  Interest Income: Interest income was $877 for the year ended December 31, 2022 compared to the prior year period of $6. The increase is due to the investment of an additional $50,000 in a money market account during 2022 and higher average interest rates for the year ended December 31, 2022 compared to 2021.

ABOUT ATOSSA THERAPEUTICS
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing 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

CONTACTS:
Kyle Guse
General Counsel and Chief Financial Officer
kyle.guse@atossainc.com

Eric Van Zanten
VP, Investor and Public Relations
610-529-6219
eric.vanzanten@atossainc.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 (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.

SEATTLE and SAN FRANCISCO, March 21, 2023 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology, and Quantum Leap Healthcare Collaborative™ today announce that Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, will be evaluated in a new study arm of the ongoing I-SPY 2 clinical trial. The I-SPY 2 TRIAL evaluates neoadjuvant treatments for locally advanced breast cancer and is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. Approximately 20 patients will be treated with (Z)-endoxifen for up to 24 weeks prior to surgery.

The new study arm evaluating (Z)-endoxifen is part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), which targets patients with newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. These patients have substantial risk for recurrence, often after five years, and need novel agents that are more tolerable and effective than the current standard of care and address the risk of recurrence.

“Atossa is proud to partner with Quantum Leap Healthcare Collaborative and excited that (Z)-endoxifen has been added to their unprecedented I-SPY clinical trial, which is designed to quickly and efficiently bring new drug therapies to breast cancer patients who need them urgently,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Data from this trial will supplement data generated through our ongoing Phase 2 EVANGELINE trial, which is investigating (Z)-endoxifen as a neoadjuvant treatment for premenopausal women with ER+ / HER2- breast cancer. There remains a critical need for more effective and tolerable treatment options for this patient population.”

“(Z)-endoxifen is one of the most active metabolites of tamoxifen. Tamoxifen is known to be effective in treating and preventing ER+ breast cancer, but may be most effective in those patients who can adequately metabolize it,” said Dr. Laura Esserman of the University of California San Francisco, founder and leader of the I-SPY TRIAL. “(Z)-endoxifen may overcome some of the shortcomings of tamoxifen, as it is already the active metabolite. Perhaps most exciting is that it may be effective in premenopausal women without the need for ovarian suppression. Ovarian suppression in premenopausal women and aromatase inhibitors in postmenopausal women are associated with both short-term and potential long-term side effects that diminish adherence. (Z)-endoxifen holds promise of being a more effective and tolerable alternative to targeting the estrogen receptor in women with early-stage breast cancer.”

Atossa is currently evaluating (Z)-endoxifen in two ongoing Phase 2 studies:

The EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) trial is a randomized non-inferiority study of (Z)-endoxifen compared to exemestane plus goserelin as a neoadjuvant treatment for premenopausal women with Grade 1 or 2 ER+ / HER2- breast cancer. Participants receive neoadjuvant treatment for up to six months, followed by surgery. The primary objective of the EVANGELINE study is to determine whether the endocrine sensitive disease (ESD) rate, measured by Ki-67 (a proliferation marker prognostic for disease free survival), after four weeks of treatment with (Z)-endoxifen is non-inferior to the ESD rate following treatment with current standard of care, exemestane plus goserelin. Exemestane is an aromatase inhibitor designed to block the synthesis of estrogen and slow the growth of ER+ cancers. Goserelin is a medication given to block the ovaries from making estrogen, which in premenopausal women is associated with significant morbidity and inadequate compliance, which compromises efficacy and increases the risk of mortality.

The Karisma-Endoxifen trial is a randomized, double-blind, placebo-controlled efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density. Participants receive daily doses of (Z)-endoxifen for six months, over the course of which mammograms are conducted to measure reduction in mammographic breast density (MBD). Participants also have a mammogram at 24 months to assess the durability of the MBD changes. MBD affects more than 10 million women in the United States and many millions more worldwide. Increased MBD reduces the ability of mammograms to detect cancer. Studies have also shown that women with MBD have an increased risk of developing breast cancer and that the higher the MBD, the higher the incidence of breast cancer.

Atossa will supply (Z)-endoxifen and provide financial support to Quantum Leap for this study. Quantum Leap, as sponsor, will provide the clinical sites and clinical expertise. Currently, there are 41 open sites, all of which have the EOP program open.

About Premenopausal Patients with ER+ / HER2- Breast Cancer
Breast cancer is the most frequently diagnosed cancer in premenopausal women worldwide and accounts for almost half of the cancers that occur in women aged 15-49. 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 stage 2 and 3 premenopausal ER+/HER2- breast cancer. The I SPY Endocrine Optimization Pilot (EOP) specifically targets women of all ages with molecularly low risk stage 2 and 3 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 potent 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 converts a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. 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 are currently studying our (Z)-endoxifen in healthy women with measurable breast density and premenopausal women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by two issued U.S. patents and numerous pending patent applications.

About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing 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

About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate care and research, and to foster high-impact trials with embedded clinical processes and systems technology and improved data management, greater access to clinical trial matching, and greater benefit to patients, providers, and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit https://www.quantumleaphealth.org/

About the I-SPY TRIALs
The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The Endocrine Optimization Pilot (EOP) is developing better endpoints and new endocrine targeted agents for stage 2/3 molecularly low risk breast cancer. The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 30 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org.

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

Eric Van Zanten
VP, Investor and Public Relations
610-529-6219
eric.vanzanten@atossainc.com

Quantum Leap Healthcare Collaborative Media Contact:
Jacqueline Murray
Director, Marketing and Communications
(415) 839-8082
j.murray@quantumleaphealth.org

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 (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.

SEATTLE, March 15, 2023 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in cancer, today announced that the Company will present at the Sidoti Small-Cap Virtual Conference being held March 22-23, 2023. The presentation by Dr. Steven Quay, President and Chief Executive Officer and Kyle Guse, General Counsel and Chief Financial Officer, will take place on Thursday, March 23 at 1:00 pm eastern time.

To register and view a live webcast of the presentation, please visit the event’s website at: https://sidoti.zoom.us/webinar/register/WN_Eeu2shzgQoOEjAkhs9zcng

Following the conference, a recording of the webcast will be made available on the investor relations page of Atossa’s website: https://atossatherapeutics.com/investors

ABOUT ATOSSA THERAPEUTICS
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing 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

CONTACTS:
Kyle Guse
General Counsel and Chief Financial Officer
kyle.guse@atossainc.com

Eric Van Zanten
VP, Investor and Public Relations
610-529-6219
eric.vanzanten@atossainc.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 (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.

SEATTLE, Feb. 23, 2023 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet need in cancer, today announces that the first patient has been dosed in the Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study. EVANGELINE is a randomized non-inferiority trial of Atossa’s patented Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, and exemestane plus goserelin as a neoadjuvant treatment for pre-menopausal women with Grade 1 or 2 Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. Participants will receive neoadjuvant treatment for up to six months, followed by surgery. The study is expected to enroll approximately 175 patients at up to 25 sites across the United States.

The primary objective of the EVANGELINE study is to evaluate the endocrine sensitive disease (ESD) rate, measured by Ki-67 (a proliferation marker prognostic for disease free survival), after four weeks of treatment with (Z)-endoxifen compared to treatment with current standard of care, exemestane plus goserelin. Exemestane is an aromatase inhibitor designed to block the synthesis of estrogen and slow the growth of ER+ cancers. Goserelin is a medication given to block the ovaries from making estrogen, also called ovarian function suppression (OFS). In premenopausal women, OFS is associated with significant morbidity and inadequate compliance, which compromises efficacy and increases the risk of mortality.

(Z)-endoxifen is the most active anti-estrogen metabolite of tamoxifen that potently blocks ERa and binds to and disrupts protein kinase C beta one function (PKCb1, a known oncogenic protein). In an earlier Phase 2 study, treatment with (Z)-endoxifen resulted in a 65.1% reduction in Ki-67. This is potentially clinically meaningful because numerous studies by other groups have shown that reducing Ki-67 is prognostic for 5-year disease free survival. (Z)-endoxifen administered as monotherapy may also obviate the need for OFS in premenopausal women and potentially reduce breast cancer cell proliferation.

“We are excited to kick-off this important trial, a significant achievement in our development strategy,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “Approximately 78% of breast cancers are ER+ / HER2- and premenopausal women diagnosed with this disease need more effective and tolerable treatment options; specifically new treatments that do not require ovarian function suppression. We feel (Z)-endoxifen has the potential to change the treatment paradigm for these patients.”

Atossa is also developing its proprietary (Z)-endoxifen to reduce breast density, a known risk factor for developing breast cancer. The Company has an ongoing Phase 2 trial focused on reducing mammographic breast density (MBD) in healthy, premenopausal women. Known as the “Karisma-Endoxifen” study, this randomized, double-blind, placebo-controlled trial plans to enroll 240 study participants. Participants receive daily doses of (Z)-endoxifen for six months, over the course of which mammograms are conducted to measure reduction in MBD. Participants also have a mammogram at 24 months to assess the durability of the MBD changes.

MBD affects more than 10 million women in the United States and many millions more worldwide. Increased MBD reduces the ability of mammograms to detect cancer. Studies have also shown that women with MBD have an increased risk of developing breast cancer and that the higher the MBD, the higher the incidence of 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 potent 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 converts a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. 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 are currently studying our (Z)-endoxifen in healthy women with measurable breast density and premenopausal women with ER+/HER2- breast cancer.

Atossa’s (Z)-endoxifen is protected by two issued U.S. patents and numerous pending patent applications.

ABOUT ATOSSA THERAPEUTICS
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing 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

CONTACTS:
Kyle Guse
General Counsel and Chief Financial Officer
kyle.guse@atossainc.com

Eric Van Zanten
VP, Investor and Public Relations
610-529-6219
eric.vanzanten@atossainc.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 (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.

SEATTLE, Feb. 13, 2023 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet need in cancer, today announces that the United States Patent and Trademark Office (USPTO) has granted a new patent (No. 11,572,334) directed to (Z)-endoxifen encapsulated in an enteric capsule. This patent further reinforces Atossa’s broad Intellectual Property portfolio related to (Z)-endoxifen. A short ‘explainer’ video about the new patent can be found here: Patent Update – Video Explainer.

Enteric capsules have an acid resistant coating to prevent them from dissolving when they pass through the stomach. Enteric capsules are dissolved when they pass through an alkaline environment, which is usually when they reach the small intestine. Delivering oral (Z)-endoxifen via an enteric capsule prevents breakdown of the endoxifen in the stomach.

“We are very pleased with the scope and breadth of this new key patent,” said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. “It ensures that in the U.S., Atossa will have the only (Z)-endoxifen treatment delivered orally with an enteric capsule, which we believe is the optimal way to deliver the drug. This new patent, further strengthens our intellectual property estate and should create long-term stockholder value.”

Atossa is developing its proprietary (Z)-endoxifen in both the breast cancer treatment and prevention settings. Phase 2 trials are ongoing with the goal of changing the treatment paradigm for patients who are not benefiting from currently approved drugs and helping reduce the incidence of breast cancer.

• Phase 2 “EVANGELINE” study – (Z)-endoxifen and exemestane + goserelin as neoadjuvant treatment in premenopausal women with ER+/HER2- breast cancer. The EVANGELINE trial is expected to enroll approximately 175 patients at up to 25 sites across the United States and builds on an earlier Phase 2 study that showed treatment with (Z)-endoxifen reduced Ki-67, a commonly used measure of cellular proliferation and growth in breast cancer tissue. The EVANGELINE trial will evaluate safety and tolerability of treatment with (Z)-endoxifen, reduction in Ki-67 and pathological response. It will also study whether treatment with (Z)-endoxifen in premenopausal women could provide clinical benefit without the need for ovarian suppression.

• Phase 2 “Karisma-Endoxifen” study – (Z)-endoxifen in premenopausal women with elevated mammographic breast density (MBD). This randomized, double-blind, placebo-controlled trial of healthy, pre-menopausal women with increased breast density is expected to enroll 240 study participants. The treatment cohort receives daily doses of (Z)-endoxifen for six months, over the course of which mammograms will be conducted to measure reduction in MBD. Patients will also be given a mammogram at 24 months to assess the durability of the MBD changes.

Both trials seek to address significant unmet medical need in breast cancer. While there are several FDA-approved neoadjuvant therapies for ER- breast cancers, few good options exist for ER+ patients, which account for approximately 78% of breast cancers. Current treatment approaches for premenopausal women diagnosed with ER+ breast cancer include ovarian suppression, which can induce menopause and dramatically impact a patient’s quality of life. Additionally, MBD affects more than 10 million women in the United States and many millions more worldwide. Increased MBD reduces the ability of mammograms to detect cancer. Studies have also shown that women with MBD have an increased risk of developing breast cancer and that the higher the MBD, the higher the incidence of breast cancer.

“There are a number of research-level medical applications of endoxifen outside of breast cancer, including in bipolar disorder disease in adults and in modulating genetically modified, cell-based therapies for cancer and immune diseases, that may require access to our endoxifen patents and technologies,” continued Dr. Quay. “Atossa will monitor these activities carefully as they approach commercialization, with an eye to establishing appropriate licensing arrangements for the benefit of Atossa shareholders.”

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 converts a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. 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.

ABOUT ATOSSA THERAPEUTICS
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing 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

CONTACTS:
Kyle Guse
General Counsel and Chief Financial Officer
kyle.guse@atossainc.com

Eric Van Zanten
VP, Investor and Public Relations
610-529-6219
eric.vanzanten@atossainc.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.

SEATTLE, Jan. 25, 2023 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet need in cancer, today announces the issuance of the following Letter to Shareholders from Steven C. Quay, M.D., Ph.D., the Company’s CEO and Chairman:

TO OUR VALUED STOCKHOLDERS:

2022 was a year of significant progress for Atossa. We focused our development efforts on advancing our breast cancer program with our patented (Z)-endoxifen, the highest potency Selective Estrogen Receptor Modifier (SERM). We currently have Phase 2 studies ongoing in the prevention and treatment settings, both focused on areas of unmet medical need. Our goal is to both help reduce the incidence of breast cancer and change the treatment paradigm for patients who are not benefiting from currently approved drugs.

In October 2022, the U.S. Food and Drug Administration (FDA) authorized the initiation of our EVANGELINE study, a Phase 2 trial of (Z)-endoxifen and Exemestane + Goserelin as neoadjuvant treatment in premenopausal women with ER+/HER2- breast cancer. While there are several FDA-approved neoadjuvant therapies for ER- breast cancers, few exist for the ER+ patients, which account for approximately 78% of breast cancers. We expect to enroll approximately 175 patients at up to 25 sites across the United States.

The EVANGELINE study marks the first time our proprietary (Z)-endoxifen is being investigated in the United States and builds on the Phase 2 “window of opportunity” study we conducted in Australia. In that study we showed treatment with (Z)-endoxifen reduced Ki-67, a commonly used measure of cellular proliferation and growth in breast cancer tissue, from an average of 25.6% at screening to 6% on the day of surgery, a 65.1% reduction. This is clinically meaningful because numerous studies by other groups have shown a reduction in Ki-67 below 25% improves long term survival for ER+ breast cancer patients.

The EVANGELINE study will help us better understand what happens to tumors when patients are treated with (Z)-endoxifen. For example, is there a pathological response or tumor shrinkage? Even a partial response in the neoadjuvant setting could change the primary treatment approach and potentially save patients from undergoing a radical mastectomy or systemic therapies including chemotherapy, hormonal therapy, and/or targeted therapy.

We are also testing the hypothesis that treatment with (Z)-endoxifen could provide clinical benefit without the need for ovarian suppression. Current treatment approaches for premenopausal women diagnosed with ER+ breast cancer include using drug therapy or surgery to prevent the ovaries from making estrogen. ER+ tumors need estrogen to grow, so lowering hormone levels can restrict growth. However, patients also experience menopausal symptoms, and in some cases, treatment induces natural menopause, which can dramatically impact a patient’s quality of life. There is a critical need for new treatment approaches that provide clinical benefit without ovarian suppression.

We also continue to enroll patients in our Phase 2 study investigating (Z)-endoxifen in premenopausal women with elevated mammographic breast density (MBD). We announced last fall that the study was approximately 40% enrolled which, assuming enrollment continues at the current pace, means we should enroll all 240 study participants by the end of this year.

MBD is an emerging public health issue affecting more than 10 million women in the United States and many millions more worldwide. It’s well understood that increased MBD reduces the ability of mammograms to detect cancer, but studies have also shown that women with MBD have an increased risk of developing breast cancer and that the higher the MBD, the higher the incidence of breast cancer. Importantly, we also know that reducing MBD can lead to a reduction in the incidence of breast cancer.

Our MBD study, known as the Karisma-Endoxifen study, is a randomized, double-blind, placebo-controlled trial of healthy, pre-menopausal women with increased breast density. The treatment cohort receives daily doses of (Z)-endoxifen for six months, over the course of which mammograms will be conducted to measure reduction in MBD. Patients will also be given a mammogram at 24 months to assess the durability of the MBD changes. We believe (Z)-endoxifen may provide an option for women to proactively reduce the density of their breasts, which could improve mammography accuracy and patient care by unmasking cancerous tumors that are otherwise hidden by breast density.

Given the importance of (Z)-endoxifen to the future of Atossa, and the significant impact it could have on the prevention and treatment of breast cancer, it’s critical that we protect the intellectual property covering our proprietary formulation of the drug. Our position was further strengthened in March of last year when the U.S. Patent and Trademark office issued U.S. Patent No. 11,261,151 (the ‘151 Patent). Titled “Methods for Making and Using Endoxifen,” the ‘151 Patent is directed to compositions of storage-stable (Z)-endoxifen and methods of treating hormone-dependent breast disorders using the storage-stable (Z)-endoxifen. The ‘151 Patent is estimated to expire in 2038.

Another important development in 2022 was our investment in Dynamic Cell Therapies, Inc. (DCT), a privately held, venture capital backed developer of CAR-T therapies. 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. While their initial focus is hematologic malignancies, their innovative approach could also have broad applicability in solid tumors and autoimmune diseases. Our investment, which totaled $4.7 million and resulted in Atossa owning approximately 19% of the outstanding capital stock of DCT, closed in December 2022.

Last year we also made the decision to discontinue our COVID-19 programs due to the rapidly shifting treatment landscape and the introduction of effective vaccines, which greatly reduced hospitalizations. Aligned with our sharpened focus on oncology, we expect to revisit the development of AT-H201 as an inhalation therapy for cancer patients with compromised lung-function resulting from radiation treatment in the future. This indication may fill a compelling unmet medical need because radiation-induced lung injury, which can limit the overall success of lung cancer treatment, is often irreversible and poorly treated with current therapies.

As we look forward to 2023, we are well positioned to continue accelerating the development of (Z)-endoxifen. Both of our Phase 2 trials are ongoing, and we will provide enrollment and other updates as developments warrant throughout the year. We also have a strong balance sheet with no debt and cash, cash equivalents and restricted cash of approximately $117 million as of September 30, 2022.

On behalf of the board of directors, management, and employees of Atossa Therapeutics, we thank you for your investment and continued support of our Company.

Sincerely,

Steven C. Quay, M.D., Ph.D.
Chairman of the Board of Directors and Chief Executive Officer

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

SEATTLE, Dec. 07, 2022 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology, is pleased to announce the appointment of Eric Van Zanten as Vice President of Investor and Public Relations. Mr. Van Zanten brings over 25 years of corporate communications experience working within the biopharmaceutical, finance, and healthcare industries. He will oversee corporate, executive, and digital communications, investor relations, thought leadership, and branding for the Company.

“We are excited to welcome Eric to Atossa as we sharpen our focus on developing new therapies for cancer patients,” said Steven Quay, M.D., Ph.D., President and Chief Executive Officer of Atossa. “His extensive industry experience and oncology background make him particularly well-suited to help us share the Atossa story with investors, researchers, media, industry partners and other stakeholders.”

Prior to joining Atossa, Mr. Van Zanten led corporate affairs at Faron Pharmaceuticals, a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers via precision macrophage immunotherapy and Urogen Pharma, a commercial stage biotech delivering innovative solutions that treat specialty cancers. He was also formerly Head of Commercial and Medical Communications and Director of Oncology Communications at Bristol-Myers Squibb where he helped launch Opdivo, one of the most successful oncology brands ever. Earlier in his career he held communications leadership roles at Deloitte, Booz Allen & Hamilton, Children’s Hospital of Philadelphia and Unisys Corporation.

“I am inspired by Atossa’s mission, energized by its entrepreneurial spirit, and impressed by the level of talent it has amassed. I look forward to helping grow and position the Company as we change the way cancer and other diseases are treated,” added Mr. Van Zanten.

Mr. Van Zanten is a graduate of Franklin and Marshall College, where he received his BA in Political Science and Government.

About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing 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

Contacts:
Kyle Guse
General Counsel and Chief Financial Officer
kyle.guse@atossainc.com

Eric Van Zanten
VP, Investor and Public Relations
610-529-6219
eric.vanzanten@atossainc.com

SEATTLE, Nov. 01, 2022 (GLOBE NEWSWIRE) — 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