Core Viewpoint - Atossa Therapeutics supports the U.S. Surgeon General's Advisory linking alcohol consumption to increased breast cancer risk, emphasizing the need for public awareness and proactive measures to reduce alcohol-related cancer cases [1][3]. Summary by Relevant Sections Alcohol Consumption and Cancer Risk - Alcohol consumption is responsible for nearly 100,000 cancer cases and approximately 20,000 cancer deaths annually in the U.S., making it the third leading preventable cause of cancer [2]. - Breast cancer accounts for about 44,180 alcohol-related cases in women each year, representing approximately 16.4% of all breast cancer diagnoses [2]. Company Position and Initiatives - Atossa Therapeutics aligns its mission with the Advisory, advocating for public education on the risks associated with alcohol consumption and breast cancer [3][5]. - The company has released a video to further educate the public about the Advisory and its implications for breast cancer prevention [4]. Recommendations for Public Health - The Advisory calls for updating health warning labels on alcoholic beverages to reflect cancer risks and expanding public education efforts to raise awareness of alcohol's link to breast cancer [8]. - It highlights alcohol consumption as a leading modifiable cancer risk factor and suggests incorporating proven alcohol reduction strategies into cancer prevention initiatives [8].

Core Insights - Atossa Therapeutics supports the U.S. Surgeon General's Advisory linking alcohol consumption to increased breast cancer risk, emphasizing the need for public awareness and education on this issue [1][3][5] Industry Insights - Alcohol consumption is responsible for nearly 100,000 cancer cases and approximately 20,000 cancer deaths annually in the U.S., making it the third leading preventable cause of cancer after tobacco and obesity [2] - Breast cancer accounts for about 44,180 alcohol-related cases in women each year, representing approximately 16.4% of all breast cancer diagnoses [2] - The Advisory indicates that the risk of breast cancer begins to rise with the consumption of as little as one drink per day, yet only 45% of Americans believe alcohol significantly affects cancer development [3][4] Company Initiatives - Atossa Therapeutics is committed to advancing therapies aimed at reducing breast cancer burden and supports public policies that inform and protect women's health [5] - The company has released a video to further educate the public about the Surgeon General's Advisory and its implications for breast cancer [4] - Atossa advocates for updating health warning labels on alcoholic beverages, expanding public education efforts, and incorporating alcohol reduction strategies into cancer prevention initiatives [8]

Core Insights - Atossa Therapeutics has announced promising results from its Phase 2 KARISMA-Endoxifen trial, indicating that low-dose (Z)-endoxifen may significantly reduce mammographic breast density (MBD) in premenopausal women at risk of breast cancer while maintaining a favorable safety profile [1][4]. Study Design - The trial was a randomized, double-blind, placebo-controlled study involving 240 premenopausal women aged 40-55, who were assigned to receive either a placebo, 1 mg, or 2 mg of daily oral (Z)-endoxifen for six months [2]. Results - The 1 mg dose of (Z)-endoxifen resulted in a reduction of MBD by 17.3 percentage points (p<0.01), while the 2 mg dose achieved a reduction of 23.5 percentage points (p<0.01). In contrast, the placebo group showed a minimal change of 0.27 percentage points [3]. - Plasma concentrations of (Z)-endoxifen were recorded at 4.8 ng/mL for the 1 mg group and 9.7 ng/mL for the 2 mg group, demonstrating the effectiveness of the lower dose [3]. - No significant differences in adverse events were noted between the 1 mg dose and placebo, although the 2 mg dose was associated with higher incidences of hot flashes, night sweats, and vaginal discharge [3]. Implications - The results suggest that (Z)-endoxifen could serve as a preventative therapy for women with dense breast tissue, potentially offering a safer alternative to tamoxifen with fewer side effects [4]. - The findings align with previous studies on tamoxifen, indicating comparable reductions in MBD with lower plasma concentrations and reduced side effects [4]. Presentation Details - The results will be presented during a Poster Spotlight Session at the 2024 San Antonio Breast Cancer Symposium, highlighting the effectiveness of low-dose (Z)-endoxifen in reducing MBD [5]. About (Z)-Endoxifen - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that may cause estrogen receptor degradation and has shown efficacy in patients resistant to other hormonal treatments. It targets PKCβ1, an oncogenic protein, and exhibits favorable bone agonistic effects with minimal endometrial proliferation compared to standard treatments like tamoxifen [6]. Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative medicines for significant unmet medical needs in oncology, particularly in breast cancer prevention and treatment [9].

Drug Development and Clinical Trials - The company is developing oral (Z)-endoxifen for the prevention and treatment of breast cancer, with patent protection extending through at least November 17, 2038[79]. - A Phase 2 study of oral (Z)-endoxifen for women with mammographic breast density (MBD) fully enrolled 240 participants in November 2023, showing reductions of 19.3% and 26.5% in breast density for 1 mg and 2 mg doses, respectively, compared to placebo[80]. - The study on (Z)-endoxifen for MBD demonstrated that it was generally well tolerated, with only 4, 5, and 11 women discontinuing due to side effects in the placebo, 1 mg, and 2 mg arms, respectively[80]. - The company plans to conduct additional studies to assess the correlation between (Z)-endoxifen and the risk of breast cancer, as reduction in MBD may not be an approvable indication without demonstrating a decrease in breast cancer incidence[80]. - The company has completed four Phase 1 and two Phase 2 clinical studies of (Z)-endoxifen, including studies in men and various formulations[80]. - The Phase 2 RECAST study for (Z)-endoxifen is ongoing, with approximately 100 patients being treated to evaluate suitability for long-term active surveillance[1]. - The EVANGELINE study is expected to enroll approximately 180 patients, with the Treatment Cohort initiation anticipated in Q4 2024[1]. - A preliminary analysis from the I-SPY 2 trial showed that 95% of patients received over 75% of planned treatment, with a 69% reduction in Ki-67 after three weeks of (Z)-endoxifen treatment[1]. Financial Performance - Total operating expenses decreased to $6.4 million for the three months ended September 30, 2024, down from $7.5 million in the same period of 2023, representing a decrease of approximately 14.7%[85]. - Research and Development (R&D) expenses totaled $3.4 million for the three months ended September 30, 2024, a decrease of $1.1 million or 24% compared to $4.5 million in the same period of 2023[86]. - Clinical and non-clinical trial expenses decreased by $0.9 million for the three months ended September 30, 2024, primarily due to reduced spending on (Z)-endoxifen trials[87]. - General and Administrative (G&A) expenses totaled $2.973 million for the three months ended September 30, 2024, a slight decrease of 1% from $3.001 million in the same period of 2023[90]. - G&A professional fees increased by $0.3 million for the three months ended September 30, 2024, primarily due to higher legal fees related to patent activity[91]. - The company has no revenue sources and does not anticipate generating revenue until pharmaceutical programs are developed and launched[82]. - For the nine months ended September 30, 2024, the net loss was $19.2 million, with cash used in operating activities amounting to $14.0 million, a decrease of $1.4 million from the same period in 2023[94]. - As of September 30, 2024, the company had $74.8 million in cash and cash equivalents, indicating sufficient funds to cover projected operating requirements for at least the next 12 months[94]. - The estimated non-cancellable commitment for clinical trials as of September 30, 2024, was $10.5 million[96]. - The company recorded an impairment charge on investment in equity securities of $1.7 million for the nine months ended September 30, 2024, compared to $3.0 million for the same period in 2023[93]. - Net cash used in investing activities was $19 thousand for the nine months ended September 30, 2024, primarily related to purchases of computers[94]. - The company expects to incur ongoing operating losses as it continues to develop its therapeutic programs, with future funding requirements dependent on various factors including clinical trial costs[95]. - The company may need to raise additional funds even before they are required if market conditions are favorable[95]. Operational and Strategic Focus - The company aims to advance its programs through clinical studies and opportunistically add programs in areas of high unmet medical need through acquisitions or collaborations[79]. - The company is focused on addressing significant unmet medical needs in oncology, particularly in women's breast cancer and related conditions[79]. - The company is developing clinical manufacturing capabilities through qualified third parties to support its drug development[80]. - The company is subject to various risks, including regulatory approvals and the ability to attract and retain key personnel, which could impact its future performance[77]. - The company has not engaged in off-balance sheet arrangements or trading activities involving non-exchange traded contracts[98]. - The company entered into a new operating lease for office space at $1,000 per month starting June 1, 2024, after terminating a previous lease[82]. - No shares were repurchased under the Share Repurchase Program during the three and nine months ended September 30, 2024, despite the program authorizing up to $10.0 million[97].

Exhibit 99.1 Atossa Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update • Announced positive topline results from KARISMA-Endoxifen Phase 2 study which demonstrated that low doses of (Z)-endoxifen significantly reduced mammographic breast density (MBD), addressing a key breast cancer risk factor • Released a preliminary analysis from I-SPY 2 Endocrine Optimization Pilot (EOP) Phase 2 trial of (Z)- endoxifen which met the primary endpoint with 95 percent (19/20 patients) ...

Announced positive topline results from KARISMA-Endoxifen Phase 2 study which demonstrated that low doses of (Z)-endoxifen significantly reduced mammographic breast density (MBD), addressing a key breast cancer risk factorReleased a preliminary analysis from I-SPY 2 Endocrine Optimization Pilot (EOP) Phase 2 trial of (Z)-endoxifen which met the primary endpoint with 95 percent (19/20 patients) receiving > 75 percent of planned treatmentAnnounced the dosing of the first patient in a clinical trial conducted ...

(Z)-Endoxifen Shown to Significantly Reduce Mammographic Breast Density, Potentially Paving the Way for Innovative Cancer Prevention Strategies SEATTLE, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today released positive topline data from the KARISMA-Endoxifen Phase 2 study of (Z)-endoxifen in premenopausal women with mammographic breast density (MBD). The ...

SEATTLE, Oct. 14, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), today announced that Michael Parks, Vice President, Investor and Public Relations, will participate in a virtual fireside chat on Wednesday, October 16, 2024 at 12:00 p.m. EDT at the 2024 Maxim Healthcare Virtual Summit. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer. Interes ...

SEATTLE, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), today announced its recognition and support of Breast Cancer Awareness Month this October; highlighting the importance of increasing awareness, advancing research, and driving progress toward innovative treatments for breast cancer. Approximately one in eight women will be diagnosed with breast cancer in their lifetime, so this annual campaign serves as a powerful reminder of the ongoing need for ...

For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Is Atossa Genetics Inc. (ATOS) one of those stocks right now? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Atossa Genetics Inc. is one of 1016 companies in the Medical group. The Medical group currently sits at #5 within the Zacks Sector Rank. The Zacks Sector Rank considers 16 differen ...