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SERM Market Shows Promising Growth Trajectory During the Study Period (2020-2034) Owing to the Rising Demand in Oncology and Women's Health
SERM Market Shows Promising Growth Trajectory During the Study Period (2020-2034) Owing to the Rising Demand in Oncology and Women's Health

Malaysian Reserve

time4 days ago

  • Business
  • Malaysian Reserve

SERM Market Shows Promising Growth Trajectory During the Study Period (2020-2034) Owing to the Rising Demand in Oncology and Women's Health

The SERMs market is projected to experience substantial growth in the near future, driven by a rising incidence of cancer diagnoses, growing awareness about SERMs, and a surge in the number of SERMs undergoing clinical trials or awaiting regulatory approval by various companies. LAS VEGAS, July 17, 2025 /PRNewswire/ — DelveInsight's SERM Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as breast cancer, postmenopausal osteoporosis, dyspareunia and vaginal dryness, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging SERM, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM. Key Takeaways from the SERM Market Report As per DelveInsight's analysis, the total market size of SERM in the 7MM is expected to surge significantly by 2034. The report provides the total potential number of patients in the indications, such as breast cancer, postmenopausal osteoporosis, dyspareunia and vaginal dryness, and others. Leading SERM companies, such as Atossa Therapeutics, Sermonix Pharmaceuticals, and others, are developing novel SERMs that can be available in the SERM market in the coming years. Some of the key SERMs in the pipeline include (Z)-Endoxifen, Lasofoxifene, and others. In April 2025, Atossa Therapeutics announced that the US Patent and Trademark Office (USPTO) had granted a new patent (US Patent No. 12,275,684) directed to enteric oral formulations comprising (Z)-Endoxifen as well as methods of treating subjects with those oral formulations. In April 2025, Sermonix Pharmaceuticals and Quantum Leap Healthcare Collaborative broadly announced that in the Phase II clinical trial evaluating lasofoxifene as a neoadjuvant endocrine therapy in molecularly selected HR+/HER2-, locally advanced breast cancer, the investigational drug was well tolerated and demonstrated promising early activity in suppressing the Ki67 protein in both premenopausal and postmenopausal patients. In January 2025, Sermonix Pharmaceuticals announced the publication of an article entitled 'Effects of Lasofoxifene Versus Fulvestrant on Vaginal and Vulvar Symptoms in Patients with ESR1-Mutated, ER+/HER2-, Metastatic Breast Cancer from the ELAINE-1 Study', in the peer-reviewed journal Clinical Breast Cancer. Discover which indication is expected to grab the major SERM market share @ SERM Market Report SERM Market Dynamics The SERM market is witnessing dynamic growth, driven by an increasing prevalence of hormone-related disorders such as breast cancer, osteoporosis, and infertility. SERMs function by selectively stimulating or inhibiting estrogen receptors in different tissues, offering therapeutic benefits without the widespread side effects of hormone replacement therapy. With rising global awareness of women's health issues and increasing access to healthcare in emerging markets, the demand for SERMs is projected to grow steadily. Additionally, advancements in personalized medicine are supporting the use of SERMs in targeted therapies, particularly in oncology and postmenopausal care. A key driver of the SERM market is the high incidence of hormone receptor-positive breast cancer. As oncology treatment paradigms shift toward more targeted, less toxic therapies, SERMs continue to play a critical role in both adjuvant and preventive settings. Moreover, their utility in conditions such as osteoporosis supports their broader adoption in geriatric medicine. However, market growth is tempered by several factors, including the emergence of alternative therapies such as aromatase inhibitors and biologics, which offer improved efficacy in certain indications. Concerns around side effects, such as thromboembolic events and endometrial cancer risk with long-term SERM use, have also led to cautious prescribing practices. Additionally, generic competition has eroded profit margins for several first-generation SERMs, prompting pharmaceutical companies to invest in next-generation compounds with better safety and efficacy profiles. Innovation remains a key aspect of the market dynamics, with ongoing research exploring newer SERMs that can provide tissue-specific actions with reduced adverse effects. These next-generation SERMs aim to expand therapeutic applications beyond traditional indications, including cardiovascular health and cognitive disorders in postmenopausal women. Strategic collaborations, licensing deals, and regulatory approvals are shaping the competitive landscape, with companies focusing on differentiated product offerings and combination therapies. In summary, the SERM market is marked by a strong clinical foundation, expanding therapeutic applications, and evolving competition. As aging populations and hormone-related conditions continue to rise globally, the demand for SERMs is expected to remain robust. Nevertheless, future growth will depend on continued innovation, improved safety profiles, and integration into broader personalized treatment strategies. SERM Treatment Market SERMs are utilized in the treatment of various estrogen-related conditions. These include managing ovulatory dysfunction in infertility, preventing and treating postmenopausal osteoporosis, treating and lowering the risk of breast cancer, and addressing dyspareunia caused by menopause. SERMs are also combined with conjugated estrogens to manage estrogen deficiency and vasomotor symptoms linked to menopause. Their usage is tailored based on their tissue-specific activity. Tamoxifen is a primary hormonal therapy for estrogen receptor (ER)-positive metastatic breast cancer and is also prescribed for reducing breast cancer risk in high-risk women. It serves as an adjuvant therapy in ductal carcinoma in situ with or without axillary node involvement. Additionally, tamoxifen helps improve bone density and lipid profiles in postmenopausal women. Toremifene, a derivative of tamoxifen with chlorine substitution, was developed to reduce liver-related side effects such as DNA adduct formation and potential hepatic tumors. It is used as endocrine therapy in ER/PR-positive stage IV or recurrent metastatic breast cancer and has shown comparable efficacy to tamoxifen in both adjuvant and metastatic settings. OSPHENA (ospemifene), an estrogen receptor agonist/antagonist, is approved for the treatment of moderate to severe dyspareunia and vaginal dryness resulting from vulvovaginal atrophy due to menopause. Initially approved by the US FDA in 2013 and marketed by Shionogi, it later gained EU approval in 2015. In 2017, Duchesnay obtained exclusive marketing rights for OSPHENA in the US and Canada. DUAVEE (marketed as DUAVIVE in the EU) combines conjugated estrogens with a SERM and is indicated for treating moderate to severe vasomotor symptoms of menopause and for preventing postmenopausal osteoporosis. It was approved for use in the US in October 2013 and in the EU in December 2014. Learn more about the SERM @ SERM Analysis Key Emerging SERM and Companies Several key players, including Atossa Therapeutics ((Z)-Endoxifen), Sermonix Pharmaceuticals (Lasofoxifene), and others are involved in developing drugs for SERMs for various indications such as breast cancer, dyspareunia and vaginal dryness, and others. Overall, this is an exciting new class of agents with great potential for development. (Z)-Endoxifen, developed by Atossa Therapeutics, is a nonsteroidal selective estrogen receptor modulator (SERM) from the triphenylethylene class, currently in Phase II development for estrogen receptor-positive (ER+) breast cancer. This agent shows promise across multiple stages of breast cancer management: lowering breast tissue density to reduce cancer risk, decreasing cancer cell activity before surgery, and helping prevent recurrence or new tumors following initial treatment. Atossa is advancing (Z)-Endoxifen with a focus on treating metastatic breast cancer. In April 2025, Atossa announced that the U.S. Patent and Trademark Office granted a new patent (US Patent No. 12,275,684) covering enteric oral formulations of (Z)-Endoxifen and their use in treatment methods. Earlier, in December 2024, the company presented three posters at the San Antonio Breast Cancer Symposium (SABCS), showcasing pharmacokinetic and tolerability findings from the ongoing Phase II EVANGELINE trial. Lasofoxifene is a novel investigational endocrine therapy being studied for its effectiveness as an ESR1 antagonist, particularly in tumors with ESR1 mutations. It has demonstrated notable anti-tumor activity both as a standalone treatment and when used with a CDK4/6 inhibitor in Phase II trials. Lasofoxifene is distinguished by its selective activity in different tissues, with previously observed benefits for vaginal and bone health. In April 2025, Sermonix Pharmaceuticals and Quantum Leap Healthcare Collaborative reported encouraging Phase II data from a neoadjuvant trial of lasofoxifene in patients with HR+/HER2- locally advanced breast cancer, showing good tolerability and early suppression of the proliferation marker Ki67 in both premenopausal and postmenopausal women. Earlier, in January 2025, Sermonix published findings in Clinical Breast Cancer from the ELAINE-1 study, comparing lasofoxifene and fulvestrant, highlighting lasofoxifene's positive effects on vaginal and vulvar symptoms in ESR1-mutated, ER+/HER2- metastatic breast cancer patients. The anticipated launch of these emerging therapies are poised to transform the SERM market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the SERM market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about SERM clinical trials, visit @ SERM Treatment SERM Overview Selective estrogen receptor modulators (SERMs), also referred to as estrogen receptor agonists/antagonists (ERAAs), are a group of compounds that interact with estrogen receptors (ERs). Unlike full agonists or pure antagonists, SERMs exhibit tissue-specific actions, meaning they can either stimulate or block estrogenic effects depending on the target tissue. This selective behavior is due to their ability to bind to the two estrogen receptor subtypes, ERα and ERβ, in ways that influence their activity uniquely across different tissues. The resulting effects are determined by how SERMs modify signaling pathways in a tissue-dependent manner, rather than by directly altering DNA. In the context of bone health, SERMs help regulate bone metabolism by decreasing osteoclast activity via a mechanism involving transforming growth factor-β3, leading to reduced bone resorption and thereby supporting the prevention and treatment of osteoporosis. SERM Epidemiology Segmentation The SERM market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Cases of Selected Indication for SERM Total Eligible Patients of the Selected Indications Total Treated Cases in Selected Indications for SERMs SERM Report Metrics Details Study Period 2020–2034 SERM Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Indications Covered in the Report Breast cancer, Postmenopausal osteoporosis, Dyspareunia and vaginal dryness, and others Key SERM Companies Atossa Therapeutics, Sermonix Pharmaceuticals, Duchesnay, Pfizer, Eli Lilly, and others Key SERM (Z)-Endoxifen, Lasofoxifene, OSPHENA, DUAVEE, EVISTA (raloxifene hydrochloride), FABLYN, and others Scope of the SERM Market Report SERM Therapeutic Assessment: SERM current marketed and emerging therapies SERM Market Dynamics: Conjoint Analysis of Emerging SERM Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, SERM Market Access and Reimbursement Discover more about SERMs in development @ SERM Clinical Trials Table of Contents 1 Key Insights 2 Report Introduction 3 Executive Summary of SERM 4 Key Events 5 Market Forecast Methodology 6 SERM Market Overview at a Glance in the 7MM 6.1 Market Share (%) Distribution by Indication in 2024 6.2 Market Share (%) Distribution by Indication in 2034 7 SERM: Background and Overview 8 Treatment and Management 9 Target Patient Pool 9.1 Key Findings 9.2 Assumptions and Rationale: 7MM 9.3 Epidemiology Scenario in the 7MM 9.3.1 Total Cases of Selected Indication for SERM in the 7MM 9.3.2 Total Eligible Patient Pool for SERM in Selected Indication in the 7MM 9.3.3 Total Treatable Cases in Selected Indication for SERM in the 7MM 10 Marketed Therapies 10.1 Key Competitors 10.2 OSPHENA (ospemifene): Duchesnay 10.2.1 Product Description 10.2.2 Regulatory milestones 10.2.3 Other developmental activities 10.2.4 Clinical development 10.2.5 Safety and efficacy 10.3 DUAVEE (conjugated estrogens/bazedoxifene): Pfizer 10.3.1 Product Description 10.3.2 Regulatory milestones 10.3.3 Other developmental activities 10.3.4 Clinical development 10.3.5 Safety and efficacy List to be continued in the report… 11 Emerging Therapies 11.1 Key Competitors 11.2 (Z)-Endoxifen: Atossa Therapeutics 11.2.1 Product Description 11.2.2 Other developmental activities 11.2.3 Clinical development 11.2.4 Safety and efficacy 11.3 Lasofoxifene: Sermonix Pharmaceuticals 11.3.1 Product Description 11.3.2 Other developmental activities 11.3.3 Clinical development 11.3.4 Safety and efficacy List to be continued in the report… 12 SERM: Seven Major Market Analysis 12.1 Key Findings 12.2 Market Outlook 12.3 Conjoint Analysis 12.4 Key Market Forecast Assumptions 12.4.1 Cost Assumptions and Rebates 12.4.2 Pricing Trends 12.4.3 Analogue Assessment 12.4.4 Launch Year and Therapy Uptakes 12.5 Total Market Size of SERM in the 7MM 12.6 The United States 12.7 EU4 and the UK 12.8 Japan 13 SWOT Analysis of SERM 14 KOL Views of SERM 15 Unmet Needs of SERM 16 Market Access and Reimbursement 17 Bibliography 18 Report Methodology Related Reports Metastatic HR+/HER2− Breast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HR+/HER2− breast cancer companies, including Merck, Arvinas, Olema Pharmaceuticals, Celcuity, Roche, AstraZeneca, Daiichi Sankyo, Eli Lilly, Sermonix Pharmaceuticals, Genentech, Veru Pharma, DualityBio, BioNtech, Evgen Pharma, Carrick Therapeutics, EQRx, G1 Therapeutics, Immutep, among others. Metastatic HER2-positive Breast Cancer Market Metastatic HER2-positive Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic HER2-positive breast cancer companies, including Byondis, Tanvex Biopharma, Prestige BioPharma, EirGenix, AMbrx, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Roche, Jiangsu Alphamab Oncology Co., Ltd., Jiangsu HengRui Medicine Co., Ltd., RemeGen, Shanghai Henlius Biotech, Merus N.V., Hangzhou DAC Biotech, Lepu Biopharma, Zymeworks, Klus Pharma Inc., Bolt Biotherapeutics, GeneQuantum Healthcare, ALX Oncology, Precirix, BriaCell Therapeutics Corporation, Bliss Biopharmaceutical, BioInvent International, Incyte Corporation, Triumvira Immunologics, Inc., Horizon Therapeutics, among others. Breast Cancer Market Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key breast cancer companies, including Veru, Sanofi, Roche, AstraZeneca, Eli Lilly, EQRx, Gilead, Sermonix Pharmaceuticals, Evgen Pharma, Tyme, Genentech, Daiichi Sankyo, among others. Postmenopausal Osteoporosis Market Postmenopausal Osteoporosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key postmenopausal osteoporosis companies, including Suzhou Suncadia Biopharmaceuticals, Shanghai Henlius Biotech, Inc., Mabpharm Limited, Alvotech, Samsung Bioepis Co., Ltd., Biocon Biologics, Entera Bio Ltd., Genor Biopharma Co., Ltd., Addpharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakurinfo@ +14699457679 Logo: View original content:

Ascendiant Lifts Atossa Therapeutics, Inc. (ATOS) Target Citing Strong Liquidity
Ascendiant Lifts Atossa Therapeutics, Inc. (ATOS) Target Citing Strong Liquidity

Yahoo

time04-07-2025

  • Business
  • Yahoo

Ascendiant Lifts Atossa Therapeutics, Inc. (ATOS) Target Citing Strong Liquidity

Atossa Therapeutics, Inc. (NASDAQ:ATOS) is among the best growth stocks to invest in for the next 5 years. Ascendiant Capital analysts slightly increased the price target for Atossa Therapeutics, Inc. (NASDAQ:ATOS) to $7.50, up from $7.25, with an unchanged Buy rating. This potential surge of 837% from current levels reinforces the company's attractive valuation. In making their judgment, the analysts noted that the updated price target is the perfect balance between the company's high risks and its growth prospects. While analyzing the net present value of Atossa Therapeutics, Inc. (NASDAQ:ATOS), the firm pointed towards the company's impressive liquidity position with a current ratio of 12.67. This is anything but ordinary. A scientist in a laboratory, working on developing a new cancer therapy. Despite its associated risks, Atossa Therapeutics, Inc. (NASDAQ:ATOS) exhibits high upside opportunities. Just recently, the company highlighted its strategic moves in breast cancer at the Jefferies Conference. While utilizing Generative AI, Atossa Therapeutics will discover effective drug combinations, along with efforts to capitalize on the multi-billion-dollar market for estrogen receptor-positive breast cancer with Z endoxifen. Atossa Therapeutics, Inc. (NASDAQ:ATOS) is a Washington-based clinical-stage biopharmaceutical company focused on developing medicines for women's breast cancer and other oncological conditions. Founded in 2008, the company aims to transform breast cancer treatment through innovative and tailored solutions. While we acknowledge the potential of ATOS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Sign in to access your portfolio

Ascendiant Reaffirms Their Buy Rating on Atossa Therapeutics (ATOS)
Ascendiant Reaffirms Their Buy Rating on Atossa Therapeutics (ATOS)

Business Insider

time06-06-2025

  • Business
  • Business Insider

Ascendiant Reaffirms Their Buy Rating on Atossa Therapeutics (ATOS)

In a report released today, Edward Woo from Ascendiant maintained a Buy rating on Atossa Therapeutics (ATOS – Research Report), with a price target of $7.50. The company's shares opened today at $0.87. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Woo covers the Healthcare sector, focusing on stocks such as GRI Bio, Envoy Medical, and Cingulate Inc. According to TipRanks, Woo has an average return of -8.2% and a 34.36% success rate on recommended stocks. The word on The Street in general, suggests a Strong Buy analyst consensus rating for Atossa Therapeutics with a $5.56 average price target, a 539.08% upside from current levels. In a report released today, Craig-Hallum also initiated coverage with a Buy rating on the stock with a $4.00 price target.

Atossa Therapeutics to Present at the Jefferies Global Healthcare Conference
Atossa Therapeutics to Present at the Jefferies Global Healthcare Conference

Yahoo

time02-06-2025

  • Business
  • Yahoo

Atossa Therapeutics to Present at the Jefferies Global Healthcare Conference

SEATTLE, June 2, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced that Dr. Steven Quay, M.D., Ph.D., President and Chief Executive Officer, will present at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025 at 7:35 a.m. Eastern Time. A live webcast of the presentation can be accessed on the Investors section of the Atossa website under "Events and Presentations" at The webcast will be archived for 30 days. About Atossa TherapeuticsAtossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The company's lead product candidate, (Z)-endoxifen, is a highly potent SERM designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit View original content to download multimedia: SOURCE Atossa Therapeutics Inc Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Join Atossa Therapeutics' Exclusive Live Investor Webinar and Q&A Session on May 22
Join Atossa Therapeutics' Exclusive Live Investor Webinar and Q&A Session on May 22

Associated Press

time20-05-2025

  • Business
  • Associated Press

Join Atossa Therapeutics' Exclusive Live Investor Webinar and Q&A Session on May 22

SEATTLE, WASHINGTON / ACCESS Newswire / May 20, 2025 / Atossa Therapeutics, Inc. (Nasdaq:ATOS) ('Atossa' or the 'Company'), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, is pleased to invite investors to a webinar on May 22, 2025, at 4:15 p.m. ET. The exclusive event, hosted by RedChip Companies, will feature Dr. Steven Quay, CEO of Atossa Therapeutics. Attendees will gain insight into Atossa's strategic approach to redefining breast cancer treatment through its lead clinical candidate, (Z)-endoxifen - a next-generation SERM with best-in-class potential. With a focus on metastatic breast cancer, where current therapies often fall short, Atossa is advancing multiple Phase 2 studies that demonstrate strong clinical activity, improved tolerability, and a favorable safety profile. The presentation will highlight recent progress across key development programs, upcoming milestones, and how the Company's differentiated science and capital-efficient model are designed to deliver both clinical impact and long-term shareholder value. A live question and answer session will follow the presentation. To register for the free webinar, please visit: Questions can be pre-submitted to [email protected] or online during the live event. About Atossa Therapeutics Atossa Therapeutics, Inc. (Nasdaq:ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The company's lead product candidate, (Z)-endoxifen, is a highly potent SERM designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit FORWARD LOOKING STATEMENTS This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as 'expect,' 'potential,' 'continue,' 'may,' 'will,' 'should,' 'could,' 'would,' 'seek,' 'intend,' 'plan,' 'estimate,' 'anticipate,' 'believe,' 'design,' 'predict,' 'future,' or other comparable words. All statements made in this press release that are not statements of historical fact, including statements regarding data related to the (Z)-endoxifen program, the safety, tolerability and efficacy of (Z)-endoxifen, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval, benefits of the Company's strategy of pursuing a metastatic indication for (Z)-endoxifen, the expected design and enrollment of trials and timing of data and related publications, and the potential market and growth opportunities for the Company, are forward-looking statements. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, to differ materially from those projected or anticipated, including risks and uncertainties associated with: our ability to obtain patent coverage for our product candidates; macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim or preliminary and final clinical results or analysis; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to regain compliance or maintain compliance with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Contact: Michael Parks VP, Investor and Public Relations 484-356-7105 [email protected] Contact: Dave Gentry RedChip Companies, Inc. 1-407-644-4256 [email protected] SOURCE: Atossa Therapeutics, Inc. press release

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