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Atossa Therapeutics Names Janet R. Rea, MSPH, as Senior Vice President, R&D to Accelerate (Z)-Endoxifen Toward Key Regulatory Milestones

MWN-AI** Summary

Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company focused on innovative breast cancer treatment, has appointed Janet R. Rea, MSPH, as its Senior Vice President of Research and Development. This key strategic hire comes as the company accelerates its (Z)-endoxifen program toward important regulatory milestones, such as upcoming FDA submissions and defining commercialization pathways.

Ms. Rea brings over 20 years of experience in clinical development and regulatory strategies, with a notable record of successful regulatory approvals. Previously, she served in leadership roles at various biopharmaceutical companies and has a history of impactful work at Atossa, where she originally directed clinical studies that laid the groundwork for (Z)-endoxifen's development in Australia, the US, and Sweden.

Not only has Ms. Rea worked on getting programs through approval processes, but her vast expertise spans oncology and biopharmaceuticals to viral and cardiovascular diseases. Her strategic insight into aligning clinical and regulatory efforts with commercial goals will be instrumental for Atossa's growth.

Dr. Steven Quay, Atossa’s CEO, emphasized that Ms. Rea’s experience aligns perfectly with the company’s mission of bringing transformative treatments to patients. With Atossa's focus on (Z)-endoxifen, a highly potent selective estrogen receptor modulator (SERM), there is a strong commitment to addressing a wide variety of clinical needs in breast cancer treatment.

Ms. Rea expressed enthusiasm about rejoining Atossa at a pivotal time, highlighting the potential for (Z)-endoxifen to profoundly impact patient outcomes. As Atossa continues to advance its clinical research, the company remains dedicated to delivering innovative solutions for breast cancer, enhancing both patient care and shareholder value.

MWN-AI** Analysis

The appointment of Janet R. Rea as Senior Vice President of R&D at Atossa Therapeutics is a strategic move that investors should carefully consider. Ms. Rea brings over two decades of regulatory and clinical development experience, making her adept at navigating the complexities of the biopharmaceutical landscape, particularly in oncology. Her track record includes securing regulatory approvals, which is critical for Atossa's lead product candidate, (Z)-endoxifen.

(Z)-endoxifen serves a crucial role in Atossa's pipeline aimed at addressing breast cancer treatment and prevention. The upcoming regulatory submissions and Ms. Rea's established connections within the healthcare ecosystem present an optimistic outlook for the company's progress toward potential commercialization. With a significant unmet clinical need for effective breast cancer therapies, Atossa is positioned favorably to engage with healthcare providers and patients once FDA approvals are achieved.

Investors should also note the broader market dynamics surrounding breast cancer therapeutics. Given the disease's high prevalence, there is a strong demand for innovative treatments, which increases the likelihood of investor interest and market engagement. Atossa's focus on a multifaceted clinical approach with (Z)-endoxifen, designed for various treatment settings, further enhances its value proposition.

Moreover, Ms. Rea's past leadership at Atossa and her history of successful clinical programs could provide much-needed momentum as the company advances its clinical trials. This insider knowledge may also lead to optimized strategies in operational execution and regulatory pathways, potentially resulting in faster turnaround times for clinical milestones.

In summary, Atossa Therapeutics’ prospects appear promising with Rea at the helm of R&D. Investors should monitor the company's progression closely, particularly as it approaches key regulatory milestones with (Z)-endoxifen. The strategic alignment of leadership experience and product potential positions Atossa well for growth in a lucrative and essential market.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: PR Newswire

Atossa Therapeutics Names Janet R. Rea, MSPH, as Senior Vice President, R&D to Accelerate (Z)-Endoxifen Toward Key Regulatory Milestones

PR Newswire

Veteran development leader with successful regulatory approvals record returns to lead late-stage clinical and regulatory programs to address multiple unmet clinical needs

SEATTLE , Oct. 1, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS; "Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, announces the appointment of Janet R. Rea , MSPH to its newly created position Senior Vice President, R&D.  Ms. Rea brings more than two decades of strategic research and clinical development expertise, with a success record for regulatory approvals, to oversee late-stage (Z)-endoxifen programs with near term priorities that include upcoming FDA submissions, interactions, and defining pathway to commercialization.  Atossa Therapeutics is a clinical-stage biopharmaceutical company developing (Z)-endoxifen for innovative therapeutic applications.

Ms. Rea most recently served as a consultant to a variety of biopharmaceutical companies.  She has held senior development leadership roles for AVM Biotechnology (COO, SVP), Atossa Therapeutics , TPI Therapeutics, and Protein Sciences (now Glaxo), where she played a key role leading to the approval of FluBlok ® , an innovative rDNA egg-free influenza vaccine.  She was also an Assistant Professor at the University of Washington , Department of Pharmacy. Prior to that, she secured IND clearance for what is now Exondys 51 (eteplirsen) on behalf of AVI Biopharma (Sarepta). Having previously served as Senior Vice President, Regulatory, Quality, and Clinical Affairs at Atossa, she secured regulatory clearance for and executed clinical studies of (Z)-endoxifen in Australia , the US, and Sweden , which have been the cornerstone of the breast cancer treatment programs. Ms. Rea now returns to Atossa to focus on further advancing Atossa's pipeline, contributing to the development and delivery of new treatments.

"Janet's extensive experience in strategic regulatory and clinical development pathways, particularly in getting programs successfully through approval processes, aligns perfectly with our mission to bring transformative treatments," said Dr. Steven Quay , Atossa Therapeutics Chief Executive Officer. "We are laser-focused on bringing our lead product candidate, (Z)-endoxifen, to market to address the large clinical need across multiple indications. Janet combines approval-path experience with hands-on execution – exactly what we need to propel our programs forward."

For over 20 years, Ms. Rea has built an impressive career with leadership positions in the clinical development and execution of regulatory strategies. She has directed cross-functional teams, led regulatory submissions in the US and internationally, and managed comprehensive clinical development programs including in oncology, biopharmaceuticals, as well as viral and cardiovascular diseases.  Her expertise in aligning clinical strategy with regulatory and commercial goals are supportive to Atossa's growth.

"Atossa is at an exciting inflection point.  I am thrilled to rejoin the team advancing promising (Z)-endoxifen therapies to market," said Ms. Rea.

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/D designed for use across the breast cancer spectrum, including risk-reduction, and treatment in the 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 atossatherapeutics.com .

SOURCE Atossa Therapeutics Inc

FAQ**

How will Janet R. Rea's experience in securing regulatory approvals, particularly with her work at Atossa Therapeutics Inc. ATOS and other biopharmaceutical companies, influence the development timeline of (Z)-endoxifen?

Janet R. Rea's extensive experience in securing regulatory approvals at Atossa Therapeutics Inc. and other biopharmaceutical firms is likely to streamline the development timeline of (Z)-endoxifen by enhancing compliance and facilitating efficient interactions with regulatory agencies.

What are the key regulatory milestones Atossa Therapeutics Inc. ATOS aims to achieve under Janet R. Rea's leadership as they advance (Z)-endoxifen towards commercialization?

Under Janet R. Rea's leadership, Atossa Therapeutics Inc. aims to achieve key regulatory milestones such as filing for Investigational New Drug (IND) applications, progressing through clinical trial phases, and ultimately securing FDA approval for (Z)-endoxifen.

Given Janet R. Rea's previous success with various clinical programs, what specific strategies does Atossa Therapeutics Inc. ATOS plan to implement to address the unmet clinical needs associated with breast cancer treatment?

Atossa Therapeutics Inc. plans to leverage Janet R. Rea's expertise by focusing on innovative clinical trial designs, enhancing patient recruitment strategies, and targeting novel therapeutic pathways to address specific unmet clinical needs in breast cancer treatment.

How does Atossa Therapeutics Inc. ATOS envision the role of (Z)-endoxifen evolving within the current breast cancer treatment landscape as Janet R. Rea takes the lead in R&D?

Atossa Therapeutics Inc. envisions (Z)-endoxifen playing a pivotal role in breast cancer treatment by potentially offering a novel therapeutic option under Janet R. Rea's leadership, aimed at improving outcomes for patients who may not respond to traditional therapies.

**MWN-AI FAQ is based on asking OpenAI questions about Atossa Therapeutics Inc. (NASDAQ: ATOS).

Atossa Therapeutics Inc.

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