8-K: Atossa Therapeutics Responds to PTAB Ruling and Announces New Patent Issuance

Atossa Therapeutics announces a response to an unfavorable PTAB ruling regarding U.S. Patent No. 11,572,334, while also highlighting the issuance of a new patent, U.S. Patent No. 12,201,591, related to sustained release compositions of endoxifen.

Summary

• Atossa Therapeutics announced the Patent Trial and Appeal Board's (PTAB) final written decision in PGR2023-00043, which found all claims under U.S. Patent No. 11,572,334 unpatentable.
• The company disagrees with the decision but will not appeal due to cost and time considerations.
• Instead, Atossa intends to pursue patent protection around its current formulations in clinical development, including a new Continuation Patent Application.
• Atossa also announced the issuance of U.S. Patent No. 12,201,591, entitled 'Sustained Release Compositions of Endoxifen', with 31 claims, on January 21, 2025.
• The company believes its Continuation Patent Application will help refine patents on (Z)-endoxifen, potentially increasing its commercial value and competitiveness.
• Atossa is developing (Z)-endoxifen as a treatment for breast cancer and is currently studying it in five Phase 2 trials.
• Atossa's (Z)-endoxifen is protected by four issued U.S. patents and numerous pending patent applications.

Sentiment

Score: 5

Explanation: The sentiment is neutral. While the company faced a setback with the PTAB ruling, they are actively pursuing alternative patent strategies and have secured a new patent. The focus remains on clinical development and future patent protection.

Positives

• Atossa received U.S. Patent No. 12,201,591 for 'Sustained Release Compositions of Endoxifen', which includes 31 claims.
• Atossa is focusing on securing further patent protection for its (Z)-endoxifen formulations in clinical development.
• Atossa has four issued U.S. patents protecting (Z)-endoxifen and numerous pending patent applications.
• (Z)-endoxifen is currently being studied in five Phase 2 trials for breast cancer treatment and prevention.

Negatives

• The PTAB ruled U.S. Patent No. 11,572,334 unpatentable.
• Atossa will not appeal the PTAB decision due to cost and time.

Risks

• The company's inability to obtain patent coverage for its product candidates poses a risk.
• Macroeconomic conditions and increasing geopolitical instability could impact the company.
• Variations between interim or preliminary and final clinical results could affect the development of (Z)-endoxifen.
• Actions and inactions by the FDA and foreign regulatory bodies could impact the approval process.
• The company's ability to raise capital and maintain compliance with Nasdaq listing requirements are ongoing risks.
• The success of clinical trials and the ability to enroll patients are subject to uncertainty.

Future Outlook

Atossa intends to continue pursuing patent protection around its current formulations in clinical development and believes its Continuation Patent Application will help refine patents on (Z)-endoxifen, potentially increasing its commercial value and competitiveness.

Management Comments

• Dr. Steven Quay, M.D., Ph.D., FCAP, CEO of Atossa Therapeutics, stated that the company is dedicated to providing better treatment options to patients.
• He also mentioned that while they disagree with the PTAB's decision, they will focus on continuing to get additional patent protection in the Patent Office since it has no impact on the formulations that are currently under clinical development.

Industry Context

Atossa's focus on (Z)-endoxifen as a SERM for breast cancer prevention and treatment places it within the competitive landscape of companies developing hormonal therapies for breast cancer, such as tamoxifen. The company's efforts to secure patent protection are crucial for maintaining a competitive advantage in this market.

Comparison to Industry Standards

• Companies like AstraZeneca (developing endocrine therapies like Faslodex) and Novartis (developing targeted therapies like Kisqali) are key players in the breast cancer treatment market.
• Atossa's (Z)-endoxifen aims to offer improved efficacy and tolerability compared to existing SERMs like tamoxifen, potentially addressing unmet needs in patients with resistance or intolerance to current treatments.
• The success of Atossa's clinical trials and patent protection efforts will determine its ability to compete effectively with these established players.

Stakeholder Impact

• Shareholders may react negatively to the PTAB ruling but positively to the new patent issuance.
• Patients may benefit from the continued development of (Z)-endoxifen as a potential breast cancer treatment.
• The company's employees will continue to work on the development and patent protection of (Z)-endoxifen.

Next Steps

• Atossa intends to continue to pursue patent protection around the Company's current formulations in clinical development, including in a new Continuation Patent Application to be filed with the U.S. Patent Office.
• The company will continue to study (Z)-endoxifen in five Phase 2 trials.

Key Dates

Keywords

Atossa Therapeutics, (Z)-endoxifen, Patent Trial and Appeal Board, PTAB, U.S. Patent No. 12, 201, 591, U.S. Patent No. 11, 572, 334, Patent, Breast Cancer, Clinical Development, Pharmaceuticals