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Atossa Therapeutics Granted Additional Patent Protection for Endoxifen

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Atossa Therapeutics (Nasdaq: ATOS) has been granted a new patent (U.S. Patent No. 12,071,391) by the United States Patent and Trademark Office (USPTO). This patent covers compositions comprising endoxifen (in free base or salt forms) and an enteric material, where at least 90% is (Z)-endoxifen. It also includes methods of administering these compositions to patients.

This is Atossa's fourth issued patent from the USPTO, expanding protection to include (Z)-endoxifen salt compositions and their usage methods. The company, a clinical-stage biopharmaceutical firm, focuses on developing innovative medicines for oncology, particularly breast cancer. CEO Steven Quay emphasized that this broader patent protection will create long-term stockholder value by further validating and expanding Atossa's patent portfolio beyond previously issued composition of matter patents.

Atossa Therapeutics (Nasdaq: ATOS) ha ricevuto un nuovo brevetto (Brevetto U.S. No. 12,071,391) dall'Ufficio Brevetti e Marchi degli Stati Uniti (USPTO). Questo brevetto copre composizioni contenenti endoxifene (in forma di base libera o di sali) e un materiale enterico, dove almeno il 90% è (Z)-endoxifene. Include anche metodi per somministrare queste composizioni ai pazienti.

Questo è il quarto brevetto rilasciato a Atossa dall'USPTO, estendendo la protezione per includere le composizioni di sali di (Z)-endoxifene e i loro metodi di utilizzo. L'azienda, una società biofarmaceutica in fase clinica, si concentra sullo sviluppo di farmaci innovativi per l'oncologia, in particolare per il cancro al seno. Il CEO Steven Quay ha sottolineato che questa protezione brevettuale più ampia creerà valore per gli azionisti a lungo termine, ulteriormente convalidando e ampliando il portafoglio brevetti di Atossa oltre ai precedenti brevetti di composizione di materia.

Atossa Therapeutics (Nasdaq: ATOS) ha recibido una nueva patente (Patente U.S. No. 12,071,391) de la Oficina de Patentes y Marcas de EE. UU. (USPTO). Esta patente cubre composiciones que comprenden endoxifeno (en formas de base libre o en sales) y un material enteral, donde al menos el 90% es (Z)-endoxifeno. También incluye métodos para administrar estas composiciones a los pacientes.

Esta es la cuarta patente emitida a Atossa por la USPTO, ampliando la protección para incluir las composiciones de sales de (Z)-endoxifeno y sus métodos de uso. La empresa, una firma biofarmacéutica en etapa clínica, se centra en desarrollar medicamentos innovadores para oncología, particularmente para el cáncer de mama. El CEO Steven Quay enfatizó que esta protección patentada más amplia creará valor a largo plazo para los accionistas, validando y ampliando aún más el portafolio de patentes de Atossa más allá de las patentes de composición de materia previamente emitidas.

Atossa Therapeutics (Nasdaq: ATOS)는 미국 특허청(USPTO)으로부터 새로운 특허(미국 특허 번호 12,071,391)를 부여받았습니다. 이 특허는 엔독시펜(자유 염기 또는 염 형태)와 장내 재료를 포함하는 조성을 포함하며, 이 조성의 90% 이상이 (Z)-엔독시펜입니다. 또한 이 조성을 환자에게 투여하는 방법도 포함됩니다.

이것은 Atossa가 USPTO로부터 네 번째로 발행된 특허로, (Z)-엔독시펜 염 조성과 그 사용 방법을 포함하도록 보호 범위를 확장합니다. 이 회사는 임상 단계의 생명공학 회사로, 특히 유방암에 대한 혁신적인 의약품 개발에 주력하고 있습니다. CEO인 Steven Quay는 이러한 더 넓은 특허 보호가 Atossa의 물질 조성 특허에 대한 검증 및 확장을 통해 주주에게 장기적인 가치를 창출할 것이라고 강조했습니다.

Atossa Therapeutics (Nasdaq: ATOS) a reçu un nouveau brevet (Brevet U.S. No. 12,071,391) de l'Office américain des brevets et des marques (USPTO). Ce brevet couvre des compositions comprenant endoxifène (sous forme de base libre ou de sels) et un matériau entérique, où au moins 90 % est du (Z)-endoxifène. Il inclut également des méthodes d'administration de ces compositions aux patients.

Ceci est le quatrième brevet délivré à Atossa par l'USPTO, élargissant la protection pour inclure les compositions de sels de (Z)-endoxifène et leurs méthodes d'utilisation. L'entreprise, une société biopharmaceutique en phase clinique, se concentre sur le développement de médicaments innovants pour l'oncologie, en particulier le cancer du sein. Le PDG Steven Quay a souligné que cette protection brevetaire élargie créera de la valeur à long terme pour les actionnaires en validant et en élargissant encore le portefeuille de brevets d'Atossa au-delà des brevets de composition de matière précédemment délivrés.

Atossa Therapeutics (Nasdaq: ATOS) wurde ein neues Patent (US-Patent Nr. 12,071,391) vom US-Patent- und Markenamt (USPTO) gewährt. Dieses Patent umfasst Zusammensetzungen, die Endoxifen (in freier Base oder in Salzformen) und ein enterisches Material enthalten, wobei mindestens 90 % (Z)-Endoxifen ausmachen. Es umfasst auch Methoden zur Verabreichung dieser Zusammensetzungen an Patienten.

Dies ist das vierte erteilte Patent von Atossa vom USPTO, das den Schutz auf (Z)-Endoxifen-Salz-Zusammensetzungen und deren Verwendungsmethoden ausweitet. Das Unternehmen, eine biopharmazeutische Firma in klinischer Phase, konzentriert sich auf die Entwicklung innovativer Medikamente für die Onkologie, insbesondere Brustkrebs. CEO Steven Quay betonte, dass dieser erweiterte Patentschutz langfristigen Aktionärswert schaffen wird, indem er Atossas Patenteportfolio über die zuvor erteilten Stoffzusammensetzungs-Patente hinaus weiter validiert und ausbaut.

Positive
  • Granted new patent (U.S. Patent No. 12,071,391) for endoxifen compositions
  • Fourth issued patent from USPTO, expanding protection for Atossa's technology
  • Patent covers both compositions and methods of administration
  • Potential for increased long-term stockholder value due to broader patent protection
Negative
  • None.

This patent grant significantly bolsters Atossa Therapeutics' intellectual property portfolio for endoxifen, a key compound in their breast cancer research. The new patent (U.S. Patent No. 12,071,391) covers specific compositions and administration methods of (Z)-endoxifen, which is important for maintaining market exclusivity.

The patent's focus on compositions with at least 90 percent (Z)-endoxifen suggests a high level of purity and potentially improved efficacy. This could be a competitive advantage in the oncology market, particularly for breast cancer treatments. The inclusion of enteric material in the patent implies a focus on oral delivery methods, which could enhance patient compliance and drug absorption.

While this patent strengthens Atossa's position, investors should note that patent protection doesn't guarantee market success. The true value will depend on the clinical efficacy of endoxifen and its ability to meet unmet medical needs in breast cancer treatment.

Atossa's focus on (Z)-endoxifen is noteworthy in the breast cancer treatment landscape. Endoxifen, a metabolite of tamoxifen, has shown promise in overcoming some limitations of its parent drug, particularly in patients who are poor metabolizers of tamoxifen.

The high purity requirement (>90% (Z)-endoxifen) in this patent suggests Atossa is targeting a more potent and potentially more effective formulation. This could lead to improved outcomes in breast cancer patients, especially those who don't respond well to current therapies.

However, it's important to remember that Atossa is still in the clinical stage. While this patent strengthens their intellectual property, the real test will be in demonstrating clinical efficacy and safety in ongoing and future trials. Investors should closely monitor Atossa's clinical progress to gauge the potential market impact of this patented formulation.

SEATTLE, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), today announced that the United States Patent and Trademark Office (USPTO) has granted a new patent (U.S. Patent No. 12,071,391) directed to compositions comprising endoxifen (in free base or salt forms) and an enteric material in which at least 90 percent of the endoxifen is (Z)-endoxifen. The patent also covers methods of administering those compositions to patients. 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.

“This fourth issued patent by the United States Patent and Trademark Office expands Atossa’s protection to include (Z)-endoxifen salt compositions and methods of using those,” said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. “The broader protection provided by this new patent will create long-term stockholder value as it further validates and expands Atossa’s patent protection beyond our previously issued composition of matter patents, including U.S. Patent No. 11,572,334.”

About (Z)-Endoxifen
(Z)-endoxifen is the most potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition and also causes estrogen receptor degradation. It has also been shown to have efficacy in the setting of patients with tumor resistance to other hormonal treatments. In addition to its potent anti-estrogen effects, (Z)-endoxifen has been shown to target PKCβ1, a known oncogenic protein, at clinically attainable blood concentrations. Finally, (Z)-endoxifen appears to deliver similar or even greater bone agonistic effects while resulting in little or no endometrial proliferative effects compared with standard treatments, like tamoxifen.

Atossa is developing 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 in the stomach convert a significant 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. (Z)-endoxifen is currently being studied in four Phase 2 trials: one in healthy women with measurable breast density, one in women diagnosed with ductal carcinoma in situ, and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by four 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 focus on using (Z)-endoxifen to prevent and treat breast cancer. For more information, please visit www.atossatherapeutics.com.

Contact
Michael Parks
VP, Investor and Public Relations
484-356-7105
michael.parks@atossainc.com

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,” “future,” or other comparable words. 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, such as data related to the (Z)-endoxifen program and the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, and potential milestones and growth opportunities for the Company, to differ materially from those projected or anticipated, including risks and uncertainties associated with: macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim and final clinical results; 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 remain compliant 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.


FAQ

What new patent has Atossa Therapeutics (ATOS) been granted?

Atossa Therapeutics has been granted U.S. Patent No. 12,071,391 by the USPTO, covering compositions comprising endoxifen and an enteric material, as well as methods of administering these compositions.

How many patents has Atossa Therapeutics (ATOS) been issued by the USPTO?

This is Atossa Therapeutics' fourth issued patent from the United States Patent and Trademark Office (USPTO).

What is the focus of Atossa Therapeutics' (ATOS) drug development?

Atossa Therapeutics is a clinical-stage biopharmaceutical company developing innovative medicines in oncology, with a particular focus on breast cancer.

How does the new patent affect Atossa Therapeutics' (ATOS) stockholder value?

According to CEO Steven Quay, the broader protection provided by this new patent is expected to create long-term stockholder value by further validating and expanding Atossa's patent protection.

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