Atossa Therapeutics Announces Issuance of U.S. Patent No. 12,281,056, Including 58 Claims Covering Various Formulations for its (Z)-endoxifen Portfolio
Atossa Therapeutics (Nasdaq: ATOS) has secured a significant patent victory with the issuance of U.S. Patent No. 12,281,056 by the USPTO. The patent includes 58 claims covering (Z)-endoxifen formulations and therapeutic methods for their use.
The new patent specifically protects highly pure and stable enteric oral formulations of (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM). This development strengthens Atossa's intellectual property portfolio in breast cancer treatment innovation.
Led by CEO Steven Quay, M.D., Ph.D., the company continues to expand its patent estate, which now includes multiple U.S. patents with over 200 patent claims related to (Z)-endoxifen formulations and clinical applications. This strategic protection reinforces Atossa's position in developing targeted therapies for hormone receptor-positive breast cancer.
Atossa Therapeutics (Nasdaq: ATOS) ha ottenuto una significativa vittoria brevettuale con il rilascio del Brevetto USA n. 12.281.056 da parte dell'USPTO. Il brevetto comprende 58 rivendicazioni riguardanti formulazioni di (Z)-endoxifene e metodi terapeutici per il loro utilizzo.
Il nuovo brevetto protegge specificamente formulazioni orali enteriche altamente pure e stabili di (Z)-endoxifene, un potente Modulatore Selettivo del Recettore degli Estrogeni (SERM). Questo sviluppo rafforza il portafoglio di proprietà intellettuale di Atossa nell'innovazione del trattamento del cancro al seno.
Guidata dal CEO Steven Quay, M.D., Ph.D., l'azienda continua ad ampliare il suo patrimonio brevettuale, che ora include diversi brevetti USA con oltre 200 rivendicazioni relative a formulazioni di (Z)-endoxifene e applicazioni cliniche. Questa protezione strategica consolida la posizione di Atossa nello sviluppo di terapie mirate per il cancro al seno positivo ai recettori ormonali.
Atossa Therapeutics (Nasdaq: ATOS) ha logrado una importante victoria en patentes con la emisión de la Patente de EE.UU. No. 12,281,056 por parte de la USPTO. La patente incluye 58 reivindicaciones que cubren formulaciones de (Z)-endoxifeno y métodos terapéuticos para su uso.
La nueva patente protege específicamente formulaciones orales entéricas altamente puras y estables de (Z)-endoxifeno, un potente Modulador Selectivo del Receptor de Estrógeno (SERM). Este avance fortalece la cartera de propiedad intelectual de Atossa en la innovación del tratamiento del cáncer de mama.
Bajo la dirección del CEO Steven Quay, M.D., Ph.D., la compañía continúa ampliando su patrimonio de patentes, que ahora incluye múltiples patentes estadounidenses con más de 200 reivindicaciones relacionadas con formulaciones de (Z)-endoxifeno y aplicaciones clínicas. Esta protección estratégica refuerza la posición de Atossa en el desarrollo de terapias dirigidas para el cáncer de mama positivo para receptores hormonales.
Atossa Therapeutics (나스닥: ATOS)는 미국 특허청(USPTO)으로부터 미국 특허 번호 12,281,056을 획득하며 중요한 특허 승리를 거두었습니다. 이 특허는 (Z)-엔도시펜 제형 및 이의 치료 방법에 관한 58개의 청구항을 포함하고 있습니다.
새 특허는 강력한 선택적 에스트로겐 수용체 조절제(SERM)인 (Z)-엔도시펜의 고순도 및 안정적인 장용성 경구 제형을 특별히 보호합니다. 이로써 Atossa의 유방암 치료 혁신에 대한 지적 재산권 포트폴리오가 강화되었습니다.
CEO Steven Quay 박사(의학박사, 철학박사)의 지도 아래 회사는 (Z)-엔도시펜 제형 및 임상 적용과 관련된 200개 이상의 청구항을 포함하는 다수의 미국 특허를 보유하며 특허 자산을 지속적으로 확장하고 있습니다. 이러한 전략적 보호는 호르몬 수용체 양성 유방암을 위한 표적 치료제 개발에서 Atossa의 입지를 강화합니다.
Atossa Therapeutics (Nasdaq : ATOS) a remporté une victoire importante en matière de brevets avec la délivrance du brevet américain n° 12 281 056 par l’USPTO. Ce brevet comprend 58 revendications couvrant les formulations de (Z)-endoxifène et les méthodes thérapeutiques associées.
Le nouveau brevet protège spécifiquement des formulations orales entériques hautement pures et stables de (Z)-endoxifène, un puissant modulateur sélectif des récepteurs aux œstrogènes (SERM). Cette avancée renforce le portefeuille de propriété intellectuelle d’Atossa dans l’innovation du traitement du cancer du sein.
Sous la direction du PDG Steven Quay, M.D., Ph.D., la société continue d’élargir son portefeuille de brevets, qui comprend désormais plusieurs brevets américains avec plus de 200 revendications relatives aux formulations de (Z)-endoxifène et à leurs applications cliniques. Cette protection stratégique consolide la position d’Atossa dans le développement de thérapies ciblées pour le cancer du sein hormono-dépendant.
Atossa Therapeutics (Nasdaq: ATOS) hat einen bedeutenden Patentsieg errungen mit der Erteilung des US-Patents Nr. 12.281.056 durch das USPTO. Das Patent umfasst 58 Ansprüche, die (Z)-Endoxifen-Formulierungen und therapeutische Anwendungsweisen abdecken.
Das neue Patent schützt speziell hochreine und stabile enterische orale Formulierungen von (Z)-Endoxifen, einem potenten Selektiven Estrogenrezeptor-Modulator (SERM). Diese Entwicklung stärkt das geistige Eigentum von Atossa im Bereich der Innovationen zur Behandlung von Brustkrebs.
Unter der Leitung von CEO Steven Quay, M.D., Ph.D., baut das Unternehmen sein Patentportfolio weiter aus, das nun mehrere US-Patente mit über 200 Patentansprüchen zu (Z)-Endoxifen-Formulierungen und klinischen Anwendungen umfasst. Dieser strategische Schutz festigt Atossas Position bei der Entwicklung zielgerichteter Therapien für hormonrezeptor-positiven Brustkrebs.
- New US patent granted with 58 claims covering (Z)-endoxifen formulations
- Expanded IP portfolio now includes over 200 patent claims related to (Z)-endoxifen
- Patent strengthens market position for breast cancer treatment development
- Enhanced protection for proprietary drug formulations and therapeutic methods
- Still in clinical-stage with no commercialized products
- Continued R&D expenses likely required for drug development
Insights
Atossa's new patent significantly strengthens IP protection for (Z)-endoxifen, creating valuable exclusivity for their breast cancer treatment formulations.
The USPTO's grant of patent No. 12,281,056 to Atossa Therapeutics represents a significant intellectual property milestone for their (Z)-endoxifen program. The patent's 58 distinct claims provide comprehensive coverage across formulation purity, stability parameters, and therapeutic methods of use - all critical elements for pharmaceutical exclusivity.
Particularly noteworthy is the protection of enteric oral formulations, which addresses both drug delivery challenges and patient compliance advantages. Enteric formulations specifically protect active compounds from degradation in stomach acid while enabling intestinal absorption, potentially improving both efficacy and tolerability profiles.
This patent strategically complements Atossa's existing portfolio that now encompasses multiple U.S. patents with over 200 claims related to (Z)-endoxifen. Such layered IP protection creates substantial barriers to potential competitors in the hormone receptor-positive breast cancer space.
From a technical perspective, securing formulation patents for a Selective Estrogen Receptor Modulator (SERM) like (Z)-endoxifen is particularly valuable given their established therapeutic class in breast cancer management. The specificity of claims covering "highly pure and stable" formulations suggests Atossa has developed manufacturing processes that potentially differentiate their product from generic alternatives that might emerge following any composition-of-matter patent expirations.
New patent strengthens Atossa's market exclusivity for (Z)-endoxifen, enhancing company valuation and potential partnership opportunities.
The USPTO granting Atossa's patent for (Z)-endoxifen formulations materially strengthens the company's competitive positioning in breast cancer therapeutics. For clinical-stage companies like Atossa, intellectual property assets constitute a critical valuation component, particularly given the significant R&D investments required to bring novel therapies to market.
This patent specifically protects the company's oral formulation technology - a delivery method that typically commands premium pricing and patient preference advantages compared to injectable alternatives. The comprehensive nature of the patent (58 claims covering various formulation aspects) provides Atossa multiple defensive layers against potential competitors.
From a corporate development perspective, robust patent protection significantly enhances Atossa's position for potential licensing negotiations or strategic partnerships with larger pharmaceutical companies that may be needed for later-stage development or commercialization.
CEO Steven Quay's statement that this will "enhance and accelerate our mission" while "generating substantial value for shareholders" indicates management's strategic focus on building IP barriers around their core technology. The company's systematic expansion to "multiple U.S. patents" with "over 200 patent claims" demonstrates a methodical approach to creating a defensible market position for their (Z)-endoxifen program.
While clinical and regulatory hurdles remain, this patent meaningfully strengthens Atossa's long-term commercial prospects assuming successful development.
SEATTLE, April 30, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced that the United States Patent and Trademark Office (USPTO) has granted a new patent (U.S. Patent No. 12,281,056) directed to highly pure and stable enteric oral formulations comprising (Z)-endoxifen as well as therapeutic methods of using those oral formulations.
The newly granted patent includes 58 claims covering (Z)-endoxifen formulations, including various levels of purity and stability as well as methods of using those formulations. This patent provides additional support for Atossa’s intellectual property portfolio surrounding its proprietary (Z)-endoxifen formulations, a potent Selective Estrogen Receptor Modulator (SERM).
“The issuance of U.S. Patent No. 12,281,056 further showcases the work of our team of innovative researchers and our commitment to protecting our intellectual property, which will enhance and accelerate our mission of advancing the treatment of breast cancer,” said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. “At Atossa, we are dedicated transforming the paradigm in breast cancer treatment, and we are confident that through this mission, we can greatly improve lives of millions of women who face breast cancer, while generating substantial value for our shareholders.”
Atossa continues to add to its robust patent estate, which includes multiple U.S. patents, collectively encompassing over 200 patent claims related to (Z)-endoxifen formulations and their clinical applications. This comprehensive and ongoing protection strategy bolsters the company's continued leadership in developing targeted therapies for hormone receptor-positive breast cancer.
About (Z)-Endoxifen
(Z)-endoxifen is one of the most potent Selective Estrogen Receptor Modulator (SERM) for estrogen receptor inhibition and may cause 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 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 clinical studies of women with and without breast cancer. (Z)-endoxifen is currently being studied both for the treatment and prevention of breast cancer, including a program in metastatic breast cancer that was announced earlier this year.
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 atossatherapeutics.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,” “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
michael.parks@atossainc.com
FAQ
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