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[8-K] – MIRA PHARMACEUTICALS, INC. (MIRA) (CIK 0001904286)

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MIRA Pharmaceuticals reported new preclinical results showing its oral candidate Mira-55, a non-psychotropic marijuana analog, outperformed injected morphine in an established animal model of chronic inflammatory pain. The study found oral Mira-55 fully normalized pain thresholds and significantly reduced inflammation, while morphine delivered only partial, indirectly mediated swelling reduction.

This is the first time the program directly measured inflammation alongside pain. The data support a CB2 receptor–mediated anti-inflammatory mechanism and back the company’s plan to pursue an IND for chronic inflammatory pain. MIRA frames Mira-55 within the non-opioid pain space, noting a $70 billion market opportunity.

Key takeaways include pain normalization, inflammation reduction, and the potential convenience of oral administration versus injections. The company positions Mira-55’s dual approach—addressing both pain perception and inflammation—as a differentiated path in chronic inflammatory pain.

MIRA Pharmaceuticals ha riportato nuovi riscontri preclinici che mostrano il suo candidato orale , un analogo della marijuana non psicotropo, ha superato la morfina somministrata per via iniettata in un modello animale consolidato di dolore infiammatorio cronico. lo studio ha rilevato che Mira-55 orale ha normalizzato completamente le soglie di dolore e ridotto significativamente l'infiammazione, mentre la morfina ha fornito solo una riduzione parziale dell’edema, mediata indirettamente.

Questo è il primo caso in cui il programma ha misurato direttamente l’infiammazione insieme al dolore. I dati supportano un meccanismo anti-infiammatorio mediato dal recettore CB2 e sostengono il piano dell’azienda di perseguire un IND per il dolore infiammatorio cronico. MIRA inquadra Mira-55 nello spazio del dolore non oppioide, segnalando una opportunità di mercato di $70 miliardi.

I takeaways chiave includono la normalizzazione del dolore, la riduzione dell’infiammazione e la potenziale comodità della somministrazione orale rispetto alle iniezioni. L’azienda posiziona l’approccio duale di Mira-55—affrontando sia la percezione del dolore sia l’infiammazione—a percorso differenziato nel dolore infiammatorio cronico.

MIRA Pharmaceuticals informó nuevos resultados preclínicos que muestran su candidato oral , un análogo de la marihuana no psicotrópico, superó a la morfina inyectada en un modelo animal establecido de dolor inflamatorio crónico. El estudio encontró que Mira-55 oral normalizó completamente los umbrales de dolor y redujo significativamente la inflamación, mientras que la morfina solo proporcionó una reducción parcial e indirectamente mediada de la hinchazón.

Esta es la primera vez que el programa midió directamente la inflamación junto con el dolor. Los datos respaldan un mecanismo antiinflamatorio mediado por el receptor CB2 y respaldan el plan de la compañía de perseguir un IND para el dolor inflamatorio crónico. MIRA sitúa Mira-55 dentro del espacio de dolor no opioide, señalando una oportunidad de mercado de $70 mil millones.

Las conclusiones clave incluyen la normalización del dolor, la reducción de la inflamación y la posible conveniencia de la administración oral frente a las inyecciones. La empresa posiciona el enfoque dual de Mira-55—abordando tanto la percepción del dolor como la inflamación—a path diferenciador en el dolor inflamatorio crónico.

MIRA Pharmaceuticals는 경구 후보물질 , 비향정 대마 유사체가 만성 염증성 통증의 확립된 동물 모델에서 주사된 모르핀을 능가했다는 새로운 예비 임상 결과를 발표했다. 연구에 따르면 구강 Mira-55는 통증 역치를 완전히 정상화하고 염증을 크게 감소시켰으며, 모르핀은 부종 감소를 부분적으로만 간접적으로 이끌었다.

이번이 프로그램이 통증과 함께 염증을 직접 측정한 최초의 사례이다. 데이터는 CB2 수용체 매개 항염증 기전을 지지하며 만성 염증성 통증에 대한 IND를 추구하려는 회사의 계획을 뒷받침한다. MIRA는 Mira-55를 비마약성 통증 영역으로 분류하고 $70 billion의 시장 기회를 주목한다.

주요 시사점은 통증의 정상화, 염증 감소, 주사에 비해 구강 투여의 편의성 가능성을 포함한다. 회사는 Mira-55의 이중 접근법—통증 지각과 염증 모두를 다루는 것—을 만성 염증성 통증에서 차별화된 경로로 제시한다.

MIRA Pharmaceuticals a publié de nouveaux résultats précliniques montrant son candidat oral , un analogue non psychotrope du cannabis, a surpassé la morphine injectée dans un modèle animal établi de douleur inflammatoire chronique. L’étude a montré que Mira-55 oral a complètement normalisé les seuils de douleur et a réduit significativement l’inflammation, tandis que la morphine n’a apporté qu’une réduction partielle et indirecte de l’enflure.

C’est la première fois que le programme mesure directement l’inflammation en même temps que la douleur. Les données soutiennent un mécanisme anti-inflammatoire médié par le récepteur CB2 et étayent le plan de l’entreprise de poursuivre un IND pour la douleur inflammatoire chronique. MIRA cadre Mira-55 dans l’espace de la douleur non-opioïde, soulignant une opportunité de marché de $70 milliards.

Les points clés comprennent la normalisation de la douleur, la réduction de l’inflammation et la commodité potentielle d’une administration orale par rapport aux injections. L’entreprise présente l’approche double de Mira-55—aborder à la fois la perception de la douleur et l’inflammation—comme une voie différenciée dans la douleur inflammatoire chronique.

MIRA Pharmaceuticals berichtet von neuen präklinischen Ergebnissen, die ihren oralen Kandidaten , ein nicht-psychotroper Cannabis-Analoga, übertraf die injizierte Morphin in einem etablierten Tierversuchmodell chronischer entzündlicher Schmerzen. Die Studie zeigte, dass orales Mira-55 die Schmerzschwellen vollständig normalisierte und deutlich Entzündungen reduzierte, während Morphin nur eine teilweise, indirekt vermittelten Schwellungsreduktion ermöglichte.

Dies ist das erste Mal, dass das Programm Entzündung direkt zusammen mit Schmerz gemessen hat. Die Daten unterstützen einen entzündungshemmenden Mechanismus, der durch den CB2-Rezeptor vermittelt wird und stützen den Plan des Unternehmens, eine IND für chronische entzündliche Schmerzen anzustreben. MIRA positioniert Mira-55 im Bereich der nicht-opioiden Schmerzlinderung und weist auf eine Marktchance von $70 Milliarden hin.

Schlüssel-Botschaften sind Schmerznormalisierung, Entzündungsreduktion und der potenzielle Vorteil der oralene Verabreichung gegenüber Injektionen. Das Unternehmen präsentiert Mira-55s dualen Ansatz – sowohl Schmerzempfinden als auch Entzündung anzugehen – als differenzierte Route bei chronischen entzündlichen Schmerzen.

MIRA Pharmaceuticals أبلغت عن نتائج جديدة في مراحل ما قبل السريرية تُظهر المرشح الفموي ، وهو تحليل غير مهدئ من القنب، تفوّق على المورفين المُعطى بالحقن في نموذج حيواني قائم جيداً لآلام التهابية مزمنة. وجدت الدراسة أن Mira-55 الفموي قد عيّن عتبات الألم بشكل كامل و< b>قلّلت الالتهاب بشكل ملحوظ، بينما المورفين قدم تقليلاً جزئياً فقط لحدوث التورم بطريقة غير مباشرة.

هذه هي المرة الأولى التي قيس فيها الالتهاب جنباً إلى جنب مع الألم بشكل مباشر في البرنامج. تدعم البيانات آلية مضادة للالتهاب مستمدة من مستقبل CB2 وتؤيد خطة الشركة للسعي إلى IND لآلام التهابية مزمنة. تُبرز MIRA Mira-55 ضمن فضاء الألم غير الأوبيوي، مع الإشارة إلى فرصة سوقية تبلغ $70 مليار.

تشمل النقاط الأساسية تطبيع الألم، تقليل الالتهاب، وإمكانية راحة الإدارة الفموية مقارنة بالحقن. تبرز الشركة نهج Mira-55 المزدوج—معالجة كل من إدراك الألم والالتهاب—كمسار مميّز في الألم الالتهابي المزمن.

MIRA Pharmaceuticals 报告了新的临床前结果,显示其口服候选药物 ,一种非精神活性的大麻类似物,在已建立的慢性炎症性疼痛动物模型中 优于静脉注射吗啡。该研究发现口服 Mira-55 能完全使疼痛阈值恢复正常,并且 显著降低炎症,而吗啡仅提供部分、间接介导的肿胀降低。

这是该项目首次在同一研究中直接同时衡量炎症和疼痛。数据支持一个 CB2受体介导的抗炎机制,并支持公司推进针对慢性炎症性疼痛的 IND 的计划。MIRA 将 Mira-55 定位于非阿片类疼痛领域,指出一个 $70 billion 的市场机会。

要点包括疼痛的正常化、炎症的减少,以及与注射相比的潜在口服给药便利性。公司将 Mira-55 的双重路径——同时解决疼痛感知与炎症——定位为慢性炎症性疼痛的差异化路径。

Positive
  • None.
Negative
  • None.

Insights

Preclinical oral efficacy and anti-inflammatory signal support an IND path.

The results indicate oral Mira-55 normalized pain thresholds and reduced inflammation in a chronic inflammatory pain animal model, while injected morphine achieved only partial swelling reduction. The study newly measured inflammation, aligning with a CB2 receptor mechanism that targets both pain and inflammatory drivers.

Because these are preclinical animal data, translational outcomes remain uncertain until human studies commence under an IND. The oral route could be clinically convenient if efficacy and safety translate, especially relative to injection-dependent comparators.

On October 15, 2025, the company linked the findings to its planned IND for chronic inflammatory pain and referenced a $70 billion non-opioid pain market. Actual clinical progress will depend on subsequent regulatory interactions and trial results.

MIRA Pharmaceuticals ha riportato nuovi riscontri preclinici che mostrano il suo candidato orale , un analogo della marijuana non psicotropo, ha superato la morfina somministrata per via iniettata in un modello animale consolidato di dolore infiammatorio cronico. lo studio ha rilevato che Mira-55 orale ha normalizzato completamente le soglie di dolore e ridotto significativamente l'infiammazione, mentre la morfina ha fornito solo una riduzione parziale dell’edema, mediata indirettamente.

Questo è il primo caso in cui il programma ha misurato direttamente l’infiammazione insieme al dolore. I dati supportano un meccanismo anti-infiammatorio mediato dal recettore CB2 e sostengono il piano dell’azienda di perseguire un IND per il dolore infiammatorio cronico. MIRA inquadra Mira-55 nello spazio del dolore non oppioide, segnalando una opportunità di mercato di $70 miliardi.

I takeaways chiave includono la normalizzazione del dolore, la riduzione dell’infiammazione e la potenziale comodità della somministrazione orale rispetto alle iniezioni. L’azienda posiziona l’approccio duale di Mira-55—affrontando sia la percezione del dolore sia l’infiammazione—a percorso differenziato nel dolore infiammatorio cronico.

MIRA Pharmaceuticals informó nuevos resultados preclínicos que muestran su candidato oral , un análogo de la marihuana no psicotrópico, superó a la morfina inyectada en un modelo animal establecido de dolor inflamatorio crónico. El estudio encontró que Mira-55 oral normalizó completamente los umbrales de dolor y redujo significativamente la inflamación, mientras que la morfina solo proporcionó una reducción parcial e indirectamente mediada de la hinchazón.

Esta es la primera vez que el programa midió directamente la inflamación junto con el dolor. Los datos respaldan un mecanismo antiinflamatorio mediado por el receptor CB2 y respaldan el plan de la compañía de perseguir un IND para el dolor inflamatorio crónico. MIRA sitúa Mira-55 dentro del espacio de dolor no opioide, señalando una oportunidad de mercado de $70 mil millones.

Las conclusiones clave incluyen la normalización del dolor, la reducción de la inflamación y la posible conveniencia de la administración oral frente a las inyecciones. La empresa posiciona el enfoque dual de Mira-55—abordando tanto la percepción del dolor como la inflamación—a path diferenciador en el dolor inflamatorio crónico.

MIRA Pharmaceuticals는 경구 후보물질 , 비향정 대마 유사체가 만성 염증성 통증의 확립된 동물 모델에서 주사된 모르핀을 능가했다는 새로운 예비 임상 결과를 발표했다. 연구에 따르면 구강 Mira-55는 통증 역치를 완전히 정상화하고 염증을 크게 감소시켰으며, 모르핀은 부종 감소를 부분적으로만 간접적으로 이끌었다.

이번이 프로그램이 통증과 함께 염증을 직접 측정한 최초의 사례이다. 데이터는 CB2 수용체 매개 항염증 기전을 지지하며 만성 염증성 통증에 대한 IND를 추구하려는 회사의 계획을 뒷받침한다. MIRA는 Mira-55를 비마약성 통증 영역으로 분류하고 $70 billion의 시장 기회를 주목한다.

주요 시사점은 통증의 정상화, 염증 감소, 주사에 비해 구강 투여의 편의성 가능성을 포함한다. 회사는 Mira-55의 이중 접근법—통증 지각과 염증 모두를 다루는 것—을 만성 염증성 통증에서 차별화된 경로로 제시한다.

MIRA Pharmaceuticals a publié de nouveaux résultats précliniques montrant son candidat oral , un analogue non psychotrope du cannabis, a surpassé la morphine injectée dans un modèle animal établi de douleur inflammatoire chronique. L’étude a montré que Mira-55 oral a complètement normalisé les seuils de douleur et a réduit significativement l’inflammation, tandis que la morphine n’a apporté qu’une réduction partielle et indirecte de l’enflure.

C’est la première fois que le programme mesure directement l’inflammation en même temps que la douleur. Les données soutiennent un mécanisme anti-inflammatoire médié par le récepteur CB2 et étayent le plan de l’entreprise de poursuivre un IND pour la douleur inflammatoire chronique. MIRA cadre Mira-55 dans l’espace de la douleur non-opioïde, soulignant une opportunité de marché de $70 milliards.

Les points clés comprennent la normalisation de la douleur, la réduction de l’inflammation et la commodité potentielle d’une administration orale par rapport aux injections. L’entreprise présente l’approche double de Mira-55—aborder à la fois la perception de la douleur et l’inflammation—comme une voie différenciée dans la douleur inflammatoire chronique.

MIRA Pharmaceuticals berichtet von neuen präklinischen Ergebnissen, die ihren oralen Kandidaten , ein nicht-psychotroper Cannabis-Analoga, übertraf die injizierte Morphin in einem etablierten Tierversuchmodell chronischer entzündlicher Schmerzen. Die Studie zeigte, dass orales Mira-55 die Schmerzschwellen vollständig normalisierte und deutlich Entzündungen reduzierte, während Morphin nur eine teilweise, indirekt vermittelten Schwellungsreduktion ermöglichte.

Dies ist das erste Mal, dass das Programm Entzündung direkt zusammen mit Schmerz gemessen hat. Die Daten unterstützen einen entzündungshemmenden Mechanismus, der durch den CB2-Rezeptor vermittelt wird und stützen den Plan des Unternehmens, eine IND für chronische entzündliche Schmerzen anzustreben. MIRA positioniert Mira-55 im Bereich der nicht-opioiden Schmerzlinderung und weist auf eine Marktchance von $70 Milliarden hin.

Schlüssel-Botschaften sind Schmerznormalisierung, Entzündungsreduktion und der potenzielle Vorteil der oralene Verabreichung gegenüber Injektionen. Das Unternehmen präsentiert Mira-55s dualen Ansatz – sowohl Schmerzempfinden als auch Entzündung anzugehen – als differenzierte Route bei chronischen entzündlichen Schmerzen.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): October 15, 2025

 

 

MIRA PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Florida   001-41765   85-3354547

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

1200 Brickell Avenue, Suite 1950 #1183
Miami, Florida 33131
(Address of Principal Executive Offices)

 

Registrant’s telephone number, including area code: (786) 432-9792

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
     
  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
     
  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
     
  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of each exchange on which registered
Common Stock, $0.0001 par value per share   MIRA   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

 

 

Item 8.01 Other Events

 

MIRA Pharmaceuticals Announces Oral Mira-55 Outperformed Injected Morphine in Normalizing Pain and Reducing Inflammation, Supporting Its Planned IND for Chronic Inflammatory Pain

 

Findings show oral Mira-55 fully normalized pain and significantly reduced inflammation, supporting IND plans and reinforcing MIRA’s position in a $70 billion non-opioid pain market.

 

On October 15, 2025, MIRA Pharmaceuticals, Inc. (the “Company”) announced new preclinical data for Mira-55, its proprietary non-psychotropic marijuana analog, showing that oral administration of Mira-55 normalized pain and significantly reduced inflammation, outperforming injected morphine in an established animal model of chronic inflammatory pain.

 

This study marks the first time inflammation was directly measured alongside pain in the Mira-55 program. In the Company’s prior study, only pain sensitivity was assessed, with both Mira-55 and morphine administered by injection. The new data demonstrate that orally administered Mira-55 provided superior pain normalization and direct anti-inflammatory effects, while morphine produced only partial and indirect inflammation reduction.

 

Key observations from the study include:

 

  Pain normalization: Oral Mira-55 restored pain thresholds to baseline levels and outperformed injected morphine in reversing formalin-induced pain sensitivity.
  Inflammation reduction: Mira-55 significantly reduced paw edema, confirming a direct CB2-receptor-mediated anti-inflammatory mechanism, whereas morphine reduced swelling only partially through indirect, centrally mediated effects.
  Oral advantage: Mira-55’s efficacy via oral administration highlights a potential clinical convenience compared with morphine, which required injection to achieve its effects.

 

Reducing inflammation is fundamental to treating pain effectively. Inflammation drives nerve sensitization and amplifies pain signaling. Opioids block pain perception in the brain but do not treat inflammation, while NSAIDs address inflammation but carry safety concerns. By directly targeting inflammation through CB2 receptor activation, Mira-55 addresses both the cause and the perception of pain, offering a differentiated dual mechanism for chronic inflammatory pain conditions.

 

These findings support the Company’s plan to pursue an Investigational New Drug (IND) application for chronic inflammatory pain and strengthen the scientific basis for advancing Mira-55 within its non-opioid pain franchise.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  MIRA PHARMACEUTICALS, INC.
   
Dated: October 15, 2025 By: /s/ Erez Aminov
  Name: Erez Aminov
  Title: Chief Executive Officer

 

 

 

 

FAQ

What did MIRA (MIRA) announce about Mira-55?

MIRA reported preclinical data showing oral Mira-55 fully normalized pain and significantly reduced inflammation in an animal model, outperforming injected morphine.

How does Mira-55 compare to morphine in the study?

Oral Mira-55 outperformed injected morphine by normalizing pain thresholds and directly reducing inflammation; morphine only partially reduced swelling via indirect effects.

What mechanism does Mira-55 target?

The findings support a CB2 receptor–mediated anti-inflammatory mechanism, addressing both pain perception and inflammation.

What is the next step for Mira-55?

The results support the company’s plan to pursue an IND application for chronic inflammatory pain.

Why is oral administration notable for Mira-55?

The data highlight efficacy via oral dosing, which may offer clinical convenience compared with agents requiring injection.

What market context did MIRA mention?

MIRA referenced participation in a non-opioid pain market described as about $70 billion.
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