Water Tower Research Highlights IRB Approval for the Ainos VELDONA Clinical Sjogren's Trial Alongside 3Q24 Earnings and Developments
Water Tower Research has published a report highlighting Ainos (NASDAQ:AIMD) receiving IRB approval from Shuang Ho Hospital for its VELDONA clinical study in primary Sjogren's syndrome. The trial is expected to begin around April 2025 after TFDA approval, with completion targeted for December 2026. The study will enroll 24 patients over 24-48 weeks to evaluate VELDONA's efficacy in improving salivary flow. Previous U.S. Phase 3 studies showed positive results. The company recently secured exclusive licenses to 28 patent assets for AI Nose VOC sensing, POCT, and other technologies. Ainos maintains sufficient cash to support operations through 2H25.
Water Tower Research ha pubblicato un rapporto che evidenzia come Ainos (NASDAQ:AIMD) abbia ricevuto l'approvazione IRB dall'ospedale Shuang Ho per il suo studio clinico VELDONA sulla sindrome di Sjögren primaria. Si prevede che il trial inizi intorno ad aprile 2025 dopo l'approvazione della TFDA, con un completamento previsto per dicembre 2026. Lo studio recluterà 24 pazienti nell'arco di 24-48 settimane per valutare l'efficacia di VELDONA nel migliorare il flusso salivare. Precedenti studi di fase 3 negli Stati Uniti hanno mostrato risultati positivi. Recentemente, l'azienda ha ottenuto licenze esclusive per 28 asset brevettuali per la tecnologia di rilevamento VOC tramite AI Nose, POCT e altre tecnologie. Ainos mantiene liquidità sufficiente per supportare le operazioni fino alla seconda metà del 2025.
Water Tower Research ha publicado un informe que destaca cómo Ainos (NASDAQ:AIMD) ha recibido la aprobación IRB del Hospital Shuang Ho para su estudio clínico VELDONA en el síndrome de Sjögren primario. Se espera que el ensayo comience alrededor de abril de 2025 tras la aprobación de la TFDA, con una finalización prevista para diciembre de 2026. El estudio reclutará a 24 pacientes durante 24-48 semanas para evaluar la eficacia de VELDONA en mejorar el flujo salival. Estudios previos de fase 3 en EE. UU. mostraron resultados positivos. La empresa ha obtenido recientemente licencias exclusivas para 28 activos de patentes para detección de VOC con AI Nose, POCT y otras tecnologías. Ainos mantiene suficiente liquidez para apoyar sus operaciones hasta la segunda mitad de 2025.
Water Tower Research는 Ainos(NASDAQ:AIMD)가 Sjögren 증후군 및 샤웅 호 병원으로부터 VELDONA 임상 연구에 대한 IRB 승인을 받았다는 보고서를 발표했습니다. 임상 시험은 TFDA 승인을 받은 후 2025년 4월경에 시작될 것으로 예상됩니다며, 2026년 12월에 완료될 계획입니다. 이 연구에는 24명의 환자가 24-48주 동안 등록되어 VELDONA가 침샘 분비를 개선하는 효과를 평가할 예정입니다. 이전의 미국 3상 연구에서는 긍정적인 결과가 나타났습니다. 또한 회사는 AI Nose VOC 센싱, POCT 및 기타 기술에 대한 28개의 특허 자산에 대한 독점 라이센스를 최근에 확보했습니다. Ainos는 2025년 하반기까지 운영을 지원할 충분한 현금을 보유하고 있습니다.
Water Tower Research a publié un rapport soulignant qu'Ainos (NASDAQ:AIMD) a obtenu l'approbation IRB de l'hôpital Shuang Ho pour son étude clinique VELDONA sur le syndrome de Sjögren primaire. L'essai devrait commencer vers avril 2025 après l'approbation de la TFDA, avec une date de finalisation prévue pour décembre 2026. L'étude recrutera 24 patients sur une période de 24 à 48 semaines pour évaluer l'efficacité de VELDONA dans l'amélioration du flux salivaire. Des études précédentes de Phase 3 aux États-Unis ont montré des résultats positifs. Récemment, la société a obtenu des licences exclusives pour 28 actifs de brevets concernant la détection VOC par AI Nose, le POCT et d'autres technologies. Ainos dispose de suffisamment de liquidités pour soutenir ses opérations jusqu'au second semestre 2025.
Water Tower Research hat einen Bericht veröffentlicht, der hervorhebt, dass Ainos (NASDAQ:AIMD) die IRB-Zulassung des Shuang Ho Krankenhauses für die VELDONA klinische Studie bei primärem Sjögren-Syndrom erhalten hat. Die Studie soll voraussichtlich im April 2025 beginnen nach der Genehmigung durch die TFDA, mit einer Zielabschlußdatum im Dezember 2026. In der Studie werden 24 Patienten über 24-48 Wochen aufgenommen, um die Wirksamkeit von VELDONA zur Verbesserung des Speichelflusses zu bewerten. Frühere US-Studien der Phase 3 zeigten positive Ergebnisse. Das Unternehmen hat kürzlich exklusive Lizenzen für 28 Patentverwertungen für AI Nose VOC-Analyse, POCT und andere Technologien gesichert. Ainos verfügt über ausreichende liquide Mittel, um den Betrieb bis zur zweiten Hälfte von 2025 zu unterstützen.
- Received IRB approval for VELDONA clinical trial in Sjogren's syndrome
- Secured exclusive licenses to 28 patent assets for key technologies
- Cash runway extends through second half of 2025
- Previous Phase 3 studies showed positive results for VELDONA
- Clinical trial completion not expected until December 2026
- Small trial size of only 24 patients
Insights
The IRB approval for VELDONA's clinical trial in Sjogren's syndrome represents a significant milestone. The 24-patient trial targeting a disease affecting up to
The trial's timeline, with expected TFDA approval in Q1 2025 and completion by December 2026, is well-structured. The 24-48 week treatment duration is appropriate for evaluating chronic autoimmune conditions. The company's cash runway extending through 2H25 aligns with the trial's critical phases.
The expansion of patent portfolio with 28 new assets strengthens their IP position in AI-driven diagnostics and therapeutics. However, investors should note that clinical success and regulatory approval remain key hurdles before commercialization.
Taiwan regulatory approval for the trial expected in Q1 2025
Remains committed to a capital-efficient business strategy
SAN DIEGO, CA / ACCESSWIRE / November 13, 2024 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company"), an innovative healthcare company focused on advanced AI-driven point-of-care testing ("POCT") and low-dose interferon therapeutics, today announced that Water Tower Research ("WTR") has published a report on the Company's obtainment of Institutional Review Board ("IRB") approval from the Shuang Ho Hospital (Taipei Medical University) to conduct the VELDONA® clinical study for primary Sjogren's syndrome, along with 3Q24 results and multiple other developments.
The report said an approval from Taiwan's Food and Drug Administration (TFDA) for the study is expected in next quarter, with the trial set to start around April 2025 and completion in December 2026. The primary endpoint is to evaluate the efficacy of VELDONA in improving salivary flow and alleviating dryness symptoms in patients with primary Sjögren's syndrome, with an enrollment of 24 patients over 24 to 48 weeks.
Key Highlights from the Report:
No approved therapies: Sjogren's syndrome, which has a global prevalence of as much as
1% , causes dry eyes and mouth. Treatment for the indication are mainly symptom management without curative therapy.Prior studies demonstrate VELDONA® benefit: Previous U.S. Phase 3 studies showed VELDONA® improved unstimulated saliva flow and patient comfort.
Patent portfolio expansion: Ainos recently secured exclusive licenses to 28 patent assets for its AI Nose volatile organic compounds ("VOC") sensing, POCT, and nitrogen-oxygen separation technologies for healthcare.
Maintained capital efficiency and achieved multiple business advancements in 3Q24: Cash balance are expected to support operations through 2H25. Other developments include a VELDONA® patent for coronavirus, exclusive IP licenses for AI Nose and POCT, and validation for AI Nose application across industrial scenarios.
About Ainos, Inc.
Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on novel AI-powered point-of-care testing (POCT) and low-dose interferon therapeutics (VELDONA®). The Company's clinical-stage product pipeline includes VELDONA® human and animal oral therapeutics, human orphan drugs, and telehealth-friendly POCT solutions powered by its AI Nose technology platform.
The name "Ainos" is a combination of "AI" and "Nose" to reflect the Company's commitment to empowering individuals to manage their health more effectively with next-generation AI-driven POCT solutions. To learn more, visit https://www.ainos.com.
Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date.
Safe Harbor Statement
Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "approximate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements.
Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the products announced in this press release; the Company's dependence on projected revenues from the sale of current or future products; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos' product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the accuracy of third-party market research data, the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company's success in managing growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' Annual Report on Form 10-K for the year ended December 31, 2023, and other public filings with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's filings with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release.
The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Any forward-looking statements contained in this press release represent Ainos' views only as of today and should not be relied upon as representing its views as of any subsequent date. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.
Contact Information
Feifei Shen
ir@ainos.com
SOURCE: Ainos, Inc.
View the original press release on accesswire.com
FAQ
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