Ainos Highlights VELDONA Clinical Advancements and Market Potential in Water Tower Research Spotlight Podcast
Rhea-AI Summary
Ainos (NASDAQ:AIMD) showcased VELDONA®'s clinical progress and market potential in a Water Tower Research podcast. VELDONA®, an oral low-dose interferon-α therapeutic, has undergone 68 clinical studies across 16 indications with 6,000 participants, demonstrating strong safety. The company is focusing on two human studies in Taiwan: oral warts in HIV+ patients and Sjogren's syndrome. Previous trials showed over 75% reduction in wart-affected areas. In animal health, Ainos is exploring VELDONA®'s potential for feline chronic gingivostomatitis. Key milestones include completing the FCGS study by March 2025, filing FDA IND in 2025, completing Taiwan human studies in early 2026, and exploring global licensing opportunities.
Positive
- Extensive clinical validation with 68 studies across 16 indications and 6,000 participants
- Previous trials showed over 75% efficacy in wart reduction
- Targeting unmet medical needs with no approved therapies (oral warts in HIV+ patients)
- Potential market opportunity in Sjogren's syndrome affecting up to 3.1 million adults globally
- Additional market opportunity in pet care sector with FCGS affecting up to 10% of cats
Negative
- Still pending FDA IND application, indicating early development stage in US market
- Multiple clinical trials and regulatory approvals still required before commercialization
Insights
VELDONA's clinical development shows promise but faces significant hurdles ahead. The 68 clinical studies across 16 indications with 6,000 participants provide a robust safety database, particularly noteworthy for a rare disease therapeutic. The 75% reduction in oral wart affected area in HIV+ patients is clinically meaningful, especially given the current lack of approved treatments.
However, several critical factors warrant attention. The upcoming Taiwan studies are relatively small-scale and regional. The planned FDA IND filing in 2025 suggests a long regulatory pathway ahead, as Phase 1-3 studies in the US would still be required. The dual focus on both human and veterinary applications, while expanding market potential, could strain resources for this
The Sjögren's syndrome indication faces intense competition from established pharma companies, though positive Phase 3 data showing improved saliva and tear production provides some competitive advantage.
Prioritizing VELDONA®'s development for oral warts in HIV+ patients and Sjogren's syndrome
Burgeoning pet care market also presents growth opportunities for VELDONA®
SAN DIEGO, CA / ACCESSWIRE / October 24, 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, shared promising clinical progress of VELDONA® and its growth opportunities alongside upcoming milestones in the Water Tower Research ("WTR") Small-Cap Spotlight podcast, signaling strong potential for both human and animal health markets. WTR has published a report recapping highlights from the podcast.
Key Highlights from the Report:
Safe, Oral Low-DoseInterferon-α ("IFN-α") Therapeutic: VELDONA® is an oral lozenge formulation of IFN-α at a significantly lower dose than traditional injectable therapies. It offers a safer approach by modulating the immune system to treat viral infections or autoimmune conditions.
Extensive Clinical History: After 68 clinical studies across 16 indications with approximately 6,000 trial participants, VELDONA® demonstrated a strong safety profile compared to injectable versions, with notable clinical benefits. It has also been evaluated across 28 animal clinical studies.
Rare Disease Focus: Ainos is prioritizing VELDONA®'s development in two human studies in Taiwan for oral warts in HIV+ patients and Sjogren's syndrome, two conditions with limited treatment options. Oral warts, affecting about
2% of HIV+ individuals, currently have no approved therapies, while past VELDONA® trials have shown more than75% of reduction in a wart's affected area. For Sjogren's, estimated to be impacting up to 3.1 million adults worldwide, VELDONA® demonstrated improvement in saliva and tear production in earlier Phase 3 studies.Animal Health Potential: The growing pet care market also presents growth opportunities for VELDONA®. Ainos is exploring its use in treating feline chronic gingivostomatitis ("FCGS"), a severe oral gum disease estimated to be affecting as many as
10% of cats, with limited treatment options.Milestones for Next 18 Months: Ainos anticipates the completion of the FCGS study by March 2025. Additionally, Ainos plans to file an investigational new drug (IND) application with the Food and Drug Administration (FDA) in 2025, complete Taiwan human studies in early 2026, and explore out-licensing opportunities for the development of VELDONA® worldwide.
Interested parties can listen to this podcast on Apple Podcasts, Spotify, or via the WTR website.
For more information and to access the full report, please visit WTR website.
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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