Ainos Spotlighted in Water Tower Research Report on VELDONA Clinical Study for Sjogren’s Syndrome

Rhea-AI Summary

Ainos, Inc. (NASDAQ:AIMD) has been featured in a Water Tower Research report highlighting its upcoming VELDONA® clinical study for Sjogren's syndrome, set to begin in December 2024 in Taiwan. The study will enroll 24 patients to assess VELDONA®'s effectiveness in reducing dryness symptoms over 24-48 weeks. Key points include:

1. Taiwan FDA approval expected by November 2024
2. Trial projected to complete by January 2026
3. Primary endpoint: improvement of saliva secretion and dryness symptoms
4. Secondary endpoints: ESSPRI, ESSDAI, VAS, and salivary gland function
5. Sjogren's syndrome affects up to 1% of the global population
6. Previous U.S. Phase 3 data showed significant improvements

This study follows Ainos' capital-efficient strategy of conducting clinical trials in Taiwan, with a prior VELDONA study for oral warts in HIV+ patients planned for November 2024.

Positive

• Upcoming clinical study for VELDONA® in treating primary Sjogren's syndrome
• Capital-efficient strategy for conducting clinical trials in Taiwan
• Previous U.S. Phase 3 data demonstrated significant improvements for unstimulated whole saliva flow and oral dryness
• Targeting a rare autoimmune disease with treatment options
• Potential to address a market affecting up to 1% of the global population

Negative

• Clinical trial results and regulatory approvals are uncertain
• Competition from other potential therapies in development
• patient enrollment (24 patients) may affect study significance
• Extended timeline for study completion (projected January 2026)

Insights

Medical Research Analyst

The upcoming VELDONA clinical study for Sjogren's syndrome represents a significant opportunity for Ainos. With no approved curative therapies for this condition affecting up to 1% of the global population, there's a clear unmet medical need. The capital-efficient strategy of conducting trials in Taiwan could accelerate development timelines and reduce costs.

The study's design, focusing on 24 patients over 24-48 weeks, is relatively small but could provide valuable efficacy signals. The primary endpoint of improving saliva secretion and dryness symptoms directly addresses key patient concerns. Previous U.S. Phase 3 data showing significant improvements in unstimulated whole saliva flow and oral dryness is encouraging, suggesting potential for positive outcomes in this new trial.

However, investors should note that rare disease drug development carries inherent risks. The small patient population could make recruitment challenging and limit the statistical power of results. Additionally, while the Taiwan FDA approval is expected soon, regulatory processes can be unpredictable.

Financial Analyst

From a financial perspective, Ainos' approach to clinical development is noteworthy. Conducting trials in Taiwan likely offers significant cost savings compared to U.S.-based studies, which could extend the company's cash runway. With a market cap of just $3.78 million, capital efficiency is important for Ainos.

The Sjogren's syndrome market, while niche, represents a potentially lucrative opportunity. Rare disease treatments often command premium pricing, which could translate to substantial revenues if VELDONA proves effective and gains approval. However, the path to commercialization is long and uncertain.

Investors should consider the company's dual focus on AI-driven diagnostics and therapeutics. This diversification could provide multiple avenues for growth but may also stretch resources. The upcoming oral warts study in HIV+ patients adds another potential revenue stream, potentially de-risking the overall pipeline.

While positive trial results could significantly impact Ainos' valuation, the current micro-cap status suggests high risk and potential volatility. Careful monitoring of cash burn and clinical milestones will be important for assessing the company's long-term prospects.

Sjogren's Syndrome is a rare autoimmune disease with limited treatment options

Prior U.S. Phase 3 data demonstrated benefits

SAN DIEGO, CA / ACCESSWIRE / September 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, today announced that Water Tower Research ("WTR") has published a report highlighting the Company's upcoming clinical study for VELDONA^® in treating primary Sjogren's syndrome, targeted to begin in December 2024 in Taiwan.

The report emphasizes Ainos' capital-efficient strategy in conducting clinical trials within Taiwan. Following a planned November 2024 VELDONA study for oral warts in HIV+ patients, next will be a single-site clinical trial for Sjogren's syndrome. 24 patients will be enrolled to assess VELDONA^®'s effectiveness in reducing dryness symptoms over a 24 to 48-week period. Approval from Taiwan's Food and Drug Administration (TFDA) for the study is expected by November 2024, with the trial projected to complete by January 2026.

Key Highlights from the Report:

Sjogren's Syndrome Study: The primary endpoint is to evaluate VELDONA^® in the improvement of saliva secretion and dryness symptoms, with secondary endpoints of EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), a visual analog scale (VAS) and salivary gland function.

No Approved Therapies: Sjogren's syndrome, a systemic autoimmune disease, affects up to 1% of the global population, predominantly middle-aged women, and lacks approved curative therapies.

Previous U.S. Phase 3 Data: VELDONA^® demonstrated significant improvements for unstimulated whole saliva flow and oral dryness in previous U.S. clinical trials.

Link to the WTR report

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

When is Ainos (AIMD) starting its VELDONA clinical study for Sjogren's syndrome?

Ainos (AIMD) is targeting to begin its VELDONA clinical study for Sjogren's syndrome in December 2024 in Taiwan.

How many patients will be enrolled in Ainos' (AIMD) VELDONA study for Sjogren's syndrome?

Ainos (AIMD) plans to enroll 24 patients in its VELDONA clinical study for Sjogren's syndrome.

What is the primary endpoint of Ainos' (AIMD) VELDONA study for Sjogren's syndrome?

The primary endpoint of Ainos' (AIMD) VELDONA study for Sjogren's syndrome is to evaluate the improvement of saliva secretion and dryness symptoms.

When is Ainos (AIMD) expecting to complete its VELDONA clinical trial for Sjogren's syndrome?

Ainos (AIMD) projects to complete its VELDONA clinical trial for Sjogren's syndrome by January 2026.

What were the results of previous U.S. Phase 3 trials for VELDONA by Ainos (AIMD)?

Previous U.S. Phase 3 trials for VELDONA by Ainos (AIMD) demonstrated significant improvements for unstimulated whole saliva flow and oral dryness.