Five New Drug Candidates Show Promise as Ainos Pursues Licensing Partners of its Low-dose Oral Interferon Formulation

Rhea-AI Summary

Ainos, Inc. (NASDAQ: AIMD) has received positive FDA feedback on its Biologics License Application (BLA) for treating Sjögren's syndrome following two successful Phase 3 studies. The company is seeking out-licensing partnerships for five new drug candidates based on its low-dose oral interferon-alpha formulation, VELDONA®. These candidates have shown promising results in Phase 2 trials across various conditions, including aphthous stomatitis and influenza. Ainos aims to accelerate the commercialization of VELDONA® through these collaborations, having invested nearly $40 million in its development.

Positive

• Positive FDA feedback on BLA for Sjögren's syndrome.
• Successful Phase 3 studies for Sjögren's syndrome treatment.
• Seeking out-licensing opportunities to accelerate drug candidate development.

Negative

• Dependence on revenues from COVID-19 test kits could pose risks.
• Limited cash and history of losses may affect operations.
• Need for additional capital for ongoing product development.

The FDA gave positive feedback regarding filing a Biologics License Application (BLA) for Sjögren's syndrome following two Phase 3 studies

Ainos is seeking out-licensing opportunities to accelerate the process of bringing five new drug candidates to Phase 3 trials and eventual commercialization

SAN DIEGO, Nov. 3, 2022 /PRNewswire/ -- Ainos, Inc. (NASDAQ: AIMD, AIMDW) ("Ainos", or the "Company"), a diversified medtech company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that it is pursuing out-licensing opportunities for five new drug candidates for its low-dose oral interferon-alpha ("IFNα") formulation, VELDONA^®. Ainos has completed Phase 2 trials for the five new drug candidates and will work with potential partners to accelerate the candidates to Phase 3 trials and eventual commercialization of VELDONA^®. For more information, please visit https://www.ainos.com/.

FDA feedback on the efficacy of the Company's new drug candidate for treating Sjögren's syndrome has been promising following two Phase 3 results.

Ainos' low-dose oral VELDONA^® formulation is designed to enhance a patient's immune response and boost their ability to fight viral infections, while also potentially reducing the side effects and risks caused by high-dose interferons and other small molecule drugs. The following five indications have completed Phase 2 trials and showed positive effects of oral VELDONA^® treatment. Ainos aims to enter out-licensing agreements to advance VELDONA^® to Phase 3 trials and commercialization.

• Sjögren's syndrome (US IND No. 5700): After 48 weeks of treatment, the clinical results showed increased unstimulated whole saliva and improvements in mouth dryness and seven other SS symptoms. The FDA provided promising feedback on the efficacy of this treatment over the course of two Phase 3 results.
• Aphthous Stomatitis (US IND No. 5126): The clinical results showed clearance of existing lesions and reduced severity of new lesions.
• Chemotherapy-induced Stomatitis (US IND No. 5587): The clinical results showed reduced severity during repeat chemotherapy.
• Influenza (Australian ACTRNACTRN12609000976280): The clinical results showed reduced incidence of moderate to severe symptoms; remission of sore throat, fever and head congestion; and significantly reduced influenza-like illness rate in three subgroups: 50 year and older, those vaccinated against seasonal flu, and males.
• Common Cold (US IND No. 5244): The clinical results showed immediate reduction of malaise and sore throat after 6 hours from initial treatment.

The Company's product is delivered into the oral cavity as a lozenge in low (nanogram) doses. Human studies have shown that IFNα given orally is effective against viral and autoimmune diseases, without the side effects associated with high-dose injections of IFNα. Ainos has cumulatively spent nearly $40 million on developments related to the oral use of IFNα (VELDONA^® formulation), not including the expected expenses on clinical trials and manufacturing VELDONA^®. To date, 68 clinical trials have been conducted with low-dose oral IFNα. Sixty-three studies were Phase 2 trials, and three Phase 1 and two Phase 3 studies have also been conducted. Nearly 6,000 patients with one of 16 different disease indications and/or healthy volunteers participated in these trials, including a total of 4,600 subjects exposed to IFNα at a dose level ranging from three to 2,000 international units given daily for up to five years. The safety of orally administered IFNα has been consistently demonstrated in these trials.

Interferons are proteins made by host cells in response to the presence of pathogens such as viruses, bacteria, parasites, or tumor cells. They allow for communication between cells to trigger the protective defenses of the immune system that eradicate pathogens or tumors. Of the nine different families of human interferon that have been identified, interferon-alpha is the most widely studied. The US FDA has approved the use of IFNα in mega doses given by injection for treating a number of cancers, as well as Hepatitis B and C.

Chun-Hsien Tsai, Ainos' Chairman of the Board, President, and Chief Executive Officer, commented, "The Phase 3 results of the new drug candidate for Sjögren's syndrome is an effective demonstration of the potential VELDONA^® treatment holds for other indications. Low-dose oral interferon-alpha treatments have previously shown a promising array of potential applications through Phase 2 clinical trials, and we recently carried out studies that demonstrated VELDONA^®'s effectiveness in protecting against symptoms associated with COVID-19 and prevention and treatment of influenza. By exploring out-licensing opportunities for our five VELDONA^® new drug candidates, we plan to accelerate commercialization of our VELDONA^® technology as rapidly as possible."

About Ainos, Inc.

Headquartered in San Diego, California, Ainos, Inc. (f/k/a Amarillo Biosciences, Inc.) is a diversified medtech company engaged in developing innovative medical technologies for point-of-care testing and safe and novel medical treatment for a broad range of disease indications. In addition to its proprietary therapeutics using low-dose non-injectable interferon, Ainos is committed to developing a comprehensive healthcare business portfolio encompassing medical devices and consumer healthcare products. While prioritizing the commercialization of medical devices as part of its diversification strategy, Ainos has also expanded its product portfolio to include Volatile Organic Compounds (VOC) and COVID-19 POCTs. Leveraging its patents related to VOC technologies and COVID-19 POCT products, the Company seeks to expedite the commercialization of its medical device pipeline, beginning with Ainos-branded COVID-19 POCT product candidates.

Forward-Looking Statements

This press release contains "forward-looking statements" about Ainos within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "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 planned drug treatments announced in this press release; the Company's dependence on revenues from the sale of COVID-19 test kits; 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 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; and the Company's success in managing the growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' most recent Annual Report on Form 10-K/A and other reports filed with the U.S. Securities and Exchange Commission, many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's Form 10-K/A, 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. 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.

Investor Relations Contact
ICR, LLC
Robin Yang
Tel: +1 646-224-6971
Email: Ainos.IR@icrinc.com

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SOURCE Ainos, Inc.

FAQ

What is Ainos, Inc.'s ticker symbol?

Ainos, Inc. trades under the ticker symbol AIMD on NASDAQ.

What positive feedback did Ainos receive from the FDA?

Ainos received positive feedback for its Biologics License Application for treating Sjögren's syndrome following two Phase 3 studies.

How much has Ainos invested in the development of VELDONA®?

Ainos has invested nearly $40 million in the development of its low-dose oral interferon-alpha formulation, VELDONA®.

What are the five new drug candidates Ainos is pursuing?

The five drug candidates include treatments for Sjögren's syndrome, aphthous stomatitis, chemotherapy-induced stomatitis, influenza, and common cold.

What is the goal of Ainos in seeking out-licensing opportunities?

Ainos aims to accelerate the process of bringing its five new drug candidates to Phase 3 trials and commercialization.