Ainos Pursues Licensing Partners to Accelerate Five Candidates of its Low-dose Oral Interferon Formulation VELDONA to Phase 3 Trials and Commercialization

Rhea-AI Summary

Ainos, Inc. (NASDAQ:AIMD, AIMDW) announced it is pursuing out-licensing opportunities for five new drug candidates of its low-dose oral interferon-alpha formulation, VELDONA. The candidates have successfully completed Phase 2 trials, with plans to accelerate them to Phase 3 and commercialization. The trials demonstrated VELDONA's effectiveness in treating various conditions, including Sjögren's syndrome and influenza. Ainos has invested nearly $40 million in the development of VELDONA and aims to enhance autoimmunity while minimizing side effects compared to high-dose injections.

Positive

• Successful completion of Phase 2 trials for five indications of VELDONA.
• Plans to expedite commercialization through out-licensing opportunities.
• Demonstrated clinical efficacy in treating conditions like Sjögren's syndrome and influenza.

Negative

• Ainos has incurred nearly $40 million in development costs without guaranteed success in later trial phases.
• Dependence on future licensing and commercialization success to generate revenue.

Clinical results thus far have shown low-dose oral interferon's promising efficacy as a new treatment or as an alternative to high-dose injectable interferon

SAN DIEGO, CA / ACCESSWIRE / October 31, 2022 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ: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/.

The following five indications have completed Phase 2 trials. Ainos aims to enter out-licensing agreements to advance VELDONA® to Phase 3 trials and commercialization.

• Sjögren's syndrome (US IND No. 5700)
• Aphthous Stomatitis (US IND No. 5126)
• Chemotherapy-induced Stomatitis (US IND No. 5587)
• Influenza (Australian ACTRNACTRN12609000976280)
• Common Cold (US IND No. 5244)

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.

Ainos's low-dose oral VELDONA® formulation is designed to enhance autoimmunity to resist virus damage, potentially reducing side effects and risks caused by high-dose interferon and other small molecule drugs.

Positive effects of oral VELDONA® treatment have been noted across a wide range of disease indications, including:

• In Sjögren's syndrome (SS) (US IND No. 5700), after 48 weeks of treatment the clinical results showed increased unstimulated whole saliva and improvement in mouth dryness and seven other SS symptoms.
• In Aphthous Stomatitis (US IND No. 5126), the clinical results showed clearance of existing lesions and reduced severity of new lesions.
• In Chemotherapy-induced Stomatitis (US IND No. 5587), the clinical results showed reduced severity during repeat chemotherapy.
• In 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.
• In Common Cold (US IND No. 5244), the clinical results showed immediate reduction of malaise and sore throat after 6 hours from initial treatment.

Chun-Hsien Tsai, Ainos' Chairman of the Board, President, and Chief Executive Officer, commented, "Low-dose oral interferon-alpha treatments have shown a promising array of potential applications through Phase 2 clinical trials. We have recently carried out studies that demonstrate 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

SOURCE: Ainos, Inc.

View source version on accesswire.com:
https://www.accesswire.com/723028/Ainos-Pursues-Licensing-Partners-to-Accelerate-Five-Candidates-of-its-Low-dose-Oral-Interferon-Formulation-VELDONA-to-Phase-3-Trials-and-Commercialization

FAQ

What are the five drug candidates Ainos is pursuing with VELDONA?

The five drug candidates are for Sjögren's syndrome, Aphthous Stomatitis, Chemotherapy-induced Stomatitis, Influenza, and Common Cold.

What were the results of the Phase 2 trials for Ainos's VELDONA?

The Phase 2 trials showed positive effects, including increased saliva production in Sjögren's syndrome and reduced influenza symptoms.

When does Ainos plan to advance VELDONA to Phase 3 trials?

Ainos is currently seeking out-licensing partners to accelerate VELDONA to Phase 3 trials.

How much has Ainos invested in the development of VELDONA?

Ainos has invested nearly $40 million in the development of its oral interferon formulation, VELDONA.

What is the purpose of Ainos's low-dose oral interferon-alpha formulation?

The formulation aims to enhance autoimmunity and reduce side effects associated with high-dose interferon treatments.