Dear Shareholders,
2022 was a year of growing inflation, rising interest rates, and broad-based declines in the equity capital markets. Entering 2023, we can see light at the end of the tunnel; the
As we continue our growth path toward becoming a multi-product medtech company, we are sharpening our focus on advancing the commercialization of our product pipeline. Our strategic priorities remain our key VOC POCT and VELDONA technologies, both of which made significant and encouraging progress during 2022.
Uplisting on Nasdaq
First and foremost, we completed our uplisting to the Nasdaq Capital Market and our common stock and warrants began trading under the tickers 'AIMD' and 'AIMDW', respectively, in
Accelerating Growth with a Robust Pipeline
Our two major near-term growth drivers, Ainos Flora and VELDONA, remain on their promising development trajectories, further enhancing our confidence in their monetization potential. Ainos Flora, our leading VOC POCT product candidate, is a non-invasive, telehealth-friendly device for detecting Sexually Transmitted Infections (STIs) and vaginal infections. Unlike traditional STI testing, Flora affords users the privacy and convenience of discreetly testing anywhere and returns results within minutes. As STI rates continue to grow globally, there is still a notable lack of effective at-home STI testing solutions. Ainos Flora addresses this current gap in the market. The product is currently undergoing clinical studies in medical centers in
Our other growth driver is VELDONA, an orally-administered very low-dose interferon alpha treatment. Designed to boost patients' immune systems without the risks and side-effects carried by higher-dose interferon treatments, VELDONA is intended to be more easily administered, more practical to store, less expensive, and requires less physician follow-up than existing treatments. VELDONA has consistently demonstrated its safety and efficacy across 68 clinical trials, including 63 Phase 2 trials and two Phase 3 trials.
We have begun pursuing out-licensing opportunities for drug candidates for five disease areas, including Sjogren's Syndrome, Aphthous Stomatitis, Chemotherapy-induced Stomatitis, Influenza, and Common Cold, with the goal of accelerating the advancement of these candidates to Phase 3 trials and eventual commercialization. We are also planning to initiate Phase 2 trials in
Additionally, recent preclinical data demonstrated VELDONA's potential benefits for two of the most common veterinary diseases, feline chronic gingivostomatitis (FCGS) and canine atopic dermatitis (CAD). We are prioritizing our efforts to commercialize this program as healthcare supplements in applicable countries. Our goal is to begin clinical trials into the formulation's potential veterinary applications by the second quarter of 2023, which, in combination with our development of VELDONA for use in humans, will create a wide range of opportunities for its future commercialization and development.
Investing in the Future
We believe that during the COVID-19 pandemic, consumers have been increasingly familiar with at-home tests. Home self-testing and self-collection have been increasingly available for health areas such as women's health and sexual health. We believe this new user behavior, supported by a variety of telehealth platforms, will become increasingly supportive to our other POCT products as COVID-19 becomes endemic.
Our top medium-term priority is the further development of our VOC POCT technology portfolio. Our AI Nose platform, which combines digital nose sensors, AI algorithms, and our innovative Smell ID technology, opens up significant long-term opportunities for us. We are happy to see that more and more healthcare innovators have introduced VOC-based POCTs for a variety of healthcare purposes.
An important component of our future VOC POCT solutions portfolio is our multi-purpose Ainos Pen breath analyzer. The pen is a non-invasive POCT device that analyzes the user's breath for changes in VOCs. Whereas many breath analysis tools on the market today are manufactured for specific use cases, Ainos Pen can be utilized for a wide variety of different testing scenarios. Our goal for 2023 is to continue to optimize Ainos Pen's performance to expand its long-term potential in the telehealth sector.
We will also continue to build our SRNA platform which is capable of expediting the development of precision treatments and tests. In combination with VELDONA and our VOC POCT, the platform endows us with a synergistic product range of telehealth-enabled precision medicine.
Other Growth Opportunities
Sales of our COVID-19 Antigen Test Kits in
We have recently established several strategic partnerships. Notably, we have entered into an exclusive agreement with the
Debt Settlements and Cash Balance
Following the conversion of our convertible notes and the proceeds from our public offering, we have significantly reduced our debt and strengthened our balance sheet. At the end of the third quarter of 2022, our debt ratio stood at 6.8%, down from 75% at year-end 2021. As of
Ainos' Objectives
We enter 2023 confident and prepared for the promising, albeit challenging, road ahead. As we transform into a multi-product medtech company, we will leverage our competitive advantages and innovative product array to generate value and facilitate stable, high-quality growth. Our strategic partnerships, combined with
Following an exceptionally challenging past year, the determination and diligence of our entire team means that we are well-positioned to continue to pursue our strategic goals during 2023. We stand at the cusp of a new chapter in our company's history, and we will enter it with the innovative, hard-working, and resilient spirit our team has always embraced.
About
Headquartered in
Forward-Looking Statements
This press release contains 'forward-looking statements' about Ainos within the meaning of the safe harbor provisions of the
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
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.
Contact:
Tel: +1 646-224-6971
Email: Ainos.IR@icrinc.com
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