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Summary:
• In 2022, AXIM® finalized optimization of its R&D and manufacturing infrastructure to be used in its diagnostic program
• AXIM will continue to generate revenue from its two FDA-cleared dry eye disease (DED) diagnostic tests through commercialization partner Verséa Ophthalmics
• AXIM anticipates its business to be cash-flow positive in the second half of 2023
• The Company will place a new strategic focus on custom development of new diagnostic solutions for healthcare clients in a variety of fields
• AXIM looks to file for a CLIA waiver for both its FDA-cleared tests in the first quarter, which would significantly increase the market opportunity for sales of its tests
• AXIM looks to conduct a clinical study on its MMP-9 test with hopes of submitting it for a FDA 510(k) clearance
• CEO will host conference call with investors on January 11, 2023, at 5pm Eastern Standard Time
San Diego, CA – 
Dear Shareholders:
It is my pleasure to write to you today with some updates that we are excited to share on AXIM’s progression in becoming a preeminent leader in the diagnostic solutions category. Last year represented one of the most pivotal years for AXIM to date. We generated our first meaningful revenue from our proprietary diagnostic solution platforms for the field of ophthalmology, we partnered with some of the world’s fastest-growing healthcare companies and developed multiple new diagnostic products and prototypes to add to our existing portfolio of three FDA-cleared tests. There is no doubt that AXIM has momentum in its favor and our opportunity has never been greater.
Since focusing our research on the diagnostic solutions space a few years back, we have been dedicated to developing diagnostic solutions for unmet healthcare needs that have the highest possibility of creating meaningful revenue as quickly as possible. Leveraging our world-class science team, we focused our efforts on the area of ophthalmological conditions, specifically dry eye disease (DED). As we have stated, approximately 20 million people in the US have been diagnosed with DED and over 344 million globally; however, that number is expected to be significantly lower than the actual number of patients suffering from the condition due to a lack of accessible and accurate testing. This is the problem AXIM is seeking to address. Our currently available FDA-cleared screening tests, one which measures levels of Lactoferrin and another that measures Immunoglobulin E (IgE), represent a breakthrough in the field of ophthalmological diagnostics in that they are quantitative and fast (both tests render results in 8 minutes), administered and read at the point-of-care, and require 70% less tear sample than other tests on the market. These benefits have been well-received by clinicians across the country and truly set AXIM’s products apart.
As we announced in September, we signed an exclusive agreement with Verséa Ophthalmics to commercialize our two tests. I am happy to report that they have been outstanding in generating interest and orders for our innovative solutions. Earlier last year, we had to make the choice between building our own sales and marketing team in order to commercialize our solutions, or partner with a company such as Verséa who had a proven track record of success in that area, and we eventually decided on the latter. Since signing, Verséa has gone above and beyond in terms of expanding sales of the tests, from attending trade shows to participating in media interviews with outlets specific to ophthalmology, and we are just starting to see the fruits of those labors bear reward in terms of revenue generation. I personally believe working with Verséa has been a great decision and in fact, we are in further talks with Verséa about how to not only increase sales of our two existing tests, but to potentially start development of other tools that they could add to their product offering portfolio in the coming months.
At this point, there is another opportunity for AXIM that I want to highlight. While building the infrastructure team and processes necessary to develop world-class diagnostic tools is time consuming, we now have a vertically integrated diagnostic enterprise that is capable of both research and development and manufacturing of diagnostic solutions of almost any type. In that lies a massive opportunity. We have recently entered into discussions with multiple other healthcare companies on the potential development of new diagnostic solutions, specifically designed to meet their needs. For example, if a company needs a diagnostic tool that measures levels of biomarkers or proteins in patients in order to test the efficacy of a therapeutic during the clinical research and development phase, AXIM’s renowned team of scientists and clinicians can design, test and produce custom tests to meet the needs of the consumer – in a fast and efficient manner. This ability represents a large and untapped revenue generation opportunity for AXIM and one we will be focused on in the coming months.
Additionally, in the first quarter of 2023 we intend to run a useability study that would allow us to file for a CLIA waiver on both of our FDA-cleared tests. When we receive the waiver as expected, the number of potential customers for our tests would skyrocket. We have already written the protocol for the study which will run at three different locations, which we expect to take place in February.
Furthermore, we are working on a clinical study protocol for our highly anticipated MMP-9 test. Uniquely and as a part of our initial agreement, Verséa has agreed to assist in funding the study, further illustrating their excitement and confidence in AXIM’s diagnostic platform. After the study is completed, we expect to file for another 510(k) FDA-clearance on the test, targeting completion in the second quarter of this year. Once approved, we have already agreed to commercializing the product through Verséa, meaning we will begin selling it almost immediately. This new test will be a first-of-its -kind and we anticipate adoption in the medical community to be swift and strong.
I am extremely proud to state that as of today, AXIM Biotech is a revenue generating diagnostic solutions company, with a strong clinical presence, and a robust pipeline of new and exciting solutions in development. This has been our goal for many years – and it has finally become a reality. We are now hyper-focused on increasing revenue from these commercialized products, with the goal of generating enough to fund our future development projects, something uniquely rare in the world of healthcare, especially for smaller firms. Our team has never been stronger and our positioning never better. While market conditions have affected us and many others in a broad sense, we believe this to not be representative of the value we are building. In fact, some of our most legacy and valued long-term investors continue to make investments into our company and share the vision of what we are building. I am confident that if we continue to capitalize on our opportunity, building a strong and solid healthcare company, the market will eventually adjust its sentiment toward the positive.
In closing, I want to personally thank each and every one of our shareholders for their continued support of AXIM. We would not have been able to achieve what we have this last year without you all. In an effort to further communicate with our current and potential shareholders in a transparent and honest manner, we will be hosting a conference call on January 11, 2023 at 5pm Eastern Standard Time to address any questions and provide even further transparency and commentary on our operations. We ask that you share your questions ahead of time by emailing axim@cmwmedia.comand we will try to get to as many as possible. To participate in the call, you can register here: https://us02web.zoom.us/webinar/register/WN_ESckzYZVSPqDQ4Fuv_IQ1g
It continues to be my great honor to work on behalf of you all and look forward to continuing to communicate with all of our valued shareholders as we continue our work in building a global diagnostic solutions company in 2023 and beyond.
Optimistically and respectfully yours,
John W. Huemoeller II, Chief Executive Officer of AXIM® Biotech.
For more information on AXIM’s diagnostic solutions or to speak with some at Verséa about adding these innovative solutions to your clinic, please visit: https://www.versea.com/divisions/ophthalmics/
About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for the diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. The Company owns two of the only five FDA Cleared Diagnostic tests for Dye Eye Disease. For more information, please visit www.AXIMBiotech.com.
Forward-Looking Statements
The statements made by Axim Biotechnologies Inc., in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Axim’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Axim Biotechnologies, Inc. Actual results could differ materially from those projected due to there being no assurance that our diagnostic candidate will ever be approved for use by the U.S. FDA or any equivalent foreign regulatory agency. Further, Axim’s eye care diagnostic products that are FDA cleared may not be manufactured in large enough quantities or that third parties with established eye care physicians will enter into agreements or purchase from the Company, and even if the Company’s diagnostic candidates are successful, they may generate only limited revenue and profits for the Company. Various other factors are detailed from time to time in Axim’s SEC reports and filings, including our Annual Report on Form 10-K filed on April 15, 2022, and other reports we file with the SEC, which are available at www.sec.gov. Axim Biotechnologies, Inc., undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
CONTACT
Kyle Porter
CMW Media
P. 858-221-8001
AXIM Corporate
6191 Cornerstone Ct., Ste. 114
San Diego, CA 92121, USA
P. 858-923-4422
Investor Relations
888-759-0844
View the original release on www.newmediawire.com
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