Summary:
- AXIM places strategic focus on commercializing FDA-cleared Dry Eye Disease (DED) diagnostic system
- Plans to address largely underserved DED diagnosis market with patent pending tear collection method and approved tests, supported by world-class DED management team
- Supply agreements in place to fulfill demand for DED readers and test strips, creating large revenue opportunity
- Plans to submit a Phase II grant to further oncological program
- Company places emphasis on generating positive cash flow through DED program
SAN DIEGO, April 19, 2022 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM® Biotech,” “AXIM” or “the Company”), an international healthcare solutions company targeting dry eye disease (DED), announced today that it has issued the following letter to its shareholders providing commentary on the Company’s recent announcements and upcoming plans.
Dear Shareholders:
It is with great enthusiasm that I write to you all today. In this letter, I hope to provide further context into some of our research and operational milestones over the last few months and more importantly, highlight the unique opportunity we have before us in addressing healthcare's largest diagnostics gaps, which affects millions of people worldwide.
In recent months, we have been working diligently to further position AXIM for both immediate and long-term success. As most of our shareholders know, since our acquisition of Sapphire Biotech and with the onset of the COVID-19 pandemic, we have been focused on three key areas specific to the diagnostic area; oncological, COVID-19, and most recently, dry eye disease (DED). Each of these provide strong upside potential for AXIM; however, each comes with its own set of regulatory and scientific hurdles that we must overcome. While we remain optimistic about each program, I believe it to be of the utmost importance to focus the most time and resources on the program with the ultimate potential for success, in the nearest term. While that does not mean we will abandon these other programs, we simply cannot wait on the painstaking slow regulatory approvals needed to generate the revenue required to further our mission and unlock shareholder value. As such, following an extensive analysis by our management team, board of directors, and expert consultants with an objective perspective, the Board determined our best path forward lies with DED. The DED initiative is an extremely large opportunity for our Company and has been gaining strong momentum in recent months. We believe it offers the most potential for rapid and immediate growth, which could lead to ultimate profitability for the organization, which would no doubt enhance shareholder value.
Touching on that momentum, I’m delighted to share that our DED diagnostic initiatives are already ahead of plan. Since the third quarter of 2021, we have acquired substantial assets, including already approved diagnostic tests, which complement the research we have been conducting to-date, as well as appointed several nationally acclaimed senior experts with whom to build our DED business. Despite DED being the most common ocular surface disorder, affecting approximately 350 million people worldwide – causing persistent eye irritation, blurred vision, pain and decreased quality of life -- the sector has seen little innovation. There remains a desperate demand for better DED testing and diagnosis, especially at the point-of-care, and we believe we are well positioned to dominate this marketplace, while we actively work to develop and bring to market new solutions enabling us to offer comprehensive state-of-the-art DED solutions.
Our next-generation solutions are unique in that they offer patients not only a fast and reliable answer as to why they are suffering, but offer a solution to physicians who are looking to help patients suffering from this overly common disease. We have spoken with so many physicians who are extremely interested in our diagnostic system, which creates not only a one-time revenue influx for AXIM, but an on-going revenue stream generated from the purchasing of testing strips. These readers and test strips are now ready, the science is proven and they are approved for sale. That is the opportunity for AXIM – to dominate this underserved market – in the immediate term. I could not be more excited about our prospects and expect sales to begin in the coming weeks.
Covid Neutralizing Antibodies and QSOX1 Cancer Therapy
Over the past two years, as COVID ravaged the world, our scientific team proved its world-class scientific acumen by swiftly developing first-in class COVID-19 neutralizing antibody tests. Shortly after its development, we filed for Emergency Use Authorization with the Food and Drug Administration (FDA), signed a distribution and manufacturing agreement, initiated live virus comparison studies, and filed several patent applications on the diagnostic tools. We waited in anticipation that the FDA would move quickly given the nature of the pandemic; however, we were disappointed week after week until we finally received a response a short time ago that the FDA had changed its guidance to only focus on quantitative tests and that they were denying our application. This was unfortunate especially given our firm belief in its efficacy and potential to assist in the global fight against this virus. In the last few weeks, we have adjusted our strategy to offer the rapid point-of-care test For Research Use Only to try and capture some revenue while we look for another partner to do the heavy lifting of running a new clinical study and resubmitting the EUA application. That said, we are fearful that the U.S. government’s drive to approve such solutions is fading, and that it is unlikely to grant an EUA to ours or similar tests, although it is still a possibility since this virus is likely going to be around for a long time. However, it is this realism that further illustrated to me and the board our need for a readjustment of our focus on the DED program.
In terms of our oncological diagnostic program, our scientists have been diligently investigating the enzyme Quiescin Sulfhydryl Oxidase 1 (QSOX1), a master regulator of extracellular matrix remodeling and its overexpression by cancerous tumor cells that is clearly linked to promoting tumor invasion and metastasis. This discovery led us down three paths; one in the development of a diagnostics, point-of-care tool which would measure QSOX levels, leading to pre diagnosis of cancer; another being our identification and the licensing of SBI-183, a compound that showed promise as a cancer treatment given its QSOX1 suppressing properties and the last being that we were awarded a $395,880 phase I Small Business Innovation Research (SBIR) grant by the National Cancer Institute (NCI) to continue research and development of novel small molecules that inhibit the enzymatic activity of QSOX1 based on SBI-183. Given the success in the development of analogs to SBI-183, it is the Company’s intent to submit a phase II grant in the amount of $1,500,000 before the deadline in December.
All said, I am immensely proud of our scientific team and the progress they achieved – which we strongly believe still holds scientific value for those sectors. We are continuing to evaluate opportunities that hold the largest upside value for the company including the options to license those assets to a suitable biopharma company.
Focus on the DED Market for Financial Performance and Shareholder Value
Now to turn to the “why” DED and the rationale behind our strategic focus on it. According to the American Academy of Ophthalmology, approximately 20 million people in the US have DED. That number is growing in both young and old adults, making it imperative that clinicians determine how to best diagnose and treat it.
Diagnosing DED is a particular challenge because of the multifactorial nature of the disease, with symptoms similar to other ocular surface conditions. There is often discordance between signs and symptoms, highlighting the need for more sensitive and accurate diagnostic tools. Figures from the American Journal of Ophthalmology corroborate this. As of July 2017, an estimated six million people reported DED symptoms without receiving a diagnosis.
The DED marketplace is massive, with analysts projecting the global market to grow at a CAGR of 6.6% from 2021 to 2026 and reach $6.1 billion by 2024.
Accordingly, in mid-2021, we started building the infrastructure and foundation needed to engage this large and dynamic market successfully. Our cutting-edge, next-generation solutions provide AXIM with far higher prospects of predictable growing revenue and earnings power.
On August 26, 2021, we signed an agreement to acquire two FDA-cleared 510(k)’s DED diagnostic testing technologies. The tests are part of a highly specialized point-of-care (POC) lab testing system explicitly designed to assist eyecare physicians in detecting and quantifying various biomarkers associated with external ocular disorders. The tests are also approved for insurance and Medicare reimbursement.
Both these tests are non-invasive, Rapid Lateral Flow Assays using tears:
The first is a rapid (10-minute) lateral flow diagnostic assay that tests for exact levels of lactoferrin through the collection of 0.5 microliter in tears. The benefits of testing lactoferrin Levels in the tear film include:
- Low Lactoferrin levels directly correlate to DED caused by aqueous deficiency
- The severity of DED can be determined by the Lactoferrin level
- Low Lactoferrin levels may represent increased surgical risk or contact lens intolerance
- Changes in Lactoferrin levels may show the efficacy of the prescribed treatment
The second test is for the measurement of Ocular Immunoglobulin E (IgE), a biomarker for allergies and a key biomarker primarily associated with Dry Eye Disease. The benefits of Testing IgE Levels in the Tear Film include:
- The presence of IgE indicates the diagnosis of allergic conjunctivitis
- Levels of IgE increase with the severity of the allergic response
- IgE testing can help differentiate allergic conjunctivitis from dry eye syndrome
- Allergic conjunctivitis is a contraindication for LASIK and other surgical procedures
On March 8, 2022, we announced that we had successfully developed what we believe to be the first-ever rapid quantitative tear test for MMP-9, an inflammatory biomarker for DED. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients. The central role of inflammation in OSD is widely recognized, but the ability to measure this in the clinic has been limited to the Quidel InflammaDry test, which provides a positive/negative result. This “yes or no” report has clinical value, but it is limited.
The clinical benefits of our quantitative tear MMP-9 testing are a significant advance in the ability to measure the degree of inflammation affecting dry eye patients, allowing for more objective classification of their disease. Equally important would be the ability to measure improvement in control of inflammation that is the goal of many therapies for OSD, including pharmaceuticals, thermal pulsation treatments and even light based therapies.
DED Top-Tier Management and Expertise
Furthermore and as I mentioned, we have quickly built a world-class DED Medical Advisory Board consisting primarily of DED ophthalmology and optometry experts in support of our aggressive execution of our DED business strategy. Those appointments include:
- Ophthalmic industry veteran Jeff Busby as our Senior VP Business Development.
- Joseph Tauber, MD, to Chief Medical Officer and Chairman of our Medical Advisory Board. With a Harvard grad pedigree, he brings 30 years of clinical experience. Over the past 25 years, he has had deep involvement in virtually every significant dry eye development project. He has served as a Principal Investigator in over 140 multicenter clinical trials, including those of all four FDA-approved dry eye treatments– Restasis, Xiidra, Cequa and Eyesuvis.
Of the US’ 7,800 ophthalmologists, Dr. Tauber is arguably one of the nation’s top doctors specializing in DED. (While space limitations prohibit including the full bios of our stellar – and diverse -- Medical Advisory Board, I invite you to click through and view their extraordinary credentials.) - Senior DED expert Dr. Laura Periman. She brings 30 years of experience in medicine, the last 20 of which include her clinical practice specializing in ocular surface disease and (DED).
- Kelly K. Nichols, O.D., M.P.H., Ph.D. is a highly respected and educated optometrist and a founding member of the Ocular Surface Society of Optometry. She serves as Dean of the School of Optometry at The University of Alabama at Birmingham, is an acknowledged expert on DED and Ocular Surface Disease and has been extensively published.
Optometrists are on the front lines of America’s eye healthcare, and Dr. Nichols will be instrumental in helping shape our marketing communications strategy to the nation’s roughly 36,000 optometrists. - Dr. Michael E. Stern. Dr. Stern is Principal and Chief Science Officer for immunEyze, a boutique contract research organization that performs preclinical and clinical research for OSD indications. Previously, he served for 26 years with Allergan where he rose to Principal Scientist and Vice-President Inflammation Research whose work included elucidating the pathophysiology of DED. He is extensively published in leading ocular journals.
- Veteran Lab Testing Executive Barry Craig as a key Company consultant. Mr. Craig will manage and navigate our DED lab testing, compliance, and field-testing processes. He brings more than 25 years of experience in the clinical laboratory as a generalist, QA Coordinator, and Microbiology Supervisor. He has successfully established more than 200 moderate and high complexity laboratories.
Key Diagnostic Device Supply Agreement
Earlier this month, we completed a key supply agreement for DED test strip readers which will be deployed for diagnostic testing, focusing on lactoferrin levels. The readers, a point of care medical device, will be supplied by Barcelona, Spain-based IUL SA (“IUL”). We will be utilizing state-of-the-art portable iPeak readers that were tested against six other comparable products. These readers are designed to hold different cassette sizes and are equipped with connectivity and can read cassettes of up to five strips and seven lines per strip at a time. iPeak is equipped with “Flash Eye” technology based on the principles of machine vision illumination.
Our diagnostic testing process for DED, and specifically for lactoferrin levels as a primary indicator, will include the use of reagent strip samples. The new readers were recently calibrated with the new test strips and will soon be distributed to our Medical Advisory Board for non-clinical field testing on their patients, including studying the accuracy and ease of use.
We are also in the process of developing additional biomarker tests that will be done on the existing platform, without the constant need of the clinician to upgrade to a newer platform. The Lateral Flow test reader is software-driven and can be programmed to interpret other biomarkers as they are clinically studied and FDA approved. The test uses 0.5 microliters of human tear fluid that is applied to a disposable lateral flow cassette (one cassette per patient tested). The disposable single use cassette generates a substantial, recurring revenue stream for our eye business and our stakeholders.
CLIA Waiver Process
In addition to the field tests conducted by the Medical Advisory Board, we will also be conducting a comparative clinical study. The objective will be to determine whether the AXIM Eye test system has equal or better simplicity than the other forms of diagnostic testing for DED. This study is a key component of our filing process with the FDA for a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver. We will be targeting a waiver for lactoferrin level testing that is expected to prove that the product is simple to use with minimal risks of erroneous results. The expected timeline for filing and a final CLIA decision is approximately three to six months.
Patented Tear Collection System
Tear fluid analysis contributes to the greater understanding of various ocular and systemic diseases. AXIM is developing and patented a novel tear sample collector system that is extremely cost-effective to produce on a mass scale. It is soft, non-intimidating, and easy to use by untrained personnel. It features a simple indicator that appears on the strip when enough tear fluid has been absorbed.
AXIM 2022: Goals and Targeting Positive Cash Flow
While it’s early in 2022, our DED business strategy is starting to take off. Looking ahead, for the remainder of this year, we plan to:
- Appoint additional experts and accomplished executives to our management team.
- Successfully complete our clinical trials to prove the accuracy and ease of use.
- Generate positive, peer reviewed reviews by eye care professionals as to the performance and ease of use.
- Evaluate other next-generation DED treatments that may include oral or topical therapeutics. We have one in our cross-sights and, when ready, plan to commence clinical research with a leading university to prove safety and efficacy. If it works out as expected, we plan to pursue a license or business combination.
- Penetrate the ophthalmologist and optometrist marketplace with our industry-changing DED diagnostic technology.
- Identify strategic acquisition targets to accelerate our DED diagnostic and therapeutic applications and capabilities expansion.
- Grow our DED business to reach a positive cash flow run rate by the end of 2022 and build its profitability in 2023 and beyond.
With all of this preparation and positioning, AXIM is closer than ever to commercializing a healthcare solution that holds the potential to truly revolutionize the world. We have the technology in our asset portfolio, and with more under active evaluation, and I am more than confident that our strategy of penetrating a market where DED impacts over 350 million people will enable our business to grow revenues and increase our earnings power to enhance shareholder value. Ultimately, AXIM is all about the patients whose lives and wellness we can improve in this highly specialized, unmet need area. While it has been a long ride, I can confidently share that I believe we are more well-positioned than ever to capitalize on the opportunity before us.
Thank you for your continued support as we look to change the healthcare landscape, through revolutionary solutions, in the immediate term.
Sincerely Yours,
John W. Huemoeller II
Chief Executive Officer
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 COVID 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
Public Relations
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CMW Media
P. 858-264-6600
kathryn@cmwmedia.com
AXIM Corporate
6191 Cornerstone Ct., Ste. 114
San Diego, CA 92121, USA
P. 858-923-4422
Investor Relations
investors@aximbiotech.com
888-759-0844
