Investors

AXIM® Biotechnologies Letter to Shareholders: Oct 2020

Dear Shareholders:

I would like to take this opportunity to provide an update to our valued shareholders on AXIM’s exciting milestones since my previous letter in May of this year and give further insight into our plans for the end of 2020 and beyond. 

As I touched on in my previous letter, AXIM’s acquisition of Sapphire Biotech in late March of this year has allowed us to expand both our research capabilities and focuses to include diagnostics and therapeutic research on cancer. Sapphire’s research team has been able to conduct unprecedented scientific research in a short time, repositioning AXIM’s trajectory as a pharmaceutical innovator. 

Additionally, around the onset of the COVID-19 pandemic, our team had an internal discussion to decide how we could utilize our expertise to create solutions to decrease its spread and to be able to achieve revenue years earlier than traditional early stage biotech companies. Once again, AXIM’s scientific team proved its world-class knowledge by swiftly adapting its research strategy to creating COVID-19 rapid diagnostic tools, including multiple first-in-class COVID-19 neutralizing antibody tests and other innovations. 

COVID-19 Focused Product Development

  • World’s First Rapid Diagnostic Test for Detecting Neutralizing Antibodies
    • Status: Emergency Use Authorization (EUA) filed with the FDA
    • Signed distribution and manufacturing agreement
    • Filed provisional application on May 12, 2020
    • Initiating live virus comparison study at BSL3 lab 
  • NeuCovix-HT™: A high throughput, patent-pending diagnostic test that measures levels of functional antibodies in plasma or serum that neutralize the SARS-CoV-2 (COVID-19) virus
    • Status: EUA filed with the FDA
    • Filed two provisional applications on August 3rd and August 4th regarding a high throughput detection of neutralizing antibodies to SARS-CoV-2
    • Securing materials and optimizing assay
  • World’s First Face Mask Designed to Capture COVID-19 Virus
    • Provisional patent application filed on August 14, 2020, regarding the invention of filtration material capable of blocking or impeding the flow-through of the infectious agent COVID-19 or to support the infectious agent capture moiety
    • Additional testing is ongoing
  • Virus Binding Protein (VBP)
    • Filed a provisional patent application on September 22, 2020, relating to the invention of a VBP that is more potent, has a longer shelf life and is more stable than wild type ACE2
    • In addition to current use in AXIM’s neutralizing antibody tests and face mask, the invention relates to the use of the VBP for the treatment and diagnosis of various disorders.

AXIM’s rapid diagnostic test for detecting neutralizing antibodies is the first of its kind. The test has the ability to deliver results in under 10 minutes and can detect the level of neutralizing antibodies an individual has. We have designed this test to be used at point-of-care facilities to measure levels of neutralizing antibodies in convalescent plasma so that plasma with the highest levels of neutralizing antibodies can be identified and administered to patients fighting COVID-19. Without this knowledge, many patients could be undertreated with non-neutralizing plasma and may not benefit from this treatment. Another application of our point-of-care test is to help ensure that vaccines and monoclonal antibody drugs elicit high levels of neutralizing antibodies. When a vaccine is available, manufacturers can employ AXIM’s rapid point-of-care test to evaluate protective immune responses in vaccine recipients. 

In August of this year, we signed an exclusive licensing, manufacturing and distribution agreement with Empowered Diagnostics LLC to execute the high volume production of our rapid point-of-care diagnostic test. AXIM and Empowered have completed the technology transfer and Empowered Diagnostics has built out their production facility to be able to manufacture millions of our tests per month. As what we believe to be the last step for the EUA application already filed with the FDA for our plasma test we will be conducting a live virus comparison study on 30 plasma samples at a Biosafety Level 3 (BSL3) laboratory.  As soon as this comparison study is finished we will amend the EUA and we expect to begin sales and manufacturing immediately and also expect to see significant revenue shortly thereafter.

We have also received Institutional Review Board approval to begin a clinical study at Arizona State University with our point-of-care whole blood test as the last step in what will be another EUA application.  We hope to be the first FDA-approved rapid point-of-care test for neutralizing antibodies.  

Our high throughput rapid neutralizing antibody test, NeuCovix-HT™, was designed to solve a major issue that COVID-19 researchers are currently facing. NeuCovix-HT™ solves the problem of vaccine and monoclonal antibody drug manufacturers’ requirement in Phase 3 clinical trials to measure neutralizing antibody levels longitudinally in large groups of volunteer recipients using expensive and laborious virus-based assays. Clinical centers participating in the vaccine trials could employ NeuCovix-HT™ tests to measure neutralizing antibodies from vaccine recipients in thousands of plasma samples per day and be able to test all recipients multiple times. 

As more of the population recovers from COVID-19, we believe NeuCovix-HT™ will benefit clinical laboratories running batches of thousands of tests per week to measure levels of neutralizing antibodies in COVID-19 convalescent plasma. NeuCovix-HT™ distinguishes which convalescent plasmas contain low and high levels of neutralizing antibodies so that patients fighting COVID-19 can be treated with plasma from donors with the highest levels of neutralizing antibodies. We are in the process of sourcing materials and optimizing the test and expect to finish in the first quarter of 2021.

As our scientific team was hard at work developing our COVID-19 rapid diagnostic tests and virus-capturing face mask, we were frustrated by the delays and costs caused by lack of supply of a recombinant virus binding protein (VBP) for SARS-CoV-2 that was essential to our testing. To continue our projects as planned and decrease overall costs, AXIM’s talented team decided to make its own VBP that is even more potent than current outsourced options. AXIM’s laboratory tests have proven the RBD spike protein binds with our novel VBP. Initial tests also show that our novel VBP is approximately 10 times more potent and stable than current VBP options on the market. This now in-house development of the core ingredients needed to manufacture strips and masks could potentially lead to additional revenue and allows us to control our supply chain.  We have already manufactured enough VBP for millions of rapid diagnostic tests.

Oncology Research Updates

While our research team has been hard at work on our COVID-19 product development, our oncology research and product development remains a major focus. Our scientists have continued their ongoing investigations into the enzyme Quiescin Sulfhydryl Oxidase 1 (QSOX1), a master regulator of extracellular matrix remodeling, and its overexpression by tumor cells. Overexpression of QSOX1 has been unambiguously linked to promoting tumor invasion and metastasis. 

As many of you know, earlier this year, we signed an agreement with Skysong Innovations, LLC (“SI”) to exclusively license rights to pharmaceutical compositions and methods for the treatment of cancer. SI, the intellectual property management company for Arizona State University (“ASU”), licensed the Patents, Technical Information and Materials (“Technology”) to Sapphire on behalf of ASU and Mayo Clinic.

Sapphire Biotech co-founder, Douglas Lake, PhD, Associate Professor at Arizona State University with an adjunct appointment at Mayo Clinic, discovered that a small molecule called SBI-183 inhibited the enzymatic activity of QSOX1 and as a result suppressed tumor cell invasion in vitro and metastasis of breast tumor cells in vivo. Through its medicinal chemistry efforts Sapphire Biotech scientists have synthesized multiple structural analogs of SBI-183 and unveiled SPX-1009 as our lead compound that demonstrated ten-fold improvement in suppressing invasion and metastasis in several cancer models. 

In August of this year, Sapphire was awarded a $395,880 phase I Small Business Innovation Research (SBIR) grant by the National Cancer Institute (NCI) to continue this research and development of novel small molecules that inhibit the enzymatic activity of QSOX1 based on SBI-183. This success has allowed us to bring on additional staff who are dedicated to the research and development of these analogs. We look forward to updating you all on the success of this research as it continues to progress. 

As we push forward steadfastly with our research, the Company will continue to apply for research grants like this one as a part of our fiscal responsibility and funding strategy. 

Additionally, as we aggressively pursue our product development initiatives, AXIM ensures our competitive advantage by protecting our intellectual property each step of the way. Here is a brief overview of our oncology-related patent portfolio updates since May’s shareholder letter:

QSOX1-Related Inventions

  • New Patent re: SBI-183
    • We were delighted to be notified by the U.S. Patent & Trademark Office of Notice of Allowance on September 17, 2020, of “Anti-Neoplastic Compounds and Methods Targeting QSOX1”. This patent validates the novelty of SBI-183 as an inhibitor of tumor growth, invasion and suppression of metastasis, which is the parent compound for our work with SBI-183 analogs with the end goal of identifying the most potent QSOX1 inhibitors. Claims relate to the treatment of neoplastic cells in a variety of cancers, including myeloma, breast, kidney, and pancreas.
  • Conversion of Provisionals re: SBI-183 Analogs
    • On October 16, 2020, we filed a major patent application converting four pending provisional applications relating to SBI-183 analogs into a utility patent filed under the Patent Cooperation Treaty with the US Patent & Trademark Office. One or more of these analogs have been shown in animal studies to be up to 10 times more potent than the parent compound, SBI-183.

I hope that this provides our shareholders with additional information as to the direction of the company, the significance of some of the announcements we have made, and how we plan to move forward over the coming months on our newly announced COVID-19 program. This is uncharted territory for us, as well as the world, however, I could not be more confident in our scientific research team and AXIM’s ability to change the healthcare landscape. We hope you share our excitement and, as always, appreciate your continued support.

Thank you for being a part of our journey and I’m confident AXIM’s future is very bright. 

Sincerely Yours,

John W. Huemoeller II

Chief Executive Officer

 

FORWARD-LOOKING DISCLAIMER

This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties.

 

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