AXIM BIOTECHNOLOGIES, INC. WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other
information required by the Securities Exchange Act of 1934, as amended (the
"Exchange Act"), with the
On our Internet website, http://www.aximbiotech.com, we post the following
recent filings as soon as reasonably practicable after they are electronically
filed with or furnished to the
When we use the terms "AXIM", "Company", "we", "our" and "us" we mean
FORWARD LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, the other reports, statements, and
information that the Company has previously filed with or furnished to, or that
we may subsequently file with or furnish to, the
Information regarding market and industry statistics contained in this report is included based on information available to us that we believe is accurate. It is generally based on industry and other publications that are not produced for purposes of securities offerings or economic analysis. Forecasts and other forward-looking information obtained from these sources are subject to the same qualifications and the additional uncertainties accompanying any estimates of future market size, revenue and market acceptance of products and services. We do not undertake any obligation to publicly update any forward-looking statements. As a result, investors should not place undue reliance on these forward-looking statements.
Overview
Acquisition of
On
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Current Operations Following the Acquisition of
Oncology
We continue to advance our mission of improving global cancer care through the
development of novel therapeutics for controlling metastatic cancer spread, and
diagnostics for early cancer detection, response to treatment, and for
monitoring post-treatment recurrence. We have made significant progress with the
development of additional anologs of SBI-183 licensed from
We have been investigating 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. One of the Company's co-founders,
The Company believes that its therapeutic drug development strategy targeting the metastatic spread is a unique, novel and pioneering approach to saving lives. The near-term objective of the Company is to demonstrate the ability of its lead anti-QSOX1 drug candidates to suppress tumor growth and metastasis and to advance them into pre-clinical studies.
Additionally, the Company believes that QSOX1 has a significant potential to be developed into an important biomarker for liquid biopsy cancer test. The Company anticipates that ongoing diagnostic product development in 2020 will result in a commercial prototype in early 2021 of a universal companion diagnostic to measure the efficacy of any ongoing cancer treatments based on measuring QSOX1 levels. Ultimately, the Company aims to develop a blood test that makes possible the early detection of cancer.
Covid-19
With the onset of the COVID-19 pandemic, we began creating COVID-19 rapid diagnostic tools, including multiple first-in-class COVID-19 neutralizing antibody tests and other innovations. 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.
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 recipient's 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 derive additional revenue and allows us to control our supply chain. We have already manufactured enough VBP for millions of rapid diagnostic tests.
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In August, we signed an exclusive licensing, manufacturing and distribution
agreement with
We have also received
Milestones 2020 to Date
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Anticipated Expenses
During the next twelve months we anticipate incurring costs related to: (i) filing Exchange Act reports, (ii) contractual obligations, (iii) clinical trials, and (iv) continued research and development.
Intellectual Property I. QSOX1-RELATED INVENTIONS.
QSOX1 (Quiescin Sulfhydryl Oxidase 1) is an enzyme that is over-expressed in multiple tumor types. Genetically silencing QSOX1 in tumors slows their growth, migration, invasion and metastasis. Based on these findings, the inventors of the inventions described below tested libraries of chemical compounds for the ability to inhibit QSOX1. Several inhibitors of the QSOX1 enzyme were identified. Initially, SBI-183 was identified and animal studies confirmed its ability to suppress tumor growth. The inventors subsequently developed an entire library of analogs of the parent compound, SBI-183, detailed in several inventions below to identify compounds with greater inhibitory activity. These compounds have the potential to be developed into therapeutic treatments for metastasis and to be used in conjunction with other neoplastic treatments, such as chemotherapy.
Included in the group of QSOX1-related inventions below is the identification of a specific splice variant of QSOX1, identified as QSOX1-L, as a unique Biomarker for the detection of certain tumors overexpressing QSOX1. This biomarker formed the basis for the invention relating to a Rapid Diagnostic Test for certain cancers.
A. Anti-Neoplastic Compounds and Methods Targeting QSOX1
1.US Provisional Patent Application No. 62/218.732 filed on
PCT Provisional Patent Application W02017048712A1
US Nonprovisional Application No. 15/748,784 filed on
Notice of Patent Allowance dated
Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1
Assignee:
Exclusive Licensee:
Compounds and methods involving inhibition of the enzymatic activity of QSOX1. The compounds and methods can be used in treatment of neoplastic cells to suppress tumor growth and invasion in a variety of cancers, including but not limited to myeloma and cancers of the breast, kidney and pancreas. Claims include the compound SBI-183 as a neoplastic agent found to inhibit tumor growth, invasion and suppress metastasis of tumors by inactivating QSOX1.
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2.US Provisional Patent Application No. 62/916,065 filed on
Title: Chemical Compounds that Inhibit QSOX1 for the Treatment of Cancer
Assignees:
Derivatives of the parent compound SBI-183 have been identified as inhibiting the enzymatic activity of QSOX1. These compounds can be used in treatment of neoplastic cells by suppressing tumor growth and invasion in a variety of cancers that overexpress QSOX1, including but not limited to myeloma and cancers of the breast, kidney and pancreas.
3.US Provisional Patent Application No. 62/916,067 filed
Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1
Assignees:
Exclusive Licensee:
Compounds that are structurally distinguishable from the compound, SBI-183 are SPX-013 and SPX-014, and have been identified as inhibiting the enzymatic activity of QSOX1. The compounds and methods can be used in treatment of neoplastic cells by suppressing tumor growth and invasion in a variety of cancers, including but not limited to myeloma and cancers of the breast, kidney and pancreas.
4.US Provisional Patent Application No. 62/944/283 filed
Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1
Assignees:
Exclusive Licensee:
Compounds that are structurally distinguishable from the SBI-183 have been identified as inhibiting the enzymatic activity of QSOX1. One in particular, SPX-1009, also inhibits tumor cell growth, migration and invasion in vitro and metastasis in a mouse model of triple negative breast cancer. This invention concerns analogs of this lead compound SPX-1009. In in vitro testing, the lead compound SPX-1009 and its analogs have been found to be more potent and to have improved pharmacodynamics in mouse models of cancer.
5.US Provisional Patent Application No. 62959752 filed
Title: Anti-Neoplastic Compounds and Methods Targeting QSOX1 and Inhibiting Cellular Responses to MET Receptor.
Assignee:
Compounds and methods involving inhibition of the enzymatic activity of QSOX1 and methods of inhibiting cellular responses to the MET receptor signaling are disclosed which include administering any one or more compounds or pharmaceutical compositions. The compounds and methods can be used in treatment of neoplastic cells, for example, to suppress tumor growth and invasion in a variety of cancers, including but not limited to myeloma and cancers of the breast, kidney and pancreas. The uniqueness of the invention relates to the combined inhibition of QSOX1 and cellular responses to the MET receptor signaling.
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B. Unique Biomarker QSOX1-L Identified and Rapid Diagnostic for Various Cancers
1.US Provisional Patent Application No. 62/829,556 filed
Utility Patent Application No. 16/841,521 filed
International Patent Application No. PCT/US2020/026936 filed
Title: Systems and Methods for Rapid Diagnostic for Various Cancers
Assignee:
QSOX1-L, a splice variant of QSOX1, has been identified as a novel biomarker of bladder cancer and possibly other cancers in serum. Proprietary antibodies have been generated that selectively detect only this variant and not others. QSOX1-L has been used to develop a rapid and cost-effective diagnostic test for bladder and possibly other urologic cancers from urine.
II. SARS-CoV-2-RELATED INVENTIONS
A. Rapid Diagnostic Test to Measure Levels of Neutralizing Antibodies to SARS-CoV2
1.US Provisional Application No. 63/023,646 filed
Title: Convalescent Plasma Testing and Treatment
Assignee:
Exclusive Licensee:
The invention refers to a Rapid Test to measure levels of Neutralizing Antibodies to SARS-CoV2. Unlike currently available serological COVID-19 tests that detect an antibody response to the virus, the rapid 10-minute test measures a specific subpopulation of antibodies that block binding of the virus to host cell receptors. In contrast to current tests using live viruses which are time-consuming, expensive and require trained personnel in a tightly controlled laboratory setting to measure neutralizing antibodies, the rapid test is a portable, low cost, rapid point- of-care test that measures levels of neutralizing antibodies in 10 minutes.
2. US Provisional Application No. 63/144,454 Filed
Title: Rapid LFA Diagnostic Test to Measure Levels of Neutralizing Antibodies to SARS- CoV-2 from Whole Blood
Assignee:
Exclusive Licensee:
The invention methods and test kits can be used with any sample in which the presence, absence and/or quantity of neutralizing antibodies (nAbs) to SARS-CoV-2 is desired to be determined, such as for example, serum, plasma, whole blood, saliva, mucous, and other biological fluids. In a particular embodiment, the invention methods and/or kits are used with whole blood.
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B. AlphaLisa Assay for High Throughput Detection of Neutralizing Antibodies to SARS-CoV2
1.US Provisional Application No. 63/060,635 filed
Title: NeuCovix-HT AlphaLisa assay for high throughput detection of Neutralizing Antibodies to SARS-CoV-2
Assignee:
Exclusive Licensee:
The invention refers to an AlphaLisa assay for high throughput (HT) detection of Neutralizing antibodies to SARS-CoV-2. Included in the claims is the HT diagnostic test that measures levels of functional antibodies in plasma or serum that neutralize SARS- CoV-2, the virus that causes COVID19. Unlike current serology tests for COVID 19 that qualitatively detect antibodies to the virus, the HT test quantitatively measures functional antibodies that block binding of the virus to host cell receptors.
C. Direct Competitive ELISA for the Detection of SARS-Cov2 Neutralizing Antibodies
1.US Provisional Application No. 63/152,807 filed
Title: Direct Competitive ELISA for the Detection of SARS-CoV2 Neutralizing Antibodies
Assignee:
The invention relates to a method for rapid detection of SARS-CoV2 Neutralizing Antibodies in one of the following test samples: human or animal serum, plasma, saliva, tear, sweat, exhaled breath condensate. The test sample is mixed with an ACE2 label detection reagent. The sample mixture is incubated, and the quantity of ACE2 label detection reagent bound to the RBD molecules indicates the quantity of SARs-Co2 Neutralizing Antibodies.
D.ACE2 Variants
1.US Provisional Application No. 63/081,811 filed
Title: Super-ACE2 Variants
Assignee:
The invention relates to a new variant recombinant protein of ACE2 identified as ACE2-614-Fc ("Super ACE2"), that is more potent and has a longer shelf life and is more stable than wild type ACE2. Super ACE2 variant can be used in a variety of ways as follows:
1)Development of competitive assays for neutralizing antibodies that disrupt RBD- ACE2 interaction.
2)Direct assays for virus spike antigens. Super ACE2 acts as a very specific antibody to capture Spike proteins through the RBD domain.
3)Cardio-vascular, blood-pressure and related disorders therapeutic and diagnostic.
4)Anything related to the virus capture such as (i) Mask treatments, (ii) Aerosols, (iii) Sprays and drops, (iv) Ointment and dermal applications, (v) Surfaces
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E. Facemask Having Enhanced Infectious Agent Capturing and Related Methods
1.US Provisional Application No. 63/066,104 filed
Title: Facemask Having Enhanced Infectious Agent Capturing and Related Methods
Assignee:
The invention is a facemask with a filtration material and an infectious agent capture-moiety. Infectious agent capture-moiety refers to any compound or biomolecule that can bind to any infectious agent. The filtration material acts as a scaffold to either directly block or impede the flow-through of the infectious agent or to support the infectious agent capture moiety. The infectious agent capture- moiety then functions to directly block or impede the flow-through of an infectious agent. The infectious agent-capture moiety can aerosolized and sprayed or applied onto pre-treated filtration material and can be specific to capture infectious agents, such as SARS-CoV-2. In such embodiments, the facemasks is capable of providing enhanced protection for the user and to others from SARS-Co
III. CANNABINOIDS
A. Polyfunctional Cannabinoids
1.US Provisional Patent Application No 3/014,471 filed
Title: Polyfunctional Cannabinoids
Assignee:
The invention relates to cannabinoid constructs that may produce more potent response than individual cannabinoid molecules with the additional benefit of being more water- soluble and bioavailable.
Trade Secrets
We rely, in some circumstances, on trade secrets to protect our technology. However, trade secrets can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these procedures, agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors. To the extent that our consultants, contractors, or collaborators use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
Market, Customers and Distribution Methods
Our focus is on the development of innovative diagnostic and pharmaceutical products focusing on diseases and conditions for which currently there are no known efficient therapeutic ingredients or delivery systems. We plan to be an active player in this field of biosciences with our extensive R&D and pipeline of innovative products.
In August, we signed an exclusive licensing, manufacturing, and distribution
agreement with
Competition
The biotech industries are characterized by rapidly advancing technologies, intense competition, a strong emphasis on proprietary products and intellectual property. While we believe that our scientific knowledge, technology, and development experience provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions, some or all of which may have greater access to capital or resources than we do. For any products that we may ultimately commercialize, not only will we compete with any existing diagnostic tests and therapies and those products currently in development, but we will also have to compete with new technologies that may become available in the future.
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We expect that the market will become increasingly competitive in the future. Many of our competitors, either alone or together with their collaborative partners, operate much larger research and development programs, and have substantially greater commercial and financial resources than we do, as well as significantly greater experience in: developing product candidates and technologies, undertaking preclinical studies and clinical trials, obtaining FDA and other regulatory approvals of product candidates, formulating and manufacturing diagnostic products and drug candidates and launching, marketing and selling these candidates. As a result, these companies may obtain marketing approval more rapidly than we are able and may be more effective in developing, selling, and marketing their products.
Source and Availability of Raw Materials
As our scientific team was 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 team decided to make its own VBP. This now in-house development of the core ingredients needed to manufacture our products allows us to control our supply chain.
Government Regulation
On
On
An EUA would allow us to market and sell the test without the need to pursue the lengthy and expensive drug approval process. The FDA may issue an EUA during a public health emergency if it determines that the potential benefits of a product outweigh the potential risks and if other regulatory criteria are met. If an EUA is granted for the test, we will rely on the FDA policies and guidance in connection with the marketing and sale of the test. If these policies and guidance change unexpectedly and/or materially or if we misinterpret them, potential sales of the test could be adversely impacted. In addition, the FDA may revoke an EUA where it is determined that the underlying health emergency no longer exists or warrants such authorization. If granted, we cannot predict how long an EUA for the test will remain in place. The termination of an EUA for the test, if granted, could adversely impact our business, financial condition, and results of operations.
We may also seek additional EUAs from the FDA for our other product candidates for the detection and/or treatment of COVID-19 and the SARS-CoV-2 virus. If granted, the additional EUAs would allow us to market and sell additional product candidates without the need to pursue the lengthy and expensive drug approval process. There is no guarantee that we will be able to obtain any additional EUAs. Failure to obtain additional EUAs or the termination of such EUAs, if obtained, could adversely impact our business, financial condition, and results of operations.
Employees
As of
Costs and effects of compliance with environmental laws
The expense of complying with environmental regulations is of minimal consequence.
Results of Operations
The following discussion of our financial condition and results of operations
for the period ended
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Comparison of the three months ended
For the three months periods ended
Three months Three months
Period Ended Period Ended $ %
31-Mar-21 31-Mar-20 Change Change
Research and development $ 100,953 $ - $ 100,953 100%
Depreciation 6,350 839 5,511 657%
Advertising and promotions 108,987 320,011 (211,024) (66)%
Travel and entertainment expenses 4,835 - 4,835 100%
Office/Other expenses 19,371 30,861 (11,490) (37)%
Licenses and permits 16,851 - 16,851 100%
Legal and other fees 89,615 103,913 (14,298) (14)%
Officers'salary and wages 253,584 115,766 137,818 119%
Consulting fees 72,500 34,000 38,500 113%
Compensation costs 99,740 - 99,740 100%
Audit fees 63,750 20,000 43,750 219%
Filing fees 781 1,390 (609) (44)%
Insurance expense 23,019 30,524 (7,505) (25)%
Taxes 1,597 126 1,471 1,167%
Directors fees 20,000 25,000 (5,000) (20)%
Rent expenses 17,352 - 17,352 100%
Others 1,364 6,296 (4,932) 78%
Total $ 900,649 $ 688,726 $ 211,923 31%
Our operating expenses from continuing operations for the three months periods
ended
Other (Income) expenses:
Our Interest receivable for the three months ended
The Company recorded a change in FMV of trading securities as unrealized gain
(loss) and realized gain (loss) of
Our interest expense of continuing operations for the three months ended
The Company incurred
Going concern
The Company's unaudited condensed consolidated financial statements have been
presented assuming that the Company will continue as a going concern. As shown
in the financial statements, the Company has working capital of
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The Company intends to raise additional capital through private placements of debt and equity securities, but there can be no assurance that these funds will be available on terms acceptable to the Company or will be sufficient to enable the Company to fully complete its development activities or sustain operations. If the Company is unable to raise sufficient additional funds, it will have to develop and implement a plan to further extend payables, reduce overhead, or scale back its current business plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful.
Three months ended
Net Cash Provided by/Used in Operating Activities
Net cash used in continuing operating activities and discontinued operating
activities was
Net Cash Provided by Investing Activities
Net cash used in (provided by) investing activities during the period ended
Net Cash Provided by Financing Activities
Net cash provided by financing activities during the three months period ended
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
Contractual Obligations
As a "smaller reporting company" as defined by Item 10 of Regulation S-K, the Company is not required to provide this information.
Critical accounting policies
The preparation of financial statements in conformity with
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Recently issued accounting standards
Issued In 2021 ASC Update 2021-04
Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic
470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and
Hedging-Contracts in Entity's Own Equity (Subtopic 815-40): Issuer's Accounting
for Certain Modifications or Exchanges of Freestanding Equity-Classified Written
Call Options (a consensus of the
The amendments in this Update affect all entities that issue freestanding written call options that are classified in equity. Specifically, the amendments affect those entities when a freestanding equity-classified written call option is modified or exchanged and remains equity classified after the modification or exchange. The amendments that relate to the recognition and measurement of EPS for certain modifications or exchanges of freestanding equity-classified written call options affect entities that present EPS in accordance with the guidance in Topic 260, Earnings Per Share. The amendments in this Update do not apply to modifications or exchanges of financial instruments that are within the scope of another Topic. That is, accounting for those instruments continues to be subject to the requirements in other Topics. The amendments in this Update do not affect a holder's accounting for freestanding call options.
ASC Update 2021-03
Intangibles-
The amendments in this Update provide private companies and not-for-profit entities with an accounting alternative to perform the goodwill impairment triggering event evaluation as required in Subtopic 350-20 as of the end of the reporting period, whether the reporting period is an interim or annual period. An entity that elects this alternative is not required to monitor for goodwill impairment triggering events during the reporting period but, instead, should evaluate the facts and circumstances as of the end of each reporting period to determine whether a triggering event exists and, if so, whether it is more likely than not that goodwill is impaired. An entity that does not elect the accounting alternative for amortizing goodwill and that performs its annual impairment test as of a date other than the annual reporting date should perform a triggering event evaluation only as of the end of the reporting period. The amendments in this Update do not require incremental disclosures beyond the existing requirements in Topic 235, Notes to Financial Statements, and Subtopic 350-20.
ASC Update 2021-02
Franchisors-Revenue from Contracts with Customers (Subtopic 952-606): Practical Expedient
The amendments in this Update introduce a new practical expedient that simplifies the application of the guidance about identifying performance obligations. The practical expedient permits franchisors that are not public business entities to account for pre-opening services provided to a franchisee as distinct from the franchise license if the services are consistent with those included in a predefined list within the guidance.
ASC Update 2021-01
The amendments in this Update clarify that certain optional expedients and exceptions in Topic 848 for contract modifications and hedge accounting apply to derivatives that are affected by the discounting transition. Specifically, certain provisions in Topic 848, if elected by an entity, apply to derivative instruments that use an interest rate for margining, discounting, or contract price alignment that is modified as a result of reference rate reform. Amendments in this Update to the expedients and exceptions in Topic 848 capture the incremental consequences of the scope clarification and tailor the existing guidance to derivative instruments affected by the discounting transition.
In
The Company has a long-term operating lease, and the long-term operating lease
only took effect in
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In
In
In
In
Other recent accounting pronouncements issued by the FASB and the
Foreign Currency Transactions
Our Foreign currency gain (loss) were
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