1 unchanged sentence
should read the following discussion in conjunction with our audited historical consolidated financial statements, which are included
−Removed: in the 2021 Form 10-K and our unaudited condensed consolidated financial statements for the fiscal quarter ended March 31, 2022 included
+Added: in the 2022 Form 10-K and our unaudited condensed consolidated financial statements for the fiscal quarter ended September 30, 2022 included
elsewhere in this Quarterly Report on Form 10-Q.
9 unchanged sentences
Forward-Looking
−Removed: statements other than statements of historical fact or relating to present facts or current conditions included in this Quarterly Report
−Removed: on Form 10-Q are forward-looking statements.
−Removed: Forward-looking statements include, but are not limited to, statements regarding expectations,
−Removed: hopes, beliefs, intentions or strategies regarding the future.
−Removed: In addition, any statements that refer to projections, forecasts or other
−Removed: characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.
−Removed: These statements
−Removed: may include words such as “anticipate,” “estimate,” “expect,” “project,” “plan,”
−Removed: “intend,” “believe,” “may,” “should,” “can have,” “likely” and
−Removed: the negative of such words and other words and terms of similar meaning, but the absence of these words does not mean that a statement
−Removed: is not forward-looking.
+Added: statements other than statements of historical fact or relating to present facts or current conditions included in this Quarterly
+Added: Report on Form 10-Q are forward-looking statements.
+Added: Forward-looking statements include, but are not limited to, statements regarding
+Added: expectations, hopes, beliefs, intentions or strategies regarding the future.
+Added: In addition, any statements that refer to projections,
+Added: forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking
+Added: These statements may include words such as “anticipate,” “estimate,” “expect,” “project,”
+Added: “plan,” “intend,” “believe,” “may,” “should,” “can have,”
+Added: “likely” and the negative of such words and other words and terms of similar meaning, but the absence of these words
+Added: does not mean that a statement is not forward-looking.
forward-looking statements contained in this Quarterly Report on Form 10-Q are based on our current expectations and beliefs concerning
1 unchanged sentence
These forward-looking statements are subject to a number of risks, uncertainties
−Removed: and assumptions, including those described in “Item 1A — Risk Factors” of this Quarterly Report on Form 10-Q and in
−Removed: our 2021 Form 10-K.
+Added: and assumptions, including those described in “Item 1A — Risk Factors” of this Quarterly Report on Form 10-Q and
+Added: in our 2022 Form 10-K.
Moreover, we operate in a very competitive and rapidly changing environment.
−Removed: New risks emerge from time to time.
−Removed: It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent
−Removed: to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking
−Removed: statements we may make.
−Removed: In light of these risks, uncertainties and assumptions, the future events and trends discussed in this Quarterly
−Removed: Report on Form 10-Q may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking
+Added: New risks emerge from time to
+Added: It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or
+Added: the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in
+Added: any forward-looking statements we may make.
+Added: In light of these risks, uncertainties and assumptions, the future events and trends
+Added: discussed in this Quarterly Report on Form 10-Q may not occur and actual results could differ materially and adversely from those
+Added: anticipated or implied in the forward-looking statements.
should not rely upon forward-looking statements as predictions of future events.
1 unchanged sentence
statements may not be achieved or occur.
−Removed: Although we believe that the expectations reflected in the forward-looking statements are reasonable,
−Removed: we cannot guarantee future results, levels of activity, performance, or achievements.
−Removed: Except as required by the federal securities laws,
−Removed: we are under no duty to update any of these forward-looking statements after the date of this Quarterly Report on Form 10-Q or to conform
−Removed: these statements to actual results or revised expectations.
−Removed: are a company with a mission to commercialize our unique Biosensor Platform technology and put the power of non-invasive, real-time diagnostic
−Removed: testing in the hands of patients and their primary health practitioners at point of care.
−Removed: an Australian company that owns the worldwide intellectual property rights to the biosensor platform acquired from University of Newcastle,
−Removed: Australia has licensed to us that technology to introduce and launch the platform in the APAC Region, the world license for the SARS-CoV-2
−Removed: Antibody Sensor, and furthermore we own 50% of BiosensX (North America) Inc which has the North American license to the biosensor platform.
−Removed: We were incorporated under the laws of Delaware on December 5, 2016.
−Removed: Our headquarter is in New York.
−Removed: initial priority is to develop & launch two urgently needed non-invasive real time diagnostic tests:
−Removed: Saliva Glucose Biosensor, and
−Removed: SARS-CoV-2 Antibody Biosensor
−Removed: Saliva Glucose Biosensor (“SGB”), together with the software app that interfaces the SGB with the Company’s Digital
−Removed: Information System (“SGT”), the SGT aims to provide a non-invasive and pain free way to make it easier for people to manage
−Removed: innovative technology will aim to free people living with diabetes from having to use painful and invasive blook monitoring devices to
−Removed: manage their condition, giving them a better quality of life.
−Removed: SGB is being developed as a small, printable organic strip designed to put the power of accurate, timely diagnosis in the hands of patients
−Removed: and their primary health practitioners.
−Removed: SGB is manufactured using modified reel-to-reel printing technology which allows mass volume
−Removed: printing at a low cost.
−Removed: Development Plan
−Removed: December, GBS announced that its licensor, Life Science Biosensor Diagnostics (LSBD), has filed an application with the U.S.
−Removed: and Drug Administration (FDA) for Breakthrough Device Designation.
−Removed: Based on feedback from the FDA to LSBD further data generation
−Removed: would be advisable in order to advance this submission.
−Removed: The team is working towards this goal.
−Removed: team has submitted the correlation clinical trial protocol for IRB approval to the Mills-Peninsula Medical Center (MPMC) in California
−Removed: (which will be responsible for executing this initial clinical trial enrolling 40 subjects).
−Removed: The objectives will be:
−Removed: the relationship between salivary glucose and plasma glucose as well as the time course between the two testing modalities using
−Removed: Glucose Tolerance Testing in 40 subjects.
−Removed: of time course date from these studies to determine salivary glucose characteristics.
−Removed: is anticipated that the first stage of this Clinical Plan to be completed by July 2022.
−Removed: Development and Manufacturing Advancements
−Removed: for required equipment has commenced.
−Removed: This sourcing has the dual purpose of immediately utilizing the equipment in the interests
−Removed: of efficiency to progress development of the biosensor and at the same time commission this equipment in preparation for the facility.
−Removed: The initial batch of the equipment has been ordered and is expected to be finalized in June 2022.
−Removed: are underway between the University of Newcastle and GBS Inc for the location, buildout, and commissioning of the new high-tech manufacturing
−Removed: response to the Australian’s government’s announcement of the Medical Research Commercialization Initiative, GBS is in
−Removed: the process of evaluating and preparing expressions of interests towards further Australian Government funding, as we believe that
−Removed: GBS firmly fits into the objectives of this initiative.
−Removed: The initiative will focus on Early-Stage Translation and Commercialization
−Removed: Support, which funds support for early stage medical research and medical innovation projects with commercial potential.
−Removed: Research Future Fund will have available in total approximately $225 million (USD) of project funding over the next 10 years for
−Removed: companies that meets the criteria.
−Removed: Assurance and Regulatory Affairs
−Removed: regulatory affairs plan is underway to address the Asian Pacific (APAC) region requirements.
−Removed: Implementation
−Removed: of new Quality Assurance (QA) system underway.
−Removed: of key suppliers in progress.
−Removed: relation to the potential application of the biosensor towards validating a rapid point-of-care diagnostic test intended to qualify the
−Removed: measurement of antibodies against SARS-CoV-2, we anticipate there to be 3 potential applications for the foreseeable future of population
−Removed: Screening SARS-CoV-2 antibody testing needed to estimate the incidence and prevalence of SARS-CoV-2 infection at the general population
−Removed: vaccination screening - To assess the degree of the elicited potent antigen-specific antibody responses, to SARS-CoV-2 vaccines and
−Removed: determine when booster vaccine shots are needed.
−Removed: – The SARS-CoV-2 test can be used as a complement to the (RNA) virus detection tests for patients presenting late after symptoms
−Removed: onset to healthcare facilities.
−Removed: addition, they can potentially be used for informing the decision on discharge of patients who recovered from SARS-CoV-2 infection
−Removed: but remain RNA-positive by RT-PCR for a long time after symptoms have subsided.
−Removed: The degree of protective immunity conferred by or
−Removed: correlated with the antibodies detected in subjects with past SARS-CoV-2 infection is still under investigation.
−Removed: Once this is clarified,
−Removed: the SARS-CoV-2 antibody tests could be, together with the (RNA) direct virus detection, an essential tool in de-escalation strategies.
−Removed: Currently antibody tests are used for sero-epidemiological surveys and studies.
−Removed: on a recent paper publicly available and authored by the team at Johns Hopkins Department of Environmental Health and Engineering, Bloomberg
−Removed: School of Public Health, results indicate it is feasible to accurately measure the salivary IgG response to identify individuals with
−Removed: a prior SARS-CoV-2 infection.
−Removed: A saliva-based approach could serve as a non-invasive approach for accurate and large-scale SARS-CoV-2
−Removed: “sero”-surveillance.
−Removed: utilizing the Saliva Glucose Test for detecting SARS-CoV-2 we expect to have lower detection limits, improve on sensitivity and specificity
−Removed: characteristics of current diagnostic methods, be able to provide real time results at the point of care and provide quantitative results
−Removed: correlated to the WHO standards as opposed to negative or positive which is how other POCT report the results.
−Removed: COVID Test would increase the scope for diagnosis to be made in the community and outside the laboratory setting.
−Removed: It would have the potential
−Removed: to reduce the time to obtaining an actionable result, it could inform on when people need to get booster vaccine shots and inform appropriate
−Removed: use of isolation resources.
−Removed: Company has not generated any revenues to date.
−Removed: As such, the Company is subject to all of the risks associated with emerging growth companies.
−Removed: Since inception, the Company has incurred losses and negative cash flows from operating activities.
−Removed: The Company does not expect to generate
−Removed: positive cash flows from operating activities in the near future until such time, if at all, the Company completes the development process
−Removed: of its products, including regulatory approvals, and thereafter, begins to commercialize and achieve substantial acceptance in the marketplace
−Removed: for the first of a series of products in its medical device portfolio.
−Removed: public offering
+Added: Although we believe that the expectations reflected in the forward-looking statements are
+Added: reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.
+Added: Except as required by the federal
+Added: securities laws, we are under no duty to update any of these forward-looking statements after the date of this Quarterly Report on
+Added: Form 10-Q or to conform these statements to actual results or revised expectations.
+Added: Bio Solutions Inc.
+Added: (formerly, GBS Inc.) (“INBS”) and its wholly owned subsidiary, GBS Operations Inc.
+Added: were each formed on
+Added: December 5, 2016, under the laws of the state of Delaware.
+Added: Glucose Biosensor Systems (Greater China) Pty Ltd was formed on August 4,
+Added: 2016, under the laws of New South Wales, Australia and was renamed to GBS (APAC) Pty Ltd on October 14, 2020.
+Added: Glucose Biosensor Systems
+Added: (Japan) Pty Ltd and Glucose Biosensor Systems (APAC) Pty Ltd were formed under the laws of New South Wales, Australia on February 22,
+Added: 2017 and February 23, 2017 respectively.
+Added: On October 26, 2022, the Company changed its corporate name (the “Name Change”)
+Added: from “GBS Inc.” to “Intelligent Bio Solutions Inc.” For purpose of the Quarterly Report on Form 10-Q, the terms
+Added: “Company”, “we,” “us” and “our” refer to INBS and its consolidated subsidiaries unless
+Added: context indicates otherwise.
+Added: are a medical technology company operating across the Asia-Pacific region (the “APAC Region”) with an objective to introduce
+Added: and deliver intelligent pain free diagnostic tests.
+Added: We also have an interest in the North America region.
+Added: Our goal is to expand the global
+Added: footprint of our drug screening tests following our recent acquisition of Intelligent Fingerprinting Limited, while continuing to develop
+Added: our Biosensor Platform that we license from Life Science Biosensor Diagnostics Pty Ltd (“LSBD” or the “Licensor”).
+Added: This will be followed by developing both of our platforms to their full capacity across multiple diagnostic modalities of immunology,
+Added: hormones, chemistry, tumor markers and nucleic acid tests.
+Added: of Achievements during the Quarter
+Added: of our major achievements for the quarter ended September 30, 2022 are:
+Added: ● During the quarter ended September 30, 2022 the Company
+Added: negotiated the acquisition of Intelligent Fingerprinting Limited (“IFP”), a company registered in England and Wales and
+Added: on October 4, 2022 the Company closed on the acquisition of IFP (the “Acquisition”).
+Added: connection with the Acquisition, on October 4, 2022, the Company entered into a Share Exchange Agreement (the “Share Exchange Agreement”)
+Added: with IFP, the holders of all of the issued shares in the capital of IFP (collectively, the “Sellers”) and the “Sellers’
+Added: Representatives” named therein (the “Sellers’ Representatives”).
+Added: to the Share Exchange Agreement, among other things, the Company acquired from the Sellers all of the issued shares in the capital of
+Added: IFP, and as consideration therefor the Company issued and sold to the Sellers upon the closing of the Acquisition (the “Closing”)
+Added: an aggregate number of (i) 2,963,091 shares of the Company’s common stock,
+Added: and (ii) 2,363,003 shares of the Company’s series C convertible preferred stock, par value $0.01 per share (the “Preferred
+Added: Up to an additional 1,649,273 shares of Preferred Stock have been reserved for potential future issuance by the Company,
+Added: consisting of (i) 500,000 shares of Preferred Stock, representing approximately 10% of the total Acquisition consideration, that are
+Added: being held back from the Sellers for one year after the Closing to secure potential indemnification claims by the Company against the
+Added: Sellers and (ii) 1,149,273 shares of Preferred Stock to certain lenders to IFP (the “Lenders”) who may, at each such Lender’s
+Added: respective option, convert such Lender’s respective loans to IFP into shares of Preferred Stock, contingent upon approval of the
+Added: Company’s stockholders of the conversion of Preferred Stock into Common Stock, as described below (the “Lender Preferred
+Added: Each Preferred Share would be convertible into three shares of Common Stock, contingent upon approval by the Company’s
+Added: stockholders.
+Added: pursuant to the Share Exchange Agreement, the Company has an obligation to provide IFP with cash in an amount such that IFP is able to
+Added: pay cash payments to certain current and former United Kingdom and United States-based employees and directors (the “IFP Bonus
+Added: Recipients”), in aggregate amounts of £239,707 and $83,043, respectively (the “Cash Bonuses”), plus any applicable
+Added: employer’s National Insurance contributions.
+Added: The Cash Bonuses are being paid to the IFP Bonus Recipients in two equal instalments,
+Added: with the first payment made immediately following the Closing and the second payment to be made on the six-month anniversary of such
+Added: pursuant to the Share Exchange Agreement, the Company has agreed to make available to the employees of IFP (the “IFP Employees”)
+Added: a Company stock option plan in form and substance satisfactory to the Company in relation to up to 1,000,000 shares Common Stock following
+Added: the Closing on the basis that an equal number of Company stock options will be granted to the IFP Employees and Company employees up
+Added: to an aggregate amount of 2,000,000 Company stock options.
+Added: of the Company, IFP and the Sellers made certain customary representations and warranties and agreed to certain covenants in the Share
+Added: Exchange Agreement.
+Added: July 13, 2022, INBS completed Institutional Review Board (IRB) approved clinical studies at the
+Added: Diabetes Research Institute of Sutter Health’s Mills-Peninsula Medical Center (MPMC)
+Added: in San Mateo, California.
+Added: The study design was intended to support the clinical development
+Added: of its next-generation Saliva Glucose Biosensor.
+Added: A total of 40 adult subjects with type 2
+Added: diabetes were recruited for the study.
+Added: Nearly 1,400 samples of blood and oral fluids were
+Added: collected and analyzed.
+Added: The subsequent statistical analysis of the correlation of glucose
+Added: levels among these sample types will act as foundation for building a robust portfolio of
+Added: prospective clinical evidence, forming the backbone for future regulatory submissions.
+Added: Company anticipates further clinical studies in the fourth quarter of this calendar year
+Added: and will utilize Saliva Glucose Biosensors fabricated at the Centre for Organic Electronics
+Added: in New South Wales, Australia
+Added: are continuing to develop our R&D and manufacturing facility at University of Newcastle, Australia.
+Added: During the quarter, we commenced the design of the facility and constructions of the facility
+Added: is expected to start in second quarter of calendar year 2023.
+Added: the quarter, we received and commenced installation of new lab equipment including the Mass
+Added: Spectrometer and GPC systems, which allows to improve the specificity, sensitivity, and reproducibility
+Added: of our Biosensor technology.
+Added: Saliva Glucose Biosensor
+Added: APAC Region includes over 164 million people living with diabetes, which accounts for approximately 38% of the world’s
+Added: diabetic population.
+Added: Rapid urbanization, unhealthy diets and increasingly sedentary lifestyles have resulted in ever increasing
+Added: rates of obesity and diabetes across the region.
+Added: blood glucose monitors were introduced to the market in the 1970s and, since then, the method of glucose self-monitoring has not meaningfully
+Added: The industry remains dominated by invasive methods that ultimately use blood or interstitial fluid to measure glucose.
+Added: the methodology of the Company’s Saliva Glucose Biosensor (“SGB” and, together
+Added: with the software app that interfaces the SGB with the Company’s digital information system, the “SGT”) represents a breakthrough in glucose monitoring as it represents the only non-invasive, painless, and cost-effective
+Added: saliva-based method of measuring glucose levels.
+Added: The biosensor technology has been developed over several decades of university-based
+Added: scientific research and has been extensively referenced in scientific literature.
+Added: SGB is an organic, thin-film transistor, which in its structure embeds the glucose oxidase enzyme (referred to as “ GOX ”).
+Added: When the single-use SGB interacts with saliva it initiates a sequence of enzymatic and electrochemical reactions, producing an electrical
+Added: signal directly correlated to the amount of glucose present in the saliva.
+Added: This measurement is then converted into a real-time saliva
+Added: glucose reading, through the biosensor app installed on a smart device or a dedicated reader.
+Added: The reading may then be stored in a cloud-based
+Added: digital information system.
+Added: patent protected SGB is able to detect glucose in saliva at concentrations between 8 and 200 µM and exhibits linear glucose sensing
+Added: characteristics at these concentrations, sensing glucose at levels 100 times lower than blood.
+Added: our development of the SGT, we aim to go beyond the innovation of changing the sampling medium from blood to saliva, and further create
+Added: value for the patient and the payers by decreasing the cost of managing diabetes, improving the outcomes of the disease and providing
+Added: convenience in testing methodology.
+Added: This will be achieved by directly transferring the SGB reading from the smart device or dedicated
+Added: reader to a cloud-based digital information system to enable all patients the option to create their own medical records where the SGB
+Added: results will be uploaded.
+Added: digital information system is intended to be interfaced to an artificial intelligence system and will be able to, at the patient’s
+Added: or authorized care giver’s direction, disseminate patient data to a remote caregiver, a service for consultation or to any other
+Added: individual with whom the patient chooses to share his or her glucose level measurements.
+Added: We believe patients and payers will be able
+Added: to leverage our digital information system to decrease cost and improve outcomes and convenience.
+Added: the SGB we aim to drive economic value beyond the revenue stemming from the sale of the SGB units – it also allows for monetization
+Added: and the creation of separate revenue streams from the patient network and other data that resides within our digital information system,
+Added: by way of the following:
+Added: The usage of the data, and the analysis and interpretation of the data, to improve
+Added: patients’ conditions and leveraging this insight to improve patient care.
+Added: data sharing.
+Added: The provision of data sharing services between users/patients, authorized care
+Added: givers and authorized medical practitioners.
+Added: The collection of anonymized data, its aggregation with other data from multiple
+Added: sources and multiple health devices and its combination with non-health data.
+Added: plan to leverage this usage, safe sharing and collection of data in the following four revenue-generating channels:
+Added: Monetization Channel .
+Added: This channel focuses on the development of revenue based on commercial relationships for the use of anonymized
+Added: and compliant information derived from data generation.
+Added: These services may include, but will not be limited to:
+Added: ● Fee for service, per performed action by pharma, or other commercial partners.
+Added: ● Subscription, regular recurring payments for continued access to service.
+Added: ● Prescription,
+Added: value acknowledged by payer reimbursement per active user.
+Added: party coverage, other industry/retail players pay fee for their own customers.
+Added: sharing/profit sharing, success-based payment models.
+Added: ● Advertising,
+Added: third party ads tailored to demographic data leveraging characteristics unique to channel.
+Added: value of INBS brand loyalty.
+Added: Adjacencies Channel .
+Added: This channel focuses on the development of revenue from data generated through patient engagement and market
+Added: insights from a clinical and medical perspective.
+Added: These services may include, but will not limited to:
+Added: ● Medical – Generation of Patient Reported Outcomes, or “PROs”.
+Added: Data – Market insights, clinical trial recruitment for third parties, e.g., pharmaceutical
+Added: companies or clinical research organizations.
+Added: Consumer – e-commerce platform, third party customer care, advertising.
+Added: and Service Bundles Channel .
+Added: This channel focuses on ancillary revenue generated through bespoke service opportunities across the
+Added: industry, for example, by working with insurers to develop products that integrate the usage of testing as part of their service offering.
+Added: These services may include, but will not be limited to:
+Added: Over-the-counter model.
+Added: Bundle payment model with insurance subsidy.
+Added: Pay for outcomes model.
+Added: Operations Synergy Channel .
+Added: Through combining the data generation with the use of artificial intelligence, we expect to have a deep
+Added: insight into our customer base, providing an elevated level of customer insight.
+Added: It is expected that this insight will drive high customer
+Added: retention levels and generate a considerable number of broader revenue opportunities through direct and specific interaction with our
+Added: customer base.
+Added: These opportunities may include, but will not be limited to:
+Added: ● Direct access to customers for better experience in customer care.
+Added: Peer learning and support to decrease customer care resource commitment.
+Added: Direct market and customer insights (including better understanding of customer journey).
+Added: More customer data for targeted marketing & marketing impact monitoring.
+Added: New cost effective, digital marketing channel enabling agile marketing approach.
+Added: PRO data to support unique marketing claims.
+Added: Higher engagement, customer loyalty and customer lifetime value.
+Added: Consumer driven innovation and customer involvement in development.
+Added: Involvement in testing & refining to develop demand-oriented products rapidly.
+Added: Easy and fast clinical evaluation recruitment.
+Added: PRO to support regulatory approval / market access for platform tests under development.
+Added: SGB has been under continuous development for over seven years, first by the University of Newcastle, Australia, then by the Licensor
+Added: The SGB development program is currently at the design and manufacturing process development stage, which includes the testing
+Added: needed to verify and validate the final product.
+Added: This stage involves implementation of the clinical evidence module, which incorporates
+Added: the commercial production of the investigative biosensor devices to commence the clinical evaluation of analytical performance of the
+Added: device and generate the clinical evidence necessary to gain regulatory approval.
+Added: May 1, 2020, the Licensor filed a submission with the FDA for the Saliva Glucose Biosensor Diagnostic Test, currently in development
+Added: as a point-of-care test intended to replace blood glucose testing for diabetes management.
+Added: Following the 513(g) submission to the FDA
+Added: (Submitted May 1, 2020), it was determined that the Company could seek the De Novo application pathway for the Saliva Glucose Biosensor
+Added: Diagnostic Test, we were appointed an expert contact person, Acting Branch Chief from the Diabetes Diagnostic Devices Branch.
+Added: further commenced planning discussions with the FDA Office of In Vitro Diagnostics and Radiological Health and the Office of Product
+Added: Evaluation and Quality pertaining to the clinical development and study plan of the Saliva Glucose Biosensor.
+Added: We expect to leverage synergies
+Added: from the planned approval process with the FDA within the Asia Pacific region, We will first seek regulatory approval with the Therapeutic
+Added: Goods Administration (TGA) in Australia.
+Added: However, we intend to apply for regulatory approval in each jurisdiction across the APAC Region.
+Added: SGB is manufactured using modified reel-to-reel printing technology that was developed at the Australian National Fabrication Facility.
+Added: This technology allows mass volume printing at a low cost.
+Added: Previous research published in the journal Solar Energy Materials and Solar
+Added: Cells has shown that the cost of manufacture of printed organic electronic devices (like the SGB) using mass volume printing is $7.85
+Added: per square meter, with an uncertainty of 30%.
+Added: The size of the printed biosensors is approximately one square centimeter, resulting in
+Added: a manufacturing cost per biosensor of approximately $0.01.
+Added: anticipate that the non-invasive nature of saliva-based glucose testing will make patients more amenable to glucose monitoring, with
+Added: the expected result of increasing the number of times a patient tests per day.
+Added: The data generated by the SGB, combined with the interface
+Added: of the smart device or dedicated reader with our digital information system and the artificial intelligence feedback, will allow the
+Added: patient to achieve better glucose control through a practical understanding of lifestyle factors that affect glucose levels, thereby
+Added: helping prevent or delay diabetes complications and ultimately personalizing diabetes management.
+Added: public offering & share structure
December 28, 2020, the Company closed its initial public offering (“IPO”) and sold 1,270,589 units, consisting of (a) one
8 unchanged sentences
proceeds, which amount is net of $1,714,001 in underwriters’ discount and commissions, and $2,153,564 in offering costs.
−Removed: costs include underwriters’ warrants to acquire up to 63,529 shares with an exercise price of $18.70 per share, exercisable until
−Removed: the fifth anniversary of the issuance date.
−Removed: The Company also issued to the underwriter an option, exercisable one or more times in whole
−Removed: or in part, to purchase up to 190,588 additional shares of common stock and/or Series A Warrants to purchase up to an aggregate of 190,588
−Removed: shares of common stock and/or Series B Warrants to purchase up to an aggregate of 190,588 shares of common stock, in any combinations
−Removed: thereof, from us at the public offering price per security, less the underwriting discounts and commissions, for 45 days after the date
−Removed: of the IPO to cover over-allotments, if any (the “Over-Allotment Option”).
+Added: also issued to the underwriter an option, exercisable one or more times in whole or in part, to purchase up to 190,588 additional shares
+Added: of common stock and/or Series A Warrants to purchase up to an aggregate of 190,588 shares of common stock and/or Series B Warrants to
+Added: purchase up to an aggregate of 190,588 shares of common stock, in any combinations thereof, from us at the public offering price per
+Added: security, less the underwriting discounts and commissions, for 45 days after the date of the IPO to cover over-allotments, if any (the
+Added: “Over-Allotment Option”).
the closing of the IPO, all shares of preferred stock then outstanding were automatically converted into 2,810,190 shares of common stock,
and all convertible notes then outstanding were automatically converted into 710,548 shares of common stock.
−Removed: pre-IPO preferred shareholders were issued warrants that, following the Company’s completed IPO, allow the holders to acquire 2,736,675
−Removed: shares of common stock at the IPO price during year two through to year three following the completion of the IPO.
+Added: preferred shareholders were issued warrants that, following the Company’s completed IPO, allow the holder to acquire 2,736,675
+Added: shares of common stock at the IPO price during years two through three following the IPO.
+Added: At the exercise date, the shareholder must
+Added: hold for each warrant to be exercised, one underlying common share to exercise the option.
+Added: The warrants are not transferable and apply
+Added: to the number of shares that were subscribed for.
+Added: share structure as of November 10, 2022 was as follows:
+Added: of Issued Common Stock
+Added: of Series A warrants exercisable at $8.50
+Added: of Series B warrants exercisable at $0 (subject to a cashless exercise provision)
+Added: 2,363,003 of Series C Convertible Preferred Stock
+Added: of Warrants issued to the underwriter exercisable at $18.70
+Added: of the Pre-IPO Warrants exercisable at $8.50 (during year two through year three after the IPO)
+Added: Warrants issued to LSBD exercisable at $17.00
+Added: Minimum Bid Price Requirement
+Added: March 17, 2022, the Company received a letter (the “Notice”) from the Listing Qualifications Department of The Nasdaq Stock
+Added: Market LLC (“Nasdaq”) notifying the Company that the minimum closing bid price per share for its common stock was below $1.00
+Added: for 30 consecutive business days preceding the date of the Notice, and that the Company did not meet the $1.00 per share minimum bid
+Added: price requirement set forth in Nasdaq Listing Rule 5450(a)(1).
+Added: Notice has no immediate effect on the listing or trading of the Company’s common stock on the Nasdaq Capital Market.
+Added: to Nasdaq Listing Rule 5810(c)(3)(A), the Company had a compliance period of 180 calendar days, or until September 13, 2022 (the “Compliance
+Added: Period”), to regain compliance with Nasdaq’s minimum bid price requirement.
+Added: If at any time during the Compliance Period,
+Added: the closing bid price per share of the Company’s common stock is at least $1.00 for a minimum of 10 consecutive business days,
+Added: Nasdaq will provide the Company a written confirmation of compliance and the matter will be closed.
+Added: On September 8, 2022, the Company
+Added: filed a request for a second 180-day period within which to evidence compliance with the $1.00 bid price requirement following the expiration
+Added: of the current compliance period on September 13, 2022.
+Added: No further communication has been received from by Nasdaq as at the date of this
+Added: Quarterly Report on Form 10-Q.
+Added: part of its review process, Nasdaq will make a determination of whether it believes the Company will be able to cure the deficiency.
+Added: If Nasdaq concludes that the Company will not be able to cure the deficiency, or if the Company determine not to submit a transfer application
+Added: or make the required representation, Nasdaq will provide notice that the Company’s securities will be subject to delisting.
+Added: the Company chooses to implement a reverse stock split, it must complete the split no later than ten business days prior to the expiration
+Added: of the second compliance period.
of Operations:
−Removed: of the Three and Nine Months Ended March 31, 2022 and 2021
+Added: of the Three Months Ended September 30, 2022 and 2021
support income
−Removed: support income increased by $158,210 to $192,500 from $34,290 for the quarter ended March 31, 2022 compared to same period in 2021.
−Removed: increase was primarily attributable to GBS Inc.’s subsidiary companies recognizing R&D tax refund as the company believes that
−Removed: it is probable that the certain amount will be recovered in full through a future claim (see note 3 on R&D tax refund).
−Removed: support income decreased by $2,463 to $370,291 from $372,754 for the nine months ended March 31, 2022 compared to same period in 2021.
−Removed: This decrease was primarily attributable to GBS Inc.’s subsidiary companies receiving COVID-19 related government support in the
−Removed: previous financial year which was discontinued in April 2021 offset by the unwinding of deferred income as government support income
−Removed: during the nine months ended March 21, 2022
+Added: support income increased from $0 to $311,320 for the quarter ended September 30, 2022, compared to same period in 2021.
+Added: is comprised of $250,907 as R&D tax refund and $60,413 as unwinding of deferred grant income for which the grant is intended to
+Added: This increase was primarily attributable to INBS’s subsidiary companies recognizing $250,907 as R&D tax refund
+Added: on qualifying research and development expenditures during the three months ended September 30, 2022 as the Company believes that it
+Added: is probable that the certain amount will be recovered in full through a future claim (see the R&D tax refund section of Note 3
+Added: to the unaudited condensed consolidated financial statements included in “Part I, Item 1 — Financial Statements”
+Added: of this Quarterly Report on Form 10-Q and incorporated herein by reference).
and administrative expenses
−Removed: and administrative expenses increased by $108,615 to $1,122,004 from $1,013,389 for the quarter ended March 31, 2022 compared to the
−Removed: same period in 2021.
−Removed: This increase was primarily driven by an increase in operational activities following completion of the IPO in December
−Removed: and administrative expenses increased by $1,251,926 to $3,457,768 from $2,205,842 for the nine months ended March 31, 2022 compared to
−Removed: the same period in 2021.
+Added: and administrative expenses increased by $117,898 to $1,450,418 from $1,332,520 for the quarter year ended September 30, 2022, compared
+Added: to the same period in 2021.
This increase was primarily driven by an increase in operational activities following completion of the IPO
2 unchanged sentences
contribution, consultancy, as well as an increase in employee related costs associated with a higher headcount.
−Removed: and regulatory approval expenses
−Removed: and regulatory approval expenses decreased by $1,742,991 to $413,325 from $2,156,316 for the quarter ended March 31, 2022 compared to
−Removed: the same period in 2021.
−Removed: This decrease is primarily driven by delay in the timing of receipt of invoices from University of Newcastle.
−Removed: and regulatory approval expenses increased by $632,232 to $3,161,306 from $2,529,074 for the nine months ended March 31, 2022 compared
−Removed: to the same period in 2021.
−Removed: This increase is primarily driven by funding availability since completion of the IPO in December 2020 that
−Removed: has allowed the Company to progress on its milestones as well as expensing of the prepaid R&D contribution of $2,600,000.
+Added: and regulatory expenses
+Added: and regulatory expenses decreased by $27,525 to $79,274 from $106,799 for the quarter September 30, 2022, compared to the same period
+Added: This decrease is primarily driven by timing of invoicing for milestones/ research and development activities carried on at the
+Added: University of Newcastle and other research partners.
the Company’s operating activities increase, we expect its development and regulatory expenses to increase in future periods.
−Removed: and capital raising expenses
−Removed: and capital raising expenses decreased by $5,100 to zero from $5,100 for the quarter ended March 31, 2022 compared to the same period
−Removed: This decrease was attributable to final expenditures required by us in the first half of the last financial year to successfully
−Removed: complete our IPO in December 2020.
−Removed: and capital raising expenses decreased by $358,674 to zero from $358,674 for the nine months ended March 31, 2022 compared to the same
−Removed: period in 2021.
−Removed: This decrease was attributable to final expenditures required by us in the first half of the last financial year to successfully
−Removed: complete our IPO in December 2020.
income and expenses
−Removed: expense decreased by $14,344 to $4,217 from $18,561 for the quarter ended March 31, 2022 as compared to the same period in 2021.
−Removed: decrease was attributable to the conversion of convertible notes into common shares after the completion of the IPO in December 2020.
−Removed: expense decreased by $1,086,357 to $4,892 from $1,091,249 for the nine months ended March 31, 2022 as compared to the same period in
−Removed: This decrease was attributable to the conversion of convertible notes into common shares after the completion of the IPO in December
−Removed: foreign exchange gain (loss)
−Removed: foreign exchange gain decreased by $8,764 to a gain of $10 from a gain of $8,774 for the quarter ended March 31, 2022 compared to the
−Removed: same period in 2021.
−Removed: This decrease was largely attributable to the favorable foreign exchange translations on capital raisings from AUD
−Removed: to USD during the same period in 2021.
−Removed: foreign exchange loss decreased by $267,239 to a loss of $3,094 from a loss of $270,333 for the nine months ended March 31, 2022 compared
−Removed: to the same period in 2021.
−Removed: This decrease was largely attributable to the unfavorable foreign exchange translations on capital raisings
−Removed: from AUD to USD during the same period in 2021.
+Added: expense increased from $0 to $1,065 for the quarter ended September 30, 2022, as compared to the same period in 2021.
+Added: This increase was
+Added: attributable to the payment arrangement for directors and officers insurance policy.
+Added: foreign exchange loss
+Added: foreign exchange loss decreased by $871 to $2,247 from $3,118 for the quarter ended September 30, 2022, compared to the same period in
+Added: This decrease in loss was largely attributable to the favorable exchange rates while settling transactions in currencies other
+Added: than its functional currencies.
tax (expense) benefit
−Removed: was no income tax expense for the three and nine months ended March 31, 2022 and 2021, respectively, and the Company has established
−Removed: a full valuation allowance for all of its deferred tax assets.
−Removed: comprehensive loss
−Removed: currency translation loss
−Removed: foreign currency translation loss decreased by $264,825 to a $2,793 gain from a $262,032 loss for the quarter ended March 31, 2022 as
+Added: was no income tax expense for the three months period ended September 30, 2022, and 2021, respectively, as the Company has established
+Added: a full valuation allowance for all its deferred tax assets.
+Added: comprehensive income
+Added: currency translation gain/(loss)
+Added: foreign currency translation loss increased by $68,077 to a loss of $135,559 from a loss of $67,482 for the quarter ended September 30,
2022, compared to the same period in 2021.
−Removed: It is calculated based on the Company’s unsettled transactions in currencies other than its
−Removed: functional currency.
−Removed: foreign currency translation loss decreased by $221,410 to a loss of $57,334 from a loss of $278,744 for the nine months ended March
−Removed: 31, 2022 as compared to the same period in 2021.
−Removed: It is calculated based on the Company’s unsettled transactions in currencies other
−Removed: than its functional currency.
−Removed: loss decreased by $1,792,567 to $1,335,246 from $3,127,813 for the quarter ended March 31, 2022 compared to the same period in 2021.
−Removed: This decrease is primarily driven by higher expenditure incurred on research and development activities in the same period in 2021.
−Removed: loss increased by $43,609 to $6,227,896 from $6,184,287 for the nine months ended March 31, 2022 compared to the same period in 2021.
−Removed: This increase is primarily driven by the expansion of the Company’s operational activities in order to progress on its regulatory
−Removed: and development milestones.
+Added: It is calculated based on the Company’s unsettled transactions in currencies other than
+Added: its functional currency.
+Added: loss attributable to INBS decreased by $224,359 to $1,208,293 from $1,432,652 for the quarter ended September 30, 2022, compared to the
+Added: same period in 2021.
+Added: This decrease in loss is primarily due to recognition of government support income in the current quarter due to
+Added: expenditure incurred on qualifying research and development activities.
and Capital Resources
1 unchanged sentence
We define Working Capital as current assets less current liabilities.
−Removed: The calculation of Working Capital provides additional information
−Removed: and is not defined as a measure of financial performance under GAAP.
This measure should not be considered in isolation or as a substitute
2 unchanged sentences
companies in our industry may calculate this measure differently than we do, limiting its usefulness as a comparative measure.
−Removed: our inception, our operations have primarily been financed through the issuance of our common stock, convertible preferred stock and
−Removed: the incurrence of debt.
−Removed: As of March 31, 2022, we had $10,756,089 in cash and cash equivalents and $8,433,248 in working capital.
−Removed: to our management’s estimates, based on our budget and proposed schedules of development, approvals and organization, we believe,
−Removed: although there can be no assurances, we will have sufficient capital resources to enable us to continue to implement our business plan
−Removed: and remain in operation for at least up to the first half of 2023.
−Removed: During this time, we expect to use the net proceeds available to us
−Removed: for the following purposes:
−Removed: obtain regulatory approvals and establish manufacturing capacities necessary for marketing of the SGT;
−Removed: market the SGT and establish a distribution network in the APAC Region;
−Removed: working capital and general corporate purposes.
+Added: our inception, our operations have primarily been financed through the issuance of our common stock, redeemable convertible preferred
+Added: stock and the incurrence of debt.
+Added: As of September 30, 2022, we had $5,742,626 in cash and cash equivalents and $5,850,203 in working
+Added: “Initial public offering & share structure” herein for details about our IPO.
+Added: Company expects that its cash and cash equivalents as of September 30, 2022, may be insufficient to allow the Company to fund its
+Added: current operating plan through at least the next twelve months from the issuance of these financial statements, taking into account
+Added: the acquisition of Intelligent Fingerprinting Limited.
+Added: Should revenue not be generated during this period to
+Added: cover expenses, then these conditions may raise substantial doubt about the Company’s ability to continue as a going concern
+Added: for a period of at least one year from the date these financial statements are issued.
+Added: It appears that the Company will be required
+Added: to raise additional funds during the next 12 months.
+Added: The Company is currently evaluating potential raising additional funds through
+Added: private placements and or public equity financing.
+Added: However, there can be no assurance that, in the event that the Company requires
+Added: additional financing, such financing will be available on terms which are favorable to us, or at all.
+Added: Accordingly, these factors raise substantial doubt about the Company’s ability to continue as a going concern.
do not anticipate generating any revenue in the near future, until such time, if at all, the Company completes the development process
10 unchanged sentences
capital earlier than anticipated.
−Removed: the event we require additional capital, there can be no assurances that we will be able to raise such capital on acceptable terms, or
−Removed: Failure to generate sufficient revenues or raise additional capital through debt or equity financings, or through collaboration
−Removed: agreements, strategic alliances or marketing and distribution arrangements, could have a material adverse effect on our ability to meet
−Removed: our long-term liquidity needs and achieve our intended long-term business plan.
−Removed: Our failure to obtain such funding when needed could
−Removed: create a negative impact on our stock price or could potentially lead to a reduction in our operations or the failure of our company.
−Removed: “Initial public offering” above for details about our IPO.
+Added: the event we require additional capital, there can be no assurances that we will be able to raise such capital on acceptable terms,
+Added: Failure to generate sufficient revenues or raise additional capital through debt or equity financings, or through
+Added: collaboration agreements, strategic alliances or marketing and distribution arrangements, could have a material adverse effect on
+Added: our ability to meet our long-term liquidity needs and achieve our intended long-term business plan.
+Added: Our failure to obtain such
+Added: funding when needed could create a negative impact on our stock price or could potentially lead to a reduction in our operations or
+Added: the failure of our company.
+Added: Accordingly, these factors raise substantial doubt about the Company’s ability to continue as a going concern.
Transition Period for “Emerging Growth Companies”
8 unchanged sentences
or prospects in comparison to other public companies, which may have a negative impact on the value and liquidity of our common stock.
−Removed: Sheet Arrangements
−Removed: of March 31, 2022, we do not have any off-balance-sheet arrangements that have, or are reasonably likely to have, a material current
−Removed: or future effect on our results of operations or financial condition, revenues, expenses, results of operations, liquidity, cash requirements
−Removed: or capital resources.
−Removed: Accounting Policies and Use of Estimates
−Removed: preparation of our unaudited condensed consolidated financial statements in conformity with GAAP requires management to make judgments,
−Removed: estimates and assumptions that impact the amounts reported in our consolidated financial statements and accompanying notes that are not
−Removed: readily apparent from other sources.
−Removed: The estimates and associated assumptions are based on historical experience and other factors that
−Removed: are considered relevant.
+Added: Accounting Estimates
+Added: preparation of our consolidated financial statements in conformity with GAAP requires management to make judgments, estimates and assumptions
+Added: that impact the amounts reported in our consolidated financial statements and accompanying notes that are not readily apparent from other
+Added: The estimates and associated assumptions are based on historical experience and other factors that are considered relevant.
Actual results may differ from these estimates.
−Removed: critical accounting policies are described in the 2021 Form 10-K, and the notes to the unaudited condensed consolidated financial statements
−Removed: included in “Part I, Item 1 — Financial Statements” of this Quarterly Report on Form 10-Q and incorporated herein by
−Removed: the three and nine months ended March 31, 2022, there were no material changes to our critical accounting policies from those in the
−Removed: 2021 Form 10-K.
+Added: critical accounting policies are described in our Annual Report on Form 10-K filed with the SEC on September 22, 2022, and the notes
+Added: to the unaudited condensed consolidated financial statements included in “Part I, Item 1 — Financial Statements” of
+Added: this Quarterly Report on Form 10-Q.
+Added: the three months ended September 30, 2022, there were no material changes to our critical accounting policies from those in our June
+Added: 30, 2022, Annual Report on Form 10-K filed with the SEC on September 22, 2022.
issued Accounting Pronouncements
6 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.