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GBS Inc.

Q22022

2/10/2022

speaker
Operator
Conference Call Operator

Greetings, and welcome to the GBS Inc. Second Quarter 2022 Earnings Conference Call. Currently, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tim McCarthy of LifeSci Advisors, Investor Relations for GBS Inc. Thank you. You may begin.

speaker
Tim McCarthy
Investor Relations, LifeSci Advisors

Thank you, Operator, and good afternoon. Joining us today from the company are Dr. Stephen Boyage, Interim CEO and Chairman of the Board, and Spiro Sekiris, Chief Financial Officer. The press release announcing the results and the update was issued this afternoon and is available now on the GBS website. If you haven't received this news release or if you'd like to be added to the company's distribution list, please send an email to investors.relations at gbs.inc. I will now read the company's safe harbor statement. Some of the statements on this conference call are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements on this call include, without limitation, GVS Inc.' 's ability to develop and commercialize its diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although GBS Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. GBS Inc. has attempted to identify forward-looking statements by terminology including believes, estimates, anticipates, expects, plans, projects, intends, potential, may, could, might, will, should, approximately, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors included in the company's public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. During this conference call, the company may refer to EBITDA, a non-GAAP measure. EBITDA is not and should not be considered an alternative to net income loss income loss from operations, or any other measure for determining operating performance. EBITDA is normally calculated by adding back income tax, depreciation, and amortization to net income loss. I would now like to turn the floor over to Dr. Steven Boyages, Interim CEO of GBS, Inc.

speaker
Dr. Stephen Boyage
Interim CEO and Chairman, GBS Inc.

Steven, please go ahead. Thank you, Tim. Good afternoon, and thank you for joining us on our quarterly business and financial call today. We issued our second financial quarter 2022 preliminary financial and operating results after the close of the market today, and I hope you've been able to look at them briefly. On today's call, I'd like to highlight the key developments the GBS team has made this quarter, highlighting specifically our clinical advancements as well as developments in the build-out of our high-tech manufacturing facility. I'll then turn the call over to Spiro for a detailed review of our financials including our preliminary second quarter results and our forecasted cash burn. As GBS discussed in November, we prioritise the product development and manufacturing aspects of growth as we remain focused on advancing our diagnostics platform around the biosensor technology and grow our lead asset for saliva-based glucose testing. Moving on to a quick business overview. GBS remains focused on developing and commercializing innovative biosensors for point-of-care monitoring and diagnostic tests. Our proprietary technologies incorporate saliva-based testing approaches with accuracy and ease of use not available on the market today. As we build our portfolio of validated evidence, we intend to demonstrate accuracy similar to other fluid-based methods such as serum, blood, or urine. Simply put, We believe when offering patients an affordable, convenient and disposable testing option for people with diabetes, we can drive increased compliance and frequency of testing to drive better outcomes for our patients. We want to reiterate, we prioritise the development and manufacturing of our flagship product, the saliva glucose biosensor, towards our commercialisation goal and are actively working with our licensor LSBD toward regulatory approval in both North America and Asia. Now let's review this quarter's key highlights where we made significant advancements. Firstly, in December, GBS announced that its licensed soil life science biosensor diagnostics, LSBD, had filed an application with the US Food and Drug Administration, FDA, for breakthrough device designation. Based on feedback from the FDA to LSBD, Further data generation would be advisable in order to advance this submission. The team is working towards this goal. Secondly, the team has submitted the correlation clinical trial protocol for institutional review board approval to the Mills Peninsula Medical Center in California, which will be responsible for executing this initial clinical trial enrolling 40 subjects. The objectives of this key study are to explore the relationship between salivary glucose and plasma glucose, as well as the time course data between the two testing modalities using sophisticated glucose tolerance testing in 40 subjects. This will generate time course data to determine salivary glucose characteristics. This is expected to lead to the development of the algorithm between plasma and salivary glucose. It is anticipated that the first stage of this clinical plan to be completed by July 2022. Turning to our manufacturing advancements, following the recent grant of $4.7 million by the Australian federal government to fund the build-out of a high-tech biosensor manufacturing facility, GBS has begun sourcing the required equipment. This sourcing has the dual purpose of immediately utilising the equipment in the interest of efficiency to progress development of the biosensor and at the same time commission this equipment in preparation for the facility. The initial batch of equipment is expected to be ordered in April and finalized in June 2022. This non-dilutive capital is incredibly important for this next phase of manufacturing development in which DBS can accelerate product development through the purchase of several important technical machinery and equipment. Discussions are underway between the University of Newcastle and GBS Inc. for the location, build-out and commissioning of the new high-tech manufacturing facility. In response to the Australian Government's announcement of a medical research commercialisation initiative, GBS is in the process of evaluating and preparing expressions of interest towards further Australian Government funding, as we believe the GBS firmly fits into the objectives of this initiative. The initiative will focus on early-stage translation and commercialization support, which funds support for early-stage medical research and innovation projects with commercial potential. This Medical Research Future Fund will have available to it approximately US$225 million of project funding over the next 10 years of companies that meet the outline criteria now before turning over the call to our cfo spiro securus to discuss the financial second year financial quarter results i feel it important to briefly mention the gbs like the small and micro cap healthcare sector overall experiences volatile equity markets of late And while investors resize valuations and they're needed for capital on an ongoing basis, we remain engaged and committed to driving returns for our stakeholders. Finally, we'd like to thank you for your support and look forward to sharing our successes with you. With that, I would like now to turn the call over to our CFO, Spiro Sekiris, for a more detailed review of our second quarter financials. Spiro.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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