Greetings, and welcome to the GBS Incorporated Fourth Quarter 2021 Earnings Conference Call. Currently, all participants are on a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Alex Arzeno, Investor Relations for GBS. Thank you. You may begin..

Thank you and good afternoon. Joining us today from the company are Harry Simeonidis, President and CEO; and Spiro Sakiris, Chief Financial Officer. A press release announcing the results and the update was issued this afternoon and is available now on the GBS Web site. 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 Private Securities Litigation Reform Act of 1995, which involves risks and uncertainties.

Forward-looking statements on this call include, without limitation, GBS 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 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 has attempted to identify forward-looking statements by terminology, including believes, estimates, anticipates, expects, plans, projects, intents, 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, including the company's public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in the press 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 does 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, amortization to net income loss. I would like to now turn the floor over to Harry, President and CEO of GBS.

Harry, please go ahead. .

Thank you, Alex. Good afternoon and thank you for joining us on our quarterly business and financial update call today. We issued our fourth quarter and full year 2021 financial and operating results after the close of market today, and I hope you've been able to review them.

GBS is focused on developing and commercializing innovative biosensor point-of-care monitoring and diagnostic tests. We leverage propriety technologies, which allow saliva-based testing approaches to be as accurate as other broad-based methods such as serum, blood, or urine.

We believe offering patient a convenient, low cost and disposable test strip as small as a piece of gum will allow compliance and frequency of testing to reach new levels in developed economies.

GBS’ goal is to have our technology readily available to both patients and physicians at an affordable price that will be comparable to what is on the market today. We have identified 130 additional diagnostic tests.

In due time, we anticipate our technology will have broad applications across different diagnostic modalities, enabling diagnostic tests such as clinical chemistry, immunology, tumor markers, allergens and endocrinology.

The biosensor technology was developed at the University of Newcastle, Australia, and was acquired by Life Science Biosensor Diagnostics Propriety Limited. The technology was then licensed to GBS for the Asia Pacific region and has been under continuous development with GBS over the last seven years.

The biosensor is a platform technology which uses proprietary organic thin film transistor technology, which is patent protected till the year 2033. Currently, we are advancing two lead product candidates towards commercialization.

First, our flagship product candidate is a novel Saliva Glucose Biosensor, a convenient point-of-care test expected to substitute the invasive finger pricking blood glucose monitoring for patients living with diabetes.

And second, our Saliva SARS-CoV-2 antibody test candidate, which will provide real-time quantitative detection for SARS-CoV-2 virus antibodies. With respect to our Glucose Biosensor technology for patients living with diabetes, we believe our tests will have the ability to make blood-based finger-prick testing obsolete.

When you look at patients’ preference, as we have done extensively throughout our patients survey, our Saliva-based Glucose Biosensor, that is pain free, non-invasive, simple to use, and convenient is the preferred method when compared to the current blood testing mechanisms available today.

Unfortunately, there have been little to no recent announcement around testing for people living with diabetes. And this is where we see the very attractive opportunity. Diabetes is a global epidemic. And the disease is growing rapidly with markets estimated to exceed 465 million people, and we expect to grow to 700 million by the year 2045.

Our commercial license applies to the world's largest diabetes population in the Asia Pacific region. This is the market that GBS will be addressing to bring an affordable non-invasive, real-time point-of-care diagnostic test to people living with diabetes.

Rapidly rising rates of diabetes have been seen in the APAC region and according to the latest data, more than 170 million people living with diabetes, representing over 36% of the world's total population are people living with diabetes.

Given what we believe are the superior analytical characteristics of the biosensor technology and the current development stage, it was important that GBS with its global license agreement joined the international effort to combat the COVID-19 pandemic with its first class technology.

In 2020, as the emergence of COVID-19 infections began to skyrocket exponentially, GBS decided to expedite a collaboration with the Wyss Institute of Biologically Inspired Engineering at Harvard University in order to develop a more accurate and real-time SARS COVID antibody testing to support both the international law vaccination efforts and testing.

This past quarter, and indeed the year, has been one of both challenges and opportunities, as COVID-19 has become a focal point across the global healthcare industry, and a good part of our daily lives.

Today, as we learn more about the Delta variant, we must all recognize that COVID-19 is not going to be eradicated as easily, and we must remain vigilant. Recent reports from the World Health Organization and CDC indicate this new strain is more contagious and can allow people already vaccinated to transmit the virus.

While these developments are unfortunate, on so many levels, it is important that we as a society now understand the importance of COVID testing, and how we can implement these tools in our lives so we can better prepare for any future pandemics that arise.

At GBS, we are proud to be joining the efforts to enhance healthcare diagnostics by providing convenient and accurate antibody testing as a long-term efficacy of approved vaccinations have yet to be demonstrated clinically.

Clinically, GBS’ fourth quarter and full year financial results which our CFO, Spiro Sakiris will discuss in greater detail shortly, represented another solid period for our NASDAQ listed company, creates an awareness across the medical and investor communities. Briefly, I’d just like to highlight a couple of financial points to start.

In December 2020, we went public by an initial public offering and raised 21.6 million in gross proceedings and listed on the NASDAQ global stock markets. Proceeds from this financing were to be utilized to obtain regulatory approvals, pipeline advancements, marketing and establishing a distribution network in addition to working capital.

And most recently, GBS was awarded a grant of $4.7 million from the Australian Federal Government to fund the build-up of our high-tech biosensor manufacturing facility.

This recognition goes beyond just the value of the grant, as biosensor platform technology was identified by the Australian government as one of only six National Manufacturing Priorities under its Modern Manufacturing Strategy. The facility will be solely focused on advancing GBS’ products.

We continue to be fiscally responsible and have multiple tools and strategies to extend our cash runway through sublicensing and collaborations, which have been provided as a diverse set of financial opportunities to the company. Now let's review some of our recent key highlights.

Our core focus remains on the product development on both our Saliva Glucose and Saliva SARS-CoV-2 antibody tests.

In February of this year, we announced the execution of a sponsored research agreement with Johns Hopkins Bloomberg School of Public Health to accelerate the development of the saliva collection protocols for the saliva-based diagnostic tests.

This collaboration pulls together resources from John Hopkins Environmental Health and Engineering as well as its School of Public Health and the lab's Salivary Biomarkers and Infectious Diseases Program.

In February, GBS also announced its collaboration with the Wyss Institute of Biologically Inspired Engineering at Harvard University to develop a COVID-19 antibody test, subsequently to integrate the Wyss Institute rapid test [ph] technology with GBS’ proprietary transistor sensor technology.

Later in the spring, we received approval from Harvard Longwood Campus Institute Review Board to commence the validation study to test clinical samples from the COVID-19 repository.

In order to advance these assets into commercialization plays as effectively as possible, management has preemptively executed certain priorities to ready the company post an approval.

In June, GBS completed a global voice of customer survey of people living with diabetes to verify the desirability, discuss the applications in their daily life and review the product features of its Saliva Glucose Biosensor. Key findings were; in all markets, 9 out of 10 patients responded positively to our biosensor platform.

7 out of 10 patients were seriously interested in purchasing the product when it is released. And 3 out of 10 wanted to be placed on a pre-order waiting list ahead of the product release. Finally, more patients in the U.S.

indicated the price on a pain free alternative to current glucose monitoring will play a role in determining the decision to purchase a new device. Patients in China indicated price was not an issue as long as the product was accurate and reliable. Most recently, we engaged with L.E.K.

Consulting to deliver a shortlist of suitable commercial partners for distribution in China as we prepare for the initial discussion with potential collaborators in this region.

On behalf of GBS’ senior management team, I want to express our gratitude to all our employees for their perseverance and dedication to the company in these challenging times.

Our continued grit and perseverance can bring a shift to the point-of-care diagnostic industry as affordable saliva-based testing will one day deliver a more accurate and convenient way to conduct accurate testing.

GBS’ goal is to align our tests to our patients' needs, by providing an affordable non-invasive test at point-of-care in an easy and administrative test strip. We can empower patients to test easily and safely for multiple indications.

We have made important benefits across the organization in 2021, and we are confident in both our development and commercial approach as well as our ability to execute on each year ahead. With these insights, I would like to now turn and call over our CFO, Spiro Sakiris for a more detailed review of the 2021 financials.

Spiro?.

Thanks, Harry. As Harry mentioned, 2021 was an impressive year of advancement and development of GBS’ biosensor-based point-of-care tests, but also for GBS as a growing organization.

For the year ended June 30, 2021, the company had a preliminary net loss of 8.5 million, or $0.68 per share, compared to net loss of 3.3 million, or $0.37 per share for the same period last year. This is predominately due to the acceleration and the development of our commercialization expenditure.

In December 2020, the company closed its IPO and generated approximately 19.7 million in net cash proceeds. Government support income was 578,000 for the three months ended June 30, 2021 and zero for the same period in 2020, respectively.

The company is set on the path from the IPO to utilize the key resources and commercial partners to advance the projects towards commercializing.

To achieve this, acceleration of expenditures is required with the major categories being development and commercialization for the financial year of 3.8 million compared to the year prior of 0.6 million, and employee benefits expense of 1.7 million compared to the year prior of 1.1 million.

As of June 30, 2021, the company's cash, cash equivalents and marketable securities totaled approximately 12.7 million compared to approximately 430,000 on June 30, 2020. As of June 30, 2021, the company had 12.4 million shares outstanding.

Management continues to be fiscally responsible and has multiple tools and strategies to extend its runway through sublicensed agreements and collaborations which will provide a diverse set of funding options to the company.

GBS is of the view that the current operating plan and financial resources, its cash, cash equivalents and marketable securities, as of June 30, 2021, will be sufficient to cover expenses and capital requirements into the fourth calendar quarter of 2022. I'll now turn it back to Harry for the closing remarks. .

Thank you, Spiro. As Spiro made it clear, we are very proud of our accomplishments we have made this year.

Heading into fiscal year 2022, we anticipate benefiting from, among others, developing SARS-CoV-2 antibody biosensor for FDA, EUA submission, completing clinical protocols for FDA review for Saliva Glucose Biosensor, establishing the world's first validated traceable saliva glucose reference method in collaboration with John Hopkins.

Progressing design transfer to manufacturing for our Saliva Glucose Biosensor, securing out licensing and some licensing partnership opportunities for commercialization in the APAC region, and finally, completing our build of a high-tech biosensor facility.

We as management and the Board are working in a lockstep to channel GBS’ robust capabilities to benefit all its shareholders and ultimately enhance shareholder value. We will now open the call for questions. Operator, please open the floor to questions..

Thank you. Ladies and gentlemen, at this time we'll be conducting a question-and-answer session. [Operator Instructions]. Our first question comes from Brian Vandermosten [ph] with Zacks SCR. Please proceed with your question..

Thank you. This is John Vandermosten. Good day to you guys. Harry, Spiro, good to chat with you. First question is on the L.E.K Consulting. Hopefully, that's coming along great.

What are some of the characteristics you're looking for in the partners for distribution in the APAC region?.

Hi, John. Thank you for your question and really appreciate that. Thanks for joining as well. John, the characteristics in terms of any other distributors going into our market is ensuring that they first of all have the capability to reach as many patients as possible. So they do require a prior footprint within the market.

The other key aspect that they do require and the capabilities that we are looking for in our partners is the ability to be very well connected both with the healthcare industry, but also from the regulatory standpoint, as it is very important when we bring this product to market, that we enter the market very fast. So those are the key aspects.

Obviously, a lot more characteristics when looking for the ideal partner, but in summary, one, we've got an existing footprint, so we can get into the market very fast. And secondary is having strong relationships, both with healthcare and with regulatory bodies..

Okay, great. That makes sense. And one of the goals you outlined for, I think in a previous quarterly update, was achieving the clinical protocol. And I think you guys have achieved that now.

Were you able to touch base with the EMA and the FDA to help develop that, or is that something still that you're going to refine going forward? And how does it look in terms of talking to the agencies to get their input before you finalize them?.

Yes, John, again, a great question. Look, it's always important to ensure that when we do talk to the authorities, we've got all our ducks in a line as well. On that aspect, we continuously do talk to the FDA, ensuring that we have got the right process and methodology as we move forward.

We are in the process right now doing a pre-submission with the FDA so we can actually ensure that all our protocols are in place. And that is expected to continue over the next quarter or so. So as you do explain, yes, absolutely. We are advancing our clinical protocols.

And when we are ready to finalize those, we'll be doing a submission to the FDA, which we expect hopefully this year..

Okay, great.

And last one for me is, is there a timeline on the construction of that manufacturing facility? Is that something we expect I guess in the next month or next quarters, or what should we think about in terms of timeline for having that online?.

John, we have commenced straightaway as soon as we got the grant, which we were one of only six companies in Australia that was given this grant. And we were very excited about this. We started straightaway. So we've actually shortlisted a number of sites as [indiscernible].

And that will be accelerated in terms of once we get in there and then start ordering the equipment and doing the manufacturing through there. We expect that one to be -- we expect to have a site identified and into an agreement by the end of this quarter.

And then the completion of the build, depending on the timeline of sourcing the manufacturing and the equipment that we need for the facility, because this is a very high tech facility that we are building. We anticipate that to be done or completed by the first half of next year..

Okay, great. Thank you for the detailed timeline there. I appreciate it. Thank you, Harry. Thank you, Spiro..

Thank you, John. Always a pleasure..

At this time, there are no further questions. I'd like to turn the floor back over to Mr. Simeonidis for closing remarks..

Thank you, operator. Thank you everyone very much for joining our call today. We remain very excited for the future of GBS and its multiple product opportunities in both the near and long term.

Our biosensor technology has fueled our passion to develop affordable, non-invasive, real-time point-of-care diagnostic tests for both patients and their primary healthcare providers. We appreciate everyone's support and thank you again for joining our annual conference update call..

Thank you for your participation. You may disconnect your lines at this time, and have a great rest of the day..