BARD1 Life Sciences (ASX:BD1) Presentation, FNN Online Investor Event, October 2021

Company Presentations

BARD1 Life Sciences Limited (ASX:BD1) CEO Dr Leearne Hinch provides an update on its multi-product pipeline diagnostic technologies across a range of different cancers, including breast, ovarian, prostate and other cancers, its strong cash position of $22 million to take the Company's products through development to market in 2023.

So BARD1 is a diagnostics company. We are focused on saving people's lives through the earlier detection of cancer. We're doing that through developing a multi-product pipeline based on our diagnostic technologies across a range of different cancers, including breast, ovarian, prostate and other cancers.

Our lead products are for breast and ovarian cancer and they're based on our SubB2M technology and they've shown outstanding proof of concept results that we released in February of this year. Our go to market strategy for our technology is to partner with diagnostics companies initially in the USA where we intend to launch our breast and ovarian cancer tests as laboratory developed tests in 2023. We also have commercialised products already on the market for bladder cancer and also an exosome research tool. We've got an experienced board management team with healthcare leadership across our board, myself the CEO, and our chief scientist Dr. Greg Rice have significant experience in diagnostics development and commercialisation. And we've also got a team in the U.S., which is focused on our NETs technology.

So BARD1 listed on the Australian stock exchange in 2016 with our auto antibody technology. Last year in July, we acquired Sienna Cancer Diagnostics and we added two technologies, the SubB2M and EXO-NET technologies to our portfolio. We announced in February proof of concept results from our SubB2M tests that saw our share price significantly rise from around 70 cents at the time, up to $4.60. We're currently sitting at around a $100 million market capitalisation and we have a cash position of $22.1 million to fund the further development and commercialisation of our tests through to market in 2023.

So in terms of early cancer detection, essentially the earlier we can detect cancer, the earlier we can treat patients and therefore the better their outcomes and we improve patient five year survival. Ultimately the problem with cancer tests, early detection tests at the moment is there's high false positives meaning that people that are otherwise healthy actually receive a positive result which results in anxiety. And the other issue is lack of sensitivity for early stage cancer which is stages I and II which is what we are trying to detect in order to save people's lives. If we have a look at the graph on the right, I'm not sure if you can see my remote, if we look at the difference between late stage detection and early stage detection, I use ovarian cancer as an example. If ovarian cancer is detected at the late stage, which is stages III and IV there's only 30% survival of women for five years.

Whereas, if we can actually shift late stage detection to early stage detection of stage I that actually results in a 93% survival of women. This is a cancer that we are strongly focused on in terms of our pipeline. The other cancer looking at the moment is breast cancer. Breast cancer is currently diagnosed through mammography. And the average five year survival for women is 90% but there is really high level of recurrence of breast cancer and that's because it's not necessarily detected at the early stage. Again, if we can detect it at early stage that can actually improve cancer survival of breast cancer women for up to 99%. So essentially there's still a very strong unmet need in the market for more accurate and reliable diagnostic tests for early detection of cancer across breast cancer, ovarian cancer, pancreatic cancer which is one of the world's most deadly cancer and prostate cancer which occurs in men.

So the global cancer diagnostics market is a very large market. It's worth over $250 billion covering a range of technologies from early stage screening through to monitoring of cancer in those that have been diagnosed and treated for cancer. The global cancer burden is over 50 million people and there's over 20 million new cases per year and 10 million deaths annually. Our focus, as I said, is on breast, ovarian, also pancreatic and prostate cancers. Overall, there are $11 billion markets and these are some of the world's most common and deadliest cancer. Breast cancers actually took over in 2020 as the number one cancer in the world in terms of the number of people that are living with cancer and an incidence of 2.2 million new cases per year. Prostate cancer is the number one cancer in men only that is and ovarian cancer is actually the deadliest cancer, gynecological cancer in women with over 207,000 deaths per year. And you can see despite that there's a lot more breast cancer, the actual death rates from ovarian cancer is so high due to late stage detection.

If we take a look at BARD1's pipeline of diagnostics, we have, as I said, commercialised products for breast cancer and also for exosome research. Our lead products, which I'm going to talk to you today about are our four SubB2M breast and ovarian cancer products. And we also have some further test for focusing on early detection and monitoring of other cancers. Just so that we point our screening tests are actually for before diagnosis in otherwise healthy people and monitoring occurs as a use after people have been diagnosed with cancer when looking for recurrence.

So what is the SubB2M technology? Essentially, it's a protein that binds specifically to a sugar that's called Neu5Gc. Neu5Gc is a cancer biomarker that is found in human cancer tissues, cells and secretions. In fact, in humans, we've lost the ability to produce Neu5Gc in normal tissue and hence, its only found in cancer tissue. BARD1 has an exclusive license to this technology from The University of Adelaide. And we are developing a number of applications for detection and monitoring of cancers with a focus initially on breast and ovarian cancers. Essentially the SubB2M technology has the potential to improve the accuracy of existing commercial diagnostic tests to create a fast market next generation product for cancer such as ovarian cancer, breast cancer and prostate cancer. We're currently focused on transferring the SubB2M technology from its research stage on what's called SPR instrumentation through to a commercial assay based on immunoassay technology. Immunoassay are used in laboratories worldwide.

If we have a look at our results for breast cancer, our initial results from Griffith University where this work was done, showed that a SubB2M test could detect breast cancer across all stages. So stage I being early through the late stages, stage IV with over 95% sensitivity, the ability to detect cancer and a hundred percent specificity, meaning no false positives across all stages of breast cancer. We're currently working on transferring that SPR based test to a commercial immunoassay and are moving that forward and expect to be able to announce feasibility results for that sometime this year.

The next steps are then taking that test through further assay development and clinical testing for monitoring of breast cancer compared to an existing test called CA15.3 that's already approved for monitoring breast cancer in the USA. Following that we will have technical and clinical validation studies by a laboratory partner that will enable us to launch those tests or that test as a commercial test, laboratory developed test in the USA in calendar year 2023.

In terms of the market potential for this test, at the moment breast cancer is detected using mammography, mammography is a type of X-ray. Only about 70% of women that are eligible to receive a mammogram take up or participate in mammography screening each year.

The current clinical guidelines suggests that mammography should be used every second year. And if I look at the U.S. Market, there's about 60 million women in the U.S. that are eligible for mammography each year which age between the ages of 45 and 74, as I said, this occurs every second year. So as an example, if we got about 10% of that market and the test was priced around $250 per test, that's about a $0.8 billion market in the U.S. alone.

If we move on to ovarian cancer, this again was proof of concept results announced by Griffith University in February of this year. Those results showed a 100% sensitivity and specificity across all stages of ovarian cancer. Again, very good results. We're currently transferring that again to an immunoassay and then we'll be developing and clinically testing that assay compared to the CA 125 marker, which is an existing marker or existing test available on the U.S. market for monitoring ovarian cancer. That will then be followed by technical and clinical validation studies by our laboratory partner in the U.S. and we are currently talking to potential partners for both breast and ovarian cancer tests in the USA that could act as our laboratory partners.

Again, market potential, at the moment, the clinical guidelines do not recommend screening for average risk women, for ovarian cancer. And that's due to the low specificity of existing tests on the market. So there's a big opportunity to develop a test that could be sensitive even specific enough for early detection of ovarian cancer. It's the same target population essentially as breast cancer. And it amounts to about 50 million women between the ages of 50 and 74. Again, a very large market. If we looked at 10% of that market, $250 per test, that's about a $1.3 billion market.

So what are our goals for SubB2M? Essentially, we're looking to develop a more accurate and reliable test for early detection and monitoring of cancer. Our plan is to launch these tests initially as laboratory developed tests in the USA with a clear certified high complexity laboratory partner. That enables a faster market pathway to give us access to early revenues. We'll then follow that up with a full IVD submission with regulatory authorities in the USA and then in other markets in the Europe and Australia. We'll also be looking to expand indications over time to screening across high risk women and later potentially across average risk women.

This shows our activity timeline essentially the way that we develop products, we go through assay development. Once we developed that assay and validated, we clinically test the assay in the pot screening population that we are targeting. Then your partner needs to go through technical and clinical validation of the test, which then enables you to launch the test in the U.S. market. Breast cancer, we are targeting to launch that in the first half of 2023 and ovarian cancer in the second half of 2023.

As I mentioned, we have two tests on the market. We've got an exosome capture tool that we launched in May 2021. And we have a bladder cancer test that's sold through our distributor StatLab in the USA of which we're earning about half a million dollars in revenues per year.

So to finish, why invest in BARD1? We're a cancer diagnostics company with a multi-product pipeline. We've had some compelling results for our breast and ovarian cancer products. And we have a strong cash position of $22 million dollars to take us through to market in 2023.
Thank you everybody. I am Leearne Hinch. Please feel free to give me a call or email me on these numbers here so or 03 9548 7586. Thank you very much.


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