I thought Jane hit the key points of the business and where it's at well.

1. Bcal Diagnostics has developed a blood test for early detection of breast cancer after 14 years of clinical research. The test looks at lipid biomarkers and can differentiate between breast cancer and non-breast cancer patients with 90% sensitivity and 85% specificity.

2. The test is being introduced as an adjunct to mammography initially, not as a replacement. It provides an additional tool for breast cancer detection, especially for the 50% of women who currently avoid mammograms. Other important markets are monitoring women previously diagnosed with breast cancer and testing women under 40.

3. Bcal has been clinician-led in its development, working closely with leading breast cancer doctors to collect high-quality samples under strict protocols. This gives clinicians confidence in the test. Over 4,000 samples have been collected across Australia, Europe and the US.

4. Commercialization is planned to start in late 2024 through the company's own NATA-accredited lab initially as a Lab Developed Test. Partnerships with national pathology providers for greater scale are also being discussed. Unit economics, logistics and process optimization have been a major focus.

5. While an out-of-pocket test initially around the $300 price point, the company is working with advocacy groups to lobby the government for reimbursement to enable wide accessibility. Health economic data will be key for this. Overall, the test represents a major new tool in the early detection of breast cancer.

I missed the interview. But just caught up.

Summary - I think there are other competitors out there that are better placed to scale.

The main issue I can see with BCAL is that it needs it's own propriatary equipment to perform its blood test. Whereas, it's competitor, IIQ's SubB2M Breast Cancer test can be used with the existing equipment in existing pathology providers globally. So BCAL would need to have much better results than IIQ to justify the extra capex spend...but it has about the same sensitivity and specitivity. So I can't see how BCAL will scale compared to its competitors. Am i missing something?

When asked about the timeline to commercialisation compares between BCAL and IIQ, said she wasn't across IIQs timeline. But Jayne should be across all her competitors! Or at least say why the BCAL product is better etc. This left me cold.

Jayne also answered the question regarding Exosomes in a strange way. She was asked her views on exosomes in diagnosis...but only spoke about theraputics. So pretty much avoided the question. And the research has shown that exosomes in diagnosis is the future.

Also I note that Andrew Chapman's Merchant Fund has recently sold a large portion of their BCAL holdings. But has maintained their IIQ holdings and I have a feeling will invest more at the Cap Raise that is likey for IIQ in the near future to commercialise.

Parko

Disclosure - I have a very large IIQ holding.

BCAL have executed a Master Services Agreement with Precison, a US based lab, to develop the standardised assay tests.

No commentary on cost to be spent under the agreement however I note they have circa $2m to expend over the first two years of operations according to the fund allocation information provided as part of the prospectus. They have already worked through $900k per the December update so I would be expecting to see those numbers continue throughout the upcoming 4C's.

Worth a note as well is that the commencement of this stage in mid year 2022 is right on the timeframe shown in the prospectus (it's due to run into 2024).

The company continues to roll towards commercialisation.

The share price has not moved following this announcement and continues to trade at circa 8c. Well below the 25c IPO level.

This presents a great FOMO movement for me. I've previously noted my goal to buy in around Jan 2023, pending the company continuing to proceed in line with its plans.

Since then i've watched the share price drop and drop while the company has steadily hit it's communicated milestones.

From a fundamentals standpoint I don't believe anything the company has done has been detrimental to cause this reduction and it's instead a combination of being a pre-revenue, high risk bio stock in the current economic environment.

FOMO continues.

Plans to buy in remain the same.

Announcements by BCAL on the 6 and 7 February expressing their positive response to independent analysis of their research data has resulted in a considerable up swing in share price to 15c (as at 10 Feb) from a low of 9.5c on the 25 Janurary

BCAL Executive Chair Jayne Shaw said that the new independent review provides the Company with strong assurance in advancing the test’s development towards commercial use, both in Australia and the USA.

She said, “This independent review confirms what we’ve long been confident of at BCAL, the ability to detect breast cancer using a lipid based blood test. The new developments solidify BCAL’s commercialisation pathway in the Australian, USA and European markets. As we welcome our new CEO Dr John Hurrell, BCAL will benefit from his strong leadership and detailed industry experience in moving the BCAL test to its next stages of development. We are thrilled by this outstanding advancement for BCAL within just six months since our IPO.”

Following the announcement released by the company on 7 Feb. A more detailed update has been provided to the market. Specifically, in relation to the reported discovery of achieving similar outcomes with less markers.

I’ll avoid going into the specifics of the tests and the outcomes as I’ll likely misrepresent what’s been said as I am as far from a scientific professional as one can get. However, I will note that;

-         The company continues to be very positive as to the discovery of the reduced marker outcome.

-         The company has noted they may be able to seek additional patent protection due to this discovery.

-         They company has reiterated that this outcome can ‘considerably improve its commercial feasibility, attractiveness, reducing the time, cost and difficulty of analysis of each sample’.

Fun times ahead.

The company has released an update today (7 Feb 2022).

In brief;

-         Testing continues;

-         3^rd party testing has backed up in house testing; and

-         Possible path to achieve same outcomes faster, cheaper and easier.

In more detail;

-         Both the company and an independently engaged 3rd party have completed analysis of the latest patient samples

-         The review completed by the 3^rd party included all samples gathered to date (790), not just the latest round.

-         Consistent performance was achieved which supports the company’s local blind test finding.

-         In addition, the Company has achieved an identification using less markers than the test has previously been based on. Original testing used 18 different markers; this revised test used 6 to 10. This needs to be reproduced but initial outcome is positive.

-         Company has noted that if the reduced marker identification can be replicated than this could result in a greatly more commercially feasible product.

How this relates to the overall picture:

Positive update both from an established milestone perspective and a possible unforeseen upside perspective.

Current Financial Position;

-         $479k spent in this last quarter.

-         The company has been public for circa 2 quarters both of which have some in’s and out’s that need to be taken into consideration when judging how quickly that money is going out the door (i.e Q1 was $1.5m and included $807k associated with the offer, Q2 had circa $400k of inflow from GST and R&D elements).

-         That being said, the company forecast a circa $4.1m spend in year one and with $2m and change out the door they are on-track.

-         The 4C lists 23.7 of quarters of funding left based. That’s a bit warped by the nature of how that funding line is calculated. Based on the advice noted above I’m expecting to see the next two quarters back up at the $1m mark, with possible higher numbers pending the commercialisation process and that estimate to come down in subsequent updates (currently 11 quarters left based on my previous chicken scratchings).

Progress Update:

-         New CEO appointed! I won’t break this down as some dashing individual has already done this in a straw below.

-         Clinical Sampling continued (additional 190) and processing of existing samples (301 in number) returned positive results. The company has noted that reproducing the results at such a high level (level not refenced) provides additional reinforcement to the team and possible pathways to accelerate development.

-         Key items to see in Q1 of this calendar year are;

o  Commencement of additional sample analysis, via an agreement with the Baker Institute (Melbourne based).

o  Execution of an agreement with a company in the US to commence sample collection in that region.

-         Key items to see in Q2;

o  Achievement of ISO certification.

Summary/Thoughts;

-         Company’s expenditure is tracking per expectation.

-         Sampling and analysis updates are continuing and don’t appear to have been greatly impacted by the last two COVID years.

The time frame in the perspective had Study 1 (stage 1) being completed by end of 2022 with 1,000 participants.

With circa 500 sampled/tested so far I’d imagine they would want to hit the 1,000 mark by end of Q3 CY at latest to allow the last three months to analysis the samples and have that full cohort complete by Christmas.

-         No further update provided on the US Patent process. I assume that will come in the next update, particularly once the new CEO is up and running and, hopefully, the agreement has been executed with the US based sample collection organisation.

Do I / Should I / Will I Buy

-         The company is still at a very, very early stage with the majority of their risks unresolved.

In addition there is, at least, one other Australia company looking to commercialise a product targeted at the same issue who are already in market with product adjacent presence and agreements.

-         At this stage I’d like to see two more quarters of in line financial management and continued progress in line with their initial timelines. This’ll also cover the initial 12 month escrow period put in place for the initial investors which will be interesting to see who in the Top20 will stay/go.

By then the company is still very high risk but would of shown enough progress, for me personally to take an initial position.

Please note this initial position is similar to riding a bike down the steepest hill in your town with one eye closed.

Apologies this piece went longer than expected. 

Company

Inoviq (IIQ), previously known as BARD1 Life Sciences Limited (BD1), are a company focused on developing products for early cancer detection. They have multiple products in various stages from initial research to in market (and revenue generating).

Product

In a similar field to BCal, IIQ have two products;

1. SubB2M-BCM
2. BARD1-Breast2

SubB2M- BCM:

This is a blood test targeting, currently, monitoring of existing breast cancer (amongst other cancers). There is some wording around expanding the test to serve as a diagnostic test but currently it appears to be in market and targeted toward post identification monitoring.

Based on the above then the product, currently, is different enough from the BCal test to not be a current direct competitor product. However the company clearly has the intent to expand too early detection in the future with an indicative timeline to commercialisation of mid/late 2023. This is in the same calendar year that is being targeted by BCAL.

BARD1-Breast2

This appears to be the next stage of the above test but with a different research partner. Currently in the research phase. I'll update this straw once I confirm further data.

Summary

There is local competition.

But the competition isn't as focused as BCAL (one product V multiple).

The race is on!

Announcement released back on 11 Jan.

BCAL have appointed Dr John Hurrell. Recently from JanaCare (remote chronic disease patient management) and Focus Diagnostics (subsidiary within Quest Diagnostics involved in the development and launching of 70 diagnostics tests).

The good doctor will be responsible for the management of the laboratory work locally and will drive the preparation of product launch within the US (due for late 2023, early 2024) which is due to follow a prior AUS launch.

He's coming in hot with a $300k pay packet plus STI and LTI running from 2022 through to 2025.

Does that seem like a lot for a company less than one year into public life? Yes?

Would I, personally, have preferred a lower pay packet and higher incentive allocation? Yes.

If he's successful in his goals, will it really matter? Probably not.

Really the bone of contention for me is the limited funds (currently 12 quarters remaining) in the coffers to get the product to commercialisation (sweet sweet revenue). With the goal of sales starting at end of 2023 it still get's there with some space to spare which is great compared to some other companies where you can see miles of daylight between were the funds run out and when the dollars are due to start coming in.

Keen on any thoughts from the group

BCAL Diagnostics are endeavouring to commercialise, initially, a blood test to be administered in parallel with mammogram screening to either support or dismiss the identification of breast cancer prior to the biopsy stage. 

@poohbear has a great summary on BCAL’s history below and I would recommend any readers give that post a once over to further understand where BCAL is coming from. 

The focus of this post is more, what is the pathway forward, what are the key milestones for the company. 

As always, open to any and all commentary, thoughts, corrections etc on any of this. This is very much a layman’s interpretation of what information I could find and my initial thoughts on it. I am as far removed from a subject matter or sector matter expert or even experienced journeyman.

Taken from the BCAL Investor Presentation are the following timeline items. I’ve added some notes to each one. Part of this is explanatory for anyone having a brief look at BCAL. The other is for my own reference later down the line for when I’m wondering why the SP has suddenly skyrocketed or what it means when a milestone is not achieved or falls into an extension loop which can happen to early stage med companies. 

• Clinical Study 1 Stage 1 - 2021 / 2022
  • Purpose - Establish Feasibility of the test and develop a workflow (i.e how would the test factor into the whole process of testing for cancer).
  • Risk - The test isn’t feasible from a results, time or cost perspective. The company could languish in this stage until it figures out this step.
• Clinical Study 1 Stage 2 & Study 2 - 2022 / 2024
  • Purpose - Assess the information drawn from stage 1. Track the participants over a period of time to track for recurrence.
  • Risk - Despite sorting the workflow, cost and timing of the testing. The accuracy may not hold up in the larger participant sizes. Less accuracy, less interest. 
• Regulatory (AUS, EU, USA) - Mid 2021 / Mid 2024
  • Purpose - As stated. 
  • Risk - My thoughts on this are somewhat split. And it’ll be dependent on the outcome of the Study’s. 
    • Firstly - Commercialising the product needs the regulatory backing. No stamp, no sales.
    • Secondly - We may get the stamp but if the results of the Study’s are lower than expected then does it carry less weight. The company can sell in the market but do we struggle with sales once perspective clients take a closer look. 
• Laboratory Developed Test - Mid 2022 / Mid 2024
  • Purpose - To be honest I can’t speak on this item with any level of confidence. It appears to be the actual creation of the physical test element itself (done by BCAL’s partner IZON).
  • Risk - I would assume that without an LDA but all other boxes ticked then we have a product that can do what it says but can’t be replicated and used with ease across the market.
• Launch Product 1 (Mammogram Adjacent) - Late 2023 / 2024 Plus
  • To be honest. My thoughts on this will be formed as the previous milestones are addressed. I’ll return to this the closer it gets otherwise it’s just wilder exposition on wilder exposition. 
• Product 2 Development - 2024
  • Per above
• Product 3 Development - Mid 2024
  • Per above

New to the market, listing in July this year, BCAL Diagnostics is a wholly Australian-owned biotechnology company based at the National Innovation Centre at Eveleigh. Since its establishment in 2010, BCAL Diagnostics has been striving to revolutionise early detection and screening for breast cancer for women. Over the past decade BCAL has developed a non-invasive blood test for the detection of breast cancer, with results to date demonstrating 91% specificity and 87% accuracy. The BCAL test is a lipid biomarker blood test.

With more than two million new cases of breast cancer diagnosed globally each year, a substantial opportunity exists for BCAL to improve patient outcomes.

BCAL has partnered with global integrated cancer care and cardiac provider GenesisCare to conduct clinical research required for regulatory approvals across several jurisdictions, commercialisation and market entry points.

They have successfully secured patents in Australia and Japan. BCAL has an exclusive global license to the blood testing technology from the University of Louisville (UoL) in the US. They have been working with the UoL over the last three years to secure the patents. In May 2016, the Japanese patent was granted and in September 2016 the Australian patent was granted. Hopefully the granting of the US and Europe patents will follow soon.

In 2017-18, BCAL Diagnostics received support under the NSW Government’s Medical Devices Fund (MDF) and its Commercialisation Training Program. The MDF is an $8.2 million per annum fund which helps to encourage investment in the commercialisation of medical devices and related technologies in NSW.

A small cap company , $20.72m, currently trading at around $0.16 after opening on the ASX at $0.25. I think a company with serious prospects both financially and medically. I’d suggest a reasonable share price at this time around $0.20.