Heart in Mouth...

Rhythm in a trading halt today... hopefully this means TGA approval. Expect a significant SP drop if there's a problem with that approval.

The trading halt is requested pending an announcement to be made by the Company to the market in connection with the Therapeutic Good Administration submission (“purpose”).

In accordance with Listing Rule 17.1, the Company provides the following information in relation to the request:

1. The trading halt is necessary to assist the Company in managing its continuous disclosure obliga- tions as the Company expects to make a material announcement to the market for the stated pur- pose.
2. The Company requests that the trading halt remains in place until the earlier of commencement of normal trading on Friday 3rd March 2023, or when the announcement regarding the purpose is re- leased to the market.
3. The Company expects to make the announcement to the market before the commencement of normal trading on Friday 3rd March 2023.
4. The Company is not aware of any reason why the trading halt should not be granted or of any fur- ther information necessary to inform the market about the trading halt.

RHY released a new investor presentation this morning which caused a little bounce in the SP after a couple of weeks of slow decline. Interesting to note that their language on TGA approval has shifted to "imminent". I optimistically read that to mean they must really be getting close after the pain there have felt from the mixed messages from previous announcements.

Not much else new in their presentation, they've added some detail and nuance to some of their marketing but the essence of the investment case remains the same. They continue to only give broad guidance on sale price of the test (presumably for competitive reasons at this stage). Fingers firmly crossed for TGA approval and the announcement of first revenue later this year.

RHY AGM today which I haven't fully caught up on but seems like no new news. Submission still with TGA as expected...

While all the regulatory assessments need to make, it does seem like the granting of approval is incredibly likely in the next couple of months. These things should never be regarded a formality but it's in that direction I believe.

You'll remember the opportunity here is to replace the current screening for colorectal cancer - the FIT (Faecal Immunochemical Test) with a simple blood test. People don't like the FIT and despite it being delivered free of charge to everyone when they turn 50 (in Australia) usage is stuck in the mid 40%. Not only is the RHY alternative easier and simpler (straightforward blood test), it is also much more accurate and dramatically will lower false positive outcomes from FIT testing.

Share price is definitely meandering before TGA approval. Work underway on approvals in other jurisdictions. TAM is obviously very large globally, though many questions remain about final go-to-market pricing and cost of goods, how they will actually distribute in offshore markets. I remain highly convicted on RHY a significant holding here and 10% of my SMSF.

Following the successful completion of Phase 7 trial, 2 Analysts have updated their valuations for RHY. The full thesis from both is available via the RHY investor page.

MST Access has increased their valuation from $2.90 to $3.10. MST assumes that RHY will command a premium for its test. MST model assumes US market price of A$120 (prev A$100) and for EU and Aus market, A$60 (prev A$50).

Pitt Street Research goes higher and to a wide range of $4.32 - $9.43

Disc: RHY has been difficult to value for me but as many know I am a very bullish long-term holder and have been working on a thesis that has the share price between $3.00 and $4.00 with revenue of $25M and NPAT of $10M (with FCF of around $8-9M) during 2025. Revenue could scale dramatically in the years after that.

Great (and expected) announcement from RHY this morning. SP up 19% at open. The stage is increasingly set for launch.

Disc: Held significantly, deeply biased :)

Highlights

• ✓ Primary Endpoint of the clinical trial successfully achieved;
• ✓ Statistically significant and outstanding performance, recording 81% Sensitivity and a
• Specificity of 91%;
• ✓ All Secondary Endpoints of the clinical trial were successfully achieved;
• ✓ ColoSTAT® was shown to be 35% more accurate than the market standard Faecal Immunochemical Test (FIT) for detecting cancer;
• ✓ ColoSTAT® was shown to be more accurate than the market standard Faecal Immunochemical Test (FIT) for detecting advanced adenomas; and
• ✓ TGA submission remains on track for 1HCY’22.

Transformative, predictive cancer diagnostics technology company, Rhythm Biosciences Ltd (ASX: RHY) (Rhythm or the Company) today announces the statistical analysis outcomes of its clinical trial (Study 7) as verified by Rhythm’s third-party statisticians, for ColoSTAT®, its simple blood test for the detection of colorectal cancer, aimed at global mass-market screening.

• Clinical Trial (Study 7) Outcome
• The clinical confirmed ColoSTAT® exhibited very high accuracy for the detection of colorectal cancer, recording a sensitivity1 of 81% and a specificity2 of 91%.
• Comparison against Faecal Immunochemical Test (FIT)
• Previous ASX announcements of testing outcomes demonstrated ColoSTAT® to be 33% more accurate than the current market standard Faecal Immunochemical Test (FIT).
• Pleasingly, the clinical trial (Study 7) has not only confirmed this performance but in fact increased to demonstrate that ColoSTAT® is 35% more accurate than the globally adopted FIT for detecting colorectal cancer.
• Further, the trial also showed ColoSTAT® to be more accurate than FIT at detecting advanced adenomas.
• ColoSTAT® was not directly related to any adverse events recorded, all of which were classified as minor.

Rhythm CEO and Managing Director, Glenn Gilbert, commented:

“We are extremely pleased with the significant positive outcomes from this study. It further supports our conviction that ColoSTAT® has the potential to transform the way colorectal cancer is detected, on a global scale. We express our gratitude to the patients and thank our partners for the work completed thus far, including our Clinical Research Organisation, Accelagen, our statisticians, Statistical Revelations, the individual trial sites and our analytical testing partner Sonic Clinical Trials (a 100% owned subsidiary of Sonic Healthcare ASX: SHL). To achieve such a strong overall performance result and further, the meaningful clinical significance versus the current market standard, FIT, further strengthens Rhythm’s position for significant positive outcomes moving forward, both economically and socially”.

The formal closure of the final clinical trial site, completion of the clinical study report and collation within the technical file are all underway. Subsequently, final submission of documentation for approval to the Therapeutic Goods Administration (TGA) by 1HCY’22 remains on track.

Rhythm will continue to provide further progress updates in due course.

Exec Chairman (Otto Buttula) and CEO (Glenn Gilbert) hosted the call.

Rhythm's initial product, ColoSTAT® is a simple, low-cost blood test for the early detection of colorectal cancer for global mass-market screening. IP protection secured in all major international jurisdictions.

Not much new, call was brief (25 minutes)

Topics covered:

Big Picture

The vision is that ColoSTAT becomes part of standard range of blood tests for +45 years old. Empasised the simplicity of the end-to-end testing and reporting process. And the fact that ColoSTAT can integrate with all major existing pathology machines. Belief that more people will screen with blood test as part of routine testing and therefore bowel cancer detected earlier.

Trial 7 - the final test for Regulatory Approval - extremely confident that Test 7 will meet all requirements for regulatory approval. All blood tests completed and data entered. Statistical analysis is underway and drafting is underway. TGA filing will occur this half.

Expansion possibilities - the bio-markers being used in ColoSTAT are also applicable to screening or other cancers - breast, pancreatic, lung, gastric and cervical. Believe that they can accelerate from existing platform to accurate blood testing for these additional cancers in short time periods, months to proof of concept.

TGA submission will happen first half, already closely connected to studies, no concerns about gaining approval, have to work the process.

CY'22 Catalysts

• Clinical Trial (Study 7) results and clinical study report completion;
• Technical file complete for ARTG listing for TGA submission and approval;
• Identify and progress partnering / commercialisation deals (Domestic and International);
• International country submissions / registration updates;
• Advance platform technology expansion program (progress updates); and
• Target first revenues late CY'22.

Questions

Are there expectations to raise further capital? "not at all"

Can you tell us about partner discussions underway? "Talking with companies in varying stages in every significant jurisdiction. Well known names that you would expect."

Where first? Think US with Clearlab might be first.

Any indications of test pricing? We've typically been using $50. PSA test is $40 reimbursed in Australia at the moment but ColoSTAT more accurate than the PSA test. Think pricing will be variable - government pricing at high volumes may be lower. Partly competing with colonoscopy at multiple thousands - ColoSTAT potential pre-screening before colonoscopy which interests health insurers. Making significant progress on cost of goods.

2 announcements from RHY today:

first confirming the extension of their CE mark into Great Britain for ColoSTAT which is an important regulatory hurdle.

"The Company has demonstrated that ColoSTAT® fully conforms with the regulatory requirements for IVD products under the European Directives for IVD Medical Devices (98/79/EC).

Europe and UK Commercial Opportunity

Achieving regulatory milestones with this recent CE Mark expansion, provides clear intent for the Company’scommercial plan and market entry strategy. Europe and the UK represent a significant addressable screening population for ColoSTAT® of over 231 million people, with a potential combined value of ~US$12 billion."

Secondly, announcing an institutional placement of shares raising $6.53M to a "Global Institutional Funds manager"

About the Placement

New Shares to be Issued: 4,666,179

Issue Price of New Shares: $1.40

Amount Raised: $6,532,650.60

Share Placement Of $6.53M To Global Institutional Funds Manager

Highlights

• ? Rhythmraisesapproximately$6.53m,beforeassociatedcosts;
• ? ExclusivePlacementtoasingle,global,institutionalfundsmanager;
• ? Placement price of $1.40 represents a modest 6% discount to last closing price of $1.49;
• ? Funds raised will be used to accelerate both global commercial market entry activities for ColoSTAT® and development of additional cancer diagnostic targets; and
• ? Substantiallyextendscashrunwayintolate2023,excludingcommercialrevenuegeneration which is expected to be achieved within the period.

In a sea of red ink in my SMSF this morning, RHY is trading up over 6% at $1.59.

DISC: Held significantly here and in my SMSF

Positive announcement this morning from RHY and stock has opened 12% up on granting of CE mark for ColoSTAT. This regulatory approval wasn't ever at risk but this is a very important milestone and an important step in RHY's move to selling their product.

Highlights

CE Mark Granted for ColoSTAT®

? Rhythm confirms CE Mark certification is complete for ColoSTAT®;

? CE Mark certification delivers a major milestone allowing ColoSTAT® to be marketed and sold within the European Economic Area (EEA); and

? Enables access to an addressable market of 231 million people, valued at ~US$12 billion.

Transformative cancer diagnostics technology company, Rhythm Biosciences Ltd (ASX: RHY) (Rhythm or the Company) is pleased to confirm the achievement of a major regulatory milestone for the commercialisation of ColoSTAT®, its simple blood test for the detection of colorectal cancer, aimed at global mass market screening.

Rhythm’s colorectal cancer detection technology product, ColoSTAT®, has been granted CE Mark and fully conforms with the European Directives for IVD Medical Devices (98/79/EC). This critical regulatory achievement is a result of robust and stringent analytical testing and adherence to design and development procedures as per the Essential Requirements.

New investor presentation released today from RHY capturing their significant progress to date. SP up 12% at time of writing today, closing in on their record highs. Suspect a reaction from those not so familiar with the RHY story that TAM is in the vicinity of $40B. RHY is today a 1000% gain in my SMSF so I'm a massive fan. I had been inactive all that time here in SM so bought in late in my SM portfolio but very confident it will go beyond 100% here. Probably about time to try and get a proper valuation on the stock I guess.

Very strong market reaction from RHY's announcement today about test kit quality.  Progress being made on regulatory approvals.  I remain very bullish on RHY, getting closer and closer to going to market.

Commercially Manufactured ColoSTAT® Test Kits Deliver Consistent, High Accuracy Outcomes - Equivalent To Study 6

Highlights

? Ongoing testing of commercially manufactured ColoSTAT® test-kits continues to confirm high accuracy, significantly outperforming the current market standard testing regime; and

? Provides positive backdrop as Rhythm advances Regulatory processes and commercialisation.

Transformative cancer diagnostics technology company, Rhythm Biosciences Ltd (ASX:RHY) (Rhythm or the Company) is pleased to provide an update on its progress toward the commercialisation of ColoSTAT®, a simple, low-cost blood test for the detection of colorectal cancer, aimed at global mass market screening.

Continued Testing Drives Further Confidence

Rhythm has continued to conduct confirmatory testing on its commercially manufactured ColoSTAT® test kit following successful completion of Study 6 in March 2021, which demonstrated a 33% higher accuracy than the current market standard Faecal Immunochemical Test (FIT) used globally. Consistent and reproducible results, equivalent to the exceptional Study 6 outcomes of 84% Sensitivity1 and 95% Specificity2 (refer 16 March 2021 ASX Announcement), have been observed which provide high confidence in Rhythm’s cancer diagnostics technology as the Company progresses market entry activities with respect to regulatory submissions and finalisation of the Clinical Trial.

The approval process is advancing with the Therapeutic Goods Administration (TGA) for filing an Australian Register of Therapeutic Goods listing, which is the final step in achieving regulatory approval in Australia. Rhythm also remains on track for European approval, with CE Mark submission and approval due to be completed by the end of CY2021. This recent confirmatory testing is designed to support the requirements for CE Mark submission.

A final Study Report is underway to finalise the Clinical Trial after the completion of the patient recruitment phase last month. This Report is targeted for delivery in 1H CY22.

Commenting on the testing progress, Rhythm CEO, Glenn Gilbert said:

“Our visible path to market is emerging as our ongoing testing program continues to provide the Company with confidence moving through the regulatory phase. The high accuracy of our cancer diagnostics technology has the potential to deliver positive outcomes for millions of people around the world. This is an exciting time for all stakeholders as we focus on the massive global market opportunity ahead of us.”

1Sensitivity is the ability of the test to correctly identify those patients with colorectal cancer, that is, the percentage of people with colorectal cancer who are correctly identified as having illness.

2Specificity is the ability of the test to correctly identify people who do not have colorectal cancer, that is, the percentage of people without colorectal cancer who are correctly identified as not having cancer.

Disc:  Happy holder of RHY

Rhythm's price has bounced back the positive side of $1.00 the last few days on the back of the over subscribed rights offer at $0.85 and news that regulatory approvals are progressing as expected.

TGA Accepts Initial Regulatory Documentation

• Manufacturers Evidence documentation for TGA approval accepted;

• Recruitment completion for clinical trial (Study 7) imminent; and

• Achieves another important step for Australian regulatory approval.

  Rhythm Biosciences Limited (ASX: RHY) is pleased to announce that the Therapeutic Goods Administration (TGA) has formally accepted Rhythm’s Manufacturers Evidence documentation. This documentation is required for approval in Australia for ColoSTAT® and completes the first step for regulatory approval in Australia.

  ColoSTAT® is aimed to be a globally marketed, low-cost, simple blood test for the early detection of colorectal cancer for mass-market screening.

• As previously outlined, the TGA submission process will require two key steps, consisting of filing both the Manufacturers Evidence documentation (submitted and now accepted) and filing for an Australian Register of Therapeutic Goods (ARTG) listing. The ARTG listing will contain further comprehensive documentation such as the product technical files, clinical evaluation reports and similar.

  Commenting on the TGA’s formal acceptance, Rhythm CEO, Glenn Gilbert said:

  “Progress for regulatory approval in Australia has commenced and it is pleasing to have received the TGA’s acceptance of our Manufacturers Evidence. Our expectation remains that patient recruitment for the clinical trial (Study 7) is to be completed in the near term.

  Again, the application for a CE Mark for European approval is independent of both the clinical trial (Study 7) being completed and TGA application. CE Mark filing remains on track for late this calendar year.”

For those new to RHY:

About Rhythm Biosciences

Rhythm Biosciences (ASX: RHY) is a transformative, predictive diagnostics company, specialising in early cancer detection. Rhythm’s initial business pursuit is centred upon technology originally developed by the CSIRO and involves the development and commercialisation of a screening and diagnostic test for the early detection of colorectal cancer, the third biggest cause of cancer-related deaths globally.

Rhythm’s lead product, ColoSTAT®, is intended to be a simple, affordable, minimally invasive and effective blood test for the early detection of bowel cancer for the global mass market. It is expected to be comparable to, if not better than, the current standard of care, the faecal immunochemical test (FIT), at a lower cost. ColoSTAT® also provides an alternative for those who choose not to, or are unable to, be assessed using standard screening programs.

ColoSTAT® is designed to be used easily by laboratories without the need for additional operator training or additional infrastructure. ColoSTAT® has the potential to play an important role in reducing the morbidity and mortality rates and healthcare costs associated with colorectal cancer via increasing current screening rates.

Globally, over 850,000 people die from colorectal cancer each year. Colorectal cancer is typically diagnosed at a later stage when there is a poor prognosis for long-term survival. Annual estimated unscreened 50-74-year old’s is estimated at +130m for the US, EU and AU alone, with this marketpotential being more than $6.5b.

Rights Offer to raise approximately $4.3 million

• Rhythm to undertake a non-renounceable rights issue offer to eligible shareholders on the basis of one (1) new share for every forty (40) shares held at an issue price of $0.85 (85 cents) per new share plus 1 Class A Option and 1 Class B Option for every 2 New Shares subscribed under the Offer to raise up to $4.3 million (“Rights Issue Offer”) before costs.

• Binding commitments received for approximately $2.75 million for any shortfall shares from the Rights Issue Offer.

• All Directors, have indicated that they intend to take up some or all of their Entitlement, representing an investment of approximately $0.62 million.

  30 July 2021, Melbourne: Rhythm Biosciences Limited (ASX: RHY) is pleased to announce it is undertaking a non-renounceable rights issue offer to raise approximately $4.3 million from shareholders (“Rights Issue Offer”) before costs.

  The funds from the Rights Issue Offer will be applied to:

  • Furthering and completing research and development of the current ColoSTAT® test;

  • USA market entry commencement (CLIA lab developed test & FDA route);

  • Commence platform technology research and development program for other

    cancer targets;

  • Completion of the current clinical trial (Study 7) recruitment and preparation for

    regulatory submissions in Europe and Australia (CE Mark and TGA);

  • The scale up of manufacturing capability, including initiating program to transfer

    core technology to more automated machines / platform;

  • Marketing / business development; and

  • Working capital purposes.

• Rights Issue Offer Details

  The Company is undertaking a non-renounceable rights issue offer to eligible shareholders to subscribe for one (1) new shares for every forty (40) shares held an offer price of $0.85 (85 cents) per share plus 1 Class A Option and 1 Class B Option for every 2 New Shares subscribed under the Offer to raise up to $4.3 million before costs by the issue of up to ("Rights Issue Offer"). Eligible shareholders are shareholders with a registered address in Australia or New Zealand as at as at the Record Date of 6 August 2021. There is no minimum amount to be raised under the Rights Issue Offer, but the Company has already received binding written commitments from third parties for up to $2.75 million of any shortfall available (see below).

  Rights Issue participants will be offered attaching, unlisted options, comprising 1 Class A Option and 1 Class B Option for every two new shares taken up.

• Class A Options will have an exercise price of $1.20 and expire on 31 August 2022; and

• Class B Options will have an exercise price of $1.80 and expire on 31 July 2024.

  The Rights Issue Offer will open on 10 August 2021 and close at 5pm (AEST), 3 September 2021. Issues under this Rights Issue Offer will be made under Listing Rule 7.2 exception and therefore do not affect the Company's current Listing Rule 7.1 capacity. No shareholder approval is required for the Rights Issue Offer. Fractional entitlements will be rounded up to the nearest whole number.