Early results suggest they have a blood test which works effectively as a screening test for lung cancer.

Lung cancer is the leading cause of cancer death in the world and is treatable when caught early.

such huge potential for humanity and for investors…. Probably more for the first than the second but still

ASX Announcement

24 November 2023

Rhythm Biosciences Ltd

ACN 619 459 335

ASX: RHY

www.rhythmbio.com

Australian Registered Address

Bio21 Molecular Science & Biotechnology Institute

30 Flemington Road

Parkville VIC 3010 Australia

T +61 3 8256 2880

E [email protected]

Directors

Otto Buttula Executive Chairman

Sue MacLeman Independent Deputy Chair

Trevor Lockett Executive Director

Rachel David Non-Executive Director

Louis Panaccio Non-Executive Director

Platform Expansion: Lung Cancer Diagnostic Test Update

Highlights

 Preliminary data from the Baker Institute on lung cancer diagnostic test revealed positive outcomes.

 A 5 biomarker-combination has identified above 85% Sensitivity and 90% Specificity.

Rhythm Biosciences Ltd (ASX: RHY) (“Rhythm” or the “Company”) is pleased to provide an update on its cancer

diagnostics technology platform expansion program in lung cancer. As previously announced (ASX: RHY - 15

December 2022), together with the Baker Institute, Rhythm has identified a 5 biomarker combination that

exhibits an effective correlation with various stages of lung cancer.

The preliminary assessment of 17 biomarkers was performed by the Baker Institute in a “research use only”

feasibility immunoassay study to evaluate these blood-based biomarkers from 70 lung cancer patients and 71

healthy volunteers. This preliminary R&D has identified an important biomarker combination that can

distinguish between patients with lung cancer and healthy controls, with >85% sensitivity and >90% specificity

(P ≤0.00001).

Lung cancer stages identified in this study are in the following table.

Lung cancer Healthy control Total

Median Age 61 63

Male | Female 40 | 30 42 | 29

Stage I 16

Stage II 15

Stage III 20

Stage IV 19

Total 70 71 141

The 5-year overall survival rate for Stage 1 lung cancer is approximately 68% from diagnosis, and Stage 2 is at 35%. Survival for locally advanced cancers

(Stage 3) is approximately 17%, while the 5-year survival rate for Stage 4 (metastatic lung cancer) is at 3% – National Cancer Control Indicator (NCCI).

These encouraging results warrant confirmation in a larger population and justify the continuation and

advancement of the project. Therefore, verification of these results would support the case for investment in a

new R&D program to develop, validate, clinically evaluate the performance of the biomarkers, and translate

these results into a commercially scalable, proprietary blood test to detect lung cancer early when it is most

responsive to potentially curative treatments.

About Lung Cancer

Lung cancer remains the leading cause of cancer-related deaths worldwide, primarily because most people

present when the stage is too advanced to offer any reasonable chance of cure.

1 The Australian Institute of

Health and Welfare estimated that in 2022, 14,529 Australians were diagnosed with lung cancer, and more than

8,6064 died from the disease.2 Overall, the 5-year survival rate for Lung cancer is low, at about 22%2 and there

is a clear need to improve the diagnostic tools for screening in detecting early-stage lung cancer.

- ENDS -

Authorisation & Additional Information

www.rhythmbio.com

This announcement was authorised by the Board of Directors of Rhythm Biosciences Limited.

For further information contact us via [email protected] or on +61 3 8256 2880

About Rhythm Biosciences

Rhythm Biosciences Ltd (ASX: RHY) is an Australian innovative, medical diagnostics company aimed at delivering simple, affordable blood

tests for accurate and early detection of cancers. Rhythm is focused on improving patient outcomes through detection at the earliest

possible stage, reducing the global burden of cancer and saving lives.

Rhythm Biosciences is committed to working with likeminded global partners to achieve commercialisation and distribution of these

simple solutions.

The company was founded in 2017 and is headquartered in Melbourne, Australia. For more information, visit rhythmbio.com and follow

the company on LinkedIn and Twitter.

References

1. Burzic A, O’dowd EL, Baldwin DR. The Future of Lung Cancer Screening: Current Challenges and Research Priorities. Cancer Manag Res.

2022;14(January):637-645. doi:10.2147/CMAR.S293877

2. https://www.canceraustralia.gov.au/cancer-types/lung-cancer/statistics

Mr. Otto Buttula

Executive Chairman

Ms. Elena Deak

Chief Commercial Officer

https://www.healthservicesdaily.com.au/sms-plan-to-improve-bowel-screening-participation/3982?utm_source=HSD%20Main%20List&utm_campaign=3285a7e25e-Newsletter_August_02_08_23&utm_medium=email&mc_cid=3285a7e25e&mc_eid=f423500859

Although this article is focused on improving uptake of FOB testing it highlights the problem rhythm might solve. The pain point is patient acceptance which would not be such an issue with a blood test (just add it to the rest of the screening/routine bloods with cholesterol etc).

Lots of blue sky if they can get going with some revenue;

  ASX Announcement

19 June 2023

Rhythm Continues Platform Expansion Program for Other Cancers

Highlights

✓ Rhythm appoints Nexomics, at Peter MacCallum Cancer Centre as its third bioanalytical partner to advance the development program for platform expansion into gastric cancer;

✓ This partnership follows the engagement of Agilex Biolabs (breast cancer) and the Baker Institute (lung cancer);

✓ These appointments cover three of Rhythm’s additional cancer market opportunities identified outside the ColoSTAT® program; and

✓ Short list of candidate biomarkers with potential use in the early detection of breast, lung, gastric, cervical and pancreatic cancers have been identified. These will now be evaluated for the early-stage proof-of- concept research with our bioanalytical partners.

Transformative cancer diagnostics technology company, Rhythm Biosciences Ltd (ASX: RHY) (Rhythm or the Company) is pleased to provide an update regarding the technical feasibility pipeline expansion initiatives / opportunities.

As previously announced, the Company has identified several other critical cancers where it can leverage its diagnostics technology platform and has commenced biomarker identification and feasibility programs for each. In July 2022, Rhythm announced bioanalytical partner Agilex Biolabs and in December 2022 the Baker Institute who are engaged to support the development of the first two cancer programs.

Partnership with Nexomics

Rhythm has further progressed its feasibility programs, now confirming a third bioanalytical partner, Nexomics, at Peter MacCallum Cancer Centre (PMCC), who have been engaged to advance proof of concept R&D for a third cancer program, gastric cancer.

Nexomics provides technical expertise for assessment of new diagnostic biomarkers against a “gold standard”. They offer a broad range of clinical tests for inclusion, safety monitoring, efficacy and exploratory biomarkers analysis using unparalleled access to clinical pathology samples.

PMCC is a world leading cancer treatment and research centre, whose values align with Rhythm’s goal of reducing worldwide cancer burden through early detection. PMCC will focus on feasibility and testing of preferred biomarker combinations with the greatest potential for early detection of gastric cancer.

    Rhythm Biosciences Ltd

ACN 619 459 335 ASX: RHY

www.rhythmbio.com

Australian Registered Address

Bio21 Molecular Science & Biotechnology Institute 30 Flemington Road

Parkville VIC 3010 Australia

T +61 3 8256 2880

E [email protected]

Directors

Otto Buttula Trevor Lockett Rachel David Louis Panaccio Sue MacLeman

Executive Chairman Executive Director Non-Executive Director Non-Executive Director Non-Executive Director

 Dr. Trevor Lockett, Technical Director & Board Member of Rhythm, commented:

“We are truly excited to work with an internationally recongised company such as Nexomics & Peter MacCallum Cancer Centre, that both understands the technology, shares the visions, and sees the significant opportunity to positively impact lives globally. This partnership strengthens our ability to leverage strong bioanalytical expertise to assess options for advancing our technology platform, while in parallel, the Company focuses its internal resources on accelerating our initial entry for ColoSTAT into international markets. We are looking forward to working with Nexomics to potentially identify an early screening test for gastric cancer in the future.”

- ENDS -

Authorisation & Additional Information

This announcement was authorised by the Board of Directors of Rhythm Biosciences Limited.

For further information contact us via [email protected] or on +61 3 8256 2880: Mr. Otto Buttula Dr. Trevor Lockett Mr. Paul Smith

Executive Chairman Technical Director CFO & Company Secretary

About Rhythm Biosciences

Rhythm Biosciences Ltd (ASX: RHY) is an Australian innovative, medical diagnostics company aimed at delivering simple, affordable blood tests for accurate and early detection of cancers. Rhythm is focused on improving patient outcomes through detection at the earliest possible stage, reducing the global burden of cancer and saving lives.

Rhythm Biosciences is committed to working with likeminded global partners to achieve commercialisation and distribution of these simple solutions.

The company was founded in 2017 and is headquartered in Melbourne, Australia. For more information, visit rhythmbio.com and follow the company on LinkedIn and Twitter.

About ColoSTAT®

Colorectal cancer (CRC), also referred to as bowel cancer, is the second leading cause of cancer deaths globally. If diagnosed early, colorectal cancer is curable.

The ColoSTAT® Test-Kit is Rhythm Bioscience’s simple blood test for the detection of CRC. It measures five specific protein biomarkers that indicate the likelihood presence of CRC. The test can be used as an alternative for individuals who are unable or unwilling to participate in current screening programs.

The ColoSTAT® Test-Kit is based on research from Australia’s CSIRO and is patent protected internationally. It has the potential to play a key role in reducing the mortality rate and healthcare costs associated with colorectal cancer.

About Nexomics

Nexomics (powered by Peter MacCallum Cancer Centre) provides technical expertise for assessment of new diagnostic biomarkers against a “gold standard”. They offer a broad range of clinical tests for inclusion, safety monitoring, efficacy and exploratory biomarkers analysis using unparalleled access to clinical pathology samples.

About Peter MacCallum Cancer Centre

Peter MacCallum Cancer Centre is a world leading cancer research, education and treatment centre and Australia’s only public health service solely dedicated to caring for people affected by cancer. We have 3,300 staff, including more than 750 laboratory and clinical researchers, all focused on providing better treatments, better care and potential cures for cancer.

    www.rhythmbio.com

A test with this sensitivity and specificity described is definitely superior to the currently used faecal occult blood testing which from personal experience working in hospitals is far more likely to pick up haemorrhoids than colorectal cancer.

The potential market is massive and would likely be attractive to government health care as cost effective (ie resection of early stage colorectal cancer would be cost effective compared with multiple surgeries, chemotherapy etc).

Would reduce endoscopy costs (and waitlists) which are enormous (Day procedures are expensive to run).

Two areas for me that could make or break the investment case here:

1) The cost charged for the test (ie revenue) versus administration costs, middle men etc. What actually flows to the bottom line?

2) Competitors? I am aware of several colorectal cancer tumour markers but not their sensitivity and specificity for CRC.

@Muddled@LifeCapital@Vandelay Any thoughts?