Microba Diagnostics Business Update to Bioshares Summit
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Released
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ASX Announcement
12 July 2024
Microba Diagnostics Business Update to Bioshares Summit
Microba Life Sciences Limited (ASX: MAP) (“Microba” or the “Company”) is pleased to announce that Chief Executive
Officer, Dr Luke Reid will present at the 18th Bioshares Biotech Summit in Perth, Australia at 6.55pm AEST/ 4.55 AWST (Perth
time) tomorrow.
Founded on world-leading metagenomic microbiome analysis technology, Microba has been executing on a clear vision for
routine use of clinical diagnostic microbiome testing, and novel effective therapeutics developed using this technology. In this
presentation, CEO Luke Reid will present on the recent launch of Microba’s diagnostic products and next step in its journey as a
medical diagnostics company at the forefront of the clinical application of microbiome testing.
The subject of the Bioshares presentation is ‘Unlocking the diagnostic application of microbiome testing’.
A copy of the Bioshares Biotech Summit presentation is attached below.
This announcement has been authorised for release by the Board of Directors
For further information, please contact:
Dr Luke Reid
Chief Executive Officer
luke.reid@microba.com
https://ir.microba.com/welcome
About Microba Life Sciences Limited
Microba Life Sciences is a precision microbiome company driven to improve human health. With world-leading technology
for measuring the human gut microbiome, Microba is driving the discovery and development of novel therapeutics for
major chronic diseases and delivering gut microbiome testing services globally to researchers, clinicians, and consumers.
Through partnerships with leading organisations, Microba is powering the discovery of new relationships between the
microbiome, health and disease for the development of new health solutions. For more information visit www.microba.com
View this announcement on our Investor Hub: https://ir.microba.com/link/VyEBbe
.
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Microba Life Sciences Ltd ABN 82 617 096 652 Level 10, 324 Queen Street, Brisbane QLD 4000 Australia, 1300 974 621
Unlocking the diagnostic application
of microbiome testing
Bioshares Biotech Summit 2024
ASX: MAP
12 July 2024
Authorised for release by the Board of Directors
Disclaimer
This presentation (Presentation) has been prepared by Microba Life Sciences Limited (Microba).
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2
Microba is a medical diagnostic and clinical stage
therapeutics company unlocking the human microbiome
•
Microba was founded in late 2017 on world-leading metagenomic
microbial genomic and microbiome analysis technology
•
A clear vision for routine use of diagnostic metagenomic testing,
and novel drugs developed using this technology
•
Foundations and initial revenue built through non-diagnostic
testing services with over 50,000 tests sold to date
•
Microba’s Testing business invested to develop 2 diagnostic testing
products:
Gastrointestinal disorder test – Launched Feb 2023
Gastrointestinal pathogen test – Launched March 2024
•
Microba’s Therapeutics business invested in 3 programs:
Inflammatory Bowel Disease – Phase I complete
Immuno-Oncology – Preclinical lead candidate selection
Autoimmune Disease – Discovery
World-class team
TESTING
THERAPEUTICS
3
Unequivocal evidence demonstrates the human gut microbiome
acts systemically and is a critical component of disease
Gastrointestinal
conditions
Nervous
System
Inflammatory
conditions
BCAAs, TMA,
Hexa-lPS
Infectious
disease
Hexa-lPS
SCFAs
Metabolic
disorders
SCFAs
Gut microbiota
produce metabolites
BCAAs, TMA,
Hexa-lPS
SCFAs
2 PubMed search terms "gut microbiome" and "modulate" and "clinical study" and selecting for clinical trials and randomized controlled clinical trials.
Only studies with positive results indicated in the abstracts were selected.
>150
Clinical studies
demonstrating
that microbiome
modulation can
influence disease
outcomes and
symptoms2
4
5
Our Diagnostics Vision
To combat disease through microbiome health
Since 2023, Microba has executed the next step of its journey
into a medical diagnostic company at the forefront of the
medical application of microbiome testing.
6
Our Diagnostics Focus
Patients suffering from Gastrointestinal Disease
Mental
Cardiovascular
Gastrointestinal
→
Oncology
Longevity
Fertility
Lower Gastrointestinal Disease
7
a leading cause of healthcare spend
$269B3,4
37,310,000
$209B1
$219B2
Oncology
Heart Disease
Patients presenting annually in the US
with lower GI abdominal symptoms*
21,500,000
Pain, bloating, other
15,370,000
Diarrhoea
440,000
IBD
Gastrointestinal
Gastrointestinal
Disease
Disease
Annual US Healthcare Spend
1National Cancer Institute website: https://progressreport.cancer.gov/after/economic_burden; 2CDC website: https://www.cdc.gov/policy/polaris/healthtopics/heartdisease/index.html
3Nyrop et al. 2007. Alimentary Pharmacology & Therapeutics. DOI: 10.1111/j.1365-2036.2007.03370.x. 4Park et al 2019. Inflammatory Bowel Diseases. DOI:10.1093/ibd/izz104.
*Assessment of Medicare claims analysis by Veranex including estimated Private and Medicaid numbers extrapolated from the Medicare claims analysis. Combined with IBS diagnosed individual data from Almario et al 2023.
Gastroenterology. DOI:10.1053/j.gastro.2023.08.010 and IBD individual data from Lewis et al 2023. Gastroenterology. DOI:10.1053/j.gastro.2023.07.003 and Weisman et al 2023. Prev. Med. Rep. DOI: 10.1016/j.pmedr.2023.102173.
Half of patients are not getting a resolution
8
from current standard of care
47%
→ Unresolved
53%
Gordon, J., Miller, G., & Valenti, L. (2015). The management of unresolved gastrointestinal symptoms in Australian general practice. Australian Family Physician, 44(9), 621-623..
Resolved
A multi-billion dollar market opportunity
9
Diarrhoea Immuno-compromised
0.7M* patients
35M+
US patients*
Diarrhoea Immunocompetent
14.7M* patients
Non-specific
Lower GI
symptoms & IBS
35.2M* patients
>$15B
US Total Addressable Market**
Symptoms in IBD
0.4M* patients
Ongoing market analysis with
* Assessment of Medicare claims analysis. Estimated Private and Medicaid numbers extrapolated from Medicare claims analysis.
** Assumes minimum revenue per test of US $416.78 aligned to CPT code 57507. This is viewed to be the minimum with the top pricing predicate at US $2126.20
***
Addressing the GI symptom challenge
10
Microba’s comprehensive diagnostic products
First line
Diagnosing
pathogenic causes
of GI symptoms
Gastrointestinal pathogen test
Developed with
Launched March 2024
Stool DNA test.
175 targets.
Expertly curated clinical recommendations for targeted treatment.
Second line
Identifying functional
causes and treatment
options for
non-pathogenic
GI symptoms
Gastrointestinal disorder test
Launched February 2023
Stool DNA + targeted biomarker test.
7 functional GI markers. >28k microbiome markers.
Expertly curated clinical recommendations for personalised treatment.
Getting answers for patients in need
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Closing the gap on GI symptom diagnosis and treatment
Out of 100 patients presenting with lower GI symptoms
24% more diagnoses with
**
19% diagnosed with
*
Standard of Care (PCR +MCS+OCP)
* Large pathology company data from 70,000 tests with 19% positive pathogen detection rate
** Study of first 4 months of MetaPanel test results in clinical practice in Australia
Strong diagnostic performance
12
Highly specific test that enables confident diagnosis
Diagnostic Performance
vs standard of care
Measure
175
Coverage
MetaPanel
Number of pathogen or gene targets on the test
vs
<25
Standard of care*
Sensitivity
0.94 +/- 0.07
Specificity
0.99 +/- 0.01
Positive Predictive Power (PPV)
0.99 +/- 0.01
Negative Predictive Power (NPV)
0.99 +/- 0.01
Ability of a test to identify the presence of a target correctly; (= TP / (TP + FN))
Ability of a test to identify the absence of a target correctly; (= TN / (TN + FP))
Probability that an individual with a positive test result has the target (= TP / (TP + FP))
Probability that an individual with a negative test result does not have the target (= TN / (TN + FN))
Data from 517 blinded samples. Confidence measures represent median values with 95%
confidence interval across pathogen species compared to one or more validated assays.
*Including multiplex PCR & MCS testing
Transforming standard of care
13
A paradigm shift
“After the first 4 months using the
MetaPanel test, 24% of patients have
been diagnosed with a pathogen that
would have been undiagnosed or
experienced delayed time to diagnosis
and resolution.
This is a breakthrough in infectious
disease management”
Dr Michael Wehrhahn
BSc (Med) MBBS (Hons) MPH (Hons) FRACP FRCPA
Clinical Microbiologist,
Infectious Disease Physician & Director
of Molecular Biology
Advancing GI pathogen diagnosis in Australia
• Sales building across all
states through the Sonic
network
• 7 clinician launch events
held spanning all major
states and territories
• Multiple clinical utility
studies initiated
• Initial publications in
process
• Active KOL development
14
Changing lives every day
“Before completing the MetaXplore test with my practitioner, my health was in
constant distress. I looked and felt bloated all the time, to the point of appearing six
months pregnant. My severe constipation led to bowel movements only every 5-6
days with trapped gas causing extreme pain. After completing the MetaXplore test
and implementing my treatment plan, I have experienced remarkable improvements.
My bowel movements are now regular, averaging every 2-3 days. The trapped gas
and extreme pain are gone, significantly improving my daily life. With adherence
to the treatment plan, I no longer suffer from bloating, pain, reflux, or indigestion”
15
MetaXplore
patient
Changing lives every day
“I have struggled with gastrointestinal symptoms for over half my life. I have
tried resolving with many specialists, restrictive eating plans and natural
therapies. My MetaXplore test this year identified clear problems and a
personalised treatment plan. I am grateful that through following the
treatment plan I have achieved complete resolution to my symptoms and
can enjoy eating unrestricted for the first time in 35 years.”
16
MetaXplore
patient
Growing sales in Australia post launch
>5,800
17
2,935
Tests sold since March 2023
60%
1,841
Growth HoH
984
H2 FY23
H1 FY24
MetaXplore test sales volume
H2 FY24
Growing clinical adoption in Australia post launch
723
>700
Clinicians have ordered at 30 June 2024
65%
436
Growth HoH
181
H2 FY23
H1 FY24
MetaXplore ordering clinicians
H2 FY24
18
Serving patients today and driving to establish
a new reimbursed standard of care
Out of pocket
pay access
Driving access today
where standard of care
has failed.
Full out of pocket pay.
Regulatory
Evidence
Clinical performance
validation.
Case studies.
Registry driving RWE.
RCTs vs standard of
care demonstrating
clinical utility.
Reimbursement &
coverage
19
Guidelines
Appendix
20
Patient pathway — Advancing the standard of care for GI symptoms
Colonoscopy for formal
IBD or CRC diagnosis
and treatment
Targeted antibiotic
treatment
New Microba
care pathway
If negative
Current
standard of care
Is it a pathogen
causing these
symptoms?
IBD risk test faecal
calprotectin ELISA
If negative
If positive
Broad spectrum
antibiotic treatment
DGBI
Expect psychogenic IBS.
Referred for mental
health support
Is this a functional
GI disorder or mental
health disorder?
Is there risk of
IBD or CRC?
10-22 pathogen
PCR test
IBD = Inflammatory Bowel Disease, CRC = Colorectal Cancer, IBS = Irritable Bowel Syndrome
If negative
Comprehensive
gastrointestinal
disorder test
175 targets
Patient presents with
GI symptoms.
Functional microbiome
or GI disorder diagnosis
with personalised
treatment plan
If positive
If positive
Broadest pathogen
test available
and
/or
CRC risk test
FIT or FOBT
If negative
IBS Diagnosis by exclusion
+
IBS
If positive
Colonoscopy for formal IBD or CRC
diagnosis and treatment
Non-specific diet and
mental health support
21
Two core business segments driven by a world leading technology
Testing Business
Next generation gastrointestinal diagnostics
2 clinical tests.
GASTROINTESTINAL PATHOGEN TEST
GASTROINTESTINAL DISORDERS TEST
World leading microbiome
analysis technology
Proprietary databank
Advanced AI and biostatistics
powering a diagnostics and
therapeutics platform
Therapeutics Business
Precision microbiome therapeutics
Data driven therapeutic development platform.
ADVANCED AI/ML APPROACH
UNDERPINNED BY WORLD LEADING
TECHNOLOGY
3 therapeutic programs.
2 channels to market.
PATHOLOGY PARTNER CHANNEL
PRIMARY TARGET CLINICIANS
Gastroenterologists
General Practitioners
Other Specialists
DIRECT TO PRACTITIONER CHANNEL
PRIMARY TARGET CLINICIANS
Integrative General Practitioners
Integrative Specialists
Dieticians
Nutritionists
Naturopathic practitioners
NOVEL PIPELINE OF MICROBIOME
THERAPIES – POTENT, ORAL DELIVERY,
SAFE & MANUFACTURABLE
INFLAMMATORY BOWEL
DISEASE PROGRAM
IMMUNO-ONCOLOGY
PROGRAM
AUTOIMMUNE DISEASE
PROGRAM
CLINICAL INDICATION
CLINICAL INDICATION
Multiple cancers to enhance
check-point inhibitor treatment
response
CLINICAL INDICATION
Lupus, psoriatic arthritis &
autoimmune liver disease
Mild-moderate Ulcerative
Colitis
DEVELOPMENT STAGE
Phase 1 Complete
Phase 2 Readiness
DEVELOPMENT STAGE
Pre-clinical. Lead
candidate selection
DEVELOPMENT STAGE
Discovery
22
Dr Luke Reid
Chief Executive Officer
luke.reid@microba.com
CONTACT
Head Office
Level 10, 324 Queen Street
Brisbane QLD Australia
Pasquale Rombola
Chairman
pasquale.rombola@microba.com
Laboratory
Princess Alexandra Hospital
Woolloongabba QLD Australia
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