Q4 FY24 Quarterly Investor Presentation & Webinar
Released
Released
Announcement PDF
ASX Announcement
25 July 2024
Q4 FY24 Quarterly Investor Presentation & Webinar
Microba Life Sciences Limited (ASX: MAP) (“Microba” or the “Company”) is pleased to provide below its Q4 FY24 Investor
Presentation and Investor Webinar with CEO Dr Luke Reid and SVP, Therapeutics Prof. Trent Munro presenting.
Quarterly Investor Presentation Webinar
Presenting: CEO, Dr Luke Reid and SVP, Therapeutics Prof. Trent Munro
Webinar Access: The Quarterly Investor Presentation Webinar can now be accessed on demand via Microba’s Investor Hub
at the following link https://ir.microba.com/link/aP3zxr
Investor Q&As
We invite investors and interested parties to submit questions on the Quarterly Investor Presentation & Webinar through
the ‘Ask a question’ section of Microba’s interactive investor platform by following this link: 'Ask a question'
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
.
JOIN MICROBA’S INTERACTIVE INVESTOR HUB
Visit ir.microba.com/welcome for Microba’s interactive Investor Hub
Microba Life Sciences Ltd ABN 82 617 096 652 | Level 10, 324 Queen Street, Brisbane QLD 4000 Australia | 1300 974 621
Combating disease through
the microbiome
Q4 FY24 Results
ASX: MAP
25 July 2024
Authorised for release by the Board of Directors
Disclaimer
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accuracy, reliability or completeness of this Presentation.
2
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
* 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
symptoms*
3
Microba is a medical diagnostic and clinical stage therapeutics
company unlocking the human microbiome
•
Microba was founded in late 2017 on world-leading metagenomic
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
4
5
Q4 Results
Financial Highlights
Q4 Financial Highlights
6
Record Sales and Revenue Growth in Australia, First Full Half of Revenue from Invivo
Clinical in the United Kingdom
$12.09m full year revenue, up 123% YoY | $4.81m Q4 revenue, up 113% YoY
Full Year Revenue growth
(A$m)
Q4 Revenue growth YoY
(A$m)
Q4 Revenue growth QoQ
(A$m)
123%
113%
20%
4.81
4.81
12.09
•
$4.81m in Q4 FY24
unaudited revenue, up
20.2% QoQ and 113%
YoY.
•
$3.95m in Q4 Personal
Testing & Supplements
revenue, up 24.0% QoQ
and 208.8% YoY.
•
$4.66m in Q4 FY24 cash
receipts, up 15.7% QoQ
and up 275.4% YoY.
•
$12.44m Full Year cash
receipts, up 148.1% YoY.
•
$12.09m in Full Year
unaudited revenue, up
123.1% YoY.
4.00
5.42
9.46
+208%
2.26
3.95
+209%
3.95
+24%
3.18
1.28
3.07
2.35
2.63
FY23
FY24
+12%
0.98
0.86
Q4 FY23
Q4 FY24
-12%
0.82
0.86
Q3 FY24
Q4 FY24
+5%
Q4 Financial Highlights
7
Strong growth in Microba’s core personal testing revenue
Full Year Revenue growth
(A$m)
4.85
50%
4.61
3.07
Research services
revenue
2.35
2.63
FY23
FY24
New United Kingdom
revenue
50% growth YoY
From core Microba
personal testing
$4.61m in revenue
from core Microba
personal testing, up
50% YoY
• Accelerating growth of
core personal testing
sales and revenue in
Australia following
launch of diagnostic
testing products,
MetaXplore and
MetaPanel
• Strong growth in clinician
adoption visible through
retained customers,
repeat test referrals and
new ordering clinicians
8
Q4 Results
Business Highlights
Recent Milestones & Highlights
TESTING
1) Record growth for Gastrointestinal Disorder Test,
MetaXplore, in Australia.
-
1,835 tests sold during Q4 FY24, up 71% QoQ.
414 ordering clinicians in Q4, up 41% from 293 in Q3 FY24.
9
THERAPEUTICS
1) Autoimmune Program
Successful completion of world-first
Autoimmune therapeutic discovery
program with Ginkgo Bioworks
2) Invivo Clinical achieved $2.21m in sales for Q4 FY24.
-
$2.21m in sales for Q4 FY24, and $4.45m in sales for H2
FY24.
1,934 tests and 31,833 supplements sold during Q4 FY24,
consistent QoQ
826 ordering clinicians in Q4
3) MetaPanel sales building across major states through the
Sonic Healthcare (ASX: SHL) network.
-
Active KOL engagement
Evidence generation activities and utility publications in
process.
2) Inflammatory Bowel Disease Program
Preparing MAP 315 for Phase 2.
3) Immuno-Oncology Program
Clinical data and sample set grown to
>3,500 patients supporting this
program.
Growing MetaXplore sales
and clinical adoption in Australia
>5,800
2,935
Tests sold since March 2023
60%
Growth HoH
>700
10
723
65%
1,841
Growth HoH
H2 FY24
MetaXplore test sales volume
Australia
•
>300 new clinician accounts registered
to access in Q3, now totals >1,700
registered
•
414 ordering clinicians in Q4,
up 41% QoQ.
•
Growth activities:
- Targeted sales and marketing
activities focused on high
prescribing potential clinicians
- Clinician education
- KOL engagement
- Utility studies and publications
436
181
H1 FY24
1,835 tests sold during Q4 FY24,
up 71% QoQ.
Clinicians have ordered at 30 June 2024
984
H2 FY23
•
H2 FY23
H1 FY24
H2 FY24
MetaXplore ordering clinicians
Growing MetaPanel sales, advancing
GI pathogen diagnosis in Australia
11
•
Doctor referrals and sales continue to
grow monthly across the country,
focused around the major east coast
states New South Wales, Victoria and
Queensland.
•
7 clinician launch events held spanning
all major states and territories
•
Growth activities:
- Targeted sales and marketing
activities focused on
gastroenterology specialists
and general practice
- Clinician education
- KOL engagement
- Utility studies and publications
Australia
Preparing for growth in the United Kingdom
1,934
6,615
Q4 Tests Sold
Tests Sold FY24
31,833
125,767
Q4 Supplements Units
Supplements Units Sold FY24
826
6,958
Q4 ordering clinicians
Clinicians registered all time
United Kingdom
•
$4.45m in sales generated in H2 FY24. The
first full half of Invivo sales and revenue as
part of the Microba group.
•
Growth strategy:
Stage 0
- Bolster sales and marketing resourcing
for the UK team with recruitment of new
talent to unlock latent growth potential
- Recruitment well advanced with great
candidate pool
Stage 1
- Launch Microba’s MetaXplore product
into the UK to drive testing growth
- Planning is well advanced
- Scheduled to occur in FY25.
12
Therapeutic Development Programs continue
to make significant advancements
Core
Program
IBD
(Ulcerative
Colitis)
Discovery
R&D
Preclinical
Phase 1
Phase 2
•
Autoimmune Program
- Successful completion of world-first
Autoimmune therapeutic discovery
program with Ginkgo Bioworks
•
Inflammatory Bowel Disease Program
- Preparing MAP 315 for Phase 2.
- Bolstering CMC package and regulatory
documentation for IND
•
Immuno-Oncology Program
- Clinical data and sample set grown to
>3,500 patients supporting this program.
Undisclosed
(LBP)
MAP 315
(LBP)
Immunooncology
Undisclosed
(LBP)
Autoimmune
Undisclosed
(LBP)
13
14
Microba Diagnostics
15
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.
16
Our Diagnostics Focus
Patients suffering from Gastrointestinal Disease
Neuro
Cardiovascular
Gastrointestinal
→
Oncology
Longevity
Fertility
Lower Gastrointestinal Disease
17
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
18
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
Addressing the GI symptom challenge
19
Microba’s comprehensive diagnostic products
First line
For the detection
of pathogens causing
GI symptoms
Gastrointestinal pathogen test
Developed with
Launched March 2024
Stool DNA test.
175 targets.
Expertly curated clinical recommendations for targeted treatment.
Second line
For identifying
functional causes
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
20
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
Transforming standard of care
21
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
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”
22
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.”
23
MetaXplore
patient
A multi-billion dollar market opportunity
24
Diarrhoea Immuno-compromised
0.7M* patients
35M+
US patients*
Diarrhoea
Immuno-competent
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
***
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
25
Guidelines
Microba’s Therapeutics
27
Our Therapeutics Vision
To combat disease through microbiome health
Since 2020, following the establishment of the richest Microbiome
data resource in the world, Microba has advanced the discovery
and development of novel microbiome therapeutics at the
forefront of microbiome drug development.
27
28
Our primary Therapeutic Focus
Oncology
*
Neuro
Cardiovascular
Gastrointestinal
Allergy
Autoimmune
→
Clinical: Patients suffering from Inflammatory Bowel Disease
*
*
Preclinical: Patients suffering from autoimmune disease, allergy or
undergoing cancer immunotherapy
28
29
Microba is Pioneering an Advanced AI/ML Approach
For the Development of Next Generation Precision Live Biotherapeutics
Target Prediction
Disease Relevant Activity
Disease
Prevalence
Donor
Isolation
Human Data
Driven
Precision
Microbiome
Therapeutics
AI & Machine
Learning
Health Data
Biome Data
Species
Identification
>60,000 metagenomes*
>1,000 health indicators/participant
>1M Genomes
>100M Genes
>100K species
*Derived from both internal and external data
In Silico Analysis
Supportive
Bioactivity
>100TB of DNA data
8,000B alignments
200M CPU hours processing time
20K vCPUs, 50TB RAM
>9,000 isolated strains
>500 species isolated in total
>200 previously uncultured species isolated
1 Phase II ready asset
Multiple pre-clinical leads
29
30
Microba is a leader in Precision Microbiome Therapeutics
Core
Program
IBD
(Ulcerative
Colitis)
Immunooncology
Autoimmune
Discovery
R&D
Undisclosed
(LBP)
MAP 315
(LBP)
Undisclosed
(LBP)
Undisclosed
(LBP)
Preclinical
Phase 1
Phase 2
Development
partners
•
Precision microbiome analysis
platform delivering unparalleled
accuracy, coverage & depth.
•
Data driven discovery
platform utilising one of the
world’s most advanced & highly
curated microbiome datasets.
•
Potent and novel biology
mediated by Live Biotherapeutic
strategy
•
Demonstrated scalable GMP
manufacturing process
•
Oral delivery and Excellent
safety profile
Leadership experience
30
Autoimmune Program
Stage 2 Screening – Complete June
2024
31
Observed broad and potent immunomodulatory activity
which is disease relevant
Delivered compelling biological
activity enabling selection of 6
lead strains, generating new
therapeutic intellectual property
assets for the Company
Data generated showing impact
on fibrosis, gut barrier integrity,
nuclear receptor biology, GPCRs
and ER stress
Generated more than 3 million
data points in world-first
microbiome therapeutic
discovery effort
31
Oncology Program
Microba’s clinical data and sample set has now grown to over 3,500 patients.
•
>2,500 patient samples collected from the national PrOSPeCT study which is expected to be one of the
largest clinical specimen resources with respect to the microbiome and cancer treatment expected to
support the lead candidate selection decision processes and the pre-clinical package.
•
>1,000 metagenomics samples already analysed from 8 internally recruited and published studies
across multiple cancer types have been complied to discover gut microbiome signatures associated
with patient response to checkpoint inhibitor immunotherapy
•
Robust signals have been discovered spanning geography, clinical indication, and checkpoint inhibitor
regimens, enabling high-throughput in vitro screening of potential lead species for disease-relevant
activities in human immunological models
32
OMICO & PrOSPeCT
study
•
Microba is a
collaborating partner in
the landmark $185M
program, which is the
largest precision
oncology and cancer
genomics initiative in
Australia
•
Microba has joined
companies which as
Bayer, Illumina and
Sonic Healthcare to
advance precision
oncology
Results of integrated machine learning analysis of clinical datasets, demonstrating a consistent metagenomic signature of patient response to ICI.
Models were trained on species abundances using ten-fold cross validation. Final models predict response with an accuracy of 87%.
32
Inflammatory Bowel Disease Program: MAP 315
Data supporting MOA
Phase II trial readiness
Study start timing actively being defined - Adaptive
Patient Study, N = 140 to 200 examining induction of
remission
•
Phase 1 data package = complete
•
Protocol development = complete
•
Final CMC pack = in process
•
IND filing = drafting
Pre-clinical data supports that MAP 315
stimulates mucosal healing (modulation of
WNT signaling, restoration of gut barrier
integrity) and immune homeostasis
(induction of regulatory T cells). Both
critical to the etiology and
pathophysiology of Ulcerative Colitis
MAP 315 induces
regulatory T cells
MAP 315 ameliorates IFNγ induced loss of gut barrier
integrity and restores WNT pathway signaling
✱✱
✱✱✱✱
Treg Induction
Expression
✱
Expression
Integrity (TEER)
✱✱
33
Phase I trial summary – Concluded Dec 2023
Safe and well tolerated at both low and high
doses
No clinically significant safety signals from
assessments.
Faecal kinetics assessed by metagenomic
analysis indicated ability to successfully deliver
live MAP 315 into the gastrointestinal tract
33
Therapeutic pipeline & catalysts
Therapeutic pipeline & catalysts
Core Program
IBD
(Ulcerative Colitis)
Discovery R&D
Undisclosed
(LBP)
MAP 315
(LBP)
Preclinical
Phase 1
Phase 2
Upcoming
Milestone
Phase 2 IND
submission
Immuno-oncology
Undisclosed
(LBP)
Lead
candidate
selection
Autoimmune
Undisclosed
(LBP)
Animal
model data
• Live Biotherapeutic Product (LBP)
Development
Partners
35
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
37
Appendix
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
38
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
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
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
3 therapeutic programs.
2 channels to market.
PATHOLOGY PARTNER CHANNEL
39
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
Microba is developing the 3rd Generation of Microbiome Therapeutics
using a human data driven approach
1 First Generation
Faecal Doner Derived & FMT
2 Second Generation
Bacterial Consortia
FDA approval Nov 30 2022
Faecal doner derived enema
drug product
Vedanta Biosciences
Vedanta Biosciences Raises
$106.5M in Funding
FDA approval April 27 2023
Faecal doner derived oral
capsule drug product
SER-155
Phase Ib showing engraftment
reduction in pathogens
40
3 Next Generation
Single Strain & Small Molecule
Microba
MAP 315 Phase I IBD
Advancing oncology &
autoimmune pipeline
40
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