Dimerix DMX-200 for Chronic Kidney Disease - ASX: DXB Gold Coast Investment Showcase 20 June 2018
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Dimerix
DMX-200 for Chronic Kidney Disease
Gold Coast Investment Showcase
20 June 2018
ASX: DXB
1
Disclaimer
S o m e o f th e in fo rm a tio n in th is p re s e n ta tio n m a y re fe r to D im e rix L im ite d (“D im e rix ” o r th e “C o m p a n y ”) b a se d o n in fo rm a tio n a va ila b le to it a s a t th e d a te o f th is p re se n ta tio n . T h e in fo rm a tio n in th is
p re se n ta tio n is p ro vid e d in s u m m a ry fo rm a n d d o e s n o t co n ta in a ll in fo rm a tio n n e ce ssa ry to m a ke a n in ve stm e n t d e cis io n re g a rd in g D im e rix .
T h is p re se n ta tio n d o e s n o t c o n stitu te a n o ffe r, in vita tio n , so licita tio n o r re co m m e n d a tio n w ith re sp e ct to th e p u rch a se o r sa le o f a n y se cu rity in D im e rix , n o r d o e s it co n s titu te fin a n cia l p ro d u ct a d vice
o r ta ke in to a cc o u n t a n y in d iv id u a l’s in ve stm e n t o b je ctive s, ta xa tio n situ a tio n , fin a n cia l situ a tio n o r n e e d s . A n in v e sto r m u s t n o t a ct o n th e b a sis o f a n y m a tte r co n ta in e d in th is p re se n ta tio n b u t m u s t
m a ke its o w n a sse ssm e n t o f D im e rix a n d c o n d u ct its o w n in ve stig a tio n s . B e fo re m a kin g a n in ve stm e n t d e cisio n , in v e s to rs sh o u ld co n s id e r th e a p p ro p ria te n e s s o f th e in fo rm a tio n h a vin g re g a rd to
th e ir o w n o b je ctive s, fin a n c ia l s itu a tio n a n d n e e d s, a n d se e k le g a l, ta xa tio n a n d fin a n cia l a d vice a p p ro p ria te to th e ir ju ris d ictio n a n d circ u m s ta n c e s . D im e rix is n o t lic e n se d to p ro vid e fin a n cia l p ro d u ct
a d v ice in re sp e ct o f its s e cu ritie s o r a n y o th e r fin a n cia l p ro d u cts . C o o lin g o ff rig h ts d o n o t a p p ly to th e a cq u isitio n o f D im e rix se cu ritie s .
A lth o u g h re a so n a b le c a re h a s b e e n ta k e n to e n su re th a t th e fa cts sta te d in th is p re se n ta tio n a re a ccu ra te a n d th a t th e o p in io n s e xp re s se d a re fa ir a n d re a so n a b le , n o re p re se n ta tio n o r w a rra n ty ,
e xp re ss o r im p lie d , is m a d e a s to th e fa irn e ss , a ccu ra cy, co m p le te n e ss o r co rre ctn e ss o f th e in fo rm a tio n , o p in io n s a n d co n c lu sio n s co n ta in e d in th is p re se n ta tio n . T o th e m a x im u m e xte n t p e rm itte d b y
la w , n o n e o f D im e rix , its o ffice rs , d ire cto rs , e m p lo ye e s a n d a g e n ts, n o r a n y o th e r p e rso n , a cce p ts a n y re s p o n sib ility a n d lia b ility fo r th e co n te n t o f th is p re se n ta tio n in c lu d in g , w ith o u t lim ita tio n , a n y
lia b ility a risin g fro m fa u lt o r n e g lig e n ce , fo r a n y lo ss a risin g fro m th e u se o f o r re lia n ce o n a n y o f th e in fo rm a tio n co n ta in e d in th is p re se n ta tio n o r o th e rw is e a risin g in co n n e ctio n w ith it.
T h e in fo rm a tio n p re s e n te d in th is p re s e n ta tio n is su b je ct to ch a n g e w ith o u t n o tice a n d D im e rix d o e s n o t h a ve a n y re sp o n sib ility o r o b lig a tio n to in fo rm yo u o f a n y m a tte r a risin g o r co m in g to th e ir
n o tice , a fte r th e d a te o f th is p re s e n ta tio n , w h ich m a y a ffe ct a n y m a tte r re fe rre d to in th is p re se n ta tio n .
T h e d istrib u tio n o f th is p re s e n ta tio n m a y b e re stricte d b y la w a n d yo u sh o u ld o b se rve a n y su ch re strictio n s .
F o rw a rd lo o k in g s ta te m e n ts
T h is p re se n ta tio n c o n ta in s c e rta in fo rw a rd lo o kin g sta te m e n ts th a t a re b a se d o n th e C o m p a n y ’s m a n a g e m e n t’s b e lie fs, a ssu m p tio n s a n d e xp e cta tio n s a n d o n in fo rm a tio n cu rre n tly a va ila b le to
m a n a g e m e n t. S u ch fo rw a rd lo o kin g s ta te m e n ts in vo lve kn o w n a n d u n kn o w n risks, u n ce rta in tie s, a n d o th e r fa c to rs w h ic h m a y ca u s e th e a ctu a l re su lts o r p e rfo rm a n c e o f D im e rix to b e m a te ria lly
d iffe re n t fro m th e re s u lts o r p e rfo rm a n ce e x p re sse d o r im p lie d b y su ch fo rw a rd lo o kin g sta te m e n ts . S u ch fo rw a rd lo o kin g sta te m e n ts a re b a se d o n n u m e ro u s a ssu m p tio n s re g a rd in g th e C o m p a n y ’s
p re se n t a n d fu tu re b u s in e ss s tra te g ie s a n d th e p o litica l a n d e co n o m ic e n viro n m e n t in w h ich D im e rix w ill o p e ra te in th e fu tu re , w h ic h a re su b je ct to ch a n g e w ith o u t n o tic e . P a st p e rfo rm a n c e is n o t
n e c e ssa rily a g u id e to fu tu re p e rfo rm a n c e a n d n o re p re se n ta tio n o r w a rra n ty is m a d e a s to th e like lih o o d o f a ch ie ve m e n t o r re a so n a b le n e s s o f a n y fo rw a rd lo o kin g sta te m e n ts o r o th e r fo re c a s t. T o th e
fu ll e xte n t p e rm itte d b y la w , D im e rix a n d its d ire cto rs, o ffice rs, e m p lo ye e s, a d vise rs, a g e n ts a n d in te rm e d ia rie s d is cla im a n y o b lig a tio n o r u n d e rta kin g to re le a se a n y u p d a te s o r re visio n s to
in fo rm a tio n to re fle c t a n y c h a n g e in a n y o f th e in fo rm a tio n co n ta in e d in th is p re se n ta tio n (in clu d in g , b u t n o t lim ite d to , a n y a ssu m p tio n s o r e xp e cta tio n s se t o u t in th e p re se n ta tio n ).
2
Dimerix Limited (ASX:DXB)
Dimerix has 2 Phase 2 clinical trial programs starting recruiting in Q3 CY2018
1. DMX-200 for Focal Segmental Glomerulosclerosis (FSGS)
• Phase 2a US Orphan drug designation achieved - path to US drug registration
• Reduced risk of adverse safety events due to use of known molecules
2. DMX-200 for Diabetic Kidney Disease (DKD)
• Compelling data from recently completed Phase 2a study for this more common disease
3. “Receptor HIT” drug discovery platform
• Multiple further pipeline opportunities
• Collaborative drug discovery and development opportunities
Note: FSGS and DKD are sub indications of Chronic kidney disease (CKD)
3
Corporate overview
Corporate snapshot Share price history
ASX code: DXB#
Share price (13 June 18): $0.105
Market cap: $16.3m
Cash (30 Mar 2018): $7.55m
Shares on issue* 155m
#
Consolidation (20:1) completed 31 st October 2017
*Unlisted Performance Shares: 3.75.m; Options (ESOP): 3.47m
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What is DMX-200?
• DMX-200 is an adjunct therapy. We
administer two existing, well known drugs,
to achieve a synergistic effect
• The two drugs used are:
• Propagermanium – CCR2 antagonist with
decades of use in Japan for chronic Hepatitis B
• Irbesartan – existing standard of care,
angiotensin receptor blocker. Irbesartan is a
blood pressure medication
Dimerix has a granted patent (in the USA and elsewhere) over this method of treatment.
5
Chronic kidney disease (CKD)
• CKD is a growing global health problem affecting
over 10% of the population
• Damaged kidneys “leak” proteins into the urine. This
is called proteinuria.
• Proteinuria is the most common symptom of the
disease and is the strongest prognostic indicator
of disease progression
• Kidney disease generally gets progressively worse,
with patients whose kidneys fail, requiring dialysis
or kidney transplant
6Current Treatments
• First line therapy is the use of drugs to reduce blood
pressure, which can reduce proteinuria but do not stop
progressive kidney failure
• In some types of kidney disease (eg FSGS), patients are
W ill in re m iss io n
given a cocktail of drugs including immunosuppressants and
steroids such as prednisone, which have poor side effects
and require repeated treatment cycles
• There is a huge medical need for a safe treatment which R e la p s e fro m
n e p h ro tic syn d ro m e
can significantly reduce proteinuria and prolong the life
of the kidney
7Market value of lead clinical programs – DMX-200 for FSGS and DKD
Focal segmental glomerulosclerosis (FSGS) Diabetic Kidney Disease (DKD)
• FSGS is a very serious disease and is • DKD is the single most common cause of CKD
characterized by rapid progression to end- worldwide and is associated with significant
stage renal disease increase in cardiovascular morbidity and
mortality
• DMX-200 has US Orphan Drug Designation • US prevalence is estimated as 3% of the
for FSGS population (9 million patients)
Independent analysts estimate FSGS drug sales The North American and global markets are
in the USA to be worth USD $1 billion per annum expected to reach $1.3 billion and $2.9 billion in
2020 (respectively)
Sources: Persistence Market Research, Diabetic Nephropathy Market Report, 2015; Diabetes 2025 – U.S., state and metropolitan trends, Institute for Alternative Futures; Boyle et al. Projection of the year 2050
burden of diabetes in the U.S. adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence, Population Health Metrics, 2010, 8:29; Boer et al. Temporal trends in the prevalence of
diabetic kidney disease in the U.S, JAMA. 2011; 305 (24): 2532-2539; www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm
8Market value – DMX-200
Comparable companies in the US with
developments in FSGS are capitalised at
more than $500 million
9Compelling data for DMX-200 from the Phase 2a Trial
• When introduced, the current standard of care
medication (irbesartan) was a step change in Diabetic proteinuria mean reduction 35.6% n=10
the treatment of chronic kidney disease
patients
• In 2001 irbesartan was studied in a large
group of type 2 diabetics. It was shown to
reduce proteinuria levels by 24%
• Dimerix's 2017 Phase 2a study showed a
further 35.6% reduction of proteinuria levels
Our Phase 2a results represent a quantum leap in the way proteinuria levels can be managed. We are
now moving into a further two Phase 2 studies to confirm our results in FSGS and DKD patients.
10DMX-200: FSGS and DKD studies to be conducted in parallel
• Both trials are randomised, double blind placebo-controlled, crossover studies
• “Crossover” trial design means that all patients receive both placebo and DMX-200 on the
trials, in randomised order
• These studies will investigate AT1R and CCR2 Targets for Inflammatory Nephrosis, and have
been titled ACTION.
• ACTION FOR FSGS: Phase 2a trial will study the effects of DMX-200 in around 10 patients
with FSGS - endpoints including safety and a number of efficacy (proteinuria reduction)
• ACTION FOR DKD: Phase 2b trial will study the effects of DMX-200 in around 40 patients
with DKD - primary end point change in 24hr albumin creatinine ratio (ACR) based on
identified patient responses in the Phase 2a study
11DMX-200 Timelines
Completed activities
Activity 2015 2016 2017 H1 2018 H2 2018 H1 2019 H2 2019 2020
Phase 2a CKD “all comers” study
FSGS + DKD CRO appointment,
ethics submissions, lead site
Phase 2a in FSGS
Phase 2b in DKD
Orphan Drug Designation US Europe
Regulatory Authority engagement US pre IND European authority and US IND filing
Australian Japanese
Intellectual Property patent US patent patent Ongoing examination in Europe and new applications for dose and formulation
Single pivotal FSGS Phase 3
Licensing opportunities FSGS, DKD, core patents
Completed activities Current development activities Dimerix or partner future activities 12Significant milestones
DMX-200 for FSGS and DKD
ü Ongoing – Partnering discussions for FSGS and DKD
ü CY18Q2 – Principal Investigator and CRO engaged for ACTION studies
q CY18Q2 – Ethics applications for ACTION studies
q CY18Q3 – Sites open and commencement of patient recruitment for ACTION studies
q CY18Q3 – European orphan drug application for FSGS (already granted in the US)
q CY18Q4 – European regulatory engagement for FSGS development path
q CY19Q1 – Commercial manufacturing data available for regulatory filings
q CY19Q3 – Preliminary ACTION for DKD data available
q CY19Q4 – Preliminary ACTION for FSGS data available
13DMX-200 Intellectual Property – a licencing opportunity
• Dimerix has granted patents in the USA, Australia and
Japan covering our lead program DMX-200 (US patent no.
9,314,450); and pending applications in Europe and other
major jurisdictions including
• The 9,314,450 patent covers the use of CCR2 antagonists in
conjunction with, or sequential to, administration of
angiotensin receptor blockers (ARBs), inclusive of treatment
of CKD – potentially a license opportunity to any company
developing a CCR2 antagonist to be used with an ARB
• Additional patent applications filed for formulation and dosage
regimes for DMX-200
• The therapeutic use patent expires in 2032
14Dimerix receptor-HIT platform
Receptor-HIT
• Patented tool that enables understanding of receptor interactions
• Particularly suited to G-Protein Coupled Receptors (GPCRs) – most targeted receptor class for drug discovery
• Can identify new uses for existing drugs and drive the discovery of new drugs and research programs
Global pharmaceutical companies need access to Receptor-HIT technology to develop safe new drugs
15Key takeaways – Dimerix Limited (ASX: DXB)
1. Strong track record in delivering regulatory, patent and clinical milestones
2. Two Phase 2 trials in kidney diseases about to commence, as a follow up to last
year’s Phase 2a trial, where compelling clinical data was seen
3. Significant market opportunity – across the areas of FSGS (orphan disease) and
DKD
4. Funded to progress Phase 2 trials to significant inflection points
16Contact Kathy Harrison Chief Executive Officer + 61 419 359 149 kathy.harrison@ dimerix.com Dimerix Limited ACN 001 285 230 www.dimerix.com
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