Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

ADALTA LIMITED Investor Presentation 2016

Sep 7, 2016

64247_rns_2016-09-07_15791052-7b85-4b03-b911-bc3b49382d70.pdf

Investor Presentation

Open in viewer

Opens in your device viewer

==> picture [131 x 101] intentionally omitted <==

==> picture [335 x 108] intentionally omitted <==

i-bodies – a new class of protein therapeutics to treat human disease

Biotech meets Broker: September 2016 Sam Cobb, CEO and Managing Director AdAlta Limited (ASX:1AD) [email protected]

Disclaimer

Investment in AdAlta is subject to investment risk, including possible loss of income and capital invested. AdAlta does not guarantee any particular rate of return or performance, nor do they guarantee the repayment of capital.

This presentation is not an offer or invitation for subscription or purchase of or a recommendation of securities. It does not take into account the investment objectives, financial situation and particular needs of the investor. Before making any investment in AdAlta, the investor or prospective investor should consider whether such an investment is appropriate to their particular investment needs, objectives and financial circumstances and consult an investment advisor if necessary.

This presentation may contain forward-looking statements regarding the potential of the Company’s projects and interests and the development and therapeutic potential of the company’s research and development. Any statement describing a goal, expectation, intention or belief of the company is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercialising drugs that are safe and effective for use as human therapeutics and the financing of such activities. There is no guarantee that the Company’s research and development projects and interests (where applicable) will receive regulatory approvals or prove to be commercially successful in the future. Actual results of further research could differ from those projected or detailed in this presentation. As a result, you are cautioned not to rely on forward-looking statements. Consideration should be given to these and other risks concerning research and development programs referred to in this presentation.

==> picture [720 x 35] intentionally omitted <==

----- Start of picture text -----

2
----- End of picture text -----

Corporate and investment summary

==> picture [8 x 9] intentionally omitted <==

==> picture [8 x 9] intentionally omitted <==

A drug discovery and development company focused on using its proprietary technology platform to generate a new class of protein therapeutics, known as i-bodies, for treating a wide range of human diseases

Investment highlights

Initial focus on treating fibrosis – high unmet medical need

==> picture [7 x 8] intentionally omitted <==

Capital structure
ASX code 1AD
Shares on issue* 100m
Shareprice(6 Sept) 22 cents
Market capitalisation $22m
Current cash $10m
Total 100%
  • 50.3m shares escrowed for 6-24 months

==> picture [7 x 8] intentionally omitted <==

==> picture [7 x 8] intentionally omitted <==

==> picture [7 x 8] intentionally omitted <==

==> picture [7 x 8] intentionally omitted <==

Advanced lead fibrosis drug candidate AD-114 with significant pre-clinical validation

Fully funded for phase 1 development of lead fibrosis drug and i-body pipeline Early commercialisation potential Experienced team with strong track record of drug development and ability to deliver

Major Shareholders %
Yuuwa Capital LP 54.06
Platinum Asset Management 8.00
Citycastle PtyLtd 5.31
La Trobe University 3.04
Robin Beaumont 1.84
Other shareholders 27.75
Total 100%

==> picture [720 x 35] intentionally omitted <==

----- Start of picture text -----

3
----- End of picture text -----

i-body technology

AdAlta is developing a new technology platform that produces unique proteins known as i-bodies, that mimic the shape of shark antibody binding domain and engineers their key stability features into a human protein, for therapeutic intervention in disease.

Long loop that enables access to novel drug targets

The single domain antigen binding region of shark antibodies is extremely stable and has a long binding loop not present in either human or next generation antibodies.

==> picture [6 x 7] intentionally omitted <==

==> picture [6 x 7] intentionally omitted <==

==> picture [6 x 7] intentionally omitted <==

==> picture [6 x 7] intentionally omitted <==

Advantages of i-bodies

High target specificity and high affinity for their target

Small proteins; 10% the size of a typical human antibody

Highly stable to proteases, high temperatures and low pH

  • Long loop that can bind to a diverse range of therapeutically relevant targets including those that are difficult for current antibody therapies

Human Antibody

i-body human protein scaffold

Shark Antibody

==> picture [6 x 7] intentionally omitted <==

Human protein – reduced risk of immune response

==> picture [720 x 35] intentionally omitted <==

----- Start of picture text -----

4
----- End of picture text -----

Fibrosis: unmet medical need with multiple indications

==> picture [8 x 8] intentionally omitted <==

Developing i-bodies as improved therapies for the treatment of fibrosis

  • a condition that is prevalent in 45-50% of all diseases

==> picture [92 x 92] intentionally omitted <==

==> picture [92 x 92] intentionally omitted <==

==> picture [91 x 92] intentionally omitted <==

==> picture [8 x 8] intentionally omitted <==

==> picture [8 x 8] intentionally omitted <==

Fibrosis can occur in many tissues of the body as a result of inflammation or damage

  • it can result in scarring of vital organs causing irreparable damage and eventual organ failure

AdAlta’s initial focus is on lung fibrosis

Collectively fibrosis represents a large unmet clinical need

==> picture [303 x 184] intentionally omitted <==

----- Start of picture text -----

Lung Eye Liver
IPF Wet-AMD & PVR NASH & CIRRHOSIS
Kidney Skin Heart
RENAL FIBROSIS SCLERODERMA CARDIAC FIBROSIS
----- End of picture text -----

5

AD-114 lead program in Idiopathic Pulmonary Fibrosis (IPF)

==> picture [9 x 10] intentionally omitted <==

AD-114 is lead i-body candidate in pre-clinical development

  • Demonstrates both anti-fibrotic and anti-inflammatory activity in the lung

  • Important for arresting and modifying the disease and tackling the treatment of idiopathic pulmonary fibrosis (IPF); this is the primary indication

==> picture [101 x 101] intentionally omitted <==

Lung

Idiopathic Pulmonary Fibrosis A chronic, highly lethal and rare disease. 50-70% mortality rate >135,000 people in US alone World wide sales ~$4.2B by 2020

==> picture [21 x 9] intentionally omitted <==

----- Start of picture text -----

IPF
----- End of picture text -----

Source: Evaluate Pharma, Orphan Drug Report 2015

==> picture [720 x 35] intentionally omitted <==

----- Start of picture text -----

6
----- End of picture text -----

AD-114 prevents lung fibrosis in disease models

Extensive pre-clinical AD-114 studies have demonstrated positive in vitro (in the lab) and in vivo (in animals) data

==> picture [172 x 139] intentionally omitted <==

==> picture [170 x 138] intentionally omitted <==

==> picture [170 x 137] intentionally omitted <==

Normal IPF lung tissue lung tissue (lung disease mouse model)

IPF lung tissue + AD-114 dosed for 21 days (lung disease mouse model)

AD-114 reduces collagen content and inflammatory cell infiltration and demonstrates a similar architecture to that of the normal lung in the Bleomycin mouse model

==> picture [720 x 35] intentionally omitted <==

----- Start of picture text -----

7
----- End of picture text -----

AD-114 key advantages compared to existing IPF treatments

  • AD-114 has greater in vitro efficacy compared to the only approved therapies Nintedanib and Pirfenidone for IPF treatment

==> picture [6 x 8] intentionally omitted <==

No effect Effect on Human tissue treatment on normal diseased / In vitro activity tissue IPF tissue – Existing IPF treatments have limited efficacy; either no effect or slow down disease progression i.e. no i-body AD-114 ✔ ✔ cure Nintedanib (Boehringer) ✗ ✔ Novel mechanism of action compared to other drugs targeting CXCR4 Pirfenidone (Roche) ✔ ✗ Very specific for diseased tissue and no effects on Other CXCR4 drug ✔ ✗ normal tissue (Sanofi)

  • AD-114 has both anti-fibrotic and anti-inflammatory effects

==> picture [6 x 8] intentionally omitted <==

Novel mechanism of action for fibrosis treatment enabling a “first in class” therapy

==> picture [720 x 35] intentionally omitted <==

----- Start of picture text -----

8
----- End of picture text -----

Global market interest in fibrosis treatments Recent transactions confirm that big pharma are actively acquiring fibrosis assets at an early stage – typically based on Phase I results

Date Company Target Acquired by Deal value (US$) Deal commentary
Sep-15 Adheron
Therapeutics
SDP051 Roche $105M upfront, plus
$475M in milestones
SDP-51 at end of Phase I for IPF
Aug-15 Promedior PRM-151 BMS $150m upfront + $1.25B Phase II IPF and myelofibrosis
Nov-14 Galecto
Biotech AB
TD139 BMS $444M Option to acquire at end of clinical
POC (no later than 60 days
following Ph 1b for IPF completion)
Aug-14 Intermune Esbriet /
Pirfenidone
Roche $8.3B Approval in Europe / Japan, phase
III in the US
Jun-13 MicroDose
Therapeutx
MMI0100 Teva
Pharmaceuticals
$40M upfront
$125M milestones
MMI0100 was in pre-clinical
development
Mar-12 Stromedix STX100 Biogen Idec $75M upfront
$487.5M milestones
End of phase I for IPF
Jul-11 Amira / BMS BMS-986020 BMS $325M upfront
$150M milestones
End of phase I for IPF

Source: Medtrack Pharma Intelligence, Informa (all IPF deals since 2011)

==> picture [720 x 35] intentionally omitted <==

----- Start of picture text -----

9
----- End of picture text -----

AD-114 development: key milestones

==> picture [653 x 288] intentionally omitted <==

----- Start of picture text -----

CY2016 CY2017 CY2018
Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
Partnering of lead
Manufacturing of lead candidate
candidate
based on other
Toxicology studies benchmark deals
Orphan designation
Phase I
Publication of data
Other fibrosis indications
BD and partnerships
----- End of picture text -----

10

Expected newsflow next 18 months

Q3 2016 Q3 2016 Orphan Drug Designation (US FDA)
Commence manufacturing of material for toxicology testing
Presentation at Discovery on Target, Boston
Orphan Drug Designation (US FDA)
Commence manufacturing of material for toxicology testing
Presentation at Discovery on Target, Boston
Q3 2016 Orphan Drug Designation (US FDA)
Commence manufacturing of material for toxicology testing
Presentation at Discovery on Target, Boston
Q4 2016 Additional AD-114 IPF fibrosis data
Hypertrophic scarring animal results for AD-114
Completion of evaluation of AD-114 with IPF clinicians Alfred Hospital
H1 2017 Presentation at Biotech Showcase, San Francisco
Data available from AD-114 NASH animal studies
Manufactured material for toxicology testing available
H2 2017 H2 2017 Eye fibrosis additional data, funded by NHMRC development grant
Completion of other pre-clinical study animal models of AD-114
Initial Kidney/Heart data available for AD-114
AD-114 toxicology results

==> picture [720 x 35] intentionally omitted <==

----- Start of picture text -----

11
----- End of picture text -----

AdAlta business model – strategy to create value

==> picture [648 x 264] intentionally omitted <==

----- Start of picture text -----

Pharma &
biotech
partnerships
Revenues: Upfronts,
i-body FTEs, milestones & i-bodies new
royalties
technology drug class
platform and Potential in multiple
In-house disease indications
library Licence to
pipeline of
pharma
drug
Revenues: major
candidates upfronts + milestones
& royalties
Invest up to key
value inflection point
----- End of picture text -----

12

Market benchmarks

April-16 with Abbvie
$40m upfront + $645m
milestones & royalties
Dec -15 with Roche
$6.4m upfront + $410m
milestones & royalties
Nov-15 with Novo-Nordisk
€9m upfront + €182m
milestones & royalties)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa asset
April-16 with Abbvie
$40m upfront + $645m
milestones & royalties
Dec -15 with Roche
$6.4m upfront + $410m
milestones & royalties
Nov-15 with Novo-Nordisk
€9m upfront + €182m
milestones & royalties)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa asset
April-16 with Abbvie
$40m upfront + $645m
milestones & royalties
Dec -15 with Roche
$6.4m upfront + $410m
milestones & royalties
Nov-15 with Novo-Nordisk
€9m upfront + €182m
milestones & royalties)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa asset
April-16 with Abbvie
$40m upfront + $645m
milestones & royalties
Dec -15 with Roche
$6.4m upfront + $410m
milestones & royalties
Nov-15 with Novo-Nordisk
€9m upfront + €182m
milestones & royalties)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa asset
April-16 with Abbvie
$40m upfront + $645m
milestones & royalties
Dec -15 with Roche
$6.4m upfront + $410m
milestones & royalties
Nov-15 with Novo-Nordisk
€9m upfront + €182m
milestones & royalties)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa asset
April-16 with Abbvie
$40m upfront + $645m
milestones & royalties
Dec -15 with Roche
$6.4m upfront + $410m
milestones & royalties
Nov-15 with Novo-Nordisk
€9m upfront + €182m
milestones & royalties)
Fibrosis
lead AD-114
Next gen
antibodies
Sep-15 acquired by Roche
$105m + $475m milestones
phase I asset
Nov-14 acquired by BMS
$444m
phase I asset
Aug-15 acquired by BMS
$150m + $1.25b milestones
phase IIa asset
Nov-14 acquired by BMS
$444m
phase I asset
Acquired by Celgene July-15
$8b Ph III, Ph II and GPCR
platform
April-16 with Boehringer
€8m payment for Ph1 GPCR
nanobody (€125m milestones
& royalties)
GPCRs Acquired Feb-15 by So
$400m Phase Ib asset + 7
clinical leads

13

Management and Board in place to deliver strategy

Sam Cobb: Founding CEO and Director

Dr John Chiplin: Independent Director

Managing Director of acquired antibody company Arana Therapeutics

Extensive experience in raising equity and commercialisation of technology

Liddy McCall & Dr James Williams : Yuuwa Capital Directors

Dr Mick Foley: Founding CSO

Expert in phage display for screening of the i-body library

Founders and investment Directors of Yuuwa Capital

Founders of iCeutica Inc (acquired 2011) and Dimerix Limited

Dr Paul MacLeman: Chairman

Managing Director of a ASX listed IDT Australia Ltd

Directors of several Australian biotech and Agritech companies Multiple FDA, CE Mark and TGA approvals

Founded biologics companies, experienced ASX listed executive

Internationally recognised SAB with proven track record of drug development

David McGibney: pre-clinical and clinical advisor

20 years with Pfizer, including Head of European R&D, developed 10+ blockbuster drugs

Brian Richardson: drug discovery and development expert

Ex-Sandoz and Novartis (40+ years), including Head of Pre-clinical Research

John Westwick: pulmonary drug discovery and development

Over 14 years experience at Novartis, head of respiratory drug discovery, with five product launches and 13 products currently in the clinic

14

AdAlta investment summary

==> picture [7 x 8] intentionally omitted <==

Powerful proprietary technology platform to develop a pipeline of i-bodies for the treatment of a wide range of human diseases

==> picture [8 x 9] intentionally omitted <==

Initial focus on treating Idiopathic Pulmonary Fibrosis and other fibrotic diseases - high unmet clinical need

==> picture [8 x 9] intentionally omitted <==

Advanced lead candidate with significant pre-clinical validation of AD-114 demonstrating anti-fibrotic and anti-inflammatory effects

==> picture [8 x 9] intentionally omitted <==

Early commercialisation opportunity

==> picture [8 x 9] intentionally omitted <==

Experienced management and Board to drive AD-114 development and secure technology platform partnerships and product licensing deals

==> picture [8 x 9] intentionally omitted <==

IPO August 2016 raised $10M to meet major milestones: clinical trials of AD-114 in fibrosis and development of i-body pipeline

==> picture [720 x 35] intentionally omitted <==

----- Start of picture text -----

15
----- End of picture text -----