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.

ALGORAE PHARMACEUTICALS LIMITED AGM Information 2015

Nov 11, 2015

64249_rns_2015-11-11_db9eed79-14f9-45d5-91c8-392dedaad2ae.pdf

AGM Information

Open in viewer

Opens in your device viewer

==> picture [241 x 140] intentionally omitted <==

CEO Presentation to AGM Dr Ken Taylor

12 November 2015 http://www.lctglobal.com

Safe Harbour statement

==> picture [113 x 52] intentionally omitted <==

This document contains certain forward-looking statements, relating to LCT’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates.

Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements.

  • There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other health authorities’ requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales.

In particular, management’s expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects.

  • Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

LCT is providing this information as of the date of this presentation and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.

ASX:LCT | OTCQX: LVCLY | www.lctglobal.com | LCTglobal

One patient’s experience of the impact of treatment with NTCELL

==> picture [113 x 52] intentionally omitted <==

A patient in the Phase I/IIa clinical study describes her experience of Parkinson’s disease and treatment with NTCELL

https://www.dropbox.com/s/n2te7xhg72w9ggd/Living%20Cell%20T = echnologies%20Nov%202015%201080P.mp4?dl 0

2015 milestones

==> picture [113 x 52] intentionally omitted <==

  • Continued development of NTCELL[®] for Parkinson’s disease

  • Completed Phase I/IIa clinical trial of NTCELL

  • Presented trial result at International Congress of Parkinson’s Disease and Movement Disorders, San Diego

  • Announced 42 week post NTCELL treatment efficacy

  • Met with Scientific Advisors to design next clinical study

  • Obtained NZ regulatory input to Phase IIb clinical study to qualify for provisional (fast track) consent to market

  • Secured supply of NTCELL, manufacturing GMP licences

  • • Filed new patent in USA

  • Applied for non dilutive financing

  • Awarded Callaghan Innovation grant

  • Presented LCT progress to brokers in Australia and New Zealand

Develo in NTCELL for Parkinson’s p g

==> picture [113 x 52] intentionally omitted <==

NTCELL development target First-in-class disease modifying treatment

Incidence

  • 7–10 million people living with Parkinson’s worldwide

==> picture [132 x 133] intentionally omitted <==

  • 8,000 people living with Parkinson’s in New Zealand

  • 800 new Parkinson’s patients diagnosed each year in New Zealand

Treatment

  • No disease modifying treatment or cure

  • • Symptomatic treatments available but limited duration of efficacy

  • Levodopa (standard symptomatic treatment) now 50 years old

  • All data approximate and estimated

NTCELL treatment is implantation of encapsulated choroid plexus cells into the brain

Front view Side view

==> picture [488 x 268] intentionally omitted <==

Choroid Plexus:

  • Secretes cerebrospinal fluid (CSF)

  • Provides neurotrophic factors

  • Provides neuroprotective factors

  • Removes toxin (drugs, metals, etc.)

  • • Clears waste products

Developing NTCELL for Parkinson’s

==> picture [113 x 52] intentionally omitted <==

NTCELL is encapsulated porcine choroid plexus cells “Factory” approach for nerve growth: not a single drug intervention Plasticity: NTCELL adapts to disease in vivo Supply: Porcine advantage over human Brain: immuno-privileged

Advantage over stem cells No concern of tumorigenicity Defined cell population rather than unknown mixed cell types No current stem cell technology to generate choroid plexus cells Targeting Parkinson’s Severe unmet medical need Cost to benefit: focus on benefit First disease modifying treatment Acceptance of DBS procedure, identified site and endpoint

Completed Phase I/IIa clinical trial of NTCELL

==> picture [113 x 52] intentionally omitted <==

NTCELL implantation was safe in four patients

  • Administered via unilateral implantation into the putamen of four patients with Parkinson’s

  • Treatment safe and well tolerated (primary endpoint).

  • No adverse events related to NTCELL

  • Some were related to the procedure itself

  • No clinical or laboratory evidence of PERV transmission in patients or partners.

NTCELL implantation improved clinical features of Parkinson’s

  • Sustained improvement on clinical features in the UPDRS, UDysRS and PDQ-39

Encouraging results justify a confirmatory study

  • Study small in scale but results warrant further studies of NTCELL for Parkinson’s

  • Second clinical trial to confirm potential as a disease modifying treatment

Presented trial result at International Congress of Movement Disorders, San Diego

==> picture [113 x 52] intentionally omitted <==

==> picture [648 x 319] intentionally omitted <==

Announced 42 week post NTCELL implant efficacy

==> picture [113 x 52] intentionally omitted <==

Progression of Parkinson’s disease halted In all four patients NTCELL treatment has stopped the progression of Parkinson’s disease as measured by globally accepted and validated neurological rating scales

Improvement in neurological score In all four patients the 42 week post-implant data show there is a clinically and statistically significant improvement in the patients’ neurological score from their pre-implant baseline

Equivalent of 5 years remission from PD That improvement is equivalent to approximately 5 years of Parkinson’s disease remission and is maintained 74 weeks after NTCELL transplant in the first patient

UPDRS (Unified Parkinson’s Disease Rating Scale) 20 pt decrease clinically & statistically significant

==> picture [113 x 52] intentionally omitted <==

==> picture [623 x 339] intentionally omitted <==

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

UPDRS Total 'Off'
10
5
0
-5
Pat 1
-10
Pat 2
-15
Pat 3
-20
Pat 4
-25
Average
-30
-35
0 10 20 30 40 50 60 70
Weeks Post Implant
UPDRS Change from baseline
----- End of picture text -----

UPDRS Motor Function Improvement clinically & statistically significant

==> picture [113 x 52] intentionally omitted <==

==> picture [623 x 339] intentionally omitted <==

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

UPDRS PART III OFF (Motor Function)
10
5
0
Patient 001
-5 Patient 002
Patient 003
-10
Patient 004
Average
-15
-20
0 6 12 18 24 30 36 42 48 54 60 66 72
Weeks Post Implant
Motor Function Change from baseline
----- End of picture text -----

PDQ-39 – Quality of Life Significant improvement

==> picture [113 x 52] intentionally omitted <==

==> picture [623 x 339] intentionally omitted <==

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

PDQ-39
10
5
0
Patient 001
-5 Patient 002
Patient 003
-10
Patient 004
-15 Average
-20
0 6 12 18 24 30 36 42 48 54 60 66 72
Weeks Post Implant
PDQ-39 Change from baseline
----- End of picture text -----

UDysRS – Dyskinesia Rating Scale Significant improvement

==> picture [113 x 52] intentionally omitted <==

UDysRS 'On'

==> picture [586 x 274] intentionally omitted <==

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

20
15
10
5
0
Patient 001
-5
Patient 002
-10
Patient 003
-15
-20 Patient 004
-25
Average
-30
-35
0 6 12 18 24 30 36 42 48 54 60 66 72
Weeks Post Implant
Score Change from baseline
----- End of picture text -----

Scientific advisors helping design next study

==> picture [113 x 52] intentionally omitted <==

Auckland Clinical Site Scientific Advisors Barry Snow, MBChB, FRACP Anne B Young, MD Principal Investigator, Neurologist Professor of Neurology, Harvard Medical School, Boston, USA Ari Bok, MBChB, FRACS Roger Barker, MD Patrick Schweder, MBChB, FRACS Professor of Clinical Neurosciences Neurosurgeons and Deputy Director, John van Geest Centre for Brain Research, University Mark Simpson, MBChB, FRACP of Cambridge, UK Investigator, Neurologist Richard Faull, MBChB, PhD Lorraine Macdonald, RGON, BHSc Professor of Anatomy and Director, (Nsg) Study Nurse Centre for Brain Research, University of Auckland, NZ DSMB Prof Tim Anderson (Neurologist, Chair); Dr Rod Ellis-Pegler (ID); Dr Andrew Hughes (Neurologist)

NZ regulatory input to Phase IIb clinical study

==> picture [113 x 52] intentionally omitted <==

To qualify for provisional (fast track) consent to market:

  • Define efficacy and any placebo contribution

  • Define optimal dose of NTCELL implantation

  • Define initial target Parkinson’s disease patient subgroup

Phase IIb study

==> picture [113 x 52] intentionally omitted <==

Group 1: Patients 1-6

  • 4 dosed and 2 placebo, randomly assigned

  • 40 NTCELL microcapsules ( 5%) bilaterally [total of 80 microcapsules], or placebo [sham surgery]

Group 2: Patients 7-12

  • 4 dosed and 2 placebo, randomly assigned 80 NTCELL microcapsules ( 5%) bilaterally [total of 160 microcapsules], or placebo [sham surgery]

Group 3: Patients 13-18

  • 4 dosed and 2 placebo, randomly assigned 120 NTCELL microcapsules ( 5%) bilaterally [total of 240 microcapsules], or placebo [sham surgery]

  • The study will be unblinded upon completion of the 26-week follow-up period

  • • The placebo patients will receive the optimal dose of NTCELL

Secured supply of NTCELL, manufacturing GMP licences

==> picture [113 x 52] intentionally omitted <==

  • Pigs – Bred at Kumeu facility

  • Manufacturing – GMP facility at Papatoetoe

  • People

  • Employed key personnel

  • LCT headcount increases from 9 to 21

Filed new patent in USA

==> picture [113 x 52] intentionally omitted <==

  • United States Patent and Trademark Office

  • Application Number 62/162,390

  • Treatment of CNS disease with encapsulated inducible choroid plexus cells

  • Date 15/05/2015

Financing

==> picture [113 x 52] intentionally omitted <==

  • See financial annual report 2015

  • Awarded Callaghan Innovation grant – 20% rebate on Research and Development expenditure

  • Assessing partnership opportunities

  • Have stock broker feedback on fundraising opportunities

Next steps strategy

==> picture [113 x 52] intentionally omitted <==

  • Goal is to launch NTCELL as the first disease modifying treatment for Parkinson’s disease in 2017

  • New Zealand first launch country

  • Most efficient approach to increasing the number of NTCELL treated patients

  • This will expand the NTCELL quality, safety, and efficacy data • Necessary to fully globalise the product

  • Will allow submissions to FDA, EMA and Asian authorities

  • May seek a global commercialisation partner to fully realise the market potential of NTCELL

Creating shareholder value

==> picture [113 x 52] intentionally omitted <==

  • Focused strategy – NTCELL for Parkinson’s disease

  • Continue to meet milestones

  • Minister of Health approved Phase IIb study of NTCELL today

  • • Capital raising options are under consideration by the Board

  • • OPF, under licence from DOL, continues to pursue its diabetes strategy in the USA

  • LCT continues to hold a 50% share in DOL

  • 2015 – positive ASX announcements negated by substantial shareholders, who invested in LCT when it was a pure diabetes play, liquidating their shareholdings totalling 42 million shares

  • Vasson, Palmert, Coalco, and Persistency have zero balance

  • • Positive ASX announcements should now reflect share price movement

==> picture [357 x 540] intentionally omitted <==

==> picture [228 x 132] intentionally omitted <==

Dr Ken Taylor, CEO [email protected] +64 276 2690

www.lctglobal.com