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IMMUTEP LIMITED AGM Information 2014

Nov 13, 2014

65122_rns_2014-11-13_a6e79f74-de4c-4b36-8775-e3234283fcdd.pdf

AGM Information

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CEO Presentation Annual General Meeting

Marc Voigt, CEO 14 November 2014

ASX:PRR; NASDAQ:PBMD; ISIN:US74154B2034

1

Notice: Forward Looking Statements

The purpose of the presentation is to provide an update of the business of Prima BioMed Ltd ACN 009 237 889 (ASX:PRR; NASDAQ:PBMD; Deutsche Börse:YP1B.DE). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by Prima BioMed and should not be relied upon as an independent source of information. Please refer to the Company's website and/or the Company’s filings to the ASX and SEC for further information.

The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Prima BioMed’s control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and Prima BioMed’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution. This presentation should not be relied on as a recommendation or forecast by Prima BioMed. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.

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Cancer Immunotherapy - Way of the future

“Immunotherapy – the beginning of the end for cancer”

Immunotherapies -$35bn potential/ annum. Will likely become the treatment backbone in up to 60% of cancers in the next 10 years

Andrew S Baum Citi Equities Research 22 May 2013

3

Prima in Prime Position!

  • Immunotherapy rapidly growing & evolving industry

  • Multiple approaches with multiple products – diversified portfolio

  • Leading edge research & IP generating new candidates

  • Strong commercial partnerships with potential future revenues

  • Strong research team and advisory boards

  • Positive data for CVac™

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Transformational Acquisition

4

Prima‘s Potential in Multiple Approaches

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

Immune
Cellular
checkpoint
therapy,
Turn on
agents,
Antibody Release
the Antibody
therapy
the
… therapy
immune
brakes …
CVac
system IMP701
Push the
gas
Cytokine therapy,
Antibody therapy

IMP321
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5

Pipeline

Partner Preclinical Phase I Phase IIa Phase IIb Phase III Indication
Neopharm Group
(for Israel)
CVac Ovarian Cancer
Neopharm Group
(for Israel)
CVac Pancreatic Cancer
Eddingpharm
(for China)
IMP321 Metastatic Breast
Cancer +
Chemotherapy
Eddingpharm
(for China)
IMP3 21 Metastatic Renal
Cancer & Others
GlaxoSmithKline
(WW)
IMP731 Autoimmune
disease
CoStim (Novartis)
(WW)
IMP701 Cancer and chronic
infectious disease

6

New Prima BioMed

  • Portfolio of advanced products as well as R&D

  • Strong partnerships with big pharma companies (GSK, Novartis, Eddingpharm, Neopharm)

Partly no development costs = lower risk

  • Ongoing revenue potential: milestones are nearmid- and long-term oriented

  • Global grant options in Australia, Germany and France

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Mission: Emerging leader in immuno-oncology

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Expanded Operational Management Team

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Christian Toloczyki, PhD, Director Quality Assurance

25+ years’ experience in the pharmaceutical, biotechnological and medical device industries and strong background in quality assurance processes by holding different positions with responsibility for development, testing, production and quality control

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Frank Fliegert, PhD, Global Medical Director

8+ years’ experience in various R&D positions, held position as Vice President Clinical Development at NOXXON, as Clinical Pharmacology Program Leader at Boehringer-Ingelheim and as Head of the Clinical Pharmacology Unit at SynteractHCR

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Michael Buchholz, PhD, Global Director of Manufacturing

manages the manufacturing of CVac; prior he was a project manager at the Fraunhofer IZI; before completed his PhD at the Centre for Regenerative Medicine at the University of Bath and has a degree in Biochemistry from the Free University in Berlin

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Jeanine Ronniger, Global Project Director

15+ years of experiences in the pharmaceutical research industry to lead and support actual and future programs;

her scientific knowledge based on 11 years intensive care unit as registered nurse followed by further educations on Business Administration, Consumer Health Care and Project Management

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Larisa Chisholm, Business Development and Intellectual Property Manager

manages the intellectual property portfolio, worked at the Burnet Institute; has a Bachelor of Science (Hons) majoring in Biochemistry and Genetics and a Master’s Degree in Business Administration

8

Upcoming Catalysts in CY2015

  • Start of new clinical trial with IMP321

  • Continued development of phase I study with IMP731

  • Potential material milestone payments during 2015 (GSK)

  • Start of phase I study with IMP701 (Novartis)

  • CVac: patient recruitment of CAN-004B and CAN-301,

  • Final OS readout of CAN-003

  • Achievement of regulatory milestones

  • Application for potential grants

9

FINANCIAL DATA FY2014

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Key Financial Data of FY 2014

CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

30 June2014 30 June2013 30 June2012
TOTALOTHER INCOME $ 3.140.066 $ 4.005.394 $ 4.202.567
Expenses
Research & development and intellectual
property
$ (11.930.857) $ (14.005.259) $ (15.118.816)
Corporate administrative expenses $ (4.092.623) $ (4.851.195) $ (5.977.619)
Depreciation,loss on forex $ (446.360) $ (287.738) $ (3.047.092)
Loss beforeincome taxexpense $ (13.329.774) $ (15.138.798) $ (19.940.960)
Loss after income tax expense for the
year
$ (13.343.381) $ (15.225.671) $ (19.940.960)
Other Comprehensive Income
Total comprehensive loss for the year $ (13.400.802) $ (15.261.003) $ (20.058.195)

Cash burn rate has decreased over the last three FYs! Cash position: last 4C: ~20m AUD

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IMMUTEP TRANSACTION

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Consideration

  • Total consideration up to approx. US$28M:

  • US$18M in cash (US$10.8M upfront payment; 40% based on milestones/retention)

  • US$3M in ordinary PRR shares

  • 200M options and warrants (approx. US$7M in value) partly dependent on milestones

  • Consideration in context:

Average upfront payment for licensing a single Phase II oncology product is US$38M; average deal value is US$221M*

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Attractive acquisition price

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  • source: Evaluate Pharma

CVAC OVERVIEW

14

FY2014 CVac in review

CAN-003

  • Very Positive Interim Overall Survival Data:> 36Mo CVac vs 25.53Mo OSC

  • Clear Target Patient Population identified of 2[nd] remission EOC patients

  • Observation continues

CAN-004B

  • 2nd remission EOC patients, enrolment ongoing (21 sites active) -> more sites will be activated

  • CAN-301

  • CVac in pancreatic cancer commencing Q4 2014

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Continu ous optimisation for minimising costs and reducing risks

15

Ovarian Cancer – Second Remission

Overall Survival

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Data from CVac CAN-003 protocol Overall Survival 9 Oct 2014

16

Clinical & Manufacturing Priorities

  • In general: active management of clinical development program to ensure best potential clinical benefit and optimal capital allocation

  • Review CAN-004A trial in light of CAN-003 results, Immutep acquisition and clinical development priorities of IMP321, CAN-004B and CAN-301

  • Comparability across 3 global sites now completed and centralised to Leipzig facility

  • Refinement and optimization of manufacturing is an ongoing task

  • Majority (app. 2/3) of CAN-003 CVac patients required one MNC collection only

17

OUTLOOK

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Outlook for CY 2015

  • Continued development of CVac:

  • Recruitment of CAN-004 (B): Ovarian cancer in 2[nd] remission

  • Recruitment of CAN-301: Pancreatic cancer

  • Continued refinement & optimisation of manufacturing

  • Final OS data of CAN-003

  • Start of new trial with IMP321

  • Continued development of phase I study with IMP731 (GSK)

  • Start of phase I study with IMP701 (Novartis)

  • Ongoing research

  • Active Business Development

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Prima Value Drivers

  • Diversified portfolio in one of the most interesting fields of immuno-oncology

  • Good Intellectual Property position & regulatory advantages (e.g. Fast Track in US)

  • Excellent partnerships with the pharmaceutical industry and other research partners

  • Potential revenues from milestones

  • Compelling clinical data from CVac and IMP321

  • Good team of highly qualified experts

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THANK YOU!

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Professor Frédéric Triebel Presentation to the Annual General Meeting of Shareholders

14 November 2014

ASX:PRR; NASDAQ:PBMD; ISIN:US74154B2034

1

Cancer Immunotherapy (Immuno-Oncology : “IO”)

A quick lesson!

2

Why do we get cancer?

  • Our immune system is trained to tell the difference between self and non-self

  • Cancers have clever escape mechanisms that allow them to hide

  • If the immune system can’t see a cancer cell, it can’t kill it

  • If the cancer cell turns off immune cells, they can’t be killed

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Immunotherapy uses the immune system to kill cancer

3

What are T cells and APC?

  • APC are antigen presenting cells – they show antigens to T cells

  • Dendritic cells are an important type of APC

  • In cancer, APC show antigen to T cells to activate them

  • T cells have a number of functions

  • In cancer the role of T cells is to

  • Stimulate production of anti-cancer antibodies

  • Directly kill cancer cells

  • Activate other cancer fighting cells

4

Dendritic Cells & IMP321

  • Dendritic cells (DC) and

  • monocytes/macrophages form a network in tissues

  • DC cover 25% of human skin surface area thanks to their long dendrites

  • This dendritic network is a 1st line of defense (immune surveillance) against pathogens or tumor cells

Dendrites

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  • Activating this network with IMP321 leads to:

  • Activation/Expansion (firing up) of APC which directly kill tumour cells

  • Activated APC present more tumour antigen to CD8 T cells (Killer T Cells) which expand, then kill tumour cells and provide long-term anti-tumour memory

5

What is LAG-3?

  • Lymphocyte Activation Gene 3 = LAG-3

  • Can both inhibit and activate immune

responses

  • LAG-3 on the surface of T cells can inhibit their function by signalling or putting on the brakes

  • LAG-3 binding to molecules on APC’s called MHC can activate them to present antigen to T cells

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LAG-3 regulates T cells

6

Immutep’s LAG-3 products

IMP321, IMP731 and IMP701

7

Immutep‘s Dual Technology Platform

LAG-3 immune control mechanism Activator

Inhibitor

IMP321

IMP731 / IMP701

Soluble form of LAG-3 used

  • in chemo-immunotherapy

  • as a T cell adjuvant in

  • therapeutic vaccines

LAG-3 on T cells as a target for therapeutic antibodies

  • IMP731 : GSK licence

  • IMP701 : Novartis licence

  • Eddingpharm licence (China)

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Two signalling mechanisms = more Tx product options

8

Immutep’s First-In Class Activator

IMP321

9

IMP321 – How does it work?

  • DC/monocytes activated: stimulates expansion of activated T cells

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CD8 T cell expansion
Activated DC/monocytes
Immature DC
LAG-3Ig Primary target cells
MHC II (IMP321)
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Secondary target cells
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IMP321 (LAG-3Ig)

  • highly efficacious in multiple animal models of cancer and infectious

  • disease

  • Well tolerated safety

  • signal of efficacy in Phase 2A

  • no anti-IMP321 antibody formation

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10

Future plans

  • Completion of IMP321 manufacturing in 2015

  • Planning of new IMP321 clinical trial will commence after AGM

  • Potential new trials in metastatic breast cancer and/or in combination with other options

  • R&D on preclinical candidates to continue

  • GSK and Novartis could enter phase I

11

THANK YOU!

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