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IMMUTEP LIMITED Call Transcript 2014

Oct 22, 2014

65122_rns_2014-10-22_4a98bf4b-79fb-4950-b410-3cf43a5fb45c.pdf

Call Transcript

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Prima BioMed

Shareholder Conference Call - 24 October 2014 “Immutep: A transformational acquisition”

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.

2

Transaction Highlights

3

Philosophy behind the transaction

Transaction rationale:

  • Build a portfolio of multiple and largely independent products

  • Potential for multiple and parallel revenue streams

  • Leverage existing expertise in cancer immunotherapy market

  • Provide in-house research capabilities

  • Complete management team

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Main goal: CREATE VALUE

Result of rigorous search and due diligence process

4

Immutep: late stage biotech company in immuno-oncology

Assets to be acquired:

  • Three immunotherapeutic products in pre-clinical to Phase II development using LAG-3 immune control mechanism

  • Partnerships with leading global pharma companies ( GSK: IMP731, Costim (Novartis): IMP701, Eddingpharm : IMP321)

  • Potential revenues via milestone payments and royalties (GSK alone up to US$100m + royalties)

  • Strong patent portfolio of 11 families covering existing & potentially additional products

  • Prof. Frédéric Triebel joins as CSO along with operational staff

  • Research projects for additional new products

  • Minor revenues from production of research reagents for LAG-3

5

Consideration / Timing

  • 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

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

  • Requires shareholder approval for increase in share placement capacity at AGM (14 Nov 2014)

  • 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

  • source: Evaluate Pharma

6

Incoming Chief Scientific Officer Prof. Triebel

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  • Discovered LAG-3 gene in 1990 at Institute Gustave Roussy (IGR)

  • Director of an INSERM Unit from 1991 to 1996

  • Professor in Immunology and Biotechnology at Paris University

  • Founded Immutep in 2001

  • Managed biological follow-up of Phase I/II immunotherapy trials

  • Has successfully developed several research programs in immunogenetics

  • Published 144 peer reviewed articles and has filed 16 patent applications

7

Flexible arrangement with Bergen

  • Mitigates immediate financing risk

  • Raise up to US$37.4M through:

  • Upfront interest-free convertible security of US$2.5M

  • Payments in equity tranches over 24 months to provide working capital

  • Ability to pause/terminate at no cost

  • Provides “safety net“

  • Management focus on capital management

8

Pipeline Overview

& Product Synopsis

9

Potential to combine approaches

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

Cellular Immune
therapy, checkpoint
Antibody blockade,
therapy Antibody
… Turn on Release therapy
CVac immune the …
IMP701
system brakes
Push the
gas
Market for immunotherapeutic approaches in cancer
Cytokine therapy,
treatment will likely exceed $35bn by 2023
Antibody therapy
… …
Immunotherapy will likely form the backbone of up IMP321
to 60% of all cancer treatment in 10 years compared
with <3% today
----- End of picture text -----

– A. Baum, Citi Research, 2013

10

Combined product pipeline

Partner Preclinical Phase I Phase II a Phase II b Phase III Indication
Neopharm Group
(for Israel)
Ovarian Cancer
Neopharm Group
(for Israel)
Pancreatic Cancer
Eddingpharm
(for China)
Metastatic Breast Cancer + Chemotherapy
Eddingpharm
(for China)
Metastatic Renal Cell Carcinoma & others
GlaxoSmithKline
(WW)
Autoimmune diseases
CoStim (Novartis)
(WW)
Cancer and chronic infectious disease

11

Technology: LAG-3 background

  • LAG-3 is “Lymphocyte Activation Gene-3” and is involved in the regulation of T cells in immune responses.

  • On T cells it is an inhibitory receptor that down-modulates their proliferation and activation.

  • LAG-3 is functionally similar to CTLA-4 (targeted by Yervoy®) and PD-1 (Keytruda®)– all 3 have an inhibitory function. LAG-3 is widely expressed on T cells infiltrating human tumors and is therefore a prime target for an immune checkpoint blocker.

  • On APC (antigen presenting cells) LAG-3 is an activator. When used as a soluble protein (IMP321), there is a blocking of inhibitory signalling into T cells and it triggers APC activation through its ligand MHC class II molecules expressed on APC. This leads to T cell proliferation and activation.

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

MHCII LAG-3
APC
+ - T cell
Blocking antibody IMP321
- + -
----- End of picture text -----

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Dual technology platform

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

LAG-3 immune control
mechanism
Immunostimulatory Therapeutic
Factors Antibodies
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IMP321

Soluble form of LAG-3 used

  • in chemoimmunotherapy

IMP731 / IMP701

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

  • as a T cell adjuvant in therapeutic vaccines

  • Eddingpharm licence (China)

  • IMP731 (depleting): GSK licence

  • MP701 (antagonist): Novartis licence

13

Two key concepts

"APC Activators" and "Chemoimmunotherapy"

APC activators

  • APC activators boost the activation of the APC network in the body

  • Resulting in a more powerful antitumor immune response

Chemoimmunotherapy

  • Chemoimmunotherapy is the administration of an immunostimulant the day after chemotherapy

Activated APC network

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IMP321

• Tumour debris released following chemotherapy is captured, digested by APC and then presented to the immune system

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IMP321

  • A soluble dimeric recombinant form of LAG-3 for the activation of the APC * network in the body

  • Very stable human protein with high affinity for dendritic cells/monocytes (i.e. APC)

  • Effectively tested as chemoimmunotherapy in several indications

  • Extension to other indications possible by coupling with other first-line chemotherapy

  • Can also be used at low doses as an adjuvant to cancer vaccines

*APC = Antigen Presenting Cell

15

IMP321 clinical trials overview

Protocol Patient Population Compound Status
P001
Phase I
healthy volunteers-
influenza antigen
IMP321 (adjuvant) Completed
P002
Phase I
healthy volunteers –
hepatitis B antigen
IMP321 (adjuvant) Completed
P003
Phase I
metastatic renal cell
carcinoma
IMP321 (monotherapy) Completed
P005
Phase I
metastatic breast
carcinoma
IMP321
(chemoimmunotherapy)
Completed
P006
Phase I/IIa
disease free melanoma IMP321 (adjuvant) Completed
P007
Phase I/IIa
metastatic melanoma IMP321 (adjuvant) Completed
P008
Phase I/II
advanced pancreatic
cancer
IMP321
(chemoimmunotherapy)
Completed
P009
Phase I/IIa
melanoma IMP321 (adjuvant) Completed
P010
Phase II
prostate carcinoma IMP321 (adjuvant) Completed
  • In all trials to date IMP321 has been shown to be safe and well tolerated, with no serious adverse events.

  • Immune monitoring data has shown that T cell responses are produced.

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Clinical response rate at six months in mBC

Compared to the historical control group 254 patients with measurable disease at baseline on weekly, 3 weeks out of 4, paclitaxel (ECOG 2100 study)

Clinical benefit: Only 10% of IMP321 patients progressed in contrast to more than 50% of patients in the historical control group

A 50% response rate was observed in IMP321 patients versus 25% in the historical control group receiving chemotherapy alone

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Progressive disease Stabilisation of disease Partial response (Journal of Translational Medicine 2010)

17

CVac Update

CAN-003

  • Overall survival data – update next month

CAN-004

  • Study is in two parts

  • (A) Patients in first remission will complete dosing soon and will be or are being followed for PFS and OS

  • (B) Patients in second remission actively enrolling in Bulgaria, Belarus, Belgium, Lithuania, Latvia and Ukraine. Anticipate Poland and Germany activating soon

CAN-301

  • Bulgaria, Poland and Germany

  • Investigator meeting Oct 17-18

  • Publications/Presentations

  • CAN-002 data in JITC

  • CAN-004 poster at SITC

Manufacturing

  • Optimisation R&D continues

18

Upcoming milestones

CVac

  • OS data for CAN-003

  • Start pilot trial in resectable pancreatic cancer

  • Complete recruitment of CAN-004B

  • IMP321

  • Complete manufacturing of cGMP batches

  • Commencement of new study

  • IMP731 (GSK)

  • Start of Phase I study

  • IMP701 (Novartis)

  • Start of Phase I study

  • Other potential milestones

  • Receipt of potential milestone payments from development partners

  • Patent applications

  • Regulatory milestones

- Receipt of potential funding grants

The above milestone dates are indicative only. Exact dates are dependent on regulatory reviews & timing of clinical events

19

Financial results for 1[st] quarter FY 2015*

Net operating cash outflow for the quarter: A$3.38 million

Net operating cash outflow YTD for FY 2015: A$3.38 million

Income received in Q1: A$0.17 million Cash & term deposits at end of quarter: A$19.9 million

*according to International Financial Reporting Standards (IFRS). Results to be read in conjunction Appendix 4C published in compliance with ASX listing rules.

20

Thank you very much!

Prima BioMed

Ph: +61 2 9276 1224 Fax: +61 2 9276 1284 [email protected] www.prmabiomed.com.au

Australia Investor/Media USA Investor/Media Matthew Gregorowski Adam Holdsworth Citadel Communications ProActive Capital Ph: +61 (0) 422 534 755 Ph: +1 (646) 862 4607 [email protected] [email protected]

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