IMMUTEP LIMITED — AGM Information 2016

Nov 24, 2016

Prima BioMed

Annual General Meeting CEO Presentation November 25, 2016

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ASX:PRR; NASDAQ:PBMD

Marc Voigt

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Notice: Forward Looking Statements
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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). 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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2016 Highlights
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Corporate

Clinical

Collaborations

• Sound financial management

• Sydys partnering of CVac™

• Significant analyst coverage

• JP Morgan, ASCO, ESMO,SITC conferences

• 3 Patents granted

• First Chinese manufactured biologic dosed in Europe

• TACTI-mel initiated and first patients dosed – encouraging safety data

• AIPAC initiated -first safety, PK and IM data and dose escalation

• Ongoing clinical development of our partners GSK and Novartis

• MTA with Yamaguchi /NEC for IMP321

• INSIGHT Trial Announced

• WuXi MoU

• AIPAC first and second cohort recruitment complete

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Key Financials
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Ticker	ASX: PRR; NASDAQ: PBMD
Market Cap	AUD $78.72M (23 Nov 16)
Shares on Issue Options on Issue	2,071,537,809 (23 Nov 16) 77,378,693
Net Operating cash outflow FY 16	AUD $11.3M
G&A Expenses FY 16	AUD $6.98M
R&D and Intellectual Property Expenses FY16	AUD $7.06M
Cash in bank	AUD $18.2M (3Q,2016)

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PROGRAM UPDATE

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LAG-3 Technologies

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IMP321
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Preclinical Phase I Phase IIa Phase IIb Metastatic Breast WW Prima (ex China: Eddingpharm) Cancer Phase IIb trial began Oct 2015 MOA: APC activator following first-line chemotherapy Proof of Concept WW Prima (ex China: Eddingpharm) Study in Metastatic Phase I trial began Jan 2016 Melanoma MOA: APC activator + PD-1 checkpoint inhibitor IMP731 Autoimmune WW GSK Diseases Phase I trial began Jan 2015 MOA: LAG-3 depleting antibody IMP701 WW Novartis Cancer Phase I trial began Aug 2015 MOA: Blocking LAG-3 antibody Autologous Dendritic Cell Therapy CVac ™ WW Sydys Corporation Ovarian Cancer (ex Israel: Neopharm) Phase IIb completed; New trials to be initiated

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IMP321 – one product, many
applications
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Chemoimmunotherapy - AIPAC I-O Combination Therapy – TACTI-mel Direct Injection - INSIGHT Cancer Vaccine Therapy – Yamaguchi/NEC

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Chemoimmunotherapy – adding an antigen presenting cell (APC) activator after chemotherapy treatment to boost immune responses.

• Encouraging scientific advice from EMA July 2015

 Initiated Dec 2015

• First patient dosed Feb 2016

• First safety, PK and immune monitoring data June 2016 – dose escalation

• Second safety cohort recruitment completed

• First safety run in phase and IM data expected Dec 2016

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AIPAC trial: Active Immunotherapy PAClitaxel

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Phase IIb chemo-immunotherapy in metastatic breast cancer in different EU countries
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First patient in Feb. 2016 Safety-run in, 15 (6+9) patients, 2 cohorts	Arm 1_,98 patients:_ paclitaxel + IMP321		Multicentre, randomised, double-blind Safety and Efficacy Data
	Arm 2_,98 patients:_ paclitaxel + placebo

Overview	Overview
Design	Phase IIb, randomised, placebo controlled, double blinded, multinational
Primary Objective	Run-In: Recommended phase II dose Randomised: paclitaxel + IMP321 vs. paclitaxel + placebo
Other Objectives	Safety, efficacy
Patient Population	Patients with advanced metastatic breast cancer indicated to receive first line chemotherapy with weekly paclitaxel
Treatment	Safety run-in: IMP321 + Paclitaxel Arm 1: Paclitaxel + Placebo Arm 2: Paclitaxel + IMP321
Current Countries	NL, BL, HUN (11 sites active as of Oct 16) , stage II will be conducted in more countries and sites

Status report

• Initial safety data of the first cohort of patients confirmed the safety and tolerability of IMP321 with no dose limiting toxicities, June 2016 • Recruiting in the safetyrun in is completed • Start of randomised phase expected early 2017

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TACTI-mel Two Active
Immunotherapies in melanoma
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Combination therapy – combining an APC activator and a checkpoint inhibitor to kick start the immune response after removing the brake.

Initiated Jan 2016

Being conducted at 6 sites in Australia

First patient dosed May 2016

First safety and immune monitoring data Dec 2016 – then dose escalation

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TACTI-mel trial: Two ACTive Immunotherapeutics in melanoma

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Phase I study in immuno-immuno combination in unresectable or metastatic melanoma in Australia
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		up to 24 patients, 3 cohorts, max. 8 patients each	IMP321 + anti-PD-1 (Keytruda)	Multicenter, open label, dose escalation		Safety and tolerability
		First patient in May 2016
		Overview		Status report
		Design	Phase I, multi-centre, open-label, dose	•6 clinical sites are
			escalation	approved and all are
		Primary Objective	Safety, tolerability and recommended dose finding for phase II with pembrolizumab +	activated
			IMP321 in unresectable or metastic melanoma	•Dose escalation decision
		Other Objectives	Pharmakokinetic and pharmakodynamic of	of the interim data of the
			IMP321, objective response rate, time to next treatment, progress-free survival	first cohort will be
		Patient Population	Patients with asymptomatic or suboptimal response after three cycles of pembrolizumab	expected at the end of this/beginning of next
		Treatment	Up to 24 patients	year
			3 cohorts: 1/6/30 mg IMP321; s.c. q2w +
			pembrolizumab; starting with the 5th cycle of
			pembrolizumab

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Partner IMP321 trials…
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• Yamaguchi/NEC have commenced clinical research using IMP321 as an adjuvant together with their own peptides and adjuvant in solid tumours.

• INSIGHT trial – German investigator sponsored trial in solid tumours testing direct intratumoral injection – currently waiting CA and EC approvals

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IMP731 Update
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• GSK2831781, GSK’s investigational product derived from IMP731 antibody, in ongoing clinical trial in the context of autoimmune diseases

• To our knowledge, no other company has yet generated an antibody capable of depleting LAG-3 expressing activated T cells

• Up to ₤64m in total upfront and milestones + royalties

• A phase I study comprising two cohorts has completed in healthy subjects (Part A) and has commenced in patients with psoriasis (Part B)

• Pending results of the phase I study and any future clinical development plans, regulatory filing by GSK potentially between 2021-2025*

• *GSK 2015 investor presentation: Slide 108

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IMP701 update
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• Phase I milestone received August 2015

• LAG-525 derived from IMP701, in ongoing clinical trials in context of melanoma, lung and renal cancer

• Works by blocking LAG-3-mediated immune down-regulation (removes brake)

• In June 2016, Novartis amended their trial to increase enrollment from 240 to 416 patients and added a third treatment group to the trial that involves treating Japanese pts.

• Estimated study completion date is October 2018

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CVac™
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• May 2016 - Sale and Licensing Agreement with Sydys to advance CVac ™ Program

• Prima received a 9.9% equity stake in Sydys for the assets being transferred

• In the event of successful commercialisation of CVac, Prima could receive milestone payments and low single digit royalties on sales

• Provides opportunity for second chance for CVac

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The Market Opportunity for IMP321

Activator and Inhibitor

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The global cancer immunotherapy market is expected to reach

• • US$35 Billion by 2023 World-wide Q2 2016 sales for the following drugs were

• Yervoy® (US$241m), Opdivo® (US$840m), Keytruda® (US$314m), Tecentriq® (19m CHF)

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*Citi Research: Immunotherapy the beginning of the end. Andrew Baum 22 May 2013

• Prima together with its partners, is the global leader in developing LAG-3 related products (IMP321, IMP701 and IMP731)

• Increasing global R&D of LAG-3 related product candidates – we are in the right space!

clinical trials	pre-clinical trials
Novartis (Prima’s partner)	Agenus
GSK (Prima’s partner)	Tesaro
BMS	Sanofi/Regeneron
Merck	Macrogenics
Boehringer Ingelheim	Peregrine Pharmaceuticals
	RXi Pharmaceuticals Corporation/MirImmune, Inc

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IP Portfolio
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• 12 patent families providing broad protection across all LAG-3 assets

• Comprises 89 pending or granted applications excluding those licensed to GSK and Novartis

• Protection for methods of use of IMP321 may extend to 2036 excluding SPC or term adjustments

• Regularly review our R&D activities to file new improvements wherever possible

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Opportunity in Metastatic Breast Cancer
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• 30% of breast cancer patients have metastatic disease (at diagnosis or more frequently through recurrence)[1] and 2 out of 3 are HR positive[2]

• Metastatic breast cancer (MBC) patients have a median survival of 2-4 years[3]

• 5-year relative survival rate is approximately 22%[4,5]

• MBC currently remains almost incurable[6]

• In the U.S., annual indirect cost to society attributable to MBC for women under 65 was estimated to be over US$ 572 million including[7] :

US$ 270 million Premature deaths US$ 253 million Lost productivity US$ 50 million Caregiving

The global breast cancer treatment market will reach US$17.2 billion by 2021.[8]

1. O’Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. The Oncologist. 2005

2. American Cancer Society. (2014). Hormone therapy for breast cancer. Breast Cancer. Accessed on September 30, 2014 from http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-hormone-therapy.

3. Mosher, C. E., Johnson, C., Dickler, M., Norton, L., Massie, M. J., DuHamel, K. (2013). Living with metastatic breast cancer: A qualitative analysis of physical, psychological, and social sequelae. Breast J, 19, 3, 285-92.

4. http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-survival-by-stage

5. Madell, R. Metastatic breast cancer: Life expectancy and prognosis. Healthline. 2014 at http://www.healthline.com/health/breast-cancer/metastatic-prognosisF# Overview1.

6. American Cancer Society. (2013). Detailed Guide: Breast cancer. American Cancer Society. Accessed on September 6, 2014 at http://www.cancer.org/acs/groups/cid/documents/webcontent/003090-pdf.pdf.

7. Sorensen , S. V. et al. (2012). Incidence-Based Cost-Of-Illness model for metastatic breast cancer in the United States. International Journal of Technology Assessment in Health Care, 28,

8. 1,http://dx.doi.org.proxy1.athensams.net/10.1017/S026646231100064X.

9. http://www.researchandmarkets.com/research/mg3gms/breast_cancer

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Metastatic Breast Cancer Market

• HER2[-] HR[+] patient group is our primary target

• Potential label extension is feasible

• AIPAC: study in hormone receptor-positive (ER[+] PR[+] ) metastatic breast carcinoma patients with IMP321 + paclitaxel

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1
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Primary
target
patients
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• Global incidence of new cases of all breast cancer is estimated at 1,671,149 cases/yr of which 20% will potentially become metastatic (Globocan 2012)

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1. Decision Resources 2010

Commercial Development Strategy

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Work in Progress
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• Active business development

• Manufacturing discussions ongoing to secure future clinical and commercial supply of IMP321

• International Nonproprietary Name (INN) filed – to be announced 2017

• Active research

• Opportunity for IMP321 approval by EMA – subject to Ph IIb positive results

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UPCOMING MILESTONES AND SUMMARY

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Upcoming Milestones
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Clinical
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Other
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• Dec 2016: Safety-run-in results of AIPAC: immuno-monitoring data and safety data; first TACTI-mel data

• Q1 2017 Start of randomised phase for AIPAC

• Potential milestones from development partners in the coming years

• Continued expansion of IP

• Q1 2017: TACTI-mel: Dose escalation

• Throughout 2017: TACTI-mel results from different cohorts

• R&D for new products

• Updates regarding LAG-3 landscape

• Mid 2017 Efficacy data from AIPAC Safety Run-in (15pts)

• 2017: First results of INSIGHT study

• Ongoing business development

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Summary
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• We have multiple ongoing clinical developments with several value inflection points

• We have strong partners with demonstrated commitment to continued development in clinical phases

• We have a solid cash position and sound financial management

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NASDAQ: PBMD, ASX: PRR

Thank you!

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