IMMUTEP LIMITED — Investor Presentation 2012

Oct 17, 2012

Developing personalized bio-therapeutics

Investor Presentation October 2012

ASX:PRR; NASDAQ:PBMD; ISIN:US74154B2034

Important Notice

The purpose of the presentation is to provide an update of the business of Prima BioMed Ltd ACN 009 237 889 (ASX:PRR and 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 contact Prima BioMed and/or refer to the Company's website 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 Ltd’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 Limited. 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.

Forward Looking Statements

The statements in this presentation regarding the future and commercial prospects of Prima including statements regarding the efficacy of CVac™, the timetable and success of clinical trials and the potential market for CVac™are forward looking and actual results could be materially different from those expressed or implied by such forward looking statements as a result of various risk factors. This presentation contains certain "forward‐looking statements". Forward looking words such as, "expect", "anticipate", "believe", "likely", "intend", "should", "could", "may", "plan", "will", "forecast", "estimate", "target", "aim" and other similar expressions are intended to identify forward‐looking statements. Indications of, and guidance on, future earnings and financial position and performance are also forward‐looking statements. Forward‐looking statements, opinions and estimates provided in this presentation are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current market conditions.

Forward‐looking statements including projections, guidance on future earnings and estimates are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. The expectations reflected in these statements may be affected by a range of variables which could cause actual results or trends to differ materially including the risk factors summarized in appendix I. The forward‐looking statements involve known and unknown risks, uncertainties, and other factors, many of which are outside the control of Prima, and its directors, officers, employees, advisers, agents and affiliates.

Forward‐looking statements only speak as to the date of this presentation and Prima assumes no obligation to update or revise such information or to reflect any change in management's expectations, from the date of this presentation, with regard to any change in events, conditions or circumstances on which any forward‐looking statement is based. The forward‐looking statements included in this presentation involve subjective judgment and analysis and are subject to significant business, economic and competitive uncertainties, risks and contingencies, many of which are outside the control of, and are unknown to, Prima. Given these uncertainties, you are cautioned to not place undue reliance on such forward‐looking statements. There can be no assurance that actual outcomes will not differ materially from such forward‐looking statements.

Prima Biomed: Snapshot

Key metrics

ASX Code: PRR (Australian Stock Exchange) Shares on issue: 1,066.1 million Share Price: A$0.145 Market Capitalization: ~A$155m Cash Position: A$38.0m (as at 30 June 2012) Avg Daily Trading Volume: ~A$0.8m

Board of Directors

Ms. Lucy Turnbull AO Chairman Mr. Albert Wong Deputy Chairman Mr. Matthew Lehman Managing Director and Chief Executive Officer Mr. Martin Rogers Non-Executive Director Dr. Richard Hammel Non-Executive Director

*All market references as at 15 October

Prima BioMed: Mission

• Mission: Develop novel and high-value personalized bio-therapeutic products with a focus in immune cell therapy for oncology.

• Lead product: CVac™ is made of autologous dendritic cells pulsed with mannanmucin-1 fusion protein. In advanced clinical development for ovarian cancer .

• CVac potential: overexpressed protein Mucin-1 is also present in other cancers such as breast, renal, bladder, colon, pancreas, lung and stomach.

• Background: Intellectual property and early research developed by the Austin Research Institute (now Burnet Institute) in Melbourne, Australia

• Technology: Global platform (formulation, manufacturing, regulatory, distribution) for development of personalized bio-therapeutics

Prima BioMed is a world leader in the development of personalized bio-therapeutics

Prima BioMed: Leadership

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Mathew Lehman
CEO
Extensive global management
Dr. Sharron Gargosky experience & execution of 100s Marc Voigt
Chief Technical Officer of clinical trials in US & EU Chief Business Officer
Biochemist with 17 + years 14+ years in corporate and
development experience and biotech investment sectors and
approvals for orphan diseases executive biotech management
Dr. Neil Frazer Ian Bangs
Chief Medical Officer CFO & Company Secretary
Physician with 23+ years 25+ years experience in finance
experience in drug development & compliance for a number of
and executive management public companies
Marta Schilling
VP Manufacturing
25+ years in manufacturing
operations, product
development and cell therapy
1
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General Cancer Market

• Estimated 24.6 million people in the world living with cancer

• World Health Organization (WHO) has predicted: global cancer incidence will increase by 50% between 2000 and 2020

• Cancer becomes increasingly common in both developed and developing countries due to the increasing age of the population, unhealthy lifestyles as well as better and earlier diagnostics and detection, there is a significant need for new, innovative therapies

• Cancer is one of the largest, most rapidly growing markets in the pharmaceutical industry

• World oncology market expected to surpass $78 billion by 2012

Ovarian cancer – an unmet medical need

• Annual incidence of epithelial ovarian cancer in Australia & “major markets” (USA, Japan, UK, Germany, France, Italy, Spain) ~ 61,283 p.a. (2010)

• 70-75% diagnosed in late stage ~ 44,400 p.a.

• 70-80% of those achieve remission ~ 33,300 p.a.

• Since ovarian cancer is generally diagnosed at a late stage, only 20-30% of patients with late stage disease survive for 5 years*

• A maintenance treatment like CVac™ would be the first of its type in this new market and the company has potential to achieve market penetration within the first year

• The global market size for ovarian cancer therapy expected to surpass $US1.2bn in 2012

• Thomson Business Intelligence, Ovarian Cancer Therapeutics Industry Analysis 2007

Immunotherapy for cancer

• Induce and/or enhance a body’s immune response to target and kill cells that express certain antigens

• Immunotherapy has the potential to be highly potent and specific against tumor cells with an excellent safety and toxicity profile

• Research into cancer immunotherapy has led to recent regulatory approval success:

• Dendreon’s Provenge® approval in 2010 (FDA)

• Bristol-Myers Squibb’s Yervoy® approval in 2012 (FDA)

• Key concepts for development:

• Selection of antigen(s) target

• Management of manufacturing and logistics

• Choosing the patients most likely to benefit

Prima’s Technology & Platform

 Cryopreserved cell formulation → minimizes cell collections (leukapheresis procedures) from patients and reduces cost

 Intradermal injections → maximizes delivery of maturing dendritic cells to drain to lymph nodes and migrate to tumor cells

 Automated logistics → labeling with bar codes and digital management of the entire supply chain minimizes errors and optimizes use of human resources and facilities

Prima’s Technology & Platform

• Cell collection expertise → 40+ qualified and trained cell collection centers worldwide to provide material for high-quality products

• Global breadth

→ experience in tech transfers, comparability protocols, and regulatory licensing of manufacturing facilities in Australia, USA and Germany

 Mucin-1 multiple opportunities → mucin-1 is overexpressed on numerous other cancer types; Prima has a unique immunogenic sequence and companion diagnostic to move in other indications

• New product opportunities → ability to grow the pipeline based on company strengths

CVac™ Targeting Ovarian Cancer

CVac - Prima’s Lead Product

• Autologous dendritic cells (DC) pulsed with recombinant human fusion protein (mucin-1–glutathione-S-transferase) coupled to oxidized polymannose (mannan)

• In development to treat epithelial ovarian cancer patients in complete remission after first-line surgery and chemotherapy

• Excellent safety profile to date (3 clinical trials)

• Global, well-designed Phase II/III trial (“CANVAS”) underway

• Recently released data yields important positive trends

• Mucin 1 specific cellular response 9

• Increasing time in remission for ovarian cancer patients

Antigen Target: Mucin-1

Normal MUC1

Tumor MUC1

• more complex O-linked sugar chains

• simpler and fewer sugar chains

• glycosylated

• underglycosylated

• tandem repeat sequence (VNTR-variable number tandem repeat)

• “naked“ structure carbohydrate and peptide epitopes are exposed

CVac Overview

Manufacturing of CVac

MNCs (white blood cells) taken from the patient by apheresis and sent to lab

MNCs separated and matured to decdritic cells (DCs) with growth factors

DCs are pulsed with the antigen Mannan-Mucin-1 Fusion Protein (MFP)

Mucin-1-antigen is The DCs washed, internalized by the DCs formulated, and frozen as 1ml vials

Mechanism after injection

Mucin-1 is overexpressed on ovarian cancer cells

Cvac administered as 4 intradermal injections at each dose

CVac activates CD8+ T- cells specific to mucin 1

T cells target mucin 1 overexpressed on cancer cells

T cells kill cancer cells

Clinical development

Phase	Name	Indication	Patients
I	CAN‐001	Terminal cancer adenocarcinoma	10
		(breast, ovarian, fallopian tube, colon,
		lung, oesophageal)
II	CAN‐002	Ovarian cancerpatients with no further	28
		treatment options
II	CAN‐003	Ovarian cancerpatients in remission	63
		after 1st or 2nd line therapy
II	CAN‐003x	Ovarian cancerpatients who have	~20
		progressed on CAN‐003	(est)
II/III	CAN‐004	Ovarian cancerpatients in remission	800
		after 1st line surgery and chemotherapy	(est)

CAN-003 Study Overview

• Protocol:

• 63 epithelial ovarian cancer patients enrolled in complete remission after successful 1[st] or 2[nd] line chemotherapy

• 7 non randomized CVac; 29 randomized to CVac; 27 to observation standard of care

• Objectives:

• Primary: progression free survival (PFS) as defined by CA-125

• Overall survival (OS)

• Prove biological activity by intracellular cytokine staining (ICS)

– Establish comparability between 2 global manufacturing sites

• Confirm safety of CVac™in patients in remission

• Results:

• Manufacturing comparability established

• CVac™ well tolerated to date; no therapy-related toxicity

• Dosing complete for all patients in 4[th] quarter 2012

CAN-003 Interim Safety Data

CVac is very well tolerated

• Only 1 SAE possibly related to CVac treatment

• Total of 5 serious adverse events (SAE) in the CVac arm (2 disease progression, abdominal pain, small bowel obstruction and febrile neutropenia) compared to 2 SAE in control arm (abdominal pain; hematoma/respiratory failure leading to death)

• 7 severe adverse events noted (bunion, headache, cough, itch , flu‐ like symptoms and urinary tract infection)

	NRCVAC & CVAC	NRCVAC & CVAC	NRCVAC & CVAC		OSC			Total
		(N=36)			(N=27)			(N=63)
Adverse event	# Pats	%	# AEs	# Pats	%	# AEs	# Pats	%	# AEs
severity
Mild	29	80.6	218	20	74.1	129	49	77.8	347
Moderate	16	44.4	57	6	22.2	14	22	34.9	71
Severe	6	16.7	14	1	3.7	2	7	11.1	16
Death	0	0	0	1	3.7	1	1	1.8	1

CAN-003 Interim Efficacy Data

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Promising trend
in PFS data
First
Median PFS remisson
(as of Aug 2012)
NRCVac: 421 D
CVac: 365 D
Control: 321 D
Second
remisson
7
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CAN-003 Immune Monitoring Data

Inital 3 patients analyzed by intracellular cytokine staining (ICS) – demonstrate significant increase in mucin 1 specific cytotoxic T cell activity after first 3 doses of Cvac

Understanding Immunotherapy

Summary data from ipilimumab phase III trial of patients with previously treated, unresectable stage III or IV melanoma

S. O’Day et. al. J Clin Oncol 28:18s, 2010 (suppl; abstr 4)

				Comparison	Comparison	Comparison
	**Ipilimumab **	Ipilimumab + gp100	gp100	Ipilimumab vs. gp100	Ipilimumab + gp100 vs. gp100	Ipilimumab + GP100 vs. ipilimumab
OS rate, % 12 mo 24 mo	46 24	44 22	25 14	—	—	—
OS, median, mos	10.1	10	6.4	HR = 0.66 p = 0.0026	HR = 0.68 p = 0.0004	HR = 1.04 p = 0.7575
PFS, median, mos*	2.9	2.8	2.8	HR = 0.64 p = 0.0007	HR = 0.81 p = 0.0464	HR =1.25 p = 0.0371

*Medians are similar; however, PFS curves part after the median as reflected in HR.

Understanding Immunotherapy (2)

PROVENGE provided a survival benefit for every year studied in the IMPACT phase III trial

http://www.provenge.com/hcp/survival-rate.aspx

Phase II/III – CANVAS

CANVAS ( CAN cer VA ccine S tudy) is multinational, multi-center, randomized, double-blinded, placebo-controlled for a robust analysis, started in Feb 2012

• Stage III/IV patients eligible after optimal debulking surgery

• 800 patients randomized 1:1 CVac : placebo

• Patients must be in complete clinical and radiologic remission after chemotherapy to continue dosing

• 6 doses in 44 weeks

• Dosing starts as soon as possible (~2-3 weeks after chemotherapy)

• About 120 centers globally (USA, Australasia, Europe)

CANVAS goals

• Validate and plan for a commercial-ready manufacturing process in 3 global regions

• Validate a companion Mucin-1 diagnostic test

• Confirm acute and longer-term safety and tolerability of CVac™in a larger patient population

• Establish CVac efficacy by PFS and/ or OS

• Investigate CVac impact on quality of life factors

• Exploration of biomarkers and cellular activity

Significant progress: key milestones

• Phase I CAN-001 Trial completed

• Phase II CAN-002 Trial completed

• NASDAQ Listing

• Development of manufacturing, logistics and quality control procedures (three manufacturing centers)

• Phase II/III Trial design regulatory approval in Australia and U.S and different European nations

• Phase II/III Trial enrollment commenced

• Interim Phase II CAN-003 Trial data released

Outlook

• Key milestones (all subject to exact timing of patient outcomes)

• ICS (immune) data for next cohort of 7 patients (4Q 2012)

• Initiation of exploratory trial in new cancer indication(s) – pending ICS data (~2Q 2013)

• Final CAN-003 ICS data (3Q 2013)

• Final CAN-003 efficacy data (4Q 2013)

• Phase II/III CANVAS data (~2015)

• Other catalysts in the next 12 months

• Comparability with 3[rd] manufacturing center (Europe)

• All blood collection centers globally qualified and approved

• All CANVAS sites globally initiated

Conclusion

• Ovarian cancer presents a significant unmet medical need

• CVac would be the first of its type in the market, with potential to achieve rapid market penetration

• Positive data from CAN-003 demonstrate a favorable safety profile and provide indication of CVac’s efficacy

• Phase II/III Trial CANVAS underway across multiple sites with patient enrolment to accelerate in 2013

• Manufacturing and logistical capabilities have been developed and provide a platform for development to scale

• Significant milestones anticipated through 2013 – 2014