EX-99.1 2 d497338dex991.htm EX-99.1

EX-99.1

ASX:PRR; NASDAQ:PBMD; ISIN:US74154B2034

First half-year results for FY 2013

(period ended 31 December 2012)

Supplemental Information for Prima BioMed Conference Call

on March 7, 2013

1

Exhibit 99.1

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’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

CVac Overview

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

internalized by the DCs

The DCs washed,

formulated, and

frozen as 1ml vials

Manufacturing of CVac

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

3

Company strategy

Developing personalized immunocellular

therapeutics for cancer

Establishment of a robust global supply, logistics,

and manufacturing platform leads to clinical and

commercial success

Video review of Prima’s manufacturing is available at

http://primabiomed.com.au/movies/movie_5.php

Goals: monetize our assets through commercial

product partnerships or licenses; increase value

through continued investment in our operational

platform and deepen our product pipeline

4

Manufacturing development

•

Scaled up manufacturing of the mucin antigen (M-FP)

•

Achieved comparability of product manufacturing in three global

facilities (Australia, USA, Germany); demonstrates our capability to

transfer the technology into new facilities and it paves the way

for

future scale up into larger facilities when needed

•

Implemented automated logistics management software –

coordinates manufacturing facilities, dozens of cell

collections

centers, hundreds of hospitals, the couriers, our

laboratories, and Prima’s quality managers around the globe

•

Customized and validated shipping materials for CVac to allow for

greater flexibility in the shipping timelines for CVac

•

Inspected and approved 45 cell collection centers that will be able to

collect blood product for making CVac across 13 countries; plan for 52

cell collection centers in 15 countries integrated into our quality

system through CY 2013

•

Planning for careful scale up of production capacity from 63-patient

trial to nearly 1000-patient trial

5

Clinical development –

ovarian cancer

•

Focus of Prima’s development has been on

newly diagnosed, stage III/IV, epithelial ovarian

cancer patients who achieve remission after

standard first-line debulking surgery and

platinum/taxane chemotherapy

•

Significant unmet medical need and low levels of

potential competition

•

EOC is receptive to immunotherapy approaches

•

Targeting patients with low tumor burden

reasonably intact immune system

6

Clinical trials –

ovarian cancer

•

CAN-003: positive interim data reported in

October & November 2012:

–

Trend of improved PFS in CVac patients

–

CVac induces a mucin 1 specific t cell response

•

CAN-003: upcoming data for all 63 patients:

–

Final immune monitoring data in 3   quarter of CY

2013

–

Final PFS and initial OS data in 4   quarter of CY 2013

•

CAN-004 (CANVAS): status update:

–

Underway in 4 countries and 26 clinical sites

–

Controlled rollout through 2013

7

th

rd

Financial results for the Half-Year

ended 31 December 2012*

Loss after tax: A$ 8,030,406

Loss per basic and diluted share: 0.75 cents (A$ 0.0075 per share)

Loss is down 13.78% to corresponding period last year:

Loss after tax: A$ 9,314,047

Loss per basic and diluted share: 0.92 cents (A$ 0.0092 per share)

G&A expenses: appx A$ 2.6 million (down from A$ 3.3 million)

R&D expenses: appx A$ 7.3 million (down from A$ 7.5 million)

Cash & term deposits: appx A$ 28 million

(does not include A$ 1.4 million accrued during the reporting period but

received after the reporting period in February 2013)

*according to International Financial Reporting Standards (IFRS). 

Results to be read in conjunction with notes from the Company’s

Half-Year Report and previous year’s Annual Report, both published

in compliance with ASX listing rule 4.2A.

8

Income statement for the Half-Year

ended 31 December 2012*

(unaudited)

31 December 2012

31 December 2011

A$

A$

OTHER INCOME

Total other income

2,079,220

3,031,479

EXPENSES

Depreciation and amortisation

(118,138)

(78,922)

Research and development and intellectual property

(7,279,338)

(7,515,131)

Corporate administrative expenses

(2,607,964)

(3,281,424)

Changes in fair value of derivative financial instruments

(37,190)

(1,470,049)

Loss before income tax

(7,963,410)

(9,314,047)

Income tax expense

(66,996)

-

Loss for the half-year

(8,030,406)

(9,314,047)

*according to International Financial Reporting Standards (IFRS). 

Results to be read in conjunction with notes from the Company’s

Half-Year Report and previous year’s Annual Report, both published

in compliance with ASX listing rule 4.2A.

9

Exciting year ahead

•

Continued scale up of manufacturing and

expanding our cell collection network

•

Phase 2 results in ovarian cancer trial:

–

3Q CY13 –

immune monitoring profile

–

Q4 CY13 –

PFS and OS data

•

Continued rollout of CANVAS

•

CVac opportunities for other cancer targets

in phase 2 / POC trials

10