Full Press Release Details
PRIMA BIOMED DISCUSSES FIRST HALF OF FISCAL YEAR 2013 RESULTS EARNINGS CALL TRANSCRIPT
Matthew Lehman, Chief
Marc Voigt, Chief Financial Officer
Sharron Gargosky, Chief Technical Officer
Anton Uvarov, RM Capital
Chris Kallos, Edison
Luca Pancratov, Roth Capital Partners
Ren Benjamin, Burrill & Company
Zara Lyons, Nomura Group
Prima BioMed (ASX: PRR; NASDAQ: PBMD) First Half of Fiscal Year 2013 Results Earning Call 7th March 2013 9:00am AEST
gentlemen and welcome to the Prima BioMed Limited quarterly conference call for the half-year ended December 31, 2012. My name is Anita and I ll be your moderator today. At this time all participants are in a listen only mode. We will
conduct a question and answer session towards the end of the conference at which time if you wish to ask a question you ll need to press star followed by the number one on your telephone keypad. I d now like to turn the conference over to
Mr James Moses, Prima s investor relations representative. Mr Moses please proceed.
James Moses: Investor Relations
Prima BioMed Ltd, Level 7, 151 Macquarie Street, Sydney NSW 2000
Phone: +61 2 9276 1224 Fax: +61 2 9276 1284
Thank you. Good morning everyone, we re delighted that you could join us today for Prima BioMed s
inaugural quarterly conference call. With me is the company CEO Mr Matthew Lehman, our Chief Financial Officer Mr Marc Voigt and also Dr Sharron Gargosky, Prima s Chief Technical Officer.
Before we begin I d like to make a comment regarding forward looking statements and remind you that during this call we will be making forward
looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward looking statements. Reference to these risks and uncertainties are disclosed in detail in our public
announcements to the ASX and our disclosure filings with the US Securities and Exchange Commission.
With that now taken care of I d like
to turn the call over to Prima s CEO, Mr Matthew Lehman.
Matthew Lehman: Chief Executive Officer
Thanks James and hello everyone, thanks for joining today. This is our first conference call that we ve done such as this. It s a real pleasure
to have everyone and we here at the company look forward to doing this every quarter going forward to make sure we help keep everyone up to speed on a regular basis as to the progress and the developments going on here at Prima.
This is an exciting time for the company; the past half-year has seen us make some significant strides in refining our business strategy, consolidating
our leadership position in this emerging field of immunocellular therapeutics. I ll be turning over the call shortly to Dr Gargosky and Mr Voigt to review our R&D progress and then our finances respectively. Before we do that I just want to
give a little background.
As most of you know our main product is called CVac, this is an autologous immunocellular product. We combine a
patient s own mononuclear cells, it s a type of white blood cell that matures into dendritic cells and we combine those cells with a mucin-1 human fusion protein to make a product that s specific to each patient. So these cells are
formulated then as a cryo-frozen 1ml vial for intradermal injection. We typically obtain six or more doses from each time we do a production run and that s sufficient for a full course of dosing as we re studying in our clinical trials.
The goal then of CVac is to stimulate a killer T-cell response that s directed at the cancer cells over expressing this mucin-1 antigen target. So the idea here again is using personalised cells to target very specific marker present on cancer
Prima BioMed Ltd, Level 7, 151 Macquarie Street, Sydney NSW 2000
Phone: +61 2 9276 1224 Fax: +61 2 9276 1284
More broadly, I mean we see the promise of such therapies, these types of personalised immunocellular
products such as CVac, these anti-cancer products can be very potent, highly specific and minimise the toxicity one usually experiences with more traditional cancer treatments. So as we re in this space we believe the key to the clinical and in
particular the commercial success of these types of personalised cell based products and what we also consider is the long-term value driver for our company is the establishment of a robust global, supply, logistics and manufacturing platform. We
think our manufacturing platform and the internal regulatory experience discussing our product now with about 15 agencies around the world combined with what we would hope is going to be robust clinical data from our ongoing trials will put us in a
pretty strong position to negotiate potential partnerships or other types of commercialisation opportunities for CVac and for our technology in the future. We also believe it gives us multiple opportunities for value creation and namely the ability
to look at some other immunocellular therapies to bring into our development pipeline.
So with that intro, I d like to turn over to
Sharron and she ll talk a bit more about the details of our R&D efforts.
Sharron Gargosky: Chief Technical Officer
Thanks Matt and good morning to everyone on the call. I m really pleased to be able to provide a review of our latest progress in
both our manufacturing and clinical development. Firstly, on the manufacturing side we have achieved a large number of important milestones with our CVac program. We have scaled up the manufacturing of the mucin antigen as we refer to it as MFP and
have been continuing our research and development on the characterisation of MFP which as you know is one of our key starting materials and the product that is CVac and the component that is critical for the specificity and potency of our product.
We have achieved comparability of the product manufacturing in three global facilities; that s Australia, the United States and Germany.
And the process demonstrates really our capability and capacity to transfer this technology into new facilities and really paves the way for future scale-up into the larger facility when it s needed.
Prima BioMed Ltd, Level 7, 151 Macquarie Street, Sydney NSW 2000
Phone: +61 2 9276 1224 Fax: +61 2 9276 1284
We have implemented our automatic logistics management software that coordinates and informs our
manufacturing facilities, our dozens of cell collection centres, our hundreds of hospitals, our couriers, laboratories and the Prima quality managers around the globe. The logistics management software also interfaces with the manufacturers to
generate country specific transport, packaging and labelling so these requirements allow us to have a far greater control across all of our sample logistics. We have customised and validated our shipping materials for CVac allowing us to have a
greater flexibility in our cold chain and shipping timelines for our product.
We have inspected and approved now 45 cell collection centres
globally that will now be able to collect blood products for the manufacture of CVac in now 13 countries. And over the course of this calendar year of 2013 we intend to have 52 blood collection centres in 15 countries integrated into our quality
So in summary we re very pleased with the development of our manufacturing platform and the successful interface we now have
among the clinics, logistics, and manufacturing to support the global CVac program. I look forward to being able to regularly keep our shareholders updated on the continued progress.
We have planned carefully for a major scale-up of our production capabilities in moving from 63 patients in the CAN-003 trial to nearly 1,000 patients in the CANVAS trial. As our next steps, we are
planning for the longer-term scale-up of a commercially viable manufacturing and logistics system to support what will be a marketable CVac.
On the clinical side in the clinical development, we have put most of our effort into the clinical trials of CVac for the potential to treat newly
diagnosed stage III/IV epithelial ovarian cancer patients, those who have achieved remission after the standard first-line optimal debulking surgery and the platinum/taxane chemotherapy. This is an area where we really see an unmet and a significant
medical need where there s very low levels of potential competition.
The literature suggests that epithelial ovarian cancer is receptive
to this immunotherapy approach and we believe that one of the best places to test such products is in patients who have the low tumour burden and with an immune system that s reasonably intact. We certainly see that the safety profile of CVac
is one of its potentially biggest advantages. Clinical data thus far has indicated no toxicity associated with the treatment and most adverse events have been relatively mild or transient.
Prima BioMed Ltd, Level 7, 151 Macquarie Street, Sydney NSW 2000
Phone: +61 2 9276 1224 Fax: +61 2 9276 1284
We reported positive interim data from our ongoing CAN-003 clinical trial of CVac in ovarian cancer in both
October and November of 2012. This interim data was presented at the International Gynaecological Cancer Society meeting by Dr Jeffery Goh and co-investigators. And in this interim analysis there were encouraging trends of increased progression free
survival for patients receiving CVac compared to the control group in the ongoing CAN-003 trial. Based on these initial analyses of seven patients from CAN-003 we were also able to demonstrate that CVac induces a mucin-1 specific T cell response in
During the calendar year of 2013 we expect two important data points from the CAN-003 trial. In the third quarter of calendar year
2013 we plan to release the immune monitoring profile from all 63 patients in the trial over multiple time points during the course of the study. In the fourth quarter of calendar year 2013 we will have the final protocol analysis of progression
free survival and the first evaluations of overall survival. At the same time we will have continued our controlled roll-out of the CAN-004 trial that s also referred to as CANVAS.
The current status of the CANVAS trial is as follows: The protocol has been approved by regulators in 10 countries including Australia, Belgium, Bulgaria, Belarus, Germany, Latvia, Lithuania, Poland,
Ukraine and the United States. Ethics committee s approvals have been attained in 14 countries. And of our inspected and trained cell collection centres, 22 centres are now active and eligible to start receiving patients to start the trial.
Twenty-six clinical centres have been activated by Prima and allowed to start recruiting patients; that s in Australia, Belarus, Ukraine and the United States.
To date we have 32 patients who ve consented to participate and have been screened. Twenty-five have met the study criteria eligibility and have been randomised into the trial. Four have been dosed.
As we recently announced we have commenced patient recruitment for CANVAS in Europe and we will be authorising additional new clinical trial
sites and expect a significant increase in the numbers of patients on the trial throughout the course of 2013. In summary, we believe we have a well thought out clinical development plan for ovarian cancer and I really look forward to sharing the
data as it becomes available in the coming months.
Prima BioMed Ltd, Level 7, 151 Macquarie Street, Sydney NSW 2000
Phone: +61 2 9276 1224 Fax: +61 2 9276 1284
Now I d be happy to turn the conversation over to Marc to review the financials of the company.
Marc Voigt: Chief Financial Officer
Thank you very much Sharron and good morning also from my side. Before I start my review I would like to mention a few key details. Consistent with the Australian Standards regulation, Prima reports
financials according to Australian Accounting Standards, abbreviated AASB, which is in line with IFRS or the International Financial Reporting Standards. All numbers we are talking about will be in Australian dollars. Our financial year runs from
July 1 through June 30 so it s a non-calendar fiscal year. We are currently reporting half-year results for the first half of our fiscal year 2013 and not just the past quarter. These half-year results have been reviewed but not
audited by PWC. Prima has 1,066,000,000 ordinary shares outstanding and an additional 43.8 million options over ordinary shares outstanding as well. There s only one class of shares in the company. Prima has no debts other than routine
current accounts payable. There are some minor accrued tax liabilities and employee benefits.
For the six months ended December 31, 2012
the company reported a loss of A$8,030,406 or 0.75 cents per basic and diluted share compared to a loss of A$9,314,047 or 0.92 cents per basic and diluted share for the same period in 2011. On the income side, we accounted for approximately A$1.5
million in grant income primarily from the Australian R&D Tax incentive program and we also earned about A$590,000 in interest.
general and administrative expenses were approximately A$2.6 million down from the corresponding period in 2011 when we had G&A expenses about A$3.3 million. In part, this reduction is due to the higher expenses we had a year ago in preparation