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Prima Biomed Ltd. (NASDAQ:PBMD)

FQ4 2013 Earnings Conference Call

August 5, 2013 7:00 p.m. ET

Executives

Matthew Lehman – CEO

Sharron Gargosky – Chief Technical Officer

Marc Voigt – Chief Business Officer & CFO

Analysts

Brad Dunn – Ord Minnett

[Management presentation will be updated shortly].

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). The first question comes from [Kerry Willett], Private Investor. Please go ahead.

Unidentified Analyst

Good morning. My question is actually for Sharron Gargosky. With regard to the release of the ICS test results, I'm wondering what you expect these to show in relation to the results that were released last year?

Sharron Gargosky

Hi Kerry, nice to talk with you.

So with the ICS data, what we're looking at now is, you know, last year when we presented data, I had a snapshot that I could share, which was a handful five CVac patients and a couple of patients that were standard of care. So, we were looking at them. What we didn't have was the longitudinal assessment of a patient across the dosing period. So what we're looking at with the data right now is patients at baseline prior to their treatment and then looking at them during the course of CVac treatment and looking at how their immune profiles respond. You know, where do you get the best peak of response? What are you seeing there during the course of treatment? And that's our primary focus right now.

And then subsequently, the longitudinal piece, the secondary piece of that will be how long is that response able to be maintained or do you see a duration that's detectable in an assay like the ICS. So, our first evaluation is looking at patients from baseline through the course of dosing, and we're looking at, as we said, all 63 patients. So, we're trying to get a really much bigger data set than just the small snapshot that I had access to at the end of last year.

Unidentified Analyst

Thank you very much. May I ask a question if possible to Mr. Lehman with regard to the increased volume trading on the Prima shares on NASDAQ recently, and if there might be some intelligence or reason that he's aware of behind that?

Matthew Lehman

Yeah. Hi, Kerry. Sure. You know, I don’t know if I -- I mean it may -- I think it's probably just a simple of an answer as, you know, we've been increasing our time here in the US, introducing the company to the investor community. I think it's an interesting, you know, look, it's an interesting story. I do think biotech has been, you know, it's a bit of a hot market in the US right now. So, I think that background is also helpful for the story we're telling, and certainly immune therapy, this niche in cancer treatment is also a bit exciting right now. There was ASCO which was held in Chicago, and just about a month or so ago, two months, you know, and immune therapy is really gaining a lot of traction in the scientific community, also now let's say reaching over into the financial community.

So I think that's really what it is, just explaining our story and meeting with people and explaining what we're doing. So I think it's exciting though. It is nice to see that we're really getting the interest and following on let's say both Australia and the US exchanges.

Unidentified Analyst

Great. Thank you very much both for your answers.

Matthew Lehman

Yeah.

Sharron Gargosky

Thank you.

Matthew Lehman

Thanks Kerry.

Operator

The next question comes from [John Ryan], Private Investor. Please go ahead.

Unidentified Analyst

Thank you. My question is involving the foreign exchange position. It was mentioned in your report that things are at about $1.4 million, $1.5 million foreign exchange gain. I'm just wondering what the position is with the company and its cash holdings. Is it exposed to the Australian dollar weakening in recent times? And what is the company's foreign exchange hedging policy?

Matthew Lehman

Marc, do you want to --

Marc Voigt

Yeah.

Matthew Lehman

-- more specific?

Marc Voigt

Yes. So, yeah, thanks very much for the question. First of all, we hold significant positions in euro and in US dollars, which is giving us a nice buffer in terms of the decrease of the Australian dollar which we have been seeing. In the past and also ongoing into the future, we have hedging contracts which are based on our projected ongoing operations which are following, we believe, a reasonable assumption based on the risks from foreign exchange. However, also moving forward, as mentioned, as we have a substantial amount of euros and US dollars on bank, we are in a comparably good position given that most the clinical operations run in Europe and United States.

Matthew Lehman

Okay. Thank you.

Operator

Thank you. The next question comes from [Diane] and [David Costello] with (inaudible). Please go ahead.

Unidentified Analyst

Good morning, Matt and team. I've got a question regarding the Australian presence. Has Prima considered a stronger Australian media presence, (inaudible) the chairman and other directors to make public statements?

Matthew Lehman

Yeah, thanks, David. I mean I think in general, yes, I mean we're, you know, I think it's important for companies like us to get our message out. So, yeah, I mean the short answer is yes, you know, we certainly take the opportunity both on the financial community as well as the media to take some opportunities to be able to explain our story – tell our story in the media. I will say I think let's say more recently a bit of our focus has shifted to the -- I mean at some point we're still a small company and we had to pick our priorities. So, there probably has been a little more focus on the US side, and part of that is because, you know, just to say the level of visibility and the general knowledge about Prima Biomed in the US is a bit lower. In Australia, I think it's important that we're kind of able to make up that gap.

Yeah, but I think absolutely, I mean it's something we look at it, it's something we do. And I would expect – however, we also want to be careful with let's say bombarding people with over-communicating, because that can also turn people off. So, we try to keep this in balance with, you know, when we really have news, we really try to get that out through the proper channels, as well as maintaining the ongoing interest. Does that kind of answer the question, David?

Unidentified Analyst

Yes. Yes, thanks. Matt, if I could ask a second question, I know I've already raised this one, but in Australia, breast cancer seems to dominate in terms of the media, which is fair enough. But has Prima considered trying to put a public space for ovarian cancer, in particularly using somebody -- a high-profile media person, I have mentioned before, Pierce Brosnan who lost both his wife and daughter to ovarian cancer as the public face champion of CVac?

Matthew Lehman

Yeah, thanks, David. I mean I think where we are in development, I think we'd be a little bit cautious on some of those, you know, we -- especially let's say on the breast cancer side, and this will be the first trial of CVac in breast cancer, you know, so I think as we're progressing through clinical development, it will be nice. We'll work with the doctors, we'll have the patients joining the trials, we'll have the data to support that. And then we'll look at how we present the data that we have coming out of these trials in that way. But I think we're -- we'll kind of proceed with some measure of I'll say conservatism as we have more and more data on these trials.

Unidentified Analyst

Okay. Thanks, Matt. Thank you.

Matthew Lehman

Yeah, thanks.

Operator

Thank you. The next question comes from Brad Dunn with Ord Minnett. Please go ahead.

Brad Dunn – Ord Minnett

Hi guys. Thanks very much for the call. Just a few questions from me on the CANVAS trial. Could you give a sense of how many clinical centers -- production centers you're aiming to eventually open? If possible, any sort of [guide] (ph) around the average productivity of a clinical center in terms of how many recruitments they can achieve in a month or a quarter or something like that?

Matthew Lehman

I mean, Sharron, you want to address that one or?

Sharron Gargosky

Yeah. Yeah, I'd be happy to. So you were asking about the number of centers we're looking at setting up, the number of investigators in these trials, and kind of what kind of metrics we actually have for the CANVAS trial.

You know, what we are anticipating right now is, you know, we put in our protocol up to 120. We have up to about 80 centers that we're actually targeting that are our clinical centers, some of which are centralized around the blood collection groups that we have. So, we are targeting probably up to about 50 of those.

I think importantly when you start looking at patient recruitment and the metrics, it really is very center-specific. Some of the -- some centers are larger and recruit a lot of ovarian cancer patients if you have a particularly renounced surgeon or a well-known oncologist, and they're the centers of course we've been trying to target, the large ones per country that have a really phenomenal referral area, so we'll get the right type of patients into this trial.

But even with that being said, we need to be sensitive that these patients are being attained -- as soon as they've been diagnosed with ovarian cancer, we're trying to get these patients between surgery and chemotherapy to be involved in the study. And so, there's a lot on the patient with regards to you've just been diagnosed, and now will you also be part of a trial. So, I think the real heroes on our program are really the women who step up to be part of the study. And that being said, there are a large number of phenomenally brave women out there who are offering to be part of trials. And depending on the country, we may see anything from a half to about a patient per clinical center per month, depending on what we're -- where we're looking and how many patients their referral areas are.

So we've tried to plan our trial to ensure we're able to maximize our manufacturing centers across the globe that we're able to recruit patients and not disappoint anybody, but still attain good-quality products on each of those centers. So there's a number of metrics and pieces that are being played into this puzzle to get that kind of recruitment moving in the study.

Does that help answer some of your questions?

Brad Dunn – Ord Minnett

Yeah. No, that was a great answer. Thank you very much.

Operator

Thank you. (Operator Instructions).

At this time, we're showing no further questions. I will now turn it back over to Mr. Lehman for closing remarks.

Matthew Lehman

Yeah. Okay. Well, thank you, [Nikki], and again thanks everyone for joining us. We appreciate the interest of course and the ongoing engagement with Prima and what we're doing. So we look forward to speaking again next quarter and keeping everyone up to date. Thank you.

Operator

Ladies and gentlemen, thank you for your participation on today's conference. This does conclude our conference for today. You may now disconnect your lines.

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