Lite Strategy Inc (LITS) 2010 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Marshall Edwards year-end conference call. My name is Yvette and I will be your conference operator for 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 call. (Operator Instructions).

I would now like to turn the call over to Mr. Pete De Spain, Senior Director of Investor Relations. Please proceed, sir.

Thank you, Yvette. On behalf of Marshall Edwards, I would like to welcome everyone to our fiscal year-end 2010 conference call.

Before we get started, I want to call your attention to the fact that this conference call may contain certain forward-looking statements within the meaning of the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements which are based on management's current expectations and are subject to a number of risks and uncertainties as discussed in our SEC filings including our most recent Annual Report on Form 10-K filed on August 30, 2010.

Now with that said, I would like to introduce our speakers for today. With me on the call I have Dan Gold and Tom Zech.

As most of you know, Dan was appointed as President and Chief Executive Officer a few months ago. Tom joined us as Chief Financial Officer shortly thereafter.

Tom will start with a high-level overview of our fourth quarter and fiscal year 2010 financial results, after which Dan will provide an update on the Company and our lead programs along with our plans moving forward and we will open up the lines for questions. I'll now turn the call over to Tom.

Thank you, Pete. I'm very pleased to be with you today and grateful for the opportunity to provide a financial overview of the Company. For more detailed information, I invite you to review our 10-K filed just this past week.

As you know, Marshall Edwards is a development stage oncology company. So jumping right in, our loss for the fourth quarter of 2010 declined to $1.8 million compared with $5.4 million for the same quarter in fiscal year 2009.

This was due to lower clinical development expenses in 2010 related to the OVATURE trial which closed enrollment during the fourth quarter of fiscal year 2009. Also during the fourth quarter of fiscal year 2009, the Company expensed a milestone payment of $2 million related to the license for drug candidate triphendiol and NV-143.

Now moving to our full-year results, our loss of the fiscal year ended June 30, 2010 was $7.9 million compared with $11.2 million for the same period in 2009. This represents a decrease loss of $3.3 million.

The decrease was primarily the result of lower clinical development spending following the closure of our Phase III OVATURE trial. This was partially offset by an increase in development costs related to our next-generation drug candidates as well as general and administrative expenses which included additional costs for the establishment of a new US headquarters and management team.

In addition, license fees paid to Novogen in fiscal year 2010 decreased to $1.5 million compared to $2 million paid in 2009. As of June 30, 2010 we had cash resources of approximately $9 million compared to $19 million at June 30, 2009.

This decrease in cash was primarily due to the loss from operations in 2010 of $7.9 million and the payment of accrued clinical expenses related to the OVATURE trial which amounted to approximately $2.2 million of the additional cash that was used. We believe our existing cash balances will be sufficient to fund our current year operating plan and can carry us into our next fiscal year. I'll now turn the call over to Dan for more insight into the plan.

Thanks, Tom, and thank you all for joining us this afternoon. Earlier this year I was approached regarding a leadership position here at Marshall Edwards. After a thorough review of the Company and its programs, I ultimately accepted the position for the same reason I have come to learn that many of you remain invested in the Company because I believe in the science.

Marshall Edwards was built on the fundamental premise to develop novel cancer therapeutics based on the central design of naturally occurring compounds called isoflavones. We've screened more than 400 of these compounds for their anticancer properties.

The results of these efforts to date is what I believe to be two very exciting programs with related but distinct mechanisms of action. Each of these programs directly target tumor metabolism, critical for cancer cell survival.

The first and most advanced is our NADH oxidase or NOX inhibitor program, a family of compounds that include phenoxodiol, a name that has received much exposure of late. Soon after I joined the Company, we unblinded the results of our randomized Phase 3 OVATURE trial of orally administered phenoxodiol plus carboplatin in women with recurrent ovarian cancer.

More than one year and a half after the trial closed, there was less than half of the original number of patients enrolled. As we reported, the results determined that the trial did not show statistically significant improvement in either of the study's endpoints, progression free survival or overall survival.

While disappointing, there were several valuable takeaways from the OVATURE trial that should benefit us greatly as we prepare for upcoming clinical studies. The most essential lesson addresses the optimal route of administration for this particular class of drugs.

To emphasize this point, consider the fact that only one of 142 patients enrolled in OVATURE achieved a clinical response in either arm. In contrast, six of 20 patients or 30% responded to intravenous phenoxodiol plus cisplatin in an earlier Phase 2 trial.

While we all know it's difficult to compare results from two trials with different study designs, these results are supported by pharmacokinetic studies demonstrating that significantly higher levels of active drug are measured when our compounds are administered intravenously as opposed to the oral route. Despite indications that IV phenoxodiol may be a viable drug candidate, we no longer intend to pursue its development at this time.

The reason for this is quite evident. We have even more potent next-generation analogs of phenoxodiol, namely triphendiol and NV-143.

NV-143 in particular appears to demonstrate far superior antitumor activity against a broad range of tumor cell lines compared to phenoxodiol. Importantly we have demonstrated that triphendiol is metabolically converted to NV-143 in vivo, making NV-143 the straight forward choice as our lead product candidate for this program.

As such, we're in the process of completing drug manufacturing of NV-143 and expect to be back into the clinic early next year with an IV formulation. We remain very encouraged regarding this program and look forward to updating you on its progress.

Now let me turn to our other lead program in which we have identified isoflavone analogues with a mechanism of action distinct from our NOX family of compounds. I'm referring to our novel mTORC1 and mTORC2 pathway inhibitor program.

The majority of preclinical studies conducted to date within this program have been on a compound we call NV-128. These studies have demonstrated that unlike NV-143, NV-128 induces a (inaudible) independent cell death by way of both tumor cell DNA fragmentation and a process of destructive autophagy, a natural process wherein a cell actually consumes itself. Much of this work has been performed in collaboration with Dr. Gil Mor at Yale University.

NV-128 appears to work upstream from mTOR, inhibiting both the mTORC1 and mTORC2 complexes. This differs significantly from approved rapamycin analogues on the market which target only mTORC1.

NV-128 has shown to be as effective as rapamycin in preclinical animal models but with far less toxicity and has also shown to be active on rapalog-resistant cell lines that we are now developing in-house. Furthermore, studies by Dr. Mor have demonstrated that 128 is active against chemotherapy-resistant ovarian tumors system cells that he has derived from patients.

Even more encouragingly, we have now identified a potential natural metabolite of NV-128 in a compound we call NV-344. In preliminary studies, NV-344 demonstrates far superior antitumor activity when compared to NV-128.

We are in the process of finalizing our lead identification studies for this program after which we plan to conduct the necessary animal toxicity studies and initiate a Phase 1 trial at about this time next year. As I hope you can see, we remain 100% committed to our isoflavone platform and confident in its potential.

To that end, we announced this morning that we have agreed in principle to acquire the entire isoflavone related intellectual property portfolio from Novogen in a stock-based transaction. We believe that this proposed acquisition will provide us greater flexibility in developing those compounds we are already working on while enabling us to explore other potential product candidates within the portfolio.

My goal since day one has been quite straightforward, namely to give our programs the best possible chance of succeeding while further developing the potential of the platform. Over the past four months, we have established our headquarters here in San Diego. We've added an oncologist with extensive industry and clinical experience to our Board of Directors in Dr. Christine White.

We've identified our lead product candidates on the heels of the OVATURE study and most recently taken significant steps towards securing our future growth through the proposed acquisition of what we believe are very valuable assets. Clearly, we have lots left to do. But as we continue to work diligently towards optimizing our clinical development plan, I believe we are now well positioned for success going forward.

And with that, I believe we are now ready for questions.

(Operator Instructions) Mark Monane, Needham & Co.

Good afternoon from the east and congratulations for the team for the first call as a team together. Nice work.

Thanks, Mark.

I know, Dan, that you are new to the Company but I also know that you have been thinking about cancer, chemotherapy and cancer therapeutics for a while and mTOR has been around for a while as well. And I was wondering if you could comment some more on 143 because I sensed your excitement there.

What is going to be the key factor? Is it the complete inhibition of mTOR? Is it both the 1 and 2? Is it in combination with other drugs? How do you envision thinking about 143 going forward?

Sure, Mark, just a brief correction. It's actually the 128 program that is the mTOR inhibiting pathway.

You're absolutely right in the sense that when we think about cancer, we really have to think about compounds that act to complement other standards of care. Clearly we are now appreciating, it has been appreciated for some time that simply inhibiting the the mTOR1 pathway with the currently available compounds doesn't seem to be sufficient in making a large difference in the patient's outcome and that has suggested that the mTOR2 pathway must be playing a critical role or an essential role as well.

The reason that we are excited about our series of compounds, 128 and 344, is that they appear to inhibit both of these pathways at a point somewhat above the mTOR pathway. So the net result is that these cells actually become primed and ready to die upon the administration of our compound.

So we think that especially in the case of 344 or 128 that these compounds will play a very important role, potentially an important role when used in combination, particularly in the ovarian cancer studies that Dr. Mor has been conducting at Yale.

That's helpful. And speaking of working in combination, can you tell us how many people now at the Marshall Edwards and what is the optimal number in your opinion going forward for 2010 and beyond?

Sure, our current structure is that here in San Diego, we are building out our management team with first at the hire of Tom. We brought on a very accomplished chemist, Dr. [Moreno], who is a Harvard trained organic chemist to help oversee the studies from this side of the pond.

We have a very efficient, a very established research group in Sydney that has carried the entire history of the Company with them. And I think going forward this year, we will be looking to build out a critical nucleus of clinical expertise starting with our Chief Medical Officer as well as building out our regulatory group. The financials -- currently our duties are directed by Tom here in San Diego and we rely in large part from help with our Sydney friends and that's how we are proceeding currently.

Thanks very much for the added information, look forward to upcoming events.

George Iwanyc, Oppenheimer.

Wondering if you could expand on the transaction with Novogen as much as you can in terms of the nature, the value you are attributing to it and maybe you could expand a bit on what you see as the future relationship with Novogen given that they currently control over 70% of you. What will they have in the future, how will you work together, etc.?

Thanks, George, for asking that. So right now we have reached an agreement in principle as we said in the announcement. We believe that the transaction that we were contemplating is -- would maximize the benefit for the shareholders of both Novogen as well as Marshall Edwards.

Clearly, I am sure you are aware, transactions of these sorts take a little bit of time to make sure that they are fair to both parties and that is the process that we are working through right now. So we are not commenting directly on the value that we have placed on it.

We believe this transaction is being negotiated by the independent subcommittee of both boards. We believe that we have reached a fair and equitable price for both companies.

And clearly because it is a stock-based transaction, the success that we have at Marshall Edwards in developing this platform will clearly flow back to the shareholders of Novogen. I'm afraid that's about all I can say in that regard just right now.

So the way that you'll work with Novogen in the future, can you say anything about that at the moment?

Right, so as I said on the previous question, right now it is our intention to maintain the research group within Novogen and we rely heavily on their expertise and their history as we continue, especially with this proposed acquisition.

As we develop further expertise in looking at platform more completely, we will be significantly calling on them to aid us in that venture. So right now as we envision it, the corporate day-to-day activities will be centered here in San Diego and more of the R&D efforts will remain in Sydney with the Novogen group.

George Zavoico, MLV.

Congratulations on your quarter and the progress you have made in the last couple of months since you have been there. Just a follow on on George's question regarding Novogen and how you're going to use the resources in the future.

It seems to me that clearly you have to concentrate on getting the compounds into the clinic and you are probably looking at backup compounds. But is it fair to say that the clinical trial costs are going to increase in the course of the year relative to the R&D costs? And if you could comment, if you can give any guidance on what you expect, how much of the resources you expect the Sydney group will take in the next year.

This is Tom. The Sydney group, you know, is really fully accounted for in our plan for next year. So their role going forward will probably remain similar to where they have been in the past.

What we have done and what we've disclosed in our 10-K is we plan to take forward triphendiol or 143 or one of the analogs, we'll take that forward into early human trials or Phase 1 trial. At the same time, we will continue -- we have planned to continue to develop on the preclinical basis 128.

So, in about a year, the Phase 1 of 143 should be ongoing, should've started, maybe even halfway through if you started early next year? And you would be about ready to begin with one of the mTOR inhibitors to begin a Phase 1 trial about this time next year? Is that fair to say with regard to what your milestones might be?

Yes, George, I think that's quite accurate. It is my goal to get these compounds as quickly as we can into the clinic and through their early stage testing so that we can actually then begin some efficacy-based studies.

So, we will get 143 or it is our intention to get 143 in early in next year, next calendar year, and hopefully if that goes as planned, be positioned at some point later in the year to begin the Phase 2 studies while we initiate the Phase 1 studies with the 128 or 344 compound.

And final question and maybe premature, but can you comment at all on any business development talks that you have had or are having?

Well, I think you know, as we stated in our 10-K, we do have sufficient resources to get the 143 program into the clinic, into the Phase 1 studies. Biotech is a business that is always in need of new resources and of course in this world, that comes primarily from selling equity or partnering and we clearly will explore both of those avenues as we move forward.

I think with the proposed acquisition, that will potentially open some doors for partnering discussions. But we clearly remain focused on getting our two lead oncology compounds into the clinic as quickly as we can and get them funded in the most efficient way that maximizes their value.

So it seems to me that what you're saying is that one of the objectives of getting the IP was to make the BD talks a little bit more -- a little bit less complicated, put it that way?

Yes, I think so.

Great, thanks very much.

[Ed Irvine], private investor.

I was wondering -- well most of my questions have been answered. But you have enough money to go to the fiscal year -- what day is your fiscal year?

Our fiscal year encompasses July 1 through (inaudible)

So theoretically, you said you could probably get the 143 in trial before that fiscal year is up. You are going to have to raise some money somehow pretty soon, I would imagine. And I'm just trying to figure out, at these prices, how would you possibly do that?

Yes, well, as I just mentioned and as we said in the 10-K, we clearly will need to be raising new sources of revenue and we will be exploring both mechanisms of doing that, both through the sale of equity and through potential partnering discussions. And we'll do whatever is best for the Company and with the eye of the shareholder in mind.

Can you start a partnership? I mean, what phase do you have to be in a trial before you can even think about a partner? I was just trying to -- to me, we've got two really exciting drugs that could revolutionize cancer and I'm just trying to figure out how to get them through the trials.

Sure, clearly our goal is to maximize the value of these assets and there are a number of ways of going about that. There are of course companies that are looking for very early stage assets as they consider how to build out their long-term pipeline and we would clearly be interested in speaking with them.

There are other companies that are out there looking for slightly more mature compounds and we will be talking to them as well and there are certainly mechanisms where people can put bets down and still be able to capitalize on the back end. So I think we're open to considering all opportunities that come our way and we will be actively pursuing them with the mind of raising sufficient capital in order to get these compounds to a value creation point.

Have you been able to talk to -- where do you stand with the authorities on whether -- you know with the reverse split? And now we're a peck over one dollar today, thank goodness. But how do we stand on the de-listing problem?

As you probably know on our 10-K, we disclosed the deficiency notices that we received from NASDAQ to date. We had a date coming up which is November 15 where we are going to be required to cure the shareholders equity deficiency.

That will be the first one that will come up. And as you know, some of the issues we have is that it is currently -- the only -- we will have to raise as Dan just talked, we will have raise some additional equity or -- there's probably a couple of ways to do that. And certainly even this transaction that we've announced this morning will also help raise shareholder's equity as well. So we'll have to get something done fairly quickly in order to cure that deficiency.

From my understanding on the -- what was said today, there's no cash involved in buying these isoflavones from Novogen. It's going to be all stock?

That's correct, yes.

Okay, but we have no idea how many shares? I mean, I have got -- I'm a shareholder of both of them, so I've got concerns on both sides and will that be a shareholder vote?

Yes, as what the announcement said today, the final terms of the proposed transaction will be subject to a shareholders vote from both companies.

Well good luck, because I swear I think this is -- I've been in this Company a long time and I believe in the drugs like you do and the compounds and I'm just hoping we could -- is there anything in the old trial that we could use, I mean in the ovarian trial?

Is there anything in there that we could use -- to the FDA that we have something that works? I'm just trying to find some pieces that we could parlay to help us.

I understand your question and I think that those of us who have been in biotech and cancer drug development for a long time understand that it's a long and often torturous road and we try and learn at every turn lessons and new information. And as I said in my comments, I do believe that we have learned significantly from the OVATURE trial several lessons.

And unfortunately, the data are just not sufficient to consider discussions with the FDA on any sort of a marketing path currently. It would take a significant investment of time and future clinical trials in order to establish whether phenoxodiol is of value to patients. And based on our analysis, we really feel that with the superiority of 143, it is better worth our time and our investment to pursue that program rather than trying to continue development of phenoxodiol.

Well really good luck. I'm pulling for you.

[Jim Iatrides], private investor.

Good afternoon, Dan, Tom, Pete. I'm very glad to see you join the Company. Like Ed who was on before, I've been in this Company a long time. I'm a big believer in the science, felt very let down by the management and what would be the past makeup of the Board of Directors.

I have a series of questions for you. First, with regard to phenoxodiol oral versus IV, and I'm asking this not so much for phenoxodiol, but for lessons learned in moving forward as you said. Graham Kelly spent a lot of time in his book writing about going from IV to oral and how everything they did showed that it was bioavailable and a form that could be de-conjugated within the body and so forth except for blood cancers and spent a lot of time on it.

Yet we had some positive -- somewhat positive results on sine Phase 1 and Phase 2 trials with phenoxodiol in both the IV and the oral formulations. And then all of a sudden in OVATURE, we literally just got killed. What is it that you know about the availability of the oral form versus IV that we somehow missed or was missed by the Company before?

Sure. So, I think we need to take a step back. This is obviously the absolute most critical point that we have had to face as we try and make some heads or tails out of the OVATURE study. This is the very first thing I dug into significantly in trying to understand what the OVATURE trial was telling us.

And I think the conclusions that I have come to is not at all dissimilar from what Graham himself as come to that as you mentioned, this class of compounds is not unique in the sense that they do get conjugated and inactivated and there is some suggestion and that has proven out in our own Phase 1 studies that certain tumor types at varying degrees are able to de-conjugate these compounds and reactivate them.

The issue that I think we're facing is at what level does that occur and is it sufficient as a monotherapy to evoke a significant clinical response. And I think that the answer to that is, it is not sufficient.

The absorption of these compounds through the intestinal tract is at best 30 to 40% and they do get directly conjugated as they pass through the intestinal wall, so that 100% of the compound that is delivered is conjugated, some fraction of which will make its way into the tumor before it is excreted and some fraction of that will then be de-conjugated.

Now I think that we don't have to look any further than the example of Avastin to appreciate the importance of combination therapies in cancer. Avastin itself which is a revolutionary drug that is one of the largest sellers on the marketplace as a monotherapy is rather ineffective and only shows its significant efficacy when used in combination with chemotherapy.

I think that is probably a likely outcome for our compounds, should they prove to be efficacious, that while they do show monotherapy activity in manipulated animal models and in cell culture, their true value will probably be as chemotherapy sensitizes or ability to work in combination with existing chemotherapies. That said then, we need to figure out how to get as much possible drug into a cancer while the chemotherapy is there and the only way to do that based on our own pharmacokinetic studies and our pharmacodynamic studies is to give it IV.

We know from our studies and data that was done by Novogen and Marshall Edwards over the years that we can get at least 100 to 1000-fold higher levels of free drug for a short amount of time if we administer it intravenously. So putting those all together, I think if we were developing this for a rather indolent monotherapy approach -- for a cancer that was rather rather indolent where a monotherapy may have some effect like in low-grade prostate cancer, something like that, then perhaps an oral route would be potentially of efficacy. However on these more aggressive faster growing cancers, we really have to hit them and hit them very hard and the best way to do that is to hit them with an IV formulation in combination chemotherapy.

Very good, Dan. Follow-up question on that. With regard to say NV -- triphendiol or NV-143 and then NV-128 or 344 if you decide to leapfrog that, do you have a suitable carrier for each of those drugs? I know phenoxodiol IV used cyclodextrin originally. Do you have a carrier that works with 143?

We are currently I think committed to a different delivery vehicle than the beta-cyclodextrin that was used in the earlier phenoxodiol studies. We have identified a compound, we have tested it in our labs.

This is a compound that has been used by major pharmaceutical companies in the delivery of other hydrophobic type small molecules that are similar in class to our set of compounds. And as I said, they are now -- this carrier has been incorporated in a number of marketed products.

So that is the road that we are planning on going down and then with the 128 and 344, we will continue to explore if this solution is the optimal one or if we can come up with an even more optimal one for 128, 143.

Well these carriers require a license fee to somebody?

Quite possibly, yes.

Next question real quick. I don't know how much you can answer this. But will Novogen research eventually go to Marshall the way the IP has?

I'm sitting here wondering why we maintained what I'll call a dysfunctional corporate structure for so many years having these two companies, even though Chris Naughton originally said he was creating value doing so. But it's pretty obvious the value was not created. It's gone the other way.

We have not had formal discussions of taking the research group in under the Marshall Edwards umbrella. Certainly that is something that we would definitely contemplate.

But at present, we have had our hands full with a number of activities we have been trying to accomplish up to now. Right now, I am happy with the arrangement we have currently with Novogen. Currently if things change, we will re-examine that and make a determination if it would be more efficient to just bring that those under our own wing if it's appropriate.

And I do understand you have done a lot in a very short period, even though it's great that you finally had this call and you couldn't have it prior to having a meaningful call. But it's obvious that you guys have been doing a lot.

A couple of real quick questions. In terms of -- it was mentioned in terms of raising money and partnering, at what point will you be looking for a partner? Let's say you've raised some money to get through some basic Phase 1 and maybe a Phase 2 trial or two.

At what point do you bring in a partner? Because all of us have been promised that this company would never go to a Phase 3 without a partner yet we did and did so with disastrous results. So my question is really, what is your strategy? And you have obviously been around the block.

I think that it's a difficult question to answer. I think the role of biotech may or may not necessarily be to try and take a novel compound all the way through a pivotal Phase 3 trial and market it themselves and oftentimes that is necessary.

You look at your product and think it has a significant profile that any one of a number of partners should just jump at the opportunity and they don't jump. So you're forced to make a decision and to carry forward.

As I said, I have been doing this for a while and it's always been my objective in my past and with this compound that we will take this as far as necessary to create what we think is the maximal value that we can and then at that point try and seek a partnership for it. So that doesn't necessarily (multiple speakers)

I mean, is that Phase 1, Phase 2 or somewhere in between?

It's a good question and unfortunately I don't think there's a single answer. As I mentioned, I think in the previous question, we find as we talked to different companies in my past that there are companies out there that are looking for different compounds that have different profiles either very early depending on where they are in their drug development cycle and where they need to fill in their own pipeline.

So we will clearly explore every avenue early and late and we don't want to partner so early that we leave a lot of money on the table. But if that is necessary to promote these programs, if that's the only way we can gain the resources we need to promote them, then we will have to look at that.

Optimally we would like to be able to demonstrate that OVATURE was an anomaly and that this platform is significantly important and that we can formally demonstrate that and find a suitable partner.

That leads into the next one. I'm getting close to the end, my next question, and that is in terms of the whole strategy of partnering, a number of us over the years have watched these deals where you see these companies getting hundreds of millions of dollars based on some Phase 1 results in terms of a partnering deal and we have not seen that.

And I sit there and say why is that. Is that our drugs stink or they don't work? I don't think so. I mean, I don't think I have seen anything with a safety profile like this and still show efficacy whether it is in some of the mono early cervical mono or in some of the combo therapies or whatever.

But one of the things I have seen is this companies traditionally just put out a lot of press releases on a trial but never fully document and submit their data to peer review publication. So one thing I've heard is that no one is taking this company serious and my question is one, is that something you're going to start doing and get done and is there anything that will come out of the earlier trials in terms of them being documented to show safety and efficacy? And then related to that, when will data come out on the lost deal trials, the cervical trial final and the Sanofi trial, the taxane in combination with phenoxodiol?

Right, so just a general statement to your question. I do have an academic background and I do believe very strongly in peer review publications because it's not only important for everyone to know what your successes are, but where your failures are so we can all learn in the field on how to best move forward for patients.

That said, we sponsor these trials with our academic collaborators and they are often encouraged to publish and we are fully supportive of that. So there are as you said a number of studies that have occurred over the years with oral phenoxodiol and a few with the IV formulations and there are manuscripts that are being prepared currently for a number of those studies and I do monitor that and we will get that information out as best as we can.

Sometimes it's not always up just to the investigator. It's up to the peer review to determine if the data are worthy of publication.

So certainly I am not at all against publication. On the contrary, I'm very much for it. So, we will be monitoring it. We will be encouraging all of our investigators to publish as they believe it's time.

What you're saying is you are moving forward on documenting past trials so that we have a library or history of what has happened with this family?

Yes.

Very last question, board members. You added Christine White to the Marshall board. I believe that was a very good choice.

I actually have some acquaintances and friends who know her and they were able to say that she was definitely someone who would bring something to the party with this Company. My question is, what additional Board members will be added to Marshall and/or Novogen if appropriate so that we have not only more balance in terms of the scientific and medical community, but more balance also in terms of the business community and maybe somebody who represents the shareholders Or has come from the shareholder group?

Well, first off, I certainly can't comment on changes at the Novogen Board level. I'm not -- it's not in my purview and I don't have any knowledge way or the other about that.

All I can speak about is Marshall Edwards. And I think your point is very well taken. And when I came on, I looked at the composition of the Board and I had serious discussions with the existing Board and it was completely acknowledged that we did need medical expertise, certainly in oncology, and that's why I reached out to Christine first and foremost.

I totally agree with you though that there are other potential deficiencies that could possibly be addressed from the business and the drug development world. And certainly as we move forward with ways of financing the Company, we will be looking for individuals who can help round out the composition of the Board and make it certainly an instrument that we can rely on to help us as we proceed in our development plans.

Very good, Dan. I just want to thank you, Tom and Pete. I'm very glad that you're here. I wish you were here five or six years ago.

Thank you, Jim.

Thanks, Jim. I'm glad we're here now and we certainly will try and do our best to do whatever we can to get this program back on track.

With no further questions in the queue, I would now like to turn the call back over to Mr. Dan Gold for closing remarks. You may proceed, sir.

On behalf of the entire Board and the management team at Marshall Edwards, I want to thank you for your continued support. I know it's been tough and I sincerely appreciate you sticking with us. We look forward to updating you on our progress as we go forward and I think this is going to be a very exciting year ahead, so please stay tuned.

Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Have a great day.