CASI Pharmaceuticals Inc (CASI) 2010 Q1 法說會逐字稿

Good morning, and welcome to the EntreMed's first quarter 2010 update call.

(Operator Instructions).

I will now turn the call over to Mr. Michael M. Tarnow, Executive Chairman.

Thank you, Carrie, and good morning. And thank you to each of you for your interest and your participation in today's call. Before we begin with the update on our clinical program and our financial status, let me just go through a few of the formal -- forward-looking statements -- remarks. The comments made during the call will contain some forward-looking statements. They do involve some risks and uncertainties regarding our operations, and future results of the Company. I encourage you to review our SEC filings, including our 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. The contents of this call contain some time sensitive information. That information is accurate as of today's date. EntreMed undertakes no obligation to revise or update any statements, to reflect events or circumstances after the date of this call.

Joining me this morning is Dr. Carolyn Sidor, our Vice President and Chief Medical Officer. I do want to begin by thanking Carolyn, and I want to thank the other officers of the Company, Cynthia Wong Hu, Kathy Wehmeir-Davis, and Mark Bray for their efforts during the past year to year and a half, in meeting our objectives, and moving EntreMed 2076 forward into Phase 2 clinical development. The purpose of today's call is to bring you, our investors, those interested in our Company, up to date on our clinical development activities, as well as our planned milestones in the near future related to our lead drug candidate, ENMD-2076, as well as a brief review of our first quarter financial results. Those results were the subject of a press release that went out this morning.

Let me say that our Board, our senior management team, remains confident in the Company's clinical development strategy, and our capabilities to execute that strategy. In late 2008, the Board did an extensive review of our activities. At that time, concluded that we should focus our human and financial resources on 2076, as our priority drug candidate for development. While the Company had, and continues to have, several other compounds in its portfolio that we consider assets, we believe that the development of 2076 represents the most direct path for creating value for the Company, and for it's shareholders. Through careful management of our resources, our strategy has been successfully executed, and we've achieved a number of important milestones, the milestones we established in 2009 for the development of this oncology product.

As a clinical stage Company, our goal is to develop and commercialize 2076 for the treatment of cancer. Since our re-prioritization, we completed or initiated three Phase 1 studies, Carolyn will talk about those in some detail, in solid tumors, multiple myeloma and leukemia. Most recently, we met a significant milestone for the Company, when the 2076 program was initiated in multi-center Phase 2 study in ovarian cancer patients in April of this year. Carolyn will, in the next several minutes, summarize our work to date, and point out upcoming significant events in our development path. At this point, I would like to turn the call over to Carolyn to review our clinical progress, our objectives for the 2076 program. I'll come back and talk for a few minutes about the -- our -- the financial results for the first quarter. And then we'll have an opportunity to address your questions and comments. Carolyn?

Thank you. As Michael has stated, EntreMed's focus is on the clinical development of ENMD-2076. We chose this path based on a number of factors, including ENMD-2076 unique combination of kinase targets, the excellent preclinical activity that was demonstrated in a number of tumor models, ease of manufacturing, and the ability to combine ENMD-2076 with standard agents already on the market for various oncology indications. ENMD-2076 is a novel orally-active, Aurora A/angiogenic kinase inhibitor, with activity against Aurora A and multiple tyrosine kinases linked to cancer and inflammatory diseases. Aurora kinases are key regulators of the process of mitosis, or cell division, and are often over-expressed in human cancers, 2076 therefore combines both antiproliferative activity and the inhibition of angiogenesis in a single molecule.

We've recently completed a multi-center Phase 1 clinical study in patients with advanced solid tumors. The Open-Label study conducted at the University of Colorado and the Dana Farber Cancer Institute was designed to assess safety, pharmacokinetics, and clinical benefit end points in patients with solid tumors. We also measured soluble VEGFR2, or KDR as part of the study's pharmacodynamic evaluation. Data from the Phase 1 study in solid tumors has demonstrated that ENMD-2076 administered in daily oral doses was associated with clinical benefit, as demonstrated by reductions in tumor markers, reduction in tumor volume, and improvement in cancer-related symptoms without substantial toxicity. These benefits were observed in patients with a variety of tumor types including ovarian, melanoma, renal cell, liver and colorectal cancers. Among the participants of the Phase 1 study were 20 patients with resistant or refractory ovarian cancer that were treated with single agent daily oral 2076. These patients had a medium progression free survival of 16 weeks.

Additionally, the combined response rate using RECIST and CA-125, a tumor marker in ovarian cancer criteria, is 40%, with an objective response rate using RECIST or tumor measurements alone of 10%, and a confirmed CA-125 response rate of 30%. The median number of these heavily pre-treated cancer patients for prior chemotherapeutic regimens was five, and the response to ENMD-2076 was independent of prior therapy, including prior Bevacizumab therapy or Avastin therapy. Results compared favorably with agents currently on the market for treatment of platinum-refractory and resistant ovarian cancer patients, such as liposomal Doxorubicin or Doxil, and topotecan that reported medium progression free survivals of 9.1 or 13.6 weeks.

Single agent Bevacizumab in a less heavily treated group of ovarian cancer patients was associated with a medium progression free survival between 4.4 and 4.7 months. Therefore, we selected ovarian cancer as our initial Phase 2 indication. And has been stated already by Michael, earlier this quarter, we initiated a multi-center Phase 2 study for ENMD-2076 in platinum-resistant ovarian cancer patients. The primary objective of this study will be to determine the progression-free survival rate of patients at 6 months. This is a meaningfully -- clinically meaningful end point. 60 patients are expected to be enrolled in the study that will be conducted at six sites in the United States and Canada.

According to the American Cancer Society, approximately 21,500 new cases of ovarian cancer, and about 14,600 deaths occurred in the US in 2009. Unfortunately, in most cases, about 60% are diagnosed at advanced stage and chemotherapy is the standard of care. But despite aggressive treatment, survival rates are poor, and the five-year survival rate is about 45% for all stages. New agents are clearly needed for this difficult to treat patient population. In addition to the Phase 2 study in ovarian cancer, Phase 1 studies in multiple myeloma and leukemia are on-going.

Early data for the Phase 1 study in patients with relapsed or refractory acute myeloid leukemia were presented at the AACR EORTC NCI meeting last November. Treatment with single agent ENMD-2076 was associated with anti-leukemia activity, and we continue to evaluate the patient characteristics and possible predictive biomarkers for this population. EntreMed has been granted orphan drug designation from the United States Food and Drug Administration for ENMD-2076 for the treatment of ovarian cancer, multiple myeloma and acute myeloid leukemia.

Our expectations for ENMD-2076 clinical development in 2010, include to have all of the sites in our Phase 2 ovarian study enrolling patients prior to ASCO this year, to submit the Phase 1 solid tumor study data for publication this summer, to present data for the Phase 1 study in multiple myeloma and leukemia later this year, to complete enrollment for the Phase 2 study in ovarian cancer, and to present initial efficacy data for the Phase 2 study in ovarian cancer early in 2011. I will now turn the call back over to Michael.

Thank you, Carolyn. Both Carolyn and I look forward to addressing your questions, after a brief review of the financials. I appreciate Carolyn's summarizing why we're excited and enthusiastic about 2076's potential in the treatment of a variety of cancers, and appreciate her work and that of her staff to bring the program to this state that it's now in. Now, I would like to provide a brief review of our current financial position.

Yesterday, we filed a report containing financial results for the three months ending March 31, on a Form 10-Q. The press release went out this morning, and it should be available to all of you. The net loss for the first quarter 2010 was $2.1 million or $0.03 per share, as compared to $3.5 million or $0.04 per share for the same quarter of 2009. As of March 31, 2010, the Company had cash and short term investments of approximately $9.7 million. In addition to that sum, on April 16, we announced the registered financing, totaling gross proceeds of approximately -- of $3 million. The Company as we sit today, has cash and short term investments to support our current and planned activities through the fourth quarter of 2010. We expect to record royalty revenues on 2010 sales of THALOMID by Celgene in the fourth quarter of this year. We will continue to maintain tight control of our financial spending, and we will be opportunistic with regard to raising additional capital.

Thus far in 2010, excluding the April financing which I mentioned, we have completed three registered financings to a single institutional investor, for a total of $8 million in gross proceeds. We received a number of inquiries from investors, regarding our compliance with the NASDAQ $1.00 minimum closing bid requirement. As we announced previously in March, we received a decision letter from the NASDAQ hearing panel, granting our request to extend the compliance date from January for an additional 180 days until July 16, 2010. As a result of this the decision by the panel, our stock will continue to trade on the NASDAQ capital market until that date, by which time our minimum closing bid price must have exceeded $1.00 for ten consecutive trading days.

If our stock continues to trade under $1.00, the Board will consider alternatives in order to maintain the public trading status of our stock. These options include electing to implement a reverse stock split, with the approval of our shareholders, or listing upon other exchanges. We as a Board have not made a final determination as to whether to effect a reverse split, as we continue to have an opportunity to meet the $1.00 minimum closing bid price during the 180-day extension period, and other options are available to us. When that decision is reached, we certainly will notify investors as to the course we're going to take, to meet our objective of maintaining a publicly traded stock.

As I mentioned at the start of this call, we're focused on the clinical development of 2076, and our goals for 2010 are to support this strategy. We'll continue to conserve cash, we will concentrate on the development, of what we consider to be a very exciting oncology compound. We believe that 2076 represents the Company's strongest asset, and the best driver toward success and improved shareholder value. We're meeting our time lines. We're moving forward with this compound. To date, data have been encouraging, and we have a dedicated, hard working group of employees, committed Board of Directors, and as many of you know, many patient investors. Operator, I would now like to open the line for questions.

Thank you.

(Operator Instructions).

Your first question comes from [William Swanson] with Mayfield Securities.

Yes, hi, thanks for the update. Question I have is it sounds like with the cash burn rate you have, you're ok for about another six months. I'm wondering what you might be looking at in terms of further capital moves, and if there might be -- additional dilution with stock deals, similar to what you did just recently.

Well, William, as I indicated earlier in my remarks, our cash position, that is the position today after the April raise and with the anticipated royalty revenue late this year, from Celgene is we have -- we will have adequate cash to take us through this year, into 2011. Certainly, we will continue to be opportunistic when the opportunity arises, to obtain additional funds at what we consider to be a favorable rate, and minimizing the dilution on our current investors.

At some point soon, will you look more at the urgency of perhaps combining your operations with a larger, better capitalized company to further the mission?

I think companies like ours, and certainly in our case, have to consider all of the alternatives that are available. And we do that, our basic premise has always been what would be the best for advancing 2076, and what would work in the best interest of our shareholders. So, we're constantly in conversation, all kinds of things.

Ok. Well, thank you very much. Good luck.

Thank you. I appreciate your interest.

Your next question comes from [Steven Whitman] with private practice.

Hi, Mr. Tarnow. Good to speak with you. I just have two parts to my question. First has to do with the reverse split. You mentioned a few minutes ago, that EntreMed has certain opportunities to meet the number of the $1.00 closing bid price that NASDAQ requires. Are you at liberty to discuss what those opportunities are, and what we might be able to look forward to in terms of that?

Yes, let me address -- and what's the second part of your question?

The second part is, it sounded like Dr. Sidor said that EntreMed would not be presenting at ASCO this next month. And I thought perhaps had they been presenting, that would have been one of the opportunities to help the stock price reach the NASDAQ requirement of $1.00.

I'll let -- let me answer the first part of the question, and I'll turn the second part over to Carolyn. With regard to the reverse split, it is more than opportunities. We have -- and we, in this case, I'm talking about the Board has several options. The most obvious would be if the stock were to trade in the natural course of events over $1.00 for ten days, we would be fine and there would be no issue. If we don't, then we have to take some action to get the stock over $1.00 to continue to trade on the NASDAQ capital markets. One way in which you can do that is through a reverse split, and as you know, as an investor, having received the proxy, we're asking -- we have an annual meeting early in June. We're asking shareholders for authority to allow the Board to consider a reverse split. No decision has been made.

Number one, on whether or not we would do that, and number two, whether or not, at what ratio we would effect a split. The other options include listing on other exchanges, and all of those -- I mean there aren't a lot. All of those options, two or three, three or four options available, have to, and will be considered at length by our Board in a meeting probably mid to late June. Obviously that's an important event, and we'll notify the shareholders properly when the decision is reached. Now, let me turn the -- the second part of your question, which is an important one over to Carolyn, and that involves when we are presenting data, and why we've chosen to present data in the time frame and the forms we have. Carolyn?

Yes, you are correct. There won't be a formal presentation on ENMD-2076 at the ASCO meeting this year. However, that doesn't mean we won't be talking about the molecule at the meeting, with appropriate groups. And so there will certainly be discussions about the data and the status of the program with investors and companies, as is appropriate. The reason that we are not presenting in front of a poster, an oral presentation this year, is relative to the timing of the meeting. We felt it was very important to get the ovarian cancer data in the public domain, so that we could recruit investigators, and initiate our Phase 2 program promptly. In waiting to release that data to the ASCO time frame didn't fit very well this year. But we remain very supportive of the ASCO meeting. We, as you know, have been there and have been I think extremely fortunate to have most of our presentations accepted for posters or oral presentations during that meeting, and we certainly will be in attendance.

And I should indicate, Carolyn did indicate in terms of our expectations over the next month or two, that we expect, by the time of ASCO, second week in June, I think, that all six sites in our Phase 2 trial will be -- will have initiated. We will be submitting for publication within the next several weeks the data from our Phase 1 solid tumor study, and we're hopeful for publication of that over the next couple of months. So, that's -- both of those are near term news flow items. Thank you.

Thank you very much.

Your next question comes from [James Mooney] with private investor.

Hi, good morning.

Good morning.

Just -- I've been an investor for a number of years. I wanted to congratulate you guys on your mission, which I think is very fulfilling, for a lot of people. And hopefully it will be rewarding to investors. Just a couple of things that I had quick question. One is regarding the royalties from THALOMID. Is that -- do you have any idea, or is that supposed to be something fairly substantial, and you mentioned fourth quarter that you project that? Or is it too early to --

Well, let me indicate what the timing is. The timing is always late in the year. The THALOMID royalties are based upon -- they're paid to us by Celgene. They're based upon two things, that is the total sales of the product, and the markets in which those sales occur. That information will be available to us late in the year, and the royalties will be calculated at that time. And usually what we see is a payment in the fourth quarter, and an ability to book an end of the year payment which generally comes in by February. Celgene is pretty consistent on that. But those things don't occur until we see virtually the full year sales of the product. And that's what we expect to occur this year. It's virtually impossible to -- and it would speculation for us to provide an accurate estimate at this time, since Celgene does not release information about the markets in which their sales occur, and the actual sales of the product.

Follow-up to one of the gentleman that asked a question earlier, my concern is -- and I'm sure many shareholders are, too, I think you're doing a great job of containing costs. But my concern is the -- after reading the 10-K, the Phase 3 estimated completion time is two to four years. So, the question is, as far as the money goes, as far as maybe a partner, a buyout, something to keep EntreMed going, because eventually, if enough money isn't raised, it just doesn't look like you guys will be able to complete your mission. I think that's my concern as a shareholder, and I'm sure many others. I know you said that you're in talks. But I'm just curious if you've approached some of the bigger drug companies, or have they approached you? Or has there been any discussions because -- I would like to see you guys complete your mission.

Let me put what I said in context, and acknowledge your remarks and your concern as being real, and one that the Board concerns itself with. Yes, we have approached companies, yes, companies have approached us. We have concluded that the best -- the likely best course is to obtain Phase 2 data, and that would be the likely -- the time to maximize the shareholder value in 2076. That doesn't mean that we exclude the possibility of doing something before then, if something appropriate that retains upside for our investors in the 2076 program presents itself. So, we will continue to be aggressive about conversations, Carolyn will be at ASCO. And we'll have, I'm certain, a very busy dance card, in terms of conversations with companies there.

A week doesn't go by, where we don't make calls or people talk to us, people who we've already talked to and want to be kept up to date about what's going on, not only in the completion of the Phase 1 studies, but what's going on with the Phase 2 studies as well. So, your evaluation is correct. It is difficult to see a way that this Company would have the funds to take this product through Phase 3. We've always hoped since our re-prioritization, that we could provide adequate funds to get us to a leverage point when we had data from Phase 2. And we're moving along toward that goal.

Just one more question, and I appreciate your answers.

Sure.

Just something to -- that some shareholders have voiced their concerns from -- of what I've heard, is maybe I'm wrong here, but I don't think there's been a lot of purchases by specifically Mr. Tarnow, and the other directors. To me, as a long investor, as a show of faith, even if you made a small insider purchase of the shares to show that you -- that you believe in the Company and you would be willing to put your money where your mouth is, literally. As a show of faith, I think it would be a very good sign to -- long-suffering shareholders. It is just an idea.

No, no. It is -- and let me indicate that each of our Directors owns shares in the Company, that I own shares, and have purchased shares in the Company. My children own shares in the Company. My sister owns shares in the Company. So, there is an equity position on the part of every one of the Directors, including me.

Right. Have you made purchases recently? Or these have --

Not in the last few months.

Oh, ok. But -- just as a step up to the plate and show more confidence.

Thank you.

I mean, the shares have cheap enough as it is, so you wouldn't have to -- you wouldn't be looking at a big money investment, but just as a show of faith.

Okay. Thank you for the comment.

Ok, thank you. Have a good day. Thanks for your help, too.

Okay, next.

Your next question comes from [Peter Logman] with Wellington Shield.

Yes, along the same lines, do you think that you'll be -- can you say in early 2011, you think you can achieve Phase 3 status, and without having raised additional money?

Well, what I can say is that early 2011, we'll have data from Phase 2. I don't think we can -- it would be irresponsible to start a Phase 3 trial without knowing that you had adequate funds to move forward. So, I think what we anticipate is, we will have the Phase 2 data as we get to the Phase 2 data, we'll look for ways to -- and we won't wait until the last day, Peter. We'll look for ways to have money, or a partnership available that will allow us to execute on Phase 3. We won't wait until the last day.

But that data should be definitive, about if we actually will get to Phase 3.

I'm going to look at Carolyn.

I'm not exactly sure that I understand your question. I mean I think that we all feel very confident that 2076 is a compound, a drug candidate that can be developed, and we'll get to Phase 3. If that was your question.

Yes. And also in a time that the data will be convincing enough that you can then raise money, and not such a dilutive level.

We certainly hope that. I fully agree with you on. The other thing, of course, we would like to do, is we would like to be in a position to expand the Phase 2 studies, to include other oncology indications. We chose ovarian as our lead, and as our first, but we have positive data in other indications as well. And would like to pursue that. But much of that depends on financial position. We made a decision to focus our resources, and move things forward as far along in the development scenario as we could, with the funds that we would reasonably have available. And that's what we've done to date.

All right. Thank you very much.

Thank you, Peter.

Mike, could you -- comment on the position of Celgene as your largest stockholder, and obviously an interested stockholder in this whole process?

Yes, well, Celgene has been a shareholder since 2002. For people who have followed the Company, they are the largest shareholder in the Company. They do not have contractual rights to our products to 2076, but they retain a major equity position. They have had -- they have had observer status on our Board and over the years, the head of research, President of the research division, and now is an observer on our Board. And on a regular basis, we keep them apprised of what we're doing, for example, our preclinical study results were reviewed with them, as were the Phase 1 results. As we prepared to enter Phase 2, Carolyn discussed with them her -- the design of the clinical program for Phase 2. They were helpful, in terms of their comments based upon their experience. And they continue -- we continue to have that kind of interaction at a very senior level with their observer on our Board. So, there has continued to be, that kind of help and assistance from them.

Michael, thanks very much. And all the very best.

Thank you, Peter. I know that, when I indicated before that we've had a lot of patient investors, I know from personal experience you certainly fall in that category. Thank you.

(Operator Instructions).

Your next question comes from [Salvatore Marasa] with New Media Capital Group.

Hi, good morning. Good morning, guys, ladies and gentlemen, my question was regarding the NASDAQ compliance. It seems to me, back in I believe October, it did trade for ten consecutive days, and closed over a $1.00.

The -- we believed that too, when we first saw it -- that -- it did trade for ten days over a $1.00. But the NASDAQ rules go not only to the trade, but go to the last bid price. So, for nine days, we were over. On the tenth day, the last bid price was I think, $0.97 or $0.98, and did not meet the specificity of the rule, the specifics of the NASDAQ rule. And we can assure you --

I believe it was --

We did -- (multiple speakers) notification from NASDAQ to say, no, we traded over for ten days. And then they showed us the rule, then we went back, and asked for an exemption from that rule. So, it is only after we could not convince them exactly what you said, that we did trade for over ten days, that we found ourselves in a position we're now in.

Okay. One of the last questions, as an alternative to a reverse split, you try to list your shares on the American Stock Exchange which would still give you the same potential for brokers to buy your stock. Once you go to the bulletin board, it is over, and if you reverse split your stock, it is over. So, as an alternative, I believe --

Yes.

And American Stock Exchange -- it may be a good fit for you.

I appreciate that comment. That is on our list of one of the things to consider, one of the things we have to do in looking at AMEX, looking at NASDAQ, looking at the bulletin board. You've got to look at the listing requirements as well, and we're in the process of doing that and that's part of what the Board will evaluate. So, I appreciate that. We have heard that comment from other investors as well. I can assure you that high on Cynthia's list of things to prepare for the Board.

Ok. Thank you. Thank you very much.

Thank you.

Your next question comes from [Woodrow Gabor], private investor.

Yes. My question is July 16th is rapidly approaching. And Carolyn mentioned the possible -- there's not going to be any release of data, obviously at ASCO. But she mentioned over the next couple of months, there might be or will be some release of data with regard to the Phase 1 trials on-going. Could she be specific as to which trials, and when?

Sure. So, we are preparing for publication in a peer review journal, the Phase 1 solid tumor data. Unfortunately, when you submit to journals, you don't control the timing of the editorial process, and the actual acceptance of that paper into the journal. So, predicting when it will actually be in the public domain, is really very difficult. We will -- aggressively try to get it into a journal as soon as possible, but there is a limitation into our control over that. As far as the other studies are concerned, the leukemia and myeloma study, clearly the appropriate format for presenting data on those two studies would be at the end of the year meeting at the American Society of Hematology. So, the abstracts would be due in the summer, and would fit with the timing of the development of the clinical data. We certainly cannot predict whether those abstracts would be accepted for poster presentation at this time. But that seems to be an appropriate format for discussing those two trials.

Ok. Fine. So, with regard to the Phase 1 data on solid tumors, that's the only significant event that we can look forward to, sometime -- let's say in the next quarter or so.

Well, I think the initiation of the Phase 2 trial that we've announced two sites, four more sites to come on within the next several weeks. We consider that to be a major step forward in the trial because, of course, we need to get people on drug, and we need six months data to start reporting to accumulate the data from the trial. So the sooner we get up and running with the sites, and the sooner we get patients on drug, and so the sooner that time line will run. So, that's an important point in this evolution as well, and as Carolyn indicated earlier, we expect all of the sites to be initiated within the next several weeks, and then patients will start coming on drug on each of those.

Ok. Thanks very much. And good luck.

Thank you.

(Operator Instructions).

Your next question comes from Steven Whitman from private practice.

Hi, Mr. Tarnow, I'm back again.

Yes.

I was confused about the comment about the opportunities that are available to meet the $1.00 closing bid price for the NASDAQ. I understood it that there were certain events that were going to occur, either with the trials or with information, or with something that would raise the stock price. I think though, when I spoke to you, you were implying the opportunities are not for events to occur, but for opportunities to put EntreMed in a different position, so that it doesn't lose its trading status.

That's accurate. Your last conclusion is accurate. Carolyn has indicated what events we expect -- Carolyn and I both indicated what events we expect to happen over the next month, month and a half. I can't predict what that does with the stock price. I think our Board has to consider, not only what is going on from our Company perspective, but what steps we might have to take to make certain that there's a $1.00 stock price to keep the NASDAQ listing, or to arrange for a listing elsewhere, the comment made earlier by one investor about the possibility of AMEX,, possibility of a bulletin board, possibility of a reverse split. All of those are options that we have to consider. So, your conclusion is correct.

I understand. And I've been an investor for many, many years. And it is frustrating for me, as well as others, although your announce -- you're announcing progress going forward and it is wonderful progress. And the four more trial sites that are coming are great. But we all know that the announcement of the first two trial sites, had the stock price go down rather than up. Now, I mean if it were up to me, it would be $10 by now. But apparently it isn't up to me. So, I was wondering what do you see down the road, which would give us some feeling that EntreMed's stock price will be what it is really worth? I don't think it is worth $0.62.

On that, I would agree with you. I don't want to -- it would be inappropriate for me to speculate on stock price. But ultimately, for companies like this, what drives the success of the Company and shareholder value stock price is positive data, is moving your trials forward. Obviously we would have hoped that on certain news we had, things would have moved or moved faster or farther, but that control we clearly don't have. But we have control over is, is to make certain we run a professional trial in absolutely first class cancer centers with investigators themselves, are strong physicians, scientists, clinicians, all of that, we have done. And Carolyn has designed, what we consider to be a very good trial to allow the compound to prove itself.

And that's what we're doing. And our hope is, that when the market sees data, they'll recognize it, and recognize it as positive, and to date it has been. The data from Phase 1 is very encouraging. The investors who have come in over the last year, I mean there is substantial trading that continues to go on in the stock. We're encouraged by that. We're encouraged by people like you who have been more than patient. But the reality is, the ultimate reward will come when we see data, and that data has to be positive for that reward, and we're trying -- we're doing everything we can to maximize the opportunity that the drug will show itself and show itself well.

I have every confidence that you are. Thank you very much for your comments.

Thank you. I appreciate it.

Your next question comes from William Swanson with Mayfield Securities.

Yes, just as a follow-up, some of the comments you've made, given your unwillingness to accept merger terms as presumably discussed, and given your cash position, is it fair to conclude that the future of this Company is completely dependent on the next 2076 trial results?

No.

No?

I think your conclusion that we're unwilling to discuss merger terms --

I didn't say that. I said that given your unwillingness to accept merger terms.

Well, there is an assumption there, that there are merger terms that would provide value for our shareholders. If those occur, and they can occur any time -- I mean I remind people around here that major -- million dollar companies manage to do mergers over a weekend. If that were to occur -- the only thing I can assure you is that we're open to every opportunity to create shareholder value. What we aren't open to do, is to close out any possibility of our shareholders, enjoying the success or some of the upside of what you've invested in for a long period of time. And that's our guiding principle. There is no ego involved. There is no desire that we control something.

The desire -- we believe that 2076, is a solid product opportunity for this Company or for a new Company. But for there to be a new Company, the new Company would have to provide adequate funds to expand the 2076 clinical evaluation, to do what we are not financially able to do. And to number two, retain significant upside for the investors who have brought the product to this point, and have invested in EntreMed. Those are the only things we ask for in discussions. And it is accurate to say, that we continue to be open to, and have discussions with people about the possibility -- all possibilities to move this Company forward in it's current configuration or other configurations.

At the same time, you really have two challenges. One obviously is to get the kind of results you want on 2076. And he other frankly is time.

Yes. That's totally accurate. And we certainly are aware of that which is why we are very active in everything we do. There isn't a week, there isn't a day, where several of us aren't talking about what do we do next, and how do we move the Company forward.

Ok. Well, thank you very much.

Sir, your comments are -- your comments are accurate in terms of our concerns, and those are our concerns, and we're trying to address them.

Well, good luck.

All right. Thank you. I'll take one -- operator, if there is one last question?

There are no further questions. I would now like to turn the call back over to Mr. Tarnow for closing remarks.

All right, thank you, Carrie. I appreciate it. And I appreciate the opportunity to talk to, and respond to our investors this morning. It is our obligation, and our desire to keep you informed about what we're doing. To not only respond to your comments, but to incorporate your ideas into what we're doing. No one has -- we certainly don't have a monopoly on good ideas, and we appreciate your help and suggestions. All of us, I know, several of us answer investor calls on a regular basis. I continue to remain optimistic, but I do know that there are hurdles for companies like EntreMed, and EntreMed itself. The only thing I can assure you is,is that there are 13 people in this Company who work every day, for the benefit of the shareholders, and to move our product, and our product opportunities -- and our product opportunities forward. Thank you very much.

Thank you. This concludes today's teleconference. Please disconnect your lines at this time, and have a wonderful day.