CASI Pharmaceuticals Inc (CASI) 2008 Q2 法說會逐字稿

Good morning and welcome to EntreMed's company update call. At this time all participants have been placed in listen-only mode. There will be a question and answer session prior to the conclusion of the call.

It is now my pleasure to turn the call over to your host, Mr. James S. Burns, EntreMed's president and CEO. Mr. Burns, you may begin.

Thank you and good morning everyone. Welcome to our second quarter 2008 update conference call. Joining me on the call this morning is Mr. Dane Saglio, our chief financial officer, Dr. Kenneth Bair, our senior vice president, research and development and Dr. Carolyn Sidor, our vice president and chief medical officer. Also joining us for the first time on the call today is Mr. Thomas Bliss, recently appointed senior vice president of corporate and business development.

Before I begin, I'd like to caution that comments made during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operation and future results of EntreMed. I encourage you to review the company's filings with the Securities and Exchange Commission including the company's forms 10K and 10Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

The content of this conference call today contains time sensitive information that is accurate only as to the date of the live broadcast, August 12, 2008. EntreMed undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call.

I will begin today's update by saying that our entire management team remains confident in the company's prospects and in our capabilities. The company is in a sound position financially. We have a focused pipeline of promising drug candidates and we have the team to move these programs forward even in the face of continuing downward pressure on our stock price.

Market conditions during the first six months of 2008 have been volatile and are likely to continue to remain volatile for the remainder of this year.

Consistent with our strategy, we've reviewed the potential for the programs in our pipeline with the objective of selecting the most promising product candidates to pursue while keeping in mind the need to ride out the current market volatility. Our plan for the duration of 2008 is both consistent with these objectives and as I believe will keep us on a positive track toward creating shareholder value.

During the call I will review our program plans and milestones for the remainder of 2008.

As a clinical stage pharmaceutical company developing novel, multimechanism drugs for the treatment of cancer and inflammatory diseases, our goal has been to develop and commercialize orally administered, small molecule drugs that have both antiproliferative and antiangiogenic activities. We currently have four product candidates in clinical development that are based on these mechanisms.

Our goal with these four product candidates has been to rigorously test and evaluate them both as single agents and combined with other approved drugs in order to build sufficient early clinical data with which to make larger and more selective investments in specific programs.

In rebuilding our pipeline over the past several years, we have moved four oncology programs into phase I and phase II trials and we have initiated clinical development for our 2ME2 program in rheumatoid arthritis. We have built our pipeline through a combination of internal development and acquisition to provide the opportunity for us to refine our internal focus and seek pharmaceutical partners to develop programs that would take greater resources to develop than we have currently.

Our prioritization remains on our three oncology programs, MKC-1, ENMD-2076 and ENMD-1198. These programs we have seen potent antitumor activity in multiple preclinical models, single agent activity that can induce significant tumor inhibition and antiproliferative and antiangiogenic mechanisms.

As discussed during our March 2008 update, we have focused our efforts on a smaller number of programs, essentially of greater concentration of resources behind a fewer number of promising opportunities. This is not only prudent from a strategic perspective, but current market uncertainties limit the near-term financing opportunities available to microcap companies.

We remain focused on the following objectives, namely concentrating our resources on fewer programs that provide a more direct path forward to product registration and ultimately to the market, conserve cash by funding essential priority program activities and deferring new program initiatives and three, expanding our partnering activities across our clinical programs.

With respect to our business development objectives, we are pleased to have Tom Bliss join the company to lead our corporate and business development activities. Tom brings nearly 20 years of biotech business development and healthcare investment banking experience to us, most recently as executive director for licensing at Amgen. We are confident that Tom's extensive knowledge and experience will better position us to execute on our partnership objectives.

We have expanded our efforts in seeking corporate partner opportunities for our programs, particularly ENMD-2076 for oncology and Panzem for rheumatoid arthritis. We announced this morning the engagement of JSB-Partners, a global life sciences advisor, to provide greater bandwidth for our partnering efforts and to provide the global reach for international partners. JSB-Partners are stationed in the US, Europe and Japan.

To support our partnering activities, we currently have four worldwide commercial rights to all of our pipeline programs, strong intellectual property protection including composition of matter for all of our compounds, which are also backed by solid preclinical data packages that provide an informed direction for our clinical development efforts.

We expect to remain on track with our previous guidance for partnering efforts for 2076.

Our focus in oncology enables us to direct resources toward our highest potential clinical oncology programs-MKC-1, ENMD-2076 and ENMD-1198. All three compounds have shown good single agent activity, are druggable, demonstrate significant antitumor activity in multiple preclinical models and have strong intellectual property positions.

ENMD-2076 and 1198 provide candidate -- product candidates were discovered internally while we have an exclusive worldwide license from Roche for MKC-1. Our Roche license does not include any [drawbacks] or obligations other than success milestones and royalties.

I would now like to review the pipeline of oncology product candidates that we intend to focus on in 2008 and bring you up to date on our progress with these programs. I'll start off first with MKC-1. MKC-1 is a novel, orally active, cell cycle inhibitor with in vitro and in vivo efficacy against a broad range of human solid tumor cell lines including multidrug resistant cell lines.

Data from previous studies with MKC-1 demonstrates tumor growth inhibition or regression in multiple preclinical models including paclitaxel resistant models.

MKC-1 has been shown to inhibit cell division and induce apoptosis or program cell death. Furthermore MKC-1 inhibits the Akt mTOR signaling pathway, which we believe occurs through inhibition of the mTOR rictor complex. The PI 3/Akt/mTOR pathway is the most frequently mutated pathway in human tumors and deregulation of the pathway promotes tumor progression and decreased survival in cancer patients.

Specifically, mTOR controls cell proliferation, angiogenesis and metabolism. mTOR exists in two distinct complexes, the TORC1 complex, which contains the protein raptor, and the TORC2 complex, which contains the protein rictor. Rapamycin and a number of closely related analogs such as TOR cell and RAD001 are first generation mTOR inhibitors that target the TORC1 complex. Several of these have already been approved for the treatment of cancer.

MKC-1 represents a novel TORC2 mTOR inhibitor that acts upstream in the PI 3/Akt/mTOR pathway and directly inhibits the phosphorylation of Akt, thereby blocking the activity of downstream signaling including the TORC2 raptor complex.

Our scientists have shown that TORC2's mechanism in addition to the interaction with important beta and microtubule disruption confer a unique multimechanism role for MKC-1 in cancer therapy. We now have what we believe is a second generation mTOR inhibitor that has broad single agent activity in its own right.

Furthermore, we believe that MKC-1 is the only TORC2 mTOR inhibitor currently in clinical trials.

At the time we licensed MKC-1 from Roche, its mechanism had not been fully understood. However, the compound showed strong tumor growth inhibition or regression in multiple animal models. Roche's early clinical experience also showed objective responses in metastatic breast cancer and non-small cell lung cancer patients, studies which we extended as part of our commitment under the license.

Since then we have expanded MKC-1's preclinical database to identify cancer indications and combination approaches that reflect our more comprehensive understanding of MKC-1's mechanisms.

We have also extended our clinical experience with MKC-1 at beyond the early breast and lung cancer trials initiated by Roche and into hematological cancers and we are exploring alternate dosing schedules based on our preclinical findings. A continuous dosing paradigm is consistent with our preclinical data and with dosing schedules of the first generation rapalogs.

We have also added new indications such as the ovarian endometrial trial, which is supported by information of the compound's mTOR mechanism of action.

In connection with our license with Roche, we have also purchased sufficient drug substance to conduct our clinical trials for the foreseeable future, a situation that precludes our need for substantial near-term manufacturing and process development costs.

We currently have six clinical trials underway with MKC-1 including single agent and combination studies with approved chemotherapeutics in various cancer indications.

We have commenced multiple phase II studies in indications where activity has been seen in earlier studies and a phase I study in leukemia. Based on preclinical data and mechanism studies, we have also initiated a phase I continuous dosing study in solid tumors. We believe that a continuous dosing schedule has the potential to improve tolerability and enhance MKC-1 activity in cancer patients, similar to increased antitumor activity that sustained exposure has demonstrated in preclinical studies.

Through the phase I study we expect to determine not only the maximum tolerated dose of MKC-1 when administered orally twice a day on a continuous basis, but the pharmacodynamic changes using imaging techniques as proof of drug effect and assessment of toxicity.

MKC-1 is also in a phase II clinical trial in pancreatic cancer and a multicenter phase II study in ovarian endometrial cancers.

In June EntreMed collaborators presented data for the MKC-1 phase II single agent open label study in metastatic breast cancer during the American Society of Clinical Oncology annual meeting. A total of 55 patients who had previously received at least one anthracycline and taxane therapy were evaluable for tumor response. Of the evaluable patients, the antitumor activity observed with MKC-1 included three patients who had objective responses and five patients with stable disease lasting more than four months. These data were consistent with prior Roche breast cancer experience.

Going forward, we believe that further work will enable us to define why some breast cancer patients responded to MKC-1 treatment and other patients did not respond. By combining our current data with new mechanistic insights that have revealed mTOR and HIP1 as molecular targets of MKC-1, we will be in a better position to design future clinical studies and define less refractory patient subsets that we believe will benefit from MKC-1 treatment.

Additionally, based on data from several preclinical models, we believe that by administering MKC-1 on a continuous dosing schedule, we should be able to enhance the compound's antitumor activity.

While we may initiate several additional trials in late 2008 or early 2009 based on the results of ongoing phase I and phase II studies, we believe that our current mix of single agent and combination trials will clarify the potential benefit of MKC-1 and define a path forward for randomized phase II clinical studies.

So for the remaining of 2008, our milestones for MKC-1 involve a combination of reporting results on existing trials and initiated new trials, namely presentation of interim data for MKC-1 in combination with Alimta, presentation of data for phase I study for MKC-1 in hematological cancers and the presentation of interim data for the phase II study in pancreatic cancer.

With that I would like to turn attention to ENMD-2076. ENMD-2076 is a selective kinase inhibitor with a unique kinase profile in multiple mechanisms of action including antiproliferative activity and inhibition of angiogenesis. ENMD-2076 has potent activity against Aurora A and tyrosine kinases linked to promoting cancer and inflammatory disease.

2076 has demonstrated substantial dose-dependent efficacy as a single agent in multiple preclinical models including tumor regression in breast, colon and leukemia models. Importantly, 2076 is an oral agent that has shown an acceptable toxicity profile in preclinical studies without cardiovascular effects.

2076 is a unique-in-class compound that inhibits Aurora A selectively over Aurora B. Aurora A expression is linked to decreased survival in multiple cancers and its inhibition leads to cancer cell apoptosis.

2076 also inhibits a number of other kinases important in the growth of tumors and in particular growth factor receptors critical to angiogenesis.

2076 has shown potent antitumor activity in multiple preclinical models, both solid tumors and hematological cancers.

Based on our preclinical studies we believe that inhibition of the three kinase classes produces enhanced tumor effects with a tolerable side effect profile and no apparent cancer cell resistance.

During the second quarter we initiated a multicenter phase I clinical study in patients with advanced cancers. The 2076 study being conducted at the University of Colorado and the Dana Farber Cancer Institute is an open label, three-plus-three dose escalation design with a projected enrollment of up to 30 patients. The study is designed to assess safety, PK and clinical benefit endpoints in solid tumor patients. Soluble VEGF receptor 2 will also be measured as part of the study's pharmacodynamic evaluation.

Subsequent studies are being planned for multiple myeloma and hematological cancers.

We expect that the 2076 program will move quickly through the phase I trial providing us with a phase II dose and sufficient data to design and initiate one or more phase II trials in 2009.

In addition to the clinical program, our goal for 2076 is to accelerate development of this promising program with a larger development partner. We are conducting a directed global partnering effort now that ENMD-2076 is in human clinical trials.

In addition to our lead compound, we have in vivo activity data on a dozen other Aurora kinase inhibitors and pending patents on over 600 analogs of ENMD-2076.

So remaining milestones for 2076 in 2008 include initiating a phase I trial in multiple myeloma or hematological tumors before the end of the year and continuing to exploit the opportunities for a codevelopment alliance.

With respect to ENMD-1198, this is a potent, orally active antimitotic agent that causes cell cycle arrest and apoptosis in tumor cells. This is a new chemical entity discovered at EntreMed with a strong intellectual property position. 1198 has shown positive antitumor activity in multiple preclinical animal models.

Preclinical data has demonstrated that oral administration of 1198 leads to pronounced in vivo antitumor activity in cancer models, specifically reductions in tumor burden and increases in survival when compared to controls.

A phase I dose escalation clinical trial is currently underway to evaluate 1198 in patients with refractory solid tumors. The phase I study has proceeded through multiple cohorts so far without any drug related toxicity at doses that are approaching the maximum tolerated dose observed in our preclinical models.

We expect to complete enrollment for this study in the fourth quarter of this year, determine a phase II dose and then proceed forward with either extended phase I or phase II clinical trials. However, as we continue to focus on the development of MKC-1 and 2076, and market conditions remain uncertain, we may place the clinical development of 1198 on hold until we partner ENMD-2076.

But with respect to 2008 milestones for 1198, our goal is to complete the phase Ib enrollment, initiate an expanded phase I or phase II trial in 2008 unless we put the program on hold, and report the data out from our phase Ib trial.

Now with respect to 2ME2 in rheumatoid arthritis, as we announced in our March 2000 update, our investment in the 2ME2 program has been directed to a non-oncology application, rheumatoid arthritis based on our preclinical research results and the knowledge gained during our oncology development program for 2ME2.

We are pursuing the evaluation of 2ME2 for rheumatoid arthritis due to its favorable safety profile as well as its antiangiogenic and anti-inflammatory properties. Results from multiple preclinical studies demonstrated that 2ME2 has disease-modifying or DMARD activity. These preclinical studies have shown consistent inhibitory effects on the hallmarks of the disease including the inhibition of the highly angiogenic pannus tissue, infiltrating cells, cartilage lesions and bone resorption.

We have also seen an additive effect when 2ME2 is combined with methotrexate, a current standard of care treatment for rheumatoid arthritis.

We believe that Panzem for RA represents a safe, orally administered, small molecule alternative to current biologicals that can contribute to the treatment paradigm for patients with RA. Rheumatoid arthritis affects over 2 million American adults alone, of which about two-thirds of them are women. Unmet need still exists in this market, particularly for safe, orally administered products.

Based on 2ME2's demonstrated safety profile and activity in oncology patients, its mechanisms of action and its activity in preclinical RA models, we believe that Panzem represents a first-in-class opportunity in a large, multi-billion dollar global market.

2ME2's multiple mechanisms are unique in the treatment of RA, essentially an oral DMARD with antiangiogenic activity. Furthermore, 2ME2 has shown an impressive safety profile in over 300 cancer patients, some have whom been treated with 2ME2 for over five years.

Clinical activities to support 2ME2 in RA have been initiated starting with a clinical study in healthy volunteers as opposed to RA patients. We have now completed the healthy volunteer study and submitted the results, the study results of the FDA, for the FDA's requirement for a safety study before commencing studies in RA patients.

Once the FDA has reviewed the results, we should be able to determine the appropriate next steps for the program. With healthy volunteer data and FDA feedback, we expect to launch our partnering efforts for the RA program in the fourth quarter of this year.

I would now like to turn to provide a brief overview of our current financial position. On August 6, 2008 we filed our report containing financial results for the six months ending June 30, 2008 on form 10K.

Net loss for the second quarter 2008 was $9.6 million or $0.11 per share as compared to $7.9 million or $0.10 per share in 2007. Net loss for the quarter includes a non-cash charge of $2 million which represents a purchase price adjustment milestone triggered by the dosing of the first patient in a clinical trial for ENMD-2076, the lead molecule in our Aurora kinase program, which was acquired from Miikana Therapeutics in January 2006.

As of June 30, 2008 the company had cash and short-term investments of approximately $36 million. The company has cash and short-term investments to support current and planned activities well into the second half of 2009. We believe we will also record royalty revenues in excess of $7 million in sales of Thalomid by Celgene in the third and fourth quarters of 2008.

Furthermore, we anticipate that cash used in operations in 2008 will be under $24 million and in 2009 we expect our R&D expenditures to be lower as a result of focusing on our priority oncology programs and a positive impact from our partnering efforts.

As I mentioned earlier, we are pursuing a course of action in 2008 consistent with the strategy we embarked upon several years ago. By building a portfolio of multiple clinical candidates in oncology, we expect to enhance our opportunity to succeed with one or more of our product candidates while at the same time mitigating the inherent risks associated with oncology drug development.

Our goals for 2008 continue to support this strategy, invest selectively, conserve cash and monetize one or more of our pipeline assets. The specific elements of our 2008 plan involve concentrating our resources on fewer programs that provide a more direct path forward to product registration and ultimately to the market, conserving cash by funding essential priority program activities and deferring new program initiatives, and expanding our partnering activities across our clinical programs.

I continue to believe that multiple shots on goal is the appropriate business model to follow in building a viable drug development business and ultimately creating sustainable shareholder value. In 2008 we have three viable oncology programs to pursue, MKC-1 in multiple phase I and II trials, ENMD-1198, which we expect to complete its phase I clinical trial before year end, and ENMD-2076, which is moving rapidly through a phase Ib study in advanced cancer patients.

Furthermore, our prior investment in Panzem in oncology has provided the foundation to cross over into potentially larger market opportunity in rheumatoid arthritis. Completion of our healthy volunteer study should place us in a good position to partner with a major RA pharmaceutical company for phase II and phase III clinical development.

We fully recognize the realities of this business. Drug development is expensive and we need to offset our share costs with pharmaceutical partners in order to advance a portion of our programs into later stages of development. By partnering one or several programs in our pipeline, we will be able to fund the company with lesser, non-diluted financing, free up cash for internal programs and validate the technology that we have been developing over the past three years.

I am confident in our ability to partner because we have full worldwide commercial rights to all of our product candidates. We've got a strong intellectual property position and the compounds are backed by solid data packages. We also have the flexibility at this point to pursue partners for multiple programs and lead programs for our own account. Now is the time for us to focus increased attention on partnering.

The realities of current market conditions also means that we must conserve our cash resources and invest them judiciously behind those programs where we believe based on the best available data at hand there is the most promise. We have developed a solid culture of prudent cash management throughout the company that I believe will help see us through these turbulent times.

Market conditions during the first half of 2008 have created downward pressure on our stock price and we are planning as though the volatility will continue into 2009. This has been a very difficult time for small cap companies, particularly for microcap biotechnology companies. I believe that the recent downward pressure on our stock price is a function of the market place weakness rather than any issue which is fundamental to EntreMed specifically. Our market cap has declined in line with other comparable microcap oncology development companies.

As we announced in April, the company received a deficiency notice from the listing qualifications department of the NASDAQ stock market advising that the bid price on the company's stock had closed below the $1.00 minimum per share requirement for continued inclusion on the NASDAQ global market. While the company has until October 1, 2008 to comply with this minimum bid requirement to remain eligible for quotation on the global market, we would be eligible for capital market listing so long as the company meets the listing requirements of the NASDAQ capital market.

In the event our stock price continues to trade under $1.00, we will consider other alternatives to maintain eligibility including applying directly for the capital market listing. However at this stage we are focusing on partnering and pipeline progress to move EntreMed into the next stage of development. Our announcement today of the JSB-Partners engagement is designed to enhance our prospect for partnering our Aurora A angiogenesis inhibitor.

We are committed to moving ahead on our priority programs while conserving our cash resources. Our investments in 2008 are concentrated on the priority programs, which means new initiatives will be deferred for the time being. We have built EntreMed's recent pipeline through a combination of internal development and company acquisitions. We have developed a pipeline of oral, targeted therapies that inhibit validated kinases and other important targets.

MKC-1 and ENMD-2076 are both unique-in-class compounds and 2ME2 is a first-in-class RA compound. We will continue to exploit these opportunities both on our own and with partners. We will also continue to selectively seek acquisition opportunities such as individual products or companies that could favorably impact the quality of our pipeline, allow us to de-risk the company and enhance shareholder value.

We intend to stay on course, invest behind our promising programs, execute to plan, manage our cash conservatively and continue to work to create shareholder value.

We have the resources to move our products or programs forward well into 2009. Our development pipeline has a sharp focus and we are devoting substantial attention to partnering. Our board and management team remain committed to our business strategy and we are confident that our product pipeline will show results in 2008 and beyond.

I would like to thank all of the shareholders for your continued support and encouragement as we work to build EntreMed into a leading oncology company.

Operator, we will now open the line for any questions.

Thank you. The call will now be opened for questions. (OPERATOR INSTRUCTIONS) One moment while we poll for questions.

Our first question is coming from Ren Benjamin with Rodman. Please go ahead.

Hi, good morning and thanks for taking the question.

Good morning Ren.

I guess just going to the pipeline, can we get an update as to what's happening with each of the trials? So you reported some good data at ASCO regarding the metastatic breast cancer trials, MKC-1. What's happening with that trial now? Are you following the patients longer? Has it been shut down? When might we see updated data? And then stuff like that, go down the remaining trials as well.

As usual, Ren, I'll turn that question over to Carolyn.

Good morning. I can certainly address the top line studies. I think it probably goes beyond the call to do a whole roll call of our entire pipeline, a dozen or so trials.

The breast cancer study closed to enrollment and the final data were presented at ASCO, however you're right to point out we continue to treat patients on that study until they reach one of the predetermined endpoints. The next update you'll see on that will be a publication. At this point there's no intent on our part or the investigator's part to do another presentation at a meeting. And that will provide the updated information on all the remaining patients.

As far as other studies where we are looking in phase II, MKC-1 as you know is in a combination study in non-small cell lung cancer with Alimta. That study is reaching its end of its first stage and there will be a determination by the investigators as to the merits of the data to pursue into the second stage. If it turns out to be positive or negative, we will find some way to get that information out to you. But that should happen shortly.

So, I'm sorry to interrupt. That should be a third quarter event?

Absolutely.

Okay.

The other phase II study is in second line pancreatic. Again, that study is designed to go up to 30 [some] patients. We always do a look at data since these are all open label studies with the investigator somewhere at the halfway mark to make sure that we are still on track to meet our primary endpoint. I intend to do that sometime this fall and we will make those results available to you as well.

The other studies are really phase I in hematological cancers. We are targeting information on that study for ASH this year. Obviously abstracts haven't been submitted yet so we can't say for sure whether ours will be accepted but that's our goal.

The other phase I study is too soon to really speculate on the data for that, which is going on at the University of Wisconsin.

The ovarian endometrial study is ongoing in Canada, two parallel groups of patients, clearly the ovarian patient population enrolled more quickly than the endometrial and sometime this third quarter we'll be looking at the data for the ovarian arm, although I think it'll be certainly fourth quarter into next year before we look at the data from the first stage of the endometrial arm. And again we'll find a way to make that known.

So we should hear something from EntreMed regarding the ovarian arm in the third quarter of '08 or you think the fourth quarter?

I think it'll probably be fourth quarter only because we are close to the full enrollment in the first stage of that but we would want patients to be followed long enough so that we can evaluate it properly for the endpoints.

And for the endometrial arm, say the first half of '09.

Yes, I think it's fair, Ren. It's hard to speculate on enrollment in a disease like that because there are so few patients to draw from but we're doing well and I think that's a reasonable goal.

Okay. And that's it for the MKC-1 trials, right?

Right.

And so I guess one question more for a bigger picture point of view is back when the Panzem oncology program was ongoing, one thing that happened was that we went really broad with the exposure of Panzem to a whole slew of different indications and one thing that was not able to get successfully done was a tapering back down of those indications to focus. And I think that was something, Jim, that you mentioned on the call that by 2009 there would be a significant focus on honing in on particular indications.

Right.

Is that -- can I expect and model that, even though we have six trials ongoing with MKC-1 right now, that by 2009 we would be down to more advanced studies but in maybe two, maximum three indications.

That's our goal.

Yes.

Okay. And regarding the partnerships and I guess the Aurora kinase program, clearly there are a lot of Aurora kinase inhibitors out there. Everyone sort of touts their own advantages. You guys are clearly talking with partners and trying to put together your pitch book as well. Can you maybe just sum up for us the advantages that you see for your Aurora kinase inhibitor over others that are in development?

There's been some data out there that shows, call it an unfavorable toxicity profile with some of the more advanced Aurora kinase inhibitors, if I'm remembering that correctly, and Carolyn you can correct me if I'm wrong, and so how does this compare?

And I guess finally, what is the sort of partnering atmosphere right now for Aurora kinase inhibitors?

So Ren, I'll let Tom get on the phone first and then if he needs any backup from either Ken or Carolyn, they'll chime in.

Sure. Well, one of the things that I observed in the last week was that targeted oncology therapeutics came out and interestingly enough it talked about all of the key targeted therapies, one of which was cell cycle inhibition, one of which was antiangiogenesis and the third of which was antiproliferative. And all of those qualities exist in ENMD-2076. And I would defer to Ken to go into its technical merits in greater detail.

With regard to partnership, in addition to focusing that we'll do internally, we would expect to dialogue with our partners as regard to focusing the clinical development of this product candidate and we would look for a partner to ante up both in terms of giving us consideration for the work that's already been done as well as funding a substantial portion of the development going forward so that we could really have a partnership on the molecule in the future.

And I think there are plenty of examples out in the market place that I think are good, indicative examples for us to follow. One for example is the Onyx/Bayer relationship.

I guess before we go to Ken though to talk about the technical merits, I guess what I'm trying to get a sense of is, is there still an interest out there for Aurora kinase inhibitors? At one point there was quite a buzz being created and it seems like that has somewhat died down and I'm just trying to get a better sense of that.

My impression is that there's still a great deal of interest because targeted cancer therapy's just coming into its own. Some of the -- if you get any diminish of interest, if you're picking any of that up, my impression is that's more driven by the number of candidates out there and I think you touched on exactly the reason that we've engaged JSB-Partners to help us with the broadcasting of this effort because to be fair, it is a crowded space.

Right.

So and just Ken can certainly add to this but from a clinical perspective, our compound's oral, which is an advantage right off the bat. Some of the others, Aurora kinase inhibitors that are out there. I think if you just have Aurora as what you're impacting then certainly there's been some up and down about how people feel about those kinds of compounds. But we don't. We have a whole set of kinases that I think are unique.

Our preclinical package was clean in terms of the safety pharmacology. I also think that preclinically if you've been following our posters, we show a number of tumor models where we show regression, not just inhibition of tumor growth.

And those, at least off the top of my head, certainly distinguish us from some of the compounds that were in the clinic or are in the clinic now that claim Aurora activity but Ken can add to that as well.

Yes, if you look at the literature, there's about a dozen compounds that are in clinical trials. The highest of them is in phase IIs. As Carolyn said, four or five of those compounds are IV only and others have poor pharmacologic properties associated with them.

The idea of having a selective Aurora inhibitor as the only activity, again, the jury is out on whether that will be useful, but it definitely suggests that combination of these molecules with other chemotherapeutic agents is a must. The fact that 2076 inhibits growth factor kinases, cell cycle kinases, specifically Aurora A versus Aurora A and/or B, and has potent antiangiogenic activity, we feel positions 2076 into a compound that has a profile that should make it active as a single agent over a broad variety of cancers.

We know this to be borne out in the preclinical trials and we expect that that will be true as we move through our own human clinical trials.

Terrific. Thank you guys very much.

Thank, Ren.

Thank you. Our next question is coming from [Steven Whitman] with Private Investor. Please go ahead.

Thank you, how are you?

Fine, thank you. How are you this morning?

Okay.

Good.

About four months ago, back in April, the company said that there was a proposal for reverse stock split which might be offered for a vote at the June shareholder's meeting. And then 15 days later the company issued a press release saying that a reverse stock split would not be necessary at that time. So my question is what happened between April 7 and April 22 which made the company decide that the reverse stock split would be unnecessary?

Why -- first of all, I'm not sure we said unnecessary but what we had been doing through the time was trying to understand what our various options were for going back into compliance with the NASDAQ requirements for capital -- for global market. And it was not an easy decision to decide to stay the course and not do a reverse split. But reverse split was certainly one of the options available.

We had -- we put that out there as one of the options that we were exploring because we hadn't really come to a full conclusion yet on what we were going to do. But in the end, after reviewing the pros and cons of various options, we elected, at least for the time being, to not do a reverse split.

So what do you feel will be done, if anything needs to be done, in order to reach the goal by October 1 or beyond that, the stock price?

I'm going to turn that part of the question over to Dane Saglio.

(Inaudible) will remain deficient, the option is there to apply for the capital market, which is probably the route that we'll go at that point. But in the meantime, the partnering efforts and would certainly be something that we would hope to create traction with for the share price.

Once we -- if we do find ourselves on the capital market, we have an additional 180 days to reach compliance on this minimum $1.00 bid so we have that additional period to try and create that same type of traction and stay away, if possible, from the reverse. But we will do -- consider all alternatives to remain listed.

All right. So you're hoping that the partnership activities would do what we need to get things where we want them to go to.

That is the shortest salvation to identify right now. I think in the long term the tide will rise and as our programs move forward, like I said, I hope we get traction in the stock price but the short term answer would be we hope to successfully transact.

Okay. Thanks for your answers.

Thank you. (OPERATOR INSTRUCTIONS) Our next question is a followup coming from Ren Benjamin with Rodman. Please go ahead.

Hi, thanks for taking the followup. The ENMD-2076 trial that's ongoing, the phase I, maybe I didn't write it down in my notes, but when is that going to be complete?

I think we've had this conversation a lot. It's a phase I and so the completion will really depend on the number of cohorts we have to go through to reach the maximum tolerated dose. And on average a phase I study in oncology takes about a year to complete. We enrolled our first patient in the second quarter of '08 so the best guess we can tell you right now is sometime early next year.

Okay, great. Thank you.

Sure.

Thank you. If there are no further questions I would like to turn the call back to Mr. Burns for any closing remarks.

Again, thank you all for participating in today's calls and for your continued interest in EntreMed. We will continue to work hard to move our programs forward and as I mentioned we will continue to judiciously apply our cash resources to generating data on our programs and moving the company forward.

And then finally I'd like to just formally welcome Tom Bliss onto the team and he has his work cut out for him this term and we're relying on Tom and the JSB-Partners to help move us forward on the partnering front.

So again, thank you all very much.

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