Oruka Therapeutics Inc (ORKA) 2004 Q1 法說會逐字稿

-- first-quarter 2004 results and 2004 annual shareholders meeting and conference call and webcast. My name is Ted Love and I'm President and Chief Executive Officer of Nuvelo. It is a pleasure today to be here to discuss the success and achievements we've had over the past year and to give you some guidance on our goals for 2004. Dr. Steven Deitcher will be joining me and walking us through the data in our clinical programs. And Pete Garcia will also be joining us to discuss the financials and guidance for 2004.

Before we begin I'd like to refer you to our safe harbor statement. For more details you can refer to our SEC filings, but obviously we will be making forward-looking statements today.

I'd like to start with our mission and just read that very carefully for you. Nuvelo is a biopharmaceutical company focused on the discovery, develop (ph) and commercialization of novel (indiscernible) acute cardiovascular (indiscernible) in cancer. The reason I want to read that is that we know that there's been a history of a company which has been in many areas. We are highly focused on these areas and I think that's been a tremendous part of our success that we have identified our area of focused and it relates to our area of strength. But what have we done over the past year and what are we trying to do this year?

Looking to our 2003 goals, our first goal we call product map (ph), that has three elements to it. The first element was to move our alfimeprase program through Phase II trials and you'll hear today about the progress that we've made there. In addition we were trying to bring in at least one additional clinical candidate, many of you already know we've been quite successful at that and actually have brought in two additional candidates, ARC183 and a 50-50 partnership at Archemix and rNAPc2 that we acquired from Dendreon, and you'll hear more about those today.

The third element was to identify product candidates from our internal research effort and I will very briefly refer those today, but I can tell you we have made great progress in that regard.

The second goal for 2003 was cash to last (ph). There were a number of elements to that, specifically we expected and have been successful at executing, as you know, raising cash through the financial markets. We also completed a merger and physically we did an overnight transaction last fall to the tune of $28 million.

The third goal we titled our focus is therapeutics. The two elements there were to get the Company internally very focused on that goal of therapeutics in terms of people, in terms of priorities; and the second element was to diverse -- divest the noncore assets that did not relate to this business but relate to previous business that our companies have been engaged in.

The final goal for 2003 we titled let's (indiscernible) success together. Many of you probably can't (indiscernible) that but I can assure you that one of the most important issues -- our company is to have a stimulated and motivated employee population. We have that. We've been very successful at implementing a number of programs to re recruit and rejuvenate our employees, I'm very proud of that.

Looking to 2004 what are we trying to do? The first (indiscernible) here we titled advanced (indiscernible) product opportunity. There are a number of elements to that. Number one, we expect to move our alfimeprase program into Phase III in the second half of this year. We expect to begin enrolling very soon, in our Phase IIa trial with rNAPc2. We expect to file an IND with ARC183 in the first half of this year and again our Phase I program of that product in the second half of this year.

And lastly, turning again to research, we expect to advance at least one of our internal research efforts into IND enabling studies (indiscernible) by the end of this year, and we've been protracting very nicely towards doing that.

The second goal for 2004 we titled building upon our strengthening financial position. We plan to execute that and already have made progress (indiscernible) specifically doing financing, continuing to try to monetize our noncore assets and also a number of business development opportunities that we expect to make progress on as the year moves forward.

And finally, in 2004 our last goal is to continue to build a world-class company. Two elements to that include our research efforts -- our research and development efforts which are (indiscernible) again making great progress. And lastly we plan to communicate our story; Nuvelo really is a new company, a very exciting company and we've been putting a lot of energy into getting out and letting people know our story and that's gone extremely well.

As you can see, we've made a number of progress -- made significant progress on our 2004 goals. Now I'd like to walk you through some of those one by one. In terms of recent accomplishments are goals have been to build a cardiovascular franchise. We now have three promising therapeutic candidates that Dr. Deitcher will take you through in some detail. But I do think that it's one of the most promising acute cardiovascular portfolios anywhere.

We expect to enhance our cash position. We've obviously had some success there, significant success. In fact, over the last eight months we've been successful at bringing in more than $100 million. In terms of building up our pipeline, we've obviously negotiated and executed a deal with Dendreon where we license the roll out rights to rNAPc2 specifically under investigation today for acute coronary syndrome which Dr. Deitcher will tell you about (indiscernible) the other opportunities that may be available for us with rNAPc2.

I mentioned that we did the deal with Archemix; it's actually a 50-50 deal worldwide where we share the commercial value of that compound 50-50 on a worldwide basis and also the cost. We successfully completed our Phase I program with alfimeprase and PAO and very rapidly moved from that program into two multinational Phase II trials that you will hear more details about today in peripheral arterial occlusion and in catheter occlusion. And finally, we completed our merger with Variagenics and remained the company and refocused our goal as we've already described under Nuvelo.

It really is a pleasure today, and I'm really not the expert, Walter Funk certainly is, but it's a pleasure today for me to just make a few comments about our research efforts. And I particularly want to do this at the beginning of the meeting because when George Rastin (ph) came here a number of years ago, three years ago, three and a half years ago, he was very focused, I know, on taking the gene discoveries all the way into product opportunities. And he and I have had many discussions about that over the years. We are making great progress on this so it really is a pleasure Walter and the research group and give you a little bit of update there.

We've divided our research efforts into really two areas, the first we call secretive proteins. These are genes that encode secreted proteins as they circulate in the body. And the unique things about these products is that these proteins are in fact the drugs themselves, so it's a very appropriate area for a company like us to focus. And we've managed to focus our efforts here through a collaboration with Terin (ph) where they are investigating in mouse models 50 such genes. We also have an internal effort where we are evaluating another approximately 50 genes.

So by the end of this year we expect to have very important -- hopefully very resilient (ph) information on approximately 100 genes in animal models where we introduced a test gene product into the animal and observed how it changes the animal. So very nice progress led by a small number of people in this company and executed extraordinarily well.

The second area of research that we focus on we call antibody targeting. This is an area where we focus on genes that encode proteins that are fixated in the cell walls. And the reason that's important is because these could be opportunities to target antibodies, specifically cancer cells. And we won't go into a great deal of detail here, but at the bottom you see (indiscernible) one example of one such target that we've identified and you can see the beautiful illumination due to the fact that this antibody is binding (indiscernible) to a variety of cancer cell lines and you can see there's essentially no binding in the normal cell. So it represents a great opportunity.

We have 18 (ph) such targets under evaluation and are making progress with them. So again, I'll end almost where I started. I just wanted to give people a flavor. I really think that the research group of this company has done an extraordinary job of making great progress and I'll look forward to telling you more about that as the story unfolds. We'll now turn to Steven Deitcher to give an update on our clinical program.

Thank you, Ted. Good afternoon. It's a pleasure for me to be a part of Nuvelo. Most recently I was the head of hematology coagulation medicine and director of clinical thrombosis research at the Cleveland Clinic Foundation and, believe me, that despite a vast array of career opportunities there's no place I'd rather be today than as a part of the management team of Nuvelo. I was drawn here by the people, the compounds I will discuss and the opportunities. Could we please have the first slide?

Alfimeprase is currently being evaluated in two indications. This is a summary of our Phase II trial in peripheral arterial occlusion. Briefly this is a multicenter open label dose escalation trial. There are three different doses being examined. The two which are being examined in the largest number of sub patients are the 0.3 and 0.6 milligram per kilogram dose. The target is to enroll 115 patients; we currently have sites open in the United States, Europe and South Africa. The lead investigators are Dr. Kenneth Orial (ph) from my past employer, the Cleveland Clinic Foundation, and Dr. Jacob Sinimin (ph) of the Montefiori Medical Center.

The main end points here are to evaluate for the rate of clot (indiscernible), the safety of the compound and clinical events. The dosing commenced in June of 2003 and we are on track to initiate our Phase III trial in the second half of 2004. As of today we have 104 of the 115 patients enrolled and we are right on track to complete the Phase II trial. We will give a topline data evaluation once we have enrolled the last patient and are anticipating presenting the full study data at a major medical meeting some time likely in the fall of this year.

We're encouraged by the results and as we are continuing, namely Dr. Lewis Pena (ph) and myself, to really push forward the Phase II completion, we're also in the process of finalizing our plans and moving forward with the Phase III program. Next slide please.

The second trial is in catheter occlusion, this is also a multicentered trial, it is randomized and double-blind. Three different doses of alfimeprase being tried against an approved dose of capflow (ph) in approximately 100 patients across 35 centers in the United States. The main end points being safety, restoration of flow to the dysfunctional catheters and the time to restore flow to the dysfunctional catheters. Dosing commenced in June of 2003, we are hoping to have interim analysis evaluated quickly after completion of enrollment of the initial 48 patients, we have 39 patients currently enrolled and thus are very encouraged to be in the single digits of remaining patients to accomplish our interim analysis goal. Next slide.

As this slide points out, on the top half of the slide it shows our two areas of active development, namely acute limb ischemia which we've also been referring to as peripheral arterial occlusion, and catheter clearance. But this compound as a tool to dissolve blood clots also has multiple other perspective development opportunities and clinical opportunities. These include the prospects for dissolving venous blood clots, pulmonary emboli and even a potential role in alleviating increased intracranial pressure in patients with intracranial hemorrhage.

If one were to ask me or allow anyone to design the ideal blood clot dissolver, namely thrombolytics, characteristics that we would be looking for are to have a drug which is rapid. We'd look for a drug that has a safety advantage compared to other drugs, and we would look for a drug that has a potential to lower the cost of managing patients with arterial or venous blood clots. How alfimeprase fits here is quite well. With regards to the rapidity of clot (indiscernible) alfimeprase is a direct vibro (ph) analytic meaning that the drug itself acts directly on the blood clot to dissolve it, unlike other available drugs which must act through an intermediary step mainly the conversion of plasminogen to plasmin.

This is important to note because if the blood clot which is the target of the therapy lacks plasminogen, then plasminogen activators will not work. Whereas alfimeprase would be able to work because it's the drug itself which does the dissolving. It is also expected to (indiscernible) in a matter of hours compared to the typical 24 and 96 hours which is the traditional duration of thrombolysis required in patients undergoing lysis for arterial and venous thrombosis today.

With regards to a safety advantage, the (indiscernible) activity of alfimeprase is confined to the site of drug delivery. Again, this is important, not only by delivering the drug directly to the site of thrombus are we able to dissolve it, but also the activity is limited to the site of thrombus so that the patient does not develop what's called a systemic lytic state which is usually the source of bleeding complications.

We feel that this localization combined with the fact that the drug is rapidly encapsulated by what's called alpha (indiscernible) globulins the minute it hits the general circulation and upon being encapsulated it is unable to act on additional blood clots, but this drug is unique in its safety advantage.

With regards to a potential to lower the cost, I think one of the main focuses is if you can do it safely and if you can do the lysis rapidly this could potentially be an out-patient procedure and we would not only limit the number of days patients might spend in intensive care units or the hospital in general, but reduce hospitalization cost. Also the lower incidence of adverse events could translate into reduction in both actual financial cost and cost to the patient with regards to morbidity and mortality.

I'll now briefly discuss rNAPc2. As a short bit of editorialization, rNAPc2 is a dream compound for a person who has spent over 20 years of their career focusing on homeostasis and thrombosis, basically the study of the mechanism how clots are formed and the treatment of patients who have bleeding disorders and clotting disorders. This is a unique compound and has a great set of opportunities in my opinion. This drug is a worldwide license from Dendreon; it is a novel anticoagulant, novel in the fact that it's designed to block the first step in the clotting cascade.

Now I'll show you a slide that depicts that further, but if you think about trying to stop a car it's easier to do it right before it starts driving than waiting until it has a full head of steam and it's going 65 miles an hour, or actually -- now that I've moved to California -- 80 plus miles an hour down the highway. So I think the point is to try to retard the progression of coagulation rather than trying to stop it when it's in full force which is the mechanism of other anticoagulant agents.

There is compelling patient data showing that rNAPc2 is safe and well-tolerated, it has the potential to be safe and effective in treating patients with vascular as well as select nonvascular disorders and I'll show you a slide that detects these two areas of potential opportunity. It is currently in a Phase IIa study in acute coronary syndrome and the potential market for both the vascular as well as nonvascular indications is huge.

The next slide shows what I was referring to with regards to acute coronary syndrome being our area of active development. This drug has a unique mechanism where it goes after what I'll call tissue factor and 7a. Tissue factor is sort of a trigger to blood correlation, therefore at the top of the cascade. In patients who have hardening of the arteries, in this case coronary arteries, the core of the hardened area is very rich in this tissue factor. If it cracks a bit so that the blood now becomes exposed to the middle of that hardening area that tissue factor gets exposed to the blood, blood clot forms and that's what leads to heart attacks and other what are called acute coronary syndromes. So it makes sense to target this tissue factor rich core of the hardening area of the artery with a drug that's specific for the tissue factor activated part of coagulation.

Other perspective development opportunities also could take advantage of the tissue factor, factor 7a target. This includes both the prevention as well as treatment of venous blood clots in high-risk groups. What I mean by high-risk groups, that would include for example patients with cancer. We know that approximately 15 percent of all patients with cancer will develop a venous blood clot at some point in time during the course of their disease. One of the major mechanisms by which cancer promotes the formation of blood clots is in a tissue factor mediated mechanism. Again, target the mechanism; you have the opportunity to have improved efficacy and safety.

At the same time we need to realize that in patients with cancer that what we're trying to do in the form of treating their cancer is prevent the growth of the tumor, spread of the tumor, namely metastases, in order to try to benefit the patient. It is now recognized that tissue factor in addition to its coagulation activities also may play a pivotal roll in the growth of tumor, metastases and what's called angiogenesis which is the end growth of new blood vessels to foster the growth of the tumor. So again targeting tissue factor may not only have benefits with regards to prevention of coagulation, but also potentially alter the biology of the underlying disease, and in this example I've given you that would be cancer.

Other opportunities would include sickle cell disease, inflammatory bowel disease, and percutaneous arterial intervention, that's where we put a balloon or insert stents in the arteries of the lower extremities or the aorta. So again, as I've already stated, I think the potential opportunities are vast and the markets which have the potential to benefit from our developments in these areas is also vast. Next slide.

This is just a cartoon to show you that a coagulation is felt to start up at this point and then there's an amplification down towards the formation of thrombin and the actual fiber and thrombus, but rNAPc2 is working up at the top of the cascade, not down at the point where the entire set of mechanisms have amplified and built upon each other. Next slide, please.

With regards to exposure rNAPc2 has been shown to be safe and well-tolerated in 550 patients. Included in the 550 patients are patients that were in an antidote study who were shown that the effect is rapidly reversed by the infusion of a commercially available agent known as recombinant 7a. When the initial Phase I study that was shown that this drug has a long duration of action of greater than 50 hours. This would translate into the need to give much less frequent dosing which may be extremely convenient to patients.

In a trial with regards to deep vein thrombosis prevention, it was shown to result in 50 percent less EDT development in orthopedic patients compared to (indiscernible) Heparin treated historical controls, and shown to be safe over a broad range of doses in a prior trial looking at percutaneous transnumoral (ph) coronary angioplasty. It has also been looked at in patients who are exposed to endotoxin and then the last row shows us the trial that we have ongoing, the Phase IIa trial, namely the Anthem trial also known as TIMI 32.

This is a novel anticoagulant as I have said. It's efficacy and the novel aspect is based on its upstream coagulation inhibitions. It has demonstrated efficacy in deep venous thrombosis and a potential for improved efficacy in other indications. There have been no safety or tolerance concerns observed after 550 patients of experience. It is a subcutaneously administered drug. There is no apparent need for monitoring and it has a long half-life which I've already stated may facilitate infrequent dosing. Next slide, please.

ARC183 is the newest addition to the clinical pipeline and certainly the earliest phase of development, this is a potent thrombin inhibitor. We came up with a term that is very accurate, that it has the -- a potential to give the clinician the opportunity to provide anticoagulation on command. And what I mean is instead of having to begin the infusion of the drugs and wait for the levels to gradually build up to achieve the desired effect, you can turn on the drug and get an effect very rapidly.

Similarly with drugs that are available already, when you turn them off you have to wait for the drug to be eliminated from the patient and that can take a matter of hours if not days. So again, if there were concerns -- you can't sort of stop on a dime to use the term. With this drug you can turn it off and upon turning off the infusion it has the potential to be out of the system in a matter of minutes. Targets acute anticoagulation applications, situations such as coronary artery bypass (indiscernible) surgery, acute myocardial infarction treatment, open and percutaneous vascular surgery. Situations where you want to turn on the anticoagulation and then when you no longer want the drug in the patient's system you turn off the drug.

There's compelling preclinical data. It has a shorter half-life and fewer side effects over currently approved anticoagulations. This drug is being developed in a 50-50 cost profit sharing collaboration with Archemix. It's poised to enter Phase I in the second half of 2004 and, as with the other products, has a large market potential.

The next slide is a depiction of what I was trying to do with my hand which is showing you that when you commence the drug there's a rapid uptick in the prolongation of a standard anticoagulation test. And during continuous infusion there's a nice, stable level attained and then upon turning off of the drug it comes down extremely rapidly with a functional half-life of approximately two minutes. Because of the fact that when you turn off the drug the effect goes away so rapidly there is a lack of the need to administer an antidote that is currently performed when patients receive Heparin, they receive the antidote at the completion of the surgery called protamine, protamine sulfate itself has the potential for side effects in the patients and it would be desired to avoid the need for administration of protamine.

With regards to coronary artery bypass (indiscernible) surgery, which would be the likely lead indication for development of ARC183, this is a surgical procedure to bypass occluded coronary arteries. There are approximately 520,000 of such procedures that are currently performed annually in the United States alone. Current anticoagulation regimen is Heparin and coagulation during the bypass with protamine sulfate reversal at the completion. There are approximately 2 million Heparin protamine exposures per year.

This Heparin protamine regimen poses serious side effects and limitations and as stated there are other potential indications including percutaneous coronary intervention, namely balloon angioplasty and the placement of stents with roughly 1.1 million such procedures performed in the United States annually. There are also noncoronary procedures where this could be useful such as patients undergoing hemodialysis. Next slide.

This is an anticoagulant truly for acute applications. Ultra short half-life therefore no need for a reversal agent. Has the potential to be safer with regards to reducing bleeding. This would not cause Heparin induced thrombocytopenia which is a condition where Heparin, a blood thinner itself, in approximately 3 to 5 percent of exposed patients actually promotes the formation of blood clots, a paradoxical hypercoagubility (ph). This drug, due to the fact that it has no molecular similarity to Heparin, would not promote that and actually would be a very effective treatment for Heparin induced thrombocytopenia.

The fact that one can avoid the need for providing a protamine antidote means that you can avoid a source of hypertension and allergic reactions derived from the protamine itself. This drug has the potential to be more effective than Heparin, it has a predictable optimal dosing or rapid onset of anticoagulation and a demonstrated ability to inhibit clot bound thrombin, something that Heparin cannot do. Next slide, please.

This is part of what attracted me to Nuvelo and California, which is an emerging cardiovascular franchise, a portfolio of drugs which have the capacity to prevent blood clots, treat blood clots and dissolve blood clots. For a person whose greatest interest is blood clots, you can see why I might be interested in a compound under development at Nuvelo. It goes along with my former license plate, namely CLOT MAN, and maybe I'll have to do that in California too.

But basically just to review, the drug (indiscernible) alfimeprase as a fiber analytic (ph) being evaluated in a Phase II program for acute peripheral arterial occlusion in a 50-50 collaboration with Amgen. Alfimeprase also being evaluated in catheter occlusions, rNAPc2, namely a tissue factor inhibitor currently in Phase IIa evaluation in acute coronary syndrome. But as I showed you with a vast array of potential opportunities. Nuvelo has worldwide rights to rNAPc2. And lastly but not least, ARC183, aptomer technology with a direct thrombin inhibitor, likely to be evaluated in coronary artery bypass graft surgery. IND is expected be filed in mid 2004, and this is being developed as a 50-50 collaboration with Archemix.

This is a cardiovascular franchise, the drugs are synergistic. As I've stated, we have drugs for preventing blood clots, treating blood clots, nonvascular indications as well as dissolving the blood clots that sneak through. This is an acute hospital-based cardiovascular product line, require a similar infrastructure for development and share development in commercial expertise. These are independent and important markets being addressed by the compound and potentially have a high probability of success based on preclinical and clinical data which is available to us now. Thank you very much and I'll turn the meeting back on over to Pete.

Thanks, Steven. We're obviously very fortunate to have you onboard and we appreciate the presentation. I'll spend a few moments to go through the quarter one financials and refer you to slightly more detailed financials that were issued in the press release in the past half hour.

In terms of the quarter one income statement, I hope I'm not disappointing anyone to show that we are reporting a net loss for the quarter. But as I think that most of you have seen, I think we're spending money in the right place. So in terms of the overall results for the quarter, we ended the quarter with a net loss of $17.7 million or 65 cents a share. The number of shares used for the calculation of EPS were based upon a weighted average share for the quarter which was 27.4 million shares.

In terms of our revenue, we have $642,000 in revenue which was primarily driven off of our subsidiary, Callida Genomics, and our operating expenses were $18.1 million. In terms of our operating expenses, 16.3 were expensed in R&D which included about -- a $4 million recognition of a payment made to Dendreon, 3.5 of which paid in stock but the $4 million was recognized in terms of expense for rNAPc2 and then about $4.8 million recorded for a $3 million cash payment to Archemix and 1.8 in continued development for ARC183.

As you can see in comparison to our previous year, our operating expenses went down substantially in the G&A area and that really had to do with the consolidation of our Variagenics and High C (ph) companies where we currently have one operation located in California. Next slide.

In terms of selected cash flow information or balance sheet information, I really will focus on the cash flow and the cash balance. We ended the quarter with a cash balance of $94 million which I've looked back and I believe is the highest that the High Seek (ph) and/or Nuvelo has ever seen in any one particular quarter. And we began the year with $34.2 million and added obviously $70 million related to our financing in March. Our net burn rate for the quarter was approximately $10 million which included $3.5 million in payments -- in cash payments, I should say, for license fees and collaborations related to rNAPc2 and ARC183.

We expect our burn rate for the remainder of 2004 to be between $31 and $34 million, that's for the next three quarters, and expect our 2004 year end cash balance to exceed $60 million. Given that balance we expect that we would have sufficient cash resources to fund operations through 2005.

As you're aware, we recently did do a financing and I thought it would be helpful to put that in perspective in terms of other financings that happened in the quarter in the biotech industry. Here's a listing that came from Needham & Co. that lists all the companies that filed in the first-quarter of 2004 to do a follow-on offering. So it does not include IPOs, or initial public offerings, or what we call PIPEs, private investments in public equities, and it does not include companies that raised under $20 million.

So you can see here in terms of the various companies listed by filing date, the number of shares offered, the amounts offered and the offer price. Some of the things that you would point to in terms of kind of a scorecard would be obviously the amount offered but then also kind of what happened to the stock on -- on the day of filing and then on the day of pricing. And so in terms of the offer amount that we raised gross proceeds of close to 75 million which in terms of this list for the quarter were only exceeded by two companies, (indiscernible) kind of third.

In terms of offer price as a discount to the price on the filing day, we were down about 5.4 percent and that compares pretty favorably to these other companies that are listed, especially if you look at during this period of time when the market, due to geopolitical issues and general issues, was very choppy while we were out on the road. And then more importantly to look at on the day before we actually priced a deal at $13 a share we were trading at $13.21. So there was a minimal discount in terms of the overall offering price which kind of placed us third on this list in terms of minimal discount.

And to our knowledge in terms of these companies we were one of the few upsized deals meaning as we presented our prospectus we filed to sell 4 million shares and actually ended up with demands to where we could actually sell 5 million shares with no obviously issue of degradation of the stock price that we saw on the pricing there. I think that's all I have for the financial update. I'll turn it now over to Ted.

I wanted to wrap it up with a few comments. Specifically talk a little bit about the milestones that you can be expecting from the company over the course of this year, starting with the clinical programs and specifically with alfimeprase. We expect to be, in the very near future, completing the enrollment in the PAO trial as described by Dr. Deitcher. We also expect to, in the very near future, complete the interim analysis in our catheter occlusion trial after we enroll the first 48 patients.

We also are moving forward with our goals, getting the Phase III program started in the second half of this year on schedule. And finally, on alfimeprase, the Phase I data has not yet been published, although they have been accepted and will be published in a major medical journal.

Moving to rNAPc2, our first goal was to reinitiate a previously discontinued or previously put on hold Phase IIa trial. The first goal there was to actually get the drug back on stability. We have moved very aggressively and very rapidly and succeeded at that and are imminently reinitiating that program.

Turning to ARC183, we expect to file the IND in the first half of this year, and again our Phase I clinical program in the second half of the year. And in coming back to research again, as I mentioned, we expect to make progress with our Terin (ph) collaboration and our internal collaboration on a large number of secreted protein genes as well as our antibody programs with the ultimate goal of advancing at least one of these research programs into IND enabling studies in the second half of this year.

We are also in discussions -- early stage discussions with a number of companies around business development alliances to further advance and accelerate our research efforts in antibody targeting and secreted protein development. And lastly, we continue to make progress on our efforts to divest our noncore assets specifically from Variagenics and Callida, our subsidiary.

Again, kind of putting things in perspective, Nuvelo has definitely moved forward and established itself as a leader in terms of having an acute cardiovascular franchise; we are very proud of that. We believe that we have a solid pipeline of therapeutic progress and we are executing on moving those forward. In order to do this we have built a strong cash position and we expect to maintain that cash position in a strong manner going forward. Our drug discovery efforts have risen to a level that I think we can call robust and I think we can look for to those being part of a (indiscernible) flow from the company that's steady and significant as we go forward.

Highlights are also in (indiscernible) the management team; I have been very blessed to have a very talented group of people around me starting specifically at the top with George Rathmann (indiscernible). This actually completes the phase of the meeting and our conference call. I'd like to thank all the people on the call for joining us today and let you know that while you don't have the opportunity to ask questions you should feel free to call Nicole Estrin or Pete Garcia with questions after the call. Mr. Garcia's number is 408-215-4574 and Nicole Estrin can be reached at 408-215-4573. That completes this portion of the meeting. Thank you for joining us again.