Oruka Therapeutics Inc (ORKA) 2004 Q2 法說會逐字稿

Please stand by. We’re about to begin. Thank you for standing by and welcome to the Nuvelo’s Q2 2004 Financial Result Conference Call. Today’s call is being recorded.

This conference call contains forward-looking statements regarding the development and commercialization of Nuvelo’s potential therapeutic products and guidance as to Nuvelo’s anticipated results of operations, which statements are hereby identified as “forward-looking statements” for purposes of the safe harbor provision by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management’s current expectations and involve risks and uncertainties.

Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties related to drug discovery, clinical development processes and the development and commercialization of our molecular diagnostic technology, changes in relationships with strategic partners and dependency upon strategic partners for the performance of critical activities under collaborative agreements, the impact of competitive products and technological changes, uncertainties relating to patent protection and regulatory approval, and uncertainties relating to our ability to obtain substantial additional funds required for progress in drug discovery and development.

These and other factors are identified and described in more detail in Nuvelo’s filings with the SEC, including without limitation Nuvelo’s annual report on Form 10-K for the year ending December 31, 2003 and subsequent quarterly reports on Forms 10-Q. We disclaim any intent or obligation to update these forward-looking statements.

Now, at this time, I’d like to turn the conference over to the President and CEO, Dr. Ted Love. Please go ahead.

Good afternoon and thanks for joining Nuvelo’s second quarter investor conference call. We’re very pleased to discuss our major recent accomplishments, as well as our upcoming milestones.

The agenda for the call today will be as follows. I’ll begin with a discussion of some of our highlights, accomplishments, and milestones. Then we’ll ask Dr. Steven Deitcher, our VP of Clinical and Regulatory Affairs to give a more detailed clinical update. Then we’ll ask Mr. Gary Titus, our recently promoted VP of Finance and Chief Accounting Officer, to review our financials and then we’ll end with our usual Q&A period.

Starting with major accomplishments, there are 5, which I’d like to discuss.

First, we’ve done, I think a very good job of building on an already strong base of a management team and added additional strength. Specifically, we’ve hired Mr. Lee Bendekgay to join us as SVP, CFO, as well as General Counsel. We’ve also hired Mr. Simon Allen to join us as VP of Corporate and Business Development and as I mentioned, we promoted Mr. Gary Titus to the role of VP of Finance and Chief Accounting Officer.

Secondly, I’d like to give you some update on the progress that we’ve made on alfimeprase. As you know, we’ve completed both - I said both - of our Phase II alfimeprase programs and we’ve already presented interim data on the first 87 of 113 patients at the Vascular Surgery Annual meeting this past June. The data from that presentation are available on our website.

Finally, the full data set from 113 patients from that Acute PAO study will be presented very shortly at the Transcatheter Cardiovascular Therapeutics (TCT) 2004 meeting on September 30th in Washington, DC.

Thirdly, we filed the IND for ARC183 in June of this year and announced today the initiation of the Phase I trial. This was all done precisely on the schedule we’d promised.

Number four, we’ve reinitiated our Phase IIa trial with rNAPc2 in patients with Acute Coronary Syndromes (ACS), again exactly on the schedule that we had promised.

Fifth and finally, Nuvelo has been selected to join the (NASDAQ) Biotechnology Index.

In terms of upcoming major milestones, there are 4 of which I’d like to point to. Again, these are driven by the success at completing our two Phase II alfimeprase trials.

So, looking first to the Acute PAO clinical program, we’ve made great progress in gearing up for our End-of-Phase II meeting with the FDA. We’ve had conversations ongoing, which have been positive and highly constructive.

It now appears that our End-of-Phase II meeting with the FDA will occur in early October. Most importantly, we are taking every effort, at this moment, to prepare to begin our Phase III clinical trials as soon as possible after our End-of-Phase II meetings with the FDA. And we expect to begin enrolling in that trial toward the end of 2004 or the early part of 2005.

The second major milestone I’d like to discuss is presentation of our Acute PAO data. I’d like to mention that the interim data was presented at the SCS Annual Meeting in Anaheim in June of this year. The data were highly encouraging to us as well as our investigators. As we announced today, the complete Phase II data from that trial will be presented at the Transcatheter meeting in Washington, DC on September 30th.

Dr. Ken Ouriel will be going to that presentation. As you know, Dr. Ouriel is a highly prominent vascular surgeon and leader in the medicine of advancing Acute PAO treatment. He’s also Chairman of the Division of Surgery at the Cleveland Clinic Foundation and he’s already agreed to be Chairman of the Steering Committee for our upcoming Phase III trial in Acute PAO.

The third milestone I’d like to talk about is the Catheter Occlusion Program. At the beginning of July, we were fortunate to be able to make a strategic decision to conclude our Phase II trials early. That trial had enrolled 56 of the planned 87 patients. The key driver of that decision was having answers to the key questions that we set out to answer with the trial.

1. What is the approximate dose range required for alfimeprase in the treatment of patients with catheter occlusion?

2. Can alfimeprase open catheters rapidly, compared to Activase Cathflo?

Having had significant insights in the first 56 patients, again, we were fortunate to be able to make a strategic decision to successfully conclude that trial. The next step with this program will be to meet with the FDA and discuss approval trial designs in the end of Phase II meeting.

The fourth milestone to discuss is Amgen’s decision regarding licensing our continued 50-50 partnership with Nuvelo. Mechanically, the way this will work is 30 days after we present the Phase II data to Amgen, they must make a decision regarding this.

I think it’s important to give people a bit of history on how this arrangement came about. I’ll remind people that at the beginning of ’04, when Nuvelo established a [inaudible question - background noise] with Amgen, we were burning approximately $60m per year and we had only approximately $2.0m of cash in the bank.

So our capacity to do a traditional licensing deal competitive with the deals that Amgen was discussing was not in line with our financial situation. However, Amgen felt that we’d be a strong partner, clinically, to advance the molecule and they were willing to work with us to create a financially attractive deal for them to be able to move this forward.

In terms of Amgen’s decision, we can’t predict what they will do, but what we can say is that we’ve worked very hard here to make sure that the alternatives for Nuvelo and our shareholders are attractive in either situation - in other words, a win-win for us. If Amgen chooses to continue with the partnership, we would be delighted with that. We’ve had a wonderful partnership and collaborative relationship with Amgen. We’ll be happy to do so.

Alternatively, if Amgen were to become a licensor of the drug to us, we would be in a position to own 100% control of the drug commercially, seek out a partner, or seek other arrangements to move the drug forward. At end of the day, it boils down to the characteristic of the drug and the opportunity for the drug and we obviously are quite excited about those data related to alfimeprase.

Lastly, I’d like to point out that we’re talking about starting our Phase III program at the end of this year or early in ’05. I want to stress that that is exactly the timeline that we announced to the investigative community and investor community after doing the deal with Amgen. I think, number one, this validates Amgen’s confidence in selecting us as a clinical partner, and I think it also validates our commitment to investors in terms of meeting our corporate timelines.

At this point, I’d like to introduce Dr. Steven Deitcher. Dr. Deitcher is our VP of Clinical and Regulatory Affairs. He was formerly Head of Hematology and Vascular Medicine at the Cleveland Clinic Foundation and also our principle investigator for our Catheter Occlusion Program. Steven?

Thank you, Ted. I’m thrilled to be on the Nuvelo team.

Now that we have finished presenting the favorable recent history for alfimeprase, I will now discuss our other exciting clinical programs, namely those revolving around rNAPc2 and ARC183.

I will start by reviewing the rNAPc2 program. RNAPc2 is a licensed anticoagulant. We licensed it from Dendrion in February of 2004. We reinitiated Phase IIa trials in patients with ACS in May of 2004. This trial is being conducted with the TIMI study group led by Dr. Eugene Braunwald of Brigham and Women’s Hospital and Harvard Medical School.

This molecule is an anticoagulant. It is designed to specifically block the first step in the clotting cascade. This is in distinction with other anticoagulants. The anticoagulant effect of rNAPc2 results from its apparent ability to block the Factor VIIa tissue factor protease complex, which is responsible for the initiation of the processes leading to blood clot formation.

We know that it is an anticoagulant and it has been demonstrated to be an anticoagulant in over 500 patients to date. What we also are interested in is the fact that the unique target - namely tissue factor - leads us to believe that rNAPc2 may have other potential roles in the management of disease in general and in disorders which are associated with a high risk of thrombosis in particular.

Moving forward, we are going to have an rNAPc2 Summit. This Summit will, in part, be to discuss our ACS program, as well as to discuss the other areas where rNAPc2 may have a role in medicine. We will explore these other development areas including thrombosis in the setting of cancer, disorders associated with inflammation, and disorders such as Sickle Cell disease.

Our strategy, moving forward with rNAPc2, includes completion of the current portion of our ACS trial and making a decision on a strategy for moving forward in this indication. Additionally, our strategy includes exploring partnering opportunities in order to allow us to exploit all potential indications for rNAPc2. The results of the Summit, which I have already described, will assist us in moving forward along this pathway.

I will now briefly review ARC183.

We announced a 50-50 collaboration with Archemix in January of 2004 for the thrombin inhibitor known as ARC183. An IND was filed in June of 2004 and we announced today the commencement of dosing in our Phase I trial.

The Phase I trial design includes an open label dose escalation study to evaluate the safety, tolerability, anticoagulation activity, and titratability of ARC183. The initial portion of the Phase I program will be performed in 16 normal volunteers.

Following assessment of this first part of the program, we plan to evaluate ARC183 in an additional group of patients with stable coronary artery disease.

ARC183, for those who are not aware, is an aptamer. It is a direct thrombin inhibitor. It is a single-strand - 15 bases long - of DNA. In its unique conformation, it is capable of inhibiting soluble thrombin as well as thrombus-bound thrombin.

Pre-clinically, it appears to have a shorter functional half-life than other anticoagulants. It has a very short functional half-life of approximately 2 minutes. Thus, postoperatively, there would be no need for a reversal agent or antidote should ARC183 be used.

It has the potential to reduce bleeding, should not pose any risk of heparin-induced thrombocytopenia, and may reduce the risk of hypotension and allergic reactions caused by protamine, which is frequently utilized as a reversal agent following the administration of heparin during cardiopulmonary bypass.

With regards to an initial indication for ARC183, we are targeting acute applications where heparin/protamine are currently used for anticoagulation. Thus it is currently being developed along a pathway for potential use in coronary artery bypass graft (CABG) surgery.

I will now turn the call over to Gary Titus, our VP of Finance and CAO, to discuss our Q2 2004 results. Gary?

Thanks, Steven. Good afternoon, everyone.

At this time I would like to discuss the financial results for the first half of 2004 and the financial outlook for the remainder of the year, including the continued financial impact of our two new development programs.

Turning to our 2004 YTD results, for the three months ended June 30, 2004, we reported a net loss of $11m or $0.34 per share, compared to a net loss of $16.3m or $0.77 per share for the same period in 2003. For the YTD through June 2004, we reported a net loss of $28.6m or $0.97 per share, compared to a net loss of $29.9m or $1.59 per share for the same period in 2003.

The decreased net loss resulted primarily from the discontinuation of our Variagenics business in Cambridge, Massachusetts last year and continued efficiencies in our Sunnyvale operations. This decreased net loss was partially offset by increased expenses incurred in connection with license and collaboration fees and development expenses relating to our rNAPc2 and ARC183 drug candidates.

The number of shares used for the calculation for the YTD EPS is based upon weighted average shares outstanding during the YTD period, which were 29.6 million shares.

In terms of our revenue, we recognized $910,000 in revenue for the quarter and $1.6m for the YTD. Our operating expenses (OpEx) were $11.9m for the quarter and $30m for the YTD.

In terms of our OpEx, $26.1m was spent on R&D for the YTD, which includes a $4.0m license fee payment to Dendrion in the first quarter for our drug candidate rNAPc2, $3.5m of which was paid in stock.

In addition, we expensed about $5.9m for our drug candidate, ARC183, including a $3.0m collaboration fee paid to Archemix and about $2.9m in continued development costs.

In terms of selected balance sheet information, I will focus on cash flow and our cash balance. We ended the quarter with cash and cash equivalent balance of $80m. We began the year with $34.2m and added approximately $69.5m related to our public financing in March.

Our net burn rate for the YTD is approximately $23.7m, which includes $3.5m in cash payment for license and collaboration fees related to rNAPc2 and ARC183 drug candidates.

At this time, I’d like to give some financial guidance on our cash burn rate for the remainder of 2004 and our near-term financing strategy. We anticipate a net cash burn rate of $40-44m for 2004. The key drivers behind this burn rate is the ramp up of our clinical development operations in anticipation of our alfimeprase Phase III trials in PAO and Catheter Occlusion, continuation of our current Phase IIa trial with our rNAPc2 drug candidate, and our Phase I trial with ARC183. In addition, we will continue to incur significant costs associated with manufacturing of drug products for our clinical trials.

Finally, we have begun to share clinical developments and manufacturing costs on a 50-50 basis with our collaboration partner, Amgen, and our ARC183 drug collaboration partner, Archemix. These two factors will allow us to continue our current cash burn rate for the rest of 2004.

Given our current cash balance of $80m, we expect that we will have sufficient cash resources to fund operations through 2005. We will provide additional guidance on our 2005 cash burn rates in the near future, as we finalize our two Phase III alfimeprase clinical trial protocols.

In terms of financing strategy, given our cash balance we anticipate carefully evaluating equity market conditions and our current cash requirement for the continued development of our three clinical candidates, in determining the appropriate time to approach the financial market.

This concludes the financial update. I’ll now turn the call back over to Ted.

Thanks, Gary and Steven.

Before we take questions, I’d like to outline some of our important upcoming milestones. I think we’ve already had a very exciting summer, but we’ve still got significant news in the very near future.

There are 8 near-term milestones that I’d like to walk you through:

1. Our Phase II PAO data will be presented at the TCT meeting on September 30th in Washington, DC.

2. We will submit publication for our Phase II Catheter Occlusion trial before the year is out.

3. We expect to have an End-of-Phase II meeting with the FDA for our phase III alfimeprase program in the coming months.

4. We expect to initiate our Phase III PAO trial at the end of this year or the beginning of ’05.

5. We expect to communicate to you the decision, with regard to Amgen and our collaboration and shortly thereafter what we would do in response to that, in terms of moving alfimeprase forward.

6. We expect to announce completion of our Phase I ARC183 program over the next couple of quarters.

7. We expect to continue to advance rNAPc2 in ACS and also establish clarity on additional opportunities for this drug to meet unmet medical needs beyond ACS.

8. And finally, we expect to advance at least one additional internal product candidate into IND-enabling studies by the end of this year and we look forward to sharing information on these research programs at a later date.

In summary, we’re making rapid progress on all three of our clinical programs, including alfimeprase in PAO and catheter occlusion, ARC183 in CABG surgery, and rNAPc2 in ACS and other potential indications.

With that, we’d now be happy to entertain your questions.

Very good. (Caller Instructions.) Our first question will come from Mark Monane with Needham & Company.

Hi, good afternoon, everybody.

Hey Mark.

Please, could you spend some time talking to us about your Phase III alfimeprase program? How did you make a decision about PAO versus CO for the Phase III trials and then, after you talk about that, can you talk about the competitors out there for each of these programs and what challenges or benefits alfimeprase could bring to the marketplace?

Thanks, Mark. Steven, do you want to take that?

Certainly. With regards to the first part of your question, why we are pursuing PAO, first I would respond by saying that we have every expectation to pursue both PAO and catheter occlusion. The decision to pursue PAO first is due to the availability of our complete data from our Phase II trial sooner than we have the full data set from our Phase II catheter occlusion trial. So I don’t view it as an either/or. I view it as just one coming in sequence before the other.

With regards to the competitive landscape in PAO, I think we’re looking at two real areas of competition. One is the other thrombolytics, which are the plasminogen-activators and then, secondly, mechanical thrombectomy. With regards to other thrombolytics, we’re looking at plasminogen-activators as a therapy for the restoration of flow in patients with PAO.

Unfortunately, based on past experience and published literature, that is accomplished at the expense of a bleeding rate of up to 12.5% and an intracranial hemorrhage rate that ranges somewhere between 1.5% and 2.5%. It is also accomplished over a much greater period of time than is most likely clinically prudent.

Meaning that it takes on average a 24-hour infusion of a plasminogen-activator in order to achieve successful thrombolysis. Thus, a newer thrombolytic that would lack the toxicity profile of plasminogen-activators and be able to accomplish restoration of flow in a matter of hours instead of a matter of days, would be a wonderful advancement in the field.

With regards to mechanical thrombectomy devices, I’ll refer to an article which was published in the January Journal of Vascular and Interventional Radiology, which explored the practice and behaviors of physicians who treat acute PAO patients. And to paraphrase and summarize the findings of that study, well over 90% - almost 95% - of the physicians indicated that thrombolytics would play a role in their management of these patients and that under 5% of these physicians felt that they would use a mechanical thrombectomy device alone to manage these patients.

So, I foresee alfimeprase fitting in as either the only means of getting rapid and effective and safe restoration of flow or to be used in the future in combination with mechanical thrombectomy devices in selected patients.

With regards to catheter occlusion, I think again the major competitors in the future would be other thrombolytics, namely the plasminogen-activators or surgical removal and replacement of a catheter. The other plasminogen-activators are used. I think what we’re looking at, though, again, is can one achieve patency of an occluded catheter not only at the same rate, but to do so faster.

I think that if you look at the currently available agents, treatment usually takes two doses, with a delay from start of treatment to maximal success rate of 4 hours. If one could dramatically reduce that span of time, I think we would improve patient care, as well as improve the efficiency of physicians’ offices and this makes such an agent preferred.

I think it’s quite obvious that to ask a patient, who is most likely already had surgeries and is dealing with serious illness, to go have an additional procedure to remove a catheter and have a new one placed is not in a patient’s best interest. And there’s also a significant cost associated with it.

Terrific. Thanks for the detailed answer and congratulations on your progress.

Thank you very much.

And we’ll next go to Matthew Geller with CIBC World Markets.

Hi, thanks. Can you talk a little bit about what the content might be of the post-Phase II meeting with the FDA, what issues you expect to encounter? Might you do an FTA for the Phase III trials for alfimeprase?

Again, Steven’s been leading all of those interactions with the FDA, so Steven, would you mind?

No program, appreciate the question. We have been working very closely and very collaboratively with the team at the FDA, which will be attending and presiding over our end-of-Phase II meeting. What we’ve been discussing is how to best bring alfimeprase to market and utilize the advantages that we feel have been demonstrated in clinical trials to date.

I’m really not able to give you specific details of the trial, but I will tell you that our discussions with the FDA are focusing on establishing the endpoints and trying to establish endpoints which will assure that we meet the needs of patients, the FDA, and Nuvelo.

One of the items that we are also discussing are the pros as well as the cons of different pathways such as a special protocol assessment. And we will continue to have those discussions, weigh the pros and cons, and make a final decision most likely after we have had the opportunity to present our full Phase II data and have a discussion about Phase III design with the FDA itself.

Great. Thanks a lot.

You’re welcome.

And we’ll next go to Charles Duncan with JMP Securities.

Hey, good afternoon, folks, and thanks for taking the call. First of all, congratulations on a good quarter of progress and secondly, I have a couple of questions. One is back into PAO Phase III. I know it’s very difficult, at this point, to lay out the exact details of the design. But could you order of magnitude it for us with regard to the amount of patients that you’re looking to with the different scenarios and actually the costs involved in doing the full Phase III development for alfimeprase?

Hi, Charles, this is Ted. Steven, since you’ve been leading this, you might as well continue.

I’ll address the clinical part and maybe I’ll leave any issues pertaining to cost for you, Ted.

With regards to the clinical program, when we’re looking at catheter occlusion as well as PAO, we need to appreciate that historically, for approval of an agent, the FDA has required somewhere in the range of say 1,000 to 1,500 total patients, so that both efficacy and safety claims can be made. So I’ll emphasize again that that number is for a total program, not for just one or the other indication.

With regards to the design for the PAO pivotal trial, where the primary endpoint is an efficacy endpoint, we are trying to base our design on an endpoint and sample size that will provide us the greatest likelihood of success.

So, to pinpoint a number right now is a little bit premature, but I think that we’re striving to limit the size so that we can hopefully have the most efficient progress and the greatest amount of progress in as limited a period of time as possible.

Obviously any cost projections would hinge on the actual sample size and again, as I stated, one cannot pinpoint that number. We can’t pinpoint that number until we further our discussions and finalize our plans with the FDA’s input.

Would you be willing to give us kind of an order of magnitude or best case/worst case scenario on the cost?

I think, at this point, Charles, especially given our collaboration with Amgen, we probably should not venture into specific numbers. What I can try to give you and other investors some assurance on is that we’ve made plans for doing trials with certain cost estimates. None of interactions with the FDA or anyone suggest that those projections are not accurate.

So we fully expect that what we budgeted and we what project to people in terms of our future burn rate will, in fact, be accurate. No reason to change those. The only reasons those numbers could obviously change would be the relationship with Amgen, as we’ve already discussed, and again, we have a great deal of options in terms of that to cover additional costs if that situation arises.

Pete -- or excuse me, Ted, when you said that you had adequate cash to make it through 2005, could you give just some idea of approximately the amount of cash that you envision spending on the Phase III program next year?

Well, we’ve never broken it out specifically by program. What we’ve said is that we’d expected to burn approximately $40-44m in ’04 and we continue to feel that. We’ve also given people guidance in the past that in ’05 we would expect to spend somewhere in the range of $45-50m.

Now, obviously, we might change that number or update that number toward the end of this year. But that’s been the previous guidance, and based on today, I have no reason to change that and also, based upon our financing and the statement that we have adequate funds to move through ’05 continues to be true as well.

And then one last question on Amgen. I know you work at Nuvelo. You don’t work at Amgen, but could you help us? In your previous discussions with what some of their hot buttons appeared to be with regard to evaluating whether or not they wanted to be involved in this collaboration. And then finally, have you actually submitted the Phase II data or when do you anticipate doing that?

Let me take them one at a time. Number one, what I can say is that you’re correct: I don’t work at Amgen and I could not speak for Amgen. But you do know I spent a fair amount of time at Genentech and thought a lot about how at least at Genentech we made certain decisions.

What I would probably say, at least from that perspective is that the expected commercial value, which as you well know is very hard to estimate, would be a significant part of Amgen’s decision. And I would also imagine the strategic direction that Amgen thinks they’re going would be a relevant decision.

I can tell you that all of my interactions with Amgen around the data have been very positive. They’ve been quite consistent with our view of the data and that is that alfimeprase looks like a very promising agent. So, I don’t think the data specifically is a particular area of concern. But again, that’s me speaking and not Amgen speaking.

In terms of going forward, I think your question was about some of our different strategies. We obviously, going forward, if Amgen were to stay in the partnership 50-50, we’d be delighted with that. We’ve had a great collaboration with Amgen and fully expect we’d be very excited about continuing with that.

Alternatively, Amgen needs to make its own decisions and we are, at the end of the day, more concerned with Nuvelo than Amgen, with all due respect, and therefore, we’ve thought very hard about the various alternatives for us. So we’ve actually worked through a set of alternatives where Amgen’s decision is really not the primary issue for Nuvelo.

The primary issue for Nuvelo is to have attractive options, irrespective of what Amgen chooses and we’ve done that. So we’re not prepared to communicate those specifics today. But I can communicate we’ve done that work and we’re prepared for either decision and to win with either decision.

When do you anticipate submitting the full data to Amgen?

We’ve not submitted it as of today. I don’t think that we will communicate publicly when we’ve done that.

What we will communicate to people is probably what people care about, is when we know Amgen’s decision and we’ve sorted through how we’re going forward with alfimeprase we will communicate that. But the specific data of when we submit the data to Amgen, number one, has not occurred and number two, we probably will not communicate that when it happens.

Would you submit the data to Amgen before you get direction from the FDA? Or could those two events coincide?

Those events are unrelated events.

Yeah, I understand, but could they actually --

I mean, they’re totally insignificant.

Could they actually coincide in terms of timing or do you feel obligated to submit the data to Amgen sooner than the FDA meeting?

We have a contract with Amgen, which really dictates how we interact with Amgen and we will abide and follow the contract. That does not have any tie into the FDA.

Well, I guess what I’m asking you, Ted, is do you need to give them that data now or can you wait until after you get some feedback from the FDA?

We’re not planning on waiting until we get feedback from the FDA. We’re planning on submitting the data to Amgen based upon an agreement with Amgen about what data is required to facilitate that decision by the contract. But it has nothing to do with the FDA. That’s what I was trying to point out. They’re totally unrelated events and we have no intention of linking them.

But the decision with Amgen is likely to occur before you get some feedback from the FDA or before it’s a final end-of-Phase II meeting.

That I’m not commenting on.

Okay. Thanks.

Our next question then comes from Frank Petronis [ph] with Wachovia Securities.

Hi. I just want to congratulate you on your success and just like the program Jeopardy, things I can’t say, I can’t identify with, the only comment I do have is as follows. I am formally a retail broker with Prudential, Dean Witter, and now inactive with Wachovia, with quite a few retail clients. My only problem is trying to get research reports like Needham and Oppenheimer to the little people.

It seems like the institutions and those have first-hand data and with the let’s say the WorldCom/Enrons of the world now falsifying K’s and information such as that, I feel that 100% disclosure would be forthcoming. And that all of our shareholders and/or possibly new shareholders can and should get these reports.

When I called Needham in particular, they declined to even send me, a former broker and/or any retail type people, these research reports, which I think contain enough information other than your product and your pipeline of products that we may or may not understand.

But I would hope that you can clarify and answer that the research reports and other than a simply buy, sell, or hold would be needed and I thank you for your answer.

Maybe what I can say is that I don’t think that, as a Company, we’re in a position to be distributing our research reports written by analysts at various banks. What I can say is that we work very hard to make sure that we, as a Company, are properly and adequately communicating the status of our program and the status of our Company. And I think we do a fine job of that, both on our website as well as in our SEC filings.

So, I think that the information is all out there. Unfortunately, I’m not in a position to provide analyst reports to various banks. I don’t think any CEO is. But I do think that we provide a great deal of high quality information about the status of our programs and about the status of Nuvelo.

Oh, absolutely, Dr. Love. But my only question is that it seems unfair that the major institutions, banks, and brokerages should have access to those reports where the average stockholder has no way doing a little legwork and/or getting anything other than information from the Q, K, 8-K and other filings that are coming down.

I’m saying that basically it seems like -- and this is not only Nuvelo. It seems like all the companies, at this point in time, they are in this Twilight Zone that no one seems to be getting the so-called good, bad, or indifferent research reports that are available only to the chosen few.

And I think this is very detrimental to the stockholders that, again, what decision have they come to, to say okay, hold it, buy it, or sell it. And we are not privy to any of that and I’m back on the bench where I’m a normal stockholder via a producing retail broker.

Well, all I can say is I appreciate your dilemma, Mr. Petronis, but we’re not in a position to control any of those factors.

Okay. Thank you very much.

Uh-huh.

Our next question will come from David Wood with Rodman & Renshaw.

Good afternoon, just a couple of questions. First, you had mentioned that in early October, that was your expected timeline for the pre-Phase III meeting with the FDA. Are you going to somehow communicate to us the results of that meeting or are you going to wait until you’ve had time to digest that and have come up with a Phase III protocol? What can we sort of expect, going forward, on that?

I think you can expect a communication fairly quickly after we gain closure with the FDA. Obviously we do have our partnership with Amgen, and assuming that we remain in the 50-50 relationship, that would be an important partner to also reach agreement with. But I would not expect a significant delay between us reaching agreement with the FDA and communicating that.

Okay, great, and the other thing about catheter occlusion. You said that there would be a publication, I believe, submitted by year-end.

Correct.

Okay. That’s correct. Are we going to be able to see that data in any other form prior to publication?

Steven?

The interim data from the catheter occlusion trial was actually submitted online today to the American Society of Hematology. Which holds it’s meeting in the first weekend of December, so that we would have the expectation that that abstract will be published by the first week of December of this year.

We’re also planning submission to another meeting and if these submissions are accepted for presentation, we’ll have the opportunity at those meetings to present not only the interim data, but the entire data.

So, our publication and presentation strategy, we’re again trying to be very assertive and get ourselves to the appropriate and a nice broad spectrum of meetings where we will have contact with the physicians and nurses. That would be the likely users or prescribers of our compounds.

So the second meeting, then, is the logical in that it would be more of the complete data set, as opposed to the interim data at ASH?

Well, even at ASH, the abstract for these two meetings will have the interim data, but by the time that any presentation would take place we would be in the position to present the total data.

Okay.

So, in some ways, it pivots on whether we purely have publication of the abstract or whether we are concomitantly granted the right to present our data in the form of a poster or oral presentation.

Okay, great, and this other meeting, would you say it’s -- is it before or after ASH or is that to be determined?

The other meetings to which I am submitting the abstract would be after ASH.

Okay, great and then one last question, if I may, as I know time is tight? Can you just give us an update on rNAPc2? I know that you had reinitiated enrollment in mid-May. Can you give us sort of a status update on that?

It is enrolling. It’s actively enrolling. As you know, enrollment rates can hinge upon the number of active sites, so we are not only continuing to actively enroll in this trial but are also seeking additional, active, and very interested sites. This is good for us. We work very closely with the TIMI Group and have basically mutual benefits to this particular trial and program. We’re very excited about the program. We think that this gives us a great opportunity to look for a signal.

And we are very much looking forward to having our summit, which I described, which will include members of the TIMI Group, as well as distinguished scientists and clinical scientists in a multitude of areas. Where we’re going to draw upon the cardiovascular experts in the country. We’re going to call upon vascular and angiography experts across the world. We’ll have attendance by oncologists, basic tissue factor scientists, hematologists, infectious disease physicians and really put together and elite core of individuals. Not just to hear what these different disciplines have to say about the prospect of rNAPc2 in their diseases, but to feel that, for example, having expert oncologists discuss how they would use the compound and then, get feedback from other disciplines that will give us some great insight into pathways that we might take in addition to ACS.

Okay, great. Just in terms of enrollment, are there a number of sites that you can tell us they’re up and running now or what’s the total number you are -- is there a set number you’re looking for or is that sort of a moving target?

I would tell you that the number of sites is a bit of a moving target and that the number of sites changes frequently. We have a number of sites that, for example, have contracts and are ready to go but are waiting to, say, receive drug. So it’s really hard to throw out one number and have it pinpoint accurately the status of the trial.

And with regards to the current status of enrollment, all I can tell you is that the target for the total enrollment of this part of the Phase II trial is 175 subjects and we are on our way.

Great. Thank you.

You’re welcome.

We will next go to Clay Wilson with Needham & Company.

Yes, hello?

Your line is open. Please go ahead.

Yes. I’m sorry. I thought I got cut off. I was wondering if you could comment on the peripherally inserted central catheter and how that might affect the catheter occlusion market?

Well, I think, just for those who might not know exactly what you’re talking about that most central lines historically, which have been placed in patients to facilitate infusions of fluids, antibiotics, nutrition, but most commonly placed to facilitate intravenous chemotherapy, are placed into either a neck or a vein that runs behind the clavicle. And then there’s either an externalized catheter or a port, which is placed subcutaneously, sort of on top of the chest wall but below the skin.

A newer type of catheter, which is, I think, gaining popularity is one that’s actually placed in the arm vein, such as the crease of the forearm and the upper arm in the elbow area, and then advanced forward into the central venous system.

These have been studied quite carefully, including studies published by my former colleagues at the Cleveland Clinic Foundation, demonstrating the fact that when you examine these patients for the development of blood clots, even if these peripherally inserted catheters are only in place for 2 or 3 weeks, that a very significant proportion do development blood clots.

Now, blood clot formation and dysfunction from a blood clot are two separate items. These catheters are also prone - just like the central catheters - to developing fibrin sheaths and small blood clots at their tip, which preclude their ability to be used. And thus, the peripherally inserted central catheters are a target for a compound such as alfimeprase as much as the centrally inserted catheters.

Thank you.

You’re welcome.

There are no further questions at this time. I’d like to turn the conference back to Dr. Ted Love.

In closing, I’d just like to reiterate our confidence and excitement about the progress of our three clinical programs and our continued research progress in our labs. I’d like to say, because I feel very strongly, that Nuvelo has never been stronger as a Company.

Alfimeprase is poised to enter Phase III trials in the very near future. RNAPc2 continues to march through Phase II trials in collaboration with Dr. Eugene Braunwald and his TIMI Group at Harvard Medical School. ARC183 has already begun Phase I testing and proof of concept Phase I trials to demonstrate the rapid titratability of an anticoagulant, which would be as major advance in the context of CABG surgery.

Our research group is highly focused, making great progress internally and with our partner Kirin Pharmaceuticals in Japan. And lastly, our financial resources are sufficient to protect us from short-term market conditions and allow us to focus on achieving milestones, which should significantly drive the value of our Company upward.

I’d like to thank you all for joining us on the call today.

This does conclude today’s conference call. A replay is available starting at 6:30 P.M. CST by dialing (888) 203-1112. Again, that is (888) 203-1112, entering the confirmation code 669122. Again we would like to thank everyone for their participation in today’s conference. That replay is available for two weeks.