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Executives

Cynthia Clayton – Senior Director of IR and Corporate Communications

John Maraganore – CEO

Akshay Vaishnaw – SVP, Clinical Research

Patty Allen – VP of Finance and Treasurer

Barry Greene – President and COO

Analysts

Marko Kozul – ThinkEquity

Ted Tenthoff – Piper Jaffray

Keay Nakae – Chardan Capital

Alan Carr – Needham & Company

Steven Willey – Stifel Nicolaus

Alnylam Pharmaceuticals, Inc. (ALNY) Q3 2010 Results Conference Call November 3, 2010 4:30 PM ET

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Alnylam Pharmaceuticals conference call to discuss the third quarter 2010 activities and financial results.

There will be a question-and-answer session to follow. Please be advised that this call is being taped at the company’s request.

I’d now like to hand the call over to Alnylam.

Cynthia Clayton

Good afternoon. I’m Cynthia Clayton, Senior Director of Investor Relations and Corporate Communications at Alnylam. With me today are John Maraganore, our Chief Executive Officer; Barry Greene, our President and Chief Operating Officer; Akshay Vaishnaw, Senior Vice President, Clinical Research; and Patty Allen, Vice President of Finance and Treasurer. In addition, Laurence Reid, our Chief Business Officer is also on the call and available for Q&A.

For those of you participating via conference call, the slides we have made available via webcast can also be accessed by going to the Investors page of our website, www.alnylam.com.

During today’s call, as outlined on Slide 2, John will provide some introductory remarks and general context, Akshay will summarize our clinical and preclinical R&D activities, Patty will review our financials and guidance, and Barry will summarize our business highlights and goals. We will then open the call for your questions.

Before we begin, as you can see on Slide 3, I would like to remind you that this call will contain remarks concerning Alnylam’s future expectations, plans and prospects which constitute forward-looking statements for the purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those discussed in our most recent quarterly report on file with the SEC. In addition, any forward-looking statement represents our views only as of the date of this recording and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements.

I will now turn the call over to John.

John Maraganore

Thanks, Cynthia. Welcome everyone and thanks for joining us this afternoon. I’ll be referring to slides 4 and 5 during my introductory comments.

As you know, we made some difficult decisions this period related to the transitions in our Novartis partnership after completion of our fifth and final year of this collaborative effort. These decisions were important steps in building our company for the long term which Barry will discuss in more detail momentarily.

But to provide some perspective at the beginning, the corporate restructuring that we effected allows us to transition certain historical service-based resource allocation activities toward a more product-focused and higher-value commitment of effort. And while difficult decisions were made at a personal level, we feel that they will enable us to optimally position our company for continued growth, success and value-creation for the future.

In the meanwhile, we continue to lead the translation of RNAi therapeutics to patients as a whole new class of innovative medicines and we are very confident about the progress we are making across multiple dimensions. In this regard, Alnylam had a very productive third quarter, one in which we continue to make significant progress in advancing RNAi therapeutics through human clinical trials as Akshay will detail for you shortly.

I think it’s very important to keep in mind that progress on our clinical pipeline remains the critical determinant in our company’s value-creation strategy. Rest assured that we are very focused on this activity accordingly.

Importantly, with three RNAi therapeutic programs in clinical development, we continue to be at the forefront of RNAi R&D, indeed we are positioned today more than ever to deliver on this technology’s enormous promise with important human data emerging in the months to come. Notable during the quarter was the initiation of our Phase I study of ALN-TTR01 for the treatment of Transthyretin-mediated amyloidosis or ATTR, our company’s third clinical program.

In addition, we continue to enroll patients in our Phase I study for ALN-VSP for liver cancer and our Phase IIb study for ALN-RSV01 in RSV-infected lung transplantations. We also have a product opt-in right on Tekmira’s PLK-1 program which is in Phase I clinical development in cancer, so we eagerly await progress and success in their efforts. Moreover, we expect to have two or more additional programs in clinical development in the next year which includes our PCSK9 program, our second-generation TTR program, and our anti-miR-122 program for the treatment of HCV infection being advanced with Regulus in collaboration with GlaxoSmithKline.

In short, it’s all about the pipeline and human data. We’re very focused on this overall clinical objective with appropriate urgency and enormous passion.

I’d like to close my introductory remarks on the organization front. In this regard we were very excited to strengthen our management team this past quarter with the promotion of Ken Koblan to Chief Scientific Officer and the appointments of Steve Bossone as Vice President of Intellectual Property and Garvin Warner as Vice President of Preclinical Development. Ken Koblan is an outstanding choice as the company’s CSO. As a reminder, he joined our research group earlier this year from Merck where he played a major leadership role in their drug discovery efforts over an 18-year tenure. Steve Bossone joins Alnylam from Shire and Garvin Warner joins Alnylam from Pfizer. In addition, we also expanded our board of directors with the election of Steve Paul who is the former President of Lilly Research Laboratories of Eli Lilly & Company.

We’re very fortunate to have been able to attract such an outstanding team of management and directors to Alnylam, and the passion that they bring for our company’s mission is shared by all of us here at the company.

With that introduction, I’ll now turn the call over to Akshay for a review of our clinical activities, our pipeline and our scientific progress. Akshay?

Akshay Vaishnaw

Thanks, John, and hello everybody.

As John mentioned, we made important progress during the past quarter across our pipeline and scientific activities. As you can see on Slide 7, we now have three RNAi therapeutics currently actively enrolling in human clinical trials.

Starting with the ALN-TTR01, we initiated a Phase I randomized, placebo-controlled, dose-escalation study of ALN-TTR01 in patients, which is summarized on Slide 8. The primary objective of this study is to evaluate the safety and tolerability of a single dose of intravenous ALN-TTR01 with patients being enrolled into five sequential cohorts of increasing doses ranging from 0.01 to 0.4 milligram per kilogram.

We also believe we have the opportunity to assess preliminary human proof of concept based on measurements of serum TTR level in patient samples. We’re currently actively enrolling in this trial and we’ll update you on potential timing for completion as the study continues to advance.

Turning to ALN-VSP, we continue to make progress in our Phase I multicenter, open-label, dose-escalation trial in patients with liver cancer. The primary endpoint of this study is to evaluate safety, tolerability and pharmacokinetics in patients with advanced solid tumors with liver involvement. This study has not yet reached the maximum tolerated dose and so we’re still continuing to enroll patients in a dose-escalating manner. We’ve also enrolled several patients in a non-company [ph] extension study where patients who have completed four months of dosing and achieved designation of at least stable disease remained eligible to continue receiving ALN-VSP.

All this progress is very encouraging indeed and we’ll be presenting – it’s very encouraging indeed and we’ll be presenting additional interim data from the study next week at the Chemotherapy Foundation Symposium being held November 9th through 13th in New York City.

We also continue to make progress with our Phase IIb study of ALN-RSV01 in RSV-infected adult lung transplantations. This study is progressing well and has enrolled double-digit numbers of patients. We’re just entering the northern hemisphere of RSV season and expect to be able to provide greater clarity on timing for completion as the season progresses.

We continue to be encouraged by the progress we’ve made in preclinical programs which are outlined on Slide 10. In the case of our PCSK9 program, we’re on track for a 2011 R&D filing and believe that RNAi therapeutics targeting PCSK9 in contrast to monoclonal antibodies represent the optimal strategy to silence both intracellular and extracellular PCSK9 levels, thereby phenotyping [ph] the human genetics where loss of function PCSK9 mutations have been associated with low LDL cholesterol levels and protection from coronary artery disease.

Regarding our Huntington’s disease program, we’re pleased to announce this morning that we formed a new collaboration with Medtronic and the CHDI Foundation to advance this effort. CHDI brings a tremendous amount of disease expertise that will prove invaluable to the advancement of this program towards the clinic. CHDI also brings an important connection to patients where we have a commitment to advance such an important disease-modifying therapy. In this new agreement, CHDI will initially fund approximately 50% of the program’s R&D enabling activities, representing more than $10 million in funding.

Beyond our development pipeline, we’ve also made significant advancements to the delivery of RNAi therapeutics. By all accounts, our progress on delivery this past year has been astounding. For example, we present a new research on the discovery of a new lipid called MC3 that has been formulated with siRNA into novel LNP that achieve effective in vivo that achieve effective in vivo gene silencing activity at single-digit microgram per kilogram dose levels. This systemic delivery performance is the best in the industry by far, highlighting Alnylam’s continued leadership and establishing a new benchmark.

In addition, we’re achieving delivery beyond the liver. For example, we reported on data showing target gene silencing with novel LNPs in both immune cells and also in the vascular endothelium. Moreover, just earlier this week at the Liver Meeting, we presented new data on novel LNPs that effectively deliver siRNAs in hepatic stellate cells which are intimately involved in fibrotic pathophysiology. In aggregate, the key point here is that RNAi delivery is evolving with broad-based potential where we can target a very large number of disease genes in multiple tissues and cell types.

Lastly, we continue to demonstrate our scientific leadership through the publication of our research in peer-reviewed journals and presentations of our research at scientific meetings. As you can see on Slide 11, we’ve now published 31 peer-reviewed papers this year, well exceeding our goal of 15 or more by the year’s end, and marking the largest number of peer-reviewed papers that our scientists have ever published in a single year by far. We certainly congratulate our scientists on their continued innovation which is the heart of our business.

And with that, I’d like to turn the call over now to Patty for a review of our financials. Patty.

Patty Allen

Thanks, Akshay, and good afternoon everyone. Please refer to Slide 13 in our deck.

I am happy to report that we continue to maintain a very strong financial profile. At the end of the third quarter, Alnylam had cash, cash equivalent and marketable securities of $271.9 million. Our net cash position is in the top 10 across the entire biotech industry and therefore provides us with significant financial flexibility and a runway of several years to come. It also continues to enable us to invest prudently in our preclinical and clinical pipeline, our efforts in delivery, and the overall scientific platform. Importantly, we also continue to have no write-offs related to our cash and fixed income portfolio to date.

We recorded very strong GAAP revenues of $27.7 million in the third quarter of 2010. As you know, the continued amortization of upfront payment from the strategic alliances we have formed with Roche and Takeda account for a significant and recurring portion of our quarter GAAP revenues.

Our revenues this quarter were higher than previous quarters due primarily to significant resource allocation to the Novartis collaboration which totaled $4 million for Q3 and certain milestones from licenses including Quark. We expect future revenue from current partners to be closer to levels just prior to the Takeda alliance. We will continue to report quarterly GAAP revenues primarily from our alliances with Roche, Takeda, Cubist and other ongoing alliances.

Moving to expenses, I will once again compare our results from this quarter to Q2 of this year which I believe is a more informative way of comparing our financial results. R&D expenses were $27.5 million in the third quarter of 2010 as compared to $28.1 million in the second quarter of 2010. The decrease in R&D expenses in the third quarter is due primarily to the timing of costs related to manufacturing which can be lumpy from quarter to quarter. The decrease in R&D expenses was partially offset by a restructuring charge of approximately $1.9 million related to employee sovereign benefits and related costs incurred in connection with our corporate restructuring which included a workforce reduction.

G&A expenses were $8.9 million in the third quarter of 2010 as compared to $10.1 million in the second quarter of 2010. The decrease in G&A expenses through the third quarter was due primarily to a reduction in professional service fees in association with business activities, primarily legal fees related to our litigation. We expect to see our G&A expenses also continue to be a bit lumpy from quarter to quarter until the precise timing of the trial related to our ongoing litigation is known.

With respect to guidance for 2010, we continue to expect our cash position at the end of 2010 will be greater than $325 million.

And lastly, I will point out that we received notification earlier this week that all eight of our applications for the Therapeutic Discovery Project tax grant with the federal government were awarded, resulting in nearly $2 million of cash grants to Alnylam this year. In addition, Regulus was also awarded two grants totaling approximately $500,000 which will support preclinical development of their micro-RNAi therapeutic approaches to treat HCV infection and fibrosis. So in aggregate, Alnylam and Regulus received maximum funding for our application, totaling approximately $2.5 million.

This concludes the financial highlights and I’ll now turn the call over to Barry.

Barry Greene

Thanks, Patty, and hello everyone.

As John mentioned, we had an important quarter on the business front as you can see on Slide 15. Notably, Novartis notified us that they affirmatively selected their full and final list of 31 specific gene targets for which they have exclusive rights to discover, develop and commercialize RNAi therapeutics using our intellectual property and technology. Novartis has been very clear to us that they intend to diligently advance their RNAi efforts on these targets using Alnylam IP and technology, and we certainly wish them well in these efforts.

In return, we’re eligible to receive $75 million in milestone payments for every successful developed product, resulting in greater than $2 billion in potential aggregate future payments in addition to royalties on product sales.

Also, as we previously announced, Novartis notified us of their decision to decline their option for adoption license to gain broader non-exclusive access to Alnylam’s fundamental and chemistry IP. Although we certainly hope to benefit financial in this option for broader license, the completion of our Novartis alliance now allows us to transition our activities away from service-based research activities such as the historically resource allocation of research services to Novartis. Further, we now have significantly greater degrees of freedom as it relates to future partnerships that we will form and where we have multiple active discussions.

To effect the needed changes, we fully implemented and completed a corporate restructuring with an approximately 25% reduction in our overall workforce. This restructuring will enable us to optimally position our company for continued growth, success and focused on the highest value activities such as the advancement of our own pipeline, as John and Akshay reviewed. It goes without saying that we are extremely grateful to our people, both past and present, for their dedication, passion and commitment in advancing RNAi therapeutics to patients.

Also during the period, we announced that Sanofi-Aventis, as part of their alliance with Regulus, completed their $10 million equity investment in return for approximately 9% equity ownership position in Regulus. The investment by Sanofi continues to strengthen Regulus’ balance sheet, and as a result, Sanofi becomes the third largest investor in Regulus behind Alnylam and Isis.

Importantly, Sanofi stock purchase values Regulus at a greater than $130 million post money valuation and marks 100% premium to the Series A investment Alnylam and Isis made in Regulus just in 2009. Clearly we’re building significant value in Regulus and the business development success of the Regulus team is allowing us to maintain a very high level of ownership in the world’s leading micro-RNAi therapeutics company without further need for investment from Alnylam in the foreseeable future.

Lastly, as illustrated on Slide 16, we continue to strengthen our intellectual property position during the third quarter through the issuance or grant of new patents worldwide which are listed today in our press release, It goes without saying that our IP saved [ph] remains dominant in the field of RNAi therapeutics.

So, reviewing our goals from now through around mid-2011 which you can see on Slide 17. We expect to have four RNAi therapeutic programs in clinical development and advance our preclinical RNAi and micro-RNAi therapeutic programs including both proprietary pipeline programs and partnership-based programs; continue advancing and developing novel delivery solutions for the systemic delivery of RNAi therapeutics; form additional new alliances across our efforts at Alnylam, Regulus, Alnylam Biotherapeutics and through formation of new ventures, all of which will provide near-term potential value creation. And we also expect to further strengthen our scientific leadership and intellectual property solution. And lastly, we fully expect to finish 2010 with greater than 325 million in cash.

With that, I’d like to turn the call back over to the operator for your questions. Operator, [Jonathan], we’ll take questions now.

Question-and-Answer Session

Operator

(Operator Instructions)

Your first question comes from the line of Marko Kozul with ThinkEquity. Please proceed.

Marko Kozul – ThinkEquity

Hi, good afternoon and congratulations on your progress during the quarter.

John Maraganore

Thanks, Marko.

Marko Kozul – ThinkEquity

The question I have concerns Biotherapeutics. Can you give us a preview for the next sets of data presentations in terms of timing and possibly significance to potential commercial applications?

John Maraganore

Yes, happy to do so, and Barry can – also has some additional colors as Laurence Reid who’s here with us can do as well.

The Alnylam Biotherapeutics effort is, as you know, is an exciting effort that we initiated about a year or so ago focused on using all the advances in delivery that we’ve engineered with human applications of RNAi therapeutics for applications in manufacturing of biologics. And the progress there has been actually very encouraging. We’ve now shown that we can scale the technology up to 40-liter scale, we’ve applied it to a bona fide manufacturing cell lines and Chinese hamster ovary cells, and we’re applying it to other applications as well that we haven’t yet discussed with the outside world but will.

There’s been a number of scientific presentations that have been made by our scientists in meetings. We’ll obviously continue to update people as new and important new data come out from those efforts. We have a lot of discussions going on across the biotech industry with manufacturers of biologics who are very interested in using this technology. And all I can say right now, Marko, is really stay tuned as all those discussions materialize into what we expect to be a significant number of agreements over time.

Laurence or Barry, if you want to make any further comments.

Barry Greene

John, I think you just summarized it well. The only thing I’d add is, to add some color, is virtually all biologics manufacturers when seeing scientific presentations have called to get updates, and we’re having very many, very good robust discussions. As the data and the partnerships emerge, we’ll certainly fill you in in the future. We fully expect that to occur.

John Maraganore

Good. Any other questions on that, Marko?

Marko Kozul – ThinkEquity

No, that’s perfect. Thanks. I’ll jump back in queue. Thank you.

John Maraganore

It’s getting a lot of traction is the bottom line.

Operator

Your next question comes from the line of Ted Tenthoff with Piper Jaffray. Please proceed, sir.

Ted Tenthoff – Piper Jaffray

Great, thanks very much. Nice to hear your guys’ voice, and congrats on the quarter. Two quick updates. I had heard ramblings that there may be preliminary parts of the hearing this week. Is there anything scheduled for this week?

John Maraganore

Well, there is a hearing, and this is public information, there’s a hearing on a number of different motions that had been brought forward before the court on Friday this week and there’s not much we could comment on in terms of that other than what’s publicly available which you can take a look at. But these are motions that had been made by both UMass-Whitehead and Alnylam-Max Planck in the different matters related to the case.

Ted Tenthoff – Piper Jaffray

But this isn’t any final decisions or anything like that?

John Maraganore

No. No, these are the judge hearing specific motions that had been brought forward by the related parties.

Ted Tenthoff – Piper Jaffray

And not to dwell on this, but if you could just real quickly remind us what the hearing is about and what the goal is here. Are you guys basically suing Max Planck to try to accelerate the prosecution of Tuschl I, is that a fair way to characterize it or –?

John Maraganore

We’re co-plaintiffs with Max Planck, so we’re not suing Max Planck. Max Planck and Alnylam have joined in a suit against Whitehead and University of Massachusetts related to the, at the end of the day, related to the use of data from Tuschl II in the prosecution of the Tuschl I application, and disagreement as it relates to that path forward. And that’s about all I could really say on that, Ted, given that it’s a matter of litigation.

Ted Tenthoff – Piper Jaffray

That’s very helpful, John. One more on that data coming next week on VSP, I think from spending some time with Akshay and the guys at Unc in Chicago, I think the next dose that you guys are going to was 1 mg per kg. So when we get patients on that, and also I think I had written a note down that we might get liver biopsy data which I think would be very interesting, so when we get, can you tell us a little bit more about what to expect next week?

John Maraganore

Yes. Akshay, you want to handle that.

Akshay Vaishnaw

Hey, Ted. So we’re excited about this presentation next week, I think it’s a great opportunity for us to update everybody on the progress we’ve made towards further dose escalation from that ASCO data [ph] in June where as you said we haven’t hit 1.0 mg per kg, and we have indeed gone there and beyond, and we’ll be updating folks next week on that, the safety data associated with that.

And I don’t want to preempt, but I think it definitely is worthwhile updating folks at this stage, we have, as you said, also been conducting biopsies. And as those data come together, we’ll also be sharing that with folks on the outside. But definitely it’s a significant update and we’ve gone to the dose level you indicated and beyond, and you’ll be seeing a lot of data associated with that.

John Maraganore

Yes, and I think just to add to that a little bit, Ted, I think the key thing is that we’re now getting – we now have the most extensive experience with systemic delivery of RNAi therapeutics using lipid nanoparticles that is by far, both in terms of numbers of patients and numbers of doses that have been administered to these patients, a very extensive experience. And it provides critically important de-risking for our entire pipeline of systemic RNAi, and that’s a big, big step forward. So you’ll hear more about that next week. I don’t want to preempt the actual results that will be shared, but I hope you’ll be able to attend or at least see the release as it comes out.

Ted Tenthoff – Piper Jaffray

I look forward to it too and TTR data next year. So thanks so much for the update guys.

John Maraganore

You’re here.

Operator

(Operator Instructions)

Your next question comes from the line of Keay Nakae from Chardan Capital. Please proceed.

Keay Nakae – Chardan Capital

Yes, thank you. Barry, just to follow up on your comments, once we see the data next week, what’s your anticipated timeline for completing the study?

John Maraganore

Yes. This is John. Maybe Akshay should comment on that.

Akshay Vaishnaw

So next week’s update, and I think is an important one, outlining the safety at significant dose levels, and as John discussed, we’re very excited about the progress we’ve made and continue to make. The dose escalation is ongoing. You’ll see the status next week how far we’ve gone, and with dose escalation continuing, I think that’s great news, and it’s wrong at this time to forecast the end of the study. Clearly we have estimates forming, but until we actually top out on the maximum tolerated dose, and it’s great news that we haven’t as yet, it’s wrong to preempt that. But I think as we hit a maximum tolerated dose, we’ll certainly be able to give more accurate guidance on when that study completes.

John Maraganore

Yes. Thank you, Akshay.

Keay Nakae – Chardan Capital

Okay, thanks for that. And then with respect to Huntington, we saw today’s announcement, how does that affect the amount of R&D spending you might incur?

John Maraganore

It certainly decreases it. I mean CHDI is basically funding 50% of the overall development expenses for the Huntington’s disease program all the way through the R&D filing. And that’s a very significant investment they’re making in the program.

They’re an incredibly committed group of patient advocates, physician scientists that really looked at the Alnylam Medtronic program and we believe appropriately recognized it as being one of the most exciting programs for potential breakthrough therapies for this obviously devastating neurodegenerative disease. So their commitment and what they bring to the table beyond the funding is obviously quite significant for the company, and we’re pleased to have their support. But obviously that helps offset the costs of that program in a significant manner.

Keay Nakae – Chardan Capital

And at what stage do they get involved with providing capital? Does that happen right away or –?

John Maraganore

Yes, Patty, you want to comment on that?

Patty Allen

Yes. Right now the program we entered into with them say we’ll pay for the costs from the beginning of this year up through IND.

John Maraganore

So it’s actually retroactive.

Patty Allen

Yes. And as we said in the release today, it’ll be greater than $10 million. And if you recall, we’re 50/50 with Medtronic on this program.

Keay Nakae – Chardan Capital

Right, okay. Well, very good. Thanks for that.

John Maraganore

Yes.

Operator

Your next question comes from the line of Mr. Alan Carr with Needham & Company. Please proceed, sir.

Alan Carr – Needham & Company

Hi, good afternoon, thanks for taking my question, and congratulations on your progress.

John Maraganore

We appreciate that.

Alan Carr – Needham & Company

Question around, let’s see, the clinical pipeline. It looks to me like PCS is the next one to get into the clinic then.

John Maraganore

Yes, should be.

Alan Carr – Needham & Company

And then ATT after that, is that right?

John Maraganore

Well, did you say ATT? I think that what we’re saying right now as we look at next year, the programs PCSK9, the second-generation TTR program that uses our second-generation LNPs and potentially the anti-miR-122 for HCV infection are the three programs from which we expect to have two or more INDs next year. The Huntington’s program is likely to be a 2012 IND filing.

Alan Carr – Needham & Company

Okay. And I was wondering, you’ve made some progress, you mentioned, with MC3, this new lipid systemic delivery system. I wonder if you could tell me about how that might work its way into some of your candidates and timing for that getting into the clinic.

John Maraganore

Well, I mean Akshay can comment further, but it’s being used in our PCSK9 program at the get-go, right? So that’s the new lipid LNP formulation that’s achieved remarkably improved potencies and just beautiful [ph] over [ph] biological activity, including results in rodents and non-human primates. Akshay –

Akshay Vaishnaw

Nothing to add to that. It’s obviously a very exciting second-generation LNP. And with the approved potency and the lower exposures, so that’s all great to put into development in a number of programs beginning with PCSK9.

Alan Carr – Needham & Company

Last one, Patty, with guidance for 2010, you said greater than 325 which is a big decline from your around 375 now I think it was. Is there – are you just being extremely conservative there or is there a chance that you might have expenses actually – I mean there would be a big ramp-up for the fourth quarter?

Patty Allen

Right. So what we’ve said, Alan, from the beginning of the year is that we will have a number of greater than $325 million in cash at the end of 2010. We still feel that’s appropriate and that it will be greater than that number.

John Maraganore

Yes, but we’re not expecting any unusual change in our expense profile from now through the fourth quarter.

Patty Allen

Right.

Alan Carr – Needham & Company

Okay. And then –

John Maraganore

But we didn’t feel it was appropriate to change guidance at this point in time given that we’re still within guidance in terms of greater than 325.

Alan Carr – Needham & Company

I see. And then for 2011, can we expect any substantial deviations from the trends that we’ve seen through 2010?

Patty Allen

No. We’ll provide guidance in the beginning of January as we do every year for what our cash guidance will be for the end of 2011, but we wouldn’t expect any significant deviation. We did do a restructuring, so we have said that we will have some lower costs in 2011, but the pipeline progresses.

Alan Carr – Needham & Company

Okay, great. Thanks for taking my questions.

John Maraganore

Sure, Alan. Thank you.

Operator

And the final question in queue is Steven Willey with Stifel Nicolaus. Please proceed, sir.

Steven Willey – Stifel Nicolaus

Hi. Thanks for taking my questions.

John Maraganore

Sure. Thanks, Steve.

Steven Willey – Stifel Nicolaus

On the VSP front, I know that you had mentioned I think in your comments that you have not observed the DLT to date. So I guess knowing that and knowing that you seem to be well above the 1 mg per kg, how high do you continue to push that dose? And is that something that you gleaned from the biopsy data that comes in as to whether or not you’re saturating those complexes I guess with RNAi?

John Maraganore

Great question. Akshay, you want to handle that?

Akshay Vaishnaw

It’s a great question. And the biopsy, as we get all the data together, Steve, you’re actually right, it’s going to be very important in helping us estimate drug delivery and biodistribution to the target organ, in this case the liver. So that’s to come yet, but the most important thing in this kind of stuff is to keep escalating the dose until safety precludes, and the great news so far is you’ll see in more data presented next, is that we continue to dose escalate. The Protocol 3 specifies a top dose of 1.7 milligram per kilogram, and we haven’t hit that yet. And implicit in that is that safety has been going well, as you’ll see. So we’re very excited by just how far we’ve come with this program and look forward to sharing the data.

John Maraganore

And again, Steve, I think the important thing is just the significant level of experience now that we’re generating in man with this platform in that trial is very substantial and I think it’s going to – it’s obviously not just relevant for the liver cancer program that’s very, very important to us, but also the advancement of other systemic delivery programs like TTR01, PCSK9 and other programs in the future.

Steven Willey – Stifel Nicolaus

And then just a question on the delivery front, I know that you showed some preclinical data at the Liver Meeting over the weekend with respect to a carbohydrate-based formulation. And I think you made some comments before about how you’re, I don’t want to say married, to the LNP front, but that was kind of your bread and butter, for lack of a better term. And I guess just given the fact that [Audio Gap] are thinking more about internally?

John Maraganore

Well, we’ve always had a very active program on the conjugate effort, and the carbohydrate that you’re referring to relates to the use of small molecule carbohydrate ligands that are directly conjugated to siRNAs for delivery. We made actually this past year some pretty encouraging progress on that whole delivery strategy.

So across our delivery efforts, it’s really the work on LNPs and the work we’re doing on conjugates that really defines our two leading systemic delivery approaches. Right? And so the update at the Liver Meeting on the Galmet [ph] conjugates which is this carbohydrate attachment is what you’re referring to. And we’re pretty excited about those data; we’re hoping to update people in the months to come on some important progress on that front.

Steven Willey – Stifel Nicolaus

And then just lastly on the IP, and not to beat it into the ground, but just wondering I guess what the ultimate objective of the proceedings is. Is it to actually get those mammalian claims I guess that were issued in Tuschl I out of Tuschl I and –?

John Maraganore

Yes, it’s to rightfully have the data of that – that come from Tuschl II rightfully removed from Tuschl I.

Steven Willey – Stifel Nicolaus

Okay. Thanks for the explanation.

John Maraganore

Yes. Thank you.

Good. Operator?

Operator

At this time there are no further questions.

John Maraganore

Okay, good. Well, thanks everyone.

We made a lot of important progress this past quarter. We’re positioned to continue to focus on building a significant company here based on RNAi therapeutics, and we’re excited about our progress, and we look forward to updating you in the weeks to come and the months to come. So, thank you very much. Bye-bye now.

Operator

Ladies and gentlemen, thank you for your participation in today’s call. The presentation has ended. You may now disconnect. Have a good day.

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