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Astex Pharmaceuticals (NASDAQ:ASTX)

Q1 2013 Earnings Call

April 29, 2013 4:30 pm ET

Executives

Timothy L. Enns - Senior Vice President of Investor Relations, Business Development & Corporate Communications

James S. J. Manuso - Chairman and Chief Executive Officer

Mohammad Azab - Chief Medical Officer

Harren Jhoti - Co-Founder, Chief Executive Officer and Director

Martin Buckland - Chief Business Officer and Director

Michael Molkentin - Chief Financial Officer, Principal Accounting Officer and Corporate Secretary

Analysts

Michael J. Yee - RBC Capital Markets, LLC, Research Division

Michael G. King - JMP Securities LLC, Research Division

Jason Zhang - Edison Investment Research Limited

Boris Peaker - Rodman & Renshaw, LLC, Research Division

Operator

Good day, ladies and gentlemen, welcome to the Astex Pharmaceuticals Q1 2013 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the call over to Timothy Enns, Senior Vice President, Corporate Communications and Marketing. Please begin.

Timothy L. Enns

Thank you, operator. Good day, and thank you for joining us for Astex Pharmaceuticals 2013 First Quarter Financial Results Conference Call. With me today are Dr. James Manuso, Chairman and Chief Executive Officer; Dr. Harren Jhoti, President and Director; Dr. Mohammad Azab, Chief Medical Officer; Dr. Martin Buckland, Chief Business Officer; and Michael Molkentin, Chief Financial Officer.

In a few moments, our officer team will deliver remarks on the 2013 first quarter financial results and our business outlook for the year. After prepared comments, we will open the line for questions. Earlier today, we issued a press release with our financial results. A copy of the press release is available in the Investor Relations section of our website at www.astx.com. In addition, this call is being webcast and may be accessed via the Investor Relations section of our website. A webcast replay will be available for 30 days.

During this call, we will make projections and forward-looking statements that are based on management's current expectations. Actual results may differ materially from these forecasts and projections due to various factors. There are significant risks and uncertainty in biotechnology research and development. There can be no guarantee that our projects, products or product candidates will progress preclinically or clinically as we expect, or that we will ultimately obtain approvals for the indications that we seek. Moreover, even if our products or product candidates are approved in the future, we cannot guarantee they will be commercially successful.

The company's results may also be affected by a variety of factors, such as competitive developments, launches of new products, the timing of anticipated regulatory approvals or regulatory action, the actions of our strategic partners and collaborators with respect to the products we license or codevelop, and patent disputes and litigation.

For additional information and discussion concerning the risk factors that affect the company's business, please refer to the company's filings with the Securities and Exchange Commission. The company undertakes no duty to update forward-looking statements.

In the coming weeks, we'll be participating in the following investor conferences. Tomorrow, April 30, in New York City, the Needham Healthcare Conference; in June, the Jefferies Healthcare Conference; and in July, the JMP Securities Healthcare Conference. Additionally, we will be holding our annual meeting of stockholders on June 13, at our headquarters in Dublin, California. Information on these events can be found in the Investor Relations section of our website. I'll now turn the call over to Dr. James Manuso, who'll provide highlights of our accomplishments during the 2013 first quarter. Jim?

James S. J. Manuso

Thank you, Tim. Good afternoon and thank you for joining the Astex Pharmaceuticals 2013 First Quarter Conference Call. I'm very pleased to report that Astex has had a successful first quarter on multiple fronts. Patient accrual in our Phase II programs progressed very well. Preclinical data supporting our expanded clinical trial programs and our partners' clinical program data were received positively at the AACR Meeting.

On the revenue side, Dacogen royalty has continued to grow at a nice pace. In some, the first quarter's performance has been a great way to start a very exciting year for our company. Our progress has been appropriately recognized by Wall Street. During the first quarter, senior biotechnology analysts from 2 banks, JMP Securities and RBC, initiated new coverage on Astex. Our sell side coverage now consists of 3 bank analysts and one independent analyst. This additional interest and exposure has helped to raise our valuation to a point where larger growth-oriented funds can evaluate, follow and, potentially, benefit financially from our progress.

In the first quarter, Dacogen royalty revenues increased over 7% to $22.1 million compared to the same prior year period. And we reported net income of $488,000. Our cash and equivalents position remains strong. We ended the quarter with $137 million. Janssen, the Dacogen sub-licensee outside of North America, continues to register Dacogen for sales, marketing and reimbursement in the individual European Union countries and elsewhere for the treatment of patients aged 65 years and above, with newly diagnosed de novo, or secondary acute myeloid leukemia, or AML, who are not suitable for induction chemotherapy. The Dacogen European market is protected by a 10-year orphan drug designation that was granted at the time of the product's approval. Recall also that the AML population in the E.U. is 18,000 patients, 10,000 of whom are elderly.

It was not that long ago that no one knew what hypomethylators were, but last year, in 2012, global sales of the 2 marketed hypomethylators, Dacogen and Vidaza, exceeded $1.1 billion. Astex will continue to participate in this important worldwide market despite the anticipated expiration of Dacogen's orphan drug designation in the United States, next month. As a reminder, separate and apart from Dacogen's approval in elderly AML in the E.U., Janssen has obtain marketing approval for this important medicine in the myelodysplastic syndromes, or MDS, indication in over 35 countries. Astex will continue to receive escalating royalties at rates from 20% to 30% on all net sales of the drug worldwide, regardless of indication and irrespective of which of our partners, Eisai in North America or Janssen in the rest of the world, makes the sale.

In a few moments, I will turn the call over to our officers so they can update you on our important programs and initiatives. Our Chief Medical Officer, Dr. Mohammad Azab, will update you on our 2 prioritized clinical programs, SGI-110 and AT13387.

Our President, Dr. Harren Jhoti, will then discuss Astex's innovative epigenetics partnerships with Cancer Research Technology Ltd., or the CRT, and the Institute of Cancer Research, or the ICR, in London, and the discovery collaboration with CRT and Newcastle University.

Our Chief Business Officer, Dr. Martin Buckland, will provide an update on our partnered programs with major pharmaceutical companies, under which, 4 novel drugs are being tested in the clinic. Taken together, our partnered programs have the potential to generate for our company more than $800 million of milestone payments, plus eventual royalties on sales.

Lastly, before I make a few final comments, our Chief Financial Officer, Michael Molkentin, will review our 2013 first quarter financial results and outline our guidance for the remainder of the year.

Let's now begin with an update on our clinical programs by Dr. Mohammad Azab. Mohammad?

Mohammad Azab

Thank you, Jim. And good afternoon, everybody. The Astex 2 prioritized pipeline products, the SGI-110 and AT13387, continue to progress steadily in 6 clinical trials. As you know, SGI-110 is a low-volume subcutaneous, hypomethylating agent, and the Phase II dose expansion stage and the MDS and AML trial continues to accrue steadily. Following the presentation of the Phase I dose escalation data at the ASH meeting last December, we have reported clinical [ph] responses, differentiated sustained exposure to decitabine from SGI-110 and potent demethylation data, which was presented at the ASH meeting and demonstrated that SGI-110 can achieve responses in heavily pretreated MDS and AML patients, including those who are previously treated with Dacogen or Vidaza. SGI-110 has progressed into the dose expansion phase, which is structured in 4 patient cohorts and randomized to either the biologically effective dose or the maximum dose that was well tolerated in both MDS and AML patients using the daily times 5 regimen. These 4 patient cohorts are: the first line MDS patients, relapsed/refractory MDS, first line elderly AML patients not suitable for induction chemotherapy, and the relapsed/refractory AML patients.

There's also a fifth nonrandomized cohort of relapsed/refractory AML who are treated with a more intense regimen as studying the biological effective dose with the daily x 10 schedule. We're now over the 50% accrued in the Phase II dose expansion stage in the MDS and AML trial, and we are on track to complete overall patient accrual for this trial of approximately 200 patients and also report on the first cohort, which completed accrual of the relapsed/refractory AML patients by year end.

Also by year end, the Astex expects to select one or more disease indications to progress SGI-110 into the pivotal Phase III stage. Preclinical data was presented during several presentations at the American Association of Cancer Research meeting, or AACR. The data reconfirmed that potent demethylating activity of SGI-110 in different tumor models and supported the potential of SGI-110 in the treatment of platinum-resistant ovarian cancer, and also as an immune modulatory agent. Phase II studies in platinum-resistant ovarian cancer and hepatocellular cancer are both actively recruiting patients with initial data presentations expected in 2014.

Astex's other prioritized clinical program is the HSP90 inhibitor, AT13387. At AACR, there was preclinical data presented supporting the rationale for studying this agent in our randomized Phase II trial in castration-resistant prostate cancer patients. Preliminary data from both the prostate and the ALK-positive lung cancer trials of AT13387 should be available for scientific presentations next year. Both trials are examining the benefit of AT13387 both as a single agent and also in combination. The prostate trial combines AT13387 with abiraterone acetate, while in the ALK-positive lung cancer trial, the agent is combined with crizotinib. Achievement of safety of the combination and confirmation of the biological activity in terms of down-regulation of the target client proteins for HSP90 inhibition will guide the expansion into the randomized Phase II part for both the castration-resistant prostate cancer and the ALK-positive lung cancer trials.

I will now like to turn the call over to Dr. Harren Jhoti, who will provide an update on our discovery partnerships. Harren?

Harren Jhoti

Thank you, Mohammad. In the latter half of 2012, Astex initiated 2 new drug discovery collaborations with prestigious academic U.K. institutions. In the third quarter of last year, Astex began a partnership with Cancer Research Technology, or CRT, and the Institute of Cancer Research, or ICR, based in London, to discover and develop drug candidates against the multiple myeloma SET domain, or MMSET, an exciting new epigenetic target indicated in blood cancer.

A chromosome translocation of the MMSET gene is linked to disease etiology in multiple myeloma, resulting in overexpression of MMSET in patients. The basis of the collaboration is to combine Astex's world-renowned, fragment-based drug discovery platform, Pyramid, with ICR's expertise in blood cancer biology, as well as their proven success in drug discovery. This collaboration is proceeding well and builds upon a productive partnership from 2003, under which, 2 compounds, AZD5363 and AT13148, that target the key tumor cell survival pathway kinase, PKB/Akt, were discovered, and which have been advanced into clinical trials by AstraZeneca and Cancer Research U.K., respectively.

Astex also began a 5-year strategic drug discovery alliance late last year with CRT and the University of Newcastle. The partners will discover and develop new cancer drugs in collaboration with researchers at the Cancer Research U.K. Drug Discovery Program at the Northern Institute of Cancer Research, or NICR, based in Newcastle University. Within the collaboration, Astex will provide funding, annually, to the university to support research across biology, chemistry, pharmacology and imaging at the NICR, to identify and develop new cancer drugs and associated biomarkers. Astex has an exclusive option to license any of the drug candidates being developed in the NICR portfolio.

This partnership follows a prior collaboration between Astex, Newcastle and CRT, on Fibroblast Growth Factor Receptor, or FGFR, a key cancer target, which led to the discovery and development of the clinical candidate that was subsequently licensed to the Johnson & Johnson company, Janssen. JNJ42756493 is currently being progressed in Phase I clinical trials by Janssen.

I will now turn the call over to our Chief Business Officer, Dr. Martin Buckland, who will discuss our clinical stage partner programs, including LEE011, AZD5363 and JNJ493. Martin?

Martin Buckland

Thank you, Harren. Harren has described some of the new collaborations which use Astex's Pyramid fragment-based drug discovery platform. Astex's historic partnerships with academic centers of excellence, such as the ICR and the NICR, and with large pharmaceutical companies, have already produced an exciting portfolio of novel drugs, including 5 that are now being tested in the clinic.

At the recent AACR meeting, in a late breaking oral symposium, our partner, AstraZeneca, discussed results of 2 Phase I multi-center trials of AZD5363, an inhibitor of a key enzyme in the mTOR/PI3K/AKT tumor cell survival pathway, in which safety, tolerability, preliminary efficacy and biomarker data in patients with advanced solid tumors was presented. Partial responses were observed in 2 patients with mutations in the PI3K/AKT signaling pathway. AZD5363, an orally bioavailable, selective and potent pan-AKT inhibitor is currently being tested in 4 Phase I clinical studies, including estrogen-receptor positive breast cancer and in prostate cancer. The AKT pathway is an important mechanism by which tumor cells evade killing by many commonly used anticancer agents.

Additionally at AACR, our partner, Novartis, presented data on LEE011, an orally active selective inhibitor of 2 key cell cycle kinases, CDK4 and CDK6, showing potent activity in a definable subset of human neuroblastoma cells lines. LEE011 is currently being evaluated in 5 Phase I and Phase I/II studies, including in combination with a number of Novartis priority pipeline drugs. Most recently, the FDA granted breakthrough designation status to another CDK4, CDK6 inhibitor, now advancing in the clinic.

In a different therapeutic area, AstraZeneca has advanced AZD3293, a beta-secretase inhibitor in 2 Phase I studies. A single ascending dose study in volunteers and an ascending multiple dose study in volunteers and Alzheimer's patients. Beta-secretase, also called BACE 1, or beta-site of amyloid precursor protein enzyme, is an aspartic acid protease important in the formation of myelin sheets in peripheral nerve cells and is implicated in the pathogenesis of Alzheimer's disease. Inhibitors which brought the action of this enzyme could help to prevent the buildup of beta amyloid, which may help slow the progression of, or stop the disease.

In partnership with Janssen, JNJ42756493, or 493, an orally active selective inhibitor of Fibroblast Growth Factor Receptor, or FGFR, is being tested in a Phase I study in advanced refractory cancer or lymphoma patients. 493 was discovered as part of a successful collaboration between the University of Newcastle and Astex, and formed part of the oncology partnership entered into between Astex and Janssen in 2008. Astex stands to earn further milestones and royalties on product sales as all these product progress through the clinic and into the market.

Finally, AT13148, an orally bioavailable inhibitor of AGC kinases, including PKB/Akt, PKA, ROCK and p70S6 kinase, was discovered as part of an academic partnership with ICR and Astex. AT13148 is currently being tested in a Phase I clinical study being conducted by Cancer Research U.K. as part of their clinical development partnerships program. New data on the compound was also presented at the recent AACR meeting. AT13148 is wholly owned by Astex.

In regards to our discovery partnership with GlaxoSmithKline, or GSK, Astex continues to make good progress with GBP 9.2 million in research-based milestones earned to date since the start of the collaboration. This partnership applies Astex's Pyramid platform to targets of interest to GSK in multiple therapeutic areas.

At this time, I'll turn the call over to our Chief Financial Officer, Michael Molkentin. Michael will provide details on our 2013 first quarter financial results. Michael?

Michael Molkentin

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Thank you, Martin. I will now comment on our 2013 first quarter financial results. Total revenues for the 2013 first quarter were $22.1 million compared with $22 million for the same prior year period. Total revenues for the 2013 first quarter consist entirely of royalty revenue of $22.1 million, compared with royalty revenue of $20.6 million for the same prior year period.

Total operating expenses for the 2013 first quarter were $23.9 million, compared with $20.6 million for the same prior year period. The primary reasons for the increase in total operating expenses for the current year quarter, when compared with the same prior year quarter, are increased research and development cost associated with SGI-110 and AT13387 and an increase in stock-based compensation expense, offset, in part, by lower amortization of intangibles cost and a reduction in general and administrative expenses.

The noncash amortization of intangibles was $1.9 million for the 2013 first quarter, compared with $2.2 million for the same prior year period, while stock-based compensation expense, also a noncash expense, was $1 million for the 2013 first quarter, compared with $765,000 for the same prior year period.

Net income for the 2013 first quarter was $488,000, or $0.01 per basic and diluted share, compared with net income of $4.2 million or $0.05 per basic and $0.04 per diluted share for the same prior year period. Included in the 2013 first quarter net income, is a foreign currency translation loss of $1.3 million, compared to $4,000 for the same prior year period. Also included in net income, is an income tax benefit of $3.8 million, compared with a tax benefit of $2.8 million for the same prior year period. The income tax benefit for the current and prior year first quarter is primarily due to the recognition of tax benefits associated with the amortization of deferred tax liabilities resulting from the acquisition and utilization of a foreign research and development tax credit related to our U.K. subsidiary.

We continue to report a strong financial position. As of March 31, 2013, the company had approximately $137 million in unrestricted cash, cash equivalents and current and non-current marketable securities, compared to approximately $138 million at December 31, 2012.

Reflected in today's news release is the company's financial guidance for 2013, which remains unchanged from our prior guidance. Selected comments on our financial guidance include forecasted annual royalty revenue for 2013 remains unchanged at $55 million for the year. Though we anticipate the potential of earning additional development and license revenue from our partnered programs during 2013, we do not guide to such revenue due to the general uncertainty around, and timing of, milestone achievements and payments.

We continue to forecast that research and development expenses will increase from $60 million, in 2012, to approximately $67 million for 2013. The increase from the prior year reflects the continuing ramp up of the multiple Phase II clinical trials related to our SGI-110 and AT13387 development programs.

The noncash charge for the amortization of intangible assets is anticipated to be approximately $8 million for 2013, while general and administrative expenses are expected to decrease modestly from the prior year to $15 million, and the estimated income tax benefit continues to be forecasted at approximately $5 million for the year.

Considering the impact of the operational initiatives influencing our financial guidance, the forecasted net loss of approximately $30 million for 2013 remains unchanged, but keep in mind that the forecasted net loss does not reflect any anticipated development and license revenue that may result during this period.

Now on cash operating charges for 2013, included in total operating expenses, continue to be estimated at approximately $12 million for the year. This concludes the review of our 2013 first quarter financial results and comments on our annual financial guidance for 2013. I will now turn the call back to Dr. Manuso for closing remarks.

James S. J. Manuso

Thanks very much, Michael. Astex started 2013 with encouraging SGI-110 Phase I data as reported at the ASH meeting. Interest in the SGI-110 data and the Phase II clinical program designs continue to grow. New data from the Phase I trial will be presented at the European Hematology Association meeting this June.

In terms of our revenue base, Dacogen product sales continue to do well in North America and are showing steady progress in the E.U. Financially, we have maintained considerable strength with cash and equivalents of $137 million at our disposal as of the end of the first quarter. Within R&D, our partner discovery programs have successful track records of producing viable, clinical candidates. Our partner funded product pipeline now boasts 5 drugs in Phase I or Phase I/II trials. Our internal prioritized clinical programs are designed to be properly powered to provide clear proof-of-concept data and direct the design of potential Phase III trials.

By year end, we anticipate selection of one or more SGI-110 disease indications for our Phase III clinical trials consistent with our commercialization strategy. We continue to be on track to file one new IND by year and. Finally, remember that Astex owns fully its prioritized medicines and development and virtually all of the others in its portfolio. These ownership positions are supported by more than 300 issued patents and more than 560 pending applications. The Astex's management team and I look forward to updating you on our progress in the months ahead. Dr. Harren Jhoti, Dr. Mohammad Azab, Dr. Martin Buckland, Michael Molketin, Tim Enns and I, are now ready to answer your questions. Operator, we're pleased to take questions at this time.

Question-and-Answer Session

Operator

[Operator Instructions] The first question is from Michael Yee of RBC Capital Markets.

Michael J. Yee - RBC Capital Markets, LLC, Research Division

Question for Mohammad and the team. You said a goal was to pick a pivotal spill [ph]indication by the end of the year. I guess my question is, how can you do that if you don't get all the data from all these different cohorts until 2014? Are you observing activity or observing the ongoing study throughout the year? Is that basically what's going to guide your decision, you're basically looking at the results as you go through the year? And then I have a follow-up.

James S. J. Manuso

Well, Michael, as you know, these are open labeled trials, so although we will have the complete, probably, reasonably mature data from one cohort, which is the relapsed/refractory AML patients, we will have emerging data from the other cohorts because we said we'll hold the whole trial, with complete enrollment, before the end of the year and, hopefully, that would be 2 months before the end of the year. So for -- in that perspective, we will have seen, at least, some early data from the other cohorts as well. Remember the data mainly also is driving the choice of the schedule, because we're testing 2 different schedules, 60 and 90, with a 5-day, and also, there is a third schedule, with a 10-day regimen, which is a more intense regimen, only for the relapsed/refractory AML patients, which is also recruiting well. So hopefully, with the complete data from the relapsed/refractory AML and, at least from the fully enrolled trials, but not the fully mature data from the other cohorts, we'll be able to make the determination about the indication and the schedule. Having said that, the data is not the only driver for the indication as well. As you know, there is other factors in driving the indication which, such as the commercial assessment, the feasibility of the trial, the probability of success, the unmet need and all of that, are being taken into account. And those -- that information is already available to us. Basically we know what are the indications that are most feasible and have the highest unmet need, and that would be and kind of I think I've said that before, certainly, the patients who are in the relapsed/refractory setting or the second line setting, are the patients who are -- reasonably have the highest unmet need in terms of Phase III potential indication.

Michael J. Yee - RBC Capital Markets, LLC, Research Division

Okay. And then a follow-up then is, you're seeing -- you've seen prior response to, obviously, in Phase I and you're going to be looking at this across your Phase II indications. When you look across the landscape, in your experience, how much does response rate correlate with survival, in both relapsed/refractory AML and MDS in frontline settings? You guys obviously spent a lot of years looking at all this and have worked on these drugs. So what can you say that help gives confidence that response rates we're going to see is going to be driving survival?

James S. J. Manuso

Well, I mean -- it certainly is not only response rate, I have to say that, we would also would like to look at the duration of response which is the quality of those responses. The literature has been mixed on the first -- I mean, I can already exclude the second line MDS. There is very little literature, almost none, on second line MDS. And I think that indication should correlate well with survival, even with stable disease only, because -- or hematological improvement, the reason for that, I say that, is that, basically, after failure of Dacogen and Vidaza, there is no other treatment that is being used. There's not even a treatment that is effective, or had been reported to be effective, in second line setting, even as an off-label use. So I think we're pretty confident that if we're seeing any stabilization of the disease and hematological improvement in the second line setting that would be a good indication and, hopefully, would translate into survival, since these patients, on average, the median survival in the second line MDS, after failure, is just about 5 months, so very short. So that's kind of -- on the second line setting for MDS. For relapse AML also, the data are not really that strong in terms of whether there is a correlation or not with response rate. As you know, some of the data from the front line setting, when you look at the frontline data and kind of indications which try to combine with a 7 plus 3, or adding to the 7 plus 3, there has not been a correlation between a high response rate and survival. As you know, for the elderly AML patients, it has been even more controversial since some of the early trials in elderly AML show that, with lower intensity regimen, you get lower response rate, but you have similar survival to more intensive regimen for the elderly patients. The best data actually coming from the front line setting of AML is the Dacogen data, Phase III data. As you have seen in the Dacogen -- Daco16 trial, which was the basis for approval in Europe, Dacogen doubled the response rate from about 8% to 16%, and also showed a 50% improvement in survival. So at least from that trial, which is a large, 485 patient trial, you can see that there was a correlation, apparent correlation, between response rate and survival. And that response rate was not that high. Like as we said, response rate was only 16% but that basically translated into a 50% improvement of survival.

Operator

The next question is from Mike King of JMP Securities.

Michael G. King - JMP Securities LLC, Research Division

Maybe just a follow up on Michael Yee's questions regarding user correlates of outcome. Mohammad, I just want your thoughts a bit on whether the LINE-1 biomarker is a possible guide to better outcome or is that still too nascent to really give us a clear view to outcome?

Mohammad Azab

I think that's a very interesting point, Mike. It is true that we have, not in the -- like in the past, and I was just being -- there was an acute leukemia forum here in San Francisco a couple of weeks ago, and key opinion leaders still talk about the fact that LINE-1 demethylation did not really correlate with responses of survival in the MDS population. And that statement is true, even in our hands, with the Phase I data that we presented at ASH. Having said that, there is very little research that I know of that correlated LINE-1 with activity in AML. And as you know, from our data that was presented at ASH, we have seen, at least from the preliminary Phase I data, a very nice and strong correlation between LINE-1 demethylation and responses in AML. Whether that is enough to consider using LINE-1 as a patient selection strategy, that -- I think that's still to be confirmed by the Phase II expansion data.

Michael G. King - JMP Securities LLC, Research Division

Okay. All right, fair enough. And then just to turn to the AML studies, again, more for point of clarity. With regard to the more intense regimen, I'm just wondering if you -- would that help you understand what regimen you'll take into registration directed studies? In other words, are you deciding on 5 days for 1 population, 10 days for another? Or if 10 days seems to be superior in the relapse/refractory, you would do 10 days for sort of first line?

Mohammad Azab

As you know, the Phase II expansion is 4 different patient cohorts. For 3 of those cohorts, the 10-day regimen is not available, so it would always be a 5-day regimen, and the choice will be between the 60 milligram per meter square, which is the biological effective dose, or the higher dose, which is 90, so that's for the 3 patient cohort. The only exception is the fourth cohort, which is the relapse/refractory AML. And so the answer is, yes, for that. If we choose that indication, it's certainly one of the high-priority indications for us because of the high unmet medical need. In the relapsed/refractory AML, we have to make the determination, not just between 60 and 95 days, but also between those 2 regimens and the 10-day intense regimen. So we'll have to wait also for that data to make that determination.

Michael G. King - JMP Securities LLC, Research Division

Okay. And then one set of studies that was, I guess, conspicuous by its absence, or by their absence, was any immune priming studies. There was a fair bit of discussion at AACR regarding the sensitivity to immunotherapies, like PD-1 antibody intervention, subsequent to HMA treatment, so I just wondered if that's on your radar screen and what you might be able to comment about it?

Michael Molkentin

Yes, Mike. That's a good question. We certainly have some plans for immunomodulatory clinical trials. Those plans have not been finalized yet. And these -- the activity to start those kinds of trials have not started yet, that's why we're not commenting on it now. But rest assured, once we start planning and have clear idea about that type of study and also the timeline for that study, we'll be communicating that to you.

Michael G. King - JMP Securities LLC, Research Division

Right, okay. And then if I could, just real quick, turn to Michael Molkentin. I just wanted to say, on the financials, can we just simply take your current cash balance and the net loss, I guess, less amortization of intangibles and just do the subtraction for year end cash?

Michael Molkentin

Yes, that's an oversimplification. I would kind of position it just slightly differently. We're guiding to a $30 million loss and we have, in operating expenses, about $12 million of noncash items, which nets us about $18 million. Now that number can be modified or influenced by any potential development and license revenue that we receive this year, and any payments that we may make on our long-term, or not on our long-term, but on our deferred consideration that we have still outstanding. So yes, to how you described it, but I -- giving you a few more things to think about, but you should probably come within about the same range.

Operator

The next question is from Jason Zhang of Edison Group.

Jason Zhang - Edison Investment Research Limited

Thanks for the update on the pipeline, that was very helpful. But could you also mention the other programs that you have? For example, 283, amuvatinib and are they -- are you still actively conducting trials? Are you have done all the study necessary and you are just waiting for more of a decent decision on those pipelined drugs? And also your own CDK inhibitor 119.

James S. J. Manuso

This is Jim Manuso. First, just let me say that those programs are fully in the hands of our partners. They continue to advance clinically. We intend, of course, to give updates as we receive those. And I think Martin Buckland is in a good position to recite the status on a program-by-program basis. So Martin, would you be so good?

Martin Buckland

Sure, Tim. I think, Jason, to be fair, was actually asking about AT9283, about amuvatinib, and also about AT7519, so it may be better for Mohammad to respond on those 3 programs. I can certainly pick up on the other partner programs.

Mohammad Azab

Yes, for that, we have not -- Jason, this is Mohammad, we have not kind of updated any new information on the 9283, which is an Aurora/JAK kinase inhibitor and the 7519 program, which is the Pan-CDK inhibitor, because these programs we have not started any new trials. And most of the trials that are currently are ongoing are either have been reported or have already fully reported. So the only activity going on with 9283 is studies by Cancer Research U.K. in pediatrics, in solid tumors and pediatrics, leukemia. And the solid tumor trial had enrolled, the leukemia trial is still enrolling. For the 7519, and the only Astex-sponsored study which had complete enrollment is a multiple myeloma study, and we had not reported on that yet. The other 2 trials are not sponsored by Astex, they are sponsored by NCI Canada. This is a chronic lymphatic leukemia trial and a mantle cell lymphoma trial that is currently enrolling with NCI Canada. So that's why the reason, as you know, we are not starting any new trials with these programs. Certainly, once we have completed the trials and we have data from these trials, will be communicated in scientific presentations, and we will update you on that. The only other drug that you haven't mentioned, but I think Martin alluded to, is amuvatinib, or MP470. This is the DNA damage repair inhibitor. We have completed the small cell lung cancer trial, as you know, late last year, and we have reported that we are not progressing this trial further because we have not seen the level of clinical activity that we had basically put the primary endpoint at, although that we have seen responses in that trial, the clinical data from that trial has been presented at the AACR meeting, which reviewed the 23 patients that were enrolled in that trial. So that really completes all the other Astex programs that have not been covered here in the call.

Jason Zhang - Edison Investment Research Limited

And also a question on Dacogen. I guess, Q1 is -- from the revenue -- royalty revenue reported, looks like it's a very similar to Q1 last year. Does that mean the AML indication from Europe really hasn't really have any meaningful contribution to the revenue?

James S. J. Manuso

I'll comment on that. As you know, at this point, the drug is being gradually approved in the G5 and other E.U. countries. We anticipate the ramp up will be meaningful, but we can't really assess that until we've been in the market long enough in order to get some real clarity on that. What we can say and remind people is that our partner's Janssen, very rapidly registered the drug and began selling, marketing and getting it reimbursed in the -- a couple of the G5 countries. And pricing, we don't have great clarity on that as of yet. You know that has to be negotiated in a country-by-country basis, but we certainly believe that the anticipated ramp is going to be meaningful. We don't know when the curves will cross, so to speak, and that's something that we're monitoring very closely. But it certainly is something that we anticipate to fall off as far as royalty revenues are concerned in the U.S. as generics begin to come in next month. So that's something that we'll be updating you on, on an ongoing basis as we learn more.

Jason Zhang - Edison Investment Research Limited

Okay. Just on that subject, you said that generics will come next month. Have we seen a Paragraph IV for filed yet in the U.S.?

James S. J. Manuso

No, it doesn't apply in this instance.

Operator

The next question is from Boris Peaker of Oppenheimer.

Boris Peaker - Rodman & Renshaw, LLC, Research Division

Most of the clinical questions were answered, I just want to know a little clarification on the prior caller's question, specifically, regarding Dacogen royalties. I think, Jim, you just mentioned that the entry of generics is not required for the partner to stop paying royalties. It sounds like it's only when the patent or the orphan exclusivity runs out. Could you just confirm that? And does the same hold in all other geographies? Or are sub-geographies triggered by the entry of a generic?

James S. J. Manuso

Yes and yes. The primary issue here is the rapidity and the number of generics coming in. And we just don't have clarity on that at this point. We certainly believe that it's a meaningful market. And we just don't know at this point, who and how many. Tim?

Timothy L. Enns

Boris, let me give you clarity on that, and you are correct in the way you'd assess it. In every geography, it is a 20-year license that starts from the date of first approval, then in whatever that geography you have your exclusivity period, but the license is for a full 20-year period. What you're referring to is a very common license structure, where there's a patent involved, and when the patent is invalidated or expires, and as soon as the generic entrant come in, then the requirement to pay goes away. That situation does not occur with any of our licenses or regarding Dacogen is that in all of them, we've given you an example, if a new territory were to be brought on board, such as Japan, for AML or something like that. Then the same royalty rate would apply, the same 20-year line, would apply and then whatever Orphan Drug protection would be, would be the exclusivity period.

James S. J. Manuso

Yes, Boris, it's a 20-year payment schedule in each jurisdiction on a jurisdiction-by-jurisdiction basis. So if it gets approved in Japan, say, 5 years from now, that takes us out 25 years. Regardless of generics, regardless of any competitors or anything else.

Operator

The next question is from Michael Yee of RBC Capital Markets.

Michael J. Yee - RBC Capital Markets, LLC, Research Division

Just a follow up on ASCO, do you expect that any of the data in the abstract would be different? Or it's exactly the same that was submitted from ASH? And then when we get to ASCO, obviously, you have durability data from that study as some of those patients have obviously passed away since then. In your clinical experience, what is -- what should investor expectations be for good durability? I mean, obviously, these patients are really, really sick. So a couple of months of durability is good for a response? Help us understand that.

James S. J. Manuso

Mohammad?

Mohammad Azab

Michael, I think -- we do not have any data actually at ASCO. We can -- alluded to that, in one of the press releases regarding that, essentially, as you know, the deadline for submission of ASCO is the 1st of February, which is basically just a few weeks, 6 to 7 weeks from the ASH presentation that we had all of the data presented. So at the time of submission of the abstract, there was not really enough data for that abstract to be considered for the presentation. So we're not presenting at ASCO. We've chosen to follow up on that durability data with both of the European meetings that we have targeted for the year. So we have submitted abstracts for both European Hematology Association, which is coming up in June, and also for the ESMO ECCO, or the European Cancer Congress, which is coming up in late September. Both are European meetings and we have not had exposure in Europe before. As Jim alluded to in the call, we have already our abstract accepted for presentation at the European Hematology Association, which is this year, in June 13 to 16, in Stockholm. That abstract has durability of responses in the MDS population. For the AML population, we have abstract that actually describes some new biomarker data that we have generated from the Phase I and also the durability of responses in the AML population. That abstract was submitted to ESMO. Usually, according to the ESMO ECCO website, we will know around July, if that abstract was selected for presentation or not, then we'll communicate that.

Michael J. Yee - RBC Capital Markets, LLC, Research Division

Okay, and then last question in is on the ongoing relapsed/refractory study. In Phase I, it was fairly sick population, 3 median lines of therapy. In the ongoing study, is there some sort of different entry criteria? Do you expect these types of patients or do you know the types of patients, obviously, since the study completed enrollment in relapsed/refractory AML? Median lines of therapy, are they a little bit more healthy?.

Mohammad Azab

They are still heavily pretreated patients in AML. We wanted them really to reflect our potential Phase III indication. Our view of the Phase III indication is that we will take relapses regardless of the number of prior regimens, unlike some of the other drugs in development in relapsed AML, where they usually kind of focus either on the first relapse or subsequent relapse. We have taken patients with many prior regimens. The only difference is that, for the AML patients, for second line MDS patients, all of them have received Dacogen or Vidaza, while for the relapsed/refractory AML patients in the Phase II expansion, we are not requiring that they have received Dacogen or Vidaza before. But they could have received a number of prior regimens. So they're not really healthier than the Phase 1 population, but we specifically wanted to do that to be reflective of our potential Phase III design. That's why as I said, the most important thing for these patients is we have enough durability of responses in order to be able to forecast an improvement in survival. As you know from some of the relapsed large Phase III trials that have been conducted by other drugs that are currently in development, a recent one that have just been reported a few weeks ago with LSI therapy. The median survival of the drug treatment versus the control arm were 3 to 3.5 months. So the median survival is very short, so hopefully, any impact in terms of durable responses could positively influence such a short survival. And that's really our target population.

Operator

The next question is from Mike King of JMP Securities.

Michael G. King - JMP Securities LLC, Research Division

I'm just wondering Mohammad, Harren, if you could talk about any biomarker development that you're using in conjunction with the 13387?

Mohammad Azab

So for 13387, what we're looking at, it's not going to be -- we don't expect there'll be any predictive biomarkers, Mike, because, as you know, this is a chaperone protein that affects many other client proteins. The main biological endpoints that we're looking at in the Part A of these trials is confirmation in human tumors that we are actually down-regulating the client protein, and thus, providing what I call a biological proof of principle, in that the drug is doing what it's supposed to do in terms of down-regulation of the client protein. We are doing this by collecting tumor material, before treatment and after treatment, and using extensively a technology of circulating tumor cells, which is established for prostate cancer and we're working with another company that had an established CTC detection for lung cancer, and both methods had shown the ability to measure the down regulation of the androgen receptors, in case of prostate cancer, and of the ALK-translocated protein, in case of the lung cancer, and we want to see those first before proceeding to the larger, more expensive Phase II part of the trial. Because, frankly, if we don't see a convincing evidence that we are down-regulating the client protein, then the whole biological principle of the HSP90 inhibition is going to fall short and that's something, as kind of I said to -- many times during corporate presentations and during one-on-one meetings, it is something that's really lacking in the HSP90 inhibitor's development. If you look at all the clinical data generated in the past decade, with all these HSP90 inhibitors, there is not a single one that showed convincing evidence of down-regulation of the client protein in human tumors in patients. We have, of course, tremendous evidence and beautiful down-regulation of client proteins in animal models. But we don't, unfortunately, we don't have that evidence from clinical data yet. And we are struggling hard to get that evidence from our trials before we proceed to the Phase II and, hopefully, Phase III part.

Operator

I would now like to turn the call back over to Dr. Manuso for closing remarks.

James S. J. Manuso

Well, thank you very much for listening in. We look forward to updating you on a realtime, ongoing basis and please don't hesitate, if you have any questions, to contact us. Thank you, again, for your time and attention and have a good afternoon.

Operator

Ladies and gentlemen, this concludes today's program. You may now disconnect. Good day.

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