Curis Inc (CRIS) 2014 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Curis, Inc. Q3 2014 earnings conference call. (Operator Instructions) As a reminder, today's conference is being recorded. I would now like to turn the conference over to Mani Mohindru, Vice President of Corporate Strategy and Investor Relations. Please go ahead.

Thank you, Candace. Good morning, everyone, and thank you for joining us. During today's call, we will provide you with an update on corporate developments and plans and also discuss our third-quarter financial results. Before we begin, I would like to advise you that this conference call contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements relating to our strategy; future operations; future financial position; future revenues; projected costs; prospects, plans and objectives of management; the potential therapeutic benefit of and our plans to develop CUDC-907, CUDC-427 and Debio 0932; and our and our collaborator Genentech and Roche's expectations concerning the continued development and commercialization of Erivedge in various territories and expected growth in Erivedge sales.

Actual results may differ materially from those indicated by forward-looking statements in this conference call as a result of various important factors including those risk factors described in our quarterly report on Form 10-Q for the quarter ended September 30, 2014 and in other filings that we periodically make with the SEC. And we encourage you to review these risk factors carefully. We caution you that we are making these forward-looking statements only as of today and that we may not update any of these statements, even if events and developments subsequent to the date of this call cause these estimates and expectations to change.

I'd now like to introduce Ali Fattaey, our President and CEO, who will provide an update on our Company and our various programs including CUDC-907, CUDC-427, Debio 0932 and our partner program, Erivedge. Following Ali's remarks, Mike Gray, our Chief Financial and Chief Business Officer, will review our financial results for the third quarter 2014, after which we will open the call for questions.

During the Q&A period, as a courtesy to individuals seeking to ask questions, we ask that the participants limit themselves to one or two questions only. Ali?

Thank you, Mani, and thanks to conference call and webcast participants for joining us this morning. Just to give you a brief introduction to the Company, we are focused on the development of novel oncology drug candidates. Our current development pipeline includes CUDC-907, which is an oral inhibitor of HDAC and PI3 kinase enzymes, and CUDC-427, an oral antagonist of IAP protein.

Our first marketed product, Erivedge, is a first-in-class drug targeting the Hedgehog pathway that was developed and is being commercialized by our collaborators, Genentech in the United States and by Roche outside the US, for the treatment of advanced basal cell carcinoma, or BCC. We receive a royalty from Erivedge sales and expect this royalty-based revenue stream to continue for the foreseeable future. We also expect that our current cash position should enable us to execute our current operating plans well into 2016.

On the development side, I will begin with discussing the progress being made with each of our drug candidates CUDC-907 and CUDC-427 and also provide an update on Debio 0932, our second-generation oral HSP 90 inhibitor.

CUDC-907 is our oral dual HDAC PI3 kinase inhibitor that is being studied in a first-in-human trial in patients with relapsed and refractory lymphoma and multiple myeloma. To date, 41 patients have been treated in the Phase I trial evaluating CUDC-907 at escalating doses using various treatment schedules. 10 patients are still continuing to receive CUDC-907 treatment on this study while other patients eventually discontinued treatment either due to disease progression or side effects per study protocol.

The safety profile of CUDC-907 remains consistent with what we reported at the 2013 ASH conference. Overall, diarrhea, thrombocytopenia, and fatigue remain the most frequent side effects, with diarrhea and hyperglycemia also identified as dose-limiting toxicities. Using the optimized dose and schedule of administration, adverse events have been manageable and consistent with CUDC-907's known mechanism of action as a potent HDAC and PI3 kinase alpha and delta inhibitor. Evidence of HDAC and PI3 kinase enzyme modulation has been observed in pharmacodynamic analyses using patients' peripheral blood mononuclear cells as a surrogate tissue source.

With regards to clinical benefit, among the 8 disease-evaluable patients with diffuse large B cell lymphoma, or DLBCL, that are treated -- that have been treated in the dose escalation phase of the trial, 7 patients have experienced tumor shrinkages, including one patient with a complete response, 2 patients with partial responses and 4 patients with tumor shrinkage ranging from 5% to 46% that are classified as stable disease with regards to their best response. Patients for whom objective responses were observed were in the higher or more intensive dosing schedule.

We recently initiated the expansion phase of the study and expect to continue enrolling up to 12 patients with DLBCL in this phase of this study. We are encouraged by the single-agent activity in patients with relapsed refractory DLBCL thus far and look forward to data from the ongoing expansion phase to further define the therapeutic potential and a possible regulatory path for CUDC-907 in this indication.

In addition to the ongoing study in hematologic malignancies, in the coming weeks we will initiate a second Phase I trial testing CUDC-907 in patients with solid tumors, including hormone receptor-positive breast cancer. Full details of that trial will be released with the initiation of this study.

I will now turn to CUDC-427, which is our oral small molecule smac mimetic that is designed to promote cancer cell death by antagonizing IAP proteins. In June of this year, we reinitiated enrollment and treatment of patients with advanced refractory solid tumors or lymphomas onto the monotherapy Phase I trial. Patients enrolled in this study are now being administered CUDC-427 on a 14-days-on, seven-days-off dosing schedule in a 21-day cycle in sequential dose escalation cohorts at doses of 100, 200 and 300 milligrams once-daily dosing. Enrollment in all three dosing cohorts has been completed, and no significant toxicity signals have been observed thus far. Based on the cumulative safety pharmacodynamic and clinical benefit data to date, we expect to initiate the expansion phase of the trial at the recommended CUDC-427 dose in the near future.

With regards to our partner programs, as mentioned in our press release earlier this morning, Debiopharm has opted to not advance Debio 0932 into the Phase II randomized portion of the HALO study in patients with advanced non-small cell lung cancer. Debiopharm viewed the Phase I data using three different standard-of-care chemotherapy regimens in these disease setting as inconclusive for advancement.

Importantly, no new or unexpected safety signals were identified with Debio 0932 in this trial. We expect to receive formal notice of termination of the license agreement from Debiopharm soon and intend to enter into a transition agreement in the fourth quarter of 2014 regarding the orderly return of the program and all rights for Debio 0932 to Curis.

Additionally, after careful analysis of Debio 0932's pre-clinical and clinical profile as well as the Hsp90 field in general and in discussion with expert investigators, we have identified the systemic mastocytosis, which is a myeloproliferative neoplasm, and glioblastoma multiformae as potential indications for further development of Debio 0932 once we regain the rights to the drug candidate.

Key investigators in each of these fields have expressed a strong interest to explore whether Debio 0932 can address significant unmet medical needs for these patients in the past and currently. We expect to share additional details regarding our plans for potential collaborative or investigator-initiated trials with Debio 0932 in the coming months.

I'll now turn to Erivedge, which is being developed and commercialized globally by Genentech and Roche under our collaboration. Roche continues to concentrate on the global commercialization of Erivedge for treatment of advanced BCC in key territories worldwide. Erivedge has been approved in more than 50 countries, and Roche continues to pursue marketing approvals in many others.

During the third quarter, net sales were essentially flat as compared to the prior quarter; this, after a significant sequential quarterly increase of approximately 40% during the second quarter. Genentech has advised us that it expects revenue growth in the fourth quarter as well as in 2015 and beyond.

We recorded royalty revenues of approximately $1.8 million for the third quarter this year as compared to $1.1 million for the third quarter of 2013. Approximately two-thirds of this Erivedge sales were derived in the US, with the remaining sales being generated outside of the US. We note that in many countries in the EU and elsewhere, reimbursement negotiations are still ongoing, and we expect the ex-US sales contribution to increase for Erivedge.

Roche is also conducting additional Erivedge exploratory studies in patients with less severe forms of BCC, including a 220-patient Phase II study in patients with multiple BCC lesions as well as a study of Erivedge with surgery in patients with BCC. We will provide updates on data from these studies as they become available.

In addition, in June of 2014, Roche filed an IND application with the FDA to initiate a multi-center Phase II clinical study of Erivedge in patients with idiopathic pulmonary fibrosis, or IPF, which resulted in a $3 million cash milestone payment to us. After the Phase II study opened but prior to patient enrollment, Roche suspended this study in August in order to incorporate certain protocol design amendments.

Our growing body of mechanistic, clinical and safety data confirms the potential of our wholly-owned and partner programs to lead to novel treatments for patients with cancer. We remain firmly committed to pursuing compelling agents in oncology in order to address the unmet clinical needs of patients with cancer. Curis continues to build momentum, the results of which we look forward to sharing at upcoming scientific and medical congresses.

I would now like to turn the call over to Mike Gray for his discussion of our financial results.

Okay. Thanks, Ali. For the third quarter, we reported a net loss of $5.6 million, or $0.06 per share, on both a basic and fully diluted basis as compared to a net loss of $1.9 million, or $0.02 per share, on both a basic and fully diluted basis for the same period in 2013. Revenues for the third quarter of 2014 were $1.8 million as compared to $7.2 million for the same period in 2013. The decrease in revenues was primarily due to a decrease in license fee revenue as a result of a $6 million milestone payment earned from Genentech upon the conditional approval of Erivedge by the European Commission in July 2013.

The decrease in license fee revenues was partially offset by royalty revenues recorded on Genentech and Roche's net sales of Erivedge, which increased to $1.8 million during the third quarter of 2014 as compared to $1.1 million during the same period in 2013. Operating expenses for the third quarter of 2014 were $6.5 million as compared to $7.1 million for the third quarter of 2013. Cost-of-royalty revenues, which are comprised of amounts due to third-party university patent licensors in connection with Genentech and Roche's Erivedge net sales of $89,000 and $54,000 during the third quarters of 2014 and 2013 respectively.

Research and development expenses were $3.7 million for the third quarter of 2014 as compared to $4.2 million for the same period in 2013. The decrease was primarily due to a decrease in sublicense fees of $300,000 that we incurred related to third-party obligations and milestone payments received from Genentech during the third quarter of 2013.

There was an increase in spending on CUDC-907 in the third quarter of 2014 related to our ongoing Phase I clinical trial and, to a lesser extent, to costs associated with our efforts to open a second Phase I trial in solid tumors. This increase was partially offset by decreased spending on CUDC-427 as compared to the third quarter in 2013.

General and administrative expenses were $2.7 million for the third quarter of 2014 as compared to $2.8 million for the same period in 2013. Other expense was $827,000 for the third quarter of 2014 as compared to $2 million for the third quarter of 2013 and is primarily comprised of interest expense associated with the loan paid by BioPharma-II to Curis Royalty, which is a wholly-owned subsidiary of Curis, as well as expense associated with the change in fair value of a warrant liability. Interest expense was $934,000 and $965,000 for the third quarters of 2014 and 2013, respectively. The Company recorded other income of $68,000 and other expense of $1.1 million, respectively, associated with the change in the fair value of a warrant liability during the third quarters of 2014 and 2013, respectively.

As of September 30, 2014, our cash, cash equivalents, marketable securities and investments totaled $56.1 million, and there were approximately 86 million shares of our common stock outstanding.

With that, we'd like to now open the call for questions.

(Operator Instructions) Adnan Butt, RBC Capital Markets.

Congrats on the data. Question is -- this is the first time the DLBCL data has been presented in some detail. What's kind of a timeframe to expect data from the expansion cohort? And then could you put the data in perspective? Would you expect drugs to be used as monotherapy in combination? And if combination, what 907 combination work has been done so far? Thanks.

Sure, Adnan. This is Ali. Thank you for your question. Yes, this is the first time that we have presented some of the more detailed data on the current DLBCL patients from the dose escalation stage, which is the 8-patient data that we just talked about. The expansion cohort or the expansion phase just recently started last month, as you know, and we have patients that are enrolling into that DLBCL patients. These patients can come on at any time. There is no restriction in terms of 3 by 3 design or anything. All patients can come into that. We are hopeful that within the first half of 2016 we would have data regarding the expansion cohort for DLBCL. Our expectation is that since all of those patients would be getting the drug at dose that we would see similar results to what we've observed so far, which has been across the board with regards to dosage and schedule. That's our expectation.

With regards to plans, obviously we are looking carefully to see whether we would follow a monotherapy, single-agent path or a combination treatment path for DLBCL. That will all depend on the level of benefit that we would see as a monotherapy agent in the dose expansion or the expansion phase.

The types of agents that we have and consider potentially combining CUDC-907 with are standard-of-care chemotherapy agents for the relapsed refractory setting. This would potentially include combinations of gemcitabine and oxaliplatin, gemox. We've also, in the pre-clinical settings, examined ibrutinib, and we've also examined combination treatments in multiple myeloma settings pre-clinically such as proteasome inhibitors and IMiDs, lenalidomide and others.

For DLBCL, other chemotherapy regimens that we would potentially consider as well would include, for example, R-CHOP and R-ICE treatment regimens. At the moment, however, we are focusing on the monotherapy single-agent treatment to see the level of benefit that we see from that and then determine whether our path would be single agent or combination depending on the level of benefit that we observe.

Thanks. Congrats. I'll get back in line.

Joe Pantginis, ROTH Capital.

Thank you for the update. A couple of questions, please. I guess a more broad question regarding Erivedge. Can you point to what you believe I guess the catalyst for growth might be? Obviously, they are looking to expand in the territories they are already approved in, and they are looking to get new approvals as well. Anything you can point to with regard to therapeutic indications as Roche continues to look at that area as well?

Well, I mean, the same thing that has been going on. As you knew, earlier in the year, toward the first quarter, Roche and Genentech restructured a little bit of their sales force and streamlined it with regards to cutaneous cancers. So there's much more of a focus of the marketing group and sales force on that.

I would say the other area of focus that's also coming is a recognition that there needs to be much more of a focus on dermatologists and most surgeons as opposed to oncologists for the continued marketing and education of the prescribers for Erivedge in that regard.

And of course, ex-US, the current focus is on reimbursement negotiations, particularly in certain European countries, and a little bit behind that is the negotiations going on with regard to Australia. So they're really in the US more focused on dermatologists and do the same thing that's currently ongoing ex-US is all the price negotiations ongoing at the moment.

That's really helpful. Thanks, Ali. And then maybe just some follow-up with regard to the Debio news. I guess first, maybe some more color on what Debio was looking at when they said it was inconclusive with regard to how they looked at dosing and regimens. And is there anything that you identify that you might look to change on that and that could provide some additional information on your end?

And then what led you -- maybe a little more color as to what led you to the mastocytosis and the glioblastoma indications. And then I guess potential timing of moving those things forward; I know it would be dependent on having the transfer being complete. And then would you potentially look to re-partner the drug? I know there was a lot in there. Thanks a lot.

Sure. Thanks for the four questions on Debiopharm, Joe. I'll try and answer them for you one at a time.

(laughter) I broke the rules, Mani. Sorry.

No, of course, as you can imagine, this is relatively new for us. So we are still in understanding parts of this and also thinking through our path for the drug candidates as well. Predominantly, I think obviously Debiopharm was looking at the clinical data. And clinical data in this case was in three different arms for an unselected population of non-small cell lung cancer patients. The three different chemotherapy regimens, which were gemcitabine, cisplatin -- pemetrexed cisplatin, as well as docetaxel in the second line.

I think with an unselected population it was difficult to try and identify which, if any, of those paths would be fruitful going forward and that may also signify whether -- to be all honest, whether lung cancer is an indication to pursue for an HSP 90 inhibitor. I know there's other studies ongoing in lung cancer as well. But the data at this point didn't merit or didn't really point to a single direction based on those chemotherapy combination regimens to go forward at that point.

Much of our focus, the way we look at Debio 0932, very similar to in general the way we look at our drug is to look for single-agent activity first and foremost and then pursue potential combination therapy strategies in a particular indication. We have had discussions in the past and expressions of interest from investigators in the past including proliferative -- myeloproliferative neoplasms and, in particular, glioblastoma as well. The glioblastoma interest really came from the potential use of any HSP 90 inhibitor and in particular one like Debio 0932 that crosses the blood-brain barrier, at least in pre-clinical models.

With respect to mastocytosis in particular as a myeloproliferative neoplasm, the rationale really stems from the high prevalence and incidence of KIT mutations, which happens to be a client protein for Hsp90. And there is pre-clinical data indicating the potential use of Hsp90 in that indication.

These are a couple of indications where we think the monotherapy could potentially demonstrate a benefit. They are both very, very much an unmet need, and it would require more of a modulation of the target rather than having to completely eliminate a particular target, especially with single agent.

We are in discussions with those investigators. We have renewed some of the discussion with them to see whether they would be interested in participating in clinical studies either as Company-sponsored or investigator-sponsored studies going forward at this point. And, as I pointed out, these are relatively very recent conversations, so no update on that.

With regards to whether we would continue taking it forward or partner it, we -- as a general rule for the Company, we are always open to partnering strategies if it helps the development of the drug and, in particular, if it's in territories where we may not have an interest in commercializing our drug. In general, we would stay focused within the US market and potentially the EU market. But in Asia, we very much welcome partnering strategies, and that would include for Debio 0932.

Thanks a lot, guys. That was very helpful.

Brian Skorney, Robert W. Baird.

This is Morgan on for Brian. I just had a quick question if you could remind us on the color of the dosing schedule in the expansion cohort for 907. Can you just give us a little more color on that? Thanks.

Yes, just maybe as a background as well, the different schedules of administration that we tested and are testing in the dose escalation part included the daily and included intermittent dosing, which was either three times per week or twice per week. And much more recently, we have initiated a slightly more intensive dosing schedule of five days on and two days off treatment schedule. That last schedule started at 60 milligram, and that's the dose that the schedule is at currently.

With regards to the intermittent dosing of three times or twice a week, we determined 120-milligram dose to be the optimal and recommended dose for further development, and 120 milligrams 3 times a week is the dose that the expansion cohort is currently enrolling at. Does that answer your question?

I'm sorry?

I just wanted to make sure that answered your question, Morgan.

Yes, it definitely does. And then I just had one more quick question on the IP after Erivedge. I noticed that you mentioned that they have gone back and done some protocol adjustments. Do you know what the timing on that will be to get back online? Do you know what the progress is there?

Our expectation is -- or the signals that we get, the expectation is next year. No additional information to provide to you with regards to the types of modifications to the protocol at this point.

Okay, cool. Thanks.

Boris Peaker, Cowen.

I'd like to ask a question on Erivedge. And just more specifically, what are the changes that Roche is making to the IPF study? And also, has the recent InterMune acquisition in your opinion had any impact in terms of the development process or anything of Erivedge in IPF?

As I said, we don't really have more information to give you with regards to the design modifications that are going to go in there. I can't really comment on Roche and Genentech's strategy with regards to InterMune. But I can say that the initial Phase II study that they currently filed with and opened the trial for IPF was a Phase II randomized trial and randomized to placebo.

The question really remains with the approval of -- with the potential approval of agents like InterMune in the IPF disease setting, whether it's really valid to do a control arm of placebo only for patients with IPF. That is really the amount of color that we can add. But with regards to what the eventual design of the study would be for Genentech and Roche to restart that, we can't comment at this point.

Okay. Thank you for that explanation. And on Erivedge, also in hematologic malignancies, I believe that there was some more being done in AML and MDS. Could you update us on the status of that?

Yes. I think we actually did put a press release out on that or maybe gave some guidance on one of the conferences. The AML and MDS study they did in interim look at the data, and the level of clinical benefit or responses did not meet Genentech's internally set criteria for a threshold to initiate the Phase II portion of that. Therefore, it's not continuing at this point.

Got you. Thank you very much for answering my questions.

Brian Klein, Stifel.

Just two on 907. First in regards to the expansion cohort in DLBCL, you mentioned that you might be considering long term looking at combination studies depending on the outcome of that expansion phase. But are you going to allow enrollment of patients who have received prior treatment with either IMBRUVICA or Zydelig? And then I have a follow-up, please.

Yes, they can -- in the current expansion cohort that is enrolling, DLBCL patients, they can have prior treatments including the ones that you mentioned.

Great. Thank you. And then in terms of follow-up, if I look at this data that you are reporting on today in the 8 evaluable patients, can you give us a sense of how you view this in comparison to the previously reported data for other PI3Ks and whether you think the HDAC component of 907 is having a significant improvement on other PI3Ks? Thank you.

Sure. I think with regards to the data that we see, certainly we are very pleased to see that 7 of the 8 patients have had some amount of clinical benefit with tumor shrinkages, including the complete response and partial response and also a patient at 46% tumor shrinkage, which is significant for all the patients. So we are happy with that.

With regards to comparison to other single agents including PI3 kinases, I don't know the breakdown as well. But this level of benefit in DLBCL patients, specifically for PI3 kinase delta or other antagonists or pan inhibitors, has not been seen.

We've also looked at the -- some of the data that is available for HDAC inhibitors in general as a single agent. And so far, this level of clinical benefit that we see, albeit again a smaller number of patients, seems to be beyond what we've seen with HDAC inhibitors. So our current assumption and assessment is that, yes, the dual inhibition is potentially having a benefit and hopefully beyond what the single agents can do.

We're also happy to see modulation of enzyme activity for both PI3 kinase and HDAC enzymes based on patients' PBMC samples. And as I pointed out with respect to the side effect profile, we are seeing both HDAC and what we believe to be PI3 kinase inhibition based on a side effect profile if we use that as a marker as well.

So, overall, I would say we are seeing a dual-active agent, and the current level of benefit that we see in DLBCL patients is somewhat above what's been seen with single agents, either PI3 kinase or HDAC inhibitors.

Great. Thank you.

Chris Marai, Oppenheimer.

First, on Debio 0932, just wondering with respect to mastocytosis -- you know, obviously there's significant unmet need there. You know, you could obviously explore various endpoints. Have you started to look at the potential endpoints including potentially symptomatic relief given the nature of that disorder?

Thank you, Chris, for the question. I think I'm going to be -- ask for forgiveness just again because these are some of the more recent discussions we are having with investigators. I don't think we have a design for the trials planned yet. And hence, I don't want to comment on endpoints which are the most relevant endpoints. However, as you pointed out, our understanding of mastocytosis is that it is a fairly large and unmet condition. And patient quality of benefits is also an important factor. But really no design or endpoints at this stage.

Great, okay. Then just another question on 907. The data actually looked really encouraging for that one patient with multiple myeloma. They appear to be doing quite well. Do you have any information on one, prior therapies, and then two, any mechanistic rationale for why you think that patient is performing so well?

Sure. As we had pointed out, we didn't really cover it in the call this morning -- remember, we did in our release -- that the one patient that has continued to receive CUDC-907 now for 22 months, pretty much the beginning of the start of the trial, continues to benefit from CUDC-907. We don't have as much data from multiple myeloma patients in general, and that's part of the reason we have waited trying to give an update on it at this point. Nothing specific with regards to that patient as to why they benefit for an extended period of time versus potentially other patients.

I would also point out that a number of different other lymphoma patients have also been treated, and not only DLBCL patients associated with this. We only updated on the DLBCL group to give more color with regards to the rationale for the expansion cohort at this point.

Okay. Thank you.

(Operator Instructions) Ted Tenthoff, Piper Jaffray.

I apologize if this question has already been asked. I'm kind of bouncing back and forth between things this morning. So, congrats on the DLBCL data. Looking at the Hsp90, what comes back from Debiopharm? Is there any money that needs to be recognized? Is there drug supply? What exactly from kind of a more data and/or kind of corporate endpoint do you actually get back?

With regards to the agreement itself, once we receive a termination notice from Debiopharm -- and I point out that we have not received that yet, although we expect to receive it -- we would enter into a transition agreement to make sure that all the process that you just described is done in an orderly fashion. Per the agreement, Curis is entitled to get all data associated with it but not necessarily any other material associated with Debio 0932.

So allow us to receive the notice and also proceed with a transition agreement with Debiopharm, and we would be able to provide additional color in terms of what material they need to change with respect to Debio 0932 in the meantime.

Okay, great. Thank you very much. Were there other studies ongoing decides HALO in lung?

No. The only other trial that Debio 0932 was in was the renal cancer trial that ended earlier this year. That was a combination with a mTOR inhibitor. However, that study ended due to potential drug-drug interactions between the two drug agents at that time. So the HALO was the only ongoing study at Debiopharm with Debio 0932.

Great. Thank you for the update, Ali.

Ling Wang, Chardan Capital.

Thank you for taking my questions, and congratulations on encouraging data for 907. Just a follow-up on 907. Can you comment on the rationale for selecting the 100-migs dose in the three-times-per-week dosing schedule in the expansion study? And also, any color on the dose response in the different cohorts? And then maybe can you tell us out of the 41 patients in the Phase I study, how many patients are the DLBCL patients and whether we have a chance to see updated results sometime in the near term? Thank you.

Sure. With regards to the dose and schedule of CUDC-907, just to rehash, we did, obviously, several different schedules, and each one of them was associated with a escalation phase.

With regard to the intermittent dosing of the drug, which included either 3-times-per-week or 2 times-per-week dosing of CUDC-907, we initiated with 60 milligram and escalated all the way to 150-milligram dose based on the safety profile and the current of frequent adverse events as well as dose limiting toxicities. We determined 120 milligrams to be the maximum tolerated dose when administered 3 times per week. There actually was not a significant difference between the safety profile at 2 times per week versus 3 times per week, so we opted for the more -- slightly more intensive dosing and exposure of the drug for the patient.

At those doses, we also saw good biomarker activity based on the pharmacodynamic analysis that we did and also good exposure for the patients. So that's the rationale for the dose, and schedule was based on safety, pharmacodynamics and PK profile of the drug. Daily dosing was obviously not an option for us simply because it was associated with dose-limiting toxicities at the initial dosage of it -- of the drug.

With respect to -- and I apologize, Ling, maybe the second part of your question, I --?

Oh, yes. I was wondering how many patients -- how many DLBCL patients are there in this Phase I portion? And since you reported 8 patients worth of data whether we could see more update in near term for the rest of the DLBCL patients.

The 8 that we described were all of the DLBCL patients enrolled in the dose-escalation stages of the trial. So that's all of the DLBCL patients. As we pointed, the expansion cohort is open and enrolling patients -- DLBCL patients. We expect to enroll up to 12 DLBCL patients in that expansion cohort and really 2015, hopefully before the -- and within the first half of the year is when we would hope to have additional data that would allow us to give you updates on that perhaps in the next quarter.

I see. Just a quick follow-up. So you said the trial also is evaluating the five-days-on and two-days-off schedule. So, that schedule is only dosing the patients with multiple myeloma? Is that the right way to think about it?

No. It's actually -- the 5-2 is a continuation of the dose escalation and schedule optimization part of the study. So any patients could be enrolled in the 5-2 dosing schedule.

And part of -- as we discussed, I think, during the last earnings call as well, I want to point out here that we did get our IND also accepted -- a separate IND accepted for treatment of solid-tumor patients and whether that study will enroll patients at 5-2 dosing schedule or the 120-milligram, 3-times-a-week schedule or both of those is the way that we are looking at it.

So that 5-2 schedule is really to get experience with that more intensive dosing and also potentially carry it into the solid-tumor testing trial as well. So consider the 5-2 as another schedule that is being examined on a dose escalation in a dose escalation part of the study.

Great. That really helps. Thank you.

Thank you. And I'm showing no further questions at this time. I would like to turn the call back over to management for any closing remarks.

Thank you very much for all the participants. And we would like to thank our employees, our directors, investors and partners for their continued support. And most of all, we would like to thank the patients and their families who participate in all of our trials. We look forward to providing you all with further updates on our progress over the coming months. Thank you.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Have a great day, everyone.