Curis Management Discusses Q3 2013 Results - Earnings Call Transcript

Nov. 6.13 | About: Curis, Inc. (CRIS)

Curis (NASDAQ:CRIS)

Q3 2013 Earnings Call

November 06, 2013 8:30 am ET

Executives

Mani Mohindru - Vice President of Corporate Strategy and Investor Relations

Ali Fattaey - President and Chief Operating Officer

Daniel R. Passeri - Chief Executive Officer and Director

Michael P. Gray - Chief Business & Chief Financial Officer, Principal Accounting Officer and Secretary

Analysts

Simos Simeonidis - Cowen and Company, LLC, Research Division

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Brian P. Skorney - Robert W. Baird & Co. Incorporated, Research Division

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

Operator

Good morning, ladies and gentlemen, and welcome to the Third Quarter 2013 Curis Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded for replay purposes. I would now like to turn the call over to Mani Mohindru, Curis Vice President of Investor Relations and Corporate Strategy. Please proceed.

Mani Mohindru

Thank you, Catherine. Good morning, and thank you for joining us. During today's call, we'll provide you with an update on corporate plans and developments and also discuss our third quarter 2013 financial results. Before we begin, I would like to advise you that this conference call contains forward-looking statements within the meaning of Private Securities Litigation Reform Act of 1995 including, without limitation, statements related to the status and plans for further development of CUDC-427, our plans and expectations for advancing the clinical development of CUDC-907, our plans regarding further treatment and development of CUDC-101, the potential therapeutic benefits of these development candidates, our and our collaborator Genentech and Roche's expectations concerning the commercialization of and market opportunity for Erivedge in various territories, expected growth in Erivedge sales in 2013 and beyond, Genentech's plan for ongoing clinical trials of Erivedge and the presentation of data related to those trials, our and our collaborator Debiopharm's expectations regarding the clinical development of Debio 0932, on guidance with regard to the period, in which we expect to have cash available to fund our operations, and our ending cash balances for fiscal 2013. 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 June 30, 2013, and in other filings that we periodically make with the SEC, and 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 do introduce Ali Fattaey, our President and Chief Operating Officer, who will provide update on CUDC-427, and also provide an overview of the Phase I study with CUDC-907. Following his remarks, Dan Passeri, our Chief Executive Officer will provide an update on our partnered program, and Mike Gray, our Chief Financial and Business Officer will review our financial results for the third quarter 2013 and then we will open the call for any questions. [Operator Instructions] Ali?

Ali Fattaey

Thank you, Mani. Good morning, and thank you for joining us today. I will begin with an update on the status of the clinical study of our proprietary drug candidate CUDC-427, a trial that we initiated in July of this year. For context, I'd like to review prior clinical experience with CUDC-427. CUDC-427 was tested in a 42-patient Phase I dose escalation study sponsored by Genentech, the results of which were presented at the ASCO conference in June this year. That study examined escalating doses of CUDC-427, starting at 5 milligrams, and enrolled patients in 11 dose cohorts up through a 600-milligram daily dose using a schedule of 14 days on, followed by 7 days off, in 21-day treatment cycles. Maximum tolerated dose of the drug was not determined in that study. Regarding safety, one DLT of grade 3 fatigue was documented at the 450-milligram dose level.

Grade 3 or higher adverse events that were attributed to CUDC-427, included elevated serum levels of AST and ALT liver enzymes in 2 patients, anemia, fatigue, neutropenia, pruritus or itching sensation, fever or rash experienced in one patient each. In that study, no serious adverse events, or SAE's, were attributed to CUDC-427, and overall, the drug candidate was deemed to be reasonably well tolerated. Potent biomarker activity as measured by over 90% decrease in cIAP protein levels, which is a target for this drug, was observed starting at the 90-milligram dose. Drug exposure at levels equivalent to ED50 and ED90 based on animal models were reached in the clinic at daily doses of approximately 90-milligram and 450-milligram respectively. Drug half-life was recorded as approximately 4 to 8 hours. Complete tumor regressions, albeit unconfirmed, were recorded in 1 patient with ovarian cancer and another patient with MALT lymphoma. And disease stabilization was experienced by 8 other patients. We initiated an additional Phase I trial of CUDC-427 in July this year, to expand upon findings from the Genentech trial by addressing important considerations, including; A, safety, tolerability and maximum tolerated dose of a more intensive dose regimen of single agent CUDC-427, namely twice-daily continuous treatment without a drug holiday. And B, potential clinical benefit in ovarian and fallopian tube cancer patients, with defined genetic alterations.

In this study, 9 patients have been enrolled into 1 of 3 dose cohorts testing, 200-milligram, 300-milligram, or 400-milligram twice daily dosing. During the course of treatment, one patient with stage 4 breast cancer metastatic to the liver, lung, bone and ovaries who was enrolled in the mid-dose cohort experienced grade 3 serious adverse events of increased AST and ALT liver enzymes. Unlike all prior clinical experience with CUDC-427, this patient's liver enzymes and later her bilirubin level, continued to rise following discontinuation of CUDC-427 and the patient died of liver failure one month following CUDC-427 discontinuation.

In response to our reporting of this event, on November 5, yesterday, we received written notification from the FDA placing the CUDC-427 Phase I trial on a partial clinical hold. Under this partial clinical hold, new patients may not be enrolled in this study until we provide FDA with requested additional data and analysis on patients treated with CUDC-427, and a proposed protocol amendment is submitted and accepted by the FDA.

To date, no other patients treated with CUDC-427 have experienced a serious event of this magnitude or nature. We will provide the FDA with their requested information and data analyses. We are in the process of assessing CUDC-427's pharmacogenetics, concomitant medications, patient specifics and other trial parameters related to this event in the context of all prior clinical experience with CUDC-427. We expect that these analysis will not only help elucidate factors that may have contributed to this patient's clinical course, but should also inform proved future developments of CUDC-427. Based on clinical data obtained to date, we continue to believe that CUDC-427 could play an important role as monotherapy for patients with genetically-defined cancers, and in combination with chemotherapy or other targeted anticancer agents in select indications such as breast cancer. Accordingly, assuming that we are able to satisfactorily respond to the FDA's information request, and the FDA removes the partial clinical hold so that we can reinitiate enrollment in the clinical study, our development plan for CUDC-427 currently remains unchanged. I will now turn to our other clinical stage, proprietary drug candidate CUDC-907, which is a dual PI3 kinase and HDAC inhibitor. I'd like to note that CUDC-907 is being developed in collaboration with the Leukemia and Lymphoma Society or LLS, and we thank the LLS for its important guidance and support in the development of this drug candidate. CUDC-907 is being tested in a Phase I dose escalation trial in patients with relapsed refractory lymphomas and multiple myelomas. Patients may be enrolled at 3 different centers to receive CUDC-907 administered using one of the following 3 schedules: once daily, 3 times per week, or 2 times per week administration. Based on preliminary PK results from the once daily treatment schedule, we have seen encouraging drug exposure, and a metabolism profile for CUDC-907 in patients, which is similar to that observed in animal models. To date, common observed adverse events of reversible thrombocytopenia and gastrointestinal effect including diarrhea, have been consistent with known side affects of HDAC and PI3 kinase inhibition. No unexpected toxicity [ph] signals have been observed thus far in this trial. While, study findings are still preliminary, clinical benefit in some patients have been observed. We are planning to share additional results from this study at the upcoming American Society of Hematology Annual Meeting or ASH in early December. In addition to the ongoing trial in hematologic indications, we are also planning to initiate an additional Phase I trial in which CUDC-907 will be studied in solid tumor patients. We expect to provide additional details regarding this trial, and as we get closer to its initiation. I'd now also like to thank Jaye Viner, our Chief Medical Officer, and Tania Chander, our Vice President of Product Development, and their team as well as all members of the Curis staff for their hard work and their contribution to the discussion that we are having today. I'll now turn the call back to Dan to provide for more details on our partnered programs. Dan?

Daniel R. Passeri

Yes, thanks Ali. I'll begin with Erivedge, which is being developed and commercialized globally by Genentech and Roche, under our collaboration. The third quarter was marked by the continued commercialization and market expansion of Erivedge by Roche and Genentech. They have now secured Erivedge marketing approvals in key territories worldwide, including the United States, the European Union, Australia, Canada, Switzerland among others. Curis is entitled to a royalty on worldwide sales as well as certain development in regulatory milestones. For instance [ph], in June of this year, Erivedge received conditional approval in the European Union, resulting in a $6 million milestone payment to Curis. Roche is working towards the commercialization of Erivedge in various EU Member states. We believe that physicians' adoption of Erivedge in advanced basal cell carcinoma continues to be positive as reflected by the sustained growth in quarterly sales, since its U.S. launch in February 2012. During the third quarter of 2013, Roche reported net sales for Erivedge of approximately $22 million, representing a quarter-over-quarter increase of approximately 30%.

Based on early market launch metrics, we continue to expect that Erivedge in the advanced BCC market has the potential to represent significant value for our shareholders and we anticipate that Genentech and Roche's net sales of Erivedge and consequently our royalty revenue will continue to grow in the fourth quarter of 2013 and beyond.

Genentech has also completed a Phase II trial of Erivedge in patients with new nonrecurrent operable modular BCC, which is a less severe form of the disease compared to locally advanced and metastatic BCC. Genentech and Roche are currently analyzing the data from all 3 cohorts of the study, and Genentech has stated to us that it will present the results of this study at a medical meeting in early 2014.

Additionally, during the third quarter, Roche initiated a Phase Ib/II trial of Erivedge in patients with relapsed refractory AML, and relapsed refractory high-risk MDS, which we hypothesize to be associated with ligand-dependent abnormal hedgehog signaling. It's believed that selective targeting and blocking of the hedgehog signaling pathway may have an effect on leukemic stem cell proliferation and survival. Hence, we believe that inhibition of the hedgehog pathway has the potential to provide benefit to the patients with AML and MDS, and we're pleased that Roche is determined to invest in exploring Erivedge and these diseases. We look forward to providing updates on Erivedge's ongoing studies as well as its continued commercialization in various territories as these updates become available.

Regarding Debio 0932, I'll give you an update now. We continue to be impressed with our partner, Debiopharm's rigorous approach investigating Debio 0932, which is an oral Hsp90 inhibitor in cancers with strong scientific rationale and supporting preclinical data. Debiopharm is currently completing the Phase I portion of the ongoing halo trial of Debio 0932 in non-small cell lung cancer patients. Debiopharm has indicated to us that it anticipates advancing Debio 0932 into the Phase II portion of this lung cancer study during 2014, where it would be further evaluated in combination with standard of care chemotherapy regimens, in both treatment-naïve as well as previously treated lung cancer patients. We are entitled to the next milestone payment after the fifth patient is enrolled in the Phase II study. Additionally, Debiopharm recently started a Phase I trial of Debio 0932 in combination with an emtor [ph] inhibitor, veralomis [ph], in patients with advanced or metastatic renal carcinoma based on preclinical and mechanistic evidence of potential benefit with this combination for kidney cancer patients. Now, I'd like to turn the call over to Mike for discussion of our financial results. Mike?

Michael P. Gray

Thanks, Dan. We reported a net loss of $1.9 million or $0.02 per share on both a basic and fully diluted basis for the third quarter of 2013. As compared to a net loss of $3.4 million or $0.04 per share on both a basic and fully diluted basis for the same period in 2012. Revenues for the third quarter of 2013 were $7.2 million as compared to $578,000 for the same period in 2012. The increase in revenues is primarily due to an increase in license revenue, as a result of the $6 million milestone payment that we earned from Genentech upon the conditional approval of Erivedge by the European Commission in July of this year.

In addition, royalties received from Genentech and Roche's net sales of Erivedge during the third quarter of 2013, also increased to $1.1 million, as compared to $446,000 during Q3 2012. We expect that all, or a significant portion of, our Erivedge royalties will receive by our wholly-owned subsidiary Curis Royalty will be paid to BioPharma II under a December 2012 Erivedge secured loan agreement between BioPharma II and Curis Royalty until the debt is repaid. Curis will retain any royalty revenues in excess of the quarterly caps of $1 million, $2 million, and $3 million in each of 2013, 2014 and 2015. There are no caps after 2015 and Curis will then be entitled to additional royalty revenues following full loan repayment which we currently estimate will occur in early 2017.

Importantly, the remaining patent life on Erivedge composition matter extends through 2028, so there is a very meaningful royalty term left on the compound. Operating expenses for the third quarter of 2013 were $7.1 million as compared to $5.5 million for the same period in 2012. Cost of royalty revenues which are comprised of amounts due to the third-party university patent licensors in connection with Genentech and Roche's Erivedge net sales were $54,000 and $22,000 during the third quarters of 2013 and 2012 respectively. R&D expenses were $4.2 million for the third quarter of 2013 as compared to $3 million for the same period in 2012. The increase was primarily due to $1.9 million in expenses incurred in the development of CUDC-427. We also incurred $300,000 in research and development expenses during the third quarter of 2013 related to the conditional approval of Erivedge in the European Union. Offsetting these increases, we decreased spending on CUDC-101 and discovery research to $420,000 during the third quarter of 2013 from $1.9 million during the same period in 2012, as we shifted our capital resources to the development of CUDC-907, and CUDC-427. G&A expenses were $2.8 million for the third quarter of 2013, as compared to $2.5 million for the same period of 2012. Other expense is $2 million for the third quarter of 2013, as compared to $1.6 million in other income for the same period in 2012. The increase in other expense was primarily the result of approximately $1 million in interest expense and amortization of debt issuance costs related to the loan made by BioPharma II to Curis Royalty. In addition, Curis recognized $1.1 million in other expense during the third quarter of 2013 as a result of an increase in the fair value of a warrant liability. Other income during the third quarter of 2012 primarily represents a change in the fair value of that same warrant liability. During the 3 and 9 months ended September 30, 2013 -- I'm sorry, during the 3 months ended -- during the third quarter of 2013, we sold 2.29 million shares of common stock under an ATM, or at the market sales agreement, resulting in net proceeds to Curis of $9.6 million.

As of September 30, 2013, our cash, cash equivalents, marketable securities and investments totaled $67.1 million, and there were approximately 84.1 million shares of our common stock outstanding. In addition to our cash-on-hand at September 30, in early October 2013, we sold an additional 1.56 million shares of common stock under that same sales agreement, resulting in additional net proceeds to the company of $6.8 million.

Turning to our financial guidance, as a result of the milestone payment on Erivedge as well as the ATM shares, we're increasing our expected year-end cash balance to between $67 million and $70 million. That concludes all prepared remarks. And now, I'd like to turn the call back for Q&A.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from Simos Simeonidis from Cowen and Company.

Simos Simeonidis - Cowen and Company, LLC, Research Division

I was wondering if you can tell us a little more about the patient. Ali, you said she was in the mid-dose cohort, can you tell us the dose? Can you also tell us how many days she was on the drug. How quickly the ALT, AST elevation happened? And also, was she on a lot of prior therapies, and any potential issues that you think could have contributed to these liver enzyme elevations and potentially to her disease or the prior therapies?

Ali Fattaey

Yes, Simos. First, again I'd like to thank our employees and directors, investors and partners for their continued support. With response to your question, obviously, we are going through all parameters related to this patient's course of disease, and her adverse events. So, as we've indicated in there, she was enrolled in the mid-dose cohort. That's the extent of the discussion that we're having at the moment. With regards to analyses that we are conducting for this patient, as well as all patients that have been treated with CUDC-427 includes, obviously their exposure in pharmacokinetics, all concomitant medications, and other parameters, regarding either the patient-specific, their disease, and as I mentioned, the pharmacokinetics of the drug that may contribute to the course of her disease. That's the extent of the announcements that we are, at the moment, conducting and we will be sharing those with the FDA as well.

Simos Simeonidis - Cowen and Company, LLC, Research Division

So, what is that mid-dose. When you said mid-dose cohort, I'm sorry I'm not aware about the different doses, what is the mid-dose?

Ali Fattaey

Sure. Patients were enrolled in this study. 9 patients were enrolled at the -- and it's a standard Phase I escalation design that the study was being conducted on there -- or is being conducted on there. The doses are 200 milligram BID, 300 milligram BID, or 400 milligram BID.

Simos Simeonidis - Cowen and Company, LLC, Research Division

So she was in the 300 mg BID dose?

Ali Fattaey

Correct.

Simos Simeonidis - Cowen and Company, LLC, Research Division

And can you tell us how many days she was treated before?

Ali Fattaey

At the moment we're, as we said we're evaluating all this information, we did receive a notification yesterday from the FDA. So, allow us to go through all of the analysis of this patient as well as all other patients who've been treated with CUDC-427 for that analysis and providing the information to the FDA as well.

Simos Simeonidis - Cowen and Company, LLC, Research Division

You received the notification of the clinical hold, but do you -- but the patient has been discontinued for a month, correctly -- correct?

Ali Fattaey

That is correct.

Simos Simeonidis - Cowen and Company, LLC, Research Division

Okay. And so have you spoken with the FDA about potential plans? I know this is a continuous dosing regimen and I know in the Phase I trial, Genentech had a 2 weeks on/1 week off, this could potentially be a way to develop a drug and maybe -- have you talked about this with the agency?

Ali Fattaey

So as we outlined in the prepared remarks for you. The FDA has requested additional information and analysis of patients treated with CUDC-427. As well as submission of a amended protocol that will take into account factors to mitigate risk to patients, and provide any additional safety as well as considering other trial parameters that contribute to that. What you described is also obviously things that we are analyzing -- this the 2 studies, the Genentech study, as you indicated was conducted under a slightly different schedule of administration versus this one, we are evaluating data to see whether there are correlations associated with that. No conclusions at this point till the analyses is complete -- are completed.

Operator

Our next question comes from Ted Tenthoff from Piper Jaffray.

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

I'm not sure if this was answered in Simos' myriad of questions, but how quickly do you think you'll be able to submit data package to the FDA? And what kind of meeting would a lifting of the partial clinical hold require?

Daniel R. Passeri

Ted. The request from the FDA, and the communication with the FDA outlined our partial clinical hold. At this point, where no new patients can be enrolled, the request is for additional data and analyses of all patients treated with CUDC-427, and submission of the amended protocol for enrollment of new patients into this. We have as I indicated begun these analyses, as well as consideration of what other parameters in the trial we may modify in order to submit that to the FDA. We are obviously taking this seriously and want to analyze the information both for the submission to the FDA, but also to provide us with a better path for CUDC-427 for its future development as well. No timelines at the moment in terms of when the submission may occur, but this is a priority for the organization obviously and we are going through the data analysis at this point.

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

Well, I appreciate that. On to a happier subject, it looked like Erivedge sales actually ticked up, and if my calculation is correct, maybe as high as $21.6 million. What were sales of Erivedge in the quarter?

Michael P. Gray

You're about right. They are around $20 million, $21.5 million, just under $21.5 million.

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

Okay. And then, just Mike, since I have you, one quick clarification. You said there were 84.1 million shares out at the end of the quarter?

Michael P. Gray

Right.

Edward A. Tenthoff - Piper Jaffray Companies, Research Division

So, on September 30.

Michael P. Gray

On September 30.

Operator

Our next question comes from Adnan Butt from RBC.

Adnan S. Butt - RBC Capital Markets, LLC, Research Division

2 quick questions here. First, can you please reiterate what if any AST, ALT liver elevations you've seen in prior studies both from this 9-patient study as well as the Roche, Genentech study? So you saw elevations before and then discontinued? And then the second question is how uniform were AST and ALT elevations in this particular trial? And, were patients discontinued or dose reduced and what are the plans for the capecitabine study?

Ali Fattaey

Adnan. We had indicated and presented at the ASCO conference that 2 patients in the Genentech-sponsored study had grade 3 adverse events related to CUDC-427 that were AST and ALT liver enzyme elevations. In those cases, both of those patients' liver enzyme levels reduced back down to normal levels. This patient, that unfortunately died in our trial, her liver enzymes as well as her bilirubin were unique. Bilirubin levels were unique in that they did not return back to normal on discontinuation of CUDC-427 in this regard. AST/ALT levels in the totality of the patients that have been treated are not a common adverse event, as indicated again in the presentation from Genentech as well. So for all patients that have had CUDC-427-related AST/ALT liver enzyme increases, the difference has been in the -- all other cases, the liver enzyme levels do return to normal upon discontinuation of CUDC-427 whereas for this patient it did not. With regards to the development plan, and additional trials of CUDC-427, as I indicated, upon submission and acceptance by the FDA of the additional information that we'll provide, and the amended protocol for this particular study, this monotherapy study to allow us to reinitiate new patient enrollment, our current plans for development of CUDC-427 as monotherapy and combination therapy, at the moment remain the same, unchanged.

Operator

Our next question comes from Joe Pantginis from Roth Capital.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

When you look at the unfortunate aspects of this patient, I guess, I'd like to focus on the fact that this patient had very, very extensive metastatic disease at multiple sites, including the liver. So when you look at typical disease progression in these cancer patients, do you feel that these liver metastases might have been a contributor?

Ali Fattaey

All analyses at the moment can be considered for understanding the course of this patient's disease, as you indicate, and I apologize, I think there was a question earlier, as well which I did not mention. All patients that are enrolled in this phase of this trial, the dose escalation phase of this study, are relapse refractory patients that have had multiple prior rounds of treatment prior to enrolling into our study. This patient's disease, as you indicated, was a metastatic disease that had spread to her lungs, bone, liver and to her ovaries. We are analyzing in the context of all patients treated whether the sites of disease and the extent of disease, can be a contributing factor to this, as well as looking at other all contributing factors as we indicated drug exposure or pharmacokinetics, concomitant medications and all other parameters are being taken into consideration at this point. All these analyses are being conducted now, and until that is completed and prepared, and ready for submission to the FDA, we do ask that you allow us to do all these analyses and come up with a better understanding of the course of this patient's disease.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Sure. And then just my second and last question, has to do with your statement that the patients that discontinued in the study were either from disease progression or -- and the part that I wanted to focus on, was on -- or physician's discretion. So I just wanted to know the factors around the physicians wanting to take the patients off the therapy if it wasn't necessarily progression?

Ali Fattaey

Joe. Regarding the statements, in the release, patients in our trial discontinued treatment in the normal course of their treatment. Patients came off of the study, either from progressive disease, and one patient elected to discontinue and seek other treatment. The reason that we included physician discretion was just to be inclusive of other reasons beyond safety, that patients would have discontinued the study.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Okay, understood. Hope this is only a temporary glitch.

Operator

Our next question comes from Brian Skorney from Robert Baird.

Brian P. Skorney - Robert W. Baird & Co. Incorporated, Research Division

So I'm just wondering in regards to 427. When we look -- I understand its still in the early stage of evaluating this patient, but when we look back at the ALT/AST increases in patients in the Genentech study, have you guys looked at all at cytokines? I know there has been some reports that at least in pre-clinical, the liver toxicity from 427 is related to kind of TNF alpha mediation. Do you know if in that study cytokines were monitored, and if they are correlated with liver injury? And maybe do you know if there were TNF alpha elevations in this patient in particular at this point?

Daniel R. Passeri

I think it is, from a scientific perspective, and from both the mechanism of the way that this drug works, as well as the trial that Genentech conducted, evaluation of all parameters, of this drug's mechanism, as we indicated, for example the decrease in cIAP protein levels, which is the target of this drug, decreasing its mechanistic-based, the potential for induction of cytokines including tumor necrosis factor, as well as other cytokines and /or chemokines were also evaluated in the Genentech study. There has not to this point been a direct correlation or a link between those. Obviously, this is one of the other factors that we are evaluating as well as measuring in our study. No conclusions at this point. But, biomarkers and induction of other factors by this drug, which are mechanism-based are areas that we are very closely looking at as well.

Brian P. Skorney - Robert W. Baird & Co. Incorporated, Research Division

And, could you characterize the extent of hepatic involvement of her metastatic disease?

Ali Fattaey

Not, at this point, we have indicated that it had spread to her -- to her liver. So that's the extent of the presentation at this point. The patient was staged prior to enrollment into the study and had metastases in her liver. So at this point, it may be premature to try and discuss the extent of the liver metastases. However, it is one of the factors -- or the disease status for the patients is one of the factors that we are analyzing carefully across all patients.

Brian P. Skorney - Robert W. Baird & Co. Incorporated, Research Division

Got you. And then just looking at 907, I was wondering if you could kind of provide a little more insight into where you're characterizing as clinical benefit that you are observing in some patients, are these stable diseases at this point? Or have there been any actual RECIST responses? Or these [ph] protein responses and myeloma? Any color on that would be great.

Daniel R. Passeri

In the past, we have indicated that 2 of the patients that we entered early on into the study have had disease stabilization. Those are continuing patients into our study at this point and continue to benefit from it. In the interest of the fact that in approximately one month, we will be presenting data from this trial at the ASH conference, we really refer you to attend the ASH and we'll present all of the clinical benefit data, safety data as well as analysis of the pharmacokinetics and exposure of patients with this drug from the 3 different dosing regimens at this point. Clinical benefit continues to be observed in this study.

Operator

[Operator Instructions] Our next question comes from Brian Klein with Stifel.

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

So first on the elevated LFTs that were seen in the Genentech-sponsored Phase I, were those patients also -- did they also have liver metastases?

Ali Fattaey

Patients that have had -- of all patients that have been treated with CUD-7, several patients have had liver metastases, including some of the patients that we indicated have had AST/ALT increases. Brian, at this point, I don’t think we're drawing a direct correlation between liver metastases or liver involvement of disease and AST/ALT increase at this point.

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

Okay. And then in the 8 other patients that were treated in your Phase I study, did you see any signs of efficacy?

Ali Fattaey

That has not -- we've not really had a full analysis of the clinical benefit associated with patients in this study. I can say that one patient has had disease stabilization in it, but the full analysis has not been completed. So, potential clinical benefit has been observed with one stable disease in this study as well.

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

Okay. Even with a partial clinical hold, are those 8 patients continuing on therapy or has dosing being completely halted?

Ali Fattaey

We indicated the partial clinical hold that FDA has communicated with us, indicates that we cannot enroll any new patients into the study. In the press release, we also indicated that, at this point, there are no patients in the study being treated with CUDC-427, and that patients had discontinued or have discontinued in the normal course of their treatment including progressive disease, and as I mentioned, one patient, electing to discontinue treatment and seek other treatment.

Brian P. Skorney - Robert W. Baird & Co. Incorporated, Research Division

Great. And then maybe just a question for Mike. In terms of the at the market sales, can you tell us how much is remaining under that allowance?

Michael P. Gray

It is about $13 million.

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

Is that shares or dollars?

Michael P. Gray

Dollars.

Operator

Our next question comes from the Gene Mack with Brean Capital.

Unknown Analyst

This is Dan Brimson [ph] in for Gene. Give you guys a break on 427 for a second. You said you have the data for the operable BCC in hand, and are reviewing it. When do you think you'll be top lining that data? You said you're going to be presenting in a meeting next year, but when do you think you'll have the top line out?

Michael P. Gray

Actually just to clarify, this is Mike. Roche and Genentech have that data and are analyzing it right now. And their expectation -- the expectation is that they'll present the data from that study in Q1 next year, at AAD, a major Derm conference in the U.S.

Unknown Analyst

Okay. But no top line is going to come out before that?

Michael P. Gray

No.

Operator

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

Daniel R. Passeri

We want to thank everyone for your attention and continued support of the company. And we continue to strive to create significant value for shareholders and we look forward to giving you updates as they become available. Thank you, again.

Operator

Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone, have a great day.

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