U.S. Markets closed

Edited Transcript of GTXI earnings conference call or presentation 8-Aug-19 9:00pm GMT

Q2 2019 Oncternal Therapeutics Inc Earnings Call

MEMPHIS Aug 20, 2019 (Thomson StreetEvents) -- Edited Transcript of Oncternal Therapeutics Inc earnings conference call or presentation Thursday, August 8, 2019 at 9:00:00pm GMT

TEXT version of Transcript

================================================================================

Corporate Participants

================================================================================

* James B. Breitmeyer

Oncternal Therapeutics, Inc. - President, CEO & Director

* Richard G. Vincent

Oncternal Therapeutics, Inc. - CFO

================================================================================

Conference Call Participants

================================================================================

* Hartaj Singh

Oppenheimer & Co. Inc., Research Division - Research Analyst

* Kumaraguru Raja

Brookline Capital Markets, LLC, Research Division - Director & Senior Biotechnology Analyst

================================================================================

Presentation

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

Greetings, and welcome to Oncternal Therapeutics Q2 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Richard Vincent, Chief Financial Officer. Please go ahead.

--------------------------------------------------------------------------------

Richard G. Vincent, Oncternal Therapeutics, Inc. - CFO [2]

--------------------------------------------------------------------------------

Thank you, operator. Good afternoon, everyone. I'd like to welcome you to our conference call to discuss Oncternal's second quarter financial results and provide an update of our clinical and preclinical development programs.

Earlier today, we issued our earnings release reporting financial results and business updates and plan to file our Form 10-Q for the quarter ended June 30, 2019 with the Securities and Exchange Commission tomorrow. Our filings and a replay of this call will be available on the Investors section of our website at www.oncternal.com for at least the next 30 days.

With me today is Oncternal's President and CEO, Dr. James Breitmeyer. During our call today, Jim will provide an overview of our business and pipeline and an update on recent progress. I will provide a brief summary of our financials for the second quarter ended June 30, 2019. We will conclude with a brief Q&A.

Please note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. I caution listeners that during this call, Oncternal management will be making forward-looking statements about future events and Oncternal's business strategy and future financial and operating performance. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements should be considered in conjunction with and are qualified by the cautionary statements contained in Oncternal's earnings release and SEC filings, including its Form 10-Q for the quarter ended June 30, 2019. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 8, 2019. Oncternal undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

With that, I'll now turn the call over to Jim.

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [3]

--------------------------------------------------------------------------------

Good afternoon, everyone. Thank you for joining our first conference call since we commenced trading on Nasdaq as Oncternal Therapeutics, Inc., under the ticker symbol ONCT. We are proud of the speed and efficiency with which we were able to debut trading on the Nasdaq market through a reverse merger that Rich will describe later in the call. But we're particularly proud of the progress we have continued to make across our product development pipeline by maintaining momentum and focus on clinical development even while the reverse merger was being completed. I'd like to provide some insights into what we've been working on, what we've accomplished and why we at Oncternal are so excited about the potential impact that the drug candidates in our pipeline may have for patients with cancer.

Let me start with an overview of our pipeline, which consists of 2 clinical-stage product candidates and 1 preclinical development program. Each of our product candidates is designed to attack very specific mechanisms that cancer cells use to grow, thrive or metastasize. We have a highly experienced drug development team focused on identifying and developing the best approaches for targeting these novel cancer pathways while minimizing effects on healthy cells. With our drug development expertise and continued collaboration with academic institutions, we are focused on turning important research discoveries into new potential therapies for patients.

Our lead program is cirmtuzumab, a monoclonal antibody designed to inhibit the ROR1, R-O-R-1, receptor, which is currently in a Phase I/II clinical trial in combination with ibrutinib for patients with chronic lymphocytic leukemia, or CLL, and patients with mantle cell lymphoma, or MCL. In addition, cirmtuzumab is in a Phase I clinical trial in combination with paclitaxel for the treatment of patients with metastatic or unresectable breast cancer.

We believe that ROR1 is an important cancer target implicated in tumor genesis, disease progression and treatment resistance. We believe that the combination of cirmtuzumab and ibrutinib may address a serious and important unmet medical need.

Ibrutinib is becoming a standard of care in the modern treatment of patients with CLL and MCL. However, complete responses or CRs are uncommon in patients treated with ibrutinib alone. We believe that an agent that works synergistically with ibrutinib to increase the number of patients achieving a CR without substantial added toxicity is therefore needed and would provide meaningful clinical benefit. And while cirmtuzumab is early in development, we have already seen encouraging responses in our clinical trial in patients with CLL and MCL.

In June, we presented interim data from our ongoing Phase I/II clinical trial of cirmtuzumab at the ASCO annual meeting, demonstrating an overall interim objective response rate of 91.7% for the first 12 patients with CLL treated in Part 1 of the Phase I portion of the study who had received cirmtuzumab in combination with ibrutinib for 24 weeks or more. This included 3 patients with clinical or confirmed complete responses and a well-tolerated safety profile, consistent with that seen for ibrutinib-treated -- treatment alone.

Earlier this week, we were pleased to announce that we have opened for enrollment the randomized Phase II part of this ongoing clinical trial of cirmtuzumab and ibrutinib in patients with CLL triggered by favorable outcomes from the Part 1 dose-finding and Part 2 dose-confirming cohorts, including an observed interim objective response rate of 100% for the first 9 CLL patients with evaluable data receiving the recommended dosing regimen who have completed 12 weeks of cirmtuzumab plus ibrutinib treatment in Part 2. We have continued to see a well-tolerated safety profile in the trial, consistent with that seen with ibrutinib treatment alone.

Included in the results presented at ASCO were preliminary results from 6 patients with mantle cell lymphoma who were treated in a separate cohort of that Phase I/II study. One patient with MCL, who had relapsed following an allogeneic stem cell transplant, experienced a confirmed complete response after 3 months of cirmtuzumab plus ibrutinib treatment, including complete resolution of a large mediastinal mass. This complete response appears to be durable as it has been confirmed after 6, 9 and 11 months of cirmtuzumab plus ibrutinib treatment.

Cirmtuzumab is also being studied in an investigator-initiated Phase I clinical trial in combination with paclitaxel for patients with unresectable or metastatic breast cancer. That study is open and enrolling patients at the University of California, San Diego. Cirmtuzumab was developed at the UC San Diego School of Medicine based on the pioneering scientific research of Dr. Thomas Kipps and his colleagues, and has been supported by grants from the California Institute for Regenerative Medicine, or CIRM, C-I-R-M. We expect to provide additional updates from both cirmtuzumab clinical studies later this year, including results from additional patients with CLL and MCL enrolled in the Phase I portion of our study of cirmtuzumab plus ibrutinib and for patients with breast cancer enrolled in the Phase I study of cirmtuzumab plus paclitaxel.

Our other clinical program is TK216, the first investigational small molecule to enter the clinic that is designed to inhibit the biological activity of ETS or ETS-family transcription factor oncoproteins in a variety of tumor types. Our lead indication for TK216 is Ewing sarcoma, a rare but devastating pediatric bone cancer with few treatment options after first-line chemotherapy. Virtually all cases of Ewing sarcoma express an oncogenic ETS fusion protein that is potentially targeted by TK216. Oncternal has already received an Orphan Drug designation and Fast Track status from the FDA and believes that the program will be eligible for a pediatric voucher.

We are evaluating TK216 alone and in combination with vincristine in a Phase I study in patients with relapsed or refractory Ewing sarcoma. The dose-finding portion of that Phase I study is almost complete, and we expect to select a recommended dosing regimen and begin enrolling an expansion cohort of Ewing sarcoma patients treated with TK216 in the third quarter of 2019.

Our third program is an anti-ROR1 CAR-T therapy, which is in preclinical development in collaboration with UC San Diego. This research has also been supported by grant funding from CIRM. CAR-T therapies are T-cells that have been engineered to bind and engage a specific target on cancer cells in an effort to direct the patient's own immune system to react against those cancer cells. We believe ROR1 is an attractive car -- target for a CAR-T therapy due to its expression across a wide variety of common blood cancers and solid tumors. Our targeting antibodies were designed to bind cancerous cells with high affinity but to not recognize most normal human tissues. Our goal is to select a candidate and initiate clinical trials with our lead CAR-T therapeutic candidate next year.

That concludes my formal comments on our pipeline programs. I'd like to close this business update by saying Oncternal has in its own DNA a number of key traits found in leading biotechnology companies: serial biotech entrepreneurs and drug developers with proven success, a diversified pipeline of oncology drug candidates targeting untapped cancer biology, and emerging clinical data demonstrating potential therapeutic activity. We are proud of the progress Oncternal has made building and advancing its oncology pipeline, and we remain unwavering in our commitment to bring new cancer treatments to patients.

I will now call -- turn the call back to Richard Vincent, CFO of Oncternal, to review second quarter financial results.

--------------------------------------------------------------------------------

Richard G. Vincent, Oncternal Therapeutics, Inc. - CFO [4]

--------------------------------------------------------------------------------

Thank you, Jim. On June 7, 2019, privately held Oncternal Therapeutics completed a reverse merger transaction with GTx, Inc. and its wholly owned merger subsidiary. Under the merger agreement, the merger subsidiary merged with and into private Oncternal, with private Oncternal surviving as a wholly owned subsidiary of the company. The surviving entity changed its corporate name from GTx, Inc. to Oncternal Therapeutics, Inc.

The transaction was accounted for as a reverse asset acquisition in accordance with generally accepted accounting principles. Under this method of accounting, private Oncternal was deemed to be the accounting acquirer for financial reporting purposes. As a result, effective as of the closing date of the merger, the reported historical operating results for periods prior to the merger closing date will be those of private Oncternal. Furthermore, given the growth Oncternal has experienced within the last 12 months, period-over-period comparisons may not be meaningful.

All share and per-share figures for all periods presented reflect either the exchange ratio for private Oncternal shareholders on the one hand, or the 1 per 7 reverse stock split for GTx shareholders on the other hand, both of which occurred immediately prior to the closing of the merger. For more detailed information regarding the reverse merger transaction and our financial results, I invite you to review our quarterly report on Form 10-Q for the quarter ended June 30, 2019, which will be filed tomorrow.

Grant revenue was $0.7 million for the quarter ended June 30, 2019. Our grant revenue is derived from a CIRM grant subaward with the University of California, San Diego. The grant was awarded to advance our lead clinical program in a Phase I/II clinical trial evaluating cirmtuzumab in combination with ibrutinib for the treatment of patients with B-cell lymphoid malignancies, including CLL and MCL.

Total operating expenses for the quarter were $22.3 million, which included a onetime noncash charge for acquired in-process research and development expenses of $18.1 million that was recorded in connection with the closing of the merger. Research and development expenses for the quarter totaled $2.6 million. General and administrative expenses for the quarter totaled $1.6 million.

Including the onetime merger charge, the net loss for the second quarter was $22.8 million or a loss of $3.38 per share basic and diluted. As of June 30, 2019, we had $28.5 million in cash and cash equivalents. We believe these funds will be sufficient to fund our operations into the second quarter of 2020. As of June 30, 2019, we had 15.4 million shares of common stock outstanding.

That concludes the financial discussion. With that, let's open the call for questions. Operator?

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) Our first question today is from Hartaj Singh of Oppenheimer.

--------------------------------------------------------------------------------

Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [2]

--------------------------------------------------------------------------------

Great. Congratulations on your first call. I just have a few, guys, if you don't mind. So congratulations on finishing up the first Part 1 and Part 2 of your Phase I/II, and then already starting the Phase II part of the study with the 90 patients. Can you just talk a little bit about -- it looks like you'll randomize 90 patients there with CLL, receive either ibrutinib or ibrutinib plus cirmtuzumab. Can you just talk a little bit about the kind of -- the way the cohorts are set up? And then what -- I know, I guess the primary end point will be complete response. But just what are you thinking about how the cohorts are set up? And then how will you sort of report data as it kind of comes out? Or will you wait until you get to the 90 patients before reporting data? And I just got a couple of follow-up

questions.

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [3]

--------------------------------------------------------------------------------

Thank you for your question, Hartaj. So let me clarify. You're asking about the way that the randomized portion of the study is composed?

--------------------------------------------------------------------------------

Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [4]

--------------------------------------------------------------------------------

Correct, correct. Just wondering as you start this Phase II, sort of just what the structure looks like and how those cohorts are structured. And then just what are the primary and then secondary end points you're looking for?

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [5]

--------------------------------------------------------------------------------

Thank you. Thanks for the clarification. So the randomized portion of our Phase I/II study, the Phase II portion, will be composed of 90 patients, all with CLL, and they will be randomized 2:1 to receive either cirmtuzumab plus ibrutinib and -- on the one arm and ibrutinib alone on the other hand. So the cirmtuzumab dose was selected during the Parts 1 and 2, the Phase I portion of the study. And that is -- it's a 600-milligram dose given once a month after a couple of loading doses at the at the beginning.

Now you'll also realize -- so that's the randomized portion. The -- you'll realize that the earlier parts of the study, Part 1 and 2, are also ongoing. And we've had such encouraging results from that part of the study that we have just amended it to permit patients who are responding after 1 year on the study to continue to receive treatment. The study is open label and -- but there's only one specified interim analysis during the randomized portion of the study.

--------------------------------------------------------------------------------

Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [6]

--------------------------------------------------------------------------------

Great. That actually helps a lot. Now one -- another question I have is that just looking for your 2:1 randomization, if for your 2 -- your combo arm versus your mono arm, what's the sorter for complete response? What's the kind of the bogey you're looking for, the delta between the 2? And then I assumed that -- is that just coming from sort of the previous experience with ibrutinib? Or I imagine it's in the public domain with just the complete response that ibrutinib tends to give in this patient population.

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [7]

--------------------------------------------------------------------------------

Yes. Yes, it is. Thank you for that question. The expected response rate for patients with CLL who have relapsed or refractory disease to ibrutinib is generally reported to be less than 10% and in fact, most commonly in the range of 6% to 7%. So the study is powered to detect a difference in complete response rate of about 25% between the 2 arms of the study.

--------------------------------------------------------------------------------

Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [8]

--------------------------------------------------------------------------------

Great. Fantastic. So that is really now. If you're Phase II with the 90 patients, which is an interesting design, is there some -- a result, I guess, that could get you in front of the regulators and might even lead to sort of an accelerated kind of approval? I mean are you going to be seeing relapsed/refractory patients or other kind of patient types? Or where the data, if it's compelling enough and you see that 25% or bettering of the complete response, whereby you could get to market sooner? Or you think you'd still have to do probably a Phase III in order to get to market?

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [9]

--------------------------------------------------------------------------------

That's a very good question, Hartaj. And we do believe that sufficiently robust outcomes emerging from the study would be worth taking to regulators and discussing with them the potential of an accelerated approval strategy.

--------------------------------------------------------------------------------

Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [10]

--------------------------------------------------------------------------------

Yes. Okay, that helps a lot. And then just -- I just had a couple of like follow-up questions. One is how are you getting the supply for ibrutinib? Is that -- are you sort of purchasing that on the open market? Or are you -- how are you getting the ibrutinib for these trials?

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [11]

--------------------------------------------------------------------------------

Thank you. The ibrutinib is being provided free of cost to the patients through a very generous product donation and supply agreement that the company has established with Pharmacyclics. We are very grateful to Pharmacyclics for supporting this study. And in fact, upon a recent review of the data that we've disclosed this week, Pharmacyclics agreed to expand this product donation. And our -- and we have their commitment to provide the ibrutinib for the entire study now, that means including the entire randomized portion of the study. And with their support, we are providing ibrutinib free of cost to patients who are responding well after a year on the clinical trial to continue their ibrutinib and cirmtuzumab treatment.

--------------------------------------------------------------------------------

Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [12]

--------------------------------------------------------------------------------

Great. No, that's fantastic. And is there any option that Pharmacyclics has to sort of support the trial more than the ibrutinib donation? I mean can they also sort of make an agreement with you with -- to help run the trial? Or will that be dependent on a full agreement that they might have to sign within Oncternal if they were to go down that path?

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [13]

--------------------------------------------------------------------------------

That would require an additional agreement to expand in the direction that you're suggesting.

--------------------------------------------------------------------------------

Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [14]

--------------------------------------------------------------------------------

Got it. And then just my last question, which is on the ROR1 CAR-T program. Cirmtuzumab is -- hits that target. How much of your understanding for (inaudible) biology kind of helped you with the CAR-T and the design of the CAR-T in going after that target?

And then secondly, how would the CAR-T kind of play against cirmtuzumab in the future? Are you just going to go after different tumor types with the CAR-T? Or you see them sort of one coming before the other.

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [15]

--------------------------------------------------------------------------------

Thank you very much for good questions, Hartaj. We appreciate your interest in our programs. So the CAR-T questions fall into 2 categories. The first one is, what is it that we know about ROR1 that helped us to design a CAR-T project that we thought would be an important addition to the field? And I'll address that in a couple of ways. One is that ROR1 expression does identify particularly aggressive subpopulations of a number of different kinds of cancer, from lung cancer to liver cancer to the hematologic malignancies. Secondly, and this is largely due to the pioneering research of Dr. Kipps at UCSD but has been confirmed in other laboratories, when ROR1 is expressed on a tumor cell, that tumor cell has adverse characteristics such as an increased proliferation rate, an increased tendency to invade and potentially, resistance to certain forms of therapy. So in other words, we're targeting a bad actor in a ROR1-expressing tumor cell. We've also had, through our collaboration with Dr. Kipps, a very deep depth of knowledge around the ROR1 antibodies themselves. And the targeting antibodies that we're using have been studied extensively and do not recognize most adult normal tissues.

And the antibody -- the ROR1 antibody really matters in this case. And what I mean by that is that there are other published ROR1 antibodies that have been in laboratory testing. None have ever -- none other has ever reached the clinic, but other antibodies have been shown to cross-react with normal tissues in a way that complicates their development as product candidates. So I think that the -- those are the key features that we knew about ROR1 that have led us to develop the CAR-T system that we are intending to take forward.

Your second question is also a good one. And that is we're developing an antibody and a CAR-T. So the development of the antibody has a particular emerging set of facts that we're paying careful attention to, is that the cirmtuzumab antibody has a safety profile that indicates that it is very well tolerated. I mean specifically that in a Phase I monotherapy study, that there were few, if any, serious adverse events that were attributed to treatment with the cirmtuzumab antibody. The infusions are well tolerated, and the side effects that we're seeing in the Phase I study were typical of those -- of patients with CLL.

In the ongoing Phase I/II clinical trial, the safety profile that we are observing is one that is characteristic of patients with CLL who are receiving ibrutinib alone. And there have not been any discontinuations or serious adverse events that have been attributed to treatment with cirmtuzumab. So the antibody will have, we think, particular utility in patients who desire, along with their physicians, added efficacy without the risk of substantial added toxicity.

The CAR-T program may be a little different in that respect. And I'm sure you know that most CAR-T systems are associated with a certain level of side effects as the immune system is activated to attack the cancer. And sometimes, those side effects can be severe. So we're considering. We haven't selected our clinical targets yet, but we're considering clinical targets such as B-cell ALL, Richter syndrome or aggressive non-Hodgkin's lymphoma where ROR1 expression is known to be common and the patients require a higher degree of efficacy. And we believe that they and their physicians may be willing to accept the potential of more side effects to get there.

So I think I answered both halves of your questions. Let me check back with you and see if I did.

--------------------------------------------------------------------------------

Hartaj Singh, Oppenheimer & Co. Inc., Research Division - Research Analyst [16]

--------------------------------------------------------------------------------

No. That's fantastic. That makes a lot of sense. And then is it just with the CAR-T? Because I assume it's an autologous CAR-T that you kind of neatly sidestep some of the issues that have probably hamstrung some of the previous antibodies with ROR1. So in this case, you're looking for a bigger gun, but you're using the patient's own cells to be able to go after those ROR1-expressing cells.

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [17]

--------------------------------------------------------------------------------

Yes, that's right. And so for example, the bluebird scientists did some preclinical work with a ROR1 CAR-T system, utilizing an antibody that cross-reacted with the lung tissue of the mice that they were using for their experimental system. And they observed some substantial toxicities in preclinical studies.

--------------------------------------------------------------------------------

Operator [18]

--------------------------------------------------------------------------------

(Operator Instructions) Our next question is from Kumar Raja of Brookline Capital Markets.

--------------------------------------------------------------------------------

Kumaraguru Raja, Brookline Capital Markets, LLC, Research Division - Director & Senior Biotechnology Analyst [19]

--------------------------------------------------------------------------------

So what can you share with regard to the ROR1 cell surface expression so far? And also, what are you seeing in terms of the response to the correlation with the plasma concentration of the drug?

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [20]

--------------------------------------------------------------------------------

Thank you for the question, Kumar. So as far as ROR1 expression is concerned, we have confirmed that every patient that has been tested in the study has ROR1 expressed on their CLL cells. The mantle cell patients are a little harder to test because they don't have circulating tumor cells. The -- and we use a receptor occupancy assay and confirm that the antibody that we are administering is, in fact, coating ROR1 expressed on the surface of the patient's CLL cells.

As far as a correlation between blood levels and outcomes is concerned, the numbers are pretty small. We had 3 patients in each of our dose-finding cohorts. And we had selected a range in the middle of the doses that had been tested previously in the Phase I single-agent study. We expected all 4 of the doses that we tested to have activity. And in fact, we saw that. We have had solid partial responses at every dose that we tested.

--------------------------------------------------------------------------------

Kumaraguru Raja, Brookline Capital Markets, LLC, Research Division - Director & Senior Biotechnology Analyst [21]

--------------------------------------------------------------------------------

Also, there seems to be some literature which suggests that once patients are treated with ibrutinib, there seems to be increase in ROR1. Obviously, you are blocking both of those. My question comes down to what can you speculate in terms of when you use the combination, what could be the potential resistance mechanisms?

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [22]

--------------------------------------------------------------------------------

Well, it's a great theoretical question. The -- we haven't seen any progressive disease yet in the current Phase I/II study. So I'm sorry to say that we can't study resistance yet. We're not sorry, of course. We're delighted that our patients are responding and are not experiencing progressive disease. So we are -- we'll be interested to study any resistance that develops. And the hypothesis would be that it will take longer. And the value proposition would be that -- that the hope that it might be less likely for resistance to develop to the combination since the 2 agents, cirmtuzumab and ibrutinib, inhibit CLL cell biology through 2 independent mechanisms. And as you remember from preclinical work, ibrutinib shuts down a number of pathways inside the malignant CLL cells, but it does not shut down the ROR1 pathway.

--------------------------------------------------------------------------------

Kumaraguru Raja, Brookline Capital Markets, LLC, Research Division - Director & Senior Biotechnology Analyst [23]

--------------------------------------------------------------------------------

And also in terms of the Phase II, are you going to be expanding the number of sites for that?

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [24]

--------------------------------------------------------------------------------

Yes, we are. We have -- we're open at 10 sites right now, and we'll be -- we're in the process of adding on 5 additional sites at the moment.

--------------------------------------------------------------------------------

Kumaraguru Raja, Brookline Capital Markets, LLC, Research Division - Director & Senior Biotechnology Analyst [25]

--------------------------------------------------------------------------------

So the expectation would be that probably, we will have like a quick enrollment.

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [26]

--------------------------------------------------------------------------------

Could you repeat the question?

--------------------------------------------------------------------------------

Kumaraguru Raja, Brookline Capital Markets, LLC, Research Division - Director & Senior Biotechnology Analyst [27]

--------------------------------------------------------------------------------

In terms of enrollment, the expectation would be that we can see a very quick enrollment in the Phase II portion?

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [28]

--------------------------------------------------------------------------------

Well, we're not guiding on the amount of time to complete enrollment yet. We have just opened the randomized part of the study. But I will say that we have a good level of enthusiasm among our investigators for the results that we have seen so far.

--------------------------------------------------------------------------------

Operator [29]

--------------------------------------------------------------------------------

There are no additional questions at this time. I would like to turn the call back over to Dr. Breitmeyer for closing remarks.

--------------------------------------------------------------------------------

James B. Breitmeyer, Oncternal Therapeutics, Inc. - President, CEO & Director [30]

--------------------------------------------------------------------------------

Thank you very much, operator. Everybody, thank you for joining us for Oncternal's first quarterly earnings call as a Nasdaq-listed company. Oncternal has a diversified pipeline based on cutting-edge science. We have strong management and a Board composed of serial biotech entrepreneurs and experienced drug developers. We expect to announce additional data from our ongoing clinical programs later this year and next year, including our randomized Phase II study of cirmtuzumab in combination with ibrutinib. We realize that we have a lot of work ahead and are sharply focused on turning our promising science into progress and hope for patients with cancer. Thank you for joining us today.

--------------------------------------------------------------------------------

Operator [31]

--------------------------------------------------------------------------------

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.