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spk02: Ladies and gentlemen, thank you for standing by. Welcome to the Uncanova Therapeutics First Quarter 2022 Financial Results and Business Update conference call. At this time, all participants are on a listen-only mode. Following management's prepared remarks, we open to ask a question at that time. Please press star followed by one on your touchtone phone. If anyone has any difficulties hearing the conference, please press star zero for operator assistance. As a reminder, this call is being recorded today, May 11, 2022. At this time, I'd like to turn the call over to Avi Oller, Senior Vice President of Corporate Development and General Counsel.
spk03: Thank you, Operator, and welcome everyone to Ancanova's first quarter 2022 Financial Results and Business Update conference call. Earlier this afternoon, we issued a press release reporting our financial results and business progress. If you have not yet seen this press release, it is available in the Investors and Media section of our website at www.ancanova.com. Today's call will begin with our President and CEO, Dr. Steve Fruchman, providing an overview of our recent progress in corporate strategy. Dr. Fruchman will then ask our Chief Medical Officer, Dr. Mark Gelder, to review our clinical programs. Our CFO, Mark Guerin, will then report our first quarter financial results before we move on to a question and answer session. Before turning the call over to Steve, I'd like to remind everyone that statements made by management during this conference call will include forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially. Forward-looking statements speak only as of the date they are made, as the underlying facts and circumstances may change, except as required by law. Ankenova disclaims any obligation to update these forward-looking statements to reflect future information events or circumstances. For more information on forward-looking statements, please review the disclaimer in today's press release and the risk factors in the company's S&T filings. With that, it is my pleasure to turn the call over to Steve.
spk04: Thank you, Avi, and good afternoon, everyone. Our clinical programs continued to make strong progress over the past months as we efficiently executed on the corporate strategy we've spoken about on our past earnings calls. This strategy has us internally focused on our neurazacycline program while leveraging relationships thought leaders from industry and academia to continue the development of RegoCertib through investigative-sponsored studies based on the mechanism of action of RegoCertib to target cancer indications of interest. As many listening may recall, Nerazacycline is an orally available, multi-targeted, kinase inhibitor. It has a low nanomolar affinity for CDK4 and 6 and other kinases that play important roles in tumor cell proliferation, metastasis, and survival. It can also stimulate anti-cancer immunity through the inhibition of the CSF1 receptor. and disrupt several pathways linked to the described mechanisms of drug resistance for this class of drugs. We believe this inhibitory profile positions nerazacycline to be a highly differentiated and potentially a best-in-class therapy, and we look forward to the publication of an abstract at the upcoming ASCO 2022 meeting that describes this topic further. Currently, two ongoing phase one trials are evaluating nerazacycline in patients with solid tumors. These trials are collectively designed to inform the development of later stage studies and also seek to begin clinically demonstrating the advantages of neurazocyclips differentiated pharmacologic profile. Dr. Mark Gelder will be speaking about these studies in more depth. So for now, I'll just remind everyone that they evaluate both a continuous dosing schedule and a three weeks on, one week off schedule. These dosing regimens mimic the drug administration schemes for those of the FDA-approved CDK4 and 6 inhibitors. I'm pleased to say today that each of Nuragic's Phase I trials remains on track and that we expect to identify the optimal recommended phase two dose in the second half of this year. As these trials continue to progress, the indications and treatment regimens we plan to pursue in later stage studies are coming into focus. While it would be premature to talk about the specifics of these studies before they are finalized, I will say now that indications such as hormone receptor positive, HER2 negative breast cancer, multiple myeloma, and mantle cell lymphoma among those in addition to others that are drawing our interest. This interest is based both on preclinical data and the fact that hormone receptor positive HER2 negative breast cancer is the only indication in which CDK4-6 inhibitors are currently FDA approved. But with the knowledge of the unfortunate reality that resisted to the currently approved drugs are very commonly seen. Shifting gears, I'll now briefly mention that some high-level updates on regocertib, which targets the RAS and PLK1 pathways. Regocertib also acts as an immune modulator due to its ability to generate novel antigens on cancer cell membranes, which promotes the infiltration of autologous T cells into the tumor microenvironment and thus recognize the cancer cells as foreign. And they have the opportunity to thus control their proliferation. There are currently two investigated sponsored studies of regocertib ongoing, with a third expected to begin by the end of June. Two of these studies seek to leverage regocertib's immunomodulatory effects by examining it in combination with a PD-1 checkpoint inhibitor. Last year, we reported preliminary data from the first of these studies, which is in KRAS mutated non-small cell lung cancer. These data were highly encouraging as we observed responses with different KRAS mutations who had failed prior checkpoint inhibitor therapies. This finding differentiates regocertum from other approved KRAS targeted agents since responses are seen in different KRAS mutations and thus demonstrates RegoSERTA's potential to be both KRAS mutation independent and to also overcome the mechanisms driving checkpoint inhibitor resistance in KRAS mutated non-small cell lung cancer. We look forward to the continued progress of this trial and we expect to report additional data at a major medical meeting by the end of this year. We expect the second trial of the RegoCertib checkpoint inhibitor combination therapy to begin later this quarter. This study will enroll patients with metastatic melanoma who are refractory to checkpoint blockade. I'm pleased to report today that the FDA recently approved this trial to proceed after reviewing its design, which Dr. Mark Gelder will speak about shortly. In addition to the ongoing and planned investigative sponsored studies I just mentioned, regocertib is also being evaluated as a monotherapy in an investigator-sponsored study in recessive dystrophic epidermolysis bullosa, also known as R-DEV, complicated by squamous cell carcinoma of the skin. Unlike the two combination studies I mentioned, this trial seeks to take advantage of RegoCert's ability to potently inhibit the PLK1 pathway. On our last earnings call, I discussed some very exciting initial data from the trial which showed a durable, complete response. of over a year in an extensively pretreated patient with R-deb and metastatic refractory squamous cell carcinoma who remains in complete remission today. Though single patient data must always be viewed with caution, it's important to realize that RDEB-associated squamous cell carcinoma is an ultra-rare disease that tragically is invariably fatal. Additionally, we think these initial data could have an important read through into several more prevalent squamous cell indications, which is a concept that Mark Gelder will discuss in a few moments. However, before Mark begins his contribution to today's call, I'd like to first extend my thanks to those responsible for the progress we will be discussing. This includes all of our shareholders, employees, partners, and investigators. Of course, most importantly, this list also includes the brave patients who participated in our clinical trials as well as their families. It's the unmet needs of patients that inspire the Ankanova team as we work to develop our clinical programs based on expert science. With that, I'll now turn the call over to Mark Gelder. Mark?
spk07: Thank you, Steve, and good afternoon, everyone. It is my pleasure to provide an update on our recent clinical progress and future plans, starting with a discussion of our lead neurazocyclic program. As Steve mentioned, Neurazacyclib is currently being advanced in two complementary phase one dose escalation studies in patients with solid tumors, one in the United States and one in China, where we are collaborating with Hanix Biopharmaceuticals. The U.S. trial is evaluating a continuous daily dosing schedule in patients with advanced solid tumors. Enrollment remains ongoing in this trial's fourth cohort, which is evaluating a 160 milligram dose of nerazacycline administered orally each day. The safety findings coming out of this study continue to be very promising, as we have not observed any dose-limiting toxicities or clinically meaningful cases of neutropenia, although we are beginning to see anticipated on-target effects. If the final data from our U.S. study confirm neurazocyclib's favorable safety profile with daily dosing, it will provide an important point of differentiation between neurazocyclib and the approved CDK4-6 inhibitors, Talbocyclob and Ribocyclob. Due to their associated bone marrow toxicity that leads to neutropenia, these two drugs are administered with a three-week on, one-week off dosing schedule to allow time for bone marrow recovery. We believe that avoiding an interrupted dosing schedule with nirazacycline could potentially contribute to enhanced efficacy. Alongside our progress in the U.S., we have also seen nirazacycline phase one trial in China proceeding as planned. The study continues to enroll patients into its fifth cohort, which is evaluating a 200 milligram oral dose of nerazacycline administered each day with a three-week-on, one-week-off dosing schedule. Given the favorable safety data seen in this trial to date, Hanix is currently preparing a protocol amendment that will allow for continued dose escalation. Thanks to the progress we've made in both of NeurasaCyclib's Phase I dose escalation programs, we remain on track to identify a recommended Phase II dose later this year. Looking ahead, we expect to utilize this dose in future trials, including a Phase II basket study enrolling patients with various cancers such as CDK4-6 inhibitor refractory hormone receptor positive HER2 negative metastatic breast cancer. Our planned future trials also include studies that will be designed to evaluate neurazocyclin alone and in combination with other anti-cancer agents in indications where CDK4-6 inhibitors are not currently approved. Before moving on from our discussion of neurazocyclic, I'd like to briefly highlight the robust preclinical dataset supporting our development plans. Some key aspects of this dataset include results suggesting neurazocyclics potently inhibit CDK2, which is essential to DNA replication and one of several reported drivers of resistance to the currently available CDK4-6 inhibitor therapies. Additionally, nerazacyclic has been shown to inhibit ARK5, also known as NUAC1, which is a kinase that promotes cancer cell survival in hypoxic microenvironments and serves an important role in cell adhesion and metastasis. As Steve mentioned, norazacyclib also has strong affinity for the CSF1 receptor, the inhibition of which leads to activation of an anti-cancer immune response. Beyond data on norazacyclib's inhibitory activities, our preclinical data set also includes results indicating that it can suppress the growth of cancer cell lines that are resistant to palvocyclib, which is currently the most widely prescribed CDK4-6 inhibitor. Additionally, we are also highly encouraged by more recently generated in vitro data, which shows neurazocyclib killing breast cancer cells that lack the retinoblastoma gene. This is a significant finding, as the expression of retinoblastoma protein is critical to the anti-cancer activity of the current CDK4-6 inhibitors, and mutation of the retinoblastoma gene is another resistance pathway. Therefore, we believe these results further position to be studied in areas beyond those where palbocyclid and other anti-CDK4-6 therapies are currently approved, as well as in patients resistant to currently approved CDK4-6 inhibitors. I also mentioned that nerazocyclid was shown to cause less bone marrow toxicity than palbocyclid in murine studies. As mentioned earlier, it's pelvic cyclops association with bone marrow toxicity that necessitates its three-week on, one-week off dosing schedule. Collectively, these preclinical findings support our enthusiasm for neurazocyclops development following the identification of the recommended phase two dose. Through the progression of our ongoing and planned trials, we aim to show how Neurasa Cycle's differentiated pharmacologic profile may lead to improved patient outcomes. We look forward to the program's continued advancement and to providing more details on our future clinical plans once they have been finalized. Moving on. I'd now like to speak about Recocertib's investigator-sponsored program, starting with the anti-PD-1 combination studies. Steve mentioned earlier these include an ongoing Phase I-II trial evaluating Recocertib and nivolumab in combination in KRAS-mutated non-small-cell lung cancer and a planned study designed to evaluate regocertib in combination with pembrolizumab in patients with refractory metastatic melanoma. An important point to note about each of these trials is that the inclusion criteria limits their respective patient populations to those who have previously failed therapy with a checkpoint inhibitor. Regocertib's potential to overcome checkpoint inhibitor resistance is supported by previously reported preclinical data highlighting its immunomodulatory effects. These data show regocertib reversing the cold immunosuppressive tumor microenvironments that often underlie checkpoint inhibitor resistance by promoting the expression of novel antigens such as CD40 on cancer cells. This recruits immune effector cells into the tumor, which can then be stimulated by checkpoint inhibitors to mediate cancer cell death. We also have early clinical evidence of regoceratops' ability to overcome checkpoint inhibitor resistance thanks to preliminary data from the non-small cell lung cancer trial I just mentioned. A preliminary update from the trial reported last September showed a 29% overall response rate and a 43% disease control rate. Given that all of the patients enrolled in this trial had previously failed treatment with the standard of care PD-1 checkpoint inhibitor, These data suggest that regocertib may enhance the efficacy of anti-PD-1 therapy and strongly support the activity of the study Dublin. I should also emphasize a point made earlier, which is that responses were observed in patients with different KRAS mutations. This sets regocertib apart from other approved KRAS agents. designed to only target patients with a particular K-RAS mutation, such as G12C. Since our last update, the trial's dose expansion phase has continued to enroll patients. While data from prior patients has been maturing, we expect to provide updated results from the trial later this year. An additional study that will evaluate the same regocertib nivolumab doublet but with potentially higher doses of regocertib is also being considered since we have yet to reach a maximum tolerated dose in the current trial. Moving on, the second investigator-sponsored trial I'll speak about today is the upcoming study designed to evaluate regocertin in combination with the anti-PD-1 antibody pembrolizumab in advanced metastatic melanoma. As mentioned earlier, this trial will also exclusively enroll patients who have failed prior checkpoint inhibitor therapy. There is a pressing unmet need in this population, as approximately half of metastatic melanoma patients lack effective treatment options after progressing on a checkpoint inhibitor. This is a quite frequent occurrence in the syndication as 40 to 60% of metastatic melanoma patients will show acquired or primary resistance to PD-1 inhibition. To attempt to address this need, we and the investigator sponsoring the trial will be collaborating on an open-label, two-stage, single-arm Phase II study. The primary endpoint of the trial will be overall response rate, while key secondary endpoints will include progression-free survival, overall survival, and biomarker assessments intended to shed light on regocertib's ability to remodel the tumor microenvironment. If pre-specified response criteria are met during the first stage of the trial, the study will proceed to stage two where additional patients will be enrolled. The design of the study was recently approved by the FDA and is now awaiting IRB approval at the academic center where it will be conducted. We expect this to occur later this quarter which will allow the trial to open for enrollment. The last investigator-sponsored study I'll mention today is the ongoing trial evaluating regocerted monotherapy in the R-DEV-associated squamous cell carcinoma, which has shown a durable, complete response in a heavily pretreated patient. Since we spoke about the background of this trial, and its initial data on our last earnings call. Today, I will focus on what we believe these data mean from a broader perspective. Let me start by quickly recapping the scientific rationale behind this trial. RdEV is caused by a lack of type 7 collagen protein, which leads to extreme skin fragility and chronic wound formation. Over time, many R-DEV patients developed squamous cell carcinoma with the overexpression of the protein PLK1. This led the trial's investigator, who is one of the world's leading experts on R-DEV, to run a drug screen for inhibitors of PLK1. Of all of the agents tested in this extensive screen, regocertib was found to be the most potent inhibitor of PLK1, suggesting it may have activity against cancer driven by PLK1 overexpression. With the observed complete response in the ongoing investigator sponsored trial, we now have clinical proof of concept supporting this hypothesis. Given the wide array of cancers with PLK1 overexpression, we believe these recent proof-of-concept data highlight regocertum's potential to address unmet needs beyond just R-DEV-associated squamous cell carcinoma. The recent data is now driving conversations with key opinion leaders interested in additional investigator-sponsored studies in more prevalent indications, such as other subtypes of squamous cell carcinoma. In parallel, the ongoing trial in our dead patients continues to advance. Lastly, I'd like to once again emphasize that regoceratibs clinical development will be pursued primarily through investigator-sponsored studies and that we plan to continue dedicating our internal resources primarily through the RAS assignment. With that, I'll now let Mark begin his discussion of our recent financial results.
spk01: Thank you, Mark, and thanks to everyone who's joined today's call. I'm pleased to say that Ankenova remains in a strong financial position. As of March 31st, 2022, the company had cash and cash equivalents of $50.8 million compared to $55.1 million as of December 31st, 2021. Based on our current projections, we believe our current cash position will be sufficient to fund our ongoing clinical trials and business operations, including the pursuit of corporate development opportunities, for more than 18 months. This runway is expected to take us through the achievement of multiple important milestones. Turning now to a review of our first quarter financial results. Research and development expenses for the first quarter of 2022 were $2 million compared to $1.9 million for the first quarter of 2021. General and administrative expenses for the first quarter of 2022 were $2.2 million, and this compares with $2.2 million for the first quarter of 2021. We reported a net loss for the first quarter of 2022 of $4.1 million, or 20 cents per share on 20.9 million weighted average shares outstanding. This compares with a net loss for the first quarter of 2021 of 4.7 million or 32 cents per share on 14.6 million weighted common shares outstanding. This completes my financial review. I'll now turn the call back over to Steve to provide a summary of our anticipated milestones before we move on to Q&A.
spk04: As always, Thank you, Mark. We expect to achieve several important clinical milestones over the upcoming months. Starting with neurazacyclib, we remain on track to establish its recommended phase two dose in the second half of this year. This would then enable the subsequent initiation of a phase two basket trial and a number of important indications, including hormone receptor positive, HER2 negative, refractory metastatic breast cancer. Beyond the RAS acyclic, we expect the investigator-sponsored trial evaluating regocertib-prevalizumab combination therapy in melanoma to open for enrollment later this quarter. We also expect the continued advancement of the ongoing phase 1 slash 2A trial of regocertib plus nivolumab in advanced KRAS mutated non-small cell lung cancer. Updated data from this study are expected with great anticipation by year's end. Finally, we continue to assess opportunities to potentially expand our pipeline through strategic licensing and collaborations. With regards to these efforts, I will emphasize two points. First, any action here will be data-driven based on the science and market size underlying the opportunity. Second, we intend to take a highly selective approach in these efforts as we continue to have very strong conviction around the therapeutic and commercial potential of our current assets. With that, we will now open the call for questions. Operator?
spk02: Ladies and gentlemen, if you wish to register for a question for today's question and answer session, you will need to start on the number one on your telephone. If your question has been answered, you wish to withdraw your request, you may do by pressing the pound key. If you're using a speakerphone, please pick up a handset before entering your request. One moment for our first question. Our first question comes from Charles Zhu of Guggenheim.
spk08: Good evening, everyone, and thanks for taking the question. Regarding CDK4-6 inhibition, to what extent is neutropenia an on-target effect, and do you need to observe neutropenia in order to also see a therapeutic effect associated with your inhibitor? Thank you.
spk04: Mark Gelder, would you like to take that?
spk07: Sure. And thank you for the question. So neutropenia is, and quote unquote, aren't on target effect of CDK4-6, particularly CDK6 inhibitors. If you look at the phase one data from Palbo, Ribo, and Abiracycline, you'll see that neutropenia was the dose-limiting toxicity, or DLT, associated with both pulvocyclib and ribocyclib. And it was really the neutropenia that was responsible for the ultimate dose selected to move forward in their phase two and three clinical trials, and it was also responsible for the necessity of a three-week-on, one-week-off, Abimacyclib, also a very potent CDK4-6 inhibitor, also has some associated neutropenia. But if you look at the Phase I data with abimacyclib, diarrhea was their primary DLT. And because they had some neutropenia, but it was not actually the dose-limiting toxicity, and the neutropenia that was observed did not necessitate a three-week-on, one-week-off dose schedule. Abimacyclob has a continuous daily dosing. So do we anticipate seeing some neutropenia as we continue with our dose escalation? Absolutely we do. We will not be surprised at all. We expect it. Based on our preclinical data, do we think that the neutropenia associated with the rasocyclib will be as severe or profound as that with pulvocyclib or ribocyclib? No, we do not. And what do we anticipate will be the DLT associated with the rasocyclib? You know, we don't really know yet what our quote-unquote DLT will be. We have not seen a DLT in our study here in the U.S. But do we anticipate we will see some neutropenia? Yes, we do. Am I hopeful? Are we all hopeful that the neutropenia will not dissipate a three-week-on, one-week-off schedule? but the jury is still out.
spk08: Got it. Great. Thanks for that color and detail.
spk02: Our next question comes from Mahoud Damir with Leidenberg.
spk06: Hello, team. Thank you very much for taking my question. My question will be on Naraza Cyclic as well. I'm curious to hear what is the extent of preclinical models we are expecting to see at ASCO? Any additional color would be much appreciated.
spk04: I'll ask Dr. Gelder again to take that, Mark.
spk07: So we submitted an abstract to ASCO describing the kinase inhibitory profile associated with neurazacyclin. We did not submit an abstract that describes any of its activity in terms of preclinical models such as PDX or xenograft data.
spk06: That's helpful. My follow-up question will be again on Naraza's CICLIP. How many active sites is currently open and do you plan to open additional sites? Curious on the enrollment status. I'm sorry, I joined late. I hope I'm not asking something you already covered.
spk07: Mark, Yes. So, again, thank you for the question. In our phase one study here in the U.S., we have three active phase one sites who have all been enrolling very well. And do we anticipate opening additional sites for the dose escalation, the phase one dose escalation study? No, we do not. As we open additional studies as part of the basket trial once we achieve the recommended phase two dose. Will we open additional sites for the basket studies? Absolutely we will, yes.
spk06: That's helpful. My last question will be, are there any rational combinational strategies you could use to pair it with noresteclip? Are you considering any of those? even the safety profile has to match, of course. But just curious if there are any rational matches with Narasimha.
spk07: Mark? Yes. So, again, thank you for the question. Great question. And I think that, you know, if you look at where the currently approved CDK-46s, where their approval is, i.e., hormone receptor positive HER2 negative metastatic breast cancer. And you look at the combination therapies employed with the three approved agents, i.e. either aromatase inhibitors, SIRDs, et cetera. We will be doing combination studies with one or more aromatase inhibitors. We'll be doing combination studies with one or more SIRDs. We will We are also planning some additional combination studies that we think make very good mechanistic sense, and we will be outlining those in the future. But, yes, we are planning combination studies with at least two other, if not more, anti-cancer agents.
spk04: Great. Thank you very much. And just to give Mark or Gelder a break, as you know, mantle cell, based on the mechanism of action of durazocyclic, and as we mentioned, is of great interest to us, and based on the anticipated profile and perhaps some preclinical studies planned, drugs like ibrutinib in mantle cell are the standard of care, so we could anticipate looking at combinations with the typical anti-mantel cell drugs used, such as ibrutinib as well.
spk06: Very helpful. Thank you very much. I appreciate you taking my questions.
spk02: Our next question comes from Joe Payne. Again, it's with AC Wainwright.
spk05: Hey, guys. Good afternoon. Thanks for taking the question and the details today. So sticking with the RAS a little bit, obviously, You know, everything we're discussing today is the completely classical route, and, you know, you're going to identify the RP2D in the second half. So I wanted to ask my question this way. With all the initiatives at FDA, how are you going to look to reconcile, if that's the right word, the initiatives with the FDA to identify the minimal effective dose?
spk04: Well, I tried to give Mark a break, but I can't. So, Dr. Gelder, would you like to handle that? Sure.
spk07: So what I can tell you is that we have recently completed and finalized a protocol amendment for the ongoing phase one dose escalation study where we are going to incorporate a PD, pharmacodynamic marker, so that we will not only be looking at the safety profile with each dose escalation, but we will also be looking with the PD marker, and this will allow us not only to identify the quote-unquote NTD or maximally tolerated dose, but also a dose where we achieve maximal biologic effect based on the PD marker. So that protocol amendment has been finalized, has been signed, and the amendment has been sent to the three sites for submission to their IRB, has been submitted to the FDA as well.
spk05: Okay. And so talking about markers, that's a good segue for my next question. I guess, you know, earlier in your prepared comments when you talked about on-target effects that you're seeing already, and, of course, you already had the discussion about neutropenia, any other details about what other on-target effects you are seeing and how you're measuring them?
spk04: Go ahead, Mark, please.
spk07: So the other on-target effects that we're seeing are, again, primarily related to bone marrow and bone marrow precursors. And so looking at hematocrit, hemoglobin levels, looking at platelet counts, again, looking at white blood cell counts, et cetera. So we are This is primarily through looking at different laboratory values, and the CBC is the most sensitive indicator of CDK6 inhibition.
spk05: Got it. And then my last question, just switching gears, thanks for the patience. When you look at the potential for a Phase II in R-DEV, Obviously, there's no standard of care, really. And I was just wondering, at this point, could you take any broad strokes as to the design or size of this study? One would guess that it wouldn't be that big.
spk04: Well, I'll take that. I think, actually, Joe, it could be tiny. This is such an ultra-rad disease, 100 patients. New patients are reported per year in the U.S. Most of them die, unfortunately, of wounds. and infections before they develop squamous cell carcinoma. But the fact that we have one complete remission, the rate limiting step in my view is to get more patients because of the alternate rare nature of the disease. I don't think we would have to do a controlled, Phase 2 trial, I think if we have a few more patients, we have the dose, we know the dose, a few more patients on the current trial, if responses are seen, the plan would be to go directly to the FDA to ask for approval in this rare indication based on the response rate observed and how durable the response has been to date. So that would be our plan. get a few more patients, hope for as robust a response as we've seen to date, and then go to the FDA with our data and have a discussion with the FDA about an approval or what next steps would it take to get such an employee.
spk05: Got it. Thanks a lot, and looking forward to the updates later this year.
spk02: Our next question comes from Robert LaVoyer with Noble Capital Markets.
spk09: I'm opposed to giving Dr. Gelber a break, so I'd like to ask a question about the Rigocertib trial that's coming up. Based on the discussion earlier, it sounds as if you're going to do a competent trial of Rigocertib with Keytruda in metastatic melanoma, and this is going to start with a phase using a single arm in a single center and then go to a second stage with additional patients. Could you... elaborate as much as you could on the number of patients, treatment time, and time for data or starting the second phase? Sure.
spk07: Steve, do you want me to handle that or do you want to go?
spk04: No, no, please, Robert. It has good taste and it sounds like he prefers you. So go ahead, Mark, please.
spk07: So the study is going to be conducted. It's a phase two study, a phase one, two study. It's going to be conducted at a single academic center that has a very high volume melanoma patient population. It will, the inclusion criteria are such that all patients will have been required to have failed prior to checkpoint inhibitor therapy. And by that I mean progress on prior therapy. It's not going to include patients who are intolerant because this is a combination of regoceratib and pembrolizumab. And in stage one, there will be 10 patients enrolled. If a certain response rate is met as defined in the protocol, It will then progress on to stage two. Currently, stage two will take place at the same institution. They feel confident that they have a very adequate patient population to enroll this trial quickly. The stage two we'll enroll an additional approximately 20 patients. And, you know, if all goes well and as planned, and looking at the volumes that they do have, we do believe that they can meet the enrollment targets. But if all goes well, we should have data from the first stage by the first part of next year. We believe that we will have stage one fully enrolled by the end of the year and that we should have some response data the first part of next year. Remember, the primary endpoint is response rate per resist. And so it's going to take a minimum of two cycles. Some patients may have responses early, i.e. after one or two cycles. But it may be that we don't see responses in other patients until three or four cycles. So we don't anticipate having results of the first stage until the first part of next year.
spk09: Great. Thank you very much.
spk07: But this is a This is going to be conducted at an academic center with a very high volume of melanoma.
spk02: I'm showing no further questions in the queue. At this time, I'd like to turn the call back to the speakers for any closing remarks.
spk04: Thank you, Operator. I'd like to once again thank all of those participating today and for your very insightful questions. We are excited about our recent progress and look forward to the continued execution of our corporate and clinical plans as outlined today. Please stay safe and have a nice evening and take care.
spk02: Ladies and gentlemen, thank you for your participation in today's conference call. This concludes the event. You may now disconnect.
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