Q4 2022 Celcuity Inc Earnings Call
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Speaker 2: Welcome to CellQUT's full year 2022 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please contact the
Speaker 2: please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Robert Ewell with ICR Westwick. Thank you, Robert. You may begin. Thank you, operator, and good afternoon to everyone on the call.
Speaker 3: Thank you for joining us to review Cellcuity's fourth quarter and full year 2022 financial results and business update.
Speaker 3: Earlier today, Salcuity released financial results for the fourth quarter and full year ending December 31, 2022. The press release can be found on the investor section of the website.
Speaker 3: Joining me on the call today are Brian Sullivan, Cellcurity's Chief Executive Officer and co-founder, Vicki Hahn, Chief Financial Officer, as well as Igor Gorbachevsky, Chief Medical Officer, who will be available during Q&A.
Speaker 3: Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in the forward-looking statement.
Speaker 3: These non-grant measurements are used by management to make strategic decisions, forecast future results, and evaluate the company's current performance.
Speaker 3: Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future.
Speaker 3: You can find the table reconciling the non-GAAP financial measures to GAAP measures in today's press release.
Speaker 3: And with that, I would now like to turn the call over to Brian Sullivan, CEO of Cellcuity. Please go ahead.
Speaker 4: Thank you, Robert, and good afternoon, everyone. We had an eventful and productive 2022. Our primary goal for the year was to begin enrollment of our Phase 3, Victoria 1 clinical trial for our lead candidate, Gitta Tulliset.
Speaker 4: This trial is enrolling patients with advanced states are positive her 2 negative breast cancer whose disease progressed after treatment with a CDK 46 inhibitor
Speaker 4: We began 22 working with the USFDA and the European Medicines Agency.
Speaker 4: to finalize feedback on our clinical trial protocol. Once we received this feedback, we finalized our protocol and then completed selection of over 200 clinical trial sites across five continents to participate in the study.
Speaker 4: These sites include some of the world's leading breast cancer institutions.
Speaker 4: After formally activating the study in the third quarter,
Speaker 4: We were very pleased to dose our first patient this past December .
Speaker 4: The dosing of the first patient in the Victoria I clinical trial triggered the closing of a $100 million private placement and drawdown of a $20 million term loan tranche in December .
Speaker 4: Proceeds from the private placement, combined with the debt facility and the company's current cash, cash equivalents and marketable securities
Speaker 4: are expected to be sufficient to fund Salchuity's current operating plan through 2025.
Speaker 4: So far, we are very encouraged by the activity at our Victoria I trial sites. We remain on track with our prior guidance and continue to expect data for the PIK3CA non-mutated patient subgroup to be available in the second half of 24 and data for the PIK3CA mutated patient subgroup to be available in the first half of 25.
Speaker 4: The scientific rationale for launching the Victoria I study was predicated on two key factors. First, there's a significant unmet need for better second-line therapeutic options for HR positive, HER2-negative breast cancer patients who received prior CDK46 inhibitors.
Speaker 4: Current therapeutic options offer only modest, progression-free survival benefits. Try friendly Candide
Speaker 4: We reported very promising results from our phase 1B study that evaluated gadotyl acid plus polycycline combined with either Lactazol or Flovesa.
Speaker 5: Thank you.
Speaker 4: For patients lacking.
Speaker 4: PIK3CA mutations. Published data for approved second line therapies indicate they only offer median PFS of two to four months.
Speaker 4: for patients who have picked 3CA mutations, the published data for median PFS of approved therapies is approximately 7 months.
Speaker 4: The clinical efficacy data we initially reported in 2021 from our Phase 1 view study compares very favorably to these published results.
Speaker 4: We've since updated our data to reflect 13 months of additional follow-up, and we presented this data in a spotlight poster presentation at the 2022 San Antonio Breast Cancer Symposium in December .
Speaker 4: Updates included efficacy results broken out for patient subgroups according to PIK3CA mutation status in each of the four expansion arms.
Speaker 4: For the patients in RMD of the phase 1
Speaker 4: for the patients in RMD of the phase 1B study.
Speaker 4: Those who received the Phase 3 dosing schedule have got to listen.
Speaker 4: The ORR, or objective response rate, was 60% in PIK3CA wild type patients, and the percentage of patients who were progression-free at 12 months was 49%.
Speaker 4: These results compare very favorably to published data for Flovestrin, the control drug for PIK3CA wild-type patients in our Victoria I study.
Speaker 4: In a recent randomized study, Flovestrin reported an objective response rate of 6% and a 12-month PFS rate of 12% for Flovestrin.
Speaker 4: For the RMD patients who had PIK3CA mutations...
Speaker 4: the objective response rate was 73% and in 12 months PFS rate was 60%.
Speaker 4: Again, these results compare very favorably to published results for the Alpalypsobin Flovestrin regimen, the control for PIK3CA-mutated patients in the Victoria I study. In two clinical trials, the objective response rate for Alpalypsoid plus Flovestrin averaged 20%, and the 12-month PFS rate averaged 25%. The comparable objective response rates for PIK3CA-mutated patients were
Speaker 4: and 12 month PFS rate and the PIK3 is a wild type and mutated patient subgroups is driven by…
Speaker 4: We believe two key factors.
Speaker 4: First, a victory.
Speaker 4: mTOR pathway is a driver in HR-positive breast cancer regardless of whether the patient's tumor has an activating PIK3CA mutation or not.
Speaker 4: And second, inhibiting the four class I PIK3CA mutations or isoforms and the two mTOR complexes is required to most efficaciously address PI3K mTOR pathway activity. This is the optimal approach biologically because it avoids the cross-activation of uninhibited subunits and resulting drug resistance.
Speaker 4: that can occur with PI3K isoform specific or mTOR specific inhibitors.
Speaker 4: Completely blockating the pathway also enhances the potential to induce synergistic inhibition with other targeted therapies such as CDK46 inhibitors. Gettosyllisib's differentiated mechanism of action as an equipotent panps3KM-torn inhibitor. Thus uniquely suits we believe.
Speaker 4: to address the need for more effective second-line breast cancer therapies.
Speaker 4: We believe this data and the unmet need we are seeking to address play the key role in the FDA's decision to grant breakthrough therapy designation in July last year to get a list of combination with public sick living for best room for the treatment of HR positive for two negative advanced breast cancer. We were also very encouraged.
Speaker 4: by the updated efficacy results for the 41 patients in our phase 1B study who had not received prior treatment for advanced disease.
Speaker 4: These patients received GEDA-solicitin combined with polycyclaben-lectrozole as first-line treatment.
Speaker 4: In the combined group of treatment-naive patients from escalation Arm A and expansion Arm A, the main KFS was 42.3 months and the objective response rate was 79%.
Speaker 4: These results compare very favorably to the median PFS of 24.5 months and 55% objective response rate reported in the PALOMA 3 study for paulocyclib plus...
Speaker 4: Let's resolve.
Speaker 4: Of note is that the median PFS and expansion RMA patients alone was not reached as of the June 22 data cutoff. We will present updated efficacy data for expansion RMA as well as for the combined data for the two arms with treatment naive patients at the ESMO breast cancer meeting in May.
Speaker 4: These results provide another demonstration of the intrinsic role the PI3K mTOR pathway plays as a disease driver in advanced HR positive, HER2 negative breast cancer.
Speaker 4: The data also highlights the potential opportunity to develop Gata-Tilisib as a first-line treatment option.
Speaker 4: While a randomized first-line study evaluating GED-IF elicits combined with Pavluciclid plus Lectrazol is not practical for us to pursue at this time, this promising data certainly warrants evaluation in the future.
Speaker 4: Another important goal for us in 2022 was to begin evaluating and prioritizing new potential indications for GEDF-illicit. This evaluation includes assessment of previous trials for other PS3K and MTOR inhibitors, review of other pathways linked to the PS3K MTOR pathway, and conduct of non-clinical studies to characterize the activity of GEDF-illicit
Speaker 4: plays an essential role in disease recurrence and progression in prostate and gynecological cancers in addition to breast cancer.
Speaker 4: As has been demonstrated in breast cancer, co-targeting the hormonal and P3K AKT-M4 pathways is a promising treatment strategy. But the approach is confounded by the feedback and feed forward loops between P3K isoforms, AKT-N and M4 that cross-activate uninhibited subunits.
Speaker 4: This literature review, as well as considerations of the unmet needs in various tumor types, led us to focus our initial non-clinical research studies on prostate and gynecological cancers.
Speaker 4: We presented the results, first results from our studies, which focused on prostate cancer in February 23 at the American Society of Clinical Oncology Genital Urinary Cancer Symposium.
Speaker 4: We've previously discussed how most PI3K mTOR inhibitors selectively spare or weakly inhibit one or more key PI3K mTOR pathway components and how this can enable drug resistance depending on the mutation status of a patient's tumor.
Speaker 4: In prostate cancer, the P10 gene is linked to PI3K and it is frequently mutated. Inhibitors that only target a single PI3K mTOR component, or AAKT, have demonstrated limited clinical efficacy in PTEN-deficient prostate cancer.
Speaker 4: and no efficacy in P10 wild-type tumors.
Speaker 4: As has been found with breast cancer, this suggests that more comprehensive inhibition of the PSG-M2R pathway may be required.
Speaker 4: We thus posited GEDA-FELICIB as a pan-piesteric mTOR inhibitor would be infected in both P10 wild-type and P10-deficient prostate cancer models.
Speaker 4: We thus positive get a solicit as a PAN PSRKM to our inhibitor would be infected in both P10 wild site and P10 deficient prostate cancer models. To assess the hypothesis...
Speaker 4: We evaluated a panel of prostate cancer cell lines with different P10 status for their sensitivity to get it to elicit, and six other inhibitors that target at least one component of the PI3K-AKT-MTOR pathway.
Speaker 4: The results from these studies were very encouraging and supportive of our hypotheses. Our assessments confirmed that Gedis-Tilicid was the only inhibitor that was as potent in efficacious in PTEN wild type as PTEN-mutated prostate cancer cells.
Speaker 4: In addition, in every assessment, which includes cytotoxicity, potency, cell death, DNA replication and signaling, get us a list of exhibits superior activity relative to all of the other P3K, AKT, or M2R inhibitors evaluated.
Speaker 4: A particular note was the contrast between GEDIS-HELICIB and the AKT inhibitor, CAPIVASTER.
Speaker 4: Capovaceturb has been evaluated in prostate cancer clinical trials, but it has only reported modest efficacy to date in P-10 mutated type tumors and no efficacy in P-10 wild type tumors.
Speaker 4: The results from our non-clinical studies with capovacitor are consistent with these clinical results.
Speaker 4: We found that capovaciturb was tenfold less potent in P10 wild-type than P10 mutated cancer cells and generally inferior to the pan-pieds-brk drugs and much less active than got us illicit.
Speaker 4: We believe these results and the contrast we've got with FELISA provide further demonstration of the importance of comprehensively rather than selectively blockading the PI3K mTOR pathway.
Speaker 4: To assess gettethylysms in vivo activity in prostate cancer, we evaluated gettethylysms in three different prostate cancer malzuna graft models.
Speaker 4: The first evaluated get a philisop as a single agent and P10 wild type and P10 loss the no-craft models that were insensitive to the androgen receptor inhibitor and is a lot of mid.
Speaker 4: In both models, the adults elicit a bit induced more than 80% tumor growth inhibition, whereas endolotimates had no activity.
Speaker 4: We also evaluated a prostate cancer's unigreft model that was sensitive to
Speaker 4: And this model gets a less induced 80% tumor growth inhibition as a single agent and 116% inhibition when it was combined with emzalotamate.
Speaker 4: 80% tumor growth inhibition as a single agent, and 116% inhibition when it was combined with amzalotimate.
Speaker 4: We will present results for our next set of clinical studies at the American Association for Cancer Research annual meeting, which is being held in Orlando, Florida, from April 14th through the 19th.
Speaker 4: These studies evaluated the panel of gynecological cell line models with Gettyslis have been several other Piatric ATM-torn inhibitors.
Speaker 4: In abstract, summarizing this data was published last week. Consistent with our findings in prostate cancer, GEDA-FELICIB exhibited superior activity relative to all of the other PI3K-AKT mTOR inhibitors evaluated.
Speaker 4: Based on the results from these internal non-clinical studies and on gutturalists highly differentiated mechanism of action and PKD profile, we think there is a significant opportunity for us to develop gutturalists in these tumor types.
Speaker 4: We will provide an update on our clinical development priorities later this year.
Speaker 4: Now I would like to shift our discussion to the diagnostic side of our business that centers on Cellc
Speaker 4: As you may recall, the enrollment in the fact of one in fact two trials that are evaluating early stage breast cancer patients selected using our cell signature HER2 signaling diagnostic were impacted by COVID-19 related delays up through early 2022.
Speaker 4: These trials are now enrolling patients with early-stage breast cancer whose HER2 pathway is hyperactive as detected with our Cell Signia test.
Speaker 4: Our goal is to provide our cells Cygnia tests as a companion diagnostic so that pharmaceutical companies can expand the number of patients eligible to receive their targeted therapy.
Speaker 4: We expect to announce interim results from these studies in the second half of 2023. With that, I'll now turn our call over to Vicki Hahn, our CFO , to review our financial results. Thank you, Brian , and good afternoon, everyone. I'll provide a brief overview of our financial results for the fourth quarter and full year 2022.
Speaker 6: And I invite you to review our 10K, which will be filed later today for a more detailed discussion.
Speaker 6: Our 4th quarter net loss was 11.6 million or 69 cents per share compared to 6.8 million net loss or 45 cents per share for the 4th quarter of 2021. Net loss for the full year 2022 was 40.4 million or $2.64 per share.
Speaker 6: compared to $29.6 million net loss or $2.21 cents per share for the same period in 2021.
Speaker 6: For purposes of calculating net loss per share, the reported net loss of $2.64 per share included an additional $2.00 loss per share related to approximately 0.3 million deemed dividend resulting from a warrant modification.
Speaker 6: Because these quarterly and full-year net losses include significant non-cash items, including stack-based compensation, the issuance of common stock and interest, we also include in our press release non-gap adjusted net loss for the quarter.
Speaker 6: and full year ending December 31, 2022.
Speaker 6: Our non-GAAP adjusted net loss was $10.2 million, or $0.60 per share, for the fourth quarter of 2022, compared to non-GAAP adjusted net loss of $5.6 million, or $0.37 per share, for the fourth quarter of 2021.
Speaker 6: Non-Gap Adjusted Net Loss for the full year 2022, with $34.9 million or $2.26 per share, compared to non-Gap Adjusted Net Loss of $21.4 million or $1.60 per share for the full year 2021.
Speaker 6: Research and development expenses were $10.6 million for the fourth quarter of 2022, compared to $5.5 million for the fourth quarter of 2021.
Speaker 6: The increase was primarily the result of activities supporting the initiation of the Victoria I pivotal trial.
Speaker 6: R&D expenses for the full year 2022 were 35.3 million compared to 25.8 million for the prior year. The increase in R&D expenses included a 10 million reduction in Get It To Lissab licensing-related expenses.
Speaker 6: This reduction was offset by increases in other R&D expenses which included employee and consulting expenses.
Speaker 6: as well as increased expenses for existing clinical trials and for activity supporting the initiation of the Victoria I pivotal trial.
Speaker 6: General and administrative expenses were $1 million for the fourth quarter of 2022, compared to $0.8 million for the same period in 2021. G&A expenses for the full year of 2022 were $4.1 million, compared to $2.6 million for the prior year.
Speaker 6: The increases for the fourth quarter and full year 2022 over the same period in 2021 were driven primarily by non-cash stock-based compensation.
Speaker 6: Net cash used in operating activities for the fourth quarter of 2022 was $9.5 million, compared to $6.1 million for the fourth quarter of 2021. This was a result of non-GAAP adjusted net loss of $10.2 million, offset by working capital changes of approximately $0.7 million.
Speaker 6: Net cash used in operating activities for the full year 2022 was 36 million compared to 20.3 million for the full year 2021. This was the result of non-GAAP adjusted net loss of 34.9 million and working capital changes.
Speaker 6: to cash and cash equivalents of $84.3 million on December 31, 2021.
Speaker 6: The 168.6 million does include the net proceeds of 115.2 million from the funding of the pipe and the drawdown of the debt facility.
Speaker 6: $168.6 million does include the net proceeds of $115.2 million from the funding of the pipe and the drawdown of the debt facility. I will now hand the call back to Brian .
Speaker 4: Thank you, Vicki. Operator, could you please open the call for questions. Thank you.
Speaker 2: We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participation using speaker equipment, it may be necessary to pick up your handset before...
Speaker 7: Thanks for taking my questions. For Phase 3 status, I know it's still early days, but I'm wondering if you could talk more about number of sites activated and in what countries and are there any comments on site activation or enrollment trends that you can share at this point?
Speaker 4: So we have a plan, basically at a site level for each site in each country. And we're on track to activating our sites on the schedule that will allow us to essentially be able to report our primary analysis in the second half of 24.
Speaker 7: So far, really nothing to report other than we're on plan. Got it. Okay. And wondering, too, if you can remind me what the Data Safety Monitoring Review Plan looks like for the Phase 3 and will you provide general updates after DSMB reviews?
Speaker 4: Generally, no, that is not public information. Igor, maybe you could shed some light on the IDMC we have and their role in the function.
Speaker 4: Generally, no, that is not public information. Igor, maybe you could shed some light on the IDMC we have and their role and the function. Thank you, Brian .
Speaker 8: As Brian mentioned, a regular update on independent data monitoring committee review is not a standard practice. However, this study includes all of the appropriate steps to monitor data including independent data management committee that includes.
Speaker 8: experts in oncology and statistics. And according to the chartered data will be reviewed starting with the initial patients enrolled in the study and ongoing basis.
Speaker 8: The system has been set in place and IDMC work will proceed as per charter.
Speaker 4: But that IDMC operates independently of the company.
Speaker 7: Okay, and one other specific question I wanted to ask. I see in the Phase 3 as one of the secondary endpoints, you're assessing PFS and OS based on HER2 low status. Just wondering if you can remind me if you looked at HER2 low status in the Phase 1b.
Speaker 4: differentiation and results based on HER2 status. So all the patients were HER2 negative, but whether it was zero, one plus, or two plus.
Speaker 7: Got it. Okay, thanks for taking my questions.
Speaker 7: Okay, thanks for taking my questions. You're welcome.
Speaker 7: Thank you. Our next question is from Alex Novak with Craig Hallam. Please proceed with your question. Okay, great. Good afternoon, everyone. I was hoping the first one just on the staffing up for the clinical trial, just where are you at? Do you think you're at a healthy balance right now? And just how to think about...
Speaker 4: and associated vendors. And so those are internal individuals. We have an organization, the clinical operations organization regulatory that is essentially overseeing and managing that process. That staff has largely been hired and in place.
Speaker 4: The CRO expenses are a function of site activation and enrollment, and you will see as enrollment and number of patients, aggregate number of patients.
Speaker 4: who are receiving treatment will increase over, you know, the next few quarters. Vicki, I don't know if I don't think we've provided, I think the guidance that you have or what you've indicated in your numbers or what has been reported in other forecasts is consistent with our...
Speaker 7: Okay, all right. That makes sense. Then maybe a bit more on the delay with FACTS-1 and 2. It looks like it does dig a push. I think it was MEDL of 2023 that pushed the second half. Just what you're seeing there at the clinical trial sites and then just an update on FACTS-3, 4, and 5 timelines.
Speaker 4: To get a patient enrolled in VAC1 and 2 requires a fair amount of screening. Twenty percent of patients who are, 20% of HER2-negative patients are eligible for our study based on the test results, the patients that are hyperactive HER2 signaling. And so it's somewhat difficult to predict on a month-to-month basis the proportion of patients that qualify for the study as well as just...
Speaker 4: the screening activity. So we had a forecast and it was
Speaker 4: a little optimistic relative to what we're seeing currently. And does that apply to the FAC-3, 4, and 5 then as well? Yes. And the issues, not issues, but the challenges with getting patients enrolled in those studies is that we require a research biopsy. You know, unlike, you know, a Victoria I study, where essentially we're enrolling all comers,
Speaker 4: There's no requirement for anything other than normal standard of care assessments. In the case of the FACTS studies, we require a research biopsy, which may not be standard of care typically isn't, in order to assess.
Speaker 4: their tumor and determine whether their HER2 pathway status is hyperactive or not. And with COVID, that became very, very difficult because patients essentially were not coming in for non-essential or non-standard of care procedures. And so really what we've been working with our sites is to get them back.
Speaker 7: into that essentially pre-screening mode and scheduling these research biopsies for this patient group. Okay. All right. Makes sense. You have casted the readout of Victoria 1, but you also got data which looks like, at least from the preclinical standpoint, that has applicability into non-breast cancer or prostate cancer and so on. Depending on your level setting, trying to manage these two, you would be able to deal with some of the different issues in the post' pe registration process that you're Aviv use114 on your patient group, so as far as trying to really validate whether or not you welcome the correct management problem for the Betsyberry patient group. Two chemotherapy false clarifications teaching the goto chief medical director of Figures with deepSemi clinical trials with 90% good likelihood ace in total groupenser I 3OORay
Speaker 7: How do you, on one hand, put your head down, focus on Victoria enrollment with the cash on hand versus maybe spending a little bit more that puts Victoria enrollment readout with the cash you have on hand at risk, but you can go after these other cancers. How are you thinking about that? Sure. No, that's a great question. When we raised the money last year, we took into account or assumed that we would do a single early phase, you know, phase one, two study in another tumor type. And so we factored that into our cash projections, and so our estimate of cash availability through 25 reflects our hierarchical pieces ofents
Speaker 4: the assumption that we do feel an early phase study in another tumor type. And relative, with respect to obviously keeping our head down, our goal would hope to report favorable data in the second half of 24. We think if...
Speaker 4: in a similar time frame. I'm not projecting a timeline, but I'm just simply saying if we could report in that zip code of time results in another tumor type, we think that would be very accretive to the value of the business because it would demonstrate if the results were successful, favorable.
Speaker 4: it would demonstrate that GATA-Tolistem has the potential not only to be, we think, a potentially standard of care, second line drug. Data suggests we could move UPLINE, or certainly the potential for that, in breast cancer, as well as in other tumor types. And we think that would just highlight the...
Speaker 4: significant value that this drug provides to cancer patients and the resulting value to shareholders. So, you know, we think, you know, there's a fairly long lead time to get that type of data going and we think it's to everybody's advantage if we can, you know, in effect plant the flag in another tumor type and get a perspective on...
Speaker 4: get as activity, which we think if favorable would be very, very valuable to everybody.
Speaker 7: Absolutely, it makes total sense. Thanks for the update. You're welcome. Thank you. Our next question is from Boris Peaker with TDCoHN. Please proceed with your question. Great, thanks. This is Nick on for Boris.
Speaker 7: Just one for me. What data should we be looking for from the fact one and fact two trials that are going to report in the second half that will show that it has a positive effect? Like, what specific endpoints should we be focused on? So the endpoint in those two trials is a pathological complete response.
Speaker 4: rate, which is a measure of whether the tumor has been eliminated in the patient. There's a specific assessment to determine that.
Speaker 4: have a statistical plan that this defines a benchmark that we need to beat in order to determine that we have a potentially significant result that would warrant, A, continuing the study, but also continuing towards additional evaluations.
Speaker 2: Great, thank you. That's it for me. Thank you. Our next question is from Gil Bloom with Needham & Company. Please proceed with your question.
Speaker 7: Hi, this is Rohit on for Gil. Thanks for taking our questions. Can you just talk about any preliminary discussions you might have had with payers and if you've received any feedback on possible pricing dynamics? Thanks.
Speaker 4: We have had discussions with TARE consultants to get some perspective on the landscape. We have in our plan to initiate those kind of conversations as we get closer to the end of the year. But there are fairly well established benchmarks for prices that have been established with novel targeted therapies.
Speaker 4: The CDK46 therapies have been on the market and have an established price that's been supported over time. You know, there's novel SIR that was just approved.
Speaker 4: PS3K drug, Alpalypso or Picre has been approved and established price points. And so our internal assumptions assume, rather internal assumptions when we derive a peak revenue estimate assume that our pricing will be at least comparable to let's say what Picre is obtaining in the marketplace.
Speaker 4: We frankly think if our data is favorable that we will generate a greater clinical benefit for those patients and would certainly warrant at least an equivalent price.
Speaker 4: we frankly think if our data is favorable, that we will generate a greater clinical benefit for those patients and would certainly warrant at least an equivalent price. Thank you.
Speaker 2: Thank you. Our next question is from Sawaiyam Pukula, Ramkant.
Speaker 2: Thank you. Our next question is from Sawaiyampakula Ramkath.
Speaker 8: Sorry, please proceed with your question. Thank you. This is RK from HSC Rainbight. Good afternoon, Brian . Just a quick question. Hello. This is just trying to think beyond Victoria I at this point.
Speaker 9: Certainly this is a study where you're combining with the CDK46 inhibitor. Are there any thoughts in terms of combination with other immune checkpoint inhibitors because that's also being floated as a way to go in breast cancer?
Speaker 4: So immune checkpoint inhibitors to date have been approved in TNBC, triple negative breast cancer. There haven't been successful results in HR-positive, hormonally driven breast cancer, as is the case in prostate cancer. So—
Speaker 4: it appears, or at least to date suggests, that hormonally driven cancers are not responsive to the checkpoint inhibitors. And that certainly...
Speaker 7: is a factor that we take into account as we're considering our development plan. Thank you. Thanks for taking my question. You're welcome. There are no further questions at this time.
Speaker 7: I would like to turn the floor back over to Chief Executive Officer Brian Sullivan for closing comments. Well, thank you again for participating in our call today and for your ongoing support. We'll be participating in the Needham Healthcare Conference in mid-April. Look forward to meeting with many of you there. I hope you have a great evening.
Speaker 2: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Speaker 2: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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