Q1 2024 MacroGenics Inc Earnings Call
Yeah.
Good afternoon.
Speaker Change: We will begin the Macrogenics 2024 first quarter corporate progress and financial results conference call in just a moment.
Speaker Change: All participants are in listen only mode at the moment and we will conduct a question and answer session at the conclusion of the call.
At this point I will turn the call over to Jim Carroll's Senior Vice President Chief Financial Officer of Macrogenics.
Sure.
Jim Carroll: Thank you operator, good afternoon, and welcome to Macrogenics conference call to discuss our first quarter 2024 financial and operational results.
Jim Carroll: For anyone who has not had the chance to review. These results we issued a press release. This afternoon outlining today's announcements. This release is available under the investors tab on our website at Macrogenics Dot com.
Jim Carroll: You May also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately two hours after the call is completed.
Jim Carroll: I would like to alert listeners that todays discussion will include statements about the company's future expectations plans and prospects that constitute forward looking statements for purposes of the safe Harbor provision under the private Securities Litigation Reform Act of 995 actually.
Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factors section of our annual quarterly and current reports filed with the SEC.
Jim Carroll: In addition, any forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date, while we may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if our views change except to the extent required by applicable law.
And now I'd like to turn the call over to Dr. Scott Koenig, President and Chief Executive Officer of Macrogenics.
Scott Koenig: Thank you Jim I'd like to welcome everyone participating via conference call and webcast today I will provide key updates on our clinical programs, including an important interim data update.
Speaker Change: Tamarac Phase III study this afternoon.
Scott Koenig: Before I do so let me first turn the call back to Jim who will review our financial results.
Jim Carroll: Thank you Scott This afternoon Macrogenics reported financial results for the quarter ended March 31, 2024, which highlight our financial position.
Jim Carroll: As described in our release this afternoon Macrogenics total revenue was $9 1 million for the quarter ended March 31, 2024, compared to total revenue of $24 5 million for the quarter ended March 31, 2023. This decrease was primarily due to a decrease in revenue from collaborative and other agreements, including a $15 million milestone.
Scott Koenig: <unk> received from insight in the quarter ended March 31 2023.
Scott Koenig: Our research and development expenses were $46 million for the quarter ended March 31, 2024, compared to $45 9 million for the quarter ended March 31 2023 or.
Scott Koenig: Our selling general and administrative expenses were $14 7 million for the quarter ended March 31, 2024, compared to $13 5 million for the quarter ended March 31, 2023. The increase was primarily related to increased stock based compensation expense and consulting fees.
Scott Koenig: Our net loss was $52 2 million for the quarter ended March 31, 2024, compared to a net loss of $38 million for the quarter ended March 31, 2023 or.
Scott Koenig: Our cash cash equivalents in marketable securities balance as of March 31, 2024 was $184 2 million compared to $229 8 million as of December 31, 2023. Finally in terms of our cash runway consistent with our prior guidance, we anticipate that our cash cash equivalents in marketable securities balance.
Scott Koenig: $184 2 million as of March 31, 2024. In addition to projected anticipated future payments from partners and product revenues should provide a cash runway into 2026.
Scott Koenig: Our anticipated funding requirements reflect expected expenditures related to the ongoing phase II tamarac and market studies as well as our other ongoing clinical and preclinical studies and now I'll turn the call back to Scott.
Scott Koenig: Okay.
Scott Koenig: Thank you Jim.
Scott Koenig: We continue to believe our proprietary pipeline of product candidates has great promise and I will walk you through each of our key programs, including disclosure of new safety and efficacy data from the <unk> study.
Scott Koenig: Albert <unk> in patients with metastatic castration resistant prostate cancer, we have lots to cover today, so let's jump in.
Scott Koenig: Were minimal dual card mozena evolving duo is their ADC designed to deliver a DNA alkylating duo duo <unk> cytotoxic payload to tumors expressing b 783.
Scott Koenig: These seven phase III as a member of the <unk> family of molecules involved in immune regulation.
Scott Koenig: <unk> is designed to take advantage of this antigen is broad expression across multiple solid tumor types.
Scott Koenig: As you know we believe <unk> has the attributes of an ideal cancer target.
Scott Koenig: The <unk> study is being conducted in NFC RPC patients were previously received an androgen receptor axis targeted agents or <unk> and up to one prior taxane containing regimen, but no other chemotherapy agents is.
Scott Koenig: This study is designed to evaluate bumper duo and patients across two experimental arms.
Scott Koenig: Two mix per kg or $2 seven mix per kg every four weeks with radiographic progression free survival or our PFS as the study's primary endpoint.
Scott Koenig: We recently generated an updated expanded interim data set based on.
Scott Koenig: Data cut off date of April 12, 2024, which is the basis for all of the Tamarac data we are sharing with you today.
Scott Koenig: Feel free to download the slide said that highlights this data from the events and presentations page under the Investor Relations section of our website.
Scott Koenig: Or you can find the directly to the document provided in todays earnings press release.
Scott Koenig: Flip ahead to slide four and you will note we have enrolled a total of 181 patients. Although a few patients were on the original control arm.
Scott Koenig: It is not counted in the safety population of 176 patients who receive overdue. This is one less than the 177, we mentioned in an earlier press release as one patient never fully completed the inform consent form process as.
Scott Koenig: As you can see on this slide we've broken out the number of patients with Evaluable, PSA and baseline target lesions by dosing cohort.
Scott Koenig: Slide five provides several baseline characteristics.
Scott Koenig: Both arms are well balanced with the exception of E card status as the $2 78 per kg on very slightly favors <unk> over <unk> zero.
Scott Koenig: Keep in mind that this is a fairly subjective measure.
Scott Koenig: Point out that despite randomization fewer patients in the $2 seven mix per kg cohort and measurable measurable disease than non measurable, whereas there was roughly 50 50 split into two mix per kg cohort.
Scott Koenig: In terms of having a prior taxane versus not the split was close to $60 40 across both dose cohorts.
Scott Koenig: Also recall that.
Scott Koenig: <unk> patients had to have a prior androgen receptor access targeted agents for study entry and as you can see a few had more than one.
Scott Koenig: Next let's review biological activity.
Scott Koenig: On slide six we showed the PSA 50 responses for 153 patients, which represents all subjects, who had received at least one dose of overdue.
Scott Koenig: At a baseline PSA greater than two nanograms per 1000 and had at least one post baseline TSA measurement.
Scott Koenig: For the two dosing cohort, 50% of the 82 evaluable patients experienced a greater than 50% reduction in their PSA, while 43, 9% of patients had a confirmed greater than 50% Psa reduction.
Scott Koenig: And the $2 seven Nic vacate dosing cohort, 57% of 71, evaluable patients experienced a greater than 50% reduction in their Psa.
Scott Koenig: It's 36, 6% of patients had a confirm greater than 50% Psa reduction.
Scott Koenig: I believe these PSA 50 results are generally well aligned with the PSA fit the expectations, we laid out before the study commenced.
Scott Koenig: Turning to the summary of two responses as summarized in slide seven among the 45 patients with baseline target lesion measurements and the two Meg per kg dosing cohort 41, or 91, 1% achieved disease control as measured by some of confirm complete and partial responses, but stay.
Scott Koenig: <unk> disease, while the confirmed objective response rate as measured by some of complete and partial responses or 17, 8% with the inclusion of unconfirmed Crs and Prs the unconfirmed.
Scott Koenig: <unk> was 24, 4%.
Scott Koenig: Among the 32 patients with baseline target lesion measurements in the $2 7000 per gig dosing cohort the disease control rate was 87, 5% the confirmed <unk> was 25% and with the inclusion of unconfirmed Prs.
Scott Koenig: The unconfirmed <unk> was 43, 8%.
Scott Koenig: Let's review the PSA waterfall plots next.
Scott Koenig: Slide eight shows the PSA waterfall plot for the two Meg per kg cohort as you can see 41 of the 82 patients had a 50% or greater decrease in TSA with 36 or 43, 9% of these patients achieved a confirmed PSA response 50 response.
Scott Koenig: Hey.
Scott Koenig: We are still reviewing the center and data at this point the implication is that our <unk> III biomarker diagnostic will likely not be required.
Scott Koenig: Slide nine shows the PSA waterfall plot for the $2 7000 per kit cohort here 36 of the 71 patients had a 50% or greater decrease in TSA with 26 or 36, 6% of these patients achieving a confirmed PSA 50 response.
Scott Koenig: As of the data cut off 39 patients or 54, 9% of patients remained on therapy.
Scott Koenig: Next I will review investigator assess tumor size waterfall plots on.
Scott Koenig: On slide 10, which shows the two Meg per kg cohort of the 45 patients with measurable disease. One did not have a post baseline tumor assessment as I mentioned earlier the disease control rate for this group was 91, 1% with all but three patients having either a partial response or stable disease.
Scott Koenig: Infirmed or was 17, 8%, while the unconfirmed hour was 24, 4%.
Scott Koenig: Slide 11 shows tumor response for the $2 seven Nic per kg cohort here.
Scott Koenig: Of the 32 patients with measurable disease Tuesday, two did not have a post baseline tumor assessment.
Scott Koenig: The disease control rate for this group was 87, 5% the confirmed <unk> was 25%, while the unconfirmed or was 43, 8%.
Scott Koenig: Next I will review the swimmer plot for the tumor response, which will hopefully convey a sense of durability of overdue.
Scott Koenig: The RPC setting.
Scott Koenig: Slide 12 shows the interim results for the two Meg per kg cohort here you can see that about 45% tumor response evaluable patients eight or 17, 8% had confirmed responses with the inclusion of the three unconfirmed responses the unconfirmed or our is 24, 4% 23 of the 45.
Scott Koenig: Patients are 51, 1%, we are still on therapy as of the data cutoff.
Scott Koenig: In the $2 seven per Kid dosing cohort shown on slide 13, eight patients of 25% and confirmed.
Scott Koenig: Objective responses with its six unconfirmed responses the unconfirmed <unk> is 43, 8%.
Scott Koenig: Many of the 32 patients or 62, 5% remained on therapy as of the data cutoff.
Scott Koenig: Next I will review interim safety in the Tamarac study as of the data cutoff.
Scott Koenig: Slide 14 shows the overall summary of adverse events in the study to date.
Scott Koenig: Pointing out a few parameters by dosing cohort.
Scott Koenig: Of the 90 patients who receive overdue ought to mix per kg 89, or 98, 9% experienced a study treatment emergent adverse events.
Scott Koenig: Any grade 49, or 54, 4% of the patients had a great Rio greater Ta and 10 patients or 11, 1% and an adverse events leading to study drug discontinuation.
Scott Koenig: Of the 86 patients who receive overdue at two seven.
Scott Koenig: Seven mix per gig 86 over 100% experienced a ta of any grade.
Scott Koenig: 44, or <unk> 51, 2% of patients had a greater <unk> or greater.
Scott Koenig: 13 patients or 15, 1% and an AE leading to study drug discontinuation.
Scott Koenig: Also as noted on slide 14 as of the data cutoff date, a total of five sale events occurred as follows one grade flash sale event occurred in the two Meg per kg dosing cohort and acute myocardial infarction, which was not classified as treatment related.
Scott Koenig: For grade five events occurred in the $2 seven liquid kick dosing cohort, which included one cardiac arrest not classified as treatment related and two cases of pneumonitis, which is still being investigated initially assessed as possibly treatment related and.
Scott Koenig: In addition, a patient in a $2 seven Mig per kg dosing cohort at a greater pleural effusion and subsequently died.
Scott Koenig: In terms of specific treatment emerging adverse events, those with incidents greater than or equal to 10% as shown on slide 15.
Scott Koenig: To make for kick dosing cohort the five most common tas of any grade in this dosing cohort included as Cynthia nausea, peripheral edema decreased appetite and fatigue.
Scott Koenig: Of note the incidents of pleural effusion in this cohort was grade one of eight 9% and great to have a 99% there were no grade three or greater events.
Scott Koenig: Also the incidents of palmar plantar or retro Dysesthesia syndrome. In this cohort was a great one of 11, 1% and grade two or four 4% there were no grade three or greater events.
Scott Koenig: The five most common tas of any grade in the $2 seven Meg per kg dosing cohort included Athenian decreased appetite peripheral edema, nausea, and pleural effusion.
Scott Koenig: Note the incidents of pleural effusion in this cohort was grade one of 14.0% grade to a 14.0% and grade three or one 2%.
Scott Koenig: Also the incidence of palmar plantar Richard This is Cesar syndrome in this cohort with grade one of 12, 8% grade two of nine 3% and grade three or one 2%.
Scott Koenig: As visually represented in the butterfly plot on slide 16, all the tas of greater than or equal to 10% are overwhelmingly limited to either grade one or two.
Scott Koenig: Overall, we believe these doses are tolerable with side effects that are manageable also we are very pleased with the biological activity observed in the study as of April 12, 2024 data cutoff with interim data being well aligned with the parameters of success that we laid out at the onset of the study.
Scott Koenig: We achieved our goal of reducing the incidence and severity of both palmar plantar retro. This is these are <unk> fusion in comparison.
Scott Koenig: The most recent data cut off to what we saw in the phase one dose expansion study.
Scott Koenig: We will continue to evaluate the totality of the data, including future radiographic progression free survival or PFS.
Scott Koenig: That is primary endpoint as we considered dose selection of either two or $2 76 per kit.
Scott Koenig: To that end, we are currently undertaking the necessary initial steps to prepare for the potential initiation of a phase III study in <unk> in 2025.
Scott Koenig: Looking ahead, we plan to share updated tamarac safety efficacy and durability data, including our PFS in the second half of 2024 based on a future data cutoff.
Scott Koenig: Also as mentioned on our prior earnings call, we plan to expand the tumor types being evaluated in the tamarac trial and expect to enroll additional patients with non small cell lung cancer small cell lung cancer melanoma squamous cell carcinoma of the head and neck and anal cancer, we expect to initiate dose.
Scott Koenig: These additional cohorts in mid 2024.
Scott Koenig: Recall that we have two other clinical molecules that target be 783. The first <unk> six is an investigational AVC incorporating a novel topoisomerase, one inhibitor based linker payload <unk>, which we licensed from <unk>.
Scott Koenig: Our second additional <unk> III targeted molecule is a novel Susan that an investigational FC optimized monoclonal antibody.
Scott Koenig: I'll walk you through both of these molecules next.
Scott Koenig: <unk> hundred 26 incorporates a linker payload based on exit T can a clinically validated and potent camptothecin.
Scott Koenig: That readily combines with <unk>.
Scott Koenig: Fixes Hydrospace technology.
Scott Koenig: <unk> hundred 26 preclinical data was presented recently at the American Association for Cancer Research annual meeting.
Scott Koenig: In preclinical studies <unk> was shown to have greater potency than <unk> III directed antibody conjugated to direct city can dxd topoisomerase space payload utilized in other ADC.
Scott Koenig: In addition, the Mtc all 26 payload has been shown to be less susceptible to multi drug resistant mechanisms than dxd Sn 38.
Scott Koenig: Also our toxicology study conducted in cinema August monkeys showed that <unk> six was well tolerated at all dose levels tested.
Scott Koenig: Finally, mtc all 26 displayed approximate dose proportional pharmacokinetics in the animal models tested indicating predictable behavior conducive to further clinical development.
Scott Koenig: We recently initiated a phase one dose escalation study of <unk> 26.
Scott Koenig: The variable domain of the molecule targeting <unk> three <unk> six is the same sequence contained in broker duo we view <unk> as a complementary approach to Volvo duo for targeting <unk> 783.
Scott Koenig: More specifically, we believe that having distinct mechanisms of action overdue in MCC 26 may address different cancers tumors stages or be used in combination with ultimate agents or potentially with one another to enhance their clinical utility we remain.
Scott Koenig: Confident in the potential of targeting the <unk> III pathway viewing our total one inhibitor strategy has an additional valuable tool and our therapeutic repertoire.
Scott Koenig: Regarding <unk>, our academic collaborators are enrolling an investigator sponsored randomized translates translation really intense phase II investigator sponsored study of this molecule and up to 219 patients with prostate cancer.
Scott Koenig: The heat study is evaluating the activity of neo adjuvant and Novo Susan that given prior to radical prostatectomy.
Scott Koenig: Men with high risk localized prostate cancer.
Scott Koenig: Eligible patients will undergo a pretreatment prostate biopsy and conventional MSG include.
Scott Koenig: Including <unk> and bone scan as well as PSNH and.
Scott Koenig: And optional prostate MRI as per institutional preferences.
Scott Koenig: Next I'll update you on Laura <unk>, our Bispecific tetravalent PD, one by <unk> Dart molecule.
Scott Koenig: We designed <unk> to have preferential blockade on dual PD, one <unk> four expressing cells such as tumor infiltrating lymphocytes, which are most abundant in the tumor microenvironment.
Scott Koenig: We are enrolling lorikeet study a randomized phase II clinical trial of larger Allomap in combination with Docetaxel versus Docetaxel alone in second line chemotherapy naive <unk> patients.
Scott Koenig: A total of 150 patients are planned to be treated in the two to one randomized study.
Scott Koenig: The current study design includes the primary study endpoint of our PFS.
Scott Koenig: We anticipate completing enrollment of the study this year and expect to provide a lorikeet clinical data update in the first half of 2025.
Scott Koenig: In addition, we continue to enroll patients in the phase <unk> dose escalation study of overdue all in combination with Laura <unk> in patients with advanced solid tumors, we anticipate commencing a dose expansion study of this combination in MCR PC and at least one additional indication in 2024.
Scott Koenig: Next up <unk> 24 is our next generation bi specific CD 123 by <unk> Dart molecule that incorporates a CD three components designed to minimize cytokine release syndrome, while maintaining antitumor side of lytic activity and permitting intermittent dosing through a longer half life.
Scott Koenig: Our phase one dose escalation study of MTS Mgd <unk> 24 is ongoing in patients with CD 123 positive relapsed or refractory hematologic malignancies, including acute myeloid leukemia and Myelodysplastic syndrome.
Scott Koenig: Recall that Gilead has the option to license Mgd of 24 at predefined decision points during the phase one study.
Scott Koenig: In terms of preclinical projects Mtc. All 28 is our second topoisomerase, one inhibitor based ADC incorporating <unk> is novel Linker payload and then Adam <unk> targeting antibody.
Scott Koenig: Adam <unk> as a member of the Addams family of multi functional type one trans membrane proteins that play a role in tumor Genesis in cancer progression and is over expressed in multiple cancers, making in.
Scott Koenig: Active target for cancer treatment.
Scott Koenig: We recently presented Mtc, Oh 28 preclinical data at the ACR annual meeting in April.
Scott Koenig: In preclinical studies <unk> demonstrated specific antitumor activity in in vivo models, representing gastric lung pancreatic colorectal small cell carcinoma of the head and neck and Cholangiocarcinoma.
Scott Koenig: In addition in a non human Primate study <unk> was well tolerated at high dose levels with mild reversible side effects and no ocular toxicity, which is off as a concern with <unk> inhibitor based adcs.
Scott Koenig: These promising preclinical results support the continued investigation of <unk> as a therapeutic option for treating Adam <unk> expressing solid tumors. We are currently anticipating submitting an investigational new drug R&D application for <unk> 28 by the end of this year.
Scott Koenig: Beyond <unk> 'twenty eight we're exploring additional molecules for potential future R&D submission I look forward to telling you more about these additional molecules on future calls.
Scott Koenig: To conclude we believe Macrogenics has the technical development and clinical expertise as well as financial resources to support our vision of developing and delivering life changing medicines to cancer patients.
Speaker Change: We will now be happy to open the call for questions operator.
Speaker Change: If you'd like to ask a question at this time. Please press star one on your Touchtone telephone.
Speaker Change: And your name to be announced.
Speaker Change: To withdraw your question. Please press star one again.
Speaker Change: Please standby, while we compile the Q&A roster.
Speaker Change: Our first question comes from the line of Tara Bancroft with TD Cowen.
Speaker Change: Okay.
Tara A. Bancroft: Hi, good afternoon.
Tara A. Bancroft: Lots of questions here I'm sure but.
Tara A. Bancroft: So looking at the safety it does look somewhat similar.
Tara A. Bancroft: Similar to the phase one now with these two extra cycles versus the abstract so could you elaborate more on what it is that youre seeing as improved in terms of safety with these doses or is it what you are referring to more on the efficacy side and and.
Tara A. Bancroft: How.
Tara A. Bancroft: This looks like quite different from the Amtrak with these just two more median cycles. So could you could you describe more what what happened there.
Speaker Change: Well actually Tara, let me sort of go through the safety first of all on the safety data cut was in January and now we're in a.
Tara A. Bancroft: Greater than three months since.
Tara A. Bancroft: The January.
Tara A. Bancroft: We are first of all.
Tara A. Bancroft: Compared to the phase one data we are now exceeding the mean number of doses that were achieved in the phase one study.
Tara A. Bancroft: And then second third is if you look at the butterfly plot of the Aes.
Tara A. Bancroft: The side effects are overwhelmingly great wanted to manageable with a smattering of grade threes.
Tara A. Bancroft: Concerning new type of side effects has cropped up as you see on the figure on the listings.
Tara A. Bancroft: And this interim dataset.
Tara A. Bancroft: And as you note on both the TSA figures as well as the figures. We included on the targeted lesion seguros. The majority of these individuals are still on studying we're clearly in the phase one they were coming off study.
Tara A. Bancroft: We did a head to head analysis at 16 weeks.
Tara A. Bancroft: All patients that are on tamarac and compared it to the prostate patients on the phase. One study also at 16 weeks and the resultant tamarac dramatically improves for example, specifically.
Tara A. Bancroft: Half the amount of grade threes, and tamarac as compared to the phase one prostate group one core one half to one third of the total of discontinuation and about half of all the reductions and tamarac as compared to the phase one.
Tara A. Bancroft: And only one third to one half sub drug interruptions. So as we have laid out in terms of achieving these would be the phase. One study we are we have.
Tara A. Bancroft: Accomplished what we wanted to achieve.
Tara A. Bancroft: Furthermore, we did some key in comparisons to other prostate stuff.
Tara A. Bancroft: Studies for.
Tara A. Bancroft: For example.
Tara A. Bancroft: Discontinuation rates at a 11% at the two megs or the 15% of the $2 seven Megs. This compares well to a number of other studies for example in.
Tara A. Bancroft: The card studying capacity tax so there was a discontinuation rate of 19, 8%.
Tara A. Bancroft: 921, the Docetaxel arm was 22, 4% and similarly, the combo arm with timber was 29, 2% and then in Trident III.
Tara A. Bancroft: Dosing arm there was 32, 4%. So as you see we're doing quite well there with regard to discontinuation vis vis others and similarly for grade threes.
Tara A. Bancroft: We can compare what we're seeing here.
Tara A. Bancroft: For instance, in the Docetaxel arm and train, 361% Keno 921, 36% and then if you even look at experimental phase one studies in prostate some new targets.
Tara A. Bancroft: We'll look at Amgen steep bye.
Tara A. Bancroft: By CD three it was 55%.
Tara A. Bancroft: And then Daiichi 7300, it was up.
Tara A. Bancroft: 47% and their prostate so all in all again as Ive pointed out while at the same.
Tara A. Bancroft: Safety data.
Tara A. Bancroft: Has accumulated more safety side effects.
Tara A. Bancroft:
Tara A. Bancroft: Believe that these are extremely manageable.
Tara A. Bancroft: In discussions with investigators there.
Tara A. Bancroft: Comfortable with managing these patients and are very encouraged by both the safety and obviously the activity data they've seen to date.
Speaker Change: Okay. Thank you that's super helpful. Thanks.
Tara A. Bancroft: Our next question comes from the line of Jonathan Chang with Leerink partners.
Jonathan Chang: Hi, guys. Thanks for taking my questions.
Jonathan Chang: I guess I'm also just trying to better understand the evolution and the tolerability profile versus the previously submitted abstract.
Jonathan Chang: Is there a time dependency to the Aes or does this evolution reflects something else.
Jonathan Chang: And then second question can providing additional color on the patient deaths and whether or not there are treatment related. Thank you.
Speaker Change: Yes, thanks, so much.
Speaker Change: So again as I started off with a question from Tara.
Speaker Change: Cut off from the safety was.
Speaker Change: As of January beginning of January and.
Speaker Change: We did a comparison.
Speaker Change: Between the original things when prostate data.
Speaker Change: Ah.
Speaker Change: The data that we have as of the January cutoff, we looked at the 95 patients that had reached the 12 weeks. So that was a head to head comparison.
Speaker Change: Sure.
Speaker Change: Where the safety was at that point versus that.
Speaker Change: The phase ones.
Speaker Change: And so as I said before this data.
Speaker Change: Data will continue to accumulate we now have data and safety data on the entire population over that now.
Speaker Change: Greater than three more months of data that is accumulated but again.
Speaker Change: As I reiterated on look at the look at the.
Speaker Change:
Speaker Change: Butterflies part, where we have a very.
Speaker Change: Safety data, that's limited to phase one to quite manageable going forward and as I was pointing out earlier. This is not that different from what has been seen with other adcs as well as other agents that have been approved.
Speaker Change: Stay cancer so.
Speaker Change: That's a summary, there with regard to the patient deaths.
Speaker Change: As pointed out.
Speaker Change: Cardiac death, and a cardiac arrest were not deemed to be.
Speaker Change: Associated with with the drug unrelated.
Speaker Change: The additional cases, two cases of pneumonitis.
Speaker Change: <unk> are being investigated as a sort of real time.
Speaker Change: Patients in the $2 seven.
Speaker Change: Sure.
Speaker Change: What we can say is that.
Speaker Change: Particularly one of these cases was very complicated with other other confounding.
Speaker Change: I'm not a medical matters with this patient, but where it's being further investigated right now so I don't have a further <unk>.
Speaker Change: Decision with regard to <unk>.
Speaker Change: Cause and effect with regard to drug.
Speaker Change: <unk>.
Speaker Change: Similarly, the patient that was deemed with apparel fusion.
Speaker Change: The currency of that deaths occurred more than three months later and again, it's being investigated at this time.
Speaker Change: Got it thanks for taking my questions.
Speaker Change: Yeah.
Speaker Change: Our next question comes from the line of Eagle on a couple of bits with Citi.
Eagle: Hi, guys. This was awestruck Mubarak on for Yigal, Thanks for taking my questions.
Mubarak: For me.
Eagle: I guess on the great five pneumonitis or inside of where you were you surprised that this occurred.
Eagle: Quite recalls pneumonitis had been observed.
Eagle: Signaled previously.
Eagle: And to that end is there a piece of an age through expression in the lungs and are you considering maybe integrating some type of steroid prophylaxis to help prevent pneumonitis moving forward.
Speaker Change: Well again as I as I was indicating that these are still being investigated so the cause and effect with regard to the drug is still.
Eagle: Under investigation, and we have not and in fact, we have not seen.
Eagle: And a large.
Eagle: A large number of patients here any association with pneumonitis and that patient so that again raises.
Eagle: Questions of what is the ultimate cause of these patient sets associated with a pneumonitis.
Eagle: With regard.
Eagle: And I'm just finished I'm sorry, I didn't close the second question, which was expression about the 783 in the lung.
Eagle: Not normally seen in lung we had no long findings in the.
Eagle: Cinema August monkey.
Eagle: A college studies clearly with.
Eagle: Certain activation.
Eagle: You can have certain cells that may have <unk>.
Eagle: Expression of <unk>, III, but its not a normal occurrence.
Speaker Change: Okay. Okay got it and then maybe another.
Speaker Change: The question I mean, how are you thinking about choosing the dose moving forward into phase III.
Speaker Change: So it seems a little confounding it seems like efficacy is balanced on TSA 50, but are ours are a little bit higher at the higher dose, but maybe the safety is a little better at the lower dose. So how are you thinking about that.
Speaker Change: That's exactly the point here is that we're seeing a nice great Asia.
Speaker Change: We believe that we have picked up the correct dosing range to evaluate what will be the optimal dose and so this will be determined.
Speaker Change: When we achieve the our PFS values and the disease control rate values.
Speaker Change: We expect to happen.
Speaker Change: Towards later in the midyear.
Eagle:
Eagle: Stay tuned for that but as we view the data right now.
Eagle: Both doses are potentially.
Eagle: Usable.
Eagle: And further develop a ball going forward.
Speaker Change: With the central data got it thanks very much.
Eagle: Our next question comes from the line of Cadbury Polman with BTG.
Kaveri Pohlman: Hi, Good evening. Thanks for taking my question can you comment on how the efficacy and safety look like in chemo pretreated versus chemo naive patients. If you saw any notable differences here.
Speaker Change: Thank you for that question and I.
Speaker Change: I'm not going to comment on that but what I would say at this point is is that both populations both the chemo naive.
Speaker Change: And the chemo experienced populations are under consideration for development as we go forward into the phase III study.
Speaker Change: And nothing unexpected.
Speaker Change: Was observed with regard to either populations in terms of overall.
Speaker Change: Overall responses.
Speaker Change: Got it and then is there any feedback you received from physicians regarding those reduction interruption great.
Speaker Change: Reduced level.
Speaker Change: That for us and their potential to impact durability.
Speaker Change: Well again as you know.
Speaker Change: We've shown very nicely and we wanted to illustrate that on the swimmers plots.
Speaker Change: These patients had sustained.
Speaker Change: Responses and continued even under the circumstances win.
Speaker Change: Doses had been modified and reduced.
Speaker Change:
Speaker Change: As you worked on some of the longer.
Speaker Change: <unk> treated.
Speaker Change: <unk> treated patients.
Speaker Change: As you saw in <unk>.
Speaker Change: With the $2 78 per patient.
Speaker Change: Patient on the tumor.
Speaker Change: There were over 30 weeks of treatment there was some dose reductions there and again patients are doing quite well. So they are very comfortable.
Speaker Change: And with the experiences and using other Chemotherapies for example, I'm doing dose modification.
Speaker Change: We have seen that this is.
Speaker Change: Has not led to any mitigation or reduction in the responses in so far as of this interim data.
Speaker Change: Got it that's helpful and maybe a last one any thoughts on why there is no correlation between efficacy and <unk> three expression.
Speaker Change: Yeah that was something we pointed out on the phase one study, we did not see see that either.
Speaker Change: We were observing responses even in patients that had lower H scores although this.
Speaker Change: This may be a situation that is a threshold.
Speaker Change: Effect, where U S. You have a modest number of of expression of <unk> seven or eight street, that's sufficient to provide entry of the.
Speaker Change: Toxic.
Speaker Change: Linker toxin.
Speaker Change: Into the cells. So we see that as it actually is a positive result.
Speaker Change: Our results here.
Speaker Change: Caveat is as of course these are archival specimens.
Speaker Change: And you.
Speaker Change: There may be some differences that you do fresh biopsies.
Speaker Change: Okay helpful. Thanks for taking my question.
Speaker Change: <unk>.
Speaker Change: Our next question comes from the line of Stephen Willey with Stifel.
Stephen Douglas Willey: Yes, good afternoon, thanks for taking the questions.
Stephen Douglas Willey: Just with respect to the pneumonitis I know that this is typically something that needs to be proactively looked for whether it's at the chest X ray or a C T and just.
Stephen Douglas Willey: I'm curious if if if if that was kind of a routine screening procedure for some of these patients and could some of the higher rates of Disney are that are observed in the 2.7 arm, including some of the grade three plus events.
Stephen Douglas Willey: Those would be I guess, maybe miss categorized as <unk>.
Stephen Douglas Willey: As pneumonitis in the context of perhaps not proactively screening for it.
Speaker Change: I don't believe that there is a screening protocols for this because as I pointed out earlier there was no.
Stephen Douglas Willey: Observed increase rate of pneumonitis.
Stephen Douglas Willey: In the population.
Stephen Douglas Willey: With regard to a patient that has Disney they would normally get as part of their.
Stephen Douglas Willey: Treatment, although I can't comment on the specific patients here is obviously.
Stephen Douglas Willey: For full workup.
Stephen Douglas Willey: Clearly there are a lot of different causes of Disney although again, the percentages are quite low so again I'll just reiterate the key.
Stephen Douglas Willey: Cases of pneumonitis are under investigation.
Stephen Douglas Willey: And.
Stephen Douglas Willey: Clearly there are.
Stephen Douglas Willey: At least the data to date other complicating factors.
Stephen Douglas Willey: One of the patients with pneumonitis of other medical issues.
Stephen Douglas Willey: And we still need to get.
Stephen Douglas Willey: Additional information on the on the other patients so.
Stephen Douglas Willey: It's still too early to.
Stephen Douglas Willey: Draw any conclusions.
Stephen Douglas Willey: Okay.
Speaker Change: And I'm not sure if it's in the presentation, but can you also.
Speaker Change:
Speaker Change: Provide us with what the median duration of follow up is in both of these both of these arms at this point.
Stephen Douglas Willey: It was it was it was.
Stephen Douglas Willey: There was.
Speaker Change: The time the time right. We don't have included here and I don't know off the top of my head but.
Speaker Change: What we do is obviously you saw on the swimmers plot.
Speaker Change: Oh.
Speaker Change: A large number of these are significant when these patients have exceeded the 16 to 20 weeks.
Speaker Change: Time interval there the number of doses median number mean number of doses is now five so.
Speaker Change: Which is on the <unk>.
Speaker Change: Basis.
Speaker Change: And then just lastly, I know this.
Speaker Change: This trial allowed for patients who had not been on I guess quote unquote stable.
Speaker Change:
Speaker Change: RPI.
Speaker Change: Months do.
Speaker Change: Do you know how the those ports are those patients attribute out between the two.
Speaker Change: Two treatment arms with respect to patient baselines.
Speaker Change: With regard.
Speaker Change: To that population.
Speaker Change: Without.
Speaker Change: I don't have the specific percentages in front of me.
Speaker Change: But as I recall I believe.
Speaker Change: It was about a 40% to 60% split in terms of less than 12 months greater than 12 months of historical era.
Speaker Change: Exposure.
Speaker Change: In that regard.
Speaker Change: Thanks for taking the questions.
Speaker Change: Yeah.
Speaker Change: Our next question comes from the line of Jon Miller with Evercore.
Jonathan Miller: Hi, guys. Thanks for taking my questions very interesting update here.
Jonathan Miller: Scott I would love to get a little bit more confirmation I know you said in response to an earlier question that you saw interruptions in discontinuation is looking better than phase one but that.
Jonathan Miller: Yes.
Jonathan Miller: Wanted to confirm that you said that and what exactly number you're pulling from when I look at the phase one poster I see 15% discontinuation is 59% interruptions that looks right in line with what we're seeing with today's update it at 15% and 56% of the two points at seven Mig per kg arm, there and for hand FTSE.
Jonathan Miller: Jerome while obviously the grading appears to be lower than this update you're seeing 31% in the phase one result, going to 23% of the $2 seven Meg arm.
Jonathan Miller: Day.
Jonathan Miller: So.
Jonathan Miller: When you look at the Tox signals versus phase one.
Jonathan Miller: You would characterize them as being much better than they were but I would love to see like is there a place of this particular number you can point you to say look this is where it got better. This is where docs are going to be comfortable dosing. This.
Jonathan Miller: This is the this is the linchpin number that is going to let people stay on therapy longer than they did in phase one.
Speaker Change: Yeah. So.
Jonathan Miller: Again, I want to do a compare apples to apples here and so I'm comparing.
Speaker Change: As we did in the <unk>.
Jonathan Miller: Previous.
Jonathan Miller: Safety data reveal.
Jonathan Miller: From the abstract.
Jonathan Miller: The comparison to the prostate cohort I believe.
Jonathan Miller: What you were pulling out is.
Jonathan Miller: All different different population, so I'm just looking.
Jonathan Miller: And I have and I and I know the specific data and.
Jonathan Miller: What I said before is absolutely correct.
Jonathan Miller: That.
Jonathan Miller: In the patients in the phase one study what do you look at severity of grade three whether you look at drug discontinuation.
Jonathan Miller: You look at.
Jonathan Miller: <unk> dose reductions, whether you look at drug interruptions the percentage of those patients in the phase one study was anywhere from greater than two times, what we're seeing at the same six at same time interval around 16 weeks I'm trying to as best.
Jonathan Miller: To do an apples to apples comparison from.
Jonathan Miller: A time exposure to drug now there could be some.
Jonathan Miller: Modest variations of what the ultimate drug exposure was.
Jonathan Miller: I am clearly seeing at least two to three times more of the side effect profiles and severity of grades in the phase one prostate arm versus what we're seeing here in tamarac and so again.
Speaker Change: I'll reiterate that.
Jonathan Miller: The feedback we're getting from the.
Jonathan Miller: Investigators has been.
Jonathan Miller: Manageable tolerability not concerning.
Jonathan Miller: And in addition.
Jonathan Miller: As I pointed out earlier the.
Jonathan Miller: We are now past, the where the mean number of doses and as Tamarac is these are the.
Jonathan Miller: Where we were in the phase one study and so you know I'm.
Jonathan Miller: I'm feeling very.
Jonathan Miller: Courage and that we're on the right pathway here for delivering this drug and as I showed.
Jonathan Miller: In the <unk>.
Jonathan Miller: Areas.
Jonathan Miller: Swimmers plots.
Jonathan Miller: The majority of the patients are still on an on treatment. Despite you know.
Jonathan Miller: Some of the dose modifications and interruption.
Speaker Change: Alright, Alright, I guess I understand that can maybe on the advocacy side.
Jonathan Miller: I would love to I don't see in the deck.
Jonathan Miller: How many prior lines of therapy, what's the median prior lines of therapy in this in these cohorts and then what are you looking at for the comps for <unk> in D. C are you in that population.
Jonathan Miller: So.
Jonathan Miller: Here as I as I.
Jonathan Miller: Pointed out.
Jonathan Miller: Entry criteria was no more than three lines of therapy, I don't know where it ended up.
Jonathan Miller: On.
Jonathan Miller: With regard to the medians for this study whether it was two or three but.
Speaker Change: We'll have to get back to you on that.
Speaker Change: Again in terms of the O R R.
Jonathan Miller: I mean if.
Jonathan Miller: If you if you listened.
Jonathan Miller: As you have to.
Jonathan Miller: So some of that continuous.
Jonathan Miller: Guidance, I had which I started back in November.
Jonathan Miller: We were seeing approximately.
Jonathan Miller: 25% confirmed unconfirmed.
Jonathan Miller: Great.
Jonathan Miller: Objective responses and what.
Jonathan Miller: Was observed in the Daiichi 7300, and their asthma presentation was a solid 25% as well the point I made was that.
Jonathan Miller: It's certainly achieved that 25%.
Jonathan Miller: By the end of the study and as we see here not only are we achieving it is likely we're going to exceed this.
Jonathan Miller: One is the final data comes out given that as.
Jonathan Miller: As I pointed out many of these patients are still on study, but we have a confirmed and unconfirmed or are in the in the $2 seven Nick.
Jonathan Miller: Kid of 43, 8% and in the two point, though Q4 in a confirmed confirmed a 24, 4%. So I you know I think we're doing quite well with.
Jonathan Miller: With regard to what the expectations were and what the data is as of this cut but again continue to expect further maturation of this data and continuing improvement.
Jonathan Miller: Alright.
Speaker Change: Makes sense.
Speaker Change: Can you talk about.
Speaker Change: Potential use of overdo it in combinations given the safety profile here.
Speaker Change: Not an innocuous.
Speaker Change: <unk> and some of the taxes are overlapping with other agents that you might expect to see in prostate.
Speaker Change: So I've been thinking about pneumonitis and perfusion for instance, so.
Speaker Change: Are you look at you know what what does this mean for potential use in combination and thereby uses in earlier lines of therapy.
Speaker Change: Compared to other.
Speaker Change: Programs that are enthusiastically pursuing larger combinations in early line therapy, well again.
Speaker Change: You know are very much interested in looking at.
Speaker Change: Combinations.
Speaker Change: Overdue all with different agents and as you know we have.
Speaker Change:
Speaker Change: Initiated.
Speaker Change: Dose finding studies.
Speaker Change: With a large German that PD, one <unk> four a dart bispecific molecule.
Speaker Change: And as.
Speaker Change: As I commented earlier.
Speaker Change: We expect to be able to define the go forward doses.
Speaker Change: From these dose dose finding studies very shortly where we not only look at.
Speaker Change: This combination in prostate cancer, but in other tumors as well and given that Mechanistically. We believe these are very orthogonal mechanisms for controlling tumor and as we've already shown in <unk>.
Speaker Change: <unk> is a bulker duo data that we described today Act.
Speaker Change: Activity.
Speaker Change: Independently.
Speaker Change: Single agent of Lora Gerald lab in late stage patients I think this will be a.
Speaker Change: Very good combinations to explore and we're looking at the potential of others as well.
Speaker Change: Alright, thanks very much.
Speaker Change: Okay.
etc Route: Our next question comes from the line of etc Route with BMO capital markets.
etc Route: Great. Thanks, I wanted to know if you could provide a little bit more color around sort of the combination with specifically with lower drilling that given that you had sort of indicated that you could move into sort of dose expansion studies with with Cobra and lower drilling in.
etc Route: In the first half I believe and maybe you could comment on where you are with that program and is that still sort of a viable plan moving forward given given the profile that we've seen today.
etc Route: Yeah.
etc Route: Our on track for moving forward with that I think we're at the final evaluation.
etc Route: The dose finding cohort of finding them.
Speaker Change: What the <unk>.
Speaker Change: Deal doses of each one when put together to maximize both the safety and activity.
Speaker Change: To explore so I think we will be in pretty good shape, but in the second half of the year to initiate.
Speaker Change: Enrollment in the prostate and potentially.
Speaker Change: Another tumor indications so stay tuned for that.
Speaker Change: Thank you.
Speaker Change: Our next question comes from my uncle months', Tommy which B Riley Securities.
Tommy: Good afternoon. Thanks for taking my question. So maybe on the look forward basis. If you could comment on your expectation for the ERP of first data.
Tommy: And how you may look to present that in the next few months based on what Youre seeing on durability median cycle, then and I think importantly, how you see based on all of that you know you see the split in the.
Tommy: And relative to PSM of SD Wan.
Tommy: When you think about sequencing you think about designing your phase III next year.
Speaker Change: Yeah. Thanks, Thanks very much.
Speaker Change: Right now.
Speaker Change: Again laid out the parameters here as baseline what we had indicated was in our PFS of at.
Speaker Change: Baseline of six but greater than obviously looking for 789 10 or higher I think that the data.
Speaker Change: That we showed today and the fact that these patients are still on therapy.
Speaker Change: I think we will ultimately see the results, but there is no reason.
Speaker Change: We can.
Speaker Change: Some of the longer list, our PSS values here. So we'll have to wait to the seen the results the.
Speaker Change: The expectation is that this would be.
Speaker Change: Presented at a scientific conference in the second half of this year.
Speaker Change: Yeah.
Speaker Change: Got it thank you and maybe just one quick clarification there.
Speaker Change: Too many RMB unpleasant.
Speaker Change: Patients in this study is that clients can do any kind of analysis.
Speaker Change: I'm, sorry did you say radiotherapy yeah R&D.
Speaker Change: Uh huh.
Speaker Change: That is true and as you saw on the <unk>.
Speaker Change: Geographic distribution of the patients there were a very modest.
Speaker Change: A modest number of patients from the U S where.
Speaker Change: They would have the ability to when we initiated the study and when the enrollment occurred to either have seen predict or have progressed on that.
Speaker Change: Given the.
Speaker Change: Timing of the marketing of that drug in the U S versus Europe, where the majority of the patients came from Western Europe. So.
Speaker Change: We expect a small numbers of those patients.
Speaker Change: In this study.
Speaker Change: Got it thanks for taking my questions.
Speaker Change: Our next question comes from the line of Silvan <unk> with citizens JMP Securities.
Silvan: Yeah, good afternoon, and thanks for taking my question.
Silvan: That's all right.
Silvan: When you find out about the adjudication of the gasoline.
Silvan: And a related or not would that be available by the time, we get that presentation at a medical conference in the second half.
Silvan: I would presume so obviously, we're giving you ongoing results.
Silvan: They all come in I mean, we're here.
Silvan: In early May and as we just did this data cut.
Silvan: In April so the.
Speaker Change: Patient is the teams are working very hard in.
Speaker Change: Finding out.
Speaker Change: The details on the patient studying and evaluating.
Speaker Change: Comorbidities and other things that may have contributed to the specific deaths.
Speaker Change: Alright, Okay somebody is looking at beef strike presumably between.
Speaker Change: Absolutely.
Speaker Change: Absolutely.
Speaker Change: Great.
Speaker Change: And then.
Speaker Change: Maybe talk to me, maybe if you can walk me either through the waterfall plot or basically I'm trying to understand or reconcile the.
Speaker Change: The unconfirmed responses, but there's a fair amount of MB and they're especially high.
Speaker Change: And the high dose arm.
Speaker Change: Where you are.
Speaker Change: The confirmed response rate was 25%, but it could be with your uncle affirmative highest 43% although responses. The majority wider in a comfort that is still ongoing and patients and FX can get or.
Speaker Change: Could you please characterize that well, yes, I mean, that's very.
Speaker Change: I look at the.
Speaker Change: The plus thereof, the swimmers plot save for the 2.7.
Speaker Change: <unk>.
Speaker Change: Timeframe, the timing frequency with regard.
Speaker Change: To the.
Speaker Change: Scans is every eight weeks and so again, if you look at the.
Speaker Change: The majority of these patients if they were still on therapy as of 16 weeks would have had two scans are those that had.
Speaker Change: Achieved 24 weeks would have had three scans and there's at least one patient that probably had four scans. So for instance, if you look at the patients with $2 seven mixed for Q4, the the the one on the top of the of that curve.
Speaker Change: They had the initial evaluation for PR that.
Speaker Change: Yeah.
Speaker Change: Cheese at.
Speaker Change: Eight week, the first scan, but it wasn't until the probably the fourth scan that it was confirmed.
Speaker Change: As a confirmed PR.
Speaker Change: No.
Speaker Change: The bottom line is is that it will take.
Speaker Change: Your time I mean, there are a number of patients I see here that have.
Speaker Change: One positive value and have not gotten the second scan yet to confirm it.
Speaker Change: Great. Thanks for taking my questions.
Speaker Change: Our next question comes from the line of Kelsey Goodwin with Guggenheim Partners.
Speaker Change: Yeah.
Kelsey Beatrice Goodwin: Oh, Hey, Thanks for taking my question I guess, given the early looks at durability with a swimmer plot.
Kelsey Beatrice Goodwin: For further resist evaluable patients at least I guess do you have any update on how youre thinking about them.
Kelsey Beatrice Goodwin: Where durability may land for the follow up there just any additional color you could provide there. Thank you.
Speaker Change: Yeah, I think it's just too early to say given that.
Speaker Change: Again, the majority of the patients are still on for example, the $2 seven mix per gig.
Speaker Change: In the patients with measurable disease, we have as noted here on the slide 62, 5%.
Speaker Change: That is still ongoing treatment so.
Kelsey Beatrice Goodwin: Again, we feel very encouraged that.
Kelsey Beatrice Goodwin: Given even at this point.
Kelsey Beatrice Goodwin: That.
Kelsey Beatrice Goodwin: We should be able to have.
Kelsey Beatrice Goodwin: A opportunity to treat a large number of these patients with NCR P C.
Speaker Change: Got it thank you and for the non res system locations I guess does the swimmer plot kind of are they representative for the non recessed evaluable patients as well as this.
Speaker Change: Got it yeah again, what we wanted to do is give you our representatives of seal for the various durability and we felt that this was a good representation with regard to.
Speaker Change: Resist a valuable.
Kelsey Beatrice Goodwin: With measurable disease at baseline, but I would say that they.
Kelsey Beatrice Goodwin: Our general view is that this can be extended to them.
Kelsey Beatrice Goodwin: You know patients with Bonnie diseases, well et cetera.
Speaker Change: So we're just.
Kelsey Beatrice Goodwin: We have this balance that we want to.
Kelsey Beatrice Goodwin: Provide investors a look at the data as we have promise, but at the same time is having.
Kelsey Beatrice Goodwin: Additional data that we can then.
Kelsey Beatrice Goodwin: <unk> debt at scientific conferences, but nothing here is.
Kelsey Beatrice Goodwin: More selective in that regard.
Speaker Change: Got it okay. Thank you so much.
Speaker Change: Our next question comes from the line of Peter Lawson with Barclays.
Peter Richard Lawson: Okay. Thank you. Thanks, Scott for the update just wondering if you could possibly characterize the spider plots looked like.
Peter Richard Lawson: Especially in sustaining all of the PSA Christie reduction Psa reductions.
Peter Richard Lawson: Moving over time.
Peter Richard Lawson: The best way, you can potentially characterize that.
Speaker Change: Again, what we're trying to do is give you a capsule southern but I would say that the spider plots.
Speaker Change: Exceptionally encouraging.
Speaker Change: As we have shown in the phase one data you will see initial reductions in TSA as an and.
Speaker Change: They seem to be sustained for long periods of time in time interval at least at this interim data going forward clearly there are individual patients that.
Speaker Change:
Speaker Change: We will not have the continued.
Speaker Change: PSA 50 responses, but I would say as are we.
Speaker Change: Characterize that phase one they do very well.
Speaker Change: Similarly.
Speaker Change: Over a long period of time.
Speaker Change: Okay. Thank you.
Speaker Change: The.
Speaker Change: PSA 50 reduction was hiring lower doses was that driven by.
Speaker Change: Although discontinuation rate or is there something else going on.
Speaker Change: I think this is just.
Speaker Change: Idiosyncratic I would not over interpret these.
Speaker Change: Even though these are.
Speaker Change: Nice size populations.
Speaker Change: I don't think there is anything particular, I would say I would more look at the.
Speaker Change: <unk>.
Speaker Change: I mean, the 50 50 with regard to the.
Speaker Change: <unk> that have that had at least one TSA 50 reduction.
Speaker Change: I think says that both populations are seeing a similar even though the.
Speaker Change: The confirmed ones seem a little low on the two seven I think it's.
Speaker Change: Spurious in that regard and then as I pointed out.
Speaker Change: Is expecting that those numbers could potentially increase over time, so I don't look at that as a.
Speaker Change: The sooner the parameter of a difference at this point.
Speaker Change: Okay. Thank you and then part of the question, whether the PSA reductions or if at all are or disease control rate currently.
Speaker Change: <unk> in your mind to this agent.
Speaker Change: PFS.
Speaker Change: My my sense, it's going to be our PFS and disease control rate as I pointed.
Speaker Change: Pointed out previously.
Speaker Change:
Speaker Change: Avoiding new growth of lesions is the is the most important thing here.
Speaker Change: And so that obviously is a patient is 30 or greater percentage with card is it.
Speaker Change: But if a patient is 20% reduction will be recorded as a stable disease.
Speaker Change: As long as there are no new lesions I think that that is fine.
Speaker Change: But again, we'll have to see.
Speaker Change: As the data continues to mature.
Speaker Change: Okay. Thank you so much.
Speaker Change: Yeah.
Speaker Change: Okay.
Dr. <unk>: That concludes today's question and answer session I'd like to turn the call back to Dr. <unk> for closing remarks.
Dr. <unk>: Thank you everybody for your questions today, and we look forward to following up the completion of the Tamarac study and further updates on our other programs.
Speaker Change: Soon have a good evening.
Speaker Change: Yeah.
Speaker Change: This concludes today's conference call.
Speaker Change: You for participating you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].