Q3 2024 MacroGenics Inc Earnings Call
Good afternoon. We will begin the Mechanics 2024-3rd Quarter Co-Ford Parker and Financial Results Conference Call and just a moment. Offer dispensers on a listen-only melody at the moment, and we will conduct a question and answer session at the conclusion of the call.
At the point I will turn the call over to Jim Carrels, Senior Vice President, Chief in the show.
Jim Carrels: Thank you, operator. Good afternoon and welcome to my Virginia Congress call to discuss our third quarter 2020-24 financial and operational results.
Jim Carrels: For anyone who is not at the chance to review these results, we should approach the latest afternoon outlining today's announcements. This release is available on the investors tab and website at macrogenex.com. You may also listen to this conference call via webcast on a website where it will be archived for 30 days beginning or possibly two hours after it calls completed.
Jim Carrels: I would like to alert listeners that today's discussion will include statements about the company's future expectations, plans, and prospects that constitute forelooking statements for purposes of the Safe Harbor Provision under the Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by these four 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.
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.
Jim Carrels: 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.
Speaker Change: 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 this afternoon.
But before I do so, let me first turn the call back to Jim, who will review our financial results.
Jim: Thank you, Scott. This afternoon, Microgenics reported financial results for the quarter ended September 30, 2024, which highlight our financial position.
Jim: As described in a release this afternoon, MacroGen's total revenue was $110.7 million for the quarter ended September 30, 2024, compared to total revenue of $10.4 million for the quarter ended September 30, 2023.
Jim: The increase was primarily due to $100 million in milestones received from Insight in August related to Retta Phamomab.
Jim: Our research and development expenses were $40.5 million for the quarter ended September 30, 2024, compared to $30.1 million for the quarter ended September 30, 2023.
Jim: The increase was primarily due to increased research and development costs related to the company's pre-clinical ADC pipeline, VOBRA Duo, and the Tamarack clinical trial.
Jim: our Selling General.
Jim: Administrative expenses were $14.1 million for the quarter ended September 30, 2024 compared to $12.4 million for the quarter ended September 30, 2023. The increase was primarily due to increased stock-based compensation expense and professional fees.
Jim: Our net income was $56.3 million for the quarter ended September 30, 2024, compared to net income of $17.6 million for the quarter ended September 30, 2023.
Jim: Net income for the quarter ended September 30, 2024 included the aforementioned $100 million in milestones from Insight.
Jim: Net income for the quarter end of September 30, 2023, included a $50 million milestone payment from Sanofi related to the previously disclosed achievement of a primary endpoint in a Teasdale clinical study, which was recorded in other income.
Our cash, cash equivalents, and markable securities balance as of September 30, 2024 was $200.4 million compared to $229.8 million as of December 31, 2023.
The balance of September 30, 2024, did not include the $40 million upfront payment anticipated from the closing of the Mergenza transaction or the $8 million amendment fee we plan to pay our current commercialization partner.
Jim: Finally, in terms of our cash runway, consistent with our prior guidance, we anticipate that our cash, cash equivalents, and marketable securities balance of $200.4 million as of September 30, 2024, plus the $40 million upfront payment anticipated from Tresera related to the Margenza transaction, less an $8 million amendment fee we expect to pay our current commercialization partner.
Jim: In addition to projected and anticipated future payments from partners should provide a cash runway into 2026.
Jim: Our anticipated funding requirements reflect expected expenditures related to the ongoing Phase II Tamarack and Lorikeet studies, as well as our other ongoing clinical and preclinical studies. And now, I'll turn the call back to Scott.
Scott: Thank you, Jim. We continue to believe our proprietary pipeline of product candidates has great promise, and I will walk you through each of our key programs.
Scott: Boverimidimab duocarmosine or BoverDuo is our ADC designed to deliver a DNA alkylating duocarmosine cytotoxic payload to tumors expressing B7H3.
Scott: B7H3 is a member of the B7 family of molecules involved in immune regulation.
OBERDUO is designed to take advantage of this antigen's broad expression across multiple solid tumor types.
Scott: We continue to believe D7H3 has the attributes of an ideal cancer target.
Scott: The TAVRAC phase 2 study is being conducted in MCRPC patients who have previously received an androgen receptor access targeted agent and up to one prior taxane containing regimen but no other chemotherapy.
Jim: While study participants are no longer being dosed in the trial, participants continue to be monitored for adverse events, disease progression, and survival.
Jim: The study's primary endpoint is radiographic progression-free survival, or RPFS.
Jim: Given that only 65 PSF events or 35.9% had accrued as of the July 9th of 2024 data cutoff
Jim: The Interim Median RPFS Estimates presented at the ESMO Congress in September were immature.
And because these results were immature, we believe they are likely to change as additional events accrue.
Jim: We expect to have mature median RPFS in hand no later than early 2025.
Jim: Assessment of future development alternatives for Bobra Duo will be based on several factors.
Jim: including the final Tamarack safety and efficacy data in MCR-PC, a review of the competitive treatment landscape for MCR-PC.
Jim: Resource allocation across our clinical portfolio, as well as potential partnering opportunities for Vulva Duo.
Jim: Until we complete our assessment of the monotherapy development opportunity in MCR-PC, we have paused our other development efforts in alternative tumor types, as well as the phase 1-2 dose combination study of Oviduo plus loradrolumab.
Jim: Recall that we have two other clinical
Jim: The first, MGCO26, is an investigational ADC incorporating a novel tubal isomerase-1 inhibitor-based linker payload, CINTEQ-ANE, which we licensed from Cinefix.
Jim: Our second additional B7H3-directed molecule is inoglutuzumab, an investigational FC-optimized monoclonal antibody.
Jim: MGC 026 incorporates a linker payload based on ExaTcan, a clinically validated and potent Camtothecan that readily combines with Cinefix's HydroSpace technology.
Jim: We initiated a phase 1 dose escalation study of MgCO26 early this year in patients with advanced solid tumors.
Jim: The variable domain of the molecule targeting B7H3 for MgCO26 is the same sequence contained in VOBERDUO.
Jim: We view the MGCO-26 as a complementary approach to VOBER DUO for targeting B7H3.
Jim: More specifically, we believe that having distinct mechanisms of action and potentially different safety and efficacy profiles, VOBERDUO and MGC 026 may address different cancers
Jim: tumor stages or be used in combination with alternate agents or potentially with one another to enhance their clinical utility.
Jim: We remain confident in the potential of targeting the B7A3 pathway regardless of the mechanism of action or payload.
Jim: Regarding Inovituzumab, our academic collaborators are enrolling the HEAT study and the investigators sponsored randomized phase two study of this molecule in up to 219 men with prostate cancer.
Jim: Next, I'll update you on laurogerlimab, our bi-specific tetravalent PD-1 by CTLA-4 DART molecule.
Jim: We designed loridrolumab to have preferential blockade on dual PD-1 CTLA-4-expressing cells, such as tumor-infiltrating lymphocytes, or TILs, which are most abundant in the tumor microenvironment.
Jim: We are enrolling the Laura Keats study, a randomized phase 2 clinical trial of loroduralumab in combination with docetaxel versus docetaxel alone in second-line chemotherapy naive MCR-PC patients.
Jim: The current study design includes the primary study endpoint of RPFS.
Jim: A total of 150 patients are planned to be treated in a 2-to-1 randomized study with more than 100 study participants enrolled to date.
Jim: We anticipate completing enrollment of the study late this year or early 2025 and providing a clinical data update on the study in the first half of 2025.
Jim: MgDL24 is our next generation bispecific CD123 by CD3DAR molecule that incorporates a CD3 component designed to minimize cytokine release syndrome while maintaining anti-tumor cytolytic activity
Jim: and permitting intermittent dosing through a longer half-life.
Jim: Our phase 1 dose escalation study of MGD-024 is ongoing in patients with TD-123 positive relapsed or refractory hematologic malignancies including acute myeloid leukemia and myelodysplastic syndromes.
Jim: Recall that Gilead has the option to
Jim: MGCO28 is our second topoisomerase-1 inhibitor-based ADC incorporating Cinefix's novel linker payload and an ADAM9 targeting antibody.
Jim: Adam-9 is a member of the Adam family of multifunctional type 1 transmembrane proteins that play a role in tumor genesis and cancer progression and is overexpressed in multiple cancers, making it an attractive target for cancer treatment.
Jim: We recently submitted an investigational new drug application for MGC 028 to the US FDA.
Jim: Beyond MGCO28, we are exploring additional molecules for potential future IND submission.
Jim: I look forward to telling you more about these additional molecules on future calls.
Jim: Finally, after quarter-end, we sold global rights to Marjituximab, which is marketed as Margenza, to Tessera Therapeutics LLC, a privately held biopharmaceutical company pursuant to an agreement announced a few weeks ago.
Jim: Tercera is expected to pay us 40 million dollars at closing and we may receive additional sales milestone payments of up to an aggregate of 35 million dollars.
Jim: The transaction is expected to close in the fourth quarter of 2024, subject to customary closing conditions.
Jim: We expect to pay an $8 million amendment fee to our current commercialization partner during the fourth quarter of 2024, and we'll manufacture Margenza drug substance on behalf of Tucera going forward.
Jim: The pending Marja Taksimev transaction, as well as the recently received $100 million in milestones from Insight, further strengthen our financial position.
Jim: enabling us to sharpen our focus on our key priorities of advancing our clinical stage assets while researching and developing the next wave of early stage product candidates.
Jim: Thank you all for joining today.
Jim: As you know, we announced last week that I will be stepping down as President and CEO early next year.
Jim: after nearly 25 years with macrogenics.
Jim: It's truly a milestone for me personally and professionally.
Jim: Together we've transformed ideas into biotech companies dedicated to helping patients.
Jim: I'm immensely proud of what we've achieved, particularly the advancement of therapeutics like Margenza, Zinus, and Tzild to FDA approval and our robust pipeline of antibody-based treatments.
Jim: This transition comes at a time when macrogenics is strongly positioned with a diverse and promising development portfolio and a solid financial foundation.
Jim: The board has initiated a thoughtful search for my successor, and I am committed to supporting the company during this period to ensure a seamless transition.
Jim: Looking ahead, I am confident in macrogenics' future.
Jim: Our near-term goals remain unchanged.
Jim: advancing our pipeline, expanding partnerships, and creating value for patients and shareholders alike.
Jim: I want to thank the Microgenics team, our board, our shareholders, and our partners for their dedication.
Jim: I look forward to continuing my support as an advisor and shareholder, and I'm excited to see all that macrogenics will accomplish in its next chapter.
Speaker Change: We would now be happy to open the call for questions. Operator?
Speaker Change: Thank you.
Speaker Change: Ladies and gentlemen, to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 1 1 again. Please stand by while we compile the Q&A roster.
Speaker Change: Now first question, coming from the line of Tara Bancroft with TD Koenig, your line is now open.
Speaker Change: Hey guys, this is Nick on for Tara. Thanks for taking our question. Just one for me, but I understand the parameters factoring into your decision will be multifold for this, but what do you need to specifically see from the data next year to make a decision about going forward or not for VoperDuo? And do you have any updated thoughts on a potential dose at this point? Thanks.
Speaker Change: Thank you very much, Nick. As you said, we are close to getting the final data. As we've noted, we've continued
Speaker Change: The observation of these patients post the last dosing, which occurred in July, the patients will be followed no longer than six more months.
Speaker Change: As I pointed out, there are a number of parameters to look at, obviously looking at the final RPFS.
Speaker Change: looking at the safety profile of the drug, looking at the competitive landscape, and assessing this in the context of other things we have in our portfolio. It's just too early at this point.
Speaker Change: to give the specific parameters which will determine next steps forward. So be patient and we should be able to provide some insights in the coming months.
Speaker Change: Thank you very much.
Speaker Change: Thank you.
Speaker Change: And our next question coming from the line of Jonathan Cheng with Lyric Partners, your line is now open.
Jonathan Cheng: Hi guys, thanks for taking my questions and of course best wishes to Scott.
Jonathan Cheng: First question on that point, can you provide any color around the search process for the next CEO and how we should be thinking about timelines for the transition?
Jonathan Cheng: And then second question on MGC-026, your second B7H3-ADC program, can you discuss how the phase one dose escalation is progressing and when could investors see initial clinical data from that program? Thank you.
Speaker Change: First, Jonathan, thank you very much. It's always been a pleasure working with you. In terms of the search process, as the announcement occurred last week,
Jonathan Cheng: There is a subgroup of the board that has been
Jonathan Cheng: selected to initiate the process. A search committee is going to be working with an outside firm.
Jonathan Cheng: and that process is just getting started.
Jonathan Cheng: The expectations, as I said, is that I will stay on. We're going to continue.
Speaker Change: with the strategy we have adopted and move the programs forward until the new CEO is selected.
Speaker Change: It's anticipated, obviously, these things...
Speaker Change: Take a few months. I will stay on until the new CEO is selected. So there should be a smooth handoff to anyone when that person comes on board.
Speaker Change: With regard to the O26 study, we're in the middle of dose escalation. The study is going quite well.
Jonathan Cheng: We're getting into our ranges right now where one might anticipate the beginning of responsiveness. The expectation here is that we would complete this study in 2025 and be able to report the data out in 2025.
Speaker Change: Understood. Thanks for taking the questions.
Jonathan Cheng: Thank you.
Speaker Change: Thank you.
Speaker Change: And our next question, coming from the line-up, Yigal Nkrumah-Pitts with City, your line is now open.
Speaker Change: Hi, this is Reena on Freegal. Thanks for taking my question. I just want to ask what kind of triggered the decision to halt the combo now versus earlier when the decision was taken to stop dosing patients in Tamarack and
Jonathan Cheng: If you could provide any more details on the color, on pausing the Lurigirl Lab Combo with Volcra, how many patients were dosed, were there any yeas reminiscent of what was seen in the Volcra Monotherapy, or just any additional color you might have there.
Speaker Change: Thank you very much for the question. As you know,
Speaker Change: We had proceeded with the combo study.
Jonathan Cheng: to the point where we were very comfortable with the doses that were achieved in the populations we were examining with the individual loroduralumab and Vobra in combination.
Jonathan Cheng: However, as we pointed out, is that we are looking at the final data for Tamarack coming up in the next couple of months.
Jonathan Cheng: We would look at the possibility of
Jonathan Cheng: exploring additional studies in in Vobra to fine-tune that if appropriate and therefore rather than continue moving forward in expansions
Jonathan Cheng: with the doses that we had already tested in combination. We wanted to get that final assessment of the appropriate VOBRA dose.
Jonathan Cheng: before we would then explore combinations going forward. So it's a judgment that we want to ultimately have the best dose going forward if we continue combination studies.
Speaker Change: Okay, that makes sense. Thanks for taking my question.
Speaker Change: Thank you. And our next question, coming
Speaker Change: I wonder, given now, you know, you've evaluated Vogt-Grode Duo preclinically and in the clinic,
Speaker Change: We've gotten a preclinical assessment of MGC 026. If you're seeing any, you know, notable differences in the profiles for those two ADCs from a safety perspective and how that profile could be differentiated from VOGRA on sort of safety, thank you.
Speaker Change: Thanks, Ed, sir. One would expect that, obviously, with Vover being a DNA alkylating agent and the O26...
Speaker Change: of being a TOPO1 inhibitor, one will see distinct safety profiles.
Jonathan Cheng: As I said, we want to get the final safety. We obviously achieved much with the Tamarack study with lowering the doses there.
Jonathan Cheng: But at this point, being only in the middle of dose escalation on O26, I can't give you a side-by-side comparison of the two. There will be distinct differences.
Jonathan Cheng: the differences in safety, but it's just too early to spell out the specifics at this point.
Speaker Change: Thank you.
Jonathan Cheng: Thank you.
Speaker Change: Our next question coming from the line of John Miller with Evercore ISI. Your line is now open.
John Miller: Hi guys, thanks for taking the question, and I'll echo my respect for Scott and, you know, as you've heard before, great to work with you for all these years.
Jonathan Cheng: I'd also love to ask about the Vobra-Lori combo that that you're pausing. How many patients have you dosed there? How much data do you have? And is there any chance we could see that data? Maybe around the same time that Lorikeet is coming out, or in the near term at any rate. And maybe from a Lori perspective, how do you view the landscape for Lori combinations going forward?
Jonathan Cheng: from here, whether it's with OBRADU or with other ADCs in prostate.
Speaker Change: Thanks so much, John. I really appreciate the personal comments. It's a pleasure to have been working with you and your colleagues as well.
Speaker Change: With regard to the number of patients, we did many
Speaker Change: and the actual specific numbers I can't answer to you off the top of my head.
Speaker Change: But in the double digits, in terms of looking at multiple doses, this was a 3 plus 3 assessment at various combinations.
Jonathan Cheng: But, of course, because we were enrolling patients with different tumor types.
Jonathan Cheng: the representation of any particular tumor type.
Jonathan Cheng: was quite small. So, at this point, we haven't assessed the form of presenting the data we have there. It is more likely that, as I said earlier, we want to assess the final results of Tamarack.
Jonathan Cheng: make some decisions whether we need further alterations of the VOBR dosing if we continue with the combination studies going forward.
Jonathan Cheng: With regard to the opportunity with Laura Gerlachmab, as you know, we are doing the Laura Keats study in combination with Dosie Taxel.
Jonathan Cheng: And as I noted earlier, that study will completely enroll by the end of the year or very early in 2025.
Jonathan Cheng: So we'll have data in 25 on that. And we are looking at opportunities.
Jonathan Cheng: of combining loroduralumab and other clinical settings, not only in prostate cancer with other agents, but it's again too early to assess that until we have the final data on the Laura Keats study.
Speaker Change: Let me just add to that just in case it wasn't completely clear to listeners. So the with regard to Vobra plus Lori, that combination, we've only studied that in dose escalation. We had thought we'd, you know, we would move into dose expansion later this year. Obviously we did not do that.
Speaker Change: So, all of our data comes from dose escalation and the dose expansion study was never actually commenced. Yeah, as Jim is pointing out again, it was a 3 plus 3 design in looking at that.
Speaker Change: Thank you.
Speaker Change: And our next question coming from the line of Kelsey Goodwin with Guggenheim Partners. Your line is now open.
Brittany: Hi, this is Brittany on for Health. Thank you.
Brittany: Thank you for taking our questions. I'd like to ask additionally about the lower key trial and the update that's coming in the first half of next year.
Jonathan Cheng: next year.
Speaker Change: in terms of the benchmark there and what would be considered okay.
Jonathan Cheng: Thanks very much with regard to the Lorikeet Study.
Speaker Change: You were a little soft on the...
Jonathan Cheng: sounds here.
Speaker Change: I just want to make sure everybody understood what the question was.
Jonathan Cheng: Clearly, we're looking here at a chemo-naive population. As you know, if you look at the standard of care of docetaxel alone,
Jonathan Cheng: If you look at the last three studies where docetaxel was tested, it's approximately 8 to 8.6.
Jonathan Cheng: months of RPFS.
Jonathan Cheng: benefit. Clearly, we would like to see a significant increase both in RPFS
Jonathan Cheng: and then ultimately, obviously, have a benefit seen in OS, the actual number. We are not in a position to declare at this point, but certainly would be in a, for our PSS.
Jonathan Cheng: will be certainly in a double-digit month of improvement.
Speaker Change: Thank you.
Speaker Change: And our next question coming from the line-up, Sylvain Drakon with Citizens JMP, your line is open.
Sylvain Drakon: Yeah, thank you. Thanks for taking my question and Scott.
Speaker Change: Thank you for working with us. It was great to work with you.
Sylvain Drakon: I have a question on MGD-024, you know, you've mentioned that Gilead has some opt-in at various points throughout this trial and this is ongoing and, you know, we may or may not get data next year.
Sylvain Drakon: Are any of those points next year? Could we find out next year? Thank you.
Speaker Change: Thank you very much again for your personal comments. With regard to the study, it's proceeding well. As you know, with active redirected T cell killing molecules,
Speaker Change: The FDA position is that one requires slow dose escalation, and we've been through many, many cohorts already, and we are continuing to dose escalate here. So I can't, at this point,
Sylvain Drakon: determine when the study will be completed. It is moving forward.
Sylvain Drakon: And nor can I...
Sylvain Drakon: with regard to opting in. They have the ability to wait until the end of the phase one data. So at this point, we have a very good collaboration. We share the data with them and we expect that the study will continue.
Speaker Change: Thank you.
Speaker Change: And our next question coming from the line of Mayank Mamtani with B Riley Securities. Your line is now open.
Mayank Mamtani: Good afternoon, Dean. Thanks for taking our questions and congrats to Scott for a long list of accomplishments that we missed. One big picture question, you know, you've tended to focus as an organization on prostate cancer.
Speaker Change: Could we see a bit of a strategy shift in terms of how we get to this?
Speaker Change: next chapter for glycogenics, and relatedly, if you're able to give us precise guidance, Scott, on when, and if at all, next year we could see both CRPC and maybe lung cancer-specific data for 026.
Speaker Change: to assess direct comparability to both your program and the peer B7S3 programs also getting to late-stage development. And then I have a follow-up.
Speaker Change: Yeah, thank you very much
Speaker Change: Again, for the personal comments as well.
Speaker Change: We embarked on
Speaker Change: of appropriate treatments, particularly for late-stage patients.
Speaker Change: There certainly was a need there, and that obviously led to the development of multiple molecules which we're pursuing, as you know, the B7H3 programs, as well as Laura Jarrell and that. And we will continue with that. And I've...
Speaker Change: discussed the results that we expect over the course of 2025.
Speaker Change: With regard to O26, as we've talked about with overdue or so with O26, we're looking at the use of this drug in a lot of different tumor types.
Speaker Change: The dose escalation is open to a wide range of B7H3-positive tumors.
Speaker Change: The plan going forward is to determine patients that have responses to O26.
Speaker Change: In the dose escalation, we have
Speaker Change: built into the Phase I study, the ability to do many expansions.
Speaker Change: And so, as a result,
Speaker Change: as well. But at this point, again, as I indicated, we're only in the middle of dose escalation and it's too early to determine.
Speaker Change: what specific tumor types we might pursue further.
Speaker Change: Great. And then one specific question regarding the TAMRAC learning. You know, the efficacy of VD, it seems, you know, generally comparable to post-vaccine. I was wondering if this could be because of...
Speaker Change: B7S3 expression pattern and its maintained expression pre and post chemo which could you know be different than say PSMA and is your expectation going forward that you know remains the case?
Speaker Change: as you intend to report the final Tamarack data.
Speaker Change: Yeah, so we are continuing to look at obviously both the chemo naive and the post-taxing settings
Speaker Change: for the Tamarack data.
Speaker Change: As we showed at ESMO and indicated, we're having, at the Landmark timeframe of six months, we're getting very good responses in both the chemo-naive
Speaker Change: as well as the chemo-experienced population. So at this point, until we have the final data, we haven't assessed...
Speaker Change: Thank you for having me. Thank you. Thank you.
Speaker Change: We pursue this further, again, as I pointed out earlier.
Speaker Change: There are a lot of things that we will assess.
Speaker Change: when we have the final data.
Speaker Change: But right now, it's still open to...
Speaker Change: chemo experience as well as the chemo naive population all comes down to the degree of activity the RPFS as well as the safety profile
Speaker Change: for Eye Treatment and Exposure, VSM Establishment.
Speaker Change: could compare relative to, you know, docetaxel trials that have been done in MCRPC previously, and could you just clarify if the OS results will also be available next year or would that take longer?
Speaker Change: With regard to the characteristics of the lorikeet I would say that the population for these chemo naive patients was quite similar to what was enrolled in the patients for Tamarack.
Speaker Change: So they obviously had progression on an antigen-receptive targeting agent.
Speaker Change: And so we think that this will be a population that is very characteristic of what
Speaker Change: is normally seen there for patients who, on the standard regimen, would get dulcetaxel.
Speaker Change: The fact that we have this as a controlled trial
Speaker Change: We will have our own data.
Speaker Change: to see what Dozie Taxel does alone.
Speaker Change: in the 50 patients or so that are treated with that agent alone as compared to historical data. So I'm feeling pretty confident that we will have a data set that is – will be – that
Speaker Change: nicely valuable as compared to historical studies.
Speaker Change: Now, with regard to overall survival, I think it will be too early to be able to report that out in 2025.
Speaker Change: But given that, as he said,
Speaker Change: The study will be complete and enrolled by the end of this year or very early in 2025.
Speaker Change: I think we'll be in very good shape to present, obviously, responses, PSA reductions, as well as RPFS in 25, but OS may be a little early.
Speaker Change: Thanks again for taking our questions.
Speaker Change: Thank you.
Speaker Change: Our next question coming from the line of Peter Lawson with Barclays, your line is now open.
Peter Lawson: Great, thank you so much. I guess as we think about your B7H3 acids...
Peter Lawson: I guess your second generation molecule, how far behind is that when we see the initial data? And kind of what do you want to see in that, I guess your first generation B7H3 to kind of...
Peter Lawson: that and how that moves forward.
Speaker Change: Thank you very much, Peter. You know, to comment, as you know, there are a number of other molecules...
Speaker Change: that are moving forward.
Speaker Change: For TOPO1 inhibitors, the data has been presented in a number of different scientific forums. Again, we see
Speaker Change: 026 was designed
Speaker Change: with regard to having a site-specific conjugation of the Cinefix ExaT-Can with the DAR-4.
Speaker Change: and with other profiles that, despite the fact that we may be behind in that particular molecule development as compared to others.
Speaker Change: The data that's been presented to date for competing molecules has been in a limited number of tumor types.
Speaker Change: And so, despite the fact...
Speaker Change: there has been data that has been shown particularly in
Speaker Change: small cell cancer, and in some cases,
Speaker Change: modest data in other lung cancers.
Speaker Change: We feel that we can be quite competitive with the O26 molecule once we finish dose escalation. And as I said earlier, we expect that data from the Phase I study to be available in 2025.
Speaker Change: With regard to the Vobra-Duo molecule, again, it's just too early to...
Speaker Change: spell out the opportunity here.
Speaker Change: as well as the final safety profile and whether further tweaking will be necessary for the dosing to move forward into a
Speaker Change: prostate indication. So stay tuned. We're still very encouraged by the prospects of both of our B7H3 ADC molecules.
Speaker Change: Thank you very much. And same here. I have the same feeling.
Speaker Change: Thank you. And as a reminder to ask a question please press star 1 1 and wait for your name to be announced. Our next question coming from the line of Stephen Willey with Stiefel. Your line is now open.
Stephen Willey: Yeah, good afternoon. Thanks for taking the questions. First I just wanted to say best of luck to you, Scott. I have certainly enjoyed all the interactions over the years.
Stephen Willey: Just curious as to whether or not the phase 1 dose escalation program is going to be pre-specifying for specific tumor types. If I remember correctly, I think Immunogen had outlined a...
Speaker Change: a few different tumor types that it was interested in as it ran that Phase I development program. I know that you were a partner with them, obviously.
Speaker Change: But just wondering if that list of tumor types has changed, just given that you've swapped the payload out, there's obviously an inherent sensitivity of different tumors to different payloads.
Speaker Change: would be curious if you could just give some information as to what tumors you're thinking about. Thanks.
Speaker Change: Yeah, thanks, Steve, and again, a real pleasure always working with you over the years.
Speaker Change: The answer is yes, we are going to limit the specific tumor types going forward. As you know, in particular, based on our own preclinical data as well as IHC data, we've shown overexpression in a number of tumor types.
Speaker Change: So one among the tumors that you could expect.
Speaker Change: and pancreatic cancer and at least another tumor type as well.
Speaker Change: We feel that that will give us the best sense as we dose-escalate to be able to see activity signals as well as obviously the safety profile of the drug. As you know, one of the challenges on the immunogen molecule is that we were never able to achieve.
Speaker Change: the targeted dose because of the eye toxicity that was observed.
Speaker Change: Thank you.
Speaker Change: And at this time, I see no further questions in the Q&A queue. I will now turn the call back over to Dr. Koenig for any closing remarks.
Dr. Koenig: Again, thank you everyone for your kind remarks personally and obviously we look forward to providing updates on our exciting programs and other company related activity on our next earnings call.
Speaker Change: and go out and vote if you haven't done it already.
Speaker Change: Good night, everyone.
Speaker Change: Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.
Speaker Change: Thank you.
Speaker Change: In the name of the Father, and of the Son, and of the Holy Ghost, and of the Holy Spirit. Amen.