Good afternoon. We will begin the MacroGenics 2023 Second Quarter Corporate Progress and Financial Results Conference Call in just a moment. All participants are in a 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 Karrels, Senior Vice President, Chief Financial Officer of MacroGenics.

Thank you, operator. Good afternoon and welcome to MacroGenics' conference call to discuss our second quarter 2023 financial and operational results. For anyone who's not had the chance to review these results, we issued a press release this afternoon outlining today's announcements, which is available under the Investors tab on our website at macrogenics.com. 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. I would like to alert listeners that today's 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 1995. 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. 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.

Thank you, Jim. I'd like to welcome everyone participating via conference call and webcast today. This afternoon, I will provide key updates on our clinical programs. But before I do so, let me first turn the call back to Jim, who will review our financial results.

Thank you, Scott. This afternoon, MacroGenics reported financial results for the quarter ended June 30, 2023, which highlight our financial position. As described in our release this afternoon, MacroGenics' total revenue was $13.1 million for the quarter ended June 30, 2023, compared to total revenue of $26 million for the quarter ended June 30, 2022. Revenue for the quarter ended June 30, 2023, included recognition of $1.6 million in contract manufacturing revenue and MARGENZA net sales of $5.1 million compared to net sales of $4.7 million for the quarter ended June 30, 2022. Our research and development expenses were $43.2 million for the quarter ended June 30, 2023, compared to $51.7 million for the quarter ended June 30, 2022. The decrease was primarily due to decreased costs related to discontinued studies, partially offset by increased expenses related to preclinical antibody drug conjugate or ADC molecules and increased clinical expenses related to lorigerlimab and Vobra Duo. Our selling, general, and administrative expenses were $13.7 million for each of the quarters ended June 30, 2023, and 2022. You'll notice approximately $100 million as a component of other income on our income statement. Let me take a moment to explain. Under GAAP guidelines and pursuant to FASB's ASC 470 in March 2023, we recorded the $100 million proceeds received from the sale of our royalty interest on global net sales of TZIELD to DRI Healthcare Acquisitions LP, or DRI, as a Liability related to future royalties. This liability was to be amortized over the term of the arrangement using the effective interest rate method. Sanofi subsequently acquired both Prevention Bio and the TZIELD royalty interest and milestone obligations from DRI on April 27, 2023, obviating the need for MacroGenics' involvement in the transfer of royalty payments to DRI. This resulted in a change to the arrangement, which was evaluated as a modification under the provisions of ASC 470. Accordingly, we recognized approximately $100 million as a component of other income on our financial statements for the quarter ended June 30, 2023. Our net income was $57.5 million for the quarter ended June 30, 2023, compared to a net loss of $41.3 million for the quarter ended June 30, 2022. Our cash, cash equivalents, and marketable securities balance as of June 30, 2023, was $240.3 million compared to $154.3 million as of December 31, 2022. Our cash balance as of June 30, 2023, did not include a $50 million milestone payment from Sanofi subsequently earned. Payment of this milestone was triggered pursuant to Sanofi's July 28 announcement that the PROTECT placebo-controlled study investigating TZIELD or teplizumab in patients with newly diagnosed Stage 3 type 1 diabetes met its primary endpoint, having demonstrated preservation of beta cell function. This milestone was part of the March 2023 agreement originally between MacroGenics and DRI. The royalty interest and milestone payment obligations of which were sold by DRI to a subsidiary of Sanofi in April 2023. And finally, in terms of our cash runway, we anticipate that our cash, cash equivalents, and marketable securities balance of $240.3 million. As of June 30, 2023, the $50 million milestone subsequently earned in addition to projected and anticipated future payments from partners and product revenues should extend our cash runway into 2026. Our anticipated funding requirements reflect expected expenditures related to the Phase 2 TAMARACK clinical trial, the Phase 2 study of lorigerlimab in metastatic castration-resistant prostate cancer, as well as our other clinical and preclinical studies currently ongoing. And now I'll turn the call back to 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 momentarily as well as tell you about our plans for upcoming clinical programs. But before I do that, I'll quickly remind you that over the past year, through our business development efforts as well as milestone achievement, we have generated $320 million of non-dilutive capital. Lorigerlimab, duocarmazine or Vobra Duo is our ADC designed to deliver DNA-alkylating duocarmazine cytotoxic payload to tumors expressing B7-H3. B7-H3 is a member of the B7 family of molecules involved in immune regulation. Vobra Duo was designed to take advantage of this antigen's broad expression across multiple solid tumor types. We began enrolling the TAMARACK Phase 2 study of Vobra Duo in patients with metastatic castration-resistant prostate cancer under a modified study protocol during the second quarter. You may recall that we made this modification to address the changing treatment landscape for patients with mCRPC, and enrollment has been proceeding nicely. We hope to enroll a majority of the 100 patients across the two experimental arms of 2 mg/kg or 2.7 mg/kg every four weeks in 2023 and provide a clinical update in 2024. Next, I'll update you on lorigerlimab, our bispecific tetravalent PD-1 x CTLA-4 DART molecule. We designed lorigerlimab 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. You may recall that we presented encouraging preliminary clinical results from a single-arm dose expansion study of lorigerlimab in patients with advanced solid tumors in a poster session at the ASCO Genitourinary Cancer Symposium in February 2023. Based on the strength of the mCRPC data presented, we plan to commence enrollment of a randomized Phase 2 study of lorigerlimab in combination with docetaxel versus docetaxel alone in second-line chemotherapy naive and mCRPC patients in the coming weeks. A total of 150 patients are planned to be treated in the 2:1 randomized study. The current study design includes the primary study endpoints of radiographic progression-free survival. In addition, we continue to enroll patients in the Phase 1 dose escalation study of Vobra Duo in combination with lorigerlimab in patients with advanced solid tumors, including renal cell carcinoma, pancreatic cancer, ovarian cancer, hepatocellular carcinoma, mCRPC, and melanoma. We anticipate commencing the dose expansion portion of the study by year-end 2023. Next up, MGD-024 is our next-generation bispecific CD123xCD3 DART molecule that incorporates the CD3 component designed to minimize cytokine release syndrome while maintaining anti-tumor cytolytic activity and permitting intermittent dosing through a longer half-life. Our Phase 1 dose escalation study of MGD-024 is ongoing in patients with CD123 positive relapsed or refractory hematologic malignancies, including acute myeloid leukemia and myelodysplastic syndromes. Recall that Gilead has the option to license MGD-024 at predefined decision points during the Phase 1 study. Finally, enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3. Based on the recently published results from a Phase 2 investigator-sponsored study of enoblituzumab in men with prostate cancer, MacroGenics and collaborators from multiple academic institutions plan to initiate an investigator-sponsored, randomized, translationally intensive neoadjuvant prostate cancer study in a high-risk population by early 2024. And now I'd like to give you some perspective on where MacroGenics intends to advance. I'll remind you that over our history, we have maintained our focus on developing innovative antibody-based therapeutics, having had a role in the development of three products now approved by the US FDA; MARGENZA, TZIELD, and ZYNYZ. More recently, as an extension of the synthesis, we've accelerated our ADC efforts. This has been possible through the following: First, our technology-enabling partnerships, most notably our two collaborations with Synaptics, which has recently been purchased by Lonza. We have reviewed multiple linker payload technologies and are pursuing Synaptics' approach, which utilizes various linker toxins conjugated to a site-specific glycan within the Fc-domain of antibodies. This affords us the ability to exploit different cytotoxic mechanisms, including topoisomerase inhibition, microtubule inhibition, and DNA damage in up to seven ADC molecules incorporating Synaptics' technology. The second element we believe allows us to extend our reach into ADCs is leveraging our 20-plus-year history of pursuing first-in-class target discovery in addition to our antibody engineering expertise. Finally, the third element is our proven ability to develop product candidates through FDA approval, coupled with our commercial-scale manufacturing and external supply chain management capability. We are very excited about where this could take us in developing ADCs to treat cancer. As previously indicated, we intend to submit an investigational new drug or IND application to the US FDA by the end of this year for the first of potentially multiple new ADC molecules, which incorporate a topoisomerase inhibitor payload. To conclude, we believe we have the technical development, clinical expertise, and even the necessary financial resources to support execution on our plan of developing and delivering life-changing medicines to cancer patients in 2023 and beyond. We would now be happy to open the call for questions.

Thank you. Our first question comes from Jonathan Chang with Leerink Partners. Your line is open.

Hi guys. Thanks for taking my questions. First question, can you give us a sense of how enrollment in the Phase 2 TAMARACK study has progressed? Just trying to get a sense of when in 2024 might we see data?

Thank you, Jonathan. I'm very encouraged by the speed of enrollment at this point now, as many of these sites have incorporated the amendments to the protocol. We still have additional site initiation visits to complete on additional sites, but based on what we've been seeing in this group of sites, I stick with what I have said that the majority of patients should be enrolled in the study this year, and we should complete it in the first part of 2024.

Got it. Thank you. And second question, what do you need to see from the Phase 2 prostate cancer studies to support advancing these programs into the next stage of development?

So, with regard to TAMARACK, as you know, we had seen very encouraging data regarding late-stage mCRPC patients with regard to PSA50 reductions as well as objective responses. The goal of this study, in fact, is to achieve responses in terms of efficacy that were similar to that observed at the doses that we had treated before, as you recall, 3 mg/kg on a Q3 weekly basis, but most of those patients had dose reductions during those courses. What is more important at this point is to see some improvement in the side effect profile. In particular, the most disconcerting side effect was hand-foot syndrome in these patients who developed Grade 2 with pain. So, we would like to see a reduction, obviously, in that grade and also the incidence as well. Regarding the efficacy parameters, again, just to refresh everybody's memory, we saw approximately half of those patients have PSA50 reductions, so of course, we would like to see in the range of around 40% to 60% or even better, obviously, if that is achievable in that population with concomitant tumor control and continued treatment. With regard to the lorigerlimab study in terms of outcomes, obviously, we are looking for an acceptable safety profile in terms of efficacy. If you look at the historical data in terms of control groups, which we obviously include here of patients treated with docetaxel, historical data shows RPFF of eight months is what you would like to exceed. So, we'll have to see if we're able to achieve that by certainly several months.

Got it. Thanks for taking the questions.

Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open.

Thanks. I guess initially, just as a follow-up to Jonathan's question. The data that we could see for your B7-H3 for the Phase 2 data, could we see that in the second half of 2024? And for the Phase 1 combination data, is that something like a first half 2024 data sets go?

So, Peter, as things go now, as I said to Jonathan, the encouragement about where we are enrolling if this continues at this pace, I think the second half and the presentation of data is certainly possible for the TAMARACK study. So, obviously, we'll have to monitor that for the rest of the year in terms of enrollment. I should point out that this is an open study. So, we will take interim looks at that data along the way and may be able to come to some conclusions earlier before we even have the full body of data from that study. So, again, I would be consistent with targeting the second half of the year at this point. With regard to the combination study, as we pointed out, we are trying to fine-tune the combination of Vobra with lorigerlimab right now individually in combination. Once we settle on what those doses to use moving forward in combination in expansion studies, we expect that to occur by the end of the year. So, again, could it be the first half of the year possible? But right now, let me bring you up to date once we have picked those doses and started those expansions; I'll be able to give you a little bit more definition as to when that will happen.

Got you. Thank you. And then there is an update this year. Kind of what kind of update will that be? Will we see data? Is it kind of a go-no-go decision? And will the data involve the lung cancer data?

So, as you know, and we discussed this before, ImmunoGen is conducting clinical studies. They are following through on the patients with lung cancer to identify an appropriate path as they are making decisions about moving forward. We have not discussed with them the specifics about what would be discussed and presented, and we should be doing that soon. So, again, updates later this year, the nature of what will be contained, I don't have an answer for you at this time.

Thank you. Our next question comes from Charles Zhu with Guggenheim. Your line is open.

Hi guys. This is Rosy on for Charles Zhu. Thanks for taking our question. So, first question is with regard to the change in landscape in mCRPC. How are you changing or selling expectations with regards to the valid positioning of Vobra Duo and lorigerlimab next to something like PLUVICTO?

So, if I understand your question, how are we anticipating the use of these drugs in face of where PLUVICTO is at this point and in the future. Is that correct?

Yes.

Okay. So, clearly, PLUVICTO has changed the treatment landscape. It is being used currently in major medical centers that have PET scanning capabilities for PSMA. There has been, as you know, some limitation in its distribution in terms of supply, which is being addressed by Novartis. So, there will be increased use over time. At this point, we have to wait to see the data on the results of PLUVICTO in earlier lines of therapy. So right now, it's more in a later line of therapy. When we have completed our study results, we will evaluate where the appropriate line of therapy will be and which populations. But right now, it's just too early. Mechanistically, we're talking about completely different mechanisms, and also the toxicity profiles are quite different. And so I think that this is an opportunity where different mechanisms of action give a greater number of choices for treating physicians and their patients. So, I think it's a good story for patients that new modalities will be available very soon.

Thank you. And if I can ask the second real quick on this one is regarding the Vobra Duo combo. Are there specific histologies that you potentially want to focus on for the dose expansion?

Well, as we pointed out in today's call and previously, we are looking at six different solid tumor types right now. We have not selected which ones to do yet for the expansion. Certainly, prostate cancer will be one of them, which additional others we will select, we have yet to make that decision. And we'll again, in the near-term, we'll be able to provide that information.

Thank you. Our next question comes from Etzer Darout with BMO Capital Markets. Your line is open.

Great. Thanks for taking the question. First one, just wondered if you plan to disclose any of the data from the dose escalation of Vobra Duo plus lorigerlimab prior to moving into expansion studies? And then secondly, if you could maybe comment on the progress of any of the other tumor types, Lori sort of monotherapy, maybe any progress there with other tumor types when we could get an update there or any other tumor types that you would look to explore with Lori or either monotherapy or combinations? Thank you.

Yes. So, Etzer, we'll have to again, as you know, as I've said just earlier today, we're honing in on the specific doses for the individual components of the Vobra Duo combo. Ultimately, it will be determined by how many patients we have available at that time to assess. My inclination right now is to start and move forward in expansions in particular types, which I alluded to before, prostate and probably one or two others. And probably at that time, once we have that data, we would be in a better position to present the total data. But again, this is subject to further discussions later this year. Regarding other tumor types of Lori besides the data we presented at ASCO GU, as you know, we have previously indicated that we've had objective responses in three other cohorts that we were testing, including microsatellite-stable colorectal cancer, melanoma, and lung cancer. What I've also indicated on previous calls is that for us to move forward into a more comprehensive Phase 2 study, I'd like to see some additional patients being treated as monotherapy to better determine the activity in particular tumors. I pointed out, for example, in the lung cancer cohort that we had, we lost a lot of that data because of patients that were treated in Ukraine for the case of the stable colorectal cancer patients. I pointed out we had very few patients without liver metastasis, which has been pursued by others, so I'd like to see additional patients being treated as monotherapy before making decisions going forward. The melanoma data, we're very encouraged by. As you know, historically, we've had noted that we've had very significant responses with Vobra Duo and melanoma as well. And that is one of the tumor types where we are potentially enrolling in the combination study going forward.

Great. Thank you.

Thank you. Our next question comes from Kaveri Pohlman with BTIG. Your line is open.

Yes, good evening. Thank you. Thanks for the update and for taking my questions. Sorry if I missed this, but for lorigerlimab and docetaxel combination study, it's a randomized trial for 150 patients. Can you give us a sense of how long it will take to enroll the study and to get RPFS? Also, do you think that you can expand it to a free trial if the interim data looks good? Just want to know how you're thinking about it?

Yes, Kaveri, thank you very much. So, we're very close to enrolling the first patients. We've initiated sites, and patients are being screened now. So, we're really on target for what we have said regarding the startup of this trial. Right now, until we start enrolling, you won't know the rate of enrollment. But the expectation is that it will take us through this year and into a good part of 2024. At this point, it would be too early to predict when we'd be able to do the readout of the study, most likely in early 2025, but that's all conjecture at this point.

Got it. That's very helpful. And then for MGD-024, can you tell us how the enrollment is going? Any feedback you have received from the physicians so far? And can you accelerate dosing based on your previous clinical experience with lorigerlimab here?

So, as you know, irrespective of what the product is, any CD3-based bispecific molecule when interacting with the regulatory agencies has a lot of prudence in terms of the dose escalation speeds in which these things can be conducted, despite the fact that we had very significant data showing dramatic reductions in cytokine production in primate model systems and anticipate that we could move this faster. But having said that, we are following what was discussed with the FDA. We are right in the middle of dose escalation. The study is going well, and that's all I can say at this point. My sense is that once the dose has been picked from that dose escalation and we go into a more Phase 2-like study, there may be greater opportunities to accelerate development. But again, that will be with either Gilead, if they opt into the program after the Phase 1, or during Phase 1, or by ourselves if it warrants it. So, it's still too early to tell.

Makes sense. Thank you.

Thank you. Our next question comes from Yigal Nochomovitz with Citigroup. Your line is open.

Hi Scott. Thanks for addressing the questions. Regarding the TAMARACK study in metastatic CRPC and the Phase 1/2 dose escalation with the combination therapy, I believe you mentioned CRPC as well and expressed interest in conducting an expansion. Could you clarify if the prostate patients in these studies have a similar level of pretreatment? You noted advanced solid tumors for CRPC, so it was not clear whether the patients in the Phase 1/2 study were more heavily pretreated compared to those in TAMARACK.

So, there are some slight differences in eligibility; we have a little bit wider criteria in TAMARACK, but the majority of the patients will be quite similar. We obviously wanted to compare apples-to-apples with the modification of those. We obviously wanted to get this enrolled quickly. So, there were some minor changes, but I would say they will be very easily comparable to the previous data. The same story applies to the combo for whatever prostate patients come in very late-stage patients as well, typically have advanced on androgen receptor targeting agents, on a taxane and often experimental agents as well. So, we think the data set will allow us to compare each one.

The reason I ask is because, I mean, if you do the prostate expansion in the Phase 1/2 with the Vobra and lorigerlimab, and that looks really good. I'm just curious how you're thinking about pivotal study and how you would register the product because whether you'd want to register with the monotherapy with Vobra Duo or if the lorigerlimab, Vobra Duo looks really good in prostate, if that would be the way to go forward to take the drug to market, that's more of a strategic question, but just curious how you're thinking about that?

Yes. So, obviously, this is a constant discussion. With the data on the lorigerlimab monotherapy being so encouraging, we decided to move a little bit up the line with now going into chemo-naive patients but with androgen receptor experienced patients. At this point, there is no other checkpoint that is vying for that population. So, this is a great opportunity when we can demonstrate success in that line of therapy. Regarding the Vobra story, whether as monotherapy or potentially in combination with Lori, that's a nice problem to have; both look very successful, both the results from TAMARACK and then the combo. We'll address that as the data comes out next year.

Thank you. Our next question comes from Stephen Willey with Stifel. Your line is open.

Yes, good afternoon. Thanks for taking the questions. I guess now that you've removed the control arm from TAMARACK? I'm guessing there's going to be more of an emphasis on response rate versus any kind of event-driven efficacy data. So, I guess I'm just curious based upon the eligibility criteria of TAMARACK? What percentage of patients you're expecting to actually have soft tissue disease that is RESIST valuable?

With that parameter, I think our experience in many of the trials to date have at least half those patients, and I would not be surprised given this is an international study based on the results from the Lori trial that we presented almost all of the majority of those patients had visceral involvement that was not limited only. So, I'm not at this point, I am not concerned that we will be seeing a tissue-limited population. I think there will be enough data to support that. And clearly, we'll monitor that going forward; we can add more patients if necessary, but I don't think that's going to be a problem.

Okay. And I guess just a question on Vobra Duo. So, you pressed the pause button here on single-agent dose expansion in other tumor types. I think that's despite some of the early signs of efficacy that you talked about earlier. Are you thinking of reinitiating any of those development efforts again once you get confirmation on dosing and scheduling from TAMARACK, or does this next-gen ADC effort now kind of get prioritized in front of Vobra Duo?

We are definitely interested in exploring additional tumor types due to the widespread expression of B7-H3 in various solid tumors and our previous experiences. We are looking for improvements in safety with Vobra Duo, as I mentioned earlier. While we could move forward now, I think it's wiser to wait since enrollment is progressing well, and we will soon be able to evaluate other types at that time. We are convinced that we are establishing a strong presence in the prostate cancer field with Lori and Vobra, which we see as a promising combination. Today, we discussed plans to begin a neoadjuvant study with enoblituzumab in collaboration with academic partners in prostate cancer. We aim to address the full spectrum of treatment options for prostate cancer patients, but this does not diminish our eagerness to pursue opportunities in other tumors as well.

All right. Thanks for taking the questions.

Thank you. Our next question comes from Jon Miller with Evercore ISI. Your line is open.

Hi guys. Thanks for taking the questions. I would like to ask more about the financials and the runway guidance. So, obviously, you mentioned that covers TAMARACK and Lori Phase 2 ongoing trial. How much does that cover of a new ADC? How much does that cover four trials that aren't currently running or anticipated to start? And does that count any new indications, either for Vobra Duo or for Lori in expansion?

Yes. Thanks, Jon. Very good question. Obviously, with today's announcement, we're very excited about getting that additional $50 million milestone from achieving it through the results of the PROTECT study. To put it in context, as we said earlier, with the $320 million in the past, you have non-dilutive capital; the likelihood of additional milestones goes up due to hitting the primary endpoint. Of course, it's dependent on the opportunity to get TZIELD approved in the new indication as well as different regions for the original indication that has already been approved in the US FDA. The increase in likelihood there means potential increased opportunities for more milestones as well as royalties. I should also point out that we announced last week that they completed enrollment in the two registration studies for the anti-PD-1 in lung cancer and anal cancer. So, getting back to the essence of your question, just with this additional 50 and the studies ongoing, that does include the new antibody drug conjugate that we will file an IND for in the fourth quarter this year. It does consider the opportunity to conduct additional studies, whether it be for new tumor indications or additional studies in different lines of prostate cancer. Those are currently under discussion right now. And it doesn't take away from any of the preclinical work for a second ADC from Synaptics that we have mentioned, which is ongoing right now and we're hoping to target for an IND in 2024, plus a lot of other preclinical development activities that we have not discussed to date. We are very encouraged with both our cash runway and the opportunity to pursue a very robust clinical and preclinical pipeline.

Great. That makes sense. I guess, I know you sometimes include risk-adjusted future milestones in your cash runway. Can you talk a little bit about how much of that potential $1 billion in milestones you're counting on when you give that runway into 2026?

Yes, we haven't broken that down. Clearly, we make those adjustments based on real-time results. And certainly, we have the opportunity to adjust a probability based on the fact that Sanofi has said that they are going for regulatory approval. Obviously, we'd like to see the data. We have not seen the data on the results of the new study. But we are not in a position to break out the specifics there.

This is Jim. I would just add that historically, if we look back at the probabilities that we use for risk adjustment, we've been very conservative.

Okay, makes sense. Thanks so much.

Thank you.

Thank you. Our next question comes from Silvan Tuerkcan with JMP Securities. Your line is open.

Yes, hi. Thanks for taking my question. A couple of questions on TAMARACK here. The patient group that you're expecting to enroll by the end of the year or maybe early next year, will that have sufficient chemo-naive patients that could be also an option that may be better than the chemo-experienced patients for a registrational study? Or what are your options after in terms of patient population that you have in the Phase 2 to go on?

No. Actually, one of the strict enrollment criteria is that patients must have been exposed to a chemotherapeutic, most likely docetaxel. In this particular study, we want to compare the results of our previous experiences with Vobra in a late-line population that has undergone chemotherapy. We are definitely interested in exploring opportunities in earlier lines of therapy, including hormone-sensitive populations, but nothing is currently being considered.

Great. Thanks. That's very helpful. And then at ASCO, we saw first in human data from the ADC directed B7-H3. Are there any learnings from that, that we can apply to Vobra Duo?

Yes, I mean, I would say the most encouraging data was obviously a small dataset, and they were highlighting expansion in other tumor types. Of the nine patients with small cell lung cancer, seven had objective responses, which fits the data that has been discussed in the small cell population. Clearly, this is a histological type that we are certainly considering adding to the types being tested. We have only had one patient with small cell cancer in our dose escalation, who actually did very well on Vobra at a lower dose that patient was on treatment for over six months with tumor shrinkage. I didn't have an objective response, but really responded well to the therapy. So, clearly, that opens up for us a confirmation that small cell may be an indication we should also pursue.

Great. Well, thanks for taking my question.

Thank you.

Thank you. Our next question comes from Boris Peaker with TD Cowen. Your line is open.

Hi. My name is Boris Peaker. I would like to ask how confident you are that the two doses being tested for Vobra Duo will provide clarity for moving forward. Regarding the registrational trial, do you anticipate that further dose modifications will be necessary?

In any experiment, you start with the data available and a hypothesis. We believe that the doses we chose were appropriate, based on a comprehensive analysis of the data and the various expansion groups concerning side effects, tumor responses, and pharmacokinetics. We aimed to align our selections with the actual patient exposure, noting that most patients experienced dose reductions. We believe we have identified the two doses that will provide greater insight into both safety and efficacy. We are hopeful that this selection proves to be correct. If we need to make any adjustments based on the data we collect, we will do so, provided the drug demonstrates both effectiveness and a reasonable safety profile.

Got it. Thank you for taking my question.

Thank you. There are no further questions. I'd like to turn the call back over to Dr. Koenig for closing remarks.

Well, thank you very much, operator, and thank you everyone for participating in our call today. We look forward to providing further updates both on our clinical and preclinical pipeline in the coming months. Have a good day.

Thank you for your participation. This does conclude the program and you may now disconnect. Everyone, enjoy the rest of your day.