adminMacroGenics, Inc. (NASDAQ:MGNX) Q3 2023 Earnings Conference Call November 6, 2023 4:30 PM ET
Company Participants
Scott Koenig – President and Chief Executive Officer
Jim Karrels – Senior Vice President and Chief Financial Officer
Conference Call Participants
Charles Zhu – Guggenheim Securities
Kaveri Pohlman – BTIG
Etzer Darout – BMO Capital Markets
Jon Miller – Evercore
Peter Lawson – Barclays
Silvan Tuerkcan – JMP Securities
Faisal Khurshid – Leerink Partners
Stephen Willey – Stifel
Operator
Good afternoon. We will begin the MacroGenics 2023 Third Quarter Corporate Progress and Financial Results Conference Call in just a moment. [Operator Instructions] At this point, I will turn the call over to Jim Karrels, Senior Vice President and Chief Financial Officer of MacroGenics.
Jim Karrels
Thank you, operator. Good afternoon and welcome to MacroGenics’ conference call to discuss our third quarter 2023 financial and operational results. For anyone who has 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.
We 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 CEO of MacroGenics.
Scott Koenig
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 result.
Jim Karrels
Thank you, Scott. This afternoon MacroGenics reported financial results for the quarter ended September 30, 2023 which highlight our financial position. As described in our release this afternoon, MacroGenics total revenue was $10.4 million for the quarter ended September 30, 2023 compared to total revenue of $41.7 million for the quarter ended September 30, 2022. The decrease reflects the recognition of $30 million in revenue under the Incyte license agreement during 3 months ended September 30, 2022.
Revenue for the quarter ended September 30, 2023 included recognition of $4.5 million in contract manufacturing revenue and MARGENZA net sales of $4.7 million compared to $4.4 million for the quarter ended September 30, 2022.
Our research and development expenses were $30.1 million for the quarter ended September 30, 2023 compared to $48.2 million for the quarter ended September 30, 2022. The decrease was primarily related to decreased costs related to discontinued studies, partially offset by increased expenses related to preclinical Antibody Drug Conjugates, or ADC molecules and increased clinical expenses related to lorigerlimab. Our selling, general and administrative expenses were $12.4 million for the quarter ended September 30, 2023 compared to $15.4 million for the quarter ended September 30, 2022. The decrease was primarily related to, decreased selling costs for MARGENZA.
During the quarter ended September 30, 2023 MacroGenics received a $50 million milestone payment from Sanofi related to the achievement of a primary endpoint in a TZIELD clinical study. The accounting treatment for this milestone is consistent with that for the $100 million proceeds received from the sale of our single-digit royalty interest on global net sales of TZIELD to DRI Healthcare Acquisitions LP in March of this year. Accordingly, $50 million was included in other income as a Gain on Royalty Monetization Arrangement for the quarter ended September 30, 2023.
Our net income was $17.6 million for the quarter ended September 30, 2023 compared to a net loss of $24.8 million for the quarter ended September 30, 2022. Our cash, cash equivalents and marketable securities balance as of September 30, 2023 was $256.4 million compared to $154.3 million as of December 31, 2022. Our cash balance as of September 30, 2023 did not include the $15.7 million milestone from Gilead subsequently received.
Finally, in terms of our cash runway, we anticipate that our cash, cash equivalents and marketable securities balance of $256.4 million as of September 30, 2023 the $15.7 million milestone subsequently received, 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 study, the Phase 2 LORIKEET study of lorigerlimab in metastatic castration-resistant prostate cancer as well as our other ongoing clinical and preclinical studies.
And now, I’ll turn the call back to Scott.
Scott Koenig
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, let me quickly remind you that since mid-2022, through our business development efforts as well as milestone achievements, we have received $335 million of non-dilutive capital. This includes $215 million from Provention, DRI, Sanofi in connection with TZIELD, $75 million from Gilead and $45 million from Incyte in connection with ZYNYZ.
Vobramitamab duocarmazine or vobra duo is our ADC designed to deliver a DNA-alkylating duocarmycin 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 under a modified study protocol during the second quarter. I am thrilled to tell you that we recently completed enrollment of this study ahead of schedule. As a reminder, TAMARACK is being conducted in patients with metastatic castration-resistant prostate cancer, or mCRPC, who have previously treated with one prior antigen receptor access targeted therapy. Participants may have received up to one prior taxing containing regimen but no other chemotherapy agent. This study is being conducted to evaluate vobra duo in patients across 2 experimental arms of either 2 mgs/per kg or 2.7 mgs/per kg every 4 weeks. We anticipate having data from the study to share with you in the first half of 2024.
Next, I will 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. We recently began enrolling the LORIKEET study of randomized Phase 2 clinical trial of lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naive mCRPC patients. A total of 150 patients are planned to be treated in the 2:1 randomized study. The current study design includes a primary study endpoint of radiographic progression-free survival or rPFS. Given that we just commenced enrollment, we’ll need more time to estimate when we might complete enrollment and have data to share from the study.
In addition, we continue to enroll patients in the Phase 1/2 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 in 2024.
Next up, MGD024 is our next-generation, bispecific CD123 CD3 DART molecule that incorporates 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 MGD024 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 MGD024 at predefined decision points during the Phase 1 study.
Also, as part of our collaboration with Gilead and as Jim already mentioned, we received a $15.7 million milestone from Gilead related to their nomination of the first of 2 potential research programs that leverage our DART and TRIDENT platforms for bispecific antibody. This nomination grants Gilead an exclusive option upon achievement of a predefined preclinical milestone to license worldwide rights to this first research program. MacroGenics will conduct the work related to this program on behalf of and funded by Gilead.
Next, enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3. Recently published data from a Phase 2 investigator-sponsored study of enoblituzumab in men with prostate cancer prompted our academic collaborators to initiate an investigator-sponsored randomized translationally intense prostate cancer clinical trial. The HEAT study is expected to commence enrollment in early 2024. And we’ll evaluate the activity of neoadjuvant enoblituzumab, given prior to radical prostatectomy in men with high-risk localized prostate cancer. Eligible patients will undergo a pre-treatment prostate biopsy and conventional imaging CT and bone scan as well as PSMA PET and optional prostate MRI as per institutional preferences.
Finally, on our second quarter earnings call, I described our ongoing efforts in developing preclinical ADC molecules utilizing linker payload technologies we licensed from Synaffix. I’m very pleased to tell you we recently submitted an investigational new drug or IND application to the U.S. FDA for the first of these ADCs MGC026. This molecule utilizes a topoisomerase inhibitor based cytotoxic mechanism directed against an undisclosed solid tumor target. In preclinical studies, the activity of this linker toxin combination compared very favorably with that of other topoisomerase inhibitor-based ADC technology. We look forward to sharing the preclinical data with you at a future scientific conference and telling you more about this molecule in early 2024. In addition to MGC026, we are readying a second topoisomerase inhibitor-based ADC for which we currently expect to submit an IND in late 2024. And behind these 2 ADCs, we are exploring additional molecules for potential future IND submission. Stay tuned.
To conclude, we believe we have 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.
We would now be happy to open the call for questions. Operator?
Question-and-Answer Session
Operator
[Operator Instructions] Our first question comes from Charles Zhu with Guggenheim Securities. Your line is open.
Charles Zhu
Hey, good evening guys and thanks for taking the question and congrats on the progress. Perhaps my first one here. How are you guys thinking about potential longer term registrational development for vobra duo within prostate cancer, particularly with, not only with the potential setting but also with the potential choice or choices of a control arm just given the current shifting landscape? Thank you.
Scott Koenig
Thanks for the question, Charles. So as you know, there has been some recent updates at the ESMO meeting with regard to PSMA-4. And clearly, we would like to see the results of the TAMARACK study, which as we described today, will occur earlier than we originally announced. We feel that there is great opportunity for treatment of patients in later line therapy. And we are evaluating now the potential options for a control population. These may include multiple choices by the investigator. But at this point, until we finish completion of the current TAMARACK study and have further discussions with the regulatory agencies, we will not provide guidance with regard to the specific control group. But it is clear from our interaction with key opinion leaders that this is a very, needed treatment advance for later line patients, giving them greater options than that are currently offered to them.
Charles Zhu
Got it. Great. Thanks for that. Maybe one quick follow-up on the vobra duo with the lorigerlimab combination, regarding the potential expansion cohorts starting from next year, which tumor types might you prioritize and why? And would you presumably also need to demonstrate contribution of components for this? And if so, would your current single-agent data suffice or would you need to demonstrate this data for each given individual histology? Thank you.
Scott Koenig
Well, as you know, Charles, we have now a significant data of individual treatment arms for vobra duo and lorigerlimab in prostate cancer, for example. So again, this would be a discussion with regards to the design of such study if we were moving forward with prostate. It is likely that prostate would be one of the expansion arms once we have established the final combination dosing for the individual components. As we have said previously, it is likely we will add one to two other tumor types in addition to prostate cancer. But at this time, we are not ready to describe the ones we have selected.
Charles Zhu
Great. Thanks for taking the questions.
Operator
[Operator Instructions] Next question comes from Kaveri Pohlman with BTIG. Your line is open.
Kaveri Pohlman
Hey, good evening. Congrats on the progress. So I guess my question is similar to the previous question that was asked for vobra. If you can just tell us how you are thinking about its development after readouts from TAMARACK trial in the first half of next year. Do you think you will have sufficient efficacy data to directly move into a pivotal study or you would be running another randomized trial?
Scott Koenig
Kaveri, the purpose of the current study was to fine-tune the dosing from what we had previously reported on the expansion dosing at 3 mgs/kg. Obviously, the data is still early in the feedback of the current trial. But I’m very pleased on how this trial has both enrolled and is performing. Clearly, we feel that we will be in a great position to select the dose for a control study, a Phase 3 study with one of those two doses. But at this point, as I described previously, we are not in a position to describe the other control arm. But I imagine it will look similar to what we had previously described in the Phase 2/3 original design last year.
Kaveri Pohlman
That’s helpful. And for lorigerlimab and docetaxel combination trial for chemo naive patients, how are you thinking about competition from radiopharmaceuticals? Are you allowing enrollment of patients who have gone through a defile like PSMA4/or eclipse regimen? And can bone marrow and kidney toxicities from these drugs provide a big market opportunity? And maybe a follow-up on that, do you think the prior use of atezo, if approved based on CONTACT-02 trial could impact lorigerlimab efficacy?
Scott Koenig
So, lots of questions there, the opportunities for patients who have been exposed to radiopharm is possible in the study of the lorigerlimab and docetaxel. As you know, this is a randomized study, 2 to 100 of the combo and 50 of the controlled docetaxel. We do believe that there will be great opportunities for patients. It expands the opportunity here despite the fact of encouraging data for pluvicto in the earlier line therapy. Clearly, we are not curing these patients even from that treatment. As you know, there was some question with regard to the overall survival benefit because of the high crossover of pluvicto. And certainly, there will be challenges for patients who have a history of bone marrow toxicities from the radiopharmaceutical or from other agents going forward. Clearly, at this point, we’re still in the early phases of enrolling in this study. And we’ll have more to speak about this in 2024. I didn’t catch your last question. Could you repeat that one?
Kaveri Pohlman
Yes. So if you think that atezo, if it gets approved based on the CONTACT-02 trial, do you think it could impact lorigerlimab efficacy?
Scott Koenig
I don’t think that that’s going to be a – that the activity of lorigerlimab based on the data we report to-date should have a superior outcome in various prostate settings.
Operator
[Operator Instructions] Our next question comes from Etzer Darout with BMO Capital Markets. Your line is open.
Etzer Darout
Great. Thanks for taking the question. Just a couple of quick ones. So the first one; just was curious Scott, how much overlap a trial site overlap you have between TAMARACK and sort of the LORIKEET trial? And could we sort of see maybe a similar sort of trajectory in terms of enrollment for that study if sites are sort of similar between those two studies? And then, for the vobra lori dose for the combination, just curious as to sort of maybe where you are currently with the dose with the dark escalation and sort of the drivers here for the expansion start in 2024? Thanks.
Scott Koenig
Okay. Actually, you cut out, let me answer the first question, which was on the trial overlap. There is, some sites that are enrolling in both studies, but largely separate sites. But I think we’re in very good shape with the current sites that are set-up for LORIKEET to have a good enrollment in late this year and into ‘24, but clearly, still [Technical Difficulty]
Etzer Darout
Are you still there, Scott?
Jim Karrels
Scott, you faded out. Would you mind answering that again?
Scott Koenig
Okay. I didn’t hear the second question with regard to [Technical Difficulty] for the trial.
Etzer Darout
Can I ask the second question or?
Scott Koenig
Yes, please.
Etzer Darout
Yes. So just was curious sort of where you are with sort of the vobra lori dose escalation in sort of the push and pull here for the start of the expansion trial in 2024? [Technical Difficulty]
Operator
[Operator Instructions] Are you back, Scott?
Scott Koenig
Hello.
Jim Karrels
Your back. Now, Scott, we can hear you.
Scott Koenig
Okay, I switched computers.
Etzer Darout
Yes. We can hear you. Should I ask the question again? I’m not sure if you heard?
Scott Koenig
Please. No, I didn’t hear.
Etzer Darout
No, just curious to see sort of where you were with the dose escalation of the lori vobra combination? What sort of triggers here the expansion start in 2024, if you can just maybe provide a little bit more color on where you are with the escalation?
Scott Koenig
Yes. We’re pretty close to selecting the doses now. We are fine-tuning the individual doses. We expect that to occur by the end of the year and then would move into the expansion in early ‘24.
Etzer Darout
Got it. Thank you.
Operator
[Operator Instruction] Our next question comes from Jon Miller with Evercore. Your line is open.
Jon Miller
Hey, guys. Thanks so much for taking my question and congrats on all the progress. I guess one on LORIKEET. This is a phase – randomized Phase 2 here. But you were previously guiding to a Phase 2 expansion after the ongoing Phase 1. Are we still expecting to see a meaningful mCRPC data set here in an expansion setting in first half ‘24 or is this taking the place of that? And then secondly, on the 024 program, are Gilead opt-ins, I mean I know they’re at unspecified points in Phase 1, but are we going to see public-facing data from that Phase 1 before Gilead has opt-in rights or is it possible they have opt-in rights before even Phase 1 data is available?
Scott Koenig
So let me start with the second one. They can opt in any time during Phase 1. And they will control the data with regard to public presentation. But they can have – they have to do it before the data Phase 1 is complete. With regard to the LORIKEET and the expansion study, that study is complete, but for the fact that several of the patients, three of the patients are still on lorigerlimab. This is now coming on almost 2 years from enrollment and that’d be encouraged by the activity and the ability to retreat patients over long periods of time. With regard to the LORIKEET Phase 2, the plan is to complete that study makes not only for the chemo-naive population but also look at the opportunity of LORIKEET in other prostate setting, as we have described is opportunities to test this in other tumor settings and we should provide some updates very soon with regard to additional indications that we would like to pursue with lorigerlimab.
Jon Miller
Great. Thanks for the color there, Scott, but maybe I missed it. Are we still expecting a lori expansion-update an actual data set coming first half next year?
Scott Koenig
Well, from the prostate study that we presented that, as you know, last February, there is, for that particular cohort, just the longevity of prostate with regard to the non-prostate indications, what we have said is that once we have decided to move forward with other indications, they may provide opportunities to present the data from which we based the decision to move forward.
Jon Miller
Okay, thanks so much. And maybe one on the deeper pipeline then. You mentioned the topo payload on 026. But you previously talked about multiple payloads and linkers. So how diverse are those next couple of molecules that you mentioned coming just behind 026? Are they also representative of that multiple payloads, multiple linkers programs that you’ve got?
Scott Koenig
So we continue to look at the options. This will be in terms of the linker payload and because the way the Synaffix biospace there and toxin is set up, we can select one of several. What we’ve said that the first one is a topoisomerase inhibitor. The second one will be a topoisomerase inhibitor. We’re evaluating not only a topoisomerase inhibitor but other toxins associated with other targets going forward, but are not in a position yet to discuss either the targets or the particular payloads that we’ll use for the number 3, 4 or beyond.
Jon Miller
Thanks so much, guys.
Operator
[Operator Instructions] Our next question comes from Peter Lawson with Barclays. Your line is open.
Peter Lawson
Thanks, Scott. Thanks for taking the questions. Just on TAMARACK, why did that enroll faster than expected? And how much data should we expect to see from that in the first half since next year?
Scott Koenig
Well, I have to say that [Technical Difficulty] Europe and the U.S. and in Asia. We saw a great enthusiasm for the [Technical Difficulty] patients on the study. I can’t give you any more color than they have to have in the opportunity here with vobra duo in helping their patients. And the rationale why we’re doing that that was resonated very well with the investigators as well as the patients. What the study was originally included as 100 patients, 50 in each arm. We’ve actually exceeded that. It was an overworked study. So we expect a fairly sizable amount of data to come out in 2024.
Peter Lawson
Okay. And then on ADAM9, any details why that readout was nudged back from second half of this year to ‘24?
Scott Koenig
The study is completing – is being completed out, finalizing. And we’ll – as ImmunoGen has said, they will report out in the beginning part of ‘24. As I’ve indicated to you, one of the challenges has been always with identifying the appropriate dose moving forward. They are finishing out the patients that are in the non-small cell lung cohort currently. And we will report on that in the first part of the year and with regard to next steps for that program.
Peter Lawson
Great. Okay, thanks so much.
Operator
Our next question comes from Silvan Tuerkcan with JMP Securities. Your line is open.
Silvan Tuerkcan
Hi, good evening. Congrats on the update. And thanks for taking my questions. Maybe a more big picture question. Can you comment maybe on some key takeaways from ESMO and SITC on B7-H3 as a checkpoint that more and more presentation also what we can learn from the Daiichi Merck partnership. And then the second question is; what is your role in the HEAT study on ENA? I know that investigator related and its earlier stage prostate cancer. But what is your role here and what’s your involvement?
Scott Koenig
Thank you. So with regard to the data from ESMO, first of all, as you commented on the partnership now with Daiichi, cohort includes 7300 molecule. I have to think that we’re very encouraged that the way that that partnership was constructed. And the value that Merck placed on that relationship is 7300 was being a very important part of the three target deal. It only heightens I think the value we see for vobra duo and our B7-H3 program. With regard to the specifics that they did that, Daiichi presented in their poster session. If you recall, it was a lot more in terms of improved activity in the prostate cohort that they tested. They were seeing about 5 months of our PSS as first reported about a year of vobra duo and a 25% PSA50 response. The latter of which is not any different than previous reported.
So we feel, again, very good about where vobra duo sits right now. Having this additional data that will come out to in ‘24 on the TAMARACK study to be able to move forward very effective drug with a proper dosing to mitigate some of the side effects we were seeing. With regard to the HEAT study, again, we have always had a very close relationship with and had a lot of funding with discussions with them on where the value we see lorigerlimab in settings like a neoadjuvant use of this drug. And we’re also rent also looking at opportunities for enoblituzumab in other settings as well. With regard to this being a collaborative study, it is mostly an IST. So they have full control over the execution and providing the data. But we have constant conversations back and forth with – regarding the opportunity for a noble, and other B7-H3 molecules in the gene prostate cancer.
Silvan Tuerkcan
Thank you.
Operator
[Operator Instructions] Our next question comes from Jonathan Chang with Leerink Partners. Your line is open.
Faisal Khurshid
Hi, guys. This is Faisal on for Jonathan. Thanks for taking our questions. So congrats on the TAMARACK enrollment. I guess now that you sort of know what kind of patients you’ve enrolled, what do you see as the right benchmarks for vobra duo in this setting?
Scott Koenig
Well, I mean, as I indicated that we were looking to achieve a similar range of activity based that we had previously, where we were seeing about half the patients achieving PSAs. I said we would look for a 40% to 60% range on PSA50 and obviously, looking hopefully for some of these patients that PSA50 with regard to the objective responses here. Again, we have reported and what I just described to Daiichi with approximately a quarter of those patients have objective responses without delay, even higher levels. And we think that there is an opportunity there given how we have improved these patients will stay on drug potentially longer when they don’t have to come off for side effects that are problematic for them. With regard to rPFS, so again, when we look to the historical data on both Pavecto and [indiscernible] etcetera. Again, as I just reported to you with rPFS from the 7300 in the range of 5 months, we obviously would be looking hopefully for longer rPFS in the 6 months or greater. So I would say those are sort of general ranges. Nothing absolute here with regard to decisions, the totality of the data, which will decide our next steps for this program.
Faisal Khurshid
Got it. That’s super helpful. Thank you. And then recently, there was data presented for PSMA ADC and also a steep on T-cell engager like Phase 1 data in prostate cancer. Just curious your thoughts on the competitive landscape and how you see your assets positioned?
Scott Koenig
Well, I think actually we are in wonderful shape. We are managing the opportunities for patients. For PSMA ADC, if you look at the data that has been presented at various meetings, the actual spread patterns of PSMA and B7-H3 are not identical. They overlap the consumers. But there are clearly select parts of the tumors, which will express one or the other. As I pointed to that previously, as patients’ progress to latter line, PSMA tends to drop significantly where B7-H3, are maintained. So, we think that it provides greater opportunity and choices for treating, particularly older age patients. But most importantly, with regard to this particular program or having an ADC for ADC versus an ADC for PSMA, PSMA is going to be largely limited to product, where with a broad expression of B7-H3 across most solid tumors, I think that we are in a great opportunity not only to improve treatment for patients with prostate cancer, but through a whole set of other tumors. With regards to other platform technologies, again, none of the data I see in that’s overwhelming in that regard. But again, we will have to see how that pans out. In most of these cases, again, the point I was making with regard to the PSMA specificity, it will limits the prostate cancer.
Faisal Khurshid
Thank you.
Operator
[Operator Instructions] Our next question comes from Yigal Nochomovitz with Citi. Your line is open.
Unidentified Analyst
Hi guys. This is Atif Malik [ph] on Yigal. Thanks for taking my questions and congrats on all the progress. Just a couple of quick ones. Will there be an interim look in LORIKEET? And if so, what might trigger that interim look? Also curious if you are able to share any color on powering assumptions and remind us what the trial is designed to show in terms of separation rPFS between the arms. Thanks.
Scott Koenig
So, there is a [Technical Difficulty] LORIKEET will likely be a futility analysis. We have not provided the statistics around that. But I should point out that historical data in multiple control trials in chemo-naïve population has shown rPFS is around eight months. So, we are talking on this to be able to beat that milestone and that landmark.
Unidentified Analyst
Okay. Got it. And then maybe one on MGD024, I guess can you remind us what you would view as an acceptable CRS profile for this program? And then maybe on the efficacy side, what you would see as a worthwhile complete response rate in the Phase 1 dose escalations that have been in the move into expansion of Phase 2? Thanks.
Scott Koenig
Well, as you know, this is a study, as we pointed out, that has to-date with Gilead. So, I can’t speak to them in terms of what their bar for the study. But we have described historically in late-line patients with the enoblituzumab that the precursor of this molecule. We were seeing at that [Technical Difficulty] in the primary induction value population north of 20% response rates of the control arm [ph]. Clearly, we would like to see higher rates. As now, we think that we have both a basis on the reduced CRS profile and as well as the ability to get this dosing on an intermittent basis and intermittent infusion. With regard to the specific tolerance for safety profile, clearly in kind of the absence or markedly reduced low-grade CRS and limiting it to intently initial dosing and later dosing would be, I think a favorable profile that allows the use both in early line and late line patients. But again, this is a decision that Gilead would make based on their expectations.
Unidentified Analyst
Okay. Got it. And then last one for me, just a very high level. We are just wondering if you received a lot of inbounds for potential partnerships on with Vobra Duo. And if so, maybe when you entertain partnerships, would that be more around the Phase 3, or is that something you would rather do sooner rather – sooner rather than later?
Scott Koenig
So, the answer is we have had very encouraging discussions historically about Vobra Duo with many large companies, both pharma and biotech companies. What we have described to them is our interest in getting additional data in the TAMARACK study before we would engage in further discussions on potential partnerships. Back to the point I was making earlier because of the efficacy here for Vobra Duo to treat many, many different tumors that is something we as MacroGenics did ourselves. And so at the appropriate time, I would envision if development continue to iterate in aerosols which would both expand the opportunity not only in prostate cancer, but other tumor types as well with a partner who has the resources and capabilities to support it along with us.
Unidentified Analyst
Got it. Very helpful. Thanks very much.
Operator
[Operator Instructions] Our next question comes from Stephen Willey with Stifel. Your line is open.
Stephen Willey
Yes. Good afternoon. Thanks for taking the questions. Maybe just a quick one on the next-gen ADC efforts, and Scott, I know you are not going to be disclosing target antigens anytime soon. But just wondering philosophically how you are kind of thinking about selecting target antigens for this next round of ADCs that you put into the clinic? And I guess how far out on the risk curve are you willing to step considering you are tethering a novel linker and payload to these things? And I guess when you declare the target for the first candidate, the first half of next year, is this something that we should expect to fall into kind of the highly competitive buckets of ADC antigens that we have seen across the landscape or is this thing going to be kind of maybe a little bit more differentiated and unique? Thanks.
Scott Koenig
Thanks Steve. And we put a lot of discussion in the selection of both the targets as well as the linker payloads. Clearly, there is lots of competition or we want to be thoughtful in the selection of both. We feel that [Technical Difficulty] given what Synaffix has already shown with regard to what we believe is superior platform, the ability of using a DART in this case, close to four [indiscernible] exatecan in various configurations and our own preclinical data showing the favorable aspects of this. With regard to the specific targets, I think what you will be pleased to see is, I would say, a mixture of markets that are validated to some degree, but not necessarily have any approved products in the market, where we can be very competitive. There is opportunities for clearly novel targets that will help in pursuing. And in some cases where there is some scanty data and we nowhere pursued, but have been disappointing, which could be described due to the design of the particular molecules that have been tested. So, I think over the first half or the next six months, you will certainly see the first look at some of these targets of presentations at scientific meetings. And then later in ‘24 and going on in ‘25, we will be adding on more of these targets. And I think that the pace we are at right now is a quite favorable where we are pushing the team to be able to have a new IND on an annual or a slightly longer basis. So, that would provide both opportunities for organic growth, but also given the importance of bringing in non-dilutive capital, the opportunity for partnerships there. I should also point out that because Synaffix also has partnerships with other companies, they are going to using their linker toxins. So, having that validation of early – later this year Stage 4 from other molecules as well as our own will give a lot more encouragement for the value of that.
Stephen Willey
Great. Thanks for taking the question.
Operator
[Operator Instructions] And I am not showing any further questions at this time. I would like to turn the call back over to Scott for any closing remarks.
Scott Koenig
Well, thank you, operator, and thank you all for joining today. We look forward to providing updates in 2024, both on our clinical and preclinical studies. I hope you have a good day.
Operator
Ladies and gentlemen, this does conclude today’s presentation. You may now disconnect and have a wonderful day.
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