MGNX earnings name for the interval ending September 30, 2024.
Picture supply: The Motley Idiot.
MacroGenics (MGNX 1.89%)
Q3 2024 Earnings Name
Nov 05, 2024, 4:30 p.m. ET
Contents:
- Ready Remarks
- Questions and Solutions
- Name Individuals
Ready Remarks:
Operator
Good afternoon. We’ll start the MacroGenics 2024 third-quarter company progress and monetary outcomes convention name in only a second. All contributors are on a listen-only mode in the meanwhile, and we’ll conduct a question-and-answer session on the conclusion of the decision. At this level, I’ll flip the decision over to Jim Karrels, senior vice chairman and chief monetary officer of MacroGenics.
James Karrels — Senior Vice President, Chief Monetary Officer, and Secretary
Thanks, operator. Good afternoon, and welcome to MacroGenics’ convention name to debate our third quarter 2024 monetary and operational outcomes. For anybody who has not had the prospect to evaluate these outcomes, we issued a press launch this afternoon outlining at this time’s bulletins. This launch is out there below the Buyers tab on our web site at macrogenics.com.
You may additionally take heed to this convention name through webcast on our web site, the place will probably be archived for 30 days starting roughly two hours after the decision is accomplished. I wish to alert listeners that at this time’s dialogue will embrace statements concerning the firm’s future expectations, plans, and prospects that represent forward-looking statements for functions of the secure harbor provision below the Personal Securities Litigation Reform Act of 1995. Precise outcomes could differ materially from these indicated by these forward-looking statements because of varied necessary components, together with these mentioned within the Threat Components part of our annual, quarterly, and present stories filed with the SEC. As well as, any forward-looking statements characterize our views solely as of at this time and shouldn’t be relied upon as representing our views as of any subsequent date.
Whereas we could elect to replace these forward-looking statements in some unspecified time in the future sooner or later, we particularly disclaim any obligation to take action, even when our views change, besides to the extent required by relevant legislation. And now, I might like to show the decision over to Dr. Scott Koenig, president and chief government officer of MacroGenics.
Scott E. Koenig — President, Chief Govt Officer, and Director
Thanks, Jim. I might wish to welcome everybody collaborating through convention name and webcast at this time. I’ll present key updates on our medical applications this afternoon. However earlier than I achieve this, let me first flip the decision again to Jim, who will evaluate our monetary outcomes.
James Karrels — Senior Vice President, Chief Monetary Officer, and Secretary
Thanks, Scott. This afternoon, MacroGenics reported monetary outcomes for the quarter ended September 30, 2024, which highlights our monetary place. As described in our launch this afternoon, MacroGenics’ complete income was $110.7 million for the quarter ended September 30, 2024, in comparison with complete income of $10.4 million for the quarter ended September 30, 2023. The rise was primarily because of $100 million in milestones obtained from Incyte in August associated to retifanlimab.
Our analysis and improvement bills had been $40.5 million for the quarter ended September 30, 2024, in comparison with $30.1 million for the quarter ended September 30, 2023. The rise was primarily because of elevated analysis and improvement prices associated to the corporate’s preclinical ADC pipeline of vobra duo and the TAMARACK medical trial. Our promoting, common, and administrative bills had been $14.1 million for the quarter ended September 30, 2024, in comparison with $12.4 million for the quarter ended September 30, 2023. The rise was primarily because of elevated stock-based compensation expense {and professional} charges.
Our web earnings was $56.3 million for the quarter ended September 30, 2024, in comparison with web earnings of $17.6 million for the quarter ended September 30, 2023. Internet earnings for the quarter ended September 30, 2024, included the aforementioned $100 million in milestones from Incyte. Internet earnings for the quarter ended September 30, 2023, included a $50 million milestone cost from Sanofi associated to the beforehand disclosed achievement of a major endpoint in a TZIELD medical examine, which was recorded in different earnings. Our money, money equivalents, and marketable securities stability as of September 30, 2024, was $200.4 million in comparison with $229.8 million as of December 31, 2023.
The stability of September 30, 2024, didn’t embrace the $40 million upfront cost anticipated from the closing of the MARGENZA transaction or the $8 million modification price we plan to pay our present commercialization associate. Lastly, by way of our money runway. According to our prior steerage, we anticipate that our money, money equivalents, and marketable securities stability of $200.4 million as of September 30, 2024, plus the $40 million upfront cost anticipated from TerSera associated to the MARGENZA transaction, much less an $8 million modification price we anticipate to pay our present commercialization associate, along with projected and anticipated future funds from companions ought to present a money runway into 2026. Our anticipated funding necessities mirror anticipated expenditures associated to the continuing Section 2 TAMARACK and LORIKEET research in addition to our different ongoing medical and preclinical research.
And now, I will flip the decision again to Scott.
Scott E. Koenig — President, Chief Govt Officer, and Director
Thanks, Jim. We proceed to consider our proprietary pipeline of product candidates has nice promise, and I’ll stroll you thru every of our key applications. Vobramitamab duocarmazine, or vobra duo, is our ADC designed to ship a DNA-alkylating duocarmycin cytotoxic payload to tumors expressing B7-H3. B7-H3 is a member of the B7 household of molecules concerned in immune regulation.
Vobra duo is designed to benefit from this antigen’s broad expression throughout a number of strong tumor sorts. We proceed to consider B7-H3 has the attributes of a perfect most cancers goal. The TAMARACK Section 2 examine is being performed in mCRPC sufferers who’ve beforehand obtained an androgen receptor entry focused brokers and as much as one prior taxane-containing routine however no different chemotherapy. Whereas examine contributors are now not being dosed within the trial, contributors proceed to be monitored for antagonistic occasions, illness development, and survival.
The examine’s major endpoint is radiographic progression-free survival, or rPFS. Provided that solely 65 PSF occasions or 35.9% had accrued as of the July 9, 2024, knowledge cutoff, the interim medium rPFS estimates offered on the ESMO Congress in September had been immature. And since these outcomes had been immature, we consider they’re prone to change as further occasions accrue. We anticipate to have mature median rPFS in hand no later than early 2025.
Evaluation of future improvement options for vobra duo will likely be primarily based on a number of components, together with the ultimate TAMARACK security and efficacy knowledge in mCRPC, a evaluate of the aggressive therapy panorama for mCRPC, useful resource allocation throughout our medical portfolio, in addition to potential partnering alternatives for vobra duo. Till we full our evaluation of the monotherapy improvement alternative in mCRPC, now we have paused our different improvement efforts in various tumor sorts in addition to the Section 1/2 dose mixture examine of vobra duo plus lorigerlimab. Recall that now we have two different medical molecules that focus on B7-H3. The primary, MGC026, is an investigational ADC incorporating a novel topoisomerase 1 inhibitor-based linker payload, SYNtecan E, which we licensed from Synaffix.
Our second further B7-H3-directed molecule is enoblituzumab, the investigational Fc-optimized monoclonal antibody. MGC026 incorporates a linker payload primarily based on exatecan, a clinically validated and potent camptothecin that readily combines with Synaffix’s hydrospace expertise. We initiated a Section 1 dose escalation examine of MGC026 early this yr in sufferers with superior strong tumors. The variable area of the molecule concentrating on B7-H3 for MGC026 is identical sequence contained in vobra duo.
We view the MGC026 as a complementary method to vobra duo for concentrating on B7-H3. Extra particularly, we consider that having distinct mechanisms of motion and doubtlessly completely different security and efficacy profiles, vobra duo and MGC026 could handle completely different cancers, tumor levels or be utilized in mixture with alternate brokers or doubtlessly with each other to reinforce their medical utility. We stay assured within the potential of concentrating on the B7-H3 pathway whatever the mechanism of motion or payload. Relating to enoblituzumab, our educational collaborators are enrolling the HEAT examine an investigator-sponsored, randomized Section 2 examine of this molecule in as much as 219 males with prostate most cancers.
Subsequent, I will replace you on lorigerlimab, our bispecific tetravalent PD-1 x CTLA-4 DART molecule. We designed lorigerlimab to have preferential blockade on twin PD-1 CTLA-4 expressing cells, akin to tumor-infiltrating lymphocytes, or TILs, that are most considerable within the tumor microenvironment. We’re enrolling the LORIKEET examine, a randomized Section 2 medical trial of lorigerlimab, together with docetaxel versus docetaxel alone in second-line chemotherapy naive and CRPC sufferers. The present examine design contains the first examine endpoint of rPFS.
A complete of 150 sufferers are deliberate to be handled in a two-to-one randomized examine with greater than 100 examine contributors enrolled up to now. We anticipate finishing enrollment of the examine late this yr or early 2025 and offering a medical knowledge replace on the examine within the first half of 2025. MGD024 is our next-generation bispecific CD123 by CD3 DART molecule that includes a CD3 part designed to reduce cytokine launch syndrome whereas sustaining anti-tumor cytolytic exercise and allowing intermittent dosing by means of an extended half-life. Our Section 1 dose escalation examine of MGD024 is ongoing in sufferers with CD123-positive relapsed or refractory hematologic malignancies, together with acute myeloid leukemia and myelodysplastic syndromes.
Recall that Gilead has the choice to license MGD024 at predefined choice factors through the Section 1 examine. MGC028 is our second topoisomerase 1 inhibitor-based ADC incorporating Synaffix’s novel linker payload and an ADAM9 concentrating on antibody. ADAM9 is a member of the Adams household of multifunctional sort 1 transmembrane proteins that play a job in tumor genesis and most cancers development and is overexpressed in a number of cancers, making it a gorgeous goal for most cancers therapy. We not too long ago submitted an investigational new drug utility for MGC028 to the U.S.
FDA. Past MGC028, we’re exploring further molecules for potential future IND submission. I sit up for telling you extra about these further molecules on future calls. Lastly, after quarter-end, we bought international rights to margetuximab, which is marketed as MARGENZA, to TerSera Therapeutics LLC, a privately held biopharmaceutical firm, pursuant to an settlement introduced just a few weeks in the past.
TerSera is predicted to pay us $40 million at closing, and we could obtain further gross sales milestone funds of as much as an combination of $35 million. The transaction is predicted to shut within the fourth quarter of 2024, topic to customary closing circumstances. We anticipate to pay an $8 million modification price to our present commercialization associate through the fourth quarter of 2024 and can manufacture MARGENZA drug substance on behalf of TerSera going ahead. The pending margetuximab transaction, in addition to the not too long ago obtained $100 million in milestones from Incyte, additional strengthen our monetary place, enabling us to sharpen our deal with our key priorities of advancing our clinical-stage property whereas researching and creating the following wave of early stage product candidates.
Thanks all for becoming a member of at this time. As you recognize, we introduced final week that I will likely be stepping down as President and CEO early subsequent yr. After practically 25 years with MacroGenics, it is actually a milestone for me personally and professionally. Collectively, we have remodeled concepts into remedies, constructing a totally built-in biotech firm devoted to serving to sufferers.
I am immensely happy with what we have achieved, notably the development of therapeutics like MARGENZA, ZYNYZ, and TZIELD to FDA approval and our sturdy pipeline of antibody-based remedies. This transition comes at a time when MacroGenics is strongly positioned with a various and promising improvement portfolio and a strong monetary basis. The board has initiated a considerate seek for my successor, and I’m dedicated to supporting the corporate throughout this era to make sure a seamless transition. Trying forward, I’m assured in MacroGenics’ future.
Our near-term objectives stay unchanged: advancing our pipeline, increasing partnerships, and creating worth for sufferers and shareholders alike. I need to thank the MacroGenics staff, our board, our shareholders, and our companions for his or her dedication. I sit up for persevering with my help as an advisor and shareholder, and I am excited to see all that MacroGenics will accomplish in its subsequent chapter. We might now be glad to open the decision for questions.
Operator?
Questions & Solutions:
Operator
Thanks. [Operator instructions] Please stand by whereas we compile the Q&A roster. Now, first query coming from the road of Tara Bancroft with TD Cowen. Your line is now open.
Unknown speaker — — Analyst
Hey, guys, that is Nick on for Tara. Thanks for taking our query. Only one for me, however I perceive the parameters factoring into your excision will likely be a number of for this. However what do you have to particularly see from the info subsequent yr to decide about going ahead or not for vobra duo? And do you’ve gotten any up to date ideas on the potential dose at this level? Thanks.
Scott E. Koenig — President, Chief Govt Officer, and Director
Thanks very a lot, Nick. As we stated, we’re near getting the ultimate knowledge. As we have famous, we continued the remark of those sufferers put up the final dosing, which occurred in July. The sufferers will likely be adopted now not than six extra months.
As I identified, the variety of parameters to have a look at, clearly, wanting on the last rPFS, wanting on the security profile of the drug, wanting on the aggressive panorama, and assessing this within the context of different issues now we have in our portfolio. It is simply too early at this level to offer the particular parameters which is able to decide subsequent steps ahead. So, be affected person, and we should always be capable to present some insights within the coming months.
Unknown speaker — — Analyst
Thanks very a lot.
Operator
Thanks. Our subsequent query coming from the road of Jonathan Chang with Leerink Companions. Your line is now open.
Jonathan Chang — Leerink Companions — Analyst
Hello, guys. Thanks for taking my questions. And naturally, finest needs to Scott. First query, on that time, are you able to present any shade across the search course of for the following CEO? And the way we needs to be fascinated by timelines for the transition? After which second query, on MGC026, your second B7-H3 ADC program.
Are you able to talk about how the Section 1 dose escalation is progressing? And when might buyers see preliminary medical knowledge from that program? Thanks.
Scott E. Koenig — President, Chief Govt Officer, and Director
First, Jonathan, thanks very a lot. It is all the time been a pleasure working with you. When it comes to the search course of, because the announcement occurred final week, the — there’s a subgroup of the board that has been chosen to provoke the method whereas a search committee goes to be working with an out of doors agency, and that course of is simply getting began. The expectations, as I stated, is that I’ll keep on.
We’ll proceed with the technique now we have adopted and transfer the applications ahead till the brand new CEO is chosen. It is anticipated. Clearly, this stuff take just a few months. I’ll keep on till the brand new CEO is chosen so there needs to be a clean handoff to anybody when that individual comes on board.
With regard to the 026 examine, we’re in the course of dose escalation. The examine goes fairly nicely. We’re moving into ranges proper now. One may anticipate the start of responsiveness.
The expectation right here is that we might start — we might full this examine in ’25 and be capable to report the info out in ’25.
Jonathan Chang — Leerink Companions — Analyst
Understood. Thanks for taking the questions.
Operator
Thanks. And our subsequent query coming from the road of Yigal Nochomovitz with Citi. Your line is now open.
Unknown speaker — — Analyst
Hello. That is Reena on for Yigal. I simply needed to ask what sort of triggered the choice to halt the combo now versus earlier when the choice was seen to cease dosing sufferers in TAMARACK. And should you might present any extra particulars on the colour on pausing the lorigerlimab combo with vobra, what number of sufferers had been dosed? Had been there any points harking back to what we have seen within the vobra monotherapy? Or simply any further shade you might need there?
Scott E. Koenig — President, Chief Govt Officer, and Director
Thanks very a lot for the query. As you recognize, we had proceeded with the combo examine to the purpose the place we had been very snug with the doses that had been achieved within the populations we had been analyzing with the person lorigerlimab and vobra together. Nevertheless, as we identified, is that we’re wanting on the last knowledge for TAMARACK developing within the subsequent couple of months. We might have a look at the opportunity of exploring further research in vobra to fine-tune that, if applicable.
And due to this fact, relatively than proceed shifting ahead and expansions with the doses that we had already examined together, we needed to get that last evaluation of the suitable vobra dose earlier than we might then discover combos going ahead. So, it is a judgment that we need to finally have one of the best dose going ahead if we proceed mixture research.
Unknown speaker — — Analyst
OK. That is smart. Thanks for taking my query.
Operator
Thanks. And our subsequent query coming from the road of Etzer Darout with BMO Capital Markets. Your line is now open.
Etzer Darout — BMO Capital Markets — Analyst
Thanks for taking the query. Only one query for me on MGC026. Simply marvel, given now you’ve got evaluated vobra duo preclinically and within the clinic. You have gotten a preclinical evaluation of MGC026.
In the event you’re seeing any notable variations within the profile for these two ADCs from a security perspective and the way that profile might be differentiated from vobra on form of security? Thanks.
Scott E. Koenig — President, Chief Govt Officer, and Director
Thanks, Etzer. One would anticipate that, clearly, with vobra being a DNA-alkylating agent and the 026 being a topo 1 inhibitor, one will see distinct security profiles. As I’ve stated, we need to get the ultimate security. We clearly achieved a lot with the TAMARACK examine with decreasing the doses there.
However at this level, being solely in the course of dose escalation on 026, I can not provide you with a side-by-side comparability of the 2. There will likely be distinct variations in security, nevertheless it’s simply too early to spell out the specifics at this level.
Etzer Darout — BMO Capital Markets — Analyst
Thanks.
Operator
Thanks. Our subsequent query coming from Jon Miller with Evercore ISI. Your line is now open.
Jon Miller — Analyst
Hello, guys, thanks for taking the query, and I will echo my respect for Scott, and as you’ve got heard earlier than, nice to work with you for all these years. I might additionally like to ask concerning the vobra-lori combo that you simply’re pausing. What number of sufferers have you ever dosed there? How a lot knowledge do you’ve gotten? And is there any likelihood we might see that knowledge? Perhaps across the similar time that lori is popping out or within the close to time period at any price? And perhaps from a LORIKEET perspective, how do you view the panorama for lori combos going ahead from right here, whether or not it is with vobra duo or with different ADCs in prostate?
Scott E. Koenig — President, Chief Govt Officer, and Director
Yeah. Thanks a lot, Jon. I actually recognize the non-public feedback. It’s a pleasure to be working with you and your colleagues as nicely.
With regard to the variety of sufferers, we did many — and the precise particular numbers I can not reply to you off the highest of my head. However is within the double digits. When it comes to taking a look at a number of doses, this was a three-plus-three evaluation at varied combos. However after all, as a result of we had been enrolling sufferers with completely different tumor sorts, the illustration of any specific tumor sort was fairly small.
So, at this level, we’ve not assessed the type of presenting the info now we have there may be extra possible that, as I stated earlier, we need to assess the ultimate outcomes of TAMARACK, make some selections, whether or not we want additional alterations of the vobra dosing if we proceed with the mixture research going ahead. With regard to the chance with lorigerlimab, as you recognize, we’re doing the LORIKEET examine together with docetaxel. And as I famous earlier, that examine will fully enroll by the tip of the yr or very early in ’25. So, we’ll have knowledge on ’25 on that.
And we’re taking a look at alternatives of mixing lorigerlimab and different medical settings, not solely in prostate most cancers, with different brokers, nevertheless it’s, once more, too early to evaluate that till now we have the ultimate knowledge on the LORIKEET examine.
James Karrels — Senior Vice President, Chief Monetary Officer, and Secretary
Let me simply add to that, simply in case it wasn’t fully clear to listeners. So, the — with regard to vobra plus lori, that mixture, we have solely studied that in dose escalation. We had thought we might transfer into dose growth later this yr. Clearly, we didn’t do this.
So, all of our knowledge comes from dose escalation, and the dose growth examine was by no means truly commenced.
Scott E. Koenig — President, Chief Govt Officer, and Director
Yeah. As Jim was declaring, once more, it was a three-plus-three design in taking a look at that.
Operator
Thanks. And our subsequent query coming from the road of Kelsey Goodwin with Guggenheim Companions. Your line is now open.
Unknown speaker — — Analyst
Hello, that is Brittany on for Kelsey. Thanks for taking our questions concerning the LORIKEET trial and the replace that is coming within the first half of subsequent yr by way of the benchmark there and what could be thought of.
Scott E. Koenig — President, Chief Govt Officer, and Director
Yeah. Thanks very a lot with regard to the LORIKEET examine. You had been slightly mushy on the sound right here. I simply need to make sure that all people understood what the query was.
Clearly, we’re wanting right here at a chemo-naive inhabitants. As you recognize, should you have a look at the usual of care of docetaxel alone, should you have a look at the final three research the place docetaxel was examined, it is roughly eight to eight.6 months of rPFS profit. Clearly, we wish to see a major improve, each in rPFS after which finally, clearly, have a profit seen in OS, the precise quantity. We’re not ready to declare at this level, however definitely could be in a — for rPFS, will likely be definitely in a double-digit months of enchancment.
Operator
Thanks. And our subsequent query coming from the road of Silvan Tuerkcan with Residents JMP. Your line is open.
Silvan Tuerkcan — Analyst
Yeah. Thanks. Thanks for taking my query. And Scott, thanks for working with us.
It was nice to work with you. I’ve a query on MGD024. You have talked about that Gilead has some opt-in at varied factors all through this trial, and it’s ongoing, and chances are you’ll or could not get knowledge subsequent yr. However are any of these factors subsequent yr — might we discover out subsequent yr for the choice or not? Thanks.
Scott E. Koenig — President, Chief Govt Officer, and Director
Yeah. You already know, it is — thanks very a lot, once more, to your private feedback. With regard to the examine, it is continuing nicely. As you recognize, with an energetic redirected T-cell killing molecules, the FDA place is that one requires sluggish dose escalation.
And we have been by means of many, many cohorts already, and we’re persevering with to dose escalate right here. So, I can not, at this level, decide when the examine will likely be accomplished. It’s shifting ahead. And nor can I decide when Gilead may make the choice with regard to opting in.
They’ve the flexibility to attend till the tip of the Section 1 knowledge. So, at this level, although, now we have an excellent collaboration. We share the info with them, and we anticipate that the examine will proceed.
Operator
Thanks. And our subsequent query coming from Mayank Mamtani with B. Riley Securities. Your line is now open.
Mayank Mamtani — B. RIley Monetary — Analyst
Good afternoon. Thanks for taking our questions, and congrats to Scott for a protracted listing of accomplishments. You may be missed. One big-picture query.
You have tended to focus as a corporation on prostate most cancers. Might we see a little bit of a method shift by way of as you get to this subsequent chapter for MacroGenics? And relatedly, should you’re in a position to give us a exact steerage, form of when — and if in any respect, subsequent yr, we might see each CRPC and perhaps lung cancer-specific knowledge for to evaluate direct comparability to each your program and the PRB 73 applications additionally attending to late-stage improvement? After which I’ve a follow-up.
Scott E. Koenig — President, Chief Govt Officer, and Director
Yeah. Thanks very a lot, once more, for the non-public feedback as nicely. With regard to the prostate most cancers, we’re an organization that’s strongly centered on creating a variety of remedies for strong tumors. We launched into prostate most cancers plenty of years in the past due to the alternatives there and the dearth of applicable remedies, notably for late-stage sufferers.
There definitely was a necessity there, and that clearly led to the event of a number of molecules which we’re pursuing. As you recognize, the B7-H3 applications in addition to lorigerlimab. And we’ll proceed with that. And I’ve mentioned the outcomes that we anticipate over the course of 2025.
With regard to 026, as we have talked about vobra duo. So, with 026, we’re taking a look at using this drug in numerous completely different tumor sorts. The dose escalation is open to a variety of B7-H3-positive tumors. The plan going ahead is to find out sufferers which have responses to 026 within the dose escalation now we have constructed into the Section 1 examine, the flexibility to do many expansions.
And so, because of this, with regard to responses in prostate for 026, we anticipate that we should always have knowledge in different tumor sorts as nicely. However at this level, once more, as I indicated, we’re solely in the course of dose escalation, and it is too early to find out what particular tumor sorts we’d pursue additional.
Mayank Mamtani — B. RIley Monetary — Analyst
Nice. After which one particular query relating to the TAMARACK learnings. The efficacy of VHD is usually comparable put up taxane. I used to be questioning if this might be due to B7-H3 expression and its maintained expression pre and put up tumor, which might be completely different than say, PSMA.
And is your expectation going ahead that is still the case as you propose to report the ultimate TAMARACK knowledge?
Scott E. Koenig — President, Chief Govt Officer, and Director
Yeah. So, we’re persevering with to have a look at, clearly, each the chemo-naive and the post-taxane settings for the TAMARACK knowledge. As we confirmed at ESMO and indicated, we’re having on the landmark time-frame of six months, we’re getting excellent responses in each the chemo-naive in addition to the chemo-experienced inhabitants. So, at this level, till now we have the ultimate knowledge, we’ve not assessed if we pursue this additional.
Once more, as I identified earlier, there are numerous issues that we’ll assess when now we have the ultimate knowledge. However proper now, it is nonetheless open to offering a doubtlessly new paradigm for therapy, each within the chemo-experienced in addition to the chemo-naive inhabitants. All comes right down to the diploma of exercise, the rPFS, in addition to the protection profile.
Mayank Mamtani — B. RIley Monetary — Analyst
Understood. And lastly, for the LORIKEET trial enrollment attending to completion right here, Scott. Can you touch upon how perhaps the affected person baseline traits, prior therapy publicity, VSM standing might examine relative to docetaxel trials which were accomplished in mCRPC beforehand? And will you simply make clear if the OS outcomes can even be accessible subsequent yr? Or would that take longer?
Scott E. Koenig — President, Chief Govt Officer, and Director
With regard to the traits of the LORIKEET, I’d say that the inhabitants for these chemo-naive sufferers was fairly much like what was enrolled within the sufferers for TAMARACK. So, they clearly had development on an androgen receptor concentrating on agent. And so, we expect that this will likely be a inhabitants that could be very attribute of what’s usually seen there for sufferers who’re on the usual routine would get docetaxel. The truth that now we have this as a managed trial, we can have our personal knowledge to see what docetaxel does alone within the 50 sufferers or so which might be handled with that agent alone as in comparison with historic knowledge.
So, I am feeling fairly assured that we’ll have a knowledge set that will likely be properly useful as in comparison with historic research. Now, with regard to general survival, I feel will probably be too early to have the ability to report that out in ’25. However provided that, as we stated, the examine will likely be fully enrolled by the tip of this yr or very early in ’25, I feel we’ll be in excellent form to current, clearly, responses, PSA reductions in addition to rPFS in ’25, however OS, perhaps slightly early.
Mayank Mamtani — B. RIley Monetary — Analyst
Thanks once more for taking the questions.
Operator
Thanks. And our subsequent query coming from the road of Peter Lawson with Barclays. Your line is now open.
Peter Lawson — Analyst
Nice. Thanks a lot. I suppose as we take into consideration your B7-H3 property, I suppose your second-generation molecule, how far behind is that when can we see the preliminary knowledge? And form of what do you need to see in that, I suppose, your first era B7-H3 to form of perceive if that and the way that strikes ahead?
Scott E. Koenig — President, Chief Govt Officer, and Director
Thanks very a lot, Peter. To remark, as you recognize, there are a variety of different molecules which might be shifting ahead. For topo 1 inhibitors, the info has been offered in plenty of completely different scientific varieties. Once more, we see most of the virtues of the way in which 026 was designed with regard to having a site-specific conjugation of the Synaffix exatecan with the DAR4 and with different profiles that even supposing we could also be behind in that exact molecule improvement as in comparison with others that we really feel that the chance right here is that this might carry out fairly nicely.
After which clearly, due to the broad expression of B7-H3 in several tumor sorts, the info that is been offered up to now for competing molecules has been in a restricted variety of tumor sorts. And so, regardless of the very fact there was knowledge that has been proven notably in small cell most cancers and in some circumstances, modest knowledge in different lung cancers, we really feel that we will be fairly aggressive with the 026 molecule as soon as we end dose escalation. And as I stated earlier, we anticipate that knowledge from the Section 1 examine to be accessible in ’25. With regard to the vobra duo molecule, once more, it is simply too early to spell out the chance right here.
Clearly, now we have the biggest knowledge set in prostate most cancers with vobra duo, however we should assess once more what is critical to realize a go-forward plan primarily based on the ultimate rPFS knowledge in addition to the ultimate security profile and whether or not additional tweaking will likely be mandatory for the dosing to maneuver ahead right into a prostate indication. So, keep tuned. We’re nonetheless very inspired by the prospects of each of our B7-H3 ADC molecules.
Peter Lawson — Analyst
Nice. Thanks a lot, Scott. And Scott, it is all the time been a pleasure speaking to you over the yr. So, thanks for all these conversations.
Scott E. Koenig — President, Chief Govt Officer, and Director
Thanks very a lot. And similar right here. I’ve had the identical feeling.
Operator
Thanks. [Operator instructions] Our subsequent query coming from the road of Stephen Willey with Stifel. Your line is now open.
Stephen Willey — Analyst
Yeah, good afternoon. Thanks for taking the questions. First, I simply needed to say better of luck to you, Scott. I’ve definitely loved all of the interactions over time.
After which second, only a fast query on MGC028. Simply curious as as to whether or not the Section 1 dose escalation program goes to be prespecifying for particular tumor sorts. If I keep in mind accurately, I feel ImmunoGen had outlined just a few completely different tumor sorts that it was excited by because it ran that Section 1 improvement program. I do know that you simply had been a associate with them, clearly.
However simply questioning if that listing of tumor sorts has modified, simply given that you’ve got stopped the payload out, there’s clearly an inherent sensitivity of various tumors to completely different payloads. And could be curious should you might simply give some data as to what tumors you are fascinated by. Thanks.
Scott E. Koenig — President, Chief Govt Officer, and Director
Yeah. Thanks, Steve. And once more, an actual pleasure, all the time working with you over time. The reply is sure, we’re going to restrict the particular tumor sorts going ahead.
As you recognize, specifically, this — primarily based on our personal preclinical knowledge in addition to IHC knowledge, we have proven overexpression in plenty of tumor sorts. So, one among the many tumors that you could possibly anticipate could be clearly lung most cancers and pancreatic most cancers, and at the least one other tumor sort as nicely. So, we really feel that that may give us one of the best sense as we dose escalate to have the ability to see exercise alerts in addition to clearly the protection profile of the drug. As you recognize, one of many challenges on the ImmunoGen molecule is that we had been by no means in a position to obtain the focused dose due to the excessive toxicity that was noticed.
Stephen Willey — Analyst
All proper. Thanks for the query.
Operator
Thanks. And presently, I see no additional questions within the Q&A queue. I’ll now flip the decision again over to Dr. Koenig for any closing remarks.
Scott E. Koenig — President, Chief Govt Officer, and Director
Nicely, once more, thanks, everybody, to your sort remarks personally. And clearly, we sit up for offering updates on our thrilling applications and different company-related exercise on our subsequent earnings name. And exit and vote if you have not accomplished it already.
James Karrels — Senior Vice President, Chief Monetary Officer, and Secretary
Good evening, everybody.
Operator
[Operator signoff]
Period: 0 minutes
Name contributors:
James Karrels — Senior Vice President, Chief Monetary Officer, and Secretary
Scott E. Koenig — President, Chief Govt Officer, and Director
Jim Karrels — Senior Vice President, Chief Monetary Officer, and Secretary
Scott Koenig — President, Chief Govt Officer, and Director
Unknown speaker — — Analyst
Jonathan Chang — Leerink Companions — Analyst
Etzer Darout — BMO Capital Markets — Analyst
Jon Miller — Analyst
Silvan Tuerkcan — Analyst
Mayank Mamtani — B. RIley Monetary — Analyst
Peter Lawson — Analyst
Stephen Willey — Analyst
