IMAB at Jefferies Global Healthcare Conference: Promising Pipeline Developments

On Thursday, 05 June 2025, IMAB (NASDAQ:IMAB) presented at the Jefferies Global Healthcare Conference 2025, revealing strategic insights into its clinical pipeline. The company highlighted both promising advancements and ongoing challenges, notably in its Claudin 18.2 bispecific antibody, Giva (FT825), aimed at addressing unmet needs in gastric cancer treatment.

Key Takeaways

• IMAB is financially robust with $168.8 million to support clinical developments.
• Giva (FT825) shows promise in frontline gastric cancer therapy, with an upcoming data release at ESMO GI on July 2nd.
• The company plans further data releases for Raji and Yuli in late 2025 and early 2026.
• IMAB’s team highlighted Giva’s unique features, including high binding affinity and reduced toxicity.

Financial Results

• IMAB holds $168.8 million, ensuring funding through key clinical readouts.
• The Claudin 18.2 positive gastric cancer market is valued at $12 billion, a target for Giva’s application.

Operational Updates

• IMAB employs 25 staff, focusing on clinical efficiency within the US.
• Giva’s dose expansion is progressing rapidly, with data to be presented at ESMO GI.
• Raji’s Phase I study aims to optimize dosing to minimize liver toxicity.
• Yuli’s Phase 2 study in lung cancer is underway, with results expected soon.

Future Outlook

• Giva’s expansion data is anticipated in early 2026, with ongoing monitoring for progression-free survival.
• Raji’s therapeutic window study results are expected by the end of 2025 or early 2026.
• Yuli’s study results, crucial for future development, are due in the second half of 2025.

Q&A Highlights

• Giva’s differentiation lies in its high binding affinity and engineered Fc region, reducing systemic immune responses.
• The therapy is compatible with standard chemoimmunotherapy, showing strong response rates even in low-expression tumors.
• Raji’s study focuses on adjusting dosing to reduce liver toxicity while maintaining efficacy.
• Yuli’s development hinges on upcoming study results, potentially validating patient selection based on CD73 expression.

In conclusion, IMAB’s presentation at the Jefferies Global Healthcare Conference 2025 underscored its strategic focus on advancing its clinical pipeline. For more detailed insights, readers are encouraged to refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Yifan Shi, Jefferies Biotech Research Team, Jefferies: Great. I think we can get started. Good afternoon, everyone. Thank you for attending Jefferies Healthcare Conference. My name is Yifan Shi from Jefferies Biotech Research Team.

Today, we are very pleased to have Doctor. Sheng Fu, CEO of IMAP, and Doctor. Philip Dennis, CMO of IMAP, in for this session. Welcome.

Sheng Fu, CEO, IMAP: Thank you.

Yifan Shi, Jefferies Biotech Research Team, Jefferies: So, to get start, so for those who may be less familiar with your story, could you please provide a high level overview of your company and your differentiate differentiated pipeline?

Sheng Fu, CEO, IMAP: Absolutely. Thanks, Ivan. Can you guys hear okay? Mic calling? Okay.

It’s great, great opportunity here to share the I Mab story. I would say that when you think about the I Mab, it’s a company with long history, really it’s a new company, reborn through recent strategic changes. We had a divestiture last year separating out assets from China from The S. Company, which is the list go on NASDAQ now is really focused on clinical development, really focused being a U.

S.-based biotech company and really focused on efficiency. We have 25 employees all in U. S. And so we are, U. S.

Based company. And out of our pipeline right here, I would highlight a few of those and Philip can give you more details. The most exciting one, I think it is the one that is a clouding 18.2 for one bb bispecific antibody that we’re developing as a bolt on to the frontline gastric cancer to bolt on to the standard of care, in this case is IO and chemo. And this agent is active in monotherapy studies and showed a very good profile in terms of safety as well as in combination as well as efficacy, when added to IO chemo. And I’m happy to say that we are only weeks away from disclosing our escalation study data at ESMO GI on July 2.

This is a major data release of the company talking about the history of the company. I think this is an exciting milestone for us. Many of you may not, think of gastric cancer, in the light of being a significant disease in a large market like lung cancer or breast cancer. But it turns out there is significant unmet medical needs. Globally, every year we have about a million people diagnosed with, gastric cancer and six hundred thousand of those eventually died.

And the five year, survival is dismal in seven percentage. So there’s a significant unmet medical need. And that translates to significant commercial opportunities. If look at the first line, clouding positive addressable market size is 12,000,000,000 and Jeeva is positioned strongly to compete for that $12,000,000,000 opportunities. And finally, would say, IMAB is in a very fortunate position that we have $168,800,000 on balance sheet.

So that will fund us through some of the clinical readouts. For example, the escalation study that we’re going to report at ESMO GI as well as the expansion study that we’re actively conducting right now. By the way, we’re ahead of the schedule. We’re very excited about that. And we’re going to share the expansion study first half of next year.

So some of those studies will really drive additional growth for the company. And we’re fortunate to have the resources to do that.

Yifan Shi, Jefferies Biotech Research Team, Jefferies: Great. So, now, let’s dive a little deeper into Jiva. So, as you mentioned, Jiva has shown very compelling monotherapy data in both efficacy and safety. Could you please walk us through the Phase I monotherapy data and what findings are you most excited about?

Sheng Fu, CEO, IMAP: I’ll invite Philip to give you the details.

Philip Dennis, CMO, IMAP: So I think the excitement on Giva is I want to take a step back is related not only to the clinical data that I’ll describe in a second, but also its molecular design and features of it as a molecule. Namely, it has very high avid binding in claudin 18.2, about a log more avid than the leading acid in the class, obetuximab. If we look at the middle part of the molecule, the Fc interacting portion, that’s been mutated. We’ve engineered out processes such as ADCC and CDC that can be associated with on target toxicity, again demonstrated by the lead acid in the class of obetuximab. And finally, the four-1BB interacting domains are SCFE moieties and they only interact with four-1BB in the presence of claudin 18.2, in the presence of a tumor cell expressing claudin 18.2.

What that translates to is that if our bispecific encounters a T cell in circulation, it doesn’t stimulate it. So we’re actually seeing very little systemic immune responses. We’re not seeing liver toxicity the way many four-1BB molecules have been played out the clinic. So there’s some molecular features that are distinctive. Our phase one study was notable for the fact that in a group of heavily pretreated gastric cancer patients, forty five patients now, and patients who had received the median prior three prior lines of therapy, we had a confirmed objective response rate of eighteen percent.

And notably, almost all of those patients had received prior IO. If you look at the toxicity profile, the grade three and above treatment related adverse events were in the single digit, typically one patient out of forty five. So this is an incredibly well tolerated monotherapy. And when we looked at the development opportunities for Giva, we hypothesized that other claudine eighteen point two assets like ADCs or T cell engagers that more bluntly activate T cells through CD3 probably have a role to play in later lines of therapy, but they’re going to be difficult to combine with the frontline standard of care. And Jeeva, based on its phase one data, monotherapy data, really suggested that it was perfectly suited to be combined with the standard of care of immuno chemotherapy.

And that’s what we’ve done.

Yifan Shi, Jefferies Biotech Research Team, Jefferies: So on this very favorable safety profile, probably could you please provide like more context? Does this drug has like lower dose reduction and the lower dose discontinuation rate? And do you believe this very favorable safety profile could help translate tumor responses rate into more durable clinical response like PFS and OS in the first line?

Philip Dennis, CMO, IMAP: So we have very low rates of discontinuation or treatment interruptions in the monotherapy data. And I will mention parenthetically that a peer reviewed paper describing the monotherapy data has been accepted for publication in clinical cancer research. So I encourage you to look there. This is data that I think will be very helpful and explain a lot of the field. So the monotherapy data suggests that we didn’t need to interrupt, we didn’t need to discontinue patients.

Again, if you look across the board, there are low grade AEs. There’s no reason to, again, interrupt or discontinue. And what that means is that patients should be able to stay on study, on treatment, in combination with frontline. And what, again, we’re very encouraged by I want to emphasize this the oral presentation at ESMO GI. This will be an oral with review by an independent discussant.

So we’re very excited to get that independent perspective as well. That what you’ll see is that in combination with nivolumab and FOLFOX, the toxicity profile looks very similar to that of nivolumab and fulphoxolone. Very similar to what was described in CheckMate six forty nine that led to the approval of nivolumab in that setting.

Yifan Shi, Jefferies Biotech Research Team, Jefferies: Yeah. We are certainly really looking forward to the data presentation next month, I think, at ASCO ESMO GI, right? July 2. Yeah. Probably, could you take this opportunity to help, like, investors set some expectation and probably like what special data point, like either efficacy or safety, that we should pay special attention to?

So this is

Philip Dennis, CMO, IMAP: the first to Sean’s point. I think we’ve been talking about presenting data certainly as long as I’ve been with the company. And this is the first volley and a long volley of data presentations at ESMO GI. ESMO GI is focused on 17 patients that were in the dose escalation port, part of our phase one dose escalation of Giva in combination with nivolumab and FOLFOX. Standard of care, nivolumab and FOLFOX, we don’t modify the dose or the schedule.

It’s a bolt on strategy. You will see two things. One I just alluded to which is the tolerability. This is a very well tolerated regimen with a toxicity profile that looks like nivolumab and FOLFOX alone. The efficacy is quite interesting.

We have an extraordinarily high objective response rate if you compare it cross trial for all those weaknesses that we can imagine and know about. A small study in phase one versus a phase three, but our objective response rate is far above that that was observed in either CheckMate six forty nine that led to the approval of nivolumab or Spotlight that led to the approval of zolvetuximab in combination with chemotherapy. So we have a really impressive objective response rate. But more importantly, there are anecdotes. There are patients in this study that I’ll refer to as double negatives.

What do I mean by that? I mean these are patients that have PD L1 less than one percent. These are patients that have low claudin. And in this small group of patients, it’s a small group within a small study, we’re actually seeing responders. And those patients would not be expected to respond to either nivolumab chemo alone or zolvetuximab chemo alone.

So we’re seeing pockets and subgroups of activity that I think are exciting. So that’s, it’s a bit early for PFS. We do make an effort to show some PFS. We have follow-up of almost a year. So we’ll present this data in detail in terms of the numbers.

And but the PFS is still early. The patients are all, you know, most of them are still on study. We’ve got very few events. But it’s all very encouraging. And to Sean’s point, as we speak, we’re continuing to complete enrollment in the dose expansion cohorts, the two highest doses that will be presented in July, so that we can gain more knowledge in those subgroups, validate the results that we’re seeing in escalation.

Yifan Shi, Jefferies Biotech Research Team, Jefferies: Super excited. And for the patient population with low Cloudy 18.2 expression, we also noticed that during the monotherapy trial, you also show very encouraging data in this patient population with low clouding 18.2 expression. Probably, could you please elaborate on why GBA could differentiate from competitors in this specific population? And on the market opportunity perspective, what implications could this have for I mean, expanding the market opportunity for Jeeva?

Sheng Fu, CEO, IMAP: Yeah. Thanks for that. Philip can talk about the science of why it’s differentiated in terms of patient coverage. But I would just say that this is to the core of why we believe Jeeva is strongly differentiated from competitors. If you think about the clouding coverage, the only approved agent right now is zobetuximab requires patient to have 75% of the tumor cell have two plus three plus stain intensity.

And for our clinical trial, we are looking for patients with 1% of the tumor cells as one plus intensity. So that significantly expands the scope in terms of GBUS patient coverage. There is yet another dimension if you think about 18.2 landscape. ZOBI is approved to be combined with chemo and chemo only. No IO components.

Which means when patients have higher expression of PD L1, their standard of care will not be ZOBE chemo. They will be IO chemo. So in that space, Jeeva will add value by directly and simply combining with nivo and chemo. So when you take those two dimension constraint into consideration, Jeeva’s population coverage is an order of magnitude bigger than ZOBE, the first eighteen points to approve the access. So from that differentiated perspective, it is very strongly positioned at Giva to be competitive in this space.

And I’ll turn it over to Philip to talk about the science.

Philip Dennis, CMO, IMAP: Yeah, I’m going to well, I view the distribution as well as science, right? So just to put numbers on it, we actually double basically double the claudin positive patients that would qualify for Giva as opposed to zolbituximab. And because we’re seeing activity across the range of PD L1, again that’s because PD L1 above one percent is about eighty to ninety percent of gastric cancer patients. Those patients will be treated with an IO chemo backbone. So Zolbee chemo alone is going to be limited use in those patients that are PD L1 negative.

So it really is, we’re vastly expanding the patients that can benefit from Giva. The hypothesis for why Jeeva works in a low claudin setting and to reference the monotherapy study, we had a responder with a claudin level as low as eleven percent in the monotherapy study. I think it’s due to the properties that I alluded to earlier which is a very high affinity for claudin. So you don’t need that many tumor cells. And if you think about the Zolbe indication, it’s not only seventy five percent of the tumor cells, they have to express a lot of 18.2.

It’s two to three plus staining which is a surrogate for protein expression, right? So they have most of the tumor expressing a lot of 18.2. Our threshold is one percent of tumor cells at one plus or greater, so very faint or low protein expression. So I think part of this is due to the fact that the affinity is very high for claudin 18.2. And as I mentioned, the precise activation of T cells by the fact that you have 18.2 in a tumor cell that binds to the part of Giva that interacts with 18.2.

You have the four-1BB interacting moiety on the other end and that leads to clustering of four-1BB on the T cell surface and leads to activation of that T cell only because it’s in the tumor microenvironment.

Yifan Shi, Jefferies Biotech Research Team, Jefferies: Cool. So during the past week, during ASCO, we see several data drops from different modalities targeting Clouding eighteen point two, I think including probably like two ADC and one CAR T cell therapy even in a small number of patients. So probably like how do you feel about this data and on a more broadly perspective, like, compared to those emerging modalities, where do you see Jiva standing out most clearly? And like, how do you how would you like to take advantage of GWAS unique feature to moving forward?

Philip Dennis, CMO, IMAP: So as an oncologist who, again, spent twenty plus years taking care of patients, I’m excited for patients to have opportunities if their tumors express clotting 18.2 that they have options. And I think that for modalities like antibody drug conjugates, T cell engagers that really, again, bluntly and clearly activate T cells sometimes in the tumor, sometimes outside the tumor, I view ADCs and direct T cell engagers through CD3 as being very good candidates for later lines of therapy. In other words, they have a higher objective response rate than Giva, but they come laden with toxicities. Toxicities, for example, grade three and above treatment related adverse events as monotherapy, sixty percent. Sixty percent of patients will have.

And that’s more than really double what we see with Jeeva in combination, okay? So there is a sense that these I erred, I meant Jeeva and monotherapy. So these assets have a future in later lines of therapy. Jeeva is perfectly suited to be combined with, again, the standard of care because you add it on. ADCs, I think, are highly unlikely to move into simply adding them on because they’re too toxic.

You can’t take a regimen like nivolumab fulphox that has a grade three and above adverse event rate of fifty five percent and add another agent alone that has a fifty five percent incidence of adverse events without taking something away from that standard of care, because patients won’t tolerate it, right? So that’s the difference. We hypothesized, we’ve now shown, as everyone will see in July 2, that Giva can be combined. And although, again, if I’m sitting in big pharma and I have an ADC or a T cell engager, I am thinking about how to move it in the front line, but I am also very, very aware of the experience of other ADCs that you can’t take an ADC, move it into an immunochemotherapy regimen without taking something away from that regimen.

Yifan Shi, Jefferies Biotech Research Team, Jefferies: Super excited. Really looking forward to the front line data on July. Now, let’s move to another asset, PD L1, four-1BB, bispecific. Could you please, like, introduce this asset and probably the developmental timeline and the key catalyst for this drug?

Philip Dennis, CMO, IMAP: So Raju Stomach is our PD L1-41BB bispecific. It is being developed in collaboration with our partner ABL. It is constructed very similarly to Giva in the sense that the Fc moiety has been mutated, so there’s no ADCC or CDC. The four-1BB interacting part is very similar to Giva. But the other end where claudin eighteen point two is in Jeeva, that’s PD L1.

I can summarize our phase one data by saying in a cohort of we did multiple dose escalations in many different tumor types. And in a highly pretreated population, again, median number of prior therapies of three, as monotherapy we had an objective response rate of twenty seven percent. In these seven responders, five of which had received prior IO, and in fact one of the responders had a complete response that was a patient with ovarian cancer with seven prior lines of therapy. So we had, I think, the properties of something that had requisite efficacy for monotherapy. But when we looked, our line of sight for Raji has always been that we wanted to develop it in combination for IO refractory or resistant patients.

And when we looked at the rates of liver toxicity with Raji, we saw that the rates of grade three or above AST and ALT elevation signs of liver toxicity were in the twenty percent, twenty five percent range. And we felt this was prohibitive. So we have an asset that has activities monotherapy. It has probably higher than we would want liver toxicity. So we amended the phase one and we have new cohorts now recruiting in our phase one study where we’re decreasing the dose and or increasing the interval between cycles to allow T cells to recover.

Because what happens when you continually stimulate T cells with four-1BB, they can become exhausted. We saw no signs of this with Jeeva, but I think the liver toxicity said to us that we should take another look at this. And so we’re in the midst of doing this. We’re in the midst of recruiting the first set of patients. And I can tell you in the first set of patients, again modifying the dose and or schedule, we haven’t seen any grade three liver toxicity.

So we’re very excited that we’re going to be able to titrate the toxicity down, maintain the efficacy it’s very early for efficacy and be able to really be positioned well to combine with other modalities, other IO. And as this cohort plays out, we’ll also identify which tumor types appear to be the best to take forward in a phase II study.

Yifan Shi, Jefferies Biotech Research Team, Jefferies: Thank you. And for the post IO setting, where already showed the compelling data and during the past ASCO, we show several data drops in these settings such as PD L1 ADC and PD L1 IL-two bispecific. So how would you view these post IO setting would involve in the next few years and the potential market opportunity for IMAP?

Philip Dennis, CMO, IMAP: Yeah. Obviously, that’s the holy grail. As you know, I spent many years of my career in big pharma developing checkpoint inhibitors. And I will say that resistance to checkpoint inhibitors is the holy grail. So there is a lot of activity in this space.

I think the four-1BB approach is a really interesting one. I think there are many studies that suggest that either through a bispecific approach like the IL-two, the modified IL-two in combination with PD-one, that maintaining checkpoint blockade, a PD-one, PD L1 checkpoint blockade with a novel IO agent makes sense. So what we like is this single molecule does both, right, in a sense. But even if we wanted to maximize the checkpoint blockade, could combine it with a traditional checkpoint inhibitor. So I think we’re clearly in a competitive field in the IO progressors, refractory resistant.

But we think that, you know, we have a very nice nice objective response rate. We had good sustained responses in those patients. And if we addressed the liver toxicity issue, the rest of the toxicities were minimal. We have no CRS. We have no icons.

We have no serious immune related adverse events.

Yifan Shi, Jefferies Biotech Research Team, Jefferies: Great. Probably let’s spend a few minutes on the CD73 monoclonal antibody ULE. So you previously guided that the developmental path for this asset really depends on the ongoing China trial. So, maybe probably help us set expectations that what kind of efficacy and the safety data in the China trial would drive your decision to continue to develop this asset?

Philip Dennis, CMO, IMAP: So I think the development of Yulilevelumab or Yuli that’s being done in partnership with TJ Bio is this is a really important development period for Yuli. For the simple reason is that we’ve presented single arm data combining Yuli with a checkpoint inhibitor that suggested that if you select for patients that express CD73, it looks like you enriched the response for Yuli plus a checkpoint inhibitor. So the natural next step is to generate randomized prospective data. And that’s the critical study coming out of TJ Bio, which is a randomized prospective phase two study in front line non small cell lung cancer comparing Yuli plus checkpoint inhibitor versus checkpoint inhibitor alone in a CD73 positive population. So this study has completed recruitment.

The analysis, they’re waiting for events and we expect to have data available in the near future, in the next several months. So obviously if this data is positive, providing proof of concept that we can select patients based on CD73, this will be important information for us to consider as we consider further development of Euli.

Yifan Shi, Jefferies Biotech Research Team, Jefferies: Cool. So finally, can you lay out the company’s plan for the rest of 2025 and also 2026, like key milestones, catalysts, and that investors should pay attention to?

Sheng Fu, CEO, IMAP: Yeah, definitely. As you can tell from the Q and As up to this point, we got a few very exciting data flip coming in the near future. Most importantly, the Giva ESMO GI escalation data. This is the first combination data. And you will see the position of the Giva in a very competitive and hot area.

Last few days, we had the deal with Astellas, their license and ADC. That to us is a wonderful news because 18.2 now not only is a commercially validated target, people continue to believe the value of this target and continue to believe in the value here. And for us, that’s a great news. And the fact that the ADC, as Philip talked about, is primarily a good candidate for second line and third line is not really a direct competitor, that particular asset to us at this point. So we think we are positioned strongly in the frontline gastric cancer.

So asthma GI is one data flip. That’s very important. And then we’ll continue to monitor that escalation data that when the data matures, we’ll communicate the PFS from that data. Now you’ll also recall that we have expansion cohort for the two higher dose. And those two doses those two cohorts are recruiting ahead of the schedule, reflecting the enthusiasm that we have for our PIs.

This is an all America study. All study sites are in America and the major cancer centers, Memorial, Mass General. And the PIs look at the data they have experienced with monotherapy Giva, with escalation Giva and many of them also have experience with ZOBE. So when they have this side by side head to head comparison experience, in many cases, they put patients on our study, right? That’s why we can recruit ahead of the schedule.

And to me, that is underscoring the value and potential of a Jeeva in a professional setting. So that gave us opportunity coming back to your question is to continue to monitor data for the escalation, for the duration of the benefit. Then coming into 2026, first half of ’20 ’20 ’6, we continue to guide that expansion data readout. We will communicate first half of twenty twenty six. For the other assets, for Raji, was the therapeutic window optimization Phase I ongoing, we expected to get readout.

It is an adaptive clinical design. So it’s going to take a course until we get to the endpoint. But expectation is that we’re going to have a readout by end of the year and that we may communicate that results early next year. For Yuli, we are looking at a study that’s currently conducted by TJ Bio. We don’t have control of their timeline, but expectation is that second half of this year, we’ll be able to see their results and that will inform our decision going forward.

A lot of things going on. Very exciting time for I Mab and very much looking forward to sharing more data as they become available.

Yifan Shi, Jefferies Biotech Research Team, Jefferies: Great. We are right on time. Let’s wrap up the session here. Thank you again for joining us today and thank you for everyone to attend. Thank you.

Thanks.

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