I-Mab at H.C. Wainwright Conference: Strategic U.S. Shift and Jeva Stomach Focus

On Wednesday, 10 September 2025, I-Mab Biopharma (NASDAQ:IMAB) presented at the H.C. Wainwright 27th Annual Global Investment Conference. The company outlined its strategic pivot towards U.S. operations and detailed the promising progress of its lead asset, Jeva Stomach, a Claudin 18.2 therapeutic. While the company highlighted financial stability, with cash reserves ensuring operations through Q4 2028, it also addressed challenges in a competitive landscape.

Key Takeaways

• I-Mab is focusing on U.S. operations and developing Jeva Stomach for gastric cancer.
• The company has $227 million in cash, ensuring financial stability through 2028.
• Jeva Stomach shows a high objective response rate and favorable toxicity profile.
• A phase two study is set to begin in Q1 2026, with results expected in 2027.
• Expansion plans include trials for biliary tract and pancreatic cancer.

Financial Results

• Cash reserves stand at $227 million.
• Financial runway is secured through Q4 2028.

Operational Updates

• Jeva Stomach is being developed for front-line metastatic gastric cancer.
• Phase one dose expansion study is fully enrolled; data to be presented in Q1 2026.
• A 180-patient randomized phase two study will start in Q1 2026.
• Expansion into biliary tract and pancreatic cancer is underway.

Future Outlook

• A randomized phase two study for Jeva Stomach will start by Q1 2026.
• The study aims to address unmet needs in gastric and other cancers.
• Results from the phase two study are anticipated in 2027.

Q&A Highlights

• Jeva Stomach competes with Claudin 18.2 assets like Zolbetuximab.
• Jeva Stomach has a lower expression threshold, doubling eligible patients.
• Competitive landscape includes antibody-drug conjugates and T cell engagers.

For further details, please refer to the full transcript below.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Li Chen, Equity Research Associate, CWA: Great. Thank you very much for joining at CWA 27th Annual Global Investment Conference. My name is Li Chen. I’m an Equity Research Associate. Our next company is I-Mab Biopharma. Joining us today is Phillip Dennis, CMO, and Joseph Skelton, CFO of I-Mab Biopharma. This is a clinical-stage biotech developing precision immuno-oncology therapies. Please go ahead.

Joseph Skelton, CFO, I-Mab Biopharma: Thanks, Li. It’s a pleasure to be here, everybody. I’m Joseph Skelton. I’m the Chief Financial Officer of I-Mab. I’ll give you a brief overview of the company, and then I’ll hand it over to my colleague Phillip Dennis, our CMO, to tell you more about our lead asset, Jeva Stomach. I-Mab is really a new old story. We were a global biotech company with China operations. We’ve since divested those operations to focus solely on the U.S. We now have three clinical-stage assets that we’re moving forward: Jeva Stomach, Raja Stomach, and Uli Ledla Mab. We recently announced some very exciting additional investment in Jeva, expanding our programs and also plans to initiate a randomized phase two by Q1 2026 in front-line metastatic gastric cancers, combining with I/O and chemotherapy.

The company is well financed with $227 million of cash on the balance sheet, which will provide us runway through Q4 of 2028. I will turn it over to Dennis to walk you through the pipeline.

Phillip Dennis, CMO, I-Mab Biopharma: Thanks, Joe. I really want to stay on this slide for a minute because this, as Joe mentioned, reflects not only our ongoing program but our future development plans. Our lead asset is Jeva Stomach, which is arguably a best-in-class, Claudin 18.2 therapeutic that we’re developing initially in front-line metastatic gastric cancer. We have two other assets shown at the bottom that we won’t have time to discuss today, Raja Stomach and Uli Ledla Mab. To focus on Jeva, the first thing that we want to talk about, and I’ll go over in a second, is our ongoing phase one study combining Jeva Stomach with the standard of care of I/O plus chemo in front-line metastatic gastric cancer.

This is a dose expansion study that has completed recruitment and will read out internally at the end of the year, and we’ll be able to present this data publicly in Q1 of next year. Importantly, through our recent investment, we’ve been able to announce that we will launch a scientifically robust, rigorous, large randomized phase two study that will have FPI in Q1 of next year. We have other programs that will really enhance the development of Jeva Stomach. This includes both an unmet medical need in gastric cancer, which includes the fact that patients are either treated with a checkpoint inhibitor plus chemotherapy or, for example, the targeted therapy such as Zolbetuximab, which is a Claudin 18.2 monoclonal antibody plus chemotherapy. Each of those targeted therapies, if you will, has requirements for expression of their target.

In a situation where there’s low PD-L1, where patients don’t qualify for a checkpoint inhibitor, or low Claudin that don’t qualify for Zolbetuximab, there’s a high unmet medical need because those patients are treated with chemotherapy alone. We are testing a cohort in our phase one study, testing Jeva Stomach in combination with chemotherapy alone. Finally, the success that I will tell you about in just a few minutes in our phase one study, dose escalation, dose expansion, has really prompted further development in other stages of gastric cancer, namely locally advanced resectable gastric cancer, where the standard of care is now evolving before our eyes since ASCO, where the Matterhorn data from AstraZeneca showed the addition of I/O to chemotherapy in resectable gastric cancer will become the standard of care.

One of the leading GI oncologists in the globe, Kohei Shitara in Japan, is very interested in testing Jeva Stomach in combination with I/O plus chemotherapy in locally resectable disease. We’re very excited to have his enthusiasm and involvement in our program. At the bottom of the Jeva Stomach section on the slide, you can see our expansion into other tumor types. Why are we doing this? Because Claudin 18.2 is expressed predominantly in three malignancies: gastric cancer, biliary tract cancer or cholangiocarcinoma, and pancreatic cancer. In our phase one study, we are actually doing cohorts where we’re adding Jeva Stomach to the front-line standard of care in BTC, as well as front-line pancreatic cancer. Finally, at the bottom, we have involvement of another leading GI oncologist, Jeremy Kratz, University of Wisconsin, who will be doing an investigator-initiated study combining Jeva with chemotherapy in resectable pancreatic cancer.

I’m very happy to say that this is a really tremendous portfolio and a really important set of studies that will generate data within our runway, which now extends to the end of 2028. I’m going to cover this slide very quickly. As you can see, Jeva Stomach is a potential best-in-class Claudin 18.2 therapeutic. We showed it as monotherapy. We have a clinically active asset with an ORR of 18%, incredibly well tolerated. There was no dose-limiting toxicity. A maximum tolerated dose was not reached in our phase one. In fact, a pristine profile in terms of full 1BB, in terms of no liver toxicity. In terms of gastric cancer, why gastric?

I mentioned to you part of this is driven by the expression of the biomarker, but the other is the high unmet medical need where, in fact, it’s the fifth most common cancer, yet it’s a horribly mortal cancer where the five-year survival is less than 10%. Nonetheless, this represents approximately a $12 billion market opportunity. The data on the right are meant there to put in your mind the benchmarks that currently exist for phase three studies in front-line metastatic gastric cancer. Nivolumab, one of the checkpoint inhibitors approved in front-line metastatic gastric cancer, approved in chemotherapy such as FOLFOX, led to an improvement of ORR of 10% with an ORR of 47% and a median PFS shown at the bottom left of those bar graphs of 7.7 months. Spotlight was a phase three study that led to the approval of Zolbetuximab. The ORR with Zolbetuximab is 40%.

The median PFS is 10.6 months, but I’ll point out to you, look at the control arm, FOLFOX. FOLFOX seemed to overperform in this study because if you compare FOLFOX and CheckMate 649, which is a much larger study of 1,500 patients compared to Spotlight, I think most people expect the performance of the chemo only arm to be around seven months. Nonetheless, those are the figures to benchmark our data. Next slide, please. The first thing I want to mention is Zolbetuximab is the leading asset in the class. However, its label is very restricted. Its label is restricted to 75% in tumors that express Claudin 18.2. 75% of cells have to express Claudin 18.2 at an intensity as assessed by immunohistochemistry of 2 plus or greater. This bar graph diagram was from Astellas, the maker and developer of Zolbetuximab.

The shaded area in the blue on the far right represents the patients that will qualify for Zolbetuximab based on the Claudin expression alone. That is about 40% of all patients. In our clinical development program with Jeva Stomach, in monotherapy, in combination, and other tumor types, our threshold is the lowest possible, which is 1% of cells, 1 plus or greater. If you total up all those bars to the left of the blue area, we, in essence, double the patients that are eligible to get our drug, Jeva Stomach, versus those that are eligible to get Zolbetuximab. Next slide, please. If you focus on the milestones, I’ll point out some really important ones for us. In just a matter of a few weeks, we’ll be presenting a phase one update of our monotherapy phase one data at the triple meeting in Boston.

Again, our objective response rate is now 18%. We’ve updated our tox data. Again, it’s a very clean tox profile, but we also have important biomarker data. In Q1 of next year, as I mentioned, we will be presenting our dose expansion data from a phase one study combining Jeva Stomach with Nivolumab plus FOLFOX. Early next year, we will also have our first patient enrolled in our phase two study. We had a press release this week that showed that it’s going to be a 180-patient randomized phase two study with PFS as our primary endpoint, and that PFS readout will occur again in 2027 while within our runway. Next slide, please. Jeva Stomach is a bispecific antibody. It has three important parts. Maybe we can go to the next slide. Thank you. This is highlighted on the right.

I’m going to go over this in a little bit of detail because the 18.2 class is crowded and people always want to know where does Jeva stand in terms of other antibody-based approaches, et cetera. The first thing I want to say is we have a very avid binding to Claudin 18.2. The KD for Jeva Stomach is tenfold lower. We’re turning it around. The binding of Jeva to 18.2 is tenfold higher than that of Zolbetuximab, so highly avid binding. The second structural component that’s important about Jeva is the FC portion shown in the middle. We’ve mutated that FC effector function, and by doing so, we eliminate processes such as ADCC and CDC. Why is that important? That’s how Zolbetuximab works, and Zolbetuximab is also associated with very high rates of nausea and vomiting.

Because we’ve silenced this function and because of the avidity of Jeva for Claudin 18.2, we have virtually, we have no high-grade nausea and vomiting. It’s a really nice profile for Jeva. Finally, at the far end of the molecule at the bottom, we have SCFE fragments that interact with full 1BB to activate T cells only in the microenvironment, and that’s shown on the left. If Jeva Stomach, because its FC effector function is mutated on the far left, if Jeva finds a circulating T cell, it doesn’t lead to activation of that T cell because the FC effector function is mutated and there’s no Claudin 18.2 present to lead to clustering of full 1BB. Clustering of full 1BB is required for that co-stimulatory signal to be propagated. On the right side of that diagram, you see a tumor cell at the top expressing an MHC peptide.

The T cell receptor 18.2 is expressed. There, molecules of Jeva combine to 18.2. They can, and then the SCFE fragments combine to full 1BB on a neighboring T cell, leading to clustering and activation. Next slide, please. This slide is meant to show how Jeva Stomach fits into the crowded 18.2 space. Jeva is shown at the top. Zolbetuximab is shown at the bottom. Again, Zolbetuximab works by ADCC, ADCP, and CDC. There are two other asset classes that I think are very important in the field. One are the T cell engagers that’s really epitomized by, in events, IBI389. As you’ll see in a second, this CD3 activating T cell engager has a high risk of cytokine release syndrome, which we do not have. We have no CRS. The other class of agents are antibody-drug conjugates. The lead one arguably is AZD0901.

There you have the usual panoply of bone marrow toxicities, et cetera, that we’ll show in the next slide, please. Sorry. We’ll start with the Zolbetuximab comparison, which really shows that, in fact, if we look at Jeva Stomach shown in the column on the left compared to Zolbetuximab early in its development in phase one and phase two studies, I’ll draw your attention to the top row. You can see that our eligibility criterion is 1% of cells, 1 plus or greater. In that scenario, our updated ORR shown down below is 18%. If you go over to Zolbetuximab with the same cutoff, they had a 0% ORR. When they tightened the threshold of 50% of cells being 2 plus or greater, they only had an ORR of 9%.

If you look across trials and look at the toxicity profile again, we had far lower rates of nausea and vomiting than Zolbetuximab. Next slide, please. This puts, again, Jeva, Zolbetuximab, the lead ADC, arguably, and the lead T cell engager side by side. I’ll point out first the threshold for Claudin 18.2 expression. Ours is the lowest at 1%. You can see the others do vary in their cutoffs. Moreover, if you go one down to the ORR, 18% seems to be better than Zolbetuximab, even when the threshold is higher, but it is not as good as the ADC or T cell engager. This, to me, and given the fact that these agents are being developed in second-line gastric cancer, not front-line, this, to me, seems a perfectly suited development path for these assets because they’re much more toxic. That is shown in the red box.

If you focus on treatment-related adverse events and you start on the left with Jeva Stomach, what I worry about as an oncologist is always grade three or greater because those are serious. Those are things that you need to address. They’re really one grade away from hospitalization and serious, serious outcomes. We have a 33% rate of grade three and above TRAEs. This, again, is from monotherapy. I want to emphasize that. If we look across that box to the ADC and T cell engager, you can see that the rate of grade three TRAEs is almost double. It’s almost 60%. What does that say? I think that reinforces the development plan of the ADC and T cell engagers to be developed in second-line and beyond.

It says to us, if you have to pick one of these agents to be tested in front-line gastric cancer as an add-on, Jeva Stomach is a perfect fit for that. That’s what’s really being borne out. Next slide, please. We did this study. It’s in all at U.S. sites, all at U.S. patients, six sites. What we did was test three different dose levels of Jeva Stomach added to standard of care Nivolumab FOLFOX, standard dose schedule. We’ve presented the data on the NF-17 at ESMO GI in early July. We have now completed dose expansion shown on the right. That’s the data that will be presented in Q1 of next year. Next slide, please.

Joseph Skelton, CFO, I-Mab Biopharma: Could you just briefly comment on the enrollment rate study?

Phillip Dennis, CMO, I-Mab Biopharma: Yeah, we have full in. One thing that’s really notable to us, again, six sites, we recruited months ahead of time. When you break it down by numbers, historically, the recruitment rate of gastric cancer patients in the U.S. is 0.1 patients per site per month. We’re recruiting at a rate above 0.8. We’re recruiting eightfold faster than historical norms for gastric cancer trials. That tells you about the enthusiasm of investigators in this drug. This is evidenced by the fact we have two leading investigators in GI malignancies wanting to work with Jeva, wanting to propose new studies. Next slide, please. In the interest of time, I’ll simply say the demographics are very typical for our phase one dose escalation portion for metastatic gastric cancer patients. This is the efficacy data. As shown by the waterfall, every patient had a response in their target lesion.

We had an ORR of 71% across the whole cohort and 83% in the two doses in which we are dose expanding. I’ll draw your attention back to the data with the phase three studies where the ORR with Nivolumab chemo was 47%. With Zolbetuximab chemo was 40%. These numbers far exceed those numbers. Moreover, below the numbers, you can see numbers. Those numbers are PD-L1 and Claudin 18.2 expression. The red numbers indicate low levels of expression for each of those biomarkers. On the right, you see the breakdown by ORR based on PD-L1 cutoff of either 5% and 1% and Claudin at 75%. I’ll simply say in the interest of time that we see profound activity both above and below each of these thresholds for PD-L1 and Claudin 18.2, again with the benchmarks being 47% and 40%.

The other thing I’ll point out in the far lower right is that I mentioned to you we’re doing a cohort now of these double lows, patients whose tumors don’t express PD-L1 or Claudin 18.2. In this very small data set where we have four patients, three of the four had a confirmed response. All these responses are confirmed. Next slide, please. It’s not only the fact that the high percent of patients respond, it’s also the fact that the nature of the response. These patients respond rapidly, as shown by the first set of dots to the right on the x-axis. You can see that everything goes down. If you follow those patients out over time, those responses deepen. Moreover, if you follow the patients out again beyond 300 days, we can see we now have three patients out beyond a year.

Responses are rapid, they deepen over time, and they’re durable. Next slide, please. This is a swimmer’s plot showing again the disposition for each patient. The median follow-up at the time of this data presentation was nine months. We and everyone else want to see median PFS data. We haven’t, frankly, had enough events to really talk about PFS. What we can do is estimate and calculate the predictive feature of whether or not patients will be progression-free at six months. When we did that for the entire cohort, it was 73%. The two dose levels bringing forward in dose expansion, it’s 82%. If you go back to those phase three studies, look at the Kaplan-Meier curve for PFS. Those numbers at six months look quite favorable compared to those phase three studies. Next slide, please. This is meant to, the other half of development is toxicity.

Jeva is incredibly well tolerated. The tox profile looks very much like CheckMate 649, the Nivolumab plus chemo standard of care. The green boxes on the right, nausea and vomiting are highly associated with Zolbetuximab, where they have almost a 20% incidence of grade three and above. We have zero. If you look at AST and ALT, this has plagued full 1BB asset development. We have one patient that had grade three and above transaminase elevation. Next slide, please.

Li Chen, Equity Research Associate, CWA: In the interest of time, can we jump to the phase two that we recently announced?

Phillip Dennis, CMO, I-Mab Biopharma: Yes, sure. This is a phase three that we are embarking upon. This is a randomized study, 180 patients. We are testing two doses of Jeva Stomach at 8 and 12. These are the dose levels being expanded. We do anticipate that as this study gets going, we’ll be able to probably drop one of these doses after review with the FDA and have a two-arm study, with 180 patients expected in this study. Next slide, please. This is meant to show, in fact, that there’s so much white space that is here depicted as purple and blue, where Jeva is potentially first-in-class or best-in-class in front-line metastatic gastric cancer. Next slide, please. Here it simply shows that these are the other opportunities that we’re starting to investigate in pancreatic and cholangio or biliary tract cancer with market opportunities of $6 billion and $3 billion, respectively. We’re very excited.

Next slide, please. We have good intellectual property protection. The final slide is, again, I want to point out the fact that this is a potential best-in-class therapeutic. We have a very high objective response rate. We have emerging PFS data. The responses themselves are rapid. They deepen, and they’re durable. We’ve had patients with low levels of PD-L1, as well as Claudin 18.2, that have responded. We’re testing this now by launching a very large randomized phase two study. We see Jeva as having very, very broad potential in both other stages of gastric cancer, as well as other solid tumors. Thank you.

Operator: Great. Thank you for the presentation. Any questions from the audience? If no, we’ll close.

Phillip Dennis, CMO, I-Mab Biopharma: Pardon me? Competition, yes. There are several Claudin 18.2 assets being developed in gastric cancer. Zolbetuximab is arguably the leading one. Zolbetuximab, it’s an antibody made by Astellas that has an indication now in chemo alone, not with I/O chemo. I/O chemo is used in 80% to 90% of all gastric cancer patients. The other competition, as I mentioned, were antibody-drug conjugates and T cell engagers that work through CD3, typically.

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