Good afternoon, and welcome to day number two at our Cantor Fitzgerald Global Healthcare Conference. My name is Daniel Brander. I work here at the Biotech Equity Research. It is our pleasure to welcome NovaBridge Biosciences and CEO Srishti Gupta. Maybe just for our audience, Srishti, if you would not mind level setting what NovaBridge is about and what your vision is for the company.
Thank you, Daniel, and thank you everyone. NovaBridge is a global biotechnology company that really combines three things. One is access to innovation, the second is a clinical team that advances that innovation, and then the third is capital allocation with flexible pathways to move that innovation towards becoming a therapeutic for patients in the most appropriate way possible. We have a BD team that sits in China, and we are constantly looking across the Asia- Pac region and other places around the world to find really differentiated potential therapies.
Our clinical team sits in Rockville, Maryland, and they are advancing programs across phase I to III areas, and I would love to talk about a couple of our programs today. Then the third is, with our investor base, and our approach, we are really trying to use disciplined capital allocation to make sure that the function follows the asset's best pathway to becoming a therapeutic for a patient.
Great. I think you mentioned two programs that you are excited about that we can talk about today. I think people will most likely be most familiar with givastomig. Maybe we can start there with an intro of what you have shown to date and what kind of data updates and what cadence you are expecting.
Perfect. Thank you so much. givastomig is a bispecific. It's a Claudin 18.2 with a 4-1BB conditional activation, and we're advancing a program right now in first-line gastric cancer, although there's several other areas that we're also evaluating for givastomig. To date, we've initiated and we're advancing and we'll be sharing at ESMO our more mature dataset in our phase I-B study, as well as we have initiated and we have patients enrolled in a phase II study.
What makes me most excited about givastomig is that it has, in a very short period of time, moved from a phase I asset where in July 2025, we had 17 patients, and we shared the data at ESMO GI, and it is now with a phase III program that has been discussed with the FDA for an accelerated approval pathway with potential Fast Track designation and is moving forward for initiation of the trial by year-end 2026.
What we've seen with this, the data that we've shown, and we'll be updating the data at ESMO next month, is over the standard of care, improved ORR, and progression-free survival. O ver PD-1 and FOLFOX or CAPOX, depending, so immunochemotherapy. W e're very excited about the Claudin space because as zolbetuximab has shown as a monoclonal antibody, we've validated the 18.2 pathway in gastric cancer.
With givastomig, what we're really trying to do is do something that's a little bit broader because we have patients that can be down to low Claudin levels, which is not something we see with zolbetuximab. We have a very favorable safety profile compared to some of the other therapies that are in the space already and coming in the space. W e are on top of immunochemotherapy, so we see a very practical use in the settings.
And maybe for the ESMO update, what should we be expecting and looking for specifically at that update?
I think a couple things in the ESMO update, we have now advanced from about 17 patients at the last ESMO to now close to 70 patients. We'll see a more mature dataset across the doses that we were evaluating, both 8 mg/kg and 12 mg/kg for patients. C ontinued strong results on the ORR and the progression-free survival. We'll share that, but it's consistent with the very strong data we've shown, and we will share a little bit more on the safety profile that we're seeing across the doses.
W e will be actually excited to have a webcast post-ESMO, right immediately after ESMO, where we'll recap some of the ESMO data, but we're also very excited to be sharing a little bit about our phase III program and how we're designing that going forward. Stay tuned for that.
O kay, that's very exciting. Not to take away too much from the regulatory update in this context, but what gives you confidence that going from the initial 17 patients to now almost four times as many will hold up? Or where do you potentially see some nuances that investors should watch out for?
I t's a great question. I think as we have followed the data as it matures from the 17 patients, and the continued efficacy is definitely one thing that gives us the confidence on the phase III. The FDA's feedback is also another one. I think as we've been talking to our investigators, I think it's also very clear that the breadth and the unmet need for low Claudin 18.2 patients is real. F or us, it's not just inclusion criteria, right? It's really for us, where are the patients that we see the right risk-benefit? These are patients that we can identify with biomarker, and know that they will benefit from, as HER2- negative Claudin 18.2- positive patients, with a very targeted therapy with givastomig. T hen the other thing is for us, differentiation is multifold, right?
It's not necessarily just an efficacy number, it's not just one statistic, but the differentiation is really going to come down to when and how it gets to patients, and we see that'll happen at the clinic level, in the community settings. Being on top of immunochemotherapy, which is currently the standard of care, I think we have a very strong. With what we're signaling so far with the data from the phase I-B, good efficacy on top of now on the immunochemotherapy in combination. We really think that this is something that can start to become best in class for frontline gastric cancer.
Immunochemotherapy comes with its own set of adverse events and certain safety profile. You've described some You had an initial disclosure of your safety profile as well, and how do you think you will go forward in educating physicians and rollers ahead of your phase III trial about these AEs and how they may or may not be linked with efficacy signals?
It's a really good question. As we've been evaluating givastomig in combination with immunochemotherapy, I think what we did not see in monotherapy for either the PD-1 or for givastomig, we see that they're in combination. We see a treatment-related signal around increased activity in gastritis, which is very normal and very localized, and it's actually quite expected. We see it as sort of an efficacy potentially related signal. Because we've noticed it in combination, I think as we're looking forward to the phase III, I think it's just important for us to make sure that we are looking for it, physicians know about it, and they're able to manage it without discontinuation of therapy.
As we've gotten more sophisticated and are looking at the I-B patients and working with those sites, I think we've already seen a dramatic improvement in the number and the management of that particular treatment-related side effect. Outside of that, I think you'll see it as we come through. There's not many other side effects that we think are sort of outside of just backbone therapy. We see those in just immunochemotherapy. What's interesting to us is that we're also avoiding a lot of the more complicated side effects that we see with some of the potential new therapies.
I think ADCs, T-cell engagers, they come with a range of side effects that often not only push those therapies to being more second line and third line for gastric cancer, but on top of immunochemotherapy, that would be just a lot of side effects for physicians to manage with their patients. We don't really know how they would add on to immunochemotherapy. We think that we have the right balance between safety and efficacy and tolerability with patients with the current backbone, and we're very mindful around it, and we're designing the phase III to keep an eye on it and to design sort of into the management of it.
You just mentioned your differentiation goes beyond just the efficacy metrics, and I am hearing a little bit about combinability and the AE profile as well. T here is obviously also other indications and the Claudin expression levels that you have described. What other factors would you say givastomig can differentiate from zolbetuximab beyond the current indication?
Within gastric cancer, I think we are thinking about several different areas, and then we also have some thoughts on where we are going with our phase I studies beyond gastric cancer. W ithin the HER2 negative space, right now our registrational pathway is on PD-1 positive Claudin positive patients, and our Claudin levels are low. Because of the affinity of givastomig, we know that we can go down to Claudin 1 at CPS scored 1. Zolbetuximab, just as it is defined sort of the Claudin space, was at 75 and with a CPS score of 2+. A lready we are accessing patients that are not being accessed by the zolbetuximab in the standard. T hat range is probably doubling the number of patients that we could see potentially eligible for givastomig.
Beyond that, as we think about the patients, we could actually see other difficult-to-treat patients, which could be PD-1 negative patients. As we are designing the phase III, the screening criteria, companion studies, I think we would love to kind of make sure that we have the ability to help physicians offer patient solutions in that space. T hat is within the gastric cancer space. I think as we go beyond gastric cancer, we are looking at other potentially Claudin tumors.
W e have phase I-B enrolling for PDAC as well for pancreatic duct adenocarcinoma, as well as BTC biliary tract cancers. W e are also looking to see in 2027 how the phase I data bears out there. W e see this as a sort of a registration path with first-line gastric, but potential to expand both within gastric as well as in pancreatic and biliary tract.
Just let us know if you cannot comment on it quite yet, but is there a path to a potential accelerated approval in your phase III or possibly on-
Yeah, I think there's definitely a path towards accelerated approval. I think we'll see how the data bears out, and then we'd love to share a little bit more about that as we kind of get out of ESMO into our phase III study.
Very exciting. Sounds like ESMO's going to be a big deal. You touched on the potential for the patient population. It sounds like it's roughly double, and then how should we think about Claudin 18.2 levels in the other indications? Could it be similarly in size, or would it be a huge upside for you to develop it outside of frontline gastric?
Definitely, I think the potential in biliary tract and PDAC could almost double the market size for us outside of the gastric cancer. Very exciting. More important to me as a physician myself is to be able to offer patients potential solutions. I think when we first saw the phase I-B data in gastric cancer, the incredible improvement in progression-free survival on top of standard of care got us very excited. This was meaningful for patients. This is meaningful for their families. More than market size, I think for me, it's really that can we get the right balance between safety and efficacy for patients, especially with those with BTC and PDAC, very devastating diseases, and we'd love to just be able to offer something to those patients.
Maybe lastly on givastomig before we move on to the rest of your pipeline, how are you thinking about capital allocation and financing of the givastomig program, especially as it moves into a much larger registrational trial?
Yeah, t op priority for us is to ensure that we keep the program on track. I think we have a huge opportunity for patients that are not eligible for current standards because of the Claudin 18.2 low levels that they have. I t's really important for us to be able to keep the program moving forward, which is our top priority. In parallel, we're not letting sort of conversations, potentially with BD or other sort of solutions, potentially with investors sort of slow down our moving forward on the registrational trial. W e are in parallel having those conversations because as you can guess, a registrational trial of this scale is a meaningful financial commitment.
We are definitely pursuing multiple options in parallel, but primary focus is to make sure that, regardless of whether it's alone or with a partner or with the flexibility we have as our platform, is that we can also create dedicated subsidiary companies with other investors coming in. R egardless of that, I think the key thing is that staying on timeline and moving the program forward and advancing it is critical for us.
Actually, maybe one last question before we move on to the rest of your pipeline. For your readouts in BTC and PDAC, and I'm possibly most curious about the PDAC opportunity here, how are you thinking where givastomig could fit in as these pan-RAS and other RAS pathway targeting agents are coming online?
It's a great question. I think, again, this will depend on how the data bears out. We're still enrolling in our phase I cohort, so I think we'd love to see what it looks like. Incredible for the space to see what's happened with the pan-RAS and KRAS sort of additions to pancreatic cancer. O verall, very excited that we're able to start offering more solutions to those patients. W e are very much staying in tune with this, and as we're kind of advancing through the phase I cohort and looking at the data, we're curious to sort of see how the data helps us understand where this could fit in.
Yeah, I think that would be a fascinating opportunity, especially in a post-RAS setting.
Yeah, exactly.
Yeah. Would you like to introduce the rest of your pipeline or highlight any particular assets that you're excited about?
Yeah, so I am really excited actually to talk about our programs that are in our majority-owned company, Visara. For me, the givastomig is a great example of what we can do as a biotech company with a clinical team that is advancing a global program. Visara, for me, sort of shows the other part of our story, which is our incredible ability to find differentiated assets.
The backbone of Visara is a therapy called VIS-101. It is a VEGF-ANG2 that we started working on in collaboration with Everest Medicines in China, where in the phase II-A data, we started to see that the durability of the response could be almost to get to dosing to be twice a year, which would be an incredible benefit to patients and physicians to go down from four times a year to twice-a-year dosing.
We have been working, the phase II-A was run with Everest, and we are working with them right now on expanding that into phase II-B. O n top of sort of the table stakes in here is the visual acuity, but to be managing safety, to reduce the intraocular inflammation, and to get the durability to be there where we could actually have an implication for the dosing regimen, I think could be an incredible addition and differentiation in the space. T hat is sort of the backbone of this company that we have now as a majority-owned subsidiary of NovaBridge.
We are also thinking about expanding. We are in the process of expanding the portfolio with a couple of other ophthalmology assets. We are sort of in conversations for some things that are more front of the eye, and also really built on this idea that we can find things that are truly differentiated.
You said Visara is a subsidiary. What is the ownership relationship between NovaBridge?
NovaBridge is a 65% owner of Visara.
Okay. What would you need to see in the phase I-B, or how would you define success on these durability measures that you have seen that allowed you or that suggest you could dose twice annually in phase I-B in order to merit further development in -
Phase II-B. We are currently in progress or enrolling on a phase II-B study with about 100 patients for VIS-101, and it is being enrolled in China with our partner Everest. We are going to use or work in collaboration, use that to inform the phase III trial, which could start in 2027.
Okay.
That would just be the persistence of the response in terms of retreatment frequency and how many patients require retreatment based on best-corrected visual acuity after six months or nine months. We are going to follow the data, and then we will use that to inform the phase III trial, which we will do as a multi-regional clinical trial.
How are you thinking about the doses that you are taking forward into the phase II-B, and how are you going to balance the tolerability with the dosing and the efficacy signals on the visual acuity?
I think in the phase II-B, we'll be evaluating multiple doses, and then I think based on the results of that, we'll be able to inform the phase III trial. I think definitely intraocular inflammation is one of the things that we're always concerned about, but we can also manage that. I think as we're thinking about the CMC and the manufacturing, we can reduce some of that. We're kind of working on this in a multi-prong way. D efinitely multiple doses are being evaluated right now so that we can use that data to design the phase III.
Is the phase II-B going to be randomized? Are you putting some stats on what dose you might be taking forward, or is it descriptive analysis only?
I think it's randomized, and then it's enrolling now, so we'll be able to then see how the data bears out in the interim.
Okay. I guess, what is your base case scenario for you to make a go or a no-go decision on the phase III? What would it take for you to see?
I think, obviously efficacy has to be similar, if not better. I think for us, we are looking for a durability that we saw in the phase II-A, actually. We saw that about 67% of the patients did not require retreatment at six months and 50% at nine months. W e already sort of see a very strong signal from the II-A that suggests that we can evaluate the durability. I think if that persists through the expansion with the 100 patients, I think we're excited and confident that we're going to move forward with the phase III.
Sounds like a very exciting program in ophthalmology. How are you thinking about complementing VIS-101 with the other assets that you had already mentioned? You've said a little bit more to the front of the eye. How would your development team be able to support that? Would it be through another collaboration with Everest?
W e're very excited actually because I think the Visara team has shown us what we can do in terms of bringing talent together. When we acquired VIS-101, we were able to actually bring together an experienced CMO, CEO, and board that had worked extensively in ophthalmology. This is sort of for me, also a demonstration of where we can be as a company for NovaBridge, is not only is this the BD function, but then building the specialized team around the asset to continue to advance it.
Cadmus Rich is one of the CMO in the ophthalmology space that's advanced many, many programs to therapies for patients. Jeff Nau has done three IPOs for ophthalmology companies as a CEO. W e're very excited that we were able to bring that team together, in particular to continue to move forward the Visara programs.
I n terms of your question, I think that as we both look, the team is actually a critical piece of what we're looking for. Again, for us, it's not so much, what are we finding that we're thinking is a me too on the efficacy side? We're really looking at differentiation, which is the multifaceted approach for us. Just as an example, there's some therapies in ophthalmology for front of the eye for corneal diseases that require cold chain.
If we can find assets that can be developed with CMC that are cold chain independent, for us, we see that as a meaningful differentiation for patients. The ease of use, the ability to travel, for patients to be able to take them to work, to not have to be dependent on cold chain. I think those types of things we see as part of the differentiation.
As we look at companies and where we might acquire potential therapies, we want to be able to say, okay, the efficacy has to be at a bare minimum the same as where we are with the standard of care. NovaBridge hired a Chief Commercial Officer a few months back, and part of that for me was the signal that said a therapy only really matters when it gets to a patient. Innovation only matters when it actually gets to a patient. Using commercial thinking, market access benefits to patients as part of the story is actually our holistic way of making sure that whatever we bring in and choose to advance and use shareholder money for, can actually find its way to patients and change their lives.
Speaking of shareholder money and your pipeline and mention of acquisition of assets and therapies. Beyond VIS-101 and givastomig, what other assets other than front of the eye would you be interested in looking at? Are you married to oncology or ophthalmology, or are you agnostic to indications?
I think that's the beauty of the company model, and that's what excited me to come into the role, is that we can be agnostic to therapeutic areas and really focus on unmet need, and we can really focus on where we can find differentiation. Two places right now that we're really excited about because we have partners who are excited to work with us in this space, just as a preview, one is in women's health. We have a lot of unmet need in women's health in terms of innovation. Whether that be in endometriosis or that's in DMS, or PCOS or PMOS now it's called. I think we are really excited to be able to find ways that we can bring forward potential therapies for women in those spaces.
We actually have commercial partners or investors who would love to work with us on thinking about those assets, which has already given us some confidence that doing the search and eval work in that place, those therapies would already start to have the expertise and partners to bring them forward. The other area that we've been thinking a lot about, as you know, Daniel, and you're also from a European background, is there's a concern right now that there's not enough innovation making its way to patients in Europe for a variety of structural and other reasons.
Already with the fact that the European system is very different than the U.S. system in that market access is really government-driven, and therapies to get to the broadest number of patients with a very limited out-of-pocket market is really driven through whether or not there's national reimbursement.
That was already a structurally challenging thing for many companies. Compounded on that now, if we add the MFN reference countries, there's a lot of places where innovation is going to be held back from being launched in those countries just because of price considerations. We have been working and thinking with some of the European commercial companies that are very much prominent outside the U.S. but in Europe and rest of world, on what kinds of products, what kind of innovation could we work together where we do the BD work and the early clinical work, and they work on the market access and the commercial. How could we work together to make sure that we continuously bring the best potential therapies to patients outside of the largest markets.
D efinitely stay tuned. I think as we think about BD, we're thinking about other places that we might have unmet needs, and so those are two. We're open to lots of therapeutic areas. Our team is very well embedded in the China biotech system, the Korea biotech system, and broader in APAC. We're always keeping an eye out to see how we might think about things, and we're excited that we can find the capital and build the teams around those assets to make sure that they can get to patients.
Great. I think that was a great closing statement there, and that is all what we have time for. It was pleasure hosting you.
Thank you.