NovaBridge Biosciences American Depositary SharesNBP
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NovaBridge Biosciences American Depositary Shares 12th Annual Cantor Fitzgerald Global Healthcare Conference

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Transcript

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Daniel BranderAnalyst

Good afternoon, and welcome to day number 2 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.

Srishti GuptaCEO

Thank you, Daniel, and thank you everyone. NovaBridge is a global biotechnology company that really combines 3 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.

Srishti GuptaCEO

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.

Daniel BranderAnalyst

Great. I think you mentioned 2 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.

Srishti GuptaCEO

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.

Srishti GuptaCEO

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. So over PD-1 and FOLFOX or CAPOX, depending, so immunochemotherapy. And we'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.

Srishti GuptaCEO

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. And we are on top of immunochemotherapy, so we see a very practical use in the settings.

Daniel BranderAnalyst

And maybe for the ESMO update, what should we be expecting and looking for specifically at that update?

Srishti GuptaCEO

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 mgs per kg and 12 mgs per kg for patients. And continued 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. And we 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. Oh, okay.

Daniel BranderAnalyst

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?

Srishti GuptaCEO

No, it'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. But 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. And for 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. And then the other thing is for us, differentiation is multifold, right?

Srishti GuptaCEO

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.

Daniel BranderAnalyst

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?

Srishti GuptaCEO

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.

Srishti GuptaCEO

As we've gotten more sophisticated and are looking at the 1B 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.

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