Half Year 2026 NovaBridge Biosciences Earnings Call

August 20, 2026

Speaker #1: Good morning, and welcome to the NovaBridge Biosciences First Half 2026 Corporate Update and Financial Results call. At this time, all attendees are in listen-only mode.

Operator: Good morning, and welcome to the NovaBridge Biosciences H1 2026 corporate update and financial results call. At this time, all attendees are in listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this call is being recorded and a replay will be made available on the NovaBridge website following the conclusion of the event. Some of the statements made on this call will include forward-looking statements within the meanings of the US Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business, including those set forth in the Risk Factors section of NovaBridge's annual report on Form 20-F for the year ended 31 December 2025, and any other filings that are or may be made with the SEC.

Speaker #1: A question-and-answer session will follow the formal presentation. As a reminder, this call is being recorded, and a replay will be made available on the NovaBridge website following the conclusion of the event.

Speaker #1: Some of the statements made on this call will include forward-looking statements, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995.

Speaker #1: Actual results could differ materially from those stated or implied by these forward-looking statements, due to risks and uncertainties associated with the company's business, including those set forth in the risk factors section of NovaBridge's annual report on Form 20-F for the year ended December 31, 2025, and any other filings that are or may be made with the SEC.

Operator: Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business, including those set forth in the Risk Factors section of NovaBridge's annual report on Form 20-F for the year ended 31 December 2025, and any other filings that are or may be made with the SEC.

Speaker #1: Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation. In addition, our statements are based on information available to us as of today, August 20, 2026.

Operator: Please also carefully review the forward-looking statements disclaimer in the slide deck that accompanies this presentation. In addition, our statements are based on information available to us as of today, 20 August 2026. NovaBridge undertakes no obligation to revise or update any statements or information to reflect events or circumstances after the date of this conference call. I'd now like to turn the call over to Dr. Srishti Gupta, Chief Executive Officer of NovaBridge Biosciences. Please go ahead, Srishti.

Speaker #1: NovaBridge undertakes no obligation to reflect events or circumstances after the date of this conference call. I'd now like to turn the call over to Dr. Hristi Gupta, Chief Executive Officer of NovaBridge Biosciences.

Speaker #1: Please go ahead, Hristi.

Speaker #2: Thank you, Tara. Thank you, everyone, for joining us today. For those of you whom I have not yet had the pleasure to meet, I'm Hristi Gupta, Chief Executive Officer at NovaBridge.

Srishti Gupta: Thank you, Tara. Thank you everyone for joining us today. For those of you I've not yet had the pleasure to meet, I'm Srishti Gupta, Chief Executive Officer at NovaBridge. It is really an honor to be here. I joined the company in July, so this is my first earnings call as CEO. Before discussing our H1 results and our portfolio progress, I'd like to spend a few minutes sharing why I joined NovaBridge and how I think about the opportunity ahead of us. Throughout my career, whether as a physician, a healthcare advisor, a board member, or most recently as a CEO of a global biopharmaceutical company, I have been motivated by a simple belief. Exceptional science only matters if it reaches patients. Too often, though, promising medicines never reach their full potential. In many cases, the challenge is not the quality of the science itself.

Speaker #2: It is really an honor to be here. I joined the company in July, so this is my first earnings call as CEO. Before discussing our first-half results and our portfolio progress, I'd like to spend a few minutes sharing why I joined NovaBridge and how I think about the opportunity ahead of us.

Speaker #2: Throughout my career, whether as a physician, a healthcare advisor, a board member, or, most recently, as CEO of a global biopharmaceutical company, I have been motivated by a simple belief: exceptional science only matters if it reaches patients.

Speaker #2: Too often, though, promising medicines never reach their full potential. In many cases, the challenge is not the quality of the science itself. The challenge is advancing that science through development, regulatory review, financing, and ultimately, commercialization.

Srishti Gupta: The challenge is advancing that science through development, regulatory review, financing, and ultimately commercialization. That is what attracted me to NovaBridge. I believe the company has an opportunity to occupy a differentiated position in today's biotechnology landscape. Our goal is straightforward: To identify promising new medicines, advance them efficiently, and pursue the path that gives each program the best opportunity to succeed. We are working to bridge the gap between exceptional science and patient impact. Next slide, please. The opportunity to do this has never been greater. Today, more promising new medicines are being developed around the world than any point in our industry's history. We are especially seeing this in Asia, which has become an increasingly important source of new medicines and global licensing activity. But the point is not where the science originates. Where a medicine starts is becoming less important than how it is advanced.

Speaker #2: That is what attracted me to NovaBridge. I believe the company has an opportunity to occupy a differentiated position in today’s biotechnology landscape. Our goal is straightforward: to identify promising new medicines, advance them efficiently, and pursue the path that gives each program the best opportunity to succeed.

Speaker #2: We are working to bridge the gap between exceptional science and patient impact. Next slide, please. The opportunity to do this has never been greater.

Speaker #2: Today, more promising new medicines are being developed around the world than at any point in our industry's history. We are especially seeing this in Asia, which has become an increasingly important source of new medicines and global licensing activity.

Speaker #2: But the point is not where the science originates. Where our medicines start is becoming less important than how they are advanced. We believe that capability is becoming increasingly important across our industry, and NovaBridge is well positioned at the intersection of innovation and translation.

Srishti Gupta: We believe that the capability is becoming increasingly important across our industry, and NovaBridge is well-positioned at the intersection of innovation and translation. Next slide, please. NovaBridge has three key strengths. First, access. Through our relationships, networks, and experience, we believe we can identify promising opportunities, including therapies that others may overlook. Second, development expertise. We have the experience to advance programs through clinical development, generate meaningful proof-of-concept data, and make informed decisions about the best path forward. Third, capital allocation discipline. We do not believe that every potential new therapy should follow the same path. The right development, financing, or partnering strategy should be determined by the needs of the program. Structure should follow the asset and not the other way around. For us, this is not just a theoretical framework. Our two lead programs already demonstrate different aspects of this approach.

Speaker #2: Next slide, please. NovaBridge has three key strengths. First, access. Through our relationships, networks, and experience, we believe we can identify promising opportunities, including therapies that others may overlook.

Speaker #2: Second, development expertise. We have the experience to advance programs through clinical development, generate meaningful proof-of-concept data, and make informed decisions about the best path forward.

Speaker #2: And third, capital allocation discipline. We do not believe that every potential new therapy should follow the same path. The right development, financing, or partnering strategy should be determined by the needs of the program.

Speaker #2: Structure should follow the asset, and not the other way around. For us, this is not just a theoretical framework. Our two lead programs already demonstrate different aspects of this approach.

Speaker #2: Jiva Someg reflects our ability to advance a promising program toward registrational development. Viz 101 reflects our ability to identify an attractive opportunity, acquire it, and build a focused organization around it.

Srishti Gupta: givastomig reflects our ability to advance a promising program towards registrational development. VIS-101 reflects our ability to identify an attractive opportunity, acquire it, and build a focused organization around it. Next slide, please. Let me make this more concrete through our lead oncology program, givastomig. Beyond the promise of the medicine itself, I believe givastomig demonstrates what disciplined execution can accomplish. Since the initial phase I-B data presentation in July 2025, we have rapidly advanced the program towards a potential registrational path. Next slide, please. What stands out to me is the pace of progress over the past year. During the H1 2026, we reported updated phase I-B results, initiated our global randomized phase II study, and made important regulatory progress.

Srishti Gupta: Givastomig reflects our ability to advance a promising program towards registrational development. VIS-101 reflects our ability to identify an attractive opportunity, acquire it, and build a focused organization around it. Next slide, please. Let me make this more concrete through our lead oncology program, givastomig. Beyond the promise of the medicine itself, I believe givastomig demonstrates what disciplined execution can accomplish. Since the initial phase I-B data presentation in July 2025, we have rapidly advanced the program towards a potential registrational path. Next slide, please. What stands out to me is the pace of progress over the past year. During the H1 2026, we reported updated phase I-B results, initiated our global randomized phase II study, and made important regulatory progress.

Speaker #2: Next slide, please. Let me make this more concrete through our lead oncology program, Jiva Someg. Beyond the promise of the medicine itself, I believe Jiva Someg demonstrates what disciplined execution can accomplish.

Speaker #2: Since the initial Phase 1B data presentation in July 2025, we have rapidly advanced the program toward a potential registrational path. Next slide, please. What stands out to me is the pace of progress over the past year.

Speaker #2: During the first half of 2026, we reported updated Phase 1B results, initiated our global randomized Phase 2 study, and made important regulatory progress. Following our Type JIVA, Someg may be eligible for an accelerated approval pathway in first-line HER2-negative, CLDN18.2-positive, PD-L1-positive gastroesophageal cancer.

Srishti Gupta: Following our Type B meeting with the FDA, we announced that givastomig may be eligible for an accelerated approval pathway in first-line, HER2 negative, Claudin 18.2 positive, PD-L1 positive gastroesophageal cancer. In June, the FDA granted Fast Track designation for givastomig in combination with nivolumab and chemotherapy. Taken together, these milestones have increased our confidence in the development pathway for the program. Looking ahead, we expect to present the updated phase I-B dose expansion data at ESMO in October, and subject to ongoing planning and financing activities, continue to target initiation of a phase III study as early as the Q4 of this year. Next slide, please. Let me now turn to why we are excited about givastomig.

Speaker #2: And in June, the FDA granted fast-track designation for Jiva Someg in combination with nivolumab and chemotherapy. Taken together, these milestones have increased our confidence in the development pathway for the program.

Speaker #2: Looking ahead, we expect to present the updated Phase 1b dose expansion data at ASMO in October and, subject to ongoing planning and financing activities, continue to target initiation of a Phase 3 study as early as the fourth quarter of this year.

Speaker #2: Next slide, please. Let me now turn to why we're excited about Jiva Someg. As we look at the competitive landscape, we believe Jiva Someg has the potential to become an important first-line treatment option for patients with HER2-negative, Claudin 18.2-positive gastric and gastroesophageal junction cancer.

Srishti Gupta: As we look at the competitive landscape, we believe givastomig has the potential to become an important first-line treatment option for patients with HER2 negative, Claudin 18.2 positive gastric and gastroesophageal junction cancer. Three characteristics really stand out. First is the strong activity when added to standard immunochemotherapy. In the phase I-B study, we observed encouraging response rates, disease control, and progression-free survival across the combination cohorts. Second, there is activity across a broad range of Claudin 18.2 expression levels. Responses were observed across both higher and lower expression groups, which could support applicability across a broader patient population. Third, we believe practical adoption matters. givastomig is being developed as a conventional antibody therapy that can be integrated into existing treatment practice across a broad range of care settings.

Speaker #2: Three characteristics really stand out. First is strong activity when added to standard immunochemotherapy. In the phase 1b study, we observed encouraging response rates, disease control, and progression-free survival across the combination cohorts.

Speaker #2: Second, there's activity across a broad range of clotting 18.2 expression levels. Responses were observed across both higher and lower expression groups, which could support applicability across a broader patient population.

Speaker #2: And third, we believe practical adoption matters. Jiva Someg is being developed as a conventional antibody therapy that can be integrated into existing treatment practices across a broad range of care settings.

Speaker #2: Taken together, we believe these attributes support the potential for Jiva Someg to become a differentiated first-line treatment option and reinforce our continued focus on advancing the program toward registrational development.

Srishti Gupta: Taken together, we believe these attributes support the potential for givastomig to become a differentiated first-line treatment option and reinforce our continued focus on advancing the program towards registrational development. Next slide, please. I would like to turn to our ophthalmology program. VIS-101 is being advanced through Visara, NovaBridge's majority-owned ophthalmology subsidiary. We identified ophthalmology as an area with significant unmet need, particularly for therapies that can improve durability and reduce treatment burden. VIS-101 became the foundation of that effort. We acquired what we believe was a differentiated asset and assembled an experienced ophthalmology leadership team, including the appointment of Dr. Jeff Nau as Chief Executive Officer of Visara, to lead the next phase of development. Today, VIS-101 remains our lead ophthalmology program, and we continue to evaluate additional opportunities within the field over time. Next slide, please. We were initially attracted to VIS-101 because of a simple observation.

Speaker #2: Next slide, please. I would like to turn to our ophthalmology program. VIZ-101 is being advanced through Vissara, NovaBridge’s majority-owned ophthalmology subsidiary. We identified ophthalmology as an area with significant unmet need, particularly for therapies that can improve durability and reduce treatment burden.

Speaker #2: Viz 101 became the foundation of that effort. We acquired what we believe was a differentiated asset and assembled an experienced ophthalmology leadership team, including the appointment of Dr. Jeff Nao as Chief Executive Officer of Vissara to lead the next phase of development.

Speaker #2: Today, Viz 101 remains our lead ophthalmology program, and we continue to evaluate additional opportunities within the field over time. Next slide, please. We were initially attracted to Viz 101 because of a simple observation.

Speaker #2: In retinal vascular disease, outcomes have improved dramatically over the last decade, but treatment burden remains a significant challenge for patients and physicians. We believe durability remains one of the most important opportunities for innovation in ophthalmology.

Srishti Gupta: In retinal vascular disease, outcomes have improved dramatically over the last decade, but treatment burden remains a significant challenge for patients and physicians. We believe durability remains one of the most important opportunities for innovation in ophthalmology. VIS-101 was purpose-designed to address that challenge. It is the only tetravalent VEGF-A and Ang-2 peptibody with two binding sites for each target and a molecular design intended to provide both robust inhibition and extended durability. That differentiated profile is what initially attracted us to this therapy. Positive phase IIa top line results from earlier this year demonstrated improvements in visual acuity, reductions in retinal thickness, durable treatment responses, and a favorable safety profile. Based on those results, we are preparing to initiate a phase IIb study in the H2 of this year, with the goal of further defining the optimal dose and advancing the program towards global phase III development.

Speaker #2: Viz 101 was purpose-designed to address that challenge. It is the only tetravalent VEGFA and anti-2 peptide body with two binding sites for each target, and a molecular design intended to provide both robust inhibition and extended durability.

Speaker #2: That differentiated profile is what initially attracted us to this therapy. Positive Phase 2a top-line results from earlier this year demonstrated improvements in visual acuity, reductions in retinal thickness, durable treatment responses, and a favorable safety profile.

Speaker #2: Based on those results, we're preparing to initiate a Phase 2b study in the second half of this year, with the goal of further defining the optimal dose and advancing the program toward global Phase 3 development.

Speaker #2: Together, Jiva Someg and Viz 101 illustrate two aspects of NovaBridge's approach. One reflects our ability to advance a promising medicine through development. The other reflects our ability to identify attractive opportunities, acquire differentiated assets, and build focused organizations around them.

Srishti Gupta: Together, givastomig and VIS-101 illustrate two aspects of NovaBridge's approach. One reflects our ability to advance a promising medicine through development. The other reflects our ability to identify attractive opportunities, acquire differentiated assets, and build focused organizations around them. These are the programs on which we are primarily focused today, and we believe both have important milestones ahead. With that, I will turn the call over to Kyler to review our H1 financial results.

Speaker #2: These are the programs on which we're primarily focused today, and we believe both have important milestones ahead. With that, I'll turn the call over to Kyler to review our first-half financial results.

Speaker #1: Thank you, Trishti. And good morning, good evening, everyone. Nice spot, please. As of June 30, 2026, NovaBridge had approximately $216 million in cash and investments, consisting of approximately $191 million in cash and cash equivalents, and approximately $25 million in equity investments at fair value.

Kyler Lei: Thank you, Srishti, and good morning, good evening, everyone. Next slide, please. As of 30 June 2026, NovaBridge had approximately $216 million in cash and investments, consisting of approximately $191 million in cash and cash equivalent and approximately $25 million in equity investment at fair value. Notably, this is a debt-free balance sheet continuing to be strong, which provides us with meaningful financial flexibility as we execute our strategic priorities. As you can see on this slide, our current financial resources are expected to support NovaBridge through a number of important clinical and strategic inflection points across the portfolio. For givastomig, this includes updated phase Ib dose expansion data at ESMO 2026, completion of enrollment in the phase II first-line gastroesophageal adenocarcinoma combination study, and the potential initiation of the phase III registrational program as early as year-end 2026.

Speaker #1: Notably, this is a debt-free balance sheet, continuing to be strong, which provides us with meaningful financial flexibility as we execute our strategic priorities. As you can see on this slide, our current financial resources are expected to support NovaBridge through a number of important clinical and strategic inflection points across the portfolio.

Speaker #1: For Jiva Someg, this includes updated Phase 1b dose expansion data at ASMO 2026, completion of enrollment in the Phase 2 first-line gastroesophageal adenocarcinoma combination study, and the potential initiation of the Phase 3 registrational program as early as year-end 2026.

Speaker #1: Looking ahead, our current runway extends through the anticipated Phase 3 interim data readout in 2028 for Jiva Someg. Our financial position also supports continued development of VIZ 101, including initiation and interim data readout of the Phase 2b neovascular AMD study, as well as the planned Phase 3 initiation.

Kyler Lei: Looking further ahead, our current runway extends through the anticipated phase III interim data readout in 2028 for givastomig. Our financial position also supports continued development of VIS-101, including initiation and interim data readout of the phase IIb neovascular AMD study and the planned phase III initiation as well as additional clinical milestones across the broader portfolio. As Srishti discussed, disciplined capital allocation is a fundamental strength of the NovaBridge strategy, and we intend to deploy capital thoughtfully around programs and opportunities where we believe we can create a meaningful value while maintaining the flexibility to pursue the financing, partnering or corporate structure best suited to each asset. We believe our current balance sheet puts us in a strong position to execute that strategy while advancing the portfolios through multiple important value inflection points. With that, I'll turn the call back to Srishti for closing remarks. Srishti, back to you.

Speaker #1: As well as additional clinical milestones across the broader portfolio. As Trishti discussed, disciplined capital allocation is a fundamental strength of the NovaBridge strategy, and we intend to deploy capital thoughtfully around programs and opportunities where we believe we can create meaningful value, while maintaining the flexibility to pursue the financing, partnering, or corporate structure best suited to each asset.

Speaker #1: We believe our current balance sheet puts us in a strong position to execute that strategy, while advancing the portfolio through multiple important value inflection points.

Speaker #1: With that, I'll turn the call back to Trishti for closing remarks. Trishti, back to you.

Speaker #2: Thank you, Kyler. Next slide, please. I want to highlight the catalysts we expect investors to be watching over the coming quarters. For Jiva Someg, our near-term focus remains execution across the broader development program.

Srishti Gupta: Thank you, Kyler. Next slide, please. I want to highlight the catalyst we expect investors to be watching over the coming quarters. For givastomig, our near-term focus remains execution across the broader development program. Key milestones include updated phase I-B dose expansion data at ESMO, continued advancement of our randomized phase II study in first-line gastric cancer, initiation of a phase III study as early as Q4 of this year, subject to ongoing planning and financing activities, and continued enrollment of our biliary tract cancer and pancreatic cancer cohort. For VIS-101, we're preparing to initiate the phase IIb program in H2 2026 and continue advancing the program towards global phase III development. As I reflect on H1 2026, what excites me the most is not only the progress of givastomig and VIS-101, but what those programs represent.

Speaker #2: Key milestones include updated Phase 1b dose expansion data at ASCO, continued advancement of our randomized Phase 2 study in first-line gastric cancer, initiation of a Phase 3 study as early as the fourth quarter of this year (subject to ongoing planning and financing activities), and continued enrollment of our biliary tract cancer and pancreatic cancer cohorts.

Speaker #2: For Viz 101, we're preparing to initiate the Phase 2B program in the second half of 2026 and continue advancing the program toward global Phase 3 development.

Speaker #2: As I reflect on the first half of 2026, what excites me the most is not only the progress of JivaSomeg and Viz 101, but what those programs represent.

Speaker #2: Jiva Someg and Viz 101 followed very different paths, but both reflect the same underlying objective: identifying promising medicines and helping them reach their full potential.

Srishti Gupta: Givastomig and VIS-101 followed very different paths, but both reflect the same underlying objective, identifying promising medicines and helping them reach their full potential. They represent two aspects of the NovaBridge approach. In one case, we are advancing a promising oncology program towards potential registration. In the other, we identified an opportunity in ophthalmology, acquired a differentiated asset, and built a focused and talented organization around it. Beyond givastomig and VIS-101, our portfolio also includes programs such as ragistomig and uliledlimab, where development programs are currently being led by our partners. While our primary focus remains on givastomig and VIS-101, we continue to monitor the progress of these programs and look forward to future data readouts. Looking ahead, our priorities are straightforward. Advance givastomig and VIS-101, deliver on the milestones in front of us, and continue strengthening the organization to support future growth.

Speaker #2: They represent two aspects of the NovaBridge approach. In one case, we are advancing a promising oncology program toward potential registration; in the other, we identified an opportunity in ophthalmology, acquired a differentiated asset, and built a focused and talented organization around it.

Speaker #2: Beyond Jiva Someg and Viz 101, our portfolio also includes programs such as Raji Someg and Uli Litabab, where development programs are currently being led by our partners.

Speaker #2: While our primary focus remains on Jiva Someg and Viz 101, we continue to monitor the progress of these programs and look forward to future data readouts.

Speaker #2: Looking ahead, our priorities are straightforward: advance Jiva Someg and Viz 01, deliver on the milestones in front of us, and continue strengthening the organization to support future growth.

Speaker #2: Ultimately, I joined NovaBridge because it was built to identify promising medicines, advance them thoughtfully, and give them the best opportunity to reach patients who may benefit from them.

Srishti Gupta: Ultimately, I joined NovaBridge because it was built to identify promising medicines, advance them thoughtfully, and give them the best opportunity to reach patients who may benefit from them. We are still early in that journey, but I'm encouraged by the progress we have made so far. Next slide, please. With that, Tara, we'd be happy to take questions.

Speaker #2: We are still early in that journey, but I'm encouraged by the progress we have made so far. Next slide, please. With that, Tara, we'd be happy to take questions.

Speaker #3: Great. Thank you, Trishti. So, yes, at this time we will be conducting a question-and-answer session with our speakers. To our analysts who have joined us live, please use the raise hand feature to indicate you have a question.

Operator: Great. Thank you, Srishti. At this time, we will be conducting a question and answer session with our speakers. To our analysts who have joined us live, please use the raise hand feature to indicate you have a question. Please hold for a brief moment while we pull for questions. Our first question comes from Daina Graybosch at Leerink Partners. Please go ahead.

Speaker #3: Please hold for a brief moment while we pull questions. Our first question comes from Dana Greybosh at Lyrinc Partners. Please go ahead.

Speaker #4: Hi, thank you. Thanks for the question. I wonder if you could talk a bit more about the future growth platforms and why we should have confidence that NovaBridge is particularly differentiated, or well-suited to take advantage of European gaps?

Daina Graybosch: Hi. Thank you. Thanks for the question. I wonder if you could talk a bit more about the future growth platforms and why we should have confidence that NovaBridge is particularly differentiated or well-suited to take advantage of European gaps, and maybe if you could give us some examples of what you mean by that, and also women's health. I guess they are both very different from givastomig, a highly innovated IO asset in Visara. Thank you.

Speaker #4: And maybe you could give us some examples of what you mean by that, and also Women's Health. I guess they're both very different from Jiva.

Speaker #4: A highly innovative IO asset and Vistara. Thank you.

Speaker #2: Thank you, Dana, for the question. I just wanted to let everyone know that, in addition to Kyler and myself, I'm joined by Mark Hegler, our Chief Commercial Officer; Dr. Phil Dennis, our Chief Medical Officer; and Jeff Now, the CEO of Vistara.

Srishti Gupta: Thank you, Dana, for the question. I just wanted to let everyone know that in addition to Kyler and myself, I am joined by Mark Hagler, our Chief Commercial Officer, Dr. Phil Dennis, our Chief Medical Officer, and Jeff Nau, the CEO of Visara. In case there are questions, we have our executive team here today. Dana, on your question, I will start and I would love to turn it over to Mark as well. I think as we think about our future growth platforms, for us, it is really the combination of the capabilities of having both the business development as well as the internal clinical development.

Srishti Gupta: Thank you, Daina, for the question. I just wanted to let everyone know that in addition to Kyler and myself, I am joined by Mark Hagler, our Chief Commercial Officer, Dr. Phil Dennis, our Chief Medical Officer, and Jeff Nau, the CEO of Visara. In case there are questions, we have our executive team here today. Daina, on your question, I will start and I would love to turn it over to Mark as well. I think as we think about our future growth platforms, for us, it is really the combination of the capabilities of having both the business development as well as the internal clinical development.

Speaker #2: In case there are questions, we have our executive team here today. And Dana, on your question, I'll start, and I'd love to turn it over to Mark as well.

Speaker #2: But I think, as we think about our future growth platforms, for us, it's really the combination of the capabilities of having both business development as well as internal clinical development.

Speaker #2: And not to be able to do either one of those things one-off, but to repeatedly do those things over and over again—to combine strong BD function with a strong internal clinical development function—so that we can take assets to their next value inflection point on their journey to become medicines.

Srishti Gupta: Not to be able to do either one of those things one-off, but to repeatedly do those things over and over again, to combine strong BD function with a strong internal clinical development function so that we can take assets to their next value inflection point on their journey to become medicine. You asked specifically about European gaps. We are in early days on our strategy on Europe, but we have been in conversations with several European commercial organizations on how to combine the strengths of a BD team, which is looking at a broad range of innovation, which especially is innovation that is differentiated at the clinic level and can be differentiated in comparison to comparators, and how to combine our functions, potentially even our clinical development for early regulatory milestones with their strong commercial capabilities and their market access.

Speaker #2: You asked specifically about European gaps. So, we're in the early days of our strategy for Europe, but we have been in conversations with several European commercial organizations on how to combine the strengths of a BD team, which is looking at a broad range of innovation—especially innovation that is differentiated at the clinic level and can be differentiated in comparison to comparators.

Speaker #2: And how to combine our functions, potentially even our clinical development for early regulatory milestones, with their strong commercial capabilities and their market access. So, we haven't quite identified which parts of the therapeutic area we would like to combine our efforts on, but there is definitely a strong amount of interest right now in bringing innovative assets in that have yet to be introduced into the broader market reimbursement systems for the European context.

Srishti Gupta: We haven't quite identified which parts of the therapeutic area we would like to combine our efforts on, but there is definitely a strong amount of interest right now on bringing innovative assets in that have yet to be introduced into the broader market reimbursement systems for the European context.

Speaker #2: Before I go into the Women's Health question, maybe, Mark, I'll turn it over to you from a commercial standpoint to maybe comment a little bit on how you think about our differentiation combined with our commercial capabilities.

Srishti Gupta: Before I go onto the women's health question, maybe Mark, I'll turn it over to you from a commercial standpoint to maybe comment a little bit on how you think about our differentiation combined with commercial capabilities.

Speaker #5: Sure. Thanks very much, Trishti. Yeah, I think I'll speak a little bit about the unmet need in Europe as well. I think that MFN has provided an opportunity within the European markets.

Mark Hagler: Sure. Thanks very much, Srishti. I'll speak a little bit about the unmet need in Europe as well. I think that MFN has provided an opportunity within the European markets. There's certainly a lot of interest from European companies to partner. Srishti's had a number of conversations already, and it's a fertile market, I would say. Again, it's very early and the final rules for GloBE and GUARD have not been released. But we've already seen a number of large global pharmaceutical companies launch in the US and not file in the EU. There's certainly opportunity there from our perspective. Srishti?

Speaker #5: There's certainly a lot of interest from European companies to partner. So Trishti's had a number of conversations already, and it's a fertile market. I would say, again, it's very early, and the final rules for Globe and Guard have not been released.

Speaker #5: But we've already seen a number of large global pharmaceutical companies launch in the US and not file in the EU. So there's certainly opportunity there from our perspective.

Speaker #5: Trishti?

Speaker #2: Thank you, Mark. So, Dana, just to kind of wrap up on the European partnership examples that we're thinking about: we're very much thinking of it as a partnership, where we combine our skills with their skills, and they have not had the need or ability yet to invest in large-scale BD functions in this part of the innovation landscape.

Srishti Gupta: Thank you, Mark. Dana, just to kind of wrap up on the European in partnership examples that we're thinking about, we're very much thinking of it as a partnership where we combine our skills with their skills, and they have not had the need/ability yet to invest in large scale BD functions in this part of the innovation landscape. That's part of what we would like to do. For many organizations, I think they struggle on how to allocate financing towards R&D when it hasn't been put into budgets. We also have the capabilities to host and advance things from an R&D perspective. We're still learning and we're very early days. We haven't commercialized anything in terms of our portfolio, so we see this as a combination of our strengths and their strengths. Then maybe to move on to the women's health question.

Srishti Gupta: Thank you, Mark. Daina, just to kind of wrap up on the European in partnership examples that we're thinking about, we're very much thinking of it as a partnership where we combine our skills with their skills, and they have not had the need/ability yet to invest in large scale BD functions in this part of the innovation landscape. That's part of what we would like to do. For many organizations, I think they struggle on how to allocate financing towards R&D when it hasn't been put into budgets. We also have the capabilities to host and advance things from an R&D perspective. We're still learning and we're very early days. We haven't commercialized anything in terms of our portfolio, so we see this as a combination of our strengths and their strengths. Then maybe to move on to the women's health question.

Speaker #2: So that's part of what we would like to do. And for many organizations, I think they struggle with how to allocate financing towards R&D when it hasn't been built into budgets.

Speaker #2: And so we also have the capabilities to host and advance things from an R&D perspective. We're still learning, and we're very early days. We haven't commercialized anything in terms of our portfolio.

Speaker #2: So we see this as a combination of our strengths and their strengths. And then, maybe to move on to the women's health question—again, this is an area of high unmet need.

Srishti Gupta: Again, this is an area of high unmet need. We have not seen a lot of innovation in either those therapeutics or potential therapeutics for areas that are really focused on women's specific disease areas. For example, endometriosis or menopause or poly metabolic ovarian syndrome. We also haven't seen a lot of necessary innovation in terms of the areas that are predominantly affecting women or disproportionately affecting women. So osteoporosis, osteopenia, sarcopenia, autoimmune. As we look at some of the MOA that are in the innovation landscape, we see potential to bring those forward in a variety of indications, including things that have not yet been addressed. We see also a lot of interest from financing partners to find that type of innovation and continue to advance it. Specific areas that we're tending to look at right now are endometriosis, menopause.

Speaker #2: We have not seen a lot of innovation in either those therapeutics or potential therapeutics for areas that are really focused on women-specific disease areas—for example, endometriosis, menopause, or polycystic ovarian syndrome.

Speaker #2: And we also haven't seen a lot of necessary innovation in terms of the areas that are predominantly affecting women or disproportionately affecting women—so osteoporosis, osteopenia, sarcopenia, autoimmune.

Speaker #2: And so, as we look at some of the MOAs that are in the innovation landscape, we see potential to bring those forward in a variety of indications, including things that have not yet been addressed.

Speaker #2: We see also a lot of interest from financing partners to find that type of innovation and continue to advance it. Specific areas that we're tending to look at right now are endometriosis, menopause—can we innovate in the injectable fertility space, which has been heavily dependent on injectable drugs.

Srishti Gupta: Can we innovate in the injectable fertility space, which has been heavily dependent on injectable drugs? How do we think about what used to be called polycystic ovarian syndrome and now, PMOS? So those are types of areas that we're thinking about, as well as osteoporosis, osteopenia, and sarcopenia, which are disproportionately affecting women. So we're looking at a range of mechanisms of action, and we're trying to think about how we would advance those MOA towards potential therapeutics. Any follow on, Daina, before we take another question?

Speaker #2: How do we think about what used to be called polycystic ovarian syndrome, and now PCOS? So those are types of areas that we're thinking about, as well as osteoporosis, osteopenia, and sarcopenia, which are disproportionately affecting women.

Speaker #2: So we're looking at a range of mechanisms of action, and we're trying to think about how we would advance those MOAs toward potential therapeutics.

Speaker #2: Any follow-on, Dana, before we take another question?

Speaker #3: Maybe just to confirm the Europe point. So, because of your unique BD capabilities in China, this is really a fast-following strategy. So, a US or global company focused on the US market—and you see ability with lower clinical risk—to take great assets from China and fast follow and launch, potentially at a lower price, in the European market.

Daina Graybosch: Maybe just to confirm the Europe point. So because of your unique BD capabilities in China, this is really a fast follower. So a US or global company focused on the US market, and you see ability with lower clinical risk to take great assets from China and fast follow and launch potentially at a lower price in the Europe market. Is that fair?

Speaker #3: Is that fair?

Speaker #2: Yeah, I think I would summarize it as three things. I think differentiation is very contextual. So what we've been looking at in terms of differentiation at a global market is almost sort of a misnomer.

Srishti Gupta: Yeah, I think that I would summarize it as three things. I think differentiation is very contextual. What we've been looking at in terms of differentiation at a global market is almost sort of a misnomer. Differentiation in the European market is really differentiated compared to the standard of care that's reimbursed within the system. So you could say it's a fast follower, or you could say that it's a be better, but it's an improvement over what the national reimbursement systems are actually willing to pay for in terms of broad patient access. So this is for us, sort of the number one entry point is how do we think about where these therapeutics can come in compared to the standard of care?

Speaker #2: Differentiation in the European market is really differentiated compared to the standard of care that's reimbursed within the system. So you could say it's a fast follower, or you could say that it's a bit better.

Speaker #2: But it is an improvement over what the national reimbursement systems are actually willing to pay for in terms of broad patient access. So, for us, this is sort of the number one entry point: how do we think about where these therapeutics can come in compared to the standard of care.

Speaker #2: The second, for us, is the idea that when we're looking at data and generating our data through our clinical development team, we're hopeful that we can leverage data that's generated for at least the early parts of the, for Phase 1, Phase 2 data that's generated outside of Europe, in order to advance the regulatory pathway forward.

Srishti Gupta: The second for us is the idea that when we're looking at data and generating our data through our clinical development team, we're hopeful that we can leverage data that's generated for at least in early parts of the for phase I, phase II data that's generated outside of Europe in order to advance the regulatory pathway forward. I think the third thing for us is that we would love to combine that with low-cost potential manufacturing, which doesn't have such requirements to be localized to Europe, per se. The combination of finding an unmet need where the standard has not kind of been advanced for innovation with a regulatory pathway that's efficient because of the types of data that we can leverage as well as the manufacturing that can result in overall cost of goods, which could fit into these national health systems.

Speaker #2: I think the third thing for us is that we would love to combine that with low-cost potential manufacturing, which doesn't have such requirements to be localized to Europe per se.

Speaker #2: And so, the combination of finding an unmet need where the standard has not been advanced for innovation, with a regulatory pathway that's efficient because of the types of data that we can leverage, as well as manufacturing that can result in an overall cost of goods which could fit into these national health systems, we're hoping to work with commercial partners and their market access teams on integrating some of that type of innovation into the systems in which they're already operating.

Srishti Gupta: We're hoping to work with commercial partners with their market access teams on integrating some of that type of innovation into the systems in which they're already operating.

Speaker #3: Maybe one follow-up, just to make it concrete. Is there a great example from a competitor where you think that something meets these three criteria, and you'd look to that as an example of what 'good' will look like?

Daina Graybosch: Maybe one follow-up just to make it concrete. Is there a great example from a competitor where you think that something that these three criteria and you'd look to that to be this is what good will look like, or is this more a vision on the future?

Speaker #3: Or is this more a vision for the future?

Speaker #2: I think what we're seeing are a couple of things. I mean, recently Menarini announced a deal with the GLP-1 company coming out of China, knowing that that has been sort of a challenging reimbursement context for many countries—whether it's the obesity criteria, the diabetes criteria, or how to integrate GLP usage into the national health systems at scale has not sort of consistently been done.

Srishti Gupta: Well, we're seeing a couple things. Recently, Menarini announced a deal with a GLP-1 company coming out of China, knowing that that has been sort of a challenging reimbursement context for many countries, whether it's the obesity criteria, the diabetes criteria, how to integrate GLP usage into the national health systems at scale has not sort of consistently been done. So I'm guessing as Menarini is working up that clinical development program, they're going to do a comparator-based trial so that they can actually figure out how to get that through market access in the European five countries in which they're operating. But that, for me, is sort of a signal of, hey, we recognize that we're behind on innovating. I find it very interesting as just living in Europe myself, that PCSK9 inhibitors are not nationally reimbursed in many contexts over statins.

Speaker #2: So I'm guessing, as Menarini is working up that clinical development program, they're going to do a comparator-based trial so that they can actually figure out how to get that through market access in the European five countries in which they're operating.

Speaker #2: But that, for me, is sort of a signal of, hey, we recognize that we're behind on innovating. I find it very interesting, just living in Europe myself, that PCSK9 inhibitors are not nationally reimbursed in many contexts.

Speaker #2: Over-statins. And so, how do you think about what is driving that? It's probably cost, right? To be able to get a government to want to pay for that level of innovation—or what they perceive as sort of a costly innovation—for an entire population of people.

Srishti Gupta: How do you think about what is driving that? It is probably cost, right, to be able to get a government to want to pay for that level of innovation or what they perceive as sort of a costly innovation for an entire population of people. How could we figure out how to bridge that in order to bring an innovation that is a highly effective innovation, such as a PCSK9 inhibitor, into a health system? Those are the types of examples that are more in the sort of cardiac primary care. I am sure as we think about even more specialized areas that have biomarker-driven strategies where the data can translate because the screening has been biomarker-driven, can we do more in other areas?

Speaker #2: So, how could we figure out how to bridge that in order to bring an innovation that is a highly effective innovation, such as a PCSK9 inhibitor, into a health system?

Speaker #2: So, those are the types of examples that are more in the, sort of, cardiac primary care. But I'm sure as we think about even more specialized areas that have biomarker-driven strategies, where the data can translate because the screening has been biomarker-driven, we can do more in other areas.

Speaker #2: But that's a little bit about how we're thinking regarding the type of step-up we want to bring to patients, regardless of what geography they're in.

Srishti Gupta: That is a little bit around how we are thinking about the type of step up that we want to bring to patients, regardless of what geography they are in.

Daina Graybosch: Okay. Thank you.

Speaker #3: Okay. Thank you.

Speaker #1: Thanks for the questions, Dana. Our next question comes from Andre Smaldonato at HC Wainwright. Please go ahead, Andre.

Operator: Thanks for the questions, Dana. Our next question comes from Andres Maldonado at H.C. Wainwright. Please go ahead, Andres.

Operator: Thanks for the questions, Daina. Our next question comes from Andres Maldonado at H.C. Wainwright. Please go ahead, Andres.

Andres Maldonado: Hi, everyone. Congrats on the progress and thanks for taking my questions. Just to put everything together, I think pieces of this question have been answered, but thus far, since you've screened over 700 assets, but very few advance in that algorithm. Can you talk to date what commonly kills the opportunity thus far in the screening? Has it been just pure biology, clinical translatability, some of the economics you spoke to? I guess if you take a snapshot of the funnel that you guys use to screen some of these compounds, it would be great to get a sense of some of the puts and takes of the algorithm here. More importantly, Dr. Gupta, how you've maybe advanced that funnel or changed that funnel since you've been at the company.

Speaker #4: Hi everyone. Congrats on the progress, and thanks for taking my questions. Just to put everything together—I think pieces of this question have been answered—but thus far, since you've screened over the 700 assets and very few advance in that algorithm, can you talk to date about what commonly kills the opportunity thus far in the screening?

Speaker #4: Has it been just pure biology, clinical translatability, some of the economics you spoke to? I guess if you take a snapshot of the funnel that you guys use to screen some of these compounds, it would be great to get a sense of some of the puts and takes of the algorithm here, and more importantly, Dr. Pupta, how you've maybe advanced that funnel or changed that funnel since you've been at the company.

Speaker #2: Thank you, Andres, for the question, and thank you also for joining. It's a really good question, and I think as we've evolved our executive team, we're also signaling the types of things that matter as we do asset screening.

Srishti Gupta: Thank you, Andres, for the question, and thank you also for joining. It's a really good question, and I think as we've evolved our executive team, we're sort of also signaling the types of things that matter as we do asset screening. I think two areas that really jump out to me in our asset screening is moving away from what would be sort of an economically, financially driven, almost a fund model of trying to see how do you underwrite an early asset and figure out how to generate financial value from it, to being able to say we're really with high conviction that we're bringing in something that has the potential to really have positive patient impact.

Speaker #2: So, I think two areas that really jump out to me in our asset screening are, first, moving away from what would be a sort of economically, financially driven, almost a fund model of trying to see how you underwrite an early asset and figure out how to generate financial value from it—toward being able to say we really have high conviction that we're bringing in something that has the potential to really have positive patient impact.

Speaker #2: So, the two areas that I think we've been seeing some of the most, sort of, discerning parts of our BD evaluations evolve in the last months have been around clinical development programs.

Srishti Gupta: The two areas that I think we've been seeing some of the most sort of discerning parts of our BD evaluations evolve in the last months have been around clinical development programs. So what does it take to get to a next value inflection point? How do we get there? Which regulator? How strongly do we believe in this? Not off the existing data per se, but actually as we think about having to evolve that data to generate the totality of data that we would use for its registration, and what kind of investment does it take to get to that level of data? We see a lot of signal, sometimes some early PoC data from Phase IIa, but what would it take to actually generate that at scale? How do we advance that?

Speaker #2: So, what does it take to get to the next value inflection point? How do we get there? Which regulator is involved? How strongly do we believe in this?

Speaker #2: Not off the existing data per se, but actually, as we think about having to evolve that data—to generate the totality of data that we would use for its registration.

Speaker #2: And what kind of investment does it take to get to that level of data? So, we see a lot of signal sometimes from early POC data from Phase 2a, but what would it take to actually generate that at scale?

Speaker #2: How do we advance that? And then, where do we think the next value inflection point is? We could either get a strategic partner to be excited about it, or a financial partner to come in and help us continue to advance that.

Srishti Gupta: Where do we think the next value inflection point we could either get a strategic partner to be excited about or a financial partner to come in and help us continue to advance that? Or where do we have our own conviction that we see enough of the value in the data to move the program forward ourselves? I think the second area that I've seen most of the discerning sort of criteria come in in the BD team has been with commercial. Several months before I joined, we hired Mark Hagler as a Chief Commercial Officer to the point that we really need to see a pathway for getting these potential therapies to patients. How do we navigate the health systems in the markets that we're really most excited about for these potential therapeutics to get them to patients?

Speaker #2: Or where do we have our own conviction that we see enough of the value in the data to move the program forward ourselves? I think the second area where I've seen most of the discerning sort of criteria come in from the BD team has been with commercial.

Speaker #2: So, several months before I joined, we hired Mark Hegler as chief commercial officer, and we got to the point that we really need to see a pathway for getting these potential therapies to patients.

Speaker #2: And how do we navigate the health systems in the markets that we're really most excited about for these potential therapeutics, to get them to patients?

Speaker #2: And what does that mean, in terms of where does it differentiate for the physician in the clinic, for the payers? What kind of pathway do we think we would have to take in terms of prior authorization?

Srishti Gupta: What does that mean in terms of where does it differentiate for the physician in the clinic, for the payers? What kind of pathway do we think we would have to take in terms of prior authorization? How many barriers do we think we are navigating to go outside the standard of care or the sort of norm in terms of the payer landscape to get this potential therapeutic to patients? If we do not think that the label that we could generate will be differentiated, could we generate additional data that actually could be there that we could use with payers and with physicians through MSLs? If we do not see that path very clearly, I think that is another reason that we sometimes kind of move away from an asset.

Speaker #2: How many barriers do we think we're navigating to go outside the standard of care or the sort of norm, in terms of the payer landscape, to get this potential therapeutic to patients?

Speaker #2: And if we don't think that the label that we could generate will be differentiated, could we generate additional data that actually could be there, that we could use with payers and with physicians through MSLs?

Speaker #2: And if we don't see that path very clearly, I think that's another reason that we sometimes kind of move away from an asset.

Speaker #4: Great. No, that's very helpful. And maybe a follow-up. So using VSARA as kind of the model for the first installation of the hub and spoke, kind of infrastructure, so VSARA is, I guess, majority owned today, but have you discussed financing it separately and ultimately how should investors think about a subsidiary level dilution versus maybe the amount of this one-to-one economics that you guys ultimately retained?

Andres Maldonado: Great. No, that is very helpful. Maybe a follow-up. Using Visara as the model for the first installation of the hub and spoke kind of infrastructure. Visara is, I guess, majority-owned today, but have you discussed financing it separately? Ultimately, how should investors think about a subsidiary-level dilution versus maybe the amount of this 101 economics that you guys ultimately retained? How correlative is this first spoke story to the other onboarding assets as a kind of a bellwether to what to expect?

Speaker #4: I mean, how correlative is this first Spoke story to the other onboarding assets, as a kind of bellwether to what to expect?

Speaker #2: Thanks for that question. I'll also let Jeff jump in on that one, but before Jeff jumps in, I think for us, we don't think there's a prescribed pathway that fits every single potential therapeutic.

Srishti Gupta: Thanks for that question. I will also let Jeff jump in on that one. Before Jeff jumps in, I think for us, we do not think there is a prescribed pathway that fits every single potential therapeutic. In the Visara case, we followed a pathway because we also share that asset. We are a major shareholder of this subsidiary, but we also have others in there, including the originator with Affimed. We are trying to follow the best pathway for it. In terms of the economics for us versus for our shareholders, right now, we are majority shareholders, and we want to continue to bring in others to advance the program. It has to go through a phase II-B, which is being conducted with our partner, Everest. Eventually, the phase III program will be designed and to carry forward.

Speaker #2: And so, in the VSARA case, we followed a pathway because we also share that asset. We're a major shareholder of the subsidiary, but we also have others in there, including the originator with Affimed.

Speaker #2: And so we're trying to follow the best pathway for it. In terms of the economics for us versus for our shareholders, right now we're majority shareholders, and we want to continue to bring in others to advance the program.

Speaker #2: It has to go through a Phase 2B, which is being conducted with our partner Everest, but eventually the Phase 3 program will be designed to carry forward.

Speaker #2: We don't know if this looks like a crossover into an IPO, which could very much be an option for a company like VSARA.

Srishti Gupta: We do not know if this looks like a crossover into an IPO, which could be very much an option for a company like Visara. We have been talking about expanding that portfolio into other assets, so it very much has the characteristics of becoming a standalone ophthalmology company. As well, there is the differentiation that as it becomes more clear in the phase II-B, I think we are open to the optionality that a strategic partner may be interested in the asset at that stage. So what we have is maximum flexibility, and we are trying to design around where we think the asset has multiple potential paths for exit. Jeff, do you want to add anything? Then maybe Kyler, if there is anything to add. Jeff, do you want to talk a little bit about how you are thinking about building out Visara and

Speaker #2: We have been talking about expanding that portfolio into other assets. So, it very much has the characteristics of becoming a standalone ophthalmology company. But as well, there is the differentiation that, as it becomes more clear in the Phase 2B, I think we're open to the optionality that a strategic partner may be interested at that, and the asset at that stage.

Speaker #2: So, what we have is maximum flexibility, and we're trying to design around where we think the asset has multiple potential paths for exit. Jeff, do you want to add anything? And then maybe Kyler, if there's anything to add, but Jeff, do you want to talk a little bit about how you're thinking about building out VSARA and—

Speaker #3: Yeah, sure. I think the maximum flexibility comment is appropriate. There are a number of options for taking the company forward, but as you can imagine, retina assets are not cheap.

Jeff Nau: Yeah, sure. I think the maximum flexibility comment is appropriate. There is a number of options for taking the company forward, but as you can imagine, retina assets are not cheap. It does take cash to develop those as we move forward. What I would say is the Visara team, once built here and bringing that ophthalmology expertise, has been able to partner well with NovaBridge on the BD and search side of things. We are looking at other assets to continue to build out Visara into what I think will ultimately be a mid-stage pharma company. From the standpoint of, to answer your question, will there ultimately be dilution? It is quite possible at some point in time we would need to raise cash, and NovaBridge has the option to invest or not.

Speaker #3: It does take cash to develop those as we move forward. What I would say is the VSARA team, once built here and bringing that ophthalmology expertise, has been able to partner well with NovaBridge on the BD and search side of things.

Speaker #3: And so, we are looking at other assets to continue to build out VSARA into what I think will ultimately be a mid-stage pharma company.

Speaker #3: So from the standpoint of, to answer your question, will there ultimately be dilution? It's quite possible at some point in time. We would need to raise cash, and NovaBridge has the option to invest or not.

Speaker #3: What I would say, though, is that we plan on developing and creating a company that will far outpace that dilution from the standpoint of value to the shareholder.

Jeff Nau: What I would say, though, is we plan on developing and creating a company that will far outpace that dilution from the standpoint of value to the shareholder. So, I am excited about what we are building here. I think once we sort of unveil everything that we are working on, you will be able to see the full scope. But the power of the ophthalmology expertise with Visara and then the BD search and evaluation expertise with NovaBridge, I think will come to fruition once you see everything that we are building.

Speaker #3: I'm excited about what we're building here. I think once we unveil everything we're working on, you'll be able to see the full scope.

Speaker #3: But the power of the ophthalmology expertise with VSARA, and then the BD search and evaluation expertise with NovaBridge, I think, will come to fruition once you see everything that we're building.

Speaker #4: Great. And if I may, I'll sneak in one quick question on Judith Stomic. In the context of the prior FDA interactions, and the guidance they've given you in terms of perhaps some broad efficacy measurements, does that also apply to the PD-1 low cohort and low populations? And ultimately, what efficacy would you need to see before committing to the pivotal development for that group?

Andres Maldonado: Great. If I may, I will sneak in one quick question on givastomig. In the context of the prior FDA interactions and the guidance they have given you in terms of perhaps some broad efficacy measurements, does that also apply to the PD-1 low CLDN low populations? Ultimately, what efficacy would you need to see before committing to the pivotal development for that group?

Srishti Gupta: Phil, maybe this is a great place for you to jump in.

Speaker #2: Phil, maybe this is a great place for you to jump in.

Speaker #1: Sure. Thanks, Christy. So, Andreas, great question. Our FDA interactions were focused on the PD-L1 positive population, for which the three checkpoint inhibitors in the US have an indication.

Phil Dennis: Sure. Thanks, Srishti. Andres, great question. Our FDA interactions were focused on the PD-L1 positive population, for which the three checkpoint inhibitors in the US have an indication. We have not discussed the PD-L1 less than 1% with them. I think, as you know, we have PD-L1 less than 1% in our ongoing phase I. I think as this data matures, we will be able to make other decisions in terms of life cycle management in that other group of patients, less than 1%.

Speaker #1: So we have not discussed the PD-L1 less than 1%. With them, and I think, as you know, we have PD-L1 less than 1% in our ongoing phase one.

Speaker #1: And I think as this data matures, we'll be able to make other decisions in terms of lifecycle management in that other group of patients, less than 1%.

Speaker #4: Great. Thank you very much.

Andres Maldonado: Great. Thank you very much.

Speaker #2: Thanks for the questions, Andreas. We had a few come in over the webcast. The first one reads as follows: The first-line gastric cancer landscape is becoming increasingly competitive, with multiple CLDN18.2-directed approaches in development.

Operator: Thanks for the questions, Andres. We had a few come over the webcast. The first one reads as follows: The first-line gastric cancer landscape is becoming increasingly competitive, with multiple CLDN 18.2-directed approaches in development. As you think about givastomig strategically, where do you see the opportunity for it to differentiate from existing and emerging therapies, and how is that influencing the development strategy?

Speaker #2: As you think about Givea Stomach, just strategically, where do you see the opportunity for it to differentiate from existing and emerging therapies, and how is that influencing the development strategy?

Speaker #2: Thank you, Tara. Mark, do you want to jump in on this one, and then maybe Phil can add anything?

Srishti Gupta: Thank you, Tara. Mark, do you want to jump on this one?

Mark Hagler: Sure.

Srishti Gupta: And then maybe Phil can add something.

Speaker #3: Absolutely. Thanks, Christy. So, you're absolutely right. CLOTT and 18.2 are clearly becoming important and increasingly competitive targets in first-line gastric. Zolpidoximab has validated both the biology and the commercial opportunity.

Mark Hagler: Absolutely. Thanks, Srishti. You are absolutely right. Claudin 18.2 is clearly becoming an important and is an increasingly competitive target in first-line gastric. Obinutuzumab has validated both the biology and the commercial opportunity, but we believe there is still substantial room for differentiated approaches, specifically those that can reach a broader patient population, integrate easily with the current standard of care backbone, and offer a favorable treatment experience. givastomig was designed as a Claudin 18.2-directed immune amplifying bispecific antibody. Unlike approaches restricted to tumors with high Claudin 18.2 expression, our studies have enrolled patients across a much broader range. In fact, 1-plus staining and as little as 1% of cells. In the data that we have reported publicly to date, we have observed responses across all Claudin 18.2 and PD-L1 expression levels. We are very encouraged by the early efficacy and tolerability of givastomig in combination with nivolumab and FOLFOX.

Speaker #3: But we believe there is still substantial room for differentiated approaches, specifically those that can reach a broader patient population, integrate easily with the current standard of care backbone, and offer a favorable treatment experience.

Speaker #3: Give a stomach was designed as a clot and 18.2 directed immune amplifying bispecific antibody and unlike approaches restricted to tumors with high clot and 18.2 expression, our studies have enrolled patients across a much broader range.

Speaker #3: In fact, one plus staining and as little as 1% of cells in the data that we've reported publicly to date, we've observed responses across all clot and 18.2 and PD-L1 expression levels.

Speaker #3: And we're very encouraged by the early efficacy and tolerability of GivaStomach in combination with Nivo and FOLFOX. Again, publicly we've noted that at the 8 mg per TIG dose, the combination produces a 75% ORR, notably with tumor reduction in 51 of 52 available patients and a preliminary median PFS of 16.9 months.

Mark Hagler: Again, publicly, we have noted that at the 8 migs per tig dose, the combination produces a 75% ORR, notably with tumor reduction in 51 of 52 evaluable patients, and a preliminary median PFS of 16.9 months. Now, these are single-arm data and obviously require randomized confirmation, but the depth and consistency of tumor control, we believe provides a strong rationale for frontline development. Another potential differentiator is practicality. I am a big believer in this in terms of lowering the barriers to commercial adoption. givastomig is being developed directly on top of the established standard of care. It is a simple hang-and-go infusion. There is no dose titration required, no mandated 2-hour post-infusion observation period. So chair time will be very predictable. There will be certainly less nursing operational burden. So the adoption in high-volume clinics, we believe will be substantial. So those are the attributes that are shaping our development strategy.

Speaker #3: Now, these are single-arm data and obviously require randomized confirmation. But the depth and consistency of tumor control, we believe, provide a strong rationale for frontline development.

Speaker #3: Another potential differentiator is practicality. I'm a big believer in this. In terms of lowering the barriers to commercial adoption, Give a Stomach is being developed directly on top of the established standard of care.

Speaker #3: It's a simple hang-and-go infusion. There's no dose titration required, and no mandated two-hour post-infusion observation period. So, chair time will be very predictable.

Speaker #3: There will certainly be less nursing operational burden. So, the adoption in high-volume clinics, we believe, will be substantial. Those are the attributes that are shaping our development strategy.

Speaker #3: I'll let Phil talk a little bit about that in a second. But our goal is to establish a broadly speaking, to establish whether Give a stomach can deliver meaningful benefit across a broad clot and 18.2 positive population while preserving the tolerability and usability required in a first-line setting.

Mark Hagler: I will let Phil talk a little bit about that in a second. Our goal is, broadly speaking, to establish whether givastomig can deliver meaningful benefit across a broad Claudin 18.2 positive population while preserving the tolerability and usability required in a first-line setting. As I mentioned earlier, there are a lot of modalities being developed against the Claudin 18.2 target, including ADCs, T-cell engagers, cell therapies, and those will all ultimately probably play an important role. But payload tox, cytokine release syndrome, step-up dosing, logistical complexity, those ultimately will likely affect where they fit in the treatment sequence. Phil, do you want to add to that?

Speaker #3: As I mentioned earlier, there are a lot of modalities being developed against the CLDN18.2 target, including ADCs, T-cell engagers, and cell therapies. All of these will ultimately probably play an important role.

Speaker #3: But payload tox, cytokine release syndrome, step-up dosing, and logistical complexity—those ultimately will likely affect where they fit in the treatment sequence. So, Phil, do you want to add to that?

Speaker #1: Yeah, let me add one component, Mark, which is that I have a pretty extensive history in late-stage development and big pharma, and lots of regulatory interactions.

Phil Dennis: Yeah, let me add one component, Mark, which is I have a pretty extensive history in late-stage development in big pharma and lots of regulatory interactions. I think what differentiates givastomig and givastomig's development is the depth of regulatory input that we have received to not only define paths for accelerated approval, but also really giving us very clear criteria on what does clinically meaningful look like. This has allowed us to design a very lean study that as we project into the future, I think personally, that we are commercially very competitive in terms of when our study would read out with competitors. I think that's another key thing is the depth and quality of our regulatory interactions.

Speaker #1: And I think what differentiates Giva and Giva's development is the depth of regulatory input that we have received to not only define paths for accelerated approval, but also really giving us very clear criteria on what clinically meaningful looks like.

Speaker #1: And this has allowed us to design a very lean study that, as we project into the future, I think personally we are commercially very competitive in terms of when our study would read out compared with competitors.

Speaker #1: So, I think that's another key thing: the depth and quality of our regulatory interactions.

Speaker #2: Great, thank you. This concludes today's Q&A session. I will now turn it back to Christy for closing remarks.

Operator: Great. Thank you. This concludes today's Q&A session. I will now turn it back to Srishti for closing remarks.

Speaker #5: Thank you, Tara. Thank you, everyone, for joining. As I said earlier, I know we're in the early days of our broader strategy. We're very committed to not just describing our model well, but more importantly, to moving forward on the execution of our programs for Give a Stomach.

Srishti Gupta: Thank you, Tara. Thank you, everyone, for joining. As I said earlier, I know we're early days on our broader strategy. We're very committed to not just describing our model well, but more importantly, moving forward on the execution of our programs for givastomig, the advancing of our data set, and the building of our portfolio in Visara, and making sure that we can show that we are able to build out in our next areas. Please stay tuned. We're looking forward to meeting many investors as we are on the fall investor circuit. As always, please reach out to our team if you want to set up time. Thank you again for joining.

Speaker #5: The advancing of our data set and the building of our portfolio in VISARA, and making sure that we can show that we are able to build out in our next areas.

Speaker #5: So, please stay tuned. We're looking forward to meeting many investors as we participate in the fall investor circuit. As always, please reach out to our team if you would like to set up a time.

Browse all earnings call transcripts

Half Year 2026 NovaBridge Biosciences Earnings Call

Request TrialDemo

NovaBridge

Earnings