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Good morning, and welcome to the NovaBridge Biosciences first half 2026 corporate update and financial results call. At this time, all attendees are in a 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 U.S. 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 December 31, 2025, and any other filings that are or may be made with the SEC. 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. 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.

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 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. 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. 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. 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. 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.

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. 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 Ib 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 first half of 2026, we reported updated phase Ib results, initiated our global randomized phase II study, and made important regulatory progress. 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 Ib 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 fourth quarter of this year. Next slide, please.

Let me now turn to why we're excited about givastomig. 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 Ib study, we observed encouraging response rates, disease control, and progression-free survival across the combination cohorts. Second, there's 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 the broader patient population. And 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.

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 believed 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. 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 second half of this year with the goal of further defining the optimal dose and advancing the program towards global phase III development. 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 first-half financial results.

Thank you, Srishti, and good morning, good evening, everyone. Next slide, please. As of June 30, 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.

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 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.

Thank you, Kyler. Next slide, please. I want to highlight the catalysts 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 Ib 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 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. For VIS-101, we're preparing to initiate the Phase IIb program in the second half of 2026 and continue advancing the program towards global phase III development.

As I reflect on the first half of 2026, what excites me the most is not only the progress of givastomig and VIS-101, but what those programs represent. 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. 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.

Great. Thank you, Srishti. At this time, we'll 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 poll for questions. Our first question comes from Daina Graybosch at Leerink Partners. Please go ahead.

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 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 givastomig, a highly innovated IO asset in Visara. Thank you.

Thank you, Daina, for the question. I just wanted to let everyone know that in addition to Kyler and myself, I'm joined by Mark Hagler, our Chief Commercial Officer, Dr. Phil Dennis, our Chief Medical Officer, and Jeff Nau, the CEO of Visara. So in case there's questions, we have our executive team here today. Daina, on your question, I'll start and I'd love to turn it over to Mark as well. But I think as we think about our future growth platforms, for us, it's really the combination of the capabilities of having both the business development as well as the internal clinical development. 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. You asked specifically about European gaps. We're 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. We haven't quite identified which parts of the therapeutic area we would like to combine our efforts on.

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. 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.

Sure. Thanks very much, Srishti. I'll speak a little bit about the unmet need in Europe as well. I think 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 U.S. and not file in the E.U. So there's certainly opportunity there from our perspective. Srishti?

Thank you, Mark. Daina, just to 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/ability yet to invest in large scale BD functions in this part of the innovation landscape. So 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.

Maybe to move on to the women's health question, 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-specific disease areas. For example, endometriosis or menopause or polycystic 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 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. 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? How do we think about what used to be called polycystic ovarian syndrome, now PCOS? Those are types of areas that we're thinking about, as well as osteoporosis, osteopenia, and sarcopenia, which are disproportionately affecting women. We're looking at a range of mechanisms of action and we're trying to think about how we would advance those MOAs towards potential therapeutics. Any follow on, Daina, before we take another question?

Maybe just to confirm the Europe point. Because of your unique BD capabilities in China, this is really a fast follower, so a U.S. or global company focused on the U.S. 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?

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. 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. 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.

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 been advanced for innovation with a regulatory pathway that is 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. 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.

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?

I think what we're seeing a couple things. Recently, Menarini Group 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-1 usage into the national health systems at scale has not sort of consistently been done. I'm guessing as Menarini Group 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, just living in Europe myself, that PCSK9 inhibitors are not nationally reimbursed in many contexts over statins. 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. 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. 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.

Can we do more in other areas? But that's a little bit around how we're thinking about the type of step-up that we want to bring to patients regardless of what geography they're in.

Okay. Thank you.

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

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, 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, and more importantly, Dr. Gupta, how you've maybe advanced that funnel or changed that funnel since you've been at the company.

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 have high conviction that we're bringing in something that has the potential to really have positive patient impact.

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 from early PoC data from phase IIa, but what would it take to actually generate that at scale?

How do we advance that? 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 ourself? 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.

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? 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'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? 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?

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.

Great. No, that is very helpful. And 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, majorly owned today, but have you discussed financing it separately? Ultimately, how should investors think about a subsidiary-level dilution versus maybe the amount of VIS-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?

Thanks for that question. I will also let Jeff jump in on that one. But 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 as 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 IIb, which is being conducted with our partner, Everest.

Eventually the phase III program will be designed and to carry forward. 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 IIb, 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.

But Jeff, do you want to talk a little bit about how you are thinking about building out Visara?

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.

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. I am excited about what we are building here. I think once we 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.

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 Claudin-low populations? Ultimately, what efficacy would you need to see before committing to the pivotal development for that group?

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

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 U.S. 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, and 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%.

Great. Thank you very much.

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 CLDN18.2-directed approaches in development. As you think about givastomig 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?

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

Sure.

Maybe Phil can add anything.

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. zolbetuximab 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, and unlike approaches restricted to tumors with high Claudin 18.2 expression, our studies have enrolled patients across a much broader range. In fact, one 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 nivo and FOLFOX. Again, publicly, we have noted that at the 8 mg per kg 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. 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 two-hour post-infusion observation period. 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. Those are the attributes that are shaping our development strategy. 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?

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 is another key thing, is the depth and quality of our regulatory interactions.

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

Thank you, Tara. Thank you everyone for joining. As I said earlier, I know we're early days in 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.

Greetings. Welcome to I-MAB Biopharma’s first half 2024 financial results and corporate update conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If you would like to ask a question, please press star, one on your telephone keypad and a confirmation tone will indicate your line is in the question queue. You may press star, two if you’d like to withdraw your question from the queue. For participants that are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Also, if anyone should require Operator assistance during the conference, please press star, zero from your telephone keypad. Please note that this conference is being recorded. I’ll now hand the call over to Tyler Ehler, Vice President of Investor Relations. Tyler, you may now begin your presentation.

Thank you Operator, and welcome everyone to I-MAB Biopharma’s first half 2024 financial results and corporate update conference call. This morning, I-MAB issued a press release reporting its first half 2024 financial results and corporate update. To access a copy of the press release, please visit the Investor Relations page of the company’s website. Before we begin, I would like to remind everyone that statements made during this conference call will include forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, which involves risks and uncertainties that can cause actual results to differ materially. Forward-looking statements speak only as of the date they are made as the underlying facts and circumstances may change. Except as required by law, I-MAB undertakes no obligation to update these forward-looking statements to reflect future information, events or circumstances. This presentation includes statistical and other industry and market data that we obtain from industry publications and research surveys and studies conducted by third parties, as well as our own estimates of potential market opportunities. All of the market data used in this presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our estimates of the potential market opportunities for our product candidates include several key assumptions based on our industry knowledge, industry publications, third party research and other surveys, which may be based on a small sample size and may fail to accurately reflect market opportunities. While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions. For more information on forward-looking statements, please review the disclaimers in today’s press release and the risk factors in the company’s SEC filings. With that, I will now turn the call over to Dr. Sean Fu, I-MAB’s interim Chief Executive Officer and Board director.

Thanks Tyler, and thanks to everyone for joining us today. So far this year, 2024 has been transformational for I-MAB thanks to the excellent contributions by everyone in our organization. We are executing on the Board’s vision and delivering on our strategic plan. I’m excited about our continued progress as demonstrated by significant corporate and pipeline developments. For this morning’s call, I will make a few opening remarks regarding our strategic milestones, organization and pipeline. After that, Dr. Phillip Dennis, our Chief Medical Officer will provide an update on our three differentiated immuno-oncology therapeutic programs with upcoming milestones, and next Joe Skelton, our Chief Financial Officer will run through a few key financial items, including a review of our cash balance and runway. I’ll wrap up with a few closing remarks, then we’ll open the call for questions. I joined I-MAB as a Board director and interim CEO about a month ago. As I become more familiar with the organization, I’m more enthusiastic about I-MAB and all the team has accomplished so far this year. Furthermore, I believe the combination of our differentiated pipeline, experienced leadership team, and strong cash position will allow us to make meaningful progress in the second half of 2024 and beyond. I’d like to share some of our notable accomplishments from the first half of this year. First, with the divestiture of operations in China announced earlier this year on April 2, we established a new operating model as a U.S.-based global biotech company. As part of the transaction, we also extinguished $183 million of redemption obligations. Subsequent to the second quarter, we extinguished an additional $17 million of redemption obligation. We have efficiently worked to streamline our organization and to build a new U.S.-based leadership team which includes the addition of Joe as CFO and Phillip as CMO. From a corporate governance perspective, we successfully transitioned to have PWCUS as our corporate auditor. As you will hear from Phillip, we have significantly advanced our three oncology programs. We are squarely focused on execution and believe we are well positioned to make additional progress through the end of this year and beyond. As we look forward, we continue to think strategically and with an open mind to evaluate the new opportunities that could further enhance our pipeline. Moving to Slide 5, establishing an experienced U.S.-based management team is critical to I-MAB’s long term success. Our diverse leadership team has experiences in many areas, including: conceiving and implementing strategic plans for asset development; deep scientific know-how in developing early stage targeted therapies for cancer, with a focus on immuno-oncology; and identifying and completing strategic transactions, raising capital and building successful organizations. In my experience, these are some of the core competencies for successful biopharma companies today. Our leadership team exemplifies these core competencies. Our collective professional experiences and stellar track record is one of I-MAB’s most important strategic competitive advantages. I’m pleased to introduce you to the I-MAB leadership team, including our new CMO, Phillip Dennis. Phillip is a renowned lung cancer expert with broad clinical development expertise across a range of therapeutic modalities, with over 10 years within big pharma focused on immuno-oncology, antibody conjugates and targeted therapies. Our CFO, Joe Skelton is an experienced investment banker with a track record of successfully executing numerous transactions for biotech and biopharma companies throughout his career. Our Vice President of Clinical Development, Claire Xu brings significant clinical execution experience running oncology clinical trials and has been a core part of I-MAB’s historical U.S. operations, having been at I-MAB for almost seven years. I’m impressed by the team’s deep understanding of our clinical programs and their sincere dedication to strategically advancing our pipeline in the best way possible. Moving to Slide 6, our pipeline includes three oncology programs focused on providing meaningful therapeutic options to cancer patients with significant unmet medical needs. All of these assets are commercially attractive, supported by co-development and a clinical supply agreement with Bristol Myers Squibb, TJ Bio and ABL Bio. Our lead program, uliledlimab, is an antibody that targets CD73. We are developing it for the treatment of metastatic non-small cell lung cancer and expect to initiate a frontline combination study in the first half of 2025. Meanwhile, TJ Bio, our collaborator expects to read out randomized Phase II PFS data combining uli and toripalimab in the second half of 2025. Our second program, givastomig, is a bispecific antibody that targets Claudin 18.2-positive tumor cells, which conditionally activates T-cells via 4-1BB where Claudin 18.2 is expressed. We are developing givastomig for the treatment of first line gastric cancers as an add-on to the current standard of care. We expect to present updated data from our Phase I monotherapy dose expansion study at the European Society for Medical Oncology, or ESMO 2024 meeting in September. Our third program, ragistomig, is a bispecific antibody designed to provide anti-PDL1 and a 4-1BB driven T-cell activation. It has been developed for cancers that are relapsed or refractory to checkpoint inhibitors and recently presented compelling early data at ASCO 2024. I’m optimistic about our portfolio with our early clinical data, and our innovative clinical trial strategies and the strong team driving these programs forward offers us the potential to achieve important clinical milestones over the next year and beyond. With that, I would like to turn the call over to Dr. Phillip Dennis, I-MAB’s Chief Medical Officer. Phillip?

Thank you Sean, and good morning everyone. Over the next few minutes, I will review the recent progress and upcoming milestones of our clinical pipeline, starting with uliledlimab, or uli for short. Slide 7 begins the section on uli. Uli targets CD73, which is the rate-limiting enzyme critical for converting AMP, or adenosine monophosphate into the immunosuppressive metabolite, adenosine. Blocking CD73 allows anti-tumor immunity to proceed in the tumor microenvironment without the presence of an adenosine-induced immunological fog. We believe uli is differentiated given its superior pharmacokinetic properties versus other competitors, as demonstrated by its ability to completely inhibit CD73 activity without the hook effect that has been described for other drugs that target CD73 and may prevent them from achieving maximal inhibition of CD73. The illustrations on Slide 8 were created to show uli’s mechanism of action and how uli is differentiated from other CD73 antibodies. CD73 is activated when it is in a closed confirmation. We believe that uli’s differentiation comes from its ability to bind to the C-terminus of the enzyme to prevent the formation of the closed dimer. CD73 is a butterfly structure. It has two end termini and two C termini. Because one molecule of uli binds to two adjacent CD73 dimers on the C-terminus, it doesn’t exhibit the hook effect. In fact, our preclinical studies show that this approach completely inhibits CD73 in a dose-dependent manner. In contrast when looking at other compounds such as oleclumab, which binds to the end terminus of CD73, what can happen is that as concentrations of drug increase, the intermolecular bonds needed to inhibit 73 activity are harder to form because the antibodies bind to the end terminal binding sites with single valency, therefore intermolecular bonds are not formed as readily at high concentrations as at lower concentrations and inhibition of CD73 is paradoxically less at higher concentrations than at lower concentrations. This is not observed with uli in preclinical model systems. During this call, I will walk you through the three studies from the uli program. The first study is outlined on Slide 9. Data from this study presented at ASCO 2023 show that patients who had CD73 expression and a PD-L1 TPS score of greater than or equal to 1% experienced an objective response rate, or ORR of 63%. Patients with lower levels of CD73 expression had a lower ORR. The ORR in the CD73 high group is higher than that observed in Keynote 42, which tested pembrolizumab monotherapy in the same disease setting and with the same distribution of PD-L1 expression. These data suggest that tumors with high levels of CD73 expression will respond best to uli. In addition to providing important proof of concept data, the study also shows that the combination was well tolerated. Two-thirds of metastatic non-small cell lung cancer patients have tumors that express PD-L1 in less than 50% of cells. For them, the standard of care is a checkpoint inhibitor, or IO combined with chemotherapy. On Slide 10, we outline the clinical rationale for a combination study that will include uli plus IO plus chemotherapy. First, the addition of chemotherapy to IO monotherapy has extended the benefit of IO to patients whose tumors express low levels of PD-L1. Second, uli has a favorable toxicity profile that suggests that the four-drug combination could be tolerated. Third, published data show that chemotherapy can induce CD73 expression which could increase the likelihood of response to uli. Ultimately, non-small cell lung cancer is one of the most common and deadly cancer diagnoses globally and we believe that uli has the potential to improve upon currently available standard of care, whether that standard of care is IO monotherapy or IO plus chemotherapy. I-MAB has received FDA clearance to proceed with the study of uli plus pembro plus chemotherapy, and we expect to dose the first patient in the first half of 2025. In the previous slide, we laid out the rationale for the four-drug combination study. This is an important study because we believe it could help define the regulatory path for uli in the future. We intend to enroll patients who are eligible for first-line treatment of locally advanced or metastatic non-small cell lung cancer. The study is randomized against IO plus chemo standard of care and is designed to evaluate two different uli dose levels. Importantly, CD73 expression will be assessed retrospectively. The primary endpoint is objective response rate with standard secondary endpoints of progression-free survival, duration of response, and overall survival all stratified by PD-L1 expression. This study includes a small dose escalation lead-in with an N=6. Dosing is expected to begin in the first half of 2025. Once safety is assessed in the lead-in, patients will be randomized in a two-to-one ratio against standard of care, assessing uli with two different dose levels. In this slide, we believe it’s important to share not only uli’s upcoming milestones but the adenosine pathway as a whole, given its promise in the immuno-oncology space. We have prepared this chart to put the upcoming clinical milestones for uli into context with other CD73 programs. On the top of the chart, we have summarized three milestones for the ongoing and planned studies in our program, including the first patient dosed in the randomized Phase II study of uli plus pembro plus chemo I just described. We expect to be able to provide a read-out from this study in the second half of 2026. Additionally, we highlight upcoming progression-free survival, or PFS data from the uli plus toripalimab randomized Phase II study ongoing in China only in the second half of 2025. This study is being conducted by our collaborator in China, TJ Bio, who holds the right to uli in China. On the bottom of the chart, we summarize expected Phase I/II milestones for four other CD73 programs. We believe the positive results from other programs will help further validate the adenosine pathway, specifically CD73 as a target, and that our approach for patient selection using CD73 expression as well as uli’s ability to completely inhibit CD73 could represent a differentiated advantage. Next I’d like to turn givastomig on Slide 13. Givastomig, or giva is a bispecific antibody that is designed to target Claudin 18.2, a tumor-associated antigen found on solid tumors, especially gastric cancers. The bispecific antibody combines with Claudin 18.2 binding domain, where Claudin 18.2 is expressed, and 4-1BB which conditionally activates T-cells in the tumor microenvironment. Moreover, we believe giva is differentiated by its ability to bind to Claudin 18.2 even in tumors with very low levels of 18.2 expression. Slide 14 provides an opportunity to highlight giva’s bispecific design properties and the monotherapy data that may position it as a best-in-class Claudin 18.2 4-1BB biospecific antibody. Initial Phase I monotherapy data reported at the ESMO 2023 meeting showed encouraging monotherapy results in patients with gastric cancers whose tumors had progressed or were refractory, including those with low levels of Claudin 18.2 expression. Based on the data from the Phase I monotherapy results, we initiated a combination study of giva plus nivolumab plus chemotherapy in the first half of 2024. Bristol Myers Squibb is supplying nivolumab under a clinical collaboration and supply agreement. Top line data from the study are expected to read out in the second half of 2025. In the meantime, I-MAB plans to present new top line data from the Phase I monotherapy dose expansion study in patients with gastric cancers whose disease has progressed after previous treatment at ESMO 2024. Moving to Slide 15, investors often ask about other Claudin 18.2 programs in development and how giva compares to zolbetuximab, or zolbe. In response, we have prepared this comparative slide. On the left side of the chart, we have summarized several parameters from the giva Phase I monotherapy data presented at ESMO 2023 related to Claudin 18.2 expression and clinical outcomes. On the right-hand columns, we summarize published Phase I data and Phase II data from zolbe. While the table does not represent data from a head-to-head study, I believe it highlights the strength of potential differentiation of giva. This data highlights giva’s ability to treat patients even with low levels of Claudin 18.2 expression. For example, zolbe did not show a response in its Phase I study when Claudin 18.2 was expressed at 1+ or greater in at least 1% of cells. When Claudin 18.2 parameters were tightened to 2+ or greater staining in 50% of cells, zolbe monotherapy results appeared inferior to giva monotherapy results. These data support our view that giva has best-in-class potential and could be combined with frontline standard of care nivo plus chemo in gastric cancer. Lastly, I’d like to turn to ragistomig on Slide 16. Ragistomig, or ragi is a bispecific antibody in development to treat advanced solid tumors that are refractory to checkpoint inhibitors. The bispecific antibody was designed to provide anti PD-L1 activity and 4-1BB driven T-cell activation in a single molecule using the same 4-1BB technology design as giva. The combination of an FC-silent antibody with condition 4-1BB engagement is intended to optimize the compound for safety, including the potential for lower hepatotoxicity compared to traditional 4-1BB agonists. Localized activation of 4-1BB in the tumor microenvironment is intended to enhance anti-tumor immunity and reinvigorate exhausted T-cells while mitigating liver toxicity and systemic immune responses. Slide 17 provides a snapshot of early Phase I dose escalation and dose expansion data presented at ASCO 2024 by our collaborator, ABL Bio. The study enrolled 53 patients with advanced or relapsed solid tumors, 44 of whom were evaluable at the time of the presentation. The majority of patients had at least three prior lines of treatment. Top line Phase I results demonstrated an ORR of 27%, including six partial responses, one complete response, and a clinical benefit ratio of 69%. Seventy-one percent of patients who responded had received prior checkpoint inhibitors. The complete response was observed in a heavily pre-treated ovarian cancer patient who had received seven prior lines of therapy. We are encouraged by the results from the study because of the early clinical signs of efficacy. Enrolment in selected indications and different dose schedules is ongoing. Slide 18 provides a snapshot of the safety profile. While increased liver enzymes where the most common treatment-emergent adverse event, none of the transanimated salivations were accompanied by increases in bilirubin, the so-called Hy’s Law. Patients with grade 3 increases in liver enzymes improved with corticosteroid treatment and no cytokine release syndrome was reported. The combination of ragi’s early efficacy and manageable safety profile is encouraging, and enrollment in the Phase I study continues. Slide 19 provides a recap of the pipeline. In summary, we are encouraged by the early clinical data for uli, giva and ragi. We believe that each agent has a unique and differentiated mechanism of action and a manageable safety profile. We are excited to be on the cusp of clinical milestones for each program, including an upcoming data release at ESMO 2024 where we will share Phase I dose expansion monotherapy data. Now I will hand the call over to Joe for the financial overview.

Thank you Phillip. As we turn to Slide 20, we are shifting the discussion to corporate development and finance. As we begin, I want to make a note that we are reporting all of our financial results in U.S. dollars. As we begin to talk about the financials, I want to echo Sean’s opening comments that I-MAB has executed on the Board’s vision and made significant strategic and corporate development progress in 2024. I’ll touch briefly on five key corporate parameters that we believe are strategically important for I-MAB. First, we extinguished $200 million of a $215 million redemption obligation. $183 million was extinguished at the time of the divestiture with another $17 million extinguished subsequent to the end of the second quarter. We expect to extinguish the remaining obligations of approximately $15 million in September of this year. Second, we streamlined the pipeline. We are advancing uli into Phase II in the U.S. and are continuing to advance giva through the ongoing Phase Ib. With the divestiture of the China operations, two Phase III trials shifted to TJ Bio, felzartamab and eftansomatropin alfa. Third, we strengthened the giva clinical program through a clinical trial collaboration and supply agreement with Bristol Myers Squibb. BMS is supplying nivolumab for the triple combination study evaluating givastomig in combination with chemotherapy and nivolumab, the standard of care in frontline gastric cancer. Fourth, we optimized the workforce by streamlining from 220 FTEs at year end to 34 at June 30. We’ve also shifted the organization so that the full senior leadership team is based on the U.S. and the workforce is primarily based in the U.S., and lastly we engaged U.S. auditors. Earlier this month, we announced that we had appointed PWCUS as our financial auditors. As we move to Slide 21, I would like to take you through a pro forma cash walk using our last reported cash balance and review our cash runway expectations. Starting with our cash walk on Slide 21 and moving from left to right, you can see our last reported cash balance as of December 31, 2023 was $321.8 million. As of June 30, I-MAB’s reported cash balance was $207.5 million. The delta of $114.3 million is comprised of cash outflows across five major buckets, partially offset by inflows in the second quarter. Item A, $10.8 million of the cash reported at 12/31/2023 remained with the divested I-MAB Shanghai entity to settle working capital obligations and, consistent with ASC 205-20 accounting treatment, was recast to discontinued operations, bringing the comparative year-end cash balance to $311 million. Item B, in the first quarter of 2024, $47.8 million in outflows were incurred related to the divestiture of China operations, including $19 million for our Series C investment in TJ Biopharma, $17.5 million placed into escrow related to arbitration with a dissenting shareholder which has been subsequently settled, foreign exchange losses incurred on the transfer of renminbi to U.S. dollars, and other non-recurring expenditures associated with the divestiture. Item C, during the first quarter, there were $47.1 million in consolidated operating expenses to the I-MAB Group pre-closing of the divestiture. Item B, in the second quarter there were $1.6 million in additional non-recurring expenses incurred associated with the divestiture. Item B, in the second quarter there were $12.1 million in operating expenses of IMAB as a standalone entity. Of note, there were also cash inflows of $5.1 million attributable to the return of a deposit to support the share buyback program, which the company no longer anticipates renewing, and interest income earned during the second quarter of 2024. Looking ahead, we believe that based on our current operating plans, our cash runway will take us into 2027, including several important clinical milestones. Moving to Slide 22, we have provided a summary of selected financial information and upcoming milestones. To recap on the financials, our cash and cash equivalents and short term investments were $207.5 million as of June 30, 2024. We believe based on our current operating plans that our cash runway will take us into 2027, including several clinical milestones. Our issued and outstanding ordinary shares represent an equivalent of 81.4 million ADS. Now I’d like to turn the call back to Sean to wrap up.

Thank you Joe. As we get ready to take your questions, I’d like to summarize the company’s upcoming milestones and make a few closing comments. First, we’ve mapped out four upcoming milestones, two each for giva and uli. For giva, we expect to present updated Phase I dose expansion data at the ESMO 2024 meeting, and we expect to provide top line data from the giva combo study in gastric cancers in the second half of 2025. For uli, we expect to initiate the first patient dose in the combination study in patients with advanced non-small cell lung cancer in the first half of 2025, and we expect to provide top line progression-free survival data from the randomized Phase II study conducted by our collaborator, TJ Bio in the second half of 2025. As we conclude today’s prepared remarks, I’d like to leave you with these key messages. I-MAB is exclusively focused on the development of differentiated immunotherapies for cancer. 2024 has been transformational for I-MAB. With the divestiture of operations in China announced on April 2, we established a new operating model as a U.S.-based global biotech company. Thanks to the excellent contributions by everyone in our organization, we are executing on the Board’s strategic vision. We have significantly advanced our three oncology programs and worked efficiently to streamline our organization, build a new U.S.-based leadership team, and complete key governance and corporate development milestones. As we look forward, we’ll continue to think strategically to evaluate the new opportunities to further enhance our pipeline. We are squarely focused on execution, and we believe the combination of our differentiated pipeline, experienced leadership team and strong cash balance position will let us make meaningful progress in the second half of 2024 and beyond. Now I would like to thank everyone for listening to our call and ask the Operator to please open the call for questions.

Thank you. We’ll now be conducting a question and answer session. [Operator instructions] Thank you, and our first question will be coming from the line of Joe Catanzaro with Piper Sandler. Please proceed with your questions.

Hey everybody, thanks for taking my questions. I maybe had a couple on givastomig, first one on the upcoming ESMO update. Wondering if you could just help set expectations in terms of the data set we’ll see, patient numbers and any new learnings around the monotherapy profile there. Then second question, appreciate the comparison to zolbetuximab, but wondering if you had any thoughts on how giva maybe compares to the growing Claudin 18.2 ADC landscape and where it could differentiate versus those programs. Thanks.

Thank you for your question, Joe. We’ll turn that question over to our Chief Medical--go ahead, Tyler?

I was just going to say, we’ll turn that question over to our Chief Medical Officer, Dr. Phillip Dennis.

Thanks Tyler, and thanks for the question. The data presented at ESMO again will be data from the dose expansion cohorts with gastric cancer. This will be with approximately 30 patients, and the profile is again one of exquisite safety and again a notable ORR. But importantly, I think you raise an important question. The way we envision giva’s development, given its tolerability, is to combine it with frontline therapy with nivolumab and regimens such as Folfox. I think that is the basis for the differentiation with other 18.2-targeted assets. While we know that ADCs, given their toxic payload, can have a notable objective response rate, which again if we compared giva against the ADC that is being developed by AstraZeneca, our ORR is inferior; but arguably, our tox profile is much better suited for combination in frontline studies, and I think that’s the differentiating feature. I think for an ADC targeting 18.2, for movement to frontline therapy, one would have to make accommodations in the standard of care chemotherapy because it simply would be very difficult to tolerate an ADC plus every drug that’s in Folfox, for example, so I think that’s a differentiating feature where we can be more readily combined with frontline therapy.

Okay, great. That’s all helpful. Thanks for taking my questions.

Our next questions come from the line of Kelly Shi with Jefferies. Please proceed with your questions.

Hi, this is [indiscernible] for Kelly Shi. Congrats on the progress in the first half of ’24. I just have two quick questions. First, what is your targeted finish date for the transitioning to the U.S.-based auditor? What should we think about expenses going forward split between the U.S. and China? My second question is for the pipeline strategy, as you’re thinking about expansion to your--adding more assets to your pipeline, are you still focusing on the oncology space or looking to expand to other therapeutic areas? Thank you.

Thank you for your question. Was it possible to repeat the first question, and then we’ll turn the question over to Sean, our interim CEO to answer?

Sure. The first question is what’s your target finish date regarding fully transitioning to a U.S.-based auditor?

Yes, thanks for that question. We have completed the transition, and PWCUS is now our corporate auditor and we’ve been working closely with them since the completion of the transition. This is an important accomplishment. Together with other corporate developments after the divestiture, they started to see the change in, as a company, how I-MAB is allocating resources. The going burn rate - I think that’s part of the question you asked earlier - the going burn rate will be considerably lower compared to what you saw in the first and second quarters of this year, because we have streamlined our organization to focus on clinical development programs going forward. The other question, you asked about the pipeline strategy - yes, we are actively looking to further enhance our pipeline through external collaboration or licensing opportunities, and obviously given that the three assets internally are all oncology focused, our team has significant oncology asset development experience that we are starting our reviews, our explorations in the oncology space, but we are not limiting ourselves just to oncology. For adjacent modalities, we are also open for discussion and collaboration, but oncology is one area we obviously see synergy. I think the final part of the question has to do with going forward, the pipeline strategy. We are squarely focused on execution of our internal pipeline, the three that we explained in detail today by Phillip, and we are excited about this pipeline, so we’re looking to license in and we’re looking for collaboration opportunities from external partners. Important to note that when we think about the BD strategy, we are looking for assets that have the potential to enter or are already in clinical stage, therefore we can expect it to bring a near term value inflection for I-MAB in the next year.

Great, thank you.

Thank you. As a reminder, if you’d like to ask a question, you may press star, one from your telephone keypad. Our next question is from the line of Andres Maldonado with HC Wainwright. Please proceed with your questions.

Hi, thank you. Congratulations on the progress. Thank you for taking my question. Just two quick ones from me. For the uliledlimab combination study, could you talk a little bit about what you need to see on the efficacy front for this new study, and what are some of the external signals you’re using to benchmark your go/no-go decision? Then as an additive question, in the second half the Phase II PFS data from the TJ Bio study, just curious on how you’re going to leverage that data moving forward and what you need to see there. Thank you very much for taking my questions.

Thank you for your question, Andres. I will direct your question to our Chief Medical Officer, Dr. Phillip Dennis. Phillip?

Thanks. I will address the questions in order, and if I don’t do so completely, please make sure I address all of them. In terms of benchmarks for efficacy in our Phase II, the sense is the comparison is Keynote 189, where we know the median PFS is about nine months, and we know the ORR can vary depending on the PD-L1 expression, so basically what we’re looking for is clinically meaningful improvements, incremental improvements that are clinically meaningful over the standard of care, Keynote 189. Moreover, in our proposed Phase II, we’ll be assessing CD73 retrospectively and we will be focused heavily on whether or not the signals that we are seeing are predominantly in that CD73 positive group. Now in terms of external benchmarks, as the slide showed, we’re very interested in outcomes from competitor studies because positive outcomes from these competitor studies will really validate the adenosine pathway, and these studies include studies with oleclumab that is being developed by AstraZeneca in earlier stages of disease, resectable disease, Stage 3 unresectable disease as well as antibodies, again CD39 in small molecules, so we think that this will help again propel the field forward, give us confidence in uli, in the pathway, and I think with the signal that we hope to see from our study, from our proposed study with pembro chemo and with the TJ Bio doublet study, that is in the CD73 selected population, we will get support for our hypothesis that it’s the patients that have high CD73 expression that benefit most from uli.

Great, thank you very much.

Thank you. At this time, we have no additional questions, and I’ll hand the call back to Dr. Sean Fu for closing remarks.

Great. Thank you very much again for taking the time to join our call today. As you can gather from the discussions and the presentations, we’re very excited about the pipeline, and the team is dedicated to continue to push the pipeline forward in the most efficient and scientific way. We look forward to updating you on our future progress, and if you have any follow-up questions, please reach out to Tyler Ehler, our Head of Investor Relations. Have a great day. You may now disconnect the call.

This will conclude today’s conference. Thank you for your participation.

Good morning, everyone, and thank you for joining us this morning and for standing by. I'd like to take this opportunity to welcome you all to the I-Mab Biopharma Mid-Year 2023 Financial Results and Business Update Conference Call. My name is Tyler Ehler, and I'm I-Mab's Senior Director for Investor Relations. At this time, all participants are in a listen-only mode. At end of this call, we will conduct a Q&A session and instructions will follow at that time. Earlier today, we issued a press release providing a review of our financial results for the mid-year ended June 30, 2023, as well as an overview of our recent corporate highlights and upcoming milestones. The press release can be accessed on the Investor Relations tab on our website at ir.i-mabbiopharma.com. Joining me today on the call from I-Mab’s senior management team are Raj Kannan, CEO; Dr. John Hayslip, Chief Medical Officer; Dr. Andrew Zhu, President and Head of R&D; and Richard Yeh, Interim CFO and COO. Raj will provide a high-level overview of our recent achievements and upcoming milestones, and John will provide an update on our R&D progress. Richard will then provide a summary of our financial results for the six months ended June 30, 2023, before we turn the call over to Raj for a few final comments. And then back to the operator to take your questions. Please note that today's discussion will contain forward-looking statements relating to the company's future performance and the forward-looking statements are made under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995. Such statements are not guarantees of future performance and are subject to certain risks and uncertainties, assumptions and other factors. Some of these risks are beyond the company's control and could cause actual results to differ materially from those mentioned in today's press release and on this earnings call. A general discussion of the risk factors that could affect I-Mab's business and financial results is included in certain filings of the company with the Securities and Exchange Commission, including, but not limited to, the Risk Factors section in I-Mab's most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties and other important factors in I-Mab's subsequent filings with the SEC. Moreover, we operate in an evolving environment. New risk factors emerge from time to time, and it's not possible for us to predict all risk factors nor can we assess the impact of all factors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in today's press release and on this earnings call relate only to the events or information as of the date on which the statements are made. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. We'll also discuss specific non-GAAP financial measures during today's call, the presentation of which is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with US GAAP. Please see the financial results press release issued earlier today for a definition of non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial results. And with that, I'll now turn the call over to our CEO, Raj Kannan. Raj, please go ahead.

Thank you, Tyler, and good morning, everyone, and thank you for joining us. It has been an energizing few weeks for me since I came on board as CEO in June. I came to this new role with much confidence in I-Mab’s innovative programs and an understanding that we have a great deal of work ahead of us. Today, I'm pleased to speak with you and set out a clear direction for I-Mab that could potentially unlock the significant inherent value that I see in this company for our shareholders. During our call, I will provide you with a high-level update on our performance in the first half of 2023 and importantly, frame our strategic direction and plan. I will ask John Hayslip, our Chief Medical Officer, to provide you with an update on the two prioritized clinical assets in oncology that we plan to rapidly advance in the US and globally and finally, review the recently released positive Phase 3 results from our lead program in China. Richard Yeh, our Interim Chief Financial Officer, will review the financial results for the first six months of 2023 and then hand it back to me for closing remarks. The first eight months of 2023 have been productive for I-Mab. We made significant progress on our innovative assets, including uliledlimab, our differentiated CD73 antibody, givastomig, our novel Claudin 18.2 and 4-1BB bispecific antibody and eftansomatropin alfa, our long-acting human growth hormone that reported out positive Phase 3 results today. As we look to building out the future for I-Mab, we plan to focus on three strategic pillars. First, rapidly advance our two promising clinical assets globally within oncology. Two, maintain our strong balance sheet. And three, focus on establishing a new operating model to become a US-based global biotech company. Taking them one at a time. One, we plan to advance uliledlimab, our novel CD73 antibody and givastomig our differentiated Claudin 18.2 and 4-1BB bispecific antibody in the US and globally. We believe that both uliledlimab and givastomig each have interesting biology, encouraging early clinical data and differentiated characteristics that have enabled them to stand out from other drugs in development. We believe that uliledlimab could be a critical value driver for I-Mab and if approved, could be a unique and differentiated immuno-oncology agent, which has the potential to be the preferred adjunct to immunotherapies across a wide range of tumors. Our goal is to submit an IND in the first half of 2024 for uliledlimab in combination with chemomotherapy and checkpoint inhibitors in newly diagnosed patients with advanced non-small cell linked cancer. John will further provide details on the data that we presented at ASCO and why these results give us the confidence that uliledlimab can be a differentiated entrant and a significant value driver for I-Mab. We believe that givastomig has a potential to be a differentiated agent in gastric cancer. This unique bispecific antibody was designed to target Claudin 18.2 positive tumors and stimulate pro-immune 4-1BB signaling. Givastomig was designed to selectively target 4-1BB expressing cells in the tumor microenvironment, potentially reducing the risk of systemic toxicity. Claudin 18.2 targeted therapies could represent an important new treatment option, especially for patients with gastric cancers, including tumors of the gastroesophageal junction or GEJ, and esophageal cancer. With encouraging signs of monotherapy efficacy, including in tumors with lower levels of Claudin 18.2 expression, we believe that givastomig has the characteristics that could potentially position the program as a leading candidate in these tumors where there remains a significant unmet medical need. Our goal is to initiate a Phase 1b dose escalation study in the US, Japan and China, in combination with standard chemotherapy and immunotherapy regimens for patients with treatment-naive gastric, GEJ and esophageal cancer in the first half of 2024. John will review our early results and explain why we believe our program could potentially be a valuable treatment option for patients. Lastly, we're pleased to report hot off the press positive Phase 3 data from eftansomatropin alfa, our long-acting human growth hormone candidate being developed for the market in China. This represents a significant milestone for the company as it is the first completed Phase 3 data that we have reported. The new eftansomatropin alfa data met the primary endpoint and achieved non-inferiority compared to Novo Nordisk's Norditropin. These results and the compound's weekly delivering formulation should position eftansomatropin alfa to be a key player in the human growth hormone market in China, which is a market currently dominated by once-daily injectables. This multibillion-dollar market in China is expected to grow over the next five to eight years. with long-acting growth hormones estimated to significantly build market share. As you may know, we have an agreement in place with Jumpcan to commercialize eftansomatropin alfa in China. We have two other clinical assets specifically being developed for the China market, felzartamab, our CD38 antibody, and lemzoparlimab, our CD47 antibody. We expect to commercialize these assets through partners, and John will review the clinical results to date and provide an overview of next steps with these programs being developed for the China market. Now, moving on to our second strategic pillar, we continue to maintain a strong balance sheet. I-Mab's $414 million cash balance adequately supports the execution of the company's strategic plan. We've begun streamlining our spend for the second half of this year to support our key global assets in oncology and rationalizing our spend in other areas. In addition, we will continue monetizing non-global core assets and make the difficult choices where needed in our pipeline to earmark cash for the most promising programs, including exploring external opportunities. And now, the third strategic pillar. We're focused on establishing a new operating model as a US based global biotech company, as this will position us to unlock the inherent value in the single largest pharmaceutical market in the world and the area in particular, where our stakeholders expect to derive the most value from our innovative assets. We embark on this change by building on the company's strong foundation from a core set of differentiated oncology assets, a strong balance sheet and a skilled R&D organization in China now. As I just noted, we also remain open to bringing in new assets that we view as value-driving to complement our existing pipeline. We recognize that to make this company into a truly US-based global biotech, it will involve significant changes ranging from governance, stock market listing, culture to talent management. It is important to emphasize that the full I-Mab Board and I are in full alignment with regard to the future direction of the company. I look forward to providing you with those updates on our progress on this strategic pillar in early 2024. Now, before I hand the call over to John, I would like to recognize the leadership of Dr. Andrew Zhu during his time as Interim CEO. Also, I'm grateful for the dedication and hard work shown by the entire I-Mab team. With that overview, I'd like to hand it over to John to provide clinical details on our key global assets and the novel programs being developed specifically for the China market. John?

Thank you, Raj, and good day to everyone on the call. My name is John Hayslip, and I'm pleased to provide you with a clinical overview. First, I'd like to provide updates about uliledlimab, our CD73 targeting antibody designed to block a key pathway that tumor cells may use to evade the immune system, adenosine production. As previously reported, uliledlimab is differentiated by design to avoid hook effect biology, which is a potential liability of other competitor drugs in development. Simply put, the hook effect may prevent other drugs from achieving complete inhibition of enzyme function. The uliledlimab is designed to allow up to 100% inhibition due to its unique functionality. At the American Society of Clinical Oncology Meeting in June of this year, we shared encouraging clinical and translational findings from a Phase 1b/2 study indicating patients with advanced non-small cell lung cancer receiving uliledlimab and PD-1 inhibitor toripalimab. Uliledlimab was well tolerated using an every three-week dosing regimen in combination with toripalimab. Most treatment-related adverse events were Grade 1 or 2 in severity. In the 67 efficacy evaluable patients, the objective response rate, or ORR, was 31%, regardless of CD73 or PD-L1 expression. Notably, patients whose tumors had high levels of CD73 expression experienced a higher response rate than those with lower CD73 expression. The response rate increased to 63% in patients who had both high levels of CD73 expression and a PD-L1 tumor proportion score, or TPS, of greater or equal to 1%, whereas patients with low CD73 expression had an ORR of [28%] (ph). We are excited by these preliminary findings of a correlation between higher CD73 expression and an increased response rate. With this chemotherapy-free uliledlimab and checkpoint inhibitor combination. Data from other studies have suggested that chemotherapy may increase CD73 expression in cancer cells, and we are eager to begin combination studies of uliledlimab with chemotherapy in the near future. Additionally, at the time of the data cutoff, with a median follow-up of 10.4 months, 18 of the 21 patients whose tumors had achieved an objective response remained on treatment, and the median duration of response was not yet reached. Progression-free survival and overall survival data will be analyzed when the data are fully mature. Additionally, we continue to enroll patients with previously treated ovarian cancer to the combination regimen of uliledlimab and toripalimab and expect to report preliminary results in 2024 for this Phase 2 cohort of patients. Building upon these encouraging clinical findings and other non-clinical investigations, we plan to file a new IND with the FDA to expand the uliledlimab program and combined with chemotherapy and checkpoint inhibitors for patients with newly diagnosed advanced non-small cell lung cancer. Owing to the potential effect of chemotherapy to upregulate CD73 in tumors, we hope this combination may benefit in even broader group of patients, potentially regardless of pretreatment CD73 expression. I'd like to emphasize this important point. We plan to evaluate uliledlimab with chemotherapy and checkpoint inhibitors in patients regardless of the CD73 expression before initiating treatment. Non-small cell lung cancer is one of the most common and deadly cancer diagnoses globally. And we believe that uliledlimab has the potential to improve upon currently available care. We plan to discuss further details regarding the planned studies in the first half of 2024 after we have had initial discussions and alignment with regulatory agencies. Next, I'd like to provide an update on givastomig, our Claudin 18.2 x 4-1BB bispecific antibody, a program that has made significant clinical progress. As you may know, other groups have attempted to develop 4-1BB engaging drugs in the past because 4-1BB is a strong stimulant to the immune system. Unfortunately, earlier attempts to develop 4-1BB drugs caused severe toxicities because the widespread effects of 4-1BB stimulation cannot be tolerated by patients. Therefore, we developed the unique approach of this bispecific antibody in that it first binds to tumor cells expressing the Claudin 18.2 protein and then the 4-1BB arm can stimulate immune cells in the immediate environment of the tumor. More specifically, givastomig was designed to do two important things. First, to become conditionally active only upon consumer engagement while remaining silent elsewhere to avoid or minimize liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. And second, to effectively maintain strong tumor binding and antitumor activity attributable to a synergistic effect of the bispecific Claudin 18.2 antibody and 4-1BB antibodies. We believe givastomig has achieved our design goals for this molecule based on early clinical data. This July, the Journal of Immunotherapy of Cancer, or JITC published a paper detailing the significant potential givastomig in treating gastric cancer and its unique molecular design and properties. Looking forward, I am happy to report that the first clinical abstract for givastomig has been accepted for presentation at the European Society of Medical Oncology, or ESMO, in October of this year. While the specifics of the study results are embargoed until the meeting, I'm happy to report that in the dose escalation Phase 1 study, objective responses have been observed with single agent givastomig amongst patients who have received multiple previous treatments for their cancer, including chemotherapy and checkpoint inhibitors. A dose expansion cohort in this Phase 1 study continues to enroll patients with previously treated Claudin 18.2 positive gastric, gastroesophageal junction or GEJ and esophageal cancer with givastomig monotherapy, and interim results for these patients are anticipated in the first half of 2024. Additionally, based upon these encouraging observations and recent nonclinical studies indicating a positive benefit for the combination, we plan to launch new investigations of the combination of givastomig with standard chemotherapy and immunotherapy regimens for patients with treatment-naive gastric, GEJ and esophageal cancer. We anticipate enrollment to begin by the first half of 2024 and plan to provide further details once we finalize the trial design. Speaking of our clinical bispecific programs, TJ-L14B was designed to treat PD-1 or PD-L1 antibody resistant tumors. Like givastomig, the antibody acts by inducing conditional activation of 4-1BB when it binds to its target, in this case, PD-L1. A Phase 1 dose escalation study is underway in patients with progressive locally advanced or metastatic solid tumors that have relapsed or are refractory following prior lines of treatment. A preliminary efficacy signal has been observed and a maximum tolerated dose has not yet been reached. The dose expansion portion of the Phase 1 study is underway in the US and South Korea. The program is being developed in collaboration with ABL Bio. Today, we reported the first positive Phase 3 results from an I-Mab sponsored program with the successful trial of eftansomatropin alfa with weekly dosing for children with human growth hormone deficiency. The results we are sharing today highlight that the Phase 3 study met its primary endpoint of annualized high velocity, or AHV, at week 52 and demonstrated that eftansomatropin alfa was non-inferior to Novo Nordisk's Norditropin. As a reminder, eftansomatropin alfa was given as a weekly injection, while Norditropin was given as a daily injection in this study. The mean AHV was 10.76 centimeters per year for eftansomatropin alfa versus 10.28 centimeters per year for Norditropin with a non-inferiority p value of less than 0.0001. Eftansomatropin alfa was well tolerated and no drug discontinuations were reported due to treatment-emergent adverse events. We believe the safety profile of eftansomatropin alfa appears comparable to Norditropin in this study. These data create a strong clinical database supporting the potential clinical utility of I-Mab's long-acting human growth hormone candidate. We plan to submit a BLA in China in 2024. Next, I'd like to turn to felzartamab, a fully human monoclonal antibody directed against CD38, in development for the treatment of multiple myeloma. We have successfully completed the first trial with registration potential in China for felzartamab as a third-line treatment for multiple myeloma. Our study confirmed the efficacy of felzartamab and with additional benefits such as a shorter infusion time and lower infusion-related reaction rate than reported for daratumumab in its IV form. These product attributes may allow felzartamab to be used in an outpatient clinic setting and together create a potentially differentiated product profile. We are evaluating our regulatory strategy and plan to provide an update following further discussions with the China CDE. We plan to share additional clinical data after those discussions are completed. In terms of the Phase 3 randomized study of felzartamab in combination with lenalidomide for patients who have received one prior line of treatment, enrollment was completed in September of 2021. The primary endpoint for this study is progression-free survival, and we expect the study to read out in 2024, followed by a planned BLA submission. Lastly, the development of lemzoparlimab, focused on China, has the potential to be the first-in-class CD47 antibody for hematologic malignancies in this market. The Phase 3 program is evaluating lemzoparlimab in combination with azacitidine as first-line treatment for patients with newly diagnosed higher-risk myelodysplastic syndrome. Enrollment in the Phase 3 trial was initiated in April of 2023. The company will continue to review follow-up data from our Phase 2 clinical study in higher-risk MDS and while at the same time, analyzing details from trials evaluating other CD47 targeted agents as they are released to inform our decisions on the future steps for the program. I'll now hand the call over to Richard to discuss our financial results.

Thank you, John. Now I will review our first half 2023 financial results. As of June 30, 2023, the company had cash, cash equivalent, restricted cash and short-term investment of RMB3 billion or $414.6 million compared with $489 million as of December 31, 2022. I-Mab's strong cash balance is estimated to provide the company with adequate funding to support the execution of the company's strategic plan. As you may have seen today, we also announced that the Board has authorized a stock repurchase program of up to $40 million to enhance shareholder value of the company. Total revenue for the first six months of 2023 were $2.7 million compared with $7.7 million for the same period in 2022. Revenue consists of revenues recognized in connection with the strategic collaboration with AbbVie and the revenues generated from the supply of investigational products to AbbVie and Human Immuno Biosciences or HI-Bio. Now let me turn to the R&D expenses. Research and development expenses for the first six months of 2023 were $61.6 million compared with $67.6 million for the same period in 2022. The decrease was primarily due to the reduced payroll expenses and share-based compensation expenses, partially offset by a slight increase in Chemistry, Manufacturing and Controls service fees. Administrative expenses for the first six months of 2023 were $33.8 million compared with $54.1 million for the same period in 2022. The decrease was primarily due to lower payroll expenses and share-based compensation expenses and related to management personnel and lower expenses for professional services. Non-GAAP adjusted net loss, which excludes share-based compensation expenses for the first six months of 2023 was $87.5 million compared with $116.9 million for the comparable period in 2022. As of June 30, 2023, I-Mab has approximately 190 million shares outstanding. I would like to reiterate our strong cash position of $414.6 million as of June 30, 2023, which allow us to execute our strategic plan. Lastly, please note that the conversion of certain RMB amounts into US dollars for historical periods presented in this call may not be identical to the ones that previously announced due to the differences in particular exchange rate used by the company for this one compared to the historical exchange rates. With that, I would like to turn the call over to Raj for the few closing remarks. Raj?

Thank you, Richard. To conclude, I'm even more convinced than before that I made the right choice to join I-Mab and that we're on the right track with the strategic plan. Looking ahead, we intend to advance our two lead oncology assets, uliledlimab and givastomig rapidly into initial studies in the US and beyond in the first half of 2024. We plan to maintain our strong balance sheet by continuing to streamline and rationalize our spend to advance the most promising programs and we intend to focus on a new operating model to establish a US-based global biotech company with the full support of the Board. We're excited about I-Mab's new strategic plan and look forward to providing you with periodic updates on our progress. Thank you all for taking the time to join us today. I'll now turn the call over to Tyler for the Q&A session.

Thank you, Raj. [Operator Instructions] I would like to direct our first question to Kelly Shi. Kelly, please go ahead.

Thank you, Tyler. And congrats on the great progress and thank you for taking my questions. Firstly, could you comment on the safety profile of your weekly injected growth hormone from Phase 3 trial and in comparison to other competitor weekly programs? And also, could you let us know the projected timeline for regulatory approval and also commercial launch? And I also have a follow-up. Thanks.

Yeah. Kelly, thank you for that question. We are quite excited about the potential of eftansomatropin alfa as a weekly option for our patients. And given the strong results that we just disseminated, I believe this will be a valuable option in the China market, especially in a growing multibillion-dollar growth hormone market. I think I'll let John comment on it. And then Andrew, if you wanted to comment more on Kelly's question and how it compares to other drugs in development, that would be great. John?

Yeah. Thank you, Raj. Thank you, Kelly, for the question. As Raj mentioned, this trial is a randomized head-to-head trial against Novo Nordisk's Norditropin. And as we review the results coming in from this trial, we're quite pleased by the safety profile that we've observed in this trial as compared to Norditropin. In addition, I think we're pleased with how the safety profile of this drug looks compared to other drugs in the field and we look forward to disclosing those more completely in the future as we disclose the full data set. I'd like to ask Andrew, if you'd like to add any additional comments.

Andrew, are you on?

Yes, can you hear me?

Yeah, we can hear you.

Yeah. Kelly, thank you for the question. As you know, we just actually released the results. All the secondary endpoints, including safety and also various variables of the clinical data are being actively analyzed. And right now, we can definitely say the safety profile compare very, very comparable to the weekly injection. And definitely, we will share the data very, very soon. With regard to the second part of the question, we are actively pursuing the BLA submission. Definitely, we think with the Phase 3 data this provide the solid foundation for us to engage this process. And obviously, we're starting the engagement with regulatory agency. So hopefully, we will have additional timeline to report soon. Thank you.

Andrew, I just wanted to make one clarification. I think the safety profile compared very favorably to the once-daily injection Norditropin.

Thank you for your question, Kelly. With that, I would like to direct the next question to Joe Catanzaro. Joe, please go ahead.

Hey, guys. Hopefully, you can hear me okay. I guess I had two questions. Maybe first one on givastomig and particularly as it relates to Claudin expression levels. Wondering with the potential approval of zolbetuximab, I guess, next year, whether based on what you've seen thus far, whether there's opportunity to maybe capture a broader Claudin expression range with givastomig? Thanks, and I have a follow-up.

Thanks, Joe. As you can tell, we're very excited about this particular program, including our TJ-L14B that we're collaborating with ABL Bio. But in particular, we continue to believe that givastomig is quite differentiated from the agents that are in development. I'll ask John to comment more on the specific area of Claudin 18.2 that you specifically referred to. John?

Yeah. Thank you, Joe. So, as I alluded to in my comments, in a non-clinical time, early in the development of givastomig, we've seen that givastomig can be efficacious have biologic effect down to very low levels of Claudin expression. And in addition, you'll see in our clinical data, we've seen clinical benefit in patients who have quite low levels of Claudin expression. So we're optimistic -- the program is early still, but we're optimistic that givastomig may be able to bring benefit to a broader and much broader group of patients with lower Claudin 18.2 expression as well.

Great. That’s helpful. And maybe my follow-up question quickly on lemzoparlimab in the ongoing Phase 3 trial in MDS in China, because it sounds like there's a lot of considerations there and the maybe situation is fluid. But I guess now knowing the outcome of magrolimab's ENHANCE trial, just wondering how you think about what ultimately we could see from that trial and how it influence your decision with lemzoparlimab and its clinical strategy? Thanks.

Thanks, Joe, for that question. I think this was an intensive discussion as well within the company, as you can imagine, with the recent results from the other CD47 targeting agents. I think it will be premature for us to make a decision on our molecule. We continue to believe that our molecule is differentiated. And we continue to enroll in our ongoing Phase 3 study in China. We do plan to review interim data early next year and complete an advisory panel to review all of the class data as it becomes available. and to compare what we have and then I would think our shareholders would appreciate that to make an informed decision in the first half of next year in advancing the molecule. So we'll certainly further analyze the details of the ENHANCE study as well as the data becomes available in the public markets.

Okay. Perfect. Appreciate you taking my questions. Thanks so much.

Thanks, Joe.

Thank you, Joe. I'd like to direct the next question to Louise Chen. Louise, please go ahead.

Hi, thank you for taking my questions here and congratulations on the progress this quarter. So Raj, I wanted to ask you if you could elaborate more on your vision for I-Mab and how long it will take you to reach your objectives? Secondly, on CD47 again, just curious where you stand with your outside of China opportunity with AbbVie here and when you might reveal more details on your next-generation CD47 or is that project on hold right now? And then I know you've mentioned the givastomig ESMO presentation, but are there any other important data presentations throughout the end of the year at health care conferences that should be on our radar? Thank you.

Yep. Thank you, Louise, for all those questions. I'm going to remember every one of them as much as possible. And if I do forget, please reiterate it. We were practically writing those questions down. So the first one is what's the timeline that I expect to deliver on the strategic objectives or the plan that I laid out? I think as you will see in the next couple of years, there's quite a few catalysts that are going to become available to our stakeholders. And so I think I give myself 24 months to be able to start looking at the strategic plan and the progress that we've made. So that will be an important timeline for investors to understand that this is not going to happen overnight, but the shift in the focus and how we're thinking about making into a US-based global biotech is going to take time. But again, I think if I had to put pen to paper and think about a timeline that should be important, it should be by the end of 2025, second half of 2025, we should be in a good position to look back and say, how is our strategy working and how is it enhancing the value for our shareholders. So that was the first question, I believe, Louise. The second question is on lemzo outside of China. As you can imagine, as we've said before, right, that AbbVie had terminated the development, global development of lemzo, but we have the rights to China. So we continue the trial in China. At this time, we have no plans to initiate a study until we see the interim data, we analyze the class data of the other CD47 targeting agents, and we meet with an expert panel to be able to understand if our molecule is truly differentiated from the other CD47, and we can come back at that time, Louise, to clearly articulate as to if we're going to move forward with lemzo or the backup compound. And then the last question, Louise, was on the -- sorry...

Conferences. Anything on the -- aside from ESMO, I know you mentioned givastomig from ESMO, but any other of your main compounds going to be presenting new data at conferences throughout the remainder of the year?

As far as we know, I don't think there's anything that jumped out to us for the rest of the year, but I'll let John comment on it. John?

Yeah. Thank you. So as we mentioned, we plan to present the givastomig dose escalation clinical findings at the European Society of Medical Oncology in October this year. Also, as I mentioned, we anticipate the dose expansion cohort, the continued enrollment of patients with gastric GEJ, and esophageal cancer. We expect to have interim results early next year from that cohort of patients. So we'll be reviewing those results and bringing those forward as quickly as possible. But for the remainder of 2023, no additional conferences to add at this time.

Okay. Great. Thank you very much.

Thank you, Louise.

Thank you, Louise. The next question we will direct to Ethan Markowski. Ethan, please go ahead.

Hi, everyone. This is actually Gil, not Ethan. So maybe a quick one on the commercial opportunity for eftan. Are you guys thinking of pricing it similar to the current standard of care in China, if you had any thoughts there?

Hi, Gil. I think it would be a little premature right now to comment on price. But I do know that we're excited about the profile of the compound itself in terms of the benefit that it could bring to patients. And we're excited about the growing large commercial opportunity that we have available for the human growth hormone product. So I think we're going to price it competitively. I can definitely assure you that, but I think it's a little too early for us to actually comment on price publicly before we've even filed the product.

Okay. And maybe a quick biology question on givastomig. So signaling for 4-1BB usually requires trimerization of the ligand, which links to these weird-looking bell curves, a little bit like the hook effect. I'm just wondering, have you seen that in preclinical studies with givastomig or is this even an issue? Thank you.

John, do you want to take that?

Sure. Yeah. Thanks, Gil. Good to hear from you. So this has not been a non-clinical -- is not a preclinical issue for givastomig. And further in the early clinical findings, we continue to see systemic pharmacodynamic effect of soluble 4-1BB in a predictive manner. So we've been quite confident about what we've observed today with givastomig regarding the PD effect.

[Indiscernible] questions.

Thank you, Gil.

Next up, I would like to direct the next question to Andres Maldonado. Andres, please go ahead.

Hi, thank you very much for taking my questions and congrats on the progress. Just one quick one, maybe for Raj from us. Could you elaborate on where do any initiatives for finding commercial pipeline -- commercial partnerships for the pipeline fall with your new vision for the company? Obviously, prior to you joining. There was a lot of talk on partnering uliledlimab. I'm curious on your thoughts on the potential for partnerships outside of uliledlimab and how they align with your vision? Thank you.

Yep. Thank you for that question. I think as I look within the company and talk with my colleagues in R&D and in business development, we're very excited about our assets. And we think they have interesting biology. They have produced early encouraging clinical data. And I think we have a very healthy balance sheet to be able to take them forward on our own at this time. I think it will be -- in my estimation, premature to start talking about partnering until we actually produce mature data, either proof of concept or the ability to actually have a higher probability of success in taking these to market. And I think that, that time would be ideal to talk about if appropriate, depending on what else do we have in terms of opportunities to be able to talk about do we need a partner and why? But I will say also as a note, we continue to get incoming inquiries of interest on these assets, and we continue to engage with these outside partners. But that doesn't mean that we are keen on partnering until it makes strategic sense, and we believe that, that option produces the highest value for our shareholders in the near to midterm.

Thank you for your question, Andres.

Does that answer your question, Andres?

Yes. Thank you very much.

Thank you.

I'd like to direct the next question to Qu Xiaoyi. Xiaoyi, please go ahead.

Hi, this is Xiaoyi from CICC, and thanks for taking my question. I have a quick one on the CD73 antibody. So we see very encouraging results of this antibody in first-line non-small cell lung cancer. And in the 1b/2 Phase I2 trial, there are about 60-ish patients that has both high CD73 and PD-L1 expression, and the ORR reaches really high for this population. Do you predict similar percentage of target patient population in the real world? Or like what's the target population like in average for this -- both like double positive expressing patient population in the real world? And also for the pivotal trial, I just want to ask about the design for this trial. I see like for the patients that with really low TPS expression, you see like the response is minimal. And by adding the chemo on top of the immune checkpoint inhibitors, do you see any evidence preclinically or clinically that adding chemo can boost the sensitivity of these PD-L1 active patients in the response to CD73?

Yep, Xiaoyi, that’s very good questions on uli. Let me just take the first comment, and then I'll pass it on to John. I think all of the results that we've generated in the program to date give us the confidence, especially in advancing that program in the settings that John articulated in his prepared remarks. So I think our intent would be to go to a broader group of patients while we will continue to assess the PD-L1 status and CD73 status, but that's just a subset of what we would be focused on. John, do you want to comment more on that and the second question that she had?

Yeah. I would just add that we've been working with WuXi Diagnostics throughout the development program regarding the CD73 biomarker assay. And so the trial that we reported, we enrolled -- we allowed patients to enroll who had newly diagnosed non-small cell lung cancer who were not eligible or who refused to receive chemotherapy. In other words, the patients were allowed to enroll before they even knew their CD73 expression. So CD73 expression to the broader group, that was not an entry criteria. So we would believe we're within the setting of a modest-sized clinical trial. The rates that we observed may be consistent with what we would generally observe in future studies. So of course, the precision around that, we need larger studies to increase our confidence. So I think the rates are -- I think that's what we know about the rates of the double high population. But as Raj said, importantly, as we move the program forward, we do see, as you mentioned, with checkpoint inhibitors, which themselves are not so efficacious as monotherapy for patients with lower PD-L1 expression. But when you combine checkpoint inhibitors with chemotherapy, then the benefit of checkpoint inhibitors expands to the really the broad population of newly diagnosed patients of lung cancer. And so we're optimistic that as we move forward in combinations with chemotherapy, that, that similar -- that rates of benefit like that may extend to the broader patient population and not just those who were elevated prior to the initiation of treatment.

Thank you for your question, Xiaoyi. I'd like to direct the next question to Bing Zhao. Bing, please go ahead.

Yeah. Thank you for taking my questions. This is Bing Zhao from China Renaissance. I'm still interesting about the call the Claudin18.2 and 4-1BB bispecific antibody. Because I realize that the status Claudin 18.2 8. antibody is going to be listened in US, probably second half of this year. And also Astellas is looking for listing in China Mainland as well. So I'm wondering if their products being commercialized, what is affected our future clinical plan? And also, I realize that for Claudin -- for biospecific antibody, there are many combinations on the market, let's say, for example, Claudin 18.2 is with CD3 or Claudin with PD-L1, but I'm interested to know more biologics behind why we choose the Claudin and 4-1BB instead of the other targets? Thank you.

Thank you for your question, Bing Zhao. I think as we -- as you're talking about the positive is there's a lot of interest in the Claudin 18.2 space itself. It's a highly relevant tumor antigen. And as you said, there's a lot of work going on. And we're excited about the differentiation that givastomig has, as we articulated in our prepared remarks, John, do you want to specifically address some of the differences that givastomig to what Bing Zhao brought up in his question?

Yeah. Thank you. So maybe first, I'll just touch upon, we are aware of a lot of the work being done in the field. And I'll just first touch on CAR-T cell therapies, which may hold significant potential. The cost and tolerability may relegate that approach to patients who have received previous treatments in the past. Similarly, we have seen some early reports from ADC type therapies and some of those with encouraging results. But really, we think it's too early to know about those drugs if they'll eventually get to the market or not. And in the past, for example, ADC-type drugs have not always combined well with established treatments. And therefore, are sometimes used after established treatments have been exhausted. Maybe just finally, to touch on the monoclonal antibodies in development, which you mentioned and which may commercialize in the next year or so. These results are indeed important. But as I mentioned earlier, we look for givastomig. We're about to begin combination studies. We intend to study with chemotherapy and with checkpoint inhibitors. And as I mentioned also, we've seen benefit in even monotherapy in patients across a wide range of Claudin expression, including patients with quite low expression have received monotherapy benefit. So we're quite encouraged by what we've seen to date with givastomig and the ability that givastomig could help address the unmet needs for a wide range of patients. and look forward to initiating those studies to combine with current standard frontline treatments.

Hey, Raj, could I add one point to John's comments?

Sure Andrew. Sure.

Yeah. So Bing, you're obviously touching a very, very critical point. We are fully aware of the competitive landscape in the Claudin targeting area. However, as John pointed out, I think definitely our drug can actually cover a broad range of clouding expression level. And the second attractive feature is really the safety profile. As you know, for zolbetuximab and all the Claudin targeted native antibodies, they have the class specific toxicity profile. In particular, the GI side effects is actually quite challenging for the clinicians to manage. So our data so far really highlight the favorable safety profile of givastomig. So I think combined with these two features, I think even in the first-line setting, even with the pending zolbetuximab approval, we still think we can actually position our drug very broadly in the first-line gastric esophageal space just because of the broader [indiscernible] with Claudine expression as well as the favorable safety profile. Just want to clarify that point.

And I think -- just one other thing I just wanted to say is, right, we will have more details of the data presented at ESMO, which will be interesting as well for you to take note of.

Yep. Thanks.

Thank you, Bing. Next question. I'd like to direct it to Zhuxuan Jiang. Zhuxuan, please go ahead.

Okay. So, thank you very much for this chance. And my question is about our early-stage pipeline development. So could you elaborate more about the pipelines that are going to enter the R&D stage? Thank you.

Yeah. So great question. I think the early pipeline in China has been -- the China, specifically the talent in China has been a complete foundation and a core driver for innovation in how I-Mab has progressed to date. That being said, I think as you look -- hear the prepared remarks that we have today and the shift and the focus and the strategy is to really focus on those drugs that are in the clinic today to be able to accelerate the development and bring it to market. I think that is a huge shift. While we will continue to look at assets in the earlier stage right now in terms of shareholders and value inflection, we're looking at the next two to five years in terms of how we can maximize the value of the company for our shareholders who have been with us for these years, right? So you'll see more information as we progress the late-stage compounds. We feel comfortable on the likelihood and the success of those compounds getting to market, and we're participating in the market, you'll see more data on how we start focusing on preclinical and early stage compounds. Does that answer your question?

Yes, thank you.

Thank you, Zhuxuan. We will take one last quick question. We have three minutes left. I would like to direct the last question to [indiscernible]. Please go ahead.

This is [indiscernible] from Citi Research, and thank you for taking my question. And I have two more questions. One, the first one is about the CD47 projects. And we know that the [Gilead and Bayer Oncology] (ph) just terminated their project due to limited efficacy. So could you give us more color on the efficacy gap between the Phase 2 and the Phase 3 trial? And we know the primary endpoint for our Phase 3 trial is overall survival. And can you comment more about the improvement in the ORR rate to the benefit of the [indiscernible]? And yeah, it's the first question. And the second follow-up, the [indiscernible] project for -- and for the -- for our coming pivotal study, where the regulatory open green lights for single-arm pivotal study or it should be head-to-head Phase 3 study? Thank you.

So thank you for the question on lenzo and then uli as well. So let me just reiterate on the lenzo one, right? So we have seen the announcements from the CD47 targeting companies recently. And as we said, this was obviously a great interest to us in terms of the announcement itself and how that impacts our program. As we said before, I think it's a little premature for us to think about a decision whether we should continue or stop the molecule development. I think we continue to enroll our ongoing Phase 3 study in China. We continue to believe that our molecule is differentiated. But as we said, we are also going to review the interim data. We're going to look at the full data from these CD47 that have announced their trial termination fully and then meet with experts to be able to make an informed decision on CD47. So that, I think, is a crux of how we're thinking about our program. As we said, this is only in China. We are not progressing with lenzo anywhere else outside of China until we get that information in our hand. On the uli question, let me pass it on to John to address that question in particular.

Thank you, Raj. So I'd just add regarding uliledlimab and the potential development pathways. We have the utmost respect for the regulatory agencies. Certainly, they have a challenging task and regulatory guidance changes from time to time. So at this point, we would not comment further regarding the specific regulatory pathway for uliledlimab until after we've reached alignment with the right regulators. And then we'll speak further about it after that time.

Does that answer your question?

Yes. Thank you.

Thank you. And with that, we're running a little over time, so we will conclude today's call. If there are any follow-up questions, please feel free to reach out to your local IR representative, and we'll get back to you as quick as possible. Thank you, everyone, have a great day.

Thank you.