NovaBridge Biosciences (NBP) Earnings Call Transcript & Summary

Greetings. Welcome to I-Mab Biopharma's First Half 2024 Financial Results and Corporate Update Conference Call. [Operator Instructions] Please note that this conference is being recorded. I'll now hand the call over to Tyler Ehler, Vice President, 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 obtained 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 we 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 to join 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 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 the 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 having PwC U.S. as our corporate auditor. As you will hear from [indiscernible], 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 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 experience 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, 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 advantage. 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 of a big pharma focus 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, bring 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 7 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 readout randomize the 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 expected 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-PD-L1 and 4-1BB-driven T cell activation. It has been developed for cancers that are relapsed or refractory to checkpoint inhibitors and recently presented a compelling early data at ASCO 2024. I'm optimistic about our portfolio, with our early clinical data, our innovative clinical trial strategies and a strong team driving these programs forward offer 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 sure. Slide 7 begins the section on ULI. ULI target CD73, which is the rate-limiting enzyme critical for converting AMP or adenosine monophosphate into the immunosuppressive metabolite adenosine, Blocking CD73 allows antitumor immunity to proceed in the tumor micro environment 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 illustration 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 [ N-terminus ] and 2 [ C-terminus ]. 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 N-terminus of CD73, what can happen is that as concentrations of drug increase the inter molecular bonds needed to inhibit 73 activity are harder to form, because the antibodies bind to the N-terminus binding sites with single valence. 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 high CD73 expression and a PD-L1 TPS score of greater than or equal to 1%, the experienced an objective response rate, or ORR, of 63%. Patients with lower levels of CD73 expression at a lower ORR. The ORR and the CD73 high group is higher than that observed in KEYNOTE-042, 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, this study also shows that the combination was well tolerated. 2/3 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 as a checkpoint inhibitor or IO combined with chemotherapy. On Slide 10, we outlined 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 4-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 4-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 newly 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 equals to 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 2:1 ratio against standard of care assessing ULI with two different dose levels. In this slide, it's -- 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 readout 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 summarized expected Phase I/II milestones for four other CD73 programs. We believe that 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 to givastomig on Slide 13. givastomig or Giva is the bispecific antibody that is designed to targeting Claudin 18.2 and a tumor-associated antigen found in 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 bispecific antibody. Initial Phase I monotherapy data reported at the ESMO 2023 meeting showed encouraging monotherapy results in patients with gastric cancers, whose tumors have 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 readout 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 cancer 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, and related to Claudin 18.2 expression and clinical outcomes. On the right-handed 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 and 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 one plus or greater than at least 1% of cells. When Claudin 18.2 parameters were tightened to 2-plus 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 conditional 4-1BB engagement is intended to optimize the compound for safety, including the potential for lower hepatotoxicity compared to traditional 4-1BB agonist. Localized activation of 4-1BB and the tumor microenvironment is intended to enhance antitumor 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%. 71% of patients who responded had received prior checkpoint inhibitors. The complete response was observed in a heavily pretreated 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. Enrollment in selected indications and different dose schedules is ongoing. Slide 18 provides a snapshot of the safety profile, while increased liver enzymes for the most common treatment-emergent adverse event, none of the transaminase elevations were accompanied by increases in bilirubin, the so-called Hy's law. Patients with Grade 3 increases in liver enzymes improved with corticos treatment, 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. We 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 in 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 PwC U.S. as our financial auditors. As we move to Slide 21, I would like to take you through a pro forma cash flow. 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. And 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 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 recasted 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 defensing shareholder, which has been subsequently settled, foreign exchange losses incurred on the transfer of renminbi to U.S. dollars and other nonrecurring expenditures associated with the divestiture. Item C, during the first quarter, there were $47.1 million in consolidated operating expenses in the I-Mab Group pre-closing of the divestiture. Item B (sic) [ D ], in the second quarter, there were $1.6 million in additional nonrecurring expenses incurred associated with the divestiture. Item E in the second quarter, there were $12.1 million in operating expenses of I-Mab as a stand-alone 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 represented an equivalent of 81.4 million ADSs. 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 expected to present updated Phase I dose expansion data at the ESMO 2024 meeting. And we expected to provide top line data from the Giva combo study in gastric cancers in the second half of 2025. For ULI, we expected to initiate the first patient dosed in the combination study in patients with advanced non-small cell lung cancer in the first half of 2025. And we expect it 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 completed key governance and corporate development milestones. As we look forward, we will continue to think strategically to evaluate the new opportunities to further enhance our pipeline. We are squarely focused on execution and we believe a combination of our differentiated pipeline, experienced the leadership team and strong cash balance position will led us to 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.

[Operator Instructions] Our first question will be coming from the line of Joe Catanzaro with Piper Sandler.

Maybe I had a couple on givastomig. First one on the upcoming ESMO update. Wondering if you could just help sort of set expectations in terms of the data set, we'll see patient numbers, and any new learnings around the monotherapy profile there? And then second question, I appreciate the comparison to zolbetuximab. I'm wondering if you had any thoughts on how Giva maybe compared to the growing, Claudin 18.2 ADC landscape and where it could differentiate versus those programs?

Thank you for the question, Joe.

Thanks for the question.

I'll turn that question over to our Chief...

Go ahead, Tyler.

I'm 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 raised an important question. The way we envision Giva's development is given its tolerability is to combine it with frontline therapy with nivolumab and regimens such as FOLFOX. And I think that is the basis for the differentiation with other 18.2 targeted assets. So while we know that ADCs, given their toxic payload, can have a notable objective response rate, which, again, if we compare Giva against the ADC that is being developed by AstraZeneca, our ORR is inferior, but arguably, our tox profile is much better suited for a combination of frontline studies. And I think that's the differentiating feature. I think for an ADC targeting 18.2%, the movement to frontline therapy, one would have to make accommodations in the standard of care chemotherapy because it simply will 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.

Our next question comes from the line of Kelly Shi with Jefferies.

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

Thank you for your question, Kelly. Is it possible to repeat the first question, and 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 the fully transitioning to a U.S.-based auditor?

Yes. Thanks for that question. We have completed the transition and PwC U.S. is now our corporate auditor and we've been working closely with them since the completion of the transition. So this is an important accomplishment. And together with other corporate developments after the divestiture you can start 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 [ growing ] burn rate will be considerably lower compared to what you saw in the first and second quarter of this year because we have streamlined our organization, we focus on clinical development programs going forward. And 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 folks, 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. And I think the final part of your question has to do with going forward, the pipeline strategy. We are squarely focused on execution of our internal pipeline to see that we explained in detail today by Phillip's. And we're excited about these pipelines. So what we're looking to license in and we're looking for collaboration opportunities from external partners. Important to know that when we think about the BD strategy, we are looking for assets that has the potential to enter or already in clinical stage. Therefore, we can expect it to bring a near-term value inflection for I-Mab in the next year.

[Operator Instructions] Our next question is from the line of Andres Maldonado with H.C. Wainwright.

Congratulations on the progress. Just two quick ones for me. So 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? And then as an additive question, in the second half, the Phase II PFS data from the TJ Bio study. Just curious on how are you going to leverage that data moving forward and what you need to see there?

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

Thanks. And I will address the questions in order and if I don't do so completely, please -- let's -- I'll make sure to address all of them. In terms of benchmarks for efficacy in our Phase II, the sense is that the comparison is KEYNOTE-189, where we know the median PFS is about 9 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 III unresectable disease, as well as antibodies against 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 a CD73 selected population, we will get support for our hypothesis that it's the patients that have five CD73 expression that benefit most from ULI.

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, and you can gather from the discussions and the presentations, we're very excited about the pipeline. I think the team is dedicated to continue to push the pipeline forward in the most efficient and a scientific way. And 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 Relationships. Have a great day. You may now disconnect the call.

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