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…

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…

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…

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.