Q2 2024 I-Mab Earnings Call

Speaker Change: i

Operator: with Bioformer's First Half 2024 Financial Results and Corporate Update Conference Call. This time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. If you'd 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.

Speaker Change: Greetings. Welcome to IMAB Bioformers. First half 2024, financial results and corporate update conference call. This time, all participants are in listen only mode. The question and answer session will follow the formal presentation.

Speaker Change: If you'd like to ask a question, please press star 1 on your telephone keypad and a confirmation tool to indicate your line is in the question queue. You may press star 2 if you'd like to withdraw your question from the queue. For a participant that are using speaker equipment, it may be necessary to pick up your hands set before pressing the star keys.

Speaker Change: Also, if anyone should require operator systems during the conference, please press star 0 from your telephone keypad.

Operator: Please note that this conference is being recorded.

Tyler Ehler: I'll now hand the call to over to Tyler and Vice President of Vest Relations. Tyler, you may now begin your presentation.

Speaker Change: Please note that this conference is being recorded.

Speaker Change: I'm now here in the call to over to Tyler and our Vice President of Vester Relations. Tyler, you may now begin your presentation.

Tyler Ehler: Thank you, operator, and welcome everyone to I-Mab via Pharma's first half 2024 financial results and corporate update conference call. This morning, I'm at 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.

Tyler: Thank you, operator, and welcome everyone to IMAP Biopharmus 1st half 2024 financial results in corporate update conference call.

Tyler: This morning, I'm at issue the press release reporting that's first half 2024 financial results and corporate update. The access to copy of the press release.

Tyler Ehler: Before we begin, I would like to remind everyone that statements majoring 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.

Tyler: Please visit the Investor Relations page of the company's website.

Speaker Change: Before we begin, I would like to remind everyone that statements, majoring in this conference call will include forward-looking statements on the State Harbor provisions of the Prime Security Litigation Reform Act of 1995, which involves risks and uncertainties that can cause results that they're from materially.

Speaker Change: Overlooking statements, because only as of the date they are made as the underlying facts and circumstances may change, except as required by law, I am at undertake new obligations to update these forward-looking statements to reflect future information, events, or circumstances.

Tyler Ehler: 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 bleed through 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.

Speaker Change: 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.

Speaker Change: All of the market data used in this presentation involves a number of assumptions and limitations. And you are caution not to give undue weight to such data.

Speaker Change: In the three publications and third-party research surveys and studies, generally indicate that their information has been obtained from source of lead to a reliable reliable. Although they do not guarantee the accuracy or completeness of such information.

Speaker Change: For estimates of the potential market opportunities for our product candidates, include several key assumptions based on our industry knowledge.

Speaker Change: 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 one's sentence source has verified such assumptions.

Tyler Ehler: While we believe that our internal assumptions are reasonable, no intended source has verified such assumptions.

Tyler Ehler: For more information on forward-looking statements, please review the disclaimers and today's press release and the risk factors in the company's SEC filing.

Speaker Change: For more information on forward-looking statements, please review their disclaimers in today's press release, and the risk factors in the company's SEC filings. With that, I'll now turn the call over to Dr. Sean Foo. I am Abs. Interim Chief Executive Officer and Board Director.

Dr. Sean Foo: With that, I'll now turn the call over to Dr. Sean Foo, 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 IMF. 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 developers. For this module's call, I will make a few opening remarks regarding our strategic milestones, organization, and pipeline.

Sean Foo: Thanks, Tyler, and thanks to everyone to join us today.

Speaker Change: So far this year, 2024 has been transformation of RIMA.

Speaker Change: 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.

Speaker Change: For this morning's call, I will make a few opening remarks regarding our strategic milestones, organization and pipeline.

Dr. Sean Foo: After that, Dr. Philip Dennis, our Chief Medical Officer, will provide an update on our three differentiated immuno-oncology therapeutic programs with upcoming milestones. And next, Joel Skelton, our Chief Financial Officer, will run through a few key financial items, including a review of our cash balance and runway.

Phillip Dennis: After that, Dr. Phillip Dennis, our chief medical officer, will provide an update on our three differentiated immun oncology therapeutic programs.

Joe Skeleton: With upcoming milestones and next, Joe Skeleton, our Chief Financial Officer, will run through a few key financial items, including a review of our cash balance and runway.

Dr. Sean Foo: I'll wrap up with a few closing remarks, then we'll open the call for questions.

Joe Skeleton: Our wrap-up is a few cursing remarks, and we'll open the call for questions.

Dr. Sean Foo: 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, experience, 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 was the divestiture of operations in China, announced earlier this year on April 2nd.

IMAB: I join IMAB as a board director and interim CEO about a month ago.

Speaker Change: As I've become more familiar with the organization, I'm more enthusiastic about I-MAD and all the team has accomplished so far this year.

Speaker Change: Furthermore, I believe the combination of our differentiated pipeline, experience the leadership team, and strong cash position, will allow us to make a meaningful progress in the second half of the 2024 and beyond.

Speaker Change: I'd like to share some of our notable accomplishments from the first half of this year.

Speaker Change: First, was the divestiture of operations in China, announced earlier this year on April 2. We established a new operating model as a US-based global biotech company.

Dr. Sean Foo: We established a new operating model as a U.S.-based global biotech tool. As part of the transaction, we also extinguished $183 million of the redemption obligations. Subsequent to the second quarter, we extinguished an additional $17 million of the redemption obligation. We have efficiently worked to streamline our organization and build a new U.S.-based leadership team, which includes the addition of Joel S. C.F.O. and Philip S.C.M.O. From a corporate governance perspective, we successfully transitioned to having PWC U.S. as our corporate auditor. As you will hear from Philip, we have significantly advanced our three oncology programs. We are squarely focused on execution and believe we're well-positioned to make additional progress through the end of this year and beyond.

Speaker Change: As part of the transaction, we also extend which 183 million dollars over redemption obligations.

Speaker Change: Subsequent to the second quarter, we extinguished an additional $17 million of a redemption obligation.

Speaker Change: We have efficiently worked to streamline our organization and build a new US-based leadership team, which includes the addition of Joe at CFO and Philip at CMO.

Speaker Change: From the corporate governance perspective, we successfully transitioned to having P2CULS as our corporate auditor.

Speaker Change: And you will hear from Chile.

Speaker Change: 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.

Dr. Sean Foo: 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 five. Establishing and experience the U.S.-based management team is critical to IMAP'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 was a focus on immuno-oncology. Identifying and completing strategic transactions, raising capitals, and building successful organizations. In my experience, these are some of the core competencies for successful bottom-up companies today.

Speaker Change: 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.

Speaker Change: Moving to slide five.

Speaker Change: Establishment and experience the US-based management team is critical to eye maps long-term success.

Speaker Change: Our diverse leadership team has experiences in many areas, including conceiving and implementing strategic plans for asset development.

Speaker Change: Deep scientific know-how in developing early-stage targeted therapies for cancer was a focus on immun oncology.

Speaker Change: Identifying and completing strategic transactions, rating capitals, and building successful organizations.

Speaker Change: In my experience, these are some of the core competencies for successful boss on the companies today. Our leadership team exemplifies these core competencies.

Dr. Sean Foo: Our leadership team exemplifies these core competencies. Our collective professional experiences and stellar track records is one of IMAP's most important strategic competitive events.

Speaker Change: Our collective professional experiences and stellar track records is one of IMAP's most important strategic competitive advantage. I'm pleased to introduce you to the IMAP Leadership Team.

Dr. Sean Foo: I'm pleased to introduce you to the I-Mab leadership team, including our new CMO, Philip Denner. Philip is a renowned lung cancer expert with broad clinical development expertise across a range of therapeutic modalities. With over ten years of a big format, focus on immunoncology, antibody conjugates, and target therapies. Our CFO, Jill Skelton, is an experienced investment banker with a track record of successfully executing numerous transactions for biotech and biopharma companies throughout her career. Our vice president of clinical development, Claire Shrewd, playing significant clinical execution experience, running oncology clinical trials, and has been a core part of I-Mab's historical U.S.

Speaker Change: including our UCMO, Philip Daniels.

Philip Daniels: Philip is a renowned lung cancer expert with broad clinical development expertise across a range of therapeutic modalities.

Philip Daniels: With over 10 years of a big format focused on immunol oncology, antibody conjugates, and target therapies.

Speaker Change: Our CFO Jill Skeleton is an experienced investment banker, with a track record of successfully executing numerous transactions for biotech and a biopharmac companies throughout his career.

Speaker Change: Our Vice President of the Clinical Development, Claire Shoot, links to significant clinical execution experience running oncology clinical trials, and has been a core part of IMAB's historical U.S. operations.

Dr. Sean Foo: 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.

Speaker Change: having been at IMAP for almost seven years.

Speaker Change: I'm impressed by the team's deep understanding of our clinical programs and there's some serious dedication to strategically advancing our pipeline in the best way possible.

Dr. Sean Foo: Moving to slide six. Our pipeline includes three oncology programs, folks on providing meaningful therapeutic options, the cancer patients with significant on-men medical means. All of these assets are commercially attracted, supported by code development and clinical supply agreements with Bristol Mars, with TJ-Vile and AVL-Bile. Our lead program, U.L.I.Mab, is an antibody that targets C-G73. We're developing it with a treatment of metastatic non-small cell lung cancer and expect to initiate a frontline combination study in the first half of 2025. Meanwhile, TJ-Vile, our collaborator, expects to lead out, randomize the phase two PFS data, combining U.L.I.E and Toli-Palimab in the second half of 2025.

Speaker Change: Moving to slide 6

Speaker Change: Our pipeline includes three oncology programs, folks on providing meaningful therapeutic options, the cancer patients with significant on-memmetico needs.

Speaker Change: All of these assets are commercially attracted, supported by co-development and clinical supply agreements with Bristol Marswib, TJ Vyle, and ADL Vyle.

Speaker Change: Our Lead Program, U.D. Love and Map, is an antibody that targets CG73. We're developing it for the treatment of a metastatic non-small cell lung cancer and expect to initiate a frontline combination study in the first half of 2025.

T.J. Val: Hello, my name is T.J. Val, our collaborator expects to read out, randomized the phase 2 PFS data, combining U.E. and Tony Pellonet in the second half of the 2025.

Dr. Sean Foo: Our second program, Jeeva Stomach, is a bi-specific antibody that targets cloudically component to positive tumor cells, which conditionally activates T-cells via 4-1-BB, where cloud and 18.2 is expressed. We are developing Jeeva Stomach for the treatment of the first line gastric cancers as an add-on to the current standard of care. We expected to present updated data from our phase one monotherapy dose expansion study at the European Society for Medical Oncology or ESMO 2020 for meeting in September. Our third program, Jeeva Stomach, is a bi-specific antibody designed to provide anti-PDL-1 and a 4-1-BB-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 ASMO 2024.

Speaker Change: Our second program, G-R-Someg, is a bi-specific antibody that targets cloudingly you can point to a positive tumor cells, which conditionally activates T-cells via full on BB, where clouding 8.0 is expressed.

Speaker Change: We are developing Jeba Stilmake for the treatment of a first-line gastric cancer as an add-on to the current stand of a pair.

Speaker Change: We expected to present updated data from our phase 1 monotherapy, those expansion study at the European Society for Medical Oncology or Asmr 2024 meeting in September.

Speaker Change: A third program, the RAGE Stomach, is a vice-specific antibody designed to provide anti-PDL-1 and a full-1BDDR than T-cell activation.

Speaker Change: It has been developed for cancers that are relapse only with fracturing to checkpoint inhibitors and recently presented a compelling early data at ASCO 2020-24.

Dr. Sean Foo: I'm optimistic about our portfolio; without early clinical data, our innovative clinical trial strategies and the strong tune driving these programs forward offer us the potential to achieve important clinical milestones over the next year and beyond.

Speaker Change: I'm optimistic about our portfolio, without early clinical data, or innovative clinical trial strategies, and the strong team driving these programs forward, offer us the potential to achieve important clinical milestones over the next year and beyond.

Dr. Philip Dennis: With that, I would like to turn the call over to Dr. Philip Venice, IMAP's Chief Medical Officer. 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 Ulye Ledlamab or Ulye for sure.

Speaker Change: With that, I would like to turn the call over to Dr. Philip Venice, IMF's chief medical officer.

Speaker Change: Hello.

Philip Venice: Thank you, Sean, and good morning, everyone.

Philip Venice: Over the next few minutes, I will review the recent progress in upcoming milestones of our clinical pipeline, starting with Ulylidlamab or Uly for sure.

Dr. Philip Dennis: Slide 7 begins this section on Ulye. Ulye targets CD73, which is the rate-emitting enzyme critical for converting AMP or adenosine monophosphate into the immunosuppressive metabolite adenosine. Walking CD73 allows anti-tumor immunity to proceed in the tumor micro-environment without the presence of an adenosine-induced immunological fog. We believe Ulye 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 A were created to show Ulye's mechanism of action and how Ulye is differentiated from other CD73 antibodies.

Speaker Change: Slide 7 begins a section on Uly.

Speaker Change: The only target CD-73, which is the rate-memitting enzyme, critical for converting AMP, or a Denizene monophosphate, into the immunosuppressive metabolite, a Denizene.

Speaker Change: Blocking CDC 73 allows anti-tumor immunity to proceed in the tumor microenvironment without the presence of an adenosine induced immunological fog.

Speaker Change: We believe, newly is differentiated given its superior pharmacokinetic properties versus other competitors.

Speaker Change: 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.

Speaker Change: The illustrations on slide A were created to show Ulysses mechanism of action, and how Ulysses differentiated from other CDC-73 antibodies.

Dr. Philip Dennis: CD73 is activated when it is in a closed confirmation. We believe that Ulye'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 Ulye binds to two adjacent CD73 dimers on the C-terminus, it doesn't exhibit the hook effect. In fact, our clinical studies show that this approach completely inhibits CD73 in a dose-dependent manner. In contrast, when looking at other compounds such as eplimat, 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.

Speaker Change: TV73 is activated when it is in a closed confirmation.

Speaker Change: We believe that you least differentiation comes from its ability to bind to the C terminus of the enzyme, to prevent the formation of the closed dimer.

Speaker Change: CD73 is a butterfly structure. It has two N-terminine and two C-terminine.

Speaker Change: Because one molecule of uly binds to two adjacent CD73 dimers on the C-termist, it doesn't exhibit the hook effect.

Speaker Change: In fact, our three clinical studies show that this approach completely inhibits CDC-73 in the dose-dependent manner.

Speaker Change: In contrast

Speaker Change: When looking at other compounds such as a Leclamat, which binds to the end terminus of CD73.

Operator: This time, all participants are in listen only mode. The question and answer session will follow the formal presentation. If you'd 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.

Speaker Change: 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 n terminal binding sites with single valency.

Dr. Philip Dennis: Therefore, intermolecular bonds are not formed as readily at high concentrations as at lower concentrations. An inhibition of CD73 is paradoxically less at higher concentrations than at lower concentrations.

Speaker Change: Therefore, intermolecular bonds are not formed as readily at high concentrations as at lower concentrations. An inhibition of CDC-73 is paradoxically less at higher concentrations than at lower concentrations.

Dr. Philip Dennis: This is not observed with Ulye in preclinical model systems. During this call, I will walk you through the three studies from the Ulye program. The 2020-23 show that patients who at high CD73 expression and a PDO-1 TPS score of greater than or equal to 1% experience an objective response rate or ORR of 63%. Patients with lower levels of CD73 expression had a lower RR. The RR and the CD73 high group is higher than that observed in Keynote 42, which tested Pemberlism at monotherapy in the same disease setting and with the same distribution of PDO1 expression.

Operator: I'll now hand the call to over to Tyler and vice president of Vest Relations. Tyler, you may now begin your presentation.

Speaker Change: This is not observed with Uly in pre-clinical model systems.

Tyler: Thank you, operator, and welcome everyone to I-Mab via Pharma's first half 2020 for financial results and corporate update conference call. This morning, I'm at 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.

Speaker Change: During this call, I will walk you through the three studies from the UV program.

Speaker Change: The first study is outlined on slide 9.

Speaker Change: Data from this study presented at ASCO 2023.

Speaker Change: Show the patients who had high CD73 expression, and a PDL1 TPS score of greater than or equal to 1%. The experience and objective response rate, or ORR, of 63%.

Tyler: Before we begin, I would like to remind everyone that statements majoring with conference call will include forward-looking statements under the safe harbor provisions of the Private Security's 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.

Speaker Change: Patients with lower levels of CD 73 expression at a lower ORR.

Speaker Change: The ORR and the CDC 73-5 group is higher than that observed in Keynote 42, which tested Pembrollism at Monotherapy in the same disease setting and with the same distribution of PDO1 expression.

Dr. Philip Dennis: These data suggest that tumors with high levels of CD73 expression will respond best to you early. In addition to providing important proof of concept data, this study also shows that the combination was well tolerated. Two thirds of metastatic non-small cell lung cancer patients have tumors that express PDO1 and less than 50% of cells. For them, the standard of care is a checkpoint inhibitor or I-O combined with chemotherapy.

Lee: These data suggest that tumors with high levels of CDC-73 expression will respond best to you, Lee.

Tyler: 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 will be not guaranteed the accuracy or completeness of such information.

Lee: In addition to providing important proof of concept data, this study also shows that the combination was well tolerated.

Lee: 2-thirds of metastatic non-small cell lung cancer patients have tumors that express pdr-1 and less than 50% of cells.

Lee: For them, the standard of care is a checkpoint inhibitor, or I-O, combined with chemotherapy.

Dr. Philip Dennis: On slide 10, we outline the clinical rationale for a combination study that will include U-E plus I-O plus chemotherapy. First, the addition of chemotherapy to I-O monotherapy has extended the benefit of I-O to patients whose tumors express low levels of PDO1. Second, U-E has a favorable toxicity profile that suggests that the four-drop combination could be tolerated. Third, published data show that chemotherapy can induce CD73 expression, which could increase the likelihood of response to U-E. Ultimately, non-small cell lung cancer is one of the most common and deadly cancer diagnoses globally, and we believe that U-E has a potential to improve upon currently available standard of care, whether that standard of care is I-O monotherapy or I-O plus chemotherapy.

Tyler: 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 intended source has verified such assumptions.

Lee: On slide 10, we outline the clinical rationale for a combination study that will include U-E, plus I-O, plus chemotherapy.

Lee: First, the addition of chemotherapy to IOMonotherapy from extended the benefit of IOD patients whose tumors expressed low levels of PDO1.

Speaker Change: Second, you only has a favorable toxicity profile that suggests that the four-drug combination could be tolerated.

Tyler: 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 filing.

Speaker Change: 3. Public data show that chemotherapy can induce CDC-73 expression, which could increase the likelihood of response to uly.

Dr. Sean Foo: With that, I'll now turn the call over to Dr. Sean Foo, 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 IMF. 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 developers. For this morning's call, I will make a few opening remarks regarding our strategic milestones, organization and pipeline.

Speaker Change: Ultimately, non-small cell lung cancer is one of the most common and deadly cancer diagnoses globally. And we believe that Uly has a potential to improve upon currently available standard of care.

Speaker Change: Whether that's standard of care is IOM monotherapy or IOM plus chemotherapy.

Dr. Philip Dennis: I-MAP has received FDA clearance to proceed with the study of U-E plus Pembro plus chemotherapy, and we expect it does the first patient in the first half of 2025.

Speaker Change: I'm Amp has received FDA clearance to proceed with the study of U.V. Plus Pembrold plus chemotherapy and we expect to dose the first patient in the first half of 2025.

Dr. Philip Dennis: In the previous slide, we laid out the rationale for the four-drop combination study. This is an important study because we believe it could help define the regulatory path for U-E 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 I-O plus chemo standard of care and is designed to evaluate two different U-E 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 PDO1 expression.

Dr. Sean Foo: After that, Dr. Philip Dennis, our chief medical officer, will provide an update on our three differentiated immunoncology therapeutic programs with upcoming milestones.

Speaker Change: In the previous slide, we laid out the rationale for the Ford Drug Combination Study.

Speaker Change: This is an important study because we believe it could help to find the regulatory path for you and the future.

Dr. Sean Foo: And next, Joel Skeleton, our chief financial officer, will run through a few key financial items, including a review of our cash balance and runway.

Speaker Change: We intend to enroll patients who are eligible for first-line treatment of locally advanced or metastatic non-small cell lung cancer.

Dr. Sean Foo: I'll wrap up with a few closing remarks, and we'll open the call for questions.

Speaker Change: The study is randomized against IELP's chemo standard of care and is designed to evaluate two different ulydose levels.

Dr. Sean Foo: 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.

Speaker Change: Importantly, CDC-73 expression will be assessed retrospectively.

Speaker Change: The primary endpoint is objective response rate with standard secondary endpoints of progression freeze survival, duration of response, and overall survival, all stratified by PDO1 expression.

Dr. Philip Dennis: 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-to-1 ratio against standard of care, assessing U-E with two different dose levels.

Speaker Change: This study includes a small dose escalation lead in with an N equals to six.

Dr. Sean Foo: I'd like to share some of our notable accomplishments from the first half of this year. First was the divestiture of operations in China, announced earlier this year on April the 2nd. We established a new operating model as a US-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 a redemption obligation. We have efficiently worked to streamline our organization and build a new US-based leadership team, which includes the addition of Joe as CFO and Philip as CMO.

Speaker Change: Dosing is expected to begin in the first half of 2025.

Speaker Change: One safety is assessed in the lead-in patients will be randomized in a two-to-one ratio against standard of care, assessing uly with two different dose levels.

Dr. Philip Dennis: 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 dose in the randomized phase two 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.

Speaker Change: In this slide, it's, we believe it's important to share not only you leave upcoming milestones, but the adenosine pathway as a whole, given its promise in the immuno oncology space.

Speaker Change: We have prepared this chart to put the upcoming clinical milestones for usually into context with other CDC-73 programs.

Speaker Change: On the top of the chart, we have summarized three milestones for the ongoing and planned studies in our program, including the first patient dose in the Renitomized Phase 2 study of ULE plus Pembro, plus chemo I just described.

Dr. Sean Foo: From a corporate governance perspective, we successfully transitioned to having PWC US as our corporate auditor. As you will hear from Philip, we have significantly advanced our three oncology programs. We are squarely focused on execution and believe we're 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.

Speaker Change: We expect to be able to provide a readout from this study in the second half of 2021.

Dr. Philip Dennis: Additionally, we highlight upcoming progression-free survival or PFS data from the Uli plus TORI Paloma randomized phase two study ongoing in China only in the second half of 2025. This study is being conducted by our collaborator in China, T.J. Bio, who holds the right to Uli in China. On the bottom of the chart, we summarize expected phase one, two 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.

Speaker Change: Additionally, we highlight upcoming progression-free survival or PFS data from the U.E. plus Tori Palamab Randomized Phase 2 study ongoing in China only in the second half of 2025. This study is being conducted by our collaborator and China, TJ Biow, who holds the right to U.L. in China.

Dr. Sean Foo: Moving to slide five. Establishing and experience the US-based management team is critical to IMAP'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 was a focus on immunology oncology. Identifying and completing strategic transactions, raising capitals, and building successful organizations. In my experience, these are some of the core competencies for successful bottom-up companies today. Our leadership team exemplifies these core competencies. Our collective professional experiences and stellar track records is one of IMAP's most important strategic competitiveness.

Speaker Change: On the bottom of the chart, we summarized expected phase 1, 2 milestones for four other CDC-73 programs.

Speaker Change: We believe that positive results from other programs will help further validate the identifying pathway, specifically CD-73's a target, and that are approach for patient selection using CD-73 expression.

Speaker Change: As well as ULAs ability to completely inhibit CDC-73 could represent a differentiated advantage.

Dr. Philip Dennis: Next, I'd like to turn to Jeva Stelmeg on slide 13. Jeva Stelmeg or Jeva is a bi-specific antibody that is designed to target an 18.2, a tumor-associated antigen found in solid tumors, especially gastric cancers. The bi-specific antibody combines the Claude and 18.2 binding domain, where Claude and 18.2 is expressed, and 4-1BB, which conditionally activates T cells in the tumor microenvironment. Moreover, we believe Jeva is differentiated by a stability to bind to Claude and 18.2, even in tumors with very low levels of 18.2 expression. Slide 14 provides an opportunity to highlight Jeva's bi-specific design properties and the monotherapy data that may position it as a best-in-class Claude, 18.2, 4-1BB bi-specific antibody.

Speaker Change: Next, I'd like to turn to Jevastel McGunswide 13.

Speaker Change: Gita Stelma Gorgiva is a bi-specific antibody that is designed to target flood in 18.2. A tumor associated anagent found in solid tumors, especially gastric cancers.

Dr. Sean Foo: I'm pleased to introduce you to the I-Mab leadership team, including our new CMO, Philip Denner. Philip is a renowned lung cancer expert with broad clinical development expertise across a range of therapeutic modalities. With over 10 years of a big format, focus on immunoncology, antibody conjugates, and target therapies.

Speaker Change: The Vice-Pacific antibody combines the Claude in 18.2 binding domain, where Claude in 18.2 is expressed, and 4-1BB, which conditionally activates T-cells in the tumor microenvironment.

Speaker Change: Moreover, we believe Giva is differentiated by a stability to bind to cloud 18.2, even in tumors with very low levels of 18.2 expression.

Dr. Sean Foo: Our CFO, Jill 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 Shrewd, playing 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.

Speaker Change: Slide 14 provides an opportunity to highlight Giva's by-specific design properties and the monotherapy data that may position it as a best-in-class Quad 18.2 4-1bb by-specific antibody

Dr. Philip Dennis: Initial phase 1 monotherapy data reported at the ESMO 2023 meeting showed encouraging monotherapy results in patients with gastric cancers whose tumors have progressed or will refractory, including those with low levels of Claude and 18.2 expression. Based on the data from the phase 1 monotherapy results, we initiated a combination study of Jeva plus nivolumab plus chemotherapy in the first half of 2024. Crystal Myers-Flib is supplying the volumab under a clinical collaboration and supply agreement. Topline data from the study are expected to read out in the second half of 2025. In the meantime, I'm at plans to present new topline data from the Phase 1 Monotherapy Dose Expansion Study in patients with gastrocancerative disease that has progressed after previous treatment at ESMO 2024.

Speaker Change: Initial Phase 1 monotherapy data reported at the ESMO 2023 meeting.

Dr. Sean Foo: 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 six, our pipeline includes three oncology programs, folks on providing meaningful therapeutic options, the cancer patients with significant on-them medical means. All of these assets are commercially attracted, supported by code development and clinical supply agreements with spiritual Mars with TJ-Vile and AVL-Vile. Our lead program, U.L.E.Mab, is an antibody that targets C-G73.

Speaker Change: Showed encouraging monotherapy results and patients with gastric cancers whose tumors have progressed or will refractory including those with low levels of potten 18.2 expression.

Speaker Change: Based on the data from the phase one monotherapy results, we initiated a combination study of Giva plus Nevolumab plus chemotherapy in the first half of 2024.

Bristol Myers-Fuib: Bristol Myers-Fuib is supplying the volumav under a clinical collaboration in supply agreements.

Bristol Myers-Fuib: Top line data from the study are expected to read out in the second half of 2025.

Dr. Sean Foo: We're 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-Vile, our collaborator, expects to lead out, randomize the phase two PFS data, combining U.L.E, and Toli-Palimab in the second half of 2025. Our second program, Jeeva Stomach, is a bi-specific antibody that targets cloudically component to positive tumor cells, which conditionally activates T-cells via 4-1-BB, where cloud and 18.2 is expressed.

Bristol Myers-Fuib: In the meantime, I'm at plants to present new top-line data from the Phase 1 monotherapy dose expansion study in patients with gastric cancer since disease has progressed at the previous treatment at ESMO 2024.

Dr. Philip Dennis: Moving to slide 15, investors often ask about other cloud and 18.2 programs in development and how JIVA compares to Zolba Tuxamab or Zolby. In response, we have prepared this comparative slide. On the left slide of the chart, we have summarized several parameters from the JIVA Phase 1 monotherapy data presented at ESMO 2023 related to cloud and 18.2 expression and clinical outcomes. On the right-handed columns, we summarize, publish Phase 1 data and Phase 2 data from Zolby. While the table does not represent data from a head-to-head study, I believe it highlights the strength and potential differentiation of JIVA.

Speaker Change: Moving to slide 15, investors often ask about other cloud and 18.2 programs in development and how Giva compares to Zolda Tuxamap or Zolby.

Speaker Change: And response, we have prepared this comparative slide.

Speaker Change: On the left side of the chart, we have summarized several parameters from the Geva phase 1 monotherapy data presented at as much 2023 related to Claude in 18.2 expression and clinical outcomes.

Dr. Sean Foo: We are developing Jeeva Stomach for the treatment of the first line gastric cancers as an add-on to the current standard of care. We expected to present updated data from our phase one monotherapy dose expansion study at the European Society for Medical Oncology or ASMO 2020 for meeting in September. Our third program, Jeeva Stomach, is a bi-specific antibody designed to provide anti-PDL-1 and a 4-1-BB-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 ASMO 2024.

Speaker Change: On the right-handed columns, we summarize published phase one data and phase two data from Zolby.

Speaker Change: Well, the table does not represent data from a head-to-head study. I believe it highlights the strength of potential differentiation of G-Eva.

Dr. Philip Dennis: This data highlights JIVA's ability to treat patients even with low levels of cloud and 18.2 expression. For example, Zolby did not show a response in its Phase 1 study when cloud and 18.2 were expressed at 1 plus or greater than at least 1% of cells. When cloud and 18.2 parameters were tightened to 2 plus or greater staining in 50% of cells, Zolby monotherapy results appeared inferior to JIVA monotherapy results. These data support our view that JIVA has best-in-class potential and could be combined with frontline standard of care, NIVA plus chemo, and gastric cancer.

Speaker Change: This data highlights jiva's ability to treat patients even with low levels of cotton 18.2 expression.

Speaker Change: For example, Zoby did not show a response in its phase one study when Claude in 18.2 was expressed at one plus or greater than at least 1% of cells.

Dr. Sean Foo: I'm optimistic about our portfolio, with our early clinical data, our innovative clinical trial strategies, and the strong team driving these programs forward offer us the potential to achieve important clinical milestones over the next year and beyond.

Speaker Change: When Claude May point two parameters were tightened to two plus or greater staining in 50 percent of cells, Zolby monotherapy results appeared in area to diva monotherapy results.

Dr. Philip Dennis: With that, I would like to turn the call over to Dr. Philip Venice, IMAP's Chief Medical Officer. Thank you, Sean, and good morning everyone. Over the next few minutes, I will review the recent progress in upcoming milestones of our clinical pipeline, starting with Uly-Led Lamab or Uly for sure.

Speaker Change: These data support our view that Giva has best in class potential and could be combined with frontline standard of care, level plus chemo and gastrocancer.

Dr. Philip Dennis: Lastly, I'd like to turn to Roger Stomach on slide 16. Roger Stomach or Roger is a bi-specific antibody in development to treat advanced cell tumors that are refractory to checkpoint inhibitors. The bi-specific antibody was designed to provide anti-PDL-1 activity and 4-1BB-driven T cell activation and a single molecule using the same 4-1BB technology design as JIVA. 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 agonists. Localized activation of 4-1BB in the tumor micro-environment is intended to enhance anti-tumor immunity and reinvigorate exhausted T cells while mitigating liver toxicity and systemic immune responses.

Speaker Change: Lastly, I'd like to turn to Roger Stomach on slide 16. Roger Stomach, or Roger, is a bi-specific antibody in development to treat advanced solid tumors that are refractory to checkpoint inhibitors.

Dr. Philip Dennis: Slide 7 begins this section on Uly. Uly targets CD-73, which is the rate-emitting enzyme critical for converting AMP or adenosine monophosphate into the immunosuppressive metabolite adenosine. Walking CD-73 allows anti-tumor immunity to proceed in the tumor micro-environment without the presence of an adenosine-induced immunological fog. We believe Uly is differentiated given its superior pharmacokinetic properties versus other competitors, as demonstrated by its ability to completely inhibit CD-73 activity without the hook effect that has been described for other drugs that target CD-73 and may prevent them from achieving maximal inhibition of CD-73.

Speaker Change: The bi-specific antibody was designed to provide anti-PDL1 activity and 4-1BB driven T cell activation and the single molecule using the same 4-1BB technology design as GIVA.

Speaker Change: The combination of an F.C. silent antibody with conditional 4-1 BB engagement is intended to optimize the compound for safety, including the potential for lower hepatotoxicity compared to a traditional 4-1 BB Agons.

Speaker Change: Localized activation of 4-1BB and the tumor microenvironment is intended to enhance anti-tumor immunity and reinvigorate exhausted T cells while mitigating liver toxicity and systemic immune responses.

Dr. Philip Dennis: Slide 17 provides a snapshot of early phase-1 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 valuable at the time of the presentation. The majority of patients had at least three prior lines of treatment. Top line phase one results demonstrated an ORR of 27 percent, including six partial responses, one complete response, and a clinical benefit ratio of 69 percent. 71 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.

Speaker Change: Slide 17 provides a snapshot of early phase 1 dose escalation and dose expansion data presented at the end of the year.

Dr. Philip Dennis: The illustrations on slide 8 were created to show Uly's mechanism of action and how Uly is differentiated from other CD-73 antibodies. CD-73 is activated when it is in a closed confirmation. We believe that Uly's differentiation comes from its ability to bind to the C-terminus of the enzyme to prevent the formation of the closed dimer. CD-73 is a butterfly structure. It has two N-termini and two C-termini. Because one molecule of Uly binds to two adjacent CD-73 dimers on the C-terminus, it doesn't exhibit the hook effect.

Speaker Change: The study enrolled 53 patients with advanced or relapse solid tumors. 44 of whom were valuable at the time of the presentation.

Speaker Change: The majority of patients had at least three prior lines of treatment.

Speaker Change: Top line phase one results demonstrated in ORR of 27% including six partial responses, one completely response, and a clinical benefit ratio of 69%.

Speaker Change: 71% of patients who responded have received prior checkpoint and debuts.

Dr. Philip Dennis: In fact, our clinical studies show that this approach completely inhibits CD-73 in a dose-dependent manner. In contrast, when looking at other compounds such as electromat, which binds to the N-terminus of CD-73, 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 N-termininal binding sites with single valency. Therefore, intermolecular bonds are not formed as readily at high concentrations as at lower concentrations. An inhibition of CD-73 is paradoxically less at higher concentrations than at lower concentrations.

Speaker Change: The complete response was observed in a heavily-pre-treated ovarian cancer patient who had received seven prior lines of therapy.

Dr. Philip Dennis: We are encouraged by the results from the study because of the early clinical signs of efficacy; enrollment and selected indications and different dose schedules is ongoing.

Speaker Change: We are encouraged by the results from the study because of the early clinical signs of efficacy.

Speaker Change: Enrollment and selected indications and different those schedules is ongoing.

Dr. Philip Dennis: Slide 18 provides a snapshot of the safety profile, while increased liver enzymes were the most common treatment-emergent adverse event. None of the transaminase elevations were accompanied by increases in bilirubin, the so-called high's law. Paces with grade three increases in liver enzymes improved with cortical treatment, corticostero treatment, and no cytokine release syndrome was reported. The combination of Rajee's early efficacy and manageable safety profile is encouraging, and enrollment in the phase one study continues.

Speaker Change: Slide 18 provides a snapshot of the safety profile. While increased liver enzymes were the most common treatment emergent adverse event.

Speaker Change: None of the transaminated elevations were accompanied by increases in Billy Rubin, the so-called high-slaw.

Speaker Change: Paces with grade 3 increases in liver enzymes improve the cortical treatment, corticoceroatreatment, and no side of kinrelease syndrome was reported.

Speaker Change: The combination of Raj's early efficacy and manageable safety profile is encouraging an enrollment and the phase one study continues.

Dr. Philip Dennis: This is not observed with Uly in preclinical model systems. During this call, I will walk you through the three studies from the Uly program. The first study is outlined on slide 9. Data from this study presented at ASCO 2023 show that patients who at high CD-73 expression and the PD-01 TPS score of greater than or equal to 1%, experience an objective response rate or ORR of 63%, patients with lower levels of CD73 expression had a lower RR.

Dr. Philip Dennis: Slide 19 provides a recap of the pipeline. In summary, we are encouraged by the early clinical data for Uly, Jeeva, and Rajee. 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 one dose expansion monotherapy data.

Speaker Change: Lyd 9 team provides a recap of the pipeline.

Speaker Change: In summary, we are encouraged by the early clinical data for Uli, Jiva and Raji.

Speaker Change: We believe that each agent has a unique and differentiated mechanism of action and a manageable safety profile.

Speaker Change: We are excited to be on the cusp of clinical milestones for each program, including an upcoming data release at asthma 2024, where we will share phase 1 dose expansion in monotherapy data.

Jill Skelton: Now I will hand the call over to Jill for the financial overview.

Speaker Change: Now I will hand the call over to Joe for the financial overview.

Jill Skelton: Thank you, Philip. 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 IMF has executed on the board's vision and made significant strategic and corporate development progress in 2024. I will touch briefly on 5 key corporate parameters that we believe are strategically important for IMF. First, we extinguished $200 million of a $215 million redemption obligation.

Dr. Philip Dennis: The RR and the CD73 high group is higher than that observed in keynote 42, which tested Pembrolyzumab monotherapy in the same disease setting and with the same distribution of PDO1 expression. These data just suggest that tumors with high levels of CD73 expression will respond best to you, Lee. In addition to providing important proof of concept data, this study also shows that the combination was well tolerated. Two-thirds of metastatic non-small cell lung cancer patients have tumors that express PDO1 and less than 50% of cells. For them, the standard of care is a checkpoint inhibitor or I-O combined with chemotherapy.

Joe Skeleton: 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 US dollars.

Speaker Change: As you begin to talk about the financials, I want to echo Sean's opening comments that IMAV has executed on the board's vision and made significant strategic and corporate development progress in 2024.

Speaker Change: I'll touch briefly on five key corporate parameters that we believe are strategically important for IMF.

Speaker Change: First.

Speaker Change: We extinguished 200 million of a $215 million redemption obligation.

Jill Skelton: $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.

Speaker Change: 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.

Dr. Philip Dennis: On slide 10, we outline the clinical rationale for a combination study that will include you, Lee plus I-O plus chemotherapy. First, the addition of chemotherapy to I-O monotherapy has extended the benefit of I-O to patients whose tumors express low levels of PDO1. Second, Lee has a favorable toxicity profile that suggests that the four-drop combination could be tolerated. Third, published data show that chemotherapy can induce CD73 expression which could increase the likelihood of response to you, Lee.

Jill Skelton: Second, we streamline the pipeline. We are advancing OULE into Phase Two in the U.S. and are continuing to advance Chief of 3D ongoing phase one B. With the divestiture of the China operations, two phase three trials shifted to TJ buyer. Those are the mad and FK and so on the trope it out. Sarah, we strengthen the Juva Clinical Program through a clinical trial, collaboration, and supply agreement with Bristol-Myers Squibb. The MF is supplying the volumpt for the triple combination study, evaluating Juva Stilman's in combination with chemotherapy and the volumpt. The standard of care in frontline gastric cancer.

Speaker Change: 2nd, we streamline the pipeline. We are advancing our lead into phase 2 in the U.S. and our continuing to advance Chiba through the ongoing phase 1B.

Speaker Change: with the divest picture of the China operations to face three trials shifted to TJ buyer. Those are the math and F10, so I'm a children alpha.

Speaker Change: Here, we strengthen the Geeta Clinical Program through a clinical trial, collaboration, and supply treatment with Prisma IRSWIP.

Speaker Change: The MS is supplying the volemask for the triple combination study, evaluating GVS domain, in combination with chemotherapy and the volemask, the standard of count and frontline gastric cancer.

Dr. Philip Dennis: Ultimately, non-small cell lung cancer is one of the most common and deadly cancer diagnoses globally and we believe that you Lee has a potential to improve upon currently available standard of care, whether that standard of care is I-O monotherapy or I-O plus chemotherapy. I-MAP has received FDA clearance to proceed with the study of U-League plus Pembro plus chemotherapy and we expected dose the first patient in the first half of 2025. In the previous slide, we laid out the rationale for the four-drop combination study.

Jill Skelton: Fourth, we optimize the workforce by streamlining from 220 XTEs at year end to 34, June 30th. We've also shifted the organization so that the full senior leadership team is based in the US and the workforce is primarily based in the US.

Speaker Change: 4. We optimize the workforce by streamlining from 220 XTEs at year end to 34 at June 30.

Speaker Change: 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.

Jill Skelton: And lastly, we engage U.S. auditors. Earlier this month, we announced that we had appointed PwC US as our financial auditors.

Speaker Change: And lastly, we engage viewers' auditors. Earlier this month, we announced that we have pointed TWC, US, as our financial auditors.

Jill Skelton: 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. And as of June 30th, my as-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 vested IMAP Shanghai entity to settle working capital obligations.

Speaker Change: As we move to fly 21, I would like to take you through a Proform at Cashwalk, using our last reported cash balance and review our cash runway expectations.

Dr. Philip Dennis: This is an important study because we believe it could help define the regulatory path for U-League 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 I-O plus PEMO standard of care and is designed to evaluate two different U-League 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 PDO1 expression. The 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.

Speaker Change: 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 31st, 2023 with 321.8 million.

Speaker Change: And as of June 30, I'm that reporting cash balance was 207.5 million.

Speaker Change: The Delta of a 114.3 million is comprised of cash outflows across five major buckets, partially offset by inflows in the second quarter.

Mary: I'm Mary.

Mary: 10.8 million of the cash reported at 1231-2023 remained with a invested IMAP Shanghai entity to settle working capital obligations. The consistent with ASC205-20 accounting treatment was the cash into discontinued operations.

Jill Skelton: The 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 ASC are related to arbitration with the dissenting shareholder, which has been subsequently settled. Foreign exchange losses incurred on the transfer of REM and B to US 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 of the IMAP group pre-closing of the divestiture.

Dr. Philip Dennis: Once safety is assessed in the lead-in, patients will be randomized in a 2-to-1 ratio against standard of care, assessing U-League with two different dose levels, in this slide it's we believe it's important to share not only Uly's upcoming milestones but the adenosine pathway as a whole given its promise in the immunoncology space. We have prepared this chart to put the upcoming clinical milestones for Uly 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 dose in the randomized phase two study of Uly plus Pembro plus chemo I just described.

Mary: Bringing the comparative year and cash balance to 311 million.

Mary: Item B. In the first quarter of 2024, 47.8 million in outflows were incurred related to the devastature of China operations, including 19 million for our Series C investment in TJ Biopharma.

Dr. Philip Dennis: We expect to be able to provide a readout from this study in the second half of 2026. Additionally we highlight upcoming progression brief survival or PFS data from the Uly plus Tory Paloma randomized phase two study ongoing in China only in the second half of 2025. This study is being conducted by our collaborator in China, DJ Bio, who holds the right to Uly and China. On the bottom of the chart we summarize expected phase one two milestones for four other CD73 programs.

Mary: 17 and a half million placed into Oscar related to arbitration with a dissenting shareholder, which has been subsequently settled. 4x change losses incurred on the transfer of REM&B to US dollars, and other non-recurring expenditures associated with the disaster.

Mary: Item C. During the first quarter, there were 47.1 million in consolidated operating expenses of the IMAB Group pre-closing of the debaustature.

Jill Skelton: 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 IMAP 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.

Mary: Item B and the second quarter there were 1.6 million in additional non-requering expenses incurred associated with the debustiture.

Mary: In the second quarter, there were 12.1 million in operating expenses of IMAB at the stand-alone entity.

Mary: Of mode, there were also cash inflows of 5.1 million. A tribute to the return of a deposit to support a shared buy-back program, which the company Melongra anticipates renewing, and interest income earned during the second quarter of 2024.

Dr. Philip Dennis: 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 Uly's ability to completely inhibit CD73 could represent a differentiated advantage.

Speaker Change: Looking ahead, we believe that they, on our current operating plans, are cash runway will take us into 2027, including several important clinical milestones.

Jill Skelton: Moving to slide 22, we have provided a summary of selective financial information and upcoming milestones to recap on the financials. Our cash and cash equivalents and short-term investments work 207.5 million out of June 30th, 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 Idiotes.

Speaker Change: Moving to slide 22, we have provided a summary of selected financial information and upcoming milestones.

Speaker Change: To recap on the financials. Our cash and cash equivalents and short-term investments work 207.5 million as of June 30, 2024.

Dr. Philip Dennis: Next, I'd like to turn to Jeva Stelmeg on slide 13. Jeva Stelmeg or Jeva is a bi-specific antibody that is designed to target Claude in 18.2. A tumor associated antigen found in solid tumors, especially gastric cancers. The bi-specific antibody combines the Claude in 18.2 binding domain where Claude in 18.2 is expressed and 401BB which conditionally activates T cells in the tumor microenvironment. Moreover, we believe Jeva is differentiated by a stability to bind to Claude in 18.2, even in tumors with very low levels of 18.2 expression.

Speaker Change: We believe based on our current operating plans that our cash runway will take us into 2027, including several clinical milestones.

Speaker Change: Our issued an outstanding ordinary shares represented in the equivalent of 81.4 million

Dr. Sean Foo: Now, I'd like to turn the call back to Sean to wrap up.

Speaker Change: Now, I'd like to turn the call back to Sean to Rapa.

Dr. Sean Foo: 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 to each Ojiva and Eulie. Ojiva, we expected to present updated Phase One 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 Eulie, we expected 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.

Sean Foo: Thank you, Joe.

Sean Foo: As we get ready to take your questions, I'd like to summarize the companies upcoming milestones and make a few closing comments.

Sean Foo: First, we've mapped out four upcoming milestones to each or Jiva and a U-Link. For Jiva, we expect it to present updated phase 1 dose expansion data at the Esmo 2024 meeting.

Dr. Philip Dennis: Slide 14 provides an opportunity to highlight Jeva's bi-specific design properties and the monotherapy data that may position it as a best-in-class Claude in 18.2 401BB by a specific 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 will refractory, including those with low levels of Claude in 18.2 expression. Based on the data from the Phase I monotherapy results, we initiated a combination study of Jeva plus Nevolumab plus chemotherapy in the first half of 2024. Crystal Myers-Philip is supplying the volumab under a clinical collaboration and supply agreement. Top line data from the study are expected to read out in the second half of 2025.

Sean Foo: And we expected to provide top-line data from the GEVA combo study in gastric cancers in the second half of 2025.

Sean Foo: for you, Lee.

Sean Foo: We expected 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.

Dr. Sean Foo: And we expected to provide top-line progression-free survival data from the randomized to phase two study conducted by our collaborator, TJ Violet, in the second half of 2025.

Sean Foo: And we expect it to provide coplanid progression-free survival data from the randomized interface to steady, conducted by our collaborator, TJ Biola in the second half of 2025.

Dr. Sean Foo: As we conclude today's prepared remarks, I'd like to leave you with these key messages. IMAP is exclusively focused on the development of defensuated immunotherapies for cancer. 2024 has been transformational for IMAP, with the divestiture of operations in China announced on April 2nd. 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. Building a new U.S.-based leadership team and completed the key governance and corporate development milestones.

Sean Foo: As we conclude today's prepared remarks, I'd like to leave you with these key messages.

Speaker Change: Hi, Matt is exclusively focused on the development of differentiated immunotherapies for cancer.

Speaker Change: 2024 has been transformational for IMAP, with the divestiture of operations in China announced on April 2nd, we established a new operating model at the US-based global delta company.

Speaker Change: Thanks to the excellent contributions by everyone in our organization, we are executing on the Board's strategic vision.

Dr. Philip Dennis: In the meantime, I'm at plans to present new top line data from the Phase 1 Monotherapy Dose Expansion Study in patients with gastrocancerative disease has progressed after previous treatment at Esmo 2024.

Speaker Change: We have significantly advanced our three oncology programs and worked efficiently to streamline our organization, building U.S. based the leadership team and a complete and key governance and corporate development milestones.

Dr. Sean Foo: 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 a leadership team, and strong cash balance position will let us to make meaningful progress in the second half of 2024 and beyond.

Dr. Philip Dennis: Moving to slide 15, investors often ask about other cloud and 18.2 programs in development and how JIVA compares to Zolba Tuxamab or Zolby. In response, we have prepared this comparative slide. On the left slide of the chart, we have summarized several parameters from the JIVA Phase 1 Monotherapy Data presented at Esmo 2023 related to cloud and 18.2 expression and clinical outcomes. On the right-handed columns, we summarized Publish Phase 1 Data and Phase 2 Data from Zolby.

Speaker Change: As we look forward, we will continue to think strategically to evaluate new opportunities to furthering has our pipeline.

Speaker Change: We are squarely focused on execution, and we believe that combination of our differentiated pipeline experienced leadership team and strong cash balance position will let us to make a meaningful progress in the second half of the 2024 and beyond.

Dr. Sean Foo: 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.

Speaker Change: Now I would like to thank everyone for listening to our call and ask the operator to please open the call for questions.

Operator: Well, now we're conducting a question-and-answer session. If you'd like to ask a question at this time, you may press star one from your telephone keypad, and a confirmation tone will indicate your line's position 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 key. Please.

Dr. Philip Dennis: While the table does not represent data from a head-to-head study, I believe it highlights the strength and potential differentiation of JIVA. This data highlights JIVA's ability to treat patients even with low levels of cloud and 18.2 expression. For example, Zolby did not show a response in its Phase 1 study when cloud and 18.2 was expressed at one plus or greater than at least one percent of cells. When cloud and 8.2 parameters were tightened to two plus or greater staining in 50 percent of cells, Zolby Monotherapy results appeared inferior to DIVA Monotherapy results. These data support our view that JIVA has best in class potential and could be combined with frontline standard of care, NIVA plus chemo and gastric cancer.

Speaker Change: Thank you. Well now we can talk to you in the question and answer session.

Speaker Change: If you'd like to ask the question at this time, you may press star 1 from your telephone keypad and a confirmation tone to indicate your lines in the question queue. Let me press star 2, you'd like to withdraw your question from the queue.

Speaker Change: The participants are using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.

Operator: One moment, please. Will we pull for questions? And once again, that's Star One. Thank you.

Speaker Change: One roll please, so we pull off a question and once again that's star one. Thank you.

Joe Catanzaro: First question will be coming from the line of Joe Catanzaro with Piper Sandler. Please excuse your questions.

Speaker Change: Thank you. First question will be coming from the line of Joe Katanzaro with Piper Sandler. Please just use your questions.

Joe Catanzaro: Thank you, everybody. Thanks for taking my questions. Maybe I had a couple on give a stomeg. First one on the upcoming ESMO update. One of them, 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, appreciate the comparison to Zolba Talksabab. But wondering if you had any thoughts on how Giva maybe compares to the growing quad and 18.2 ADC landscape and where it could differentiate versus those programs. Thanks. Thank you for your question, Joe.

Joe Katanzaro: Hey, everybody. Thanks for taking my questions. Maybe I had a couple on give a still make first one on the upcoming asthma update. When I'm ready for you could just help sort of set expectations in terms of the data set we'll see patient numbers.

Speaker Change: And any new learnings around the monitor be profile there. And then second question, appreciate the comparison to Zulbatoxabab. But wondering if you had any thoughts on how give up maybe comparison to the...

Dr. Philip Dennis: Lastly, I'd like to turn to Roger Stomach on slide 16. Roger Stomach or Roger is a bi-specific antibody in development to treat advanced solid tumors that are refractory to checkpoint inhibitors. The bi-specific antibody was designed to provide anti-PDL1 activity and 4-1BB driven T-cell activation and a single molecule using the same 4-1BB technology designed as JIVA. 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 agonis.

Speaker Change: Growing, uh, caught in 18.2 ADC landscape and where it could differentiate versus those programs. Thanks.

Speaker Change: Thank you for your questions, Joe. Question.

Dr. Philip Dennis: We'll turn that question over to our Chief.

Speaker Change: We'll turn that button over to you. Our keypad.

Dr. Philip Dennis: I'm just going to say we'll turn that question over to our Chief Medical Officer, Dr. Phil Dennis. Thanks, Tyler. 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 explicit 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 regimen such as Volfox. And then I think that's that is the basis for the differentiation with other 18.2 targeted assets.

Tawa: Go ahead, Tawa.

Phil Benes: I'm just going to say we'll turn that question over to our Chief Medical Officer, Dr. Phil Benes.

Phil Benes: Thanks, Tyler, and thanks for the question. The data presented at Asmo again will be...

Phil Benes: data from the DOES Expansion Coal wards.

Speaker Change: with gastric cancer. This will be with approximately 30 patients. And the profile is, again, one of explicit safety. And again, a notable ORR.

Dr. Philip Dennis: 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-1 oscillation and does 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 a valuable at the time of the presentation. The majority of patients had at least three prior lines of treatment.

Speaker Change: But importantly, I think you raised an important question. The way we envision Jesus development is given its tolerability is to combine it with frontline therapy with the whole of the map and regimen such as full fox.

Speaker Change: And I think that's from that is the basis for the differentiation with other 18.2 targeted assets.

Dr. Philip Dennis: So 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 talks 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, the movement of 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 Volfox, for example.

Speaker Change: So

Speaker Change: While we know that ADC's 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.

Dr. Philip Dennis: Top line phase one 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 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. Enrollment and selected indications and different dose schedules is ongoing.

Speaker Change: Our ORR is inferior, but arguably our talks profile is much better suited for combination in frontline studies.

Speaker Change: And I think that's the differentiating feature. I think for an ADC targeting 18.2, the movement of 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.

Joe Catanzaro: 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.

Speaker Change: every drug that's in full box, for example, so I think that's a differentiating feature where we can be more readily combined with frontline therapy.

Dr. Philip Dennis: Slide 18 provides a snapshot of the safety profile. While increased liver enzymes were the most common treatment emergent adverse event, none of the transaminase elevations were accompanied by increases in billi-rooven, the so-called high's law. Paces with grade 3 increases in liver enzymes improved with cortical treatment, cortic or steroid treatment, and no cytokine-release syndrome was reported. The combination of Rajee's early efficacy and manageable safety profile is encouraging an enrollment in the phase one study continues.

Speaker Change: Ok, great and so helpful. Thanks for taking my questions.

Kelly C.: Our next questions come from the line of Kelly C. with Jeffries. This is your three questions.

Speaker Change: Our next question is going to come from the line of Kelly Sheet with Jeffries. Please do see you with your questions.

Kelly C.: Hi, this is Hansel Sue for Kelly Sue. Congrats on the progress in the first half of '24. I just have two quick questions. First, what is your target finished day for the transitioning to the US-based auditors? What should we think about expenses going forward split between US and China?

Speaker Change: Hi, this is Hansa Tsuchukali. She congrats on the progress in first half of 2004. I just have two quick questions.

Hansa Tsuchukali: First, what is your target finished day for the transitioning to the U.S. base auditors? What should we think about expenses going forward, split between U.S. and China?

Kelly C.: The second question is for the pipeline strategy as you're thinking about the expansion to your pipe, adding more assets to your pipeline. Are you still focusing on the oncology space or looking to expand to other therapeutic areas? Thank you.

Dr. Philip Dennis: Slide 19 provides a recap of the pipeline. In summary, we are encouraged by the early clinical data for Uly, Jeeva, and Rajee. We believe that each agent has a unique and differentiated mechanism of action and a manageable safety profile.

Speaker Change: The second question is for the pipeline strategy, as you're thinking about expansion to adding more assets to your pipeline, are you still focusing on oncology space or looking to expand to other therapeutic areas? Thank you.

Dr. Sean Foo: Thank you for your question, Kelly.

Dr. Sean Foo: Was it possible to repeat the first question, and we'll turn the question over to Sean, our interim CO, to answer? Sure. The first question is, what's your target finish day regarding the fully transitioning to a US-based auditor?

Speaker Change: Thank you for your question, Kelly. It was possible to repeat the first question and we'll turn the question over to Sean or in from CO to answer.

Dr. Philip Dennis: 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 one dose expansion monotherapy data.

Speaker Change: Sure, the first question is, what's your target finished day regarding the fully transitioning to a US-based auditor?

Joe Skeleton: Now I will hand the call over to Joe for the financial overview. Thank you, Philip. As we turn to slide 20, we are shifting the discussion to corporate development and finance.

Dr. Sean Foo: Thanks for that question. We have completed the transition, and PWC US 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 them earlier. The going burn rate will be considerably lower compared to what you saw in the first and second quarter of this year, because we have streamlined organization; we focus on clinical development programs going forward.

Speaker Change: Yeah, thanks for that question. We have completed the transition at PWC and U.S.

Speaker Change: is now our corporate auditor and have been working closely with them since the completion of the transition. So this is an important accomplishment.

Joe Skeleton: 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 IMAB has executed on the board's vision and made significant strategic and corporate development progress in 2024. I will touch briefly on five key corporate parameters that we believe are strategically important for IMAB. First, we extinguished $200 million of a $215 million redemption obligation.

Speaker Change: And together with other corporate developments after the diverseture, you can start to see the change in as a company how I map is allocating resources.

Speaker Change: 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 in second quarter this year because we have streamlined organization, we focus on clinical development programs.

Joe Skeleton: $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 OULE into phase two in the U.S, and are continuing to advance Chief of through the ongoing phase one B. With the divestiture of the China operations, two phase three trials shifted to T.J, buyer.

Dr. Sean Foo: 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 to modalities, we are also open for discussion and collaboration, but oncology is one area we obviously see synergy.

Speaker Change: going forward.

Speaker Change: And the other question you asked about the pipeline strategy, yes, we are actively looking.

Speaker Change: To further enhance our pipelines through external collaboration, licensing, opportunities. And obviously given that the 3SATS internally are all oncology folks, our team has significant oncology asset development.

Speaker Change: Experience that we are starting our reviews, our explorations.

Joe Skeleton: Those are IMAB and F-10, so I'm going to open out. Third, we strengthen the JIVA Clinical Program through a Clinical Trial Collaboration and Supply Agreement with Crystal Myers-Swip. The MF is supplying the Volumab for the Triple Combination Study, evaluating JIVA still met in combination with chemotherapy and the Volumab, the standard of care and frontline gastric cancer. Fourth, we optimize the workforce by streamlining from 220 XTEs at year end to 34 June 30th.

Speaker Change: in the oncology space. But we're not limiting ourselves just to oncology for adjacent to modalities. We are also open for discussion and a collaboration, but oncology is one area we obviously see synergy.

Dr. Sean Foo: And I think the final part of a question has to do with going forward with the pipeline strategy. We are squarely focused on execution of our internal pipeline to see that we explained in detail today by Phillips. And we're excited about these pipelines, so 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 IMAP in the next year.

Speaker Change: And I think that the final part of a question has to do with going forward the pipeline strategy. We are...

Speaker Change: Squarely Focus on Execution of our Internal Pipeline Distribute That We Are.

Speaker Change: That's it.

Joe Skeleton: 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 engage U.S, auditors. Earlier this month, we announced that we had appointed PWC U.S, as our financial auditors.

Speaker Change: It's explained in detail today.

Speaker Change: by Phillips and we're excited about these pipelines, so we're looking.

Speaker Change: To license in and I will look 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.

Joe Skeleton: 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. And as of June 30th, IMAP'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.

Speaker Change: Go for what we can expect it to bring a near-term value inflection for IMAP in the next year.

Dr. Sean Foo: Great. Thank you.

Speaker Change: Great, thank you.

Operator: As a reminder, if you'd like to ask a question, you may press star one from your telephone keypad.

Speaker Change: Thank you. As a reminder, if you'd like to ask a question, you may press star 1 from your telephone keypad.

Andre Smallbinotto: Our next question is from the line of Andre Smallbinotto with HC Wayne, right? Please just use your question. Hi. Thank you. Congratulations on the progress. Thank you for taking my question. Just two quick ones from me.

Speaker Change: Our next question is from the line of Andre Smaldenado with H.C. Wayne, right? Please receive their questions.

Andre Smaldenado: Hi, thank you for your congratulations on the progress, thank you for taking my question. Just two quick ones for me.

Andre Smallbinotto: For you, on the MAP combination study, could you talk a little bit about, you know, what you need to see on the advocacy front for this new study? And what are some of the external signals you're using to benchmark your goals, less no-go decisions?

Joe Skeleton: Item A, 10.8 million of the cash reported at 1231, 2023 remained with the vested IMAP 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 T.J. Biopharma, 17.5 million placed in to ask our related to arbitration with a dissenting shareholder, which has been subsequently settled, foreign exchange losses incurred on the transfer of Remind B to US dollars, and other non-recurring expenditures associated with the divestiture.

Speaker Change: For you, I'm in the next conversation, but could you talk a little bit about it?

Speaker Change: You know 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 ghost-less no-go decision? And then, as an added question, in the second half, the phase 2 PFS data from the DGA BIOS study just came on.

Dr. Philip Dennis: And then, as an additive question, in the second half, the phase two PFS data from the TJ Bio Study just keeps on, you know, how are you doing to leverage that data moving forward and what you need to see there? Thank you very much for taking my question. Thank you for a question, Andres.

Speaker Change: You know, how are you doing the leverage that data moving forward and what you need to see there? Thank you very much for taking my question.

Dr. Philip Dennis: I will direct your question to our Chief Medical Officer, Dr. Phil Dast. Thanks. And I will address the questions in order, and if I don't do so completely, please, I'll make sure to address all of them. In terms of benchmarks for efficacy in our, in our 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-1 expression. So basically, what we're looking for is clinically meaningful improvements, incremental improvements that are clinically meaningful over the standard care, Keynote 189. Moreover, in our proposed phase two, 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.

Speaker Change: Thank you for your question, Andreas. I will direct your question to our Chief Medical Officer, Dr. Phil Benes.

Phil Benes: Thanks, and I'm...

Phil Benes: I will address the questions in order and if I...

Speaker Change: Don't do so completely, please. Let's make sure to address all of them.

Speaker Change: In terms of

Speaker Change: Benchmarks for efficacy in our phase two. The sense is that the comparison is keynote 189, where we know the medium PFAS is about nine months.

Joe Skeleton: Item C, during the first quarter, there were 47.1 million in consolidated operating expenses of the IMAP 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 IMAP 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 buy-by program, which the company no longer anticipates renewing, and interest income earned during the second quarter of 2024.

Speaker Change: And we know the ORR can vary depending on the PDO1 expression. So basically what we're looking for is clinically meaningful improvements, incremental improvements that are clinically meaningful over the standard of care, key to 189.

Speaker Change: In our proposed phase 2, 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.

Dr. Philip Dennis: 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 identity pathway. And these studies include studies with ELECTLIMAT that is being developed by AstraZeneca in earlier stages of disease, resectable disease, stage three on resectable disease, excuse me, as well as antibodies against CD39 and small molecules. So we think that this will help, again, propel the field forward, give us confidence in youly in the pathway, and I think with the signal that we hope to see from our study, from our proposed study with Embro Quimo and with the TJ-Bio-Dublet study that is in the CD73 selected population, we will get support for our hypothesis that it's the patients that have five CD73 expression that benefit most from youly.

Speaker Change: Now, in terms of external benchmarks, as the slide showed, we're very interested in outcomes from competitor studies, because...

Speaker Change: positive outcomes from these competitor studies who really validate the identifying pathway. And these studies include studies with a lecle map.

Joe Skeleton: Looking ahead, we believe that based on our current operating plans, our cash runway will take us into 2027, including several important clinical milestones.

Speaker Change: That it's being developed by AstraZeneca and earlier stages of disease, resectable disease, stage 3 on resectable disease. Excuse me, as well as antibodies again, CD-30, 9 in small molecules. So we think that this will help.

Joe Skeleton: 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 work 207.5 million out 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 idiotes.

Speaker Change: Again propel the field forward.

Speaker Change: Give us confidence in newly in the pathway and I think with the signal that we hope to see from our study, from our proposed study, with Femro chemo, and with the T.J. I-O-Dublet Study, that is in the CDC-73 selected population.

Dr. Sean Foo: Now, I'd like to turn the call back to Sean to wrap up. Thank you, Joe.

Speaker Change: We will get support for our hypothesis that it's the patients that have 5 CDC-CD-73 expression that benefit most from Uly.

Dr. Sean Foo: 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 to each for GIVA and EULI. For GIVA, we expected to present updated phase one 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 EULI, we expected 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 expected to provide top-line progression-free survival data from the randomized to phase two study conducted by our collaborator, TJ Violet, in the second half of 2025.

Andre Smallbinotto: Great, thank you very much. Thank you.

Speaker Change: Great. Thank you very much.

Dr. Sean Foo: At this time, we have no additional questions, and I'll hand the call back to Dr. Sean Foufe for closing remarks. Great, thank you very much again for taking the time to join our call today, and so you can gather from the discussions and the presentations, we’re very excited about the pipeline, and if the team is dedicated to continue to push the pipeline forward in the most efficient and the scientific way, we look forward to updating you on our future progress, and if you have any follow-up questions, we reach out to Tyler Eller, our head of investor relationships.

Speaker Change: Thank you. At this time, we have no additional questions, and I'll hand the call back to Dr. Sean Foo for closing remarks.

Sean Foo: Great, thank you very much again for taking the time to join our call today and so you can gather from the discussions and the presentations were very excited about the pipeline and the team is dedicated to continue to push the pipeline forward in the most efficient and the scientific way.

Speaker Change: And we look forward to updating you on our teacher progress and if you have any follow-up questions, we reach out to Tyler Allen, our Head of Investor Relationships. Have a great day. You may now disconnect the call.

Dr. Sean Foo: Have a great day.

Operator: You may not disconnect the call.

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

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

Dr. Sean Foo: As we conclude today's prepared remarks, I'd like to leave you with these key messages. IMAP is exclusively focused on the development of defensuated immunotherapies for cancer. 2024 has been transformational for IMAP, with the divestiture of operations in China announced on April 2nd. 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, built a new U.S.-based leadership team and completed the key governance and corporate development milestones.

Dr. Sean Foo: 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 that a combination of our differentiated pipeline, experienced a leadership team, and strong cash balance position will let us to make meaningful progress in the second half of 2024 and beyond.

Dr. Sean Foo: 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.

Operator: Well now we are conducting a question and answer session. If you like to ask a question at this time, you may press star one from your telephone keypad and a confirmation tone to indicate your lines in the question queue. You may press star two if you would like to withdraw your question from the queue. For participants that are using speaker equipment, it may be necessary to pick up your hands up before pressing the star key. Please. One more please. We'll be poll for questions. And once again, that's star one. Thank you.

Joe Katanzaro: First question will be coming from the line of Joe Katanzaro with Piper Sandler. Please excuse your questions.

Dr. Philip Dennis: Thank you everybody. Thanks for taking my questions. Maybe I had a couple on give a stomeg. First one on the upcoming Esmo update. Winnerman, 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 monitor be profile there. And then second question, appreciate the comparison to Zilba Tuxabab. But wondering if you had any thoughts on how give them maybe compares to the growing quad in 18.2 ADC landscape and where it could differentiate versus those programs.

Dr. Philip Dennis: Thanks. Thank you for your question, Joe. We'll turn that question over to our chief medical officer, Dr. Phil Dennis. Thanks, Tyler. 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 explicit safety and again a notable ORR. But importantly, I think you raised an important question. The way we envision Jeva's development is given its tolerability is to combine it with frontline therapy with Nevolumab and regimen such as Volfox.

Dr. Philip Dennis: And I think that's 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 compared Jeva against the ADC that is being developed by AstraZeneca, our ORR is inferior. But arguably, our talks profile is much better suited for combination and frontline studies. And I think that's the differentiating feature. I think for an ADC targeting 18.2, the movement of 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 Volfox, for example. So I think that's a differentiating feature where we can be more readily combined with frontline therapy.

Joe Katanzaro: Okay, great. That's all helpful.

Joe Katanzaro: Thanks for taking my questions.

Kelly C: Our next questions come from the line of Kelly C with Jeffries. This is your three questions.

Kelly C: Hi, this is Hansel Sue for Kelly Sue congrats on the progress in first half of 24. I just have two quick questions. First, what is your target finish day for the transitioning to the US based auditors? What should we think about expenses going forward split between US and China? The second question is for the pipeline strategy as you're thinking about the expansion to your pipe adding more assets to your pipeline. Are you still focusing on oncology space or looking to expand to other therapeutic areas?

Kelly C: Thank you for your question, Kelly. Was it possible to repeat the first question and we'll turn the question over to Sean, our interim CO to answer? Sure. The first question is what's your target finish day regarding the fully transitioning to a U.S.-based auditor? Yeah, thanks for that question. We have completed the transition. The PWC-US is now our corporate auditor and we've been working closely with them since the completion of the transition.

Kelly C: So this is an important accomplishment. And together with other corporate developments after the digestiture, 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 them earlier, the going burn rate will be considerably lower compared to what you saw in the first and second quarter of this year because we have streamlined organization with focus on clinical development programs going forward.

Kelly C: And the other question you asked about the pipeline strategy, yes, we are actively looking to further enhance our pipelines 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 to modalities. We are also open for discussion and a collaboration, but oncology is one area we obviously see synergy.

Kelly C: And I think that the final part of the question has to do with going forward with the pipeline strategy. We are squarely focused on execution of our internal pipeline to see that we explained in detail today by Phillips. And we are excited about these pipelines, so we are looking to licensing and we are 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 IMAP in the next year.

Dr. Sean Foo: Great. Thank you. As a reminder, if you would like to ask a question, you may press star one from your screen. Please excuse your question. Hi. Thank you. Congratulations on the progress. Thank you for taking my question. Just two quick ones from me. For you, on the MAP combination study, could you talk a little bit about what you need to see on the advocacy front for this new study? And what are some of the external signals you are using to benchmark your goals, let's no-go decisions?

Dr. Sean Foo: And then as an example, I would like to ask you a question. Thank you very much for taking my question. Thank you for a question, Andre. I will direct your question to our chief medical officer, Dr. Phil Davis. Thanks. And I-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-in our phase two, the sense is that the comparison is keynote 189 where we know the medium-PFS is about nine months, and we know the ORR can vary depending on the PDO1 expression.

Dr. Sean Foo: 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 two will 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-from competitor studies because positive outcomes from these competitor studies will really validate the identity pathway.

Dr. Sean Foo: And these studies include studies with ELECTLAMAT that is being developed by AstraZeneca in earlier stages of disease, resectable disease, stage three on resectable disease, excuse me, as well as antibodies against CD39 and small molecules. So we think that this will help, again, propel the field forward, give us confidence in you in the pathway. And I think with the signal that we hope to see from our study, from our proposed study with Embro Quimo, and with the TJ Bio-Dublet study that is in the CD73 selective population, we will get support for our hypothesis that it's the patients that have five CD73 expression that benefit most from ELECTLAMAT. Great, thank you very much. Thank you.

Dr. Sean Foo: At this time, we have no additional questions, and I'll hand the call back to Dr. Sean Foufe for closing remarks. Great, thank you very much, again, for taking the time to join our call today. And so you can gather from the discussions and the presentations were very excited about the pipeline, and the team is dedicated to continue to push the pipeline forward in the most efficient and the scientific way. And we look forward to updating you on our future progress. And if you have any follow-up questions to reach out to Tyler Hello, our head of investor relationships. Have a great day. You may not disconnect the call. This will conclude today's conference.

Operator: Thank you for your participation.