I-Mab's (IMAB) Q2 2020 Results - Earnings Call
I-Mab (NASDAQ:IMAB) Q2 2020 Results Earnings Conference Call August 31, 2020 8:00 AM ET
Company Participants
Jingwu Zhang Zang - Founder, Honorary Chairman
Joan Huaqiong Shen - CEO
Jielun Zhu - CFO
Ivan Yifei Zhu - Chief Commercial Officer
Conference Call Participants
Xipeng Feng - CICC
Louise Chen - Cantor Fitzgerald
Zhongping Yuan - Huatai Securities
Jill Wu - CMBI
Operator
Good day, ladies and gentlemen. Thank you for standing by, and welcome to the I-Mab 2020 Interim Financial Results and Business Update Conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.
It is now my pleasure to turn the call over to Jielun Zhu, I-Mab's Chief Financial Officer and Director. Please go ahead Mr. Zhu.
Jielun Zhu
Thank you, Rachel. Welcome to the I-Mab 2020 Interim Financial Results and Business Update Conference Call. Earlier this evening, we issued a press release providing a review of our financial results for the six months ended June 30, 2020 as well as an overview of our recent corporate highlights and upcoming milestones. The press release can be accessed on the Investors portion of our corporate website, ir.i-mabbiopharma.com.
Joining me today on the call from I-Mab's senior management team are Dr. Jingwu Zang, our Founder, Honorary Chairman and Director; Dr. Joan Shen, our Chief Executive Officer and Director; and Mr. Yifei Zhu our Chief Commercial Officer. Mr. Zhu recently joined I-Mab and will be driving our commercialization efforts in preparation of our first product launch in China.
Dr. Zang will provide a high-level overview of our recent achievements and upcoming milestones; and Dr. Shen will comment on the status of our key development programs in greater detail. I will then provide a brief summary of our financial results for the six months ended June 30, 2020 before we turn the call back over to the operator, so we may take your questions.
Please note the discussion today will contain forward-looking statements relating to the company's future performance and are intended to qualify for the Safe Harbor from liability as established by the U.S. Private Securities Litigation Reform Act. Such statements are not guarantees of future performance and are subject to certain risks and uncertainties, assumptions and other factors.
Some of these risks are beyond the company's control and could cause actual results to differ materially from those mentioned in today's press release and this discussion. A general discussion of the risk factors that could affect I-Mab's business and the financial results is included in certain filings of the company with the Securities and Exchange Commission. The company does not undertake any obligation to update this forward-looking information, except as required by law.
During today's call, we will also discuss certain non-GAAP financial measures for comparison purposes only. For a definition of non-GAAP financial measures and a reconciliation of GAAP to non-GAAP financial measures, please see the financial results news release issued earlier today.
Now I will turn the call over to Dr. Jingwu Zang, our Founder, Honorary Chairman and Director. Dr. Zang, please go ahead.
Jingwu Zhang Zang
Thank you, Jielun. Thank you all for joining us today. I am very pleased to welcome all of you to our 2020 interim financial results and business update conference call. This is an exciting time for I-Mab. We have made substantial progress in pipeline development as well as corporate development over the last several months and we are on our way to becoming a leading fully integrated global biopharma company.
Firstly on the pipeline development side, we've continued to make remarkable progress across all programs in our pipeline. Lemzoparlimab or TJC4 is an exciting drug molecule discovered and developed internally and is highly differentiated from some other clinical stage anti-CD47 molecules in development. We have recently completed the Phase 1 dose escalation clinical trial in the U.S. and the results have largely validated the key differentiations of lemzoparlimab in safety and favorable PK profile in cancer patients. Joan will provide more details on the clinical data as well as our clinical development plan for lemzoparlimab in a few minutes.
TJD5, our differentiated anti-CD73 antibody, continues to advance in a Phase 1 dose escalating clinical trial in patients with advanced solid tumors in the U.S. and parallel clinical trials of TJD5 in combination with PD-1 antibody is on track in China. We look forward to safety and a PK/PD result from our advanced [ph] trial that are expected to be available in the fourth quarter of 2020.
Like CD47, we believe CD73 represents another promising immuno-oncology target that may make a significant difference in the treatment of cancer. TJM2, our anti-GM-CSF antibody, is currently being evaluated for its role in the treatment of cytokine release syndrome associated with severe COVID-19. This development program exemplifies not only our commitments through innovation to deliver new therapeutic approaches to address unmet medical needs and also our ability to leverage our strength in regulatory and the clinical development capabilities to quickly react to a global health crisis such as COVID-19.
We are now on track to advance a ongoing randomized, placebo controlled, pivotal clinical study to evaluate the efficacy and safety and the cytokine levels in 120 patients with severe COVID-19 in the U.S. Now in addition, we have recently initiated a Phase 1b study with TJM2 in patients with rheumatoid arthritis.
TJ202, our CD38 antibody in our China portfolio is being evaluated in two parallel registrational studies in China for the treatment of multiple myeloma. The trials are on track for patient recruitment in 2020. We expect to file a BLA for TJ202 around mid 2021 or in the third quarter in 2021. We also look forward to progressing the ongoing Phase 2 clinical trial for TJ301 our differentiated interleukin-6 inhibitor towards completion in patients with ulcerative colitis.
Towards this we expect to obtain an IND approval for our registrational trial for TJ101 our long-acting growth hormone for pediatric growth hormone deficiency. Similarly, we plan to initiate a Phase 2 clinical trial for TJ107, our long-acting interleukin-7 for glioblastoma patients with lymphopenia. We are very excited about getting these two clinical assets started in Phase 2 and Phase 3 clinical trials respectively.
Secondly, on the corporate development side, while rapidly advancing our pipeline developments with great execution efficiency we have begun to build out commercialization capabilities. In this regard I want to highlight the recent appointments of Mr. Ivan Yifei Zhu as our Chief Commercial Officer. Mr. Zhu has more than 20 years of successful commercialization experience and held senior executive positions at global domestic pharmas and biotech companies. He will focus on building and developing I-Mab's commercialization infrastructure, strategy and preparing the company for future product launches. Mr. Zhu is a great addition to our management team.
As part of I-Mab's plan to expand our global footprint in May we had announced the opening of I-Mab's Hong Kong office serving as regional hub for the company's capital markets and investor relations activities. In addition, we plan on building an R&D center in San Diego starting late 2020 to focus on translational medicine, biomarker analysis, and innovative formulation research, which will support the rapid progression of innovative pipeline globally.
As I mentioned at the outset, I-Mab is well positioned to become a leading fully integrated global biopharma company focusing on immuno-oncology. With more and more clinical milestones achieved the innovative potential of our pipeline has become more visible and validated as an exemplified lemzoparlimab or TJC4. Looking ahead, we are very excited and confident in our science and the increasing abilities to deliver value innovation to patients as well as for our shareholders.
Thank you now for your attention. I will now turn the call over to Dr. Joan Shen, our CEO who will review the status of our key development programs in great details. Dr. Shen?
Joan Huaqiong Shen
Thank you, Dr. Zang. Now I will be focusing my discussion on our plans to proof-of-concept portfolio first. So today, my focus is the three monoclonal [ph] lemzoparlimab, TJC4; uliledlimab or TJD5 and plonmarlimab or TJM2. So these programs are currently simultaneously developing in both U.S. and China.
So the first one is our TJC4 or lemzoparlimab, which as Dr. Zang mentioned earlier, is our highly differentiated CD47 antibody. It is designed to inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating it from other antibodies of the same class currently in development. There are two, Phase 1 and Phase 2 studies ongoing in both U.S. and China.
In the U.S. as Dr. Zang mentioned, we have recently completed the first part of the study which is dose escalation study demonstrating the tolerability, safety, and the PK profile without any prior [ph] dosing strategies. The study has conducted a dose range of 1 to 30 mg/kg. In all DLT-evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. The full clinical data will be released separately and presented at an appropriate scientific conference later this year, so please stay tuned.
So the same studies have been now proceeded as planned into a combination treatment with pembrolizumab in patients with severe type of solid tumors through a collaboration with Merck and is also proceeded with combination treatment with Rituximab in patients with Non-Hodgkin's lymphoma. Lemzoparlimab we are also developing it in Phase 1/2 trials in patients with hematologic malignancies such as relapsed or refractory AML and MDS. Despite the COVID-19 interference, the trial is ongoing smoothly and the data for the trial are expected to be available in early 2021.
So now the second compound I'm going to share with you is our TJD5 or uliledlimab. It is differentiated CD73 antibody. As Dr. Zang mentioned it represents another promising immuno-oncology target under clinical development globally. We believe the key when compared with some of the other clinical stage antibody of the same kind is related to its novel epitope, which works through a unique intra-dimer binding mode, resulting in a complete inhibition of the enzymatic activity and avoiding the aberrant pharmacologic property known as the hook effect.
It is currently being evaluated in the U.S. in a Phase 1 dose escalating study in combination with atezolizumab which is under collaboration with Roche. We are testing the safety, probability, and preliminary efficacy. The preliminary data are expected in fourth quarter of 2020. So in the same time uliledlimab is being evaluated in another Phase 1 study in China for its safety, tolerability, PK/PD and potential efficacy, primarily in patients with solid tumors, including lung cancers as a single agent and the combination therapy with PD-1 inhibitor in collaboration with Junshi Pharmaceuticals [ph].
So now, the third compound, TJM2 or plonmarlimab. This is a neutralizing antibody targeting the GM-CSF important cytokine that plays a very critical role in acute and chronic inflammation. As we reported earlier, since March we are developing it to treat severe patients with CRS associated with COVID-19. This study has been divided into two parts. First part is more patients were double blind, randomized, placebo controlled, three-arm study to assess mostly the safety profile. We were able to complete this study in early May. It has been demonstrated assessed by a safety committee which gave us green light for proceeding to the second part.
So the second part is focusing on assessing the efficacy, safety and tolerability. As Dr. Zang mentioned, it is a much larger scale of study which currently is ongoing smoothly in the United States. We are also in discussion with FDA closely to prioritize [ph] our clinical protocol making it a potential [indiscernible] of health in the United States.
As Dr. Zang mentioned again, we recently initiated a multi-dose Phase 1b study with plonmarlimab in patients with rheumatoid arthritis in China. We are also proceeding this for additional indications in the autoimmune disease areas as well as some of the relative disease. In the same time we were also looking at the prevention and the treatment of CRS associated with COVID [ph] treatment.
So beyond these three product candidates, our early stage pipeline of novel monoclonal antibody is rapidly advancing towards clinical development in both U.S. and China. We expect a series of IND submissions to the United States FDA, including for TJ210. This is a novel monoclonal antibody directed at C5aR for cancers through a partnership with MorphoSys. We also plan to initiate development of TJ210 in China.
Another exciting early stage program is our TJ-CD4B a dual targeting property combining Claudin-18.2 and then 4-1BB. That is uniquely structured to supercharge the T cells in a Claudin-18.2 dependent manner, enhancing anti-tumor immunity while potentially minimizing toxicity. So in June 2020 I-Mab and ABL Bio, our partner presented the preclinical data on these highly novel assets at AACR Virtual Annual Meeting. We expect to file U.S. IND earlier next year.
Now, I will move on to our Fast-to-Market China portfolio. TJ202 or felzartamab is a differentiated anti-CD38 antibody, originally developed by our partner MorphoSys. We own an exclusive license to develop and commercialize in Greater China. It is currently in development for indication of multiple myeloma and autoimmune diseases such as SLE. We believe felzartamab is potentially highly differentiated compared with the currently marketed CD38 antibody.
First, in a similar premedication condition such as with dexamethasone, TJ202 has demonstrated a significantly shorter infusion time and a lower infusion reaction rate. Secondly, unlike the current marketed CD38 antibody, it does not show to down regulate CD38 expression on the surface of bone marrow myeloma cells in vitro, potentially maintaining the sensitivity of myeloma cells for repeated treatment.
As Dr. Zang mentioned, we are conducting two parallel registrational trials as a third line monotherapy treatment and the second line combination treatment with lenalidomide, both in patients with multiple myeloma in Taiwan and the Mainland simultaneously. These two trials are ongoing and the recruitment progression remains on track. The company we expect to complete a BLA submission in 2021. As we targeted this will be our company's first BLA submission.
Now, another Phase 3 compounds TJ101 or eftansomatropin, which is originally developed by Genexine. This is a very highly differentiated long-acting growth hormone that is being developed as a weekly injectable treatment for pediatric growth hormone deficiency. As compared to currently available daily regimen we believe it has the potential to address important clinical needs and to cover a significant market gap. And the application for registrational trials has been accepted in June of this year and we expect to obtain the IND approval in the fourth quarter of 2020.
For TJ107 or efineptakin alfa we expect to initiate a Phase 2 clinical trial in lymphopenic patients with newly diagnosed GBM in the fourth quarter of 2020.
Lastly, for our TJ301 or olamkicept our IL-6 inhibitor, we are conducting a Phase 2 clinical trial in ulcerative colitis. We expect to complete the recruitment in September actually for 90 patients, and then topline results are expected to be released by early 2021. So after clinical efficacy and differentiations are validated, we plan to develop it in other inflammatory indications in which IL-6 plays a role.
With that update, I will now turn the call back to Jielun, who will discuss our financial results. Jielun?
Jielun Zhu
Thank you, Joan. Now let me turn to review our financial results for the six months ended June 30, 2020. As of June 30, 2020, cash and cash equivalents, restricted cash and short-term investments totaled RMB 1.6 billion or US$221.1 million compared with RMB 1.2 billion as of December 31, 2019.
Now let me turn to the revenue. For the six months ended June 30, 2020, net revenues were nil compared with RMB 15 million for the six months ended June 30, 2019. Now R&D expenses. R&D expenses for the six months ended June 30, 2020 were RMB 442.3 million or US$62.6 million compared to RMB 265.1 million for the same period in 2019. The increase in R&D expenses was primarily due to increases in our CRO service fees to advance the company's pipelines. Higher share based compensation and higher employee salary and benefits expenses due to increased research and development headcount.
Now the administrative expenses, administrative expenses for the six months ended June 30, 2020 were RMB 171.4 million RMB or US$24.3 million compared to RMB 574.6 million for the same period in 2019. The decrease was primarily due to reduced share based compensation expenses of RMB 268.9 million or US$38.1 million.
For the six months ended June 30, 2020, I-Mab reported a net loss of RMB 582.9 million or US$82.5 million compared to a net loss of RMB 857.3 million for the same period in 2019. Non-GAAP net loss, which excludes the share based compensation expenses, was RMB 353.1 million or approximately $50 million compared with non-GAAP net loss of RMB 491 million for the same period in 2019.
With that, we would like now to turn the call back over to the operator, so we can go ahead and take your questions. Rachel?
Question-and-Answer Session
Operator
Certainly. [Operator Instructions] Your first question comes from the line of Xipeng Feng of CICC. Please ask your question.
Xipeng Feng
Okay. This is Xipeng Feng and congratulations on the excellent pipeline results and thank you for taking my questions.
Joan Huaqiong Shen
Hey Xipeng, we can't hear you, can you get closer to the phone?
Xipeng Feng
Okay, how about this? Can you hear me now?
Jielun Zhu
It's better.
Xipeng Feng
Okay, okay. This is Xipeng Feng from CICC and congratulations on the excellent pipeline results. And thank you for taking my questions. I have two questions actually and firstly, it's about CD47 antibody or lemzoparlimab. Well, I noticed that no DLT or severe hematologic adverse events were observed in all DLT available patients and now, I think the market may keep an eye on the future R&D plan regarding the potential indications, and even specific product tests.
And currently, we see combo therapies for CD47 antibody. And we also noticed that the company has already achieved the layout in the CD47 related bi-specific products is well, including CD47 and PD-L1, CD47 and GM-CSF. So I just wondered, could you please share some more colors on future R&D plans on these bi-specific? Thank you.
Jingwu Zhang Zang
All right. This is a Jingwu. Maybe I can take your question. So you have two questions. Maybe I'll start to first address your question related to bi-specific antibodies. In our pipeline, we do have two CD47 related bi-specific programs, both of them at this point at CMC preclinical stage. One is the CD47 GM-CSF, which is designed as a 45 CD47 antibody to more effectively treat solid tumor as GM-CSF works synergistically to enhance tumor killing M1 macrophage.
Okay, so we're quite excited about this molecule because it's specifically designed to enhance intended clinical efficacy for solid tumors through activation of M1 macrophage. The other bi-specific program is CD47 PD-L1. We're also quite excited about this program because it is designed to combine two powerful immune pathways, PD-L1 and CD47 to work together to achieve a better treatment efficacy.
So we are at this point of advancing both programs in the CMC and preclinical stage and we expect to file IND sometime next year in the U.S. to get clinical trials started. We're very excited about these two programs because we believe that they have intrinsic quality to become potentially a second generation CD47 treatment. So this is the first question.
Now the second question is related to our program, CD47 program. As we just mentioned on this call, we just completed the dose escalation study just a few weeks ago. Now we are in the process of analyzing and digesting all of the clinical data, PK/PD data we recently generated from both our U.S. trial and China Study.
Now we are currently, we are finalizing our clinical development plan. So today, I don't have all the details for our clinical development plan to share with you, but I can tell you that our strategy for clinical development of TJC4 is twofold. First, we will focus on AML and MDS as the first indications for product registration both in U.S. and in China. Okay and our ongoing trial in China will expand to a pivotal study aiming for registration and we will start a parallel clinical trial in patients with AML/MDS in U.S. sometime soon, next year. So, the first purpose is really for registration for AML/MDS.
Now, secondly, we are also working on solid tumors, and currently in the U.S. trial we will expand to a combination study with PD-1 antibody for solid tumor and also with RITUXAN for non-Hodgkin's Lymphoma and we will soon get some get a trial advanced to a certain point where we can collect sufficient data to make a judgment in terms of safety and some early efficacy signal. Now, the solid tumor studies will be carried out both in U.S. and China very soon.
Xipeng Feng
Okay, thank you so much Dr. Zang. And actually the CD47 antibody is my first question, and my second question is about the TJM2 or plonmarlimab. And I just wonder, would it be possible that this Phase 2 study for Cytokine Release Syndrome can be or may be regarded as registrational trial, what's the potential attitude from FDA?
Jingwu Zhang Zang
Yes, I would direct your question to Joan to address.
Joan Huaqiong Shen
Yes, I think you got the right point. So we have successfully like advanced it from Phase 1 to Phase 2 by having like smaller trials, we've been focusing in safety early in May. Now we are full Phase 2. So, exactly like you had -- you wondered we started the communication with FDA and then we are in the final stage of completing or in making agreement of our endpoint and the population. So, most likely, we will be able to advance to the potential registrational trial from here now.
Xipeng Feng
Okay thanks. I have no questions and congratulations again for your excellent half year results. Thanks.
Joan Huaqiong Shen
Thank you.
Operator
Your next question comes from the line of Louise Chen of Cantor. Please ask your question.
Louise Chen
Hi, thanks for taking my questions and congratulations on the TJC4 data today. So I have three questions for you. First one is how have healthcare reforms created an opportunity for China based biotechs to become innovative organizations?
The second question is, do you believe the domestic Chinese market could become a leading market globally? And if so, when would that be three years, five years, seven years from now? And the last question is, where would TJD5 fit into the treatment paradigm if it is approved and why? Thank you.
Jingwu Zhang Zang
Thank you for the question. For the first two questions I would like to direct them to Jielun, our CFO. Jielun, could you elaborate the first two questions?
Jielun Zhu
Sure, Dr. Zang. I remember you’re two questions. So the first one is about how healthcare reforms presented an opportunity for China based biotechs to become more innovative. I think we shared this view with a lot of our peers that, that this is the golden age for, I think for China based biotech companies to grow and become globally competitive. There is a confluence of a number of driving forces that have sort of converged to make this happen.
The first one is obviously the regulatory, on the regulatory side. With China entering the Global ICH system, with more reforms in the drug approval process, making it possible for scientific and clinical data to be exchanged more freely across borders and introducing more flexibility in the drug approval process.
This is something that we haven't really seen five or 10 years ago. But we're now seeing a lot of the flexibility being injected into the drug approval process. The second factor I think is related to funding or financing. We have seen just an exploding growth from some biotech VC and PEs both outside of China and also in China, funding a lot of the promising biotech ventures from funding phase also through to the IPO.
And the other important point here is also that we have seen the opening up of lot of the regional capital markets. For example, the Chapter 18A market in Hong Kong, and also the stock market in Shanghai. And they allow - these markets now allow pre-profit and pre-revenue companies to go public and raise funding. This is something that we haven't, we didn't see, five or 10 years ago again.
And I think the next point is, is about talent. We're just seeing increasing amount of or number of returnee scientists and clinicians going back to China, and they cover a number of aspects or all of the key aspects of the biotech value chain from early stage discovery to CMC, to clinical and regulatory. And they play a very important role in terms of forming the next exciting biotech ventures in China.
And I think the last one is about reimbursement. It used to be that a lot of the insurance dollars in China were paying for generic drugs or me too drugs. We're seeing efforts from the insurance administrators to recycle the insurance dollars and prioritizing payments to cover really innovative drugs. And I think this is one of the driving forces to support the next leg of growth for innovative drug companies.
I think the next question you asked is about, whether we believe the Chinese market will be, a leading or one of the leading markets globally. And if so, would that happen in three or five or seven years. We are actually very optimistic in the growth aspect of the Chinese market. I think you can look at a lot of the statistics. Chinese pharmaceutical market is now the second largest in terms of single nation state pharmaceutical sales.
And if you look at a lot of the reputable market research firms, including Frost & Sullivan and maybe McKinsey and others, the consensus is the Chinese market will keep growing at a fairly respectable 5% to 10% annual growth rate over the next five to 10 years. Again, a lot of the driving forces for this growth sustaining this growth is what I talked about earlier. The demand for better care, standard of care, the insurance program being more focused on the innovative therapies, emergence of a new generation of biotech companies like us and even perhaps a more diversified payer structure, with more commercial insurance coming into the picture to pay for these innovative drugs.
We think going forward, and it's very likely that, in the next five to 10 years, China will catch up in terms of the pharmaceutical market, catch up to the U.S. and end up becoming a leading market for innovative therapies, not only for multinational companies but also for local biotech companies and pharmaceutical companies in China. Thank you very much.
Jingwu Zhang Zang
Now I can address your third question regarding TJD5, CD73 monoclonal antibody. CD73 is a very promising immuno-oncology target, is globally competitive. Currently there about five companies at clinical stage including TJC5 our CD73 TJD5, our CD73 monoclonal antibody. Now TJD5 is a differentiated CD73 antibody as Jielun already mentioned. It works through a intra-dimerization mechanism to avoid the hope [ph] effect.
It has defined a clinical advantage over some of the other CD73 antibodies. Now TJD5 or CD73 antibody works synergistically with PD-1, PD-L1 therapies as it creates a favorable tumor microenvironment for PD-1, PD-L1 to work more effectively. So, you can imagine that this monoclonal antibody is positioned clinically to combine with PD-1, PD-L1 therapies to potentially increase patient's clinical response rate and hopefully efficacy of the PD-1, PD-L1 therapies. And this is how; this is the consensus in the fields how CD73 would have worked synergistically with PD-1, PD-L1 therapies.
Now, we are conducting clinical trials in both U.S. and China. The U.S. study, as mentioned earlier is in combination with a PD-L1 antibody in solid tumor and the China Study is in combination with a PD-1 antibody in solid tumor and our Phase 1 data to dose escalation, safety PK/PD from our U.S. study will become available at the end of 2020. I hope that we addressed your questions.
Louise Chen
Yes, thank you very much.
Jingwu Zhang Zang
Thank you.
Operator
Your next question comes from the line of Zhongping Yuan of Huatai Securities. Please ask your question.
Zhongping Yuan
Hi, thank you for taking my questions. Congratulations on your clinical breakthroughs in TJC4 and I have two questions here. And the first question involves the competition in the CD47 market. And I noticed that Innovent has just initiated a Phase 1b and a Phase 3 clinical study of its CD47 antibody IBI-188 for the treatment of MDS and as just explained by our interim reports, our company will conduct a Phase 2a trial in China.
So I'm very curious that in the process that IBI-188 will lead the competition of CD47 antibody in China's market. Also, I'm also interested in one of our peers on the TTI-621 of Trillium. This drug has demonstrated some certain actual [ph] possibilities in its clinical study, and this possibility is rarely observed for other kinds of things. So what is the cause of toxicity and what did our company do to avoid it? Yes, this is my first question. Thank you.
Jingwu Zhang Zang
All right, thank you for the question I can address your questions. First of all, I'd like to say our CD47 antibody is globally competitive and I will address this in two ways. One is quality, the other quality or differentiation, the other is the speed. In terms of differentiation, our TJC4 stands out as highly differentiated CD47 antibody, because it binds minimally to red blood cells, our design has shown its clinical advantages as it does not induce severe anemia, and other hematologic side effects in those preclinical studies and now, clinical studies. We are very excited about this differentiation.
So that's one aspect related to the quality of the molecule and the differentiation of the molecule. Now, the other aspect is speed. With the clinical advantages of our TJC4 we are rapidly advancing our clinical development plan in both U.S. and China. As you can imagine, our antibody is well tolerated in the clinical studies. It behaves as one of the regular antibodies with safety and also a more favorable PK profile. So we know our problems, our problem is it's very competitive at this point, but we're not in a position to comment on other company's programs. But we know that we're already advancing very fast both in U.S. and China and we have a very clear clinical development plan, how to move forward now with that demonstrated clinical advantages or differentiation.
And then your second question related to Trillium's molecule, now, Trillium's molecule TTI-621 is associated with dose limiting thrombocytopenia. Now it's quite clear thrombocytopenia induced by this molecule TTI-621 is mediated through ITT function of the molecule. Because CD47 is also expressed on the platelets with an effect of function of ITT1, you'd expect to have thrombocytopenia because of the elimination of the platelets. And this is the, this is really the underlying mechanism for thrombocytopenia induced by TTI-621.
Zhongping Yuan
Okay, thank you for your answer. And I have got one more question about our plan for commercialization. And we noticed that Mr. Yifei Zhu has joined the company and he will in charge of our commercialization plan. And could you tell us, what's the current and the target headcounts of our sales team? And what will be the major candidates in the near future, for example in the late 2020? Thank you.
Jingwu Zhang Zang
Thank you for your question. I will direct your question to Mr. Zhu, our newly joined Chief Commercial Officer.
Ivan Yifei Zhu
Okay. Thank you for your questions. And first of all, I just got on board with I-Mab and I'm very excited about the company's [indiscernible] plan and it's a huge commercial potential as the only product clearly differentiated. So as our initial product series are related to the hematological malignancies, and such as TJ202, and the TJC4, and we initially and the focus on building our commercial operability in hematology market. So with regard to the TJ202, it will be the first of our drugs to market in China.
So we are very excited about this product launch, and strategically preparing for it with the formation of our own commercial team. The general plan is to form our own core immuno-oncology sales team of 150 to 200 people, so focusing on the most important 280, tertiary, and also the specialized the oncology hospitals in China. So we made those days in Phases to match and the TJ and TJ202 and commercialization process. So we will start the other team having office soon. Thank you.
Zhongping Yuan
Okay, thank you.
Operator
Your next question comes from the line of Jill Wu of CMBI. Please ask your question.
Jill Wu
Thank you for taking my questions and I have two questions. One question is in relation to TJC4. We understand that the company may have been in discussion with potential partners for preparation of this product. Could you please give us some updates on that front? And my second question is about TJ-CD40, this is a bright innovative bi-specific antibody, could you please give some color on the potential indication of this molecule? Thank you.
Jingwu Zhang Zang
All right. Thank you for the questions. I can address your question. Now your first question as discussed earlier on this call, our TJC4 spans out as highly differentiated CD47 antibody. It has really attracted a lot of interest from Big Pharma groups around the world. They have been seeking a differentiated CD47 antibody. Now we have been approached by potential partners for collaboration and that discussion is ongoing. And today I can say we will update the market as soon as soon as it is finalized.
Your second question is related to second question, bi-specific Claudin 18.2 and 4-1BB, now this bi-specific antibody has first in class potential, it's very unique. It's a combination of clotting acting point to a new tumor associated antigen related to cancer, pancreatic cancer and this is combined with our 4-1BB antibody and this 4-1BB antibody is conditionally activated 4-1BB.
Let me explain. So, the 4-1BB has to rely on Claudin 18.2 in this case, to engage its target tumor cells in order to -- in order to get activated. So results 18.2 engaging the tumor cells 4-1BB is not activated. So, that design is very smart. It can potentially reduce the systemic exposure of 4-1BB because 4-1BB is known to induce liver toxicity. So this antibody is designed to avoid systemic toxicity, especially the liver toxicity.
So this antibody at this point is at preclinical development. We expect to file IND in the first quarter next year to get clinical trials started in the U.S. And this particular bi-specific antibody is positioned clinically to treat cancers, gastric cancers and pancreatic cancers.
Jill Wu
That's very clear. Thank you.
Joan Huaqiong Shen
Hi, operator just to let you know, we can only take one more speaker, only one more participant's question due to time.
Operator
Your last question comes from the line of Clara Wang of China Renaissance. Please ask your questions.
Unidentified Analyst
Thank you for taking my questions. Congratulations and very good progress in clinical trial. I'm just wondering for the TJM2 indicated for severe COVID-19 patients, wondering if it could be used as a substitute for steroids or other hormones as a treatment? Thank you.
Jingwu Zhang Zang
Thank you for your question. I'd like to direct your question to Joan.
Joan Huaqiong Shen
Yes. Hi, thank you again. I think this is a very good question. Some people have wondered, but there are lot of science which is backing up that, corticosteroids treatment has its biggest concern in terms of export [ph] immune system suppression, which could lead to more severe systemic infection and harm to other important organs. So, if you look at the data, so almost all the cases, especially in severe cases, the lab results showed that all the immune cells, especially T cells have been compromised significantly.
So under these circumstances, corticosteroids could very likely to be compromised even further, putting patients in more dangerous situation for more infections. So GM-CSF is very different. It worked in upper screens [ph] of a cytokine release; it just works as a switch. So the switch off and on of those cytokine release very tough focus to be targeting on the cytokine release, as you know has been in the literature reported, it is very specifically related to cytokine release associated with COVID-19.
So, we believe GM-CSF has the uniqueness for targeting the cytokine release associated with COVID-19 without compromising the general immune systems. So, if that works out, then we definitely be we have much better advantages over steroid treatment. So, hope that has answered your question.
Unidentified Analyst
Very clear. Thank you.
Joan Huaqiong Shen
Thank you
Operator
I would now like to turn this call back to the management for closing remarks. Please go ahead.
Joan Huaqiong Shen
Thank you everyone for participating in the call. Yes, Jielun go ahead.
Jielun Zhu
Yes, we on behalf of the management, we would like to thank everyone who joined this call this morning or tonight depending on where you are. Unfortunately, given the time constraint, we may not be able to take everyone's questions. But rest assured, we will find other opportunities to keep the dialogue open with investors and analysts. Thank you again for your time today. Have a nice day or night. Thank you. Bye-bye.
