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| Statement |
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| We embark on this change by building on the company's strong foundation from a core set of differentiated oncology assets, a strong balance sheet and a skilled R&D organization in China now |
| So I think combined with these two features, I think even in the first-line setting, even with the pending zolbetuximab approval, we still think we can actually position our drug very broadly in the first-line gastric esophageal space just because of the broader [indiscernible] with Claudine expression as well as the favorable safety profile |
| So our data so far really highlight the favorable safety profile of givastomig |
| So we're quite encouraged by what we've seen to date with givastomig and the ability that givastomig could help address the unmet needs for a wide range of patients |
| So we see very encouraging results of this antibody in first-line non-small cell lung cancer |
| We believe that both uliledlimab and givastomig each have interesting biology, encouraging early clinical data and differentiated characteristics that have enabled them to stand out from other drugs in development |
| But that doesn't mean that we are keen on partnering until it makes strategic sense, and we believe that, that option produces the highest value for our shareholders in the near to midterm |
| I think as I look within the company and talk with my colleagues in R&D and in business development, we're very excited about our assets |
| And we're excited about the growing large commercial opportunity that we have available for the human growth hormone product |
| But again, I think if I had to put pen to paper and think about a timeline that should be important, it should be by the end of 2025, second half of 2025, we should be in a good position to look back and say, how is our strategy working and how is it enhancing the value for our shareholders |
| Lastly, we're pleased to report hot off the press positive Phase 3 data from eftansomatropin alfa, our long-acting human growth hormone candidate being developed for the market in China |
| And as we review the results coming in from this trial, we're quite pleased by the safety profile that we've observed in this trial as compared to Norditropin |
| And given the strong results that we just disseminated, I believe this will be a valuable option in the China market, especially in a growing multibillion-dollar growth hormone market |
| I-Mab's strong cash balance is estimated to provide the company with adequate funding to support the execution of the company's strategic plan |
| These data create a strong clinical database supporting the potential clinical utility of I-Mab's long-acting human growth hormone candidate |
| And I think we have a very healthy balance sheet to be able to take them forward on our own at this time |
| So we're optimistic -- the program is early still, but we're optimistic that givastomig may be able to bring benefit to a broader and much broader group of patients with lower Claudin 18.2 expression as well |
| We are quite excited about the potential of eftansomatropin alfa as a weekly option for our patients |
| Two, maintain our strong balance sheet |
| Also, I'm grateful for the dedication and hard work shown by the entire I-Mab team |
| We continue to believe that our molecule is differentiated |
| As you can tell, we're very excited about this particular program, including our TJ-L14B that we're collaborating with ABL Bio |
| I came to this new role with much confidence in I-Mab’s innovative programs and an understanding that we have a great deal of work ahead of us |
| To conclude, I'm even more convinced than before that I made the right choice to join I-Mab and that we're on the right track with the strategic plan |
| I would like to reiterate our strong cash position of $414.6 million as of June 30, 2023, which allow us to execute our strategic plan |
| We continue to believe that our molecule is differentiated |
| In addition, I think we're pleased with how the safety profile of this drug looks compared to other drugs in the field and we look forward to disclosing those more completely in the future as we disclose the full data set |
| And we believe that uliledlimab has the potential to improve upon currently available care |
| with long-acting growth hormones estimated to significantly build market share |
| I think all of the results that we've generated in the program to date give us the confidence, especially in advancing that program in the settings that John articulated in his prepared remarks |
| Statement |
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| In particular, the GI side effects is actually quite challenging for the clinicians to manage |
| And we know that the [Gilead and Bayer Oncology] (ph) just terminated their project due to limited efficacy |
| Certainly, they have a challenging task and regulatory guidance changes from time to time |
| Unfortunately, earlier attempts to develop 4-1BB drugs caused severe toxicities because the widespread effects of 4-1BB stimulation cannot be tolerated by patients |
| Some of these risks are beyond the company's control and could cause actual results to differ materially from those mentioned in today's press release and on this earnings call |
| As previously reported, uliledlimab is differentiated by design to avoid hook effect biology, which is a potential liability of other competitor drugs in development |
| I guess I had two questions |
| In addition, we will continue monetizing non-global core assets and make the difficult choices where needed in our pipeline to earmark cash for the most promising programs, including exploring external opportunities |
| As we said before, I think it's a little premature for us to think about a decision whether we should continue or stop the molecule development |
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