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| So again, very good functional data showing that Tegoprubart modulated the immune system in that study |
| And these are patient population, as you just suggested, that -- these patients and transplant and ALS are very sick and yet the drug has shown a very good safety profile at this point and very predictable on pharmacokinetics as well |
| Globally across all of our indications, the safety profile of Tego continues to look very exciting and very encouraging |
| The receptivity has been absolutely amazing |
| Graft function was very good in all three participants with the participants having eGFR as a 54, 85 and 77 at the latest available time point of 49, 154 and 217 days, respectively |
| I am proud of the progress that Eledon has made in the early part of 2023 and feel we are now well positioned to make significant strides in our evaluation of Tegoprubart as a potential much-needed replacement for CNIs in kidney transplantation |
| It's a well-established -- it has a well-established kidney transplant franchise, so well versed in the space |
| And so we think it's a potentially great upside |
| So the second-generation antibody, Tegoprubart, that we now have clinical data for us has really generated an incredible amount of excitement as we've reached out to potential sites for the BESTOW study and doing feasibility |
| And the PIs have been very impressed with the eGFR data that we have to date, albeit on a handful of patients |
| And I'm glad to see we have a bolstered balance sheet and looking forward to more data |
| And it did so in a very rapid way after the first infusion, which was quite exciting |
| We're obviously really excited that the agencies are starting to look at alternative endpoints like iBox, which can be really transformational as far as helping to assess early-stage clinical trial development and the ability to estimate long-term graft function and survival |
| These results were highly encouraging and suggest early clinical proof of concept for Tegoprubart in this indication |
| Finally, following our financing, we now have a well-capitalized path to launch and execute our Phase 2 BESTOW trial while we continue to report data from the open-label Phase 1b study in parallel |
| Given the correlation between eGFR levels at 90 days and 12 months, we feel encouraged by these early results and their potential to translate into longer-term graft functionality |
| In addition to the clinical progress we made this year, we also strengthened our balance sheet through the execution of a private placement financing of up to $185 million, including $35 million upfront |
| We are encouraged by the safety profile Tegoprubart continues to display, and to date, we have now dosed approximately 100 human subjects across multiple disease indications |
| But folks have been very excited because of the opportunity to reengage this pathway after so many years |
| I think they looked at us and saw a good investment opportunity |
| In addition, we observed strong graft function in our participants with mean eGFRs above 70 at measured time points as far out as week 31 |
| The data we presented at WCN from 16 patients in the high dose cohort of 10 mgs per kg every three weeks showed Tegoprubart to be safe and well tolerated with no serious nor severe adverse events reported and no early discontinuations |
| Turning to the safety results we observed in the study, we're among the three participants Tegoprubart showed good tolerability, especially among a difficult-to-treat population |
| Want to congratulate you on your successful financing and are happy to see that the Tego kidney transplant program is moving forward |
| So that opens up an opportunity when you kind of summarize all of that data in total that as we have hypothesized in general going back over 30 years of data, that blocking this pathway really has an opportunity in multiple autoimmune indications as well as in the transplant indications that we're pursuing |
| We believe based on the evidence generated to date that Tegoprubart has the potential to reduce or even potentially eliminate these side effects while also providing improved graft function |
| Our goal is for Tegoprubart to ultimately replace tacrolimus as the standard of care post transplant immunomodulator, significantly reducing the broad number of side effects associated with that drug and thus improving graft function and survival |
| We demonstrated very robust target engagement in our ALS study shown that we knock down both T and B cell markers of target engagement in a very dose proportional way |
| So, removing -- if we're able to allow people to taper completely off steroids, that would be another win on top of removing the CNIs for patients |
| We believe that Tegoprubart, our anti-CD40 ligand antibody, can address a significant unmet need in patients undergoing kidney transplants through its potential to prevent rejection, maintain high graft function, and reduce the many toxicities associated with calcineurin inhibitors or CNIs |
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| But as we know with biologics, you don't want to pause an infusion for too long due to our increased risk of anti-drug antibody responses |
| The adverse events continued once the patient was switched from Tegoprubart to CNIs |
| Kidney transplantation is a growing space which has had limited innovation in decades |
| The company reported a net loss of $10.8 million dollars or $0.75 per share for the three months ended March 31, 2023, compared to a net loss of $9.9 million or $0.69 per share for the same period in 2022 |
| So just wondering if anything there you're seeing so far? And I know that patients -- the number of patients have been low so far |
| Except for perhaps a bit of an exception that we've seen but not performed |
| General and administrative expenses were $3 million for the three months ended March 31, 2023, compared to $3.2 million for the comparable period in 2022, a decrease of $200,000 |
| And finally of course, eGFR is associated with the risk of graft failure |
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