Q2 2022 Eledon Pharmaceuticals Inc Earnings Call

August 11, 2022

[music].

Operator: Greetings, and welcome to the Eledon Pharmaceuticals Q2 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference call is recorded today, 11 August 2022. I now would like to turn the conference over to Paul Little, Chief Financial Officer of Eledon Pharmaceuticals. Please go ahead, sir.

Greetings and welcome to the <unk> Pharmaceuticals second quarter financial results Conference call.

At this time all participants are in a listen only mode.

A question and answer session will follow the formal presentation.

As a reminder, this conference calls we recorded today August 11, 2022, I now would like to teleconference over to Paul Little Chief Financial Officer of valid on please go ahead Sir.

Paul Little: Good afternoon, everyone, and thank you for joining Eledon's Q2 2022 operating and financial results conference call. I am joined on today's call by David-Alexandre Gros, Chief Executive Officer, and Jeff Bornstein, Chief Medical Officer. Steven Perrin, our President and Chief Scientific Officer, will not be joining today's call because he is attending a funeral. Earlier today, Eledon issued a press release announcing financial results for the second quarter ended 30 June 2022. You may access the release under the Investors tab on our company's website at eledon.com. I would like to remind everyone that statements made during this conference call relating to Eledon's expected future performance, future business prospects, or future events or plans may include forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995.

Good afternoon, everyone and thank you for joining <unk> second quarter, 2022, operating and financial results Conference call.

I'm joined on today's call by David Alexander Grill, Chief Executive Officer, and Jeff <unk>, Chief Medical Officer, Steve <unk>, Our President and Chief Scientific Officer will not be joining today's call because he is attending a funeral.

Earlier today <unk> issued a press release announcing financial results for the second quarter ended June 32022, you may access the release under the investors tab on the company's website at <unk> Dot com.

I would like to remind everyone that statements made during this conference call relating to <unk> expected future performance future business prospects or future events or plans may include forward looking statements as defined under the private Securities Litigation Reform Act of 1095.

Paul Little: All such forward-looking statements are intended to be subject to the safe harbor protection provided by the Reform Act. Actual outcomes and results could differ materially from these forecasts due to the impact of many factors beyond the control of Eledon. Eledon expressly disclaims any duty to provide updates to its forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the risk factors set forth in Eledon's reports filed with the U.S. Securities and Exchange Commission. Now, I would like to pass the call to Eledon's CEO, Dr. David-Alexandre Gros. D.A.

All such forward looking statements are intended to be subject to the safe Harbor protection provided by the Reform Act.

Outcomes and results could differ materially from these forecasts due to the impact of many factors beyond the control of the Belo Don.

<unk> expressly disclaims any duty to provide updates to its forward looking statements, whether as a result of new information future events or otherwise.

Participants are directed to the risk factors set forth in <unk> reports filed with the U S Securities and Exchange Commission.

Now I would like to pass the call to <unk> CEO , Dr. David Alexander grow.

Yes.

David-Alexandre Gros: Thank you, Paul, and thank you all for joining the call today. Q2 marked the beginning of an exciting period for Eledon as we reported the first of four distinct clinical readouts from our tegoprubart pipeline with positive phase 2A results in ALS. This year, we have been focused on execution across the four clinical trials: kidney transplantation, ALS, IgA nephropathy or IgAN, and islet cell transplantation. I'm very encouraged by the progress we have made in each of these areas. In renal transplantation, we recently announced the first patient dose in a phase 1B open label study of tegoprubart in Canada, United Kingdom, and Australia. We look forward to the continued enrollment of this study through the remainder of the year.

Sure.

Thank you Paul and thank you all for joining the call today.

The second quarter marked the beginning of an exciting period for Ela, Don as we reported the first of four distinct clinical Readouts from March the Gopro Bard pipeline with.

With positive phase <unk> results in a loss.

This year, we have been focused on execution across our four clinical trials.

Kidney transplantation.

Alice.

Nephropathy or again, an islet cell transplantation.

I am very encouraged by the progress we have made in each of these areas.

And renal transplantation, we recently announced the first patient dose in our phase one open label study is to go provider in Canada, United Kingdom administrator.

We look forward to the continued enrollment of the study.

Through the remainder of the year and based on the timing of our first patient enrolled we aim to provide initial three and six month open label data across available transplant participants in the first quarter of 2023.

David-Alexandre Gros: Based on the timing of our first patient enrolled, we aim to provide initial 3- and 6-month open label data across available transplant participants in Q1 2023. Additionally, we announced the FDA has cleared Eledon's investigational new drug application or IND application for a larger controlled phase 2A trial of tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant, thereby allowing us to expand our development efforts for this important indication into the United States. Jeff will go into the trial design in more detail, but I'll note that this will be a superiority study versus standard of care with calcineurin inhibitors or CNIs. As I mentioned, we were excited to report positive top-line data in a phase 2A study of tegoprubart in adults with ALS in May.

Additionally, we announced that the FDA has cleared <unk> investigational new drug application for IND application.

For a larger controlled phase <unk> trial to go overboard.

With the prevention of Oregon rejection in patients receiving a kidney transplant.

Thereby allowing us to expand our development efforts for this important indication and you do not and states.

Jeff will go into the trial design in more detail.

I'll note that this will be a superiority study versus standard of care with <unk> inhibitors or <unk>.

As I mentioned, we were excited to report positive top line data in the Phase Iia study up to Gopro Barton in adults with AOS in May.

David-Alexandre Gros: Tegoprubart not only successfully met the primary endpoint of safety and tolerability, but showed dose-dependent target engagement and a level of reduction in proinflammatory biomarkers associated with a trend in slowing down of disease progression as measured by ALSFRS slope. Additionally, we observed a reduction in a number of biomarkers also associated with both IgAN and kidney allograft transplant rejection, which we believe provides significant validation of tegoprubart's broad therapeutic potential. With an eye to further progressing ALS clinical development, we will be working with opinion leaders, the patient community, and regulators on potential next steps, as well as looking at different approaches to fund a potential future trial. Next, our phase 2A study of tegoprubart in adults with an IgAN continues to enroll, and we're expanding the enrollment landscape from our current 9 countries with 17 sites into another 3 additional countries, including the United States and China.

<unk> not only successfully met the primary endpoints are safety tolerability, good showed dose dependent target engagement and the level of production and pro inflammatory biomarkers associated with a trend and slowing down of disease progression as measured by ALS FRS slowed.

Additionally, we observed a reduction in a number of Biomarkers also associated with both <unk> and kidney allograft transplant rejection.

Which we believe provide significant validation of the gopro bard's broad therapeutic potential.

David-Alexandre Gros: With an eye to further progressing ALS clinical development, we will be working with opinion leaders, the patient community, and regulators on potential next steps, as well as looking at different approaches to fund a potential future trial. Next, our phase 2A study of tegoprubart in adults with an IgAN continues to enroll, and we're expanding the enrollment landscape from our current 9 countries with 17 sites into another 3 additional countries, including the United States and China.

With an eye to further progressing AOS clinical development, we will be working with opinion leaders the patient community and regulators on potential next steps as well as looking at different approaches to fund a potential future drops.

Next our phase Iia study to Gopro in adults with eight again continues to enroll and we're expanding the enrolment landscape from our current nine countries with 17 sites.

Another three additional countries, including the United States and China.

David-Alexandre Gros: Based on the enrollment progress to date, we expect to fully enroll the high-dose cohort in H1 2023. Our goal is to provide meaningful insights into tegoprubart's clinical activity after 24 weeks of therapy in this indication, and we thus anticipate reporting initial six-month open label data from this study in Q1 2023. Turning to islet cell transplantation. In June, tegoprubart was granted Orphan Drug Designation by the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation. This represents a significant regulatory milestone for this program as we plan to open a clinical site at the University of Chicago in the coming month. We believe that this will be a major catalyst in the enrollment process going forward.

Based on the enrollment progress to date, we expect to fully enroll the high dose cohort in the first half of 2023.

Our goal is to provide meaningful insights, it's a global parts clinical activity. After 24 weeks of therapy in this indication and we don't anticipate reporting initial six month open label data from this study in the first quarter of 2023.

Yeah.

Turning to I'll, let cell transplantation.

<unk> was granted orphan drug designation by the FDA for the prevention of allograft rejection in pancreatic islet cell transplantations.

It represents a significant regulatory milestone for this program as we plan to open a clinical site at the University of Chicago.

In the coming months.

We believe that this will be a major catalyst in the enrollment process going forward.

David-Alexandre Gros: With the planned opening of the Chicago clinical site. In order to more efficiently focus our resources, we made the decision to close the existing clinical site in Alberta, Canada. We believe the new clinical site in Chicago will be sufficient to enroll the study of up to six participants with type 1 diabetes, and we anticipate reporting initial 3-month open label data from this study in Q1 2023. I'll now turn over the call to Jeff Bornstein, our Chief Medical Officer, to provide additional details on our development program. Jeff?

With the planned opening of the Chicago clinical site and in order to more efficiently focus our resources, we made the decision to close the existing clinical site Berta Canada.

We believe the new clinical site in Chicago will be sufficient to enroll the study of up to six participants with type one diabetes.

And we anticipate reporting initial three month open label data from this study in the first quarter of 2023.

I'll now turn over the call to Jeff Bornstein, our Chief Medical officer to provide additional details on our development program.

Jeff.

Jeff Bornstein: Thank you, D.A. I'd like to begin by discussing our recent kidney transplant efforts. The cornerstone for the prevention of transplant rejection is the utilization of CNIs, even though CNIs are associated with significant side effects, including beta cell toxicity causing new onset diabetes, neurotoxicity causing neurological symptoms including tremors and decreased cognitive function, as well as an increased risk of heart disease. Additionally, the chronic utilization of CNIs to prevent graft rejection has been associated with significant nephrotoxicity, which can impair graft function and even shorten graft survival in the same organs those CNIs are being taken to protect. By improving the safety and tolerability of first-line immunosuppression, Tegoprubart has the potential to both improve patient quality of life and reduce overall morbidity in the near term, as well as ultimately improve graft survival rates in the long term.

Thank you.

I'd like to begin by discussing our kidney transplant effort.

Cornerstone for the prevention of transplant rejection is the utilization of C&I, even those C&I are associated with significant side effects, including beta cell toxicity, causing new onset diabetes, neurotoxicity, causing neurological symptoms, including tremors and decreased cognitive function as.

As well as an increased risk of heart disease.

Jeff Bornstein: Additionally, the chronic utilization of CNIs to prevent graft rejection has been associated with significant nephrotoxicity, which can impair graft function and even shorten graft survival in the same organs those CNIs are being taken to protect. By improving the safety and tolerability of first-line immunosuppression, Tegoprubart has the potential to both improve patient quality of life and reduce overall morbidity in the near term, as well as ultimately improve graft survival rates in the long term.

Additionally, a chronic utilization in C&I.

Protection.

Associated with significant muscle toxicity, which can in paragraph function, even shorten graft survival and the same organ of C&I.

Correct.

Improving the safety and Tolerability of first line immunosuppression.

<unk> has the potential to both improve patient quality of life.

And reduce overall morbidity in the near term.

Well ultimately improve perhaps the following in Milan.

Jeff Bornstein: We are particularly enthused about our kidney transplant efforts because of the large amount of non-human primate data generated both by ourselves with tegoprubart as well as with historic anti-CD40 ligand antibodies. In these studies, non-human primates treated with anti-CD40 ligand antibodies as monotherapy demonstrated protection from rejection for months at a time, versus only days in untreated animals. As D.A. mentioned, we recently dosed the first patient in our phase 1b clinical trial of tegoprubart in kidney transplantation. This 52-week open label study with sites in Canada, the United Kingdom, and Australia is enrolling up to 12 patients undergoing renal transplant, with primary endpoints of safety and pharmacokinetics, as well as exploratory endpoints, including biopsy-proven acute rejection, change in eGFR, and biomarkers of inflammation and kidney rejection.

We are particularly in thinking about our kidney transplant efforts because of the large amount of nonhuman primate data generated both by ourselves.

As well as historic anti CD 40 ligand antibodies.

In these studies non human primates treated with anti CD 40 ligand antibody as monotherapy demonstrated protection from rejection for months at a time.

The only date in untreated animals.

As Deanna mentioned, we recently dosed the first patient in our phase <unk> clinical trial of <unk> in kidney transplantation.

Its 52 week open label study with banks in Canada, the United Kingdom, and Australia is enrolling up to 12 patients undergoing renal transplant with primary endpoints of safety and pharmacokinetics as well as exploratory endpoints, including biopsy proven acute rejection change in Egfr and biomarkers of inflammation.

Kidney rejection.

Jeff Bornstein: Our goal is to demonstrate that tegoprubart can be safely utilized to replace CNIs as part of first-line immunosuppressive therapy in solid organ transplantation, and prevent acute and long-term solid organ transplant rejection without the use of CNIs. With enrollment ongoing, we aim to provide initial 3-month and 6-month open label data across multiple transplant participants in Q1 2023. These time points are relevant since acute rejection most often occurs within the first 90 days of the transplant, and new onset diabetes post-transplant often begin to be seen at 6 months. In addition, we were pleased to recently announce a regulatory milestone with the clearance of tegoprubart's US IND application to evaluate tegoprubart for the prevention of rejection in kidney transplant recipients.

Our goal is to demonstrate that <unk> can be safely utilize to replace DNI as part of first line immunosuppressive therapy, and solid organ transplantation and prevent acute and long term solid organ transplant rejection without the use of C&I.

With enrollment ongoing we aimed to provide initial three month and six month open label data across multiple transplant participant in the first quarter of 2023.

These time points are relevant since acute rejection most often occurs within the first 90 days of the transplant and new onset diabetes post transplants, often begin to be seen at six months.

In addition, we were pleased to recently announce a regulatory milestone with the clearance of <unk> application to evaluate to go for a buyer for the prevention of rejection in kidney transplant recipients.

Jeff Bornstein: The IND opening phase 2 study will be a multicenter, open label, 2-arm, active comparator safety pharmacokinetic and efficacy study that will enroll approximately 120 participants, 50 per arm, undergoing kidney transplants. Participants will receive tegoprubart or the active comparator tacrolimus as part of an immunosuppressive regimen, including corticosteroids and mycophenolate mofetil or mycophenolate sodium. The study's primary objective is to assess whether graft function at 12 months post-transplant in tegoprubart-treated participants is superior to tacrolimus-treated participants. The primary endpoint will compare the mean estimated glomerular filtration rate, eGFR, at 12 months for tegoprubart versus current standard of care. Graft function, as assessed by eGFR at 12 months post-transplant, is associated independently with subsequent graft failure.

The IMT opening phase II study will be a multicenter open label two arm active comparator safety pharmacokinetic and efficacy studies.

That will enroll approximately 120 to 120 participants to keep her arm undergoing kidney transplants.

Participants will receive <unk> or the active comparator to Colo.

As part of an immunosuppressive regimen, including corticosteroids and multifamily market sell our multifamily $30.

The study's primary objective is to assess whether graph function at 12 months post transplant and scope of our treated park.

And superior to Korlym is treated participant.

The primary endpoint will compare the mean estimated glomerular filtration rate Egfr.

12 months for <unk> versus current standard of care.

Ralph function as assessed by Egfr at 12 months post transplant is associated independently the subsequent graft failure.

Jeff Bornstein: GFR has been established as an indicator of kidney function in both pre- and post-transplant patients, and lower levels are associated with need for dialysis and transplantation or retransplantation. Secondary objectives include safety, incidence of new onset diabetes, biopsy-proven acute rejection, and graft survival. We will provide further information on the timing of this study later this year. Of note, the phase 2 program includes an open-label extension study allowing for the collection of long-term efficacy and safety from both this study as well as the ongoing phase 1 B study. We expect to run both the phase 1 B and the phase 2 studies in parallel so we can continue to report data and insights on tegoprubart from the phase 1 B study while the phase 2 is running.

CFR has been established as an indicator of kidney function in both pre and post transplant patients.

And lower levels are associated with the need for dialysis and transplantation or re transplantation.

Secondary objectives include safety incidents of new onset diabetes biopsy proven acute rejection and participant in graft survival.

We will provide further information on the timing of this study later this year.

Okay.

Of note the Phase III program includes an open label extension study, allowing for the collection of long term efficacy and safety from both this study as well as the ongoing phase <unk> study, we expect to run both the phase <unk> and the phase III studies in parallel. So we can continue to report data and insights on scope of our phase <unk> study.

While the phase two is running.

Okay.

Jeff Bornstein: Next, I'll move on to ALS and recap the positive top-line data we announced from our Phase 2a trial evaluating tegoprubart in ALS. This was a significant milestone for Eledon as it demonstrated the safety and tolerability of tegoprubart, provided insights into the role and potential impact of tegoprubart in ALS, and also helped furnish some potential read-throughs for tegoprubart to other indications with overlapping biomarkers. The study was an open-label, multiple ascending dose study that sequentially evaluated 1 milligram per kilogram, 2 milligrams per kilogram, 4 milligrams per kilogram, and 8 milligrams per kilogram of tegoprubart administered every two weeks via IV infusion for a total of six infusions.

Next I'll move on to AOS and recap the positive top line data, we announced from our phase Iia trial evaluating <unk> in.

This was a significant milestone for <unk> and the demonstrated the safety and Tolerability of two both of ours.

Provided insight into the role and potential impact to <unk>.

And also help furnish some potential read throughs for <unk> to other indications with overlapping biomarkers.

Study was an open label multiple ascending dose studies sequentially evaluated one milligram per kilogram.

<unk> per kilogram.

<unk> milligrams per kilogram and <unk> eight milligrams per kilogram of <unk> administered two weeks every two weeks via IV infusion for a total of <unk>.

Jeff Bornstein: In the two lower dose cohorts, we enrolled nine participants per group, and as we dose escalated, we moved to 18 participants per cohort as the higher two doses were where we had projected to see the biomarker effect. We collected blood samples at screening and just prior to first infusion for each participant, as well as prior to each subsequent infusion, so that each participant can serve as their own control in the study. The primary endpoint of the study was safety and tolerability, with a range of secondary and exploratory endpoints measuring biomarker activity for target engagement, changes in proinflammatory chemokine and cytokine upregulated in people living with ALS, and changes in ALS Functional Rating Scale, or the ALSFRS.

And the two lower dose cohorts enrolled nine participants per group.

And as we dose escalated we moved to 18 18 participants per cohort as the higher doses.

Where we had projected to see the biomarker fat.

We collected blood samples of screening and just prior to first infusion for each participant.

As well as prior to each subsequent infusion so that each participant can serve as their own control study.

Primary endpoint of the study was safety and Tolerability with a range of secondary and exploratory endpoints measuring biomarker biomarker activity our target engagement.

Changes in pro inflammatory chemo cytokine up regulated in people living with ALS and changes in ALS functional rating scale or the ALS FRS.

Jeff Bornstein: The data showed that tegoprubart successfully met the primary endpoint of safety and tolerability, with no serious or severe adverse events related to study drug and adverse events being generally consistent with what is expected in a population of ALS participants. Importantly, there were no signs of platelet activation or thrombosis in the participants, and anti-drug antibodies were present in less than 5% of samples, all of which were of low titer and did not impact tegoprubart drug levels. Tegoprubart target engagement, as measured by a statistically significant reduction in CD40 ligand, a marker of T cell activity, and CXCL13, a marker of B cell activity, was achieved in a dose-dependent fashion, with the largest mean reductions occurring in the two higher dose cohorts. In addition, we also observed an increase in the percentage of participants who showed a reduced level of these biomarkers in a dose-dependent manner.

The data showed that <unk> successfully met the primary endpoint of safety and Tolerability.

With no serious or severe adverse events related to study drug and adverse events being generally consistent with what is expected in a population of ALS.

Importantly, there were no signs of platelet activation of thrombosis and the participants in.

An anti drug antibodies were present in less than 5%.

All of which were up low titer and did not impact to go prove our drug levels.

Jeff Bornstein: Tegoprubart target engagement, as measured by a statistically significant reduction in CD40 ligand, a marker of T cell activity, and CXCL13, a marker of B cell activity, was achieved in a dose-dependent fashion, with the largest mean reductions occurring in the two higher dose cohorts. In addition, we also observed an increase in the percentage of participants who showed a reduced level of these biomarkers in a dose-dependent manner.

Scope of our target engagement as measured by a statistically significant reduction.

<unk> hundred 40 <unk>.

A marker of T cell activity and <unk> a marker of these activity was achieved in a dose dependent.

With the largest mean reduction occurring in the two higher dose cohorts. In addition.

We also observed an increase in the percentage of participants we showed a reduced level of these biomarkers in a dose dependent manner.

Jeff Bornstein: Prior to launching the trial, we identified six proinflammatory proteins that have been described in the literature to be elevated in people with ALS, including TNF-alpha, MCP-1, IL-6, IL-1, RAGE, and CRP. We were highly encouraged to see significant reductions in four of the six of these proinflammatory markers, including TNF-alpha, MCP-1, RAGE, and CRP. In addition to these ALS-associated biomarkers, we observed a total reduction in 23 of the 32 proinflammatory proteins we detected, including myeloid markers CXCL9 and CXCL10, as well as complement C3 and the B cell markers IgA, IgE, and IgM. These additional biomarkers are of note since they play an important role in our other disease programs. IgA, C3, and CD40 ligand have been associated with disease progression and proteinuria in patients with IgAN, while CXCL9, CXCL10, IgM, and C3 have been associated with kidney transplant rejection.

Prior to launching the trial, we identified six pro inflammatory proteins.

And that have been described in the literature to be elevated and people with Atlas.

Including TNF Alpha MTV, one IL, six IL, one and rates and CRP.

We were highly encouraged with the significant reduction in four of the six of these pro inflammatory markers.

Including TNF Alpha MCP, one and rates in CRB.

In addition to these alpha associated Biomarkers.

We observed a total reduction in 23 of 32 pro inflammatory proteins, we detected.

Including myeloid marker DXP online MTX field tests.

As well as complement <unk> III and the B cell markers Iga IGT IGN.

These additional biomarkers are of note.

Play an important role in our other disease programs.

<unk> hundred 40 ligand have been associated with disease progression on protein area and patients with ICANN.

<unk> <unk> <unk> and <unk> have been associated with kidney transplant rejection.

Jeff Bornstein: Lastly, as part of the exploratory endpoints, we reported that tegoprubart's target engagement and level of reduction in proinflammatory biomarkers are associated with a trend in slowing down of disease progression as measured by ALSFRS slope when compared to a cohort from the ALS PRO-ACT database. This database is a publicly available data collection from historical ALS clinical trials containing demographic data as well as clinical outcome measures, including ALSFRS. We found that participants with positive target engagement, defined as those who had at least a 10% decrease in CXCL13, trended toward a greater slowing of ALSFRS slope when compared to those who did not achieve target engagement. These data taken together suggest the inhibition of CD40 ligand signaling by tegoprubart results in a decrease in proinflammatory biomarkers that may result in a slowing of disease progression.

Lastly.

As part of the exploratory endpoints, we reported that to Gopro bar target engagement and level of reduction pro inflammatory biomarkers are associated with a trend slowing down of disease progression.

As measured by ALS FRS.

Hello, when compared to a cohort from the AOS Pro Act database.

This database is a publicly available data collection historical ALS clinical trials.

Turning demographic data.

Well as clinical outcome measures, including Alex Tomorrow.

Jeff Bornstein: We found that participants with positive target engagement, defined as those who had at least a 10% decrease in CXCL13, trended toward a greater slowing of ALSFRS slope when compared to those who did not achieve target engagement. These data taken together suggest the inhibition of CD40 ligand signaling by tegoprubart results in a decrease in proinflammatory biomarkers that may result in a slowing of disease progression.

We found that participants with positive target engagement defined as those who had at least a 10% decrease in <unk> <unk>.

Trended toward a greater slowing of ALS FRS load.

When compared to those who did not achieve target engagement.

These data taken together suggest inhibition of <unk> hundred 40 <unk> signaling.

Bart resulted in a decrease in pro inflammatory Biomarkers that may result in slowing of disease progression.

Jeff Bornstein: We are very encouraged by these results, which further demonstrate the safety and tolerability of tegoprubart through the highest dose cohort. We also believe that showing a relationship between target engagement, reduction in proinflammatory markers, and change in disease progression measured by ALSFRS-R is an important signal in this devastating disease that further validates our confidence in tegoprubart's immunomodulatory potential in ALS. Finally, we look forward to presenting our data at an upcoming ALS conferences later this year. Moving to IgAN. We believe in the strong mechanistic rationale for pursuing CD40 ligand inhibition in IgAN due to tegoprubart's potential ability to show beneficial effects on both the upstream and downstream pathophysiology of IgAN.

We are very encouraged by these results, which further demonstrates the safety and Tolerability of <unk>.

Through the highest dose cohort.

We also believe that selling a relationship between target engagement production in pro inflammatory markers and change in disease progression measured by <unk>.

As an important signal in this devastating disease that further validates our confidence in CECO provides immuno muscled sorry potential in Atlas.

Finally, we look forward to presenting our data.

Upcoming TALF conferences the sleigh.

During this year.

Moving to <unk>.

We believe in the strong mechanistic rationale for pursuing <unk> 40, ligand inhibition ni yen due to scope about potential ability.

<unk> beneficial effects on both the upstream and downstream pathophysiology of IBM.

Jeff Bornstein: While the current standard of care and other drugs in development generally aim to either reduce production of antibodies or to alter kidney hemodynamics to reduce protein loss and tissue damage, tegoprubart has the potential to impact multiple steps in the pathophysiology. Excuse me. In fact, multiple steps in the pathophysiology by reducing production of IgA antibodies, reducing the production of anti-IgA IgG antibodies, reducing immune complex formation, and reducing cellular inflammation in the glomerulus itself. We are happy to report that we continue to dose patients in our open-label phase IIa clinical trial in patients with IgAN. We have been actively engaged with regulators across the world and now have approval for clinical trial sites in nine countries, with plans to expand into up to three additional countries, including United States and China.

While the current standard of care in other drug development generally aimed to reduce production of antibodies.

Or to alter kidney hemodynamics to reduce protein loss and tissue damage <unk> has the potential.

To impact multiple steps in the pathophysiology.

Yeah.

In fact, multiple Kathryn the pathophysiology are reducing production of Iga antibodies.

Reducing the production anti Iga ITG antibody, reducing immune complex formation.

And reducing cellular inflammation in the Colombia itself.

We are happy to report that we continue to dose patients in our open label Phase Iia clinical trial in patients with ICANN.

We have been actively engaged with regulators across the world.

And now have approval for clinical trial sites in nine countries with plans to expand into up to three additional countries.

Including the United States and China.

Jeff Bornstein: This global study is a 96-week open label trial that will include 42 total participants in high dose and a low dose cohort. The primary endpoint is change in the urinary protein to creatinine ratio, or UPCR, at week 24. Secondary endpoints include change in estimated glomerular filtration rate at week 96, as well as safety and tolerability. Based on enrollment trends to date, we anticipate fully enrolling the first cohort of this study in H1 2023. We believe it is important to accumulate 24 weeks of clinical data across multiple patients in this indication in order to properly evaluate tegoprubart's potential. Therefore, we anticipate reporting initial 6-month open label data from this study late in Q1 2023.

This global study the 96 week open label trial.

And that will include 42, total participants and high dose and a low dose cohort.

The primary endpoint is change in the urinary protein to creatinine ratio or <unk> at week 24.

Secondary endpoints include change in estimated primary local attrition rate at week 96.

As well as safety and Tolerability.

Based on enrollment trends to date, we anticipate fully enrolling the first cohort of this study.

In the first half of 2023, we believe it is important to accumulate 24 weeks of clinical data across multiple patients.

In this indication in order to properly evaluate to cope with partners.

And therefore, we anticipate reporting initial six month open label data from this study late in the first quarter of 2023.

Jeff Bornstein: I'll wrap up my update by turning to islet cell transplantation and our phase 2A trial for the prevention of allograft rejection, where we are about to open our US site at the University of Chicago. We believe this new site will be a critical step to jumpstart the enrollment process of this study by allowing us to concentrate resources and close our Canadian site. A key advantage of the Chicago site is its focus on these novel types of approaches, since islet cell transplantation is considered experimental in the United States, and we are confident that the new clinical site in Chicago will be sufficient to enroll the study of up to 6 participants. This site will be actively screening for type 1 diabetic patients with hypoglycemic unawareness who experience significant swings in glucose levels that are associated with serious risks and comorbidities.

I'll wrap up my update by turning to islet cell transplantation.

In our phase Iia trial for the prevention of Allograft rejection, where we are about to open our U S site at the University of Chicago.

We believe this new site will be a critical depth to jumpstart the enrollment process of this study.

Loud enough to concentrate resources on close our Canadian site.

A key advantage of the Chicago site.

The focus on these novel types of approaches and pilot cell transplantation considered experimental in United States.

And we are confident that the new clinical site in Chicago will be sufficient to enroll the study up to six purchases.

This site will be actively screening for type one diabetic patients with hypoglycemic and awareness.

Who experienced significant swings in glucose level at our associated with serious risks and comorbidities.

Jeff Bornstein: Our goal is to evaluate tegoprubart as the backbone of maintenance anti-rejection therapy similar to the design for kidney transplantation. In ICT specifically, we are also evaluating the ability of patients to achieve insulin independence, as well as the number of islet cell transplants required to achieve independence. We believe that by removing CNIs, which are directly toxic to the islet cells, and replacing with tegoprubart, more patients may be able to achieve better glycemic control with fewer islet cell transplants. With the opening of our first US site, we are looking to enroll the first patients in the phase 2a islet cell transplantation trial and aim to provide available three-month data in Q1 2023. With that, I'll now turn the call over to Paul for a financial update.

Our goal is to evaluate to go provider is the backbone of maintenance Antirejection therapy.

Similar to the design for kidney transplantation.

And ICT specifically, we are also evaluating the ability of patients to achieve insulin dependence.

As well as the number of islet cell transplants required to achieve independence, we believe that by removing C&I, which are directly toxic to the islet cells.

And replacing with typical more patients may be able to achieve better glycemic control with fewer highlight cell transplants.

With the opening of our first U S site, we are looking to enroll first patient in the phase Iia islet cell transplants safety trial and aim to provide available three month data in the first quarter of 2023.

With that I'll now turn the call over to Paul for our financial update.

Paul Little: Thank you, Jeff. In addition to the financial results summarized in our press release, you can find additional information in our Form 10-Q, which we will file later today. The company reported a net loss of $9.2 million, or $0.65 per share for the three months ended 30 June 2022, compared to a net loss of $7.4 million, or $0.50 for the same period in 2021. Research and development expenses were $5.7 million for the three months ended 30 June 2022, compared to $4.2 million for the comparable period in 2021, which was an increase of $1.5 million.

Thank you Jeff in.

In addition to the financial results summarized in our press release, you can find additional information in our Form 10-Q, which we will file later today.

The company reported a net loss of $9 2 million or 65 cents per share for the three months ended June 32022, compared to a net loss of $7 4 million or <unk> for the same period in 2021.

Research and development expenses were $5 7 million for the three months ended June 32022, compared to $4 2 million for the comparable period in 2021, which was an increase of $1 5 million.

Paul Little: The increase was primarily due to an increase in clinical development costs of $600,000, primarily with external CROs as we advance our tegoprubart programs, and an increase in consulting expenses of $800,000, as well as personnel costs of $200,000 due to an increase in headcount and stock-based compensation costs. G&A expenses were $3.5 million for the three months ended 30 June 2022, compared to $3.7 million for the comparable period in 2021, a decrease of $200,000. Looking at the cost side of our business, we continue to remain diligent in the control of our discretionary spending, and this reduction in year-over-year G&A spend is a reflection of these ongoing efforts.

The increase was primarily due to an increase in clinical development costs of 600000, primarily with external <unk> as we advance our <unk> programs and then an increase in consulting expenses of $800000 as well as personnel costs of $200000.

Due to an increase in head count and stock based compensation costs.

G&A expenses were $3 5 million for the three months ended June 32022, compared to $3 7 million for the comparable period in 2021, a decrease of 200000 looking at the cost side of our business. We continue to remain diligent in the control of our discretionary spending and this reduction in year over year G&A spend as it reflects.

Of these ongoing efforts.

Paul Little: As of 30 June 2022, Eledon had $70.5 million in cash and cash equivalents, which we expect to be sufficient to fund our clinical trial operations as currently planned into 2024. Our cash runway allows us to initiate the phase 2 trial of tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant, but additional financing will be required to fund any future ALS clinical trials. With that financial update, let me turn the call back over to DA.

As of June 32022, Eligon had $75 million in cash and cash equivalents, which we expect to be sufficient to fund our clinical trial operations. As currently planned into 2024, our cash runway allows us to initiate the phase II trial of <unk> for the prevention of organ rejection in patients receiving a kidney transplant.

But additional financing will be required to fund any future Pls clinical trials with that financial update let me turn the call back over to da.

David-Alexandre Gros: Thanks, Paul. As we discussed today, we are encouraged by the progress we made this quarter throughout our pipeline, and we are excited to continue the positive momentum generated in the H1 of this year. We believe the first of our four tegoprubart clinical readouts demonstrated not only the potential to treat ALS, but also a broader range of inflammation-related indications by targeting the CD40 ligand pathway. Through the remainder of the year, we will be focused on enrollment across our three ongoing trials, as well as preparing for the launch of our larger phase 2 kidney transplantation study. We look forward to providing meaningful data updates for each program starting in Q1 2023. I'll now ask the operator to begin our Q&A session. Operator?

Thanks, Paul.

As we discussed today, we are encouraged by the progress we made this quarter throughout our pipeline and we are excited to continue the positive momentum generated in the first half of this year.

We believe the first of our <unk> clinical readouts demonstrated not only the potential to treat ALS, but also a broader range of inflammation related indications by targeting the CD 40 ligand pathway.

Through the remainder of the year, we will be focused on enrollment across our three ongoing trials as well as preparing for the launch of our larger phase II kidney transplantation study.

We look forward to providing meaningful data updates for each program starting in the first quarter of 2023.

I'll now ask the operator to begin our Q&A session operator.

Operator: Yes, thank you. At this time, we will begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble the roster. The first question comes from Thomas Smith with SVB Securities.

Yes. Thank you at this time, we will begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.

If you are using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.

At this time, we will pause momentarily to assemble the roster.

And the first question comes from Thomas Smith with SPP Securities.

Thomas Smith: Hey, guys. Good afternoon. Thanks for taking the questions. Just I guess first on the updated data timelines, you know, I understand there are a lot of moving parts here, but can you provide any thoughts on how many patients we can expect to see across each of these initial data sets in Q1 2023?

Hey, guys. Good afternoon. Thanks for.

Taking the questions just I guess first on.

The updated data timelines I understand there are a lot of moving parts here, but can you provide any thoughts on how many patients. We can expect to see across each of these initial datasets in Q1 'twenty three.

David-Alexandre Gros: Hey, Tom, and thanks for the question. We expect to get the same number of patients that we've been discussing in the past. It's really just a slight change. As you know, beforehand, we had been talking about late this year, with the timing of when we started enrollments, in transplant and in IgAN in order to make sure that we have sufficient patients, that just delays us slightly into Q1.

Hey, Tom and thanks for the question.

We expect to get the same number of patients that we've been discussing in the past.

And it's really just a slight change so as you know beforehand, we had been talking about late this year.

The timing of when we started enrollment.

Ed in transplant, and then again in order to make sure that we have sufficient patients that just delays us slightly into the first quarter.

Thomas Smith: Okay.

So.

David-Alexandre Gros: The target is to have a few patients in the transplant indications and then a handful of patients with six months of data in IgAN.

We should have the target is to have a few patients.

In the transplant indications and then a handful of patients with six months of data.

Again.

Thomas Smith: Okay. Got it. On islet cell transplant, can you just talk a little bit more about the team at the University of Chicago, and I guess just give us a sense, you know, are they actively performing these procedures today as part of other clinical studies? If they are, kind of what the volume of that might be. I guess your thoughts around, you know, potentially expanding out to other centers in the US. You know, I think there are, you know, 15 to 20 other academic centers that, you know, are performing these procedures, but just curious how you guys are thinking about expansion of this program.

Okay got it and then.

On islet cell transplants.

And just talk a little bit more about the.

The team at the University of Chicago, and I guess, just give us a sense are they <unk>.

<unk> performing these procedures today as part of other clinical studies and if they are kind of what the volume of that might be and then.

Just your thoughts around potentially expanding.

The other centers in the U S. I think there are.

15% to 20 other academic centers that.

<unk> are performing these procedures, but just curious how you guys are thinking about.

Expansion of this program.

David-Alexandre Gros: Sure. Maybe I'll start with the second part, and then Jeff, I'll turn it over to you to talk about the first part of the question on the University of Chicago. To answer your question about expanding right now, we're looking to focus on the University of Chicago, and because our IND includes cell manufacturing, right now that's specific to this site. The goal is to see if, and we believe we'll be able to begin to enroll and to get traction in Chicago. Over time, of course, we can revisit and think about where else we may go. Now, Jeff, I'll turn the call over to you.

Sure. So maybe I'll start with the second part and then Jeff I'll turn it I'll turn it over to you.

To talk about the first part of the question on the University of Chicago.

To answer your question about expanding right now.

We're looking to we're looking to focus on the University of Chicago.

And because our R&D includes cell manufacturing.

Right now Thats specific.

To this site.

So the goal is to see it.

And we believe we'll be able to begin to enroll and to get traction.

In Chicago, and then over time of course, we can revisit.

And think about where else we may go.

No Jeff I'll turn the call over to you in terms of the site.

Jeff Bornstein: Yeah.

David-Alexandre Gros: in terms of the site.

Jeff Bornstein: All right. Thank you, DA. Thanks, Tom. The University of Chicago is very active. They've been involved in islet cell transplant for many years. They've done it under their own experimental protocols, as well as protocols with other sponsors. They are active right now. They are very confident that they can enroll our study, and we've enjoyed working with them, their collaborative spirit, and their enthusiasm. We're very confident in them.

Alright, thank you thanks.

Thanks, Tom.

University of Chicago is very active they've been.

<unk> been involved in I will tell transplant for many years they've done it in their own under their own experimental protocol.

As well as protocols with other other sponsors are they are active right now.

And so.

They are very confident that they can enroll on our study and we've enjoyed working with them in their collaborative spirit and their enthusiasm. So we are we're very confident in them.

David-Alexandre Gros: The PI is the same person who presented at our R&D Day.

And the pie the same person there as the same person who presented at our R&D day.

Okay.

Thomas Smith: Okay, great. Got it. Then just lastly on the renal transplant program, and congrats on the progress here with the first patient dose and the recent IND clearance. Can you share any feedback on your engagement with FDA and maybe just some of the thought process behind running the larger phase II program in parallel with the ex US open label program?

Okay, Great got it and then just.

Lastly on the on the renal transplant program and congrats.

Congrats on the progress here, but the first patient dosed in the recent 90 clearance can you.

Can you share any feedback on your engagement with FDA and maybe just some of the thought process behind running the larger phase II program in parallel with the ex U S Open label program.

David-Alexandre Gros: Sure. We can't share much about discussions, but perhaps what we can do is talk about how we ended up opting for a superiority study. Jeff, why don't I turn that over to you?

Sure. So we can't share much about.

About discussions, but perhaps when.

When we can do is talk about how we ended up.

Okay.

Opting for superiority study.

Yeah.

Jeff why don't I turn that over to you.

Jeff Bornstein: Sure. Yeah. Thank you, DA. So the thought process behind the design of the study was that it provides certain advantages. Superiority will allow us to design a smaller study, but also at the same time, perhaps, have some longer-term commercial advantages there. The agency did give us feedback around trial design and did guide us in that direction. From our point of view, regardless of what phase 3 looks like, this study is gonna be big enough and inform on the right endpoint to enable the correct design, whether that's a confirmatory trial that confirms this design or whether we have to switch to a different endpoint. We believe that this is designed to inform all of it.

Sure Yes. Thank you Dan so the thought process behind the design of the study.

Is that it provides certain advantages.

Periodically.

We will allow us to design a smaller study, but also at the same time, perhaps.

Some longer term commercial advantages there the agency did give us feedback around trial design and did guide us in that direction.

And.

From our point of view, regardless of what phase three looks like this study is going to be big enough and inform on the right endpoint.

<unk> enable the correct design whether thats.

Confirmatory trial all of that came from this design or whether we have to switch to a different endpoint. We believe that this is designed to inform all of it.

Thomas Smith: Okay, great.

David-Alexandre Gros: And to your-

Thomas Smith: That's super helpful.

Okay, Great that's super helpful.

David-Alexandre Gros: To your question about the Phase 1b study, we plan to run, as we discussed, both in parallel. The advantage of doing that is that it's going to allow us to continue learning about tegoprubart, and it'll also give us a way to continue to report data about the performance of tegoprubart in kidney transplant while the larger study is running.

To your question about the Phase <unk> study, we plan to run as we discussed both in parallel.

And the advantage of doing that is that it's going to allow us to continue learning about to go through.

The lawsuit give us a way to continue to report data about the performance to go from BARDA in kidney transplant, while the larger study is running.

Okay.

Thomas Smith: Got it. Understood. All right, guys. Thanks for taking the questions. Appreciate it.

Got it understood alright, guys. Thanks for taking the questions I appreciate it.

David-Alexandre Gros: Thanks, Tom.

Thanks, Tom.

Operator: Thank you. The next question comes from Romir Kathuria with LifeSci Capital.

Thank you and our next question comes from Robert <unk> with lifestyle capital.

Romir Kathuria: Hey, guys. Congrats on the recent updates, and thanks for taking my questions. Two quick ones for me. First, to clarify on a previous point, is mean eGFR potentially an improvable endpoint in a potential phase III study, or are you still gonna have to focus on kind of graft survival long term?

Rami Katkhuda: Hey, guys. Congrats on the recent updates, and thanks for taking my questions. Two quick ones for me. First, to clarify on a previous point, is mean eGFR potentially an improvable endpoint in a potential phase III study, or are you still gonna have to focus on kind of graft survival long term?

Hey, guys. Congrats on the recent updates and thanks for taking my question.

Two quick ones for me first to clarify on a previous point.

Is mean egfr potentially an approvable endpoint in a potential phase III study or are you still going to have to focus on kind of graft survival long term.

David-Alexandre Gros: Sure. Jeff, why don't I turn that over to you?

Sure So Jeff why don't I turn that over to you.

Jeff Bornstein: Yeah, sure. Thank you. As you're probably aware, the precedent in this space has been non-inferiority in phase 3, focusing on graft rejection, and patient and graft survival. The mean change in eGFR has not been used to support approval, but that doesn't necessarily mean that it can't be in the future. Our plan is to look at the data we have, and keep engaging with the agency. Like I said in response to the previous question, we'll be ready with the data from this trial whichever pathway that takes us down.

Yeah sure. Thank you so <unk>.

As Youre, probably aware the precedent in this space has been non inferiority.

In phase III.

Focusing on <unk>.

Rejection in patient graft survival.

The mean <unk>.

Change in Egfr has not been used to support approval.

That doesn't necessarily mean that it can't be in the future and so we our plan is to look.

At the data, we have and keep engaging with the agency and like I said on the response to.

Previous question, we'll be ready with the data from this trial whichever pathway.

Okay.

Romir Kathuria: Got it. That makes a lot of sense. Tacrolimus, this is obviously nephrotoxic, as we've talked in the past, but can you quantify how much the treatment usually affects eGFR patients receiving a kidney transplant in the first year?

Rami Katkhuda: Got it. That makes a lot of sense. Tacrolimus, this is obviously nephrotoxic, as we've talked in the past, but can you quantify how much the treatment usually affects eGFR patients receiving a kidney transplant in the first year?

Got it that makes a lot of sense and then.

<unk>, obviously never toxic as we've talked on the past, but can you quantify how much the treatment usually affect egfr patients receiving a kidney transplant in the first year.

David-Alexandre Gros: Jeff?

Jeff Bornstein: I can take that, D.A. Yeah, thanks. It's variable, of course, patient to patient, and also depends somewhat on the quality of the graft that they got. Looking at datasets from published data and also from head-to-head trials with, for example, the Belatacept trial, the mean GFR in CNI-treated patients typically is lower and tends to decline. That rate of decline, again, is different in different individual patients, but it is predictive. There's data showing that if the eGFR at one year is below a threshold of 50 mL/min per body surface area, that is predictive of poor graft function in the long run and even graft loss.

Yes.

I can take that.

So.

Yes.

Variable of course patient to patient and also depends somewhat on on the quality of the graph that they bought but looking at data sets.

From published data and also from head to head trials with.

For example, the <unk> trial, the mean GFR.

In.

C&I treated patients.

Typically is lower and tends to decline.

That rate of decline again with different different different individual patients, but it is predictive there.

There is data showing that.

The Egfr at one year is below a threshold of.

50, 50 ml per minute per body surface area.

That is predictive of poor graft function in the long run and even graft loss.

Jeff Bornstein: The lower you go, the worse, the higher the risk of that bad outcome. It is predictive, and that's not surprising because it's predictive and it's used as a validated surrogate in non-transplant indications, right? If you look at the IgAN program, the ultimate endpoint is GFR. Proteinuria is the surrogate that's reasonably likely to predict. The reason that GFR is the ultimate endpoint is that it's known. It's known as an effective stand-in for the clinical outcomes of dialysis and kidney failure. It's not surprising that the GFR can predict that. Consistently, calcineurin-exposed patients do have lower GFRs, and their GFRs decline over time.

And the lower you go the worse the higher the risk of that bad outcome. So it is predictive and thats not surprising.

Because its predictive and it's used as a validated surrogate and non transplant indications right. If you look at the.

<unk> program, the ultimate endpoint as GFR and proteinuria as a surrogate that's reasonably likely to predict and the reason the GFR was the ultimate endpoint is that it's no.

Known as effective stand in for the clinical outcomes.

Dialysis and kidney failure.

It's not surprising that the GFR can predict that and consistently Catherine.

Both patients do have lower GFR is in there.

This decline over time.

Romir Kathuria: Got it. Thanks so much.

Rami Katkhuda: Got it. Thanks so much.

Okay.

Got it thanks, so much.

Operator: Thank you. The next question comes from Matt Kaplan with Ladenburg Thalmann.

Thank you and our next question comes from Matt Kaplan with Ladenburg Thalmann.

[Analyst] (Ladenburg Thalmann): Oh, hi. This is Raymond in for Matt. Thanks for taking our questions. Congrats on getting the FDA on board with phase 2, renal transplant study. Very impressive. Just wanted to ask if perhaps, how your review of the phase 1b that you already started, did that change in light of the interactions for the phase 2 program?

Hi, This is Raymond in for Matt Thanks for taking our questions and congrats on getting the FTE onboard.

Very impressive.

Just wanted to ask with hubs.

How your view of the things <unk> already started to that change.

Interactions.

The phase two program.

David-Alexandre Gros: Thanks for the question, Raymond. Let me turn that over to Jeff.

Thanks for the question Raymond let.

Let me turn that over to <unk>.

Jeff.

Jeff Bornstein: Yeah. Thank you. If I'm understanding the question correctly, you're asking if our thinking around the 1B study has changed in light of getting the IND open for 2A. Is that right?

Okay.

Yes. Thank you so if I'm understanding the question correctly, you're asking if our thinking around the <unk> study has changed in light of.

Getting the IND open for Q&A is that does that right.

[Analyst] (Ladenburg Thalmann): Yeah. I was wondering if there's potential maybe the FDA is kind of, you know, evolving their thinking or perhaps, yeah.

Yeah, Yeah I was wondering if there is potentially maybe the fda's kind of.

Okay.

And we're thinking or perhaps.

Jeff Bornstein: Right. Okay. I can't speak for the FDA and what they're thinking, but for us it's nothing's changed. We are executing our ongoing trial. We think that trial is going to provide very meaningful data on the safety and efficacy in a pilot program for sure, but it's still very meaningful data on what tegoprubart can do in this population. As I mentioned on the call, our intent is to add a long-term extension trial to the program, not just to the phase 2a study, but it would also allow for those 1b patients have the opportunity to continue long term should they be so inclined and they're doing well. This will allow us to gain additional information over time on durability, on long-term outcomes in that sentinel cohort.

Right, Okay. So I can't speak for the FDA and what they're thinking but for nothing.

Nothing's changed we are executing our ongoing trial, we think that that trial is going to provide very meaningful data on the safety and efficacy in a pilot program for sure, but still a very meaningful data on what <unk> can do ease population and as I mentioned on the call.

Jeff Bornstein: As I mentioned on the call, our intent is to add a long-term extension trial to the program, not just to the phase 2a study, but it would also allow for those 1b patients have the opportunity to continue long term should they be so inclined and they're doing well. This will allow us to gain additional information over time on durability, on long-term outcomes in that sentinel cohort. We're very committed to that patient population and the participants in that trial. Nothing's changed for us with the new study also coming on in terms of with the existing study.

Our intent is to add.

A long term extension trial to the program not not just to the phase Iia study, but would also allow for those one patient had the opportunity to continue long term should they.

So in climate and Theyre doing well and this will allow us to gain additional information over time on durability on long term outcomes and that Sentinel cohort.

Jeff Bornstein: We're very committed to that patient population and the participants in that trial. Nothing's changed for us with the new study also coming on in terms of with the existing study.

We're very committed to that patient population.

The participants in that trial.

Nothing's changed for us with the with the New study also coming on in terms of what the existing study.

[Analyst] (Ladenburg Thalmann): Oh, appreciate that. I guess,

I appreciate that I guess.

David-Alexandre Gros: Yeah.

[Analyst] (Ladenburg Thalmann): Yeah.

David-Alexandre Gros: Just one addition, just to clarify. The 1B is ex US. While the phase 2 is where the IND was just cleared, the 1B will remain ex US.

One addition.

Just.

To clarify the one b is ex U S.

While the phase II will.

Is where the R&D was just cleared one b will remain ex U S.

[Analyst] (Ladenburg Thalmann): Oh, yeah.

David-Alexandre Gros: As you might recall, a year ago when we went ex US with the trial, the agency had asked us at that time to do a non-human primate study. What's changed has been really the completion of that non-human primate study, and then the agency clearing our IND.

Okay.

Recall, a year ago, when we had when we went ex U S with the trial.

As the agency had asked us at that time to do a nonhuman primate study so what's changed has been.

Really the completion of that non human primate study.

And then.

The agency clearing in R&D.

[Analyst] (Ladenburg Thalmann): Okay. Appreciate it. Yeah. I guess just one more question on the islet cell program. Congrats on making progress on preparing the US site. I was wondering if there's any lessons perhaps from the Canadian site experience that you might transfer over. Any insight would be helpful. Thanks.

Okay I appreciate it.

I guess just one more question on the island itself program Congrats on making progress on opening currently you guys cite I was wondering if there's any lesson, perhaps from the Canadian experience who might transfer over.

Any helpful any insight would be helpful. Thanks.

David-Alexandre Gros: Yes.

Yes.

Jeff Bornstein: Yeah, I mean, it's a very fair question to ask, but it's a difficult one to answer because there was multiple circumstances that contributed to that not going the way we had hoped in Canada. You know, it wasn't just one thing. There was definitely an impact of COVID. There was also some changing changing almost geopolitical landscape and how how islet cell was covered across Canada and changing kind of changing dynamic of who was referred to the site. There was a lot of different factors that contributed to it. It's a fair question to ask, but I unfortunately don't have a great answer for you. There's not one great takeaway that we had that we're going to say, "Aha.

Yes.

It's a very fair question to ask but it's a difficult one to answer because.

Multiple circumstances that contributed to that not going the way we had hoped in Canada and it wasn't just one thing that there was definitely an impact of Covid that was all.

Also some changing.

Changing almost geopolitical landscape and how.

I'll, let <unk> cover across Canada.

And changing at.

Patrick.

<unk> dynamic of who was referred to the site. So there was a lot of different factors that contributed to it.

Jeff Bornstein: There was a lot of different factors that contributed to it. It's a fair question to ask, but I unfortunately don't have a great answer for you. There's not one great takeaway that we had that we're going to say, "Aha. If we do this different, it's gonna go better." We do feel very confident in Dr. Witkowski and the team at the University of Chicago, and we do believe it's going to go different there. There isn't really one key takeaway that we've taken from that that we can apply going forward.

It's a fair question to ask but I. Unfortunately don't have a great answer for you. There is not there's not one great takeaway that we had we're going to say if.

Jeff Bornstein: If we do this different, it's gonna go better." We do feel very confident in Dr. Witkowski and the team at the University of Chicago, and we do believe it's going to go different there. There isn't really one key takeaway that we've taken from that that we can apply going forward.

If we do that's different that's going to go better we do feel very confident and Dr. Wikowsky and the team at University of Chicago, and we do believe it's going to go different there.

There isn't really one key takeaway we've taken from that that we can apply going forward.

[Analyst] (Ladenburg Thalmann): Fair enough. Thanks.

David-Alexandre Gros: The keys are what Jeff just mentioned. Here the focus is the site. Since islet cell transplants are considered an experimental procedure in the US, all of the patients that are going through the site are focused on getting an experimental procedure, so that allows for a slightly different conversation to be had with potential participants in the study. As well, it allows for some different coverage, and a different role in terms of our being able to support the program, versus a program where parts of the cost could have been covered by the Canadian authorities.

Alright fair enough <unk>, the key or what Jeff just mentioned so here the focus is the site.

Since <unk>.

Islet cell transplants.

<unk> considered experimental procedure in the U S. All of the patients that are going through the site are focused on getting an experimental procedure.

So that that allows for is slightly different.

Conversation to be had with potential participants in the study.

And as well it allows for some different coverage.

In a different role in terms of our being able to.

To support the program.

Versus a program where.

We are parts of the cost could have been covered.

The Canadian authorities.

[Analyst] (Ladenburg Thalmann): I see. Yeah, appreciate that color. Thanks.

Yes, I appreciate the color. Thanks.

Operator: Thank you. This concludes the question and answer session. I would like to refer to David-Alexandre Gros, our CEO, for any closing comments.

Thank you and this concludes our question and answer session and I would like to hand, the call <unk> CEO for any closing comments.

David-Alexandre Gros: All right. Thank you very much for your assistance, operator. Thank you all for joining us on today's call.

Alright.

Thank you very much for your assistance operator, and thank you all for joining us on today's call.

Operator: Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.

Q2 2022 Eledon Pharmaceuticals Inc Earnings Call

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