Good afternoon, ladies and gentlemen and welcome to Eledon Pharmaceuticals first quarter 2023 earnings conference call. At this time, all lines are listen-only mode. [Operator Instructions] This call is being recorded on Thursday, May 11, 2023. I would now like to turn the conference over to your host, Paul Little, CFO. Please go ahead.

Good afternoon, everyone, and thank you for joining Eledon's first quarter 2023 operating and financial results conference call. I am joined today on today's call by David-Alexandre Gros, Chief Executive Officer, and Steve Perrin, our President and Chief Scientific Officer. Jeff Bornstein, our Chief Medical Officer, is traveling today. Earlier today, Eledon issued a press release announcing financial results for the first quarter ended March 31, 2023. 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. 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 US Securities and Exchange Commission. Now it is my pleasure to pass the call to our CEO, Dr. David-Alexandre Gros. DA?

Thank you, Paul, and thank you all for joining us today. We began the year by announcing our primary organizational focus on our kidney transplantation program, and have since directed our resources and efforts to advance this program forward. 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. We believe there is a profound urgency for new treatment options to benefit patients receiving solid organ transplants and kidneys in particular. According to the United Network for Organ Sharing, there are now over 25,000 annual kidney transplants in the US, the most in history, and yet the standard of care first-line chronic immunosuppression for this growing market has not changed since the approval of tacrolimus in 1994. 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. This in turn should result in fewer patients requiring repeat transplants, thereby freeing more kidneys to be allocated to first time recipients and thus allowing more people to receive the kidneys that they need to live. At the end of March, we presented open label data from our ongoing Phase 1b trial, evaluating Tegoprubart in kidney transplantation at the World Congress of Nephrology. Our initial three participants did not show any evidence of acute rejection at measured time points, which is important since most rejection in the first year occurs within the first 90 days post transplant. In addition, we observed strong graft function in our participants with mean eGFRs above 70 at measured time points as…

Thank you, DA. I'd like to begin by touching upon the opportunity we see in kidney transplantation and why we made the decision to focus our resources on the development of Tegoprubart for this indication. Kidney transplantation is a growing space which has had limited innovation in decades. The National Kidney Foundation estimates that 660,000 people live with kidney failure in the United States. And out of those are over 100,000 people on the kidney transplant waiting list with about 5,000 individuals dying annually while waiting for a transplant. Since the average deceased donor transplanted kidney only functions for an average of 10 to 12 years, and the mean age of transplantation is 50 years old, most patients will require multiple kidney transplants if they are to live a normal lifespan. Therefore, the need has never been greater to pursue a new treatment option that can prolong the functional life of a transplanted kidney. That is our goal. And we believe this can be achieved with Tegoprubart, allowing transplanted kidneys to last the duration of recipients lives and thereby freeing a precious kidney so that a greater percentage of patients on the waiting list can receive a kidney. As DA mentioned, we reported open-label data from our ongoing Phase 1b kidney transplant study at the World Congress of Nephrology in March. At the time of data submission, three patients have been enrolled in the trial, which has sites enrolling in Canada, Australia and the UK. To evaluate signals of clinical efficacy, we reported the estimated glomerular filtration rate, or eGFR, of each patient at specified time points. From large retrospective studies conducted in transplant recipients taking CNIs, we know that a 50th percentile eGFR falls around 50 during the 1st year post transplant. 12 month eGFR has been shown to…

Thank you, Steve. 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. Research and development expenses were $8.1 million for the three months ended March 31, 2023, compared to $6.6 million for the comparable period in 2022, an increase of $1.5 million. The increase is primarily due to higher clinical development expenses, primarily with external CROs of $2.1 million and an increase in personnel costs due to increased headcount. The increase was partially offset by decreases in stock-based compensation, manufacturing, and consulting expenses. 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. The decrease was primarily result -- primarily related to the lower stock-based compensation costs. Earlier this month, we announced the entry into a definitive securities purchase agreement with select healthcare investors that will provide up to $185 million in gross proceeds through a private placement. The purchase agreement included an initial upfront financing of $35 million, an additional aggregate financing up to $105 million, subject to achieving clinical development milestones, volume, weighted share price levels, and trading volume conditions. Plus up to $45 million upon the full exercise of warrants being issued in connection with the agreement. The financing was led by BVF Partners and Armistice Capital and includes participation from new and existing investors, including the global pharmaceutical company, Sanofi. Eledon ended the first quarter with approximately $46.5 million in cash and cash equivalents. With that financial update, I'll turn the call back over to DA.

Thanks, Paul. 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. We are highly encouraged by the data generated to date in our ongoing Phase 1b study and look forward to both its continued enrollment and to providing a clinical update later in the year. 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. Operator, please begin the Q&A session.

Thank you. [Operator Instructions] Pete Stavropoulos, Cantor Fitzgerald.

Hi, DA, Steven, and Paul. Want to congratulate you on your successful financing and are happy to see that the Tego kidney transplant program is moving forward. So, you know, one of your investors stood out at me when I saw the press release for the financing, which was Sanofi. It's a well-established -- it has a well-established kidney transplant franchise, so well versed in the space. Can you provide any color on those interactions? And what do you think drew them -- drew this company to invest in this molecule and program? Do you think was the totality of the data generated with Tego to date across all programs? Or was it kidney specific data?

Hey, Pete. Thanks for the question. In terms of Sanofi, we obviously appreciate having them as a new investor. As you mentioned, they know the space quite well. They've also had said in the past that in terms of the way they viewed their interactions or their development in the space, they were not looking at kidney transplantation. I think they looked at us and saw a good investment opportunity. This was an investment that came though in the same way as other investors. So Sanofi did not get any type of rights beyond -- or in any way different from what other investors received in this financing.

All right. Thank you. So I have a couple of questions on the BESTOW study. The data presented for Tego at the Kidney Transplantation World Congress of Nephrology, there were there was one patient who had BK viremia. Can you sort of touch on how common BK viremia is in kidney transplant? And how is it going to be handled in the BESTOW study? Will it be up to the investigator to withdraw the patient from the study? Or will there be some type of protocol in place?

Thanks for the question, Pete. Steve, I'll turn that over to you.

Yes, BK viremia, Pete, is -- it's a great question. BK viremia is pretty common. It's common across all poly pharmacy that is associated with the prevention of transplant rejection that occurs in 10% to 20% of studies. And it does vary from site to site, country to country, and it does vary regiment to regiment. The standard practice for dealing with the viral load with BK viremia is to wean people off the immunosuppressant drugs that are required to prevent rejection, and that's done at the discretion of the PI depending upon viral load. And then there's this balance between letting the immune system of the transplanted individual fight back the viral load while still trying to protect the organ from rejection. And obviously, that is up to the investigator on a site-by-site basis on how they want to manage that.

Okay. I mean, I don't know if you've disclosed, but is there opportunity to sort of wean off of Tego and then sort of put it back on as time progresses?

So being an antibody, typically the administration, as you know, is every three weeks. And so if somebody's viral load creeps up shortly after dosing, the investigator has a period of time where they could tried to manage other immunosuppressants to see if they can manage viral load and get it back down prior to the next infusion. There is some flexibility on if you wanted to delay the next infusion of Tegoprubart a little bit. 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. Again, we'd be in close dialogue with PIs if that's the route that they chose to take and we would give them guidance based on what we know from our preclinical and clinical data to date on how to manage that.

Great. Thank you for that. Another question again on the BESTOW study. One of the goals will be to reduce steroid use. And there will be steroid tapering from my understanding until they're completely removed from each of the patients' treatment regimens. Can you just talk a bit about like the clinical benefit? It may be still on these patients, tapering them off? And how do you plan to capture that benefit?

DA, do you want me to take that one?

Sure.

The steroids, Pete, as you point out -- another great question is the primary difference between our Phase 1b study and the Phase 2 BESTOW study, where in the BESTOW study, they will start weaning off participants off steroids fairly quickly after transplant and they will be off steroids by six months. This is not an uncommon practice. Many sites globally do a complete steroid taper. And there is variability among sites that do that. The biggest thing that's beneficial here to patients is, again, the side effects of steroids can be significant. And so getting patients off as many of the immunosuppressant drugs in a cocktail is critically important for managing side effects. And so we think it's a potentially great upside. But we feel that we're tickled [indiscernible]. We can completely wean people off of steroids in a fairly rapid manner by six months.

[Multiple speakers] People don't like to be on steroids -- it's DA. People don't like to be on steroids long term. They've got it just impacts in terms of blood sugar control, moods, ability to sleep, potential hair loss. 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.

In terms of the clinical study, any secondary or exploratory endpoints that you're going to use to sort of capture that benefit?

[Multiple speakers] I'm sorry.

No, no, go. You can go.

I don't think there, Pete, there's any exploratory endpoints that specifically deal with the tapering of steroids. But obviously to be captured as part of the safety profile of Tego much like in our other studies.

Okay. Thank you very much.

We're going to look at removing steroids from both arms. So it would be comparative. But in terms of the steroid specific side effects, one would see the benefits if one compared the data at historicals.

All right. Thank you very much. And again, congratulations on the financing and all the progress.

Thank you, Pete.

Thomas Smith, SVB Securities.

Hey, guys, good afternoon. Thanks for taking the questions and congrats on all the progress. A couple of questions on our end. I guess first on the Phase 1b study, you mentioned that you've enrolled six patients to date and you're targeting a medical meeting later this year for an update. So, if you can elaborate on some of the venues you're considering and just walk through sort of your expectations in terms of how many patients an amount of follow-up you think you could have by then?

Thanks, Tom. It's DA. So we'll look for a medical meeting towards the end of the year. There are a number of kidney meetings for this including Kidney Week, where we might be able to present. Since we already have six patients as we just mentioned. Even without counting potential new patients that come into the study, that would mean that all of the patients would have over 90 days -- would most probably have over 90 days on drug by that point. So would go from somewhere in the 90 day timeframe all the way out to a year or so.

Okay. Got it. That makes sense. And then, maybe just following up on the Sanofi investment. I understand they are pursuing solid organ transplant at this point for their CD40 ligand for [indiscernible]. But maybe if you could just remind us of the differences between Tego and [indiscernible]. And then just on thinking a little bit bigger picture, wondering if you could comment on sort of the broader strategic interest in the space and how you're thinking about partnership or other business development opportunities at this point?

Sure. So the two molecules or anti -- both ourselves and Sanofi have an anti-CD40 ligand. We're using a full antibody approach. And so, the two molecules are probably -- if you looked at the broader competitive landscape, the two that are the most similar. The difference has really been around strategy and where we've each -- each company has chosen to focus. We've now chosen to focus on transplant. Sanofi's focus has been on larger population indications, including [indiscernible]. They're running trials in MS, and they've discussed the rheumatoid arthritis before. So that is the difference in terms of the approach that we're taking. [Indiscernible]

Yes, that's helpful. I was just wondering if you could comment on sort of the broader strategic interest in the space and how you're thinking about business development and partnership opportunities at this point?

Yes. So in terms of broad interest in the space, I think there are a lot of companies that are interested in the broader immunology space. It's become one of -- a key area of focus for both smaller biotechs as well as large pharma. From our perspective today in terms of business development, we are not looking to in-license. That wasn't one of the reasons why we did the deal. And we now have the capital we need if we hit our milestones to be able to take this drug and develop it all the way through to getting a Phase 2 data and beyond. So that's very much what we are going to be focused on, which is executing our trials and continuing to generate data with Tegoprubart.

Got it. That makes sense to me. All right, guys. I appreciate you taking the questions and congrats again on the progress.

Thank you. Appreciate it, Tom.

Thank you, Tom.

Rami Katkhuda, LifeSci Capital.

Thanks for taking my questions as well. And congrats on the update. A couple of quick ones from me. I guess first up, are you guys using the iBox scoring system in the BESTOW study?

Yes, that's being evaluated as an exploratory endpoint. [multiple speakers] Great question, Rami. 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. So a great question.

And Rami, maybe just to add to what Steve said, we're doing it as part of our collaboration with CareDx. So if you remember, we announced collaboration with CareDx, and that covers a number of biomarkers and algorithms including iBox.

Got it. Makes sense. And then going up a previous question, with recent regulatory successes in the ALS field, excuse me, can you touch upon potential routes to make [indiscernible] continued development of Tego in that indication?

So right now, this financing is going to allow us to advance Tegoprubart in transplantation. And that's what we are primarily focusing on. We'll continue to look for other ways to potentially finance Tegoprubart in ALS as we've said before. And we believe in order to advance Tegoprubart in ALS, what we would like to do is it is a trial that would be well designed and does have a -- the best possible chance of success to do a smaller trial, potentially one that would require less money. We don't think would help fundamentally answer the question of whether Tegoprubart would work in ALS, and as such, wouldn't be the best solution for patients and for the field. So we're focused on transplant. We'll continue to look at ways to advance Tegoprubart in in ALS. And then if we do so, we do it in a way to have a trial that would be substantially set to truly be able to answer the question of how well Tegoprubart is working in that indication.

Got it. Thanks so much.

Vernon Bernardino, H.C. Wainwright.

Hi, DA, Steve, and Paul. Good afternoon and thanks for taking my questions. Congrats on bolstering the balance sheet. And I appreciate the presentation on the kidney transplant. This question is less more to do with that data -- and apologize for the music. Hopefully you can hear me well enough. And perhaps what to do with Tegoprubart in IgAN. Given what you perhaps see as side effects, biomarkers that are looked at, and perhaps endpoints you're considering for again, less severe with a kidney transplant, but perhaps a future study with -- in IgAN. Is there anything that is informing you that targeting anti-CD40 ligand as a strategy to prehaps replace calcineurin inhibitors is informing you that targeting anti-CD40 ligand is working? Because as you know, with the calcineurin inhibitors, you've seen that as dose goes up, so does side effects, so does efficacy. Except for perhaps a bit of an exception that we've seen but not performed. 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. So you don't have a concrete idea about how to answer this question. Just wondering if there's something you're seeing now that's perhaps informing you of future study and whether targeting anti-CD40 ligand is churning out as you expect? Sorry for the long preamble.

Vernon, thank you for the question. Steve, I'll turn that over to you to talk about what we're seeing or what we've seen in terms of biomarkers as well as how you interpret the data that we've generated to date with regards to Tegopurbart's efficacy.

Sure, DA. Great question, Vernon. Thank you for that question. We've actually gleaned an amazing amount of data from very diverse indications to date in a very short period of time as you know. 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. That translated into functional decreases and over 20 pro-inflammatory markers that sit downstream of co-stimulatory signaling. So again, very good functional data showing that Tegoprubart modulated the immune system in that study. And it did so in a very rapid way after the first infusion, which was quite exciting. Globally across all of our indications, the safety profile of Tego continues to look very exciting and very encouraging. We haven't seen any serious adverse events in any of our studies. 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. 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.

Do you plan to present any outcome, even if it's preclinical data, that continues to validate the approach?

I mean in the preclinical side, we have multiple collaborations going on both with allograft transplant experiments as well as in the xeno transplant space. As we've mentioned, we have a collaboration with eGenesis that's ongoing. So we anticipate that as we continue to execute on those primate studies, both on allograft and xenograft that we will present them at some point at scientific conferences.

Perfect. And I'm glad to see we have a bolstered balance sheet and looking forward to more data. Thanks again for taking my questions.

Thanks, Vernon.

[Operator Instructions] Matt Kaplan, Ladenburg Thalmann.

Well, hi, this is Raymond in for Matt. Thanks for taking my question and congrats on all the progress. I guess the question I was thinking -- I was reading -- I read this recent New York Times article about transplantation, very compelling. And I was wondering, how are doctors and patients responding to the initial data in your renal transplantation program? Is that potentially building more awareness for your Phase 2 trial? And I have another question.

Thank you. That is a wonderful opinion piece that was published in the New York Times, and I encourage really everyone on the call if you haven't had a chance to read it to do so. Steve, let me turn it over to you in terms of awareness, the need, and the receptivity that physicians that you've been talking to have had to our data.

Yes, sure. Thanks, DA. And a great question, I agree. The receptivity has been absolutely amazing. I mean, there's a long history, as we know, of blocking this pathway going back 25 to 30 years with many different antibodies in preclinical models in particular. But the field was set back in the early 2000s with the first-generation antibodies. And yet to this day, blocking this pathway and [indiscernible] blocking CD40 ligand in particular has been the most potent way to prevent transplant rejection. It was also a very, very potent strategy to ameliorate autoimmune diseases in multiple different models. 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. But folks have been very excited because of the opportunity to reengage this pathway after so many years.

Yes, that's great. Thanks for the -- all that color. I guess just one other question. It might be too early to say, but the kind of impressive data you had so far and thinking about the BESTOW trial, the magnitude and duration of any potential [EDR] benefit over [indiscernible] might potentially dictate the path forward now clinically or regulatory?

Yes. So we obviously would want to show a -- we're looking at eGFR, and this is a superiority study. So we're going to want to see is statistically superior Delta in terms of eGFR versus standard of care. And the larger that that delta the better. I would note that even small deltas and eGFR can make a difference clinically. So for example, we know that as early as six months, if you have 10 point delta and eGFR means an 11% delta in the chance of a patient being -- of a post transplant patient being hospitalized. Similarly, the lower the eGFR, the more likely the patients are to be hospitalized multiple times. And finally of course, eGFR is associated with the risk of graft failure. So the lower the eGFR the higher the risk of that kidney being lost. And that graph, that increase is almost exponential, pretty much exponential. One to one has an eGFR that goes below 50 or 55, which is the mean eGFR in post -- in the year post transplant. So if we would be able to move the needle in those patients by even only 10 points, that would be very meaningful since we're looking at an exponential increase in terms of risk. Steve?

I appreciate it.

I was going to see if Steve wanted to add anything.

No. Yes, I agree. I mean, even small differences in eGFR based on very large retrospective studies can really impact our long-term graft function and survival. So, even smaller differences will be very, very important.

Thanks for that. Congrats on all the progress.

Thank you.

And there are no further questions at this time. I will turn the call back over to Mr. Gros for closing remarks.

Thank you for your assistance, operator. And thank you all for joining us today on this call. Have a great evening.

Ladies and gentlemen, this concludes your conference call for today. We thank you for joining, and you may now disconnect your lines.