Xencor Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 7, 2023

There are 17 speakers on the call.

Operator

Good afternoon, and

Speaker 1

thank you for standing by. Welcome to Sencore's 3rd Quarter 2023 Conference Call. Please be advised that this call is going to be recorded at the company's request. Now, I would like to turn the call over to your speaker today, Charles Liles, Head of Corporate Communications and Investor Relations. Go ahead, Charles.

Speaker 1

The end of the call.

Speaker 2

Thank you, and good afternoon. Earlier today, we issued a press release, which outlines the topics we plan to discuss today. The It's available on www.sencor.com. Providing comments on the call is Basil Dahyad, President and Chief Executive Officer and Nancy Valente, the Investor Relations Conference Call. Afterwards, we will open up the call for your questions and we'll be joined by John Des Jarlais, Chief Scientific Officer and John Cush, Chief Financial Officer.

Speaker 2

The end of the call. Before we begin, I would like to remind you that during the course of this conference call, Xencor management may make forward looking statements, including statements regarding the company's future financial and operating results, the Investor Relations, plans and objectives of management, future operations, the company's partnering efforts, capital requirements, future product offerings and research and development programs. The end of the call. These forward looking statements are not historical facts, but rather are based on our current expectations and beliefs and are based on information currently available to us. The the The outcome of the events described in these forward looking statements are subject to unknown risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated by these forward looking statements, the end of the call, including but not limited to those factors contained in the Risk Factors section of our most recently filed Annual Report on Form 10 ks and Quarterly Report on Form 10 Q.

Speaker 2

With that, I'll pass the call over to Bassil.

Speaker 3

The Thanks, Charles. At Xencor, we're advancing a broad internal development portfolio of engineered antibody based therapeutics in oncology and autoimmune disease at the that we've built with our array of modular continually advancing XmAb protein engineering tools. We're taking multiple simultaneous shots on goal in the clinic and we use emerging data from clinical studies the end of the call to guide which programs we advance, which we terminate and which we partner. A stringent review of this data and the status of competitors allows us to the We're now focusing on the tremendous opportunity for our targeted T cell engager bispecifics in solid the end of the call. The class of CD3 T cell engagers has recently shown great potential for bringing tumor targeted T cell therapy to bear against solid tumors, the A long standing challenge for both antibody and cell therapy modalities.

Speaker 3

At the recent ESMO conference, our partner Amgen presented highly encouraging interim results for a Phase 1 study the end of the call. Zalaritamig in patients with advanced prostate cancer. Zalaritamig is an XmAb2 +1 CD3 T cell engager targeting STEEP-one. The We created a 2+1 bispecific to address a challenging target with limited extracellular exposure. Amgen reported that during dose expansion and optimization, the end

Speaker 4

of the quarter.

Speaker 5

The 41% resist response rate has been seen in high dose

Speaker 3

cohorts and that preliminary durability while early is encouraging. The We look forward to further updates and progress with Amgen's plans for additional studies in earlier lines of treatment. The enhanced customization afforded by the 2 plus one format enables antibodies the more avidly to and selectively kill those tumor cells with higher antigen density, potentially sparing normal cells. The as a consequence opens the door to a wider range of solid tumor targets than were previously accessible to T cell engagers. The And leading our own internal pipeline for this modality in Phase 1 is XmAb-eight nineteen targeting E and P3 in renal cell carcinoma, the followed by XmAb-five forty one targeting CLALON-six in ovarian cancer and other tumors.

Speaker 3

Our second set of tumor targeted T cell engagers are co stimulatory bio the CX-twenty eight on T cells for targeted immune activation. CD28 co stimulation has some promise for enhancing anti tumor immune activity the and Xencor CD28 platform has been engineered to expand the therapeutic window of CoStim activation by using reduced potency CD28 binding. The RCD28 bispecific XmAb-eight zero eight, which targets the broadly expressed tumor antigen C7 H3 is in a Phase 1 study in advanced solid tumors. The In addition, this quarter, our partner Janssen, now J and J Innovative Medicine, has advanced both of our CD28 collaborative programs, submitting an IND for the prostate cancer candidate and a CTA in Europe for the B cell malignancy mark. We anticipate further expanding our pipeline of T cell engaging bispecifics in future.

Speaker 3

The end of the call. As part of our efforts to provide sufficient resources to advance these programs, today we're announcing that we have added $215,000,000 in cash to our balance sheet the from selling a portion of our royalty interests in Ultomiris and Mongevy to OMERS, a Canadian pension fund. These two products were created with the Inchor's modular XmAb Fc domains and technologies, which are the foundation that enables our diversified approach to building value. Our platform has been fundamental to the creation the 3xnab based medicines marketed by partners, which generated royalty income that further drives innovations in our protein engineering and supports the advancement of our internal pipeline. The end of the call.

Speaker 5

We believe that the strengthened financial position from

Speaker 3

this deal offers us additional flexibility to execute on our internal clinical development programs the greatest potential for success and the deal structure lets us retain potential economic upside from the sales performance of Ultomiris and MongeVie. The We've also made changes to our pipeline. We're terminating development of our Phase 1 PD-onex ICOS program XmAb-one hundred and four at our closing gynecologic tumor cohorts that are ongoing vedalumab Phase 2 monotherapy study. For XmAb-one hundred and four efficacy data and expansion cohorts in MSS colorectal cancer the end of the call. And for vedalumab and gyn tumors, we see a rapidly changed competitive environment.

Speaker 3

We will keep the reporting patients currently enrolled in the studies, including by continuing to provide study drug. Now on to fvalbripendikin alpha, formerly XmAb306. The that's our co development program with Genentech, where we have decided to opt out of our cost sharing arrangement and P and L split, because as the clinical trial reach and the time of the program continues to expand, we've had to prioritize it against other highly promising programs. We're still very supportive of the program and Genentech's development plans. The end of the call.

Speaker 3

We elected, per the contract, to shift to a milestone royalty structure. We'll provide additional detail when the specifics are finalized, the end of the call, but we would anticipate terms commensurate with a license of an asset at this stage of development. As a result of the royalty deal, along with these program reductions and a continuing focus time on reducing costs. We are guiding that we have cash runway into 2027. Now for a review on our wholly owned clinical portfolio, I'll turn it over to Nancy Valente, our Chief Development Officer.

Operator

Thanks, Basil. First, fudalimumab, our T cell selective checkpoint inhibitor at the end of the call, we are committed to the following questions. We are committed to the the end of the call. We will now focus our attention on prostate cancer, the end of the call, both in this monotherapy study and in the study in combination with standard of care therapies. And we're on track to initiate our the first line non small cell lung cancer study by year end.

Operator

In this study, we have a design that gives us an early look at safety and efficacy the end of the call from 2 dose level cohorts in combination with chemotherapy, and this is prior to the second part of the study that randomizes against standard of care pembrolizumab in the chemo. Next, with our other dual checkpoint inhibitor targeting ICOS and PD-one, XmAb-one hundred and four, the end of the call. The signs of activity in microsatellite stable colorectal cancer were observed early on, expansion cohorts did not meet the pre specified the time of the call, and we are stopping program development. Before moving to earlier stage programs, the One note on pamodamab, which we licensed to J and J Innovative Medicine in 2021, we are wrapping up our internal clinical work, the end of the call, and we would anticipate further development activities will be done by Janssen. Now among our internally developed cytokines, the end of the call.

Operator

Our Treg biased IL-two Fc being developed in autoimmune disease, XmAb-five sixty four, the continues to enroll patients with either atopic dermatitis or psoriasis in multiple dose escalation the end of the call. And our potency modulated IL-twelve FC in advanced solid tumors began dosing patients the Phase 1 dose escalation study in the Q3. Finally, our clinical XmAb 2 +1 bispecifics, the end of the call, which Basil introduced. Both XmAb-eight nineteen and XmAb-eight respectively, our ENPP3xCD3 and B7H3xCD28 antibodies continue in dose escalation. The end of the call.

Operator

We and the investigators remain enthusiastic about the potential of these programs. We are also on track later this year to submit an IND the for a 3rd internal 2 plus 1 bispecific, XmAb-five forty one, a claudin-six targeted CD3 engager the end

Speaker 4

of the call to be developed in ovarian cancer and other solid tumor types.

Operator

Since the claudins are so similar in structure, the end of the call. Selecting specifically for CLAUDE6, especially over CLAUDE9, 3 and 4 is critical. The The 2 plus 1 format and our protein engineering really provides for CLAWDN6 selectivity. And in our preclinical work, we see beautiful the end of the call, we will be conducting a call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call to initiate the call. The end of the call.

Operator

We're really excited about getting this molecule into the clinic, continued progress with 819 the next wave of 808 and expanding more into solid tumors with more T cell engagers. The end of the call. With that, I'll pass the line one more item before moving on to Q and A.

Speaker 3

Thanks, Nancy. First, I'll say please refer to our press release for financial results. The end of the call. On a related note, for 23 years, all financial functions at Xencor have been led by one person, John Cush, who at the It's possible to encapsulate so briefly how much we have relied on John for over 2 decades, pulling us out of some truly dire situations over those years. The end of the call.

Speaker 3

As we announced last month, John plans to retire early next year in March and we thank him for his critical role in pursuit of creating and advancing new medicines for patients. The end of the call.

Speaker 1

Thank you. At this time, we will conduct a question and answer session. At the

Speaker 5

the end of the call.

Speaker 1

Our first question comes from the line of Edward Tenthoff from Piper Sandler. The end of the call.

Speaker 6

Great. Thanks. Can you hear me okay?

Speaker 3

You're a little static, but we'll try.

Speaker 5

The

Speaker 6

end of the call. Okay. If I have to, I'll try to pick it up the pick up the receiver. So, first, John, wishing you all the best in retirement. The I'm sure you're going to miss all the craziness with DAS.

Speaker 6

So it's been a ton of fun working with you. The I appreciate all the color and congrats on the Omer's deal. I wanted to kind of get a little bit more of a sense with respect to Plamo the end of the call. In terms of your comments about stopping internal development, does this change the The ongoing studies at all, does this take your ownership at all? Just want to get a little bit more color what that means.

Speaker 6

Thank you.

Speaker 3

The Sure, Ted. Sorry if that came off a little bit confusing. No, this is a no change whatsoever from the plan we've had with Janssen for the last 2 years. The plan was always that we would finish the ongoing Phase 1 study when we the Completed the work with our subcutaneous formulation and then they would just pick up all clinical development activities themselves. The deal structure hasn't changed.

Speaker 3

It's just whose hands are doing the work. That was more of an update on we've essentially finished the subcu Phase 1, we're wrapping that up the Janssen's picking up therapy. So there's no change. Sorry for the confusion.

Speaker 6

No worries at all. And can you just remind us what studies are ongoing for that one?

Speaker 3

The That's the Phase 1 where we're wrapping up the subcutaneous dose escalation and expansion. And then we anticipate the that the molecule would be studied in combination with the lead B cell and malignancy CD28 program that they just the CTA for where they're planning on studying that with multiple agents both internal to Janssen or J and J Innovation and us. So that's always been the game plan and we're anticipating that next step soon we hope.

Speaker 6

Awesome. Thanks so much.

Speaker 1

The the end of the call. Our next question comes from the line of Dane Leone from RJS.

Speaker 5

The end of the call.

Speaker 7

Thank you for taking the questions and congrats on the progress. And John, wish you the best in retirement. It's been a the pleasure working with you over the years. Maybe we could expand a little bit on the design of the the frontline non small cell lung cancer study with nadelumab. It sounds pretty interesting.

Speaker 7

I think probably the Two questions for us on the study design. Firstly, how much of the dose finding do you already have an idea about at the end of the call, given the ongoing prostate and other solid tumor studies that could be informative. 2, what would be the the actual patient population with regards to the mutational burden, PD-one status, cut points, etcetera that you would envision and presumably this would be an ex U. S. Study the end of the call.

Speaker 3

I'll let Nancy pick up the ball on that one.

Operator

Yes. The So the study design, is the Phase 1b2. We're going to study 2 different cohorts of the 2 different doses of udelumab in 2 cohorts and then make a determination of those dose or even a dose between that to take into combination with standard of care chemotherapy for non small cell, non squamous. The end of the call. We do have a lot of information about the dose from our prior Phase 1 dose escalation from, as you said, our studies in gynecologic malignancies, prostate cancer.

Operator

And so we use that to pick these doses the To look at, the other part of the question was?

Speaker 3

The patient population like PD L1 status.

Operator

Yes. The PD L1 status is 0 to 49. And yes, at the So it's 0 to 49 first line standard of care treatment. The We're going to we're opening the study in the United States and also ex U. S.

Operator

As well. The So we do plan to enroll patients in the United States.

Speaker 5

The end of the call.

Speaker 7

Do you have a general timeline at this point of when you would have initial outcomes the base results that would be informative of potential next steps or just even the correct dose.

Operator

The Yes. So we're in the process of initiating this study right now. It's really hard to tell right now the When we'd have the Part 1 and the Part 2. Part 1 obviously would come first. We'd be the end of the call.

Speaker 5

We're able to look at that

Operator

data, share that data externally. It's very hard to predict when that would happen. The end of the call. And then once we see that, we'll move on to the randomized Phase 2 portion against pembro the end of the call.

Speaker 4

Great. Thank you.

Speaker 1

Thank you. One moment for our next question. The

Speaker 5

end of the call.

Speaker 1

Our next question comes from the line of Esther DeRout from BMO Capital Markets. Your line is now open.

Speaker 8

Great. Thanks for taking the questions. I guess maybe the the end of the call. First one,

Speaker 5

just maybe for modeling purposes, if you

Speaker 8

can sort of maybe help us understand to the extent that you can sort of the residual royalties and or milestones the that you would receive for on JUVIAULTOMERIS just as how we should think about how to model any residual sort of upside here at the end of the call. And then secondly, just curious on sort of the focus on the 2 +1. The end of the call. We saw some encouraging data from AMG 509 at ESMO. Just wondering if you're seeing any other kind of interesting clinical signals so far at the end of the year.

Speaker 8

From your other 2 plus 1 molecules in the clinic, I know they're early, but just wondering if maybe You're starting to see sort of evolution here of a profile that you really like that you're sort of doubling down if you will on sort of solid tumors. Thank you.

Speaker 3

The Thanks, Etzer. I'll answer the second question first before I turn it over to John Cush on the royalty deal. The So, we're not disclosing any data around any of our ongoing programs or for that matter some of our partners still have ongoing 2 plus 1 programs like Astellas is moving forward with their cloud in 18, too. So we'll give data later. I will say that we and our investigators remain enthused the end of the call.

Speaker 3

And there is a really great unmet need for certainly an ENP renal cell carcinoma, highly cytotoxic antibody. At the end of the call. And so we're pedal to the metal, but we're not going to share any details about the trial just yet. On the royalty deal and some of the residuals, John, you want to go the

Speaker 9

Yes, sure. There's 2 separate transactions. 1 is the Ultomiris deal, which there's caps from 26 at the end of the Q1 of 2019, the first $35,000,000 Omeris gets, we get the excess over that. Beginning 'twenty nine, the first $12,000,000 goes at the Investor Relations website. There's also a potential milestone of $12,000,000 for sales, which we could earn for the U.

Speaker 9

S. And U. S. Sales from July 1, 23 to June 30, 24. The second transaction is the Montjuvie, the end of the call, which we received $22,500,000 upfront.

Speaker 9

Ameris gets 130 percent of that upfront payment or $29,500,000 at any excess we receive the residuals.

Speaker 8

Got it. Great. Thank you.

Speaker 5

The the end of the call.

Speaker 1

Our next question comes from the line of Charles Hsu from Guggenheim Securities. Your line is now open.

Speaker 10

Hey, guys. This is Rosie on for Charles. Thanks for taking our questions and congrats on all the progress. So the I have two questions regarding vedalumab. So in the frontline non small small lung cancer setting, could you maybe comment on how the udalumab is differentiated from the competitor bispecific.

Speaker 10

And then for the monotherapy setting, you had provided guidance to data for the same time in early 2024. Could you maybe talk a little bit regarding how you're setting expectations for that data readout?

Speaker 3

The end of the call.

Speaker 5

So I'll take the second

Speaker 3

one first and then Nancy, you want to take one on the frontline lung. So we're going to have a greater end that we're going to report. The We've reported relatively small numbers of patients out of the trial so far and we haven't reported any out of the monotherapy trial. So we're just going to really it's about increasing the numbers, so we can zero people in on where we think their strongest potential is the of the various cohorts in our combo study as well as in the monotherapy. And in terms of setting expectations, I think the landscape the shifting a lot in prostate cancer, I think we're certainly very aware of the zalaritimig data the from Amgen in a similar line of therapy showing the 41% OR, obviously very excited because we made the same time, but also mindful of that.

Speaker 3

And so I think we're looking at a bar that might be shifting a little bit. The And just this is about us determining where we fall relative to that bar with a higher number of patients. So I don't think we can offer too much more than that.

Operator

The And I think you asked about differentiating from our competitor competitors. The Yes. And so, John can also, I guess, chime in here, but vedelimab was designed the Investor Day, specifically and optimized to have reduced potency in some ways to be very effective, the but also to be very tolerable, as far as toxicity goes. The idea is that it would bind the dually bind T cells that have both expressed and these are in the tumor itself versus the circulation. The end of the call.

Operator

The data so far, when we compared our data to some of the competitors. It's a little bit hard, but when we look at when we try to look at Phase 1 or dose escalation compared to dose the end of the call. What we saw was we have very heavily pretreated patients that are checkpoint failed or experienced at the end of the call, and our competitors often have checkpoint IU patients. So it's very hard to do that apples to apples comparison. But even with that, by doing so, when we

Speaker 5

looked at the efficacy across products

Operator

and the safety, at the safety, we thought we had something that was probably similar and the end of the call. Likely to be less toxic as we moved it into earlier settings. So that's what the That's how, I would summarize the differentiation.

Speaker 10

Great. Thank you. And maybe just a follow-up on the CABP-five sixty four. Is there can you provide any color on how enrollment has progressed for the multiple ascending dose study?

Speaker 3

The The enrollment is really not it's a relatively small study. The number of patients relatively small enrollment the is not really the driver of the timeline at all. It's the escalation, safety windows that you have to wait through at the end of the call to go to the next dose level in the next cohort in the multiple ascending dose.

Speaker 10

All right. Thank you.

Speaker 1

The

Speaker 5

the end of the call.

Speaker 1

Our next question comes from the line of Gregory Renza from RBC Capital Markets. The end of

Speaker 5

the call.

Speaker 11

Hi. Thank you so much for taking our questions. This is Scott on for Greg. I have a question on the T cell engager. The I'm just curious if you can talk about the learning from cell arrhythmics data, particularly on the adverse events.

Speaker 11

I'm just curious if you think the The adverse event is within the acceptable and expected level for the class. And if that's the Something that you can do to mitigate that for your study? Thank you.

Speaker 3

Yes, I'll take that. I think it's the adverse events they saw I think are the We're deemed certainly by Amgen quite within the range of acceptable. They're aggressively expanding the program. I think the One of the things they're going to have to work on and I think they're well positioned is educating a new community of oncologists about the T cell engagers and cytokine release syndrome. This is the prostate cancer community.

Speaker 3

They're not used to it. They're not used to IRAEs because they're not used to checkpoints, but the I think they'll get there. I think we've seen these kinds of adoption of highly active agents, work its way through the oncology community when we saw ADC start to emerge about 4 or 5 years ago more broadly. So I think it's well within the range. We saw the learnings we saw from them were really nothing new.

Speaker 3

It's you use priming doses and step ups. You have to be thoughtful about optimizing them. And one of the things they did is they adopted somewhat more aggressive the pre medication routine before the infusions while they're stepping up the doses when they're jumping from a prior dose being lower to the next one higher the And that's just the usual pre medication people have done with Rituxan for decades, a Tylenol, a Benadryl the and then corticosteroid. They just intensified that somewhat and it had a big impact. So those are the kinds of things we're considering the And being very aware of.

Speaker 3

Anything to add there, Nancy?

Operator

No. I agree. I think it's this class of drugs the cytokine release is expected. And I think as people get more comfortable managing it, the end of the call. It won't be a deal breaker, that the efficacy is really strong.

Operator

And you have to remember, the These were patients that were multiply pretreated. They had a median of 4 prior therapies. Yes, the So to see a response rate like they saw, 41%, it's pretty amazing, for these kind of patients. And the So it's great to see this and other CD3s moving forward and showing this kind of activity the Because it shows that T cell engaging bispecifics are going to have a role in the treatment of solid tumors,

Speaker 5

the the end of the call.

Speaker 1

Thank you. One moment for our next question.

Speaker 5

The end of the

Speaker 1

call. Our next question comes from the line of Alex Stranahan from Bank of America. The end of

Speaker 4

the call. Hey, guys. Thanks for taking our questions. Just a couple from us. One more on AMG 509.

Speaker 4

The We've heard some differences in opinion on PSA50 reductions as a good surrogate for response, although it seems consistent in the 5 patients that's the maximally tolerated dose. So, any thoughts on PSA50, how we should be thinking about that in terms of response? And then I've got a follow-up.

Speaker 3

The end of the call. I think PSA50 is definitely an indicator that something is happening to the patient. I'm not aware of comprehensive data sets the to let you really look at that versus resist response, that's what I'm assuming your question was. I'm not aware of good data sets to let you look at coordinates there because the It hasn't been standard to look at resist in the clinical trials in that prostate community over the years. Now I think that's changing, but the We'll wait and see.

Speaker 3

I just want to emphasize that concordance with PSA50s or not, that program, zalaritimig, the saw really outstanding resist responses in people with measurable tumors. I do know that just from all of the prostate the cancer doctors we've worked with and talked to, they view PSA50 as a good thing if it drops sorry, a good thing if you can achieve it, the How it concords with the specifics of an individual patient, there is not enough data.

Speaker 4

Okay, got it. That's helpful. And then just one more on the royalty sale. The Is the decision to do this versus another financing option that you may have at your disposal the In terms of the pull forward of the expected economics, what and how important was it to maintain the upside at the on the 2 assets, just trying to get a sense of your conviction on the opportunity. Thanks.

Speaker 3

The I think it was very important to maintain the upside on the assets, because there's a lot of momentum in certainly ULTOMIRIS the sales and I think there's a lot of data still coming for MANGERVY as that landscape in lymphoma continues to evolve. And so we it was Critically important for us to have the caps for MONJAVI, that sort of total overall cap and then the annual caps

Speaker 4

the

Speaker 3

conference call. We're excited by both molecules. I think that why we did the deal, the I think it's because the equity cost of capital now in the markets is very challenging. And we've got a lot of the programs we want to invest in, particularly around these T cell engagers. So it made sense to do the royalty deal.

Speaker 3

We've been monitoring the royalty markets now for, the Gosh, 4 years now since we've started and we've all we're always looking for when the timing is right from both the deal side and our needs side and this was when it all came together.

Speaker 5

Great. Thank you. The end of the call. Thank you.

Speaker 1

One moment for our next question.

Speaker 5

The end of the call.

Speaker 1

Our next question comes from the line of Boris Peaker from TD Cowen. Your line is now open.

Speaker 12

The Great. Thanks. This is Nick on for Boris. Just a quick one for me. But for XmAb-eight zero eight, I know it's targeting B7 H3.

Speaker 12

The There are a lot of companies who are now looking at B7 H4 that's kind of become like an interesting space for people, and for some docs. So just wondering what you guys think about that and like the difference between B7H3 versus B7H4 and how B7H3 could potentially the outperform B7H4. What just general thoughts on that. Thanks.

Speaker 13

Yes. I mean, they're 2 really different targets. I mean, the The reason they're called B7s is they're part of the B7 family, which includes CD80, CD86, PD L1, so on and so forth. But when we look at them in terms as targets for the T cell engagers or ADCs. They have like kind of some overlap, but lots of non overlap the in terms of which histology they're overexpressed in.

Speaker 13

I think of B7H4 as like a cervical cancer, triple negative cancer the end of the quarter, whereas I think of B7 H3 as being broadly overexpressed across a much wider range of histologies.

Speaker 12

That's helpful. Would you ever think about going into B7H4 then or is that like a later on in

Speaker 13

the slides. Yes, we certainly thought

Speaker 11

about it. I mean,

Speaker 13

there's already there is a B7 H4 the CD3 T cell engager in Phase 1, I believe. And we're we would prefer to work on targets that somebody else the end of the call, which is already tackling. And in fact, we're making a lot of internal investments on finding novel targets the

Speaker 1

Thank you. The end of

Speaker 5

the call. The end of the call.

Speaker 1

Our next question comes from the line of Peter Lawson from Barclays. Your line is now open.

Speaker 14

The Hey, good afternoon. This is Alex on for Peter. Thank you for taking our questions. Just on the 8/19, your ENPP3 bispecific the program. Have you started dosing patients with the subcu formulation or are you just are you still dose escalating

Speaker 3

at the end of the call. We expect to have I honestly don't know if as of today the subcu started, but the It's very imminent. We've opened it and I just don't know. We'd have to text our medical lead on that one. The So it's up and running and if not today very, very shortly on the subcu.

Speaker 3

We're planning on running them in parallel. We wanted to get the IV going at first the Just to get a little data, get the ball rolling and then that way we could start the subcu with a little bit of knowledge, but no, they're both going to go, Priscilla.

Speaker 14

The Okay, great. And so when you report Phase 1 data, would you anticipate having a recommended Phase 2 dose at that point?

Speaker 3

The Sorry, could you repeat? I was distracted for a second.

Speaker 14

The end of the call. No worries. When you report Phase 1 data, would you anticipate having a recommended Phase 2 dose?

Speaker 3

At That's the idea, yes.

Speaker 14

Okay, great. Thank you.

Speaker 5

The end of the call.

Speaker 1

Thank you. One moment for our next question.

Speaker 5

The end of the call.

Speaker 1

Our next question comes from the line of Mara Goldstein from Mizuho. Your line is now open.

Speaker 15

The end of the call. Hi, this

Speaker 2

is Jerry Gong on for Merritt Goldstein.

Speaker 15

Thanks for taking our questions. First on XmAb306, the Could you share when you might expect to be eligible to receive milestones? And for the second question, the On vedalumab, what are your thoughts on positioning that candidate in renal cell given competitor PD-one and CTLA-four bispecific

Speaker 3

the So first, I'll just touch on the 306. The We're finalizing the details of the contract conversion, and we do have development, we expect to have development in the regulatory and commercial milestones and a sort of a standard structure. I couldn't speculate on as to the timing yet unfortunately. The We'll of course disclose a lot of details commensurate with how we usually disclose for licensing contracts when that amendment is finalized. The For vudalumab, if I understood properly, you have your question is about the Positioning in RCC?

Operator

Yes, because of the

Speaker 5

recent data.

Speaker 3

Right, right. You want to take that one, Nancy?

Operator

The Yes. I mean, we're aware of, I can't say the 5,752 products in renal. The Some of these names are challenging. And it's very interesting with great the high efficacy. Looks like the toxicity is manageable.

Operator

And so we're pleased to see a product in the same class as vedalumab showing activity like this. I mean, it helps the Confirm that this is a product that's going to be important in different tumor types. We're not going into renal cancer ourselves. The end of the call. We made decisions a few years ago on based on Phase 1 data into which tumor types we'd go into.

Operator

The It was a span of tumor types, and eventually we decided on to go into some that were the checkpoint sensitive and some that were checkpoint resistant and that's kind of where we are right now. We're probably not going to add another tumor type after we added lung in the last year.

Speaker 15

Got it. And if I may ask one more question, the end of the call. Also wishing John best wishes. When do you expect to target a new CFO in your search? I'm

Speaker 3

sorry, what do you expect to when? When? Yes. Oh, yes, I mean, starting the search right now. We're starting the search right now.

Speaker 3

This is going to be a long hard search to replace John, so we've got to start now if we're going to be ready

Speaker 1

the

Speaker 5

the end of the call.

Speaker 1

Our last question comes from the line of Brian Chiang from JPM. Your line is now open.

Speaker 16

The Hey, guys. Thanks for taking my question. John is also set to see you go, looking forward to reconnecting in the future. But the end of the call. Just on 564, I recall that we may be expecting some psoriasis data sometime in the early part of next year.

Speaker 16

At the end of the year. So the first is, can you just talk about the timing of the data read? Have you been able to narrow the timing of the of your guidance? The end of the call. And also, as you think about psoriasis as a testing ground for 5, 6, 6, 6, 6, 4, mechanistically, the end of

Operator

the call. Do you have

Speaker 16

a sense of what we should expect in terms of using past these scores? What past these scores are you aiming for the end of the year. Thank you. Thank you. The Thank you for taking

Speaker 5

my question today.

Speaker 3

Hey, thanks Brian. I'll take the second one first. The So we've always intended psoriasis as a population where we could gather the critical biomarker data, which is the peripheral biomarker the Peripheral blood biomarker data is on Treg counts, the opposing cell types that you don't want to have expand, because we have to from regulatory reasons the end of the call. So psoriasis is a great way to do that and you have easy access to the biopsy samples, if you want to go there to get additional information. So we've always been targeting in the psoriasis population, the Treg counts and numbers to select the dose in a dosing interval rather than looking at PASI scores as a driver.

Speaker 3

That's something I think we've guided since we started. The We did add the atopic dermatitis based on intriguing very early and small numbers durability data we saw last year from a competitor program as a way to sort of glean potential there. And so that's that was sort of the rationale for AD. The But in that case as well, it was to glean durability and long term potential sorry, long term sort of disease remitted potential generally for the end of the quarter. We think both of those areas are difficult and challenging and very large indications.

Speaker 3

And we've of course been looking around at other the Smaller indications as we've mentioned, we'd be ready to disclose as we go get closer to the time to jump off onto the next set of trials once we're done with the end of the call. As for timing, we're still guiding to 2024 and we'll fill you in when we get there.

Speaker 1

The Thank you. The end of the call. This concludes the question and answer session. I would now like to turn it back to Basel Dahiyat for closing remarks.

Speaker 3

The end of the call.

Speaker 5

I would just like to say to everybody, thank you so much

Speaker 3

for joining us this afternoon and have a wonderful evening.

Speaker 5

The end of the call.

Speaker 1

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

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Earnings Conference Call
Xencor Q3 2023
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