Q2 2020 Xencor Inc Earnings Call

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Good afternoon, ladies and gentlemen, and thank you for standing by welcome to the second quarter 2020, Xencor Conference call.

Operator: Ladies and gentlemen, and thank you for standing by. Welcome to the second quarter 2020 Xencor conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To participate in that portion of the call, you will need to press star 1 on your telephone. If you require any further assistance, please press star and zero.

This time, all participants are not listen only mode. After the speakers presentation. There will be a question and answer session to participate on got portion of the cool you would need to press star one Oh your telephone.

If you required any further assistance. Please press star and zero now I will like to trend coal to your speaker today, Charles Slide head of Investor Relations.

Charles Liles: Now I would like to turn the call over to your speaker today, Charles Liles, Head of Investor Relations. Thank you and good afternoon. Earlier today, we issued a press release that outlines the topics we plan to discuss today. The press release is available at www.xencor.com. Today on our call, Basil Dahiyat, President and Chief Executive Officer, will provide updates regarding COVID-19, and our partner, Allen Yang, Chief Medical Officer, will review recently presented clinical data. John Desjarlais, Chief Scientific Officer, will provide updates on preclinical development. And John Kuch, Chief Financial Officer, will review the financial results.

Thank you and good afternoon.

Earlier today, we issued a press release, which outlines the topics we plan to discuss today. The press releases are available at Www Dot Xencor dotcom.

Today on our call vessel that President and Chief Executive Officer will provide updates regarding overnight union or partnerships, Alan Yang Chief Medical Officer for where do you recently presented clinical data someday, Charlie Chief Scientific Officer will provide updates from preclinical development and John Cushe, Chief Financial Officer, Well review financial results and then we'll open up the call.

Charles Liles: And then we will open up the call to your questions. 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, future market conditions, the plans and objectives of management for future operations, the company's partnering efforts, capital requirements, future product offerings, research and development programs, and the impacts of the COVID-19 pandemic on these topics. 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 outcome of the events described in these forward-looking statements is subject to known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially from the results anticipated by these forward-looking statements, including, but not limited to, those factors contained in the risk factors section of our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q.

If your question.

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 future market conditions, the plans and objectives that management for future operations, the company's partnering efforts capital requirements future product offerings research and development programs.

Perhaps of the Coca 19 pandemic on these topics before looking statements are not historical facts, rather are based on our current expectations and beliefs are based on information currently available to us the outcome of the events describing these forward looking statements are subject to known and unknown risks uncertainties and other factors that could cause actual results to differ materially from the results anticipated by these four.

Looking statements, including but not limited to those factors contained in risk factor section for most recently filed and report on form 10-K in quarterly report on form 10-Q with that let me pass the call over to Battle.

Charles Liles: With that said, let me pass the call over to Basil.

Bassil I. Dahiyat: Thanks, Charles, and good afternoon, everyone. Xencor's approach to creating antibody and cytokine therapeutics is centered around our XMAB protein engineering platform. By making small changes to an antibody structure, specifically in its SC domain, we can improve its natural functions and performance and create new mechanisms of therapeutic action. The plug-and-play nature of our suite of XMAB FC domains allows us to engineer nearly any antibody to have improved activity, longer half-life, or bi-specific structure. This flexibility and portability enables us to take multiple shots on goal simultaneously in the clinic and generate proof-of-concept data to guide which programs will independently advance, which will partner, and which will terminate. We're focusing our R&D on the expansion and use of our XMAB bi-specific platform to create antibodies that bind two or more different targets simultaneously and also to engineer cytokines with structures optimized for particular therapeutic use. We're currently running six phase one clinical studies evaluating these XMAB bi-specific antibodies. Now, before I give an update on some of our partnerships, we want to provide a brief update on the impact of the COVID-19 pandemic on our operations. The pandemic did not significantly disrupt patient enrollment in Xencor's six ongoing clinical trials during the second quarter.

Thanks, Charles and good afternoon, everyone.

Then of course approach to creating antibody and cytokine therapeutics is centered around our X men protein engineering platform like making small changes twin antibody structure, specifically that's FC domain, we can improve its natural functions and performance and create new mechanisms of therapeutic action.

Play nature of our suite of X now above sea demands allows us to engineer nearly any antibody to have improved activity longer half life or by specific structure.

Flexibility and portability enabled us to take multiple shots on goal simultaneously in the clinic Jinri proof of concept. They did guide, which programs will independently advance, which will partner which will terminate.

Focusing our R&D on the expansion and use of our ex that by specific platform to create antibodies applying more different targets simultaneously.

Also to engineer cytokines with structures optimized for particular therapeutic use.

Now we're currently running six phase one clinical studies evaluating subjects not by specific.

Now before I update on some of our partnerships we want to provide a brief update on the impact cobot Nike pandemic on our operational.

I could not significantly disrupt patient enrollment to think were six ongoing clinical trials.

Order However, our study initiation for bike Dakota map as previously disclosed have been delayed as many clinical sites have delayed the trial startup process.

Bassil I. Dahiyat: However, our study initiations for Vibocodumab, as we've previously disclosed, have been delayed, as many clinical sites have delayed the trial start-up process. We had modestly slowed enrollment in the CD3 bispecific antibody studies attributable to COVID-19, but this had no effect on our studies for the three-tumor microenvironment activator molecule. Now, as is still the case today, as it was three months ago, unfortunately, the situation is very fluid, and we'll continue to update it as soon as we can.

We had modestly slowed enrollments in the Cdthree Bispecific antibody studies attributable to cope with 19 and no effect on our studies for the three tumor microenvironment activator molecule.

Now I'd still the case today as it was three months ago. Unfortunately, the situation is very fluid and we'll continue to updated as soon as appropriate.

No within the company, we've implemented a number of measures to protect the health and safety of our employees and of our community. You include some laboratory operation adjustments.

Bassil I. Dahiyat: Now, within the company, we've implemented a number of measures to protect the health and safety of our employees and of our community. These include some laboratory operation adjustments, symptom self-assessment guidelines, and weekly SARS-CoV-2 virus testing at our facility. Additionally, we are maintaining a requirement for all non-laboratory employees to work remotely.

Symptoms self assessment guidelines and weekly Sars koby to virus testing at our facility. We are maintaining requirement for online laboratory employees to work are mostly.

Bassil I. Dahiyat: Okay, now on to partnership. A core part of our business is to complement our internal development portfolio with partners. These partnerships generate payments from the licensing of XMAP technologies, the clinical advancement of XMAP candidates, as well as royalties from sales of approved products. There were no COVID-19 impacts here during the second quarter as we continue to earn revenues from partners like Alexion and Gilead, but we will continue to monitor potential impacts. Partnerships like these really highlight the plug-and-play nature of the suite of XMAB FC domains we've created.

Okay now onto a partnership.

A core part of our businesses to complement for internal portfolio internal development portfolio with partners.

These partnerships generate payments from the licensing to backstop technologies, the clinical advancement of excellent candidates as well as royalties from sales of approved products.

Were no carbon 19 impacts here during the second quarter as we continue to earn revenues from partners like left field and Gilliat.

We will continue to monitor potential impacts of course.

[noise] partnerships like these really highlight the plug and play nature of the suite of Exenatide FC domain.

Bassil I. Dahiyat: With the small changes to the FC structure that we've engineered, we can, for nearly any antibody, improve its activity, half-life, or readily create biospecific structures. We have 11 ongoing partnerships for XMAP technology, which have resulted in two marketed products, seven clinical stage candidates, and more in the earlier stages of development. The most significant recent development among our partners occurred just this past Friday, with the early FDA approval of Morphosis' Tafacitimab, which they licensed from us in 2010, when it was known as ExMab 5575. It's an antibody that we created and put our XMAP cytotoxic FC domain onto. We also initiated its clinical development, running the Phase 1 trial. Its trade name is now Monjuvi.

With the small changes CFC structure that we've engineered we can for nearly any antibody improve the activity half life more readily create by specific structures.

We have a loving ongoing partners 11 ongoing partnerships Rex enough technology, which resulted now into market of products seven clinical stage candidates and more in the early she's the development.

The most significant recent development among our partners Kurt just this past Friday with the early after the approval of Morphosis is tacit about if they licensed from US in 2010, when it was noted Xmab 5574.

It's an antibody, we created and put our X and outside of toxic FC domain on too.

Also initiated its clinical development running the phase one trial.

It's a trade name has now been Judy.

It's a cdnineteen directed side, a little Cana body indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma, not otherwise specified.

Bassil I. Dahiyat: It's a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arriving from low-grade lymphoma and who are not eligible for autologous stem cells. This approval is the first for second-line treatment of DLBCL from the FDA. Now, we couldn't be happier here at Xencor, as this approval expands the options for patients with this difficult-to-treat blood cancer. Mondrivee will be co-commercialized in the U.S. by Morphosis and Insight, and the European Marketing Authorization application for Taffa Cinemat is currently under review by the E.M. Now, from time to time, we enter into research collaborations that include the creation Amgen is a prime example. AMG509 is Amgen's STEEP1 by CD3 XMAB 2 plus 1 bispecific antibody. Now, that was developed under our collaboration.

Including deal Bcl arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

This approval is the first for second line treatment, if you'll be field from the FDA.

No we couldn't be happier here at Suncor is this approval expands the options for patients with its difficult to treat blood cancer MSB will be co commercialize in the U.S. My Morphoses insight, India European marketing authorization application for testing that is currently under review by the Yemen.

Now from time to time, we intend to research collaborations and include the creation of novel ex met by specific antibody.

Yes, My partners and has a Prime example.

Empty Fivenine is amgen steep one by Cdthree X map to plus one by specific antibody now that was developed under our collaboration with them, they're developing games you fivenine for patients with prostate cancer and using sarcoma and a phase one studies currently recruiting for patients with advanced prostate cancer.

First by specific antibody that Amgen developed under this collaboration is A.M.D. four to four cdthirty eight by Cdthree by specific antibodies. They evaluated in a phase one study in patients with multiple myeloma.

Amgen terminated the program in the second quarter indicated the program we stopped for adverse events that were likely CD 38 target related.

Under the terms the agreements the rights to the Cdthirty eight program, including 84 to four revert because encore and the company's currently assessing b assets potential for further development, including three different patient populations and applying mitigating treatments for the adverse events.

Bassil I. Dahiyat: They're developing AMG-509 for patients with prostate cancer and human sarcoma, and a Phase I study is currently recruiting patients with advanced prostate cancer. The first bispecific antibiotic that Amgen developed under this collaboration is AMG-424, a CD38 by CD3 bispecific antibiotic that they evaluated in a Phase I study in patients with multiple myeloma. Amgen terminated the program in the second quarter and indicated the program was stopped for adverse events that were likely CD38 target-related. Under the terms of the agreement, the rights to the CD38 program, including AMG 424, revert to Xencor, and the company is currently assessing the asset's potential for further development, including treating different patient populations and applying mitigating treatments to the adverse events. Now, the plug-and-play nature of Our strategy is to selectively license access to our XMAP technologies for creating and developing antibodies with improved properties. For example, Alexion's Ultamiris, a C5 complement inhibitor, uses Xtend technology for a longer half-life. The program continues to receive marketing authorizations worldwide, the last of which was European approval for adults and children with atypical hemolytic uremic syndrome in June.

Now the plug and play nature of our X men technologies and able to additional partners like Lexia earnings year to advance their programs using very little resources rather from us.

How did he is the selectively license accessed waxman technologies for creating a developing antibodies and approved property.

Let's see on ultra Myris a C. Five complement inhibitor uses extent technology for longer half life.

Group continues to receive marketing authorizations worldwide, the last of which was the European approval for adults in Chile children's atypical hemolytic Uremic syndrome. This June.

In addition to evaluating alternatives and abroad late stage development program Alexey honest currently conducting a randomized controlled phase three study in hospitalized patients with advanced Koby Nike.

Our partnership with Veer biotech shows a broad applicability of our technology in areas such as viral infectious disease.

Your has not exclusive access to our extend FC technology to extended half life of beer 73, one into your 73 too [laughter]. Both novel antibodies that are investigating potential treatments for patients with Kevin Nick.

Plan to submit an eye and de for view or 73, one it come into phase two pre clinical trial program in August and they plan to initiate a study evaluating pier 73 twos later this year.

I'll now turn it over to John differently Who'll provide an update on some of our preclinical programs and our new discovery and development collaboration with Craig.

John.

Yeah. Thanks bezel.

Yeah, but of course X men Biospecifics FC domain specific credits would able to rapid designed to simplify development a bias to the cannibalize could buy two or more different targets.

First in class, we have developed were Cdthree bispecific antibodies that contain one ethic tumor binding domain and one cdthree body limit.

Given the Cdthree on T cells promotes recruitment activation of T cells against the tumor cells.

Bassil I. Dahiyat: In addition to evaluating Ultamiris in a broad, late-stage development program, Alexion is currently conducting a randomized, controlled Phase III study in hospitalized patients with advanced COVID-19. Our partnership with Veer Biotech shows the broad applicability of our technology in areas such as viral and infectious diseases. VeeR has non-exclusive access to our XtendFT technology to extend the half-life of VeeR 7831 and VeeR 7832, both novel antibodies that they're investigating as potential treatments for patients with COVID-19. They plan to submit an IND for VeeR 7831 and commence a phase two, three clinical trial program in August, and they plan to initiate a study evaluating VeeR 7832 I'll now turn it over to John Desjarlais, who will provide an update on some of our preclinical programs and our new discovery and development collaboration with Atreco.

Yeah, I commend them separately T cells doesn't have to be limited the CD three though for example, we're also investigating by civic antibodies that targets Cdtwenty eight a key costimulatory receptor on T cells. Importantly, we designed the CD 28, and gauges to actually only what about the tumor cells with the goal of avoiding the Super Agonism, it's less of the disastrous clinic for.

Some other companies targeting see 28, nearly 15 years ago.

More near term however, we've developed a mixability formats or X men to close one by specific antibody with two domains appointed tumor targets at a single demand the find cdthree.

These antibodies me preferentially kill tumor cells and high target expression and they potentially avoid blow expressing normal cells, taking advantage of a property called a busy we believe these properties will be particularly important for many solid tumor targets.

Presented preclinical data for three internally developed two plus one by six at the second session of the HCR meeting in late year.

Pre clinical models feel strong selected tumor killing from two plus one program to target appears to me he's a ceiling and U.P.P. three the last of which is under explored tumor antigen overexpressed sudden renal cell carcinoma.

These targets, although they tend to be strongly express some prostate cancer ovarian cancer in kidney cancer, respectively. Can also have some normal tissue expression, suggesting they are good applications for this important.

The MPP three program experts real eight onenine, it's the most advanced disease.

Clinical data and Keith that's ex that's really what nine buys preferentially the tumor cell compared to normal cells and effectively recruits T cells to kill tumor cells worse, if we.

John R. Desjarlais: Yeah, thanks Basil. Xencor's XMAT biocivic FC domains were specifically created to enable the rapid design and simplified development of biocivic antibodies to combine two or more different targets. The class that we have developed were CD3 biocivic antibodies that contain one anti-tumor binding domain and one CD3 binding domain. Engagement of CD3 on T-cells promotes recruitment and activation of T-cells against the tumor. The activated receptor on T-cells doesn't have to be limited to CD3, though.

Demonstrates strong reversal tumor growth in tumors intergraph levels, yeah. It was well tolerated with expected pharmacodynamics and it antibody like half life and non human primate.

You're planning to filed I envy for extra up 3.19 to 2021.

Finally last month, we formalized the collaboration with the Trico to research developing course life cdthree engaging by civic antibodies to novel targets.

The tree 'cause unique discovery platform conflicts or protein engineering capabilities by providing novel two more selective antibodies and targets the coupled with our cdthree bias to the platform.

Up to two joint programs will be mutually selected for further development of commercialization, but each partner sharing costs and profits equally.

John R. Desjarlais: For example, we are also investigating biocivic antibodies that target CD28, a key co-stimulatory receptor on T-cells. Importantly, we designed these CD28 engagers to activate only when bound to tumor cells with the goal of avoiding the super agonism that led to the disastrous clinical experience of other companies targeting CD28 in the early 15 years. More near-term, however, we have developed a mixed valency format, our XMAB 2 plus 1 bisynthic antibody, with two domains that find a tumor target and a single domain that finds... These antibodies may preferentially kill tumor cells with high target expression and may potentially avoid low-expressing normal cells. Taking advantage of a property called a, We believe these properties will be particularly important for many solitude workers. We presented preclinical data for three internally-developed 2 plus 1 biocytics at the second session of the ACR meeting in late. Preclinical models show strong, selected tumor killing from 2 plus 1 programs that target PSMA, mesothelin, and EMPP3, the last of which is an underexplored tumor antigen overexpressed in renal cell culture. These targets, although they tend to be strongly expressed in prostate cancer, ovarian cancer Suggesting there are good applications for this new format.

Each company will lead one of the joint program.

Agreement also allows for each quarter to pursue up to two programs independently.

This collaboration offers but then corn to treat go with several opportunities that had bad novel first in class Cdthree classification, the body central treatment to patients with cancer.

With that Alan Yang will review, our clinical portfolio Alan.

Thanks, John.

In May we provided initial dose escalation data from our ongoing phase one study evaluating X map 20, 717 patients with advanced solid tumors X men 20, 717 is a dual PD one see till they for checkpoint inhibiting by specific antibody. We have to me antibodies affinities for PD, one and see feel like four for selective engagement of T cells.

Expressing both targets, which distinguishes it from combination therapy and most specific by specific checkpoint inhibitors.

T cells that have multiple checkpoint expression or typically found more in the tumor micro environment than in the periphery all of our tumor microenvironment activators as we call them seeks to more effectively reactivate these tumor reactive T cells than existing therapies. This design is meant to drive improved tolerability at higher doses compared to the dosing of separate.

<unk>, Chile for anti PD, one antibodies for example, which is deliver better responses at the cost of Tolerability.

John R. Desjarlais: The EMPP3 program, EXMEP 30819, is the most advanced. The clinical data indicate that XMAP30819 biases preferentially to tumor cells compared to normal cells and effectively recruits T-cells to kill tumor cells. It demonstrated strong reversal of tumor growth in tumor xenograft models, and it was well tolerated with expected pharmacodynamics in an antibody-like half-life in We are planning to file an IND for XMAP 30819 in 2021. Finally, last month, we formalized a collaboration with Atrica to research, develop, and commercialize CD3-engaging biocivic antibodies against novel targets. DRIKA's unique discovery platform complements our protein engineering capabilities by providing novel, tumor-selective antibodies and targets to couple with our CD3 biostimulant platform. Up to two joint programs will be selected for further development and commercialization, with each partner sharing costs and profits. Each company will lead one of the joint, and the Agreement also allows for each partner to pursue up to two programs independently. Collaboration offers both Xencor and Atreeca several opportunities to advance novel, first-in-class CD3 biospecific antibodies for the potential treatment of patients with cancer. With that, Allen Yang will review our clinical report. Allen

In our first six dose escalation courts, we observed a X about 27, one seventh to be generally well tolerated and heavily pretreated patients consistent with our hypothesis of inhibiting both PD, one and see till before we observed a robust dose dependent increases in biomarkers of T cell activation and Pharmacodynamic.

To be consistent with blockade of both receptors. It was also encouraging to observe cases of clinical activity as we moved into the higher dose cohorts, which we detailed in the press release in May.

Based on these data we opened expansion cohorts and several tumor types at 10 milligram per kilogram as well as additional dose escalation carts, starting at 15 milligrams per kilogram as we did not reach the maximum tolerated dose expansion cohorts for patients with melanoma and advanced non small cell lung cancer are fully enrolled.

We look forward to sharing continued progress from the 20 717 program as well as our other tumor microenvironment targeting by specific any program antibody programs in phase One studies X map 23, one for targets PD, one and the co stimulatory receptor isos and ex map 22, eight for one which targets the checkpoint.

So you feel like for unlike three the latter which has began dosing patients in combination with pembrolizumab.

Moving on to our clinical Tc clinical stage T cell Engagers. These are tumor targeted by specific antibodies that contains both the tumor antigen binding domain and the cytotoxic T cell binding domain, specifically cdthree binding domain BCD three by specific activate T cells at the site of the tumor in order to potentially killed Mulligan.

Allen S. Yang: Thanks, John. In May, we provided initial dose escalation data from our ongoing Phase 1 study evaluating XMAP2717 in patients with advanced solitary. XMAB 2717 is a dual PD-1 and CTLA-4 checkpoint-inhibiting bispecific antibody. We have tuned the antibodies' affinities for PD-1 and CTLA-4 for selective engagement of T cells expressing both targets, which distinguishes it from combination therapy and most bispecific checkpoint inhibitors. T-cells that have multiple checkpoint expression are typically found more in the tumor microenvironment than in the periphery.

So.

We continue to dose patients in our phase one studies the by the code them out, which targets CD 123, and acute myelogenous leukemia, and promote them out which targets Cdtwenty b cell malignancies, and that's because we have previously because we plan to initiate additional clinical programs subject to impacts from the coping 19 pandemic likely next year.

Allen S. Yang: All of our tumor microenvironment activators, as we call them, seek to more effectively reactivate these tumor reactive T-cells than existing therapy. This design is meant to drive improved tolerability at higher doses compared to the dosing of separate anti-TLA-4 and anti-PD-1 antibodies, for example, which has delivered better responses at the cost of tolerability. In our first six-dose escalation cohorts, we observed that XMAD2717 was generally well-tolerated in heavily pre-treated patients. Consistent with our hypothesis of inhibiting both PD-1 and CTLA-4, we observed robust dose-dependent increases in biomarkers of T-cell activation and pharmacodynamic activity consistent with blockade of both receptors. It was also encouraging to observe cases of clinical activity as we moved into the higher dose cohort, which we detailed in the press release in May. Based on these data, we opened expansion cohorts in several tumor types at 10 mg per kg, as well as additional dose escalation cohorts starting at 15 mg per kg, as we did not reach the maximum tolerated dose. Expansion cohorts for patients with melanoma and advanced non-small cell lung cancer have been fully enrolled.

We also continued to those patients in a phase one study uptight do the math, which targets the somehow to start interceptor too and we expect that we will present initial data from these ongoing this ongoing study in patients with neuroendocrine tumors in the second half of this year.

Finally, we're developing suite of cytokines, which are immune signaling proteins that are built on the xmab Bispecific FC domain and incorporate the extent technology using our FC domain and tuning the potency is unable cytokine with approved drug like properties, such a slower receptor mediated clearance and longer half life. After 10.

At least superior Tolerability, our first cytokine program and lead in our collaboration with Genentech is X map 24, three or six which they call RG six three to three it's an Io 15, I all 15 receptor Alpha complex fused with our bi specific FC domain. It targets the expression expansion and activation of T cells and now.

I'll kill ourselves.

That's correct is currently enrolling patients in a phase one study evaluating ex about 24, three or six and quickly moving in combination with a test Elizabeth their anti PDL. One antibody we plan to explore a number of our own combination studies pending completion of the initial dose escalation study.

Allen S. Yang: We look forward to sharing continued progress from the 27.1.7 program, as well as our other tumor microenvironment targeting by specific antibody programs in Phase I studies. XMAP 23.1.4 targets PD-1 and the co-stimulatory receptor ITOS, and XMAP 22.8.4.1, which targets the checkpoint, CTLA-4, and LIG-3, the latter of which has begun dosing patients in combination with pembrolizumab. Moving on to our clinical-stage T-cell engages, these are tumor-targeted bispecific antibodies that contain both the tumor antigen binding domain and the cytotoxic T-cell binding, specifically CD3 binding domain. These CD3 bispecifics activate T-cells at the site of the tumor in order to potentially kill malignant cells. We continue to dose patients in our phase one studies of ibucodumab, which targets CD123 in acute myelogenous leukemia, and plimodumab, which targets CD20 in B-cell malignancy.

We also look forward to keep you informed about all our clinical programs as they progress now I'll hand, the call over to John Cushe, who will review the second quarter and first six months financial results John.

Thank you Alan.

Sincor continues to maintain a strong financial position, which enables us to support our portfolio clinical research stage by specific antibody and try to kind of drug programs.

Our diversified portfolio partnerships and collaborations continue driving some upfront payment milestones and royalties.

Foreign sources of non dilutive capital.

With the FDA approval, most if not you movie last Friday, we will receive a $25 million milestone payment.

<unk> recognizes revenue in the third quarter.

As a reminder, girls eligible to receive royalties on worldwide net sales.

I signaled low double digit percentage range and additional development regulatory and sales milestone payments.

At June 30, 2020, a cash cash equivalents smart roll in equity Securities totaled 587.4 million.

Allen S. Yang: And as we have previously disclosed, we plan to initiate additional clinical programs subject to impacts from the COVID-19 pandemic, likely next year. We also continue to dose patients in the Phase I study of Tidodomab, which targets the somatostatin receptor 2, and we expect that we will present initial data from this ongoing study in patients with neuroendocrine tumors in the second half of this year. Finally, we're developing a suite of cytokines that are immune signaling proteins that are built on the XMAB bispecific SC domain and incorporate the Xtend technology. Using our FC domain and tuning the potencies enable cytokines with improved drug-like properties such as slower receptor-mediated clearance and longer half-life, and potentially superior tolerability. Our first cytokine program and lead in our collaboration with Genentech is XMAD24306, which they call RG6323.

Appeared to 601.3 million at December 31st 2019.

The decrease reflects cash used to fund operating activities for six months to 2020 offset by upfront payments milestone payments and royalties from our partnership in licensing arrangements.

For the second quarter 2020 revenues were 13.1 million compared to 19.59 for the same period between 90.

These revenues include royalty revenue from election, and licensing revenue from Killian versus same period between 19 revenue was primarily reflect research collaboration revenue from Genentech in itself and muscle revenue from Alexia.

The first six months 2020 revenues were 45.5 million compared to 131.4 million for the same period 29.

I residents in 2020 include warranty rather than from left him now so rather than for more closely and licensing revenue from Mark Iliad, Amy collaborations content licensing collaboration revenue earned from Genentech and Astelit between 90.

Research and development expenditures through second quarter, 2020, 43.5 million compared to 33.3 million for the same period 2019.

Allen S. Yang: It's an IL-15, IL-15 receptor alpha complex fused with our bi-specific FC domain. It targets the expansion and activation of T-cells and natural killer cells. Genentech is currently enrolling patients in a Phase I study evaluating ExMAD-24306 and quickly moving it in combination with atezolizumab, their anti-PD-L1 antibody. We plan to explore a number of our own combination studies pending completion of the initial dose escalation study. We also look forward to keeping you informed about all our clinical programs as they progress. Now, I'll hand the call over to John Kuch, who will review the second quarter and first six-month financial results. John?

After the first six months in 2020, it was 77.4 million compared to 61.5, Meg and same period between 90.

The increases in Argentina is probably two increased spending on excellent motor bad and actually have 27 months seven clinical programs as well as our preclinical aisle to cytokine program X men 27.64, and our preclinical N. P. P. Three by Cdthree to close one by specific antibody program X maps Camille equal mine.

Both of which we've advanced into R&D, enabling activities, we know because there was lower spending in 2020, and I actually have 24.43 or six and Opex allomap programs.

John J. Kuch: Xencor continues to maintain a strong financial position which enables us to support our portfolio clinical research stage by specific antibody and cytokine drug programs. Our diversified portfolio of partnerships and collaborations continues to provide us with upfront payments, milestones, and royalties, important sources of non-delivered capital. With the FDA approval of Morphosis Montjuvi last Friday, we will receive a $25 million milestone payment, which we will recognize as revenue in As a reminder, we are also eligible to receive royalties on worldwide net sales in the high single-to low double-digit percent range and additional development, regulatory, and sales milestone payments.

General administrative expenses from second quarter, 2020 were 7.2 million compared to 5.8 million seem to keep.

For six months and 2020 Genie expenses were 14.4 million compared to 11.3 million for the same to 20 Nike.

Capital spending here is primarily due to increased staffing and spending at professional fees.

And that lost from second quarter, 2020 was 35 million or 61 cents I'm pleased to lose share basis compared to a net loss of 16 million or 20 cents on policeman saloon cheer up here the basis for same period in 2019.

Our net loss reported 2020 is partly due to lower partnership and collaboration revenue and higher R&D expenses 2020.

John J. Kuch: At June 30, 2020, our cash, cash equivalents, marketable, and equity securities totaled $587.4 million, compared to $601.3 million at December 31, 2019. The decrease reflects cash used to fund operating activities in the first six months of 2020, offset by upfront payments, milestone payments, and royalties from our partnership and licensing arrangements. For the second quarter of 2020, revenues were $13.1 million compared to $19.5 million for the same period in 2019. These revenues include royalty revenue from Alexion and licensing revenue from Gilead, compared to the same period in 2019, where revenues primarily reflect research collaboration revenue from Genentech and Astellas and milestone revenue from Alexion. For the first six months of 2020, revenues were $45.5 million, compared to $131.4 million for the same period in 2019.

First six months and 2020 net loss was 43.1 million for 76 cents.

Im sure basis, compared to net income of 64 million or $1.10 cents, absolutely <unk> per share basis for the same period between 19.

Net loss in the first six months to 2020 compared to many can report for the same period between 19, it's probably didn't revenue recognition marcinek collaboration 29.

Noncash stock based compensation expenses for six months 2020 was 40.7 billion compared to 50.29 for same period between 90.

Total shares outstanding were 67.2 main as of June 30, 2020, compared to 56.59 as at June 30 29.

Based on current operating plans and quirks excess cash to fund research and development programs in operations in the 2024.

And of course expects and 2020 with between 525, and 575 million cash cash equivalents marketable securities equity Securities.

With that we'd now like to open the call for your questions operator.

Thank you and that's I mean minds on maybe some jackman easy I've a question I'd be sometime this press Star then one on your telephone keypad to withdraw your question just because that's how long have scheme.

John J. Kuch: Our revenues in 2020 include royalty revenue from Alexan, milestone revenue from Morphosis, and licensing revenue from Arc Iliad and Aemian Collaborations, compared to licensing and collaboration revenue earned from Genentech and Astellas in 2019. Research and Development expenditures for the second quarter of 2020 were $43.5 million, compared to $33.3 million for the same period in 2019, and for the first six months of 2020, they were $77.4 million, compared to $61.5 million for the same period in 2019. The increases in R&D are primarily due to increased spending on our point-motor MAP and XMAP 2717 clinical programs, as well as our preclinical IL-2 cytokine program, XMAP 27564, and our preclinical ENPP3 by CD3 2 plus 1 by specific antibody program, XMAP 30819, both of which we have advanced into IND-enabling activities.

Our first question pest control with Piper sounds like some scar huh.

Great. Thank you very much can you hear me worker, yes audible.

Oh awesome, congratulations [laughter] approval I'm worker.

Give us I'm so what's the royalties are and whether there are other future milestones beyond the <unk> approval milestone for other indications and things like thanks. So much sure. Thanks, I hope you're shaping staying safe set out would that tropical storm in New York, along with all the other new Yorkers I'm sorry, yes.

[laughter]. So the the royalties are high single to low double digit and their tiered. That's the most detailed were allowed to just at this point there worldwide royalties. So you consider worldwide sales regardless of whether the the company selling his insight or more Oh of course insight as ex U.S.

Commercial rights on there are a sick or significant milestones for both development in other indications within.

Oncology as well as non oncology, though there was no development going on it for that at the moment everywhere else. So there's other oncology indication regulatory development regulatory milestones and there are sales milestones John you want to give a little bit of granularity on the magnitude of those.

John J. Kuch: We note that there was lower spending in 2020 in our EX-MIB 24306 and OBEX-ILMAP programs. General administrative expenses for the second quarter of 2020 were $7.2 million, compared to $5.8 million in the same period in 2019. For the first six months of 2020, G&A expenses were $14.4 million, compared to $11.3 million for the same period in 2019. This show's spending here is primarily due to increased staffing and spending on professional. The net loss for the second quarter of 2020 was $35 million, or $0.61 on a fully diluted share basis, compared to a net loss of $16 million, or $0.28 on a fully diluted share basis, for the same The higher net loss report in 2020 is probably due to lower partnership and collaboration revenue and higher R&D expenses in 2020.

Yeah, the sales milestones are $60 million and the other development regulatory or are anywhere in the 50 $75 million range.

Yes, depending on which ones, we like doesn't have any additional indications.

Great well. Thank you so much and our congrats on another good example of the model working.

Thank you. So much you know, we're very excited about them onto the approval.

[noise] pain care. Our next question comes from at least a young with Cantor Fitzgerald.

Hey, I I basically on funny, Dan or taking a call I guess it first one it's time to do tomorrow, I know you're going to presented some data.

So just wondering can you just talk about what types of data that we might see I'm like how many patients and then can you just frame watch what do they channel on southern response rate on seen with a standard of care and then Jack and I wanted to ask about that I'm guessing Trina.

John J. Kuch: For the first six months of 2020, the net loss was $43.1 million, or $0.76 on a fully diluted per share basis, compared to a net income of $64 million, or $1.10 on a fully diluted per share basis, for the same period in 2019. The net loss for the first six months of 2020 compared to the net income reported for the same period in 2019 is primarily due to revenue recognition margin anti-collaboration.

Collaboration.

Can you just talk about why aren't you guys seem to do you think you.

Sure. So for tied due to map data that we are going to present later this year is for the neuroendocrine tumor population that's within the phase. One. So just that population were STR too is a is it sort of definitive marker for the types of data it's gonna be art.

[laughter] elation data for that trial, which is in advance stage net patients and.

John J. Kuch: Non-cash, stock-based compensation expense for the first six months of 2020 was $14.7 million, compared to $15.2 million for the same period in 2019. Total shares outstanding were $57.2 million as of June 30, 2020, compared to $56.5 million as of June 30, 2020. Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations into 2024. Xencor expects to end 2020 with between $525 and $575 million in cash, cash equivalents, and marketable securities.

That data would be.

Our course, our safety data. So this is a this was a high risk a potential high return program because we know that at this tier two though expressed heavily on the tumors in that are also expressed on various helping her into continues and and we believe there ought to be a therapeutic window that we could design against and so we're testing that hypothesis now with a CD three antibody.

So the type of data would be of course safety data. So that's going to be important thing to look at its going to be a you know what Josephine we've we've gotten up to in this population and of course any efficacy data and biomarker data that that we get out of the patients I note that the standard of care and this tumor type typically hasn't around a 10 percentish response rates.

Operator: With that, we'd now like to open up the call for your questions. Operator. Thank you. And as a reminder, ladies and gentlemen, if you have a question at this time, just press star and then one on your telephone keypad. To withdraw your question, just press the pound or hash key. Our first question is from Ted Tenthoff with Piper Tandler. Please go ahead. Great, thank you very much.

The <unk> response rate.

Because these tumors don't generally regress these usually sort of halted in their tracks and their functionality is reduced.

Alan were there any points that I I missed there about this kind of population.

Yeah, well certainly be did the dose escalation cohorts and we may have some expansion data the terms of meeting, but again not that many patients at this point.

Edward Andrew Tenthoff: Can you hear me okay?

Operator: Oh, awesome. Um...

Operator: Congratulations on the TAPA-CISF approval. I'm wondering...

Yeah, we're talking maybe a couple it doesn't.

Bassil I. Dahiyat: Please give us a sense of what the royalties are and whether there are other future milestones beyond the approval milestone for other indications and things like that. Thanks so much.

Yep.

And then now you wanted me to switch to the discussed the a trynka collaboration.

You know ads for why I think it's because we have a platform that lets us create.

Bassil I. Dahiyat: Sure, thanks, and I hope you're staying safe, Ted, out with that tropical storm in New York, along with all the other New Yorkers... Sorry. Yeah.

Antibodies are really and for a particular.

A particular targeting you speak in Dallas and style Dakota, he's up or down we can make it more selective for high expressing cells and for low expressing cells all depending on the nature of the target.

Operator: Yes, go ahead.

Bassil I. Dahiyat: So the royalties are high single-digit to low double-digit, and they're tiered. That's the most detail we're allowed to share at this point.

John J. Kuch: They're worldwide royalties, so you consider worldwide sales, regardless of whether the company selling is Insight or Morphosis because, of course, Insight is ex-U.S. commercial rights. There are significant milestones for both development in other indications within oncology, as well as non-oncology, though there's no development going on for that at the moment that we're aware of. So there are other oncology indication regulatory, development regulatory milestones, and there are sales milestones. John, do you want to give a little bit of granularity on the magnitude of those?

And and the key ingredient for that kind of approach is of course really exciting targets and we think finding new targets is it is an important endeavor and we thought working with one of the best companies out there that they can find new target antibody pairs and made a lot of strategic sense and so that that's the.

Rationale we want to.

Takes its toll can't we built in applied against the broadest range of biology, we can get too and there's technologies out there for finding new targets and antibody pairs against them that that we don't have rent we have to we have to then find the best out there were there any technical points on that that you wanted to add John or is that that adequately describe it.

Bassil I. Dahiyat: Yeah, the sales milestones are $50 million, and the other development regulatory are anywhere in the $50-$75 million range.

John J. Kuch: Yes, depending on which ones we want... Let's go down to the additional notification key.

Edward Andrew Tenthoff: Great. Well, thanks.

Yeah, I mean, I would just add that you know that we really admired the a threeca.

Bassil I. Dahiyat: Well, thank you so much, and congrats. It's another good example of the model working. Thank you so much.

Platform, you know the idea of taking checkpoint responsive patients and mining there be you saw repertoire as for per new antibody responses that emerge presumably as part of the response to the tumor.

Bassil I. Dahiyat: Thank you so much. You know, we're very excited about Manjibiya.

Operator: Thank you. Our next question comes from Alithea Young with Cantor Fitzgerald. Hey guys, this is Leigh Ann Valencia. Thanks for taking the call. I guess the first one is due to MAP.

And then you know the first thing. They do is then check those antibodies see if the rack with other patients' tumors and putting all that story together just seemed like a perfect fit for what we're trying to do it then core had again a way to access novel targets.

Leigh Ann Valencia: I know you're going to present some data later this year. So, just wondering, can you just talk about what types of data that we might see, like in how many patients? And then, can you just briefly outline for us what the general sort of response rate seen with standard care is? And then, second, I wanted to ask about this Atreeqa collaboration. Can you just talk about what the two of you guys think about, you know, doing this deal? Thank you.

Yeah.

Right.

Thank you.

And our next question comes from Jonathan can we do you Leerink. Please go ahead.

Hi, guys. Thanks for taking my questions.

First question what are your latest thoughts on promote a man development strategy and when could we see the next day to update from that program.

Bassil I. Dahiyat: Sure, so for TIDUTA-MAB, the data that we are going to present later this year is for the neuroendocrine tumor population that's within the phase one, so just that population, where SSTR2 is a sort of definitive marker. For the type of data, it's going to be our dose escalation data for that trial, which is in advanced stage NET patients, and that data would be, of course, our safety data, so this was a high-risk, potential high-return program, because we know that SSTR2, though expressed heavily on the tumors in NET, are also expressed on various healthy neuroendocrine tissues, and we believe there ought to be a therapeutic window that we could design against, and so we're testing that hypothesis now with this CD3 antibody.

Well latest thoughts are that that this molecule. We have now we've we've we're seeing a very promising activity is a highly active agent.

In late line lymphoma deal Tcl.

In particular is the largest population and it's a it's generally well tolerated we have dosing regimen that were nearly done optimizing it. So so we have this kind of agent and it's a very competitive space and we think that it did.

Did the central value proposition for this class is gonna be how you run the clinical development what other agents you combine it with and we think Theres many agents with orthogonal.

Bassil I. Dahiyat: So the type of data would be, of course, safety data, so that's gonna be an important thing to look at. It's going to be what dose we've gotten up to in this population, and of course, any efficacy data and biomarker data that we get from the patients. Note that the standard of care in this tumor type typically has around a 10%-ish response rate, so it's a very low response rate because these tumors don't generally regress. They're usually sort of halted in their tracks, and their functionality is reduced.

Killing mechanism of the tumor cells that that are a great combo approach because as we seen from.

Toxins history.

The real power and breadth of use and moving across all different lines of therapy is because it's been using combination very effectively and I think the tolerability profile and activity profile, we've seen so far as well not a map.

Support that kind of of development effort of course with a much higher level of baseline activities. He was with Rituxan I you know, we don't want to dismiss the potential of monotherapy approaches in particular in niche populations that advance more rapidly and that certainly can be can be value, creating and moving forward but.

Allen S. Yang: Allen, were there any points that I missed about this kind of population?

Allen S. Yang: Yeah, it'll predominantly be the dose escalation cohorts, and we may have some expansion data at the time. But again, not that many patients at this point.

Bassil I. Dahiyat: Yeah, we're talking maybe a couple of dozen.

I think we don't want to be was abandoned that.

Bassil I. Dahiyat: And now you want me to switch to discussing the Atreika collaboration. As for why, I think it's because we have a platform that lets us create antibodies that are really tuned for a particular target in use. We can dial the potencies up or down. We can make it more selective for high-expressing cells than for low-expressing cells, all depending on the nature of the target. The key ingredient for that kind of approach is, of course, really exciting targets. We think finding new targets is an important endeavor. We thought working with one of the best companies out there that can find new target antibody pairs made a lot of strategic sense. That's the rationale.

It's a combination of picture we should be announcing later this year the specific trials that we plan to initiate.

Around combinations as well as well as monotherapy.

And just when could we could we see data.

I'm, sorry, yes, sorry, two questions.

We're not guiding to any data or a specific data read out a yet for promote a map.

We're being mindful of of potential, though they haven't hidden Patrick as much yet cobot impacts and so we'll guide on that a little bit later on and what our next what our next data data disclosures would be.

Bassil I. Dahiyat: We want to take this toolkit we built and apply it against the broadest range of biologies we can get to. There are technologies out there for finding new targets and antibody pairs against them that we don't have. We have to then find the best out there. Were there any technical points on that that you wanted to add, John?

Got it and just the second question could you provide any additional color around the ace observed with AMG four to four and what could potential next steps for the program be thank you.

Right.

I think for the moment, we're going to stick to the Amgen public disclosures. They were eight ease that were very likely CD 38 mediated certainly cdthirty eight targeting with with marketed drugs like dart human Mab as well as numerous development programs have shown that there was a.

John R. Desjarlais: Yeah, I mean, I would just get it...

Operator: https://www.kenhub.com

Operator: I am putting all that story together just so you know.

Operator: and again a way to access NovelTarget.

Operator: All right. Thank you.

Operator: And our next question comes from Jonathan Chen with SBB Lyric. Please go ahead. Hi guys, thanks for taking my questions. First question, what are your latest thoughts on Plomodemab's development strategy and when will we see the next data update from that program?

Pretty characteristic adverse events for targeting Cdthirty eight within antibody.

You know, let him out logic adverse events. That's one would expect so we're not going specifically into the.

A detailed at the end before before for the mostly because we've only recently, but in the last few weeks gotten all the detar data and we're still sifting through it but I think that that you know there. There is as were initially assessing potentially a path forward for that molecule and.

Bassil I. Dahiyat: Well, our latest thoughts are that this molecule we have now, we're seeing very promising activity. It's a highly active agent in late-line lymphoma, DLBCL.

Bassil I. Dahiyat: In particular, the largest population, and it's generally well tolerated. We have a dosing regimen that we're nearly done optimizing. So we have this kind of agent, and it's a very competitive space. And we think that the central value proposition for this class is gonna be how you run the clinical development and what other agents you combine it with. And we think there are many agents with orthogonal killing mechanisms of tumor cells that are a great combination approach. Because, as we've seen from Rituxan's history, the real power and breadth of use and movement across all different lines of therapy is because it's been used in combination very effectively. And I think the tolerability profile and activity profile we've seen so far with Clomodomab, www.kenhub.com. We don't want to dismiss the potential of monotherapy approaches, in particular in niche populations, to advance more rapidly, and that certainly can be value-creating and move you forward. But I think what we don't want to do is abandon that combination approach. And we should be announcing later this year the specific trials that we plan to initiate around combinations as well as monotherapies.

And a way to get 38 targeting with a cdthree.

Killing mechanism advanced.

And there's a wide range of tumor types of course amount a lot of tumor types to express cdthirty eight in addition to myeloma ramped and it's been developing.

Okay.

I'm trying to move on to the next question, so try and I hope that answers. Your question I'm next question from my Goldstein with Mizuho. Please go ahead.

Great. Thanks for taking my questions just a couple and the first is on I sat sit there or something like seven the PD one in Chile for by specific [laughter] little bit about what the you would consider the bar for success for that agent given what we know and.

Probably speaking in the checkpoint feels right now and I'm also curious as he is O. Smith treat your 819 and the perceived advantages of eating up by specific as opposed to awesome to develop and we've already seen with that target T E.

Sure.

For 20, 717, I would say the bar for success depends on what should the two different.

Indication.

Hypes or classes that we're pursuing for example in our expansion cohorts Thursday.

Operator: And just when could we see data at ASH? Oh, I'm sorry. Yeah, sorry. Two questions.

Hosts PD one.

Treated patients in an indication where there's ample PD one Houston approved PD one agent.

Operator: We're not guiding to any specific data readouts yet for Plumotumab. We're being mindful of potential COVID impacts, though they haven't impacted us much yet. And so we'll guide on that a little bit later on what our next data disclosures would be.

And those expansion cohorts and there's the indications where there's no PD one approved and there's there's there's not a lot of PD one use but there's a reason like hospice in particular waikiki like for engagement as well could could boost active <unk>.

Operator: Got it, and just a second question: could you provide any additional color around the edges?

There are different there I think in a post PD one patients generally speaking anything close to a 20% response rate.

Bassil I. Dahiyat: Thank you.

Bassil I. Dahiyat: Right. You know, I think for the moment we're going to stick to Amgen public disclosures. They were AEs that were very likely CD38 mediated, certainly CD38 targeting with both marketed drugs, like dartumimab, as well as numerous development programs have shown that there are pretty characteristic adverse events for targeting CD38 with an antibody, you know, a lot of hematologic adverse events, as one would expect. So we're not going specifically into the details of the AMG-424 program, mostly because we've only recently, But I think that, you know, there is, as we're initially assessing, potentially a path forward for that molecule and a way to get CD38 targeting with a CD3 killing mechanism advanced. And there's a wide range of tumor types, of course, hematologic tumor types that express CD38, in addition to myeloma, where Amgen has been developed. Okay.

And in patients that have failed PD, one therapy and say in non small cell lung or in a melanoma would be would be really great at Alan do you want to comment on both and nothing further on the post PD one.

Sort of people approved indications and then maybe comment on me.

No PD, one approved indications in our Uh huh.

Yes, So I think about who said it's a complicated question Mark I mean, you have to look at the patients and so that data will have to look at very closely you have that just to look at that.

When we present that data, but if you think about melanoma you know many patients are just treated with PD, one and some are treated actually with the combination and depending on what their prior response was you know your expectation for what are the response would be in that refractory population remember the phase one is being conducted in the United States. So all the melanoma and non small cell lung cancer patients.

Operator: I'm going to move on to the next question. Mr. Chang, I hope that answered your question. Our next question is from Mara Goldstein with Mizuho. Please go ahead. Great.

I have seen checkpoint inhibitors now in non small cell lung cancer, you know, you're probably going to use only a PD one, but it's usually given in combination with chemotherapy.

Mara Goldstein: Thanks for taking the questions. Just a couple, and the first is on XNAV20717, the PD-1 CTLA-4 bi-specific. Can you just talk a little bit about what you would consider the bar for success for that agent, given what we know, broadly speaking, in the checkpoint field right now? And I'm also curious as to XNAV30819 and the perceived advantages of using a bi-specific, as opposed to some of the development we've already seen with that target via ADC.

Now for patients, where there have been checkpoint activity and our naive you'd expect a higher response rate, but most of the patients in the phase one have seen prior checkpoint.

Either pembro are both nivo it'd be or PD. Once you feel like for combination and in terms of percentage it will probably be low in this refractory population as a baseline, but again, there's not a lot of good data and I think rather than looking past the percentage as an absolute you probably want to look at individual patients see what they've gotten before.

Bassil I. Dahiyat: Sure. Thank you. Thank you. For 27-1-7, I would say the bar for success depends on which of the two different, um... Indication types or classes that we're pursuing, for example, in our expansion cohorts, there are Post-PD-1 treated patients in an indication where there is ample PD-1 use and approved PD-1 agents in those expansion cohorts, and then there are indications where there's no PD-1 approved, and there's not a lot of PD-1 use, but there's a reasonable hypothesis in particular.

Or what their response was how long it lasted and then see what the response was to this particular ages.

Yeah.

[music].

And then there was also the discussion around non keep in mind approved indications, though [laughter].

Yeah. So I think that depend if you know there there there are a limited number of solid what indications are there is activity. It seems like there's a lot of clinical activity, but you would expect it to be higher depending on any indication.

Bassil I. Dahiyat: In particular,

Operator: I think in the post PD-1 patients, generally speaking, anything close to a 20% response rate in patients that have failed PD-1 therapy in, say, a non-small cell lung or in a melanoma,

You would probably be seek to see cana responses, maybe up to 30% to 50%.

But of course, that's in PD, one that's an indications where PD one therapy is known to work, we're exploring indications where they're not necessarily yes.

Operator: It would be really great.

Allen S. Yang: Allen, do you want to comment on both, anything further on the post PD-1 indications, sort of PD-1 proven indications, and then maybe comment on the no PD-1 approved indications in our...

Yes, that's exactly right, so where it's known to work, but then there's not been treated because these are U.S. patients because there's no indication for that came out in other words, there's a small clinical study that shows activity. But then there are there is not an approval without indication, yet and those patients or repair and ER into the study right now.

Allen S. Yang: Yeah, so I think, as Basil said, it's a complicated question, Mara. I mean, you have to look at the patients, and so that data will have to be looked at very closely, and you'll have that chance to look at it when we present that data. But if you think about melanoma, you know, many patients are just treated with PD-1, and some are actually treated with the combination, and depending on what their prior response was, you know, your expectation for what the response would be in that refractory population. Remember, phase one is being conducted in the United States, so all the melanoma and non-small cell lung cancer patients have already seen checkpoint inhibitors. Now, in non-small cell lung cancer, you know, you're probably going to use only PD-1, but it's usually given in combination with chemotherapy.

Okay.

For.

53.

Argues for that 30 zero three through 819, why a CD three by specific versus an 80 see I think this goes through the two plus one design and the advantages it could have John.

On a touch on that.

Yeah, I mean, you know so first of all you know one of the reason we like the target was because of the data that was generated with the drug contracts. Although you know you probably already figured out that they had you know sort of dose limiting ocular toxicities, you know that stand or class effect with the with the conjugate.

So you know we what we thought that was made the park it looks pretty good.

As to why we would be better you know there's reasons beyond you know not having that sort of plastic toxicity.

Allen S. Yang: Now for patients where there have been checkpoint activity and are naive you'd expect a higher response rate But most of the patients in the phase one have seen prior checkpoint either PEMBRO or both NEVO, IPPE or PD-1 CTLA-4 combination and in terms of Percentage it will probably be low in this refractory population as a baseline but again There's not a lot of good data and I think rather than looking at the percentage as an absolute You probably want to look at individual patients See what they've gotten before what their response was how long it lasted and then see what the response was to this particular

One is that real for carcinoma tends to have more T cells and just about any other solid tumor and so we've got a lot of effector cells to draw from in terms of meeting the activity and then second of all you might imagine you know that other people are talking about this as well as it once you're engaging.

The three T cells some of those you're you're also helping to promote the Dodge is T cell response rate because you're expanding T cells by activating them, you're mobilize exotic highs Akiva claims and so there's there are additional dividends to be to engage in T cells in terms of you know sort of long term activity potentially.

Allen S. Yang: And then there was also the discussion around non-PD-1 approved indications.

Even developing a memory spots against the cancer.

Allen S. Yang: Yeah, so I think that depends. You know, there are a limited number of non-PD-1 indications where there's activity. It seems like there's a lot of clinical activity, but you would expect it to be higher. And depending on the indication, you would probably seek-to-seek responses maybe up to 30 to 50 percent.

[laughter], but if I could just after that point of clarification on.

[laughter].

For.

Yes.

Hey man.

This indication that insight would undertake.

Yes, it's irrelevant to the parties.

Okay. Thank you I really appreciate it.

Allen S. Yang: But, of course, that's in PD-1, that's in indications where PD-1 therapy is known to work. We're exploring indications where it's not necessarily known to work.

Thank you Omar.

And stay safe there in New York.

Thank you.

Thank you. Our next question comes from a third Douglas Guggenheim Securities. Please go ahead.

Allen S. Yang: Yes, that's exactly right, Basil, where it's known to work, but then patients have not been treated because these are U.S. patients because there's no indication for that amount. In other words, there's a small clinical study that shows activity, but then there is not an approval for that indication yet. And those patients are rare into the study right now.

Hey, good afternoon. This is Paul on threats are on thanks for taking my question I guess I have a more specific follow up to the previous question on loading up.

So you know in light up the recent months you'd be approval on have you export potential for combining one judy with limit or not or explode exporting the potential synergies with anti cdnineteen and he'll be field in general.

Operator: Okay, and then for the ANTS-PP3.

John R. Desjarlais: For the 30819Y CD3 Biospecific versus an ADC, I think this goes to this 2 plus 1 design and the advantages it could have. John, maybe you want to touch on that?

And then the second question I'm wondering if you could comment on if there has been sort of any increase conversation or interest in your CD 20 program from a deal perspective on sort of on the heels of the recent Jen Matt on the that'd be agreements. Thanks.

John R. Desjarlais: Yeah, I mean, first of all, one of the reasons we like the target is because of the data that was generated with the drug conjugate, although, you know, you probably already figured out that they had, you know, sort of dose-limiting ocular toxicities than the standard class effect with the conjugate. So, you know, we thought that was made the target look pretty good.

Sure So I'll take that so for the.

I do you have combining a podium address eattwenty three with an anti cdnineteen antibody like my Judy No certainly it's a it's an interesting hypothesis now we're not commenting specifically on any of our combination studies, just yet really that little bit later in the year, but you know in general we believe that you want to have different mechanisms of action for killing tumor cells.

Mara Goldstein: As to why CD3 would be better, there are reasons beyond, you know, not having that sort of class effect toxicity. One is that renal cell carcinoma tends to have more T cells than just about any other solid tumor. And then second of all, you might imagine, you know, other people are talking about this as well, that once you're engaging CD3 T-cells, some of those, you're also helping to promote an endogenous T-cell response, right, because you're expanding T-cells by activating them, and you're mobilizing cytokines and chemokines. And so, you know, there are additional dividends to engaging T-cells in terms of, you know, sort of, long-term activity, potentially even developing a memory response against the cancer.

Working together, we don't really see the need to further boost in in this particular context further boost the T cell function to kill the B cells that promote amount is doing a doing enough of that and some indications with different cdthree antibody you might want to have see a PD one inhibitor that this T cell function now.

What's complimentary to a CD 20, well CD 19 is it different target and you've got different killing mechanism is with saying ADCC driven antibody like my GB. So it's a it's a reasonable hypothesis. You know we also think that there's there's a variety of targeted on small molecule like is it could be really interesting hypotheses, but but it's a it's interesting point your is.

Now regarding CD 20.

Conversations.

Can't.

Mara Goldstein: If I could just ask a point of clarification on the financial arrangement for Manjavi, do you still get payments on those indications that Insight would undertake on its own?

We can't really guide on business development activities, because we believe it has not been activities could ever be predictive perfectly because there's always another party involved I will say that the value of a CD 20, cdthree as as as a very important part of what's going to happen and b cell lymphoma, and potentially as a backbone therapy that.

Bassil I. Dahiyat: Yes, it's irrelevant who the party is.

Mara Goldstein: Okay. Thank you. I really appreciate it.

Operator: Thank you, Mara, and stay safe there in New York.

Paul: Thank you. Our next question comes from Etzer Darout with Guggenheim Security. Please go ahead. Hey, good afternoon. This is Paul on behalf of Etzer.

To be part of displacing protection. After all these years I think that's widely appreciated is what I'll say and you know we think that we could certainly build a lot of value in our program, which we are very excited by the data.

Operator: Thanks for taking our questions. I guess I have a more specific follow-up to the previous question on Flomodomab. So, you know, in light of the recent approval of Monjuvi, have you explored the potential for combining Monjuvi with Flomodomab or explored any potential synergies with anti-CD19 and DLV-CL in general?

Build a lot of value when our program as we continue to advance it on around and further flush out the plans, though that's a program where a partnership might play a complimentary right. Sometimes you do that to expand the scope for scale of development or find good combination partners, but we've got on that when when the time is.

Bassil I. Dahiyat: and Abby Agreement.

Operator: Sure. So I'll take that.

Bassil I. Dahiyat: So for the, uh, for the idea of combining plomodumab or CD20-CD3 with an anti-CD19 antibody like Monjuvi, no, certainly it's an interesting hypothesis. Now, we're not commenting specifically on any of our combination studies just yet. We're going to do that a little bit later in the year, but, you know, in general, we believe that you want different mechanisms of action for killing tumor cells working together. We don't really see the need to further boost, in this particular context, further boost the T-cell function to kill the B-cells. That plomodumab is doing enough of that, and in some indications with different CD3 antibodies, you might want to What's complementary to a CD20? Well, a CD19 is a different target, and you've got different killing mechanisms with, say, an ADCC-driven antibody like Monjuvi. So it's a reasonable hypothesis. We also think that there are a variety of targeted small molecule agents that could be really interesting candidates. But it's an interesting point you raised.

Right when we actually have a deal to announce.

Great. Thanks very much.

Thank you. Our next question comes from Arlinda Lee with Canaccord. Please go ahead.

Hi, Thanks for taking my questions I, maybe just wanted to follow up on flooding that a little bit more and entered the clinic.

Kevin Pietersen can you maybe talk about the scope of the data that you plan to put that whenever you do provide an update and then just.

Well keeping things.

Thank you also previously mentioned expectations for filing and I'd for your ISL G. SIFI you talk about.

Maybe where that program stands right now and then as well ideas on yours CD.

23.

The 14 of our fight the additional.

Phase ones that you're thinking about thing.

Sure. So maybe the easy when the short answer first probably I'd fail to see that's that's on track it looks like it's gonna be very early in the new year.

So that's moving forward, that's our aisle to engineer to be selective to activate regulatory T cells for potential use in auto immune diseases. So it's not an oncology program.

Bassil I. Dahiyat: Now, regarding CD20 deal conversations, we can't really guide you on business development activities because we believe business development activities can never be predicted perfectly because there's always another party involved. And we think that we could certainly build a lot of value in our program, which we are very excited about the data, build a lot of value in our program as we continue to advance it on our own and further flesh out the plans, though that's a program where a partnership might play a complementary role. And sometimes you do that to expand the scope or scale of development or find good combination partners. But we'll guide you on that when the time is right when we actually have a deal to announce.

But it really really exciting molecule design, four plus modem and.

The sort of scope of data that we would want to have it. Our next data released would be really the completion of the phase one the establishment of our our dosing regimen and schedule.

For going forward and of course, whatever efficacy data continues to flow out of that that phase one would be what we would want to want to show.

World.

So and of course, you know the plans for what we were going to do that can come before along with that that data. There's sort of we're always working very hard to get everything pulled together for your next stage clinical trials as your wrapping up the ones you're working on.

Paul: Great, thanks very much. Thank you. Our next question comes from Arlinda Lee with Con-Accord. Please go ahead. Hi guys.

Now for the CD 123 additional phase one you know what you were sort of getting out what ideas would you have.

Operator: Thanks for taking my questions. I maybe just wanted to follow up on Float and Bab a little bit more. In terms of clinic, in 2017, can you maybe talk about the scope of the data that you plan to present whenever you do provide an update? And then just some housekeeping things. I think you also previously mentioned expectations for filing an IMD for your IL-2 FC. Can you talk about that? https://www.kenhub.com The additional Phase 1's that you're thinking about.

On that is what you're saying, so I would say.

There's there's different slices of.

Hey, a mel and I think a in particular, if look at how to landscape in AML Shacey I think the biggest changed there is the emergence of genetic KLAX has an agent both in in front line into sort of elderly frail population as an induction therapy and then of course, it's gonna start if you can use more and more than relapse setting.

Bassil I. Dahiyat: Sure, so maybe the easy one, the short answer first: file the ID for the L2FC. That's on track. It looks like it's going to be very early in the new year.

It's gonna have a label there soon probably so we want to make sure. We're mindful of that and I think that there's different places where a highly active T cell engaging in light of at least the cells can be use and using that in and in the context of.

Bassil I. Dahiyat: So, that's moving forward. That's our IL-2 engineered to be selective to activate regulatory T cells for potential use in autoimmune diseases, so it's not an oncology program, but a really exciting molecule design. The scope of data that we would want to have at our next data release would be really the completion of Phase I, the establishment of our dosing regimen and schedule for going forward. And, of course, whatever efficacy data continues to flow out of that, that Phase I would be what we would want to show; the plans for what we're going to do with it can come before or along with that data. You're always working very hard to get everything pulled together for your next stage of clinical trials as you wrap up the ones you're working on.

Whether its consolidation or whether it's in the right relapse setting is is where we're looking somebody else will specify more on that later when we can we are in partnership with Novartis. There we have to be.

And we have to be mindful of of disclosure requirements.

That that it's your question Linda.

Very much yes.

Q.

Thank you aren't next question comes from Gregory rent that with RBC capital markets. Please go ahead.

Hi, This is an English bank so Greg Thanks for taking my question. My first question as a follow up on to the clean up question and G four too far.

Bassil I. Dahiyat: Now for the CD123 additional phase 1, you were sort of getting at what ideas you would have on that, is that what you're saying. So I would say there are different slices of AML, and I think in particular we have to look at how the landscape in AML is changing. I think the biggest change there is the emergence of venetoclax as an agent both in front line in the sort of elderly frail population as an induction therapy, and then, of course, it's going to start, it's being used more and more in the relapse setting, and I think it's going to have a label there soon, probably. So we want to make sure we're mindful of that, and I think that there are But again, we'll specify more on that later when we can. We are in partnership with Novartis there. And we have to be mindful of disclosure requirements. Does that answer your question, Orlinda?

How should we think about sometimes you read through from the discontinuation to the development of Angie.

Thank you.

I don't think there is any read through the the as Amgen disclosed the toxicities were very likely CD 38 mediated.

If you kill Cdthirty positive sell things happen.

It their conclusion from the review of the data and then are we agree from our initial review of all the phase one data is that that's quite likely what the case wasn't so.

T 38 media toxicity does not read through to the 85 and I'm program, which of course is targeting of prostate cancer antigen did not appear to be something fundamental about CD three targeting.

In general or for our constructs or ex snap bi specifics in general at all to be read through for the AMC 44 AG data.

Right and can't just one more follow me if I may on when you talk about how your strategy for solar masses evolved and what are your latest thinking is around the future of this program. Thank you.

Right so.

We have not we're not.

Investing in its in for the development internally, we have been continuing to analyze the data from our lupus phase two trial, which had a very very robust and really cutting edge biomarker strategy around it and we do expect to be disclosing some information around the biomarker work, we've done there, which we should be able to talk about in the next couple of months.

Orlinda: Thanks very much. Yes.

Bassil I. Dahiyat: Thank you.

Operator: Thank you. Our next question comes from Gregory Renza with RBC Capital Markets. Please go ahead. Hi, this is Xinyue Lu bearing on for Greg.

Xinyue Lu: Thank you for taking my question. My first question is a follow-up to the previous question on AMG 424. How should we think about the potential read-through from the discontinuation to the development of AMG 509? Thank you.

I believe and I think that does bear on the strategy for the molecule, though again, we're still committing to.

Bassil I. Dahiyat: I don't think there is any read-through. As Amgen disclosed, the toxicities were very likely CD38-mediated. If you kill CD38-positive cells, things happen. Their conclusion from the review of the data, and we agree from our initial review of all the Phase I data, is that that's quite likely what happened. CD38-mediated toxicity does not read through to the AMG509 program, which of course is targeting a prostate cancer antigen. There did not appear to be anything fundamental about CD3 targeting in general or R constructs or XMAP biospecifics in general at all to be read through from the AMG424 AE data.

Developing an external says anymore.

Got it. Thank you again for taking my question. Thank you.

Thank you. Our next question comes from Tom Shrader with BP I Gene. Please go ahead.

[laughter] a good afternoon I had a question about the timeline of via Trico deal I mean, I agree it's a pretty exciting screen to match with your format. Because this is true discovery deal or is it a tree 'cause antibodies that they've already discovered and you're just constructing antibodies could we see something pretty quick here or is it.

Is it sort of back to square one for their screening approach.

Xinyue Lu: Great, thank you. Just one more from me, if I may. Can you talk about how your strategy for OBEC Solimab has evolved and what your latest thinking is about the future of this program? Thank you.

I would say.

It's really about.

Using the fruits of their their screening work. That's that's created antibodies, where there's some functionality around them, but of course, there always updating that and adding new so so though at the discovery program of course, you're not going have anything into the clinic in a couple of years, but I think this is about.

Bassil I. Dahiyat: Right, um, so... Though we are not investing in further development internally, we have been continuing to analyze the data from our lupus phase II trial, which had a very, very robust and really cutting-edge biomarker strategy around it. And we do expect to be disclosing some information around the biomarker work we've done there, which we should be able to talk about in the next couple of months, I believe. And I think that does bear on the strategy for the molecule, though, again, we are still committing to developing it external to Xencor.

Exploiting all the great foundational work they've done while they continue to add to it John do you want to add anything on that.

No that's about right I mean, there you know there there they're coming to the table with with an existing basket of antibodies, but they're certainly not slowing down their ongoing discovery activities. So there's you know that though the well could be replenished as we go through the collaboration.

Xinyue Lu: Got it. Thank you again for taking my questions.

Operator: Thank you.

Operator: Thank you. The next question comes from Tom Schrader with BTN.

And there could have tremendous we bring it to be able to rapidly make drug candidate quality molecules, where you can test how that antibody works and see a cdthree by specific context, and then if it works you immediately after the races in development.

Tom Schrader: I asked a question about the timeline of the Atreika deal. I agree it's a pretty exciting screen to match with your format. Is this a true discovery deal, or is it Atreika's antibodies that they've already discovered and you're just constructing antibodies? Could we see something pretty quick here, or is it sort of back to square one for their screening approach?

Great and then I had a quick remedial question on the two plus one format or.

Is there any sense on how powerful but is I mean, I know a regular antibody a tiny fraction actually goes to the target three cents on how much better. This isn't there is anybodys imaging data that we can look at an i. I think we only have one example.

Bassil I. Dahiyat: I would say it's really about using the fruits of their screening work that's created antibodies where there's some functionality around them, but of course, they're always updating that and adding new ones. So as a discovery program, of course, you're not going to have anything in the clinic in a couple of years, but I think this is about exploiting all the great foundational work they've done while they continue to add to it. John, do you want to add anything to that?

Where the format was compared to a conventional format isn't that right. The Roche CD 20 case, where really all that happened as talks got worse.

Well I think that molecule still has interesting promise, but remember of course I don't know about a direct comparison, but Roche also had a C. A so called.

John R. Desjarlais: No, that's about right. I mean, you know, they're coming to the table with an existing basket of antibodies, but they're certainly not slowing down their ongoing discovery activities. So there's, you know, the well could be replenished as we go through the collaboration.

Colorectal cancer target.

Antigen in that kind of format with a cdthree by specific and you know they Saab promise activity really late lend population. So.

Tom Schrader: And the benefit we bring is being able to rapidly make... These are drug candidate quality molecules where you can test how that antibody works in, say, a CD3 context, and then if it works, you're immediately off to the races in development.

So.

<unk> direct comparison, John do you want to touch on where the real power is whether it's in better a video or better selectivity.

Yeah, I mean as you know there just is to to to go through the concept again the ideas, particularly in the solid tumor setting where you can't you're not like you know and he mark.

Bassil I. Dahiyat: Great. And then I had a quick remedial question on the 2 plus 1 format. Is there any sense of how powerful that is? I mean, I know a regular antibody, a tiny fraction, actually goes to the target. Is there a sense of how much better this is? Is there anybody's imaging data that we could look at? And I think we only have one example where the format was compared to a conventional format. Isn't that right? The Rho CD20 case where

You know you target b cells at it turns out that people can couldnt blip better than we ever thought they could without any b cells right. So you could you can tell killed not only the malignant b cells, but the cell of origin as well and the patients just fine the solid tumor setting that's probably not going to be the case for lot of these targets right. Because there's there are expressed on.

Operator: Really, all that happened is...

Operator: www.youtube.com.uk So, direct comparison. John, do you want to touch on where the real power is, whether it's in better avidity or better selectivity?

On the important orders and so this is really about just try to expand the therapeutic index between you know attacking tumor cells versus I guess attacking normal cells.

You know, but you know that to about one point about the see a you know that the two plus 100 Roche's had you know that they sort of led the way on this a you know we've been working on this concept for a while now a there's been some nice preclinical publications on the Gen Tech group in the context of her to that really pretty nicely you know Lee.

John R. Desjarlais: Yeah, I mean, just to go through the concept again, the idea is particularly in the solid humor setting where, you know, you can't, you're not, like, you know, in He-Monk. You target B-cells, and it turns out that people can live better than we ever thought they could without any B-cells, right? So you can kill not only the malignant B-cells but the cell of origin as well, and the patient's just fine. In a solid tumor setting, that's probably not going to be the case for a lot of these targets, right? Because they're expressed in important organs.

The concept you know with a lot of different comparative studies.

So we do think there was a lot of promise for this this format.

Okay. Thank you.

Thanks, Tom.

Thank you. Our next question comes from Peter Lawson with Barclays.

John R. Desjarlais: And so this is really about just trying to expand the therapeutic index..... But, you know, to Basil's point about the CEA, you know, the two plus one in Roshan's hands, you know, they sort of led the way on this. You know, we've been working on this concept for a while now. There have been some nice preclinical publications from the Genentech group in the context of HER2.

Thanks.

Peter.

Are there.

Next I can find drops are well then minimal phones in the next question from Dane Leone with Raymond James. Please go ahead.

Hi, Thanks for the update and taking the questions I just wanted to get a sense of the timeline that you might understand on.

John R. Desjarlais: That really pretty nicely lays out the concept, you know, with a lot of different comparative studies. So we do think there is a lot of promise for this format. Okay, thank you.

Seeing data for two for three or six.

Right. So genetic is executing the clinical trial for X map to for three or six which is our I'll 15 molecule for oncology.

Peter Richard Lawson: Thank you. The next question comes from Peter Lawson with Barclays.

They started the phase one study in Q1 of this year I think given.

Operator: Thank you.

Dane Vincent Leone: It looks like his line drops are moving. I'm going to move on to the next question from Dane Leone with Raymond James. Please go ahead.

Yes.

Where that the study is you know advancing dose escalation as well as genentech, we have to agree with them on a data disclosure. So they have the rights to win.

Bassil I. Dahiyat: Alright, thanks for the update and taking the questions. I just wanted to get a sense of the timeline that you might understand on seeing data for 24306.

We do you know so we have to both both be insync on that I I think it's unlikely we'll have any data this year for sure and as to whether next year.

Bassil I. Dahiyat: Right, so Genentech is executing the clinical trial for XMAP24306, which is our IL-15 molecule for oncology. They started the Phase 1 study in Q1 of this year. Where the study is advancing in dose escalation, as well as Genentech, we have to agree with them on data disclosure, so they have the right to say when, as well as we do, so we have to both be in sync on that. I think it's unlikely we'll have any data this year, for sure, and as to whether next year... We'll have to confer with Genentech later in the year. So we really can't give you anything more specific than that, unfortunately.

We'll have to it will have ticket for with Genentech later in the year.

So we really can't give you any anything more specific from that unfortunately.

Pure remind us how the economics of the partnership for sure of course, we signed a deal in February of 2019. It is a 50, 545% were 45% Xencor worldwide split of the profit and loss and we had 120 million upfront paid and there's 160 million in clinical stage milestone.

For the lead program to for three or six.

And so in addition to splitting all development costs and and then splitting up the P. and now 50, 545, Genentech will pay 100% of all what are called launch costs. So pre approval commercialization preparation activities.

Dane Vincent Leone: Can you remind us how the economics of the partnership work?

Bassil I. Dahiyat: Sure, of course. We signed a deal in February of 2019. It is a 55-45%, where 45% of Xencor worldwide splits the profit and loss. We had $120 million up front paid, and there's $160 million in clinical stage milestones for the lead program, 24306. And so, in addition to splitting all development costs and then splitting the P&L, 55-45, Genentech will pay 100% of all what are called launch costs, so pre-approval commercialization preparation action, www.youtube.com.uk. We also have the right to run combination studies with 24306 and both internal Xencor pipeline candidates as well as drug molecules of third parties as long as they don't directly compete with molecules in the collaboration. It'll boost the T cells and boost the NK cells for other therapies, actually. OK.

An important noneconomic part of that deal and so in addition to having a very large stake in the ultimate value with the asset.

We also have a the rights to run combination studies with two for three or six and and both internal Xencor pipeline candidates as well if candidates are molecules a drug molecules of third parties as long as they don't directly compete with molecules in the collaboration because combination is is where I Nile 15.

It is gonna be used it will place the T cells to see NK cells for for other therapies action.

Okay mix, that's how it sounds just one more question maybe a macro question for you.

As you have a lot of assets in the portfolio and and kinda early stage development.

You can kind of is there a way to give us a sense of maybe over the next 12 months.

Dane Vincent Leone: Makes a ton of sense. Just one more question, maybe a macro question for you. As you have a lot of assets in the portfolio and are kind of in early stage development, do you, can you kind of, is there a way to give us a sense of maybe over the next 12 months? You know how many of those uh programs you would want to nominate into more later stage phases?

You know how many of those.

Programs, even want to to nominate into more later stage phase two testing or how you want to approach later stage development for some of these assets.

And just kind of understanding how you internally expects that the programs to advance as we head into 2021.

Operator: Thank you all for joining us today.

Bassil I. Dahiyat: Yes, so over the next 12 months, hopefully, we'll have more data we can talk about publicly around XNAP20717, the PD-1 CTLA-4 inhibitor in both these, our expansion cohorts of both sort of PD-1 experienced solid tumors as well as sort of non-PD-1 approved solid tumor indications. And that should help guide us on more specifics of do we go in one basket of indications, say post PD-1, do we go in the non-post PD-1, do we go in either, do we go in both. Data will have to drive it. So I think we should have more clarity on how that program is going to be able to proceed. And I think that as we provide the specifics, as our plans are really coming together around Plomodomab and the CD20-CD3, we should also be able to provide significant clarity there for how we're thinking of the later stage.

Yes, so so over the next 12 months hopefully we'll have more data we can talk about publicly around X nephews, you're a 717 to PD ones utility for inhibitor across.

These are expansion cohorts of both sort of p. when experienced solid tumors as well sort of a non PD one approved cell tumor indications.

And.

That should help guide us on on more specifics of do we go in and one basket of indications. They post p. when do we go in the non PD one to be going either to become a in both data will have to drive us I think we should have more clarity there how that program is gonna have to it's gonna be able to proceed and I think that as we provide the specifics as our plans or.

Really coming together around promote a map into CD 20 cdthree.

That also should we should go with pride significant clarity there.

For how we're thinking of later stage I think in that case, we feel very comfortable that the data we have already.

Bassil I. Dahiyat: I think in that case, we feel very comfortable that the data we have already strongly supports moving forward, at least in DLBCL. And as we continue the studies and do more work, we can hopefully bring other indications forward in a data-based way. I think those are the ones I think that we should have more clarity on, and the others we're going to continue to generate further data.

Strongly supports moving forward at least in in the L. Bcl and and as we continue to studies and do more work. We hopefully can bring other indications forward in a database away I think those are the ones I think though that we should have more clarity on the others were going to continue to to generate a to generate further.

Data.

Okay, great. Thank you very much hey, thank you Dan.

Dane Vincent Leone: Okay, great. Thank you very much.

Operator: Hey, thank you, Dane.

Zhiqiang Shu: Thank you. And as a reminder, ladies and gentlemen, if you have a question, just press star then 1 to get in the queue. Our next question is from Zhiqiang Shu with Berenberg. Please go ahead. Hi, good afternoon. Thank you for taking my questions. I have a few here.

[noise] NFL reminder, ladies and gentlemen, Navy I've a question just press Star then one to get into Kim.

Our next question is from she can choose Bamberg. Please go ahead.

Hi, Good afternoon. Thank you for taking my questions Ive a few here first is on the STR two for when that I'm, just I guess can you overview with the treatment landscape, particularly.

Bassil I. Dahiyat: First, is on the SSPR-2 for NET. I guess, can you outline the treatment landscape, particularly related to Luthera, and do you think your program needs to be Lutheran to be competitive or to be approved? And then also on that program, what are the safety signals you are mostly concerned about? And then secondly, on the IL-2 program, I know it's early in the day, but I guess do you guys have an idea what indications you are potentially pursuing? And then, are you looking for a partner for this program? Thank you.

Related to the era.

And do you think the.

Your program used to be look there are to be competitive or to be approved and then also on that program. What are the safety signals you're are you mostly concerned about.

And then secondly on the Io two program I know, it's early in the days, but I guess do you guys had an idea what indications you or potentially pursuing.

And then are you looking for partner for this program.

Yeah.

Bassil I. Dahiyat: So I have got four questions. Let's make sure we can run through them.

Thank you so I got four questions, let's make sure I can run through it we can run through them.

Bassil I. Dahiyat: For SSTR2, Lutathera, how does that play in a competitive context? We have... We clearly are seeing patients that are non-post lutethera, even though lutethera is indicated for them. So, not everybody gets radiotherapy. The obvious distribution issues with radioisotope... The safety signals we will be looking for, looking for ones where we know SSTR2 is expressed, gastric tissues expressed in pancreatic islet cells expressed in some lungs; we're going to look at all of those. Now, for IL-2, we're not ready to guide on indications, and we are an oncology-focused company, so I think we'll be willing to entertain partnerships earlier for IL-2, but we are prepared to move it forward to get to meaningful inflections, even post-biomarker for Phase I data.

Breath of tier two Luna Thera, how does that play in a competitive context.

We have.

We clearly are seeing patients that are that are non post Louis area. Even alluded. There is indicated for them. So not everybody gets a radiotherapy dobbies distribution issues video isotopes or are clear into the safety signals, where we will be looking for looking for ones, where we know STR. Two is expressed here, there's expect gastric tissues expressed in pancreatic islet.

Cells expressing some lung so we're going to look at all those.

Now for aisle to we're not ready to guide on indications and we.

We are in oncology focused company. So I think we'll be willing to entertain partnerships earlier for the I'll too, but we are prepared to moving forward.

Tickets, a meaningful inflections, even post biomarker phase one data.

Okay, and and then do you also have higher too far out of that phone college in the works to or no. We do not I'll 15 program. We believe is a better starting point. We believe we have a very attractive hopefully best in class product profile for the team, which of course engages aisle to beta gamma receptors downstream, but.

Zhiqiang Shu: Okay, and then, do you also have an IL-2 for oncology in the works, too, or not?

Bassil I. Dahiyat: No, we do not. Our IL-15 program, we believe, is a better starting point. We believe we have a very attractive, hopefully best-in-class product profile for our IL-15, which, of course, engages IL-2 beta gamma receptors downstream but completely avoids the CD25 binding that you usually have to work to get rid of for IL-2. So, no.

Wheatley avoids the CD 25, finding that usually have to work to get rid of royalties. So no.

Okay, great. Thank you for so the question. Thank you congrats on the progress.

Zhiqiang Shu: Okay, great. Thank you for the questions.

Bassil I. Dahiyat: for the questions. Thank you.

Thank you and I last question, calling some Peter Lawson with Barclays. Please go ahead here.

Operator: Thank you. And our last question comes from Peter Lawson with Barclays. Please go ahead.

Peter Richard Lawson: Hi Basil, thank you. Just on CD20 and CD3, that's a crowded but really exciting landscape. How should we think about your position there? Is it moving into combos or different indications, or do you think it's a question of driving up efficacy?

Hi, that's it. Thank you I'm back just some cdtwenty cdthree [laughter] crowded, but really cutting on just how should we think about your positioning there is limited to combos old communication. So what do you think it's a question is driving up advocacy.

Bassil I. Dahiyat: I think it's about combinations. I think from the efficacy data we have and that we see with our competitors, like Roche and Regeneron, I think we have a pretty good feel for where the efficacy falls for this class, and I think there's a lot of commonality there. And I think it's going to be about working in the right combinations, and of course, if you see a signal as you explore your various indications that you get coming into your trial where a CD20, or CD23 might work, we're all discovering that. And what niches these particular mechanisms actually might best suit will, of course, chase that signal very rapidly. So I think there's certainly potential opportunities here. Around indications or slices, where we learn things, we can maybe get the jump on competitors. But I think the focus right now is how you best combine and best position yourself, both in this relapsed refractory setting and then, ultimately, want to move into an earlier line. It's going to be about that more than anything.

Oh, no I think it's about it's about combinations I think from the efficacy data, we haven't we see with our our competitors like Roshe Regeneron.

We have a pretty good feel for the efficacy falls for this class and and I think there's there's there's a lot of commonality there and I think it's going to be about working in the right combinations and of course, if you see signal as you explore in in your in your various indications that you get coming into your trial, whereas.

20, Cdthree might work you know we're all discovering.

What niches. These <unk>. These particular mechanisms actually my best suits will of course chase that signal very rapidly. So I think there's there's an opera, there's certainly potential opportunities around.

Around indications are slices, whereas we we learn things we can maybe get the jump on competitors, but I think the focus right. Now is how do you best combined and best position yourself. Both in this this relapse refractory setting and then ultimately want to move into into earlier lines, it's going to be about about I think that more than anything.

Peter Richard Lawson: And when do you think we can have kind of a complete picture around that? When are you going to roll out the strategy?

No I wouldn't be anything we could have kind of a complete picture around that when when you're going to rollout strategy.

Well, we still we still expect to be able to give a lot for the guidance on our strategy later this year.

Bassil I. Dahiyat: We still expect to be able to give a lot further guidance on our strategy later this year.

Peter Richard Lawson: Thank you. And then just on CTLA-4 PD-1, when should we see the next data, and is that patient...

Thank you and then just on the CP like for PD, one when should we see the next day tour and you said that patients did in Seattle.

Sure so for potentially for PD one within the next 12 months, we should have at least a.

Bassil I. Dahiyat: Bye.

Peter Richard Lawson: Sure. So for CTLA-4 PD-1, within the next 12 months, we should have at least an initial bolus of data out of our expansion cohorts. Of course, there are five cohorts, so we can't get all of them done at once, but we should have that initial bolus of data coming out within the next 12 months. And I'll defer the question on whether the patient has come off a study for investigator of choice.

An initial bolus of data out of our expansion cohorts of course are five cohorts. So can't get all of them done at once but we should have that initial a bolus of data coming out within the next 12 months and all the for the question on the CR patient or do we have any I'll ask Alan do we have definitive knowledge about that patient anymore.

They've now that they've.

Gone too far out no the patients come off the study for investigator choice and.

Allen S. Yang: Patient decision, and so we know that they were in CR at the time of coming off study, but we don't have additional data from that patient.

Based decision and so we know that they were NCR at the time of coming off study, but we don't have additional data.

Ration.

Peter Richard Lawson: Great. Okay. Thanks.

Okay. Thanks, much thanks for the additional occur.

Bassil I. Dahiyat: Thank you so much. Thank you for the additional time. Thank you, ladies and gentlemen. This concludes our Q&A session. I would like to turn the call back to Basil Dahiyat for his final remarks.

Thank you.

In Q1 neighborhood gentlemen, this concludes our killing me Sachin I will like to turned a cold back to Bassil Dahiyat for his final remarks.

Bassil I. Dahiyat: Great. Thank you very much, Operator. And thank you, everybody, for joining us today. We hope our friends and colleagues on the East Coast and in New York are keeping safe from the tropical storm and that everybody takes care of themselves during the COVID pandemic. Have a great evening, and look forward to updating you again in the future. Bye-bye.

Great. Thank you very much operator, thank you everybody for joining us today, we hope our friends and colleagues on the East coast sit in New York or keeping safe from the tropical storm and that everybody.

Takes care of themselves and the cobot pandemic.

Have a great evening and look forward to appeal.

Sure.

Operator: And with that, ladies and gentlemen, we thank you for participating in today's conference. You may now disconnect. Have a wonderful day.

And with that ladies and gentlemen, we thank you for participating in today's conference. You may now disconnect have a wonderful day.

Operator: BF-WATCH TV 2021

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