Q1 2020 Earnings Call
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Operator: Ladies and gentlemen, today's conference is scheduled to begin shortly. Please continue to stand by, and thank you for your patience. Again, today's conference is scheduled to begin shortly. Please continue to stand by, and thank you for your patience.
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Operator: Ladies and gentlemen, thank you for standing by, and welcome to the first quarter 2020 Xencor conference call. At this time, all lines are in a listen-only mode.
Operator: After the speaker's presentation, there will be a question-and-answer session. And to ask a question during the session, you need to press star 1 on your telephone. Please be advised that today's conference is being recorded, and if you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Charles Liles. Thank you, and please go ahead, sir. Thank you, and good
Charles Liles: Earlier this afternoon, we issued a press release which 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. Our Portfolio Programs and Licensing Partnerships John Kuch, Senior Vice President and Chief Financial Officer, will review the financial results from the first quarter. Then we will open up the call for your questions, and Allen Yang, Senior Vice President and Chief Medical Officer, will join us for the Q&A. 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.
[music], ladies and gentlemen, thank you for standing by and open to the first quarter 2020, Sincor Conference call.
Charles Liles: 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 factor sections of our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q.
At this time, all participants lazanda listen only mode. The speakers presentation. There will be a question and answer session to ask a question during the second we need to press star one of your telephone.
Please be advised the today's conference is being recorded mix require any further since you. Please press star zero.
I like Darren conference over to your Speaker trick Charles Laos. Thank you Maam. Please go ahead Sir.
Bassil I. Dahiyat: With that said, let me pass the call over to Basil.
Thank you and good afternoon.
Bassil I. Dahiyat: Basil, I believe we're we.
Earlier. This afternoon, we issued a press release, which outlines the topics we plan to discuss today. The press releases available at Www Dot 10 core dot com.
Bassil I. Dahiyat: Oh, sorry, you know what? I believe I was on mute.
Bassil I. Dahiyat: I'm very sorry to all of you listening. That's a very COVID-19 kind of screw-up. So I'll start again. Good afternoon.
Bassil I. Dahiyat: Before we touch on the development portfolio update, I'm going to describe the effects of the COVID-19 pandemic on our business. Now, despite the numerous challenges, we're fortunate that our clinical trials and research work continue to progress, with a modest impact on trial enrollment to date, and that we continue to enjoy a strong cash position. We're still enrolling patients into a number of clinical studies that are evaluating our biospecific antibodies and oncology. And while clinical studies in oncology are still a high priority for patients, their families, and their physicians, the planned study initiation is later this year for our two hematology programs, Plenodemab, our CD20-CD3 program, and Vibocodemab, our CD123-Bi-CD And enrollment in our ongoing studies will likely be affected, as many clinical sites have delayed starting new trials and others have postponed enrollment. The situation is very fluid, and we'll continue to update as... Within the company, we've implemented a number of measures to protect the health and safety of our employees and our community. These include requiring all non-laboratory employees to work remotely, reducing research lab staff density by implementing alternating shifts, and by reorganizing our facility to further reduce staff.
They are call that's all that yet president and Chief Executive Officer will provide updates regarding cobot 19.
Full year programs in licensing partnerships, John Cushe, Senior Vice President and Chief Financial Officer, or do the financial results from the first quarter. Then we'll open up the call for your question Alan Yang Senior Vice President and Chief Medical Officer will join us for the QNX.
Before we begin I would like to remind you that during the course of this conference call. Then core management may make forward looking statements, including statements regarding the company's future financial and operating results future market condition, the plans and objectives of management for future operations, the company's partnering efforts capital requirement future product offerings research.
In development programs.
Pat I'd be cobot 19 pandemic on these topics before because they are not historical facts, rather are based on our current expectations and beliefs and are based on information currently available.
Bassil I. Dahiyat: Now, a core part of our business is to complement our internal pipeline development with partnering, and we've received payments from the licensing of our XMAP technologies, the clinical advancement of XMAP candidates, as well as royalties from sales of approved products. We're monitoring for potential impacts from this partnership.
The outcome of your best describe any forward looking statements are subject to know none risks uncertainties and other factors that could cause actual results could differ materially from their results anticipated by these forward looking statements, including but not limited to those factors contained in the risk factor section of our most recently filed annual report on form 10-K in quarterly report on form 10-Q with that.
Bassil I. Dahiyat: On the other hand, in April, our partners Lexion and VeeR Biotechnology each announced plans to initiate clinical studies evaluating antibodies that incorporate our Xtend FC technology to treat patients with COVID-19. Lexion announced that they're initiating a phase 3 trial with ultramuricine treating patients with severe COVID-19 symptoms. And VeeR, under our expanded partnership to include antibodies targeting the SARS-CoV-2 virus, announced plans to initiate a phase 2 study with such an antibody drug. Partnerships like these certainly highlight the plug-and-play nature of the suite of XNAB-FC domains we've created, which have small changes in their structure that we designed and allow us and our partners to engineer nearly any antibody to have improved activity, longer half-life, or bispecific structure. This flexibility and portability enable us to take multiple shots on goal simultaneously and generate proof-of-concept data to guide which programs we will independently advance, partner with, or terminate.
Let me pass the call overcapacity.
That's all I believe were we we think you're on mute.
Oh, sorry, you know what I believe I was on new I'm very sorry to all the listening.
That's a great kobin 19 kind of screw up.
So I'll start again, good afternoon, and before we touch on the development portfolio update I'm going to I'm going to describe the effects of cobot 19 pandemic on our business now despite the numerous challenges we're fortunate that our clinical trials and research work continue to progress modest impact on trial enrolled to date and if we can see.
You do enjoy strong cash position, we're still enrolling patients into a number of clinical studies that are evaluating our bi specific antibodies oncology.
Bassil I. Dahiyat: We're focusing our R&D on the expansion and use of our XMAB by specific platform to create drug candidates that find two or more different targets simultaneously, and we're currently running six phase one clinical studies evaluating XMAB biospecifics. A plug-and-play approach to engineering enables the rapid design and simplified development of antibodies and other protein structures like cytokines. Bi-specific Antibodies and Cytokines are a rapidly emerging area of therapeutic development, particularly in oncology, and in order to stay at the forefront of innovation in this space, we use our engineered heterodimeric FC domain as a robust scaffold to rapidly develop new candidates that we group into three classes: T cell engagers, tumor microenvironment activators, and cytokines. The first and most advanced class are the T-cell engagers.
The wall clinical studies on called you're still hungry for patients their families. In addition.
The plan study initiation later this year for actually hematology programs, although demand RCD 20, Cdthree program and by the code AMAP RCD 123, like Cdthree program.
Andy enrollment to our ongoing studies will likely be affected as many clinical sites have delayed starting new trials and others that that's going to moment situation is very fluid and we'll continue to update as appropriate.
Within the company, we've implemented a number of measures to check the health and safety of our employees in our community. These include requiring gone all laboratory employees work remotely a reduction of research lab staff density by implementing alternating shift in viral and by reorganizing our facility to further reduce step downs.
No corporate of our business is to complement our internal pipeline development with partners and we receive payments from the licensing were actually up technologies. The clinical advancement, that's not candidates as well as royalties from Shelton group products, we're monitoring for potential impacts this partnership.
Well the other hand in April our partners Lexsi on into your biotechnology, each announced plans to initiate clinical studies evaluating antibodies.
Bassil I. Dahiyat: These are tumor-targeted bispecific antibodies that contain both the tumor antigen binding domain and a cytotoxic T-cell binding domain, specifically a CD3 binding domain. These T-cell engagers, which we also call CD3 bispecifics, activate T-cells at the site of the tumor in order to potently kill malignant... Before we review these programs, please note that our first three CD3 bi-specific programs, those targeting CD123, CD20, and somatostatin receptor 2, have recently received their non-tripartite names, Vibocodumab, Plamodumab, So Vibocodumab is XMAB14045, Plamodumab is XMAB13676, and Tidudumab is XMAB18087. Now, while we continue to dose patients in our Phase 1 studies of ibucodumab and pomodumab and hematocytes...
Corporate or extend FC technology to treat patients covered 90, what feeling announced that they are initiating a phase three trial with built in years and treating patients with severe cut the Nike symptoms.
And here under expanded partnerships include antibodies targeting the stars could be two virus announced plans to initiate a phase two study with such an antibody drug candidate.
The partnerships like the certainly highlight the plug and play nature of the suite. It backs now that you've means we've created which have small changes in their structure that we designed and allow us and our partners to engineer nearly any antibody to have improved activity longer half life or by specific structure.
This flexibility import ability to enable us to take multiple shots on goal simultaneously generate concept you did guide, which programs will independently advance will partner or Germany.
We're focusing our R&D on the expansion each of our ex not by specific platform to create drug candidates with like two or more different targets simultaneously.
Currently running six phase one clinical studies evaluating ex now but specific antibody.
Bassil I. Dahiyat: We plan to initiate additional studies of these programs subject to possible impacts from the COVID-19 pandemic, as I mentioned earlier. We also continue to dose patients in the Phase I study of Tidudumab and continue to expect that we will present initial data from this ongoing study in neuroendocrine tumors and gastrointestinal stromal tumors in the second half of. In addition, we've expanded our CD3 class of bispecifics by developing our XMAP 2 plus 1 bispecific format. It uses the same heterodimeric XMAP-FC domain as our other bispecific antibodies and cytokines but has two identical tumor targeting domains and one CD3 targeting domain. The two tumor targeting binding domains can bind together when there is more of a target present, a property called avidity.
Plug and play approach engineering enable rapid design and simplified development of antibodies and other person structures like cytokine.
Much of the kinda bodies and cytokines are rapidly emerging area of therapeutic development, particularly in oncology.
We're just at the forefront of innovation in the space.
We use our engineered heterodyne or a kept feed to me as robust scaffold rapidly develop new candidates that we grew up into three classes T cell engagers tumor microenvironment activators inside.
First the most advanced classes. The T cell Engagers. These are two were targeted by specific antibodies that contained but the tumor antigen binding domain and aside to toxic T cell been to meet specifically a cdthree binding to me.
E T cell Engagers, which girls call Cdthree bi specifics activate T cell side of the tumor in order to Potently kill malignant cells.
Before we review these programs. Please note that our first three cdthree by specific programs as targeting see 123, CD 20, it's messed up and receptor to have recently received their nonproprietary names by Dakota, Mad promote them up and take due to bad respectively, and we'll be referring to deal with their new unions. So by Dakota map, it's not one for a four or five well.
Bassil I. Dahiyat: This enables higher selectivity for tumor antigen-expressing cells and greater flexibility in tuning the potency, and hence, efficacy and tolerability of the molecule. We'll be presenting preclinical data from three internally developed XNAB 2 plus 1 bispecific antibodies targeting solid tumors at the second session of the American Association of Cancer Research virtual annual meeting in late June. The next group of bi-specific antibodies are our tumor microenvironment activators.
What about is actually up 1367 checks and Candide imagine X not 180 wait seven.
Now, while we continue to dose patients in our phase one studies or by the code about implement them out and you know it's not a lot of cancers, we'll plan to initiate studies at each additional studies of these programs subject the possible impacts in the company 19 pandemic as I mentioned earlier.
Bassil I. Dahiyat: Rather than directly bridging a cytotoxic T-cell to a tumor cell, our TME activators, as we call them, seek to more effectively reactivate tumor-reactive T-cells than existing therapies. These antibodies simultaneously engage multiple T-cell targets such as checkpoints or agonists. A key feature of our design is to choose individual binding affinities for each T-cell target to give lower binding to T-cells with only one of the two targets on its surface but to have high binding when both targets are present. This zipping up when multiple handholds are present is the same avidity property as in our 2 plus 1 CD3 bispecific.
We also continued to dose patients in the phase one study of pad you'd imagine continue to expected we will present additional data initial data from this ongoing study in your under consumers in gastrointestinal stromal tumors in the second happened this year.
Further we've expanded our cdthree class of bi specifics by developing are actually up two plus one botched <unk> format, usually the same heterogeneity gets not up see demand isn't or other by specific antibodies inside of.
Well, that's two identical tumor targeting command and one cdthree targeting to me the tumor targeting binding domains can vote can find together when there is more target present, a property called indeed.
This enables higher selectively for tumor antigen expressing cells in greater flexibility in tuning the potency and hence efficacy and tolerability of the molecule.
Bassil I. Dahiyat: Now, our approach reduces the need for multiple antibodies, typically using combination therapy, and also allows for more selective targeting of T-cells that have multiple checkpoint expressions, which are typically found more in the tumor microenvironment than in the peripheral. Our three clinical-stage TME activators target different checkpoint or co-STEM combinations and all demonstrate compelling in v-turn and vivo data to support their clinical development. We're conducting phase one studies evaluating these drug candidates and patients with advanced solid tumors. The studies evaluating XNAP22841, which targets CTLA-4 and LAG-3, and XNAP23104, which targets PD-1 and ICOS, are enrolling patients in the dose escalation portion of these studies. And we've recently opened expansion cohorts in the Phase I study of XMAP-201717, which targets PD-1 and C-chelate. These cohorts are enrolling patients with advanced non-small cell lung cancer, renal cell carcinoma, prostate cancer, and other cancers without approved checkpoint therapies. And the study continues to enroll patients in additional dose escalation cohorts. An expansion cohort for patients with melanoma is fully in work.
Well be presenting preclinical data from three internally developed ex not cheapest one by specific antibodies.
Targeting solid tumors at the second session of the American Association of Cancer Research virtual annual meeting in late June.
The next scrutiny by specific antibodies are tumor microenvironment activators, rather than directly bridging aside to toxic T cell tumor cell art.
Yeah me activators, as we call them seek to more effectively reactivate tumor reactive T cells and existing therapies. These antibodies simultaneously engage multiple P.T. cell targets such as checkpoints Dragon.
A key feature of our decided to choose individual binding affinity for each T cell target to get lower buying a T cells. The only one of the tree targets on its surface, but that high buying them a good targets are present.
Stepping up win with multiple hand holder present at the same integrity properties in our two plus one cdthree bi specifics.
Now our approach reduces the need for multiple antibody typically used in combination therapy, an awful lot from more selective targeting T cells that have multiple checkpoint expression. We typically found more in the tumor micro environment than in the periphery.
Preclinical stage Timi activators target took a checkpoint or coast in combinations and all demonstrate compelling and be trying to either data to support their clinical development.
What conducting phase one studies evaluating these drug candidates in patients with advanced solid tumors. The studies evaluating ex NAV to 24, one which targets TTR like foreign lag three and actually have to three went up for which triggered PD one I coast enrolling patients who the dose escalation portion of these studies.
And we've recently opened expansion cohorts in the phase one study that's not to 0717, which targets PD one teacher lift for these cohorts are enrolling patients with advanced non small cell lung cancer renal cell carcinoma, prostate cancer and other cancers got approved checkpoint therapies in the study continues to enroll patients in additional dose escalation cohorts separately.
Bassil I. Dahiyat: The American Society for Clinical Oncology accepted an abstract containing initial data from the Dose Escalation Cohorts for publication in their virtual scientific program, which will appear online next Wednesday, May 13. We plan to update these data through a, Finally, we're developing a series of cytokines, which are immune signaling proteins that are built on the XMAP biospecific FC domain and incorporate our Xtend technology. Using our FC domain and tuning the potencies enables more druggable cytokines. Potentially Superior Tolerability, Slower Receptor-Mediated Clearance, and Longer Half-Life.
And expansion cohort for patients with the melanoma is fully enrolled.
The American society for clinical oncology, except in an abstract containing initial data from the guess escalation cohorts for publication in their virtual side of the program, which will pure online next Wednesday may 13th we plan to update these data to a press release.
Finally, we're developing series a suite of cytokine, which are immune signaling proteins that are built on the ex that bucks or the gifts you mean incorporate or extend technology using our FC domain and tuning dependencies enables more druggable cytokine.
But potentially superior tolerability slower receptor mediated clearance longer huh.
Bassil I. Dahiyat: Our first cytokine program, and the leader in our collaboration with GenTech, is XNAV24306, which they are denoting as RG6323. It's an IL-15, IL-15 receptor alpha complex fused with our bispecific F-seed. It targets the expansion and activation of T-cells in natural killers.
The first thought it can program in a leading our collaboration with Genentech ejection up to four three jurisdiction, which they are denoting as RG sixthree cheap.
You can I'll 15, I'll 15 receptor alpha complex fused, thereby specific FCD.
You target expansion activation of T cells, and natural killer cells in March Dynetek. That's the first patient phase one dose escalation in expansion study backing up 2.306, the single agent in combination with Tesla isn't up.
Bassil I. Dahiyat: In March, Genentech did the first patient in a phase 1 dose escalation and expansion study of ExNAP24306 as a single agent and in combination with tezolizumab, their anti-PD-L1 antibody. The study is enrolling patients with locally advanced or metastatic solid tumors. Now recall that we can perform our own clinical studies with both our own pipeline assets and non-genetic agents within this collaborative, subject to some conditions. We look forward to planning a number of these combination studies pending completion of the initial dose escalation. We look forward to keeping you informed about all of our clinical programs as they progress. Now, I'll switch to reviewing some updates from our partnerships.
They are anti PDL one antibody.
Study is enrolling patients with locally advanced or metastatic solid tumors.
I don't recall that we could performer own clinical studies with both our own pipeline assets in non genetic agents within this collaboration subject to some conditions. We look forward to planning a number these combination studies pending completion of the initial dose escalation.
We look forward to keep you informed about all of our clinical programs as they progress.
They'll switch to reviewing slipped it's more partnerships, while we attended ongoing partnerships for excellent technology, which should result in so far in one market a product one not wanting to review for marketing approval seven clinical candidates and more in earlier she development, we're only going to update on three today before proceeding the financials.
Bassil I. Dahiyat: While we have 10 ongoing partnerships for XMAP technology, which have resulted so far in one marketed product, one now we're under review for marketing approval, seven clinical candidates, and more in earlier stages of development, we're only going to update on three today before proceeding to finance. Morphosis in 2010 was licensed from Tapacitamab, which was previously known as Mor2O8, and before that, Xmab557. It's an anti-CD19 antibody that we designed and initially developed incorporating our cytotoxic FC domain for high ADCC function. In late February, the FDA accepted Morphosis' BLA submission for treating patients with diffuse large B-cell lymphoma, for which he received a $12.5 million milestone. Their submission was granted priority review and received a to-do for goal date of August 30, 2021. They were eligible for additional milestones and royalties on sales in the high single to low double-digit rate percentage.
Morphosis in 2010 license from a tap to sit a map, which was previously known as more chew away and before that X now 557 for.
Anti CD 19 antibody, we designed and initially developed incorporating our cytotoxic FC domain for highest <unk> right ADCC function.
Late February the FDA acceptable to us it should be at least admission for treating patients with the piece part B cell lymphoma Hoochie received a 12.5 million dollar milestone payment. There submission was granted priority review and received to date. The goal date of August 30, 2020 were eligible for additional milestones royalties on sales and on sale in the high single to low double digit percentage.
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We've also entered into research collaborations include the creation of novel ex now, but specific antibody. We advanced by partners. For example, AG 509 engine steep one bikes cdthree two plus one bystolic antibody developed under our collaboration with them engine is developing empty fivenine for patients with prostate cancer in humans.
Bassil I. Dahiyat: We've also entered into research collaborations that include the creation of novel XMAP bispecific antibodies to be advanced by partners. For example, AMG509 is Amgen's STEEP1 by CD3 2 plus 1 bispecific antibody developed under our collaboration. Amgen is developing AMG 509 for patients with prostate cancer and Ewing sarcoma. Preclinical data were presented during Session 1 of the AACR Virtual Annual Meeting in April. Amgen is now recruiting patients in a Phase I study of AMG509 in patients with metastatic castration-resistant prostate cancer. Now, last program is in January, we entered into a technology license agreement with Gilead.
Circle preclinical data were presented their excess Wanna be HCR virtual annual meeting in April.
Amgen is not recruiting patients in phase one study names you five and nine patients with metastatic castration resistant prostate cancer.
Cost of cancer.
No.
Last program in January we entered into a technology license game Gilliat without accessing our extend extended half life inside of talk Skupski technologies for developing and commercializing.
Bassil I. Dahiyat: with X.
Bassil I. Dahiyat: Accessing our extended half-life in cytotoxic FC technologies, we're developing and commercializing Elipavimab, their first-in-class, broadly neutralizing anti-HIV antibody in phase one clinical development, as well as up to three additional anti-HIV antibodies. At this time, Gilead has exercised all three options for the additional antibodies, and in total, we've received $13.5 million under the agreement. Now our partnership with Gilead and the expansion of our partnership with VeeR and COVID-19 both highlight our strategy to selectively license access to our XMED technologies for use in developing antibodies with improved properties that show broad applicability in areas such as viral infections. And the plug-and-play nature of our XMAP technologies enables our partners to advance their programs, gaining very little resources or effort from us. Now, with that, I'm going to turn the call over to John Kuch to review our first quarter 2020 financials.
Oh popping up their first in class broadly neutralizing anti HIV antibody in phase one clinical development as well as up to three additional into each of the antibody at this time Gilly Atas exercised all three options be additional antibody in total we received 13.5 million under the agreement or.
Now our partnership with Gilead any expansion of our partnership with gearing Cobot 19, both highlight our strategy to selectively license access correction that technology for use in developing antibodies with improved properties, which has brought a predictability in areas such as borrow infectious disease.
The plug and play nature of our accident technologies enable us enables our partners to advance the program seating very little resources referred from us.
Well that I'm, a turn call over to John Kids to review, our first quarter 2020 financial.
Thank you Beth.
John J. Kuch: Thank you, Basil. Xencor continues to operate from a strong financial position, which enables us to support our portfolio of clinical stage and research stage antibody and cytokine drug programs. Cash, Cash Equivalents, and Markwell Securities totaled $609.9 million as of March 31, 2020, compared to $601.3 million on December 31, 2019. The increase reflects up-front and milestone payments and royalties related to licensing agreements, net of spending, and operations for the first quarter. For the first quarter and for March 31, 2020, revenues were $32.4 million, compared to $111.9 million for the same period in 2019. These revenues include milestone revenue recognized from Morphosis, royalty revenue recognized from Alexion, and licensing revenue recognized from our Immune and Gilead collaborations, compared to revenues from the same period in 2019, which were primarily revenue from our Genentech collaboration.
Glencore continues operate from strong financial position, which enables us to support a portfolio clinical stage research stage by specific antibody.
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Cash cash equivalents in marketable securities totaled 609.9 billion as of March 31st 2020, compared to 601.3 million on December 31st 29 <unk>.
The increase reflects upfront and milestone payments in royalties for me to licensing agreements that have spending on operations for the first quarter.
The first quarter end mercenary first 2020 revenues were 32.4 million compared to 111.99 for the same period he.
These revenues include milestone revenue recognized morphosis royalty revenue recognized Lux, yeah, and licensing revenue recognized from our immune ambulatory operations compared to revenue from the same periods, where 90, what's your primary revenue from Archie Medtech collaboration.
Research and development expenditures in first quarter in 2020, or 33.9 billion compared to 20.29 from same period between 90.
John J. Kuch: Research and development expenditures for the first quarter of 2020 were $33.9 million, compared to $28.2 million for the same period in 2019. The increase is primarily due to increased spending on our Plymouth Tumamab and XNAB 27.1.7 programs, partially offset by reduced spending on our Obexilumab programs. General Administrative Expenses for the First Quarantine in 2020 were $7.2 million, compared to $5.5 million in the same period of 2019. The increase primarily being related to greater spending on personal costs and professional services. The net loss for the period ended March 31, 2020 was $8.1 million, or $0.14 on a fully delivered per share basis for the first quarter, compared to the net income of $80 million, or $1.38 on a fully delivered per share basis for the same period in 2019.
The increase being primarily to to increase spending in our flamel too, Matt and X map 20 someone seven programs, partially offset by reduced spending on our opex on that program.
General administrative expenses for the first quarter 2020 were 7.2 million compared to 5.5, the same periods where Nike.
The increase primarily being related to greater spending on personal cost and professional fees.
Net loss for the period ended March 31st 2020 was 8.1 billion or 14 cents, an upward <unk> per share basis for the first quarter compared to net income of 80 million or dollarsthirty.
<unk> per share basis for centered 29.
Net loss in first quarter 2020, compared net income reported same period. He was primarily due to revenue recognized genetically every should point Nike.
John J. Kuch: The net loss for the First Quarter 2020 compared to Net Income reported for the same period 2019 is primarily due to revenue recognized from the Genentech collaboration in 2019. Non-cash share-based compensation expense for the first quarter 2020 was $6.5 million, compared to 5.9 million for the same period in 2019. Total shares outstanding were $57 million as of March 31, 2020, compared to $56.3 million as of March 31, 2020.
Noncash share based compensation expense for the first quarter 2020 was 6.5 billion.
5.99 for the same peered 29.
Total shares outstanding were 57 million as of March 1st 2020, compared to 56.3 million as Mark said first.
Based on current operating plants, we expect to have cash to fund research and development programs in operations and the 2024 at the end 2020 would between 500 million in 550 million a cash cash equivalents in marketing securities.
Operator: Based on current operating plans, we expect to have cash to fund research and development programs and operations into 2024 and to end 2020 with between $500 million and $550 million in cash, cash equivalents, and marketable securities. With that, we'd now like to open up the call to your questions. Operator. Thank you. Ladies and gentlemen, if you have a question at this time, please press the star and the one key on your touchtone telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. And our first question comes from... Hi, we might be... Sorry, continue. And our first question comes from the line of Jonathan Chang with SVB Larynx. Your line is now open. Hi guys, thanks for taking my questions. First question: can you help set expectations for the EXPAT-2017-1-7 ASCO publication?
That would now like to open up the call for your questions operator.
Thank you.
Ladies and gentlemen, if you have a question at this time. Please press the Star then one key on your Touchtone telephone.
To withdraw your question. Please press the pound key.
Then Bali compiled the kuni roster.
In our first question comes high we might be on Oh.
Sorry continue.
And our first question comes from a lot of Jonathan Chang with SVB, Larry Your line is now open.
Hi, guys. Thanks for taking my questions. My first question can you help set expectations for the ex that she was your 717 Atco publication.
Sure.
Jonathan Chang: Sure. We expect to be able to report the escalation that has already been completed in the dose escalation cohorts, and we're really hoping to see the safety and tolerability of the molecule, which is obviously very important for our product profile to differentiate from the rather toxic regimens that you get with PD-164 blockade, for example, with the bulimia-mab and the volume-mab combination. We're going to look for biomarkers to make sure they're moving in the right direction, and we're going to look to see what efficacy we have from those cohorts. Of course, it's a very heterogeneous patient population, many different tumor types, some with approved checkpoint inhibitors that would make you expect many of the patients would be post PD-1 therapy, some with different kinds of tumors. So, that's the kind of data we'll present, and we've really always thought that the way to get at efficacy is by doing expansion cohorts, and that's something we've just gotten going very recently, because you can do larger numbers of patients with individual tumor types and really have a better shot at studying them.
We expect to be able to report the escalation.
The already completed does escalation cohorts and we're really hoping to see the safety and tolerability. The a molecule, which is obviously very important for our product profile to differentiate from the rather toxic regimens that you get with PD went utility for blockade for example, with on the blending happened to volume out combinations.
For Biomarkers to make sure that moving in the right direction and we're going to look to see what efficacy. We have from from those cohorts of course, it's a very heterogeneous patient population many different tumor types. Some would approve checkpoint inhibitors that would make you expect many of the patients would be post PD, one therapy, some with different kinds of tumors.
So that's that's kind of data will present, and we've really always thought that the way to get at efficacy is by doing expansion cohorts and and that's something we've just gotten going very recently.
Could you can do larger numbers of patients with individual tumor types and really had a better shot at study.
Got it thanks for that color and just to follow up on that or you are you. Since you mentioned recently opened expansion cohorts in this study.
Given the heterogeneous nature of the phase one dose escalation study can you talk about how you're keeping out signals of activity in the data, you're generating and how you're thinking about which indications and settings to pursue further.
Bassil I. Dahiyat: Got it. Thanks for the color. And just to follow up on that, since you mentioned recently opening expansion cohorts in this study, given the heterogeneous nature of a phase one dose escalation study, can you talk about how you're teasing out signals of activity from the data you're generating and how you're thinking about which indications and settings to pursue further?
Yeah, we're thinking about it based on what are the.
What are the places that checkpoint inhibition can move the needle right. So the dose expansion cohorts. We have set up give you an indication there there mixture of indications where there is known checkpoint therapy activity, where there is approved checkpoint inhibitors in were likely everybody's going to be receiving at least PD one loan therapy.
Bassil I. Dahiyat: Yeah, we're thinking about it based on what are the... Where are the places that checkpoint inhibition can move the needle, right? So the expansion cohorts we have set up give you an indication there.
Prior to advancing to a clinical trial those would be our non small cell lung or melanoma in our renal cell carcinoma expansion cohorts those are cohorts, where we hope.
Bassil I. Dahiyat: They're a mixture of indications where there's known checkpoint therapy activity, where there are approved checkpoint inhibitors, and where likely everybody's going to be receiving at least PD-1 alone therapy prior to advancing to a clinical trial. Those would be our non-small cell lung, our melanoma, and our renal cell carcinoma expansion cohorts. Those are cohorts where we hope, you know, we can study enough patients in each of those indications to establish whether we have meaningful activity in each of those indications post-PD-1 therapy. So, looking at the PD-1 relapse and refractive population. Tremendous opportunity, obviously, very high bar. On the other couple of cohorts to give you an indication of the other area we're looking at is prostate cancer, where there's only recently been significant and meaningful clinical activity from checkpoint inhibitors, but still a pretty heterogeneous multi-line cancer that I think has a lot of opportunity that's, relatively speaking compared to other areas in oncology, more open, as well as So with the basic science sort of, if we can establish the basic science around our compound, we can study what's really going on in expansion cohorts.
We can study enough patients in each of those indications to establish what do we have meaningful activity in in Ah Ah Ah each of those indications post PD one therapy. So looking at the PD, one relapse and refractory population tremendous opportunity, obviously very high bar.
On the other couple of cohorts to give an indication of the other area, we're looking where.
Prostate cancer, where there's only recently been significant a meaningful clinical activity from checkpoint inhibitors.
But still pretty heterogeneous multiline, Oh cancer that that I think has a lot of opportunity that's relatively speaking compared to other areas in oncology more open as well as a basket of were unusual rare tumors that have just all sorts of different values that we want to explore so would the basics.
Science sort of.
We can establish the basic science around our compound we can study, what's really going on an expansion cohort.
Got it. Thank you and just one last question it sounds like the code at 19 impact on your ongoing clinical studies is minimal so far I can you expand on this I'm curious because we're hearing varied responses model, even our oncology companies.
Oh, Yeah, I'll, let Alan Yang our Chief Medical Officer.
Bassil I. Dahiyat: Got it, thank you. And just one last question. It sounds like the COVID-19 impact on your ongoing clinical studies is minimal so far. Can you expand on this? I'm curious because we're hearing varied responses among even our oncology patients.
Address that.
Yeah. Thanks Pavel Good question. So you know I can't comment on other companies, but Xencor you know what we've been hearing anecdotally is that a lot of sites are closing two new patient enrollment not because they're being overwhelmed but because they are preparing for potential surge of covert 19 patients.
Bassil I. Dahiyat: I'll let Allen Yang, our Chief Medical Officer, address that.
With that said oncology is a large unmet need and so these would probably be the patients that be therapy. The most.
Allen S. Yang: Thanks, Basil. A good question. I can't comment on other companies, but at Xencor, what we've been hearing anecdotally is that a lot of sites are closing to new patient enrollment, not because they're being overwhelmed, but because they're preparing for a potential surge of COVID-19 patients. With that said, oncology is a large unmet need, and so these would probably be the patients that need therapy the most. And so, you know, these would be the last patients that would be sort of denied access to care because of preparations for COVID. In addition, most of our studies, since they're Phase I, are in dose escalation, so you need very few patients for dose escalation, and so those slots, when they become available to patients, they get filled very quickly by our investigators.
And so you know these would be the last patients that would be sort of denied access to care because of preparations for cold it.
In addition, most of our studies since their phase one aren't dose escalation. So you need very few patients for dose escalation and so those slots when they become available to patients they get filled very quickly by our investigators.
And you know overall be impacted thousand alluded to was on new patient studies and so one can imagine instead of an oncology patients who need to therapy.
When you have a study and you're setting up that studies about contracting sort of getting to sign up to speed, having them learn about the protocols and this is mainly administrative.
Let's see [laughter] excuse me and this can be de prioritize so that's why we haven't seen much disruption.
Allen S. Yang: And, you know, overall, the impact that BASIL alluded to was on new patient studies. And so one can imagine, instead of an oncology patient who needs therapy, when you have a study and you're setting up that study, it's about contracting, sort of getting the site up to speed, having them learn about the protocols, and this is mainly administrative. And this can be de-prioritized.
Yes, I think it really comes down to the lack of the drugs different sites have different.
You know what they've done.
Allen S. Yang: Yeah, I think it really comes down to the luck of the draw.
Bassil I. Dahiyat: I think it really comes down to the luck of the draw.
Bassil I. Dahiyat: You know, what they've done. Before we go to the next question, I just wanted to comment that there have been on and off problems with the Q&A queuing system that we're going to continue through, but just bear with us if anything does pop up. I'm ready for the next question.
Operator: Thank you. And our next question comes from the line of Arlinda Lee with Kennecore. Your line is now open.
Arlinda Lee: Hi guys, thanks for taking my questions. I was curious about the, I guess, milestone flow on Morphosis 208. The 12.5 million milestone, can you talk about what that's for and what the 25 million upcoming might be? And then, also, I was kind of curious, you know, we've been talking a lot about your IO-IO bi-specifics for a while and how that was, a focus, and now that you have this, your next wave seems to be the two to ones, and can you kind of talk about the shift? in interest in focusing from the IO-IO to the two-to-one.
John J. Kuch: John, do you want to take the milestone question?
John J. Kuch: Sure, sure. Thanks, Arlinda.
Bassil I. Dahiyat: Yes, we had reported in our 10-K that there were 37.5 million in regulatory milestones related to the compound. We received 12.5 million upon acceptance of the BLA by the FDA, which I guess occurred, I think, in January or February. So that's 12.5 million. The other 25 million relates to additional regulatory approvals related to the compound. Thank you.
Bassil I. Dahiyat: Thank you. And I'll take the IO-IO bi-specific antibody and 2 plus 1 CD3s. We go where the scientific hypotheses that we think are going to drive the best chance at having a differentiated drug that can help patients are. And with three IO-IO bi-specifics in the clinic, that's testing three distinct hypotheses that we're excited about. https://www.youtube.com.uk But it's all going into expanding what we're doing into being more opportunities within solid teamers, as opposed to in our earlier work, where the first two programs were heme.
Bassil I. Dahiyat: Got it. Thanks. Could I also ask a question on the 24306 IL-15 compound in collaboration with Genentech? Um, you guys have talked about having a fairly aggressive program. I'm curious, um, since the trials have already started. Thank you all for joining us today.
Bassil I. Dahiyat: We've been guiding that there's unlikely to be data from that program this year. That's in the hands of Genentech. They're executing on the trial, and we have to reach agreement with them on when we do data releases. But I would not expect it this year, given that this is the first patient in March. As for COVID-19 impacts, I know they're very committed to the trial. They got a patient going right when COVID-19 was starting to ramp up, and that's what we know, that they're still very committed, and there's a lot of activity going on. If and when we learn something meaningful about COVID's impact, we'll absolutely report that in our next update.
Operator: Thank you. And our next question comes from the line of Peter Lawson with Barclays. Your line is now open. Hi guys, this is Waleed Anpur.
Peter Richard Lawson: Peter, thanks for taking our questions. I apologize if I missed anything earlier. I had a bit of difficulty with the conference line, but I just wanted to ask a question on XMAB 18087. I'm wondering if you can, you know, give us clarity on whether or not that data is still on track for the second half and, you know, maybe tell us how enrollment is going for the study and whether you're seeing any challenges for patients being able to get follow-up and, you know, just an update on that study.
Bassil I. Dahiyat: So yes, we reaffirmed earlier on the call that XMAB-18087, now called Pidutumab, we expect to give a data update on the phase one study second half of this year. We do continue to enroll patients. Allen, do you wanna touch on the question regarding follow-up visits and whatnot?
We do continue to enroll and Alan do you want to touch on the question regarding follow up visits and whatnot.
Allen S. Yang: Yeah, I just want to remind you that neuroendocrine tumors and gastrointestinal tumors are rare tumors, but despite that, we still are enrolling well, and in the patients that are on study, we haven't seen anybody miss key visits, and that goes across our studies, and key visits would be dosing visits or tumor assessment visits, so I think we're doing pretty well. Great, great. Thank you. That's very helpful. And what can we expect to see in that data update? Number of patients and type of data, and then maybe you can help, you know, sort of set a bar for certain efficacy and safety benchmarks that you may want to meet to help consider your results positive.
Yeah, just want to remind that neuroendocrine tumor and gestural tumors are are rare tumors ah, but despite that we've still or enrolling well and in this patients that are on study we haven't seen any buddy Miss key visits and that goes across our studies in key visits would be go seem visits or tumor assessment says it. So I think we're doing.
Pretty well.
Great Great. Thank you that's helpful and what can we expect cosine that deal they number of patients and.
Type of data and then maybe you can help you know sort of set a bar for certain 60 and safety benchmarks that you may want to meet Oh consider your results positive.
So we're not guiding on the number of patients. It's you know we've been we've been death is going into a number of cohorts <unk>. So it is going to be in that in that range. When you consider typically have three six patients per cohort.
Allen S. Yang: So we're not guiding on the number of patients. You know, we've been dose escalating to a number of cohorts, but it, so it is going to be in that, in that range when you consider that typically you have three to six patients per cohort. Without getting into any specifics about the upcoming data, in general, these neuroendocrine tumors are not, they don't typically respond with a resistant sort of response. I think you, from the approved agents, they typically have around a 10 or 5 or 10% response rate, but what happens is you get a duration of the patient continuing on and being, you know, being tolerant to the therapy, of course, and not getting worse, right?
Without getting into any specifics about the upcoming gate at in general These nuranda can chambers and are.
Not.
They don't typically respond with a resist sort of response I think you from the approved agents. They typically have around a 10 or five or 10% response rate, but what happens you you get a duration.
The patient continuing on and and being you know being tower to the therapy of course, and and and not getting worse right. So the the proved gauge in recent approved agent for example.
Allen S. Yang: So the approved agent, the recent approved agent, for example, which is a radionuclide peptide conjugate, was approved on PFS and OS. So that might maybe set your expectation for what you would hope to see. On the safety front, you know, it's a CD3 biospecific against a solid tumor where the antigen is expressed in various neuroendocrine tissues. So I think it's gonna come tissue by tissue where those neuroendocrine cells are making sure that a patient can tolerate it. But these are advanced net patients with very few options. There's some latitude there, yeah, if it's showing activity.
Which is a radio new Clyde peptide conjugate was approved on P.F.S. and L.S.
So.
That might maybe set your expectation for what you would hope to see on the safety front you know, it's a C.D. three by specific against the solid chamber, where the engine is expressed interest or under can tissues. So I think it's going to come tissue by tissue, where there's no under consoles are making sure that a patient can tolerate it but these are advanced net patients.
With with very few options so.
There's a there's there's some latitude there yeah, if the show if it's showing activity.
Allen S. Yang: Got it. Thank you. Thanks for taking the questions. Thank you. And our next question comes from the line of Gabriel Fung with Mizzou Health Securities. Your line is now open. Hey Basil, thanks for taking the question. This is on behalf of Gabriel Fung for Mara.
Started thank you thanks for taking the questions.
Thank you.
And the next question comes from the line of Gabriel phone.
<unk> Your line is now open.
<unk> I think particular question that is on Gabriel for Mira.
Gabriel Fung: And just the first question here, this is regarding the COVID-19 impact. It's understandable that delays may be felt, but I'm just wondering if you can quantify the magnitude of the delay. Is it within like a quarter or maybe two? And in the trials that you're expecting to start as of last quarter, have you already enrolled any patients? And I have a few more follow-ups after that.
And just the first question here regarding the code that 19 impacts it's understandable that delays, maybe so but I'm. Just wondering if you can no quantify the magnitude of the delays it within like a quarter or maybe two.
And in the patient.
Files that are ready going I mean, starting to trials that address expecting to start as of last quarter have you already enrolled any patients.
And how people were pop up after that.
So we're going to average about five questions per enlist I'm guessing so to get T. Your first question. This study's we had guided that we were going to initiate this year where.
Bassil I. Dahiyat: So, we're going to average about five questions per analyst, I'm guessing. So, to get to your first question, the studies that we had planned that we were going to initiate this year were, in the second half, we would announce our plans for our Palomodumab, our CD20, CD3, vice-specific, for the next set of trials. For that reason, we have no guidance we can offer on what kind of delays might emerge from COVID-19. It seems reasonable to assume there will be, but it's far enough off, and the COVID situation. We had planned by mid-year to open the study for Vibacodumab, our CD123-CD3, a new study, where we would give details at the time when it opens. That's how our agreement with Novartis works.
The second half, we would announce our plans for our <unk>, our C.D. 20, C.D. three by specific for for the next set of trials for that we we have no guidance. We can offer on what if what kind of delays might emerge from covered 19, it seems reasonable to assume there will be but it's far enough often the kobe situation is so fluid we don't know.
We had planned by mid year to open the study for by the <unk>.
R.C.D. 123, C.D. three an a new new study, where we would give details at the time when it opens that's how our remote artists works.
Bassil I. Dahiyat: That has, I think, had some impacts because of the administrative points and some study sites just not wanting to take on new studies while COVID was feared, and it still is feared, of course. I don't know if we can give a specific amount of time. We're hoping to be able to initiate that study later in the part of mid-year, certainly in the second half, we hope, but we don't have anything more specific than that.
That is is has I think felt some impacts because of the administrative.
Points and some study sites just not wanting to take on new studies. While coded was was was feared and it still is period of course I don't know if we can give a specific amount of time, we're <unk>, we're hoping to be able to initiate that study sort of later in the part of mid year certainly in the second half we hope that we we.
We don't have anything more specific than that now you had some other aspects to your question.
Bassil I. Dahiyat: That's good. I'll jump to the next question. It's pretty quick. It's just really a bunch of cash. I'm giving you a cash position right now. I'm just wondering if it makes sense to even look externally for additional assets or technologies. And that's it. Thank you.
Oh, that's good Oh come to the next question, it's a pretty quick it's just reading bunch on cash well given no task position right now I'm just wondering if it makes sense to even look externally for additional assets are technologies.
And that's it thank you.
We we always are looking you know and it's it's as a small company or a bit disadvantaged and I think we're always looking for great new technology or or molecules that can fit.
Bassil I. Dahiyat: We always are looking, you know, and it's, as a small company, you're a bit disadvantaged, and I think we're always looking for great new technology or molecules that can fit. I don't think we make it a primary corporate goal, but it's always a good idea. You should never feel like what you've got in your own shop is the end of the world. That said, we do have a very rich and very busy, busy development team and a lot of research ongoing, but it's something we have in mind for sure.
I don't think we make it a primary corporate goal, but it's always a good I do you should never feel like what you've got in your own.
Shop is the end of the World that said, we do have a very rich you know very busy busy development team and a lot of research on going.
But it's something we have in mind for sure.
Okay.
Edward Andrew Tenthoff: Thanks, guys. Thank you. And our next question comes from the line of Ed Tenthoff with Piper Jaffray. Your line is now open. Great. Thanks so much. It's good to hear your voices.
<unk>.
And our next question comes from the <unk> turned off with Piper Jaffray. No. One is now.
Right.
<unk> versus I'm Gonna criminal Oh, well from an earlier question or oil for food.
Edward Andrew Tenthoff: I want to kind of follow up on an earlier question on IL-15. And I'm really trying to understand what are the optimal potential combinations here. So really, how does that mechanism play best either with checkpoints or other targeted agents? So how are you guys at a very high level thinking about developing that candidate with Genentech? Thanks so much.
I'm really trying to understand.
What are the optimal potential companies, who cares really how does that mechanism plenty best if it would check points or other targeted it too. So how are you know sort of very high level thinking about developing that <unk>, where thoughts about <unk>.
Hey, Thanks, Tad, it's great to hear a great to her all you guys minutes being safe and sound.
Bassil I. Dahiyat: Hey, thanks, Ted. It's great to hear all you guys are safe and sound. So, the initial work is with the checkpoint inhibitor. It's the atezolizumab PD-L1 molecule from Genentech. It's an approved agent. It's doing pretty well, even though it's, I think, third in the PD-1L1 space. It's doing pretty well when it's expanded.
<unk>.
So the initial work is with the checkpoint inhibitor, it's would be a pencil isn't that P.D. at one molecule from Jan tickets and approved agent. It's it's it's doing pretty well, even though it's I think third and the P.D. one o. one space, it's doing pretty well when expanding we are oh pulled it back can lead to a number of different exciting Clint.
Bassil I. Dahiyat: We are hopeful that that can lead to a number of different exciting clinical trials that they can initiate once we're out of initial dose escalation. I think that there are certainly other checkpoint inhibitors, and we have eyes for our own pipeline. If the molecule gets through this first trial nicely, then we would certainly imagine looking for ways to synergize with those checkpoint inhibitors. I do think that the natural killer cell opportunities are there. There's nothing we have specifically that we can guide to right now, though we in Genentech are talking avidly about them because it's both the T cells and the NK cells that IL-15 really drives. I think that we're gonna, as we get through this phase one and get tolerability data and understand our dose and hopefully see something exciting, we'll be able to pin that down more. But there are a lot of different opportunities, and so for starters, let's make sure we check the box on a checkpoint inhibitor. For tezo, Genentech is very, very motivated to advance. Yep, makes sense, great, and the whole NKTown5 makes a lot of sense. Thanks so much for watching.
Trials that they can initiate once we're out of initial tests escalation I think that there's certainly other checkpoint inhibitors and we have eyes for our own pipeline. If if the molecule get sued his first a trial nicely then we would certainly imagining looking for how we can synergize, but those check when inhibitors I do think that the <unk> natural killer cell.
Opportunities are there there's there's nothing we have specifically that we can guide to right now the we in genetic are talking avidly about them because it's both the t. cells any encased felt that Oh 15 really drives I I think that we're gonna.
As we get through this phase, one and get Tolerability data and understand our dos and and hopefully see something something exciting we'll be able to pin that down more but there's there's a lot of different opportunities and so for for starters, let's make sure we check the box on the checkpoint inhibitor for the test genetic is very very motivated to advance.
Yep <unk> Fuck makes a lot of thanks, so much for the up it's <unk>.
Thanks to thank you. Thank you.
The next question comes from a line of Gregory Windsor with RBC capital market. Your line isn't open.
[noise] right.
Right.
Edward Andrew Tenthoff: Thanks so much for the update. Stay safe, guys. Thanks Ted. Thank you. Thank you. And our next question comes from the line of Gregory Rinza with RBC Capital Markets. Your line is now open. Hi, this is Xinyue Lu from Kirkbride. Thank you for taking my questions and congratulations on the quarter. I have two questions. First, what are your disclosures?
<unk>.
Right.
Yeah.
Yeah.
And then.
Mmm.
Oh.
Minus your priorities them on early.
Hmm.
Mmm.
Super hard to hear there was some definite connection issues. There I believe your first question.
Was about are we guiding on any data <unk> for this year, we have not yet guided on those we we we will we we can give updates on when we might have data from those later in the year, we haven't got it on anything yet so far.
Gregory Rinza: for the ongoing monotherapy trials of Pomodimab and 14-045-035.
Gregory Rinza: And then my second question is, how do you think COVID-19 has shaped your development strategies, and can you remind us of your priorities among the early stage programs? Thank you.
And I think it's prudent for us to make sure we understand the code impacts fully before we do that said I think you know as as Alan has said in a in some of the earlier comments. So far are trials continued to enroll they've done well some of its luckily draw with our sites, but you know, we don't know where the future is going to be so.
Bassil I. Dahiyat: So it was super hard to hear. There were some definite connection issues there. I believe your first question was about whether we are guiding on any data readouts for Plamodimab and Vibocodimab for this year. We have not yet guided on those. We can give updates on when we might have data from those later in the year. We haven't decided on anything yet, and I think it's prudent for us to make sure we understand the COVID impacts fully before we do. That said, as Allen has said in some of the earlier comments, so far, our trials have continued to enroll, and they've done well. Some of it's the luck of the draw with our sites, but we don't know where the future is going to be, so we're just going to stay very vigilant.
We're just going to stay very vigilant, but so far the impacts if it's somewhat relatively limited on our on our enrollment, though our new studies start in particular for five Dakota <unk>. We know that that's impacted because that was something that was getting into the advanced stages of planning and prep.
And and that's instead of you know we were hoping mid year. It it it it's going to slide from there, but we don't know exactly how much.
Bassil I. Dahiyat: But so far, the impacts have been somewhat relatively limited on our enrollment, though our new study start, in particular for Vibocodimab, we know that that's impacted because that was something that was getting into the advanced stages of planning and preparation. We were hoping mid-year it would slide from there, but we don't know exactly, and I couldn't hear anything beyond that.
And I couldn't hear anything beyond that.
A little better.
Okay. My second question was how do you think we'll be 19 have shaped your development strategies in your mind as your priorities them on the early space program.
Oh right. So our priority is always to take all of our little shade programs. We can get some element of concept data or not from them in a meaningful trial.
Xinyue Lu: A little better
Xinyue Lu: My second question was, how do you think COVID-19 has shaped your development strategies, and can you remind us of your priorities among the early stage programs?
And then from that point decide the strategy. So we've got to the point, where we have acted doses for five covered by the could amount of implemented on it. So we're initiating new studies with those would be earlier ones were still in that initial data gathering space. So the priority is to manage the portfolio in a way that as we gather more data across.
Bassil I. Dahiyat: Oh right, so our priority is always to take all of our real estate programs until we can get some element of proof of concept data or not from them in a meaningful trial.
Fully we pick the winters in advance those so that's that's how that is I don't think covert 19 has changed our priorities.
Bassil I. Dahiyat: And then from that point, decide the strategy. So we've got to the point where we have active doses for vivacodumab and pomodumab, and so we're initiating new studies. With those, with the earlier ones, we're still in that initial data gathering phase. So the priority is to manage the portfolio in such a way that as we gather more data across that portfolio, we pick the winners in advance. So that's, that's how that is. I don't think COVID-19 has changed our priorities in any way regarding that. I think part of the reason for that is that it's only been a couple of months.
In any way regarding that I think part of the reason for that is you know it's only been a couple of months, we don't know exactly where coping 19 is going to impact our ability to your clinical trials at the industry or anything over over the next few.
Even years I will say the restaurant cash position allows us to continue on and a fairly you know aggressive stance like we can try to all of our clinical development.
For the time being and still play this strategy forward.
Mmm, great. Thank you very much.
Thank you.
Huh.
Thank you and our last question comes from the line of <unk> with Guggenheim Security is your line is no open.
Bassil I. Dahiyat: We don't know exactly where COVID-19 is going to impact our ability to do clinical trials in the industry or anything over the next few years. I will say that our strong cash position allows us to continue on in a fairly, you know, aggressive stance like we've been trying to do all of our clinical development for the time being and still play this strategy forward.
[noise] great well thanks for taking the question here just one really for me you know obviously, we've gotten some activity data for for pretty wants to T.L.A. four by specific some a couple of different companies, including one that'll come and ask when I guess for me. Your question is is is sort of you know it's early data says, but I mean.
What what do you use what are you going to what do we expect in terms of you know ultimate differentiation I mean, what are the.
Bassil I. Dahiyat: Great, thank you very much. Thank you. Thank you. And our last question comes from the line of Etzer Darout with Guggenheim Securities. Your line is now open.
I think the drinks were and your those expensive studies is you know close P.D. one patients. So I mean, it just is that one area, where you kind of see.
Etzer Darout: Great, thanks for taking the question here. Just one really for me, you know, obviously we've gotten some activity data for PD-1 CTLA-4 biospecifics from a couple of different, and I guess for me the question is, it's sort of, you know, it's early data sets, but what do you expect in terms of, you know, ultimate differentiation? One of the things that you're explaining in your dose expansion studies is for post PD-1 patients, so I mean, it just is that one area where you kind of see your assets sort of being able to differentiate over some of these others that are sort of progressing through the clinic. Thanks.
Your assets sort of being able to differentiate over some of these others that are sort of progressing through the the clinic. Thanks.
Yeah, I think our strategy is to look at both post P.D. when patients in in in indications repeated ones are established.
And look at other indications, where there's a good biological hypothesis in particular procedurally for we do hope that our design makes her molecule tolerable and easily combinable because of course, there's always a desire to combine with whether it's chemo were targeted agents or what have you would these molecules and cancer combination therapy always ends up being something.
Bassil I. Dahiyat: Yeah, I think our strategy is to look at both post PD-1 patients in indications where PD-1s are established and look at other indications where there's a good biological hypothesis, in particular for CTLA-4. We do hope that our design makes our molecule tolerable and easily combinable because, of course, there's always a desire to combine it with other agents or what have you with these molecules, and cancer combination therapy always ends up being something you look at. You know, the differentiation, I think our molecule is designed to be truly selective in terms of targeting and to get access to the tumor as well as on the side of safety. But I think the data is far too early. That's how we've designed it to differentiate itself, and we'll see how it all plays out over the next few quarters.
You look at you know the differentiation I think our molecule was designed to to be truly a selected as possible for the double positive cells and we'll we'll see how that plays out as though.
In terms of targeting and to get access to the tumor as well as in the.
Side of safety, but I think at the data is far too early that's our that's how we designed it to differentiate itself and we'll see how it all I would know plays out over the next the next few quarters.
Right. Thank you.
Thank you.
And this doesn't food today's question and answer session.
I would not like to turn the conference call back to Basil value.
<unk> well I <unk>.
I'd like to think think everybody very much for joining us today and also bearing through the multiple technical difficulties, including the my being on mute for the first two minutes always more challenging when we are all remotely located like we are these days and hope it 19.
Bassil I. Dahiyat: Thank you. And this does conclude today's question and answer session. I would now like to turn the conference call back to Basil Dahiyat for any closing remarks.
Bassil I. Dahiyat: I'd like to thank everybody very much for joining us today and also bearing with the multiple technical difficulties, including my being on mute for the first two minutes. Always more challenging when we are all remotely located like we are these days in COVID-19. I look forward to catching up again and giving further updates on our progress throughout the year. And in the meantime, I hope everybody stays safe. Thank you.
I look forward to catching up again getting further updates on our progress that year and in the meantime, I hope everybody Stacey.
<unk>.
[noise], ladies and gentleman, who stays conference call. Thank you for participating you may know disconnect.
[music].
Yeah.
Yeah.
[music].
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
Yeah.
[music].
BF-WATCH TV: BF-WATCH TV 2021