Q1 2020 Earnings Call

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Operator: Good morning, ladies and gentlemen, and welcome to the CytomX Therapeutics First Quarter 2020 Financial Conference Call. At this time, all participants are in a listen-only mode.

Operator: As a reminder, this call may be recorded. I would now like to introduce your host for today's conference, Christopher Keenan, Vice President of Investor Relations. Chris, you may begin.

Christopher Keenan: Good afternoon, and thank you for joining us. Earlier today, we issued a press release that included a summary of our recent progress and our first quarter 2020 financial results. This press release and a recording of this call can be found under the Investors & News section of our website at CytomX.com. With me today are CytomX President, Chief Executive Officer, and Chairman, Dr. Sean McCarthy, and CytomX's newly appointed Chief Financial Officer, Carlos Campos. During today's call, we will be making forward-looking statements because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict, and many of which are outside of our control. Important risks and uncertainties are set forth in our most recent public filings with the SEC at SEC.gov, including our Form 10-Q filed today. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments, or otherwise. I will now turn the call over to Sean.

Sean A. McCarthy: Great. Thanks, Chris.

Sean A. McCarthy: And good afternoon, everybody. Thanks for your patience as we got the call up and running. I gather there's quite a lot of call volume at the moment.

Sean A. McCarthy: [inaudible] Anyway, once again, good afternoon, and thanks for joining us. It's a pleasure to be here to provide an update on our progress during the first quarter of 2020. I'll begin today's call with a brief overview of our business operations against the backdrop of COVID-19, and then we'll review first quarter highlights across the pipeline. I'll then turn the call over to Carlos, our new CFO, who you just heard about from Chris, and Carlos will review our first quarter financial results, and I'll wrap up and then open the call to questions.

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Sean A. McCarthy: Let me start by saying that all of us at CytomX hope that you and your families are well and keeping safe during the ongoing pandemic. The situation is impacting all of us in different ways, and it looks like it will continue to do so for some time. We are committed to ensuring the continued well-being of those involved in the conduct of our business. This includes the patients, the staff, physicians engaged in our clinical trials, the vendors and partners who support these trials, and, of course, our dedicated employees who continue to impress with their drive and focus during these challenging times. Despite the operational challenges presented by COVID-19, our team remains highly focused and very mindful that, as the American Cancer Society has recently reminded us all, cancer is not waiting, and so neither are we.

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Sean A. McCarthy: At CytomX, we see a major opportunity to more effectively target therapeutic antibodies into disease tissue, generating new classes of anti-cancer therapies. We believe our unique pro-body therapeutic platform represents a fundamental advance in the field of antibody engineering. And we are highly focused on using our platform to discover and develop a broad clinical pipeline of novel drug candidates to make a meaningful difference in the treatment of cancer. Our unique science offers the potential for new and highly effective anti-cancer therapies, including first-in-class molecules against novel undruggable targets, potentially best-in-class molecules against validated targets, and new combination therapies. ProBodies are fully recombinant antibody prodrugs comprised of a therapeutic antibody and a mask designed to block the binding of the antibody to its target until the mask is removed. Mask removal is achieved specifically and selectively within cancer tissue by certain disease-associated proteins called proteases that we know are present and active in most cancers.

Good thing, ladies and gentlemen, and welcome to the Cytomx Therapeutics first quarter 2020 financial conference call.

Time, all participants are in a listen only not.

As a reminder, this call maybe recorded I wouldn't I like to introduce your host cities Conference Christopher Keenan vice-president, an investor relations Christy meet again.

Good afternoon, and thanks for joining US earlier today, we issued a press release that includes a summary of our recent progress and our first quarter 2020 financial results. It's press release into recording of this call can be found under the investors in news section.

Sean A. McCarthy: Proteases are, in effect, molecular scissors which, in the context of tumor progression, function to cut a path for invading and metastasizing cancer cells. Our ProBody strategy is to leverage tumor proteases to localize antibody activity to cancer tissue, thereby decreasing target engagement in normal tissues and broadening or even creating a therapeutic window. We have pioneered this new approach that we believe has the potential to improve and optimize a range of antibody formats, including cancer immunotherapies, antibody drug conjugates, and T cell engaging bispecific antibodies. Despite the emergence of COVID-19, we had a very productive and important first quarter toward the ongoing advancement of our strategy of developing innovative cancer therapies in areas of significant unmet medical need and with a particular emphasis on undruggable targets.

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With me today are sites, how much President Chief Executive Officer, and Chairman Doctor, Sean Mccarthy inside Tomex is newly appointed Chief Financial Officer, Carlos Can't Boy.

During today's call, we will be making forward looking statements because forward looking statements relate to the future they're subject to inheriting uncertainties and risks that are difficult to predict and many of which are outside of our control.

Important risks and uncertainties are set forth in our most recent public filings with the S.P.C. at S.C.C. Darko, including our foreign 10 Q. file today.

We undertake no obligation to update any forward looking statements, whether as a result of new information future developments or otherwise I will now trying to call over to Sean.

Great. Thanks, Chris then cut off the mean everybody affects your patience as we were getting the coal up and running.

Quite a lot of cool volume at the moment.

[laughter] anyhow I wasn't going good afternoon, and thanks for joining us it's a pleasure to be here to provide an update on our progress during the first quarter of 2020.

Oh Big in today's cold with a brief overview of our business operations against the backdrop with coded 19.

Sean A. McCarthy: I'd like to start today's update with CX2009, our wholly-owned pro-body for a conjugate that targets the previously undruggable target CD166. CD166 is a tumor antigen that's expressed at high levels on most solid tumors, but it's also present in most normal tissues, ruling it out as a target for a conventional antibody drug conjugate. Previous data from phase 1 dose escalation in various solid cancers have shown CX2009 to be well-tolerated and clinically active as monotherapy at doses of 4 mg per kg and above. This dose is the threshold at which drug conjugates comprising the DM4 payload, the warhead on CX2009, have been shown by others to be active in the clinic. Clinical activity was observed in breast, head and neck, and ovarian cancers with CX2009.

Then we'll review first quarter highlights across the pipeline Oh, then turned the cold it was Carlos or new see if I want you to set off from Chris.

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Open the cold at four questions.

Let me start by saying that all of US assignments hope that you and your family is a well in keeping safe during the ongoing pandemic. The situation is impacting all of us in different ways and it looks like it will continue to do so for some time.

We are committed to ensuring that continued well.

Well being of those involved with the compound about business. This includes the patients the stuff positions engaged in our clinical trials the vendors apartments, who support these trials and of course are dedicated employees you continue to impress would that drive and focus during these challenging times.

Despite the operational challenges presented by covered 19, our team remains highly focused and very mindful that as the American cancer Society has recently reminded us all cancer is not waiting and so neither all week.

I think we see a major opportunity to more effectively target therapeutic antibodies into diseased tissue generating new classes. All as he has a therapies. We believe are unique property therapeutic platform represents a fundamental advanced in the field of antibody engineering.

We are highly focused on using our platform to discover and develop a broad clinical pipeline of novel drug candidates to make a meaningful difference in the treatment of cancer.

Are unique size office, the potential for new and highly affected I see cats therapies, including first in cost molecules I guess no undruggable targets.

Sean A. McCarthy: And we will be presenting updated data from Phase 1 dose escalation for this agent at ASCO in a couple of weeks. In the fourth quarter of 2019, we announced the initiation of a Phase II expansion study of CX2009 monotherapy in patients with hormone-receptor positive HER2-negative breast cancer at the dose of 7 mg per kg administered every three weeks, with the objective of enrolling up to 40 patients. Enrollment was initiated, and patients were treated during Q1, but regrettably, the COVID-19 situation led us to temporarily pause new patient enrollment and new site activation in this study. However, our team continues to closely monitor emerging health authority guidance and IRB Ethics Committee recommendations.

The best thing Cos molecules I guess validated targets.

New combination therapies.

Properties are fully recall, but it's I think <unk> drugs comprised that'd be therapy to kind of your body and the mosque designs to block the bindings the antibodies to his target until the mosque is removed.

<unk> chief specifically in selectively within cats are tissue by certain diseases associated protein school proteases that we know our present active in most cancers.

Chances are in effect molecular scissors, which in the context of tumor progression function to cuts upon us for invading and metastasized in cancer cells.

Oh <unk> strategy, a celebrity cheaper protein is just to localize activity activity into the castle tissue that by decreasing target engagement in normal tissues, I'd, broadening or even creating a therapeutic window.

We have pioneered this new approach that we believe has the potential to improve and optimize a range of antibody format.

Looting cats from either puppies.

<unk> at and T.'s that occasion by specific antibodies.

Despite the emergence all coded 90, and we had a very productive and important first quarter towards young going at Boston about strategy developing innovative cancer therapies in areas that significant on medical need and with a particular emphasis on undruggable targets.

Sean A. McCarthy: And our goal is to resume the CX2009 clinical program as soon as possible. Now, staying with the theme of unruggable targets, I'd now like to turn to CX2029, a CD71-targeting pro-body drug conjugate that we're developing in partnership with AbbVie, and for which, in Q1, we announced the achievement of a major collaboration milestone. Long considered a high-potential but undruggable antibody-drug conjugate target, CD71 is known as a professional internalizer, given its role of moving iron from the extracellular space into intracellular compartments. And it does this in all dividing cells. In fact, many consider CD71 to be the gold standard internalizer to assess the in vitro activity of antibody-derived conjugates. However, the presence of CD71 on normal cells has been an impediment to its use as a drug target.

I'd like to start today that they would see x., two 009 or <unk>.

[laughter] calms you get the targets that previously Undruggable target C.D. 166.

C.D. 166, because h. you might imagine this expressed the high levels all most knowledge humorous, but it's also present almost normal tissues ruling it as a target for a conventional <unk>.

Our previous he presented days isn't phase one does escalation in various solid cancers has shown C.S. 2000 lives to be well tolerated and politically active smaller therapy.

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Political activity was observed in breast hadn't neck, and ovarian cancers with C.S. teaser nine.

We will be presenting update the data from phase one third tessellation for this agent ask in a couple of weeks.

In the fourth quarter of 2019, we a nasty initiation of a phase two expansion study of C.S. users or a night Mona therapy in patients with hormone receptor positive heard too negative breast cancer.

Seven mixed okay. Good minutes that every three weeks with your objective in rolling up to 40 patients.

Enrollment was initiated that patients were treated you in Q1, but regrettably the coated 19 situation, let us to temporarily pause you patient enrollment and new site activation in this study.

Sean A. McCarthy: CX2029 is a probody against CD71 conjugated to the cytotoxic payload MMAE. We recently announced the achievement of pre-specified dose escalation success criteria for the CX2029 Phase 1 Death Escalation Study, resulting in a $40 million milestone payment from AbbVie to CytomX. Data from this Phase 1 study will be the subject of an oral presentation at ASCO 2020. The CytomX and App-B teams are now actively finalizing plans for the initiation of Phase 2 expansions as soon as possible. CytomX has the responsibility for advancing this program through initial proof of concept, whereupon, if successful, the program will transition to AbbVie for registrational studies and ultimate commercialization. CytomX retains significant U.S. commercial rights to this asset and is also eligible to receive double-digit ex-U.S. royalties should the product reach the market.

Our team continues to closely monitored emerging health authority guidance I.R.B. Ethics Committee recommendations about goal is to resume the six to users are nine clinical program as soon as practical.

That staying with the theme of Undruggable target, it's I'd I'd like to turn to see X. two zero to nine A.C.D. 71 targeting probably body drug calms, you got that waste developing in partnership with Abby.

<unk> in Q1, we are nice the achievement of a major collaboration Boston.

Long considered a high potential, but druggable antibody drug culture, good target Cdseventy, one isn't it as a professional internalize are given his role of moving iron from the extra studied a space into interest I had a compartments.

It does this an old dividing cells in fact, many consider cdseventy wants to be the gold standard internalize or.

The in vitro activity.

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But the presence of Cdseventy normal cells, it's been an impediment to use as a drug target.

Sixties or a tonight is a pretty body I guess cdseventy one complicated to the side just tossing payload M.A.E.

We recently and I see a cheap, but a pre specified does escalations success criteria.

For the C.S. teaser Tonight phase one escalation study, resulting in a 40 million dollar Boston payment from I.V. two sites I mix.

Data from this phase one study will be the subject of an oral presentation Pascoe twentytwenty.

Besides that makes an I.P. themes or that actively finalizing plans for the initiation of phase two expansions as soon as possible.

Has the responsibility for advancing this program through initial proof of concept where upon is successful the program old transition to happy for Registrational studies and ultimate commercialization.

So I totally pertains significant U.S. commensurate rice to this asset and there's also eligible to receive double digit X.U.S. royalties should the product reached the market.

I'd I'd like to move to another unique or anti strategy that way for sitting assignments, which is to use our <unk> technology to generate first thing class agents against Undruggable targets in the context of T. cell engaging by specific antibodies, which I will refer to go for it S.P.C.B.'s.

Sean A. McCarthy: I'd now like to move to another unique R&D strategy that we're pursuing at CytomX, which is to use our ProBody technology to generate first-in-class agents against undruggable targets in the context of T cell engagement by specific antibodies, which I will refer to going forward as TCBs. TCBs are highly potent therapeutics that direct the activity of cytotoxic T-cells to tumors. This approach has the potential to take immunologically cold tumors and make them hot, opening many new avenues for cancer treatment. However, while clinical advances have been made with this approach in hematologic malignancies, notably with Amgen's CD19-CD3 bispecific blintz-nitrose, its application to solid tumors has been challenging. The reason for this is that the high potency of TCBs can target normal tissues with low antigen expression, resulting in significant toxicity.

P.C.D.'s are highly paid for 30 days, which directs the activity of sliced off the t. cells to tumors.

This approach has the potential to take immunologically cold tumors and make them hot opening many new avenues for cancer treatment.

Well <unk> clinical advances have been made with this approach in <unk>.

<unk> Cdnineteen C.D. three by specifically in size.

Location to solve it you must have been challenging.

Reason to this is the the high potency of P.C.B.'s could target normal tissues with low asking expression, resulting in significant toxicities.

For several years, we've been working at sites I'd like to research on optimized <unk> versions of the P.C.B.'s.

Sean A. McCarthy: For several years, we've been working at CytomX to research and optimize pro-body or masked versions of TCBs with an initial focus on the EGFR-CD3 target pair. Data published by others have shown that EGFR, whilst a well-validated oncology target, is unruggable in the context of a CD3 bispecific, a conventional CD3 bispecific. Our published preclinical findings have shown that pro-body TCBs against EGFR could induce tumor regressions and create a therapeutic window for this cancer target. These important findings serve as the foundation for our ongoing collaboration with Angen, which I'll speak about in just a few moments.

Initial focus on the E.P.F.R.C.D. three target pair.

Data published by others to show that each F.R. wants to well validated oncology target is undruggable in the context of a C.D. three by specific conventional C.D. three by specific.

Published preclinical findings it shows the pro body T.T.V.'s against each F.R. couldn't use tumor regression was and creates a therapeutic window for this cancer target.

These important finding saved the foundation for our ongoing collaboration with engine, which I'll speak about in just a few violence.

Sean A. McCarthy: Building on our successful research on pro-body TCBs, during Q1, we announced a major strategic collaboration in this area with Astellan. Under this new agreement, CytomX and Astatus will collaborate on four initial programs focused on the discovery, research, development, and commercialization of pro-body TCBs targeting undisclosed tumor attitudes for the treatment of cancer. CytomX will lead early drug discovery activities, with Astellas leading preclinical and clinical development and commercialization activities. Under the terms of the agreement, CytomX received an $80 million upfront payment and is eligible to receive future preclinical, clinical, and commercial milestones of over $1.6 billion, together with tiered royalties on product sales that range from high single digits into the mid-teens. For certain targets, CytomX may co-fund a pre-determined portion of product development costs and become eligible to receive a pre-specified portion of profits in the United States.

Building when I was successful research on probably body T.C.B.'s drinking water when asked the major strategic collaboration in this area with a status.

Under this new agreement.

That is what collaborate on for initial programs focus on the discovery research development on commercialization <unk> T.C.B.'s targeting undisclosed cheaper options for the treatment of cancer.

So I typically early but discovery activities with a status, leading preclinical clinical development and commercialization activities.

Under the terms of the agreement sites that mix received an $80 billion upfront payment and is eligible to receive future preclinical clinical unconditional milestones at $1.6 billion together with tears loyalties on product sales that range from high single digits.

Teams.

For certain target sites that makes me cofide predetermined portion of product development costs as big companies that I'm become eligible to receive a pre specified portion of profits in the United States.

Sean A. McCarthy: CytomX may also later elect to co-commercialize products directed towards such targets in the U.S. Research work in the collaboration is underway, and we are thrilled to have Astellas as our newest partner. Returning now to our Amgen partnership, I'm also delighted to report that we have recently advanced a lead pro-body TCB candidate against EGFR, which we call CX904, into IND-enabling studies. This is the first pro-TCB video from our platform to reach this important landmark.

I also later likes to Cook commercialize products directed towards such targets in the U.S.

Research work in the collaboration is underway and we are thrilled to to have a status I was on U.S. partner.

Pretending that as far as that partnership I'm also delighted to report that we have recently it bounced a lead probably body T.C.B. candidate against each F.R. that we call C.X. 904 into I.N.D., enabling studies. This is the first Crow T.C.B. from our platform to reach this important like Mark.

Sean A. McCarthy: CytomX is responsible for the IND filing, which is targeted for late 2021 and for early clinical development. We're very pleased with this excellent scientific progress within our Amgen Alliance and with the growing excitement around the potential of the pro-body TCB space, as also evidenced by our new partnership with Estella. Moving now to our potential best-in-class programs, CX072, our wholly-owned anti-PD-L1 pro-body, and BMS 986249, the anti-CTLA-4 pro-body partnered with Bristol-Myers Squibb. CX072 was the first pro-body we advanced into the clinic, and it has provided us with crucial insights and the first clinical proof of concept for our platform. We will be presenting In Q1, as part of a portfolio reprioritization, we announced the termination of the Phase 2 program, combining CX072 with ipilimumab, the anti-CTI-4 antibody, in patients with relapsed or refractory melanoma. This decision followed a reevaluation of the evolving clinical, competitive, and commercial landscape in immuno-oncology, taken together with the impact We continue to evaluate opportunities for the further advancement of the CX-072 program, and we plan to initiate combination studies with our second wholly-owned program, CX-2009, later this year.

Is responsible for I., Andy filing, which is targeted for late 2021 and for early clinical development. We're very pleased with this excellent scientific progress within our am generalize and with the growing excitement around the potential of the pro body T.C.B. space as also evidence biology partnership with this stuff.

Moving out to our potential besting costs programs see so seven to hold the R.C.P., one pro body and P.N.S. Nite X. six to 49.

He's got like four property parted with personal by a square.

Six or seven to was the first <unk>.

Provided us with crucial insights and the first clinical proof of concept for our platform.

We'll be presenting long term follow about things that from the six or seven two phase one to study I was an old presentation ask us.

And Q. and as part of a portfolio Reprioritization, we had asked determination of the states to program.

Binding six or seven to leave it mapped down to see to like for anybody in patients with relapse door refractory melanoma.

This decision falling to re evaluation of the evolving clinical competitive and commercial landscaping immunooncology taken together with impact of the covered 19 pandemic.

We continue to evaluate opportunities for the further advancement with the six or seven to program and we plan to initiate combination studies with our second Holy I'm pretty bad see X. two stores or nine later this year.

During the one we also have an acid important pipeline milestones at our foundational oncology collaboration with B.M.S.

The leading edge of this alliances the I.D.C.T. like fall prey body B.M.S. 96 to 49.

C.C.L.A. for the target balloon that is the prototypical checkpoint target I'm blocking this mechanism as crude highly effective in the treatment of patience with melanoma and other cats are types.

Monotherapies and in combination with P.D. pathway temperatures.

What a very important that box seats, you like four blockade can cause severe and you can relate to toxicities.

Creating a clear opportunity for pro 40 version of this agent to improve Tolerability.

Increase duration of treatment and potentially improve activity.

B.M.S. insights that makes it previously presented preclinical proof of concept for C.P.L.A. four <unk> several major research conferences and phase one clinical data for this probably body will be presented Oscar.

Based on these phase one findings B.M.S. recently initiated a randomized space to expansion study comparing the tolerability at activity at the N.S. 96, 2.9, plus they have all of that to it'd be plus nivo in front line, but just I think by the number.

The advancement of D.C.C. <unk> into this study triggered a milestone payment of $10 million from P.M.S. two sites are nice.

Sean A. McCarthy: During Q1, we also announced an important pipeline milestone in our foundational oncology collaboration with BMS. The leading edge of this alliance is the anti-CTLA-4 pro-body, BMS-986249. CTLA-4, the target of ipilimumab, is the prototypical checkpoint target, and blocking this mechanism has proven highly effective in the treatment of patients with melanoma and other cancer types, both as monotherapy and in combination with PD pathway inhibitors. While a very important advance, CTLA-4 blockade can cause severe immune-related toxicities, creating a clear opportunity for a pro-body version of this agent to BMS and CytomX have previously presented preclinical proof of concept for CTLA-4 probodies at several major research conferences, and Phase I clinical data for this probody will be presented at ASCO.

This is an important study that if positive has the potential to place the it believe about property owner Registrational pass.

<unk>. This work as a terrific example of what we set out to do with our platform. When it was first conceived off and we're excited about his potential for cancer patients.

Additional recent progress within our P.N.S. Alliance includes the initiation off the jokes escalation phase off another clinical study phase one to study for a second antsy seats <unk>, we call. This B.M.S. 96 to eight eight.

This is based on a modified version of it'd be.

The second clinical probably 40 program demonstrates B.M.S. ongoing commitment to our technology platform as a way to potentially underdog additional value in the C.C. four mechanism and across other targets.

Before I hadn't even if it's a Carlos I want to also nice that we continue to strengthen our executive leadership, such I mix and with the appointments and Q1 off Carlos I.C.I. folk I'd also talk to us and had a as chief Medical officer cost analysis and bring each spring over 30 years of leadership experience from across their respective the names. So we absolutely delighted.

So welcome them to the team I.

What Alex to the Cold I would briefly to call us.

Thanks for fun I'm very pleased to be here.

I'd like you are you the financial highlights or the first quarter ending March 31st 2020.

And a quarter with $50 million compared to 29 90 minute corresponding period in 2000 and I can.

Increases primarily due to the park and rubbing your recognition of the 40 million milestone I'm from and the associated with it Yeah 2029 project.

Nine related to the my sound on from B.M.X. associated with the initiation <unk> to rent at my home or an extension of B.M.X. 96 Q4 nine.

Sean A. McCarthy: Based on these Phase 1 findings, BMS recently initiated a randomized Phase 2 expansion study comparing the tolerability and activity of BMS-986249 plus nivolumab to IPI plus nevo in frontline metastatic melanoma. The advancement of the CCLA4 ProBody into this study triggered a milestone payment of $10 million from BMS to CytomX. This is an important study that, if positive, has the potential to place the ipilimumab probody on a registrational path. Moreover, this work is a terrific example of what we set out to do with our platform when it was first conceived of, and we're excited about its potential for cancer patients. Additional recent progress within our BMS Alliance includes the initiation of the dose escalation phase of another clinical study, a Phase I-II study for a second anti-CTLA-4 pro-body. We call this BMS 986288, and it is based on a modified version of IPI.

Research and development offensive or $43 million for the quarter compared to 30 million in the corresponding period, each 1009 rooms.

The increase is likely to target. It can lifelong friends have license fees associated with milestones nonstop paint on the first <unk>.

<unk> administrative expenses were flat compared to the corresponding Peter period.

Hmm.

We ended the corner with cats cats equivalent.

One $247.9 million compared to 289.1.

December 31st you're talking on routine.

<unk> <unk> <unk>, an existing and new partnerships. During Q1 have resulted in $130 million in my town and upfront payments just like that are not reflected in our end of Q1 possible.

I would like to underscore the company continues trunk track record that strategic business development transactions to broaden our pipeline and access additional nondilutive heartbreaking.

We expect are strong balance sheet trial hours, you're comfortable you meet projected operating requirement into the second half on 2022.

No new collaboration or <unk>.

What's that I'll try to call back to Sean.

Great. Thanks, Carlos so to wrap up sites that I've had a very strong first quarter of 2020 with many key achievements across our preclinical in clinical programs.

Partnerships and in the formation of that nature do strategic Alliance, we have a strong balance sheet to advance our pipeline and whether markets uncertainty and we're looking forward to ask I I wish we have multiple presentations that will provide important updates on all of our technical stage programs I'm very proud of the sometime next team for staying intensely focused in these challenging times as we drive.

Towards making the biggest difference we can for patients with cancer. So thankful for your time today, we wish the very best to to you and your families.

Chris Please now open to call up to question.

Operated we'll take our first question.

Sean A. McCarthy: This second clinical pro-body program demonstrates BMS' ongoing commitment to our technology platform as a way to potentially unlock additional value in the CTLA-4 mechanism and across other targets. Before handing it over to Carlos, I want to also note that we continue to strengthen our executive leadership at CytomX with the appointments in Q1 of Carlos as CFO and also Dr. Allison Hanna as Chief Medical Officer. Carlos and Allison each bring over 30 years of leadership experience across their respective domains, and we are absolutely delighted to welcome them to the team. I would now like to turn the call over briefly to Carlos.

Thank you as a reminder to ask a question you know me depressed star one on your telephone 20 try your question you press the pound or hash ski I first question comes from Peter Lawson with Barclays. Your line is now okay.

Mm.

Peter are you there.

Operated we can move onto the next question.

Oh, Okay. Our next question.

Comes from Peter Mariah <unk> instruments.

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Oh, It can't hear me Okay, yes.

The beginning you came on halfway.

Okay, I'm, sorry about that so what what I'm interested in top 16 year round C.D. 166 program person says P.D. 71, just curious about the pain loads being used up here and the internalization profiles of the targets <unk>.

Given that see east haven't D., one is very efficient and then turn the lighting did that in pack. The type of payload that you chose to use I noticed that you two different payloads for these products also for the C.D. 71, T.D.C. I'm curious about what.

Carlos Campos: Thank you, Sean. I'm very pleased to be here.

Carlos Campos: I'd like to review the financial highlights for the first quarter ending March 31, 2020. Revenue for the quarter was $50 million compared to $29 million in the corresponding period in 2019. The increase is primarily due to the partial revenue recognition of the $40 million milestone earned from AVI associated with the CX2029 project, and $10 million related to the milestone earned from BMS associated with the initiation of the Phase II randomized cohort extension of BMS 986249. Research and development expenses were $43 million for the quarter, compared to $36 million in the corresponding period in 2019. The increase was largely attributed to license and sub-license fees associated with milestones and upfront payments earned in the first quarter of 2020. General and administrative expenses were flat compared to the corresponding period in 2019.

Some expected on target toxicity, it might look like birthdays toxicity due to the payload in general Pinkie.

Yes, thanks for the questions. So first of all with regards to the payloads, yeah going back several years when we designed the <unk> strategy. We made it very conscious decision for the first two <unk> gets to take into the clinic that we would work with the the most established.

Warheads, so payloads, if you like and D.M. four was selected for the C.D. 166 program through an alliance with Immunogens, an M.A.E., which at the time with the second most validated payload we were able to access that through our alliance with would that be via their lives with Seattle genetics and so.

Frankly, we could've used it could have ended up being the other way around that's just the way. They played out at the time, we consider those to pay less to be the most and best validate that at that time in terms of the toxicities with them for you know we've we've we've known for a long time that the principal toxicity with them for his ocular talks.

What we saw the higher doses escalation in phase one is something that is manageable in the form of Oh killer parental access. So that's something that we're implementing in the the ongoing face to study.

With regard to C.D. 71, and and then they eat the principal toxicity.

Different T.M. for that more human Silajdzic in nature, that's what we saw in our pre clinical studies and I seem intelligent toxicities that we're looking out for in the clinic.

Carlos Campos: We ended the quarter with cash, cash equivalents, and investments totaling $247.9 million, compared to $296.1 million as of December 31, 2019. Our achievements in existing and new partnerships during Q1 have resulted in $130 million in milestone and upfront payments to CytomX that are not reflected in our end-of-Q1 cash balance. I would like to underscore the company's continued strong track record of executing strategic business development transactions to broaden our pipeline and access additional non-dilutive operating systems. We expect our strong balance sheet to allow us to comfortably meet projected upgrading requirements into the second half of 2022, assuming no new collaborations or findings. With that, I'll turn the call back to Sean.

With regard to C.D. 72 on on target toxicity, it's very difficult to say you know we we.

C.D. 166.

Just just as an example.

The target is expressed on most normal tissues and you could afford for that you may see toxicity of any kind in fact in the clear that we really didn't see any evidence of on target toxicity with all reported data on C.D. 166 will provide the data on C.D. 71 phase one does escalation.

In a couple of weeks I ask.

Great.

Thank you.

Thank you I next question comes from parents, playing with Goldman Sachs. Your line is now open.

Mm.

Thanks for taking the questions maybe just a following up on two zero to nine based on the animal data is there any reason to think that the activity would be more robust and lymphoma, let's say relative to the solid tumors setting and then can you remind us in the phase one trial, if you only enrolled patients that had high level.

C.D. one expression was that a cut off or are you going to look at that perspective way now when we see the debt Pascoe. Thank you.

Yeah I turned thanks to the questions I'll take the second question first patients were not pre selected for high target levels in the study.

It is something where they can got <unk> retrospectively of course I'm with regard to.

Lymphoma, the phase one there's escalation has allowed us to enroll solid tumors that I live in farmer, we'll ever see a report that patient population. When we presented the data the pre clinical work was mostly fall mostly focused on the <unk> site.

Sean A. McCarthy: Great, thanks, Carlos. So to wrap up, CytomX had a very strong first quarter of 2020 with many key achievements across our preclinical and clinical programs, in our existing partnerships, and in the formation of a major new strategic alliance. We have a strong balance sheet to advance our pipeline and weather market uncertainty, and we're looking forward to ASCO, at which we have multiple presentations that will provide important updates on all of our clinical stage programs. I am very proud of the CytomX team for staying intensely focused in these challenging times as we drive towards making the biggest difference we can for patients with cancer. So thank you all for your time today. We wish the very best to you and your families. And Chris, please open the call up to questions now.

Thanks.

Thank you are next question I was from Robert Burns like H.C. Wainwright. Your line is now open.

Hi, guys. Thanks for taking my questions and congratulate a quarter just two questions.

So the first one is can you provide somebody just sort of colors did he indication you're considering exploring the phase two expansion baseline on the data you've seen for C.N.X.T. zero to nine my second question is similar to what you did first see X. two 009 in with regards to pre clinical assessments combining it with.

Oh seven to have you for Warren and he preclinical assessments evaluating potential Sandra for six 0072, plus C.X. two zero to nine and if so are you planning on in Valuating that combination in the clinic.

<unk>.

Yeah, Alright rubber thanks, great questions.

Not prepared a already to comment on phase two indications at this stage put 2029, but of course, they will be guided by Oh everything that we note to this point with regard to the combination.

Operator: Operator, we'll take our first question. Thank you.

As you as you rightly points that we have.

We previously reported preclinical data at A.C.R. last year, showing the potential for.

Operator: As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound or hash key. Our first question comes from Peter Lawson on Barclays. Your line is now open.

C.D. wants 66.

<unk>.

Synergize with P.D., one P.D.L. one that work underpins are ongoing strategy to move into the combination of 2000, I don't know seven to which is which is plan for later this year.

With regards to choose or Tonight is too ready to say, but as another drug <unk>. It certainly makes conceptual sense that that could be combined with a P.D. agent of one kind or another but we don't have anything more to say about that at this time.

Operator: Peter, are you there? Operator, we can move on to the next question. Okay, our next question comes from Peter Mirai with Nomura Instruments on CD-166. Oh, can you hear me okay? Yes, sir. You were muted in the beginning.

Alright. Thanks.

Mmm.

Thank you are next question comes from Peter Lawson with Barclays airline is how open.

Hi, there this is mitchell onto P. or can you guys hear me now.

Yes, yeah, Okay, sorry, I had to read out when I don't know what happened. So I had a couple of questions regarding the first one is for your C.D. 71 day that ASKO, what kind of data might we see how many patients and how might that change from the abstract to the time the presentation.

Operator: Okay, I'm

Operator: about that. So what I'm interested in...

Sean A. McCarthy: I'm just curious about the payloads being used here and the internalization profiles of the targets. Given that CD71 is very efficient in internalizing, did that impact the type of payload that you chose to use? I noticed that you used two different payloads for these products. Also, for the CD71 PDC, I'm curious about what some expected on-target toxicities might look like versus toxicities due to the payload in general. Thank you

Very not able to comment on that right now abstract will be published I guess next week and.

In a position to provide some additional guidance at that point, but not much more we can say at this point I'm sorry to say.

Understood and then just wanted to ask about How're you guys are thinking about data release in in a virtual World. Then you know what that changes in terms of condition engage man and dialogue and things like that.

We are going to do the very best weekend.

Got it.

I think we're still.

Sean A. McCarthy: Yes, thanks for the questions. So, first of all, with regard to the payloads, you know, going back several years when we designed the pro-body drug conjugate strategy, we made a very conscious decision for the first two pro-body drug conjugates to take into the clinic that we would work with the most established warheads or payloads, if you like. And DM4 was selected for the CD166 program through an alliance with Immunogen. And MMAE, which at the time was the second most validated payload, we were able to access that through our alliance with AbbVie via their alliance with Seattle Genetics. Frankly, it could have ended up being the other way around; that's just the way it played out at the time.

No seriously where was I think we're all still learning to some extent yeah, what the what the final processes going to be so, but yeah <unk>.

We kind of will make us I was available.

Thoughts or a questions as well.

Great. Thank you.

Thank you I next question comes from.

Oh I speak out with calendar airline is open.

[noise], Great can you hear me gosh.

Yes, we got right I send my first question on 2000, a the times and nine study. That's currently on hold just curious in terms of patients that are enrolled in the study how consistent are these patients going through their follow ups interest you know what a potential concerns about data quality, if they start I'm missing so they're appointments.

Yeah, I bars, I mean, I think that's it that's the question that relates to everyone right. In this in this moment in time and don't have anything.

Anything specific to say about that other than that is a risk of course, that's patients that have been on study you know may have child, just getting back into.

Sean A. McCarthy: We considered those two payloads to be the most and best validated at that time. In terms of the toxicities with DM4, we've known for a long time that the principal toxicity with DM4 is oculotox. That's exactly what we saw at the higher doses, and our dose escalation in phase one is something that is manageable in the form of ocular prophylaxis, but that's something that we're implementing in the ongoing phase two study. With regard to CD71 and MMAE, the principal toxicities of MMAE are a little bit different from DM4. They're more hematologic in nature, and that's what we saw in our preclinical studies, and it's hematologic toxicities that we're looking out for in the clinic. With regard to CD71 on-target toxicity, it's very difficult to say, with CD166, just as an example. The target is expressed in most normal tissues, and you could therefore infer that you may see toxicity of any kind. In fact, in the clinic, we really didn't see any evidence of on-target toxicity with our reported data on CD166. We'll provide data on CD71, phase one dose escalation, in a couple of weeks at AFCA.

The sensors that we're still being treated we're we're still in the recipe early stages of figuring out what the impact is going to be I.

I guess I'll, let me just follow up on it because some questions from that funny Masters are these patients going to hospitals for follow up or these <unk> outpatient setting.

I don't want to comment on that specifically bars at this point, but it's going to be a combination of those.

Gotcha and maybe on my last question is for the 2009.

Can you set expectations for data presentation presentation, or ASKO, specifically, what should investors be focused on.

Where's that was that was to zero to nine.

Yeah, No two zero.

Yeah.

Yes, so so tracking back to last year or a C.R. that was the last day to update the phase one 2009 work.

So this is this will be the first update and it effectively if the completion of the phase one study for C.S. users are annoying confused with the does escalation. So it was gonna be additional follow up is going to be additional patients. Most importantly data.

That with the data that supports our advancements have two 009 into.

<unk> supposedly pursued negative breast cancer <unk>. So the data should make it clearer to investors <unk> underpinned that decision clearer than the data set that was presented a year ago.

Operator: Great, looking forward to it. Thank you. Thank you. Our next question comes from Terrence Flynn with Goldman Sachs. Your line is now open.

Gotcha. Okay. Thank you very much I think my question.

You're welcome thicker.

Thank you I next question comes from Mara Goldstein with <unk> airline is now open.

Thanks, very much for taking the question I have two questions want us to just a clarification on a cash runway I I do we headed doesn't include any other partnerships speaking to think anticipate any other milestones family existing programs that you already have including any resources that you make use to find programs.

Operator: Thanks for taking the questions. Maybe just following up on 2029, based on the animal data, is there any reason to think that the activity would be more robust in lymphoma, let's say, relative to the solid tumor setting? And then can you remind us, in the Phase I trial, if you only enrolled patients that had high levels of CD1 expression, was that a cutoff, or are you going to look at that prospectively now when we see the data at ASCO? Thank you.

It's the first and then also I'm, hoping that you might be able to just provide an update on that B.I.B.M.S. collaboration. Currently you have candidates that are advancing but my parents you. The M.S. has that option for additional targets and are there any timeline our constraints around.

I guess, how much more might come back to you.

Yeah, <unk> so regarding cash runway all comment then oh, maybe they want to jump into but.

Sean A. McCarthy: Hi Terrence, thanks for the questions. I'll take the second question first.

We always make very conservative assumptions around milestones from existing deals so well that may be.

Sean A. McCarthy: Patients were not pre-selected for high target levels in the study, but that is something we're looking at retrospectively, of course. And with regard to lymphoma, the Phase I dose escalation has allowed us to enroll solid tumors and lymphoma patients, and we'll obviously report the patient population when we present the data. The preclinical work was mostly focused on the solid tumor side of things.

Element of milestones factored into that runway guidance is going to be pretty conservative now that said.

You have a pretty good track record of earning milestones in these deals as I as I'm sure you'll agree. So you know, but we but we are but we are.

For guidance purposes pretty conservative.

Carlos anything to add to that.

No nothing time.

Great and then regarding B.M.S., yes, you're right are they do he turned back to the expansion that we did a few years ago. They they still do you have the ability to select additional targets, we haven't disclosed timeline or under which they need to discuss to select those target.

But you know if they don't have forever.

Operator: Thank you. Our next question comes from Robert Burns with HC Wainwright. Your line is now open. Hi guys.

There was a backs up on that we're in we're at active dialog with that was too.

Additional target selections and getting additional programs up and running a which we're very excited to be.

Okay, and if I could just have one other question on 16 parents Sharon I'm in terms of you know that the child has been temporarily parked at at this point Yeah current environment back can you speak to how many patients actually began dosing when you're not trial.

Operator: Thanks for taking my questions and congrats on the quarter. Just two questions, if I may. So, the first one is, could you provide some additional color to the indications you're considering exploring in the Phase II expansion based on the data you've seen for CX2029? And my second question is, you know, similar to what you did for CX2009 with regard to preclinical assessments of combining it with CX072, have you performed any preclinical assessments evaluating potential synergy between CX072 plus CX20 And if so, are you planning on evaluating that combination in the clinic? Thank you.

No I really I already <unk>, but as I said, our goal is to get 40 patients enrolled into that study.

It is it so we really kind of sitcoms speak to how many patients have been a role.

But unfortunately now we can speak either too you know timing of data because it's just go so uncertain, but <unk>.

To to to to get that program back on track that'd be able to provide some clever.

<unk>.

Alright, Thank you I appreciate it.

Ticker.

Thank you I next question comes from <unk> <unk>, what's going on security is your line is okay.

Great. Thanks for taking one question. Most most has been answered vicious one or two popped a with a couple or questions here. So first well, Sean maybe four C. Expos seven to just wondering what's next for for for the for the P.D.O. One pro body. It what maybe we could learn from from the ask what presentation is.

As far as you know perspective sort of motto therapy, or maybe even other combinations beyond sort of a C.T.L.A. for a combination of <unk> and Carlos maybe if you can talk about the page so barn d. spend throughout the rest of 2020, you know to the extent that you can given given the the cube.

Sean A. McCarthy: Hi Robert. Thanks. Great questions. Not prepared or ready to comment on Phase 2 indications at this stage for 2029, but of course, they will be guided by everything that we know to this point. With regard to the combination... As you rightly point out, we have previously reported preclinical data at ACR last year showing the potential for CD166, ProBodyDrugConjugate, to synergize with PD-1 and PD-L1. And that work underpins our ongoing strategy to move into the combination of 2009 and 07-2, which is planned for later this year. But with regard to 2029, it's too early to say. But as another drug conjugate, it certainly makes conceptual sense that it could be combined with a PD agent of one kind or another. But we don't have anything more to say about that. All right, thanks.

One number thanks.

Yeah, Great, Hi, s. or so with regard to seven too.

The the.

After a presentation as I as I mentioned will be.

<unk> round out the the phase one.

The phase one to a work that we've done all the programs so far so you'll recall that.

The.

The program.

Advanced to enrollment of patients didn't see a number of <unk>.

Small expansion Cold war, so around 15 patients in a number of different <unk> some of which were.

Expected to be to respond to a check once in there, but there's some of which were a bit more speculative.

So the data I'll take one or therapy would include really the the brand that I have data and some fairly lengthy follow up on patients from the amount of therapy expansions.

<unk>.

In addition to you some yeah I don't think Oh me Oh me it'd be combination phase one does escalation in terms of.

In terms of where we go next with the program continues to be an active program. The company. We are to some extent shifting gears towards combinations with our own pipeline S.S. like two 009 and that said, we do continue to you.

Operator: Thank you. Our next question comes from Peter Lawson with Barclays. Your line is now open.

Talk to potential partners and we also continue to evaluate other emerging combination opportunities. So.

So there's.

Operator: Hi there, this is Mitchell on behalf of Peter. Can you hear me now? Yes. Okay. Sorry, I had to redial in. I don't know what happened. So, I had a couple of questions for you guys. The first one is about your CD71 data at ASCO. What kind of data might we see, how many patients, and how might that change from the abstract to the time of the presentation?

Plenty of that we could potentially doing the future, but right now the most immediate next step will be the combination with 2009 with the indication that to be to be disclosed late today.

Mm.

Creating a car Carlos good comment on the Sunday, Yeah, I, absolutely. So we're not biding fully are fine, but beyond our cat from like that we mentioned, but I do a one to point out and and then some.

Into formal remarks that you want included I carry them, one time like fences I, probably can't have less like like my father, then sub like that are related to the milestones and upfront payments that we during the quarter, so, but the fancy look I'd be like.

Sean A. McCarthy: We're really not able to comment on that right now. The abstract will be published, I guess, next week, and we may be in a position to provide some additional guidance at that point, but not much more we can say at this point, I'm sorry to say.

Great. Thank you and congratulate progress.

Okay.

I said I don't take care.

Thank you I next question comes from Joe Catkins are always hyper Sandler airline is how often.

Hey, guys I think for for taking my question here just maybe one quick one for me on on 2029, What'd you be able to detail. The the dose escalation scheme I use them. This study as it compared to to the 2009 dose escalation specifically were single patient.

Sean A. McCarthy: And then I just wanted to ask about how you guys are thinking about data release in a virtual world and, you know, what that changes in terms of physician engagement and dialogue and things like that.

Sean A. McCarthy: We are going to do the very best we can. Okay. Thank you. I think we're still... But seriously, I think we're all still learning, to some extent, what the final process is going to be. But yeah, we'll certainly do the very best we can, and we'll make ourselves available to answer questions as well.

Don't tessellation cohorts initially use where are you able to started a higher dose giving any learning.

From 2009 things along those lines. Thanks.

Yeah, Hey, Joe the only thing I would say as I believe I said previously on on this particular program is that we actually started at a pretty low does given the nature of the target.

Yeah C.D. 71.

Operator: Great, thank you. Thank you. Our next question comes from Boris Peeker with Cowan. Your line is open. Good. Can you hear me, guys?

Cds have doing is is this is this is a big idea and this is a tough tough targets tried drugs. So and we know from preclinical work that we've done that engaging cdseventy. One instead of August monkeys is is lethal at a quite low.

Operator: Yes, we can.

Operator: Great. So my first question on the 2009 study that's currently on hold: just curious, in terms of patients that are enrolled in the study, how consistent are these patients going through their follow-ups, and just, you know, what are the potential concerns about data quality if they start missing some of their appointments?

So so for various reasons, including those we we began does escalation I think it's.

Find just say out of lower does then 2009 I can't say anything more than that right now, but a lot of this will be shared at as being prepared to be shared that's a that's good.

Okay got a and maybe just one quick when I'm not sure. If you have any insight into this but the phase two randomize portion of the Bristol study would you happen to know if <unk>. If he does thing they're using it is consistent with checkmate 067, or a day sort of switched to the you know three costs, while I'm not they've used it.

Sean A. McCarthy: Yeah, hi, Boris. I mean, I think that's the question that relates to everyone, right, at this moment in time, and I don't have anything specific to say about that, other than that it is a risk, of course, that patients that have been on study, you know, may have challenges getting back into the centers at which they're being treated. We're still in the relatively early stages of figuring out what that impact is going to be.

Their studies.

Give any specifics there the the the dosing schedules there are five arms about study and it does.

<unk> schedules being evaluated.

Of course been informed by what was observed in the phase one dose escalation that data the phase one data will be presented by B.M.S. in post the form I ask and.

Sean A. McCarthy: I guess I'm going to just follow up on that because we've gotten some questions from the investors. Are these patients going to hospitals for follow-up, or are they in outpatient settings?

Will.

That's really all we can say right now about about the doses schedules that they're that they use it but the the the goal of course, if this program the masking if it'd be the goal mocking it'd be is too.

Sean A. McCarthy: I don't want to comment on that specifically, Boris, at this point, but it's going to be a combination of those.

Effectively give enough of this agent in the clinic to get to more effective how comes for patients and the <unk> schedules that they are moving forward in the phase two are consistent with that.

Operator: Gotcha, and maybe my last question is for the 2009 compound, can you set expectations for data presentation at ASCO, specifically what should investors be focused on?

Okay got it thanks, so much for taking my question.

<unk>.

Thank you. My next question comes from they'll keep in Salt Lake City Girl airline is open.

Yeah. Thanks.

Question, then collapse and all the problems that you have made this <unk> <unk> so <unk>.

Sean A. McCarthy: Boris, that was 2-0-2-9.

<unk> 209, if I remember correctly from the last day does that the activity was day, but the but there was little bit, though obviously salt safety. She was there, but but the the the the responses, but <unk> durable do the last update well did you have moving.

Operator: Yeah, no, two, zero, zero, nine.

Sean A. McCarthy: 2009 Yes, so tracking back to last year at AACR, that was the last data update on the Phase 1 2009 work. So this will be the first update, and effectively, the completion of the Phase 1 study for CX2009, the completion of the dose escalation. So there's going to be follow-up. There's going to be additional patients. Most importantly, the data that supports our advancement of 2009 into,

It'd be in in.

Yeah.

And it's up to the best kind of so.

Fair to assume that you have that goes to do that meeting you should have.

Yeah I'm of it so you're right to say that so the I A.C.R. as last year. So we propose it at that time seven seven unconfirmed P.R.'s.

And one of the you know one of the challenges at the time with the with the study was that.

Operator: Gotcha. Okay. Thank you very much for taking my questions.

We had no.

<unk> for good reason, we had no. It's a few days I'll kill approval access from the outset, because we really wanted to get a full view all these safety profile of the drug candidate well that meant was that the upper doses. The mid levels overdoses. Many patients came off patients were coming off.

Operator: You're welcome.

Operator: Take care.

Operator: Thank you. Our next question comes from Mara Goldstein with Mizuho. Your line is now open. Okay.

Operator: Thanks very much for taking the question. I have two questions. One is just a clarification on the cash runway. I believe you said it doesn't include any other partnerships, but does it anticipate any other milestones from the existing programs that you already have, including any resources that you may use to fund programs? Also, I'm hoping that you might be able to just provide an update on the BMS collaboration. Clearly, you have candidates that are advancing, but if memory serves you right, BMS has the option of additional targets, and are there any time limits or constraints around those targets in which they might come back to you?

Of course, the disease progression certain patients were coming off for I'll get a toxicity, so and that that is in large part why those responses a window ultimately confirmed so.

We do have additional experience with the drug candidate phase one that will be shattered pasco.

Coming up soon.

I didn't faze too.

We are actively mandating okay to profile axis and we've also picked it does seven makes the case, where we see political activity of course also where we are confident dolls color.

Mitigation can be effective so that this debate to study is set up to give us the best opportunity to keep patience on drugs for extended periods of time to really see what this struck out of that can do in a in a more focused.

Sean A. McCarthy: Yeah, hi, Mara. So regarding cash runway, I'll comment, and Carlos may want to jump in too. But we always make very conservative assumptions around milestones from existing deals. So while there may be some https://www.youtube.com.uk for guidance purposes, pretty conservative. Carlos, anything to add to that?

Let's have any pretreated patient population.

<unk> tried it and then one other question on on the other C.D. 71 program since F.B. has opted for the <unk>.

Okay for the program is it.

He was just comment on the criteria behind the my son payment then what what what kind of data they had to see fun, but.

But then do actually move followed the program.

Obviously, the the mouse that is a significant milestone under 40 billion dollar payment.

Carlos Campos: No, nothing to add.

That most of them is intended to you.

Sean A. McCarthy: And then regarding VMS, yes, you're right, Mara, they do, going back to the expansion that we did a few years ago, they still have the ability to select additional targets. We haven't disclosed the timeline under which they need to select those targets, but, you know, if they don't have forever, there is a backstop on that. And we're in active dialogue with them as to additional target selections and getting additional programs up and running, which we're very excited to do.

Fund the ongoing work that we'll be doing as we run the clinical program and move into the expansion course in terms of the criteria that triggered the mouse there is that what we call the dose escalation criteria that were specified at the time that we put the agreements in place a few years ago.

And while those criteria have not been disclosed.

Essentially they are they are they were designed to mark the completion of phase one.

Successful completion of based one does escalation supporting the weights that they used to expansions intellectual type a specific does so that's what we needed to achieve and that's that's why the most interesting.

Operator: Okay, and if I could just ask one other question about CX2009 in terms of, you know, the trial has been temporarily paused at this point due to the current environment, but can you speak to how many patients actually began dosing within that trial?

Awesome. Thank you very much on any appreciate it.

Hello.

Thank you are next question comes from Byron Jeffries Caroline is open.

Yeah, Hi, guys. Thanks to take my questions, maybe if I can just start on two zero to nine Sean.

Sean A. McCarthy: No, I really can't. But as I said, our goal is to get 40 patients enrolled in that study. We really can't speak to how many patients have been enrolled. And unfortunately, now, we can't speak either to the timing of data because it's just become so uncertain, but we're doing everything we can to get that program back on track and be able to provide some clearer guidance in the future. All right.

On controls, but if you if I look at the exclusion criteria for the phase one to trial.

It seems to be some criterion related to iron metabolism disorders and use of buying accumulators. So maybe he just talk about proceeding want part again, how it interferes with unions regulators.

Well see 71 is.

By definition the transfer in Recenter, the transferred receptive functions to internalize iron complex to transplant transfer and and get our and into a into dividing cells. So it's it's a fundamental.

Operator: All right. Thank you. I appreciate it. Take care.

Is a fundamental.

Component of iron metabolism, and so that was something that was done.

Operator: Thank you. The next question comes from Ezra Darut with Guggenheim Securities. Your line is open. Great. Thanks for taking my questions. Most have been answered, but I just wanted to pop in with a couple of questions here. So, first, Sean, maybe for CX072, just wondering what, Next, for the PD-L1 ProBody, and what maybe we could learn from the ASCO presentation as far as, you know, perspective on monotherapy or maybe even other combinations beyond sort of a CTLA-4 combination for that aspect. And Carlos, maybe if you could talk about the pace of R&D spend throughout the rest of 2020, you know, to the extent that you Thanks.

As a precautionary measure.

In phase one not knowing what we would see in the clinic. So that's pretty old we can say about that.

Okay, and then I guess in the Snow study if I look at that data from a few years ago. I think you tested two zero to nine along with some other pro body math antibodies and I think the the reason to choose to zero to nine.

Is that the other saw some weight loss huh. So I guess my question is how well do you think the lack of weight loss and say knows with.

Tonight translates into human study given I think that's in a model those are the animals twice or three weeks apart.

So do you think there there might be safety issues that may arise in patients receiving you know several cycles of therapy.

I must admit I'm not exactly sure what data you're referring to their.

Maybe we can take that off line, what I would say is that that's the center data that we have.

For the most part discussed.

There are two though two components at one is we demonstrated.

Sean A. McCarthy: Yeah, great. Hi Ezra.

Pretty convincingly that in a head to head comparison of antibody drug <unk> that.

Sean A. McCarthy: So with regard to 072, the ASCO presentation, as I mentioned, really will round out the phase one, the Phase 1-2a work that we've done on the program so far. So you'll recall that the program, um..., advanced to enrolment of patients into a number of small expansion cohorts of around 15 patients in a number of different tumor types, some of which were expected to respond to a checkpoint inhibitor, some of which were a bit more speculative. So the data update for monotherapy will include really rounded-out data and some fairly lengthy follow-up on patients from the monotherapy expansion. In addition to an update on the IPI combination phase one dose escalation, in terms of where we go next with the program, it continues to be an active program at the company. We are, to some extent, shifting gears towards combinations with our own pipeline assets like 2009, and that said, we do continue to talk to potential partners, and we also continue to evaluate other emerging combination opportunities. So there's plenty that we could potentially do in the future, but right now, the most important thing

The if you take you to fill count as a surrogate of human human subject talks that in in the in the unbiased.

Version.

That is very toxic molecule in scenarios with new to build cams plummeting, an animal's not surviving so much more than a week, whereas with the pro body you to go counts do do fine and so then <unk> cause I mentioned on earlier on the call. The principal him the principal toxicity from M.E.

Would be expected to be hematologic. So so that those experiments if they're very important in showing the masking in pre clinical studies.

Has the potential to open a therapeutic window for the target. We did present an update on data will day D.C. in London earlier this year I don't set up they including some of the the Nonclinical studies looking at talks and send it when a bit more detail, which which again emphasize.

Is that the principal toxicities, instead of R. and D.P.M., it's a logic I'm not sure what they do you were referring to see regarding weight loss, we should maybe look at that off line.

Okay, I mean, we can certainly.

<unk>, we enter today when we talk.

And and I guess, you know I have a last question separate program.

On the each year far.

You know dying D. filing at the end of 2021 can you just talk about whether you're pursuing t. 790 mutations with without program.

I <unk> I can't talk about that at this point.

Sean A. McCarthy: and on the R&D.

Carlos Campos: Yes, absolutely. We're not guiding for your fund, but beyond our cash runway that we mentioned. But I do want to point out, as I mentioned during the formal remarks, that Q1 included a series of one-time expenses associated with licenses and sub-licenses that are related to the milestones and up-front payments that we earned during the quarter.

Okay alright, thank you.

Tick ever.

Oh, and I'm not showing any further questions about this time I wouldn't I like to turn to call back to management for any closing remarks.

Great. Thanks, very much well just to just to summarize again it was very strong quarter for the company. Despite the the Mac or environments, and we look forward to catching up with only be guys next quarter take care.

[noise], ladies and gentlemen discount clear today's conference call. Thank you for participating you may now disconnect.

[music].

Carlos Campos: So, that's the extent of the guidance I can give you. Okay. Thank you, and congrats on the progress. Thank you. Thanks a lot. Take care. Our next question comes from Joe Catanzaro with Piper Sandler. Your line is now open. Hey guys. Thanks for taking my question here. Just maybe one quick one for me in 2029.

Operator: Would you be able to detail the dose escalation schema used in this study as it compares to the 2009 dose escalation specifically? Were single patient dose escalation cohorts initially used? Were you able to start at a higher dose, giving any learning from 2009, things along those lines.

Sean A. McCarthy: Yeah, hey, Joe. The only thing I would say, as I believe I said previously on this particular program, is that we actually started at a pretty low dose, given the nature of the target, CD71. CD71 is a big idea, and this is a tough target to try and drug, and we know from preclinical work that we've done that engaging CD71 in Psytomologous monkeys is lethal at quite So for various reasons, including those, we began dose escalation at a lower dose than in 2009. I can't say anything more than that right now, but a lot of this will be shared and is being prepared to be shared at ASCO.

[music].

Operator: Okay, I got it. And maybe just one quick one.

Sean A. McCarthy: I'm not sure if you have any insight into this, but the phase two randomized portion of the Bristol study, would you happen to know if the nevo-iffy dosing they're using is consistent with checkmate 067, or have they sort of switched to the, you know, 3 plus 1 that they've used in other studies?

Sean A. McCarthy: I can't give any specifics there. The dosing and schedules, there are five arms in that study, and the doses and schedules being evaluated have, of course, been informed by what was observed in the phase 1 dose escalation. That data, the phase 1 data, will be presented by BMS in poster form at ASCO, and that's really all we can say right now about the doses and schedules that they're using. But the goal, of course, of this program, the masking of IPI, the goal of masking IPI is to... They effectively give enough of this agent in the clinic to get to more effective outcomes for patients, and the doses and schedules that they are moving forward in phase 2 are consistent with that.

Operator: Okay, I got it. Thanks so much for taking my questions. You're welcome. Thank you. Our next question comes from Mohit Bansal with Citigroup. Your line is open. Great. Thanks for taking my question and congrats on all the progress you have made this quarter and last quarter as well. So, a couple of questions from my side. So, in 2009, if I remember correctly from the last data set, the activity was there, but there was a little bit of, obviously, safety issues were there, but the responses were not durable until the last update. Now that you are moving with the monotherapy arm in a subset of breast cancer, is it fair to assume that you have tackled the durability issue here?

Sean A. McCarthy: You're right to say that as of AACR last year, we reported at that time seven unconfirmed PRs. One of the challenges at the time with the study was that we had not. For good reason, we had not instituted ocular prophylaxis from the outset because we really wanted to get a full view of the safety profile of the drug candidate. What that meant was that at the higher doses, the mid-level to upper doses, many patients came off; patients were coming off, of course, with disease progression, certain patients were coming off for ocular toxicity, and that is, in large part, why those responses So we do have additional experience with the drug candidate now in phase one, and that will be shared at PASCO, coming up soon. And in phase two, we are actively mandating ocular prophylaxis, and we've also picked a dose, seven migs per gig, where we see clinical activity, of course.

Sean A. McCarthy: and the ocular mitigation can be effective. So the phase two study is set up to give us the best opportunity to keep patients on the drug for extended periods of time to really see what this drug candidate can do in a more focused, less heavily pre-treated patient population.

Sean A. McCarthy: Got it. And then one other question on the CD71 program. Since FD has opted in for the program, is it, so can you just comment on the criteria behind the milestone payment and what went into it, what kind of data they had to see for them to actually move forward with the program?

Sean A. McCarthy: Obviously, the milestone is a significant milestone, the $40 million payment. That milestone is intended to fund the ongoing work that we'll be doing as we run the clinical program and move into expansion cohorts. In terms of the criteria that trigger the milestone, they're what we call the dose escalation criteria that were specified at the time that we put the agreement in place a few years ago. And while those criteria have not been disclosed, essentially, they are: successful completion of Phase I dose escalation to point the way to Phase II expansions in select tumor types at a specific dose. So that's what we needed to achieve, and that's why the milestone was set.

Operator: Awesome. Thank you very much, Sean. I really appreciate it.

Operator: You're welcome.

Operator: You are next, and Byron Aneen with Jefferies, your line is open. Yeah, hi guys. Thanks for taking my questions. Maybe if I could just start in 2029, Sean.

[music].

Sean A. McCarthy: On clintrials.gov, if I look at the exclusion criteria for the Phase 1-2 trial, there seem to be some criteria related to iron metabolism disorders and the use of iron chelators. So maybe you can just talk about the CD1 target and how it interferes with anemias or chelators.

Sean A. McCarthy: Well, CD721 is, um, uh... By definition, the transferrin receptor functions to internalize iron complexes to transferrin and get iron into dividing cells. So it's a fundamental, is a fundamental component of iron metabolism. And so that was something that was done as a precautionary measure in phase one, really not knowing what we would see in the clinic. So that's really all we can say about that.

Sean A. McCarthy: And then I guess in the CINO study, if I look at that data from a few years ago, I think you tested 2029 along with some other pro-body mass antibodies. And I think the reason you chose 2029 is that the other compounds saw some weight loss. So, I guess my question is, how well do you think the lack of weight loss in SINOs with 2029 translates into human studies, given, I think, that the SINO model treats the animals twice at three weeks apart, and so do you think there might be safety issues that may arise in patients receiving, you know, several cycles of therapy?

Sean A. McCarthy: I must admit, I'm not exactly sure what data you're referring to there. Maybe we could take that offline.

Sean A. McCarthy: What I would say is that the SINO data that we have..., for the most part, discuss. There are two components to it. One is, we demonstrated.

Sean A. McCarthy: I think pretty convincingly that in a head-to-head comparison of antibody drug conjugate to pro-body drug conjugate, and if you take neutrophil counts as a surrogate of haematologic tox, that in the unmasked version, that is a very toxic molecule in sinos with neutrophil counts plummeting and animals not surviving for much more than a week, whereas with the pro-body, neutrophil And remember, as I mentioned earlier in the call, the principal toxicity from MMAE would be expected to be hematologic. So those experiments have been very important in showing that masking in preclinical studies has the potential to open a therapeutic window for the target. We did present an update on data at World ADC in London earlier this year, an update including some of the non-clinical studies looking at toxin in sino in a bit more detail, which again emphasized that the principal toxicities in sino are indeed hematologic. I'm not sure what data you're referring to regarding weight loss. We should maybe look at that offline.

[music].

Sean A. McCarthy: Okay, I mean, we can certainly touch on it later today when we talk. And I guess, you know, I have a last question. The separate program on the EGFR, you know, the IND filing at the end of 2021, can you just talk about whether you're pursuing T7 and 90 mutations with that program?

Sean A. McCarthy: I can't talk about that at this point.

Operator: Okay, all right, thank you.

Operator: Take care, Barron. Thank you.

Operator: Thank you, and I'm not showing any further questions at this time. I would now like to turn the call back to management for any closing remarks.

Sean A. McCarthy: Great. Thanks very much. Well, just to summarize again, it was a very strong quarter for the company despite the macro environments, and we look forward to catching up with all of you guys next quarter. Take care.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

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Q1 2020 Earnings Call

Demo

CytomX Therapeutics

Earnings

Q1 2020 Earnings Call

CTMX

Thursday, May 7th, 2020 at 9:00 PM

Transcript

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