CytomX Therapeutics, Inc. (CTMX) Q4 2019 Earnings Call Transcript – Motley Fool

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CytomX Therapeutics, Inc.(NASDAQ:CTMX)Q42019 Earnings CallFeb 27, 2020, 5:00 p.m. ET

Operator

Good day, ladies and gentlemen, and welcome to the CytomX Therapeutics' Fourth Quarter 2019 and Full Year Financials Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions]

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 -- Vice President, Investor Relations and Corporate Communications

Thank you, Lee. Good afternoon, and thank you for joining us. Earlier today, we issued a press release that includes a summary of our recent progress and fourth quarter 2019 and full year financial results. This press release and a recording of this call can be found under the Investors and News section of our website at cytomx.com.

With me today are CytomX's President, Chief Executive Officer and Chairman, Dr. Sean McCarthy; CytomX's Chief Development Officer, Dr. Amy Peterson; and CytomX's Vice President of Finance, Robin Knifsend.

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 public recent filings with the SEC at sec.gov, including our Form 10-K filed today. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments, or otherwise.

I would now like to turn the call over to Sean.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Great. Thank you very much, Chris, and good afternoon, everyone. Thanks very much for joining us. It's a pleasure to be here to provide an update on our progress during the fourth quarter and throughout 2019.

I'll begin with an overview and some recent highlights across the pipeline, and we'll then turn the call over to Amy to review our lead CX-072 and CX-2009 programs in more depth. Robin will then review our fourth quarter and full year financial update, and I'll wrap-up with upcoming 2020 milestones, before opening up the call for questions.

At CytomX, we see a major opportunity to more effectively target therapeutic antibodies into diseased tissue, generating new classes of anti-cancer therapies. We believe our unique Probody therapeutic platform represents a fundamental advance, and we are highly focused on the discovery and development of 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 potentially best-in-class molecules against validated targets, first-in-class molecules against novel undruggable 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. This allows us to localize antibody activity into cancer tissue, decreasing target engagement in normal tissues and broadening or in fact, even creating a therapeutic window. We have pioneered this new approach that we see as an important evolution of the therapeutic antibody field, with broad potential to improve and optimize a range of antibody formats, including cancer immunotherapies, antibody drug conjugates, and T-cell engaging by specific antibodies.

This is an exciting time for our Company, as our pipeline continues to mature, as our partnerships advance and as our research engine continues to produce innovative new molecules. In total, today, we have more than 20 programs at various stages of discovery and development within our proprietary pipeline and in collaboration with our partners. Since our first presentation of clinical data for our platform less than two years ago, we have now generated and presented a wealth of data to support clinical proof-of-concept for our technology, and our three most advanced programs have all recently progressed into focused Phase 2 clinical studies. We expect to provide several significant data updates throughout 2020.

Earlier this week, we announced an important pipeline milestone in our foundational oncology collaboration with Bristol-Myers Squibb. The leading edge of this alliance is the anti-CTLA-4 Probody BMS-986249. CTLA-4, the target of ipilimumab, is the prototypical checkpoint target, and blocking this mechanism has proven highly effective, both as monotherapy and in combination with PD pathway inhibitors in the broad treatments of patients with melanoma and in many other cancer types.

While a very important advance, ipilimumab can cause severe immune-related toxicities, creating a clear opportunity for a Probody version of this agent to improve tolerability, increase duration of treatment and potentially improve activity. BMS and CytomX have previously presented preclinical proof-of-concept for CTLA-4 Probodies at several major research conferences, and BMS has completed enrollment now in the Phase 1 clinical studies with BMS-986249, the results of which we expect to see presented this year.

As we announced on Monday, BMS has now initiated a randomized Phase 2 expansion study evaluating the tolerability and activity of BMS-986249 plus the PD-1 inhibitor nivolumab, versus nivolumab with or without ipilimumab in metastatic melanoma. The advancement of BMS-986249 into this study has triggered a milestone payment of $10 million to be -- to CytomX from BMS. 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 direct embodiment of exactly what we set out to do with our platform when it was first conceived of, and we are very excited about the potential for cancer patients.

Additional recent progress within our foundational BMS alliance includes the initiation of the dose escalation phase of Phase 1/2a clinical study for a second anti-CTLA-4 Probody, BMS-986288, which is based on a modified version of ipilimumab. This second clinical Probody program demonstrates BMS' commitment to our technology platform as a way to potentially unlock additional value in the CTLA-4 mechanism.

As these CTLA-4 programs progress through clinical development, potential regulatory approval and commercialization, CytomX is eligible to receive certain milestone payments and royalties, and it's important to note that we also continue to work closely with BMS to initiate new discovery programs under this broad-based alliance.

In addition to this progress with BMS, 2019 was a year of many achievements for CytomX within our wholly owned lead programs; the anti-PD-L1 Probody CX-072 and the anti-CD166 Probody drug conjugate CX-2009. We also advanced a very unique program in partnership with AbbVie, the CD71 targeting Probody drug conjugate CX-2029.

CX-072 is a Probody therapeutic directed against the validated immuno-oncology target PD-L1. We believe that CX-072 has the potential to become a differentiated foundation for combination anti-cancer therapies by increasing tolerability, achieving optimal dosing and delivering increased anti-cancer activity to improve patient outcomes. We have shown previously that CX-072 is active as a monotherapy in multiple tumor types and that the Probody has the activity to be expected from a checkpoint inhibitor, providing the first clinical proof-of-concept for our unique platform.

In the fourth quarter, we advanced CX-072 into a Phase 2 clinical trial to further evaluate the activity and tolerability of CX-072 plus ipilimumab in patients with relapsed or refractory melanoma. Building on our encouraging Phase 1/2 data, this trial is evaluating CX-072 in combination with the full label monotherapy dose and schedule of ipi with a goal of driving meaningful anti-cancer activity in this difficult-to-treat patient population. We believe this combination has the potential to become a best-in-class regimen not only for melanoma, but potentially other cancer types. Initial data is anticipated from Stage 1 of the Phase 2 study during 2020.

Now, turning to our second wholly owned drug candidate, CX-2009, a Probody drug conjugate designed to target the previously undruggable target, CD166. CD166 is a unique tumor antigen that is expressed at high levels on most solid tumors, but is also present on most normal tissues, ruling it out as a target for a typical antibody drug conjugate. We're exploring the ability of a Probody drug conjugate to unlock the potential of this target by focusing anti-cancer activity to tumor tissue and not normal cells.

Based on encouraging Phase 1 clinical data we reported last year, we initiated in Q4 2019 a Phase 2 expansion study of CX-2009 monotherapy in patients with hormone receptor positive, HER2 negative breast cancer. This study was initiated in the fourth quarter. Amy will provide more context on this program in a few moments.

Now, returning briefly to our collaborations and specifically within our AbbVie alliance, we continued to enroll patients in the dose-escalation and refinement phase of the proclaimed CX-2029 Phase 1/2 study, evaluating monotherapy CX-2029, a first-in-class Probody drug conjugate targeting CD71, and this is in patients with solid tumors. This is a very novel and ambitious program. CD71's biological role is to function as what we call a professional internalizer, as it moves iron from the extracellular space to intracellular compartments, and it does so in all dividing cells. CD71 is in fact the gold standard internalizer used to assess ADC activity in vitro. Now while an attractive target for payload delivery to cancer cells, it has remained undruggable, and in fact, we have shown that an ADC to CD71 is lethally toxic in preclinical models.

In partnership with AbbVie, we have created a Probody drug conjugate CX-2029 in which a masked antibody to CD71 is conjugated to the cytotoxic payload MMAE. Dose escalation in the clinic was initiated in mid-2018 and is ongoing as we progress toward the selection of a recommended Phase 2 dose. We anticipate the presentation of initial data from this exploratory clinical work in 2020. Should the study progress to cohort expansions at the recommended Phase 2 dose, we anticipate the presentation of proof-of-concept data in 2021.

For this program, CytomX has responsibility to advance it through initial proof-of-concept, whereupon if successful, the program will transition to AbbVie for registrational studies and ultimate commercialization. CytomX retains profit split and certain co-commercialization rights for this asset.

Before handing the call over to Amy for more detail on our lead programs, I'd like to spend a few moments on two earlier stage programs that are emerging as potential -- as a potential second wave of IND candidates in our pipeline. Starting with our collaboration with ImmunoGen, from whom in Q4 we obtained exclusive worldwide development and commercial rights to an EpCAM targeting Probody drug conjugate. This program was developed utilizing CytomX's Probody technology and ImmunoGen's drug conjugate technology and arose from our previous strategic collaboration between the parties.

At the 2018 European Antibody Congress and also at AACR 2019, ImmunoGen presented encouraging preclinical data demonstrating that an EpCAM Probody drug conjugate has potent activity in vivo efficacy models, as well as improved tolerability and exposure compared to an unmasked EpCAM antibody drug conjugate. CytomX now has full development control and commercial rights for this promising program.

Another promising preclinical program is our T-cell bispecific Probody targeting EGFR and CD3. This program is partnered with Amgen, with CytomX retaining development control and certain commercial rights. We're really excited about the prospects for the T-cell bispecific application of Probodies to enable solid tumor targeting of this modality. Solid tumor targeting with unmasked T-cell bispecifics has been very challenging for the field, due to narrow or non-existent therapeutic window. We anticipate advancing a lead clinical candidate for this program during 2020.

So, now let me turn the call over to Amy.

Amy C. Peterson -- Executive Vice President and Chief Development Officer

Thanks Sean. I'm pleased to be here today to report on the great progress we continued to make with our lead wholly owned programs CX-072 and CX-2009, including studies that set us up to answer important questions over the next one to two years.

Let's begin with our lead program CX-072. As previously reported, patient enrollment is complete for the Part D expansion cohort, starting in CX-072 at the dose of 10 milligrams per kilogram administered intravenously every two weeks to patients with multiple tumor types, and we expect to present a summary of our findings from these expansion cohorts this year. Data presented to date, most recently at ASCO 2019, showed that CX-072 functions as a checkpoint inhibitor, demonstrating encouraging activity where one would expect to see it with such agents, including triple negative breast cancer, anal squamous cell carcinoma, and cutaneous squamous cell carcinoma.

CX-072 tolerability appears favorable as well. And while numbers are too small to be clinically significant, trends toward lower rates of immune-mediated adverse events have been observed. Clinical pharmacokinetic and biopsy data has shown that the CX-072 Probody behaves as designed. That is it remains masked in the circulation and becomes unmasked in tumor tissue, resulting in intra-tumoral saturation of the target and anti-tumor activity. These findings provide an important clinical proof-of-concept for our platform and a strong rationale for differentiation of CX-072 from other PD inhibitors, and support combination strategies with other anti-cancer agents.

Given that combination therapy is likely to be required to make continued significant improvements in patient outcomes, we are focusing our efforts on CX-072 combinations, and in the immediate term, specifically, on the combination of CX-072 with ipilimumab. During our last quarterly update, I cited multiple clinical trials evaluating regimens involving a PD inhibitor plus a CTLA-4 inhibitor, where significant reductions in dose intensity of either agent, although more commonly with the CTLA-4 inhibitor, have been required in order to maintain a tolerable safety profile for patients. There are multiple studies demonstrating dose-dependent anti-cancer activity from ipilimumab. To-date, no one has been able to combine full doses of CTLA-4 inhibition with full doses of PD inhibition. We are interested to determine the extent to which our Probody platform can enable the combination of full dose PD inhibition here in the form of CX-072 plus full dose ipilimumab.

Accordingly in Q4 2019, we advanced into an open-label, non-randomized, multi-center Simon 2 Stage Phase 2 trial of CX-072 in combination with ipilimumab in patients with advanced melanoma, who have previously progressed on a PD pathway inhibitor. In this Phase 2 trial, patients are receiving ipilimumab at its full approved monotherapy labeled dose and schedule of 3 milligrams per kilogram every three weeks for four cycles, plus CX-072 at a fixed dose of 800 milligrams every three weeks for four cycles.

Upon completion of this combination, patients can receive continued treatment with 800 milligrams of CX-072 monotherapy administered intravenously every two weeks. The primary objective of this study is overall response rate with a secondary objective being safety, tolerability and other markers of clinical activity, including progress-free and overall survival, as well as the duration of response in those patients achieving partial and/or complete responses. Stage 1 of this trial aims to enroll up to 40 patients, and we hope to have initial data from this stage of the study in 2020.

To summarize, there are now two important studies under way evaluating Probodies in patients with melanoma. Each study is designed to show how these novel combinations can improve tolerability and lead to better outcomes for patients. There is a lot to learn from each study, most importantly the ability this platform offers to improve the risk benefit from IO-based therapy in people with cancer. And we're excited about these two studies and look forward to learning from each.

I'd like to now turn attention to CX-2009, our Probody drug conjugate targeting CD166, an ADC with a Probody mask. In the fourth quarter of 2019, we initiated an open-label non-randomized multi-center Phase 2 study of CX-2009 monotherapy in up to 40 patients with hormone receptor ER/PR positive and HER2 negative breast cancer. This subtype of breast cancer remains a substantial area of unmet medical need. And in this study, CX-2009 is being administered intravenously at 7 milligrams per kilogram every three weeks to this population. The initiation of this expansion study follows our presentation of encouraging dose escalation Phase 1 data at AACR 2019.

As you heard from Sean, CD166 is widely expressed, both on tumor and normal tissue, precluding the development of a CD166 targeting antibody drug conjugate due to expected systemic toxicities. We have leveraged our Probody technology to mitigate binding of CX-2009 to normal tissue, thereby creating a therapeutic window for this novel target. Our Phase 1 dose escalation trial was designed to gain a comprehensive look at the safety profile of this novel drug candidate, as well as assess exploratory markers supporting the hypothesis behind this platform. While not expected in a dose escalation study in a heavily pretreated and heterogeneous patient population, preliminary signs of single agent anti-cancer activity were observed and presented at AACR 2019.

As a reminder, the payload conjugated to CX-2009 is DM4, a maytansine derivative. Based on work conducted by ImmunoGen, from whom we licensed the payload, the toxicities associated with DM4 are well-documented and are predominantly ocular and/or neuropathic in nature. Payload toxicities typically define the MTD of drug conjugates and it's important to note that we would expect this to be the same for Probodies as for antibodies, since in the Probody it is the antibody that is masked, not the payload.

Probody drug conjugate strategy is to drug undruggable targets by achieving the maximum tolerated dose of the payload, but with -- but without the serious on-target off-tumor toxicities. Specifically with CD166, we are seeking to avoid on-target toxicities expected to occur in organs where CD166 is highly expressed, for example, in colon, pancreas and lung. And indeed, we were able to escalate up to 10 milligrams per kilogram, a dose that to our knowledge has never been previously had been -- has never been previously administered with any ADC.

And we did, as expected, observe payload toxicities, including keratitis and neuropathy. Taken together, these findings demonstrate clearly that our masking strategy was effective in protecting against on-tumor -- on-target off-tumor toxicities. And what was even more encouraging, as we reported at AACR in 2019, was that in patients who received more than or equal to 4 milligrams per kilogram of CX-2009, 38% achieved tumor shrinkage and 74% achieved stable disease or better at the time of the first on-treatment scan.

Observed anti-cancer activity included seven unconfirmed partial responses in breast cancer, including HER2 negative hormone receptor positive breast cancer, ovarian cancer and head and neck cancer. This risk benefit profile compares well to early Phase 1 experience for other ADCs that have advanced into registrational studies and supports the further development of this asset. We anticipate announcing more complete data from the CX-2009 Phase 1 dose escalation trial in 2020, and we anticipate initial data from the breast cancer Phase 2 expansion trial in 2021.

We're also very interested in the potential of CX-2009 plus CX-072 combination. We think -- when we think about the types of therapies that have been most successfully combined with PD inhibitors in terms of improvements and risk benefit profiles, we can't ignore the improved outcomes that have been observed in combination with cytotoxic agents. Furthermore, there's growing evidence that PD inhibition can be successfully combined with ADCs. We therefore also plan to evaluate the tolerability of the combination of CX-072 plus CX-2009 to identify a combination dose and regimen to advance in indications where both agents have demonstrated single-agent activity.

Turning to our organization, we continue to strengthen the development capabilities of the Company, and most recently announced the appointment of Dr. Alison Hannah to the role of Senior Vice President and Chief Medical Officer, reporting directly into me. Alison joins my team with 30 years of relevant experience in clinical drug development in oncology and malignant hematology.

Prior to joining us, she led her own consultancy, where she advised pharmaceutical and biotechnology clinical teams, resulting in successful filing of over 40 regulatory applications for first-in-human clinical testing, while also playing significant roles in the broad marketing approvals of eight therapeutics, including extensive experience interacting with global health and regulatory authorities. I've been fortunate to have worked with Alison during my time at BeiGene and Medivation, and look forward to her many contributions during this important time in the advancement of our pipeline at CytomX.

I will now turn the call over to Robin for a review of financials.

Robin Knifsend -- Vice President of Finance and Principal Accounting Officer

Thank you, Amy. I would like to review selected financial highlights for the year 2019.

We ended the year with cash, cash equivalents and investments totaling $296.1 million, compared to $436.1 million as of December 31st, 2018. Our strong balance sheet allows us to comfortably fund operations into the second half of 2021, assuming no new collaborations and/or financings. Research and development expenses were $132 million for the year, compared to $104 million in the corresponding period in 2018. The increase was primarily attributable to additional costs related to our maturing pipeline, including personnel related expenses.

In 2019, we incurred approximately $16 million of non-recurring charges related to the acquisition of technological knowhow, license fees to UCSB associated with entering into the amendment with UCSB and the license fee for the EpCAM program. General and administrative expenses were $37 million compared to $34 million in the corresponding period in 2018.

Revenue for the year was $57.5 million, compared to $59.5 million in the corresponding year. The decrease was primarily due to a $13.1 million decrease in revenue from AbbVie under the CD71 co-development and licensing agreement relating to the $21 million milestone payment net of the associated sublicense fees earned in May 2018 of which $11.7 million was recognized in 2018.

In addition, there is a slight decrease in revenue under our agreement with Amgen and decreases relating the Pfizer and ImmunoGen collaborations, which concluded in 2018. The decreases were partially offset by an increase in revenue from Bristol-Myers Squibb due to the accelerated revenue recognition related to the cessation of research on certain targets under our agreement with Bristol-Myers Squibb in the first quarter of 2019.

With that, I will turn the call back over to Sean.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Great. Thanks Robin. So, in closing, let me briefly review our anticipated 2020 milestones. For CX-072, our PD-L1 Probody, we anticipate presentation of final monotherapy data for the expansion arms in multiple selected tumor types, building on our ASCO 2019 presentations of last year. We also -- for the CX-072 ipi combination in relapsed or refractory melanoma, we anticipate initial data from Stage 1 of the ongoing Phase 2 study.

For CX-2009, our CD166 targeting Probody drug conjugate, we anticipate presentation of updated Phase 1 dose escalation and dose ranging data to support the dose and indication selection for the ongoing Phase 2 study you heard about today. And then for CX-2029, our CD71 Probody drug conjugate, we anticipate initial data from the Phase 1 dose escalation portion of the Phase 1/2 study with additional proof-of-concept data from expansion cohorts targeted for 2021, assuming that the program transitions to that stage.

Also and as I mentioned earlier on in my remarks, we do anticipate that BMS will present the Phase 1 data for the ipi Probody BMS-986249 sometime this year,, and that, of course, will be the data that has supported the announcement that we made this week regarding their entry into the randomized Phase 2 study of the ipi Probody that we're all very, very excited about.

So, thanks, everyone, for taking some time to join us today. It's obviously been a turbulent day out there in the markets. But we're very pleased with the broad progress we've made at CytomX last year and continuing into this year, both with our very unique technology platform and also with our advancing and deepening clinical pipeline. And all of us on the CytomX team are excited for an eventful 2020 ahead.

So, I think with that, we'll turn the call back to Chris for Q&A.

Christopher Keenan -- Vice President, Investor Relations and Corporate Communications

Lee, I think we're ready to open the call for questions.

Operator

Certainly. [Operator Instructions] Your first question is from Christopher Marai from Nomura Instinet. Your line is now open.

Christopher Marai -- Nomura Instinet -- Analyst

Hi, thanks for taking the question, and congrats on all the progress. I was wondering if you could touch upon -- on the CD166 2009 Probody program? I guess you updated us on the path forward there, including HER2 negative HR positive breast cancer. And that will constitute your expansion cohort in the Phase 2. Could you maybe elaborate a little bit on the potential path to approval that could emerge from that and how that might look? Is there a go-no-go decision that you're looking for? And then how might this fit into the evolving treating paradigm here? Obviously, other therapies are looking for approval in this setting as well. Thank you.

Amy C. Peterson -- Executive Vice President and Chief Development Officer

Sure. Hi, thanks, Christopher. This is Amy. Thanks for your question. Yes, so this study just to recap, the first part of the study we'll evaluate 40 patients with hormone receptor positive HER2 negative breast cancer. While we can't disclose the details around the eligibility criteria, what I can say is we have taken a sharp eye to that to ensure that the patient population is one that would be something that we could take forward to global health authorities, should we see activity commensurate with taking the molecule forward. And it is in patients, who have received hormonal-based therapy. We recognize that other treatments are emerging, and we always have an eye to that. But at this point in time, I can't really divulge further details around specifics of the eligibility criteria.

Christopher Marai -- Nomura Instinet -- Analyst

Okay. Then and just to follow-up perhaps a bit, expansion component of the trial I assume would not be registration-directed. At what point does CytomX make a go-no-go decision on this and run out a Phase 3 and even the population that you may be selecting in this expansion cohort? Thank you.

Amy C. Peterson -- Executive Vice President and Chief Development Officer

Sure. Thanks for the follow-on. So, you're right. With 40 patients, that's not registrational. However, depending on what we see and depending on our discussions with health authorities, it could potentially lead to something that is registrational if we have the right sample size. If that answers the question?

Christopher Marai -- Nomura Instinet -- Analyst

Yeah. And then just the go-no-go on data here, what do you want to see in those 40 patients? And then I'll jump back in the queue. Thank you.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

I think, Chris, as I mentioned, our goal there is to have initial data on this first 40 patients in 2021, and obviously, we'll take a look at that data and decide the path forward.

Christopher Keenan -- Vice President, Investor Relations and Corporate Communications

Next question, Lee.

Operator

Your next question is from Mohit Bansal from Citi. You line is now open.

James -- Citi -- Analyst

Hi, this is James on for Mohit. It looks like Bristol now has 986288 and 986249 in trials. Can you remind us how these two CTLA-4s differ, and any insight on BMS' strategy to explore both?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Yeah. Hi, James. Absolutely. So 249 is the Probody version of ipi itself. And I think as we've laid out, that's the program, that's being advanced into the randomized Phase 2 study. And that was the first Probody targeting CTLA-4 that we made with BMS in this alliance. 288 is, as we've said, a modified version of ipi that is designed to be more active than the parental antibody. I'm expecting them to probably say a bit more about this program this year, as the new leadership within BMS get their arms around these programs. So we're not at liberty to say too much about it. But we've made a Probody version of that modified ipi, and that has now also gone into Phase 1 dose escalation.

So, as I said in my prepared remarks, the fact that they're putting both of the -- one program now in Phase 2 and the other is moving into Phase 1. I think it really underscores a couple of things. It underscores their continued commitment to CTLA-4 as a target, and it very much underscores their interest and commitment to our technology.

James -- Citi -- Analyst

Thank you. I've just got a follow-on. In the press release you mentioned that the EGFR T-cell bispecific with Amgen is going to be advancing in 2020. Can you highlight what sort of developments have been made, and then if we'll be seeing any preclinical data this year?

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

We presented some preclinical data previously, as you may have seen in poster form. So the basic concept and the basic proof-of-concept behind EGFR CD3 has been presented. What we've been doing with Amgen for the last couple years is really working through the detailed protein engineering and molecular biology in order to how to optimize that format. And as I'm sure, there's a lot to that and there's a lot of different formats to sort through, a lot of geometry to get right in terms of the activity of the two arms of this type of bispecific. And all I can say is that we've made good progress, and we do expect to move toward lead clinical candidate stage over the course of this year with Amgen.

One other note is, as I mentioned, we do at CytomX, much like in the AbbVie alliance, we retain development control for this program through proof-of-concept. So we'll be filing the IND once we get to the point at having a clinical candidate that we agree to move forward with our partner.

James -- Citi -- Analyst

Fantastic. Thank you for taking the questions.

Sean A. McCarthy -- President, Chief Executive Officer and Chairman

Thank you.

Operator

Your next question is from Terence Flynn from Goldman Sachs. Your line is now open.

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CytomX Therapeutics, Inc. (CTMX) Q4 2019 Earnings Call Transcript - Motley Fool

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