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CytomX Therapeutics, Inc. (CTMX)

Q2 2022 Earnings Call· Fri, Aug 5, 2022

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Transcript

Operator

Operator

Good afternoon, everyone. Thank you for standing by. Welcome to the CytomX Therapeutics Second Quarter 2022 Financial Results Call. Please be advised that today's call is being recorded. I would now like to hand the call over to your host for today Chau Cheng, CytomX's Vice President, Investor Relations and Corporate Communications. Please, go ahead.

Chau Cheng

Management

Thank you, Yola. Good afternoon and thank you for joining us. Before we begin, I'd like to remind everyone that during this 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. We undertake no obligation to update any forward-looking statements whether as a result of new information, future developments or otherwise. Earlier this afternoon we issued a press release that includes a summary of our second quarter 2022 financial results and highlights recent developments at the company. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC. Additionally, the press release and a recording of this call can be found under the Investors and News section of our website. With us on the call today are Dr. Sean McCarthy, CytomX's Chief Executive Officer and Chairman; and Carlos Campoy, Chief Financial Officer. With that, let me turn the call over to Sean.

Sean McCarthy

Management

Thank you, Chau, and good afternoon, everyone. Thanks for joining us for an update on recent progress at CytomX. The foundation of our work at CytomX is to destroy cancer differently. With our innovative Probody therapeutic platform, we have blazed the new trail in oncology R&D and is now generally accepted that the conditional activation of biologics, offers tremendous opportunity for the development of new cancer therapeutics. At CytomX, we firmly believe that our multimodality Probody platform has the potential to deliver differentiated medicines for the treatment of people with cancer. To ensure CytomX remains well-positioned for the future, as announced last month, we have made a series of recent changes with the organization to prioritize our R&D investments and capitalize on our extensive clinical experience to date with our platform technology. Our restructured pipeline holds much promise for people with cancer and continues to span preclinical stage to Phase 2. CX-2029 is in the later stages of Phase 2 expansions and enrollment into the solid tumor cohorts has been completed. Our collaborative work with Bristol Myers Squibb continues, including the randomized Phase 2 study of BMS-986249 and we're also well underway with Phase 1 dose escalation for CX-904, our EGFR CD3 T-cell engaging bispecific. In regards to our early-stage pipeline, our recent decision to deprioritize praluzatamab ravtansine now enables us to focus our resources and capital towards two exciting new wholly-owned programs CX-801 and CX-2051. And I'd like to spend a few moments focusing on these new opportunities. CX-801 is our conditionally activated interferon alpha-2b, the lead program within our broad efforts in the cytokine field. Interferon alpha-2b is an approved immunotherapeutic that has demonstrated clinical activity in multiple cancer types and we believe, provides an orthogonal and potentially superior approach to cytokines like IL-2, IL-12 and IL-15 in…

Carlos Campoy

Management

Thank you, Sean. As of June 30, 2022, we had $228 million in cash, cash equivalents and investments. Our recently announced restructuring efforts that Sean mentioned earlier, should allow us to extend our cash runway to 2025. This runway forecast does not include any potential upfront or milestone payments from existing or future partnerships. For the second quarter of 2022, revenue was $18 million compared to the $16 million for the corresponding period in 2021. The increase was largely related to the CD71 collaboration with AbbVie. R&D expenses increased $5 million to $31 million during the three months ended June 30, 2022 compared to Q2 2021. The increase was primarily due to higher personnel-related expenses and laboratory contract services in support of our preclinical and clinical pipeline. G&A expenses were $11.7 million during the second quarter of 2022, an increase of $2.4 million over Q2 2021. The increase was mainly in personnel and professional expenses. Let me now turn the call back to Sean.

Sean McCarthy

Management

Thanks Carlos. In closing, we believe our recent decision to restructure CytomX puts us in the strongest possible position to maintain our technological leadership in conditional activation of oncology therapeutics and to advance our robust pipeline with substantial potential for patients. We're proud of the significant progress we continue to make building on the consistent achievement of technical milestones, including six INDs filed across three therapeutic modalities, four programs that have advanced to Phase 2 studies and more than 500 cancer patients who have been treated with our product candidates to date. Our corporate partnerships remain strong and we will continue to emphasize new business development as an integral part of our corporate strategy. As we've said before, we care for every patient, we learn from every patient and we deeply thank everyone involved in our efforts to make the biggest difference we can. We are committed to destroying cancer differently for the benefit of people living with cancer, and we remain firmly focused on building CytomX for the long-term. Operator, let's now open the call up for questions.

Operator

Operator

Thank you. [Operator Instructions] Your first question comes from the line of Kaveri Pohlman from BTIG. Please ask your question.

Kaveri Pohlman

Analyst

Yeah, good afternoon. Thanks for the update and for taking my question. For CX-904, can you provide any insight into the study that's ongoing? Are you starting with therapeutically relevant doses and how many dose levels you plan to test?

Sean McCarthy

Management

Yes. Hi, Kaveri. Thanks for the question. So we're, obviously, very pleased with the progress on 904 now being in the clinic and in the early stages of dose escalation. We haven't disclosed any significant details of the Phase 1 strategy just yet. I can say though that we are starting at a pretty low starting dose. We do -- I think it's important to be thoughtful in dose escalation with a modality like this. And I think that's very consistent with for example the update -- the exciting update we heard yesterday from Regeneron regarding their co-stimulatory strategies as well in terms of one needs to take it stepwise and learn in a very progressive way.

Kaveri Pohlman

Analyst

Got it. And maybe a follow-up. Based on your preclinical safety studies, what toxicities and/or DLTs you expect to see? And in terms of CRS rate, is there something you can point to that you would clearly say beforehand is good data?

Sean McCarthy

Management

We haven't really guided on what good data is going to look like. Like I said I think we need to take this program stepwise. I would emphasize that this is a Phase 1 study with a molecule that we expect to be highly potent as a T-cell engager. And so we are laser-focused in Phase 1 on safety. The data that we've presented previously on this general therapeutic concept of EGFR and CD3 is actually with a different preclinical molecule. We haven't disclosed yet the data or the architecture if you like of 904. We will do so in the future. But if you look at that previously disclosed data on the therapeutic concept of EGFR and CD3, we're obviously very focused on cytokine induction. And you can see in that previously presented data very, very substantial shifts in improvements in safety with the marketing strategies that we have employed. But, of course, in the clinic we'll be focused on all of these parameters as we move carefully and thoughtfully through this initial dose escalation phase.

Kaveri Pohlman

Analyst

Got it. Thank you.

Operator

Operator

Your next question comes from the line of Etzer Darout from BMO Capital Markets. Your line is now open.

Etzer Darout

Analyst

Great. Thank you for the question. So just wanted to get an update from you on benchmarks for the CX-2029 data in squamous non-small cell lung cancer. And I guess what you would characterize as good data on this upcoming update in the fourth quarter? Thank you.

Sean McCarthy

Management

Yes. Hi, Etzer thanks for the question. So I think as we've discussed previously in the data release that we presented towards the end of last year, just to recap that data, we presented -- announced data on 16 efficacy-evaluable patients towards the goal ultimately of enrolling 25 in that particular cohort. And we've announced previously that we are now and reiterated today that we've fully enrolled that cohort. But at the time of those 16 efficacy-evaluable patients we saw a response rate of just under 19%. So we saw three confirmed partial responses. And we had guided previously going into that update last year that a response rate of the 20% range would be clinically significant and very meaningful. And so we're right in that ballpark with that initial result. One could argue actually that that benchmark could even be a little bit lower, maybe towards 15%. And why is that? Well, because the patients that were enrolled, all 16 patients who had prior checkpoint inhibitor experience. And this is an emerging, of course, patient population where the unmet need is very significant where one would expect responses to chemo for example to be in the low double-digits. So with the full cohort data the full 25 patients, we'll be very pleased if we maintain the response rate in the range of what we've already disclosed.

Etzer Darout

Analyst

Great. Thank you.

Sean McCarthy

Management

Thank you.

Operator

Operator

And our next question comes from the line of Mara Goldstein from Mizuho. Your line is open.

Supawat Thongthip

Analyst

This is Supawat for Mara. My first question is on the CX-2029. How do you plan to disclose the data in the fourth quarter? Is it going to be like similar to last year by the press release, or is it going to be at the conference venue have you decided on that?

Sean McCarthy

Management

No comments on that at this point. As you can hear we're maintaining our guidance of presenting or sharing data by the end of the year. We will be -- now that the -- as we've announced today now that the enrollment into the -- all three of the solid tumor cohorts specifically head and neck lung and esophageal has been completed, we'll obviously be sitting down with our partner AbbVie later in the year to review data and start to think about next steps and disclosure strategy will be a part of that discussion as well. So there's no additional comment I can make at this stage.

Supawat Thongthip

Analyst

Got it. And then one more on that. So with regard to the esophageal and GEJ arms when do you expect they'd be mature enough to be disclosed publicly?

Sean McCarthy

Management

Yes. I can't comment on that yet other than to say that the cohort is fully enrolled and the data continues to mature.

Supawat Thongthip

Analyst

Got it. And then one more on BMS-962249. I was wondering if you can provide maybe additional color on the type of data that you plan to share or due in Bristol plan to share and perhaps a bit more color in terms of the tumors breakdown if you could?

Sean McCarthy

Management

Well, there's two things to say there, one which we mentioned in the call today that BMS did present the Phase I safety data at ASCO 2020. They will be presenting an update on the Phase I study, which obviously is now considerably more mature at ESMO coming up in a few weeks. With regard -- and as has been previously disclosed that patient population was a fairly typical Phase 1 study population for evaluating novel immunotherapy. So the usual mixed bag of tumor types. Of course, the Phase 2 study that they're running the randomized Phase 1 study of 249 is being conducted in frontline metastatic melanoma. That study continues to enroll and we will provide an update on timing of data as and when we have it.

Supawat Thongthip

Analyst

Got it. Thank you.

Operator

Operator

Your next question comes from the line of Mitchell Kapoor from H.C. Wainwright. Your line is open.

Mitchell Kapoor

Analyst

Hi. Thank you for taking the questions. I just wanted to know if you could remind us of the differentiation of the second EpCAM ADC versus the first generation? And what cancers might be a best fit for this program based on the design and the signature ratio?

Sean McCarthy

Management

Yes. Thanks Mitch for the question. So I think, you're referring to we've previously discussed and in fact we presented some data on a program we call CX-2043 an anti-EpCAM Probody drug conjugate or conditional ADC with the payload -- the maytansine payload DM21. Very important and impressive data set pre-clinically. We have moved on from that particular configuration to 2051, which we believe will have an even broader therapeutic window, and we're not yet ready to disclose the molecular architecture of 2051. We will have a presentation at the World ADC Conference coming up in San Diego in September. And we will be saying more about 2051 at that conference. In the context of the learnings that we have -- the many learnings we have from the 2009 and 2029 programs in the clinic.

Mitchell Kapoor

Analyst

Thank you. And for the squamous non-small cell lung cancer data, could you kind of walk us through what expectations you might expect to see if you were to look at patients by CD71 status? And to the degree that you could comment on those analyses that we might see at the data set that would be helpful.

Sean McCarthy

Management

Right. So, of course, as with any new target like CD71 we are highly interested in studying and understanding any relationship between target biology and anticancer activity. That work is ongoing. I can't say yet when we'll be ready to share that data. The study analysis is continuing, but that is something that is of course of high interest to us.

Mitchell Kapoor

Analyst

Thank you so much, Sean.

Sean McCarthy

Management

You’re welcome.

Operator

Operator

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

Unidentified Analyst

Analyst

Hey, good afternoon, guys. Thanks for taking the question. This is Alex on for Peter. Two questions for me. Just on CX-2029 and the update in lung cancer. Wondering if you could speak a little bit about safety and specifically anemia? And if you could talk about what would be acceptable in terms of the rate and grade of anemia to make this program move forward?

Sean McCarthy

Management

Yes. Hi, Alex, thanks for the question. So something that we continue to learn about continue to evaluate in regards to understanding mechanistically the anemia and also potential mitigation strategies, we've discussed this quite a bit in the past in our previously reported clinical work, the anemia has been managed through various means, including dose reductions, dose delays, erythrocyte stimulating agents. We did conclude earlier this year that probably the ESA route is unlikely to help as much as we might have liked. We continue to look at dose reductions, dose delays. And once we look at the full data set across all of the solid tumor cohorts, I think, we'll be in a better position to comment little bit later in the year.

Unidentified Analyst

Analyst

Okay. Great. Thank you. And then just a second question on business development. You've previously talked about remaining active in BD discussions. You obviously have a number of partnerships that -- where you partner your technology. I'm just wondering if you could speak to any interest in terms of looking at bringing in new technology externally. Or are you mostly focusing on partnering your technology to larger pharma players? Thank you.

Sean McCarthy

Management

Yes. So, great question and I think a couple of different components to that question. So, first of all, I would emphasize that the restructuring that we have announced recently just reemphasize that that puts us in a robust cash position into 2025. And that does not assume -- that guidance does not assume any additional business development cash inflows or any -- or indeed any milestones so many existing deals that we have. We do continue to be interested in leveraging the platform for additional business development in a strategic way. We continue to believe based on the progress we've made, and based on the discussions that we have over time that our technology is extremely relevant. I think if you look at the evolution of the ADC field, the evolution of the T-cell engager, and even co-stimulatory field that we heard about yesterday from Regeneron, and also the evolution of the cytokine field, we have a technology platform that we continue to believe can add significant value to these three areas. So there should be opportunities over the course of our cash runway, should we choose to take them to do additional deals that could generate non-dilutive capital. We'll see. I've always said we'll do the right deals at the right time. With regard to bringing in technology, we continue to follow the conditional activation space very carefully. I think we're in pretty good shape there in terms of the investments we've made internally. We have an industry-leading platform. And so I can't really comment on any other activities that we may have there at this stage.

Unidentified Analyst

Analyst

Great. Thank you.

Sean McCarthy

Management

You’re welcome.

Operator

Operator

At this time, I would like to hand the call back over to Chau Cheng for his closing remarks.

Chau Cheng

Management

So on behalf of the executive team, I'd like to thank you all very much for joining us this afternoon. We look forward to updating you in the future on our ongoing progress.

Operator

Operator

This does conclude today's conference call. Thank you for participating. You may now disconnect, and have a great day.