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CytomX Therapeutics, Inc. (CTMX)

Q1 2023 Earnings Call· Tue, May 9, 2023

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Transcript

Operator

Operator

Good afternoon, everyone. Thank you for standing by. Welcome to the CytomX Therapeutics First Quarter 2023 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 today, Chris Ogden, CytomX Senior Vice President, Finance and Accounting. Please go ahead.

Chris Ogden

Management

Thank you. Good afternoon, and thank you for joining us. Before we begin, I would 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 first quarter 2023 financial results and highlight recent progress at CytomX. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC. Additionally, the press release, a recording of this call and our SEC filings can be found under the Investors and News section of our website. With me on the call today is Dr. Sean McCarthy, CytomX' Chief Executive Officer and Chairman. Sean will provide a business and pipeline update before I walk through the financials for the first quarter. With that, I'll now turn the call over to Sean.

Sean McCarthy

Management

Thanks, Chris. Good afternoon, everyone. Thanks for joining us for an update on recent progress at CytomX. On today's call, I'll provide an update on the company's pipeline progress and the continued execution towards our key priorities for 2023 before opening up the call to Q&A. At CytomX, we believe that as biologic anticancer therapies become more and more potent, the need for localizing empowered modalities such as antibody drug conjugates, T cell engagers and cytokines into cancer tissue becomes increasingly important as a way to improve therapeutic window. Indeed, we believe that localization will be the future of biologics. CytomX vision is to transform lives with safer, more effective therapies. We aim to realize our vision for the benefit of patients by leveraging our Probody platform to create high-impact therapeutics that are localized to disease tissue, thereby reducing systemic toxicities and maximizing overall benefit. Our versatile platform for protease-based conditionally activated biologics has strategically positioned our company and pipeline at the intersection of some of the most promising areas of oncology research and development, and I'm excited to walk through the progress of the company during the first quarter of 2023. Throughout Q1, we continue to advance our diversified portfolio of innovative Probody therapeutic candidates for the treatment of cancer while ensuring disciplined resource allocation. CytomX entered 2023 with robust financial resources, positioning the company to execute towards multiple milestones over the next 12 to 24 months. We remain intensely focused on executing towards these milestones with CX-904 continuing to progress in Phase I and IND-enabling activities for CX-2051 and CX-801 remaining on track with IND filings projected for Q4 this year. With more than 15 internal and partnered programs, we are well positioned to deliver meaningful value to patients through the continued progression of our pipeline. Before moving…

Chris Ogden

Management

Thank you, Sean. I'm pleased to be able to share an update on our first quarter 2023 financial results with you today. Having completed our restructuring in 2022 and initiated the new research collaboration with Regeneron and Moderna, CytomX entered 2023 in a strong financial position with $204 million in cash, cash equivalents and investments as of March 31, 2023. Based on our current expectations and corporate objectives, we expect our cash resources will fund company operations to mid-2025. Our cash runway expectations do not include potential milestone payments from existing collaborations or any new business development. The cash balance of $204 million as of March 31 compared to $194 million as of year-end 2022. Cash received in the first quarter of 2023 included $35 million as a result of the upfront payment received from the Moderna collaboration and a $5 million clinical candidate milestone payment earned under the Astellas agreement. These collaboration payments are examples that underscore our continued ability to access nondilutive capital as well as earn ongoing cash flow through research funding and milestones. Now let me spend a few minutes on cash for the quarter and our expectations moving forward. Normalizing for the Moderna and Astellas cash inflows in the quarter, cash burn was approximately $30 million for the first quarter of 2023 compared to approximately $42 million in the first quarter of 2022. The reduction in cash burn versus the first quarter of 2022 was primarily driven by the corporate restructuring as well as pipeline prioritization. As we execute towards our 2023 and long-term objectives, we continue to maintain focus on prudently managing costs, including the execution during Q1 of a sublease for a portion of our facilities that will reduce rent expense starting in the second quarter of 2023. Looking to the company's go-forward operational cash needs, we expect overall cash burn to continue to moderate down from 2022 and the first quarter of 2023 as we move through the balance of this year. Now moving to revenue and operating expenses for the quarter. For the first quarter, revenue was $23.5 million compared to $9 million in 2022. The increase in revenue was driven primarily by higher percentage of completion for projects under the company's collaboration with Bristol-Myers Squibb, the milestone earned under the agreement with Astellas and the completion of the company's obligations under the CD71 collaboration agreement with AbbVie. R&D expenses decreased by $9.4 million to $21.2 million in the first quarter of 2023 compared to $30.6 million for the corresponding period of 2022, primarily due to a decrease in personnel-related expenses as well as winding down activities related to the CX-2009 and CX-2029 programs. G&A expenses decreased by $2.6 million in the first quarter of 2023 to $8 million compared to $10.5 million for the corresponding period in 2022, primarily due to a decrease in personnel-related expenses from the workforce reduction in 2022 as well as patent-related legal expenses. With that, I'll turn the call back to Sean.

Sean McCarthy

Management

Thanks, Chris. In closing, I would like to again emphasize the terrific execution by the CytomX team so far this year. Our scientific depth in biologics localization through conditional activation positions the company at the forefront of potential breakthroughs with potent biologic modalities such as ADCs, T cell engagers and cytokines. True innovation takes time. CytomX's current pipeline and financial strength has resulted from the continued execution of our long-term strategy in which we invest in big ideas and continuously learn from the translational cycle of bench to bedside to bench in order to deliver meaningful benefit for patients. We are intensely focused on driving towards key inflection points in our pipeline with particular focus on our U.S. programs. We remain well on track with the CX-904 Phase I study and our IND-enabling studies for CX-2051 and CX-801. Additionally, our scientific leadership has continued to attract valued new partners, allowing us to broaden our pipeline and maintain balance sheet strength. We look forward to continuing our work and providing future updates. With that, operator, please open up the call for Q&A.

Operator

Operator

[Operator Instructions]. Our first question comes from Mitchell Kapoor with H.C. Wainwright.

Mitchell Kapoor

Analyst

Just wanted to ask on CX-809. Once the IND is filed, what can we kind of expect for trial design and strategy? Would we be able to see you look towards tumor types on the label of approved interferon alpha-2b or is it too soon to say?

Sean McCarthy

Management

Yes, thanks for the question. It's a little too soon to say. I mean, as you rightly allude to interpret Alpha 2B has shown clinical activity in a variety of settings, including renal, melanoma, certain leukemias, hairycell, leukemia, follicular lymphoma. And more recently, in fact, quite recently, the approval of the gene therapy targeting interferon alpha 2 being non-muscle invasive bladder cancer in the VPG nonresponsive setting, where local administration clearly is highly active in that indication. So there are a number of places where we know interferon alpha is active, and we're currently evaluating the optimal strategy. One of the things that we're giving a lot of thought to is, of course, the long-term objective with this program given the potency of interferon alpha is to move into the area of cold tumors, I/O unresponsive tumors, but at a stepping stone, we'll likely be starting our work in tumor types where there's known to be more immune responsiveness, at least initially, teeing up potential combination strategies. So it will be a stepwise approach, and we'll have more to say as we get closer to filing the IND and initiating the clinical study.

Mitchell Kapoor

Analyst

Okay. Great. And then on 904, could you help us characterize what encouraging activity could look like? What would the threshold of activity need to be to trigger an expansion into a particular cohort?

Sean McCarthy

Management

Yes. Great question. And we are continuing with Phase 1. And I think we need to keep in mind, it's a Phase I study that we're running and the goal of Phase I with T-cell engagers is first and foremost, about evaluating safety and really trying to figure out doses to further explore further down the road in the expansion stage. So our goal for the program, as we've stated previously, is to continue to make progress with dose escalation this year to initiate enrollment into backfill cohorts by the end of the year in certain EGFR positive tumor types. And then as we move into 2024, we'll sit with our partner, Amgen, and talk about potential expansion strategies. Now of course, moving into formal expansions next year with this program in collaboration with our partner, Amgen. I think it's fair to say we're obviously going to want to see an attractive tolerability profile and also some evidence of tumor shrinkage, of course, as a monotherapy. But this is a Phase I study. And our expectations are principally to show the weighted doses to look at in later-stage studies in the expansion phase.

Operator

Operator

Thank you. And we'll move to our next question -- our next question comes from Roger Song with Jefferies.

Roger Song

Analyst · Jefferies.

Great. Maybe just 2 quick ones from us. The first one is now for understanding you will provide some updates later this year. Just curious what are the nature of the updates you will provide? And understanding you will start to backfill in the EGFR tumor type. But in terms of that data portion, what should we be expecting for the later this year update in terms of dose level or maybe a follow-up. And the second question is related to the CD71 given you have analyzed the data for some time, what are the current thinking around the next-generation strategy or what you're going to do to the current program in 2029?

Sean McCarthy

Management

Yes. Roger, thanks for the questions. I'll take the second one first, if I may. Not a whole lot of new updates today on CD71. We're in discussions with AbbVie regarding getting the license back to 2029. Those discussions are progressing well. And we'll have more to say about our CD71 strategy a little later in the year. Regarding 904, as I've already mentioned, our goal for this year, the operational goal for the program is to initiate enrollment into backfills by the end of this year. So that's the objective that we have. We're not ready at this stage to guide towards timing of any data presentations. We want to make more progress, get these backfills underway, continuing close dialogue with our partner, and we'll be issuing further guidance as the year progresses.

Operator

Operator

One moment for our next question. Our next question comes from Mara Goldstein with Mizuho.

Unidentified Analyst

Analyst · Mizuho.

This is [indiscernible] for Mara. Congrats on the progress. On CX-2029, I know that it's still a work in progress. But I'm just curious, what can you -- if you can elaborate on the gating factors on the consideration to reacquire the license back from AbbVie versus developing a next generation or are both options on the table?

Sean McCarthy

Management

Yes, everything is still on the table. And as I said, I think that we'll have more to say about it once we've completed our internal evaluations and there are multiple potential ways forward, we think. So I think this is kind of a stay-tuned moment for the CD71 program.

Unidentified Analyst

Analyst · Mizuho.

Got it. And then for the next-generation CD71, if you maybe can elaborate on what features do you hope that you can incorporate to make it a better compound versus the previous GENCI29? A –Sean McCarthy: Yes, I think simply put, our next-generation strategies that we’ve been working on internally over the last couple of years would be aimed at further increasing the therapeutic window. We’re – it’s clear that we’ve shown that we have opened a window for CD71 with 2029. We are the first company to achieve therapeutically active levels of an ADC targeting CD71 with activity across several tumor types. We have reason to believe we can do better in terms of further opening the window. And again, we’ll have more to say about that in due course.

Operator

Operator

And we have a question from Anupam Rama from JP Morgan.

Malcolm Kuno

Analyst

This is actually Malcolm Kuno on for Anupam. So when should we expect to learn more about which indications are going to be prioritized for CX-251? And then kind of what characteristics will you be looking for in making that determination?

Sean McCarthy

Management

Yes. Thanks, Malcolm. So one of the things that we really love about EpCAM as a target for 2051 is the breadth of its expression across epithelial tumors. Now, if you look into the databases, there's a ton of information available regarding the expression of EpCAM in tumors. And of course, one that really jumps out is CRC. So we're very likely to include CRC as one of our lead indications once we get into the clinic. The payload has also been selected. The [indiscernible] payload, the TOP1 inhibitor has also been selected with this in mind. However, there are multiple other tumor types where EpCAM is highly expressed, including gastric, ovarian, endometrial, lung, prostate. It's a long list. And so there's a lot of ways we could potentially go. I think what we're thinking through is the right balance of focus in Phase 1 versus breadth. And we haven't made a firm decision on that yet, but very likely to include CRC, potentially other indications. And in the long run, there's a ton of potential for this drug candidate that we see.

Operator

Operator

Thank you. And I'm showing no other questions in the queue. I'd like to turn the call back to Sean McCarthy for closing remarks.

Sean McCarthy

Management

Great. Well, thanks, everyone, for your time this afternoon and for your interest in CytomX. I hope this update on our broad pipeline progress has been helpful. And please feel free to reach out to CytomX Investor Relations should you or your teams have additional questions. Thanks very much.

Operator

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.