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CytomX Therapeutics, Inc. (CTMX)

Q2 2023 Earnings Call· Tue, Aug 8, 2023

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Transcript

Operator

Operator

Good day, and welcome to the CytomX Therapeutics Second Quarter 2023 Financial Results Conference Call. At this time all participants are in a listen-only mode. After the speaker’s presentation there will be a question and answer session. [Operator Instructions] Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Chris Ogden, Senior Vice President, Finance and Accounting. Please go ahead.

Chris Ogden

Analyst

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 second 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 second quarter. With that, I’m now turn the call over to Sean.

Sean McCarthy

Analyst

Thanks Chris, and good afternoon everyone. Thanks for joining us for an update on recent progress at CytomX. Before moving to a review of our pipeline, I would like to start by taking a moment to welcome our new Chief Medical Officer, Wayne Chu. We are thrilled to have Wayne on board as Chief Medical Officer, in which capacity he will oversee the clinical development of our diversified portfolio of pro body therapeutic candidates. Wayne’s extensive drug development experience over his career to date has contributed to multiple new drug approvals and spans therapeutic modalities, including antibody drug conjugates, checkpoint inhibitors, and bispecific immunotherapies, making him an ideal fit to lead the development of CytomX Pipeline. It is been a pleasure to get to know Wayne, and the team and I am excited to work with him closely as we optimize our clinical strategy and execute towards key milestones. Additionally, I would like to congratulate Dawn Benson on her promotion to Senior Vice President of Quality and Product Manufacturing announced today. Dawn joined CytomX in 2022 as head of quality and brings more than 25-years of quality and CMC experience in the biotech industry. Dawn has been a key contributor to CytomX strong recent execution, and we are delighted to have her moving into this newly expanded role. During Q2, CytomX maintained highly focused and disciplined execution across all areas of our company and pipeline. This is an exciting time for us. We are prosecuting more than 15 active programs across our wholly-owned and partnered pipeline. We are well financed. Our goals have never been clearer, and we are approaching multiple potential inflection points as we look ahead to 2024 and beyond. Before I cover this course’s progress, I would like to take a moment to provide some perspective on…

Chris Ogden

Analyst

Thank you, Sean. I’m pleased to be able to share an update on our second quarter 2023 financial results with you today. As of June 30, 2023, we had 181 million in cash, cash equivalents and investments, which does not include the $30 million received in July. As a result of the private placement financing with BBF, we expect our current cash resources to fund operations into the second half of 2025 in terms of our overall capital formation progress in the last year. The recent financing further builds upon our business development success and illustrates the company strategy and track record of funding the company through a balance of equity based and partnering strategies. Now let me spend a few minutes on cash for the quarter and our expectations moving forward. Cash burn was 23.6 million for the second quarter of 2023. This compares to a cash burn of approximately 34 million in the second quarter of 2022, where a year-on-year decrease in cash burn of approximately 30%. Looking to the company’s go forward cash needs, we expect overall cash burn to continue to moderate down over time for the full year of 2023 versus 2022given the company’s restructuring in July of last year. These cash expectations also include higher expected reimbursed R&D work from collaborations in 2023 versus 2022. Now, moving to revenue and operating expenses for the quarter. For the second quarter of 2023, revenue was 24.7 million compared to 12.9 million for the corresponding period in 2022. The increase was driven primarily by a higher percentage of completion for research programs in the Bristol Myers Squibb collaboration partially offset by reduction in revenue from the AbbVie collaboration as a result of the termination of the CD71 agreement in the first quarter of 2023. R&D expenses decreased 10.5 million to 20.7 million during the three months ended June 30th, 2023. The decrease was primarily due to decreases in personnel related expenses, laboratory contract services, and certain clinical study activities partially offset by an increase in laboratory contract services related to IND enabling activities. G&A expenses, or 7.4 million during the second quarter of 2023, a decrease of 4.3 million over Q2 2022. The decrease was primarily due to lower personnel related expenses as a result of the workforce reduction in 2022, and patent related legal expenses. With that, I will turn the call back to Sean.

Sean McCarthy

Analyst

Thanks, Chris. We appreciate everyone’s time in joining us for this update today. Now, well into the second half of 2023. CytomXis executing to plan and on track to deliver on key milestones as we advance towards 2024 and beyond. With the continued progress of CX-904 BMSs ongoing investment in the CTLA4 Probody program and our two upcoming R&D, we anticipate multiple inflection points over the next 12 to 18 months that have the potential to further solidify the importance and value of conditional activation and biologics localization in the treatment of cancer. Our exceptional highly dedicated team remains focused on our vision and mission, and as we have 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 in the treatment of cancer that we can. With that operator, please open up the call for Q&A.

Operator

Operator

[Operator Instructions] Our first question comes from Roger Song with Jefferies.

Roger Song

Analyst

So a couple from us, maybe start from the now four. So you guide the towards the Phase 1 data in first half next year. So what will be the expectations from there in terms of the patient number tumor type? And since you are going to get your dose expansion based on that data, what will be the key criteria you will look for to be able to say going forward towards the expansion cohort?

Sean McCarthy

Analyst

So let me just maybe just describe in a little more detail our objectives for the 904 program and how that how that looks over the 2023 2024 time period. So right now, as we have discussed we are in Phase 1A. We are in dose escalations safety assessment getting an early look at how the drug is functioning in patients principally from a safety standpoint. As I mentioned in my remarks we all know that T-cell engagers are of course, very potent agents and dose escalation early. Phase 1 assessment needs to be done thoughtfully and carefully in order to meet the primary objective, which is to get to safe doses for further exploration. And we are on track there. Our goal by the end of this year, as we have communicated, is to initiate backfill cohort. So to start expanding in a limited way, still in the context of Phase 1A in EGR positive tumor types to get a bit more experience of the drug in terms of obviously its safety likely more than one dose level. And also be looking in the context of those backfills, of course, for early signs of clinical activity now taken together, that data will inform in 2024 are discussions with our partner Amgen regarding the move from Phase 1 A to Phase 1 B, which would be a 2024 event. And that would be the, the Phase 1 B being of course the, the formal expansion phase of the study. So those are our goals. You, of course, it a continuum. So hard to say right now exactly what that data is going to look like in the first half of next year. But we would expect it to be a meaningful update and we will provide further guidance as the year goes on.

Roger Song

Analyst

So, maybe just another question related to the CD-71. You say you will provide update by the end of the year, and we just curious, what have you done and maybe any, um, learning you can share with us right now and by the end of this year? Will that be your decision or something you will share and then make decision later?

Sean McCarthy

Analyst

One of the new developments in that regard is of course our recruitment of Wayne. And he’s just joined the team a couple weeks ago, and as I mentioned, we are absolutely delighted to have Wayne on board. One of the many things that we are task him with is to do his own assessment of the CD-71 program. And his evaluation of course together with others will lead to the development of our strategy for the program on a go forward basis. So, we will have more to say about that over the next few months.

Operator

Operator

Our next question comes from Anupam Rama with JP Morgan.

Unidentified Analyst

Analyst · JP Morgan.

Hi guys, this is [Priyanka] (Ph) on for Anupam. We just had a quick question if most of the preclinical work needed for the CX-801 and CX-2051 INDs completed for the 4Q 2023 timeline?

Sean McCarthy

Analyst · JP Morgan.

Yes, so we are right on track with IND enabling activities including of course CNC and manufacturing. So all of the various components are moving along well, and we remain on schedule to get these INDs in by the end of the year.

Operator

Operator

Our next question comes from Peter Lawson with Barclays.

Unidentified Analyst

Analyst · Barclays.

This is [Alex] (Ph). Thank you for taking our questions. I wanted to come back to something earlier this year. You received a $5 million milestone from the Astellas collaboration, and they nominated a bispecific candidate. I was wondering if you could say anything about the target here, and also just remind us the economics from this collaboration, and if you could be -- when could you be eligible for additional milestones? Thank you.

Sean McCarthy

Analyst · Barclays.

Yes, thanks for the question. So yes, we were delighted to earn that milestone earlier this year following some really terrific work by the Astellas and CytomX teams. We are not at liberty to disclose the target identities from the collaboration, but we are really delighted to see that program now in IND enabling studies. We haven’t disclosed the structure as is typical of the milestone structure for the deal. But as the program makes its way through Phase 1, Phase 2 and beyond we would expect over the course of its natural history to receive additional payments for that, and other programs in that alliance and across -- of course our additional alliances as well. So I’m glad you brought it up though, because I think that milestone does reinforce a comment that I made in our prepared remarks, which is that if you look across the alliances that we have with so many partners, and as I mentioned, more than 15 active programs including partnered and wholly owned programs. I think that the milestone with Astellas, along with a significant amount of milestones that we have earned milestone flow that we have seen in past years. We do see significant potential for additional milestone payments over the next two to three years that is not currently factored into our cash runway guidance. And so, Astellas is just the latest example of the team’s productivity and our demonstrated track record in earning milestones under our collaborations.

Chris Ogden

Analyst · Barclays.

Hey Alex, this is Chris. The other thing I would note specific to Astellas, is we do have select commercial rights in the U.S. for a certain number of programs. So I think that is, again, glad you brought it up something that tends to not be a focus, but could create a lot of long-term value.

Operator

Operator

[Operator Instructions] Our next question comes from Depeche Patel with H.C. Wainwright.

Depeche Patel

Analyst · H.C. Wainwright.

Depeche Patel standing in for Mitchell Kapoor. When can we expect to hear more about the Phase 2 program of BMSS-986288? Can you provide any additional update on what the future development timeline and scope could look like for this program?

Sean McCarthy

Analyst · H.C. Wainwright.

So, no real update there in terms of timing at the moment, we are as we mentioned, excited about the continued investments that BMS is making in 288, the non coated CTLA four pro body. We think a very interesting and very competitive molecule in a growing field of next gen CTLA fours out there. We are in dialogue with BMS regarding potential future communication strategies but not much more we can say today.

Depeche Patel

Analyst · H.C. Wainwright.

And then can you kind of contextualize the reason for a pivot away from the fuco related version, which is the BMS-986249?

Sean McCarthy

Analyst · H.C. Wainwright.

Yes. So just to, that is right. So just to recap then, and thanks for the question. We have had two programs with BMS and CTLA four. One is the mass version of Ipilimumab itself the - AK, the few CAUS related version, the other being 288, which is the non few CAUS related. And I think if you look at how the field is on unfolding in CTLA-4, first of all, continued conviction from B MSS and other organizations, that there’s something pretty unique about CTLA-4 blockade in terms of its immunobiology that leads to deep and durable responses, particularly in combination with other checkpoint inhibitors and maintained interest in finding ways to get more value and impact for patients in multiple tumor types leveraging CTLA-4. The second point being to try to improve efficacy and the non CAUS related strategy appears to be able to do that. The mechanistic hypothesis, I think is still that it is the hypothesis, but the view is that the non causation enhances antigen presentation, which leads to more diversity in T-cell clones that leads to deeper and more durable responses. And that is taken together with the accessory co-stimulatory effects of CTLA four blockade leads to a unique mechanism of action compared to IPI alone. Now, one of the challenges that has come along with that more potent version of IPI is that it is expected to be more toxic and less tolerated, less well tolerated hence the value of the pro body platform. So yes, we are very interested to see how this all plays out with BMS. We are excited that they are focusing on 288. We think it makes sense based on the way the immunobiology is developing in the field, is unfolding and we anticipate their data when they are ready to share it.

Depeche Patel

Analyst · H.C. Wainwright.

Great. Thanks. I appreciate the additional color there. Just a couple more questions. I know we talked about CX-904, a little is this on track to complete by year end of 2023, and can you discuss any current thoughts on the back filling portion into the selected EGFR positive cohorts in ‘24?

Sean McCarthy

Analyst · H.C. Wainwright.

Yes. Just to reiterate my earlier comments and restate I guess the temporal aspects of the program. So the goal that we have stated for all of this year is to by the end of this year initiate back to cohorts. So we are exploring this drug at various dose levels. We will likely want to be in the future expanding project Optimus and just kind of best practice these days in exploring t-cell engagers and solid tumors. We will want to be exploring likely more than one dose as we move later into the program. And so, the selection of those doses is really a critical success factor for this asset. So we are being thoughtful about this. And right now, we are focused on dose escalation, assessing safety, beginning to select doses for initiation of backfills by the end of the year, and then transitioning once that backfill data is in hand, which will start to become available in the first half of next year, use that combined data set of the dose escalation and the initial backfills to then inform our Phase 1B formal expansion strategy. And as I mentioned in my comments, the move to Phase 1B expansions is a decision that we will take in collaboration with our partner Amgen sometime in 2024. So I hope that helps set the timeframe for the program.

Depeche Patel

Analyst · H.C. Wainwright.

Got it. Thanks so much. And then last question, can you provide an update on the Regeneron and Moderna collaborations, and when we can expect these programs to enter the clinic?

Chris Ogden

Analyst · H.C. Wainwright.

Yes, so continue to be super excited about these new partnerships and we are very busy with both Regeneron and Moderna, with Regeneron in ebispecific immunotherapies for cancer with Moderna for investigating mRNA encoded localized biologics in oncology and also outside of oncology. The programs are still relatively early, and it is really too early to comment on time lines at this stage. But thanks for the question. Really appreciate it.

Operator

Operator

That concludes the question-and-answer session. At this time, I would like to turn it back to Sean McCarthy for closing remarks.

Sean McCarthy

Analyst

Thanks everyone for your time this afternoon and your interest in CytomX and our progress. Certainly, hope this update in our broad pipeline has been helpful. Please feel to reach out to our Investor Relations team should you have any additional questions, and we look forward to keeping in close touch.

Operator

Operator

Thank you for your participation in today’s conference. This does conclude the program. You may now disconnect.