Q3 2021 CytomX Therapeutics Inc Earnings Call

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Operator: Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to Sotomix Therapeutics' Third Quarter 2021 financial results call. Please be advised that today's call is being recorded. I'll now hand the call over to your host for today, Chow Ching, Saitomics's vice president of investor relations and corporate communications. Sir, please go ahead.

Good afternoon, ladies and gentlemen, thank you for standing by and welcome to SaaS told mixes Therapeutics third quarter 2021 financial results call.

Chow Ching: Thank you, Jesse. Good afternoon, and thank you for joining us. To me today are Dr. Sean McCarthy, Scytomics President, Chief Executive Officer, and Chairman; and Carlos Kempoy, Chief Financial Officer. Earlier today, we issued a press release that includes a summary of our third quarter 2021 financial results and highlights the important progress we made during the quarter. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC.

Chow Ching: Additionally, the press release and a recording of this call can be found under the investors and news section of our website at sitomics.com. 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 risk, including the uncertainty surrounding the COVID-19 pandemic, which 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 SCC.gov, including our Form 10Q filed today. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future developments, or otherwise. With that, I'd like to turn the call now over to Sean.

Sean A. McCarthy: Thank you, Chow, and good afternoon, everyone. Thanks for joining us today for an update on recent progress and developments with our clinical and preclinical programs and our company operations. At Cytomics, we are dedicated to destroying cancer differently. Leveraging our pro-body technology platform, we have created a robust and differentiated pipeline of novel, potential first in class and best in class, conditionally activated biologics. Conditionally activated biologics offer much promise for the treatment of cancer, and Cytomics' ambition is to discover, develop, and commercialize more effective and safer therapy.

Conditionally activated biologics, but much promise for the treatment of cancer and cytogenetics ambition is to discover develop and commercialize more effective and safe therapies.

Sean A. McCarthy: The lead programs in our broad development pipeline are the conditionally activated antibody drug conjugates, CX2009, Pralusatomab, and Ravtanzin directed towards CD166 and CX2029 directed towards CD71, the transparent receptor. These two potentially first in class assets both target novel tumor antigens and are currently being evaluated in phase two studies. Polyazamab is under evaluation in a three-arm phase two study focused on her two non-applified breast cancer, with initial data readouts anticipated in 2022. Arm A of this study is focused on hormone receptor positive disease.

The lead programs in our broad development pipeline or the conditionally activated antibody drug conjugates CX Tusa reserve nine probably start some of our breath tenzing directed towards CD 166, and.

And CX <unk> two nine directed towards <unk> 71, the transferrin receptor.

These two potentially first in class assets, both target novel tumor antigens and are currently being evaluated in phase III studies.

<unk> is under evaluation in a three arm phase II study focused on her two non amplified breast cancer with initial data readouts anticipated in 2022.

Arm a of this study is focused on hormone receptor positive disease <unk>.

<unk> is focused on triple negative breast cancer.

UMC is focused on triple negative breast cancer in combination with our proprietary PDL one inhibitor pack millimeter.

All three arms of this study are open and enrolling and enrollments accelerated in Q3 with more than 30 sites actively recruiting patients, including additional study centers in Spain, and South Korea.

Moving now to CX <unk>, two night targeting CD 71, which is being studied in four expansion cohorts building on our previously reported phase one dose escalation study, where we observed promising clinical signals in squamous non small cell lung cancer, and squamous head and neck cancer.

Sean A. McCarthy: Arm B is focused on triple negative breast cancer, and arm C is focused on triple negative breast cancer in combination with our proprietary PDL1 inhibitor, Pacmillam. All three arms of this study are open and enrolling, and enrollment accelerated in Q3, with more than 30 sites actively recruiting patients, including additional study centers in Spain and South Korea. Moving now to CX2029, targeting CD-71, which is being studied in four expansion cohorts, building on our previously reported phase one dose escalation study, where we observed promising clinical signals in squamous non-small cell lung cancer and squamous head and neck cancer.

Our ongoing study is the expansion phase of the phase one two study evaluating CX two thirds uniting these two indications and also in the Softgel Gastroesophageal junction cancers, and diffuse large b cell lymphoma.

Each cohort aims to enroll up to 25 efficacy evaluable patients treated at the recommended phase II dose of three mix per kg every three weeks.

<unk> has partnered with Abbvie under a global co development agreement with <unk> executing the program through clinical proof of concept.

Patient enrollment for the expansion phase continued in the third quarter and we remain on track to announce initial data from the lung and head and neck cohorts of this study next month.

I want to take a few moments to highlight the potential opportunity for <unk> in these tumor types.

Lung cancer is the leading cause of cancer deaths worldwide with approximately $2 2 million new cases globally in 2020, and 225000 of those in the United States.

Non small cell lung cancer is the most common type of lung cancer and accounts for about 85% of all cases.

Squamous non small cell lung cancer, which represents about 30% of non small cell is a devastating difficult to treat form of the disease.

Five year survival rate for patients with metastatic disease is less than 5%.

Sean A. McCarthy: Our ongoing study is the expansion phase of a phase one two study, evaluating CX2029 in these two indications and also in esophageal, gastroasopogial junction cancers and diffused large B-cell lymphoma. Each cohort aims to enroll up to 25 patients who are valuable, treated at the recommended phase two dose of three mixes per gig every three weeks. TX2029 is partnered with AvV under a global co-development agreement, with Citomics executing the program through clinical proof of concept. Patient enrollment for the expansion phase continued in the third quarter, and we remain on track to announce initial data from the lung and head and neck cohorts of this study next month.

In this setting that we are evaluating the activity of <unk> as a novel therapeutic option.

Head and neck cancer was diagnosed in nearly 750000 individuals worldwide in 2020 of these around 66000 cases occurred in the U S where more than 14000 patients die from the disease that year.

The disease, usually begins in the squamous cells that line the mucosal surfaces of the head and neck, including the Paranasal sciences nasal cavity oral cavity filings and <unk>.

Two thirds of patients with head and neck cancer are diagnosed in the advanced stages of more than half of those treated eventually relapse.

Median survival for squamous head and neck cancer patients with metastatic relapse is under one year and new treatments are urgently needed.

As I mentioned earlier, we remain on track to announce our initial expansion phase data for CX <unk> two nine in these two areas of significant unmet medical need in December.

I would now like to move to earlier sites ethics programs and new applications of our versatile technology, starting with CX 904, our first conditionally activated T cell bi specific antibody.

Sean A. McCarthy: I want to take a few moments to highlight the potential opportunity for CX2029 in these tumor types. Lung cancer is the leading cause of cancer death worldwide, with approximately 2.2 million new cases globally in 2020, and 225,000 of those in the United States. Non-small lung cancer is the most common type of lung cancer, and it is about 85% of all cases.

Sean A. McCarthy: Claimus non-small lung cancer, which represents about 30% of non-small cell lung cancer, is a devastating, difficult to treat form of the disease. The five-year survival rate for patients with metastatic disease is less than 5%. And it's in this setting that we are evaluating the activity of CX2029 as a novel therapeutic option. Head and neck cancer was diagnosed in nearly 750,000 individuals worldwide in 2020. Of these, around 66,000 cases occurred in the US, where more than 14,000 patients died from the disease that year.

Okay.

To that end, we have engineered a conditionally activated interferon alpha <unk> for tumor selective biological activity.

Interferon Alpha was in fact, the first immunotherapy to be approved more than three decades ago, and we believe much potential remains to be realized by harnessing the potent immune modulating activity of this plan trophic cytokine.

As we've previously announced preclinical characterization at improved therapeutic index of the jewelry masked interferon Alpha <unk> will be presented next weekend, Sissy and Washington D C.

Sean A. McCarthy: The disease usually begins in the squamous cells that line the mucosal surfaces of the head and neck, including the paranasal sinuses, nasal cavity, oral cavity, pharynx, and larynx. Two-thirds of patients with head and neck cancer are diagnosed in the advanced stages, and more than half of those treated eventually relapse. Median survival for squamous head and neck cancer patients with metastatic relapse is under one year, and new treatments are urgently needed. As I mentioned earlier, we remain on track to announce our initial expansion phase data for CX2029 in these two areas of significant unmet medical need in December.

This work not only demonstrates the potential of the <unk> platform to improve the therapeutic window for this potent anti cancer therapy.

But also serves as a proof of concept for the application of our technology to cytokines broadly on opportunity that we had to pursue aggressively.

I'll now hand, the call over to Carlos.

Thank you Sean.

<unk> remains in a strong financial position to support our clinical and research agenda that Sean just reviewed which is to maximize the benefit of our conditionally activated therapeutic candidates for people with cancer.

As of September 32021, we had $336 million in cash cash equivalents and investments, which we project will fund the operations of the company well into 2023.

Sean A. McCarthy: I would now like to move to earlier CITermics programs and new applications of our versatile technology, starting with CX904, our first conditionally activated T-cell bi-specific antibody. CX904 targets the epidermal growth factor receptor, or EGFR, on tumor cells and CD3 on T cells, and is partnered with Amgen. EGFR is a highly validated and broadly expressed tumor target that confers many opportunities in oncology. Multiple anti-EGFR therapeutics are currently in use, including targeted small molecules and the anti-EGFR monoclonal antibodies, cetucsabat, and panatumab.

So we continue to innovate by advancing our novel therapy advancing novel therapeutic programs towards the clinic, including CX 904, and our emerging work in the field of conditional cytokines.

Sean A. McCarthy: Anti-GFR antibodies are approved in only a limited set of cancer types, yet EGFR is expressed in five of the ten highest incidence cancers and remains a target of high interest for the development of new biologics. The challenge with leveraging EGFR as a target for T-cell engagers is that the broad distribution of the target on normal tissues precludes the use of conventional strategies due to widespread toxicities at low doses. We have previously presented preclinical data from Cytomics showing that our conditional activation technology has the potential to improve the therapeutic window of an EGFR CD3 T-cell engager, and we are on track to submit an IND for CX904, a duly masked by specific, to the FDA before the end of this year.

Our partner BMS continues to work towards data from a randomized phase II study comparing our <unk> pro body in combination with <unk> all of that so in <unk> frontline metastatic melanoma study.

I want to thank our clinical team who has intense focus has allowed us to make excellent progress towards phase III Readouts for a first in class lead clinical programs.

They are pushing the boundaries of ADC drug development by leveraging previously Undruggable targets.

As we continue to drive the translational science of the property platform and the tumor microenvironment, we're honored and privileged to have Dr. Alan Ashworth joined <unk> Board of directors.

As president of the UCSF, Helen Diller family comprehensive cancer Center, and former Chief Executive of the Institute of Cancer Research in the U K, Ireland is a world renowned expert in cancer research and an accomplished global leader in cancer therapy development.

We look forward to <unk> contributions as we advanced our clinical pipeline towards key phase II inflection points and as we continue to lead the field a conditionally activated therapeutics.

With that operator, please open the call up for Q&A.

Thank you speakers participants we will now begin the question and answer session to ask a question over the phone you May press to Starkey followed by the number one.

Sean A. McCarthy: Within our Angel Alliance, Zytomics is responsible for I&D filing and clinical execution for CX904 through initial clinical proof of concept. Another exciting and emerging area for the Cytomics platform is the application of our proprietary conditional activation technologies to the field of cytokines. To that end, we have engineered a conditionally activated interferon alpha 2B for tumor selective biological activity. Interferon Alpha was, in fact, the first immunotherapy to be approved more than three decades ago, and we believe much potential remains to be realized by harnessing the potent immune-modulating activity of this pleiotropic cytokone.

Sean A. McCarthy: As we previously announced, preclinical characterization and improved therapeutic index of duly mast interferon alpha-2b will be presented next weekend at Sissy in Washington, D.C. This work not only demonstrates the potential of the cytomics platform to improve the therapeutic window for this potent antic cancer therapy but also serves as a proof of concept for the application of our technology to cytokines broadly, an opportunity that we aim to pursue aggressive

Present meaningful progress towards that goal. It will include likely a mix of patients with one or more post baseline scans and of course follow up of patients with regard to the.

Management the incidents in management of of anemia, which is the the side effects that were obviously tracking most closely give them what we learned in phase one.

Alrighty. Thanks.

Next question is from Ah New from Rama of J P. Morgan your lines now open.

Thanks, So much for taking the question just two quick ones to me first 12009, you guys noted the site expansion is there any plants to further expand your sites and what type of enrollment sort of progress and trajectory much.

Carlos Kempoy: I now hand the call over to Carlos.

Carlos Kempoy: Citomics remains in a strong financial position to support our bold clinical and research agenda that Sean just reviewed, which is to maximize the benefit of our conditionally activated therapeutic candidates for people with cancer. As of September 30, 2021, we had $336 million in cash, cash equivalence, and investments, which we project will fund the operations of the company well into 2020. For the third quarter of 2021, revenue was $18 million, relatively flat when compared to the corresponding period in 2020.

You need to give us a little bit more.

Granular timelines for data then broadly 2022, that's the first question. The second one follow on to the first one which is I guess thinking about 2029, what what would get you excited a kind of a win scenario. Thanks so much.

Yeah. Thanks for the questions Uhm. So regarding 2009, yeah, we're very pleased with the progress in Q3 with activation an ongoing enrollment went off.

Ready to give additional specifics of enrollment numbers, but we are pleased with the progress that the team has made over the last few months, we will be adding additional sites in the coming months as well but.

Carlos Kempoy: R&D expenses increased $5 million to $29 million during the three months ended September 30th, 2021, compared to the third quarter of 2020. The increase was driven by personnel, clinical trial, and consulting and contract expenses, primarily related to Prolzatomab and CX2029. GNA expenses were $11 million during the three months ended September 30th, 2021, an increase of $2.5 million compared to the same period in 2020. The increase was attributable to personnel-related expenses as well as professional services.

But for now our guidance continues to be data in in 2022 will be working to refine that as we move into.

Into the new year.

Regarding 229 in the two.

Expansion cohorts.

<unk>.

Learning to present updates on next month in the head and neck and lung obviously, we're in the second and third line setting here and Cigna.

Significant unmet need you heard our our comments on the the nature of the unmet need in these patient populations and.

Carlos Kempoy: With that, I'll turn the call back.

Sean A. McCarthy: I want to close by emphasizing the leadership position that Pytomics has established in the field of conditionally activated biologics. Across multiple targets and within our broad and deep therapeutic pipeline, we have clearly demonstrated that conditional masking is a versatile approach to enhancing or indeed creating a therapeutic window for high-potential cancer treatments, and we see enormous potential in our technology. At Cytomics, we continue to innovate by advancing novel therapy programs towards the clinic, including CX904 and our emerging work in the field of conditional cytokine therapy.

Agents in the future.

Nothing really that we see in the anemia.

Sean A. McCarthy: Our partner BMS continues to work towards data from a randomized phase two study, comparing our epilumab probody, in combination with an involumab, to an ipinevo frontline metastatic malanoma study. I want to thank our clinical team, whose intense focus has allowed us to make excellent progress towards phase two readouts for our first in-class lead clinical programs that really are pushing the boundaries of ADC drug development As we continue to drive the translational science of the pro-body platform and the tumor microenvironment, we're honored and privileged to have Dr. Alan Ashworth join the Citonix Board of Directors.

Side effects.

Would preclude the types of combinations that one might think of pursuing so.

Don't see that as a particular barrier.

I don't want to comment on specific combination as I'm sure you can think about what they what they might be.

But we do know that Adc's R.

Combinable with a range of different mechanisms will be interested to explore those.

In in the future.

I wanted to just.

Also.

Restate.

Coming back to the question previously regarding.

Success looks like I wanted to just.

Restate, what we saw in phase one.

Dose escalation with these two.

Indications and starting with.

Sean A. McCarthy: As president of the UCSF Helen Dilla Family Comprehensive Cancer Center and former chief executive of the Institute of Cancer Research in the UK, Alan is a world-renowned expert in cancer research and an accomplished global leader in cancer therapy development. We look forward to Alan's contributions as we advance our clinical pipeline towards key phase two inflection points and as we continue to lead the field of conditionally activated therapeutics. With that operator, please open the call up for Q&A.

Operator: Thank you, speakers. Participants, we will now begin the question and answer session. To ask a question over the phone, you may press the star key followed by the number one. To withdraw your request, you may press the Pounder. Again, that's star 1 to ask a question or to pound on the key for a drier request. Our speakers are taking first questions from the line of Mara Goldstein of Muzov. Your lines are

Support for Mara Goldstein: Hi, this is Mara Goldstein's question on CX2029. First of all, you mentioned that there will be data in December. Have you identified the venues for that? And secondarily, to what extent do you think this data set would give clarity on how the toxicity of this compound can be managed?

Okay. That's great. Thank you that's all from me.

Again participants its star one to ask a question or the pound key to withdraw your request.

Next question is from Joe Catanzaro of Piper Sandler Your line is now open.

Hey, guys. Thanks, so much for taking my question, maybe just another one on CX 2029 here.

But asking more so about tolerability and the bar there.

How we should think about what's the.

Appropriate or reasonable rates of high grade anemia, transfusion burden growth factor support or should we be thinking more.

Sean A. McCarthy: Thank you. Yeah, hi, thanks for the question.

Sean A. McCarthy: Yeah, hi, thanks for the question. So first of all, or questions, I should say, first of all, with regard to venue, yes, so we're working towards announcing data next month. And that will be a press release and associated conference call. In terms of the, you know, what to expect, I'll comment on the safety side also, maybe a little more broadly.

Or R&D or meets the hurdles you just sort of said that in itself is indicative of a good tolerability profile.

Yes, Hi, Joe Great question.

Yes, So let me just talk a bit more broadly about.

In EMEA, how we're thinking about it based on the phase one work.

The first thing to say that.

We've said this many times before that with this drug candidate the anemia is.

As predictable reversible and we believe manageable with several.

Sean A. McCarthy: You know, this will be initial data; this will be a first look at a meaningful number of patients treated at the RP2D of three makes per kick Q3 week. The goal in each of the cohorts of the expansion phase is to enroll 25 patients for efficacy evaluation. patients, and we expect these first two cohorts to have to be able to present meaningful progress towards that goal. It will likely include a mix of patients with one or more post-baseline scans and, of course, follow-up of patients with regard to the management, the incidents, and management of anemia, which is the side effect that we're obviously tracking. Most closely, given what we learned in phase one. 30 Thanks. The next question is from Anupamrama of J.P. Morgan. Your lines are now open.

Anupam Rama: Thanks so much for taking the question. It was just too quick.

Thank you all for participating you may now disconnect and have a great day.

Anupam Rama: Just two quick ones from me. First, on 209, you guys noted the site expansion. Is there any plans to further expand your sites? And what type of enrollment sort of progress and trajectory might you need to give us a little bit more? granular timelines for data than broadly 2022. That's the first question. The second one, follow on to the first one, which is, I guess, thinking about 2029. What would get you excited about some kind of win scenario? Thanks so much.

Goodbye.

Sure.

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Okay.

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Sean A. McCarthy: Yeah, hi Adam, thanks for the questions. Regarding 2009, we're very pleased with the progress in Q3 with site activation and ongoing enrollment. We're not ready to give additional specifics on enrollment numbers, but we are pleased with the progress that the team has made over the last few months. We will be adding additional sites in the coming months as well.

Sean A. McCarthy: But for now, our guidance continues to be data in, in time. We'll be working to refine that as we move into the new year. Regarding 2029, in the two expansion cohorts that we're planning to present updates on next month in head and neck and lung, obviously, we're in the second, third line setting here, and there is significant unmet need. You heard our comments on the nature of the unmet need in these patient populations, and we think, broadly speaking, impact on these diseases with durations of response of, you know, four to six months would be terrific.

Sean A. McCarthy: Response rates in the 20 plus percent range would be great, given that these patients have a few options and also given that this is a novel drug candidate against a very unique target that intrinsically makes it a first-in-class therapeutic. So we'll see what we get. But that's broadly how we're thinking.

Anupam Rama: Thanks so much for taking your questions.

Roger Song: The next question is from Roger's Song of Jeffries. Your lines are now open.

Roger Song: Great, thank you for taking my question. The first question is also related to 2029. I think, Sean, you already mentioned the bar of what data you think it will be, you will think it will be a wing scenario, which is kind of a response to my thinking as well. And then maybe moving a step further is this is like a monotherapy setting, and if, given the toxic safety profile you have been seeing and the potential efficacy in this setting for those patients, what kind of a combination therapy you could potentially be considering

Sean A. McCarthy: Yeah, hi Roger, thanks. Great question. So you're right to point out that, of course, right now, we're laser focused on characterizing the monotherapy activity of 2029. And it's not lost on us, of course, that this is an agent that could very well be combined with a range of different agents in the future. There's really nothing that we see in the anemia side effect that would preclude the types of combinations that one might think of pursuing.

Sean A. McCarthy: We don't see that as a particular barrier. I don't want to comment on specific combinations. I'm sure you can think about what they might be. But we do know that ADCs are combined with a range of different mechanisms and will be interested in exploring those in the future.

Sean A. McCarthy: I wanted to just also restate coming back to the question previously regarding, you know, what success looks like. I wanted to just restate what we saw in phase one, dose escalation with these two indications and starting with lung where with squamous lung in phase one dose escalation we had four patients enrolled one of those patients was treated at one mixed cake which we didn't think would be an efficacious dose based on all of the modeling that we had done in the three that received two mixed cake or above we saw two confirmed PRs and one stable disease so you know certainly promising and that's the basis that led to the expansion that we're running right now in these additional 25 patients.

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Sean A. McCarthy: In head and neck, we had eight patients enrolled in squamous cell head and neck cancer eight patients enrolled in phase one dose escalation treated at two mixed for kage or above. We saw six patients of the epic seven efficacy available; we saw six with stable disease and one with a very deep and extended PR that actually lasted for more than six months. And so that's the basis, of course, on which we now are running these expansions, and we'll see what we see when we review and present the data next month.

Roger Song: That's great. I really appreciate all the color.

Roger Song: Maybe another question is related to the 904. Yeah, we understand the EGFR is definitely some kind of higher menu there. Just curious, any kind of additional thoughts around the plan and the tumor types and the timing for the clinical initiation and the data, potential data.

Sean A. McCarthy: Not much more to say there at this point in time. We're pleased with the progress we're making towards IND filing. And on our last call, we did mention that we were working towards a pre-I&D interaction with FDA. We had that interaction during Q3. It was highly productive and helpful in helping us continue to shape the I&D filing and the phase one strategy. And, you know, we're obviously looking forward to getting that IND filed and getting going in the clinic in 2020.

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Roger Song: Okay, that's great. Thank you. That's all from me.

Operator: Again, participants, it's star 1 to ask a question or to pound key to withdraw your request. The next question is from Joe Kadenzaro of Piper Sandler. Here are the lines now open. Hey guys, thanks so much for taking my question. Maybe just another one on CX-2020 here.

Joseph Michael Catanzaro: But asking more so about tolerability in the bar there and how we should think about what's the appropriate or reasonable rates of high-grade anemia, transfusion, burden, and growth factor support. Or should we be thinking more, you know, if the OR and DOR meet the hurdles you just sort of set, then that in itself is indicative of a good tolerability profile. Thank you. Yeah, hi Joe, great question.

Sean A. McCarthy: Yeah, so let me just talk a bit more broadly about anemia and how we're thinking about it based on the phase one work. The first thing to say, and we have said this many times before, that with this drug candidate, the anemia is predictable, reversible, and we believe manageable with several interventions, including transfusions, dose delays, those reductions, and we continue to explore the opportunities for erythricite stimulating growth factors like Darboatin, given that this appears to be an effect on early hematopoiesis.

Yeah.

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Sean A. McCarthy: It's important to note that, no, there were no events of anemia that led to discontinuation of CX2029 in the phase one study. And, you know, that's important. So, you know, we're obviously going to learn a lot more from the expansions, but that's the big picture on anemia. You're right to point out, though, that I would agree with you that it is an important consideration to consider anemia in the context of the overall profile of the drug as we gain more insight into its single agent activity.

Joseph Michael Catanzaro: Okay, great. Thanks for taking my question. My pleasure. Thank you, participants. At this time, I'll now hand the call back over to Chao Ching for his closing remarks.

Chow Ching: 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 on our future progress. Ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect. Have a great day.

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

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