Q4 2023 CytomX Therapeutics Inc Earnings Call

T cell engagements bring very high potency in this purchase he can lead to toxicities in normal tissues, where the tube ration of interest may also be present.

In fact this is very often the case on normal tissue target expression is widely acknowledged to be a limitation on the development of T cell engages with solid tumors.

Furthermore, another well acknowledged limitation for T cell engages as cytokine release syndrome, resulting from systemic binding to CD three on T cells.

At <unk>, we have a broad based program focused on masking T cell engages to decreased tumor antigen binding in normal tissues and CD three binding in the periphery, thereby improving therapeutic index.

We're working with partners Amgen, Astellas, Regeneron and Bristol Myers Squibb in this exciting space.

Our lead program CX nine O for the targets the tumor antigen Egfr CD three on T cells.

CX 904 is designed to address the principal challenges of developing an egfr CD three T cell engagement with the goal of delivering antitumor activity at tolerable systemic doses.

This program is partnered with Amgen and a global co development collaborations.

The market opportunity for <unk> liner for his broad there are hundreds of thousands of egfr positive patients with metastatic tumors across a wide range of cancer types that could potentially be addressed by this therapy.

<unk> is currently conducting an ongoing phase <unk> study in late stage unselected patients with advanced solid tumors generally known to have Egfr expression.

Our principal goal for this phase I study is to evaluate safety and towards <unk> doses and schedules for detailed evaluation and specific egfr positive cancer types in phase one b.

More specifically on safety, we're looking to keep Crs and the typical egfr mediated toxicities at manageable levels in order to achieve doses in the predicted therapeutically active range.

The selection of a phase one b tumor types will be driven by a combination of factors, including observations from phase Iia unmet.

Unmet medical need and commercial potential including fit with our partners strategic interests.

We're making steady progress in the clinic, having now advanced through multiple dose cohorts of the above those levels that would be expected to be tolerated with an unmatched egfr T cell engagement.

In late 2023, we also began to backfill certain dose levels to more fully explore the profile of this drug candidate.

We expect to share initial phase one dose escalation data in the second half of 2024 with our partner Amgen and also to present these data in an appropriate setting externally.

These data will inform a potential decision to initiate phase will be in 2025.

Moving now to our continued work in the antibody drug conjugate space.

This is tremendous progress in adcs in the past few years and the impact for patients has driven significant strategic interest in this field.

CX 2051 is our first in class <unk> directed <unk> ADC.

Our R&D application for CX 2051 was cleared by the FDA in January clinical study startup activities are in progress and we expect to initiate phase one dose escalation in solid tumors generally known to have <unk> expression, including colorectal cancer in the near term.

<unk> is a high potential oncology target due to its high cell surface expression in many cancer types. Indeed have cameras what are the first <unk> to be characterized more than three decades ago.

It has been implicated in many roles in cancer progression.

Anti <unk> therapeutic strategies have shown potent anticancer activity in preclinical models and this has been translated into clinical activity, but to date clinical success has been limited to local administration because <unk> is present in so many normal epithelial tissues.

Efforts to generate systemically administered <unk> therapeutics have not been successful to date due to toxicities of epithelial tissues, including the Gi tract.

Our innovative drug candidate <unk> 501 is tailored to optimize the therapeutic index for <unk> expressing epithelium cancers by marking the antibody to reduce binding in normal tissues, but to allow activation and tumor tissue.

We have arms the antibody with a cytotoxic payload based on Camptothecin. That's helped by Sunrise one inhibitor a class of drug that has shown potent clinical anti cancer activity in the ADC context, but multiple targets leading to dramatic advances for patients.

<unk> thousand 51 has demonstrated a wide predicted therapeutic index and strong preclinical activity and tolerability in multiple preclinical models, including colorectal cancer.

Like Egfr I discussed previously <unk> thousand 51 could also potentially address a large patient population is that Tam is highly expressed across many indications, including colorectal gastric endometrial and ovarian cancers.

Our phase one trial will follow an adaptive design and is intended to demonstrate rapid clinical proof of concept to inform a potential decision to move into dose expansion studies in 2025.

We're really excited to see what this unique and first in class ADC can do for patients.

Turning now to <unk> hundred one our Julie masked conditionally activated interferon Alpha <unk>, which we believe has the potential to become a cornerstone of combination immunotherapy for a wide range of tumor types.

The <unk> hundred one was cleared by the FDA in January and we expect to initiate phase one dose escalation in solid tumors.

Including melanoma, renal cancer, and head and neck squamous cell carcinoma in.

In the first half of 2024.

Interferon Alpha is a powerful cytokine with the ability to Potently drive tumor antigen presentation and activate antitumor immunity.

As demonstrated clinical activity and gained regulatory approval many years ago in multiple cancer types, including melanoma renal cancer and bladder cancer.

However, interferon therapy is well known to be associated with significant systemic side effects and its use has been superceded by checkpoint inhibitors and other therapeutic approaches.

It's also been shown that if Iran could potentiate the clinical effects of PD, one in metastatic melanoma, but again. This approach has been limited by systemic toxicities.

Interferon therapy has recently returned to focus with Ferring pharmaceuticals approval in 2022 of us delivering an interferon alpha <unk> encoding gene therapy indicated for the treatment of localized BCG nonresponsive non muscle invasive bladder cancer.

Reaffirming that this potent cytokine can indeed achieve robust anti tumor responses in patients.

Based on the preclinical profile of six 801 as well as prior clinical experience with interferon therapies, we see 801 as a potential new centerpiece of combination cancer immunotherapy.

Preclinical data most recently presented a 62023 demonstrates synergy for our masks interferon alpha with PD, one inhibition, both in terms of edge tumor activity and an activation of the tumor inflammatory microenvironment.

Moreover, we have also shown the systemic activity of our Mas interferon is significantly reduced and overall tolerability is markedly improved compared to the unmatched cytokines in animal models.

We anticipate.

The opportunity the opportunity for <unk> hundred one will be in combination with checkpoint inhibition, where it could serve as a potent immune modulator to both increase the frequency and durability of responses and Io sensitive tumors are potentially to establish or restore efficacy and io resistant or cultures.

Our phase one dose escalation trial being initiated in the first half of 'twenty 'twenty four will utilize an adaptive design to evaluate safety and signs of clinical activity for eight hour monotherapy and advanced rapidly in combination with checkpoint inhibition.

Speaker Change: Before moving to financials I would like to provide updates on our partnerships and starting with an update on our long standing collaboration with Bristol Myers Squibb.

Speaker Change: We were informed on March 6th of BMS intention to discontinue BMS $906 eight eight the <unk> program.

This unexpected decision followed a broad internal portfolio review at BMS.

Speaker Change: We continue to work with BMS to gain more visibility on the data from this program and the factors that led to this decision.

Speaker Change: Moving forward. The BMS collaboration continues to be very active and we will now focus primarily in the field of T cell engagements, where together we have initiated several new programs over the last two years.

Speaker Change: Notably this shift in focus within the BMS Alliance now means that the majority of our partnered programs are now focused on T cell engagements, reflecting strong strategic interest in this area and showing that this modality modality is emerging as a key application of masking and conditional activation.

Speaker Change: Continuing the T cell engage a theme given our ongoing progress with enrollments of the CX 904 phase one study I'd like to outline some of the key terms of our strategic alliance with Amgen.

Speaker Change: Under the terms of our agreement Cytogenetics and Amgen are co developing CX 904 sites.

Speaker Change: <unk> is responsible for early stage development and Amgen will be responsible for late stage development with the transition occurring after completion of phase one b <unk>.

Speaker Change: Within the CX 904 agreement side. So it makes us an option to participate financially in the global co development of CX 904, with Amgen, if we exercise our co development option, we opt into a significant U S profit share and we are eligible for up to $460 million of development regulatory and commercial milestone payments.

Speaker Change: And ex U S royalties in the low double digit to mid teen percentage.

Speaker Change: We see this collaboration as having substantial potential to build long term value for <unk> and we look forward to making additional progress with our partner on this program.

Speaker Change: Moving now to our other drug discovery stage partnerships, we continue to make progress in our alliances, including with our newest partners Regeneron and materna.

Speaker Change: Across our lines as we have more than a dozen active discovery programs.

Speaker Change: <unk> holds significant commercial rights on a number of these assets and we have multiple near and long term milestones that were working towards.

Chris will review in a few moments the financial benefits continue to accrue to us from our partnerships as we run the company in a very capital efficient way.

Speaker Change: With that I'll hand over to Chris to provide a financial update.

Chris: Thank you Sean I am pleased to be able to share an update on our 2023 financial results with everyone today.

Chris: <unk> entered 2024 with a strong balance sheet with $175 million in cash cash equivalents and investments as of December 31, 2023, compared to $194 million at the end of 2022.

Chris: We expect our cash balance will fund the operations of the company well into the second half of 2025.

Chris: This cash guidance does not assume any additional milestones from existing collaborations or any new business development.

Chris: Both of which <unk> has a strong track record of obtaining.

Chris: Our cash position reflects our focus on controlling costs and efficient capital allocation as well as our consistent track record of funding the company through a mix of both strategic business development and equity financing over time.

Chris: Our partnerships have consistently been a strategic pathway for value creation and financing opportunities that allow us to generate non dilutive capital while increasing the reach of our platform.

Chris: Our partnerships continue to advance and have generated more than $500 million of incoming cash to date, and we see near term opportunities for additional milestone payments in 2024 and 2025.

Chris: Despite a challenging macro environment in 2023, we maintained a strong balance sheet position and executed executed efficiently to position the company to create potentially significant value inflection that will be realized over the next 12 to 18 months.

Chris: Now moving to revenue and operating expenses for the year.

Chris: Total revenue was $101 2 million for 2023 compared to $53 $2 million for the corresponding period in 2022.

We saw an increase in revenue due to a higher percentage of completion for research programs in the Bristol Myers Squibb collaboration and the recent collaborations with Regeneron and Madonna.

Chris: Operating expense for Q4, 2023 was $27 2 million compared to $29 6 million in the fourth quarter of 2022.

Chris: R&D expenses decreased by $34 3 million from last year to $77 3 million compared to $111 6 million in 2022.

Chris: General and administrative expenses decreased by $13 1 million for the year ended December 31, 2023 to $29 8 million compared to $42 $8 million for the corresponding period in 2022.

Chris: Overall, our prudent financial management, the company and focused capital allocation priorities has resulted in continued balance sheet strength as we progressed our pipeline.

Now I'll hand, the call back to Sean for closing remarks.

Thank you, Chris and thanks, everyone for your time this afternoon and for your interest in <unk>.

Sean: Twice as much for promises to be an exciting year for us in the longer term outlook for 2025 and beyond it's also very compelling as we make progress across our multi modality pipeline.

Sean: The field of antibody, marking on conditional activation is continuing to accelerate and we remain very well positioned to build on the depth of our experience as a leading innovator in this area.

Sean: We're leveraging our multi modality priority therapeutic platform to discover and develop new cancer therapies based on T cell engages adcs and cytokines each of which represents a highly relevant and timely area of strategic interest across the industry.

Sean: The <unk> team is intensely focused on delivering an innovative pipeline for the benefit of people living with cancer and I'd like to close by thanking everyone involved for their commitment to our vision.

Speaker Change: With that operator, let's go ahead, and we can open up the call for Q&A.

Speaker Change: Thank you as a reminder, if you would like to ask a question. Please press star one on your telephone.

Speaker Change: We also ask that you wait for your name and company to be announced before proceeding with your question.

One moment, while we compile the Q&A roster.

Speaker Change: Our first question today will be coming from Peter Lawson of Barclays. Your line is open.

Speaker Change: Peter Lawson Barclays. Your line is open.

Speaker Change: One moment operator, maybe we can we can put Peter back in the queue and go to the next question yes. Thank you.

Speaker Change: Our next question will be coming from Joe <unk>.

Speaker Change: Sarah.

Peter Richard Lawson: Piper Sandler your line is open.

Everybody hopefully you can hear me okay. Thanks for taking the questions and the update here.

Joe: I know we saw recent data from a competitive masking program and they showed it looked like near zero detectable Unmapped antibody in circulation just maybe can you remind us what you've historically seen.

Joe: With pro body programs around this metric, whether you're tracking FERC nano for and what your expectation would be and then maybe my follow up question is on the safety side certain preclinical tox work for 900, where I know you've reported some data around CR cri.

Joe: But <unk> worked with it for the CD three mediated talks or Egfr mediated Tau that showed up first in which with dose limiting thanks.

Speaker Change: Yeah, Hey, Joe Thanks for the questions.

Speaker Change: So we're tracking obviously all innovations in the field and all progress and.

Speaker Change: I think I think we conclude we can conclude from multiple recent datasets from several.

Speaker Change: Companies that first of all something that I think we've shown quite some time ago that marketing works.

Speaker Change: Earmarking antibodies and other.

Speaker Change: Modalities.

Speaker Change: Clearly, having showing the ability to decrease systemic target engagement and depending upon.

Speaker Change: Target and format to also improve tolerability.

Speaker Change: Our ability so we're excited to see this progress.

Speaker Change: Across across the field.

Speaker Change: What we've shown over the years pretty consistently with multiple programs.

Speaker Change: Whether it is our PD one priority or.

Speaker Change: 2009 towards C&I in some of our earlier programs from which we've learned so much.

We've shown that the vast majority of the circulating entity the priority therapeutic is.

As in mast form and that again is translated and see what we interpret as they're successful.

Speaker Change: Decreasing of of target engagement, so the fields come along way and where we are.

Speaker Change: Excited to see now in the hands of others.

Speaker Change: These types of approaches also beginning to gain some traction.

Speaker Change: In terms of our work on on Egfr CD, three and 904.

Speaker Change: We have presented me quite honestly, we haven't presented a lot of data on this program.

Speaker Change: Competitive reasons, but.

Speaker Change: We did share earlier iterations of our.

Speaker Change: <unk> III program with pretty extensive characterization instant generic animal models and in <unk>.

Speaker Change: We focused in large part on the site.

Speaker Change: Cytokine induction in those monkey studies, showing a dramatic shift.

Speaker Change: With the marketing.

Speaker Change: The dramatic shift in terms of the ability to induce cytokines, but we haven't shared a whole lot of data on the actual CX 904 molecule yet that will come in the future.

Speaker Change: Okay. Thanks.

Speaker Change: Thanks for taking my question.

Speaker Change: Youre very welcome.

Speaker Change: Thank you one moment to the next question.

Speaker Change: Our next question will be coming from <unk> Rama of Jpmorgan. Your line is open.

Speaker Change: Hi, Thank you so much for taking the question. This is actually Malcolm Kunal on for all the time.

So what is the size and scope of the phase one dose escalation data that we should be thinking about.

Speaker Change: And <unk> 24 for our CX 904.

Speaker Change: And on.

Malcolm A. Kuno: On that when we get a better sense of more a more granular timeline. Thank you.

Speaker Change: Yes, thanks for the question.

Speaker Change: So we remain on track with 900 forward too.

Speaker Change: Shared data in the second half as I mentioned in my prepared remarks, our principal objective of this moment in time is to build the dataset to share with our partner Amgen in the second half of the year and then that would result.

Speaker Change: In presentation externally in an appropriate setting.

Speaker Change: We were not.

Speaker Change: Guiding to any specifics at this point in time, obviously, what we're looking for though in phase one is to demonstrate the really fully explore the safety profile of 904 in terms of.

Speaker Change: Crs in terms of Egfr mediated toxicities.

Speaker Change: <unk> look for any early evidence of anti tumor activity and I would expect the update in the second half would be a meaningful number of patients but.

Speaker Change: That's really all that we're ready to say at this moment in time.

Speaker Change: Great. Thank you.

Thank you at this time, if you would like to ask a question. Please press star one on your telephone.

Speaker Change: There are no more questions in the queue. Thank you so much for joining the conference call today, everyone may disconnect.

Speaker Change: Okay.

Speaker Change: Goodbye.

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Speaker Change: Good day, and thank you for standing by welcome to the Cytogenetics Therapeutics fourth quarter 2023 financial results Conference call.

Speaker Change: At this time all participants are in a listen only mode.

Speaker Change: After the Speakers' presentation, there'll be a question and answer session.

To ask a question during the session you will need to press star one on your telephone.

Speaker Change: You will then hear an automated message advisor your hand is right.

Speaker Change: To ensure your question. Please press star one again.

Speaker Change: Please be advised that today's conference is being recorded.

Speaker Change: I would now like to turn the conference over to your Speaker for today, Chris Ogden Senior Vice President Finance and accounting. Please go ahead.

Chris Ogden: 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 theyre subject to inherent uncertainties and risks that are difficult to predict and many of which are outside of our <unk>.

Chris Ogden: Control.

Chris Ogden: Important risks and uncertainties are set forth in our most recent public filings with the SEC at SEC Dot Gov.

Chris Ogden: We undertake no obligation to update any forward looking statements, whether as a result of new information future developments or otherwise.

Chris Ogden: Earlier. This afternoon, we issued a press release that includes a summary of our 2023 full year financial results and highlight recent progress at <unk>. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC.

Chris Ogden: 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.

Speaker Change: With me on the call today is Dr. Sean Mccarthy, <unk>, Chief Executive Officer and Chairman.

Sean A. McCarthy: Sean will provide introductory comments on <unk> progress and key milestones before we cover our pipeline progress and financials for the fourth quarter and expectations for the year ahead with that I'll now turn the call over to Sean.

Sean A. McCarthy: Chris and good afternoon, everyone. Thanks for joining us for an update on <unk> continued progress.

Sean A. McCarthy: The promise of masking and conditional activation strategies to improve the therapeutic window for potent biologics like Adcs T cell engages and cytokines continues to be an important and exciting frontier in cancer R&D, but our leadership in this field cytomegalic derives from more than a decade.

Sean A. McCarthy: <unk> innovation with the <unk> therapeutic platform.

Sean A. McCarthy: Our foundational clinical work with the priority platform has achieved many firsts and demonstrating how marketing strategies could be effective in cancer patients and we have opened a broad field and which progress continues to accelerate.

Sean A. McCarthy: The <unk> team is highly focused on delivering on the promise of conditional activation for the benefit of patients.

Sean A. McCarthy: We're currently advancing a generation of product candidates that span multiple modalities.

Sean A. McCarthy: Leveraging validated oncology targets potent effector mechanisms and tailored marketing strategies.

Sean A. McCarthy: Each of our candidates designed to address large commercial markets and major unmet medical need in cancer.

Sean A. McCarthy: We've had a highly productive start to 2024, we remain on track for initial CX 904 phase <unk> dose escalation data in the second half of this year and we are busy launching phase one clinical trials for our newest therapeutic candidates CX 2051, and six acre one with initial phase one data anticipated.

Sean A. McCarthy: <unk> in 2025.

Sean A. McCarthy: Okay.

Sean A. McCarthy: Let me now provide additional context in detail for our lead programs.

Sean A. McCarthy: I'll start with our with CX motto for our priority T cell engagement targeting Egfr and CD three.

Sean A. McCarthy: Okay.

Sean A. McCarthy: T cell engaging bi specific antibodies have enormous potential for the treatment of cancer.

Sean A. McCarthy: And first demonstrated meaningful clinical benefit in hematologic malignancies.

Sean A. McCarthy: Looking across the T cell engage a landscape for solid tumors has taken time to see meaningful clinical results, but we're now starting to see important breakthroughs generating great excitement.

Sean A. McCarthy: Yeah.

Sean A. McCarthy: Successes include immune of course to <unk> in Uveal melanoma. The first approved T cell engaged for solid tumors and more recently Amgen starlets are mab targeting DLL, three which has demonstrated impressive results in small cell lung cancer.

Sean A. McCarthy: The development of these and other programs, there's not certainly provided long awaited proof of concepts with this important work because also helped to increasingly define a roadmap and key considerations for how to optimally develop this emerging class of potent therapies, including optimization of dosing paradigms.

Sean A. McCarthy: However for this modality to fully breakthrough in solid tumors, there is still significant challenges to overcome.

Sean A. McCarthy: T cell engagements bring very high potency in this potency can lead to toxicities in normal tissues, where the cheaper ration of interest may also be present.

Sean A. McCarthy: In fact, this is very often the case a normal tissue target expression is widely acknowledged to be a limitation on the development of T cell engages with solid tumors.

Sean A. McCarthy: Furthermore, another well acknowledged limitation for T cell engages as cytokine release syndrome, resulting from systemic binding to CD three on T cells.

Sean A. McCarthy: At <unk>, we have a broad based program focused on masking T cell engages to decreased tumor antigen binding in normal tissues and CD three binding in the periphery, thereby improving therapeutic index.

Sean A. McCarthy: We are working with partners Amgen, Astellas, Regeneron and Bristol Myers Squibb in this exciting space.

Sean A. McCarthy: Our lead program is 690 for the targets that you've ratchet Egfr CD three on T cells.

CX 904 is designed to address the principal challenges of developing an egfr CD three T cell engagement with the goal of delivering antitumor activity at tolerable systemic doses.

Sean A. McCarthy: This program is partnered with Amgen and a global co development collaboration.

Sean A. McCarthy: The market opportunity was 694 is broad there are hundreds of thousands of egfr positive patients with metastatic tumors across a wide range of cancer types that could potentially be addressed by this therapy.

Sean A. McCarthy: Cytori, which is currently conducting an ongoing phase one study in late stage unselected patients with advanced solid tumors generally known to have Egfr expression.

Sean A. McCarthy: Our principal goal for this phase I study is to evaluate safety and to identify doses and schedules for detailed evaluation and specific egfr positive cancer types in phase one b.

Sean A. McCarthy: More specifically on safety, we're looking to keep Crs and the typical egfr mediated toxicities at manageable levels in order to achieve doses in the predicted therapeutically active range.

Sean A. McCarthy: The selection of Phase one beach humor types will be driven by a combination of factors, including observations from phase one a unmet.

Sean A. McCarthy: Unmet medical need and commercial potential including fit with our partners strategic interests.

Sean A. McCarthy: We're making steady progress in the clinic, having now advanced through multiple dose cohorts of the above dose levels that would be expected to be tolerated with an unmasked Egfr T cell engagement.

Sean A. McCarthy: In late 2023, we also began to backfill certain dose levels to more fully explore the profile of this drug candidate.

Sean A. McCarthy: We expect to share initial phase one dose escalation data in the second half of 2024 with our partner Amgen and also to present these data in an appropriate setting externally.

Sean A. McCarthy: These data will inform a potential decision to initiate phase will be in 2025.

Sean A. McCarthy: Moving now to our continued work in the antibody drug conjugate space.

Sean A. McCarthy: There's been tremendous progress of Adcs in the past few years and the impact for patients has driven significant strategic interest in this field.

Sean A. McCarthy: CX 2051 is our first in class <unk> directed car body ADC.

Sean A. McCarthy: Our R&D application for <unk> thousand 51 was cleared by the FDA in January clinical study startup activities are in progress and we expect to initiate phase one dose escalation in solid tumors generally known to have at Pam expression, including colorectal cancer in the near term.

Sean A. McCarthy: They have kind of as a high potential oncology target due to its high cell surface expression in many cancer types. Indeed have cameras what are the first <unk> to be characterized more than three decades ago and it has since been implicated in many roles in cancer progression.

Sean A. McCarthy: Anti <unk> therapeutic strategies have shown potent anticancer activity in preclinical models and this has been translated into clinical activity, but to date clinical success has been limited to local administration because <unk> is present in so many normal epithelial tissues.

Sean A. McCarthy: Efforts to generate a systemically administered anti at Cam therapeutics have not been successful to date due to toxicities with epithelial tissues, including the Gi tract.

Sean A. McCarthy: Our innovative drug candidate CX 2051 is tailored to optimize the therapeutic index for <unk> expressing epithelium cancers by masking the antibody to reduce binding in normal tissues, but to allow activation and tumor tissue.

Sean A. McCarthy: We have arms the antibody with a cytotoxic payload based on Camptothecin attempt by summarize one inhibitor a class of drug that has shown potent clinical anticancer activity in the ADC context, but multiple targets leading to dramatic advances for patients.

Sean A. McCarthy: CX 2051 has demonstrated a wide predicted therapeutic index and strong preclinical activity and tolerability in multiple preclinical models, including colorectal cancer.

Sean A. McCarthy: Like Egfr I discussed previously CX 2051 could also potentially address a large patient population is that Tam is highly expressed across many indications, including colorectal gastric endometrial and ovarian cancers.

Sean A. McCarthy: Our phase one trial will follow an adaptive design and is intended to demonstrate rapid clinical proof of concept to inform a potential decision to move into dose expansion studies in 2025, we're really excited to see what this unique and first in class ADC can do for patients.

Turning now to <unk> 801, our Julie masked conditionally activated interferon alpha to be which we believe has the potential to become a cornerstone of combination immunotherapy for a wide range of tumor types.

Sean A. McCarthy: The <unk> one was cleared by the FDA in January and we expect to initiate phase one dose escalation in solid tumors.

Sean A. McCarthy: Including melanoma, renal cancer, and head and neck squamous cell carcinoma.

Sean A. McCarthy: In the first half of 2024.

Sean A. McCarthy: Interferon Alpha is a powerful cytokine with the ability to Potently drive tumor antigen presentation and activate antitumor immunity.

Sean A. McCarthy: Is demonstrated clinical activity and gained regulatory approval many years ago in multiple cancer types, including melanoma renal cancer and bladder cancer.

Sean A. McCarthy: However, interferon therapy is well known to be associated with significant systemic side effects and its use has been superceded by checkpoint inhibitors and other therapeutic approaches.

Sean A. McCarthy: It's also been shown that interferon can potentiate the clinical effects of PD, one in metastatic melanoma, but again. This approach has been limited by systemic toxicities.

Interferon therapy has recently returned to focus with Ferring pharmaceuticals approval in 2022 of its delivering an interferon alpha to be encoding gene therapy indicated for the treatment of localized BCG nonresponsive non muscle invasive bladder cancer.

Sean A. McCarthy: Reaffirming that this potent cytokine can indeed achieve robust anti tumor responses in patients.

Sean A. McCarthy: Based on the preclinical profile of CX 801, as well as prior clinical experience with interferon therapies, we see 801 as a potential new centerpiece of combination cancer immunotherapy.

Sean A. McCarthy: Our preclinical data most recently presented at 62023 demonstrates synergy for all mosques interferon alpha with PD, one inhibition, both in terms of edge tumor activity and in activation of the tumor inflammatory microenvironment.

Sean A. McCarthy: Moreover, we have also shown that systemic activity of our masters spirit is significantly reduced and overall tolerability is markedly improved compared to the unmatched cytokine in animal models.

Sean A. McCarthy: We anticipate.

Sean A. McCarthy: The opportunity that the opportunity for CSI to one will be in combination with checkpoint inhibition, where it could serve as a potent immune modulator to both increase the frequency and durability of responses in I O sensitive tumors are potentially to establish or restore efficacy in io resistant or cultures.

Sean A. McCarthy: Our phase one dose escalation trial being initiated in the first half of 'twenty 'twenty four will utilize an adaptive design to evaluate safety and signs of clinical activity for eight hour monotherapy and advanced rapidly its combination with checkpoint inhibition.

Sean A. McCarthy: Before moving to financials I would like to provide updates on our partnerships and starting with an update on our long standing collaboration with Bristol Myers Squibb.

Sean A. McCarthy: We were informed on March six of BMS intention to discontinue BMS 986 to eight eight the Cta like oil program.

Sean A. McCarthy: This unexpected decision followed a broad internal portfolio review at BMS.

We continue to work with BMS to gain more visibility on the data from this program and the factors that led to this decision.

Sean A. McCarthy: Moving forward. The BMS collaboration continues to be very active and will now focus primarily in the field of T cell engages where together we have initiated several new programs over the last two years.

Sean A. McCarthy: Notably this shift in focus within the BMS Alliance now means that the majority of our partner programs are now focused on T cell engages reflecting strong strategic interest in this area and showing that this modality modality is emerging as a key application of masking and conditional activation.

Sean A. McCarthy: Continuing the T cell engage a theme given our ongoing progress with enrollment of the CX 904 phase one <unk> study I'd like to outline some of the key terms of our strategic alliance with Amgen.

Sean A. McCarthy: Under the terms of our agreement <unk> and Amgen are co developing CX 904 sites.

Sean A. McCarthy: <unk> is responsible for early stage development, and Amgen, who will be responsible for late stage development with the transition occurring after completion of phase one b <unk>.

Sean A. McCarthy: Within the CX 904 agreement Cytogenetics has an option to participate financially in the global co development of CX nine a ball with Amgen, if we exercise our co development option, we opt into a significant U S profit share and we are eligible for up to $460 million in development regulatory and commercial milestone payments.

Sean A. McCarthy: And ex U S royalties in the low double digit to mid teen percentage.

Sean A. McCarthy: We see this collaboration as having substantial potential to build long term value for <unk> and we look forward to making additional progress with our partner on this program.

Sean A. McCarthy: Moving now to our other drug discovery stage partnerships, we continue to make progress in our alliances, including with our newest partners Regeneron and Madonna.

Sean A. McCarthy: Across our lives as we have more than a dozen active discovery programs.

Sean A. McCarthy: <unk> holds significant commercial rights on a number of these assets and we have multiple near and long term milestones that were working towards.

Sean A. McCarthy: Chris will review in a few moments the financial benefits that continue to accrue to us from our partnerships as we run the company in a very capital efficient way.

Sean A. McCarthy: With that I'll hand over to Chris to provide a financial update.

Chris Ogden: Thank you Sean I am pleased to be able to share an update on our 2023 financial results with everyone today.

Chris Ogden: <unk> entered 2024 with a strong balance sheet with $175 million in cash cash equivalents and investments as of December 31, 2023, compared to $194 million at the end of 2022.

Chris Ogden: We expect our cash balance will fund the operations of the company well into the second half of 2025.

Chris Ogden: This cash guidance does not assume any additional milestones from existing collaborations or any new business development.

Chris Ogden: Both of which <unk> has a strong track record of obtaining.

Chris Ogden: Our cash position reflects our focus on controlling costs and efficient capital allocation as well as our consistent track record of funding the company through a mix of both strategic business development and equity financing overtime.

Chris Ogden: Our partnerships have consistently been a strategic pathways for value creation and financing opportunities that allow us to generate non dilutive capital while increasing the reach of our platform.

Chris Ogden: Our partnerships continue to advance and it generated more than $500 million of incoming cash to date, and we see near term opportunities for additional milestone payments in 2024 and 2025.

Despite a challenging macro environment in 2023, we maintained a strong balance sheet position and executed executed efficiently to position the company to create potentially significant value inflections that will be realized over the next 12 to 18 months.

Chris Ogden: Now moving to revenue and operating expenses for the year.

Chris Ogden: Total revenue was $101 2 million for 2023 compared to $53 2 million for the corresponding period in 2022.

Chris Ogden: We saw an increase in revenue due to a higher percentage of completion for research programs in the Bristol Myers Squibb collaboration and the recent collaborations with Regeneron and Madonna.

Chris Ogden: Operating expense for Q4, 2023 was $27 2 million compared to $29 6 million in the fourth quarter of 2022.

Chris Ogden: R&D expenses decreased by $34 3 million from last year to $77 3 million compared to $111 6 million in 2022.

Chris Ogden: General and minimum illustrative expenses decreased by $13 1 million for the year ended December 31, 2023 to $29 8 million compared to $42 8 million for the corresponding period in 2022.

Chris Ogden: Overall, our prudent financial management of the company and focused capital allocation priorities has resulted in continued balance sheet strength as we progressed our pipeline.

Chris Ogden: Now I'll hand, the call back to Sean for closing remarks.

Sean A. McCarthy: Thank you, Chris and thanks, everyone for your time this afternoon and for your interest in <unk>.

'twenty 'twenty four promises to be an exciting year for us in the longer term outlook for 2025 and beyond it's also very compelling as we make progress across our multi modality pipeline.

Sean A. McCarthy: The field of antibody masking and conditional activation is continuing to accelerate and we remain very well positioned to build on the depth of our experience as a leading innovator in this area.

Sean A. McCarthy: We're leveraging our multi modality priority therapeutic platform to discover and develop new catheter therapies based on T cell engages adcs and cytokines each of which represents a highly relevant and timely area of strategic interest across the industry.

Sean A. McCarthy: The <unk> team is intensely focused on delivering an innovative pipeline for the benefit of people living with cancer and I'd like to close by thanking everyone involved for their commitment to our vision.

With that operator, let's go ahead, and we can open up the call for Q&A.

Speaker Change: Thank you as a reminder, if you would like to ask a question. Please press star one on your telephone.

Speaker Change: We also ask that you wait for your name and company to be announced before proceeding with your question.

Speaker Change: One moment, while we compile the Q&A roster.

Speaker Change: Our first question today will be coming from Peter Lawson of Barclays. Your line is open.

Speaker Change: Peter Lawson Barclays. Your line is open.

Speaker Change: One moment operator, maybe we can we can put Peter back in the queue and go to the next question yes. Thank you.

Speaker Change: Our next question will be coming from gel Qatar there.

Peter Richard Lawson: Piper Sandler your line is open.

Gel Qatar: Hey, everybody hopefully you can hear me okay. Thanks for taking the questions and the update here.

Gel Qatar: We saw recent data from a competitive masking program shown looked like near zero detectable Unmapped antibody in circulation just maybe can you remind us what you've historically seen with pro body programs around this metric whether you're tracking effort on our part and what your expectation would be and then.

Gel Qatar: Maybe my follow up question is on the safety side certain preclinical tox work for Dino for I know you reported some data around CR Cri.

Gel Qatar: But NGL P work with it for the CD, three mediated talked or Egfr mediated.

Gel Qatar: That showed up first in which with those preliminary thanks.

Speaker Change: Yeah, Hey, Joe Thanks for the questions yes.

Joe: So we're tracking obviously all innovations in the field and all progress and.

Speaker Change: I think I think we conclude we can conclude from multiple recent datasets from several.

Speaker Change: Companies that first of all.

Speaker Change: Something that I think we've shown quite some time ago that marketing works.

Speaker Change: Masking antibodies and other.

Speaker Change: Modalities.

Speaker Change: Clearly, having showing the ability to decrease systemic target engagement and depending upon.

Speaker Change: Target and format to also improve tolerability.

Our ability. So we're we're excited to see this progress.

Speaker Change: Across across the field.

Speaker Change: What we've shown over the years pretty consistently with with multiple programs.

Speaker Change: Whether it is our PD one property or.

Speaker Change: 2009 to its you and I and some of our earlier programs for which we've learned so much.

Speaker Change: We've shown that the vast majority of the circulating entity the priority therapeutic is.

Speaker Change: As in mast form and that again is true.

Translated and see what we interpret as they're successful.

Speaker Change: Decreasing of target engagement. So the field has come a long way.

Speaker Change: We're excited to see now in the hands of others.

Speaker Change: These types of approaches also beginning to gain some traction.

Speaker Change: In terms of our work on on Egfr CD, three and 904.

Speaker Change: We have presented at Macquarie honestly, we havent presented a lot of data on this program for various competitive reasons, but.

Speaker Change: We did share and early iteration of our.

Speaker Change: Egfr CD three program with pretty extensive characterization is in generic animal models and in <unk>.

Speaker Change: And we focused in large part on the.

Speaker Change: Cytokine induction in those monkey studies, showing a dramatic shift.

Speaker Change: With the masking.

Speaker Change: This dramatic shift in terms of the ability to induce cytokines, but we we haven't shared a whole lot of data on the actual CX 904 molecule yet that will come in future.

Speaker Change: Okay. Thanks.

Speaker Change: Helpful. Thanks for taking my question.

Speaker Change: Youre very welcome.

Speaker Change: Thank you one moment to the next question.

Speaker Change: Okay.

Speaker Change: Our next question.

Anupam Rama: Really coming from and your Pan Rama of J P. Morgan Your line is open.

Anupam Rama: Hi, Thank you so much for taking the questions was actually Malcolm Kunal on for all the time.

Malcolm A. Kuno: So what is the size and scope of the phase one dose escalation data that we should be thinking about.

Malcolm A. Kuno: And <unk> 24 for our CX nine.

<unk> Therapeutics fourth quarter 2023 financial results conference call.

Speaker Change: At this time all participants are in a listen only mode.

Speaker Change: After the Speakers' presentation, there'll be a question and answer session.

Speaker Change: To ask a question during the session you will need to press star one on your telephone.

Speaker Change: You will then hear an automated message advising your hand is right.

Speaker Change: To withdraw your question. Please press star one again.

Speaker Change: Please be advised that today's conference is being recorded.

Speaker Change: I would now like to turn the conference over to your Speaker for today, Chris Ogden Senior Vice President Finance and accounting. Please go ahead.

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 theyre subject to inherent uncertainties.

Speaker Change: And risks that are difficult to predict and many of which are outside of our control.

Speaker Change: Important risks and uncertainties are set forth in our most recent public filings with the SEC at SEC Dot Gov.

Speaker Change: We undertake no obligation to update any forward looking statements, whether as a result of new information.

Speaker Change: Future developments or otherwise.

Speaker Change: Earlier. This afternoon, we issued a press release that includes a summary of our 2023 full year financial results and highlight recent progress at <unk>.

We encourage everyone to read today's press release, and the associated materials, which have been filed with the SEC.

Speaker Change: 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.

Speaker Change: With me on the call today is Dr. Sean Mccarthy, <unk>, Chief Executive Officer, and chairman of.

Sean A. McCarthy: Sean will provide introductory comments on <unk> progress and key milestones before we cover our pipeline progress and financials for the fourth quarter and expectations for the year ahead.

Sean A. McCarthy: With that I'll now turn the call over to Sean.

Sean A. McCarthy: Thank you, Chris and good afternoon, everyone. Thanks for joining us for an update on <unk> continued progress.

Sean A. McCarthy: The promise of masking and conditional activation strategies to improve the therapeutic window for potent biologics like Adcs T cell engages and cytokines continues to be an important and exciting frontier in cancer R&D, but our leadership in this field cytogenetics derives from more than a deck.

Sean A. McCarthy: Cade of innovation with the <unk> therapeutic platform.

Sean A. McCarthy: Our foundational clinical work with the <unk> platform has achieved many firsts and demonstrating how marketing strategies could be effective in cancer patients. So we have opened a broad field and which progress continues to accelerate.

Sean A. McCarthy: The <unk> team is highly focused on delivering on the promise of conditional activation for the benefit of patients.

Sean A. McCarthy: We're currently advancing a generation of product candidates that span multiple modalities.

Sean A. McCarthy: Leveraging validated oncology targets posted effector mechanisms and tailored marketing strategies.

Sean A. McCarthy: Each of our candidates designed to address large commercial markets and major unmet medical need in cancer.

Sean A. McCarthy: We've had a highly productive start to 2024, we remain on track for initial CX 904 phase one dose escalation data in the second half of this year, but we are busy launching phase one clinical trials for our newest therapeutic candidates CX 2051, and six <unk> hundred one with initial phase one data anticipated.

Sean A. McCarthy: In 2025.

Sean A. McCarthy: Okay.

Sean A. McCarthy: Let me now provide additional context in detail for our lead programs.

Sean A. McCarthy: Start with our with <unk>, our priority T cell engagement targeting Egfr and <unk> III.

Sean A. McCarthy: T cell engaging bi specific antibodies have enormous potential for the treatment of cancer and first demonstrated meaningful clinical benefit in hematologic malignancies.

Sean A. McCarthy: Looking across the T cell engage the landscape for solid tumors has taken time to see meaningful clinical results, but we're now starting to see important breakthroughs generating great excitement.

Sean A. McCarthy: Successes include a <unk> to <unk> in Uveal melanoma. The first approved T cell engaged for solid tumors and more recently Amgen starlets are mab targeting DLL, three which has demonstrated impressive results in small cell lung cancer.

Sean A. McCarthy: The development of these and other programs so as not only provided long awaited proof of concepts, but this important work because also helped to increasingly define a roadmap and key considerations for how to optimally develop this emerging class of potent therapies.

Sean A. McCarthy: Including optimization of dosing paradigms.

Sean A. McCarthy: However for this modality to fully breakthrough in solid tumors, there is still significant challenges to overcome.

Sean A. McCarthy: T cell engagements bring very high potency in this process. He can lead to toxicities in normal tissues, where the <unk> <unk> of interest may also be present.

Sean A. McCarthy: In fact this is very often the case on normal tissue target expression is widely acknowledged to be a limitation on the development of T cell engages with solid tumors.

Sean A. McCarthy: Furthermore, another well acknowledged limitation for T cell engages as cytokine release syndrome, resulting from systemic binding to <unk> on T cells.

Sean A. McCarthy: Yeah.

Sean A. McCarthy: At <unk>, we have a broad based program focused on masking T cell engages to decreased tumor antigen binding of normal tissues and CD three binding in the periphery, thereby improving therapeutic index.

We are working with partners Amgen, Astellas, Regeneron and Bristol Myers Squibb in this exciting space.

Sean A. McCarthy: Our lead program is 690 for the targets the tumor origin Egfr CD three on T cells.

Sean A. McCarthy: CX 904 is designed to address the principal challenges of developing an egfr CD three T cell engagement with the goal of delivering anti tumor activity at tolerable systemic doses.

Sean A. McCarthy: This program is partnered with Amgen and a global co development collaborations.

Sean A. McCarthy: The market opportunity for <unk> liner for his broad there are hundreds of thousands of egfr positive patients with metastatic tumors across a wide range of cancer types that could potentially be addressed by this therapy.

Sean A. McCarthy: <unk> is currently conducting an ongoing phase <unk> study in late stage unselected patients with advanced solid tumors generally known to have Egfr expression.

Sean A. McCarthy: Our principal goal for this phase I study is to evaluate safety and to identify doses and schedules for detailed evaluation and specific egfr positive cancer types in phase one b.

Sean A. McCarthy: More specifically on safety, we're looking to keep Crs and the typical egfr mediated toxicities at manageable levels in order to achieve doses in the predicted therapeutically active range.

Sean A. McCarthy: The selection of Phase one beach humor types will be driven by a combination of factors, including observations from phase Iia unmet.

Sean A. McCarthy: Unmet medical need and commercial potential including fit with our partners strategic interests.

Sean A. McCarthy: We're making steady progress in the clinic, having now advanced through multiple dose cohorts of the above dose levels that will be expected to be tolerated with an unmatched egfr T cell engagement.

Sean A. McCarthy: In late 2023, we also began to backfill certain dose levels to more fully explore the profile of this drug candidate.

Sean A. McCarthy: We expect to share initial phase one dose escalation data in the second half of 2024 with our partner Amgen and also to present these data in an appropriate setting externally.

Sean A. McCarthy: These data will inform a potential decision to initiate phase will be in 2025.

Sean A. McCarthy: Moving now to our continued work in the antibody drug conjugate space.

This is tremendous progress in adcs in the past few years and the impact for patients has driven significant strategic interest in this field.

Sean A. McCarthy: CX 2051 is our first in class <unk> directed <unk> ADC.

Sean A. McCarthy: Our R&D application for <unk> 51 was cleared by the FDA in January clinical study startup activities are in progress and we expect to initiate phase one dose escalation in solid tumors generally known to have <unk> expression, including colorectal cancer in the near term.

Speaker Change: They have kind of as a high potential oncology target due to its high cell surface expression in many cancer types. Indeed have cameras what are the first <unk> to be characterized more than three decades ago.

Speaker Change: It has been implicated in many roles in cancer progression.

Speaker Change: Anti <unk> therapeutic strategies have shown potent anticancer activity in preclinical models and this has been translated into clinical activity, but to date clinical success has been limited to local administration because <unk> is present in so many normal epithelial tissues.

Speaker Change: Efforts to generate systemically administered anti outcome therapeutics have not been successful to date due to toxicities of epithelial tissues, including the Gi tract.

Speaker Change: Our innovative drug candidate <unk> hundred one is tailored to optimize the therapeutic index for <unk> expressing epithelium cancers by marking the antibody to reduced binding in normal tissues, but to allow activation and tumor tissue.

Speaker Change: We have arms the antibody with a cytotoxic payload based on capital discipline.

Speaker Change: Sunrise one inhibitor a class of drug that has shown potent clinical anti cancer activity in the ADC context, but multiple targets leading to dramatic advances for patients.

Speaker Change: <unk> thousand 51 has demonstrated a wide predicted therapeutic index and strong preclinical activity and tolerability in multiple preclinical models, including colorectal cancer.

Speaker Change: Like Egfr I discussed previously <unk> thousand 51 could also potentially address a large patient population is that Tam is highly expressed across many indications, including colorectal gastric endometrial and ovarian cancers.

Speaker Change: Our phase one trial will follow an adaptive design and is intended to demonstrate rapid clinical proof of concept to inform a potential decision to move into dose expansion studies in 2025, we're really excited to see what this unique and first in class ADC can do for patients.

Speaker Change: Turning now to <unk> hundred one our Julie masked conditionally activated interferon Alpha <unk>, which we believe has the potential to become a cornerstone of combination immunotherapy for a wide range of tumor types.

Speaker Change: The <unk> one was cleared by the FDA in January and we expect to initiate phase one dose escalation in solid tumors, including melanoma renal cancer and head and neck squamous cell carcinoma.

Speaker Change: In the first half of 2024.

Chris Ogden: Interferon Alpha is a powerful cytokine with the ability to Potently drive tumor antigen presentation and activate antitumor immunity.

Chris: As demonstrated clinical activity and gained regulatory approval many years ago in multiple cancer types, including melanoma renal cancer and bladder cancer.

Chris: However, interferon therapy is well known to be associated with significant systemic side effects and its use has been superceded by checkpoint inhibitors and other therapeutic approaches.

Chris: It's also been shown that interferon could potentiate the clinical effects of PD, one in metastatic melanoma, but again. This approach has been limited by systemic toxicities.

Chris: Interferon therapy has recently returned to focus with Ferring pharmaceuticals approval in 2022 of us delivering an interferon alpha <unk> encoding gene therapy indicated for the treatment of localized BCG nonresponsive non muscle invasive bladder cancer.

Chris: Reaffirming that this potent cytokine can indeed achieve robust anti tumor responses in patients.

Chris: Based on the preclinical profile of CX 801, as well as prior clinical experience with interferon therapies, we see 801 as a potential new centerpiece of combination cancer immunotherapy.

Chris: Our preclinical data most recently presented at <unk> 2023 demonstrates synergy for our Marston different Alco with PD, one inhibition, both in terms of edge tumor activity and in activation of the tumor inflammatory microenvironment.

Chris: Moreover, we have also shown that systemic activity of our Marston spirit is significantly reduced and overall tolerability is markedly improved compared to the unmatched cytokine in animal models.

Chris: We anticipate.

Chris: The opportunity the opportunity for <unk> hundred one will be in combination with checkpoint inhibition, where it could serve as a potent immune modulator to both increase the frequency and durability of responses and Io sensitive tumors are potentially to establish or restore efficacy and io resistant or cold tumors.

Chris: Our phase one dose escalation trial being initiated in the first half of 'twenty 'twenty four will utilize an adaptive design to evaluate safety and signs of clinical activity for eight hour monotherapy and advanced rapidly its combination with checkpoint inhibition.

Chris: Before moving to financials I would like to provide updates on our partnerships and starting with an update on our long standing collaboration with Bristol Myers Squibb.

Chris: We were informed on March six of BMS intention to discontinue BMS $960 eight eight the <unk> program.

Chris: This unexpected decision followed a broad internal portfolio review at BMS.

Chris: We continue to work with BMS to gain more visibility on the data from this program and the factors that led to this decision.

Chris: Moving forward. The BMS collaboration continues to be very active and we will now focus primarily in the field of T cell engagements, where together we have initiated several new programs over the last two years.

Sean A. McCarthy: Notably this shift in focus within the BMS Alliance now means that the majority of our partner programs are now focused on T cell engagements, reflecting strong strategic interest in this area and showing that this modality modality is emerging as a key application of masking and conditional activation.

Sean: Continuing the T cell engaged theme given our ongoing progress with enrollments of the CX 904 phase one <unk> study I'd like to outline some of the key terms of our strategic alliance with Amgen.

Sean: Under the terms of our agreement Cytogenetics and Amgen are co developing CX 904 sites.

Sean: <unk> is responsible for early stage development and Amgen will be responsible for late stage development with the transition occurring after completion of phase one b <unk>.

Sean: Within the CX 904 agreement side. So it makes us an option to participate financially in the global co development of CX 904, with Amgen, if we exercise our co development option, we opt into a significant U S profit share and we are eligible for up to $460 million in development regulatory and commercial milestone payments.

Speaker Change: And ex U S royalties in the low double digit to mid teen percentage.

Speaker Change: We see this collaboration as having substantial potential to build long term value for <unk> and we look forward to making additional progress with our partner on this program.

Speaker Change: Moving now to our other drug discovery stage partnerships, we continue to make progress in our alliances, including with our newest partners Regeneron and materna.

Speaker Change: Across our lines as we have more than a dozen active discovery programs.

Speaker Change: <unk> holds significant commercial rights on a number of these assets and we have multiple near and long term milestones that were working towards.

Speaker Change: Chris will review in a few moments the financial benefits that continue to accrue to us from our partnerships as we run the company in a very capital efficient way.

Speaker Change: With that I'll hand over to Chris to provide a financial update.

Chris Ogden: Thank you Sean I am pleased to be able to share an update on our 2023 financial results with everyone today.

Joe: <unk> entered 2024 with a strong balance sheet with $175 million in cash cash equivalents and investments as of December 31, 2023, compared to $194 million at the end of 2022.

Joe: We expect our cash balance will fund the operations of the company well into the second half of 2025.

Joe: This cash guidance does not assume any additional milestones from existing collaborations or any new business development.

Joe: Both of which <unk> has a strong track record of obtaining.

Joe: Our cash position reflects our focus on controlling costs and efficient capital allocation as well as our consistent track record of funding the company through a mix of both strategic business development and equity financing over time.

Speaker Change: Our partnerships have consistently been a strategic pathway for value creation and financing opportunities that allow us to generate non dilutive capital while increasing the reach of our platform.

Speaker Change: Our partnerships continue to advance and have generated more than $500 million of incoming cash to date, and we see near term opportunities for additional milestone payments in 2024 and 2025.

Speaker Change: Despite a challenging macro environment in 2023, we maintained a strong balance sheet position and executed executed efficiently to position the company to create potentially significant value inflection that will be realized over the next 12 to 18 months.

Speaker Change: Now moving to revenue and operating expenses for the year.

Speaker Change: Total revenue was $101 2 million for 2023 compared to $53 $2 million for the corresponding period in 2022.

Speaker Change: We saw an increase in revenue due to a higher percentage of completion for research program in the Bristol Myers Squibb collaboration and the recent collaborations with Regeneron and the journey.

Speaker Change: Operating expense for Q4, 2023 was $27 2 million compared to $29 6 million in the fourth quarter of 2022.

R&D expenses decreased by $34 3 million from last year to $77 3 million compared to $111 6 million in 2022.

Speaker Change: General and administrative expenses decreased by $13 1 million for the year ended December 31, 2023 to $29 8 million compared to $42 8 million for the corresponding period in 2022.

Speaker Change: Overall, our prudent financial management of the company and focused capital allocation priorities has resulted in continued balance sheet strength as we progressed our pipeline.

Speaker Change: Now I'll hand, the call back to Sean for closing remarks.

Sean A. McCarthy: Thank you, Chris and thanks, everyone for your time this afternoon and for your interest in <unk>.

Sean A. McCarthy: <unk> had four promises to be an exciting year for us in the longer term outlook for 2025 and beyond it's also very compelling as we make progress across our multi modality pipeline.

Rama: The field of antibody, marking and conditional activation is continuing to accelerate and we remain very well positioned to build on the depth of our experience as a leading innovator in this area.

Malcolm A. Kuno: We're leveraging our multi modality priority therapeutic platform to discover and develop new cancer therapies based on T cell engages adcs and cytokines each of which represents a highly relevant and timely area of strategic interest across the industry.

Malcolm A. Kuno: The <unk> team is intensely focused on delivering an innovative pipeline for the benefit of people living with cancer and I'd like to close by thanking everyone involved for their commitment to our vision.

Speaker Change: With that operator, let's go ahead, and we can open up the call for Q&A.

Speaker Change: Thank you as a reminder, if you would like to ask a question. Please press star one on your telephone.

Speaker Change: We also ask that you wait for your name and company to be announced before proceeding with your question.

Speaker Change: One moment, while we compile the Q&A roster.

Speaker Change: Our first question today will be coming from Peter Lawson of Barclays. Your line is open.

Speaker Change: Peter Lawson Barclays. Your line is open.

Speaker Change: One moment operator, maybe we can we can put Peter back in the queue and go to the next question yes. Thank you.

Speaker Change: Our next question will be coming from Joe <unk>.

Speaker Change: Sure.

Peter Richard Lawson: Piper Sandler your line is open.

Joe: Hey, everybody hopefully you can hear me okay. Thanks for taking the questions and the update here.

Joe: So I know we saw recent data from a competitive masking program and Shouldnt look like near zero detectable Unmapped antibody in circulation.

Speaker Change: Can you remind us what you've historically seen with pro body programs around this metric, whether you're tracking FERC <unk> and what your expectation would be and then maybe my follow up question is on the safety side certain preclinical tox work for non op or I know you've reported some data around CR cri.

Speaker Change: But <unk> worked with it for the CD three mediated talks or Egfr mediated Tau.

Speaker Change: <unk> first and which was with dose limiting thanks.

Speaker Change: Yeah, Hey, Joe Thanks for the questions.

Joe: So we're tracking obviously all innovations in the field and all progress.

Speaker Change: I think I think we conclude we can conclude from multiple recent datasets from several.

Speaker Change: Companies that first of all something that I think we've shown in quite some time ago that marketing works.

Speaker Change: Earmarking antibodies and other.

Speaker Change: Modalities.

Speaker Change: Clearly, having showing the ability to decrease systemic target engagement and depending upon.

Speaker Change: Target and format to also improve tolerability.

Speaker Change: Our ability so we're excited to see this progress.

Speaker Change: Across across the field.

What we've shown over the years pretty consistently with multiple programs.

Speaker Change: Whether it is our PD one property or.

Speaker Change: 2009 towards some of our earlier programs from which we've learned so much.

Speaker Change: We've shown that the vast majority of the circulating entity the priority therapeutic is.

Speaker Change: As in mast form and that again is translated and see what we interpret as they're successful.

Speaker Change: Decreasing of of target engagement, so the fields come along way and where we are.

Speaker Change: Excited to see now in the hands of others.

Speaker Change: These types of approach is also beginning to gain some traction.

Speaker Change: In terms of our work on Egfr CD, three and 904.

Speaker Change: We have presented me quite honestly, we haven't presented a lot of data on this program.

Speaker Change: Competitive reasons, but.

Speaker Change: We did share earlier iterations of our.

Speaker Change: <unk> III program with pretty extensive characterization instant generic animal models and in <unk>.

Speaker Change: We focused in large part on the site.

Speaker Change: Cytokine induction in those monkey studies, showing a dramatic shift.

Speaker Change: With the marketing.

Speaker Change: The dramatic shift in terms of the ability to induce cytokines, but we haven't shared a whole lot of data on the actual CX 904 molecule yet that will come in the future.

Speaker Change: Okay. Thanks.

Speaker Change: Helpful. Thanks for taking my question.

Speaker Change: Youre very welcome.

Speaker Change: Thank you one moment for the next question.

Speaker Change: Our next question will be coming from <unk> Rama of Jpmorgan. Your line is open.

Rama: Hi, Thank you so much for taking the questions was actually Malcolm Kunal on for all the time.

Malcolm A. Kuno: So what is the size and scope of the phase one dose escalation data that we should be thinking about.

Speaker Change: And <unk> 24 for our CX 904.

Speaker Change: And.

Malcolm A. Kuno: On that when we get a better sense of more.

Speaker Change: More granularly timeline. Thank you.

Speaker Change: Yes, thanks for the question.

Speaker Change: So we remain on track with 900 forward too.

Speaker Change: The shared data in the second half as I mentioned in my.

Speaker Change: Prepared remarks, our principal objective of this moment in time is to build a dataset to share with our partner Amgen in the second half of the year and then that would result.

Speaker Change: In presentation externally in an appropriate setting.

We were not.

Speaker Change: Guiding to any specifics at this point in time, obviously, what we're looking for though in phase one is to demonstrate the <unk>.

Speaker Change: Really fully explore the safety profile of 904 in terms of.

Speaker Change: Crs in terms of Egfr mediated toxicities.

Speaker Change: Obviously look for any early evidence of anti tumor activity.

Speaker Change: Expect the update in the second half would be a meaningful number of patients but.

Speaker Change: That's really all that we're ready to say at this moment in time.

Speaker Change: Great. Thank you.

Speaker Change: Thank you at this time, if you would like to ask a question. Please press star one on your telephone.

Speaker Change: There are no more questions in the queue. Thank you so much for joining the conference call today, everyone may disconnect.

Q4 2023 CytomX Therapeutics Inc Earnings Call

Demo

CytomX Therapeutics

Earnings

Q4 2023 CytomX Therapeutics Inc Earnings Call

CTMX

Monday, March 11th, 2024 at 9:00 PM

Transcript

No Transcript Available

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