Q4 2021 CytomX Therapeutics Inc Earnings Call
Good afternoon, everyone. Thank you for standing by welcome to this iconic therapeutics fourth quarter and full year 2021 financial results call. Please be advised that todays call is being recorded.
Operator: Good afternoon, everyone. Thank you for standing by. Welcome to the CytomX Therapeutics fourth quarter and full year 2021 financial results call. Please be advised that today's call is being recorded. I would now like to hand the call over to your host today, Chow Ching, CytomX's Vice President, Investor Relations, and Corporate Communications. Please go ahead.
Now like to hand, the call over to your host today Chau Cheng Titanic says Vice President Investor Relations and corporate Communications. Please go ahead.
Thank you Michelle good.
Chow Ching: Thank you, Michelle. Good afternoon, and thank you for joining us. With me today are Dr. Sean McCarthy, CytomX Chief Executive Officer and Chairman, Dr. Amy Peterson, President and Chief Operating Officer, and Chris Ogden, Vice President, Finance and Accounting. Earlier today, we issued a press release that includes a summary of our fourth quarter and full year 2021 financial results and highlights the important progress we made during the year. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC.
Afternoon, and thank you for joining US with me today is Sean Mccarthy.
Chow Ching: Additionally, the press release and recording of this call can be found in the investors and news section of our website at CytomX.com. Please note that during today's call, we will be making forward-looking statements. This is a big doable error; you can control all things with only your smart phones. So why touch the smart phones? Because... You willingly do not need to; you, um, can determine that you do not need to.
Chief Executive Officer, and chairman of the <unk>.
Peterson, President and Chief operating Officer increased.
Vice President finance and accounting earlier.
Earlier today, we issued a press release that includes a summary of our fourth quarter and full year 2021 financial results and highlight the important progress we made during the year. We encourage everyone to read today's press release and the associated materials, which have been filed with the SEC.
Additionally, the press release and a recording all these cool can be found under the investors and news section of our website.
I will make that call.
Please note that during today's call, we will be making forward looking statements because forward looking statements relate to the future theyre subject to inherent uncertainties and risks.
The uncertainty surrounding the COVID-19 pandemic.
<unk> to predict and many of which are outside of our control.
Chow Ching: This is why you buy a smart phone. If your phone is in the market, great for you. If your Imoji is too big a profile pic, I would recommend you buy a third-party ight and make sure it has the same quality as it.
Portland.
And uncertainties are set forth in our most recent public filings with the SEC.
<unk> Dot Gov.
Chow Ching: In the future, this product is only available in China. Down the line, there are a lot of deeper topics to pick up regarding the future, too, including the uncertainty surrounding the COVID-19 pandemic that are difficult to predict and many of which are outside of our control. Important risks and uncertainties are set forth in our most recent public filings with the SEC at SEC.gov, including our Form 10K files 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.
Our Form 10-K filed today.
Undertakes no obligation to update any forward looking statements, whether as a result of new information future developments or otherwise with that I would like to turn the call now over to Sean.
Thanks, Joe and good afternoon, everyone. Thanks for joining us today for an update on recent progress at <unk>.
Sean Mccarthy: Thanks, Chau, and good afternoon everyone. Thanks for joining us today for an update on recent progress at CytomX. Before I begin, I'd like to note that on February 14th, we issued an 8K announcing that our Chief Financial Officer, Carlos Campoy, has begun a temporary personal leave of absence. We very much look forward to Carlos' return.
Sean Mccarthy: In the interim, our Vice President of Finance, Chris Ogden, who joins us on the call today, has assumed the role of Principal Accounting Officer and will oversee day-to-day operations of our finance functions. I would also like to congratulate Amy on her recent promotion to President and Chief Operating Officer of CytomX. An expanded role in which she will have responsibility for all aspects of product development as we advance towards potential registrational studies and beyond.
Before I begin I'd like to note that on February 14, we issued an 8-K announcing that our chief financial Officer Carlos Campoy.
<unk> begun a temporary personal leave of absence, we very much look forward to Carlos return in.
In the interim Vice President of Finance, Chris <unk>, who joins us on the call today has assumed the role of principal accounting officer and will oversee day to day operations of our finance functions.
I would also like to congratulate Amy on his recent promotion to President and Chief operating officer of sites.
It expanded role in which he will have responsibility for all aspects of product development as we advance towards potential Registrational studies and beyond.
I would like to start today's call by taking a step back to comment on our overarching corporate strategy.
Sean Mccarthy: I would like to start today's call by taking a step back to comment on our overarching corporate strategy and to reflect on our many accomplishments over the past year resulting from sustained and relentless execution by the CytomX team. I'll then hand the call over to Amy to provide updates on our broad and increasingly mature therapeutic pipeline. CytomX is a clinical stage oncology-focused biopharmaceutical company dedicated to destroying cancer differently. We are utilizing our industry-leading, proprietary pro-body platform to create biologic therapeutics to make the biggest possible difference we can for the lives of people with cancer. Our ambition is to build a long-term, multi-product, commercial biopharmaceutical company.
I have to reflect on our many accomplishments over the past year, resulting from sustained and relentless execution by the <unk> team.
I will then hand, the call over to Amy to provide updates on our broad and increasingly mature therapeutic pipeline.
<unk> is a clinical stage oncology focused biopharmaceutical company dedicated to destroying cancer differently.
We are utilizing our industry, leading proprietary property platform to create biologic therapeutics to make the biggest possible difference we can to the lives of people with cancer.
Our ambition is to build a long term multi product commercial biopharmaceutical company.
Our innovative platform is designed to enable conditional activation of therapeutic candidates within the tumor microenvironment.
Sean Mccarthy: Our innovative platform is designed to enable conditional activation of therapeutic candidates within the tumor microenvironment, minimizing drug activity in healthy tissues, resulting in more selective targeting of tumor tissue. We have established conditional activation as a strategic area of current biologics research and development in the industry. We believe our innovative approach has the potential to improve cancer treatment in three ways. Firstly, it allows the pursuit of high-potential targets that were previously considered undruggable due to their ubiquitous expression in normal tissues.
<unk> drug activity in healthy tissues, resulting in more selective targeting of tumor tissue.
We have established conditional activation as a strategic area of current biologics research and development in the industry.
We believe our innovative approach has the potential to improve cancer treatment in three ways.
Sean Mccarthy: Secondly, enhancing a potential product's therapeutic window, the balance between tolerability and anti-tumor activity, with particular focus on potent immunotherapies. And thirdly, enabling the development of new combination therapies, including immunotherapies, by improving tolerability. We are employing our platform to address some of the biggest challenges today in oncology biologics R&D. These include the validation of potential new targets for antibody drug conjugates. Opening Solid Tumor Opportunities for T-Cell Engaging Bispecific Antibodies and increasing the therapeutic window for immune modulators such as cytokines and checkpoint inhibitors
Firstly, allowing the pursuit of high potential targets that were previously considered undruggable due to their ubiquitous expression on normal tissues.
Secondly, enhancing our potential products therapeutic window, the balance between Tolerability and anti tumor activity with particular focus on potent immunotherapies.
And thirdly, enabling the development of new combination therapies, including Immunotherapies by improving Tolerability.
We are employing our platform to address some of the biggest challenges today in oncology biologics R&D.
These include the validation of potential new targets for antibody drug conjugates.
Opening solid tumor opportunities with T cell engaging by specific antibodies.
And increasing the therapeutic window for immune modulators, such as cytokines and checkpoint inhibitors.
We have utilized our multi modality priority platform to build a deep clinical pipeline that now encompasses six novel product candidates four of which are currently at multiple phase II clinical studies across nine cancer types.
Sean Mccarthy: We have utilized our multi-modality pro-body platform to build a deep clinical pipeline that now encompasses six novel product candidates, four of which are currently in multiple phase two clinical studies across nine cancer types. The breadth, depth, and range of our pipeline is unmatched in the field of conditional activation.
The breadth depth and range of our pipeline is unmatched in the field of conditional activation, we have treated more than 400 patients with property therapeutics and we have proved key translational questions in the clinic to validate the performance of our platform and we continue to add to our strong intellectual property portfolio, which now comprises over 550 issued.
Sean Mccarthy: We have treated more than 400 patients with ProBody Therapeutics, and we have probed key translational questions in the clinic to validate the performance of our platform. And we continue to add to our strong intellectual property portfolio, which now comprises over 550 issued and pending patents.
And pending patents.
Our product candidates include the conditionally activated adcs, probably is that's about <unk>, <unk>, which targets the CD 166, and CX two zero to nine which targets <unk> 71.
Sean Mccarthy: Our product candidates include the conditionally activated ADCs Pralizatamab-Raftanzine, which targets CD166, and CX2029, which targets CD71. These phase two clinical programs highlight our strategy of leveraging our technology to pursue high potential, previously undruggable targets. Our pipeline also encompasses the anti-CTLA-4 pro-body, BMS-986249, and the pro-body immune checkpoint inhibitor, Pacmilimab, targeting PD-L1, both of which are also in phase 2 studies. These product candidates highlight our strategy of using the ProBody platform to improve the therapeutic window for potent immunotherapies, broadening the clinical utility of these important pathways.
These phase II clinical programs highlights our strategy of leveraging our technology to pursue high potential previously undruggable targets.
Our pipeline also encompasses the ITC TAA full pro body BMS 986 to 49, and the property immune checkpoints inhibitor <unk> targeting PD L. One.
Both of which are also in phase II studies.
These product candidates highlights our strategy of using the <unk> platform to improve therapeutic window for potent immunotherapies broadening the clinical utility of these important pathways.
In addition to our phase II programs are versatile and tunable platform has continued to deliver new product candidates for advancement into the clinic.
Sean Mccarthy: In addition to our phase two programs, our versatile and tunable platform has continued to deliver new product candidates for advancement into the clinic. CX904 is our first conditionally activated T cell engaging bispecific antibody targeting EGFR on tumor cells and the CD3 receptor on T cells.
CX 904, as our first conditionally activated T cell engaging bi specific antibody targeting egfr on tumor cells and the CD three receptor on T cells.
Sean Mccarthy: In January 2022, the IND for this program was cleared by the FDA, and we're in the process of initiating a first-in-human Phase I study in patients with advanced solid tumors. Our integrated corporate strategy has and continues to encompass the formation of major partnerships with pharmaceutical and biotechnology companies. To date, we have formed multiple strategic alliances with major multinational pharmaceutical companies, including AbbVie, Amgen, Astellas, and Bristol-Myers Squibb. These alliances not only broaden the impact of our technology platform by increasing the number of pro-body therapeutic candidates being advanced into clinical studies. But they have also added considerable financial resources in the form of non-dilutive capital, enabling us to consistently maintain balance sheet strength over the years.
In January 2022, the IND for this program was cleared by the FDA and we're in the process of initiating our first in human Phase one study in patients with advanced solid tumors.
Our integrated corporate strategy has and continues to encompass the formation of major partnerships with pharmaceutical and biotechnology companies.
To date, we have formed multiple strategic alliances with major multinational pharma companies, including Abbvie, Amgen, Astellas and Bristol Myers Squibb.
These alliances not only broaden the impact of our technology platform by increasing the number of properties therapeutic candidates being advanced into clinical studies.
But they've also added considerable financial resources form of non dilutive capital, enabling us to consistently maintain balance sheet strength over the years.
Today, we have reported a 2021 year end cash balance of $305 million.
Sean Mccarthy: Today, we have reported a 2021 year-end cash balance of $305 million, which provides funding well into 2023 without taking into account any potential cash flows from existing or new partnerships. Chris will provide you with an overview of our financials momentarily. Our successful financing of CytomX coupled with our prudent financial management has allowed us to aggressively advance our pipeline to key upcoming milestones and value inflection points and to build a broad early-stage pipeline that extends beyond our six clinical-stage assets as we continue to innovate and reinforce our lead in the field of conditional activation. I will now hand the call over to Amy to walk through our many exciting achievements in the pipeline in 2021 and also our outlook for Thank you, Sean.
Which provides funding well into 2023 without taking into account any potential cash flows from existing or new partnerships.
Chris will provide you with an overview of our financials momentarily.
Our successful financing of <unk>, coupled with our prudent financial management has allowed us to aggressively advance our pipeline to key upcoming milestones and value inflection points and to build a broad early stage pipeline that extends beyond our six clinical stage assets as we continue to innovate and reinforce our lead in the field of conditional activation.
Let me now hand, the call over to Amy to walk through our many exciting achievements in the pipeline in 2021 and also our outlook for 2020, Thanks, Sean I am very excited about the progress we are making at say telmex and look forward to continuing to deliver on our goal of building our company for the long term.
Amy Peterson: I am very excited about the progress we are making at CytomX and look forward to continuing to deliver on our goal of building our company for the long term and making our promise to positively impact the lives of people with cancer. In 2021, we made significant advancements despite contending with the COVID-19 pandemic. Let me begin with Prelizetamab-Tanzane, our wholly-owned Phase II asset. As Sean mentioned, Prelizetamab is a CD166-directed, conditionally-activated ADC with first-in-class potential in breast cancer, and we recently published full data from our phase one monotherapy dose escalation study in clinical cancer research. In this paper, we reported encouraging anti-cancer activity in patients with either triple negative or hormone receptor positive HER2 non-amplified breast cancer.
And making real our promise to positively impact the lives of people with cancer.
In 2021, we made significant advancements despite contending with the COVID-19 pandemic.
Amy Peterson: In particular, the clinical benefit rate defined as any partial or complete response or stable disease at 16 or 24 weeks was 41% and 28%, respectively, and despite a median of 7 prior therapy. The treatment landscape in breast cancer continues to evolve, especially in the area of ADCs, with the recent results from the DESTINEO3 study evaluating trastuzumab-Durex-Tcan in patients with HER2-low breast cancer and, of course, the anticipated Phase 3 results from sasituzumab in patients with hormone receptor-positive breast cancer.
Let me begin with <unk>, our wholly owned phase two asset.
As Sean mentioned prelude that map is a CD 166, directed conditionally activated ADC with first in class potential in breast cancer and we recently published full data from our phase one monotherapy dose escalation study in clinical cancer research.
In this paper, we reported encouraging anti cancer activity in patients with either triple negative or hormone receptor positive her two non amplified breast cancer.
In particular, the clinical benefit rate defined as any partial or complete response or stable disease at 16, or 24 weeks with 41% and 28% respectively and despite a median of seven prior therapy.
The treatment landscape in breast cancer continues to evolve, especially in the area of ADC with the recent results from the Destiny <unk> III study evaluating trastuzumab, Derrick pecan and patients with her two low breast cancer and of course, the anticipated phase III results from <unk> in patients with hormone.
<unk> positive breast cancer.
Amy Peterson: ADCs are clearly making an impact in breast cancer, and we are excited about the potential for prelizetamab. Let me discuss the design of our ongoing Phase 2 study in a bit more detail. The tolerability and activity of prelizatinib monotherapy are being assessed in arms A and B in approximately 40 efficacy-evaluable patients with either hormone receptor positive disease or triple negative disease, respectively.
<unk> Adcs are clearly, making an impact in breast cancer and we are excited about the potential for <unk>.
Amy Peterson: Our enrollment criteria in all arms exclude patients with HER2-amplified breast cancer, meaning we are enrolling patients with either HER2-low or HER2-null breast cancer, the latter being a sizable population that is not addressed by TRAS2's Mevderex TK. The primary endpoint in all arms is response rate by central radiology review, and the key secondary endpoint, particularly important for arm A, is CBR 24 The definition of efficacy of valuable includes high expression of CD166.
Let me discuss the design of our ongoing phase II study in a bit more detail.
The tolerability and activity of <unk> monotherapy is being assessed in arms, a and b and approximately 40 efficacy evaluable patients with either hormone receptor positive disease or triple negative disease, respectively.
Our enrollment criteria in all arms in.
<unk> patients with her two amplified breast cancer, meaning we are enrolling patients with either her too low or hurts you know breast cancer, the latter being a sizeable population that is not addressed by Trastuzumab Derek can.
The primary endpoint in all arms as response rate by Central Radiology review and the key secondary endpoint, particularly important for RMA is CBR 24.
The definition of efficacy Evaluable includes high expression of <unk> 166.
Amy Peterson: Of note, our phase one experience with hormone receptor positive disease showed high CD166 expression in more than 90% of patients, and arm A is an unselected population. For TNBC, we saw more heterogeneous expression levels in Phase 1, and for this reason, we're selecting patients for CD166 expression. Enrollment into the trial continues at over 40 sites globally, and we anticipate having initial data in arms A and B in the second half of 2022.
Of note our phase one experience with hormone receptor positive disease showed high CD 166 expression and more than 90% of patients in arm and arm a is an unselected population.
For <unk>, we saw more heterogeneous expression levels in phase one and for this reason, we're selecting patients for CD 166 expression.
Enrollment into the trial continues at over 40 sites globally, and we anticipate having initial data in arms, a and b in the second half of 2022.
Let's now move to RMC, which is evaluating the combination of <unk> and Pac mill, a map our PDL one pro body in patients with PD Lone positive CD 166, expressing triple negative breast cancer.
Amy Peterson: Let's now move to ArmC, which is evaluating the combination of prelizatamab and pacmilimab, our PD-L1 pro-body, in patients with PD-L1 positive, CD166 expressing triple negative breast cancer. Each agent has shown single agent activity in triple negative breast cancer, and we are excited to see what this combination can do for patients.
Each agent has shown single agent activity in triple negative breast cancer and we are excited to see what this combination can do for patient enrollment is ongoing and we expect results from this arm to be available in 2023.
Amy Peterson: Enrollment is ongoing, and we expect results from this arm to be available in 2023. I would now like to discuss CX2029. Our program assessing the anti-CD71 ADC in partnership with AbbVie. To briefly recap,
I would now like to discuss CX <unk> two nine.
Our program assessing the anti CD 71, ADC in partnership with Abbvie.
To briefly recap.
In December 2021, we reported encouraging results for our ongoing phase two expansion of this program in patients with late stage metastatic squamous non small cell lung cancer, an area of high unmet.
Amy Peterson: In December 2021, we reported encouraging results for our ongoing Phase 2 expansion of this program in patients with late-stage metastatic squamous non-small cell lung cancer, an area of high unmet clinical need. Specifically, we reported a preliminary response rate of 18.8% and a disease control rate of 87.5% in 16 patients with squamous lung cancer who had received both prior platinum-based treatment and checkpoint inhibition. This is a growing patient population with a high unmet need.
Clinical need specifically, we reported our preliminary response rate of 18, 8% and a disease control rate of 87, 5% and 16 patients with squamous lung cancer, who had received both prior platinum based treatment and checkpoint inhibition.
This is a growing patient population with a high unmet need.
Amy Peterson: To put these preliminary monotherapy results into context, several randomized studies conducted in the second or third line squamous lung setting reported a response rate to docetaxel between eight and 11%. This response rate is in patients who are checkpoint inhibitor naive. As an additional reference point, nivolumab, approved by the FDA in 2015 for the treatment of patients with previously treated metastatic squamous non-small cell lung cancer as monotherapy, reported a response rate of 12.8% in the third-line setting.
To put these preliminary monotherapy results into context, several randomized studies conducted in the second or third line squamous lung setting report a response rate to docetaxel between eight and 11%.
This response rate is in patients who are checkpoint inhibitor naive.
As an additional reference point Navarro map approved by the FDA in 2015 for the treatment of patients with previously treated metastatic squamous non small cell lung cancer as monotherapy reported a response rate of 12, 8% in the third line setting.
Given the prior treatment regimens in our study and the unselected nature of the study population. We are encouraged by the activity enrollment continues towards our goal of 25 efficacy evaluable patients and we expect to provide a data update on all efficacy evaluable patients in the second half of 2022.
Amy Peterson: Given the prior treatment regimens in our study and the unselected nature of the study population, we are encouraged by the activity. Enrollment continues towards our goal of 25 efficacy-evaluable patients, and we expect to provide a data update on all efficacy-evaluable patients in the second half of 2022. To briefly recap, both prelozacumab and CX2029 are first-in-class, conditionally activated ADCs directed against tumor targets that were previously deemed undruggable, a core element of our strategy to destroy cancer differently.
To briefly recap, both <unk> and <unk>, our first in class conditionally activated adcs directed against tumor targets that were previously deemed undruggable.
Core element of our strategy to destroy cancer differently.
Amy Peterson: I'd like to now turn our efforts to use our platform to improve the therapeutic window for potential immunotherapies, starting with CTLA-4 and BMS-986249, the pro-body version of ipilimumab we created with our partner, Bristol-Myers Squibb. CTLA-4 targeted therapy is a foundational immuno-oncology strategy, and Treatment with Ipilimumab as a monotherapy or in This is highlighted by the recently updated median overall survival of 72.1 months for the combination in the Phase III Melanoma Checkmate 067 study.
I'd like to now turn our efforts to use our platform to improve the therapeutic window for potential immunotherapy, starting with <unk> four and BMS 96 to four nine the pro body version, if aluminum Mab, we created with our partner Bristol Myers Squibb.
<unk> four targeted therapy as a foundational immuno oncology strategy and treatment with <unk> as a monotherapy or in combination with Nevada and that has resulted in clinically meaningful antitumor activity in a variety of malignancies highlighted by the recently updated median overall survival of.
72, one months for the combination in the phase III melanoma Checkmate <unk> seven study.
The durability of responses to anti <unk> four therapy continues to highlight the importance and uniqueness of this target.
Amy Peterson: The durability of responses to anti-CTLA-4 therapy continues to highlight the importance and uniqueness of this target. However, CTLA-4 blockade has a narrow therapeutic window, and we believe that broader potential of CTLA-4 therapy could be realized through the application of our ProBody platform. We believe our CTLA-4 targeting pro-body therapeutic may be able to effectively localize the anti-CTLA-4 antibody activity to the tumor microenvironment, thereby limiting systemic toxicities often seen with ipilimumab, potentially improving the benefit-risk profile of an anti-CTLA-4-containing regimen.
However, <unk> four blockade has a narrow therapeutic window and we believe that broader potential of Cts law for therapy could be realized through the application of our <unk> platform. We believe our <unk> four targeting probiotic therapeutic may be able to effectively localize the anti <unk> four.
Our antibody activity to the tumor microenvironment.
Thereby limiting systemic toxicities, often seen with aluminum that potentially improving the benefit risk profile of an anti <unk> four containing regimen.
The phase one study conducted by BMS and previously reported at <unk> 2020 evaluated doses of BMS 986 to 49 monotherapy that were equivalent to up to 30 milligrams per kilogram of unmatched at the aluminum app.
Amy Peterson: The Phase 1 study conducted by BMS and previously reported at ASCO 2020 evaluated doses of BMS 986249 monotherapy that were equivalent to up to 30 mg per kg of unmasked ipilimumab and, in combination with 480 milligrams of nivolumab, doses that were equivalent to up to 15 milligrams per kilogram of unmasked ipilimumab. This is remarkable in that a dose of 3 mg per kg of ipilimumab was not tolerable in combination with an equivalent dose of nivolumab, as shown in a 2013 Phase 1 study reported in the New England Journal.
And in combination with 480 milligrams of Nevada, Mab doses that were equivalent to up to 15 milligrams per kilogram of unmatched if aluminum app.
This is remarkable in that a dose of three milligrams per kilogram of <unk>, let's not tolerable in combination with an equivalent dose of <unk> as shown in the 2013 Phase one study reported in the New England Journal.
Amy Peterson: Our partner, Bristol Monitors Squibb, is currently evaluating BMS 986249 plus nivolumab in a randomized phase 2 study against ipilimumab plus nivolumab in patients with untreated advanced melanoma. This novel combination is also being evaluated in advance for paticellular carcinoma, castration-resistant prostate cancer, and triple negative breast. In addition, BMS is conducting a Phase I study with BMS 986288, our probody of a non-fucosylated version of ipilimumab, again as monotherapy and in combination with nivolumab in patients with advanced solid tumors.
Our partner Bristol Myers Squibb is currently evaluating BMS 986 to 49, plus <unk> in a randomized phase III study against if aluminum <unk> plus <unk> in patients with untreated advanced melanoma. This novel combination is also being evaluated in advanced chip had a cellular carcinoma castration.
Distant prostate cancer and triple negative breast cancer.
In addition, BMS is conducting a phase one study with BMS 986 to 88, our pro body of a non fuel costs related version of ethylene the map again as monotherapy and in combination with Nevada and that in patients with advanced solid tumors.
Continuing with our work on potent immune modulator, the tremendous versatility of our platform is allowing us to expand the reach of probiotic therapeutics to T cell engaging bi specific antibodies or <unk>.
Amy Peterson: Continuing with our work on potent immune modulators, the tremendous versatility of our platform is allowing us to expand the reach of pro-body therapeutics to T cell engagement by specific antibodies, or TCB. Unmasked TCBs, even at very low concentrations, can engage normal tissue, even with low antigen expression of the target.
Unmask gcb's, even at very low concentrations can engage normal tissue, even with low antigen expression of the target.
Amy Peterson: This results in significant and sometimes quite harmful side effects and has limited the dose and applicability of this extremely potent anti-tumor immune mechanism, particularly for solid tumors. We believe our ProBody platform has the potential to meaningfully widen the therapeutic window for TCBs by localizing their therapeutic activity and target engagement to the tumor microenvironment. We have demonstrated this concept in non-clinical models and are now moving into the clinic in collaboration with Amgen with our first ProBody T-cell bispecific CX904.
This results in significant and sometimes quite harmful side effects and has limited the dose and applicability of this extremely potent antitumor immune mechanism, particularly for solid tumors.
We believe our probiotic platform has the potential to meaningfully widen the therapeutic window for TCP by localizing their therapeutic activity and target engagement to the tumor microenvironment.
We have demonstrated this concept in non clinical models and are now moving into the clinic in collaboration with Amgen with our first probiotic T cell bi specific CX 904.
Amy Peterson: CX904 is a conditionally-activated TCB targeting the Epidermal Growth Factor Receptor, or EGFR, and CD3, and is our most advanced program utilizing this modality. We submitted the IND in December of 2021, and, as noted by Sean earlier, we are in the process of initiating the first in-human Phase I study in patients with advanced solid tumors now, marking the sixth therapeutic candidate and the third treatment modality to enter the clinic from our ProBody platform.
CX 904, as a conditionally activated PCB targeting the epidermal growth factor receptor or Egfr and <unk> three and is our most advanced program utilizing this modality, we submitted the IND in December of 2021, and as noted by Shawn earlier, we are in the process of initiating the first in human Phase one study.
In patients with advanced solid tumors now, marking the sixth therapeutic candidate and the third treatment modality to enter the clinic from our pro body platform.
Another exciting and emerging application of this powerful and versatile platform is in the field of cytokines or interest in this area stems from the fact that systemic toxicity and poor exposure have limited the clinical success of this important and highly potent class of immune modulators.
Amy Peterson: Another exciting and emerging application of this powerful and versatile platform is in the field of cytokines. Our interest in this area stems from the fact that systemic toxicity and poor exposure have limited the clinical success of this important and highly potent class of immune modulators. By leveraging our deep understanding of the tumor microenvironment and our masking technologies, we have engineered a protease-activatable version of interferon-alpha-2b that incorporates both affinity-based peptide and steric masking technology.
By leveraging our deep understanding of the tumor microenvironment and our masking technologies, we have engineered a protease activate able version of interferon Alpha <unk> that incorporate both affinity based peptide and Derek masking technologies.
Amy Peterson: In preclinical studies, we have already seen that the dually masked interferon-alpha 2b provides an improved therapeutic window, and we are driving this program towards clinical candidate selection. From my comments today, I hope I have conveyed to you the breadth and depth of our platform and pipeline and the progress that we are making towards our commitment to destroying cancer. With that, I'll turn the call over to Chris for a financial review.
In preclinical studies, we have already seen that the duly mapped interferon Alpha <unk> provides an improved therapeutic window and we're driving this program towards clinical candidate selection.
From my comments today, I hope I have conveyed to you the breadth and depth of our platform and pipeline and the progress that we're making towards our commitment to destroying cancer differently.
With that I'll turn the call over to Chris for a financial review.
Amy Peterson: Thank you, Amy. Therapeutics entered 2022 with a strong balance. [Inaudible] As of December 31st, 2021, as Sean mentioned earlier, we had $305 million in cash, cash equivalents, and investment, which we project will fund the operations of the company well into 2023. For the fourth quarter of 2021, revenue was $20 million compared to $16 million for the corresponding period in 2020.
Thank you Amy.
<unk> entered 2022 with a strong balance sheet.
As of December 31, 2021, as Sean mentioned earlier, we had $305 million in cash cash equivalents and investments, which we project will fund the operations of the company well into 2023.
Chris Ogden: The increase was largely related to the CD71 collaboration with AbbVie. R&D expenses increased $15 million to $37 million during the three months ended December 31, 2021, compared to the corresponding period in 2020. The increase was driven by personnel expenses, clinical trial activities, and consulting and contract services to support our preclinical and clinical portfolios. G&A expenses were $9.5 million during the three months ended December 31, 2021, an increase of $300,000 compared to the same period in 2020, due mainly to increased personnel-related expenses.
For the fourth quarter of 2021 revenue was $20 million compared to $16 million for the corresponding period in 2020.
The increase was largely related to the CD 71 collaboration with Abbvie.
R&D expenses increased $15 million.
$237 million during the three months ended December 31, 2021 compared to the corresponding period in 2020.
The increase was driven by personnel expenses clinical trial activities and consulting and contract services to support our preclinical and clinical portfolio.
G&A expenses were $9 5 million during the three months ended December 31, 2021, an increase of $300000 compared to the same period in 2020 due.
Due mainly to increased personnel related expenses.
Before I hand, the call back to Sean for his closing remarks, I want to reiterate John's point earlier on prudent financial management at Photonics.
Chris Ogden: Before I hand the call back to Sean for his closing remarks, I want to reiterate Sean's point earlier on prudent financial management at CytomX. As we advance our pipeline to key inflection points. We will remain judicious with our capital and continue to marshal our cash resources thoughtfully. Sean, Thanks, Chris, and Amy. To wrap up, CytomX had a very strong 2021, and we have entered 2022 intensely focused on continued pipeline execution. Across multiple targets and within our broad and deep therapeutic pipeline, we have clearly demonstrated that conditional activation is a versatile approach to enhancing or indeed creating a therapeutic window for high-potential cancer treatments, and we see enormous opportunity for our technology.
As we advance our pipeline key inflection points, we will remain judicious with our capital and continue to Marshal our cash resources thoughtfully.
John .
Thanks, Chris and David.
To wrap up <unk> had a very strong 2021, and we have entered 2022 intensely focused on continued pipeline execution.
Across multiple targets and within our broad and deep therapeutic pipeline. We've clearly demonstrated the conditional activation is that first of all approach to enhancing or indeed, creating a therapeutic window for high potential treatments and we see enormous opportunity for our technology.
We have much more work to do to destroy cancer and our different approach leveraging our industry, leading priority platform offers unique opportunities to make a real impact.
Sean Mccarthy: We have much more work to do to destroy cancer, and our different approach, leveraging our industry-leading ProBody platform, offers unique opportunities to make a real impact. As our pipeline continues to grow and mature, we are working in increasingly defined areas of unmet medical need, as evidenced by the encouraging clinical activity of CX2029 in lung cancer and our ongoing Phase II studies of pralizatamab in breast cancer and of our anti-CTLA-4 probody in melanoma.
As our pipeline continues to grow and mature we are working increasingly defined areas of unmet medical need as evidenced by the encouraging clinical activity of <unk> nine in lung cancer, and our ongoing phase II studies of <unk> in breast cancer and of our anti <unk> in melanoma.
The substantial investments we have made in recent years and our platform and in our pipeline position us well to build long term value as we drive towards key milestones in 2022 for our most advanced programs. While also advancing many new product candidates towards the clinic.
Sean Mccarthy: The substantial investments we have made in recent years in our platform and in our pipeline position us well to build long-term value as we drive towards key milestones in 2022 for our most advanced programs, whilst also advancing many new product candidates towards the clinic. I want to extend my sincere thanks to the CytomX team for their ongoing dedication and commitment to our vision and mission.
I want to extend my sincere thanks to the <unk> team for their ongoing dedication and commitment to our vision and mission.
And in closing our thoughts are with everyone impacted by the unfolding events in Ukraine, and we hope for a peaceful solution to the crisis.
Operator: And in closing, our thoughts are with everyone impacted by the unfolding events in Ukraine, and we hope for a peaceful solution to the crisis. With that operator, we can now open the call up for Q&A. Thank you. If you have a question at this time, please press star then 1 on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key.
With that operator, we can now open the call up for Q&A.
Thank you if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key.
Gavin Scott: And our first question comes from the line of Gavin Scott with J.P. Morgan. Your line is open. Please go ahead. All right, thanks for the update, and thanks for taking our questions. Um, just a question on CX... 2009, and RMB in the TNVC breast cancer population. I'm just curious about the opportunity in the CD166 positive TNVC, and is there any stratification criteria in the protocol to see, I guess, pre-specified analysis across CD166 expression levels? Yeah, hey Gavin, thanks for the question. Let me kick that one off.
And our first question comes from the line of Gavin Scott with Jpmorgan. Your line is open. Please go ahead.
Alright, Thanks, Sheila and thanks for taking my questions.
A question on Gx.
<unk> nine and RMB and the key CNBC.
Breast cancer population I'm just curious.
The opportunity in the CD 166 positive CNBC.
Are there any stratification criteria in the protocol.
See I guess pre specified analysis across GB and 166 expression levels.
Yeah.
Yeah, Hey, Kevin Thanks for the question, let me kick that one off.
Sean Mccarthy: So, as Amy mentioned a few moments ago, across arms A and B, with arm A, what we observed in phase one and in the public databases is high expression of CD166 in the majority of patients. So, in arm A, we're not selecting for target selection is not a criterion for enrollment. In contrast to arm B, where in our phase one experience, and also looking at the data through the public databases, you can see that CD166 is more heterogeneous, and so we are utilizing a patient selection strategy for arm B.
<unk>.
And you mentioned a few moments ago across arms AMB.
With arm.
What we observed in phase one.
And in the public databases as high expression of <unk> 66 in the majority of patients.
So in RMA were not selecting for target selection is not a criteria for enrollment.
In contrast, the RMB were in our phase one experience and also looking at the data through the public databases.
You can see the CD 166 is more heterogeneous and so we are utilizing our patient selection strategy for RMB.
Sean Mccarthy: We do require, in both arms A and B, CD166 high for the definition of efficacy of valuable. That's something that we're not discussing in a lot of detail right now in terms of where that cutoff is going to be. We need to learn more about the target in triple negative breast cancer, in particular, and given, as you know, that it's a diagnosis of exclusion with a fairly heterogeneous histological definition. So, more to come on that as we go through the year. Great, thank you. Thank you. And our next question comes from the line of Kovari Pullman with BTIG. Your line is open.
We do require in both arms, a and b.
<unk> <unk> hundred 66 high four.
The definition of efficacy evaluable.
That we're not discussing it a lot of detail right now in terms of where that cut off is going to be.
We need to learn more about the target in triple negative in particular.
Given the given as you know that it's a diagnosis of exclusion exclusion with a fairly heterogeneous histological definition. So so more to come on that as we go through the year.
Great. Thank you.
Thank you and our next question comes from the line of Paul <unk> with <unk>. Your line is open. Please go ahead.
Kovari Pullman: Please go ahead. Yeah, good afternoon, and thanks for the update. For the TNVC study again, are you enrolling patients who are TRDEL-V experienced, and will we see any data for that? Yeah, Kaveri, thanks for the question. So, if I could just repeat it.
Yes, good afternoon, and thanks for the update of bulky NBC, Bobby again are you enrolling patients globally.
And will we see any data for that.
Yeah, great. Thanks for the question, so if I could just repeat it.
So the question is OE enrolling patients who are experienced on <unk>.
Sean Mccarthy: So the question is, are we enrolling patients who are experienced with Tredelvi? And the short answer is yes, we do expect to see some patients for sure who have experienced Tredelvi. I want to remind everyone that in our previously reported clinical study, we did see a very intriguing response in a patient who had progressed on Tredelvi to sasitizumab, so we have evidence that pradasasumab can work in that patient population. We are enrolling in the U.S. and ex-U.S. And so we would expect, given the approval in the U.S. and the pending approvals in the ex-U.S., that we would end up with a somewhat mixed patient population, some of whom have been, and some of whom have not been treated with Tredelvi.
<unk> and the short answer is yes, we do expect to see us.
Some patients for sure having experience to Adobe.
I want to.
Remind everyone that in our previously reported clinical study we did see a very intriguing response in a patient who had progressed entre Dolby on constitutes a map.
So we have evidenced that.
Is that something uptime work in that patient population.
We are enrolling in.
The U S and ex U S.
So we would expect given the.
Approval in the U S and the pending approvals ex U S that we would end up with a somewhat mixed patient population some of whom have and some of whom have not been treated with fidelity.
Got it thats useful and regarding that Egfr <unk> <unk> bispecific.
Sean Mccarthy: And regarding the EGFR-CD3 bi-specific, the CRIPNO meeting poster shows a 2 plus 2 design for this molecule. Can you talk about your rationale for using this format because I believe that format is mostly used for better safety, but 904 is already masked to provide tumor-directed activity. Yeah, good question.
Our meeting poster shows a two plus two design for this molecule can you talk about your rationale for using two bloodstream format. Because I believe that format is what we use for better safety, but lineup was already to provide <unk> with activity.
Yes, good question.
Sean Mccarthy: And thanks for pointing out some of our previously published work on the program. So just to be clear, the 2 plus 2 you're referring to is the dual antigen for both CD3, two CD3s, and two EGFRs, I believe, correct? Correct. Yeah, so we haven't disclosed the actual molecular anatomy of 904 at this point. We have done a considerable amount of additional optimization of that program to ultimately reach 904 as the clinical candidate in collaboration with our partner Amgen. And so the structure of 904 is not yet disclosed.
And thanks for pointing out some of our previously published work.
On the program.
So just just to just to be clear the two plus two youre, referring to is the dual antigen for both CD three <unk> and two Egfr is I believe correct.
Correct.
Yes, so we haven't disclosed the actual.
Molecular anatomy of minus four to this point, we have done considerable amount of additional optimization of that program to ultimately reach 904 as the clinical candidate in collaboration with our partner Amgen and so actually the structure of minus four is not yet.
Disclosed.
Got it thank you.
Sean Mccarthy: Got it. Thank you. And thanks for taking my questions. You're welcome. Thank you. And our next question comes from the line of Joe Cannizzaro with Piper Sandler. Your line is open.
Thanks for taking my questions.
Youre welcome.
Thank you and our next question comes from the line of Joe Kim Massaro with Piper Sandler. Your line is open. Please go ahead.
Joe Cannizzaro: Please go ahead. Hey, thanks for taking my questions. Maybe the first one for me.
Joe Cannizzaro: I think for CX-20029's initial phase two readout ahead of that, you characterize the size of the data set that's going to show meaningful progress towards the planned 25 patients per cohort in that study. So maybe with that, at this point, I guess, how would you characterize expectations for sample size for 2009's initial phase two monitor, be read out, thanks, and I have a poll. Yeah. Hi, Joe.
Hey, Thanks for taking my questions maybe the first one from me I think for CX, 2029th initial phase II readout ahead of that.
Characterize the size of the dataset.
<unk> gone to show meaningful progress towards the planned 25 patients per cohort in that study.
So maybe with that at this point I guess, how would you characterize expectations for sample size for 2000 Nine's initial phase II monotherapy readout. Thanks.
A follow up.
Yes, Hi, Joe Thanks for the question.
Sean Mccarthy: Thanks for the question. So to recap the goals of the Phase 2, the three-arm study, the goal is to enroll 40, 4-0, efficacy-evaluable patients in each arm. And we are making very good progress with enrollment. As you may recall, we had a few bumps in the road last year, but the team did an amazing job.
So.
Just to recap the goal goals.
The phase III.
The three arm study the goal is to enroll 44 zero efficacy evaluable patients in each arm and we are making very good progress with enrollment.
As you May recall, we had a few bumps in the road last year, but the team has done an amazing job.
Sean Mccarthy: And we are making progress. Our guidance at this point is data from arms A and B, initial data this year. We do expect them to be meaningful numbers of patients, but we're not quite ready to comment on a specific number at this point. Okay, I got it. And if I could just ask a follow-up question. I was scanning through the 2009 publication, and I noticed a figure that showed a strong correlation between unmasked antibody in the tumor and expression of CD166, and I'm trying to understand what the cause-effect relationship there is.
We are making progress.
<unk>.
Our guidance at this point is.
Data from arms AMB initial data this year, we do expect it to be meaningful numbers of patients, we're not quite ready to comment on a specific number at this point.
Okay got it and then if I could just ask a follow up I was scanning through the 2009 publication and then noticed the figure that showed a strong correlation between unmask the antibody in the tumor <unk> expression, CD 166, and I'm trying to understand what the cause effect relationship. There is if you could help with that.
That'd be great.
Yes, it's a great question and thanks.
Sean Mccarthy: If you could help with that, that'd be great. Yeah, it's a great question. And thanks for studying the publication in detail. There's a lot in there that we wanted to report. You know, I don't want to get into too many details here, but I mean, there's a lot still to learn about the... The sequence of events with regard to pro-body, ProBody functionality, and one can imagine this derives from a relationship between activation and target levels and the order in which the ProBody actually becomes converted into the active form.
Studying the studying the publication in detail there is a lot in there that.
We wanted to report.
I don't want to get too many details here, but I mean, there's there's a lot still to learn about the.
The sequence of events with regard to pro body.
Pro body functionality.
And.
One can imagine this derives from.
Relationship between.
Activation and target level in the order in which the provost actually becomes converted into the active form so.
Sean Mccarthy: So it's an intriguing observation. There's a little bit written in the paper about that, but we think it provides some interesting translational insight into how this platform functions. Okay, got it. Thanks. Thanks for taking my question. You're welcome.
It's an intriguing observation there is a little bit in the paper about that.
So we think it provides some interesting translational insight into how this platform functions.
Okay got it thanks, Thanks for taking my questions.
Youre welcome.
Thank you and our next question comes from the line of Mara Goldstein with Mizuho. Your line is open. Please go ahead.
Mara Goldstein: Thank you. And our next question comes from the line of Mara Goldstein with Mizuho. Your line is open.
Mara Goldstein: Please go ahead. Hi, thank you for taking my question. This is the support from Margo Steen.
Hi, Thank you for taking my question does this support from Mara Goldstein.
Mara Goldstein: My question is on CF 2009, which, so the data is now expecting the second half of 2022, even though it was previously guided in for 2022. Is it fair to characterize that as a slight delay and wondering if we can provide a little bit of color about that? Yeah, that'd be good. Well, good question. I would not characterize it as a delay.
My question was on CX 2009.
Further data grow now expecting.
The second half of 2022, even though it was previously guided.
In 2022.
Is it fair to characterize that as a slight delay and just wondering if you can provide.
Sorry about that.
That would be good.
Good question.
I would not characterize it as a delay I think the.
It's obviously a refinement.
Sean Mccarthy: I think that the It's obviously a refinement of our guidance, which we wanted to give today. We are given that this is a fairly substantial phase two study. We are working towards giving meaningful updates and so giving ourselves a little bit more time to get data that will provide us with pointers to the next steps in the product. Be able to share that with external stakeholders, we think it is the right thing to do. So we don't want to, and we see no need to communicate data that is too premature.
Our guidance, which.
We wanted to give today.
We are.
Given this is a.
A fairly substantial phase II study.
We are working towards giving meaningful updates and so giving ourselves a little bit more time to get data that will.
Provide us.
With points us to the next steps in the product development and also.
Be able to share that with external stakeholders. We think is the right thing to do so we don't want to.
We see no need to communicate.
Data that is too premature.
Got it.
Sean Mccarthy: Got it. Thank you. Thank you. And our next question comes from the line of Roger Song with Jeffreys. Your line is open.
<unk>.
Thank you and our next question comes from the line of Roger song with Jefferies. Your line is open. Please go ahead.
Roger Song: Please go ahead. Great. Thank you for taking our question. Just quickly, to confirm some of the logistics, for 2029, you're expecting the men's malarial lung cancer update in the second half. Any comments around the other cohorts, like the GEJ and the DLPCL data readout? Similarly, for the 904, any comment around the data timing will be helpful. Thank you. Yeah. Hi Roger.
Great.
Thank you for taking our question just a quickly to confirm some of the logistic.
Two nine.
We're expecting that non small cell lung cancer at the second half.
Any comments around <unk>.
Cohort like Joe on multi LPL data readout similarly for the.
Now for <unk>.
Hello, Ron that data timing would be helpful. Thank you.
Yeah, Hi, Roger Thanks for the questions.
Sean Mccarthy: Thanks for the questions. So yeah, regarding 2029 second half, as you can see, we've got a significant amount of data that the team is working towards disclosing in the second half of this year, so it's going to be an important time for the pipeline for the company. We're not ready yet to say really anything else about the additional cohorts in 2029. The pipeline continues in the esophageal and gastroesophage
So, yes, so regarding <unk> second half <unk>.
Can see we've got a significant amount of data the team is working towards.
Disclosing in second half of this year, so it's going to be an important time for the pipeline for the company.
We're not ready yet to say anything else about the additional cohorts until it's United enrollment continues in.
Our softgel and gastroesophageal junction.
Sean Mccarthy: As you know, DLBCL is also included in that expansion phase, so we'll provide additional commentary as the year goes on. With regard to 904, just getting that up and running, the team did a great job getting the IND cleared. I would not expect any data from 904 this year.
As you know <unk> is also included in that expansion phase.
So we will provide additional commentary as the year as the year goes on with regards to 904.
Just getting that up and running.
The team did a great job getting the IND cleared.
And.
I would not expect any data from 904 this year, we need to get into dose escalation.
Sean Mccarthy: We need to get into those escalation stages, get going. And as you know, with agents like this, T cell engaging by specifics, starting doses tend to be on the low side. So we're going to give ourselves some time there as well. So not ready to guide on data for 904 at this stage. Got it.
Get going and.
As you know.
With agents like this T cell engaging by specifics.
Starting doses tend to be on the low side. So we're going to give ourselves some time, there as well so.
Not ready to guide on data from 904 at this stage.
Got it thank you.
Youre welcome.
Thank you and our next question comes from the line of Mitchell Kapoor with H C. Wainwright. Your line is open. Please go ahead.
Sean Mccarthy: Thank you. Thank you. And our next question comes from the line of Mitchell Kapoor with HC Wainwright. Your line is open.
Mitchell Kapoor: Please go ahead. Hey there, thanks for taking the questions. The first one, I just wanted to ask on arm C of the phase 2 of pralizatumab, you know, what kind of added benefit we could expect from pacmilamab to show in TNBC, and how should we think about it being positive when we compare it to separation from monotherapy? Yeah, thanks for the question, Mitch. Let me hand that one over to Amy. Hi Mitch.
Hey, there thanks for taking the questions. The first one I just wanted to ask on arm C of the phase III trial is that a map.
What kind of what kind of added benefit could we expect from Pac Miller map to show and CNBC and how should we think about it being positive when we compare to separation for monotherapy.
Yes. Thanks for the question Mitch, Let me hand that one over to Amy.
Amy Peterson: Thanks for the question. Um, one thing that I want to state is that we have demonstrated monotherapy activity with each of these agents in triple negative breast cancer. So we reported on monotherapy activity with Pacmilimab in phase one expansion in triple negative breast cancer, not only triple negative breast cancer, but a very difficult subset of triple negative breast cancer to treat, which is inflammatory breast cancer. So we observed activity.
Hi, Mitch Thanks for the question.
One thing that I want to state is we have demonstrated monotherapy activity with each of these agents in triple negative breast cancer. So we've reported on monotherapy activity with <unk> in the phase one expansion in triple negative breast cancer, not only triple negative breast cancer that are very difficult.
Subset of triple negative breast cancer to treat which is inflammatory breast cancer. So we observed activity.
Amy Peterson: We also observed activity in triple negative breast cancer in 2009. When it comes to what you might see from the combination, that is not, it's not yet clear what we need to see. We know that Checkpoint Inhibition works in combination with chemotherapy, Pembrolizumab being approved and maintaining its approval in frontline triple negative breast cancer, and so we know what we think it might need to look like, but we aren't necessarily able to say anything more specific about what we're hoping to.
We also observed activity in triple negative breast cancer with <unk> when it comes to what you might see from the combination that is not.
It is not yet clear what what we need to see.
We know that.
Checkpoint inhibition works in combination with chemotherapy <unk> being approved and maintaining its approval in frontline triple negative breast cancer.
And so we know what we think it might need to look like but we aren't necessarily able to say anything more specific about what were what were.
Hoping to see.
Amy Peterson: I think if we think about response rates with sasituzumab as monotherapy in this setting in the mid-30s, we would want to see something that is compelling in a patient population that is possibly refractory to sasituzumab. Great, thank you very much. And then just thinking about any potential milestones we could see this year.
I think we think about response rates with SASSA to the Mab as monotherapy in this setting in the mid <unk>.
We would want to see something that is compelling in a patient population that is possibly refractory this attitude of map.
Great. Thank you very much and then.
Just thinking about any potential milestones we could see this year could you talk about any of those that we could see from collaborators.
Yeah. Thanks for the question.
Sean Mccarthy: Could you talk about any of those that we could see from the collaborators? Yeah, thanks, Mitch, for the question. We haven't disclosed any additional milestone structures in our alliances at this point. As I mentioned in my remarks early on in my comments today, our cash runway projection of well into 2023 does not take into account any milestones or any new BD activity. And we have, as I said, consistently been able to finance the company through a mix of dilutive and non-dilutive capital.
We're not we haven't disclosed any additional milestone structures in our in our alliances at this point as I mentioned on.
And my my remarks early on in my.
My comments today.
Our.
Cash runway projection of well into 2023 does not take into account any milestones or any new BD activity.
And we have.
Yes.
As I said consistently been able to finance the company through a mix of dilutive in alternative capital and we expect that to continue to be the case.
Great. Thank you very much.
Sean Mccarthy: And we expect that to continue to be the case. Great. Thank you very much. You're welcome. Thank you. Thank you. And our next question comes from the line of Peter Lawson with Barclays. Your line is open.
Youre welcome. Thank you.
Peter Lawson: Please go ahead. Hey, thanks for taking the questions. Just as regards the updates, thanks for the timing around updates in the second half. Anything you can say around the number of patients or time on therapy for the triple negative and, HR Positive, HER2 Negative. Hi Peter, this is Amy. Thanks for the question. So for Arm A, which is hormone receptor positive breast cancer, one of the key secondary endpoints is going to be CBR 24, which is CRPR stable disease through 24 weeks. And obviously, that takes six months to get if you're going to get to 24 weeks.
Thank you and our next question comes from the line of Peter Lawson with Barclays. Your line is open. Please go ahead.
Hey, thanks for taking the questions.
Just as regards to the update thanks for that timing around updates in the second half.
You can say around kind of the number of patients so.
Time on therapy for the Triple negative.
HR positive <unk> negative.
Yes.
Hi, Peter This is Amy thanks for the question so for RMA, which is hormone receptor positive breast cancer. One of the key secondary endpoint is going to be CVR 24, which is stable.
<unk> stable diseases through 24 weeks.
And obviously that takes six months to get if youre going to get to 24 weeks. So there is a time component to this.
Amy Peterson: So there is a time component to this, and response rates are not necessarily the strongest indicator of activity in this particular disease. We'll see what the details of the data are with DRX-Tcan, and of course, we're interested to see what happens with statsituzumab in this setting with regard to response rates. But we're really focusing on CBR24 and then, of course, PFS because if you think about what might be the next study, it's going to be depending on what the data show us, and if they hint in a way that favors activity with this, it would be a randomized study where PFS might be the endpoint.
Response rates are not necessarily the strongest indicator of activity in this particular disease, we will see what.
The details of the data are with <unk> and of course, we're interested to see what happens with Dacetuzumab in this setting with regard to response rate, but we're really focusing on CBR 24, and then of course PFS because if you think about what might be the next study it's going to be depending on what the data show a lesson if there <unk>.
<unk> in a way that favors activity with us it would be a randomized study where PFS might be the end point. So we will be looking at as those end points very carefully and army.
Amy Peterson: So we'll be looking at those endpoints very carefully in RMA and for R&B, and there we're talking about a patient population of approximately 40, 4-0 efficacy in valuable patients. A population that we can look at, that we can get our heads around, and that we can begin to define the point estimates for the pivotal study.
For RMB.
And there we're talking about patient population of approximately 44 zero efficacy evaluable patients. So.
A population that we can look at that we can get our heads around and that we can begin to define the point estimates for the pivotal study that's what we're talking about when we say a meaningful patient sample size the.
Amy Peterson: That's what we're talking about when we say a meaningful patient sample size. The same thing for triple negative breast cancer. Here, of course, response rates can be the basis for accelerated approval. However, as you already know, we need durability of those responses. You can't just get the first confirmation and report the response rate.
At the same thing for Triple negative breast cancer here of course response rate can be the basis for accelerated approval. However, as you already know we need durability of those responses you can't just get.
The first confirmation and report the response rates durability.
<unk> response rate durability of response are going to be the two key endpoints that we're focusing on in that patient population and again, a meaningful patient population and what do I mean by meaningful something where if we look at it we would know how to take this molecule into the next study with the next study.
Amy Peterson: Response rates and durability of response are going to be the two key endpoints that we're focusing on in that patient population. Again, a meaningful patient population, and what do I mean by meaningful? Something where, if we looked at it, we would know how to take this molecule into the next study, with the next study having an eye towards registration.
Having an eye towards registration.
Got you. Thank you.
Amy Peterson: Gotcha. Thank you. Same question really for 2029 in non-small cell lung cancer, kind of how much of an update we're going to get? Is that kind of durability plus additional patients? So I think, yeah, the same principles applied here. Peter, of course, the population is slightly smaller.
Same question really for 2029.
Non small cell lung cancer kind of how much of an update we're going to get is that the kind of <unk>.
<unk> ability plus additional patients.
Amy Peterson: It's 25 efficacy of valuable patients, but again, it's efficacy of valuable patients who had at least one post-baseline assessment. And there, again, we're looking at response rates and durability of the response to PFAS. Those are all the things that will help inform whether this molecule goes forward and how it goes forward. Confidence intervals might be a little bit wider, but we should have some understanding. Thank you. And then just a final question on 904, I think, so the details around data next year, et cetera.
So I think you have the same principles apply here Peter of course, the population and slightly smaller 25 efficacy evaluable, but again its efficacy evaluable patients who had at least one post baseline assessment.
And there again, we're looking at response rates and durability of the response.
PFS those are all the things that will help inform whether this molecule goes forward and how it goes forward its a slightly smaller sample size confidence intervals might be a little bit wider but we should have.
Some understanding.
Got you. Thank you and then just a final question on <unk>.
Thanks.
Details around data next year et cetera.
But.
Amy Peterson: But what indications should we be thinking about? Is that going to be predominantly non-small cell lung cancer? So... Too early to comment on any specific indication, I would just observe that EGFR is a widely expressed tumor antigen with a lot of uncertainty. Unharnessed potential, I would say, across many different tumor types.
What indications should we be thinking about is that predominantly non small cell lung cancer.
So.
Too early to comment.
Any specific indication I would just observe that.
<unk> is a widely expressed tumor antigen.
A lot of fun.
On harnessed potential I would say across many different tumor types. So we're excited about this product candidate.
Sean Mccarthy: So, you know, we're excited about this product candidate. And as we mentioned, the phase one design is a dose escalation in solid tumors initially. And together with our partner Amgen, one could envisage some further focusing of that study over time into specific tumor types, obviously, that express EGFR, of which there are many.
As we mentioned the phase one design is a dose escalation in solid tumors initially.
And.
Together with our partner Amgen, one could envisage some further focusing at that study over time into specific tumor types.
We see that express egfr of which there are many.
Perfect. Okay. Thank you so much.
Sean Mccarthy: Perfect. Okay. Thank you so much. You're welcome. At this time, I would like to hand the call back over to Chow Chin for his closing remarks. Finally, on behalf of the Executive Team, I would like to thank you all very much for joining us this afternoon. We look forward to updating you in the future on our ongoing progress. This does conclude today's conference call. Thank you all for participating. You may now disconnect. Have a great day! [music]
Youre welcome.
At this time I would like to hand, the call back over to Chad for his closing remarks.
On behalf of the executive team I would like to thank you all very much for joining us. This afternoon, we look forward to updating you in the future on our ongoing progress.
This does conclude today's conference call. Thank you all for participating you may now disconnect have a great day.
Hello, everyone.
[music].