Q2 2024 Cardiff Oncology Inc Earnings Call
Fairooz Kabbinavar, Joseph Catanzaro, Laurence Watts, James Levine, Mark Erlander, Fairooz Kabbinavar, Kiki Patel, Cardiff Oncology Fairooz Kabbinavar, Joseph Catanzaro, Laurence Watts, James Levine, Mark Erlander, Fairooz Kabbinavar, Joseph Catanzaro, Laurence Watts, James Levine, Mark Erlander, Fairooz
Kiki Patel: Marc Frahm, Joseph Catanzaro, Laurence Watts, James Levine Marc Frahm, Joseph Catanzaro, Laurence Watts, James Levine, Mark Erlander, Fairooz Kabbinavar, I would now like to turn the conference call over to Kiki Patel of Gail Martin Group. Please go ahead. Thank you, operator.
Operator: Welcome to the Cardiff Oncology Second Quarter 2024 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone, and you will then hear an automated message advising that your hand is raised. Please be advised that today's conference is being recorded. I would now like to turn the conference call over to Kiki Patel of the Scale Martin Group. Please go ahead.
Speaker Change: Welcome to the Cardiff Oncology 2nd Quarter 2024 Financial Results and Business Update Conference Call.
Speaker Change: At this time, all participants are in a listen-only mode.
Speaker Change: After the speaker's presentation, there will be a question and answer session.
Speaker Change: To ask a question during the session, you will need to press star 1 on your telephone and you will then hear an automated message advising your hand is raised.
Speaker Change: Please be advised that today's conference is being recorded. I would now like to turn the conference call over to Kiki Patel of Gail Martin Group. Please go ahead.
Kiki Patel: Joining us on the call today from Cardiff Oncology are Chief Executive Officer Mark Erlander and Chief Financial Officer Jamie Levine. During this conference call, management will make forward-looking statements, including, without limitation, statements related to guidance, results, and the timing of data readouts for advanced or tripped clinical trials. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties.
Kiki Patel: Thank you, Operator. Joining us on the call today from Cardiff Oncology are Chief Executive Officer Mark Erlander and Chief Financial Officer Jamie Levine.
Mark Erlander: Joining us on the call today from Cardiff Oncology are Chief Executive Officer, Mark Erlander, and Chief Financial Officer, Jamie Levine. During this conference call, management will make four Muslim statements, including without limitations, statements related to guidance, results, and the timing of data readouts for our advanced literature clinical trials. These four-word-looking statements are based on the company's current expectations and inherently involved significant risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated and such four-word-looking statements as a result of these risks and uncertainties.
Speaker Change: During this conference call, management will make forward-looking statements, including, without limitation, statements related to guidance, results, and the timing of data readouts for advanced literature clinical trials.
Speaker Change: These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties.
Speaker Change: Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties.
Speaker Change: Factors that could cause results to be different from these statements include factors that got me described in the section titled risk factors in its annual report on Form 10-K filed with the SEC for the year ended December 31st 2023.
Mark Erlander: Factors that could cause the results to be different from these statements include factors that the company describes in the section titled RISFactors in its annual report on form 10K, filed with the FEC for the year ended December 31, 2023.
Cardiff oncology: Cardiff Oncology undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations.
Mark Erlander: Cardiff Oncology undertakes no duty or obligations to update any four-looking statements as a result of you information, future events, or changes in its expectations.
Kiki Patel: Factors that could cause those results to be different from these statements include factors that can be described in the section titled Risk Factors, if the annual report on form 10K filed with the FEC for the year ended December 31, 2020. Cardiff Oncology undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations. With that, I turn the call over to Chief Executive Officer Mark Erlander. Marc? Thanks.
Speaker Change: With that, I turn the call over to Chief Executive Officer Mark Erlander. Mark?
Mark Erlander: Thank you, Kiki, and good afternoon everyone, and thank you for joining our Business Update Conference Call for the second quarter of 2024. These are certainly energizing times at Cardiff Oncology as we activate sites and enroll patients in our Cardiff-004 trial in RAS-mutated metastatic colorectal cancer, or MCRC. The interactions we're having with the physicians and other professionals at the trial sites reinforce our own excitement at the potential to bring a more effective therapy to this large patient population of nearly 50,000 new patients a year in the U.S. alone.
Mark Erlander: With that, I turn the call over to Chief Executive Officer, Mark Erlander. Mark? Thank you, Kiki, and good afternoon, everyone, and thank you for joining our Business Update Conference call for the second quarter of 2024.
Mark Erlander: Thank you, Kiki, and good afternoon, everyone, and thank you for joining our Business Update Conference call for the second quarter of 2024.
Mark Erlander: These are certainly energizing times at Cardiff Oncology as we activate sites and enroll patients in our Cardiff-004 trial in RAS-mutated metastatic colorectal cancer, or MCRC.
Mark Erlander: These are certainly energized in times that Cardiff Oncology, as we activate sites and role-patients in our Cardiff 004 trial in RASF-Utated, Medesthetical Retrocancer for MCRC. The interactions we're having with the positions and other professionals at the trial sites reinforce our own excite at the potential to bring a more effective therapy to this large patient population of nearly 50,000 new patients a year in the US alone. Specifically, the totality of the data, the more phased on V2s and ensemble second-line MCRC trials, demonstrates on banquets it has the potential to shift the treatment paradigm for all rat-mutated MCRC, not just subgroups of payrolls.
Mark Erlander: The interactions we're having with the physicians and other professionals at the trial sites reinforce our own excitement at the potential to bring a more effective therapy to this large patient population of nearly 50,000 new patients a year in the US alone.
Mark Erlander: Specifically, the totality of the data, the Marfazone V2 and Ensembl second-line MCRC trials, shows that vancirtube has the potential to shift the treatment paradigm for all RAS-mutated MCRCs, not just subgroups of payroll. We say this because, first, there have been no new therapies approved for these patients over the past 20 years. Second, there are no competing clinical trials for this patient population. And third, unlike prior POK1 inhibitors, Onvancerdip is well-tolerated when combined with chemotherapy, which also opens the door to other chemo combinations for additional cancer indications. So let's dive in.
Mark Erlander: Specifically, the totality of the data from our Phaedron V2 and Ensembl second-line MCRC trials demonstrates Oncobacter tube has the potential to shift the treatment paradigm for all RAS-mutated MCRC, not just subgroups of payrolls.
Mark Erlander: We say this because first, there have been no new therapies approved for these patients over the past 20 years.
Mark Erlander: We say that because first, there has been no new therapies approved for these patients over the past 20 years. Second, there are no competing clinical trials for this patient's population. And third, unlike prior field-k-1 inhibitors, on banquets it is well tolerated when combined with chemotherapy, which also opens the door to other penal combinations for additional cancer indications.
Mark Erlander: Second, there are no competing clinical trials for this patient population.
Mark Erlander: And third, unlike prior POK1 inhibitors, Onvancerdib is well-tolerated when combined with chemotherapy, which also opens the door to other chemo combinations for additional cancer indications.
Mark Erlander: On today's call, we will cover four topics. First, I will discuss our lead program and MTRC and provide updates on our ongoing Cardiff Zero Zero full trial. Second, I will provide an update on our pancreatic cancer program. Third, I will provide a brief overview of our continued encouraging preclinical data demonstrating vascular tube activity and other cancer indications with unmet clinical need beyond graft-mutated MCRs. And finally, we will talk about our financial position that we disclosed today in our forum 10-Q. So let's begin.
Speaker Change: So let's dive in. On today's call, we will cover four topics. First, I will discuss our lead program in the MCRC and provide updates around our ongoing Cardiff-004 trial.
Mark Erlander: So let's dive in. On today's call, we will cover four topics. First, I will discuss our lead program, an MCRC, and provide updates around our ongoing Cardiff 004 trial. Second, I will provide an update on our pancreatic cancer program. Third, I will provide a brief overview of our continued, encouraging pre-clinical data demonstrating on banquets activity in other cancer indications with on that clinical need beyond rat-mutated MCRC. And finally, we will talk about our financial position that we disclosed today in our form 10Q.
Mark Erlander: Second, I will provide an update on our pancreatic cancer program.
Mark Erlander: Third, I will provide a brief overview of our continued encouraging preclinical data demonstrating on VASTA-2's activity and other cancer indications with unmet clinical need beyond RAS-mutated MCRC.
Mark Erlander: And finally, we will talk about our financial position that we disclosed today in our Form 10-Q .
Mark Erlander: This quarter, we have been intensely focused on the clinical execution of our Cardiff-004 trial, evaluating the contribution of Onvanstertib in first-line RAS-mutated MCRC. As a reminder, CARDF-004 is our ongoing Phase II trial evaluating vancitibs in combination with current standard care, which consists of either full fairy foot bed or full fox foot. The trial is currently active in 33 sites, and we plan to enroll 90 patients who will be randomized to receive either a 20 mg or a 30 mg dose of Advancetib plus standard of care or standard of care alone.
Mark Erlander: So let's begin.
Mark Erlander: This quarter, we have been intensely focused on the clinical execution of our Cardiff-004 trial, evaluating the contribution of Onvanstertib in first-line RAS-mutated MCRC.
Mark Erlander: So let's begin. This quarter, we have been intensely focused on the clinical execution of our Cardiff 004 trial, evaluating the contribution of on banquets in first line rat-mutated MCRC. As a reminder, Cardiff 004 is our ongoing Phase II trial, evaluating on banquets in combination with current standard care, which consists of either full theory plus bed or full box plus bed. The trial is currently active in 33 sites and we plan to enroll 90 patients who will be randomized to receive either a 20 milligram or a 30 milligram dose of unsanitary plus standard care or standard care alone.
Mark Erlander: As a reminder, Cardiff-004 is our ongoing Phase 2 trial, evaluating on density, in combination with current standard care, which consists of either Full Theory Plus Bev or Full Fox Plus Bev.
Mark Erlander: The trial is currently active in 33 sites, and we plan to enroll 90 patients, who will be randomized to receive either a 20 mg or a 30 mg dose of Advancetib plus standard of care or standard of care alone.
Mark Erlander: Our team at Cardiff Oncology, alongside our clinical execution partner, Pfizer Ignite, is diligently working on the enrollment of the trial. We continue to leverage Pfizer's resources and capabilities in multiple areas to drive enrollment. We also appreciate the commitment and the clinical efforts of our enthusiastic investigators who have been judiciously screening patients across our active sites. Based on the current pace of enrollment over the past few months, we continue to plan on releasing an initial data readout later this year, as we previously planned.
Mark Erlander: Our team that caught up on ecology alongside our clinical execution partner Pfizer tonight is diligently working on the enrollment of the trial. We continue to leverage Pfizer's resources and capabilities in multiple areas to drive enrollment.
Mark Erlander: Our team that Cardiff oncology alongside our clinical execution partner Pfizer night is diligently working on the enrollment of the trial. We continue to leverage Pfizer's resources and capabilities in multiple areas to drive enrollment. We also appreciate the commitment and the clinical efforts of our enthusiastic investigators who have been judiciously screening patients across our active sites. Based on the current pace of enrollment over the past few months, we continue to plan on releasing an initial data readout later this year as we previously guided. We expect this will include objective response rate data for approximately half of the patients who plan to enroll in the trial.
Mark Erlander: We also appreciate the commitment and the clinical efforts of our enthusiastic investigators who have been judiciously screening patients across our active sites.
Mark Erlander: Based on the current pace of enrollment over the past few months, we continue to plan on releasing an initial data readout later this year as we previously guided. We expect this will include objective response rate data for approximately half of the patients we plan to enroll in the trial.
Mark Erlander: We expect this will include objective response rate data for approximately half of the patients we plan to enroll in the trial. Now I'd like to turn to our second agenda item, and an update on our pink Vedic cancer program, focused on metastatic pink Vedic ductal edinal carcinoma, or PDAX. In September of last year, we released data from our Phase 2 trial for metastatic PDAC in the second line. In this single-arm trial, patients received Onvancer in combination with the chemotherapy regimen of liposomal, areta secan, leucoborin, and 5-FU.
Speaker Change: Kiki Patel, Mark Erlander, James Levine, Laurence Watts, Fairooz Kabbinavar
Speaker Change: Now, I'd like to turn to our second agenda item, an update on our pancreatic cancer program focused on metastatic pancreatic ductal adenocarcinoma, or PDAC. In September of last year, we released data from our Phase 2 trial for metastatic PDAC in the second line setting.
Mark Erlander: Now I'd like to turn to our second agenda item and update on our pink vatic cancer program focused on metastatic, pancreatic, ductile edinocarcinoma, or PDAC. In September of last year, we released data from our Phase II trial for metastatic feedback in the second one. In this single arm trial, patients who see on-dancers in combination with the chemotherapy regimen of liposomal, aridity can, luka borin, and bideapute. After discussing the results with our investigators, we decided the next step of our PDAC program would be an investigator-initiative trial in the first line study combining on-dancers with standard care jam abraxing.
Speaker Change: In this single-arm trial, patients received Onvancer in combination with the chemotherapy regimens of liposomal, areta secan, leucoborin, and 5-FU.
Mark Erlander: After discussing the results with our investigators, we decided the next step of our PDAC program would be an investigator-initiated trial in the first-line study, combining on-bancher tibs with generative care, Jim Abraxas. Today, we are sharing an update on our plans for metastatic PEDEC because earlier this year, Malarie Fox was approved for first-line metastatic PEDEC after the NAPOLE 3 trial showed significantly greater improvement in overall survival and progression-free survival with first-line Malarie Fox compared to Jamma Braxen.
Speaker Change: After discussing the results with our investigators, we decided the next step of our PDAC program would be an investigator-initiated trial in the first-line setting, combining on bancer tibs with standard of care gem abraxas.
Speaker Change: Today, we are sharing an update to our plans in metastatic PEDEC because earlier this year, Nellie Lee Fox was approved for first-line metastatic PEDEC after the NAPOLEC III trial.
Mark Erlander: Today, we are sharing an update to our plans in metastatic PDAC because earlier this year, Malary Fox was approved for first-line metastatic PDAC after the Policie trial shows significantly greater improvement in overall survival and progression speeds of survival with third-line Malary Fox compared to jamabraxing. As a result of this change to the first-line standard care, we have decided to support a first-line investigator-initiative PDAC trial that combines on-dancers with Malary Fox and recall that three of the four drugs that comprise the Malary Fox first-line regimen were the same drug combined with on-dancers in our prior second-line PDAC trial.
Speaker Change: shows significantly greater improvement in overall survival and progression-free survival with first-line malarie Foxx compared to Jama Braxen.
Mark Erlander: As a result of this change to the first-line standard of care, we have decided to support a first-line investigator-initiated PDAC trial that combines vancertix with NAL-A-RIV. And recall that three of the four drugs that comprise the NAL-Aryfox first-line regimen were the same drugs combined with Onbansertib in our prior second-line PDAC trial. This new trial will replace the first-line PEDAC investigator-initiated trial combining Pancertib with Gemma Braxen, which was still in the early stage and had not started to enroll patients. We will provide further updates on the UNDANCATIVE Mallory Fox Investigative Initiative trial in the coming months.
Speaker Change: As a result of this change to the first line stare of care, we have decided to support a first line investigator-initiated P-deck trial that combines on Vanceertic with now-Arival.
Speaker Change: And recall that three of the four drugs that comprise the Nel-Arifox first-line regimen were the same drug combined with Onbansertib in our prior second-line PDAC trial.
Speaker Change: This new trial will be placed the first line T-DAC Investigator Nishitral Combining on Pancertib with Gemma Braxton, which was built in an early stage and had not started to involve patients.
Mark Erlander: This new trial will be placed the first-line PDAC investigator-initiative trial combining on-dancers with jamabraxing, which was built in and early stage and had not started to involve patients. We will provide further updates on the on-dancers, Malary Fox investigator-initiative trial in the coming months.
Speaker Change: We will provide further updates on the UNDANCA-TIP Malarie Fox Investigative Initiative trial in the coming months.
Mark Erlander: Now I'd like to transition to the third item on our agenda, which is our continued success in identifying other cancer indications where Advancetib may be clinically efficacious. Previously, in preclinical studies, ondansetif has been shown to have activity in BRAS wild-type MCRC, ER-positive breast cancer, triple negative breast cancer, and platinum-resistant ovarian cancer. Last month, we published three clinical data on a new indication within ovarian cancer in the peer-reviewed journal Cell Death and Disease, which is a portfolio member of the journal Nature.
Speaker Change: Now I'd like to transition to the third item on our agenda, which is our continuous success in identifying other types of indications where on sensitive baby clinically efficacious.
Mark Erlander: Now, I would like to transition to the third item on our agenda, which is our continued success in identifying other cancer indications where on-dancers have made the clinically efficacious. Previously, in preclinical studies, on-dancers have been shown to have activity in grafts, wild-type MCRC, ER positive graft cancer, triple negative graft cancer, and platinum resistant ovarian cancer. Last month, we published preclinical data on a new indication within ovarian cancer. In the peer-reviewed journal, Cell Death and Disease, which is a portfolio member of the journal Nature.
Speaker Change: Previously, in brief clinical studies, on dance activities have been shown to have activity in graphs, wild type MCRC, ER positive drug cancer.
Speaker Change: triple-negative breast cancer, and platinum-resistant ovarian cancer.
Speaker Change: Last month, we published preclinical data on a new indication within Ovarian cancer in the peer-reviewed journal's cell death and disease, which is a portfolio member of the journal Nature.
Mark Erlander: Specifically, the data evaluate advances in ovarian cancers that are resistant to PARP inhibitors. In the published study, the combination of ondansir tip and allopurin, a PARP inhibitor approved endovirin, was tested both in vitro and in vivo in BRCA1-mutated and wild-type ovarian cancer models. In vitro, the combination of Oncantritib and Oloparib was synergistic in ovarian cancer cell lines and demonstrated inhibition of tumor growth. In vivo, the combination was well-tolerated, slowed tumor progression, and prolonged survival in patient-derived xenograft models resistant to Oloparib. Resistance to allopathy has been observed in clinical settings and has been a challenge to overcome.
Speaker Change: Specifically, the data evaluated on Bancet's humanitarian cancers that will be distant to part inhibitors. In the public study, the combination of on Bancet's hit and alloporid, a part inhibitor approved in the very cancer.
Mark Erlander: Specifically, the data evaluate on bancers who have been ovarian cancers that are resistant to park inhibitors. In the public study, the combination of on-dancerate and alloperate, a park inhibitor approved in ovarian cancer, was tested both in vitro and in vivo and lack of one mutated and wild-type ovarian cancer models. In vitro, the combination of on-dancers did in a lot of the synergistic in ovarian cancer cell lines and demonstrate inhibition at tumor growth.
Speaker Change: was tested both in vitro and in vivo in BRCA1 mutated and wild-type ovarian cancer models.
Speaker Change: In vitro, the combination of Onvancitib and Allopuribus synergistic in ovarian cancer cell lines and demonstrate inhibition of tumor growth.
Speaker Change: In vivo, the combination was well-tolerated, slowed tumor progression, and prolonged survival in patient-derived xenograft models resistant to allopurism.
Mark Erlander: In vivo, the combination was well tolerated, glowed to with progression, and prolonged survival in patients who ride zina graft models resistant to alloperate. Resistant to alloperate has been observed in clinical settings and has been a challenge to overcome. Moreover, these findings underscore the ability of on-dancers to overcome resistance to park inhibitors in high-grade serious ovarian carcinoma, which could make a significant impact in the treatment landscape of ovarian cancer cells, and Cancer.
Speaker Change: Resistance to a lot with Katherine's Earth in clinical settings and has been a challenge to overcome.
Mark Erlander: Moreover, these findings underscore the ability of Onvancitib to overcome resistance to PARP inhibitors in high-grade serious ovarian carcinomas, which could make a significant impact in the treatment landscape for ovarian cancer. Overall, we are still determining our path forward in ovarian cancer. However, we are highly encouraged by the totality of the data generated from our recent publication and AACR poster that demonstrate VASIR-T's ability to effectively resensitize ovarian cancer to treatment. Now I would like to turn the call over to Jamie to discuss our final agenda item, our second quarter 2024 financial outlook.
Speaker Change: Moreover, these findings underscore the ability of Onvancitib to overcome resistance to PARP inhibitors in high-grade serious ovarian carcinomas, which could make a significant impact in the treatment landscape for ovarian cancer.
Speaker Change: Overall, we are still determining our path forward in ovarian cancer, however we are highly encouraged by the totality of the data generated from our recent publication and AACR poster that demonstrate on VASR2's ability to effectively resensitize ovarian cancer to treatment.
Mark Erlander: Overall, we are still determining our path forward in the varying cancer, however we are highly encouraged by the totality of the data generated by my recent publication NAACR Closer, that demonstrates audacity to effectively restensitize the varying cancer to treatment.
Speaker Change: Now I would like to turn the call over to Jamie to discuss our final agenda item, our second quarter 2024 financial update.
Jamie Levine: Now, I would like to turn the call over to Jamie to discuss our final agenda item, our second quarter, 2024 Financial Update. Thank you, Marc. Earlier today, we issued a press release and filed a form 10Q with the FEC, which contained our financial results for the second quarter in the June 30th, 2024. Turning to our balance sheet, cash and short-term investments as of June 30th, 2024, total $60.3 million, and our cash used in operating activities was $9.2 million in Q2, 2024.
Jamie Levine: Earlier today, we issued a press release and filed a Form 10-Q with the FEC, which contained our financial results for the second quarter ending June 30, 2024. Turning to our balance sheet, cash and short-term investments as of June 30, 2024 totaled $60.3 million, and our cash used in operating activities was $9.2 million in Q2 2024. Today we're also updating our cash runway guidance based on our most up-to-date cash forecast. As a result, we believe that our current cash resources provide us with runway through the end of the third quarter of 2025, whereas previously we had expected runway into the third quarter of 2025. With that, I'll turn the call back over to Mark.
Jamie Levine: Thank you, Mark.
Jamie Levine: Earlier today, we issued a press release and filed a form 10Q with the FDC, which contain our financial results for the second quarter in the June 30th, 2024.
Jamie Levine: Turning to our balance sheet, cash and short-term investments as of June 30, 2024, total $60.3 million and our cash used in operating activities was $9.2 million in Q2, 2024.
Speaker Change: Today we're also updating our cash runway guidance based on our most up-to-date cash forecast.
Jamie Levine: Today, we're also updating our cash runway guidance based on our most up-to-date cash forecast. As a result, we believe that our current cash resources provide us with runway through the end of the third quarter of 2025, whereas previously, we had expected runway into the third quarter of 2025.
Speaker Change: As a result, we believe that our current cash resources provide us with runway through the end of the third quarter of 2025. Whereas previously, we had expected runway into the third quarter of 2025.
Speaker Change: With that, I'll turn the call back over to Mark.
Mark Erlander: I would now like to close the call by emphasizing our confidence in our clinical development strategy for our lead program in RAS mutated MCRC and enthusiasm for our upcoming data readout of CARDIS-004 later this year. Collectively, the data we have released throughout the past year, from our Phase 1B2 study, Ensembl Prime, and at AACR gives us conviction that adding Vancertib to standard care has the potential to change the treatment paradigm for the entire first-line RAS-mutated MCRC patient population.
Mark Erlander: With that, I'll turn the call back over to Marc. Thank you, Jamie.
Mark Erlander: Thank you, Jamie. I would now like to close the call by emphasizing our confidence in our clinical development strategy for our lead program in RAS mutated MCRC and enthusiasm for our upcoming data readout of CARDIS 004 later this year.
Mark Erlander: I would now like to close the call by emphasizing our confidence in our clinical development strategy for our LEAD program in RaspiTated MCRC and enthusiasm for our upcoming data readout of CAR-004 later this year. Collectively, the data we have released throughout the past year from our phase 1-B-2 study on thongal prime and F-A-A-C-R gives us conviction that adding on vantage tips to standard care has the potential to change the treatment paradigm for the entire first line RaspiTated MCRC patient population. And we believe that such an outcome would create enormous doubt for our stakeholders and possibly impact the large population patients living with RaspiTated MCRC.
Speaker Change: Collectively, the data we have released throughout the past year.
Speaker Change: From our Phase 1B-2 study, Ensembl-PRIME and FAACR gives us conviction that adding on Vancertib to standard care has the potential to change the treatment paradigm for the entire first-line graft-mutated MCRC patient population.
Mark Erlander: And we believe that such an outcome would create enormous value for our stakeholders and positively impact the large population of patients living with RAS-mutated MCRC. With that, I will now open the call to questions. Operator?
Speaker Change: And we believe that such an outcome would create enormous value for our stakeholders and positively impact the large population of patients living with RAS-mutated MCRC.
Speaker Change: With that, I will now open the call up for questions. Operator?
Kiki Patel: With that, I will now open the call up for questions. Operator? Thank you.
Operator: Thank you. We'll now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad. Then, raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. If you are called upon to ask a question and are listening via a loudspeaker on your device, please pick up your handset, and make sure that your phone is not on mute when asking a question. And your first question comes from the line of Mark Frahm of TD Cowen. Please go ahead.
Speaker Change: Thank you. We'll now begin the question and answer session. If you have dialed in and would like to ask the question, please press star 1 on your telephone keypad, raise your hand and join the queue.
Operator: We'll now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad. Raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. If you are called upon to ask a question and are listening via loudspeaker on your device, please pick up your handset and make sure that your phone is not on mute when asking your question.
Speaker Change: If you would like to withdraw your question, simply press star 1 again. If you are called upon to ask a question and are listening via a loudspeaker on your device, please pick up your handset.
Speaker Change: and make sure that your phone is not on mute when asking your question.
Speaker Change: And your first question comes from the line of Mark Frahm of TD Cowen. Please go ahead.
Mark Fram: And your first question comes from the line of Mark Fram of TD Cowan.
Mark Frahm: I think for taking my question, maybe first off, last quarter, you don't know that Roman Worment Trends in the O4 trial had been a bit slower than you anticipated when you opened the trial. I'm curious, has that kind of help study, has that Roman help study over the summer, or have you seen some acceleration in that Roman trend?
Mark Erlander: Please go ahead. I think for taking my question maybe first off the last quarter you donated that can be enrollment trends in the O4 trial had maybe been a bit slower than you anticipated when you opened the trial. I'm just curious, has that kind of helped steady over the summer or have you seen some acceleration in that enrollment trend? Thanks, Mark. Enrollment is tracking quite well and is tracking with our guidance of having an initial look at the data later this year.
Mark Frahm: Thanks for taking my questions. Maybe first off, last quarter you noted that enrollment trends in the OO4 trial had maybe been a bit slower than you'd anticipated when you opened the trial.
Speaker Change: I'm curious if it has that kind of help steady over the summer or have you seen some acceleration in that minimum trend?
Mark Erlander: Thanks Mark. Enrollment is tracking quite well and is in line with our guidance of having an initial look at the data later this year. And part of the reason why we're doing well is because we have Pfizer-Ignite as a strong partner and we've been able to leverage a lot of their capabilities and be able to drive the enrollment. I think the other things that really do help that I mentioned earlier on the call are that there have been no new drugs for 20 years for these RAS mutated patients in first line and CRC, and also importantly, there are no To answer your question, yes, we're on track with the guidance of an initial look later this week.
Speaker Change: Thanks Mark. Enrollment is tracking quite well and is tracking with our guidance of having an initial look at the data later this year.
Speaker Change: And, you know, part of the reason why it's...
Mark Erlander: And part of the reason why we're doing well is because we have Pfizer Ignite as a strong partner and we've been able to leverage a lot of their capabilities and being able to drive the enrollment. I think the other things that really do help that I mentioned earlier on the call is that there are no new drugs for 20 years for these RASMETATED patients in first line in CRC. And also importantly, there are no competing trials. So to answer your question, yes, we're on track with the guidance of initial look later this year.
Speaker Change: We're doing well is because we have Pfizer Ignite
Speaker Change: as a strong partner and we've been able to leverage a lot of their capabilities.
Speaker Change: and being able to drive the enrollment. I think the other thing that really do help that I mentioned earlier on the call is that there are no new drugs for 20 years for these graft-mutated patients in first line in CRC. And also, importantly, there are no competing trials.
Mark Fram: Okay, thanks. It's very helpful.
Speaker Change: To answer your question, yes, we're on track with the guidance of initial look later this year.
Mark Erlander: Okay, thanks, that's very helpful. And then maybe on the pancreatic trial that you are going to start. I think, you know, Nalperinox has obviously been approved, but at least in our conversations with physicians, it's not 100% clear that it's going to get broadly adopted as a true kind of broad standard of care. So, I guess, why be kind of aggressive in adopting that now for this initial proof of concept in pancreatic versus maybe using some of the older regimens that are also potentially a bit better tolerated than that regimen? Yeah, really two answers to that question.
Speaker Change: Okay, thanks, that's very helpful. And then maybe on the pancreatic trial that you are going to start up.
Mark Fram: And then maybe on the pancreatic trial that you are going to start up. I think, you know, now if your knocks are obviously been approved, but at least in our conversations with physicians, it's not 100% clear that it's going to get broadly adopted as a true kind of broad standard of care.
Speaker Change: I think, you know, no fear, noxious art has obviously been approved, but at least in our conversations with physicians, it's not 100% clear that it's going to get broadly adopted as a true kind.
Speaker Change: broad standard of care. So I guess why
Mark Erlander: So I guess why be kind of aggressive on adopting that now for this initial proof of concept for pancreatic versus maybe using some of the older regimens that are also potentially a bit better tolerated than that regimen? Yeah, really two answers to that question. I mean, the first is that the now-airry Fox, really three of the four chemo agents, we've already combined with on the answer tip and second line have good data from that.
Speaker Change: Dick kind of aggressive on adopting that now for this initial proof of concept for in pancreatic versus maybe using some of the older regimens that are also potentially a bit better tolerated than that regimen.
Mark Erlander: Yeah, really two answers to that question. I mean, the first is that now Airy-Fox, really three of the four chemo agents we've already combined with on Vancertip and Secondline have good data from that. And so we, you know, we believe that, along with our preclinical work in this area. So that's really the first part of the answer to the question.
Speaker Change: Yeah, two answers to that question. I mean, the first is that the now-airy fox really three of the four chemo agents.
Speaker Change: We've already combined with Onvancer, TIP, and Secondline and have good data from that. And so we, you know, we believe that along with our preclinical work in this area. So that's really...
Mark Erlander: And so we believe that along with our pre-clinical work in this area. So that's really the first part of the answer to the question. The second is really that we are showing really good tolerability of on the answer tip in combination with these chemo agents. And really the only chemo that we haven't combined it with is the oxalic platin, which is part of the now-airry Fox. But really, oxalic platin really does not have any overlapping toxicities with on the answer tip.
Mark Erlander: The second is that we are showing really good tolerability of Onvancertip in combination with these chemo agents. And really, the only chemo that we haven't combined it with is Oxaliplatin, which is part of the now Airy-Fox. But really, Oxaliplatin really does not have any overlapping toxicities with Onvancertip. So we do feel confident that we can come in with this more aggressive chemo and combine and add value to that. Because we believe that this is really the type of regimen that is showing superiority and efficacy in first.
Speaker Change: The first part of the answer to the question. The second is really that we are showing a really good tolerability of on-dancertip in combination with these chemo agents, and really the only chemo that we haven't.
Speaker Change: combined it with is the oxaliplatin, which is a part of the null-ary fox, but really oxaliplatin really does not have any
Speaker Change: overlapping toxicities with ondansyrtis. So we do feel confident that we can come in
Mark Erlander: So we do feel confident that we can come in with this more aggressive chemo and combining and adding value to that because we believe that this is really the type of regimen that is showing the superiority in efficacy in first line.
Speaker Change: with this more aggressive chemo and combining and adding value to that because we believe that this is really the type of regimen that is showing the superiority in efficacy in first line.
Operator: Your next question comes from the line of Andy Shea of Will and Blair. Please go ahead.
Speaker Change: Okay, thank you.
Mark Erlander: Okay, thank you.
Speaker Change: Your next question comes from the line of Andy Shea of William Blair. Please go ahead.
Andy Scheff: Your next question comes from the line of Andy Scheff of William Blair. Please go ahead. Great. Thanks for taking our question. Maybe an extent from Mark's question earlier in the call.
Andy Shea: Great. Thanks for taking our questions. Maybe to extend from Mark's question earlier in the call, I'm just curious about, you know, whether you could comment on the level of excitement and kind of scientific validation with the change of the IST in pancreatic cancer. Obviously, I think it's well-validated for the answer to synergy with adrenal TCAM, which is now included in the regimen versus the general Braxane regimen before. I'm curious about your view on that.
Andy Shea: Good. Thanks for taking our question. Maybe I have access from Mark's question earlier.
Andy Shea: I'm just curious about, you know, whether you could comment on the level of excitement and kind of scientific validation with the change of the IST in pancreatic cancer.
Mark Erlander: I'm just curious about, you know, whether you could comment on the level of excitement and kind of scientific validation with the change of the IST in pancreatic cancer. Obviously, I think it's well validated that on the answer tip, synergy with the Reno TKM, which is now included in the regimen versus the general vaccine regimen before. I'm curious about your view on that.
Speaker Change: Obviously, I think it's well-validated that on the answer to synergy with Irino TKM, which is now included in the regimen versus the Gemma Braxane regimen before. I'm curious about your view on that.
Mark Erlander: In terms of the potential ovarian cancer entry, there's obviously new therapy for ovarian cancer in the form of ADCs. So you've looked at chemotherapy, you've looked at targeted therapy, combinations, PARP. So just curious about whether you've done or plan to do any sort of combinatorial work in the ADC field as well. Thanks.
Mark Erlander: In terms of the, you know, conventional, sobering, cancer entry, there's a, you know, obviously new therapy, no cancer in a form of ADCs. So you looked at chemotherapy, you look at target therapy, you know, combinations, you know, parps. So it's curious about whether you've done or planned to do any sort of combinatorial work in the ADC field as well.
Speaker Change: In terms of the potential ovarian cancer entry,
Speaker Change: There's a, you know, obviously new therapy for cancer in the form of ADCs, so you've looked at chemotherapy, you've looked at target therapy, you know, combinations, you know, PARPs,
Speaker Change: So, curious about whether you've done or planned to do any sort of commentatorial work in the ADC field as well. Thanks.
Mark Erlander: Thanks, Andy, for both of those questions. I'd say to answer your first question, really, the IRENA-Tcan synergy is one of the main reasons we are going with the combination of Malarie Fox and Firstline. Also, the PI that we're working with for this new investigative-initiated trial has already had experience in our Secondline pancreatic trial and really was a huge proponent and enthusiastic about going into Firstline. So that was really, he knows our drug, he knows it's well-tolerated, and he's very excited about going into Firstline.
Speaker Change: Oh, thanks Andy for both of those questions. I'd say to answer your first question, really the Irena T. Kent Synergy is one of the main reasons we are going with the combination with Mallory Fox and Firstline.
Mark Erlander: Thanks. Thanks, Andy, for both of those questions. I think to answer your first question, really the, I mean, the TCAN synergy is one of the main reasons we are going with the combination with Nellery Fox and First Line. Also, our, the PI that is, that we're working with for this new, Investigative Nishade trial, has already had experience in our second-mind pancreatic trial and, and really was the huge proponent enthusiastic in going into First Line.
Speaker Change: also are the PI that is...
Speaker Change: that we're working with for this new investigative-initiated trial has already had experience in our second-line pancreatic trial and really was a huge proponent and enthusiastic in going into first-line.
Speaker Change: So that was really, he knows our drug, he knows it's well tolerated, and he's very excited about going into first line.
Mark Erlander: So that was really, he knows our drug, he knows it's well tolerated, and he's very excited about going into First Line. To answer your other question about ovarian cancer in ADC combination, we are currently preclinically looking at ADCs in combination with non-vancer tips, not only, you know, ovarian, not specific, only on ovarian, but we are all, we are really exploring that in several other areas that, where ADCs have been approved.
Mark Erlander: To answer your other question about ovarian cancer and ADCs, we are currently pre-clinically looking at ADCs in combination with Don Vanster's tip. Not only, you know, ovarian cancer, not specific only to ovarian cancer, but we are really exploring that in several other areas where ADCs have been approved.
Speaker Change: To answer your other question about ovarian cancer and ADC combination, we are currently preclinically looking at ADCs in combination.
Don Vansterjip: with Don Vansterjip, not only ovarian, not specific only on ovarian, but we are really exploring that in several other areas where ADCs have been approved.
Mark Erlander: That's helpful. Thank you so much. Sure. Thanks, Andy.
Speaker Change: That's helpful. Thank you so much. Sure. Thanks, Andy.
Operator: Again, if you would like to ask a question, press star, then the number 1 on your telephone keypad. There are no more questions. I will now turn the conference back over to Mark Erlander for closing remarks.
Speaker Change: Again, if you would like to ask a question, press star, then the number 1 on your telephone keypad.
Speaker Change: Kiki Patel, Mark Erlander, Fairooz Kabbinavar, Fairooz
Don Vansterjip: There are no more questions. I will now turn the conference back over to Mark Erlander for closing remarks.
Mark Erlander: Thank you, Operator. And this concludes our conference call. Thank you again, everybody, for joining us this afternoon. Good day. Ladies and gentlemen, that concludes today's call. Thank you all for joining us. You may now go.
Mark Erlander: Thank you, Operator. And this concludes our conference call. Thank you again, everybody, for joining us this afternoon. Good day.
Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining us; you may now disconnect. [music]
Speaker Change: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.
Speaker Change: Kiki Patel, Mark Erlander, Fairooz Kabbinavar, Fairooz Kabbinavar, Fairooz Kabbinavar, Fairooz Kabbinavar, Fairooz Kabbinavar, Fairooz
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Fairooz Kabbinavar: www.FairoozKabbinavar.com www.FairoozKabbinavar.com
Andy Scheff: That's helpful. Thank you so much. Sure. Thanks, Andy.
Operator: Again, if you would like to ask a question, press star, then the number one on your telephone keypad.
Operator: There are no more questions.
Mark Erlander: I will now turn the conference back over to Mark Orlando for closing remarks.
Operator: Thank you, operator, and this concludes our conference call. Thank you again, everybody, for joining us this afternoon.
Operator: Good day.
Operator: Ladies and gentlemen, that concludes today's call.
Kiki Patel: Thank you all for joining. You may now[inaudible] Thank you for your time, thank you[inaudible] Thank you for your time, thank you for your time, thank you[inaudible] Thank you for your time, thank you for your time, thank you for your time[inaudible] Thank you for your time, thank you for your time[inaudible] Thank you for your time, thank you for your time[inaudible] Marc Frahm, Joseph Catanzaro, Laurence Watts Marc Frahm, Joseph Catanzaro, Laurence Watts Marc Frahm, Joseph Catanzaro, Laurence Watts, James Levine, Marc Frahm, Joseph Catanzaro, Laurence Watts Marc Frahm, Joseph Catanzaro, Laurence Watts Marc Frahm, Joseph Catanzaro, Laurence Watts, James Marc Frahm, Joseph Catanzaro, Laurence Watts, James Levine, Marc Frahm, Joseph Catanzaro, Laurence Watts, Marc Frahm, Joseph Catanzaro, Laurence Marc Frahm, Joseph Catanzaro, Laurence Watts Marc Frahm, Joseph Catanzaro, Laurence Watts, James Levine Marc Frahm, Joseph Catanzaro, Laurence Watts Marc Frahm, Joseph Catanzaro, Laurence Watts, James Levine, Joseph Catanzaro, Laurence Kiki Patel, of Guild Martin Group.
Kiki Patel: Please go ahead. Thank you, operator.
Mark Erlander: Joining us on the call today, from Cardiff Oncology, are Chief Executive Officer, Mark Erlander, and Chief Financial Officer, Jamie Levine. During this conference call, management will make forward-looking statements, including without limitations, statements related to guidance, results, and the timing of data readouts for our advanced literature clinical trials. These forward-looking statements are based on the company's current expectations and inherently involved significant risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated and such forward-looking statements as a result of these risks and uncertainties.
Mark Erlander: Factors that could cause the results to be different from these statements include factors that the company describes in the section titled Risk Factors, and its annual report on form 10K filed with the FEC for the year ended December 31, 2023.
Mark Erlander: Cardiff Oncology undertakes no duty or obligations to update any forward-looking statements as a result of you information, future events, or changes in its expectations.
Mark Erlander: With that, I turn the call over to Chief Executive Officer, Mark Erlander. Mark?
Mark Erlander: Thank you, Kiki, and good afternoon, everyone, and thank you for joining our Business Update Conference call for the second quarter of 2024. These are certainly energizing times that Cardiff Oncology, as we activate scythe enroll patients in our Cardiff 004 trial in Rascutated, Medesthetical Retrocancer for MCRC. The interactions we're having with the positions and other professionals at the trial site reinforce our own excite at the potential to bring a more effective therapy to this large patient population of nearly 50,000 new patients a year in the U.S, alone, specifically the totality of the data, the more phased on V2 and ensemble second-line MCRC trials, demonstrates on bancer tubes has the potential to shift the treatment paradigm for all Rascutated MCRC, not just subgroups to pay rise.
Mark Erlander: We say this because first, there has been no new therapy to prove for these patients over the past 20 years. Second, there are no competing clinical trials for this patient population. And third, unlike prior field K1 inhibitors, on bancer tube is well tolerated when combined with chemotherapy, which also opens the door to other chemo combination for additional cancer indications.
Mark Erlander: So let's dive in, on today's call we will cover four topics. First, I will discuss our lead program, an MCRC, and provide updates around our ongoing part of 004 trials. Second, I will provide an update on our pancreatic cancer program. Third, I will provide a brief overview of our continued encouraging pre-clinical data demonstrating on bancer tube activity and other cancer indications with unmet clinical needs beyond Rascutated MCRC. And finally, we will talk about our financial position that we disclose today in our form 10Q.
Mark Erlander: So let's begin. This quarter, we have been intensely focused on the clinical execution of our cart of 004 trials, evaluating the contribution of on bancer tube in first line, Rascutated MCRC. As a reminder, cart of 004 is our ongoing phase 2 trial, evaluating on bancer tube in combination with cart standard care, which consists of either full period plus bed or full-fog plus bed. The trial is currently active in 33 sites, and we plan to enroll 90 patients who will be randomized to receive either a 20 milligram or a 30 milligram dose of bancer tube plus standard care or standard care alone.
Mark Erlander: Our team that cart of oncology alongside our clinical execution partner Pfizer's NICE is diligently working on the enrollment of the trial. We continue to leverage Pfizer's resources and capabilities in multiple areas to drive enrollment. We also appreciate the commitment and the clinical efforts of our enthusiastic investigators who have been to judiciously screening patients across our active sites. Based on the current pace of enrollment over the past few months, we continue to plan on releasing an initial data readout later this year as we previously guided. We expect this will include objective response rate data for approximately half of the patients who glans in the role in the trial.
Mark Erlander: Now I'd like to turn to our second agenda item. An update on our Pancreatic Cancer Program focused on metastatic pancreatic ductal adenocarcinoma or PDAX. In September of last year, we released data from our Phase 2 trial for metastatic PDAX in the second line step. In this single arm trial, patients who see on-dancers in combination with the chemotherapy regimen of liposomal aridity can, lukewarm and side-of-use. After discussing the results with our investigators, we decided the next step of our PDAX program would be an investigator-initiated trial in the first line study combining on-dancers tips with shared-of-care jam-abraxing.
Mark Erlander: Today, we are sharing an update to our plans in metastatic PDAX because earlier this year, NALIRI FOX was approved for first-line metastatic PDAX after the polyprytrial shows significantly greater improvement in overall survival and progression-freeze-of-vival with first-line NALIRI FOX compared to jam-abraxing. As a result of this change to the first-line standard care, we have decided to support a first-line investigator-initiated PDAX trial that combines on-dancers tips with NALIRI FOX, and recall that three of the four drugs that comprise the NALIRI FOX first-line regimen were the same drug combined with on-dancers tips in our prior second-line PDAX trial. This new trial will be placed the first-line PDAX investigator-initiated trial combining on-dancers tips with jam-abraxing, which was built in an early stage and had not started to enroll patients.
Mark Erlander: We will provide further updates on the on-dancers tips, NALIRI FOX investigative trial in the coming months.
Mark Erlander: Now, I'd like to transition to the third item on our agenda, which is our continued success in identifying other cancer indications where on-dancers tips may be clinically efficacious. Previously, in pre-clinical studies, on-dancers tips have been shown to have activity in grass wild-type MCRC, ER positive breast cancer, triple negative breast cancer, and platinum resistance ovarian cancer.
Mark Erlander: Last month, we published pre-clinical data on a new indication within ovarian cancer in the peer-reviewed journal Cell Death and Disease, which is a portfolio member of the journal Nature. Specifically, the data validates on-dancers who have been ovarian cancers that are resistant to part inhibitors. In the public study, the combination of on-dancers tips and elaborate a part inhibitor-approving ovarian cancer was tested both in vitro and in vivo and lack of one mutated and wild-type ovarian cancer models. In vitro, the combination of on-dancers tips and elaborate but synergistic in ovarian cancer cell lines and demonstrate inhibition of tumor growth. In vivo, the combination was well tolerated, flowed to a progression, and for long survival.
Mark Erlander: In patients-arrived, zinegraphe models resistant to ovarian cancer cell Resistence to a Lockwood has been served in clinical setting and has been a challenge to overcome. Warworth, these findings underscored the ability of on-density to overcome resistance to partner inhibitors in high-grade serious ovarian carcinoma, which could make a significant impact in the treatment landscape for ovarian cancer.
Mark Erlander: Overall, we are still determining our path forward in ovarian cancer, however, we are highly encouraged by the fatality of the data generated from a recent publication and an ACR poster that demonstrates on-density to the ability to effectively restensitize ovarian cancer to treatment.
Jamie Levine: Now, I would like to turn the call over to Jamie to discuss our final agenda item, our second quarter, 2024 financial update. Thank you, Marc. Earlier today, we issued a press release and filed a form 10Q with the FEC, which contained our financial results for the second quarter in the June 30, 2024. Turning to our balance sheet, cash and short-term investments as of June 30, 2024 totaled $60.3 million, and our cash used in operating activities was $9.2 million in Q2 2024.
Jamie Levine: Today, we're also updating our cash runway guidance based on our most up-to-date cash forecast. As a result, we believe that our current cash resources provide us with runway through the end of the third quarter of 2025, whereas previously, we had expected runway into the third quarter of 2025.
Mark Erlander: With that, I'll turn the call back over to Marc. Thank you, Jamie.
Mark Erlander: I would now like to close the call by emphasizing our confidence in our clinical development strategy for our LEAD program in Rasputated MCRC, and enthusiasm for our upcoming data readout of CAR-004 later this year. Collectively, the data we have released throughout the past year from our Phase 1-B-2 study, Ensemble time, and FAACR, gives us conviction that adding on banter tip to standard care has the potential to change the treatment paradigm for the entire first line Rasputated MCRC patient population. And we believe that such an outcome would create enormous doubt for our stakeholders and publicly impact the large population of patients living with Rasputated MCRC.
Kiki Patel: With that, I will now open the call up for questions. Operator? Thank you. We'll now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad. Raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. If you are called upon to ask a question and are listening via loudspeaker on your device, please pick up your handset and make sure that your phone is not on mute when asking your question.
Mark Fram: And your first question comes from the line of Mark Fram of PD Cowan. Please go ahead. Thank you for taking my question. Maybe, first off, last quarter, you donated that kind of enrollment trends in the O4 trial had maybe been a bit slower than you anticipated when you opened the trial. I'm just curious, has that kind of helped steady, has that enrollment helped steady over the summer, or have you seen some acceleration in that enrollment trend?
Mark Fram: Thanks, Mark. Enrollment is tracking quite well and is tracking with our guidance of having an initial look at the data later this year. And part of the reason why we're doing well is because we have Pfizer Ignite as a strong partner, and we've been able to leverage a lot of their capabilities in being able to drive the enrollment. I think the other things that really do help that I mentioned earlier on the call is that there are no new drugs for 20 years for these rough, mutated patients in first line in CRC, and also importantly, there are no competing trials. To answer your question, yes, we're on track with the guidance of initial look later this year. Okay, thanks. It's very helpful.
Mark Fram: Then maybe on the pancreatic trial that you are going to start up. I think, you know, no fear, nonexious art, obviously been approved, but at least in our conversations with physicians, it's not 100% clear that it's going to get broadly adopted as a true kind of broad standard of care.
Mark Erlander: So I guess why be kind of aggressive on adopting that now, kind of for this initial proof of concept for pancreatic versus maybe using some of the older regimens that are also potentially a bit better tolerated than that regimen? Yeah, really two answers to that question. I mean, the first is that the now-airry Fox, really three of the four chemo agents, we've already combined with on Vansertip in second line have good data from that.
Mark Erlander: And so we believe that with along with our preclinical work in this area. So that's really the first part of the answer to the question. The second is really that we are showing really good tolerability of on Vansertip in combination with these chemo agents. And really the only chemo that we haven't combined with is the oxali platin, which is part of the now-airry Fox, but really oxali platin really does not have any overlapping toxicities with on Vansertip.
Mark Erlander: So we do feel confident that we can come in with this more aggressive chemo and combining and adding value to that because we believe that this is really the type of regimen that is showing the superiority in efficacy in first line. Okay, thank you.
Andy Scheff: Your next question comes from the line of anti-share of Willem Blair. Please go ahead. Great. Thanks for asking our question. Maybe I have an accident from Mark's question earlier in the call. I'm just curious about You know, whether you can comment on the level of excitement and kind of scientific validation with the change of the IST in pancreatic cancer, obviously I think it's well validated that on the answer to synergy with the Reno T-CAM which is now included in the Regimen versus the younger Braxing Regimen before.
Andy Scheff: I'm curious about your view on that. And then in terms of the, you know, conventional, sobering cancer entry, there's a, you know, obviously new therapy, no cancer in a form of ADCs, so you look at chemotherapy, you look at target therapy, you know, combinations. You know, part, so curious about whether you've done or planned to do any sort of combinatorial work in the ADC field as well. Thanks. Oh, thanks, Andy, for both of those questions.
Andy Scheff: I think to answer your first question, really the, I mean, the T-CAM synergy is one of the main reasons we are going with the combination with Nellery Fox and First Line. Also our, the PI that is, that we're working with for this new investigate initiated trial has already had experience in our second line pancreatic trial and really was the huge proponent enthusiastic in going into First Line. So that was really, he knows a drug, he knows it's well tolerated and he's very excited about going into First Line.
Andy Scheff: To answer your other question about ovarian cancer and ADC combination, we are currently preclinically looking at ADCs in combination with non-vancerative, not only, you know, a variant not specific only on variant, but we are, we are really exploring that in several other areas that where ADCs have been approved. That's helpful. Thank you so much. Sure. Thanks, Andy. Again, if you would like to ask a question, press star, there's a number one on your telephone keypad.
Operator: There are no more questions.
Mark Erlander: I will now turn the conference back over to Mark Orlando for closing remarks. Thank you, operator.
Operator: And this concludes our conference call. Thank you again, everybody, for joining us this afternoon. Good day.
Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now.