Q1 2024 Cardiff Oncology Inc Earnings Call

May 2, 2024

Okay.

Operator: Welcome to the Cardiff Oncology First 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 1-1 on your telephone, and you will hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Kiki Patel of Gilmartin Group. Please go ahead.

Speaker Change: Welcome to the goddess of oncology first 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 one.

Speaker Change: On your telephone and you will hear an automated message of dicing your hand this waste.

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

Gilmartin group: I'd now like to turn the conference over to keep the Chow of Gilmartin Group. Please go ahead.

Gilmartin group: Thank you operator, joining us on the call today requires oncology, our chief Executive officer, Mark or lender and Chief Financial Officer, Jamie Levine.

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. During this conference call, management will make four forward-looking statements, including, without limitation, statements related to guidance, results, and the timing of data readouts for unadvanced 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.

This conference call management will make forward looking statements, including without limitation statements related to guidance and it's finding a theater readouts for on vantage a clinical trial.

Gilmartin group: 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 factors that could cause results to be different from these statements include factors the company.

In the section titled Risk factors in our annual report on Form 10-K filed with the SEC for the year ended December 31 2023.

Gilmartin group: Hardeep oncology undertakes no duty or obligation to update any forward looking statements as a result of new information future events or changes in its expectation with that I turn the call over to Chief Executive Officer, Mark Erlendur, Mark well. Thank you Katie and good afternoon, everyone and thank you for joining our call.

Kiki Patel: Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in its annual report on Form 10-K filed with the SEC for the year ended December 31, 2023. 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. Mark? Well, thank you, Kiki.

Mark Erlander: Thank you, Kiki, and good afternoon, everyone, and thank you for joining our conference call for the first quarter of 2024 Business Update. It was less than a year ago that we announced that our clinical development plan for advanced disease would focus on the first-line treatment of RAS-mutated metastatic colorectal cancer, or MCRC. The data we shared last August supported this, and our focus on first-line MCRC addresses a large patient population: almost 50,000 new patients a year in the United States for whom there have been no new therapies approved in 2015. In the first quarter of 2024, three data sets added to the body of evidence supporting our first-line focus strategy.

Mark Erlander: This call for the first quarter of 2020 for business update.

Mark Erlander: It was less than a year ago that we announced that our clinical development plans for investors to focus on the first line treatment of RAF mutated metastatic colorectal cancer or CRC.

Mark Erlander: Data, we shared last August supported us.

Mark Erlander: And our focus on first time first one <unk> addresses a large patient population almost 50000, new patients a year in the United States for whom there have been no new therapies approved in 20 years.

Mark Erlander: The first was the ENSEMBLE data, which served as an independent and randomized data set that replicated the efficacy signals in VAB-naive patients observed in our Phase 1b2 trial. Second, were five posters presented at the annual meeting of the American Association for Cancer Research, or AACR. And finally, was the publication of data in the peer-reviewed journal, Clinical Cancer Research, from the Phase 1b portion of our Phase 1b2 KWACS-mutated MCRC trial. I want to emphasize our conclusion that the collective data released in Q1 strongly supports our finding that adding on Vancouver, Standard of Care Opioid and Medicine Lab, which I will refer to as BEV, has significantly, has significant effect, and RAP-treated Now, during today's call, we have three topics to cover.

Mark Erlander: In the first quarter of 2024.

Mark Erlander: Three dataset added to the body of evidence supporting our ports line focused strategy.

Mark Erlander: First was the ensemble data, which served as an independent and randomized dataset that replicated the efficacy signal and Bev naive patients observed in our phase <unk> trial.

Gilmartin group: With our five posters presented at the annual meeting of the American Association for cancer research or <unk>.

Gilmartin group: And finally was the publication of data in the peer reviewed journal clinical cancer research from the phase <unk> portion of our phase <unk> K Ras mutated <unk> trial.

I want to emphasize our conclusion that the collective data released in Q1 strongly support our findings that adding on vantage to tier two status care, all theory, and Bevacizumab, which I will refer to as Beth has significantly have significant efficacy and RAF mutated MGIC.

Gilmartin group: Patients that are bev naive patients.

Gilmartin group: Patients that have had no prior treatment with Beth.

Speaker Change: Now during today's call we have three topics to cover first I will provide a summary of the promising data we presented last month at ACR.

Mark Erlander: First, I will provide a summary of the promising data we presented last month at AACR. Next, we will discuss our LEAD program and MCRC and provide updates on our ongoing Cardiff 004 trial. And finally, we'll talk about our financial position that we disclosed today in our Form 10-Q. So let's begin.

Gilmartin group: We will discuss our lead program, an NCIC and provide updates around our ongoing cardiac zero-zero fourth.

Gilmartin group: And finally, we'll talk about our financial position that we disclosed today in our Form 10-Q.

Speaker Change: So let's begin.

Mark Erlander: Last month, the American Association for Cancer Research held its 2024 annual meeting in San Diego, in which Cardiff Oncology presented a total of five post-op studies, all of which are available on our website. One poster describes the design of our ongoing study for Cardiff 0045, and a second poster presented data that supports our first line strategy in MCRC by providing new translational data from our phase 1b2 trial and second line KRAS mutated Three additional posters shared promising preclinical data in other cancer indications, including RAS wild-type MCRC, small-cell lung cancer, and ovarian cancer, demonstrating the broad opportunities we see for our advanced ahem, I would like to highlight some of the important data we presented in the poster on our LEAD program and RAS mutated...

Speaker Change: Last month, the American Association for Cancer Research held as 2024 annual meeting in San Diego, and which card up oncology presented a total of five posters all of which are available on our website.

Gilmartin group: One poster described the design of our ongoing part of our portfolio.

Gilmartin group: Our second poster presented data that support our first line strategy and Mcse by providing new translational data from our phase <unk> trial in second line K, Ras mutated and CRC.

Gilmartin group: The rate of additional posters shared promising preclinical data in other cancer indications, including Ras Wild type <unk> small cell lung cancer and ovarian cancer, demonstrating the broad opportunity, we see on the answer to that.

I would like to highlight some of the important data we presented in the poster on our lead program and Ras mutated in CFC.

Mark Erlander: In this poster, we presented both clinical data from the Phase I-II trial and subsequent data from preclinical studies that form the basis of the scientific rationale for our clinical findings. We also demonstrated that BAB-9 patients within this trial had a higher objective response rate and longer progression. The additional preclinical data disclosed at AACR provides further evidence that Onfantacetib and Feb have their pharmacological effects at two different nodes of the hypoxia pathway. (Inaudible) that work in a synergistic manner, giving a one-two punch to the tumor.

Gilmartin group: And this poster we presented both clinical data from the phase one two trial and subsequent data from preclinical studies that forms the basis of the scientific rationale for clinical findings.

Gilmartin group: We also demonstrated that bev naive patients within within this trial had a higher objective response rate and a longer progression free survival.

Gilmartin group: The additional preclinical data clinical data disclosed at ACR provides further evidence that our advantage isn't that have their pharmacological effect at two different nodes of the hypoxia pathway.

We hypothesize that on vaccines and that work in a synergistic manner, given a one two punch to the tumor or.

Mark Erlander: Our hypothesis was further strengthened by our preclinical in vivo data and 3K Ras-Mutant MCRC Xenograft models. Combination treatment with Onvancer TIF plus BED resulted in significantly superior anti-tumor activity compared to monotherapy with either agent. And importantly, the combination treatment also resulted in a greater decrease in tumor vascularization compared to either agent. This finding provides rationale for further exploration of the combination of ondansetib and BEV in additional indications where BEV is FDA-approved.

Gilmartin group: Our hypothesis was further strengthened by our preclinical in vivo data in <unk> mutant <unk> models combination treatment with <unk> plus bet resulted in significant superior anti tumor activity compared to monotherapy with either agent and importantly, the combination treatment.

Gilmartin group: Also resulted in a greater decrease in tumor vascularization compared to either agent alone.

Gilmartin group: This finding provides rationale for further exploration of the combination of on vantage had been back in additional in additional indications where bet. It's FDA approved.

Gilmartin group: Yes.

Gilmartin group: Collectively the clinical and preclinical data presented at ACR in RAF mutated second line Mcse provides further validation of our ongoing <unk> trial we.

Mark Erlander: Collectively, the clinical and preclinical data presented at AACR in RAS-mutated second-line MCOS provide further validation of our ongoing Cardiff 004 trial. We believe Onvancitib will have a significant impact in the first line setting given that all patients are defnitive.

We believe on Vansittart will have a significant impact in the first line setting given that all patients are.

Gilmartin group: Now, let's move on to our additional posters presented at ACR in therapeutic areas outside of our core focus of Ras mutated and CRC today most of the data we have generated in an NCIC has been in Ras mutated patients and we are often asked.

Mark Erlander: Now let's move on to our additional posters presented at AACR in therapeutic areas outside of our core focus of RAS-mutated MCRP. To date, most of the data we have generated in MCOC has been in RAS-mutated patients, and we are often asked if our therapy could work for patients who do not have a RAS mutation. At ACR, we shared encouraging preclinical data in RAS wild-type MCOC, meaning these models were derived from patients who did not have a RAS mutation.

Gilmartin group: If our therapy could work for patients who do not have a ras mutation.

Gilmartin group: At ACR, we shared encouraging preclinical data in Ras Wild type and CRC, meaning these models were derived from patients who did not have a ras mutation.

Mark Erlander: Our preclinical study in RAS wild-type MCRC patient-derived VenoGraft or PBX models aimed to assess the efficacy of ondansetib as monotherapy and in combination with the EGFR inhibitor, Tuximab, which is the standard of care for RAS wild-type MCRC patients. We evaluated models that were both sensitive to Cetuximab and resistant to Cetuximab. In summary, Onvancetib displayed robust anti-tumor activity as a single agent in Cetuximab-sensitive and resistant PDX models. As for combination therapy, efficacy was enhanced when Onvancetib and Cetuximab were combined compared to monotherapy of either agent alone.

Gilmartin group: Our preclinical study and Ras Wild type and CRC patient derived xenograft or pdx models aimed to assess the efficacy of <unk> as monotherapy and in combination with the Egfr inhibitor <unk>, which is the standard of care for <unk> Wild type and CRC patients we have.

Gilmartin group: Evaluated models that were both sensitive to deduct the mab and resistant to Cetuximab and.

Gilmartin group: In summary on Bachelor chip displayed robust anti tumor activity as a single agent and so talks about sensitive and resistant pdx model as for combination therapy efficacy was enhanced when <unk> talks about where combined compared to monotherapy of either agent alone.

Mark Erlander: In combination, Onbanser-Tibb and Satuximab induced tumor stasis or regression in 90% or 18 of the 20 PDX models. Overall, we are exceptionally pleased with the RAS wild-type preclinical data presented at ACR, as it emphasizes that onbamster tip has broad spectrum activity in MCRC, independent of RAS mutational status. This provides sound rationale for us to consider future clinical trials in rats and wild types. Ahem.

Gilmartin group: In combination on <unk>, and Cetuximab induced tumor stasis of regression in 90% or 18 of the 20 Pdx models.

Gilmartin group: Overall, we are exceptionally pleased with our <unk> preclinical data presented at ACR as I'd emphasize that our advances have have broad spectrum activity and MTR see independent of Ras mutation set.

Gilmartin group: This provides sound rationale for us to consider future clinical trials, and Ras wild type and CFC.

Gilmartin group: I now would like to share the data we presented at ACR demonstrated on Bachelor chips anti tumor activity across multiple tumor types outside of it.

Mark Erlander: I now would like to share the data we presented at AACR demonstrating VASHR-TiB's anti-tumor activity across multiple tumor types outside of AACR. If you recall, last September, we shared clinical data from our investigator-initiated trial in extensive-stage small-cell lung cancer, where Vancer 2 as a single agent demonstrated a confirmed partial response to 50% shrinkage of the patient's tumor among the first seven While we were impressed by ADVANCER-TIB's stimulation activity, we believe a combination strategy would be the optimal approach to treating this aggressive disease.

Gilmartin group: If you recall last September we shared clinical data from our investigator initiated trial in extensive stage small cell lung cancer. We're on Vantiv as a single agent demonstrated a confirmed partial response, the 50% shrinkage a patients tumor along among the first seven patients treated on the trial.

Gilmartin group: While we were impressed by advantage of single agent activity. We believe our combination strategy would be the optimal approach to treating this aggressive disease at that time, we disclosed at our clinical path forward in small cell lung cancer will be the combination strategy of <unk> and Paclitaxel, which.

Mark Erlander: At that time, we disclosed that our clinical path forward in small cell lung cancer would be a combination strategy of ADVANCER-TIB and Paclitaxin, which is one of the standards of care for second-line small cell lung cancer. At ACAACR, we presented preclinical evidence that supports this clinical plan. In vitro, the combination of Onvancertib plus Paclitaxel synergistically inhibited tumor proliferation in cell lines for small cell lung cancer. In vivo, the combination was well-tolerated and highly effective in cisplatin-sensitive and resistant PDX models for small cell lung cancer.

Gilmartin group: Is one of the standards of care for second line small cell lung cancer.

Gilmartin group: At AC ACR, we presented preclinical evidence that supports this clinical plan.

Gilmartin group: In vitro the combination of our that's our typical paclitaxel synergistically inhibited tumor proliferation and cell lines for small cell lung cancer in vivo the combination was well tolerated and highly effective.

Gilmartin group: Cisplatin sensitive and resistant pdx models of small cell lung cancer.

Mark Erlander: These findings support the scientific rationale for a planned investigator-initiated trial combining ombamcetib with paclitaxin, promising treatment strategies for extensive-stage, small-cell lung cancer patients. Our final poster, presented at AACR, evaluated the combination of undancored TIF plus carboplatin or gemcitabine in high-grade serious ovarian cancer, where both of these agents are standard of care. In vitro, Onvanstratib was synergistic in combination with carboplatin, as well as with genocidabine in an ovarian cell line. In vivo, both combinations demonstrated antitumor activity in platinum-resistant ovarian cancer PDX models and were well tolerated. Overall, we believe that these data support the potential of Onvanstratib to improve standard of care for platinum-resistant ovarian cancer patients.

Gilmartin group: These findings support the scientific rationale for a planned investigator initiated trial, combining <unk> with paclitaxel as a promising treatment strategy for extensive stage small cell lung cancer patients.

Gilmartin group: Our final poster presented at ACR evaluated the combination of <unk>, plus Carboplatin Gemcitabine and high grade serious ovarian cancer models, where both of these agents are standard of care.

Gilmartin group: In vitro the answer to the synergistic in combination with Carboplatin as well as with Gen side of the in an ovarian seller in vivo both combination demonstrated anti tumor activity in platinum resistant ovarian cancer Pdx models and were well tolerated overall, we believe that these data support.

Gilmartin group: What the potential of unanswered chips improve standard of care treatments for platinum resistant ovarian cancer patients at.

Mark Erlander: At the moment, we are still determining our path forward in this indication. So, in summary, the data we presented at AACR this year provided strong scientific rationale for the clinical development of Onbanser tip across multiple tumor types and various combinations, and our RAS mutated MCRC data provided further validation of our LEAD program and our ongoing Cardiff 004 clinical trial. Now turning to our second agenda item, CARDIFF-004 is our ongoing phase two trial evaluating the first blind patients with RAS mutated. On bandage, it is being added to standard care, current standard care, which is either Fulfury plus Bev or Fulfox.

At the moment, we are still determining our path forward in this indication.

Gilmartin group: So in summary, the data we presented at ACR. This year provided strong scientific rationale for the clinical development of <unk> across multiple tumor types and various combinations.

Gilmartin group: And our RAF mutated <unk> data provided further validation of our lead program in our ongoing Carter zero zero for clinical trial.

Gilmartin group: Now turning to our second agenda item <unk> is our ongoing phase II trial evaluating <unk>.

Mark Erlander: <unk> patients with Ras mutated in CRC.

Gilmartin group: <unk> is being added to the standard care current standard of care, which is either full carry plus bev or full Fox plus that we plan to enroll a total of 90 patients who will be randomized to receive either 20 mid <unk> plus standard of care <unk> plus standard of care or standard of care.

Mark Erlander: We plan to enroll a total of 90 patients who will be randomized to receive either 20 MIGs of undamaged tibia plus standard of care, 30 MIGs of undamaged tibia plus standard of care, or standard of care alone. We are working closely with our partner, Pfizer-Ignite, who is conducting the clinical execution of the trial. And we are highly confident in Pfizer's ability to operationally execute, given their track record of success. Currently, we have 24 activated clinical trial sites.

Gilmartin group: Don.

Mark Erlander: We are working closely with our partner Pfizer is not who is conducting the clinical execution of the trial and we are highly confident in <unk> ability to operationally execute given their track record of success. Currently we have 24 activated clinical trial sites.

Gilmartin group: In August of 2023, when we decided to move forward with the card of Georgia Port fire, we forecasted that we would be able to share additional data from the trial into Q2, Q2, Q2, Q3 2024 timeframe as.

Mark Erlander: In August of 2023, when we decided to move forward with the Cardiff-004 trial, we forecasted that we would be able to share initial data from the trial in the Q2-Q3-2024 timeframe. As of today, and based on the actual enrollment trends at our activated sites for the past few months, our expectation for the timing of an initial readout is now in the second half of this year, or Q3-Q4. I want to make it clear that this timing for the readout is solely based on the pace of enrollment.

Gilmartin group: As of today and based on the actual enrollment trends at our activated sites for the past few months our expectation for the timing of an initial readout is now in the second half of this year or Q3 Q4.

Gilmartin group: Want to make it clear that this timing for the readout is solely based on the pace of enrollment.

Mark Erlander: We, together with Pfizer-Ignite, feel confident in our ongoing site activation and enrollment efforts, and we believe that we have all the right resources to meet this timeline. We anticipate this initial top-line data release will include objective response rates for approximately half of the 90 patients we expect to enroll in the trial. Now I would like to turn the call over to Jamie to discuss our third agenda item, our first quarter 2024 financial update.

Gilmartin group: We together with Pfizer ignite feel confident in our ongoing site activation and enrollment efforts and we believe that we have all the requisite resources to meet this timing.

Gilmartin group: We anticipate this initial top line data release will include objective response rate for approximately half of the 90 patients we expect to enroll in the trial.

Gilmartin group: Now I would like to turn the call over to Jamie to discuss our third agenda item, our first quarter 2020 for financial update.

James E. Levine: Thank you Mark.

James E. Levine: Earlier today, we issued a press release summarizing our financial results for the first quarter ending March 31, 2024. You can also find additional information in our Form 10-Q for the first quarter filed with the SEC earlier today. Turning to our balance sheet, cash and short-term investments as of March 31, 2024 totaled $67.2 million, and our cash used in operating activities was $7.7 million in Q1 2024. We believe that our current cash resources provide us with cash runway into the third quarter of 2025, which is well beyond the updated timing for the initial readout from the Cardiff 004 trial marked just, With that, I'll turn the call back over to

Jamie: Earlier today, we issued a press release summarizing our financial results for the first quarter ending March 31, 2024, you can also find additional information in our Form 10-Q for the first quarter filed with the SEC earlier today.

James E. Levine: Turning to our balance sheet cash and short term investments as of March 31, 2024 totaled $67 $2 million and our cash used in operating activities was $7 7 million in Q1 2024.

Gilmartin group: We believe that our current cash resources provide us with cash runway into the third quarter of 2025, which is well beyond the updated timing for the initial readout from the Cardiff 004 trial, Mark just discussed.

Gilmartin group: With that I'll turn the call back over to Mark. Thank you Jami, let me close the call by emphasizing our conviction in our clinical development strategy to add on the answer to the standard of care in first line Ras mutated NCIC.

Mark Erlander: Thank you, Jamie. Let me close the call by emphasizing our conviction in our clinical development strategy to add Vancertain to standard care in first-line RAS mutations. We followed the data that was available at the time, and with the Ensembl clinical data and the AACR data announced this quarter, our confidence continues to grow. And that brings us to where we are today, in our ongoing CARDIC-004 trial for the treatment of first-line RAS-mutated MCRC. Overall, we believe that the initial data readout of CARDIFF004 has the potential to be an important value inflection point for Cardiff Oncology and for the nearly 50,000 patients diagnosed with RAS-mutated MCRC each year.

Mark: We followed the data that was available at the time and with the ensemble clinical data and the ACR data announced this quarter our confidence continues to grow.

Mark: And that brings us to where we are today.

Gilmartin group: Our ongoing <unk> trial for the treatment of first line Ras mutated and CRC overall, we believe that the initial data readout of Carter <unk> four has the potential to be an important value inflection point for Cardiff oncology and for the nearly 50000 patients diagnosed.

Operator: We look forward to sharing an update on the trial later this year. With that, I will now open the call up for questions. Operator? Thank you so much. And, as a reminder, press star 1-1 to get in the queue and wait for your name to be announced. One moment while we compile the Q&A roster.

Gilmartin group: With Ras mutated NCIC each year.

Gilmartin group: We look forward to sharing an update on the trial later this year.

Speaker Change: With that I will now open the call up for questions. Operator. Thank you so much and as a reminder, crestar one one to get in the queue and wait for your name to be announced.

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

Operator: One moment for our first question comes from Marc Frahm with TD Cowen. Please proceed.

Operator: One moment for our first question. It comes from Mark Frahm with TD Cowan. Please proceed.

Mark Erlander: Thanks for taking my questions. Let me just start off on the tweak to guidance on when the interim data might become available. Can you just maybe clarify how much of the small push-out was really, you know, kind of the enrollment pace once sites are open versus maybe just some delays getting the sites up and up and running as quickly as you'd hoped? Well, yeah, let me just thank you, Mark, for the question.

Marc Alan Frahm: Hi, Thanks for taking my questions, maybe just start off on the okay. The tweak to guidance.

Marc Alan Frahm: The guidance on the on when the interim data might be come available can you just maybe clarify how much of the small pushout, what's really.

Marc Alan Frahm: Okay. The enrollment pace one sites are open versus maybe just some delays getting the sites up and up and running as quickly as you had hoped.

Speaker Change: Well, yes, let me thanks, Marc for the question and let me just step back for a minute and just talk about the cartridges are poor trial.

Mark Erlander: And let me just step back for a minute and just talk about the CARD-004 trial. Over the last month or so, Dr. Fairooz Kabbinavar, our chief medical officer, and I have been going across the country and visiting with the principal investors that are participating in our trial. And Fairooz has actually been taking them through the previous data, the Phase 1B2, and the Ensembl data. And what I would say to you, universally, is that there is a high amount of enthusiasm among all of the principal investigators we have met.

Mark Erlander: And the reason for that is not only because of the actual data that they're seeing building up to the trial that they're participating in now, but also because the Oncomancer tip does provide a novel, new option for first-line therapy in a setting where, as you know, there have been no new therapies for 20 years. Also, one of the key things that makes them enthusiastic is the actual design of the trial because we're adding on to that which we're building it onto current standard care and not replacing it. And finally, also, there are no competing trials for closed-line vascular.

Over the last month or so Dr. Bruce <unk>, our Chief Medical Officer.

Marc Alan Frahm: <unk> have been going across the country and visiting with the principal investigators.

Mark Erlander: That are participating in our trial and peruse has actually been taking them through the previous data on the phase will be to and the ensemble data.

Marc Alan Frahm: And what I would say to you universally is that there is a high amount of enthusiasm.

Marc Alan Frahm: All of the principal investigators we have met and the reason for that is not only because of the of the actual data that we're seeing building up to the trial that are participating in now but also that.

<unk> does provide a novel new option.

Mark Erlander: For first lines in the first line setting where as you know there have been no new therapies for 20 years.

Mark Erlander: Also one of the key things that may.

Mark Erlander: I'm enthusiastic is the actual design of the trial because we are adding on beverage. We're building it on to current standard of care and not replacing Jack here and finally also there are no competing trials for a post line Ras mutated in CRC. So.

Mark Erlander: As I was saying earlier in the call, when we made the decision in the summer of 2023 to basically start Cardiff-004, that's when we then announced in August of 2023, prior to the trial starting, the forecast to share data in the Q2-Q3 timeframe of 2024. Now that we've got several months of enrollment and the pace of enrollment, we are able to make a more accurate projection of the data share, and that is more in the future.

Gilmartin group: As you know as I was saying earlier in the call.

Mark Erlander: We started.

Mark Erlander: When we made the decision this summer.

Gilmartin group: Two of summer of 'twenty three to basically start card observes over four that's when we.

Mark Erlander: Then announced in August of 'twenty three prior to the trial started.

Gilmartin group: The forecast to share data in the Q2 Q3 timeframe of 2024.

Gilmartin group: Now now that we've got several months of the enrollment and the pace of enrollment.

Mark Erlander: We are able to now make a more accurate projection of the data share.

Gilmartin group: That is more on the Q3 Q4.

Mark Erlander: And so I think one thing, the last thing I'd say, Mark, is that, you know, why are we so confident of this timing? It's really because we are leveraging Pfizer's resources, Pfizer-Ignite's resources, their techniques, and their capabilities in multiple areas around the execution of this trial, and we are very confident of their efficiency. Great, that's helpful. And then maybe just as we get to that data, can you kind of review some of the scenario planning that you and the team are kind of going through in terms of the data, you know, is, I know it's not a formal statistical analysis there, but is there a scenario where it could get shut down, either more kind of from a futility perspective, or also on the other end of the spectrum, make you want to Yeah, I mean, I think so.

Gilmartin group: And so I think one thing last thing I'd say markets that.

Mark Erlander: Why are we so confident of this timing that's really because we are leveraging pfizer's resources, Pfizer ignites resources their techniques and their capabilities in multiple areas.

Mark Erlander: The.

The execution of this trial and we are very confident of their ability to execute.

Mark Erlander: Okay, Great that's helpful and then.

Gilmartin group: Maybe just as we get to that data.

Speaker Change: Reviewing some of the scenario planning that.

Speaker Change: And the team are going through in terms of the data.

Mark Erlander: I know, it's not a formal statistical analysis, there, but is there a scenario where.

Mark Erlander: It could get shut down either more kind of from a utility perspective or also on the other end of the spectrum.

Speaker Change: Mick you want to kind of accelerate plans to open up five EBIT, even faster and not have to wait for all 90 patients.

Mark Erlander: Yeah, I mean, right now, of course, what we are saying is that we will be looking to share data, initial data, in the Q3, Q4 time frame, and we should have approximately half the patients of the trial, approximately that, with at least one post-baseline scan. I mean, one thing I would say about that timing, and it's a great question, Mark, is that the 004, from the FDA's point of view, is really a dose confirmation trial with Project Optimist, and so the faster we can get to the FDA with a dose, of course, the better off we are, and the better off we are as far as our timelines for going into our registration.

Mick: Yes, I mean I think.

Speaker Change: Right now of course, what we are.

Mark Erlander: What we're saying is that we will be looking to share data initial data in the Q3 Q4 timeframe, we should have approximately.

Mark Erlander: Half the half the patients of the trial approximately that.

Mick: With at least one post baseline scan I mean.

Mick: One thing I would say about that time and it's a good it's a great question Marc is that.

Mark Erlander: 004 from the Fda's point of view is really a dose confirmation trial with project Optimists and so the faster we can get to the FDA.

Mark Erlander: A dose of course, the better off we are in better off we are as far as our timelines is going into a registrational trial.

Speaker Change: Okay. Thanks.

Operator: Thank you. One moment for our next question, please. And it comes from the line between Joe Catanzaro and Piper Sandler. Please proceed.

Speaker Change: Thank you one moment for our next question. Please.

Mark Erlander: And it comes from the line of Joe Catanzaro with Piper Sandler. Please proceed.

Joseph Michael Catanzaro: Everybody. Thanks for taking my questions here.

Joseph Michael Catanzaro: Hey, everybody. Thanks for taking my questions here. It may be the first one with the slight push in... the initial readout from OO4. I'm wondering if there's a possibility of maybe seeing another cut of the ensemble cohort before then, just getting longer follow-up and a better sense of the durability of responses and how that's shaking out between, you know, the arms of the trial, the BEV-NAEVE BEV experience, so any thoughts there would be helpful, and I might

Joseph Michael Catanzaro: Maybe first one with the slight push in.

Joseph Michael Catanzaro: The initial readout from all four of them.

Joseph Michael Catanzaro: I'm wondering if there is a possibility of maybe seeing another cut.

Joseph Michael Catanzaro: Sample cohort.

Joseph Michael Catanzaro: Before them just before then just getting longer follow up of a better sense of the durability of responses and how thats shaking out between.

Joseph Michael Catanzaro: The arms of the trial.

Speaker Change: His experience so any thoughts there would be helpful.

Mark Erlander: Yeah, thanks, Joseph, for the question. I mean, as we sit here today, you know, we did announce the data on February 29th for the Ensembl trial, and we felt that that was a very robust data set that propelled us with even greater confidence into our 004. But, as we sit here now, we don't have plans to have a continued follow-up to the Ensembl trial.

Speaker Change: Yes, Thanks, Jeff for the question I mean, as we sit here today, we did announce the the data on February 29th or the ensemble trial, and and we felt that that was a very robust dataset that propelled us with even greater confidence into our 004.

Mark Erlander: As we sit here now we don't have plans to have a continued follow up of the ensemble data.

Mark Erlander: Okay.

Joseph Michael Catanzaro: Okay. Thanks.

Joseph: Okay. Thanks, and then maybe my follow up is on the preclinical work at ACR in the rest of wild type CRC scenario.

Mark Erlander: And then maybe my follow-up will be on the preclinical work at AACR on the rat-to-wild type CRC scenario. I recall years ago the synthetic lethality idea of PLK1 inhibition in the context of a mutant rat. It seems like you're sort of thinking outside of that, and you mentioned potentially exploring it. Whether there's an opportunity to explore that clinically and think about that population of patients within the context of a potential future. Pivotal Frontline Trial

Mark Erlander: Alright.

Speaker Change: I recall you are back.

Mark Erlander: The synthetic lethality idea of PL K, one inhibition in the context of mutant.

Mark Erlander: It seems like Youre sort of.

Mark Erlander: Thinking out side of that and you mentioned potentially exploring it maybe you could just elaborate whether there is opportunity.

Mark Erlander: Explore that clinically and think about that population of patients within the context of the.

Mark Erlander: Potential future.

Mark Erlander: Pivotal frontline trial.

Mark Erlander: Yeah, great question, Joe. I'd say, you know, first of all, when you look at rat wild type and rat mutant tumors and colorectal, those are very different beasts, very different animals in the sense of biology. And so, you know, as you know, we did, we have shown synthetic lethality in the RAS mutant background. But in RAS wild type, I think it's a different biology.

Speaker Change: Yes, Great question, Joe I'd say first of all.

Speaker Change: The.

Mark Erlander: When you look at.

Mark Erlander: Ras Wild type in Ras mutant tumors and colorectal those are very different these are very different animals in the sense of the biology and so.

Speaker Change: As you know we did we have shown synthetic fatality in the Ras mutant.

Mark Erlander: Our background.

Mark Erlander: In Ras Wild type I think it's a different biology, and I think that we are seeing the very interesting.

Joseph Michael Catanzaro: And I think that we are seeing a very interesting finding where we are combining cetuximab. And so I think, as we sit here today, we are evaluating what kind of trial design that would be in the wild type setting. But we haven't, you know, we have not made any moves yet in that area. Our focus, as we sit here today, continues to be 004 and getting the data toward registration.

Speaker Change: Finding where we are combining with cetuximab and so I think as we sit here today.

Joseph Michael Catanzaro: We are evaluating what kind of trial design that would be in the wild type setting, but we haven't we have not made any move yet in that area. Our focus as we sit here today continues to be Jos therefore, and getting getting the data toward the Registrational trial.

Speaker Change: Okay got it that's all helpful. Thanks for taking my question absolutely. Thanks, Joe Thank you.

Operator: Okay, got it. That's all helpful. Thanks for taking my question. You know, I have to...

Andy Xie: Thanks, Joe. Thank you. One moment for our next question, and it comes from Andy Xie with William Blair. Please proceed.

Speaker Change: One moment for our next question.

And it comes from Andy here with William Blair. Please proceed.

Mark Erlander: Great, thanks for taking our questions. A couple of quick ones from us, if you don't mind. So, in terms of clinical sites, I believe, Mark, you said 24 sites right now. I believe it was 20 before and is your end goal being 30 total by the end of enrollment completion.

Andy Xie: Great. Thanks for taking our questions.

Speaker Change: Couple of quick ones from US if you don't mind. So there was a clinical site.

Mark Erlander: I believe.

Mark Erlander: You said 24 sites right now I believe it was.

Mark Erlander: <unk> before and is your end goal being B 30 total by the end of the enrollment completion.

Andy Xie: Yeah, thanks Annie for that question. So, you're right, as of today, we have 24, and our goal, actually, in working with Pfizer-Ignite is to activate 35 sites. And we are also looking at some additional sites. But one of the things to keep in mind with this is that this is a very dynamic process in the sense that we continue to evaluate sites, and if the site is not performing, then that site could be replaced by another site. So, you know, the number is not always static. It's really more dynamic as we go through this trial and continue to act.

Mark Erlander: Yeah. Thanks, Thanks for that question so.

Mark Erlander: Okay, that's helpful. Thank you.

Mark Erlander: You are right as of today, we have 24 and our our goal actually in working with Pfizer ignite is to activate 35 sites and we are also looking at some additional sites, but one of the things to keep in mind that with it is just a very dynamic process.

Mark Erlander: In a sense that.

Mark Erlander: We continue to evaluate sites and if the site.

Mark Erlander: Is not performing then that sites will be replaced with another site. So the.

Mark Erlander: The number is not always static.

Mark Erlander: To be more dynamic as we.

Mark Erlander: Go through this trial and continue to activate sites.

Mark Erlander: Okay.

Andy Xie: And just kind of follow up on Mark's question before, you mentioned about Project Optimist, two doses in the 004 study. Is it conceivable to bring two doses in the pivotal study? Is that a potential scenario? And I guess, you know, from an FDA perspective, beyond kind of confirmation of safety and efficacy, what else are they looking at before giving you the okay to start a pivotal study?

Speaker Change: That's helpful. Thank you and just kind of follow up on Mark's question before.

Andy Xie: You mentioned about project Optimists, two doses and as usual for steady.

Andy Xie: Is it is it conceivable to bring two doses in the pivotal study is that a potential scenario and I guess from a.

Andy Xie: FDA perspective beyond kind of come for confirmation as safety efficacy.

Andy Xie: Are they looking at before giving you the okay to start a pivotal study.

Speaker Change: Right. Thanks for the question.

Mark Erlander: Right. Thanks for the question. And just to answer those questions kind of literally, first off, we don't expect to go into the registration trial. We plan to have a single post. And you're right, what the FDA looks for is really, is there a difference between the efficacy of the two doses, and is there a difference in safety? Both those things we will be continuing to evaluate, not only using our existing data but also, obviously, the 004 data.

Speaker Change: Just to answer the question is kind of literally.

Mark Erlander: First off we don't expect to go into the Registrational trial with two doses.

Mark Erlander: We plan to have any single awards.

Mark Erlander: And Youre right, what's the FDA looks for.

Mark Erlander: Is really is there a difference between the efficacy between the two doses and is there a difference in the safety.

Mark Erlander: Both of those things you will be continuing to evaluate not only using our our existing data, but also the deals obviously, the Georgia for data and like I said to Mark.

Mark Erlander: And like I said to Mark, our goal, you know, the gate to the registrational trial is this confirmation of dose with the FDA. And so, of course, we are very focused on getting that as soon as possible.

Mark Erlander: Our goal.

Mark Erlander: The gate to the Registrational trial is this.

Mark Erlander: Confirmation of dose with the FDA. So of course, we are very focused on getting that as soon as possible.

Andy Xie: And maybe my last question has to do with catalyst events. So, Jamie, you talked about Q3 2025 being the cash runway, you know, perhaps, can you give us maybe a big picture view? Obviously, the 004 study happening in the second half of this year. But any other potential data readouts that you can expect in the first three quarters of 2025 that could allow us to better appreciate the clinical activity of ombansertib

Speaker Change: Great and then maybe my last question has to do with.

Mark Erlander: Catalyst events.

Andy Xie: So Jamie you talked about Q3 2025 being the cash runway.

Andy Xie: Perhaps can you give us maybe a big picture view, obviously <unk> steady happening in the second half of this year.

Andy Xie: Any other.

Andy Xie: <unk> data Readouts that you can expect in the first three quarters of 2025 that could.

Andy Xie: Allow us to better appreciate the clinical activity of them answered yet.

Mark Erlander: It's a great question. We are not prepared at this point to set dates for some of the investigator-initiated trials that we do actually have ongoing right now. Those could potentially be, but we're just not prepared to put out in the public, okay, this is the time that we would announce data on those trials. But clearly, we are looking at those as well as we continue to keep a laser focused on the

Jamie: Great question, we're not prepared at this point to set dates on.

Andy Xie: Got it. I understand. All right. Thanks so much for answering all of our questions.

Mark Erlander: Some of the investigator initiated trials that we do actually haven't gone going right now.

Operator: And I will conclude the Q&A session as I see no further questions and hand them back to Mark Erlander. Thank you.

Mark Erlander: Those could be potentially but we're just not prepared.

Andy Xie: To set put out in the public. Okay. This is the time that we announced data on those trials, but clearly we are looking at those as well as we continue to keep our laser focused on the zero to report as well.

Speaker Change: Got it I understand alright, thanks, so much for answering all of our questions.

Mark Erlander: Thank you Andy.

Operator: Thank you and I will conclude the Q&A session I see no further questions and have them back to Mark Erlander. Thank you.

Mark Erlander: Thank you, Operator, and this concludes our conference call. Thank you once again, everyone, for joining us this afternoon. Have a good day. Thank you. You may all disconnect. ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? Thank you for watching!

Mark Erlander: Thank you operator, and this concludes our conference call. Thank you once again, everyone for joining US. This afternoon have a good day.

Operator: Thank you. You may all disconnect. In the name of the Father, and of the Son, and of the Holy Spirit. Amen.

Mark Erlander: Thank you you may all disconnect.

Operator: [music].

Operator: Yes.

Operator: [music].

Operator: [inaudible] ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? www.cdc.gc.ca ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ? ? ? ? ? ? ? ? ? ? ? ? Welcome to the Cardiff Oncology first quarter 2024 financial results and business update conference call. At this time all participants are in a listen-only mode.

Operator: 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 11 on your telephone, and you will hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Kiki Patel of Gilmartin Group. Please go ahead.

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. 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 unadvanced 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: [music].

Mark Erlander: Thank you, Kiki, and good afternoon, everyone, and thank you for joining our conference call for the first quarter of 2024 Business Update. It was less than a year ago that we announced that our clinical development plan for ADVANTAGES would focus on the first-line treatment of RAS-mutated metastatic colorectal cancer, or MCRC. The data we shared last August supported this, and our focus on first-line MCRC addresses a large patient population, almost 50,000 new patients a year in the United States for whom there have been no new therapies approved in 2012. In the first quarter of 2024, three data sets added to the body of evidence supporting our first-line focus strategy.

Mark Erlander: [music].

Mark Erlander: The first was the ENSEMBLE data, which served as an independent and randomized data set that replicated the efficacy signals in VEV-naive patients observed in our Phase 1b2 trial. Second, were five posters presented at the annual meeting of the American Association for Cancer Research, or AACR. And finally, was the publication of data in the peer-reviewed journal, Clinical Cancer Research, from the Phase 1b portion of our Phase 1b2 KWACS-mutated MCRC trial. I want to emphasize our conclusion that the collective data released in Q1 strongly supports our finding that adding on banter... Standard of Care, O'Berry, and Bevis and Demeb, which I will refer to as BEV, has significantly, has made Now, during today's call, we have three topics to cover.

Gilmartin group: And your telephone and you will hear an automated message advising your hand. This waste. Please be advised that today's conference is being recorded I would now like to turn the conference over to keep the Chow of Gilmartin Group. Please go ahead.

Mark Erlander: First, I will provide a summary of the promising data we presented last month at AACR. Next, we will discuss our lead program in MCRC and provide updates on our ongoing Cardiff 004 trial. And finally, we'll talk about our financial position that we disclosed today in our Form 10-Q. So let's begin.

Mark Erlander: Last month, the American Association for Cancer Research held its 2024 annual meeting in San Diego, in which Cardiff Oncology presented a total of five post-op studies, all of which are available on our website. One poster describes the design of our ongoing study for Cardiff 0045, and a second poster presented data that supports our first-line strategy in MCRC by providing new translational data from our Phase 1b2 trial and second-line KRAS Three additional posters shared promising preclinical data in other cancer indications, including RAS wild-type MCRC, small-cell lung cancer, and ovarian cancer, demonstrating the broad opportunities we see around the answer. I would like to highlight some of the important data we presented in the poster on our LEAD program and RAS mutated cells.

Speaker Change: Thank you operator, joining us on the call today requires oncology, our chief Executive officer, Mark or lender and Chief Financial Officer, Jamie Levine.

Mark Erlander: In this poster, we presented both clinical data from the Phase 1P2 trial and subsequent data from preclinical studies that form the basis of the scientific rationale for our clinical findings. We also demonstrated that BAB-90 patients within this trial had a higher objective response rate and longer progression. The additional pre-clinical data disclosed at AACR provides further evidence that onbansersib and BEV have their pharmacological effects at two different nodes of the hypoxia pathway. We have awesome hope that on vaccine-to-the-dead work in a synergistic manner, giving a one-two punch to the tumor.

Mark Erlander: During this conference call management will make forward looking statements, including without limitation statements related to guidance.

Mark Erlander: It's finding a theater readouts for on vantage and clinical trials.

Mark Erlander: 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.

Mark Erlander: Factors that could cause results to be different from these statements include factors. The company described in the section titled Risk factors in our annual report on Form 10-K filed with the SEC for the year ended December 31 2023.

Mark Erlander: <unk> undertakes no duty or obligation to update any forward looking statements.

Mark Erlander: As a result of new information future events or changes in its expectations.

Mark Erlander: With that I turn the call over to Chief Executive Officer, Mark or later, Mark well. Thank you Pete.

Speaker Change: And good afternoon, everyone and thank you for joining our conference call for the first quarter of 2020 for business update.

Mark Erlander: It was less than a year ago that we announced that our clinical development platform of attitude with focus on the first slide three of <unk>.

Mark Erlander: Last mutated metastatic colorectal cancer or <unk>.

Mark Erlander: Data, we shared last August supported us.

Mark Erlander: And our focus on first half first line <unk> addresses a large patient population almost 50000, new patients a year in the United States for whom there have been no new therapies approved in 20 years.

Mark Erlander: Three dataset added to the body of evidence supporting our ports line focus strategy.

Mark Erlander: First was the ensemble data, which served as an independent and randomized dataset that replicated the efficacy signal and Bev naive patients observed in our phase <unk> trial.

Mark Erlander: Second was our five posters presented at the annual meeting of the American Association for cancer research or <unk>.

Mark Erlander: I want to emphasize our conclusion that the collective data released in Q1 strongly support our findings that adding <unk> to standard of care or theory, and Bevacizumab, which I will refer to as Beth has significantly has significant efficacy and RAF mutated MGIC.

Mark Erlander: Patients that have had no prior treatment.

Speaker Change: So let's begin.

Mark Erlander: Our hypothesis was further strengthened by our preclinical in vivo data and three KRAS mutant MCRC xenograft models. Combination treatment with Onvancer TIF plus BED resulted in significantly superior anti-tumor activity compared to monotherapy with either agent. And importantly, the combination treatment also resulted in a greater decrease in tumor vascularization compared to either agent. This finding provides rationale for further exploration of the combination of ondansetib and BEV in additional indications where BEV is FDA-approved.

Mark Erlander: Collectively, the clinical and preclinical data presented at AACR in RAS-mutated second-line MCO2, provide further validation of our ongoing Cardiff-004 trial. We believe vancitin will have a significant impact in the first line setting, given that all patients are deaf-nave.

Mark Erlander: Now, let's move on to our additional posters presented at AACR in therapeutic areas outside of our core focus of graft-mutated MCRC. Today, most of the data we have generated in MCRC has been in RAS-mutated patients, and we are often asked if our therapy could work for patients who do not have a RAS mutation. At ACR, we shared encouraging preclinical data in RAS wild-type MCRC, meaning these models were derived from patients who did not have a RAS mutation.

Mark Erlander: Our preclinical study in RAS wild-type MCRC patient-derived VenoGraft or PDX models aimed to assess the efficacy of ondansetib as monotherapy and in combination with the EGFR inhibitor tetuximab, which is the standard of care for RAS wild-type MCRC patients. We evaluated models that were both sensitive to Situximab and resistant to Situximab. In summary, Onvancitib displayed robust anti-tumor activity as a single agent in Cetuximab-sensitive and resistant PDX models. As for combination therapy, efficacy was enhanced when Onvancitib and Cetuximab were combined compared to monotherapy of either agent alone.

Mark Erlander: In combination, Onbanser-Tibb and Cetuximab induced tumor stasis or regression in 90% or 18 of the 20 PDX models. Overall, we are exceptionally pleased with the RAS wild-type preclinical data presented at ACR, as it emphasizes that Onbansha tips have broad spectrum activity in MCRC, independent of RAS mutational status. This provides sound rationale for us to consider future clinical trials in rats and wild types. Ahem.

Mark Erlander: I now would like to share the data we presented at AACR demonstrating VASHR-TiB's anti-tumor activity across multiple tumor types outside of AACR. If you recall, last September, we shared clinical data from our investigator-initiated trial in extensive-stage small-cell lung cancer, where patients were on Vancer 2 as a single agent, demonstrated a confirmed partial response to 50% shrinkage of the patient's tumor While we were impressed by Onvancertib's single-agent activity, we believe a combination strategy would be the optimal approach to treating this aggressive disease.

Mark Erlander: At that time, we disclosed that our clinical path forward in small-cell lung cancer would be a combination strategy of Onvancertib and Paclitaxel, which is one of the standards of care for second-line small cell lung cancer. At AACR, we present preclinical evidence that supports this clinical plan. In vitro, the combination of Onbanser tip plus Paclitaxel synergistically inhibited tumor proliferation in cell lines In vivo, the combination was well-tolerated and highly effective in cisplatin-sensitive and resistant PDX models for small cell lung cancer.

Mark Erlander: These findings support the scientific rationale for a planned, investigator-initiated trial combining on-bamster tips with paclitaxin, promising treatment strategies for extensive-stage, small-cell lung cancer patients. Our final poster, presented at ACR, evaluated the combination of Umbantra TIP plus carboplatin or gemcitabine in high-grade serious ovarian cancer, where both of these agents are standard of care. In vitro, OnvantraTib was synergistic in combination with carboplatin, as well as with genocidabine in an ovarian cell line. In vivo, both combinations demonstrated antitumor activity in platinum-resistant ovarian cancer PDX models and were well-tolerated. Overall, we believe that these data support the potential of OnvantraTib to improve standard of care for platelet-resistant ovarian cancer patients.

Mark Erlander: These findings support the scientific rationale for a planned investigator initiated trial, combining <unk> with paclitaxel as a promising treatment strategy.

Mark Erlander: At some stage small cell lung cancer pitch.

Mark Erlander: Our final poster presented at ACR evaluated the combination of <unk>, plus Carboplatin Gemcitabine and high grade serious ovarian cancer models, where both of these agents are standard of care in vitro evaporative with synergistic in combination with Carboplatin as well as the.

Mark Erlander: Gen side of the in an ovarian seller in vivo both combination demonstrated anti tumor activity in platinum resistant ovarian cancer Pdx models and were well tolerated overall, we believe that these data support the potential of a matching chips improve standard of care treatments for platinum resistant ovarian.

Mark Erlander: <unk> cancer patients at the moment, we are still determining our path forward in this indication.

Mark Erlander: At the moment, we are still determining our path forward in this indication. So, in summary, the data we presented at AACR this year provided strong scientific rationale for the clinical development of Onvancertib across multiple tumor types and various combinations, and our RAS-mutated MCRC data provided further validation of our LEAD program and our ongoing CARDIS-004 clinical trial. Now turning to our second agenda item, CARDF-004 is our ongoing phase two trial evaluating first-line patients with raft mutated. Vastatib is being added to the current standard of care, which is either Full Theory plus BEV or Full FOX.

Mark Erlander: So in summary, the data we presented at ACR. This year provided strong scientific rationale for the clinical development of <unk> across multiple tumor types and various combinations and our RAF mutated <unk> data provided further validation of our lead program in our ongoing Carter 004.

Mark Erlander: Clinical trial.

Mark Erlander: Now turning to our second agenda item <unk> is our ongoing phase II trial evaluating <unk>.

Mark Erlander: <unk> patients with Ras mutated and CRC.

Mark Erlander: <unk> is being added to the standard care current Derek Kerr, which is either full theory, plus Bev all Fox plus that we plan to enroll a total of 90 patients who will be randomized to receive either 20 mix of <unk> plus standard of care. They already made the von <unk> plus standard of care or standard of care.

Mark Erlander: We plan to enroll a total of 90 patients who will be randomized to receive either 20 MIGs of undancored tip plus standard care, 30 MIGs of undancored tip plus standard care, or standard care alone. We are working closely with our partner, Pfizer-Ignite, who is conducting the clinical execution of the trial. And we are highly confident in Pfizer's ability to operationally execute, given their track record of success. Currently, we have 24 activated clinical trial sites.

Mark Erlander: Don.

James E. Levine: Thank you, Mark. Earlier today, we issued a press release summarizing our financial results for the first quarter ending March 31, 2024. You can also find additional information in our Form 10-Q for the first quarter filed with the SEC earlier today. Turning to our balance sheet, cash and short-term investments as of March 31, 2024 totaled $67.2 million, and our cash used in operating activities was $7.7 million in Q1 2024. We believe that our current cash resources provide us with cash runway into the third quarter of 2025, which is well beyond the updated timing for the initial readout from the Cardiff 004 trial marked just, With that, I'll turn the call back over to

Mark Erlander: Thank you, Jamie. Let me close the call by emphasizing our conviction in our clinical development strategy to add Vancerton to the standard of care in first-line RAS mutations. We followed the data that was available at the time, and with the Ensembl clinical data and the AACR data announced this quarter, our confidence continues to grow. And that brings us to where we are today, in our ongoing Cardiff-Jericho IV trial for the treatment of first-line RAS-mutated MCRC. Overall, we believe that the initial data readout of Cardiff-004 has the potential to be an important value inflection point for Cardiff Oncology and for the nearly 50,000 patients diagnosed with Rasputin-positive MCRC each year.

Speaker Change: With that I will now open the call up for questions. Operator. Thank you so much and as a reminder, crestar one one to get in the queue and wait for your name to be announced.

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

Operator: One moment for our first question. It comes from Mark Frahm with TD Cowan. Please proceed.

Operator: One moment for our first question comes from Marc Frahm with TD Cowen. Please proceed.

Mark Erlander: Hi, Thanks for taking my questions just to start off on the okay. The tweak to guidance.

Mark Erlander: Our guidance on the on when the interim data might be come available can you just maybe clarify how much of the small pushout, what's really.

Speaker Change: You are kind of the enrollment pace one sites are open versus maybe just some delays getting the sites up and up and running as quickly as you had hoped.

Speaker Change: Well, yes, let me thanks, Marc for the question and let me just step back for a minute and just talk about the card search are poor trial.

Mark Erlander: And let me just step back for a minute and just talk about the CARB-004 trial. Over the last month or so, Dr. Fairooz Kabbinavar, our chief medical officer, and I have been going across the country and visiting with the principal investors that are participating in our trial. And Fairooz has actually been taking them through the previous data in the Phase 1B2 and the Ensembl data. And what I would say to you, universally, is that there is a high amount of enthusiasm about all of the principal death scares we have encountered.

Mark Erlander: Over the last month or so Dr. Bruce <unk>, our Chief Medical Officer.

Mark Erlander: <unk> have been going across the country and visiting with the principal investigators.

Mark Erlander: That are participating in our trial and peruse has actually been taking them through the previous data of the phase will be to and the ensemble data.

Mark Erlander: What I would say to you universally is that there is a high amount of enthusiasm.

Mark Erlander: All of the principal investigators we have met and the reason for that is not only because of the actual data that we're seeing building up to the trial that they are participating in now but also that.

Mark Erlander: And the reason for that is not only because of the actual data that they're seeing building up to the trial that they're participating in now, but also because the Onvanture tip does provide a novel new option for first lines in a first-line study, where, as you know, there have been no new therapies for 20 years. Also, one of the key things that makes them enthusiastic is the actual design of the trial because we're adding on to that, we're building it on to the current standard of care and not replacing it. And finally, also, there are no competing trials for a post-line blastoma.

Mark Erlander: <unk> chip does provide a novel new option.

Mark Erlander: For first lines in the first line setting, whereas you know there have been no new therapies for 20 years.

Mark Erlander: Also one of the key things that makes them enthusiastic is the actual design of the trial because we are adding on beverage. We're building it on to current standard of care and not replacing staff care and finally also there are no competing trials for a close line Ras mutated in CRC. So.

Mark Erlander: As I was saying earlier in the call, when we made the decision in the summer of 2023 to basically start Cardiff-004, that's when we then announced in August of 2023, prior to the trial starting, the forecast to share data in the Q2-Q3 timeframe of 2024. Now that we've got several months of enrollment and the pace of enrollment, we are able to now make a more accurate projection of the data share, and that is more... And so I think one thing, the last thing I'd say, Mark, is that, you know, why are we so confident of this timing?

Mark Erlander: As I was saying earlier in the call.

Mark Erlander: He started.

Mark Erlander: When we made the decision in the summer of <unk>.

Mark Erlander: Two of summer of 'twenty three to basically start card observes over four that's when we.

Mark Erlander: And then announced in August of 'twenty, two prior to the trial started.

Mark Erlander: The forecast to share data in the Q2 Q3 timeframe of 2024.

Mark Erlander: Now now that we've got several months of the enrollment and the pace of enrollment.

Mark Erlander: We are able to now make a more accurate projection of the data share.

Mark Erlander: That is more on the Q3 Q4.

Mark Erlander: And so I think one thing last thing I would say mark is that.

Mark Erlander: Why are we so confident of this timing.

Mark Erlander: That's really because we are leveraging Pfizer's resources, Pfizer Ignite's resources, their techniques, and their capabilities in multiple areas around the execution of this trial, and we are very confident of their effectiveness. Okay, great. That's helpful. And then maybe, just as we get to that data, can you kind of review some of the scenario planning that you and the team are kind of going through in terms of the data? I know it's not a formal statistical analysis there, but is there a scenario where it could get shut down, either more kind of from a futility perspective or also on the other end of the spectrum, making you want to kind of accelerate plans to open up OO5 even faster and not have to wait for all 90 days? Yeah, I mean, I think so.

Mark Erlander: Really because we are leveraging pfizer's resources, Pfizer ignites resources their techniques and their capabilities in multiple areas.

Mark Erlander: The.

Mark Erlander: Execution of this trial and we are very confident of their ability to execute.

Speaker Change: Alright, great Thats helpful and then.

Mark Erlander: Maybe just as we get to that data.

Mark Erlander: Some of the scenario planning that you have.

Mark Erlander: And the team are going through in terms of the data.

Mark Erlander: I know, it's not a formal statistical analysis, there, but is there a scenario where.

Mark Erlander: It could get shut down either more kind of from a utility perspective or also on the other end of the spectrum.

Mark Erlander: Nick you want to kind of accelerate plans to open up.

Mark Erlander: Yeah, I mean, right now, of course, what we are saying is that we will be looking to share data, initial data, in the Q3, Q4 timeframe, and we should have approximately half the patients of the trial, approximately that, with at least one post-baseline scan. I mean, one thing I would say about that time, and it's a great question, Mark, is that the 004, from the FDA's point of view, is really a dose confirmation trial with Project Optimist, and so the faster we can get to the FDA with a dose, of course, the better off we are and the better off we are as far as our timelines go into our registration.

Mark Erlander: Yes, I mean I think.

Mark Erlander: Right now of course, what we are.

Mark Erlander: What we're saying is that we will be looking to share data initial data in the Q3 Q4 timeframe, we should have approximately.

Mark Erlander: Half the half the patients of the trial.

Mark Erlander: Approximately that.

Mark Erlander: With at least one post baseline scan I mean.

Mark Erlander: Yes, Joe Joe for from the Fda's point of view is really a dose confirmation trial with project Optimists and so the faster we can get through the FDA.

Mark Erlander: With a dose of course, the better off we are in better off we are as far as our timelines is going into a registrational trial.

Speaker Change: Okay. Thanks.

Operator: Thank you. One moment for our next question, please. And it comes from the line between Joe Catanzaro and Piper Sandler. Please proceed.

Speaker Change: Thank you one moment for our next question. Please.

Mark Erlander: And it comes from the line of Joe Catanzaro with Piper Sandler. Please proceed.

Joseph Michael Catanzaro: Hey everybody. Thanks for taking my questions here. It may be the first one with the slight push in... The initial readout from OO4, I'm wondering if there's a possibility of maybe seeing another cut of the ensemble cohort before then, just getting longer follow-up and a better sense of the durability of responses and how that's shaking out between, you know, the arms of the trial, the Bev-Naive and Bev-Experienced arms, so any thoughts there would be helpful, and I might have a follow-up

Joseph Michael Catanzaro: Hey, everybody. Thanks for taking my questions here.

Speaker Change: First one with the slight push in.

Joseph Michael Catanzaro: The initial readout from O four I'm wondering if there is a possibility of maybe seeing another cut.

Joseph Michael Catanzaro: Sample cohort.

Joseph Michael Catanzaro: For them just before then just getting longer follow up with a better sense of the durability of responses and how thats shaking out between.

Joseph Michael Catanzaro: The arms of the trial.

Joseph Michael Catanzaro: So any thoughts there would be helpful.

Mark Erlander: Yeah, thanks, Joe, for the question. I mean, as we sit here today, you know, we did announce the data on February 29th for the Ensembl trial, and we felt that that was a very robust data set that propelled us with even greater confidence into our 004. But, as we sit here now, we don't have plans to have a continued follow-up of the Ensembl trial.

Speaker Change: Yes, Thanks, Jeff for the question I mean, as we sit here today, we do.

Joseph Michael Catanzaro: Did announce the the data on February 29th sample.

Mark Erlander: Trial, and we felt that that was a very robust dataset that propelled us with even greater confidence into our <unk> zero four.

Joseph Michael Catanzaro: Okay. Thanks.

Mark Erlander: As we sit here now we don't have plans to have a continued follow up of the ensemble data.

Speaker Change: Okay. Thanks, and then maybe my follow up is on the preclinical work at ACR in the Ras Wild type CRC scenario.

Mark Erlander: And then maybe my follow-up will be on the preclinical work at AACR on the RAS wild-type CRC scenario. I recall years ago the synthetic lethality idea of PLK1 inhibition in the context of a mutant RAS. It seems like you're sort of thinking outside of that, and you mentioned potentially exploring it. Can you elaborate on whether there's an opportunity to explore that clinically and think about that population of patients within the context of a potential future? Pivotal Frontline Trial

Mark Erlander: Alright.

Mark Erlander: I recall years back the synthetic lethality idea of <unk> inhibition in the context of mutant rats, it seems like youre sort of.

Mark Erlander: Thinking out side of that and you mentioned potentially exploring it maybe you could just elaborate whether there is opportunity.

Mark Erlander: Floor that clinically and think about that population.

Mark Erlander: Patients within the context of the.

Mark Erlander: Potential future.

Mark Erlander: Pivotal frontline trial.

Joseph Michael Catanzaro: Yeah, great question, Joe. I'd say, you know, first of all, when you look at rats, wild-type and rats, mutant tumors, and colony, those are very different beasts, very different animals in the sense of biology. And so, you know, as you know, we did, we have shown synthetic lethality in the RAS mutant background. But in RAS wild type, I think it's a different biology.

Speaker Change: Yes, Great question, Joe I'd say first of all.

Mark Erlander: The.

Joseph Michael Catanzaro: When you look at.

Joseph Michael Catanzaro: Ras Wild type in Ras mutant tumors and colorectal those are very different these are very different animals in the sense of the biology and so.

Joseph Michael Catanzaro: As you know we did we have shown synthetic fatality in the Ras mutant backer.

Joseph Michael Catanzaro: Background in Ras Wild type I think it's a different biology, and I think that we are seeing a very interesting.

Mark Erlander: And I think that we are seeing a very interesting finding where we are combining cetuximab. And so I think as we sit here today, we are evaluating what kind of trial design that would be in the wild type setting. But we haven't, you know, we have not made any moves yet in that area. Our focus as we sit here today continues to be 004 and getting the data toward registration.

Joseph Michael Catanzaro: Finding where we're combining with cetuximab.

Mark Erlander: We are evaluating what kind of trial design that would be in the wild type setting, but we haven't we have not made any move yet in that area. Our focus as we sit here today continues to be Joe therefore, and getting getting the data toward the Registrational trial.

Joseph Michael Catanzaro: Okay, I got it. That's all helpful. Thanks for taking my question.

Speaker Change: Okay got it that's all helpful. Thanks for taking my questions.

Operator: Thanks, Joe. Thank you. One moment for our next question, and it comes from Andy Xie with William Blair. Please proceed.

Speaker Change: Absolutely. Thanks, Joe. Thank you one moment for our next question.

Joseph Michael Catanzaro: And it comes from Andy here with William Blair. Please proceed.

Andy Xie: Great, thanks for taking our questions. A couple of quick ones from us, if you don't mind. So, in terms of clinical sites, I believe, Mark, you said 24 sites right now. I believe it was 20 before and is your end goal being 30 total by the end of enrollment completion.

Andy Xie: Great. Thanks for taking our questions a couple of quick ones from us.

Andy Xie: Mark You said 24 sites right now I believe it was.

Andy Xie: <unk> before and if your end goal being B 30 total by the end of the enrollment completion.

Mark Erlander: Yeah, thanks Annie for that question. So, you're right, as of today, we have 24, and our goal, actually, in working with Pfizer-Ignite is to activate 35 sites. And we are also looking at some additional sites. But one of the things to keep in mind with this is that this is a very dynamic process in the sense that we continue to evaluate sites, and if the site is not performing, then that site could be replaced by another site. So, you know, the number is not always static. It's really more dynamic as we go through this trial and continue to act.

Mark Erlander: Yes, thanks for that question so.

Mark Erlander: As of today, we have 24 and our our goal actually in working with Pfizer ignite is to activate 35 sites.

Mark Erlander: We are also looking at some additional sites, but one of the things to keep in mind that with just.

Mark Erlander: Just a very dynamic process.

Mark Erlander: In a sense that we continue to evaluate sites in the site.

Mark Erlander: He is not performing then that sites will be replaced with another site. So.

Mark Erlander: The number is not always static it's really more dynamic as we can.

Andy Xie: Okay, that's helpful. Thank you.

Mark Erlander: Okay.

Speaker Change: That's helpful. Thank you.

Speaker Change: And just kind of follow up on March question before.

Mark Erlander: And just kind of follow up on Mark's question before, you mentioned about Project Optimist, two doses in the 004 study. Is it conceivable to bring two doses in the pivotal study? Is that a potential scenario? And I guess, you know, from an FDA perspective, beyond kind of confirmation of safety and efficacy, what else are they looking at before giving you the okay to start a pivotal study?

Andy Xie: You mentioned about project Optimists, two doses in the <unk> study.

Mark Erlander: Is it is it conceivable to bring two doses in the pivotal study is that a potential scenario and I guess from a.

Mark Erlander: FTA perspective beyond thank him for confirmation as safety efficacy what else are they looking at before giving you the okay to start a pivotal study.

Andy Xie: Right. Thanks for the question.

Speaker Change: Right. Thanks for the question.

Mark Erlander: And just to answer those questions kind of literally, first off, we don't expect to go into the registrational trial. We plan to have a single... And you're right, what the FDA looks for is really whether there is a difference between the efficacy between the two doses, and is there a difference in safety. Both those things we will be continuing to evaluate, not only using our existing data but, obviously, also the 004 data.

Mark Erlander: We plan to have a single awards.

Mark Erlander: And Youre right with the FDA looks for.

Mark Erlander: Is really is there a difference between the efficacy between the two doses and is there a difference in the safety.

Mark Erlander: Both of those things, we will be continuing to evaluate not only using our our existing data, but also the Georgia, obviously, the Georgia for data and like I said to Mark.

Mark Erlander: Our goal.

Mark Erlander: Confirmation of dose with the FDA. So of course, we are very focused on getting that as soon as possible.

Andy Xie: Great, then maybe my last question has to do with catalyst events. So, Jamie, you talked about Q3 2025 being the cash runway, you know, perhaps you could give us maybe a big picture of you. Obviously, the 004 study is happening in the second half of this year. Any others? potential data readouts that we can expect in the first three quarters of 2025 that could allow us to better appreciate the clinical activity of Vancertib

Speaker Change: Great and then maybe my last question has to do with.

Mark Erlander: Yes.

Andy Xie: Catalyst events.

Andy Xie: So Jamie you talked about Q3 2025 being the cash runway.

Andy Xie: Perhaps can you give us maybe a big picture view, obviously <unk> steady happening in the second half of this year.

Andy Xie: Any other.

Jamie: Essential data Readouts that you can expect in the first three quarters of 2025 that good.

Andy Xie: Allow us to better appreciate the clinical activity of the answers yet.

Mark Erlander: Well, it's a great question. We're not prepared at this point to set dates for some of the investigator-initiated trials that we do actually have ongoing right now. Those could potentially be, but we're just not prepared to put it out in the public, okay, this is the time that we would announce data on those trials. But clearly, we are looking at those as well as we continue to keep a laser focused on the zero trials.

Jamie: Yes, Great question, we are not prepared at this point to a set date.

Mark Erlander: Some of the investigator initiated trials that we do actually have ongoing right now.

Mark Erlander: Those could be potentially but we're just not prepared.

Mark Erlander: To set put out in the public. Okay. This is the time that we announced data on those trials, but clearly we are looking at those as well as we'll continue to keep our laser focused on the zero to report.

Andy Xie: Got it. I understand. All right. Thanks so much for answering all of our questions.

Speaker Change: Got it I understand alright, thanks, so much for answering all of our questions.

Operator: Thank you. I will conclude the Q&A session as I see no further questions and hand them back to Mark Erlander. Thank you. Thank you, operator. And this concludes our conference call. Thank you once again, everyone, for joining us this afternoon. Have a good day. Thank you. You may all disconnect.

Speaker Change: Thank you Andy.

Speaker Change: Thank you and I will conclude the Q&A session I see no further questions and have them back to Mark Erlander. Thank you.

Mark Erlander: Thank you operator. This concludes our conference call. Thank you once again, everyone for joining US this afternoon have a good day.

Operator: Thank you you may all disconnect.

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