Cardiff Oncology Q3 2023 Earnings Call Transcript

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November 2, 2023

There are 7 speakers on the call.

Operator

Welcome to the Cardiff Oncology Third Quarter 2023 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen only mode. Following management's prepared remarks, we will hold a Q and A session. To ensure that we have ample time to address everyone's questions during the Q and A session, we would ask for a limit on your touch tone phone. As a reminder, this call is being recorded today, November 2, 2023.

Operator

I would now like to turn the conference call over to Kiki Patel of Gilmartin Group. Please go ahead.

Speaker 1

Thank you, operator. Joining us on the call today from Karyoph Oncology are Chief Executive Officer, Mark Erlander and Chief Financial Officer, Jamie Lundin. During this conference call, management will make forward looking statements, including without limitation, statements related to guidance, results and the timing of data readout for ONVANTAGES 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.

Speaker 1

Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors and our annual report on Form 10 ks for the year ended December 31, 2022, filed with the SEC on March 2, 2023. Cardiac 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. Slides for today's investor call can be found on the Homepage and Events and Revitations tab on the Cardio Oncology website at www.cargooncology.com. With that, I'll turn the call over to Chief Executive Officer, Mark Erlanger.

Speaker 2

Mark? Thank you, Kiki, and good afternoon, everyone, and thank you for joining our Q3 2023 financial results and the corporate update conference As you can see on Slide 3, this past quarter was transformational for Cardiff Oncology. In August, we announced strong new data from our lead program in KRAS mutated metastatic colorectal cancer. The conclusion is from a highly supported meeting with the FDA and expansion of our relationship with Pfizer. Then in September, we released data with 2 earlier stage programs in pancreatic cancer and small cell lung cancer, which included a clear efficacy signal for monvantrotum monotherapy in both indications.

Speaker 2

Today, we would like to put all of this in context and explain our strategy to you all and demonstrate how we can create shareholder value going forward. As we all know, these are challenging times for publicly listed biotech companies. But card of oncology has a collection of strengths from which to build value. As we list on Slide 4, these include 1st and foremost, our drug Onvansertib has shown clear signals of efficacy and tolerability in combination with chemotherapies and as a single agent in our clinical trials across multiple indications. 2nd, ombansertib is the only PLK1 specific inhibitor in clinical development, meaning on the answer to is the 1st in class molecule for this well understood target for cancer therapies.

Speaker 2

3rd, ombansertib can combine synergistically with and is well tolerated in many first line and second line standard of care regimens. This enables us to address some of the most common and deadliest Cancer indications in early lines of therapy where there are the large patient populations that could be positively impacted. The fact that we are targeting first line patients in both metastatic colorectal cancer and pancreatic cancer are good examples of this. 4th, we have clear third party support for our plans And this includes the FDA and Pfizer. And finally, we have the financial resources To pursue our strategy in a thoughtful and methodical manner with the crash runway into 2025.

Speaker 2

As we go to Slide 5, we show 3 objectives for Cardiff Oncology that we believe will create value for all of our stakeholders. And let me be very clear, our primary focus is our lead program in RAS mutated metastatic colorectal cancer. We are currently working closely with Pfizer IGNITE To execute the clinical development plan that the FDA has agreed to and to generate data from our first line CARTF004 clinical trial in mid-twenty 24. Our second objective is to continue to generate additional clinical data from our trials in pancreatic cancer, Small cell lung cancer and triple negative breast cancer, which we plan to do in a capital efficient manner through investigator initiated trials. Finally, our third objective is rooted in our conviction The PLK1 inhibition has an even larger role to play in cancer therapy.

Speaker 2

As we have for other clinical programs, We will make data driven decisions with strong commercial logic to explore new promising combinations and cancer indications. Our current efforts focus on cost effective preclinical studies. By executing towards these objectives, we can create significant value for all of our stakeholders. And we believe the data and the plans we announced in the Q3 from a shareholder perspective reduce the risk of our clinical development plan, while increasing the reward potential given the larger commercial opportunity that we are now pursuing. Let's move to Slide 6.

Speaker 2

Here, we're summarizing the key accomplishments during the Q3 of our lead program in metastatic colorectal cancer. As you know, in August, we shared a series of findings from our second line Phase 1btwo clinical trial and KRAS mutated metastatic colorectal cancer. About a quarter of the patients who came into our second line trial We're not treated with bevacizumab or bev in their prior first line treatment. For this bev naive patient, we saw Strong responses to the combination of our drug on Vansertwo with the second line standard of care, which includes bev. Specifically, 73% of bev naive patients had a confirmed objective response to treatment versus historical controls that had demonstrated rate of around 25%.

Speaker 2

And these patients also remained on our trial for a median We were highly encouraged by these data, which suggested that there was a new mechanism of action of onvansertib at play that was previously unknown. Observing a 3 fold increase in response rate, a doubling in the median PFS In bev naive patients was a signal too strong for us to ignore. So as a next step, we investigated the underlying science through a 12 month multi phase preclinical program. The preclinical work led us to conclude That both Onvanceerton and Bev have independent mechanisms of action that work together to restrict a tumor's blood supply, thereby significantly decreasing tumor growth. We next asked, Why is this clinical finding only observed in bev naive patients and not in patients who were treated with bev in the first line setting?

Speaker 2

To answer this question, we engaged an independent research firm called TEMUS to conduct a clinical study that analyzed tumor data from 135 KRAS mutated metastatic colorectal patients cancer patients. This analysis show that once patients were exposed to bep in the first line setting, their tumor genomics And this change is consistent with generating tumor resistance to ombasertib and bev in the second line setting. We believe this explains why we observed strong positive clinical results in our Phase 1btwo trial in the bev naive, but not the bev exposed patient populations. Now armed out with these findings, We shared our clinical and preclinical data with the FDA in a Type C meeting in June of this year. The FDA suggested we move our clinical development program of ombansertib up to the first line, where all patients are bev naive and where we have the opportunity to positively impact the largest We responded to the FDA suggestion by proposing a development plan with 2 clinical trials.

Speaker 2

The first trial, CARD F-four, We'll provide randomized data for both efficacy and dose confirmation. Then We can conduct a subsequent registrational trial, CARTE-five, where the FDA provided clear guidance for a path to both accelerated approval and full approval from one trial. Finally, we shared the full data package and FDA conclusions with members of our Scientific Advisory Board, which includes a representative from Pfizer. As you know, Pfizer initially invested in cardiop oncology 2 years ago, having seen full development of the clinical, Preclinical and FDA response I just described, they proposed to us that Pfizer Ignite Conduct the CARDIT004 first line clinical trial. Now every partnership that Pfizer Ignite considers Undergoes close internal scrutiny by the Chief Scientific Officer along with other key scientific team members at Pfizer.

Speaker 2

They gauge the potential of each project, ensuring collaborations are mutually beneficial and aligned with Pfizer's broader goals. As we announced in August, our new relationship with Pfizer Ignite allows us to leverage their clinical development horsepower To execute our CARTF004 clinical trial, while importantly, This month, November, the first group of our planned 30 clinical trial sites across the United States RECARTIV004 will be open to enrollment. We anticipate enrolling patients shortly thereafter and plan to report preliminary results in the middle of next year. With this, I'd like to turn now to our earlier stage programs, which are highlighted on Slide 7. In September, we announced signals of efficacy in metastatic pancreatic cancer from 2 clinical trials, which support our planned path forward in the first line setting.

Speaker 2

The first trial, CAR TAV-one, As you know, it evaluates on VASTRUDE's efficacy and tolerability in the second line setting of pancreatic ductal adiocarcinoma or From CAR TAP-one, we reported 4 of our 21 patients where 19% achieved and Objective Partially Response or PR. As of the data cut off of September 13, 2023, 3 of the 4 patients with PRs were still awaiting their confirmatory scans. As of today, November 2, One of these 3 patients, patient 42 has now shown the further deepening of response at their 4 month scan, therefore representing a second confirmed PR on this trial. We are still awaiting confirmatory scans for the remaining 2 patients With an unconfirmed PR who remain on treatment, one for about 8 months and another for over 9 months. This is much longer than historical media progression free survival of 3.1 months for second line.

Speaker 2

Overall, for all evaluable patients, we reported a median progression free survival of 5 months, which is encouraging since this approaches The benchmark of the first line median PFS, which is 5.5 months, indicating yet another strong signal of efficacy in this indication. The second trial in pancreatic cancer is an investigator initiated biomarker discovery trial In metastatic PDAC, where ombansertib's effects on tumors is being evaluated as a single agent. As you recall from our last call, the data we were presented in September showed the effects on tumor biomarkers with onvansertib monotherapy after only 10 days of treatment. Because of these encouraging results that we observed today With ombasertib from both trials, we plan to move to the first line setting through a new investigator initiated trial to be conducted at the Oregon Health and Science University, Knight Cancer Institute. This first line design Enables us to potentially have the greatest opportunity to impact these challenging diseases at an earliest possible stage, When the chances of patients responding to treatment are the highest.

Speaker 2

Finally and important, this approach allows us to generate data In September, we also presented the first look data from an investigator initiated trial in refractory extensive stage small cell lung cancer. The trial treats patients with ombansertib monotherapy and is being conducted at the University of Pittsburgh Medical Center. Of the first seven patients that have been treated as of September 26, 2023, 1 had a confirmed partial response, 3 stable disease and 3 progressive disease. Seeing a confirmed partial response, which the investigator assessed as a 50% shrinkage of the tumor from treatment with ombansertib monotherapy provides a clear signal of ombansertib's efficacy in this challenging disease. Our current plans are to continue enrollment in this trial, but as we reported in September, our expectation is that a future clinical path forward in small cell lung cancer is most likely to include a combination regimen of ombansertib with second line standard of care paclitaxel.

Speaker 2

Finally, the investigator initiated trial in triple negative breast cancer continues to enroll and we'll provide data from that trial when it becomes available. Okay. So, so far I've discussed our ongoing programs and plans. But our 3rd objective to create value For our stakeholders is to investigate new therapeutic indications for ONVANSATIP. For example, The recent discovery of the power of the ONVANCITIVE BAB combination indicates that we should aggressively explore through preclinical models Indications where bev is FDA approved.

Speaker 2

This includes RAS wild type colorectal cancer, lung, liver, We also know that ombansertib is antimyotic, Given that PLK1 plays a critical role in cellular mitosis, which is the process through which a cancer cell divides from 1 cell to 2, There is extensive literature suggesting the combination of 2 antimytotic agents could be synergistic And we have been exploring this combination in preclinical models with dramatic results. To give one example, I will share some new Breast cancer is the most common form of cancer diagnosed today in the United States. And hormone receptor or HR positive breast cancer represents about 80% of breast cancer cases. In metastatic HR positive breast cancer, tumor cells can develop resistance to first line treatment, In part by over expressing PLK1, paclitaxel, an anti mitotic agent is a common 2nd agent therapy, making it an ideal drug to explore in combination with ombansertib in this setting. The data on Slide 6 shows how treatment with ombansertib, paclitaxel and the 2 agents combined impact Patient derived xenograft models resistant to first line treatment with pavalecilib in HR positive breast cancer.

Speaker 2

We observed highly significant tumor regression with the combination with over 50% As we look at this here at Cardiff Oncology, we believe this data supports our broader vision for Ondanser-two. And we remain committed to a cost effective approach using preclinical models to validate additional indications and Combinations. Now I will turn it over to our CFO, Jamie Levine, to go over the financial results for the Q3 2023. Jamie?

Speaker 3

Thank you, Mark. Earlier today, we issued a press release Summarizing our financial results for the Q3. And on Slide 9, we share the financial highlights. You can also find additional information and our Form 10 Q for the Q3 filed with the SEC earlier today. Turning to our balance sheet, Cash and short term investments as of September 30, 2023 totaled $81,400,000 And net cash used in operating activities for the Q3 of 2023 was approximately $8,000,000 Based on our current expectations and projections, we believe our cash resources are sufficient to fund operations into 2025.

Speaker 3

With that, I'll turn the call back over to Mark.

Speaker 2

Well, thank you, Jamie. As we close today, You can see from the data we have generated today, we here at Cardiff Oncology truly believe We have a pipeline in a product and we have found highly capital efficient ways to explore these efficacy signals. And with data expected mid next year from our first line RAS mutated metastatic colorectal cancer trial, We have an important near term catalyst from our lead program. So while we recognize the challenges facing the broader biotech industry, we believe that The strength of our data, the clarity and support we received from our recent FDA meeting, our expansion has the potential to create enormous value for our stakeholders, including our shareholders and most importantly, With that, I will now open the call up for questions.

Operator

Our first question comes from the line of Mark Frahm from TD Cowen.

Speaker 4

Thanks for taking my questions. Maybe first on the clinical side, just at the last update, there were 3 unconfirmed PDAC responses. Just I'm not sure if maybe some of those patients have had a chance to have a confirmatory scan in the last month or 2. And if so, And then on the finance side, maybe Jamie, can you just talk through kind of the expense trajectory here as the first line trial in colorectal starts And some of these other ISVs, I know it's not a big lift on your part, but just as some of those start up as well.

Speaker 2

Okay. Well, thanks Mark for your question. So regarding the CART-one PDAC trial, As you stated, we had 4 PRs that we announced with one being confirmed on our September call. What we're announcing today is continuing following these patients and now we have a second patient who had a deepened response We have 2 remaining patients who have not had their next scan, One has been on treatment for 8 months and other has been on treatment for over 9 months. And so, we plan at some date in the future, we will Update that trial, but that's where we stand today.

Speaker 2

And I'll now turn it to Jamie to unless, Mark, there's any more clarity you need on that.

Speaker 5

No, no. That's very helpful. Thanks.

Speaker 3

So Mark, from an expense trajectory, what we'd say is we have a few trials that are actually Going to be winding down as we've talked about our plans in MCRC, the Phase IbII trial It's going to be winding down. We're also shifting away from our 2nd line PDAC trial into the first line IIT that Mark talked about earlier on the call. So that's happening at the same time as we are ramping up our CARTF004 trial. So when we look at our overall Our net expenses going forward, we do expect that they're going to increase, but not significantly. And I think when you put that together with the $81,000,000 we have at the end of the 3rd quarter, You can see once again we burned $8,000,000 this quarter.

Speaker 3

That's in line with where we've been in the past. And so that is the basis on which we make the statement that our current cash extends into 2025.

Speaker 5

Great. Thanks. Very helpful.

Operator

Sure. One moment for our next question. Our next question comes from the line of Joe Catanzaro from Piper Sandler.

Speaker 5

Everybody, appreciate you taking my questions. Maybe just a couple from me on the 4 study. We'd love to just sort of get your sense around your level of confidence around being able to generate these interim data by mid-twenty 24 given dosing Hasn't started yet. Wondering if you have any internal projections on how quickly you can enroll these planned 90 patients? And then have you said whether this data readout is triggered by a specific number of patients reaching a specific amount of follow-up?

Speaker 5

Any details there would be helpful.

Speaker 2

Thanks. Hi, Joe. Yes, we remain very bullish in being able to put out The first interim data or preliminary data from the trial. As you know, We are working very closely with Pfizer Ignite. And Pfizer Ignite, we're very pleased because Pfizer Ignite is actually Conducting and implementing and executing the CAR T004 randomized trial.

Speaker 2

And so we are going off of where those projections are and we do believe that we will be able to have Data to talk about. Now keep in mind, we'll be watching the trial. It's a the trial itself is an open label trial. So we'll be able to watch the progress of that as we start to enroll patients. But we do remain confident to be able to give information Sometime mid next year.

Speaker 5

Okay. That's helpful. And then in terms of the Actual sort of data readout, my follow-up there was, whether that's triggered by something formally in the protocol as it relates to sort of number of patients And the amount of follow-up?

Speaker 2

No, it's not. It's really we're watching as It's open label, so it's going to depend on the magnitude of the effect that we do see. So but there is no trigger in the protocol.

Speaker 5

Okay, got it. That's very helpful. Thanks for taking my question.

Speaker 2

Sure. Thank you, Joe.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Andy Chai from William Blair.

Speaker 6

Great. Thanks for taking my questions and congratulations on all the progress. Two questions, if you don't Fine. One has to do with, Mark, I believe, when you're conducting the Phase The 2 study before, there was a strategy employed to kind of minimize The adverse event from kind of switching between bolus 5FU and F5FU, I'm just curious if that strategy is also being employed in 4 and 5. And then look to hear, obviously, with this expanded pipeline development plan, look to hear your thoughts on the IP strategy in terms of market exclusivity?

Speaker 6

Thank you.

Speaker 2

Okay. The first question, Andy, regarding the bolus, we're continuing to have that be an optional for The treatment arms and but in the control arm, the FDA has asked that they consider to be standard of care To have the 5.50 bolus. So but we will continue to do what we've done in the Phase 1b2 trial. Your second question, maybe Andy, maybe you could repeat that again, just so I make sure I ask that correctly.

Operator

Thank you. At this time, I would now like to turn the conference back over to Mark Erlander for closing remarks.

Speaker 2

Well, thank you all for your time. And this concludes our conference call. And thank you once again for joining us this afternoon.

Operator

This concludes today's conference call. Thank you for participating. You may now

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Cardiff Oncology Q3 2023
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