Q3 2023 Cardiff Oncology Inc Earnings Call
Yeah.
Welcome to the card is 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&A session to ensure that we have ample time to address everyones questions. During the Q&A session. We would ask for a limit of one question and one follow up question per person to ask a question at that time.
Please press star followed by one one on your Touchtone phone.
As a reminder, this call is being recorded today November 2nd 2023, I would now like to turn the conference call over to Kiki Patel of Gilmartin Group. Please go ahead.
Thank you operator, joining us on the call today from cards oncology, our Chief Executive Officer, Mark or a lender and Chief Financial Officer, Jamie with me. During this conference call management will make forward looking statements, including without limitation statements related to the guidance results and the timing of theater, so advantage of clinical trials.
These forward looking statements are based on 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.
We described in the section titled Risk factors in our annual report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 2nd 2023.
Cortisol calls the undertakes no duty or obligation to update any forward looking statements as a result of new information future events or changes in expectations.
Slides for today's Investor call can be found in the movies and events and presentations tab on the part of oncology website at Www Dot.
Dot com with that I'll turn the call over to Chief Executive Officer, Mark <unk>, Mark. Thank you <unk> and good afternoon, everyone and thank you for joining our third quarter 2023 financial results and corporate update conference call.
As you can see on slide three this past quarter was transformational for <unk> phone calls in August we announced strong new data from our lead program and K Ras mutated metastatic colorectal cancer.
The conclusions from a highly supportive meeting with the FDA.
And the expansion of our relationship with Pfizer then in September we released data with two earlier stage programs in pancreatic cancer and small cell lung cancer, which included a clear efficacy signal from one vantage of monotherapy in both indications.
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. The Carnival oncology has a collection of strengths from which to build value.
As we list on slide four.
These include first and foremost our drug on vantage it is.
As shown clear signals of efficacy and Tolerability in combination with chemotherapy and as a single agent in our clinical trials across multiple indications.
On advanced Chip is the only <unk> one specific inhibitor in clinical development.
Meaning on the answer to it is the first in class molecule for this well understood target for cancer therapy.
Third on Vance or Tim can combine synergistically with and is well tolerated in many first line and second line standard of care regimen.
This enables us to address some of the most common and deadliest cancer indications in earlier 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.
We have clear third party support for our plan and this includes the FDA and partner.
And finally, we have the financial resources to pursue our strategy in a thoughtful and methodical manner.
With the cash runway into 2025.
As we go to slide five we show three objectives for our card up 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 and 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 Cartersville, Georgia for clinical trial in mid 2024.
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 that <unk> inhibition has an even larger role to play in cancer therapy.
As we have for other clinical programs.
We'll 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 third quarter 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 six here, we're summarizing the key accomplishments during the third quarter of our lead program in metastatic colorectal cancer.
As you as you know in August we shared a series of findings from our second line based on the two clinical trial and K Ras mutated metastatic colorectal cancer.
About a quarter of the patients who came into our second line trial.
Were not treated with debit Superman or Bev and their prior first line treatments.
Or this bev nave patients we saw strong responses to the combination of our drug advance or two with the second line standard of care, which includes Beth <unk>.
Typically 73% of Bev naive patients had a confirmed objective response to treatment.
Historical controls that have demonstrated rate of around 25%.
And these patients also remained on our trial for a median time of 15 months before their disease progressed versus historical controls of seven to eight months.
We were highly encouraged by these data, which suggested that there was a new mechanism of action on the answer to that was previously unknown.
Observing a threefold increase in response rate of doubling and the median PFS and Bev naive patients was a signal too strong for us.
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 bolt on to answer Tim and Beth.
Have independent mechanisms of action that work together to restrict or tumors blood supply, thereby significantly decreasing tumor growth.
We know we next asked.
Why is this clinical finding only observed in bev naive patients and not in patients who were treated with <unk> in the bed and the first line seven.
To answer this question.
<unk> engaged an independent research firm called templates to conduct.
A clinical study that analyzed tumor biopsy data from 135, K Ras mutated metastatic colorectal colorectal patients cancer patients.
This analysis showed that once patients were.
Both to bear in the first line setting.
The tumor genomics or changed.
And this change is consistent with generating tumor resistance to <unk> and debt in the second line setting.
We believe this explains why we observed strong positive clinical results in our phase <unk> trial in the Bev naive, but not the bev exposed patient populations.
Now armed 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 <unk> up to the first one.
Where all patients are bev naive.
Where we have the opportunity to positively impact the largest patient population of RAF mutated metastatic colorectal cancer.
We responded to the FDA suggestion by proposing a development plan with two clinical trials.
The first trial <unk> zero, therefore will provide randomized data for both efficacy and dose confirmation.
Then we can conduct a subsequent registrational trial.
Zero, 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 fiber.
As you know Pfizer initially invested in Cardiff oncology two 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 Cardiff Zero-zero for 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.
They gave us the potential of each project, ensuring collaborations are mutually beneficial and align with pfizer's broader goals.
As we announced in August our new relationship with Pfizer ignite allows us to leverage their critical development horsepower.
To execute our Carter zero-zero for clinical trial, while importantly.
Cardiff oncology maintains all economic ownership and control of unanswered.
This month November the first group of our planned 30 clinical trial sites across the United States, where part of Georgia 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 seven.
In September we announced signals of efficacy in metastatic pancreatic cancer from two clinical trials, which support our planned path forward in the first line setting.
The first trial part of <unk> one as.
As you know evaluate <unk> efficacy and Tolerability in the second line setting of pancreatic ductal adenocarcinoma or metastatic PD.
From <unk>, we reported four of our 21 patients were 19% achieved an objective partial response or PR.
As of the data cutoff of September 13, 2023, three of the four patients with Prs were still awaiting their confirmatory scans.
As of today November 2nd.
One of these three patients patients <unk> has now shown the further deepening of response at their former scan therefore, representing a confirmed PR on this trial.
We are still awaiting confirmatory scans for the remaining two patients with an unconfirmed PR who remain on treatment one for about eight months and another for over nine months.
This is much longer than historical median progression free survival.
Survival of $3 one months for second line.
Overall for all Evaluable patients, we reported a median progression free survival of five months, which is encouraging since this approaches the benchmark of the first slide median PFS, which is five five 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 P deck, we're on bouncer tubes effects on tumors is being evaluated as a single agent as Youll recall from our last call. The data we presented in September showed.
Effects on tumor biomarkers with on vantage a monotherapy after only 10 days of treatment.
Because of these encouraging results that we observed to date with <unk> from both trials, we plan to move to the first line setting through a new investigator initiated trial to.
To be conducted at the Oregon Health and Science University Knight Cancer Institute.
This first slide design enables us to potentially have the greatest opportunity to impact these challenging diseases as an earliest possible stage when the chances of patients responding to treatment or the audience.
Finally, an important this approach allows us to generate data in a capital efficient manner.
In September we also presented the first look at data from an investigator initiated trial in refractory extensive stage small cell lung cancer.
A trial treats patients with on Vansittart monotherapy and is being conducted at the University of Pittsburgh Medical Center.
Of the first seven patients have been treated as of September 26, 2023, one had a confirmed partial response three stable disease in three progressive disease.
Seen a confirmed partial response, which the investigator assessed as a 50% shrinkage of the tumor from treatment with on balance. It's a monotherapy provides a clear signal of <unk> efficacy in this challenging disease.
Our current plans are to continue enrollment of 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 on dancer with second line standard of care Paclitaxel.
Finally, the investigator initiated trial in triple negative breast cancer continues to enroll.
And we will provide data from that trial when it becomes available.
Okay. So so far I've discussed our ongoing programs and plans.
But our third objective to create value for our stakeholders is to investigate new therapeutic indications for our advanced chip.
For example.
The recent discovery of the power of the <unk> Bev combination indicates that we should aggressively explore through preclinical models indications were that is FDA approved.
This includes Ras wild type colorectal cancer lung liver kidney surgical and ovarian cancer.
We also note that on balance or TIB is antimitotic given that <unk> one plays a critical role in cellular mitosis.
Is the process through which a cancer cell divides from one cell to too.
There is extensive literature, suggesting the combination of two anti mitotic agents could be synergistic and.
And we have been exploring this combination in preclinical models with dramatic results.
To give one example, I will share some new preclinical data for hormone receptor positive or HR positive breast cancer.
These results are shown on slide eight.
Breast cancer is the most common form of cancer diagnosed today in the United States.
In 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 <unk> one.
Paclitaxel and anti mitotic agent is a common second agent therapy, making it an ideal drug to exploring combination with on advantage of in this setting.
The data on slide six shows how treatment with <unk> <unk>.
Paclitaxel in the <unk> combined impact patient derived xenograft models resistance to first line treatment with Cabo Cipla in HR positive breast cancer.
We observed highly significant tumor regression with the combination with over 50% of the tumors within each model, having a complete response to the combination treatment.
As we look at this here at Cardiff Oncology, we believe this data support our broader vision for on to answer too.
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 third quarter 2021, Jamie.
Thank you Mark.
Earlier today, we issued a press release summarizing our financial results for the third quarter and on slide nine we share the financial highlights.
Can also find additional information in our Form 10-Q for the third quarter filed with the SEC earlier today.
Turning to our balance sheet cash and short term investments as of September 32023 totaled $81 4 million.
And net cash used in operating activities for the third quarter of 2023 was approximately $8 million.
Based on our current expectations and projections, we believe our cash resources are sufficient to fund operations into 2025.
With that I'll turn the call back over to Mark.
Well. Thank you thank you Jamie.
Let me close today, you can see from the data we have generated to date.
Here to carp oncology truly believe we have a pipeline in a product.
And we have found a highly capital efficient ways to explore the efficacy signal.
And with data expected mid next year.
From our first line Ras mutated metastatic colorectal cancer trial, we have a an important near term catalysts.
From our lead program.
So while we recognize that the challenges facing the broader biotech industry.
We believe that the.
The strength of our data.
Clarity and support we received from our recent FDA meeting.
Our expansion of our relationship with Pfizer and our strong financial position clearly show that Kartik oncology has the potential to create enormous value for our stakeholders, including our shareholders and most importantly.
The patients we intend to serve.
With that I will now open the call up for questions operator.
As a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again.
Our first question comes from the line of Marc Frahm from TD Cowen.
Hi, Thanks for taking my questions, maybe first on the clinical side.
At the last update there were three unconfirmed PR responses just im not sure if maybe some of those patients had a chance to have a confirmatory scan in the last month.
A month or two and so were any of them able to confirm.
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 to ramp up.
And some of these other Isps.
Big lift on your part, but just that some of the startup as well.
Okay, well thanks, Mark for your question so regarding the Cardiff Joser, one pediatric trial.
As you stated we had four <unk> that we announced with one being confirmed on our September call.
What we're announcing today is is continuing and following these patients and now we have a second patient who had a deep in response and confirmed now has a confirmed PR.
We have two remaining patients who have not had their next scan one been on treatment for eight months another spin on treatment for over nine months and so we.
We planned at some date in the future, we will update that trial, but thats, where we stand today.
And I'll now turn it to Jamie to unless Mark was any more.
More clarity you need on that.
Alright, that's very helpful. Thanks.
So mark from an expense trajectory, what we'd say is we have a few trials that are actually going to be winding down.
We've talked about our plans in MCR see the phase <unk> trial is going to be winding down. We're also shifting away from our second line <unk> trial into the first line.
Mark talked about earlier on the call. So thats happening at the same time as we are ramping up our card a series or a four trial. So when we look at our overall expenses. Our net expenses going forward. We do expense, we do expect that theyre going to increase but not significantly and I think when you.
Put that together with the $81 million, we have at the end of the third quarter.
You can see once again, we bought $8 million this quarter Thats 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.
Great. Thanks very helpful.
Sure.
One moment for our next question.
Our next question comes from the line of Joe Catanzaro from Piper Sandler.
Everybody I appreciate you taking my questions, maybe just a couple from me on the <unk> four study would love to just sort of get your sense around your level of confidence.
Being able to generate these interim data by mid 'twenty four given dosing hasnt started yet im.
I'm 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 any details there would be helpful. Thanks.
Hi, Joe Yes.
We remain very bullish and being able to put out the first interim data are preliminary data from.
The trial.
As you know.
We are working very closely with Pfizer at night.
Pfizer diaper very pleased because.
Nice actually.
Conducting and implementing and executing.
Card user for randomized trial.
And so we're going off of those projections are and we do believe that we will be able to have data to talk about now keep in mind, we will be watching the trial.
The trial itself is an open label trial, so we'll be able to watch the progress of that as we as we start to enroll patients, but we do remain confident to be able to give information sometime mid next year.
Okay. That's helpful and then in terms of.
Are you still sort of data readout for my follow up there was weather.
Whether thats triggered by something formally in the protocol as it relates to sort of number of patients in the amount of follow up.
No.
Not.
It's really we're watching us.
<unk> label, So it's going to depend on the on the magnitude of the effect that we do see.
So, but there is no trigger in the protocol.
Okay got it that's very helpful. Thanks for taking my questions.
Sure Joe.
Thank you.
One moment for our next question.
Our next question comes from the line of Andy shy from William Blair.
Great. Thanks for taking my questions.
And congratulations on all the progress.
Two questions. If you don't mind, one has to do with.
Mark I believe.
What you are conducting the phase one b two study before there was a strategy employed to kind of minimize the.
The adverse events from.
Kind of switching between bullet five SBU and infusion.
Just curious if that strategy is also being employed in Florida.
<unk> is just over five.
And then look to here obviously with this.
The expanded pipeline development plan look to hear your thoughts.
Strategy.
In terms of market exclusivity. Thank you.
Okay. The first question regarding.
Regarding the bolus.
We're continuing to have that be.
And optional for the the treatment arms.
And but in the control arm.
<unk> has asked that they consider to be standard of care to have five a few bullets.
But we will continue to do what we've done in the phase II trial.
Your second question, maybe Ed maybe you could repeat that again, just so I make sure I S.
After that correctly.
Thank you.
At this time I would now like to turn the conference back over to Mark Erlander for closing remarks.
Well. Thank you all for your time and this concludes our conference call and thank you once again for joining us this afternoon.
This concludes today's conference call. Thank you for participating you may now disconnect.
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Welcome to the card if 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&A session to ensure that we have ample time to address everyones questions during the Q&A.
Session, we would ask for a limit of one question and one follow up question per person.
Ask a question at that time. Please press star followed by one one on your Touchtone phone.
As a reminder, this call is being recorded today November 2nd 2023, I would now like to turn the conference call over to Kiki Patel of Gilmartin Group. Please go ahead.
Thank you operator, joining us on the call today from cards oncology, our Chief Executive Officer, Mark or a lender and Chief Financial Officer James Levine.
During this conference call management will make forward looking statements, including without limitation statements related to guidance results and the timing of the area. So advantage of clinical trial. 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.
Curiously 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 describes in the section titled Risk factors in our annual report on Form 10-K for the year ended December 31, 2022 filed with the SEC.
March 23.
Of course oncology undertakes no duty or obligation to update any forward looking statements as a result of new information future events or changes in its effect.
Uh huh.
Slides for today's Investor call can be found in the movies and events and presentations tab on Carters oncology web site at www across oncology Dot com with that I'll turn the call over to Chief Executive Officer, Mark <unk>, Mark. Thank you <unk> and good afternoon, everyone and thank you for joining our third quarter 2023.
Financial results and the corporate update conference call.
As you can see on slide three this past quarter was transformational for Cardiff oncology in August we announced strong with data from our lead program and K Ras mutated metastatic colorectal cancer.
The conclusions from a highly supportive meeting with the FDA.
And the expansion of our relationship with Pfizer then in September we released data with two earlier stage programs in pancreatic cancer and small cell lung cancer, which included a clear efficacy signal from <unk> monotherapy in both indications.
Today, we would like to put all of this in context and explain our strategy to you all and demonstrated how we can create shareholder value going forward.
As we all know these are challenging times for publicly listed biotech companies. The Carnival oncology has a collection of strengths from which to build value.
As we list on slide four.
These include first and foremost our drug on vantage that is.
As shown clear signals of efficacy and Tolerability in combination with chemotherapy and as a single agent in our clinical trials across multiple indications.
Second an advance of chip is the only <unk> one specific inhibitor in clinical development.
Meaning on the answer to it is the first in class molecule for this well understood target for cancer therapies.
Third on vans or Tim can combine synergistically with and is well tolerated in many first line and second line standard of care regimen.
This enabled 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.
We have clear third party support for our plan and this includes the FDA and BARDA.
And finally, we have the financial resources to pursue our strategy in a thoughtful and methodical manner with the cash runway into 2020.
As we go to slide five we show three 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 and 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 Carter zero, therefore clinical trial in mid 2024.
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 that <unk> inhibition has an even larger role to play in cancer therapy.
As we have our other clinical programs.
We'll 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 third quarter 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 six here, we're summarizing the key accomplishments during the third quarter of our lead program in metastatic colorectal cancer.
As you as you know in August we shared a series of findings from our second line based on the two clinical trial and K Ras mutated metastatic colorectal cancer.
About a quarter of the patients who came into our second line trial were not treated with debit super map or bad in their prior first line treatments.
For this bev nave patients we saw strong responses to the combination of our drug Advancer too with the second line standard of care, which includes Beth.
Specifically, 73% of Bev naive patients had a confirmed objective response to treatment.
Versus historical controls that have demonstrated right around 25%.
And these patients also remained on our trial for a median time of 15 months before their disease progressed versus historical controls of seven to eight months.
We were highly encouraged by these data, which suggested that there was a new mechanism of action on vansittart.
But that was previously unknown.
Observing a threefold increase in response rate.
Doubling and the median PFS and Bev nave patients was a signal to swap for us Paul.
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 bolt on to answer Tim and Beth have independent mechanisms of action that worked together to restrict or tumors 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 <unk> in the Bev and the first line setting.
To answer this question.
<unk> engaged an independent research firm called templates to conduct a clinical study that analyzed tumor biopsy data from 135, K Ras mutated metastatic colorectal colorectal patients cancer patients.
This analysis showed that once patients were exposed to that in the first line setting.
The tumor genomics or changed.
And this change is consistent with generating tumor resistance to <unk> and debt in the second line setting.
We believe this explains why we observed strong positive clinical results in our phase will be to trial in the bev naive, but not the bad expose patient populations.
Now.
Armed 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 <unk> up to the first one.
Where all patients are bev naive.
And where we have the opportunity to positively impact the largest patient population of RAF mutated metastatic colorectal cancer.
We responded to the FDA suggestion by proposing a development plan with two clinical trials.
The first trial <unk> zero, therefore will provide randomized data for both efficacy and dose combination.
Then we can conduct a subsequent registrational trial.
Zero, 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 Cardiff oncology two 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 Cardiff Zero-zero for 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.
They engage the potential of each project, ensuring collaborations are mutually beneficial and align 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 Carter zero-zero for clinical trial, while importantly.
Cardiff oncology maintains all economic ownership and control of unanswered.
This month November the first group of our plan the only clinical trial sites across the United States, where part of Georgia floor 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 seven.
In September we announced signals of efficacy in metastatic pancreatic cancer from two clinical trials, which support our planned path forward in the first line setting.
The first trial part of there one as.
As you know evaluate on batches efficacy and Tolerability in the second line setting of pancreatic ductal adenocarcinoma or metastatic Peter.
From <unk>, we reported four of our 41 patients were 19% achieved an objective partial response or PR.
As of the data cutoff of September 13, 2023, three of the four patients with Prs were still awaiting their confirmatory scans.
As of today November 2nd.
One of these three patients patients <unk> has now shown the further deepening of response at their form of scan therefore, representing a confirmed PR on this trial.
We are still awaiting confirmatory scans for the remaining two patients with an unconfirmed PR who remain on treatment one for about eight months and another for over nine months.
This is much longer than historical medium progression free survival.
Survival of $3 one months for second line.
Overall for all Evaluable patients, we reported a median progression free survival of five months, which is encouraging since this approaches the benchmark of the first slide median PFS, which is five five 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 feedback we're on vansittart effects on tumors is being evaluated as a single agent as you recall from our last call. The data we presented in September showed.
Effects on tumor biomarkers with on vantage of monotherapy after only 10 days of treatment.
Because of these encouraging results that we observed to date with <unk> from both trials, we plan to move to the first line study through a new investigator initiated trial to be conducted at the Oregon Health and Science University Knight Cancer Institute.
This first slide design enables us to potentially have the greatest opportunity to impact these challenging diseases at the earliest possible stage when the chances of patients responding to treatment.
Finally, an important this approach allows us to generate data in a capital efficient manner.
In September we also presented the first look at data from an investigator initiated trial in refractory extensive stage small cell lung cancer.
The trial treats patients with on Vansittart monotherapy and is being conducted at the University of Pittsburgh Medical Center.
The first seven patients have been treated as of September 26, 2023, one had a confirmed partial response three stable disease in three progressive disease.
Seeing a confirmed partial response, which the investigator assessed as a 50% shrinkage of the tumor.
With on balance sheets of monotherapy provides a clear signal of <unk> efficacy.
This challenging disease.
Our current plans are to continue enrollment of 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 on dancer with second line standard of care Paclitaxel.
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 have discussed our ongoing programs and plans.
Our third objective to create value for our stakeholders is to investigate new therapeutic indications for him to answer Tim.
For example.
The recent discovery of the power of the <unk> Bev combination indicates that we should aggressively explore through preclinical models indications were that is FDA approved.
This includes Ras wild type colorectal cancer lung liver kidney.
Surgical and ovarian cancer.
We also know that on balance or TIB is antimitotic given that <unk>. One plays a critical role in cellular mitosis, which is the process through which a cancer cell divide from one cell to too.
There is extensive literature, suggesting the combination of two anti mitotic agents could be synergistic and.
And we have been exploring this combination in preclinical models with dramatic results.
To give one example, I will share some new preclinical data for hormone receptor positive or HR positive breast cancer.
These results are shown on slide eight.
Breast cancer is the most common form of cancer diagnosed today in the United States.
In 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 Tok one.
Paclitaxel and anti mitotic agent is a common second agent therapy, making it an ideal drug to explore in combination with <unk> in this setting.
The data on slide six shows how treatment with <unk> <unk>.
Paclitaxel and the two agents combined impacts patient derived xenograft models resistance to first line treatment with Cabo simpler in HR positive breast cancer.
We observed highly significant tumor regression with the combination with over 50% of the tumors within each model, having a complete response to the combination treatment.
As we look at this here at Cardiff Oncology, we believe these data support our broader vision for on to answer too.
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 third quarter 2023, Jamie.
Thank you Mark.
Earlier today, we issued a press release summarizing our financial results for the third quarter and on slide nine we share the financial highlights.
Can also find additional information in our Form 10-Q for the third quarter filed with the SEC earlier today.
Turning to our balance sheet cash and short term investments as of September 32023 totaled $81 4 million.
And net cash used in operating activities for the third quarter of 2023 was approximately $8 million.
Based on our current expectations and projections, we believe our cash resources are sufficient to fund operations into 2025.
With that I'll turn the call back over to Mark.
Well. Thank you thank you Jamie.
As we closed today.
We can see from the data we have generated to date.
Here to carp oncology truly believe we have a pipeline in a product.
And we have found a highly capital efficient ways to explore the efficacy signal.
And with data expected mid next year.
From our first line Ras mutated metastatic colorectal cancer trial, we have a an important near term catalysts.
From our lead program.
So while we recognize that the challenges facing the broader biotech industry.
We believe that the.
The strength of our data.
Clarity and support we received from our recent FDA meeting.
Our expansion of our relationship with Pfizer and our strong financial position clearly show that Kartik oncology has the potential to create enormous value for our stakeholders, including our shareholders and most importantly the.
The patients we intend to serve.
With that I will now open the call up for questions operator.
As a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again.
Our first question comes from the line of Marc Frahm from TD Cowen.
Thanks for taking my questions, maybe first on the clinical side.
At the last update there were three unconfirmed responses just im not sure.
Maybe some of those patients have had a chance to have a confirmatory scan in the last.
A month or two and so were any of them able to confirm.
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 to ramp up.
And some of these other Isps.
Lift on your part, but just that some of the startup as well.
Okay.
Thanks, Mark for your question so regarding the card up Jos our one pediatric trial.
As you stated we had four <unk> that we announced with one being confirmed on our September call. What we're announcing today is is continuing and following these patients and now we have a second patient who had a deepening of response in confirmed now has a confirmed PR.
We have two remaining patients who have not had their next scan one been on treatment for eight months and others been on treatment for over nine months and so.
We planned at some date in the future, we will update that trial, but thats, where we stand today.
I will now turn it to Jamie two unless.
If there's any.
More clarity you need on that.
Alright, that's very helpful. Thanks.
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 and NCR see the phase <unk> trial is going to be winding down. We're also shifting away from our second line <unk> trial into the first line.
Mark talked about earlier on the call. So that's happening at the same time as we are ramping up our card a series or a four trial. So when we look at our overall expenses. Our net expenses going forward. We do expect we do expect that theyre going to increase but not significantly and I think when you.
Put that together with the $81 million, we have at the end of the third quarter.
You can see once again, we burned $8 million this quarter Thats 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.
Okay. Thanks very helpful.
Sure.
One moment for our next question.
Our next question comes from the line of Joe Catanzaro from Piper Sandler.
Everybody I appreciate you taking my questions, maybe just a couple from me on the <unk> study would love to just sort of get your sense around your level of confidence around being able to generate these interim data by mid 'twenty four given dosing Hasnt started yet I'm 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 any details there would be helpful. Thanks.
Hi, Joe Yes.
We remain very bullish and being able to put out.
First interim data are preliminary data from from the trial.
As you know.
We are working very closely with Pfizer ignite and Pfizer diaper very pleased because.
That is actually.
Conducting and implementing and executing the.
Carl Joser four randomized trial.
And so we're going off of those projections are and we do believe that we will be able to have data to talk about now keep in mind, we will be watching the trial.
The trial itself is an open label trial. So we will be able to watch the progress of that as we as we start to enroll patients, but we do remain confident to be able to give information sometime mid next year.
Okay. That's helpful and then in terms of.
Actual sort of data readout my follow up there was.
That's triggered by something formally in the protocol as it relates to sort of number of patients in the amount of follow up.
No.
It's not.
Really we're watching is open label, so it's going to depend on the on the magnitude of the effect that we do see.
So, but there is no trigger in the protocol.
Okay got it.
Very helpful. Thanks for taking my question.
Sure Joe.
Thank you.
One moment for our next question.
Our next question comes from the line of Andy shy from William Blair.
Great. Thanks for taking my questions.
And congratulations on all the progress.
Two questions. If you don't mind, one has to do with.
Mark I believe.
What you are conducting the phase one phase two study before there was a strategy employed to kind.
To minimize the.
The adverse events from.
Kind of switching between bullet five SBU and infusion.
Just curious if that strategy is also being employed in 004 to just over five.
And then look to here.
With this expanded pipeline development plan look to hear your thoughts on the.
IP strategy.
In terms of market exclusivity. Thank you.
Okay. The first question.
Regarding the bolus.
We're continuing to have that be.
Optional for the the treatment arms.
And but in the control arm.
CA has asked that they consider to be standard of care to have a few bullets.
So, but we will continue to do what we've done in the phase one two trial.
Your second question, maybe Ed maybe you could repeat that again, just so I make sure I S.
After that correctly.
Thank you.
At this time I would now like to turn the conference back over to Mark Erlander for closing remarks.
Well. Thank you all for your time and this concludes our conference call and thank you once again for joining us this afternoon.
This concludes today's conference call. Thank you for participating you may now disconnect.