Q3 2023 CytomX Therapeutics Inc Earnings Call
Yeah.
Good day, and thank you for standing by welcome to the <unk> Therapeutics third quarter 2023 financial results.
This time, all participants are in a listen only mode.
The speaker's presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone you wouldn't hear an automated message advising him as race to a draw. Your question. Please press star. One again, please be advised that today's conference is being recorded I would now.
And the conference over to your Speaker today, Chris Ogden Senior Vice President Finance and accounting. Please go ahead.
Thank you good afternoon, and thank you for joining us before we begin I would like to remind everyone that during this call we'll be making forward looking statements.
Because forward looking statements relate to the future theyre subject to inherent uncertainties and risks that are difficult to predict and many of which are outside of our control.
Important risks and uncertainties are set forth in our most recent public filings with the SEC at SEC Gov.
We undertake no obligation to update any forward looking statements, whether as a result of new information future developments or otherwise.
Earlier. This afternoon, we issued a press release that includes a summary of our third quarter 2023 financial results and highlight recent progress at Photonics we.
We encourage everyone to read today's press release, and the associated materials, which have been filed with the SEC.
Additionally, the press release, a recording of this call and our SEC filings can be found under the investors and news section of our website.
With me on the call today is Dr. Sean Mccarthy, <unk>, Chief Executive Officer and Chairman.
<unk> will provide introductory comments I'll take Thomas' progress and key milestones before we cover our pipeline progress and financials for the third quarter.
With that I'll now turn the call over to Sean.
Thanks, Chris and good afternoon, everyone. Thanks for joining us for an update on <unk> continued progress in 2023.
At <unk>, we are highly focused on the discovery and development of novel cancer medicines, utilizing our priority therapeutic platform to localize potent biologic modalities into disease tissue via conditional activation in.
Increasing therapeutic index and offering new options for patients.
Yeah.
Given the continued challenging external environment for biotech I'd like to start with an overview of the strong fundamentals of cytogenetics today with three areas of particular focus outlining why we believe we are very well positioned as we move towards 2024 and beyond.
Firstly our pipeline.
So I'll turn it makes it's active across our pipeline in key areas of current oncology R&D.
Two of the biggest highlights recently at ESMO 2023 were new breakthroughs in the use of antibody drug conjugates and T cell engagements.
Adcs in T cell engages are poised to be therapeutic platforms with potential to transform the treatment of solid tumors.
I'm very pleased to say that for many years <unk> has been building significant expertise across these important modalities and we currently have differentiated lead programs in both areas.
Our pipeline has never been more relevant or had more potential.
2023 has been a year of intense focus and exceptional execution for <unk>.
Page for key value, creating milestones in 2024 and 2025.
Starting with CX 904, our priority T cell engaging <unk> targeting Egfr CD three.
Coming out of Venezuela last month's, there's clear momentum and increasing clinical evidence that T cell bi specifics can have a meaningful clinical impact in solid tumors.
However, our central challenge in this highly potent modality is that the majority of solid tumor targets are also expressed in normal cells.
Limiting therapeutic window.
CX 904 is designed to address this challenge for Egfr, which is one of the most highly validated and broadly expressed solid tumor targets.
CX 904 has continued to advanced through phase one and we're in the process of starting to backfill certain cohorts as we continue dose escalation.
We remain on track for initial data in the first half of 2024.
Our first in class cabin targeting priority ADC <unk> five one is on track for filing by the end of this year and phase one initiation in 2024.
<unk> one is an excellent example of cytomegalic differentiated ability to pursue novel ADC targets.
We are particularly excited about given its high expression level across multiple tumors, including colorectal cancer and its prior clinical validation as a target for cancer therapy.
We presented the full preclinical profile of CX 251 at World ADC in October and the presentation can be found on our website, we plan to execute on phase one dose escalation through 2024 and state permitting to initiate phase one expansion cohorts in 2025.
We have also continued to advance our first pro body cytokine CX 801 towards the clinic.
Six 801 is a master version of interferon Alpha <unk> for which we see enormous potential as a novel centerpiece of cancer immunotherapy in the future.
Last weekend, we presented updated preclinical data at <unk>. This presentation is also available on the <unk> website.
IND filing for this program is also anticipated by the end of the year.
Continuing in the field of cancer immunotherapy, our partner BMS is advancing the marked.
Few correlated <unk> program BMS 986 to eight eight in phase II, which.
Which includes proof of concept studies in microsatellite stable colorectal cancer and non small cell lung cancer.
BMS anticipate data will be available from this program in 2024.
Taken together our pipeline is deep star.
Relevant and poised to drive value inflexion in the near term.
The second area I would like to highlight today is our partnerships.
<unk> has created the field of protease based conditional activation more than a decade ago and there are substantial and consistent investments in our platform technology have allowed us to attract many high quality partners.
We currently have alliances with Madonna Regeneron, Astellas, and Amgen and BMS that each bring value to <unk> in the form of technical validation, increasing the reach of our platform.
Im providing non dilutive financing.
Together with our partners titled makes today has more than 15 active R&D programs.
In addition to upfront cash infusion from these partnerships and potential future product royalties. Each partnered program has the potential for near and long term cash milestone payments.
<unk> has a strong track record of earning milestones under our alliances, including most recently a $5 million payment from Astellas for our first clinical candidate nominated in the collaboration.
Thirdly, I would like to highlight our strong financial position.
Chris will review shortly how we are continuing to manage the financial resources of the company in the context of the challenging external environment.
Before handing over to Chris and continuing on the theme of fiscal discipline I would like to provide a brief update on CX two zero to nine our priority <unk> ADC targeting <unk> 71.
We've been encouraged by the antitumor activity, we've observed with <unk> United to date. However, based on current priorities, we will not be directing significant additional investment in this program in the near term.
Let me turn the call over to Chris who will walk you through our financials. Thank you Sean I am pleased to be able to share an update on our third quarter 2023 financial results with everyone today.
As of September 32023, we had $194 million in cash cash equivalents and investments.
Which includes $30 million received in July as a result of our successful and strategic private placement financing with PDF partners.
Overall cash burn in the third quarter was $16 8 million comparing to $33 9 million in the equivalent period of 2022.
The reduction in cash burn versus the same period in 2022 reflects our continued focus on disciplined capital allocation and cash management as well as increased R&D reimbursement under our collaborations.
I would also note that our cash balance of $194 million for the third quarter of this year is flat to the third quarter of 2022.
Which also highlights the company's ability to balance cost prioritization business development.
Millstones and equity financing to maintain a strong financial position and a very challenging biotech environment.
This balanced capital formation and allocation strategy has remained consistent over time and aligns well with our focus to build near and long term stakeholder value.
In terms of cash runway, we expect our current cash resources to fund operations into the second half of 2025.
This guidance does not assume any additional milestones from partnerships or any additional progress in new business development.
Now moving to revenue and operating expenses for the quarter for.
For the third quarter of 2023 revenue was $26 4 million compared to $11 1 million for the corresponding period in 2022.
Operating expense for Q3, 2023 was $23 3 million.
R&D expenses decreased $14 million from the corresponding period of 2022 to $16 4 million during the three months ended September 32023.
General and administrative expenses decreased by $3 7 million. During the three months ended September 32023 to $6 8 million compared to $10 $5 million for the corresponding period in 2022.
So you can see from these operating expense numbers, how we have continued to thoughtfully manage the company.
Now I'll turn the call back to Sean for closing remarks.
Thanks, Chris and thanks to everyone for your time this afternoon and for your interest in <unk>.
Looking ahead to 2024 and 2025 sites is very well positioned.
This is an exciting time for us and we remain highly focused on delivering our pipeline.
Our current pipeline encompasses highly relevant and diversified modalities, including T cell engages adcs and cytokines that each have their own unique contribution to make to the treatment of cancer.
Let me briefly recap of our key priorities and milestones for the remainder of 2023 and through 2024.
CX 904 continues in phase one dose escalation initial phase one data is anticipated in the first half of 2024 with the potential for a decision to initiate phase one be next year.
2051, <unk> thousand 51, IND filing is on track for this year.
We anticipate phase one dose escalation in solid tumors with known <unk> expression to commence in 2024 with metastatic colorectal cancer as a priority indication.
Similarly, CX 801 remains on track for R&D filing by the end of 2023 with clinical initiation in 2024.
Also in 2024, we expect BMS to make continued clinical progress with the <unk> pro body.
Including proof of concept studies in MSS, CRC and non small cell lung cancer.
With data anticipated to be available in 2024.
We also anticipate considerable progress across all of our collaborations as we continued drug discovery activities with Madonna Regeneron, Astellas Amgen and BMS.
I'll close by thanking our exceptional team members, who remain highly focused on making the biggest difference in the treatment of cancer.
This is an exciting moment for cytogenetics them anticipate multiple inflection points over the next 12 to 18 months as we continue our work in such important and relevant areas of oncology R&D.
With that operator, let's go ahead and open up the call for Q&A.
Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
One moment for our first question.
Our first question comes from the line of Roger song from Jefferies. Your line is open.
Great.
Thanks for that.
And taking all the questions.
So maybe let's focus on the now or.
The near term pipe.
Pipeline so.
Maybe you can let us know what is the expectation for the upcoming data in first half next year, particularly maybe any thoughts around that number of patients tumor types, you will be able to share with us.
The second part is what will be the key consideration to moving into the expansion cohort my understanding is that.
Decision well may it will be made later part of <unk> 24, with more follow up and maybe Alabama another data update.
Yes.
That's a key question that I have right now thank you.
Great, Yes, hi, Roger Thanks for the question.
So.
To take a little step back online or for let's just recap.
Our major objectives with the program so.
As I mentioned as we're coming towards the end of 2023.
We are now beginning to backfill certain cohorts.
In the dose escalation.
B.
Dose escalation is essentially being conducted in an egfr all comer.
Setting so we're enrolling patients who are expected to have egfr expression actively selecting for egfr expression, but theyre schumer types that are expected to be egfr positive.
And.
And this is phase one and as we saw at ESMO just.
Just a couple of weeks ago.
Phase one a early dose escalation and dose exploration for T cell engages needs to be done thoughtfully needs to be done.
Obviously with the principal objective of evaluating safety.
Dosing schedules for these potent agents and so that's what we're doing at our goal.
As I said next year will be too.
Analyze the phase Iia data with our partner Amgen and.
In collaboration with Amgen and make a decision on the go forward plan for phase one b it of course.
Go forward to phase one b would involve expansions into select egfr positive tumor types to really gain additional experience with the drug candidate. So we're on track with the goals we're on track with.
Our guidance of initial data from.
From phase one.
In the first half of next year.
And you are not ready at this stage to talk about a number of patients or specific tumor types that would be that would be a little premature, but we are on track and making making good progress.
Thank you maybe just a quick clarification when we see the initial data.
Is that the data set you will mate.
Expansion cohort decision or you will wait for later to make that decision. Thank you John.
Yes, that's a great question.
A little hard to say at this point.
That's where we are in that in the throws of this study.
Again, pointing back to you.
The very important updates that we saw from several companies that ESMO in this modality.
Yes.
<unk> early.
Phase one exploration of doses and schedules can take some time to get that to a place that you are ready to move into phase <unk> and of course increasingly.
We're.
We're expecting we're seeing the phase <unk> involves more than one dose.
More than one dose and schedule per project Optimus I think the the <unk>.
I'm Jen data for Todd I think illustrated that very very clearly and very very nicely.
So I think the short answer is we will see.
We will continue to collect data to make the best decision. We can as we look to transition from phase one eight phase won't be next year.
Excellent. Thank you Sean.
Thank you one moment for our next question.
And our next question comes from the line of Jade Montgomery from H C. Wainwright. Your line is open.
Hi, This is Joe Margolis from HC Wainwright and Mitchell Kapoor.
So when it comes to CX 801.
Is there any particular tumor type.
Please go ahead Sir.
2051, you mentioned.
The prime mindset.
The one type of tumors.
Yeah.
Good luck.
Yes, thanks for the question.
So.
Maybe let's start with what we what we know about interferon beta one being a <unk>.
Conditionally active interferon.
So we know that interferon has shown clinical activity in several tumor types in melanoma and renal and certain sarcomas lymphomas.
<unk>.
The goal here with 801 actually <expletive>.
Quite nicely demonstrated our safety posted the goal with 801 is to drive.
Intra tumoral.
<unk>.
Immunity antitumor immunity. So so we're looking to and as we showed in the poster that the preclinical data that we have shows that.
We are.
801 is very capable of.
Inducing.
And immunogenic phenotype <unk> and.
So in those tumor types, where <unk> is active.
Generally speaking tumors.
Our immune competence so.
Those will be obvious places for us to consider going in early clinical development.
The other.
Another thing to say here is that.
The strategy and as I think about the strategy of 801 and as also <unk>.
<unk> and our <unk> poster is that.
Mechanistically, we would absolutely expect based on preclinical studies.
Interferon Alpha localized interferon Alpha <unk> two.
Partner, very well with checkpoint inhibition and in fact, we showed some potent combination data in a poster last weekend and so in the clinical program. We would also be looking to I would say fairly quickly.
Move into the combination setting.
Which makes obvious sense to really drive.
Leverage the full immuno biology of interferon.
In checkpoint inhibitor combinations.
Let me just make one other comment on <unk> since you made the reference to <unk> as well in terms of tumor types. So.
So the strategy there is to.
Buyers are phase one enrollment into CRC, but of course that <unk> expressed one of the things we love about this target as the outcome is expressed in many many solid tumors that high levels.
We believe that there are across the five major expressing cancer types where outcome there.
Upwards of almost 300000 potential treatable patients who are Rs positive across those tumor types. So we'll be focusing in CRC, but also enrolling additional tumor types as well potentially looking for additional signals in the phase one and the phase one setting so I hope that.
Will help us.
Yes, great. Thanks.
More on that on both of those with the phase one data you plan to try and have that by the end of next year or is that more of a 2025 timeline factor is as well known clients.
Yes.
The goal right now where we're stupid focus as a company is to file the <unk> for 2051 and <unk> hundred one initiate clinical studies in 2024, I think as we said four.
For 2051, our goal is to as they get is far through phase, one and 2024 as we can.
We're not ready at this point to give any guidance on data that could take a little longer.
Okay. Thanks, so much.
You may now great.
Youre welcome.
Thank you for a moment for our next question.
Our next question comes from the line of Ed served at route from BMO Capital markets. Your line is open.
Hi, This is Luke <unk> on for <unk>. Thanks for taking my question.
Ongoing collaborations with Astellas and Regeneron can you give us an update as to how those are progressing.
Where we will see the biggest opportunity is for the mindsets of this medicine.
What types of programs you might see from those collaborations.
Yes, thanks for the question.
<unk> emphasized on the on the call, we're really thrilled to have such a.
A large number of high quality partners to work with its allowing us to expand the reach of the technology and also has been an important means of financing for the company and I think we will continue to be in the future.
Both Astellas and Regeneron are focused in the field of.
By specific Immunotherapies.
I'll work with Astellas.
Began a little earlier that deal a few years old now.
Regenerate is a more recent deal about a year old.
We did earn our first milestone in the Astellas relationship this year.
Which is very significant.
For one of the T cell engages this moving forward into IND, enabling studies.
Regeneron is still relatively early.
But it's also focused in a number of bi specific strategies, we haven't disclosed any specifics there about the kinds of bi specifics but of course, they are very strong player in that field.
Absolutely delighted to be.
To be partnering with them to be working with them.
Really great things to come.
Okay. Thank you.
Thank you one moment our next question.
Yes.
And our next question comes from the line of Andrew.
<unk> Rama from Jpmorgan Your line is open.
Alright. Thank you for taking the question. This is actually Malcolm Kunal on Florida.
Just one quick one for Matt can you have.
Have a sense, yet for which type of types of solid tumors, we will be prioritizing.
Lines of encore.
Malcolm could you repeat the first part of the question we didn't hear it clearly.
Oh, Yes, do you have a sense, yet for which which solid tumors Newell and prioritizing.
All lines.
Yes, thanks for the question.
As I mentioned in the early stages.
The program is we're in right now in phase Iia.
Where were escalating.
Flooring dosing schedule in the context of.
Yes.
Broadly speaking egfr positive tumor types.
As I put it essentially kind of Egfr positive oil camera strategy.
Gain initial experience with this with this drug candidate as we move forward into.
Phase one be next year.
Once we analyze the phase Iia data once we sit down with our partner Amgen.
There are of course, a multitude of Egfr positive tumors that we could move into depending upon what we've seen in the early part of the clinical studies studies, though.
I think.
Some of this some of them are the obvious ones like.
Yes.
One in head and neck.
To name, but two.
Could be others that will be a decision that will be taken taken in.
We will take into consideration.
<unk>.
Commercial drivers of our partner Amgen So TBD.
Great. Thank you I appreciate it.
Thank you one moment our next question.
Our next question comes from the line of Peter Lawson from Barclays. Your line is open.
Hi, This is Courtney on for Peter Thank you for taking my question I have a quick question on the CTO VI program with BMS, what should we expect in the 2024 data update how many patients. Thank you.
Yeah. Thanks for the question so BMS most recently updated at <unk>.
Their R&D day about a month ago.
And.
The update was that they are with this is with the non fee calculated <unk> priority that we hold to eight eight.
They are conducting proof.
Proof of concept trials in non small cell lung and MSS CRC that studies are ongoing.
<unk> are anticipated.
In 2024, but.
No additional details beyond that so.
We are.
Keely anticipating that data and.
They of course are in the driver's seat for data.
Disclosure and timing of any disclosures, which at this point has not been.
Has not been clarified.
Thank you.
Youre welcome.
Thank you I'm not showing any further questions at this time I would like to turn the conference back to Dr. Sean Mccarthy for closing remarks.
Great. Thanks, very much and thanks, everyone for your time today and for your interest in Cytogenetics.
This update on our broad company progress Thats been helpful. Please feel free to reach out to our Investor Relations team should you have any questions and have a great rest of the day.
Okay.
This concludes today's conference call. Thank you for participating you may now disconnect everyone have a great day.
Okay.
Okay.
Yeah.
[music].
Okay.
Okay.
Okay.