Q3 2022 CytomX Therapeutics Inc Earnings Call
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Good day, and thank you for standing by.
Welcome to the.
Sorry next therapeutics third quarter 2022 financial results call.
At this time all participants in all participants are in 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 on your phone you will then hear an automated message advising your hand is raised please be advised that today's conference is being recorded.
Now I'd like to hand, the conference call over to you today Speaker, Chris Ogden Senior Vice President of Finance and accounting.
The floor is yours.
Thank you good afternoon, and thank you for joining us.
Before we begin I would like to remind everyone that during this call we will 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 2022 financial results and highlights recent developments at the company.
We encourage everyone to read today's press release, and the associated materials, which have been filed with the SEC.
Additionally, the press release and a recording this call 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.
Sean will provide a business and pipeline update before I walk through the financials for the third quarter.
With that let me turn the call over to Sean.
Thank you, Chris and good afternoon, everyone.
Thanks for joining us for an update on recent progress at <unk>.
Our mission at <unk> is to destroy cancer differently, and we're focused on leveraging our priority platform to deliver differentiated medicines for people with cancer.
So tobey its clinical achievements our ratings to date continue to highlight the broad applicability and scientific depth of our platform.
<unk> therapeutics are designed to achieve conditional activation of biologic therapies in tumor tissue and we now have clinical experience with this important approach in more than 500 patients.
Of whom have significantly benefited.
Importantly, we have shown the potential of the platform to improve the therapeutic window across multiple biologic modalities, including checkpoint inhibitors antibody drug conjugates T cell bi specifics and cytokines.
These achievements are the result of our deep scientific expertise and biologic masking it.
And didn't mapping the protease tumor microenvironment.
Our continuous learning in the field of conditional activation is central to our conviction that our platform and pipeline has the potential to deliver breakthrough medicines for cancer patients.
Conditional activation of biologics as an area of cancer R&D that is increasingly recognized in the industry as an important new frontier.
Localization of cancer therapy via conditional activation offers immense promise and <unk>.
<unk> is at the forefront of this field.
Innovation takes time and persistence and along the company building journey to make the biggest difference we must from time to time to take bold decisive action and prioritize the opportunities most likely to deliver a meaningful impact to patients.
Last quarter, we made the difficult decision to restructure the company in order to focus our internal resources on our wholly owned next generation pipeline and on our partnered programs.
As a result, <unk> remains strong is funded into 2025 and is well positioned for the future.
Our current pipeline spans from preclinical phase III across multiple modalities and is addressing many important areas of unmet need in oncology.
I would now like to briefly review our lead programs.
I'd like to start with our wholly owned next generation pipeline candidates, TX 2051, and VX 801.
Now for these programs, we have selected previously validated targets <unk> and interferon Alpha <unk>, respectively.
Historically been limited in their potential due to systemic toxicities.
In the molecular design of CX 2051 in six 801, we have incorporated our platform expertise and clinical learnings to optimize predicted therapeutic index in order to potentially broaden the clinical utility of these promising targets through conditional activation.
Focusing now on CX 2051.
At cabinet has been regarded as a high potential oncology target for decades.
That has been clinically validated by others.
However efforts to generate systemic anti at Cara therapeutics have to date not been successful due to toxicity and epithelial tissues.
At the World ADC Conference. During Q3, we were pleased to unveil CX 2051, as our newest conditionally activated ADC.
2051 is tailored to optimize the therapeutic index for <unk>.
<unk> expressing epithelium cancers by matching the target with payload mechanism of action and with tumor sensitivity.
We selected capped at <unk> by some rates one inhibitor as the payload for this program based on the well characterized profile of this class and the strong clinical activity observed with topo, one inhibitors adcs, including for example, the recent groundbreaking breast cancer data for Hershey.
At World ADC.
Presented for 2051 demonstrated a wide predicted therapeutic index and strong preclinical activity and tolerability in multiple preclinical models, including in colorectal cancer.
The expression profile of <unk> and the tumor sensitivity profile of the <unk> payload provide an exciting clinical path forward for this program and we anticipate filing an IND for this novel ADC in the second half of 2023.
Turning now to CX 801, our conditionally activated interferon Alpha <unk>.
The lead program within our broad efforts in the cytokine field.
Our city later this week, we will share preclinical data for CX 801, highlighting its potential to improve therapeutic window versus unmasked interferon.
Interferon Alpha <unk> is an approved immuno therapeutic that is demonstrated clinical activity in multiple cancer types.
And we believe provides a potentially superior approach to activating antitumor immune responses to IL, two IL 12, and IL 15.
It is apparent alpha stimulates antigen presenting cells to activate cytotoxic T cells, and combined effectively with checkpoint inhibition offering tremendous potential to unlock checkpoint refractory or resistant cancers.
However, the powerful anti cancer activity of interferon Alpha is thats been difficult to harness due to systemic toxicity.
For CX 801, the data to be presented at safety show a wide therapeutic index with an enhanced tolerability profile versus unmasked interferon without limiting its potency of tumor effects.
Importantly, these data also highlight CX 800 one's preferential activity in the tumor.
Microenvironment as well as the potential for synergistic effects when combined with checkpoint inhibition.
We believe <unk> has the potential to become a unique centerpiece of combination therapy for a wide range of tumor types and we aim to rapidly advance as potentially best in class program towards clinical evaluation with an IND filing targeted for the second half of 2023.
Moving on now to our clinical stage pipeline, we continue to work intensively with our partners to advance multiple property therapeutic programs.
Our work with Bristol Myers Squibb is making important progress, including with BMS 986 to 49, the priority version of <unk>.
At ESMO in September BMS presented promising updated phase one data from an ongoing phase one two study in patients with advanced cancers.
We are particularly encouraged by the safety profile and clinical activity reported from the phase one study to date.
Both as monotherapy and in combination with <unk> 249 appears to be tolerated at higher doses than standard if aluminum at clinical dosing.
Clinical activity was demonstrated in multiple tumor types, including melanoma and a particularly encouraging case study of a response in microsatellite stable colorectal cancer.
<unk> continues to be an important target and a foundational immuno oncology strategy, but <unk> four blockade has a narrow therapeutic window.
<unk> 2022 update provides continued evidence with the priority platform, enabling higher and potentially more efficacious doses of anti <unk> therapy.
BMS continues to evaluate <unk> in a randomized phase II study in combination with <unk> versus <unk>, plus <unk> in patients with advanced melanoma.
The combination is also being studied in advanced Sip as a cellular carcinoma castration resistant prostate cancer.
And in Triple negative breast cancer.
During Q3 BMS also highlighted our collaborative work on <unk> and the <unk> Webinar series.
In a presentation titled building on the legacy of <unk>.
This presentation focused on the company's portfolio of next generation anti <unk> four antibodies to which the priority strategy is a core focus.
BMS also continues to study the non correlated <unk> four targeting property BMS 986 to eight eight in phase one both as monotherapy and also in combination with <unk> in patients with advanced solid tumors.
This strategy is aimed at enhancing the clinical benefit of Epilemma map through superior APC mediated T cell priming.
BMS will be presenting a poster at <unk>. This week focused on the non master version of 288, BMS 906 to one eight.
This poster will include preclinical data for $2 eight eight the property, which continues to advance in the clinic.
We continue to be excited to be playing such an important role in BMS next generation CTO for efforts and we look forward to future clinical updates on these programs over time.
Moving on to CX, two zero to nine or <unk> 71, or transferrin receptor directed ADC partnered with Abbvie.
<unk> has long been recognized as an attractive target for cancer therapy because of its efficiency is in internalizing transporter and because it is highly expressed in many solid and hematologic tumors.
However, this target has previously been undruggable due to its expression on many normal tissues.
<unk> nine is a conditionally activated priority ADC targeted to <unk> 71.
Has demonstrated favorable tolerability and encouraging antitumor activity in phase one and subsequently has advanced into a multi cohort phase II expansion study.
Enrollment into the <unk> expansion phase is now complete and all three solid tumor types.
A data update for the squamous lung cohort is expected in the fourth quarter of 2022. Additionally.
Additionally, data from the esophageal gastroesophageal junction cancer cohort continue to mature.
We anticipate dialogue with our partner Abbvie as to the next steps for this program.
Thus far on the call we have discussed the application of our versatile technology to three biologic modalities ADC.
Adcs.
Cytokine and checkpoint inhibitors.
I would now like to move to our fourth modality T cell engaging by specific antibodies.
Localization of the powerful activity of T cell engaging <unk> is a key goal in cancer R&D and we believe our platform is very well suited to address this challenge.
In September in cancer Research, we published preclinical data demonstrating that a conditionally active by specific Egfr CD three property could expand the safety window, while maintaining anticancer activity of this potent target combination.
This work has led to the clinical candidate CX 904, and we are now well underway with phase one dose escalation for this program with the goal of assessing safety and selecting our go forward dose for subsequent expansions in Egfr positive tumor types.
CX 904 is partnered with Amgen and a global co development collaboration and we believe this T cell engaged has broad potential across many cancers, and we look forward to providing future updates.
Let me now turn the call over to Chris to provide you with a financial overview for the quarter.
Thank you Sean I am pleased to be able to share an update on our third quarter financials with you today.
<unk> remains in a strong financial position with $194 million in cash cash equivalents and investments as of September 32022, and as John mentioned earlier, the strategic restructuring announced in July extend our projected cash runway into 2025 as we continue to look.
To the long term.
Additionally, our approach in advancing both our wholly owned pipeline and collaboration programs significantly broaden the scale of value, creating opportunities for the company and provides flexibility to diligently manage our capital needs.
Given the breadth of our platform, we view the balance and leveraging both internal and external R&D as a key advantage and core to our pipeline and capital management strategy.
Now turning to the third quarter 2022 results.
For the third quarter revenue was $16 9 million compared to $17 $6 million for the corresponding period in 2021, R&D expenses increased by $1 2 million to.
To $30 4 million.
During the three months ended September 32022, compared to Q3 2021.
The increase was primarily due to restructuring expenses.
G&A expenses were $10 $5 million during the third quarter of 2022, a decrease of zero point $6 million over Q3 2021.
The decrease was mainly due to the workforce reduction and a decrease in outside consulting expenses.
With that I'll turn the call back to Sean for closing remarks.
Thanks, Chris.
In summary, the continued scientific progress at <unk> with our platform and pipeline hold substantial promise for patients the.
The translational cycle that bench to bedside to bench continues to teachers were the highest impact applications of our technology lie for the benefit of people with cancer and we remain steadfast in our commitment.
We're looking firmly ahead to 2023, a year in which we expect to see the continued realization of our vision for conditional activation as we reach key inflection points with our most mature partners advance our first T cell engagement and filed two new IND.
In the near term, we expect to provide a data update from the lung cancer cohort from the phase III study of CX <unk> two nine.
To complete our restructuring efforts.
Our unmatched experience in designing and developing conditionally activated biologics derives from our relentless efforts to destroy cast it differently.
We also continue to make clinical and preclinical progress with our valued corporate partnerships and we will continue to pursue new business development as an integral part of our corporate development strategy.
Despite challenging current market conditions, we remain firmly focused on building <unk> for the long term as a leading innovator. Thanks to everyone involved in our efforts to make the biggest difference weekend.
Operator, let's now open up the call for Q&A.
Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced please standby, while we compile the Q&A roster.
Our first question comes from Peter Lawson.
<unk> barcode.
The floor is yours.
Thanks for taking my question just on <unk>.
2029.
How much data should we expect.
Later this year.
And then I'll call it a couple of <unk>.
Thank you.
Yes, hi, Peter Thanks for the question.
I think as we've previously guided just to recap the design of the expansion cohorts involved.
Enrolment of 25 patients.
In each cohort and as we've discussed previously also the three tumor types. The three solid tumor types that we're investigating our head and neck that we've reported on previously.
Squamous non small cell lung and also.
Our softgel cancer Gastroesophageal junction cancers, and so the goal is to.
The 25 patients in each of those cohorts as we've reported we've completed enrollment.
And each we are on track to report an update for the fully enrolled cohort alone by the end of the year.
The data for esophageal Gastroesophageal junction continues to mature.
Hello discussions going with Abbvie is a.
Kind of encouraged by the data so far just curious on that.
However, given the products.
So to recap the next steps with Abbvie the way this deal is structured.
Cytogenetics is.
Running has run the expansion phase we ran the phase one we've run the expansions and.
The next stage in this alliance, which is a global co development relationship.
Is that the.
The expansion data will be assessed and then the asset.
Is.
Scheduled to go back to Abbvie per contract to run the next phase, whether that'd be a formal phase III or move into Registrational studies.
We will be having conversations with them in the coming months about the updated expansion phase data and potential next steps for the program. That's really all we can say at this point.
Got you. Thank you and then just a follow on.
Sure.
How much data when could we see the phase one data and how is enrollment going in.
What tumor types do you think youll focus.
Yeah, well, we're thrilled to be in the clinic with this program as I mentioned in my prepared remarks. This is the first <unk>.
T cell engagement that <unk> has moved.
Into clinical studies, and we think the Egfr CD three target combination has a ton of potential in egfr positive tumors of which there are many as you know.
We are in the early stages of dose escalation and I think as is.
Generally recognized in the field the goal of our phase one with these very potent modalities is too.
Firstly assess.
Carefully assess safety.
In a stepwise fashion to get to.
A recommended phase II dose to study and further expansion. So we're making good early progress we're not ready at this point to comment on timing of any any data updates.
Okay. Thank you ill get back into the queue.
Thank you one moment for our next question.
Thank you. Our next question comes from the line of <unk>.
Route.
From BMO capital markets.
The floor is yours.
Great. Thanks for taking my question, just one on sort of the CX 2029 upcoming dataset.
You highlighted.
Let's see in the third line plus squamous.
Non small cell lung cancer and I guess.
Efficacy that 18%.
Response longer duration sufficient I guess for advancement I guess, what I guess, what's success in your mind in that study and how should we think about.
Benchmarks for PFS durability.
This population thank you.
Yes, thanks for the question and answer so I'll refer you to comments we've made previously regarding.
The lung cohort we reported.
About a year ago.
18, 8% response rate in the first 16 patients enrolled.
Into the into the study.
<unk> and <unk>.
Our guidance has been pretty consistent if you look at the benchmarks in the third line setting.
In this study we've been in the post checkpoint inhibitor setting you are looking at responses to chemo that in some cases can be in the high single digits.
And to the into the double digits.
We put out 20% in the past as a response rate that would be of interest I mean of course. This is all subject to discussion with our partner as to how they would see this asset fitting into their overall pipeline.
And therapeutic landscape in terms of duration of response again, we would see four to six months of response being.
<unk>.
An accomplishment in this late line setting.
So, we'll we'll see what we get as we analyze this data in the coming months.
Great. Thank you.
Very welcome.
One moment for our next question.
Thank you for Wang.
Our next question comes from Mara Goldstein from Mizuho.
<unk> group the floor is yours. Thank.
Thank you very much.
Wanted to ask.
Excuse me for.
You're leading the early development with that and so I'm curious as to it is from the mechanics perspective, what has to happen between them.
Having data from that dataset.
What Amgen will look at and is it an achievement of an MTV like how should we think about that.
Timing perspective, and I'm also curious.
If there is any visibility on anything from the Astellas relationship.
Advancing.
At this point.
In our first.
The traction in a very similar way to the option ships. So again, it's a global co development relationship pain significant U S comprise two nine O four as we do for 2029.
We're running the phase one program, but it's a similar structure that after.
Our phase one expansion phase the program would be per contract.
<unk>.
Ready to go back to Amgen for global later stage development, and registration, which cytogenetics, having as I said an opportunity to participate commercially in the United States that we haven't.
Provided any additional.
Information or guidance regarding.
No.
What triggers that that said not disclosed at this point, but that's those are the mechanics of the deal and like I said, where we're thrilled to be in the clinic with this agent and.
Where.
In the phase one setting highly focused on as is typical for T cell engages characterizing initially the safety profile.
Over over several expansion cohorts.
Okay.
And then with regards to Astellas.
Yes.
Not a lot more to say there we're doing a lot to work with them on the T cell engagement space.
That deal is focused in T cell engages this.
Central to Astellas Io strategy, not a whole lot more I can say about that at this time.
Okay. Thank you.
Youre welcome.
Thank you one moment our next question.
Our next question.
Comes from the line of Mitchell.
Core.
With HC Wainwright the floor is yours.
Alright, Thank you for taking the questions.
Firstly I wanted to ask about the recently reported at Cam ADC data at <unk>, How do you think about that program now differently.
With this data and what are some key learnings from that preclinical data and then separately how does the prior data from other <unk> targeted therapy derisked of the path forward. If you could just comment on that as well.
Yes, Hi, Mitch Thanks for the question. So we're super excited about this program we have been interested in that Cam for.
Quite some time as you know and the 2051.
Program that we disclose at World ADC.
As a number of key features which maintenance we believe a very attractive candidate for moving towards the clinic first of all let's focus on the target. So as you as you rightly point out at Com has been studies.
In the past that actually shown to be.
An efficacious target.
For example to the data from <unk> in there.
Anti <unk>.
Infusion protein, which.
Sure very clear clinical activity.
In non muscle invasive bladder cancer now that drug because of its systemic toxicity needed to be and still open delivered locally.
So it's a great proof of concept for how target engagement with a top infusion can lead to tumor regressions and I'm very significant tumor regressions, but it's also a case study for how.
At <unk> com.
Tox infusion cannot be delivered systemically due to its toxicity.
Well because that comment is present on most epithelial normal tissues.
No.
There has also been previously and Egfr I'm, sorry, and that <unk> three by specific that was approved some years ago, which also needs to be delivered through local application because of its high.
High level of systemic toxicity so so.
So the target is validated we need to create a therapeutic window for it which is where the marketing strategy comes in with regards to the payload.
We've spent a lot of time thinking about what's the optimal payload for net <unk> targeted ADC and we've settled on the turbo one inhibitor camptothecin.
With a cleavable linker to optimize bystander effect and we think this combination of the validated target.
The high level expression on tumor tissue.
Increasing validation of <unk> inhibitors, as having activity across a wide range of tumor types as exemplified by adhere to <unk> and other experimental agents in the clinic offers enormous potential for this for this drug candidate. So the I would say that the learnings overall from the last few.
Years.
Really distill into the target being previously validated the payload be accounted <unk> inhibitor, and we look forward to pushing this into the clinic.
In 2023.
Great. Thank you and one financial question just wonder how we can expect operating expenses to trend. After the restructuring includes around year end.
Yes, I mentioned, Chris Thanks for the question.
Don't give guidance.
On phasing, but just to reiterate our cash runway guidance, we're projected into 2025.
And we're where we expected to be in terms of the restructuring we plan to be substantially complete by year end.
Youre looking at just the base Opex this quarter I would just remind you that restructuring expenses.
On an accrued basis are in those theres about $7 million there in the quarter. So you back that out you see even a nice sequential decline so.
Progress, but I'm not guiding quarter to quarter at this point.
Perfect. Thank you I really appreciate it.
Sure.
Thank you one moment for our next question.
Our next question comes from Joe Catanzaro.
From Piper.
Great. Thanks for taking my questions here, maybe just two quick ones from me I think earlier this year at the time and that probably is as a matter of update there was indication that you would look to.
Seek a partnership I'm wondering if that's still on the agenda and you still see that as an opportunity and then with regard VX 801, and interferon Alpha I'm wondering if you could point to maybe historical data with interferon alpha and whether there have been sort of typical tumor types that have shown to be responsive.
To interferon alpha thanks.
Yes, Hi, Joe Thanks for the questions regarding 2009, yes, youre right we have.
<unk>.
We have discussed previously are interested potentially finding a partner for.
Our products.
Discussions do continue there we will be having a poster update at San Antonio.
With the full phase II data.
With regards to 801.
Again, we're super excited about this program.
Followed a similar kind of strategy to what I outlined with.
The <unk> program, just a few moments ago.
Obviously, a validated molecule is known to have anti cancer activity is known to be limited by toxicities.
Sure.
A multitude of systemic toxicity toxicity, but.
Due to the mechanism of action of interferon Alpha having both anti direct anti tumor effects and also a powerful ability to activate immune cells.
We believe this has the potential to be a.
Central.
A component of combination therapies in a go forward basis.
We can harness this activity by localizing into tumor tissue.
Some of the best clinical evidence that has motivated us for this program comes from the combination study that Merck ran actually of interferon in combination with Keytruda in the melanoma setting where they saw a high or arb about 60%. They saw similar incidents. Unfortunately, a grade three four adverse events.
But this is a highly effective drug in combination with checkpoint inhibitors, we think potentially other mechanisms.
Also shown activity in other solid tumors certain hematologic tumors.
And we think there are plenty of places to go.
With 801.
In the future. So looking forward to getting that IND filed again is our one of our two wholly owned new programs on the on the future horizon.
Great. Thanks, Thanks, so much for taking my question.
My pleasure.
Thank you at this time I would like to conclude the Q&A session.
Thank you for your participation local gold conference.
Does conclude the program you may now disconnect.
The conference will begin shortly to raise your hand during Q&A you can dial one one.
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Good day, and thank you for standing by.
Welcome to the.
<unk> Therapeutics third quarter 2022 financial results call.
At this time all participation all participants are in 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 on your phone you will then hear an automotive metals advising your hand as rates. Please be advised that today's conference is being recorded.
Now I'd like to hand, the conference call over to year, today's speaker, Chris Ogden Senior Vice President of Finance and accounting.
The floor is yours.
Thank you good afternoon, and thank you for joining us.
Before we begin I would like to remind everyone that during this call we will 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 2022 financial results and highlight recent developments at the company.
We encourage everyone to read today's press release, and the associated materials, which have been filed with the SEC.
Additionally, the press release and a recording this call 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.
Sean will provide a business and pipeline update before I walk through the financials for the third quarter.
With that let me turn the call over to Sean.
Thank you, Chris and good afternoon, everyone.
Thanks for joining us for an update on recent progress at <unk>.
Our mission at <unk> is to destroy cancer differently, and we're focused on leveraging our priority platform to deliver differentiated medicines for people with cancer.
So I totally its clinical achievements our ratings to date continue to highlight the broad applicability and scientific depth of our platform.
<unk> therapeutics are designed to achieve conditional activation of biologic therapies in tumor tissue and we now have clinical experience with this important approach in more than 500 patients many of whom are significantly.
We benefited.
Importantly, we are showing the potential of the platform to improve the therapeutic window across multiple biologic modalities, including checkpoint inhibitors.
<unk> drug conjugates T cell bi specifics and cytokines.
These achievements are the result of our deep scientific expertise and biologic masking and didn't mapping the protease tumor microenvironment.
Our continuous learning in the field of conditional activation is central to our conviction that our platform and pipeline has the potential to deliver breakthrough medicines for cancer patients.
Conditional activation of biologics as an area of cost of R&D that is increasingly recognized in the industry as an important new frontier.
The localization of cancer therapy via conditional activation offers immense promise and <unk>.
<unk> is at the forefront of this field.
Innovation takes time and persistence and along the company building journey to make the biggest difference we must from time to time take bold decisive action and prioritize the opportunities most likely to deliver meaningful impact to patients.
Last quarter, we have made the difficult decision to restructure the company in order to focus our internal resources on our wholly owned next generation pipeline and on our partner programs.
As a result, <unk> remained strong as funded into 2025 and is well positioned for the future.
Our current pipeline spans from preclinical phase III across multiple modalities and is addressing many important areas of unmet need in oncology.
I'd now like to briefly review our lead programs.
I'd like to start with our wholly owned next generation pipeline candidates CX 2051, and CX 801.
Now for these programs we have selected previously validated targets <unk> and interferon Alpha <unk>, respectively that have historically been limited in their potential due to systemic toxicities.
In the molecular design of CX 2051 in six 801, we have incorporated our platform expertise and clinical learnings to optimize predicted therapeutic index in order to potentially broaden the clinical utility of these promising targets through conditional activation.
Focusing now on CX 2051.
Ed Cabinet has been regarded as a high potential oncology target for decades.
That has been clinically validated by others.
However, our efforts to generate systemic anti <unk> therapeutics have to date not been successful due to toxicity and epithelial tissues.
At the World ADC Conference. During Q3, we were pleased to unveil CX two zero pipeline as our newest conditionally activated ADC.
2051 is tailored to optimize the therapeutic index for <unk> expressing epithelium cancers by matching the target with payload mechanism of action and with tumor sensitivity.
We selected capped Athena took price on rates one inhibitor as the payload for this program based on the well characterized profile of this class and the strong clinical activity observed with <unk>, one inhibitor adcs, including for example, the recent groundbreaking breast cancer data for <unk> and her team.
At World ADC.
Presenting for <unk> 51 demonstrated a wide predicted therapeutic index and strong preclinical activity and tolerability in multiple preclinical models, including in colorectal cancer.
The expression profile of <unk> and the tumor sensitivity profile of the <unk> payload provide an exciting clinical path forward for this program and we anticipate filing an IND for this novel ADC in the second half of 2023.
Turning now to <unk> 801, our conditionally activated interferon Alpha <unk>.
Our lead program within our broad efforts in the cytokine field.
Our city later this week, we will share preclinical data for <unk> hundred one highlighting its potential to improve therapeutic window versus unmasked interferon.
Interferon Alpha <unk> is an approved immuno therapeutic has demonstrated clinical activity in multiple cancer types and.
And we believe provides a potentially superior approach to activating antitumor immune responses to IL, two IL 12, and IL 15.
Interferon alpha stimulates antigen presenting cells to activate cytotoxic T cells and combined effectively with checkpoint inhibition offers tremendous potential to unlock checkpoint refractory or resistant cancers.
However, the powerful anti cancer activity of interferon Alpha is thats been difficult to harness due to systemic toxicity.
For CX 801, the data to be presented at safety show a wide therapeutic index with an enhanced tolerability profile versus unmasked interferon without limitations prototypes tumor effects.
Importantly, these data also highlight CX 800 one's preferential activity in the tumor microenvironment as well as the potential for synergistic effects when combined with checkpoint inhibition.
We believe <unk> has the potential to become a unique centerpiece of combination therapy for a wide range of tumor types and we enter rapidly advanced as potentially best in class program towards clinical evaluation with an IND filing targeted for the second half of 2023.
Moving on now to our clinical stage pipeline, we continue to work intensively with our partners to advance multiple property types of day programs.
Our work with Bristol Myers Squibb is making important progress, including with BMS 986 to 49 that priority version of <unk>.
At ESMO in September BMS presented promising updated phase one data from an ongoing phase <unk> study in patients with advanced cancers.
We are particularly encouraged by the safety profile and clinical activity reported from the phase one study to date.
Both as monotherapy and in combination with <unk> 249 appears to be tolerated at higher doses than standard if aluminum at clinical dosing.
Clinical activity was demonstrated in multiple tumor types, including melanoma and a particularly encouraging case study of a response in microsatellite stable colorectal cancer.
<unk> continues to be an important target and a foundational immuno oncology strategy, but <unk> four blockade has a narrow therapeutic window.
<unk> 2022 update provides continued evidence with the property platform, enabling higher and potentially more efficacious doses of anti <unk> therapy.
BMS continues to evaluate <unk> in a randomized phase II study in combination with <unk> versus <unk>, plus <unk> in patients with advanced melanoma.
The combination is also being studied in advanced Sip cellular carcinoma, castration resistant prostate cancer and triple negative breast cancer.
During Q3 BMS also highlighted our collaborative work on <unk> four and the C Webinar series.
In a presentation titled building on the legacy of <unk>.
This presentation focused on the company's portfolio of next generation anti <unk> four antibodies to waste <unk> strategy is a core focus.
BMS also continues to study the non fuel cost related Cta for targeting property BMS 986 to eight eight in phase one both as monotherapy and also in combination with <unk> in patients with advanced solid tumors.
This strategy is aimed at enhancing the clinical benefit of <unk> <unk>.
Superior APC mediated T cell priming.
BMS will be presenting a poster at 50. This week focused on the non master version of 288, BMS 986 to one eight and this poster will include preclinical data for $2 eight eight the property, which continues to advance in the clinic.
We continue to be excited to be playing such an important role in BMS next generation CCI for efforts and we look forward to future clinical updates on these programs over time.
Moving on to CX, two zero to nine or <unk> 71, or transferrin receptor directed ADC partnered with Abbvie.
<unk> has long been recognized as an attractive target for cancer therapy because of its efficiency is in internalizing transporter and because it is highly expressed in many solid and hematologic tumors.
However, this target has previously been undruggable due to its expression on many normal tissues.
<unk> is a conditionally activated <unk> ADC targeted to <unk> 71 that has demonstrated favorable tolerability and encouraging antitumor activity in phase one and subsequently has advanced into a multi cohort phase II expansion study.
Enrollment into the <unk> expansion phase is now complete and all three solid tumor types.
A data update for the squamous lung cohort is expected in the fourth quarter of 2022. Additionally.
Additionally, data from the esophageal gastroesophageal junction cancer cohort continue to mature.
We anticipate dialogue with our partner Abbvie as to the next steps for this program.
Thus far on the call we have discussed the application of our versatile technology to three biologic modalities ADC.
<unk> Adcs.
<unk> and checkpoint inhibitors.
I would now like to move to our fourth modality T cell engaging by specific antibodies.
Localization of the powerful activity of T cell engaging <unk> is a key goal in cancer R&D and we believe our platform is very well suited to address this challenge.
In September in cancer Research, we published preclinical data demonstrating that a conditionally active by specific Egfr CD three priority could expand the safety window, while maintaining anticancer activity of this potent target combination.
This work has led to the clinical candidate CX 904, and we are now well underway with phase one dose escalation for this program with the goal of assessing safety and selecting our go forward dose was subsequently expansions in Egfr positive tumor types.
CX 904 is partnered with Amgen and a global co development collaboration and we believe this T cell engaged has broad potential across many cancers, and we look forward to providing future updates.
Let me now turn the call over to Chris to provide you with a financial overview for the quarter.
Thank you Sean I am pleased to be able to share an update on our third quarter financials with you today.
<unk> remains in a strong financial position with $194 million in cash cash equivalents and investments as of September 32022, and as John mentioned earlier, the strategic restructuring announced in July extend our projected cash runway into 2025 as we continue to look.
To the long term.
Additionally, our approach in advancing both our wholly owned pipeline and collaboration programs significantly broaden the scale of value, creating opportunities for the company and provides flexibility to diligently manage our capital needs.
Given the breadth of our platform, we view the balance and leveraging both internal and external R&D as a key advantage and core to our pipeline and capital management strategy.
Now turning to the third quarter 2022 results.
For the third quarter revenue was $16 9 million compared to $17 $6 million for the corresponding.
Spending period in 2021, R&D expenses increased by $1 2 million.
To $30 4 million.
During the three months ended September 32022, compared to Q3 2021, the increase was primarily due to restructuring expenses.
G&A expenses were $10 $5 million during the third quarter of 2022, a decrease of zero point $6 million over Q3 2021.
The decrease was mainly due to the workforce reduction and a decrease in outside consulting expenses.
With that I'll turn the call back to Sean for closing remarks.
Thanks, Chris.
In summary, the continued scientific progress at <unk> with our platform and pipeline hold substantial promise for patients.
The translational cycle that bench to bedside to bench continues to teachers were the highest impact applications of our technology lie for the benefit of people with cancer and we remain steadfast in our commitment.
We're looking firmly ahead to 2023 are you hearing, which we expect to see the continued realization of our vision for conditional activation as we reach key inflection points with our most mature partners advanced software T cell engagement and filed two new IND.
In the near term, we expect to provide a data update from the lung cancer cohort from the phase II study of CX <unk> two nine.
And to complete our restructuring efforts.
Our unmatched experience in designing and developing conditionally activated biologics derives from our relentless efforts to destroy cast it differently.
We also continue to make clinical and preclinical progress with our valued corporate partnerships and we will continue to pursue new business development as an integral part of our corporate development strategy.
Despite challenging current market conditions, we remain firmly focused on building <unk> for the long term as a leading innovator. Thanks to everyone involved in our efforts to make the biggest difference we can.
Operator, let's now open up the call for Q&A.
Thank you at.
At this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one one on your telephone.
And wait for your name to be announced.
Please standby, while we compile the Q&A roster.
Our first question comes from Peter Lawson.
<unk> barcode.
I apologize.
Okay.
Thanks for taking my question just on <unk>.
CX 2029.
How much data should we expect.
Later this year.
And then I'll call it typical.
Hello, Thank you.
Yes, Hi, Peter Thanks for the question. So I think as we've previously guided and just to recap the design of the expansion cohorts.
<unk>.
Enrollment of 25 patients in.
In each cohort and as we've discussed previously also the three tumor types to three solid tumor types that we're investigating our head and neck that we've reported on previously.
Squamous non small cell lung and also.
Our softgel cancer Gastroesophageal junction cancers, and so the goal is to.
The 25 patients in each of those cohorts as we've reported we've completed enrollment.
In each we are on track to report an update for the fully enrolled cohort along by the end of the year.
And the data for esophageal Gastroesophageal junction continues to mature.
Hello discussions going with Abbvie.
Kind of encouraged by the data so far just curious on that.
However, given the product.
So to recap the.
Next steps with Abbvie.
The way this deal is structured.
<unk> is.
Running has run the expansion phase we ran the phase one we've run the expansions and.
The next stage in this alliance, which is a global co development relationship.
Is that the.
The expansion data will be assessed and then the asset.
Is.
Scheduled to go back to Abbvie per contract to run the next phase, whether that'd be a formal phase III or move into Registrational studies.
We will be having conversations with them in the coming months about the updated expansion phase data and potential next steps with the program. That's really all we can say at this point.
Got you. Thanks, and then just finally on coal.
How much data when could we see the phase one data and how is enrollment going in.
What tumor types do you think youll end up focusing though.
Yeah, well, we're thrilled to be in the clinic with this program as I mentioned in my prepared remarks. This is the first T cell engagement that <unk> has moved into clinical studies and we think the Egfr CD three target combination has a ton of potential in egfr positive tumor.
Of which there are many as you know.
We are in the early stages of dose escalation in I think.
<unk>.
Generally recognized in the field the goal of phase one with these very potent modalities is too.
Firstly assess carefully assess safety.
Stepwise fashion to get to.
A recommended phase II dose to study and further expansion. So we're making good early progress we're not ready at this point to comment on timing of any any data updates.
Okay, Thanks, I'll get back into the queue.
Thank you one moment for our next question.
Thank you. Our next question comes from the line of <unk>.
The route.
From BMO capital markets the floor is yours.
Great. Thanks for taking the question just one on sort of the CX 2029.
<unk> dataset.
You highlighted sort of efficacy in the Stateline plus gamers.
Small cell lung cancer and I guess.
Similar efficacy that 18%.
Response longer duration sufficient I guess for advancement I guess, what's I guess what's success.
Your mind in that study and how should we think about.
Margins for PFS durability for.
This population thank you.
Yes. Thanks for the question and answer so I'll refer you to comments, we've made previously regarding the lung cohort we reported.
About a year ago. The 18, 8% response rate in the first 16 patients enrolled.
Into the into the study.
<unk> and <unk>.
Our guidance has been pretty consistent if you look at the benchmarks in the third line setting.
In this study we've been in the post checkpoint inhibitor setting you are looking at responses to chemo that in some cases can be in the high single digits.
Into the into the double digits.
We put out 20% in the past as a response rate.
Would be of interest I mean of course. This is all subject to discussion with our partner as to how they would see this asset fitting into their overall pipeline.
And in therapeutic landscape in terms of duration of response.
Again, we would see four to six months of response being.
An accomplishment in this late line setting.
So, we'll we'll see what we get as we analyze this data in the coming months.
Great. Thank you.
Very welcome.
One moment for our next question.
Yes.
Thank you for Wingo.
Our next question comes from Mara Goldstein from Mizuho group the floor is yours.
Thanks very much.
To ask.
Excuse me for.
You're leading the early development with that and so I'm curious as to it is from a mechanics perspective, what has to happen between.
Having data from that dataset.
And what Amgen will look at and is it an achievement of an MTV like how should we think about that from a timing perspective animal so curious.
If there is any visibility on anything from the Astellas relationship.
Advancing.
At this point.
In our first at the structured in a very similar way to the option ships. So again, it's a global co development relationship pain significant U S rights to 904 as we do for 2029.
We're running the phase one program and it's a similar structure that after.
A phase one b expansion phase the program would be per contract.
Im ready.
We're ready to go back to Amgen for global later stage development and registration, which Cytori makes having as I said an opportunity to participate commercially in the United States that we haven't.
Provided any additional.
Information or guidance regarding.
Yes.
What triggers that.
<unk> not disclosed at this point, but those are the mechanics of the deal and like I said, where we're thrilled to be in the clinic with this agent.
We are.
In the phase one setting highly focused on.
As is typical for T cell engages characterizing initially the safety profile.
Over several expansion cohorts.
Okay.
And then with regard to Astellas.
Yes.
Not a lot more to say there we're doing a lot of work with them on the T cell engagement space.
That deal is focused in T cell engages this.
Central to Astellas I O strategy, not a whole lot more I can say about that at this time.
Okay. Thank you.
Youre welcome.
Thank you one moment our next question.
Our next question.
Comes from the line of Mitchell.
<unk>.
With HC Wainwright the floor is yours.
Alright, Thank you for taking the questions.
Firstly I wanted to ask about the recently reported at Cam ADC data at World.
How do you think about that program now differently.
With this data and what are some key learnings from that preclinical data and then separately how does the prior data from other <unk> targeted therapy director of the path forward. If you could just comment on that as well.
Yes, Hi, Mitch Thanks for the question. So we're super excited about this program we have been interested in at <unk> four.
Quite some time as you know and the 2051.
Program that we disclosed at World ADC.
As a number of key features which maintenance we believe a very attractive candidate for moving towards the clinic first of all let's focus on the target. So as you as you rightly point out at Com has been studies.
In the past that actually shown to be.
An efficacious target.
For example to the data from assess and bio in there.
<unk>.
Anti <unk>.
Infusion protein, which.
So very clear clinical activity.
In non muscle invasive bladder cancer now that drug because of its systemic toxicity needed to be instill organ delivered locally.
So it's a great proof of concept for how target engagement with a toxin fusion can lead to tumor regressions and I'm very significant tumor regression, but it's also a case study for how.
I'd ask the outcome.
Talks infusion cannot be delivered systemically due to its toxicity.
Well because <unk> is present on most epithelial normal tissues.
No.
Theres also been previously and Egfr I'm, sorry, and that can be <unk> by specific that was approved some years ago, which also needs to be delivered through local application because of its high level of systemic toxicity. So so.
So the target is validated we need to create a therapeutic window for it which is where the masking strategy comes in with regards to the payload.
He spent a lot of time thinking about what's the optimal payload for net cabinet targeted ADC and we've settled on the total one inhibitor camptothecin with a cleavable linker to optimize bystander effect and we think this combination of the validated target.
The high level expression on tumor tissue.
Increasing validation of total one inhibitors as having activity across a wide range of tumor types as exemplified by in her two to <unk> and other experimental agents in the clinic.
Offers.
Enormous potential for this for this drug candidate so the I would say that the learnings overall from the last few years.
Really distill into the target being previously validated the payload <unk> inhibitor and we look forward to pushing this into the clinic and to <unk>.
In 2023.
Great. Thank you and one financial question just wonder how we can expect operating expenses to trend. After the restructuring includes around here yet.
Yes, Hi, Mitch this is Chris Thanks for the question.
Don't give guidance.
On phasing, but just to reiterate our cash runway guidance, we're projected into 2025.
And we're where we expected to be in terms of the restructuring we plan to be substantially complete by year end.
Youre looking at just the base Opex this quarter I would just remind you that restructuring expenses.
On an accrued basis are in those theres about $7 million there in the quarter. So you back that you see even a nice sequential decline so.
Progress, but I'm not guiding quarter to quarter at this point.
Perfect. Thank you I really appreciate it.
Sure.
Thank you one moment our next question.
Our next question comes from Joe Catanzaro.
From Piper.
Great. Thanks for taking the questions here, maybe just two quick ones from me I think earlier this year at the time and that probably is thats a map update there was indication that.
Looked at.
FICO partnership I'm wondering if that's still on the agenda and you still see that as an opportunity and then with regard.
801, and interferon Alpha I'm wondering if you could point to maybe historical data with interferon alpha and whether there have been sort of typical tumor types that have shown to be responsive to interferon alpha.
Yes, Hi, Jay Thanks for the questions regarding 2009, yes, youre right.
He has.
<unk>.
We have discussed previously are interested potentially finding a partner for.
Product Thats a map discussions do continue there we will be having a poster update at San Antonio.
With the full phase II data.
With regards to 801.
Again, we're super excited about this program.
Followed a similar kind of strategy to what I outlined with.
The <unk> program, just a few moments ago.
Obviously, a validated molecule is known to have anticancer activity is known to be limited by toxicity.
Sure.
A multitude of systemic toxicity toxicities, but.
Due to the mechanism of action of interferon Alpha having both anti direct antitumor effects and also a powerful ability to activate.
Immune cells.
We believe this has the potential to be a.
Central.
A component of combination therapies in a go forward basis, if we can harness this activity by localizing into tumor tissue.
Some of the best clinical evidence that has motivated us for this program comes from the combination study that Merck ran actually of interferon in combination with Keytruda in the melanoma setting where they saw a high or arb about 60%. They saw similar incidents. Unfortunately, a grade three four adverse events.
This is a highly effective drug in combination with checkpoint inhibitors, we think potentially other mechanisms.
Also shown activity in other solid tumors certain hematologic tumors.
We think there are plenty of places to go.
With 801.
In the future. So looking forward to getting that IND filed again is one of our two wholly owned new programs on the on the future horizon.
Great. Thanks, Thanks, so much for taking my question.
My pleasure.
Thank you at this time I would like to conclude the Q&A session.
Thank you for your participation local gold conference.
This concludes the program you may now disconnect.