Q3 2023 Exelixis Inc Earnings Call
Now like to turn the call over to your host for today, Miss Susan Hubbard Executive Vice President of Public Affairs and Investor Relations. Please proceed.
Thank you Judy and thank you all for joining us for the third quarter of 2023 financial results.
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Joining me on today's call or Mike Mccarthy, our President and CEO, Chris Center, our Chief Financial Officer, TJ, Hayley R Executive Vice President of commercial Amy Peterson, Our Chief Medical Officer Dana.
Our chief Scientific officer.
To review our progress with a third order of 2023, and it's September 30th 2023, Peter.
Peter Lamb or EVP of scientific strategy will join us for the Q and a portion of the call during.
During the call today lower for to financial measures not calculated according to generally accepted accounting.
Please refer to today's press release, which is posted on our website for an explanation of our reasons for using such non-GAAP measures as well as tables driving his bedroom.
During the course of this presentation, one will be making forward looking statements regarding future events in the future performance of the company that includes statements about possible developments regarding discovery product development regulatory commercial financial and strategic better.
<unk> the results could of course get for materials, we refer you to the documents we file from time to time.
Yeah P C, which under the heading risk factor with identify important factors that could cause actual results did your materially from those expressed by the company verbally and in writing today.
Without limitation risks and uncertainties related to product commercials that market competition regulator, where I review and approval processes conducting clinical trials.
But the applicable regulatory requirements.
Dependence on collaboration partners level of costs associated with the discovery product development business development and commercialization activity.
I was trying to call every night alright, Thank you Susan.
Everyone for joining us on the call today.
So once you've had a strong you can very accurate recorder across all components of our business.
Dispute accomplishment.
I try not to continue to grow.
Size and Patricia scope, while we are best a range of discovery and development programs to build.
So what's this pipeline of the future.
<unk> goal is to improve the standard of care for patients with cancer.
She highlights for the third one will include first stroke four minutes of the combos answered the business with continued growth in demand and revenue in the U S.
<unk> maintained its status is bleeding K I R. C C.
Third quarter of 2023 combo franchise necrotic revenues were approximately $426 million in approximately $586 million in the U S and globally respectively.
P J will update our progress in the corner and provide additional commentary on our financial and commercial activities.
Second X L. A top priority on our abuse, a deliberate a pipeline of critically and commercially differentiated medicines for large populations cancer patients with high on <unk>.
Well highlight are integrated spreading and spreading discovery development and commercialization activities.
Builds on past and recent accomplished answer your success at our upcoming are the Investor event December 12th in New York City.
Amy and data will highlight of third quarter progress at a high level today and I'm excited to have them join me M. P. J as we dive into the details in December or upcoming R. A D. J is the first we've had in many years and we look forward to the opportunity to elaborate more broadly on our strategy.
And this issue or concern for patients with cancer.
<unk> first to generate sustainable longterm value for shareholders.
Third.
Activities for being a priority is to continue to see opportunities to access clinical aspects.
This will generate differentiating data and solid tumor indications September.
September <unk> announced an exclusive license agreement granting excellent alright, developing commercialized X L 309 potential best in class small molecule inhibitor of U S. P. One what's your name.
Urged as an important target.
Salary in the context Raki did you say to choose.
And finally, the second M. As in trial took place last week at the U S District Court, Delaware. The case is now submitted.
Don't Wanna get ahead of the court by commenting or speculating that you need to push the trial for a prescription for ruling either today or in the future.
You feel very confident in the case, we presented last week and the overall strength of our combos answered it hadn't mistakes. So was that please see our press release is an hour to go for a third quarter financial results inexpensive listed corporate highlights the change of the cooler now.
Now turn the call over the <unk>.
Like for the third quarter of 2023, the company reported total revenues approximately $472 million, which included covers the editor franchise that product revenues of $426.5 million.
<unk> no product revenues were $422 $2 million and include it approximately $14 million in clinical trials sales.
As a reminder, clinical trial sales have historically been choppy between orders and we expect that to continue in future orders.
So the <unk> franchise in the third quarter of 2023 was 27, 48%.
Which increased slightly when compared to the second quarter of 2023.
Based on our goes to the net in the first nine months of 2023.
Any gross to that will be between 28 per cent and 29 per cent local your 2023.
Ah Cabometyx trade inventory increased by approximately 400 units when compared to the second quarter of 2023.
Total revenues also include or approximately $45 billion in collaboration revenues, including approximately $38 million.
Royal is earned from if the applicator on their sales of Cabozantinib and their respective territories.
Our total operating expenses for the third quarter of 2023 or approximately $490 million compared to $392 million in the second quarter of 2023 increase in total operating expenses sequentially was primarily driven by higher R&D expenses and the third order of 2023, which.
Which was primarily related to the 80 million dollar upfront payment associated with in licensing a X L. Three O Dot R.
<unk> expects decline in Q3 2023, when compared to Q2 2023.
This decline was trivial attributable to lower proxy advisory fees, partially offset by higher stock based compensation expense.
Provision for income taxes for the third quarter of 2023 was approximately $4.8 million compared with provision for income taxes are approximately $19.2 million for the second quarter of 2023.
The company reported GAAP net income of approximately $1 billion or zero cents per share on a fully diluted basis for the third order of 2023.
Third quarter net income and EPS are affected by the increase in R&D expense, primarily related to the 80 million dollar upfront payment to install it.
The company also reported non-GAAP net income of approximately $32 million or 10 cents per share on a fully diluted basis.
non-GAAP net income excludes the impact of approximately $31 million of stock based compensation expense that other related income tax effect.
Cash and investments for the quarter ended September 30th 2023 was approximately $1.9 billion. This increase the level of cash and investments supported our ongoing cash flow from operations provides excellent exists with the flexibility to invest in internal discovery activities.
To pursue external business development opportunities to expand our pipeline and allows us to return capital to our shareholders through the $550 million share repurchase program, we announced in March of this year.
The third quarter of 2023, we repurchased approximately $280 million back to look the shares at an average price of $21.08.
Since the Commentor. This program with a share repurchase program, we have repurchased approximately $345 million a X lots of shares at an average price of $20.35.
Main committed to fully executing on the $550 million share repurchase program. This year.
And finally, turning to our financial guidance for the full year 2023.
Where we are in the year, we are tightening of revenue guidance, and we're increasing a R&D and SG&A expense guidance.
The increasingly R&D expense guidance as to reflect the silica deal we announced in September. Please see sides slide 14th of our two three earnings presentation for further detail.
I'll now turn the call over to pizza.
Chris the third quarter of 2023 was a strong quarter for the Cabozantinib franchise.
<unk> continues to execute that a very high level, which has resulted in cabometyx continuing to be the number one prescribed T. K I N. R. C. C N second line H C C.
Additionally, cabometyx in combination with the bowling that remains the number one T K I plus immuno oncology combination and first line renal cell carcinoma.
In terms of the business Cabometyx T R X.
Grew 8% year over year in Q3, 2023 relative to Q3 2022.
Furthermore, the business remains strong both in terms of demand and new patient starts.
Cabometyx continue to perform well in Q3 from both the marketplace and competitive perspective.
Cabometyx again, let the T K I'd market basket into your ex sure at 38%.
As we have discussed previously the first line are 16 market is extremely competitive.
Eight Q3 was the fourth quarter, and which problematic cabometyx plus the whole amount that was the number one prescribed T K plus immuno oncology combination and first of all I know.
Positive physician experience with Cabometyx plus the whole amount.
She needs to be reinforced as we highlight and promote the 44 month long term follow up check me 90, our data with median overall survival Cabometyx first of all of that bar.
49.5 months.
Representing an improvement of 14 months over the comparator arm So limited.
With a hazard ratio of seven zero.
These data fortify the leadership position that Cabometyx has in the R. C C marketplace.
Looking forward, we are excited about the positive topline results for contact too and metastatic castration resistant prostate cancer as well as the recent data from the cabinet trial and neuroendocrine tours.
Both studies or patient population with significant unmet medical need <unk>.
Intending potential regulatory approval will provide the opportunity for continued growth or cabometyx in the coming years.
That are R&D day in December I look forward to further discussing needs to potential opportunities for the Cowboys answered a franchise.
Additionally, I'm excited to shared our events commercial perspective on our emerging pipeline assets.
Our experienced with Cabos informs our strategy and ambition <unk> X B 002 X L 309 at our pipeline as we focus on bringing drugs to market in areas that will provide significant impact patients and value to X ellipses.
With that I'll turn the call over to eight.
<unk> I want to first state how thrilled I am to be here at <unk>.
Research and clinical pipeline is fraud that was in terms of modalities and target representing a variety of development opportunities, which combined with our translational and clinical development capability provide an exciting and high potential platform for growth.
And I'm looking forward to bringing it to fruition and sharing progress at our upcoming R&D day.
Today, I will provide high level update on our clinical pipeline with the intent of going into much more detail in December let's.
Let's start with our most mature compound cabinet that ma'am.
In late August we announced positive top line data from that one.
Two phase three studies contact or too, which evaluated cabozantinib capacities of with an apple in patients with metastatic castration resistant prostate cancer or M. C. R. P T.
And cabinet, which evaluated <unk> in patients with pancreatic or extra pancreatic neuroendocrine tumors.
I'll begin briefly with contact us too.
This is a randomized open label study <unk> first and second novel hormonal therapy, or N H T and patience with M. C. R. P T.
The study has multiple primary endpoints, that's spelled P F S and the last piece.
<unk> is determined by blinded independent central radiology revealed and <unk>. One one so for example progression by PSA only with not considered a P. F F.
The best informed that that appointment.
<unk> ability was restricted to patients with Nazareth over it.
That is down only non measurable disease.
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In August we issued a press release, noting a statistically significant pff's benefit in favor of <unk> and the trend also favoring commonality, though and overall survival.
New safety signals were observed an adverse events were on par with what is expected from either Carter or a T. The amount of therapy.
Based on feedback from the F. D. A we will discuss a potential regulatory submission when the electoral results are more mature.
Also in August we announced positive results from cabinet.
His three study conducted by the alliance for clinical trials in oncology.
Study evaluated <unk> versus placebo into independently powered Calvert, one in previously treated patients with pancreatic neuroendocrine tumors or peanuts.
In patients with extra pancreatic neuroendocrine tumors or E P.
So it was really too positive phase three studies in one data were recently presented it asthma by Dr. Jennifer Chan, noting PFS hazard ratio of 0.27, and 0.45 P. Net N E T net populations respectively.
Peanut the medium P. S. Aspirin Carter was 11.4 months versus three months for placebo and.
And then E P not the medium P. S. Aspirin Carver was 8.5 months versus 3.2 months for for female.
No new safety signals were identified for Cabozantinib and we look forward to discussing these results with the F. D. A once we bring the data in house.
I will now turn to them to let them.
Our stellar O one and O two phase one b two trials are evaluating zander mono therapy.
In combination with P. One P D L. One immune checkpoint inhibition.
And also check like combinations of Zander anti P. D. One M T T L E four or leg three targeted therapy.
As you can see from the slide we have multiple expansion cohort in a variety of tumors testing b as combination.
Data generated from these cohort will serve to support expanded development for Zander.
Indeed, we previously shared early yet promising data was in the amount of therapy in patients with clear self kidney cancer or compelling endurable responses are being observed in both cabo naive and Cabo pre treated patients.
These data have been accepted as late breaking oral abstract for presentation by Doctor Monkey Pal on Friday November 10th at the international kidney cancer Symposium taken place in Nashville.
Turning now to our Registrational studies was danza enrollment continues interstellar 303 evaluating the combination of <unk> versus regular wrapping up in patients with non Amathi, hi, nine D. M. M. R refractory metastatic colorectal cancer.
The study was revised to evaluate outcomes first in patients who do not have liver metastases nonlabor, Matt or N O M followed by an evaluation in the I T T population.
The sample size for both N L M and M. L. M patients is kept to ensure adequate number other than in each of these analyses.
Stellar three or four is our phase three trial, which compares the combination of Zander, plus Nevada map to see <unk> and.
In patients with previously untreated metastatic nine Clare, south kidney cancer, and and now enrolling in multiple country and last but not least stellar 305, our faith Q3 trial, which will evaluate zander in combination with penril isn't that versus handle is not alone in patients with untreated.
P D L. One positive advanced or metastatic squamous cell carcinoma of the head and neck was just posted to clinical trials dot com and we are full gear and the site activation mode.
Given the emerging favorable activity and Tolerability profile of Zander. We believe this combination of at the end of the plus 10 Route May result in improved outcome versus single agent <unk> and has the potential to offer patients at Gmail free option.
Susan Hubbard: I would now like to turn the call over to your host for today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. Please proceed.
We're excited about the emerging data with the <unk> mono therapy and in combination with ICI.
This combined with clinical data generated with <unk> provide compelling rationale to move Zander and abroad development program that will address the patients with unmet need.
We will continue to evaluate the treatment landscape to inform the design and initiation of additional pivotal studies for Zander.
Dana Aftab: The Chief Medical Officer and Dana Aftab are Chief Scientific Officer, who will review our progress for the third quarter of 2023 and in September 30th, 2023.
All turned out to S. P 002 are antibody drug conjugate, which targets tissue factor and incorporate a modified or staten at the payload.
Unknown Executive: Peter Lamb, our EVP of Science and Big Strategy, will join us for the Q&A portion of the call. During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website for an explanation of our reasons for using such non-gap measures, as well as tables deriding these measures from our gap results.
We've initiated expansion in multiple cohorts at two different doses, which will allow us to determine the best is to take forward into Registrational studies and combinations, while also fulfilling project optimist.
Combinations with <unk> and <unk> are also underway and data here will serve to inform a broader clinical development program.
Unknown Executive: During the course of this presentation, we will be making more looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial and strategic matters. Actual events and results could of course differ materially. We refer you to the documents we filed some time to time with the FEC, which under the heading risk factors identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today.
Finally, I'm very excited about X L. 309 are recently acquired Ust want inhibitor, we anticipate bold transfer of all obligations towards the end of this year and are in the process of assessing how fast too aggressively and urgently advance this asset to Joseph percolation, both as monotherapy and in combination.
We believe this to be a best in class molecule that has the potential to not only deepen responses.
D N a damn any damaging agent or agents that inhibit D. N. A damage repair like PARP inhibitors, but also to broaden the addressable population beyond those who carry a broccoli mutation.
Unknown Executive: Continuing with our limitations, risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, clients with applicable regulatory requirements, our dependent fund collaboration partners and the level of cost associated with the discovery, product development, business development and commercialization activities.
In summary.
Dancing, a robust pipeline of molecules, while maximizing the potential benefit to patients from our flagship asset <unk>, an unmet need indications.
I'm optimistic about what we can do for patients who despite significant advances still need better treatment options and I'm very much looking forward to sharing more detailed information about our progress and the recently presented data at our D day in December and with that I'll turn the call over to <unk>.
Unknown Executive: All right, thank you Susan, and thanks to everyone for joining us on the call today. Actual success has had a strong and very active through a quarter across all components of our business. We're excited to see the capacity and potential has continued to grow, both in size and potential scope, while we advance a range of discovery and development programs to build the ex Alexis pipeline of the future.
Alright, Thanks, Amy I, just want to start off by saying how excited I am to be working with Amy is my partner and R&D.
I've known her for quite some time going back to the days when we were working with Genentech on Kobe Madness and having her here on the team now has brought a lot of energy and focus into our organization.
Unknown Executive: Our singular goal is to improve the standard of care for patients with cancer. Key highlights for the third quarter include first strong performance of the cop-up and the business with continued growth in demand and revenue in the US. Oblomatics maintained its status as the leading GKI for RCC.
We've been working together preparing for R&D day next month and I'm excited about what's in store for that event. So what you'll <unk> you'll hear from me today will be just some brief highlights of what I'm planning to discuss in greater detail next month.
Unknown Executive: Third quarter of 2023 combo franchise net product revenues were approximately $426 million in approximately $586 million in the US and globally respectively.
And the third quarter, we made solid progress toward our goals of advanced existing developing Kennedys tour 90 filings.
And advancing early discovery programs to develop any candidate status.
We are on track to file for new Ind's next year, three of which will be from existing pre I N D. Biotherapeutics programs and one of which will be for X L. 495, a new small molecule development candidate that we recently added to our pipeline.
Christian P.J.: Christian P.J.
Unknown Executive: will update our progress in the quarter to provide additional commentary on our financial and commercial activities. Second, Excel talked priority in our ideas to deliver a pipeline of clinically and commercially differentiated medicines for large populations, cancer patients with high on net medical needs. We'll highlight our integrated strategy spanning discovery, development, and commercialization activities that build on past and recent composites of success at our upcoming R&D investor event on December 12 in New York.
For our existing preclinical biotherapeutics programs, we are on track with int, enabling activities and expect to file Andrew used for three programs next year.
The first will be for X P 010, or five T for targeted antibody drug How'd, you get the carrier decided heartsick anti tubular payload, which we expected filed around mid 2024.
Unknown Executive: University, Amy and Dana will highlight our third quarter progress at a high level today and I'm excited to have them join me and PJ as we dive into the details in December. Our upcoming R&D day is the first we've had in many years and we look forward to the opportunity to elaborate more broadly on our strategy to propel the organization forward and serve more patients with cancer. All in our continued efforts to generate sustainable long-term value for shared goals.
The second I N D will be for XP six to eight or by specific antibody that targets P. D. L. One along with M. K G. Two way, which is on track for iron filings in the second half of 2024.
And the third line will be for XP 371, a tissue factor targeting antibody drug costs, you guys carry the Tobu isomerase, one inhibitor payload.
This program is on track for Iron filing in late 2024.
Unknown Executive: Third, business development activities remain a priority as we continue to see opportunities to access clinical assets, potential to generate differentiating clinical data in solid two-word indications. In September, Exelixis and Silico announced an exclusive license agreement granting Exelixis global rights to develop and commercialize Excel 309, a potential best-in-class small molecule inhibitor of USP1, which is one of the projects that have emerged as an important target for synthetic lesality in the context of BRACA and the U.S, hated tunes.
So as I mentioned earlier, we recently added X L 495 for a pipeline.
495 is a potent and selective small molecule inhibitor of P. K mid one that was generated from an internal discovery program.
Inhibition. If he came at one is synthetically lethal in the context of increased cycling the levels, which occurs across a wide range of tumors, including ovarian endometrial and colorectal.
Molecule was designed to be best in class and is tracking toward int filing around mid 2024.
In addition to these programs we expect to nominate several more development candidates from our by Therapeutics discovery programs by the end of this year.
Unknown Executive: Forth and finally, the second MSN trial took place last week at the U.S. District Court in Delaware. The case is now submitted and we don't want to get ahead of the court by commenting or speculating on any components of the trial for a potential ruling, either today or in the future. We feel very confident in the case we presented last week in the overall strength of our combo-sanited patent state.
We are currently on track to reach our stated goal of up to five new development candidates. This year, which in addition to the X 1495 will include a monoclonal antibody targeting a novel a new checkpoint pathway.
And some new antibody drug conjugates.
All of these programs represent first or best in class approaches and have the potential to meaningfully contribute toward our mission of helping cancer patients recover stronger and live longer.
Unknown Executive: So with that, please see our press release. It's an hour to go for our third quarter of financial results and an extensive list of key corporate highlights achieved in the court.
Chris: I'm now turn the call over to Chris. Thanks, Mike. For the third quarter of 2023, the company reported total revenues of approximately $472 million, which included Cobbosantin and franchise patent product revenues of $426.25 million. Cobbosettics in that product revenues were $422.2 million and included approximately $14 million in clinical trial sales. As a reminder, clinical trial sales have historically been chocked between quarters and we expect this to continue in future quarters. Gross to net for the Cobbosantin and franchise in the third quarter of 2023 was 27.28%, which increased slightly when compared to the second quarter of 2023.
And with that I'll turn the call back over to Mike Alright, Thanks, Dana and you heard on the call today extra lessons got a strong third quarter of 2023. It is moving quickly to capitalize on our home in some of the <unk>.
Excited too advanced all our efforts to help any more cancer patients as we discover and develop our pipeline up in future.
Forward to sharing our latest strategy science.
R D day in December.
Close by thanking the entire X watches T M. As a collective effort to support our discovery development and commercial activities. The team is highly motivated to achieve ambition to help you answer patience recovers stronger input longer.
The driver results every single day with clear urgency and focus to build on our last long history of innovation and collaboration.
Chris: Based on our gross to net in the first nine months of 2023, we are estimating gross to net will be between 28% and 29% for the full year of 2023. Our Cobbosettics trade inventory increased by approximately 400 units when compared to the second quarter of 2023. Total revenues also included approximately $45 million in collaboration revenues, including approximately $38 million of royalties or from its indicator on their sales of Cobbosantin and their respective territories.
Look forward to update you on our progress in the future. Thank you for your continued support and interest and extra lettuce, and we're happy to now open the call quick questions.
To ask a question during the session you won't need to press star one one on your telephone.
Well then here an automatic an automated message advising your hand is raised to withdraw your question. Please press star one one again, we ask that you. Please limit yourselves to one question you are welcome to get back into the queue.
Chris: Our total operating expenses for the third quarter of 2023 were approximately $490 million compared to $392 million in the second quarter of 2023. The increase in total operating expenses sequentially was primarily driven by higher R&D expenses in the third quarter of 2023, which was primarily related to the $80 million up from payment associated with in licensing of Excel 309. Our SNA expense declining Q3 2023 was compared to Q2 2020.
One moment for first question.
Your first question comes from the line of Michael Schmidt from Guggenheim Securities.
Hey, guys. Good afternoon, thanks for taking my questions and congrats on all the progress I just had a pipeline question regarding the upcoming stellar 001 <unk> data at the kidney conference next week could you just help set some expectations here in terms of number of patients.
Chris: III. Business decline was attributable to lower proxy advisory fees, partially offset by higher spot-based compensation expense. Provision for income taxes for the third quarter of 2023 was approximately $4.28 million, compared to a provision for income taxes for approximately $19.2 million for the second quarter of 2023. The company reported that income of approximately $1 billion or zero cents per share on a fully diluted basis for the third quarter of 2023. Third quarter of net income and EPS were impacted by the increase in R&D expense, primarily related to $80 million up from payment to and silica.
You know and how many of them will be cowboy naive how should we interpret the data coming out of the meeting and then secondly, you mentioned the upcoming R&D to a few times could you just help us again understand what to expect their in particular will you disclose any clinical data from some of the New York Calico stage.
Chris: The company also reported non-gap net income of approximately $32 million for ten cents per share on a fully diluted basis. Non-gap net income excuse the impact of approximately $31 million of stock-based compensation expense net of the related income tax effect. Cash and investments for the quarter end of September 30th 2023 was approximately $1.9 billion. This increase, the level of cash investments supported on ongoing cash flow from operations provides Exelixis with the flexibility to invest in internal discovery activities, to pursue external business development opportunities to expand our pipeline and allow us to return capital to our shareholders through the $550 million share repurchase program we announced in March of this year.
Pipeline products. Thanks, so much.
Alright, let me take the first one and we can all what kind of a second one so yeah. Thanks Micheal further question I think we're really excited about the data that continues to emerge from zander, especially in the clear cell kidney cancer cohort, there's not much I can give you and the terms of details simply because of the data is embargoed M.
Chris: During the third quarter of 2023 we repurchased approximately $218 million of Exelixis shares and an average price of $21.8. Since the commencement of this program, though the share repurchase program, we have repurchased actually $345 million of Exelixis shares and an average price of $20.35. Remain committed to fully executing on the $550 million share repurchase program this year.
The presentation is just around the corner on November 10th Uhm.
<unk> will be data that is updated around the 32 patients that we discussed before that received mono therapy in Santa So I'm looking forward to going deeper with you on that at R&D day, but that's about all I can say right now.
Okay and on the on the Army decided just again managed expectations as we talked about numerous times today, we're gonna focus on strategy in science as the main the main update for investors I wouldn't expect any new late breaking unpublished data, we have a commitment to our address.
The data to do that first so you'll see that throughout 2024 for the new compounds, we're super excited to frame hour.
Chris: And finally, turning to our financial guidance for the full year 2023. Given where we are in the year, we are tightening our revenue guidance and we are increasing our R&D and SGNA expense guidance. The increase in the R&D expense guidance is to reflect the insilical deal we announced in September. Please see side slide 14 of our 2-3 earnings presentation for further detail.
Strategy and our tactics in the context of the success, we've had with combo and how we're moving forward with the pipeline. So it will be active packed day and we're looking forward to seeing you and everybody there.
PJ: I'll now turn the call over to PJ. Thank you, Chris.
Thank you one moment for next question.
PJ: The third quarter of 2023 was a strong quarter for the Cabo Sanford and franchise. Teams continues to execute at a very high level which has resulted in cabo medics continuing to be the number one prescribed TKI in RCC and second line HCC. Additionally, cabo medics in combination with Nivolumab remains the number one TKI plus immuno-oncology combination in first line renal cell carcinose. In terms of the business, cabo medics TRX volume grew 8% year over year in Q3 2023 relative to Q3 2022.
Our next question comes from the line of <unk> Berry from Bank of America.
Hey, good evening, Thanks for taking my question [noise].
<unk> I I know you can't talk a lot about the iced tea with combo, but my question is more.
Is there any engagement with M. S N as a counterparty regarding settlement or do you feel you're operating with the counterparty unwilling to engage in settlement talks we know that settlements do occur post trial in some instances as well. So just curious to the extent you can comment on that dynamic I appreciate it. Thanks.
PJ: Furthermore, the business remains strong both in terms of demand and new patient starts. Cabo medics continue to perform well in Q3 from both a marketplace and competitive perspective. Cabo medics on again led to TKI market basket in TRX share at 38%. As we have discussed previously, the first line RCC market is extremely competitive. And Q3 was the fourth full quarter in which cabo medics plus Nivolumab was the number one prescribed TKI plus immuno-oncology combination in first line, at RPC.
Yeah, Jason things with question again, I really can't say a lot here, where you know what we are I'll put it. This way you like talking to people, we have a variety of different collaborators who would work very closely with it <unk>. It's in our culture and our D N a to be as as open.
And interactive as possible. So that goes here right. If there's a settled into the head we hope you're right living in how we view that again I think we had a really strong week last week I'm not going to get ahead of the.
<unk> they have their job to do I was super and I think the whole team was just super proud of that being able to go out there and put that <unk>.
PJ: Positive position experience with Cobometics plus Nevolumat continues to be reinforced as we highlight and promote the 44 month long-term follow-up checkmate 90 art data with median overall survival for the Cobometics plus Nevolumat arm, 49.5 months, representing an improvement of 14 months over the comparator arms to Nintendo with a hazard ratio of 0.70. These data fortify the leadership position that Cobometics has in the RCC marketplace.
Context.
Of the trial date the <unk>.
Illegalities in the context and now in the end of the court, so, but you're right things can happen when they happen and if there's a there's a sylvan opportunity will certainly sir.
Thank you <unk>.
One moment for next question.
Our next question comes from the line of Gregory <unk> from our B C capital markets.
PJ: Looking forward, we are excited about the positive top-line results for contact to and metastatic testration-resistant prostate cancer as well as the recent data from the Cabinet trial in neuroendocrine tumors. Both studies and patient populations would significant unmet medical contending potential regulatory approval will provide the opportunity for continued growth for Cobometics in the coming years. At our R&D day in December, I look forward to further discussing these two potential opportunities for the Cobbosancin of franchise.
Hey, good evening my <unk>, congrats on the progress and thanks for taking my question.
Maybe it's just a question for for Amy I know first first time hearing from Amy and Amy you've really diving diving right in to the excellent pipeline and we look forward to the data and there are D day coming up just wanted to give you an opportunity to talk a bit about the opportunities you see here with the pipeline and also perhaps some of the challenges that.
You think are are ahead of you in order to realize the value that you're talking about in the.
Portfolio the pipeline, thanks, very much I congrats again.
PJ: Additionally, I am excited to share at our event a commercial perspective on our emerging pipeline assets. Our experience with Cobbos informs our strategy and ambition for Zanzel and Nib XBO02, Exel 309 and our pipeline as we focus on bringing drugs to market in areas that will provide significant impact to patients and value to exilexists.
Alright, well thanks for the question I appreciate it and thanks for the welcome I'm really excited to be here I think one of the reasons. The main reason I'm excited to be here is because of the pipeline that we eat that X like this has and the opportunity to.
Apply my development skills, and the company's development skills into bringing these all of these assets into into the limelight and to fully develop them, where they Lauren more development, particularly excited about the <unk> I think the data that is emerging uhm is demonstrating that it's the best in class.
Unknown Executive: And with that, I'll turn the call over to you. Thanks, PJ.
Amy: I want to first state how thrilled I am to be here at Exilexist. Our research and clinical pipeline is broad, both in terms of modalities and targets, representing a variety of development opportunities which combined with our translational and clinical development capabilities, provided an exciting and high potential platform for growth. And I'm looking forward to bringing into fruition and sharing progress at our upcoming R&D day. Today, I will provide a high level update on our clinical pipeline with the intent of going into much more detail in December.
And again, we will be able to share more of that at R&D day.
And I think you are tissue factor 80, Z as differentiated from <unk> molecule in a couple of different ways, most notably in the in the payload into the tax profile should be different. So we have an opportunity is there.
And with the U S. P. One inhibitor that's in that just entering clinic. That's that's in class asset, we believe and as I mentioned in the call the opportunity to not only even the responses theme for example in combination with carbon <unk> and such it further improve those patients who might derive benefit.
Amy: Let's start with our most mature compound Kavuzetna. In late August, we announced positive top line data from not one, but two phase three studies, contact O2, which evaluated Kavuzin Nib XBO02, in patients with metastatic castration-resistant prostate cancer or MCRPC, and KavNib, which evaluated KavO in patients with pancreatic or extra pancreatic neuroendocrine tumors. I'll begin briefly with contact O2. This is a randomized, open-label study of Kavuzin Nib XBO02 versus second novel hormonal therapy or NHC, in patients with MCRPC.
Harping Hamburger, but also to broaden the accessible patient population beyond those with rocket mutations. So there's a lot of really exciting opportunities for excellence us in the future. It's hard to focus on any one of them, but I I, absolutely will be focused on each of them.
Thank you one moment for next question.
Our next question comes from the line of J Olson from Oppenheimer.
Oh, Hey, congrats on the progress and thanks for taking the question.
Amy: This study has multiple primary endpoints of both PFS and OS. PFS is determined by blinded, independent, central radiology review, and per resist 1.1. So, for example, progression by PSA only was not considered a PFS event to best Point, eligibility was restricted to patients with measurable disease, that is known only non-measurable disease was not allowed. In August, we issued a press release noting a statistically significant PFF benefit in favor of Kaboatizo and the trend also favoring Kaboatizo in overall survival. Based on feedback from the FDA, we will discuss a potential regulatory submission when the OS results are more mature.
Contact zero two can you talk about when the next O S analysis might happen.
On your modeling and then also can you file to S N da without.
O S and how would you describe clinically meaningful benefits for P. S. S. N O S. In this particular setting and where do you see cabos plus it has of fitting into the treatment landscape. Thank you.
Okay, So Amy let's take.
The first part of that question and then B B P. P. J can kind of frame the commercial opportunity at a super high level, yeah, great. Thanks, J I. Appreciate the question. So Oh, what is event driven based on current estimates we believe the final the last would occur some time in 2024, I'm really not at Liberty to talk much more about that.
As for clinical meaningfulness of P. At that yes that is the totality of the data and I'm not going to speculate on what appear that difference has to be but rather just remind people. The patients that were enrolled into the study represent a very poor prognostic group of patients either patients you must have had nazareth.
Amy: Also in August, we announced positive results from Cabinet, a phase three study conducted by the Alliance for Clinical Trials and Oncology. The study evaluated Kaboatizo versus placebo in two independently powered cohorts. One in previously treated patients with pancreatic neuroendocrine tumors or P-NAT, the other in patients with extra pancreatic neuroendocrine tumors or ET-NAT. So it was really two positive phase three studies in one. Data were recently presented at ASMO by Dr. Jennifer Chan noting PFF hazard ratio of 0.27 and 0.45 in the P-NAT and EP-NAT populations respectively.
<unk> disease and that included patients with liver disease patients with extra nodal visceral disease. So a group of patients that otherwise don't have many options available to them and well it's the totality of the data so not just improvements in pff's, but also tolerability.
And accessibility and ease of delivering the therapy and I think with that I'll, let P. J talk about the commercial opportunity great Yep. Thanks, Amy and thanks for the question J because they'd be highlighted this is an area certainly higher medical need for patients. So that's really important thing we've heard that.
Amy: In P-NAT, the median PFF hazard for Kabo was 11.4 months versus three months versus placebo. And in EP-NAT, the median PFF hazard for Kabo was 8.5 months versus 3.2 months for reports with CO. No new safety signals were identified for Kaboatinum and we look forward to discussing these results with the FDA once we bring the data in-house.
From Sarah Wells, all along you know I think if you think about how this regimen could potentially fit in.
Amy: I will now turn to Zanda Littinum. Our stellar 001 and 002 phase 1B2 trials are evaluating Zanda monotherapy, Zanda in combination with PD-1, PD-L1 and immune checkpoint inhibition, and also triplet combinations of Zanda, anti-PD-1, and CTLA-4 or LEG-3 targeted therapies. As you can see from the slide, we have multiple expansion cohorts in a variety of tumors testing these combinations. Data generated from these cohorts will serve to support expanded development for Zanda.
Right that obviously the majority of patients and the first one I met a step metastatic castration resistant prostate setting are getting in an H T. And then beyond that you've got subsequent an H T chemo.
And obviously this study addresses.
You know patients relative to a second in H T. So there's that data, but then beyond the chemo I think it's something that physicians and their patients. We hear consistently really wanted to delay in treatment. So I think.
Amy: Indeed, we previously shared early yet promising data with Zanda monotherapy in patients with clear cell kidney cancer, where compelling and durable responses are being observed in both Kabo naive and Kabo pre-treated patients. These data have been accepted as late-breaking oral abstract for presentation by Dr. Monty Palt on Friday, November 10th at the International Kidney Cancer Symposium, taking place in Nashville. Turning now to our Registration Studies with Zanda, enrollment continues in just $1.303, evaluating the combination of Zanda plus a T-Zo versus regular rapinum.
Chemo was option could potentially really help that in this setting and then also these are two novel mechanisms of action potentially again for the prostate cancer setting. So I think you know anytime there's a lot of excitement for new M O as in a dizzying setting.
Certainly you know in a setting where there's no broadly available immunotherapy agent.
Would it be a lot of excitement should just get approved for that as well. So I think you know you you would potentially see.
Amy: Inpatients with non-MSI high, non-DMMR refractory metastatic colorectal cancer. This study was revised to evaluate outcomes first in patients who do not have liver metastasis, non-liber meth or NLM, solidifying an evaluation in the ITT population. The sample size for both NLM and LM patients is capped to ensure adequate number of them in each of these analyses. Steller's 304 is our phase 3 trial which compares the combination of Zanzha plus Nouvelle map to Sumitna, and patients with previously untreated metastatic non-clear cell kidney cancer and is now enrolling in multiple countries.
<unk> used prior to chemo and across multiple lines it's therapy.
Depending on vacation.
Okay. So the question.
Thank you one moment for next question.
Our next question comes from the line Oh Ching Dang from truest.
Hi, Thank you for taking my question. This is Shane Uhm online all the <unk> I have a one question regarding about how do you view the impact of the recent.
Approval <unk> he he used to offer and you can become a problem.
Amy: And last but not least, stellar 305, our phase 2-3 trial which will evaluate Zanzha in combination with Pembrolysmab versus Pembrolysmab alone, and patients with untreated PDL-1 positive advanced or metastatic squamous cell carcinoma of the head and neck was just posted to ClinicalTrials.gov and we are full gear in site activation mode. Given the emerging favorable activity and tolerability profile Zanzha, we believe this combination of Zanzha plus Pembrolysmab may result in improved outcome versus single agent Pembrolysmab and has the potential to offer patients a chemo-free option.
Yeah, <unk> down to this job in second line or C. C, where we know the cable has a very strong presence presence. So yeah. So I wanted to ask you to do any expected they struggle with ketchup.
Ketchup significant shares opt out you know market.
How do you plan to differentiate <unk> from other jobs. Thanks.
Okay. Thanks for the question Amy P. J you wanted to check that one thanks, Yeah hygiene. Thanks for the question zoom, you're referring to the recently presented.
Amy: We're excited about the emerging data with Zanzha as monotherapy and in combination with ICI. This combined with clinical data generated with Cabo provide compelling rationale to move Zanzha into broad development program that will address patients with unmet needs. We will continue to evaluate the treatment landscape to inform the design and initiation of additional pivotal studies for Zanzha.
<unk>, So obviously no approval for that data yet with the hip inhibitor.
And really I think it's important to realizing contextualize if that study is.
Really in a later lying setting in patients who have received I owe an a T K I.
Unknown Executive: I'll turn now to XBO02, our antibody drug conjugate which targets tissue factor and incorporates a modified aura statin as the payload. We've initiated expansion in multiple cohorts at two different doses which will allow us to determine the best dose to take forward into registration studies and combinations, while also fulfilling project optimists. Combinations with Nevalamab and with Pembrolysmab are also underway and data here will serve to inform a broader clinical development program.
It was head to head with ever all of them is didn't have an O. S. Benefit you know we've had certainly a lot of discussions already with Kols. It has moved beyond about the data and you know what we really see is that having.
Likely competing and very late wines of therapy in our C. C setting predominantly with Suppositive. So we don't see.
Any significant impact with regards to to the combo business generally for our second line business.
Unknown Executive: Finally, I'm very excited about XBO309, our recently acquired USB1 inhibitor. We anticipate full transfer of all obligations towards the end of this year and are in the process of assessing how best to aggressively and urgently advance this asset through dose escalation both as monotherapy and in combination. We believe this to be a besting class molecule that has the potential to not only deepen responses to with DNA damage damaging agents or agents that inhibit DNA damage repair like parking inhibitors, but also to broaden the addressable population beyond those who carry a broad communication.
Okay. It looks like the next question Alright. Thank you. Thank you one moment for next question.
Our next question comes from the line of Andy Shane from William Blair.
Oh, great. Thank for taking our questions and Amy Congratulations on your new role and look forward to working with you.
Uhm. So first of all really pleased to see the first positive I owe containing regimented prostate cancer. So there's a lot of moving pieces in the field I'm. Just curious if you can give us a sense of what the F. D. A is looking for pertaining to two O S. Right I guess, if you look at the <unk>.
Unknown Executive: In summary, we're advancing a robust pipeline of molecules while maximizing the potential benefit to patients from our flagship asset Cabo in unmet needs indications. I'm optimistic about what we can do for patients who despite significant advances still needs better treatment options.
Piece of a four that allows for crossover sounds like they wanted to look for something along the lines of no detriment. There is the bar higher for contact go to just give it a no crossover nature. So that's a number one and then you know kind of stay within the G U space. This.
Unknown Executive: And I'm very much looking forward to sharing more detailed information about our progress and the recently presented data at our R&D day in December.
Dean: And with that, I'll turn the call over to Dean. All right. Thanks, Amy.
This morning, keynote 5640 S benefit in the adjuvant SETI.
Dean: I just want to start off by saying how excited I am to be working with Amy as my partner in R&D. I've known her for quite some time going back to the days when we were working with Genentech on COVID-19 and having her here on the team now has brought a lot of energy and focus into our organization. We've been working together preparing for R&D Day next month and I'm excited about what's in store for that event.
About your view on that regarding its impact the first line metastatic.
Market and whether you have plans just to kind of navigate through that market evolution. Thank you.
Alright, thanks so.
Let's have Amy take the first part or the first question and then P. G. I can talk about adjuvant. Okay. Yeah sure. So I appreciate the question Uhm and the complexity behind that I don't I can't pretend to say what the agency is actually looking for what I can say is that it's not inconsistent with the feedback that other <unk>.
Dean: So what you'll hear from me today will be just some brief highlights of what I'm planning to discuss in greater detail next month. Next year, three of which will be from existing pre-IND by Observe Putus programs, and one of which will be for Excel 49 by a new small molecule development candidate that we recently added to our pipeline. For our existing pre-identical by Observe Putus programs, we are on track with I&D enabling activities and expect to file I&Ds for three programs next year.
<unk> are getting and they just wanted to see some more mature Ah last data. So I'll keep you posted as that progressive state healed awesome great.
Great Hey, I'd be how're you doing thanks for the question you know with regards to the the 564 study in the adjuvant setting as you know that that data was presented originally years ago and has been on the market for some time the original Oh S hazard ratio well not mature was was quite.
Dean: The first will be for XB010, our 5T4 targeted antibody drug conjugate that carried the cytotoxic anti-tubulant payload, which we expected file around mid-2024. The second I&D will be for XB628, our by specific antibody that targets PDL1 along with MPG28, which is on track for I&D filing in the second half of 2024. And the third I&D will be for XB371, a tissue factor targeting antibody drug conjugate that carries a Togo isomerase 1 inhibitor payload. This program is on track for I&D filing in late 2024.
Impressive so to speak. So this is really no surprise I think that.
These data are positive I think it's important to remember that this sort of high risk.
Population as defined by the study is is quite small relative to the number you know patients who get a nephrectomy in a given year. So we're talking just a few thousand patients.
And I think that's already been working its way through the through the treatment algorithm with regards to those patients recurring in the first one setting. So we have a pretty good feel for that really haven't seen much of a significant impact to date you know what we do here is patients who potentially recur.
Dean: So as I mentioned earlier, we recently added Excel 495 to our pipeline. Excel 495 is a potent and selective small molecule inhibitor of Pkmit1 that was generated from an internal discovery program. Innovation of Pkmit1 is synthetically lethal in the context of increased cyclone levels, which occurs across a wide range of tumors, including ovarian, endometrial, and colorectal.
<unk> or relatively shortly after <unk> in the abdomen setting.
Many physicians you sort of think of them as is done refractory so to speak to check 0.8 ambition and often than that leads them to consider a T. K I mono therapy in the first one setting and obviously with.
Dean: Our molecule is designed to be best in class and is tracking toward I&D filing around mid-2024. In addition to these programs, we expect to nominate several more development candidates from our biotherapeutics discovery programs by the end of this year. We are currently on track to reach our stated goal of up to five new development candidates this year, which in addition to XB495 will include a monoclonal antibody targeting and novel immune checkpoint pathway, and some new antibody drug conjugates. All of these programs represent first or best in class approaches and have the potential to meaningfully contribute toward our mission of helping cancer patients recover stronger and live longer.
Cabos son, and the totality of our data, we're well positioned for those patients you know I think overall with O. S. Certainly a few more physicians were prescribed that but we really don't see get them much of a significant impact in the first one setting obviously these things take your <unk>, we we've kind of been in and out for a couple of.
Here's pretty pretty comfortable with that analysis.
Thank you P J and thank you for any further questions.
Question. Please.
<unk> one moment for next question.
Our next question comes from the line of <unk> from T D Cowan.
Dana: And with that, I'll turn the call back over to Mike. All right. Thank you, Dana.
Great. Thanks for taking my question and Uhm.
Michael Schmidt: As you heard in the call today, XLX has had a strong third quarter of 2023. It is moving quickly to capitalize on our momentum in the fourth quarter. We're excited to advance all our efforts to help many more cancer patients as we discover and develop our pipeline of the future.
This job on the case last week. My question has to do and I know you can't comment on what you think the outcome would be but can you maybe just come as the judge did give some specifics on the next steps in terms of the initial brief response <unk> in their reply brief which will do February 20th.
Michael Schmidt: We look forward to sharing our latest strategies and science at our R&D day in December. I'll close by thanking the entire XLX team for their collective efforts to support our discovery development and commercial activities. The team is highly motivated to achieve our mission to help cancer patients recover stronger and live longer. We drive from results every single day with clear urgency and focus to build on our long history of innovation and collaboration.
Maybe just kind of generically procedurally can you help us understand the timing the way you say it a little bit like does that mean that the judge has a certain amount of time after the reply briefs to they'll render a decision will give a timeline, but which will render a decision or just so we understand procedurally hope you understand things to be.
Unknown Executive: We look forward to updating you on our progress in the future.
Yeah your own thanks for the question, it's really hard for me to a whole pint upon the nuances and details there I would refer you back to the transcript to see exactly what he asked for and what he's looking for to me it seemed like pretty standard stuff with houses.
Unknown Executive: Thank you for your continued support and interest in ex-Alexis and we're happy to now open the call for questions. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. We ask that you please limit yourself to one question. You are welcome to get back into the queue.
Stuff normally works, but I wouldn't want to give you the weeds there in the details. It's just I am not an expert can be it's it's just you know.
Just want to keep it you know with what's in the public domain, what's in the transcript of naturally applying for that.
Unknown Executive: One moment for our first question.
Thank you.
One moment for next question.
Michael Schmidt: Your first question comes from the line of Michael Schmidt from Guggenheim Securities. Hey guys, good afternoon. Thanks for taking my questions and congrats on all the progress.
Our next question comes from the line of a <unk> <unk> from Jeffries.
Hi, This is Amy on credit card. Thanks, so much for taking your questions Uhm. So just a few quick ones on that number one when they'll be get longer term care ability data on it that we can compare verses combo will they be able to get a sense of this from the upcoming stellar O. One data and then number two.
Michael Schmidt: I just had a pipeline question regarding the upcoming stellar 001 Zanzha data at the kidney conference next week. Could you just help set some expectations here in terms of number of patients, you know, and how many of them will be cab on IEF? How should we interpret the data coming out of the meeting?
Uhm, given that both mono and combo efficacy data for Zander looks generally in line with kudlow, we'd love to kind of revisit uhm your internal goals here for Zander, given it sort of half life is it to replace combo and she'll have better and better.
Michael Schmidt: Secondly, you mentioned the upcoming R&D day a few times. Could you just help us again understand from what to expect there in particular? Will you disclose any kind of data from some of the New York clinical stage pipeline products? Thanks so much. Amy, take the first one and we can all find the second one. Thanks Michael for the question. I think we're really excited about the data that continues to emerge from Zanzha, especially in the clear cell kidney cancer cohort.
Better safety and efficacy profile or to expand into new indications. Thanks, so much.
Yeah sure. Thanks for the question Amy I like your name.
[laughter] as for the longer durability, I think you'll you'll you'll be able to appreciate why it is that we are excited about the end when the.
Michael Schmidt: There's not much I can give you in the terms of details simply because the data is embargoed and the presentation is just around the corner on November 10. It will be a data that is updated around the 32 patients that we discussed before that received monotherapy Zanzha. So I'm looking forward to going deeper with you on that at R&D day, but that's about all I can say right now.
After the I K C. S presentation in November 10th and if you're not able to see that then certainly at R. M. D day, where I'll go into some more detail with regard to the O one and O. Two cohorts many of those cohorts are enrolled and the data is.
Maturing, there's a number of different indications that we are assessing for support to our expanded program or expanded development program not only to give support to what we're currently doing and support for example contribution of component.
Michael Schmidt: On the R&D day side, just again, manage expectations as we talked about. I think numerous times today we're going to focus on strategy and science as the main update for investors. I wouldn't expect any new late breaking unpublished data. We have a commitment to our investigators to do that first. So you'll see that throughout 2024 for the new compounds. We're super excited to frame our strategy and our tactics in the context of the success we've had with Cabo and how we're moving forward with the pipeline. So it'll be an action-packed day. We're looking forward to seeing you and everybody there. Thank you.
Unknown Executive: One moment for our next question.
As we proceed with regulatory discussions should any of those trials be positive, but also support to expand the development of of zander into new and different indications and that's where we will also leverage cava. So.
You know I can't go into much more detail, but I will be able to probably give you. Some good examples of why we're we're pretty bullish at <unk> at this point in time, given what we know about yet relative to <unk> with regard to replacing <unk>.
For that back to like.
<unk> yeah.
Yeah, I think we've covered it pretty well I can just have you said previously to go here. It is to use exams to expand the indications combinations per line of therapy, if you will and and and.
Jason Gerberry: Our next question goes from the line of Jason Gerberi from Bank of America. Hey, good evening. Thanks for taking my question.
<unk> sensitive types of tumors <unk> indications. The goal is to is to make that opportunity for zander as as big as possible across the different dimensions that we're talking about here. So it's a it's a.
Jason Gerberry: Mike, I know you can't talk a lot about the IP with Cabo, but my question is more, is there any engagement with MSN as a counter party regarding settlement? Or do you feel you're operating with a counter party and willing to engage in settlement talks? We know that settlements do occur post trial in some instances as well. So just curious to the extent you can comment on that dynamic. I appreciate it.
Very important aspiration that we have is that you think we could help a lot more cancer patients who need better therapies across the different lines as therapy early like different combinations burgers et cetera.
Jason Gerberry: Yeah, Jason, thanks for the question. Again, I really can't say a lot here. We're, you know, we are, I'll put it this way. We like talking to people. We have a variety of different collaborators who we work very closely with. It's in our culture, it's in our DNA to be as open and interactive as possible. So, that goes here, right? If there's a settlement to be had, we won't be rate limiting and how we do it.
Thank you.
One moment for next question.
Our next question comes from the line of Sylvan Turkmen can from J M. P Securities.
Yeah. Thank you. Thanks for taking my question congrats on the corner and Amy Congrats on the new job.
I have a quick question in the press release it seems like you release that cost like 313, so the Triple X had a second O X look which did not meet the threshold. That's a statistical significance can you just comment on when the next O. S look is and what we can extrapolate from the fact that.
Jason Gerberry: We do that. Again, I think we had a really strong week last week. I'm not going to get ahead of the court. They have their job to do. I was super, and I think the whole team was just super proud about being able to go out there and put the context of the trial, the data, the legalities in the context. And, you know, it's now in the hands of the court. So, but you're right. Things can happen when they happen. And if there's a, there's a so much opportunity, we'll certainly engage there. Thank you. One moment for our next question.
The second of let's look what it did not meet the threshold what what are the prospects here and and what are the plans <unk> B R. O S spoke with respect to to filing an agent engaging with the F. D. A about these two populations I have different outcomes here in this trial. Thank you so much.
Yep. Thanks.
Mm. Thanks, Mike <unk>. So we did a press release that the there was a interim that was conducted in the third quarter data did not meet the threshold for statistical significance.
Gregory Renza: Our next question comes from the line of Gregory Renza from RBC capital markets. Hey, good evening, Mike and team congrats on the progress. And thanks for taking my question.
And so the trial will continue to the next plan analysis, which is anticipated in 2020 Ford just to remind everybody that these are.
Gregory Renza: Mike, maybe just a question for Amy. I know for the first time hearing from Amy and Amy, you've really diving, diving right in to the ex-elect this pipeline. We look forward to the data and the R&D day coming up.
Faced and I'm, not really able to provide for their precision on that at at this point in time, and so I I don't really have much more to say around that.
Okay. Thank you upgrade or we had to take the next question.
Gregory Renza: I just wanted to give you an opportunity to talk a bit about the opportunities you see here with the pipeline and also perhaps some of the challenges that you think are ahead of you in order to realize the value that you're talking about in the portfolio in the pipeline. Thanks very much and congrats again. All right. Well, thanks for the question. I appreciate it. And thanks for the welcome. I'm really excited to be here.
Thank you one moment for next question.
Our next question comes from the line of Peter Lawson from Barclays.
Great. Thanks, Thanks for taking the question, Mike You mentioned <unk> data at the R&D data R. D Day would you include kind of preclinical data around the new pipeline products.
Gregory Renza: I think one of the reasons the main reason I'm excited to be here is because of the pipeline that we that ex-elect has and the opportunity to, you know, apply my development skills and the company's development skills into bringing these all of these assets into into the limelight and to fully develop them where they weren't more development. And I'm particularly excited about the end. I think the data that is emerging is demonstrating that it's a best in class.
And then would you include timelines around data releases for 24 for the pipeline.
Thanks, Peter for the question I am for digging into the details for the December meeting Yeah. I was I was speaking to no new clinical data, you'll certainly see I think a lot of preclinical data that Dana will present in used framed the opportunities for.
Gregory Renza: And, you know, again, we'll be able to share more of that at R&D day. And I think our tissue factor ADC is differentiated from the tip depth molecule on a couple of different ways, most notably in the payload into the text profile should be different. So we have opportunities there. And with the USD one inhibitor that's in the just entering clinic, that's a best in class asset, we believe. And as I mentioned in the call, the opportunity to not only deepen the responses seen, for example, in combination with carbon confession and so to further improve those patients who might drive benefit with carbon hamburger, but also to broad and the accessible patient population beyond those with rocket mutations. So there's a lot of really exciting opportunities for excellence in the future. It's hard to focus on any one of them, but I absolutely will be focused on. Thank you. One moment for our next question.
All of the upcoming I Z candidates in D. C candidates that we've got that's relatively.
Broad and deep and you know we have a lot to share their timelines again, we'll see how that frames out I can <unk>, you're committed to presenting clinical data as it matures that is in the eyes of a holder in terms of how that works from a duration and durability point of view so stay tuned on that.
And again.
We have a very.
Deep presentation. They were pulling together right now that covers all the aspects of strategically how we how we view success and how we're gonna go about reaching us very aspiration with goals for hoping to improve the standard of care for patients with cancer and then a lot of details it really getting in the weeds on in a variety of <unk>.
<unk> that we're really excited about so looking forward to seeing you there.
Alright. Thanks.
Thank you one moment for next question.
Jay Olson: Our next question comes from the line of Jay Olson from Oppenheimer. Oh, he congrats on the progress and thanks for taking the question. For contact 0-2, can you talk about when the next OS analysis might happen based on your modeling. And then also, if you want to talk about the next OS analysis, can you file to SNDA without OS? And how would you describe clinically meaningful benefits for PFS and OS in this particular setting?
Our next question comes from the line of Chess hung from Morgan Stanley.
Thanks for taking my question can you talk about what differentiates X L 495 from other P came at one inhibitors in development and what gives you confidence that it can be best in class you know the greater selectivity potency lower risk of drug drug interactions or something else. Appreciate any color you can provide.
Sure. Thanks. Thanks for the question, Jeff is Dana So as I mentioned, that's all 495, we believed to be best in class. We don't say that lightly we have a lot of data to back that up all I really wanted to say right. Now is to stay tuned for R&D day, which is where we will be presenting a lot more data.
Jay Olson: And where do you see Cabo plus Atezo fitting into the treatment landscape? Thank you. Okay, so Amy, let's take the first part of that question, and then BVP.PJ can kind of frame the commercial opportunity to super high level. Yeah, great. Thanks, Jay. I appreciate the question. So OS is event driven based on current estimates. We believe the final OS would occur sometime in 2024. I'm really not at liberty to talk much more about that.
Oh this compound, but we didn't look at the competition and.
Pursued a very solid rationale toward developing something that was best in class and not just a.
A second follow on <unk>.
Thank you Dana.
Thank you one moment.
Jay Olson: As for clinical meaningfulness of PFS, you know, it's a totality of the data. And I'm not going to speculate on what a PFS difference has to be, but rather just remind people the patients that were enrolled into this study represent a very poor, prognostic group of patients. These are patients who must have had measurable disease. And that included patients with liver disease, patients with extra nodal, visceral disease. So a group of patients that otherwise don't have many options available to them.
Yes, one moment for next question.
Our next question comes from the line up at Sir Daryl from BMO capital markets.
Jay Olson: And, you know, it's the totality of the data. So not just improvements in PFS, but also powerability and accessibility and ease of delivering the therapy. And I think with that, I'll let PJ talk about the commercial opportunity. Great. Yeah. Thanks, Amy. Thanks for the question, Jay. I think as Amy highlighted, this is an area of certainly high on mathematical need for patients. So that's really important. We've heard that from KOLs all along.
Mmm great. Thanks for taking my question. So thank you for letting out sort of the I D. Plans 4442 license, but just wondering if you could comment at all on sort of you know the phase one assets that you have in development and maybe 420, 24, where we could see potential proof of <unk>.
<unk> and the clinic with you know just like C. D X 12.
A D U 818 O five compound and some of the other assets that you have been in fees. One early early clinical trial, I guess is sort of where we could see potential proof of concept there. Thank you.
Hi, Thanks, It's Amy I'll I'll I'll take that so we do have some other assets that are partner better in phase one and we are actively.
I'm always looking at the data and we will make database decisions on how those progress in and move forward, but those are good partnerships with R. X B 002 that is advancing into its expansion cohorts I would say yeah. We're we're in the process of understanding really proof of developed the ability and the way I.
Jay Olson: You know, I think as you think about how this regimen could potentially fit in right now, obviously, the majority of patients in the first line metastatic, metastatic castration, resistive prostate setting or getting an NHT. And then beyond that, you got subsequent NHT chemo. And obviously the study addresses, you know, patients relative to a second NHT. So there's that data. But then beyond that chemo, I think it's something that physicians and their patients.
Differentiate proof of concept from proof of 12, the 30th proof of concept you have a couple of responses and it's interesting are you hit a parked the dynamic marker and it looks like the the drug is doing something to the tissue in the in the human but you don't yet know how to move that into a pivotal study these expansion cohorts for.
Jay Olson: We here consistently really want to delay entreatment. So I think a chemo was option could potentially really help that in this setting. And then also these are two novel mechanisms of action, potentially again for the prostate cancer setting. So I think, you know, anytime there's a lot of excitement for new MOA in a disease setting. And certainly, you know, in a setting where there's no broadly available immunotherapy agent, there certainly be a lot of excitement should just get approved for that as well. So I think, you know, you would potentially see Kaboatezo used prior to chemo and cross multiple lines of therapy, depending on location. Thanks for the question. Thank you.
B 002 will actually art designs actually inform them if.
If we see a certain amount of activity how would we move into pivotal studies instead of those expansion cohorts are enrolling when they mature and when we have that date is it's just dependent on how long it takes for the responses and the durability of the responses. So you know we could have some things in 2002.
24.
And then for X L. The U S. P. One inhibitor right that is just getting started and as we transfer that anyone go through does escalation I think we'll have a better understanding of what we need to see in terms of proof of developed the ability. There I think we already have a good head start understanding the patient population that.
Most likely to respond to this sort of an agent and harnessing that knowledge in terms of our eligibility criteria will help us understand how how we might quickly move into full development with that App that then thank god.
Amy: One moment for our next question. Our next question comes from the line of Jing Deng from Truist. Hi. Thank you for taking my question. This is the line of Asthika from Truist. I have a one question regarding about how do you view the impact of the recent approval of Benzo T-Fong, which is his two RFI inhibitor from Merck. They are trying to launch this drug in the second line, RCC, where we know that Kabo has a very strong presence.
I'll stop there.
Alright. Thank you upgrade will take the next question.
Thank you one moment for next question.
Our next question comes from the line of Chris <unk> from Goldman Sachs.
Alright. This is Stephen on for Chris. Thank you for taking our questions two from US on cabinet. The data that was presented that asthma showed quite a clearer pff's benefit <unk> separate as much. So I guess in that white, how confident are you that regulators will view that data package doesn't approval dataset.
Amy: So I want to ask you, do you expect that this drug will capture significant shares of the market and how do you plan to differentiate Kabo from other drugs? Thanks. Okay. Thanks for the question. Amy, PJ, want to take that one? Thanks. Yeah. Hi, Jing. Thanks for the question. Sue, we were referring to the recently presented light spark data at Esmo. So obviously no approval for that data yet with the hip inhibitor.
And then an X L 309 recently and licensed can you speak to what gives you confidence that that could be a best in class acid among competitive U S. P. One inhibitors. Thank you.
Okay. So Amy I should take the cabinet questions in Vienna can speak to 309, yeah. Thanks further questions to you and it's an important question that bring up because the way. The study was designed is that crossover was allowed and the study wasn't blinded early due to the significant benefits.
Amy: And really, I think it's important to realize and contextualize if that study is really in a later line setting in patient to a received IO in the TKI. It was head to head with a problem. I didn't have an OS benefit. You know, we've had certainly a lot of discussions already with KOLs at Esmo beyond about the data. And, you know, what we really see is that having likely competing in very late lines of therapy in RCC setting predominantly with Sivasa. So we don't see any significant impact with regards to the Kabo business generally or our second line business. And we'll take the next question over. Thank you.
Amy: One moment for our next question.
In progression free survival that was observed and all patients at that point in time or crossed over so there's not really an expectation for survival, except for us to observe survival, whether or not that passes the symptoms of the agency will.
Is you know it's a discussion will have we're pretty optimistic given that this is such a rare disease and high unmet need in late lines of setting where patients really have nothing else available to them. So we're optimistic but you know again, we have yet to have that initial discussion.
Great <unk> yeah. Thanks for the questions Steven regarding 309, so even though that's in in license compound, we actually did quite a bit of experimental work ourselves and our own labs that molecule. We have quite a data set that that supports our statement that we believe it to be best in class and so similar to.
Andy Shay: Our next question comes from the line of Andy Shay from William Blair. So great.
What I said about X 1.95 are planning to give a lot more detailed R&D day. So just say uhm stay tuned for the update there we will see a lot more you'll get a lot more information on.
Andy Shay: Thanks for taking our questions and Amy, congratulations on your new role and look forward to working with you. So first of all, really pleased to see the first positive IO containing regimen and prostate cancer. So there's a lot of moving pieces in the field. So I'm just curious if you can give us a sense of what the FDA is looking for pertaining to OS, right? I guess if you look at the Novartis PSMA for that allows for crossover sounds like they want to look for something along the lines of no detriment there is the bar higher for contigo to just given the no crossover nature. So that's number one.
Perfect. Thanks Dana.
Thank you one moment for next question.
Our next question comes from the line of Joe Catanzaro from Piper Sandler.
Everybody. Thanks for taking my question, maybe just a quick one from me. So Amy I know you have some a D C experience in some prior roles. So just wondering how you think about the next gen <unk> tissue factor a D. C that you guys have in the pipeline.
Relative to X P O two it and maybe more generally how you think about or is that an <unk> based payloads versus toper summers based pillows and maybe how you develop these two programs sequentially. Thanks.
PJ: And you know, kind of stay within the GU space this morning keynote five six four OS benefit in the adjuvant setting curious about your view on that regarding its impact to the first line of metastatic market and whether you have plans to kind of navigate through that market evolution. Thank you. All right, thank you, Amy. So what type of Amy take the first part of the first question and then PJ can talk about Agenda, okay Amy?
Hi, Jill Thanks, very much for the question. Thanks for the welcome me up I definitely have stomach variance and agencies uhm. So with regard to the Taebo one payload I think it's it's actually an opportunity to take a molecule which.
Into tumors that both express tissue factor.
And are sensitive to tap a isomerase intermission, so not all tumors that express tissue factor are sensitive to antique <unk> like or Staten, So, adding a different payload actually allows us to potentially cast a wider net with regard to some of the tumors that we might pursue.
PJ: Yeah, sure, so I appreciate the question and the complexity behind it. I don't can't pretend to say what the agency is actually looking for. What I can say is that it's not inconsistent with the feedback that other companies are getting. And they just want to see some more mature OS data. So I'll keep you posted as that. Thank you. Great. Hey Andy, how are you doing? Thanks for the question. You know, with regards to the five six four study in the adjuvant setting, as you know that that data was presented originally years ago and it's been on the market for some time.
And of course would offer a differentiated toxicity profile when it comes to the or Staten versus.
<unk> there are certain toxicity that are similar for example, I talk but there are other toxicities, there aren't as somewhere between our payload and what you might expect from <unk> neuropathy and bleeding is not something that we would expect to see with with ours. So that the.
Payload is is different for our S. P 002, and what is with Tictac, we're already starting to have a differentiated toxicity profile. We're excited about the data that you have conducted has shown that offers us an opportunity to think about how we might bring S. P 002 forward.
PJ: The original OS hazard ratio while not mature was was quite impressive. So to speak, this is really no surprise. I think that these data were positive. I think it's important to remember that this sort of high risk population as defined by the study is quite small relative to the number, you know, patients who get an infrectomy in a given year. So we're talking just a few thousand patients and I think that's already been working its way through the through the treatment algorithm with regards to those patients recurring in the first line setting.
Into that space leveraging are differentiated toxicity profile. So I hope that answered your question.
Thank you.
Thank you one moment for next question.
Our next question comes from the line of Steven Willie from Stifel.
PJ: So we have a pretty good feel for that. Really haven't seen much of a significant impact to date. You know, what we do here is patients who potentially recur while on Pembro or relatively shortly after Pembro in the adjuvant setting. Many physicians do sort of think of them as then refractory so to speak to checkpoint inhibition and often then that leads them to consider a TKI mono therapy in the first line setting and obviously with Cabo's son and the totality of our data, we're well positioned for those patients.
Yeah. Good afternoon. Thanks for taking my questions in just a couple of quick clinical once for me so.
Stellar 305, I'm, just kind of curious I know Merck announced believe 10 trial didn't hit a ton coin. So I guess a couple of months ago and just curious how do you think about <unk>, a differentiation relative to one diamond within the setting up coming back.
Cause it may be just a quick follow up to Joe's question I know for June 101, you're not looking at cervical as part of any combination expansion cohorts and it just kind of given some other concern around combining tictac with with the overlapping the overlapping bleeding risks just kind of curious why that's not on your radar screen right now.
PJ: You know, I think overall with O.S, certainly a few more positions will prescribe that, but we really don't see much of a significant impact in the first line setting. Obviously these things take years to develop, but we've kind of been in it now for a couple of years and it's pretty pretty comfortable with that analysis. Great. Thank you, PJ. Thank you for the question.
Unknown Executive: I'm ready to move into the next question, please.
Okay.
<unk> what channel maybe maybe have a second question first just to clear up that misconception yep glad that I'm cervical cancer is in our list of expanded coverage for Jewel 101, we are absolutely investing it again and then with regard to stellar 305, what gives us confidence, even though pet lamb didn't quite hit the mark is the <unk>.
Unknown Executive: Thank you.
Unknown Executive: One moment for our next question.
Yaron Werber: Our next question comes in the line of your own Werber from TD Cowan. Great.
Data that was generated with <unk> in the study of 33 patients, where we had a 54% response rate in a P. S. At the 14th six months I think that that benchmark favorably to <unk> showed in their face too which was an L. R. R. A 36% in a PFS of $8 two months. So we're different said so.
Yaron Werber: Thanks for taking my question and nice job on the case last week. My question has to do and I know you can't comment on what you think the outcome would be, but can you maybe just comment that the judge did give some specifics on the next steps in terms of the initial briefs response briefs. And the reply briefs, which are due February 20th. Maybe just kind of generically procedurally, can you help us understand the timing the way you see it a little bit?
Yaron Werber: Does that mean that the judge has a certain amount of time after the reply briefs to then render a decision or give a timeline by which he will render a decision or just so we understand procedurally how you understand things today.
That was <unk> <unk>. This is what we're bringing forward is <unk>, which is what we believe to be a best in class and better than what we could have observed with combo and already <unk> and crossrail comparisons it looks to be better than <unk>.
Hope that answers it.
Thank you.
Thank you one moment for next question.
Our next question comes from the line of Christopher Lamb from Leerink partners.
Yaron Werber: Yeah, Yaron, thanks for the question. It's really hard for me to opine upon the nuances and details there. I would refer you back to the transcript to see exactly what he asked for and what he's looking for. To me, it seemed like pretty standard stuff with how this stuff normally works, but I wouldn't want to get into the weeds there in the detailed system. You know, with what's in the public domain, what's in the transcript and not going to apply for this?
Unknown Executive: Thank you. One moment for our next question.
Hey, guys. Thanks for thanks for the questions. So you mentioned that during the R&D that it's gonna be folks along the science just wondering if there's any color you can give us in terms of you know when we can expect to see.
Data for some of these pipeline ask that's like the tissue starts hurting or D. C to see the kids seven the U S. P. One that you recently and my son's.
Anything on that and then in terms of just a quick second question.
In terms of business development are you guys looking to.
Are you guys looking at assets that are earlier in the clinical page or or would you guys consider something later on in the clinical screamed as well.
Akash Tawari: Our next question comes from the line of Akash Tawari from Jeffries.
Yeah. Thanks for the thanks for the question was Chris It's my comments for both questions starting would there be any question first what we are very into.
Amy: Hi, this is Amy on for a car. Thanks so much for taking your questions. So just two quick ones on Zanza. Number one, when will we get longer term durability data on Zanza that we can compare versus Cabo? Will we be able to get a sense of this from the upcoming stellar 01 data? And then number two, given that both mono and combo efficacy data for Zanza looks generally in line with Cabo.
Interested looking for molecules that are clinical stage assets early stage midstage late stage that have.
Data that help us understand the potential for clinical.
Political and commercial differentiation alright, so that can be early that can be late again, we have to be we have to have the right level of conviction that what we're looking at and potentially either partnering or acquiring can really move the needle for patients because again <unk>.
Amy: So we'd love to kind of revisit your internal goals here for Zanza given its shorter half life. Is it to replace Cabo and show a better and you know better safety and efficacy profile or to expand into new indications. Thanks so much.
<unk>, that's the only way, we're gonna be able to build value I am just very.
PJ: Amy? Yeah, sure. Thanks to the question Amy. I like your name. So as for the longer durability, I think you'll you'll be able to appreciate why it is that we're excited about the end of when the. After the IK CS presentation on November 10th, and if you're not able to see that then certainly R&D day, where I'll go into more detail. With regard to the 001 and 002 cohorts, many of those cohorts are enrolled and the data is maturing.
Very competitive marketplace.
In terms of on a D D and timelines getting in the way they are probably isn't vital right now.
We handle all that in December I think it will be a great a great morning, and looking forward to having everybody. There. So we can we can frame the science with the strategy with the details help everybody see where we're going and you know how we're gonna be able to <unk> really large aspirational goes to health issues.
Thank you bye.
Thank you at this time there are no further questions and so I will turn the call over to today's host Susan Hubbard Ms Hubbard.
PJ: There's a number of different indications that we are assessing for support to our expanded program, our expanded development program not only to give support to what we're currently doing and support, for example, contribution of components. As we proceed with regulatory discussions, should you know those trials be positive, but also support to expand the development of Zanza into new and different indications. And that's where we'll also leverage Cabo. So, you know, I can't go into much more detail, but I will be able to probably give you some good examples of why we're we're pretty bullish on Zanza at this point in time given what we know about yet relative to Cabo.
Yeah. Thank you and thanks, everybody for joining US today, certainly do you have any follow up questions don't hesitate to reach out to the ear Verizon will get back to you right away.
This concludes today's conference call. Thank you for participating you may now disconnect.
Mmm.
[music] [music].
PJ: And with regard to replacing Cabo, I'll defer that back to my guard PJ. Yeah, I think you covered it pretty well. Again, just as we said, pretty just the way the goal here is to use Zanza to expand the indications, the combinations, the line of therapy, if you will. And Cabo has sensitive types of tours and indications, the goal is to make that opportunity for Zanza as big as possible across the different dimensions that we're talking about here. So, it's a very important aspiration that we have because if we think we could help a lot more cancer patients who need better therapies across the different lines of therapy, early, late, different combination partners.
Unknown Executive: Thank you.
Unknown Executive: One moment for our next question.
Silvan Tuerkcan: Our next question comes from the line of Silvan Tuerkcan from JMP Securities. Yeah, thank you. Thanks for taking my question. Congratulate quarter and Amy, congrats on the new job. I have a quick question in the press release. It seems like you released that Cosmic 313, so the triplet had a second OS look, which did not meet the threshold for stats statistical significance. Can you just comment on when the next OS look is and what we can extrapolate from the fact that, you know, the second OS look was did not meet the threshold.
Silvan Tuerkcan: What are the prospects here and what are the plans, Asim, you know, the OS look with respect to filing and engaging with the FDA about these two populations that have different outcomes here in this file. Thank you so much. Yes, thanks, Sarvan. Thanks, Mike. Thanks, Sarvan. So we did press release that there was an interim that was conducted in the third quarter. Data did not meet the threshold for statistical significance. And so the trial will continue to the next plan that analysis, which is anticipated in 2024 just to remind everybody that these are event based. And I'm not really able to provide further precision on that at this point in time. And so I don't really have much more to say around that. Great. Thank you. I'm ready.
Silvan Tuerkcan: We'll have to take the next question. Thank you.
Unknown Executive: One moment for our next question.
Peter Lawson: Our next question comes from the line of Peter Lawson from Barclays. Great. Thanks for taking the question. Mike, you mentioned no new data at the R&D data R&D day, which you include kind of preclinical data around the new pipeline products. And then will you include timelines around data releases for 24 for the pipeline? Thanks, Peter, for the question and for digging into the details for the December meeting. Yeah, I was speaking to no new clinical data.
Peter Lawson: You'll certainly see I think a lot of preclinical data that Dana will present in use to frame the opportunities for all the upcoming IED candidates and DC candidates that we've got that's relatively broad and deep. And we have a lot to share there timelines. Again, we'll see how that frames out. And again, we're committed to presenting clinical data as it would sure is that is in the eyes of a holder in terms of how that looks from a duration and durability point of view.
Peter Lawson: So stay tuned on that. And again, we have a very deep presentation that we're pulling together right now that covers all the aspects of strategically. So we, how we view success and how we're going to go about reaching these very aspirational goals for helping to improve standard of care for patients with cancer and then a lot of details and really getting in the weeds on a variety of different molecules that we're really excited about.
Unknown Executive: So look forward to seeing you there. Thanks, operator.
Unknown Executive: Thank you.
Stephen Willey: One moment for our next question.
Jeffrey Hung: Our next question comes from the line of Jeff Hung from Morgan Stanley. Thanks for taking my question. Can you talk about what differentiates XL495 from other PKM at one, inhibitors in development? And what gives you confidence that it can be best in class? You know, the greater selectivity, potency, lower risk of drug-drug interactions or something else? Appreciate it, and color you can provide. Thanks.
Dana: Sure. Thanks. Thanks for the question, Jeff. This is Dana. You know, so as I mentioned, XL495, we believe to be best in class. We don't say that lightly. We have a lot of data to back that up.
Dana: All I really want to say right now is to stay tuned for R&D Day, which is where we will be presenting a lot more data on this compound. But we did look at the competition and pursued a very solid rationale toward developing something that was best in class, not just a second follow-on compound. Thank you, Dana. Thank you. One moment.
Unknown Executive: Yes, one moment for our next question. Our next question comes from the line of excerpt from BMO capital markets. Great. Thanks for taking the question. So thank you for laying out sort of the I&D plans for XL495.
Unknown Executive: But just wondered if you could comment at all on sort of, you know, the phase one assets that you have in development and maybe for 2024, where we could see potential proof of concept in the clinic with, you know, assets like CBX12, the ADU 1805 compound and some of the other assets that you have. And phase one early clinical trial, I guess, is sort of where we could see potential proof of concept there.
Unknown Executive: Thank you. Hi, it's thanks to Samuel. I'll take that so we do have some other assets that are partners that are in phase one and we are actively always looking at the data and will make database decisions on how those progress and move forward. But those are good partnerships with our XBO2 that is advancing into its expansion cohorts. I would say, you know, we're in the process of understanding really proof of development in the way I differentiate proof of concept from proof of development is proof of concept.
Unknown Executive: We have a couple of responses and it's interesting, or you hit a part of the dynamic marker. It looks like the drug is doing something to the tissue in the in the human, but you don't yet know how to move that into a pivotal study. These expansion cohorts for XBO2 will actually are designed to actually inform us if we see a certain amount of activity. How would we move into pivotal studies and so those expansion cohorts are enrolling when they mature and when we have that data is, you know, it's dependent on how long it takes for the responses and and the durability of the responses. So, you know, we could have some things in 2024.
Unknown Executive: And then for Excel, the USP one inhibitor, right? That's just getting started. And as we transfer that in and we go through dose installation, I think we'll have a better understanding of what we need to see in terms of proof of development there, I think we already have a good head start understanding the patient population that it's most likely to respond to this sort of an agent and harnessing that knowledge in terms of our eligibility criteria. We'll help us understand how we might quickly move into full development with that asset and I think I'm not up there. All right, Amy, thank you.
Unknown Executive: Operator, we'll take the next question.
Unknown Executive: Thank you. One moment for our next question.
Christopher Lail: Our next question comes in the line of Chris Shibutani from Goldman Sachs. Hi, this is Stephen on for Chris. Thank you for taking our questions. Two from us on cabinet, the data that was presented at Ezmo showed quite a clear PFAS benefit, though the OS curves didn't separate as much. So I guess in that light, how confident are you that regulators will view that data package as an approval data set. And then on Excel 309, recently in license, can you speak to what gives you confidence that that could be a best in class asset among competitive USP1 hibbers.
Christopher Lail: Thank you. Okay, good. So Amy, want to take the cabinet question and then Dana can speak between them. Yeah, thanks for the question, Stephen. It's an important question to bring up because the way the study was designed is that crossover was allowed. And the study wasn't blinded early due to the significant benefits in progression free survival that was observed. And all patients at that point in time were crossed over. So there's not really an expectation for survival, for us to observe survival.
Christopher Lail: Whether or not that passes the fifth test of the agency world is, you know, it's a discussion we'll have where pretty optimistic given that this is such a rare disease and a high unmet need in late lines of setting where patients really have nothing else available to them. So we're optimistic, but you know, again, we have yet to have that initial discussion. Great. Thanks for the questions, Stephen. Regarding 309. So even though that's an in license compound, we actually did quite a bit of experimental work ourselves in our own labs with that molecule, we have quite a data set that supports our statement that we believe it to be best in class.
Christopher Lail: And so similar to what I said about XO4 and fiber planning to give a lot more detail at R&D data, so just say station for the update there, we'll see a lot more. You get a lot more information on the molecule. Thank you. One moment for our next question.
Joe: Our next question comes in the line of Joe Katzaro from Piper Sandler. Hi, everybody. Thanks for taking my question. Maybe just a quick one for me. So Amy, I know you have some ADC experience and some prior roles. So just wondering how you think about the next gen TOP1 tissue factor ADC that you guys have in the pipeline relative to XBO2. And maybe more generally how you think about course that in tubulin-based payloads versus TOP2 summaries based payloads.
Joe: And maybe how you develop these two programs sequentially. Thanks. Hi, Joe. Thanks very much for the question. Thanks for the welcome. Yep. I definitely have some experience in the ADC. So with regard to the TOP1 payload, I think it's actually an opportunity to take a molecule which into tumors that both express tissue factor. And our sensitive to topoisomerase inhibitions are not all tumors that express tissue factor. Our sensitive to anti tubulin-like aura statin.
Joe: So adding a different payload actually allows us to potentially cast a wider net with regard to some of the tumors that we might pursue. And of course, we would offer a differentiated toxicity profile when it comes to the aura statin versus MMA. There are certain toxicities that are similar. For example, I talked but there are other toxicities that aren't as similar between our payload and what you might expect from tip deck.
Joe: So neuropathy and bleeding is not something that we would expect to see with with ours. So the payload is different for our XBOO2 than what is with tip deck. We're already starting to have a differentiated toxicity profile. We're excited about the data that tip deck has shown and that offers us an opportunity to think about how we might bring XBOO2 forward into that space leveraging our differentiated toxicity profile. So I hope that answered your question. Further to me. Thank you.
Stephen Willey: One moment for our next question. Our next question comes from the line of Stephen Willey from Steve Full. Yeah, good afternoon. Thanks for taking my questions and just a couple quick clinical ones for me. So on Stellar 305, I'm just kind of curious. I know Merck announced the leap 10 trial didn't hit at 10 points. I guess a couple of months ago and just curious how you think about Zanz a differentiation relative to Linda and it within the setting of pet and neck.
Stephen Willey: And then maybe just a quick follow up to Joe's question. I know for June 101, you're not looking at cervical is part of any of the combination expansion cohorts. And I guess just kind of given some of the concern around combining hip-dack with Bev and the overlapping leading risk is kind of curious why that's not on your radar screen right now. Thanks. Okay, let's what's handled maybe maybe held with second question first just to clear up that discussion.
Stephen Willey: Yeah, that up cervical cancer is in our list of expanded cohorts for June 101. We are absolutely investing in it. And then with regard to Stellar 305, what gives us confidence, even though Penn Lenn didn't quite hit the mark is the data that was generated with Cabo come in the study of 33 patients where we had a 54% response rate and a PFS of 14.6 months. I think that that's much more favorably to what Len Pem showed in their phase two, which was an ORR 36% and a PFS of 8.2 months.
Stephen Willey: So we're different. So since that was Cabo Pem, this is what we're bringing forward is Zanz a Pem, which is what we believe to be a best in class and better than what we could have observed with Cabo and already Cabo Pem in cross trial comparisons looks to be better than Pem less. Thank you. One moment for our next question.
Unknown Executive: Our next question comes from the line of Christopher Lail from leering partners. Hey guys, thanks for the questions. So you mentioned that during the R&D day, it's going to be folks a lot on the science, just wondering if there's any color you can give us in terms of, you know, when we can expect to see data for some of these pipeline assets, like the district back charting ADC, the CDK 7, the USP one that you recently in license anything on that.
Unknown Executive: And then in terms of just a quick second question. And in terms of business development, are you guys looking to, are you guys looking at assets that are earlier in the clinical stage, or would you guys consider something later on in the clinical stage as well. Yeah, thanks for the, thanks for the questions, Chris. It's my going to both questions. Starting with the question. First of all, we're very interested looking for molecules that are clinical stage assets, early stage, mid stage, late stage that have the data that help us understand the potential for both clinical and clinical.
Unknown Executive: And then we're going to have a little bit more commercial differentiation, right. So that can be early and that can be late. Again, we have to be, we have to have the right level of conviction that what we're looking at and potentially either partnering or acquiring can really move the middle of patients because, again, the top of the lens, that's the only way we're going to be able to build value in this very, very competitive.
Unknown Executive: In terms of energy day and timelines, getting in the weeds there probably isn't advisable right now. I don't know we handle all that in December. I think it'll be a great great morning and looking forward to having everybody there. So again, we can frame the science with the strategy with the details to help everybody see where we're going and how we're going to be able to get these really large aspirational goals to help patients cancer. Thank you, Mike. Thank you.
Unknown Executive: At this time, there are no further questions.
Susan Hubbard: And so I will turn the call over to today's host, Susan Hubbard. Ms. Hubbard? Yeah, thank you. And thanks everybody for joining us today. Certainly, if you have any follow up questions, don't hesitate to reach out to the air for us. We'll get back to you right away.
Susan Hubbard: This concludes today's conference call. Thanks for participating. You may now disconnect. [inaudible] Thank you.
Susan Hubbard: Thanks for joining us today, Susan Hubbard.