Q1 2022 Puma Biotechnology Inc Earnings Call
Good afternoon. My name is Karen and I will be your conference call. Operator today at this time all participants are in a listen only mode.
After the Speakers' formal remarks, there will be a question and answer session.
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If you should require operator assistance during the conference you May Press Star Zero as a reminder, this call is being recorded I would now like to turn the conference call over to Marianne O Hannesson senior director of IR for Puma Biotechnology, you may begin your conference.
Thank you Sharon good afternoon, and welcome to Puma's conference call to discuss our financial results for the first quarter of 2022, joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the board of Sumer, Biotechnology, Maximo, and your guess Chief Financial Officer, and Jeff Ludwig.
<unk> Chief commercial officer.
After market close today Puma issued a news release detailing first quarter 2020 to financial results that news.
He was released the slide suggests we'll refer to and a webcast of this call are accessible by the homepage and investor sections of our website at Puma Biotechnology Dot com.
Webcast and presentation slides will be archived on our website and available for replay for the next 90 days.
Today's conference call will include statements about the company's future expectations plans and prospects that constitute forward looking statements for purposes of federal Securities laws.
Such statements are subjects are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward looking statements.
For a full discussion of these risks and uncertainties. Please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year ended December 31, 2021.
You are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this live conference call May five 2020, Q. The company undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call, except as required by law.
Yeah.
During today's call. We may also refer to certain non-GAAP financial measures that involve adjustments to work out figures.
We believe these non-GAAP metrics may be useful to investors as a supplement to but not as substitute for our GAAP financial measures.
Refer to our first quarter 2022 news release for a reconciliation of our GAAP to non-GAAP results I will now turn the call over to Alan.
Yes.
Thank you Mary Anne and thank you all for joining our call today.
Today Puma reported total revenues for the first quarter.
Of 2020 to $45 7 million.
Total revenue includes product revenue net which consists entirely of narrowing sales as well as license fees and royalties for myself licensees.
Revenue net was $40 7 million in the first quarter of 2022, which represents a decline as expected from the $51.1 million in revenue and product revenue reported in the fourth quarter of 2021, and $45 8 million in product revenue reported in Q1 2021.
Yeah.
Product revenue for the first quarter of 2022 included approximately $4 3 million of inventory draw down at our specialty pharmacies and specialty distributors royalty revenue was $5 million in the first quarter of 2022, an increase from $2 9 million in Q4, 2021, and $2 4 million in Q1 two.
<unk> thousand 21, we recorded no license revenue in the latest quarter.
We reported 2000 and 680 bottles of new Airlink sold in the first quarter of 2022, a decline from the 3454 bottle sold in Q4 of 2021 as we noted on last quarter's call bottle sold in the fourth quarter included an approximate an estimated 345 bottle.
<unk>, representing inventory stocking at our specialty pharmacies and specialty distributors, we estimate the inventory stocking decreased by approximately 282 bottles in Q1 of 2022.
In Q1, 2022, new prescriptions were up approximately 17% compared to Q4, while total prescriptions were down approximately one 7% Jeff will provide further details in his comments and slides.
I will not provide a clinical review of the quarter and then Jeff Ludwig will add additional color on the earliest commercial activities Maximo <unk> will follow with highlights of the key components of our financial statements for the first quarter of 2022.
As we have mentioned in our prior calls.
It has an ongoing basket trial of Niraparib and.
And it hurts your mutated cancers referred to as the summit trial.
In the fourth quarter of 2021 met with the FDA to discuss the regulatory path for in Iraq in patients with hormone receptor positive her two negative breast cancer, who have of her tumor mutation.
Investors don't remember that based on the meeting with the FDA in the fourth quarter of 2019.
This arm of the summit trial was modified such that patients were randomized to receive either the strength alone <unk> plus trastuzumab or the combination of niraparib plus for that strength plus trastuzumab.
Initial Simon two stage design each of the three arms enroll seven patients during stage one.
No patient in a given arm responded that arm was closed to further enrollment in the first stage one or more patients responded the arm with an expanded up to 18 patients if less than four patients in the expanded arm responded that arm was closed to further enrollment if.
More than four patients responded the arm was expanded to 30 patients.
As was previously disclosed to investors analysts presented at the San Antonio breast cancer Symposium in 2021.
But the first seven patients who were treated in the photo strength alone arm of the trial no patients achieved a response and the seven patients who were treated with <unk> plus trastuzumab arm of the trial no patients achieved a response.
First seven patients who were treated and in retina, plus <unk> plus trastuzumab arm of the trial, one or more responses were seen and therefore the criteria is met to expand to stage two of assignment two stage design.
That arm of the trial was expanded to further enrollment and an additional 18 patients had been enrolled with the combination of Niraparib plus <unk> plus trastuzumab.
Yeah.
Enrollment to that this arm has been stopped while we analyze the additional data.
At the meeting with the FDA in the fourth quarter of 2021, the data from the seven patients randomized to each of the three arms with shared with the F. D. A.
I'm also told the FDA that they had an additional 18 patients who had been treated with the combination of Niraparib plus sylvestris, plus trastuzumab and the data from these 18 patients could be shared with the FDA in 2022, Puma plans to submit to FDA in the second half of 2022 and schedule a meeting to discuss the regulatory path for <unk>.
In this indication.
<unk> anticipates that the SBA will either allow the company to file for accelerated approval based on the existing single arm data.
They require additional data or may require a separate randomized trial for this indication.
A randomized trial is required the company will make a decision as to whether or not to proceed based on the time and cost of the trial versus the potential market opportunity.
Additional data from this cohort will be presented at the American Society of clinical oncology annual meeting in June of 2022 pivotal also plans to present data at the Ash annual meeting from the cohort of patients in the summit with her two mutated biliary tract cancer, who were treated with in a rightness promo will continue to update investors on the status of this.
As it progresses.
As investors are also aware in November 2020, we announced interim data from another cohort of the summit trial more specifically the cohort of patients with metastatic non small cell lung cancer with epidermal growth factor or Egfr.
Exon 18 mutations who had been previously treated with an egfr targeted tyrosine kinase inhibitor.
I wish as was shown in the data that was presented there were four responses out of 11 patients and therefore the criteria have been met to proceed to stage two of the Simon two stage design enroll 30 patients. There are currently 31 patients enrolled in this arm of the trial and we anticipate that we will have additional data from this cohort to report in the second half of 2022.
What should we received this data we plan to meet with the FDA to discuss the regulatory path for this indication.
<unk> anticipates that the FDA will either allow the company file for accelerated approval based on a single arm data or may require additional data or a separate randomized trial for this indication.
Randomized trial is required the company will make a decision whether or not to proceed based on the time and cost of the trial versus the potential market opportunity enrollment to this arm of the trial has been halted while we analyze the current data and wait for regulatory guidance.
As mentioned on the last earnings call to them. It is also evaluating several drugs to potentially in license that would allow the company to diversify itself and leverage moonves existing R&D regulatory and commercial infrastructure to them.
We'll continue to update investors on the status of this as it progresses I will now turn the call over to Jeff Ludwig who must chief commercial officer for a review of our commercial performance during the quarter.
Thanks, Alan I appreciate it and thanks to everyone for joining our first quarter earnings call.
Before I move into the commercial review just a reminder, that I will be making forward looking statements.
So let me start by reinforcing our commitment and our passion about helping patients in their battle with breast cancer. We believe that <unk> can play a key role in both early stage disease to prevent reoccurrence after adjuvant trastuzumab based therapy as well as in metastatic disease.
<unk>, we remain focused on three areas number one leveraging our communicating the evolving positive clinical data in their legs.
Number two engaging and educating patients about the risks and benefits of near links and three increasing our impact through field force execution and evolution.
Now I'm happy to see progress being made on all three fronts. We saw steady increases in our call activity in Q1 as access increases in parts of the country and our sales team became more comfortable in their new geographies. Following our Q4 reorganization.
Over 60% of our calls made in Q1 were alive versus virtual and we saw a steady increase in live calls versus virtual calls throughout the quarter.
Now the ebb and flow of Covid has been hard to predict but we are hopeful this trend will continue.
In addition, we increased our outreach to patients in various advocacy groups adjusted our personal and non personal promotional mix and stayed focused on communicating the clinical benefits of neuro links including the previously announced updates to the NCC in clinical practice guidelines for the treatment of breast cancer.
This market remains underpenetrated and we're committed to doing more to help support women battling breast cancer.
With that high level update let me transition to some of the U S. Commercial slides once I finish my remarks, I will turn the call over to Maximo for a more detailed review of our financial results.
On slide three you see that our distribution model has not changed.
We have two channels that provide neuro links to patients we refer to these as our specialty pharmacy channel and our specialty distributor channel or in office dispensing channel.
The majority of our business continues to flow through the specialty pharmacy channel in Q1, approximately 81% of our business went through this channel with the remaining 19% of the business flowing through the specialty distributor channel.
This is slightly different than the 76% specialty pharmacy, and 24% specialty distributor mix that we reported in our Q4 earnings call. This change is.
It's driven by a larger percent drawdown in the SD channel as well as some SD demand softness that occurred in Q1.
Slide four shows U S quarterly net sales of <unk> since FDA approval.
As Alan noted our net product sales were $40 $7 million in our first quarter of 2022. This.
This is a decrease from the $51 million, we reported in Q4 of 2021.
This change is being driven by an estimated $5 million build that occurred in Q4 of 'twenty, one and a subsequent inventory drawdown of approximately $4 3 million that occurred in Q1 of 2022.
This pattern of inventory build in the fourth quarter, followed by a subsequent inventory reduction in Q1 is common and has been seen in prior years as shown on the slides.
Now slide five shows the bottle of narrowing sold by quarter since launch.
Please note. This slide shows ex factory bottle sold so it represents sales into our into our specialty pharmacy and specialty distribution channel and not end user demand.
We sold 2680 bottles of <unk> and Q1 of 2022 which is a decrease of 774 bottles from our Q4 2021 bottle sales of 3000 and 450 for the.
The majority of this decrease was a direct result of the inventory build that occurred in Q4 and the subsequent inventory drawdown in Q1 2022.
Now, let me provide some additional insight into the business.
New prescriptions are new patient starts are a very important leading indicator for our business. These new patient starts turning to refills, which will influence subsequent quarters in terms of total bottle sold.
As highlighted in previous earnings calls, we tend to see a decline in new patient starts in the fourth quarter with a subsequent increase in the first quarter of the following year due to some patients deciding to delay starting on <unk> until after the Q4 holidays.
This pattern did play out well.
We previously highlighted that new patient starts declined by about 8% in Q4 of last year, which was a smaller decline than we had seen in the last several years, but nonetheless still a decline.
This decline impacted our total bottle sales in Q1 of 2022.
As importantly, we did see new patient starts grow by about 17% in Q1, which should benefit us in subsequent quarters as well.
In regard to free drug we continue to see an increase in a number of patients qualifying for free drug through our patient assistance program, which is being driven largely by an increase in Medicare patients who cannot cover the cost of their co pay and are unable to obtain financial assistance due to the limited availability of co pay support from the foundations.
As previously reported we were excited to have dose escalation added to our label in late June of last year for both our extended adjuvant indication as well as our metastatic indication.
In addition, we were very pleased that N C. C had updated their 2022 clinical practice guidelines for breast cancer to include dose escalation in early stage breast cancer.
As you can see on slide six we did see an increase in the adoption of dose escalation in the first quarter were almost 62% of patients were started on neuro links at a lower dose.
Dose escalation can clearly benefit patients by significantly reducing the amount of grade three diarrhea, and reducing overall discontinuation. We continue to highlight these benefits and are committed to seeing this adoption continued to grow.
Now on slide seven you see the highlights of our strategic collaborations that we have formed across the globe with the goal of making <unk> available to more patients around the world.
We are pleased with our global partners and the progress being made.
In Q1 of 2022 we saw regulatory approval in Mexico for the extended adjuvant indication and neuro links was officially launched in both Ireland and South Korea.
I highlighted in our Q4 earnings call that <unk> was added to China's national reimbursement drug list or <unk> for 2022.
And our <unk> approval is an important milestone the early feedback has been positive and we're excited to see access increase in China for women battling early stage breast cancer.
I'll just to wrap up.
<unk> was founded on a commitment to making a difference in the lives of patients and their families battling breast cancer.
The commercial team for their continued passion and commitment to making such a difference we know more has to be done and we're not going to stop until we achieved that goal.
I will now turn the call over to Maximo for a review of our financial results Maximo.
Thanks, Jeff.
I will begin with a brief summary of our financial results for the first quarter of 2022.
Please note that I will make comparisons to Q4 2021, which we believe is a better indication of our progress as a commercial company.
Year comparisons.
For more information I recommend that you refer to our Q1 2022 thank you.
Which will be filed today and includes our consolidated financial statements.
For the first quarter of 2022, we reported a net loss based on GAAP of $3 4 million.
Alright cents per basic and diluted share.
This compares to a Q4 2021 net income of $4 2 million or 10 cents per share.
The non-GAAP basis would you say adjusted to remove the impact of stock based compensation expense.
We reported a net loss of <unk> 3 million Watson per basic and diluted share for the first quarter of 2022.
Gross revenue from Nellix sales was $51 5 million in Q1 2022.
Versus $64 5 million in Q4 'twenty to 'twenty one.
As Alan mentioned it net product revenue from Airlink sales was $40 7 million compared to the 51 million we reported in the fourth quarter of 2021.
We believe our Q1 net sales included approximately $4 3 million.
Inventory drawdown from our distributors.
Yeah.
Royalty revenue totaled <unk> 5 million in the first quarter of 2022 an.
An increase from $2 9 million in Q4 2021.
Our gross to net adjustment in Q1, 2022 was 21%.
Lots from the gross to net adjustment in Q4, 2021.
Increases to coverage gap and co pay charges were offset by decreases in Medicaid Medicaid expenses to keep our quarter over quarter gross to net flat.
Yeah.
Cost of sales for Q1, 2022 was $10 $8 million, including $2 million for the amortization of intangible assets related to our Neurotogenic license.
Cost of sales for Q4, 2021 was $11 9 million.
Going forward, we will continue to recognize amortization of milestones with the lessons or worried about $2 million per quarter as cost of sales.
For fiscal year, 2022 Puma reiterate its previous guidance of net product revenue will be in the range of $180 million to $190 million.
You also anticipate that our gross to net adjustments for the full year 2022 will be between 21% and 22%.
Slightly better than our prior guidance.
Furthermore for fiscal year 2022 we continue to anticipate receiving royalties from our partners around the world in the range of 27% to $34 million.
And we don't expect license revenue in 2022.
We recognize there continues to be a great deal of uncertainty regarding the impact of COVID-19.
And this may continue to negatively impact our sales royalties and license revenue.
We anticipate that for Q2 2022, <unk> net sales will be in the range of $44 million to $47 million.
We also anticipate Q2 royalty revenue will be in the range of $7 million to $9 million.
We estimate that the gross to net adjustment in Q2, 2022 will be approximately 20% to 21%.
Puma anticipates that net income in Q2 of.
2022 will be slightly positive.
SG&A expenses were $20 4 million in the first quarter of 2022.
Compared to $22 5 million in Q4 'twenty to 'twenty one.
G&A expenses included noncash charges for stock based compensation of $2 2 million for the first quarter of 2022.
Compared to $2 4 million for Q4 2021.
Research and development expenses were $15 2 million in the first quarter of 2022.
<unk> to $14 2 million for Q4, 2021.
R&D expenses included noncash charges for stock based compensation of <unk> 9 million in the first quarter compared to $1 8 million for Q4, 2021.
The first quarter of 2022.
Reported cash burn of $70 million compared to cash burn of $5 4 million in Q.
Q4, 2021.
In Q1, 2022 we made a payment of $27 1 million related to our class action lawsuit and executed a private placement for 10 years.
Yes.
As a result of cost containment actions across the company implemented in the fourth quarter of 2021.
<unk> continues to expect lower operating expenses in 2022 compared to 2021.
More specifically, we anticipate SG&A expenses to be down approximately 15% to 20% and R&D expenses to be down 10% to 15% year over year.
At March 31, 2021, we had $73 9 million in cash cash equivalents and marketable securities.
Accounts receivables balance was $27 million.
Our accounts receivable terms range between 10, and 68 days, while our days sales outstanding is at about 47 days.
We estimate that as of March 31, 2022, our distribution that will maintain approximately four weeks of inventory.
Overall, we continue to deploy our financial resources to focus on the advancement of neuropathy in two ongoing clinical trials and then commercialization of Nellix.
Thanks Maximo.
During 2020 and in 2021, the COVID-19 pandemic presented significant commercial challenges to Puma and presented significant barriers to commercial access for <unk> commercial team. We are hopeful that with Covid cases, declining and vaccination and booster rates, increasing these barriers were reduced in the future, which should improve the ability of <unk>.
Our commercial team to access and interact with health care providers to increase their awareness of the neuro links data. We also recognize the uncertainty as to when access to health care providers will improve and we are remaining conservative in our outlooks for improvements in access for this year to.
<unk> senior management in cooperation with the board of Directors continues to remain focused on improving nearly <unk> sales in 2022 and beyond in the fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operating cash flows.
Company remains committed to protecting these operational cash flows and will continue to reduce expenses if needed to achieve this.
We look forward to updating investors on this in the future.
There continues to remain a significant unmet need for patients battling breast cancer lung cancer and other solid tumors, we had kumar our committed and passionate about finding effective ways and helping these patients during their journey and we will continue to strive to achieve that goal.
This concludes today's presentation, we will now turn the floor back to the operator for Q&A operator.
Thank you we will now begin the question and answer session.
You wish to ask a question. Please press star one on your telephone keypad at this time, a confirmation tone will indicate your line is in the question queue.
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Again, if you do have a question or comment you May press star one on your telephone keypad at this time we.
We will take our first question from Ed White with H C. Wainwright. Please go ahead.
Good afternoon, and thanks for taking my question.
Just a couple of questions on it.
On the sales force you had mentioned that 60% of your calls are wise.
Can you give us some background about where that what what the change has been over the last quarter and perhaps did you see a change from January to March.
Yeah sure happy to do that the short answer to both is yes, we saw it.
A larger percent of verge of live calls in Q1 versus Q4, So we saw improvement there.
January was slightly better than December , but February and March we saw fairly significant and steady improvement on live versus virtual so we've seen that trend continue actually throughout the quarter.
And do you have any data showing that <unk>.
Live is better than <unk>.
Virtual as far as Oh, the account penetration is concerned.
So I've seen a couple of things.
Feedback from the field certainly is that the live interactions are deemed to be more valuable. We've also seen market research from <unk>.
ZFS that says the sort of fatigue virtual calls across the industry has started to weigh in and so we are qualitatively and quantitatively believe that live calls are better it's giving us more time in front of customers as well.
If I can add to that I think the other aspect with live calls is that you know oftentimes the wrap is going into a practice thats got multiple physicians in multiple hep's, there as well as you know nurses and other things when they are alive, they get the opportunity to interact with lots of people, whereas on a virtual call. It's just going to be one on one with the health care provider.
Or something like that.
In a life situation, we kind of refer to it as the total office call being able to speak to as many people in the office as possible you, obviously have more of an opportunity for that.
Okay. Thanks, Alan and last question just you had mentioned that the distribution network is sitting at an on about four weeks of inventory currently.
Do you expect that to remain stable or should we see a change perhaps a down to three or up to five at some point.
And we do see some fluctuations in our inventory levels, but that that level is about normal we don't expect it to be significantly different than that as we mentioned in the call. We saw a fairly significant inventory build in the in the fourth quarter. We subsequently saw that decline largely early on in.
In the first quarter and it's now for the most part stabilized a week over week. So we think that's a fairly good inventory estimate at this time, yes add to take put a few more numbers behind it in the fourth quarter. We said that the inventory build was about 345 bottles. We saw that worked down by 282 bottles in Q1. So there is still a little bit there.
And they are not that huge looks like around 50, or 60 bottle or so my anticipation would be that that might get slowly worked down over Q2 and Q3.
And then again in Q4, we would expect to see an inventory build like we see every year, so that would be kind of be a what I would expect for the future quarters.
Thanks, and if I could.
And one last question.
Can you make any comments on duration that the patients are staying on drug you know how is it looking for the number of bottles per patient.
Okay.
And we do track.
Duration of therapy, and what you see with neuro lengths is that first refill is really important if we can get patients through that first where you feel that first that second month on drug into the second month and drug discontinuation rates drop off which is what we're trying to achieve here.
We certainly believe that with the increase of dose escalation, we will see more second fills or the first refill.
The bulk of our patients on dose escalation as you look at our slide really has occurred in the last 369 months, we see that bolus above 50%. We are tracking those cohorts I don't have any updated data to quantify that yet, but what I can tell you is in dealing with customers the feedback from customers on dose escalation.
<unk> is that it's much easier for patients much easier for the practice much easier for physicians. We've also seen that physicians that adopt dose escalation are more likely to treat additional patients with no links as well hopefully that helps them.
That does thanks, so much for taking my questions.
You're welcome.
We will take our next question from Yigal <unk> with Citi. Please go ahead.
I think this is a ausopen bark on for Yigal. Thanks for taking my question.
I apologize if I missed this in your prepared remarks, I was hopping between calls but.
Can you help level set for your upcoming <unk> data for the summit cohorts, maybe any color on how much.
How many patients level of detail level of follow up that you'll present for both the <unk> mutant breast in biliary tract cancer.
Presentations.
Yeah.
So in terms of the her two mutant breast I believe it would be the.
The additional 18 patients that have been enrolled since we last.
Since we last updated.
And then on the <unk>.
Billy Aerie I apologize I don't remember the number off the top of my head.
But it would be the four cohorts.
It'll be presented.
Okay in terms of the data I would expect to see the standard response rate PFS and things like that.
Okay.
And then maybe I'll sneak in one more follow up.
I know you've been.
I'm waiting FDA discussions are related to the potential for accelerated approval and in Virginia in breast and Egfr exon 18 long.
Do you have any updated thoughts on how.
How have you been weighing on ROI in terms of.
Maybe the need to run additional studies. So I'm just curious what your latest thoughts are.
Well, Yeah, I think we have all seen that the FDA seems to be a little more reticence to allow accelerated approvals on single arm data.
They just had the recent panel the panel discussion on that whole topic, and so you know I.
I think there is certainly risk to that.
Given the way the FDA appears to be communicating things, we obviously won't know until we speak with them and until we analyze all the data as well. So we really don't know now in terms of kind of the you know.
Risk benefit and ROI of doing that.
Going to start a randomized trial in 2003, assuming the full three years for that trial to go forward you know you're talking about probably 2026 getting that data for an approval in 2027, and our composition of matter patent expires in 2030, so that that would be the calculations, we would be using it.
To determine the ROI on that.
Okay. Thanks for all the color.
We'll take our next question from Vivien <unk> with Cowen <unk> company the floor is yours.
Good afternoon. This is David on for Mark. Thanks for taking our question I just have two one is on that on the commercial side, but do you have a sense for the sort of breakdown in terms of per distribution between the commercial and maybe government or a Medicare based plan.
And then just another question on just the revenue breakdown based on your guidance it looks like for the first half of the year. We're looking at like about 87 million at the upper end.
And then about an 18% increase in H two.
Do you have any color on kind of the assumptions, you're making for that for that increase would be helpful. Thank you.
Okay.
Okay.
Hey, Thanks for the questions I'll take the first question you had on payer mix and obviously, our payer mix does fluctuate, but let me give you a general color we have about 65% of our business is commercial payers I would say about 23% or so 24% is government Medicare Medicaid.
Uh huh.
And then we do have certainly.
About 10% or so that is either other uninsured that that does not include any acknowledgment of insurance coverage.
And then on your second question, which is the.
Revenue breakdown.
Our assumption is that you will see.
Slight growth.
In terms of the Q2 to Q3 with the bulk of that growth being Q3 to Q4.
Okay. That's helpful. Thank you.
And then as we mentioned we're expecting them to be.
Slightly net income positive in Q2.
Yeah.
Yeah.
And for our next question will move to Geoff Meacham with Bank of America. Please proceed.
Hi, This is Alex on for Geoff Meacham. Thank you for taking our question could you talk about your expectations from the cohort four b and foresee the phase two trial of the combination of <unk> plus <unk> in patients with her two positive breast cancer.
And brain metastases who've been previously treated with Quechua. Thank you so much.
Okay.
Yeah. So this is on TV CRC 'twenty two.
Which is our trial of Niraparib in patients with brain Mets. So as you correctly pointed out there are two cohorts one of them is in Radnet plus cat silo in patients who are ketsana naive.
They're out there plus cat siloed in patients who've already seen cat silo. So this is going to be very interesting data because it's going to be very applicable applicable to the current treatment paradigm for her two positive.
Breast cancer with brain Mets, because you are certainly seeing patients who have previously seen cat silo either in the adjuvant setting.
Or in the metastatic setting and then have brain Mets and then you're also seeing patients where they did not have kept silo, either adjuvant or metastatic and perhaps get your Kaiser.
Their first treatment and therefore their cats island naive so our expectation would be that we would see.
I don't remember the number of patients off top my head I am guessing its somewhere around 2025 ish.
Where we would see.
Response rates and PFS in both of those cohorts I.
I do believe we will see patients who have previously been treated with two guys as well. So I think it's going to be very real world are applicable.
And remember that <unk> is in the antiques and guidelines for brain Mets. So.
If indeed the data is positive we would have the opportunity to potentially submit it to the CCN for inclusion.
It should allow physicians to be able to utilize it if they so wished.
Thank you.
And for our next question will turn the floor over to Gena Wang with Barclays. You May proceed.
Hi, This is sheldon on for Gena, Thanks for taking all my questions.
Maybe one on the excellent 18 mutation non small cell lung cancer cohort that's the expected in second half this year.
So you mentioned that you have 31 patients enrolled.
Could you comment on how many of those patients have passed a ti failure. So I suppose that will be the.
Ultimate cohorts that will support the FDA approval right.
Yeah, correct. So from a registrational perspective, it would be that we'd be focusing on the patients who have already seen an egfr take care. So the exon 18 mutations where they are.
Ive two in Egfr T K I tend to be responsive to a first line teekay and that can be the first generation drugs. So.
Fitness, but are a lot of the work.
Or can be the second generation drugs like a fat nib and awesome <unk>.
My understanding is I think those 30 patients. The large majority of them have already seen that teekay I because that was where we had focused the development of the drug. So I would envision that the large majority of them have indeed failed in Egfr T. Kat.
Got it thanks.
This concludes our question and answer session I would now like to turn the conference back to Mary Anne for closing remarks.
Okay.
Thank you for joining us today.
Mind, you that this call may be accessed via replay of the webcast and Puma biotechnology Dot com beginning later today.
Have a good evening.
Ladies and gentlemen, thank you for participating in today's conference call. This concludes our program everyone have a great day and you may now disconnect.
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