Q4 2022 Puma Biotechnology Inc Earnings Call
Good afternoon, My name is Diego and I will be your conference call operator today.
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I would now like to turn the conference call over to Maryann or Hannesson senior director of IR for Puma Biotechnology, you may begin your conference.
Thank you Diego.
And welcome to <unk> conference call to discuss our financial results for the fourth quarter and full year 2022.
Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the board of Puma extra ammonia gas Chief Financial Officer, and Jeff Ludwig Chief Commercial Officer.
After market close today Puma issued a news release detailing fourth quarter 2022 financial results.
That news release, the slides that Jeff will refer to and a webcast of this call are accessible via the home page and investors sections of our website at Puma Biotechnology Dot com.
Yes, the 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 subject to risks and uncertainties and actual events or results may differ from those expressed in these forward looking statements.
For a 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.
Remember 31 2022.
You are cautioned not to place undue reliance on these forward looking statements.
We speak only as of the date of this live conference call March 2023.
The company undertakes no obligation to revise or update any forward looking statements to reflect these answers circumstances. After the date of this conference call, except as required by law.
During today's call. We may also refer to certain non-GAAP financial measures.
Bob adjustments to our GAAP figures, we believe these non-GAAP metrics may be useful to investors.
A supplement to but not as substitute for our GAAP financial measures.
Please refer to our fourth quarter 2022 news release for a reconciliation of GAAP to non-GAAP results I will now turn the call over to Alan.
Yeah.
Thank you Marianne.
And thank you all for joining our call today.
Today Puma reported total revenue for the fourth quarter of 2022 of.
$65 7 million.
Total revenue includes product revenue net which consists entirely of near link sales as well as license fees and royalties from our sub licensees.
Product revenues net was $53 7 million in the fourth quarter of 2022 compared to $54 3 million reported in Q3 22.
And 51.0.
Million reported in Q4 of 2021.
Product revenue for the fourth quarter of 2022 included approximately $2 6 million of inventory build at our specialty pharmacies and specialty distributors.
Royalty revenue was $12 million in the fourth quarter of 2022, an increase from $2 8 million in Q3 of 2022.
Increased from $2 9 million in Q4 of 2021, we reported no license revenue in 2022.
We reported 3323 bottles of nearly sold in the fourth quarter of 2022 compared to 3197 bottle sold in Q3 of 2022, we estimate that Q4 inventory build amounted to approximately 164 bottles.
In Q4, 2022, new prescriptions were down approximately 16% compared to Q3 and total prescriptions were flat compared to Q3.
Jeff will provide further details in his comments and slides.
I will now provide a clinical review of the quarter and then Jeff Ludwig will address additional color on the earliest commercial activities Maximo <unk> will then follow with highlights of the key components of our financial statements for the fourth quarter of 2022.
As investors are aware, probably had an ongoing basket trial of near right now referred to as the summit trial, which was testing it in patients with metastatic <unk> negative hormone receptor positive breast cancer that hasn't hurt your mutation.
And in patients with metastatic non small cell lung cancer that has an exon 18 mutations.
As we mentioned to investors in the past, we believe that it was unlikely that F. D. Eight would grant accelerated approval for <unk> based on the summit data and with debt and instead require us to either one do a head to head trial against standard of care in these indications or two.
Studying or at their in patient populations that do not overlap with other drugs in the rapidly changing treatment landscape.
Based on recent precedent and interactions with the FDA, which suggested that regulatory approval in these indications would require a randomized trial.
The company will not be further pursuing the development of your writing it in these indications due to the rarity of these mutations enrollment and randomized studies would be challenging and it is not clear that this would be able to be accomplished in a timeframe that would result in a positive return for Puma shareholders based on the time and cost.
Trial versus the potential market opportunity.
The summit trial is therefore being discontinued which results in a cost reduction from this trial in 2022, I'm sorry in 2023 versus the 2022.
In September two lowest pleased to announce that we in licensed the anti cancer drug al asserted from Takeda and clinical trials to date <unk> has shown single agent activity and activity in combination with other cancer drugs in the treatment of various cancers, including whole receptor positive breast cancer triple negative breast cancer.
Small cell lung cancer, and head and neck cancer.
The drug has also shown activity in previous clinical trials and peripheral T cell lymphoma, and non Hodgkin's lymphoma.
So Chad as previous clinical development program, but I'll sort of was extensive and due to this there is a large well characterized clinical safety database with over 1300 patients who were treated across 22 company sponsored trials.
As mentioned in our last earnings call, who moves in the process of transitioning the allo sort of program from Takeda to Puma.
It has now been successfully completed and the ideas currently being held by Puma.
We are currently anticipating that we will be meeting with the F. D. A in the first half of 2023 to discuss the registration path for al assertive in small cell lung cancer and will subsequently anticipate initiating clinical trials of Alistair and small cell lung cancer in the second half of 2023.
We further anticipate meeting with the F D. A in the second half of 'twenty three.
Discuss the registration pathway for al asserted in hormone receptor positive <unk> negative breast cancer and subsequently initiating clinical trials of Alistair did in hormone receptor positive <unk> negative breast cancer in the first half of 2024.
We continue to anticipate that there will be several clinical milestones for the L. A a sort of program in the coming months.
This includes the publication of the biomarker studies for the randomized trial of al surplus for industrial versus out of sort of alone in whole receptor positive her two negative breast cancer, which we anticipate in the first half of 2023.
Biomarker data from the randomized trial of <unk>, plus paclitaxel versus Paclitaxel alone and hold receptor positive her two negative breast cancer anticipated in the first half of 'twenty three.
Data from an ongoing investigator sponsored phase one two trial of.
Alastair plus plus <unk> for the treatment of patients with <unk> deficient head and neck squamous cell cancer, which as anticipated sometime in 'twenty three.
Conducting the meeting with the FDA to discuss the registration path for ulcerative in small cell lung cancer, which is expected in the first half of 2023.
And conducting the meeting with the FDA to discuss the registration path for all sorted in hormone receptor positive <unk> negative breast cancer, which is anticipated in the second half of 2023.
As mentioned on prior earnings calls and in response to Investor questions. Puma continues to evaluate several drugs to potentially in license that would allow the company to diversify itself and leverage its existing R&D regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses I will now.
I'll turn the call over to Jeff Ludwig Promos, Chief commercial officer for a review of our commercial performance during the quarter.
Hey, Thanks, Alan appreciate it and I appreciate everyone for joining our fourth quarter earnings call.
Before I move into the commercial review just a reminder, that I will be making forward looking statements.
The commercial team remains focused on and passionate about helping to support more patients battling breast cancer. Our primary emphasis is that helping her two positive patients reduce their risk of recurrence in early stage breast cancer, we would love to see more patients never become metastatic or.
Our strategy remains focused around three areas number one communicating the evolving positive clinical data for neuro links to Hep's.
Number two engaging and educating patients around the risk of recurrence as well as the risk benefit profile of neuro links and finally, three increasing our impact and share of voice through field force execution and non personal promotion.
Specifically regarding Q4 I'm very pleased that we saw Q4 year over year growth in our key metrics, including enrollments new patient starts and demand.
In regards to the share of voice. We also saw an increase in total calls comparing Q4 year over year as well as looking at Q4 versus Q3 2022.
In Q4 about 80% of our total calls were alive versus virtual which is an increase from the 77% we reported in Q3 of 2022.
In addition, our field teams increased their engagement with local and regional advocacy organizations and we have remained very thoughtful and diligent about our overall expenses with the goal of being more efficient and more effective.
I am pleased with the progress being made but know that significant opportunities still remain in front of us.
With that high level update let me transition to some of the U S. Commercial slides once I finished I will turn the call over to Maximo for a more detailed review of our financial results.
Our distribution model has not changed we have two channels that provide <unk> links to patients.
We refer to these as our specialty pharmacy channel and our specialty distributor channel or in office dispensing channel.
Most of our business continues to flow through the specialty pharmacy channel.
Q4, approximately 78% of our business went through this channel with the remaining 22% of the business flowing through the specialty distributor channel. We do see some quarterly fluctuations of this mix, but no significant changes occurred throughout the year.
Slide four shows U S quarterly net sales of neuro lengths since FDA approval as Alan noted our net product sales were $53 $7 million in the fourth quarter of 2022.
This is a $600000 decrease over Q3 of 2022 and $2 $7 million increase over Q4 of 2021.
Inventory changes, obviously have an impact on these numbers in.
In Q4, we estimate the inventory increased by approximately $2 6 million in the fourth quarter of 2022.
As a comparison, we estimated that inventory increased by approximately $5 million in Q4 of 2021.
Turning to slide five slide five shows the bottles of narrowing sold by quarter since launch.
Please remember that this slide shows ex factory bottle sold so it represents sales into our specialty pharmacy and specialty distributor channel and not end user demand.
We sold 3323 bottles of neuro links in Q4 of 2022, which is about four 4% higher than the bottle as we reported in Q3 of 2022 and about 4% lower than our bottles were reported in Q4 of 2021.
Let me again provide a little more insights around inventory changes.
We estimate the inventory increase by about 164 bottles in the fourth quarter of 2022.
As a comparison, we estimated that inventory increased by about 353 bottles in Q4 of 2021.
The commercial team is focused on execution with the goal of driving both quarter over quarter growth.
Year over year growth.
As previously mentioned, we saw Q4 year over year growth across our key performance metrics, including enrollments new patient starts and demand we.
We did not however, see quarter over quarter growth producing metrics.
As a reminder, we historically have seen enrollments and new patient starts softened in the fourth quarter as physicians and their patients choose to initiate their therapy. After the holidays in order to avoid the potential side effects of neuro links which typically occur in the first month or so.
Q4 of 2022, followed that traditional pattern of quarter over quarter decline.
Let me provide some additional specifics around this performance.
In Q4, we saw enrollments grow 1% year over year, but.
But declined 10% quarter over quarter in line with previous patterns.
The year over year growth rates and I'm quoting are comparing Q4 of 2022 for Q4 of 2021.
Moving on to new patient starts are in Rx, we saw commercial new patient starts grow 7% year over year, but declined 16% quarter over quarter <unk>.
Commercial new patient starts are an important leading indicator for us as new patient starts turning the refills, which importance subsequent quarters.
Total prescriptions, followed a somewhat similar trend with year over year being more positive in quarter over quarter.
In Q4, we saw a total rx grow 5% year over year and remained flat quarter over quarter.
For the full year, comparing 2022 to 2021 we saw enrollments grow approximately 2% and commercial new patient starts grew approximately 4%.
This is the first time since launch we have seen these positive yearly trends.
Turning to slide six we have continued to focus on the education and adoption of dose escalation.
In Q4, approximately 664% of patients who receive commercial drug started near length on a lower daily dose. This is a slight decrease from the approximately 68% we reported in Q3.
Dose escalation can clearly benefit patients by significantly reducing the amount of grade three diarrhea. The median days of grade three diarrhea, and the overall discontinuation rate we truly believe the adoptions dose escalation plays a very important role in reshaping the risk benefit profile of neuro links.
As previously reported dose escalation was added to the <unk> label in late June of 2021 for both the extended adjuvant indication as well as the metastatic indication.
In addition, N C C C. An updated their 2022 clinical practice guidelines to include dose escalation in early stage breast cancer.
I'm pleased to say that MCC and recently updated their 2023 metastatic breast cancer guidelines and included dose escalation as an option in the metastatic setting as well.
On slide seven highlights the strategic collaborations we have formed across the globe.
We are pleased with our global partners and the progress being made in.
In Q1 of 2023 neuro links received regulatory approval in the extended adjuvant setting in both Morocco and South Africa.
Also in Q1 of 2023, we are happy to announce that in Airlinks was officially launched in Mexico in the extended adjuvant setting.
Our global partners are focused on driving increased adoption and preparing for future launches I look forward to highlighting their continued progress moving forward.
In summary, 2022 was an important year for neuro links as the team worked hard to change some of the historical trends and build a solid foundation for future growth I am pleased with the progress that was made in 2022 and want to thank my commercial colleagues and the entire cross functional Puma organization.
The team is passionate about the work that we do and committed to finding more opportunities to support cancer patients along their journey.
I will now turn the call over to Maximo for a review of our financial results.
Thanks, Jeff.
I will begin with a brief summary of our financial results for the fourth quarter of 2022.
Please note that I will make comparisons to Q3 2022.
We believe is a better indication of our progress as a commercial company year over year comparisons.
For more information.
Recommend that you refer to our 2022 10-K, which will be filed today and including our consolidated financial statements.
In the fourth quarter of 2022 we reported a net loss based on GAAP of $5 6 million or 12 cents per share.
This compares to a Q3 2022 net loss was <unk> 4 million or one cents per share.
Our fourth quarter 'twenty 'twenty. Two result include an increase in our legal accrual due to a lawsuit settlement of $12 4 million.
The full year, we reported net income of $2000.
Our non-GAAP basis, which is included to remove the impact of stock based compensation expense.
We reported a net loss of 3 million or three or seven cents per share.
For the fourth quarter of 2022.
For the full year of two head to head to our non-GAAP income was 11 8 million.
Okay.
Gross revenue from the Airlink sales was $65 4 million in Q4 'twenty to 'twenty two.
$63 4 million in Q3, 2022.
As Alan mentioned it net product revenue from Nellix sales was $53 7 million compared to the $54 3 million reported in the third quarter of 22 and two.
We believe our Q4 net sales included approximately $2 6 million of inventory build from our distributors.
Royalty revenue totaled 12 million in the fourth quarter of 222 compared to the $2 8 million in Q3 2022.
Our gross to net adjustment in Q4, 2022 so about 17, 8%.
Compared to the 14, 3% gross to net adjustment reported in Q3 2022.
Higher Medicaid rebates.
Government charged blacks and higher co pay whereas the drivers of the increase versus Q3 'twenty two.
Yeah.
Cost of sales for Q4, 2022 was $16 8 million.
Including $2 million for the amortization of intangible assets related to our near at the new license costs.
Cost of sales for Q3, 2022 was $12 5 million.
Going forward, we will continue to recognize amortization of milestones to the license more of about $2 5 million per quarter that's caused themselves.
For fiscal year 'twenty two need to me.
<unk> anticipates, a net product.
Product revenue will be in the range of $205 million to $210 million.
We also anticipate that our gross to net adjustment for the full year wanting to nutri will be between 19% and 20%.
In addition for fiscal year 2023 we.
If you'd pay receiving royalties from our partners around the world in the range of $25 million to $30 million.
We don't expect license revenue in 2023.
We also expect our net income for the full year will be in the range of $20 million to $24 million.
Recognize that continues to be a great deal of uncertainty regarding the impact of COVID-19, especially in countries outside of the U S.
This may continue to negatively impact our sales royalties and license revenue.
Historically, the first quarter, representing the lowest net product sales quarter of the year due to a number of factors.
Including inventory build in the channel in the fourth quarter of the prior year.
It has a negative effect on over bottle sold in Q1.
Well as a higher gross to net due to the higher corporate uncovers got expenses that typically occur in the first quarter.
The first quarter sales I'd also negatively impacted by pension delay patients delaying starting to nellix during the fourth quarter of 2022, which drives described.
We anticipate that for Q1, 'twenty 'twenty 2023 now.
Net sales won't be in the range of $43 million to $46 million.
This guidance assumes that inventory is reduced by 200 ball.
We expect Q1 royalty revenues would it be in the range of $4 million to $6 million a decline from Q4.
This decrease reflects the timing of shipments to our partner in China.
We further estimate that the gross to net adjustment in Q1 2023 would be approximately 21 to 21, 5%.
Puma anticipates, a Q1 net loss between two and $5 million.
Yeah.
SG&A expenses were $25 1 million in the fourth quarter was 2022 compared to $24 million for the third quarter.
SG&A expenses included noncash.
Charges for stock based compensation of $1.8 million for the fourth quarter of 2022 compared to 2 million for Q3.
Research and development expenses were 13 point annually in the fourth quarter of 'twenty two.
Compared to $11 2 million from the third quarter.
R&D expenses included noncash charges for stock based compensation Masimo point 8 million in the fourth quarter of 2022 compared to <unk> 9 million for the third quarter.
Our net loss for the quarter was impacted by an increase of $12 4 million legal accrual due to the lawsuit settlement.
The fourth quarter of 2022.
Kumar reported cash burn of approximately $3 1 million compared to cash burn of approximately $17 4 million in Q3 'twenty to 'twenty two.
Our Q4 2022 cash flow included the 7 million payment to Takeda almost made in October.
For the full year, we reported we reported cash burn of $10 6 million.
If we exclude one time cash flows events that impact the 2022 we would have seen positive cash flow of $36 million.
On the expense side.
<unk> continues to anticipate a reduction in total operating expenses in 2022 week compared to 2022.
More specifically, we anticipate SG&A expenses to decline approximately 1% to 3%.
And R&D expenses to increase 628% year over year.
Yeah.
At December 31st 2022, we had approximately $81 million in cash cash equivalents and marketable securities.
Our accounts receivables balance was $40 4 million.
Our accounts receivable terms range between 10, and 68 days while our.
Our days sales outstanding are about 46 days.
We estimate.
As of year end 2022 our distribution network maintains approximately four weeks of inventory.
Overall, we continue to deploy our financial resources to focus on the commercialization of Merrill Lynch.
Development of all constructed and controlling our expenses.
Thanks Maximo.
As noted on our last earnings call. During 2022, we experienced increased face to face interactions with Hcp's and better HCP access overall, which we believe contributed to the increased commercial results that we saw in 2022.
We are hopeful that this will continue to trend positive.
I'm the senior management in cooperation with the board of Directors continues to remain focused on improving their own sales into 2023 and beyond and fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operating cash flows.
We believe that the positive cash flow reported in the fourth quarter was a direct result of these expense reductions. These expense reductions are also a major contributor to the positive net income and positive cash flow that the company is guiding to for 2023.
The company remains committed to continuing to achieve these operational cash flows and positive net income 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 significant unmet need for patients battling breast cancer lung cancer and other solid tumors, we have kumar committed and passionate about finding more 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.
And ladies and gentlemen, we will now begin the question and answer session.
If you would wish to ask a question. Please press star one on your telephone keypad.
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For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Our first question comes from DVR Rao with Cowen <unk> Company. Please state your question.
Okay.
Hi, This is David on for Mark. Thanks for taking our question I guess is there any specific data that you're hoping to generate before meeting with regulators to expand our searches LIBOR in.
Breast cancer, I guess like I said I think the prior guidance was each one to for both small cell and breast cancer. So I guess, that's moved into Q2 or it's too. So I was just wondering if there was any additional data you were hoping to generate.
Yeah. Thank you for the question.
So al sort of as you know is an Aurora kinase <unk> inhibitor and our belief is that you know there's a number of pathways, which we highlighted previously on the call like.
Everyone deficiencies and it seemed like and things like that where we believe that the tumors that express those are going to be the best to target without asserted.
Not yet gotten back a lot of the biomarker data.
The biomarker data from the.
Study of al sort of possible investment my understand that randomized trial, which is alastair a possible investor against Alastair alone.
That has been accepted for publication and we're just waiting for the journal published that the data on the Paclitaxel plus Alistair to against Paclitaxel alone. We recently just got that data. So I think we were hoping for that and again. These are investigator sponsored trial. So they were done by external groups.
I think we were hoping to have that in order to meet with the FDA because we just got it we were.
Is that after the second half.
That's helpful. Thank you.
Thank you.
Your next question comes from Geoff Meacham with Bank of America. Please proceed with your question.
Good afternoon. This is how calling in for Geoff Meacham and thank you for the question. So my first one is really about you know.
For a physician to start patients at a reduced dose and what may be the mi photo.
You have seen and you know well can we do to some of the improved data and digital.
Ah patients starting at a reduced dose.
And then the other language.
Revenue.
What does that mean, then I just wanted to hear if you can provide a bit more color about what sort of drives that a <unk>.
None.
Higher than the prior to call it analysts out there.
On the prior year. Thank you.
Okay on the first one on the reduced sales, Jeff you want to take that yeah happy to thanks for the question I. Appreciate it obviously, we think dose escalation is really important to the adoption of Ratner, then and the risk benefit profile dose escalation has been very well received our teams talk about are consistently its been added to our package insert and attitude.
N CCN guidelines for both early stage and metastatic and we actually see very good discussions and support around dose escalation from our leading breast kols. So the question Youre asking is hey, why aren't we at say, 100% adoption on the graph that we're showing and I'm just giving you some more color around that as we think about physicians, who do adopt and those that don't adopt.
There is certainly a group of physicians largely in the metastatic setting that believe you should start with full dose they want to get full dose immediately upon treatment initiation. So there's a subset that are likely not going to start with a reduced dose.
Number two we do have some physicians in the community that have dealt with niraparib for a long time, but do not have challenges managing diarrhea, and they've got their own way of dealing with it and so they start with full dose and if they have a challenge they dose reduce.
The third situation as we believe the numbers that I'm showing you although that methodology is very consistent it really under calls the complete adoption of dose escalation, we pull that data from our SP channel, which as I've mentioned before is about 80% of our business. So it's a very good surrogate, we do not have visibility into the S. D.
Channel and so for example, if a patient starts in the <unk> portion of the business, it's not uncommon for them to fill one time and the SD channel and then move over to the SP channel for their second and subsequent fills in that example of the patient starts and dose escalation in the S. D. When they come over to the SP. It's.
Likely they'll come at full dose and we'll pick that up as a full dose start even though they started on low dose. So these numbers. We believe are very conservative and quite honestly I'm very happy with the overall trend.
I would guess that the Max that we would ever see I'm estimating it might be 70%, 75% that would be almost full adoption. So hopefully that helps and that's a little more color.
And then on your second question with regard to the royalty.
A large portion of our royalty is the shipments to China and those can fluctuate largely based on things.
Things such as you know as you know.
In China, they had the zero Covid policy.
And so a lot of times. It was you know we were just waiting for kind of the window to open the first to be able to ship. So that kind of causes that fluctuation of that lumpiness to occur. So that's largely why you saw the higher than expected in Q4.
And if I can.
Alright.
So we believe the largest why so large a wonderful country and budget that will become available then with shape as well so.
Okay. Thank you very helpful.
Thank you.
Your next question comes from Gena Wang with Barclays. Please state your question.
Hi, Good afternoon. This is Krishna on for Gena. Thank you for taking our questions a quick one from us so it's.
It's been over a year since you've reduced field clinical specialist Gregg givens.
60% of your accounts.
Interaction I was wondering can you give us an update on how that has been working out do you think you need to add back additional specialists or are you doing well with the current sales force. Thank you.
Yes, I appreciate it thanks, a lot for the question I appreciate it.
Couple of things.
One is as you know the oncology therapeutic area is a very restricted specialty it's more restricted in many other areas I will tell you that since COVID-19, it's become even more restrictive even though we're seeing some positive trends at some of the Covid officers, obviously opening back up so I will tell you.
Right now we feel very good about the size of our Salesforce. They are able to cover accounts that are open and accessible either live or virtual we monitor that very closely and I've said. This on previous calls if we have an opportunity where we're not staffed correctly, we can get in front of more physicians, Alan and I will have a very quick conversation on that.
And we will adjust as necessary.
But right now we feel like we're managing the amount of acceptable accounts and physicians, either live or virtually fairly effectively and efficiently.
As I mentioned, we've seen calls overall calls increased quarter over quarter about 10% and actually year over year about 10% looking at the fourth quarter. So we're happy with the current progress and again in college specialty is a restrictive. So we're also increasing our non personal promotion to try to generate.
Engagement with those conditions that we cannot access so hopefully that helps a little bit.
Very helpful. Thank you so much.
Got it.
Yeah.
Thank you.
Your next question comes from Sahil Kazmi with B Riley Securities. Please state your question.
Hi, Alan Thanks for taking our questions here just a couple from US first of all can you talk about how youre thinking about the opportunity in head and neck squamous cell cancer any color you can provide there as well as the small lung cancer discussions you blanked out with the FDA in the first half of the year.
Yeah.
Yes, absolutely. Thanks for the question and head and neck cancer. So this is a study that's being done.
It's an investigator sponsored study this was ongoing at the time that we purchased the drug from Takeda.
Of using al asserted in combination with pepper, losing that in patients with RV deficient head and neck cancer.
I think we're gonna have to wait and see the data before we can really comment on the opportunity. It's obviously a smaller tumor type.
The trial is just kind of getting going on enrollment. So we'll expect to I would expect we'll probably have data if I had to just ballpark it.
Probably.
Q3 ish this year, that's probably when we'd start to see data.
Hopefully find a conference to present it somewhere in that Q3 Q4 timeframe.
So I think once we get the data and that will leave more than happy to comment on the opportunity.
In terms of small cell lung cancer.
Remember that there's a published study in the journal thoracic oncology of Paclitaxel, plus al asserted versus Paclitaxel alone.
I'll sort of as an Aurora kinase inhibitor. So in a lot of the pathways, which are present in a pretty good percentage of the small cell lung cancer patients, which includes things like everyone deficiencies and everyone's mutations.
Seemed like elevations and things like that that's where the best efficacy was seen and that includes both a PFS benefit and an OS benefit in that trial.
We'd like to have the discussion with the FDA and it's kind of that biomarker directed approach with the drug because our feeling is that is really going to be our opportunity to show you know the best risk benefit the best possibility of showing the most maximal benefit but also something that just differentiates allo sorted.
From the other drugs in small cell lung cancer small cell lung cancer has been a tumor that.
Is largely just consisted of various cytotoxic drugs and you know other than the I O drugs, you haven't really seen a biomarker directed approach in small cell lung cancer. The way you have in non small cell lung cancer.
Non small cell lung cancer, you have you know.
The Egfr mutations the apt mutation Ross ones and things like that.
Haven't really seen the same type of biomarker directed approach in small cell lung cancer and that's really the approach. We're looking to take so that's where the discussion with the FDA is going to focus on.
Excellent that's very helpful. Congrats on all the progress and looking forward to following the story in 2023.
Thank you.
And this concludes our question and answer session I would like to turn the conference back to Mary Anne for closing remarks.
Thank you for joining us today.
Reminder.
Access to buy a replay of the webcast at Puma biotechnology.
Okay.
Sure.
Ladies and gentlemen, thank you for participating in today's conference call. This concludes our program everyone have a great day you may now disconnect.