Q3 2022 G1 Therapeutics Inc Earnings Call
Okay.
Okay.
Hello, Thank you for standing by.
Welcome to the G want Therapeutics third quarter 2022 financial result conference call.
At this time all participants are in a listen only mode.
After the speaker's presentation, there will be a question and answer session.
To ask a question. During this session you will need to press star one one on your telephone.
You will then hear an automated message advising that your hand is right.
I would now like to hand, the conference over to your opening Speaker Leigh <unk>, Vice President of communication will Roberts well. Please proceed.
Thank you Sheena.
Everyone and welcome to the G. One conference held to discuss our third quarter 'twenty, two financial results and business update.
The press release on these financial results was issued this morning and can be found in the news section of our corporate website human therapeutics Dot com.
On this morning's call the team will provide a business overview of the third quarter of 2002.
Including an update on our clinical programs and our commercial progress in that period with the seller, which is approved and commercially available to decrease the incidence of chemotherapy induced myeloid suppression and adult patients when administered prior to our platinum etoposide containing regimen.
But he can containing regimen for extensive stage small cell lung cancer or ESF CLC.
A Q&A session as she has said we will follow the prepared remarks.
Before we begin I'd like to remind you that today's webcast contains forward looking statements within the meaning of the private Securities Litigation Reform Act of 90 95.
Such statements represent management's judgment as of today and may involve certain risks and uncertainties that could cause.
Actual results to differ materially from those expressed or implied by these statements.
For more information on such risks and uncertainties. Please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website.
Any forward looking statements represent our views as of today November 20.
'twenty two.
Joining me on the call today are Jack failure, Chief Executive Officer, Raj Malik Chief Medical Officer.
And preparing our chief commercial officer, and she Moses our Chief Financial Officer.
I'll now turn the call over to Jack.
Good morning, everyone. Thank you for joining us on the call today.
During the third quarter, we demonstrated continued execution on our clinical programs, but also experienced lower <unk> sales momentum versus what we achieved in the second quarter.
I'll cover both in my opening comments and then Raj Andrew will each provide additional color to both topics.
First I'm proud of the progress the clinical team achieved.
As Raj will discuss among the clinical milestones that we've reached during the quarter and since our R&D day in September we announced this morning that we are seeing encouraging initial safety results from our phase two ADC trial with substitute somatic over TTM, which shows its potential to provide clinically meaningful reductions.
Over 50% and adverse events related to substitute some app, such as mindless depression, diarrhea, and potentially even alopecia compared to previously published single agent safety profile of this ADC.
We also completed enrollment in our phase III metastatic triple negative breast cancer trial data for our phase III bladder cancer trial and as we discussed on our last call. The trial the cyclic mechanism of action trial.
Next our phase II <unk> trial results have been accepted for presentation at the San Antonio breast cancer Symposium meeting.
Two abstracts, providing additional non clinical data on trial cyclist potential anti tumor effects have been accepted for presentation at the society for immunotherapy of cancer meeting in November .
Finally, and perhaps most importance our timelines for additional results remain intact for our pivotal phase III trials in colorectal cancer and triple negative breast cancer.
At the same time, we are cognizant of the fact that we did not deliver the level of sales results that we were expecting as youll hear from Andrew we are working through some market variability due to the new patient flow pressure on organizational staffing and account additions at different times of the year.
This was balanced by a 12% increase in reorders from existing accounts.
We are putting in place a variety of actions that future will describe that will drive growth over the coming months.
We hear every day from health care professionals and patients who have experienced the unique benefit that only co sell it provides.
It is a paradigm changing drug that enables oncologist for the first time to proactively reduce or prevent the serious multi lineage hematologic side effects of chemotherapy rather than treating them reactively.
We remain as confident in the potential of cross sell it today as ever.
And as the initial results from our ADC trial underscore extensive stage small cell lung cancer is just the start we are convinced of its potential value to be much bigger markets like colorectal cancer.
Since this morning marks the first of many new clinical data disclosures over the coming months I will first ask Raj to provide an overview of our clinical momentum during the quarter and since our R&D day, starting with an overview of the initial ADC safety results and you will then cover our recent commercial actions.
<unk> results, including an update on the efforts of our field sales team during the third quarter of 2022.
Finally, John will provide the financial results for the quarter, then I'll be back for some concluding comments with that I will turn the call over to Raj.
Thanks, Jack and good morning, everyone. In September we held our 2022 R&D day and discussed a variety of topics, including the timing to the initial results and what to expect from those results and new preclinical data supporting the potential of <unk> to work Synergistically with other anticancer therapies.
We've made good progress on all fronts since then.
I will start with the encouraging initial trial cyclist <unk> phase II safety results in patients with triple negative breast cancer.
That we announced this morning.
We are seeing consistent reductions by well over 50% and the rates of numerous adverse events associated with <unk>. When <unk> is administered prior to the ADC relative to the previously published single agent safety profile of <unk>.
We had hoped to present these data at a medical conference. This fall.
<unk> numbers at the time of abstract submission this summer precluded that.
However, recent enrollment momentum provided the opportunity to evaluate key safety data in the first 18 after 21 patients enrolled to date.
Though early and unaudited at trends in treatment emergent adverse events have been consistent over the time, we have been monitoring the safety results of study.
Specifically.
Some examples of these reductions are in the rate of grade three and four neutropenia.
Which dropped from 52% and the substitute a map data to 17% with trailer cycle assets is a map there.
Rate of any great anemia, which dropped from 40% to 6%.
And the rate of any grade diarrhea, which dropped from 65% to 28% with no occurrences of grade three diarrhea with trial cyclist, <unk> map and 11% in the <unk> data.
We view these as on target effects of trailer cycle not only in the expected reduction in the rate of modest compression related to substitute the map, but also in the rates of diarrhea and potentially alopecia.
This is likely due to the presence of CDK four <unk> expressing cells in the intestinal crypt add in hair follicles.
The other data will continue to mature we are very encouraged by these early on target results as are the investigators who have reviewed the data.
It does it begin to clarify the potential for <unk> in combination with adcs, such as <unk> <unk> across other indications.
In addition, these data could read through to the full Fox theory regimen in our colorectal study, which also includes arena.
We look forward to presenting a more comprehensive safety and efficacy data at a medical meeting in the second quarter of 2023.
Next I'll comment on our pivotal phase III trials.
And preserve one or 326 patient trial of <unk> in first line metastatic colorectal cancer, the primary endpoints or assessments of the effect of <unk> on myeloid suppression.
Paired with placebo as measured by the occurrence of severe or grade four neutropenia during induction and duration of severe neutropenia in cycle one through four.
We expect to release results in the first quarter of 2023 on malware protection and other off target effects of trial, a cyclic life diarrhea, which can be dose limiting in colorectal cancer patients receiving full fox here.
This is a pivotal trial.
Zero protection data readout positive, we will meet with regulatory authorities to discuss filing for approval in this indication.
Next we recently completed enrollment in preserved to.
Our first line triple negative breast cancer pivotal trial in 187 patients with PD lone positive and negative tumors, receiving first line trial of <unk> or placebo private jet side of being a carboplatin.
We expect the interim overall survival analysis to be conducted by our data monitoring committee in the second half of next year if.
If the trial meets the interim analysis stopping rule it will terminate and we will report the topline results.
It does not the trial will continue to the final analysis.
Next let's shift to progress on other ongoing phase II trials.
As we said during R&D day based on the mechanism of action of trailer cycle.
We expect to see the greatest effects on longer term efficacy endpoints like overall survival and progression free survival and the least effect on response rate.
We recently completed enrollment in preserved III, our phase II trial of <unk> in combination with chemotherapy and immune checkpoint inhibitor or value map and 92 patients with bladder cancer.
Initial safety and tumor response data are expected in the fourth quarter of this year followed by data on the primary endpoint of progression free survival in 2023.
As we have said, we do not expect to see mono protection in this trial likely as a result of the gems side have been containing backhaul.
Next our abstract on the initial results of the phase III mechanism of action trial was accepted for poster presentation at the upcoming San Antonio breast cancer Symposium in December .
The San Antonio poster will describe the initial immune endpoint results.
Additional data, including pathological complete response and other immune profiling data are expected in 2023.
In September .
We discuss new preclinical data describing the potential for charter cyclists to enhance the cancer immunity cycle by enhancing T cell activation favorably altering the tumor microenvironment and improving long term immune surveillance.
As Jack mentioned two abstracts on this work have been accepted for presentation at the <unk> 2022 annual meeting and.
In summary, we have made good recent progress and we believe it positions us well for a data rich period.
Finally, I also will mention that we recently presented new data at the precision oncology summit that continue to demonstrate a real world impact at Casella can have on severe hematologic adverse events and supportive care needs.
And railroad practice Casella is used in a heterogeneous population of extensive stage small cell lung cancer patients.
Despite this heterogeneity cassava consistently shows the potential to reduce the occurrence of modest oppression supportive care utilization and chemotherapy dose reductions and delay.
With that I'll turn the call over to Andrew for a commercial overview, Andrew. Thank you Raj I'm glad to be with you today to provide an update on a number of topics, including third quarter sales performance factors affecting growth and a description of some of the actions we're putting in place that will drive growth going forward.
The third quarter was our second complete period during which <unk> was promoted solely by our own team of Gigamon oncology sales account managers. Following the termination of our co promotion agreement with Boehringer Ingelheim and March.
Our goal last quarter was to build on the platform of volume growth, which we demonstrated in Q2, we delivered similar volumes in Q3 years generated in Q2 and I'll discuss some of the factors affecting growth.
Beginning with sales activity, we ended the quarter with $8 3 million and net sales of two seller, representing approximately flat file volumes compared with Q2.
Volume growth compared to the same quarter last year was 129% demonstrating the overall progress we have made with sales execution.
As you May recall, we sold quarterly growth of approximately 60% in Q2 of this year compared with Q1, but when we report <unk> results. We remarked that the small cell lung cancer market can be variable from month to month due to patient flow and pressure on staffing of health care organizations at different times of the year.
We've reviewed the most recently available patients patient level claims and we estimate that the number of new extensive stage small cell lung cancer patients declined around 10% in the first two months of Q3 compared with Q2.
As a reminder, the extensive stage small cell lung cancer market, our quarterly growth is highly reliant in gaining new patients either from new accounts are from existing accounts in order to compensate for patients who complete a chemotherapy regimen of drop off therapy.
Similar to the same quarter last year, we added fewer new accounts in Q3 than in Q2.
However, we did increase the volume of vials of Reorders from existing accounts by around 12%.
We also added seven new top 100 organization since the end of Q2, giving us a total of 64 of the top 100, which have arbuckle sell up modestly.
As a result, our overall estimate of course, our patient share in Q3 actually increased nearly 8% in the first line market, which represents the majority of our use.
We saw 71% of volume in the quarter come through our community clinics and hospitals and 29% of volume from academic centers, representing an uptick in demand and academic centers this quarter.
98% of our volume in the quarter within commercial supply with 2% provided through our patient assistance program.
So our Q3 performance was driven by the managed numbers of new extensive stage small cell patients in the market and fewer new accounts added which together resulted in fewer new kusama patients. However, this was islands by more depth of Reorders and existing accounts.
Our payer mix remained stable with the majority of covered by Medicare part D. Reimbursement has remained strong.
That's how our brand awareness among oncologists remains high and intention to prescribe face to face calls continue to compose the majority of sales engagements in Q3, and our measures of sales force effectiveness continues to exceed oncology industry norms.
Looking forward into Q4 with several new top 100 organizations, having only recently come on board. We are moving quickly to ensure an initial trial becomes advocacy and then adoption.
And reviewing opportunities for further improving execution in Q4, we introduced territory level sales incentive goals for the first time, so that all of our sales account managers are highly incentivized to deliver growth in the quarter.
We introduced new marketing claims, including patient reported outcomes, which many oncologists believe it a pivotal reason for considering to sell.
We entered into negotiations for volume based agreements with several large community oncology provider networks with one already finalized.
We anticipate beginning to see the impact of these in Q4.
We also recently expanded our Speaker Bureau, and competed and completed our first live speaker training since launching <unk>.
Finally, we made some operational changes, including territory realignment, resulting in one of your territory, making 33 in total.
Overall, this was a quarter, where we sustained our high levels of execution demonstrated in the prior quarter. Despite some challenges in flow of new patients.
Going forward, although we anticipate some variability in month to month patient flow of 64 of the top 100 organizations and well over 500 accounts in total with Kosawa experience.
Our customers strongly believe in the benefits of cross sell it for their patients and many are ready to share those experiences with their peers.
Places us in a strong position to ensure that when new extensive stage patients are diagnosed they have the opportunity to receive cross sell them.
Together with our new and more patient focused marketing resources territory level sales incentives and select volume based provider network contracts. We believe we are well positioned for stronger growth moving forward.
With that I'll turn the call over to Jan for a financial update.
Thanks, Andrea and good morning, everyone as will mentioned full financial results for the third quarter of 2022 are available in this morning's press release and will be in the 10-Q, which we intend to file after market close.
Our total revenue for the third quarter of 2020 to $23 6 million comprised of net Costello revenue of $8 3 million and license revenue of $15 3 million for.
For the same period in 2021 total revenue was $4 9 million included $3 4 million of net product revenue for Capella and $1 3 million of license revenue.
The license revenue from the current quarter is primarily related to revenue recognized from two development milestones related to the <unk> license agreement, including a $13 million milestone payment related to the approval of <unk> in China.
Cost of goods sold for the three months ended September 32022, with $1 1 million compared to <unk> 6 million for the same period in 2021.
Our research and development expenses for the third quarter of 2022, or $19 6 million compared to $21 1 million for the third quarter of 2021 the.
The decrease in R&D expenses was primarily due to a decrease in costs for manufacturing active pharmaceutical ingredients and drug product to support clinical trials.
Our selling general and administrative expenses for the third quarter 2020.
$24 4 million compared to $24 3 million for the third quarter of 2021, comparing the two periods. We saw increases in personnel costs due to increased head count and administrative costs offset by a decrease in medical affairs costs commercialization spend and professional and technology costs.
Regarding our cash position as described in the press release. This morning, we ended the third quarter with cash cash equivalents in marketable securities of $123 million compared to $221 2 million as of December 2021.
We have amended our agreement with Hercules to provide additional flexibility with our covenants and have extended the timeline, we are able to drive a $25 million available to us and <unk> of 2023.
With that I'll turn the call back over to Jack for some closing comments Jack Thank.
Thank you Jen, Andrew Raj and will and as always I want to thank people living with cancer for Huron exploration drive <unk> toward our goals every day.
Before we move to Q&A I, just want to recap some of the points that you have heard today.
We are very encouraged by the initial safety results from our phase III <unk> ADC trial will substitute a map that shows its potential to provide clinically meaningful reductions of well over 50% and numerous adverse events related to SaaS to some apps such as viral suppression diarrhea, and even potentially alopecia alopecia.
We expect to provide initial results from our two ongoing pivotal trials in CRC A&P NBC next year, starting with CRC data in the first quarter of 2023.
And from two additional phase II trials later this year.
The <unk> data will be presented at San Antonio and the bladder cancer data will be issued via press release.
We experienced lower closed cell of sales momentum versus what we achieved in the second quarter largely due to variability in patient flow and why we saw fewer new accounts coming on board during the quarter. This was offset by double digit growth in existing accounts reordering.
We've already initiated actions, including territory level of sales incentives. The addition of patient reported outcomes in our marketing materials and volume based agreements with several large provider networks. We are confident that this will drive stronger for solid growth over the coming months.
Given the lower <unk> sales momentum I do want to comment on our expectation for the remainder of 2022.
As I said, we feel confident in the actions that we have put in place to drive a solid growth rate and we intend to provide formal guidance as soon as we have enough data on performance and impact.
We anticipate that we will drive growth in the fourth quarter of 2023 over the third quarter as these initiatives roll out and we expect that they will be effective as we head into and through 2023.
Thank you for your time. This morning, we will speak again in this format on the fourth quarter and full year 2022 call and as you've heard today, we will have a variety of opportunities to communicate with you regarding initial data from our phase II and phase III trial at medical meetings, starting later this quarter and continuing throughout 2023.
Hi.
With that I'll close the call and turn it over to Q&A.
Operator would you please remind our listeners how to ask the question.
Thank you yes at this time, we will conduct a question and answer session.
A reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced.
Please standby, while we compile the Q&A.
Okay. So our first question comes from the line.
From Needham and company your line is open.
Hi, good morning, everyone and thanks for taking our question.
Maybe a first one for Andrew.
Never thought of small cell lung cancer is seasonal.
These I mean.
Pretty aggressive when patients go on therapy immediately can you explain kind of.
Maybe the dynamic here.
Yes, Thanks Gail.
I agree with you I think once diagnosed and obviously patients can progress very quickly I think though there is a bit of a process and picking up those diagnoses and we do hear from health care providers.
The presentation of the symptoms of the lead to a diagnosis or more likely at different times of the year.
We just signed as I said in the patient claims data that we looked at or Q3 that are available so far that thought as bahram true and those data that there was a decline of around 10% and new patients receiving any kind of therapy for expensive stage in Q3 and nine of course, it's just hard to get hold of health care staff during that period.
Product as well, so really a combination of those.
External factors that led to fewer new patients going <unk> in Q3.
Okay.
That's helpful and a couple of questions.
Barrage first one can you maybe put in context, the significance of the recruiting AE.
The specific ADC that wood.
Do you think that talks will lead to desktops, usually lead to reduced amount of treatment.
Hey, Joe Yeah. So that's certainly what we're looking for in this study so that model protection and better Tolerability will allow greater exposure, which would then allow greater efficacy of <unk>.
There was actually a paper presented at <unk>, which showed a good relationship between exposure of fidelity to response so.
So that is exactly the rationale behind conducting the study.
So encouraged by what we're seeing from a safety perspective, so far.
Okay, and maybe a last one.
So the activity of <unk>.
You've mentioned briefly.
Additional evidence.
Diarrhea.
Got related tops.
Very common dose limiting toxicity across chemo.
Yeah.
Something that we've been following actually we've done some work ourselves there was a.
A paper published which showed that using a <unk> inhibitor can actually reduce radiation induced toxicity.
<unk>.
The hypothesis is that the stemlike sells in the intestinal cribs are dependent upon CDK four six for replication. So.
So the similar protective mechanism that we see in the bone marrow could apply in the Gulf as well.
I think Sn 38, as you know is obviously it causes a lot of diarrhea.
And so we are encouraged by the early signs there and as you also know we pointed out in my remarks that arena <unk>, which is of course, the parent drug that gives rise to Sn 38, and as part of the pulse oximetry regimen.
As also causes diarrhea that regimen. So it will be very interested to evaluate what happens to diarrhea, and the colorectal trial also.
Alright. Thank.
Thank you for taking our questions and good luck John .
The rest of the year.
Thanks Scott.
Okay.
Operator.
Oh.
Please standby for the next question. Our next question comes from Daniel from RJ asked Dan Your line is open.
Hey, thanks for taking the questions.
On the.
The initial results that they are sharing today for.
The combination of.
Trials Circlip ahead of <unk>.
Could you could you provide some more context for those 18 patients in terms of response rate and that cohort how that compares.
Two I guess the second study.
Or.
The number of cycles those patients had actually.
Received.
Of the agency based therapy.
And how that compares to maybe the.
Median four cycles of therapy that they were getting.
Our median sorry, six to seven cycles that they were getting in the ascent study I think what we're looking forward to the subway are compared.
And understanding whether there's a table that you have presented today.
Is within the context of.
Drug exposure that those patients would have gotten in the comparable study. Thank you.
Yes, Hey, Dave Raj here, yes. So in terms of responses, we have seen responses in the study first of all yes.
As I mentioned the enrollment in the early part of the study was actually pretty slow.
First patient was enrolled in January so we do have some long.
Term data to evaluate safety. However, the bulk of the patients actually have come on in the last say three plus months.
So it's really still early to make a true assessment of what the response rate could be.
<unk>.
But.
Clearly as you know toxicities like neutropenia, and diarrhea do happen early on and is enough patients that received.
Enough cycles for us to make that.
Make that assessment and that was the reason why.
We thought it was important to put up these data, but ultimately the goal.
As you know and as Gil also asked us to extend the duration of therapy on <unk> to allow us to not only potentially improve responses. Although as we've mentioned before we don't really anticipate seeing an improvement in responses based on the mechanism of action.
It's really more on extending those longer term events such as PFS.
Sorry to.
A follow up on that what was that for the 18 patients that you included in the preliminary safety data set.
What what were the.
The criteria used for including them in that and that are valuable cohort.
In terms of <unk>.
Exposure.
To substitute some have come together.
Thank you.
Yes patients had to have completed at least one cycle on therapy.
Yes, I'd received 70, the combination of trial out plus successes amount.
Got it.
Do you have a breakdown of how many patients were.
Now are included in that table that had more than one cycle of.
Yes, it is Matt.
Yes, actually the vast majority have had more than one.
Okay.
And you can disclose what the <unk>.
<unk> for that cohort I don't think people are really looking for you to be better or they just want to make sure of that but it's a table at comparable which then validates that.
The A&D Cross comparison that you are trying to make.
Yes, Dan.
As I said we've.
I think there is a difference between exposure from a safety assessment and exposure from an efficacy assessment.
Even though with <unk> some of the responses happen early like in the first cycle. There are significant number of that happen with additional cycles. So yes.
I think it's really hard to make a call right now from an efficacy status by the response rate standpoint, I think the data would really not be mature.
So all I can comment as we have seen responses. So we're encouraged from that perspective.
And of course, we are interested in seeing that as well.
Before we put out these data.
So let me directly answer that question. So let me ask you this way which might be helpful to people on the line.
It sounds like to be comparable in terms of.
Drug exposure of the ADC to ascend.
These patients at 18 data that you have here still need more cycles of this.
<unk> got the <unk>.
So plausibly the AE table Youre showing could go up and some of these rates.
Do you have an idea of.
For the comparison to ultimately of the cohort what you think is clinically meaningfully different for some of the key event rates febrile neutropenia, thrombocytopenia or whatever you want to pick.
That would be the target product profile.
That youre, hoping for with this study.
Yeah. So.
As I mentioned, we've been following the safety data right really right from the beginning right. That's what you do in any trial and.
And so the rates for both the neutropenia and diarrhea have remained relatively actually consistent with what we've put out there.
With additional patients that have been enrolled youre absolutely right. The numbers are all definitely change.
With increased.
Just with more patients in general and definitely with exposure potentially as well.
But it has been consistent from kind of from the beginning.
In terms of what are the most meaningful aes, where we would hope to show an improvement neutropenia and its consequences, including febrile neutropenia.
Of course, I think I think diarrhea is.
Really intriguing early finding I would say.
And if you look at the.
At the SaaS. It is amount label. It those are the two warnings on the label so.
That's something else that we're following closely of course very encouraged with the effect on in EMEA as well, which speaks to set up the multi lineage.
Early indicators of effect here.
Last question for me just when do you expect.
To complete enrollment did you did I understand that correctly that you have 21 enrolled now so you'd still need 24 to hit the enrollment target in the study.
Yes, yes.
Yes, we are talking approximately 40.
But potentially even.
Yes, Andrew.
Hoping that by the end of the year that will have the required number of patients but.
And we will present as I said the.
The safety and efficacy data set in the second quarter of next year, that's our target.
Thank you.
Sure.
Thank you Dan please standby while we.
The next.
Question.
Okay. Our next question comes from Ed.
From H C Wainwright.
Your line is now open.
Good morning, Thanks for taking my questions.
You had mentioned.
In the third quarter that diagnoses were down.
Yes.
It could be due to some seasonality.
What is the historical trend for the for the fourth quarter as far as <unk>.
Diagnosis goes do you have any of that information towards small cells.
Lung cancer.
Yes, thanks, Jonathan.
I'd say that the way we track it is through patient claims so it's really patients going onto therapy for the first time lots of effectively diagnosis. So its patients going onto a topside platinum what people with the model that we track.
Looking at seasonality and it.
It can be very most of the month, we see for example in August with our our best month launch to date within the quarter that within a relatively flat quarter. So it can it can certainly be very month to month looking back at Q4 of last year. We then show growth quarterly growth in Q4 last year I think of around 20%.
But clearly there are periods, particularly towards the end of Q4, where there might be some seasonality but.
Overall Q4 last year contained also some of our highest months of upfront. So we believe with our improved capability in the marketplace that we have this year and with some of the new tactics that I discussed we are looking forward to a good Q4.
Okay. Thanks, Andrew.
And a couple of questions for Jan R&D expenses were down the last two quarters sequentially.
SG&A expenses were also down sequentially. The last each of the last two quarters I just wanted to know if we can get at any of your thoughts.
On the fourth quarter.
Yes, sure Hi, Ed Yeah, I would say I think we're going to be in line I would expect R&D actually to be a little bit higher next quarter, just because we're coming up on data readouts scenario.
And as we do.
Indeed, the dads and everything like that.
To add cost, but as these studies wind down at wind down that complete or just having sites and patients that were not having to pay par anymore. So those costs will continue to come down for SG&A I would expect it to stay pretty in line with what we have not anticipating any major changes there.
Thanks, Dan and can you give us any guidance on.
Cash runway.
Sure. So I think before we had given guidance into 'twenty four.
In light of the fact that guidance is based on a couple of things that utilization.
Ladies and of the $25 million from Hercules, which we havent pulled down yet and also our continued sales ramp up quarter.
Quarter over quarter as Andrew just delayed too we are seeing more.
Variability in the sales line, so not giving guidance to 24 at this time, although we do have scenarios that get us there.
Okay. Thank you Tim that's all the questions I have thank you.
Okay.
Thank you Ed please standby within next question.
Our next question comes from.
Pam.
Your line is open.
Hi, This is Malcolm Qunar for Autopart Robyn.
Thanks for taking the question.
What are.
Some of the key marketing hurdles or pushback that you are hearing.
In terms of getting new prescribers.
Onboard with Costello.
Yes, Thanks, Bob.
<unk> remains the same that we've been dealing with over the last year or so which is first of all understanding they expand the problem of myeloid suppression because those reduction has become a way of life in the course of core spot.
Domestically effectiveness.
Chemotherapy treatment.
We know how real world evidence that's been presented at conferences, which is that our promotion, which shows with thousands of patients in the real world. The true extent of myeloid suppression and it really is an incredible burden on patients.
Real consequences in terms of hospitalizations et cetera.
So we feel we're in a good position from a marketing perspective to tell that story.
The next part is with many of these organizations. They do have complex processes to get a new product and to consistent use and so moving from trial to adoption, usually evolves going through high risk patients that may be the first patients that they trial with seeing that benefit in that patient and then wanting to use it with all.
<unk> patients to do that you have to go through a formulary process on EMR ambition or percent admission and it can take some time to work through that and suddenly in Q3. It was tougher to move from trial to adoption just because gapping all of those staff members together, having all of those conversations meetings appointments means taking time.
<unk> available to do that because of.
Seasonal vacation forever.
<unk> slowed the process down.
And then finally, we have to make sure that we are persistent in our efforts because not many providers see a bulk of expenses based small cell patients who we have to get out there we have to expand our peer to peer efforts, we hope to expand our digital efforts and we've actually made incredible strides forward over the last few months with that not only are.
But still efforts, but as I mentioned before expanding our Speaker Bureau, having that first life. The life life Speaker training. It was fantastic to see the energy in the room from our speakers who have experience with the wholesaler as they really advocated with their peers for it and we're looking forward to sharing their real World studies.
Great Thanks for that background.
Thank you please standby for questions.
And the next question comes from David <unk> from Wedbush.
Your line is now open.
Hey, Thanks for taking the questions two quick ones first could you remind us what whereas.
Are there any other support agents neulasta or whatever allowed.
Four patients in the Triple negative study and then.
As a quick follow up.
And the <unk>.
Ascent study.
Neulasta I think what's allowed after the first cycle of <unk>.
Is.
Do you know if if there are continued problems with neutropenia.
If you were to prophylaxis with.
G CSF for what the rates might be.
Yeah.
We are of neutropenia in patients who might have.
A pretreatment with it thanks.
Hey, David This is Raj, yes, so we allowed.
<unk>, including <unk>.
Growth factors and transfusions and so on.
And Youre right that it was also allowed in the ascent trial.
I'm trying to recall, what proportion received G CSF I seem to recall around.
Yeah, I think in that kind of range.
So yes, so that's something clearly we're following as well in our study, but given the lower rate of neutropenia, we would expect that to be.
Lower proportion and the combination with trailer.
Yes.
And did any patients did any patients receive it so far on your in your study.
G CSF.
I'm not aware.
Of that yes.
Okay. Thank you.
Thank you.
Please standby.
Question.
And our next question comes from Cowen.
Cowen and company.
Line is open.
Hi, everyone. Congrats on all the progress and thanks again for taking my question. So I just have two questions on <unk>, maybe one for Raj and then one for Andrew.
So first on the CIC data next quarter can you just remind us of your expectations for the data and maybe like what level of neutropenia reduction would make you all feel excited.
And then for Andrew on opportunity in CRC do you all have any idea how the top cuts all accounts compared to those.
<unk>.
Youll see a lot of overlap there and if so do you think you could possibly penetrate the market much faster given the established relationships that you already have at some of these centers.
Hey try this is Raj so I'll go first.
So this is a phase III trial and we have.
Obviously defined the.
Sure.
The stats in a way to see that see the reduction right. So just to give you context.
For color for colorectal with full Fox series based on the trial data, we expect a grade four neutropenia rate in about the 20 odd percent rate. So.
The trial is designed to show a statistically significant reduction over that and if we meet that I think thats going to be clinically meaningful.
So I hope that that helps answer your question I think that would be exciting because as you know the major hurdle.
For continuing full Fox here is really model the toxicity.
So if we're able to improve upon that we believe that's going to be a benefit for patients.
Yes.
And on the second one yes, I do think there will be significant overlap and that will be particularly in the community staffing where community oncologists really really see all comers, who will have a specialist within the network within the office, but very often they will see multiple tumor types I think in the academic center centers that will be a little different.
And we will have to engage with them through our medical affairs organization as well as commercially to be able to get to those folks, but I do think a lot of CRC is treated in the community. So I do think that there will be overlap overlap. There also in terms of the speed of uptake probably the single biggest bang on the west less.
<unk> jump in there.
They are today as we I know you're going to get more tumor types I want to be able to use us with more patients.
So I do think that we will see some some early adoption and people who just become more familiar with wholesale up by having multiple tumor types and indications so.
Our customers are telling us they are incredibly excited about our future potential and we can't wait to deliver that.
Alright awesome. Thanks, so much for all the color that helps a lot.
Operator, you muted.
Thank you my apologies.
Our last question comes from Tony <unk> from Roth Capital. Your line is open.
Yes.
Thanks, very much good morning.
Raj.
Well I've got just three brief questions Raj.
If we go back to.
The triple negative breast cancer data for triple with <unk>.
Treatment interruptions, if you just do the straight math from the label.
Earned 63% of patients.
Which lead to.
Treatment interruptions in roughly half of 47% if you actually run the numbers on the 18 patients five patients would have would.
Would have.
At least.
Would have that dose interruption is there is that why you're making the statements about a reduction of 50% upfront.
I'm trying to frame. This correctly. That's question one if I may question to Andrew I believe in Q2, you made reference to.
Sales reps, having some level of increase in face to face contact.
If I characterize that correctly is that the same in Q3 as an increase.
Are we in the fifth inning.
You would have expected to occur.
Or is it too early to say.
And then finally do you get data.
Yes.
Is it only after the fact.
On surgeries per center or do you get it.
As granular as the type of surgery per center.
You look at sure.
Data on a quarter to quarter basis, thanks very much.
Hey, Tony This is Raj.
So, yes, I mean, I think thats, certainly dose delays dose reductions as something we're following very closely obviously ongoing study, but we are encouraged by what we've seen to date.
Because all of the color I can provide at the moment.
And I'll, just then Tony on the <unk> face to face over 70% of our engagements are face to face. It has gone up markedly since we introduced our new sales team, which is fantastic.
First thing is I mentioned it before but.
Although we saw.
Access to our customers a little bit limited in Q3 because of the seasonal variations our share of voice actually remained stable Julien.
During Q3, so that basically means the all companies had limited access to customers during a period, which again lends itself to be the fact that there is some seasonality there but but.
But overall, we've been very very pleased with the ability of our folks to get to.
The customers have substantive face to face discussions.
In terms of a last question I'm not sure if I was quite tracking with you and maybe maybe Raj can answer that but we don't track any kind of surgical procedure data.
Commercial staffing.
So.
Added to the fact that.
Small cell lung cancers were down 10% in Q3 is that the way.
Mike did I correctly here that so you had to actually track something.
Yes.
Formation about.
Surgery.
So whether or not it's diagnosis or otherwise I assume all of these patients will have surgery.
No great Great point, thanks for the clarification actually so it's based on claims data for a Tulsa say platinum with or without <unk>.
Okay.
The presence of a diagnosis of expensive stays in the vast majority of users about regimen. That's obviously extensive stage.
How do we judge that so it is basically a paid claim for the <unk> regimen will tell us how many new til LN patients are existing in the marketplace, but it is not related to the surgical procedures that would accompany that.
I understand thank you very much.
Thank you Tony.
I would now like to turn it back over.
To add to the CEO Jack Bailey for closing remarks.
Thank you operator, and as always we look forward to keeping you all updated as we progress certainly thank you for joining US today, please stay well and we'll be in touch.
Thank you so much this now concludes the call.
We will now disconnect the lines.
The conference will begin shortly to raise Johan during Q&A, you can dial star one one.
[music].
Okay.
[music].