Q1 2022 SCYNEXIS Inc Earnings Call
[music].
Yes.
Greetings and welcome just an extra thank first quarter 2022 wanting sponsors calls.
At this time, all participants are in listen only mode.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.
I'd like to turn the conference over to your host Debbie Atkinson from Investor Relations.
Please go ahead ma'am.
Thank you Hello, everyone and welcome to today's conference call to discuss our first quarter 2022 financial results and corporate update.
Before we start let me remind you that today's call will include forward looking statements based on current expectations, including statements concerning our financial outlook for the future leadership expectations for future financial and operational performance as well as our business strategy, because such statements are subject to risks and uncertainties.
Actual results may differ materially from those expressed or implied by such forward looking statement. Please.
Please refer to our filings with the Securities and Exchange Commission, including our most recent annual report on Form 10-K, and quarterly report on Form 10-Q, including in each case under the caption risk factors and in other documents subsequently filed with or furnished to the securities and Exchange Commission.
All forward looking statements speak only as of today May 12, 2022. So that's just undertakes no obligation to update such statements to reflect events that occur or circumstances that exist. After the date on which they were made the information on today's call is not intended for promotional purposes and not sufficient for prescribing decision.
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Joining us today on our call is <unk>, president and CEO , Dr. Margo tackle yeti.
Chief Commercial officer, Christine Cohen Chief.
Chief Medical Officer, Dr. David Angelo and interim Chief Financial Officer, Larry Hoffman.
Following our prepared remarks, we'll open the call to your questions.
Now I will turn the call over to Dr. Marco <unk>, President and CEO . Thank you Debbie good morning, everyone Bryan Jordan to Steve. Thank.
Thank you for joining us today for our first quarter of 2022 earnings Investor call.
We are excited to share with you updates on the progress of the launch of <unk>.
And to outline our vision for the future, Okay, Hey, Brexit from drug franchise.
222 is a pivotal year for St axes, and we are making great strides. Let me briefly summarize a few key recent accomplishments in New York.
Turn goals.
On the R&D side, we continue our successful efforts to expand the labeling Alibaba schlanger.
We expect to file the <unk> NDA for that according to BBC indication. This quarter, we have an approval by the end of this year we.
We reported positive results from the new interim analysis of the field Fortean kiosk trials, highlighting all based upon jeffs potency against severe fungal infections with more than 83% of combined patients demonstrating a clinical response to our library.
Joe.
Finally, the Mario study is being initiated and we expect the first patient to be enrolled.
It Might've studies expected to report the results in 2024 with a potential approval for hospital indications by end of 2024.
Total dividend, our Chief Medical Officer will provide you more details on this program and the positive results to date.
Our first commercial product <unk> <unk> tablets.
Through September 2021 achieved nearly 4000 prescription at least you can make the revenues of $700000 in the first quarter of 2022.
We saw a promising growth claim in the first quarter of 2022, as we continue to boost our efforts to accelerate sales this year and beyond to reach.
Our Chief commercial Officer, Christine Cohen will discuss this set of coordinated and integrated the actions that we are taking to grow prescriptions from field sales force to launching a direct to patient campaign.
On the corporate side, we closed the first quarter of 2022 with more than $95 million in cash.
Extremely fortunate and very thankful to our investors for being able to recently to strengthen our available cash with $45 million public offering which will enable us to advance our goal of building a broad antifungal franchise for it but I can have one.
Across multiple indications.
I would say fortunate.
Cause strengthening our cash situation will allow us to navigate successfully through the quarter on let's call. It environmental challenges of today's World a war in claim.
A war in the heart of Europe , the pandemic that we opened but we don't know yet if it's older inflation higher interest rates and whatnot.
Having secured the cash to fund our corporate activities into the first quarter of <unk> 24 puts us in a strong position.
In fact based on our cash we currently have better services to support our commercial efforts and BBC, including preparing for the launch in 2020 free of recurrent BDC and we have the resources to complete our hospital programs to enable additional regulatory filings in 2024.
And by the way. We also continue to look for business development deals like the one we did with hansel for greater China and for other non dilutive ways to strengthen our cash balance.
I would like to underscore that our vision to make <unk>.
First one sustainable and profitable antifungal franchise is becoming a reality.
But actually if I'm now approved and launched for the treatment of BDC, We plan to expand its label in by end of this year as I mentioned to include the prevention over call. It the BDC we have.
Diligently and successfully following our plan to athene, each key milestone along our path to build a broad long lasting antifungal franchise.
All of these indications.
When taken together will create the franchise with the potential to generate $700 million to $800 million a year in net sales in the U S alone.
Larry our interim CFO will provide more details on our expenses and cash boss.
And then we will open the floor for a Q&A session.
Now I would like to turn the call over to our Chief Commercial Officer, Christine Christine. Thank you Monica and good morning in August 2021, our field reps began calling on their physician target.
<unk> interest in learning more about <unk> was encouraging.
Charles on pharmacy shell, and we began to see doctors prescribing breadth of them. They are off to a strong start all while our insurance coverage up commercial lives continued growing and tracked ahead of schedule.
However over the winter, we saw growth trends slowing mostly because of environmental factors like the omicron ways that affect that the commercial sales force of many other companies as well.
Therefore, we have been putting even more effort into critical success factors, such as reach and frequency of visits to high prescribing HCP.
We are now seeing a positive gross churn picking up at a good pace.
Our messaging about the benefits of Brexit that is resonating with prescribers, which is great news, we will continue to refine our messaging as we work to broaden our prescriber base.
At the same time, we are increasing our patient outreach efforts based on field response to these initiatives. We are seeing these efforts, having a positive impact that will help us achieve our target payout.
Now, let's look at some numbers.
Over the last few quarters, we built a base of Brexit 10, prescribers. Our focus is to continue broadening out the prescriber base and helping those doctors to expand their use with more patients.
Grew our prescriber base about 10% in the first quarter of 2022.
Especially with the number of repeat writers growing to almost three times the level as of fourth quarter 2021.
Repeat prescribers contribute the majority 56% of Brexit than volume in the first quarter 2022 versus 28% in the fourth quarter of 2021 over.
Over the last few weeks, we have generated learnings from these repeat writers and we are applying these learnings to all prescribers.
Brexit been prescriptions group continued to grow over the last quarter, we generated almost 4000 prescriptions in the first quarter of 2022, representing growth over the last quarter of 2021.
The first quarter prescription growth came from adding new prescribers and broader adoption among fourth quarter 2021, prescribers, we continue to see steady progress each month and are encouraged by the most recent growth trends.
Our commercial coverage continues to steadily tick higher as payers recognize the benefits and value associated with Brexit that.
By the end of the first quarter of 2022, we successfully garnered coverage of more than $93 million commercially insured lives.
Representing 55% of the commercial universe up from the 48% of commercially insured lives reported last quarter.
We expect continued momentum on this front as our discussions with our payer customers are signaling justice.
Our national account directors are very experienced with expense extensive payor relationships and strong coverage numbers are a demonstration of how important the non azole option of Brexit event is to payers and their patient numbers.
Now that we have built payer coverage, we are coupling it with a new campaign called say no more.
This campaign was launched with HCP as in April and prominently features <unk> and iconic imagery paired with new data and messaging.
Our next step is to amplify our collective outreach to patients and consumers. Starting this month, we will reach out to patients with the same no more campaign.
We have been talking to patients deepening our understanding of what motivates them.
Based on these findings we have changed language used to describe the key attributes of Brexit them to be more powerful and more robust.
Our new patient materials are much more about empowerment, which resonates with our target audiences.
<unk> out later this month will be digital advertising, social media advertising and much more.
They know more is becoming a rally cry for these patients who have been suffering with east infections and trying the same thing to help alleviate the symptoms.
Okay, no more Brexit.
Brexit then it's time patients had a new option.
The same no more patient advertising will activate patients and consumers seeking health to learn about Brexit symptom relief and to ask their doctor for Brexit them.
As our field teams solidify their efforts with our key prescribers, we will monitor our augmented patient efforts and amplify those with the greatest impact. We know physicians are pleased with their experience with Brexit.
And we look forward to reporting back on our patient.
While our field teams do their work and we let the patient awareness programs rollout. We have also taken this opportunity to launch additional communication vehicles to create a surround sound of communication. For example last week, we implemented a satellite media tour with two of our spokesperson.
Dr and catchy.
<unk> Vice President of medical Affairs at some excess and Barb Dean also known as nurse Barb and expert nurse practitioner.
The persons to up to 26 television and radio stations highlighting the importance of vaginal health any advancements made by Sonexus and appeal.
The call to action for the successful effort was twofold.
Viewers to go to Www Dot Yours D health Dot com for more information on the latest advancements to fight east infections. The Urls redirect <unk> dot com in order to drive traffic to the site.
And we encourage them to atherectomy Keith about the new product that kills East. These are just a few of the television stations in the key markets across the country, where the segments are and will continue to air during the month of May.
As you can see we have efforts across multiple channels that will continue to expand over the next few quarters. These times are exciting indeed.
However, we are pleased but we are not satisfied it is clear that we have brought a long needed nonnasal option te's infection traders, but thats not enough. We must continue to consistently remind our breakfast and prescribers not to fall into old habits, and we must continue adding new prescribers to our base.
We know when we do this we see positive impact while our field team's focus there we will get these patient outreach efforts out harmonizing all of these promotional levers will help us to continue to drive growth. We look forward to reporting back to you on all of these efforts.
Thank you and I will now turn the call over to Dr. David <unk>, Our Chief Medical Officer, Dr. Finkel.
Thank you Christine.
As previously announced we completed our phase III study candle evaluating <unk> for the prevention of recurrent vulva vaginal candida asc's or out of EDC.
It's also a positive showing significant and sustained response with otrexup longer fitment with these results. We are now on track for submission of a supplemental NDA by end of this quarter with an anticipated approval by end of this year.
In this study <unk> was well tolerated there would've no serious drug related adverse events and no patients treated with exit exit from the discontinued therapy due to adverse events. The most commonly reported adverse events were headache, industrial designate events, which were mostly mild and generally consistent with equivalent Rexam label.
In addition, we recently reported positive outcomes in patients with refractory BBC treated with automated except from data from the ongoing phase III study fueling.
These results were presented during the annual meeting of the American College of Obstetricians and Gynaecologists eight coke.
Next a homegoods showed efficacy in difficult to treat patients that have BBC, a refractory to standard Antifungals data. Please.
14 patients with refractory DTC was treated with otrexup longer.
750 milligram 73 days for three doses.
71% of them had successful clinical outcomes as judged by the independent data Review Committee.
In the hospital setting as you know we are developing otrexup longer to address critical unmet needs, including in basis under the ASC.
Refractory fungal infections in invasive aspergillosis.
We have initiated the module study evaluating otrexup will net us a step down therapy in patients with invasive Candida, yes.
We anticipate first subject enrolled this quarter.
The cares in beauty study evaluating <unk> in patients with Candida, auris infections, and refractory fungal diseases continue progressing well.
We estimate having data available from these three studies by early 2024.
Supporting an NDA submission and an anticipated approval later that year.
The phase II study in invasive aspergillosis inertia will continue until the end of this year and the next steps of development will be guided by the data from these studies.
As you know the beauty and the curse of studies are open label and allows the opportunity to do preliminary evaluation of the outcomes of the patients enrolled would be very difficult to treat infections.
And we recently reported the results from the last interim look at the data from this study.
With now more than 130 patients reviewed in these studies, we are very pleased to see that the response rate as evaluated by the external group of experts continues to be positive.
More than 60% of the patients achieved complete or partial response, and 22% achieved stable disease, which is a favorable outcome in cases of progressive from an infection, resulting in more than 80% of patients experiencing a clinical benefit.
The results were positive in both the <unk> study that includes patients with dividend formula infections and in the care study focused on patients we drove multi drug resistant candida.
The most common pathogen reported in this group of patients include formula strength, commonly associated with anti four Mega systems, such as <unk> in Canada.
The consistency of these data with previous analysis gives us continued confidence of the potential utility of <unk> in these established steady.
Final lead or key milestones associated with our development pipeline remains on track and we continue developing <unk> for multiple indications as discussed previously.
And now let me turn the call over to Larry Hoffman or.
Interim Chief Financial Officer. Thank.
Thank you David for the first quarter of 2022, Brexit from generated $700000 of net revenues as a reminder.
Through our recording revenue upon the sale of inventory to the wholesaler.
Revenue amount represent sales notable discounts to insurers also includes any discounts from patient assistant programs like our co pay card, we expect our net selling price to improve over the course of the year.
Cost of product revenue was 100000 for the first quarter of 2022 R&D.
R&D expense for the first quarter of 2022 decreased to.
The $5 7 million from $6 $9 million versus the comparable prior year quarter.
G&A expense for the first quarter of 2022.
An increase of $14 6 million from $6 7 million.
Versus the first quarter of 2021.
The increase of $7 9 million was was driven by an increase in commercial expenses related to the ongoing commercialization of Brexit.
Total other income was $9 6 million for the first quarter of 2022 versus total other expense of $2 million for the first quarter of 2021.
During the first quarters of 2022 and 2021. So next is recognized.
Noncash gains of $10 million and $1 $3 million, respectively. When the fair value adjustment of warrant liabilities and non cash gains of $1 million on a fair value adjustment of derivative liabilities.
Net loss for the first quarter of 2022 was $5 5 million or 17.
Basic loss per share compared.
Compared to a net loss of $4 7 million or 18 basic loss per share for the comparable prior year quarter.
As Marco mentioned at the start of the call we have a strong cash runway into the first quarter of 2024, we.
We have cash and cash equivalents of $95 2 million as of March 31, 2022, with an additional $45 million received in gross proceeds.
Which approximated $42 million net after certain costs and expenses, which we received from our common stock offering in April 2022.
Our partnership with Handsew provides us with.
Yes.
And an additional potential of $112 million in future long term development and commercial milestones and <unk>.
The strength of our patent protection ongoing business development efforts provides us with additional opportunities.
Internationally.
Before we begin the Q&A I will turn the call back over to Marco Marco.
Thank you Larry.
Before we open the floor for <unk>.
Any session I want to reiterate a few key points.
First I cannot stress enough with banks that they brushed upon <unk> unique first in class systemic antifungal with great potential a product around which we can build and we are building long lasting franchise, helping patients in both the community and hospital settings.
Second we have started to build the franchise by launching breakfast BDC in September and Brexit premium is making great strides with HCP and patients and this is only the first of multiple potential indications for a Brexit from Joe as we anticipate expanding the labeling to include the recurrent yeast infections.
By the end of this year.
Sure.
Our R&D pipeline is extremely robust and we expect to enroll the first patients in our Mario trial this quarter.
And we anticipate regulatory approval of our first off little indication for the Brexit vote in June .
End of 2024, as an oral step down therapy from visa candidacies and for some of the setting in refractory invasive fungal infections.
For not only we can build a broad antifungal franchise, but it is a franchise that will last for a long time since we have exclusivity protection.
<unk> 35.
Finally, we are in a strong financial position with a cash runway into the first quarter of 2024.
And now let me finish with our rallying cry Eastern Factually say no more I hope you will love.
Our <unk>.
Rallying cry and now operator, please open the floor for questions.
Thank you Phil.
At this time, we will be conducting a question and answer session.
I would like to ask a question. Please press star one on your telephone keypad.
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One moment please poll for questions.
Well I'll ask a question, ladies and gentlemen, please press star one now.
Okay.
We have our first question from the line of Michael Higgins with Ladenburg Thalmann. Please go ahead.
Thanks, operator, congrats guys.
On the continued progress thanks for taking some questions with all the activity we split the ongoing launches I wanted to start with a theory curious Dan if I could.
What are your thoughts on the response rates when you compare them to other novel phone calls.
Many patients do you at this point project will be in the NDA for <unk>.
Thank you Michael this is David.
Yes. The response rates that we're seeing right now this is a salvage therapy <unk>. So we are very very pleased with the response rates, we have been disclosing that for the past year and we're seeing that a more than lets say about 60% of patients having complete or partial response is very very positive for people who have been already failing other therapies or other therapies have not abated.
To them. So in comparison to what has been reported and the established therapy setting. We are very much on target to what we expect is the response rate for that for this particular population as you can see here.
<unk>.
Cases, so the response rates observed in <unk> against Candida Auris has been I would not say so priceline group has been very very good who has been really very good responses to and carried out. These cases that we didn't have too much benchmark information forward because those are new new diseases that we were just following very closely to see how it shakes out.
Work on that so we are very very pleased with the result that we're observing in these in this group right now the plan is to complete the.
As you can see there to really wrap up doses studies by next year. The estimated enrollment for these studies has been as you can see in clinical trials of Gulf of about 200 subjects were estimating to enrolling <unk> about 30 subjects to enroll in tiers and we believe that we are on target for completion of that enrollment.
Within that within the time is that we are disclosing right now.
That's great ill double check my notes, we were looking earlier seemed like we were seeing favorable favorable responses. How it's described in the label of 30% and 40% for the other phone calls when they come out so.
Impressive, but thanks for your feedback on that.
I can switch to Cristina question for you on the breakfast <unk>.
Do you have for us in obtaining the percent of Rx is going to women with RBC.
And has it changed much since last quarter.
Good morning, Michael Thanks for the question.
Talking about the market or are you talking about Brexit and prescription.
Yes, Brexit <unk> scripts, how many are going to refractory patients versus.
On label, Yes, so from a commercial standpoint, Michael you know we stay on label. That's all we can do say the revpar.
Talking to doctors about.
EDC not rbbc, that's really so that's really what we track our description.
I think Michael this is Michael I think youre raising a very good point, it's something that we we may have noticed is the fact with the.
Are some of the patients.
Technically classified us as in accordance with the CMA, just simply patients where the phone just static effect of Fluconazole doesn't just clearly infection. So the infection with a fungistatic. We've when you start to gauge until like fluconazole or either easels.
The camera continue to stay lingering around and then when will give time, Canada will start to grow. So we believe that the one will be greater advantage of our product is really the <unk> silo effect with kiosks with Canada cleared to be infection and really becomes in a cure so.
You may have patients with wind being afflicted by visa recurrent infection, but possibly they may not.
Treatment and cure of their infection for goods. So that is one of the things, but we expected with the product with our profile would be able to achieve.
Thanks, and one last one if I could hear any update for us on synergies.
That's enrolling.
Yes. So thank you Michael this is David again, yes, the synergy trial as we have disclosed in the past really the enrollment has been lower than initially projected.
Have you received the feedback from the centers that during the past couple of years with the Covington EMEA bring with the focus in that particular study was difficult for them. However, during this year, we have seen much more activity that we saw in the past few years. So we keep we really keep it.
Speaking with investigators and really.
As we disclosed we will continue enrollment during this year really trying to wrap up all the information that we have by the end of the year and really make a decision regarding subsea.
Subsequent development for invasive is in beta pulmonary aspergillosis is specifically based on that data that we are looking forward to really reporting those results later on but we continue enrolling at that particular site.
Thank you Michael.
Okay.
Thank you.
Gentlemen to ask a question. Please press star followed by one on you touched on for now.
We have next question from the line of Louise Chen with Cantor Fitzgerald. Please go ahead.
Hi, this is weighing on for Louise Congrats on the progress this quarter and thank you for taking our questions. Here. So my first question is on the competitive landscape how will the recent approval of Mike Colby.
<unk>, Colorado uptake of the <unk>.
That's limited.
And then how is the relationship with empathy or they are planning to expand the Salesforce and my last question is are there any distribution on market access challenges that are either in the uptake of <unk>. Thank you.
Well. This is a very good question Wayne where can we start with the first one.
Talking about the competition and to my call here.
Well first thing I want to say is that we.
Happy to see that.
Innovation in the field of PVC.
Do you think about it in the last three decades, but there's been nothing new coming for patients with PBC, despite the well known limitations of Easels.
So two approvals in this field in the last 12 months.
Great news for all women suffering with this condition.
And we wish him well to our colleagues Michael here.
Our two companies have taken different paths, we decided to develop a unique product a new class beyond easels with a very favorable safety profile, we welcome mutual restrictions or limitations.
Moreover, we expected it to when Brexit will be approved for according to CDC at the end of this year. It will be the only product approved for both the treatment of BDC in the prevention of it according to BBC within easy dosing.
And we have an indication for a broad range of patients both in terms of age from 12 years old.
And beyond and also in terms of women of childbearing potential. So we expect <unk> to continue to remain very.
Cognize major innovation in the field of BBC.
With regards to your second question about the amplitude.
Our relations with empathy is very clear that as we they are a contract commercial organization. So we are hiring a sales force fully dedicated fully dedicated to.
So I want to make to always be is very clear.
And the one of the reason we decided to have these type of approach instead of our own sales forces because having an organization like Apple to give us flexibility eventually to span.
When needed to be.
The sales organization without having to to build internally and labs.
Our structure.
Sure.
So <unk> is there to help us to be successful and as you know this is a partnership where we have.
An agreement that will allow us also to defer some of the costs in the near term.
And finally about the distribution of distribution actually.
Sure.
I mentioned <unk>.
We better has been really one of the areas, where our supply chain has been working extremely well.
We are we were able to get the product in the pharmacies actually end of August beginning of September .
I would like to remind you of that.
<unk> DNA actually is a manufacturing company what the company has been for probably two decades. So we we.
We know how to do.
Develop.
Produce manufacturing product and the supply chain has been has been actually quite successful in making sure that the product was available in all of our pharmacies and we don't see any issue with the pharmacy, but the let me absolutely efficacy in confirming that.
That aspect so just to make sure I didn't Miss anything that you did not thanks, Michael Hi, Wayne Thanks for the question.
Youre absolutely right Mark that we did not have any trouble getting the product in Q.
Shane and over it into the retail pharmacies that were in the call footprint of their apps to win second question can we see any abstraction.
As it relates to the 15 adjudicated.
For the patient and the Doctor right, we have not seen that signal I mean, we've enjoyed really good access with the 93 million commercial lives and we opened up from last year into this quarter. So I think thats really helpful. We also have our co pay.
Support program for now thank you pull them out that launch and they start to wind down as our la at commercial lives covered we're in a really good spot we do not see a signal of a distraction there we watch it very closely Wayne.
Yes.
Our charges, let Monica talked about which is and ensure that the reps are in front of their high prescribing call targets. Every time, we do that when we get the intended result, which is broader utility and bringing on new prescribers, that's where we focus for now and that's my first point, we're always looking to see where do you go after that at in at relative to.
<unk> of your footprint that we're always looking at that right now coming out of the first quarter with some of these COVID-19 office closures, we're doubling down with our high prescribers, because thats, where we get the results, but thats some helpful information.
Thank you Christine.
Thank you congrats again.
Thank you Lynn.
Thank you.
To ask a question ladies and gentlemen, Please press star one we have next question from the line of Kumar Roger with Brooklyn Capital. Please go ahead.
Hi, I'm tremendous mark.
Thank you for the update.
I was just wondering if you could provide some color to the.
The ongoing.
Phase III studies like how many sites are you planning to activate and do expect all of the sites come onboard at the same time.
Thank you.
Sure. This is David Thank you for the question. So incident first the second part of your question on all the sides going to come out at the same time now typically in this very large global phase III study is really the different regions that are coming.
Different time, because everyone has kind of a different regulatory timelines for approval and we are planning to conduct. This study at this point, we're doing we're wrapping up the final feasibility assessment of all the geographic regions that theres going to be a global study that will involve.
European centers centers in Asia centers in the United States et cetera, and the initial centers had been already open. So we already have sites open for enrollment.
And that's why we are confident in our ability to really being able to enroll our first patient within this quarter. So we're just waiting for those the first patient to come in and but we already have sites opened.
For initiation of enrollment.
The total number of sites that we are estimating at this point.
It's going to be in the in the round of between 70 to 80 sites globally and Thats. What we are currently currently plan.
Okay. Thank you, yes that was helpful. Thank you.
And so you had some preclinical data with Nucor Mycosis <unk>.
So how are you planning to take it to the clinic you didnt have any patients enrolled.
Or a combination therapy in the ongoing <unk>.
Thank you.
Yes, we do have patients enrolling compete with combination therapy for other fungal diseases rare, although rare pathogens, but not for immune <unk>.
We recently as you pointed out do we recently conducted this preclinical investigations in which we observed that we need a combination that appeal.
<unk> seen me with apex of hunger had surprisingly good results in this in these mice mice models of musical mycosis with that information that has been recently just reach out to the scientific community. We made a confirmatory study even with deepening the strengths of the <unk>.
And we observed the same trend again those results were recently presented at <unk> again, and we are now.
The investigators of the <unk> study, we are not behind them and now they have the opportunity to enroll patients with nucor into into into the study.
In the past, we were not enrolling patients with new core because we knew we had very limited information regarding the potential clinical utility of <unk> and you understand these patients have a very very high mortality you can only allow them to participate in your trials. When you have very good reasons to believe that you can benefit them.
Now we are opening the study for them. So we are looking forward to really start seeing how some.
Some of these patients may get enrolled and instead of seeing some clinical activity from from that particular indication as well, but this is an extraordinarily exciting data for us even if preclinical because of the significant unmet need in that in that condition, the very very high mortality.
Anything that can help these patients to survive is really extraordinary goodness.
Thank you just to be clear, so youre opening the PV CRO floor.
These patients will nickel Michael suspicion.
Yes, so Neil Koehler.
Medical patients can be right now enrolled in immediately we didn't need to modify the political the political already allowed that.
What's the specific that there are certain pathogens, even they are not defined by name in the protocol in which the product could be.
The bulk of D.
Our resource for them, we can allow them to enroll in the <unk> study. So the study <unk> allows right now enrollment of the Neocart patient.
And we will keep you there.
Stay tuned we'll keep you updated.
In the future if we have patients enrolled.
Yes.
Okay, great. Thank you so much looking my questions.
Thank you.
Thank you we have next question from the lineup Oren <unk> with H C. Wainwright. Please go ahead.
Thanks for taking the questions.
Couple the first on <unk> and then a follow up on the CRE.
CRE cares program so on <unk> it sounds like there's a change of messaging you mentioned.
Focusing on empowerment and detecting.
Change or some specific focus on high prescribers, you've mentioned a couple of times and I'm, just wondering am I wrong.
Reading too much into the language or has there been some change in strategy with regards to resource allocation and targeting perhaps.
Are you for now at least coming out of Covid backing off of some efforts to broaden the prescriber base and focus more on.
Deepening increasing the frequency of writing within.
Quote unquote high prescribers.
And then I'll ask a follow up after thanks.
Hi, Orin.
Morning, Christine. Thank you for the question that you heard you've heard my words, but I want to make sure that unclear at the high prescribers and I think union is very well our most prolific writers there largely obgyn and they're the first adopters everything we thought about in prelaunch happened gasoline commercialized today they continue those.
High prescribers continue to be really important to our base.
Some of the offices, we did we did experienced office closures in the first quarter like many other companies because of Covid and so we saw some inability to get in there as frequently as our call plan call for so then when we look at as as offices open up in February and March and beyond you start to Crs being able to get in.
In there or and then you see us come back online with that prescribing rate, which is what we're looking for so no change in strategy continuing executing the plan and chest.
Making sure as often as we are able to get into those high prescribers.
And as far as the messaging the messaging is that in terms of changing that.
Refining messaging for <unk>.
Patients primarily or is the.
Pitch to doctors changing as well.
Okay.
Right, Yeah, So I mean, we've been out there.
Vacating for nine months and at the same.
We'll learn from the ground up with the field teams that will get to report back from our reps. So thats one one.
Point of information the other point is over that course of time, we do our customer listening exercises to see how the messages that we've crafted initially are going and so all it is is zoning and refinement based on this it's really rounding the edges, but I think on the slide hopefully you got to see the slide.
The imagery is more evocative and its more provocative or and we're trying to get higher memory ability. After the rapid leads the office.
Kind of what Youre seeing there on that pay no more slides.
Imagery, we kind of bumped up a little bit Orin and then just refine the messaging based on customer feedback. So no change in strategy, there just rank and file aggregate out.
From launched nine months 12 months, you learn a lot from what your customer is saying or doing after we give them sort of in a message and so that's what that's what I'm talking about here alright.
Alright. Thanks.
I may for Mark and Mark go ahead David.
Youre, putting some specific goals out there with regards to the timing of data from Purion carriers, but also an approval by.
By end 2024 so.
Could you clarify that presumably using the L pad pathway and if so can you talk about any additional conversations you've had with the FDA on that front just to help us understand.
Have a lot to go on or precedent in <unk> could you help us understand what youre thinking in terms of what you need to show what.
What kind of indications and specific or broad.
Use cases could you imagine thanks.
Thank you Alan this is David.
Yes.
Yes, the intention as you can see there.
Online is to really aligned the completion of the module study that is going to be kind of a randomized double blind study in invasive Canada, you said steady and to align that with the data that we're going to be heading from acuity and cares.
And clearly to try to get an indication that is broad that may allow us to really use the OLED <unk> stepped down from an IV chemo can be income from the module, but also to be able to use either excess longer as a salvage therapy patients that are not responding on that so that they can order antifungal agent.
We believe that the most likely scenario is going to be narrow to invasive candidiasis salvage therapy, because it's where the majority of our patients are buying now in beauty and exclusively candida infections candida infections in cares.
Note that the <unk> study enrolled at this point a great variety of different.
But the majority have been handling patients and so that is there is a current thinking that really these two pieces of information will be complementary to each other to enable a broad label a label that allows you to use as a step down in a patient that is let's say.
Net net refractory and resistant to step down normal patient with invasive candidiasis from <unk>, but also solid state upbeat in those patients not validate that or not responding to other basic.
Basic Canada yet.
<unk>, a very significant unmet need for other diseases, let's talk about <unk>, we were to have some experience with new core order from the leases that we have already enrolled patients in but for which the numbers at a still limited is difficult for me to say with the very strong confidence if the data is going to be.
A large enough for the agency to consider expanding potentially you're considering the label expansion into those conditions.
But that I feel very confident because at least from my point of view the number of patients. There is an invasive candidiasis in both of these studies have been.
Consistently data very consistently reported in these cases.
The favorable outcomes. So that's the <unk> strategy.
And we have discussed with the agency regarding combining these data sets can be based packages, we have not come to the final.
Good evening regarding exactly what it's going to be the final analytical plan over there toward the end of 2023. However at this point, we do have a conceptual agreement of the data pieces of information that could substantiate and approval in this setting.
Thank you very much I appreciate it good luck.
Thank you Oren.
Okay.
Thank you.
Again to ask a question box plus stock.
Star followed by one on the Dutch drone for now.
Okay.
Thank you ladies and gentlemen, we have reached the end of the question and answer session and I would like to turn the call back to Mark <unk> CEO .
CEO for closing remarks over to you Sir.
Thank you very much.
Operator.
I will lead us to square some very quick very.
Very quick point 2022 is a critical year, we started very well in all the three major areas launching Brexit firm with very positive trend.
Great data in the hospital setting and a solid solid financial foundation to make sure that we have the resources.
<unk> supports all our efforts with a cash runway into 2020, we couldnt start the 2022.
Any better.
So thank you very much for your attention and for your support.
Operator, Thank you very much you can close thank you very much.
Thank you very much.
Ladies and gentlemen, this concludes today's conference.
You may disconnect your lines at this time, thank you for your participation.
Okay.
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Okay.
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