Q3 2021 SCYNEXIS Inc Earnings Call
Greetings and welcome to the <unk> third quarter 2021 earnings Conference call.
At this time all participants are in a listen only mode.
A brief question and answer session will follow the formal presentation.
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As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Debbie Edington Executive director of Communications. Thank you you may begin.
Hello, everyone and welcome to today's conference call to discuss our third quarter 2021 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.
Such statements are subject to risks and uncertainties actual results may differ materially from those expressed or implied by such forward looking statements. 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 included in each case under the caption risk factors and then.
Other documents subsequently filed or furnished to the securities and Exchange Commission.
All forward looking statements speak only as of today November 10th 2021, So Nexus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist. After the date on which they're made the information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions.
Joining us today on the call our Sonexus, President and CEO, Dr. Marco tackling Eddy Chief Commercial Officer Christine Cohen.
Chief Medical Officer, Dr. David Angelo.
Chief Financial Officer, Eric Francois following our prepared remarks, we'll open the call to your questions now I will return the call over to Dr. Marco tackling Eddie.
Thank you Debbie good morning, everyone. Good morning, Jordan.
Thank you for joining us today for our third quarter 'twenty to 'twenty, one earnings Investor call, our inaugural earnings call with investors since the FDA approval in June and after the launch of Sofia.
For all of you who have been following the eyes in the last few years you weakness, how we have been true to our word commitments and timelines to them our vision for a Brexit from Joe into reality.
Our vision for the based upon Jeff has always been to build a global antifungal franchise for both community and hospital infections by leveraging this activity and potency of a breaks off one Jim and distracted with full value of this unique Hispanic antifungal.
Agents for the benefit of patients and for the reward of our shareholders.
And we have a 14 year exclusivity until 'twenty 35, we have the time to build the solid long lasting antifungal franchise to create extreme of approval. So there'll be years to continue to expand its use.
So today, you will hear about the significant progress we have made so far in achieving our vision, what abid I have one job.
First you will hear from Christine our Chief commercial officer will provide an overview of the market our commercial activities and the promising early trends of the launch of Brexit foam for the treatment of vaginal standardizes.
We are very excited about bringing innovation for me in new antifungal class to be millions of women suffering from these symptomatic condition, we're been underserved for so long.
We're proud to bring to patients the first the new antifungal class in more than 20 years.
You will hear from David <unk>, our Chief Medical Officer about our significant progress in research and development. We are finishing the phase III tandem study for the prevention of Rick with BDC, which assuming positive data may result in a second approval for it but I saw in the second half of next year.
David will also give you an update about our liposome, an intravenous formulation, we successfully completed with phase one in healthy volunteers opening new avenues of development for hospital invasive fungal infections on top of our ongoing hospital programs.
And finally, all our commercial and R&D activities are built on a solid financial foundation.
Eric <unk>, our Chief Financial Officer will give you a brief financial update.
Now I would like to turn the call over to Christine coin to Steve. Thank.
Thank you Marco and good morning, we have several exciting commercial updates to share with you today.
Following the FDA approval abreast of fan in June.
Our team hasten the launch efforts of bringing a truly innovative product to market and to the millions of women who suffer daily in the U S.
Vaginal yeast infections are extremely common with about three out of four women experiencing them at least once in their lifetime.
Despite the high prevalence of D V C. There had been eliminated advancement in this area of women's health for decades until now.
<unk> is a truly novel first in class anti fungal with a mechanism of action designed to kill the east, causing the infection, including azole resistant strain.
<unk> brings long awaited innovation to the market and physician feedback has been excellent.
Health care providers confirm that breastfeeding is meaningfully different from the outdated coal they have been left to use for the last two decades.
Physicians are excited about the novel mechanism of breath defense and its fungicide all properties.
They are delighted that breakfast is a non azole oral one day dosing alternative for patients.
<unk> are just saying great thing they are changing their long held habits and prescribing <unk> for their patients.
From the beginning of launch we have closely monitored physicians motivation to prescribe.
These early indicators of motivation has converted to action.
These indicators are quite strong and encouraging.
Now let me provide more details on the progress we've made since our launch this summer.
First we establish the foundational building blocks that set the stage for commercial success.
Together with <unk>, our contract commercial partner, we rapidly hired trained and deployed high performing sales representatives and regional sales leaders post approval.
Just in excess in amplitude collaborative partnership has allowed us to efficiently leverage <unk> deep expertise and experience to achieve our strategic vision for Brexit them.
<unk> is a great partner.
Equally realized the importance of this launch and what it means to access and to physicians and patients.
At this time, we are continuing to execute our launch plan, which includes our sales teams consistently promoting Brexit then to their physician targets.
As we have discussed previously the U S.
S. BBC prescription market is nicely concentrated and need for strategic and executable approach, especially this early in launch.
Effectiveness of efforts is the name of the game at this juncture my.
My expectation is that we continue expanding our prescriber base in breadth and depth.
And the team is focused on just that.
All indicators confirm that our efforts are working.
Just to remind everyone on the call the history of our launch process by August the product has been manufactured packaged and distributed to pharmacies.
Then our sales force has been hired and trained and the commercial launch was formally announced in September.
Sales started to come in as soon as the drug was available in pharmacy in August, which we believe highlights the pent up demand for an alternative to evolve like Brexit them.
We started to achieve real significant traction now and in September and we continue to see an upward trajectory in October.
According to <unk> data there were 1006 total prescriptions for Brexit and the first partial quarter of the launch.
This is in line with our expectations.
As physician awareness and experience increases so does the adoption of Brexit them.
We see a very consistent week over week growth rate of prescriptions from early August to the end of September with nearly 700 prescriptions in September 11th.
There is a similar trajectory of growing positive momentum continuing into the fourth quarter with itvs, showing 1100 Brexit than prescription in October alone very encouraging indeed.
Yeah.
Prescriber feedback remains aligned with what we learned in our prelaunch research.
Having a new non nasal option with a novel mechanism of action that has shown activity against resistant strains of Canada, while rapidly eliminating signs and symptoms of the infection continues to be important to physicians and patients.
In addition, the ability to provide a one day therapy is also extremely compelling.
Health care providers are motivated to prescribe Brexit them and we are starting to see repeat prescribing physicians broaden their practical experience.
As our sales teams continue to generate awareness and utilization of Brexit than our national.
<unk> account directors are busy continuing their work with commercial payers we.
We have presented to numerous payers, we have discussed contracts and we are in the midst of negotiating agreements with key payers.
As of today coverage of Brexit, then has grown to over 30% of commercial lives and is still growing.
We are actively engaged in ongoing contract negotiations with additional payers, representing the majority of commercial DTC patients.
Progress with payers have yielded not only schedule P and K pharmacy and therapeutic reviews, but also contract discussions and negotiations I'm delighted with the efforts and results have been Payor national account teams. They have strong customer relationships and deep tenure in this space based on all of this we are.
On pace to meet our goal of tier three coverage non preferred.
Okay.
We will begin educating and activating patients early next year prelaunch ratios research showed high patient motivation based on the strong attributes of Brexit them.
Similar to the positive physician reception, we have been experiencing we expect consistent response from patients and the marketing team is working hard to deliver compelling patient education materials in 2022.
It is incredibly fulfilling to bring a new product to market that addresses an unmet need where there has not been a new development in a long time and where there was high frustration about lack of scientific advancement in this area until now.
The response, we are receiving from the medical community is encouraging and extremely satisfying.
Look forward to reporting on the team's continued progress in 2022.
Thank you and I will now turn the call over to Dr. David Angulo, Our Chief Medical Officer David.
Thank you Christine.
But hitting these positive trends regarding breaks up and commercialization activities I will be sharing with you. Some updates in our development programs. Please keep in mind that the programs that we will be covering in this section.
Any indications that are not approving bricks FM labeling.
Potential indications for diabetics, a phone corp under clinical development with a vision to maximize the potential for a novel agent to become a blockbuster antifungal addressing multiple unmet needs in the market, we have been making significant progress on several development programs for David except from her first let me start with a quick update on our revolver.
<unk> Candela Ics or <unk> program.
After securing the approval of <unk> for the treatment of BBC with order two pivotal <unk> trials, we continue progressing on BBC development activities with our ongoing candle phase III trial.
Candle is intended to support an indication of prevention of recurrence in patients with recurrent BBC as.
As you May recall, we have previously announced the completion of the study enrollment and I'm happy to report that we are on target for the last subject last VC by end of this year.
We anticipate availability of top line results early in the second quarter of next year.
<unk>, followed by a super mental NDA submission shortly after.
And with a potential FDA approval of a new indication by the end of 2022 after an anticipated six month expedited review by the FDA.
Moving into the hospital based indications we are quite busy and we have some great news to share. The first exciting update relates to the intravenous formulation of diabetics suffer.
From any strategic drug development at some point anti infectives benefits from having both an IV and an oral formulation Fortinet show inpatient hospital IV treatment and the ability to shift to auto ones. The first one is discharged from the hospital to continue therapy in the home setting we completed.
Dosing in our phase one study that included multiple those spaniel's with up to seven days of dosing.
That tolerability of these newly purchased almost elimination was clearly better than previous formulations tested there were no serious adverse events and the most common adverse events were mild redness swelling and pain at the site of infusion the.
<unk> analysis is ongoing and we are in the process of outlining the subsequent stages of the development plans for the intravenous formulation.
We believe that these study results could be game changing for our company as an IV formulation may significantly expand the potential opportunity for diabetics iPhone curve and increase its strategic interest in the product.
Or fueling cares program aimed to provide treatment options for a fungal infections for which there are limited or no. Other treatment options have continued to progress well.
These studies will continue running during the next year, allowing us to gather additional information about the potential clinical utility of outbreaks of phone curve in difficult to treat invasive fungal infections.
As you know previous interim looks at the data had been supportive of the potential of diabetics, a phone curve to be a much needed salvage treatment alternative for invasive fungal diseases.
As we expand out of beta and experience with the use of hydraulics a finger in the hospital setting we continue to advance discussions with regulatory agencies regarding the optimal regulatory path and data needed to support a salvage therapy indication.
Our senior just studying.
Evaluating oral <unk> in combination with Vodafone is solid for the treatment of invasive put menotti aspergillosis has not enrolled as rapidly as initially projected.
The prioritization of hospital resources stores that dressing COVID-19 pandemic has impacted the ability of many institutions to focus on the screening and enrollment of patients into clinical trials, including CNET Jim.
Or investigate those set of belly nosed up now with a decrease in the numbers of COVID-19, hospitalizations in some regions. They anticipate having a better opportunity to focus on enrolling patients for this study.
We have made the decision to extend the enrollment timelines into 2022.
Lastly, I want to share with you unexciting, but a clinical development for diabetic cell phone Kurt.
As you may be aware mucormycosis is a devastating fungal infection with a very high mortality rates more than 50% in some situations even with the best currently available antifungal data.
Mucormycosis can become a public health threats when the right conditions are present as an example, more than 47000 cases of these infections have been associated with the COVID-19 pandemic in India.
NIH sponsored preclinical study conducted by Dr. Ashraf EBIT him, a well known expert in the field a substantial improvement in survival was observed in a mouse model of Mucormycosis when a breaks off when we got it was administered in combination with both Soma land for <unk>.
One of the key as standard of care options for these infection. These.
This finding suggests that the co administration of these drugs may be synergistic for the treatment of these infection. This is very encouraging development.
The aim into better elucidate the significant over these potential clinical benefit we now allow combination therapy with <unk> as a treatment option for the new go to Mike <unk> in a few of the study.
Finally, we will be hosting a hospital pipeline update investor call on September sorry on December six to get.
Details about our development progress and plans for the hospital indications please mark your calendars.
Now, let me turn the call over to Eric Francois or.
Our Chief Financial Officer.
Thank you David Let me first term our presentation by highlighting a few numbers on the revenue side. This is our first quarter ever two reported product sales. We are very proud of the progress and excited about it.
As you heard from Christine the launch is proceeding well.
This was a partial quarter for us and we ended the quarter strong and already see indications of a strong positive trajectory of sales in the fourth quarter.
For the third quarter of 2021, it's first quarter post launch breakfast same generated $516000 in net sales as a reminder, we are recording sales as soon as we sell inventory to a wholesaler at launch we worked with wholesalers to stock more units that rolls in pharmacy networks to ensure drug available.
And we expect to have approximately three weeks of inventory on hand at the wholesalers over time.
The next cell number we won't be reporting represent sales net of all discounts to insurers and also includes any impact from patient assistant programs like our co pay card, which is the main impact on Q3 net sales given the early commercial launch.
Please refer to our press release issued today for a detailed breakout of expense line items.
And lastly, cash and cash equivalents totaled $100 1 million on September 32021, compared to $93 million cash and cash equivalents on December 31, 2020 base.
Based upon our existing operating plan, we believe that our existing cash and cash equivalents the sale of our New Jersey, Nols and the anticipated sales of breakfast them will enable us to fund our operating requirements into 2023.
We did not draw down additional debt from our remaining $30 million Hercules and Seb term loan facility in the third quarter, but we will have access to additional capital in 2022, sending reporting positive phase III data in our Kendall, We're currently BC and achieving certain self thresholds.
As we are still early in the commercial launch we are not providing revenue or expense guidance I will turn the call back over to Marco Thank you Eric.
Before we begin the Q&A I want to reiterate.
Few key points first.
Our vision for a Brexit Andrew is becoming a reality.
Second following the approval in June.
Actively executing our commercial our commercial launch plans with very positive trends as we work through.
Third.
Our R&D pipeline is extremely robust and we asked people moving into the forefront now.
Stay tune on December six.
<unk> am eastern time, when we will provide our plans and timelines for the hospital program.
Four we are in a very strong financial position with a cash runway into 2023.
And lastly, just let me take a moment to thank Eric Francois our Chief Financial Officer for these services over the last six years as we announced he is leaving the company to pursue opportunities in banking.
Eric played a key role in transforming <unk> into a fully integrated commercial stage company.
And he leaves us well positioned for success.
We wish him the best.
His next endeavor.
Thank you Eric.
And interim CFO is in place very often one of them.
Pfizer for a smooth transition.
You will meet him soon and we are actively recruiting for a new CFO.
Operator, please open the floor for questions.
Thank you we will now be conducting a question and answer session.
If you would like to ask a question. Please press star one on your telephone keypad.
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Once again, if you would like to ask a question press star one on your telephone keypad.
One moment, please while we poll for questions.
Thank you. Our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.
Hi, This is Wayne who else, where luis and congrats on all the progress and thank you for taking our questions.
Oh, we got to if we may so the first is on your partnership with Penn So forming China could you provide us some updates on the progress and what is your plan on commercializing Brooks.
The other regions of the World and then our second question is <unk>.
<unk> can be view, the first step sports IMAX and now you are commercialized what are the major catalysts, we should be looking out for in the next 12 to 18 months. Thank you.
Thank you and thank you all for your questions. So let me start first of all with the partnership with cancel it has been a great partnership as you know has always one of the top five largest.
Public biotech company in China, We license, we're probably at the beginning of the year they filed.
<unk> four <unk> Candela is China. So they are moving very aggressively with the development of the product in order to ensure approval in China.
Of the product. So we expect just a few on that is what we expect also to continue to progress very very rapidly in the <unk>.
The BBC indication, but also to continue to progress.
Hospital too.
We are of course, we have as you all know rice.
For the product.
Worldwide and of course, it is our plan to commercial to monetize this product in two of our product.
Commercialized outside of the U S.
But of Florida as you can expect following approval in June of the product.
And following the validation of the value of the product outside of the U S.
Partnership with Ham so as you can expect our phone calls I've been intensifying with potential partners outside of the U S. But at this point, we cannot provide any additional information other than saying that we certainly we are moving forward to make sure I address upon job becomes available to all the patients globally.
And finally, yes, BBC is really the first step the first indication, obviously theres some indication with placebo the product.
This program is a great versatility the ability to be used for.
Community type of infection that are difficult to treat like BBC, but nothing that you should necessarily life threatening but also can be used for all spittle indication whether there are any.
Infections of the blood stream of internal organs with high mortality and so we are progressing all of these indications in parallel.
Future catalysts next year, we expect the second approval for vape.
Prevention of recurrence of BBC for Iressa from Jeff, but will allow us to bring in additional indications in the bag of our sales force.
And therefore to be to go out with a new indication to be our current group of targeted doctors, but also we expect to move forward with the hospital indication.
Stay tune on December 610 am Eastern time, we will have a.
<unk> teleconference to share our plans and timelines for the hospital indications. Thank you.
Thank you.
Okay.
Our next question comes from the line of Michael Higgins with Ladenburg Thalmann. Please proceed with your question.
Yeah.
Thanks, guys I appreciate the opportunity to take some questions.
Let me say, Eric Thank you you'll be missed around here.
Couple of questions on the launch that could with with Christine.
How are the commercial coverage.
Is that coming along versus internal expectations, where do you see happening in the next few months.
I've got a handful of them here I'll try to keep this tight so we can talk later maybe.
So unrelated Medicaid coverage, how is that tracking along.
And then finally here are you targeting nurses and pharmacists and and so if so in what ways. Thanks.
Thank you for the question Michael commercial coverage again, that's a little bit about this I think the national account directors are joining us.
A really great job in getting to the payer customers and having.
The necessary conversation, so they've gotten some really great traction throughout 2021.
We've had a lot of meetings with important payers that are important to us. So we are tracking over 30% commercial covered lives right. Now my expectation is that trend continues going in that direction and we'll bring in some imports since coverage by the end of 2021, and then we will pick up the rest in 2022.
As it relates to Medicaid just participating in the state Medicaid reviews that are ongoing we have some stage III <unk> proactively and are again national accounts reactors and our medical science liaison take those meetings and we'll continue watching that as it goes.
As it relates to nurses and pharmacists yeah total we call. The total office call and that includes the pharmacy as well and we are having success. There I should say the representatives are having great success, there with not only the physicians, but their nursing staff and then also rounding back to the pharmacies to ensure that the physician and patient <unk>.
Past experience with Brexit them that they can and that's going very very well.
Hope that answers your question Greg.
Yeah.
And Michael as you said Eric Okay.
Yes.
And Michael just I wanted to say that we've added.
Don't worry it will be around this is a small world. So I'm sure that we will interact with him and you will continue to interact with him. Please go ahead.
Sure.
I'm sure I appreciate that and I look forward to that.
Just one quick follow up on that I'll jump back in the queue I've got some other ones on the IV and the other studies, but just one here on the on the launch.
Any feedback on the Gi.
Is it Big management food what are you hearing from your reps. Thanks.
And now I mean, the reaction from the physicians is exactly what we saw in research. They are really excited to have this alternative <unk>, they've just been waiting for something like this and.
The reception on Michael on the funding side, all the ability that it can kill the yeast infection that can take it in one day.
It's a different mechanism of action really strong reception from our call targets.
Tolerability as you May remember me.
Michael Yes, our clinical trials. So was mild reminder, bank shorter lasting so we've done. This is why we see this reflected in the type of a spread against all of our patients.
Okay. So feedback has minimal on the Gi events.
That's correct.
Okay I appreciate it thanks, guys I'll jump back in the queue. Thank you. Thanks Michael.
As a reminder, if you would like to ask a question press star one on your telephone keypad.
Our next question comes from the line of Kumar Roger with Brookline Capital markets. Please proceed with your question.
Thanks for taking my questions and congratulations on the path to talk about product sales.
So first with regard to the pent up demand.
How much of that has been satisfied.
And also with regard to the.
Physicians that are being targeted.
David has been targeted debt and.
Where is this prescriptions that are coming from what what percentage of it is coming from and what are you seeing any problems like some physician prescribing more than others.
Yes, so thank you.
The pent up demand, yes, so we put stocking into the pharmacies around our call targets. So that our physicians once they started prescribing Brexit and their patients could get the products that we did put that into the channel I think my comments at your questioning is.
Sometimes you see organic sales happened before the rats actually get to in earnest round to their physicians and that's what we were talking about and that right. There is an organic signal of that.
A lot of the work that has been done previous to the sales reps getting out there with the awareness of Brac defense doctors were waiting some doctors are waiting and ready to trial and Thats exactly what happened.
As it relates to the doctors being targeted we did a lotta research in prelaunch identify the territories that would be most advantageous and productive for us to address and you can imagine it was high.
Fluconazole prescription writers and that those are the doctors that we're targeting those doctors.
In the geographies that represent around 90% of PBC prescription.
Market. So it's a very as I said in our prepared remarks, very concentrated territory, which makes it it makes it easier for us to address and that's what we're seeing right now.
Yeah, we are seeing it's really I'm very very delighted and extremely encouraged because part of it is what we do part of it is organic we're seeing prescribers and its increasing month over month, we're seeing prescribers brought in their clinical experience by using breakfast them for more patients.
For me that's the effectiveness of what we're doing in a way of bringing information and education on Brexit fans through our prescribers, but it's also prescribers, having a good experience and wanting to expand to their patients membership. So hope that answers your question.
Hi, Thank you.
And in terms of.
Commercial covered lives.
What's happening in that front in terms of.
Is that having any impact on like the number of prescription and how is that expected to change over time like you know what.
Thinking in terms of prime level itself getting these folks onboard.
Yes, Yes, you are right you expect those lines to kind of travel together, so prescription utilization and covered lives traveling together, because obviously when the doctor chooses Brexit them per his or her patients.
You generate more coverage for those patients that you start to see increases in both of those lines they travel together.
Thanks, So much of course, thank you. Thank you Kumar.
Yeah.
A final reminder, if you would like to ask a question press star one on your telephone keypad.
Our next question comes from the line of Nathan Weinstein with Aegis capital. Please proceed with your question.
Hey, good morning, Margo and Eric Thanks for taking my question and a big Thank you to Eric for being a great CFO and a great person to work with.
So maybe just anecdotally can you speak to the role of the patients themselves can plan of being advocates for breakfast them.
Word of mouth marketing and then also are there any big communities online, where the patients tend to congregate and share information.
Yes. Thank you for the question.
Patients are very big advocates for themselves for their own health and Theres the sequence to how we do these things right. The most important thing in early stages of launches to get the prescriber. The one who has the prescribing ability to understand that Brexit exists and what it is such that when the patient.
Arrived into the physician's office any dove and.
Ask for a product the Doctor then understand what the product is had some familiarity they need to do some research if they have yet not utilize the product, but the perfect situation as a patient walking through the Doctor's office asking for breakfast and then the doctor, knowing what Brexit vendors and having clinical experience.
Practical experience themselves.
That's kind of the sequence you like that that's the sequence you would like to follow.
Do you see patients.
Having conversations with their physicians know we argued in the marketing team is doing beautiful work too.
Educate patients properly and in a good way in a fruitful way in 2022, such that the connection between those patients going into the doctor's offices.
A very productive one sometimes you can habitation come in to the physician's office to physician doesn't know about the product and it really is not a fruitful endeavor.
Hope that helps answer the question.
Yes. Thank you guys converted as thoughtful and helpful answer much appreciate it.
Thank you.
Thank you.
Our next question is a follow up question from Michael Higgins with Ladenburg Thalmann. Please proceed with your question.
Thanks, guys for taking the second round here.
Quick one here for I can't let you off the hook.
Are there any inventory numbers in the Q2 results.
And what should we expect as the Delta on the Q4 pull through.
Yes.
Thanks, Michael as I mentioned in my prepared remarks, we had a higher number at launch to launch to ensure it.
That all relevant pharmacy networks, where had enough drug availability over time and as we mature into a commercial launch.
We want to keep about three weeks of inventory.
On hand, and so thats going to be basically our plan now as we learn and as we get more historical data, we will adjust accordingly, Michael but for now there's just kind of the trajectory that we're taking.
Yes.
I guess, just a follow up to that of the 50 or 60000 or so U S. Pharmacies. How many are you start dealing with at least one bottle.
Yeah.
I'll, let Christine address yeah, you know what.
We stopped.
Stocks.
50% of them early in the launch and then Theres reordering happening. So they are pulling those through now.
I'd have to look and see where we are at this time.
Okay. That's helpful. And then we switched to the IV a couple of questions on that.
<unk> been asked I'm juggling calls here.
Have you done any additional injection site assessments, given the history here with developing an IV Brexit bunker. Thanks.
Sure. Thank you Michael this is David.
Certainly during this.
Study, we were addressing and assessing very carefully what was the tolerability of the intravenous formulation and as I mentioned.
During my remarks. Initially we did have served a substantially better tolerability of these liposome formulation when injected.
In this healthy volunteers. So we did a still of service on mild infusion site reactions typically readiness some swelling, but in no way this prevented the dosing from continuing and Douglas extraordinarily encouraging so from that point of view. These formulations depot formulations is doing well, we would expect them to be.
Doing which is really improve the tolerability of the IV administration of our product enabled us to move it forward to the next stages of development.
Okay.
Next question on the ideas.
It sounded like either in the press release commentary in your prepared remarks that there were next steps that you were considering for the IV.
Sure what that means I would I would expect that you're.
Going into phase II are you planning to run another phase one possibly.
We are at this point.
As you mentioned, we are really doing the final analysis of what pharmacokinetic data.
<unk>.
And we are going to be in a better shape to really show you or tell you exactly what out of the outline of the different stages of the next stages of the development program for <unk>.
Let's say in December ones, we kept all the PK data and our lives in on hand.
If you ask me right now so for me.
<unk> probably phase two is the next stage that we would like to confirm that in December.
Okay.
Thats follow up point here, because it sounds like well, we'll feel this in December.
<unk> for you on the candle.
And maybe this question for maybe for all of you may have seen.
When you think about positive data here from candle what impact do you think that'll have on sales at different time points. For example, once the data comes out doctors can see that and then also following its approval is this something that you envision as kind of a 10% to 25% bump on the current trajectory of sales or something more like <unk>.
80% or higher impact on sales.
So Michael but there is that we have been actually talking about Covid is also in the past.
The real need here, we said treatment they'll BDC with a seen nothing coming for the last 25 years, we expect actually to have some of course to have the opportunity here with prevention of recurrence BBC to try to get another group of patients where these infections.
Almost a chronic affliction and we expect these to contribute to our bottom line, but probably will be a relatively small public pay an additional 10% 15% is what we have been up.
<unk>.
Because really the innovation here is bringing a product with one day treatment kind of really clearly infection. Thanks, Dewey Stefan decided all activities.
And that is really where we expect there'll be.
<unk> Europe, and Brexit for them to make a significant difference.
That's super helpful. Thank you one here on synergy.
You mentioned that.
Covid delayed enrollment in the 22 any plans to adjust the enrollment criteria or execution of the trial given what the CDC in that.
The emerging infectious disease Journal posted this morning.
The increasing prevalence of Aspira losses, among COVID-19 patients.
Any any positive that can come from that for you guys at least things.
Sure no. Thank you for the question Michael This is David again.
Yes, certainly the COVID-19 pandemic has impacted the ability of the institutions to refocus our resources and really enrolling or doing research and a lot of the resources, we're forecasting Colby relate that COVID-19 related type of.
Research if they were to steel available there.
Certainly that that had an impact in the synergy trial. The fact that COVID-19 also increases the risk of patients to really acquire invasive pulmonary aspergillosis. So that's a that's an opportunity there or the current protocol.
Allowance for patients to be enrolled.
COVID-19 patients with invasive pulmonary aspergillosis that we potentially enrolling the intestinal gist study. However, we need to hear be careful because really is just we are just learning how it what is the actual natural progression and outcome of invasive pulmonary aspergillosis in COVID-19.
Afflicted subjects and that is something that we definitely need to be careful in analyzing that information. So that we can very well assess really what is the treatment effect versus what is just the underlying condition.
<unk> of these patients. So we are not the protocol allows the inclusion of these patients at the same time.
I would expect that at this point, we don't expect that is going to be the majority of the patients enrolled because physicians. The site. As you can understand this is a new a new condition or a new combination of of conditions, which is called <unk> and <unk>.
Basically pulmonary aspergillosis.
Physicians are going to be more likely to treat them with the standard of therapies, rather then enroll them into clinical trials for <unk>, specifically the treatment of <unk>.
In basic pulmonate aspergillosis, whereas they may be enrolling clinical trials for the treatment of COVID-19 that is what we have seen right now literally competing priorities that they prefer to enroll the patients into studies that are being assessing treatments for COVID-19. However, we I anticipate that we will have some cases mhm.
Right, Okay that doesn't make sense, we don't quite know effective standard of care here.
New indications and settings.
And one last one here on tiers in theory any potential for updates before Q1, when you historically provided updates.
Given the fact that there was likely an increased pace of enrollment maybe you can keep the 20 years or so.
Patients.
For theory at least and provided some information by year end or is that.
They have until the wait for for Q1.
Yes, we're always very excited to take a look at the whole debate about.
And we will do that.
And as you know the opportunity that these studies are open label allow us to really do that we have not to make a decision regarding when we will be announcing the next round of results from this particular study, but certainly where we are having discussions internally here to verify when is when is the right timing to really focus the resources of the team and.
In doing that analysis.
We will update as we as we as we made that decision.
Great and then just one final one here finally for me.
Any plans to adjust theories protocol or the execution, given the mucormycosis preclinical evidence and the synergy with the inflow inflow terrible. Thanks.
No. Thank you Michael and thank you for all those very thoughtful questions. The answer is that we don't need to amend the protocol the Fury protocol Cds right now.
<unk> is a proposal is adequately return in the way that allows for enrollment of patients with different fungal infections in including Nucor.
In the past, we would not actually advocating its use in mucormycosis patients already breaks a finger combination using immucor mycosis patients in the protocol because we just didn't have enough evidence of the potential clinical benefits now with this information coming from the preclinical data.
We have a certain need.
Addressing it with investigators that this is a potential that they can take advantage of within the Fury protocol. So the <unk> study Cds allowed the enrollment and we officially notified investigators that now this is an opportunity for them to consider the patients with nuclear mycosis to be included in the future.
Interesting very helpful. Thanks, guys I appreciate the time with all of our questions.
Thank you. Thank you. Thank you Michael Thank you Michael.
We have reached the end of the question and answer session. Dr. <unk> I would now like to turn the floor back over to you for closing comments.
Thank you very much.
First of all thank you to all my thanks to all of you have been listening to our conference.
Saying that we share the excitement of a patient and doctor for the ability of bringing finally, a new treatment for the BDC not.
Not to mention the progress in research and development in the area of hospital.
We're all of a Brexit anja for the treatment of fungal infection will become more and more relevant.
We will go to the new indication and our Phoenix, we have expertise.
There are sources to make high pressure from Genco success. Thank you very much for listening to us.
Ladies and gentlemen, this does conclude today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.