Q3 2021 Spero Therapeutics Inc Earnings Call
Okay.
Good afternoon, and welcome to this biotherapeutics third quarter 2021 financial results conference call. At this time all participants are in a listen only mode. Following the company's following remarks, we will open the poll up for questions. Please be advised that this call is being recorded and a replay will be available.
You can find information on the replay and further information related to todays announcements on these prioritize except try it at www dot sabotage predicts dot com at this time I would like to turn the call over to Dr. Jenkins, Vice President head of Investor Relations at Scioto predicts Mr. Jeong.
Please go ahead.
Thank you operator, and thank you all for participating in today's conference call.
Afternoon, Spero Therapeutics released financial results and provide a pipeline update the third quarter of 'twenty 'twenty. One our press release is available on the Investor page of its broken out because its web site.
Before we begin I'd like to remind you that some of the information contained in the news release and on this conference call contain forward looking statements based on our current expectations, including statements about potential approval of <unk> by the FDA the.
The timing of the launch after the Pan Am H B R future commercialization potential number of patients who could be treated like a impediment to be our in market demand, particularly been H. B are generally also expected broad access across payer channels protecting patent H B R. You expected pricing of <unk> and the anticipated shift in treating patients from intravenous to oral in the.
Australia.
Further the plants with the company's ongoing development of Spi 2020 statements about the future development and commercialization of <unk> and the potential receipt of milestone payments as well as royalties on potential future sales of <unk>. The design initiation timing progress and results of the company's preclinical studies and clinical trials and its research and development programs.
Managements assessment of the results of preclinical studies and clinical trial the impact of the COVID-19 pandemic on the company's business and operations and the company's cash forecast anticipates expenses.
Deficiency, if its cash resources in the availability of additional non dilutive funding from governmental agencies beyond any initial funded rewards and such forward looking statements are not a guarantee of performance and the company's actual results could differ materially from those contained in such statements.
Factors that could cause or contribute to such differences are described in detail in spero therapeutics filings with the SEC, including in the risk factors section of our quarterly report on Form 10-Q filed today.
These forward looking statements speak only as of the date of this conference call and the company undertakes no obligation to publicly update any forward looking statements or supply new information regarding the company. After the date of todays release and call.
Participating in today's call are Dr. <unk>, <unk>, Chief Executive Officer, Dr. David Melnick, Chief Medical Officer, Cristina Larkin, Chief operating Officer, and Seth Shukla, Our Chief Financial Officer.
With that I'd like to turn the call over to over to Dr. <unk>.
Please go ahead.
Thank you Chad and thanks to all for joining us today to discuss our third quarter financial results and corporate highlights.
Sparrows primary focus remains on preparing for an anticipated tenant HBO commercial launch in the second half of 2022, and I'm pleased to say that over the past months, we've achieved key milestones to advance our efforts towards this important goal.
Chief among these milestones with our recent submission of an NDA package seeking approval for turbine tenant <unk> tablets for the treatment of complicated urinary tract infections, including island nephritis caused by susceptible micro organisms.
Part of this NDA package is the positive data set from our phase III adapt Po clinical trial. These data showed that adapt piel met its primary endpoint by demonstrating with an all oral regimen of <unk> H B R was not inferior to an all IV regimen that are dependent for the treatment of complicated urinary tract infection.
Or C T I and acute pyelonephritis or AP.
Previous FDA interactions and written communications support our efforts to advance <unk> kind of H B R towards commercialization.
They indicate the positive results from a single well controlled pivotal trials, such as adapt Po could be sufficient to support the approval of an NDA for <unk>, Panama H B R. In the treatment of cdti, including Pyelonephritis.
Further through a pre NDA meeting the FDA also previously endorsed the structure in the form of a recent NDA submission. The agency indicated that the dataset and CMC plan that are now included in the package meet FDA submission standards.
Given our submission date of 27 October we anticipate that U S. D. As initial two month review during this filing period is successful the formal NDA review clock will start at the end of the year with the Paducah date six months from that point or in mid 2022.
In addition to supporting our NDA submission. Another key goal of the adapt trial was to provide physicians with the confidence needed to prescribe oral tablet that an H B R. C U T I patients, who would otherwise receive IV therapy.
We therefore designed adapt Po is the first ever head to head comparison of an all oral versus an all IV regimen and cdti. Thanks.
Thanks to this rigorous design, we believe we have achieved our goal as data show that <unk> can provide the convenience of an oral therapy without making compromises on clinical response safety or tolerability.
If approved <unk> would become the only oral cobre, Panama available for cdti patients. It has the potential to deliver value to patients health care providers and payers.
This value includes the avoidance of IV therapy reduction or elimination of hospital stays and better healthcare resource utilization overall.
We are encouraged by the response to date to the potential of <unk>. Our clinician colleagues have been supportive of the value proposition and payers have expressed their willingness to cover Panama H B R.
This bodes well for the over 2 million to UTI patients, who could benefit from an oral cobre Panama therapeutics.
In preparation for commercial launch we recently made some key hires that have added important experience and depth to our leadership team.
These hires include the addition of Jimmy Brady as our Chief Human Resources Officer, Jamie. Most recently worked in the same position that unit cure and he has over 30 years of senior human resources leadership experience within the life science space. He's been deeply involved in guiding companies to their transition to commercial organizations and we believe.
His expertise will serve us well as we continue to build our team in preparation for an anticipated <unk> launch in the second half of next year.
In addition to Jamie we further strengthened our leadership team by adding David muscle men as senior Vice President sales and market access, we believe David's talent and expertise will be invaluable to our commercial prospects.
He's worked in the pharmaceutical and biotech space for over 23 years and has experienced extensive experience in urology and in launching drugs.
Recently served as vice President of specialty sales at your event, where he was responsible for building and executing on their first product launch.
David also spent 13 years at Astellas, where he was the area Vice President responsible for leading a team of 275 sales professionals. We're thrilled to have him on board and we believe is well positioned for success in this new role.
Along with these additions to our leadership team. We also appointed Kathleen <unk> to our board of Directors. Kathleen is currently the Chief Corporate Affairs Officer at <unk> Therapeutics and previously worked in a senior capacity at Santa feet, Biogen and as a professional staff member for multiple committees in the United States Congress She is X.
Sensitive executive and pilot public policy experience as well as a deep understanding of external engagement strategies and the global payer environment.
I'd like to now provide some updates on the 720 clinical program.
As a reminder, S. P. R 720 advanced into a phase Iia clinical trial in patients with non Tuberculid might go bacterial disease.
For N P M at the end of last year.
The initiation of this trial was supported by positive data from phase, one single and multiple ascending dose trials as well as non clinical toxicology studies in nonhuman primates in rodents.
Within these studies multiple subjects in healthy volunteers were dosed.
And no severe or serious adverse events wherever observed as.
As the Phase Iia trial is being conducted however, we were also simultaneously engaged in additional longer term toxicology study in nonhuman primates.
Surprisingly and in contrast to the positive phase one.
Sad Mad human experienced unexplained nonhuman primate towards how all of these occurred this led us to pause the phase Iia clinical styling trial and promptly notify FDA of these findings. We then subsequently received a clinical hold letter in which the FDA requested additional information from the non human Primate study, including the study report.
We completed the nonhuman primate toxicology study in the third quarter.
Finally, as the study report and in line with previous guidance, we initiated engagement with FDA on the data in the fourth quarter.
As we've discussed the S. P O seven 'twenty data that we've seen to date supports the hypothesis that the observed mortality were not drug related but rather study in specie specific this gives us confidence that there is a path forward for the S. P. A 700000 clinical program. This all said the Fda's view of the data will be an important dry.
<unk> alright.
We will complete and review our interactions with FDA on the data this quarter and provide an update on the program thereafter.
I would now like to briefly highlight our non dilutive revenue interest financing agreement executed during the quarter with healthcare royalty partners worth up to $125 million. This agreement preserves our financial flexibility and further de risks have you planned on H b ours anticipated launch by providing 50 million upfront 50 million upon us.
Approval of <unk> in C O T I and 25 million upon completion of a prespecified commercial set of milestones in mutual agreement with healthcare royalty partners. Additionally.
Additionally.
We believe this agreement provides important external validation for our commercial prospects and development pipeline given healthcare royalty partners extensive due diligence process and successful track record.
In exchange for their investment healthcare royalty partners will receive a tiered royalty on applicable revenue generated by Sparrow. This royalty will begin in the low double digits decrease to the low single digits. Upon completion of certain annual revenue thresholds and phase out completely once the aggregate amount paid to healthcare royalty partners is two five times the total investment amount funded.
We believe these are favorable transaction terms that will preserve our financial flexibility and upside as we move towards <unk> anticipated launch and work to advance SPR 720 N S. P O to O six through clinical development.
Lastly, before I hand, it off to David I'd like to recognize the hard work of our employees, our partners and our investigators which allowed us to have a successful quarter amongst the ever evolving circumstances of the COVID-19 pandemic.
Thanks to their efforts, we have not seen any material impacts from the pandemic this year.
The pandemic has done however is highlight the value of replacing IV therapies that are often administered in the hospital setting with an at home oral option, we believe that turbine Pelham H B R. If approved could provide such adoption and enable a shifting care to the outpatient setting this would provide value to patients health care providers and pay.
Here's alike as it would reduce patient exposure to COVID-19, and other secondary infections hospitals would also see a financial benefit and free up capacity for the seriously ill patients with no viable alternatives the hospitalization.
I'll now hand, it over to David to provide a more detailed update on our clinical progress.
And our pipeline.
Yeah.
Thank you want kit.
It's my pleasure.
My point updates today.
I'd like to start.
I'd like to start by first thanking all of those.
Yeah.
Excuse me.
I'd like to start by first thanking all those who made the recent tepid kind of H B R. M. D. H piling possible with strong emphasis on the patients who participated in our clinical trials. This is a land market.
Treatment for Spero, and we look forward to working closely with the FDA throughout the review process.
Alongside of our regulatory efforts. We also continue to work with external partners to ramp up our CMC capabilities ahead of Tami tenants expected launch in the second half of 2022 <unk>.
These partners, notably include major sector, whose experienced manufacturing and oral granular formulation that can be kind of over the last decade will be invaluable as we move forward toward commercialization.
We are also continuing our work to educate the clinical community on the utility of Tami tenants H B R and the potential benefits it could provide to health care providers payers and patients are peer reviewed manuscript reporting the adapt trial results has been provisionally accepted and we.
Publication in the first quarter of 2022.
We're also attended I D weeks.
<unk> conference in late September with 23 poster presentations showcasing in vitro and in vivo studies that have been kind of H B R and highlighting the additional research on the epidemiology and management of complicated urinary tract infections.
Beyond C U T I adapt PFS data have also generated strong external interests from the medical community on the use of <unk> 10 of H b or to treat other infections. For example have been kind of H B R is being evaluated in the Marina for trial, which is being conducted by the antibacterial resistance.
Peter ship group and is sponsored by the National Institute of allergy and infectious diseases. As a reminder, this trial is designed to compare really transition to oral therapy to have them with continued intravenous carbo kind of therapy in patients with blood stream infections caused by ESPN positive bacteremia.
Bacteria, we anticipate that patients will start dosing in this study during 2022.
We have also successfully completed the BARDA funded phase one bronchial alveolar lavage trial.
I think the lung penetration of <unk> 10 of H B R and we anticipate presenting these data at an upcoming medical meeting. These studies are part of a broader umbrella building partnerships with our clinical colleagues as part of this our medical affairs team has interacted with over 500 infectious disease.
Physicians and urologists.
Date.
Shifting gears I will now speak briefly on SPR seven 'twenty, our oral drug candidate in development for the treatment of MTM infections. Since <unk> already spoke about the events that led to the program's clinical whole I'll just emphasize a few additional points now rather than repeating what you just went over.
First we absorbed the observed mortality in the non human Primate study that led to the whole did not correlate with the dose where was the duration of SPR 720 drug exposure.
Further adult nonhuman primates are known to be very challenging to dose, which adds a level of complexity to the analysis.
Finally, the findings from this non human Primate study are contrary to what we have seen in prior preclinical and clinical studies of SPR 720.
While we arent going to disclose the specific findings from the non human Primate study until the FDA has given us their written feedback on the data I will once again emphasize that based on all of the results. We've seen to date, we remain confident that there is a path forward.
<unk> 720 clinical program.
These data continue to support the hypothesis that the observed mortality were not related to an off target pharmacologic effect, but rather where specific either to the oral gavage dosing method and.
I will again reiterate a point I've made.
Several times in the past which is better.
Its decision.
Oh Wow.
No.
<unk> of our opinion regarding the ultimate success of the SPR seven two program.
Rather it was a strategic decision.
Yes.
[noise] walnuts.
And that may facilitate potential future adjustments to the phase II clinical trial design.
Looking ahead, we recently completed the full study report as requested by the FDA when our FDA interactions and our internal review were complete we will provide the market with an update on the SPR 720 program.
I'll now move on to discuss S pure to our six our intravenously administered next generation polymyxin product candidate S.
S. P O to O six is designed to directly on the Gram negative bacterial infections.
Its interactions with the bacterial outer membrane.
<unk> has demonstrated potent broad spectrum activity against Gram negative bacteria, including extensively drug resistant variants.
Through two O SPR <unk> clinical development, we hope to provide patients suffering from serious drug resistant infections, such as drug resistant acinetobacter drug resistant Pseudomonas and <unk> 10 of mace, producing inter bacteriology with a safer alternative compared to the current standard of care.
Today patients with these infections are prescribed a drug combination that generally includes a carpet tandem or beta lactam beta lactam <unk> inhibitor antibiotics, along with polymyxin b or calista. Despite these older polymyxin as being associated with considerable referenced toxicity in any pain.
<unk>.
In contrast data from a phase one trial of <unk> six show a lack of effort toxicity at or above the predicted therapeutic dose. This clearly differentiates SPR <unk> compared to <unk> and other polymyxin antibiotics.
Supports the hypothesis that S. P. R. Two of six could replace calista in the currently prescribed regimens and provide an alternative option for patients with significantly reduced risk of kidney injury. This would address a crucial unmet need as the cdc's antibiotic resistance.
Threats report estimates 8500.
Drug resistant acinetobacter cases, and 32600 drug resistant pseudomonas infections in the United States each year.
Looking ahead, we continue to advance Spr's two O six clinical development with the support of several highly regarded partners, including Pfizer Everest medicines, the department of defense and the National Institute of allergy and infectious diseases, we have completed dosing.
In our phase one bronchoalveolar lavage clinical study, which assesses the penetration of SPR to six into the pulmonary compartment.
And which remains on track for release data in early 2022.
Given that many of our target patients for SPR to six suffer from lung infections. We believe that these data could represent a key inflection point for this program in parallel our ongoing phase one renal impairment study of <unk> is also progressing as planned data from this study.
We'll guide dosing in the many patients with multi drug resistant infections that have reduced kidney function.
Also expected by early 2022.
With that I will now turn the call over to our Chief operating Officer, Cristina Larkin, who will provide you with a review of the market opportunity for our pipeline products and detail our strategy for the launch of <unk>.
Thank you David and good afternoon, everyone as we move closer to a tech tenant hcr's potential commercialization, we continue to focus on being launch ready, including building out our launch team.
<unk> mentioned, we recently hired David muscle and SVP of sales and market access David has experience in building sales pacing team has been through multiple launches and has extensive experience in the urology space.
David any other commercial leaders are focused on three pillars that will launch readiness, which increased our sales force deployment, our market access strategy and execution and our branded and unbranded HCP marketing campaign.
In fact, we've already deployed our disease awareness campaign, which is our first initiative in our digital first plan and that this increase in unbranded web site, which is C. UTI evolution dot com.
The site is an important tool to educate healthcare providers on the burden of Etsy Ti and the resistance trends to currently available oral treatment options for cdti.
Now as we look ahead, we continue to pair to prepare for a specialty driven launch focused on urologist and infectious disease physicians now this strategy will allow us to capture a significant portion of the approximately $2 million PCI patients in the U S that we believe are appropriate appropriate for the treatment of <unk> HDR if approved.
There's a substantial opportunity in both the community and the hospital discharge market to convey a clear and compelling story, because heavy pediments potential clinical and economic benefits now in the community setting <unk> could potentially keep patients who have failed previous oral antibiotics or who are resistant to current oral <unk>.
ATI therapy out of the hospital.
And then the hospital discharge setting can be pay them could give healthcare providers the ability to discharge CCI patients sooner highlighting the clinical and economic advantages switching to oral therapy.
Now the impact of CPI and either setting can have a meaningful impact for both the patient and their family.
Now this was highlighted recently when it was reported that former President Bill Clinton was hospitalized with the complication associated with a urinary tract infection now President Curtis experience. Highlights example, the millions of patients that are impacted by cdti annually and the important role antibiotics can play in helping patients get back home and back to their fab.
Please.
And this has become especially important in a COVID-19 environment, we're avoiding the hospital or getting them sooner from the hospital is a priority for everyone at <unk>.
Especially at the patient.
This is why we continue to be so excited about <unk> potential to keep patients out of the hospital or get them home sooner and.
It has a tremendous opportunity to deliver value to all of our relevant stakeholders, including health care providers payers and most importantly, our patients.
We believe we are poised for an exciting time ahead and look forward to continuing our efforts to plan for Kirby opinions much anticipated potential approval in.
And the commercial launch now with that I'll turn the call over to SaaS will provide you with a financial update.
Thank you Christina and good afternoon, everyone.
I'd now like to turn your attention to our overview of financial results for the quarter ended September 32021.
Total revenues for the third quarter of 2021 were $3 1 million compared with revenues of $4 million in detail the departure of 2020.
The revenue decrease was primarily due to a decrease in qualified expenses incurred.
Thank you Eddie bogged out contracts like <unk>, partially offset by an increase in funding under our <unk> agreement relating to Spi two things.
Research and development expenses, but he third quarter of 2021 $14 $4 million.
Compared to $17 7 million for the same period in 2020.
This year over year decrease was primarily due to the completion of significant activity in the phase III clinical trial.
And on HBO and decreased spending associated with the clinical hold on the phase two.
Clinical trial for <unk>.
Spi 2000, Twenty's offset partially by increased clinical study costs for Spi, two states and an increase in personnel costs associated with additional research and development headcount.
As we have stated earlier in the year, we expect our full year R&D expenses in 2020, you wanted to be consistent relative to 2020.
I will note that we expect fourth quarter R&D expenses to be more like a first quadrant as opposed to the lower spend in Q2 and Q3.
The ramp of CMC activities and the implementation of our medical affair strategy to support a potential launch of Epipen and <unk> in 2022.
General and administrative expenses, but he put quarter of 2020, one of $11 2 million.
Then the $5 3 million reported for the same period in 2020.
I'm really due to an increase in head count in our commercial general and administrative functions as well as an increase in professional and consulting fees to support potential commercialization of Chevy bolt on HBO.
Consistent with prior quarters. This year, we expect G&A expenses to continue to increase in the fourth quarter as the build commercial capabilities and the infrastructure.
Support the expansion of I hate to have a potential to have you been a <unk> commercial launch in 2022.
We reported a net loss for the third quarter ended September 32021 of $22 5 million.
Our <unk> 17 per common share.
Compared to a net loss of $18 9 million or <unk> <unk> per common share reported for the same period in 2013.
With a D S M C. Today.
He would now like to open the call up a question.
Alright, you too.
[noise] <unk> [noise].
Ladies and gentlemen, if you would like to ask a question. Please take note by pressing star one on the telephone keypad, if you're using a speaker phone. Please make sure. Your mute function is sent off to lawyers take no tomato equipment.
Will now take our first question.
From Richard morale of colon. The line has happened. Please go ahead.
Good afternoon.
Hi, Thanks for taking the question I have two two important ones then I'll hop back into cute.
One can you give us a little more detail on the C. M. P inspection status the the Japanese plant that will be the primary source of commercial material is that currently G. N P certified in and recently expected or do you anticipate some.
<unk> some flexibility surrounding inspections, just given the pandemic and then I have a question on current.
Resistant right.
Go ahead ask it later [laughter].
Yeah sounds great. Thanks for the question I redo yeah. So we've been Ah we've been building the CMC supply chain with our partner made you say go for it for several years and as a reminder, made you say guy has been producing tubby pet H B R for its own uses for commercial sale for nearly a decade.
Unknown Executive: Nearly a decade. And so we have a lot of confidence in the standards at which that plant has developed. And as we step back and think about, you know, the impact of the pandemic, the FDA put out a publication earlier this year noting that a very small minority, I think, you know, 60 percent or so out of many thousands of applications were impacted by inspection-related delays during the heart of the pandemic.
And so we have a lot of confidence in the standards in which that plant is develop and as we step back and think about you know the the the you know the impact of a pandemic F. D. I put out a publication earlier this year, noting that a very small minority I I think you know 60 summer show out of many thousands of Apple.
Locations were impacted by inspection related delays during the heart of the pandemic. They then followed up with a publication talking about their ability to use data requests video review in other ways to complement their ability to have them person inspections, which we do know they have resumed overseas as well. So we have a lot of confidence in major they've been menu.
Unknown Executive: They then followed up with a publication talking about their ability to use data requests, video review, and other ways to complement their ability to have in-person inspections, which we do know they have resumed overseas as well. So we have a lot of confidence in Meiji. They've been manufacturing to a high standard for many years, and we believe that as the pandemic has moved on, the FDA has also used all the tools available to be able to navigate the inspection work ahead of them.
Factoring to a high standard for many years and we believe that as the pandemic has moved on the F. D. A is also used all the tools available to be able to navigate the inspection work ahead of them.
Unknown Attendee: Got it. And then, I guess, resistance rates, especially for corn, resistance rates, can you talk about where those stand currently? Have they been affected at all by, you know, pandemic restrictions or hospital policy, processes, et cetera, you know, has the pandemic impacted those rates for better or worse at all?
Got it and then I.
I guess.
Resistance like especially dark on existence right resistance right can you talk about where the band currently fluffy have they affected at all by hand.
Pandemic restrictions or or hospital.
Hospital policies processes et cetera, you know.
<unk> has the pandemic and package right now.
That'll work at all.
Unknown Executive: Thanks for the question. Resistance rates to fluoroquinolones are something we've tracked for some years, both using external sources like JMI but also our own surveillance efforts through a program called Steward. And what we've noticed is that those resistance rates have continued to increase year over year, and that's continued unabated relative to the pandemic. And so, you know, kind of the same fundamentals where we've seen a lot of floor quinoleum usage currently in years past, leading to resistance that's now being exchanged amongst those bacteria. And the pandemic has certainly made the case that we should be treating more patients outside of the hospital. But it hasn't impacted the fundamental microbiological problem that's causing all of this. And that continues to increase. Great.
Thanks for the question you know, it's the the resistance rates to floor quinolone for something we've track for some years, both using external sources like jam I, but also our own surveillance efforts to a program called steward and what we've noticed is that those resistance rates have continued to increase.
You're over here and that's continued unabated relative to the pandemic and so you know kind of the same fundamentals, where we've seen a lot of floor quinolone usage currently in years past leading to resistance. That's now being exchanged amongst those bacteria continues and the pandemic has certainly made the case that we shall.
Be treating more patients outside of the hospital it hasn't impacted the fundamental microbiological problem, that's causing all of this and that continues to increase.
Unknown Attendee: Great. Thanks so much. I'll hop back in the queue.
Great. Thanks, so much I'll hop back in the queue.
Operator: Thank you. We'll now take our next question from Lewis. Your line is open. Please go ahead.
Hi came out and I'll take her next question families Atlantis happen. Please go ahead.
Lewis: Hi, thanks for taking my questions here. So the first question I had for you is how you're thinking about manufacturing for Teb Pennam here. Can you give us the latest update, and how much product will you have at launch? And then, in terms of the market opportunity for SPR 2X6, can you elaborate?
Hi, Thanks for taking my questions here. So the first question I have for you is how old you are thinking about manufacturing for to have U. Penn I'm here can you give us the latest update and how much product will you have at lunch and then in terms of the market opportunity for S. P. R. Two X six can you elaborate more on that.
Lewis: Hi, thanks for taking my questions here. The first question I had for you is how you're thinking about manufacturing for Teb Pennam here. Can you give us the latest update and how much product you will have at launch? And then, in terms of the market opportunity for SPR 2X6, can you elaborate more on that and what you think the peak sales potential could be for that product?
And what you think the peak sales potential could be for that product. Thank you.
[noise].
At least I think we're having some.
Technical difficulties do you mind restating the question.
Yeah sure. Okay. So <unk> you know my questions for you were first of all can you give us an update on the manufacturing for tevye pattern and how much product you're gonna have at lunch and then what is the market opportunity for the S. P. R. Two O six product and how should we think about peak sales potential here.
Operator: Thank you. Thank you. Louisa, I think we're having some technical difficulties.
Operator: Do you mind restating the question? Yeah, sure. Okay.
Lewis: So, you know, my questions for you were, first of all, can you give us an update on the manufacturing for Tebepenum and how much product you're going to have at launch? And then what is the market opportunity for the SPR 206 product? And how should we think about peak sales potential here?
Yeah. Thanks for the question can you hear me now.
Yes.
Great. Okay. So the manufacturing as we had mentioned the.
Unknown Executive: Yeah, thanks for the question. Can you hear me now?
Unknown Executive: Yes. Great. Okay.
We've been working with major Saker, our partners since we began developing tubby pet him made you saker has been manufacturing tubby pet him for commercial sale for nearly a decade and in partnership with them. We have our supply chain set up with them and we're confident in their abilities moving forward in their ability to manufacture tubby pet them.
Unknown Executive: So the manufacturing, as we mentioned, we have been working with Meiji Seca, our partner, since we began developing Tebipenum. Meiji Seca has been manufacturing Tebepenum for commercial sale for nearly ten years. And in partnership with them, we have our supply chain set up with them, and we're confident in their abilities moving forward and their ability to manufacture Tebepi Penham at a high scale. In terms of how much product we'll have on hand, it's certainly our intention to have, you know, sufficient product in excess of what we're thinking about for our launch trajectory.
To continue manufacturing tubby pet them at a high scale.
In terms of how much product will have on hand, it's certainly our intention to have you know sufficient product in excess of what we're thinking about for a launch trajectory and as we get closer to launch will be guiding in further detail about what those expectations are and as it relates to the final question about the market opportunity for two O. Six we are excited about the pro.
Unknown Executive: And as we get closer to launch, we'll be guiding you in further detail about what those expectations are. And as it relates to the final question about the market opportunity for 206, we are excited about the program. And I'll pass it over to Christina to comment further about the potential we see in the program. Thanks, Anken, and you know, we haven't really
Graham and I'll I'll I'll pass it over to Christina to comment further about the potential we see in the program.
Okay, and you know, we've not really guided to let those pique your sales numbers and you know look like but I think it's David highlighted what you see is an important contribution to these you know highly resistant strains that we see in the hospital setting for Acinetobacter state amount S N E.
Christina: Thanks, Anken, and you know, we're not really guided to what those peak year sales members look like. But I think, as David highlighted, what you see is an important contribution to these, you know, highly resistant strains that we see in the hospital setting for Acinatobacter, pseudomonas, and even those carbapidem resistant bacteria in our ACA. And as you look across that spectrum of, you know, both what the CDC reports and also, you know, looking at, you know, other reports.
The amount of this carpet penumbra assistant in our back to ICA and if you look across that that spectrum of you know both what the C. D. C reports, but also you know looking at you know other reported data through other hospital related infection data, you'll see that this is you know a quite broad opportunity I think it's important to put in.
Christina: Through other hospital-related infection data, you'll see that this is, you know, a quite broad opportunity. I think it's important to put into perspective that we continue, much like we see the growing resistance of what we're seeing around the community setting, resistance in the hospital continues to grow as well. So we see it as a great opportunity. We're not really guided to any peak year or sales numbers as yet for 206.
Ted perspective that we continue much like we see that growing resistance of of what we're seeing around the community setting is resistance in the hospital continues to grow as well. So we see it as a great opportunity with not really got into any pickier or our sales numbers as of yet for two that sex.
Operator: Thank you. We'll now take our next question from Ram of H3 rain white. Your line is open, please go ahead.
Thank you.
Thank you and I'll take her next question from Ram of <unk> Lane White, you line has had a pen face color height.
rahm: Thank you so much for taking my questions. Firstly, on the commercial front with Tebipanem, can you give us some additional color on how you're seeing the overall market access picture evolving in the context of the potential launch? And in particular, if you've seen any notable evolution in your thinking, in the overall environment that you anticipate from the perspective of gross to nets, thank you. Thanks, Rahm, for the question. Christina, I'll hand that to you to cover for Ron.
Thank you so much for taking my questions. Firstly on the commercial front with that'd be fun can you give us some additional color on how you're seeing the overall market access picture evolving in the context of the potential launch and in particular, if you seen any.
Notable evolution and you're thinking in the overall environment that you anticipate from the perspective of gross to next thank you.
Thanks, Rob for the question Christine I'll have that to you to cover for them.
Christina: Great, thanks, Ron, for the question. We've actually done quite a bit of market access work to date, speaking both on the payer side and also through some fairly extensive market research. I think a couple important findings is that we're getting a really great reception from our payers. They do see the value, the ability to prevent a hospitalization, or in many cases, those patients who are currently in the walls of the hospital are often being sent to post-acute care centers or home infusion, and all of those are obviously very costly things for the payer.
Great. Thanks for the question, we've actually done quite a bit of market access work today as speaking both on the payer side and off it through some fairly extensive market research I think a couple of important findings is that we're getting a really great reception on the behalf of our payers. They do see the value the ability to prevent the hospital or.
Nation or in many turns his patients who are currently in awhile for the hospital are often being sent to post acute care centers or home infusion and all of those are obviously very costly you know things for the terror and so they do see the value I think that's an important part of it you know we have sort of Guy. This is the fact that we do.
Christina: And so they do see the value. I think that's an important part of it. You know, we've sort of gotten used to the fact that we do think that we will get broad coverage around the compound. We've heard, you know, very positive feedback so far from our payers because of that value story and the trial that we conducted, which was against an IV, which I think is a really important part of, you know, what we've been sharing.
You think that they are we will get broad coverage around the compound. We've heard you know very positive feedback so far from our payers because of that value story and the trial that we conducted which was against <unk>, which I think is a really important part of of.
What we've been sharing I think the second part is you asked about question that we've not guided to what that looks like what I would say is that it may go back to as you look at the payer mix in general as you think about that and I think as we stated in previous calls too that we feed the payer mixed being about 50 50 split between both government and.
Christina: I think the second part is you asked about gross to net. We're not guided as to what that looks like. What I would say is that it may go back to as you look at the payer mix in general as you think about that. And I think, as we've stated in previous calls, too, that we see the payer mix being about a 50-50 split between both government and commercial pay. That's, you know, the best I could guide you right now on growth to that. No, that's helpful.
And commercial pay.
But that's that's you know the best I could guide you right now [laughter] onwards to that no. That's that's helpful. Also as as as an adjunct to that I was wondering if you can provide us with any additional information regarding the commercialization of taboo kind of in Japan by major saker and if that.
rahm: Also, as an adjunct to that, I was wondering if you can provide us with any additional information regarding the commercialization of Teditem in Japan by Meiji Seika and if that has any new read-through for you folks as you look towards the potential launch in the U.S. Yeah, Rom, thanks for the question. Just as a reminder, Tebipenum is marketed in Japan for pediatric respiratory infections. It's a decision they've made based on the resistance environment that exists in Japan today and the existence in their own portfolio of another CUTI medication.
Has any new read through for you folks as you look towards the potential launch in the U S.
Your thanks for the question just as a reminder, tubby Pan am is marketed in Japan for pediatric respiratory infections. It's it's a decision they've made based on the resistance environment that exists in Japan today, and the existence in their own portfolio of another C. U T. I medication you know sofa.
rahm: So for those reasons, over the years, Tebipanum is an important part of Meiji's portfolio, but we don't see much read-through to the adult CUTI market in the years. U.S. just given the different indications that they're going out.
Always reasons over the years <unk> is an important part of majors portfolio, but we don't see much read through to the adult C. U T I market in the U S. Just given the different indications that they're going after.
rahm: Okay, and then lastly, with respect to 720, I was just wondering if you now have kind of an updated timeline with which you anticipate the drug might return to active clinical development, and if you could just walk us again through what the gating items might be there. Thank you.
Okay, and then lastly, with respect to 720 I was just wondering if you know have kind of an update a timeline with which you anticipate you know the drug Mike returned to active clinical development and if you could just walk us again through what the gating items might be there. Thank you.
Yeah, Ron Thanks for that question as well you know as we mentioned on the call you know the the first step was completing the talk study, which we did in the third quarter. The second step which were in the middle of now has been engaging F D. A in a submission and <unk>.
Unknown Executive: Yeah, Ron, thanks for that question as well. As we mentioned on the call, the first step was completing the talk study, which we did in the third quarter. The second step, which we're in the middle of now, has been engaging FDA in the submission and discussion of the data, having a discussion with them, receiving their written comments, and then reviewing them to apply them to what future protocol we may institute.
<unk> of the data, having a discussion with them receiving the written comments and then reviewing them to apply them to what future protocol, We May Institute with their feedback. So we're in the middle of all that right now and as we go through that we will have an update for you and after that we'll have more granularity.
Unknown Executive: with their feedback. So we're in the middle of all that right now, and as we go through that, we will have an update for you. And after that, we'll have more granularity to share about the timing of when we might be able to get back online.
To share about the timing of when we might be able to get back online.
Operator: Thank you. We'll now take our next question from Lester of Barenbeck. Your line is open, please go ahead.
Thank you.
<unk> will now take our next question from Master of Bang Bang you Ladies had been please go ahead.
Lester: Hi, thanks for taking my questions and congratulations on the submission of the NPA. Just wanted to ask about SPR 206, the BAL study. Wanted to get your expectations and then additional details on what those results might mean for the next step. Thanks. Yeah, thanks for the question on 206 S.
Hi, Thanks for taking my questions and congratulations on information in the N E a.
Just wanted to ask on S. P. R 206 to be a I'll study wanted to get your expectations and then uhm additional detailed on what those results might mean for next day. Thanks.
Yeah. Thanks for the question on on two O. Six Esther we were also excited about that as we I was 720th <unk>. The important part of the balance study is that it helps us understand how chubby or how two O six gets into a lung tissue and as David mentioned why that's important.
Esther: Yeah, thanks for the question on 206, Esther. We're also excited about that, just as we are with 720 and Tebip Penham.
Unknown Executive: The important part of the bowel study is that it helps us understand how 206 gets into lung tissue. And as David mentioned, why that's important is because we have many patients that we're trying to help with 206 who happen to have lung infections. Or in other words, those pathogens that 206 is best suited to often end up in patients' lungs. And so the idea of being able to show that 206 can get into the lungs in the right concentrations is an important inflection point for 206. And so what to expect is that we'll be looking at lung penetration and will be making a determination of how that can impact the outcome of patients with lung infections.
Is because we have many patients that we're trying to help with two O six that happened to have lung infections or in other words those pathogens at two O. Six is best suited too often end up in patients lungs, and so the idea of being able to show the two O six can get into lungs in the right concentration is an important inflection point.
Four two O six and so what to expect is is that it'll be you know there will be looking at the long penetration and we'll be making a determination of how that can impact the outcome of patience with with lung infections.
Operator: Thank you. Once again, ladies and gentlemen, if you would like to ask a question, please press Star 1 on the telephone keypad. We'll move on to our next question from Bird of BG. Your line is open. Please go ahead.
Alright, thank you.
Thank you once again, ladies and gentlemen, if you would like to ask a question. Please press one on your telephone keypad Bill move onto the next question from that of B T. I J. Your line is open. Please go ahead.
Bird: Yes, thank you for taking the question, and I greatly appreciate it. With regard to UTI, you obviously have your, excuse me, you obviously have your hands full with Debbie Penham with regard to complicated UTI. But as you think about additional indications beyond complicated UTI, could you give us a sense of the timetable for your consideration and your promotion of those indications? Thanks so much.
Yes. Thank you for taking the question I agree. We appreciate it with regard you. Obviously you have your your excuse me you. Obviously you have your hands full with have you pediment with regard to complicated U T I.
As you think about additional indications beyond complicated you too I could you give us a sense of a timetable for your consideration your prosecution of those indications. Thanks so much.
Unknown Executive: Yeah, thanks so much for the question. We absolutely note the utility of Tebipenum outside of CUTI. Just as an example, we went head to head against Erdipenum, and there are many uses of Erdipenum outside of CUTI. And so what we are doing now, as David mentioned on the call, is we're taking a stepwise approach to exploring that. We mentioned that we completed the dosing of our Bronco-Eleol-Lavage study. That's the first step to seeing what Tebipenum can do to help patients. with lung infections
Yeah. Thanks, so much for the question, we we we absolutely no the utility of Tubby pet them outside of C. U T. I just as an example, yeah. We went head to head against <unk> and there are all many uses of <unk> outside of C. U T I and so what we're doing now.
As David had mentioned on the call was we're taking a step wise approach to exploring that we had mentioned that we've completed dosing of our Bronchoalveolar Lavage study. That's the first step to seeing what type of pet him can do to help patients with lung infections. You know as another example is looking at what type of pet him can do and blood stream <unk>.
Unknown Executive: You know, another example is looking at what Tebipenum can do in bloodstream infections, as David mentioned in our work with ARLG. We're also taking a stepwise approach to other indications. For example, you know, we'll be exploring the skin, the effect of Tebipenum, and its penetration into skin and soft tissue, which is a precursor to how we think about Tebipenum's utility in mixed wound infections like diabetes and foot infections. And then finally, you know, in looking to partner with our colleagues in urology, we've been looking at the impact of Tebepenum in prostititis, as an example, and how Tebepenum can penetrate prostate tissues as a first step toward that indication.
Uhm infections as David had mentioned with our work with a R. L. G.
We're also taking a step wise approach to other indications. For example, you know will we will be exploring the the the the skin the effective tabby pena minutes penetration of the skin and soft tissue, which is a precursor to how we think about that'd be penans utility in mixed wound infections like diabetic foot infections.
And then finally, you know out of looking to partner with our colleagues in urology, we've been looking at the impact of Tubby pet him in Prostatitis as an example, and how to have your pin them can penetrate prostate tissues as a first step towards that prostatitis indication so putting that all together, we're taking the first step in terms of explore.
Unknown Executive: So putting that all together, we're taking the first step in terms of exploring how Tebepenum can get into tissues that drive relevant infections. And the second step, in partnership with our clinicians and colleagues, is to then prioritize those and think about future indication-based studies.
Boring, how tubby pet him can get into tissues that drive relevant infections and the second step in partnership with a clinician colleagues is to then prioritise those and think about future indication based studies.
Unknown Attendee: Thank you for that. I look forward to the additional work.
Thank you for that look forward to the additional work.
Operator: Thank you. We'll now take our next question again from Rita of Cohen. Your line is open. Please go ahead.
<unk> take her next question again, some <unk> of Kevin Eli and he said it then please go ahead.
Rita: You guys mentioned a few of the additional, I guess, phase 3D studies that you're conducting and presenting at medical meetings. Maybe you could give us more color on which ones are either the Sparrow-sponsored ones or maybe investigators' sponsored heavy-pendum studies. Do you think which might be most useful for the commercial effort? Yeah, you know, which ones and when might we see them?
You guys mentioned a few of the additional against Phase three studies that you're conducting in presenting at medical meetings.
Maybe you could give us more color on which is either the spirit sponsored ones are medium ice skaters sponsored study do you think might be most useful for the commercial work.
Yeah, you know, which ones and when might we see them.
Unknown Executive: Yeah, Rithu, thanks for the question. I think it's a great opportunity to build off of the prior question. We think that all of those use cases, so for example, lung infections for Tabipetam, as explained by the BAL study, wound infections, as we'll start to explore with the skin and soft tissue decay study, and prostate infections that our urologist suggested as we'll look through the prostate penetration study, are all good examples. of commercially relevant applications where there are patients that we can help outside of Tempem.
Thanks.
Yeah <unk>. Thanks for the question you know I think it's it's it's a a a great opportunity to build up with the prior question. We think that all of those use cases. So for example, lung infections for for Tubby pet him as is explained by the B a L study wound infections as.
You know, we'll start to explore with the skin and soft tissue P. K study prostate infections that our urologist suggested as will look through the prostate penetration study are all good examples of commercially relevant applications, where there are patients that we can help outside of <unk>. The other important one that we note is.
Unknown Executive: The other important one that we note is bacteremia, which will be explored by our colleagues and partners at ARLG. In terms of timing, David mentioned kind of the first bolus of data, which is around the BAL study, and our intention with all of these studies will be to use the cadence of medical meetings, whether that's ID meetings or urology meetings, to begin to showcase that data. And so as these studies complete, as we did with the BAL study, we will communicate their completion. And as the right medical meetings come up, we will be putting that into the literature to help our colleagues that are beginning to learn how to best use TEPI Pennum.
Uhm, bacteremia, which will be explored by our colleagues and partners at a O L. G. In terms of timing David mentioned, the first bullis of of of data, which is around the B a L study and our intention with all of these studies will be to use the cadence of medical meetings upcoming whether that's I D meetings.
Or urology meetings to begin to showcase that data and so as the study's complete as we did with a b I L study, we will communicate their completion and has the right medical meetings come up we will be putting that into the literature to help our colleagues that are beginning to learn how to best use that'd be kind of.
Rithu: Got it. Thanks for taking the follow up.
Got it thanks for taking the follow up.
Operator: Once again, ladies and gentlemen, if you would like to ask a question, please press Star 1 on your telephone keypad. Thank you. It appears there are no further questions at this time. I'm handing it back over to you for any additional closing remarks. Thank you.
Once again, ladies and gentlemen, if you would like to ask a question. Please press star one on your telephone K Pat Thank K.
It appears that no further questions at this time.
I'm handing it back over to you so any additional of closing remarks.
[noise]. Thank you operator, and I appreciate everyone's time for joining us today, it's been a very productive quarter and we look forward to the continued advancement of our pipeline will keep everyone adopted along the way thanks very much.
Unknown Executive: Thank you, operator, and I appreciate everyone's time for joining us today. It's been a very productive quarter, and we look forward to the continued advancement of our pipeline. We'll keep everyone abducted along the way. Thanks very much.
Operator: Thank you all. Ladies and gentlemen, this concludes today's call. Thank you for your participation. Stay safe. You may now disconnect.
Thank you ladies and gentlemen, this gunplay, it's today's call. Thank you for your participation stay safe you may now disconnect.
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