Q2 2020 Spero Therapeutics Inc Earnings Call
[music].
Operator: Greetings and welcome to the Spero Therapeutics Second Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Sharon Clary. Thank you. You may
Greetings and welcome to the special Therapeutics second quarter 2020, <unk> earnings Conference call. At this time all participants are in a listen only mode. A question answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad as a reminder.
This conference is being recorded it is now my pleasure to introduce your host Sharon clarity. Thank you may begin.
Sharon Clary: Great. Thank you, Operator, and thank you all for participating in today's conference call. Earlier today, Spero Therapeutics released financial results and provided a pipeline update for the second quarter ended June 30, 2020. If you have not yet seen the press release, it's available on the investor page of the Spero Therapeutics website. Before we begin, I'd like to remind you that some of the information contained in the news release and on this conference call contains forward-looking statements based on our current expectations. Such forward-looking statements are not a guarantee of performance, and the company's actual results may differ materially from those contained in such statements. Several factors that could cause or contribute to such differences are described in detail in Spero Therapeutics' filing with the SEC. These forward-looking statements speak only as of the date of this press release and 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 today's release and call.
Great. Thank you operator, and thank you off the participating in todays conference call.
Earlier today for therapy, that's released financial though.
Provided a pipeline update for the second quarter ended June Thirtyth 2020.
You have not yet seen freshly that's available on the investor page of to scare Therapeutics website.
Before we begin I'd like to remind you that some of the information contained in the news release and on the conference call contain forward looking statements are based on current expectation.
Such forward looking statements or not I guarantee you Cook woman and the company's actual results.
May differ materially for those contained in such statements.
Factors that could cause or contribute to separate jets are described in detail is fear therapeutics filing with the FTC.
These forward looking statements speak only as of the data the press releasing 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 today's release in call.
Sharon Clary: Participating in today's call from Spero are Dr. Ankit Mahadevia, Chief Executive Officer, Dr. David Melnick, Chief Medical Officer, Christina Larkin, Chief Operating Officer, and Steve DiPalma, Interim Chief Financial Officer. With that, I'd like to go ahead and turn the call over to Dr. Ankit Mahadevia. Please go ahead, Ankit.
Participating in today's call from Spiro.
Dr and keep my opinion, Chief Executive Officer, Dr., David No, Nick Chief Medical Officer, Kristina Larkin, Chief operating Officer, and Steve Dipalma interim Chief Financial Officer.
Now I'd like to go ahead and turn the call over to data <unk> Inc. Please.
Please go ahead.
Thank you Karen and good afternoon, everyone. We appreciate you joining us today.
Ankit Mahadevia: Thank you, Sharon, and good afternoon, everyone. We appreciate you joining us today.
Ankit Mahadevia: Spero continues to make significant progress in advancing its pipeline. We're pleased to announce that we remain on track to report top-line data from our phase three trial for tebipenem HBR in complicated urinary tract infections called ADAPTO in the third quarter. The ADAPTO trial is a head-to-head evaluation of oral tebipenem versus IV ertepenem, and it's designed to give physicians the confidence to prescribe tebipenem HBR based on robust evidence of its positive effect on patients. In the second quarter, we were happy to complete patient enrollment and follow-up in the trial, which remains blinded at this point. If successful, the trial, together with supporting phase one trials that we are completing, will enable us to file for regulatory approval of tebupenem HVR for CUTI in the U.S., which, if approved, will facilitate our evolution to a commercial stage company.
That's fair continues to make significant progress in advancing its pipeline. We're pleased to announce that remain on track to report topline data from all phase three trials would tell dependent hbr uncomplicated urinary tract infections called the appeal in the third quarter. The adept field trial is a head to head evaluation of oral heavy pent up.
Versus I'd or dependent and it's designed to give position, but confidence to prescribed have you kind of hbr based on robust evidence of positive patient outcomes.
In the second quarter, we were happy to complete patient enrollment in follow up in trial, which remain blinded at this point.
If successful the trial together, what's supporting Phase one trials in New York completing will enable us to filed for regulatory approval could be kind of hbr foresee U T. I M. Wes, which if approved will facilitate all evolution to a commercial stage company.
Ankit Mahadevia: Well, I'll leave it to Dr. Melnyk to give more detail on our ADAPTEO trial and our broader pipeline progress, but I will comment on how we're managing the business during the ongoing COVID-19 pandemic. Our top concern during this time is the safety of our patients, partners, and employees. And to that end, conducting trials in the COVID-19 setting has been an industry-wide challenge. While the incredible work of Spero's employees and partners allowed us to effectively navigate these challenges and remain on track to deliver data for ADAPTIA within our third quarter 2020 guideline, our ongoing assessment of the situation suggests an impact on certain future timelines.
Well I'll leave it to Dr. melnick to give more detail on our adapt field trial and or broader pipeline progress I will comment on how we're managing the business during the ongoing called in 19 pandemic.
Our top concern during this time safety of our patients partners and employees and to that end conducting trials in the corporate banking setting has been an industry wide challenge.
Well the incredible work of sparrows employees and partners have allowed us to effectively navigate these challenges and remain on track to deliver data for adapt yeah within our third quarter 2020 guidance.
Our ongoing assessment of the situation, suggesting impact a certain future timeline.
Specifically, we now expect to begin a rolling submission of a tepid economy, we are new drug application to the F.D.A. in first quarter 2021 pending positive phase three data and the F. Da's agreement with the completion submission expected in the second quarter 2021.
This represents an incremental modification of our previous guidance of completing the NDA submission in the first quarter 2021.
Ankit Mahadevia: Specifically, we now expect to begin a rolling submission of a tebupenem HVR new drug application to the FDA in the first quarter of 2021, pending positive phase three data and the FDA's agreement, with the completion of the submission expected in the second quarter of 2021. This represents an incremental modification of our previous guidance of completing the NDA submission in the first quarter of 2021. Additionally, due to COVID-19-related reductions in clinical research organization and clinical trial site capacity, we now plan to initiate a Phase 1 bronchoalveolar lavage clinical trial assessing the penetration of SPR-206 into the pulmonary compartment in the first half of 2021 rather than the second half of 2020 as stated previously. While COVID-19 has had an impact on some of our clinical timelines, it's also emphasized the need for our medicine.
Additionally, due to cope with 19 related reductions to clinical research organization and clinical trial thing capacity, we now plan to initiate a phase one bronco, all being able to vonage clinical trial assessing the penetration SPR people six into the pulmonary compartment in the first half of 2021, rather than the second half of 2020 stated previously.
Well covered 19 has had an impact on some of our clinical timelines. It's also emphasized the need for our medicines.
In this setting of cold that 19, the importance of preventing hospital admission to treatment in the community setting has never been greater now more than ever physicians would prefer to treat a complicated urinary tract infection outside of the hospital. If there was an effective all option available.
We outpatient treatment reduces exposure in two infectious disease, including called the 19 and offers a meaningful financial benefit to the hospital.
Further over the course of the pandemic physicians have become more comfortable using tele medicine, and they're looking for additional uncomplimentary methods to streamline and expand access to care for their patients.
All medicines that are reimbursed outside of the hospital DRG and shift character, the outpatient setting aren't attractive option to meet these goals.
The pandemic also highlights the need for a comprehensive approach to developing medicines to address current and future infectious threats. The role of antibiotics. In this strategy is a major focus of governments around the world and recently, we've seen major pharmaceutical companies increasing their long term commitment in this area such as with the recent amount.
And it became our action plan.
Importantly, while we are relying on such incentives to further develop our medicines, we do continue to benefit from our partnership with several agencies, including BARDA. The U.S. Department of defense and Detroit as well as from our relationships with corporate partners.
Ankit Mahadevia: In the setting of COVID-19, the importance of preventing hospital admission through treatment in the community setting has never been greater. Now, more than ever, physicians would prefer to treat a complicated urinary tract infection outside of the hospital if there was an effective oral option available. Timely outpatient treatment reduces exposure to infectious diseases, including COVID-19, and offers a meaningful financial benefit to the hospital. Furthermore, over the course of the pandemic, physicians have become more comfortable using telemedicine and are looking for additional and complementary methods to streamline and expand access to care for their patients. All medicines that are reimbursed outside of the hospital DRG and shift care to the outpatient setting are an attractive option to meet these goals. The pandemic also highlights the need for a comprehensive approach to developing medicines to address current and future infectious threats.
On the financial front, we ended the second quarter with $71.4 million in cash, which takes us into the first quarter 2021 beyond the adapt PEO topline data announcement this quarter and the expected initiation of our SPR 720 phase two clinical trial in the second half 2020.
Now to provide some more in depth discussion on spares pipeline in clinical trials I'll hand, it over to our Chief Medical Officer Dr., David Melanie.
Thank you very much on getting good afternoon, everybody a we've continued to make significant progress on our pipeline programs throughout the second quarter and into what is now be really part of the third quarter I'll begin with our lead candidate Tempe tandem hbr oral carbapenem that is currently.
Being evaluated in our adapt PEO phase three clinical trial.
Yeah, PEO is a non inferiority trial, comparing oral to be panel head to head versus intravenously administered heard of Tim Carbapenems that is most commonly used for complicated UTI high.
The trial has completed enrollment of 1372 patients in May and all patient follow up is now complete.
Call participants were randomized one to one basis and received either through tepid PEM IB preparing them for seven to 10 days. The primary end point to the trial is April clinical and Michael Biologic response.
Ankit Mahadevia: The role of antibiotics in this strategy is a major focus of governments around the world, and recently, we've seen major pharmaceutical companies increasing their long-term commitment in this area, such as with the recent announcement of the AMR action. Importantly, while we aren't reliant on such incentives to further develop our medicines, we do continue to benefit from our partnership with several agencies, including BARDA, the U.S. Department of Defense, and DITRA, as well as from our relationships with corporate partners. On the financial front, we ended the second quarter with 71.4 million dollars in cash, which takes us into the first quarter of 2021, beyond the ADAPTPO top-line data Now, to provide some more in-depth discussion on Spero's pipeline and clinical trials, I'll hand it over to our Chief Medical Officer, Dr. David Melnick.
Hi.
That concludes radicalisation be impacting pathogen test of cure in the microbiological intend to treat population. We continue to anticipate reporting topline results from the trial in the third quarter of 2020.
Well, we do not believes that the ongoing Cobiz 19 pandemic will impact our ability to report the adapt PEO topline data by the end to the third quarter, we announced today that our clinical research organizations were CR rose or experience experiencing a reduced.
Our city to conduct validate and analyze trials, which impact ongoing and planned phase one trial timelines as this relates to the Tempe term M.D.A. submission. We expect this reduce euro capacity to impact the phase one trials that are required for and D.A. submit.
Issue. Therefore, we now anticipate initiating a rolling into a submission to the FDA protecting tandem hbr uncomplicated UTI eye in the first quarter 2021 with completion of that submission in the second quarter.
Which is a change from our previous guidance ever completed and D.A. submissions in the first quarter.
We believe patients payers in positions alike will significantly benefit from the addition of an effective oral agent that keeps patients out of a hospital in restores the option to treat serious urinary tract infections caused by antibiotic resistant your pathogens micro.
David Melnick: Thank you very much, Ankit, and good afternoon, everybody. We've continued to make significant progress on our pipeline programs throughout the second quarter and into what is now the early part of the third quarter. I'll begin with our lead candidate, tepipenem HBR, an oral carbapenem that is currently being evaluated in our ADAPT-PO phase three clinical trial. ADAPT-PO is a non-inferiority trial comparing oral tepipenem head-to-head versus intravenously administered ertepenem, the carbapenem that is most commonly used for complicated UTI. The trial completed enrollment of 1,372 patients in May, and all patient follow-up is now complete.
You will surveillance data demonstrates that the prevalence of work one alone and surplus warring resistant Enterobacteriaceae CA continue to rise in both the hospital and community settings and this severely limits the activity. The currently available oral antibiotics.
Adapt PEO does not include and I do you read in the oral tabby Paramore, which is important because it will build the confidence of physicians to prescribed and oral antibiotic for complicated UTI.
As a replacement for IB therapy. Several recent clinical studies have demonstrated that substitution of oral antibiotic therapy in place of Ivy antibiotic therapy has premium effective strategy for treating serious infections, including and occurred I guess skeleton, one connections and gram negative bacteria.
David Melnick: Trial participants were randomized on a one-to-one basis and received either oral tepipenem or IV ertepenem for seven to 10 days. The primary endpoint of the trial is Overall Clinical and Microbiologic Response, which includes eradication of the infecting pathogen at test of cure in the microbiological intent-to-treat population. We continue to anticipate reporting top-line results from the trial in the third quarter of 2020. While we do not believe that the ongoing COVID-19 pandemic will impact our ability to report ADAPTPO top-line data by the end of the third quarter, we announced today that our clinical research organizations, or CROs, are experiencing a reduced capacity to conduct, validate, and analyze trials, which impact ongoing and planned Phase I trial timelines.
Yeah.
With approximately 60% bio availability for tabby, Pam and extensive pharmacokinetic and Pharmacodynamic data derived from our phase one studies, we feel confident that we'll have sufficient drug onboard and at the site of infection to allow for treatment with an oral agent alone. This is.
Further supported by Phase two data, which was previously generated by our Japanese partner made you second as well as an interim PK read any adapt PEO trial that confirmed the PK PD models supporting the dosing of Tempe patent Hbr I'd also highlight the Tempe, Panama as a powerful.
It's been market in Japan for over 10 years. So we were fortunate to have a significant safety database that add to the body of knowledge on this molecule.
Moving on from nine known for we're Tevye Panam two SPR 720, our oral drug candidate for the treatment of non tuberculosis Mycobacterial worth MTM infections, we previously announced phase one data in healthy patients demonstrating that repeated doses of one thing.
I wasn't milligrams administered once daily, we're safe and well tolerated and these are doses, which we believe we will produce clinical efficacy in patients. Following these results we spoke with the FDA to review SPR, seven Twentys development pathway and MTM.
David Melnick: As this relates to the tebupenem NDA submission, we expect this reduced CRO capacity to impact the Phase I trials that are required for the NDA submission. Therefore, we now anticipate initiating a rolling NDA submission to the FDA for tebupenem HBR and complicated UTI in the first quarter of 2021, with completion of that submission in the second quarter, which is a change from our previous guidance of a completed NDA submission in the first quarter. We believe patients, payers, and physicians alike would significantly benefit from the addition of an effective oral agent that keeps patients out of the hospital and restores the option to treat serious urinary tract infections caused by antibiotic-resistant uropathogens. Microbial surveillance data demonstrates that the prevalence of fluoroquinolone-resistant encephalosporin-resistant entrobacteriaceae continues to rise in both the hospital and community settings.
Importantly, the FDA confirmed that our planned phase two way trial, yes is the appropriate next step in development.
Longer term the development of SPR 720 will be in combination with other anti Microbials and house would be designed to measure patient reported outcomes.
Subject to FDA acceptance of the R&D for 720, which we expect in the second half of 2020, we plan to initiate a 28 day dose ranging phase two eight clinical trial evaluating SPR 720, as a monotherapy in NTM patients who are true.
Linked inexperience the goal of the trial is not only to assess the safety Tolerability and pharmacokinetics of SPR 720.
But also to assess the early micro biologic response to the drug candidate and outcome that if positive well highlight the activity of SPR 720, as a single agent in comparison to placebo. We continue to expect to initiate that phase II a trial in the second half of this year.
On SPR, two or six our IP next generation pine mixing agent that was developed as part of her Potentiator platform. We continue to work towards advancing this compound in conjunction with our partners at the department of Defense and Everest medicines, we are advancing.
David Melnick: And this severely limits the activity of the currently available oral antibiotics. Adapt PO does not include an IV lead-in in the oral tebupenomarm, which is important because it will build the confidence of physicians to prescribe an oral antibiotic for complicated UTIs as a replacement for IV therapy. Several recent clinical studies have demonstrated that substitution of oral antibiotic therapy in the place of IV antibiotic therapy has been an effective strategy for treating serious infections including endocarditis, skeletal infections, and gram-negative bacteremia. With approximately 60% bioavailability for tebifenam and extensive pharmacokinetic and pharmacodynamic data derived from our phase one studies, we feel confident that we'll have sufficient drug on board and at the site of infection to allow for treatment with an oral agent alone.
Youre to a six based on previous phase one data that demonstrated that the drug was well tolerated added dose of 300 milligrams daily for 14 consecutive days in healthy volunteers with no reported severe we're serious adverse events as well as no evidence of never talked.
Just city were clinically significant changes in laboratory tests, the absence of nephrotoxicity at or above the predictive therapeutic dose clearly differentiates SPR to us six from earlier generation probably mix since we announced in our press release that we are.
Delaying the initiation of our phase one bronco alveolar bosh BPL clinical trial from the second half of 2020 into the first half of 2021 due to cope with 19 related delays at RCR Rose we continue to expect to initiate a renal impairment study for.
David Melnick: This is further supported by phase two data, which was previously generated by our Japanese partner, Meiji Seika, as well as an interim PK read in the ADAPT-PO trial that confirmed the PK-PD models supporting the dosing of tebifenam HBR. I would also highlight that tebipenem in powder form has been marketed in Japan for over 10 years, so we were fortunate to have a significant safety database to add to the body of knowledge on this molecule.
SPR to a six in 2021.
I will now turn the call over to Kristina Larkin, our Chief operating officer, who will provide you with a review of the market opportunity for our pipeline products.
Well, thank you David and good afternoon, everyone.
Wow that development teams have been really hard at work on our phase three in India planning, the commercial and medical affairs team have been interacting with our future customers, including providers and payers as we really prepared heavy tenant hbr to advance towards the end da and launch if the data are positive.
David Melnick: Moving on from 994 or tebupenem to SPR 720, our oral drug candidate for the treatment of non-tuberculous mycobacterial or non-tuberculous fungal infections. We previously announced phase one data in healthy patients demonstrating that repeated doses of 1000 milligrams administered once daily were safe and well tolerated. And these are doses which we believe would produce clinical efficacy in patients. Following these results, we spoke with the FDA to review SPR720's development pathway in NTM. Importantly, the FDA confirmed that our planned Phase 2a trial is the appropriate next step in development. In the long term, the development of SBR 720 will be in combination with other antimicrobials, and trials would be designed to measure patient-reported outcomes. Subject to FDA acceptance of the IND for 720, which we expect in the second half of 2020, we plan to initiate a 28-day dose-ranging phase IIa clinical trial evaluating SPR720 as monotherapy in NTM patients who are treatment inexperienced.
Yeah. These interactions continue to highlight the unmet need for an oral option for cdti. In fact, it's been highlighted by our health care providers as the largest unmet need and really the largest opportunity and the antibiotic market today.
No I can't mentioned earlier that Coca night team has reinforced this push to keep patients out of hospital, especially for patients suffering from complicated urinary tract infections that don't require Ivy therapy.
It's really unfortunate that there is this growing number of complicated d. It you tie patient at present with resistant or we occurring infections and have failed prior therapy.
And this trend has translated into more hospitalizations and longer durations in the hospital. Since there are currently no effect of oil option to treat these patients.
Resistance to the most commonly used class of oral antibiotics for cdti, the full or Quinolones continue to rise.
And this has become especially true in the community setting where our most recent 2019 data now show greater than 20% resistance to equalize, which is the most common bacteria into yutai.
And need to rates are quickly catching up to the resistance that we've seen in the hospital or waitress high is 30%.
It is really our estimation that over 2 million patients a year would benefit from the convenience of a new oral therapy for cdti.
And our interactions to date with some of our key customers have further highlighted that have you kind of hbr has the potential to benefit all of our stakeholders, including healthcare providers payers and importantly, our patients.
David Melnick: The goal of the trial is not only to assess the safety, tolerability, and pharmacokinetics of SPR720 but also to assess the early microbiologic response to the drug candidate and outcome that, if positive, will highlight the activity of SPR-720 as a single agent in comparison to placebo. We continue to expect to initiate that Phase IIa trial in the second half of this year. On SPR-206, our IV next-generation polymyxin agent that was developed as part of our potentiator platform, we continue to work towards advancing this compound in conjunction with our partners at the Department of Defense and Everest Medicine. We are advancing SBR 206 based on previous phase one data that demonstrated that the drug was well tolerated at a dose of 300 mg daily for 14 consecutive days in healthy volunteers with no reported severe or serious adverse events, as well as no evidence of nephrotoxicity or clinically significant changes in laboratory tests.
Health care providers have relied on the Ivy Carbapenems as a standard of care in treating patients would have resistant or failed prior therapy for cdti from more than 40 years.
And the usage of Ivy Carbapenems and hospital and in the community setting has more than doubled over the last decade.
However, the lack of an oral formulation has created a challenge and helping these patients transition out of the hospital.
With yutai or to prevent unnecessary hospitalizations.
And this is more important than ever in this area of coded as hospitals are already at reduced capacity and I'm really preserving these beds for the seriously L.
No further payers do see the benefit to cover an oral alternative for ctr right because they will now have the opportunity to reduce the total cost of care keeping these patients out of the hospital.
It's important to remember that 10 dependent hbr will be primarily reimbursement of retail sector and paid as a pharmacy benefit and not under that hospital DRG.
David Melnick: The absence of nephrotoxicity at or above the predicted therapeutic dose clearly differentiates SPR-206 from earlier generation polymyxin. We announced in our press release that we are delaying the initiation of our Phase I bronchoalveolar lavage, BAL, clinical trial from the second half of 2020 into the first half of 2021 due to COVID-19-related delays at our CROs. We continue to expect to initiate a renal impairment study for SBR 206 in 2021. I will now turn the call over to Christina Larkin, our Chief Operating Officer, who will provide you with a review of the market opportunity for our pipeline products.
The benefits of the new oral therapy to potentially treat the growing number of patients resistant infections, coupled with the limitations of Ivy treatments in the outpatient setting provides great value foundation for the commercial launch of heavy pennant hbr that if approved really as I mentioned has the benefit to the benefit all of our key stake.
Holders I'm going to now turn the call over to Steve is going to provide you with the financial update.
Thank you Christian good afternoon, everyone I will provide an overview of sparrows financial results for the quarter ended June 32020.
The second quarter total revenue was 1.7 million compared to revenues of 2.2 million in the second quarter of from 29 chain.
Reimbursement under sparrows contract with Biomedical advanced research and development Authority BARDA.
For qualified so you kind of Hbr expenses slightly higher in the second quarter 2020 compared to the same period between 19.
Christina Larkin: Well, thank you, David. And good afternoon, everyone.
But this increase was offset by a decrease in SPR chose six funding from the U.S. National Institute of allergy and infectious disease.
Christina Larkin: While the development teams have been really hard at work on our phase three and NDA planning, the commercial and medical affairs teams have been interacting with our future customers, including providers and payers, as we really prepare Tevipenem HVR for advance towards NDA and launch if the data are positive. These interactions continue to highlight the unmet need for an oral option for CUTI. In fact, it's been highlighted by our health care providers as the largest unmet need and really the largest opportunity in the antibiotic market today. Now, Ankit mentioned earlier that COVID-19 has reinforced this push to keep patients out of the hospital, especially for patients suffering from complicated urinary tract infections that don't require IV therapy. It's really unfortunate that there is this growing number of complicated UTI patients that present with resistant or reoccurring infections and have failed prior therapy.
As a reminder, BARDA has committed to provide a total non dilutive funding of $44 million Spiro inclusive of 10 million and funding for.
From the defense threat reduction agency.
We've received 16.3 million committed funding from BARDA as of the end of June.
2020.
And our second option for 12.7 million in additional non dilutive funding that remains exercisable by BARDA.
The second quarter 2020, R&D expenses were $15.7 million 30 $12 million in side and the same period 2019.
The increase in the second quarter, 2020, which due to greater spending on a heavy that TTR program.
Research and all the expenses declined quarter over quarter. This year due to completion of enrollment to meet that field trial, we announced in early may.
We continue expect that R&D expenses increased 2020 relative to 2019 due to greater expense associated with progressing our pipeline candidates.
In the second half of 2020, we expect to recognize researching on expenses associated with tight phenom Hbr phase one clinical trials.
Christina Larkin: This trend has translated into more hospitalizations and longer durations in the hospital since there are currently no effective oral options to treat these patients. Resistance to the most commonly used class of oral antibiotics for CUTI, the fluoroquinolones, continues to rise. And this has become especially true in the community setting, where our most recent 2019 data now show greater than 20% resistance to E. coli, which is the most common bacteria in CUTI. And these rates are quickly catching up to the resistance that we've seen in the hospital, where rates are as high as 30%.
And adapt PL clinical trial wind down as well as SPR 720 phase two way clinical trial initiation.
General and administrative expenses for the second quarter 2000 $24.5 million.
Which is higher than the so $2.8 billion reported in the same for your 2019, primarily due to increased headcount.
We expect unit expenses to increase your 2022 additional headcount professional fees and infrastructure required to support tell you kind of hbr for potential regulatory approval.
As well as supports various other product candidates.
Our net loss for the second quarter ended June 30, 2020 was 17.5 million.
Were 85 cents per common share compared to net loss of 13.2 million.
Christina Larkin: It is really our estimation that over 2 million patients a year would benefit from the convenience of a new oral therapy for CTI. And our interactions to date with some of our key customers have further highlighted that Tebupenem HVR has the potential to benefit all of our stakeholders, including health care providers, payers, and importantly, our patients. Healthcare providers have relied on IV carbapenems as a standard of care in treating patients that have resistance or have failed prior therapy for CUTI for more than 40 years, and the usage of IV carbapenems in the hospital and in the community setting has more than doubled over the last decade. However, the lack of an oral formulation has created a challenge in helping these patients transition out of the hospital with UTI or prevent unnecessary hospitalization.
Or 74 cents per common share reported to the same period and 29 team.
Increase was largely attributable to greater clinical development activity.
As of June 32020 through had cash cash equivalents or 70 $71.4 million.
We believe for their existing cash cash equivalents and Mark I'm, just curious together with committed funding from the BARDA contract and other non dilutive funding commitments will be sufficient to fund our operations into the first quarter 2021.
Further details on our financials, including comparisons of the quarters ended June 30, 2020 in June 32019.
Please refer to our 10 10-Q filed with the FCC today.
We'd now like to open the call for questions operator.
At this time, we will be conducting a question and answer session. If he would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question Q you May press star to if he would like to remove your question from the Q.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the starkey one moment, please while we pull for questions.
Christina Larkin: And this is more important than ever in this era of COVID, as hospitals are already at reduced capacity and are really preserving these beds for the seriously ill. Furthermore, payers do see the benefits of covering an oral alternative for CETI because they will now have the opportunity to reduce the total cost of care by keeping these patients out of the hospital. It's important to remember that Tevipenem HBR will be reimbursed primarily in the retail sector and paid as a pharmacy benefit and not under that hostile DRG. The benefits of the new oral therapy to potentially treat the growing number of patients with resistant infections, coupled with the limitations of IV treatments in the outpatient setting, provide this great value foundation for the commercial launch of Kevipenem HBR, which, if approved, really, as I mentioned, has the potential to benefit all of our key stakeholders. I'm going to now turn the call over to Steve, who's going to provide you with a financial update.
Our first question is from redo Berle from Cowen. Please proceed with your question.
Hi, guys. Thanks for thanks for taking the question I've got a couple the first one is can you keep with scrap the outstanding type dependent phase one did a phase ones needed for the M.D. submission and also as a follow up can you take us through.
Your most current thoughts on potential pricing.
Thanks for two for the for the question. It's nice to hear from you I will take the first question and I will pass the second question on pricing to the.
The Christina.
So as it relates to our ongoing phase one studies, we publish those on a clinical trial that goes and I would note that not all of the studies published there are a critical path or or necessary for the end da or the phase. One studies that are ongoing that you'll see there are the bioequivalent study the drug drug interaction study.
David mentioned in.
Last quarter's call as well as a study in renally impaired patients.
And then my second question. Please go ahead, please within <unk> Oh, the that pricing question.
And that I'll pass the Christina.
[laughter] things on cat.
As I think you know Ritu, we haven't.
Stephen J. DiPalma: Thank you, Christina. Good afternoon, everyone.
Really spoken about the pricing publicly yet and I know that you know as we advance work are going to make that publicly available at a later date, but I can give you. Some bookends of some of the work that we've done so far that guides us to the way our payers are thinking about pricing and they're looking at the adjudication of of how to think about pricing.
Stephen J. DiPalma: I will provide an overview of Spero's financial results for the quarter ended June 30, 2020. In the second quarter, total revenue was $1.7 million, compared to revenues of $2.2 million in the second quarter of 2019. Reimbursement under Spero's contract with the Biomedical Advanced Research and Development Authority, BARDA, for qualified tebupenem HBR expenses was slightly higher in the second quarter of 2020 compared to the same period in 2019, but this increase was offset by a decrease in SBR 206 funding from the U.S. National Institute of Allergy and Infectious Disease.
For US is what were relieving them in the medical expense or cost of either outpatient therapy or the prevention of a hospitalization. So that's really great news that we have that further guidance from the payers.
And a you know through some of the initial beta work, what we've seen is that potentially treatment cost up to about $5000 for treatment costs could be you know the higher end of the way that they're viewing that pricing models, what does give us some level of flexibility to think about on 5000 per course of treatment not per day.
Stephen J. DiPalma: As a reminder, BARDA has committed to provide a total of $44 million to Spero, inclusive of $10 million in funding from the Defense Threat Reduction Agency. We've received $16.3 million of the committed funding from BARDA as of the end of June 2020, and we have a second option for $12.7 million in additional non-dilutive funding that remains exercisable by BARDA. The second quarter of 2020 R&D expenses were $15.7 million compared to $12 million in the same period of 2019. The increase in the second quarter of 2020 was due to greater spending on the Pebby Benham HPR program. Research and development expenses declined quarter over quarter this year due to the completion of enrollment in the ADAPT-PO trial that we announced in early May. We continue to expect that R&D expenses will increase in 2020 relative to 2019 due to the greater expense associated with progressing our pipeline candidates.
Just to give you some some ideas I think in our corporate deck, we used $350 as price per day as a place holder given that's where some of the branded Gram positive agents have landed.
Got it and I'm going to squeeze one last question and for 720 can you describe what Michael biological and point you'd like to use for the phase two when when we might see paid off from that study.
Thanks for taking all the questions.
You're welcome to do and thanks for the questions. So that's a two part question on the second component of that in terms of when we might see data.
We haven't committed to that in the public for him and as we get closer to the initiation of the trial will find the appropriate public venue to communicate that as to your the first part of your question in terms of microbiological measurements I'll pass that question to David.
Yeah. The study is designed first and foremost to look at safety and pharmacokinetics in patients.
In terms of micro biologic endpoints, we will be looking at change in that true burden as measured by quantitative sputum cultures.
Stephen J. DiPalma: In the second half of 2020, we expect to recognize research and development expenses associated with tedipenum HPR phase one clinical trials and AdaptPO Clinical Trial Wind Down, as well as SBR 720 Phase 2a Clinical Trial Initiation. General and administrative expenses for the second quarter of 2020 were $4.5 million, which is higher than the $3.8 million reported in the same period of 2019, primarily due to increased headcount. We expect G&A expenses to increase through 2020 due to additional headcount, professional fees, and infrastructure required to support tele-dependent HPR through a potential regulatory approval, as well as support Spero's other product candidates. Our net loss for the second quarter ending June 30, 2020, was $17.5 million, or $0.85 per common share, compared to a net loss of $13.2 million, or $0.74 per common share, reported for the same period in 2019. This increase was largely attributable to greater clinical development activity.
So we'll be change in sputum bacterial burden overtime.
Great. Thanks.
Yeah.
The next question is from Louise Chen with Controller. Please proceed with your question.
Hi, Thanks for taking my questions here. So my first question here given the impact of coal bid 19, do you think the government will eventually stockpile antibiotics.
Thank you.
Salesforce is it's still too early to bring the reps actually yen just any color you could provide there would be helpful.
And then last question I have here as we get asked this a lot, but why did prior antibiotic launches not gain a lot of traction and how will your product be different. Thank you.
Yeah.
Thanks.
Luisa further questions. We appreciate it.
So it's easy to the first part of the of your your question. Yeah, you know as as we noted given the the obvious impact that infection has had on every aspect of our life and there certainly is quite a bit of heightened focus from governments around the world in terms of preventing ER and defending a.
Against the next infection and so we've seen BARDA. It takes a prominent role in planning ahead for the nation's defense both against that Corona virus, but also a bacterial threats and even prior to call that 19, you've seen an example of a fairly comprehensive and robust stockpile agreement and we would expect.
Next is based on the way federal funding has gone that we'll see that continue I certainly from our part we're pleased to have a development relationship with BARDA that allows us to really demonstrate not only what the medicine can do for patients suffering from complicated urinary tract infection, but also a downstream will help us demonstrate the where with.
Stephen J. DiPalma: As of June 30, 2020, Spero had cash and cash equivalents of $71.4 million, and they believe that our existing cash, cash equivalents, and marketable securities, together with committed funding from the BARDA contract and other non-diluted funding, can be used to fund our operations into the first quarter of 2020. Further details on our financials, including comparisons of the quarters ended June 30, 2020 and June 30, 2019. Please refer to our 10-Q file with the SEC today. We'd now like to open the call for questions. Operator?
Paul This agent has to be able to treat other threats, including the microbial defense threats that are BARDA is focus.
On the second point you know looking ahead, we take a step wise approach to thinking about building. The company certainly first is that we want to deliver this quarter on the adapt PEO trial.
To note to be able to demonstrate with its medicine to do and then going forward from there towards Andy I will take a step wise approach and a capital efficient and prudent approach to developing and we won't have been bringing on.
Operator: At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star two.
To that point, we'll take a sort of a staged approach to bring on reps and as you know I wouldn't expect them to be to be onboard in the near term.
In terms of the third question and this is a macro question that really has been the foundational principle around building Spiro in the pipeline and it's our philosophy, we've been consistent about this for for many years that the hallmark of affected and sustainable antibiotics has two primary components.
Operator: One moment, please, while we poll for questions. Our first question is from Ritu Baral of Cohen. Please proceed with your question. Hi guys, thanks for taking the time to take the question. I've got a couple. The first one is, can you please list for us the outstanding tepipenem phase one needed, phase ones needed for the NDA submission? And also, as a follow-up, can you take us through your most current thoughts on potential pricing?
The first is a two unmet needs and what we mean by that is a population of infection prevalence today.
Secondly is no alternative generic therapies and in our case with heavy Panam. There are no alternative generic or brand of therapies and that could be the need.
The second component.
Dresses, where we did a little bit these medicines to patients and it's our philosophy that delivery medicines to patients outside of the hospital and outside the hospital DRG is the whole mark for successful launches, whether the recent such as Eric case or more historical.
Ankit Mahadevia: Thanks, Ritu, for the question. It's nice to hear from you. I will take the first question, and I will pass the second question on pricing to Christina. As for our ongoing Phase 1 studies, we published those on clinicaltrial.gov, and I would note that not all of the studies published there are critical path or necessary for the NDA. The Phase 1 studies that are ongoing that you'll see there are the bioequivalence study, the drug-drug interaction study that David mentioned in last quarter's call, as well as a study in renally impaired patients. And then, from my second question, go ahead.
Thank you.
Our next question is from Steven.
Willey Stifel. Please proceed with your question.
Yes, thanks for taking the question and I'm.
Looking forward to the data.
Later this quarter.
Can you, maybe just speak a little bit about how the extension on the NDA filing.
Impacts the piece of commercial build out and just kind of here and.
And I guess prescriber engagement if at all and then on on the NTM study I know you talked about.
Looking at patient reported outcomes, perhaps as as part of this phase two a.
What are your thoughts just around I guess, the current PCR ROE instrument that has been used thus far for clinical development and I think there's still a little bit of the debate as to how well that captures.
Unknown Speaker: Unknown Speaker Go ahead, please Ritu. Ritu Baral Oh, the pricing question.
Christina Larkin: Yeah, and that I'll pass to Christina.
Patient outcomes and just curious if you have any thoughts as to how you would like to see that improves.
Christina Larkin: Thanks, Ankit. As I think you know, Ritu, we haven't really spoken about pricing publicly yet, and I know that, as we advance forward, we're going to make that publicly available at a later date, but I can give you some examples of some of the work that we've done so far that guides us to the way our payers are thinking about pricing. And they're looking at the adjudication of how to think about pricing for us is what we're relieving their medical expense or cost of either outpatient IV therapy or the prevention of a hospitalization. So that's really great news that we have that further guidance from the payers. And, you know, through some of the initial data work, what we've seen is that potentially treatment costs up to about $5,000 per treatment cost could be, you know, the higher end of the way that they're viewing that pricing model. So, it does give us some level of flexibility to think about $5,000 per course of treatment, not per day. Just to give you some ideas, I think in our corporate deck, we use $350 as a price per day as a placeholder, given that's where some of the branded gram-positive agents have landed.
Thank you for the questions we appreciated as to your first question. The way that we think about delivering kept dependent to patients isn't two parts are the first part as Kristina mentioned is engaging our customers and thats patients physicians.
And payers are early and often just to what we heard from them is is incredible amount of demand for an effective oral agent for complicated UTI and.
And it's important for us to engage with these customers and continues to develop the market puts any kind of now going forward and the dawn and an anda filing a potential acceptance and so that will continue on its pace and setting of a successful adapt PEO will certainly accelerate.
The second component of getting 10 10 to 12 patients is building the infrastructure in mechanics, and and and the boots on the ground to be able to deliver cabin kind of once approved you know as you might imagine that you're towards our PDUFA date, and so the ultimate PDUFA date, We'll guide how we started to temporize.
Build up.
And what we've heard from customers is really exciting in partnering in terms of the true unmet need for an oil carbapenem.
As it relates to your second question on 720, they're Oh, we have been queens too to interact with the FDA as we've noted prior.
Hi, or press releases about the opportunity to to think about how we can develop 720 for patients.
We see the opportunity in this setting of having a clinical and patient reported outcome to be able to drive redoubts faster and also in a way that's more consistent with how physicians and patients ultimately look at NTM and as a sea change and NTN is that it's more important as we've heard from the FDA.
David Melnick: Got it. And I'm going to squeeze one last question in. For 720, can you describe what microbiological endpoint you'd like to use for phase two and when we might see data from that? Thanks for taking all the questions.
Outcome to show that a patient equals better and one can manage the disease as opposed to try to simply clear the microbiology paradigm shift mirrors, what we've seen with HIV in the past whereby now there's a paradigm of long term disease management persistently disease or gravitation as you've noted.
We're taking a step wise approach to developing that PR, though and we'll be using some of the learnings from our ongoing phase two as well as continued dialogue with the patient and physician community to develop that.
David Melnick: You're welcome, Ritu, and thanks for the questions. So that's a two-part question. On the second component of that, in terms of when we might see data, we haven't committed to that in a public forum, and as we get closer to the initiation of the trial, we'll find the appropriate public venue to communicate that. As to the first part of your question, in terms of microbiological measurements, I'll pass that question to David.
And it's our view that with an oral agent that has a good safety and tolerability profile as well as effectiveness. We have a very wide range of options to demonstrate what 720 can do when that said.
Okay. That's helpful. And then maybe just a quick follow up on the southern 20 fronts, presumably if the phase two way trial goes.
Yes, well or as planned.
The next study would involve presumably something with a bit longer treatment duration can you just remind us kind of what your current Tox package allows you and.
David Melnick: Yeah, the study is designed first and foremost to look at safety and pharmacokinetics in patients. In terms of microbiologic endpoints, we will be looking at change in bacterial burden as measured by quantitative sputum culture. So it will be change in sputum bacterial burden over time.
In terms of coverage and.
You know is is that preclinical data something that you would be generating in parallel to the phase two is such that the transition time into a longer duration study wouldn't necessarily be constrained by the need for greater talks coverage. Thanks.
Christina Larkin: Great, thank you. The next question is from Luis Chen with Contour. Please proceed with your question. Hi, thanks for taking my questions here.
Yeah. Thanks, a great question, Steve what I'll note is both in this setting up our primate and other species toxicology data as well as our phase one we've been pleased to see that we have a very safe and well tolerated compound that we're excited to go demonstrate what can be it in a patient study in phase two.
Ankit Mahadevia: So my first question is, given the impact of COVID-19, do you think the government will eventually stockpile antibiotics? And then where are you with the hiring of your sales force? Is it still too early to bring the reps in? Just any color you could provide there would be helpful. And then last question I have here is, we get asked this a lot, but why did prior antibiotic launches not gain a lot of traction, and how will your product be different? Thank you.
To your specific question will be taking that approach on understanding the longer term exposures for 720.
Such that we'll be able to really drive the phase to be in a timely fashion.
Great. Thanks for taking my questions.
Our next question is from Rahm City, there Ju with H.C. Wainwright. Please proceed with your question.
Thanks, very much for taking my questions. I was wondering if you could just to verify for me I believe there should not be any data integrity issues for the adapt PEO study just because of covert 19, but I just wanted you to verify that you're good things.
Ankit Mahadevia: Thanks. Luis, for the questions. We appreciate it. So to the first part of your question, you know, as we know,
Thanks from a credit to our team the short answer is no where we're confident about the dataset will deliver this quarter.
Ankit Mahadevia: You know, as we noted, given
Ankit Mahadevia: The obvious impact that the infection has had on every aspect of our lives, there certainly is quite a bit of heightened focus from governments around the world in terms of preventing and defending against the next infection. And so we've seen BARDA take a prominent role in planning ahead for the nation's defense, both against the coronavirus and also bacterial threats. And even prior to COVID-19, we've seen an example of a fairly comprehensive and robust stockpile agreement. And we would expect that, based on the way federal funding has gone, that we'll see that continue.
Fantastic and then secondly, I was wondering if you could talk a little bit about the scenario analyses you've been running internally regarding the kind of market environment, you might have to negotiate.
In introducing time dependent hbr so.
We don't really know what the covert 19 situation is going to be like months from now six months from now a year from now I don't think anybody can really predict for sure, but maybe you can talk through a few of the scenarios that you're modeling and how you intend to potentially overcome some of the challenges and curve balls that might be thrown your ways.
You execute the commercialization part of the strategy.
Ankit Mahadevia: Certainly, from our part, we're pleased to have a development relationship with BARDA that allows us to really demonstrate not only what the medicine can do for patients suffering from complicated urinary tract infections, but also downstream, it will help us demonstrate the wherewithal this agent has to be able to treat other threats, including the microbial defense threats that are BARDA's focus. On the second point, you know, looking ahead, we take a stepwise approach to thinking about building the company. Certainly, first, we want to deliver this quarter on the ADAPT-PO trial to note, to be able to demonstrate what this medicine can do. And then going forward from there towards NDA, we'll take a stepwise approach and a capital efficient and prudent approach to developing. And, you know, we won't be bringing in new reps, and to that point, we'll take a sort of a staged approach to bringing in new reps. And, as you note, I wouldn't expect them to be on board in the near term.
Thanks for the question ROM I'll pass that would over the Christina.
Yeah. Thanks, Tom Tonight on yes, we've definitely been closely monitoring what other companies have been doing facing this pandemic with access and the clinicians offices I think you know, though one great thing that we've been we have the opportunity to do it kind of have an opportune to learn from what's been going on in the marketplace today.
It does appear that you know doctors' offices are opening up across the country, which I don't do you think that that signal that a good you know some good signals about us as this one scenario planning is still gaining access and the doctor's offices.
Simultaneous in parallel to that process. We've also been developing a a great digital strategy and so that's part of what we've been doing we have seen in follows literature about you know how physicians are accessing a you know digital means and contacting back to the company. So those are some of the scenarios that we are actively looking at it.
Flooring and monitoring you know those that have been successful.
Okay, Great and then lastly, it was just a general question kind of if we look at your pipeline of innovative antibiotics I think we've all seen some of the developments that have been occurring within the context of big pharma and the stance that some of them have been taking.
Ankit Mahadevia: In terms of the third question, and this is a macro question that really has been the foundational principle around building Sparrow in the pipeline, and it's our philosophy, and we've been consistent about this for many years, that the hallmark of effective and sustainable antibiotics has two primary components. The first is true unmet need, and what we mean by that is a population of infection prevalence today. Secondly, there are no alternative generic therapies, and in our case with Tevipenem, there are no alternative generic or branded therapies that could meet the need. The second component addresses where we deliver these medicines to patients, and it's our philosophy that delivering medicines to patients outside of the hospital and outside of hospital DRG is the hallmark of successful launches, whether they're recent, such as Aerocase, or more historic.
Suggesting that there should be alternative funding mechanisms established specifically to address the dearth of novel antibiotics and make it economically worthwhile for innovators in that space can you talk a little bit about how that picture has changed how potentially it might be relevant specifically just some of your development.
Stage programs and what the perspective might be going forward and from an economic standpoint, how that might.
Allow sparrow to benefit.
Yeah. Thanks for the question, Rob I'll make the a separate the question in two parts I would say first I'd make the statement that you know our philosophy all along has been to develop medicines it market opportunities that are large and sustainable a with or without the benefit.
Ankit Mahadevia: Thank you.
Of additional incentives.
Ankit Mahadevia: Our next question is from Stephen. Willie Stiefel. Please proceed with your question.
That all said we have seen the same trends that note that both in terms of activity in the United States as well as in Europe in developing robust incentives for anti microbial development as well as the Omar action fund that was unveiled and the second quarter that would.
Ankit Mahadevia: Yeah, thanks for taking the question. I'm looking forward to the data later this quarter. Can you maybe just speak a little bit about how the extension of the NDA filing impacts the pace of Commercial Buildout and just kind of hair and, I guess, prescriber engagement, if at all. And then on the NTM study, I know you talked about. Looking at patient-reported outcomes, perhaps, as part of this Phase 2a. What are your thoughts around, I guess, the current PRO instrument that has been used thus far for clinical development? And I think there's still a little bit of a debate as to how well that captures patient outcomes, and I'd be just curious if you have any thoughts as to how you would like to see that improved.
Commit a billion dollars to the investment and development and have a further antimicrobials, we see that as a welcome development than certainly pipeline medicine, such as SPR tools, six and others I will be excellent candidates for.
That funded and others. So we're heartened by that you see that as another way to win for Cerro, though I would reiterate that we.
Explicit we've chosen the pipeline medicines and markets, we have to be able to succeed no matter, what the landscape looks like outside of our walls.
Great. Thank you very much.
As a reminder, if he would like to ask a question. Please press star one on your telephone keypad.
Ankit Mahadevia: Thanks, Steve, for the questions. We appreciate it.
Our next question is with Jason Gerberry with Bank of America. Please proceed with your question.
Ankit Mahadevia: As to your first question, the way that we think about delivering Tebupendant to patients is in two parts. The first part, as Christina mentioned, is engaging our customers, and that's patients, physicians, and payers, early and often. Just to, you know, what we've heard from them is this incredible amount of demand for an effective oral agent for complicated UTI, and it's important for us to engage with these customers and continue to develop the market for tebupendant now, going forward, and even beyond an NMDA filing and potential acceptance. And so that will continue at its pace, and in the setting of a successful ADAPTPO, will certainly accelerate. The second component of getting tebupendant to our patients is building the infrastructure and mechanics and the boots on the ground to be able to deliver tebupendant once approved. As you might imagine, that's geared towards our PDUFA date, and so the ultimate PDUFA date will guide how we start to temporize that buildup.
Oh, hi, good afternoon, because she owns our Jason Thanks for taking my questions.
A few if I may what can you elaborate what would be okay clinical package upped the ante a entail and second would be do you have as filed with the FDA that single phase three can support approval.
And you talked about early on a call back your from Phase one study.
Like I'm talking about three Uptown district cooking fraction Reno looks like there was maybe focusing more on the safety side. They talk about the paper on April villains, what are you trying to achieve.
If that you have already you know done some thirtyth in terms of a struggling PK data out the oral versus the IB that doesn't need to be doing that so so are you trying to bridge some sort of formulation and what are you trying to achieve there and you know how hot it how.
Hi, how important that video for idea package. Thank you.
Yeah, Thanks for the questions.
Appreciate it.
So to your first question as we mentioned that the studies that are on clinical trials that does not not all of them that are there are required for the NDA package, but as you've already listed.
Ankit Mahadevia: And what we've heard from customers is really exciting and heartening in terms of the true unmet need for an oral carbapenem. As it relates to your second question on 720, we have been pleased to interact with the FDA, as we've noted in prior press releases, about the opportunity to think about how we can develop 720 for patients. We see the opportunity, in the setting of having a clinical and patient-reported outcome, to be able to drive readouts faster and also in a way that's more consistent with how physicians and patients ultimately look at NTM. You know, the sea change in NTM is that it's more important, as we've heard from the FDA adcom, to show that a patient feels better, and one can manage the disease as opposed to trying to simply clear the microbiology.
Those are the studies were focused on to be able to deliver on the NDA on the second question as we've noted in our public comments.
We had a multiple interactions with FDA confirming that the adapt PEO trial is the single pivotal trial that's required for a after the approval in for the treatment of complicated urinary tract infections.
And as it relates to the studies you know the focus of the Bioequivalent study is that some of the incremental modifications. We made in terms of the commercial supply.
TV panel match up to the clinical supply and again, we're fortunate to have a significant longstanding experience on the behavior at 10 depend on the different formulations, both in our hands as well as from our partner made you shake up.
And if the box so it's the formulation that which is used being used in phase three is at the same or different than the Ah. That's the final commercial and body one.
Ankit Mahadevia: The paradigm shift mirrors what we've seen with HIV in the past, whereby now there's a paradigm of long-term disease management versus disease eradication. As you've noted, we're taking a stepwise approach to developing that PRO, and we'll be using some of the learnings from our ongoing Phase 2, as well as continued dialogue with the patient and physician community, to develop that. And it's our view that with an oral agent that has a good safety and tolerability profile, as well as effectiveness, we have a very wide range of options to demonstrate what 720 can do in that setting.
No as I mentioned in as is typical we'll make some minor modifications, including the you know, including the present the the diesel presentation on the tablet as we go to commercial.
Okay. Thank you.
It appears there are no further questions at this time I would like to turn the floor back over to management for concluding comments.
Thank you operator, and as you can probably tell we're excited about the prospects for our drug candidates and we're looking forward to reporting heavy tedom HDR phase three data this quarter I invite everyone to join US at our next webcast presentation at the Cantor virtual health care conference bigger.
David Melnick: Okay, that's helpful. And then maybe just a quick follow up on the 720 front. Presumably, if the phase 2a trial goes well or as planned, the next study would involve something with a bit longer treatment duration. Can you just remind us kind of what your current talk package allows you in terms of coverage? And, you know, is that preclinical data something that you would be generating in parallel to the Phase II AA such that the transition time into a longer duration study wouldn't necessarily be constrained by the need for greater tox coverage? Thanks.
Getting on September 15th.
I wish everyone, a very happy in safe summer. Thank you very much.
This concludes today's conference. Thank you for your participation you may disconnect your lines at this time.
[noise].
David Melnick: Yeah, thanks. Great question, Steve. What I'll note is both in the setting of our primate and other species toxicology data, as well as in phase one, we've been pleased to see that we have a very safe and well-tolerated compound that we're excited to go demonstrate what it can do in a patient study in phase two. To your specific question, we'll be taking an approach to understanding the longer-term exposures for 720, such that we'll be able to really drive the phase to be in a timely fashion.
David Melnick: Great. Thanks for taking my questions.
Ankit Mahadevia: Our next question is from Ram Sivaraju, with H.C. Wainwright. Please proceed with your question.
Ankit Mahadevia: Thanks very much for taking my questions. I was wondering if you could just verify for me that there should not be any data integrity issues for the ADAPT PO study just because of COVID-19, but I just wanted you to verify that, if you could.
Ankit Mahadevia: Thanks, Ram. Credit to our team. The short answer is no. We're confident about the data set we'll deliver this quarter.
Christina Larkin: Fantastic And then, secondly, I was wondering if you could talk a little bit about the scenario analyses you've been running internally regarding the kind of market environment you might have to negotiate in introducing tebepenem HBR. So, you know, if we don't really know what the COVID-19 situation is going to be like months from now, six months from now, a year from now, I don't think anybody can really predict for sure. But maybe you could talk through a few of the scenarios that you're modeling and how you intend to potentially overcome some of the challenges and curveballs that might be thrown your way as you execute the commercialization part of the strategy.
[music].
Ankit Mahadevia: Thanks for the question, Ram. I'll pass that one over to Christina.
Christina Larkin: Yeah, thanks so much. Yes, we've definitely been closely monitoring what other companies have been doing with access to clinicians' offices. I think, you know, the one great thing that we've been, and we have the opportunity to do, is kind of learn from what's been going on in the marketplace today. It does appear that, you know, doctors' offices are opening up across the country, which I do think that that signals a good, you know, some good signals about us as this one scenario planning of still gaining access to doctors' offices, simultaneous and parallel to that process. We've also been developing a great digital strategy, so that's part of what we've been doing. We have seen and followed literature about, you know, how physicians are accessing, you know, digital means and returning to the company. So those are some of the scenarios that we are actively looking into and exploring and monitoring, you know, those that have been successful.
Ankit Mahadevia: Okay, great. And then lastly, it was just a general question, kind of, if we look at your pipeline of innovative antibiotics. I think, you know, we've all seen some of the developments that have been occurring, you know, within the context of big pharma and the stance that some of them have been taking, suggesting that there should be alternative funding mechanisms established specifically to address the dearth of novel antibiotics and make it economically worthwhile for innovators in that space. Can you talk a little bit about how that picture has changed, how potentially it might be relevant specifically to some of your development stage programs, and what the prospects might be going forward, and from an economic standpoint, how that might allow Spero to benefit?
Ankit Mahadevia: Yeah, thanks for the question, Ram. I'll separate the question into two parts. I would say first, I would make the statement that, you know, our philosophy all along has been to develop medicines in market opportunities that are large and sustainable, with or without the benefit of additional incentives. That all said, we have seen the same trends that you note, both in terms of activity in the United States, as well as in Europe, in developing robust incentives for antimicrobial development, as well as the AMR Action Fund that was unveiled in the second quarter that would We see that as a welcome development, and certainly pipeline medicines such as SPR-206 and others will be excellent candidates for that fund and others. So we're heartened by that. We see that as another way to win for Spero, though I would reiterate that we've explicitly chosen the pipeline medicines and markets we have to be able to succeed, no matter what the landscape looks like outside of our wall.
Ankit Mahadevia: Great, thank you very much.
Operator: As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question is from Jason Gerberi with Bank of America. Please proceed with your question.
Operator: Oh, hi. Good afternoon. This is Chi on for Jason.
Ankit Mahadevia: Thanks for taking our questions, a few. If I may, can you elaborate on what the clinical package of the NDA entail? And second, do you have a spot with the FDA where a single phase three can support approval? And you talked about earlier in the call that you have some phase 130s, looks like you talked about three of them, the structural interaction, renal, looks like those may be focusing more on the safety side. Can you talk about phase one bioequivalence? What are you trying to achieve? It seems that you've already done some studies in terms of showing PK data of the oral versus the IV. So it doesn't seem to be doing that. So are you trying to bridge some sort of formulation gap? And what are you trying to achieve there? And, you know, how important is that to the overall NDA package? Thank you.
[music].
Ankit Mahadevia: Thanks for the questions. I appreciate it.
Ankit Mahadevia: You know, so to your first question, as we mentioned, the studies that are on clinicaltrials.gov, not all of them that are there are required for the NDA package, but as you've already listed, those are the studies we're focused on to be able to deliver on the NDA. You know, on the second question, as we've noted in our public comments, we've had multiple interactions with FDA confirming that the ADAPT-PO trial is the single pivotal trial that's required for FDA approval for the treatment of complicated urinary tract infections. And as it relates to the studies, you know, the focus of the bioequivalence study is to see whether some of the incremental modifications we've made in terms of the commercial supply of tebupenem match up to the clinical supply. And again, we're fortunate to have significant and longstanding experience of the behavior of tebupenem in different formulations, both in our hands as well as from our partner, Meiji Seika.
Ankit Mahadevia: And it's the box, so it's the formulation that was being used in phase three. Is it the same or different from the final commercial embodiment?
Ankit Mahadevia: No, as I mentioned, and as is typical, we'll make some minor modifications, including the present, the visual presentation of the tablet as we go to commercial.
Operator: It appears there are no further questions at this time. I would like to turn the floor back over to management for closing comments.
Ankit Mahadevia: Thank you, Operator. And as you can probably tell, we're excited about the prospects for our drug candidates, and we're looking forward to reporting Tevipenem-HVR Phase III data this quarter. I invite everyone to join us for our next webcast presentation at the Canter Virtual Healthcare Conference beginning on September 15th. I wish everyone a very happy and safe summer. Thank you very much. This concludes today's conference. Thank you for your participation. You may disconnect your lines at this time.
Operator: Copyright 2020 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent.
Operator: [inaudible]
Operator: Copyright 2020 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent.
Operator: [inaudible] Unknown executive, Unknown attendee, Boobalan Pachaiyappan, Ankit Mahadevia, Kamal Hamed, Satyavrat Shukla, Ted Jenkins, Spero Therapeutics Inc.
Music: .. .. .. .. .. ...
Music: ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music
[music].