Earnings Call Transcript - SPRO Q2 2020

Operator, Operator

Greetings, and welcome to the Spero Therapeutics Second Quarter 2020 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Sharon Klahre. Thank you. You may begin.

Sharon Klahre, Host

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 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 contain 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 the 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. Participating in today’s call from Spero are Dr. Ankit Mahadevia, Chief Executive Officer; Dr. David Melnick, Chief Medical Officer; Cristina 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.

Ankit Mahadevia, CEO

Thank you, Sharon, and good afternoon, everyone. We appreciate you joining us today. Spero continues to make significant progress in advancing its pipeline. We are pleased to announce that we remain on track to report top line data from our Phase III trial for tebipenem HBr in complicated urinary tract infections called ADAPT-PO in the third quarter. The ADAPT-PO trial is a head-to-head evaluation of oral tebipenem versus IV ertapenem, and it’s designed to give physicians the confidence to prescribe tebipenem HBr based on robust evidence of its positive patient outcomes. 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 I trials that we are completing, will enable us to file for regulatory approval of tebipenem HBr for cUTI in the U.S. which, if approved, will facilitate our evolution to a commercial stage company. While I’ll leave it to Dr. Melnick to give more detail on our ADAPT-PO trial and our broader pipeline progress, 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 have allowed us to effectively navigate these challenges and remain on track to deliver data for ADAPT-PO within our third quarter 2020 guidance, our ongoing assessment of the situation suggests an impact to certain future timelines. Specifically, we now expect to begin a rolling submission of a tebipenem HBr new drug application to the FDA in the first quarter of 2021, pending positive Phase III data and the FDA’s agreement, with the completion of 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 to clinical research organization and clinical trial site capacity, we now plan to initiate a Phase I bronchoalveolar lavage clinical trial assessing the penetration of SPR206 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 medicines. 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. Further, 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. Oral 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. The role of antibiotics in this strategy is a major focus of governments around the world, and recently we’ve seen large pharmaceutical companies increasing their long-term commitment to this area, such as with the recent announcement of the AMR Action Fund. 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 DTRA, as well as from our relationships with corporate partners. On the financial front, we ended the second quarter with $71.4 million in cash, which takes us into the first quarter of 2021 beyond the ADAPT-PO top line data announcement this quarter and the expected initiation of our SPR720 Phase IIa clinical trial in the second half of 2020. 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.

David Melnick, CMO

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, tebipenem HBr, an oral carbapenem that is currently being evaluated in our ADAPT-PO Phase III clinical trial. ADAPT-PO is a noninferiority trial comparing oral tebipenem head-to-head versus intravenously administered ertapenem, the carbapenem that is most commonly used for complicated UTI. The trial has completed enrollment of 1,372 patients in May, and all patient follow-up is now complete. Trial participants were randomized on a 1:1 basis and received either oral tebipenem or IV ertapenem for seven to 10 days. The primary endpoint of the trial is overall clinical and microbiologic response, and that 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 the ADAPT-PO 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. As this relates to the tebipenem NDA submission, we expect this reduced CRO capacity to impact the Phase I trials that are required for NDA submission. Therefore, we now anticipate initiating a rolling NDA submission to the FDA for tebipenem HBr in 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- and cephalosporin-resistant enterobacteriaceae continue to rise in both the hospital and community settings, and this severely limits the activity of the currently available oral antibiotics. ADAPT-PO does not include an IV lead-in for the oral tebipenem arm, which is important because it will build the confidence of physicians to prescribe an oral antibiotic for complicated UTI as a replacement for IV therapy. Several recent clinical studies have demonstrated that the 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 tebipenem, combined with extensive pharmacokinetic and pharmacodynamic data derived from our Phase I 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 II data generated by our Japanese partner, Meiji Seika, and an interim PK read in the ADAPT-PO trial that confirmed the PK/PD models supporting tebipenem HBr dosing. I would also highlight that tebipenem in powder form has been marketed in Japan for over 10 years, giving us a significant safety database to add to the body of knowledge on this molecule. Moving on from 994 or tebipenem to SPR720, our oral drug candidate for the treatment of nontuberculous mycobacterial or NTM infections. We previously announced Phase I data in healthy patients demonstrating that repeated doses of 1,000 milligrams administered once daily were safe and well tolerated, which we believe will 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 IIa trial is the appropriate next step in development. Longer term, the development of SPR720 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 SPR720, 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 a monotherapy in NTM patients who are treatment-inexperienced. 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, an outcome that, if positive, will highlight the activity of SPR720 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 SPR206, our IV next-generation polymyxin agent 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 Medicines. We are advancing SPR206 based on previous Phase I data that demonstrated the drug was well tolerated at a dose of 300 milligrams 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. The absence of nephrotoxicity at or above the predictive therapeutic dose clearly differentiates SPR206 from earlier generation polymyxins. We announced in our press release that we are delaying the initiation of our Phase I bronchoalveolar lavage, or 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 SPR206 in 2021. I will now turn the call over to Cristina Larkin, our Chief Operating Officer, who will provide you with a review of the market opportunity for our pipeline products.

Cristina Larkin, COO

Thank you, David, and good afternoon, everyone. While the development teams have been really hard at work on our Phase III and NDA planning, the commercial and medical affairs teams have been interacting with our future customers, including providers and payers, as we prepare tebipenem HBr to 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. 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 therapies. And 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 fluoroquinolone, 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%. It is really our estimation that over two million patients a year would benefit from the convenience of a new oral therapy for cUTI. Our interactions to date with some of our key customers have further highlighted that tebipenem HBr has the potential to benefit all of our stakeholders, including health care providers, payers, and importantly, our patients. Health care 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. 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 to prevent unnecessary hospitalizations. This is more important than ever in the era of COVID as hospitals are already at reduced capacity and are really preserving these beds for the seriously ill. Further, payers do see the benefits of covering an oral alternative for cUTI 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 tebipenem HBr will be primarily reimbursed in the retail sector and paid as a pharmacy benefit and not under that hospital DRG. The benefits of a new oral therapy to potentially treat the growing number of patients facing resistant infections, coupled with the limitations of IV treatments in the outpatient setting, provide this great value foundation for the commercial launch of tebipenem HBr that, if approved, really 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.

Steve DiPalma, Interim CFO

Thank you, Cristina. Good afternoon, everyone. 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 on Spero’s contract with Biomedical Advanced Research and Development Authority for qualified tebipenem HBr expenses was slightly higher in the second quarter of 2020 compared to the same period in 2019. However, this increase was offset by a decrease in SPR206 funding from the U.S. National Institute of Allergy and Infectious Diseases. As a reminder, BARDA has committed to provide a total of nondilutive funding 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 have a second option for $12.7 million in additional nondilutive funding that remains exercisable by BARDA. For 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 tebipenem HBr program. Research and development expenses declined quarter-over-quarter this year due to 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 greater expenses associated with progressing our pipeline candidates. In the second half of 2020, we expect to recognize research and development expenses associated with tebipenem HBr Phase I clinical trials and ADAPT-PO clinical trial wind down as well as SPR720 Phase IIa 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 tebipenem HBr through potential regulatory approval as well as support Spero’s other product candidates. Our net loss for the second quarter ended 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. The increase was largely attributable to greater clinical development activity. As of June 30, 2020, Spero had cash and cash equivalents of $71.4 million. We believe that our existing cash, cash equivalents and marketable securities, together with committed funding from the BARDA contract and other nondilutive funding commitments, will be sufficient to fund our operations into the first quarter of 2021. For further details on our financials, including comparisons of the quarters ended June 30, 2020, and June 30, 2019, please refer to our 10-Q filed with the SEC today. We’d now like to open the call for questions. Operator?

Operator, Operator

[Operator Instructions] Our first question is from Ritu Baral from Cowen. Please proceed with your questions.

Ritu Baral, Analyst

Hi, guys, thanks for taking the question. I’ve got a couple. The first one is, can you list for us the outstanding tebipenem Phase I studies needed if Phase I is needed for the NDA submission? And also as a follow-up, can you take us through your most current thoughts on potential pricing?

Ankit Mahadevia, CEO

Thanks, Ritu, for the question, and it’s nice to hear from you. I will take the first question, and I will pass the second question on pricing to Cristina. So as it relates to our ongoing Phase I 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 I 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 to the second question – go ahead please, Ritu.

Ritu Baral, Analyst

The pricing question, yes.

Ankit Mahadevia, CEO

And that I’ll pass to Cristina.

Cristina Larkin, COO

Thanks, Ankit. I think you know, Ritu, we haven’t really spoken about the 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 insights into some of the work that we’ve done so far that guides us to how our payers are thinking about pricing. They’re looking at the adjudication of how to think about pricing for us considering what we’re relieving them in medical expense or cost of either outpatient IV therapy or the prevention of hospitalization, so that’s really good news that we have that further guidance from the payers. Through some of the initial data work, what we’ve seen is that the treatment cost could be as high as about $5,000 for treatment cost in the highest range of their pricing model. So it does give us some level of flexibility to think about pricing around $5,000 per course of treatment, not per day, just to give you some idea. I think in our corporate deck, we used $350 as a placeholder price per day, given that’s where some of the branded Gram-positive agents have landed.

Ritu Baral, Analyst

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 the Phase II and when we might see data from that study?

Ankit Mahadevia, CEO

Thanks for the questions. So that is 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 will 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.

David Melnick, CMO

Yes. 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 cultures. So it will be change in sputum bacterial burden over time.

Ritu Baral, Analyst

Great. Thanks.

Operator, Operator

The next question is from Louise Chen with Cantor. Please proceed with your question.

Louise Chen, Analyst

Hi, thanks for taking my questions here. 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 actually 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?

Ankit Mahadevia, CEO

Thanks, Louise, for the questions, we appreciate it. To the first part of your question, as we noted, given the obvious impact that infection has had on every aspect of our life, there certainly is quite a bit of heightened focus from governments around the world in terms of preventing and defending against the next infection. We’ve seen BARDA take a prominent role in planning ahead for the nation’s defense, both against the coronavirus but also bacterial threats. Even prior to COVID-19, we’ve seen an example of a comprehensive stockpile agreement, and we would expect that that will continue based on federal funding trends. We’re pleased to have a development relationship with BARDA that allows us to demonstrate not only what the medicine can do for patients suffering from complicated urinary tract infections but also downstream demonstrate the potential utility of this agent in addressing other microbial defense threats that are BARDA’s focus. On the second point, looking ahead, we take a stepwise approach to building the company. We want to deliver this quarter on the ADAPT-PO trial to note what this medicine can do. Going forward from there toward NDA, we will take a stepwise approach that is capital efficient and prudent. We won’t have to bring on a large sales force in the near term. On the third question, there’s a macro question that has fundamentally driven Spero’s pipeline. It’s our belief that successful and sustainable antibiotics have two primary components: the first is true unmet need, indicated by a population with a high prevalence of infection today, and the second is the absence of alternative generic therapies. In our case with tebipenem, there are no alternative generic or branded therapies to meet the need. The second component addresses where we deliver these medicines to patients. We believe that delivering medicines outside of the hospital setting and away from hospital DRGs is key to successful launches, whether they are recent, such as Arikayce, or more historical.

Louise Chen, Analyst

Thank you.

Operator, Operator

Our next question is from Stephen Willey, Stifel. Please proceed with your question.

Stephen Willey, Analyst

Yes. Thanks for taking the question. Looking forward to the data later this quarter. Can you maybe just speak to a little bit about how the extension on the NDA filing impacts the pace of commercial build-out and just kind of payer and 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 IIa. What are your thoughts just around 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 just curious if you have any thoughts as to how you would like to see that improved.

Ankit Mahadevia, CEO

Thanks, Steve, for the questions. We appreciate it. To your first question, the way we think about delivering tebipenem to patients is in two parts. The first part, as Cristina mentioned, is engaging our customers, including patients, physicians, and payers. Early and often, to communicate the incredible demand we’ve heard from them for an effective oral agent for complicated UTI. It’s important for us to continue to engage with these customers and develop the market for tebipenem now going forward, even beyond an NDA filing and potential acceptance. This engagement will continue at its current pace and, in the case of successful ADAPT-PO results, will certainly accelerate. The second component of getting tebipenem to our patients is building the infrastructure to deliver tebipenem once approved. As you might imagine, that portion is geared toward our PDUFA date and how we temporize that buildup. What we’ve heard is really exciting and positive regarding the unmet need for an oral carbapenem. Regarding your second question on SPR720, we’ve been pleased to discuss with the FDA in prior press releases about our development strategy for SPR720. We see the opportunity for a clinical and patient-reported outcome to facilitate quicker readouts and in a way that aligns with how physicians and patients perceive NTM. The evolution with NTM means it's more important, as we’ve learned from the FDA Adcom, to demonstrate that a patient feels better and can manage the disease, rather than simply clearing the microbiology. The paradigm change mirrors what we’ve seen with HIV in the past, where long-term disease management is prioritized over disease eradication. We are taking a stepwise approach to the development of the PRO and will leverage insights from our ongoing Phase II study as well as continual discussions with the patient and physician community.

Stephen Willey, Analyst

Okay. That’s helpful. And then maybe just a quick follow-up on the 720 front. Presumably, if the Phase IIa trial goes well or as planned, the next study would involve a longer treatment duration. Can you just remind us what your current toxicology package allows you in terms of coverage? And is that preclinical data something you would generate in parallel to the Phase IIa so that the transition time into the longer duration study wouldn’t necessarily be constrained by the need for greater toxicology coverage?

Ankit Mahadevia, CEO

Yes, thanks for that great question, Steve. I want to note that both in our primate and other species toxicology data, as well as our Phase I studies, we’ve been pleased to find our compound to be very safe and well tolerated, and we’re excited to demonstrate what it can do in a patient study in Phase II. To your specific question, we’ll focus on understanding longer-term exposures for SPR720, allowing us to drive the Phase IIb study in a timely manner.

Ram Selvaraju, Analyst

Thanks very much for taking my questions. I was wondering if you could just verify for me. I believe 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, CEO

Thanks, Ram. Credit to our team, the short answer is no. We’re confident about the data set we’ll deliver this quarter.

Ram Selvaraju, Analyst

Fantastic. And then secondly, I was wondering if you could talk a little bit about the scenario analysis you’ve been running internally regarding the kind of market environment you might have to negotiate in introducing tebipenem HBr. Do you think the COVID-19 situation is going to be different months from now or six months from now? I don’t think anybody can really predict for sure. But maybe you can talk through a few scenarios that you’re modeling and how you intend to potentially overcome some of the challenges that might arise as you execute your commercialization strategy.

Ankit Mahadevia, CEO

Thanks for the question, Ram. I’ll pass that one over to Cristina.

Cristina Larkin, COO

Yes. Thank you, Ram. Yes, we’ve been closely monitoring what other companies have been doing facing this pandemic with access into clinicians’ offices. I think the one great thing that we’ve had the opportunity to do is learn from what’s been ongoing in the marketplace. It seems that doctor’s offices are opening up across the country, which signals positive access to clinicians. Simultaneous and parallel to that process, we’ve been developing a solid digital strategy, and that's part of what we’re pursuing. We have seen and followed the literature about how physicians are utilizing digital means and contacting the company. These are some scenarios we are actively exploring and monitoring to ensure we can remain successful.

Ram Selvaraju, Analyst

Okay. Great. And then lastly, it was just a general question regarding your pipeline of innovative antibiotics. We’ve seen developments occurring within the context of big pharma regarding alternative funding mechanisms for novel antibiotics. Can you discuss how that picture has changed and how it might be relevant to your development-stage programs and the perspective on this issue going forward?

Ankit Mahadevia, CEO

Yes. Thanks for the question, Ram. I’ll divide my response. First, I want to emphasize that our philosophy has always been to develop medicines in market opportunities that are sizable and sustainable, even without extra incentives. That said, we have observed significant trends, both in the U.S. and Europe, to create robust incentives for antimicrobial development, including the AMR Action Fund that pledged $1 billion for antimicrobial investment and development unveiled in the second quarter. We welcome this initiative, and pipeline medicines such as SPR206 and others will be excellent candidates for that fund and similar programs. Overall, we’re encouraged by this development as it provides additional opportunities for Spero, but I want to reiterate that we’ve intentionally chosen our pipeline medicines and target markets to ensure our success, regardless of external factors.

Operator, Operator

[Operator Instructions] Our next question is with Jason Gerberry with Bank of America. Please proceed with your question.

Chi Fong, Analyst

Hi, good afternoon. This is Chi on for Jason. Thanks for taking my questions. A few if I may. Can you elaborate what would the clinical package of the NDA entail? And second would be, do you have a spot with the FDA that a single Phase III can support approval? You talked about earlier on the call about your Phase I studies and mentioned three: the structural, interaction, renal. It looks like those may be focusing more on the safety side. Can you talk about the Phase I bioequivalence? What are you trying to achieve? It seems you’ve already done some studies showing PK data of the oral versus the IV, so it does seem you’d be doing that.

Ankit Mahadevia, CEO

Yes. Thanks for the questions. I appreciate it. To your first question, regarding the NDA clinical package, as I mentioned, not all studies published in clinicaltrials.gov are mandatory for the NDA process. The Phase I studies that are ongoing include the bioequivalence study and the drug-drug interaction study that David referred to in a prior call and a study focused on renally impaired patients. Regarding the second question, we did confirm in public interactions with the FDA that the ADAPT-PO trial is the pivotal trial necessary for FDA approval for the treatment of complicated urinary tract infections. If you infer from the studies, the primary focus of the bioequivalence study is to indicate that some adjustments we’ve made to the commercial supply of tebipenem align with the clinical supply.

Chi Fong, Analyst

And is the formulation being used in Phase III the same or different than the final commercial embodiment?

Ankit Mahadevia, CEO

No. As I indicated, and as is common, we’ll make some minor modifications, including the visual presentation of the tablet when moving to commercial.

Chi Fong, Analyst

Okay. Thank you.

Operator, Operator

It appears there are no further questions at this time. I would like to turn the floor back over to management for concluding comments.

Ankit Mahadevia, CEO

Thank you, operator. As you can probably tell, we are excited about the prospects for our drug candidates, and we’re looking forward to reporting tebipenem HBr Phase III data this quarter. I invite everyone to join us at our next webcast presentation at the Cantor Virtual Healthcare Conference beginning on September 15. I wish everyone a very happy and safe summer. Thank you very much.

Operator, Operator

This concludes today’s conference. Thank you for your participation. You may disconnect your lines at this time.