Q1 2021 Spero Therapeutics Inc Earnings Call

[music].

Operator: Sparotherapeutics' first quarter 2021 earnings call. At this time, all participants are in a listen-only mode.

Greetings and welcome to Spero Therapeutics first quarter 2021 earnings call.

At this time all participants are in a listen only mode.

Operator: My question and 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. I would now like to turn the conference over to your host, Ashley Robinson of Investor Relations. Thanks, Joe, and thank you all for participating in today's conference call. Earlier today, Sparatheraetics released financial results and provided a pipeline update for the first quarter of 2021.

And the answer session will follow the formal presentation.

Once you require operator assistance during the conference. Please press star zero on yourself on keep that as a reminder of this conference is being recorded.

I would now like to turn the conference over to your host Ashley Robinson of Investor Relations.

Thanks, Joe.

Thank you all for participating in today's conference call earlier today, Spero Therapeutics released financial results and provided of pipeline update for the first quarter of 2021, if you have not yet seen the press release. It is available on the investors page of the Spero Therapeutics website.

Operator: If you have not yet seen the press release, it is available on the investors page of the Sparotherapeutics website. Before we begin, I would 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, including statements about the initiation, timing, and submission to the FDA of an NDA for Tebupanm-HBR and the potential approval of Tebupanm-HBR by the FDA.

Before we begin I would 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, including statements about the initiation timing and submission to the FDA of an NDA for <unk> 10 of them H B R and the potential approval of <unk> 10 of them H B R by the FDA future.

Operator: Future commercialization, the potential number of patients who could be treated by Tebupenum-HBR, and the market demand for Tebupanum-HBR generally. expected broad access across payer channels for TevipanMHBR, the expected pricing of TevipanMHBR, and the anticipated shift in treating patients from intravenous to oral administrations. The plans for the company's ongoing development of SPR 720, the design, initiation, timing, progress, and results of the company's pre-clinical studies and clinical trials and its research and development programs, management's assessment of the results of such pre-clinical studies and the clinical trials, the impact of the COVID-19 pandemic on the company's business and operations, and the company's cash forecast and anticipated expenses and the sufficie Such forward-looking statements are not guarantees of performance, and the company's actual results could differ materially from those contained in such statements.

Commercialization of potential number of patients who could be treated by some of your kind of of H B R and the market demand for it have you been image be are generally ex.

<unk> brought access across payer channels, but can you kind of of H B R. The expected pricing of study of Panama, H B R and the anticipated shift in treating patients from intravenous to oral administration.

Plans for the company's ongoing development of Spi 2020, the design initiation timing progress and results of the company's preclinical studies and clinical trials and its research and development of programs management's assessment of the results of such preclinical studies on the clinical trials the impact of the COVID-19 pandemic.

On the company's business and operations and the company's cash forecast and anticipated expenses and the sufficiency of its cash resources.

Such forward looking statements are not a guarantee of performance on the company's actual results could differ materially from those contained in such statements.

Ashley Robinson: Several factors that could cause or contribute to such differences are described in detail in the filings that the company filed with the SEC, including the risk factors section of our quarterly report on Form 10Q, which was filed today. These forward-looking statements speak only as of the date of this conference call, and the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the company after the date of today's release and call.

Factors that could cause or contribute to such differences are described in detail in the filings that the company has filed with the SEC, including the risk factors section of our quarterly report on form 10-Q, which was filed today.

These forward looking statements speak only as of the date of this conference call on the company undertakes no obligation to publicly update any forward looking statements or supply new information regarding the company. After the date of todays release and call.

Ashley Robinson: Participating in today's call from Sparrow or Dr. Ankit Mahadeviya, Chief Executive Officer, Dr. David Milnick, Chief Medical Officer, Christina Larkin, Chief Operating Officer, and Sass Chukla, Chief Financial Officer. With that, I'd like to turn the call over to Dr. Ankhut Mahadevia. Please go ahead.

Participating on today's call from Spero, our Doctor on Kitimat, Avs, Chief Executive Officer.

Dr. David Melnick, Chief Medical Officer, Cristina Larkin, Chief operating officer, and soft shoe Clark Chief Financial officer with that I'd like to turn the call over to Don Doctor I don't get my Dave Yeah. Please go ahead.

Ankit Mahadevia: Thank you, Ashley, and thanks to all listening for joining us to discuss our first quarter financial results and our corporate highlights. As we continue to progress through 2021, a major focus for Sparrow is the advancement of Tubby Penham HBR towards an NDA filing and the execution of our corporate strategy as we work to transition to a commercial organization. These efforts are supported by the positive phase three ADAPPO trial results, which we reported late last year.

Thank you Ashley and thanks to all listening for joining us to discuss our first quarter financial results and our corporate highlights.

We continued to progress through 2021, a major focus for spero is the advancement of Teddy kind of on H B R towards an NDA filing and the execution of our corporate strategy as we worked to transition to a commercial organization.

Efforts are supported by the positive phase III adapt P. O trial results, which we reported late last year. These results show that the trials primary endpoint was met with data demonstrating that an all oral regimen of 10 independent H B R is non inferior to an all IV regimen of ore dependent for the treatment of complicated journey.

Ankit Mahadevia: These results show that the trial's primary endpoint was met, but Dave demonstrated that an all-oral regimen of pebipenum HBR is not inferior to an all-I-B-Regenergrament of urtipenum for the treatment of complicated urinary tract infection, or CUTI, an acute pylophritis, or acute, Previous FDA interactions and written communication indicated that positive results from single well-controlled pivotal trials such Today, I'm pleased to report that we recently completed a pre-NDA meeting with the agency and received feedback that was consistent with all of these prior interactions. The FDA has endorsed the structure and form of our planned NDA submission and indicated that the clinical data set and CMC plan that we intend to submit in the NDA package meet their standards.

Infection or C. A T I and acute pyelonephritis or AP.

Our previous FDA interactions and written communication, indicating the positive results from the single well controlled pivotal trials, such as adapt Po could be sufficient to support the approval of a new drug application or NDA for <unk> depend on H b on the treatment of C U T on AP.

Today I'm pleased to report that we recently completed a pre NDA meeting with the agency and receive feedback that was consistent with all of these prior interactions on the FDA has endorsed the structure and form of our planned NDA submission and indicated that the clinical data set and CMC plan that we intend to submit in.

The NDA package to meet their standards. This positive regulatory interaction together with the fact that all of the data we need per submission is in our hands keeps us on track to complete the turbine pen on H B, our NDA submission in the second half of the year as we previously guided.

Ankit Mahadevia: This positive regulatory interaction, together with the fact that all of the data we need for submission is in our hands, keep us on track to complete the Tabipenum HBR NDA submission in the second half of the year as we previously guided. Now, in addition to supporting the NDA filing, another important goal of the ADAPTO trial was to answer the fundamental question that physicians and payers have regarding an oral version of a powerful IV medicine.

Now in addition to supporting NDA filing another important goal of the adapt trial was to answer the fundamental question that physicians and payers have regarding an oral version of a powerful lobby medicine.

Ankit Mahadevia: And this question is, if patients are going to receive oral therapy in place of an IV option, how does the safety and efficacy of the oral agent compare to the IV? We address this question by designing ADAPPO as the first head-to-head comparison of an all-oral versus an all-I regimen in CUTI. Specifically, we did not include an IV lead in the oral tebipenum-hbri arm nor an oral step down in the IV-U-Tenem arm, as we wanted to provide physicians with direct evidence that would give them the confidence needed to prescribe TB-Pen-HBR to the millions of CUTI and AP patients who would otherwise receive IV therapy. As we have mentioned before, we believe we have done just that, as our data show that Tebipenum HBR can provide the convenience of an oral therapy without any compromises on clinical response, safety, or tolerability.

And this question is if patients are going to receive oral therapy in place of an IV option, how does the safety and efficacy of the oral agent compared to the IV.

We addressed this question by of that designing adapt Po is the first head to head comparison of an all oral versus an all IV regimen and senior tier.

Specifically, we did not include an IV the oral turbine kind of on H B R arm, north oral step down and the IV or depend on more as we wanted to provide physicians with direct evidence that would give them the confidence needed to prescribed to be pennant H E on to the millions of C. U T. I D P patients, who would otherwise receive IV therapy.

As we've mentioned before we believe we have done just that as our data show that <unk> 10 of H B R. Can provide convenience of an oral therapy without any compromises on clinical response safety or tolerability.

Ankit Mahadevia: Based on these compelling data, we believe Tebipen and HBR, if approved, would be an important treatment option for the over 2 million CUTI and AP patients in the US alone each year who are resistant to current available oral therapy. I should also point out that a potential approval would make Tebipenem the only oral carbopetam approved for treatment of CUTINAP and would provide patients who currently have no other options outside of IV therapies with a convenient alternative that could prevent and shorten unnecessary hospitalization.

And based on these compelling data, we believe <unk> pen on H B R. If approved would be an important treatment option for the over 2 million <unk> patients in the U S alone each year, who are resistant to current available oral therapies I should also point out that of potential approval would make turbine pet on the only oral carbon pad on approved for.

Treatment of C Upi and AP and we provide patients who currently have no other options outside of IV therapies with a convenient alternative that could prevent and shorten unnecessary hospitalizations.

Ankit Mahadevia: Moving on, I would now like to provide some updates on the SPSPR 720 clinical program. As we discussed in our last call, SPR 720 advanced into a phase 2A clinical trial in patients with non-tuberculous mycobacterial disease or NTM at the end of last year. The initiation of this trial was supported by positive data from phase one single and multiple ascending doses, as well as those trials, as well as non-clinical toxicology studies in non-human primates and rats.

Moving on I would now like to provide some updates on the troughs Pier 17, 20 clinical program.

As we discussed on our last call SPR of 720 advanced into a phase Iia clinical trial in patients with non tuberculosis mycobacteria of disease or N. P. M. At the end of last year. The initiation of this trial was supported by positive data from phase one single and multiple ascending doses as well are those trials as well as non clinical toxicology.

Studies in nonhuman primates interacts.

Ankit Mahadevia: Alongside the Phase 2A clinical trial, we were also conducting additional long-term toxicology studies of RAPS and adult non-human primates. In the non-human primate trial, we observed unexplained mortalities, which led us to pause the Phase 2A clinical trial while we conducted further analysis.

Alongside the Phase Iia clinical trial, we're also conducting additional long term toxicology studies in rats and adult non human primates in the non human primate trial, we observed unexplained mortality, which led us to pause the phase Iia clinical trial, while we conducted further analysis. We then promptly notified the FDA of our decision to pause.

Ankit Mahadevia: We then promptly notified the FDA of our decision to pause the trial and subsequently received notice of a clinical holding request by the agency for a study report from the non-human primate. I'm pleased to say that since our last earnings call, we have completed the non-human primate study. While we are currently analyzing the data and expect to submit the study report to the FDA in the third quarter, while we intend to wait until the FDA has had a chance to review the data and provide us with feedback before we share specific findings from our analyses, what I can say now is that the data we have seen to date supports the hypothesis that the observed mortality was dosing or species-specific rather than drug-related. And we'll continue our analysis to finalize that determination.

Chile, and subsequently received notice of a clinical hold on our request by the Agency Force study report from the non human Primate study.

I'm pleased to say that since our last earnings call. We have completed the non human Primate study. While we are currently analyzing the data and expect to submit the study report to the FDA in the third quarter.

While we intend to wait until the F. D. A has had a chance to review the data and provide us with feedback before we share specific findings from our analyses what I can say now is that the data we have seen to date supports the hypothesis that the observed mortality, we're dosing or species species specific rather than drug related.

And we'll continue our analysis to finalize that determination.

Ankit Mahadevia: Based on this, we remain confident about SPR 720, and we will continue to engage the FDA on the path forward for the SPR 720 clinical program. Before handing off the call to David to provide some more detailed updates on our pipeline, I would like to acknowledge the talent and dedication of the Sparrow team and our partners, which allowed us to successfully execute on our strategy to manage our business amidst the ongoing COVID-19 pandemic.

Based on this we remain confident about SPR 720, and we will continue to engage the FDA on the path forward for the SPR of 720 clinical program.

Before handing off the call to David to provide some more detailed updates on our pipeline I would like to acknowledge the talent and dedication of the spero team and our partners, which allowed us to successfully execute on our strategy to manage our business amidst the ongoing COVID-19 pandemic, we continue to benefit from the investments in information technology, we made.

Early on that enable a fully remote workforce and notably of not seen any material impacts from the pandemic on our business thus far in 2021.

Ankit Mahadevia: We continue to benefit from the investments in information technology we made early on that enable a fully remote workforce and, notably, have not seen any material impacts from the pandemic on our business thus far in 2021.

We've been successful in connecting with physicians digitally through our medical affairs efforts and we've been successful in hiring new talent to help lead of potential launch from <unk>.

Looking forward, we will continue to monitor from potential COVID-19 related impacts on our business and we will work diligently as we have to stay ahead of them.

Ankit Mahadevia: We've been successful in connecting with physicians digitally through our medical affairs efforts, and we've been successful in hiring new talent to help lead a potential launch for TEPA MHBR. Looking forward, we will continue to monitor for potential COVID-related impacts on our business and will work diligently as we have to stay ahead. Though COVID-19 hasn't materially impacted our business this year, it has had an impact on how physicians deliver medicines to their patients.

The COVID-19 hasn't materially impacted our business. This year. It has had an impact on how physicians deliver medicines for their patients.

Over the past 13, plus months the importance of treating patients in the community setting has been strongly emphasize which in turn is accelerating the trend of both physicians and patients seeking to prevent hospital admissions of possible.

Unfortunately, the increasing prevalence of resistance to existing oral therapies for cdti. Currently these millions of patients with no choice, but to be treated with IV therapy, often within the hospital.

Ankit Mahadevia: Over the past 13-plus months, the importance of treating patients in the community setting has been strongly emphasized, which in turn is accelerating the trend of both physicians and patients seeking to prevent hospital admissions if possible. Unfortunately, the increasing prevalence of resistance to existing oral therapies for CUTI currently leaves millions of patients with no choice but to be treated with IV therapy often within the hospital. Our conversations with physicians have indicated that if an effective oral option were available for these patients, they would prefer to treat these patients outside of the hospital.

Our conversations with physicians have indicated that it's an effective oral option were available for these patients they would prefer to treat these patients outside of the hospital. This would reduce patient exposure to COVID-19, and other secondary infections offer of financial benefits of the hospital and free up capacity for ill patients with no viable alternatives.

Two of hospitalization.

If approved we believe to be permanent H B R could offer physicians would such an auction. This in turn would address of critical unmet need that has been exacerbated by the pandemic by enabling a shift to the outpatient setting.

None of it is also highlighted the need for a more comprehensive approach to develop medicines to address current and future infectious threats. We're thrilled with the biotech community has joined with policymakers and government agencies, along with major pharmaceutical companies as we develop innovative solutions to the current and future threats, we face we.

Ankit Mahadevia: This would reduce patient exposure to COVID-19 and other secondary infections, offer a financial benefit to the hospital, and free up capacity for ill patients with no viable alternatives to hospitalization. If approved, we believe Tebby MNHBR could offer physicians such an option. This, in turn, would address a critical unmet need that has been exacerbated by the pandemic by enabling a shift to the outpatient system.

We remain active in these collaborative efforts as shown by our previously discussed partnerships with several agencies, including BARDA out of U S Department of defense and detail as well as our relationships with corporate partners and private foundations. Additionally, we recently entered into a new partnership with the National Institutes of allergy and in fact.

Ankit Mahadevia: The pandemic has also highlighted the need for a more comprehensive approach to develop medicines to address current and future infectious threats. We're thrilled that the biotech community is joined with policymakers and government agencies, along with major pharmaceutical companies, as we develop innovative solutions to the current and future threats we face. We remain active in these collaborative efforts, as shown by our previously discussed partnerships with several agencies, including Barta, the U.S. Department of Defense, and DETRA, as well as our relationships with corporate partners and private foundations.

These diseases or N E I D, which we will discuss further in a few minutes as it relates to supporting our ambitious plans to generate additional data on the utility of <unk> 10 of them.

With that I will now hand, it over to David to provide a more detailed update on our clinical progress in our pipeline.

Thank you on kit, it's great pleasure to share our pipeline updates today.

I'll begin with our lead candidate of <unk> kind of each viewer.

Ankit Mahadevia: Additionally, we recently entered into a new partnership with the National Institutes of Allergy and Infectious Diseases, or NIAID, which we will discuss further in a few minutes as it relates to supporting our ambitious plans to generate additional data on the utility of Tempe Penna. With that, I will now hand it over to David to provide a more detailed update on our clinical progress and our pipeline. Thank you, Ankit.

All part of a tenant that's advancing towards an NDA filing that is expected in the second half of the year.

This NDA will be supported by the positive phase III data from the adapt trial. The trial met its primary endpoint by demonstrating that oral tablet kind of MAGE <unk> is non inferior to on the rig count in the treatment of patients with complicated urinary tract infections, including a pawn loans.

David Milnick: It's a great pleasure to share our pipeline updates today. I'll begin with a lead candidate, Tebupenum HBR, an oral carbitanum that's advancing towards an NDA filing that is expected in the second half of the year. This NDA will be supported by positive phase three data from the ADAPT trial. The trial met its primary endpoint by demonstrating that oral tebipenum HBR is non-inferior to IV urtipanum in the treatment of patients with complicated urinary tract infections, including acute pylenophydritis.

Projects to provide a brief recap of these data we saw overall combined clinical and microbiological response rates of 58, 8% for oral could be pounds of 61 six per cent for IV, <unk>, which met the pre specified non inferiority margin.

12, 5% together with other adapt Po down of these results show that both clinical cure and microbiological eradication rates were comparable between the oral and IV treatment groups at the end of treatment the test of cure and late follow up visits importantly.

David Milnick: To provide a brief recap of these data, we saw overall combined clinical and microbiologic response rates of 58.8% for Oropepenum and 61.6% for ibupinem, which met the pre-specified non-inferiority margin of 12.5%. Together with other ADAPPO data, these results show that both clinical cure and microbiological eradication rates were compromised. between the oral and IV treatment groups at the end of treatment, the test of cure, and at late follow-up visits. With respect to Clostridium difficile infection, no cases were observed in the oral Tabipenum HBR arm, while three cases were observed in the intravenous Erdoganaman.

Adapt Po also demonstrated the oral type of kind of HCR has of safety and Tolerability profile that is comparable to net of IV or depending on the.

<unk> been frequency of adverse events observed were well balanced across groups with treatment emergent adverse events reported in 26% of patients in both arms. The most common treatment emergent adverse events of diarrhea and finish of occurred with similar frequency in both groups with respect to cost.

Trillium difficile infection, no cases were observed in the oral can be kind of on H B R. On well three cases were observed in the intravenous route of kind of more Unfortunately, no deaths were reported across the study.

David Milnick: Fortunately, no deaths were reported across the study. In addition to this robust phase three data set, we now have in hand all of the data from the supporting phase one studies that will be incorporated in the NDA. As discussed by Ombit, we recently completed a pre-NDA meeting with FDA and received feedback indicating that the format and content of the planned data package that we intend to include in the NDA will be sufficient to support the submission. This keeps us on track to start.

In addition to this robust phase II data set we now have on hand, all of the data from the supporting Phase one studies that will be incorporated in the NDA.

As discussed by on Kit, we recently compete completed a pre NDA meeting with FDA and received feedback, indicating the format and content of the planned data package that we intend to include in the NDA will be sufficient to support the submission. This keeps us on track to submit the NDA.

David Milnick: submit the NDA in the second half of this year. In parallel with our efforts regarding the NDA, we also continue to work with our partners to ramp up our CMC capabilities ahead of Tebipem's expected launch in 2022. I should remind everyone that one of these partners is Meiji Seika, whose experience manufacturing a granular formulation of Tebipenum over the past decade will be invaluable as we move forward towards commercialization.

In the second half of this year.

In parallel with our efforts regarding the NDA. We also continue to work with our partners to ramp up our CMC capabilities ahead of Tami tenants expected launch in 2022, I should remind everyone that one of these partners partners is a major center, whose experience manufacturing.

<unk> granular formulation of <unk> kind of over the past decade will be invaluable as we move forward towards commercialization.

David Milnick: I would like to take a moment to talk about what we believe the ADAP PO data will mean from a physician's perspective. I'll start by talking specifically about the treatment of complicated UTIs, but I'd also briefly mention the strong external interest of key opinion leaders for the use of TEPA PEMR to treat other infections, providing potential opportunities to explore new indications. With respect to complicated UTI, treatment options have become increasingly limited by antibiotic resistance, as well as safety concerns around existing oral antibiotics, including fluoroquinoes. This often leads to hospitalization of patients for intravenous antibiotic therapy.

I would like to take a moment to talk about what we believe the adapt Po data will mean from a physician's perspective.

Part of our talking specifically.

About the treatment of complicated UTI, but I'd like to also briefly mentioned the strong external interest of key opinion leaders for the use of <unk> 10 on each VR to treat other infections, providing potential opportunities to explore new indications with respect to complicated UTI true.

On options have become increasingly limited by antibiotic resistance as well as the safety concerns around the existing oral antibiotics, including the Fluoroquinolones. This often leads to hospitalization of patients for intravenous antibiotic therapy, we specifically designed to GAAP PR is a head to.

David Milnick: We specifically designed DAPO as a head-to-head comparison of an all-oral and all-I-V antibiotic regimen to provide physicians with robust data that would give them the confidence to replace hospital IV therapies with oral Tebepenem-HBR. We believe that we've accomplished this goal, as we have shown that Tebepi-Penum-HBR can provide the convenience of an oral therapy without making compromises in terms of clinical response, safety, or tolerability. From a broader perspective, we are excited to report that as we have executed on their medical affairs strategy, we have seen strong external interest in the clinical utility of Tabipanum HBR as an alternative to intravenous antibiotic therapy for infections other than UTI. One example is a study designed to compare early transition to oral tebipenum HBR versus continued intravenous carbapenum therapy in patients with bloodstream infections caused by ESBL-producing bacteria.

The head comparison of the <unk>.

All of oral and all of IV antibiotic regimen to provide physicians with the robust data that would give them the confidence to replace hospital IV therapies with or have you kind of make VR. We believe that we've accomplished this goal as we have shown that can be kind of <unk> can provide the convenience of it.

Oral therapy without meeting, making compromises in terms of clinical response safety or tolerability.

From a broader perspective, we are excited to report that Ashley of executed on their medical affair strategy. We have seen strong external interest in the clinical utility of <unk> 10 of HB or as an alternative to intravenous antibiotic therapy for infections other than UTI.

Hi.

One example is of study designed to compare early transition to oral <unk> H B R versus continued intravenous <unk> therapy in patients with blood stream infections caused by <unk> producing bacteria.

David Milnick: This trial, entitled Marino 4, is being sponsored by the National Institute of Allergy and Infectious Diseases, and the trial is being conducted by the Antibiotic Resistance Leadership Group, or ARLG. The decision by ARLG and NIAID to sponsor and deliver this innovative study provides important external validation for TEPIPIPHBR's potential to address a critical unmet need and get patients suffering from a variety of infections home from the hospital sooner. In addition, the Phase 1 Bronco Alveola Lavage trial, assessing the lung penetration of Tabipenum HBR, that we started in December has now completed dosing, and data analysis is in progress. This important study is funded by Barta and will set the stage for subsequent Barta-funded studies to evaluate the efficacy of orally administered Tebepenum HBR for mnemonic indication.

This trial entitled Marino for is being sponsored by the National Institute of balance sheet infectious diseases and the trial is being conducted by the antibiotic resistance leadership group or a O L. G.

The decision of our LNG and NIH to sponsor and deliver this innovative study provides important external validation for Kevin kind of of <unk> potential to address a critical unmet need and get patients suffering from a variety of infections home from the hospital.

Sooner.

In addition, the faithful and Bronco alveolar lavage trial assessing the lung penetration of <unk> that we started in December has now completed dosing and data analysis isn't progress. This important study is funded by BARDA and will set the stage for subsequent BARDA funds.

Good studies to evaluate the efficacy of orally administered can be found on H B R. From Pneumonic indications. This study has a strong clinical rationale.

David Milnick: The study has a strong clinical rationale as the granular formulation of Tebipenum is approved in Japan for several indications, including the treatment of children with pneumonia. Looking forward, we plan on continuing to educate the clinical community on the benefits of Tebipenum HBR through publication of a peer-reviewed manuscript reporting the ADAPT trial results in detail. Additionally, we plan to have a presence at four infectious diseases and urology conferences this year, where we will present additional ADAPPO data, as well as indigent surveillance data, assessing the activity of Tabipenum HBR against prevalent gram-negative pathogens.

The granule formulation of <unk> 10 of them is approved in Japan for several indications, including the treatment of children with pneumonia.

Looking forward, we plan on continuing to educate the clinical community on the benefits of Tempe town of H VR through publication of a peer reviewed manuscript reporting the adapt trial results in detail.

<unk>, we plan to have a presence at for infectious diseases and urology conferences this year.

We will present additional adapt P O data as well as in vitro surveillance data assessing the activity of <unk> against the prevalent Gram negative pathogens.

David Milnick: Moving on, I'd like to provide an update on SPR 720, our oral drug candidate in development for the treatment of NTM infection. Earlier this quarter, we announced that the FDA had issued a clinical hold on the phase-2a dose-ranging trial of SBR 720 in MTM pulmonary disease patients. This comes after we had notified the agency of our decision to pause this trial as a precautionary measure based on unexplained mortalities observed in a parallel ongoing toxicology study in adult non-human primates.

Moving on I'd like to provide an update on SPR 720, <unk>, our oral drug candidate in development for the treatment of MTM infections.

Earlier this quarter, we announced that the FDA had issued a clinical hold on the phase Iia dose ranging trial of SBR 720 in MTM pulmonary disease patients. This game. After we had notified the agency of our decision to pause this trial as a precautionary measure.

Based on unexplained mortality observed in a parallel ongoing toxicology study in adult non human primates and its clinical hold letter.

David Milnick: In its clinical hold letter, the FDA requested additional information from the non-human primate study, including a complete study report. Before moving on to discuss the developments we've seen in this program since our last call, I'd like to reiterate a few key points. First, the observed mortalities did not correlate with either the dose or the duration of SPR 720 drug exposure. Furthermore, adult non-human primates are well known to be very challenging to dose, which adds a level of complexity to the analysis.

The FDA requested additional information from the non human Primate study, including the complete study report.

Before moving on to discuss the developments we've seen in this program since our last call I'd like to reiterate a few key points first the observed mortality did not correlate with either of the dose with a duration of SPR 720 drug exposure.

Further adult non human primates are well known to be very challenging to dose, which adds a level of complexity to the analysis of <unk>.

David Milnick: Finally, the findings of this non-human primate study are contrary to what we have seen in prior pre-clinical and clinical studies of SPR 720. These prior studies include a single and multiple ascending dose phase one clinical study evaluating the safety, tolerability, and pharmacokinetics of orally administered SPR 720 in healthy adult volunteers. All participants completed the trial, and no serious adverse events were reported. Furthermore, we did not observe any remarkable findings in a series of non-clinical GLP toxicology and safety pharmacology studies of SPR 720, including IND-enabling 28 and 31-day GLP studies, both in non-human primates and rats. In addition, an ongoing form of toxicology study of SPR 720 in RANCE is currently ongoing and without untoward events

Finally, the findings of this non human Primate study are contrary to what we have seen in prior preclinical and clinical studies of SPR 720 of these.

Prior studies include of single and multiple ascending dose phase one clinical study evaluating the safety Tolerability and pharmacokinetics of orally administered SPR seven in healthy adult volunteers.

All participants completed the trial and no serious adverse events were reported.

Furthermore, we did not observe any remarkable findings in a series of non clinical GOP toxicology safety Pharmacology studies of SPR, seven 'twenty, including IMD, enabling 28, and 31 day GOP studies.

Both in non human primates and ramps in.

In addition, an ongoing form of toxicology study of SPR 720, and ramps is currently ongoing and without on toward events.

David Milnick: Since our last call in March, we have completed the non-human primate study in which we observed the unexplained mortalities. We're currently analyzing these data and preparing the study report, but we do not plan to share specific findings until the FDA has had a chance to review the results and provide feedback. Any determination of the cause of the mortality, including whether it is related to the manner of drug administration via oral gavage, the species or age of the monkeys utilized for the study, or if this is a pharmacological effect will follow a review of the complete data set from the study by both Sparrow and FDA.

Since our last call in March we have completed the non human primate study in which we observed the unexplained mortalities. We're currently analyzing these data and preparing the study report, but we do not plan to share specific findings until the FDA has had a chance to review the results and provide feedback.

Any determination as to the causes of mortality, including whether it is related to the manner of drug administration via oral gavage.

The species or age of the monkeys utilized for the study or if this is a pharmacological effect will final review of the complete data set from this study by both Spero and FDA.

David Milnick: However, what I can say now, and in fact, would like to emphasize for all of you listening now, is that based on the data we have seen today, we remain confident that there is a path forward for the SPR 720 clinical program. Along these lines, I would like to stress again that the decision we announced on our last call to discontinue the phase 2A clinical trial was not, I repeat, not indicative of our opinion regarding the ultimate success of this program.

However, what I can say now and in fact, we would like to emphasize for all of you listening now is that based on the data we've seen to date, we remain confident that there is a path forward for the STR seven eight clinical program.

Along these lines I would like to stress again that the decision we announced on our last call to discontinue the phase Iia clinical trial was not I repeat not indicative of our opinion regarding the ultimate success of this program is on Kate mentioned the data thus far support the hypothesis that the observed more.

David Milnick: As Ankit mentioned, the data thus far support the hypothesis that the observed mortalities were specific either to the oral gabarge dosing method or the species of monkey, rather than being related to an off-target pharmacologic effect. Thus, the decision to discontinue the trial was a strategic one.

Counties, where specific either to the oral dosing method, where the species of monkey rather than being related to an off target pharmacologic effect. The decision to discontinue the trial was a strategic one.

David Milnick: It allows us to avoid incurring costs from the trial while it is ongoing and may facilitate potential future adjustments to the phase two clinical study design following review with the FDA. Looking ahead, we anticipate submitting the study report from the completed non-human primate study to the FDA in the third quarter of 2021. After the agency has had the opportunity to review the data and provide feedback, we will provide an update on SPR 720 and our plans regarding its further clinical development.

Laos us to avoid incurring costs from the trial wallet is on the whole and may facilitate potential future adjustments to the phase II clinical study design following review with the FDA.

Looking ahead, we anticipate submitting the study report from the completed non human Primate study to the FDA in the third quarter of 2021. After the agency has had the opportunity to review the data and provide feedback we will provide an update on STR 700000, and our plans regard.

It's further clinical development.

David Milnick: Switching gears now to talk about SPR 206, our next generation IV polymixing agent that was developed as part of our potentiator platform. SPR 206 is clearly differentiated compared to the currently available polymix in antibiotics due to its lack of nephrotoxicity at or above the predicted therapeutic dose.

Switching gears now to talk about SPR two of six our next generation IV Polymyxin agent.

That was developed as part of our potentiate of platform.

<unk> six is clearly differentiated compared to the currently available polymyxin antibiotics due to its lack of nephrotoxicity at or above the predicted therapeutic dose. This is demonstrated by the phase one healthy volunteer data that we announced last year. These staff.

David Milnick: This was demonstrated by the Phase 1 Healthy Volunteer data that we announced last year. These data showed that the drug was well tolerated at a dose of 300 milligrams daily for 14 consecutive days with no clinically significant changes in laboratory tests, renal function, or severe or serious adverse events reported.

Out of showed that the drug was well tolerated at a dose of 300 milligrams of daily for 14 consecutive days with no clinically significant changes in laboratory tests renal function or severe or serious adverse events reported.

David Milnick: We believe that SPR 206 has the potential to address critical unmet medical needs, as it has potent activity against extensively drug-resistant bacterial strains, including pseudomonass, eruginosa, acinidobacter, bomaniae, and carbopanemase-producing Entrobacterialis, all of which are on the WHO priority pathogen list. Looking ahead, we continue to advance SPR 206 development with the support In the second quarter of the year, we expect to initiate a phase one bronchial alveola lavage clinical trial assessing the penetration of SPR 206 into the pulmonary compartment, as well as a renal impairment study.

We believe the SPR two of six has the potential to address critical unmet medical needs as it has potent activity against extensively drug resistant bacterial strains, including Pseudomonas aeruginosa, acinetobacter, <unk> and carpet panamax producing <unk> on.

All of which are on the who.

Priority pathogen list.

Looking ahead, we continue to advance SP SPR two of six development with the support of our partners at the Department of Defense and Everest medicines in the second quarter of the year, we expect to initiate a phase one bronchial alveolar lavage clinical trial assessing the penetration of the SPR too.

<unk> six into the pulmonary compartment as well as of renal impairment study.

David Milnick: The BAL study and renal impairment study are both important to SPR2O's sick patients, as they will guide usage of the medicine in our target patient population infected with MDR bacterial pathogens. As many of these patients suffer from lung infections, the BAL study will demonstrate the extent to which 206 penetrates lung tissue following dosing. The renal appearance study will guide dosing in the many patients with NDR infections that have reduced kidney function.

The all study in renal impairment study are both important to SPR two of six.

They will guide usage of the medicine in our target patient population.

Infected with MTR bacterial pathogens as many of these patients suffer from lung infections.

Ah study will demonstrate the extent to which two of six penetrates lung tissue following dosing.

The renal impairment study will guide dosing in the many patients with MTR infections that have reduced kidney function.

Christina Larkin: We expect to report data from the Bronco-Alvial Lavage and Menal Impairment Studies by early 2022. With that, I will now turn the call over to our chief operating officer, Christina Larkin, who will provide you with a review of the market opportunity for our pipeline products and detail our strategy for a potential launch of Tebipenum HBR.

We expect to report data from the Bronchoalveolar lavage from renal impairment studies by early 2022.

With that I will now turn the call over to our Chief operating Officer, Cristina Larkin, who will provide you with a review of the market opportunity for our pipeline products and detail our strategy for a potential launch of <unk> 10 on HB are.

Christina Larkin: Thank you, David, and good afternoon, everyone. Our commercial market access and medical affairs teams have been working hard to prepare for our anticipated launch. And we feel that we are well positioned for success based on the large market opportunity, our focused commercialization strategy, and the clinical and economic benefits that Tebipenimhvr can provide to both patients and payers for CETI and acute polytaphritis. We believe that TebipetMHBR addresses the largest opportunity in the antibiotic market today.

Christina.

Thank you David and good afternoon, everyone.

Our commercial market access and medical affairs teams have been working hard to prepare for our anticipated launch and we feel that we are well positioned for success based on the large market opportunity our focused commercialization strategy and the clinical and economic benefits of petty kind of HDR can provide to both patients and payers.

For cdti and acute pyelonephritis.

Christina Larkin: In fact, there are approximately 2 million patients in the U.S. that we believe are excellent targets for TebipenMHBR if it's approved. Now, our strategy is focused on the community setting and the hospital discharge setting. The community effort will initially focus on urology to keep patients out of the hospital who have failed previous oral antibiotic therapy or that are resistant to current oral therapy for CTI.

Christina Larkin: And in the hospital discharge market, our focus will be to help patients get out of the hospital sooner by giving health care providers the ability to discharge patients with CETI, an oral option that has demonstrated non-inferiority to the IVR-dependent. Now, this value story of potentially avoiding a hospitalization or reducing a hospital stay has resonated with our health care providers and payers in our conversations today. Now, regarding our strategy to reach these patients, we believe that a specially driven launch, focused on urologists and IDs, will allow us to capture a significant portion of this very large addressable market that I just discussed.

Christina Larkin: The strategy is supported by research showing that this target patient population is typically seen by specialists and tends to be concentrated, allowing us to have a very focused line. Now, as part of this research to inform our commercial efforts, we have interacted with more than 200 healthcare providers and payers, covering about 85% of the payer life cycle to better understand how Pebipenum HVR will fit into the CUTI treatment paradigm. And the feedback that we've received based on these interactions has indicated that if Tebipenim HBR is approved, there is strong interest from these healthcare providers to use it in both the community and the hospital discharge setting. And payers have indicated a strong willingness to cover Tebepa, and both healthcare providers and payers have indicated potential for value-based prices.

Sure, it's showing that this target patient population is typically seen by specialists and tends to be concentrated allowing us to have a very focused lodge.

Now as part of this research to inform our commercial efforts, we have interacted more than 200 health care providers and payers covering about 85% of the pay your lives the bed understand how to have your pin them H B R will fit into the C. U T I treatment paradigm.

And the feedback that we received based on these interactions have been has indicated but if <unk> H B R is approved that they're strong interest of these health care providers to use it and both of community and the hospital discharge setting.

In pairs has <unk> they've indicated a strong willingness to cover Kirby paint on.

And health care providers and payers indicate the potential for value based pricing.

Christina Larkin: Now, this is due in large part to the strong phase three data showing that TebipenumHVR can deliver value to all of our relevant stakeholders, including patients and healthcare providers and payers. Now looking forward, we plan to take a phased approach to billing out our commercial team. We started with hiring key leadership almost two years ago in our marketing, market access, and medical affairs departments to set our strategy.

Now this is due in large part because of the strong phase three data showing that have U Penn M. H B R can't can't deliver value to all of our relevant stakeholders, including patients and health care providers and payers.

Now looking forward, we plan to take of phased approached of billing out of our commercial team. We started with hiring key leadership almost two years ago on our marketing market access of medical affairs to set our strategy.

Christina Larkin: And over the last year, each of them has added individuals with deep expertise in launching new products and antibiotics to further build out their organization. And one group I want to highlight is our medical liaison team, which David and Onkip both mentioned. This has been deployed for over a year.

And over the last year each of them have added individuals with deep expertise and and launching new products and antibiotics to further build out their organizations.

And one group I want to highlight is are medically as on team that day, but they're not hit those mentioned and this has been been <unk> been deployed for over a year and they've been out speaking to a key opinion leaders to help build out this early advocacy development.

Christina Larkin: And they've been out speaking to our key opinion leaders to help build out this early advocacy development. And lastly, our sales force, these will be the last to be deployed. And we anticipate that we will wait till we are closer to our approval before we start filling out this part of the organization. Now we have a very exciting time ahead of us, and we believe that we are well positioned for success. Now, with all of this, I'm going to turn the call over to staff who will provide you with a financial update.

And lastly, our sales force these will be the last to be deployed and we anticipate that we will wait til we are closer to our approval before will start filling out this part of the organization.

Now we have a very exciting time ahead of us and we believe that we are well positioned for success.

Now with all of this I'm going to turn the call over to Sac will provide you with of financial update staff.

Christina Larkin: Thank you, Christina, and good afternoon, and I'd now like to turn to your lawyer for our overview of service financial results for the quarter ended March 31, 2021. Social revenue for the first quarter of 2021 was 7.3 million, compared with revenues of 1.7 million in the first quarter of 2020.

Major of Christina and you have a good afternoon, everyone right.

Right now I'd like to turn your attention to our overview of spirit of this financial results.

For the car to of ended March 21, 2021.

Clifford revenue for the fourth quarter of 2021 was 7.3 million compared with revenues of 1.7 million in the first quarter of 2020.

Satyavrat Shukla: Social revenue for the first quarter of 2021 was higher than the same period in 2020. Future grant revenue received through the Baja contract for Chbipanam. As a reminder, we currently have total committed non-dilutive funding from Baja of approximately 44 million, inclusive of 10 million in funding from the Defense Threat Reduction Agency or, We have accounted for 27.7 million of committed funding from Baja as of the end of March 31st. Beyond the current commitment, there is a second option of 12.7 million that remains exercisable by the body.

Revenue for the book QUADRA of 2021 of those higher than the same period in 22 twin to ditch of grants revenue received to the border contract like have you been an H B R.

As a reminder, we currently have poured will come in entered non judge of funding from bedroom of approximately 44 million inclusive of 10 million and funding from the defense threat reduction agency decor.

Yeah. That's no good for 27.7 million of committed funding from BARDA as of the end of March 31st and beyond the courage commitment. There is a second option of 12.7 million that from Ya exercisable by Barbara.

Satyavrat Shukla: Research and Development Expenses for the first quarter of 2021 were 18.4 million dollars, compared to 20.4 million of R&G expenses for the same period in 2020. This year-over-year decrease was primarily due to winding down of phase three activities for Tubby Penham HVR, offset in part by investment to support the NGA filing. We expect our R&G expenses in 2021 to be consistent relative, I will note that some of the research and development expenses we expect to incur in 2021 include costs related with the expected Tabipenum HBR NG submission and medical affairs strategy, as well as personnel-related spend to support the General and Administrative Expans, for the first quarter of 2021 of 8.3 million, were higher than the 4.1 million reported in the same period in primarily due to increased professional expenses and personnel costs to support the company's pre-commercial, We expect CNA expenses to increase in 2021 relative to 2021, as we build commercial capabilities and the infrastructure support the expansion ahead of a potential Chebipanam HBR commercial law, in 2020.

Research and development expenses for the first quarter of 2021, what $18.4 million.

<unk> 220.4 million of all right and D expenses, but he same period, it's been 2020.

This ear over your degrees was primarily due to a winding down a phase three activities for to have you been an H B O.

Of such an posh by investment of support D. N G of fighting but have you been on matriarch.

We expect of Orangy expensive in 2021.

Be consistent relative to 2020.

Of a note that some of the research and development expenses be expect to incur in 2021 includes costs related would be expected to have you been on H B R. A N D of submission and medical of fifth strategy as well of course not of related expense to support the pipeline.

General and administrative expenses for the first quarter of 2021 of 823 million.

Well higher than the 4.1 million reported in the same period in 2020.

Primarily due to increased professional expenses and of course, no cost to support the companies pre commercial efforts.

We expect Q&A expenses to inquiries in 2021 relative to 2020.

Is he both of commercial capabilities and the infrastructure to support the expansion of head of a potential to have you put on them H B R. Commercial launch in 2022.

Satyavrat Shukla: We reported a net loss for the first quarter ended March 31, 2021, of 19.4 million, or 66 cents per common share, compared to a net loss of 23.3 million, or a dollar 22 per common share, reported for the same period in 2020. As of March 31, 2021,

We reported in net loss of the first quarter of ended Marsh cause you in 2021 of 19.4 million or 66 cents per of common shoe from between net loss of 23.3 million dollar 22 per common share the budget for the same period in 2020.

As of last or do you want 2021.

Satyavrat Shukla: We had cash, cash equivalents, and marketable securities of 115.7 million. We believe that our existing cash, cash equivalents, and market tool securities, together with a non-daiute funding will be sufficient to fund operations into the second quarter of 2022, including through the submission of the NGA for Chabipan. For further details, please refer to our 10-Q5s with the ESP. Would you now like to open the call for questions? Operator

He had cash cash equivalents and marketable securities of 115.7 million.

Do you believe that's out of existing cash cash equivalent of marketable securities.

Of it of non <unk> funding commitments will.

Will be sufficient to fund operations into the second quarter of 2020 true including to the submission of of the N. G Force everything on H B O.

But further details on on financial.

Please refer to watch on queue fries with the a C C. Today.

You wouldn't know like to open the call for questions operation.

Operator: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask your question, please press star zero or star one on your telephone keypad. A confirmation tone will indicate your line is in the question Q. You may press star 2 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 the start button.

Thank you.

Son will be Kentucky on your question and answer session.

If you would like to ask a question. Please press does your star one on your telephone from from.

A confirmation some of them will indicate your line isn't of question Q.

Press Star too if you would like to move remove your question from the queue.

Four of purpose from Susan speak of equipment may be necessary to pick up your handset before president of starches. One moment, please while we pull for questions.

Operator: One moment, please, while we pose a question. Our first question is from Ritu Baral of Cowan. Please, Hi guys. Thanks for taking the question. Good afternoon.

Our first question is from <unk> of town. Please proceed.

Hi, guys. Thanks for taking the question good afternoon.

Ritu Subhalaksmi Baral: First question, I guess in your pre-NDA meeting, did any either review issues or potential review issues arise? Other, were there any surprises, I guess, from your expectations going in or from your questions asked of the agency? And then I have a follow-up. Thanks, Ruthu, for the question. Good to hear from you.

First question I guess in your <unk>.

C N D a meeting.

Did any either of review issues or potential review issues arise other were there any.

Surprises I guess from your expectations going in or from your questions questions asked of the agency and then I have a follow up.

Yeah, well thanks for a day for the question good to hear from you. The the in shortly to there were no surprises from the pre N D. A discussion and I reiterate the most important takeaways, which is one on the basis of that meeting we're on track of submit the N D. A's per of guidance on the second half of the year and that the.

Ankit Mahadevia: In short, Rithu, there were no surprises from the pre-NDA discussion, and I reiterate the most important takeaways, which is one on the basis of that meeting. We're on track to submit the NDAs per our guidance in the second half of the year, and the FDA endorsed the structure and form of our plan submission and, you know, also the data set and the CMC plan that we've communicated publicly before. So we're pleased with the outcome of that meeting. Got it. And then I guess this is much more of an existential question.

D. A endorsed the structure of form of our plan submission and you know also the date of set on the C. M. C plan that we've communicated publicly before so we're we're pleased with the outcome of that meeting.

Got it and then I guess this is much more of an existential question, but has I guess.

Ankit Mahadevia: But has COVID, COVID quarantines, social distancing norms, et cetera, et cetera, has that changed patterns of resistance in the community as far as you can tell such that it might impact your commercial strategy for Khabi PENM or have rates of chloroquinoid resistance or other key resistance patterns pretty much stayed the same? Yeah, thanks for the forward-looking question, Rithu. The short answer is, no; the continued march of chloroquinolone and extended-spectrum beta-lactam resistance continues apace.

<unk> COVID-19 COVID-19 quarantines, social distancing norms et cetera, et cetera has that changed patterns of resistance in the community as far as you can tell them such that it might impact of your commercial strategy for tabby Penn M or have.

<unk> for quite a load of resistance or other key resistance patterns pretty much the same.

Yeah. Thanks for the the the forward looking question <unk>. The short answer is no. The the the continued March of floor quinolone and extended spectrum beta lactam resistance continues apace, we continue to monitor this both monitor this both by reviewing public surveillance data as well as doing our own.

Ankit Mahadevia: We continue to monitor this both by reviewing public surveillance data as well as doing our own surveillance work under a study called Stewart. Both of those point to the fact that we continue to have high and increasing levels of resistance to existing oral therapies. And I'd sort of add on as well to keep in mind that the pandemic has accelerated the trend of identifying patients that are most appropriate to see outside of institutional care settings, like hospitals and skilled nursing facilities. And so the pandemic has been an accelerant to the understanding that there is a need for good oral options for these patients. I got it.

<unk> work under a study called Stewart and both of those points to the fact that we continue to have high and increasing levels of resistance to existing of world therapies, and I'd sort of add on as well to keep in mind that that the the pandemic has accelerated the trend of identifying patients that are most.

For you to see outside of institutional care settings, like hospitals, and skilled nursing facilities and so the pandemic has been an accelerant to the understanding that there's a need for good aware of options for these patients.

Ritu Subhalaksmi Baral: I'm going to squeak one last question in there. Just to clarification, you had mentioned that there may be moving to 720 and clarification of the unexplained mortality in the non-human primate. You had mentioned that there could be dosing specific issues along with potential species specific issues. By dosing, are you, particularly referring to the trauma that goes along with oral garbage?

Got it on the Squeak one last question in there just a clarification you had mentioned that there may be.

Moving 720, and clarification of the unexplained mortality and the nonhuman Primate you had mentioned that there could be dosing.

Dosing specific issues, along with potential of species Fisher specific issues by dosing or you just particularly referring to the trauma that goes along with all of <unk> is that like when you're talking about dosing methodology, rather than like dosing timer.

Ankit Mahadevia: Is that, like, were you talking about dosing methodology rather than, like, dosing time or level? Yeah, Ricku, yeah, that's consistent with what we've said in prior public discussions about this. The method of administration to these adult primates can be problematic.

Level.

Yeah, <unk>, yeah that that's consistent with what we've said in a prior public discussions about this the the method of administration to these adult daughter, I'm H can be problematic.

Ankit Mahadevia: Yes. Great, thanks for taking all the questions. I appreciate it.

Yeah.

Great. Thanks for taking all the questions I appreciate it.

Operator: Thank you. Thank you. Our next question is from Louise Chen of Cancer Fitzgerald. Please, Hi, congratulations on all the progress this quarter, and thanks for taking my question. So my first question was, what do you think has driven an increasing interest by large pharma companies in anti-infectives and antifungals? We've seen some notable collaborations with large pharma, and then recently saw Pfizer acquire Amplex. So just curious about your thoughts there and what you're seeing on your side.

Thank you.

Thank you and the next question just from Louise Chen of Cantor Fitzgerald. Please proceed.

Hi, congratulations on all of the progress of this quarter and thanks for taking my questions. So my first question was what do you think is driven an increasing interest by large firm of companies and anti in fact as in Antifungals. We've seen some notable collaborations with large firm and then recently saw Pfizer acquire amply.

Ex.

So just curious on your thoughts day on what you were seeing on your side.

Louise Alesandra Chen: Second, how are you going to manage the resource constraints around COVID that the FDA has experienced? Have you, in your interactions with the FDA, had any delays in your process forward with your NDA submission? And then lastly, how will you ensure that Spira will not face the same challenges that other antibiotic companies have faced in their launches? Thanks, Louise.

Second question is how are you going to manage through the resource constraints around COVID-19 that the F. D. A has experienced have you and your interactions. The F. D. A had any delays in your process forward with your Andy of submission.

And then last question I had is how will you ensure that sparable not phase of the same challenges that other antibiotic companies have faced and their lunch. Thank you.

Ankit Mahadevia: Thank you for the questions. We'll take them in order. So number one is as it relates to the large pharma partnering landscape, and yes, we've observed the same trend as well that we're seeing large pharma starting to invest and invest heavily in innovative medicines in our field. You know, there are two drivers of this one: one is that, you know, the pandemic has been a broad societal reminder of the need for new options for infection.

Thanks Louise so thank you for the questions, we'll take them in order. So of number one is as it relates to the large farm partnering landscaping and yes, we we would share the same trend as well that we're seeing large form of starting to invest and invest heavily in innovative medicines in our in our field.

You know there are two drivers of this one is that you know the pandemic has been a broad societal of a reminder of the need for new options for infection. Secondly, several big farmers have built of portfolio on a building of portfolio around the attraction day gained around either COVID-19 therapeutics or vaccine.

Ankit Mahadevia: Finally, you know, several big pharmas have built a portfolio or are building a portfolio around the traction they've gained around either COVID-19 therapeutics or vaccines. And finally, you know, for the right programs, and we built our pilot on the right.

And and finally, you know for the right programs and and we built our part of it.

Ankit Mahadevia: It makes good business, opportunities to both address an important value proposition clinically for patients but also economically for differentiated medicines. And so we've noticed that, as it relates to your second question around resource constraints and the impact of the pandemic on FDA, we have not seen that in our collaborative discussions with the agency to date. As we look ahead, the FDA continues to be extremely collaborative with us, both in our direct interactions, as well as recent guidance they've issued on what options they have to be able to continue to meet the needs of patients through the pandemic.

From <unk>.

Alright opportunities to both of address on important value proposition clinically for patients, but also economically in it for differentiated medicines and so we've noticed that.

Interest you as it relates to your second question around resource constraints on the impact of depend on like on F. D. A we have not seen that within of our collaborative discussions with the agency to date you know as we look ahead. The F. D of continues to be you know extremely collaborative with us of both in our direct interactions as well as.

Recent guidance as they issued on what options they have to be able to continue to meet the needs of patients through the pandemic. I'd also note that they've also released data recently that notes for example that out of 13500 request for authorization that.

Ankit Mahadevia: I'd also note that they recently released data recently that notes, for example, that out of 13,500 requests for authorization that they have been reviewing from March 2020 to March 21, 68 of those had some sort of COVID-related resource impact.

They have been reviewing over the past March 2020th of March 21.

68 of those had some sort of COVID-19 related resource impact and so yeah I think both covered by the collaborative relationship that we have and the guidance from the agency as well as the the kind of of the the the focus magnitude of this particular issue and finally, the fact that we have a leg up in a head start in debt the.

Ankit Mahadevia: And so, you know, I think both are covered by the collaborative relationship that we have and the guidance of the agency as well as the kind of focused magnitude of this particular issue. And finally, the fact that we have a leg up and a head start in that the medicine that we've been developing has been on the market in Japan for 10 years. Just a lot of confidence about the path forward.

<unk> that we've been developing has been on the market in Japan for 10 years.

There's just a lot of confidence about the path forward.

Christina Larkin: Now to your third question about why Tebby Penham is such a differentiated program in the marketplace, I'll hand that one to Christina. Yeah, I think, you know, I think one of the most important things, and we've talked about this from the beginning, that, you know, one, I think going to market is that you don't want to compete with generics, and I think, you know, the one key differentiating feature here is that, you know, we're going after a market for where we're not looking to compete with generic agents and where, you know, these patients are ultimately leading where they are either on the verge of hospitalization or going to an IV therapy.

No no to your third question about why Tubby pet on me such of differentiated program in the marketplace all him that one day Christina.

[noise], Yeah, I think you know I think one of the most important things and we've talked about this from the beginning that you know one I think going to market is that you don't Wanna compete with generics and I think he made of one key differentiating feature here is that you know we're going after of market for where we're not.

Looking to compete with generic agents and where you know these patients are are ultimately leading where they are either on the first of hospitalization or are going to an ivy therapy and that's this opportunity to avoid of hospitalization Lynch offers of clinical on economic advantage or to get patients out of the hospital on whether it's.

Christina Larkin: and that's this opportunity to avoid a hospitalization, which offers a clinical and economic advantage, or to get patients out of the hospital where there's a strong economic and clinical reason to do that. And I do think that's a key value proposition that we're offering. That doesn't exist today.

Strong economic and clinical reason to do that and I do think that's a key value proposition that we're offering that doesn't make sense today and I think that's one of the major advantages I think the second is is that you know the reimbursement model for this antibiotic is going to be different than the other antibiotics that we've seen much of the last decade.

Christina Larkin: And I think that's one of the major advantages. I think the second is that, you know, the reimbursement model for this antibiotic is going to be different than the other antibiotics that we've seen launched over the last decade, where the primary reimbursement model for a drug like Kevi will be outside of the laws of the hospital, even that a hospital discharge patient that we just referenced will be a patient for which the primary payer will be outside of the laws of the hospital. So those are some of the key drivers, I think, you know, importantly, that we talk about that will be major differences, you know, differences in other launches that we've seen. Thank you very much.

Where the primary reimbursement model for a job like <unk> will be outside of the loss of of the hospital, even that of hospital discharge patient that we just reference will be of patient for where the the primary payer will be outside of the will also at the hospital.

So those are some of the key drivers I think you know importantly that we talk about that it'll be major difference in of differences in another launches that we've seen.

Thank you very much.

Operator: Thank you. Our next question is from Kevin de Guter of Oppenheimer. Please proceed. Hey, great, thanks for taking my questions and, you know, congrats on all the progress. I guess really, maybe two questions for me.

[noise] [noise]. Our next question is from Kevin Decatur of Oppenheimer. Please proceed.

Okay, great. Thanks for taking my questions and yeah. Congrats on on on the progress Uhm I guess really maybe two questions for me.

Kevin de Guter: You know, on 720, I think David mentioned that there's ongoing, Rats Buddy. Can you just provide us some context as to when that's anticipated to wrap up and, in any context as to whether FDA suggested that they would want to see some of that data while making a decision on how to address clinical hall around 720? And then just as we think about, you know, the financial guidance and specifically cash burn, how should we think about, you know, impact, potential Tevipenum pre-launch inventory build, and another kind of pre-launch working capital that is sort of factored into, you know, the 2021 sort of R&D spender, should we think of, you know, the pre-launch inventory bill as being more of a 2022 spend item? Thanks,

Yeah on 720th of David mentioned that day ongoing Uhm wrap study.

Can you just provided some contact with you when that size anticipated too wrap up and and any yeah of context as to whether you'll have day suggested that they would want to see some of that day at yeah, while making a decision on on how to address the critical of all around 720.

And then just as we think about.

Ankit Mahadevia: Thanks for the questions. On your first question about what we will need to have a substantive dialogue with the agency, I'll reiterate what David mentioned, which is that by the third quarter, we expect to have everything we need to have a substantive dialogue about the program with the agency. As it relates to your second question, I'll pass it to the soft to talk about our financial performance. Thanks, Kevin, for the question. Our expectation is that most of the inventory bill will start, much like a lot of other commercial spend in 2022. You know, 2021 will be laying the groundwork in every way, from personnel to supply, but the majority of that spend will be deferred to a little later.

Satyavrat Shukla: Great, thanks for taking my question. Thank you. Our next question is from Esther Hong of Berenberg. Please proceed. Hi, thanks for taking my questions and congratulations. So on SPR 720, what would an alternate animal toxin look like? Would we use a different animal species of age or not? I guess, what would it look like?

Our questions and congratulations on everything so on S. P of $7 20, what wouldn't an alternate animal Tox study look like would you use of different in of species of.

Of age or or non I guess, but what would it look like and and then on just in general on heavy pen on H B R. D patent of state.

Esther P. Rajavelu: And then just in general, on Tebbi Penum, HBR, the Patent Association. I know that you were recently granted a new patent. Can you remind us of the independent state for Thanks, yeah, thanks, Hester, for the questions.

You recently granted of new patent can you remind us of the.

Dependent state for a couple of your pen on thanks.

Yeah.

Thank you for the questions on your first question.

Ankit Mahadevia: On your first question, you know, I guess it's not. Our objective is that we'll have exactly what we need to have a substantive discussion with the agency by the third quarter. We haven't said anything in our public remarks, nor do we have an expectation that we need any alternate studies beyond the one that we've guided publicly to already. You know, as it relates to your second question, I'll ask, I'll hand it to Christina to talk about our patent state.

I guess, it's it's not.

Yeah.

Our objective is that we will have exactly what we need to have a substantive discussion with the agency by third quarter. We haven't said anything on a public remarks, nor do we have an expectation that we need any alternate studies be on the one that we've guided to publicly already.

You know as it relates to your second question I'll ask a hand of the Cristina to talk about our patent mistake.

Ankit Mahadevia: Sure, so we, as you recall in good memory, we were granted a patent on our crystalline salt form that was issued in January of this year, and that does take us out to 2038. You may recall as well that we were granted QIDP, and that gives us a guaranteed 10 years of exclusivity as well. So those are two areas of patent protection as well. We do also have a patent pending as well around our formulation patent, and that would actually carry us out to 2037.

Sure. So we achieve a call on it and it's good memory, we were granted on a patent on our crystalline salt form that was issued in January of this year and that does take us out to 2038, you may recall as.

Well that we were granted Q I D P and that gives us a guaranteed of 10 years of exclusivity as well. So those are two areas of patent protection as well. We do also have a patent pending as well around our formulation patent and that would actually carry us out to 'twenty are 37. So that's an additional area of added per.

Ankit Mahadevia: So that's an additional area of added protection for us as well, you know, when issued. So hopefully, that will give you some ideas around, you know, both the regulatory protection and then also, I think, the additional IP protection that carries this out to an extension of 2038, both in what's been granted and what's pending. Thank you. Our next question is from Ram Salvarahou of H.C. Wayne Wright. Please proceed. Hi, thanks very much for taking my questions. Just a couple of quick ones here.

<unk> for us as well.

You know when issued so hopefully that'll give you some some ideas around you know both of regulatory protection and then also I think the additional IP protection that carries us out to an extension of 2038, both on whats been granted then what's pending.

Okay, great. Thanks.

Okay.

Yeah.

Thank you on.

Next question is from Rome, So of work so their Uh huh of.

H C. Wainwright. Please proceed.

Hi, Thanks, very much for taking my questions just a couple of quick ones here.

Ram Salvarahou: With respect to SPR 206, I was wondering if you could just elaborate on once you have the next round of clinical data and conduct the clinical studies that are going to be yielding information in early 2022. If you can just kind of clarify what you expect to be the timeframe between the release of those data sets and the initiation of the next round of clinical development, assuming, of course, that the agent advances to the next stage after these initial studies report out. Yeah, thanks, Ron for the question. We are. I'm glad you asked about 206.

With respect to S. P R. Two of six.

I was wondering if you.

Could just elaborate on once you have the next round of clinical data and.

Conducting the clinical studies that are going to be yielding.

Yielding information in early 2022.

If you can just kind of clarify what you expect to be the timeframe between the release of those datasets and the initiation of the next round of clinical development assuming of course that the.

The agent advances to the next stage. After these initial studies report out thank you.

Yeah. Thanks from for the question. We are I'm glad you asked about two O. Six you know we continue to see an unmet need for patience.

Ankit Mahadevia: We continue to see an unmet need for patients that have multi-drug-resistant infections. COVID also highlights the need for better antibiotics for patients that are ventilated. These patients get broad-spectrum antibiotics. They often have resistant co-infections, and we need better options for these ventilated patients because they often die of bacterial infections as much as they die of what brought them to the hospital in the first place.

Debt have multi drug resistant infections of COVID-19 also highlights the need for better antibiotics for patients that are ventilated. These patients get broad spectrum antibiotics. They often have resistance co infections, and we need better options for these ventilated patients because they often die of bacterial infections as much of the guide of what they brought them into the.

Ankit Mahadevia: And just as a reminder, those phase one studies are important because they guide us on how 206 can be best used to help those patients, in particular the Bronchral dealer-Levage study, which will help us see how well 206 gets into the lungs, which will be important for the ventilated patients who make up a lot of that patient population. In terms of what's next, what we can say is that it'll be a study in patients with infection to show what 206 can do.

Hospital in the first place and just as a reminder, those phase one studies are important because they they guide us on how to best how to of six can be best used to help those patients in particular, the Bronchoalveolar lavage study, which will help us see how well two of six gets into the lungs, which will be important for the ventilated patients who make up a lot of that patient population.

<unk> in terms of what's next what we can say is that it'll be a study in patients with infections to show what two of six can do we have some data to collect both from the renal study and the study.

Ankit Mahadevia: We have some data to collect both from the renal study and the BAL study, which David mentioned, I think before we could be more definitive on the timing of a study start because the phase one studies will inform the design, and the design will inform the two. Okay, and with 720, uh, Assuming that there isn't anything specific to link to the drug in the non-human primate toxicology study report, first of all, do you have a sense of how long it might take the agency to review that study report, if they are going to be reviewing any other meaningful data sets, clinical or otherwise, in the context of assessing when it will be appropriate to lift or maintain the clinical hold on

Which David mentioned I think before we can be more definitive on the timing of of studies start because of the phase one studies will inform the design and the design will inform the timing.

Okay and with 720.

Assuming that there isn't anything specific to linked to the drug in the non human Primate Toxicology study report.

First of all do you have a sense of how long it might take the agency to review that study report if they are going to be reviewing any other meaningful dataset.

Clinical or otherwise.

In the context of assessing when it will be appropriate to lift or maintain the clinical hold on 720, and then lastly, assuming that the.

Ankit Mahadevia: And then lastly, assuming that the study report looks clean and that the FDA concurs that it is clean, what would be the next logical clinical development step for 720? Would it be effectively, uh, restarting another phase two-way trial that follows exactly the same design as the original phase two-way trial or, Yeah, Ron, thanks for the question.

The.

Saudi report looks clean and that the FDA concurred that it is clean what would in fact be the next logical clinical development of step for 2020 would it be effectively.

Restarting of of of another phase Iia trial that color of exactly the same design as the original phase Iia trial or something else.

Yeah Ross. Thanks for the question you know as it relates to the.

Ankit Mahadevia: You know, as it relates to the, you know, timeline of their response, and they have a mandated note to give us a formal response to our interaction 30 days after we have that interaction. So, you know, we know that we'll know that at least. In terms of the overall timeline of, you know, what it will take for their analysis and review and, you know, a decision on a restart of a study, you know, that's something that we'll need to discuss with the agency as we send them the data. But we know that, you know, their history with us thus far has been, you know, a collaborative stance and timely responsiveness to our requests. And so, you know, we would expect that that would continue.

You know the the the timeline of day response, and they have a you know a man of mandated note to you gave us a formal response to our interaction 30 days. After we have that interaction. So we know that we will no doubt at least in terms of the overall timeline of what it will take for there.

Analysis and review and a decision on a restart of the study.

That's something that we'll need to have the discussion with the agency as we send them the data, but we know that.

Their history with us thus far has been you know.

Our collaborative stance and timely responsiveness to our requests and so we would expect that that would continue as it relates to the nature of the study again, that's dependent on the discussion with FDA, when we kind of when David and I. Both noted that based on the data to date, we see a species specific.

Ankit Mahadevia: You know, as it relates to the nature of the study, again, that's dependent on the discussion with FDA. You know, when David and I both noted that based on the data to date, we see a species-specific and dosing-specific explanation that's supported by the data. If the NTA does agree with that, I think that that would be supportive of, you know, the type of study that we have already discussed publicly to show what 720 can do as a single agent to drive down disease burden and NTP.

<unk> and dosing specific.

Explanation that supported by the data.

D. A doesn't agree with that I think that that would be supportive of us.

On the type of study that we have already discussed publicly to show what seven 'twenty you can do as a single agent to drive down disease burden of MTN patients.

Ankit Mahadevia: But again, I would caveat that we need to finalize our analysis, as well as have the discussion with the agency, to finalize that. But we can certainly comment on what we've seen in the data. Okay, and just one very quick question regarding Tevi Penham. Can you give us a sense of when you anticipate being able to disclose the proposed U.S. trade name, where in the process that might occur between, you know, finalizing the NDA submission and actual approval of the drug? That one I'll hand to Christina to address. Sure, thanks. So there's obviously a couple of different components. One is, you know, the trademark component, and the other is the FDA acceptance of the name.

But again I would caveat that we need to finalize our analysis as well as have the discussion with the agency to finalize that but we can certainly comment on what we've seen in the data to date.

Yeah.

Okay, and just one very quick one regarding turbot kind of can you give us a sense of when you anticipate being able to disclose the.

Proposed U S trade name, we're in the process that might occur are.

Between you know finalizing the NDA submission and the actual approval of the drug. Thank you.

That went on all I'll hand of Christina to address.

Sure. Thank so there's obviously a couple of different components that one is on you know the trademark component of any other is the FDA acceptance of the name and so I would tell you that we're in the works of the all of that and.

Christina Larkin: And so I would tell you that we're in the process of all of that. And, you know, we will publicly disclose some of that data to be disclosed later at a later date. Thank you. Thank you. Ladies and gentlemen, we have reached the end of the question and answer session, and this will conclude today's conference. Thank you for your participation and have a great day.

We will publicly disclose some of that data to be disclosed later at a later date.

Thank you.

Yeah.

Thank you.

Gentlemen, we have reached the end of the question and answer session and this will conclude today's conference. Thank you for your participation and have a great day.

Yeah.

Yes.

Yeah.

Right.

[noise].

Yeah.