Q1 2020 Earnings Call

By the says the conference operator.

Operator: This is a conference operator. Welcome to the Spero Therapeutics

Welcome to the so that's good.

Unknown Executive: First Quarter 2020 Ernest Conference Call

That's what it 2020 on this conference call and corporate update.

Operator: and Corporate Update. As a reminder, all participants are in listen-only mode, and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star, then 1 on your telephone keypad. Should you need assistance during the conference call, you may signal an operator.

As a reminder, all participants I listen only mode and the conference is being recorded.

After the presentation, there will be an opportunity to ask questions right. A question in queue. You May Press Star then one on its all thinking about.

Do they need assistance or the call. This fall you buy said, one operator, I think start and Jill.

Operator: Unknown Operator, Star, and Zero.

Oh that I've done the comps over to shots or VP of IR. The strategy. Please go ahead.

Sharon Thayer: I would now like to turn the conference over to Sharon Thayer, VP of IR and Strategy. Please go ahead.

Great. Thank you operator, thank you all for participating in todays conference call.

Sharon Thayer: 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 review for the first quarter and March 31, 2020. If you have yet to see the press release, it's available on the investor page of the Spero Therapeutics website. Before we begin, I'd like to remind you that some of the information contained in the news release and on this conference call contains forward-looking statements based on our current expectations. Such forward-looking statements are not a guarantee of performance, and the company's actual results could differ materially from those contained in these statements. Several factors that could cause or contribute to these differences are described in detail in Spero Therapeutics' filings with the SEC. However, these forward-looking statements speak only as of the date of this press release and conference call. And the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the company.

Earlier today spare Therapeutics released financial results provided a pipeline review for the first quarter ended March 31st 2000.

Do you have yet to see the press release, it's available on the Investor page that they're Spiro therapeutics website.

Before we begin I'd like to remind you that somebody 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 could differ materially the notes contained in their stuff.

Several factors that could cause or contribute to these differences are described in detail.

Therapeutic filings the FCC.

These forward looking statements speak only as of the date of this press release conference call.

And the company undertakes no obligation to publicly update any forward looking statements or supply new information regarding the company.

After that date today's release in call.

Sharon Thayer: 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. Christina Larkin, Chief Operating Officer, and Steve DiPalma, Interim Chief Financial Officer. With that, I'd like to turn the call over to Dr. Mahadevia. Please go ahead.

Participating in today's call from Spiro.

Dr. all get Mydeighty.

Chief Executive Officer.

Dr., David Melnick, Chief Medical Officer, Chris.

Christine Alaskan Chief operating officer, and see if deposit in travel Chief Financial Officer.

With that I'd like to turn the call over the Doctor and get my Baby. Please go ahead.

Thank you share and good morning, everyone.

Ankit Mahadevia: Thank you, Sharon, and good morning, everyone. This is our first time hosting a quarterly call and business update, so thank you for joining us.

This is our first time hosting a quarterly calling business update so thank you for joining us it's a very exciting time for Sarah with our phase three trial for TV panel. Each we are now fully involved and top line data expected in the third quarter.

Ankit Mahadevia: It's a very exciting time for Spero with our Phase 3 trial for Tebipenem HPR now fully enrolled and top-line data expected in the third quarter. If successful, this study will set us up on a path for potential regulatory approval for our most advanced product. Joining me on the call today is Dr. David Melnick, our Chief Medical Officer, who will discuss recent progress with Tebipenem HBR as well as provide a pipeline update. Christina Larkin, our Chief Operating Officer, will talk about the commercial opportunities for the lead assets. And Steve DiPalma, our Interim CFO, will discuss the financing.

If successful this study will set us up on a path what potential regulatory approval for our most advanced product.

Joining me on the call today is Dr., David Malbec, our Chief Medical Officer, who will discuss recent progress with heavy pennant hbr as well as providing pipeline update.

We're seeing a lock in our Chief operating officer will talk about the commercial opportunities for the lead assets.

And Steve Dipalma, our interim CFO will discuss the financials.

Let me start with the clinical progress we've made on all of our pipeline programs since the start of 2020.

Ankit Mahadevia: Let me start with the clinical progress we've made on all of our pipeline programs since the start of 2020. I'll begin with our lead candidate, Tebipenem HVR. Tebipenem HVR is an oral carbapenem. Our Phase 3 clinical trial, known as ADAPT-PO, is investigating tebupenem HBR for the treatment of complicated urinary tract infections and pyelonephritis. The trial is now fully enrolled with over 1,370 patients in the trial, and we continue to anticipate reporting top-line results from the trial in the third quarter of 2020. We believe that the ability to treat CUTI with an effective oral agent rather than currently used IV therapies would represent a dramatic improvement in the standard of care, one that would benefit patients, payers, and physicians alike. In January, we reported the FDA-granted orphan drug designation for oral SPR-720, a medicine for the treatment of non-tuberculous mycobacterial, or NTM, infections. This designation is given to drugs that treat a rare disease affecting fewer than 200,000 persons and that provide certain benefits and incentives for their development.

I'll begin with our lead candidate Temi kind of each PR or have you kind of hbr isn't all corporate pension.

Our phase three clinical trial known as adapt PEO.

He is investigating time dependent hbr for the treatment of complicated urinary tract infections and piling up rights.

The trial is now fully enrolled at over 1300, 70 patients and the trial and we continue to anticipate reporting topline results from the travel in the third quarter 2020.

We believe that the ability to treat see you T. I wouldn't effective oral agent rather than currently used and therapies would represent a dramatic improvement in the standard of care, one that would benefit patients payers and positions alike.

In January we reported the F.D.A. granted orphan drug designation for oral SPR 720, a medicine for the treatment or non tuberculosis mycobacterial for NTM infection. This designation is given to drugs that treat a rare disease affecting fewer than 200000 persons and that provides.

Certain benefits incentives for the drug development.

In January we also reported positive phase one results for IB next generation Poly Nixon agent that was developed as part of our Potentiator platform that is SPR two wells six the data supports advancement into additional clinical trials in conjunction with our partners at the department of defense and adverse medicines.

Ankit Mahadevia: In January, we also reported positive Phase 1 results for our IV, next-generation polymyxin agent that was developed as part of our potentiator platform and is SPR2L6. The data support its advancement into additional clinical trials in conjunction with our partners at the Department of Defense and Everest Medicine. On the financial front, we strengthened our cash position in the first quarter through a successful rights offering that closed on March 5th, where we generated net proceeds of approximately $29.5 million.

On the financial crop, we strengthened our cash position in the first quarter. If we're successful rights offering that closed in March that where we generated net proceeds of approximately $29.5 million.

Ankit Mahadevia: Proceeds from this offering extended our runway into the first quarter 21 and will support advancement of our antibiotic and rare disease pipeline. Now I'd like to shift focus a bit and share with you our thoughts on COVID-19 and how we are managing the business in the current environment. First, we'd like to say that the safety of our patients, collaborators, and employees is our top priority. We will continue to monitor the situation as we look to initiate clinical trials in the second half of 2020. We monitor the number of COVID-19 cases nationwide, as well as regulations, policies, and risk mitigation strategies in the jurisdictions and at the centers where we are conducting and plan to conduct our trials. These data make us comfortable with our current estimates, and our guidance remains unchanged for our pipeline.

It seems from this offering extends our runway into the first quarter 21, and will support advancement of our biotic in rare disease pipeline.

Now I'd like to shift focus a bit and share with you our thoughts on cold It 19, and how we're managing the business in the current environment.

First and we'd like to say that the safety of our patients collaborators and employees is our top priority.

We continue to monitor the situation as we look to initiate clinical trials in second half of 2020, we monitor the number of Colby. Thanks gene cases nationwide as well the regulations policies and risk mitigation strategies and the jurisdiction going up centers, where we are conducting and plan to conduct our trials. These data make us comfort.

Well with our current estimates and our guidance remains unchanged for our pipeline.

In the case of adapt PEO the phase three trial. That's now completed enrollment we were very fortunate to have already been at the latter end of enrollment when coupled with 19 cases began to accelerate we closely monitor the situation and then rolling countries and were able to guide.

Ankit Mahadevia: In the case of ADAPT-PO, the phase three trial that has now completed enrollment, we were very fortunate to have already been at the latter end of enrollment when COVID-19 cases began to accelerate. We closely monitored the situation in the enrolling countries and were able to guide enrollment to a successful conclusion. In addition, we continue to expect that the 720 Phase 2 clinical trial in patients with NTM disease will begin in the second half of this year.

Enrollment to a successful conclusion.

In addition, we continue to expect that the 720 phase two clinical trial in patients with NTM disease will begin in second half of this year.

We arranged for our employees to have the capability to work from home early which is minimized any business there were disruptions due to cope with 90.

Ankit Mahadevia: We arranged for our employees to have the capability to work from home early, which has minimized any business disruptions due to COVID-19. Now, shifting gears, there are a number of key strategic takeaways from the COVID-19 pandemic as it relates to our pipeline. Now more than ever, there's a push for patients to stay out of the hospital if it isn't essential to be admitted. Physicians do not want to expose patients to secondary infections, including COVID-19. And they don't want the hospital to lose money or take up a hospital bed treating a complicated UTI that could be better treated outside of the hospital if there was an effective oral antibiotic available.

Now shifting gears there are a at a 100000 feet. There are a number of key strategic takeaways from the called that 19 pandemic as it relates to our pipeline.

Now more than ever there's a push for patients to stay out of the hospital could isn't essential to be admitted physicians do not want to expose patients to secondary infections, including called the 19 and they don't want the hospital lose money or take up a hospital bed treating a complicated UTI either could be better treated outside of a hospital. If there was an effective or.

Valuable.

In addition, the pandemic highlights the importance of having anti infectives available when they're needed for.

Ankit Mahadevia: In addition, the pandemic highlights the importance of having anti-infectives available when they're needed for primary infections or infections secondary to COVID-19. While Spero isn't reliant on government incentives to further develop these important medicines, we have had the opportunity in developing these medicines to benefit from our partnerships with several agencies, including BARDA, the Department of Defense, and DITRA. During the pandemic, physicians are gaining comfort with using remote medicine and are looking for frustration-free methods to access care and medicine for their patients. Oral medicines that don't need to be managed through the formulary are an attractive option. Our ADAPT-TO trial that evaluates head-to-head oral tebupenem HBR versus IV ertepenem is designed to give physicians the confidence to prescribe tebupenem HBR without compromising outcomes. Now, to provide some more in-depth discussion on Spero's pipeline and clinical trials, I'll hand it off to our Chief Medical Officer, Dr. David Melnick.

Primary infections or infection secondary to cover 90.

Well sparrow isn't reliant on government incentives to further develop these important medicines, we've had the opportunity in developing these medicines the benefit from our partnerships with several agencies, including BARDA The department of defense and Detroit.

During the pandemic physicians are gaining comfort using promote medicine and are looking for frustration pretty methods to access care and medicines for patients all medicines, the don't need to be managed to the formulary aren't attractive option.

Our adapt field trial that evaluates head to head World have you kind of beach, we are versus I'd be are dependent is designed to get position the confidence to prescribed heavy pennant hbr without compromising outcomes.

Now to provide some more in depth discussion on spirits pipeline and clinical trials I'll ended up to our Chief Medical Officer Dr. David Mel.

Thank you, Okay and good morning, everybody.

I'd like to begin with our lead candidates have you kind of Hbr, which as I mentioned, we are developing for the treatment of complicated urinary tract infection.

David Melnick: Thank you, Ankit, and good morning, everybody. I'd like to begin with our lead candidate, Tevitam HBR, which, as Ankit mentioned, we are developing for the treatment of complicated urinary tract infections. We recently completed enrollment in our single pivotal phase three trial for tebupenem HBR, a clinical study that we have named ADAPT-PO. We remain on target to report top-line results from ADAPTEO in the third quarter of 2020.

We recently completed enrollment into our single pivotal phase three trial for capital image the art.

Studies that we have named adapt PEO.

We remain on target to report topline results from adapt Pos in the third quarter when you 20.

Adapt video is a non inferiority trial, comparing our drugs head to head versus the I'd be carpet tell them that is most commonly used to treat.

David Melnick: AdaptPO is a non-inferiority trial comparing our drugs head-to-head versus the IV carbapenem that is most commonly used to treat complicated urinary tract infections caused by drug-resistant pathogens. Over 1,370 patients were successfully enrolled into the trial, and they were randomized on a one-to-one basis to treatment with oral tebitinib HBR or intravenously administered ulipin We enrolled a greater number of patients into the study than our original plan of 1,200 patients in order to ensure that we maintained the statistical power of the study following an assessment of the response and evaluability rate at the 70% enrollment point. The primary endpoint is overall response rate, which is defined as the combination of clinical cure and microbiological eradication of the infecting pathogen at the test of cure visit in the microbiological intent-to-treat The primary endpoint, test of two, will be assessed 17 to 21 days after the first dose of study drug, and patients will be followed for a total of up to 27 days for a late follow-up assessment. Importantly, there is no IV lead-in with oral tebupenomal.

Complicated urinary tract infections caused by drug resistant pathogens.

Over 1300, 70 patients were successfully rolled into the trial and they were randomized on a one to one basis treatment with <unk>.

Pepitone Hbr would intravenously administered on them for seven to 10 days.

Enrolled a greater number of patients into the study than our original plan well do patients more who im sure that we maintained the statistical power of the study following an assessment of the response and the value building great. That's the 70% enrollment for.

The primary endpoint is overall response rate, which is defined as the combination of clinical cure and microbiological eradication of the infecting pathogen.

Just a pure visit in the Michael biological <unk> to treat population.

The primary endpoint test to be assessed 17 to 21 days. After the first dose of study drug and patients will be followed for total up to 27 days really follow up assessment.

Importantly, there's no I mean, we then we will have be Panama.

This allows the trial to really demonstrate the critical value proposition <unk> or <unk>.

David Melnick: This allows the trial to clearly demonstrate the critical value proposition for oral tebupenem, that is, the ability to treat serious antibiotic-resistant infections without the confounding presence of prior intravenous antibiotic therapy. If the trial is successful and Capipenem HBR is approved, then physicians would be able to prescribe an oral antibiotic for complicated UTI in place of intravenous therapy. That would allow a shift in care from the inpatient to the outpatient setting

That is the ability to treat series antibiotic resistant infections without the confounding precedence supplier you could Venus antibiotic therapy.

The trial was successful in Tempe Pelham Hbr is approved then physicians would be able to prescribe and oral antibiotic for complicated UTI are in place of intravenous therapy.

Well that would allow a shift in care from the inpatient to outpatient setting. This was an approach that is demonstrated to be effective.

David Melnick: This is an approach that has been demonstrated to be effective for the treatment of other serious bacterial infections, such as endocarditis, skeletal infections, and gram-negative bacteremia. And it will give clinicians the option to treat serious urinary tract infections caused by antibiotic-resistant pathogens with an oral antibiotic, a capability that currently doesn't exist. Capitanum HBR is unique in that it is the only carbapenem that has significant oral bioavailability.

Others serious bacterial infection searches and occurred I, just skeletal infections and gram negative bacteria and it would give clinicians the auctions serious urinary tract infections caused by antibiotic resistant pathogens with an oral antibiotics capability that doesn't exist.

Every tenant Hbr is unique in that it is the only carbapenem that has significant oral bioavailability.

We know that with approximately 60% bioavailability, we can deliver drug levels. The plasma in the size of infection that allow treatment with an oral agent to low.

David Melnick: We know that with approximately 60% bioavailability, we can deliver drug levels to the site of infection that allow treatment with an oral agent alone. In our phase one trial, as well as in the interim look at pharmacokinetics in our phase three trial, we demonstrated that drug levels sufficient to treat complicated UTI were delivered. Activity in complicated UTI is also supported by Phase II studies previously conducted by a Japanese partner, Meiji Seika. These studies demonstrated comparable response rates for efficacy as compared to intravenous antibiotics. Kebi Tenom HBR in powder form has been marketed in Japan for over 10 years, so we were fortunate to have a significant published safety database. That's the body of knowledge that we've generated about this molecule.

In our phase one trial as well as in the interim look at pharmacokinetics in or phase three trial, we demonstrated that drug levels.

Complicated UTI.

Were delivered.

Activity Uncomplicated UTI Ali is also supported by Phase two studies previously conducted by our Japanese partner made you sake.

Studies demonstrated comparable response rates.

For efficacy.

As compared to intravenous antibiotics.

Let me kind of Hbr as a powder warm has been more.

Well well over 10 years. So we're fortunate to have a significant published data base.

[laughter] body of knowledge that generated on this molecule.

Turning now to STR 720, which is targeted for the treatment of infections caused by non tuberculosis mycobacteria GM.

David Melnick: Turning now to SPR 720, which is targeted for the treatment of infections caused by non-tuberculous mycobacteria, or NTM. As you know, we announced positive results from our Phase 1 trial in December 2019. Results from that trial demonstrated that a healthy patient, doses of up to and including 1000 milligrams were safe and well tolerated over 14 days of repeated dosing. So we have a good safety profile coming out of the phase one trial at dose ranges that we believe will produce clinical efficacy in NTM patients based on our in vitro and animal NTM infection studies. We met with the FDA in early May and obtained guidance on our overall clinical program. We will be able to share more about these discussions after we receive the written minutes, but right now, I can say that we feel quite comfortable that there is a path with the regulators to move forward on SDR 720, and we continue to anticipate submitting an IND in the second half of 2020.

As you know, we announced our sort of results from our phase one trial in December 2019.

Results from that trial demonstrated that healthy patients doses up to including 1000 milligrams were safe well tolerated over 14 days of repeated dosing.

We have a good safety profile coming out of the phase one trial at dose ranges that we believe will produce clinical efficacy in NTM patients based on our in vitro animal MTM infection studies.

We met with the FDA in early May and obtain guidance on our overall clinical program.

We will be able to share more of these discussions after we received the written minutes, but right now I can say that we feel quite comfortable but there is a yeah with the regulators to move forward aren't as Youre 720, and we continue to anticipate submitting an R&D in the second here 2020.

Subject to FDA acceptance to the audience.

David Melnick: Subject to FDA acceptance of the IND, we plan to initiate a dose-ranging phase 2a clinical trial evaluating SBR720 in patients with pulmonary NTM disease in the second half of the year, which is another important milestone for our pipeline and for our company. As I have shared previously, our current plan is that the Phase IIa trial will be designed as a monotherapy trial. We expect to enroll MTM patients who are treatment inexperienced with the goal of assessing safety and tolerability, as well as pharmacokinetics and early microbiological response. If the results are positive, SBR 720 would be the only agent shown to drive an early microbiological response in NTM pulmonary disease as a standalone agent compared to placebo. Turning now to SPR 206, in January, we presented positive phase one data for 206, demonstrating that the drug was well tolerated up to a total of 300 milligrams daily for 14 consecutive days in healthy volunteers.

Turning to initiate a dose ranging phase two way clinical trial evaluating your seven pointing in patients with pulmonary MTM disease in the second half of the year, which is another important milestone for our pipeline for our company.

As I have shared previously our current plan is that the beach to wait trial will be designed as a monotherapy trial, we expect to enroll MGM patients who work treatment experience with the goal of assessing safety and Tolerability as well as pharmacokinetics and really Michael biological.

Oh.

If the results are positive as your seven point it would be only agent shown to drive and moving microbiological response, MTM pulmonary disease as a standalone agent.

Compared to placebo.

Turning now to as Youre to US six in January we presented positive phase one data to us six demonstrating that the drug was well tolerated up to a total of 100 milligrams daily for 14 consecutive days in healthy volunteers.

First of Benson. This study will mild to moderate they were no would serious we're severe adverse events.

David Melnick: Adverse events in this study were mild to moderate, and there were no reported serious or severe adverse events. Importantly, there was no evidence of nephrotoxicity, and there were no clinically significant changes in laboratory tests observed during the study. Based on these data, we intend to conduct further clinical trials in conjunction with our partners at NIAID and Everest Medicine, and we continue to anticipate beginning a phase one bronchoalveolar lavage study in healthy subjects in the second half of 2020. I will now turn the call over to Christina Lorkin, who will provide you with a review of the market opportunities for our pipeline products.

Importantly, there was no evidence of nephrotoxicity than there were no clinically significant changes in laboratory tests observed during the study.

Based on these data we intend to conduct further clinical trials in conjunction with our partners at Emory I D and Everest medicines.

We continue to anticipate beginning a phase one runkle out youre robotic study in healthy subjects in the second half Twentytwenty.

I'll now turn the call over the course, you know Morgan who will provide you with the review the market opportunity for our pipeline products.

Thank you David and good morning, everyone.

Christina Larkin: Thank you, David. And good morning, everyone.

There are three common themes across our to lead assets first they are large unmet need markets, where there are no generic alternatives.

Christina Larkin: There are three common themes across our two lead assets. First, they are large unmet needs markets where there are no generic alternatives. In fact, oral UTI and NTM are the largest markets in infectious disease today. Second, they have a strong value message directed at healthcare providers, payers, and patients. Finally, we expect that they will be reimbursed outside of the hospital. Let's start with tebipenem, HBR, and the complicated urinary tract infection, or C-UTI, market. As Ankit discussed earlier, now more than ever with COVID-19, the benefit of keeping patients out of the hospital is clear, and CUTI is no exception. In the U.S., for patients with UTIs that are resistant, reoccurring, and that have failed prior treatment, there is an increasing number of unnecessary hospitalizations annually in the U.S., and CUTI patients are staying longer in the hospital, not because they' And these increases appear to be linked to the increased emergence of resistance to currently available oral therapy.

In fact, oral U T I and NTM are the largest markets in infectious disease today.

Yes.

They have a strong value message directly that health care providers payers and patients.

Finally, we expect that there will be reimbursed outside of the hospital.

Let's start with heavy pet and H.B.R. and the complicated urinary tract infection or see yutai market.

As I won't get discussed earlier now more than ever but covert 19, the benefit of keeping patients out of the hospital is clear and see you T.I. is no exception.

In the U.S. for patients with U.T.I.s that are resistant recurrent and that have failed. Prior treatment. There is an increasing number of unnecessary hospitalizations annually in the U.S.

And cdti patients are staying longer in the hospital, not because they're sicker, but because of the lack of effective oral options.

These increases appear to be linked to the increase emergence of resistance to currently available oral therapies.

And these trends are impacting more than 2 million patients a year and U.S. alone.

Christina Larkin: And these trends are impacting more than 2 million patients a year in the U.S. alone, undeniably the largest unmet need market in infectious disease today. Currently, as David mentioned, the gold standard to treat these patients is carbapenem. But today, they are only available in an IV formulation. This is why we are excited by the commercial opportunity for tebupenem HBR. It has the potential to be the first oral carbapenem approved in the U.S. And from the patient and the healthcare provider perspective, orals are absolutely preferred, not only because of their convenience but to avoid the complications from an IV. And from a payer perspective, the opportunity to reduce total cost of care by reducing hospitalizations or helping with early discharge in the hospital are significant benefits, and all of this provides a great value foundation for a commercial launch following regulatory approval that can benefit all stakeholders.

Undeniably the largest unmet need market and infectious disease today.

Currently as David mentioned, the gold standard to treat these patients are carbapenems, but today. They are only available in an ivy formulation.

This is why we are excited by the commercial opportunity for Ted dependent H.B.R. It has the potential to be the first oral carbapenem approved in the U.S.

And from the patient and the healthcare provider perspective, Orals are absolutely preferred not only because of their convenience, but to avoid the complications from an ivy.

And from a payer perspective, the opportunity to reduce total cost of care by reducing hospitalizations or helping with early discharge in the hospital are significant benefits.

And all of this provides a great value foundation for our commercial launch following regulatory approval that can benefit all stakeholders health care provider the payer.

Christina Larkin: The health care provider, the payer, and most importantly, the patient. Now, let's shift gears to our pipeline. The second-largest opportunity in infectious disease is NTM, for which we'll be studying oral SPR-720. NTM is a rare orphan disease with a patient population of less than 200,000 in the U.S. It is a chronic debilitating disease, and treatment is often recommended for 9 to 12 months

And most importantly, the patient.

Now, let's shift gears to our pipeline, the second largest opportunity and infectious diseases, NTM, but which will be studying oral SPR 720.

NPM is a rare orphan disease with a patient population of less than 200000 in the U.S.

NTM, it's a chronic debilitating disease and treatment is often a recommended for nine to 12 months.

There was a significant unmet need for the more than 75% of non refractory NTM patients for which there are no FDA approved therapies.

Christina Larkin: There is a significant unmet need for the more than 75 percent of non-refractory NTM patients for which there are no FDA-approved therapies. Oral SPR 720 therefore has the potential to fill a significant unmet need for many of these patients. I'm now going to turn the call over to Steve, who's going to provide you with a financial update. Thank you, Christina, and good morning, everyone.

Oral SPR 720, therefore has the potential to fill a significant unmet need for many of these patients.

I'm now going to turn the call over to Steve Who's going to provide you with the financial update.

Thank you Christina and good morning, everyone.

Provide an overview sparrows financial results in the quarter ended March 31 2020.

Stephen J. DiPalma: I'll provide an overview of Spero's financial results for the quarter ended March 31, 2020. For the first quarter of 2020, reimbursement under our non-dilutive funding contracts was reported as revenue on our income statement. Total $1.7 million. This was lower than the $7.7 million that we reported in the first quarter of 2019. Due to lower funding for Tevinum from HBR under Spero's contract with the Biomedical Advanced Research and Development Authority, or BARDA, due to the timing of qualified Tempe-Panamasekar expenses incurred during the first quarter of 2020. I would also note that the first quarter of 2019 included a $3 million upfront payment associated with our Everest Medicines license agreement, which we entered into in January 2019. In February 2020, we announced that BARDA conducted its first contract auction to run an additional $15.9 million in committed funding.

First quarter 2020 reimbursement under our non dilutive funding contracts reported as revenue on our income statement.

$1.7 million.

This was lower than the $7.7 million that reported in the first quarter 2019.

Due to lower funding pertaining to Hbr received under sparrows contract Biomedical advanced research and development authority from BARDA.

Due to the timing of qualified can you kind of make archconservatives incurred during the first quarter 2020.

I would also note that the first quarter 2019, including a $3 million upfront payment associated with our Everest in essence license agreement we entered into in January 2019.

In February 2020, we announced in Florida exercised its first contract option right, an additional $15.9 million in committed funding.

This exercise springs to total committed funding under BARDA to 44.1 million to non dilutive funding.

Stephen J. DiPalma: This exercise brings the total committed funding under BARDA to $44.1 million in non-dilutive funding, inclusive of $10 million in funding from the Defense Threat Reduction Agency, or DTRA. For the first quarter of 2020, R&D expenses were $20.4 million compared to $9.5 million for the same period last year. The increase was primarily due to greater spending on the Ontario Pen and HBR programs, partially offset by lower spending on SBIRT 720 and the potentiator platform. While we expect higher R&D expense in 2020 relative to 2019, we would note that our largest single component of R&D expense is the ADAPT-BL Phase III trial, which we initiated in the first quarter of 2019, and for which we expect top-line data in the third quarter of 2020. General and administrative expenses were $4.1 million for the first quarter, compared to $3.9 million for the same period last year. The increase in Q&A expenses was primarily due to increased headcount.

First of all of 10 million and funding from the defense threat reduction ages here 30 30 truck.

For the first part of 2020, R&D expenses were $20.4 million compared to 9.5 million the same period last year.

The increase was primarily due to greater spending on TV pennant Hbr program.

Partially offset by lower spending on SPR 720 in the Potentiator platform.

Well, we expect higher R&D expense in 2020 relative to 2019.

I would note that our largest single component of R&D expenses. These apio phase three trial, which we initiated the first quarter of 29 chain and for which we expect topline data in the third quarter of 2020.

General and administrative expenses were 4.1 million for the first quarter compared to 3.9 million for the same period last year.

The increase in DNA expenses was primarily due to increased headcount.

We continue to expect genetics bench to increase in 2020 relative to 2019.

Primarily due to additional headcount and professional fees and infrastructure required to support tell you kind of hbr.

Let advances towards potential regulatory approval and airport possible launch or take on a much VR.

Our net loss for the quarter ended March 31, 2020 23.3 million.

Stephen J. DiPalma: We continue to expect GA expense to increase in 2020 relative to 2019, primarily due to additional headcount and professional fees and infrastructure required to support Teddy Phenom HBR as it advances towards potential regulatory approval and prepares for a possible launch. Our net loss for the quarter ended March 31, 2020 was $23.3 million, or $1.22 per share, compared to $5.1 million, or $0.29 per share, during the same period of 2019. The increase in net loss was attributable primarily to the increase in the company's activity, mostly related to clinical trials. As of March 31, 2020, Spero had cash equivalents and marketable securities of approximately $88.8 million, which included net proceeds of approximately $29.5 million from our rights offering, which closed on March 5th, 2020.

Or one dollar.

Dollar 22 per share compared to 5.1 million or 29 cents per share.

Temporary and 29 chain.

Increase net loss was attributable primarily to the end creation copies activity, mostly related to the clinical trials.

As of March 31, 2020, Sparrow had cash cash equivalents in marketable securities approximately approximately 88.8 million.

Which included net proceeds of approximately 29.5 million from a rights offering which closed on March 2020.

We continue to estimate targeting cash and investments are sufficient to fund our clinical and business operations into the first quarter of 2021.

Through the filing of and then da 14, you kind of Hbr.

The friendly detailing our financials, including comparisons for the quarters ended March 31, 2020 at March 31, 2019, you should refer to our 10-K filed with the FCC today.

That concludes my review of the Companys financial results I'd like to open the call for questions operator.

Well I'll begin the question answer session, who joined the question Q You made press Star then one and you're talking about.

Tony requested speakerphone. Please pick up you had said before addressing any key.

Your question. Please press Star then too well pause for a moment as Paul is join the queue.

Stephen J. DiPalma: We continue to estimate our existing cash and investments are sufficient to fund our clinical and business operations into the first quarter of 2021 through the filing of an NDA for tabipenem HPR. For further details on our financials, including comparisons of the quarters ended March 31, 2020 and March 31, 2019, please refer to our 10K file at the SEC today. That concludes my review of the company's financial results.

The first question comes from Rita barrel with Cowen. Please go ahead.

Good morning, guys. Thanks for taking my question. Thanks for posting your call. It now so right time since we have so many questions on commercialization for can be TNM as well as NTM. My first question and I'll keep myself to to the first question is how long do you envision.

The sales force the commercial course, clubby Putnam and Ah if you have sort of high level views on.

Unknown Executive: I like that.

Operator: open the call for questions. Operator?

The number of a touch points the commercial call point, the types of dockers, but that would target without course and my follow up question on Southern 20 for NTM could you go into maybe a little more detail into what you're hoping to see from a phase two way.

Operator: Operator. We will now begin the question and answer session. To join the question queue, you may press star then 1 on your telephone keypad. You will hear a tone acknowledging your request. Speakerphone, please pick up your handset before pressing any. If you would like to ask a question, please press star there. For a possible moment, it's college.

Hi, monotherapy can you talk about where you feel the efficacy bar is versus standard of care I'm.

Ritu Subhalaksmi Baral: The first question comes from Ritu Baral, with Cohen, please go ahead. Good morning, guys. Thanks for taking the question. Thanks for posting your call. I think now's the right time since we have so many questions on commercialization for Tebby Penham as well as NTM. My first question, and I'll keep myself to two, is, how are you envisioning the sales force, the commercial force for Tebby Penham?

Just because of into a view of the literature.

Conversion and standard of care has served us very.

Very very wide error bars, depending on which.

Which article you look out and Tolerability has such a big haagen it.

Given that background Where's the bar for your phase two data for 720.

Hi, Richard this is on get thanks, so much for your question you're on your first one on the go to market strategy for heavy 10 am I will pass that question to Kristina Larkin and then I can address your second question on the goals for the the NTM study, so I'll hand, the ball over to.

Ankit Mahadevia: And if you have sort of high-level views on the number of touch points, the commercial call points, the types of doctors that you would target with that force. And my follow-up question on 720 for NTM, could you go into maybe a little more detail on what you're hoping to see from a phase 2a frontline monotherapy? Can you talk about where you feel the efficacy bar is versus standard of care? Just because in the review of the literature, culture conversion and standard of care have sort of very, very wide error bars, depending on which article you look at, and tolerability has such a big part in it. Given that background, where's the bar for your Phase 2a data for 720?

You Christina first.

Thanks on can't hybrid do it's nice to hear your voice.

You know I first of all say that our plan right. Now is that we are doing some market preparation work to commercialize the United States, It's really where our expertise says and we'll look to partner ex U.S.

I think as you know there's a couple of important features about 10 dependent that make our strategy a little different than prior in the microbial launches first Oh, you know the drug will be looked a beep primarily reimbursed outside the hospital. So much of our market preparation work is around the reimbursement landscape Secondly, as you mentioned its best specialists.

Ankit Mahadevia: Hi Ritu, this is Ankit. Thanks so much for your questions. You know, on your first one on the go-to-market strategy for Tebby Penham, I will pass that question to Christina Larkin, and then I can address your second question on the goals for the NTM study. So I'll hand the ball over to you, Christina first.

Just a that primarily would be looking to prescribed this or your raul adjust and that some of the work that we've done already and I think you know the last part is we have done some targeting work around understanding a bit more that where the focus could be for our launch what I would say is that we're going to be looking at taking gets stage approach to our launch.

Christina Larkin: Thanks, Ankit. Hi Ritu.

Christina Larkin: It's nice to hear your voice. First, I'll say that our plan right now is that we are doing some market preparation work to commercialize the United States. It's really where our expertise is, and we'll look to partner with ex-U.S. I think, as you know, there are a couple of important features about tebipenem that make our strategy a little different from prior antimicrobial launches. First, you know, the drug will be reimbursed primarily outside the hospital, so much of our market preparation work is around the reimbursement landscape. Secondly, as you mentioned, the specialists that would primarily be looking to prescribe this are urologists, and that's some of the work that we've done already.

By focusing on our largest valued markets first and then it looking to expand over time I will state that it is a highly concentrated market and our salesforce would potentially be incrementally larger than other into microbial sales teams, but it would still be a very focused launch I would think about it as a very specialists.

Then launch focused on urology and I'd that have a practices with high second line oral used or outpatient Ivy prescribing and high resistance ZIP codes right now the team is actively working on this go to market strategy and we you know simultaneous simultaneous to that.

Christina Larkin: And I think, you know, the last part is that we have done some targeting work around understanding a bit more about where the focus could be for our launch. What I would say is that we're going to be looking at taking a staged approach to our launch by focusing on our largest valued markets first and then looking to expand over time. I will state that it is a highly concentrated market, and our sales force would potentially be incrementally larger than other antimicrobial sales teams, but it would still be a very focused launch. I would think about it as a very specialist-driven launch focused on urology and ID practices that have practices with high second-line oral use or outpatient IV prescribing and high-resistance zip codes. Right now, the team is actively working on this go-to-market strategy, and we, you know, simultaneous to this, are also working on business development discussions. Because of our broader prescriber base, it does broaden our reach for potential future collaborations.

Also working on business development discussions on because of our broader you know prescriber base. It does broaden our reach for potential future collaborations.

And Richard Thanks for the second question on the go the goal will go to market strategy for a far the trust striving for NTM. So Big picture you know, we're taking a stepwise approach to 720 development and the goals of this upcoming phase two study are.

Our several fold.

One as we headed out of phase one you're excited to have a safe and and then well tolerated medicine normal healthy volunteers. The intent of the pace to 28 day study is number one to show the safety PK and Tolerability in NTM patients and secondly is to assess 70.

Money as a single agent for early Microbiological response, and that would be a win for the phase two study would be showing that 720 can drive an early microbiological response, while being safe and well tolerated with good PK relative to placebo, Yeah, I think the standard of care in Jan.

Ankit Mahadevia: And Ritu, thanks for the second question on the goal go-to-market strategy for the trial strategy for NTM. So, you know, big picture, you know, we're taking a stepwise approach to 720 development.

Enroll serves as you note patients in consistently and really the wins for the pay the phase two study showing that 720 on its own can drive a microbiological response, we know that patients that respond.

Michael biologically respond early number one number two is when there isn't the tolerability confounding variable we know that these.

Ankit Mahadevia: And the goals of this upcoming Phase 2 study are several fold. You know, one, as we headed out of Phase 1, we were excited to have a safe and well-tolerated medicine in normal, healthy volunteers. The intent of the Phase 2 28-day study is, number one, to show safety, PK, and tolerability in NTM patients, and secondly, to assess 720 as a single agent for early microbiological response. And that would be, you know, a win for the Phase 2 study would be showing that 720 can drive an early microbiological response while being safe and well-tolerated with good PK relative to placebo. I think the standard of care in general serves, as you note, patients inconsistently. And really, the win for the Phase 2 study is showing that 720 on its own can drive a microbiological response. We know that patients that respond microbiologically respond early, number one. Number two, when there isn't a tolerability confounding variable, we know that these patients feel better as we drive an early microbiological response. So those are the goals of the study.

Patients feel better as we drive an early microbiological response, so those are the goals of the study.

And Mike the biological response, you're talking about like Agger plate culture conversion or is there are different moshe we should be thinking about.

So in will and we'll go into more granularity as the year goes on but we will be looking at different measures of microbiological bird and again, it's a 28 day study. So we'll be looking at the directional change relative to two placebo.

So to the cereal culture conversion that we look at four.

In historical studies may not be is relevant but we're looking for a change in that bacterial burden over overtime.

So some sort of range of culture common units as you as you look and see try to assess the amount of bacteria analog.

That's right that the fundamental thing we're looking for his hands seventwenty at the doses that we believed to be safe well tolerated drive a change in the microbiological burden NTM patients, which is the the critical thing that needs to be done dish to drive a better outcomes for patients.

Is it fair to say that subsequent trials would then be combination therapy trials further exploring that.

Yeah. So we'll we'll continue to to be more granular about how we think about the development pathway going forward.

As we get the the minutes back from the FDA meeting in General we would expect that combination therapy would be a next step but again, it's really critical that we show that 720 can drive an outcome on its own a there really hasn't been agents that have been able to show that consistently in that would be a big win for 720.

Ankit Mahadevia: And microbiological response, are you talking about like agar plate culture conversion, or is there a different measure we should be thinking about?

Ankit Mahadevia: So, and we'll go into more detail as the year goes on, but we will be looking at different measures of microbiological burden. Again, it's a 28-day study, so we'll be looking at the directional change relative to placebo. You know, sort of the serial culture conversion that we look at for, you know, in historical studies may not be as relevant, but we're looking for a change in that bacterial burden over time

Got it thanks for taking all the questions.

The next question comes welcome Chan with Cantor. Please go ahead.

Hi, Thanks for taking my questions. Here first question I had for you is how reimbursement for its heavy pen it'd be different from other antibiotics.

Ankit Mahadevia: to some sort of range of culture forming units as you as you look at them as you try to assess the amount of bacteria in the lungs.

And then do you have any thoughts on pricing just yet if not maybe just qualitative you could speak to how you're thinking about it and the value proposition perspective.

Ankit Mahadevia: That's right. The fundamental thing we're looking for is can 720, at doses that we believe to be safe and well tolerated, drive a change in the microbiological burden of NTM patients, which is the, you know, the critical thing that needs to be done to drive better outcomes for patients.

Then the market opportunity for SPR 720, and T. M can you elaborate a little bit more on that what's on the market currently to treat NTM wherever you fit into the treatment paradigm. Thank you.

Ankit Mahadevia: Is it fair to say that subsequent trials would then be combination therapy trials further exploring that?

Youre welcome Louise and nice to hear from you for the first question.

It's very short answer TV panel is reimbursed outside the hospital either by commercial retail payers or by Medicare part D and that's a very important distinction from many antibiotics that we've looked at historically in an important reason why we see such a broad.

Ankit Mahadevia: So we'll continue to be more granular about how we think about the development pathway going forward as we get the minutes back from the FDA meeting. In general, we would expect that combination therapy would be a next step, but again, it's really critical that we show that 720 can drive an outcome on its own. There really haven't been agents that have been able to show that consistently, and that would be a big win for 720.

Market opportunity.

As it relates to.

Our thoughts on downstream pricing I will hand that question off to Christina and then for your final question as it relates to the standard of treatment for NTM I will hand that question to David So perhaps Kristina you can start with our views on on on the total addressable market and how price fits in.

Operator: The next question comes from Mr. Ted.

Operator: with candor. Please go ahead.

Unknown Attendee: Hi, thanks for taking my questions here. The first question I had for you is, how will reimbursement for Tebipenem be different from other antibiotics? And then, do you have any thoughts on pricing just yet? If not, maybe, just qualitatively, you could speak to how you're thinking about it from the value proposition perspective. And then the market opportunity for SPR 720 and NTM, can you elaborate a little bit more on that? What's on the market currently to treat NTM, and where will you fit into the treatment paradigm? Thank you.

To that.

Yeah, I think as we had mentioned we use that it's about a two two to 3 million patient population that we're looking to treat if you think about that total urinary tract infection. The market in total there is somewhere between 11 to 12 million patients that happy you T.I.s in the United States in total so we're looking to target.

You know still the largest yutai market a in the United States from pricing perspective to get back to your question, we've not yet finalized our pricing research as of yet so I can't definitively give you an answer on the number and it will be certainly be something that will give you a more definitive answer moving forward.

Ankit Mahadevia: You're welcome, Luis, and nice to hear from you. You know, for the first question, it's a very short answer.

Christina Larkin: Tebipenem is reimbursed outside of the hospital either by commercial retail payers or by Medicare Part D, and that's a very important distinction from many antibiotics that we've looked at historically and an important reason why we see such a broad market opportunity. As it relates to our thoughts on downstream pricing, I will hand that question off to Christina, and then for your final question as it relates to the standard of treatment for NTM, I will hand that question to David. So perhaps, Christina, you could start with our views on the total addressable market and how price fits into that.

But I think you know if you look at pastor launches in the anti microbial space in the retail sector. There have been somewhere in a range a that might give you an idea of you somewhere between 350 dollar price all the way you have to somewhere around $500 that gives you an idea.

Oh, Hi, this is David no.

Tom So the current standard of care for the treatment of non tuberculosis might go back through infections.

Christina Larkin: Yeah, I think, as we had mentioned, Louise, that it's about a 2 to 3 million patient population that we're looking to treat. If you think about the total urinary tract infection market in total, there are somewhere between 11 to 12 million patients that have UTIs in the United States in total. So we're looking to target, you know, still the largest UTI market in the United States. From a pricing perspective, to get back to your question, we have not yet finalized our pricing research as yet. So I can't definitively give you an answer on the number, and it will certainly be something that we will give you a more definitive answer moving forward. But I think, you know, if you look at past launches in the antimicrobial space in the retail sector, there have been some in a range that might give you an idea of, you know, somewhere between a $350 price all the way up to somewhere around $500. That gives you an idea.

Consists of prolong combination therapy generally greater than a year.

With generally a three or four drug combination that includes a macrolide referral my son and frequently with a family of toll we're in a minute glycoside.

Because the therapy is complicated and poorly tolerated and because the response rate is not very good with the current standard of care intervention is generally limited to patients who have relatively advanced disease and these patients frequently have fixed lung injury. So that it's hard in this.

Sending a bit tissue injury up to demonstrate.

Substantial clinical benefit.

The plan for.

Tim.

That's pure 720 used to devise a regimen approach that will be a better.

Calibrated and therefore suitable for earlier intervention in non refractory patients who don't have advanced issue under.

David Melnick: Hi, this is David Melnick. In terms of the current standard of care for the treatment of non-tuberculous mycobacterial infections, it consists of prolonged combination therapy for generally greater than a year, with generally a three or a four-drug combination that includes a macrolide, erythromycin, and frequently with thambutol or an aminoglycoside. Because the therapy is complicated and poorly tolerated, and because the response rate is not very good with the current standard of care, intervention is generally limited to patients who have relatively advanced disease, and these patients frequently have fixed lung injuries, so it's hard, in the setting of that tissue injury, to demonstrate substantial clinical benefit. The plan for NTM, for SPR 720, is to devise a regimen that will be better tolerated and therefore suitable for earlier intervention in non-refractory patients who don't have advanced tissue injury.

Okay. Thank you.

The next question comes from Stephen Willey with.

With Stifel. Please go ahead.

[laughter].

Hey, good morning, Thanks for taking my questions and congrats on completing enrollment in a down.

Just just.

And I'm, sorry, I missed this but can you maybe just talk about.

Kind of the.

The trigger that upsize the trial I guess from around 1200 13 70, another there was.

Indicated I think in the prepared comments that there was some assessment of.

The response to the variability rate at the 70% enrollment point, so I guess.

Can you speak to what you needed to see at that point in time and in order to not enrolled what's not upsize the trial.

And then I guess, you know just given some of the coated concerns here, but of course the past few months can you.

Operator: The next question comes from Stephen Wiley with Stiefel. Please go ahead.

Maybe just kind of speak a little bit to your confidence in and a patient follow up here throughout the the the latter part of the trial, specifically your ability to to capture data points and.

Stephen J. DiPalma: Good morning. Thanks for taking the questions and congrats on completing enrollment in the DAP. Unknown Speaker Just Unknown Speaker Just, And I'm sorry if I missed this, but can you maybe just talk about kind of the trigger that upsized the trial, I guess, from around 1200 to 1370. I know that it was indicated, I think, in the prepared comments that there was some assessment of, you know, the response and the valuability rate at the 70% enrollment point. So I guess, Can you speak to what you needed to see at And then I guess, you know, just given some of the COVID concerns here over the course of the past few months, can you maybe just kind of speak a little bit to your confidence in patient follow-up here throughout the latter part of the trial, specifically your ability to capture data points in these patients who are followed up? Thanks.

In these patients that follow.

Thanks.

Steve It's good to hear from your I'll take the second question first you know as we have.

Reiterated our guidance on data delivery, we've taken into account the logistics necessary to fully clean and complete the dataset nothing much as we noted about enrollment.

That really good uses that that we've made considerable progress on that already pre coated and we're very confident going into our third quarter 20 guidance on all of the data question post coated on the second question on a trial size and I will hand that too David and David If you could if you could answer Seans question.

Please.

You bet the change in the total enrollment into the trial was based on a pre planned assessment of the is valued below the rate for the primary analysis population, which is the microbiological I see this was outperformed as defined in the protocol.

Ankit Mahadevia: Steve, it's good to hear from you. I'll take the second question first.

Ankit Mahadevia: You know, as we have reiterated our guidance on data delivery, we've taken into account the logistics necessary to fully clean and complete the data set. And I think, much as we noted about enrollment, the really good news is that, you know, we've made considerable progress on that already pre-COVID. And we're very confident going into our third quarter 20 guidance on the data. So I'm happy to take the question post-COVID. On the second question on trial sizing, I will hand that to David. And David, if you could, if you could answer Steve's question, please.

At the 70% enrollment rate.

Hopeless and we to do this is to ensure that we him.

And adequate number of patients in the primary analysis population to maintain the full statistical powered the study at 9%.

And based on that that analysis, we've decided to top up the study with some additional enrollment to ensure that that was the case.

Okay, that's helpful and.

I guess is we look at you know two six.

It's a little bit I guess kind of disconnected from your I guess, the overarching theme with respect to.

David Melnick: The change in total enrollment into the trial was based on a preplanned assessment of the evaluability rate for the primary analysis population, which is the microbiological ITT. This was performed as defined in the protocol at the 70% enrollment rate, and the purpose, and we routinely do this, is to ensure that we have an adequate number of patients in that primary analysis population to maintain the full statistical power of the study at 90%. And based on that analysis, we decided to top up the study with some additional enrollment to ensure that that was the case.

The finding an avenue to reimburse these drugs outside the hospital et cetera et cetera.

We know that fundings in place there there's obviously.

Medicines I'm on the other partnerships I, but I guess how.

How far do you continue to push.

You are six has that's kind of the Spiro funded program or.

This is just something that you continue till we get unsold funding dries up or.

I would just be kind of curious as to what your thoughts or.

Yeah. Thanks for the question Steve.

We really like the profile of up to about six it's what our team has been able to do is develop a medicine.

Stephen J. DiPalma: Okay, that's helpful. I guess as we look at, you know, 206. It's a little bit, I guess, kind of disconnected from your, I guess, the overarching theme with respect to, you know, finding an avenue to reimburse these drugs outside of the hospital, etc, etc. Um, we know that funding's in place there. There's obviously Everest Medicines on the partnership side, but I guess how far do you continue to push? 206 as a kind of Spero-funded program or, Is this just something that you continue to look at until funding dries up, or would you just be kind of curious as to what your thoughts are?

That has a therapeutic index, but also a broad spectrum that you just don't see inpatient you I you know the prioritization of the of the program and we're very fortunate that both with the National Institutes of how a department of defense and adverse medicines that we're able to advance to rose six beyond.

Phase one into its next clinical studies I think our.

General philosophy until six has always been to work with partners around the world to continue to advance that medicine, just because it's the right thing to do for patients and I'll note that we have a very strong track record across the pipeline of continuing to collaborate on our entire pipeline, whether that's part of what have you kind of them or the gates Foundation with 720.

Ankit Mahadevia: Yeah, thanks for the question, Steve. You know, we really like the profile of 206. It's what our team has been able to do is develop a medicine that has a therapeutic index, but also a broad spectrum that you just don't see in patients. You note the prioritization of the program, and we're very fortunate that both with the National Institutes of Health, Department of Defense, and Everest Medicine, we were able to advance 206 beyond Phase I into its next clinical studies. I think our general philosophy on 206 has always been to work with partners around the world to continue to advance that medicine just because it's the right thing to do for patients. And I'll note that we have a very strong track record across the pipeline of continuing to collaborate with our entire pipeline, whether that's BARDA with Tevi Pennam or the Gates Foundation with 720, as we advance further into the clinic. I'd be, I'd continue to guide that we would have that strategy going forward and continue to work with a variety of partners.

As we advance further into the clinic, so I I'd be I continue to.

To to guide that we'd we'd have that strategy going forward and continue to work with a variety of partners, both private and public around the world to advance to a six.

Got it and it maybe just lastly kind of bigger picture.

Obviously, just given current theres a lot of.

A lot of [noise].

Focus here on on just pandemic preparedness.

Just kind of wondering how you're now thinking about whether or not.

You know co bid in the context of over that concern is is a tailwind or headwind for the antibiotic space.

In the sense that you now have a lot of these.

Agencies, which have historically.

Funded antibiotic development, all really now seem to kind of have there is squarely focused on.

And that makes you see that as being maybe a little bit disruptive to anybody.

Antibiotic funding over the course in the next couple of years or do you think that.

That kinda continues as planned thanks.

Ankit Mahadevia: Got it. And maybe, just lastly, a kind of bigger picture. Obviously.

Yeah, Thank Steve for the question.

Stephen J. DiPalma: Given COVID, there's a lot of focus here on just pandemic preparedness. Just kind of wondering how you're now thinking about whether or not, you know, COVID in the context of that concern is a tailwind or a headwind for the antibiotic space in the sense that you now have a lot of these agencies which have historically funded antibiotic development all really now seem to kind of have their eyes squarely focused on on pandemics. Do you see that as being maybe a little bit disruptive to antibiotics?

At 100000 take we see a major tailwinds.

As we as it relates to the response for close to 19, and there's a couple of layers to that you know the first layer. He is very directly with our particular pipeline.

As we noted earlier in my remarks on now more than ever we are looking for ways to treat you'll patients outside of the hospital whenever possible no. Prior to co that there was financial toxicity as well as the risk of.

No. So camille infections want to patient was admitted they did not need to be and the presence of coated in our hospitals as only amplifier about and we hear from clinicians every day about the necessity of having powerful medicine, where you can treat a patient outside of the hospital. That's that's number one and then as we get to a macro perspective.

Ankit Mahadevia: Antibiotic funding over the course of the next couple years, or do you think that that kind of continues as planned? Thanks.

Ankit Mahadevia: Yeah, thanks, Steve, for the question. At 100,000 feet, we see major tailwinds, you know, as it relates to the response for COVID-19. And there are a couple of layers to that. You know, the first layer is very directly related to our particular pipeline.

I will note a couple of things number one is that in this setting of Covance, specifically secondary infections are an important and dangerous aspect that cobot patients have to deal with I think secondly is now.

It is forcing our society globally to take a look comprehensively at the investments that we need to make to prevent the next future pandemic, because we all know to that future Pandemics would calm and they may not be Corona virus next time and so what we've seen is a comprehensive evaluation of the invest.

Ankit Mahadevia: As we noted earlier in our remarks, now more than ever, we are looking for ways to treat ill patients outside of the hospital whenever possible. You know, prior to COVID, there was financial toxicity, as well as the risk of nosocomial infections when a patient was admitted when they did not need to be. And the presence of COVID in our hospitals has only amplified that, and we hear from clinicians every day about the necessity of having powerful medicine where you can treat a patient outside of the hospital. That's, that's number one.

Ms needed as a society.

To be able to be better prepared for the next pandemic and and in fact, the coded crisis has accelerated those types of discussions you know legislations, such as past youre and disarm or things that have become further amplified and so I would expect a couple of things number one is that you know treating patients outside of the high.

Ankit Mahadevia: And then as we get to a macro perspective, I will note a couple of things. Number one is that, in the setting of COVID, specifically, secondary infections are an important and dangerous aspect of the hospital. And that's an important aspect that COVID patients have to deal with. I think secondly that, you know, it is forcing our society globally to take a comprehensive look at the investments that we need to make to prevent the next future pandemic. Because we all know that future pandemics will come, and they may not be coronavirus next time. And so what we've seen is a comprehensive evaluation of the investments needed as a society to be able to be better prepared for the next pandemic.

Hospital will continue to be more important than ever and number two is when taking a broader macro look at the importance of good infectious disease infrastructure and policymakers are following suit. So it's a very important time for us to be part of that.

I appreciate the response thanks.

The next question comes from Kevin together with Oppenheimer. Please go ahead.

Hi, Thanks for taking my questions and I want to add my thanks for this call. It's very timely for US My first questions on 720.

In the phase one healthy volunteers.

Dose escalation work. It seems you you have a therapeutic window somewhere between.

500, Mags and a thousand should we think about a two way as you likely including you know two dose levels are high and allowed us or do you think of informative to look at more than 2000 sort of within there that that was French.

Kevin Thanks for the question and good to hear from that.

Ankit Mahadevia: And, in fact, you know, the COVID crisis has accelerated those types of discussions; legislation such as Pasteur and disarm are things that have become, you know, further amplified. And so I would expect a couple of things. Number one is that, you know, treating patients outside of the hospital will continue to be more important than ever. And number two is that we're taking a broader macro look at the importance of good infectious disease infrastructure, and policymakers are following suit. So it's a very important time for us to be part of that.

Yes, we will continue to be more granular about the specifics of that broader phase two design as we go in a future public Forum I think for our precedent, we're very confident about the path forward around the broad parameters that we communicated previously and as we get a further.

Our regulatory written guidance, what we'll continue to be more definitive up for now I would say that.

The way that we communicated the treatment doses is the way. We currently plan and we'll continue to refine that in the future public Forum.

Sure no absolutely fair enough and.

There has been some work done in.

For other indications oncology and you know a few others. We've seen a survey work that seems to suggest.

A shift.

Stephen J. DiPalma: I appreciate the response. Thanks. The next question comes from Kevin, together with Oppenheimer. Please go ahead. Hi, thanks for taking my questions. And I want to, you know, add my thanks for this call. It's very timely for us.

And prescribing habits related to covert 19 year from Ivy to appropriate or alternatives. If one thinks about the infectious disease landscape are you familiar with any datasets that they may you know capture more quantitatively what we are hearing anecdotally in terms of aircraft.

Kevin: My first question is on 720. In the Phase I Healthy Volunteers dose escalation work, it seems you have a therapeutic window somewhere between 500 mg and 1,000. Should we think about the 2A as likely including two dose levels, a high and a low dose, or do you think it would be informative to look at more than two doses within that dose range?

Since for oral therapies, recognizing that you know cdti may not be right population to think about tend to capture that kind of.

Data.

Yes, so that Kevin Thanks for the question.

The good news is even pre coded theres, some pretty stark quantitative justification for why it makes sense to try to see utilization the hospital and I'd guide to the listeners of this call to our investor presentation will be quantify the financial toxicity associated with.

Admission when one isn't required it just makes financial sense to do so cold did for no coated in terms of the quantitative ability to review what cold is doing for inpatient admissions that literature is starting to emerge. One example that we know of is outside of cdti and that is a corresponding.

Ankit Mahadevia: Kevin, thanks for the question and good to hear from you. You know, we will continue to be more granular about the specifics of that broader phase two design as we go in a future public forum. I think for our precedent, you know, we're very confident about the path forward around the broad parameters that we've communicated previously. And as we get, you know, further regulatory written guidance, we'll continue to be more definitive. For now, I would say that, you know, the way that we've communicated the treatment doses is the way that we currently plan, and we'll continue to refine that in a future public forum.

It's in a new England journal about the behavior of Italian positions in terms of treating their patients with acute coronary syndrome. So we are seeing emerging in the medical literature that conditions that really have historically been treated them the hospital not being treated there because of the barriers that coded places on both.

Capacity as well as the risk benefit and we'll see that data continue to emerge as well.

Ankit Mahadevia: Sure, no, absolutely fair enough. And Also, There has been some work done in, you know, for other indications, oncology, and, you know, a few others we've seen of survey work that seems to suggest, you know, a shift in prescribing habits related to COVID-19 from IV to appropriate oral alternatives. If one thinks about the infectious disease landscape, are you familiar with any data sets that may, you know, capture more quantitatively what we are hearing anecdotally in terms of a preference for oral therapies, recognizing that, you know, CUTI may not be the right population to think about to capture that kind of data?

Great. Thanks for taking my questions.

The next question comes from a strong with Janney. Please go ahead.

Hi, good morning, Thanks for taking my questions I'm still on heavy Penon hbr, assuming there's positive data on what steps remain before filing the NDA what type of review period do you anticipate and if there's a short review period.

Could we expect a launch next year and then separately on I wanted to ask about a study listed on clinical trials Dot Gov to assess the effect of Americans all on how many panamax PR and specifically the reason behind that study. Thanks.

Thank you Mr. so for the first question I'll I'll note that.

In India package consists of several important components. There are a there is it the phase three pivotal study there are the CMC data and documentation and then there were ancillary studies as you note and with all of that in mind, we continue to reiterate that our guidance around.

Ankit Mahadevia: Yeah, so Kevin, thanks for the question. You know, the good news is even pre-COVID, there's some pretty stark, quantitative justification for why it makes sense to treat a CUTI patient in the hospital. And I'd guide the listeners of this call to our investor presentation where we quantify the financial toxicity associated with admission when one isn't required. It just makes financial sense to do so, COVID or no COVID. You know, in terms of the quantitative ability to review what COVID is doing for inpatient admissions, the literature is starting to emerge. One example that we know of is outside of CUTI. And that is, you know, correspondence in the New England Journal about the behavior of Italian physicians in terms of treating their patients with acute coronary syndrome. So we are seeing in the medical literature that conditions that really have historically been treated in the hospital are not being treated there because of the barriers that COVID places on both capacity as well as the risk benefit. And we'll see that data continue to emerge as well.

Hey, first quarter, 21, and da file consistent with our capital runway.

We are we do have fast track designation and we haven't commented publicly about the pathway to launch beyond there, but with those two pieces in mind.

No there's sort of the a thought process behind that you know as it relates to the specifics of the of the second question I'll, Oh I'll hand, it today the to answer that question about the unique result.

Yes, specifically, we want to ensure that changes in gastric ph will not change.

Change the absorption of tend to kind of HDR from the got the drug is extremely well absorbed as we've mentioned for 60% oral bioavailability, but there has been a prior study looking at the impact of gastric ph.

We stand by our Japanese partner made you say call. It did not show major effect, but we want to confirm that that is the case. So that we can have appropriate labeling.

Kevin: Great, thanks for taking my question. The next question comes from Esther Hong with Janey. Please go ahead. Hi, good morning.

Esther P. Rajavelu: Thanks for taking my questions. So, on tebupenem HBR, assuming there's positive data, what steps remain before filing the NDA? What type of review period do you anticipate? And if there's a short review period, could we expect a launch next year? And separately, I wanted to ask about a study listed on clinicaltrials.gov to assess the effect of omeprazole on tebupenem HBR and specifically the reasons behind that study. Thanks. Thanks, Esther.

We don't think that there will be in entering through but we need to confirm it.

Okay, just asked what that what that data was by Meiji.

Yes, there was a drug drug interaction study that.

Individual administration Tempe Pelham page.

Kim Provoq, Seoul, and oral administration in conjunction with and acids.

And that's study showed only very minor change in the PK of absorption absorbed compared.

Ankit Mahadevia: So for the first question, I'll note that an NDA package consists of several important components. There is the Phase III Pivotal Study, there is the CMC data and documentation, and then there are ancillary studies, as you note, and with all of that in mind, we continue to reiterate our guidance around a First Quarter 2021 NDA filing consistent with our Capital Runway. We do have fast track designation, and we haven't commented publicly about the pathway to launch beyond there, but with those two pieces in mind, there's sort of a thought process behind that. As it relates to the specifics of the second question, I'll hand it to David to answer that question about the ameep result.

With co administration.

We are looking up now.

Yeah.

For can pump antagonists proton pump antagonists.

Great. Thanks.

Well good luck.

The next question is from Rob summarizes this page.

Please go ahead.

Thanks, very much for taking my questions. Firstly on the commercial front I was just wondering if you could perhaps elaborate on the profile of the ideal sales rep that you would want on that type of kind of detail and if you have a sense of whether it would be most appropriate to go with the salesforce.

That.

You know kind of uniformly has prior anti infective promotional experience and if there are specific antibiotic drug.

David Melnick: Yes. Specifically, we want to ensure that changes in gastric pH will not change the absorption of tebupenem HBR from the gut. The drug is extremely well-absorbed, as we've mentioned before, 60% oral bioavailability. There has been a prior study looking at the impact of gastric pH. That was done by our Japanese partner, Meiji Seika. It did not show a major effect, but we want to confirm that that is the case so that we can have appropriate labeling. We don't think that there will be an interaction, but we need to confirm that.

David Melnick: Can I just ask what that data was by MAGIE?

Scribe, then I think that will be both into community and as a drug that will be utilized to get patients home and out of the hospital. So we'll have a place both in the getting patients to go home and stay home and so the ideal representative.

David Melnick: Yes, there was a drug-drug interaction study that looked at individual administration of tepipenum hb, tepipenum parvoxil, and oral administration in conjunction with antacids. And that study showed only a very minor change in the PK of absorption, the absorbed compound, with co-administration. We are looking at now...

While certainly at prior antimicrobial experience is certainly I think a benefit I also think that there is some experience that we could gain from having someone who's had prior experience in neurology offices, which is going to be a primary target for us and having some prior experience and relationships and those offices, which is where we're going to have a very.

David Melnick: See you. Bye, protein pump antagonists, and proton pump antagonists.

Esther P. Rajavelu: Great, thanks.

Operator: The next question is from Ron Soberaji with H-

Operator: See you on the right. Please go ahead.

Unknown Attendee: Please go ahead.

Unknown Attendee: Thanks very much for taking my questions. Firstly, on the commercial front, I was just wondering if you could perhaps elaborate on the profile of the ideal sales rep that you would want on the Tebipenem detail, and if you have a sense of whether it would be most appropriate to go with a sales force that you know, kind of uniformly has prior anti-infective promotional experience. And if there are specific antibiotic drugs that you would in particular be looking for them to have had prior experience with, that you feel would position them most optimally to

Important.

Place for prescribing are drug. So you know is there a prior experience of a product that I would point you to not yet, but I think it's a really great question. We'll certainly give you guys more insights into that profile of a sales representative as we as we proceed towards launch.

[noise], Great and then on 720 I was just wondering if you could provide us with some perspectives on what May lie ahead beyond the fees to weigh assuming the phase two a. is positive for example, if you come out of the phase two away with a very quick answer to the question of what the optimal dose.

Christina Larkin: Do a solid job detailing tebepenem as and when it gets approved. Thank you.

Ankit Mahadevia: Thanks, Ram, for the question. I'm going to hand that question over to Christina.

Christina Larkin: Thanks for the question. So, you know, I think it goes back to where we're looking to see where tevipenem is going to be primarily prescribed. And I think that will be both in the community and as a drug that will be utilized to get patients home and out of the hospital. So we'll have a place both in getting patients to go home and stay home. And so the ideal representative While certainly prior antimicrobial experience is certainly a benefit, I also think that there is some experience that we could gain from having someone who's had prior experience in urology offices, which is going to be a primary target for us, and having some prior experience and relationships in those offices, which is where we're going to have a very important place for prescribing our drugs. So, you know, is there a previous experience Not yet, but I think it's a really great question. We'll certainly give you guys more insights into that profile of a sales representative as we proceed towards launch. Great. And then on 7-20...

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Would you be able to move into something that looks like a pivotal study and if that's the case would you be able to potentially get to the finish line with a single such study or would you need to run two of them just trying to get a sense of what the clinical development path is going to look like for 720 after the stewards. Thanks.

Oh, Thanks wrong for the question you know, they're they're important questions and and you know I would just know too we will be more granular about our thoughts on that as we get the complete written documentation from our discussion you'd regulators and get closer to the beginning of our of our face.

To study.

Okay, then lastly onto a six I just wanted to get additional clarity on whether you expect the Bronx Bronco alveolar bought lovage phase one trial as well as the Reno impairment study to kind of wrap up the phase one stage of development for this age.

Or if you think there's gonna be any additional work that would be needed before you move into sort of more direct assessment of its advocacy profile.

Ram: I was just wondering if you could provide us with some perspectives on what may lie ahead beyond Phase 2a, assuming that Phase 2a is positive.

Yeah, well thanks for the question there as well, it's our expectation that those two trials are the ones necessary as precautions for for patient studies.

Ankit Mahadevia: For example, if you come out of phase 2a with a very clear...

Ankit Mahadevia: A clear answer to the question of what the optimal dose is, would you be able to move into something that looks like a pivotal study? And if that's the case, would you be able to potentially get to the finish line with a single such study, or would you need to run two of them? Just trying to get a sense of what the clinical development path is going to look like.

Thank you.

Bunch of guys you have a question please press star than one.

The next question that from Jason.

Bank of America. Please go ahead.

They are good morning. This is she on for Jason. Thanks for taking my question. It's just a couple quick fall off from the on these heavy penalties three study might be helpful. If he could remind the audience whether these on these trials topics are getting treat it in the in pay.

Ankit Mahadevia: for 720 after Phase 2a. Thanks.

Ankit Mahadevia: Thanks, Ram, for the question. You know, they're important questions. And, you know, I would just note that we will be more granular about our thoughts on that as we get the complete written documentation from our discussions with regulators and get closer to the beginning of our Phase 2 study.

<unk>, Oh patients setting and I guess, a follow up on the <unk> Bon saw have you seen any have you run into any messing for delays in data capture yes. Thank you.

Ram: Okay, and then lastly, on...

Yeah <unk>. Thanks for the question and specifically or you know efficiency improper rational considerations patience or dose slipped heavy pen on H.B.R. in our study as in patients and then they are discharge and then returned back for their follow up visits.

Ram: I just wanted to get additional clarity on whether you expect the Bronx.

Ram: Bronco Alveola Lavage Phase 1 Trial

Ram: Ritu Baral, Esther Rajavelu, Stephen DiPalma, Ankit Mahadevia, Kamal Hamed, and Satyavrat Shukla

Operator: More direct assessment

Ram: A more direct assessment of its efficacy profile.

And on your second question in terms of of data and covert 19, you know we have been fortunate on a couple of fronts. Firstly that a lot of that data capture and collection is behind us and secondly across a 95 central file as cold that's gone on we've been able to work with sites.

Ankit Mahadevia: Yeah, Rob, thanks for the question there as well. It's our expectation that those two trials will be the ones necessary as precursors for patient studies.

Ankit Mahadevia: Thank you.

Operator: Once again, if you have a question, please press star then 1. The next question comes from Jason Gerberi with Bank of America. Please go ahead.

That continued to be open for business and specific jurisdictions and so we're very comfortable as we incorporate all that into our guidance in terms of what will be able to deliver and the third quarter.

Jason Gerberi: Hey, good morning. This is Chi. I'm for Jason.

Unknown Attendee: Thanks for taking my question. It's just a couple of quick follow-up questions from me on the TAVI panel phase 3 study. Might be helpful if you could remind the audience whether

Thank you started helpful. Thank you so much.

Unknown Attendee: Are trial subjects getting treated in the inpatient and outpatient setting? I guess a follow up on the COVID response. Have you seen any, or have you run into any missing or delays?

[noise]. The next question is a reader girl was gone. Please go ahead.

Hey, guys thinks you're taking the follow up just a couple has keeping questions on adapt P.R.

What is the noninferiority margin for the pollen.

Unknown Attendee: Unknown Data Capture. Not yet.

So we we had a a pre phase three meeting with the F.D.A., where we agreed on on a 10% and I Margie.

Ankit Mahadevia: Yeah, thanks for the question. And specifically, for efficiency and for operational considerations, patients are dosed with Tevipenem HPR in our study as inpatients, and then they are discharged and then returned for their follow-up visits. You know, and on your second question, in terms of data and COVID-19, you know, we have been fortunate on a couple of fronts. Firstly, that a lot of that data capture and collection is behind us. And secondly, across a 95 center trial, as COVID's gone on, we've been able to work with sites that continue to be open for business in specific jurisdictions. And so we're very comfortable as we incorporate all that into our guidance in terms of what we'll be able to deliver in the third quarter. Thank you. This is very helpful.

10% goddess and how highs how has compliance.

Well.

I guess with treatment just because it is a a T.I.D. just saying.

So in the context of the trial compliance is excellent because these patients are inpatient.

Were observed as they take their medicine, I I think to the the broader question for acute medications, there's quite a bit of literature of that three times a day administration in compliance is is actually quite good it's as things go to chronic where where others differences between for example, three times a day and twice today.

Got a an unclean you back to 720 for a second can you remind us what the preclinically what that does limiting talks there was and.

Unknown Attendee: Thank you so much.

Operator: The next ques-

The most common.

Ritu Subhalaksmi Baral: The next question is from Ritu Baral with Cohen. Please go ahead.

Colorability effect scene.

Ritu Subhalaksmi Baral: Hey guys, thanks for taking the follow up. Just a couple housekeeping questions on ADAPTPO. What is the non-inferiority margin for the power?

<unk>, what's the most common tolerability effects were seen on the phase one help to volunteer studies.

And thanks, so much for the question I'll, I'll hand that day, but a dancer.

David Melnick: So we had a pre-phase three meeting with the FDA where we agreed on a 10% NIMRG.

Yeah for for.

David Melnick: Got it. And how has compliance been with, I guess, treatment just because it is a TID dosing?

Clinical toxicology studies were done in nonhuman primate and then rent nonhuman primate. It was g. tolerability issues and you know the rat dosing went to.

David Melnick: So in the context of the trial, compliance is excellent because these patients are inpatients and they're observed as they take their medicine. I think that the broader question for acute medications is that three times a day administration is actually quite good as things go to chronic where there are differences between, for example, three times a day and twice a day.

Not free so some of the 31 day G.O.P. study there was some evidence agree like those is renal toxicity and and 'cause.

Ritu Subhalaksmi Baral: Got it. And can you go back to 720 for a second? Can you remind us what the preclinical dose limiting talk was, and what the most common tolerability effects seem to be? What are the most common tolerability effects we're seeing in the Phase 1 Healthy Volunteer Study?

<unk> and hepatic professor.

Got it and then on the in the patients indicates one.

In in Phase one of the drug was quite well tolerated again the side effects were all mild a few moderate intensity no severe or serious adverse events and it was g. on.

David Melnick: Thanks so much for the question. I'll hand that to David.

David Melnick: Yeah, preclinical toxicology studies were done in non-human primate and in rat. In non-human primate, it was GI tolerability issues. And in the rat, dosing went to Unknown Speaker The highest dose in the 31-day GLP study, there was some evidence of very high doses of renal toxicity and a, and Hepatic Effects.

Yeah, again, and N.G.I. that like no, yeah, or vomiting, or diarrhea, and you talk about the grades at all.

In in in the single those it was predominantly nausea and vomiting in multiple grows at those is a thousand milligrams. It was up sabich diarrhea.

And grade sorry, but smiled Marts, India.

David Melnick: Got it. And then in the patients in phase one.

I'm sort of say again please.

The grades you know mild moderate for severe for the <unk> <unk> <unk> <unk> seasonal monitor.

David Melnick: In Phase 1, the drug was quite well tolerated. Again, the side effects were all mild, a few at moderate intensity, no severe or serious adverse events, and it was GI.

No severe got it.

David Melnick: And GI, is that like nausea or vomiting or diarrhea?

Great. Thank you so much.

You're welcome.

[noise] [noise] those concerns the question and answer session.

David Melnick: In the single dose, it was predominantly nausea and vomiting. In the multiple dose, at doses above 1,000 milligrams, it was episodic diarrhea.

The problem is Rebecca was your data I can read either ready closing remarks.

Oh. Thank you operator, we're excited by the progress we've made by the potential that are pipeline has to meet significant met patient means these needs are more pressing than ever in this new normal and I invite everybody to join us at our next.

Ritu Subhalaksmi Baral: and Grace, sorry, but mild, moderate, and severe.

David Melnick: I'm sorry; say it again, please.

Ritu Subhalaksmi Baral: The grades, you know, mild, moderate, or severe for the

Web cast for presentation, we'll we'll elaborate further in public Forum and that is the bank of America Conference on May 13th at one PM and thanks. So much again for your thoughtful questions and please contact us for any follow up.

David Melnick: [inaudible] No severe.

Ritu Subhalaksmi Baral: Got it.

David Melnick: Great, thank you so much. You're welcome.

Ankit Mahadevia: This concludes the question and answer session. I would like to turn the conference back over to Dr. Ankit Mahadevia for any closing remarks.

Operator: Oh, thank you, Operator. We're excited by the progress we've made and by the potential that our pipeline has to meet significant unmet patient needs. These needs are more pressing than ever in this new normal, and I invite everybody to join us at our next webcast presentation where we'll elaborate further in a public forum, and that is the Bank of America conference on May 13 at 1pm. And thanks so much again for your thoughtful questions, and please contact us for any follow-ups.

<unk>.

Concludes today's conference call you might disconnect alliance. Thank you for participating and have a present day.

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Operator: This concludes today's conference call. You may

Operator: Disconnected Lines, thank you for participating and have a pleasant day.

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