Q1 2022 Spero Therapeutics Inc Earnings Call

Good afternoon, and welcome to the Spanish do repute excuse this quarter of 20 <unk> financial results Conference call.

Operator: Good afternoon, and welcome to the Spero Therapeutics first quarter of 2022 financial results conference call. At this time, all participants are in the Sononi mode. Following the company's formal remarks, we will open up the call for questions. Please be advised that this call is being recorded, and a replay will be available.

Operator: You can find information on the replay and further information related to today's announcement on the Spero Therapeutics website at www.spero.org. com. At this time, I would like to turn the conference over to Mr. Ted Jenkins, Vice President, Industrial Relations at Spero Therapeutics. Mr. Jenkins, please go ahead.

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

Following the Companys formal remarks, we'll open up the call for questions.

Please be advised that this call is being recorded and a replay will be available.

You can find information on the replay in Turkey information related to todays announcements.

Under Spiro COPD suite site at Www Dot spirit <unk> Dot com.

At this time I would like to turn the conference is achieved.

Jenkins, Vice President Investor Relations at Spirit Therapeutics, Mr. Jenkins. Please go ahead.

Thank you operator, and thank you all for participating in today's conference call. This afternoon, Spero Therapeutics released financial results and provided a pipeline update for the first quarter of 2022.

Ted Jenkins: Thank you, operator. And thank you all for participating in today's conference call. This afternoon, Spero Therapeutics released financial results and provided a pipeline update for the first quarter of 2022. Our press release is 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, including statements about the potential review status and prospects of approval for Tevipenem HBR and the timing thereof, potential value of Tevipenem HBR, if approved, and the prospects of partnership and or other opportunities for the Tevipenem HBR program, the plans for the company's ongoing development of SVR 720 and SVR 206, The Design, Initiation, Timing, Progress, and Results of the Company's Preclinical Studies and the Clinical Trials and its Research and Development Programs, Management's Assessment of the Results of such Preclinical Studies and Clinical Trials, the Company's Cash Forecasts and Anticipated Expenses, and the Sufficiency of its Cash Resources. Such forward-looking statements are not a guarantee of performance, and the company's actual results could differ materially from those contained in such statements.

Our press release is available on the Investor Page Spero Therapeutics website.

Before we begin I would like to remind you that some of the information contained in the news release and on this conference call contains forward looking statements based on our current expectations, including statements about potential review status and prospects of approval for <unk> and the timing thereof.

Ted Jenkins: Several factors that could cause or contribute to such differences are described in detail in Spero Therapeutics' filings with the SEC, including in the Risk Factors section of our annual report on Form 10-K, filed on March 31, 2022. These forward-looking statements speak only as of the date of this conference call, and the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the company after the date of today's release and call.

So value until you kind of <unk>, if approved and the prospects of partnership and where other opportunities from time to time H B R program.

The plants the company's ongoing development of Spi 2020, and SBR two of six <unk>.

The design initiation timing progress and results of the company's preclinical studies and clinical trials research and development programs Managements assessment of the results of preclinical studies and clinical trials, the company's cash forecast and anticipated expenses and the sufficiency of cash resources such forward looking statements are not a guarantee of performance and the company's actual results could differ materially.

From those contained in such statements several factors that could cause or contribute to such differences are described in detail in sparrow therapeutics filings with the SEC, including in the risk factors section of our annual report on Form 10-K filed on March 31 2022.

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

Ted Jenkins: This is the end of this conference call, and the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the company after the date of today's release and call. Participating in today's call are Dr. Amkit Mahadevia, Chief Executive Officer, Dr. David Melnick, Chief Medical Officer, and Sat Shukla, our Chief Financial Officer. And with that, I'd like to turn the call over to Dr. Amkit Mahadevia. Please go ahead, Amkit.

Participating in today's call are Dr. I'll get my DVS, Chief Executive Officer, Dr. David Melnick, Chief Medical Officer.

She's our chief Financial Officer.

And with that I'd like to turn the call over to Dr. I've kept my idea. Please go ahead okay.

Thank you Ken and thanks to all who have joined US for our earnings call today and as many of you know we recently hosted an update call to discuss our new strategic direction and decision to restructure the company and as difficult as that was we are pleased to be sharing our path forward with you today.

Ankit Mahadevia: Thank you, Ted, and thanks to all who have joined us for our earnings call today. As many of you know, we recently hosted an update call to discuss our new strategic direction and decision to restructure the company. As difficult as that was, we are pleased to be sharing our path forward with you today. To recap our recent news, feedback from an FDA late-cycle meeting, which took place at the end of April, suggested the data from Tebipenem HBR's new drug application may be insufficient to support approval during this review cycle. This led us to make the extremely difficult decision of having to suspend commercial notation activities for Tebipenem HBR and reduce our workforce by approximately 75%.

To recap our recent news feedback from E and F. D. A late cycle meeting, which took place at the end of April suggests that the data from Tami tenant <unk>, new drug application may be insufficient to support approval. During this review cycle and this allowed us to make the extremely difficult decision of having to suspend commercialization activities for can be kind of H B R.

And reduce our workforce by approximately 75%, while we wait for agency guidance on the path forward for it to be kind of an H B R. We have shifted our focus and resources to development activities for each program in our pipeline.

Ankit Mahadevia: While we wait for agency guidance on the path forward for Tebipenem HBR, we have shifted our focus and resources to development activities for each program in our pipeline. For those interested in hearing about the specifics behind FDA's view of the Temp-dependent HPR NDA, I suggest you listen to the replay of our May 3rd conference call, which is available on our website. The primary purpose of today's call is to discuss Spero's position for the future in our efforts to bring medicines to patients with unmet needs. We have three key objectives to create value, which drive our optimism.

For those interested in hearing about the specifics behind the Fda's view of the H B R. A N D. A I suggest you listen to the replay of our May 3rd conference call, which is available on our website.

The primary purpose of todays call is to discuss house sparrows position for the future and our efforts to bring makes your medicines to patients with unmet need.

We have three key objectives to create value, which drive our optimism.

Is it to achieve key clinical and regulatory milestones in our pipeline within our capital runway.

Ankit Mahadevia: The first is to achieve key clinical and regulatory milestones in our pipeline within our Capital One model. Second, is to clarify and execute on the path forward for Tevye Pennan, including through potential collaborations. And finally, is to execute on those milestones, employing good stewardship, capital, and creative partnerships to build a company that has been a hallmark of ours. Our first objective is to execute on our late-stage pipeline, which includes two Phase II-ready assets beyond Febipenem, namely SPR 720 and SPR 206.

Second is to clarify and execute on the path forward for <unk>, including through potential collaborations and finally is to execute on those milestones employing good stewardship of capital and the creative partnerships to build a company, which had been a hallmark of our history.

Our first objective is to execute on our late stage pipeline, which includes two phase two ready assets beyond 70 panel, namely SPR 720 N S. C O to O six Mrs ensures the company's outlook is not tied to any single event and positions us to achieve important clinical and regulatory milestones with a regular cadence.

Ankit Mahadevia: This ensures the company's outlook is not tied to any single event and positions us to achieve important clinical and regulatory milestones with a regular cadence. In this endeavor, we are supported by established partnerships with premier organizations, including Pfizer, Everest Medicine, the Department of Defense, and the National Institute of Allergies and Infectious Disease. These relationships have enabled us to work with some of the world's most established thought leaders in the antibiotic space, as well as provided avenues for additional funding.

In this endeavor, we are supported by established partnerships with premier organizations, including Pfizer adverse Medicine Department of defense and the National Institute of Allergies and infectious disease.

These relationships have enabled us to work with some of the world's most established thought leaders in the antibiotic space as well as providing avenues for additional funding.

For example, our relationships are allowing us to entirely fund the S. P O to O six program through phase two from external non dilutive sources.

Ankit Mahadevia: For example, our relationships are allowing us to entirely fund the SPR-206 program through Phase II from external non-dilutive sources. This, in turn, has helped us provide us with a cash runway that is expected to take us through multiple potential inflection points, including interim data from SPR 720's Phase 2 program in 2023. David will speak more about these deliverables during his portion of the call.

In term.

I'll just provide us with a cash runway, but is expected to take us through multiple potential inflection points, including interim data from S. P. R 700, Twenty's phase II program in 2023, David will speak more about these deliverables during his portion of the call.

Our second objective is to build a path forward for <unk>.

Ankit Mahadevia: Our second objective is to build a path forward for Tebby. It's important to note that our view of Tebby Penham HBR's value proposition has not changed. Tevye Phenom, HBR, has patent life extending into at least 2038. It's been granted Qualified Infectious Disease Product or QIDP status that confers 10 years of market exclusivity and has a robust clinical data set of support. This data set extends far beyond the clinical studies carried out by Spero as a granular formulation of tebupenem has been approved and marketed in Japan for over 10 years. In total, over a dozen studies evaluating tebupenem's efficacy have been conducted, plus a dozen more specifically designed to evaluate tebupenem's pharmacokinetic profile.

It is important to note that our view of kind of an H V r's value proposition has not changed.

H P R.

It has patent life extending into at least 2038, it's been granted qualified infectious disease product or <unk> status can first 10 years of market exclusivity and has a robust clinical dataset of support this dataset extends far beyond even the clinical studies carried out by scale is a granular formulation with epipen was been approved in the market.

And in Japan by your partner Meiji Shakeup for over 10 years in total over a dozen studies evaluating every pet ends up because he had been conducted plus it doesn't more specifically designed to evaluate <unk> patents pharmacokinetic profile. Many of these studies are summarized in a peer reviewed paper published in drug profile and another are adapt P. O study.

Ankit Mahadevia: Many of these studies are summarized in a peer-reviewed paper published in Drug Profile, and another, our ADAPT-PO study, has recently been published in the New England Journal of Medicine. Additionally, extensive post-marketing surveillance of tevipenem with nearly 4 million patients has been conducted in Japan. Thanks to all these data collection efforts, we have an extraordinarily thorough understanding of tebupenem's safety and pharmacologic profile, which gives us confidence in Tebby's ability to potentially address the pressing needs of the NMETs posed by the increasing prevalence of fluoroquinone-resistant and ESBL-producing gram-negative bacteria.

As recently published in the New England Journal of Medicine.

Additionally, extensive post marketing surveillance with heavy pattern with nearly 4 million patients has been conducted in Japan.

Thanks to all these data collection efforts, we have an extraordinarily thorough understanding of public safety and pharmacologic profile. This gives us confidence in <unk> ability to potentially address the pressing unmet needs posed by the increasing prevalence of fluoroquinolones resistant and yes, they are producing gram negative bacteria.

Other considerations would be potential positive impact of providing these patients with an effective oral treatment, which could deliver substantial value to payers physicians and patients. We thus remain confident the tami tenants will provide us with an important and complementary source of value as we explore strategic partnerships and other ways to enable its advancement in a cap.

Ankit Mahadevia: Other considerations would be the potential positive impact of providing these patients with an effective oral treatment which could deliver substantial value to payers, physicians, and patients. We thus remain confident that Tempe Tenant will provide us with an important and complementary source of value as we explore strategic partnerships and other ways to enable its advancement in a capital efficient manner. We are no longer preparing for Tevye Penham's immediate commercialization.

Little efficient manner.

Though we are no longer preparing for TV panels immediate commercialization, we do firmly believe there's a path forward for <unk> Pan am to a potential FDA approval in.

Ankit Mahadevia: We do firmly believe there is a path forward for Tevye Penham to potential FDA approval. In 2022, we are focused on gaining clarity on the requirements for Tebby's ultimate approval through our interactions during this current review cycle and through interactions with the agency after the review cycle. Furthermore, we are focused, as we map that path out, on working with our existing partners and potential new partners on the path to create value for Spero through Tebby Penham.

In 2022, we are focused on gaining clarity on the requirements for Kirby Tandem's ultimate approval through our interactions on this current review cycle and through interactions with the agency asking it would be a cycle. Further we are focused as we mapped that pop out on working with our existing partners and potential new partners on the path to create value for sterile through to be caught up.

Finally, we aim to be good stewards of capital as we deliver on these important value creation points.

Ankit Mahadevia: Finally, we aim to be good stewards of capital as we deliver on these important value creation points. A major driver for making the difficult decision to halt commercialization without delay was to preserve capital necessary to deliver value for shareholders. We aim to do this as we always have through prudent management of our operations and through the types of creative partnerships and collaborations that have been a part of our history. With that, I'll now hand the call over to David to talk about our development plans for SPR 720 and SPR 206. Thank you, Ankit.

A major driver of making the difficult decision to halt commercialization without delay.

It was to preserve capital necessary to deliver value for.

And for shareholders.

We aim to do this as we always have through prudent management of our operations and through the types of creative partnerships and collaborations that had been a part of our history.

With that I'll now hand, the call over to David to talk about our development plans for STR, Southern 'twenty and STR to all six.

Yeah.

Thank you RK let.

David Melnick: Let me start with an overview of SPR-720, our novel oral antibiotic candidate that is being developed as therapy for non-tuberculous mycobacterial pulmonary disease, or NPM-PD. Estimates indicate that there are approximately 130,000 NPM patients across the U.S. and Europe. The bacteria causing NTMPD are commonly found in soil and water.

Let me start with an overview of S. P. R. Seven 'twenty our novel oral antibiotic candidate that is being developed this therapy for non curriculum, Michael bacteria, Mycobacterium pulmonary disease, where N P. M. P D.

Estimates indicate that there were approximately 130000 MTM patients across the U S and Europe .

Bacteria, causing N T. M. P. D are commonly found in soil and water.

David Melnick: Though the majority of individuals will not become infected when exposed to these bacteria, those who have underlying lung disease, a weakened immune system, or are of advanced age are more susceptible. This disease has orphan status, which supports SPR-720's orphan drug designation from the FDA. For those who do become infected, care will typically begin with bronchial hygiene, an exercise program, and educational routines. Unfortunately, in the absence of effective antibiotic treatment, many of these patients will develop progressive lung disease due to chronic infection and inflammation.

The majority of individuals will not become infected when exposed to these bacteria, those who have underlying lung disease, a weakened immune system or or or or advanced age or more susceptible.

<unk> has orphan status, which supports S. P. R. Seven twenties orphan drug designation from the FDA.

For those who do become infected care will typically begin with bronchial hygiene and exercise program and educational routines. Unfortunately in the absence of affective antibiotic treatment. Many of these patients will develop progressive lung disease due to chronic infection and inflammation.

Early intervention before serious lung injury has occured may prevent or delay disabling symptoms caused by the infection.

David Melnick: Early intervention before serious lung injury has occurred may prevent or delay disabling symptoms caused by the infection. However, the risk-benefit profiles of the existing treatment regimens for these patients are poor. These regimens typically involve off-label combinations of three or more antibiotics that are often associated with tolerability and toxicity issues that limit the ability of patients to remain on treatment. These issues are heightened when you realize that current therapy is generally administered on a continuous basis for one to two years and frequently does not prevent patients from progressing to treatment-refractory infections and end-stage lung disease. As a result, these patients have chronic debilitating symptoms that can affect their ability to perform daily activities, including traveling, shopping, or even walking.

Unfortunately, the risk benefit profile, so the existing treatment regimens for these patients support these.

These regiments typically involve off label combinations of three or more antibiotics that are often associated with tolerability and toxicity issues that limit the ability of patients to remain on treatment.

These issues are heightened when you realize that current therapy is generally administered on a continuous basis for one to two years and frequently does not prevent patients from progressing to treatment refractory infections and end stage lung disease. As a result, these patients have chronic debilitating symptoms that can affect that.

Affect their ability to perform daily activities, including traveling shopping or even walking.

So it's an urgent need for improvements to the current standard of care, both in terms of efficacy and Tolerability.

Given the irreversible nature of the anatomical damage caused by this chronic lung inflammation. We are developing S. P. R 720 to treat those patients who are treatment naive or treatment inexperienced at present, the poor tolerability of the standard of care treatment regimens for N. P. M. P D off.

David Melnick: There is such an urgent need for improvement to the current standard of care, both in terms of efficacy and tolerability. Given the irreversible nature of the anatomical damage caused by this chronic lung inflammation, we are developing SDR 720 to treat those patients who are treatment naive or treatment inexperienced. At present, the poor tolerability of the standard of care treatment regimens for NTMPD often causes patients and their physicians to delay intervention until the onset of disabling symptoms related to lung tissue injury.

And causes patients and their physicians to delaying intervention until the onset of silly disabling symptoms related to lung tissue injury.

The introduction of well tolerated oral agents would potentially support earlier intervention with the goal of decreasing bacterial burden and thus progressive lung damage.

David Melnick: The introduction of well-tolerated oral agents would potentially support earlier intervention with the goal of decreasing bacterial burden and thus progressive lung damage. By intervening at this early stage and with SPR720's novel mechanism of action targeting bacterial DNA replication, our objective is to prevent the progression to refractory disease and permanent lung damage that comes with it. We believe this is the best strategy to improve patient outcomes and quality of life, particularly when compared to agents that are designed only for those with late-stage treatment refractory disease.

The intervening at this early stage and with S. P. R. Seven <unk> novel mechanism of action targeting bacterial DNA replication. Our objective is to prevent the progression through refractory disease and permanent lung damage that comes with it.

We believe this is the best strategy.

To improve patient outcomes and quality of life, particularly when compared to the agents that are designed only for those with late stage treatment refractory disease.

Our efforts here are supported by a strong data set that demonstrates S. P. R. Seven twenty's potential to provide MTM pulmonary disease patients with a convenient and well tolerated oral therapy.

David Melnick: Our efforts here are supported by a strong data set that demonstrates SPR720's potential to provide MTM pulmonary disease patients with a convenient and well-tolerated oral therapy. Preclinical studies have demonstrated its potent activity against the most prevalent NTM species, both as monotherapy and in combination with other antibiotics.

Preclinical studies have demonstrated potent activity against the most prevalent N T M species, both as monotherapy and in combination with other antibiotics.

In phase one single and multiple sending dose studies S. P. R. Seven 'twenty was shown to be well tolerated at doses that achieved exposures above the predicted therapeutic levels.

David Melnick: In Phase I single and multiple ascending dose studies, SPR720 was shown to be well tolerated at doses that achieved exposures above the predicted therapeutic levels. We are now working to initiate a dose-ranging, placebo-controlled Phase II monotherapy study designed to evaluate SPR720's ability to drive an early microbiologic response in NTM PD patients monotherapy. We expect the trial to begin later this year and to report interim and top-line data in 2023 and 2024, respectively. A demonstration of SPR720's single-agent activity would be a significant de-risking event for this program.

We are now working to initiate a dose ranging placebo controlled phase two monotherapy study designed to evaluate S. P. R. Seven twenty's ability to drive an early microbiological response in N T M. P D patients as monotherapy.

We expect the trial to begin later this year and to report interim and top line data in 2023 and 2024, respectively.

A demonstration of SPR seven twenties single agent activity would be a significant derisking event for this program.

David Melnick: This data, along with the safety, PK, and patient-centered clinical outcomes we will measure, will set the stage for the molecule's long-term development as a component of an effective and well-tolerated oral combination regimen. I'll conclude my portion of today's call with a brief discussion of SPR-206, our novel intravenously administered polymyxin antibiotic candidate that we are advancing toward a Phase II cross-indication resistant pathogen study with the support of multiple partners, including Pfizer, Everest Medicines, the Department of Defense, and NIAID.

It is important as anti microbial activity is the driver of an antibiotics ability to improve patient outcomes.

This data along with the safety PK and patient centered clinical outcome measure will set the stage for the molecules long term development as a component of an effective and well tolerated oral combination regimen.

I'll conclude my portion of today's call with a brief discussion of S. P. R. Two O six our novel Intravenously administered polymyxin antibiotic candidate that we're advancing toward a phase two cross syndication resistant pathogen study with the support of multiple partners, including Pfizer Everest.

Medicines, the department of Defense and N I E I D.

This study will enroll patients with complicated urinary tract infections and hospital acquired and ventilator associated bacterial pneumonia as well as bloodstream infections.

David Melnick: This study will enroll patients with complicated urinary tract infections and hospital-acquired and ventilator-associated bacterial pneumonia as well as bloodstream infections. We believe SPR206 is differentiated from other polymyxins given its potentially enhanced activity against extensively drug-resistant gram-negative pathogens, but importantly, by an improved safety profile highlighted by SPR206's lack of nephrotoxicity over 14 days of treatment in the multiple ascending dose clinical Associated nephrotoxicity is a major shortcoming of the polymyxins currently in use. These are usually prescribed as part of combination antibiotic regimens to patients with serious drug-resistant infections, including those caused by multidrug-resistant Acinetobacter, carbapenem-resistant pseudomonas, and carbapenemase-producing enterobacterioles.

We believe S. P. R. Two of six is differentiated from other poly makes sense given its potentially enhanced activity against extensively drug resistant gram negative pathogens, but importantly by an improved safety profile highlighted by S. P. R. Two essex's lack of nephrotoxicity over 14 days of <unk>.

Treatment in the multiple ascending dose clinical study.

She had a different toxicity is a major shortcoming of the polymyxin currently in use.

These are usually prescribed as part of combination antibiotic regimens to patients with serious drug resistant infections, including.

Including those caused by multi drug resistant acinetobacter, cobre, Panama resistant Pseudomonas and carbo panamax producing enterobacter alleys.

Our goal is to provide an alternative to these older polymyxin in this treatment paradigm, thus improving the risk benefit profile for patients.

David Melnick: Our goal is to provide an alternative to these older polymixins in this treatment paradigm, thus improving the risk-benefit profile for patients. We have developed compelling preclinical and clinical data that support our efforts to move toward this goal. These data were discussed on our update call a few weeks ago and include in vitro results and the results of animal infection models showing SPR2S6's enhanced efficacy compared to traditional antibiotics when directed against these extensively drug-resistant gram-negative pathogens. They also include data from phase one trials that demonstrated the favorable tolerability profile of SPR2S6 and the lack of nephrotoxicity of the agent at predicted therapeutic dose levels.

We have developed compelling preclinical and clinical data that support our efforts to move towards this goal.

Is that it would discuss on our update call a few weeks ago and include in vitro results and the results of animal infection models, showing SPR two of essex's enhanced efficacy compared to traditional antibiotics when directed against these extensively drug resistant Gram negative pathogens. They also include data from phase.

There's one trials that had demonstrated.

The favorable tolerability profile of SBR to a sex and the lack of nephrotoxicity the agent at predicted therapeutic dose levels, we announced the results of one of these trials just this past quarter. The Bronchoalveolar Lavage study, which showed S. P. R. Two of six to be well tolerated with one exposure.

David Melnick: We announced the results of one of these trials just this past quarter, the bronchoalveolar lavage study, which showed SPR2S6 to be well tolerated with lung exposures that remained above the minimum inhibitory concentration of the target pathogens for the entire duration of the anticipated eight-hour dosing interval. Informed by these data, as well as by the results of our recently completed renal impairment study, we are now working to finalize the design of our phase two cross-indication resistant pathogen study.

Or has that remained above the minimum inhibitory concentration of the target pathogens for the entire duration of the anticipated eight hour dosing interval.

Informed by these data as well as by the results of our recently completed renal impairment study. We are now working to finalize the design of our phase two cross indication resistant pathogen study, we have a pre IMD meeting with the FDA scheduled for later this quarter to discuss these efforts.

David Melnick: We have a pre-IND meeting with the FDA scheduled for later this quarter to discuss these efforts, and we expect to initiate the study in the second quarter of 2023. I'll now pass things over to our CFO, Saf Shukla, for a discussion of our recent financial results and cash position. Thank you, David. As of March 31, 2022, the company had approximately $122 million in cash, cash equivalents, and marketable securities.

We expect to initiate this study in the second quarter of 2023.

I'll now pass things over to our CFO Seth Shukla for a discussion of our recent financial results and cash position SaaS.

Thank you David.

As of March 31, 2022, the company had approximately $122 million in cash cash equivalents and marketable securities.

Given the cost savings expected from our restructuring and the cessation of Covid pandemic H B O S commercial activities.

Sat Shukla: Given the cost savings expected from our restructuring and the cessation of Chaby Penham HBR's commercial activities, we believe our existing cash, cash equipment, and marketable security, together with other non-dilutive funding commitments, will be sufficient to fund our planned operating expenses and capital expenditures through late 2020. This cash from the forecast includes the assumption that the amounts under the company's revenue interest financing agreement with healthcare royalty partners will be in repayment. I should also note that this estimated runway does not account for any potential proceeds that may be received from a future sale or license of the Terrapenem HVR program.

We believe our existing cash cash equivalents and marketable securities.

Together with other non diluted funding commitments there'll be sufficient.

To fund our planned operating expenses and capital expenditures through late 2023.

This gas suddenly forecast includes the assumption that the amounts under the company's revenue interest financing agreement with healthcare royalty partners there'll be in repayment.

I should also note that this estimated runway does not account for any potential proceeds that may be received.

From a future sale or license of the H.

The <unk> program.

Importantly, we expect our anticipated cash Sunday to take us through key clinical milestones for both S. P. R 720 N S. P O to O six.

Sat Shukla: Importantly, we expect our anticipated GASH runway to take us through key clinical milestones for both SPR720 and SPR207. Before providing the rest of our first quarter financial results, I'll note that these obviously reflect a period of time prior to our decision to restructure. We therefore expect our total spend to decrease substantially in the quarters ahead.

Yeah.

Before providing divest of our first quarter financial results.

Note that these obviously reflect a period of time prior to our decision to restructure.

We therefore expect our total spend to decrease substantially in.

The quarters ahead.

Total revenues for the first quarter of 2022 were $2 1 million compared with revenues of $10 3 million in the first quarter of 2021.

Sat Shukla: Total revenues for the first quarter of 2022 were $2.1 million, compared with revenues of $7.3 million in the first quarter of 2021. The revenue decrease was primarily due to a decrease in qualified expenses incurred under the BARDA contract for terapenem HPR and a decrease in funding under the NIAID agreement related to SPR-206, partially offset by an increase under the DOD agreement relating to SPR 206 and an increase in collaboration revenues related to the Pfizer agreement.

The revenue decrease was primarily due to a decrease in qualified expenses incurred under the BARDA contract can be Pan am H B O S.

And a decrease in funding under the <unk> agreement related to S. P O to O six.

Partially offset by an increase under the <unk> agreement relating to S. P O to O six.

And an increase in collaboration revenues related to the Pfizer agreement.

Yeah.

Research and development expenses for the first quarter of 2022 was 17 million compared with $18 4 million of research and development expenses for the same period in 2021.

Sat Shukla: Research and development expenses for the first quarter of 2022 were $17 million compared with $18.4 million for the same period in 2021. This year-over-year decrease was primarily due to the completion of significant activities to support the NGA for Cherry Plenum HVR.

This year over year decrease was primarily due to the completion of significant activities to support the NDA for <unk>.

The phase II clinical hold for S. P. R 720, offset by direct cost related to the Spi two of six program and.

Sat Shukla: The Phase II clinical hold for SPR720, although offset by direct costs related to the SPR 206 program and an increase in personnel-related costs. General and administrative expenses for the first quarter of 2022 of 15.3 million were higher than the 8.3 million reported for the same period in 2021, primarily due to an increase in headcount in our commercial, general, and administrative functions.

And an increase in personnel related costs.

General and administrative expenses for the first quarter of 2022 of.

$15 3 million or <unk>.

Higher than the $8 3 million reported in the same period in 2021.

Primarily due to an increase in head count.

Commercial general and administrative functions.

We reported a net loss for the first quarter ended March 31 2022.

Sat Shukla: We reported a net loss for the first quarter ended March 31, 2022, of $32.8 million, or $1.01 per common share, compared to a net loss of $19.4 million, or 66 cents per common share reported for the same period in 2021. For further details on the financials, please refer to our Chen Q filing with the FTC today. We would now like to open the call for questions. Operator.

$32 $8 million.

One point or $1 per common share compared to a net loss of $19 4 million or 66 cents per common share reported for the same period in 2021.

For further details on our financials. Please refer to our 10-Q filed with the SEC today.

We would now like to open the call for questions.

Operator.

Thank you Chad.

Operator: Thank you, sir. Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star then 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue.

Ladies and gentlemen, we will now be conducting a question and answer session.

Also a question. Please press star one on your telephone keypad.

Information tone will indicate that your line is in the question queue.

You May please talk to you and asking the question queue.

Operator: You may press star 2 if you would like to leave the question queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. The first question comes from Louise Chen of Canter. Hi, thank you for taking my question. So, my first question is, have you started having these partnership discussions that you have been talking about, and could we see something this year, especially in the future?

For participants using speaker equipment. It may be needed. So we can pick up your handset before pressing just talkies.

The first question comes from Louise Chen of Ken Chad.

Operator: And then, is adding additional products to your pipeline on the table? How do you think about that? And the last question, and this is a hard question, but how should we think about OPEX for the remainder of 2022? Any guidelines you could provide would be very helpful.

Hi, Thank you for taking my questions here. So my first question is have you started having these partnership discussions that you have been talking about and could we see something this year or is this more of a 'twenty 'twenty three event.

And then is adding additional products to your pipeline on the table. How do you think about that and then last question. It was hard question, but how should we think about opex for the remainder of 2022 any guidelines you can provide would be very helpful. Thank you.

Okay.

Sorry, I cannot confirm Louise Chen.

Yes, Thank you Sir.

Ankit Mahadevia: I appreciate the questions, Louise. So I'll answer the first two and give the last one to Saad. So on the first question, we're always conducting partnership discussions across the portfolio. Those discussions will continue. We have a few key steps as we continue those partnership discussions. One is to progress those discussions. Second, we will continue our discussions with the agency both during this review cycle and after the review cycle to continue to build clarity on the right path forward for Tevipenem.

I appreciate the questions Louise So I'll answer the first two and didn't get the last one Scott. So on the first question, we're always prosecuting partnership discussions across the portfolio.

Those discussions will continue we have a few key steps as we continue those partnership discussions one is to progress those discussions second is to continue our discussions with the agency. Both on this great view cycle and after that review cycle to continue to build clarity on the right path forward for <unk> panel.

The continuing discussions and that information from the FDA. During this calendar year I will give us a strong sense of.

Ankit Mahadevia: Both the continuing discussions and that information from the FDA during this calendar year will give us a strong sense of whether there's a right deal for us to do, and we'll look ahead to that. In terms of adding additional programs, our first step is to really focus on those first three objectives as a first step, and as a reminder, number one, that's executing on delivering key milestones. Second, is finding the right path forward for Tebby, and third, is being good stewards of capital.

Whether there's a right deal for us to do and we'll look ahead to that.

In terms of adding additional programs. Our first step is to really focus on those first three objectives as a first step and as a reminder, number one that's executing on delivering key milestones second is finding the right path forward for <unk> and third is being good stewards of capital as we think about additional <unk>.

Ankit Mahadevia: You know, as we think about additional programs or the like, we've always looked at collaborative partnerships that might build value for shareholders, and once we've made sure that we can execute on our key objectives and that we're looking at what's right for shareholders, we may consider those downstream.

Grams or the like we've always looked at our collaborative partnerships that might yield value for shareholders and once we've made sure that we can execute on our key objectives and we're looking at what's right for shareholders. We may consider those downstream.

And on the final question, So I'll pass it to you any further guidance, we can give on the opex.

Sat Shukla: And on the final question, I'll pass it to you, Chuck, if there's any further guidance we can give on it. Sure. Thanks, Ankit. So, Louise, while we haven't given quarter-by-quarter or annual guidance, which I can direct you to, is our current cash number of $122 million, which obviously was at the end of Q1. Our Q2 bond will be reasonably similar to Q1 because of the restructuring costs that also included severance pay for our impacted colleagues.

Fortunately thanks, Thank you.

Louise while we haven't given quarter by quarter, our annual guidance.

<unk> T is.

Got into cash number of $422 million, which obviously was at the end of Q1.

Our Q2 bond there'll be reasonably similar to Q1 because of the restructuring costs.

I'll say included severance two hour impacted colleagues.

And then you can back out the healthcare royalty partners clients that we referred to in our script.

Sat Shukla: And then you can back out the healthcare royalty partners tranche that we referred to in our script. That will leave you with an estimated cash amount that would be roughly spread out basically between the end of Q2 and the end of 2023, late 2023. So it will be reasonably flat.

That would leave you with a estimated cash amount that would be roughly spread out basically between the end of Q2 and the.

And 2023 late 2023, so it will be reasonably flat.

That ad.

You can suddenly back into our expected opex that'd be anticipated is going for the rest of this year.

Okay. Thank you.

The next question comes from.

Sat Shukla: From that, you can certainly back into our expected OPEX that we anticipate is going on for the rest of this year. Okay, thank you. The next question comes from Raghuram Selvaraju of HC Wainwrights. Thanks very much for taking my questions. I just wanted to get some clarity on whether there's any potential read-through to the tebitenum situation from the way in which the FDA has chosen to handle sulopenum. And if not, why not?

So the <unk> of H C Wainwright.

Raghuram Selvaraju: What are the most notable differences in your view regarding the situation vis-a-vis tebitenum versus sulopenum? Secondly, if you can comment on where you expect the overall market to trend in the context of the tebitenum commercial opportunity, and if we should be thinking about this as a long-term durable opportunity that is unlikely to change meaningfully in the course of the coming months, regardless of how long it may take for tebitenum to ultimately make it to the market in the U.S. And then lastly, if you could maybe just give us some thoughts on what you anticipate the logistical hurdles, if any, to sort of restart commercial preparations from wherever it is you might wind up in the context of what you know right now regarding the FDA's stance on tebitenum. Great, Ram.

Thanks, so much for taking my questions.

One or two.

Get some clarity on whether you think there's any potential read through to the tepid tenant situation from the way in which the FDA has chosen per handle pseudo panel.

And if not why not what are the most notable differences in your view regarding the situation vis vis COVID-19 Panama versus solar panel. Secondly, if you can comment on you know where you expect the overall market.

Could trend in the context of the turbine Pan am commercial opportunity and if we should be thinking about this as a long term durable opportunity that is unlikely to change meaningfully in the course of the coming months, regardless of how long. It may take four type dependent ultimately make it to the market in the U S. And then lastly, if you could maybe just give us some thought.

Box on.

What do you anticipate to be the logistical hurdles if any to.

To sort of restart commercial preparations from wherever it is you might wind up in the context of what you know right now regarding the FDA stance on time. Thanks.

Great. Thank you so much for the questions I'll take the second one first which is that.

Ankit Mahadevia: Thank you so much for the questions. I'll take the second one first, which is that we believe that the long-term prospects for Tevipenem are bright and unchanged. Remember that this is a program with a long patent life to 2038. A large addressable market of patients are in need who are resisting all options. That resistance rate continues to increase year over year.

We believe that the long term.

Prospects for TV panel are bright and I am.

Changed remember that this is a program with a long patent life to 2038, a large addressable market of patients in.

In need who are resisting all options that resistance rate continues to increase year over year and the other thing that we liked about to have economies is that it is a program that doesn't have any branded or late stage development competition. So we think that there's a very long life.

Ankit Mahadevia: And the other thing that we've liked about Tevipenem is that it is a program that doesn't have any branded or late-stage development competition. So we think that there's a very long life here, and that's why we're continuing to clarify the path forward and see that we can move it ahead with the right collaborative partnerships. The second point that I'd make is about your question about any comparison we could make to other agents, specifically Sulipenem.

Life here and why we're continuing to clarify the path forward and see that we can move ahead with the right collaborative partnerships and the second point that I'd make is to your question about any comparison, we could make two other agents specifically solar panel.

Ankit Mahadevia: They're a different indication with a different trial design. Remember that Sulipenem was seeking approval for uncomplicated UTI, whereas Tevipenem is focused on complicated UTI. And the trial designs were different as well, so it's kind of difficult to really make extrapolations there. And to your final point about logistical hurdles, like we've said before, our decision two weeks ago was to cease investing in those types of activities that would bring Tevipenem to patients, assuming a late-June approval in terms of patent life, in terms of drug supply, and in terms of the understanding of the marketplace. If that all still exists.

There are different indication with a different trial design remembered that similar pennant is we're seeking approval for uncomplicated UTI, whereas <unk> is focused on complicated UTI and the trial designs were different as well so it's kind of difficult to to really make extrapolation, there and to your final point.

Logistical hurdles like we've said before our decision two weeks ago was to cease investing in those types of activities that would bring <unk> to patients assuming a late June approval in terms of patent life in terms of drug supply and in terms of the understanding of the marketplace that.

Ankit Mahadevia: And whether that's with a partner or downstream, otherwise, we would see an opportunity to regain that as well as execute on the pipeline. Thank you. The next question comes from Kevin De Gieta of Oppenheimer. Hey guys, thanks for taking questions. Really appreciate it. Maybe just a couple from us all on 720.

I'll still exists and whether that's with a partner or downstream otherwise.

We would see an opportunity to regain that as well as execute on the pipeline.

Thank you.

The next question comes from Kevin <unk>.

Oppenheimer.

Hey, guys. Thanks for taking the questions really appreciate it maybe just a couple from us on 701 eight.

How should we think about potential duration of dosing.

Kevin De Gieta: How should we think about potential duration of dosing, you know, for the planned study? In terms of the study population, is this, you know, all comers, all species, or only MAC patients? I guess I'm a little curious about kind of access to triplet therapy for these patients. I mean, you know, is there sort of a crossover?

For the planned study.

In terms of study population.

This all comers all species are only Mac patients.

I guess I'm, a little curious about kind of access to trip.

Triplet therapy for these patients I mean.

Is there sort of a crossover or are these patients not eligible for kind of current standard of care IV triple therapy any thoughts on those therapy, okay. Great. Thanks, so much.

David Melnick: Are these patients, you know, not eligible for kind of current standard of care, you know, maybe triplet therapy? Any thoughts on those three would be great. Thanks so much. Yeah, thanks a lot, Kevin. So, to your first question, you're right that one of the key considerations we've been engaging the agency on is whether, in light of the three-month toxicology study we've completed, we can dose it longer for the 28 days we were planning.

Yeah, Thanks, a lot Kevin so.

To your first question.

You are right that one of the key considerations, we've been engaging the agency on is whether in light of the three month Tox study was completed we can dose longer for the 28 days, we were planning and we're pleased to say that the agency is open to longer dosing.

David Melnick: And we're pleased to say that the agency is open to longer dosing. You know, as we continue our interactions with the agency and our CROs, we'll say more as we get closer to the clinical start date about the exact protocol. But we can confirm that we have the latitude to dose for longer, and that has a couple of advantages as it relates to the coming clinical readout next year. Number one is that it allows a faster study because longer dosing reduces signal-to-noise and can reduce the number of patients we need to get a signal. Number two is that longer dosing allows for higher fidelity, both at the micro-endpoint, which is critical to show that the drug is active, but also some of the clinical correlates that will be important downstream.

We continue our interactions with the agency and our CFO will say more as we get closer to the clinical start data about the exact protocol, but we can confirm that we have the latitude to dose for longer.

That has a couple of advantages as it relates to the coming clinical readout next year number one is it allows a faster study because longer dosing reduces signal to noise and can reduce the number of patients who need to get a signal number two is longer dosing allows for higher fidelity bulk of the micro endpoint, which is critical to show that the drug is <unk>.

Active but also some of the clinical correlates that'll be important downstream. So we're happy about that and how that translates to the ultimate final protocol will deliver more on that as the as we get closer to the start date.

David Melnick: So, we're happy about that. And how that translates to the ultimate final protocol, we'll deliver more on that as we get closer to the start date. And to your second point, as a reminder, we continue to focus on treatment-emergent MAC or first-line MAC patients. Why? Because, number one, they are patients who still have intact lung function, and we can actually make a clinical benefit for them. Second, it's the largest market space within the NTM arena.

And to your second point as a reminder, we continue to focus on treatment emergent Mac or first slide Mac patients why because number one they are patients who still have intact lung function and we can actually make a clinical benefit for that second it's the largest market space within the MTM arena.

David Melnick: And third, to your point, given that they're early in their disease trajectory, they will be able to, after the trial is complete, have access to triplet standard-of-care generic therapy should they need it. Great, thanks for taking our questions. The next question comes from Esther Holm of Barenburg. Good afternoon. This is Elaine Kim on behalf of Esther.

And third to your point given that they're early in their disease trajectory.

They will be able to after the trial is complete have access to a triplet standard of care generic therapies should they need it.

Great. Thanks for taking our questions.

The next question comes from Esther Hong of Paris.

Eric.

Oh.

Good afternoon. This is Elaine Kim on for <unk>. Thank you for taking our question.

Esther Holm: Thank you for taking our questions. I wanted to ask whether SPR-206 will be tested in CUTI, hospital-acquired and ventilator-associated bacterial pneumonia, and bloodstream infections. Is there a lead indication or indication that you think SPR-206 would benefit most from?

I wanted to ask <unk> will be tested and UTI hospital acquired and ventilator associated bacterial pneumonia and skin infections is there a lead indication an indication that you think SPR true. Thanks.

When most benefit thank you.

Yeah. Thanks, Helane appreciate it and Youre right that SPR two O six has broad applicability wherever resistant pathogens Mame E D.

David Melnick: Thank you. Yeah Thanks, Elaine. I appreciate it. And you're right that SPR-206 has broad applicability wherever resistant pathogens may be. The diseases we're trying to incorporate in that phase two are where the resistant pathogens live. Looking ahead to the pivotal component of the study, we see unmet need across all of those, although pneumonia is a really important one that I might flag just for two reasons. One is that they happen to have a higher prevalence of resistant pathogens where 206 is useful.

The disease and the diseases, we're trying to incorporate in that phase two are where the resistant pathogens live looking ahead to the pivotal component of the study we see unmet need across all of Bell's. Although pneumonia is a really important one that I might flag just for two reasons one is that they happen.

They have a higher prevalence of the resisting pathogens were too low sixes useful second is that a large number of patients with these resistant pathogens tend to be Intubated Covid has shown us that in particular and it's an important patient population for us to learn about.

David Melnick: Second, is that a large number of patients with these resistant pathogens tend to be intubated. COVID has shown us that in particular, and it's an important patient population for us to learn about. Thank you. A quick follow-up question. Do you receive any additional feedback or communications from the FDA since the last update a few weeks ago? And if not, when do you expect to hear from them again?

Thank you a quick follow up question.

Do you receive any additional feedback or communications with the FDA since the last update in a few weeks ago and if not when do you expect to hear from them. Okay. Thank you.

Yeah, Thanks, Helane and I believe you are referring we have ongoing discussions across all of our late stage medicines, but I believe you're referring to can be 10 of them.

Elaine Kim: Thank you. Yeah, thanks, Elaine. And I believe you're referring to, we have ongoing discussions across all of our late stage medicines. I believe you're referring to tebipenem. You know, we continue to have ongoing dialogue during the review cycle for tebipenem.

We continue to have ongoing dialogue during the review cycle or heavy Pan am and as we get more definitive feedback either prior to our Paducah date or after a decision we'll be sure to announce that publicly.

Thank you.

Thank you and that concludes our question and answer session I will now turn the call back over to David.

Ankit Mahadevia: And, you know, as we get more definitive feedback, either prior to our PDUFA date or after a decision, we'll be sure to announce that publicly. Thank you. Thank you. And that concludes our question and answer session. I will now turn the call back over to Dr. Mahadeva. Thank you, Operator, and thanks to everyone who listened to today's update. We look forward to moving ahead with our new key objectives.

Please go ahead.

Thank you operator, and thanks to everyone, who listen to today's update we look forward to moving ahead with our new key objectives wish you all a nice evening.

Ankit Mahadevia: Wish you all a nice evening. Thank you. Ladies and gentlemen, thank you for your participation. You may now disconnect your line. Music Music Music Music Music Music Music Music Music Music, © BF-WATCH TV 2021, Ritu Baral, Esther Rajavelu, Unknown Executive, Unknown Attendee, Boobalan Pachaiyappan, Gavin Clark, Raghuram Selvaraju, Kamal Hamed, Satyavrat Shukla, Ted Jenkins, Spero Therapeutics Inc Ritu Baral, Esther Rajavelu, Unknown Executive, Unknown Attendee, Boobalan Pachaiyappan, Gavin Clark, Raghuram Selvaraju, Kamal Hamed, Satyavrat Shukla, Ted Jenkins, Spero Therapeutics Inc Ritu Baral, Esther Rajavelu, Unknown Executive, Unknown Attendee, Boobalan Pachaiyappan, Gavin Clark, Raghuram Selvaraju, Kamal Hamed, Satyavrat Shukla, Ted Jenkins, Spero Therapeutics Inc .

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Thank you ladies and gentlemen, thank you for your participation you may now disconnect your lines.

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