Q4 2024 Spero Therapeutics Inc Earnings Call
Speaker Change: Prof. S. P. Rajavelu, Satyavrat Shukla, Unknown Executive S. P. Rajavelu, Satyavrat Shukla, Unknown Executive Prof. S. P. Rajavelu, Satyavrat Shukla, Unknown Executive
Raghuram Selvaraju, Spero Therapeutics Inc.
Speaker Change: Good afternoon and welcome to the Spero Therapeutics, Fourth Quarter and Folier 2024 Arning Conference Call. At this time, all participants are in listen only mode. Following the company's formal remarks, we will open up the call for questions.
Speaker Change: Please be advised that this call is being recorded and a replay will be available. You can find information on the replay and further information related to today's announcement. On the
Speaker Change: At this time, I would like to turn the call over to Shah Bearing, Senior Director Investor Mr. Bearing, please go ahead.
Speaker Change: Thank you, Operator, and thank you all for participating in today's conference call. This afternoon, Spero Therapeutics released financial results and provided a business update
Speaker Change: The press release is available on the investor page of the Spero Therapeutics website.
Speaker Change: Before we begin, I would like to remind you that some of the information presented on this conference call contains forward-looking statements under the security's laws.
Speaker Change: It could cause our actual clinical programs future results progress timing performances or achievements to differ materially from those expressed or implied by such forward looking statements.
Yeah.
Speaker Change: These risks and uncertainties associated with our business and factors that could cause or contribute to such differences are described in detail in the spirit therapeutics filings with the SEC, including in the risk factors section of the earnings report on Form 10-K for the year ended December 31 2024.
Speaker Change: Filled with the SEC today.
Ed: Joining me on the call today are Ed <unk>, our interim Chief Executive Officer, and Chief Financial Officer.
Ed: And Tim Kreitzer, Spirit's Chief operating officer.
Ed: There will be a Q&A session following the prepared remarks.
Ed: I will now turn the call over to enter to the game.
Ed: Thank you Shai good afternoon, everyone and thank you for joining our full year 2024 earnings and business update call.
Speaker Change: Theyre Therapeutics is a clinical stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases, and multi drug resistant bacterial infections with high unmet medical need.
Speaker Change: Our most advanced clinical stage product candidate habitat them HDR is in a phase III trial with the potential to be the first broad spectrum oral carpet that them to treat adult patients with complicated urinary tract infections, including acute pyelonephritis.
Speaker Change: These are patients who have limited or no alternative treatment options and would otherwise likely be treated with an IV cobre Panama.
Speaker Change: Spiro, it's co developing Toby tenant HDR with our partner GSK.
Speaker Change: Today, we announced that a pre specified interim analysis in the phase III pivotal clinical trial is expected to be completed in the second quarter 2025.
Speaker Change: Our top priority for this year the continued advancement of the Epipen program.
Speaker Change: If approved has the potential to fundamentally change the treatment paradigm for complicated UTI by offering patients and prescribers a convenient oral treatment option.
Speaker Change: Next onto S. P. R 720.
Speaker Change: Our novel <unk> inhibitor that was in a phase two proof of concept study as an oral treatment for non tuberculosis mycobacteria or pulmonary disease.
Speaker Change: T M T.
Speaker Change: The trial was randomized double blind placebo controlled and Ngos 25 treatment naive.
Speaker Change: Or treatment experienced patients with non refractory N T M pulmonary disease.
Speaker Change: <unk> by Mycobacterium Avium complex or Mac infections.
Speaker Change: The primary endpoint of the study was change in bacterial load in sputum samples from baseline to the end.
Speaker Change: Six day treatment period.
Speaker Change: Key secondary endpoints included assessments of safety and Tolerability clinical response, PK and certain other measures.
Goldman: Goldman concluded in July 2024.
Goldman: In October 2024, we completed a planned interim analysis, which included 16 patients who had completed dosing and post dose follow up visits.
Goldman: Results from the interim analysis showed that the study did not meet its primary endpoint.
Goldman: While there was some evidence of anti microbial activity the treated arm did not show sufficient separation from placebo and.
Goldman: In addition, we saw potential dose limiting safety signals, including three cases of reversible grade three hepatic toxicity in the high dose cohort dose that a 1000 milligrams once daily.
Goldman: We are completing assessment full data set of all 25 patients dosed in the trial and plan to determine next steps for the program once that is complete.
Goldman: Lastly on our pipeline following a thorough review and re prioritization, we made the decision to discontinue development of SPR <unk> six and.
Goldman: An IV administered Nextgen polymyxin antibiotic.
Goldman: Cleared in R&D in 2024 square a phase two trial in hospital acquired and ventilator associated bacterial pneumonia.
To date, we have made good progress on the phase III trial for our lead asset <unk> H B R and we look forward to completing the Prespecified interim analysis next quarter.
Goldman: And with our partner GSK share an update on next steps for the program.
Goldman: As a reminder.
Goldman: Following completion of the turbine Panama H B, our phase III trial, GSK is expected to assume responsibility for regulatory and commercialization efforts.
Goldman: And these are successfully pursued spiro could qualify for about $400 million in contingent milestones, including $25 million when GSK submits an M D E and subsequent milestones based on commercialization and sales ramp.
Tim Kreitzer: With that I'll turn the call over to Tim.
Tim Kreitzer: Thank you Sir.
Tim Kreitzer: I'll begin with <unk> and the opportunity for this product to address the unmet need in complicated UTI.
Tim Kreitzer: There are an estimated $3 4 million episodes of complicated UTI is reported annually in the U S and they are a leading cause of hospitalizations.
Tim Kreitzer: Complicated infections as a reminder are those that occur in patients who have a structural or functional abnormality of urinary tract for those requiring capitalization.
Tim Kreitzer: There can also be comorbidities, such as kidney stones or kidney infections.
Speaker Change: You guys are also more likely to be caused by multi drug resistant or MTR pathogens.
Speaker Change: Inadequately treated these can recur frequently where progressive more severe conditions.
Speaker Change: The current standard of care for many MBR gram negative infections, including complicated utis as treatment with carbon patents.
However, carbon atoms are currently only available as intravenous formulations. So they require inpatient admission outpatient IV therapy and this adds to the complexity of treatment.
Speaker Change: The lack of an effective well tolerated oral alternatives for MTR complicated utis means that patients are often subjected to prolonged IV antibiotic use.
Speaker Change: If approved we believe have you been with HCR has the potential to reduce length of hospitalization for patients who transition from intravenous to oral carboplatin therapy.
Speaker Change: The ongoing phase III trial pivot P. O designed to support regulatory approval is a global randomized double blind double dummy clinical trial, comparing <unk> to IV <unk> in hospitalized adult patients with complicated utis, including acute pyelonephritis.
Speaker Change: Patients are being randomized one to one to receive either turbine them at a dose of 600 milligrams orally every six hours or IV and within them. So statin given US 500 milligrams every six hours for a total of seven to 10 days.
Speaker Change: The primary efficacy endpoint is overall response, which is a composite of clinical cure and microbiological eradication. This is assessed at the test of cure visit.
Speaker Change: The primary analysis will assess noninterest already in the microbiological intent to treat population using a 10% margin.
Speaker Change: Refund Euro seven 'twenty, our decision to spin the oral development program in MTM pulmonary disease, followed a preplanned interim analysis based on 16 patients in the phase Iia proof of concept trial.
Speaker Change: We're now in the process and completing analysis of the remaining data from all 25 patients who were dosed in the trial and plan to determine next steps for this program thereafter.
Speaker Change: I'll now turn the call back to <unk> to review the financials.
Speaker Change: Thank you Tim I'll now walk you through our fourth quarter and full year financials.
Speaker Change: As of December 31, 2020 for Spero had cash and cash equivalents of $52 9 million.
Speaker Change: We estimate that our existing cash and cash equivalents together with the remaining $47 5 million in earned and non contingent development milestone from GSK will be sufficient to fund our operating expenses and capital expenditures into Q2 2026.
Speaker Change: Total revenue for the fourth quarter of 2024 was 15 million compared with total revenue of $73 5 million for the fourth quarter of 2023.
Speaker Change: Total revenue for the year ended December 31, 2024 was 48 million compared to $103 8 million for the year ended December 31 2023.
Speaker Change: The revenue decrease compared with the prior year period was primarily due to a decrease in collaboration revenue from our agreements with GSK and Pfizer.
Speaker Change: R&D expenses for the fourth quarter of 2024 were $28 8 million compared to $16 6 million for the same period in 2023.
Speaker Change: R&D expenses for the year ended December 31, 2024 were 97 million compared to 51 4 million for the year ended December 31 2023.
Speaker Change: The increase in R&D expenses year over year was primarily due to increased clinical trial activities related to the phase III pivotal trials with Cabo <unk> HDR.
Speaker Change: G&A expenses for the fourth quarter of 2024 were $7 1 million compared to $6 4 million for the same period in 2023.
Speaker Change: This year over year increase was primarily due to increased consulting and professional fees in the last quarter of the year.
Speaker Change: G&A expenses for the year ended December 31, 2024 by $23 7 million compared to $25 6 million for the year ended December 31 2023.
Speaker Change: With lower full year 'twenty for expenses, primarily due to decreases in personnel related cost.
Speaker Change: The company reported a net loss of $20 7 million for the fourth quarter and net loss of $68 4 million for the year ended December 31 2024.
Speaker Change: Diluted net loss per share.
Speaker Change: With 38 cents.
Speaker Change: And $1 27 for these periods respectively.
Speaker Change: We reported a net income of 51.2 million for the fourth quarter of 2023, and net income of $22 8 million for the year ended December 31 2023, respectively.
Speaker Change: Net income per share was <unk> 96, and 43, where these periods respectively.
Speaker Change: For further details on our financials. Please refer to our 10-K filed with the SEC today.
Speaker Change: With that we will now open the call for questions operator.
Speaker Change: Thank you.
Speaker Change: I'll begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.
Speaker Change: Youre using a speakerphone please pick up your handset before pressing the keys.
Speaker Change: Anytime you have a question has been addressed and we would like to withdraw your question. Please press Star then two.
Speaker Change: Yeah.
Operator: First question comes from Kevin Clark Gardner with Evercore ISI. Please go ahead.
Yeah.
Speaker Change: Hey, Thanks for taking the questions I had a few on the turbine pan of interim analysis.
Speaker Change: Maybe first does the trial get unblinded, if the interim is successful.
Speaker Change: If the interim is successful yes, the interim process, it's going to be managed by an independent data monitoring committee and if their recommendation is that we stopped the trial.
Speaker Change: A stopping rule that the management team will be unblinded at that time.
Speaker Change: Got it.
Speaker Change: So if it does get unblinded early I guess, what I'm wondering is.
Speaker Change: Even if the trial's positive early on on the ITT population is there any reason to keep running the trial longer in order to narrow some of the error bars for some of the subgroup analyses like specifically in the E. S. P. L positive population.
Speaker Change: Yeah, we can't speculate on that at the moment, given we're blinded and just preparing for the interim analysis so well.
Speaker Change: Hopefully be able to respond to that.
Speaker Change: <unk> gotten the recommendation from the IBM Z.
Speaker Change: Got it.
Speaker Change: Whats the alpha spend on the interim.
Speaker Change: We'll be spending a small amount of alpha for the pre specified I think since this is a pre specified interim we've accounted for that alpha spend in determining the overall sample size for the study.
Speaker Change: Got it.
Speaker Change: Last quick question any comments you can make on the bar for success for the interim and when in the trial, it's actually conducted.
Speaker Change: So basically I mean, there are three scenarios that are likely right. So either the trial meets the primary endpoint with a pre specified interim which is the 10% non inferiority margin.
Speaker Change:
Speaker Change: And when you stop the trial or you know it fails why we stopped the trial for futility or lastly, we continue enrolling.
Speaker Change: Got it that's.
Speaker Change: That's helpful. Thanks.
Speaker Change: Once again, if you have a question. Please press Star then one.
Bra: Our next question comes from repo Bra with TD Cowen. Please go ahead.
Speaker Change: Hi, guys. Thanks for taking my question. This is Athena Chen on for <unk> I have a question on <unk> 'twenty as you see it now what are the potential paths forward for 720 N and when can we expect an update thank you.
Speaker Change: Sure Hey, there.
Speaker Change: First step is to complete the data analysis of the full 25 patients dosed in the trial. Once we have the full picture on the data will be in a better position to decide on the best path forward for the program, which may include a reformulation strategy.
Speaker Change:
Speaker Change: We have determined that an oral path for N. P. M. P. D is unlikely given the dose limiting grade III talks at the thousand Mac dose, even though they were reversible wants to drop in the stock. So step number one complete the data analysis on the full 25 patients and then determine next steps.
Speaker Change: Understood. Thank you.
Speaker Change: This concludes our question and answer session I would like to turn the conference back over to management for any closing remarks. Please go ahead.
Speaker Change: Thank you.
Speaker Change: We have a very excited set up for the yearend.
Speaker Change: And we're looking forward to completing the interim analysis and providing you an update in the second quarter. Thank you for listening.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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