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Spero Therapeutics Announces Second Quarter 2024 Operating Results and Provides a Business Update

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Spero Therapeutics (NASDAQ: SPRO) announced Q2 2024 results and provided a business update. Key highlights include:

  • Enrollment concluded in Phase 2a trial of SPR720 for NTM-PD; preliminary data expected in Q4 2024
  • New SPR720 in-vitro resistance data to be presented at IDWeek 2024
  • CMO Kamal Hamed departing; John C. Pottage, Jr., M.D. appointed as Special Advisor
  • Cash balance of $63.5 million as of June 30, 2024; runway into late 2025
  • Q2 2024 net loss of $17.9 million, or ($0.33) per share
  • Total revenue increased to $10.2 million in Q2 2024 from $2.7 million in Q2 2023
  • R&D expenses increased to $23.7 million in Q2 2024 from $9.5 million in Q2 2023

Spero Therapeutics (NASDAQ: SPRO) ha annunciato i risultati del secondo trimestre del 2024 e fornito un aggiornamento aziendale. I punti salienti includono:

  • Completamento dell'arruolamento nella fase 2a della sperimentazione di SPR720 per NTM-PD; dati preliminari attesi per il quarto trimestre del 2024
  • Nuovi dati di resistenza in-vitro di SPR720 saranno presentati a IDWeek 2024
  • Il CMO Kamal Hamed lascia l'azienda; John C. Pottage, Jr., M.D. è stato nominato Consigliere Speciale
  • Il saldo di cassa è di 63,5 milioni di dollari al 30 giugno 2024; fondi disponibili fino a fine 2025
  • Perdita netta del secondo trimestre del 2024 di 17,9 milioni di dollari, pari a ($0,33) per azione
  • Il fatturato totale è aumentato a 10,2 milioni di dollari nel secondo trimestre del 2024, rispetto ai 2,7 milioni di dollari nel secondo trimestre del 2023
  • Le spese per R&S sono aumentate a 23,7 milioni di dollari nel secondo trimestre del 2024, rispetto ai 9,5 milioni di dollari nel secondo trimestre del 2023

Spero Therapeutics (NASDAQ: SPRO) anunció los resultados del segundo trimestre de 2024 y proporcionó una actualización comercial. Los puntos destacados incluyen:

  • Se concluyó la inscripción en el ensayo de fase 2a de SPR720 para NTM-PD; se esperan datos preliminares para el cuarto trimestre de 2024
  • Nuevos datos de resistencia in-vitro de SPR720 se presentarán en IDWeek 2024
  • El CMO Kamal Hamed se va de la empresa; John C. Pottage, Jr., M.D. fue nombrado Asesor Especial
  • El saldo de efectivo es de 63,5 millones de dólares al 30 de junio de 2024; reservas hasta finales de 2025
  • Pérdida neta del segundo trimestre de 2024 de 17,9 millones de dólares, o ($0,33) por acción
  • Los ingresos totales aumentaron a 10,2 millones de dólares en el segundo trimestre de 2024, desde 2,7 millones de dólares en el segundo trimestre de 2023
  • Los gastos de I+D aumentaron a 23,7 millones de dólares en el segundo trimestre de 2024, desde 9,5 millones de dólares en el segundo trimestre de 2023

Spero Therapeutics (NASDAQ: SPRO)는 2024년 2분기 결과를 발표하고 비즈니스 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:

  • NTM-PD에 대한 SPR720 2a 단계 시험에서 등록이 완료되었습니다; 2024년 4분기에 예비 데이터가 예상됩니다
  • IDWeek 2024에서 SPR720의 새로운 인-비트로 저항 데이터가 발표될 예정입니다
  • CMO Kamal Hamed가 퇴사하고 John C. Pottage, Jr., M.D.가 특별 고문으로 임명되었습니다
  • 2024년 6월 30일 기준 현금 잔고는 6,350만 달러이며, 2025년 말까지 운영 자금이 확보되어 있습니다
  • 2024년 2분기 순손실은 1,790만 달러, 주당 ($0.33)입니다
  • 2024년 2분기 총 수익은 1,020만 달러로, 2023년 2분기 270만 달러에서 증가했습니다
  • 2024년 2분기 R&D 비용은 2,370만 달러로, 2023년 2분기 950만 달러에서 증가했습니다

Spero Therapeutics (NASDAQ: SPRO) a annoncé les résultats du deuxième trimestre 2024 et fourni une mise à jour commerciale. Les faits saillants incluent :

  • Inscription terminée dans l'essai de phase 2a de SPR720 pour NTM-PD ; des données préliminaires sont attendues au quatrième trimestre 2024
  • De nouvelles données de résistance in-vitro pour SPR720 seront présentées à IDWeek 2024
  • Le CMO Kamal Hamed quitte l'entreprise ; John C. Pottage, Jr., M.D. a été nommé Conseiller Spécial
  • Le solde de trésorerie est de 63,5 millions de dollars au 30 juin 2024 ; financement disponible jusqu'à fin 2025
  • Perte nette de 17,9 millions de dollars pour le deuxième trimestre 2024, soit ($0,33) par action
  • Le chiffre d'affaires total a augmenté à 10,2 millions de dollars au deuxième trimestre 2024, contre 2,7 millions de dollars au deuxième trimestre 2023
  • Les dépenses de R&D ont augmenté à 23,7 millions de dollars au deuxième trimestre 2024, contre 9,5 millions de dollars au deuxième trimestre 2023

Spero Therapeutics (NASDAQ: SPRO) hat die Ergebnisse des zweiten Quartals 2024 bekannt gegeben und ein Unternehmensupdate bereitgestellt. Die wichtigsten Punkte umfassen:

  • Die Rekrutierung in der Phase-2a-Studie von SPR720 für NTM-PD wurde abgeschlossen; erste Daten werden für das vierte Quartal 2024 erwartet
  • Neue In-vitro-Widerstandsdaten zu SPR720 werden auf der IDWeek 2024 vorgestellt
  • Der CMO Kamal Hamed verlässt das Unternehmen; John C. Pottage, Jr., M.D. wurde zum besonderen Berater ernannt
  • Zum 30. Juni 2024 beträgt der Barguthaben 63,5 Millionen US-Dollar; Geldmittel bis Ende 2025
  • Die Nettoperformance im 2. Quartal 2024 betrug 17,9 Millionen US-Dollar oder ($0,33) pro Aktie
  • Der Gesamtumsatz stieg im 2. Quartal 2024 auf 10,2 Millionen US-Dollar, gegenüber 2,7 Millionen US-Dollar im 2. Quartal 2023
  • Die F&E-Ausgaben stiegen im 2. Quartal 2024 auf 23,7 Millionen US-Dollar, gegenüber 9,5 Millionen US-Dollar im 2. Quartal 2023
Positive
  • Enrollment concluded in Phase 2a trial of SPR720 for NTM-PD with data expected in Q4 2024
  • Cash runway extended into late 2025
  • Total revenue increased to $10.2 million in Q2 2024 from $2.7 million in Q2 2023
  • Enrollment on track for PIVOT-PO global Phase 3 trial of tebipenem HBr
Negative
  • Net loss increased to $17.9 million in Q2 2024 from $11.9 million in Q2 2023
  • R&D expenses increased to $23.7 million in Q2 2024 from $9.5 million in Q2 2023
  • Departure of Chief Medical Officer Kamal Hamed

Insights

Spero Therapeutics' Q2 2024 results reveal a mixed financial picture. The company reported a $17.9 million net loss ($0.33 per share), wider than the $11.9 million loss in Q2 2023. However, revenue increased significantly to $10.2 million from $2.7 million year-over-year, primarily due to collaboration revenue from GSK for tebipenem HBr.

R&D expenses rose to $23.7 million from $9.5 million, reflecting increased investment in clinical trials. The cash position of $63.5 million as of June 30, 2024, is projected to fund operations into late 2025, providing a reasonable runway for ongoing clinical programs. The increased revenue and strategic partnerships are positive, but the widening losses and higher R&D expenses indicate a capital-intensive phase that investors should monitor closely.

Spero's pipeline progress is noteworthy, particularly for SPR720 and tebipenem HBr. The completion of enrollment in the Phase 2a trial for SPR720 in NTM-PD, with 25 patients, is a significant milestone. The upcoming preliminary data in Q4 2024 on SPR720's early bactericidal activity will be important in assessing its potential as a first-line oral treatment for NTM-PD.

The ongoing PIVOT-PO Phase 3 trial for tebipenem HBr in cUTI is progressing as planned, with a substantial target enrollment of 2,648 patients. If successful, tebipenem HBr could become the first oral carbapenem for cUTI and AP, potentially reducing hospitalizations. The completion of two Phase 1 studies for SPR720 and the upcoming presentation at IDWeek 2024 further demonstrate the company's commitment to advancing its pipeline. These developments position Spero well in the rare diseases and MDR bacterial infections space.

  • Enrollment concluded in the Phase 2a proof-of-concept clinical trial evaluating SPR720 in nontuberculous mycobacterial pulmonary disease (NTM-PD); preliminary data expected in 4Q 2024
  • New SPR720 in-vitro resistance data to be presented at IDWeek 2024 conference in October
  • Company announces departure of Chief Medical Officer Kamal Hamed, MD, MPH, MBA; Appoints Board member and Chair of Development Committee John C. Pottage, Jr., M.D., as Special Advisor to oversee medical function; search ongoing for a new CMO
  • Cash balance of $63.5 million as of June 30, 2024; reiterate expected cash runway into late 2025
  • Conference call and webcast at 4:30pm ET today

CAMBRIDGE, Mass., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced financial results for the second quarter ended June 30, 2024, and provided a business update.

“Spero’s pipeline of both wholly-owned and partnered clinical-stage programs continues to advance as planned this year,” said Sath Shukla, President and Chief Executive Officer of Spero. “We recently concluded enrollment in the Phase 2a trial of SPR720 in treatment-naive and treatment-experienced non-refractory NTM-PD patients, and we anticipate reporting data in the fourth quarter of 2024. In addition, we remain on track with enrollment in the ongoing global Phase 3 PIVOT-PO clinical trial with tebipenem HBr. We are hopeful that both SPR720, with the potential to be the first approved oral agent in NTM-PD, and Tebipenem, with the potential to be the first oral carbapenem for complicated urinary tract infection (cUTI) and acute pyelonephritis (AP), could become meaningfully differentiated treatment options for patients and expand treatment choice for providers.”

Pipeline Update

SPR720

SPR720 is an investigational novel, oral, first-line treatment for NTM-PD.

  • Enrollment has concluded, with 25 patients enrolled in the Phase 2a proof-of-concept clinical trial evaluating SPR720 in NTM-PD. The last patient received the first dose in July 2024. Preliminary data on SPR720’s early bactericidal activity, as assessed by the change in NTM bacterial load over the treatment course of 56 days, are expected in 4Q 2024. The rate of change in log10 Colony Forming Units per milliliter (CFU/mL), which is the trial’s primary endpoint, is being measured, along with the rate of change in Time to Positivity, which is a key secondary endpoint. The double-blinded, placebo-controlled, trial enrolled treatment-naïve and treatment-experienced patients with non-refractory NTM-PD due to Mycobacterium avium complex in 3 treatment groups (placebo, SPR720 500 mg and SPR720 1000 mg dosed QD). Additional secondary endpoints include assessments of pharmacokinetics and safety and tolerability. For more information on the trial, see ClinicalTrials.gov identifier NCT05496374.
  • Dosing completed in two Phase 1 clinical studies evaluating SPR720 in healthy volunteers: 1) a bronchoalveolar lavage (BAL) study assessing intrapulmonary PK (epithelial lung fluid and alveolar macrophage) of SPR719, the active moiety of the prodrug SPR720 (NCT05955586), and 2) a study evaluating changes in plasma PK when SPR720 is co-administered with azithromycin and ethambutol (NCT05966688). Topline results from both studies are also expected to be disclosed in 4Q of 2024.

Upcoming Presentation

  • Data from in vitro evaluation of the development of microbial resistance against SPR720 have been accepted for presentation at IDWeek, taking place October 16 to 19, 2024 in Los Angeles, CA.

Tebipenem HBr

Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of cUTI including acute pyelonephritis (AP) to help patients avoid hospitalizations or reduce duration of in-patient therapy. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories.

  • Enrollment on track in PIVOT-PO, the global Phase 3 clinical trial of tebipenem HBr in patients with cUTI. This randomized, double-blinded trial compares oral tebipenem HBr with intravenous imipenem cilastatin, in hospitalized adult patients with cUTI/AP. The primary endpoint is overall response (a combination of clinical cure and favorable microbiological response) at the Test-of-Cure (TOC) visit. Target enrollment for the trial is approximately 2,648 patients, with enrollment completion expected in the second half of 2025. For more information on PIVOT-PO, refer to ClinicalTrials.gov ID NCT06059846.

SPR206

SPR206 is an investigational, intravenously administered next-generation polymyxin that has shown antibiotic activity against MDR Gram-negative pathogens, including carbapenem-resistant Enterobacterales, Acinetobacter baumannii and Pseudomonas aeruginosa in preclinical studies.

  • The U.S. Food and Drug Administration (FDA) cleared the Company's IND for a Phase 2 trial in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). The Company maintains its guidance to initiate the trial, contingent on availability of non-dilutive funding.

Corporate Update

  • Kamal Hamed, MD, MPH, MBA, Chief Medical Officer, is departing the Company, effective August 29, 2024.
  • John C. Pottage, Jr., M.D., a member of Spero’s Board of Directors since August 2018, with over 20 years of experience advancing therapeutics for infectious diseases, has been appointed Special Advisor to oversee the Company’s medical function, effective immediately, and will assume responsibility for oversight of Spero’s pipeline programs, including the ongoing clinical studies for SPR720 and Tebipenem HBr. Dr. Pottage has served as Senior Vice President and Chief Scientific and Medical Officer of ViiV Healthcare, where he oversaw research and development, regulatory, safety and medical affairs. Prior to that, Dr. Pottage served as Senior Vice President and Head of the Infectious Disease Medicine Development Center at GSK (formerly GlaxoSmithKline), and prior to that, as Vice President of Global Clinical Development of Antivirals at GSK. Earlier in his career he held senior clinical development roles at Achillion Pharmaceuticals and Vertex Pharmaceuticals, as well as various academic/ clinical positions at Rush University Medical Center. In connection with this appointment, Dr. Pottage has stepped aside from the Company’s audit committee, as he will not meet the independence requirements for service on the audit committee while serving as a Special Advisor to the Company.

Mr. Shukla added, “We wish to thank Kamal for his significant contribution to the development and advancement of Spero’s three clinical programs over the last two years. At the same time, we are pleased that our clinical programs will be under the extremely capable oversight of Dr. Pottage while we continue our ongoing search for a new Chief Medical Officer.”

Second quarter 2024 Financial Results

  • Spero reported a net loss of $17.9 million, or ($0.33) per share of common stock, basic and diluted, for the second quarter ended June 30, 2024, compared with a net loss of $11.9 million, or ($0.23) per share of common stock, basic and diluted, for the second quarter ending June 30, 2023.
  • Total revenue for the second quarter of 2024 was $10.2 million, compared with total revenue of $2.7 million for the second quarter of 2023. The revenue increase for the second quarter of 2024 was primarily due to an increase in collaboration revenue related to our agreement with GSK for tebipenem HBr and an increase in grant revenue related to our BARDA contract for tebipenem HBr, partially offset by a decrease under our NIAID agreement relating to SPR206 and collaboration revenue related to our agreement with Pfizer for SPR206.
  • Research and development expenses for the second quarter of 2024 were $23.7 million, compared to $9.5 million of research and development expenses for the same period in 2023. The increase in research and development expenses year-over-year was primarily due to higher direct costs related to the pivotal Phase 3 trial for tebipenem HBr and the Phase 2a clinical trial for SPR720, partially offset by lower direct expenses related to SPR206 and lower R&D personnel-related costs.
  • General and administrative (G&A) expenses for the second quarter of 2024 were $5.5 million, compared to $6.1 million of general and administrative expenses for the same period in 2023. This year-over-year decrease was primarily due to a decrease in G&A personnel-related costs, partially offset by increases in professional and consulting fees and facility-related expenses.
  • As of June 30, 2024, Spero had cash and cash equivalents of $63.5 million. Based on its current operating plans, Spero expects that its cash and cash equivalents, together with other non-dilutive funding commitments, will be sufficient to fund its operating expenses and capital expenditure requirements into late 2025.

For further details on Spero’s financials, refer to Spero’s Quarterly Report on Form 10-Q, filed with the U.S. Securities and Exchange Commission (SEC) today.

Conference Call and Live Webcast
Spero will host a conference call and live audio webcast today at 4:30 p.m. to report its second quarter 2024 financial results and provide an update on its business and pipeline. To access the call, please dial 1-877-269-7751 (domestic) or 1-201-389-0908 (international) and refer to conference ID 13747505, or click on this link and request a return call. The audio webcast can be accessed live on this link and also on the “Investor Relations” page of the Spero Corporate Website at https://sperotherapeutics.com. The archived webcast will also be available on Spero’s website for 30 days following the call.

About Spero Therapeutics
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a multi-asset clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need. For more information, visit www.sperotherapeutics.com

Government Agency Research Support
The views expressed in this press release are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.

Tebipenem HBr Research Support
Select tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C.

Department of Defense
Select SPR206 studies have been supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Joint Warfighter Medical Research Program under Award No. W81XWH 19 1 0295. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

National Institute of Allergy and Infectious Disease
Select SPR206 studies have been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93021C00022.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing, progress and results of Spero's preclinical studies, clinical trials and research and development programs; the potential benefits of any of Spero’s current or future product candidates in treating patients; and Spero’s strategy, goals and anticipated financial performance, milestones, business plans and focus. In some cases, forward-looking statements may be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms or other similar expressions. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual results to differ materially from those indicated by such forward looking statements, including whether tebipenem HBr, SPR720 and SPR206 will advance through the clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero's reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; Spero's need for additional funding; the ability to commercialize Spero's product candidates, if approved; Spero's ability to retain key personnel; Spero's leadership transitions; whether Spero's cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the "Risk Factors" set forth in filings that Spero periodically makes with the SEC. The forward-looking statements included in this press release represent Spero's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Spero explicitly disclaims any obligation to update any forward-looking statements.

Investor Relations Contact:
Shai Biran, PhD
Spero Therapeutics
IR@Sperotherapeutics.com

Media Inquiries:
media@sperotherapeutics.com

 
Spero Therapeutics, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
(Unaudited)
     
  June 30, December 31,
   2024  2023
Cash, cash equivalents and marketable securities $63,527  $76,333
Other assets  86,354  106,057
Total assets $ 149,881   $ 182,390
     
Total liabilities  69,381   75,496
Total stockholder's equity  80,500  106,894
Total liabilities and stockholders' equity $ 149,881  $ 182,390
     


Spero Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
         
  Three Months Ended June 30, Six Months Ended June 30,
   2024   2023   2024   2023 
Revenues:        
Grant revenue $4,180  $1,928  $9,243  $3,258 
Collaboration revenue - related party  5,903   519   9,967   1,036 
Collaboration revenue  114   269   254   492 
Total revenues  10,197   2,716   19,464   4,786 
Operating expenses:        
Research and development  23,725   9,510   41,057   18,489 
General and administrative  5,533   6,096   11,450   13,413 
Total operating expenses  29,258   15,606   52,507   31,902 
Loss from operations  (19,061)  (12,890)  (33,043)  (27,116)
Other income (expense)  1,199   976   2,512   1,936 
Net loss $(17,862) $(11,914) $(30,531) $(25,180)
Net loss per share attributable to common shareholders per share, basic and diluted $(0.33) $(0.23) $(0.57) $(0.48)
         
Weighted average shares outstanding, basic and diluted:  53,957,766   52,571,813   53,740,901   52,549,538 

FAQ

What were Spero Therapeutics' (SPRO) Q2 2024 financial results?

Spero Therapeutics reported a net loss of $17.9 million, or ($0.33) per share, for Q2 2024. Total revenue was $10.2 million, and the company had a cash balance of $63.5 million as of June 30, 2024.

When does Spero Therapeutics (SPRO) expect preliminary data from the SPR720 Phase 2a trial?

Spero Therapeutics expects to report preliminary data from the Phase 2a trial of SPR720 in nontuberculous mycobacterial pulmonary disease (NTM-PD) in the fourth quarter of 2024.

What is the status of Spero Therapeutics' (SPRO) tebipenem HBr Phase 3 trial?

Enrollment is on track in the PIVOT-PO global Phase 3 clinical trial of tebipenem HBr for complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). Enrollment completion is expected in the second half of 2025.

How long does Spero Therapeutics (SPRO) expect its current cash to last?

Based on current operating plans, Spero Therapeutics expects its cash and cash equivalents, along with other non-dilutive funding commitments, to be sufficient to fund operations into late 2025.

Spero Therapeutics, Inc.

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