Spero Therapeutics Announces Third Quarter 2024 Operating Results and Provides a Business Update
Spero Therapeutics (SPRO) reported Q3 2024 financial results with a net loss of $17.1 million ($0.32 per share), compared to $3.2 million loss in Q3 2023. Revenue decreased to $13.5 million from $25.5 million year-over-year. The company's Phase 3 PIVOT-PO trial for tebipenem HBr remains on track for enrollment completion in 2H 2025. Following SPR720 development suspension and a 39% workforce reduction, cash position stands at $76.3 million, extending runway into mid-2026. R&D expenses increased to $26.9 million from $16.4 million, while G&A expenses decreased to $5.2 million from $5.7 million year-over-year.
Spero Therapeutics (SPRO) ha riportato i risultati finanziari del terzo trimestre 2024 con una perdita netta di $17,1 milioni ($0,32 per azione), rispetto a una perdita di $3,2 milioni nel terzo trimestre 2023. I ricavi sono diminuiti a $13,5 milioni rispetto ai $25,5 milioni dell'anno precedente. Lo studio clinico di Fase 3 PIVOT-PO per il tebipenem HBr è ancora in linea per completare l'arruolamento nella seconda metà del 2025. A seguito della sospensione dello sviluppo di SPR720 e di una riduzione della forza lavoro del 39%, la posizione di liquidità si attesta a $76,3 milioni, estendendo la disponibilità fino a metà 2026. Le spese per R&S sono aumentate a $26,9 milioni rispetto ai $16,4 milioni, mentre le spese generali e amministrative sono diminuite a $5,2 milioni dai $5,7 milioni dell'anno precedente.
Spero Therapeutics (SPRO) reportó los resultados financieros del tercer trimestre de 2024 con una pérdida neta de $17,1 millones ($0,32 por acción), en comparación con una pérdida de $3,2 millones en el tercer trimestre de 2023. Los ingresos disminuyeron a $13,5 millones desde $25,5 millones en el año anterior. El ensayo clínico de Fase 3 PIVOT-PO para tebipenem HBr sigue en marcha y se espera que complete la inscripción en la segunda mitad de 2025. Tras la suspensión del desarrollo de SPR720 y una reducción del 39% en la fuerza laboral, la posición de efectivo se sitúa en $76,3 millones, prolongando la disponibilidad hasta mediados de 2026. Los gastos de I+D aumentaron a $26,9 millones desde $16,4 millones, mientras que los gastos generales y administrativos disminuyeron a $5,2 millones desde $5,7 millones en el año anterior.
Spero Therapeutics (SPRO)는 2024년 3분기 재무 결과를 발표하며 1710만 달러의 순손실($0.32 per share)을 기록했으며, 이는 2023년 3분기의 320만 달러 손실과 비교됩니다. 매출은 지난해의 2550만 달러에서 1350만 달러로 감소했습니다. tebipenem HBr에 대한 3상 PIVOT-PO 시험은 2025년 하반기 내에 등록 완료를 목표로 하고 있습니다. SPR720 개발 중단과 39% 인력 감축 이후 현금 보유액은 7630만 달러로, 2026년 중반까지의 운영 자원을 확보하고 있습니다. 연구개발비는 1640만 달러에서 2690만 달러로 증가했으며, 관리비는 지난해 570만 달러에서 520만 달러로 감소했습니다.
Spero Therapeutics (SPRO) a annoncé les résultats financiers du troisième trimestre 2024, avec une perte nette de 17,1 millions de dollars (0,32 dollar par action), par rapport à une perte de 3,2 millions de dollars au troisième trimestre 2023. Les revenus ont chuté à 13,5 millions de dollars, contre 25,5 millions de dollars l'année précédente. L'essai de phase 3 PIVOT-PO pour le tebipenem HBr reste sur la bonne voie pour achever l'inscription au cours de la deuxième moitié de 2025. Suite à la suspension du développement de SPR720 et à une réduction de 39 % de la main-d'œuvre, la position de trésorerie s'établit à 76,3 millions de dollars, prolongeant la durée de financement jusqu'à mi-2026. Les dépenses en R&D ont augmenté à 26,9 millions de dollars, contre 16,4 millions de dollars, tandis que les dépenses générales et administratives ont diminué à 5,2 millions de dollars, contre 5,7 millions de dollars l'année précédente.
Spero Therapeutics (SPRO) hat die finanziellen Ergebnisse für das dritte Quartal 2024 bekannt gegeben, mit einem Nettoverlust von 17,1 Millionen Dollar (0,32 Dollar pro Aktie), im Vergleich zu einem Verlust von 3,2 Millionen Dollar im dritten Quartal 2023. Der Umsatz sank auf 13,5 Millionen Dollar, von 25,5 Millionen Dollar im Vorjahr. Die Phase-3-Studie PIVOT-PO für tebipenem HBr bleibt auf Kurs, um die Rekrutierung in der zweiten Hälfte von 2025 abzuschließen. Nach der Einstellung der Entwicklung von SPR720 und einer Reduzierung der Belegschaft um 39% beläuft sich die Liquiditätsposition auf 76,3 Millionen Dollar, was die finanzielle Pufferzeit bis Mitte 2026 verlängert. Die F&E-Ausgaben stiegen auf 26,9 Millionen Dollar, von 16,4 Millionen Dollar, während die Verwaltungs- und Gemeinkosten auf 5,2 Millionen Dollar sanken, von 5,7 Millionen Dollar im Vorjahr.
- Phase 3 PIVOT-PO trial for tebipenem HBr on track for enrollment completion
- Cash runway extended into mid-2026 following restructuring
- Strong cash position of $76.3 million
- Net loss increased to $17.1 million from $3.2 million year-over-year
- Revenue declined 47% to $13.5 million from $25.5 million
- R&D expenses increased 64% to $26.9 million
- 39% workforce reduction implemented
- SPR720 development suspended due to insufficient efficacy and safety concerns
Insights
The Q3 results reveal a challenging financial picture with a widened net loss of
The suspension of SPR720 development and
The pipeline update presents mixed signals. The Phase 3 PIVOT-PO trial for tebipenem HBr remains on track with a substantial enrollment target of 2,648 patients, demonstrating commitment to this key asset. However, the SPR720 program's suspension due to insufficient efficacy and safety concerns in the Phase 2a trial is a significant setback in the NTM-PD space.
The SPR206 program for MDR infections shows promise but depends on securing non-dilutive funding. This strategic prioritization of resources toward tebipenem HBr, backed by GSK, represents a more focused approach to drug development, though it reduces pipeline diversity.
Phase 3 PIVOT-PO trial of tebipenem HBr remains on track to complete enrollment in 2H 2025
Reiterate cash runway into mid-2026; Q3 2024 ending cash balance of
CAMBRIDGE, Mass., Nov. 14, 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 third quarter ended September 30, 2024, and provided a business update.
“Enrollment in the Phase 3 tebipenem HBr trial is progressing well, and we are on track to complete enrollment in the second half of 2025. Further, our work on the Phase 2 ready SPR206 program continues, contingent on availability of non-dilutive funding,” said Sath Shukla, President and Chief Executive Officer of Spero. “With SPR720 development plans now suspended while we complete a review of the full dataset from the Phase 2a trial, our extended cash runway into mid-2026 and streamlined operations position us well to achieve our ultimate goal of delivering new therapies to patients in need.”
Pipeline Update
Tebipenem HBr
Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI) including acute pyelonephritis (AP) to help patients potentially 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) has cleared the Company's IND for a Phase 2 trial in patients 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.
SPR720
SPR720 is an investigational oral, chemically stable phosphate ester prodrug that is converted rapidly in vivo to SPR719, the active moiety. SPR719 targets the ATPase site of DNA gyrase B in mycobacteria.
- In October 2024, a planned interim analysis of the Phase 2a proof-of-concept study of SPR720 for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD) demonstrated that the study did not meet its primary endpoint. While the data showed antimicrobial activity associated with SPR720, the interim analysis did not show sufficient separation from placebo and highlighted potential dose limiting safety issues in patients dosed at 1,000 mg orally once daily, including three cases of reversible grade 3 hepatotoxicity. In evaluating the totality of both the efficacy and safety data, the Company suspended its development program for SPR720 and will evaluate other potential paths forward as the remaining data are collected and analyzed.
Corporate Update
- In October 2024, following suspension of the current SPR720 development plans, Spero underwent a restructuring and reduction in force of approximately
39% , which extended the Company’s cash runway into mid-2026.
Third quarter 2024 Financial Results
- Spero reported a net loss of
$17.1 million , or ($0.32) per share of common stock, basic and diluted, for the third quarter ended September 30, 2024, compared with a net loss of$3.2 million , or ($0.06) per share of common stock, basic and diluted, for the third quarter ending September 30, 2023. - Total revenue for the third quarter of 2024 was
$13.5 million , compared with total revenue of$25.5 million for the third quarter of 2023. The revenue decrease for the third quarter of 2024 was primarily due to lower revenues related to ongoing collaborations. - Research and development expenses for the third quarter of 2024 were
$26.9 million , compared to$16.4 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 increased clinical trial expenses for PIVOT-PO. - General and administrative expenses for the third quarter of 2024 were
$5.2 million , compared to$5.7 million of general and administrative expenses for the same period in 2023. This year-over-year decrease was primarily due to decreased consulting and professional expenses. - As of September 30, 2024, Spero had cash and cash equivalents of
$76.3 million . Following the reduction in force and restructuring described above, Spero estimates that its existing cash and cash equivalents, together with earned and non-contingent development milestone payments from GSK, as well as other non-dilutive funding commitments, will be sufficient to fund its operating expenses and capital expenditures into mid-2026.
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.
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 are 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) | |||||
| September 30, | December 31, | ||||
| 2024 | 2023 | ||||
| Cash and cash equivalents | $ | 76,290 | $ | 76,333 | |
| Other assets | 58,871 | 106,057 | |||
| Total assets | $ | 135,161 | $ | 182,390 | |
| Total liabilities | 69,654 | 75,496 | |||
| Total stockholder's equity | 65,507 | 106,894 | |||
| Total liabilities and stockholders' equity | $ | 135,161 | $ | 182,390 | |
| Spero Therapeutics, Inc. | |||||||||||||||
| Condensed Consolidated Statements of Operations | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| (unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenues: | |||||||||||||||
| Grant revenue | $ | 5,650 | $ | 2,091 | $ | 14,893 | $ | 5,349 | |||||||
| Collaboration revenue - related party | 7,754 | 23,164 | 17,721 | 24,200 | |||||||||||
| Collaboration revenue | 65 | 218 | 319 | 710 | |||||||||||
| Total revenues | 13,469 | 25,473 | 32,933 | 30,259 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 26,864 | 16,393 | 67,921 | 34,883 | |||||||||||
| General and administrative | 5,198 | 5,708 | 16,648 | 19,121 | |||||||||||
| Impairment of long-term asset | — | 5,306 | — | 5,306 | |||||||||||
| Total operating expenses | 32,062 | 27,407 | 84,569 | 59,310 | |||||||||||
| Loss from operations | (18,593 | ) | (1,934 | ) | (51,636 | ) | (29,051 | ) | |||||||
| Other income (expense) | 1,156 | 940 | 3,668 | 2,877 | |||||||||||
| Net loss | (17,437 | ) | (994 | ) | (47,968 | ) | (26,174 | ) | |||||||
| Income tax expense | 290 | (2,211 | ) | 290 | (2,211 | ) | |||||||||
| Net loss | $ | (17,147 | ) | $ | (3,205 | ) | $ | (47,678 | ) | $ | (28,385 | ) | |||
| Net loss per share attributable to common shareholders per share, basic and diluted | $ | (0.32 | ) | $ | (0.06 | ) | $ | (0.89 | ) | $ | (0.54 | ) | |||
| Weighted average shares outstanding, basic and diluted: | 54,124,862 | 52,710,280 | 53,869,824 | 52,603,709 | |||||||||||
FAQ
What were Spero Therapeutics (SPRO) Q3 2024 financial results?
When will SPRO complete enrollment for the tebipenem HBr Phase 3 trial?
Why did SPRO suspend the SPR720 development program in October 2024?
How long will SPRO's current cash runway last?
