Spero Therapeutics Announces First Quarter 2024 Operating Results and Provides a Business Update
Spero Therapeutics (Nasdaq: SPRO) reported its Q1 2024 financial results and provided a business update. The company continues advancing its clinical pipeline, with key trials underway. Topline data for SPR720, aimed at treating NTM-PD, is expected in 2H 2024. The Phase 3 trial for tebipenem HBr in cUTI is ongoing, with enrollment completion targeted for 2H 2025. SPR206 received FDA Fast Track designation for HABP/VABP treatment.
Spero reported a net loss of $12.7 million for Q1 2024, a slight improvement from $13.3 million a year ago. Revenue surged to $9.3 million, primarily due to increased collaboration and grant revenues. R&D expenses rose to $17.3 million, reflecting heightened clinical activity. G&A expenses decreased to $5.9 million. The company's cash balance stands at $82.3 million, up from $76.3 million at year-end 2023, bolstered by a $23.8 million milestone payment from GSK. Spero's financial runway is expected to extend into late 2025.
- Revenue increased to $9.3 million in Q1 2024 from $2.1 million in Q1 2023.
- Cash balance rose to $82.3 million as of March 31, 2024, up from $76.3 million at the end of 2023.
- SPR206 received FDA Fast Track designation for treating HABP/VABP.
- Topline data for SPR720 expected in 2H 2024, representing potential for new NTM-PD treatments.
- Enrollment in Phase 3 trial for tebipenem HBr expected to complete in 2H 2025, targeting cUTI.
- Anticipated cash runway extended into late 2025.
- Net loss of $12.7 million in Q1 2024, marginally better than $13.3 million in Q1 2023.
- R&D expenses increased to $17.3 million from $9.0 million, reflecting higher clinical activity.
- Decrease in grant revenue under NIAID agreement for SPR206.
- Ongoing need for non-dilutive funding for Phase 2 SPR206 clinical trial.
Insights
The first quarter of 2024 indicates several positive financial metrics for Spero Therapeutics. The net loss of
The collaboration with GSK, clearly monetizing into milestone payments, underscores strong strategic partnerships, adding credibility and financial backing. However, investors should remain vigilant over the elevated R&D expenses, particularly if clinical trials face delays or do not yield expected results. The long-term financial health largely depends on successful trials and subsequent commercialization of their leading drug candidates. The prudent use of available cash reserves and strategic management of upcoming expenses will be important metrics to watch in the subsequent quarters.
Spero Therapeutics is progressing well in its clinical trials, particularly with SPR720 and tebipenem HBr. The anticipated top-line data from the Phase 2a trial of SPR720 in the second half of 2024 is critical. SPR720 aims to treat non-refractory NTM-PD patients, a niche market with significant unmet medical needs. The trial's primary endpoint focuses on bacterial load reduction, while secondary endpoints include clinical response and quality of life—key factors for FDA approval and adoption in clinical practice. Positive outcomes here could significantly enhance the company's valuation and market position.
The ongoing Phase 3 PIVOT-PO trial for tebipenem HBr is another major clinical endeavor. With this trial targeting completion in the second half of 2025, achieving the primary endpoint of clinical cure and favorable microbiological response at the Test-of-Cure visit would position tebipenem HBr as the first oral carbapenem for cUTI, a substantial market opportunity. Moreover, the FDA Fast Track designation for SPR206 is a strategic milestone, expediting the development of treatments for HABP/VABP due to MDR pathogens. This designation highlights the critical need for such antibiotics, potentially accelerating regulatory pathways and market entry.
Overall, while the clinical trials are progressing well, they inherently carry risks of phase failures or suboptimal results. Investors should monitor trial updates closely, particularly the primary and secondary endpoints, to gauge the likelihood of successful commercialization and revenue generation.
- On track for topline data from SPR720 Phase 2a proof-of-concept trial in treatment-naive and treatment-experienced non-refractory NTM-PD patients, expected in 2H 2024
- Enrollment ongoing in PIVOT-PO, a pivotal Phase 3 clinical trial of oral tebipenem HBr in cUTI
- Received FDA Fast Track designation for SPR206 for treatment of HABP/VABP due to CRABc and CRPA
- Cash balance of
$82.3 million as of March 31, 2024; reiterate expected cash runway into late 2025
CAMBRIDGE, Mass., May 15, 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 and operational results for the quarter ended March 31, 2024.
“We continued to make progress towards our stated goals across our clinical pipeline, in both our wholly-owned and partnered programs,” stated Sath Shukla, President and Chief Executive Officer of Spero. “Anticipated top-line data from the Phase 2a clinical trial of SPR720 in the second half of 2024 continues to present an exciting potential opportunity to redefine the standard of care in nontuberculous mycobacterial pulmonary disease (NTM-PD). Additionally, tebipenem HBr as the potential first oral carbapenem for complicated urinary tract infection (cUTI) continues to enroll patients globally in our Phase 3 PIVOT-PO clinical trial, with enrollment completion anticipated in the second half of 2025. Supported by a strong balance sheet, Spero remains well capitalized with expected cash runway into late 2025.”
Pipeline Update
SPR720
SPR720 is an investigational, novel, oral, first-line treatment for NTM-PD.
- Top-line data from the Phase 2a proof-of-concept clinical trial are expected in 2H 2024. The trial is expected to enroll treatment-naïve or treatment-experienced participants with non-refractory NTM-PD due to Mycobacterium avium complex. The primary endpoint evaluates changes in bacterial load in sputum samples from baseline to the end of the 56-day treatment period. Key secondary endpoints include assessments of clinical response, quality of life, pharmacokinetics, and safety and tolerability. For more information on the trial, see ClinicalTrials.gov identifier NCT05496374.
Tebipenem HBr
Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of 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 continues in PIVOT-PO, a global, randomized, double-blind, Phase 3 clinical trial of tebipenem HBr in patients with cUTI. The trial compares oral tebipenem HBr with intravenous imipenem cilastatin, in hospitalized adult patients with cUTI/AP. The primary endpoint is overall response, which is a combination of clinical cure and favorable microbiological response, at the Test-of-Cure (TOC) visit. The trial is expected to enroll approximately 2,648 patients, with enrollment completion targeted for 2H 2025. For more information on PIVOT-PO, refer to ClinicalTrials.gov ID NCT06059846.
SPR206
SPR206 is an innovative, investigational, intravenously administered direct-acting 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.
- In February 2024, the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application to advance SPR206 into a Phase 2 clinical trial in participants with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP).
- In March 2024, SPR206 received Fast Track designation by the FDA for treatment of HABP/VABP due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex ("CRABc") and carbapenem-resistant Pseudomonas aeruginosa ("CRPA"). The Company plans to initiate a Phase 2 clinical trial contingent on availability of non-dilutive funding.
First Quarter 2024 Financial Results
- Spero reported a net loss of
$12.7 million , or ($0.24) per share of common stock, basic and diluted, for the first quarter ended March 31, 2024, compared with a net loss of$13.3 million , or ($0.25) per share of common stock, basic and diluted, for the first quarter ended March 31, 2023. - Total revenue for the first quarter of 2024 was
$9.3 million , compared with total revenue of$2.1 million for the first quarter of 2023. The revenue increase for the first 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. - Research and development expenses for the first quarter of 2024 were
$17.3 million , compared to$9.0 million for the same period in 2023. The year-over-year increase was primarily due to increased clinical activity during the period related to the ongoing Phase 2a clinical trial of SPR720 and the pivotal Phase 3 trial of tebipenem HBr, offset by lower expenses related to SPR206 and lower R&D personnel-related costs. - General and administrative expenses for the first quarter of 2024 were
$5.9 million , compared to$7.3 million for the same period in 2023. The year-over-year decrease was primarily due to decreases in G&A personnel-related costs, professional and consulting fees, and facility-related expenses. - As of March 31, 2024, Spero had cash and cash equivalents of
$82.3 million , compared to$76.3 million at December 31, 2023. The increase in the cash balance was a result of the receipt of$23.8 million milestone payment from GSK, the first of four equal tranches of the$95.0 million development milestones that Spero earned upon first patient enrollment in the tebipenem HBr Phase 3 PIVOT-PO trial. The increase was partially offset by cash operating expenses in the quarter. - 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.
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.
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.
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.
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
Forward Looking Statements
This press release may contain forward-looking statements. These statements include, but are not limited to, statements about the design, initiation, timing, progress and results of Spero's preclinical studies and clinical trials and its research and development programs, as well as the regulatory path forward for tebipenem HBr and potential FDA approval, the potential commercialization of tebipenem HBr, the potential receipt under the GSK license agreement of milestone payments and royalties on future sales of tebipenem HBr, and Spero's cash runway. In some cases, forward-looking statements can be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. Actual results may differ materially from those indicated by such forward looking statements as a result of various important factors, 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 ongoing 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 as of the date of this press release. Spero anticipates that subsequent events and developments will cause its views to change. However, while Spero may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spero's views as of any date subsequent to the date of this press release.
Investor Relations Contact:
Ashley R. Robinson
Managing Director, LifeSci Advisors, LLC
arr@lifesciadvisors.com
(617) 775-5956
Media Inquiries:
media@sperotherapeutics.com
| Spero Therapeutics, Inc. | |||||||
| Condensed Consolidated Balance Sheet Data | |||||||
| (in thousands) | |||||||
| (Unaudited) | |||||||
| March 31, | December 31, | ||||||
| 2024 | 2023 | ||||||
| Cash and cash equivalents | $ | 82,271 | $ | 76,333 | |||
| Other assets | 85,432 | 106,057 | |||||
| Total assets | $ | 167,703 | $ | 182,390 | |||
| Total liabilities | 71,454 | 75,496 | |||||
| Total stockholder's equity | 96,249 | 106,894 | |||||
| Total liabilities and stockholders' equity | $ | 167,703 | $ | 182,390 | |||
| Spero Therapeutics, Inc. | |||||||
| Condensed Consolidated Statements of Operations | |||||||
| (in thousands, except share and per share data) | |||||||
| (unaudited) | |||||||
| Three Months Ended March 31, | |||||||
| 2024 | 2023 | ||||||
| Revenues: | |||||||
| Grant revenue | $ | 5,063 | $ | 1,329 | |||
| Collaboration revenue - related party | 4,064 | 517 | |||||
| Collaboration revenue | 140 | 223 | |||||
| Total revenues | 9,267 | 2,069 | |||||
| Operating expenses: | |||||||
| Research and development | 17,332 | 8,979 | |||||
| General and administrative | 5,917 | 7,317 | |||||
| Total operating expenses | 23,249 | 16,296 | |||||
| Loss from operations | (13,982 | ) | (14,227 | ) | |||
| Other income (expense) | 1,313 | 961 | |||||
| Net loss | (12,669 | ) | (13,266 | ) | |||
| Net loss attributable to common shareholders of Spero Therapeutics, Inc. | $ | (12,669 | ) | $ | (13,266 | ) | |
| Net loss per share attributable to common shareholders per share, basic and diluted | $ | (0.24 | ) | $ | (0.25 | ) | |
| Weighted average shares outstanding, basic and diluted: | 53,524,037 | 52,527,018 | |||||
FAQ
What is the expected timeline for SPR720's topline data?
What stages are Spero Therapeutics' key clinical trials in?
How did Spero Therapeutics perform financially in Q1 2024?
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What is the significance of the FDA Fast Track designation for SPR206?
