SPRO
Spero Therapeutics, INC
NASDAQ
8-K: Spero Therapeutics Announces Q1 2025 Results and Business Update; Tebipenem HBr Phase 3 Interim Analysis Expected in Q2
Sentiment:
Earnings Release
13 May 2025 4:49 PM
Spero Therapeutics reports Q1 2025 financial results and provides a business update, highlighting the upcoming interim analysis of the Phase 3 PIVOT-PO trial for tebipenem HBr.
Worse than expected
The company reported a higher net loss compared to the same quarter last year.
The company reported lower revenue compared to the same quarter last year.
Summary
- Spero Therapeutics announced its first quarter 2025 financial results, reporting a net loss of $13.9 million compared to a net loss of $12.7 million in the first quarter of 2024.
- Total revenue for Q1 2025 was $5.9 million, down from $9.3 million in Q1 2024, primarily due to a decrease in grant revenue, partially offset by higher collaboration revenue from GSK.
- Research and development expenses decreased to $13.6 million from $17.3 million year-over-year, mainly due to lower spending on the SPR720 program.
- General and administrative expenses increased to $6.8 million from $5.9 million year-over-year, driven by higher personnel-related costs and consulting fees.
- As of March 31, 2025, Spero had $48.9 million in cash and cash equivalents.
- The company anticipates that its existing cash, along with $23.75 million in milestone payments from GSK, will fund operations into Q2 2026.
- The pre-specified interim analysis of the Phase 3 PIVOT-PO clinical trial of tebipenem HBr in complicated urinary tract infection (cUTI) is on track to be completed in Q2 2025.
- Esther Rajavelu was appointed as Spero's President and Chief Executive Officer, effective May 2, 2025.
Sentiment
Score: 5
Explanation: The sentiment is neutral. While the company is progressing with its clinical trials and has sufficient funding into Q2 2026, the increased net loss and decreased revenue compared to the previous year are concerning. The suspension of the SPR720 program is also a negative factor.
Positives
- Spero anticipates that its existing cash and cash equivalents, together with upcoming $23.75M of earned and non-contingent development milestone payments from GSK will be sufficient to fund its operating expenses and capital expenditures into Q2 2026.
- The pre-specified interim analysis of the ongoing Phase 3 PIVOT-PO clinical trial of tebipenem HBr in complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), is on track to be completed in Q2 2025.
- Collaboration revenue increased due to the agreement with GSK.
Negatives
- Spero reported a net loss of $13.9 million for the first quarter of 2025, which is higher than the $12.7 million loss in the first quarter of 2024.
- Total revenue for the first quarter of 2025 decreased to $5.9 million from $9.3 million in the first quarter of 2024.
- The oral development program in NTM-PD was suspended in 4Q 2024 after a Phase 2a study did not meet its primary endpoint.
Risks
- The company's future depends on the success of tebipenem HBr, and its development is subject to regulatory delays, patient enrollment challenges, and clinical trial outcomes.
- Spero relies on GSK for the development and commercialization of tebipenem HBr, and GSK has the right to determine whether to continue the PIVOT-PO trial.
- Spero may need additional funding to continue its operations beyond Q2 2026.
- The company faces risks related to commercializing its product candidates and retaining key personnel.
Future Outlook
Spero anticipates that its existing cash and cash equivalents, together with upcoming milestone payments from GSK, will be sufficient to fund its operating expenses and capital expenditures into Q2 2026. The company is focused on the successful execution of the tebipenem HBr clinical program and the upcoming interim analysis of the PIVOT-PO trial.
Management Comments
- At Spero, our top priority remains the successful execution of the tebipenem HBr clinical program as we prepare for the pre-specified interim analysis of the PIVOT-PO trial during the second quarter, said Esther Rajavelu, President and Chief Executive Officer.
- We are developing tebipenem HBr to address the significant unmet need for an oral carbapenem option in the treatment of complicated urinary tract infections.
- We believe that, if approved, tebipenem HBr could deliver meaningful clinical and economic benefits, by improving patient outcomes and reducing the need for hospital stays.
Industry Context
Spero Therapeutics is focused on developing novel treatments for multi-drug resistant bacterial infections, an area of increasing concern in the healthcare industry. The development of tebipenem HBr, an oral carbapenem antibiotic, addresses the need for outpatient treatment options for complicated urinary tract infections, potentially reducing hospital stays and healthcare costs.
Comparison to Industry Standards
- The Phase 3 PIVOT-PO trial compares oral tebipenem HBr with intravenous imipenem-cilastatin, a standard treatment for cUTI/AP.
- If approved, tebipenem HBr would compete with existing IV carbapenems but offer the advantage of oral administration, similar to how oral antibiotics like ciprofloxacin and levofloxacin compete with IV antibiotics for less severe infections.
- Companies like Nabriva Therapeutics (which markets oral antibiotic Xenleta) and Melinta Therapeutics (which markets Baxdela) also target bacterial infections with novel antibiotics, but tebipenem HBr's carbapenem class could offer a different spectrum of activity and resistance profile.
Stakeholder Impact
- Shareholders: The financial results and clinical trial progress will impact shareholder value.
- Employees: The company's financial stability and strategic direction will affect employee job security and opportunities.
- Patients: The development of tebipenem HBr could provide a new treatment option for complicated urinary tract infections.
- GSK: The collaboration with GSK is crucial for the development and commercialization of tebipenem HBr.
Next Steps
- Completion of the pre-specified interim analysis of the Phase 3 PIVOT-PO clinical trial of tebipenem HBr in Q2 2025.
- Analysis of the data from all 25 patients dosed in the Phase 2a proof-of-concept study in NTM-PD to determine next steps for the program.
- Spero's 2025 annual meeting of stockholders, where Esther Rajavelu has been nominated for election to the Board of Directors.
Key Dates
- 2024: Oral development program in NTM-PD was suspended in 4Q 2024.
- March 31, 2025: End of first quarter 2025; Spero had $48.9 million in cash and cash equivalents.
- May 2, 2025: Esther Rajavelu appointed as Spero's President and Chief Executive Officer.
- May 13, 2025: Date of the 8-K filing and press release announcing Q1 2025 results.
- Q2 2025: Expected completion of the pre-specified interim analysis of the Phase 3 PIVOT-PO clinical trial of tebipenem HBr.
- Q2 2026: Spero estimates its existing cash and cash equivalents, together with upcoming milestone payments from GSK, will be sufficient to fund its operating expenses and capital expenditures into Q2 2026.
Keywords
Spero Therapeutics, Tebipenem HBr, PIVOT-PO, GSK, Clinical Trial, Financial Results, Q1 2025, cUTI, SPR720
SPRO
Spero Therapeutics, INC
NASDAQ
Sector: TBD
Filings with Classifications
Better than expected
28 May 2025 7:12 AM
Clinical Trial Results
- The Phase 3 PIVOT-PO trial met its primary endpoint of non-inferiority.
- The trial was stopped early for efficacy, indicating stronger-than-anticipated positive results.
- No new safety concerns were identified, reinforcing the drug's safety profile.
Worse than expected
13 May 2025 4:49 PM
Earnings Release
- The company reported a higher net loss compared to the same quarter last year.
- The company reported lower revenue compared to the same quarter last year.
Worse than expected
13 May 2025 4:15 PM
Quarterly Report
- The company's net loss increased compared to the same period last year.
- There is substantial doubt about the company's ability to continue as a going concern.
- The company received a Nasdaq deficiency letter due to its stock price falling below $1.00.
Capital raise
13 May 2025 4:15 PM
Quarterly Report
- The company expects that it will need substantial additional funding.
- The company will seek additional funding through public or private financings, debt financing, collaboration agreements, government grants or other sources.
- The company has a universal shelf registration statement on Form S-3 with the SEC on March 15, 2024, which became effective on March 22, 2024, and pursuant to which the company registered for sale up to $300.0 million of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the company may determine, including up to $75.0 million of its common stock available for issuance pursuant to a Controlled Equity Offering Sales Agreement (the Sales Agreement) with Cantor Fitzgerald & Co. (Cantor).
Worse than expected
27 March 2025 5:19 PM
Earnings Release and Business Update
- The company reported a net loss of $(20.9) million for Q4 2024 compared to a net income of $51.2 million for Q4 2023.
- Total revenue for Q4 2024 was $15.0 million, compared with total revenue of $73.5 million for the fourth quarter of 2023.
- The company discontinued the SPR206 program following a pipeline review in Q1 2025.
Capital raise
27 March 2025 4:30 PM
Annual Results
- Spero expects to need additional funding beyond the second quarter of 2026.
- The company expects that additional funding will primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations or additional grant funding.
Worse than expected
27 March 2025 4:30 PM
Annual Results
- The company's auditor has expressed substantial doubt about its ability to continue as a going concern.
- The company has suspended development of SPR720 and discontinued SPR206.
- The company is subject to an SEC investigation regarding certain public disclosures made in 2022.
Worse than expected
28 February 2025 5:11 PM
8-K Filing
- The company's stock price falling below the Nasdaq minimum bid price requirement is worse than expected.
Worse than expected
10 January 2025 7:00 AM
Corporate Update
- The company is facing an SEC investigation, which is a negative development.
- The company has made interim leadership changes, which can create uncertainty.
- The company has suspended development of SPR720 after a Phase 2a trial did not meet its primary endpoint and showed potential safety issues.
Worse than expected
14 November 2024 4:05 PM
Quarterly Report
- The company reported a significantly larger net loss in Q3 2024 compared to Q3 2023.
- The company's revenue decreased substantially in Q3 2024 compared to Q3 2023.
- The company suspended the development of SPR720 after a Phase 2a trial failed to meet its primary endpoint.
Delay expected
14 November 2024 4:02 PM
Quarterly Report
- The suspension of the SPR720 program will delay the development of a potential treatment for NTM-PD.
Capital raise
14 November 2024 4:02 PM
Quarterly Report
- The company expects to need additional funding beyond mid-2026, which will primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations, additional grant funding and/or reducing cash expenditures.
- The company has a universal shelf registration statement on Form S-3, which allows it to sell up to $300 million of securities, including up to $75 million of common stock through an at-the-market offering program.
Worse than expected
14 November 2024 4:02 PM
Quarterly Report
- The company suspended the development of SPR720 due to the Phase 2a trial not meeting its primary endpoint and potential safety issues.
Worse than expected
29 October 2024 5:01 PM
Business Update
- The Phase 2a trial of SPR720 failed to meet its primary endpoint, leading to the suspension of the program.
- The company is undergoing a restructuring and workforce reduction due to the disappointing trial results.
Capital raise
5 August 2024 4:18 PM
Quarterly Report
- The company expects to need additional funding beyond late 2025, which will primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations, or additional grant funding.
- The company has a universal shelf registration statement on Form S-3, which allows for the sale of up to $300 million of securities, including common stock.
Worse than expected
5 August 2024 4:18 PM
Quarterly Report
- The company reported a net loss of $30.5 million for the first half of 2024, indicating ongoing financial challenges.
Worse than expected
5 August 2024 4:13 PM
Quarterly Report
- The company's net loss increased significantly compared to the same quarter last year, indicating worse than expected financial performance.
Capital raise
15 May 2024 4:02 PM
Quarterly Report
- The company expects to need additional funding beyond late 2025, which they anticipate will primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations or additional grant funding.
- Spero has filed a new universal shelf registration statement on Form S-3 with the SEC, registering for sale up to $300.0 million of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units.
Worse than expected
15 May 2024 4:02 PM
Quarterly Report
- The company reported a net loss of $12.7 million, which is a significant loss for the quarter, although slightly better than the $13.3 million loss in the same period last year.
Better than expected
13 March 2024 4:07 PM
Annual Results
- The company reported a net income of $22.8 million for 2023, a significant improvement from the $46.4 million loss in 2022.
- Revenue increased substantially to $103.8 million in 2023, compared to $53.5 million in 2022.
- The company's cash runway is expected to extend into late 2025, providing financial stability.
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