SPRO
Spero Therapeutics, INC
NASDAQ
8-K: Spero Therapeutics Announces Q2 2024 Results and Provides Business Update, Including Key Clinical Trial Milestones
Sentiment:
Quarterly Report
5 August 2024 4:13 PM
Spero Therapeutics reported its second quarter 2024 financial results and provided a business update, highlighting the completion of enrollment in a Phase 2a trial for SPR720 and progress in the Phase 3 trial for tebipenem HBr.
Worse than expected
The company's net loss increased significantly compared to the same quarter last year, indicating worse than expected financial performance.
Summary
- Spero Therapeutics announced its second quarter 2024 financial results, reporting a net loss of $17.9 million, or ($0.33) per share, compared to a net loss of $11.9 million, or ($0.23) per share, for the same period in 2023.
- Total revenue for the quarter was $10.2 million, up from $2.7 million in the second quarter of 2023, primarily due to increased collaboration revenue from the GSK agreement for tebipenem HBr and increased grant revenue related to the BARDA contract.
- Research and development expenses increased to $23.7 million from $9.5 million year-over-year, driven by costs associated with the Phase 3 trial for tebipenem HBr and the Phase 2a trial for SPR720.
- The company's cash balance was $63.5 million as of June 30, 2024, and they expect this, along with other non-dilutive funding, to support operations into late 2025.
- Enrollment has concluded in the Phase 2a proof-of-concept clinical trial for SPR720 in nontuberculous mycobacterial pulmonary disease (NTM-PD), with preliminary data expected in the fourth quarter of 2024.
- The company is on track with enrollment in the global Phase 3 PIVOT-PO clinical trial for tebipenem HBr, with completion expected in the second half of 2025.
- Spero announced the departure of its Chief Medical Officer, Kamal Hamed, and appointed John C. Pottage, Jr., as Special Advisor to oversee the medical function while a search for a new CMO is underway.
Sentiment
Score: 6
Explanation: The sentiment is moderately positive due to the progress in clinical trials and revenue growth, but tempered by the increased net loss and the departure of the CMO. The company's cash runway is a positive, but the need for future funding is a concern.
Positives
- Spero's revenue increased significantly year-over-year, driven by collaboration and grant revenue.
- The company has a solid cash position of $63.5 million, expected to fund operations into late 2025.
- Enrollment completion in the SPR720 Phase 2a trial is a positive milestone, with data expected soon.
- The Phase 3 trial for tebipenem HBr is progressing as planned.
- The appointment of John C. Pottage, Jr., as Special Advisor provides experienced oversight of the medical function.
- The company has a diversified clinical-stage portfolio with multiple assets in development.
Negatives
- Spero reported a net loss of $17.9 million for the second quarter of 2024, an increase from the $11.9 million loss in the same period of 2023.
- Research and development expenses have increased significantly year-over-year.
- The departure of the Chief Medical Officer creates a leadership gap.
- The Phase 2 trial for SPR206 is contingent on securing non-dilutive funding.
Risks
- The company's financial performance is subject to the risks associated with clinical trials, regulatory approvals, and commercialization of its product candidates.
- Spero is dependent on raising additional capital to fund its operations.
- There are risks associated with the reliance on third parties for manufacturing, development, and commercialization.
- The company faces competition from other pharmaceutical companies developing treatments for similar indications.
- The success of clinical trials is not guaranteed, and results may not be indicative of future outcomes.
- Regulatory approvals may be delayed or not granted, impacting the commercial prospects of the company's product candidates.
Future Outlook
Spero expects its cash and cash equivalents, along with other non-dilutive funding, to be sufficient to fund its operating expenses and capital expenditure requirements into late 2025. The company anticipates reporting preliminary data from the SPR720 Phase 2a trial and topline results from two Phase 1 studies in 4Q 2024. Enrollment in the tebipenem HBr Phase 3 trial is expected to complete in the second half of 2025.
Management Comments
- Sath Shukla, President and Chief Executive Officer of Spero, stated that the company's pipeline continues to advance as planned.
- Mr. Shukla expressed hope that SPR720 and Tebipenem could become meaningfully differentiated treatment options for patients.
- Mr. Shukla thanked Kamal Hamed for his contributions and expressed confidence in Dr. Pottage's oversight of the clinical programs.
Industry Context
This announcement comes as the pharmaceutical industry continues to focus on developing new treatments for infectious diseases, particularly those caused by multi-drug resistant bacteria. Spero's focus on novel treatments for rare diseases and MDR bacterial infections aligns with this trend. The company's progress in clinical trials and partnerships with companies like GSK are significant in this context.
Comparison to Industry Standards
- Spero's focus on oral antibiotics like tebipenem HBr aligns with a broader industry trend to move away from intravenous treatments, which can be more costly and require hospitalization. Companies like Achaogen (now defunct) and Paratek Pharmaceuticals have also pursued oral antibiotics for serious infections, but Spero's approach with a carbapenem is unique.
- The development of SPR720 for NTM-PD is notable as there are limited approved first-line therapies for this condition. Insmed's Arikayce is an inhaled treatment for NTM-PD, making Spero's oral approach a potential differentiator.
- The Phase 3 trial for tebipenem HBr is a large, global study, which is typical for late-stage drug development. The trial's design, including the use of a non-inferiority endpoint, is consistent with regulatory requirements for antibiotic approvals.
- Spero's financial results, while showing increased revenue, also highlight the high costs associated with drug development, which is common in the biopharmaceutical industry. The company's cash runway into late 2025 is a positive sign, but continued funding will be necessary.
Stakeholder Impact
- Shareholders may be concerned about the increased net loss but encouraged by the revenue growth and clinical trial progress.
- Employees may experience uncertainty due to the leadership transition but benefit from the company's continued operations.
- Patients may benefit from the potential development of new treatments for NTM-PD and cUTI.
- Partners like GSK may be encouraged by the progress of the tebipenem HBr program.
Next Steps
- Spero will present new SPR720 in-vitro resistance data at the IDWeek 2024 conference in October.
- The company expects to report preliminary data from the Phase 2a trial of SPR720 in 4Q 2024.
- Topline results from two Phase 1 clinical studies evaluating SPR720 are also expected in 4Q 2024.
- Spero will continue enrollment in the Phase 3 PIVOT-PO trial for tebipenem HBr, with completion expected in the second half of 2025.
- The company will continue its search for a new Chief Medical Officer.
Key Dates
- August 5, 2024: Date of the 8-K filing and press release announcing Q2 2024 results and business update.
- August 29, 2024: Effective date of departure for Chief Medical Officer, Kamal Hamed.
- October 16 to 19, 2024: IDWeek 2024 conference where new SPR720 in-vitro resistance data will be presented.
- 4Q 2024: Expected release of preliminary data from the Phase 2a trial of SPR720 and topline results from two Phase 1 clinical studies evaluating SPR720.
- Second half of 2025: Expected completion of enrollment in the Phase 3 PIVOT-PO clinical trial for tebipenem HBr.
Keywords
Spero Therapeutics, SPR720, Tebipenem HBr, SPR206, NTM-PD, cUTI, Clinical Trials, Phase 2a, Phase 3, Antibiotics, Infectious Diseases, Biopharmaceutical, Drug Development, Financial Results
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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