CAMBRIDGE, Mass. - Spero Therapeutics , Inc. (NASDAQ:SPRO) has announced the suspension of its SPR720 development program following an interim analysis that showed the drug did not meet its primary endpoint in a Phase 2a proof-of-concept study for the treatment of Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD). The analysis, which included data from 16 patients, revealed insufficient differentiation from placebo and potential dose-limiting safety issues, including cases of reversible grade 3 hepatotoxicity.
In response to these findings, Spero is undergoing a significant restructuring, including a workforce reduction of approximately 39%. This move is expected to extend the company's cash runway into mid-2026, as reported in their unaudited Q3 2024 financial results, which showed an ending cash balance of $76.3 million.
Despite the setback with SPR720, Spero continues to focus on advancing its other programs, including tebipenem HBr, which is in a global Phase 3 clinical trial for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). This trial, known as PIVOT-PO, is on track for enrollment completion in the second half of 2025.
Spero has also planned a Phase 2 clinical trial for SPR206, an investigational intravenously administered antibiotic, contingent on continued non-dilutive funding. The company has received significant financial support through its licensing agreement with GSK, which includes milestone payments and royalties on net product sales.
The company's president and CEO, Sath Shukla, expressed gratitude to the team and participants involved in the SPR720 study and reiterated Spero's commitment to developing new treatments for patients with high unmet needs.
The information in this article is based on a press release statement from Spero Therapeutics, Inc.
In other recent news, Spero Therapeutics has released promising results from a study on its investigational drug SPR719, showing a low tendency for resistance development in Mycobacterium avium Complex Pulmonary Disease (NTM-PD). The company also reported encouraging results from a Phase 1 trial of its drug candidate SPR720 for the treatment of NTM-PD, with no unexpected safety issues reported. On the financial front, Spero Therapeutics announced a rise in revenue to $10.2 million during its second quarter 2024, but also reported a net loss of $17.9 million.
Spero Therapeutics has seen some executive changes with the departure of their Chief Medical Officer and the appointment of Dr. John Pottage as interim clinical lead. The company also highlighted the progress of their lead assets SPR720, tebipenem-HBr, and SPR206, with the Phase 3 trial for tebipenem-HBr expected to complete enrollment in the second half of 2025. Despite a wider net loss in Q2 2024 compared to the same period in 2023, Spero Therapeutics maintains a strong cash position with $63.5 million in cash and cash equivalents.
H.C. Wainwright has reaffirmed a Buy rating on Spero Therapeutics, following the company's successful publication of their Phase 1 trial data. The trial demonstrated that SPR719 had significant lung uptake, indicating that the drug effectively targets the lung compartments critical for treating NTM-PD. These are some of the recent developments from Spero Therapeutics.
InvestingPro Insights
In light of Spero Therapeutics' recent announcement regarding the suspension of its SPR720 program and subsequent restructuring, InvestingPro data provides additional context for investors. Despite the setback, Spero maintains a strong financial position with a market capitalization of $69.72 million USD. The company's price-to-book ratio of 0.88 suggests that it may be undervalued relative to its assets, which could be of interest to value-oriented investors.
InvestingPro Tips highlight that Spero holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations. These factors may provide some reassurance to investors concerned about the company's financial stability during this transition period. Additionally, the company has been profitable over the last twelve months, with a P/E ratio of 3.22, indicating that it's trading at a relatively low multiple of its earnings.
However, it's important to note that analysts anticipate a sales decline in the current year, and net income is expected to drop. This aligns with the company's recent announcement and restructuring efforts. For investors seeking more comprehensive analysis, InvestingPro offers 9 additional tips that could provide further insights into Spero's financial health and future prospects.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.