Spero Therapeutics(US:SPRO)2024-11-14 21:02Financial Position - As of September 30, 2024, the company had an accumulated deficit of $438.8 million and cash and cash equivalents of $76.3 million[158]. - As of September 30, 2024, the company had cash and cash equivalents of $76.3 million, which is expected to fund operating expenses and capital requirements for at least 12 months[192]. - The company anticipates needing additional funding beyond the 12-month period, which may include equity or debt financings, new collaborations, or grant funding[192]. Revenue and Income - The company has not generated any revenue from product sales to date and cannot predict future revenue generation from product commercialization[167]. - Total revenues for the three months ended September 30, 2024, were $13.5 million, a decrease of $12.0 million compared to $25.5 million in the same period of 2023[177]. - Grant revenue for the three months ended September 30, 2024, was $5.7 million, an increase of $3.6 million from $2.1 million in the same period of 2023[177]. - Collaboration revenue from related parties decreased by $15.4 million to $7.8 million in the three months ended September 30, 2024, compared to $23.4 million in 2023[178]. - For the nine months ended September 30, 2024, total revenues were $32.9 million, an increase of $2.7 million from $30.3 million in 2023[181]. - Grant revenue for the nine months ended September 30, 2024, was $14.9 million, an increase of $9.5 million from $5.3 million in 2023[181]. - The company recognized $14.6 million in grant revenue from the BARDA contract for tebipenem HBr during the nine months ended September 30, 2024, an increase of $11.5 million from $3.1 million in 2023[181]. - Collaboration revenue for the nine months ended September 30, 2024, was $18.0 million, a decrease of $6.87 million from $24.9 million in the same period of 2023[182]. - The company recognized $17.7 million in collaboration revenue from GSK and $0.3 million from Pfizer for the nine months ended September 30, 2024[182]. Expenses - The company expects to incur significant expenses and increasing operating losses for at least the next several years[158]. - Research and development expenses primarily consist of costs related to drug discovery and development, with significant external costs tracked on a program-by-program basis[168]. - Research and development expenses increased by $10.5 million to $26.9 million for the three months ended September 30, 2024, compared to $16.4 million in 2023[179]. - Research and development expenses totaled $67.9 million for the nine months ended September 30, 2024, an increase of $33.04 million compared to $34.9 million for the same period in 2023[183]. - Direct costs for the tebipenem HBr program increased by $30.5 million during the nine months ended September 30, 2024, due to ongoing clinical activities[185]. - Total operating expenses for the three months ended September 30, 2024, were $32.1 million, an increase of $4.7 million from $27.4 million in 2023[177]. - General and administrative expenses decreased to $16.6 million for the nine months ended September 30, 2024, down by $2.47 million from $19.1 million in 2023[186]. Losses - The net loss for the three months ended September 30, 2024, was $17.1 million, an increase of $13.9 million from a net loss of $3.2 million in the same period of 2023[177]. - Net cash used in operating activities for the nine months ended September 30, 2024, was less than $0.1 million, compared to $15.5 million for the same period in 2023[188]. Strategic Restructuring - The strategic restructuring announced on October 29, 2024, included a workforce reduction of approximately 39%, with estimated costs of $1.1 million related to severance and termination benefits[160]. - The company anticipates a substantial reduction in future development-related expenses following the suspension of SPR720 and the implementation of its restructuring[173]. - The company plans to make reductions in spending if adequate additional funding is not secured, which may delay or eliminate planned clinical trials and research programs[192]. Clinical Development - The Phase 3 clinical trial for tebipenem HBr is on track, targeting enrollment of approximately 2,648 patients, with completion expected in the second half of 2025[163]. - An additional contract modification of $11.7 million was executed under the existing contract with BARDA, increasing total committed funding to $59.3 million for tebipenem HBr clinical development[164]. - The FDA cleared the investigational new drug application for SPR206, with plans to initiate a Phase 2 trial pending non-dilutive funding availability[165]. Future Outlook - Future cash requirements will depend on clinical trial costs, regulatory approvals, and potential collaborations[191]. - The company has no material changes to its contractual obligations and commitments during the three and nine months ended September 30, 2024[194]. - There are currently no off-balance sheet arrangements affecting the company[195]. - The primary objectives of the company's investment activities are to preserve principal, provide liquidity, and maximize income without significantly increasing risk[195]. - The company faces exposure to foreign currency exchange rate movements, primarily with the Euro, British Pound, Japanese Yen, and Australian Dollar against the U.S. dollar[195]. - Historically, foreign currency fluctuations have not had a material impact on the company's consolidated financial statements[195]. - The company does not have any assets classified as marketable securities as of September 30, 2024[195]. - The company is classified as a smaller reporting company and is not required to provide certain disclosures under SEC rules[195].