Financial Position - Estimated cash and cash equivalents as of December 31, 2024, are approximately $52.9 million[4]. - The company expects its existing cash and cash equivalents, along with non-contingent development milestone payments from GSK, to fund operations into mid-2026[4]. - The complete quarterly results will be included in the Annual Report on Form 10-K for the year ended December 31, 2024[5]. - The company has not yet finalized its financial statements for the year ended December 31, 2024, and the preliminary data may change[5]. Leadership Changes - Interim leadership changes include Esther Rajavelu appointed as Interim President and CEO, with additional cash compensation of $20,000 per month[19]. - Frank Thomas has been appointed as Chairman of the Board, replacing Ankit Mahadevia[19]. - Satyavrat Shukla is on paid administrative leave pending the resolution of the SEC investigation[19]. SEC Investigation - The company is under investigation by the SEC regarding public disclosures related to the cessation of commercialization of tebipenem HBr[10]. - The company intends to vigorously defend against the SEC's Wells Notice and maintain that its disclosures were appropriate[13]. Investor Relations - The company has updated its investor presentation as of January 10, 2025, which is available on its website[8].

Tebipenem HBr Development - Tebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), with the potential to reduce hospitalizations or shorten in-patient therapy [1] - The Phase 3 PIVOT-PO trial for Tebipenem HBr, a global randomized, double-blind study comparing its efficacy with intravenous imipenem cilastatin, began enrolling patients in January 2024 and aims to enroll approximately 2,648 participants, with full enrollment expected by the second half of 2025 [5][14] - As of December 31, 2024, over 60% of the enrollment target for the PIVOT-PO trial has been achieved [14] SPR720 and SPR206 Programs - SPR720 is an oral prodrug converted to SPR719, targeting the ATPase site of DNA gyrase B in mycobacteria, offering a distinct mechanism for treating Non-Tuberculous Mycobacterial-Pulmonary Disease (NTM-PD) [2] - A Phase 2a proof-of-concept trial for SPR720 concluded enrollment in July 2024 with 25 patients, but interim analysis indicated it did not meet its primary endpoint, and safety data highlighted potential dose-limiting issues [14] - SPR206, an investigational intravenous polymyxin, has shown activity against multidrug-resistant (MDR) Gram-negative pathogens and received FDA clearance for a Phase 2 trial in hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), contingent on non-dilutive funding [8] Leadership and Corporate Updates - Esther Rajavelu was appointed Interim President and CEO, and Frank Thomas was named Chairman of the Board, following leadership changes in response to a Wells Notice from the SEC related to 2022 disclosures [9][10] - The company maintains that its disclosures were appropriate and is cooperating with the SEC, intending to vigorously defend against the matter [4][10] - The Board expressed confidence in the interim leadership and the company's strategy to advance its pipeline, including the Tebipenem HBr program [7] Financial and Operational Guidance - As of December 31, 2024, the company had $52.9 million in cash and cash equivalents, with a cash runway extending into mid-2026, supported by non-dilutive funding commitments and milestone payments from GSK [13] - The company remains focused on advancing its Tebipenem HBr clinical program and other ongoing activities, leveraging its financial resources to maintain operational momentum [7][13] Research and Development Support - Select studies for Tebipenem HBr and SPR206 have received funding from federal agencies, including the Department of Health and Human Services and the Department of Defense, highlighting the strategic importance of these programs [6][16][22]

Core Viewpoint - Spero Therapeutics, Inc. (SPRO) is experiencing a downtrend with a 9.3% decline over the past four weeks, but it is in oversold territory, suggesting a potential turnaround due to analysts' positive earnings outlook [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 indicating oversold conditions [2] - SPRO's current RSI reading is 27.37, suggesting that the heavy selling pressure may be exhausting, indicating a possible price rebound [5] Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts regarding SPRO, with a 6.3% increase in the consensus EPS estimate over the last 30 days, which typically correlates with price appreciation [6] - SPRO holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a near-term turnaround [7]

Core Viewpoint - Spero Therapeutics reported a quarterly loss of $0.32 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.27, marking an earnings surprise of -18.52% [1] Financial Performance - The company posted revenues of $13.47 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 41.44%, and down from $25.47 million in the same quarter last year [2] - Over the last four quarters, Spero Therapeutics has surpassed consensus EPS estimates two times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.21 on revenues of $9 million, and for the current fiscal year, it is -$1.38 on revenues of $51.5 million [7] Stock Performance - Spero Therapeutics shares have declined approximately 10.9% since the beginning of the year, contrasting with the S&P 500's gain of 25.5% [3] - The stock currently holds a Zacks Rank 2 (Buy), indicating expectations of outperforming the market in the near future [6] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Spero Therapeutics belongs, is currently in the top 29% of over 250 Zacks industries, suggesting a favorable outlook [8]

Financial Position - Estimated cash and cash equivalents of approximately $76.3 million as of September 30, 2024[2] - Existing cash and cash equivalents expected to fund operating expenses and capital expenditures into mid-2026[5] Workforce and Restructuring - Company announced a workforce reduction of approximately 39% to refocus on strategic priorities around tebipenem HBr and R&D efforts[4] - Estimated restructuring charges of approximately $1.1 million related to severance pay and termination benefits[5] - Company may incur additional costs related to the workforce reduction not currently contemplated[5] Business Operations and Strategy - Company released an investor presentation providing updates on business and operations[6] - Company emphasizes reliance on third parties for manufacturing and commercialization of product candidates[11] Forward-Looking Statements - Forward-looking statements indicate potential regulatory delays and the need for additional funding[9] - Anticipated expenses and cash runway are subject to various important factors that may affect actual results[9] - Completion of quarterly results will be included in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024[3]

Core Viewpoint - Spero Therapeutics is progressing well with its Phase 3 PIVOT-PO trial of tebipenem HBr, expecting to complete enrollment in the second half of 2025, while also managing its financial resources effectively to extend its cash runway into mid-2026 [1][2][10]. Pipeline Update - Tebipenem HBr is an investigational oral carbapenem antibiotic aimed at treating complicated urinary tract infections (cUTI), potentially reducing hospitalizations [3][4]. - The PIVOT-PO trial is a randomized, double-blinded study comparing oral tebipenem HBr with intravenous imipenem cilastatin, targeting approximately 2,648 patients [4]. - SPR206 is another investigational drug showing activity against multi-drug resistant Gram-negative pathogens, with plans for a Phase 2 trial pending funding [5][6]. Financial Results - For Q3 2024, Spero reported a net loss of $17.1 million, or ($0.32) per share, compared to a net loss of $3.2 million, or ($0.06) per share in Q3 2023 [10][18]. - Total revenue for Q3 2024 was $13.5 million, down from $25.5 million in Q3 2023, primarily due to lower collaboration revenues [10][18]. - Research and development expenses increased to $26.9 million in Q3 2024 from $16.4 million in the same period in 2023, attributed to higher clinical trial costs [10][18]. Corporate Update - Following the suspension of the SPR720 development program, Spero underwent a restructuring that included a 39% reduction in workforce, which has extended its cash runway into mid-2026 [9][10].

Financial 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].

CAMBRIDGE, Mass., July 29, 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 that management will host a conference call and live audio webcast on Monday August 5th, 2024 at 4:30 p.m. ET to report financial results for second quarter 2024 and provide an update on its business and pipeline. To acce ...

Exhibit 99.1 Spero Therapeutics Announces First Quarter 2024 Operating Results and Provides a Business Update CAMBRIDGE, Mass., May 15, 2024 — 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 ac ...

Revenue Growth - For the three months ended March 31, 2024, total revenues increased to $9.267 million from $2.069 million in the same period of 2023, representing a growth of 348%[179] - Grant revenue for the three months ended March 31, 2024, was $5.063 million, up from $1.329 million in 2023, with a significant increase of $4.436 million attributed to the BARDA contract for tebipenem HBr[181] - Collaboration revenue related to GSK was $4.064 million for the three months ended March 31, 2024, compared to $0.517 million in 2023, marking an increase of $3.547 million[182] Expenses and Losses - Research and development expenses rose to $17.332 million in Q1 2024 from $8.979 million in Q1 2023, an increase of $8.353 million[179] - The net loss for the three months ended March 31, 2024, was $12.669 million, a slight improvement from a net loss of $13.266 million in the same period of 2023[179] - Total research and development expenses for the three months ended March 31, 2024, were $17.3 million, an increase of $8.4 million (93.3%) compared to $9.0 million in the same period of 2023[183] - Direct costs for the SPR720 program increased by $2.6 million (149.9%) to $4.4 million in Q1 2024, driven by increased clinical activity[183] - Direct costs for the tebipenem HBr program rose by $6.1 million (358.4%) to $7.8 million in Q1 2024, due to ongoing Phase 3 trial activities[184] - Personnel-related costs in general and administrative expenses decreased by $1.2 million (26.4%) to $3.3 million in Q1 2024, primarily due to reduced headcount costs[188] Cash Position and Funding - As of March 31, 2024, the accumulated deficit stood at $403.7 million, with cash and cash equivalents of $82.3 million[160] - The company expects its cash runway to last into late 2025, focusing on advancing SPR720 and tebipenem HBr clinical trials[161] - Cash and cash equivalents as of March 31, 2024, were $82.3 million, sufficient to fund operations for at least 12 months[191] - Net cash provided by operating activities for Q1 2024 was $5.9 million, a significant improvement compared to a net cash used of $12.9 million in Q1 2023[194] - Significant additional funding will be required to support ongoing operations and growth strategy, with potential sources including equity offerings and collaborations[163] - The company expects to require additional funding beyond late 2025 to support ongoing operations and clinical trials[201] Product Development and Regulatory Status - The company has not generated any revenue from product sales to date and relies on grant and collaboration revenues for funding[165] - The company has not yet commercialized any product candidates and relies on funding from government contracts and collaboration agreements[191] - The company plans to prioritize advancing SPR720 to key Phase 2 milestones and Phase 3 activities for tebipenem HBr under the GSK License Agreement[161] - SPR206 received Fast Track designation from the FDA in March 2024 for treating specific bacterial pneumonia[185] - The company filed a new universal shelf registration statement for the sale of up to $300 million in various securities, effective March 22, 2024[192]