Spero Therapeutics(SPRO)

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Down 17.7% in 4 Weeks, Here's Why Spero Therapeutics (SPRO) Looks Ripe for a Turnaround
ZACKS· 2025-08-19 14:36
A downtrend has been apparent in Spero Therapeutics, Inc. (SPRO) lately with too much selling pressure. The stock has declined 17.7% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround.We use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock ...
Spero Therapeutics(SPRO) - 2025 Q2 - Earnings Call Transcript
2025-08-12 21:30
Financial Data and Key Metrics Changes - Total revenue for 2025 was $14.2 million, compared to $10.2 million for 2024, indicating a year-over-year increase [16] - R&D expenses for 2025 were $10.7 million, down from $23.7 million in 2024, primarily due to reduced clinical expenses related to the PIVOT PO study [17] - The company reported a net loss of $1.7 million for 2025, significantly improved from a net loss of $17.9 million in 2024, with diluted net loss per share of $0.03 compared to $0.33 for the previous year [18] Business Line Data and Key Metrics Changes - The PIVOT PO trial for tebipenem HBr successfully met its primary endpoint and was stopped early for efficacy, which is expected to lead to cost savings and extend the cash runway into 2028 [6][10] - The positive outcome from the PIVOT PO trial supports the potential of tebipenem HBr as an oral alternative to IV carbapenem therapy for complicated urinary tract infections (CUTIs) [7][8] Market Data and Key Metrics Changes - There are approximately 2.9 million episodes of complicated urinary tract infections annually in the United States, contributing to over $6 billion in healthcare costs [11][12] - The current standard of care for many infections caused by multi-drug resistant (MDR) gram-negative bacteria is IV carbapenem antibiotics, highlighting a significant gap for effective oral alternatives [12][13] Company Strategy and Development Direction - The company aims to ensure that tebipenem HBr reaches the regulatory process and approval, which is seen as a key value driver for future growth [22] - The agreement with GSK allows for potential contingent milestones of up to $351 million, including $25 million upon GSK's submission of the U.S. regulatory filing [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the positive results from the PIVOT PO trial, believing it brings tebipenem HBr closer to becoming the first commercial product from the company's pipeline [18] - The company is currently assessing the next steps for SPR720 after the phase 2A study did not meet its primary endpoint, indicating a cautious approach to future development [14] Other Important Information - The company had cash and cash equivalents of $31.2 million as of June 30, 2025, with additional milestone payments expected to fund operations into 2028 [15] - The trial's early stopping for efficacy has resulted in meaningful cost savings, which is a primary driver for the extended cash runway [10][15] Q&A Session Summary Question: Capital allocation strategy - The company indicated that the primary objective is to ensure tebipenem HBr reaches the regulatory process and approval, with future capital allocation decisions to be made once there is clarity on approval [21][22]
Spero Therapeutics(SPRO) - 2025 Q2 - Quarterly Report
2025-08-12 20:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38266 SPERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 46-4590683 (State or other jurisd ...
Spero Therapeutics(SPRO) - 2025 Q2 - Quarterly Results
2025-08-12 20:17
Exhibit 99.1 Spero Therapeutics Announces Second Quarter 2025 Operating Results and Provides a Business Update CAMBRIDGE, Mass., Aug 12, 2025 — Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. "During the second quarter, we announced that th ...
Spero Therapeutics to Report Second Quarter 2025 Financial Results and Provide Business Update on Tuesday, August 12, 2025
Globenewswire· 2025-08-05 20:05
Core Insights - Spero Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases and multi-drug resistant bacterial infections [1][3] - The company will host a conference call on August 12, 2025, at 4:30 p.m. ET to report its financial results for the second quarter of 2025 and provide a business update [1] Company Information - Spero Therapeutics is headquartered in Cambridge, Massachusetts [3] - The company specializes in addressing high unmet needs in the treatment of rare diseases and multi-drug resistant bacterial infections [3] - For further information, Spero Therapeutics maintains an investor relations page on their corporate website [2][3]
Spero Therapeutics (SPRO) Earnings Call Presentation
2025-07-08 05:53
Tebipenem HBr (cUTI) - Tebipenem HBr is in Phase 3 clinical trials for complicated urinary tract infections (cUTI)[3] - The Phase 3 trial met its primary endpoint following a pre-specified interim analysis (IA) of data from 1,690 enrolled patients[18] - Approximately 2.9 million annual cUTI treatment episodes are attributed to $6+ billion in US healthcare costs[16] - Spero granted GSK an exclusive license for Tebipenem HBr (ex-Asia) and received $66 million upfront and $9 million in common stock investment[32] - Spero is eligible to receive up to $400 million in additional potential regulatory, commercial, and sales milestone payments, as well as royalties from GSK[32] - Spero qualified to receive $95 million in development milestones, with $23.75 million to be received in 2H 2025[33] SPR720 (NTM-PD) - The company has suspended its current development program for SPR720[6, 34] - An interim analysis of a Phase 2a oral study did not show sufficient separation from placebo, highlighting potential oral dose-limiting safety issues in subjects dosed at 1,000 mg orally once daily[37] Financial Foundation - Spero received $30 million upon SPA agreement with the FDA[33] - Spero to receive tiered low-single digit to low-double digit (if sales exceed $1 billion) tiered royalties on net product sales of Tebipenem HBr[33]
Spero Therapeutics -- Additional Upside Potential Following Positive Phase 3 Results
Seeking Alpha· 2025-06-11 19:20
Following the recommendation of the IDMC, Spero Therapeutics (NASDAQ: SPRO ) has decided to stop its PIVOT-PO Phase 3 trial early and ahead of schedule. The study's objective of non-inferiority to intravenous imipenem-cilastatin was achieved , although theHey there, I would like to encourage you to follow me and read my articles for stocks with an excellent risk-reward profile. i am an individual who enjoys dealing with public Biotech companys. I write articles not for investment activities, I just want to ...
Why Is GSK Partner Spero Therapeutics Stock Skyrocketing On Wednesday?
Benzinga· 2025-05-28 15:24
Core Viewpoint - GSK and Spero Therapeutics announced the early termination of the pivotal phase 3 PIVOT-PO trial for tebipenem HBr due to efficacy, leading to a significant increase in Spero's stock price by 245.89% [1] Group 1: Trial Results and Efficacy - The trial demonstrated non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in treating complicated urinary tract infections (cUTIs) [3] - The Independent Data Monitoring Committee (IDMC) found no new safety concerns, with diarrhea and headache being the most reported adverse events [3] Group 2: Market Implications and Regulatory Plans - If approved, tebipenem HBr would be the first oral carbapenem antibiotic for cUTIs in the U.S., enhancing GSK's anti-infectives portfolio and addressing antimicrobial resistance [2][4] - GSK plans to collaborate with U.S. regulatory authorities to submit data for approval in 2025 [4] Group 3: Financial and Healthcare Context - The development of tebipenem HBr is supported by federal funds from various U.S. health departments, highlighting the drug's significance in addressing drug-resistant infections [5] - An estimated 2.9 million cases of cUTIs are treated annually in the U.S., with current treatments primarily requiring intravenous administration [5] Group 4: Previous Developments - This marks GSK's second anti-infective program to be halted early for efficacy in Phase 3, following the gepotidacin trials in 2022 [6] - GSK's Blujepa (gepotidacin) was approved by the FDA for uncomplicated urinary tract infections in March [6] Group 5: Licensing Agreement - In September 2022, GSK entered an exclusive license agreement with Spero Therapeutics for the development and commercialization of tebipenem HBr, excluding certain Asian markets [7]
深夜,暴涨超200%!
证券时报· 2025-05-28 14:26
Group 1: Market Overview - The three major U.S. stock indices opened slightly higher on May 28, with the Dow Jones up 0.05%, S&P 500 up 0.01%, and Nasdaq down 0.03% [1] - Investor focus has shifted from trade war tensions to the latest U.S. tax reform bill, with significant attention on Nvidia's upcoming earnings report [1][10] - Major tech stocks showed mixed performance, with Nvidia down 0.2% ahead of its earnings release [1] Group 2: Trade War Developments - Recent signals indicate a de-escalation in the U.S. trade war, including President Trump's postponement of high tariffs on the EU [5] - The ASEAN leaders expressed concerns over the uncertainty brought by U.S. tariffs and emphasized the need for trade diversification [5] - Current baseline tariffs are at 10%, with potential reductions for countries providing favorable conditions [5] Group 3: Tax Reform Concerns - The latest U.S. tax reform bill is projected to increase the deficit by $3.8 trillion over the next decade, with $2.2 trillion (approximately 58%) occurring in the first five years [8] - Analysts from Deutsche Bank and Morgan Stanley highlight that the deficit will remain above 6% of GDP in the coming years, with the tax reform contributing to this increase [9] Group 4: Nvidia's Earnings Expectations - Nvidia is set to release its earnings report, with analysts expecting revenue of $43.28 billion for the quarter, a year-over-year growth of 66% [11] - The anticipated net profit is around $19 billion, reflecting a 31% increase, although this growth rate is significantly lower than the previous year's 260% [11] - Market attention is on the supply situation of Nvidia's new Blackwell chips and its performance in the Middle East and China [11]
Spero Therapeutics and GSK Announce PIVOT-PO Phase 3 Study for Tebipenem HBr Stopped Early for Efficacy Following Review by Independent Data Monitoring Committee
GlobeNewswire News Room· 2025-05-28 11:00
Core Insights - Spero Therapeutics and GSK announced that the Phase 3 PIVOT-PO trial for tebipenem HBr met its primary endpoint and will stop early for efficacy [1][2][3] Company Overview - Spero Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases and multi-drug resistant bacterial infections [10] - GSK is a global biopharma company aiming to unite science, technology, and talent to combat diseases [9] Trial Details - The PIVOT-PO trial evaluated tebipenem HBr against intravenous imipenem-cilastatin in hospitalized adult patients with complicated urinary tract infections (cUTIs) [6][7] - The trial enrolled 1,690 patients and assessed non-inferiority based on a 10% margin [7] - The primary endpoint was the overall response, which is a composite of clinical cure and microbiological eradication [2][7] Market Potential - An estimated 2.9 million cases of cUTIs are treated annually in the US, contributing to over $6 billion in healthcare costs [3][6] - Tebipenem HBr, if approved, could be the first oral carbapenem antibiotic for US patients with cUTIs [6][7] Future Plans - GSK plans to work with US regulatory authorities to include trial data in a filing expected in the second half of 2025 [2][6] - Full results from the trial will be submitted for presentation at a scientific congress and for publication in a peer-reviewed journal [2]