Tonight, a warning from Florida health officials after four people died and at least 11 others have gotten sick from a rare flesh-eating bacteria found in warm coastal waters. Of the dozens of species of the bacteria, it's vibrio vulonicus that has health officials worried as infections can be severe and life-threatening for some. It can spread from raw seafood, mainly oysters, or through an open wound in direct contact with seawater.Bernie Stewart contracted the bacteria 6 years ago. The charter boat capta ...

Core Insights - Iterum Therapeutics has reported the publication of results from its Phase 3 REASSURE trial, demonstrating the efficacy of oral sulopenem compared to Augmentin for treating uncomplicated urinary tract infections (uUTIs) in women [1][2] - The trial showed that oral sulopenem was statistically superior to Augmentin, with an overall success rate of 61.7% compared to 55.0% for Augmentin [4] - The FDA has approved ORLYNVAH™, Iterum's new drug for treating uUTIs caused by specific resistant pathogens, based on robust data from the REASSURE trial and another pivotal study [5][6] Company Overview - Iterum Therapeutics focuses on developing next-generation antibiotics to combat multi-drug resistant pathogens in both community and hospital settings [1][9] - The company has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications [9] Clinical Trial Details - The REASSURE trial was a non-inferiority study designed to compare oral sulopenem with Augmentin in a population of adult women with uncomplicated uUTIs [2][4] - The trial enrolled 2,222 patients and was conducted under a Special Protocol Assessment (SPA) agreement with the FDA [2] Market Context - UTIs are among the most common bacterial infections, with approximately 15 million emergency room visits and over 40 million prescriptions for uUTIs annually in the U.S. [7] - The increasing rates of multi-drug resistance have made the treatment of uUTIs more challenging, with about 30% of uUTIs caused by quinolone non-susceptible pathogens [7]

Core Insights - TOMI Environmental Solutions, Inc. has been awarded the "Disinfection and Decontamination Products Company of the Year 2025" by MedTech Outlook, showcasing its commitment to excellence and customer trust in its SteraMist iHP technology [1][2][3] Company Overview - TOMI Environmental Solutions, Inc. specializes in disinfection and decontamination solutions, utilizing its proprietary Binary Ionization Technology® (BIT™) platform, which employs a low percentage of hydrogen peroxide as the active ingredient [4] - The SteraMist systems incorporate patented ionized Hydrogen Peroxide (iHP™) technology, providing superior disinfection across various sectors, including healthcare, pharmaceuticals, and food processing [4] Recognition and Commitment - The award selection involved an expert panel of C-level executives and industry leaders, affirming SteraMist's leadership in the disinfection and decontamination market for 2025 [2] - The CEO of TOMI expressed gratitude for the recognition, emphasizing the company's dedication to advancing its iHP technology and exceeding customer expectations globally [3]

Summary of Iterum Therapeutics Conference Call Company Overview - **Company**: Iterum Therapeutics - **Product**: Orlynda (oral solopenem) - **Partnership**: Eversana for commercialization Key Points Industry Context - The uncomplicated urinary tract infection (UTI) market in the U.S. generates approximately **40 million prescriptions annually** [10] - **Two-thirds** of these prescriptions (about **26 million**) are for at-risk patients, including elderly women and those with comorbidities [10] - There have been **no new oral treatments** for uncomplicated UTIs in over **25 years**, with the market leader, nitrofurantoin, approved in **1953** [11] - Rising rates of **antibiotic resistance** are diminishing the effectiveness of existing treatments [12] Product Development and Commercialization - Orlynda received **FDA approval** in **October 2024** and is the only FDA-approved oral penum in the U.S. for uncomplicated UTIs [9] - Iterum has signed a **commercialization agreement** with Eversana to expedite the launch of Orlynda [8] - The expected launch date for Orlynda is by the **fourth quarter of 2025** [3][9] Financial Updates - Pfizer extended the due date for a **$20 million regulatory milestone** payment related to Orlynda from **October 2026** to **October 2029**, alleviating financial pressure [7] - Pricing strategy for Orlynda is not finalized, but expected to be between **$1,400 and $4,700** per treatment course [18] Market Dynamics and Research Insights - Physicians report a **high unmet need** for new antibiotics in the uncomplicated UTI space, with low confidence in existing treatments for at-risk patients [13] - Orlynda is viewed favorably by payers for its efficacy and safety, particularly against multidrug-resistant pathogens [13] Commercialization Strategy - A team of **national account managers** has been trained to ensure optimal market access for Orlynda [14] - The launch will occur in **phases**, with initial focus on territories with high prescription rates [15][16] - Each high-value physician in target territories writes an average of **over 500 prescriptions** for uncomplicated UTIs annually [17] Intellectual Property and Manufacturing - Orlynda has **10 years of marketing exclusivity** in the U.S. from the FDA, expiring in **October 2034** [21] - The company holds multiple patents related to Orlynda, with expiration dates ranging from **2039 to 2041** [24] - Current inventory is projected to last through **mid to late 2026**, with a shelf life of **six years** from manufacture [25] Conclusion - Iterum Therapeutics is making significant progress towards the commercialization of Orlynda, addressing a critical need in the UTI market, and anticipates a successful launch by the end of 2025 [26]

CAMBRIDGE, Mass., May 28, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) and GSK plc (LSE/NYSE: GSK), today announced that the pivotal Phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, met its primary endpoint and will stop early for efficacy (NCT06059846).3 The decision follows a recommendation from an Independent Data Monitoring Committee (IDMC) that completed a pre-specified inte ...

PolyPid (PYPD) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Company Participants Brian Ritchie - Managing DirectorDikla Akselbrad - CEOOri Warshavsky - Chief Operating Officer - USJonny Missulawin - Chief Financial Officer Conference Call Participants Roy Buchanan - Equity Research AnalystChase Knickerbocker - Senior Equity Research Analyst - HealthcareBoobalan Pachaiyappan - Managing Director, Senior Research Analyst Operator and thank you for standing by. Welcome to the Polypede First Quarter twenty twe ...

Core Viewpoint - Spero Therapeutics is focused on advancing its tebipenem HBr clinical program, which aims to provide an oral carbapenem option for complicated urinary tract infections, with an interim analysis of the ongoing Phase 3 PIVOT-PO trial expected in Q2 2025 [2][7][8]. Financial Results - For Q1 2025, Spero reported a net loss of $13.9 million, compared to a net loss of $12.7 million in Q1 2024, resulting in a diluted net loss per share of $0.25 versus $0.24 in the prior year [9][18]. - Total revenue for Q1 2025 was $5.9 million, down from $9.3 million in Q1 2024, primarily due to a decrease in grant revenue, although collaboration revenue increased [9][10]. - Research and development expenses decreased to $13.6 million in Q1 2025 from $17.3 million in Q1 2024, mainly due to lower spending on the SPR720 clinical program [15]. - General and administrative expenses rose to $6.8 million in Q1 2025 from $5.9 million in Q1 2024, attributed to higher personnel-related costs and consulting fees [15]. - As of March 31, 2025, Spero had cash and cash equivalents of $48.9 million, which, along with expected milestone payments from GSK, is projected to fund operations into Q2 2026 [15]. Pipeline Update - Tebipenem HBr is being developed for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), with the goal of reducing inpatient therapy duration [3][8]. - The oral development program for NTM-PD was suspended in Q4 2024 after an interim analysis indicated it did not meet its primary endpoint [8]. Corporate Update - Esther Rajavelu was appointed as President and CEO of Spero effective May 2, 2025, and has been nominated for election to the Board of Directors [5].

TOMI Environmental Solutions (TOMZ) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Rosalyn Christian - Account ManagerHalden Shane - Chairman & CEOElissa Shane - COO & Director Conference Call Participants None - Analyst Operator Greetings. Welcome to the TOMI Environmental Solutions Inc. First Quarter two thousand twenty five Financial Results Conference Call. Please note this conference is being recorded. I will now turn the conference over to your host, Rosalynn Christian from IMS In ...

Financial Data and Key Metrics Changes - Revenue for Q1 2025 increased to $1,577,000, up from $1,114,000 in Q1 2024, representing a 42% increase driven by heightened demand for bit solutions and mobile systems [11] - Product-based revenues totaled $1,000,000 in Q1 2025, reflecting a 35% growth compared to Q1 2024 [11] - Service revenues generated $577,000, a 56% increase from the same prior year period [11] - BIT solution sales reached approximately $300,000, marking nearly a 200% increase from just over $100,000 in Q1 2024 [12] - Operating loss for the quarter was approximately $754,000, an improvement from the operating loss of $1,226,000 in the same quarter last year [12] - Net loss was approximately $256,000 or $0.01 per share compared to $1,310,000 or 7% loss per share in the prior year [12] - Cash and cash equivalents stood at approximately $674,000, with working capital of $3,800,000 [13] Business Line Data and Key Metrics Changes - Total sales in February 2025 saw a 42% increase compared to February 2024, with a 21% increase in April 2025 compared to April 2024 [6] - Year-to-date, there was a 169% surge in bit solution sales compared to the same period last year [6] - The company welcomed several new customers, including a division of the US Army and a children's hospital, indicating expansion in various sectors [8] Market Data and Key Metrics Changes - The company reported an increase in open sales log from approximately $877,000 at the end of 2024 to $1,600,000 by the end of Q1 2025 [10] - The IHP corporate service deployment pipeline currently stands at $1,000,000 in open proposals for 2025 [22] Company Strategy and Development Direction - The company is focused on expanding its product line and distribution strategy, with new service offerings launched in 2024 [5] - There is a commitment to educating the market on the importance of protective disinfection through the SteraMist Pro certified program [7] - The company aims to enhance its sales infrastructure by establishing new distribution channels and recruiting qualified business developers [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about sustaining sales momentum and anticipated a positive trend in sales throughout the year [14] - The company is encouraged by significant progress made in Q1 2025, showcasing the effectiveness of its strategies and product offerings [23] - Management noted that they are not experiencing significant problems due to government budget cuts and expect increased demand from government sectors [28] Other Important Information - The company is actively seeking strong global partners and is focused on rebuilding brand presence in various international markets [21] - The partnership with AlgaFeed has opened a new aquaculture market for SteriMist IHP [8] Q&A Session Summary Question: Do you have any financial goals for the year 2025? - Management is confident that 2025 will be a great year and expects to improve on last year's numbers [25] Question: Do you anticipate any effects from the tariffs trade policy? - Management indicated that they have had minor issues with tariffs but are not experiencing significant problems with international sales [26][27] Question: Do you anticipate significant problems due to government budget cuts? - Management believes there will be an increase in demand from government sectors that utilize their products [28] Question: Any new developments on food safety? - Management reported a surge in interest and requests related to food safety, indicating a growing market [30] Question: Any updates on SteraMist for prevention of bird flu transmission? - Management noted that there is increased interest in using their products for bird flu disinfection, but no significant developments have materialized recently [31][32] Question: Any new developments on Ceramist as an ethylene oxide replacement? - Management confirmed ongoing negotiations with companies looking to replace ethylene oxide with Ceramist [33] Question: Was the order for treating pacemakers used in replacement of ethylene oxide? - The order was not a replacement but helped develop a new protocol for the medical device manufacturer [34][35] Question: Have any new ways been developed to educate the market? - The SteraMist Pro certified program was launched to educate the market and improve product usage [37][38]

Company Overview - TOMI Environmental Solutions, Inc. specializes in disinfection and decontamination solutions, utilizing its proprietary Binary Ionization Technology (BIT) platform [4] - The BIT solution employs a low percentage of hydrogen peroxide as its active ingredient, utilizing patented ionized Hydrogen Peroxide (iHP) technology for superior disinfection [4] - TOMI's products are applicable in various environments, including hospitals, biosafety labs, pharmaceutical facilities, schools, and commercial buildings [4] Financial Reporting - TOMI will report its first-quarter results for the period ending March 31, 2025, after the market closes on May 8, 2025 [1] - A conference call to discuss these results will be held at 4:30 p.m. ET on the same day [1] Participation Information - Participants can join the conference call by dialing (877) 545-0320 or (973) 528-0002 for international callers, using access code 616069 [2] - A replay of the teleconference will be available until May 22, 2025, with access codes provided for both domestic and international callers [3]