Moleculin Reports Second Quarter 2025 Financial Results and Highlights
Globenewswire· 2025-08-13 12:05
Core Insights - Moleculin Biotech, Inc. is making significant progress in its Phase 2B/3 MIRACLE trial for Annamycin, targeting relapsed or refractory acute myeloid leukemia (AML) with an expected data readout before the end of 2025 [1][2][21] Clinical Development Updates - The MIRACLE trial is expanding with over 20 additional clinical sites expected to begin recruitment by the end of Q3 2025, including locations in the US, Europe, and the Middle East [1][7] - The trial utilizes an adaptive design, with the first 75 to 90 subjects randomized to receive different doses of Annamycin combined with high-dose cytarabine [6][10] - Preliminary efficacy data is expected to be unblinded for the first 45 subjects treated before the end of 2025, with a second unblinding anticipated in the first half of 2026 [8] Financial Results - For Q2 2025, the company reported a research and development expense of $3.6 million, down from $4.1 million in Q2 2024, primarily due to reduced clinical trial activity [18] - General and administrative expenses remained stable at $2.1 million for both Q2 2025 and Q2 2024 [18] - As of June 30, 2025, the company had cash and cash equivalents of $7.6 million, which is expected to fund operations into Q4 2025 [19] Annamycin Development Milestones - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML and soft tissue sarcoma [15] - Positive topline results from the U.S. Phase 1B/2 trial for Annamycin in treating soft tissue sarcoma lung metastases showed a median overall survival of 13.5 months, compared to 8-12 months for standard treatments [13] Intellectual Property and Strategic Partnerships - The company has bolstered its intellectual property portfolio with a notice of intent to grant a new European patent for Annamycin [7] - An industry veteran has been engaged to explore strategic partnerships related to Annamycin [7]
Worksport Posts Q2 2025 Results: Gross Profit Increases 173%, Revenue Jumps 83%, Margin Expands 870 bps, Operating Loss Improves 15% [QoQ].
Globenewswire· 2025-08-13 12:02
Core Viewpoint - Worksport Ltd. reaffirms its revenue target of at least $20 million for 2025 and highlights a clear path towards achieving operational cash flow positivity in the near term [1][6]. Financial Performance - In Q2 2025, Worksport achieved record net sales of $4.10 million, representing a 114% increase year-over-year and an 83% increase sequentially [2]. - Gross margin improved by 8.7 percentage points to 26.4%, leading to a 173% increase in gross profit to $1.08 million [2]. - Operating loss decreased by 15% quarter-over-quarter to $(3.62) million, while net loss narrowed by approximately 16% to $(3.73) million [2][6]. - Operating cash use improved by 19% to $(3.10) million, with total liquidity at approximately $6.1 million [2][6]. Sales and Dealer Network - The company set three consecutive monthly sales records in Q2, with April at $1.22 million, May at $1.28 million, and June at $1.60 million, leading to an annualized run rate of $19.2 million [3]. - Year-to-date, Worksport has added over 450 new dealer accounts, with a network capable of generating approximately $21.5 million in annual repeatable revenue [3]. Operational Highlights - Q3 2025 output is expected to be significantly stronger than Q2, with July output averaging 115-130 units per day and targeting ~200 units per day by late Q3 [8]. - The innovation pipeline includes the upcoming launches of HD3, SOLIS, and COR products, with SOLIS and COR expected to contribute to revenue in 2026 [8][9]. Management Commentary - CEO Steven Rossi emphasized that the company is executing towards operational cash-flow positivity and preparing for product launches, believing that the tonneau business alone can lead to profitability in 2026 [5]. - CFO Michael Johnston highlighted strong sequential leverage, with expectations for gross margin to approach 30% by year-end and targeting operating cash-flow breakeven by late Q4 2025 or early Q1 2026 [6]. Capital and Liquidity - The company expects to close its current Regulation A offering by the end of August 2025, which, if fully subscribed at $10 million, would provide funding through 2025 and into 2026 [13]. - Outstanding warrants may provide growth capital in 2026, with the company aiming to limit notable equity dilution while pursuing disciplined growth [13].
Mainz Biomed Receives Swiss Regulatory Approval to Market ColoAlert®
Globenewswire· 2025-08-13 12:01
Core Insights - Mainz Biomed has received regulatory approval from Swissmedic for its non-invasive colorectal cancer screening test, ColoAlert, allowing it to be distributed in Switzerland [1][3][4] - The target demographic for colorectal cancer screening in Switzerland includes individuals aged 50 to 74, with an estimated population of 2.8 million in this age group, representing approximately 31.4% of the total population [2] - Current participation rates in existing screening programs are below 50%, indicating a significant opportunity for ColoAlert to enhance participation and support national health objectives [2][4] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, with ColoAlert being its flagship product [5] - The company is expanding its market presence through partnerships with local laboratories and healthcare providers to ensure broad access to its diagnostic solutions [4][5] - In addition to ColoAlert, Mainz Biomed is developing PancAlert, an early-stage pancreatic cancer screening test [5]
Altus Group Responds to Media Reports
Globenewswire· 2025-08-13 11:48
Core Viewpoint - Altus Group Limited is undergoing a strategic review that may involve acquisitions, divestitures, or a potential sale or merger, although no specific actions are guaranteed from this process [2][3]. Group 1 - The company acknowledges recent media speculation regarding a potential transaction but maintains a policy of not commenting on market rumors [1]. - The board of directors is committed to maximizing stakeholder value through the ongoing strategic review [2]. - The review process may not lead to any definitive actions, and the company will only disclose developments as required by regulatory obligations [3]. Group 2 - Altus Group connects data, analytics, applications, and expertise to enhance commercial real estate (CRE) performance, with a global team of approximately 2,000 experts [4].
The Keg Royalties Income Fund announces Successful Closing of the Transaction with Fairfax
Globenewswire· 2025-08-13 11:45
Not for distribution to U.S. News wire services or dissemination in the U.S. VANCOUVER, British Columbia, Aug. 13, 2025 (GLOBE NEWSWIRE) -- The Keg Royalties Income Fund (the “Fund”) (TSX: KEG.UN) and 1543965 B.C. Ltd. (the “Purchaser”), a subsidiary of Fairfax Financial Holdings Limited (collectively with its affiliates, “Fairfax”) are pleased to announce the successful closing of the previously announced plan of arrangement (the “Transaction”) pursuant to which the Purchaser acquired all of the issued and ...
Sagimet Biosciences Reports Second Quarter 2025 Financial Results and Provides Corporate Updates
Globenewswire· 2025-08-13 11:30
Core Insights - Sagimet Biosciences has made significant progress in developing therapeutics for metabolic dysfunction associated steatohepatitis (MASH) and acne, with denifanstat meeting all primary and secondary endpoints in a Phase 3 clinical trial in China [2][5] - The company has initiated a Phase 1 clinical trial for TVB-3567, a new FASN inhibitor for acne treatment in the U.S., and plans to evaluate a combination of denifanstat and resmetirom in a Phase 1 trial in late 2025 [2][11] Recent Corporate Highlights - Denifanstat's Phase 3 trial in China involved 480 patients and demonstrated a treatment success rate of 33.2% compared to 14.6% for placebo, with significant reductions in total lesion count and inflammatory lesions [5] - The Phase 1 trial for TVB-3567 is designed to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants, including those with acne [4][11] Financial Results - As of June 30, 2025, the company reported cash and cash equivalents of $135.5 million, with research and development expenses of $7.2 million for the quarter, up from $6.3 million in the same period in 2024 [11][12] - The net loss for the three months ended June 30, 2025, was $10.4 million, compared to $8.1 million for the same period in 2024 [11][12] Industry Context - Acne affects over 50 million people annually in the U.S., and there has been limited innovation in treatment options over the past 40 years, highlighting the potential market opportunity for new therapies like denifanstat [4][14] - MASH is a progressive liver disease impacting over 115 million people globally, with only one recently approved treatment in the U.S., indicating a significant unmet medical need [13]
Nayax Reports Second Quarter 2025 Results
Globenewswire· 2025-08-13 11:30
Core Insights - Nayax Ltd. reported a revenue of $95.6 million for Q2 2025, reflecting a 22.4% increase from $78.1 million in Q2 2024, driven by both new and existing customer expansion [5][9] - The company achieved a recurring revenue growth of 32%, totaling $70.7 million, which constituted 74% of total revenue [9][12] - Gross margin improved to 48.3%, up from 44.3% in the previous year, attributed to enhanced operational efficiencies and renegotiated contracts [9][10] Financial Performance - Total transaction value increased by 34.3% to nearly $1.6 billion, with the number of processed transactions rising 24.5% to 726 million [7][10] - Adjusted EBITDA for the quarter was $12.6 million, representing a margin of 13% of total revenue, compared to $8.1 million and 10% in the prior year [9][12] - Net income for Q2 2025 was $11.7 million, a significant improvement from a net loss of $3.0 million in the prior year [9][10] Operational Metrics - The customer base grew by 23.5%, adding nearly 5,000 new customers, bringing the total to approximately 105,000 [17] - The dollar-based net retention rate remained high at 123%, indicating strong customer satisfaction [17] - The company managed approximately 1.38 million connected devices, an increase of 16.1% from the previous year [10][17] Strategic Initiatives - Nayax announced a strategic partnership with Autel Energy to integrate its payment technology into 100,000 EV chargers across North America and Europe by the end of 2026 [17] - The company completed the acquisition of Nayax Capital, enhancing its embedded finance solutions [17] - Nayax also acquired Inepro Pay, expanding its reach in the Benelux region and improving operational efficiency [17] Future Outlook - For the full year 2025, Nayax reaffirmed its revenue growth guidance of 30% to 35%, projecting revenue between $410 million and $425 million [12][13] - The company expects at least 50% free cash flow conversion from Adjusted EBITDA for the full year 2025 [13] - Management targets an annual revenue growth of approximately 35% by 2028, with a gross margin of 50% and an adjusted EBITDA margin of 30% [14]
LIXTE Biotechnology Holdings Updates Corporate Treasury Policy to Include Cryptocurrency
Globenewswire· 2025-08-13 11:30
Core Viewpoint - LIXTE Biotechnology Holdings, Inc. has approved a strategic initiative to allocate up to 25% of its treasury to cryptocurrencies, including Bitcoin, reflecting a belief in the long-term potential of digital assets to enhance shareholder value [1][4]. Group 1: Strategic Capital Allocation - The Board of Directors has authorized the allocation of up to 25% of the company's treasury to cryptocurrencies [1]. - The timing and size of cryptocurrency transactions will depend on market conditions and strategic considerations [2]. - The company will hold all cryptocurrency assets with a fully regulated custodian and ensure compliance with financial, legal, and audit regulations [3]. Group 2: Company Overview - LIXTE is a clinical-stage pharmaceutical company focused on developing cancer therapies, with its lead compound, LB-100, showing promise in enhancing chemotherapy and immunotherapy outcomes [4][5]. - The company is engaged in pioneering research in cancer biology, specifically in the area of activation lethality, and has a comprehensive patent portfolio [5]. - Ongoing proof-of-concept clinical trials are being conducted for various cancer types, including Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer [5].
PolyPid Provides Corporate Update and Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-08-13 11:30
Positive Phase 3 SHIELD II Trial Results - D-PLEX₁₀₀ successfully met its primary efficacy endpoint and demonstrated 58% reduction in SSI NDA submission expected in Q1 2026 Unveiled a Long-Acting GLP-1 Receptor Agonists Delivery Platform Targeting the Obesity and Diabetes Market Successful Warrant Exercise Significantly Strengthened Balance Sheet with Cash Runway into 2026 Conference Call Scheduled for Today at 8:30 AM ET PETACH TIKVA, Israel, Aug. 13, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (" ...
Amerigo’s MVC Resumes Fresh Tailings Processing
Globenewswire· 2025-08-13 11:30
Core Viewpoint - Amerigo Resources Ltd. has provided an operational update regarding its Minera Valle Central (MVC) operation, highlighting the resumption of operations at the El Teniente underground copper mine and the processing of fresh tailings [1][2][4]. Group 1: Operational Updates - The El Teniente underground copper mine received approval to restart operations in eight out of twelve sectors, with operations resuming on August 9, 2025 [2]. - Following the restart, MVC began processing fresh tailings from El Teniente on the night of August 10, 2025 [2]. - Prior to the restart, operations at El Teniente were suspended due to a seismic event that resulted in the death of six workers, leading to a temporary halt in the supply of fresh tailings to MVC [3]. Group 2: Production Expectations - Amerigo anticipates that daily throughput from fresh tailings will be lower than initially forecasted in MVC's 2025 production schedule until operations at El Teniente normalize [4]. - The company plans to mitigate production impacts by increasing the processing of historic tailings during this period [5]. Group 3: Company Overview - Amerigo Resources Ltd. is an innovative copper producer with a long-term relationship with Codelco, the world's largest copper producer, and processes both fresh and historic tailings from the El Teniente mine [6].