Genenta Science(GNTA)
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Genenta Reports Long-Term Survival Trends and Immune Findings in Brain Tumor (GBM) Trial
Globenewswire· 2025-11-24 09:00
Core Insights - Genenta Science has provided an update on its TEM-GBM study for newly diagnosed glioblastoma multiforme (GBM) patients with an unmethylated MGMT gene promoter, reporting that 25 patients have been treated with Temferon as of November 21, 2025 [1][2] Group 1: Clinical Study Results - Key survival metrics for TEM-GBM patients show that 44% of patients have reached 18-month survival, an increase from 38% reported in April 2025 [7] - The two-year survival rate remains at 29%, and the median overall survival is consistent at 17 months, compared to historical cohorts of uMGMT patients treated with standard care, which typically show a two-year survival rate of approximately 14% and median overall survival of 13-15 months [7] - The study includes a patient who has reached three years of survival following Temferon administration, marking a significant milestone in the study [7] Group 2: Mechanism and Observations - The GBM study provides early observations on Temferon's behavior within the tumor microenvironment, indicating that bone-marrow-derived myeloid cells can deliver immunotherapeutic payloads at the tumor site, aligning with the platform's intended design [3] - These preliminary findings are exploratory and will inform the broader development of Temferon, including potential combination approaches and the evolution of the underlying cell-based delivery technology [3] Group 3: Financial Position - Following a registered direct offering on October 27, the company reported approximately $30 million in cash and short-term investments as of November 1, 2025 [4] Group 4: Company Overview - Genenta Science is a clinical-stage immuno-oncology company developing a proprietary hematopoietic stem cell therapy for various solid tumor cancers, with Temferon as its first-in-class product candidate [5] - The company has completed a Phase 1 trial for newly diagnosed GBM patients with an unmethylated MGMT gene promoter, suggesting potential reprogramming of the tumor microenvironment and induction of T cell responses [5] - Genenta has also initiated a Phase 1/2a study for metastatic Renal Cell Carcinoma, which will include combinations with immune checkpoint inhibitors [5]
GNTA, BBIO, AMRN Jump After Hours: Key Biotech Catalysts Driving Stock Gains
RTTNews· 2025-10-29 05:03
Core Insights - Several biotech and healthcare stocks experienced significant after-hours trading gains due to clinical updates, strategic deals, and regulatory milestones [1] Company Summaries - **Genenta Science S.p.A. (GNTA)**: Shares closed at $2.40, down 27.71% during regular trading, but rebounded to $2.45, up 2.08% in after-hours. The volatility was driven by a $15 million registered direct offering and a strategic collaboration announcement [2] - **EDAP TMS S.A. (EDAP)**: Closed at $1.81, down 22.58%, but rose 8.29% to $1.96 in after-hours trading. The recovery appears technical, with no new news, and is supported by upcoming investor meetings at the UBS Global Healthcare Conference [3] - **BridgeBio Pharma Inc. (BBIO)**: Ended regular trading at $64.50, up 1.48%, and climbed 6.71% to $68.83 after hours. The increase reflects anticipation for Phase 3 CALIBRATE trial results for ADH1, with topline data expected on October 29 [4] - **OrthoPediatrics Corp. (KIDS)**: Closed at $16.91, down 0.29%, but surged 6.45% to $18.00 after releasing Q3 financial results, reporting a GAAP loss per share of $(0.50) despite 12% revenue growth [5][6] - The company raised its full-year 2025 revenue guidance to $233.5 million to $234.5 million, indicating projected growth of 14% to 15% compared to the prior year [7] - **Modular Medical Inc. (MODD)**: Dipped 1.30% to $0.5392 but rallied 5.38% to $0.5682 after hours following the successful completion of its Stage 1 ISO 13485:2016 audit, a key step toward CE Mark certification [8] - **Vivani Medical Inc. (VANI)**: Rose 3.09% to $1.67 and added 3.65% to $1.7310 after closing a $15.7 million capital raise, which included a registered direct offering and private placement, indicating insider confidence [9] - **Amarin Corp. plc (AMRN)**: Slipped 1.56% to $18.94 but rebounded 5.07% to $19.90 after the FDA revised fenofibrate drug labeling, which may favor Amarin's Vascepa in the lipid management space [10]
Genenta: Lentiviral Vector Technology Early Survival GBM Signal Warrants Buy Rating
Seeking Alpha· 2025-10-27 21:31
Core Viewpoint - Genenta Science (NASDAQ: GNTA) has received a "Buy" rating following a significant stock increase of 90% on Friday due to positive news [2]. Company Overview - Genenta Science is a pharmaceutical company that has recently gained attention in the biotech sector [2]. - The company is part of a broader analysis service that includes a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2]. Market Context - The stock market reaction indicates strong investor interest and confidence in Genenta Science, reflecting potential growth opportunities in the biotech industry [2].
Basic-Fit N.V. (BSFFF) M&A Call Transcript
Seeking Alpha· 2025-10-27 21:27
Group 1 - The core announcement is that Basic-Fit is in the process of acquiring Clever Fit, which is recognized as Europe's largest fitness franchise [1][2] - The call includes insights from key executives, including the CEO and CFO, who will discuss synergies, transaction details, financing, and updated market guidance [2] Group 2 - The CEO will provide an explanation of the synergies expected from the merger between Basic-Fit and Clever Fit [2] - The CFO will outline the financing structure of the acquisition and offer updated guidance to the market [2]
Genenta Announces Pricing of $15.0 Million Registered Direct Offering of American Depositary Shares
Globenewswire· 2025-10-27 00:30
Core Viewpoint - Genenta Science has entered into a securities purchase agreement to sell 4,285,715 American Depositary Shares (ADSs) at $3.50 per ADS, aiming for gross proceeds of approximately $15.0 million before expenses [1][2]. Group 1: Offering Details - The offering involves the sale of securities solely by Genenta, with no warrants or derivative securities issued [1]. - Maxim Group LLC is the lead placement agent, while Rodman & Renshaw LLC acts as the co-placement agent for the offering [2]. - The expected closing date for the offering is around October 28, 2025, pending customary closing conditions [2]. Group 2: Use of Proceeds - Genenta plans to utilize the net proceeds from the offering for working capital and general corporate purposes [2]. Group 3: Company Overview - Genenta Science is a clinical-stage immuno-oncology company focused on developing proprietary hematopoietic stem cell therapies for solid tumor cancers [5]. - The company's lead product candidate, Temferon™, aims to express immune-therapeutic payloads within the tumor microenvironment, potentially enhancing immune responses [5]. - Genenta has completed a Phase 1 trial for newly diagnosed Glioblastoma Multiforme (GBM) patients and has initiated a Phase 1/2a study for metastatic Renal Cell Carcinoma, which will include combinations with immune checkpoint inhibitors [5].
Latest Market Movements: Top Gainers Analysis
Financial Modeling Prep· 2025-10-24 22:00
Company Highlights - Wellgistics Health, Inc. (NASDAQ:WGRX) experienced a significant price increase of 168.16%, reaching $1.08, driven by its blockchain initiative in prescription drug tracking [1][5] - MaxsMaking Inc. (NASDAQ:MAMK) saw its stock price rise by 148.70% to $7.43, following a successful IPO that raised $6.5 million, indicating strong investor interest in its innovative textile production [1][5] - Inhibrx Biosciences, Inc. (NASDAQ:INBX) reported a stock price surge of 94.43% to $55.13, likely due to positive developments in its clinical trials for a rare bone cancer treatment [2][5] - Genenta Science S.p.A. (NASDAQ:GNTA) experienced a 92.72% increase in stock price to $6.22, attributed to promising clinical trial results and a strategic partnership with ANEMOCYTE [3] Market Dynamics - The significant price movements across these companies reflect diverse investor interest in sectors such as healthcare, biotechnology, and consumer goods, influenced by clinical trial outcomes, strategic partnerships, and innovative product offerings [4]
Genenta and Anemocyte Announce Strategic Partnership to Advance Off-The-Shelf LVV Plasmid DNA Production
Globenewswire· 2025-10-24 08:00
Core Insights - Genenta Science and ANEMOCYTE have announced a strategic collaboration focusing on off-the-shelf lentiviral vector (LVV) Plasmid DNA technology, expanding their existing partnership in plasmid DNA production [1][2][3] - The collaboration aims to enhance ANEMOCYTE's offerings by utilizing Genenta's established LVV Plasmid DNA technology, which is based on foundational research by Professor Luigi Naldini [2][3] - This partnership is expected to support the development of advanced therapy programs across the life sciences industry, ensuring clients have access to reliable and scalable solutions [3] Company Overview - Genenta Science is a clinical-stage immuno-oncology company developing a proprietary hematopoietic stem cell therapy for solid tumor cancers, with its lead product candidate being Temferon™ [5] - Temferon™ is designed to express immune-therapeutic payloads within the tumor microenvironment, potentially enhancing T cell responses and breaking immune tolerance [5] - ANEMOCYTE is a Biotech Manufacturing Organization based in Italy, specializing in the development and manufacturing of pDNA and mRNA, with over 25 years of expertise in innovative therapies [4]
Genenta and Anemocyte Announce Strategic Partnership to Advance Off-The-Shelf LVV Plasmid DNA Production
Globenewswire· 2025-10-24 08:00
Core Insights - Genenta Science and ANEMOCYTE have announced a strategic collaboration focusing on off-the-shelf lentiviral vector (LVV) Plasmid DNA technology, expanding their existing partnership in plasmid DNA production [1][3] - The collaboration aims to leverage Genenta's established LVV Plasmid DNA technology, enhancing ANEMOCYTE's offerings to clients by providing high-quality materials from R&D to GMP grade [2][3] - This partnership signifies a commitment to supporting the life science industry with innovative solutions, ensuring clients have access to a reliable platform for advanced therapy programs [3] Company Profiles - Genenta Science is a clinical-stage immuno-oncology company developing a proprietary hematopoietic stem cell therapy for various solid tumor cancers, with its first-in-class product candidate, Temferon™, designed to express immune-therapeutic payloads within the tumor microenvironment [5] - ANEMOCYTE is a Biotech Manufacturing Organization based in Italy, specializing in the development and manufacturing of pDNA and mRNA, with over 25 years of expertise in innovative therapies [4]
Genenta Announces Long-Term Follow-Up Observations in Brain Tumor (GBM) Study with Emerging Survival Signals
Globenewswire· 2025-07-01 09:00
Core Insights - Genenta Science is conducting ongoing clinical trials for its immuno-oncology product, Temferon, focusing on glioblastoma multiforme and genitourinary tumors [1][3][6] Group 1: Glioblastoma Multiforme Study - A total of 38 patients have been enrolled in the glioblastoma multiforme study, with 25 patients receiving Temferon [1] - The two-year survival rate for unmethylated MGMT (uMGMT) patients in the GBM trial is 29%, with a median overall survival of 17 months, compared to historical cohorts showing a 14% survival rate and a median overall survival of 13 to 15 months [2] - Two patients have been enrolled in a long-term follow-up study, with one showing no disease progression and the other stabilizing after initial progression, indicating potential efficacy of Temferon [1] Group 2: Genitourinary Tumor Study - The TEM-GU Phase 1 study has begun recruitment, aiming to enroll 12 patients with genitourinary tumors, administering Temferon at a fixed dose of 4 million genetically modified cells per kilogram [3] - The study will evaluate the safety and tolerability of Temferon in combination with immune checkpoint inhibitors or tyrosine kinase inhibitors [3] Group 3: Mechanism of Action - Temferon works by reprogramming the tumor microenvironment to enhance adaptive immune responses [4] - A scientific manuscript has been accepted for publication, demonstrating Temferon's potential to enhance CAR-T activity in preclinical models [4][5] Group 4: Company Overview - Genenta Science is a clinical-stage immuno-oncology company developing hematopoietic stem cell therapy for solid tumors, with Temferon as its first product candidate [6] - The company has completed a Phase 1 trial for newly diagnosed GBM patients with an unmethylated MGMT gene promoter, suggesting potential for reprogramming the tumor microenvironment [6]
Genenta and Anemocyte announce a collaboration for the manufacturing of starting materials for cutting-edge cell-based therapies
Globenewswire· 2025-05-07 11:00
Core Insights - Genenta Science has announced a collaboration with Anemocyte to establish Cell Banks and produce Plasmids for viral vector production, marking a significant milestone in immuno-oncology therapies [1][2] Company Overview - Genenta Science is a clinical-stage immuno-oncology company focused on developing hematopoietic stem cell therapy for solid tumor cancers, with its lead product candidate being Temferon™ [5] - Anemocyte is a Biotech Manufacturing Organization based in Italy, specializing in the development and production of pDNA and mRNA, with over 25 years of experience in manufacturing innovative therapies [4] Collaboration Details - The partnership aims to leverage Genenta's innovative platform and Anemocyte's expertise in producing high-quality starting materials, which is crucial for advancing clinical trials [2][3] - Anemocyte's team has played a vital role in the manufacturing process, confirming the quality and reliability of their plasmid DNA for therapeutic products [3] Clinical Development - Genenta has completed a Phase 1 trial for newly diagnosed Glioblastoma Multiforme patients and has initiated a Phase 1/2a study for metastatic Renal Cell Carcinoma, which will include combinations with immune checkpoint inhibitors [5]