This collaboration represents a pivotal step in the advancement of immuno-oncology therapies, highlighting the powerful synergy between Genenta's innovative platform and Anemocyte's proven expertise in the production of high-quality starting materials. Forward-Looking Statements MILAN and NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology and a leader in cell-based therapeutics, today announced a collaboration with Anemocyte, a leading Biotech Manufacturi ...

Core Insights - Genenta Science, a leader in immuno-oncology and cell-based therapeutics, is advancing its pipeline with a strategic financing of €20 million ($22.7 million) through a Mandatory Convertible Bond to ENEA Tech and Biomedical [2] - The company is focused on the development of Temferon™ for metastatic Renal Cell Cancer (mRCC) and has raised an additional €3.0 million ($3.2 million) via an at-the-market facility [2] - CEO Pierluigi Paracchi will present at the "Montalcini Global Biotech Tour" in Doha, Qatar, highlighting the Italian biotech ecosystem and the company's initiatives [1][3] Company Developments - Genenta has completed a Phase 1 trial for newly diagnosed Glioblastoma Multiforme patients, indicating potential for reprogramming the tumor microenvironment [6] - The company has initiated a Phase 1/2a study for metastatic Renal Cell Carcinoma, which will explore combinations with immune checkpoint inhibitors [6] - Temferon™ is designed to express immune-therapeutic payloads within the tumor microenvironment, aiming for a durable and targeted response [6] Strategic Partnerships - The event in Doha will feature key stakeholders, including representatives from the Qatar Investment Authority, which manages over $475 billion in assets, indicating potential for cross-border partnerships [4] - CDP Venture Capital, a long-standing investor in Genenta, participated in the company's IPO on Nasdaq in 2021, showcasing ongoing support from institutional investors [3]

Financial Position - As of December 31, 2024, the company had approximately €12.7 million in cash and cash equivalents and marketable securities[628]. - The company incurred a net loss of approximately €8.9 million for the year ended December 31, 2024, with operating activities using approximately €6.2 million of cash[630]. - The company estimates that existing cash and anticipated cash from short-term financing will be sufficient to fund operations into the second quarter of 2026[642]. - The net cash provided by financing activities for the year ended December 31, 2024, was approximately €270,885 from ATM offerings[629]. - A hypothetical 10% movement in USD to EUR exchange rate would impact the net result by approximately €0.5 million for the year ended December 31, 2024[625]. Revenue Generation - The company has not generated any revenue to date and does not expect to do so in the near term[641]. Investment Activities - Investing activities for the year ended December 31, 2024, used approximately €16.4 million to purchase marketable securities, while proceeds from divestment amounted to approximately €23.2 million[634]. - The company plans to use available cash and marketable securities for potential in-licensing, acquisitions, or investments in additional businesses and technologies[646]. Compensation and Governance - The total compensation paid to all directors and senior management for the year ended December 31, 2024, was approximately €1.3 million[671]. - The total cost to the company for all directors and senior managers for the year ended December 31, 2024, was approximately €2.2 million[673]. - The aggregate compensation received by the Board of Statutory Auditors during 2024 was approximately €44,000[677]. - The company established a Compensation, Nomination and Governance Committee to oversee cash compensation and equity award recommendations for executive officers[681]. - The total salary, bonuses, and related benefits for all directors and senior management amounted to €1,258,468[672]. - The company’s cost for each employee is higher than what is actually paid out due to tax and contribution charges affecting labor costs[674]. Corporate Governance - The company follows the historical Italian corporate governance system with separate boards for directors and statutory auditors[675]. - The company has no arrangements with major shareholders or others regarding the selection of directors or senior management[669]. - The company relies on an exemption from the Rule 10A-3 requirements for foreign private issuers with a board of statutory auditors established in accordance with local law[680]. - The company has opted out of shareholder approval requirements for certain share issuances, differing from Nasdaq Listing Rule 5635[686]. - The company follows a traditional model of corporate governance for Italian companies, exempting it from the audit committee requirements established by Rule 10A-3[686]. - The company is not required to have a majority of independent directors on its board, as per Italian law[684]. - Quorum requirements for general meetings of shareholders are governed by the Italian Civil Code, differing from Nasdaq Listing Rule 5620(c)[684]. Employee Relations - As of March 26, 2025, the company had 13 full-time employees, with 11 located in Milan, Italy, and 2 in the U.S.[687]. - The company considers its relationship with employees to be good[687]. - The company relies on consultants and collaborators at SR-TIGET and OSR for various activities including clinical, research and development, and product development[687]. Audit and Reporting - The board of statutory auditors is responsible for the appointment, retention, and oversight of the work of any registered public accounting firm engaged for audit services[686]. - The management report and annual financial statements must be communicated to the auditor and board of statutory auditors at least 30 days prior to the shareholders' meeting[683].

Core Viewpoint - Genenta Science has secured €20 million ($21.9 million) in financing through a Mandatory Convertible Bond from ENEA Tech and Biomedical (ETB) to advance its pipeline, particularly focusing on Temferon for metastatic Renal Cell Cancer (mRCC) [1][2] Financing Details - The total bond amount is €20 million ($21.9 million), with a maturity of three years and mandatory conversion set for March 2028 [6] - The funding structure includes a first tranche of €7.5 million ($8.2 million) for assessing safety in the ongoing Phase 1/2a trial for mRCC, and a second tranche of €12.5 million ($13.7 million) conditional upon achieving safety and tolerability [6] - ETB's equity in Genenta will be capped at 29%, with a maximum conversion price of $17.64 per share [6] Clinical Developments - The Phase 1/2a trial for mRCC has begun enrolling patients, enhancing Genenta's clinical pipeline for Temferon [3] - Recent data from the Phase 1/2a Glioblastoma Multiforme (GBM) trial indicates a two-year survival rate increase to 29% from 25%, with median overall survival now at 17 months [2][3] - Historical data shows that standard care for uMGMT patients has a two-year survival rate of approximately 14% and median overall survival of 13-15 months [2] Strategic Partnerships - ETB conducted extensive due diligence before the investment, indicating confidence in Genenta's long-term value [2] - The partnership with ETB is expected to provide financial stability necessary for advancing the validation of the Temferon platform and pursuing strategic collaborations [2]

Core Insights - Genenta Science has strengthened its partnership with AGC Biologics by amending their Development and Master Services Agreement, introducing an exclusive GMP suite for the manufacturing of Genenta's cell therapy product [1] - The company is advancing its clinical trials, including a Phase 1/2a trial for metastatic Renal Cell Carcinoma (mRCC) and continuing its study on Glioblastoma Multiforme (GBM), with plans to manufacture 27 autologous drug products in 2025 [2][4] - Genenta's CEO emphasized the commitment to patients and the potential of their product, Temferon, to enhance cancer treatment through reprogramming the tumor microenvironment [3] Company Developments - The exclusive GMP suite at AGC Biologics will ensure compliance with cGMP standards, enhancing production capabilities and efficiency for Genenta's cell therapy products [1] - Genenta's first product candidate, Temferon™, aims to express immune-therapeutic payloads within the tumor microenvironment, potentially breaking immune tolerance and enhancing T-cell responses [4] - The company has completed a Phase 1 trial for newly diagnosed GBM patients and initiated a Phase 1/2a study for mRCC, which may include combinations with immune checkpoint inhibitors [4] Upcoming Engagements - Genenta will participate in the Biotech Showcase 2025 from January 13–15, 2025, in San Francisco to present its technology for treating solid tumors [3] - The CEO will also speak at the "Italy on the Move" event on January 15, 2025, aimed at promoting Italy's life sciences sector and attracting international investments [3]

Core Insights - The event "Italy on the Move" aims to promote investment opportunities in Italy's life sciences sector, which is valued at €270 billion, representing 11% of the country's GDP [1][3] - The Italian life sciences ecosystem is highlighted as a competitive hub for investments in biotech, healthcare, medical devices, and pharmaceuticals, attracting nearly 50 multinational companies [3] - The event will feature discussions on transatlantic partnerships and showcase innovative Italian startups, providing a platform for U.S. healthcare companies and investors to connect with Italian firms [3][4] Investment Opportunities - Italy's life sciences sector is recognized as a significant contributor to the economy, with pharmaceuticals and medical devices being the third largest export category [3] - The event will facilitate partnerships between U.S. and Italian companies, emphasizing Italy's leading position in the EU for pharma CDMO manufacturing value and its global ranking in patents productivity [3][4] - The eighth edition of "Italy on the Move" will include pitch presentations from five key Italian startups, enhancing visibility for innovative SMEs [4] Event Details - The event will take place on January 15, 2025, at INNOVIT in San Francisco, coinciding with the J.P. Morgan Healthcare Conference [1][3] - Keynote speeches will be delivered by prominent figures, including the Ambassador of Italy to the U.S. and the Director General for the Promotion of the Italy System [2][3] - A panel discussion titled "Navigating Transatlantic Partnerships in Life Sciences" will be moderated by a notable industry leader, providing insights into collaboration opportunities [3]

Core Insights - Genenta Science is participating in a significant event focused on biotechnology investments and strategies, highlighting the importance of international collaboration in the sector [1][2] - The CEO of Genenta, Pierluigi Paracchi, emphasizes the need for Italy to leverage its scientific heritage to enhance the application of biotechnologies and attract foreign investments [2][3] Company Overview - Genenta Science is a clinical-stage biotechnology company developing a proprietary hematopoietic stem cell therapy aimed at treating various solid tumor cancers [3] - The company's lead product, Temferon™, utilizes ex-vivo gene transfer into autologous Tie2+ hematopoietic stem/progenitor cells to deliver immunomodulatory molecules directly to tumors [3] Clinical Development - Temferon is currently under investigation in a clinical trial for newly diagnosed Glioblastoma Multiforme patients with an unmethylated MGMT gene promoter [3] - Genenta plans to initiate a Phase 1 clinical trial for metastatic Renal Cell Carcinoma, addressing significant challenges in immuno-oncology such as inducing durable immune responses and avoiding systemic toxicity [3]

Core Insights - Genenta Science has received approval from the Agenzia Italiana del Farmaco (AIFA) for a new Phase 1 clinical trial targeting metastatic Renal Cell Cancer (mRCC), expanding the applications of its product Temferon™ [1][2] - The trial is set to begin in Q4 2024 and aims to address a high-risk patient population with limited treatment options, where the median overall survival is currently less than 2 years [3] Company Overview - Genenta is a clinical-stage biotechnology company focused on developing proprietary hematopoietic stem cell therapies for various solid tumor cancers, with Temferon designed to deliver immunomodulatory molecules directly to tumors [5] - Temferon is currently under investigation for newly diagnosed Glioblastoma Multiforme patients and is expected to commence a Phase 1 clinical trial for mRCC [5] Clinical Progress - The ongoing TEM-GBM development program has completed a Phase 1 dose-ranging trial with 24 patients, showing no dose-limiting toxicities and a median survival of 16.8 months, which is a 25% increase in overall survival over two years [2][3] - Temferon-derived cells were detectable in the peripheral blood for over two years post-infusion, indicating a durable response [2] Preclinical Insights - Recent preclinical studies indicate that Temferon shows synergy with other immunotherapy treatments, enhancing the immune response in solid tumors [4] Upcoming Engagements - Genenta plans to present its developments at the Maxim Group's 2024 Healthcare Virtual Summit from October 15-17 and at the Society for Neuro-Oncology Annual Meeting from November 21-24 in Houston, Texas [4]

Financial Position - As of December 31, 2023, the company had approximately €18.8 million in cash and cash equivalents and marketable securities[582]. - The company incurred a net loss of approximately €11.6 million for the year ended December 31, 2023, with net cash used in operating activities amounting to €11,205,023[584]. - The company estimates that its existing cash will be sufficient to fund operations into the second quarter of 2025[592]. - The net cash provided by financing activities was €531 for the year ended December 31, 2023, with no cash provided in the previous two years[590]. - The company plans to satisfy future cash needs through existing cash and potential additional financings, including a shelf registration statement for up to $100 million[594]. - The company may need to seek additional funds sooner than planned due to various uncertainties, including the impact of the COVID-19 pandemic on operations[593]. Revenue Generation - The company has not generated any revenue to date and does not expect to do so in the near term[591]. Investment Activities - Investing activities for the year ended December 31, 2023, included approximately €5.9 million used to purchase marketable securities[587]. Compensation and Governance - Total compensation paid to all directors and senior management for the year ended December 31, 2023, was approximately €1.3 million[619]. - The total cost to the company for all directors and senior managers for the year ended December 31, 2023, was approximately €2.2 million[621]. - The board of statutory auditors received approximately €44,000 in compensation for their services during 2023[624]. - The company has established a Compensation, Nomination and Governance Committee to oversee cash compensation and equity award recommendations for executive officers[628]. - The total amount paid to directors and senior management includes salary, bonuses, and other related benefits totaling €1,287,772[620]. Corporate Governance - The company relies on home country governance requirements and certain exemptions under Nasdaq rules, as permitted for foreign private issuers[630]. - The company has a board of directors and a separate board of statutory auditors, ensuring compliance with Italian corporate governance practices[623]. - The company has opted out of certain shareholder approval requirements for share issuances, which may differ from Nasdaq Listing Rule 5635[631]. - The company follows the traditional model of corporate governance for Italian companies, relying on a board of statutory auditors instead of an audit committee as required by Nasdaq rules[631]. - The board of directors may include fewer independent directors than required under Nasdaq Listing Rule 5605(b)(1)[631]. - The company does not have a specific regulatory regime for proxy solicitations, differing from Nasdaq Listing Rule 5620(b)[631]. - Quorum requirements for shareholder meetings are governed by Italian law, which may not align with Nasdaq Listing Rule 5620(c)[631]. - The company has established a board of statutory auditors that meets the requirements set forth in Exchange Act Rule 10A-3(c)(3)[632]. Employee Relations - The company maintains a good relationship with its employees, who are engaged in various activities including clinical, research and development, and quality assurance[634]. - As of March 26, 2024, the company had 14 full-time employees, with 11 in Milan, Italy, and 3 in the U.S.[634]. Future Plans - The company plans to propose a loyalty share program at the 2024 shareholders' meeting, which may allow it to elect an exemption from Nasdaq Stock Market Rule 5640 regarding voting rights[633]. Currency Risk - A hypothetical 10% movement in USD to EUR exchange rate would have impacted the company's net result by approximately €0.3 million for the year ended December 31, 2023[580]. - The company has not hedged its foreign currency exchange risk but may consider formal currency hedging transactions in the future[581]. Miscellaneous - The company does not have any actions to recover erroneously awarded compensation[636]. - Dr. Russo has extensive experience in biotech, having held senior roles in various companies and institutions, contributing to the company's R&D efforts[606]. - The company raised over $600 million in capital during Dr. Sirgo's tenure at BioDelivery Sciences, increasing market capitalization from $10 million to nearly $1 billion[609]. - The company has a diverse board with members having extensive experience in pharmaceuticals and finance, enhancing strategic decision-making[609][611][612].

Financial Performance - As of December 31, 2022, the company had approximately €29.8 million in cash and cash equivalents, down from €37.2 million at the end of 2021, reflecting a net decrease of €7.4 million in cash used for operating activities[591][592][603]. - The company reported a net loss of approximately €8.5 million for the year ended December 31, 2022, compared to a net loss of approximately €5.5 million in 2021[593][596]. - Operating activities used approximately €7.4 million of cash and cash equivalents in 2022, with non-cash charges of approximately €0.8 million partially offsetting the net loss[593][594]. - The company did not generate any revenue during the year ended December 31, 2022, and does not expect to generate revenue from product candidates in the near future[603]. - The company estimates that its existing cash will be sufficient to fund operations and capital expenditures through 2024, although this is subject to change based on various factors[604][605]. - Future capital requirements will depend on various factors, including the progress of clinical trials and potential regulatory approvals[606][608]. - The company may seek additional funding sooner than planned if cash needs arise, which could impact research and development efforts[606][607]. Governance and Management - The total compensation for all directors and senior management for the year ended December 31, 2022, amounted to €1,107,965[632]. - The statutory auditors received approximately €44,000 in aggregate compensation for their services during 2022[634]. - The company has a board of directors that follows the historical Italian corporate governance system, separate from the board of statutory auditors[633]. - The company established a Compensation, Nomination and Governance Committee to oversee cash compensation and equity award recommendations for executive officers[639]. - The board of statutory auditors consists of three members, with a term expiring at the shareholders' meeting for the year ending December 31, 2023[636]. - The company relies on home country governance requirements and certain exemptions rather than Nasdaq Stock Market Rules[641]. - The company has opted out of shareholder approval requirements for certain share issuances, differing from Nasdaq Listing Rule 5635[643]. - The company established a board of statutory auditors in accordance with Italian law, which performs functions similar to an audit committee[644]. - The company believes its reliance on Rule 10A-3(c)(3) does not adversely affect the independence of its board of statutory auditors[645]. Human Resources - As of April 19, 2023, the company had nine full-time employees, with six in Milan, Italy, and three in the United States[646]. - The company relies on consultants and a large number of collaborators at SR-TIGET and OSR for various activities[646]. Research and Development - Dr. Russo has extensive experience in biotech, having held senior roles in companies focused on medical affairs and R&D, including GSK and Adverum[620]. - Dr. Naldini, a key scientific advisor, is recognized as a pioneer in lentiviral gene therapy and has authored over 250 scientific publications[626]. - The company has a diverse board with members having extensive experience in pharmaceuticals, finance, and corporate governance[622][624][625]. Investments - Investing activities used €27,070 in 2022 for cybersecurity improvements and ERP system implementation, compared to €9,009 in 2021 for fixed asset investments[598][600]. - The company funded its operations primarily through proceeds from the sale of quotas and its IPO, raising approximately €32.7 million in December 2021[591][600]. - The company has not hedged its foreign currency exchange risk, which may impact its financial results due to fluctuations in exchange rates[590][589].