Genenta Science Spa Stock Price, News & Analysis

Genenta Science (NASDAQ: GNTA) announced its fiscal year 2022 financial results, revealing a net loss of €8.5 million, an increase from €5.5 million in 2021. The loss includes a net exchange rate gain of €2.3 million from USD to EUR conversion. The company reported no revenues for 2022, with R&D expenses rising to €5.3 million and G&A expenses at €5.7 million. Genenta holds a €6.4 million tax credit and €29.8 million in cash, estimated to sustain operations into Q1 2025. CEO Pierluigi Paracchi emphasized progress on their lead technology, Temferon, aimed at treating glioblastoma. The annual report is available on the company's investor relations site.

Genenta Science (NASDAQ: GNTA) has announced an amendment to its license agreement with Ospedale San Raffaele (OSR), now allowing access to all solid tumor indications, pending governmental consent. This expansion is expected to enhance Genenta's intellectual property position and treatment options for various cancers. CEO Pierluigi Paracchi highlighted promising preliminary data from the ongoing glioblastoma study, bolstering the decision for broader access. The amended agreement requires approval from the Italian government, which must respond within 90 days for the changes to take effect.

Genenta Science (NASDAQ: GNTA) announced that the FDA has granted Orphan Drug Designation to Temferon™ for glioblastoma multiforme (GBM) treatment. The designation aims to promote the development of Temferon™, a cell therapy targeting tumor microenvironments with immunomodulatory molecules. This decision is expected to enhance Genenta's clinical program addressing the significant unmet medical need in GBM, where about 60% have unmethylated MGMT promoter status. The ODD provides benefits such as federal grants, tax credits for trials, and a seven-year marketing exclusivity post-approval.

Genenta Science (NASDAQ: GNTA) has announced a development and manufacturing service agreement with AGC Biologics S.p.A. to produce cell therapy lentivirus-based products for its clinical programs. This partnership aims to enhance Genenta's ongoing Phase 1/2 clinical trial, particularly for its treatment targeting glioblastoma multiforme. Following the acquisition of Molecular Medicine's facility by AGC Biologics, the collaboration indicates a strategic expansion, emphasizing the importance of the manufacturing process in clinical progression. CEO Pierluigi Paracchi highlighted expectations for their treatment to significantly impact solid tumors.

Genenta Science (Nasdaq: GNTA) will present data at the Society for Immunotherapy of Cancer's annual meeting, indicating that its product candidate, Temferon, has induced a pro-inflammatory state in glioblastoma patients, potentially inhibiting tumor growth. Preclinical studies suggest that Temferon activates immune responses linked to tumor responses and eradication in certain cases. The CEO highlighted the unmet need in glioblastoma treatment, suggesting Temferon's potential as a disease-modifying intervention. The findings will be presented in Boston from November 8-12, 2022.

Genenta Science (Nasdaq: GNTA) released its financial results for the six months ended June 30, 2022, reporting a net loss of €2.1 million, a reduction from a €4.0 million loss in the same period last year. The company has no revenues but holds €34.7 million in cash, sufficient to fund operations through 2024. Significant progress was made in the Phase 1/2a trial of Temferon for glioblastoma, with a median overall survival of 17 months reported. The trial has escalated to a higher dosing cohort and aims to assess new conditioning regimens for enhanced efficacy.