Genenta publishes business update for the first half of 2022 and

  • Current data from the dose escalation study show a median overall survival of 17 months
  • Adding a cohort to the Phase 1/2a trial in GBM to evaluate an additional conditioning regimen
  • Cash and cash equivalents of €34.7 million as of June 30, 2022, providing a liquidity reserve until the end of 2024
  • €1.8 million unrealized currency gain

MILAN, Italy and NEW YORK, Oct. 24, 2022 (GLOBE NEWSWIRE) — Genenta Science (Nasdaq: GNTA) (“Genenta” or the “Company”), a clinical-stage immuno-oncology company developing a cell-based platform utilizing the power of hematopoietic stem cells to deliver durable and safer Solid Tumor Treatments, provides business and financial results for the six months ended June 30, 2022.

Pierluigi ParacchiCEO, said, “Genenta made significant clinical progress in the first half of 2022 following the successful completion of our IPO in December 2021, raising gross proceeds of $37.2 million. Genenta presented clinical data from the phase 1/2a dose escalation study of Temferon™ at several prestigious scientific meetings earlier this year (including AACR, ASGCT, ASCO), confirming biological activity consistent with Temferon’s mechanism of action.

We have also strengthened corporate governance with two senior appointments, Mark A. Sirgo, PharmD, as Chairman of the Board and Timothy J. Obara as Vice President of Business Development. We are pleased to welcome Mark and Tim who bring significant and highly relevant expertise to our operations as we continue the exciting development of Genenta and our cell-based technology.”

Carlo Russo, Chief Medical Officer and Head of Development, said, “The data generated to date in our Phase 1/2a study of Temferon provides preliminary evidence for the ability of Temferon’s mechanism of action to reduce the systemic toxicity of the administered antitumor payload (interferon-alpha ) to avoid. its local expression within the tumor microenvironment and the presence of genetically engineered TEMs (TIE2-expressing monocytes) more than 18 months after treatment, suggesting a potentially durable effect. Current data show that the median overall survival is 17 months.

This ongoing study has been expanded to the next planned dose. The study tested escalating doses of Temferon along with different conditioning regimens used as pre-treatment to prepare patients for therapy. We are adding an additional cohort to evaluate an additional conditioning regimen aimed at further maximizing effective engraftment, reducing the risk of severe immunosuppression, and facilitating the expansion of our hematopoietic technology platform to a variety of solid cancer indications as a single therapy or combination Product. We expect to complete enrollment and dosing of patients in the second half of 2023.”

business update

  • The ongoing phase 1/2a study of Temferon in glioblastoma multiforme patients with an unmethylated MGMT gene promoter (uMGMT-GBM) has been extended to the next planned dose. Because no drug-limiting toxicities were observed at lower doses, Genenta has now administered a dose of 3.0 x 10 to patients in a new cohort (Cohort 6).6 Temferon cells per kilogram, 50% higher than previous cohort.
  • Preliminary results from the phase 1/2a study of Temferon in the treatment of patients with glioblastoma multiforme provided early evidence of its potential to modulate the tumor microenvironment and signs of biological activity. The results also demonstrated good tolerability and the lack of systemic toxicity of Temferon. The results were presented as an oral presentation at the 25thth Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT).
  • The company presented clinical data from the Phase 1/2a dose escalation study of Temferon at the American Association for Cancer Research (AACR) and American Society of Clinical Oncology (ASCO) Annual Meetings. Data from 15 treated patients provided preliminary evidence of successful engraftment of Temferon-derived cells and evidence of biological activity in tumors occurring in patients with uMGMT-GBM who undergo 2ndnd Surgery.
  • The Company named Mark A. Sirgo, PharmD, an executive with over 35 years of pharmaceutical industry experience, as its new Chairman of the Board. dr Sirgo founded and served as CEO of specialty pharmaceutical company Biodelivery Sciences, Inc. (Nasdaq:BDSI) for 13 years before it was sold to Collegium in April this year.
  • The Company also appointed Tim Obara, a highly experienced commercial healthcare executive with significant experience across a broad spectrum of therapeutic areas and global responsibility, as Vice President, Business Development. He came from the University of Pennsylvania’s Gene Therapy Program, where he was Executive Director of Research Operations.

Financial results for the six months ended June 30, 2022

For the six months ended June 30, 2022 and June 30, 2021, the Company reported a net loss of €2.1 million and €4.0 million and a net loss per share of €0.12 and 0, respectively. €27 per share. The decrease in net loss for the six months ended June 30, 2022 compared to the same period in 2021 resulted primarily from: i) an unrealized foreign exchange gain of €1.8 million due to a strong US Dollar and a weak Euro as the Most of the proceeds from the Company’s December 2021 IPO were generated in US Dollars, although the Company reports in Euros and the vast majority of the Company’s expenses are in Euros. On December 17, 2021 (the date of the Company’s IPO), the Euro-USD exchange rate was 1.133; and on June 30, 2022, the exchange rate was 1.039; ii) a decrease in research and development expenses of EUR 1.6 million, due in part to changes in patient treatment planning in the Company’s Phase 1/2a clinical trial, changes in the combination of therapy treatments that patients in the study were undergoing were manufacturing and the greater offsetting benefit accruing from the Italian Tax Agency’s tax credit for research and development costs; and iii) an increase in general and administrative expenses of €1.7 million due to an expansion of the Company’s infrastructure to manage its operations, primarily related to compliance, administration and corporate governance.

There were no sales for the six months ended June 30, 2022 or June 30, 2021. Research and development expenses were €1.6 million and €3.2 million for the six months ended June 30, 2022 and June 30, 2021, respectively. General and administrative expenses for the six months ended June 30, 2022 and June 30, 2021 were €2.5 million and €0.8 million, respectively. The unrealized foreign exchange gain was €1.8 million and €0 for the six months ended June 30, 2022 and June 30, 2021, respectively.

As of June 30, 2022, the Company had €34.7 million in cash and cash equivalents compared to €37.2 million in cash and cash equivalents as of December 31, 2021. The Company anticipates that these funds will be sufficient to fund the Operation to be funded by the end of 2024.

About Genenta Science

Genenta (www.genenta.com) is a clinical-stage immuno-oncology company developing a cell-based platform that harnesses the power of hematopoietic stem cells to provide durable and safe treatments for solid tumors. Our platform is not limited by tumor type or target antigen and should enable sustained targeted expression of therapeutic payloads within the tumor microenvironment. Genenta’s lead product candidate, Temferon, aims to target interferon-alpha to the tumor microenvironment, minimizing systemic toxicity while disrupting tumor-induced immune tolerance. Our treatments are designed as one-off monotherapies, but have the additional potential to significantly increase the effectiveness of other approved therapeutics when combined.

Forward-Looking Statements

Statements in this press release contain “forward-looking statements” within the meaning of the US Private Securities Litigation Reform Act of 1995 that involve significant risks and uncertainties. All statements in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements contained in this press release can be identified by the use of words such as “anticipate”, “believe”, “consider”, “could”, “estimate”, “expect”, “intend”, “aim”, “may”, “could”. ‘, ‘plan’, ‘potential’, ‘predict’, ‘project’, ‘suggest’, ‘aim’, ‘aim’, ‘should’, ‘will’, ‘would’ or the negative of these words or other similar expressions , although not all forward-looking statements contain those words. Forward-looking statements are based on Genenta’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks associated therewith at the completion and timing of the Phase 1/2a clinical trial or any studies related to the treatment of patients with glioblastoma multiforme who have an unmethylated MGMT gene promoter (uMGMT-GBM) future events that may not prove correct Di These and other risks and uncertainties are described in full in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of the date of this press release and the Company undertakes no obligation to update such information, except as required by applicable law.

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