Newron Pharmaceuticals S.p.A. / IT0004147952
19.09.2024 - 07:00:06Newron presents H1 2024 results and provides business update
| Newron Pharmaceuticals S.p.A. / Key word(s): Half Year Results 19.09.2024 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement. Milan, Italy, September 19, 2024, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the half year ended June 30, 2024, and provided an update on its business activities. Highlights H1 2024: Evenamide Reported positive final one-year results from study 014/015, a Phase II open label trial evaluating evenamide as an add-on therapy to a single antipsychotic in patients with treatment-resistant schizophrenia (TRS): The study demonstrated significant, clinically important, progressive, sustained, and long-lasting improvement on Positive and Negative Syndrome Scale (PANSS) Total, Clinical Global Impression of Severity (CGI-S), the mean rating of change for the Clinical Global Impression of Change (CGI-C) and Level of Functioning (LOF) More than 70% of patients experienced a clinically important reduction in disease severity 25% of all patients achieved “remission,” never described before in TRS patients Reported compelling results from study 008A, a potentially pivotal, four-week randomized, double-blind and placebo-controlled study of evenamide as an add-on therapy in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic: Study analysis revealed statistically significant multi-domain benefits in PANSS and Clinical Global Impression of Change (CGI-C) ratings Benefit on efficacy measures increased over time, suggesting larger and enduring patient effects to be expected during long-term treatment Together, these studies: Confirm evenamide’s favorable safety and tolerability profile Demonstrate evenamide’s efficacy on multiple measures of psychopathology in TRS and chronic schizophrenia Add to the growing evidence that the glutamatergic inhibition mechanism of action offers an innovative therapeutic option to schizophrenia patients not benefitting from current antipsychotic treatments Company is working towards the initiation of a potentially pivotal, multinational, randomized, double-blind, one-year, placebo-controlled study, assessing the efficacy, safety, and tolerability of evenamide as an add-on treatment in patients with TRS Company is currently running a structured process of securing the most attractive, value creating transaction around evenamide, and several indications of interest have been received. Board and Management are prioritizing and negotiating offers according to their potential to increase shareholder value, with the expectation of closing a transaction in the coming months Corporate Company entered into an agreement for the subscription of up to 2.05 million newly issued shares, up to a value of EUR 15 million, with an institutional investor focused on investing in high-growth firms across sectors including biotech and healthcare An agreement was entered into with the European Investment Bank to extend the near-term tranche repayment dates of its 2018 financing agreement until the end of 2025 and into 2026, after potentially significant milestones Chairman and CEO increased their holdings in Newron, underlining their commitment to the Company Stefan Weber, CEO of Newron, commented: “It has been a busy and exciting six months for Newron where we have delivered two positive clinical milestones in the development of our novel drug evenamide. We reported exceptional data demonstrating positive clinical results from both study 014/15 and study 008A, which evaluated evenamide as an add-on treatment for patients with treatment-resistant schizophrenia (TRS) and chronic schizophrenia, respectively. We were also delighted to host a successful Investor Day in June in New York City, featuring presentations from leading KOLs on the unmet medical needs for patients with schizophrenia, underscoring the potentially pivotal role of evenamide for these patients. We believe our new chemical entity has blockbuster potential and could bring enormous benefits to patients who are insufficiently served by the existing treatments available. Newron, with the help of a leading healthcare investment bank, is currently exploring potential partnership agreements and opportunities for collaboration that will enable us to progress evenamide into Phase III clinical development for the potential treatment of patients with TRS and create value for our shareholders.” Evenamide (Schizophrenia) During Q1 2024, Newron reported final one-year results from study 014/015, a Phase II open label trial evaluating evenamide as an add-on therapy to a single antipsychotic in treatment-resistant patients. The data demonstrated that evenamide as an add-on treatment for patients with TRS was associated with sustained, clinically significant benefits that increased throughout the one-year course of treatment, with more than 70% of patients experiencing a clinically important reduction in disease severity. Overall, data from study 014 has demonstrated that evenamide was safe and well-tolerated at all doses, with 97% of patients completing six weeks of treatment. The incidence of treatment-emergent adverse events was very low, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015). In Q2, the Company announced two sets of data from study 008A, a potentially pivotal four-week randomized, double-blind and placebo-controlled study of evenamide as an add-on therapy in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic. Topline data announced in April confirmed evenamide’s favorable safety and tolerability profile, followed by compelling data from additional analyses reported in May. The study met the primary endpoint (improvement of the Positive and Negative Syndrome Scale (PANSS) Total Score) and key secondary endpoint (improvement of the Clinical Global Impression of Severity (CGI-S)), with a high rate of study completion (96%). No new or specific concerns were raised in the study; only 25% of the patients in the study experienced at least one adverse event (evenamide 25% versus placebo 25.8%). Newron will be presenting the results of study 008A at the upcoming 37th ECNP Congress (September 21-24, 2024) in Milan, Italy. The totality of these results validated evenamide as the first glutamate modulator to demonstrate efficacy in inadequately responding patients with schizophrenia in a placebo-controlled study. Following results from both study 008A and study 014/015, Newron’s key focus is now on initiating a Phase III randomized, double-blind, one-year clinical trial. The trial is expected to start in the first half of 2025 and will compare evenamide to placebo as an add-on treatment in at least 400 patients with TRS. Participants will be evaluated at three timepoints, 12 weeks, 26 weeks, and one year, to assess the long-term safety, tolerability, and efficacy of evenamide. The study design has received regulatory approval in all relevant territories, final discussion is ongoing with the US Food and Drug Administration (FDA) on the dosing regimen. Several indications of interest were received in a structured process of securing the most attractive, value creating transaction for Newron’s shareholders, be it a regional or global license or an M&A transaction; with the process supported by one of the world's leading full-service investment banking and capital markets firms. The Board and Management will prioritize and negotiate the offers according to their potential to increase shareholder value, with the expectation to close a transaction in the coming months, enabling progression of the Phase III clinical development of evenamide in TRS patients. Xadago®/safinamide (Parkinson’s disease) In partnership with Zambon and Supernus, Newron continues to further develop and market its product, Xadago®/safinamide. In reference to the receipt of several Paragraph IV Notice Letters in May 2021 regarding the submission by some generic manufacturers of an Abbreviated New Drug Application ANDA to the US FDA, seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the US before expiration of the three US patents listed in the FDA Orange Book for Xadago®, Newron and its partners Zambon and Supernus have reached settlement agreements with said generic manufacturers, thus resolving the legal action. All three patents remain valid and in force. Under the agreement, the generic manufacturers will be allowed to enter the US market with a safinamide mesylate drug product no earlier than December 1, 2027. In the EU, Supplementary Protection Certificates (SPCs) have already been approved in most territories of relevance; Newron and Zambon are confident that upon completion of the still ongoing procedures and targeted activities, the SPCs will be granted in all key territories. Corporate In April, Margarita Chavez, US-based, was elected as a Non-Executive Director to the Board of Newron following the 2024 Annual General Meeting. Margarita Chavez has been an advisor to Newron’s Board since October 2023, and the Company continues to benefit from her more than 20 years of strategic transaction expertise in the US and internationally and her leadership in the pharmaceutical industry. She is heading the Business Development Committee of Newron’s Board of Directors. During the first half of 2024, Newron announced an agreement with the European Investment Bank to extend the near-term tranche repayment dates of the 2018 financing agreement until the end of 2025 and into 2026, after potentially significant milestones. Furthermore, the Company entered into an agreement for the subscription of up to 2.05 million newly issued shares with an institutional investor focused on investing in high-growth firms across sectors including biotech and healthcare. Under the agreement, the fund subscribed to an initial 750,000 newly issued shares at a subscription price of EUR 7.33 per share, which corresponds to gross proceeds of approximately EUR 5.5 million and had the right to subscribe to an additional up to 1,300,000 newly issued shares until no later than January 31, 2025. The funds raised enable Newron to focus its attention on progressing evenamide into Phase III clinical development in TRS patients and support activities beyond immediate inflection points. At the time of this report, 1,350,000 newly issued shares have been subscribed to by the investor, under the rules of the agreement, generating proceeds of EUR 9.9 million. For further detail, please refer to https://www.ser-ag.com/en/resources/notifications-market-participants/significant-shareholders.html#/. In June 2024, Dr. Ulrich Köstlin, Chairman of Newron’s Board of Directors, and Stefan Weber, CEO demonstrated their commitment to Newron and its future by buying shares via the SIX Swiss Exchange and Xetra. ESG commitment and reporting The Company has worked diligently to further implement its Environment, Social and Governance (ESG) strategy and reporting framework as disclosed in the Annual Report 2023. The ESG goals and projects for 2024 are well on track and management hopes that this will ensure Newron operates as a sustainable and conscious employer, business, and provider of innovative therapeutics. The Company will provide a further update in our 2024 Annual Report. Financial Summary (IFRS) H1 2024 and H1 2023 In thousand EUR (except per share information)
19.09.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.eqs-news.com |
| Language: | English |
| Company: | Newron Pharmaceuticals S.p.A. |
| via Antonio Meucci 3 | |
| 20091 Bresso | |
| Italy | |
| Phone: | +39 02 610 3461 |
| Fax: | +39 02 610 34654 |
| E-mail: | pr@newron.com |
| Internet: | www.newron.com |
| ISIN: | IT0004147952 |
| WKN: | A0LF18 |
| Listed: | Regulated Unofficial Market in Dusseldorf (Primärmarkt); SIX |
| EQS News ID: | 1990777 |
| End of News | EQS News Service |
| |
