Newron Pharmaceuticals - Evenamide set for a pivotal year

Newron Pharmaceuticals has reported results for FY23, an active period for its lead asset, evenamide, being developed for treatment-resistant schizophrenia (TRS) and poorly managed schizophrenia (non-TRS). Strong 12-month data were shared in January 2024 from the Phase II trial (study 014/015) in TRS patients, and management is gearing up to launch a potentially pivotal Phase III trial. We expect the next major catalyst to be results of the Phase III trial (study 008A) in non-TRS patients, now a

Newron Pharmaceuticals - Operational flexibility with new/updated financing

Newron Pharmaceuticals has announced new arrangements that offer the company improved operational flexibility. We estimate a pro forma gross cash balance of €17.5m (estimated year-end gross cash of €12m plus €5.5m initial equity issue) to extend the company’s cash runway into FY25, well past the top-line readout from the potentially pivotal 008A study (expected this month) and initiation of the Phase III 003 study (anticipated in Q224), both assessing evanamide in schizophrenia subsets. Provided

Newron Pharmaceuticals - TRS data green-lights evenamide Phase III plans

Newron has announced positive 12-month data from its Phase II extension trial (study 015) assessing evenamide in 161 patients with treatment-resistant schizophrenia (TRS). The results demonstrate desirable safety and tolerability, as well as durable efficacy of evenamide, showing statistically significant improvements (p-value <0.001) in all key efficacy measures (PANSS, CGI-S and LOF) versus baseline. We believe the results are favourable for Newron’s TRS programme and bolster the company’s pla

Newron Pharmaceuticals - Key Evenamide readouts on the horizon

Newron is a Swiss Stock Exchange SIX-listed (NWRN) biopharmaceutical company focused on developing novel medicines for diseases of the central nervous system. The company’s marketed product, Xadago (or safinamide), is an add-on therapy to levodopa for the management of Parkinson’s disease, and continues to drive top-line revenues.

Newron Pharmaceuticals - Positive readout highlights evenamide potential

Newron has announced encouraging interim six-month data from its Phase II trial (study 014/015) of evenamide in 161 patients with treatment-resistant schizophrenia (TRS). The six-month interval data for treatment at all dose levels showed evenamide was well-tolerated and efficacious, with statistically significant responses (p-value <0.001) across the key efficacy measures (PANSS, CGI-S and LOF). The interim data also provide inputs for the potentially pivotal Phase III trial (study 003), which

Newron Pharmaceuticals - Crucial upcoming datasets for evenamide

Newron has released its H123 results and presented an overview of its upcoming clinical activities assessing evenamide as a potential treatment for schizophrenia. Positive results from these trials from Q423 to Q124, may represent the most significant near-term catalysts for the company, in our view. Throughout the period, Newron has also continued to work with partners Zambon and Supernus to maintain the intellectual property of Xadago in the US, which is protected by three patents until at lea

Newron Pharmaceuticals - Encouraging efficacy data from evenamide trial

Newron has presented new efficacy data from its Phase II evenamide trial (study 014/015) at the CINP World Congress of Neuropsychopharmacology and the 2023 Congress of the Schizophrenia International Research Society. These data, from the first 100 patients at the one-year timepoint, indicate significant and clinically important results, with continuous improvements across the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression of Change (CGI-C), Severity of Illness (

Newron Pharmaceuticals - Positive top-line data to support clinical progress

Newron Pharmaceuticals has announced positive top-line results from its Phase II trial (study 014) assessing evenamide, a glutamate modulator, as an add-on therapy to antipsychotics in moderate-to-severe treatment resistant schizophrenia (TRS). While detailed data (for the full 161 patient cohort over the six-week treatment period) have not been disclosed, management asserts that the results were similar to the six-week interim safety and efficacy data from the first 100 patients reported in Jun

Newron Pharmaceuticals - A year ahead of clinical milestones for evenamide

Newron has released its annual report and provided an operational overview for evenamide as a potential schizophrenia therapy. Positive interim data for the Phase II (study 014/015, in treatment-resistant schizophrenia, TRS) was shared in Q123 with similar results demonstrated in the full/top-line six-week data for all enrolled patients (released on 20 March 2023). The Phase III (study 008A, for patients on antipsychotics but not with TRS) is ongoing; results are expected in H223. Newron is prep

Newron Pharmaceuticals - Evenamide efficacy still going strong after 52 weeks

Newron Pharmaceuticals has announced positive interim results from the first 100 randomised patients completing one year of treatment (77 out of 100) in the Phase II 014/015 clinical trial (international, open label, rater-blinded study), in which evenamide is an add-on therapy to antipsychotics in moderate to severe treatment-resistant schizophrenia (TRS). The data are consistent with a gradual and sustained pattern of improvement in key efficacy measures compared with results after six weeks a

Newron Pharmaceuticals - Positive interim trial results in schizophrenia

Newron Pharmaceuticals’ share price has responded well to its announcement of encouraging interim efficacy data for the use of evenamide as an add-on therapy to antipsychotics in moderate to severe treatment-resistant schizophrenia (TRS). Patients who completed (85 out of 100) the six-month (30-week) treatment period (study 015) were found to show statistically significant and clinically meaningful improvements in the symptoms of psychosis. Importantly, the six-month data showed a sustained and

Newron Pharmaceuticals - Evenamide catalyst approaching

Newron Pharmaceuticals is focused on the development of novel compounds for the treatment of various neurological conditions. Heading the R&D pipeline is evenamide, which is being investigated for the treatment of schizophrenia. In September 2021, the drug began a Phase III pivotal trial (Study 008A) in this indication, with top-line results expected in H123. Positive results here would represent the most significant near-term catalyst for the company, in our view. In June 2022, Newron reported

Newron Pharmaceuticals - Evanamide potential expanding in schizophrenia

Newron Phamaceuticals has announced encouraging interim safety and efficacy data for the use of evanamide, a glutamate modulator, as an add-on therapy in treatment-resistant schizophrenia (TRS). Data from the first 100 patients who completed the six-week open-label study 014 (assessing the drug candidate as an add-on in moderate-to-severe TRS) found it improved symptoms of psychosis. A high proportion (77%) of all treated patients responded to their antipsychotic (AP) therapy after the addition

Newron Pharmaceuticals - Pivotal progress on schizophrenia therapy

Newron, a Switzerland-quoted Italian company, is developing evenamide (30mg twice per day) to meet the major unmet need for new therapies to help both poorly managed and refractory schizophrenia patients. Evenamide would add on to existing treatments. A potentially pivotal study is due to report by Q422. Newron hopes to partner evenamide for the larger market of patients no longer gaining the full benefit of current anti-psychotic therapies. Newron may directly sell evenamide to treat identified

Newron Pharmaceuticals - Evenamide validation underway

Newron is developing evenamide (30mg twice per day) as an add-on to treat poorly managed and refractory schizophrenia. A potentially pivotal Phase II/III study is underway and could report by Q422. Newron hopes to partner evenamide for larger indications while selling the product directly to the targeted clozapine-resistant market. H121 results showed Xadago royalties of €2.65m, up 6.5% over H120. The additional Xadago dyskinesia study due to start in Q122 could eventually boost US sales, but th

Shield Therapeutics - Termination of coverage

Edison Investment Research is terminating coverage on ABC Arbitrage (ABCA), paragon (PGN), Foresight Solar Fund (FSFL), Kendrion (KENDR), Lithium Power International (LPI), Triple Point Energy Transition (TENT), 4iG (4IG), e-therapeutics (ETX), Pharnext (ALPHA) and Shield Therapeutics (STX). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant. Previously published reports can still be accessed via our web

Cambridge Nutritional Sciences - Operational efficiencies; adjusted EBITDA profi

Cambridge Nutritional Sciences (CNS) has provided a trading update for the 12 months to 31 March 2024, noting that a combination of strong sales growth and significant margin improvements, driven by operational efficiencies, have played key factors in the group’s expectation of being adjusted EBITDA positive in FY 2024. Revenues are expected to be £9.8m (30% YoY growth), ahead of our £9.0m forecast, with gross profits expected to exceed £6m, which is again ahead of our year-end forecast of £5.6m

Warpaint London+ (W7L, House Stock at 375p) - Trading ahead of expectations - +10% upgrade implied

Cambridge Nutritional Sciences - H1 2024 interims: Executing a newly focussed st

Cambridge Nutritional Sciences (CNS) has published its H1 2024 results to end September 2023. Group revenues grew 44% to £4.9m and gross profits increased by 63% to £3.1m, with the company benefitting from newfound operational efficiencies. With its now streamlined strategy focussing on the core Health & Nutrition business and the initial signs of an encouraging uptick in sales momentum, we believe the company is well positioned for growth that will help create future value for shareholders. We

Hybridan Small Cap Feast - 22 April 2024

22nd April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing to acquire the entire issued share capital of 3radi

The Hardman & Co Monthly: April 2024

Feature article: Steady as she goes, but could be better: A review of investment company liquidity since 2016 Liquidity is the lifeblood of equity markets. The measurement of liquid asset availability to a market or company is a way of gauging a market’s health. This article builds on our previous work, which analysed the liquidity data for non-financial trading companies, by applying the same analytical techniques to the investment companies (IC) space. We analyse liquidity for ICs as a whol

e-therapeutics - Termination of coverage

Edison Investment Research is terminating coverage on ABC Arbitrage (ABCA), paragon (PGN), Foresight Solar Fund (FSFL), Kendrion (KENDR), Lithium Power International (LPI), Triple Point Energy Transition (TENT), 4iG (4IG), e-therapeutics (ETX), Pharnext (ALPHA) and Shield Therapeutics (STX). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant. Previously published reports can still be accessed via our web

Morning Note – 8 April 2024

Venture Life Group - Strong organic growth; focus on EBITDA

Venture Life has reported FY23 results to December 2023, following the February trading update. Revenues grew 17% in the year to £51.4m (our est. £50.7m) and adjusted EBITDA was £11.6m (our est. £11.6m). Cash conversion was 85%, generating £9.8m of cash from operations. Cash generation and no M&A in 2023 allowed the company to de-lever, closing FY23 with net debt to adjusted EBITDA at 1.3x. Management have focused on growth with three therapy areas generating double-digit revenue growth and onli

Hybridan Small Cap Feast - 17 April 24

17th April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing to acquire the entire issued share capital of 3radi

Shield Therapeutics - FY 2023 TU; total revenues in line but Accrufer scrip revi

Total reported revenues and other income were $17.5m (our forecast $16m) in 2023 vs $5.5m in 2022. The composition of that revenue was different to our expectations such that Accrufer US revenues of $11.6m compared with $3.6m in 2022 but came in below our estimate of $13.6m. In the release, the company has noted that the methodology used by the third-party data provider for US Accrufer scrips has resulted in an overstatement for 2023. Revised figures for 2023 have been given showing 77,000 total

ANGLE: Building content to drive widespread adoption

ANGLE’s investment case rests on where Parsortix’s position in mainstream cancer diagnostics eventually lands. The place of liquid biopsies is now established and, increasingly, the additional clinical value that CTC (circulating tumour cells) assays bring is becoming clear. Addressing the many, varied opportunities directly is challenging and time consuming, with numerous barriers to overcome. Management is creating industry awareness through its demonstration and acceleration activities, which

LIBERUM: Futura Medical: An increasing degree of confidence

Hybridan Small Cap Feast - 23 April 2024

23rd April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: Bidstack Group (BIDS.L) has left the AIM market What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing to

Warpaint London - Returning to growth

Warpaint London's strategy is to provide customers with access to an extensive range of high-quality and affordable cosmetics. Its focus has been to develop its flagship brand, W7, while capitalising on the growth potential of e-commerce and international expansion. Although the pandemic caused the temporary closure of a number of customer retail outlets, the business remains in a strong position thanks to management’s agility. Cash has been conserved and the business is now debt free. Given its