Oryzon Genomics - FDA green light for SCLC combination trial

With the FDA investigational new drug (IND) application clearance, Oryzon can commence its Phase I/II cooperative research and development agreement (CRADA) trial sponsored by the National Cancer Institute (NCI; part of the National Institutes of Health) with Dr Noura Choudhury from the Memorial Sloan Kettering Cancer Center (MSKCC) as the principal investigator. This trial will evaluate iadademstat in combination with immune checkpoint inhibitors (ICIs) for the treatment of first-line extensive

Oryzon Genomics - Third time is a charm; INNOVATIVE SME Seal

For the third consecutive time, Oryzon Genomics has received the INNOVATIVE SME Seal from the Spanish Ministry of Science and Innovation. This external recognition highlights Oryzon’s key R&D activities, including its lead central nervous system (CNS) asset, vafidemstat, and lead oncology asset, iadademstat, and overall contributions to the field of epigenetics. Along with the acknowledgement, the INNOVATIVE SME Seal may allow Oryzon to benefit from certain tax deductions and incentives, as well

Oryzon Genomics - Approaching a period of inflection

ORY FY23 results announcement covered an eventful period for the company’s pipeline, capped by the release of top-line data from the Phase IIb PORTICO trial for lead CNS asset vafidemstat. With the focus squarely on the planned end of Phase II (EoP2) meeting with the FDA and anticipated clinical updates on the remaining programmes, we see FY24 as a crucial period for the company, with multiple inflection points. Other key upcoming milestones include results from the FRIDA trial (iadademstat in F

Oryzon Genomics - KOL event: Offering a real-world solution in BPD

Oryzon hosted a key opinion leader (KOL) event highlighting the potential of vafidemstat in borderline personality disorder (BPD). The KOLs discussed the limited options for treating BPD, as there are no approved drugs, and the current therapies are often ineffective. While the PORTICO trial did not reach statistical significance on its primary endpoints, vafidemstat was favoured over placebo in all efficacy measures, with statistical significance in two key secondary endpoints. During the event

Oryzon Genomics - PORTICO update with planned FDA EoP2

Oryzon Genomics has announced top-line results for the Phase IIb trial (PORTICO) assessing vafidemstat in borderline personality disorder (BPD), and while the primary endpoints (Borderline Personality Disorder Checklist (BPDCL) and Clinical Global Impression – Severity Agitation/ Aggression (CGI-S A/A)) did not reach statistical significance, vafidemstat was favoured over placebo in all efficacy measures, with nominal statistical significance in two key secondary endpoints (Borderline Evaluation

Oryzon Genomics - Grant to bolster ALS pipeline, add funding

Oryzon has announced the receipt of a $0.5m grant from the Amyotrophic Lateral Sclerosis (ALS) Association to support the regulatory clinical development of the company’s histone deacetylase 6 (HDAC6) inhibitor, ORY-4001, as a potential treatment for ALS. We view this as a favourable advancement that enables the company to expand its preclinical pipeline. This news of this funding grant follows on the heels of Oryzon’s recently announced €45m convertible financing arrangement. Oryzon plans to pr

Oryzon Genomics - Key €45m funding to back strategic priorities

Oryzon has secured funding of up to €45m through a revised convertible bond financing agreement with Nice & Green, a Switzerland-based institutional investor, which is anticipated to extend Oryzon’s cash runway to end-FY25. The new agreement supplants the previous €20m convertible bond agreement with Nice & Green, out of which €8m was pending withdrawal. We consider this announcement to be a critical development, especially in light of the overall macroeconomic environment. Management is expecte

Oryzon Genomics - Q323 recap ahead of key clinical stages

Oryzon’s Q323 results recapped the clinical progression across its drug development pipeline. The company continues to develop therapies that address unmet needs related to the central nervous system (CNS) and oncology. As noted previously, an important development was the positive safety data for the PORTICO trial, assessing vafidemstat in patients with borderline personality disorder (BPD). Oryzon continues to enrol patients for its lead oncology trial (FRIDA), investigating iadademstat as a p

Oryzon Genomics - Favorable safety reported in PORTICO Phase II

Oryzon presented a positive update on vafidemstat’s ongoing Phase IIb PORTICO trial in borderline personality disorder (BPD) at the ECNP Congress. The aggregated blinded safety data, as of 23 August, demonstrated a well-tolerated safety profile for a cohort with baseline characteristics reflecting real-world demographics of a typical BPD population. This is a critical consideration for therapies to progress and be successful once commercialised. We also note a low rate of discontinuations (2%) d

Oryzon Genomics - Grants provide confidence and expand portfolio

Oryzon has announced that it has received two separate grants from the Spanish State Research Agency and the Ministry of Science and Innovation to conduct two different public-private collaboration projects. These two-year studies – the DICTIONIS Project (€0.95m budgeted cost) and the MODERN Project (€1.33m budgeted cost) – aim to discover and validate novel biomarkers and epigenetic targets for the treatment of neuronal pathologies. The grants give us confidence in management’s ongoing efforts

Oryzon Genomics - H123 progress and results came in as expected

Oryzon’s H123 results highlight the continued progress of its lead clinical-stage assets, including positive aggregate safety data from the Phase IIb PORTICO trial assessing vafidemstat in borderline personality disorder. The company also indicated that enrolment is proceeding for the Phase IIb EVOLUTION trial (assessing vafidemstat in schizophrenia) and for the Phase Ib FRIDA trial (evaluating iadademstat in acute myeloid leukaemia, (AML)). Total H123 operating expenses were up by only 0.5% y-o

Oryzon Genomics - Positive safety data for vafidemstat in PORTICO

Oryzon has announced positive aggregate safety data for vafidemstat, which is being evaluated in the ongoing PORTICO trial as a potential treatment for borderline personality disorder (BPD). The independent data monitoring committee (DMC) has reviewed the safety data from the first 167 patients treated in the trial and reported no cases of treatment-related serious adverse events (AEs) or deaths. The DMC has therefore recommended that PORTCIO proceeds without modification until patient enrolment

Oryzon Genomics - Advancing on multiple clinical fronts in Q1

Oryzon has reported Q123 results highlighting its near-term strategic priorities, including a favourable interim analysis of its lead asset study, the Phase IIb PORTICO study (vafidemstat, central nervous system, CNS), and the commencement of patient enrolment for the Phase Ib FRIDA study (iadademstat, oncology). Total operating expenses stood at $5.6m for Q123, largely similar to Q122, with the majority (78.1%) from R&D expenses ($4.4m) as Oryzon continues to advance its clinical pipeline. With

Oryzon Genomics - Promising PORTICO interim results

Oryzon has announced promising results from an interim analysis of the Phase IIb PORTICO study, a trial evaluating vafidemstat as a treatment for borderline personality disorder (BPD). An independent data monitoring committee (IDMC) conducted an analysis of the first 90 patients who completed the treatment and recommended that the trial continue without any modifications to the design. These interim results, along with positive safety data reported in September 2022, are encouraging for the clin

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

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

Avon Protection - Unmasking its growth potential

Avon Protection’s capital markets day highlighted its continued focus on medium-term margin expansion (targeting operating margin of 14–16%), concentrating on its core business of respirators and head protection. The unwinding of the armour business, alongside the consolidation of Team Wendy (acquired in H220) should enable Avon to benefit from rising global defence spending. Its strong relationship with the US DoD, and organic growth opportunities with recurring revenue from necessary product r

Hybridan Small Cap Feast - 15 April 24

15th 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: Change of Market: TheWorks (WRKS.L) a multi-channel value retailers of books, arts and crafts, stationery, toys and games, offering customers a differentiated propositio

Morning Note – 9 April 2024

Morning Note – 8 April 2024

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

Hardman & Co Research: Tissue Regenix (TRX) - Six consecutive periods of >20% growth

TRX is focused on the development and commercialisation of two proprietary processing technologies for the repair of soft tissue (dCELL®) and bone (BioRinse®). It has a broad portfolio of products used in biosurgery, orthopaedics and dental markets. Investment in tissue processing, manufacturing capacity and strong commercial partners, together with its “4S” strategy, has generated six consecutive reporting periods of strong growth, with TRX turning EBITDA-positive in 2023. Further growth in 202

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

Morning Note – 22 March 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

Creo Medical - Solid FY23 lays the groundwork for 2024

Creo Medical has released a trading update for FY23, an active year for the company, with progress made across all business segments. Traction improved in H223, following Speedboat Inject’s European clearance for upper gastrointestinal (GI) procedures and the accelerated approval and launch of Creo’s slimmest electrosurgical device, Speedboat UltraSlim. Top-line growth was supported by continued streamlining of the cost structure, resulting in a better-than-expected underlying EBITDA loss (impro

Hardman & Co Healthcare Index: 2023 – Capital demands dent performance

The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the second year running, apart from global economic influences affecting world markets, performance in 2023 was dented by the capital-intensive nature of the sector. The HHI fell 3.7%, to 483.8, underperforming the main London markets – FTSE 100 (+3.8%) and FTSE All-Share (3.8%) but outperforming the FTSE AIM All-Share Index (

Warpaint London + (W7L, House Stock at 382p) - Late-year sparkles– another double-digit upgrade to FY23F EPS

Zoetis Inc.: Launch Of CircoMatch & Other Drivers, Financial Forecasts, DCF & Comparables Valuation, ESG & Other Risks (02/23)

Zoetis delivered a decent set of results for the last quarter of 2022 meeting analyst expectations as well as the high end of its management guidance. Despite the economic challenges, ongoing pandemic recovery, and the political unpredictability brought on by the war in Ukraine, they delivered operational growth for the year in each of their top 13 markets. The company's unique companion animal portfolio drove its 8% operational revenue increase for the year, growing 14% operationally. In compar