Edison Investment Research - Oryzon Genomics (ORY) Oryzon Genomics - Multiple milestones anticipated in H224

Report

Edison Investment Research

Sean Conroy

Oryzon Genomics - Multiple milestones anticipated in H224

Oryzon’s Q224 results summarised an active quarter for its clinical pipeline, with multiple milestones expected in H224. Central to the H224 momentum will be the upcoming FDA end-of-Phase II (EoP2) meeting for vafidemstat in BPD, for which a positive outcome would provide impetus to subsequent plans. Interim data from FRIDA (iadademstat in AML) was encouraging, and with several additional combination trials planned, the second half of the year will continue to be highly active. Operating results threw no surprises, with R&D expenses remaining soft (€2.2m in Q224) following the PORTICO trial completion in late 2023. The period-end gross cash balance of €10.1m was supported by another €4m drawdown from the November 2023 convertible debt facility and should support operations into FY25. As we make minor revisions to our estimates, our valuation adjusts to €774.7m versus €748.8m previously. Our per share valuation remains unchanged (€12.1) on a higher post-conversion share count.

01/08/2024 1 EN

Underlying

Oryzon Genomics

Oryzon Genomics SA is a Spain-based biopharmaceutical company. It is engaged in the field of epigenetic medicine and in the development of therapeutic, biological solutions for cancer and neurodegenerative diseases. The Company's business model focuses on identifying biomarkers that can be translated in new therapeutic targets, as well as on investing in programs, mainly through the development of small molecules for two main indications: cancer and neurodegeneration. The Company develops investigational medicines till proof of concept (POC) phase and then partners the program with pharmaceutical entities, which are able to get the approval from drug agencies to bring these medicines to the patients. It cooperates with Roche. The Company is a subsidiary of Laboratorio Reig Jofre SA.

See profile

ES0167733015 Madrid Stock Exchange Spain

Provider

Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

See profile

Analysts

Sean Conroy

Other Reports on these Companies

Edison Investment Research

Oryzon Genomics - Q3 results recap key upcoming inflection points

Oryzon has reported its Q324 results, the highlight of which was the borderline personality disorder (BPD) programme, with the final Phase IIb PORTICO data demonstrating vafidemstat’s potential to offer meaningful results in a condition with no approved drugs currently. A further boost was the positive FDA feedback for Phase III, and the next step will be the submission of a full trial protocol for PORTICO-2 (expected in Q125). Oryzon also made strides in strengthening its intellectual property (IP) profile, extending vafidemstat’s patent protection up to at least 2040. In oncology, the first ...

October 30, 2024 October 30, 2024 1 EN

GlobeNewsWire

ORYZON Reports Financial Results and Corporate Update for Quarter Ended September 30, 2024

ORYZON Reports Financial Results and Corporate Update for Quarter Ended September 30, 2024 Final data from PORTICO, global Phase IIb vafidemstat trial in BPD, presented at the 37th ECNP annual conference in SeptemberCompany moving forward with PORTICO-2 Phase III trial preparations following positive feedback from End-of-Phase II meeting with the FDA Company continues to strengthen IP position for vafidemstat with additional “intention to grant” communications First cohort dosed in Investigator-initiated Phase Ib study of iadademstat with venetoclax and azacitidine in first-line AMLReductio...

October 24, 2024 October 24, 2024 1 EN

Edison Investment Research

Oryzon Genomics - FDA aligns on Phase III BPD plans

Oryzon Genomics has confirmed the FDA’s alignment with its proposed Phase III programme for vafidemstat in borderline personality disorder (BPD). Notably, the FDA acknowledged agitation and aggression (A/A) as a therapeutic indication and, as such, the State-Trait Anger Expression Inventory 2 (STAXI-2) Trait Anger may be used as a primary endpoint for Phase III (PORTICO-2). We note that vafidemstat showed statistically significant benefit by this measure in the prior Phase IIb PORTICO trial. We view the news as encouraging and believe there is a sizeable opportunity for Oryzon to develop an ef...

October 2, 2024 October 2, 2024 1 EN

Accsys Technologies - Upgrading guidance for the full year

Accsys Technologies had a strong H125 with a return to revenue growth and gross margin exceeding its target of 30%. Adjusted EBITDA improved on the back of better than expected volume growth from the plant in Arnhem. The company has simplified and de-risked the group through the successful start-up of the plant in the United States and the decision to discontinue the project in Hull. After the good start of the year, Accsys increased guidance for the full year, with underlying profitability expected to improve in H2 as Accoya USA continues to ramp up.

12h / 53m 12h / 53m 1 EN

Kate Heseltine

Kate Heseltine

Topps Tiles - Market outperformance again in FY24

Topps Tiles (TPT) has reported a good profit outturn for FY24, ahead of our prior expectations, which is encouraging in the context of the challenging external environment. Management believes the overall revenue decline of 5% means TPT has once again outperformed the market that it estimates to have declined by 10–15%. TPT has made good early progress on the key growth areas under its recently announced Mission 365 strategy, which are expected to drive the bulk of the growth in the medium term. With respect to the outlook for FY25, TPT has returned to positive revenue growth in the first eigh...

14h / 13m 14h / 13m 1 EN

Toby Thorrington

Toby Thorrington

Nabaltec - Resilience and margin expansion

Nabaltec recorded revenue growth across the group of 1.5% y-o-y to €158.2m at 9M24, with sales volumes increasing 7.9% y-o-y despite selling prices falling. Functional Fillers revenue grew by 3.8% y-o-y to €114.1m due to strong demand for its viscosity optimised and fine precipitated aluminium hydroxides. Speciality Alumina revenue, however, decreased 4.1% y-o-y, partially offsetting group revenue growth due to a lack of impetus for reactive alumina in the wider market. Group EBIT grew 28.2% y-o-y to €16.8m (10.3% margin), due to higher capacity utilisation and lower costs of materials, energy...

November 25, 2024 November 25, 2024 1 EN

Sign-up for free to access full reports immediately

Email Address*

Choose Password* ( 6 or more characters )

Due to regulatory restrictions regarding the distribution of financial research, this report is restricted to a specific region or investor type. Get access to exclusive reports by answering the questions below.

Select your country*

Get financial insights straight to your inbox

By clicking "register" you accept the Terms and Conditions & Privacy Policy

Already on ResearchPool?

Almost there...

Are you a professional investor?

Select your country

REGISTER

Create a free ResearchPool account to access full reports, get a personalised dashboard and follow providers or companies

In order to access this report please create an account.

LOGIN

Oryzon Genomics - Multiple milestones anticipated in H224

Oryzon Genomics - Q3 results recap key upcoming inflection points

ORYZON Reports Financial Results and Corporate Update for Quarter Ended September 30, 2024

Oryzon Genomics - FDA aligns on Phase III BPD plans

Accsys Technologies - Upgrading guidance for the full year

Topps Tiles - Market outperformance again in FY24

Nabaltec - Resilience and margin expansion

Create a free ResearchPool account to access full reports, get a personalised dashboard and follow providers or companies

Sign-up for free to access full reports immediately

ResearchPool Subscriptions

Get the most out of your insights

Why subscribe?

How to subscribe

ResearchPool Subscriptions

This report is only available to subscribers

Why subscribe?

How to subscribe