Pitt Street Research’s Post

Pitt Street Research publishes an update note on Dimerix Limited, a company aspiring bring its DMX-200 drug to market for Focal Segmental Glomerulosclerosis (FSGS) and is in a Phase 3 trial which has shown solid interim results. The company secured its inaugural license deal in October 2023 with Advanz Pharma, and secured a second deal earlier this week with Taiba Middle East. Dimerix will receive up to ~A$120.5m in upfront and milestone payments in addition to tiered royalties, starting at 30% on net sales. The deal will also provide for Taiba to be responsible for submission and maintenance of the regulatory dossier in all of these territories, as well as all sales and costs of marketing activities. Collectively, these markets have a population of over 100m, and healthcare is free and government-sponsored. Companies can set the prices of orphan drugs according to either their price in the country of origin or in the US or Europe. We previously valued of Dimerix at A$0.64 per share in a base case scenario and A$0.84 per share in an optimistic case scenario. We update this to A$0.84 and A$1.07 per share accounting for the market opportunity and utilising our independent assumptions on the market size and predictions of the company’s market penetration. Please note that this report is General Advice only and is one that was commissioned by the company. Please refer to pages 7-8 for more details on our valuation and the key risks to our thesis. Marc Kennis Stuart Roberts Mark Diamond Nina Webster Hugh Alsop Sonia Poli Hamish George #dimerix #dxb200 #kidneyhealth #kidneydisease #biotech #biotechs #biotechstocks #healthstocks #ASX #equities #equityresearch #researchreport #researchinitiation https://lnkd.in/eyjWtZ8T

Dr. Terri Gaskell, CTO of Rinri Therapeutics, shares her insights on developing and manufacturing a PSC therapeutic at IMAPAC Biomanufacturing 5.0 conference today in London. Her advice? Begin with the end in mind. Don't just focus on what is acceptable in a First-In-Human (FIH) trial, but consider what will likely change to generate a commercial product. Dr. Gaskell emphasizes the importance of collecting everything while developing your manufacturing process. This will facilitate retrospective analysis and help you identify areas for improvement. Additionally, it's crucial to know the sensitivity, robustness, and limitations of your tools. Rely on them only as much as justified. Bank sufficient material to validate your assays if justified in risk assessment. Remember, developing a successful commercial product requires thoughtful planning and attention to detail. Thank you, Terri, for sharing your valuable insights. #productdevelopment #manufacturingprocess #commercialproduct #biotech #advancedtherapies #PSC

Thoughts on this? >> Cartesian clears an autoimmune CAR-T trial, starts another Phase 2 and raises $130M >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #pharma #healthcare #productmarketing #biotech

Thoughts on this? >> Cartesian clears an autoimmune CAR-T trial, starts another Phase 2 and raises $130M >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #pharma #productmarketing #pharmaceutical #healthcare

Strong evidence of the importance and power of Tscm !!.

This morning we published an update note on Dimerix Limited. The company's flagship asset, DMX-200, is in a Phase 3 trial for focal segmental glomerulosclerosis (FSGS). It is the only such product to be in Phase 3 for FSGS, and there are no treatments on market already. Earlier this month, the company released results of the first interim analysis and these showed positive results. Dimerix has several near-term milestones awaiting it such as the execution of potential licensing deals for available jurisdictions, (including the US and China), and recruitment and dosing of 144 patients for Part 2 (the second analysis outcome is estimated for mid-CY25). Dimerix is well poised to bring the drug to market with an existing commercial partner for Europe, Canada and ANZ in Advanz Pharma, and potentially more to come in jurisdictions not covered by Advanz Pharma. We update our valuation of Dimerix to A$0.63 per share in a base case scenario and A$0.83 per share in an optimistic case scenario. We have reduced the discount rate in light of the company’s results, but have also the increased the number of shares on issue after the recent capital raising. Please be advised that this report is General Advice only and is a report commissioned by the Company. Please see p.10 for the key risks and the final page for the full General Advice Warning, disclosures and disclaimers. #dimerix #dxb200 #kidneyhealth #kidneydisease #biotech #biotechs #biotechstocks #healthstocks #ASX #equities #equityresearch #researchreport #researchinitiation https://lnkd.in/gbCjh5va

🚨MORE STRUCTURE-BASED DRUG DESIGN NEWS 🚨 Boehringer Ingelheim announces collaboration with Sosei Heptares that could be worth over €𝟔𝟕𝟎𝐦 - utilizing the structure-based drug design platform of Sosei Heptares to treat ALL symptoms of schizophrenia. This marks yet ANOTHER significant investment being made by the biopharma industry as we continue to recognize the value of SBDD to treat previously undruggable targets using advances in structural biology techniques. Join us at the 𝐒𝐭𝐫𝐮𝐜𝐭𝐮𝐫𝐞-𝐁𝐚𝐬𝐞𝐝 𝐃𝐫𝐮𝐠 𝐃𝐞𝐬𝐢𝐠𝐧 𝐒𝐮𝐦𝐦𝐢𝐭 in 𝐁𝐨𝐬𝐭𝐨𝐧 this June at the only industry-led meeting that encompasses the most relevant, cutting-edge structural biology techniques from a third-party perspective. More Info: https://ter.li/nl7dkh Link to news: https://lnkd.in/dVpYVvDY Drop me a note if you have any questions. #SBDD #StructureBasedDrugDesign #XrayCrystallography #NMR #CryoEM #CryoET #DrugDesign #DrugDiscovery #StructuralBiology

We are pleased to confirm the execution of a co-marketing agreement with US contract research organisation Spanios.    This marks Inaphaea's first co-marketing agreement in the US, providing our high-throughput drug screening services with patient-derived cells (PDCs) as an initial step before transitioning to Spanios's proprietary patient-derived tumoroids (PDTs).    Mark Eccleston, Director of Inaphaea BioLabs comments: "We are excited to be working with a highly innovative partner like Spanios. Bringing therapies to market faster requires better models for screening drugs to deliver more accurate and translatable results. Inaphaea has focussed on the early stage of this process where, typically, larger numbers of candidates need to be refined for screening in disease relevant models. We can then pass on the best candidates to Spanios for testing in their organoid platform."    Read more about the agreement here: https://lnkd.in/efNMPqN6   #PDCs #BioTech #DrugDiscovery #Assays #AssayDevelopment

Thoughts on this? >> #EAN24: Dianthus teases preclinical data for autoimmune drug as its starts clinical trials >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #productmarketing #pharma #healthcare #biotech

Tissue Cross-Reactivity assays are a critical part of the drug development process. Get the latest insights in our whitepaper! Download now 👉 https://lnkd.in/eGty-j-z #drugdevelopment #lifesciences #cellularpathology #digitalpathology #tcr #whitepaper #drugdiscovery