$NWBO Catalyst List Update 2023-24
As recently posted on Twitter, here is an Updated List of the probable & possible forthcoming Catalysts for NWBO in the next 18 months, in the rough order that I could imagine them happening:
- UK MHRA MAA Submission ✅ (Submitted 20th December)
- UK MHRA MAA Acceptance ✅ (Assumed Completed Early January. No PR Expected)
- New Drug Submission (NDS) to Health Canada's Health Products and Food Branch (HPFB)
- UK MHRA Marketing Approval
- Partnership/ Franchisee and/or Financing Deal(s) Announced. MRK, REGN, Oncovir, Revimmune, others…?
- Exchange Uplisting to NYSE/ NASDAQ… leading to >
- Institutional Capital Flood. Initial Analyst Coverage & initial media coverage & excitement
- Flaskworks Approval
- Court Case Motion to Dismiss thrown out.
- NICE Coverage Approval for treatment by NHS
- Short Covering (~46.6mil shares) begins to take-off circa $1.25
- FDA BLA submission
- Other MAA Submissions (potentially via Project Orbis or via IRP - International Recognition Procedure)
- Charles River Laboratories CDMO Contracts for N.America (& possibly Amplify Bio too)
- Multiple new basket Combination Trials announced for both DCVax-L and DCVax-Direct to treat multiple other solid tumour cancers, both operable and inoperable! Possibly with different franchisees licensed the use of DCVax-L and/or -Direct for different indications.
- UCLA Brain SPORE Project 1 (Combo Trial): DCVax + PD-1 + Poly-ICLC + CSFR-1 (Pexidartinib) Commences
- Possible Naked Short Covering… (~??? Million shares…!)
- Advent Bio & CRL (& Amplify Bio?) CDMO Mass Manufacture Really Begins
- REVENUES!
- Seminal Combo Trial Results; Upcoming Publications & UK Compassionate Use Data Published:
- i) DCVax + Poly-ICLC (NCT01204684) ✅ (results published 8th May 2024 in Nature here)
- ii) DCVax + Poly-ICLC + PD-1 MRK's Keytruda (NCT04201873)
- iii) Study by NCI (NIH) Gene Expression Omnibus (GEO) using genetic profiling analysis into 'Glioblastoma Molecular Characteristics and Immune Microenvironment Associated with Survival Outcomes in Patients Treated with Dendritic Cell Vaccination' based on data taken from the DCVax-L Phase 3 trial.
- iv) Case Study into Owain James who underwent treatment with DCVax-L for a 14cm GBM and had regression of his tumour after only half could be removed via resection. Accepted for peer review as per SEC 10-K Form published 5th March 2024.
- v) UK Specials Program & other Compassionate Use data released (400+ patients showing agnostic applicability and outstanding survival statistics with no side effects)
21: DIPG Trial (PIP ?) using DCVax-Direct Commences possibly using Clearpoint Neuro Delivery System
22: FDA & Other Orbis Country Marketing Approvals
23: Possible Inclusion by and funding from Biden's CancerX Moonshot program
24: Massive settlement from Citadel et al Court Case with Potential Share Buyback/ Dividend Issue using funds
25: Combo Therapy Patent Approval (of both DCVax-L and DCVax-Direct with Checkpoint Inhibitors) - ⏳ "Grant of patent is Intended" on February 16, 2024 by the European Patent Office (EPO) EP14859634
26: Massive expansion in Off-Label usage
27: Wall Street Acceptance & Leading Bank Analyst Coverage
28: Tissue Agnostic Indications, DCVax-Direct & the start of unlocking the Neoantigen Database
29: Dendritic Cell Treatments beyond solid tumour Cancers (Viral, Leukemia; Bacterial; Anti-Senescence etc...)
Another potential catalyst, which is definitely not a sure thing (thus not listed above) is if Ms Posner managed to get the judge to implement a trading injunction against the defendants in the spoofing case. This would be a substantial catalyst. The shorts would be utterly screwed!
If I have missed any then please feel free to comment and substantiate below and I will endeavour to add them.
If anyone would like to read more about why I feel the above catalysts are on the way then I suggest reading the deepdive NWBO Synopsis I wrote back in May that is available for PDF download HERE.