Q1 report is out. Regarding the nanoenzalutamide project, it says:
” On the small molecules side, our nanoenzalutamide program reached an important inflection point during the quarter. Feedback from a European scientific advice meeting confirmed the strong scientific rationale for the product, its high quality and the robustness of the supporting data package. At the same time, this regulator held the opinion that under the current legal framework, a hybrid generic application cannot proceed in its present form, as full compliance with all standard bioequivalence criteria remains mandatory. While this means the dossier submission originally targeted for this month will be delayed, the process has provided guidance on the pathways available to move forward. Together with our consortium partners, we have therefore after careful consideration decided to pursue a parallel multitrack strategy. We are evaluating selected national submissions in European markets that may accept the current data package, with the aim of using such approvals as a basis for broader access over time. We are also advancing further formulation work to also meet the remaining Cmax requirement. And we are assessing a non-generic pathway for the current product profile, which we believe remains scientifically and commercially compelling given its benefits and convenience for patients. These alternatives will require some additional spending on formulation work, but should not have a substantial cash flow impact on Nanoform, as we will continue to be paid for the work we perform. More important than the direct costs, however, is the impact on timing. Over the coming months and quarters, we expect to gain greater visibility through discussions with national authorities in Europe, feedback from the FDA, progress from formulation and preclinical/clinical work. Overall, all parties continue to see a meaningful global opportunity for nanoenzalutamide and its unique non-infringing formulation and believe the product can still reach the market potentially as early as 2028 and clearly before 2030, still many years before the end of the originator product’s secondary formulation patents run out.”
With the benefit of hindsight, one has to wonder. This was already foreseeable a year ago when the fasted dosing results came out, where Cmax fell outside the required range. Now, in short, it’s being said that EMA approval (and surely not FDA approval either) is not coming as things stand, and they are considering whether to apply for approvals in individual countries, conduct a non-inferiority study aiming for EMA marketing authorization (expensive, takes time), or re-develop the product so that applying via the generic pathway would be possible (within Cmax and AUC limits). This additional information coming over the “coming months and quarters” and a potential delay of years from the plan sounds bad, as this drug was supposed to provide the path to cash flow positivity. At the end of Q1 2027, there should still be 10 million in cash left if the cash burn continues as currently forecasted (but the burn will accelerate if nanoenzalutamide proceeds to a non-inferiority study).