Emmanuele

$INO : The FDA decides today. My timeline is mostly debating whether INO-3107 works. The more useful question is which approval path the FDA takes, and there's a precedent in this exact disease that almost nobody is talking about. THE PRECEDENT In Aug 2025, $PGEN filed Papzimeos for accelerated approval. The FDA gave it full approval instead, no confirmatory trial required, on a single-arm study of 35 patients. So the FDA has already accepted single-arm data as enough in RRP. That's the bull case people miss: a traditional approval doesn't require beating an existing drug, just substantial evidence that yours works. THE CATCH INO-3107 is filed under accelerated approval. That pathway is meant for unmet need, and when an approved therapy exists, a new drug generally has to show a meaningful advantage over it. Papzimeos is now that therapy. That's why the FDA's filing letter flagged a preliminary concern about eligibility. In the Q2 update, Inovio said the FDA hadn't discussed it since, but told them feedback on the confirmatory trial design "would be forthcoming." Read that as the FDA working on an accelerated path with strings, not shutting the door. THE STRINGS Since FDORA (2022), the FDA can require the confirmatory trial to be underway before approval, or within a set time after. Its Jan 2025 draft guidance says "underway" means at least enrollment started and a credible completion timeline. For a company with $36.7M at June 30, ~$18.3M raised in July and ~$18M of quarterly burn, a randomized trial is a funding question, not a formality. THE DATA SIDE BY SIDE INO-3107, n=32: 28.1% needed no surgery (9/32), 81% had at least one fewer, ORR 72%. No treatment-related side effects above grade 2. About half surgery-free in year two. Papzimeos, n=35: 51% surgery-free in the 12 months after treatment (18/35), and 15 of 18 still in CR at 24 months. Not apples to apples: Precigen counted from after its 12-week dosing window, Inovio counts from day one. But the FDA will see the gap. THE STOCK ~103M shares plus up to ~98M from warrants, the July ones struck at $1.10. Above that, exercises add supply. Short interest ~20% of shares (Sept 30). Implied volatility around 250%. For scale: Precigen puts US adult RRP at ~27,000 patients, and Papzimeos did $53.1M in Q2. WHAT TO READ IN THE PRESS RELEASE 1. "Accelerated" or "approval" alone. Traditional approval is the best case. 2. "Confirmatory," and whether it has to be underway now. 3. The indication. Narrower than "adults with RRP" means a smaller market. A CRL citing eligibility means the FDA wants randomized data, and that's hard to fund from here. No position. #FDA #Biotech