WHY THIS MATTERS

Jeff,

J&J just wrote off $1.25B on Numab’s IL-4/IL-31 bispecific for atopic dermatitis after Phase 2b futility, while Genmab killed their PD-L1x4-1BB bispecific in oncology. Both failures involved bispecific antibodies from established players with deep pockets—exactly the competitive landscape you’re entering as you position FALKYN’s dual T/B cell bispecific for SLE/LN. This should shape how you frame differentiation and de-risk perception heading into your IND filing and Series A conversations.

Strategic context

The bispecific narrative is getting harder to sell on concept alone. J&J paid peak-hype valuation for Numab mid-2024 and pulled the plug within months when efficacy didn’t materialize—investors will now demand clearer proof of mechanism advantage before pricing in platform value. For you, this means your IND package needs bulletproof translational data showing why dual T/B cell depletion delivers clinical benefit beyond existing B-cell therapies. The silver lining: Big Pharma is still willing to pay massive premiums for differentiated bispecifics, but only with compelling preclinical-to-clinical bridging data.

Board/investor angle

Use this as a forcing function with your board: these failures validate that mechanism novelty alone won’t carry valuation through clinical stages. Double down on biomarker strategy and patient selection criteria in your IND-enabling studies to demonstrate predictive efficacy signals investors will now require after watching J&J’s writedown.