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Remember, the money is waiting on the other side of a door only tox opens. Go break some eggs.
👀 The Read
🤑 🤑 🤑
BioPharma Dive ran the first-half numbers Monday: 68 biotechs pulled in more than $9.1 billion between January and June — the strongest first half since the start of 2022. But look at who got it. About two-thirds of those rounds — 42 of them — went to companies that already had a drug in human testing. Seed capital and first-time founders are getting a fraction of what they'd have raised five years ago, and 76% of the money came in megarounds of $100M or more.
The read: the headline is "biotech funding is back." The real story is where the money stopped. Capital has quietly repriced preclinical as the risky part — which means your IND is no longer just a regulatory milestone. It's a financing milestone. What everyone's calling a seed crunch is a preclinical crunch, and the only bridge across it is your nonclinical package. That changes what those studies are for. Founders who win sequence the IND-enabling program against their cash and know exactly which single study sits on the critical path. Founders who lose treat nonclinical as a cost center — a bill to shrink before the real work starts — and run dry four months short of the one milestone that would have gotten them funded. The money didn't leave. It moved to the other side of a door you haven't opened yet.
One more signal worth reading: cell and gene therapy is stuck in a multi-year slump, and investors point to worrying side effects in trials and heavier regulatory scrutiny as part of why. Safety findings aren't just a regulatory problem anymore. They're repricing entire modalities.
❓ Sizing the gap between your runway and your IND? Reply — I read every one.
💭 The Decision
Scope to the package, or scope to the runway?
Every founder eventually faces this one, and most face it too late. You can design the nonclinical program you'd build with unlimited cash — every study, every contingency, maximum defensibility. Or you can design the one that gets you through the door before the money runs out. Those are different programs, and pretending otherwise is how companies die on the preclinical side of the gap.
The cost runs both ways. Scope to the ideal package and you burn runway on studies that weren't gating — you die four months short with a beautiful, unfiled dossier. Scope to the runway carelessly and you file something that doesn't hold, FDA stops you, and now you're raising with a hold letter in your data room, which is the hardest money in biotech to raise. The decision isn't how much nonclinical. It's which studies actually gate the IND, and does your cash reach them. Make that call before you commit to a CRO schedule — because sequence, once started, is expensive to change.
🔧 The Move
This week, put two lines on the same page: your nonclinical timeline and your cash-out date.
Then answer one question: what's the single longest-lead item between today and IND submission — and has it started?
For most programs it isn't a study at all. It's the drug substance. Your timeline is usually rate-limited by how fast chemistry can make the material your pivotal safety studies need — not by the CRO, not by the science. If that answer isn't already on your calendar with a date attached, that's your gap, and it's the cheapest one you'll ever fix.
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