From Pessimism to Mega Deals: The New Biotech Playbook for Funding, Focus, and Commercial Reality
Kicking off with contrarian receipts, the chair (Darkhorse Consulting Group) framed a market that’s bifurcated: mega rounds for the few with line-of-sight to launch, and a drought for everyone else. Investors and founders compared notes on what unlocks those big checks, why “platform” is no longer a pass, and how to avoid building a great Phase 1 machine that never becomes a real business.
Mega deals are back. Small checks aren’t. If you want the big money, show the path to patients—and build the syndicate, story, and partnerships to get there.
Session Chaired by Anthony Davies, Founder & CEO - Dark Horse Consulting. Panelists include, Richard Kashula, Principal - NG Bio · Bruno Montanari, Partner - Seroba Life Sciences · Raphael Ognar, Chief Executive Officer - NKILT Therapeutics · Aaron Edwards, Co-Founders & CEO - KiraGen Therapeutics
TL;DR
In a hurry? Here are the essentials at a glance:
Yes, funding is tough—but $100M+ rounds are flowing across modalities when commercial paths are clear.
Small rounds are scarce; asset-first storytelling beats platform platitudes.
It’s a people business: relationships, trust, and a sparring-partner board take time to build.
Partner early with pharma; most biotechs won’t (and shouldn’t) go it alone to launch.
Pricing is a PR problem now; cost has improved, but value-only pricing can backfire.
Access matters: <20% of eligible U.S. patients get autologous CAR-T—off-the-shelf models will be key.
Think globally: cross-border syndicates and “regulatory arbitrage” (X-US trials) are strategic levers.
Tranching is fair—if milestones and valuations are clear up front.
Founders: propose the plan; investors pressure-test. Don’t outsource the steering wheel.
The contrarian read: it’s the era of the mega deal
Sentiment may be gloomy, but nine-figure rounds keep landing across advanced therapies—preclinical through Phase 3. The common thread isn’t modality; it’s a credible route to launch: a specific patient, a solvable access path, and payer-believable benefit.
“Investors will invest preclinical or Phase 1/2—if they see a clear path all the way to commercial success.” —Anthony Davies, Dark Horse Consulting
What unlocks nine-figure rounds (and why many don’t)
It isn’t just the deck—it’s trust built over months of clean execution and transparent trade-offs.
“At day’s end it’s a people business; you build comfort, then row in the same direction.” —Bruno Montanari, Seroba Life Sciences
Patterns the panel sees in winners:
Asset-first story: a lead with obvious product-market fit; the platform explains speed or breadth, not the reason to exist.
Line-of-sight milestones: IND → FIH → early efficacy → confirmatory readouts mapped to trancheable capital; each milestone kills risk a sophisticated buyer actually cares about.
Syndicate physics: insider re-ups + reputable new money; KOLs and potential BD partners pre-wired so validation isn’t carried by the round alone.
Operators who scale: teams that move from four to forty without chaos, professionalize QA/CMC/Reg, and still hit the plan on time and budget.
Platform vs. product: the market has chosen
Five years ago, platform promise could carry a raise. Not now. You still need a platform moat (IP, data packages), but the narrative must anchor on a clinical asset and why it wins clinically and commercially.
“You need a clinical asset plan—and why it wins—even if you’re preclinical.” —Richard Kashula, NG Bio
Treat seed as an execution test: turn in vitro into in vivo fast, set go/no-go gates, and retire nice-to-have science that doesn’t serve the lead.
Do you need a mega round? Two viable paths
Pro-mega: With launch misfires fresh, some syndicates prefer large—but tranched—rounds that finance to meaningful human data (or further). Upside: fewer financing cliffs and room for quality CMC/market-access work. Downside: higher post-money and tighter performance scrutiny.
Capital-efficient: Others purposely run lean to first-in-human to prove a faster, cheaper playbook (and entice pharma earlier). Upside: less dilution and sharper proof points. Downside: thinner buffers for delays and fewer parallel shots.
Both camps agree: tranching is normal; clear, pre-negotiated valuation/milestone rails keep it fair.
Commercialization isn’t optional (and it probably isn’t yours)
Biotechs discover; pharma launches. The big commercial wins in cell & gene therapy rode early alliances that turned into acquisitions, bringing scale in clinical ops, market access, distribution, and field teams.
“We’re effectively building three companies—research, clinical, commercial—and leadership may need to change by phase.”
Bake launch thinking in now: HTA and pathway mapping, center-of-excellence models, and distribution assumptions belong in your Series A/B plan—not six months pre-approval.
Pricing & perception: from COGS debate to PR risk
Manufacturing costs have improved; uptake hasn’t always followed. Value-only pricing can backfire if access breaks, leaving approved products with negligible real-world use.
The lesson: access, affordability, and delivery determine impact. Design outcomes-based or annuity models early, pilot with select centers, and be explicit about how patients actually receive therapy. When you can show utilization, price narratives get easier.
Access reality: why off-the-shelf matters
In the U.S., fewer than one in five eligible patients receive autologous CAR-T—logistics and capacity are the blockers. The panel’s view: broad indications (especially solid tumors) require allogeneic/off-the-shelf models to scale like antibodies.
“We want to be the Keytruda of cell therapy—treat many more patients with models that can actually scale.”
Engineer for community settings and earlier-line use: predictable slots, shorter vein-to-vein, and workflows hospitals can run without heroics.
Go global: syndicates and “regulatory arbitrage”
Founders are mixing geographies by design:
Cross-border cap tables widen follow-on capacity, BD routes, and talent networks; they also diversify exit paths (regional deals, dual-track IPOs).
Regulatory arbitrage: if one region slows early clinicals, start where you can move—then bridge. Plan for data acceptability and comparability; set governance that works across time zones and legal frameworks.
“Be nimble—if the U.S. isn’t conducive right now, run ex-U.S. to reach human data faster.” —Anthony Davies, Dark Horse Consulting
“We quickly shifted to an ex-U.S.-first path; your backers need to flex when the plan changes.” —Aaron Edwards, KiraGen Therapeutics
Roles that work: founders propose, investors challenge
Boards shouldn’t run companies; great founders don’t outsource the plan.
“Management brings the proposal; investors pressure-test. That’s how speed and accountability survive.” —Bruno Montanari, Seroba Life Sciences
Codify the working model (monthly operating metrics, pre-reads, “disagree & commit”), and protect founder bandwidth. Expect a lot of “no’s;” practice with lower-priority funds before your top targets, and refine the story each time.
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