To raise capital, biotechs need specific clinical data. Raj Devraj specifies the three essential components investors look for: 1) confirmation of good drug exposure in humans, 2) a favorable early safety profile, and 3) biomarker data that provides proof of the drug's biological mechanism. Lacking any of these makes fundraising significantly harder.

Rather than waiting for late-stage development, biotech startups should integrate commercial planning into early trials. This means building in data collection for payers, pricing, and patient access from the start. This "think with the end in mind" approach ensures the company has the right data for pivotal trials and market access.

Don't wait until Phase 3 to think about commercialization. Biotech firms must embed secondary endpoints in Phase 2 trials that capture quality of life and patient journey insights. This data is critical for building a compelling value proposition that resonates with payers and secures market access.

By first targeting T-cell lymphoma, Corvus gathers crucial safety and biologic effect data in humans. This knowledge about the drug's impact on T-cells directly informs and de-risks subsequent trials in autoimmune diseases like atopic dermatitis, creating a capital-efficient development path.

Cereno Scientific chose a Phase 2b trial over a combined 2b/3 to maintain flexibility. A combined trial locks in the design for both phases upfront, whereas a standalone 2b allows for optimization before Phase 3 and creates a cleaner, more attractive asset for a potential acquisition deal.

Despite reporting positive Phase 2 asthma data that met the company's stated goals for 12-week dosing, Upstream Bio's stock dropped significantly. The CEO attributes this to the 24-week dosing data being less robust on the primary endpoint, highlighting the gap between achieving clinical goals and meeting nuanced market expectations for a best-case scenario.

Using safety and preliminary efficacy data from its lead drug for MPS1, Immusoft successfully requested an FDA waiver for definitive toxicology studies for its next program in MPS2. This platform approach saves significant time and capital, accelerating the entire pipeline without 'reinventing the wheel'.

Despite FDA readiness for a final Phase 3 trial, Connect Biopharma chose to run more Phase 2 studies. They discovered their long-term asthma drug worked in hours, not weeks, and are now pivoting to prove its value in acute, emergency situations, which informs a stronger, more targeted Phase 3 design.

Upstream Bio believes its 12-week dosing schedule for verekitug is a significant patient advantage, even if efficacy only meets or exceeds existing drugs. The CEO states that market research confirms that reducing injections from 13 to 4 times per year is a meaningful improvement that can drive commercial success, prioritizing patient convenience as a differentiator.