The questions investors ask, answered before diligence.

The question

Will the first company to market lead the category ten years after approval — or will a new entrant take the lead?

CEACAM5 is a crowded antibody–drug conjugate target, with several companies in the clinic and more than 1,000 patents covering it. We set out to answer whether a first-mover advantage will hold, or whether the door is still open for a new entrant to become the category leader.

Our approach

1. Clinical trials. We analyzed 187 relevant clinical trials and found a major gap in patient enrichment. Today's trials address less than 15% of the market, which leaves the rest open to new entrants.
2. Diagnostics. The diagnostic in current use is the main reason trials are so narrowly focused. We designed alternative diagnostics that are feasible with today's technology and could expand the addressable population by an estimated 40–50%.
3. Patent estate. We analyzed more than 1,000 patents covering antibodies, payloads and linkers. The estate is large but permeable, and we identified clear paths for a new entrant. Our recommendation was to build defensible niches rather than rely on patents alone.
4. Competition. We analyzed 44 competitors and identified platform substitution — a rival technology displacing ADCs entirely — as the biggest long-term risk, then developed strategies to counter it.
5. Standard of care. We analyzed the current standard of care and the routes to first-line inclusion, and outlined an approach a new entrant could use to reach first-line therapy.

The question

How does a rehabilitation app with a 30–45-day treatment cycle build recurring revenue?

Our approach

1. Mapped the technology's reach. We studied applications of the tech stack beyond clinical rehabilitation and identified sports performance as the strongest adjacent market.
2. Structured a field-of-use licence. We licensed the technology for sports use in the US to a new entity in which the company holds a significant stake — a second revenue stream without diverting the core business.
3. Protected the expansion. We filed new invention disclosures to secure IP for the expanded applications.

Result

• Recurring demand: 77 US employers have agreed to host regular "kinesthetic hours" — workplace movement sessions delivered by physiotherapists the sports entity has retained — with more in discussion. A one-off rehab cycle has become ongoing demand.
• Scientific credibility: a five-member Scientific Advisory Board now guides development.
• Investor readiness: the company is positioned for its first institutional round.

The question

How does a preclinical oncology company with strong data but no clinical track record fund its way forward when investors hesitate?

The company had a differentiated modulator for a solid-tumour target, good preclinical data and a solid IND package. With no clinical-trial experience on the team, raising capital was difficult.

Our approach

1. Mapped adjacent fields. We analysed gaps, market potential and IP beyond human oncology, and identified veterinary oncology as a faster, lower-cost route to validation.
2. Carved out a narrow licence. We licensed the veterinary application only, with all human rights fully retained.
3. Protected the core asset. We kept the human programme unencumbered for a future partner or investor.

Result

• Runway: the upfront payment covered the company's burn, giving it breathing space without raising dilutive equity.
• Proof of concept: the canine programme generated efficacy data in naturally occurring tumours.
• Valuation: the company's valuation rose significantly.
• Human rights licensed: three years later, the company licensed its human rights to a partner — which also addressed its lack of clinical experience.

The question

How can a toxicology facility become the fastest route to the clinic for early-stage founders?

Our approach

1. Redesigned the offering. We moved the facility from standalone toxicology studies to complete IND packages.
2. Integrated the missing pieces. We added regulatory advisory and CMC through a network of collaborators, so founders deal with one team instead of several.
3. Extended the model into the clinic. We applied the same integrated approach to clinical development.

Result

• 29 complete IND and equivalent clinical-trial applications in three years, filed with the US FDA, EMA, Health Canada, and regulators in Singapore, Australia and India.
• A financial turnaround: revenue grew 2.5× over five years, and EBITDA moved from deeply negative to a margin above 30%.
• A Phase 2 programme delivered end to end in 18 months, covering CMC, formulation, regulatory approval, a 150-patient study, data analysis and reporting, with significant cost savings. The molecule has since advanced to Phase 3.

The question

Should a new NSAID challenge one of the best-selling drugs of the early 2020s in oral therapy — or find a route where it can lead?

Our approach

1. Avoided the head-to-head. We advised against an oral trial against the entrenched market leader and repositioned the molecule as a once-daily dermal therapy for humans.
2. Licensed the human programme. The dermal programme was licensed to a US partner.
3. Ran the Phase 2 study cross-border. We managed the CROs for a Phase 2 study registered in India and the US and conducted with patients in India, run jointly by the US licensee and the Australian originator.
4. Opened a second market. We ran market research in canine atopic dermatitis and formed a KOL group of veterinary dermatology experts affiliated with Ludwig Maximilian University Munich, the European College of Veterinary Dermatology, the University of California, the University of Copenhagen, the University of Wisconsin School of Veterinary Medicine and Bangalore Pet Hospital.
5. Developed a veterinary formulation. We managed its development through a CRO, working closely with the originator's scientists in Australia. We chose an oral formulation because dogs lick topical treatments off.

Result

• Human efficacy: the drug showed efficacy in a Phase 1b study in Australia and in a Phase 2 study with patients in India — the second completed after the licence.
• Unmet need: veterinary experts confirmed that current treatments fall short in canine atopic dermatitis.
• Veterinary progress: the short half-life — the main obstacle for veterinary use — was solved with a stabilised oral formulation that has cleared pharmacokinetic studies in rats.
• Next step: the veterinary programme is now positioned for licensing.