THE CHALLENGE
Late-stage clinical failure is the single largest driver of R&D waste. Clinical trials consume the majority of sunk capital, leaving companies exposed to multi-hundred-million dollar write-offs when late candidates fail. In traditional drug development, only about 1 in 10 programs successfully reaches approval. This means the cost of all failed candidates is effectively absorbed by the one that succeeds – driving the average cost per approved drug to around $2.5 billion.

The cost of traditional drug development

$2.5 billion

Average cost to market per drug

>10 years

Average time to bring a drug to the market

>90%

of new drugs that show efficacy fail in clinical trials

OUR SOLUTION
Organoids are the first and only technology to enable predicting human drug response at the preclinical phase. We have shown that drug testing on HUB Organoids, patient-derived in vitro cell models, directly correlates with the response of patients in oncology and other diseases.
Cumulative cost $0M
$0M
with Organoids

Portfolio-level costs (adjusting for ~10% success rate) without organoids ~$2.5 B and with organoids $1.8 B.
With an estimated capital efficiency gain of ~30-40% i.e. $400 M per program

The economic value of organoid-based screening

Organoid technology changes the R&D cost curve. By enabling more accurate human-response testing in the preclinical phase, companies can fail fast and redirect investment earlier. This might mean slightly higher preclinical costs, but preventing many of the expensive Phase II and III failures that consume the majority of R&D budgets. Across a portfolio, this shift delivers 30–40 % greater capital efficiency, translating to savings of $400 million or more per program, shorter development timelines, and higher confidence in clinical success.

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How Merus used organoids to advance their bispecific antibody (Pentosemtamab®) to the clinical trials in just 5 years

The biotech Merus was acquired for $8 billion on the strength of a single clinical asset – Petosemtamab – whose efficacy was tested exclusively using HUB Organoids. Seeking to identify a clinical candidate for a targeted patient population from a proprietary bispecific antibody library, Merus and HUB screened over 500 bispecific antibodies for general efficacy, selecting 24 leads that demonstrated high anti-tumor activity, low toxicity, and broad genetic relevance.

The lead molecule, Petosemtamab, was then validated against an expanded panel of 80 patient-derived organoids to predict clinical efficacy and guide its progression to the clinic. Today, a global Phase 3 trial (LiGeR-HN1, NCT06525220) is evaluating Petosemtamab in combination with pembrolizumab for the first-line treatment of PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The U.S. FDA has granted the combination Breakthrough Therapy Designation, and Merus is also exploring Petosemtamab’s potential in additional indications, including colorectal cancer.

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Early adopters are turning organoid
data into competitive advantage.

Join the companies redefining clinical predictability

 
 

Are you ready to expedite your drug development program?

By adopting organoid technology early in development, pharma leaders are cutting late-stage attrition, strengthening portfolio capital efficiency, and increasing the odds of blockbuster approvals. Want to discuss your research program with us?

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