Lucid Diligence Brief: myTomorrows $29 million funding to scale AI-enabled clinical-trial recruitment

Professional audiences only. Not investment research or advice. UK readers: for persons under Article 19(5) or Article 49(2)(a)–(d) of the Financial Promotion Order 2005. Others should not act on this communication.

Dive deeper

Seven questions, 60-second thesis frame.

What changed, and when

Amsterdam-based myTomorrows disclosed a $29 million (€25 million) growth investment on 11 Nov 2025 to expand its AI-enabled platform for clinical-trial recruitment, expanded access management, and real-world data services, with Avego as the investor (Company announcement). The company’s own note adds the round closed in Oct 2025 and will fund international expansion and product development (myTomorrows blog), with independent trade coverage corroborating the amount and investor identity (Tech Funding News, EU-Startups).

60-second thesis frame

Fresh capital from a healthcare specialist buys time to scale a regulated, workflow-heavy business that sits where trial enrollment, expanded access, and evidence generation meet. The platform’s proposition, discovery plus compliant access plus RWD, is timely given the FDA’s updated Expanded Access Q&A guidance on 22 Oct 2025 and ongoing EU compassionate-use frameworks (FDA guidance, EMA compassionate use, MHRA EAMS overview). Execution risk is non-trivial, multi-jurisdiction access rules and pharmacovigilance obligations are complex, pharma participation is discretionary, and incumbents in managed access already operate at scale (Clinigen managed access, WEP Clinical EAP). If myTomorrows can convert biopharma partnerships into repeatable workflows and publish decision-grade RWD tied to access programs, the round can shift it from niche facilitator to an embedded part of development and market-access playbooks (myTomorrows services, Avego overview).

The seven diligence questions

Clinical

• How does myTomorrows vet investigational options and triage by evidence strength, safety profile, and inclusion criteria before presenting to physicians, and how are adverse events captured and reported in line with sponsor and regulator rules (FDA Expanded Access, 21 CFR 312 Subpart I)?
• What quality system governs medical review, pharmacovigilance, and protocol adherence across single-patient INDs, cohort EAPs, and EU compassionate-use programs (EMA compassionate use)?

Payer or Access

• In the US and EU, who pays for drug, logistics, and monitoring under expanded-access or named-patient supply, and how is affordability handled when sponsors cannot provide free of charge (MHRA EAMS guidance)?
• How does the platform manage cross-border supply, import licenses, and site compliance, especially when leveraging named-patient pathways versus cohort programs (EMA support for early access)?

Ops or Adoption

• What are current volumes by use case, trial referrals versus EAP activations, time-to-match, and time-to-first-dose, and how do these metrics improve with the new AI features (myTomorrows blog)?
• What share of revenue is recurring from multi-program biopharma contracts, and what is net revenue retention across cohorts and therapy areas?

Competitive

• Where is defensibility versus established managed-access players and distributors, for example Clinigen, Uniphar/Durbin, and WEP Clinical, and is the advantage workflow software, data rights, or network effects (Clinigen managed access, Uniphar access insights, WEP Clinical EAP)?

Team or Cap table

• What governance or board additions follow Avego’s investment, and how does leadership balance growth with the ethical tensions in expanded access highlighted in the literature (Avego firm page, Ethical issues in expanded access)?

Red flags

• Pharma participation is voluntary, supply is finite, and expanded access can divert patients from trials if mismanaged, which would weaken evidence generation and strain sponsor relations (Forbes analysis of Right-to-Try vs Expanded Access, FDA Expanded Access Q&A).
• Cross-border compliance, importation, and pharmacovigilance create operational risk and cost variance by country, especially across EU CUP versus named-patient pathways (EMA compassionate use, EU overview).
• Ethical scrutiny around charging and expectations management in life-threatening disease persists, which can affect reputation and payer optics even when compliant (Ethical issues in expanded access, NEJM/FDA overview).

Next catalyst

Sector event likely to surface new partnerships and metrics: J.P. Morgan Healthcare Conference, San Francisco, 12–15 Jan 2026 (JPM conference page).

FAQ

• What exactly changed by myTomorrows’ “$29 million growth investment” news on 11 Nov 2025, and why does it matter for access and trial recruitment?
  The company announced $29 million from Avego to scale its AI-enabled platform for connecting patients and physicians to trials and expanded access programs, which could accelerate referrals and evidence generation if converted into sponsor deals (Company announcement, Tech Funding News).
• What is the regulatory path after myTomorrows’ 11 Nov 2025 funding, and what are the next formal steps in the US, UK, and EU?
  There is no product approval here, but expanded access activities must follow FDA Subpart I in the US and compassionate-use or named-patient pathways in the EU and UK EAMS processes (FDA guidance, EMA compassionate use, MHRA EAMS overview).
• Which service lines are emphasized by myTomorrows’ 11 Nov 2025 announcement, and how meaningful are they commercially?
  myTomorrows highlights clinical-trial recruitment, end-to-end expanded access program management, and real-world data services that can complement development and access strategies, but commercial impact depends on the depth and renewal of sponsor contracts (myTomorrows services, myTomorrows blog).
• What leadership context is relevant to myTomorrows’ 11 Nov 2025 news?
  The company is led by CEO Michel van Harten, MD, with recent communications positioning AI and evidence as priorities for scaling the platform’s impact on access and enrollment (CEO profile, myTomorrows, Applied Clinical Trials interview).
• How will payers and sponsors treat access after myTomorrows’ 11 Nov 2025 news, and are there codes or pathways involved?
  Payer coverage varies by country and program type, while sponsors decide participation and drug supply; practical pathways include US single-patient INDs and UK EAMS scientific opinions and opinions under existing guidance (FDA guidance, MHRA EAMS guidance).

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 11 Nov 2025, 23:10 London. Purpose: general and impersonal information. Not investment research or advice, no offer or solicitation, no suitability assessment. UK: directed at investment professionals under Article 19(5) and certain high-net-worth entities under Article 49(2)(a)–(d) of the Financial Promotion Order 2005. Others should not act on this. Sources and accuracy: public sources believed reliable, provided “as is,” may change without notice. No duty to update. Past performance is not reliable. Forward-looking statements carry risks. Methodology: questions-first framework using public sources. No conflicts. Authors do not hold positions unless stated. © 2025 LucidQuest Ventures Ltd.

Entities / Keywords

myTomorrows; Avego; expanded access; compassionate use; named-patient supply; EAMS; FDA Subpart I; EMA CHMP; RWD; clinical-trial recruitment; managed access; Clinigen; Uniphar; Durbin; WEP Clinical; oncology; rare disease; single-patient IND; cohort EAP; EU CUP; NPP; MHRA; NICE; NHS England; trial diversity; pharmacovigilance; import license; AI-enabled matching; patient navigation; bio-pharma partnerships

 

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