Lucid Diligence Brief: Wa’ed Ventures Kure Cells pre-Series A

Timos Papagatsias

2 weeks ago

Lucid Diligence Brief: Wa’ed Ventures Kure Cells pre-Series A

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

Wa’ed Ventures disclosed on 23 Oct 2025 that it led a $10 million pre-Series A round in Kure Cells, a US cell-therapy platform company focused on ultra-fast CAR-T manufacturing (Wamda). Kure posted the same day that coinvestors included NantBio, Qomel, and “US93” (Kure Cells news post). Qomel separately announced a SAR 5.2 million, about $1.38 million, commitment on 13 Oct 2025, corroborating participation (Argaam disclosure).

60-second thesis frame

Signal says this is a strategic bridge around two claims, same-day CAR-T manufacturing and momentum toward regulatory acceleration. UF-Kure19 has phase 1 results presented at ASH 2024, reported at an 80 percent complete response rate with low toxicity in relapsed or refractory NHL, which is directionally supportive but early and single-arm (OncLive summary, ASH abstract in Blood supplement, ClinicalTrials.gov NCT05400109). Wamda cites an 88 percent complete response figure, higher than oncology trade coverage, so diligence should privilege curated ASH data over media recaps (Wamda). The platform’s cost and time claims are notable, with Case Western describing sub-24-hour manufacturing and roughly $10,000 product cost per infusion, but these are institutional statements, not payer-validated economics (Case Western “Accelerating Immunotherapy”, CWRU news note). Kure says UF-Kure19 received FDA RMAT designation, which could compress timelines, but FDA does not maintain a comprehensive public RMAT list, so verification requires the agency letter (Kure RMAT post, FDA RMAT program page, FDA draft guidance on RMAT, Sep 2025). Upside is speed, lower COGS, and Saudi localization, but risks include durability versus approved CD19 CAR-Ts, manufacturing reproducibility at scale, coding and reimbursement, and an arms race across ex vivo automation and in vivo CAR-T entrants (Reuters on BMS–Cellares $380m deal, Reuters on Kite–Interius in vivo platform).

The seven diligence questions

Clinical

What is UF-Kure19’s durability beyond 6–12 months versus approved CD19 CAR-Ts on relapse-free survival and retreatment, across LBCL and FL cohorts (OncLive summary, ClinicalTrials.gov NCT05400109).
How do grade 3+ CRS and ICANS rates compare to class norms with ultra-fast manufacturing, and do bridging therapies confound outcomes (ASH abstract in Blood supplement).

Payer or Access

If manufacturing cost is “about $10,000,” how do total episode costs land under MS-DRG 018 and existing Q-code pricing, and will any savings accrue to payers or sites (Case Western “Accelerating Immunotherapy”, CMS MLN FY26 IPPS update referencing MS-DRG 018, Avalere payer brief on CAR-T reimbursement, Sep 2025).
What is the path to HCPCS coding, and who bears risk for manufacturing failures or out-of-spec product under current Medicare policies (CMS transmittal replacing 0540T with 38228, Jul 2025, ASTCT CAR-T Coding and Billing Guide).

Ops or Adoption

Can Kure reproducibly achieve sub-24-hour release with GMP comparability across US and Saudi sites, including vector supply, sterility and rapid-release testing, within SFDA expectations for cell-based trial CMC (SFDA CMC guidance for cell-based clinical trial applications, istitlaa portal summary).

Competitive

Against automated ex vivo platforms and capacity deals, what is Kure’s defensibility on process IP and clinical outcomes, and how do in vivo CAR-T approaches alter the adoption curve (Reuters on BMS–Cellares $380m deal, Kite/Interius acquisition, Reuters).

Team or Cap table

As the 23 Oct 2025 lead, what governance and economic terms did Wa’ed obtain, board or observer seat, protective provisions, pro rata, liquidation preference or participation, anti-dilution, option pool refresh, and how do these interact with any SAFEs or notes on a fully diluted basis? (Wamda, Kure Cells news post, NVCA Model Term Sheet, Cooley GO SAFE primer).

Red flags

RMAT status is company-reported, not confirmed on an FDA public list; require the FDA designation letter and meeting minutes (Kure RMAT post, FDA RMAT program page).
Efficacy discrepancy, 88 percent CR in media versus 80 percent in ASH-anchored coverage; prioritize curated ASH data until peer-reviewed publication (Wamda, OncLive summary, ASH abstract).
Saudi localization adds regulatory and GMP complexity; SFDA expects robust CMC comparability for process changes, which can slow tech transfer (SFDA CMC guidance, istitlaa portal summary).

Next catalyst

ASH Annual Meeting, Orlando, 6–9 Dec 2025, potential UF-Kure19 update or pipeline disclosures (ASH Annual Meeting page, Schedule and Program).

FAQ

What exactly changed by Wa’ed Ventures’ “$10 million pre-Series A” news on 23 Oct 2025, and why does it matter for cell-therapy manufacturing?
Wa’ed Ventures led a $10 million round into Kure Cells, which is developing same-day CAR-T manufacturing, with coinvestors including Qomel and others, signaling strategic capital plus potential Saudi localization (Wamda, Kure Cells news post, Argaam disclosure).
What is the regulatory path after this funding, and what are the next formal steps in the US and Saudi Arabia?
Kure cites FDA RMAT designation for UF-Kure19, which, if validated, enables intensive FDA engagement and potential rolling submissions, but verification requires the agency letter since FDA does not keep a comprehensive public RMAT list (Kure RMAT post, FDA RMAT program page). In Saudi Arabia, SFDA’s cell-based CMC guidance outlines comparability and labeling expectations that would govern local trials and manufacturing (SFDA CMC guidance).
Which endpoints in UF-Kure19 drove the result cited in the 23 Oct 2025 coverage, and how meaningful was the effect size?
ASH 2024 presentations report about 80 percent CR in relapsed or refractory NHL with low toxicity in a single-arm phase 1; Wamda later quoted 88 percent CR. Effect sizes need confirmation in larger, controlled cohorts and over longer follow-up (OncLive summary, ASH abstract, Wamda).
What safety issues matter post-announcement, and do they change real-world use?
Key concerns remain grade 3+ CRS and ICANS and whether ultra-fast manufacturing changes risk profiles relative to class experience; available phase 1 data suggest low toxicity, but sample sizes are small (OncLive summary, ASH abstract).
How will major US payers treat access after this funding, including prior auth, codes and site-of-care questions?
For CY/FY 2025, inpatient episodes map to MS-DRG 018 and outpatient administration uses CPT 38228, which replaced 0540T on Jan 1, 2025; product HCPCS Q-codes apply by brand, and policies vary by payer (CMS transmittal replacing 0540T with 38228, ASTCT CAR-T Coding and Billing Guide, CMS MLN FY26 IPPS update referencing MS-DRG 018).

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 23 Oct 2025, 20:27 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

Kure Cells; UF-Kure19; Wa’ed Ventures; Saudi Aramco; Qomel; NantBio; US93; RMAT; FDA CBER; SFDA; ASH 2024; ASH 2025; CAR-T; CD19; LBCL; FL; NCT05400109; MS-DRG 018; Q2041–Q2056; CPT 38225–38228; Cellares; Bristol Myers Squibb; Kite Pharma; Interius; Case Western Reserve University; ultrafast manufacturing; Saudi localization; ATMP; cell therapy reimbursement; OPPS; capacity reservation; in vivo CAR-T.

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