Investor Relations · NASDAQ: KHLB
Building a category-defining precision medicine platform.
Institutional disclosures, pipeline status, and platform fundamentals for shareholders, analysts, and prospective investors in Kihealth Labs.
01 / Technology Platform
One molecular substrate. Many disease programs.
InterceptIQ™ unifies ultra-deep cell-free DNA sequencing, fragmentomic inference, and a 47-cell-type tissue-of-origin atlas under a single federated training and analytics architecture — supporting six clinical programs from one technical substrate.
Ultra-deep cfDNA sequencing
Whole-genome bisulfite sequencing at 30× depth with proprietary fragmentomic inference.
Tissue-of-origin atlas
47-cell-type methylation atlas trained on > 4,200 normal and disease samples.
Federated learning network
Models trained across nine academic medical centers without moving patient data.
CLIA / CAP laboratory
ISO 15189 high-complexity laboratory with 180,000-sample annual capacity.
Market opportunity
Four diseases. One molecular substrate. A multi-segment TAM.
Each indication shares a common diagnostic gap — and a common solution architecture — addressable by the InterceptIQ™ platform.
Combined US annual cost
US patients across indications
Diagnostic TAM (global)
Validated cfDNA tests today
Type 1 Diabetes
T1D · Disease interception target
No direct measurement of beta-cell death.
64K new US dx / year
Direct medical only
Diagnosis relies on hyperglycemia — by which point >80% of beta-cell mass is lost. No biomarker exists to stage autoimmune progression or monitor immunotherapy response in real time.
Sources: CDC, ADA, NIH SEER, Alzheimer's Association, IDF Diabetes Atlas (2023–2024). Bar values normalized for visual comparison; underlying figures shown at right.
03 / Pipeline
Six programs in active clinical development.
Branded by indication and developed under prospective IRB protocols designed for regulatory and payer evidence. Phase position shown is at the program's most advanced indication.
| Program | Indication | Phase | Next milestone |
|---|---|---|---|
BetaIntercept™ T1 Pivotal | Type 1 Diabetes | DiscoveryValidationPhase IIPivotalFiled | Topline H2 2026 |
BetaIntercept™ T2 Phase II | Type 2 Diabetes (high-risk) | DiscoveryValidationPhase IIPivotalFiled | Interim Q4 2026 |
OncoIntercept™ MRD Phase II | Pancreatic adenocarcinoma | DiscoveryValidationPhase IIPivotalFiled | ASCO 2027 |
OncoIntercept™ MCED Validation | Multi-cancer early detection | DiscoveryValidationPhase IIPivotalFiled | First study Q1 2027 |
NeuroIntercept™ AD Discovery | Alzheimer's disease | DiscoveryValidationPhase IIPivotalFiled | IND-enabling 2027 |
InterceptIQ™ RX Pharma partnered | Therapeutic monitoring (CDx) | DiscoveryValidationPhase IIPivotalFiled | 2 readouts 2026 |
04 / Clinical Validation
Evidence-grade by design.
Every program is co-developed with academic medical centers under IRB-approved protocols. Analytical and clinical validation packages are constructed from study inception to support FDA submission and payer coverage.
05 / Intellectual Property
Layered, defensible IP estate.
Composition-of-matter, method-of-use, and platform-AI patents across cfDNA methylation, fragmentomic inference, tissue-of-origin deconvolution, and federated training.
| Patent family | Granted | Pending | Jurisdictions |
|---|---|---|---|
| Methylation cfDNA composition | 7 | 12 | US, EU, JP, CN, AU, UK |
| Fragmentomic inference (method) | 4 | 9 | US, EU, JP, CN |
| Tissue-of-origin atlas | 3 | 6 | US, EU, JP |
| Federated training architecture | 2 | 5 | US, EU |
| Assay chemistry & workflows | 5 | 8 | US, EU, JP, CN, IN |
| Total estate | 21 | 40 | 8 jurisdictions worldwide |
06 / Milestones & Roadmap
A staged path from platform to commercial launch.
- 2024Q4Platform validatedCompleted
InterceptIQ™ analytical validation locked; BetaIntercept™ T1 first patient enrolled.
- 2025Q3Breakthrough DeviceCompleted
OncoIntercept™ MRD granted FDA Breakthrough Device designation. Series C closed at $240M.
- 2026Q2TodayNow
BetaIntercept™ T2 interim safety and biomarker analysis. Pharma CDx expansion.
- 2026Q4Pivotal readoutUpcoming
BetaIntercept™ T1 topline readout from INTERCEPT-T1D pivotal study.
- 2027Q2First FDA submissionUpcoming
BetaIntercept™ T1 PMA submission. OncoIntercept™ MRD interim at ASCO.
- 2028Q1Commercial launchUpcoming
BetaIntercept™ T1 US launch. NeuroIntercept™ pivotal study initiation.
07 / Strategic Partnerships
Pharma, health-system, and academic reach.
Companion-diagnostic and therapeutic-monitoring engagements with global pharma; population-health programs with integrated delivery networks; and translational collaborations with leading academic centers.
08 / Filings & Events
Latest disclosures and upcoming engagements.
SEC Filings & Press
View archiveUpcoming events
Analyst coverage
- Goldman SachsBuy · $58
- Morgan StanleyOverweight · $52
- CowenOutperform · $55
- Wells FargoEqual Weight · $44
Investor Relations
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Forward-looking statements: this page contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially.