Acquisition intelligence · WATCH

poziotinib

NSCLC

Registry context is not proof of global abandonment, clinical benefit or availability.

Human Signal

UNKNOWNConfidence UNKNOWN

Drivers and unknowns

Human Efficacy: UNKNOWN
Not assessed

Exposure: UNKNOWN
Not assessed

Target Engagement: UNKNOWN
Not assessed

Indication Relevance: UNKNOWN
Not assessed

Contradictory Evidence: UNKNOWN
Not assessed

Cheap Truth

UNKNOWNConfidence UNKNOWN

Drivers and unknowns

Patient Access: UNKNOWN
Not assessed

Objective Endpoint: UNKNOWN
Not assessed

Endpoint Duration: UNKNOWN
Not assessed

Sample Burden: UNKNOWN
Not assessed

Dosing Monitoring: UNKNOWN
Not assessed

Sites Procedures: UNKNOWN
Not assessed

Acquirability

UNKNOWNConfidence UNKNOWN

Drivers and unknowns

Current Holder: UNKNOWN
Not assessed

Chain Of Title: UNKNOWN
Not assessed

Ip Runway: UNKNOWN
Not assessed

Data Transfer: UNKNOWN
Not assessed

Cmc Transfer: UNKNOWN
Not assessed

Seller Motivation: UNKNOWN
Not assessed

RescueabilityUNKNOWN

Why strandedCORPORATE/STRATEGIC FAILURE / FINANCING FAILURE / RECRUITMENT/EXECUTION FAILURE / SAFETY FAILURE

Current controlUNKNOWN

Why nowUNKNOWN — no current sourced catalyst established

Likely restartUNKNOWN — scoped data/regulatory review needed

Capital to next truthUNKNOWN

Time to next truthUNKNOWN

Next decisive questionCan asset-specific human findings and transferable data support a credible next decision?

MODEL INFERENCE Principal risk: Public summaries may not translate into transferable, decision-quality evidence for the proposed product.

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01 · Decision framing

Executive Thesis

MODEL INFERENCE

Resolve evidence transferability before committing to development; this is diligence triage, not a purchase recommendation.

Resolve explicit concerns and missing evidence before prioritizing capital.

Confidence UNKNOWN. Unknown inputs remain unresolved; this is a diligence lead, not a buy recommendation.

Why It Stopped

MODEL INFERENCE

Cannot determine · Non-biological stopping reasons warrant review only if separate human evidence remains plausible; they do not prove the drug works.

Business decision, not related to safety.

SOURCE FACT NCT04402008 · 2024-06-25 · trial-scoped stopping reason

Strategic business decision (unrelated to safety)

SOURCE FACT NCT04172597 · 2024-03-13 · trial-scoped stopping reason

Low recruitment

SOURCE FACT NCT01819428 · 2016-03-01 · trial-scoped stopping reason

Dose limiting toxicity

SOURCE FACT NCT03429101 · 2021-01-15 · trial-scoped stopping reason

COVID

SOURCE FACT NCT03804515 · 2021-06-15 · trial-scoped stopping reason

Strategic business decision (unrelated to safety)

SOURCE FACT NCT03318939 · 2026-06-12 · trial-scoped stopping reason

\<75% participation

SOURCE FACT NCT03066206 · 2026-02-20 · trial-scoped stopping reason

Study closed due to funding, 0 patient accrual.

SOURCE FACT NCT05045404 · 2023-09-13 · trial-scoped stopping reason

The study has not enrolled any patients. The study design is under discussion and will likely be redesigned in consultation with the FDA.

SOURCE FACT NCT05378763 · 2026-09-01 · trial-scoped stopping reason

Business reasons, not related to safety.

SOURCE FACT NCT03744715 · 2026-07-28 · trial-scoped stopping reason

Study termination by the Sponsor

SOURCE FACT NCT04044170 · 2020-11-17 · trial-scoped stopping reason

Human Evidence

Publication existence does not establish benefit or safety. Treatment relationship, human context, indication and endpoint relevance must all be checked.

SOURCE FACT Consensus for HER2 alterations testing in non-small-cell lung cancer.

PMID 35149428 · 2022-Feb. MODEL INFERENCE Human context: False. Eligible for diligence: False.

SOURCE FACT Targeted Therapies for EGFR Exon 20 Insertion Mutation in Non-Small-Cell Lung Cancer.

PMID 38892105 · 2024-May-29. MODEL INFERENCE Human context: False. Eligible for diligence: False.

SOURCE FACT Mechanisms and clinical activity of an EGFR and HER2 exon 20-selective kinase inhibitor in non-small cell lung cancer.

PMID 29686424 · 2018-May. MODEL INFERENCE Human context: True. Eligible for diligence: False.

SOURCE FACT Pan-Cancer Landscape and Analysis of ERBB2 Mutations Identifies Poziotinib as a Clinically Active Inhibitor and Enhancer of T-DM1 Activity.

PMID 31588020 · 2019-Oct-14. MODEL INFERENCE Human context: True. Eligible for diligence: False.

SOURCE FACT Targeted Therapy in HER2 Exon 20-Mutant Non-small Cell Lung Cancer With Leptomeningeal Disease: A Case-Based Approach to Treatment Decision-Making.

PMID 40727063 · 2025-Jul. MODEL INFERENCE Human context: False. Eligible for diligence: False.

Inspect original evidence and attribution records

What Prior Work Still Counts

SOURCE FACT 24 cached trial contexts, which may include comparator, combination or other indication use.

UNKNOWN Raw-data transferability, product equivalence and accepted reuse require scoped review. Trial completion alone does not establish reusable development.

Subscription access opens scoped analysis tools; it does not resolve missing evidence, prove ownership or guarantee a usable budget.

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Development Restart

Where the asset responsibly restarts depends on the exact product, indication, reusable package and regulator position.

Scoped analysis requires subscription access. Missing evidence remains UNKNOWN. View access options

Cost-to-Truth

The next dollar should buy a decision. A useful budget defines the question, decisive endpoint, operational burden and stop/go criteria.

Scoped analysis requires subscription access. Missing evidence remains UNKNOWN. View access options

Rights / Acquisition Path

UNKNOWN

Current legal clearance is UNKNOWN. Sponsor is not owner; patent assignee is not automatically commercial controller. A corporate acquisition does not establish asset title.

Scoped analysis requires subscription access. Missing evidence remains UNKNOWN. View access options

Transaction Economics

Historical development spend is sunk cost, not an acquisition valuation.

Scoped analysis requires subscription access. Missing evidence remains UNKNOWN. View access options

Competing Interest

UNKNOWN

No comprehensive current competing-interest review is established. Absence of a stored signal does not mean absence of buyers.

Walk-Away Conditions

MODEL INFERENCE

No usable or transferable data rights
Unresolved material safety signal
Unbridgeable product or manufacturing change

What Would Change Our Mind

MODEL INFERENCE

Transferable source data, a documented current rights path and a feasible decisive experiment could justify further diligence. Material safety, title or feasibility failures could end it.

Sources

SOURCE FACT

Cached source dates are not confirmation that a historical claim remains current. Source conflicts: 0. Confidence and scope stay attached to the evidence.

Registry records and source dates

NCT02979821 · COMPLETED · 2018-05-24 · HER2 Gene Mutation; Adenocarcinoma Lung Stage IV

NCT01718847 · COMPLETED · 2015-08-14 · Increased Drug Resistance

NCT04402008 · TERMINATED · 2024-06-25 · NSCLC

NCT02544997 · COMPLETED · 2020-07-07 · Metastatic Breast Cancer

NCT04172597 · TERMINATED · 2024-03-13 · Breast Cancer; Colorectal Cancer; Solid Tumor; Glioblastome Multiforme

NCT01819428 · TERMINATED · 2016-03-01 · Adenocarcinoma of Lung Stage IIIB; Adenocarcinoma of Lung Stage IV

NCT03429101 · TERMINATED · 2021-01-15 · Breast Cancer

NCT03804515 · TERMINATED · 2021-06-15 · Solid Tumor

NCT02418689 · COMPLETED · 2022-01-20 · Metastatic Breast Cancer

NCT01455584 · COMPLETED · 2013-05-23 · Advanced Solid Malignancies

NCT04981704 · COMPLETED · 2021-09-05 · Healthy

NCT04436562 · COMPLETED · 2021-01-15 · Healthy

NCT02216916 · UNKNOWN · 2019-03-18 · HNSCC

NCT02659514 · COMPLETED · 2022-03-11 · Breast Cancer

NCT03318939 · TERMINATED · 2026-06-12 · NSCLC

NCT01455571 · COMPLETED · 2014-02-26 · Advanced Solid Tumor

NCT03066206 · TERMINATED · 2026-02-20 · EGFR Exon 20 Mutation; ERBB2 Gene Mutation; Recurrent Lung Non-Small Cell Carcinoma; Stage IV Non-Small Cell Lung Cancer AJCC v7

NCT03292250 · COMPLETED · 2022-03-29 · HNSCC; Head and Neck Neoplasms

NCT05045404 · WITHDRAWN · 2023-09-13 · Metastatic Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8

NCT03770988 · UNKNOWN · 2019-02-22 · Inoperable or Recurrent or Metastatic Esophageal Squamous Carcinoma

NCT05378763 · SUSPENDED · 2026-09-01 · NSCLC

NCT03744715 · TERMINATED · 2026-07-28 · NSCLC; Breast Cancer

NCT01746771 · COMPLETED · 2016-03-03 · HER-2 Positive Advanced Gastric Cancer

NCT04044170 · TERMINATED · 2020-11-17 · NSCLC

Understand the methodology and limitations

Why this survived

MODEL INFERENCE: a source-backed stopping observation deserves review; it has not necessarily passed buyer qualification.

Next Best Diligence Question

Resolve the first unassessed or concerning gate component before capital allocation.

Why it matters: this gap can change whether further work is justified. Seek scoped human outcomes and transferable rights/data from official registry results, publications and executed agreements. The decision may remain UNKNOWN.

Evidence completeness — not confidence

Human Signal: 0 / 5 components adjudicated

Cheap Truth: 0 / 6 components adjudicated

Clean Rights: 0 / 6 components adjudicated

Market Pull: 0 / 5 components adjudicated

Fatal flaw

Unknown — absence of a fatal rating is not safety clearance.

See the scoped failure evidence and principal risks above.

What would change our mind?

DILIGENCE CRITERIA: attributable benefit, transferable rights and a feasible next study would increase conviction; adequate negative results, material safety harm or inaccessible essential rights would weaken it. These are questions, not observed facts.