CER-001 Drug Asset Due Diligence Report 2026

This CER-001 Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 16 September 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Phase 2

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: CONDITIONAL GO

Decision memo

Advance with milestone-based economics while efficacy durability, safety differentiation, patent scope, and market positioning are validated.

The central underwriting question is whether CER-001 can convert its Recombinant protein profile and APOA1 x Phospholipids biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	CER-001 (query alias: CER-001)
Modality / target	Recombinant protein; APOA1 x Phospholipids; APOA1 stimulants, Phospholipids modulators
Highest global status	Phase 2
Originator	Cerenis Therapeutics, Inc.
Active developers	ABIONYX Pharma SA, Academic Medical Center University of Amsterdam, University of Bari

The MCP disease footprint includes Sepsis, Acute kidney injury due to sepsis, Bacterial urinary infection. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
EUCTR2020-004202-60-IT	Phase 2	Not Recruiting	20	Primary endpoint not disclosed in English source
NCT02697136	Phase 3	Terminated	30	Primary endpoint not disclosed in English source
NCT02484378	Phase 2	Completed	301	Primary endpoint not disclosed in English source

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

Phase 3, Multicenter, Randomized, 48 Week, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate Efficacy and Safety of CER-001 on Vessel Wall Area in Patients With Genetically Defined Familial Primary Hypoalphalipoproteinemia

Phase 3; n=30; evaluation: Not stated in English source. Reported fields: Change in Mean Vessel Wall Area (MVWA) of the Carotid Artery(LS Mean) = -0.3 mm^2 (95%CI, -1.0 to 0.4); Change in Mean Vessel Wall Area (MVWA) of the Carotid Artery(LS Mean) = 0.5 mm^2 (95%CI, -0.4 to 1.4)

#1711 Haemophagocytic histiolymphocytis after solid organ transplantation: preliminary data from a cohort study

Not Applicable; n=63; evaluation: Positive. Reported fields: Hyperferritinemia(>1000 µg/L) = 75.0 %

CER-001, an Engineered High-Density Lipoprotein, Shows Beneficial Pleiotropic Effects in Patients with Sepsis in RACERS: A Phase 2A Randomized Control Trial

Phase 2; n=20; evaluation: Positive. Reported fields: SAE = no serious adverse events were attributed to CER-001 use ; SAE = no serious adverse events were attributed to CER-001 use

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

CER-001 addresses Sepsis, Acute kidney injury due to sepsis, Bacterial urinary infection. Commercial attractiveness rests on addressable patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Recombinant protein—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The MCP screen returned 2 matched transaction record(s) under the scope “target-level comparable: APOA1 x Phospholipids.” Partner activity is a market-validation signal, but it does not establish net present value.

5. Transaction precedent and economics

Transaction-scope note: No direct asset-specific transaction was returned. The table below shows target-level comparable: APOA1 x Phospholipids records as comparable precedents only.

Date	Transaction	Phase at deal	Disclosed economics
2009-12-01	The pharmaceutical company and Pfizer have completed a technology transfer plan	Phase 1/2	Financial terms not disclosed
2007-03-29	Avanir Axes Partnerships with Novartis and AstraZeneca as Part of Restructuring Plan	Preclinical	US$10.0M upfront; US$330.0M milestones

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “Lipid binding protein molecule therapy”. The milestone feed surfaced a patent-application signal described as “Methods for treating hyperinflammatory conditions using lipid binding protein -based complexes”. The milestone feed surfaced a patent-application signal described as “Methods for treating acute conditions using lipid binding protein-based complexes”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights.

7. Principal risks and diligence gates

Clinical differentiation versus current standards and pipeline competitors
Safety, dose optimization, and long-term tolerability
Patent scope, territorial rights, manufacturing, and commercial positioning

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

CONDITIONAL GO