At the core of Ceria’s therapeutics is a single, modular active pharmaceutical ingredient (API): CNP-miR146a.

• The payload – miR-146a oligomimetic
  miR-146a is a naturally occurring microRNA that acts as a brake on the body’s acute inflammatory response. It binds to messenger RNAs for IRAK1 and TRAF6, two key upstream activators of the TLR4 / NF-κB pathway. By targeting these for degradation, miR-146a turns down NF-κB signaling and reduces the cascade of inflammatory cytokines (like TNF-α, IL-6) that drive tissue damage.

• The delivery vehicle – cerium oxide nanoparticles (CNPs)
  The miR-146a mimic is bound to solid cerium oxide nanoparticles, which are bioinert, low-cost, and specifically engineered to protect the RNA from degradation and deliver multiple copies efficiently into target cells. This is particularly i

CTX-001 is an intradermal injectable formulation of CNP-miR146a for patients with moderate-to-severe diabetic foot ulcers (DFU) and advanced pressure ulcers (PU)—wounds that are often refractory to standard care and drive amputations, long stays, and unreimbursed costs.

• Clinical problem addressed

  • DFUs and advanced PUs are characterized by chronic inflammation, oxidative stress, poor angiogenesis, and delayed healing.

  • Standard care (offloading, debridement, dressings, topical agents) often fails to fully close these wounds, leading to infection, sepsis, surgery, and major cost exposure for facilities and payers.

• How CTX-001 works in wounds
  Injected into the periphery and bed of the ulcer, CTX-001 is designed to:

  • Suppress excessive inflammatory signaling in local macrophages

  • Reduce oxidative stress and inflammatory infiltrates

  • Promote angiogenesis and collagen deposition, restoring tissue structure and vascularity

• What’s been seen preclinically
  In diabetic mouse and pig models:

  • CTX-001 and its topical counterpart accelerate wound closure versus controls and legacy agents (e.g., Regranex, Granexin)

  • Improve quality of healing (collagen architecture, vascularization)

  • Show a favorable safety profile even at suprapharmacologic doses

• Why it’s unique and valuable

  • Targets the biology driving non-healing, rather than just managing moisture or infection

  • Addresses both DFU and PU with one core API and related formulations

  • Fits existing wound-care workflows in clinics, SNFs, and hospitals with administration by trained providers

CTX-002 is an aerosolized formulation of CNP-miR146a for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS)—a spectrum of ICU conditions with high mortality and no approved disease-modifying drugs.

• Clinical problem addressed

  • ALI/ARDS account for ~10% of ICU admissions globally and carry 40–70% mortality in severe cases.

  • Regardless of cause (infection, sepsis, trauma, inhaled toxins), patients develop massive inflammatory cytokine release, pulmonary edema, and impaired gas exchange.

  • Current care is largely supportive: ventilation, sedation, proning, ECMO. These are expensive and can themselves worsen lung injury.

• How CTX-002 is used

  • Soft-mist inhaler for ALI and acute respiratory failure in conscious patients (ED / floor / step-down settings)

  • Nebulized delivery in ICU patients with ARDS, with or without mechanical ventilation

• What’s been seen preclinically
  Across multiple ALI/ARDS models (LPS, VILI, MRSA, bleomycin, sulfur mustard):

  • Rapid reduction in lung inflammation and edema

  • Improved oxygenation and lung function

  • Prevention of progression from ALI to ARDS when given early

  • Meaningful mortality reductions in lethal exposure models

• Why it’s unique and valuable

  • One of the few programs aiming to be a true disease-modifying therapy in ARDS/ALI, not just supportive care

  • Fits directly into existing ED and ICU workflows as an add-on inhaled or nebulized therapy

  • Serves both acute treatment and post-insult rescue windows, widening its clinical utility

Our first-in-class products incorporate CNP-miR146a, a miRNA-146a conjugated to CNP. This novel molecule allows for highly efficient delivery of miRNA-146a to suppress the acute inflammatory pathway. By delivering CNP-miR146a directly to the site of inflammation, we restore balance to the inflammatory response and halt disease progression.

Because all assets share the CNP-miR146a API, Ceria can extend its platform efficiently into multiple high-value indications:

• CTX-003 – Oral RNA Therapeutic for Inflammatory Bowel Disease (IBD)

  • Oral formulations for ulcerative colitis and Crohn’s disease

  • Preclinical work shows that CNP binding protects miR-146a through stomach acid and intestinal enzymes, overcoming a long-standing barrier in RNA therapeutics.

  • In colitis models, oral and enema delivery reduced histologic inflammation, normalized cytokines, and corrected Th1/Th17 skewing.

  • Designed for flare-based dosing, potentially reducing reliance on chronic systemic immunosuppressants.

• CTX-004 – Topical Therapeutic for Mild-to-Moderate DFU

  • A self-administered topical RNA therapeutic for earlier-stage diabetic wounds (Grade 0-1).

  • Extends the DFU franchise “upstream” of CTX-001 to address patients before ulcers become advanced, invasive, and expensive.

• CTX-006 – IV Therapy for Acute Kidney Injury (AKI)

  • Intravenous CNP-miR146a for AKI in critical care settings.

  • Designed to reduce renal inflammation and downstream fibrosis in a condition with no disease-modifying drugs and billions in excess hospital spend.

• CTX-007 – IV Therapy for Sepsis

  • Intravenous formulation for toxemic sepsis, targeting the overwhelming systemic inflammatory response that drives organ failure.

  • Aligns directly with ICU and ED treatment pathways where the unmet need and economic burden are highest.

Ceria’s therapeutic franchise is built to be scientifically coherent, operationally efficient, and capital-leveraged:

• One core API, many indications

  • CNP-miR146a underpins all major assets (CTX-001 through CTX-007).

  • This allows shared CMC, analytics, toxicology learnings, and regulatory experience, lowering overall platform risk compared with a “collection of unrelated drugs.”

• Differentiated RNA delivery

  • CNP-based delivery has shown the ability to protect RNA in hostile environments (GI, inflamed tissue, lungs) where conventional RNA would fail.

  • The platform’s low-cost, solid nanoparticle chemistry is designed to undercut typical RNA manufacturing expense, enabling better gross margins and pricing flexibility.

• In-house manufacturing & Puerto Rico leverage

  • Ceria is building internal GMP capacity for its RNA nanoparticles in Puerto Rico, maintaining control of proprietary process know-how and avoiding risky tech transfer.

  • Act-60 incentives and R&D tax credits provide access to tens of millions in matching, non-dilutive capital, effectively amplifying investor dollars and de-risking long-term COGS.

• De-risking via non-dilutive funding & diversified shots on goal

  • The platform has already attracted substantial federal grant support, including DoD and public-health–aligned awards.

  • Seven assets across three therapeutic areas mean multiple independent paths to value creation—through licensing, co-development, asset sales, or a future corporate exit.

• Compelling value proposition to healthcare administrators

  • Targets conditions that drive ICU bed utilization, readmissions, amputations, and unreimbursed “never event” costs.

  • Designed to fit into existing care pathways (wound clinics, EDs, ICUs, GI practices) with interventions that can be measured on both clinical outcomes and cost avoidance.