Clinician administering treatment to a patient in a hospital room
FDA Breakthrough Therapy · Fast Track · Orphan Drug*

Enhance tumor response,
reduce side effects.

Every year, 1.8 million patients1 receive radiation meant to kill their cancer — yet treatment is often limited by damage to the healthy tissue around it. BMX-001 is designed to change the equation: enhancing tumor response to radiation and chemotherapy while reducing side effects.

BMX-001 is an investigational product. BioMimetix has no product approved by the FDA or any other regulatory authority. View full disclaimers.

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Patients Treated Across Programs
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Reduction in Severe Oral Mucositis · Phase 2 H&N
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Median OS Gain in Glioma
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Global Commercial Opportunity
Potential to Enhance Tumor Response
Preclinical studies demonstrate sensitization of cancer cells to radiation and chemotherapy through redox modulation of pathways including NF-κB and HIF-1α.
Designed to Shield Healthy Tissue2
A SOD-mimetic shown to reduce chemoradiation injury in normal tissue — protecting the patient during treatment.
Clinical Validation

Validated with clinical evidence.
Regulatory recognition.

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Patients Treated Across All Programs
Positive clinical experience across Phase 1 and randomized Phase 2 studies.24
Clinical safety and effectiveness data
Breakthrough* · Fast Track* · Orphan*
FDA Regulatory Designations

* Breakthrough Therapy, Fast Track, and Orphan Drug designations all apply to the glioma indication only.

Clinician caring for a patient during treatment
The Human Impact

Behind every data point, a patient.

BMX-001 is measured not only in early clinical data, but in the potential for patients to better tolerate treatment, maintain full dosing, and live longer.

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Median Overall Survival Gain (Glioma)
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Patients Treated Across Programs
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Fewer Severe Oral Mucositis Episodes
Universal Applicability

One mechanism.
Every solid tumor.

BMX-001 does not target a single cancer. It modulates the redox biology that radiation itself exploits — sensitizing tumors while protecting the normal tissue radiation harms. Because roughly 90% of cancers are solid tumors1 and about half of all cancer patients receive radiation therapy10, that mechanism has the potential to reach across nearly the entire solid-tumor landscape.

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of cancers are solid tumors — and radiation is a mainstay of treatment for the majority of them. A drug that improves what radiation does could change the standard of care broadly, not narrowly.

Sensitizes Tumors

Inhibits HIF-1α to weaken tumor defenses against radiation — a mechanism shared by virtually all irradiated solid tumors, not one histology.

Protects Normal Tissue

Inhibits NF-κB to shield healthy tissue from radiation injury — potentially widening the therapeutic window wherever radiation is used.

Indication-Agnostic by Design

Because the mechanism is tied to radiation biology rather than a specific cancer type, the platform has potential applicability across the solid-tumor landscape.

See the pipelineSix active programs
Where Radiation Is Used
BrainHead & NeckLungBreastProstateColorectalAnalGynecologicPancreaticEsophageal

Broad applicability is a potential based on mechanism and the central role of radiation in solid-tumor care; it must be confirmed in clinical studies for each individual indication.

Platform Potential

The neurology pipeline.
A platform built for the brain.

BMX-001's redox-active mechanism is a natural fit for neuro-oncology — with the potential to enhance tumor kill while protecting cognition and white matter that radiation threatens. Clinical findings in glioma support this; the pipeline ahead extends it4.

Observed in Randomized Phase 2 High Grade Glioma Trial
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Median Overall Survival Gain
Observed in Randomized Phase 2 High Grade Glioma Trial
Cognition Preserved4
Positive neurocognitive trend vs. SOC
Observed in Randomized Phase 2 High Grade Glioma Trial
White Matter Protection Trend4
Exploratory diffusion tensor imaging in a small patient subset
Future Neurology Pipeline

Brain Metastases

Whole-brain radiation neuroprotection — preserving cognition in the ~200K U.S. patients treated annually.

Pediatric CNS Tumors

Reducing long-term neurocognitive injury in children receiving cranial radiation — where late effects matter most.

Radiation Neuroprotection

Shielding healthy brain tissue from radiation-induced cognitive decline — a major unmet need with no approved therapy.

Next-Gen MnP Compounds

BMX-201 / BMX-202 designed with the goal of improved CNS penetration and tuned redox activity.

Beyond the Current Pipeline

Beyond its current oncology programs, BioMimetix sees potential to apply its redox platform to CNS and other diseases driven by oxidative stress and inflammation.56789

A Natural Fit for the Brain

The brain is particularly vulnerable to oxidative stress. BMX-001's SOD-mimetic redox activity targets reactive oxygen species and downstream inflammatory signaling — mechanisms relevant to both treatment-related CNS injury and broader neurologic disease.

Indication-Agnostic Scaffold

The redox-active manganese porphyrin platform is tunable — extendable to neuroinflammation, ischemia-reperfusion, and other oxidative-stress-driven pathologies beyond oncology.

Regulatory Experience

FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations in high-grade glioma provide BioMimetix with regulatory experience that can inform development of BMX-001 and future candidates in additional CNS indications.

Academic Collaborations

Developed through leading academic and cooperative-group collaborations

BMX-001 has advanced through collaborations with leading academic medical centers, NCI-supported research programs, and national cooperative trial groups — from early development and federal research funding to multi-institutional clinical trials11.

Major Universities & Academic Medical Centers

Founders, KOLs, and trial sites drawn from the nation's leading research institutions.

Duke University
National Jewish Health
UCSF
University of Nebraska Medical Center
NIH / NCINIH / NCI

NIH / NCI11

Peer-reviewed federal grant funding supports the platform, including the NCI-funded expansion of BMX-001 into colorectal carcinoma.

BioMimetix

A clinical-stage oncology company developing BMX-001, a first-in-class manganese porphyrin. Preclinically, BMX-001 enhances tumor response to radiation and chemotherapy while protecting normal tissue; clinically, it has demonstrated encouraging survival, normal-tissue protection, tolerability, and function across clinical programs.

© 2026 BioMimetix, Inc. All rights reserved.

Non-Confidential

BMX-001 is an investigational product candidate and is not approved by the FDA, EMA, or any other regulatory authority. Information on this website includes forward-looking statements and is provided for informational purposes only. See Legal & Disclaimers.