BPGbio is a biology-first, AI-powered, clinical-stage biopharmaceutical company focused on mitochondrial biology and protein homeostasis. The company integrates Bayesian causal artificial intelligence with experimental biology to accelerate drug discovery and development in oncology, rare diseases, and neurology. Its core technology, the proprietary NAi Interrogative Biology™ Platform, enables the identification of therapeutic targets, biomarkers, and drug candidates based on unbiased multi-omic data from human patients.

Corporate Overview

Headquartered in the Boston metropolitan area, BPGbio unites biology, multi-modal data, and AI to advance clinical and diagnostic programs aimed at understanding, detecting, and treating human diseases. The company acquired key assets from Berg, LLC and obtained the rights to use the Berg and Berg Health trademarks.

The NAi Platform applies Bayesian causal AI to clinically annotated, unbiased patient samples, analyzing billions of data points to reveal disease mechanisms and actionable biological relationships. This enables the simultaneous generation of target hypotheses and companion biomarkers from the same data streams, improving the predictive accuracy of translational research and reducing clinical risk.

Key technological features include:

• Access to high-performance computing at the Oak Ridge National Laboratory Frontier supercomputer
• A large external biobank with longitudinal and clinically annotated samples
• Spatial mass spectrometry imaging and other advanced analytics
• A robust intellectual property portfolio

The NAi platform supports the full R&D continuum—from target discovery and molecule design to clinical trial design—providing a scalable decision-making infrastructure for biopharma research.

BPGbio employs multi-omic data derived from tissue, blood, and urine samples collected in Phase I studies to analyze mechanisms of action and safety profiles at the patient-subgroup level. This approach improves pharmacodynamic biomarker discovery, patient stratification, and clinical protocol design to reduce adverse event risk.

BPM31510, the company’s lead program, is a mitochondrial metabolism modulator developed in multiple pharmaceutical forms:

• Topical formulation: Completed early studies in epidermolysis bullosa and cutaneous squamous cell carcinoma
• Intravenous formulation: Advanced to Phase II trials in glioblastoma and pancreatic cancer
• Oral formulation: Completed Phase I trials for sarcopenia
• Coenzyme Q10 deficiency: Under late-stage evaluation

The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to BPM31510 for Primary Coenzyme Q10 Deficiency and Epidermolysis Bullosa, making it eligible for a Priority Review Voucher upon approval.

Discovery Programs

Leveraging NAi’s large-scale datasets, BPGbio identified a class of ubiquitin-conjugating (E2) enzymes previously considered “undruggable.” Laboratory validation demonstrated effects on cancer cell-cycle regulation and neuronal cell viability. The company is developing selective small molecules and bifunctional degraders targeting modified E2 enzymes for use in neurodegenerative diseases such as Huntington’s disease and challenging oncology indications.

The platform also produces biomarker panels alongside target candidates. In prostate health, NAi identified a Filamin A–associated fragment distinguishing aggressive prostate cancer from benign prostatic hyperplasia, forming the basis of the pstateDx diagnostic panel—a tool designed to reduce false positives and unnecessary biopsies.

Infrastructure and Resources

BPGbio maintains a portfolio of over 400 issued and pending patents worldwide. Its biobank, comprising more than 100,000 clinically annotated human samples, supports validation of NAi-derived discoveries in target identification, biomarker confirmation, and indication expansion studies.

Leadership and Governance

The company’s executive and advisory structure includes experts in biology, AI, and clinical development:

• Executive Leadership: President & CEO, Chief AI and Operations Officer, Interim Chief Medical Officer, and heads of Corporate Strategy, Discovery, Translational Biology, Platform Development, and IT.
• Board of Directors: Includes corporate, financial, and scientific representatives.
• Advisory Board: Composed of leading academic, clinical, and industry experts from major research institutions and health systems.

Collaborations and Research Ecosystem

BPGbio partners with universities, research centers, and hospitals worldwide. Notable collaborations include:

• University of Oxford – Advancing causal inference frameworks for disease modeling
• Oak Ridge National Laboratory – Enhancing high-performance computing capabilities for large-scale biological data analysis.