ProPhase Labs, Inc.

ProPhase Labs, Inc.

Corporate and structure highlights

• Principal executive offices: 626 RXR Plaza, 6th Floor, Uniondale, NY 11556
• Delaware incorporation; website: www.ProPhaseLabs.com
• 19 full-time employees as of December 31, 2025
• Historically operated two CLIA-certified diagnostic laboratories under ProPhase Diagnostics (Old Bridge, NJ, and Garden City, NY)
• Key corporate events:
  • ProPhase Diagnostics and related entities filed Chapter 11 on September 22, 2025; the Company deconsolidated the Debtors
  • PMI (Pharmaloz Contract Manufacturing) was sold, effective January 16, 2025

Core business lines and activities

1. Nebula Genomics and DNA Complete (genomics testing and consumer genomics)

• Nebula Genomics, Inc. (wholly owned): whole genome sequencing (WGS) and related genomic services for consumers
• DNA Complete (wholly owned): direct-to-consumer WGS offerings with three tiers:
  • Essential: 1x WGS — >175 reports
  • Pro: 30x WGS — >250 reports
  • Elite: 100x WGS — >350 reports
• Platform and data features:
  • Subscription-enabled platform with hundreds of personalized reports and ongoing insights
  • Over 300 personalized reports; Nebula Expand allows users to upload data from other tests to uncover additional variant information (~50x more data points from >35 million variants)
  • Gene browser and gene analysis tools; secure online customer portal and weekly educational content
• Sequencing scale: the test decodes approximately 6.4 billion base pairs of the human genome
• Distribution: online direct-to-consumer sales with plans for retail and university testing; subscription model for ongoing insights
• Cost position: Nebula has cited being the first company to bring sequencing cost below $300 per human genome

2. PBIO (ProPhase BioPharma) and drug/dietary supplement initiatives

• ProPhase BioPharma, Inc. (PBIO): licensing, development, and commercialization of novel drugs, dietary supplements, and related compounds
• Linebacker LB-1 and LB-2 (licensed programs):
  • Exclusive rights for indications including cancer, inflammatory, and memory-related diseases; licensed from Global BioLife
  • Financial terms: $50,000 upfront license fee; $900,000 due after an anticipated Phase 3 milestone; $1,000,000 upon NDA approval; 3% royalties on net revenue; minimum annual royalty of $250,000
  • Term: country-by-country expiration aligned with patent lifecycles; post-term rights become non-exclusive, perpetual, and royalty-free in each country
  • Clinical collaboration and development work with partners including Dana-Farber/Harvard Medical School and use of CertisAI Predictive Oncology Intelligence to guide development
• TK Supplements® consumer brand:
  • Product lines include Legendz XL® (male sexual health) and Triple Edge XL® (energy/stamina)
  • Equivir daily supplement (immune support) is planned; India trial results referenced and SAR/final reports in preparation

3. BE-Smart Esophageal Pre-Cancer Diagnostics (exclusive IP)

• Exclusive rights to BE-Smart Esophageal Pre-Cancer diagnostics test and associated IP
• Test objective: early detection of progression from Barrett’s esophagus to esophageal adenocarcinoma
• Collaborations and validation: partnership with mProbe and Mayo Clinic researchers; an 8-protein, MS-based assay reported in initial work
• Development path: planned as a Laboratory Developed Test (LDT) with ongoing optimization in collaboration with Mayo Clinic and mProbe
• Market parameters included in the source information:
  • Target population: high-risk endoscopy patients (Barrett’s Esophagus and related cohorts)
  • Estimated reimbursement range: $1,000 to $2,000 per test
  • Estimated addressable market: $7 billion to $14 billion per year
  • Intended use: inform treatment decisions and potentially reduce unnecessary endoscopic procedures

4. ProPhase Diagnostics (historical) and PMI (discontinued operations)

• ProPhase Diagnostics operated CLIA laboratories offering COVID-19 PCR and rapid antigen testing
• Regulatory and reimbursement context described in source material (CARES Act, HRSA uninsured program, PAMA, etc.)
• 2024–2025 status: demand and reimbursement declines led to paused services; Debtors filed Chapter 11 in September 2025 and were deconsolidated
• PMI (Pharmaloz Contract Manufacturing):
  • Full-service contract manufacturing for cough drops/lozenges and OTC products; facility registered with FDA and holds organic/kosher certifications
  • Sold to JL Projects, Inc., effective January 16, 2025
  • For 2024 and 2023, PMI activities were classified as discontinued operations with related gains/losses and tax effects

Licensing and intellectual property portfolio

• Equivir and Equivir G: exclusive rights licensed from Global BioLife with a global license framework and future sublicensing ability
• Linebacker LB-1 and LB-2: exclusive licenses with development milestones and royalty obligations; collaboration framework with GRDG/CORI
• BE-Smart IP: BE-Smart Esophageal Pre-Cancer Diagnostics IP and related test tools

Regulatory and market environment

• Diagnostics and OTC/pharmaceutical products subject to FDA regulation; CLIA and state laboratory licensing requirements apply to laboratory operations
• Dietary supplements regulated under DSHEA; cGMPs and FSMA considerations for manufacturing and safety
• Privacy and genetic data considerations include HIPAA, HITECH and potential GDPR implications for international data handling
• Reimbursement landscape considerations cited: PAMA/CMS rules, private payor dynamics, and Medicare/Medicaid frameworks

Notable operating and financial details included in the source

• Employees: 19 full-time as of December 31, 2025
• Corporate events summarized:
  • ProPhase Diagnostics and related Debtors filed Chapter 11 on September 22, 2025 and were deconsolidated
  • PMI sold for $2 million in cash; extinguishment of approximately $11 million of debt; transfer of roughly $3 million in payables, $1 million in capital leases, and more than $3 million in planned capital expenditures
• BE-Smart market data and pricing estimates were provided in the source material
• Nebula and DNA Complete operate a direct-to-consumer subscription model with ongoing data updates and consumer education content

If you want this condensed further into a one-page executive summary or expanded into separate investor- or product-focused briefings, I can prepare that next.