Direct Biologics
Direct Biologics is a privately held clinical-stage biotech developing MSC-derived secretome-based biologic candidates led by ExoFlo for ARDS and inflammatory bowel disease indications, advancing through Phase III trials under FDA RMAT designation.
- Company typePrivate
- Founded2017
- HeadquartersAustin, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Direct Biologics does
Direct Biologics is a privately held clinical-stage biopharmaceutical company founded in 2017 in Austin, Texas, developing investigational secretome-based biologic product candidates derived from adult bone marrow mesenchymal stem cells (MSCs). The company's core platform, branded "Natural Intelligence™," leverages MSC-derived extracellular vesicle (EV)-enriched secretome manufactured under current Good Manufacturing Practice (cGMP) standards, combined with AI-enabled multi-omics analyses for proteomic and transcriptomic characterization. Its lead product candidate, ExoFlo (also designated DB-2Q), is being evaluated in a Phase III clinical trial for Acute Respiratory Distress Syndrome (ARDS), including both COVID-19-associated and Classic ARDS indications, and received FDA Regenerative Medicine Advanced Therapy (RMAT) designation in 2022.
The company's pipeline extends into inflammatory bowel disease, with DB-3Q in Phase IB/IIA development for perianal fistulizing Crohn's disease and additional Phase I/II programs for medically refractory Crohn's disease and ulcerative colitis (DB-3Y). Direct Biologics also commercialized a cGMP product in 2019 under FDA's HCT/P 361 tissue regulations. The company holds 9 issued patents globally with 81 pending applications, and operates from Austin, Texas with a Quality Control and R&D laboratory facility in San Diego, California opened in 2024.
Direct Biologics has no FDA-approved products and generates no disclosed commercial product revenue; the company's economics are funded by approximately $116M in cumulative disclosed private funding across five rounds from 2018 through 2022. Its customer base is exclusively clinical trial sites and patient populations enrolled in investigational studies, and pricing is not publicly disclosed because all candidates remain investigational.
Direct Biologics firmographics
Firmographics- Name
- Direct Biologics
- Legal name
- Direct Biologics
- Website
- https://directbiologics.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Direct Biologics is a privately held clinical-stage biotech developing MSC-derived secretome-based biologic candidates led by ExoFlo for ARDS and inflammatory bowel disease indications, advancing through Phase III trials under FDA RMAT designation.
- Ownership category
- akta.pro rank
Direct Biologics industry classification
Industry- Product category
- Regenerative Biologics
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)
- akta.pro secondary industry
- Gastroenterology Specialty Pharmaceuticals (HLAIACAE)
Keywords
Where Direct Biologics is headquartered
LocationHeadquarters
- HQ city
- Austin
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Direct Biologics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Infrastructure, Marketing or Sales
Direct Biologics product offering
Product offeringCore offering
Direct Biologics develops investigational, secretome-based biologic product candidates derived from adult bone marrow mesenchymal stem cells, manufactured under cGMP standards for use in clinical research. Its lead candidate ExoFlo is being studied in clinical trials for Acute Respiratory Distress Syndrome (ARDS), Perianal Fistulizing Crohn's Disease, Medically Refractory Crohn's Disease, and Medically Refractory Ulcerative Colitis. The company's pipeline assets are designated DB-2Q, DB-3Q, and DB-3Y across multiple clinical phases. All products are investigational and have not been approved by the FDA.
Product overview
Direct Biologics is a biopharmaceutical company developing investigational secretome-based biologics. The company's core platform is Natural Intelligence™, which leverages mesenchymal stem cell (MSC)-derived secretome and extracellular vesicle (EV)-enriched products manufactured under cGMP standards. The primary product candidate is ExoFlo, which is in clinical development for Acute Respiratory Distress Syndrome (ARDS), Perianal Fistulizing Crohn's Disease, Medically Refractory Crohn's Disease, and Medically Refractory Ulcerative Colitis. The company's pipeline includes multiple investigational products designated DB-2Q, DB-3Q, and DB-3Y across various phases of clinical trials. These products are investigational and have not been approved by the FDA.
Differentiator
Problem solved
Functional benefit
Products and services
- ExoFlo ExoFlo is Direct Biologics' lead investigational exosome-based secretome product candidate derived from adult bone marrow mesenchymal stem cells, currently in clinical development for acute respiratory distress syndrome (ARDS) and additional indications including Perianal Fistulizing Crohn's Disease, Medically Refractory Crohn's Disease, and Medically Refractory Ulcerative Colitis.
- DB-2Q Investigational product candidate in Phase III clinical development for Acute Respiratory Distress Syndrome (ARDS), including COVID-19 associated ARDS and Classic ARDS. Holds FDA Regenerative Medicine Advanced Therapy (RMAT) designation for COVID-19 associated ARDS.
- DB-3Q Investigational product candidate in Phase IB/IIA clinical study for Perianal Fistulizing Crohn's Disease and Phase I/II trials for Medically Refractory Crohn's Disease.
- DB-3Y Investigational product candidate in Phase I/II clinical trials for Medically Refractory Ulcerative Colitis.
Companies that use Direct Biologics
Customer profileSegments3 records
Ideal customer profiles3 records
Direct Biologics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Direct Biologics partnerships and signals
Strategic signalScale indicators5 records
Recent moves8 records
Expansion highlights4 records
Direct Biologics competitors and assessment
Company assessmentDirect peers
- Capricor Therapeutics: Clinical-stage biotech developing exosome-based therapeutics (CAP-1002 and derivative exosome programs) for inflammatory and rare disease indications. Direct comparable as both companies leverage extracellular vesicle technology derived from cellular sources for clinical applications.
- Mesoblast: Commercial-stage cell therapy company developing mesenchymal stem cell (MSC)-based therapies for inflammatory conditions including ARDS and graft-versus-host disease. Highly comparable given shared MSC platform foundation and overlapping ARDS indication.
- Pluristem Therapeutics: Clinical-stage regenerative medicine company developing placenta-derived MSC therapies for inflammatory and ischemic conditions. Comparable as a stem cell-derived biologic platform targeting similar inflammatory indications.
- Evox Therapeutics: Clinical-stage biotech engineering extracellular vesicles/exosomes as targeted therapeutics for rare diseases and inflammatory conditions. Closely comparable exosome engineering platform and therapeutic development model.
- Celularity Inc. Clinical-stage cellular therapeutics company developing placental-derived MSC and other cell-based therapies for cancer, autoimmune, and degenerative diseases. Comparable regenerative medicine platform and stem cell-derived therapeutic approach.
- Athersys: Clinical-stage regenerative medicine company developing MultiStem cell therapy for ARDS, stroke, and inflammatory conditions. Directly comparable given shared ARDS indication and stem cell-based therapeutic approach.
Emerging players
- Arcturus Therapeutics: Clinical-stage biotech developing RNA-based therapeutics and cell therapy approaches for inflammatory and rare diseases. Comparable as an emerging player in advanced biologics with overlapping inflammatory disease focus.
Broad incumbents
- Bristol Myers Squibb: Large pharmaceutical company with established IBD franchise (Zeposia for UC, multiple Crohn's programs) and respiratory therapeutic portfolios. Relevant incumbent competing for the same end markets with broader commercial capabilities.
- AbbVie: Global biopharmaceutical company dominating IBD treatment with Humira, Skyrizi, and Rinvoq franchises. Critical incumbent whose commercial scale and formulary access represent the primary competitive barrier for Direct Biologics' IBD pipeline.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat3 records
Key risks6 records
Key highlights7 records
Customer concentration
Direct Biologics social profiles
Digital presenceDirect Biologics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Direct Biologics leadership team
Management profileNumber of profiles
Profiles6 records
Direct Biologics funding detail
Funding detailFunding overview
Funding rounds5 records
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Direct Biologics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Direct Biologics
What does Direct Biologics do?
Direct Biologics develops investigational, secretome-based biologic product candidates derived from adult bone marrow mesenchymal stem cells, manufactured under cGMP standards for use in clinical research. Its lead candidate ExoFlo is being studied in clinical trials for Acute Respiratory Distress Syndrome (ARDS), Perianal Fistulizing Crohn's Disease, Medically Refractory Crohn's Disease, and Medically Refractory Ulcerative Colitis. The company's pipeline assets are designated DB-2Q, DB-3Q, and DB-3Y across multiple clinical phases. All products are investigational and have not been approved by the FDA.
Is Direct Biologics a public or private company?
Direct Biologics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Direct Biologics founded?
Direct Biologics was founded in 2017. It employs 11 to 50 people.
Where is Direct Biologics based?
Direct Biologics is headquartered in Austin, United States, in the North America region.
Who are Direct Biologics's main competitors?
Direct peers on record are Capricor Therapeutics, Mesoblast, Pluristem Therapeutics, Evox Therapeutics, Celularity Inc. and Athersys. Arcturus Therapeutics is listed as an emerging player. Broad incumbents are Bristol Myers Squibb and AbbVie.
Does Direct Biologics have an API?
No public API is recorded for Direct Biologics.
What industry is Direct Biologics in?
Direct Biologics's product category is Regenerative Biologics. Its primary akta.pro industry code is HLAIACAB, Immunology & Autoimmune Specialty Pharmaceuticals, with a secondary code of HLAIACAE, Gastroenterology Specialty Pharmaceuticals. Its NAICS code is 325414 and its SIC code is 2836.