Company
Our Foundation
Our operations are based in Texas and California, with team members collaborating across multiple locations throughout the United States. We maintain a coordinated operational presence to support our research and manufacturing activities.
Our Values
Guided by our core values of Safety, Innovation, and Quality, Direct Biologics is developing investigational secretome-based products being studied in clinical research under cGMP manufacturing standards. We combine scientific approaches with a focus on quality to support the advancement of clinical research programs.
Our Vision
To advance research in cGMP-manufactured, secretome-based investigational products—including extracellular vesicles (EVs)—derived from adult bone marrow mesenchymal stem cells, advancing the future of regenerative medicine.
Our Mission
Our mission is to advance investigational therapies being studied to better understand their potential effects on immune and inflammatory pathways.
These approaches are investigational and have not been approved by the U.S. Food and Drug Administration. Their safety and efficacy have not been established.
Advancing Science Through Research
Our Journey
- 2017Direct Biologics was founded by Mark Adams and Joe Schmidt
- 2019Commercialized a cGMP product under FDA’s HCT/P 361 tissue regulations
- 2020Initiated multiple clinical programs in response to COVID-19, a Phase II ARDS trial, an expanded access program as well as participation in Operation Warp Speed
- 2021Completed Phase II trial for Mod-Severe ARDS associated with COVID-19
- 2022Opened full-time corporate office in Austin
- Launched Phase I clinical trials for ulcerative colitis and Crohn’s disease
- FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation for COVID-19 associated ARDS
- Initiated Phase III clinical trial for COVID-19 associated ARDS
- 2023Received FDA agreement to expand the Phase III trial to Classic ARDS
- Initiated a Phase IB/IIA study for patients with perianal fistulizing Crohn’s disease
- 2024Moved into a new combined Quality Control and R&D laboratory facility in San Diego, CA
- 2025Expanded manufacturing and quality systems
- 20269 patents issued globally, 81 pending, with 1 additional patent allowed in Australia*
* Patents Awarded include: 12213995, 285419, 12453743, 2021261384, 2020225364, 12502407, 12569517, 12570980, 12590310
The Executive Team
Our executive team brings decades of experience across operations, science, and commercialization. Their hands-on leadership ensures strategic alignment, operational excellence, and disciplined growth across the organization.
Mark Adams
Co-Founder, Chairman & CEO
Mark Adams is the Co-Founder, Chairman, and CEO of Direct Biologics and is a serial entrepreneur who has launched over 25 companies across multiple industries. Mark is a past recipient of the Ernst & Young Entrepreneur of the Year Award. Mark was also formally recognized as an “Outstanding Texas Entrepreneur” by the Governor of the State of Texas and Texas Legislature. With a background in global leadership roles and a track record of scaling companies, he is now focused on advancing Direct Biologics’ drug platform.
John Vacalis, JD
President & Chief Legal Officer
John Vacalis is the President and Chief Legal Officer of Direct Biologics, bringing a strong legal background from private practice and prior roles as outside general counsel to the company since 2018. He oversees a broad range of legal and regulatory matters while supporting the company's strategic objectives, drawing on experience advising clients from startups to global investors.
Tim Moseley, PhD
Chief Scientific Officer
Dr. Tim Moseley is a stem cell biologist with extensive academic and industry experience, specializing in regenerative medicine, tissue repair, and cellular therapies. He has led scientific innovation and product development across multiple biotech organizations and now oversees scientific efforts to support the clinical development of investigational therapies.
Jeff Mims
Chief Financial Officer
Jeff Mims is an experienced C-suite executive with over 25 years in finance and operations, known for driving strategic focus and improving organizational performance across diverse industries. He has a strong track record of optimizing processes, scaling businesses efficiently, and leading companies to profitability while maximizing shareholder value.
Paul Tebbey, PhD
Chief Operating Officer
Dr. Paul Tebbey is a seasoned pharmaceutical development leader with over 30 years of experience across major biotech and pharma companies, specializing in advancing biologics, vaccines, and cell-based therapies from development through commercialization. He has led global teams across regulatory, clinical, and manufacturing functions and played key roles in the success of major therapies, combining deep scientific expertise with strategic business leadership.
All candidate therapies listed on this website are investigational and have not been approved by the U.S. Food and Drug Administration.