HDT Bio

What HDT Bio does

HDT Bio Corp. is a clinical-stage private biopharmaceutical company founded in 2018 and headquartered in Seattle, Washington, with a secondary office in Redmond, WA and a wholly owned subsidiary in Canada. The company develops RNA-based vaccines and immunotherapies for infectious disease and oncology, built around two proprietary technology pillars: the LION™ (Lipid InOrganic Nanoparticle) delivery system, which uses electrostatic interactions to stabilize and deliver RNA without encapsulation, and self-amplifying replicon RNA (repRNA), which enables immune activation at doses up to 20x lower than conventional mRNA vaccines. The combined AMPLIFY™ platform supports multivalent formulations and refrigerator-temperature stability (2–8°C), eliminating the ultra-cold-chain requirements that constrain conventional mRNA distribution.

The company's pipeline spans infectious disease vaccines (HDT-301 COVID-19/GEMCOVAC, HDT-321 CCHF, HDT-331 Nipah virus, EV-D68, malaria via license, tuberculosis, HIV), a broad-spectrum intranasal antiviral (HDT-201), and four oncology candidates (HDT-501 breast, HDT-401 glioblastoma, HDT-521 prostate, HDT-511 pancreatic), supported by ACCESS junction-opener technology for enhanced tumor penetration. HDT Bio generates revenue primarily through non-dilutive U.S. government contracts (DoD, HHS/BARDA, NIH/NIAID, U.S. Army), supplemented by technology licensing to partners such as MalarVx and clinical-stage collaborations with UTMB, Fred Hutch Cancer Center, NCI, SENAI CIMATEC (Brazil), Quratis (South Korea), and University of Pretoria/PACRI (Africa). Its customer base is concentrated in U.S. federal biodefense and pandemic preparedness programs, with international reach via clinical trial and licensing partners. GEMCOVAC's June 2022 Emergency Use Approval in India marked the first regulatory authorization of a self-amplifying RNA vaccine globally.

Name

HDT Bio

Legal name

HDT Bio Corp.

Website

https://hdt.bio

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

51–100 employees

Short description

HDT Bio is a clinical-stage Seattle biotechnology company developing RNA vaccines and immunotherapies for infectious disease and oncology using its proprietary LION™ nanoparticle delivery system and self-amplifying repRNA platform, serving U.S. federal biodefense agencies and global health partners.

Ownership category

akta.pro rank

Product category

RNA Vaccines and Therapeutics

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

Vaccine Technology Platforms (mRNA, viral vector, protein subunit, inactivated/live-attenuated, VLP, DNA) (HLAAAEAD)

akta.pro secondary industries

RNA Delivery Technologies (LNPs, polymers, conjugates incl. GalNAc, peptides, exosomes) (HLAAADAD), mRNA Therapeutics (vaccines, protein replacement, immuno-oncology) (HLAAADAA), Infectious Disease & Pandemic Preparedness Vaccines (emerging pathogens) (HLAAAEAC), Therapeutic Vaccines (e.g., Cancer/Chronic Infection) (HLAIAEAG), Pandemic Preparedness & Rapid-Response Vaccines (HLAIAEAF)

Keywords

• RNA vaccine development
• Lipid nanoparticle delivery
• Infectious disease vaccines
• Cancer immunotherapy
• Biodefense vaccines

Headquarters

HQ city

Seattle

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Government Contracts and Grants: HDT Bio generates significant revenue through government contracts with DoD, HHS/BARDA, NIH/NIAID for biodefense and pandemic preparedness vaccine development. Includes prototype project funding, SBIR grants, and cooperative agreements.
2. Licensing Royalties: The company licenses its repRNA/LION technology to international partners such as MalarVx for malaria vaccines, receiving licensing fees and potential milestone payments. Territory-limited and field-limited license agreements generate revenue while expanding global reach.
3. Vaccine Product Sales: Revenue from sales of vaccine products such as GEMCOVAC, the company's COVID-19 vaccine that received Emergency Use Approval in India. The first self-amplifying RNA vaccine to receive regulatory authorization.
4. Strategic Partnerships and Collaborations: Revenue through collaborative development agreements with partners including NCI, Fred Hutch, and international institutions. Partnerships provide funding commitment, validate technology, and enable clinical development across multiple geographies.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels5 records

Core offering

HDT Bio develops RNA-based vaccines and immunotherapies for infectious diseases and oncology, built on its proprietary LION™ lipid nanoparticle delivery system and self-amplifying replicon RNA (repRNA) technology (the AMPLIFY™ platform). Its clinical pipeline includes GEMCOVAC (the first self-amplifying RNA vaccine ever approved, in India for COVID-19), HDT-321 (CCHF, FDA IND-cleared), HDT-331 (Nipah virus), HDT-201 (broad-spectrum intranasal antiviral), and multiple cancer vaccine candidates for breast, brain, prostate, and pancreatic cancers. The company also licenses its LION™/repRNA technology to partners such as MalarVx for malaria vaccine development.

Product overview

HDT Bio is a clinical-stage biotechnology company developing advanced RNA vaccine and immunotherapy products using its proprietary LION™ (Lipid InOrganic Nanoparticle) delivery system and AMPLIFY™ platform (combining self-amplifying replicon RNA with LION™). The product portfolio spans infectious disease vaccines including HDT-301 (COVID-19, Phase 3), HDT-321 (CCHF, Phase 1), HDT-331 (Nipah virus), and HDT-201 (broad-spectrum antiviral nasal spray), alongside an oncology pipeline targeting breast (HDT-501), brain (HDT-401), prostate (HDT-521), and pancreatic (HDT-511) cancers. The company also offers ACCESS junction opener technology for improved tumor penetrance. HDT Bio's vaccines feature superior safety, potency, and temperature stability compared to conventional mRNA vaccines, with regulatory authorization achieved in India for their COVID-19 vaccine.

Differentiator

Problem solved

Functional benefit

Brands

• LION™: Proprietary lipid nanoparticle delivery system for RNA vaccines and immunotherapies
• AMPLIFY™
• ACCESS

Products and services

• LION™ (Lipid InOrganic Nanoparticle) Delivery System Proprietary lipid nanoparticle delivery platform that stabilizes and delivers RNA to the immune system via electrostatic interactions. Provides superior safety, increased potency, simplified manufacturing, and improved temperature stability compared to traditional RNA delivery systems, and serves as the foundational technology underlying all HDT Bio vaccine candidates.
• AMPLIFY™ Vaccine Platform Combined platform integrating self-amplifying replicon RNA (repRNA) with LION™ formulation technology. Offers increased safety and potency, simplified manufacturing, improved temperature stability, and enables multivalency — delivering multiple RNA molecules targeting different antigens or variants in a single vaccine.
• HDT-301 (Gemcovac) COVID-19 vaccine using self-amplifying RNA technology with LION™ delivery system. Demonstrated exceptional safety profile, administered to over 6,000 patients. Received Emergency Use Authorization in India; Phase 1 trials conducted in U.S., Brazil, and South Korea.
• HDT-321 (CCHF Vaccine) First-in-class prophylactic vaccine targeting Crimean-Congo Hemorrhagic Fever (CCHF), a deadly tick-borne viral disease. Built on LION™ platform combined with CCHF-specific discoveries. Received FDA IND clearance in September 2025 and entered Phase 1 clinical trial.
• HDT-331 (Nipah Virus Vaccine) Vaccine candidate for Nipah virus (NiV), a zoonotic virus causing encephalitis and severe respiratory disease. Developed using the LION™ platform as part of an $87.4M U.S. government award for development through Phase 1 trials.
• HDT-201 (RIG-I Agonist RNA Antiviral) Broad-spectrum antiviral intranasal spray utilizing a RIG-I activating RNA molecule delivered via LION™ system. Stimulates innate immune response against deadly respiratory viruses including SARS-CoV-2, influenza, and RSV. Room-temperature stable for 6 months and refrigerator-stable for 18+ months.
• HDT-501 (Breast Cancer Vaccine) Cancer vaccine candidate targeting breast cancer. Uses the LION™ platform to enable localized, T cell-mediated immunological memory responses against tumor-associated antigens for cancer treatment.
• HDT-401 (Glioblastoma Vaccine) Cancer vaccine candidate targeting glioblastoma (brain cancer). Leverages LION™ platform for localized immune responses against tumor cells, supported by Dr. Charles Cobbs' CMV-glioma biology expertise.
• HDT-521 (Prostate Cancer Vaccine) Cancer vaccine candidate targeting prostate cancer. Developed as part of an NCI collaboration for cancer prevention using self-amplifying RNA vaccine technology with LION™ delivery.
• HDT-511 (Pancreatic Cancer Vaccine) Cancer vaccine candidate targeting pancreatic cancer. Targets tumor-associated antigen expression to stimulate immune response, supported by Dr. Elizabeth Jaffee's pancreatic cancer immunotherapy expertise.
• ACCESS Junction Opener Technology Viral protein-derived technology that disrupts cellular junctions in epithelial tissue to increase tumor microenvironment accessibility. Improves efficacy of therapeutics including chemotherapeutics, antibodies, oncolytic viruses, and cell therapies for epithelial tumors.
• EV-D68 Vaccine Self-amplifying RNA vaccine against enterovirus D68, a respiratory virus causing acute flaccid myelitis (AFM) in children. LION™-formulated repRNA demonstrated neutralizing antibody responses in mice and nonhuman primates.

Quantifiable outcome

• Up to 20x lower dose required compared to conventional mRNA vaccines
• +3 more outcomes

Named customers6 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

14 partnerships are on record, tiered major, core and minor.

• MalarVx, Inc.majorOEM/ Whitelabel/ Licensing Partner · 15 January 2025License to HDT Bio's proprietary repRNA/LION technology for malaria vaccine development. MalarVx is a Seattle-based clinical-stage vaccine company focused on Plasmodium falciparum prevention.
• Albert Einstein College of Medicine (PROVIDENT Consortium)coreStrategic or Co-development Partner · 17 September 2024HDT Bio's Rapid-Response Roadmap for RNA vaccines (R4) project as part of PROVIDENT - a national consortium led by Albert Einstein College of Medicine and funded by NIAID for pandemic preparedness. Five-year subaward for $2M per year.
• Pan African Cancer Research Institute (PACRI) - University of PretoriamajorStrategic or Co-development Partner · 30 January 2023Collaboration to apply HDT Bio's RNA technology and LION delivery systems for development of cancer vaccines and treatments for Africa. Includes commitment to clinical trials conducted in Africa.
• University of Texas Medical Branch (UTMB)coreStrategic or Co-development Partner · 30 November 2022Collaborative development of CCHF and Nipah virus vaccines using LION platform. UTMB leads the $87.4M project with HDT Bio as sub-performer allocated $49M. Collaboration includes NIAID's Rocky Mountain Laboratories for preclinical testing.
• Quratis (South Korea)majorStrategic or Co-development Partner · 13 December 2021Partnership for Phase 1 trial of RNA COVID-19 vaccine in South Korea with goal of making vaccine available across East Asia.
• SENAI CIMATEC (Brazil)majorStrategic or Co-development Partner · 31 August 2021Partnership to advance RNA COVID-19 vaccine for pandemic response in Brazil. Clinical trials conducted in Salvador, Brazil.
• Medical CBRN Defense Consortium (MCDC)coreStrategic or Co-development PartnerFostering collaboration between industry, academic, and non-profit partners for advanced development to support DoD's medical pharmaceutical and diagnostic requirements.
• National Cancer Institute (NCI) - PREVENT ProgramcoreStrategic or Co-development PartnerPreclinical development of cancer vaccines using LION platform technology with potential expansion to clinical trials.
• National Institute of Allergy and Infectious Diseases (NIAID)coreStrategic or Co-development PartnerCollaborative research on CCHF vaccine development with pre-clinical testing at Rocky Mountain Laboratories.
• Johnson & Johnson Innovation - JLABS / Blue KnightmajorStrategic or Co-development PartnerSelected to participate in prestigious collaboration between JLABS and BARDA for anticipating public health risks and amplifying scientific advancements.
• Fred Hutch Cancer CentermajorStrategic or Co-development PartnerCollaboration for cancer research leveraging immune system potential to mitigate disease.
• Rocky Mountain Laboratories (NIAID/NIH)coreStrategic or Co-development PartnerCollaboration on EV-D68 vaccine research and CCHF vaccine development at high-containment facility in Montana.
• Duke UniversityminorStrategic or Co-development PartnerCollaboration on maternal and neonatal immunization research using repRNA/LION platform.
• Seattle Children's Research InstituteminorStrategic or Co-development PartnerCollaboration on maternal and neonatal immunization research using repRNA/LION platform.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Arcturus Therapeutics: Arcturus is the closest direct peer: a clinical-stage developer of self-amplifying mRNA (saRNA) vaccines and therapeutics, with a comparable platform approach (LUNAR delivery + replicon RNA) targeting infectious disease and rare diseases. Both companies competed in the same first wave of saRNA vaccine developers pursuing regulatory authorization.
• Gritstone bio: Gritstone develops self-amplifying RNA cancer vaccines and infectious disease vaccines using a similar saRNA + nanoparticle delivery approach, targeting oncology and pandemic preparedness markets that overlap directly with HDT Bio's pipeline.
• Replicate Bioscience: Replicate is an early-stage saRNA vaccine developer focused on oncology and infectious disease, working on similar self-amplifying RNA platform technology with comparable target indications and clinical-stage positioning.

Broad incumbents

• CureVac: CureVac is a clinical-stage mRNA company developing prophylactic vaccines, cancer vaccines, and molecular therapies using both conventional and self-amplifying RNA. As a larger and more broadly diversified mRNA player, it overlaps with HDT's core technology category but operates across multiple RNA modalities.
• Moderna: Moderna is the dominant commercial mRNA vaccine company and a broad incumbent in the same technology category. While its current commercial portfolio uses conventional mRNA, Moderna is actively developing saRNA and next-generation formulations that overlap with HDT Bio's R&D roadmap.
• BioNTech: BioNTech is a global mRNA leader with extensive infectious disease and oncology vaccine pipelines, and is investing in saRNA and improved delivery formulations that compete directly with HDT Bio's LION platform in target indications and customers.
• Novavax: Novavax is a commercial-stage vaccine developer with a focus on recombinant protein nanoparticle vaccines targeting infectious disease, including pandemic preparedness. While not an mRNA company, it competes with HDT Bio for the same biodefense and global health vaccine opportunities.

Emerging players

• Ziphius Vaccines: Ziphius is a Belgian early-stage biotech developing self-amplifying RNA vaccines for infectious disease, with a platform approach and target indications that closely mirror HDT Bio's infectious disease and rare disease focus.
• Orlance: Orlance is a nucleic acid vaccine and immunotherapy developer co-founded by HDT Bio scientific advisor Deborah Fuller, focused on needle-free delivery of DNA and RNA vaccines. Comparable as an early-stage nucleic acid vaccine platform company with overlapping technology roots.

Others

• Afrigen Biologics: Afrigen Biologics is a Cape Town-based mRNA vaccine manufacturer co-founded by HDT Bio CEO Steve Reed. While it operates more as a CDMO/manufacturing hub for LMIC mRNA vaccines, it shares leadership DNA and global health positioning with HDT Bio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/hdtbio
• LinkedInlinkedin.com/company/hdt-bio

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Subsidiaries1 record

Funding overview

Funding rounds8 records

Investors7 records

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M&A

Investments

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Frequently asked questions about HDT Bio