Humanetics Corporation
Humanetics Corporation is a clinical-stage pharmaceutical company developing BIO 300, an orally administered radiation modulator drug, for U.S. military biodefense against Acute Radiation Syndrome, oncology radioprotection, and inflammatory lung diseases including IPF and COVID-19 pulmonary complications.
- Company typePrivate
- Founded2012
- HeadquartersMinneapolis, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Humanetics Corporation does
Humanetics Corporation is a clinical-stage specialty pharmaceutical company headquartered in Edina, Minnesota, developing a single drug candidate — BIO 300 (brand name BYOGRAYZ™) — an orally administered isoflavone nanoparticle formulation that acts as a radiation modulator by repressing NF-κB expression and activation. The company pursues three parallel therapeutic applications: (1) biodefense as a prophylactic Medical Countermeasure against Acute Radiation Syndrome for U.S. military warfighters and first responders; (2) oncology radioprotection to reduce treatment-related toxicities in patients receiving radiotherapy for NSCLC, head and neck cancers, and prostate cancer; and (3) inflammatory lung diseases including COVID-19 long-haul pulmonary complications and idiopathic pulmonary fibrosis. BIO 300 is protected by a portfolio of issued U.S. patents (including composition-of-matter, oral nanosuspension formulation, and indication-specific method-of-use claims) and has received FDA Fast Track Designation and Orphan Drug Designation for the Prevention of Acute Radiation Syndrome.
The business model is pre-revenue and entirely grant- and contract-funded. Humanetics has secured approximately $45–50 million in non-dilutive capital since 2012 across more than a dozen awards from the U.S. Department of Defense (including a 5-year $20M OTA plus $5M supplement and a separate $3M USU cooperative agreement), NIAID, NCI, NHLBI, BARDA, and NASA. The go-to-market motion is enterprise/government field sales, targeting DoD and federal agencies via Other Transaction Authority (OTA) agreements and SBIR grants for biodefense indications, and academic medical centers (Memorial Sloan Kettering, NYU Langone, Henry Ford Health, University of Maryland) for investigator-initiated oncology and pulmonary trials. Commercial distribution upon FDA approval is expected to flow through Strategic National Stockpile channels for biodefense and specialty pharmacy/GPO channels for oncology and pulmonary indications.
Strategic positioning is reinforced by leadership with deep U.S. military medical expertise — including a CMO who is a retired Navy Rear Admiral and former 14th Joint Staff Surgeon, and board members including the former Surgeon General of the Navy and a retired Army Major General who commanded USAMRMC. Manufacturing is being secured via a 2020 acquisition of DSM Nutritional Products' BIO 300 API assets (patents, trade secrets, regulatory filings) and a March 2025 CDMO partnership with Lifecore Biomedical for fill-finish and pilot production, positioning the company for U.S.-based domestic supply required for stockpile procurement. Revenue is not anticipated until FDA approval and commercial launch, with the lead ARS/EUA pathway being the most likely first commercial event.
Humanetics Corporation firmographics
Firmographics- Name
- Humanetics Corporation
- Legal name
- Humanetics Corporation
- Website
- https://humaneticscorp.com
- Company type
- Private
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Humanetics Corporation is a clinical-stage pharmaceutical company developing BIO 300, an orally administered radiation modulator drug, for U.S. military biodefense against Acute Radiation Syndrome, oncology radioprotection, and inflammatory lung diseases including IPF and COVID-19 pulmonary complications.
- Ownership category
- akta.pro rank
Humanetics Corporation industry classification
Industry- Product category
- Radiation Countermeasure Pharmaceuticals
- NAICS
- Medicinal and Botanical Manufacturing (325411), Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Pharmaceutical Preparations (2834), Medicinal Chemicals & Botanical Products (2833)
- akta.pro primary industry
- Radiation Oncology (HLAKAFAC)
Keywords
Where Humanetics Corporation is headquartered
LocationHeadquarters
- HQ city
- Minneapolis
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Humanetics Corporation business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- Pre-revenue / Clinical Stage: Humanetics is an advanced clinical-stage specialty pharmaceutical company with no commercial revenue. Revenue is anticipated upon FDA approval and commercial launch of BIO 300 across its oncology, medical countermeasure, and pulmonary indications.
Go-to-market motion1 record
Distribution channels3 records
Marketing channels6 records
Humanetics Corporation product offering
Product offeringCore offering
Humanetics Corporation is developing BIO 300 (branded as BYOGRAYZ™), an orally administered isoflavone nanoparticle radiation modulator designed to protect normal tissues from radiation damage. The drug candidate is being advanced across three indication areas: medical countermeasures for Acute Radiation Syndrome (ARS) and Delayed Effects of Acute Radiation Exposure (DEARE), oncology supportive care to reduce radiation therapy toxicity and sensitize tumors, and inflammatory lung diseases including COVID-19 and idiopathic pulmonary fibrosis (IPF).
Product overview
Humanetics Corporation is a clinical-stage specialty pharmaceutical company focused on the development of BIO 300 (also marketed as BYOGRAYZ™), a single proprietary drug product. BIO 300 is an orally administered radiation modulator designed to protect normal tissues from radiation damage across three therapeutic applications: (1) as a medical countermeasure for military and first responders against acute radiation syndrome from nuclear incidents, (2) as a radioprotective agent for cancer patients undergoing radiation therapy, and (3) as a treatment for inflammatory lung diseases. The company does not operate a platform or module-based architecture—it is focused exclusively on advancing BIO 300 through clinical development toward FDA approval.
Differentiator
Problem solved
Functional benefit
Brands
- BYOGRAYZ (BIO 300): Brand name for BIO 300, an orally administered prophylactic medical countermeasure designed to protect warfighters from radiation exposure, including data from Phase 1 clinical studies.
- BIOGRAYZ (BIO 300)
Products and services
- BIO 300 (BYOGRAYZ™) Orally administered isoflavone nanoparticle radiation modulator being developed as a prophylactic and supportive-care drug across military/medical countermeasure, oncology, and inflammatory lung disease indications. Intended for government biodefense stockpiling, radiation oncology supportive care, and pulmonary disease treatment.
Quantifiable outcome
- Phase 1b/2a NSCLC trial: 65% tumor response rate, 20% complete response rate; lower rates of hematological, pulmonary, and GI toxicities vs. historical controls; stable quality of life and body weight throughout treatment; serum TGFβ1 reduced in dose-dependent manner
- +2 more outcomes
Companies that use Humanetics Corporation
Customer profileNamed customers4 records
Segments3 records
Ideal customer profiles3 records
Humanetics Corporation technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Humanetics Corporation partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core and minor.
- Memorial Sloan Kettering Cancer CentercoreInvestigator-initiated Phase 2 clinical trial led by Dr. Narek Shaverdian (Director of Thoracic Radiation Oncology) evaluating BIO 300 Oral Suspension in patients with NSCLC and underlying interstitial lung disease. The trial enrolls approximately 24 participants and represents a new oncology application for BIO 300 in a high-risk patient population historically underserved by standard therapies.
- Lifecore BiomedicalcoreHumanetics selected Lifecore Biomedical as the CDMO partner to provide fill-finish, formulation development, analytical method work, and pilot batch production for BIO 300 for the prevention of Acute Radiation Syndrome. This collaboration leverages Minnesota-based Life Science capabilities; Lifecore is a fully integrated CDMO with capabilities in sterile injectable and complex formulations. The agreement supports Humanetics' manufacturing strategy as BIO 300 advances toward regulatory submission.
- Uniformed Services University of the Health Sciences (USUHS) / Armed Forces Radiobiology Research Institute (AFRRI)core$3M cooperative research agreement (August 2024) to develop an auto-injector formulation of BIO 300 for self-administration by military personnel and first responders. Collaborative research continues with DOD scientists at AFRRI. BIO 300's radioprotective effects were originally discovered by researchers at AFRRI, who granted exclusive worldwide rights to Humanetics for development as an MCM.
- Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) / Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical)coreDoD entity managing Humanetics' OTA for Prototype Agreement for advanced development of BIO 300 as a medical countermeasure for ARS. JPM CBRN Medical oversees development activities including utilization of additional $5M funding awarded December 2024. This is the primary government partnership driving BIO 300 toward FDA Emergency Use Authorization.
- NYU Langone HealthcorePrimary clinical site for Phase 2b trial of BIO 300 in COVID-19 patients discharged from hospital with residual lung complications. Led by Dr. Rany Condos (Director, Interstitial Lung Disease Program and Post-COVID Program). Positive results showed statistically significant improvement in pulmonary function maintained at 12 months.
- DSM Nutritional Products LtdcoreHumanetics acquired all DSM assets related to manufacture of the active pharmaceutical ingredient in BIO 300, including patents, trademarks, trade secret manufacturing processes, analytical methods, regulatory filings, and nonclinical/clinical safety studies. Plans to transfer manufacturing to a U.S. site. DSM had developed and patented a method to produce a highly pure form of BIO 300's API.
- U.S. Army Medical Research Institute of Chemical Defense (USAMRICD)minorCooperative Research and Development Agreement (CRADA) to evaluate BIO 300 as a therapeutic for phosgene exposure, a toxic industrial chemical weapon. The collaboration assessed whether BIO 300 can improve survival and mitigate acute and delayed respiratory effects from phosgene inhalation.
- Henry Ford Hospital / Henry Ford Health SystemcoreLong-standing clinical and nonclinical research collaboration for BIO 300 in lung cancer radiotherapy. Dr. Benjamin Movsas (Chair of Radiation Oncology) led Phase 1/2a clinical trial in NSCLC. Henry Ford researchers also conducted nonclinical studies demonstrating BIO 300's ability to protect normal tissues and sensitize tumors to radiotherapy.
Scale indicators13 records
Recent moves6 records
Expansion highlights6 records
Humanetics Corporation competitors and assessment
Company assessmentDirect peers
- Galera Therapeutics: Galera Therapeutics developed avasopasem (GC4419), a superoxide dismutase mimetic designed as a radiation normal tissue protector for head and neck cancer patients — directly comparable to BIO 300's oncology supportive care application for reducing radiation-induced toxicities. Both companies target radioprotection of normal tissues while preserving or enhancing tumor radiosensitivity.
- Soligenix: Soligenix is developing OrbeShield (oral beclomethasone 17,21-dipropionate) as a medical countermeasure for gastrointestinal Acute Radiation Syndrome, directly competing with Humanetics' BIO 300 in the biodefense ARS market. Both companies are also developing indications for cutaneous T-cell lymphoma and other radiation-related conditions.
- Partner Therapeutics: Partner Therapeutics markets LEUKINE (sargramostim/GM-CSF), the only FDA-approved radiation countermeasure indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation — directly comparable to BIO 300's ARS indication. Partner Therapeutics' positioning in the Strategic National Stockpile mirrors Humanetics' intended commercial pathway.
- Cellerant Therapeutics: Cellerant Therapeutics develops CLT-008 (romyelocel-L), a cell-based therapy for use as a medical countermeasure for acute radiation syndrome — directly comparable to BIO 300 in the biodefense/ARS market. Both companies pursue BARDA-funded development and target similar military and civilian stockpiling customers.
Emerging players
- BioMimetix Pharmaceuticals: BioMimetix developed BMX-001, a redox-active manganese porphyrin compound evaluated as a normal tissue radioprotector in cancer patients — directly comparable in mechanism (anti-inflammatory, anti-fibrotic radioprotection) and indication (radiotherapy supportive care). Both are clinical-stage assets targeting reduction of radiation-induced normal tissue toxicity.
- Aeolus Pharmaceuticals: Aeolus Pharmaceuticals developed AEOL 10150 (a catalytic antioxidant compound) as a medical countermeasure for pulmonary radiation injury and ARS — directly comparable in mechanism (anti-inflammatory, anti-fibrotic) and indication to BIO 300's ARS/DEARE pulmonary applications. Represents a relevant historical peer for development pathway.
- Cara Therapeutics: Cara Therapeutics develops difelikefalin and other anti-inflammatory therapeutics targeting NF-κB and cytokine-mediated inflammation — a comparable mechanism of action to BIO 300's NF-κB repression. Both companies target inflammatory pathways in specialty indications with clinical-stage assets.
- Pliant Therapeutics: Pliant Therapeutics develops bexotegrast (PLN-74809) and other integrin-targeting therapeutics for idiopathic pulmonary fibrosis — directly comparable to BIO 300's IPF and pulmonary fibrosis indications. Both companies are clinical-stage developers targeting fibrotic lung disease where no curative treatment exists.
Others
- Humanigen: Humanigen developed lenzilumab, an anti-GM-CSF monoclonal antibody, with work on COVID-19 and inflammation directly analogous to BIO 300's anti-inflammatory mechanism via NF-κB pathway inhibition. COO Timothy Morris previously served as CFO/COO at Humanigen during Operation Warp Speed, creating both strategic overlap and a talent pipeline.
Broad incumbents
- Amgen: Amgen markets Neulasta (pegfilgrastim), which BIO 300 nonclinical studies were explicitly benchmarked against for prevention of delayed radiation-induced lung inflammation and fibrosis. Amgen is the broad incumbent in the radiation supportive care space and a potential strategic acquirer of BIO 300 if Phase 3 data support approval.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Humanetics Corporation social profiles
Digital presenceHumanetics Corporation financial estimates
Financial estimateRevenue estimate
Valuation estimate
Humanetics Corporation leadership team
Management profileNumber of profiles
Profiles6 records
Humanetics Corporation funding detail
Funding detailFunding overview
Funding rounds6 records
Investors4 records
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Humanetics Corporation 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 Humanetics Corporation
What does Humanetics Corporation do?
Humanetics Corporation is developing BIO 300 (branded as BYOGRAYZ™), an orally administered isoflavone nanoparticle radiation modulator designed to protect normal tissues from radiation damage. The drug candidate is being advanced across three indication areas: medical countermeasures for Acute Radiation Syndrome (ARS) and Delayed Effects of Acute Radiation Exposure (DEARE), oncology supportive care to reduce radiation therapy toxicity and sensitize tumors, and inflammatory lung diseases including COVID-19 and idiopathic pulmonary fibrosis (IPF).
Is Humanetics Corporation a public or private company?
Humanetics Corporation is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Humanetics Corporation founded?
Humanetics Corporation was founded in 2012. It employs 11 to 50 people.
Where is Humanetics Corporation based?
Humanetics Corporation is headquartered in Minneapolis, United States, in the North America region.
How does Humanetics Corporation make money?
One revenue line is on record: pre-revenue / Clinical Stage.
Who are Humanetics Corporation's main competitors?
Direct peers on record are Galera Therapeutics, Soligenix, Partner Therapeutics and Cellerant Therapeutics. Emerging players are BioMimetix Pharmaceuticals, Aeolus Pharmaceuticals, Cara Therapeutics and Pliant Therapeutics. Humanigen is listed as an others. Amgen is listed as a broad incumbent.
Does Humanetics Corporation have an API?
No public API is recorded for Humanetics Corporation.
What industry is Humanetics Corporation in?
Humanetics Corporation's product category is Radiation Countermeasure Pharmaceuticals. Its primary akta.pro industry code is HLAKAFAC, Radiation Oncology. Its NAICS code is 325411 and its SIC code is 2834.