Adaptin Bio, Inc.

Company overview

• Website: www.adaptinbio.com
• Principal office: 3540 Toringdon Way, Suite 200, #250, Charlotte, NC 28277
• Primary objective: Develop and commercialize products that improve delivery of drugs and other compounds to the brain and other tissues for cancer and other indications using novel delivery technology.
• Tech origin: Technology developed at Duke University and licensed by the company in 2023.
• Public company status: Emerging growth company and smaller reporting company under the JOBS Act and Exchange Act definitions; may qualify for certain reporting exemptions while an emerging growth company.

Corporate history

• Merger: On February 11, 2025, Adaptin Bio, Inc. completed the business combination among Unite Acquisition 1 Corp., Adaptin Acquisition Co. (Merger Sub), and Adaptin Bio Operating Corporation. After the merger, Unite Acquisition 1 Corp. changed its name to Adaptin Bio, Inc.
• Post-merger: The company now operates as Adaptin Bio, Inc. with leadership and operations resulting from the merger.

Business focus and technology

Core platform — BRiTE (Brain Bispecific T-cell Engager)

• Purpose: Transport difficult-to-deliver therapeutic agents across the blood-brain barrier to the brain and other tissues, enabling targeted immunotherapy and delivery for CNS and other conditions.
• Mechanism: Combines a brain-targeting delivery approach with activated T cells to redirect immune activity to disease sites behind the blood-brain barrier.

Lead candidate — APTN-101

• Composition: EGFRvIII x CD3 BRiTE bispecific T-cell engager.
• Target: Tumors expressing EGFRvIII (a mutated form of EGFR).
• Indication focus: Glioblastoma multiforme (GBM) and other EGFRvIII-expressing tumors, including breast and lung cancers with or without brain metastases.
• Development status:
  • IND accepted for an investigator-initiated, single-dose Phase 1 study (May 2023).
  • IND amendment for a multi-dose Phase 1 accepted (October 2025).
  • IRB approvals for the multi-dose trial obtained (March 2026).
  • Proposed Phase 1 site: Duke University’s Preston Robert Tisch Brain Tumor Center.
• Trial objectives: Assess safety and tolerability of BRiTE alone and with activated polyclonal T cells; characterize pharmacokinetics (PK); and explore pharmacodynamics, anti-BRiTE antibodies, overall survival, and progression-free survival.
• PK/PD plans: Population PK analysis using NONMEM; exploratory analyses for pharmacodynamics and immune response.

Clinical development plan

• Plan to initiate preclinical and early clinical studies on additional candidates and indications beginning around 2027, subject to capital and strategic considerations.

Intellectual property and research agreements

• Primary license: Exclusive license from Duke University related to BRiTE technology and related bispecific EGFRvIII antibody engaging molecules and enhanced delivery of drugs to the brain and other tissues (the “Duke License”). Rights include bispecific EGFRvIII antibody engaging molecules, human bispecific EGFRvIII x CD3 engaging molecules, and certain improved variants.
• Obligations: Company must use commercially reasonable efforts to obtain and retain regulatory approvals and to commercialize licensed products; the license includes milestone and royalty obligations.
• Sponsored research agreements:
  • 2024 Sponsored Research Agreement (assumed pursuant to the merger) for BRiTE administration methods.
  • 2025 Sponsored Research Agreement for GMP manufacturing procedures for the APTN-101 BRiTE product.
• Equity and financial terms with Duke:
  • Duke received shares equal to 5% of the company’s then-issued and outstanding common stock on a fully diluted basis; post-merger and subsequent issuances, Duke owns approximately 1.2% of the company’s fully diluted shares.
  • Milestones: Potential total milestone payments of approximately $11.7 million tied to development and regulatory events.
  • Royalties: Running royalties in the low- to mid-single-digit percentages of annual net sales, with a potential downward adjustment to low single digits if no valid patent claim applies; sublicensing royalties to Duke in the low- to mid-double-digit percentages.
  • Reimbursements: Company reimburses Duke for patent expenses; amounts identified include approximately $327,000 incurred before the license and additional patent-related costs (~$31,000 in 2024 and ~$55,000 in 2025).
  • Term: License remains in effect until expiration of the last-to-expire patent rights; early termination provisions apply.

Patent position

• Company holds a worldwide exclusive license to three issued/allowed U.S. patents and one PCT patent application covering enhanced brain and tissue delivery.
• Patents underlying the license have terms that run from 2031 to 2039 (without patent term extensions).
• The company is pursuing additional patents and licenses related to BRiTE technology and its uses.

Manufacturing and supply

• Manufacturing model: Outsourced to contract manufacturing organizations (CMOs); the company does not own manufacturing facilities.
• Capabilities: Produced clinical-grade BRiTE for APTN-101 with a master cell bank and scalable purification and formulation processes suitable for clinical translation.
• Sourcing: Relies on CMOs on a fee-for-services basis and may secure backup or longer-term manufacturing arrangements as programs advance.
• Compliance: Vendors operate under current Good Manufacturing Practices (cGMP).

Market and competition

• Industry context: Operates in a competitive pharmaceutical and biotech landscape with active development of immunotherapies and CNS-targeted delivery technologies.
• Potential competitors: Context Therapeutics, Vir Biotechnology, Janux Therapeutics, Amgen, and Genentech (Roche) among others; some competitors are developing immune cell engagers or EGFRvIII x CD3 bispecifics using different approaches.
• Competitive focus: Success will depend on identifying, developing, and managing a portfolio of safe and effective products that address unmet needs, particularly for brain cancers.

Regulation and reimbursement

• Regulatory pathway: Subject to FDA processes for preclinical testing, INDs, clinical trials, NDA submission, advisory committee review as applicable, facility inspections, and post-approval surveillance.
• Expedited programs: Plans to pursue Fast Track, Breakthrough Therapy, and Orphan Drug designations where applicable.
• Reimbursement: Company acknowledges uncertainty in third-party payer coverage and may pursue cost-effectiveness analyses and payer-specific strategies.

Employees and facilities

• Employees: Four employees as of December 31, 2025; all located in the United States.
• Labor: No employees represented by a labor union or covered by a collective bargaining agreement.
• Office space: Principal executive office operates on a month-to-month lease; current space includes mail services and shared meeting areas.
• Office address: North Carolina location; rent approximately $100 per month.

Additional information

• Public filings: The company states that information on its website is not part of reported filings; SEC filings are available on the SEC website and the company website.
• Litigation: The company reports no pending legal proceedings of which it is aware.
• Cybersecurity: The CFO oversees cybersecurity with support from third-party providers; managed IT and security measures are in place.