Capability Statement · 2026

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Nightbox LLC

Computational biology · gene therapy · dual-use medical countermeasures
Wyoming-incorporated small business · NAICS 541714 · EIN 39-4373044

Legal name

Nightbox LLC

EIN

39-4373044

State of incorporation

Wyoming, United States (sole-member LLC)

Wyoming SOS Entity ID

2025-001768533

Operations address

Greater Los Angeles, California

Founded

February 2026

Primary NAICS

541714 — R&D in Biotechnology (except Nanobiotechnology)

Secondary NAICS

541715 (R&D Phys/Eng/Life Sci) · 325414 (Biological Product Mfg) · 541711 (R&D Biotech Nano)

PSC codes

AN15 (Biological R&D — Pharmaceuticals) · AN21 (Medical R&D)

Business size

Small business under SBA size standards (1 employee, ≤ $5M revenue)

Set-aside qualifications

SBA Small Business · pending SBC eligibility for SBIR/STTR upon SAM.gov UEI issuance

SAM.gov

Entity registration in progress (case INC-GSAFSD21007772) · UEI pending · CAGE pending

Bonding

Not currently bonded (R&D scope)

DUNS

N/A — DUNS retired April 2022; UEI used in lieu

Core competencies

Single-construct chimeric receptor-effector gene therapy design (NKG2D-LIF6 lead, AAV9 delivery, in silico complete)
AI-augmented R&D operating loop (production Anthropic SDK + AlphaFold3 + RoseTTAFold + custom prompt-router with NFKC normalization and 22-pattern injection scanner)
Computational pharmacogenomics and patient-anatomical-twin modeling (85-compartment dose prediction)
Freedom-to-operate scanning across patent corpora; competitive intelligence against named pipelines
Pre-IND regulatory pathway design (FDA CBER track), provisional patent drafting
Open-science publication of in-silico methods and code under CC BY 4.0

Differentiators

Manufacturing scalability — single-payload AAV9 vs autologous CAR-T processing; relevant to Strategic National Stockpile stockpileability
Clean intellectual-property whitespace on the lead chimera; provisional patent in flight
Solo-founder, low-overhead operating model — Phase 1-enabling work fits SBIR Phase I scope
Open methodology — primary references and design code public at github.com/nightbox-llc/chimera-design-notes
Air-gapped-capable companion software stack (NightboxOS, Pluely Stack) for SCIF-deployable AI inference

Past performance

No prior federal contract performance (founded February 2026). Fully bootstrapped through pre-IND program scope. Available for full and open and small-business set-aside competition under NAICS 541714. References and in silico validation package available on request.

Federal program alignment

NIH NCI SBIR Omnibus (PAR-25-279) — Phase I gene therapy oncology, Sept 5 2026 cycle
NIH NIAID SBIR (PA-25-301) — host-directed MCM track, dual-use
ARPA-H — Cancer Moonshot 2.0 + Resilient Systems portfolios
BARDA DRIVe — solid tumor immune modulation BAA-26-100-SOL-00007
DARPA BTO — Programmable Pharmaceuticals successor
In-Q-Tel — biosecurity dual-use, portfolio team
DTRA · JPEO-CBRND · ASPR — gene-therapy stockpileability angle

Key personnel

Artem Shakin — Founder, CEO, principal investigator. ORCID 0009-0006-0003-6806 · Wikidata Q139590669. Computational biology, AAV gene therapy construct design, AI-augmented research workflow. Greater Los Angeles, California.

Scientific Advisory Board: forming Q2 2026 (open seats: AAV gene therapy expert, ex-FDA CBER reviewer, tumor immunology PI, computational/structural biology PI). See /advisors.

Stage disclosure

All preclinical claims are in silico (computational predictions). No in vivo data, no human data, no peer-reviewed publication exists at the time of this statement. Wet-lab validation Q3–Q4 2026; pre-IND H2 2026; IND + Phase 1 first-in-human 2027 (subject to wet-lab validation).

Contact

Federal POC: Artem Shakin, Founder/CEO · federal@nightboxllc.com · artem@nightboxllc.com
Web: nightboxllc.com · ORCID: 0009-0006-0003-6806 · Wikidata: Q139590659