Trocar Pharma · RadShield™ (YK-4-250)

The first therapy for the radiation injury that medicine has never been able to treat

  • $1.5M bridge open now — rolling closings inside 60 days
  • FDA Pre-IND complete — Animal Rule pathway confirmed
  • 88% survival at 14.3 Gy vs. 58% control in DoD/AFRRI studies
  • $4.5M+ in DoD/AFRRI preclinical funding already deployed
  • Georgetown exclusive license No. 2022-0493 secured
  • Zero FDA-approved therapies for early lethal ARS
$1.5M Bridge · $100,000 Average Investment|Reg D 506(c) · Verified Accredited Only
$1.5M
Bridge Open Now
88%
Survival @ 14.3 Gy
$0
Approved GI-ARS Rivals
$67.5B
Global TAM

The raise

$1.5M now. $25M next. $50M to procurement.

Trocar is raising capital in three sequenced tranches so every dollar is matched to a milestone. The immediate $1.5M operating bridge is open to verified accredited investors with rolling closings inside 60 days; the follow-on tranches open as the work it funds is completed.

Tranche 1 · Open now

$1,500,000

Operating Bridge

Reopens and scales operations, rebuilds the full-time team, and completes the product-development and regulatory work required to enter the next financing from strength.

Exemption
Reg D Rule 506(c) · verified accredited investors
Timing
Rolling closings within 60 days
Security
Convertible note or preferred equity
Check size
$100,000 average investment

Tranche 2 · Follow-on

$25,000,000

IND Enablement

Funds GLP toxicology, cGMP API synthesis and formulation, the CMC package, and the IND submission under the confirmed Animal Rule pathway.

Exemption
Reg D private placement · accredited only
Timing
Opens after bridge milestones are met
Security
Preferred equity
Check size
$250,000 average investment

Tranche 3 · Follow-on

$50,000,000

Clinical & Procurement

Carries RadShield through Phase 1/2 human safety, pivotal animal efficacy studies, and pre-positioning for Strategic National Stockpile and DoD procurement.

Exemption
Reg D private placement · accredited only
Timing
Opens on IND clearance
Security
Preferred equity
Check size
$250,000 average investment

Tranche sizing, sequencing and timing reflect Trocar's current capital plan. Final security terms for each tranche are set with securities counsel and are described in full in the offering documents.

Watch before you invest

Sixty years of searching. Zero approved treatments.

A short briefing on RadShield™, the GI-ARS survival gap, and why Trocar is positioned to fill it under the FDA Animal Rule.

Traction

Government-validated data, secured IP, and a confirmed FDA pathway

In a category defined by decades of failed candidates, Trocar's progress is documented by federal research partners, an executed university license, and a completed Pre-IND meeting.

88%

Survival at a lethal dose

88% survival vs. 58% control at 14.3 Gy in DoD/AFRRI GI-ARS studies — a 30%+ improvement at a highly lethal exposure.

$4.5M+

DoD / AFRRI funding

Independent, government-validated preclinical efficacy data generated with federal research dollars, not company money.

Pre-IND

FDA meeting completed

Animal Rule (21 CFR §314.610) pathway confirmed — approval without a human efficacy trial.

4

U.S. patents

Composition, dose optimization, formulation, and combination therapy — 15+ years of protection from filing.

13+

Pipeline indications

Oncology support, hypertension, NASH, inflammatory disease, Alzheimer's and viral infection — $100B+ of added TAM.

NIH

Grant 1U01AI187033-01

Active award with a priority score of 30, alongside a Congressional letter of support from Rep. Steny Hoyer.

The science

Halting the cascade that makes radiation lethal

Above 6–7 Gy, death is driven by Gastrointestinal ARS: intestinal barrier breakdown, bacterial translocation, sepsis, and multi-organ failure. Legacy countermeasures address bone marrow injury only. RadShield targets the GI survival window directly.

RadShield oral capsule in United States flag livery

01

Dual Mechanism of Action

Angiotensin receptor I blockade paired with targeted ROS quenching — the combination that separates RadShield from single-pathway candidates.

02

Stem Cell Regeneration

Activates intestinal crypt stem cell proliferation, accelerating repair of radiation-damaged epithelium.

03

Cytokine Suppression

Blocks the pro-inflammatory cascades (IL-1β, TNF-α, IL-6) that drive intestinal barrier failure.

04

Oxidative Stress Control

Antioxidant activity reduces reactive oxygen species across the GI mucosa after exposure.

Result: barrier integrity is preserved, bacterial translocation is prevented, and the lethal cascade is halted.

Compound
YK-4-250
Patented DIM analog
Route
Oral
Stockpile and field deployable
Window
24 Hours
Post-exposure administration
Target
GI-ARS
8–13 Gy lethal exposure band
Toxicity
No DLTs
In pharmacology studies to date
Pathway
Animal Rule
21 CFR §314.610 confirmed
Format
Tablet / Suspension
Administered by non-clinical personnel
Pricing
$1,500–$6,000
Per treatment course

Market

$67.5B global TAM across four procurement verticals

RadShield is a single molecule with four independent buyers — defense readiness, civilian preparedness, space exploration, and oncology supportive care — which diversifies commercial risk away from a single indication.

Near-term

Defense Readiness

1.3M+ active duty personnel require a deployable post-exposure countermeasure. BARDA, DTRA and DoD stockpile authority in scope.

Mid-term

Civilian Preparedness

FEMA / DHS nuclear incident response stockpiling for 340M+ U.S. civilians, with SNS procurement eligibility.

Mid / Long

Space Exploration

NASA and commercial astronaut health protocols for lunar, Mars and deep-space missions beyond low Earth orbit.

Long-term

Oncology Support

GI protection adjunct across 650,000+ annual radiation therapy courses where GI injury limits therapeutic dosing.

National strategic stockpile warehouse of emergency medical countermeasures

10-year revenue modeling

$12.4B

Base

$36.65B

Mid

$67.5B+

Upside

Cumulative projections across all four verticals using validated penetration assumptions and government-grade pricing. Projections are illustrative, not a forecast of results.

Why now

The buyer, the pathway, and the data all exist. The product has never existed — until now.

01

Government pull is already funded

$4.5M+ in DoD/AFRRI preclinical funding and an active NIH award (1U01AI187033-01, priority score 30) mean the efficacy data was generated and validated by the eventual buyer.

02

The regulatory path is confirmed, not hoped for

The FDA Pre-IND meeting is complete and the Animal Rule pathway is confirmed — approval does not require a human efficacy trial in the lethal exposure setting.

03

First-mover in an empty category

No FDA-approved therapy exists for early lethal ARS. AEOL-10150 and Ex-RAD are injection-based without GI-specific data; BIO 300 addresses hematopoietic ARS only.

04

Procurement authority already exists

Project BioShield, BARDA, DTRA and Strategic National Stockpile authority create a defined buyer with appropriated budget, plus a Congressional letter of support on file.

Roadmap

IND by Q3 2027, Phase 1/2 through 2029, procurement from 2030

The $1.5M bridge reopens and scales operations now. The $25M follow-on funds GLP toxicology, cGMP manufacturing and the IND. The $50M follow-on carries RadShield through Phase 1/2 and into procurement readiness.

  1. Q4 2026

    GLP Toxicology Initiated

    • Repeat-dose toxicology in rat and mini-pig models
    • Close Series A with rolling closings from a $5M minimum
    • Stand up BARDA BAA pursuit and government capture team
  2. Q1 2027

    cGMP Manufacturing

    • API synthesis at commercial-intent scale
    • Formulation development completed
    • CMC package assembled for IND filing
  3. Q3 2027

    IND Submission

    • FDA IND submitted under the confirmed Animal Rule pathway
    • 30-day clearance target; Phase 1 and CMC run concurrent
    • Strategic licensing discussions activated on filing
  4. 2028–2029

    Phase 1/2 Execution

    • Human safety with surrogate efficacy endpoints
    • Pivotal animal efficacy studies under the Animal Rule
    • SNS and DoD procurement pre-positioning
  5. 2030+

    NDA & Procurement

    • NDA submission supported by AFRRI and animal efficacy data
    • Government procurement negotiations under stockpile authority
    • Pipeline expansion into the 13+ secondary indications

Use of proceeds — $1.5M bridge

Core Payroll & Benefits

$450K · 30%

Rebuild the full-time operating team

Product / CMC Completion

$450K · 30%

Technical work to complete the lead development milestone

Regulatory / Quality / Clinical Planning

$225K · 15%

Regulatory consultants, quality systems, protocol planning

Lab / Preclinical Studies

$150K · 10%

External research, testing and data package work

Legal / Financing / Compliance

$75K · 5%

Corporate, securities and offering compliance

Business Development / IR

$75K · 5%

Strategic partnerships and investor communications

Contingency / Working Capital

$75K · 5%

Timing buffer, vendor deposits, operational reserve

Team

The inventor, the oncology operator, and the process chemist who scaled Januvia

Trocar's leadership pairs the scientist who discovered YK-4-250 with executives who have run an NCI-designated cancer center, led cross-border investment banking, and taken an API from research to commercial manufacture.

Milton L. Brown, MD, PhD, FNAI

Co-Founder, Chairman & CEO

Discovered YK-4-250. MD (Virginia) and PhD in synthetic chemistry (UAB). Founding director of Georgetown's Drug Discovery Program; co-founder of Nasdaq-listed Shuttle Pharmaceuticals (SHPH).

Donald L. "Skip" Trump, MD, FACP

Clinical Development & Oncology

President of Roswell Park Comprehensive Cancer Center 2007–2014; now CEO of the Inova Schar Cancer Institute. Johns Hopkins-trained, nationally recognized in GU oncology.

Damian V. Dolland

Co-Founder

Former Executive Director, Investment Banking at Morgan Stanley and COO of its Inclusive Ventures Group; previously Head Managing Director, Sub-Sahara Investment Banking at JP Morgan India.

Joseph D. Armstrong III, PhD

CMC Advisor

Two decades in Merck Process Research. Led the team that developed the commercial API manufacturing process for Januvia (sitagliptin).

Melissa Brooks, CPA

Chief Financial Officer

25+ years in accounting and financial management, beginning at PricewaterhouseCoopers. Oversees financial operations, controls and compliance.

Joy Hinton, Esq.

General Counsel

Regulatory, securities and transactional counsel, working alongside Covington & Burling LLP and Akin Gump Strauss Hauer & Feld LLP.

Investment terms

$1.5M bridge open now · $25M and $50M follow-on tranches to come

The immediate bridge is offered under Reg D Rule 506(c) to verified accredited investors, with rolling closings so capital reaches operations before the round is fully subscribed.

Issuer
Trocar Pharma, Inc. (Maryland C-Corporation)
Current Offering
$1,500,000 operating bridge — open now
Structure
Reg D, Rule 506(c) — verified accredited investors only
Security
Convertible note or preferred equity (final terms set with counsel)
Average Investment
$100,000 · smaller allocations considered case by case
Closing
Rolling closings so capital funds operations before full subscription
Timing
60-day subscription window from launch
Verification
Third-party accreditation verification required under 506(c)
Escrow
Funds held in third-party escrow pending closing conditions
Follow-On 1
$25,000,000 — IND enablement, opens on bridge milestones
Follow-On 2
$50,000,000 — Phase 1/2 and procurement readiness, opens on IND clearance
Bridge Investor Priority
Bridge participants are offered allocation in both follow-on tranches

Diligence

Offering documents

Materials are provided for qualified accredited investors. Additional diligence — audited financials, the Georgetown License Agreement, DoD/AFRRI study summaries and the Sole Source Justification Memorandum — is released on execution of an NDA.

FAQs

Questions investors ask first

What exactly is RadShield™?

RadShield (YK-4-250) is a patented small-molecule diindolylmethane (DIM) analog developed as a first-in-class oral mitigator of Gastrointestinal Acute Radiation Syndrome. It is administered after exposure, within a 24-hour therapeutic window.

Why is there no approved competition?

Existing countermeasures address hematopoietic (bone marrow) ARS. AEOL-10150 and Ex-RAD are IV/injection-based with no GI-specific efficacy data, and BIO 300 addresses hematopoietic ARS only. There are zero FDA-approved therapies for the early lethal GI effects of radiation exposure.

How can approval happen without human efficacy trials?

The FDA Animal Rule (21 CFR §314.610) exists for threats that cannot ethically be studied in humans. Trocar completed a Pre-IND meeting and the FDA confirmed this pathway. Human trials are still required for safety; efficacy is established in well-characterized animal models.

Who owns the intellectual property?

Trocar holds Georgetown University Exclusive License No. 2022-0493, executed June 29, 2022, granting exclusive global commercial rights to RadShield and the YK-4-250 platform, plus four U.S. patents covering composition, dosing, formulation and combination therapy.

How much is Trocar raising right now?

Trocar is raising an immediate $1,500,000 operating bridge under Reg D Rule 506(c), with rolling closings inside a 60-day window. Two follow-on tranches — $25,000,000 for IND enablement and $50,000,000 for Phase 1/2 execution and procurement readiness — open as milestones are met.

What is the typical investment size?

The bridge is modeled on a $100,000 average investment; the follow-on tranches are modeled at $250,000. All purchasers must be accredited, and 506(c) requires third-party verification of accredited status — self-certification alone is not sufficient.

How are the bridge proceeds deployed?

30% core payroll to rebuild the full-time team, 30% product and CMC completion, 15% regulatory, quality and clinical planning, 10% lab and preclinical studies, 5% legal and compliance, 5% business development and investor relations, and 5% contingency and working capital.

Do bridge investors participate in the follow-on rounds?

Yes. Bridge participants are offered allocation in both the $25M and $50M follow-on tranches, and the bridge security is structured to convert into the next qualified financing on terms set with securities counsel.

What are the principal risks?

This is a clinical-stage pharmaceutical company. Preclinical results may not translate, regulatory timelines can extend, government procurement is not guaranteed, and the securities are illiquid with no public market. Investors may lose their entire principal. Review the PPM in full.

How do I get the full data room?

Qualified accredited investors execute an NDA and investor suitability form, after which the PPM, audited financials, the Georgetown license agreement, DoD/AFRRI study summaries and the Sole Source Justification Memorandum are released.

Trocar Pharma shield mark

Request access

The $1.5M bridge is open now

Offer materials are released under NDA to accredited investors, verified as required under Reg D Rule 506(c). The bridge is modeled on a $100,000 average investment with rolling closings inside 60 days, followed by $25M and $50M tranches as milestones are met.

Or call 702-929-9226 · Bridge closes within 60 days