# Tolera Bio — Financial Model & Value-Inflection Plan
*Confidential — for VC / VP discussion. Planning model for a Seed-stage company; not guidance.*

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## The ask

**Raising a $8M Seed round** to take the PACT platform from validated design to a **cleared IND and first-in-human dosing**, plus stand up the companion diagnostic. This is the capital that converts computational designs into human-validated, IND-enabling data — the single largest de-risking step available at this stage.

A **$35M Series A** then funds Phase 1 through the **Phase 2 proof-of-concept** (durable histologic remission off-therapy) — the value inflection that supports partnering or a Series B at a materially stepped-up valuation.

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## Seed — $8M use of proceeds (→ IND + start FIH; 18–30 mo runway)

| Category | $M | What it buys |
|---|---|---|
| Human functional validation (Tier-A/B cassettes) | 1.1 | Converts computational priors → validated cassettes; proof-of-mechanism |
| Murine proof-of-concept efficacy | 1.0 | In vivo tolerance/efficacy signal |
| GLP toxicology & NP biodistribution | 1.6 | Safety package for FIH |
| GMP process development & IND lots | 1.9 | The individualized-manufacturing control strategy |
| Companion diagnostic development (CLIA) | 0.7 | Patient-selection assay + standalone product |
| Regulatory (ODD, INTERACT, pre-IND, IND) | 0.5 | Designations + FDA alignment + filing |
| Team & G&A | 1.2 | Core scientific + ops team, runway |
| **Total** | **8.0** | **Cleared IND + first-in-human dosing** |

## Series A — $35M use of proceeds (→ Phase 2 PoC)

| Category | $M |
|---|---|
| Phase 1 (FIH safety + antigen-specific PD) | 9.0 |
| Phase 2 PoC (durable remission off-therapy) | 14.0 |
| GMP scale-up & individualized-release automation | 5.5 |
| CDx clinical validation & submission | 2.5 |
| Platform expansion (2nd indication: celiac) | 2.0 |
| Team scale & G&A | 2.0 |
| **Total** | **35.0** |

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## Value-inflection milestones (see timeline figure)

| Milestone | ~Month | De-risking delivered |
|---|---|---|
| Seed close | 0 | Company formed; capital in |
| Orphan Drug Designation | 1–3 | Exclusivity + early credibility |
| Functional validation (Tier-A) | 9–15 | Mechanism de-risked in human cells |
| Murine PoC | 12–20 | In vivo efficacy signal |
| Pre-IND alignment | 15–20 | FDA endpoint + CMC agreement |
| **IND cleared** | 24–33 | **Cleared to dose humans — major value step-up** |
| Series A close | 30–33 | Financed to PoC |
| First-in-human (Phase 1) | 33–42 | Human safety + antigen-specific PD |
| Breakthrough Therapy filing | 40–44 | Expedited status |
| **Phase 2 PoC: durable remission** | 48–62 | **THE value inflection — partnering / Series B** |

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## The return logic for investors

- **Category-defining asset** in a ~$2B unmet-need market with no antigen-specific competitor.
- **Platform, not a single molecule:** PACT extends to celiac and other food/auto-antigen disease — multiple shots on goal from one engine.
- **Capital-efficient path to inflection:** ~$8M to IND/FIH, ~$43M cumulative to a Phase 2 PoC that supports pharma partnering.
- **Two revenue lines:** therapeutic + companion diagnostic (the latter can generate revenue earlier and independently).
- **Orphan economics:** 7-year exclusivity, expedited designations, premium value-based pricing justified by displaced lifelong-biologic cost.

*Dollar figures are Seed-stage planning assumptions and will be refined with FDA interactions, manufacturing quotes, and clinical-site costs. All non-dairy epitope activity remains a computational prior pending wet-lab validation.*