# Affini-T Financial Model

Engineered T cell therapies targeting oncogenic driver mutations (KRAS, p53) in hard-to-treat solid tumors

- Canonical: https://finamodel.com/startups/affini-t
- Excel download: https://finamodel.com/startup-models/affini-t.xlsx
- Category: Biotech/Pharma
- Model type: Biotech rNPV
- Funding round: Series B
- Funding: $175M
- Founded: 2022
- Geography: US-headquartered (Boston HQ + Seattle research lab); global market ambition (US, EU, China incidence cited)
- Customer: B2B2C

## About the company

Affini-T develops engineered T-cell therapies against oncogenic driver mutations including KRAS G12V, KRAS G12D, mutant p53, and MCPyV. Its platform combines T-cell receptor discovery with lentiviral engineering and a Fas-41BB survival switch intended to turn a tumour death signal into a survival signal.

The approach coordinates CD4 and CD8 responses to reduce T-cell exhaustion in immunosuppressive tumour environments and targets mutations present in every cancer cell. Its pipeline progresses from lentiviral programmes through gene editing, synthetic biology, and potential allogeneic or in-situ therapies.

This is a preclinical biotech with no product revenue. Multiple KRAS candidates, manufacturing processes, gene-editing strategy, and facilities are reported as advanced, backed by VIDA Ventures and Leaps by Bayer. The model should stage R&D, manufacturing, trials, probability-adjusted milestones, partnerships, and cash runway.

## What's included

- 5-year monthly revenue build with stage-appropriate growth assumptions
- Full P&L, headcount plan, and operating-expense schedule
- Cash-flow statement, runway, and burn-rate tracking
- Valuation via exit multiple with a DCF cross-check
- Returns analysis with MOIC and IRR
- Unit economics including CAC, LTV, payback, and cohort retention

## Product & value proposition

- Platform: TCR (T cell receptor) discovery + lentiviral engineering of patient T cells; proprietary Fas-41BB survival switch converts tumor death signal to survival signal
- Coordinated CD4+/CD8+ T cell response - CD4 helper cells prevent CD8 exhaustion and sustain anti-tumor activity in immunosuppressive TME
- Targets oncogenic driver mutations present in every cancer cell (KRAS G12V, KRAS G12D, Mutant P53, MCPyV) - mutations cannot be easily lost, minimising escape mechanisms
- Differentiator vs. approved KRAS inhibitors (e.g., LUMAKRAS/sotorasib): covers G12V and G12D subtypes where no approved therapies exist; avoids tumour escape via cell-intrinsic mechanism
- Pipeline architecture: 1st-Gen (lentiviral + switch) → 2nd-Gen (gene edits) → 3rd-Gen (synthetic bio) → 4th-Gen (allo, in situ)

## Market

Three primary oncology markets cited, 2021 global figures:

| Indication | Market Size | CAGR | KRAS prevalence |
| -- | -- | -- | -- |
| Pancreatic cancer | $2.6B+ | 7.5% | KRAS 86%, P53 53%, PIK3CA 4% |
| Colorectal cancer | $12.1B+ | 4.9% | KRAS 41%, P53 55%, PIK3CA 16% |
| Lung cancer | $6.9B+ | 6.7% | KRAS 35%, P53 41%, PIK3CA 4% |

Combined addressable market (3 indications): ~$21.6B+

Annual incidence (US + EU + China, newly diagnosed, 2021):
- KRAS G12V: Pancreatic ~74K, Colorectal ~98K, Lung ~40K
- KRAS G12D: Pancreatic ~92K, Colorectal ~128K, Lung ~30K
- Global bubble chart incidence nodes: 60K, 106K, 149K, 235K, 370K, 393K, 555K, 124K, 815K (geographic distribution, tumour types not all individually labelled)

## Revenue model

Non-dilutive partnerships cited as a future Series A/B milestone.

## Traction & metrics

No revenue. Preclinical traction only:
- Multiple KRAS candidates advanced
- Manufacturing process established
- Gene editing strategy developed
- Facilities contracted
- Dozen-plus T cell therapeutic candidates advanced through Fred Hutch co-founders' prior work
- Published peer-reviewed data: WT1 TCR gene therapy (Chapuis et al., Nat Med 2019); PDAC T cell therapy (Stromnes et al., Cancer Cell 2015); Fas-41BB switch survival data (Oda et al., JEM 2020)
- Seed investors: VIDA Ventures, Leaps by Bayer, Humboldt, Agent Capital, Alexandria

## Competition / moat

- LUMAKRAS (sotorasib) approved only for KRAS G12C - Affini-T targets G12V and G12D where no approved therapies exist
- Scientific moat: Fred Hutch co-founders (Phil Greenberg MD, Aude Chapuis MD, Tom Schmitt PhD) with >12 T cell clinical programs; SAB includes Jim Allison PhD (Nobel laureate), Pam Sharma MD/PhD, Rafi Ahmed PhD, David Kranz PhD, Susan Kaech PhD
- Platform differentiation: proprietary TCR discovery + Fas-41BB switch + CD4/CD8 coordination - multi-layer vs. single-modality competitors
- Prior institutional relationships: Juno Therapeutics, NIH NCI, Fred Hutch, Bluebirdbio

## Team & funding ask / use of funds

Management:
- Jak Knowles MD - CEO (ex-CytoSen, Century, Exonics, Bayer)
- Loïc Vincent PhD - CSO (ex-Takeda, Sanofi, Endotis Pharma, Adaptate)
- Kim Nguyen PhD - CTO (ex-Precision, Vitalant, Terumo)
- Kathy Yi MBA - COO/CFO (ex-Cerevel, Sangamo, Novartis)

Funding ask: Not explicitly stated in deck (J.P. Morgan conference format - Series A implied as next round)

Use of funds (inferred from roadmap milestones, Series A/B phase):
- KRAS G12V + G12D: First-in-human safety studies
- Clinical readout for MCC (Merkel Cell Carcinoma) and KRAS
- p53 and PIK3CA clinical candidates
- Automated TCR discovery engine
- Non-viral manufacturing + next-gen synthetic biology
- Non-dilutive partnerships

Infrastructure: 95,000 sq.ft. Boston cGMP clinical and commercial manufacturing facility contracted

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## Recommended financial model

- **Archetype + why:** Clinical-stage biotech R&D burn / pipeline NPV model. Affini-T is pre-IND, pre-revenue, with multiple programs across discovery and preclinical stages. The appropriate model is a **program-by-program R&D spend and milestone timeline model**, with a probability-weighted NPV (rNPV) overlay for each pipeline asset as a terminal value proxy. This is the standard VC/biotech framework - no revenue forecasting until Phase 2 readout assumptions.

- **Forecast horizon & granularity:**
  - Near-term operating model: 2022–2026 (annual), quarterly detail for 2022–2023
  - Pipeline NPV: per-program horizon to peak sales (2030–2035), discounted at biotech-standard 10–15% WACC
  - Milestone timeline driven by slide 23 roadmap: Seed (2021 complete) → Series A/B (2022–2023) → Clinical POC (2023+)

- **Key drivers & assumptions:**

  *Burn / operating cost drivers:*
  - Headcount ramp: ~30–50 FTEs at Seed; double to ~80–120 at Series A close, driven by bi-coastal build-out
  - Avg. fully-loaded cost per FTE: ~$200K–$250K/yr (Boston biotech market)
  - R&D spend per program per year in preclinical: ~$3M–$8M (cell therapy process dev + manufacturing costs)
  - IND-enabling / Phase 1 per program: ~$10M–$25M (autologous cell therapy trials are cost-intensive; patient leukapheresis, manufacturing, clinical sites)
  - cGMP facility build-out: 95,000 sq.ft.; capex ~$50M–$100M (phased; typical for cGMP cell therapy)
  - Manufacturing COGS per patient dose (autologous): ~$150K–$350K (analogous to CAR-T; Affini-T proprietary Lentiviral + Switch process may differ)

  *Pipeline program timing (from roadmap):*
  - KRAS G12V (HLA-A11): Lead program, furthest in discovery → preclinical; FIH in 2022–2023
  - KRAS G12D (HLA-A11): Discovery/preclinical stage
  - Mutant P53 (HLA-A2): Early discovery
  - MCPyV (Viral driver, HLA-A2): Discovery → clinical stage implied

  *Revenue assumptions (if modelling peak sales for NPV):*
  - Therapy price per patient: ~$400K–$500K per infusion (consistent with approved CAR-T pricing: Kymriah $475K, Yescarta $373K)
  - Addressable patients per program per year (US+EU+China): KRAS G12V pancreatic ~74K total incidence; apply ~2–5% treatment penetration in early years
  - Probability of success (PoS) per stage: Discovery→Preclinical 60%; Preclinical→Phase 1 50%; Phase 1→Phase 2 40%; Phase 2→Approval 30% (cell therapy oncology historical benchmarks)
  - Royalty / partnership split: 10–20% royalty on ex-US sales if non-dilutive partnership executed

  *Market size validation:*
  - Pancreatic: $2.6B+ market, 7.5% CAGR
  - Colorectal: $12.1B+ market, 4.9% CAGR
  - Lung: $6.9B+ market, 6.7% CAGR

- **Scenarios (Base / Bull / Bear - which variables flex):**
  - **Bear:** KRAS G12V Phase 1 safety signal delays; 2nd program (G12D) pushed 2 years; cGMP cost overruns +30%; PoS halved vs. base; requires Bridge/Series B extension
  - **Base:** KRAS G12V achieves FIH 2023; G12D Phase 1 by 2024; Series A raises ~$80–120M; clinical POC 2025–2026; peak sales KRAS G12V ~$600M–$1B (US+EU)
  - **Bull:** Accelerated IND filing; multiple FIH readouts 2023–2024; non-dilutive partnership deal (upfront + milestones $50–200M); allo/in situ platform unlocks broader market; KRAS peak sales >$1.5B

- **Required sheets / outputs:**
  1. **Assumptions** - all drivers in one input sheet (toggle switches by scenario)
  2. **Headcount & Opex** - department-level burn by quarter (R&D, G&A, Clinical Ops, Manufacturing)
  3. **Pipeline Timeline** - Gantt-style program progression by asset with IND/Phase 1/2 dates
  4. **Cash Runway** - cumulative burn vs. available capital; breakeven/next raise trigger
  5. **rNPV per Program** - probability-weighted peak sales NPV per asset (KRAS G12V, G12D, p53, MCPyV)
  6. **Portfolio NPV Summary** - sum of rNPVs; sensitivity to discount rate and PoS
  7. **Financing Schedule** - Seed (complete), Series A (2022), Series B (2023–2024), IPO / partnering (2025+)
  8. **Scenario Dashboard** - Bear/Base/Bull NPV and runway side-by-side

## Frequently asked questions

### Is the Affini-T financial model free?

Yes. The Affini-T model is a free Excel download with live formulas.

### Can I change the assumptions?

Yes. The workbook is editable and its live formulas recalculate when assumptions change.