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- **Phase III Trials**: Prasinezumab and coramitug in Phase III; BMS-986446 Phase II completion in 2027.
- **$105M Milestones**: Potential 2026 payments from coramitug and PRX019.
- **CYTOPE Innovation**: TDP-43 targeting in ALS; PRX012-TfR reduces ARIA-E risk.
- **Financial Resilience**: $308.4M cash in 2025; 2026 ending cash of ~$255M.

**【CEO Summary Section】**
- Advanced prasinezumab and coramitug into Phase III trials; BMS-986446 Phase II completion expected in 2027.
- Potential $105M in 2026 milestones from coramitug and PRX019.
- CYTOPE technology shows promise in ALS, targeting TDP-43 aggregates.
- PRX012-TfR aims to reduce ARIA-E risk with once-monthly subcutaneous dosing.

**【CFO Financial Commentary】**
- 2025 net loss of $244.1M, ending cash of $308.4M.
- 2026 guidance: $50-55M net cash use, ending cash of ~$255M.
- Up to $105M in 2026 milestones, excluding royalties.

**【Q&A Key Highlights】**
- 2026 focus on CYTOPE data sharing and BMS-986446 Phase II results (2027).
- PRX012-TfR targets presymptomatic AD with lower ARIA rates.
- Engaged in research collaborations for CYTOPE applications.
- BMS to decide on PRX019 Phase II post-2026 Phase I results.

Prothena Corporation plc (PRTA) Q4 2025 Earnings Call Transcript

- **Birtamimab Pivotal Year:** Phase 3 AFFIRM-AL trial targeting 59% mortality risk reduction (VITAL trial p=0.021), with U.S. launch potential in H2 2026.
- **Alzheimer's Pipeline Expansion:** PRX012 Phase 1 data mid-2025, PRX123 Fast Track with IND cleared for Phase 1.
- **Commercial Ambition:** Birtamimab projected as multi-billion dollar opportunity with 2026 U.S. launch; Alzheimer's programs address underserved early/symptomatic AD markets.
- **Financial Strength:** $472M cash as of Dec 2024, well-capitalized for 2025 ($171.5M net cash use) with no debt.

**【CEO Opening Remarks】**
- Prothena's mission is to develop transformational therapies for protein dysregulation diseases, with a focus on neurodegenerative and rare peripheral amyloid diseases.
- 2025 is a pivotal year with key readouts for wholly-owned programs: birtamimab (AL amyloidosis), PRX012 (Alzheimer's), and PRX123 (dual A-beta/tau vaccine).
- Birtamimab Phase 3 AFFIRM-AL trial expected to report Q2 2025, with potential U.S. launch in H2 2026 if successful.

**【Chad Swanson - Clinical Updates】**
- **Birtamimab (AL amyloidosis):**
  - Confirmatory Phase 3 AFFIRM-AL trial randomized 2:1, with primary endpoint of time to all-cause mortality (p ≤ 0.10 for success).
  - VITAL trial showed 59% risk reduction in Mayo Stage IV patients (p=0.021), supporting SPA agreement with FDA.
  - Coramitug (ATTR-CM) Phase 2 signal detection trial by Novo Nordisk expected to report H2 2025.
- **Alzheimer's Portfolio:**
  - PRX012 Phase 1 ASCENT-2 trial evaluating safety and PK/PD in early AD patients, with mid-2025 data readout.
  - PRX123 dual A-beta/tau vaccine granted Fast Track designation, with IND cleared for Phase 1.

**【Brandon Smith - Commercial Strategy】**
- **Birtamimab Market Potential:**
  - U.S. diagnosed and treated AL amyloidosis patients: ~16,000 (13,000 with cardiac involvement).
  - Peak penetration expected in Mayo Stage IV patients (~5,000 U.S., 5,000 Europe), with multi-billion dollar global opportunity.
  - Launch strategy: focused sales force targeting amyloidosis centers of excellence.
- **Alzheimer's Pipeline:**
  - PRX012 positioned for early AD market with once-monthly subcutaneous administration.
  - PRX123 vaccine approach targeting presymptomatic and early symptomatic AD populations.

**【Tran Nguyen - Financial Performance】**
- **2024 Results:**
  - Net cash used: $150.3M (low end of $148-160M guidance).
  - Net loss: $122.3M (low end of $120-135M guidance).
  - Cash balance: $472.2M as of Dec 31, 2024.
- **2025 Guidance:**
  - Net cash used: $168-175M (midpoint $171.5M).
  - Ending cash: ~$301M (midpoint of $297-305M range).
  - Key driver: estimated net loss of $197-205M, including $41M non-cash SBC.

**【Q&A Highlights】**
- **Birtamimab Market Dynamics:**
  - 80% of AFFIRM-AL patients on daratumumab, but no impact on early mortality (ANDROMEDA trial p=0.0657).
  - High demand for anti-amyloid therapy with favorable safety profile in high-risk patients.
- **PRX012 Development:**
  - ASCENT-2 trial expansion cohort (200mg, ~100 patients) to better characterize PK/PD and safety in APOE4 homozygous carriers.
  - Long-term data from ASCENT-3 open-label extension to inform Phase 2 design.
- **Regulatory Pathway:**
  - FDA SPA agreement for birtamimab requires p ≤ 0.10 for BLA submission; European regulators expected to align on risk-benefit profile.

Actual												-0.59	-0.66	-0.77	-0.77	-0.91	0.58	2.13	-0.71	-0.78	-0.88	-0.97	0.12	-0.89	-1.03	0.38	-1.26	-1.34	1.22	-1.1	-1.08	-1.12	-2.34	-0.68	-0.4
Forecast												-0.5729	-0.615	-0.6517	-0.7686	-0.5683	0.9982	2.2636	-0.5837	-0.6913	-0.5232	-0.5851	-0.4658	-0.8706	-0.9328	-0.3228	-1.1756	-1.1575	-1.0589	-1.1675	-1.0233	-0.97	-1.2538	-0.6871	-0.5586
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	-2.98%	-7.32%	-18.15%	-0.18%	-60.13%	-41.90%	-5.90%	-21.64%	-12.83%	-68.20%	-65.78%	+125.76%	-2.23%	-10.42%	+217.72%	-7.18%	-15.77%	+215.21%	+5.78%	-5.54%	-15.46%	-86.63%	+1.03%	+28.39%

Actual	--	--	--	--	--	--	--	--	--	--	--	141.00K	195.00K	157.00K	360.00K	160.00K	60.07M	139.17M	1.17M	1.15M	1.31M	1.52M	49.92M	2.17M	4.02M	84.87M	316.00K	50.00K	132.01M	970.00K	2.12M	2.83M	4.42M	2.42M	21.00K
Forecast	--	--	--	--	--	--	--	--	--	--	--	171.43K	150.00K	160.83K	182.76K	8.68M	70.20M	140.05M	7.12M	8.09M	17.18M	25.22M	29.14M	8.60M	5.09M	41.69M	2.15M	2.17M	10.73M	1.35M	7.53M	11.45M	6.13M	6.64M	1.33M
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	-17.75%	+30.00%	-2.38%	+96.98%	-98.16%	-14.43%	-0.62%	-83.53%	-85.74%	-92.36%	-93.98%	+71.33%	-74.78%	-21.05%	+103.56%	-85.32%	-97.69%	+1130.59%	-27.97%	-71.82%	-75.30%	-27.89%	-63.62%	-98.43%

PRTA

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PRTA Q4 2025 Earnings

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You can ask Aime