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- **CF Program Advancement:** 12-week Phase II study for ARCT-032 initiated with 10mg dose, targeting 20 patients with advanced endpoints (FEV1, LCI, HRCT).
- **OTC Regulatory Clarity:** Q1 2026 Type C meetings to define pivotal trials for adults and children with OTC deficiency.
- **Financial Strength:** $232.8M cash runway to Q2 2028, despite FY2025 revenue decline driven by LUNAR-COV19 transition.
- **Innovation Momentum:** ARCT-2304 flu vaccine shows durable immunity; STARR® platform validated for rare disease applications.

**【CEO Summary Section】**
- **ARCT-032 (CF Therapy):** Initiated a 12-week Phase II study in Q1 2026 with 10mg dose, evaluating safety and efficacy (FEV1, LCI, HRCT). Cohort 3 (15mg) showed no safety concerns. Enrollment includes U.S. and international sites targeting Class I CF mutations.
- **ARCT-810 (OTC Deficiency):** Scheduled Type C regulatory meetings in Q1 2026 to align on pivotal trial designs for adults and pediatric patients. Focus on reducing ammonia levels and improving quality of life.
- **Financials:** FY2025 revenue decreased 15.6% YoY ($70.3M) due to CSL collaboration wind-down. R&D expenses down 83% YoY ($83M) from LUNAR-COV19 transition. Cash runway extended to Q2 2028 ($232.8M as of Dec 2025).

**【Q&A Key Highlights】**
- **CF Study Design:** Optimized for stability (e.g., LCI over spirometry), 12-week duration to capture longer-term effects. 10mg dose selected based on early Cohort 2 signals; 15mg flexibility if needed.
- **OTC Regulatory Path:** Seeking clarity on endpoints for pediatric (severe outcomes) vs. adult (stable) populations. CSL's U.K. vaccine launch uncertain; U.S. approval challenges noted.
- **Vaccine Pipeline:** ARCT-2304 (pandemic flu) Phase I data shows durable immunity. STARR® platform validated for cell-mediated responses.

Arcturus Therapeutics Holdings Inc.(ARCT)-20260304-2025 Q4 Earnings call transcript

- **CF program momentum**: 30% mucus plug reduction in Phase II trial, with 20-patient enrollment targeted.
- **Financial stability**: $237M cash runway supports 2026 trials.
- **Collaboration continuity**: Meiji Pharma sales in Japan.

**【CEO Summary Section】**
- ARCT-032 program shows 30% mucus plug reduction in Phase II trial, with 12-week study planned for Q1 2026.
- ARCT-810 program targeting OTC deficiency, with regulatory meetings scheduled for Q1 2026.
- CSL collaboration in Japan continues with 1.1M doses sold in Q3.

**【CFO Financial Commentary】**
- Q3 2025 net loss of $13.5M vs $6.9M in Q3 2024.
- R&D expenses down 42% YoY to $23.3M.
- Cash runway extended to $237.3M.

**【Q&A Highlights】**
- 3.5M shares, 1.1M doses in Japan.
- 20-patient enrollment target for 12-week CF trial.
- CSL collaboration continues in Q4.

**【Q&A Key Highlights】**
- 15mg dose safety data to be shared Q1 2026.
- 20-patient enrollment target for 12-week study.
- Japan sales 1.1M doses Q3.


Arcturus Therapeutics Holdings Inc. (ARCT) Q3 2025 Earnings Call Transcript

- **Breakthrough CF Progress:** ARCT-032 Phase II interim data in September 2025 for Class I CF patients, targeting 3%+ FEV improvement with 280mg/28-day dosing.
- **OTC Biomarker Validation:** ARCT-810 Phase II data shows glutamine normalization and urea cycle function; FDA alignment on 15N-ureagenesis assay as endpoint.
- **Vaccine Pipeline Strength:** CoStave nearing global approvals; ARCT-2138 flu vaccine shows immunogenicity at low doses; ARCT-2304 bird flu vaccine on FDA Fast Track.
- **Financial Resilience:** $253M cash runway to 2028; R&D expenses down 49% YoY, extending runway for key therapeutics.

**【CEO Summary Section】**
- **ARCT-032 (CF Therapy):** Phase II trial enrolling 9 participants (5mg, 10mg cohorts completed; 15mg planned). Interim data expected in September 2025, focusing on Class I CF patients. Dosing at 280mg over 28 days highlights safety and tolerability. FDA meetings for pivotal trial design in H1 2026.
- **ARCT-810 (OTC Deficiency):** Phase II data shows glutamine normalization and urea cycle function improvement. FDA alignment on biomarkers (glutamine, 15N-ureagenesis) for Phase III design expected in H1 2026.
- **Vaccines:**
  - **CoStave (COVID):** UK MHRA approval in August, Japan PMDA in fall, US BLA in September 2025. Seasonal updates anticipated.
  - **ARCT-2138 (Flu):** Phase I shows immunogenicity across 4 strains at 2-20mcg doses, tolerable safety profile.
  - **ARCT-2304 (Bird Flu):** FDA Fast Track; Phase I (1.5-12mcg) shows safety, data pending later 2025.

**【CFO Financial Commentary】**
- **Revenue:** Q2 2025: $28M (YoY -44%), H1 2025: $58M (YoY -34%) due to CSL collaboration decline.
- **Expenses:**
  - R&D: Q2 2025: $29.6M (YoY -49%), H1 2025: $64.5M (YoY -42%) due to reduced manufacturing and clinical costs.
  - G&A: Q2 2025: $10.3M (YoY -16%), H1 2025: $21.7M (YoY -19%) from lower share-based comp.
- **Net Loss:** Q2 2025: $9.2M ($0.34/diluted share) vs. $17.2M ($0.64) in 2024.
- **Cash:** $253.4M as of June 30, 2025, extending runway to 2028.

**【Q&A Highlights】**
- **CF Trial Design:** No placebo arm; self-controlled with historical FEV data. FDA seeking safety, tolerability, and FEV improvement. Dose response expected but not required.
- **OTC Biomarkers:** Glutamine normalization and 15N-ureagenesis assay validated as endpoints. Higher 0.7mg/kg dose under consideration for Phase II.
- **Vaccine Updates:**
  - CoStave BLA for original vaccine; annual updates expected post-approval.
  - ARCT-2138 Phase I data vs. comparator expected later 2025.
  - ARCT-2304 Phase I results pending.
- **Regulatory Strategy:** Engaging FDA on pivotal trial designs for both therapeutics in H1 2026.


Arcturus Therapeutics Holdings Inc. (ARCT) Q2 2025 Earnings Conference Call Transcript

- **CF Pipeline Momentum**: ARCT-032 Phase 2 interim data mid-2025; 12-subject readout could enable Phase 3 with ~50-100 patients if FEV1 ≥3% improvement observed.
- **OTC Innovation**: 15N ureagenesis assay provides novel biomarker for assessing therapeutic impact in OTC deficiency.
- **Vaccine Strength**: KOSTAIVE EU approved, U.S. BLA filing Q3 2025; long-term safety data confirms favorable tolerability profile.
- **Financial Resilience**: Cash runway extended to 2028 with focused R&D spending; Q1 2025 net loss $14.1M, cash reserves $273.8M.

**【CEO Summary Section】**
- **ARCT-032 (Cystic Fibrosis)**: Phase 2 trial enrolling adults with CF ineligible for modulators; interim data for first two cohorts expected mid-2025. Focus on FEV1 improvement ≥3% and safety/tolerability.
- **ARCT-810 (OTC Deficiency)**: Phase 2 interim data Q2 2025; evaluating biomarkers like glutamine and 15N ureagenesis assay.
- **KOSTAIVE (COVID-19 Vaccine)**: EU approved; U.K. MAA filing Q2, U.S. BLA Q3 2025. Long-term safety data shows favorable tolerability, no myocarditis reports.
- **ARCT-2304 (Influenza A)**: FDA Fast Track designation; Phase 1 trial with 212 participants, interim data H2 2025.

**【CFO Financial Commentary】**
- **Q1 2025 Financials**: Revenue $29.4M (down 23% YoY), R&D expenses $34.9M (down 35% YoY), G&A $11.3M (down 24% YoY). Net loss $14.1M, cash runway extended to Q1 2028.
- **Milestones**: Received initial payment from CSL for EU KOSTAIVE approval; anticipate additional milestones post-U.S. commercialization (2028+).

**【Q&A Highlights】**
- **CF Program**: 12-subject Phase 2 interim data mid-2025; FEV1 improvement ≥3% could support Phase 3 with ~50-100 patients.
- **OTC Program**: Glutamine normalization and 15N assay data key for assessing urea cycle function.
- **Vaccine Commercialization**: KOSTAIVE U.S. BLA filing on track; no milestones tied to U.S. approval, only first sales (2028+).

Arcturus Therapeutics (ARCT)-12 May 25-2025 Q1 Earnings call transcript

- **KOSTAIVE Milestone**: First self-amplifying mRNA COVID vaccine approved in Europe, with U.S. filing anticipated in 2025.
- **CF Progress**: ARCT-032 Phase II interim data (Q2 2025) targeting 3% absolute FEV improvement to justify advancement.
- **Financial Strength**: $293.9M cash as of Q4 2024, with runway to Q1 2027 despite increased R&D spend.
- **Partnership Updates**: Meiji invests $20M in ARCALIS, advancing Japan manufacturing; CSL shares $28M Q4 gross profit.
- **Pipeline Expansion**: Phase I influenza vaccine (ARCT-2304) and Phase II OTC deficiency (ARCT-810) trials underway.


**【CEO Summary Section】**
- Received European Commission approval for KOSTAIVE, the first self-amplifying mRNA COVID-19 vaccine, with plans for U.S. and U.K. filings in 2025.
- Progress in Japan: Meiji submitted a 2-dose vial application for KOSTAIVE, targeting autumn 2025, and ARCALIS received approval for domestic manufacturing.
- Expanded STARR platform with Phase I influenza vaccine (ARCT-2304) and Phase II cystic fibrosis (ARCT-032) and ornithine transcarbamylase deficiency (ARCT-810) trials.
- Appointed Dr. Moncef Slaoui as Board Chair, leveraging his biotech expertise.

**【CFO Financial Commentary】**
- FY2024 revenue: $152.3M (down 9% YoY) due to lower CSL milestones, offset by BARDA flu program growth.
- Q4 2024 revenue: $22.8M (down 25% YoY) from reduced milestones.
- Operating expenses: $248M (flat YoY), driven by clinical trials for CF and OTC programs.
- Net loss: $80.9M (vs. $29.7M YoY), with cash runway extending to Q1 2027.
- CSL shared gross profit: $28M in Q4, with future payments tied to CSL's cost recoupment.

**【Q&A Highlights】**
- **Vaccine Milestones**: CSL will provide updates on flu combo vaccines; Q1 2025 call to detail KOSTAIVE milestones.
- **CF Program**: ARCT-032 interim data (Q2 2025) targeting 3% absolute FEV improvement; safety monitoring with DSMB oversight.
- **OTC Program**: Phase II data expected Q2 2025, focusing on biomarkers like ammonia and amino acids.
- **Financial Outlook**: Burn rate to increase in 2025-2026 due to CF/OTC trials, but strong cash position supports pipeline.
- **Japan Sales**: Meiji revised 2024 KOSTAIVE sales guidance to <2M doses; 2-dose vial approval expected Q2 2025.

**【Competitive Differentiation】**
- mRNA platform advantages: self-amplifying technology, LUNAR lipid delivery, and proprietary manufacturing.
- CFTR modulator comparison: 3% absolute FEV improvement threshold for Phase II success.
- Flu vaccine strategy: lower dose, extended durability, and seasonal strain alignment with WHO guidance.


Arcturus Therapeutics (ARCT)-6 Mar 25-2024 Q4 Earnings call transcript

Arcturus Therapeutics (ARCT)-7 Nov 24-2024 Q3 Earnings call transcript

Arcturus Therapeutics (ARCT)-5 Aug 24-2024 Q2 Earnings call transcript

Arcturus Therapeutics (ARCT)-8 May 24-2024 Q1 Earnings call transcript

- **Kostaive Milestone**: First self-amplifying mRNA vaccine approved globally, set to launch in Japan H2 2024 with government-backed demand for 2 annual boosters. 
- **Financial Stability**: $348.9M cash on hand with runway to Q1 2027; FY23 revenue $169.9M driven by CSL milestones. 
- **Pipeline Growth**: 7 infectious disease vaccines in development (including 2 wholly-owned) targeting $4B market; ARCT-810 and ARCT-032 interim data expected Q2 2024. 
- **Strategic Expansion**: New Lyme/gonorrhea programs leverage proven STARR platform; ARCALIS JV in Japan positions for global mRNA manufacturing leadership. 


**【CEO Summary Section】**
- **Kostaive Approval and Launch**: Received MHLW approval in Japan for self-amplifying mRNA COVID-19 vaccine, with launch expected in H2 2024. Japan government recommends 2 annual boosters for elderly, supporting long-term demand. 
- **Clinical Efficacy**: Kostaive demonstrated superior immune response vs. Comirnaty at 1/6th dose, with broader and more durable protection against Omicron variants. 
- **Pipeline Expansion**: Initiated Phase I for quadrivalent flu vaccine (ARCT-2138) and new programs for Lyme disease and gonorrhea, targeting $4B market opportunity. 
- **Therapeutic Progress**: ARCT-810 (OTC deficiency) Phase II interim data expected Q2 2024; ARCT-032 (CF) Phase Ib interim safety data also Q2. 

**【CFO Financial Commentary】**
- **Revenue**: FY23 total revenue $169.9M (down 17% YoY) due to termination of J&J/Vinbiocare collaborations, offset by $8.8M from BARDA flu agreement. 
- **Expenses**: FY23 operating expenses $245M (up 27% YoY) driven by R&D ($192.1M) for CSL programs and internal therapeutics. 
- **Financial Health**: Cash runway extended to Q1 2027; $348.9M cash as of Dec 31, 2023. No commercial revenue included in cash guidance. 
- **Partnership Milestones**: Received $396M in upfront payments and milestones from CSL since Nov 2022. 

**【Q&A Highlights】**
- **Japan Market Dynamics**: Government will cover Kostaive for elderly and high-risk groups, with potential 60M+ doses annually. Meiji Seika Pharma leading launch execution. 
- **Therapeutic Data Expectations**: ARCT-032 Phase Ib focuses on safety/tolerability; ARCT-810 Phase II evaluates biomarker changes (ammonia, orotic acid). 
- **Manufacturing Capacity**: ARCALIS JV in Japan expected to begin production H2 2024, with potential for global exports. 
- **Regulatory Updates**: European approval for Kostaive anticipated 2024, with U.S. filing to follow. 
- **Lyme/Gonorrhea Programs**: Preclinical data expected to inform IND submissions in 2025. 


Actual					-0.67	-0.55	-0.92	-1.25	-2.15	-2.07	-2.05	-1.47	-1.94	-0.82	-1.33	4.33	1.87	-1.98	-0.61	-0.32	-1	-0.64	-0.26	-1.11	-0.52	-0.34	-0.49	-1.03
Forecast					-0.59	-0.545	-0.4873	-0.8701	-1.2494	-2.2176	-1.4962	-1.6321	-1.4377	-1.8626	-1.8091	-1.72	0.0597	-0.2447	-1.6917	-0.9921	-1.2336	-1.4984	-1.2161	-0.5485	-1.1779	-0.8917	-0.899	-0.7769
Surprise	0.00%	0.00%	0.00%	0.00%	-13.56%	-0.92%	-88.80%	-43.66%	-72.08%	+6.66%	-37.01%	+9.93%	-34.94%	+55.98%	+26.48%	+351.74%	+3032.33%	-709.15%	+63.94%	+67.75%	+18.94%	+57.29%	+78.62%	-102.37%	+55.85%	+61.87%	+45.49%	-32.58%

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