Arcturus Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the three months ended September 30, 2026, was $18.3 million, compared to $17.2 million in the same period in 2025; for the nine months ended September 30, 2026, revenue was $23.3 million, down from $74.8 million in the prior year period.
• Collaboration revenue for the three months ended September 30, 2026, was $16.9 million versus $14.2 million in 2025; for the nine months, it was $18.3 million versus $64.1 million in 2025.
• Grant revenue for the three months ended September 30, 2026, was $1.4 million compared to $3.0 million in 2025; for the nine months, it was $5.0 million compared to $10.7 million in 2025.
• Research and development expenses were $17.0 million for the three months ended September 30, 2026, down from $23.3 million in 2025; for the nine months, expenses were $56.0 million, down from $87.7 million in 2025.
• General and administrative expenses were $10.5 million for the three months ended September 30, 2026, compared to $10.4 million in 2025; for the nine months, expenses were $30.9 million, down from $32.1 million in 2025.
• Net loss for the three months ended September 30, 2026, was $7.4 million ($0.26 per share), compared to a net loss of $13.4 million ($0.49 per share) in 2025; for the nine months, net loss was $58.2 million ($2.05 per share), compared to $36.7 million ($1.35 per share) in 2025.
• Cash and cash equivalents were $184.8 million as of September 30, 2026, a decrease of $46.1 million from $230.9 million on December 31, 2025.
• Deferred revenue decreased to $0.4 million as of September 30, 2026, from $8.2 million on December 31, 2025.
• Total liabilities were $46.6 million as of September 30, 2026, compared to $57.2 million on December 31, 2025.

Guidance and Future Outlook:

• ARCT-032 (CF) Phase 2 enrollment is expected to be completed by year-end 2026, with full data presentation planned for Q2 2027.
• ARCT-2601 (OTC Deficiency), the first candidate utilizing LUNAR 2.0™, plans to begin Phase 2 dosing in Q1 2027, with top-line data expected in H2 2027.
• The company plans to submit an Investigational New Drug (IND) application to the FDA for its PKU program in the second half of 2027.
• KOSTAIVE® commercial activities in the EU and UK are anticipated to begin in 2027 following the transfer of Marketing Authorization Holders in September and October 2026.
• Management expects to maintain a cash runway of over two years through year-end 2028.

Business Segments and Product Lines:

• ARCT-810 Phase 2 interim data demonstrated meaningful biomarker activity, reducing and/or maintaining first-morning fasting ammonia within the normal range and reducing glutamine levels in all participants at doses of 0.3 mg/kg and 0.5 mg/kg.
• LUNAR 2.0™, the next-generation mRNA delivery platform, demonstrated a 38-fold improvement in potency over the key lipid in ARCT-810 in non-human primate studies based on human ornithine transcarbamylase expression.
• ARCT-2601 is the first mRNA therapeutic candidate utilizing LUNAR 2.0™ technology, with non-human primate data suggesting potential for lower and/or less frequent dosing compared to ARCT-810.
• The pipeline has expanded to include programs targeting phenylketonuria (PKU) and gout, supported by the LUNAR 2.0™ platform.
• ARCT-032 is actively and financially supported by Thermo Fisher Scientific, with significant contributions expected upon a decision to proceed into Phase 3.
• Meiji Seika Pharma continues to distribute KOSTAIVE® in Japan for the 2026/2027 season.
• The company successfully completed the myNEO acquisition, integrating AI-driven capabilities in antigen design, mRNA optimization, and target identification.

Market and Competitive Landscape:

• KOSTAIVE® is the first self-amplifying mRNA (sa-mRNA) COVID vaccine in the world to be approved.
• The company published Phase 1 study results for a sa-mRNA pandemic influenza vaccine in Nature Communications, indicating immunological benefits versus standard of care and a favorable safety profile.
• Enrollment for ARCT-032 has accelerated due to increased site activations in Israel and Turkey.

Risks and Challenges:

• The press release includes standard forward-looking statements regarding the likelihood of success of the pipeline, timing of clinical milestones, and regulatory approvals, noting these are subject to risks and uncertainties.
• Actual results may differ from projections due to known and unknown risks, including general business and economic conditions.

Management Commentary and Tone:

• Joseph Payne, President & CEO, described the third quarter as a "pivotal step forward" for the liver therapeutics franchise, citing encouraging ARCT-810 results and the introduction of LUNAR 2.0™.
• Dennis Mulroy, Chief Financial Officer, emphasized a "disciplined investment" approach and stated the company continues to maintain a strong balance sheet.

Other Key Points:

• The company received a $12.0 million payment from CSL Seqirus under a termination and settlement agreement, which offset cash used for clinical development activities.
• Marketing Authorization Holders for KOSTAIVE® in the EU and UK were transferred from CSL Seqirus to Arcturus in September and October 2026, respectively.
• The amended Phase 2 protocol for ARCT-2601 is expected to incorporate the candidate into the ongoing ARCT-810 Phase 2 study to evaluate participants with OTCD ages 12 years and older.
• The company holds over 500 patents and patent applications in the U.S., Europe, Japan, China, and other countries.