8-K: Arcturus Therapeutics Announces Q4 and Fiscal Year 2024 Financial Results and Pipeline Progress

Arcturus Therapeutics reports Q4 and full-year 2024 financial results, highlighting progress in rare disease programs and mRNA vaccine development.

Summary

• Arcturus Therapeutics announced its financial results for the fourth quarter and fiscal year ended December 31, 2024.
• The company is progressing its rare disease programs and expects to share Phase 2 interim data for cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency programs in Q2 2025.
• Arcturus received European Commission approval for KOSTAIVE, its sa-mRNA COVID-19 vaccine.
• Meiji Seika Pharma and ARCALIS received MHLW approval for commercial manufacturing of KOSTAIVE in Japan.
• Meiji Seika Pharma submitted an application for a Two-Dose Vial of KOSTAIVE to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
• The company initiated a Phase 1 study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for pandemic influenza disease caused by the H5N1 virus.
• For the three months ended December 31, 2024, Arcturus reported revenue of $22.8 million, a decrease of $8.1 million from the same period in 2023.
• For the year ended December 31, 2024, the company reported revenue of $152.3 million, a decrease of $14.5 million from the year ended 2023.
• The net loss for the three months ended December 31, 2024, was approximately $30.0 million, or ($1.11) per diluted share.
• The net loss for the year ended December 31, 2024, was approximately $80.9 million, or ($3.00) per diluted share.
• Cash, cash equivalents, and restricted cash were $293.9 million as of December 31, 2024.
• The company's cash runway is expected to extend until the end of Q1 2027.

Sentiment

Score: 6

Explanation: The sentiment is neutral to slightly positive. While the company reported increased losses and decreased revenue, it also achieved key regulatory milestones and advanced its pipeline programs. The cash runway extending to Q1 2027 provides some stability.

Positives

• European Commission approval for KOSTAIVE provides access to 27 EU member states and 3 additional EEA countries.
• MHLW approval for Meiji Seika Pharma and ARCALIS to manufacture KOSTAIVE in Japan improves vaccine supply.
• Advancement of ARCT-032 and ARCT-810 into Phase 2 clinical trials demonstrates progress in rare disease programs.
• Initiation of Phase 1 study for ARCT-2304 (LUNAR-H5N1) expands the pipeline of mRNA vaccine candidates.
• CSL reported to Arcturus that Arcturus' share of gross profit from sales of KOSTAIVE was approximately $28.0 million during the quarter ended December 31, 2024.

Negatives

• Revenue decreased in both Q4 2024 and the full year 2024 compared to the previous year.
• Net loss increased significantly in both Q4 2024 and the full year 2024 compared to the previous year.
• Cash, cash equivalents, and restricted cash decreased from $348.9 million on December 31, 2023, to $293.9 million as of December 31, 2024.

Risks

• Forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially.
• The likelihood of success of the company's pipeline and partnered programs is uncertain.
• Clinical and preclinical data may not be predictive of future clinical results.
• The company's cash position and expected cash burn are subject to change.
• General business and economic conditions could impact the company's performance.

Future Outlook

Arcturus expects to share Phase 2 interim data for ARCT-032 and ARCT-810 in Q2 2025, provide interim Phase 1 data for ARCT-2304 in H2 2025, and anticipates a KOSTAIVE U.S. BLA filing in 2025; the company's cash runway is expected to extend until the end of Q1 2027.

Management Comments

• We continue to progress our flagship rare disease programs and look forward to sharing meaningful Phase 2 interim data from our cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency programs in Q2 2025, said Joseph Payne, President & CEO of Arcturus Therapeutics.
• Arcturus continues to make excellent progress with our STARR sa-mRNA vaccines pipeline and platform.
• We are very pleased to have recently received European Commission approval for KOSTAIVE and MHLW approval for Meiji Seika Pharma and ARCALIS to add commercial manufacturing sites in Japan.
• Our team continues to work diligently with CSL Seqirus to prepare KOSTAIVE regulatory filings for the United States and the United Kingdom.

Industry Context

Arcturus' progress with its mRNA platform and vaccine development aligns with the broader industry trend of leveraging mRNA technology for infectious diseases and rare diseases; the approval of KOSTAIVE in Europe positions Arcturus as a key player in the COVID-19 vaccine market.

Comparison to Industry Standards

• The development of KOSTAIVE, the world's first approved sa-mRNA COVID-19 vaccine, positions Arcturus ahead of some competitors in the mRNA vaccine space.
• Companies like Moderna and BioNTech have established mRNA vaccine platforms, but Arcturus' self-amplifying mRNA technology offers a unique approach.
• The Phase 2 clinical trials for ARCT-032 and ARCT-810 are comparable to similar trials conducted by other companies developing therapies for cystic fibrosis and OTC deficiency.
• The collaboration with CSL Seqirus for COVID-19 and flu programs is similar to partnerships between other biotech companies and larger pharmaceutical firms.

Management Changes

Stakeholder Impact

• Shareholders: The financial results and pipeline progress will impact shareholder value.
• Employees: The company's progress and financial stability will affect employee morale and job security.
• Patients: The development of new therapies for rare diseases and vaccines for infectious diseases will benefit patients.
• Partners: The collaborations with CSL Seqirus, Meiji Seika Pharma, and ARCALIS will impact the success of partnered programs.

Next Steps

• Provide interim data from the ARCT-032 Phase 2 CF study and the ARCT-810 Phase 2 OTC deficiency study in Q2 2025.
• Continue the Phase 1 study of ARCT-2304 (LUNAR-H5N1) and provide interim data in H2 2025.
• Prepare KOSTAIVE regulatory filings for the United States and the United Kingdom.
• Continue to work with CSL Seqirus on the COVID-19 and flu programs.
• Advance the development of ARCT-032 and ARCT-810.

Key Dates