• Revenue (FY 2024): $152.3 million, a decrease from $166.8 million in 2023.
• Revenue (Q4 2024): $22.8 million, down from $30.9 million in Q4 2023.
• Net Loss (FY 2024): Approximately $80.9 million or $3 per diluted share.
• Net Loss (Q4 2024): Approximately $30 million or $1.11 per diluted share.
• Total Operating Expenses (FY 2024): $248 million, compared to $245 million in 2023.
• Total Operating Expenses (Q4 2024): $56.2 million, compared to $49.1 million in Q4 2023.
• Research and Development Expenses (FY 2024): $195.2 million, up from $192.1 million in 2023.
• Research and Development Expenses (Q4 2024): $43.8 million, up from $36.6 million in Q4 2023.
• General and Administrative Expenses (FY 2024): $52.8 million, slightly down from $52.9 million in 2023.
• General and Administrative Expenses (Q4 2024): $12.4 million, compared to $12.5 million in Q4 2023.
• Cash and Cash Equivalents (End of 2024): $293.9 million, down from $348.9 million at the end of 2023.
• Cash Burn (FY 2024): Approximately $55 million, compared to $45 million in 2023.
• Gross Profit from KOSTAIVE Sales (Q4 2024): Approximately $28 million.

• Warning! GuruFocus has detected 4 Warning Signs with ARCT.

Release Date: March 06, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT) received European Commission approval for KOSTAIVE, the world's first approved self-amplifying mRNA COVID-19 vaccine.
• The company is progressing with its STARR self-amplifying mRNA platform pipeline in other infectious disease targets, including a Phase 1 study for a pandemic influenza vaccine candidate.
• Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT) has initiated a Phase 2 study for ARCT-032, a messenger RNA therapeutic candidate for cystic fibrosis, with interim data expected by the end of Q2 2025.
• The company has a strong financial position with cash and cash equivalents of $293.9 million as of December 31, 2024, and a cash runway expected to extend until the end of the first quarter of 2027.
• Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT) achieved a total of approximately $473.1 million in upfront payments and milestones from CSL as of December 31, 2024.

Negative Points

• Revenues for the year ended December 31, 2024, decreased by $14.5 million compared to the previous year, primarily due to lower milestone achievements from the CSL agreement.
• The company reported a net loss of approximately $80.9 million for the year ended December 31, 2024, compared to a net loss of $29.7 million for the previous year.
• Total operating expenses increased to $248 million for the year ended December 31, 2024, compared to $245 million for the previous year.
• Research and development expenses increased due to higher clinical trial costs associated with the OTC and CF programs, as well as the COVID-19 and LUNAR-FLU programs.
• The company anticipates an increase in cash burn over the next two years due to the progression of CF and OTC programs through their respective Phase 2 trials.

Q & A Highlights

Q: How should we think about the cadence of development milestones within the CSL collaboration, and are there updates on the flu vaccine program and a potential combo program with COVID flu? A: Joseph Payne, President and CEO, stated that CSL is providing guidance for the flu program, having completed Phase 1 for the quadrivalent version. CSL holds a global license for the flu program and will provide updates on further developments. Andrew Sassine, CFO, added that Arcturus will continue to receive milestones from CSL throughout the year, with more details to be provided in the first quarter call.

Q: How should we think about potential differentiation from competitors in the CF program, especially within the mRNA space? A: Joseph Payne explained that Arcturus differentiates itself through its proprietary mRNA molecule, LUNAR lipid nanoparticle delivery technology, and unique manufacturing and purification processes. These differences have been demonstrated in preclinical animal studies and early human clinical trials.

Q: Could you provide details on the CF interim data expected in Q2, including the size of the cohort and what you hope to show? A: Joseph Payne mentioned that the Phase 2 trial involves approximately 12 participants, with flexibility to increase that number. The interim update will include multiple patients and dose levels. An FEV lung function improvement of 3% would likely justify advancing ARCT-032 further into development, based on historical precedents in the CFTR modulator space.

Q: Can you comment on how enrollment for the CF program has been progressing and the anticipated split of Class I and CFTR intolerable patients? A: Joseph Payne stated that enrollment is on track, with multiple active sites. The CF community includes approximately 18% who do not respond to modulators, with about half being Class I null patients. The trial aims to address the unmet medical need across all genetic variations.

Q: What are the next steps towards commercialization of KOSTAIVE in the EU, and how will orders be managed? A: Andrew Sassine noted that CSL is leading the commercialization process in Europe, leveraging their experience in the flu program. The $28 million reported was Arcturus' share of gross profit from sales, contributing to recouping development costs. The cash runway is expected to extend until the end of Q1 2027, without relying on KOSTAIVE revenue.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.