Arcturus Therapeutics(ARCT) - 2025 Q2 - Quarterly Results

Corporate and Pipeline Highlights Arcturus is advancing its mRNA pipeline, with key progress in its Cystic Fibrosis (ARCT-032) and OTC Deficiency (ARCT-810) programs, announcing positive interim data for ARCT-810 and expecting Phase 2 data for ARCT-032 in September 2025, while progressing regulatory filings for KOSTAIVE® globally and reporting positive Phase 1 results for its seasonal flu vaccine (ARCT-2138) with Phase 1 results for its pandemic flu vaccine (ARCT-2304) expected in 2025 Cystic Fibrosis (CF) Program (ARCT-032) The Phase 2 trial for ARCT-032 is advancing, with enrollment expected to be complete by year-end 2025, interim data from the first nine participants will be presented in September 2025, and the company plans to meet with regulatory agencies in H1 2026 to discuss pivotal trial plans * Phase 2 interim data from the first nine participants (N=3 @ 5 mg; N=6 @ 10 mg) is scheduled to be presented in September 2025[1][3] * The Phase 2 trial is expected to complete enrollment by the end of 2025[1][3] * Meetings with the FDA and other regulatory agencies to discuss Phase 3 plans are anticipated in the first half of 2026, with Phase 3 initiation planned for 2026[3] OTC Deficiency Program (ARCT-810) Positive interim data from two Phase 2 studies showed that ARCT-810 led to decreases in glutamine levels to within the normal range and maintained stable ammonia levels in participants, with the treatment generally safe and well-tolerated across 40 participants to date, and the company expects to align with regulatory agencies on the Phase 3 trial design in the first half of 2026 * Positive interim Phase 2 data showed decreases in glutamine to normal range and stable ammonia levels in participants on standard of care therapy[3] * Data from a newly developed assay suggested improvement of urea cycle function in all three participants in the Phase 2 U.S. study[3] * The company plans to align with regulators on the Phase 3 trial design and pediatric studies in H1 2026[1][5] KOSTAIVE® (COVID-19 Vaccine) Regulatory Updates Regulatory submissions for KOSTAIVE® are progressing in the UK, Japan, and the U.S., with approval in the UK expected by September 2025, Japanese approvals anticipated in Q3/Q4 2025, and a U.S. BLA filing on track for Q3 2025 * UK (MHRA) approval is expected by September 2025[5] * Japan (PMDA) approvals for the lyophilized vaccine and the 2025-2026 variant update are anticipated in Q3/Q4 2025[5] * U.S. (FDA) BLA filing remains on track for Q3 2025, with an approval decision expected in 2026[5] Influenza Vaccine Programs (ARCT-2138 & ARCT-2304) The seasonal flu vaccine (ARCT-2138) showed positive Phase 1 results, demonstrating immunogenicity against all four strains in both young and older adults with a good safety profile, while the pandemic flu vaccine (ARCT-2304), supported by BARDA, has received FDA Fast Track Designation, and Phase 1 immunogenicity results are expected in Q4 2025 * Seasonal flu vaccine (ARCT-2138) Phase 1 study showed immunogenicity against all four influenza strains at doses as low as 2 μg and was well-tolerated[5] * Pandemic flu vaccine (ARCT-2304) received U.S. FDA Fast Track Designation[5] * Phase 1 immunogenicity results for the pandemic flu vaccine (ARCT-2304) are expected in Q4 2025, with no safety concerns raised from available data[5] Financial Results (Q2 2025) For Q2 2025, Arcturus reported revenues of $28.3 million and a net loss of $9.2 million, or ($0.34) per share, representing a decrease in revenue but a smaller net loss compared to Q2 2024, primarily due to reduced R&D spending as key programs mature, with the company's cash position remaining strong at $253.4 million and a projected cash runway into 2028 Statement of Operations Analysis Revenue for Q2 2025 was $28.3 million, a decrease from $49.9 million in Q2 2024, primarily due to lower revenue from the CSL collaboration as KOSTAIVE® progresses towards commercialization, while operating expenses also decreased significantly to $39.9 million from $71.0 million year-over-year, driven by lower R&D costs, resulting in a reduced net loss of $9.2 million compared to $17.2 million in the prior year's quarter Statement of Operations (in thousands) | Metric (in thousands) | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $28,301 | $49,859 | $57,683 | $87,871 | | R&D Expenses | $29,579 | $58,669 | $64,471 | $112,242 | | G&A Expenses | $10,338 | $12,316 | $21,654 | $27,167 | | Net Loss | $(9,180) | $(17,216) | $(23,256) | $(44,033) | | Net Loss per Share | $(0.34) | $(0.64) | $(0.86) | $(1.64) | * The decrease in revenue was primarily driven by reduced activity and lower amortization from the CSL collaboration as KOSTAIVE® nears commercialization[6] * The decrease in R&D expenses was mainly due to lower manufacturing and clinical costs for the KOSTAIVE and LUNAR-FLU programs, partially offset by higher clinical costs for the cystic fibrosis Phase 2 trials[8][9] Balance Sheet and Cash Position As of June 30, 2025, Arcturus had $253.4 million in cash, cash equivalents, and restricted cash, down from $293.9 million at year-end 2024, with total assets at $309.3 million and total liabilities at $78.2 million, and the company projects its current cash runway extends into 2028 Balance Sheet (in thousands) | Metric (in thousands) | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents & restricted cash | $253,352 | $293,913 | | Total Assets | $309,270 | $344,069 | | Total Liabilities | $78,217 | $103,091 | | Total Stockholders' Equity | $231,053 | $240,978 | * The company's cash runway is expected to extend into 2028 based on the current pipeline and programs[12] Company Overview and Forward-Looking Statements Arcturus Therapeutics, founded in 2013 and based in San Diego, is a commercial mRNA medicines company with proprietary LUNAR® delivery and STARR® mRNA technologies, having developed KOSTAIVE®, the first approved sa-mRNA COVID vaccine, and maintaining a pipeline focused on rare diseases like OTC deficiency and cystic fibrosis, as well as infectious disease vaccines, while the press release contains forward-looking statements regarding clinical trial timelines, regulatory approvals, and financial projections, which are subject to substantial risks and uncertainties * Arcturus is a commercial mRNA company with key technologies including LUNAR® lipid-mediated delivery and STARR® self-amplifying mRNA[13] * The company's pipeline includes RNA therapeutic candidates for OTC deficiency and cystic fibrosis, along with partnered mRNA vaccine programs for COVID-19 and influenza[13] * The report includes forward-looking statements concerning clinical trial timelines, regulatory approvals, and financial performance, which are subject to significant risks as detailed in SEC filings[14]