Full Press Release Details
Initiated enrollment (Q1 2026) earlier than expected for 12‑week cystic fibrosis (CF) open label Phase 2 study; lung function (ppFEV1 and LCI) is being monitored in Class I CF subjects
Received regulatory direction on pediatric development strategy from FDA (Type C meeting) for ornithine transcarbamylase (OTC) deficiency program; End of Phase 2 (EOP2) meeting H2 2026
Investor conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE)--$ARCT#ClinicalTrial--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics, today announced its financial results for the quarter ended March 31, 2026, and provided corporate updates.
“Arcturus continues to advance its rare disease therapeutics portfolio. We have initiated enrollment of our 12‑week CF Phase 2 study in the first quarter of 2026, earlier than originally anticipated. We remain committed to advancing our inhaled mRNA therapy for people with CF Class I mutations,” said Joseph Payne, President & CEO of Arcturus. “Also, during the first quarter of 2026, we met with the FDA regarding the pediatric clinical development strategy for our OTC deficiency program and we now have a clear path toward initiating a pivotal trial which we will align further at the EOP2 meeting later this year. We welcomed two seasoned C-suite leaders, Alan H. Cohen, MD, Chief Medical Officer and Dennis M. Mulroy, Chief Financial Officer to strengthen the executive team.”
“We are pleased to announce a strong balance sheet and runway of over two and a half years, allowing our company to reach important clinical and regulatory milestones for its rare disease pipeline,” said Dennis M. Mulroy, Chief Financial Officer of Arcturus.
Recent Corporate Highlights
Financial Results for the three months ended March 31, 2026
Cash Position and Balance Sheet:
Cash, cash equivalents and restricted cash were $213.4 million as of March 31, 2026, and $232.8 million as of December 31, 2025. Through continued disciplined execution and focus on our existing rare disease clinical programs, we continue to have a cash runway extending beyond the second quarter of 2028.
Revenue in conjunction with strategic alliances and collaborations:
Arcturus’ current primary revenue stream relates to our grant agreement with BARDA. The year over year $27.3 million decrease in revenue was driven by lower revenue recognized under the CSL collaboration as we pivot from infectious disease vaccine development toward rare disease clinical programs.
Operating expenses:
Total operating expenses for the three months ended March 31, 2026, were $31.0 million compared to $46.2 million for the three months ended March 31, 2025.
Research and development expenses:
Research and development expenses were $21.5 million for the three months ended March 31, 2026, compared to $34.9 million in the comparable period last year. The decrease was primarily driven by lower manufacturing costs related to LUNAR-COVID and BARDA, as well as reduced clinical trial costs associated with the LUNAR-COVID program. Additional decreases were attributable to lower payroll and benefits costs associated with lower stock‑based compensation expense and a reduction in headcount. These reductions were partially offset by higher manufacturing costs related to LUNAR-OTC.
General and Administrative Expenses:
General and administrative expenses were $9.5 million for the three months ended March 31, 2026, compared to $11.3 million in the comparable period last year. The decrease was primarily due to reduced share-based compensation expense as well as reduced payroll and benefits costs associated with reductions in headcount.
Net Loss:
For the three months ended March 31, 2026, Arcturus reported a net loss of approximately $27.0 million, or ($0.95) per diluted share, compared to a net loss of $14.1 million, or ($0.52) per diluted share in the three months ended March 31, 2025.
Earnings Call: Thursday, May 7, 2026 @ 4:30 p.m. ET
About Arcturus
Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration with CSL Seqirus, U.S. BARDA for pandemic flu and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA (siRNA), circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 500 patents and patent applications in the U.S., Europe, Japan, China, and other countries). For more information, visitwww.ArcturusRx.com. Please connect with us onXandLinkedIn.
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, the likelihood of success of the Company’s pipeline (including ARCT-032 and ARCT-810) and partnered programs (including the COVID-19 and flu programs partnered with CSL Seqirus), the likelihood that the Company will continue to advance its rare disease therapeutics portfolio including its inhaled mRNA therapy, the likelihood that the Company will be able to advance ARCT-810 into a pivotal trial or pediatric clinical development, the planned EOP2 meeting and its timing, the size and scope of the open label Phase 2 study of ARCT-032, the outcomes of regulatory interactions and strategic planning for the ARCT-810 program, the likelihood that the Company will be able to collect exploratory data sufficient to progress to a pivotal pediatric study for ARCT-810, the likelihood that clinical data, including interim data, will be predictive of future clinical results, its current cash position and expected cash burn and runway, and the impact of general business and economic conditions. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the heading "Risk Factors" in Arcturus’ most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions to, the SEC, which are available on the SEC’s website atwww.sec.gov. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
| ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| March 31,2026 | December 31,2025 | |||||||
| (in thousands, except par value information) | (unaudited) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 211,375 | $ | 230,909 | ||||
| Accounts receivable | 1,343 | 5,564 | ||||||
| Prepaid expenses and other current assets | 4,164 | 4,973 | ||||||
| Total current assets | 216,882 | 241,446 | ||||||
| Property and equipment, net | 6,078 | 6,736 | ||||||
| Operating lease right-of-use assets, net | 20,423 | 21,081 | ||||||
| Non-current restricted cash | 2,028 | 1,885 | ||||||
| Total assets | $ | 245,411 | $ | 271,148 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,093 | $ | 4,235 | ||||
| Accrued liabilities | 22,666 | 23,898 | ||||||
| Deferred revenue | 7,610 | 8,246 | ||||||
| Total current liabilities | 34,369 | 36,379 | ||||||
| Operating lease liability, net of current portion | 19,680 | 20,784 | ||||||
| Total liabilities | 54,049 | 57,163 | ||||||
| Stockholders’ equity | ||||||||
| Common stock, $0.001 par value; 60,000 shares authorized; issued and outstanding shares were 28,423 at March 31, 2026 and 28,414 at December 31, 2025 | 28 | 28 | ||||||
| Additional paid-in capital | 732,888 | 728,547 | ||||||
| Accumulated deficit | (541,554 | ) | (514,590 | ) | ||||
| Total stockholders’ equity | 191,362 | 213,985 | ||||||
| Total liabilities and stockholders’ equity | $ | 245,411 | $ | 271,148 | ||||
| ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(unaudited) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| (in thousands, except per share data) | 2026 | 2025 | ||||||
| Revenue: | ||||||||
| Collaboration revenue | $ | 610 | $ | 25,477 | ||||
| Grant revenue | 1,451 | 3,905 | ||||||
| Total revenue | 2,061 | 29,382 | ||||||
| Operating expenses: | ||||||||
| Research and development, net | 21,527 | 34,893 | ||||||
| General and administrative | 9,465 | 11,315 | ||||||
| Total operating expenses | 30,992 | 46,208 | ||||||
| Loss from operations | (28,931 | ) | (16,826 | ) | ||||
| Finance income, net | 1,932 | 2,771 | ||||||
| Other income (expense) | 35 | (21 | ) | |||||
| Net loss | $ | (26,964 | ) | $ | (14,076 | ) | ||
| Net loss per share, basic and diluted | $ | (0.95 | ) | $ | (0.52 | ) | ||
| Weighted-average shares outstanding, basic and diluted | 28,421 | 27,107 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (26,964 | ) | $ | (14,076 | ) | ||
| Comprehensive loss | $ | (26,964 | ) | $ | (14,076 | ) |
Arcturus TherapeuticsPublic Relations & Investor RelationsNeda SafarzadehVP, Head of IR/PR/Marketing(858) 900-2682IR@ArcturusRx.com