Latest news with #ARCT-810
Business Wire
11-08-2025
- Business
- Business Wire
Arcturus Therapeutics Announces Second Quarter 2025 Financial Update and Pipeline Progress
SAN DIEGO--(BUSINESS WIRE)--Arcturus Therapeutics Holdings Inc. (the 'Company', 'Arcturus', Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics and infectious disease vaccines, today announced its financial results for the second quarter ended June 30, 2025, and provided corporate updates. 'The Company continues to advance and provide meaningful clinical data across our mRNA therapeutics and vaccines pipeline,' said Joseph Payne, President & CEO of Arcturus Therapeutics. 'We are especially pleased with the recent proof-of-concept in our liver platform based on the positive ARCT-810 interim Phase 2 data and look forward to sharing two cohorts of Phase 2 CF data in September.' Recent Corporate Highlights Arcturus is advancing enrollment of adult CF participants in the open label Phase 2 multiple ascending dose CF study (NCT06747858) with daily inhaled treatments of ARCT-032 over a period of 28 days and expects to complete enrollment as planned by year end. All six participants in the second cohort (10 mg) are expected to complete dosing in early September. The Company expects to provide Phase 2 interim data from the first nine enrolled participants (N = 3 @ 5 mg; N = 6 @ 10 mg) in September 2025. The Company anticipates meetings with the FDA and other regulatory agencies in H1 2026 to discuss the Phase 2 data and plans for pivotal trials, including the enrollment of adolescent and pediatric participants, followed by Phase 3 initiation in 2026. In June, the company announced positive interim data from two Phase 2 multiple dose studies conducted in the OTC program. In each study and in combined analyses of both Phase 2 studies, decreases in glutamine levels to within normal range were observed following multiple ARCT-810 administrations to participants who remained on their standard of care therapy. Mean ammonia levels were stable within the normal range following at least two doses of ARCT-810 and remained stable for approximately 28 days after completion of dosing. During the treatment phase and follow-up, two out of three participants in the Phase 2 U.S. study (NCT06488313) showed increases in relative ureagenesis function to levels observed in asymptomatic OTC deficient patients (≥ 50% of healthy controls) as measured by a newly developed and optimized 15N-ureagenesis assay. The remaining participant demonstrated increased 15N-citrulline enrichment. The data, taken together, suggest improvement of urea cycle function in all 3 participants. ARCT-810 was generally safe and well tolerated in single dose Phase 1/1b and multi-dose Phase 2 studies, comprising 40 participants to date, including 20 OTC deficient participants. The Company is preparing for meetings with the U.S. FDA and other regulatory agencies to discuss the clinical significance of the observed biomarker changes in relation to the design of the Phase 3 pivotal trial and pediatric studies. Phase 3 biomarker and trial design alignment with regulators is expected in first half of 2026. KOSTAIVE® regulatory updates include: A Marketing Authorization Application (MAA) filed by CSL to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in Q2 2025, approval expected by September 2025. NDA applications filed by Meiji Seika Pharma to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for the 2-dose lyophilized vaccine presentation in H1 2025, and the 2025-2026 season's SARS-CoV-2 variant update was completed in Q2 2025, with anticipated approvals in Q3/Q4 2025. U.S. BLA filing to the FDA remains on track for Q3 2025, with an approval decision expected in 2026. Under our collaboration with CSL Seqirus, we conducted a Phase 1 study (NCT06125691) of ARCT-2138, an sa-mRNA seasonal influenza vaccine candidate, encoding hemagglutinin (HA) and neuraminidase (NA) of 4 influenza strains recommended by the WHO. The clinical study report was finalized in June 2025. The study objectives were to evaluate the safety and tolerability and to describe the immune response of different dose levels of the vaccine in 100 young adults (18-49 years of age) and 35 older adults (≥ 65 years of age). All tested dose levels of ARCT-2138 were immunogenic against all four influenza strains as measured by hemagglutinin-inhibition assay in both age groups, demonstrating a modest dose-response (≤ 2.1-fold) within the range of the tested doses (2-20 μg). ARCT-2138 also induced NA-specific antibody responses at all tested dose levels of ARCT-2138 against all four influenza strains. The frequencies of unsolicited adverse events and medically attended adverse events were similar to comparator vaccines. No major safety concerns were raised from the study results. Overall, the study showed the potential of a self-amplifying mRNA vaccine, encoding eight antigens, to induce an immune response in both young and older adults with a dose as low as 2 μg, and tolerable up to 20 μg. The Company is expecting Phase 1 results in 2025 from ARCT-2304, an sa-mRNA vaccine candidate for Pandemic Influenza A Virus H5N1 which recently received U.S. FDA Fast Track Designation. No safety concerns were raised from available clinical data from the ongoing Phase 1 clinical study (NCT06602531) with 212 participants; all three tested dose levels (1.5, 5, and 12 µg) were well-tolerated, with the majority of the reported solicited AEs being mild-to-moderate severity and short-lived. Immunogenicity results are expected in Q4 2025. This project has been supported in whole with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50122C0007. The Company appointed Moncef Slaoui, Ph.D., as Chairman of the Board on July 1, 2025. Financial Results for the three months ended June 30, 2025 Revenues in conjunction with strategic alliances and collaborations: Arcturus' primary revenue streams include license fees, consulting and related technology transfer fees, reservation fees and collaborative payments received from research and development arrangements with pharmaceutical and biotechnology partners. Revenue for the three and six months ended June 30, 2025, was $28.3 million and $57.7 million, respectively, representing decreases of $21.6 million and $30.2 million compared to the same periods in 2024. These declines were primarily driven by reduced revenue from the CSL collaboration, reflecting lower supply agreement activity and lower amortization of the upfront payment as KOSTAIVE® progresses toward commercialization. Operating expenses: Total operating expenses for the three months ended June 30, 2025, were $39.9 million compared with $71.0 million for the three months ended June 30, 2024. Total operating expenses for the six months ended June 30, 2025, were $86.1 million compared with $139.4 million for the six months ended June 30, 2024. Research and development expenses: Research and development expenses consist primarily of external manufacturing costs, in vivo research studies and clinical trials performed by contract research organizations, clinical and regulatory consultants, personnel-related expenses, facility-related expenses and laboratory supplies related to conducting research and development activities. Research and development expenses were $29.6 million for the three months ended June 30, 2025, compared with $58.7 million for the three months ended June 30, 2024. The decrease was primarily driven by lower manufacturing costs for the KOSTAIVE, LUNAR-FLU, and cystic fibrosis programs, and reduced clinical trial expenses for KOSTAIVE and Ornithine Transcarbamylase Deficiency. Lower payroll and employee benefits also contributed to the decrease. These decreases were partially offset by higher clinical costs for cystic fibrosis following the start of Phase 2 trials in fiscal year 2025. Research and development expenses were $64.5 million for the six months ended June 30, 2025, compared with $112.2 million for the three months ended June 30, 2024. The decrease was primarily driven by lower manufacturing and clinical costs for the KOSTAIVE program, reflecting the program's transition from a development program to the commercial phase. Additional decreases resulted from lower payroll and benefits expenses and reduced facilities and equipment costs following the downsizing of operations. These reductions were partially offset by higher clinical expenses for the cystic fibrosis program. General and Administrative Expenses: General and administrative expenses primarily consist of salaries and related benefits for executive, administrative, legal and accounting functions and professional service fees for legal and accounting services as well as other general and administrative expenses. General and administrative expenses were $10.3 million and $21.7 million for the three and six months ended June 30, 2025, respectively, compared with $12.3 million and $27.2 million in the comparable periods last year. The decreases in both periods were primarily due to reduced share-based compensation expense as well as reduced payroll and benefits. We expect general and administrative expenses to continue to decrease slightly during the next twelve months driven by lower share-based compensation costs. Net Loss: For the three months ended June 30, 2025, Arcturus reported a net loss of approximately $9.2 million, or ($0.34) per diluted share, compared with a net loss of $17.2 million, or ($0.64) per diluted share in the three months ended June 30, 2024. For the six months ended June 30, 2025, Arcturus reported a net loss of approximately $23.3 million, or ($0.86) per diluted share, compared with a net loss of $44.0 million, or ($1.64) per diluted share in the six months ended June 30, 2024. Cash Position and Balance Sheet: Cash, cash equivalents and restricted cash were $253.4 million as of June 30, 2025, and $293.9 million on December 31, 2024. Based on the current pipeline and programs, the cash runway remains extended into 2028. Earnings Call: Monday, August 11, 2025 @ 4:30 p.m. ET Domestic: 1-800-274-8461 International: 1-203-518-9814 Conference ID: ARCTURUS Webcast: Link About Arcturus Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company 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 for innovative mRNA vaccines with CSL Seqirus, 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 OTC deficiency and cystic fibrosis (CF), 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, 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, visit In addition, please connect with us on X (formerly Twitter) and LinkedIn. 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 of and timing for providing interim data from the ARCT-032 Phase 2 CF study, the likelihood of and timing for completion of enrollment in the ARCT-032 Phase 2 CF study, the likelihood of and timing for Phase 3 trial design alignment with regulatory agencies for ARCT-810, the timing for Phase 1 results from the BARDA pandemic flu Phase 1 study, the likelihood of and timing for meetings with the FDA and other regulatory agencies relating to the CF and OTC programs, the likelihood of and timing for initiation of Phase 3 studies for the CF and OTC programs, the timing for completion of enrollment in the ARCT-032 (CF) Phase 2 study, the likelihood of and timing for approval of the MAA on KOSTAIVE filed by CSL to the UK MHRA, the likelihood and timing for approvals of NDA applications for KOSTAIVE filed by Meiji Seika Pharma with Japan's PMDA, the planned U.S. BLA filing and expected approval decision for KOSTAIVE, efforts for optimization and testing for seasonal influenza program, the timing for Phase 1 results for the pandemic influenza vaccine candidate, the likelihood that general and administrative expenses will decrease, the likelihood that preclinical or clinical 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 at 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 SUBSIDIARIES (unaudited) June 30, June 30, (in thousands, except per share data) 2025 2024 2025 2024 Revenue: Collaboration revenue $ 24,510 $ 45,976 $ 49,987 $ 78,574 Grant revenue 3,791 3,883 7,696 9,297 Total revenue 28,301 49,859 57,683 87,871 Operating expenses: Research and development, net 29,579 58,669 64,471 112,242 General and administrative 10,338 12,316 21,654 27,167 Total operating expenses 39,917 70,985 86,125 139,409 Loss from operations (11,616 ) (21,126 ) (28,442 ) (51,538 ) Loss from foreign currency (127 ) (388 ) (149 ) (441 ) Finance income, net 2,567 4,148 5,339 8,164 Net loss before income taxes (9,176 ) (17,366 ) (23,252 ) (43,815 ) Provision (benefit) for income taxes 4 (150 ) 4 218 Net loss $ (9,180 ) $ (17,216 ) $ (23,256 ) $ (44,033 ) Net loss per share, basic and diluted $ (0.34 ) $ (0.64 ) $ (0.86 ) $ (1.64 ) Weighted-average shares outstanding, basic and diluted 27,129 26,967 27,118 26,923 Comprehensive loss: Net loss $ (9,180 ) $ (17,216 ) $ (23,256 ) $ (44,033 ) Comprehensive loss $ (9,180 ) $ (17,216 ) $ (23,256 ) $ (44,033 ) Expand
Business Wire
30-06-2025
- Business
- Business Wire
Arcturus Therapeutics Announces Positive Interim Phase 2 Multiple Dose Data for Ornithine Transcarbamylase (OTC) Deficiency Program
SAN DIEGO--(BUSINESS WIRE)--Arcturus Therapeutics Holdings Inc. (the 'Company', 'Arcturus', Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announces positive Phase 2 interim results in people with OTC deficiency treated with ARCT-810, an mRNA therapeutic candidate designed to replace the OTC enzyme and restore urea cycle activity preventing hyperammonemia crises. 'We are very pleased with these new ARCT-810 clinical results, where we have achieved strong biological effects in both Phase 2 studies, including significant and consistent reduction and normalization of abnormally elevated glutamine, an important biomarker to monitor urea cycle function,' said Dr. Juergen Froehlich, Chief Medical Officer of Arcturus. 'Furthermore, in our ongoing U.S. Phase 2 study, we are excited to report the first significant relative ureagenesis function (RUF) improvements using a new and optimized 15 N-ureagenesis assay. Along with the observation of stable ammonia levels in all patients during treatment, these data add a level of robustness to this new interim dataset. I am also very pleased to see that our LUNAR® delivery technology continues to be generally safe and well tolerated. The combined biomarker data is unprecedented for an mRNA rare disease therapeutic and, importantly, provides a potentially accelerated path forward to a multi-biomarker driven pivotal study.' 'It is extremely rewarding to see the first mRNA therapeutic produce such solid clinical results in an area of important unmet medical need,' said Dr. Marshall Summar, CEO of Uncommon Cures. 'This is a very positive step for the OTC deficient community as there are currently limited options for symptomatic patients suffering from this devastating disease.' Multiple dosing data are available from two Phase 2 studies; a completed placebo-controlled study in Europe that randomized six participants to ARCT-810 doses and an open-label multiple ascending dose study with interim data from the initial three completed participants. The ongoing U.S. Phase 2 open-label study uses a modified and improved 15 N-ureagenesis assay (Allegri et al., 2025). The assay measures relative ureagenesis function (RUF) against a normal range established from healthy controls (N = 29). The assay is not impacted by ammonia scavengers, has low intraindividual variability, and can distinguish between symptomatic and asymptomatic OTC deficient patients. Linear Mixed-Effects Model (LMM) was applied as an exploratory analysis to the Phase 2 glutamine and ureagenesis data. LMM is suitable for small-N analyses, i.e. rare disease trial datasets. ARCT-810 treatment significantly reduces glutamine levels In the combined analysis of both Phase 2 studies, significantly (p-value = 0.0055; LMM) decreased glutamine levels were observed following multiple ARCT-810 administrations to patients who remained on their standard of care therapy. These results provide statistical evidence that glutamine levels decrease over time in both Phase 2 studies, suggesting a robust effect across the patient cohorts. In the Phase 2 randomized European study, glutamine levels in patients who received multiple doses of ARCT-810 significantly (p-value = 0.016; LMM) decreased during the dosing period. In the Phase 2 open-label U.S. study, all three participants had a sustained and significant (p-value = 0.004; LMM) decrease in glutamine from baseline reaching normal levels after the first three doses. These results provide strong evidence that glutamine levels decreased in both Phase 2 studies, with a steeper decline in the U.S. Phase 2 study, likely attributed to the two participants with more severe disease. After treatment completion, glutamine levels returned to baseline over a period of several weeks. ARCT-810 treatment significantly increases 15 N-ureagenesis In the first three participants in the ongoing Phase 2 open-label study, RUF statistically (p-value = 0.026, LMM) increased at all post treatment evaluations from a baseline of 29.0% (SD; 9.1%) to 43.7% (SD; 21.7%) at 28 days post-fifth dose. These results suggest a progressive increase of functional OTC enzyme in the liver with continued administrations. Two of the three participants achieved RUF > 50% indicating a clinically meaningful improvement in urea cycle flux. These encouraging 15 N-Ureagenesis data provide additional support and confidence in the favorable glutamine results. Ammonia remained stable and within normal range Further supporting the favorable glutamine and ureagenesis data, patients receiving ARCT-810, in both Phase 2 studies, maintained ammonia levels within the normal range following at least two doses and remained stable for approximately 28 days after completion of dosing. Two participants in the European Phase 2 randomized study (one receiving placebo, one receiving ARCT-810) reported a hyperammonemia event (ammonia ≥ 100 μmol/L). One participant had normal ammonia levels that remained stable during ARCT-810 treatment; four weeks after the last dose, this participant received an oral corticosteroid to treat an asymptomatic transaminase elevation (a laboratory SAE that did not meet Hy's law criteria). Subsequently, transaminase levels returned to normal range, and the temporary increase of ammonia was considered related to corticosteroid treatment. ARCT-810 continues to be safe and well tolerated ARCT-810 was generally safe and well tolerated in single dose Phase 1/1b and multi-dose Phase 2 studies, comprising 40 participants to date, including 20 OTC deficient participants. The early studies enabled the Company to improve the tolerability of the infusion regimen without using corticosteroid pre-treatment. To date, no serious IRRs have been observed using the improved 3-hour IV regimen (N = 8; up to 6 infusions) in the Phase 2 protocols. Virtual KOL Event: Monday, June 30, 2025 @12:00 p.m. ET About Ornithine Transcarbamylase Deficiency Ornithine transcarbamylase (OTC) deficiency is the most common urea cycle disorder. Urea cycle disorders are a group of inherited metabolic disorders of the liver that make it difficult for affected patients to remove toxic waste products as proteins are digested. OTC deficiency caused by mutations in the X-linked OTC gene, leads to a non-functional or deficient OTC enzyme and usually affects males more severely. OTC is a critical liver enzyme which catalyzes a metabolic process that converts toxic ammonia to urea that is excreted by the kidney. This conversion does not occur properly in patients with OTC deficiency and, aside from the risk of high ammonia levels, leads to increased blood concentrations of glutamine with low to normal levels of citrulline and increases in urine orotic acid. High blood ammonia levels in OTC deficiency may cause health crises with seizures, progressive neurocognitive impairment, coma, and death. Severe cases of OTC deficiency usually present early in life, but patients with less severe symptoms may be diagnosed as adolescents and adults. There is currently no cure for OTC deficiency, apart from liver transplant. However, liver transplantation comes with significant risks of surgical and postsurgical complications such as organ rejection, and recipients must take immunosuppressant drugs for the rest of their lives. The current standard of care for OTC deficiency patients is a well-controlled, but challenging to maintain, low-protein diet, substitution of essential amino acids and treatment with nitrogen scavenging medications that keeps the ammonia from rising to acutely toxic levels but may not prevent chronic neurotoxic effects. These treatments do not address the underlying cause of disease. In Europe and the U.S., approximately 10,000 people have OTC deficiency. About ARCT-810 ARCT-810 is an intravenously administered investigational mRNA therapeutic designed to express normal functional OTC enzyme in the liver of individuals with OTC deficiency. ARCT-810 has received Orphan Medicinal Product Designation and an approved pediatric investigation plan (PIP) from the European Medicines Agency (EMA), and Orphan Drug Designation, Fast Track Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) for the treatment of OTC deficiency. OTC is a key enzyme in the urea cycle which converts toxic ammonia into urea. Elevated ammonia can lead to metabolic crises with progressive and irreversible neurocognitive damage. A safe and effective mRNA therapeutic may restore normal functional OTC enzyme in the liver which could improve urea cycle activity, reduce abnormally elevated glutamine, maintain normal ammonia levels and potentially eliminate the risk of future metabolic crises. ARCT-810 is based on Arcturus' mRNA design construct and proprietary manufacturing process. ARCT-810 also utilizes Arcturus' extensive and propriety lipid library and employs the Company's LUNAR® delivery platform to deliver OTC mRNA to hepatocytes. About Glutamine as a Biomarker Glutamine is used as an important biomarker by clinicians to monitor urea cycle function in OTC deficient patients. Glutamine reflects the body's nitrogen buffering capacity. In urea cycle disorders, excess nitrogen is initially incorporated into glutamine, allowing glutamine to rise steadily as a compensatory mechanism before ammonia levels begin to spike. This role makes glutamine a more stable and predictive biomarker in patients who are not experiencing hyperammonemia. Glutamine assessments have significantly lower intra-subject variability than ammonia (15% vs. 56%), making it more reliable for monitoring metabolic control in stable conditions (Lichter-Konecki et al., 2016). About Arcturus Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company 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 for innovative mRNA vaccines with CSL Seqirus, 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 OTC deficiency and cystic fibrosis (CF), 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, 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, visit In addition, please connect with us on X (formally Twitter) and LinkedIn. 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-810), the likelihood that clinical results will be predictive of future clinical results or of potential therapeutic benefit, likelihood of continuation of the OTC program, likelihood of further enrollment in the ongoing ARCT-810 Phase 2 study, the likelihood of a path toward and initiation of a multi-biomarker driven pivotal study, the likelihood that continued ARCT-810 administrations will result in a progressive increase of functional OTC enzyme, the likelihood of any regulatory agency recognizing any biomarker in determinations of regulatory approval including glutamine levels or 15N assay results, 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 Securities and Exchange Commission (the 'SEC'), which are available on the SEC's website at 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.
