Price Target Changed • May 20
Price target decreased by 15% to US$19.89 Down from US$23.30, the current price target is an average from 9 analysts. New target price is 192% above last closing price of US$6.82. Stock is down 44% over the past year. The company is forecast to post a net loss per share of US$3.80 next year compared to a net loss per share of US$2.40 last year. Announcement • Apr 28
Arcturus Therapeutics Holdings Inc. to Report Q1, 2026 Results on May 07, 2026 Arcturus Therapeutics Holdings Inc. announced that they will report Q1, 2026 results After-Market on May 07, 2026 Announcement • Apr 27
Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 05, 2026 Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 05, 2026. Announcement • Feb 18
Arcturus Therapeutics Holdings Inc. to Report Q4, 2025 Results on Mar 03, 2026 Arcturus Therapeutics Holdings Inc. announced that they will report Q4, 2025 results at 4:00 PM, Eastern Standard Time on Mar 03, 2026 Announcement • Nov 13
Arcturus Therapeutics Holdings Inc. announced delayed 10-Q filing On 11/12/2025, Arcturus Therapeutics Holdings Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Oct 29
Arcturus Therapeutics Holdings Inc. to Report Q3, 2025 Results on Nov 10, 2025 Arcturus Therapeutics Holdings Inc. announced that they will report Q3, 2025 results After-Market on Nov 10, 2025 Announcement • Oct 22
Arcturus Therapeutics Provides Interim Phase 2 Data for Cystic Fibrosis (CF) Program Arcturus Therapeutics Holdings Inc. announced interim results from its ongoing Phase 2 clinical trial of ARCT-032, an investigational inhaled mRNA therapy for people with cystic fibrosis. In the second cohort of the study, six Class I CF adults received inhaled 10 mg doses of ARCT-032 daily over 28 days. Full FEV1 data tables are available on Arcturus' website. A larger, longer-duration study is planned to substantiate the clinical relevance of these findings. The HRCT mucus reduction and supporting lung function data from the second cohort (10 mg), combined with additional data collected from the ongoing third cohort (15 mg) will guide dose selection, treatment duration, and endpoint strategy for future studies, including the conduct of a 12-week safety and preliminary efficacy clinical trial that is planned to begin in the first half of 2026. Cystic fibrosis is a life-shortening disease with a worldwide distribution. Currently approved CFTR modulator therapies are designed to increase function of the CFTR channel to help reduce symptoms yet are ineffective in some people with CF because of their underlying mutations. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) to treat Cystic Fibrosis. ARCT-032 utilizes Arcturus' LUNAR®? lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as demonstrating restoration of CFTR expression and function in human bronchial epithelial cells. Announcement • Jul 25
Arcturus Therapeutics Holdings Inc. to Report Q2, 2025 Results on Aug 11, 2025 Arcturus Therapeutics Holdings Inc. announced that they will report Q2, 2025 results at 4:00 PM, Eastern Standard Time on Aug 11, 2025 Announcement • Jul 01
Arcturus Therapeutics Holdings Inc. Announces Positive Interim Phase 2 Multiple Dose Data for Ornithine Transcarbamylase (Otc) Deficiency Program Arcturus Therapeutics Holdings Inc. announced 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. 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. The combined biomarker data is unprecedented for an mRNA therapeutic therapeutic and, importantly, provides a potentially accelerated path forward to a multi-biomarkerdriven pivotal study. 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 15N-ureagenesis assay (Allegri et al., 2025). The assay measures relative ureagenesis function (RUF) against a normal range established from healthy controls (N = 29). 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. Announcement • Jun 24
Arcturus Therapeutics Holdings Inc. to Host Key Opinion Leader Presentation of ARCT-810 Phase 2 Interim Data for Ornithine Transcarbamylase Deficiency Arcturus Therapeutics Holdings Inc. announced that it will host a virtual KOL presentation of ARCT-810 Phase 2 interim data for Ornithine Transcarbamylase (OTC) deficiencyon Monday, June 30, 2025, at 12:00 p.m. ET. The Company will issue a press release summarizing the data at 11 am ET, prior to the presentation. 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. 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. Announcement • Apr 28
Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 06, 2025 Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 06, 2025. Announcement • Apr 23
Arcturus Therapeutics Holdings Inc. to Report Q1, 2025 Results on May 12, 2025 Arcturus Therapeutics Holdings Inc. announced that they will report Q1, 2025 results at 4:00 PM, US Eastern Standard Time on May 12, 2025 Announcement • Apr 10
Arcturus Therapeutics Holdings Inc. Receives U.S. FDA Fast Track Designation for the STARR®? mRNA Vaccine Candidate ARCT-2304 for Pandemic Influenza A Virus H5N1 Arcturus Therapeutics Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, designed for active immunization to protect against disease caused by influenza A H5N1 subtype contained in the vaccine. This designation recognizes the potential of ARCT-2304 as an innovative approach to address unmet medical needs for the prevention of disease caused by pandemic influenza A virus H5N1, a significant global health risk. The Phase 1 clinical study initiated in November 2024. Fast Track Designation from the FDA is granted to vaccines intended to prevent serious conditions caused by infectious disease. The designation is designed to expedite the development and review process, providing several benefits, including enhanced communication with the FDA and eligibility for priority review, and the possibility of a rolling review. ARCT-2304, also known as LUNAR-H5N1, is a STARR®? sa-mRNA vaccine candidate formulated with Arcturus proprietary LUNAR®? delivery technology. The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, thereby enabling lower doses than conventional mRNA vaccines. Utilizing a sa-mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks. Announcement • Feb 25
Arcturus Therapeutics Holdings Inc. to Report Q4, 2024 Results on Mar 06, 2025 Arcturus Therapeutics Holdings Inc. announced that they will report Q4, 2024 results After-Market on Mar 06, 2025 Announcement • Feb 15
CSL and Arcturus Therapeutics Announces Marketing Authorization Grant by European Commission Marketing Authorization for Kostaive (Arct-154), A Self-Amplifying Mrna Covid-19 Vaccine CSL and Arcturus Therapeutics announced that the European Commission has granted marketing authorization for KOSTAIVE (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. KOSTAIVE is the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission (EC). KOSTAIVE is currently marketed in Japan against COVID-19. The European Commission approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024. CSL - including three businesses: CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Announcement • Feb 04
Arcturus Therapeutics Holdings Inc. Appoints Moncef Slaoui as Chair Designate Arcturus Therapeutics Holdings Inc. announced the appointment of Moncef Slaoui, Ph.D., as Chair Designate. Dr. Slaoui has been serving on the Company’s Board of Directors since June 2024. Dr. Moncef Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed. Under his leadership the operation enabled the fastest ever development, manufacturing, and approval of multiple COVID-19 vaccines in less than 11 months after the virus genetic sequence was described. Dr. Slaoui has sat on several biotechnology company boards, including Moderna Inc. and Lonza Group AG, and he chaired the boards of Galvani, and Vaxcyte, a vaccine development platform company. Dr. Slaoui spent nearly 30 years at GlaxoSmithKline (GSK) holding leadership positions including as member of the Board of Directors of GSK PLC; Chairman of Pharmaceutical R&D; Chairman Global R&D, Vaccines & Oncology; and Chairman, Global Vaccines. As Chairman of Pharmaceutical R&D, Dr. Slaoui led a redesign of GSK’s R&D structure and culture to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in GSK's vaccine pipeline, leading to the creation of 14 new vaccines, including Shingrix®, to prevent shingles; Cervarix®, to prevent cervical cancer; Mosquirix, to prevent malaria; Rotarix®, to prevent rotavirus gastroenteritis; and Synflorix, to prevent pneumococcal disease. In 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world. He served on the Advisory Committee to the Director of the NIH from 2011 to 2016 and has advised the U.S. President's Council of Advisors on Science and Technology. Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles, completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine, and was a Professor of Immunology at the University of Mons, Belgium. He received an accelerated Master of Business Administration from IMD, Switzerland in 1998. Announcement • Jan 10
Arcturus Therapeutics Announces Initiation of Phase 1 H5N1 Flu Vaccine Trial Arcturus Therapeutics Holdings Inc. announced the initiation of the Company's Phase 1 study of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate, also known as LUNAR-H5N1, for active immunization to prevent pandemic influenza disease caused by H5N1 virus. The randomized placebo-controlled Phase 1 trial (NCT06602531) is being conducted at multiple sites in the U.S. and designed to enroll approximately 200 healthy adults (120 participants 18-59 years old; 80 participants 60-80 years old). The clinical study is fully funded by Biomedical Advanced Research and Development Authority (BARDA). The primary objective of this initial clinical trial is to evaluate safety and immune responses of three different dose levels and two different vaccination schedules of ARCT-2304 vaccine. Immune responses are measured by hemagglutination inhibition (HAI), virus microne neutralization (MN) and neuraminidase enzyme-linkedlectin assays (ELLA). ARCT-2304 (LUNAR-H5N 1) utilizes clinically validated LUNAR®? delivery and STARR®? mRNA platform technologies. STARR®? mRNA has demonstrated in multiple clinical trials its ability to elicit a robust immune response at very low dose levels, with extended persistence of neutralizing antibodies compared to approved conventional mRNA vaccines. The robust safety database of the LUNAR and STARR technologies have been established through multiple COVID-19 and seasonal influenza vaccine trials, which included more than 20,000 participants and dose ranges from 1 to 20 mcg of mRNA. The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, thereby enabling lower doses than conventional mRNA vaccines. Utilizing a mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks. Announcement • Jan 07
Arcturus Therapeutics Holdings Inc. Announces Initiation of Dosing in Phase 2 Multiple Ascending Dose Studies for Cystic Fibrosis (CF) and Ornithine Transcarbamylase (OTC) Deficiency Arcturus Therapeutics Holdings Inc. announced that the first CF and OTC deficiency participants initiated dosing in December 2024, in the Company’s Phase 2 multiple ascending dose studies. Each participant in the Phase 2 CF study is expected to receive daily treatments of ARCT-032 over a period of 28 days. The first OTC deficient participant receiving 0.5 mg/kg ARCT-810 initiated dosing in December 2024 in the United States. Each participant is expected to receive five intravenous infusions administered over two months. The Company previously announced the completion of the dosing phase (N = 8; 0.3 mg/kg) in a placebo-controlled European study enrolling OTC deficient individuals and expansion of the Phase 2 clinical program of ARCT-810 into the United States with an open-label multiple-dose study. About Cystic Fibrosis: Cystic fibrosis is a life-shortening disease with a worldwide prevalence. Mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene result in a reduction or absence of CFTR protein and/or function in the airways, causing disruption of ion transport necessary to maintain airway surface homeostasis. CF mucus is more difficult to clear, thus clogging the airways and leading to infection, inflammation, and progressive lung damage that may ultimately result in respiratory failure. Standard of care for many CF individuals include CFTR modulators. Nearly 40,000 people in the U.S. and more than 105,000 people worldwide are living with CF. Approximately 15% of individuals with CF do not benefit from CFTR modulator medicines due to absent CFTR protein and/or drug intolerance. About ARCT-032: ARCT-032 is an inhaled investigational mRNA therapeutic designed to express normal functional CFTR in the lungs of individuals with CF. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) to treat cystic fibrosis. ARCT-032 utilizes Arcturus’ LUNAR® lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. Lung disease is the leading cause of morbidity and mortality in people with CF. Expression of a functional copy of the CFTR mRNA in the lungs of people with CF has the potential to restore CFTR activity and mitigate the downstream effects that cause progressive lung disease. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as the demonstration of restoration of CFTR expression and function ex-vivo in human bronchial epithelial cells. 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 that make it difficult for affected patients to remove toxic waste products as proteins are digested. OTC deficiency is caused by mutations in the OTC gene which leads to a non-functional or deficient OTC enzyme. OTC is a critical liver enzyme which catalyzes an early step in the urea cycle, a metabolic process that converts ammonia to urea. This conversion does not occur properly in patients with OTC deficiency. A deficiency of the OTC enzyme in liver cells can result in high blood ammonia levels and may cause seizures, progressive neurocognitive impairment, coma, and death in untreated patients. OTC deficiency is an inherited X-linked disorder that usually presents early in life, but patients with less severe symptoms may present later in life, as adults. There is currently no cure for OTC deficiency, apart from liver transplant. However, this treatment comes with significant risk of complications such as organ rejection, and transplant 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 and treatment with nitrogen scavenging medications to try to prevent patients from accumulating ammonia. 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 from the European Medicines Agency (EMA), including an approved pediatric investigation plan (PIP), and Orphan Drug Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) for the treatment of ornithine transcarbamylase 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 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. Announcement • Nov 12
Arcturus Therapeutics Holdings Inc. Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial Arcturus Therapeutics Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a "Study Can Proceed" notification for the Company's Investigational New Drug (IND) application, ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus. The clinical study is funded by Biomedical Advanced Research and Development Authority (BARDA) and designed to enroll approximately 200 healthy adults in the United States. ARCT-2304 is a sa-mRNA vaccine candidate formulated within a lipid nanoparticle (LNP). The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, thereby enabling lower doses than conventional mRNA vaccines. Utilizing a mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks. Announcement • Nov 01
Arcturus Therapeutics Holdings Inc. to Report Q3, 2024 Results on Nov 07, 2024 Arcturus Therapeutics Holdings Inc. announced that they will report Q3, 2024 results After-Market on Nov 07, 2024 Announcement • Sep 14
Japan's Ministry of Health, Labor and Welfare Approves CSL and Arcturus Therapeutics Holdings Inc.'s Updated Self-Amplifying mRNA Covid-19 Vaccine for Protection Against JN.1 Strain CSL and Arcturus Therapeutics Holdings Inc. announced that Japan's Ministry of Health, Labor and Welfare (MHLWs) granted approval and authorization for their updated self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, KOSTAIVE. The updated vaccine is targeted to protect against the JN.1 lineage of Omicron subvariants for adults 18 years of age and older. CSL's exclusive partner in Japan, Meiji Seika Pharma, will begin distributing the updated vaccine in time for the October COVID-19 vaccination campaign, marking the commercially available sa-mRNA COVID-19 vaccine for adults 18 and older. In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated to target the JN.1 lineage of Omicron subvariants for the 2024/2025 national immunization program. This aligns with recent recommendations from the World Health Organization. The approval is based on clinical evidence supporting the safety and effectiveness of CSL and Arcturus Therapeutics’ sa-mRNA COVID-19 vaccine, including published data demonstrating superior immunogenicity to Omicron BA 4/5 compared to a conventional mRNA COVID-19 vaccine booster and follow-up data demonstrating duration of immunity lasting up to one year. Announcement • Sep 03
Arcturus Therapeutics Holdings Inc. Receives Clearance of an Investigational New Drug Application to U.S. Food and Drug Administration for ARCT-032, an Investigational Inhaled mRNA Therapeutic to Treat Cystic Fibrosis Arcturus Therapeutics Holdings Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a "Study May Proceed" notification for the Company's Investigational New Drug (IND) application, ARCT-032, to treat cystic fibrosis (CF). FDA clearance of the ARCT-032 IND application enables the Company to initiate a Phase 2 multiple ascending dose study to evaluate the safety, tolerability and efficacy of ARCT-032 in people with Cystic Fibrosis. Cystic fibrosis is a life-shortening disease with a worldwide prevalence. Mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene result in a reduction or absence of CFTR protein and/or function in the airways, causing insufficient chloride transport to maintain airway surface homeostasis. CF mucus is more difficult to clear, thus clogging the airways and leading to infection, inflammation, respiratory failure, or other life-threatening complications. Standard of care for many CF individuals include CFTR modulators. Nearly 40,000 people in the U.S. and more than 105,000 people worldwide are living with CF. Approximately 15% of individuals with CF do not benefit from CFTR modulator medicines due to dysfunctional or absent CFTR protein and/or drug intolerance. ARCT-032 is an inhaled investigational mRNA therapeutic designed to express normal functional CFTR in the lungs of individuals with CF. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation along with Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) to treat cystic fibrosis. ARCT-032 utilizes Arcturus' LUNAR lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. Lung disease is the leading cause of morbidity and mortality in people with CF. Expression of a functional copy of the CFTR mRNA in the lungs of people with CF has the potential to restore CFTR activity and mitigate the downstream effects that cause progressive lung disease. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as demonstrating restoration of CFTR expression and function in human bronchial epithelial cells. Announcement • Jul 19
Arcturus Therapeutics Holdings Inc. to Report Q2, 2024 Results on Aug 05, 2024 Arcturus Therapeutics Holdings Inc. announced that they will report Q2, 2024 results After-Market on Aug 05, 2024 Announcement • Jul 02
Arcturus Therapeutics Holdings Inc. Provides Updates for Ornithine Transcarbamylase (OTC) Deficiency and Cystic Fibrosis (CF) Programs Arcturus Therapeutics Holdings Inc. announced it is providing mid-year updates for ARCT-810, an investigational mRNA therapeutic to treat ornithine transcarbamylase (OTC) deficiency, and ARCT-032, an investigational inhaled mRNA therapeutic to treat cystic fibrosis (CF). ARCT-810 (OTC Deficiency) Update: The double blind ARCT-810 Phase 2 study in the EU and UK has completed enrollment of eight (8) subjects, including adolescents and adults, at the 0.3 mg/kg dose level. The participants in this group are randomized 3:1 and receive 6 doses of ARCT-810 or placebo administered every 14 days. Treatment and follow-up are ongoing with the safety and complete set of biomarker data expected later this year. ARCT-810 is expanding the Company’s clinical program in the U.S. by enrolling patients with more severe disease. Patient screening has been initiated and the Company expects the Phase 2 clinical program to be completed in the United States. More details pertaining to the U.S. trial expansion and interim data will be provided later this year. ARCT-032 (CF) Update: The Company plans to submit an IND application in the next 60 days for an ARCT-032 Phase 2 multiple ascending dose study designed to identify a safe and effective dose in Class I (null) and other CF participants who do not benefit from CFTR modulators. This study is supported by safety and tolerability data collected in healthy volunteers (N = 32) and the ongoing two-administration Phase 1b study. No serious adverse events (SAEs) have been observed in any clinical trial participants to date. No febrile reactions have been observed within the target dose range of the planned Phase 2 study. The Phase 1b study is ongoing with the seventh and final participant scheduled to be dosed soon. Of the seven total CF participants in Phase 1b, six are receiving CFTR modulator treatment while one subject has Class I mutations and therefore does not benefit from modulator therapy. The Class I CF subject had low lung function at baseline (ppFEV1 below 50%) and showed an improvement of 4% in ppFEV1 on Day 8, after receiving two well-tolerated administrations, with no febrile reactions. Announcement • Jun 20
Arcturus Therapeutics Holdings Inc. Appoints Moncef Slaoui, Ph.D., to Board of Directors Arcturus Therapeutics Holdings Inc. announced the appointment of a new independent director, Moncef Slaoui, Ph.D., to the Company's Board of Directors. Dr. Moncef Slaoui was most recently the Chief Scientific Advisor to Operation Warp Speed. Under his leadership the operation enabled the fastest ever development, manufacturing, and approval of multiple COVID-19 vaccines in less than 11 months after the virus genetic sequence was described. Dr. Slaoui has sat on several biotechnology company boards, including Moderna Inc. and Lonza Group AG, and he chaired the boards of Galvani, and Vaxcyte, a vaccine development platform company. Dr. Slaoui spent nearly 30 years at GlaxoSmithKline (GSK) holding leadership positions including as member of the Board of Directors of GSK PLC; Chairman of Pharmaceutical R&D; Chairman Global R&D, Vaccines & Oncology; and Chairman, Global Vaccines. As Chairman of Pharmaceutical R&D, Dr. Slaoui led a restructuring to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in GSK's vaccine pipeline, leading to the creation of 14 new vaccines, including Shingrix®, to prevent shingles; Cervarix®, to prevent cervical cancer; Mosquirix, to prevent malaria; Rotarix®, to prevent rotavirus gastroenteritis; and Synflorix, to prevent pneumococcal disease. In 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world, served on the Advisory Committee to the Director of the NIH from 2011 to 2016, and has advised the U.S. President's Council of Advisors on Science and Technology. Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles, completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine, and was a Professor of Immunology at the University of Mons, Belgium. He received an accelerated Master of Business Administration from IMD, Switzerland in 1998. Announcement • May 29
Arcturus Therapeutics Holdings Inc. Announces Positive Development for Cystic Fibrosis Program Arcturus Therapeutics Holdings Inc. announced ARCT-032 will be presenting Phase 1 results in healthy volunteers and new Phase 1b interim data in CF patients for ARCT-032, an inhaled investigational mRNA therapeutic to treat CF, at the 47thEuropean Cystic Fibrosis Conference on June 7, 2024. Arcturus will be presented Phase 1 results in healthy volunteers. ARCT-032 has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) to treat Cystic Fibrosis. ARCT-032 utilizes Arcturus' LUNAR lipid-mediated aerosolized platform to deliver CFTR messenger RNA to the lungs. The ARCT-032 program is supported by preclinical data in rodents, ferrets and primates, as well as demonstrating restoration of CFTR expression and function in human bronchial epithelial cells. New Risk • May 28
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. This is currently the only risk that has been identified for the company. Announcement • May 23
Nature Communications Publishes Pivotal Data Demonstrating Efficacy and Tolerability of CSL and Arcturus Therapeutics' COVID-19 Vaccine CSL and Arcturus Therapeutics announced Nature Communications has published results from an integrated phase 1/2/3a/3b study evaluating the safety, immunogenicity, and efficacy of ARCT, 154, a novel self-amplifying (sa-mRNA) COVID-19 vaccine and the world's first approved sa-mRNA COVID-19 vaccine. The results demonstrate that two 5 mg doses of ARCT-154, sa-mRNA vaccine, were well-tolerated, immunogenic and provided significant protection against multiple strains of COVID-19. The efficacy of ARCT-154 against severe COVID-19 was 100% in healthy persons aged 18-59 and more than 90% in persons at risk of severe consequences of the disease due to co-morbidities or older age. During the observer-blind, randomized, controlled phase 1, 2, 3a and 3b integrated study, adults =18 years old receive two 5 µg doses of ARCT-154 or saline placebo 28 days apart. Phase 2/3a/3b participants were stratified by age (< 60 or = 60 years of age) and by risk of severe COVID-19 prior to being randomized 3:1 (phase 1/2/3a) or 1:1 (phase 3b) to vaccine or placebo groups. The primary endpoints were vaccine efficacy up to 2 months after dose 2, reactogenicity within up to 7 days of each dose, safety within up to 28 days after each dose, and immunogenicity measured 28 days after each dose From August 15 to January 12, 2023, 1,001 participants were randomized (748 ARCT-154 and 253 placebo) in the integrated phase 1/2/3a study, and 16,100 participants (8,056 ARCT-154 and 8,044 placebo) in the phase 3b study. In the phase 1/2/3a studies, ARCT-154 was safe and well tolerated. Most solicited adverse events were mild or moderate and resolved quickly, and rates of related or severe unsolicited adverse events were similar in the ARCT-154 and placebo groups. The phase 3b study confirmed these observations. Four weeks after the second ARCT-154 dose in phase 3b, the neutralizing antibody seroconversion rate was 94.1% (95% CI: 92•1–95•8). There were 640 confirmed, protocol-defined COVID-19 cases, mainly of the Delta variant, that were determined to be eligible for analysis, including 43 severe cases and 10 deaths attributed to COVID-19. ARCT-154 absolute efficacy was 56.6% (95% CI: 48.7– 63.3) against any COVID-19, 95•3% (80.5–98.9) against severe COVID-19 and 86.5% (-7.4–98.3) against death due to COVID-19. Efficacy against severe COVID-19 was 100% in healthy 18-59-year-olds and 91.9% (37.9-98.9) in participants in that age group with underlying co-morbidities, which put them at risk for severe disease. In adults aged 60 years or older, efficacy was 54.3% (28.2–70.9) against COVID-19 of any severity and 94.4% (58.2–99.3) against severe COVID-19. Major Estimate Revision • May 15
Consensus revenue estimates increase by 24%, EPS downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$147.0m to US$181.8m. EPS estimate fell from -US$2.61 to -US$2.99 per share. Biotechs industry in the US expected to see average net income decline 9.7% next year. Consensus price target up from US$67.93 to US$72.29. Share price rose 6.6% to US$29.02 over the past week. Reported Earnings • May 09
First quarter 2024 earnings: EPS and revenues exceed analyst expectations First quarter 2024 results: US$1.00 loss per share (down from US$1.91 profit in 1Q 2023). Revenue: US$38.0m (down 53% from 1Q 2023). Net loss: US$26.8m (down 153% from profit in 1Q 2023). Revenue exceeded analyst estimates by 115%. Earnings per share (EPS) also surpassed analyst estimates by 19%. Revenue is forecast to grow 41% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 64% per year but the company’s share price has only increased by 2% per year, which means it is significantly lagging earnings growth. Announcement • May 01
Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 14, 2024 Arcturus Therapeutics Holdings Inc., Annual General Meeting, Jun 14, 2024, at 09:00 Pacific Standard Time. Agenda: To elect Dr. Peter Farrell, Joseph E. Payne, Andy Sassine, James Barlow, Dr. Edward W. Holmes, Dr. Magda Marquet, Dr. Jing L. Marantz, and Dr. John Markels to the Board of Directors (the “Board”), to serve until our next annual meeting of stockholders; to approve an amendment to the Amended and Restated 2019 Omnibus Equity Incentive Plan (as amended, the “Plan”) to, among other things, increase the maximum number of shares of common stock available to Plan participants thereunder by 2,000,000 shares to an aggregate of 10,750,000 shares; to approve, on a non-binding advisory basis, the resolution approving named executive officer compensation; to ratify the appointment of Deloitte & Touche LLP (“Deloitte”), as an independent registered public accounting firm for the fiscal year ending December 31, 2024; and to transact other business that may properly come before the annual meeting. Announcement • Apr 28
Arcturus Therapeutics Holdings Inc. to Report Q1, 2024 Results on May 08, 2024 Arcturus Therapeutics Holdings Inc. announced that they will report Q1, 2024 results After-Market on May 08, 2024 Major Estimate Revision • Mar 24
Consensus EPS estimates fall by 20% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$166.7m to US$150.8m. Losses expected to increase from US$2.05 per share to US$2.46. Biotechs industry in the US expected to see average net income decline 9.2% next year. Consensus price target of US$67.89 unchanged from last update. Share price fell 6.6% to US$33.90 over the past week. Recent Insider Transactions Derivative • Mar 21
Founder notifies of intention to sell stock Padmanabh Chivukula intends to sell 26k shares in the next 90 days after lodging an Intent To Sell Form on the 19th of March. If the sale is conducted around the recent share price of US$35.00, it would amount to US$910k. Since June 2023, Padmanabh's direct individual holding has decreased from 549.45k shares to 499.45k. Company insiders have collectively sold US$315k more than they bought, via options and on-market transactions in the last 12 months. Major Estimate Revision • Mar 14
Consensus EPS estimates upgraded to US$2.19 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -US$3.33 to -US$2.19 per share. Revenue forecast steady at US$163.2m. Biotechs industry in the US expected to see average net income decline 8.3% next year. Consensus price target up from US$66.33 to US$67.89. Share price was steady at US$37.90 over the past week. Reported Earnings • Mar 09
Full year 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2023 results: US$1.00 loss per share (down from US$0.35 profit in FY 2022). Revenue: US$169.9m (down 18% from FY 2022). Net loss: US$26.6m (down 384% from profit in FY 2022). Revenue missed analyst estimates by 2.2%. Earnings per share (EPS) exceeded analyst estimates by 35%. Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 70% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings. Valuation Update With 7 Day Price Move • Feb 28
Investor sentiment improves as stock rises 22% After last week's 22% share price gain to US$42.99, the stock trades at a trailing P/E ratio of 11.6x. Average trailing P/E is 14x in the Biotechs industry in the US. Total loss to shareholders of 15% over the past three years. Announcement • Feb 21
Arcturus Therapeutics Holdings Inc. to Report Q4, 2023 Results on Mar 07, 2024 Arcturus Therapeutics Holdings Inc. announced that they will report Q4, 2023 results After-Market on Mar 07, 2024 Price Target Changed • Feb 09
Price target increased by 8.0% to US$66.33 Up from US$61.44, the current price target is an average from 9 analysts. New target price is 75% above last closing price of US$37.91. Stock is up 100% over the past year. The company is forecast to post a net loss per share of US$1.53 compared to earnings per share of US$0.35 last year. Announcement • Dec 21
CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicronba BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster Booster CSL and Arcturus Therapeutics announced the publication in Lancet Infectious Diseases of a Phase 3 study showing that a booster dose of ARCT-154, a novel, self-amplifying messenger RNA (sa-mRNA) vaccine, expedited a numerically higher immune response (meeting the non-inferiority criteria) against the original Wuhan-Hu-1 virus strain, and a superior immune response against Omicron BA.4/5 subvariant of SARS-CoV-2 virus compared to a booster dose of the conventional mRNA vaccine Comirnaty. The study included healthy adults initially immunized with two doses of an mRNA vaccine (Comirnaty or Spikevax); and then a third dose of Comirnaty at least three months prior to the booster dose of either ARCT-154 or Comirnaty in the study. Both vaccines were well-tolerated, with no causally associated severe or serious adverse events. The study was conducted in partnership with Meiji Seika Pharma, a global health company based in Japan. The phase 3 study results with ARCT-154 were used to support the approval of ARCT-154 for primary immunization and as a booster dose in Japan in November of this year. The ARCT-154 study is ongoing and will continue to collect safety data and assess durability of the immune response in participants at 3-, 6- and 12-months post-vaccination. The randomized, double-blind, active-controlled study, conducted at 11 sites in Japan, was designed to compare the immunogenicity and tolerability of the sa-mRNA vaccine ARCT-154 with authorized mRNA COVID-19 vaccine Comirnaty. Investigators compared immune responses to ARCT-154 and Comirnaty booster doses in healthy Japanese adults 18 years of age or older initially immunized with two dose of mRNA COVID-19 vaccine (Comirnaty or Spikevax) and then a third dose ofComirnaty at least three months prior to receiving a booster dose of one of the study vaccines. Valuation Update With 7 Day Price Move • Dec 20
Investor sentiment improves as stock rises 25% After last week's 25% share price gain to US$32.41, the stock trades at a trailing P/E ratio of 8.7x. Average forward P/E is 18x in the Biotechs industry in the US. Total loss to shareholders of 68% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$47.95 per share. Announcement • Nov 29
Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the First Self-Amplifying mRNA Vaccine Approves for COVID in Adults CSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval forARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. The approval is based on positive clinical data from several ARCT-154 studies, including an ongoing 16,000 subject efficacy study performed in Vietnam as well as a Phase 3 COVID-19 booster trial, which achieved higher immunogenicity results and a favorable safety profile compared to a standard mRNA COVID-19 vaccine comparison. Initial study results have been published in MedRxiv and are expected to be published in a peer-reviewed journal by the end of the year. CSL's vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, partnered exclusively with Meiji Seika Pharma for distribution of the sa-mRNA COVID vaccine, ARCT 154, in Japan. Major Estimate Revision • Nov 22
Consensus revenue estimates increase by 27% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$136.7m to US$174.0m. Forecast losses expected to reduce from -US$2.84 to -US$1.54 per share. Biotechs industry in the US expected to see average net income growth of 10% next year. Consensus price target broadly unchanged at US$61.44. Share price was steady at US$22.94 over the past week. Reported Earnings • Nov 16
Third quarter 2023 earnings: EPS and revenues exceed analyst expectations Third quarter 2023 results: US$0.61 loss per share (improved from US$1.33 loss in 3Q 2022). Revenue: US$45.1m (up 238% from 3Q 2022). Net loss: US$16.2m (loss narrowed 54% from 3Q 2022). Revenue exceeded analyst estimates by 185%. Earnings per share (EPS) also surpassed analyst estimates by 63%. Revenue is expected to decline by 1.4% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 15%. Over the last 3 years on average, earnings per share has increased by 61% per year but the company’s share price has fallen by 26% per year, which means it is significantly lagging earnings. Announcement • Oct 26
Arcturus Therapeutics Holdings Inc. to Report Q3, 2023 Results on Nov 14, 2023 Arcturus Therapeutics Holdings Inc. announced that they will report Q3, 2023 results After-Market on Nov 14, 2023 Recent Insider Transactions Derivative • Oct 04
Founder notifies of intention to sell stock Padmanabh Chivukula intends to sell 15k shares in the next 90 days after lodging an Intent To Sell Form on the 2nd of October. If the sale is conducted around the recent share price of US$26.00, it would amount to US$390k. Since March 2023, Padmanabh's direct individual holding has decreased from 589.45k shares to 509.45k. Company insiders have collectively sold US$233k more than they bought, via options and on-market transactions in the last 12 months. Announcement • Sep 06
Arcturus Therapeutics Holdings Inc. and Csl Seqirus Announce European Medicines Agency Validates Marketing Authorization Application for Arct-154 Vaccine to Prevent Covid-19 Arcturus Therapeutics Holdings Inc. and CSL announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for ARCT-154, a next generation mRNA vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The companies (Arcturus and CSL Seqirus) anticipate an approval decision by the European Commission in 2024. The EMA submission is based on successful Phase 3 clinical results of ARCT-154 against the ancestral D614G variant as a primary series and booster. In an analysis of 6-month data from the pivotal Phase 3 study, the primary efficacy endpoint was met and ARCT-154 as a primary series resulted in 56.6% efficacy for prevention of symptomatic COVID-19 overall, and 95.3% efficacy for prevention of severe COVID-19 including COVID-19 related deaths. The study was conducted when Delta variant was dominant in Vietnam. The booster data result was previously announced by CSL Seqirus' partner, Meiji Seika Pharma, indicating that the primary endpoint was achieved in a Phase 3 booster vaccine study by demonstrating non-inferiority of immune response against SARS-CoV- 2 ancestral strain compared to Comirnaty®?. Superiority of ARCT-154 in neutralizing antibody response against SARS- CoV-2 Omicron BA.4/5 variant was a key secondary endpoint. The unique combination of commercial strength, R&D focus and operational excellence enables to identify, develop and deliver innovations so patients can live life to the fullest. Recent Insider Transactions Derivative • Sep 03
Founder notifies of intention to sell stock Padmanabh Chivukula intends to sell 5k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of September. If the sale is conducted around the recent share price of US$31.00, it would amount to US$155k. Since March 2023, Padmanabh's direct individual holding has decreased from 589.45k shares to 514.45k. Company insiders have collectively sold US$233k more than they bought, via options and on-market transactions in the last 12 months. Valuation Update With 7 Day Price Move • Aug 15
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to US$29.94, the stock trades at a trailing P/E ratio of 9.9x. Average forward P/E is 12x in the Biotechs industry in the US. Total loss to shareholders of 47% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$48.37 per share. Major Estimate Revision • Aug 14
Consensus revenue estimates fall by 17% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$174.9m to US$145.5m. Forecast losses increased from -US$0.697 to -US$2.16 per share. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target of US$60.44 unchanged from last update. Share price fell 13% to US$27.77 over the past week. 
