SAN DIEGO--(BUSINESS WIRE)--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced its financial results for the fourth quarter ended December 31, 2023, and provided corporate updates. “I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” sai ...

Revenue Performance - Arcturus reported revenue of $169.9 million for the year ended December 31, 2023, a decrease from $206.0 million in 2022, primarily due to the discontinuation of collaborations with Vinbiocare and Janssen[4] - Revenue from CSL in 2023 was $157.4 million, slightly increasing by $3.0 million compared to 2022[4] - Total revenue for 2023 was $169.933 million, a decrease of 17.5% from $205.999 million in 2022[17] - Collaboration revenue for 2023 was $160.882 million, down from $205.755 million in 2022, representing a decline of 22%[17] Operating Expenses - Total operating expenses for 2023 were $245.0 million, up from $193.8 million in 2022[5] - Research and development expenses increased to $192.1 million in 2023 from $147.8 million in 2022, driven by CSL and BARDA programs[6] - Research and development expenses increased to $192.133 million in 2023, up 30% from $147.751 million in 2022[17] - Operating expenses for the three months ended December 31, 2023, were $49.127 million, compared to $38.841 million for the same period in 2022[19] Net Income and Loss - The net loss for 2023 was approximately $26.6 million, or ($1.00) per diluted share, compared to a net income of $9.3 million, or $0.35 per diluted share in 2022[8] - Net loss for 2023 was $26.591 million, compared to a net income of $9.349 million in 2022[17] - Basic and diluted loss per share for 2023 was $(1.00), compared to earnings of $0.35 per share in 2022[17] - Net loss for the three months ended December 31, 2023, was $8.573 million, compared to a net income of $117.347 million for the same period in 2022[19] Cash and Assets - Cash, cash equivalents, and restricted cash were $348.9 million at December 31, 2023, down from $394.0 million at the end of 2022[9] - Total current assets decreased to $386.590 million as of December 31, 2023, from $403.333 million at the end of 2022[15] - Total liabilities decreased to $147.755 million as of December 31, 2023, from $180.075 million at the end of 2022[15] - Total assets decreased to $429.402 million as of December 31, 2023, from $450.387 million at the end of 2022[15] Future Developments - The cash runway has been extended to Q1 2027 due to disciplined cost management and progress in collaborations[2] - Kostaive® is anticipated to launch in Japan in 2024, marking a significant milestone as the world's first self-amplifying mRNA product approved for COVID-19[3] - ARCT-032 received Orphan Drug Designation from the U.S. FDA and the European Commission, with Phase 1b interim data expected in Q2 2024[2] - New vaccine discovery programs for Lyme Disease and Gonorrhea have been initiated based on the validation of LUNAR® and STARR® technologies[3]

Shares of Arcturus Therapeutics Holdings Inc. (ARCT) have surged 73% in the past three months compared with the industry’s growth of 10.5%.Last month, the European Commission granted orphan medicinal product designation to the company’s product candidate ARCT-032 for the treatment of cystic fibrosis (CF). The designation is likely to support the development of ARCT-032, including certain protocol assistance, access to the centralized authorization procedure, exemption from fees and research funding, along w ...

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SAN DIEGO--(BUSINESS WIRE)--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and medicines to treat unmet medical needs within liver and respiratory rare diseases, today announced that the European Commission (EC), based on a positive opinion issued by the European Medicines Agency (EMA), has granted orphan medicinal product designation for the Company’s produc ...

Core Insights - The article emphasizes the significant potential of AI and technology sectors, highlighting their capacity for transformative growth and innovation in various aspects of life [1] Group 1: Arcturus Therapeutics Holdings (ARCT) - Arcturus Therapeutics is a biotechnology company focused on treatments for COVID-19 and influenza, with a one-year stock price prediction ranging from $18 to $140, averaging $65.25 [2] - The company announced a successful COVID-19 vaccine booster that enhances immunity duration and antibody strength, positioning it as a key player in future vaccine rollouts [2] - Arcturus has a low P/E ratio of 9.82x compared to the industry average of 16.38x, with a YoY revenue growth of 30% and an impressive YoY EPS growth of 974% [3] Group 2: Cisco Systems (CSCO) - Cisco Systems is a communications technology company with a one-year stock price forecast between $43 and $76, averaging $53.47 [4] - The company has partnered with Microsoft to upgrade transatlantic cables to support cloud and AI services, indicating its commitment to future growth in these areas [5] - Cisco's P/E ratio stands at 14.72x, significantly lower than the industry average of 30x, with a YoY EPS growth of approximately 7% [5] Group 3: SurgePays (SURG) - SurgePays is a telecommunications and financial technology company targeting unbanked populations, with a one-year price target between $13.25 and $15 [6] - The company is expanding its presence in convenience stores, which is expected to enhance recurring revenues and customer loyalty [6] - SurgePays reported a significant improvement in profitability, with EBITDA rising from a loss of -$0.8 million to $7.5 million and gross profit margin increasing from 5.3% to 30.7% [7]

Study conducted by Meiji Seika Pharma in Japan Short communication follows previously published data in The Lancet Infectious Diseases demonstrating Immunological Non-Inferiority to Wuhan Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster  New data demonstrates continuous advantage of sa-mRNA over conventional mRNA vaccine in terms of duration of immune response These results follow approval of the world's first sa-mRNA COVID-19 vaccine for adults ...

Core Viewpoint - Arcturus Therapeutics Holdings Inc. is positioned as a promising biotechnology company with proprietary mRNA technology platforms, focusing on rare and infectious diseases, and is rated a "buy" due to its strong financial position and potential in cystic fibrosis and COVID-19 vaccine development [2][24]. Company Overview - Arcturus Therapeutics, founded in 2013 and headquartered in San Diego, specializes in treatments for rare and infectious disorders, utilizing proprietary platforms LUNAR and STARR for mRNA delivery and self-amplifying mRNA technology [3][5]. - The LUNAR platform employs lipid nanoparticles for mRNA delivery, enhancing stability and minimizing immune response, while the STARR platform allows for self-replicating mRNA, enabling lower doses and fewer side effects [5][6]. Product Pipeline - The company is advancing two key therapies: LUNAR-OTC (ARCT-810) for Ornithine Transcarbamylase Deficiency, currently in Phase 2 trials, and LUNAR-CF (ARCT-032) for Cystic Fibrosis, which is in Phase 1b trials [6][9]. - Cystic Fibrosis affects 85,000-100,000 individuals globally, and ARCT-032 aims to restore CFTR function, addressing significant unmet medical needs in CF treatment [8][9]. COVID-19 Vaccine Development - Arcturus has developed a COVID-19 vaccine approved in Japan, with a Marketing Authorization Application filed in the EU, and is collaborating with CSL on multiple mRNA vaccines, valued at up to $4.5 billion [10][12]. - The CSL partnership includes a $200 million upfront payment, $1.3 billion for development milestones, and $3.0 billion for commercial milestones, with a profit-sharing agreement [11][12]. Financial Position - Arcturus has a market cap of approximately $881.07 million, with projected revenues of $157.06 million for 2024, resulting in a forward P/S multiple of about 5.61, which is above the sector median [21]. - The company is cash-positive, holding around $311.9 million in cash against $51.2 million in debt, indicating a solid financial foundation for ongoing research and development [22]. Strategic Focus - The company’s strategic focus on forming productive partnerships, particularly in Japan, enhances its vaccine research and commercialization efforts, potentially leading to significant shareholder value [16][24]. - Upcoming interim data for ARCT-810 and ARCT-032 in the first half of 2024 could serve as a catalyst for stock performance, depending on trial outcomes [9][21].

fatido/E+ via Getty Images Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) is gearing up to report results from its phase 1b study using its inhaled messenger RNA [mRNA] treatment known as ARCT-032 for the treatment of patients with Cystic Fibrosis [CF]. There is an important catalyst to watch with respect to this program, which is that there will be the release of interim results from this phase 1b study in the 1st half of 2024. What makes this biotech unique is that its approach to treating this patient ...

Financial Data and Key Metrics Changes - For Q3 2023, revenues were reported at $45.1 million, a significant increase from $13.4 million in Q3 2022, representing a year-over-year increase of $31.7 million [19] - Total operating expenses for Q3 2023 were $64.5 million, compared to $50.2 million in Q3 2022, indicating an increase in expenses [20] - The net loss for Q3 2023 was approximately $16.2 million, or $0.61 per diluted share, an improvement from a net loss of $35.3 million, or $1.33 per diluted share, in Q3 2022 [22] Business Line Data and Key Metrics Changes - The ARCT-154 COVID-19 vaccine is under review by Japan's PMDA, with a new drug application supported by successful Phase 3 studies [5][7] - The ongoing Phase 3 bivalent COVID vaccine trial has reached its enrollment target of 850 participants, with initial top-line results expected in Q1 2024 [8] - The ARCT-810 program for OTC deficiency has received Orphan Drug Designation and is currently in two clinical studies, with interim data expected in H1 2024 [11][12] Market Data and Key Metrics Changes - The company has achieved approximately $365 million in upfront payments and milestones from CSL Seqirus as of September 30, 2023, which supports ongoing development activities [22] - The cash runway is expected to extend through the end of 2026 based on the current pipeline and program [23] Company Strategy and Development Direction - The strategic collaboration with CSL Seqirus focuses on developing and commercializing next-generation mRNA vaccines, with significant progress reported [9] - The company is committed to enhancing the STARR next-generation mRNA vaccine platform, which aims to provide a longer-lasting immune response compared to conventional mRNA technologies [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the approval of ARCT-154 in Japan, which is anticipated in December 2023, marking a critical milestone for the company [24] - The management acknowledged the challenges in patient recruitment for the ARCT-810 program but emphasized efforts to enhance patient experience and recruitment strategies [38] Other Important Information - The ARCALIS facility in Japan is expected to become a key player in the global mRNA drug manufacturing landscape, with significant government funding supporting its development [17][18] - The company is exploring the potential for inhaled vaccines for respiratory viruses, leveraging its existing technologies [63] Q&A Session Summary Question: Update on Japan's vaccine order commitment for 2024 - Management indicated that Meiji is responsible for soliciting orders and that no orders can be placed until approval is granted [27] Question: Timeline for bivalent vaccine data - Top-line data for the bivalent vaccine is expected in Q1 2024, with anticipated PMDA approval in Q3 2024 [27] Question: Concerns about patient recruitment for the OTC program - Management acknowledged the slow recruitment but highlighted measures taken to enhance patient experience and recruitment efforts [38] Question: Clarification on regulatory conversations regarding ARCT-154 - Management confirmed that the six-month durability data was shared with the regulatory agency and is being considered for approval [30] Question: Expectations for EMA feedback on ARCT-154 - Management stated that the EMA approval process is considerable, with guidance from CSL indicating a 2024 approval [57] Question: Potential for developing inhaled vaccines - Management noted that the success in large vaccine trials could present opportunities for combining technologies for inhaled vaccines [63]