Arcturus Therapeutics Holdings Inc (ARCT)

Arcturus Therapeutics Announces Strategic Collaboration with Thermo Fisher Scientific to Advance ARCT-032 for Cystic FibrosisJuly 2, 2026 7:00 AM
Business Wire Strategic manufacturing agreement includes Phase 3 clinical supply and commercial manufacturing rights Arcturus Therapeutics Holdings Inc. (“Arcturus”, Nasdaq: ARCT), a messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics, today announced a strategic collaboration with Thermo Fisher Scientific, the world leader in serving science, to help support the Phase 3 development and potential commercialization of ARCT-032, Arcturus’ investigational mRNA therapy for Cystic Fibrosis. The collaboration will leverage Thermo Fisher's Accelerator™ Drug Development solutions, combining manufacturing and clinical research capabilities to support Phase 3 development through potential commercialization. Thermo Fisher will provide integrated manufacturing, clinical research, and commercial readiness services to help accelerate development of ARCT-032 while Arcturus continues to advance the program. “We are pleased to collaborate with Thermo Fisher to utilize its impressive CDMO capabilities, global infrastructure, and proven ability to support complex mRNA programs from Phase 3 through potential commercialization,” said Joseph Payne, President and Chief Executive Officer of Arcturus Therapeutics. “Their capabilities are aligned with Arcturus’ goal of efficiently advancing our cystic fibrosis program into Phase 3 and preparing for potential commercial supply.” “Biotechnology innovators increasingly seek strategic collaborators that can support complex development programs across clinical and commercial stages,” said Mike Shafer, Executive Vice President and President, Biopharma Services, Thermo Fisher Scientific. “Through Accelerator™ Drug Development, Thermo Fisher brings together manufacturing, clinical research, and commercialization expertise to help customers simplify development, reduce operational complexity, and accelerate the delivery of innovative therapies to patients. Our collaboration with Arcturus demonstrates the value of this integrated model.” Under the agreement, Thermo Fisher will provide Phase 3 manufacturing, clinical research, and related services. If Phase 2 yields positive results, Arcturus expects to conduct its Phase 3 program through Thermo Fisher's PPD™ clinical research business. Subject to regulatory approval of ARCT-032, Thermo Fisher will receive exclusive commercial manufacturing rights under a separate commercial agreement. About Arcturus Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration with CSL Seqirus, U.S. BARDA for pandemic flu and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA (siRNA), circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 500 patents and patent applications in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com. Please connect with us on X 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, likelihood of continuation of and positive results of the ongoing Phase 2 clinical of ARCT-032, the likelihood, timing of and ability to initiate a Phase 3 of ARCT-032, commercialization potential of ARCT-032, the likelihood of successful collaboration with Thermo Fisher on the strategic collaboration, the likelihood that the Company and Thermo Fisher will be able to agree upon ancillary agreements related to the collaboration, including commercial supply terms, likelihood of regulatory approval of ARCT-032, the potential commercial supply of ARCT-032, 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 U.S. Securities and Exchange Commission (the “SEC”), which are available on the SEC’s website at www.sec.gov. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20260702861323/en/ Arcturus Therapeutics
Public Relations & Investor Relations
Neda Safarzadeh
VP, Head of IR/PR/Marketing
(858) 900-2682
IR@ArcturusRx.com Original: Arcturus Therapeutics Announces Strategic Collaboration with Thermo Fisher Scientific to Advance ARCT-032 for Cystic Fibrosis

Arcturus Therapeutics to Present at 2026 Jefferies Global Healthcare ConferenceMay 26, 2026 4:01 PM
Business Wire Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics, today announced that the Company will present at the following investor conference in New York: 2026 Jefferies Global Healthcare Conference (Presentation) Thursday, June 4, 2026 (9:20 a.m. ET) Webcast link can be found under Investor Relations/Events section of Arcturus’ website. About Arcturus Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration with CSL Seqirus, U.S. BARDA for pandemic flu and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA (siRNA), circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 500 patents and patent applications in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com. Please connect with us on X and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/20260526805188/en/ Arcturus Therapeutics
Public Relations & Investor Relations
Neda Safarzadeh
VP, Head of IR/PR/Marketing
(858) 900-2682
IR@ArcturusRx.com Original: Arcturus Therapeutics to Present at 2026 Jefferies Global Healthcare Conference

When Science Becomes an Asset: How Advancing Drug Pipelines Are Driving Real-Time Valuation in BiotechApril 20, 2026 9:00 AM
InvestorsHub NewsWireWhen Science Becomes an Asset: How Advancing Drug Pipelines Are Driving Real-Time Valuation in BiotechBioMedWire Editorial Coverage: Biotechnology is undergoing a quiet but profound transformation, one that is reshaping how investors understand value in a sector historically defined by long timelines and uncertain outcomes. As drug candidates advance closer to commercialization, scientific progress is no longer viewed solely as research expenditure but increasingly as a measurable financial asset. This shift is being reinforced by fair-value accounting under U.S. GAAP, which allows life sciences companies to reflect clinical progress, probability of success and commercialization timing as measurable balance sheet value. Leading companies, such as Oncotelic Therapeutics Inc. (OTCQB: OTLC) (Profile), are keenly aware of this evolution and are leveraging their expertise as pioneers in this space. Through its diversified pipeline and strategic holdings, including a 45% ownership stake in GMP Bio, which was recently measured at more than $1 billion enterprise value, the company exemplifies how advancing science can directly influence financial positioning. As the biotech sector increasingly aligns valuation with progress rather than revenue alone, Oncotelic provides a case study in how innovation is becoming a recognized asset class. Oncotelic joins an elite group of other key companies focused on advanced biotech platforms that target disease at the genetic or molecular level, including Sarepta Therapeutics Inc. (NASDAQ: SRPT), Alnylam Pharmaceuticals Inc. (NASDAQ: ALNY), Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) and Denali Therapeutics Inc. (NASDAQ: DNLI).The biotechnology sector is evolving from a model centered on long-term R&D investment into one where scientific advancement can be reflected as measurable financial value.As drug candidates advance through clinical development, their value increases significantly due to rising probabilities of success and proximity to commercialization.The rise of fair-value accounting in biotechnology is enabling companies to provide more transparent and timely representations of asset value.Institutional investors are increasingly recognizing clinical-stage biotech assets as investable opportunities, even in the absence of current revenue.Oncotelic Therapeutics operates directly within this convergence, combining oncology-focused drug development with AI-enabled platforms and strategic manufacturing exposure.Click here to view the custom infographic of the Oncotelic Therapeutics editorial.Scientific Progress Is Becoming Financial ValueThe biotechnology sector is evolving from a model centered on long-term R&D investment into one where scientific advancement can be reflected as measurable financial value. Historically, investors relied heavily on discounted cash-flow projections tied to eventual commercialization, often leaving a gap between innovation and valuation. However, the adoption of fair-value frameworks under U.S. GAAP is beginning to bridge that gap by allowing companies to reassess asset value as clinical milestones are achieved.Under Financial Accounting Standards Board guidance, particularly ASC 820, companies can measure the fair value of assets, including illiquid or early-stage investments, based on observable and unobservable inputs. This includes Level 3 assets, which are commonly used in biotech to value pipeline-stage programs and strategic investments. These frameworks allow companies to incorporate scientific progress, regulatory advancement and probability of success into financial reporting.Advisory firms such as Deloitte and PwC note that in life sciences, valuation can reflects forward-looking indicators such as clinical progress and expected commercialization potential, as GAAP fair-value frameworks require assets to be measured based on market participant assumptions about future economic benefits. This approach aligns financial reporting more closely with operational reality, particularly in sectors where revenue may lag innovation by years.This shift is particularly relevant for Oncotelic Therapeutics, which operates in a space where pipeline advancement is a primary driver of value. By aligning its financial reporting with the progression of its therapeutic programs and strategic investments, the company reflects the broader industry movement toward recognizing science itself as an asset.Pipeline Proximity Drives Valuation InflectionAs drug candidates advance through clinical development, their value increases significantly due to rising probabilities of success and proximity to commercialization. This phenomenon — often referred to as valuation inflection — is well documented across the biotech industry. Late-stage assets, particularly those approaching regulatory approval, tend to command a disproportionate share of enterprise value.According to McKinsey & Company, value creation in biopharma is heavily concentrated in late-stage assets, with companies generating the majority of returns as products progress toward approval and commercialization, reflecting reduced risk and clearer revenue visibility. Additional industry analysis shows that assets approaching commercialization drive significant increases in company valuation due to higher probability of success and expected market entry.This dynamic highlights a critical change in how investors assess biotech companies. Rather than focusing solely on current revenue or earnings, market participants increasingly evaluate the maturity and trajectory of pipeline assets. As a result, companies with strong late-stage programs can experience significant valuation increases even before generating commercial sales.For Oncotelic Therapeutics, this trend is particularly relevant, given the company's focus on advancing oncology therapeutics and its strategic positioning within high-value development pathways. As its programs progress and move closer to commercialization, the company's valuation profile reflects the broader industry shift toward pipeline-driven value creation.Fair-Value Accounting Gains Ground in BiotechThe rise of fair-value accounting in biotechnology is enabling companies to provide more transparent and timely representations of asset value. Under GAAP, Level 3 valuations are used to measure assets without observable market prices, relying on models that incorporate forward-looking assumptions such as expected cash flows and probability-weighted outcomes.The ASC 820 framework defines fair value as the exit price that would be received to sell an asset in an orderly transaction between market participants at the measurement date. It provides a structured hierarchy for the subsequent measurement of complex, illiquid assets using market-participant assumptions and the best available information, aligning financial reporting with a current, market-based view of an asset's value.Oncotelic Therapeutics exemplifies this approach through the remeasurement of its stake in GMP Bio, which reflects an approximate $1 billion-plus enterprise value. This demonstrates how clinical and strategic progress can translate directly into balance sheet strength, reinforcing the concept of science as a financial asset.Institutional Capital Embraces Prerevenue BiotechInstitutional investors are increasingly recognizing clinical-stage biotech assets as investable opportunities, even in the absence of current revenue. This shift reflects a growing confidence in structured valuation methodologies that incorporate scientific progress, rather than relying solely on traditional financial metrics.Many biotechnology companies are valued primarily on the strength of their pipelines rather than their existing revenue streams, reflecting the long development timelines and lack of early-stage earnings typical of the sector. Instead, valuation is closely tied to scientific progress, with factors such as clinical development stage, probability of success and regulatory milestones serving as key drivers of equity value. This approach underscores that value creation in biotech often occurs well before commercialization, as investors increasingly rely on milestone-based and probability-adjusted models to assess future potential.Within this context, Oncotelic Therapeutics is positioned to benefit from growing institutional interest in pipeline-driven valuation. Its diversified portfolio and strategic investments align with the types of assets that are increasingly attracting capital in the biotech sector.AI, GMP and Commercial Readiness ConvergeAdvancements in AI-driven drug development and GMP-compliant manufacturing are accelerating timelines and improving scalability across the biotech industry. These technologies enable more efficient clinical development, better data analysis and streamlined production processes, reducing both time and cost to market.AI is increasingly being used to identify drug targets, optimize trial design and analyze complex datasets, improving the probability of success in clinical programs. At the same time, GMP-compliant manufacturing platforms are enabling more reliable and scalable production, which is critical as therapies move toward commercialization.Research indicates that data-driven approaches are becoming central to biopharma value creation, with AI and advanced analytics playing a key role in accelerating development timelines. These advancements enhance the reliability of valuation models by reducing uncertainty and improving execution. This convergence of AI, manufacturing and clinical development is reshaping how value is created and measured in biotech. Companies that can integrate these capabilities are better positioned to advance therapies efficiently while maintaining regulatory compliance.Oncotelic Therapeutics operates directly within this convergence, combining oncology-focused drug development with AI-enabled platforms and strategic manufacturing exposure. This integrated approach supports both scientific advancement and financial valuation, positioning the company within one of the most significant growth trends in the biotechnology sector.The biotechnology sector is entering a new phase in which scientific progress is no longer viewed solely as a cost center but as a measurable financial asset. As fair-value accounting, pipeline maturity and AI-driven development reshape the industry, the traditional gap between innovation and valuation is narrowing.Companies such as Oncotelic Therapeutics illustrate how this transformation is unfolding in real time, demonstrating that clinical advancement can materially strengthen financial positioning even before revenue generation begins. As investors increasingly focus on pipeline-driven value, the ability to translate science into measurable economic impact is becoming one of the defining characteristics of modern biotech.From Research Spend to Revenue-Ready AssetsA new wave of biotechnology innovation is increasingly blurring the line between scientific progress and financial value creation. As drug candidates targeting disease at the genetic and molecular level advance through clinical development in 2026, progress is no longer viewed solely as research expenditure but as a measurable and evolving asset. Recent updates across the sector highlight how advancements in RNA interference, gene therapy and targeted delivery platforms are not only improving clinical outcomes but also enhancing the underlying value of biotech pipelines.Sarepta Therapeutics Inc. (NASDAQ: SRPT) announced approval of its clinical trial application for SRP-1005, its investigational treatment for Huntington's disease. Sarepta expects to initiate this first-in-human clinical trial of SRP-1005 (formerly ARO-HTT) in the second quarter of 2026. SRP-1005 is an investigational small interfering RNA ("siRNA") therapeutic. INSIGHTT is a phase 1, multicenter, dose-escalation study that will evaluate the safety and tolerability of subcutaneous dosing of SRP-1005 in approximately 24 participants.Alnylam Pharmaceuticals Inc. (NASDAQ: ALNY) reported new clinical and real-world data from its cardiovascular ("CV") portfolio. The data was presented at the American College of Cardiology's Annual Scientific Session and Expo ("ACC.26"). The new data continues to support the benefits of vutrisiran in transthyretin amyloid cardiomyopathy (ATTR-CM), as well as the potential of zilebesiran for hypertension, underscoring the versatility of RNAi therapeutics across cardiovascular diseases.Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT) is advancing a suite of messenger RNA ("mRNA")–based therapies. The company's Q4 update highlights progress in both rare diseases and vaccine platforms, including its lead candidate, ARCT-032, an inhaled mRNA therapy for cystic fibrosis, which has demonstrated favorable safety and tolerability and is advancing into a phase 2 clinical study expected to begin in 2026. In addition, the update noted advancement with its ARCT-810 program for ornithine transcarbamylase ("OTC") deficiency, a rare genetic disorder, with ongoing regulatory interactions aimed at supporting future pivotal studies.Denali Therapeutics Inc. (NASDAQ: DNLI) is making significant progress in 2026 with its TransportVehicle(TM) platform. The platform is designed to enable the delivery of biologics across the blood-brain barrier, one of the most persistent challenges in treating neurological diseases. The company has outlined 2026 as a pivotal year, with plans to deliver its first TransportVehicle-enabled medicine to patients and advance two TV-enabled programs into clinical studies for Alzheimer's disease and a program for Pompe disease.These latest developments underscore a broader industry transition from discovery to execution, where scientific innovation is increasingly quantified in financial terms. As genetic and molecular therapies move closer to commercialization, the ability to demonstrate clinical efficacy, scalability and delivery precision is translating into tangible asset value within company pipelines. This convergence of science and finance is reshaping how biotechnology is evaluated, positioning advanced therapeutic platforms not just as research initiatives, but as structured, value-generating assets.For further information about Oncotelic Therapeutics Inc., visit the Oncotelic Therapeutics profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. 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Original: When Science Becomes an Asset: How Advancing Drug Pipelines Are Driving Real-Time Valuation in Biotech

Arcturus Therapeutics Announces Fourth Quarter and Fiscal Year 2025 Financial Results and Pipeline ProgressMarch 3, 2026 4:01 PM
Business Wire
ARCT-032 (CF) Phase 2 third cohort (28 days, 15 mg) generally safe and well tolerated


ARCT-032 permitted to proceed into 12-week Phase 2 study; dosing to begin H1 2026


Cash runway extended into Q2 2028


Investor conference call at 4:30 p.m. ET today


Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics, today announced its financial results for the fourth quarter and fiscal year 2025, and provided corporate updates.


“Arcturus continues to progress its rare disease therapeutic portfolio. We look forward to aligning with regulators on our clinical development strategy for the ornithine transcarbamylase (OTC) deficiency program, and to initiating our Phase 2, 12-week cystic fibrosis (CF) study in the first half of 2026,” said Joseph Payne, President & CEO of Arcturus. “We remain firmly committed to advancing our once-daily inhaled mRNA therapy for people with cystic fibrosis Class I mutations.”


Recent Corporate Highlights



Arcturus’ ARCT-032, a once-daily inhaled mRNA therapeutic candidate for CF, is on track to initiate a new 12-week Phase 2 clinical study in H1 2026 enrolling up to 20 Class I CF participants in the U.S. and abroad. The study will assess safety and early clinical benefits, including potential lung function improvements (ppFEV1, LCI), alongside validated quality-of-life outcomes and high-resolution computed tomography (HRCT) imaging.


Arcturus has completed once-daily dosing of 15 mg of ARCT-032 over 28 days in the third dosing cohort, among four Class I adults with CF, and observed no safety or tolerability issues in this higher dosing cohort.



The safety review committee has reviewed all data from the first three 28-day study cohorts (5, 10, 15 mg) and permitted the program to proceed into the Phase 2, 12-week study.






Arcturus’ ARCT-810 program, an mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency, is broadening its development strategy to address the needs of both adults with late-onset disease and young children affected by the most severe forms of OTC deficiency. The Company is actively engaged in complementary regulatory interactions and strategic planning to support pivotal studies across pediatric and adult populations, including those for whom liver transplantation remains the only current option for survival beyond early childhood. The scheduled Type C regulatory meetings with health authorities, along with the associated feedback, remain on track for the first half of 2026.



In January 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted approval for KOSTAIVE®, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, for use in individuals aged 18 and older.



Arcturus continues to develop a self-amplifying mRNA pandemic influenza (A/H5N1) vaccine under its ongoing contract with BARDA. Recent data from an eight-month follow-up period after the first vaccination indicate that all three tested dose levels (1.5, 5, and 12 mcg) elicit a durable immune response against the vaccine's hemagglutinin and neuraminidase components. The data also supports the sa-mRNA platform's ability to induce meaningful cell-mediated immunity. All tested vaccine doses were well tolerated and did not raise safety concerns.



Arcturus’ lawsuit against AbbVie Inc., and Capstan Therapeutics, Inc.—filed on September 23, 2025, in the U.S. District Court for the Southern District of California—remains ongoing.



Financial Results for the Fourth Quarter and Fiscal Year 2025


Revenue 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 fourth quarter and fiscal year 2025, was $7.2 million and $82.0 million, respectively, representing decreases of $15.6 million and $70.3 million compared to the same periods in 2024. These declines were driven by reductions in revenue from the CSL collaboration, reflecting lower supply agreement activity and a reduced number of development-based milestone achievements as KOSTAIVE® was commercialized.


Operating expenses:


Operating expenses for the fourth quarter and fiscal year 2025 amounted to $38.5 million and $158.3 million, respectively, representing decreases of $17.7 million and $89.7 million compared with the same periods in 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 $24.5 million for the fourth quarter of 2025, compared with $43.8 million for the same period in 2024. The decrease was primarily driven by lower manufacturing costs for the LUNAR-COVID, LUNAR-FLU, and LUNAR-CF programs, as well as reduced clinical trial expenses for LUNAR-COVID and LUNAR-CF. Lower payroll and employee benefits further contributed to the decrease. These reductions were partially offset by higher facilities and equipment costs due to lease impairment in the current period.


Research and development expenses were $112.2 million for fiscal year 2025, compared with $195.2 million for fiscal year 2024. The decrease was primarily driven by lower manufacturing and clinical costs related to the LUNAR-COVID program, reflecting the program’s transition from a development program to the commercial phase. Additional decreases relate to lower manufacturing costs for the LUNAR-CF and LUNAR-FLU programs, as well as lower clinical costs associated with the LUNAR-OTC program. These reductions were partially offset by higher clinical costs for Phase 2 of the LUNAR-CF program. Additional decreases resulted from lower payroll and benefits expenses following the operational restructuring.


General and Administrative Expenses:


General and administrative expenses primarily consist of salaries and related benefits for executive, administrative, legal and accounting functions and professional fees for legal and accounting services. General and administrative expenses for the fourth quarter of 2025 were $14.0 million compared with $12.4 million for the same period in 2024. The increase in fourth quarter expenses relates to the acceleration of employee stock options.


General and administrative expenses for fiscal year 2025 were $46.1 million compared with $52.8 million for fiscal year 2024. The decrease was 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 fourth quarter of 2025, Arcturus reported a net loss of $29.1 million, or ($1.03) per diluted share, compared with a net loss of $30.0 million, or ($1.11) per diluted share for the same period in 2024. For fiscal year 2025, Arcturus reported a net loss of $65.8 million, or ($2.40) per diluted share, compared with a net loss of $80.9 million, or ($3.00) per diluted share for fiscal year 2024.


Cash Position and Balance Sheet:


Cash, cash equivalents and restricted cash were $232.8 million as of December 31, 2025, and $293.9 million as of December 31, 2024. Through disciplined execution and a strategic refocus on existing rare disease clinical programs in fiscal year 2025, Arcturus has extended its cash runway into the second quarter of 2028.


Arcturus Therapeutics Fourth Quarter and Fiscal Year 2025 Earnings Conference Call



Tuesday, March 3, 2026 @4:30 p.m. ET



Domestic: 1-800-274-8461



International: 1-203-518-9814



Conference ID: ARCTURUS



Webcast: Link



Forward Looking Statements


This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, the likelihood of success of the Company’s pipeline (including ARCT-032 and ARCT-810) and partnered programs (including the COVID-19 and flu programs partnered with CSL Seqirus), the likelihood that clinical data, including interim data, will be predictive of future clinical results, the likelihood of and timing for achieving alignment with regulators on the clinical strategy for ARCT-810, plans to broaden the development strategy for ARCT-810, the timing for Type C regulatory meetings for ARCT-810 and feedback therefrom, the likelihood of initiation, and size, scope, and timing, of a Phase 2, 12-week study for ARCT-032, the ongoing development of a self-amplifying mRNA pandemic influenza vaccine under its contract with BARDA, the likelihood that general and administrative expenses will continue to decrease slightly, 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 www.sec.gov. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.


About Arcturus


Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration with CSL Seqirus, U.S. BARDA for pandemic flu and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA (siRNA), circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 500 patents and patent applications in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com. Please connect with us on X and LinkedIn.




ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES




CONSOLIDATED BALANCE SHEETS








 






 






 








 






 






As of December 31,








(in thousands, except per share data)






 






2025






 






2024








Assets






 






 






 






 








Current assets:






 






 






 






 








Cash and cash equivalents






 






$






230,909






 






 






$






237,028






 








Restricted cash






 






 






—






 






 






 






55,000






 








Accounts receivable






 






 






5,564






 






 






 






3,974






 








Prepaid expenses and other current assets






 






 






4,973






 






 






 






9,977






 








Total current assets






 






 






241,446






 






 






 






305,979






 








Property and equipment, net






 






 






6,736






 






 






 






9,531






 








Operating lease right-of-use asset






 






 






21,081






 






 






 






26,674






 








Non-current restricted cash






 






 






1,885






 






 






 






1,885






 








Total assets






 






$






271,148






 






 






$






344,069






 








Liabilities and Stockholders’ Equity






 






 






 






 








Current liabilities:






 






 






 






 








Accounts payable






 






$






4,235






 






 






$






7,194






 








Accrued liabilities






 






 






23,898






 






 






 






38,781






 








Deferred revenue






 






 






8,246






 






 






 






19,514






 








Total current liabilities






 






 






36,379






 






 






 






65,489






 








Deferred revenue, net of current portion






 






 






—






 






 






 






12,604






 








Operating lease liability, net of current portion






 






 






20,784






 






 






 






24,998






 








Total liabilities






 






 






57,163






 






 






 






103,091






 








Stockholders’ equity:






 






 






 






 








Common stock: $0.001 par value; 60,000 shares authorized; issued and outstanding shares were 28,414 at December 31, 2025 and 27,000 at December 31, 2024






 






 






28






 






 






 






27






 








Additional paid-in capital






 






 






728,547






 






 






 






689,758






 








Accumulated deficit






 






 






(514,590






)






 






 






(448,807






)








Total stockholders’ equity






 






 






213,985






 






 






 






240,978






 








Total liabilities and stockholders’ equity






 






$






271,148






 






 






$






344,069






 







 




ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES




CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS








 






 






 








 






 






Year Ended December 31,








(in thousands, except per share data)






 






2025






 






2024






 






2023








Revenue:






 






 






 






 






 






 








Collaboration revenue






 






$






67,221






 






 






$






138,389






 






 






$






157,748






 








Grant revenue






 






 






14,810






 






 






 






13,921






 






 






 






9,051






 








Total revenue






 






 






82,031






 






 






 






152,310






 






 






 






166,799






 








Operating expenses:






 






 






 






 






 






 








Research and development, net






 






 






112,212






 






 






 






195,156






 






 






 






192,133






 








General and administrative






 






 






46,079






 






 






 






52,823






 






 






 






52,871






 








Total operating expenses






 






 






158,291






 






 






 






247,979






 






 






 






245,004






 








Loss from operations






 






 






(76,260






)






 






 






(95,669






)






 






 






(78,205






)








Gain (loss) from foreign currency






 






 






382






 






 






 






(471






)






 






 






(229






)








Finance income, net






 






 






10,095






 






 






 






15,195






 






 






 






16,591






 








Gain on debt extinguishment






 






 






—






 






 






 






—






 






 






 






33,953






 








Net loss before income taxes






 






 






(65,783






)






 






 






(80,945






)






 






 






(27,890






)








(Benefit) provision for income taxes






 






 






—






 






 






 






(4






)






 






 






1,835






 








Net loss






 






 






(65,783






)






 






 






(80,941






)






 






 






(29,725






)








Net loss per share, basic and diluted






 






$






(2.40






)






 






$






(3.00






)






 






$






(1.12






)








Weighted-average shares outstanding, basic and diluted






 






 






27,386






 






 






 






27,000






 






 






 






26,628






 








Comprehensive loss






 






$






(65,783






)






 






$






(80,941






)






 






$






(29,725






)







 




ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES




CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)








 






 






 








 






 






Three Months Ended








 






 






December 31,








(in thousands, except per share data)






 






2025






 






2024








Revenue:






 






 






 






 








Collaboration revenue






 






$






3,081






 






 






$






21,000






 








Grant revenue






 






 






4,115






 






 






 






1,766






 








Total revenue






 






 






7,196






 






 






 






22,766






 








Operating expenses:






 






 






 






 








Research and development, net






 






 






24,476






 






 






 






43,780






 








General and administrative






 






 






14,027






 






 






 






12,380






 








Total operating expenses






 






 






38,503






 






 






 






56,160






 








Loss from operations






 






 






(31,307






)






 






 






(33,394






)








Gain from foreign currency






 






 






701






 






 






 






171






 








Finance income, net






 






 






1,523






 






 






 






3,214






 








Net loss before income taxes






 






 






(29,083






)






 






 






(30,009






)








Benefit for income taxes






 






 






(4






)






 






 






(4






)








Net loss






 






$






(29,079






)






 






$






(30,005






)








Net loss per share, basic and diluted






 






$






(1.03






)






 






$






(1.11






)








Weighted-average shares outstanding, basic and diluted






 






 






28,112






 






 






 






27,000






 








Comprehensive loss






 






$






(29,079






)






 






$






(30,005






)







 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260303197744/en/
Arcturus Therapeutics

Public Relations & Investor Relations

Neda Safarzadeh

VP, Head of IR/PR/Marketing

(858) 900-2682

IR@ArcturusRx.com


Original: Arcturus Therapeutics Announces Fourth Quarter and Fiscal Year 2025 Financial Results and Pipeline Progress

Arcturus Therapeutics to Report Fourth Quarter and Fiscal Year 2025 Financial Results and Provide Corporate Update on March 3, 2026February 17, 2026 4:01 PM
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 that it will release its financial results for the quarter and year ended December 31, 2025 after the market close on Tuesday, March 3 and will also host a conference call and webcast at 4:30 p.m. Eastern Time on March 3, 2026.


Arcturus Therapeutics Fourth Quarter and Fiscal Year 2025 Earnings Conference Call



Tuesday, March 3, 2026, at 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 with CSL Seqirus, U.S. BARDA for pandemic flu and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA (siRNA), circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 500 patents and patent applications in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com. Please connect with us on X and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260217553714/en/
Arcturus Therapeutics

Public Relations & Investor Relations

Neda Safarzadeh

VP, Head of IR/PR/Marketing

(858) 900-2682

IR@ArcturusRx.com


Original: Arcturus Therapeutics to Report Fourth Quarter and Fiscal Year 2025 Financial Results and Provide Corporate Update on March 3, 2026

Groundbreaking Slovakian Analysis Finds More DNA Than mRNA Disproving Covid Shot Can Be Called an "mRNA Vax"‼️

Slovak physician Dr. Peter Kotlár had announced that the mRNA vax are officially GMO and now has reported that Slovakia is one of the only countries in the world, if… pic.twitter.com/FCYSj6q8xG— Sophia Dahl (@sophiadahl1) April 29, 2025 $ARCT

ARCT a buy again

That awful Cathie Wood has been a recent buyer

ARCT 10Q due AUGUST5

ARCT 10Q due March 7

ARCT new 52 week high

Arcturus Therapeutics (ARCT)
icon-fall
19%
Shares of Arcturus Therapeutics traded down ~19% on Tuesday after the company announced4 lower-than-expected revenue and earnings for the second quarter. According to management, revenue declined in response to the termination of two agreements, one with Vinbiocare and another with the Israeli Ministry of Health. Arcturus Therapeutics develops mRNA-based vaccines and therapeutics for the treatment of infectious and rare genetic diseases.

Arcturus Therapeutics Holdings Inc NASDAQ: ARCT

GoSymbol lookup
Health Care : Biotechnology | Small Cap GrowthCompany profile
Arcturus Therapeutics Holdings Inc. is a global late-stage clinical messenger RNA medicines and vaccine company. The Company is focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases. In addition to its messenger RNA (mRNA) platform, its lipid nanoparticle (LNP) delivery system, LUNAR, has the potential to enable multiple nucleic acid medicines, and its self-amplifying mRNA technology (Self-Transcribing and Replicating RNA (STARR), technology) has the potential to provide longer-lasting RNA and sustained protein expression at lower dose level. It is leveraging its LUNAR platform







and its nucleic acid technologies to develop and advance a pipeline of mRNA-based vaccines and therapeutics for infectious diseases and rare genetic disorders with significant unmet medical needs. Its COVID-19 vaccine candidate, which is based on its STARR technology platform is through Phase II clinical trials.
Arcturus Therapeutics (ARCT)
icon-rise-1
15%
Shares of Arcturus Therapeutics traded up ~15% on Friday after the company’s vaccine, ARCT-154, demonstrated6 an improvement in immunogenicity—43% more neutralizing antibodies at a lower dose than Comirnaty®. Arcturus Therapeutics develops mRNA-based vaccines and therapeutics for the treatment of infectious and rare genetic diseases.

Arcturus Therapeutics (ARCT)
icon-rise-1
15%
Shares of Arcturus Therapeutics traded up ~15% on Friday after the company’s vaccine, ARCT-154, demonstrated6 an improvement in immunogenicity—43% more neutralizing antibodies at a lower dose than Comirnaty®. Arcturus Therapeutics develops mRNA-based vaccines and therapeutics for the treatment of infectious and rare genetic diseases.
Arcturus Therapeutics (ARCT)
icon-rise-1
15%
Shares of Arcturus Therapeutics traded up ~15% on Friday after the company’s vaccine, ARCT-154, demonstrated6 an improvement in immunogenicity—43% more neutralizing antibodies at a lower dose than Comirnaty®. Arcturus Therapeutics develops mRNA-based vaccines and therapeutics for the treatment of infectious and rare genetic diseases.

Silence is golden ARC

Wow big after hours green buy

Spike delivers in Canada 400 million does

http://archive.fast-edgar.com/20210812/A2Z2M22C3Z2232K222JN2CZ272FUV22SE232/ another company that directs them selling out potentially seems like a big negative along with many downgrades over $20.00 less than current PPS

I don’t see any filing that reflects that. Where do you see it?

Director sold 725,000 shares @ $55.44 and 25,000 @ $45.83 total of 800,000 shares

Capitalization at it's finest, run for the hills. imho

bounce off 30's then into 20's

B. Wriley Price target $27.00. Price Per Share PPS is $47.00. Only $20.00 to drop to hit raised price target.

$1.40* opps

1-7 R/S

Sold drug in a few years will prob do another one sadly

Don't forget was like $1.10 at one point. Only 2 mil Revenue VS 2.7 expected.. while losing 56.4 mil in the second quarter or over 225,000,000 million loss for the year.

-$225,000,000 vs maybe 4 mil on a good year

Downgraded to under preform

Sold the drug now have nada

Also had nice size R/S in the past

Posted Revenue of $2 million vs estimated 2.7 mil.

Loss of $56.4 million second quarter only.

Huge differences

Sold the drug... No mo

Down graded to underperform

Notification That Quarterly Report Will Be Submitted Late (nt 10-q)

Oh no...

ARCT the next NVAX.

might be getting squeezed, the float is so low.

wow this is pumping

Thoughts now?

Still long here. This is a looong term buy. Disappointing that we got that massive haircut, but we've had them before and recovered. It's the nature of this volatile sector.

Well?

In TDAmeritrade. TIPRANKS 7 SCROE PT: $88.25
Analyst Ratings, Moderate Buy! Last actualitation!
Based on the 10 sell-sidetooltipClick this button to read the definition of sell-side analysts who offered a 12-month price target in the last three months. Analysts predict a(n) 122.80% increase from today.
Kumaraguru Raja
Brookline Capital Markets
5Stars target $102.00rankingBuyanalystAction
Maintained date 2 days ago
analyst
Steven Seedhouse
Raymond James
5 Stars target ranking Hold analystAction Downgraded date 2 days ago
analyst
Yasmeen Rahimi
Piper Sandler
5Star target $140.00 ranking Buy analystAction Maintained
date 2 days ago
analyst
Seamus Fernandez
Guggenheim
5 Stars target -- ranking Buy analystAction Maintained date
2 days ago
Madhu Kumar
Robert W. Baird
5 Stars target $69.00 ranking Hold analystAction Downgraded
date
2 days ago
analyst
Elemer Piros
Roth Capital
5 Stars target $77.00 ranking Sell analystAction Maintained
date 2 days ago
Mayank Mamtani
B.Riley Financial
5 Stars target $138.00 ranking Buy analystAction Maintained
date 2 days ago
analyst
Yigal Nochomovitz
Citigroup
5Stars target $133.00 ranking Buy analystAction Maintained
date 17 days ago

Nope- was just a good “tax dump day” excuse today. Not holding- but really tempted- can only see upwards from here. Cathy woods didn’t sell a share today. Tells you something..

ARCT - Re-enter in the 30's. 34-37 seems to be my gate with this one.


The ol' "buy the rumor, sell the news" strikes again.


Or, today is last day to sell for 2020 taxes -- Dump day.


Take your pick.


It's a pandemic market and more crazy and unexpected things to come.


Remember, ARCT has a lot more to offer than just COVID solutions.


Their tech enables many other biotech companies delivery and replication methods.


ARCT has established a 52-wk high of $130.


Many think it will go past that.

* * $ARCT Video Chart 12-29-2020 * *

Link to Video - click here to watch the technical chart video

Wish I had flipped it. Hindsight is 20/20.

ARCT - Me as well. Been in-n-out four times with profits every time.


When I talk to others they never heard of ARCT.


Ready for the next leg.

I'm still in - going to see where the ride takes me

ARCT - Still going but nobody on iHub seems aware.


Some on Stocktwits saying this is going to $500-700.


I get 10x plays often, but this is a big 10x for sure.

JUST IN: $ARCT Why Arcturus Therapeutics Stock Soared Today

Shares of Arcturus Therapeutics Holdings (NASDAQ: ARCT) were soaring 12.7% higher as of 3:28 p.m. EST on Tuesday. The big jump came after the clinical-stage biotech provided its third-quarter update following the market close on Monday. Investors were less interested in Arcturus' fi...

In case you are interested ARCT - Why Arcturus Therapeutics Stock Soared Today

Breaking News: $ARCT Arcturus Therapeutics Announces Completion of First Three Dose Escalation Cohorts in Phase 1 Study of ARCT-810, Therapeutic Candidate for Ornithine Transcarbamylase (OTC) Deficiency

LUNAR® lipids undetectable in plasma 48 hours following drug administration ARCT-810 well tolerated at doses up to 0.3 mg/kg, 0.4 mg/kg cohort to be completed in Q4 Initial dosing of OTC-deficient patients at a U.S. clinical site expected in Q4 Arcturus ...

Find out more ARCT - Arcturus Therapeutics Announces Completion of First Three Dose Escalation Cohorts in Phase 1 Study of ARCT-810, Therapeutic Candidate for Ornithine Transcarbamylase (OTC) Deficiency

I'm more amazed that anyone posted on this board. But I agree on the breakout!

ARCT - In it to win it.

Breakout! Blue skies.

Wow! Someone posted on the ARCT board. Thank you very much. I like your chart. I will put my faith in Fibonacci!

$ARCT | #ArcturusTherapeutics Breakout Alert



Potential long above $63.00
Upside Fibonacci target zone $76.00

Hello silent ARCT board. Just a message to say I am still here! Still long ARCT.

That's what I thought. Thank you.

$ARCT - Doesn't look like the two are comparable.

$ARCT's self replicating delivery method along with the protein they are developing to block the keyholes in the host (humans) the spikes on viruses need to infect the host is a unique approach. Can't spike into a receiving host keyhole, no infection or replication. Game over.

$ARCT would be one shot as a cure for nearly all viruses, including the common flu.

I'm also a little weary with all these biotechs promising cures so soon.

Rhinovirus(Flu/common cold) still has no vaccine which they have been working to cure since the 1950's.

$ARCT thinks they have the total solution.

Hey do you know anywhere with a good competitive analysis of ARCT vs. the Oxford University vaccine?

It's truly incredible. I'm thrilled to be here.