Arcturus Therapeutics Holdings Inc. (ARCT): Business Model Canvas [Apr-2026 Updated]

Honestly, looking at Arcturus Therapeutics Holdings Inc. right now feels like watching a strategic pivot in real-time: they are defintely leaning hard into their wholly-owned rare disease assets, ARCT-032 and ARCT-810, which demands serious capital, especially since operating expenses hit $119.8 million for the first nine months of 2025. You need to see the structure behind this high-stakes play, which is currently funded by a $237.3 million cash position as of September 30, 2025, even as collaboration revenue-which totaled $74.8 million year-to-date-is naturally changing shape. This Business Model Canvas cuts right through the noise to show you the key resources, like the LUNAR and STARR platforms, that must deliver to extend that cash runway well into 2028; check out the details below to map the risks and opportunities.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Key Partnerships

You're looking at the core alliances that fuel Arcturus Therapeutics Holdings Inc.'s engine, especially as they transition from pure development to commercialization milestones. These partnerships are critical for both funding R&D and getting their novel mRNA technology into the market.

The revenue Arcturus Therapeutics Holdings Inc. pulls in from these strategic alliances and collaborations forms a primary income source, alongside license fees and consulting fees. For the three months ended September 30, 2025, revenue from these arrangements was part of the total $17.2 million reported revenue. This figure represented a decrease of $24.5 million compared to the same period in 2024, which the company noted was primarily driven by lower supply agreement revenue from the CSL collaboration as KOSTAIVE transitioned. Still, the cash runway remains extended into 2028 due to planned cost reductions and program re-allocations.

The nature of these relationships is complex, involving technology licensing, manufacturing support, and co-development rights across infectious disease and rare disease pipelines.

CSL Seqirus for global mRNA vaccine development and commercialization

The global collaboration and license agreement with CSL Seqirus is foundational for Arcturus Therapeutics Holdings Inc.'s vaccine ambitions, granting CSL Seqirus exclusive license to Arcturus Therapeutics Holdings Inc.'s STARR self-amplifying mRNA (sa-mRNA) technology for influenza, COVID-19, and other respiratory viral diseases.

The financial structure of this deal is substantial, though the upfront cash has already been booked. Arcturus Therapeutics Holdings Inc. received an upfront payment of US$200 million. Beyond that, the company is eligible for significant future payments:

• Eligible for over $1.3 billion in development milestone payments.
• Eligible for over $3 billion in commercial milestones.
• Eligible for a 40% net profit share for COVID-19 vaccine products.
• Eligible for up to double-digit royalties for other potential products like flu vaccines.

Operationally, the partnership saw the clinical study report for ARCT-2138, an sa-mRNA seasonal influenza vaccine candidate, finalized in June 2025. Furthermore, Arcturus Therapeutics Holdings Inc. received the initial European Union (EU) approval milestone payment from CSL Seqirus in the first quarter of 2025 related to the approval of KOSTAIVE®.

ARCALIS joint venture in Japan for mRNA manufacturing and supply

ARCALIS Co., Ltd. serves as Arcturus Therapeutics Holdings Inc.'s manufacturing joint venture in Japan, focused on supporting the production of mRNA vaccines and therapeutics. Arcturus Therapeutics Holdings Inc. maintains a 49% equity position in ARCALIS, which is subject to dilution.

This entity has secured significant non-dilutive funding from the Japanese government to build out its capacity. To date, ARCALIS has been awarded a total of $165 million in grants from the Japanese government to construct facilities and acquire equipment for Current Good Manufacturing Practice (cGMP) production of mRNA drug substance and drug product.

The manufacturing footprint advanced significantly in late 2024 and early 2025. Meiji Seika Pharma, a local partner, invested in ARCALIS in November 2024. Then, in January 2025, the joint venture, along with Meiji Seika Pharma, received Ministry of Health, Labour and Welfare (MHLW) approval to add commercial manufacturing sites in Japan for KOSTAIVE®.

Government agencies like BARDA for pandemic influenza vaccine funding

The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), is a key financial backer for Arcturus Therapeutics Holdings Inc.'s pandemic preparedness work. This support is formalized under contract number 75A50122C00007.

Specifically, BARDA is fully funding the development of the LUNAR-H5N1 (ARCT-2304) vaccine candidate, with a contract valued at up to $63 million. The Phase 1 trial, which began dosing in December 2024, is designed to enroll approximately 200 healthy adults. As of March 2025, Arcturus Therapeutics Holdings Inc. was confident of retaining this funding, with interim Phase 1 data anticipated in the second half of 2025.

Academic and clinical research organizations for trial execution

Execution of clinical trials relies on established relationships with academic centers and clinical research organizations. For instance, the ongoing Phase 2 study of ARCT-032 for cystic fibrosis (CF) involves daily inhaled treatments over a 28-day period in adult participants. The Perelman School of Medicine, University of Pennsylvania, is associated with this program.

The Phase 2 study for ARCT-810, targeting ornithine transcarbamylase (OTC) deficiency, involves a regimen of five intravenous infusions administered over a two-month period.

Here is a quick look at the structure and financial components of the primary external relationships:

The CSL Seqirus collaboration revenue decline in Q3 2025 to $17.2 million total revenue shows the lumpiness inherent in milestone-driven partnerships, but the underlying technology licensing remains active.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Key Activities

You're hiring before product-market fit, so focusing on the core engine-the Key Activities-is how you manage cash burn and hit those critical value inflection points. Here's the breakdown for Arcturus Therapeutics Holdings Inc. (ARCT) as of late 2025, grounded in their Q3 2025 financial reporting.

Research and development (R&D) of wholly-owned rare disease therapeutics is a primary driver, though the associated expenses show a reduction as certain vaccine development phases concluded. For the nine months ended September 30, 2025, Research and development expenses totaled $87.7 million, down from $151.4 million for the same period in 2024. This reduction was mainly due to lower manufacturing and clinical costs related to the LUNAR-COVID and LUNAR-FLU programs, partially offset by higher clinical costs for the Phase 2 of the LUNAR-CF program.

The financial commitment to R&D in the third quarter alone was $23.3 million, compared to $39.1 million in the third quarter of 2024. Honestly, managing this spend is key, especially since the net loss for the nine months ended September 30, 2025, was approximately $36.7 million.

The core of this activity is captured in the following financial snapshot:

Advancing the pipeline means executing on specific clinical milestones for their rare disease candidates.

• ARCT-032 (CF): Interim Phase 2 clinical activity findings were shared with the CF community last month at NACFC. The company plans to start a 12-week safety and preliminary efficacy study in up to 20 CF participants in the first half of 2026. Enrollment for the adult Phase 2 study was expected to complete by year-end 2025.
• ARCT-810 (OTC deficiency): The team is working to achieve alignment with regulatory agencies on pivotal study designs. Phase 3 biomarker and trial design alignment with regulators is anticipated in the first half of 2026. Positive interim Phase 2 data suggested improvement of urea cycle function.

Maintaining and expanding the LUNAR and STARR proprietary technology platforms is foundational, as these are the delivery and self-amplifying mechanisms underpinning the pipeline. The STARR Technology platform combines self-replicating RNA with LUNAR, the nanoparticle delivery system, into one solution. Arcturus Therapeutics Holdings Inc. covers these technologies with an extensive patent portfolio of over 500 patents and patent applications globally.

Commercial supply and regulatory filings for partnered vaccines, specifically KOSTAIVE®, represent a transition from development payments to commercial revenue streams. This transition has impacted recent revenue figures, as seen by the revenue decline from the CSL collaboration.

Key updates on the partnered vaccine activity include:

• Meiji Seika Pharma launched the two-dose vial of KOSTAIVE updated for the JN.1 variant in Japan in August 2025.
• Meiji received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in August 2025.
• The European Commission approved KOSTAIVE® in February 2025, unlocking a market of 30 countries.
• The U.S. Biologics License Application (BLA) filing to the FDA remained on track for Q3 2025, with an approval decision expected in 2026.

Finance: draft 13-week cash view by Friday.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Key Resources

When you look at Arcturus Therapeutics Holdings Inc.'s foundation, the key resources aren't just about the balance sheet; they are deeply rooted in their proprietary science. These are the assets that underpin every potential future revenue stream, so it's important to see the hard numbers supporting them as of late 2025.

The company's financial footing, while showing a net loss for the nine months ended September 30, 2025, still provides a significant operational buffer. You can see the current liquidity position here:

Honestly, that cash position, extended into 2028, gives the management team the necessary time to focus on their core therapeutic pipeline without immediate financing pressure. That's a critical resource right now.

The true, non-fungible assets, however, are the enabling technologies that allow Arcturus Therapeutics Holdings Inc. to create their pipeline candidates. These platforms are what they sell, license, and build their future on:

• Proprietary LUNAR lipid-mediated delivery system. This is how they get their fragile mRNA cargo into the right cells, which is half the battle in this field.
• STARR self-amplifying mRNA technology platform (sa-mRNA). This platform is designed to allow the body's own cells to produce more of the therapeutic protein from a smaller initial dose.

These platforms are versatile, too. Arcturus Therapeutics Holdings Inc. can apply them across multiple modalities, not just the self-amplifying mRNA vaccines like KOSTAIVE®. Think about the breadth:

• Messenger RNA (mRNA)
• Small interfering RNA (siRNA)
• Circular RNA
• Antisense RNA
• Self-amplifying RNA (sa-mRNA)
• DNA and gene editing therapeutics

The intellectual property portfolio backs all of this up. Having over 500 patents and applications across key global markets like the U.S., Europe, and Japan means they have built significant barriers to entry around their core science. That IP is the moat protecting the value of the LUNAR and STARR platforms.

If you're looking at the tangible assets that drive near-term value, consider the progress on their two main clinical assets, which are direct outputs of these key resources. For instance, the interim Phase 2 data for ARCT-032 in cystic fibrosis showed encouraging mucus plug reduction after 28 days of treatment in Class I CF participants. That data is a direct conversion of their LUNAR and STARR tech into clinical evidence. Finance: draft 13-week cash view by Friday.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Value Propositions

Potential for lower dose requirements and superior immune response via STARR sa-mRNA.

The self-replicating RNA-based prophylactic vaccine technology is expected to provide lower dose requirements due to superior immune response and sustained protein expression when compared to non-self-replicating RNA-based vaccines. You can see this potential in the data from the ARCT-2304 program for Pandemic Influenza A Virus H5N1, where single doses at 1.5 µg, 5 µg, and 12 µg induced a humoral immune response similar to or higher than the MF59-adjuvanted pandemic vaccine.

The durability of the immune response is also a key value point. Head-to-head data for the ARCT-154 vaccine demonstrated that the self-amplifying mRNA (sa-mRNA) maintained superior immunogenicity compared to the conventional mRNA vaccine Comirnaty® for up to 12 months post-vaccination, and this was achieved at one-sixth the dose (5 µg vs 30 µg, respectively).

Effective and safe delivery of RNA therapeutics to target tissues using LUNAR.

The LUNAR® lipid-mediated delivery system is a multi-component drug delivery system built upon a library of over 250 proprietary lipids. This allows for customization of formulations for the indication and target cell type of interest. For the cystic fibrosis (CF) program, ARCT-032, which uses the inhaled LUNAR platform, showed encouraging interim Phase 2 data, with participants receiving 10 mg doses daily over 28 days showing a trend towards mucus plug reduction.

For the OTC deficiency program, ARCT-810, which also utilizes LUNAR delivery, demonstrated that the technology was generally safe and well tolerated in Phase 2 studies, with interim results showing stable ammonia levels in all patients during treatment.

Addressing high unmet medical needs in rare diseases (CF, OTC deficiency).

Arcturus Therapeutics Holdings Inc. is focusing its resources on developing therapeutics for rare diseases where the need is significant. For CF, ARCT-032 is intended for people who do not qualify for or benefit from available treatment options. For OTC deficiency, ARCT-810 is designed to address the underlying cause by enabling liver cells to produce the OTC enzyme, offering a solution where there are currently limited options for symptomatic patients.

The company is planning to initiate a 12-week safety and preliminary efficacy study in up to 20 CF participants in the first half of 2026. For OTC deficiency, alignment with regulatory agencies around pivotal trial strategy for both pediatric and adult populations is planned for the first half of 2026.

Customizable platform for diverse nucleic acid medicines (mRNA, siRNA, etc.).

The underlying technology is highly versatile, which is a major value driver for future pipeline expansion. The company's technologies are covered by an extensive patent portfolio consisting of over 500 patents and patent applications across the U.S., Europe, Japan, China, and other countries. This platform supports a broad range of modalities.

Here's a look at the diverse nucleic acid medicines the platform can be applied toward:

• Messenger RNA (mRNA)
• Small Interfering RNA (siRNA)
• Circular RNA
• Antisense RNA
• Self-Amplifying RNA (sa-mRNA)
• DNA
• Gene Editing Therapeutics

The financial health supports this platform development; Arcturus Therapeutics Holdings Inc. reported cash, cash equivalents and restricted cash of approximately $273.8 million as of March 31, 2025, with the cash runway expected to extend into 2028 following resource re-allocation.

The breadth of the platform is summarized below:

The company reported a net loss of approximately $13.5 million for the three months ended September 30, 2025.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Customer Relationships

You're looking at how Arcturus Therapeutics Holdings Inc. manages its key relationships, which heavily rely on high-value, strategic external parties rather than a broad consumer base. This is all about deep, focused engagement with partners, regulators, and the investment community.

High-touch, long-term strategic alliances with major pharmaceutical partners.

Arcturus Therapeutics Holdings Inc. structures its most critical relationships around collaborations, which form a primary source of its funding and commercial reach. These alliances generate revenue through license fees, consulting fees, technology transfer fees, reservation fees, and collaborative payments from pharmaceutical and biotechnology partners. For the three months ended September 30, 2025, total revenue was reported at $17.2 million, a decrease of $24.5 million compared to the same period in 2024. The decrease in revenue reflects lower milestone revenues recognized under the CSL collaboration agreement as KOSTAIVE transitions from a development program to the commercial phase. The KOSTAIVE COVID-19 vaccine has launched in Japan. The company is focused on continuing support from CSL to commercialize KOSTAIVE in Asia and Europe.

Direct engagement with key opinion leaders, physicians, and patient advocacy groups.

Direct engagement is vital for validating clinical progress in rare disease areas. Arcturus Therapeutics Holdings Inc. actively presents data to these groups to reinforce commitment to its pipeline candidates. For instance, the company hosted a virtual Key Opinion Leader (KOL) presentation of ARCT-810 Phase 2 interim data for Ornithine Transcarbamylase (OTC) deficiency on Monday, June 30, 2025, at 12:00 p.m. ET. This presentation featured KOLs like Marshall Summar, MD, an expert in urea cycle disorders. Also, conversations at the NACFC (North American Cystic Fibrosis Conference) with CF patients, physicians, investigators, and global experts reinforced the commitment to advance ARCT-032 further into development.

The company's pipeline focus includes:

• ARCT-810 for OTC deficiency, showing improved urea cycle function.
• ARCT-032 for cystic fibrosis (CF), with interim Phase 2 data presented in September 2025.

Intensive regulatory alignment efforts for pivotal trial designs (e.g., ARCT-810 Phase 3).

Achieving alignment with regulatory bodies dictates the path to market for its core therapeutics. Planned alignment with regulatory agencies around the pivotal trial strategy for ARCT-810 for OTC deficiency, covering both pediatric and adult populations, remains on track for the first half of 2026. Similarly, discussions with the FDA and other regulatory agencies for the ARCT-032 (CF) program regarding Phase 3 design are anticipated in the first half of 2026. The ARCT-2304 pandemic influenza vaccine candidate received U.S. FDA Fast Track Designation in April 2025.

Key regulatory milestones planned for 2026 include:

• Phase 3 trial design alignment for ARCT-810 with the FDA and other agencies.
• Discussions for Phase III initiation for ARCT-032.

Dedicated investor relations for transparent communication on clinical catalysts.

Arcturus Therapeutics Holdings Inc. maintains a regular cadence of communication with the investment community to discuss clinical catalysts and financial health. The company hosted its Third Quarter 2025 Earnings Call on Monday, November 10, 2025, at 4:30 p.m. ET. Prior to that, the Second Quarter 2025 Earnings Call took place on August 11, 2025, also at 4:30 p.m. ET. The company was active in investor outreach, participating in events like the Guggenheim Second Annual Healthcare Innovation Conference on November 12, 2025. The investor base shows significant institutional interest, with institutional ownership reported at 95.32%, while insider ownership stands at 8.17%. The analyst target price is set at $32.88. The company has extended its cash runway into 2028 following planned cost reductions.

Investor Relations Contact Information (as of Q1 2025):

• VP, Head of IR/PR/Marketing: Neda Safarzadeh.
• Email: IR@ArcturusRx.com.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Channels

You're looking at how Arcturus Therapeutics Holdings Inc. gets its products and value propositions to its customers and partners as of late 2025. This involves a mix of established global partners, dedicated regional manufacturing, and the clinical trial network that serves as the initial access point for its therapeutic candidates.

Global commercial infrastructure of CSL Seqirus for vaccine distribution

Arcturus Therapeutics Holdings Inc. relies on its ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus for vaccine distribution channels. This partnership covers programs for SARS-CoV-2 (COVID-19), specifically the KOSTAIVE vaccine, and influenza. The transition of the COVID program to the commercial phase is impacting operational expenses, with a reported decrease in general and administrative expenses expected due to this transition. Regulatory milestones tied to this channel included an MAA (Marketing Authorization Application) filing in the United Kingdom anticipated in Q2 2025 for KOSTAIVE.

The financial output from these strategic alliances, which includes payments from the CSL Seqirus collaboration, is a primary revenue component for Arcturus Therapeutics Holdings Inc.

ARCALIS manufacturing and supply chain for Japanese market access

For the Japanese market, Arcturus Therapeutics Holdings Inc. utilizes its joint venture in Japan, ARCALIS, which is focused on the manufacture of mRNA vaccines and therapeutics. This entity is a key part of the supply chain, especially following the submission of a partial change application by Meiji Seika Pharma to include Japanese manufacturing sites, such as ARCALIS, Inc., for KOSTAIVE® approval. Furthermore, Arcturus Therapeutics Holdings Inc. is planning to transfer its cystic fibrosis manufacturing process technology to ARCALIS.

Direct out-licensing and technology transfer to biotech/pharma partners

The channel for direct engagement with partners involves revenue generated from license fees, consulting fees, technology transfer fees, and collaborative payments from research and development arrangements. This represents the direct monetization of Arcturus Therapeutics Holdings Inc.'s enabling technologies, such as LUNAR® lipid-mediated delivery and STARR® mRNA technology (sa-mRNA). The company's extensive patent portfolio, covering over 500 patents and patent applications across the U.S., Europe, Japan, and China, underpins these technology transfer channels.

Clinical trial sites and specialized treatment centers for therapeutic candidates

Clinical trial sites and specialized treatment centers serve as the initial channel for accessing patients for the therapeutic candidates, ARCT-032 for cystic fibrosis (CF) and ARCT-810 for OTC deficiency.

• ARCT-032 Phase 2 study (NCT06747858) is advancing, with interim data expected in September 2025 from the first 9 enrolled participants.
• Enrollment for the ARCT-032 study is expected to complete by year-end 2025.
• A follow-up 12-week study for ARCT-032 is planned to begin in the first half of 2026, enrolling up to 20 CF participants.
• For ARCT-810, a prior placebo-controlled European study completed dosing in 8 OTC deficient individuals (0.3 mg/kg cohort).
• A separate Phase 1 vaccine trial (NCT06602531) completed recruitment of 212 adults across multiple sites in the U.S..

Meetings with the FDA and other regulatory agencies to discuss pivotal trials and Phase III initiation for these therapeutics are anticipated in the first half of 2026.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Customer Segments

You're looking at the core groups Arcturus Therapeutics Holdings Inc. serves as of late 2025, focusing on both their rare disease pipeline and their established vaccine partnerships. It's a mix of specialized patient groups and large institutional buyers.

Patients with Ornithine Transcarbamylase (OTC) deficiency

• Target population in Europe and the U.S. is approximately 10,000 people.
• Treatment candidate ARCT-810 aims to express functional OTC enzyme in the liver.
• Phase 2 data review in June 2025 showed ARCT-810 significantly and consistently reduced biomarker glutamine to levels within the normal range.
• Pivotal trial strategy alignment with regulatory agencies is planned for the first half of 2026.

Cystic Fibrosis (CF) patients intolerant to or non-responsive to current CFTR modulators

• ARCT-032 is the inhaled mRNA therapeutic candidate for CF.
• Interim Phase 2 data in October 2025 showed observed mucus plug reduction after 28 days of treatment in Class I CF adults.
• A 12-week safety and preliminary efficacy study in up to 20 CF participants is planned to start in the first half of 2026.

Global pharmaceutical and biotechnology companies seeking advanced mRNA platforms

This segment is primarily engaged through strategic alliances and collaborations, which form a key part of Arcturus Therapeutics Holdings Inc.'s revenue base, though these streams have seen recent fluctuations.

Government and public health agencies for infectious disease vaccine supply

This segment is characterized by large-scale supply agreements, particularly for pandemic preparedness and seasonal vaccines, though recent revenue has been lower due to supply agreement activity changes.

• Revenue decline in Q3 2025 was partly attributed to reduced revenue from government agencies.
• The company has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus.
• Work on the BARDA pandemic flu program (ARCT-2304) had Phase 1 results expected in 2025, funded under contract number 75A50122C00007.
• A definitive supply agreement was executed with the Israeli Ministry of Health for the COVID-19 vaccine candidate (ARCT-021).

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Cost Structure

High Research and Development (R&D) expenses are central to Arcturus Therapeutics Holdings Inc.'s cost structure, reflecting the intensive nature of advancing its messenger RNA (mRNA) pipeline, specifically ARCT-032 for cystic fibrosis (CF) and ARCT-810 for ornithine transcarbamylase (OTC) deficiency.

Total operating expenses were $119.8 million for the nine months ended 9/30/2025.

The company's cost breakdown for the nine months ended September 30, 2025, shows a significant shift in spending priorities:

Manufacturing and clinical trial costs, which are primary components of R&D, saw reductions due to program transitions. The decrease in R&D expenses was primarily driven by lower manufacturing costs for the LUNAR-COVID program, reflecting its transition to the commercial phase, and additional decreases from LUNAR-FLU and LUNAR-CF programs. Still, these reductions were partially offset by higher clinical costs for Phase 2 of the LUNAR-CF program.

General and administrative (G&A) expenses also showed a downward trend, which you'd expect given the focus on core development. For the three months ended September 30, 2025, G&A expenses totaled $10.4 million, down from $13.3 million in the third quarter of 2024. These expenses cover necessary overhead, including patent maintenance and legal fees, though the company expects G&A to continue to decrease slightly in fiscal year 26, driven by lower share-based compensation costs.

The cost management strategy is clear: focus spending on the highest-potential assets while reducing burn. This is supported by the balance sheet position and forward-looking statements:

• Cash, cash equivalents and restricted cash stood at $237.3 million as of September 30, 2025.
• The U.S. BLA filing for KOSTAIVE was delayed indefinitely due to FDA regulatory changes.
• Additional cost reductions were planned in the fourth quarter of 2025.
• These actions, combined with delaying the Phase 3 CF clinical trial commencement until 2027, extend the cash runway into 2028.

The CFO confirmed the decision to reduce additional expenses to extend the runway specifically for the CF and OTC deficiency programs.

Arcturus Therapeutics Holdings Inc. (ARCT) - Canvas Business Model: Revenue Streams

You're looking at the financial engine of Arcturus Therapeutics Holdings Inc. (ARCT) as of late 2025. The revenue picture is dominated by partnerships right now, with the transition of KOSTAIVE® affecting the recognition schedule.

The total recognized revenue for the nine months ended September 30, 2025, was $74.8 million. This figure is down significantly from the $129.54 million reported for the same nine-month period in 2024.

Collaboration revenue from partners is the core component. This includes license fees, consulting fees, technology transfer fees, reservation fees, and collaborative payments from research and development arrangements with biotechnology and pharmaceutical partners. The recent revenue decline was primarily driven by reduced revenue from the CSL collaboration, which reflects lower supply agreement activity and a lower amortization of the upfront payment as KOSTAIVE progresses toward commercialization.

Here's a snapshot of the key financial metrics around these revenue streams:

Regarding commercial product sales, KOSTAIVE®, the self-amplifying mRNA COVID vaccine, is approved in Japan through the joint venture ARCALIS and partner Meiji Seika Pharma. While the structure involves a potential net profit share, the specific financial terms for this stream aren't detailed in the latest filings, though the transition away from development revenue has impacted current figures. The U.S. BLA filing for KOSTAIVE has been delayed indefinitely due to changes in FDA regulatory requirements.

Grant revenue from government agencies for specific vaccine development programs is another source, though it contributed to the overall revenue decline for the nine-month period. For example, the ARCT-2304 H5N1 vaccine candidate has received support from the U.S. Department of Health and Human Services/BARDA under contract number 75A50122C0007.

Future product sales from wholly-owned rare disease therapeutics post-regulatory approval represent the next major potential revenue shift. Arcturus Therapeutics Holdings Inc. is focused on advancing these candidates:

• ARCT-032 for cystic fibrosis (CF), with interim Phase 2 data expected from the first nine enrolled participants in September 2025.
• ARCT-810 for ornithine transcarbamylase (OTC) deficiency, with ongoing Phase 2 dosing.

The company is planning a 12-week safety and preliminary efficacy study for ARCT-032 to start in the first half of 2026. The successful progression of these wholly-owned assets is key to future, non-collaboration-dependent revenue streams.

Finance: draft 13-week cash view by Friday.