Arcturus Therapeutics Holdings Inc. (ARCT): Marketing Mix Analysis [Dec-2025 Updated]

You're likely tracking this biotech because the vaccine chapter is closing, and the real test-the pivot to rare disease therapeutics like ARCT-032 and ARCT-810-is now front and center. Honestly, the financials reflect this shift: revenue for the nine months ending September 30, 2025, hit $74.8 million, but that number is getting pressured as older supply deals slow down. So, we can't just look at the past; we need to dissect their current go-to-market plan. I've mapped out the four P's-Product, Place, Promotion, and Price-to give you a clear, precise view of how they're positioning their STARR® platform for these high-value assets, and where the near-term execution risks are hiding.

Arcturus Therapeutics Holdings Inc. (ARCT) - Marketing Mix: Product

The product element for Arcturus Therapeutics Holdings Inc. centers on its commercialized messenger RNA (mRNA) vaccine and its pipeline of rare disease therapeutics, all built upon its proprietary technology platforms.

KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine to be approved, is the company's commercial product in partner territories. Meiji Seika Pharma launched a two-dose vial of KOSTAIVE updated for the JN. 1 variant XEC in Japan after receiving approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in August 2025. Furthermore, the European Commission approved KOSTAIVE in February 2025, opening access to a market of 30 countries. The U.S. Biologics License Application (BLA) filing for KOSTAIVE has been delayed indefinitely due to sudden changes in FDA regulatory requirements. Arcturus Therapeutics has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus.

The core value proposition of Arcturus Therapeutics Holdings Inc. resides in its enabling technologies, specifically the STARR® sa-mRNA technology and the LUNAR® delivery platform. The STARR® Technology is designed to amplify mRNA within cells, which is intended to result in lower dose requirements and stronger immune responses. The company's extensive patent portfolio covers over 500 patents and patent applications across the U.S., Europe, Japan, China, and other countries, protecting these core technologies.

The strategic focus has shifted toward rare disease therapeutics, which involved pruning early-stage vaccine development efforts, though partnered vaccine programs continue. The company is advancing its lead therapeutic candidates through clinical trials, with specific data points and milestones guiding near-term development plans.

The pipeline includes several other vaccine candidates leveraging the STARR® platform:

• KOSTAIVE® Bivalent (ARCT-2301) is in Phase 3.
• KOSTAIVE® XBB.1.5 (ARCT-2303) is in Phase 3.
• LUNAR®-FLU (ARCT-2138) for Seasonal Influenza is in Phase 1.

For the ARCT-2304 H5N1 vaccine candidate, the Phase 1 study evaluated three different dose levels: 1.5 µg, 5 µg, and 12 µg, all of which were reported as well-tolerated with no safety concerns raised from available data.

Arcturus Therapeutics Holdings Inc. (ARCT) - Marketing Mix: Place

The Place strategy for Arcturus Therapeutics Holdings Inc. (ARCT) is highly segmented, reflecting the dual nature of its business: partnered vaccine commercialization and wholly-owned therapeutic development. Distribution channels are defined by the product lifecycle stage and geographic market.

Global Vaccine Distribution via Strategic Alliances

Global distribution for the KOSTAIVE® vaccine relies heavily on established partners. Arcturus Therapeutics has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, a major player in the influenza vaccine market, covering COVID-19 and influenza programs. This partnership dictates the regulatory submissions and subsequent market access across various territories outside of Japan. For instance, CSL Seqirus submitted a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in Q2 2025, with approval anticipated in the first quarter of 2026. Arcturus anticipates continued support from CSL Seqirus to commercialize KOSTAIVE in Asia and Europe.

Localized Manufacturing Support in Japan

Manufacturing capacity for commercial supply is supported by the Japanese joint venture, ARCALIS, which is focused on the manufacture of mRNA vaccines and therapeutics. Arcturus Therapeutics holds a 49% equity position in ARCALIS, which is subject to dilution. This facility received Ministry of Health, Labour and Welfare (MHLW) approval for commercial manufacturing sites in Japan for KOSTAIVE in January 2025. This local manufacturing capability supports the Japanese commercial channel.

Active Commercial Sales in Japan

Commercial sales for KOSTAIVE® are active in Japan through the exclusive partner, Meiji Seika Pharma. Meiji Seika Pharma launched the two-dose vial of KOSTAIVE updated for the JN.1 variant XEC in Japan, receiving approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in August 2025. The initial commercial validation was marked by the achievement of a $25 Million commercial milestone upon the first sale of KOSTAIVE® in Japan (reported in late 2024). As of late 2024, there was a pricing guidance of JPY 10,000 per dose, equating to approximately $68.5 per dose based on a 146 USD/JPY exchange rate, for a reported order of 4M doses.

Delayed U.S. Market Entry

The planned U.S. market entry for KOSTAIVE® has faced significant setbacks due to evolving regulatory requirements. The Biologics License Application (BLA) filing to the U.S. Food and Drug Administration (FDA), previously targeted for Q3 2025, was delayed. Specifically, the FDA requested a delay to the planned BLA submission in September 2025. The Chief Financial Officer confirmed that sudden changes in regulatory requirements by the FDA for COVID-19 vaccines have delayed the U.S. BLA filing for KOSTAIVE® indefinitely.

Therapeutics Distribution via Clinical Sites

The distribution for the wholly-owned therapeutics candidates, ARCT-032 (Cystic Fibrosis) and ARCT-810 (OTC deficiency), is currently limited to specialized clinical trial sites as they progress through late-stage development. The ARCT-032 Phase 2 study (NCT06747858) is enrolling, and the company plans to initiate a 12-week safety and preliminary efficacy study in up to 20 CF participants in the first half of 2026. For ARCT-810, Phase 2 studies have involved a total of 40 participants to date, including 20 OTC deficient participants in the U.S. study (NCT06488313).

Here is a quick view of the distribution channels and associated numbers:

The therapeutics pipeline distribution is entirely dependent on clinical site networks for enrollment, which is a necessary but temporary distribution method.

• ARCT-032 Phase 2 enrollment expected to complete by year-end 2025.
• Pivotal trial design alignment with FDA for ARCT-810 expected in H1 2026.
• The company is actively reducing expenses to extend the cash runway for these therapeutic programs into 2028.

You'll want Finance to track the CSL revenue recognition closely, as the transition from development to commercialization for KOSTAIVE is shifting revenue streams, with reported revenue for the three months ended June 30, 2025, at $28.3 million, down from $49.9 million in the same period in 2024.

Arcturus Therapeutics Holdings Inc. (ARCT) - Marketing Mix: Promotion

You're looking at how Arcturus Therapeutics Holdings Inc. communicates its science and pipeline progress to the market, which is heavily weighted toward the financial community given its stage. The promotion strategy centers on disseminating clinical milestones and platform validation through formal financial reporting and targeted industry events.

Primary communication is via investor relations and financial conferences.

Arcturus Therapeutics actively engages with the investment community through scheduled appearances and earnings calls. For instance, the company announced participation in the Piper Sandler 37th Annual Healthcare Conference with a Fireside Chat scheduled for December 2, 2025, at 12:30 p.m. ET. Earlier in the fall, Arcturus Therapeutics held its Third Quarter 2025 Earnings Call on Monday, November 10, 2025, at 4:30 p.m. ET, following its Second Quarter 2025 Earnings Call on July 29, 2025. The VP, Head of IR/PR/Marketing, Neda Safarzadeh, is the key contact point at (858) 900-2682 or IR@ArcturusRx.com. You can see the cadence of these engagements below.

Press releases highlight positive Phase 2 interim data for ARCT-032 and ARCT-810.

Key clinical readouts are immediately translated into press releases to inform the market. For ARCT-032 in cystic fibrosis (CF), interim data from the Phase 2 trial was announced in October 2025. Specifically, after 28 days of treatment with inhaled 10 mg doses of ARCT-032 daily in six Class I CF adults, four out of six participants showed an encouraging reduction in mucus plug number and mucus volume. This data supports a planned 12-week safety and preliminary efficacy study in up to 20 CF participants slated to start in H1 2026. For ARCT-810 in Ornithine Transcarbamylase (OTC) deficiency, positive interim Phase 2 data was shared in August 2025, showing mean ammonia levels remained stable within the normal range for approximately 28 days post-dosing.

Messaging emphasizes the STARR® platform's low-dose, high-potency advantage.

The core technological differentiator, the STARR® self-amplifying mRNA (sa-mRNA) platform, is promoted by emphasizing its efficiency. This technology is designed to make many copies of mRNA within the host cell, enabling lower doses than conventional mRNA vaccines. Data from the ARCT-2304 H5N1 program supported this, showing a single dose at 1.5, 5, and 12 µg induced an immune response similar to or higher than the MF59-adjuvanted pandemic vaccine. The robust safety database for the LUNAR® and STARR® technologies was established across multiple trials involving more than 20,000 participants and dose ranges from 1 to 20 mcg of mRNA. The platform's versatility is underscored by the fact that its technologies are covered by an extensive patent portfolio of over 500 patents and patent applications.

Partner-led public health and commercial marketing for KOSTAIVE® in Asia and Europe.

Commercial promotion for the approved COVID-19 vaccine, KOSTAIVE®, is primarily led by partners CSL Seqirus and Meiji Seika Pharma. The European Commission granted marketing authorization in February 2025. CSL filed a Marketing Authorization Application (MAA) to the UK MHRA in Q2 2025, with approval anticipated by September 2025. In Asia, Meiji Seika Pharma launched the two-dose vial updated for the JN.1 variant XEC in Japan in August 2025, receiving PMDA approval. However, the U.S. BLA filing was delayed indefinitely. Arcturus Therapeutics anticipates continued support from CSL for commercialization efforts in Asia and Europe.

Corporate updates are disseminated through X and LinkedIn channels.

Beyond formal financial releases, Arcturus Therapeutics uses social media platforms to keep stakeholders informed. You can find corporate updates, including announcements of investor conference attendance and pipeline progress, disseminated through the company's official X (formerly Twitter) and LinkedIn channels. These channels serve as immediate conduits for news, complementing the more detailed information found in SEC filings and investor presentations.

• ARCT-032 Phase 2 enrollment expected to complete by year end 2025.
• ARCT-810 pivotal trial design alignment with regulators expected H1 2026.
• ARCT-2304 Phase 1 interim data expected in H2 2025.
• Cash runway extended into 2028 based on Q4 2025 cost reductions.

Arcturus Therapeutics Holdings Inc. (ARCT) - Marketing Mix: Price

You're looking at the pricing component for Arcturus Therapeutics Holdings Inc. (ARCT), and the reality here is that for late 2025, the 'price' isn't about a sticker price for a consumer product. Instead, it's about the financial structures embedded within its strategic partnerships.

Arcturus Therapeutics Holdings Inc.'s primary revenue is collaboration-based, not derived from direct product sales pricing in the traditional sense. This means the money comes from upfront payments, research milestones, and royalties tied to the progress of its partnered assets, like the KOSTAIVE® vaccine and its pipeline therapeutics.

The financial performance reflects this structure. Total revenue for the nine months ended September 30, 2025, was $74.8 million. This figure shows a clear trend when you look at the comparison points:

This revenue is decreasing, and the main driver is the reduced activity under the CSL Seqirus collaboration. Specifically, revenue is declining due to lower supply agreement activity as the KOSTAIVE® program moves further into its commercialization phase, which changes how the upfront payment amortization is recognized.

Still, specific, large, non-recurring payments act as significant pricing events within these agreements. Arcturus Therapeutics Holdings Inc. received a $25 million milestone payment from Meiji Seika Pharma, which was triggered by the launch of KOSTAIVE® in Japan. That's a concrete, large sum realized from a pre-agreed pricing structure upon a key commercial event.

Looking ahead, the pricing strategy for its internal pipeline candidates, ARCT-032 for cystic fibrosis and ARCT-810 for ornithine transcarbamylase (OTC) deficiency, is set to follow a high-value, rare disease model. This implies premium pricing, typical for therapies addressing unmet needs in small patient populations, often supported by orphan drug designations.

The financial context underpinning this future pricing focus is Arcturus Therapeutics Holdings Inc.'s strategic pivot:

• Cash, cash equivalents, and restricted cash stood at $237.3 million as of September 30, 2025.
• The company is prioritizing these therapeutics to extend its cash runway into 2028.
• The focus is on therapies targeting markets with orphan drug designations.

So, the pricing element right now is less about setting a list price and more about realizing the value locked into existing collaboration terms and setting the stage for potentially blockbuster pricing on its rare disease assets.