Here are 1-3 brief analogies for Arcturus Therapeutics:

• A Moderna or BioNTech, but with a focus on its proprietary mRNA delivery system for a broad range of therapeutics.
• Like a developing Moderna (or BioNTech) that is building out a diverse pipeline of mRNA medicines.

• ARCT-154 (VBC-0154): A self-amplifying mRNA vaccine for COVID-19, approved for use in Japan.
• ARCT-032: An investigational inhaled mRNA therapeutic designed to treat Cystic Fibrosis.
• ARCT-810: An investigational mRNA therapeutic targeting Ornithine Transcarbamylase (OTC) Deficiency, a rare genetic metabolic disorder.

Arcturus Therapeutics (ARCT) primarily operates under a business-to-business (B2B) model, focusing on developing and licensing its mRNA technology and drug candidates rather than selling directly to individuals. Its major "customers" are typically other pharmaceutical companies, governments, and healthcare organizations that acquire licenses for development, commercialization rights, or directly purchase vaccine supplies.

Based on publicly available information, a key customer and partner is:

• Meiji Seika Pharma Co., Ltd.: A Japanese pharmaceutical company. Arcturus has an exclusive license agreement with Meiji Seika Pharma for the development, manufacturing, and commercialization of its COVID-19 vaccine (ARCT-154, now approved as ARCT-2131) in Japan. While Meiji Seika Pharma Co., Ltd. is a private subsidiary, its parent company is Meiji Holdings Co., Ltd. (TYO: 2269). Meiji Seika Pharma then supplies the vaccine to the Japanese government and healthcare system.

Historically, Arcturus has also engaged in collaborations with large pharmaceutical companies such as Sanofi and Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), indicating a strategy of partnering with larger entities for broader commercialization and development, although these specific collaborations have since been terminated.

• Lonza Ltd. (LONN)

Joseph E. Payne President & Chief Executive Officer

Joseph E. Payne is the co-founder, President, and Chief Executive Officer of Arcturus Therapeutics, serving on its Board since March 2013. He has over 20 years of drug discovery experience, including positions at Merck Research Labs, DuPont Pharmaceuticals, Bristol-Myers Squibb, Kalypsys, and Nitto.

Andrew Sassine Chief Financial Officer

Andrew Sassine has served as Chief Financial Officer at Arcturus Therapeutics since January 2019. He is also on the Board of Directors of Nasdaq-listed ICAD Inc. Previously, he was a Portfolio Manager at Fidelity Investments from 1999 to 2012, managing funds such as the Fidelity Small Cap Stock Fund and the Fidelity International Small Cap Opportunities Fund. He has served on the boards of other companies including Gemphire Therapeutics, Inc., Acorn Energy, Inc., CNS Response, Inc., FluoroPharma Medical, Inc., MYnd Analytics, Inc., Freedom Meditech, Inc., and MD Revolution, and is Chairman of the Board of privately held ComHear Inc.

Dr. Padmanabh Chivukula Chief Scientific Officer & Chief Operating Officer

Dr. Padmanabh Chivukula is the co-founder of Arcturus Therapeutics and has served as Chief Scientific Officer and Chief Operating Officer since 2013. He leads the company's research and development activities with a strong background in nanoparticle technology. Prior to co-founding Arcturus, he held key roles at Nitto Denko Technical Corporation, including Group Leader and Chief Scientist.

Lance Kurata Chief Legal Officer

Lance Kurata has served as Chief Legal Officer of Arcturus Therapeutics since August 2020. Before joining Arcturus, he was a partner at Mintz Levin from 2006 to 2020, where he chaired the West Coast Technology Transactions Practice. He also served as a partner at Fish & Richardson and practiced corporate law at Brobeck Phleger & Harrison.

Roberta Duncan Chief Strategy Officer

Roberta Duncan is the Chief Strategy Officer at Arcturus Therapeutics, bringing over 26 years of experience in the biopharma industry across start-ups, small biotech, pharma, and CROs. She currently serves as the Board Vice-Chair of the Alliance for mRNA Medicines (AMM) and previously led CSL's enterprise-wide mRNA Program as Vice President.

The key risks to Arcturus Therapeutics (ARCT) include:

1. Clinical Trial Failures and Regulatory Setbacks: The success of Arcturus Therapeutics heavily relies on the outcomes of its clinical trials and subsequent regulatory approvals. The company has experienced setbacks, such as interim Phase 2 data for ARCT-032 in cystic fibrosis (CF) falling short of expectations, which led to a significant drop in stock value. Furthermore, the U.S. Biologics License Application (BLA) for their COVID-19 vaccine, KOSTAIVE, has been delayed due to the Food and Drug Administration (FDA) requiring additional clinical endpoint efficacy study data. Unfavorable clinical trial results, delays in trials, or difficulties in securing regulatory approvals for its pipeline candidates (including those for rare diseases like CF and ornithine transcarbamylase (OTC) deficiency) pose a critical risk to the business.
2. Intense Competition and Market Adoption Hurdles: Arcturus operates in a highly competitive landscape for mRNA therapeutics and vaccines. In the CF market, the company faces significant competition from established players like Vertex Pharmaceuticals, which already dominates with therapies such as Trikafta. For OTC deficiency, other advanced therapeutic modalities, including gene therapies, are also under development by competitors. Additionally, while KOSTAIVE has received regulatory approval in the EU, the COVID-19 vaccine market is mature and declining, making it challenging to generate substantial revenue from this product. The unpredictable nature of the market for pandemic influenza vaccines (like their H5N1 candidate) also presents market adoption risks.
3. Financial Challenges, Cash Burn, and Potential for Dilution: Arcturus Therapeutics has faced ongoing financial challenges, including declining revenues and consistent net losses. The company's revenue streams are significantly influenced by milestone payments from collaborations, such as the CSL Seqirus partnership, which can lead to volatility. While Arcturus has taken steps to extend its cash runway into 2028 through cost-cutting and strategic reallocation of resources, high research and development (R&D) expenses for its multiple programs continue to contribute to cash burn. Should the company not achieve profitability before its cash runway depletes, there is a risk of having to resort to equity raises or debt, which could lead to dilution for existing shareholders.

Arcturus Therapeutics (ARCT) is focused on developing messenger RNA (mRNA) medicines for infectious diseases and rare diseases, with key product candidates targeting Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis (CF), COVID-19, and Influenza.

The addressable markets for their main products or services are as follows:

• ARCT-810 (Ornithine Transcarbamylase Deficiency): The global market for ornithine transcarbamylase deficiency treatment was valued at USD 774.2 million in 2024 and is projected to grow to USD 1.2 billion by 2034. Another estimate indicates the global market was approximately USD 1.2 billion in 2023 and is projected to reach USD 2.3 billion by 2032. The North American market alone for OTC deficiency treatment was valued at USD 315.6 million in 2024. Across the top 7 markets (US, EU4, UK, and Japan), the market reached USD 689.1 million in 2024 and is expected to reach USD 1,044.7 million by 2035.
• ARCT-032 (Cystic Fibrosis): The global cystic fibrosis market was valued at USD 10.36 billion in 2023 and is expected to reach USD 56.72 billion by 2032. Another report estimated the global cystic fibrosis therapeutics market at USD 10.34 billion in 2024, growing to approximately USD 39.15 billion by 2034. The U.S. cystic fibrosis market was valued at USD 3.92 billion in 2023 and is expected to reach USD 21.73 billion by 2032. The market for cystic fibrosis across the top 7 markets (US, EU4, UK, and Japan) was valued at USD 11,986.4 million in 2024 and is projected to reach USD 74,535.4 million by 2035.
• KOSTAIVE (ARCT-154) (COVID-19 Vaccine): The global COVID-19 vaccine market was valued at USD 7.68 billion in 2024 and is projected to grow to USD 14.32 billion by 2033. Other estimates place the global COVID-19 vaccine market at US$ 13.43 billion in 2024, expected to reach US$ 29.98 billion by 2033. However, some projections indicate a decline, with the market at USD 13.71 billion in 2025 and projected to contract to USD 8.28 billion by 2030.
• LUNAR-FLU (ARCT-2138) / ARCT-2304 (Influenza Vaccine): The global influenza vaccine market was valued at USD 7.2 billion in 2024 and is estimated to reach USD 12.8 billion by 2033. Another report valued the global market at USD 8.37 billion in 2024, projected to reach USD 18.02 billion by 2034. North America dominated this market, holding over 53.4% of the market share in 2024. The U.S. influenza vaccine market alone was valued at USD 2.76 billion in 2024 and is expected to reach USD 6.06 billion by 2034.

Arcturus Therapeutics (ARCT) is anticipated to drive future revenue growth over the next 2-3 years through several key initiatives:

1. Commercialization and Expansion of KOSTAIVE® (COVID-19 Vaccine): Arcturus Therapeutics expects revenue from its COVID-19 vaccine, KOSTAIVE®, with regulatory submissions and approvals underway in key markets. A Marketing Authorization Application (MAA) was filed by CSL to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in Q2 2025, with approval expected by September 2025. Additionally, NDA applications were filed by Meiji Seika Pharma to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in H1 2025, with anticipated approvals in Q3/Q4 2025. A U.S. Biologics License Application (BLA) filing to the FDA is on track for Q3 2025, with an approval decision expected in 2026.

2. Advancement of Cystic Fibrosis (ARCT-032) Therapeutic: The company is progressing with its ARCT-032 program for cystic fibrosis. Phase 2 interim data from the first nine participants is expected in September 2025, and the Phase 2 trial is projected to complete enrollment by the end of 2025. Meetings with the FDA and other regulatory agencies to discuss Phase 2 data and plans for pivotal trials are anticipated in the first half of 2026. Successful progression through clinical trials and potential regulatory approval would open a significant new market for Arcturus.

3. Development of Ornithine Transcarbamylase (OTC) Deficiency Therapeutic (ARCT-810): Arcturus is also advancing ARCT-810 for OTC deficiency. The company has reported positive interim Phase 2 data, and alignment with regulatory agencies on the Phase 3 trial design is expected in the first half of 2026. The successful development and commercialization of ARCT-810 would introduce another novel therapeutic to the market.

4. Strategic Alliances and Collaboration Revenue: Arcturus maintains ongoing global collaborations, including with CSL Seqirus for innovative mRNA vaccines and a joint venture in Japan, ARCALIS, focused on manufacturing mRNA vaccines and therapeutics. The company's revenue streams from these partnerships include license fees, consulting and technology transfer fees, reservation fees, and collaborative payments from research and development arrangements. An initial European Union (EU) approval milestone payment from the partnership with CSL was received in Q1 2025. Future milestone payments and potential profit-sharing agreements from these collaborations are expected to contribute to revenue growth.

Share Issuance

• In July 2020, Arcturus Therapeutics priced a public offering of 3,264,151 shares of common stock at $53.00 per share, generating approximately $173.0 million in gross proceeds.
• In April 2020, the company completed a public offering of 4,735,297 shares of common stock at $17.00 per share, including the full exercise of the underwriters' option, resulting in total gross proceeds of approximately $80.5 million.
• The net proceeds from these offerings were intended for working capital, general corporate purposes, and to advance the company's LUNAR-COV19 vaccine candidate, LUNAR-OTC, and other preclinical programs into clinical development.

Inbound Investments

• Arcturus Therapeutics has established ongoing global collaborations for innovative mRNA vaccines with CSL Seqirus and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics.
• In the first quarter of 2025, Arcturus received an initial milestone payment from CSL related to the EU approval of KOSTAIVE, with an additional milestone payment anticipated.
• As of March 31, 2025, the company reported a cash balance of $273.8 million, with its cash runway extended into 2028, supported by strong partnership funding.

Outbound Investments

• Arcturus Therapeutics has not made any significant investments or acquisitions in other companies.

Capital Expenditures

• Research and development expenses, which include facility-related expenses and laboratory supplies, were $64.5 million for the first six months of 2025, a decrease from $112.2 million in the same period of 2024. This reduction was primarily due to lower manufacturing and clinical costs for the KOSTAIVE program as it moved towards commercialization, and reduced facilities and equipment costs, partially offset by increased clinical expenses for the cystic fibrosis program.
• For the first quarter of 2025, research and development expenses were $34.9 million, down from $53.6 million in the comparable period of 2024. This decrease was mainly driven by lower manufacturing costs for KOSTAIVE, LUNAR-FLU, and BARDA programs, balanced by increased manufacturing and clinical costs for the LUNAR-CF and LUNAR-OTC programs.
• The company anticipates additional quarterly declines in research and development expenses during the second half of fiscal year 2025.