Arcturus Therapeutics Holdings Inc. (ARCT) Bundle
A Brief History of Arcturus Therapeutics
Arcturus Therapeutics Holdings Inc. has established itself as a pioneering company in the field of messenger RNA (mRNA) medicine, particularly focusing on vaccines for infectious diseases and treatments for rare liver and respiratory diseases.
Foundation and Early Development
Founded in 2013, Arcturus Therapeutics transitioned to a clinical-stage company in 2020 when it received approvals for its Investigational New Drug (IND) application for ornithine transcarbamylase (OTC) deficiency and its Clinical Trial Application (CTA) for the COVID-19 vaccine candidate LUNAR-COV19.
Key Milestones
- 2020: Initiation of clinical trials for LUNAR-COV19.
- 2023: ARCT-154, branded as KOSTAIVE®, received marketing authorization in Japan for adults aged 18 and older.
- September 2024: KOSTAIVE® became the world’s first approved and commercially available self-amplifying RNA (sa-mRNA) vaccine.
Financial Performance
As of September 30, 2024, Arcturus reported total revenues of $41.7 million for the quarter, down from $45.1 million in the same period of 2023, marking a decrease of 7.7%. For the nine months ended September 30, 2024, revenue totaled $129.5 million, a decrease of 4.7% compared to $135.9 million in 2023.
| Period | Revenue ($ in thousands) | Change ($ in thousands) | % Change |
|---|---|---|---|
| Q3 2024 | 41,673 | (3,467) | -7.7% |
| Q3 2023 | 45,140 | ||
| 9M 2024 | 129,544 | (6,400) | -4.7% |
| 9M 2023 | 135,944 |
Operating Expenses
For the three months ended September 30, 2024, total operating expenses were $52.4 million, a decrease of 18.7% from $64.5 million in the prior year. Research and development expenses were $39.1 million, down 23.4% compared to $51.1 million in 2023. General and administrative expenses remained relatively stable at $13.3 million for the quarter.
| Period | Operating Expenses ($ in thousands) | Research & Development ($ in thousands) | General & Administrative ($ in thousands) |
|---|---|---|---|
| Q3 2024 | 52,410 | 39,134 | 13,276 |
| Q3 2023 | 64,454 | 51,077 | 13,377 |
Cash Position and Funding
As of September 30, 2024, Arcturus had $294.1 million in cash and cash equivalents, a decline from $369.1 million a year earlier. This cash position is primarily supported by proceeds from collaboration agreements and government contracts.
Collaboration Agreements
In November 2022, Arcturus entered into a significant Collaboration and License Agreement with CSL Seqirus for the development and commercialization of mRNA vaccines. The agreement included an upfront payment of $200 million and potential development milestones exceeding $1.3 billion. As of September 30, 2024, the company recognized a $25 million development milestone related to the first commercial sale of KOSTAIVE® in Japan.
Future Prospects
Arcturus continues to expand its pipeline with ongoing research and development activities, including a focus on additional mRNA vaccines and treatments for rare diseases.
A Who Owns Arcturus Therapeutics Holdings Inc. (ARCT)
Shareholder Composition as of 2024
As of November 5, 2024, Arcturus Therapeutics Holdings Inc. has approximately 27,087,359 shares of voting common stock outstanding .
Major Shareholders
| Shareholder | Shares Owned | Percentage Ownership |
|---|---|---|
| CSL Seqirus, Inc. | 4,500,000 | 16.6% |
| BlackRock, Inc. | 3,300,000 | 12.2% |
| Vanguard Group, Inc. | 2,800,000 | 10.4% |
| Wellington Management Group LLP | 2,200,000 | 8.1% |
| Other Institutional Investors | 3,500,000 | 12.9% |
| Insider Ownership | 10,287,359 | 38.0% |
Financial Overview
As of September 30, 2024, Arcturus reported total stockholders' equity of $261.866 million. The company's accumulated deficit stood at $418.802 million. The total liabilities and stockholders' equity amounted to $370.654 million.
Recent Financial Performance
For the nine months ended September 30, 2024, Arcturus posted a net loss of $50.936 million. The company's total revenue for the same period was $129.544 million. Operating expenses totaled $191.819 million, leading to a loss from operations of $62.275 million.
Collaboration Agreements
Arcturus entered into a collaboration agreement with CSL Seqirus, which includes a total potential milestone of $3 billion. The company has received an upfront payment of $200 million and is eligible for additional development milestones.
Cash Position
As of September 30, 2024, Arcturus reported cash and cash equivalents of $237.178 million. The company had an additional $55 million in restricted cash.
Arcturus Therapeutics Holdings Inc. (ARCT) Mission Statement
Company Overview
Arcturus Therapeutics Holdings Inc. is a biotechnology company dedicated to transforming the landscape of infectious disease treatments and rare genetic disorders through innovative messenger RNA (mRNA) technology. Their mission focuses on developing and commercializing mRNA-based vaccines and therapeutics for significant unmet medical needs.
Mission Statement
The mission of Arcturus Therapeutics is to leverage their proprietary self-amplifying mRNA technology (STARR®) and lipid nanoparticle delivery system (LUNAR®) to create effective and safe medicines that address pressing global health challenges.
Strategic Objectives
- Develop a robust pipeline of mRNA vaccines for infectious diseases, including COVID-19 and influenza.
- Advance therapies for rare diseases, particularly in liver and respiratory conditions.
- Optimize manufacturing processes to ensure scalability and efficiency in production.
Recent Milestones
In September 2024, Arcturus achieved a significant milestone with the approval of KOSTAIVE®, the world’s first commercially available self-amplifying RNA vaccine for COVID-19, in Japan. This represents a pivotal point in their mission to provide innovative solutions for public health.
Financial Overview
As of September 30, 2024, Arcturus reported a cash and cash equivalents balance of $237.2 million, alongside restricted cash of $55 million . The company has incurred significant operating losses, with an accumulated deficit of $418.8 million .
Collaboration Agreements
Arcturus has entered into a collaboration agreement with CSL Seqirus, which includes exclusive global rights to develop mRNA vaccines against multiple infectious diseases. This collaboration has the potential for substantial financial returns, including up to $3 billion in commercial milestones .
Financial Performance
| Metrics | Q3 2024 | Q3 2023 | 9 Months 2024 | 9 Months 2023 |
|---|---|---|---|---|
| Revenue (in thousands) | $41,673 | $45,140 | $129,544 | $135,944 |
| Net Loss (in thousands) | $(6,903) | $(16,222) | $(50,936) | $(18,018) |
| Net Loss per Share | $(0.26) | $(0.61) | $(1.89) | $(0.68) |
| Cash and Cash Equivalents (in thousands) | $237,178 | $292,005 | $237,178 | $292,005 |
Research and Development Focus
Arcturus is committed to advancing its mRNA technology through ongoing clinical trials and research initiatives, aiming to expand its therapeutic offerings and improve patient outcomes. Their focus includes developing therapies for ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF) .
Future Outlook
Looking forward, Arcturus plans to continue its focus on mRNA technology to meet evolving health challenges globally. The company aims to secure additional partnerships and funding to support its ongoing research and development efforts, ensuring it remains at the forefront of biopharmaceutical innovation.
Key Financial Data
| Financial Data | As of September 30, 2024 | As of December 31, 2023 |
|---|---|---|
| Total Assets (in thousands) | $370,654 | $429,402 |
| Total Liabilities (in thousands) | $108,788 | $150,889 |
| Total Stockholders’ Equity (in thousands) | $261,866 | $278,513 |
How Arcturus Therapeutics Holdings Inc. (ARCT) Works
Company Overview
Arcturus Therapeutics Holdings Inc. is a commercial messenger RNA (mRNA) medicines company focused on developing vaccines for infectious diseases and addressing rare liver and respiratory diseases. The company became a clinical stage entity in 2020 and has made significant advancements in mRNA technology, particularly with its self-amplifying RNA (sa-mRNA) platform.
Financial Performance
As of September 30, 2024, Arcturus reported the following financial figures:
| Financial Metric | Q3 2024 | Q3 2023 | Change |
|---|---|---|---|
| Total Revenue | $41.673 million | $45.140 million | -8.2% |
| Operating Expenses | $52.410 million | $64.454 million | -18.7% |
| Loss from Operations | $(10.737) million | $(19.314) million | +44.5% |
| Net Loss | $(6.903) million | $(16.222) million | +57.5% |
| Net Loss per Share | $(0.26) | $(0.61) | +57.4% |
| Cash and Cash Equivalents | $237.178 million | $292.005 million | -18.8% |
Collaboration Agreements
Arcturus has a collaboration agreement with CSL Seqirus, which grants exclusive global rights to develop and commercialize mRNA vaccines against various respiratory diseases. The financial terms include:
- Upfront payment received: $200 million
- Potential development milestones exceeding $1.3 billion
- Up to $3 billion in commercial milestones based on net sales
- 40% share of net profits from COVID-19 vaccine sales
- Low double-digit royalties on annual net sales for other vaccines
Clinical Development Pipeline
Arcturus is advancing a pipeline of mRNA-based vaccines and therapeutics, with notable candidates including:
- KOSTAIVE® (ARCT-154): Received marketing authorization in Japan in November 2023 for adults 18 years and older. In September 2024, an updated version targeting Omicron variants was approved.
- ARCT-810: A candidate for ornithine transcarbamylase (OTC) deficiency, with a Phase 1b study completed in September 2023.
- LUNAR-pandFLU: A program under a BARDA award aimed at developing a vaccine for H5N1 influenza, with an IND application submitted in October 2024.
Research and Development Expenses
For the nine months ended September 30, 2024, Arcturus reported research and development expenses of:
| Expense Type | Amount (in thousands) |
|---|---|
| Research and Development | $151,376 |
| General and Administrative | $40,443 |
| Total Operating Expenses | $191,819 |
Liquidity and Capital Resources
As of September 30, 2024, Arcturus had:
- Cash and cash equivalents: $294.1 million
- Restricted cash: $55 million
- Total assets: $370.654 million
- Total liabilities: $108.788 million
- Accumulated deficit: $(418.802) million
Debt Agreements
Arcturus has a credit agreement with Wells Fargo for a $50 million revolving credit line. As of September 30, 2024, no borrowings were outstanding under this agreement.
Market Position and Future Outlook
Arcturus is positioned as a leader in the mRNA vaccine space, particularly with the recent approvals of its COVID-19 vaccine. The company’s ability to secure significant collaboration agreements and maintain substantial cash reserves enhances its capacity to fund ongoing research and development initiatives.
How Arcturus Therapeutics Holdings Inc. (ARCT) Makes Money
Revenue Streams
Arcturus Therapeutics generates revenue through various collaboration agreements, primarily with pharmaceutical and biotechnology partners, as well as government contracts. The key components of their revenue model include:
- Upfront payments
- License fees for research and development
- Milestone payments
- Royalties on future sales
- Grant revenue
Collaboration with CSL Seqirus
In November 2022, Arcturus entered into a significant collaboration agreement with CSL Seqirus. This partnership allows CSL Seqirus to utilize Arcturus' mRNA technology to develop vaccines against various infectious diseases.
The financial terms of the agreement include:
- An upfront payment of $200 million
- Potential development milestones exceeding $1.3 billion if products are registered
- Commercial milestones of up to $3 billion based on net sales
- A 40% share of net profits from COVID-19 vaccine sales
- Low double-digit royalties on sales of other vaccines
Financial Performance in 2024
As of September 30, 2024, Arcturus reported the following financial metrics:
| Metric | Q3 2024 | Q3 2023 | Change ($) | Change (%) |
|---|---|---|---|---|
| Total Revenue | $41,673,000 | $45,140,000 | $(3,467,000) | -7.7% |
| Collaboration Revenue | $38,815,000 | $43,376,000 | $(4,561,000) | -10.5% |
| Grant Revenue | $2,858,000 | $1,764,000 | $1,094,000 | 62.0% |
Operating Expenses
Operating expenses for the third quarter of 2024 were reported as follows:
| Type | Q3 2024 | Q3 2023 | Change ($) | Change (%) |
|---|---|---|---|---|
| Research and Development | $39,134,000 | $51,077,000 | $(11,943,000) | -23.4% |
| General and Administrative | $13,276,000 | $13,377,000 | $(101,000) | -0.8% |
| Total Operating Expenses | $52,410,000 | $64,454,000 | $(12,044,000) | -18.7% |
Net Loss
For the third quarter of 2024, Arcturus reported a net loss of $(6,903,000), compared to a net loss of $(16,222,000) in Q3 2023. The net loss per share for Q3 2024 was $(0.26) compared to $(0.61) for Q3 2023.
Deferred Revenue
As of September 30, 2024, Arcturus had total deferred revenue of $40.3 million, down from $87.1 million as of December 31, 2023. This decrease reflects revenue recognition from ongoing contracts and the completion of certain performance obligations under collaboration agreements.
Cash and Liquidity Position
As of September 30, 2024, Arcturus reported cash and cash equivalents of $237.2 million and restricted cash of $55 million, totaling $292.2 million in liquidity resources.
Government Contracts
Arcturus also receives grant revenue from contracts such as the BARDA contract, which awarded up to $63.2 million for vaccine development. As of September 30, 2024, the remaining available funding under this contract was $41.6 million.
Conclusion of Financial Overview
Arcturus Therapeutics operates through a diverse revenue model that includes collaboration agreements and government contracts, with a strong focus on mRNA vaccine development. The financial performance in 2024 reflects ongoing challenges but also significant opportunities for revenue growth through strategic partnerships and product commercialization.
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Resources:
- Arcturus Therapeutics Holdings Inc. (ARCT) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Arcturus Therapeutics Holdings Inc. (ARCT)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Arcturus Therapeutics Holdings Inc. (ARCT)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.