Arcturus Therapeutics Holdings Inc. is an American RNA medicines biotechnology company focused on the discovery, development and commercialization of therapeutics for rare diseases and infectious diseases. Arcturus has developed proprietary lipid nanoparticle RNA therapeutics for nucleic acid medicines including small interfering RNA (siRNA), messenger RNA (mRNA), gene editing RNA, DNA, antisense oligonucleotides, and microRNA.3Wikipedia text CC BY-SA 4.0
Arcturus Therapeutics Holdings Inc. is an American RNA medicines biotechnology company focused on the discovery, development and commercialization of therapeutics for rare diseases and infectious diseases. Arcturus has developed proprietary lipid nanoparticle RNA therapeutics for nucleic acid medicines including small interfering RNA (siRNA), messenger RNA (mRNA), gene editing RNA, DNA, antisense oligonucleotides, and microRNA.3
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Out of $82.0M in revenue.8 The company lost money this year.
Financial statements
Revenue910118$82.0M in 2025+295% since 2019Operating income910118-$76.3M in 2025+199% since 2019Net income910118-$65.8M in 2025+153% since 2019
Revenue1213$3.0M in Q2 FY2026+44% since Q1 FY2026Operating income1213-$25.5M in Q2 FY2026−12% since Q1 FY2026Net income1213-$23.8M in Q2 FY2026−12% since Q1 FY2026
Every line of the income statement as filed: the last 3 fiscal years, latest first.8
Period ending
2025-12-31
2024-12-31
2023-12-31
Total revenue
$82.0M
$152.3M
$166.8M
Research and development, net
$112.2M
$195.2M
$192.1M
General and administrative
$46.1M
$52.8M
$52.9M
Total operating expenses
$158.3M
$248.0M
$245.0M
Loss from operations
-$76.3M
-$95.7M
-$78.2M
Gain (loss) from foreign currency
$382.0K
-$471.0K
-$229.0K
Finance income, net
$10.1M
$15.2M
$16.6M
Gain on debt extinguishment
$34.0M
Net loss before income taxes
-$65.8M
-$80.9M
-$27.9M
(Benefit) provision for income taxes
-$4.0K
$1.8M
Net loss
-$65.8M
-$80.9M
-$29.7M
Basic
-$2.40
-$3.00
-$1.12
Diluted
-$2.40
-$3.00
-$1.12
Basic
27.4M shares
27.0M shares
26.6M shares
Diluted
27.4M shares
27.0M shares
26.6M shares
Comprehensive loss
-$65.8M
-$80.9M
-$29.7M
No quarter-by-quarter statement was filed.
Total assets1491510118$271.1M in 2025+230% since 2019Total liabilities1491510118$57.2M in 2025+1% since 2019Shareholders’ equity910118$214.0M in 2025+730% since 2019Cash910118$230.9M in 2025+224% since 2019Long-term debt14915$40.6M in 2021+171% since 2019
Total assets1213$224.3M in Q2 FY2026−17% since Q1 FY2025Total liabilities1213$52.5M in Q2 FY2026−8% since Q1 FY2025Shareholders’ equity1213$171.8M in Q2 FY2026−20% since Q1 FY2025Cash1213$191.5M in Q2 FY2026−17% since Q1 FY2025
Every line of the balance sheet as filed: the last 4 fiscal years (annual) or 4 quarters (quarterly), latest first.8
Period ending
2025-12-31
2024-12-31
2023-12-31
2022-12-31
Cash and cash equivalents
$230.9M
$237.0M
$292.0M
Restricted cash
$55.0M
$55.0M
Accounts receivable
$5.6M
$4.0M
Prepaid expenses and other current assets
$5.0M
$10.0M
Total current assets
$241.4M
$306.0M
Property and equipment, net
$6.7M
$9.5M
Operating lease right-of-use asset
$21.1M
$26.7M
Non-current restricted cash
$1.9M
$1.9M
$1.9M
Total assets
$271.1M
$344.1M
Accounts payable
$4.2M
$7.2M
Accrued liabilities
$23.9M
$38.8M
Deferred revenue
$8.2M
$19.5M
Total current liabilities
$36.4M
$65.5M
Deferred revenue, net of current portion
$12.6M
Operating lease liability, net of current portion
$20.8M
$25.0M
Total liabilities
$57.2M
$103.1M
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
$28.0K
$27.0K
Additional paid-in capital
$728.5M
$689.8M
Accumulated deficit
-$514.6M
-$448.8M
Total stockholders equity
$214.0M
$241.0M
$278.5M
$270.3M
Total liabilities and stockholders equity
$271.1M
$344.1M
Common stock, par value
$0.00
$0.00
Common stock, shares authorized
60.0M shares
60.0M shares
Common stock, shares issued
28.4M shares
27.0M shares
Common stock, shares outstanding
28.4M shares
27.0M shares
Period ending
2025-12-31
2024-12-31
2023-12-31
2022-12-31
Cash and cash equivalents
$230.9M
$237.0M
$292.0M
Restricted cash
$55.0M
$55.0M
Accounts receivable
$5.6M
$4.0M
Prepaid expenses and other current assets
$5.0M
$10.0M
Total current assets
$241.4M
$306.0M
Property and equipment, net
$6.7M
$9.5M
Operating lease right-of-use asset
$21.1M
$26.7M
Non-current restricted cash
$1.9M
$1.9M
$1.9M
Total assets
$271.1M
$344.1M
Accounts payable
$4.2M
$7.2M
Accrued liabilities
$23.9M
$38.8M
Deferred revenue
$8.2M
$19.5M
Total current liabilities
$36.4M
$65.5M
Deferred revenue, net of current portion
$12.6M
Operating lease liability, net of current portion
$20.8M
$25.0M
Total liabilities
$57.2M
$103.1M
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
$28.0K
$27.0K
Additional paid-in capital
$728.5M
$689.8M
Accumulated deficit
-$514.6M
-$448.8M
Total stockholders equity
$214.0M
$241.0M
$278.5M
$270.3M
Total liabilities and stockholders equity
$271.1M
$344.1M
Common stock, par value
$0.00
$0.00
Common stock, shares authorized
60.0M shares
60.0M shares
Common stock, shares issued
28.4M shares
27.0M shares
Common stock, shares outstanding
28.4M shares
27.0M shares
Cash from operations910118-$74.3M in 2025+1052% since 2019Capital spending910118$230.0K in 2025−72% since 2019Free cash flow910118-$74.5M in 2025+926% since 2019
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 3 fiscal years, latest first.8
Period ending
2025-12-31
2024-12-31
2023-12-31
Net loss
-$65.8M
-$80.9M
-$29.7M
Depreciation and amortization
$3.0M
$3.5M
$3.0M
Share-based compensation expense
$25.4M
$38.0M
$34.6M
Gain on debt extinguishment
-$34.0M
Foreign currency transaction loss
$382.0K
$471.0K
$90.0K
Other non-cash expenses
$502.0K
Impairment of right-of-use assets
$1.9M
Accounts receivable
-$1.6M
$28.1M
-$29.3M
Prepaid expenses and other current assets
$5.0M
-$2.5M
$1.2M
Right-of-use assets
$3.7M
$4.6M
$4.0M
Accounts payable
-$3.0M
$1.9M
-$2.2M
Accrued liabilities
-$15.3M
$5.9M
-$588.0K
Deferred revenue
-$23.9M
-$55.2M
$38.6M
Lease liabilities
-$4.2M
-$3.6M
-$4.3M
Net cash used in operating activities
-$74.3M
-$59.7M
-$18.1M
Acquisition of property and equipment
-$230.0K
-$648.0K
-$2.9M
Net cash used in investing activities
-$230.0K
-$648.0K
-$2.9M
Proceeds from debt
$15.0M
$20.0M
Proceeds from exercise of stock options
$1.1M
$4.7M
$2.7M
Proceeds from issuance of common stock under equity plans
$585.0K
$682.0K
$609.0K
Proceeds from issuance of common stock, net of issuance costs
$11.7M
Payments on debt obligations
-$15.0M
-$47.4M
Net cash provided by (used in) financing activities
$13.4M
$5.4M
-$24.1M
Net decrease in cash, cash equivalents and restricted cash
-$61.1M
-$55.0M
-$45.1M
Cash paid for interest
$2.1M
Cash paid for income taxes
$1.4M
Right-of-use assets acquired through operating leases
$2.7M
Non-cash asset disposal
$2.3M
$473.0K
Purchase of property and equipment in accounts payable and accrued expenses
Arcturus Therapeutics sits at the top of its group. 4 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Arcturus Therapeutics
Federated HermesFiled SCHEDULE 13G/A on Arcturus Therapeutics, latest Oct 7, 2026 (5 filings since Feb 14, 2022)
ARK Investment Management LLCFiled SCHEDULE 13G/A on Arcturus Therapeutics, latest May 7, 2026 (7 filings since Nov 9, 2021)
VANGUARD GROUP INCFiled SCHEDULE 13G/A on Arcturus Therapeutics, latest Mar 26, 2026 (4 filings since Feb 9, 2023)
BALYASNY ASSET MANAGEMENT L.P.Filed SCHEDULE 13G/A on Arcturus Therapeutics, latest Feb 17, 2026 (2 filings since Nov 14, 2025)
Arcturus Therapeutics Asia Pte. Ltd. Subsidiary · Singapore
Arcturus Therapeutics Europe B.V. Subsidiary · Netherlands
Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G; stakes of 5% or more it reported on Schedules 13D and 13G (1 companies). Each entity in the chart links to its source.
What it owns
What Arcturus Therapeutics reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
We have two properties located in San Diego, California. Our principal place of business is located at 10285 Science Center Drive, San Diego, California. The property consists of approximately 43,234 square feet and is leased through September 2032.
Our other property is located at 10628 Science Center Drive, Suite 250, San Diego, California and consists of approximately 24,700 square feet of office space and laboratory space, which was vacated in December 2025 and is leased through March 2027.
The rest of Item 2
We believe that our property is suitable for the conduct of our business.
Founded in 2013 by Joseph Payne and Pad Chivukula, Arcturus Therapeutics is headquartered in San Diego, California. Initially, they developed a proprietary lipid nanoparticle delivery system called Lunar, able to safely deliver therapeutic RNA or DNA to target cells inside a patient's body.
In September 2017, Arcturus Therapeutics merged with Alcobra Ltd., an Israeli pharmaceutical company. In February of 2018, Joseph Payne was dismissed as president and CEO by the Arcturus Therapeutics board of directors at that time. After ignored requests for a shareholders meeting, Joseph Payne subsequently filed legal proceedings with the Israeli Court which ruled in favor of upholding shareholder rights by sanctioning the meeting of shareholders.
In April of 2018, the Arcturus Therapeutics board of directors at the time filed their own complaint against Joseph Payne and his nominees to the board. In May of 2018, a legal settlement was agreed upon: 4 new directors were appointed to the board (Peter Farrell, Andrew Sassine, James Barlow and Magda Marquet) resulting in the resignation of Stuart Collinson, Daniel Geffken, David Shapiro, and Craig Willett. Other key terms of the settlement agreement included mutual releases of all parties and the agreement by Arcturus Therapeutics and Joseph Payne to terminate all pending litigation.
Lunar is a lipid nanoparticle drug delivery system which targets specific cells inside the body to deliver a payload of RNA into the cell. Once release of the RNA into the cell occurs, the normal translational machinery of the cell can interact with the RNA to make a functional protein with a therapeutic effect. Prior to the Lunar technique, efficient in vivo delivery has also been challenging because existing lipid nanoparticles at the time could cause liver damage and elicit a strong immune response.
This lipid nanoparticle delivery system has been used to deliver ornithine transcarbamylase messenger RNA to liver cells in order to treat citrin deficiency and ornithine transcarbamylase deficiency. OTCD is the most common urea cycle disorder, which impacts an individual's ability to remove toxic waste products from the body. In collaboration with the Salk Institute for Biological Studies in La Jolla, California, successful delivery of a Factor IX messenger RNA to the liver was reported, which suggested viability of the approach to potentially treat diseases requiring protein replacement. Researchers at the MD Anderson Cancer Center also showed the application of mRNA delivered in nanoparticles using the Lunar platform for the treatment of malignancy in intracerebral glioma.
In 2019, a drug named ARCT-810 which uses Lunar, received FDA orphan drug status for treating ornithine transcarbamylase deficiency. The orphan drug designation is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States, and grants seven years of marketing exclusivity after approval. On April 13, 2020, it was announced that the company's investigational new drug application for Phase 1b study in patients with OTCD was allowed to proceed by the U.S. FDA. Clinical trials in patients began in June 2020.
ARCT-021 and Starr
In response to the COVID-19 pandemic, Arcturus partnered with Duke–NUS Medical School to develop a COVID-19 vaccine using a combination of self-replicating mRNA with a Lunar delivery platform which increases the level and duration of expression of a therapeutic protein). The company also partnered with Catalent and Recipharm, contract development and manufacturing organizations, to manufacture multiple batches of Arcturus' COVID-19 mRNA vaccine candidate. Lunar-COV19 clinical trials in healthy volunteers began in July 2020. Phase 2 clinical trials were approved in the United States and Singapore by the FDA and HSA, respectively in December 2020.
Read the full text
Next-generations
On 2 August 2021, ARCT-154 started a clinical trial in Vietnam for next-generation development. The next day, the firm announced that the application of approval for the clinical trial Phase I/II in Singapore called ARCT-165. Also application of ARCT-154 for phase I/II. The vaccine was authorised in Japan in November 2023, and the European Union in February 2025.
Other projects
Lunar-CF is a project in collaboration with the Cystic Fibrosis Foundation to treat cystic fibrosis.
Lunar-FLU is a wholly owned program to protect against the influenza virus. Arcturus is combining its self-replicating mRNA Starr technology with Lunar to develop a prophylactic vaccine against influenza.
Lunar-GSD is a project in collaboration with Ultragenyx to treat glycogen storage disease type III.
Lunar-Rare is a project in collaboration with Ultragenyx to develop therapeutic candidates for rare disease targets.
Lunar-HBV is a project in collaboration with Janssen to develop medicines for the treatment of hepatitis B virus infection.
Lunar-NASH is a project in collaboration with Takeda to develop medicines for non-alcoholic steatohepatitis (NASH) and other gastrointestinal disorders.
Lunar-RPL is a project in collaboration with Synthetic Genomics to develop improved technology for vaccines and therapeutics.
Lunar-AH is a project in collaboration with Synthetic Genomics to develop infectious disease prophylactic vaccines.
Jun 2027Phase 2 trial readout expected Phase 2 trial of ARCT-032 in Cystic Fibrosis: primary completion expected Jun 2027 (ClinicalTrials.gov NCT06747858).57
Drug trials and FDA: recently
Jun 13, 2025Phase 1/2 trial completed Phase 1/2 trial of ARCT-2304, Control vaccine younger adults and others in Influenza, Human: primary completion Jun 13, 2025, results posted Sep 4, 2026 (ClinicalTrials.gov NCT06602531).58
Oct 9, 2024Phase 3 trial completed Phase 3 trial of ARCT-2303, Influenza vaccine and others in COVID-19: primary completion Oct 9, 2024, results posted Dec 12, 2025 (ClinicalTrials.gov NCT06279871).59
Jan 18, 2023Phase 2/3 trial completed Phase 2/3 trial of ARCT-154 Self-Amplifying RNA SARS-CoV-2 Vaccine and Astra Zeneca COVID-19 vaccine in COVID-19 Vaccines, run by Vinbiocare Biotechnology Joint Stock Company: primary completion Jan 18, 2023, results posted Nov 6, 2025 (ClinicalTrials.gov NCT05012943).60
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar
Filings
248 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 60 major events, 93 insider forms, 43 large holders, 32 other. The latest 20:
29 open-market trades by officers, directors and large owners since October 2021: 4 buys and 25 sales. Grants, option exercises and gifts are left out.
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Arcturus Therapeutics is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
From the cover page of the 10-K filed Mar 3, 2026 (Section 12(b) of the Exchange Act).16
Risk factors and legal proceedings
The risks Arcturus Therapeutics names in Item 1A of its 10-K filed Mar 3, 2026: 71 risks under these headings, as written.16
We have a limited operating history, have incurred significant losses since our inception (with the exception of fiscal year 2022) and anticipate that we will continue to incur significant losses for the foreseeable future.
We have not generated any revenue from product sales, have generated only limited collaboration and grant revenue since inception, and may never be profitable in the long term.
We expect that we will need to raise additional capital in the future, which may not be available on acceptable terms, or at all.
We are dependent upon relationships with our collaboration partners, and the failure of these relationships could negatively affect our business and results of operations.
We are highly dependent upon our relationship with CSL Seqirus to further research, manufacture and commercialize self-amplifying mRNA vaccines against COVID-19, influenza and three other infectious diseases; CSL Seqirus has announced a significant write-down of the licensed collaboration programs.
KOSTAIVE might not have a profitable commercial market.
KOSTAIVE only has marketing approval in Japan and Europe and may never achieve marketing approval in any other countries.
Regulatory authorities may change views and recommendations, which could lead to more challenging regulatory paths to approvals and to more expensive clinical and commercial efforts.
Even with the commercialization of KOSTAIVE in Japan, there might not be meaningful sales in Japan. Despite the approval of KOSTAIVE in Europe, KOSTAIVE has not, and might never, achieve commercialization in Europe.
There is significant competition in the development of a vaccine against COVID-19, some competitors’ vaccines are already widely accepted in the market, and many of our competitors have substantially greater financial, scientific and other resources than we have.
If we are unable to generate successful results from preclinical and clinical studies of our product candidates, or experience significant delays in doing so, our business may be materially harmed.
Our platform focuses on nucleic acid technology, and mRNA drug products in particular, which are relatively new and any adverse results from nucleic acid or mRNA technologies in the industry could significantly impact our ability to develop and commercialize marketable products.
The other 59 risks
Changes to our drug product format could significantly impact our timeline to commercialize our products.
We may not be successful in our efforts to identify or discover potential product candidates.
We may find it difficult to identify and enroll patients in our clinical studies, and the limited number of patients who have the diseases for which certain of our product candidates are being studied could delay or prevent clinical studies of certain of our product candidates.
If any of our product candidates cause undesirable side effects or have other properties impacting safety, further clinical trials may be denied or delayed and regulatory approval could be prevented, delayed or limited.
Even if we obtain regulatory approval for a product candidate, we will still face extensive regulatory requirements and our products may face future development and regulatory difficulties.
If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
Manufacturing issues may arise that could increase product and regulatory approval costs or delay or hinder commercialization.
The commercial success of our product candidates will depend in part upon the acceptance of our product candidates by the medical community, including physicians, patients and healthcare payors.
If our strategic alliances are unsuccessful or are terminated, we may be unable to commercialize certain product candidates and generate revenues.
CSL Limited’s recent financial report included a significant write-down related to our licensed assets; a potential separation of CSL Seqirus could disrupt our collaboration and materially harm our business.
If the contract manufacturers we rely on to produce the supply of our preclinical and clinical product candidates, including materials for the manufacture of our product candidates, do not timely deliver adequate quantities of quality materials, development and commercialization of our product candidates would be hindered.
Any disruption in the supply chain of raw materials for, or in the manufacturing capacity and timing for the manufacture of drug substance or drug product for, our product candidates may cause a delay in
developing and commercializing these product candidates and limit the revenues that we could generate.
If the contract research organizations and clinical trial sites we rely on to conduct, supervise and monitor our clinical trials perform in an unsatisfactory manner, it may harm our business.
If we are unable to obtain or protect intellectual property rights related to our products and product candidates, we may not be able to compete effectively in our markets.
Claims that we infringe the intellectual property rights of others, especially in the crowded and competitive field of mRNA patents, may prevent or delay our development and commercialization efforts.
If we fail to obtain licenses to necessary intellectual property or do not comply with our obligations in license agreements, we could lose important rights.
We may be involved in lawsuits to protect or enforce our patents or to defend against third party intellectual property claims, which could be expensive, time consuming and unsuccessful.
We have filed a lawsuit alleging trade secret misappropriation and breach of contract, and any unfavorable outcome or related proceedings could materially and adversely affect our business, financial condition, results of operations, and reputation.
U.S. Government agencies have special contracting authority that gives them the ability to terminate and/or modify their contracts with us.
RISKS RELATED TO OUR FINANCIAL CONDITION AND NEED FOR ADDITIONAL CAPITAL
Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
RISKS RELATED TO THE DEVELOPMENT AND COMMERCIALIZATION OF PRODUCT CANDIDATES
A potential separation of CSL Seqirus could disrupt our collaboration and materially harm our business.
There is significant competition in the COVID-19 vaccine market, some competitors’ vaccines are already widely accepted in the market, and many of our competitors have substantially greater financial, scientific and other resources than we have.
We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
Changes to our drug product presentation could significantly impact our timeline to commercialize our products.
If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
If any of our product candidates cause undesirable side effects or have other properties impacting safety, approvals to proceed with further clinical trials may be denied or delayed and regulatory approval could be prevented, delayed or limited.
Even if we complete the necessary preclinical studies and clinical trials, we are required to obtain regulatory approval to commercialize a product candidate and we cannot, therefore, predict the timing of any revenue from a future product.
Our rare disease candidates, even if approved, might not have a profitable commercial market.
Current regulatory authorities in the United States may change or institute policies that increase challenges for clinical development, regulatory approval and commercialization of our vaccine and other programs
We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
If we are unable to establish cost-effective sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenues from product sales.
KOSTAIVE has received marketing approval in Japan and Europe, and might in the future receive approvals in other countries outside of the United States. A variety of risks associated with international operations could materially adversely affect our business.
Tariffs could adversely affect our business and financial results.
If coverage and adequate reimbursement is not available for any of our future products, it would be difficult for us to sell that product profitably.
RISKS RELATED TO OUR RELIANCE ON OUTSIDE PARTIES
If the outside contractors we rely on to conduct some aspects of our compound formulation, research and studies do not perform satisfactorily and meet deadlines, development of our product candidates could be delayed or precluded.
If the contract manufacturers we rely on to produce the supply of our preclinical and clinical product candidates, including materials for the manufacture of our product candidates do not timely deliver adequate quantities of quality materials, development and commercialization of our product candidates would be hindered.
Any disruption in the supply chain of raw materials for, or in the manufacturing capacity and timing for the manufacture of drug substance or drug product for, our product candidates may cause a delay in developing and commercializing these product candidates and limit the revenues that we could generate.
RISKS RELATED TO OUR INTELLECTUAL PROPERTY
Claims that we infringe the intellectual property rights of others, especially in the crowded and competitive field of mRNA and delivery technology patents, may prevent or delay our development and commercialization efforts.
We may be involved in lawsuits to protect or enforce our patents or the patents of our licensees, which could be expensive, time consuming and unsuccessful.
If we are subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties, we could incur substantial expenses.
Certain of our patents are, and our future owned and in-licensed patents may be, discovered through government funded programs and thus may subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies, and the exercise of such “march-in” rights by the U.S. government could harm our business, financial conditions, results of operations and prospects.
RISKS RELATED TO OUR BUSINESS OPERATIONS AND INDUSTRY
We may need to expand our organization and may experience difficulties in managing this growth, which could disrupt our operations.
If we cannot continue to attract, retain and motivate key executives and qualified scientists and other personnel, we will not be able to effectively operate our business.
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
If we do not fully comply with applicable healthcare fraud and abuse laws, false claims laws and health information privacy and security laws, we could face criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
Recent and future healthcare legislation may further impact our business operations.
We face potential product liability, and, if successful claims are brought against us, we may incur substantial liability and costs.
Cyber security risks and the failure to maintain the confidentiality, integrity, and availability of our computer hardware, software, and Internet applications and related tools and functions could result in damage to our reputation and/or subject us to costs, fines or lawsuits.
Our use of artificial intelligence technologies may expose us to operational, cybersecurity, legal and reputational risks.
Business interruptions could delay us in the process of developing our future products.
A prolonged U.S. federal government shutdown could materially and adversely affect our business, operations, and legal proceedings.
RISKS RELATED TO OUR COMMON STOCK
We do not intend to pay dividends on our common stock so any returns to investors will be limited to the value of our shares.
The market price of our common stock has been, and is expected to continue to be, highly volatile and investors may not be able to resell shares at or above the price at which they purchased the shares.
The requirements of being a publicly traded company may strain our resources and divert management’s attention.
If we are subject to securities class action litigation, we would incur substantial costs and diversion of management’s attention.
Sales of a substantial number of shares of our common stock in the public market by our existing shareholders could cause our share price to fall.
Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall.
We may be unable to comply with the applicable continued listing requirements of Nasdaq.
Legal proceedings
From time to time, we may be involved in various legal proceedings and subject to claims that arise in the ordinary course of business, and the results of litigation and claims are inherently unpredictable and uncertain. Other than as set forth below, we are not currently a party to any material legal proceedings.
On September 23, 2025, we filed a lawsuit against AbbVie Inc., Capstan Therapeutics, Inc. and other defendants in the United States District Court for the Southern District of California, asserting claims for trade secret misappropriation and breach of contract. The defendants filed a motion to discuss the complaint in December 2025, and we filed an opposition to that motion in January 2026. The Court has not set a case schedule.
On May 30, 2025, we initiated an arbitration against CSL Seqirus before the International Chamber of Commerce, seeking payment of a milestone under the CSL Collaboration Agreement based on the European Commission’s grant of marketing authorization for a presentation of KOSTAIVE® in the European Union. On July 25, 2025, CSL Seqirus submitted an Answer in the arbitration contending that it does not have a current obligation to pay the milestone. The arbitration is ongoing with a hearing scheduled to occur in the third quarter of 2026.
