What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-12 compared with 2025-08-11 · 95 added, 82 removed, 232 unchanged (43% of the section changed)

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The following is a discussion of the financial condition and results of operations of Arcturus Therapeutics Holdings Inc.

for the three- and six-month periods ended June 30, 2025.

for the three- and nine-month periods ended September 30, 2025.

Unless otherwise specified herein, references to the “Company,” “Arcturus,” “we,” “our” and “us” mean Arcturus Therapeutics Holdings Inc.

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We have extensive expertise in the design and optimization of mRNA constructs, including with respect to a type of mRNA technology known as self-amplifying mRNA (sa-mRNA).

Our proprietary self-amplifying mRNA technology platform, or STARR ® (“STARR”), has been demonstrated to induce a longer-lasting and broader humoral immune response at lower dose levels than conventional mRNA-based vaccines.

Our proprietary LNP delivery system, LUNAR ® (“LUNAR”), is intended to address the major hurdle in RNA drug development, namely the effective and safe delivery of RNA therapeutics to disease-relevant target tissues.

Our proprietary self-amplifying mRNA technology platform, or STARR ® (“STARR”), has been demonstrated to induce a robust, longer-lasting and broader humoral immune response at lower dose levels than conventional mRNA-based vaccines.

Our proprietary LNP delivery system, LUNAR ® (“LUNAR”), is intended to address the major hurdle in RNA drug development, namely the effective and safe delivery of RNA to disease-relevant target tissues.

LUNAR may enable multiple nucleic acid medicines.

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We may use KOSTAIVE or the specific internally generated name, such as ARCT-154, to identify the vaccine.

In January 2025, CSL Seqirus’ partner Meiji announced that it received approval for a partial amendment to the manufacturing and marketing approval of KOSTAIVE to include manufacturing sites in Japan.

With this approval, Meiji and ARCALIS, Inc., Arcturus’ manufacturing joint venture in Japan, have been added as manufacturing sites.

As a result, KOSTAIVE, with active pharmaceutical ingredients manufactured at such sites, may be shipped for commercial use in Japan.

Meiji has launched in Japan the two-dose vial of KOSTAIVE updated for the JN.1 variant XEC following receipt of approval, in August 2025, from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Approval of KOSTAIVE (ARCT-154) in Europe

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The approval of KOSTAIVE in Europe, as well as the approval in Japan, are significant milestones, which further validate our LUNAR and STARR platforms, as well as sa-mRNA more generally as a meaningful modality.

KOSTAIVE BLA Submission

On September 5, 2025, the week prior to the planned Biologics License Application (“BLA”) submission related to KOSTAIVE, the U.S.

Food and Drug Administration (the “FDA”) requested that the Company delay its submission of the BLA filing based on the FDA’s expectation of providing additional advice.

On October 14, 2025, the FDA informed the Company that, although the FDA had previously agreed that the Company’s proposed data package could support a single-dose indication, upon further consideration it finds that additional data from a clinical endpoint efficacy study will be needed to align with the current COVID-19 vaccine regulatory framework requirements published in The New England Journal of Medicine in May 2025.

The Company and CSL Seqirus are evaluating the new requirements.

Marketing Authorization Application filing of KOSTAIVE in United Kingdom

In June 2025, CSL Seqirus submitted a marketing authorization application (“MAA”) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for KOSTAIVE.

Although there can be no assurances, approval of the MAA is expected in the first quarter of 2026.

Clinical Studies of KOSTAIVE (COVID-19 vaccine)

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Recent KOSTAIVE Publications

In April 2025, we published a comprehensive analysis of safety data for KOSTAIVE ® , with a 12-month follow-up from the pivotal clinical study in Vietnam (NCT05012943), which had 17,582 participants who received at least one dose of the study vaccine (https://doi.org/10.1080/14760584.2025.2487542).

The study confirmed the favorable reactogenicity profile of the vaccine.

Acceptable tolerability of KOSTAIVE (ARCT-154) was also observed in older participants and individuals who are at risk of severe consequences of COVID-19 due to underlying medical conditions.

Long-term follow-up has not revealed any safety concerns, with no reports of myocarditis or pericarditis.

No serious consequences occurred in several pregnancies reported after vaccination.

Long-term data from this large trial suggest that the KOSTAIVE is safe and well-tolerated.

In April 2025, our Japanese partner, Meiji, published an analysis characterizing the distribution and clearance of KOSTAIVE (ARCT-154) encoded spike protein and non-structural proteins nsP1, nsP2, nsP3 and nsP4 in the lymph nodes and injection-site muscle in mice following a single vaccination.

The study showed the encoded spike protein reached its highest level approximately three days after vaccination and quickly disappeared from the injection site muscle.

The spike protein levels also peaked at an early time point in the lymph nodes, it remained detectable 28 days after the vaccination and disappeared by 44 days after the vaccination.

Expression of nsP1, nsP2 and nsP4 was observed in the injected muscle and/or the lymph nodes for up to 15 days post-vaccination.

The data indicates that the extended expression of spike proteins in lymph nodes may be responsible for the induction of higher and prolonged levels of neutralizing antibodies.

The study also confirmed that the self-replication is limited over time.

In July 2025, we published the manuscript ‘Immunogenicity of ARCT-154, a self-amplifying mRNA COVID-19 vaccine, in different booster settings’ ( https://doi.org/10.1016/j.jvacx.2025.100693 ) where we summarized extensive clinical data and concluded that KOSTAIVE (ARCT-154), administered as a homologous or heterologous booster after previous COVID-19 vaccination or natural exposure, provides robust, broad and durable immune responses against SARS-CoV-2 viruses.

In July 2025, a researcher from Tokyo University, Japan, published the manuscript ‘A second-generation, self-amplifying COVID-19 Vaccine:

World’s first approval and distribution in the Japanese market with vaccine hesitancy’ ( https://doi.org/10.1080/21645515.2025.2530291 ).

The manuscript positions KOSTAIVE as a second-generation mRNA vaccine, differentiating it based on effective dose, durability, and breadth of immune response, and summarizes experience from the first year of routine use of the vaccine in Japan.

The manuscript positions KOSTAIVE as a second-generation mRNA vaccine, differentiating it based on effective dose, durability, and breadth of immune response.

It also summarizes the experience from the first year of routine use of the vaccine in Japan.

In August 2025, the manuscript ‘Immunogenicity and Safety of Self-Amplifying mRNA COVID-19 Vaccine (ARCT-2303), With or Without Co-Administration of Seasonal Inactivated Influenza Vaccine in Adults:

a Phase 3, Randomised, Controlled, Observer-blind, Multicentre Study’ was accepted by eClinicalMedicine.

a Phase 3, Randomised, Controlled, Observer-blind, Multicentre Study’ (https://doi.org/10.1016/j.eclinm.2025.103428) was published in eClinicalMedicine.

The manuscript includes the results of the recent pivotal Phase 3 clinical study and concludes that KOSTAIVE (ARCT-2303;

XBB.1.5 strain) induces a robust immune response against the vaccine variant of SARS-CoV-2 and can be co-administered with licensed influenza vaccines in adults with no impact on the safety or immunogenicity of either vaccine.

In August 2025, our Japanese partner, Meiji, announced that it has received manufacturing and marketing approval in Japan for a new presentation of KOSTAIVE ® against COVID-19.

The product targets the SARS-CoV-2 Omicron sub lineage JN.1 variant XEC.

In non-clinical studies, it induced neutralizing antibodies not only against Omicron JN.1 and XEC, but also against LP.8.1 and the currently circulating variants XFG and NB.1.8.1.

The formulation is supplied as a two-dose vial, with one vial per carton.

Seasonal Influenza Program Updates

Under our collaboration with CSL Seqirus, we conducted a Phase 1 study of ARCT-2138, a sa-mRNA seasonal influenza vaccine candidate encoding haemagglutinin (HA) and neuraminidase (NA) of four seasonal influenza strains as recommended by the World Health Organization (WHO).

World Health Organization (WHO).

The study objectives were to evaluate the safety and tolerability and to describe the immune response of different dose levels of the vaccine in 100 young adults (18-49 years of age) and 35 older adults (≥65 years of age).

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In both age categories, HA- and NA-specific antibodies demonstrated a good persistence profile within 6 months post-vaccination.

ARCT-2138 was associated with a dose-dependent increase in the number of activated CD4+ T-cells, more prominent in the higher dose groups.

Most CD4 T-cells induced by the ARCT-2138 vaccine produced cytokines important for an antiviral response.

The higher vaccine doses kept elevated levels of flu-specific CD4 T-cells through Day 91, outperforming two licensed influenza vaccines.

There is also a signal of potential CD8+ activation, as the number of HA- and NA-specific CD8+ T-cells increased after vaccination, indicating the induction of an anti-viral cytotoxic T cell response by the vaccine.

In younger and older adults, the higher dose levels (12 μg and 20 μg) of ARCT-2138 tended to be more reactogenic than the comparator licensed influenza vaccines.

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Pandemic Avian Influenza Program (H5N1 Influenza) Updates

Our LUNAR-H5N1 program, which is part of the CSL Collaboration Agreement, continues to progress under the award from BARDA that we obtained in 2022 to advance through Phase 1 a vaccine to protect against disease caused by H5N1 highly-pathogenic avian influenza.

The Phase 1 study of ARCT-2304, an sa-mRNA vaccine candidate, also known as LUNAR-H5N1, initiated dosing in December 2024 and continues to advance.

We recently completed the recruitment of 212 adults (132 participants 18-59 years old;

80 participants 60+ years old) for the randomized placebo-controlled Phase 1 trial (NCT06602531), which is being conducted at multiple sites in the U.S.

The primary objective of this initial clinical trial is to evaluate the safety and immune responses of three different dose levels and two different vaccination schedules of the ARCT-2304 vaccine.

Immune responses are measured by hemagglutination inhibition (HAI), virus microneutralization (MN) and neuraminidase enzyme-linked lectin assays (ELLA).

The recruitment in this study was completed in April 2025.

In April 2025, the U.S.

Food and Drug Administration (“FDA”) granted Fast Track Designation for ARCT-2304.

Our LUNAR-H5N1 program, which is part of the CSL Collaboration Agreement, continues to progress under the award from BARDA that we obtained in 2022 to advance a candidate vaccine to protect adults against disease caused by H5N1 highly pathogenic avian influenza.

The BARDA funds the development program from the preclinical stage through Phase 1.

In April 2025, the FDA granted Fast Track Designation for ARCT-2304.

This designation recognizes the potential of ARCT-2304 as an innovative approach to address unmet medical needs for the prevention of disease caused by pandemic influenza A virus H5N1, a significant global health risk.

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The designation is designed to expedite the development and review process, providing several benefits, including enhanced communication with the FDA, eligibility for priority review, and the possibility of a rolling review.

Our Phase 1 study of ARCT-2304, an sa-mRNA pandemic influenza A/H5N1 vaccine candidate, released interim results in September 2025.

The study objectives were to evaluate the safety and tolerability and to describe the immune response of three different dose levels in 132 young adults (18-59 years of age) and 80 older adults (60-80 years old).

ARCT-2304 induced a humoral immune response after a single dose (as measured by microneutralization and enzyme-linked lectin anti-neuraminidase assays) in all tested dose levels.

The administration of a second dose of ARCT-2304 further increases immune responses.

The magnitude of anti-HA response was higher after an 8-week interval compared to a 4-week interval in both young and older adults.

ARCT-2304 in dose levels 5 and 12 µg (2 doses administered 4 or 8 weeks apart) and 1.5 µg (2 doses administered 8 weeks apart) induces a hemagglutinin-specific immune response similar to or higher than that after the MF59-adjuvanted pandemic vaccine (in both young and older adults).

No safety or tolerability concerns were raised from available data.

Key Updates on Arcturus-Owned mRNA Therapeutic Development Candidates

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Thirty-two healthy participants (eight subjects in each of four dose cohorts) received a single inhaled dose of ARCT-032 or placebo.

We then amended the protocol to conduct a safety and tolerability Phase 1b clinical study of ARCT-032 in adults with CF and

completed dosing and follow-up visits for seven CF participants in August 2024, with each participant having received two administrations of ARCT-032 separated by two days.

then amended the protocol to conduct a safety and tolerability Phase 1b clinical study of ARCT-032 in adults with CF and completed dosing and follow-up visits for seven CF participants in August 2024, with each participant having received two administrations of ARCT-032 separated by two days.

IND including the ongoing Phase 2 protocol was allowed to proceed in August 2024.

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Each participant in the Phase 2 CF study (NCT06747858) receives daily inhaled treatments of ARCT-032 for 28 days, with dose escalation expected to occur following safety reviews of the data.

On October 21, 2025, we announced interim results from the ongoing Phase 2 clinical trial of ARCT-032 for CF.

In the second cohort of the study, six Class I CF adults received inhaled 10 mg doses of ARCT-032 daily over 28 days.

High-resolution computed tomography (HRCT) lung scans analyzed using FDA 501(k)-cleared AI technology, revealed reductions in mucus burden in four of six Class I CF participants.

The treatment was generally safe and well tolerated.

Treatment related AEs that were identified in the single-dose Phase 1 study were also observed in some participants for the first few doses but ceased with continued dosing.

One SAE occurred in a participant well after the end of the dosing period.

The Data Monitoring Committee found no convincing evidence that the SAE is related to ARCT-032 and approved the study to proceed.

The third cohort is ongoing and aims to enroll up to six subjects to determine if there is a dose escalation response at 15 mg daily over 28 days and if ARCT-032 continues to be generally safe and well tolerated.

• LUNAR-OTC/ARCT-810 .

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A Linear Mixed-Effects Model (LMM) was applied as an exploratory analysis to the Phase 2 glutamine and ureagenesis data.

LMM is suitable for small-N analyses, i.e.

rare disease trial datasets.

LMM is suitable for analyses of small rare disease trial datasets.

In the Phase 2 randomized European study, glutamine levels in patients who received multiple doses of ARCT-810 significantly (p-value = 0.016;

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21.7%) at 28 days post-fifth dose.

These results suggest a progressive increase of functional OTC enzyme in the liver with continued administrations.

These results suggest a progressive increase of functional OTC enzyme in the liver with continued administrations of ARCT-810.

Two of the three participants achieved RUF > 50% indicating a clinically meaningful improvement in urea cycle flux.

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up to 6 infusions) in the Phase 2 protocols.

Arcturus continues to advance the ARCT-810 program for OTC deficiency.

Results of Operations

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The following table summarizes our total revenues for the periods indicated:

Three Months Ended June 30,

Three Months Ended September 30,

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Revenue decreased by $21.6 million during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024.

The decrease was due to reduced revenue related to the CSL collaboration, caused by less revenue from supply agreements and less amortization as KOSTAIVE transitions from a development program to the commercial phase.

Six Months Ended June 30,

Revenue decreased by $24.5 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024.

The decrease was primarily attributable to lower revenue recognized under the CSL collaboration, driven by reduced revenue from supply agreements and less amortization of deferred revenue as KOSTAIVE transitions from a development program to the commercial phase.

Nine Months Ended September 30,

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Revenue decreased by $30.2 million during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024.

The decrease was primarily attributable to a $28.4 million reduction in revenue related to the CSL collaboration during the current period, caused by less revenue from supply agreements and less amortization as KOSTAIVE transitions from a development program to the commercial phase.

Revenue decreased by $54.7 million during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024.

The decrease was primarily attributable to lower revenue recognized under the CSL collaboration during the current period, driven by reduced revenue from supply agreements and less amortization of deferred revenue as KOSTAIVE transitions from a development program to the commercial phase.

The remaining decrease was primarily attributable to a decrease in grant revenue.

Operating Expense

Our operating expenses consist of research and development and general and administrative expenses.

Three Months Ended June 30,

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The following table presents our total research and development expenses by category:

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Total research and development expenses, net

* Greater than 100%

Our research and development expenses consist primarily of external manufacturing costs, in-vivo research studies and clinical trials performed by contract research organizations, clinical and regulatory consultants, personnel related expenses, facility related expenses and laboratory supplies related to conducting research and development activities.

Research and development expenses were $29.6 million for the three months ended June 30, 2025, compared with $58.7 million for the three months ended June 30, 2024.

The decrease was primarily driven by lower manufacturing costs related to the LUNAR-COVID, LUNAR-FLU, and LUNAR-CF programs, as well as reduced clinical trial expenses associated with the LUNAR-COVID and LUNAR-OTC programs.

Research and development expenses were $23.3 million for the three months ended September 30, 2025, compared with $39.1 million for the three months ended September 30, 2024.

The decrease was primarily driven by lower manufacturing costs related to the LUNAR-COVID, LUNAR-FLU, and LUNAR-CF, as well as reduced clinical trial expenses associated with the LUNAR-COVID and LUNAR-CF programs.

Additional decreases were attributable to lower payroll and benefits costs.

These reductions were partially offset by increased clinical costs related to the LUNAR-CF program as we began Phase II clinical trials in fiscal year 2025.

Research and development expenses were $64.5 million for the six months ended June 30, 2025, compared with $112.2 million for the six months ended June 30, 2024.

These reductions were partially offset by increased facilities and equipment costs, driven by the absence of the prior year lease impairment reversal.

Research and development expenses were $87.7 million for the nine months ended September 30, 2025, compared with $151.4 million for the nine months ended September 30, 2024.

The decrease was primarily driven by lower manufacturing and clinical costs related to the LUNAR-COVID program, reflecting the program’s transition from a development program to the commercial phase.

decreases were attributable to lower payroll and benefits expenses, as well as reduced facilities and equipment costs as we downsized from three to two facilities.

These reductions were partially offset by increased clinical costs related to the LUNAR-CF program.

Additional decreases were attributable to lower manufacturing costs for the LUNAR-CF and LUNAR-FLU programs.

These reductions were partially offset by higher clinical costs for Phase 2 of the LUNAR-CF program.

Payroll and benefits expenses also decreased, primarily due to lower stock-based compensation expense.

Early-stage programs represent programs that are in the pre-clinical or Phase 1 clinical stage and may be partnered or unpartnered, and primarily includes the LUNAR-FLU program which is partnered with CSL Seqirus.

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A few of our programs are part of our collaborative relationships.

The related expenses may be partially offset with funds that have been reimbursed or awarded to the Company and consist of external manufacturing costs, lab supplies, equipment, and consulting and professional fees.

The related expenses may be partially offset with funds that have been reimbursed or awarded to us and consist of external manufacturing costs, lab supplies, equipment, and consulting and professional fees.

Expenses for both early-stage programs and discovery technologies are expected to decrease as we shift our focus to later-stage programs.

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Facilities and equipment expenses include rent, common area maintenance (“CAM”) costs, depreciation, shipping costs and various other costs related to the operation of our two office and laboratory locations.

These costs decreased during the first six months of 2025 as compared to the first six months of 2024, as we downsized from three to two facilities.

Facilities and equipment expenses are not expected to increase during the next twelve months.

These costs decreased during the first nine months of 2025 as compared to the first nine months of 2024, as we downsized from three to two facilities.

Facilities and equipment expenses are not expected to increase during the next twelve months compared to expense levels recognized in the third quarter of 2025.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related benefits for our executive, administrative and accounting functions and professional service fees for legal and accounting services as well as other general and administrative expenses.

General and administrative expenses were $10.3 million for the three months ended June 30, 2025, compared with $12.3 million for the three months ended June 30, 2024.

General and administrative expenses were $21.7 million for the six months ended June 30, 2025, compared with $27.2 million for the six months ended June 30, 2024.

The decreases in both periods were primarily due to reduced share-based compensation expense as well as reduced payroll and benefits.

General and administrative expenses were $10.4 million for the three months ended September 30, 2025, compared with $13.3 million for the three months ended September 30, 2024.

General and administrative expenses were $32.1 million for the nine months ended September 30, 2025, compared with $40.4 million for the nine months ended September 30, 2024.

The decreases in both periods were primarily due to reduced share-based compensation expense as well as reduced payroll and benefits associated with reductions in headcount.

Finance income, net

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Interest income is generated on the Company’s cash and cash equivalents.

The decrease in interest income for the three and six months ended June 30, 2025, compared to the same periods in 2024, was primarily due to lower interest rates and a reduced cash balance.

The decrease in interest income for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was primarily due to lower interest rates and a reduced cash balance.

Off-balance sheet arrangements

Through June 30, 2025, we have not entered into and did not have any relationships with unconsolidated entities or financial collaborations, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

Through September 30, 2025, we have not entered into and did not have any relationships with unconsolidated entities or financial collaborations, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

Liquidity and Capital Resources

From the Company’s inception through the quarter ended June 30, 2025, the Company has funded its operations principally with the proceeds from revenues earned through collaboration agreements and government contracts, the sale of capital stock and long-term debt.

Through the second quarter of 2025, we have achieved a total of approximately $509.7 million in upfront payments and milestones from CSL Seqirus, including milestones of $20.0 million achieved in the current quarter.

From the Company’s inception through the quarter ended September 30, 2025, the Company has funded its operations principally with the proceeds from revenues earned through collaboration agreements and government contracts, the sale of capital stock and long-term debt.

Through the third quarter of 2025, we have achieved a total of approximately $513.8 million in upfront payments and milestones from CSL Seqirus, including $4.1 million in upfront payments during the current quarter.

We expect to receive future payments from CSL Seqirus primarily by meeting future milestones related to the CSL Collaboration Agreement.

As of June 30, 2025, the Company’s balance of cash and cash equivalents, including restricted cash, was $253.4 million.

As of September 30, 2025, the Company’s balance of cash and cash equivalents, including restricted cash, was $237.2 million.

CSL Seqirus, Inc.

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We received an up-front payment of $200.0 million during the fourth quarter of 2022.

We will be eligible to receive development milestones totaling more than $1.3 billion if all products

are registered in the licensed fields.

We will be eligible to receive development milestones totaling more than $1.3 billion if all products are registered in the licensed fields.

We will also be entitled to receive up to $3.0 billion in commercial milestones based on “net sales” of vaccines in the various fields.

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As collateral, the Company has agreed to pledge $55.0 million in cash to be held at our securities accounts with Wells Fargo Securities, LLC, an affiliate of Wells Fargo, pursuant to a security agreement.

In June 2024, Arcturus Therapeutics and Wells Fargo entered into an amendment to the Note, whereby the term of the Note was extended by one year to April 2026.

No amounts were drawn down under the Loan during the three months period ended September 30, 2025.

Grant from the Biomedical Advanced Research and Development Authority

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The BARDA Contract is to support our non-clinical and pre-clinical development, early-stage clinical development through Phase 1, and associated drug product manufacturing, regulatory and quality-assurance activities over a period of three years.

It provides for reimbursement by BARDA of our permitted costs up to $63.2 million.

As of June 30, 2025, the remaining available funding net of revenue earned was $32.2 million.

It provides for reimbursement by BARDA of

our permitted costs up to $63.2 million.

As of September 30, 2025, the remaining available funding net of revenue earned was $30.3 million.

Vinbiocare Agreement

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Vinbiocare is also eligible to receive a single digit percentage of amounts received by Arcturus on net sales, if any, of ARCT-154 (or next-generation COVID vaccine) up to a capped amount.

As of September 30, 2025, the Vinbiocare contractual liabilities in accrued expenses was $0.4 million.

General Financial Resources

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Our future capital requirements are difficult to forecast and will depend on many factors that are out of our control.

If we are unable to maintain sufficient financial resources, our business, financial condition and results of operations will be materially and

adversely affected.

If we are unable to maintain sufficient financial resources, our business, financial condition and results of operations will be materially and adversely affected.

There can be no assurance that we will be able to obtain additional needed financing on acceptable terms or at all.

Additionally, equity or debt financings may have a dilutive effect on the holdings of our existing shareholders.

We expect to continue to incur additional losses in the long term, and we will need to execute on the remaining milestones within the CSL Collaboration Agreement, raise additional debt or equity financing or enter into additional partnerships to fund development.

We expect to continue to incur additional losses in the long term, and we will need to execute on the additional milestones within the CSL Collaboration Agreement, raise additional debt or equity financing or enter into additional partnerships to fund development.

Our ability to transition to profitability is dependent on regulatory approvals and subsequent sales of KOSTAIVE, executing on milestones within the CSL Collaboration Agreement and identifying and developing other successful mRNA drug and vaccine candidates.

If we are not able to achieve planned milestones or incur costs in excess of our forecasts, we will need to reduce discretionary spending, discontinue the development of some or all of our programs, which will delay part of our development programs, all of which will have a material adverse effect on our ability to achieve our intended business objectives.

The following table shows a summary of our cash flows for the six months ended June 30, 2025 and 2024:

Six Months Ended June 30,

The following table shows a summary of our cash flows for the nine months ended September 30, 2025 and 2024:

Nine Months Ended September 30,

(in thousands)

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Operating Activities

Net cash used in operating activities was $40.9 million for the six months ended June 30, 2025, compared to $35.7 million for the six months ended June 30, 2024.

The increase in cash outflows was primarily driven by working capital changes, including a total decrease of $22.1 million in accrued liabilities and accounts payable due to increased vendor payments during the period.

These impacts were partially offset by a $14.1 million improvement in net loss after non-cash adjustments and a $4.2 million cash inflow related to changes in prepaid and other current assets.

Net cash used in operating activities was $58.0 million for the nine months ended September 30, 2025, compared to $59.5 million for the nine months ended September 30, 2024.

The increase in cash outflows was primarily driven by higher payments of accrued liabilities, partially offset by the timing of payments received under collaboration agreements and reductions in prepaid balances.

Investing Activities

Net cash used in investing activities of $0.1 million for the six months ended June 30, 2025, and $0.6 million for the six months ended June 30, 2024, reflected the acquisition of property and equipment.

Net cash used in investing activities was $0.3 million for the nine months ended September 30, 2025, compared with $0.7 million for the nine months ended September 30, 2024.

Activity in both periods primarily reflected purchases of property and equipment.

Financing Activities

Net cash provided by financing activities was $0.5 million for the six months ended June 30, 2025, compared to $4.6 million for the six months ended June 30, 2024.

The decrease was primarily driven by reduced stock option exercise activity in 2025.

Net cash provided by financing activities was $1.7 million for the nine months ended September 30, 2025, compared to $5.3 million for the nine months ended September 30, 2024.

The decrease in cash inflow was primarily driven by reduced stock option exercise activity in 2025.

Funding Requirements

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These judgments involve making estimates about the effect of matters that are inherently uncertain and may significantly impact our reported results of operations and financial condition.

We describe our significant accounting policies more fully in Note 2 to our consolidated financial statements for the year ended December 31, 2024.

We describe our significant accounting policies more fully in Note 2 to our consolidated financial statements for the year ended December 31, 2024 included in the 2024 Annual Report.

There have been no material changes to our critical accounting policies and estimates from the information provided in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, included in the 2024 Annual Report.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis