cs UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share ARCT The NASDAQ Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ...

[Executive Summary & Recent Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Highlights) Arcturus Therapeutics reported Q1 2024 financial results and significant pipeline advancements, including Kostaive® commercialization, positive Phase 3 data, new study initiations, and strategic financial updates [Q1 2024 Overview](index=1&type=section&id=Q1%202024%20Overview) Arcturus Therapeutics announced its financial results for the first quarter ended March 31, 2024, alongside significant pipeline advancements across its vaccine and therapeutic programs, and strategic corporate updates - Commercial manufacture of Kostaive® is on track for delivery of initial **4 million doses** in Q3[1](index=1&type=chunk) - Kostaive® European Marketing Authorization Application approval decision is expected in Q3[1](index=1&type=chunk) - Topline immunogenicity and safety data for ARCT-2138 (LUNAR-FLU) Phase 1 is anticipated in Q3[1](index=1&type=chunk) - Interim data and updates for ARCT-810 (LUNAR-OTC) Phase 2 and ARCT-032 (LUNAR-CF) Phase 1b will be provided on July 1[1](index=1&type=chunk) - JP Morgan has been engaged to monetize Arcturus' investment in the ARCALIS JV in Japan[1](index=1&type=chunk) [Recent Corporate Highlights](index=1&type=section&id=Recent%20Corporate%20Highlights) The company provided detailed updates on its vaccine and therapeutic pipeline, including progress on Kostaive® commercialization, positive Phase 3 results for ARCT-2301, initiation of new Phase 3 studies, and advancements in its rare disease programs, alongside strategic financial initiatives - Meiji Seika Pharma announced plans to supply Japan with **4 million doses** of Kostaive® for the fall/winter season of 2024, with Arcturus and CDMO partners on track to deliver initial commercial doses in Q3[2](index=2&type=chunk) - The bivalent COVID-19 Vaccine candidate, ARCT-2301, met the primary endpoint (non-inferiority) in a Phase 3 clinical study in Japan, demonstrating non-inferiority and superiority criteria for neutralizing antibodies against SARS-CoV-2 (Omicron BA.4/5) and Wuhan strains, with no causally-associated serious adverse events[2](index=2&type=chunk)[3](index=3&type=chunk) - A Phase 3 pivotal study was initiated for the ARCT-2303 candidate vaccine (Omicron XBB.1.5 variant) to generate immunogenicity and safety data for U.S. licensure and assess co-administration with seasonal influenza vaccines[3](index=3&type=chunk) - A Marketing Authorization Application (MAA) for Kostaive® has been filed with the European Medicines Agency (EMA), with an approval decision expected in Q3[3](index=3&type=chunk) - ARCT-2138 (LUNAR-FLU, Quadrivalent Seasonal Influenza) Phase 1 dose-finding and immunogenicity study is progressing, with **84 healthy young adults** recruited[3](index=3&type=chunk) - ARCT-810 (LUNAR-OTC) Phase 1 single ascending dose (SAD) studies demonstrated general tolerability with no serious or severe adverse events, facilitating the initiation of a Phase 2 multiple ascending dose study (ARCT-810-03) in OTC deficiency adolescents and adults, with a progress update expected July 1, 2024[3](index=3&type=chunk) - ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis, is on track to share Phase 1b interim data on July 1, 2024[3](index=3&type=chunk) - Arcturus will begin to qualify for commercial milestones under its CSL collaboration upon commencement of Kostaive® revenues in Japan this year[2](index=2&type=chunk) - The company's cash runway remains strong for at least **three years** into the first quarter of fiscal year 2027[2](index=2&type=chunk)[9](index=9&type=chunk) [First Quarter 2024 Financial Results](index=2&type=section&id=First%20Quarter%202024%20Financial%20Results) Arcturus Therapeutics' Q1 2024 financial results show a significant year-over-year revenue decrease, increased operating expenses leading to a net loss, yet maintaining a strong cash position with a multi-year runway [Revenue Analysis](index=2&type=section&id=Revenue%20Analysis) Total revenues for Q1 2024 significantly decreased year-over-year, primarily due to lower revenue recognition from the CSL agreement, partially offset by an increase from the BARDA agreement Revenue Summary (Three Months Ended March 31) | Metric | Q1 2024 ($M) | Q1 2023 ($M) | Change ($M) | Change (%) | | :---------------------- | :----------- | :----------- | :---------- | :--------- | | Total Revenues | 38.0 | 80.3 | (42.3) | (52.7%) | | CSL Agreement Revenue | 32.4 | 78.2 | (45.8) | (58.6%) | | BARDA Agreement Revenue | N/A | N/A | +4.9 (increase) | N/A | [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Total operating expenses saw a slight increase year-over-year, driven by higher research and development costs related to key programs and increased general and administrative expenses Total Operating Expenses (Three Months Ended March 31) | Metric | Q1 2024 ($M) | Q1 2023 ($M) | Change ($M) | Change (%) | | :------------------- | :----------- | :----------- | :---------- | :--------- | | Total Operating Expenses | 68.4 | 65.5 | 2.9 | 4.4% | [Research and Development Expenses](index=3&type=section&id=Research%20and%20Development%20Expenses) R&D expenses increased due to investments in CSL, BARDA, internal OTC, Cystic Fibrosis, and early-stage discovery programs Research and Development Expenses (Three Months Ended March 31) | Metric | Q1 2024 ($M) | Q1 2023 ($M) | Change ($M) | Change (%) | | :------------------- | :----------- | :----------- | :---------- | :--------- | | R&D Expenses | 53.6 | 51.8 | 1.8 | 3.5% | - The increase in R&D expenses was primarily driven by the CSL and BARDA programs, as well as Arcturus' internal OTC and Cystic Fibrosis programs, and investments in early-stage discovery technologies including Lyme Disease and Gonorrhea vaccine programs[6](index=6&type=chunk) [General and Administrative Expenses](index=3&type=section&id=General%20and%20Administrative%20Expenses) G&A expenses rose due to increased personnel, travel, consulting, and facility-related rent expenses General and Administrative Expenses (Three Months Ended March 31) | Metric | Q1 2024 ($M) | Q1 2023 ($M) | Change ($M) | Change (%) | | :------------------- | :----------- | :----------- | :---------- | :--------- | | G&A Expenses | 14.9 | 13.8 | 1.1 | 8.0% | - The increase in G&A expenses resulted primarily from increased personnel expenses due to higher salaries, increased travel and consulting expenses, and escalated rent expense associated with facilities[7](index=7&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) The company reported a net loss in Q1 2024, a significant shift from net income in the prior year, primarily due to lower revenues and increased operating expenses Net (Loss) Income and EPS (Three Months Ended March 31) | Metric | Q1 2024 ($M) | Q1 2023 ($M) | Change ($M) | | :---------------- | :----------- | :----------- | :---------- | | Net (Loss) Income | (26.8) | 50.8 | (77.6) | | Diluted EPS | ($1.00) | $1.87 | ($2.87) | [Cash Position and Balance Sheet Highlights](index=3&type=section&id=Cash%20Position%20and%20Balance%20Sheet%20Highlights) Arcturus maintained a strong cash position at the end of Q1 2024, with a projected cash runway extending into Q1 2027, supported by ongoing CSL milestone payments Cash, Cash Equivalents and Restricted Cash | Metric | March 31, 2024 ($M) | December 31, 2023 ($M) | Change ($M) | | :----------------------------------- | :------------------ | :--------------------- | :---------- | | Cash, cash equivalents and restricted cash | 345.3 | 348.9 | (3.6) | - Arcturus achieved approximately **$420.1 million** in upfront payments and milestones from CSL as of March 31, 2024[9](index=9&type=chunk) - The company expects to continue receiving future milestone payments from CSL supporting the ongoing development of COVID and flu programs and three additional vaccine programs[9](index=9&type=chunk) - The expected cash runway extends at least **three years** based on the current pipeline and programs through the first quarter of fiscal year 2027[9](index=9&type=chunk) [Company Information & Disclosures](index=4&type=section&id=Company%20Information%20%26%20Disclosures) This section provides an overview of Arcturus Therapeutics as a global mRNA company, highlighting its technologies and pipeline, alongside important disclaimers regarding forward-looking statements [About Arcturus Therapeutics](index=4&type=section&id=About%20Arcturus%20Therapeutics) Arcturus Therapeutics is a global mRNA medicines and vaccines company, founded in 2013, known for its LUNAR® lipid-mediated delivery and STARR® mRNA Technology, and for developing the first approved self-amplifying mRNA COVID vaccine (Kostaive®). It has extensive collaborations and a broad pipeline - Arcturus Therapeutics Holdings Inc. is a global mRNA medicines and vaccines company, founded in **2013** and based in San Diego, California[10](index=10&type=chunk) - The company's enabling technologies include LUNAR® lipid-mediated delivery, STARR® mRNA Technology (sa-mRNA), and mRNA drug substance along with drug product manufacturing expertise[10](index=10&type=chunk) - Arcturus developed Kostaive®, the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID vaccine[10](index=10&type=chunk) - The company has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus and a joint venture in Japan, ARCALIS, focused on mRNA vaccine and therapeutic manufacturing[10](index=10&type=chunk) - Arcturus' pipeline includes RNA therapeutic candidates for ornithine transcarbamylase deficiency and cystic fibrosis, as well as partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza[10](index=10&type=chunk) - Arcturus' technologies are covered by an extensive patent portfolio with over **400 patents** and patent applications globally[10](index=10&type=chunk) - The Arcturus logo and trademarks LUNAR® and STARR® are the property of Arcturus[12](index=12&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines the forward-looking nature of statements made in the press release, emphasizing inherent risks and uncertainties that could cause actual results to differ materially from projections, and disclaims any obligation to update such statements - This press release contains forward-looking statements that involve substantial risks and uncertainties, provided for the safe harbor under the Private Securities Litigation Reform Act of 1995[11](index=11&type=chunk) - Forward-looking statements include those regarding strategy, future operations, pipeline success (ARCT-032, ARCT-810), partnered programs (COVID-19, flu with CSL Seqirus), Kostaive delivery and commercialization, European MAA approval, ARCALIS JV monetization, clinical data predictability, timing of clinical study updates, CSL collaboration milestones, cash position, and general business conditions[11](index=11&type=chunk) - Actual results may differ materially from anticipated outcomes due to known and unknown risks, uncertainties, and other factors, including those discussed in Arcturus' most recent Annual Report on Form 10-K and subsequent SEC filings[11](index=11&type=chunk) - Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, unless required by law[11](index=11&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) This section presents the unaudited condensed consolidated balance sheets and statements of operations for Q1 2024, detailing the company's financial position and performance [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Presents the unaudited condensed consolidated balance sheets for Arcturus Therapeutics as of March 31, 2024, and December 31, 2023, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (in thousands) | (in thousands) | March 31, 2024 (unaudited) | December 31, 2023 | | :------------- | :------------------------- | :---------------- | | **Assets** | | | | Cash and cash equivalents | $288,396 | $292,005 | | Restricted cash | $55,000 | $55,000 | | Accounts receivable | $27,057 | $32,064 | | Prepaid expenses and other current assets | $5,335 | $7,521 | | Total current assets | $375,788 | $386,590 | | Property and equipment, net | $11,763 | $12,427 | | Operating lease right-of-use asset, net | $29,413 | $28,500 | | Non-current restricted cash | $1,885 | $1,885 | | Total assets | $418,849 | $429,402 | | **Liabilities** | | | | Accounts payable | $9,144 | $5,279 | | Accrued liabilities | $34,770 | $31,881 | | Deferred revenue (current) | $71,516 | $44,829 | | Total current liabilities | $115,430 | $81,989 | | Deferred revenue, net of current portion | $11,795 | $42,496 | | Operating lease liability, net of current portion | $27,652 | $25,907 | | Other non-current liabilities | — | $497 | | Total liabilities | $154,877 | $150,889 | | **Stockholders' Equity** | | | | Common stock | $27 | $27 | | Additional paid-in capital | $658,628 | $646,352 | | Accumulated deficit | $(394,683) | $(367,866) | | Total stockholders' equity | $263,972 | $278,513 | | Total liabilities and stockholders' equity | $418,849 | $429,402 | [Consolidated Statements of Operations and Comprehensive (Loss) Income](index=7&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20(Loss)%20Income) Presents the unaudited consolidated statements of operations and comprehensive (loss) income for the three months ended March 31, 2024, and 2023, detailing revenues, operating expenses, net income/loss, and earnings per share Consolidated Statements of Operations and Comprehensive (Loss) Income (in thousands, except per share data) | (in thousands, except per share data) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | **Revenue:** | | | | Collaboration revenue | $32,598 | $79,729 | | Grant revenue | $5,414 | $556 | | Total revenue | $38,012 | $80,285 | | **Operating expenses:** | | | | Research and development, net | $53,573 | $51,768 | | General and administrative | $14,851 | $13,762 | | Total operating expenses | $68,424 | $65,530 | | **(Loss) income from operations** | $(30,412) | $14,755 | | Loss from foreign currency | $(53) | $(328) | | Gain on debt extinguishment | — | $33,953 | | Finance income, net | $4,016 | $2,477 | | Net (loss) income before income taxes | $(26,449) | $50,857 | | Provision for income taxes | $368 | $103 | | Net (loss) income | $(26,817) | $50,754 | | **(Loss) earnings per share** | | | | Basic | $(1.00) | $1.91 | | Diluted | $(1.00) | $1.87 | | **Weighted-average shares used in calculation of (loss) earnings per share:** | | | | Basic | 26,879 | 26,555 | | Diluted | 26,879 | 27,149 | | **Comprehensive (loss) income:** | | | | Net (loss) income | $(26,817) | $50,754 | | Comprehensive (loss) income | $(26,817) | $50,754 |

Core Viewpoint - Wall Street anticipates a year-over-year decline in earnings for Arcturus Therapeutics, with a focus on how actual results compare to estimates, which could significantly impact stock price [1] Financial Expectations - Arcturus Therapeutics is expected to report a quarterly loss of $1.17 per share, reflecting a year-over-year change of -233% [2] - Revenues are projected to be $22.12 million, down 72.5% from the same quarter last year [2] Estimate Revisions - The consensus EPS estimate has been revised 109.3% lower in the last 30 days, indicating a bearish sentiment among analysts [2] - The Most Accurate Estimate for Arcturus is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -5.43% [5] Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likely deviation of actual earnings from the consensus estimate, with predictive power being significant for positive readings only [3][4] - Arcturus currently holds a Zacks Rank of 3, making it challenging to predict an earnings beat conclusively [6] Historical Performance - In the last reported quarter, Arcturus was expected to post a loss of $1.69 per share but actually reported a loss of $0.32, resulting in a surprise of +81.07% [7] - Over the past four quarters, the company has beaten consensus EPS estimates two times [7] Conclusion - An earnings beat or miss may not solely dictate stock movement, as other factors can influence investor sentiment [8] - Arcturus Therapeutics does not appear to be a compelling earnings-beat candidate, and investors should consider additional factors before making decisions [8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Transition Period From To Commission File Number 001-38942 ARCTURUS THERAPEUTICS HOLDINGS INC. (Exact name of Registrant as specified in its Charter) Delaware 32-0595345 (State or other ...

Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q4 2023 Earnings Conference Call March 7, 2024 4:30 PM ET Company Participants Neda Safarzadeh - Vice President, Head of Investor Relations, Public Relations & Marketing. Joe Payne - President & Chief Executive Officer Andy Sassine - Chief Financial Officer Pad Chivukula - Chief Scientific Officer & Chief Operating Officer Conference Call Participants Evan Wang - Guggenheim Securities Whitney Ijem - Canaccord Genuity Myles Minter - William Blair Jan Hughes - ...

Arcturus Therapeutics (ARCT) came out with a quarterly loss of $0.32 per share versus the Zacks Consensus Estimate of a loss of $1.69. This compares to earnings of $4.33 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 81.07%. A quarter ago, it was expected that this pharmaceutical company would post a loss of $1.79 per share when it actually produced a loss of $0.61, delivering a surprise of 65.92%.Over the last four quarters, ...

SAN DIEGO--(BUSINESS WIRE)--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced its financial results for the fourth quarter ended December 31, 2023, and provided corporate updates. “I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” sai ...

Revenue Performance - Arcturus reported revenue of $169.9 million for the year ended December 31, 2023, a decrease from $206.0 million in 2022, primarily due to the discontinuation of collaborations with Vinbiocare and Janssen[4] - Revenue from CSL in 2023 was $157.4 million, slightly increasing by $3.0 million compared to 2022[4] - Total revenue for 2023 was $169.933 million, a decrease of 17.5% from $205.999 million in 2022[17] - Collaboration revenue for 2023 was $160.882 million, down from $205.755 million in 2022, representing a decline of 22%[17] Operating Expenses - Total operating expenses for 2023 were $245.0 million, up from $193.8 million in 2022[5] - Research and development expenses increased to $192.1 million in 2023 from $147.8 million in 2022, driven by CSL and BARDA programs[6] - Research and development expenses increased to $192.133 million in 2023, up 30% from $147.751 million in 2022[17] - Operating expenses for the three months ended December 31, 2023, were $49.127 million, compared to $38.841 million for the same period in 2022[19] Net Income and Loss - The net loss for 2023 was approximately $26.6 million, or ($1.00) per diluted share, compared to a net income of $9.3 million, or $0.35 per diluted share in 2022[8] - Net loss for 2023 was $26.591 million, compared to a net income of $9.349 million in 2022[17] - Basic and diluted loss per share for 2023 was $(1.00), compared to earnings of $0.35 per share in 2022[17] - Net loss for the three months ended December 31, 2023, was $8.573 million, compared to a net income of $117.347 million for the same period in 2022[19] Cash and Assets - Cash, cash equivalents, and restricted cash were $348.9 million at December 31, 2023, down from $394.0 million at the end of 2022[9] - Total current assets decreased to $386.590 million as of December 31, 2023, from $403.333 million at the end of 2022[15] - Total liabilities decreased to $147.755 million as of December 31, 2023, from $180.075 million at the end of 2022[15] - Total assets decreased to $429.402 million as of December 31, 2023, from $450.387 million at the end of 2022[15] Future Developments - The cash runway has been extended to Q1 2027 due to disciplined cost management and progress in collaborations[2] - Kostaive® is anticipated to launch in Japan in 2024, marking a significant milestone as the world's first self-amplifying mRNA product approved for COVID-19[3] - ARCT-032 received Orphan Drug Designation from the U.S. FDA and the European Commission, with Phase 1b interim data expected in Q2 2024[2] - New vaccine discovery programs for Lyme Disease and Gonorrhea have been initiated based on the validation of LUNAR® and STARR® technologies[3]

Shares of Arcturus Therapeutics Holdings Inc. (ARCT) have surged 73% in the past three months compared with the industry’s growth of 10.5%.Last month, the European Commission granted orphan medicinal product designation to the company’s product candidate ARCT-032 for the treatment of cystic fibrosis (CF). The designation is likely to support the development of ARCT-032, including certain protocol assistance, access to the centralized authorization procedure, exemption from fees and research funding, along w ...

While biotech stocks offer some of the most pertinent ideas available in the market, they can be awfully risky. One bad clinical result and boom – there goes your hard-earned money in the toilet. To mitigate the downside risks, it may be better to consider undervalued enterprises.Of course, specifically targeting biotech stocks that trade below their intrinsic or perceived value offers no guarantee of success. Still, given the sometimes extreme mobility that the ecosystem facilitates, it may pay to have cal ...