Arcturus Therapeutics (ARCT) closed the last trading session at $21.10, gaining 2.7% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $66.75 indicates a 216.4% upside potential.The average comprises eight short-term price targets ranging from a low of $18 to a high of $140, with a standard deviation of $35.48. While the lowest estimate indicates a decline of 14.7% from the current p ...

Core Viewpoint - Arcturus is positioned for a significant breakthrough with the upcoming commercial launch of its Kostaive self-amplifying mRNA COVID-19 vaccine, supported by strong phase 3 data and a partnership with Meiji for regulatory compliance in Japan [2][6]. Business Developments - The company has consistently generated research revenues, primarily driven by its agreement with CSL, which has allowed it to maintain a balanced cash flow without relying solely on capital raised for product development [3][4]. - In 2Q24, Arcturus achieved key milestones in its CSL agreement, completing manufacturing-related activities for the Kostaive vaccine [3]. Revenue Potential - The Kostaive vaccine is expected to generate significant revenue, with Meiji ordering 4 million doses priced at approximately $68.5 each, potentially leading to $274 million in revenue [6]. - Revenue recognition from the Kostaive vaccine is anticipated in 4Q24, marking a critical milestone for the company [11]. Valuation Insights - Arcturus is currently trading at a price-to-sales (PS) ratio of 3.41, which is lower than several industry peers, suggesting it may be undervalued [7]. - The price-to-book (PB) ratio aligns more closely with its peers, indicating a reasonable valuation in that regard [7]. Revenue Estimates - Projections indicate that Arcturus could earn $347 million in revenues by 2026, with a conservative estimate of $139 million [9]. - The revised valuation model reflects a more conservative approach to revenue estimates, adjusting the sales multiple to align with current market conditions [9]. Conclusion - The second quarter of 2024 showed promising signs for Arcturus, confirming its ability to generate R&D revenues and conserve cash, with the potential for a consistent revenue stream from its first commercial product [11]. - The company’s technology is nearing validation, presenting a compelling long-term investment opportunity despite its higher risk profile compared to more established biotech firms [11].

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 June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to C ...

Arcturus Therapeutics Announces Second Quarter 2024 Financial Update and Pipeline Progress IND submitted for Phase 2 trial of ARCT-032 targeting cystic fibrosis (CF) ARCT-810 (OTC deficiency) Phase 2 interim data on track for Q4 Kostaive® on track for Q4 commercial launch in Japan Investor conference call at 4:30 p.m. ET today SAN DIEGO--(BUSINESS WIRE)--August. 5, 2024-- Arcturus Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a global messenger RNA medicines company focused on the de ...

Core Viewpoint - Arcturus Therapeutics Holdings Inc (ARCT) is positioned as a strong investment opportunity in the biotech sector, with significant stock market performance reflecting bullish sentiment [2][3]. Financial Performance - The stock was rated as a "BUY" at a price of $22.74, with a notable change of 87.34% compared to the S&P 500's 18.70% [3]. - The company reported revenues of approximately $38 million in 1Q24, primarily from the CSL agreement and a BARDA grant [10]. - Total cash-like instruments amounted to $345.3 million at the end of 1Q24, showing a slight decrease from $348.9 million in 4Q23 [10][12]. Revenue Streams - Revenue is derived from research and development partnerships, with expectations for growth due to the upcoming commercial launch of the Kostaive vaccine [6][7]. - The Kostaive vaccine launch is anticipated to trigger milestone payments under the CSL agreement, contributing to revenue expansion [7]. - The company has a quadrivalent seasonal influenza program in collaboration with CSL, further diversifying its revenue sources [7]. Product Pipeline - The ARCT-032 program, an mRNA inhaled therapy for cystic fibrosis, has shown promising interim results, positively impacting stock performance [8]. - The company is at a critical juncture with the Kostaive vaccine launch, which is expected to significantly influence future revenues [13]. Strategic Decisions - Arcturus is monetizing its stake in ARCALIS, a manufacturing joint venture in Japan, to become more asset-light and reduce fixed costs [12]. - The company has a robust cash runway sufficient for three years, excluding revenues from the Kostaive program [12]. Outlook - Revenue estimates for the current fiscal year are projected at $181.84 million, with expectations of reaching $229.34 million in the next fiscal year and $386.60 million two years ahead [13]. - The company is expected to become consistently profitable by 2026, indicating a positive long-term outlook [13]. Valuation - Updated bull and bear scenarios for 2026 suggest potential revenues of $386.6 million in a bullish case and $157.75 million in a bearish case, with corresponding price targets of $135.94 and $16.64 [21].

Core Insights - The world's first self-amplifying (sa-mRNA) COVID-19 vaccine for adults, ARCT-154, has been approved in Japan, demonstrating superior immunogenicity against Omicron variants compared to conventional mRNA vaccines [1][2] - The vaccine showed 100% efficacy against severe COVID-19 in healthy individuals aged 18-59 and over 90% efficacy in at-risk populations [2][6] Company Overview - CSL is a global biotechnology company with a diverse portfolio of lifesaving medicines, including vaccines and therapies for various conditions, employing 32,000 people and operating in over 100 countries [9] - Arcturus Therapeutics, founded in 2013, specializes in mRNA medicines and vaccines, with a focus on self-amplifying mRNA technology and a strong patent portfolio [10] Study Details - The integrated phase 1/2/3a/3b study involved 1,001 participants in the phase 1/2/3a study and 16,100 participants in the phase 3b study, assessing safety, immunogenicity, and efficacy of ARCT-154 [4][5] - The primary endpoints included vaccine efficacy, reactogenicity, safety, and immunogenicity, with results indicating a 94.1% neutralizing antibody seroconversion rate four weeks after the second dose [6][4] Efficacy Results - ARCT-154 demonstrated an absolute efficacy of 56.6% against any COVID-19, 95.3% against severe COVID-19, and 86.5% against death due to COVID-19 [6] - Efficacy against severe COVID-19 was 100% in healthy individuals aged 18-59 and 91.9% in those with underlying co-morbidities [6] Technology Insights - Self-amplifying mRNA vaccines, like ARCT-154, enhance the immune response by instructing the body to produce more mRNA and protein compared to standard mRNA vaccines [8]

Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q1 2024 Results Conference Call May 8, 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 Liam Hiester - Piper Sandler Yanan Zhu - Wells Fargo Ed Arce - H.C. Wainwrigh ...

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]