Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q2 2023 Earnings Conference Call August 7, 2023 4:30 PM ET Company Participants Neda Safarzadeh - VP, Head IR, Public Relations and Marketing Joseph Payne - President and CEO Andy Sassine - CFO Pad Chivukula - CSO and COO Conference Call Participants Yasmeen Rahimi - Piper Sandler Myles Minter - William Blair Evan Wang - Guggenheim Securities Pete Stavropoulos - Cantor Fitzgerald Yanan Zhu - Wells Fargo Carly Kenselaar - Citi Thomas Yip - H.C. Wainwright Yal ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 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, 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 oth ...

Financial Data and Key Metrics Changes - Total revenues for Q1 2023 were $80.3 million, a significant increase from $5.2 million in Q1 2022, primarily due to a $78.2 million increase related to the agreement with CSL [17] - Operating expenses for Q1 2023 were $65.5 million, up from $38.8 million in Q4 2022, driven by increased manufacturing costs and clinical trial expenses [17] - The company reported a net income of approximately $50.8 million or $1.87 per diluted share for Q1 2023, compared to a net loss of $51.2 million or $1.94 per diluted share in Q1 2022 [18] Business Line Data and Key Metrics Changes - The ARCT-154 COVID-19 vaccine Phase 3 program is the most advanced clinical program, with a new drug application submitted by collaborator Meiji for potential approval [6][7] - ARCT-810, an mRNA therapeutic candidate for OTC deficiency, is being evaluated in two ongoing clinical studies, with interim Phase 2 data expected later in 2023 [10][11] - ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis, has completed enrollment in a Phase 1 study and plans to expand to include CF patients in Q3 2023 [12][13] Market Data and Key Metrics Changes - Approximately 57 million mRNA boosters have been distributed in Japan since September 1, 2022, indicating a significant market opportunity for ARCT-154 [26] - The company expects to collect $90 million in Q2 2023 associated with CSL milestones achieved in Q1 2023 [19] Company Strategy and Development Direction - The company aims to leverage its mRNA platform for the development of next-generation vaccines, including those targeting COVID-19 and influenza [20] - The strategic collaboration with CSL focuses on the commercialization of mRNA vaccines, with a profit split of 60/40 [69] - The company is preparing for potential product approvals and is optimistic about the broader platform opportunity for mRNA technologies [7][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial position, with a cash runway extended to early 2026 based on current pipeline assumptions [19] - The company is focused on achieving multiple near-term milestones for its vaccine and therapeutic programs over the next nine months [19] Other Important Information - The company eliminated $60 million in long-term debt obligations, improving its balance sheet significantly [15][16] - An advanced payment of $23.6 million was received from CSL for the manufacturing and supply of ARCT-154, indicating strong financial backing for ongoing projects [15][19] Q&A Session Summary Question: Timeline for booster data submission - Management confirmed that the interim Phase 3 safety and immunogenicity booster data are undergoing final analysis and should be submitted to the PMDA later this quarter [23] Question: Market opportunity in Japan - Management highlighted that approximately 57 million mRNA boosters have been distributed in Japan, providing a basis for market calculations [26] Question: Non-inferiority margin for ARCT-154 study - The study is evaluating both the original Wuhan strain and variants of concern, with a non-inferiority threshold of 0.67 [30][31] Question: Future milestones with CSL - Management did not provide specific guidance on future milestones but indicated that they would report them as they are achieved [32] Question: Expansion to CF patients for ARCT-032 - Management confirmed plans to amend the protocol to include CF patients and will provide updates on potential data later in 2023 [41][42] Question: Competitive positioning of ARCT-154 - Management stated that the self-amplifying mRNA technology could potentially lead to higher neutralization titers and longer duration, which may enhance its competitive position [58]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 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, 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 ot ...

Financial Data and Key Metrics Changes - The company reported revenues of $160.3 million for Q4 2022, a significant increase from $5.8 million in Q4 2021, primarily driven by the CSL collaboration upfront payment [24][25] - Total operating expenses decreased to $38.8 million in Q4 2022 from $43.4 million in Q4 2021, mainly due to lower COVID-19-related expenses [25] - The net income for Q4 2022 was approximately $117.3 million, or $4.43 per diluted share, compared to a net loss of $38.7 million, or $1.47 per diluted share in Q4 2021 [25] - For the fiscal year 2022, the company reported a net income of $9.3 million for the first time in its history [26] Business Line Data and Key Metrics Changes - The strategic collaboration with CSL Seqirus resulted in a $200 million upfront payment and an additional $90 million invoiced for development milestones related to COVID-19 and seasonal flu vaccine programs [21][22] - The agreement with Meiji Pharma for ARCT-154 as a booster vaccine for COVID-19 is progressing well, with the Phase 3 study in Japan fully enrolled with over 800 participants [10][22] Market Data and Key Metrics Changes - Japan has one of the highest rates of COVID booster vaccination, and the government is focused on public health, which is expected to drive high levels of COVID booster utilization for years [9] - The collaboration with CSL is aimed at developing next-generation mRNA vaccines targeting COVID, influenza, and other pathogens, leveraging CSL's manufacturing infrastructure and Arcturus' mRNA expertise [8] Company Strategy and Development Direction - The company aims to advance its RNA platform technology and earlier-stage clinical programs while strengthening its management team with experienced leaders in mRNA therapeutics and vaccine development [6][18] - The focus is on achieving multiple near-term value-creating milestones for vaccine and therapeutic programs over the next 12 months [26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the collaboration with CSL, highlighting early milestones achieved and the potential for significant commercial opportunities [27] - The company expects to report interim clinical data for ARCT-810 and ARCT-032 later this year, showcasing the applications of its proprietary mRNA and delivery technologies [27] Other Important Information - The renegotiation of a manufacturing loan with the Singapore government resulted in a significant reduction of the loan obligation, enhancing the company's financial position [23] - The cash runway is projected to extend to the beginning of 2026, based on current pipeline assumptions [24] Q&A Session Summary Question: Progress on the Meiji trial and expectations for clinical data - Management confirmed that the primary objective of the trial is to establish non-inferiority compared to Comirnaty, with relevant immunogenicity data being collected [30] Question: Non-inferiority margin and potential economics from Japanese regulatory approval - The trial is powered to achieve statistical relevance, and while specific economic guidance is not provided, it will be shared when available [37][38] Question: Enrollment rate and kinetics of response for the OTC program - Nine active sites have been onboarded for the OTC deficiency trial, with a six-administration trial design allowing for kinetic data collection after each dose [45] Question: Initial healthy volunteer data for the cystic fibrosis program - Initial feedback from the Phase 1 study in New Zealand may be available this year, with potential for adding cystic fibrosis patients depending on safety data [48] Question: Characteristics of patients enrolled in the OTC deficiency program - The focus is on stable adult and adolescent subjects, with expectations for biological impact across the patient population [50][53]

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, 2022 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 ...

Next Generation RNA Medicines January 2023 Forward Looking Statements This presentation contains forward-looking statements. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future performances or achievements expressed or implied by the forward-looking statements. Each of these statements is based only on current information, assumptions and expect ...

Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) Q3 2022 Results Conference Call November 9, 2022 4:30 PM ET Company Participants Kyle Gutsadt - Investor Relations Joseph Payne - President and Chief Executive Officer Andrew Sassine - Chief Financial Officer Padmanabh Chivukula - Chief Scientific Officer and Chief Operating Officer Conference Call Participants Seamus Fernandez - Guggenheim Yigal Nochomovitz - Citi Pete Stavropoulos - Cantor Fitzgerald Yale Jen - Laidlaw and Company Yanan Zhu - Wells Fargo S ...

Financial Performance - Total revenue for the three months ended September 30, 2022, was $13.369 million, a significant increase from $2.437 million for the same period in 2021, representing a growth of approximately 449%[16] - The net loss for the three months ended September 30, 2022, was $35.266 million, compared to a net loss of $54.084 million for the same period in 2021, indicating an improvement of approximately 35%[16] - The company reported a comprehensive loss of $35.266 million for the three months ended September 30, 2022, compared to a comprehensive loss of $54.084 million for the same period in 2021[16] - The net loss for the nine months ended September 30, 2022, was $107,998 thousand, an improvement from a net loss of $165,011 thousand for the same period in 2021, representing a reduction of approximately 34.5%[25] - The company reported a significant increase in revenue, reaching $150 million for the quarter, representing a 25% year-over-year growth[149] Cash and Assets - Cash and cash equivalents as of September 30, 2022, were $237.676 million, down from $370.492 million as of December 31, 2021, reflecting a decrease of about 36%[14] - Total assets decreased to $293.627 million as of September 30, 2022, from $392.814 million as of December 31, 2021, a decline of approximately 25%[14] - The company had $237.7 million in unrestricted cash and cash equivalents as of September 30, 2022[120] - As of September 30, 2022, total cash, cash equivalents, and restricted cash decreased to $239.8 million from $416.0 million as of September 30, 2021, representing a decline of approximately 42.4%[45] Expenses - Operating expenses for the three months ended September 30, 2022, were $50.176 million, a decrease of 11% compared to $56.258 million for the same period in 2021[16] - Research and development expenses for the nine months ended September 30, 2022, totaled $120.770 million, down from $141.127 million for the same period in 2021, a decrease of approximately 14%[16] - General and administrative expenses for the nine months ended September 30, 2022, were $13,270,000, up from $11,265,000 in the same period of 2021, representing an increase of 18%[84] - Research and development expenses for the three months ended September 30, 2022, were $3,996,000, compared to $3,304,000 for the same period in 2021, reflecting an increase of 21%[84] Liabilities - Total liabilities decreased to $147.960 million as of September 30, 2022, from $164.603 million as of December 31, 2021, representing a reduction of about 10%[14] - The accumulated deficit increased to $(455.488) million as of September 30, 2022, compared to $(347.490) million as of December 31, 2021[19] - The company had an accumulated deficit of $455,500 thousand as of September 30, 2022, up from $347,500 thousand at the end of 2021, indicating a 31% increase in accumulated losses[35] Revenue Recognition - The Company recognized $11.2 million as revenue during the period ended September 30, 2022, related to the Vinbiocare agreement, with no remaining performance obligations[50] - The upfront consideration of $5.0 million from the CureVac agreement is being recognized as revenue on a straight-line basis over the remaining 10-month contractual term[57] - The Israel Supply Agreement with the Israeli Ministry of Health was terminated, and the Company recognized a payment of $12.5 million as revenue in Q2 2022[59] - The company received an upfront payment of $200 million from CSL Seqirus as part of a collaboration agreement for the development of self-amplifying mRNA vaccines[95] Collaborations and Agreements - The Company has entered into various collaborative research and development arrangements, which include milestone payments contingent on achieving specific research and development milestones[44] - The collaboration agreement with CSL Seqirus could yield over $1.3 billion in development milestones and up to $3 billion in commercial milestones based on net sales of vaccines[95] - The Company entered into a cost reimbursement contract with BARDA for an award of up to $63.2 million for the development of a pandemic influenza vaccine[62] - The effectiveness of the collaboration and license agreement with CSL Seqirus is subject to regulatory approval, and failure to obtain such approval could adversely affect future business and financial results[143] Market and Growth - The company is expanding its market presence in Asia, targeting a 30% increase in market share by the end of the fiscal year[149] - New product launches are expected to contribute an additional $20 million in revenue over the next two quarters[149] - The company is focused on strategic partnerships to enhance its research and development capabilities in the biopharmaceutical sector[152] - Arcturus Therapeutics is actively pursuing market expansion through collaborations and licensing agreements with established firms[152] Clinical Trials and Development - Arcturus is advancing its LUNAR-OTC/ARCT-810 program for ornithine transcarbamylase deficiency, with a Phase 2 study expected to begin dosing in Q4 2022[104] - The company expects to file an application for a first-in-human study for its cystic fibrosis candidate ARCT-032 by the end of 2022[105] - The company is currently conducting Phase 1/2/3 clinical trials of ARCT-154 in Vietnam, with results critical for the success of its COVID-19 vaccine program[144] Regulatory and Compliance - The company has emphasized the importance of maintaining financial stability through amendments to its loan agreements[152] - The company has incorporated various equity incentive plans, including the 2021 Inducement Equity Incentive Plan and the Amended and Restated 2019 Omnibus Equity Incentive Plan[152] - The company has filed multiple certifications under the Securities Exchange Act of 1934, ensuring compliance with regulatory requirements[154] - The company is committed to transparency and regulatory compliance as evidenced by its multiple filings and certifications[154]

Acrturus Therapeutics Holdings Inc. Q2 2022 Earnings Conference Call August 9, 2022 4:30 PM ET Company Participants Joseph Payne - President and Chief Executive Officer Andrew Sassine - Chief Financial Officer Pad Chivukula - Chief Scientifc Officer and Chief Operating Officer Conference Call Participants Pete Stavropoulos - Cantor Fitzgerald Nick Abbott - Wells Fargo Kumaraguru Raja - Brookline Capital Markets Yale Jen - Laidlaw and Company Yigal Nochomovitz - Citigroup Steven Seedhouse - Raymond James Ope ...