SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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Item 2.02. Results of Operations and Financial Conditions.
On May 10, 2021, Arcturus Therapeutics Holdings Inc. (the “Company” or “Arcturus”) issued a press release, a copy of which is furnished herewith as Exhibit 99.1, announcing the Company’s financial results for the quarter ended March 31, 2021 and providing a corporate update (the “Press Release”).
The information contained in Item 2.02 of this Current Report on Form 8-K, including the Press Release, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. In addition, this information shall not be deemed incorporated by reference into any of the Company’s filings with the Securities and Exchange Commission (the “SEC”), except as shall be expressly set forth by specific reference in any such filing.
Item 7.01. Regulation FD Disclosure.
The Company has made available a presentation about its business (the “Presentation”), a copy of which is furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K and is hereby incorporated by reference.
The furnishing of the Presentation is not an admission as to the materiality of any information therein. The information contained in the Presentation is summary information that should be considered in the context of the Company’s filings with the SEC and other public announcements the Company may make by press release or otherwise from time to time.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this Current Report on Form 8-K, the Press Release and the Presentation are “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this Current Report on Form 8-K, the Press Release and the Presentation, including those regarding strategy, future operations, collaborations, the likelihood of success, and the efficacy or safety, of the Company’s pipeline, including ARCT-021, ARCT-810 or ARCT-032, the potential administration regimen or dosage, or ability to administer multiple doses of, any of Company’s drug candidates, the ability to enroll subjects in clinical trials, the Company’s efforts to develop a vaccine against COVID-19 and therapeutic potential thereof based on the Company’s mRNA therapeutics, the Company’s manufacturing methods and technologies (including purification and lyophilization, and stability of manufactured product), the ability of the Company to scale up manufacturing of products or substances, the likelihood that a patent will issue from any patent application, its current cash position and expected cash burn and the impact of general business and economic conditions, are forward-looking statements. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading “Risk Factors” in Arcturus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC on March 1, 2021 and in subsequent filings with, or submissions to, the SEC.
The statements made in this Current Report on Form 8-K, the Press Release and the Presentation speak only as of the date stated herein, and subsequent events and developments may cause the Company’s expectations and beliefs to change. While the Company may elect to update these forward-looking statements publicly at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date after the date stated herein.
Item 9.01 Financial Statements and Exhibits.
|Exhibit No.||Description of Exhibit|
|99.1||Press Release dated May 10, 2021|
|99.2||Presentation dated May 2021|
|104||Cover Page to this Current Report on Form 8-K in Inline XBRL|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Arcturus Therapeutics Holdings Inc.|
|Date: May 10, 2021|
|Name:||Joseph E. Payne|
|Title:||Chief Executive Officer|
Arcturus Therapeutics Announces First Quarter 2021 Company Overview and
Financial Results and Provides New Clinical Data
ARCT-021 Phase 2 interim data showed favorable safety profile and greater than 90% seroconversion after a single dose; data supports advancement into Phase 3
In negotiations with multiple regulatory authorities regarding ARCT-021 Phase 3 study program
Continued progress advancing mRNA therapeutic platform, including liver (ARCT-810) and lung (ARCT-032) targeted programs
Investor conference call at 4:30 p.m. ET today
San Diego, Calif, May 10, 2021 – Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, today announced its financial results for the first quarter ended March 31, 2021 and provided corporate updates.
“Arcturus has made continued progress advancing our clinical pipeline, highlighted by our development efforts for ARCT-021, a differentiated mRNA vaccine candidate targeting COVID-19. Based on promising data from our Phase 1/2 study, and the new interim safety and immunogenicity data from our Phase 2 study, we are looking forward to initiating ARCT-021 Phase 3 study as well as the continued advancement of our other pipeline programs,” said Steve Hughes, M.D., Chief Medical Officer of Arcturus.
“Our Self-Transcribing and Replicating mRNA (STARR™) delivered with our LUNAR® delivery system potentially has important differences from currently authorized mRNA vaccines for emergency use. We believe that ARCT-021, as a single shot lyophilized self-amplifying mRNA vaccine, if approved, may represent a preferred vaccine option. We are very pleased with the recent successes in our mRNA drug product manufacturing efforts, and in the expansion of our global safety database – and the positive readthrough this provides to the Company’s pipeline of mRNA therapeutics. We eagerly look forward to the next major development milestones for our vaccine, liver, and lung mRNA pipeline programs,” said Joseph Payne, President & CEO of Arcturus.
Recent Corporate Highlights
ARCT-021, STARR™ mRNA Vaccine Candidate for SARS-CoV-2
Phase 2 study:
|·||Completed enrollment with 580 participants randomized and dosed|
|·||Completed two interim analyses of the Phase 2 data which have been reviewed by the Data and Safety Monitoring Board (DSMB) with recommendation to proceed with no changes to protocol|
|·||Data support initiation of Phase 3 study evaluating a single shot regimen of 5 microgram (µg)|
|·||Interim immunogenicity data confirm high seroconversion rate (> 90%) at day 28 for IgG antibodies binding the full-length spike protein following a single 5 µg dose|
|·||Phase 2 study is ongoing and the Company remains blinded to full trial data; data from additional endpoints are expected, including neutralizing antibody and T-cell data, during H2 2021|
Phase 3 study:
|·||Single dose of 5 μg selected as the regimen for evaluation in Phase 3|
|·||In negotiations with multiple regulatory authorities regarding Phase 3 study|
|·||Completed GMP manufacturing and release of lyophilized ARCT-021 to support Phase 3|
|·||Completed stockpiling of greater than 10 million doses of lyophilized ARCT-021|
|·||Manufacturing capacity in place to support vaccine supply requirements under potential Emergency Use Authority (EUA)|
|·||Lyophilized ARCT-021 stability predicted to be longer than 1 year at -20°C; stability studies at -20°C, 2-8°C and room temperature are ongoing|
ARCT-810, mRNA Therapeutic Candidate for Ornithine Transcarbamylase (OTC) Deficiency
|·||Two additional sites in U.S. activated to support ongoing Phase 1b study|
|·||9-month (20 doses) chronic toxicology study completed in non-human primates with no adverse histological findings; doses exceeded maximum targeted clinical dose|
|·||On track to file CTA this quarter for Phase 2 multiple dose study; ethics committee submission completed|
ARCT-032, mRNA Therapeutic Candidate for Cystic Fibrosis
|·||CTA filing on track for Q4|
Financial results for the quarter ended March 31, 2021
Revenues in conjunction with strategic alliances and collaborations: Arcturus’ primary sources of revenues were from license fees and collaborative payments received from research and development arrangements with pharmaceutical and biotechnology partners. For the three months ended March 31, 2021, the Company reported revenue of $2.1 million, compared with $2.6 million in the three months ended March 31, 2020.
Operating expenses: Total operating expenses for the three months ended March 31, 2021 were $59.8 million compared with $12.1 million for the three months ended March 31, 2020 and $33.3 million for the three months ended December 31, 2020.
Research and development expenses increased by approximately $42.1 year over year and $25.8 million sequentially from the fourth quarter of 2020. The primary driver of the sequential increase was driven by higher clinical and manufacturing cost of $17.2 million for our ARCT-021 program. The remaining increase was primarily driven by higher personnel costs and related to the acquisition of an exclusive license from Alexion Pharmaceuticals for certain patent-pending inventions relating to nucleic acid purification technologies for approximately $5.0 million of Arcturus stock.
Net loss: For the three months ended March 31, 2021 Arcturus reported a net loss of approximately $56.3 million, or ($2.15) per basic and diluted share, compared with a net loss of $9.8 million, or ($0.67) per basic and diluted share in the three months ended March 31, 2020 and a net loss of $31.1 million, or ($1.25) per basic and diluted share in the three months ended December 31, 2020.
The Company’s cash balance totaled $466.9 million as of March 31, 2021, compared to cash and cash equivalents of $463.0 million at December 31, 2020. Based on our current plans, the Company’s cash position is expected to be sufficient to support operations for more than two years.
Monday, May 10th @ 4:30 p.m. ET
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, and Cystic Fibrosis along with partnered programs including Glycogen Storage Disease Type 3, Hepatitis B Virus, and non-alcoholic steatohepatitis (NASH). Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (209 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics Inc., Duke-NUS Medical School, and the Cystic Fibrosis Foundation. For more information visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, collaborations, the planned initiation, design or completion of clinical trials, the likelihood that the Company will obtain clearance from regulatory authorities to proceed with planned clinical trials, the likelihood that preclinical or clinical data will be predictive of future clinical results, the likelihood that clinical data will be sufficient for regulatory approval or completed in time to submit an application for regulatory approval within a particular timeframe, the likelihood of success (including safety and efficacy) of the Company’s pipeline, including ARCT-021, ARCT-810 or ARCT-032, the potential administration regimen or dosage, or ability to administer multiple doses of, any of Company’s drug candidates, the ability to enroll subjects in clinical trials, the Company’s efforts to develop a vaccine against COVID-19 and therapeutic potential thereof based on the Company’s mRNA therapeutics, the Company’s manufacturing methods and technologies (including purification and lyophilization, and stability of manufactured product), the ability of the Company to scale up manufacturing of products or substances, the likelihood that a patent will issue from any patent application, its current cash position and expected cash burn and the impact of general business and economic conditions. Actual results and performance could differ materially from those projected in any forward-looking statements as a result of many factors including, without limitation, the ability to enroll subjects in clinical trials as a result of the COVID-19 pandemic, the impact of commercialization of third-party COVID-19 vaccines on the design, and ability to conduct, clinical trials, the availability of manufacturing capacity and raw materials, unexpected clinical results, government regulations impacting the regulatory environment or intellectual property landscape, and general market conditions that may prevent such achievements or performance. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties, including those discussed under the heading "Risk Factors" in Arcturus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and in subsequent filings with, or submissions to, the SEC. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
IR and Media Contacts
Kendall Investor Relations
Carlo Tanzi, Ph.D.
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value information)
|Cash and cash equivalents||$||466,839||$||462,895|
|Prepaid expenses and other current assets||1,150||2,769|
|Total current assets||469,996||467,789|
|Property and equipment, net||3,427||3,378|
|Operating lease right-of-use asset, net||6,690||5,182|
|Non-current restricted cash||107||107|
|Liabilities and stockholders’ equity|
|Total current liabilities||53,333||49,521|
|Deferred revenue, net of current portion||11,313||12,512|
|Long-term debt, net of current portion||58,147||13,845|
|Operating lease liability, net of current portion||5,710||4,025|
|Other long-term liabilities||358||—|
|Common stock: $0.001 par value; 60,000 shares authorized; 26,319 issued and outstanding at March 31, 2021 and 26,192 issued and outstanding at December 31, 2020||26||26|
|Additional paid-in capital||552,743||540,343|
|Total stockholders’ equity||352,607||396,553|
|Total liabilities and stockholders’ equity||$||481,468||$||476,456|
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands except per share data)
|Three Months Ended|
|March 31,||December 31,|
|Research and development, net||50,050||7,917||24,286|
|General and administrative||9,743||4,191||9,034|
|Total operating expenses||59,793||12,108||33,320|
|Loss from operations||(57,666||)||(9,462||)||(31,082||)|
|Gain (loss) from equity-method investment||1,248||(163||)||—|
|Gain from foreign currency||430||—||16|
|Finance expense, net||(358||)||(152||)||(38||)|
|Net loss per share, basic and diluted||$||(2.15||)||$||(0.67||)||$||(1.25||)|
|Weighted-average shares outstanding, basic and diluted||26,243||14,521||24,886|