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Arcturus Therapeutics Holdings Inc. (ARCT)
Chart Events
Performance Outlook
| Previous Close | 47.27 |
| Open | 48.22 |
| Bid | 47.00 x 1200 |
| Ask | 0.00 x 1000 |
| Day's Range | 46.56 - 49.57 |
| 52 Week Range | 8.51 - 63.45 |
| Volume | 500,611 |
| Avg. Volume | 875,917 |
| Market Cap | 1.167B |
| Beta (5Y Monthly) | 3.36 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -2.52 |
| Earnings Date | Aug 10, 2020 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 66.64 |
- GlobeNewswire
Arcturus Therapeutics Announces that it has Initiated Dosing of its COVID-19 STARR™ mRNA Vaccine Candidate, LUNAR-COV19 (ARCT-021) in a Phase 1/2 study
Potential for highly differentiated COVID-19 vaccine profile with a single administration, at a low dose Clinical study data expected in Q4 2020 SAN DIEGO, Aug. 11, 2020 (GLOBE NEWSWIRE) -- 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 that all subjects in the first cohort have been dosed in the Phase 1/2 clinical study with its ARCT-021 investigational vaccine for COVID-19. The study is being conducted with CTI Clinical Trial and Consulting Services, a global CRO, and in collaboration with Duke-NUS Medical School in Singapore.“We are very pleased to have initiated dosing in our ARCT-021 Phase 1/2 study, and in fact, we have already completed dosing of all subjects in the first cohort of the study. Based on preclinical immunogenicity data, our self-replicating mRNA-based investigational vaccine could have a highly differentiated safety and efficacy profile, and may potentially allow vaccination at very low doses, and with a single administration. These favorable attributes could greatly facilitate mass vaccination campaigns necessary to control this global pandemic,” said Joseph Payne, President & CEO of Arcturus. “We look forward to sharing initial clinical data from this Phase 1/2 study in Q4 which we expect to enable dose selection for late phase clinical trials.”The ARCT-021 Phase 1/2 study includes two parts. In Phase 1, escalating doses will be administered as a single injection to younger adults aged 21 to 55 years old. Based upon the safety, immunogenicity and T-cell response data from this group, dose regimens will be selected for further evaluation in Phase 2 which includes cohorts in younger adults and older adults aged 56 to 80 years old. The study is listed with ClinicalTrials.gov Identifier: NCT04480957.ARCT-021 preclinical data has shown highly promising results with 100% seroconversion for neutralizing antibodies after a single administration using a very low 2 µg dose. Neutralizing antibodies continued to increase for 60 days after dosing. Preclinical results also demonstrated robust CD8+ T-cell Induction and a Th1 biased T-helper cellular immune response. The ARCT-021 vaccine candidate is devoid of viruses and does not utilize viral vectors or adjuvants. ARCT-021 utilizes Arcturus’ self-transcribing and replicating (STARR™) mRNA technology and is delivered with Arcturus’s proprietary LUNAR® lipid-mediated delivery system.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 self-replicating mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Cardiovascular Disease 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 (192 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, and the Cystic Fibrosis Foundation. For more information visit www.ArcturusRx.comForward 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, including those regarding the likelihood of success, efficacy or safety of ARCT-021 as a vaccine against COVID-19 and therapeutic potential thereof based on the Company’s mRNA therapeutics, the timing of the release of ARCT-021 clinical data for human trials of a vaccine against COVID-19, the likelihood that ARCT-021 preclinical data will be predictive of clinical data, the expected dose size and required number of doses of ARCT-021 that may be approved for use by any applicable regulatory authority 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, 2019, filed with the SEC on March 16, 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 Arcturus Therapeutics Neda Safarzadeh (858) 900-2682 IR@ArcturusRx.comKendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008 ctanzi@kendallir.comClinical Site Contact Email: imu@singhealth.com.sg Phone: 6323 7544/8318 0685
- Zacks
Arcturus Therapeutics (ARCT) Reports Q2 Loss, Misses Revenue Estimates
Arcturus Therapeutics (ARCT) delivered earnings and revenue surprises of -3.77% and -54.31%, respectively, for the quarter ended June 2020. Do the numbers hold clues to what lies ahead for the stock?
- GlobeNewswire
Arcturus Therapeutics Announces Second Quarter 2020 Financial Results and Provides a Corporate Update
COVID-19 STARR™ mRNA vaccine candidate, ARCT-021 (LUNAR-COV19) has initiated Phase 1/2 clinical study with Duke-NUS Medical School; Dosing anticipated imminently, initial data expected Q4 ARCT-810 (LUNAR-OTC), mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency, Phase 1 healthy volunteer study continues to advance, initial results expected Q4Successfully raised approximately $280 million in gross proceeds through two public equity offerings in 2020 to advance promising clinical stage pipelineInvestor Conference Call at 4:30 p.m. ET TodaySAN DIEGO, Aug. 10, 2020 (GLOBE NEWSWIRE) -- 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 quarter ended June 30, 2020, and provided a corporate update.“Arcturus has made substantial recent corporate progress highlighted by the advancement of two of our programs, ARCT-021 and ARCT-810, into clinical studies. ARCT-021 has the potential to be an effective and safe vaccine for COVID-19 with a differentiated profile characterized by a very low dose, and a single shot administration. We have also continued to advance our Phase 1 ARCT-810 clinical study in healthy volunteers. ARCT-810 is being developed for ornithine transcarbamylase (OTC) deficiency, a serious disease with limited treatment options. We look forward to obtaining clinical data from both of these important programs this year,” said Joseph Payne, President & CEO of Arcturus.Recent corporate highlights * ARCT-021 program update: Phase 1/2 study with ARCT-021, COVID-19 STARR™ mRNA vaccine candidate (LUNAR-COV19), which is being conducted in collaboration with Duke-NUS Medical School and performed in Singapore, has initiated and commenced screening subjects. Dosing of the first subject anticipated imminently. Arcturus has provided preclinical data demonstrating a robust cellular (CD8+ cells) and balanced (Th1/Th2) immune response following ARCT-021 administration. Data demonstrate a strong antibody response (anti-spike protein IgG and 100% virus neutralization) at a very low vaccine dose, and a single administration. Neutralizing antibody levels continue to increase out to 60 days post administration. Preclinical data indicate that ARCT-021 is effectively activating the two important components of the adaptive immune response, providing strong support for the ongoing clinical program. * The Company continues to advance its ARCT-021 manufacturing activities. With the Company’s manufacturing partners, Arcturus is positioned to manufacture millions of doses in 2020 and potentially hundreds of millions of doses annually thereafter. * Executed binding term sheet with the Israeli Ministry of Health to supply ARCT-021. A definitive supply agreement is expected shortly. Israel is the second country, in addition to Singapore, to reserve supply of ARCT-021 from the Company. * Announced the formation of a vaccine platform Scientific Advisory Board. The SAB includes renowned experts in virology, infectious disease, vaccine development and public health. * Initiated a Phase 1 study with ARCT-810, a mRNA-based therapeutic candidate for ornithine transcarbamylase (OTC) deficiency (LUNAR-OTC). The ARCT-810 program is supported by preclinical data in OTC deficiency murine models demonstrating that dosing of ARCT-810 results in robust OTC protein expression and improvements in ureagenesis and plasma ammonia, and increased survival. The Company expects to obtain initial Phase 1 healthy volunteer study data in Q4 2020. The phase 1b study in patients has, like many other studies, been affected by the COVID situation, but remains on track to dose by end of year. * Successfully raised approximately $280 million in gross proceeds through public equity offerings in 2020 to date. The Company intends to use the net proceeds of the offerings to develop, test and manufacture the Company’s LUNAR-COV19 vaccine candidate and to continue clinical development of LUNAR-OTC; to advance the Company’s LUNAR-CF, LUNAR-CV and LUNAR-FLU preclinical programs into clinical development; to fund early research and development of novel and proprietary RNA medicines; and for general corporate and working capital purposes.Financial results for the quarter ended June 30, 2020 Revenues in conjunction with strategic alliances and collaborations: Arcturus’ primary source of revenues is from license fees and collaborative payments received from research and development arrangements with pharmaceutical and biotechnology partners. For the three months ended June 30, 2020, the Company reported revenue of $2.3 million, compared with $10.2 million in the three months ended June 30, 2019. The decline in collaboration revenues primarily relates to a $3.1 million decrease in reimbursements from CureVac associated with the OTC collaboration that ended in the second quarter of 2019. Additionally, in 2019 we recorded $3.1 million in sublicense revenues related to our agreement with Synthetic Genomics which was a one-time event.Operating expenses: Total operating expenses for the three months ended June 30, 2020 were $12.4 million compared with $10.7 million for the same period of 2019. The current quarter operating expenses were partially offset with $3.8 million of funds earned under the Singapore vaccine grant and $0.9 million in funds awarded by the CF Foundation.Net loss: For the three months ended June 30, 2020, Arcturus reported a net loss of approximately $10.3 million, or ($0.55) per basic and diluted share, compared with a net loss in the three months ended June 30, 2019 of $0.7 million, or ($0.07) per basic and diluted share.Cash, cash equivalents, and investments: Totaled $136.1 million as of June 30, 2020, compared to cash and cash equivalents of $71.4 million at December 31, 2019. Subsequent to the end of the quarter, the Company added net proceeds of $186.3 million from our successful public offering at $53 per share. Our Proforma Cash balance including the public offering, would have been $322.4 million. Based on our current pipeline, the Company’s current cash position is expected to be sufficient to support operations for more than two years. We are currently comfortable with our current cash position and we believe that the Company has the resources needed to drive our pipeline forward to reach several meaningful value creation milestones.Conference Call Monday August 10th @ 4:30 p.m. ET Domestic: 800-754-1346 International: 212-231-2909 Conference ID: 21967092 Webcast: http://public.viavid.com/index.php?id=141066 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 self-replicating mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Cardiovascular Disease 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 (192 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, and the Cystic Fibrosis Foundation. For more information visit www.ArcturusRx.comForward 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, including those regarding strategy, future operations, collaborations, the likelihood of success efficacy or safety of ARCT-021 or ARCT-810, the ability to initiate or complete preclinical and clinical development programs, including as a result of the COVID-19 pandemic, the supply and delivery of any product or substance, the likelihood that preclinical data will be predictive of clinical data, the ability to enroll subjects therein, the Company’s efforts to develop a vaccine against COVID-19 and therapeutic potential thereof based on the Company’s mRNA therapeutics, the timing of initiation of dosing in human trials of a vaccine against COVID-19, the ability of the Company to scale up manufacturing of vaccine doses, the potential manufacturing capabilities of the Company’s partnership with Catalent, our 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, 2019, filed with the SEC on March 16, 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 Contact Arcturus Therapeutics Neda Safarzadeh (858) 900-2682 IR@ArcturusRx.comKendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008 ctanzi@kendallir.comARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (in thousands, except par value information) June 30, December 31, 20202019 (unaudited) Assets Current assets: Cash and cash equivalents$136,111 $71,353 Accounts receivable 2,829 2,179 Prepaid expenses and other current assets 3,060 758 Total current assets 142,000 74,290 Property and equipment, net 2,610 2,349 Operating lease right-of-use asset, net 5,218 5,134 Equity-method investment — 263 Non-current restricted cash 107 107 Total assets$149,935 $82,143 Liabilities and stockholders' equity Current liabilities: Accounts payable$4,395 $5,793 Accrued liabilities 11,883 7,134 Deferred revenue 6,768 8,397 Total current liabilities 23,046 21,324 Deferred revenue, net of current portion 14,013 15,182 Long-term debt 15,059 14,995 Operating lease liability, net of current portion 4,394 4,850 Total liabilities$56,512 $56,351 Stockholders' equity Common stock: $0.001 par value; 30,000 shares authorized; 20,610 and 15,138 issued and outstanding at June 30, 2020 and December 30, 2019, respectively. 21 15 Additional paid-in capital 185,110 97,445 Accumulated deficit (91,708) (71,668) Total stockholders' equity 93,423 25,792 Total liabilities and stockholders' equity$149,935 $82,143 ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except per share data) Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Collaboration revenue$2,322 $10,153 $4,968 $14,503 Operating expenses: Research and development, net 7,944 7,269 15,861 14,593 General and administrative 4,420 3,456 8,611 6,990 Total operating expenses 12,364 10,725 24,472 21,583 Loss from operations (10,042) (572) (19,504) (7,080) Loss from equity-method investment (100) — (263) (288) Finance expense, net (121) (113) (273) (201) Net loss$(10,263) $(685) $(20,040) $(7,569) Net loss per share, basic and diluted$(0.55) $(0.07) $(1.20) $(0.74) Weighted-average shares outstanding, basic and diluted 18,794 10,412 16,657 10,255 Comprehensive loss: Net loss$(10,263) $(685) $(20,040) $(7,569) Comprehensive loss$(10,263) $(685) $(20,040) $(7,569)
