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
ARCT-810 (LUNAR-OTC), mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency, Phase 1 healthy volunteer study continues to advance, initial results expected Q4
Successfully raised approximately
Investor Conference Call at
“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
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 Schooland 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.
Israelis 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 SABincludes 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 millionin 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
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
Operating expenses: Total operating expenses for the three months ended
Net loss: For the three months ended
Cash, cash equivalents, and investments: Totaled
About Arcturus Therapeutics
Founded in 2013 and based in
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, 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
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Kendall Investor Relations
CONSOLIDATED BALANCE SHEETS
(in thousands, except par value information)
|Cash and cash equivalents||$||136,111||$||71,353|
|Prepaid expenses and other current assets||3,060||758|
|Total current assets||142,000||74,290|
|Property and equipment, net||2,610||2,349|
|Operating lease right-of-use asset, net||5,218||5,134|
|Non-current restricted cash||107||107|
|Liabilities and stockholders' equity|
|Total current liabilities||23,046||21,324|
|Deferred revenue, net of current portion||14,013||15,182|
|Operating lease liability, net of current portion||4,394||4,850|
|Additional paid-in capital||185,110||97,445|
|Total stockholders' equity||93,423||25,792|
|Total liabilities and stockholders' equity||$||149,935||$||82,143|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)
|Three Months Ended||Six Months Ended|
|Research and development, net||7,944||7,269||15,861||14,593|
|General and administrative||4,420||3,456||8,611||6,990|
|Total operating expenses||12,364||10,725||24,472||21,583|
|Loss from operations||(10,042||)||(572||)||(19,504||)||(7,080||)|
|Loss from equity-method investment||(100||)||—||(263||)||(288||)|
|Finance expense, net||(121||)||(113||)||(273||)||(201||)|
|Net loss per share, basic and diluted||$||(0.55||)||$||(0.07||)||$||(1.20||)||$||(0.74||)|
|Weighted-average shares outstanding, basic and diluted||18,794||10,412||16,657||10,255|
Source: Arcturus Therapeutics Holdings Inc.