EX-99.1 2 d821362dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

Arcturus Therapeutics Announces Third Quarter Financial Results and Provides Corporate Update

San Diego, Calif, November 7, 2019 – Arcturus Therapeutics Holdings Inc. (“Arcturus Therapeutics”) (NASDAQ: ARCT), a leading messenger RNA medicines company focused on the discovery, development and commercialization of therapeutics for rare diseases, today reported its financial results for the three- and nine-month periods ended September 30, 2019 and provided a corporate update.

Highlights

 

  •  

IND application for ARCT-810, a treatment of ornithine transcarbamylase (OTC) deficiency, is on track for Q1 2020 filing

 

  •  

Expanded platform with STARR technology™ to enable LUNAR® formulated RNA-based vaccines

 

  •  

Raised $23 Million from institutional investors at $11.50 per share of Common Stock

 

  •  

Strengthened the Board of Directors with the addition of Edward W. Holmes, M.D.

“We continue to develop our LUNAR® delivery and mRNA technology platforms, strengthening our leadership position in mRNA medicines. Our flagship program, ARCT-810, remains on track – we have successfully completed a GMP-manufactured batch of drug product, initiated IND-enabling toxicology studies, and plan to file an IND application during the first quarter of 2020,” said Joseph Payne, President and Chief Executive Officer of Arcturus. “Earlier this morning, we announced the expansion of our technology platform to include self-replicating RNA (STARR technology™) for human and animal health vaccine applications. Furthermore, we have successfully raised significant capital from institutional and strategic investors to fund our operations into 2021,” concluded Payne.

Financial Results for the Third quarter Ended September 30, 2019

Revenues in conjunction with strategic alliances and collaborations: Collaboration revenue was $3.3 million during the quarter ended September 30, 2019, compared to $3.4 million in the quarter ended September 30, 2018.

Operating Expenses: Operating expenses were $10.9 million in the quarter ended September 30, 2019, compared to $7.8 million in the quarter ended September 30, 2018.

Net Loss: Net loss for the quarter ended September 30, 2019 was approximately $7.4 million, or ($0.56) per basic and diluted share, compared with a net loss of $4.3 million, or ($0.42) per basic and diluted share, in the quarter ended September 30, 2018.

Cash: At September 30, 2019, Arcturus had cash and cash equivalents totaling $74.2 million, compared to cash, cash equivalents of $36.7 million at December 31, 2018. Subsequent to the end of the fiscal quarter we received approximately $7.0 million as a result of increasing our bank facility and an insurance settlement. This provides adequate funding to support the Company’s current programs through at least the first quarter of 2021.

Financial Results for the Nine months Ended September 30, 2019

Revenues in conjunction with strategic alliances and collaborations: Collaboration revenue was $17.8 million during the nine months ended September 30, 2019, compared to $8.2 million in the nine months ended September 30, 2018.

Operating expenses: Operating expenses were $32.5 million in the nine months ended September 30, 2019, compared to $29.3 million in the nine months ended September 30, 2018.

Net Loss: Net loss for the nine-month period ended September 30, 2019 was approximately $15.0 million, or ($1.18) per basic and diluted share, compared with a net loss of $20.8 million, or ($2.07) per basic and diluted share, in the nine-month period ended September 30, 2018.

Conference Call

Thursday, November 7th @ 4:30pm Eastern Time

 

Domestic:    800-458-4121
International:    323-794-2597
Conference ID:    7909937
Webcast:    http://public.viavid.com/index.php?id=136708

About Arcturus Therapeutics

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is an RNA medicines company with enabling technologies – LUNAR® lipid-mediated delivery, Unlocked Nucleomonomer Analog (UNA) chemistry, STARR technology™ – and mRNA drug substance along with drug product manufacturing. Arcturus’ diverse pipeline of RNA therapeutics includes programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, Glycogen Storage Disease Type 3, Hepatitis B, 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 (177 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. and the Cystic Fibrosis Foundation. For more information visit www.Arcturusrx.com.

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 of the Company’s technology or potential development of any products, the status of preclinical and clinical development programs, the planned initiation of clinical trials, the expected employment of key personnel, the adequacy of the Company’s funding relative to its capital requirements and the Company’s future cash and financial position, 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, 2018, filed with the SEC on March 18, 2019 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.

Contact

Neda Safarzadeh

Arcturus Therapeutics

(858) 900-2682

IR@ArcturusRx.com

Arcturus Investor Contacts

Michael Wood

LifeSci Advisors LLC

(646) 597-6983

mwood@lifesciadvisors.com

ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(In U.S. dollars in thousands, except par value information)

 

     September 30,
2019		      December 31,
2018		  
     (unaudited)         

Assets

      

Current assets:

      

Cash and cash equivalents

    $ 74,172      $ 36,709  

Accounts receivable

      2,625        4,481  

Prepaid expenses and other current assets

      2,611        638  
  

 

 

     

 

 

  

Total current assets

      79,408        41,828  

Property and equipment, net

      2,073        1,975  

Operating lease right-of-use asset, net

      5,324        —    

Equity-method investment

      303        288  

Non-current restricted cash

      107        107  
  

 

 

     

 

 

  

Total assets

    $ 87,215      $ 44,198  
  

 

 

     

 

 

  

Liabilities and shareholders’ equity

      

Current liabilities:

      

Accounts payable

    $ 4,013      $ 2,398  

Accrued liabilities

      6,676        3,907  

Deferred revenue

      10,999        6,272  
  

 

 

     

 

 

  

Total current liabilities

      21,688        12,577  

Deferred revenue, net of current portion

      14,551        7,534  

Long-term debt

      10,016        9,911  

Operating lease liability, net of current portion

      5,065        —    

Deferred rent

      —          534  
  

 

 

     

 

 

  

Total liabilities

      51,320        30,556  

Total stockholders’ equity

      35,895        13,642  
  

 

 

     

 

 

  

Total liabilities and stockholders’ equity

    $ 87,215      $ 44,198  
  

 

 

     

 

 

  

ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

U.S. dollars in thousands (except per share data)

 

     Three Months Ended     Nine Months Ended  
     September 30,     September 30,  
     2019     2018     2019     2018  

Collaboration revenue

    $ 3,318     $ 3,423     $ 17,821     $ 8,176  

Operating expenses:

         

Research and development, net

      7,053       3,969       21,646       12,135  

General and administrative

      3,881       3,810       10,871       17,141  
  

 

 

    

 

 

    

 

 

    

 

 

  

Total operating expenses

      10,934       7,779       32,517       29,276  
  

 

 

    

 

 

    

 

 

    

 

 

  

Loss from operations

      (7,616 )      (4,356 )      (14,696 )      (21,100 ) 

Gain (loss) from equity-method investment

      303       (47 )      15       (47 ) 

Finance (expense) income, net

      (120 )      150       (321 )      373  
  

 

 

    

 

 

    

 

 

    

 

 

  

Net loss

    $ (7,433 )    $ (4,253 )    $ (15,002 )    $ (20,774 ) 
  

 

 

    

 

 

    

 

 

    

 

 

  

Net loss per share, basic and diluted

    $ (0.56 )    $ (0.42 )    $ (1.18 )    $ (2.07 ) 

Weighted-average shares outstanding, basic and diluted

      13,201       10,093       12,734       10,059  

Comprehensive loss:

         

Net loss

    $ (7,433 )    $ (4,253 )    $ (15,002 )    $ (20,774 ) 

Unrealized gain on short-term investments

      —         2       —         7  
  

 

 

    

 

 

    

 

 

    

 

 

  

Comprehensive loss

    $ (7,433 )    $ (4,251 )    $ (15,002 )    $ (20,767 )