Prothena Corporation plc
May 8, 2018

Prothena Reports First Quarter 2018 Financial Results and Provides R&D Update

DUBLIN, Ireland, May 08, 2018 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage biotechnology company focused on the discovery and development of novel therapies in the neuroscience and orphan categories, today reported financial results for the first quarter of 2018. In addition, the Company provided an update on its R&D programs.

"We are moving several programs in our clinical and discovery pipeline forward and have recently initiated a Phase 1 study of PRX004 in patients with ATTR amyloidosis," said Gene Kinney, PhD, President and Chief Executive Officer of Prothena. "Through our recently announced neuroscience R&D collaboration with Celgene, we are advancing three discovery programs that target a broad range of neurodegenerative diseases. While we recently discontinued development of NEOD001, we remain focused on pursuing new and better treatment options for patients through a scientifically rigorous approach in our research and development efforts."

First Quarter 2018 and Recent Highlights:

Upcoming Research and Development Milestones

PRX002/RG7935

PRX004

First Quarter 2018 Financial Results and Updated 2018 Financial Guidance

Prothena reported a net loss of $48.7 million for the first quarter of 2018, as compared to a net loss of $35.4 million for the first quarter of 2017. Net loss per share for the first quarter of 2018 was $1.26, as compared to a net loss per share of $0.99 for the first quarter of 2017.

Prothena reported total revenue of $0.2 million for the first quarter of 2018, as compared to total revenue of $0.3 million for the first quarter of 2017 from our collaboration with Roche.

Research and development (R&D) expenses totaled $34.7 million for the first quarter of 2018, as compared to $25.7 million for the first quarter of 2017. The increase in R&D expenses for the first quarter of 2018 compared to the same period in the prior year was primarily due to higher consulting expenses, higher personnel costs, higher expense associated with PRX002/RG7935 and to a lesser extent higher clinical trial costs partially offset by lower product manufacturing expenses. R&D expenses included non-cash share-based compensation expense of $2.3 million for the first quarter of 2018, as compared to $2.3 million for the first quarter of 2017.

General and administrative (G&A) expenses totaled $14.2 million for the first quarter of 2018, as compared to $10.8 million for the first quarter of 2017. The increase in G&A expenses for the first quarter of 2018 compared to the same period in the prior year was primarily due to higher personnel costs and to a lesser extent higher legal expense. G&A expenses included non-cash share-based compensation expense of $4.6 million in the first quarter of 2018, as compared to $3.3 million in the first quarter of 2017.

Total non-cash share-based compensation expense was $6.9 million for the first quarter of 2018, as compared to $5.6 million for the first quarter of 2017.

As of March 31, 2018, Prothena had $433.1 million in cash, cash equivalents and restricted cash and no debt.

As of April 20, 2018, Prothena had approximately 39.8 million ordinary shares outstanding.

With the recent discontinuation of the NEOD001 program, the Company is assessing its resources relative to its current pipeline and is developing a reorganization plan. It expects to provide an update during the second quarter on reorganization plans and financial guidance for 2018.

About Prothena

Prothena Corporation plc is a global clinical-stage biotechnology company focused on the discovery and development of novel therapies in the neuroscience and orphan categories. Fueled by its deep scientific understanding built over decades of research in protein misfolding, Prothena seeks to fundamentally change the course of progressive, life-threatening diseases associated with this biology. Prothena is advancing a pipeline of antibody therapeutic candidates for a number of indications and novel targets including Parkinson's disease and other related synucleinopathies (PRX002/RG7935) and ATTR amyloidosis (PRX004), as well as tau, Aβ (Amyloid beta) and TDP-43 where its scientific understanding of disease pathology can be leveraged. For more information, please visit the Company's website at www.prothena.com and follow us @ProthenaCorp.

Forward-looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash to support advancement of our R&D pipeline through key milestones; our goal of moving several programs in our clinical and discovery pipeline forward, including those under our collaboration with Celgene; amounts we might receive under our collaboration with Celgene; our focus on pursuing new and better treatment options for patients; the design, proposed mechanism of action and potential therapeutic benefits of PRX004; the objective and design of the Phase 1 study of PRX004; the intended use of our proprietary assay as a pharmacodynamic measure across multiple hereditary TTR mutations; the expected timing of having data from the Phase 1 study of PRX004; the possibility of further studies of PRX004; enrollment in the Phase 2 study of PRX002; and our plan and timing to develop a reorganization plan and provide an update on that plan and financial guidance for 2018. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the risks, uncertainties and other factors described in the "Risk Factors" sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2018 and our subsequent Quarterly Reports on Form 10-Q filed with the SEC. Prothena undertakes no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in Prothena's expectations.

PROTHENA CORPORATION PLC
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)

  Three Months Ended
March 31,
  2018 2017
Collaboration revenue $227  $259 
Total revenue 227  259 
Operating expenses:    
Research and development 34,706  25,698 
General and administrative 14,229  10,832 
Total operating expenses 48,935  36,530 
Loss from operations (48,708) (36,271)
Other expense, net (72) (774)
Loss before income taxes (48,780) (37,045)
Benefit from income taxes (37) (1,661)
Net loss $(48,743) $(35,384)
Basic and diluted net loss per share $(1.26) $(0.99)
Shares used to compute basic and diluted net loss per share 38,684  35,758 
       

PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)

 March 31, December 31,
 2018 2017
Assets   
Cash and cash equivalents$429,039  $417,620 
Accounts receivable100,012  240 
Other current assets8,102  8,467 
Total current assets537,153  426,327 
Property and equipment, net54,278  54,990 
Restricted cash4,056  4,056 
Other assets11,160  10,956 
Total non-current assets69,494  70,002 
Total assets$606,647  $496,329 
Liabilities and Shareholders' Equity   
Accrued research and development$15,693  $13,509 
Other current liabilities19,862  23,862 
Total current liabilities35,555  37,371 
Deferred revenue110,242   
Other non-current liabilities51,345  51,769 
Total non-current liabilities161,587  51,769 
Total liabilities197,142  89,140 
Total shareholders' equity409,505  407,189 
Total liabilities and shareholders' equity$606,647  $496,329 
 

Media and Investor Contact:

Ellen Rose, Head of Communications
650-922-2405, ellen.rose@prothena.com