Prothena Corporation plc
May 3, 2016

Prothena Reports First Quarter 2016 Financial Results and Provides R&D Update


DUBLIN, Ireland, May 03, 2016 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, today reported financial results for the first quarter ended March 31, 2016. In addition, the Company provided an update on its R&D programs.

"During the first quarter of 2016, we initiated clinical trials for NEOD001 and PRX003," said Dale Schenk, PhD, President and Chief Executive Officer of Prothena. "Enrollment is now progressing for both the Phase 2b PRONTO trial in patients with AL amyloidosis which advances our comprehensive pivotal program for NEOD001, and the Phase 1b multiple ascending dose trial in patients with psoriasis which investigates PRX003 as a new approach to addressing immune-mediated diseases. As we look toward planning for commercialization of NEOD001, we also welcomed the addition of David McNinch as Chief Commercial Officer. Looking ahead, we expect to report new data for all three of our clinical programs this year, and continue to advance our overall business with support of our balance sheet."

Recent Highlights and Program Updates:

Upcoming Research and Development Milestones

Prothena's clinical development pipeline includes three lead protein immunotherapy programs.

NEOD001 is a monoclonal antibody that targets circulating misfolded soluble light chain and deposited insoluble amyloid for the potential treatment of AL amyloidosis:

PRX002 is a monoclonal antibody that targets á-synuclein, for the potential treatment of Parkinson's disease and related synucleinopathies, and is the primary focus of Prothena's worldwide collaboration with Roche:

PRX003 is a monoclonal antibody that targets melanoma cell adhesion molecule (MCAM), believed to be a critical mediator of Th17 cell pathogenesis, for the potential treatment of inflammatory diseases, including psoriasis:

First Quarter 2016 Financial Results and Guidance

Prothena reported a net loss of $27.5 million for the first quarter of 2016, as compared to a net loss of $15.2 million for the first quarter of 2015. Net loss per share for the first quarter of 2016 was $0.81, as compared to a net loss per share for the first quarter of 2015 of $0.55.

Prothena reported total revenue of $0.3 million for the first quarter of 2016, as compared to total revenue of $0.6 million for the first quarter of 2015. The decrease in revenue for the first quarter of 2016 was primarily due to lower revenue from Prothena's collaboration agreement with Roche.

Research and development (R&D) expenses totaled $20.5 million for the first quarter of 2016, as compared to $10.6 million for the first quarter of 2015. The increase in R&D expenses for the first quarter of 2016 was primarily due to increased expenses related to clinical trials, manufacturing, and personnel costs. R&D expenses included non-cash share-based compensation expense of $1.4 million for the first quarter of 2016, as compared to $0.8 million first quarter of 2015.

General and administrative (G&A) expenses totaled $7.2 million for the first quarter of 2016, as compared to $5.0 million for first quarter of 2015. The increase in G&A expenses for the first quarter of 2016 was primarily due to increases in personnel costs. G&A expenses included non-cash share-based compensation expense of $2.3 million in the first quarter of 2016 as compared to $0.9 million in the first quarter of 2015.

Total non-cash share-based compensation expense was $3.7 million for the first quarter of 2016, as compared to $1.7 million for the first quarter of 2015.

As of March 31, 2016, Prothena had $474.3 million in cash and cash equivalents and no debt.

As of April 22, 2016, Prothena had approximately 34.3 million ordinary shares outstanding.

The Company expects the full year 2016 net cash burn from operating and investing activities to be $105 to $115 million, ending the year with approximately $388 million in cash (midpoint). The estimated full year 2016 net cash burn from operating and investing activities is primarily driven by an estimated net loss of $132 to $149 million, which includes an estimated $18 million of non-cash share-based compensation expense.

Upcoming Investor Conferences

Members of the senior management team will present and participate in the Bank of America Merrill Lynch 2016 Health Care Conference on May 12, 2016 at 8:40 AM PT in Las Vegas, NV (11:40 AM ET).

A live webcast of the presentation can be accessed through the investor relations section of the Company's website at www.prothena.com. Following the live presentation, a replay of the webcast will be available on the Company's website for at least 90 days following the presentation date.

About Prothena

Prothena Corporation plc is a global, late-stage clinical biotechnology company seeking to fundamentally change the course of progressive diseases with its clinical pipeline of novel therapeutic antibodies. Fueled by its deep scientific understanding built over decades of research in protein misfolding and cell adhesion - the root causes of many serious or currently untreatable amyloid and inflammatory diseases - Prothena has advanced several drug candidates into clinical trials while pursuing discovery of additional novel therapies. Our clinical pipeline of antibody-based product candidates targets a number of potential indications including AL amyloidosis (NEOD001), Parkinson's disease and other related synucleinopathies (PRX002) and inflammatory diseases, including psoriasis (PRX003). For more information, please visit the company's web site at www.prothena.com.

Forward-looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the ability of our cash position to support advancement of our clinical pipeline and overall business; the potential for our Phase 2b PRONTO trial to advance our NEOD001 program; the expectation that we will be able to rapidly assess biological activity of PRX003; our potential commercial introduction of NEOD001; the timing of reporting results from the expansion cohort of our Phase 1/2 study, completing enrollment in Phase 3 VITAL study, and reporting results from the PRONTO trial, all for NEOD001; the timing of reporting data from the Phase 1 multiple ascending dose study for PRX002; the timing of reporting data from the Phase 1 single ascending dose study and the Phase 1 multiple ascending dose study for PRX003; our anticipated net cash burn from operating and investing activities for 2016 and expected cash balance at the end of 2016; and our estimated net loss and non-cash share-based compensation expense for 2016. 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 25, 2016 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)
 
 Three Months Ended March 31,
  2016
 2015
Collaboration revenue$265 $593  
Total revenue 265   593  
Operating expenses:     
Research and development 20,493   10,573  
General and administrative 7,182   5,049  
Total operating expenses 27,675   15,622  
Loss from operations (27,410)  (15,029) 
Other income, net 70   93  
Loss before income taxes (27,340)  (14,936) 
Provision for income taxes 181   266
  
Net loss$(27,521)  $(15,202) 
         
Basic and diluted net loss per share $(0.81)  $(0.55) 
Shares used to compute basic and diluted net loss per share 34,026   27,401  


 


PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
 
  
March 31,

2016

December
31,
2015
Assets  
Cash and cash equivalents  $  474,252 $  370,586 
Other current assets   7,840  6,817 
Total current assets   482,092  377,403 
Property and equipment, net   3,924  3,862 
Other assets   5,292  3,971 
Total non-current assets   9,216  7,833 
Total assets  $  491,308 $  385,236 
 Liabilities and Shareholders' Equity       
Accrued research and development  10,970  12,794 
Other current liabilities  12,264  9,422 
Total current liabilities  23,234  22,216 
Non-current liabilities:  2,294  2,351 
Total liabilities  25,528  24,567 
Total shareholders' equity  465,780  360,669 
Total liabilities and shareholders' equity $  491,308 $  385,236 


 

Contact

Investors: Tran Nguyen, CFO
650-837-8535, IR@prothena.com

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