Document


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_______________________________________________________
FORM 8-K 
_______________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 12, 2020
_______________________________________________________
PROTHENA CORPORATION PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter)
_______________________________________________________
 
 
 
 
 
Ireland
 
001-35676
 
98-1111119
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
 
77 Sir John Rogerson's Quay, Block C
Grand Canal Docklands
Dublin 2, D02 T804, Ireland
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: 011-353-1-236-2500
___________________________________________________
(Former Name or Former Address, if Changed Since Last Report.) 
___________________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Trading Symbol
Name of Each Exchange on Which Registered
Ordinary Shares, par value $0.01 per share
PRTA
The Nasdaq Global Select Market






Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o






Item 2.02.
Results of Operations and Financial Condition.
The information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically incorporate by reference the information furnished pursuant to Item 2.02 (including Exhibit 99.1) of this Current Report.
On February 12, 2020, Prothena Corporation plc issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 31, 2019. A copy of that press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01.
Financial Statements and Exhibits
(d) Exhibits.
 
 
 
Exhibit No.
 
Description
99.1
 


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date:
February 12, 2020
PROTHENA CORPORATION PLC
 
 
 
 
 
 
 
By:
 
/s/ Tran B. Nguyen
 
 
Name:
 
Tran B. Nguyen
 
 
Title:
 
Chief Operating Officer and Chief Financial Officer



Exhibit


Exhibit 99.1
                                                
https://cdn.kscope.io/f70f02bc370d820a1c05aa4690fced23-prothenargbfullcolora15.jpg
Prothena Reports Fourth Quarter and Full Year 2019 Financial Results, and Provides Financial Guidance and R&D Update
Net cash used in operating and investing activities was $14.6 million in the fourth quarter and $53.5 million for the full year 2019; quarter-end cash and restricted cash position of $378.4 million provides funding to advance a broad pipeline
Reported interim data from Phase 1 study of PRX004 in patients with hereditary ATTR amyloidosis

DUBLIN, Ireland, Feb. 12, 2020-- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage neuroscience company with expertise in protein misfolding, today reported financial results for the fourth quarter and full year 2019. In addition, the Company provided 2020 financial guidance and an update on its R&D programs.
“In 2019, we continued to advance our pipeline of novel investigational therapeutics towards key milestones,” said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. “We reported interim data from our first-in-human Phase 1 study of PRX004 in patients with hereditary ATTR amyloidosis and continue to expect data from Part 1 of the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson’s disease this year. Looking ahead, we have expanded our innovative discovery and preclinical pipeline which consists of three targets under our global neuroscience collaboration with Bristol-Myers Squibb, as well as our proprietary preclinical and discovery programs that comprise our Alzheimer’s disease portfolio.”

Full Year 2019 and Recent Developments:
Prasinezumab (PRX002/RG7935), a potential treatment for Parkinson’s disease, is a monoclonal antibody designed to target alpha-synuclein and is the focus of the worldwide collaboration with Roche
Completed last patient visit in part 1 of the two-part Phase 2 PASADENA study being conducted by Roche in patients with early Parkinson’s disease (N=316).
PRX004, a potential treatment for ATTR amyloidosis, is a monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein
Reported interim data from the first-in-human dosing in a Phase 1 clinical study of PRX004 in patients with hereditary ATTR (hATTR) amyloidosis. In the interim analysis, 15 patients in the dose escalation phase of the study each received 3 infusions in dose-level cohorts 1 through 5 representing 0.1, 0.3, 1.0, 3.0 and 10.0 mg/kg. PRX004 was found to be generally safe and well tolerated and demonstrated pharmacokinetic profiles consistent with that of an immunoglobulin gamma 1 (IgG1) monoclonal antibody. Target engagement was demonstrated by a dose-dependent decrease in plasma levels of misTTR (the non-native forms of TTR), as measured by our proprietary misTTR biomarker assay. For the three patients in the 10.0 mg/kg dose-level (the highest dose-level in the interim analysis), the maximum observed reductions in misTTR levels occurred within 24 hours of the first infusion were 54%, 66% and 76%. As expected, because PRX004 was designed to recognize an epitope exposed only on the misTTR species, PRX004 did not appear to impact levels of normal tetrameric TTR.





Discovery and Preclinical Development: Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications
Initiated cell line development of a lead candidate in the preclinical tau program, part of a worldwide collaboration with Bristol-Myers Squibb, in the second quarter of 2019.
Initiated cell line development of a lead candidate in the proprietary preclinical Aβ (Amyloid beta) program in the fourth quarter of 2019.

Corporate
Appointed Paula Cobb to the Board of Directors. Ms. Cobb is a biotechnology executive with wide-ranging global development, business strategy and commercial experience across a number of categories. She is the former Chief Operating Officer of Decibel Therapeutics and held several senior global leadership positions at Biogen, including as Senior Vice President of the rare disease group.

Appointed Oleg Nodelman to the Board of Directors. With more than 20 years of biotech investing experience, Mr. Nodelman is a veteran biotechnology investor and advisor with deep roots in the biotechnology and scientific communities. He is the founder and portfolio manager of EcoR1 Capital LLC, a biotech-focused investment advisory firm established in 2013. Before founding EcoR1, Mr. Nodelman was a portfolio manager at BVF Partners, one of the first hedge funds dedicated to the biotechnology sector.

Upcoming Research and Development Milestones
Prasinezumab
The Phase 2 PASADENA study in patients with early Parkinson’s disease (N=316) is being conducted by Roche, and data from Part 1 of this study are expected to be reported in 2020
PRX004
Interim data from the ongoing Phase 1 study was reported in December 2019, and additional data from the dose-escalation and long-term extension portions of the study are expected to be reported in 2020
Preclinical
The preclinical tau program, part of a global neuroscience collaboration with Bristol-Myers Squibb, is expected to advance IND-enabling activities in 2020
The preclinical Aβ program is expected to initiate IND-enabling studies in 2020

Fourth Quarter and Full Year of 2019 Financial Results and 2020 Financial Guidance

For the fourth quarter and full year of 2019, Prothena reported a net loss of $21.6 million and $77.7 million, respectively, as compared to a net loss of $22.5 million and $155.6 million for the fourth quarter and full year of 2018, respectively, which included a restructuring credit of $1.6 million in the fourth quarter of 2018 and restructuring charges of $16.1 million for the full year of 2018 associated with the discontinuation of the NEOD001 program. Net loss per share for the fourth quarter and full year of 2019 was $0.54 and $1.95, respectively, as compared to a net loss per share of $0.56 and $3.93 for the fourth quarter and full year of 2018, respectively.

Prothena reported total revenue, all from its collaboration with Roche, of $0.3 million and $0.8 million for the fourth quarter and full year of 2019, respectively, as compared to total revenue of $0.2 million and $1.0 million for the fourth quarter and full year of 2018, respectively.

Research and development (R&D) expenses totaled $15.5 million and $50.8 million for the fourth quarter and full year of 2019, respectively, as compared to $16.5 million and $101.2 million for the fourth quarter and full year of





2018, respectively. The decrease in R&D expense for the fourth quarter of 2019 compared to the same period in the prior year was primarily due to lower intellectual property license expense, lower clinical costs (primarily associated with the discontinuation of the NEOD001 program partially offset by higher costs for the PRX004 program) and lower personnel costs (including share-based compensation expense); offset in part by higher collaboration expense with Roche. The decrease in R&D expense for the full year ended 2019 compared to the same period in the prior year was primarily due to lower clinical costs (primarily associated with the discontinuation of the NEOD001 program partially offset by higher costs for the PRX004 program), lower personnel costs (including share-based compensation expense), lower consulting costs and lower manufacturing costs (primarily associated with the discontinuation of the NEOD001 program and to a lesser extent to declines from the PRX004 program, offset in part by increase in cost for the tau program). R&D expenses included non-cash share-based compensation expense of $2.0 million and $8.1 million for the fourth quarter and full year of 2019, respectively, as compared to $2.1 million and $9.8 million for the fourth quarter and full year of 2018, respectively.

General and administrative (G&A) expenses totaled $8.1 million and $35.7 million for the fourth quarter and full year of 2019, respectively, as compared to $8.0 million and $42.5 million for fourth quarter and full year of 2018, respectively. G&A expenses for the fourth quarter of 2019 increased slightly compared to the same period in the prior year primarily related to higher lease cost recorded as operating expenses due to the adoption of the new lease standard (ASC 842) and higher directors and officer’s insurance largely offset by other G&A cost. The decrease in G&A expenses for the full year of 2019 compared to the same period in the prior year was primarily due to lower personnel costs (including share-based compensation expense), receipt of sublease rental income, lower legal and accounting fees, lower depreciation and other expenses; offset in part by higher lease costs recorded as operating expenses due to the adoption of ASC 842. G&A expenses included non-cash share-based compensation expense of $3.3 million and $15.5 million for the fourth quarter and full year of 2019, respectively, as compared to $3.7 million and $16.2 million for the fourth quarter and full year of 2018, respectively.
Restructuring credit was nil and $0.1 million for the fourth quarter and full year of 2019, respectively, as compared to $1.6 million for the fourth quarter of 2018 and restructuring charges of $16.1 million for the full year of 2018. The restructuring credit in 2019 was primarily the result of an adjustment in previously recorded employee termination benefits.
Total non-cash share-based compensation expense was $5.3 million and $23.6 million for the fourth quarter and full year of 2019, respectively, as compared to $4.2 million and $27.0 million for the fourth quarter and full year of 2018, respectively, which included a $1.6 million share-based compensation credit and $0.9 million share-based compensation expense included in the restructuring costs for the fourth quarter of 2018 and the full year of 2018, respectively.
As of December 31, 2019, Prothena had $378.4 million in cash, cash equivalents and restricted cash and no debt.

As of February 7, 2020, Prothena had approximately 39.9 million ordinary shares outstanding.

The Company expects its full year 2020 net cash burn from operating and investing activities to be $60-$76 million, and to end the year with approximately $310 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2020 cash burn from operating and investing activities is primarily driven by an estimated net loss of $84-$106 million, which includes an estimated $23 million of non-cash shared-based compensation expense.

Conference Call Details
Prothena management will discuss these results and its 2020 financial guidance during a live audio conference call today, Wednesday, February 12, 2020, at 4:30 PM ET. The conference call will be made available on the Company's website at www.prothena.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay will be available on the Company's website for at least 90 days.
To access the call via dial-in, please dial (877) 887-5215 (U.S. and Canada toll free) or (315) 625-3069 (international) five minutes prior to the start time and refer to conference ID number 1758808. A replay of the call will be available until February 26, 2020 via dial-in at (855) 859-2056 (U.S. toll free) or (404) 537-3406 (international), Conference ID Number 1758808.






About Prothena
Prothena Corporation plc is a clinical-stage neuroscience company with expertise in protein misfolding, focused on the discovery and development of novel therapies with the potential to fundamentally change the course of devastating diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s partnered programs include prasinezumab (PRX002/RG7935), in collaboration with Roche for the potential treatment of Parkinson’s disease and other related synucleinopathies, and programs that target tau, TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD) or other neurodegenerative diseases. Our proprietary programs include PRX004 for the potential treatment of ATTR amyloidosis, and programs that target Aβ (Amyloid beta) for the potential treatment of Alzheimer’s disease.
For more information, please visit the Company’s website at www.prothena.com and follow us on Twitter @ProthenaCorp.

Forward-looking Statements
This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash position to fund advancement of a broad pipeline; the treatment potential and proposed mechanisms of action of prasinezumab and PRX004; the expected timing of reporting data from the Phase 1 clinical study of PRX004; the expected timing of reporting data from the Phase 2 clinical study of prasinezumab; the continued advancement of our discovery and preclinical pipeline; and the timing of IND-enabling activities from our tau and programs; our anticipated net cash burn from operating and investing activities for 2020 and expected cash balance at the end of 2020; and our estimated net loss and non-cash share-based compensation expense for 2020. 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 March 15, 2019, our subsequent Quarterly Reports on Form 10-Q filed with the SEC and our Annual Report on Form 10-K to be filed with the SEC for our fiscal year 2019. 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 December 31,
 
Twelve Months Ended December 31,
 
 
2019
 
2018
 
2019
 
2018
Collaboration revenue
 
$
256

 
$
194

 
$
814

 
$
955

Total revenue
 
256

 
194

 
814

 
955

Operating expenses:
 
 
 
 
 
 
 
 
Research and development
 
15,471

 
16,510

 
50,836

 
101,183

General and administrative
 
8,059

 
8,026

 
35,736

 
42,482

Restructuring and related impairment charges (credits)
 

 
(1,587
)
 
(61
)
 
16,145

Total operating expenses
 
23,530

 
22,949

 
86,511

 
159,810

Loss from operations
 
(23,274
)
 
(22,755
)
 
(85,697
)
 
(158,855
)
Other income, net
 
1,589

 
845

 
8,399

 
2,740

Loss before income taxes
 
(21,685
)
 
(21,910
)
 
(77,298
)
 
(156,115
)
Provision for (benefit from) income taxes
 
(131
)
 
551

 
379

 
(470
)
Net loss
 
$
(21,554
)
 
$
(22,461
)
 
$
(77,677
)
 
$
(155,645
)
Basic and diluted net loss per share
 
$
(0.54
)
 
$
(0.56
)
 
$
(1.95
)
 
$
(3.93
)
Shares used to compute basic and diluted net loss per share
 
39,897

 
39,864

 
39,882

 
39,559







PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
 
December 31,
 
2019
 
2018
Assets
 
 
 
Cash and cash equivalents
$
375,723

 
$
427,659

Prepaid expenses and other current assets
2,652

 
3,731

Total current assets
378,375

 
431,390

Property and equipment, net
3,874

 
52,835

Operating lease right-of-use assets
23,274

 

Restricted cash, non-current
2,704

 
4,056

Other non-current assets
11,041

 
10,515

Total non-current assets
40,893

 
67,406

Total assets
$
419,268

 
$
498,796

Liabilities and Shareholders’ Equity
 
 
 
Accrued research and development
$
5,826

 
$
5,370

Restructuring liability

 
461

Lease liability, current
5,101

 

Other current liabilities
6,787

 
9,095

Total current liabilities
17,714

 
14,926

Deferred revenue
110,242

 
110,242

Lease liability, non-current
17,838

 

Other non-current liabilities
553

 
50,630

     Total non-current liabilities
128,633

 
160,872

Total liabilities
146,347

 
175,798

Total shareholders’ equity
272,921

 
322,998

Total liabilities and shareholders’ equity
$
419,268

 
$
498,796



Media and Investor Contact:

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