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): August 6, 2019
_______________________________________________________
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 August 6, 2019, Prothena Corporation plc issued a press release announcing its financial results for the second quarter ended June 30, 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:
August 6, 2019
PROTHENA CORPORATION PLC
 
 
 
 
 
 
 
By:
 
/s/ Tran B. Nguyen
 
 
Name:
 
Tran B. Nguyen
 
 
Title:
 
Chief Operating Officer and Chief Financial Officer



Exhibit


Exhibit 99.1
                                                
http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=13044974&doc=3
Prothena Reports Second Quarter 2019 Financial Results and Provides R&D Update
Net cash used in operating and investing activities was $12.2 million in the second quarter and $29.7 million for the first six months of 2019; quarter-end cash and restricted cash position of $402.2 million provides funding to advance neuroscience pipeline
Appointed Paula K. Cobb to Prothena’s Board of Directors and Michael J. Malecek as Prothena’s Chief Legal Officer and Company Secretary

DUBLIN, Ireland, August 6, 2019 -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage neuroscience company, today reported financial results for the second quarter and first six months of 2019. In addition, the Company provided an update on its R&D programs.

“We remain on track to report interim clinical data from the Phase 1 study of PRX004 for ATTR amyloidosis in the fourth quarter of this year, and results from Part 1 of the PASADENA Phase 2 study of prasinezumab for Parkinson’s disease are expected in 2020,” said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. “Recently, we welcomed Paula Cobb to our Board of Directors and Mike Malecek as our Chief Legal Officer and Company Secretary. We look forward to their expertise contributing to our progress as we advance our pipeline of therapeutic candidates for devastating neurological diseases.”

Mr. Malecek’s appointment was made in conjunction with the retirement of Arthur W. ("Bill") Homan that was announced in 2018. “Since joining Prothena in 2014, Bill provided expert leadership across several business domains, and on behalf of the entire Prothena team and Board we are thankful for his significant contributions and wish him and his family all the best in his retirement,” continued Dr. Kinney.

“I am excited to join Prothena and have this uniquely rewarding opportunity to contribute as part of a team dedicated to advancing novel therapies for patients with neurological diseases,” commented Mike Malecek, Chief Legal Officer and Company Secretary of Prothena.

Second Quarter 2019 and Recent Developments
Appointed Paula K. Cobb to Prothena’s Board of Directors. Ms. Cobb is the Chief Operating Officer of Decibel Therapeutics, Inc., and has extensive global development, business strategy and commercial experience. Prior to joining Decibel in 2016, Ms. Cobb worked in a variety of global leadership roles at Biogen, including as Senior Vice President of the rare disease group, where she was responsible for the company’s marketed hemophilia assets and Phase 3 programs in spinal muscular atrophy and neuropathic pain. She served on the board of directors of Nightstar Therapeutics plc, a clinical-stage gene therapy company, until its acquisition by Biogen.

Appointed Michael J. Malecek as Chief Legal Officer and Company Secretary. Prior to joining Prothena, Mr. Malecek was Vice President and Deputy General Counsel of Intellectual Property & Litigation at Snowflake Computing. Previously, he was a Partner at the law firms of Arnold & Porter Kaye Scholer, Kaye Scholer and Dewey & LeBoeuf. In these positions he served as Managing Partner of the Silicon Valley offices and represented a range of life science companies, including Affymetrix and Complete Genomics, on intellectual





property, compliance and securities law matters. Mr. Malecek’s experience in the life science industry also includes six years as Vice President and Chief Advocacy Counsel at Affymetrix.

Upcoming Research and Development Milestones

Prothena is advancing a neuroscience pipeline of therapeutic candidates for a number of indications.

Prasinezumab (PRX002/RG7935), a potential treatment for Parkinson’s disease, is a monoclonal antibody designed to target alpha-synuclein and is the focus of a worldwide collaboration with Roche.
The Phase 2 PASADENA study in patients with early Parkinson’s disease was fully enrolled in December 2018 (N=316) and is being conducted by Roche. Data from Part 1 of the PASADENA study are expected to be announced in 2020
PRX004, a potential treatment for ATTR amyloidosis, is a monoclonal antibody designed to target and clear the pathogenic, non-native forms of the TTR protein.
The Phase 1 study of PRX004 continues to enroll patients with hATTR amyloidosis, and preliminary data from the first four of six dose level cohorts (0.1 mg/kg, 0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, 10.0 mg/kg and 30.0 mg/kg), including safety, tolerability and pharmacodynamics, as measured by Prothena’s proprietary misTTR assay, are expected to be announced in the fourth quarter of 2019
Tau is a protein implicated in diseases including Alzheimer’s disease (AD), progressive supranuclear palsy (PSP), frontotemporal dementia (FTD) and chronic traumatic encephalopathy (CTE). Prothena’s internally discovered tau antibody targets a novel epitope on the protein.
The preclinical tau program, part of a worldwide collaboration with Celgene, initiated cell line development of a lead candidate in the second quarter of this year

Second Quarter and First Six Months of 2019 Financial Results

For the second quarter and first six months of 2019, Prothena reported a net loss of $15.8 million and $36.7 million, respectively, as compared to a net loss of $59.9 million and $108.6 million for the second quarter and first six months of 2018, which included restructuring charges of $20.9 million associated with the discontinuation of the NEOD001 program. Net loss per share for the second quarter and first six months of 2019 was $0.40 and $0.92, respectively, as compared to a net loss per share of $1.50 and $2.77 for the second quarter and first six months of 2018, respectively.

Prothena reported total revenue, all from its collaboration with Roche, of $0.2 million and $0.4 million for the second quarter and first six months of 2019, respectively, as compared to total revenue of $0.3 million and $0.5 million for the second quarter and first six months of 2018, respectively.

Research and development (R&D) expenses totaled $9.6 million and $22.9 million for the second quarter and first six months of 2019, respectively, as compared to $31.5 million and $66.2 million for the second quarter and first six months of 2018, respectively. The decrease in R&D expenses for the second quarter and the first six months compared to the same periods in the prior year was primarily due to lower clinical trial costs and to a lesser extent lower product manufacturing expenses, lower personnel costs and lower consulting costs. R&D expenses included non-cash share-based compensation expense of $2.1 million and $4.2 million for the second quarter and first six months of 2019, respectively, as compared to $2.6 million and $4.8 million for the second quarter and first six months of 2018, respectively.

General and administrative (G&A) expenses totaled $9.1 million and $19.0 million for the second quarter and first six months of 2019, respectively, as compared to $11.0 million and $25.2 million for second quarter and first six months of 2018, respectively. The decrease in G&A expenses for the second quarter and the first six months compared to the same periods in the prior year was primarily due to lower personnel costs, sublease rental income and lower legal expenses. G&A expenses included non-cash share-based compensation expense of $4.2 million and $8.3 million for





the second quarter and first six months of 2019, respectively, as compared to $3.8 million and $8.4 million for the second quarter and first six months of 2018, respectively.

Total non-cash share-based compensation expense was $6.3 million and $12.5 million for the second quarter and first six months of 2019 respectively, as compared to $8.8 million and $15.7 million for the second quarter and first six months of 2018, respectively, which included $2.5 million of non-cash share-based compensation expense included in the restructuring costs.

As of June 30, 2019, Prothena had $402.2 million in cash, cash equivalents and restricted cash and no debt.

As of July 19, 2019, Prothena had approximately 39.9 million ordinary shares outstanding.

The Company continues to expect its full year 2019 net cash burn from operating and investing activities to be $57-65 million, and to end the year with approximately $371 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2019 cash burn from operating and investing activities is primarily driven by an estimated net loss of $83-94 million, which includes an estimated $24 million of non-cash shared-based compensation expense.

About Prothena
Prothena Corporation plc is a clinical-stage neuroscience company focused on the discovery and development of novel therapies with the potential to fundamentally change the course of devastating neurological disorders. Fueled by its deep scientific understanding built over decades of neuroscience research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets including Parkinson’s disease and other related synucleinopathies (prasinezumab - PRX002/RG7935, in collaboration with Roche) and ATTR amyloidosis (PRX004), as well as tau and TDP-43 (both programs in collaboration with Celgene) for which 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 on Twitter @ProthenaCorp.

Forward-looking Statements
This press release contains forward-looking statements. These statements relate to, among other things: the sufficiency of our funding to advance our neuroscience pipeline; our expected timing of reporting interim data from the Phase 1 study of PRX004 and the expected scope of that data; our expected timing of reporting data from the Phase 2 PASADENA study of prasinezumab; the design of prasinezumab and its potential as a treatment for Parkinson’s disease; the design of PRX004 and its potential as a treatment for ATTR amyloidosis; our goal of advancing a neuroscience pipeline of therapeutic candidates for a number of indications; our expected net cash burn from operating and investing activities in 2019 and cash balance at the end of 2019; and our estimated net loss and non-cash share-based compensation expense for 2019. 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) March 15, 2019 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 June 30,
 
Six Months Ended
June 30,
 
 
2019
 
2018
 
2019
 
2018
Collaboration revenue
 
$
167

 
$
279

 
$
353

 
$
506

Total revenue
 
167

 
279

 
353

 
506

Operating expenses:
 
 
 
 
 
 
 
 
Research and development
 
9,583

 
31,452

 
22,879

 
66,158

General and administrative
 
9,081

 
10,992

 
18,986

 
25,221

Restructuring charges (credits)
 

 
20,904

 
(61
)
 
20,904

Total operating expenses
 
18,664

 
63,348

 
41,804

 
112,283

Loss from operations
 
(18,497
)
 
(63,069
)
 
(41,451
)
 
(111,777
)
Other income, net
 
2,531

 
1,241

 
4,818

 
1,169

Loss before income taxes
 
(15,966
)
 
(61,828
)
 
(36,633
)
 
(110,608
)
Provision for (benefit from) income taxes
 
(156
)
 
(1,946
)
 
42

 
(1,983
)
Net loss
 
$
(15,810
)
 
$
(59,882
)
 
$
(36,675
)
 
$
(108,625
)
Basic and diluted net loss per share
 
$
(0.40
)
 
$
(1.50
)
 
$
(0.92
)
 
$
(2.77
)
Shares used to compute basic and diluted net loss per share
 
39,872

 
39,824

 
39,868

 
39,257







PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
 
June 30,
 
December 31,
 
2019
 
2018
Assets
 
 
 
Cash and cash equivalents
$
398,144

 
$
427,659

Restricted cash, current
1,352

 

Prepaid expenses and other current assets
19,212

 
3,731

Total current assets
418,708

 
431,390

Property and equipment, net
4,318

 
52,835

Operating lease right-of-use assets
25,927

 

Restricted cash, non-current
2,704

 
4,056

Other non-current assets
10,415

 
10,515

Total non-current assets
43,364

 
67,406

Total assets
$
462,072

 
$
498,796

Liabilities and Shareholders’ Equity
 
 
 
Accrued research and development
$
2,260

 
$
5,370

Restructuring liability

 
461

Lease liability, current
4,904

 

Other current liabilities
20,852

 
9,095

Total current liabilities
28,016

 
14,926

Deferred revenue
110,242

 
110,242

Lease liability, non-current
20,454

 

Other non-current liabilities
553

 
50,630

     Total non-current liabilities
131,249

 
160,872

Total liabilities
159,265

 
175,798

Total shareholders’ equity
302,807

 
322,998

Total liabilities and shareholders’ equity
$
462,072

 
$
498,796



Media and Investor Contact:

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