Prothena Corporation plc
Prothena Corp plc (Form: 8-K, Received: 05/05/2015 16:16:28)


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): May 5, 2015
_______________________________________________________

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.)
 
 
 
Alexandra House
The Sweepstakes, Ballsbridge
Dublin 4, Ireland
(Address of principal executive offices including Zip Code)
Registrant’s telephone number, including area code: 011-353-1-902-3519
(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))





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 May 5, 2015 , Prothena Corporation plc issued a press release announcing the Company's financial results for the first quarter ended March 31, 2015 . A copy of this press release entitled “Prothena Reports First Quarter 2015 Financial Results and Provides R&D Update” 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
 
Press Release dated May 5, 2015.


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:
May 5, 2015
PROTHENA CORPORATION PLC
 
 
 
 
 
 
 
By:
 
/s/ Tran B. Nguyen
 
 
Name:
 
Tran B. Nguyen
 
 
Title:
 
Chief Financial Officer





Exhibit 99.1
                                                
Prothena Reports First Quarter 2015 Financial Results and Provides R&D Update

Net cash used in operating activities was $14.7 million in the first quarter; net proceeds of $131.4 million raised through April 2015 public equity offering added to $279.9 million quarter-end cash position provide solid runway for continued advancement of multiple programs
Reported positive results from a Phase 1 single ascending dose study of PRX002, a novel protein immunotherapy for Parkinson’s disease, demonstrating robust, rapid and dose-dependent mean reduction of free serum alpha-synuclein of up to 96% after single dose

DUBLIN, Ireland - May 5, 2015 - Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, today reported financial results for the first quarter ended March 31, 2015 and provided an update on its lead programs.

“During the first quarter, we reported positive Phase 1 data confirming that PRX002 was safe and well tolerated, and importantly, that a single dose of PRX002 resulted in robust, rapid and dose-dependent mean reduction of free serum alpha-synuclein of up to 96%. Reducing alpha-synuclein may translate into a delay or reversal of disease progression in patients with Parkinson's disease,” said Dale Schenk, PhD, President and Chief Executive Officer of Prothena. “Taken in combination with the Phase 1/2 results for NEOD001 that drove the initiation of The VITAL Amyloidosis Study, our global Phase 3 registrational trial, today we have a multi-product pipeline of potentially disease-modifying immunotherapies.”

Dr. Schenk continued, “Further, PRX003 is expected to enter the clinic in the first half of this year, and we believe we are exceptionally well capitalized for sustainable development growth and for becoming a commercial company in the years ahead.”

First Quarter 2015 and Recent Highlights
In March, reported positive results from the Phase 1 single ascending dose study for PRX002 in healthy volunteers
PRX002 was safe and well tolerated at all doses, meeting the primary objective of the study
PRX002 demonstrated favorable pharmacokinetic properties, supporting the current dosing frequency in the ongoing Phase 1 multiple ascending dose study in patients with Parkinson's disease
Results showed that a single administration of PRX002 leads to a robust, rapid and dose-dependent mean reduction of free serum alpha-synuclein levels of up to 96% (p<0.00001)
In April, raised aggregate net proceeds of $131.4 million through the issuance of 3,795,000 ordinary shares
In May, announced an agreement with The Michael J. Fox Foundation for Parkinson’s Research to accelerate the discovery and development of novel biomarkers for Parkinson’s disease that facilitate therapeutic approaches targeting alpha-synuclein, including PRX002






Upcoming Research and Development Pipeline Milestones

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

NEOD001 is a monoclonal antibody for the potential treatment of AL amyloidosis :
Enrolling patients with AL amyloidosis and cardiac dysfunction in The VITAL Amyloidosis Study, a global Phase 3 registrational trial
Expect additional data from the Phase 1/2 study in patients with AL amyloidosis and persistent organ dysfunction to be shared at least once annually at a medical conference

PRX002 is a monoclonal antibody for the potential treatment of Parkinson's disease and other related synucleinopathies, and is the primary focus of Prothena's worldwide collaboration with Roche:
Expect to share further details on positive results from Phase 1 single ascending dose study at a medical conference in 2015
Expect topline data from Phase 1 multiple ascending dose study in patients with Parkinson’s disease in the first half of 2016

PRX003 is a monoclonal antibody for the potential treatment of psoriasis and other inflammatory diseases:
Expect to initiate Phase 1 single ascending dose trial in healthy volunteers in the second quarter of 2015
Expect to initiate Phase 1 multiple ascending dose study in patients with psoriasis in 2016

First Quarter 2015 Financial Results and Guidance

Prothena reported a net loss of $15.2 million for the first quarter of 2015 as compared to net income of $17.9 million for the first quarter of 2014. Net loss per share was $0.55 for the first quarter of 2015 as compared to net income per share of $0.78 on a fully diluted basis for the first quarter of 2014.

Prothena reported total revenue of $0.6 million for the first quarter of 2015 as compared to total revenue of $32.2 million for the first quarter of 2014. The decrease was primarily due to $32.1 million in collaboration revenue recognized in relation to the PRX002 collaboration with Roche in the first quarter of 2014 compared to $0.6 million in collaboration revenue recognized in the first quarter of 2015.

Research and development (R&D) expenses totaled $10.6 million for the first quarter of 2015 as compared to $9.3 million for the first quarter of 2014. The increase in R&D expenses was primarily due to increased external expenses related to clinical trials, and higher personnel costs offset by lower external product manufacturing expenses and higher net expense reimbursements from Roche. R&D expenses included non-cash share-based compensation expense of $0.8 million for the first quarter of 2015 as compared to $0.5 million for the first quarter of 2014.

General and administrative (G&A) expenses totaled $5.0 million for the first quarter of 2015 as compared to $4.9 million for first quarter of 2014. The increase in G&A expenses was primarily due to increases in personnel costs. G&A expenses included non-cash share-based compensation expense of $0.9 million in both the first quarter of 2015 and the first quarter of 2014.

Total non-cash share-based compensation expense was $1.7 million for the first quarter of 2015 as compared to $1.3 million for the first quarter of 2014.






As of March 31, 2015, Prothena had $279.9 million in cash and cash equivalents and no outstanding debt. In April 2015, Prothena raised net proceeds of $131.4 million through a public offering of 3.8 million ordinary shares. After completion of that offering and as of April 24, 2015, Prothena had 31.3 million ordinary shares outstanding.

The Company expects the full year 2015 net cash burn from operating and investing activities to be $66 to $72 million, ending the year with approximately $356 million in cash (mid-point). The estimated full year 2015 net cash burn from operating and investing activities is primarily driven by an estimated net loss of $77 to $83 million, which includes an estimated $9 million of non-cash share-based compensation expense.

Upcoming Investor Conferences

Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:

Credit Suisse’s Antibody Day on Wednesday, May 6, 2015 at 12:05 p.m. EDT in New York, NY
Bank of America Merrill Lynch 2015 Health Care Conference on Wednesday, May 13, 2015 at 1:40 p.m. PDT at Encore at the Wynn in Las Vegas, NV
UBS 2015 Global Healthcare Conference on Monday, May 18, 2015 at 10:00 a.m. EDT at Sheraton Times Square Hotel in New York, NY

Live webcasts of the above presentations can be accessed through the investor relations section of the Company's website at www.prothena.com. Following the live presentations, replays of the webcasts will be available on the Company's website for 90 days following the presentation date.

About Prothena

Prothena Corporation plc is a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs for the potential treatment of diseases that involve amyloid or cell adhesion. The Company is developing antibody-based product candidates that target a number of potential indications including AL amyloidosis (NEOD001), Parkinson's disease and other related synucleinopathies (PRX002), and psoriasis and other inflammatory diseases (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 fund continued advancement of our program and becoming a commercial company; the potential for PRX002 to impact Parkinson’s disease progression; the potential for our programs to be disease-modifying; the enrollment for our VITAL Amyloidosis Study for NEOD001; the timing of reporting additional data from our ongoing Phase 1/2 study for NEOD001; the timing of reporting further data from our Phase 1 single ascending dose study and initial data from our Phase 1 multiple ascending dose study for PRX002; the timing of initiating our Phase 1 single ascending dose and multiple ascending dose studies for PRX003; our anticipated net cash burn from operating and investing activities for 2015 and expected cash balance at the end of 2015; and our estimated net loss and non-cash share-based compensation expense for 2015. 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 13, 2015 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,
 
 
2015
 
2014
Collaboration revenue
 
$
593

 
$
32,096

Revenue—related party
 

 
138

Total revenue
 
593

 
32,234

Operating expenses:
 
 
 
 
Research and development
 
10,573

 
9,342

General and administrative
 
5,049

 
4,873

Total operating expenses
 
15,622

 
14,215

Income (loss) from operations
 
(15,029
)
 
18,019

Other income (expense), net
 
93

 
(16
)
Income (loss) before income taxes
 
(14,936
)
 
18,003

Provision for income taxes
 
266

 
151

Net income (loss)
 
$
(15,202
)
 
$
17,852

Net income (loss) per share attributable to holders of ordinary shares
 
 
 
 
Basic
 
$
(0.55
)
 
$
0.82

Diluted
 
$
(0.55
)
 
$
0.78

Shares used to compute net income (loss) per share attributable to holders of ordinary shares
 
 
 
 
Basic
 
27,401

 
21,884

Diluted
 
27,401

 
22,942








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


 
March 31,
 
December 31,
 
2015
 
2014
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
279,857

 
$
293,579

Receivable from Roche
1,357

 
1,729

Receivable from related party
30

 
30

Deferred tax assets
163

 
167

Prepaid expenses and other current assets
3,012

 
3,770

Total current assets
284,419

 
299,275

Non-current assets:
 
 
 
Property and equipment, net
2,956

 
3,121

Deferred tax assets, non-current
2,093

 
1,720

Other assets
117

 

Total non-current assets
5,166

 
4,841

Total assets
$
289,585

 
$
304,116

Liabilities and Shareholders’ Equity
 
 
 
Accrued research and development
3,662

 
2,285

Other current liabilities
5,882

 
9,754

Total current liabilities
9,544

 
12,039

Non-current liabilities
2,615

 
2,188

Total liabilities
12,159

 
14,227

Total shareholders’ equity
277,426

 
289,889

Total liabilities and shareholders’ equity
$
289,585

 
$
304,116



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

Media: Angela Bitting
925-202-6211, angela.bitting@prothena.com