0001559053FALSE00015590532024-11-122024-11-12

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): November 12, 2024
_______________________________________________________
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 VK60, 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):
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐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 ClassTrading SymbolName of Each Exchange on Which Registered
Ordinary Shares, par value $0.01 per sharePRTAThe 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 ☐



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. ☐



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 November 12, 2024, Prothena Corporation plc issued a press release announcing its financial results for the third quarter ended September 30, 2024. 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
104Cover Page Interactive Data File (embedded within the Inline XBRL document)


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: November 12, 2024PROTHENA CORPORATION PLC
By: /s/ Tran B. Nguyen
Name: Tran B. Nguyen
Title: Chief Financial Officer and Chief Strategy Officer


Exhibit 99.1
                                                
prothenalogo.jpg
PRESS RELEASE


Prothena Reports Third Quarter 2024 Financial Results and Business Highlights

•Net cash used in operating and investing activities was $102.5 million and $102.5 million for the third quarter and first nine months of 2024, respectively; quarter-end cash and restricted cash position was $520.1 million
•PRX012, a potential single-injection once-monthly subcutaneous treatment, is designed to address the unmet need of millions of patients with presymptomatic or early symptomatic Alzheimer's disease; Prothena expects to report multiple clinical readouts starting in mid-2025 and continuing throughout the year from the ongoing Phase 1 ASCENT clinical trials
•Results from partner Roche evaluating prasinezumab in patients with early Parkinson’s disease from the Phase 2 PASADENA OLE clinical trial published in Nature Medicine
•In collaboration with Bristol Myers Squibb, Prothena has initiated a Phase 1 clinical trial for PRX019, a potential treatment for neurodegenerative diseases
•With partner Novo Nordisk, Phase 1 clinical trial results for coramitug (formerly PRX004) in patients with ATTR amyloidosis published in Amyloid, the official journal of the ISA
•Prothena appointed Chad J. Swanson, Ph.D., as Chief Development Officer

DUBLIN, Ireland, November 12, 2024-- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today reported financial results for the third quarter and first nine months of 2024 and provided business highlights.

“Within the next several quarters we expect meaningful data readouts on four clinical programs in our robust R&D pipeline, that have the potential to significantly improve the lives of millions of individuals with neurodegenerative or rare peripheral amyloid diseases and their families,” said Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena. “From our wholly-owned programs we expect to complete our confirmatory Phase 3 AFFIRM-AL clinical trial evaluating birtamimab, which is being conducted under a SPA agreement with the FDA at a significance level of 0.10, in 1H 2025. We also expect to announce multiple clinical readouts from our ongoing Phase 1 ASCENT clinical trials evaluating PRX012 for Alzheimer’s disease starting in mid-2025 and continuing throughout the year. In collaboration with Roche, we expect results from the Phase 2b PADOVA clinical trial evaluating prasinezumab for Parkinson’s disease in 4Q 2024 and with Novo Nordisk, we expect results from the Phase 2 signal-detection clinical trial evaluating coramitug for ATTR amyloidosis with cardiomyopathy in 1H 2025.”



Third Quarter, Recent Business Highlights and Upcoming Milestones

Neurodegenerative Diseases Portfolio

Alzheimer’s Disease

PRX012, a wholly-owned potential best-in-class, single-injection once-monthly antibody delivered subcutaneously for the treatment of Alzheimer’s disease that targets a key epitope at the N-terminus of amyloid beta (Aβ) with high binding potency. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PRX012 for the treatment of Alzheimer’s disease.
•Designed as a potential single-injection once-monthly subcutaneous treatment to address the unmet need of millions of patients with presymptomatic or early symptomatic Alzheimer's disease, Prothena expects to report multiple clinical readouts starting in mid-2025 and continuing throughout the year from the ongoing Phase 1 ASCENT clinical trials
•Prothena has currently enrolled approximately 260 patients in the ASCENT clinical trials
•Poster presentation at CTAD 2024 highlighted the clinical trial design and patient demographic diversity of the ongoing ASCENT clinical trials

BMS-986446 (formerly PRX005), a potential best-in-class antibody for the treatment of Alzheimer’s disease that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in the causal pathophysiology of Alzheimer’s disease.
•Bristol Myers Squibb continues to enroll the ongoing Phase 2 clinical trial in approximately 475 patients with early Alzheimer’s disease; primary completion expected in 2027 (NCT06268886)
•Bristol Myers Squibb is responsible for all development, manufacturing, and commercialization
•Oral encore presentation by partner Bristol Myers Squibb at CTAD 2024 highlighted the design of the ongoing Phase 2 TargetTau-1 clinical trial

PRX123, a wholly-owned potential first-in-class dual Aβ/tau vaccine designed for the treatment and prevention of Alzheimer’s disease, is a dual-target vaccine targeting key epitopes within the N-terminus of Aβ and MTBR-tau designed to promote amyloid clearance and block the transmission of pathogenic tau. The FDA cleared the investigational new drug (IND) application and granted Fast Track designation for PRX123 for the treatment of Alzheimer’s disease.
•Continuing to optimize capital allocation across our robust R&D pipeline, Prothena expects to update plans for Phase 1 clinical trial in 2025

Parkinson’s Disease

Prasinezumab, a potential first-in-class antibody for the treatment of Parkinson’s disease that is designed to target key epitopes within the C-terminus of alpha-synuclein and is the focus of a worldwide collaboration with Roche.
•PASADENA Open Label Extension Phase 2 clinical trial results published in Nature Medicine showed a continued reduction in motor and functional progression compared to real-world data after 4 years
•Topline results from Phase 2b PADOVA clinical trial in patients with early Parkinson’s disease, which has completed enrollment of 586 patients, expected in 4Q 2024 (NCT04777331)



Neurodegenerative Diseases

PRX019, a potential treatment of neurodegenerative diseases in development in collaboration with Bristol Myers Squibb.
•Prothena has initiated a Phase 1 first-in-human clinical trial to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of single ascending and multiple doses in healthy adults

Rare Peripheral Amyloid Diseases Portfolio

AL Amyloidosis

Birtamimab, a wholly-owned potential best-in-class anti-amyloid antibody for the treatment of AL amyloidosis designed to directly neutralize soluble toxic light chain aggregates and promote clearance of amyloid that causes organ dysfunction and failure. Among patients with AL amyloidosis, a rare, progressive, and fatal disease, newly diagnosed individuals with cardiac involvement are at the highest risk for early death. Birtamimab has been granted Fast Track designation by the FDA and has been granted Orphan Drug Designation by both the FDA and European Medicines Agency. A significant survival benefit was observed in the post hoc analysis of birtamimab-treated patients categorized as Mayo Stage IV at baseline in the previous Phase 3 VITAL clinical trial (Blood 2023).
•The ongoing confirmatory Phase 3 AFFIRM-AL clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA with a primary endpoint of all-cause mortality (time-to-event) at a significance level of 0.10
•Topline results from confirmatory AFFIRM-AL Phase 3 clinical trial expected in 1H 2025 (NCT04973137)

ATTR Amyloidosis

Coramitug (formerly PRX004), a potential first-in-class amyloid depleter antibody for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM) designed to deplete the pathogenic, non-native forms of the transthyretin (TTR) protein, is being developed by Novo Nordisk as part of its up to $1.2 billion acquisition of Prothena’s ATTR amyloidosis business and pipeline.
•Phase 1 clinical trial results for coramitug in patients with ATTR amyloidosis published in Amyloid, the official journal of the International Society of Amyloidosis
•Ongoing Phase 2 signal-detection clinical trial in patients with ATTR-CM is being conducted by Novo Nordisk
•Phase 2 clinical trial has completed enrollment of approximately 99 patients with topline data expected in 1H 2025 (NCT05442047)

Corporate Highlight

•Prothena announced the appointment of Chad J. Swanson, Ph.D., as Chief Development Officer in September 2024, leading all clinical development and medical functions. Dr. Swanson is a neuropharmacologist with over 20 years industry experience and joined Prothena as Senior Vice President and Head of Clinical Development in January 2023 from Eisai, Inc. where he was the Executive Director of Clinical Research in the Alzheimer’s Disease Brain Health group.



Third Quarter and First Nine Months of 2024 Financial Results
For the third quarter and first nine months of 2024, Prothena reported net loss of $59.0 million and $64.4 million, respectively, as compared to a net income of $21.9 million and net loss of $79.6 million for the third quarter and first nine months of 2023, respectively. Net loss per share was $1.10 and $1.20 for the third quarter and first nine months of 2024, as compared to a net income per share on a diluted basis of $0.38 and a net loss per share of $1.50 for the third quarter and first nine months of 2023, respectively.
Prothena reported total revenue of $1.0 million and $133.0 million for the third quarter and first nine months of 2024, respectively, as compared to total revenue of $84.9 million and $91.1 million for the third quarter and first nine months of 2023, respectively. Total revenue for the third quarter and first nine months of 2024 was primarily from collaboration revenue from Bristol Myers Squibb as compared to total revenue for the third quarter and first nine months of 2023 that was also primarily from collaboration revenue from Bristol Myers Squibb.
Research and development (R&D) expenses totaled $50.7 million and $172.3 million for the third quarter and first nine months of 2024, respectively, as compared to $57.9 million and $158.7 million for the third quarter and first nine months of 2023, respectively. The decrease in R&D expenses for the third quarter compared to the same period in the prior year was primarily due to lower manufacturing expenses. The increase in R&D expenses for the first nine months of 2023, compared to the same period in the prior year was primarily due to higher clinical trial expenses and higher personnel related expenses; offset in part by lower manufacturing and other R&D expenses. R&D expenses included non-cash share-based compensation expense of $5.1 million and $16.2 million for the third quarter and first nine months of 2024, respectively, as compared to $4.9 million and $14.2 million for the third quarter and first nine months of 2023, respectively.
General and administrative (G&A) expenses totaled $16.8 million and $50.4 million for the third quarter and first nine months of 2024, respectively, as compared to $16.6 million and $44.9 million for the third quarter and first nine months of 2023, respectively. The increase in G&A expenses for the first nine months of 2024 compared to the same period in the prior year was primarily related to higher personnel related expenses. G&A expenses included non-cash share-based compensation expense of $5.9 million and $19.2 million for the third quarter and first nine months of 2024, respectively, as compared to $6.0 million and $15.7 million for the third quarter and first nine months of 2023, respectively.
Total non-cash share-based compensation expense was $11.0 million and $35.4 million for the third quarter and first nine months of 2024, respectively, as compared to $10.9 million and $29.8 million for the third quarter and first nine months of 2023, respectively.

As of September 30, 2024, Prothena had $520.1 million in cash, cash equivalents and restricted cash, and no debt.
As of November 6, 2024, Prothena had approximately 53.8 million ordinary shares outstanding.

2024 Financial Guidance

The Company continues to expect full year 2024 net cash used in operating and investing actives to be $148 to $160 million and expects to end the year with approximately $468 million (midpoint) in cash, cash equivalents and restricted cash. The estimated full year 2024 net cash used from operating and investing activities is primarily driven by an estimated net loss of $120 to $135 million, which includes an estimated $48 million of non-cash share-based compensation expense.



About Prothena
Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid 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 pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis with cardiomyopathy, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company 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 and completion of our ongoing clinical trials; the continued advancement of our discovery, preclinical, and clinical pipeline, and expected milestones in 2024, 2025, and beyond; the treatment potential, designs, proposed mechanisms of action, and potential administration of PRX012, BMS-986446/PRX005, PRX123, prasinezumab, PRX019, birtamimab, and coramitug/PRX004; plans for ongoing and future clinical trials of PRX012, BMS-986446/PRX005, PRX123, prasinezumab, PRX019, birtamimab, and coramitug/PRX004; the expected timing of reporting data from clinical trials, including multiple clinical readouts starting in mid-2025 and continuing throughout the year from our ongoing Phase 1 clinical trials evaluating PRX012 and topline study results for our Phase 3 AFFIRM-AL clinical trial between in 1H 2025; our anticipated net cash burn from operating and investing activities for 2024 and expected cash balance at the end of 2024; and our estimated net loss and non-cash share-based compensation expense for 2024. 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 those described in the “Risk Factors” sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 12, 2024, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake 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 our expectations.





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

Three Months Ended 
September 30,
Nine Months Ended 
September 30,
2024202320242023
Collaboration revenue$970 $84,866 $132,984 $91,004 
Revenue from license and intellectual property— — 50 50 
Total revenue970 84,866 133,034 91,054 
Operating expenses:
Research and development50,723 57,913 172,347 158,680 
General and administrative16,760 16,645 50,351 44,895 
Total operating expenses67,483 74,558 222,698 203,575 
Income (loss) from operations
(66,513)10,308 (89,664)(112,521)
Total other income, net
6,677 8,507 20,235 22,659 
Income (loss) before income taxes
(59,836)18,815 (69,429)(89,862)
Benefit from income taxes
(835)(3,092)(5,075)(10,310)
Net income (loss)
$(59,001)$21,907 $(64,354)$(79,552)
Basic net income (loss) per ordinary share$(1.10)$0.41 $(1.20)$(1.50)
Diluted net income (loss) per ordinary share$(1.10)$0.38 $(1.20)$(1.50)
Shares used to compute basic net income (loss) per share53,790 53,559 53,757 53,064 
Shares used to compute diluted net income (loss) per share53,790 58,004 53,757 53,064 


PROTHENA CORPORATION PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
September 30,December 31,
20242023
Assets
Cash and cash equivalents$519,262 $618,830 
Restricted cash, current
— 1,352 
Prepaid expenses and other current assets15,722 19,100 
Total current assets534,984 
 
639,282 
Property and equipment, net3,254 3,836 
Operating lease right-of-use assets11,400 12,162 
Restricted cash, non-current860 860 
Other non-current assets44,756 40,242 
Total non-current assets60,270 57,100 
Total assets$595,254 $696,382 
Liabilities and Shareholders’ Equity
Accrued research and development10,340 14,724 
Deferred revenue, current
8,832 — 
Lease liability, current2,613 1,114 
Other current liabilities24,637 41,053 
Total current liabilities46,422 56,891 
Deferred revenue, non-current
5,589 67,405 
Lease liability, non-current8,881 10,721 
     Total non-current liabilities14,470 78,126 
Total liabilities60,892 135,017 
Total shareholders’ equity534,362 561,365 
Total liabilities and shareholders’ equity$595,254 $696,382 

Contacts:

Investors
Mark Johnson, CFA, Vice President, Investor Relations
650-417-1974, mark.johnson@prothena.com

Media
Michael Bachner, Senior Director, Corporate Communications
609-664-7308, michael.bachner@prothena.com

v3.24.3
Cover Page
Nov. 12, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Nov. 12, 2024
Entity Registrant Name PROTHENA CORPORATION PUBLIC LIMITED COMPANY
Entity Incorporation, State or Country Code L2
Entity File Number 001-35676
Entity Tax Identification Number 98-1111119
Entity Address, Address Line One 77 Sir John Rogerson's Quay, Block C
Entity Address, Address Line Two Grand Canal Docklands
Entity Address, City or Town Dublin 2,
Entity Address, Postal Zip Code D02 VK60,
Entity Address, Country IE
Country Region 353
City Area Code 1
Local Phone Number 236-2500
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Ordinary Shares, par value $0.01 per share
Trading Symbol PRTA
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001559053
Amendment Flag false
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