DUBLIN, Ireland, May 09, 2017 (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 of 2017. In addition, the Company provided an update on its R&D programs.
"Enrollment is now complete in our Phase 2b PRONTO study evaluating NEOD001 for the potential treatment of AL amyloidosis and we expect topline results from this study in the second quarter of 2018," said Gene Kinney, PhD, President and Chief Executive Officer of Prothena. "Later this month, we also expect to meet an important milestone by completing over-enrollment of our Phase 3 VITAL Amyloidosis Study evaluating NEOD001 in newly diagnosed, treatment naïve patients with AL amyloidosis and cardiac dysfunction. Our balance sheet enables us to progress our clinical programs through key milestones and we are steadily advancing a diverse pipeline of protein immunotherapies across multiple therapeutic categories while strengthening our organization to plan for commercialization of our lead program, NEOD001."
First Quarter 2017 and Recent Highlights:
Upcoming Research and Development Milestones
Prothena's pipeline includes four protein immunotherapy programs.
NEOD001 is a monoclonal antibody for the potential treatment of AL amyloidosis:
PRX002/RG7935 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:
PRX003 is a monoclonal antibody for the potential treatment of inflammatory diseases, including psoriasis and psoriatic arthritis:
PRX004 is a monoclonal antibody for the potential treatment of ATTR amyloidosis:
First Quarter 2017 Financial Results and Updated 2017 Financial Guidance
Prothena reported a net loss of $35.4 million for the first quarter of 2017, as compared to a net loss of $27.5 million for the first quarter of 2016. Net loss per share for the first quarter of 2017 was $0.99, as compared to a net loss per share for the first quarter of 2016 of $0.81.
Prothena reported total revenue of $0.3 million for the first quarter of 2017, as compared to total revenue of $0.3 million for the first quarter of 2016.
Research and development (R&D) expenses totaled $25.7 million for the first quarter of 2017, as compared to $20.5 million for the first quarter of 2016. The increase in R&D expenses for the first quarter of 2017 was primarily due to increased personnel cost, and higher expenses for product manufacturing and clinical trials. R&D expenses included non-cash share-based compensation expense of $2.3 million for the first quarter of 2017, as compared to $1.4 million for the first quarter of 2016.
General and administrative (G&A) expenses totaled $10.8 million for the first quarter of 2017, as compared to $7.2 million for first quarter of 2016. The increase in G&A expenses for the first quarter of 2017 was primarily due to increases in personnel costs, consulting expense and other expenses, partially offset by a gain recognized from the assignment of our former South San Francisco facility lease. G&A expenses included non-cash share-based compensation expense of $3.3 million in the first quarter of 2017, as compared to $2.3 million in the first quarter of 2016.
Total non-cash share-based compensation expense was $5.6 million for the first quarter of 2017, as compared to $3.7 million for the first quarter of 2016.
As of March 31, 2017, Prothena had $510.6 million in cash, cash equivalents and restricted cash, and no debt.
As of April 21, 2017, Prothena had approximately 38.0 million ordinary shares outstanding.
The Company expects the full year 2017 net cash burn from operating and investing activities to be $160 to $170 million, including an expected milestone payment from Roche upon initiation of the Phase 2 study of PRX002/RG7935, and to end the year with approximately $375 million in cash, cash equivalents and restricted cash (mid-point), which has been updated to include the recent $150.3 million from the March 2017 public equity offering. The estimated full year 2017 net cash burn from operating and investing activities is primarily driven by an estimated net loss of $177 to $191 million, which includes an estimated $26 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:
A live webcast of the presentations can be accessed through the investor relations section of the Company's website at www.prothena.com. Following the live presentations, a replay of the webcast will be available on the Company's website for at least 90 days following the presentation date.
Prothena Corporation plc is a global, late-stage clinical biotechnology company establishing fully-integrated research, development and commercial capabilities. 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 seeks to fundamentally change the course of progressive diseases associated with this biology. The Company's pipeline of antibody therapeutic candidates targets a number of indications including AL amyloidosis (NEOD001), Parkinson's disease and other related synucleinopathies (PRX002/RG7935), inflammatory diseases, including psoriasis and psoriatic arthritis (PRX003), and ATTR amyloidosis (PRX004). The Company continues discovery of additional novel therapeutic candidates where its deep scientific understanding of disease pathology can be leveraged. For more information, please visit the Company's website at www.prothena.com
This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash position to advance our R&D pipeline through key milestones; the timing of completing enrollment in the Phase 3 study and announcing topline results from the Phase 2b study of NEOD001; the timing of initiating a Phase 2 study of PRX002/RG7935; the timing of announcing topline results from the Phase 1b study of PRX003; the timing of initiating clinical development of PRX004; our anticipated net cash burn from operating and investing activities for 2017 and expected cash balance at the end of 2017; and our estimated net loss and non-cash share-based compensation expense for 2017. 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 27, 2017 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|
|Research and development||25,698||20,493|
|General and administrative||10,832||7,182|
|Total operating expenses||36,530||27,675|
|Loss from operations||(36,271||)||(27,410||)|
|Other income (expense), net:||(774||)||70|
|Loss before income taxes||(37,045||)||(27,340||)|
|Provision for (benefit from) income taxes||(1,661||)||181|
|Basic and diluted net loss per share||$||(0.99||)||$||(0.81||)|
|Shares used to compute basic and diluted net loss per share||35,758||34,026|
PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
|March 31,||December 31,|
|Cash and cash equivalents||$||506,550||$||386,923|
|Other current assets||7,654||4,439|
|Total current assets||514,204||391,362|
|Property and equipment, net||56,084||56,452|
|Total non-current assets||67,746||68,614|
|Liabilities and Shareholders' Equity|
|Accrued research and development||$||21,710||$||19,073|
|Other current liabilities||11,970||22,002|
|Total current liabilities||33,680||41,075|
|Total shareholders' equity||496,248||365,403|
|Total liabilities and shareholders' equity||$||581,950||$||459,976|
Contacts Investors: Tran Nguyen, CFO 650-837-8535, IR@prothena.com Media: Ellen Rose, Head of Communications 650-922-2405, firstname.lastname@example.org