Prothena Reports Third Quarter 2019 Financial Results and Provides R&D Update
- Net cash used in operating and investing activities was
$9.2 million in the third quarter and$38.9 million for the first nine months of 2019; quarter-end cash and restricted cash position of$393.0 million provides funding to advance a diversified neuroscience pipeline
“We continue to advance our proprietary programs as well as our collaboration programs with
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
- The Phase 2 PASADENA study in patients with early Parkinson’s disease was fully enrolled in
December 2018 (N=316) and is being conducted byRoche . 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 deplete the pathogenic, non-native forms of the TTR protein.
- The Phase 1 study of PRX004 continues to enroll patients with hATTR amyloidosis. 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 (
- The preclinical tau program, part of a worldwide collaboration with
Celgene , initiated cell line development of a lead candidate in the second quarter of 2019.
Third Quarter and First Nine Months of 2019 Financial Results
For the third quarter and first nine months of 2019,
Research and development (R&D) expenses totaled
General and administrative (G&A) expenses totaled
Total non-cash share-based compensation expense was
As of September 30, 2019,
As of October 25, 2019,
The Company continues to expect its full year 2019 net cash burn from operating and investing activities to be
About
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
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Collaboration revenue | $ | 205 | $ | 255 | $ | 558 | $ | 761 | ||||||||
Total revenue | 205 | 255 | 558 | 761 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 12,486 | 18,515 | 35,365 | 84,673 | ||||||||||||
General and administrative | 8,691 | 9,235 | 27,677 | 34,456 | ||||||||||||
Restructuring charges (credits) | — | (3,172 | ) | (61 | ) | 17,732 | ||||||||||
Total operating expenses | 21,177 | 24,578 | 62,981 | 136,861 | ||||||||||||
Loss from operations | (20,972 | ) | (24,323 | ) | (62,423 | ) | (136,100 | ) | ||||||||
Other income, net | 1,992 | 726 | 6,810 | 1,895 | ||||||||||||
Loss before income taxes | (18,980 | ) | (23,597 | ) | (55,613 | ) | (134,205 | ) | ||||||||
Provision for (benefit from) income taxes | 468 | 962 | 510 | (1,021 | ) | |||||||||||
Net loss | $ | (19,448 | ) | $ | (24,559 | ) | $ | (56,123 | ) | $ | (133,184 | ) | ||||
Basic and diluted net loss per share | $ | (0.49 | ) | $ | (0.62 | ) | $ | (1.41 | ) | $ | (3.38 | ) | ||||
Shares used to compute basic and diluted net loss per share | 39,897 | 39,850 | 39,877 | 39,457 |
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
September 30, | December 31, | ||||||
2019 | 2018 | ||||||
Assets | |||||||
Cash and cash equivalents | $ | 390,304 | $ | 427,659 | |||
Prepaid expenses and other current assets | 18,898 | 3,731 | |||||
Total current assets | 409,202 | 431,390 | |||||
Property and equipment, net | 4,245 | 52,835 | |||||
Operating lease right-of-use assets | 24,607 | — | |||||
Restricted cash, non-current | 2,704 | 4,056 | |||||
Other non-current assets | 10,136 | 10,515 | |||||
Total non-current assets | 41,692 | 67,406 | |||||
Total assets | $ | 450,894 | $ | 498,796 | |||
Liabilities and Shareholders’ Equity | |||||||
Accrued research and development | $ | 4,253 | $ | 5,370 | |||
Restructuring liability | — | 461 | |||||
Lease liability, current | 5,002 | — | |||||
Other current liabilities | 22,508 | 9,095 | |||||
Total current liabilities | 31,763 | 14,926 | |||||
Deferred revenue | 110,242 | 110,242 | |||||
Lease liability, non-current | 19,161 | — | |||||
Other non-current liabilities | 553 | 50,630 | |||||
Total non-current liabilities | 129,956 | 160,872 | |||||
Total liabilities | 161,719 | 175,798 | |||||
Total shareholders’ equity | 289,175 | 322,998 | |||||
Total liabilities and shareholders’ equity | $ | 450,894 | $ | 498,796 |
Media and Investor Contact:
650-922-2405, ellen.rose@prothena.com
Source: Prothena Corporation plc