Prothena Reports Second Quarter 2018 Financial Results and Provides R&D Update
- Net loss was
$59.9 million in the second quarter and$108.6 million for the first six months endedJune 30, 2018
- Net cash from operating and investing activities was
$58.0 million in the second quarter and$26.3 million in the first six months of 2018; quarter-end cash and restricted cash position of$490.3 million , provides funding to advance a broad neuroscience pipeline
- Published results from the Phase 1b multiple ascending dose study of prasinezumab (PRX002/RG7935) in patients with Parkinson’s disease in JAMA Neurology
“We are developing a broad and novel pipeline targeting devastating neurological diseases and steadily advancing both our proprietary programs as well as our collaboration programs with
Second Quarter 2018 and Recent Highlights:
- Published results from the Phase 1b multiple ascending dose study of prasinezumab (PRX002/RG7935) in patients with Parkinson’s disease in JAMA Neurology. The paper is entitled “Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti–α-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial.”
- Appointed
Tran B. Nguyen as Chief Operating Officer, in addition to his responsibilities as Chief Financial Officer. Mr. Nguyen had been Prothena’s Chief Financial Officer since 2013 and has more than 20 years of experience including strategic leadership positions in the biotech, banking and private equity industries.
- Initiated a reorganization and updated financial guidance to align the Company’s resources on advancing its broad neuroscience pipeline.
Prasinezumab (PRX002/RG7935)
- The Phase 2 PASADENA study, which is being conducted by
Roche and was initiated in the second quarter of 2017, continues to enroll patients with early Parkinson’s disease, and data from this study are expected in 2020
PRX004
- The Phase 1 study of PRX004, initiated in the second quarter of 2018, continues to enroll patients with ATTR amyloidosis, and pharmacodynamic data from the lower doses of this study are expected in 2019
Discovery
- The preclinical tau program (a worldwide collaboration with
Celgene ) is expected to initiate cell line development of a lead candidate in 2019 - The preclinical Aβ (Amyloid beta) program is expected to initiate cell line development of a lead candidate in 2019
Second Quarter and First Six Months of 2018 Financial Results
For the second quarter and first six months of 2018,
Research and development (R&D) expenses totaled
General and administrative (G&A) expenses totaled
Total non-cash share-based compensation expense was
As of June 30, 2018,
As of July 20, 2018,
The Company expects its 2018 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 a broad neuroscience pipeline; or goal of developing a broad and novel pipeline targeting neurological diseases; the potential of our multiple discovery-stage programs to eventually offer significant benefit to patients; the expected timing of having data from our Phase 2 study of prasinezumab (PRX002/RG7935) and our Phase 1 study of PRX004; the expected timing of initiating cell line development of lead candidates from our preclinical tau and Aβ programs; our expected net cash burn from operating and investing activities for 2018 and cash balance at the end of 2018; and our estimated net loss and non-cash share-based compensation expense for 2018. 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 June 30, |
Six Months Ended June 30, |
|||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Collaboration revenue | $ | 279 | $ | 26,812 | $ | 506 | $ | 27,071 | ||||||||
Total revenue | 279 | 26,812 | 506 | 27,071 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 31,452 | 34,032 | 66,158 | 59,730 | ||||||||||||
General and administrative | 10,992 | 10,912 | 25,221 | 21,744 | ||||||||||||
Restructuring costs | 20,904 | — | 20,904 | — | ||||||||||||
Total operating expenses | 63,348 | 44,944 | 112,283 | 81,474 | ||||||||||||
Loss from operations | (63,069 | ) | (18,132 | ) | (111,777 | ) | (54,403 | ) | ||||||||
Other income (expense), net | 1,241 | (856 | ) | 1,169 | (1,630 | ) | ||||||||||
Loss before income taxes | (61,828 | ) | (18,988 | ) | (110,608 | ) | (56,033 | ) | ||||||||
Benefit from income taxes | (1,946 | ) | (1,287 | ) | (1,983 | ) | (2,948 | ) | ||||||||
Net loss | $ | (59,882 | ) | $ | (17,701 | ) | $ | (108,625 | ) | $ | (53,085 | ) | ||||
Basic and diluted net loss per share | $ | (1.50 | ) | $ | (0.46 | ) | $ | (2.77 | ) | $ | (1.44 | ) | ||||
Shares used to compute basic and diluted net loss per share | 39,824 | 38,073 | 39,257 | 36,922 | ||||||||||||
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
June 30, | December 31, | ||||||
2018 | 2017 | ||||||
Assets | |||||||
Cash and cash equivalents | $ | 486,212 | $ | 417,620 | |||
Accounts receivable | 8 | 240 | |||||
Other current assets | 7,817 | 8,467 | |||||
Total current assets | 494,037 | 426,327 | |||||
Property and equipment, net | 53,398 | 54,990 | |||||
Restricted cash | 4,056 | 4,056 | |||||
Other assets | 11,809 | 10,956 | |||||
Total non-current assets | 69,263 | 70,002 | |||||
Total assets | $ | 563,300 | $ | 496,329 | |||
Liabilities and Shareholders’ Equity | |||||||
Accrued research and development | $ | 10,160 | $ | 13,509 | |||
Restructuring liability | 18,396 | — | |||||
Other current liabilities | 17,576 | 23,862 | |||||
Total current liabilities | 46,132 | 37,371 | |||||
Deferred revenue | 110,242 | — | |||||
Other non-current liabilities | 50,920 | 51,769 | |||||
Total non-current liabilities | 161,162 | 51,769 | |||||
Total liabilities | 207,294 | 89,140 | |||||
Total shareholders’ equity | 356,006 | 407,189 | |||||
Total liabilities and shareholders’ equity | $ | 563,300 | $ | 496,329 | |||
Media and Investor Contact:
650-922-2405, ellen.rose@prothena.com
Source: Prothena Corporation plc