Prothena Reports Second Quarter 2019 Financial Results and Provides R&D Update
- Net cash used in operating and investing activities was
$12.2 million in the second quarter and$29.7 million for the first six months of 2019; quarter-end cash and restricted cash position of$402.2 million provides funding to advance neuroscience pipeline - Appointed
Paula K. Cobb to Prothena’s Board of Directors andMichael J. Malecek as Prothena’sChief Legal Officer and Company Secretary
“We remain on track to report interim clinical data from the Phase 1 study of PRX004 for ATTR amyloidosis in the fourth quarter of this year, and results from Part 1 of the PASADENA Phase 2 study of prasinezumab for Parkinson’s disease are expected in 2020,” said
Mr. Malecek’s appointment was made in conjunction with the retirement of
“I am excited to join
Second Quarter 2019 and Recent Developments
- Appointed
Paula K. Cobb to Prothena’s Board of Directors. Ms. Cobb is the Chief Operating Officer ofDecibel Therapeutics, Inc. , and has extensive global development, business strategy and commercial experience. Prior to joining Decibel in 2016, Ms. Cobb worked in a variety of global leadership roles at Biogen, including as Senior Vice President of the rare disease group, where she was responsible for the company’s marketed hemophilia assets and Phase 3 programs in spinal muscular atrophy and neuropathic pain. She served on the board of directors ofNightstar Therapeutics plc , a clinical-stage gene therapy company, until its acquisition by Biogen. - Appointed
Michael J. Malecek asChief Legal Officer and Company Secretary. Prior to joining Prothena, Mr. Malecek was Vice President and Deputy General Counsel of Intellectual Property & Litigation at Snowflake Computing. Previously, he was a Partner at the law firms ofArnold & Porter Kaye Scholer , Kaye Scholer andDewey & LeBoeuf . In these positions he served as Managing Partner of theSilicon Valley offices and represented a range of life science companies, including Affymetrix and Complete Genomics, on intellectual property, compliance and securities law matters. Mr. Malecek’s experience in the life science industry also includes six years as Vice President and Chief Advocacy Counsel at Affymetrix.
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 target and clear the pathogenic, non-native forms of the TTR protein.
- The Phase 1 study of PRX004 continues to enroll patients with hATTR amyloidosis, and 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 this year
Second Quarter and First Six Months of 2019 Financial Results
For the second quarter and first six 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 June 30, 2019,
As of July 19, 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 June 30, |
Six Months Ended June 30, |
|||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Collaboration revenue | $ | 167 | $ | 279 | $ | 353 | $ | 506 | ||||||||
Total revenue | 167 | 279 | 353 | 506 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 9,583 | 31,452 | 22,879 | 66,158 | ||||||||||||
General and administrative | 9,081 | 10,992 | 18,986 | 25,221 | ||||||||||||
Restructuring charges (credits) | — | 20,904 | (61 | ) | 20,904 | |||||||||||
Total operating expenses | 18,664 | 63,348 | 41,804 | 112,283 | ||||||||||||
Loss from operations | (18,497 | ) | (63,069 | ) | (41,451 | ) | (111,777 | ) | ||||||||
Other income, net | 2,531 | 1,241 | 4,818 | 1,169 | ||||||||||||
Loss before income taxes | (15,966 | ) | (61,828 | ) | (36,633 | ) | (110,608 | ) | ||||||||
Provision for (benefit from) income taxes | (156 | ) | (1,946 | ) | 42 | (1,983 | ) | |||||||||
Net loss | $ | (15,810 | ) | $ | (59,882 | ) | $ | (36,675 | ) | $ | (108,625 | ) | ||||
Basic and diluted net loss per share | $ | (0.40 | ) | $ | (1.50 | ) | $ | (0.92 | ) | $ | (2.77 | ) | ||||
Shares used to compute basic and diluted net loss per share | 39,872 | 39,824 | 39,868 | 39,257 |
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
June 30, | December 31, | ||||||
2019 | 2018 | ||||||
Assets | |||||||
Cash and cash equivalents | $ | 398,144 | $ | 427,659 | |||
Restricted cash, current | 1,352 | — | |||||
Prepaid expenses and other current assets | 19,212 | 3,731 | |||||
Total current assets | 418,708 | 431,390 | |||||
Property and equipment, net | 4,318 | 52,835 | |||||
Operating lease right-of-use assets | 25,927 | — | |||||
Restricted cash, non-current | 2,704 | 4,056 | |||||
Other non-current assets | 10,415 | 10,515 | |||||
Total non-current assets | 43,364 | 67,406 | |||||
Total assets | $ | 462,072 | $ | 498,796 | |||
Liabilities and Shareholders’ Equity | |||||||
Accrued research and development | $ | 2,260 | $ | 5,370 | |||
Restructuring liability | — | 461 | |||||
Lease liability, current | 4,904 | — | |||||
Other current liabilities | 20,852 | 9,095 | |||||
Total current liabilities | 28,016 | 14,926 | |||||
Deferred revenue | 110,242 | 110,242 | |||||
Lease liability, non-current | 20,454 | — | |||||
Other non-current liabilities | 553 | 50,630 | |||||
Total non-current liabilities | 131,249 | 160,872 | |||||
Total liabilities | 159,265 | 175,798 | |||||
Total shareholders’ equity | 302,807 | 322,998 | |||||
Total liabilities and shareholders’ equity | $ | 462,072 | $ | 498,796 |
Media and Investor Contact:
650-922-2405, ellen.rose@prothena.com
Source: Prothena Corporation plc