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Feb 14, 2019
Prothena Reports Fourth Quarter and Full Year 2018 Financial Results, and Provides Financial Guidance and R&D Update
Prothena Reports Fourth Quarter and Full Year 2018 Financial Results, and Provides Financial Guidance and R&D Update
- Net cash used in operating and investing activities was
$22.5 million in the fourth quarter and$30.0 million for the full year 2018; quarter-end cash and restricted cash position of$431.7 million provides funding to advance neuroscience pipeline
- Entered into global neuroscience research & development collaboration with
Celgene to advance novel therapies for patients with neurodegenerative diseases - Initiated a first-in-human study of PRX004 in patients with ATTR amyloidosis
- Enrollment completed for the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson’s disease
“In 2018, we continued to advance our neuroscience pipeline of novel investigational therapeutics towards key milestones,” said
Full Year 2018 and Recent Developments:
Prasinezumab (PRX002/RG7935), a potential treatment for Parkinson’s disease, is a monoclonal antibody designed to target alpha-synuclein and is the focus of the worldwide collaboration with
- Published results from the Phase 1b multiple ascending dose study of prasinezumab 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.”
- Enrollment completed (N=316) in the Phase 2 PASADENA study being conducted by
Roche in patients with early Parkinson’s disease.
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 (misTTR) without affecting the native, or normal tetrameric form of the protein
- Achieved first-in-human dosing in a Phase 1 clinical study of PRX004 in patients with hereditary ATTR (hATTR) amyloidosis. The Phase 1 study will inform possible future studies and will include the use of Prothena’s proprietary misTTR assay as a pharmacodynamic measure of the levels of non-native TTR species in plasma of patients across multiple hereditary TTR mutations.
- Presented a broad range of research in oral and poster presentations at the 16th International Symposium on Amyloidosis (ISA). New research was presented at ISA relating to PRX004 for the potential treatment of ATTR amyloidosis, including on our proprietary misTTR assay as well as preclinical research demonstrating that conformation-specific antibodies target misTTR and induce immune mediated clearance through phagocytosis.
Discovery:
- Entered into a global neuroscience research & development collaboration with
Celgene to develop new therapies for a broad range of neurodegenerative diseases. The collaboration is focused on three targets implicated in the pathogenesis of several neurodegenerative diseases, inducing tau, TDP-43 and a third that is undisclosed.Prothena received a$100 million upfront payment and a$50 million equity investment byCelgene and is eligible to receive future potential exercise payments and regulatory and commercial milestones for each licensed program.Prothena is also eligible to receive additional royalties on net sales of any resulting marketed product.
- Entered into a multi-target license and option agreement with
Bioasis Technologies Inc. Under the agreement,Prothena made an upfront payment of$1 million toBioasis and is exploring the application of Bioasis’s xB3 platform technology to increase the delivery of therapeutics across the blood-brain barrier (BBB) for neuroscience disorders.
Corporate
- Appointed
Radhika Tripuraneni , MD, MPH as Chief Development Officer. Dr. Tripuraneni is the Company’s lead medical clinician, managing the clinical development, clinical operations, medical affairs and biometrics functions. She joinedProthena in 2018 as Vice President, Medical Affairs & Development Operations. Dr. Tripuraneni trained as a surgeon and has extensive biotech and investment industry experience across multiple therapeutic categories. - Appointed
Tran B. Nguyen as Chief Operating Officer, in addition to his responsibilities as Chief Financial Officer. Mr. Nguyen has 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.
Prasinezumab
- The Phase 2 PASADENA study in patients with early Parkinson’s disease (N=316) is being conducted by
Roche and data from Part 1 of this study are expected in 2020
PRX004
- The Phase 1 study of PRX004 continues to enroll patients with hATTR amyloidosis, and preliminary data from lower dose cohorts, including safety, tolerability and pharmacodynamics, are expected in the fourth quarter of 2019
Discovery
- The preclinical tau program, part of 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 and to communicate preclinical data in the fourth quarter of 2019
Fourth Quarter and Full Year of 2018 Financial Results and 2019 Financial Guidance
Research and development (R&D) expenses totaled
General and administrative (G&A) expenses totaled
Restructuring credit totaled
Total non-cash share-based compensation expense was
As of December 31, 2018,
As of February 8, 2019,
The Company expects the full year 2019 net cash burn from operating and investing activities to be
Conference Call Details
To access the call via dial-in, please dial (877) 887-5215 (U.S. and
About
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 our neuroscience pipeline; the treatment potential and proposed mechanisms of action of prasinezumab and PRX004; the expected timing of reporting data from the Phase 1 clinical study of PRX004; the expected timing of reporting data from the Phase 2 clinical study of prasinezumab; the continued advancement of our discovery pipeline; the timing of initiating cell line development from our tau and abeta programs, and the timing of communicating preclinical data from the abeta program; the potential to receive future exercise payments, regulatory and commercial milestones and royalties under the
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)
| Three Months Ended December 31, |
Twelve Months Ended December 31, |
|||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Collaboration revenue | $ | 194 | $ | 229 | $ | 955 | $ | 27,519 | ||||||||
| Total revenue | 194 | 229 | 955 | 27,519 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 16,510 | 33,502 | 101,183 | 134,547 | ||||||||||||
| General and administrative | 8,026 | 14,044 | 42,482 | 48,226 | ||||||||||||
| Restructuring and related impairment charges | (1,587 | ) | — | 16,145 | — | |||||||||||
| Total operating expenses | 22,949 | 47,546 | 159,810 | 182,773 | ||||||||||||
| Loss from operations | (22,755 | ) | (47,317 | ) | (158,855 | ) | (155,254 | ) | ||||||||
| Other income (expense), net | 845 | (154 | ) | 2,740 | (2,349 | ) | ||||||||||
| Loss before income taxes | (21,910 | ) | (47,471 | ) | (156,115 | ) | (157,603 | ) | ||||||||
| Provision for (benefit from) income taxes | 551 | 287 | (470 | ) | (4,366 | ) | ||||||||||
| Net loss | $ | (22,461 | ) | $ | (47,758 | ) | $ | (155,645 | ) | $ | (153,237 | ) | ||||
| Basic and diluted net loss per share | $ | (0.56 | ) | $ | (1.24 | ) | $ | (3.93 | ) | $ | (4.07 | ) | ||||
| Shares used to compute basic and diluted net loss per share | 39,864 | 38,455 | 39,559 | 37,654 | ||||||||||||
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
| December 31, | December 31, | ||||||
| 2018 | 2017 | ||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 427,659 | $ | 417,620 | |||
| Accounts receivable | 2 | 240 | |||||
| Other current assets | 3,729 | 8,467 | |||||
| Total current assets | 431,390 | 426,327 | |||||
| Property and equipment, net | 52,835 | 54,990 | |||||
| Restricted cash | 4,056 | 4,056 | |||||
| Other assets | 10,515 | 10,956 | |||||
| Total non-current assets | 67,406 | 70,002 | |||||
| Total assets | $ | 498,796 | $ | 496,329 | |||
| Liabilities and Shareholders’ Equity | |||||||
| Accrued research and development | $ | 5,370 | $ | 13,509 | |||
| Restructuring liability | 461 | — | |||||
| Other current liabilities | 9,095 | 23,862 | |||||
| Total current liabilities | 14,926 | 37,371 | |||||
| Deferred revenue | 110,242 | — | |||||
| Other non-current liabilities | 50,630 | 51,769 | |||||
| Total non-current liabilities | 160,872 | 51,769 | |||||
| Total liabilities | 175,798 | 89,140 | |||||
| Total shareholders’ equity | 322,998 | 407,189 | |||||
| Total liabilities and shareholders’ equity | $ | 498,796 | $ | 496,329 | |||
Media and Investor Contact:
650-922-2405, ellen.rose@prothena.com
Source: Prothena Corporation plc