Prothena Reports Second Quarter 2020 Financial Results and Provides R&D Update
- Net cash used in operating and investing activities was
$18.7 millionin the second quarter and $41.9 millionfor the first six months of 2020; quarter-end cash and restricted cash position of $336.6 millionprovides funding to advance a broad pipeline
“We continue to expect multiple clinical data read-outs later this year across our pipeline,” said
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 Roche
- Part 1 of the Phase 2 PASADENA study in patients with early Parkinson’s disease (N=316), being conducted by Roche, is complete. Results from Part 1 of the study have been selected as an oral Top Abstract presentation at the upcoming virtual
International Congressof Parkinson’s Disease and Movement Disorders Society(MDS) on September 14, 2020.
- The 52-week blinded extension of the study (Part 2 of the Phase 2 PASADENA Study) is ongoing. COVID-19 has caused some participants to miss assessments in Part 2 of the study. Mitigation efforts have been put in place to ensure patient safety, and the situation is improving in most geographies. Roche continues to monitor the situation carefully to minimize patient risk and the impact on the study.
PRX004, a potential treatment for ATTR amyloidosis, is a monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein
- Since interim data from cohorts 1 through 5 were reported in December, patients in all 6 cohorts of the Phase 1 study of PRX004 have received the three infusions and assessments that comprised the dose-escalation portion of the study.
- The long-term extension (LTE) portion of the study, which allowed for up to 15 additional infusions, experienced disruptions due to the COVID-19 pandemic. However, 6 patients in cohorts 4 and 5, and 1 patient in cohort 6 completed one post-baseline neuropathy assessment following 9 months of PRX004 administration.
- The Company expects to report new data in the fourth quarter of this year from the dose-escalation and available LTE portion of the study. This timing, however, is dependent on ongoing COVID-19 restrictions at clinical study sites that can impact data collection and analyses.
- The Company continues to believe that the study has advanced sufficiently to determine next steps for the program, and has begun further clinical development planning activities, expecting to disclose next steps in the fourth quarter of this year.
Discovery and Preclinical Development:
- The Company continues to expect to advance IND-enabling activities in 2020 for our preclinical tau program, part of a global neuroscience collaboration with Bristol-Myers Squibb.
- The Company continues to expect to initiate IND-enabling activities in 2020 for our preclinical Aβ program.
Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:
BTIG Virtual Biotechnology Conference2020 on August 11, 2020at 1:00PM Eastern Time
A live webcast of the presentations can be accessed through the Investors 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.
Second Quarter and First Six Months of 2020 Financial Results
For the second quarter and first six months of 2020,
Research and development (R&D) expenses totaled
General and administrative (G&A) expenses totaled
Total non-cash share-based compensation expense was
The Company continues to expect its full year 2020 net cash burn from operating and investing activities to be
Inducement Grant Under NASDAQ Listing Rule 5635(
In connection with hiring an employee, the compensation committee of the Company’s board of directors granted the individual hired by the Company an option to purchase 60,000 ordinary shares of the Company. The stock option has an exercise price per share equal to
This press release contains forward-looking statements. These statements relate to, among other things, the sufficiency of our cash position to fund advancement of a broad pipeline; the treatment potential and proposed mechanisms of action of prasinezumab and PRX004; plans for the ongoing Phase 2 clinical study of prasinezumab and the Phase 1 clinical study of PRX004; the expected timing of reporting data from the Phase 1 clinical study of PRX004 and from the Phase 2 clinical study of prasinezumab; plans for future clinical studies of prasinezumab and PRX004; the continued advancement of our discovery and preclinical pipeline; the timing of IND-enabling activities from our tau and Aβ programs; our anticipated net cash burn from operating and investing activities for 2020 and expected cash balance at the end of 2020; and our estimated net loss and non-cash share-based compensation expense for 2020. 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 effects on our business of the worldwide COVID-19 pandemic and 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
||Six Months Ended
|Research and development||17,271||9,583||32,519||22,879|
|General and administrative||9,656||9,081||19,397||18,986|
|Total operating expenses||26,927||18,664||51,916||41,804|
|Loss from operations||(26,732||)||(18,497||)||(51,580||)||(41,451||)|
|Other income, net||195||2,531||1,308||4,818|
|Loss before income taxes||(26,537||)||(15,966||)||(50,272||)||(36,633||)|
|Provision for (benefit from) income taxes||(255||)||(156||)||(421||)||42|
|Basic and diluted net loss per share||$||(0.66||)||$||(0.40||)||$||(1.25||)||$||(0.92||)|
|Shares used to compute basic and diluted net loss per share||39,911||39,872||39,910||39,868|
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
|Cash and cash equivalents||$||333,942||$||375,723|
|Prepaid expenses and other current assets||7,125||2,584|
|Total current assets||341,123||378,375|
|Property and equipment, net||3,215||3,874|
|Operating lease right-of-use assets||20,570||23,274|
|Restricted cash, non-current||2,704||2,704|
|Other non-current assets||11,321||11,041|
|Total non-current assets||37,810||40,893|
|Liabilities and Shareholders’ Equity|
|Accrued research and development||$||6,152||$||5,826|
|Lease liability, current||5,304||5,101|
|Other current liabilities||7,088||6,787|
|Total current liabilities||18,544||17,714|
|Lease liability, non-current||15,150||17,838|
|Other non-current liabilities||553||553|
|Total non-current liabilities||125,945||128,633|
|Total shareholders’ equity||234,444||272,921|
|Total liabilities and shareholders’ equity||$||378,933||$||419,268|
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Source: Prothena Corporation plc