Prothena Reports Third Quarter 2020 Financial Results and Provides R&D Update
- Net cash used in operating and investing activities was
$19.5 millionin the third quarter and $61.4 millionfor the first nine months of 2020; quarter-end cash and restricted cash position of $317.2 millionprovides funding to advance the R&D pipeline
- Roche presented results from the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson’s disease in an oral top abstract presentation at
- Announced that Roche and
Prothenawill advance prasinezumab into late-stage clinical development
- Presented new preclinical data from two Alzheimer’s disease programs at CTAD 2020
“During the third quarter, Roche presented data from the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson’s disease that demonstrated signals of efficacy consistent with disease modification and recently, we announced that prasinezumab will advance into a late-stage study,” said
Third Quarter and Recent Highlights
- Announced results from the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson’s disease that were presented by Roche at the International Parkinson and Movement Disorder Society’s
MDS Virtual Congress2020 ( MDS Congress2020) on September 15, 2020. Prasinezumab is the first potentially disease-modifying, anti-alpha-synuclein antibody to demonstrate signs of efficacy on multiple pre-specified secondary and exploratory clinical endpoints in patients with early Parkinson’s disease. In the study, prasinezumab significantly reduced decline in motor function by 35% (pooled dose levels) vs. placebo after one year of treatment on the centrally rated assessment of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, a clinical examination of motor function. Prasinezumab-treated patients also demonstrated a significant delay in time to clinically meaningful worsening of motor progression on the site rated assessment of time to at least a 5-point progression on MDS-UPDRS Part III vs. placebo over one year, with a hazard ratio of 0.82 (pooled dose levels).
- Announced that Roche and
Prothenawill advance prasinezumab into a late-stage (Phase 2b) study in patients with early Parkinson’s disease. The study will be designed to further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA to include patients with early Parkinson’s disease on stable levodopa therapy.
- Presented preclinical data from two programs in its Alzheimer’s disease portfolio at the 13th Clinical Trials on Alzheimer’s
Disease Conference2020 (CTAD 2020). First, a next generation anti- Aβ antibody, PRX012, for more convenient subcutaneous administration to improve patient access. Second, a multi-immunogen vaccine that targets both Aβ and Tau, two main pathological hallmarks of Alzheimer’s disease, for the prevention and treatment of Alzheimer’s disease.
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 2 of the Phase 2 PASADENA study (a 52-week blinded extension phase) is ongoing.
Prothenawill earn a $60 millionclinical milestone payment upon the first patient dosed in the Phase 2b study. Further details are expected to be announced in the first half of 2021.
PRX004, a potential treatment for ATTR amyloidosis, is a monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein
Prothenaexpects to report new data in fourth quarter of this year from the dose-escalation and available LTE portion of the study. Prothenacontinues to believe that the study has advanced sufficiently to determine next steps for the program and has begun further clinical development planning for next clinical studies in patients with moderate-to-advanced ATTR cardiomyopathy (ATTR-CM). Current therapies have not demonstrated efficacy in these patients who are at high risk of early mortality.
Discovery and Preclinical Development:
Prothenacontinues to expect to advance IND-enabling activities in 2020 for PRX005, our preclinical tau program, part of a global neuroscience collaboration with Bristol-Myers Squibb, and expects to file an IND in 2021. Prothenahas initiated IND-enabling studies for PRX012, our preclinical Aβ program, and expects to file an IND in 2021.
Upcoming Investor Conferences
Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:
- Stifel 2020
Virtual Healthcare Conferenceon Tuesday November 17, 2020at 4:00 PM Eastern Time Jefferies Virtual London Healthcare Conferenceon Thursday November 19, 2020at 2:55 PM 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.
Third Quarter and First Nine Months of 2020 Financial Results
For the third quarter and first nine 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 two new employees, the compensation committee of the Company’s board of directors granted the individuals hired by the Company, in the aggregate, options to purchase 90,000 ordinary shares of the Company. The options have 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, PRX004, PRX005 and PRX012; 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; plans for future clinical studies of prasinezumab and PRX004; amounts we might receive under our collaboration with Roche; 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 Securities and Exchange Commission (SEC) on March 3, 2020, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. Prothena undertakes no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in Prothena’s expectations.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)
|Three months ended
||Nine Months Ended
|Research and development||21,605||12,486||54,124||35,365|
|General and administrative||9,398||8,691||28,795||27,677|
|Total operating expenses||31,003||21,177||82,919||62,981|
|Loss from operations||(30,846||)||(20,972||)||(82,426||)||(62,423||)|
|Other income, net||54||1,992||1,362||6,810|
|Loss before income taxes||(30,792||)||(18,980||)||(81,064||)||(55,613||)|
|Provision for (benefit from) income taxes||(215||)||468||(636||)||510|
|Basic and diluted net loss per share||$||(0.77||)||$||(0.49||)||$||(2.02||)||$||(1.41||)|
|Shares used to compute basic and diluted net loss per share||39,917||39,897||39,912||39,877|
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)
|Cash and cash equivalents||$||314,525||$||375,723|
|Prepaid expenses and other current assets||4,586||2,584|
|Restricted cash, current||1,352||—|
|Total current assets||320,485||378,375|
|Property and equipment, net||2,899||3,874|
|Operating lease right-of-use assets||19,197||23,274|
|Restricted cash, non-current||1,352||2,704|
|Other non-current assets||11,851||11,041|
|Total non-current assets||35,299||40,893|
|Liabilities and Shareholders’ Equity|
|Accrued research and development||$||7,617||$||5,826|
|Lease liability, current||5,408||5,101|
|Other current liabilities||8,697||6,787|
|Total current liabilities||21,722||17,714|
|Deferred revenue, non current||110,242||110,242|
|Lease liability, non-current||13,753||17,838|
|Other non-current liabilities||553||553|
|Total non-current liabilities||124,548||128,633|
|Total shareholders’ equity||209,514||272,921|
|Total liabilities and shareholders’ equity||$||355,784||$||419,268|
Source: Prothena Corporation plc