PRTA Prothena Corporation plc
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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PRX002 (PASADENA)
Parkinson's disease
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Phase 2
Phase 2
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PRX004
ATTR amyloidosis
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Phase 1
Phase 1
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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NEOD001 VITAL
AL Amyloidosis
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Phase 3
Phase 3
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Phase 3 trial discontinued due to futility - April 23, 2018.
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NEOD001 PRONTO
Previously-treated patients with AL amyloidosis and persistent cardiac dysfunction
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Phase 2b
Phase 2b
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Phase 2b trial did not meet primary endpoint - April 23, 2018.
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PRX003
Psoriatic Arthritis
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Phase 1b
Phase 1b
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Phase 1b data released September 28, 2017 - insufficient meaningful clinical effect for further development.
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Latest News
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- Net cash used in operating and investing activities was $18.7 million in the second quarter and $41.9 million for the first six months of 2020; quarter-end cash and restricted cash position of $336.6 million provides funding to advance a broad pipeline
DUBLIN, Ireland, Aug. 06, 2020 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage company with expertise in protein dysregulation and a diverse pipeline of investigational therapeutics for neurodegenerative and rare peripheral amyloid diseases, today reported financial results for the second quarter and first six months of 2020. In addition, the Company provided an update on its R&D programs.
"We continue to expect multiple clinical data read-outs later this year across our pipeline," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "New data from Part 1 of the Phase 2 prasinezumab study (PASADENA) in Parkinson's disease, being conducted by Roche will be presented in an oral presentation next month at the Movement Disorders Society congress, and additional data from our Phase 1 study of PRX004 in ATTR amyloidosis are expected in the fourth quarter. In addition, we are making excellent progress on our early-stage pipeline targeting a range of neurological indications and look forward to sharing preclinical data from programs in our Alzheimer's disease portfolio later this year."
Second Quarter Research and Development Updates and Upcoming Milestones
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 Congress of 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: Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications
- 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.
Upcoming Investor Conference
Members of the senior management team will present and participate in investor meetings at the following upcoming investor conferences:
- BTIG Virtual Biotechnology Conference 2020 on August 11, 2020 at 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, Prothena reported a net loss of $26.3 million and $49.9 million, respectively, as compared to a net loss of $15.8 million and $36.7 million for the second quarter and first six months of 2019, respectively. The second quarter and first six months of 2019 included a restructuring credit of nil and $0.1 million, respectively, which resulted from an adjustment in previously recorded employee termination benefits associated with the discontinuation of the NEOD001 program. Net loss per share for the second quarter and first six months of 2020 was $0.66 and $1.25, respectively, as compared to a net loss per share of $0.40 and $0.92 for the second quarter and first six months 2019, respectively.
Prothena reported total revenue, primarily from its collaboration with Roche, of $0.2 million and $0.3 million for the second quarter and first six months of 2020, respectively, as compared to total revenue of $0.2 million and $0.4 million for the second quarter and first six months of 2019, respectively.
Research and development (R&D) expenses totaled $17.3 million and $32.5 million for the second quarter and first six months of 2020, respectively, as compared to $9.6 million and $22.9 million for the second quarter and first six months of 2019, respectively. The increase in R&D expense for the second quarter and first six months of 2020 compared to the same periods in the prior year was primarily due to higher collaboration expense with Roche related to the prasinezumab program and higher manufacturing costs (primarily related to the tau, Aβ and PRX004 programs). R&D expenses included non-cash share-based compensation expense of $2.1 million and $4.1 million for the second quarter and first six months of 2020, respectively, as compared to $2.1 million and $4.2 million for the second quarter and first six months of 2019, respectively.
General and administrative (G&A) expenses totaled $9.7 million and $19.4 million for the second quarter and first six months of 2020, respectively, as compared to $9.1 million and $19.0 million for the second quarter and first six months of 2019, respectively. The increase in G&A expenses for the second quarter and first six months of 2020 compared to the same periods in the prior year primarily related to higher costs for our director and officer insurance premiums and higher legal and accounting fees offset in part by lower personnel costs (including share-based compensation expense). G&A expenses included non-cash share-based compensation expense of $3.6 million and $7.1 million for the second quarter and first six months of 2020, respectively, as compared to $4.2 million and $8.3 million for the second quarter and first six months of 2019, respectively.
Total non-cash share-based compensation expense was $5.7 million and $11.2 million for the second quarter and first six months of 2020, respectively, as compared to $6.3 million and $12.5 million for the second quarter and first six months of 2019, respectively.
As of June 30, 2020, Prothena had $336.6 million in cash, cash equivalents and restricted cash and no debt.
As of July 31, 2020, Prothena had approximately 39.9 million ordinary shares outstanding.
The Company continues to expect its full year 2020 net cash burn from operating and investing activities to be $75-$85 million, and expects to end the year with approximately $299 million in cash, cash equivalents and restricted cash (midpoint). The estimated full year 2020 net cash burn from operating and investing activities is primarily driven by estimated net loss of $101-$118 million, which includes an estimated $23 million of non-cash share-based compensation expense.
Inducement Grant Under NASDAQ Listing Rule 5635(C)(4)
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 $12.76, which was the closing trading price on August 3, 2020, the date of the grant. The inducement award will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the date of grant and 1/48th of the underlying shares vesting monthly thereafter over 36 months. The stock option was granted pursuant to the Company's 2020 Employment Inducement Incentive Plan, which was approved by the Company's board of directors under Rule 5635(c)(4) of The Nasdaq Global Market for equity grants to induce new employees to enter into employment with the Company.
About Prothena
Prothena Corporation plc is a clinical-stage company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena's partnered programs include prasinezumab (PRX002/RG7935), in collaboration with Roche for the potential treatment of Parkinson's disease and other related synucleinopathies, and programs that target tau, TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of Alzheimer's disease, amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD) or other neurodegenerative diseases. Prothena's proprietary programs include PRX004 for the potential treatment of ATTR amyloidosis, and programs that target Aβ (Amyloid beta) for the potential treatment of Alzheimer's disease. For more information, please visit the Company's website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.
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 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 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.
PROTHENA CORPORATION PLC
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)Three Months Ended
June 30,Six Months Ended
June 30,2020 2019 2020 2019 Collaboration revenue $ 145 $ 167 $ 286 $ 353 License revenue 50 — 50 — Total revenue 195 167 336 353 Operating expenses: Research and development 17,271 9,583 32,519 22,879 General and administrative 9,656 9,081 19,397 18,986 Restructuring credits — — — (61 ) 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 Net loss $ (26,282 ) $ (15,810 ) $ (49,851 ) $ (36,675 ) 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 PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)June 30, December 31, 2020 2019 Assets Cash and cash equivalents $ 333,942 $ 375,723 Accounts receivable 56 68 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 Total assets $ 378,933 $ 419,268 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 Deferred revenue 110,242 110,242 Lease liability, non-current 15,150 17,838 Other non-current liabilities 553 553 Total non-current liabilities 125,945 128,633 Total liabilities 144,489 146,347 Total shareholders' equity 234,444 272,921 Total liabilities and shareholders' equity $ 378,933 $ 419,268 Media and Investor Contact:
Ellen Rose, Head of Communications
650-922-2405, [email protected]
- Net cash used in operating and investing activities was $18.7 million in the second quarter and $41.9 million for the first six months of 2020; quarter-end cash and restricted cash position of $336.6 million provides funding to advance a broad pipeline
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- Phase 2 PASADENA Part 1 study results selected as an oral Top Abstract
DUBLIN, Ireland, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage company with expertise in protein dysregulation and a diverse pipeline of investigational therapeutics for neurodegenerative and rare peripheral amyloid diseases, today announced that results from Part 1 of the Phase 2 PASADENA study of prasinezumab in early Parkinson's disease was selected as an oral Top Abstract presentation at the upcoming virtual International Congress of Parkinson's Disease and Movement Disorders Society (MDS). Prasinezumab is the focus of a worldwide collaboration between Prothena and Roche. In addition, Wagner Zago, PhD, Prothena's Chief Scientific Officer, will participate in a Science of Industry session during MDS.
The PASADENA study results will be presented in the following oral Top Abstract session:
- Session 309: Update on Recent Clinical Trials
- PASADENA: A Phase 2 study to evaluate the safety and efficacy of prasinezumab in early Parkinson's disease; Part 1 Week-52 results
- Presenter: Gennaro Pagano, MD, MSc, PhD, Senior Principal Medical Director, Translational Medicine, Neuroscience and Rare Diseases Discovery and Translational Area, Roche Pharma Research and Early Development
- Session Launch Date and Time: Monday, September 14, 2020; 14:30 – 16:30 GMT; virtual congress sessions will remain available for a limited time after the launch date as an on-demand feature of the virtual congress
- A poster will also be included in the virtual poster hall during the virtual Congress
In addition, Wagner Zago, PhD, Chief Scientific Officer, Prothena, will participate in the following session:
- Session 902: Immunotherapy for Proteinopathies
- Session Launch Date and Time: Tuesday, September 15, 2020; 14:30 – 16:30 GMT
- Session type: Science of Industry (non-CME)
About Prasinezumab
Prasinezumab is a humanized monoclonal antibody under development for the potential treatment of Parkinson's disease. Prasinezumab targets alpha-synuclein and is designed to block the cell-to-cell transmission of the aggregated pathogenic forms of alpha-synuclein in Parkinson's disease, thereby slowing clinical decline. Prior to initiating clinical trials, the efficacy of prasinezumab was evaluated in various cellular and animal models of alpha-synuclein-related disease. In alpha-synuclein transgenic mice, the murine version of prasinezumab, reduced the appearance of alpha-synuclein pathology, protected synapses and halted the worsening of behavioral phenotypes. In December 2013, Prothena and Roche entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including prasinezumab. Prothena has an option to co-promote prasinezumab in the U.S., where the companies share all development and commercialization costs, as well as profits, on a 30/70 basis (30 percent Prothena, 70 percent Roche). Outside the U.S., Roche has sole responsibility for developing and commercializing prasinezumab and has agreed to pay Prothena up to double-digit royalties on net sales. To date, Prothena has earned $75 million of a total potential $600 million that includes clinical, regulatory and sales milestones. For more information on the Phase 2 PASADENA clinical study of prasinezumab in patients with early Parkinson's disease, visit clinicaltrials.gov and search NCT #03100149.
About Parkinson's Disease
Parkinson's disease is a progressive degenerative disorder of the entire nervous system that affects one in 100 people over age 60. An estimated seven to 10 million people are living with Parkinson's disease worldwide. It is the second most common neurodegenerative disorder after Alzheimer's disease. The disease is characterized by the neuronal accumulation of aggregated alpha-synuclein in the CNS and peripheral nervous system that results in a wide spectrum of worsening progressive motor and non-motor symptoms. While diagnosis relies on motor symptoms classically associated with Parkinson's disease, non-motor symptoms may present many years earlier. Current treatments for Parkinson's disease are symptomatic and only address a subset of symptoms such as motor impairment, dementia, or psychosis. There are currently no treatments available that target the underlying cause of the disease and can slow or stop the progression.
About Prothena
Prothena Corporation plc is a clinical-stage company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena's partnered programs include prasinezumab (PRX002/RG7935), in collaboration with Roche for the potential treatment of Parkinson's disease and other related synucleinopathies, and programs that target tau, TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of Alzheimer's disease, amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD) or other neurodegenerative diseases. Prothena's wholly-owned programs include PRX004 for the potential treatment of ATTR amyloidosis, and programs that target Aβ (Amyloid beta) for the potential treatment of Alzheimer's disease. For more information, please visit the Company's website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.
Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential and proposed mechanisms of action of prasinezumab and the expected timing of reporting data from the Phase 2 clinical study of prasinezumab. 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 on March 3, 2020, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. 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.
Media and Investor Contact:
Ellen Rose, Head of Communications
650-922-2405, [email protected] -
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DUBLIN, Ireland, July 30, 2020 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage company with expertise in protein dysregulation and a diverse pipeleine of investigational therapeutics for neurodegenerative and rare peripheral amyloid diseases, announced today that it will report its second quarter and first six months of 2020 financial results on Thursday, August 6, after the close of the U.S. financial markets.
Consistent with past practice, the Company will not be conducting a conference call in conjunction with this financial results release on August 6.
About Prothena
Prothena Corporation plc is a clinical-stage company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena's partnered programs include prasinezumab (PRX002/RG7935), in collaboration with Roche for the potential treatment of Parkinson's disease and other related synucleinopathies, and programs that target tau, TDP-43, and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of Alzheimer's disease, amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD) or other neurodegenerative diseases. Prothena's proprietary programs include PRX004 for the potential treatment of ATTR amyloidosis, and programs that target Aβ (Amyloid beta) for the potential treatment of Alzheimer's disease. For more information, please visit the Company's website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.Media & Investor Contact:
Ellen Rose, Head of Communications
650-922-2405, [email protected] -
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DUBLIN, Ireland, May 27, 2020 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage neuroscience company with expertise in protein misfolding, today announced that members of its senior management team will present and participate in the Jefferies Virtual Healthcare Conference on Wednesday June 3 at 3:30 PM ET.
A webcast of the company presentation can be accessed through the investor relations section of the Company's website at www.prothena.com. Following the presentation, a replay of the webcast will be available on the Company's website for at least 90 days following the presentation date.
About Prothena
Prothena Corporation plc is a clinical-stage neuroscience company with expertise in protein misfolding, focused on the discovery and development of novel therapies with the potential to fundamentally change the course of devastating diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena's partnered programs include prasinezumab (PRX002/RG7935), in collaboration with Roche for the potential treatment of Parkinson's disease and other related synucleinopathies, and programs that target tau, TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of Alzheimer's disease, amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD) or other neurodegenerative diseases. Prothena's proprietary programs include PRX004 for the potential treatment of ATTR amyloidosis, and programs that target Aβ (Amyloid beta) for the potential treatment of Alzheimer's disease. For more information, please visit the Company's website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.
Media and Investor Contact:
Ellen Rose, Head of Communications
650-922-2405, [email protected] -
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- Net cash used in operating and investing activities was $23.2 million in the first quarter; quarter-end cash and restricted cash position of $355.4 million provides funding to advance a broad pipeline
DUBLIN, Ireland, May 06, 2020 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a clinical-stage neuroscience company with expertise in protein misfolding, today reported financial results for the first quarter of 2020. In addition, the Company provided an update on its R&D programs and 2020 financial guidance.
"While the COVID-19 pandemic has brought significant challenges to people around the world and to our industry, Prothena has acted to protect the health of patients and our employees and the continuity of our programs," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "The situation is fluid and continues to evolve and as such we have identified potential disruptions and activated mitigation plans designed to advance our programs even under these challenging circumstances. Our team continues to manage critical activities, exhibiting extraordinary resilience, focus and commitment to advancing our pipeline of novel therapeutics for devastating diseases. We were fortunate that COVID-19 related disruptions began after patients in the Phase 2 prasinezumab study (PASADENA) and the Phase 1 PRX004 study had completed assessments that comprise the primary objective in each study."
First Quarter 2020 and Recent Developments
- The Company continues to monitor the potential impacts of the COVID-19 pandemic to its business. Adaptations to the work environment have been implemented and the Company's laboratories have remained productive. The known and potential impact to active clinical studies is described in more detail below. Prothena has drug supply for its ongoing studies and currently does not expect delays to its programs due to manufacturing or supply chain issues.
- As part of Roche's first quarter earnings announcement, an update was provided on Part 1 of the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson's disease. As updated by Roche, the study did not meet the primary objective, but showed signals of efficacy. These signals were observed on multiple prespecified secondary and exploratory clinical endpoints. Roche has begun further clinical development planning activities and is evaluating the data from Part 1 of the PASADENA study to determine next steps. Based on ongoing evaluation of the data, including potential discussions with health authorities, a further update on prasinezumab is expected later this year.
- In a virtual oral presentation at the Advances in Alzheimer's and Parkinson's Therapies AAT-AD/PD Focus Meeting (AAT-AD/PD), Roche presented baseline data from the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson's disease. The presentation, titled A Phase 2 study to evaluate the safety and efficacy of prasinezumab in early Parkinson's disease (PASADENA): rationale, design and baseline data is posted on www.prothena.com here. The presentation noted that the PASADENA study population can be considered representative of a wider Parkinson's disease population, such as the one studied in the Parkinson's Progression Markers Initiative (PPMI) and is therefore suitable for testing the potential beneficial effect of drugs acting on disease progression, such as prasinezumab.
- The Company appointed Brandon Smith as Chief Business Officer to lead Prothena's business development initiatives, portfolio strategic planning and alliance management activities. Mr. Smith has extensive corporate, business development and operational expertise, and has held a number of executive roles at biotechnology companies.
Research and Development Updates and Upcoming Milestones
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. Based on ongoing evaluation of Part 1 PASADENA study data, including potential discussions with health authorities, a further update on prasinezumab is expected later this year.
- The 52-week blinded extension of the study (Part 2 of the Phase 2 PASADENA Study) is ongoing. Due to the COVID-19 pandemic, patients have missed assessments in Part 2 of the study. The full extent of the COVID-19 disruption to Part 2 is not yet known.
PRX004, a potential treatment for ATTR amyloidosis, is a monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein
- The Phase 1 study of PRX004 is fully enrolled and as of early March patients in all 6 cohorts had received the three infusions and assessments that comprise the dose-escalation portion of the study. Interim data from cohorts 1 through 5 was reported in December.
- At the conclusion of the dose-escalation portion of the study, patients meeting eligibility requirements were provided the option to enroll in the long-term-extension (LTE) portion of the study, which allows for up to 15 additional infusions per patient and is designed to further assess safety, tolerability, pharmacokinetics and pharmacodynamics of PRX004. The LTE also includes certain clinical outcome measures for patients in cohorts 4 through 6 at the month 10 assessment (prior to infusion) and at the end of study (month 19 assessment). As of early April, patients in cohorts 1 through 5 in the LTE had completed at least their month 12 assessment and one patient in cohort 6 had completed their month 10 assessment.
- Because of the disruptions caused by the COVID-19 pandemic, some patients have had to discontinue from the study and most patients in the LTE portion of the study have missed at least one infusion and/or assessment. The Company continues to monitor the impact that COVID-19 will have on the LTE portion of the study based on the fluid circumstances at each of the sites in the United States and Europe. If the COVID-19 pandemic results in missed visits over a prolonged period, it is possible that more patients may not be able to complete the LTE portion of the study.
- The Company believes the study has advanced sufficiently to determine next steps for the program and has begun further clinical development planning activities. The Company currently expects additional data from the dose-escalation and LTE portions of the study, as well as an update on next steps for clinical development, to be reported later this year. This timing, however, is dependent on any additional impacts of COVID-19.
Discovery and Preclinical Development: Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications
- 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
First Quarter 2020 Financial Results and Updated 2020 Financial Guidance
For the first quarter of 2020, Prothena reported a net loss of $23.6 million, as compared to a net loss of $20.9 million for the first quarter of 2019, which included a restructuring credit of $0.1 million in the first quarter of 2019 resulting from an adjustment in previously recorded employee termination benefits associated with the discontinuation of the NEOD001 program. Net loss per share for the first quarter of 2020 was $0.59, as compared to a net loss per share of $0.52 for the first quarter of 2019.
Prothena reported total revenue, all from its collaboration with Roche, of $0.1 million for the first quarter of 2020, as compared to total revenue of $0.2 million for the first quarter of 2019.
Research and development (R&D) expenses totaled $15.2 million for the first quarter of 2020, as compared to $13.3 million for the first quarter of 2019. The increase in R&D expense for the first quarter of 2020 compared to the same period in the prior year was primarily due to higher collaboration expense with Roche, higher manufacturing costs (primarily related to the tau and Aβ programs) and higher clinical trial costs (primarily associated with the PRX004 program). R&D expenses included non-cash share-based compensation expense of $2.0 million for the first quarter of 2020, as compared to $2.1 million for the first quarter of 2019.
General and administrative (G&A) expenses totaled $9.7 million for the first quarter of 2020, as compared to $9.9 million for first quarter of 2019. G&A expenses for the first quarter of 2020 decreased compared to the same period in the prior year primarily related to lower personnel costs (including share-based compensation expense), and lower legal and accounting fees, which was offset in part by higher costs for our director and officer insurance premiums. G&A expenses included non-cash share-based compensation expense of $3.5 million for the first quarter of 2020, as compared to $4.1 million for the first quarter of 2019.
Total non-cash share-based compensation expense was $5.5 million for the first quarter of 2020, as compared to $6.2 million for the first quarter of 2019.
As of March 31, 2020, Prothena had $355.4 million in cash, cash equivalents and restricted cash and no debt.
As of May 1, 2020, Prothena had approximately 39.9 million ordinary shares outstanding.
The Company is updating its projected full year 2020 net cash burn from operating and investing activities, and expects it to be $75 to $85 million (versus prior guidance of $60 to $76 million), and expects to end the year with approximately $299 million (midpoint) in cash, cash equivalents and restricted cash (cash position), representing a decrease of $11 million from prior guidance of $310 million (midpoint). This decrease in cash position is primarily driven by an increase in expenses related to further clinical development, planning activities and ongoing evaluation of data from the Phase 2 PASADENA study of prasinezumab, and is based on Prothena's 30% portion of the U.S. co-development expenses. The updated estimated full year 2020 net cash burn from operating and investing activities is primarily driven by an updated estimated net loss of $101 to $118 million (versus prior guidance of $84 to $106 million), which includes an estimated $23 million of non-cash share-based compensation expense.
About Prothena
Prothena Corporation plc is a clinical-stage neuroscience company with expertise in protein misfolding, focused on the discovery and development of novel therapies with the potential to fundamentally change the course of devastating diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena's partnered programs include prasinezumab (PRX002/RG7935), in collaboration with Roche for the potential treatment of Parkinson's disease and other related synucleinopathies, and programs that target tau, TDP-43 and an undisclosed target in collaboration with Bristol-Myers Squibb for the potential treatment of Alzheimer's disease, amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD) or other neurodegenerative diseases. Prothena's proprietary programs include PRX004 for the potential treatment of ATTR amyloidosis, and programs that target Aβ (Amyloid beta) for the potential treatment of Alzheimer's disease. For more information, please visit the Company's website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.
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 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 ongoing 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; 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 Securities and Exchange Commission. 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.
PROTHENA CORPORATION PLC
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited - amounts in thousands except per share data)Three Months Ended
March 31,2020 2019 Collaboration revenue $ 141 $ 186 Total revenue 141 186 Operating expenses: Research and development 15,248 13,296 General and administrative 9,741 9,905 Restructuring credits — (61 ) Total operating expenses 24,989 23,140 Loss from operations (24,848 ) (22,954 ) Other income, net 1,113 2,287 Loss before income taxes (23,735 ) (20,667 ) Provision for (benefit from) income taxes (166 ) 198 Net loss $ (23,569 ) $ (20,865 ) Basic and diluted net loss per share $ (0.59 ) $ (0.52 ) Shares used to compute basic and diluted net loss per share 39,909 39,864
PROTHENA CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(unaudited - amounts in thousands)March 31, December 31, 2020 2019 Assets Cash and cash equivalents $ 352,685 $ 375,723 Accounts receivable 174 68 Prepaid expenses and other current assets 6,832 2,584 Total current assets 359,691 378,375 Property and equipment, net 3,531 3,874 Operating lease right-of-use assets 21,929 23,274 Restricted cash, non-current 2,704 2,704 Other non-current assets 11,566 11,041 Total non-current assets 39,730 40,893 Total assets $ 399,421 $ 419,268 Liabilities and Shareholders' Equity Accrued research and development $ 5,223 $ 5,826 Lease liability, current 5,202 5,101 Other current liabilities 6,661 6,787 Total current liabilities 17,086 17,714 Deferred revenue 110,242 110,242 Lease liability, non-current 16,501 17,838 Other non-current liabilities 553 553 Total non-current liabilities 127,296 128,633 Total liabilities 144,382 146,347 Total shareholders' equity 255,039 272,921 Total liabilities and shareholders' equity $ 399,421 $ 419,268 Media and Investor Contact:
Ellen Rose, Head of Communications
650-922-2405, [email protected] - Net cash used in operating and investing activities was $23.2 million in the first quarter; quarter-end cash and restricted cash position of $355.4 million provides funding to advance a broad pipeline