On November 4, 2020 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with expertise in protein dysregulation and a diverse pipeline of investigational therapeutics for neurodegenerative and rare peripheral amyloid diseases, reported financial results for the third quarter and first nine months of 2020 (Press release, Prothena, NOV 4, 2020, View Source [SID1234569993]). In addition, the Company provided an update on its R&D programs.
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"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 Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "Moving into the fourth quarter, we are building on this momentum with two new data presentations from our Alzheimer’s disease portfolio at CTAD 2020 this week and additional data from our Phase 1 study of PRX004 in ATTR amyloidosis is expected later this quarter. Looking ahead, we remain focused on advancing our R&D pipeline towards key milestones."
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 Congress 2020 (MDS Congress 2020) 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 Prothena will 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 Conference 2020 (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.
Upcoming Research and Development 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 2 of the Phase 2 PASADENA study (a 52-week blinded extension phase) is ongoing.
Prothena will earn a $60 million clinical 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
Prothena expects to report new data in fourth quarter of this year from the dose-escalation and available LTE portion of the study.
Prothena continues 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: Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications
Prothena continues 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.
Prothena has 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 Conference on Tuesday November 17, 2020 at 4:00 PM Eastern Time
Jefferies Virtual London Healthcare Conference on Thursday November 19, 2020 at 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, Prothena reported a net loss of $30.6 million and $80.4 million, respectively, as compared to a net loss of $19.4 million and $56.1 million for the third quarter and first nine months of 2019, respectively. The third quarter and first nine 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 third quarter and first nine months of 2020 was $0.77 and $2.02, respectively, as compared to a net loss per share of $0.49 and $1.41 for the third quarter and first nine months of 2019, respectively.
Prothena reported total revenue, primarily from its collaboration with Roche, of $0.2 million and $0.5 million for the third quarter and first nine months of 2020, respectively as compared to total revenue of $0.2 million and $0.6 million for the third quarter and first nine months of 2019, respectively.
Research and development (R&D) expenses totaled $21.6 million and $54.1 million for the third quarter and first nine months of 2020, respectively, as compared to $12.5 million and $35.4 million for the third quarter and first nine months of 2019, respectively. The increase in R&D expense for the third quarter and first nine months of 2020 compared to the same periods in the prior year was primarily due to higher manufacturing costs, higher collaboration expense with Roche related to the prasinezumab program and higher R&D consulting expense. R&D expenses included non-cash share-based compensation expense of $2.1 million and $6.2 million for the third quarter and first nine months of 2020, respectively, as compared to $2.0 million and $6.2 million for the third quarter and first nine months of 2019, respectively.
General and administrative (G&A) expenses totaled $9.4 million and $28.8 million for the third quarter and first nine months of 2020, respectively, as compared to $8.7 million and $27.7 million for the third quarter and first nine months of 2019, respectively. The increase in G&A expenses for the third quarter and first nine months of 2020 compared to the same periods in the prior year was primarily related to higher costs for our director and officer insurance premiums offset in part by lower share-based compensation expense. G&A expenses included non-cash share-based compensation expense of $3.5 million and $10.6 million for the third quarter and first nine months of 2020, respectively, as compared to $3.9 million and $12.1 million for the third quarter and first nine months of 2019, respectively.
Total non-cash share-based compensation expense was $5.6 million and $16.8 million for the third quarter and first nine months of 2020, respectively, as compared to $5.8 million and $18.3 million for the third quarter and first nine months of 2019, respectively.
As of September 30, 2020, Prothena had $317.2 million in cash, cash equivalents and restricted cash and no debt.
As of October 30, 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 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 $11.03, which was the closing trading price on November 2, 2020, the date of the grants. The inducement awards will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the date of grants and 1/48th of the underlying shares vesting monthly thereafter over 36 months. The options were 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.