Prevail Therapeutics Reports Second Quarter 2019 Financial Results and Recent Business Highlights
IND Active for Phase 1/2 Trial of PR001 to Treat Parkinson’s Disease Patients with GBA1 Mutations
Successful
“Since Prevail’s inception in 2017, we have made rapid progress toward our goal of bringing urgently needed therapies to patients with Parkinson’s disease and other neurodegenerative disorders. With the first IND active for our lead gene therapy program, PR001, in Parkinson’s disease with a GBA1 mutation, we are one step closer to our goal, and remain focused on initiating a Phase 1/2 clinical trial of PR001 before the end of this year,” said Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail. “Our strong cash balance of
Recent Business Highlights
- IND Active for PR001: In
May 2019 , Prevail’s Investigational New Drug Application (IND) for its lead gene therapy candidate, PR001, for the treatment of Parkinson’s disease patients with a GBA1 mutation (PD-GBA) was accepted by theU.S. Food and Drug Administration (FDA ) and is now active. Clinical site activation is ongoing, with patient dosing on track for the fourth quarter of 2019.
- Fast Track Designation Received for PR001: In
July 2019 , Prevail announced that theFDA granted Fast Track Designation for PR001 for the treatment of PD-GBA.
- Preclinical Development of PR006 for Frontotemporal Dementia Patients with a GRN Mutation (FTD-GRN) advanced: Based on pre-IND regulatory interaction with the
FDA inJune 2019 , Prevail intends to initiate its Phase 1/2 clinical trial in FTD-GRN patients in the first half of 2020. Prevail believes PR006 has the potential to be a first-in-class, disease-modifying treatment for patients with FTD-GRN.
- Leadership Team Strengthened and Board of Directors Expanded to Support Growth: In
May 2019 , Prevail announced the promotion ofYong Dai , Ph.D., to Chief Technology Officer. Dr. Dai will lead the Company’s process and analytical development and establish advanced manufacturing. In addition, the Company appointedTim Adams , Chief Financial Officer ofObsEva , to its Board of Directors and as Audit Committee Chair, and expanded the role of Board memberFrancois Nader , M.D. to Non-Executive Chairman.
- Successful Completion of Initial Public Offering: In
July 2019 , Prevail announced the closing of its initial public offering at a price to the public of$17.00 per share. The Company raised$125.0 million in aggregate gross proceeds to support the advancement of its three initial gene therapy programs and business operations.
Year to Date 2019 Financial Results
- Cash Position: Cash and cash equivalents were
$202.1 million as ofJune 30, 2019 , as compared to$63.0 million as ofDecember 31, 2018 .
- R&D Expenses: Research and development (R&D) expenses were
$20.4 million for the six months endedJune 30, 2019 , compared to$4.5 million for the six months endedJune 30, 2018 . The increase was primarily due to a$11.2 million increase in external research and development expenses, a$3.2 million increase in personnel costs resulting from increased headcount, and a$1.5 million increase inREGENXBIO license fees.
- G&A Expenses: General and administrative (G&A) expenses were
$5.6 million for the six months endedJune 30, 2019 , compared to$1.6 million for the six months endedJune 30, 2018 . The increase was primarily due to a$1.8 million increase in personnel costs resulting from increased headcount, a$1.7 million increase in consulting and professional service fees and other expenses, and a$0.5 million increase in facility rent expense.
- Net Loss: Net loss was
$25.0 million , or$1.05 loss per share, for the six months endedJune 30, 2019 , compared to$7.1 million , or$0.42 loss per share, for the six months endedJune 30, 2018 .
Second Quarter 2019 Financial Results
- Cash Position: Cash and cash equivalents were
$202.1 million as ofJune 30, 2019 , as compared to$100.3 million as ofMarch 31, 2019 .
- R&D Expenses: R&D expenses were
$12.0 million for the second quarter of 2019, compared to$3.2 million for the second quarter of 2018. The increase is primarily due to a$6.3 million increase in external research and development expenses, a$1.3 million increase in personnel costs resulting from increased headcount, and a$1.2 million increase inREGENXBIO license fee.
- G&A Expenses: G&A expenses were
$3.7 million for the second quarter of 2019, compared to$1.0 million for the second quarter of 2018. The increase is primarily due to a$1.4 million increase in personnel costs resulting from increased headcount, a$0.9 million increase in consulting and professional services fees and other expenses, and a$0.4 million increase in facility rent expense.
- Net Loss: Net loss was
$15.1 million , or$0.58 loss per share, for the second quarter of 2019, compared to$3.9 million , or$0.19 loss per share, for the second quarter of 2018.
About
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the ability of Prevail’s balance sheet to enable continued development of its product candidates; the anticipated use of proceeds from Prevail’s initial public offering; the likelihood of its interactions with the
Prevail Therapeutics Inc. | |||||||||||||||
Statements of Operations | |||||||||||||||
(Unaudited) | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
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2019 | 2018 | 2019 | 2018 | ||||||||||||
Operating Expenses: | |||||||||||||||
Research and development | $ | 11,955 | $ | 3,207 | $ | 20,366 | $ | 4,511 | |||||||
General and administrative | 3,713 | 959 | 5,598 | 1,600 | |||||||||||
Total operating loss | (15,668 | ) | (4,166 | ) | (25,964 | ) | (6,111 | ) | |||||||
Change in fair value of derivative liabilities | — | — | — | (781 | ) | ||||||||||
Interest income | 565 | 222 | 916 | 222 | |||||||||||
Interest expense | — | — | — | (471 | ) | ||||||||||
Total other income (expense), net | 565 | 222 | 916 | (1,030 | ) | ||||||||||
Net loss | $ | (15,103 | ) | $ | (3,944 | ) | $ | (25,048 | ) | $ | (7,141 | ) | |||
Net loss per share, basic and diluted | $ | (0.58 | ) | $ | (0.19 | ) | $ | (1.05 | ) | $ | (0.42 | ) | |||
Weighted average shares outstanding, basic and diluted |
26,212,356 | 20,326,716 | 23,945,198 | 16,970,543 |
Prevail Therapeutics Inc. | ||||||||
Balance Sheets | ||||||||
(Unaudited) | ||||||||
(in thousands, except share and per share data) | ||||||||
June 30, 2019 |
December 31, 2018 |
|||||||
ASSETS | ||||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | $ | 202,095 | $ | 63,014 | ||||
Prepaid expenses and other current assets | 4,253 | 563 | ||||||
Total current assets | 206,348 | 63,577 | ||||||
Property and equipment, net | 2,123 | 678 | ||||||
Operating lease right-of-use assets | 7,516 | 8,534 | ||||||
Restricted cash | 91 | 91 | ||||||
TOTAL ASSETS | $ | 216,078 | $ | 72,880 | ||||
LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ EQUITY (DEFICIT) |
||||||||
CURRENT LIABILITIES: | ||||||||
Accounts payable | $ | 2,003 | $ | 1,241 | ||||
Accrued expenses and other current liabilities | 4,555 | 1,477 | ||||||
Operating lease liabilities | 1,101 | 917 | ||||||
Total current liabilities | 7,659 | 3,635 | ||||||
Long-term operating lease liabilities | 7,380 | 7,952 | ||||||
TOTAL LIABILITIES | 15,039 | 11,587 | ||||||
COMMITMENTS AND CONTINGENCIES (Note 13) REDEEMABLE CONVERTIBLE PREFERRED STOCK |
||||||||
Series Seed preferred stock - $0.0001 par value, 0 and 6,480,000 shares authorized, issued, and outstanding as of June 30, 2019 and December 31, 2018, respectively |
— | 3,524 | ||||||
Series A preferred stock - $0.0001 par value, 0 and 9,072,000 shares authorized, 0 and 8,997,085 shares issued, and outstanding as of June 30, 2019 and December 31, 2018, respectively |
— | 76,186 | ||||||
STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
Common stock - $0.0001 par value, 200,000,000 and 28,398,600 shares authorized as of June 30, 2019 and December 31, 2018, respectively, 34,021,194 and 7,209,000 shares issued and outstanding as of June 30, 2019 and December 31, 2018 |
3 | 1 | ||||||
Additional paid-in capital | 246,998 | 2,496 | ||||||
Accumulated deficit | (45,962 | ) | (20,914 | ) | ||||
Total stockholders’ equity (deficit) | 201,039 | (18,417 | ) | |||||
TOTAL LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS’ EQUITY (DEFICIT) |
$ | 216,078 | $ | 72,880 |
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Source: Prevail Therapeutics