Prevail Therapeutics Reports Second Quarter 2019 Financial Results and Recent Business Highlights
August 14 2019 - 7:00AM
Prevail Therapeutics Inc. (NASDAQ: PRVL), a biotechnology company
developing potentially disease-modifying AAV-based gene therapies
for patients with neurodegenerative disorders, today reported
financial results for the second quarter ended June 30, 2019 and
provided an update on recent business highlights.
“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 $202 million following our $125 million IPO
in June enables us to continue advancing PR001 and to initiate
additional clinical trials, including for our second gene therapy
candidate, PR006, for the treatment of frontotemporal dementia
patients with a progranulin mutation.”
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 the U.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 the FDA 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 in June 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 of Yong 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
appointed Tim Adams, Chief Financial Officer of ObsEva, to its
Board of Directors and as Audit Committee Chair, and expanded the
role of Board member Francois 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 of June 30, 2019, as compared to $63.0 million as
of December 31, 2018.
- R&D Expenses: Research and development
(R&D) expenses were $20.4 million for the six months ended June
30, 2019, compared to $4.5 million for the six months ended June
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 in REGENXBIO license
fees.
- G&A Expenses: General and administrative
(G&A) expenses were $5.6 million for the six months ended June
30, 2019, compared to $1.6 million for the six months ended June
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 ended June 30, 2019, compared to
$7.1 million, or $0.42 loss per share, for the six months ended
June 30, 2018.
Second Quarter 2019 Financial Results
- Cash Position: Cash and cash equivalents were
$202.1 million as of June 30, 2019, as compared to $100.3 million
as of March 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 in REGENXBIO
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 Prevail TherapeuticsPrevail Therapeutics
is a gene therapy company leveraging breakthroughs in human
genetics with the goal of developing and commercializing
disease-modifying AAV-based gene therapies for patients with
neurodegenerative diseases. Prevail was founded by Dr. Abeliovich
in 2017, through a collaborative effort with The Silverstein
Foundation for Parkinson’s with GBA and OrbiMed, and is
headquartered in New York, NY.
Forward-Looking StatementsStatements 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 FDA to support Prevail’s
clinical development plans; and the timing of initiation of
Prevail’s Phase 1/2 clinical trials of PR001 and PR006. Because
such statements are subject to risks and uncertainties, actual
results may differ materially from those expressed or implied by
such forward-looking statements. These risks and uncertainties
include, among others: Prevail’s novel approach to gene
therapy makes it difficult to predict the time, cost and potential
success of product candidate development or regulatory approval;
PR001 or Prevail’s other gene therapy programs may not meet safety
and efficacy levels needed to support ongoing clinical development
or regulatory approval; and the regulatory landscape for gene
therapy is rigorous, complex, uncertain and subject to change.
These and other risks are described more fully in Prevail’s filings
with the Securities and Exchange Commission (SEC), including
the “Risk Factors” section of the Company’s final prospectus for
its initial public offering, filed with the SEC on June 20, 2019,
and its other documents subsequently filed with or furnished to the
SEC. All forward-looking statements contained in this press release
speak only as of the date on which they were made. Except to the
extent required by law, Prevail undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
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, |
|
|
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 |
|
Media Contact:Katie Engleman1AB
katie@1ABmedia.com
Investor Contact:
investors@prevailtherapeutics.com
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