Passage Bio Reports First Quarter 2023 Financial Results and Provides Recent Business Highlights
11 May 2023 - 9:00PM
Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic
medicines company focused on developing transformative therapies
for central nervous system (CNS) disorders, today reported
financial results for the first quarter ended March 31, 2023 and
provided recent business highlights.
“Over the last quarter, we have maintained a steady focus on the
successful execution of our two lead clinical programs, taking the
necessary steps to ensure the achievement of our upcoming
milestones,” said William Chou, M.D., president and chief executive
officer of Passage Bio. “In our Imagine-1 study for GM1
gangliosidosis, we expect to report safety and biomarker data for
Cohort 4 by mid-year and begin dosing patients at a third, higher
dose in the second half of this year. For FTD, we have expanded our
recruitment sites to accelerate enrollment and look forward to
reporting initial safety and biomarker data from Cohort 1 by
year-end. Our disciplined approach and judicious cash management
gives us confidence that we can deliver long-term value for
patients and exemplifies our commitment to develop transformative
therapies for people with devastating CNS disorders.”
Recent Highlights
- Submitted protocol amendment
for Imagine-1 study to treat patients at a higher dose (Dose 3) of
PBGM01: The Imagine-1 clinical trial protocol amendment
intends to treat early and late infantile GM1 gangliosidosis
patients at a higher dose (Dose 3), which is two times higher than
the current high dose (Dose 2). Following regulatory review, the
company looks forward to resuming patient enrollment efforts and
expects to the dose the first patient at Dose 3 in the second half
of the year.
- Initiated additional site in
global Phase 1/2 upliFT-D trial of PBFT02 for the treatment of
patients with FTD with granulin mutations (GRN): The
company initiated a fourth site in April and remains focused on
opening additional sites throughout the year. Enrollment is
progressing globally, and initial safety and biomarker data from
Cohort 1 patients continues to be expected in the second half of
2023.
Anticipated Upcoming Milestones
- Present initial safety and biomarker data from Cohort 4 (early
infantile, high dose) in the Imagine-1 clinical trial for GM1 in
mid-2023.
- Dose first patient at higher dose (Dose 3) in Imagine-1
clinical trial for GM1 in the second half of 2023.
- Present initial safety and biomarker data for Cohort 1 in
upliFT-D clinical trial for FTD in the second half of 2023.
First Quarter 2023 Financial Results
- Cash Position: Cash, cash equivalents and
marketable securities were $167.8 million as of March 31, 2023, as
compared to $267.1 million as of March 31, 2022. The Company
expects current cash, cash equivalents and marketable securities to
fund operations into the first half of 2025.
- Research and Development (R&D)
Expenses: R&D expenses were $16.8 million for the
quarter ended March 31, 2023, as compared to $26.2 million for the
same quarter in 2022. The decrease in R&D expenses was
primarily due to decreases in clinical manufacturing expenses,
wages and benefits expenses and share-based compensation
expense.
- General and Administrative (G&A)
Expenses: G&A expenses were $19.0 million for the
quarter ended March 31, 2023, as compared to $15.1 million for the
same quarter in 2022. The increase in G&A expenses was
primarily due to non-recurring expenses related to amendments to
the company’s agreements with Catalent, which was partially offset
by decreases in wages and benefits expense, share-based
compensation expense and other expenses. Excluding the
non-recurring expenses related to the Catalent amendments, G&A
expenses decreased by $7.4 million.
- Net Loss: Net loss was $34.3 million, or
a net loss of $0.63 per basic and diluted share, for the quarter
ended March 31, 2023, compared to $42.8 million, or a net loss of
$0.79 per basic and diluted share, for the same quarter in
2022.
About Passage Bio Passage Bio (Nasdaq: PASG) is
a clinical-stage genetic medicines company on a mission to provide
life-transforming therapies for patients with CNS diseases with
limited or no approved treatment options. Our portfolio spans
pediatric and adult CNS indications, and we are currently advancing
clinical programs in GM1 gangliosidosis and frontotemporal dementia
and our preclinical pipeline, including programs in amyotrophic
lateral sclerosis and Huntington’s disease. Based in Philadelphia,
PA, our company has established a strategic collaboration and
licensing agreement with the renowned University of Pennsylvania’s
Gene Therapy Program to conduct our discovery and IND-enabling
preclinical work. Through this collaboration, we have enhanced
access to a broad portfolio of gene therapy candidates and future
gene therapy innovations that we then pair with our deep clinical,
regulatory, manufacturing and commercial expertise to rapidly
advance our robust pipeline of optimized gene therapies. As we work
with speed and tenacity, we are always mindful of patients who may
be able to benefit from our therapies. More information is
available at www.passagebio.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of, and made
pursuant to the safe harbor provisions of, the Private Securities
Litigation Reform Act of 1995, including, but not limited to: our
expectations about timing and execution of anticipated milestones,
including progress of clinical trials and the availability of
clinical data from such trials; our expectations about our
collaborators’ and partners’ ability to execute key initiatives;
our expectations about manufacturing plans and strategies; our
expectations about cash runway; and the ability of our lead product
candidates to treat their respective target CNS
disorders. These forward-looking statements may be accompanied
by such words as “aim,” “anticipate,” “believe,” “could,”
“estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,”
“plan,” “potential,” “possible,” “will,” “would,” and other words
and terms of similar meaning. These statements involve risks
and uncertainties that could cause actual results to differ
materially from those reflected in such statements, including: our
ability to develop and obtain regulatory approval for our product
candidates; the timing and results of preclinical studies and
clinical trials; risks associated with clinical trials, including
our ability to adequately manage clinical activities, unexpected
concerns that may arise from additional data or analysis obtained
during clinical trials, regulatory authorities may require
additional information or further studies, or may fail to approve
or may delay approval of our drug candidates; the occurrence of
adverse safety events; the risk that positive results in a
preclinical study or clinical trial may not be replicated in
subsequent trials or success in early stage clinical trials may not
be predictive of results in later stage clinical trials; failure to
protect and enforce our intellectual property, and other
proprietary rights; our dependence on collaborators and other third
parties for the development and manufacture of product candidates
and other aspects of our business, which are outside of our full
control; risks associated with current and potential delays or work
stoppages; and the other risks and uncertainties that are described
in the Risk Factors section in documents the company files from
time to time with the Securities and Exchange
Commission (SEC), and other reports as filed with
the SEC. Passage Bio undertakes no obligation to
publicly update any forward-looking statement, whether written or
oral, that may be made from time to time, whether as a result of
new information, future developments or otherwise.
|
Passage Bio, Inc. |
Balance Sheets |
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
(in thousands, except share data and per share
data) |
|
March 31, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
33,372 |
|
|
$ |
34,601 |
|
Marketable securities |
|
|
134,402 |
|
|
|
155,009 |
|
Prepaid expenses and other current assets |
|
|
1,685 |
|
|
|
926 |
|
Prepaid research and development |
|
|
2,162 |
|
|
|
6,508 |
|
Total current assets |
|
|
171,621 |
|
|
|
197,044 |
|
Property and equipment,
net |
|
|
21,599 |
|
|
|
22,515 |
|
Right of use assets -
operating leases |
|
|
19,590 |
|
|
|
19,723 |
|
Other assets |
|
|
433 |
|
|
|
4,267 |
|
Total assets |
|
$ |
213,243 |
|
|
$ |
243,549 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,033 |
|
|
$ |
4,065 |
|
Accrued expenses and other current liabilities |
|
|
10,907 |
|
|
|
11,011 |
|
Operating lease liabilities |
|
|
3,303 |
|
|
|
3,275 |
|
Total current liabilities |
|
|
17,243 |
|
|
|
18,351 |
|
Operating lease liabilities -
noncurrent |
|
|
23,649 |
|
|
|
23,832 |
|
Other liabilities |
|
|
2,000 |
|
|
|
- |
|
Total liabilities |
|
|
42,892 |
|
|
|
42,183 |
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value: 300,000,000 shares authorized;
54,626,690 shares issued and outstanding at
March 31, 2023 and 54,614,690 shares issued and
outstanding at December 31, 2022 |
|
|
5 |
|
|
|
5 |
|
Additional paid in capital |
|
|
697,517 |
|
|
|
694,733 |
|
Accumulated other comprehensive income (loss) |
|
|
(427 |
) |
|
|
(966 |
) |
Accumulated deficit |
|
|
(526,744 |
) |
|
|
(492,406 |
) |
Total stockholders’ equity |
|
|
170,351 |
|
|
|
201,366 |
|
Total liabilities and stockholders’ equity |
|
$ |
213,243 |
|
|
$ |
243,549 |
|
|
|
|
|
|
|
|
|
|
Passage Bio, Inc. |
Statements of Operations and Comprehensive
Loss |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
(in thousands, except share and per share
data) |
|
2023 |
|
2022 |
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
16,836 |
|
|
$ |
26,213 |
|
Acquired in-process research and development |
|
|
— |
|
|
|
1,500 |
|
General and administrative |
|
|
19,047 |
|
|
|
15,099 |
|
Loss from operations |
|
|
(35,883 |
) |
|
|
(42,812 |
) |
Other income (expense),
net |
|
|
1,545 |
|
|
|
1 |
|
Net loss |
|
$ |
(34,338 |
) |
|
$ |
(42,811 |
) |
Per share information: |
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.63 |
) |
|
$ |
(0.79 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
54,618,799 |
|
|
|
54,275,751 |
|
Comprehensive loss: |
|
|
|
|
|
|
Net loss |
|
$ |
(34,338 |
) |
|
$ |
(42,811 |
) |
Unrealized gain (loss) on marketable securities |
|
|
539 |
|
|
|
(921 |
) |
Comprehensive loss |
|
$ |
(33,799 |
) |
|
$ |
(43,732 |
) |
|
|
|
|
|
|
|
|
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For further information, please contact:
Investors:Stuart HendersonPassage
Bio267.866.0114shenderson@passagebio.com
Media:Mike BeyerSam Brown Inc. Healthcare
Communications312.961.2502MikeBeyer@sambrown.com
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