Passage Bio Reports Third Quarter 2023 Financial Results and Provides Recent Business Highlights
November 13 2023 - 6:00AM
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 third quarter ended September 30, 2023,
and provided recent business highlights.
"Our team remains focused on execution, and this past quarter
marked another stride toward achieving key milestones across our
two lead clinical programs. Notably for FTD, we're encouraged by
the initial patient data showing the translation of preclinical
studies into the clinic. As these data emerge, we are also
evaluating the potential of extending the reach of PBFT02 to treat
patients with other adult neurodegenerative conditions in which
progranulin is thought to play a role,” said William Chou, M.D.,
president and chief executive officer of Passage Bio. "Furthermore,
the continued treatment of patients in our GM1 trial is a testament
to our team’s operational excellence. Our sustained progress across
clinical programs, combined with the company’s robust financial
position and the anticipation of impactful clinical data in the
upcoming year, puts us squarely on the path to achieve our mission
of developing transformative therapies for people with devastating
CNS disorders.”
Recent Highlights
- Continued advancement of global Phase 1/2 upliFT-D
trial of PBFT02 for the treatment of patients with frontotemporal
dementia (FTD) with granulin mutations
(GRN): The company
continues to experience momentum across the FTD program, with six
clinical trial sites initiated across Brazil, Canada, and the
United States and additional clinical trial sites in Europe
expected to come online in the coming months. Patient
identification and recruitment initiatives have proven to be
effective, with multiple GRN+ patients identified and being
evaluated for eligibility across global trial sites. Initial data
focused on safety and CSF progranulin levels from three Cohort 1
patients is expected in the fourth quarter of 2023.
- Strong clinical execution
leads to the treatment of multiple patients at Dose 3 in global
Phase 1/2 Imagine-1 clinical trial for GM1: Patient
recruitment of early and late infantile GM1 patients to be treated
at the highest dose level, Dose 3, continues to progress well. The
company remains on track to report initial safety and biomarker
data from Dose 3 patients by mid-2024.
- Cash runway into Q4 2025: Following a
reallocation of resources completed in July, the company has
extended its cash runway into the fourth quarter of 2025. This
strategic financial management ensures that sufficient resources
are available to continue delivering on meaningful clinical data
from ongoing research and development efforts. The company remains
steadfast in its commitment to prudent resource allocation.
Anticipated Upcoming Milestones
- Present initial safety and biomarker
data from three Cohort 1 patients in upliFT-D clinical trial for
FTD in Q4 2023.
- Present initial safety and biomarker
data from Dose 3 patients in Imagine-1 clinical trial for GM1 in
mid-2024.
Third Quarter 2023 Financial Results
- Cash Position: Cash, cash equivalents and
marketable securities were $132.8 million as of September 30, 2023,
as compared to $213.8 million as of September 30, 2022. The Company
expects current cash, cash equivalents and marketable securities to
fund operations into Q4 2025.
- Research and Development (R&D)
Expenses: R&D expenses were $15.1 million for the
quarter ended September 30, 2023, as compared to $15.4 million as
of September 30, 2022.
- General and Administrative (G&A)
Expenses: G&A expenses were $8.2 million for the
quarter ended September 30, 2023, as compared to $10.7 million as
of September 30, 2022. The decrease primarily relates to decreases
in employee compensation costs and facility and other expenses, as
a result of our reductions in workforce.
- Net Loss: Net loss was $27.1 million, or
a net loss of $0.49 per basic and diluted share, for the quarter
ended September 30, 2023, compared to $26.7 million, or a net loss
of $0.49 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 the 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
monogenic 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, work
stoppages, or supply chain disruptions; 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 and per share
data) |
|
September 30, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
33,579 |
|
|
$ |
34,601 |
|
Marketable securities |
|
|
99,201 |
|
|
|
155,009 |
|
Prepaid expenses and other current assets |
|
|
1,282 |
|
|
|
926 |
|
Prepaid research and development |
|
|
1,649 |
|
|
|
6,508 |
|
Total current assets |
|
|
135,711 |
|
|
|
197,044 |
|
Property and equipment,
net |
|
|
16,067 |
|
|
|
22,515 |
|
Right of use assets -
operating leases |
|
|
17,045 |
|
|
|
19,723 |
|
Other assets |
|
|
433 |
|
|
|
4,267 |
|
Total assets |
|
$ |
169,256 |
|
|
$ |
243,549 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,749 |
|
|
$ |
4,065 |
|
Accrued expenses and other current liabilities |
|
|
13,713 |
|
|
|
11,011 |
|
Operating lease liabilities |
|
|
3,349 |
|
|
|
3,275 |
|
Total current liabilities |
|
|
19,811 |
|
|
|
18,351 |
|
Operating lease liabilities -
noncurrent |
|
|
23,169 |
|
|
|
23,832 |
|
Total liabilities |
|
|
42,980 |
|
|
|
42,183 |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value: 300,000,000 shares authorized;
54,812,972 shares issued and outstanding at
September 30, 2023 and 54,614,690 shares issued and
outstanding at December 31, 2022 |
|
|
5 |
|
|
|
5 |
|
Additional paid‑in capital |
|
|
704,173 |
|
|
|
694,733 |
|
Accumulated other comprehensive income (loss) |
|
|
(192 |
) |
|
|
(966 |
) |
Accumulated deficit |
|
|
(577,710 |
) |
|
|
(492,406 |
) |
Total stockholders’ equity |
|
|
126,276 |
|
|
|
201,366 |
|
Total liabilities and stockholders’ equity |
|
$ |
169,256 |
|
|
$ |
243,549 |
|
Passage
Bio, Inc.Statements of Operations and
Comprehensive Loss(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
(in thousands, except share and per share
data) |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
15,098 |
|
|
$ |
15,362 |
|
|
$ |
49,258 |
|
|
$ |
68,396 |
|
Acquired in‑process research and development |
|
|
— |
|
|
|
1,500 |
|
|
|
— |
|
|
|
3,000 |
|
General and administrative |
|
|
8,184 |
|
|
|
10,664 |
|
|
|
35,295 |
|
|
|
38,754 |
|
Impairment of long-lived assets |
|
|
5,390 |
|
|
|
— |
|
|
|
5,390 |
|
|
|
— |
|
Loss from operations |
|
|
(28,672 |
) |
|
|
(27,526 |
) |
|
|
(89,943 |
) |
|
|
(110,150 |
) |
Other income (expense),
net |
|
|
1,562 |
|
|
|
825 |
|
|
|
4,639 |
|
|
|
1,096 |
|
Net loss |
|
$ |
(27,110 |
) |
|
$ |
(26,701 |
) |
|
$ |
(85,304 |
) |
|
$ |
(109,054 |
) |
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.49 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.56 |
) |
|
$ |
(2.01 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
54,789,410 |
|
|
|
54,473,945 |
|
|
|
54,697,967 |
|
|
|
54,379,397 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(27,110 |
) |
|
$ |
(26,701 |
) |
|
$ |
(85,304 |
) |
|
$ |
(109,054 |
) |
Unrealized gain (loss) on marketable securities |
|
|
148 |
|
|
|
110 |
|
|
|
774 |
|
|
|
(1,055 |
) |
Comprehensive loss |
|
$ |
(26,962 |
) |
|
$ |
(26,591 |
) |
|
$ |
(84,530 |
) |
|
$ |
(110,109 |
) |
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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