Passage Bio Reports Second Quarter 2022 Financial Results and Provides Recent Business Highlights
August 04 2022 - 7:00AM
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 second quarter ended June 30, 2022 and
provided recent business highlights.
“We continue to be excited by the data emerging from our
Imagine-1 program and the promise of our investigational therapy to
potentially offer the first disease-modifying treatment for GM1
gangliosidosis. Our initial data have been met with enthusiasm from
the clinical and patient communities, and we are thrilled to have
begun recruiting patients for the final cohort in the
dose-ascending phase of the trial,” said Edgar (Chip) Cale, interim
chief executive officer of Passage Bio. “As we look towards
the rest of the year, we remain focused on delivering several
important milestones. These include reporting initial safety and
biomarker data from Cohorts 2 and 3 in Imagine-1 and sharing
initial data from a subset of Cohort 1 in our GALax-C trial for
Krabbe disease. We also look forward to dosing the first patient in
our upliFT-D trial for frontotemporal dementia. The team at Passage
is driven to fulfill our vision of developing ground-breaking
therapies that transform the lives of patients with CNS
diseases.”
Recent Highlights
- Advanced Imagine-1 clinical trial to recruitment of
patients in final cohort, Cohort 4 (early infantile, high dose), in
dose-ascending phase of study: The Independent Data
Monitoring Committee reviewed interim safety data from Cohort 3
(early infantile, low dose) and recommended advancement to Cohort
4. Patient recruitment for this cohort is underway.
- Presented encouraging longer-term clinical and
biomarker data for patients with GM1 gangliosidosis in Imagine-1
study at the American Society of Gene and Cell Therapy (ASGCT)
25th Annual Meeting: In May 2022, the
company presented new data showing continued and meaningful
developmental improvement, as assessed by study investigators and
caregivers. For the two patients in Cohort 1, safety data at 13 and
seven months showed that a low dose of PBGM01 was well tolerated
and had a favorable safety profile. Additionally, longer-term
biomarker data for beta-galactosidase enzyme activity in
cerebrospinal fluid (CSF) and serum showed functional transgene
expression.
- Received clearance of Investigational New Drug (IND)
application by the U.S. Food and Drug Administration (FDA) for a
Phase 1 clinical program for PBML04: In May 2022, the
FDA cleared the company’s IND application for PBML04 in
metachromatic leukodystrophy (MLD), a rare, pediatric, lysosomal
storage disorder. PBML04 utilizes the same next-generation
proprietary capsid as PBGM01 and PBKR03 to deliver, through
intra-cisterna magna (ICM) administration, a
functional ARSA gene into the CSF. PBML04 represents the
company’s fourth program to receive IND clearance.
- Expanded board of directors with appointment of Michael
Kamarck, Ph.D.: In July 2022, the company announced the
appointment of Michael Kamarck, Ph.D., to its board of directors
and his appointment to the Nominating and Corporate Governance
Committee. Dr. Kamarck is a seasoned biopharmaceutical
executive with over forty years of experience in discovery
research, process development and technical operations.
Anticipated Upcoming Milestones
- Present interim safety and biomarker data from Cohorts 2 (late
infantile, high dose) and 3 (early infantile, low dose) for
Imagine-1 clinical trial for GM1 in the second half of 2022.
- Present interim safety and biomarker data from subset of Cohort
1 for GALax-C clinical trial for Krabbe disease by year-end
2022.
- Dose first patient in Phase 1/2 study with PBFT02 for FTD-GRN
in mid-2022.
Second Quarter 2022 Financial Results
- Cash Position: Cash, cash equivalents and
marketable securities were $239.3 million as of June 30, 2022,
compared to $267.1 million as of March 31, 2022. The Company
expects current cash and cash equivalents to fund operations into
the second quarter of 2024.
- Research and Development (R&D)
Expenses: R&D expenses were $26.8 million for the
second quarter ended June 30, 2022, compared to $33.1 million for
the same quarter in 2021.
- General and Administrative (G&A)
Expenses: G&A expenses were $13.0 million for the
second quarter ended June 30, 2022, compared to $15.4 million for
the same quarter in 2021.
- Net Loss: Net loss was $39.5 million, or
a net loss of $0.73 per basic and diluted share, for the second
quarter ended June 30, 2022, compared to $48.4 million, or a net
loss of $0.90 per basic and diluted share, for the same quarter in
2021.
Conference Call DetailsPassage Bio will host a
conference call and webcast today at 8:30 a.m. ET. To access
the live conference call and webcast, please register here. A live
audio webcast of the event will be available on the Investors &
News section of Passage Bio’s website
at investors.passagebio.com. The archived
webcast will be available on Passage Bio's website approximately
two hours after the completion of the event and for 30 days
following the call.
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
three clinical programs in GM1 gangliosidosis, Krabbe disease and
frontotemporal dementia with several additional programs in
preclinical development. 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 initiation 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 caused by the coronavirus
pandemic; 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.
For further information, please contact:
Investors:Stuart HendersonPassage
Bio267.866.0114shenderson@passagebio.com
Media:Mike BeyerSam Brown Inc. Healthcare
Communications312.961.2502MikeBeyer@sambrown.com
|
Passage Bio, Inc.Balance
Sheets |
|
|
|
(Unaudited) |
|
|
|
(in thousands, except share data) |
|
June 30, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
91,129 |
|
|
$ |
128,965 |
|
Marketable securities |
|
|
148,121 |
|
|
|
186,808 |
|
Prepaid expenses and other current assets |
|
|
2,316 |
|
|
|
1,726 |
|
Prepaid research and development |
|
|
9,011 |
|
|
|
7,567 |
|
Total current assets |
|
|
250,577 |
|
|
|
325,066 |
|
Property and equipment,
net |
|
|
23,566 |
|
|
|
23,806 |
|
Right of use assets -
operating leases |
|
|
20,053 |
|
|
|
- |
|
Other assets |
|
|
5,220 |
|
|
|
6,204 |
|
Total assets |
|
$ |
299,416 |
|
|
$ |
355,076 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
8,211 |
|
|
$ |
9,448 |
|
Accrued expenses and other current liabilities |
|
|
15,692 |
|
|
|
20,050 |
|
Operating lease liabilities |
|
|
3,230 |
|
|
|
- |
|
Total current liabilities |
|
|
27,133 |
|
|
|
29,498 |
|
Operating lease liabilities -
noncurrent |
|
|
24,237 |
|
|
|
- |
|
Deferred rent |
|
|
- |
|
|
|
6,921 |
|
Total liabilities |
|
|
51,370 |
|
|
|
36,419 |
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value: 300,000,000 shares authorized;
54,463,235 shares issued and outstanding at June 30, 2022 and
54,244,996 shares issued and outstanding at December 31, 2021 |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
688,253 |
|
|
|
675,346 |
|
Accumulated other comprehensive income (loss) |
|
|
(1,578 |
) |
|
|
(413 |
) |
Accumulated deficit |
|
|
(438,634 |
) |
|
|
(356,281 |
) |
Total stockholders’ equity |
|
|
248,046 |
|
|
|
318,657 |
|
Total liabilities and stockholders’ equity |
|
$ |
299,416 |
|
|
$ |
355,076 |
|
|
Passage Bio, Inc.Statements of Operations
and Comprehensive Loss(Unaudited) |
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
(in thousands, except share and per share
data) |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
26,821 |
|
|
$ |
33,112 |
|
|
$ |
53,034 |
|
|
$ |
58,082 |
|
Acquired in-process research and development |
|
|
— |
|
|
|
— |
|
|
|
1,500 |
|
|
|
1,500 |
|
General and administrative |
|
|
12,991 |
|
|
|
15,422 |
|
|
|
28,090 |
|
|
|
27,886 |
|
Loss from operations |
|
|
(39,812 |
) |
|
|
(48,534 |
) |
|
|
(82,624 |
) |
|
|
(87,468 |
) |
Interest income, net |
|
|
270 |
|
|
|
99 |
|
|
|
271 |
|
|
|
151 |
|
Net loss |
|
$ |
(39,542 |
) |
|
$ |
(48,435 |
) |
|
$ |
(82,353 |
) |
|
$ |
(87,317 |
) |
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
|
$ |
(0.73 |
) |
|
$ |
(0.90 |
) |
|
$ |
(1.52 |
) |
|
$ |
(1.66 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
54,386,318 |
|
|
|
53,885,651 |
|
|
|
54,331,340 |
|
|
|
52,615,606 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(39,542 |
) |
|
$ |
(48,435 |
) |
|
$ |
(82,353 |
) |
|
$ |
(87,317 |
) |
Unrealized gain (loss) on marketable securities |
|
|
(244 |
) |
|
|
26 |
|
|
|
(1,165 |
) |
|
|
31 |
|
Comprehensive loss |
|
$ |
(39,786 |
) |
|
$ |
(48,409 |
) |
|
$ |
(83,518 |
) |
|
$ |
(87,286 |
) |
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