PepGen Reports First Quarter 2023 Financial Results and Recent Corporate Developments
11 5월 2023 - 8:00PM
PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company
advancing the next generation of oligonucleotide therapies with the
goal of transforming the treatment of severe neuromuscular and
neurological diseases, today reported financial results for the
first quarter ended March 31, 2023.
“PepGen has had an impressive start to 2023 and
anticipates a meaningful year ahead. This progress builds upon the
positive results we reported in Q4 2022 from our Phase 1 Healthy
Volunteer (HV) clinical trial of PGN-EDO51, which exhibited the
highest levels of oligonucleotide delivery and exon skipping in a
clinical study following a single dose,” said James McArthur,
Ph.D., President and CEO of PepGen. “Looking ahead, we anticipate
initiating CONNECT1-EDO51, a Phase 2 study in Canada in the first
half of 2023, which we expect will allow us to report dystrophin
production, exon skipping and safety data following 4 monthly doses
of PGN-EDO51 in 2024.”
Dr. McArthur continued, “We also remain focused
on the balance of our Enhanced Delivery Oligonucleotide (EDO)
portfolio of candidate therapeutics. Based on the encouraging
non-clinical data from PGN-EDODM1, we anticipate initiating the
Phase 1 FREEDOM-DM1 study in myotonic dystrophy type 1 (DM1)
patients in the first half of 2023. We look forward to continuing
to advance our potentially transformative therapeutics to address
areas of great unmet need.”
Recent Corporate Highlights
- In March 2023, PepGen gave two oral
presentations and presented a poster updating the community on the
PGN-EDO51 and PGN-EDODM1 programs and shared previously reported
positive PGN-EDO51 Phase 1 clinical data at the 2023 Muscular
Dystrophy Association Clinical & Scientific Conference.
- In April 2023, PepGen gave an oral
and poster presentation on the preclinical data supporting the
development and advancement of PGN-EDODM1 into clinical studies,
the design of the proposed Phase 1 clinical trial, FREEDOM-DM1, and
preclinical and Phase 1 PGN-EDO51 data at the American Academy of
Neurology 2023 Annual Meeting.
Anticipated Upcoming
Milestones
- PGN-EDO51: PepGen
anticipates initiating CONNECT1-EDO51; an open-label, multiple
ascending dose (MAD) Phase 2 study in Canada in the first half of
2023 and CONNECT2-EDO51; a Phase 2 multinational, randomized,
double-blind, placebo-controlled MAD study (RCT) in the second half
of 2023 in boys and young men living with DMD. Learnings from the
open-label study will inform the global RCT, which is designed to
support a potential accelerated or conditional approval pathway
pending alignment with regulatory authorities.
- PGN-EDODM1: PepGen
anticipates initiating, FREEDOM-DM1, a randomized, double-blind,
placebo-controlled, single ascending dose (SAD) Phase 1 Study in
people living with DM1 in the first half of 2023.
Financial Results for the Three Months
Ended March 31, 2023
- Cash and cash
equivalents were $165.4 million as of March 31, 2023,
which is anticipated to fund currently planned operations into
early 2025.
- Research and
Development expenses were $14.4 million
for the three months ended March 31, 2023, compared to $10.7
million for the same period in 2022.
- General and
Administrative expenses were $3.7 million
for the three months ended March 31, 2023, compared to $3.2 million
for the same period in 2022.
- Net loss was $16.3
million for the three months ended March 31, 2023, compared to
$18.2 million for the same period in 2022. PepGen had approximately
23.8 million shares outstanding on March 31, 2023.
About PepGen
PepGen Inc. is a clinical-stage biotechnology
company advancing the next-generation of oligonucleotide therapies
with the goal of transforming the treatment of severe neuromuscular
and neurological diseases. PepGen’s Enhanced Delivery
Oligonucleotide, or EDO, platform is founded on over a decade of
research and development and leverages cell-penetrating peptides to
improve the uptake and activity of conjugated oligonucleotide
therapeutics. Using these EDO peptides, we are generating a
pipeline of oligonucleotide therapeutic candidates that are
designed to target the root cause of serious diseases.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended. These statements may be identified
by words such as “aims,” “anticipates,” “believes,” “could,”
“estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,”
“plans,” “possible,” “potential,” “seeks,” “will,” and variations
of these words or similar expressions that are intended to identify
forward-looking statements. Any such statements in this press
release that are not statements of historical fact may be deemed to
be forward-looking statements. These forward-looking statements
include, without limitation, statements regarding the potential
therapeutic benefits and safety profile of our candidates,
initiation and timeline of the Phase 2 studies in PGN-EDO51 and the
Phase 1 study in PGN-EDODM1, our interpretation of clinical and
preclinical study results and how they may impact our programs, the
status of regulatory communications and applications for PGN-EDO51
and PGN-EDODM1, statements about accelerated or conditional
approval pathway and statements about our clinical and preclinical
programs, product candidates, expected cash runway, achievement of
milestones, and corporate and clinical/preclinical strategies.
Any forward-looking statements in this press
release are based on current expectations, estimates and
projections only as of the date of this release and are subject to
a number of risks and uncertainties that could cause actual results
to differ materially and adversely from those set forth in or
implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to that we may
experience delays or fail to successfully initiate or complete our
planned clinical trials for PGN-EDO51 and PGN-EDODM1 and
preclinical studies of other product candidates or to obtain
regulatory approval before commercialization for marketing of such
products; our interpretation of clinical and preclinical study
results may be incorrect; our product candidates may not be safe
and effective; there may be delays in regulatory review, clearance
to proceed or approval or changes in regulatory framework that are
out of our control; we may not be able to nominate new drug
candidates within the estimated timeframes; our estimation of
addressable markets of our product candidates may be inaccurate; we
may need additional funding before the end of our expected cash
runway and may fail to timely raise such additional required
funding; more efficient competitors or more effective competing
treatments may emerge; we may be involved in disputes surrounding
the use of our intellectual property crucial to our success; we may
not be able to take advantage of certain accelerated regulatory
pathways; we may not be able to attract and retain key employees
and qualified personnel; earlier study results may not be
predictive of later stage study outcomes; we may encounter
liquidity distress due to failure of financial institutions with
which we maintain relationship; disruption in financial markets may
interfere with our access to cash, including our cash deposited in
financial institutions, and we are dependent on third parties for
some or all aspects of our product manufacturing, research and
preclinical and clinical testing. Additional risks concerning
PepGen’s programs and operations are described in our most recent
annual report on Form 10-K on file with the SEC and quarterly
report on Form 10-Q to be filed with the SEC. PepGen explicitly
disclaims any obligation to update any forward-looking statements
except to the extent required by law.
Investor Contact
Laurence WattsGilmartin GroupLaurence@gilmartinir.com
Media Contact
Sarah SuttonArgot Partnerspepgen@argotpartners.com
Condensed Consolidated Statements of
Operations(unaudited, in thousands except share and per
share amounts)
|
|
Three Months EndedMarch 31, |
|
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
14,360 |
|
|
$ |
10,707 |
|
General and administrative |
|
|
3,671 |
|
|
|
3,186 |
|
Total operating expenses |
|
$ |
18,031 |
|
|
$ |
13,893 |
|
Operating loss |
|
$ |
(18,031 |
) |
|
$ |
(13,893 |
) |
Other income (expense) |
|
|
|
|
|
|
Interest income |
|
|
1,792 |
|
|
9 |
|
Other income (expense), net |
|
|
(80 |
) |
|
58 |
|
Total other income (expense), net |
|
$ |
1,712 |
|
|
$ |
67 |
|
Net loss before income tax |
|
$ |
(16,319 |
) |
|
$ |
(13,826 |
) |
Income tax expense |
|
|
— |
|
|
|
(4,420 |
) |
Net loss |
|
$ |
(16,319 |
) |
|
$ |
(18,246 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.69 |
) |
|
$ |
(18.94 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
23,761,915 |
|
|
|
963,588 |
|
|
Condensed Consolidated Balance
Sheets(in thousands)
|
|
March
31,2023(unaudited) |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
165,403 |
|
|
$ |
181,752 |
|
Prepaid expenses and other current assets |
|
|
3,067 |
|
|
|
4,331 |
|
Total current assets |
|
$ |
168,470 |
|
|
$ |
186,083 |
|
Property and equipment,
net |
|
$ |
5,339 |
|
|
$ |
3,335 |
|
Operating lease right-of-use
asset |
|
|
25,759 |
|
|
|
26,549 |
|
Other assets |
|
|
1,473 |
|
|
|
1,473 |
|
Total assets |
|
$ |
201,041 |
|
|
$ |
217,440 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,472 |
|
|
$ |
1,362 |
|
Accrued expenses |
|
|
12,900 |
|
|
|
11,913 |
|
Operating lease liability |
|
|
3,655 |
|
|
|
5,553 |
|
Total current liabilities |
|
$ |
18,027 |
|
|
$ |
18,828 |
|
Operating lease liability, net of current portion |
|
|
18,171 |
|
|
|
18,981 |
|
Total liabilities |
|
$ |
36,198 |
|
|
$ |
37,809 |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred Stock |
|
$ |
— |
|
|
$ |
— |
|
Common stock |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
284,044 |
|
|
|
282,566 |
|
Accumulated other comprehensive (loss) |
|
|
(28 |
) |
|
|
(81 |
) |
Accumulated deficit |
|
|
(119,175 |
) |
|
|
(102,856 |
) |
Total stockholders’ equity |
|
$ |
164,843 |
|
|
$ |
179,631 |
|
Total liabilities and
stockholders’ equity |
|
$ |
201,041 |
|
|
$ |
217,440 |
|
PepGen (NASDAQ:PEPG)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
PepGen (NASDAQ:PEPG)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024