Achieved primary and secondary endpoints in
Phase 1 portion of LEGEND study in non-muscle invasive bladder
cancer (NIMBC); pivotal portion underway with interim data expected
mid this year
Completed a reverse merger transaction with
Forbion European Acquisition Corp (FEAC), launched as a public
company on November 1, 2023, and completed an upsized
PIPE financing
Combined transactions resulted in net proceeds of
approximately $109 million
Closed an expanded $50M debt facility with Hercules Capital in
December 2023; extends cash runway into Q2 2025
BOSTON and
MONTREAL, Jan. 29,
2024 /PRNewswire/ - enGene Holdings Inc. (Nasdaq:
ENGN) (or "enGene" or the "Company"), a clinical-stage genetic
medicines company whose non-viral lead program is in a pivotal
study for BCG-unresponsive non-muscle invasive bladder cancer
(NMIBC), today announced its financial results for the fiscal year
ended October 31, 2023 and provided a corporate update.
"During 2023, enGene made substantial progress
advancing our lead program, EG-70 (detalimogene voraplasmid), in
our ongoing pivotal-stage LEGEND study in BCG-unresponsive
non-muscle-invasive bladder cancer with carcinoma in situ. In
addition, we were pleased to build out an accomplished leadership
team and transition into a public company," said Jason Hanson, Chief Executive Officer of enGene.
"Based on the highly differentiated attributes of our non-viral DDX
genetic medicine platform, we believe that EG-70 may become a
powerful and heavily utilized therapy in the practicing
urologists's armamentarium, providing both therapeutic benefits for
patients as well as ease-of-use advantages as compared to existing
NMIBC therapeutics and those in late-stage development. We continue
to enroll patients in our pivotal study and look forward to
reporting interim clinical results in mid-2024."
Ryan Daws, Chief
Financial Officer of enGene commented: "Together with our
$50M expanded debt facility with
Hercules Capital, the financing transactions completed concurrent
with the reverse merger provide support for the ongoing LEGEND
study of EG-70 in BCG-unresponsive and BCG-naïve NMIBC patients
with Cis, BLA-enabling activities, and additional clinical
applications. The Company is in a strong financial position, with
cash on hand expected to support operations into Q2 2025, beyond
the anticipated completion of the interim EG-70 clinical data and
additional expected corporate milestones."
Recent Business Highlights:
- Public Company Launch and EG-70 Clinical Program
Progress: On November 1, 2023,
enGene Holdings Inc launched as a publicly traded company focused
on developing non-viral gene therapies based on its novel and
proprietary dually derived chitosan, or "DDX", gene delivery
platform, which allows localized delivery of multiple gene cargos
directly to mucosal tissues and other organs. The Company's lead
product candidate, EG-70, is an intravesically administered,
non-viral, polymeric nanoparticle comprising a DNA plasmid encoding
three genes designed to generate a local immune reaction in
proximity to tumors. enGene is enrolling patients in a combined
Phase 1/2 open label registrational study of EG-70, referred to as
"LEGEND" (ClinicalTrials.gov identifier NCT04752722) with interim
data expected mid-year.
- Achieved Primary and Secondary Endpoints in Phase 1 Portion
of LEGEND Study in NMIBC: The Phase 1 portion enrolled 22
BCG-unresponsive patients, exhibited an encouraging safety profile,
a 3-month complete response rate of 68% and supported dose
selection for the Phase 2 portion of the study.
- Expanded Hercules Capital Debt Facility: On December 22, 2023, enGene announced the expansion
of its existing debt facility with Hercules to up to $50 million, subject to certain milestones, with
$22.5 million advanced at closing of
which approximately $8.6 million was
applied to refinance in full the term loans outstanding under the
prior loan agreement with Hercules.
- Key Leadership Hires: enGene continued to invest in its
senior leadership and add experienced members to its Board of
Directors. On February 2, 2023,
Alex Nichols, Ph.D., joined as
President and Chief Operating Officer, on September 7, 2023, Richard Bryce, M.D. was hired as Chief Medical
Officer and on November 29, 2023,
Ryan Daws joined as Chief Financial
Officer. Additionally, on December 19,
2023, Lota Zoth, CPA, was appointed to the Company's Board
of Directors and serves as the Company's Audit Committee
Chair.
Past and Upcoming Anticipated
Milestones
- Presented clinical data from LEGEND Phase 1 trial at 24th
Annual Meeting of the Society of Urologic Oncology in November 2023.
- Announce interim readout from the pivotal Phase 2 LEGEND study
mid-2024.
Full Year 2023 Financial Results
Cash and cash equivalents, as of October 31, 2023, were $81.5 million, compared to $20.4 million as of October 31, 2022. The Company expects that its
existing cash and cash equivalents will fund operating expenses and
capital expenditures into the second quarter of 2025.
Full Year 2023
- Total operating expenses were $26.0
million for 2023, compared to $19.4
million for 2022. Research and development expenses
increased by $1.0 million, mainly due
to increasing CMC and clinical costs relating to our pivotal EG-70
study. General and administrative expenses increased by
$5.6 million, primarily driven by
share-based compensation and professional fees associated with
accounting and audit related fees.
- For the full year 2023, net loss attributable to common
shareholders was $104.7 million, or
$151.22 per share, compared to
$29.0 million, or $44.30 per share, for the same period in 2022.
The increase in net loss is mainly attributed to the increase in
other expense. In 2023, within other expense are non-cash charges
of $80.7 million arising from fair
value adjustments on our convertible debentures and related
derivative liabilities and a loss on extinguishment upon conversion
of our convertible debentures; partially offset by non-cash fair
value gain of $10.8 million from the
cancellation of Series C preferred share warrants liabilities upon
the Reverse Recapitalization on October 31,
2023.
About enGene
enGene is a clinical-stage biotechnology company
mainstreaming genetic medicines through the delivery of
therapeutics to mucosal tissues and other organs, with the goal of
creating new ways to address diseases with high clinical needs.
enGene's lead program is EG-70 for patients with non-muscle
invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who
are unresponsive or naïve to treatment with Bacillus
Calmette-Guérin (BCG) – a disease with a high clinical burden.
EG-70 is being evaluated in an ongoing Phase 2 pivotal study. EG-70
was developed using enGene's proprietary Dually Derivatized
Oligochitosan (DDX) platform, which enables penetration of mucosal
tissues and delivery of a wide range of sizes and types of cargo,
including DNA and various forms of RNA. enGene became a publicly
traded company effective November 1, 2023, upon the completion
of a business combination with Forbion European Acquisition
Corporation, a special purpose acquisition company. For more
information, visit enGene.com.
Forward-Looking Statements
Some of the statements contained in this press
release may constitute forward-looking statements within the
meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, and "forward-looking information"
within the meaning of Canadian securities laws (collectively,
"forward-looking statements"). enGene's forward-looking statements
include, but are not limited to, statements regarding enGene's
expectations, hopes, beliefs, intentions, goals, strategies,
forecasts and projections. The words "anticipate", "appear",
"approximate", "believe", "continue", "could", "estimate",
"expect", "foresee", "intend", "may", "might", "plan", "possible",
"potential", "predict", "project", "seek", "should", "would", and
similar expressions may identify forward-looking statements, but
the absence of these words does not mean that a statement is not
forward-looking. Forward-looking statements may include, for
example, statements about: the timing and anticipated results of
our current and future clinical trials, beliefs as to the potential
benefits of EG-70, and expectations as to the future financial
position of enGene, including maximum proceeds that may be
available under the Hercules facility.
Many factors, risks, uncertainties and
assumptions could cause the Company's actual results, performance
or achievements to differ materially from those expressed or
implied by the forward-looking statements, including, without
limitation, the Company's ability to recruit and retain qualified
scientific and management personnel; establish clinical trial sites
and enroll patients in its clinical trials; execute on the
Company's clinical development plans and ability to secure
regulatory approval on anticipated timelines; and other risks and
uncertainties detailed in filings with Canadian securities
regulators on SEDAR+ and with the U.S. Securities and Exchange
Commission ("SEC") on EDGAR, including those described in the "Risk
Factors" section of the Company's Annual Report on Form 10-K for
the fiscal year ended October 31,
2023 (copies of which may be obtained at
www.sedarplus.ca or www.sec.gov).
You should not place undue reliance on any
forward-looking statements, which speak only as of the date on
which they are made. enGene anticipates that subsequent events and
developments will cause enGene's assessments to change. While
enGene may elect to update these forward-looking statements at some
point in the future, enGene specifically disclaims any obligation
to do so, unless required by applicable law. Nothing in this press
release should be regarded as a representation by any person that
the forward-looking statements set forth herein will be achieved or
that any of the contemplated results of such forward-looking
statements will be achieved.
enGene Holdings Inc.
Condensed
Consolidated Statements of Operations
Information
(unaudited)
(Amounts in thousands
of USD, except share and per share data)
|
|
Year Ended October
31,
|
|
|
|
2023
|
|
|
2022
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
16,458
|
|
|
$
|
15,467
|
|
General and
administrative
|
|
|
9,602
|
|
|
|
3,960
|
|
Total operating expenses
|
|
|
26,060
|
|
|
|
19,427
|
|
Loss from
operations
|
|
|
26,060
|
|
|
|
19,427
|
|
Total other (income)
expense, net
|
|
|
73,840
|
|
|
|
5,013
|
|
Net loss before
provision for income tax
|
|
|
99,900
|
|
|
|
24,440
|
|
Provision for income tax
|
|
|
17
|
|
|
|
22
|
|
Net loss
|
|
$
|
99,917
|
|
|
$
|
24,462
|
|
Deemed dividend
attributable to redeemable convertible
preferred shareholders
|
|
|
4,822
|
|
|
|
4,562
|
|
Net loss attributable
to common shareholders, basic and
diluted
|
|
|
104,739
|
|
|
|
29,024
|
|
Weighted-average common
shares outstanding, basic and diluted
|
|
|
692,609
|
|
|
|
655,153
|
|
Net loss per share of
common shares, basic and diluted
|
|
$
|
151.22
|
|
|
$
|
44.30
|
|
|
|
|
|
|
|
|
|
|
enGene Holdings Inc.
Condensed
Consolidated Balance Sheet
Information
(unaudited)
(Amounts in thousands
of USD)
|
|
October 31,
2023
|
|
|
October 31,
2022
|
|
Cash and cash
equivalents
|
|
$
|
81,521
|
|
|
$
|
20,434
|
|
Total assets
|
|
|
86,959
|
|
|
|
23,909
|
|
Total
liabilities
|
|
|
14,473
|
|
|
|
47,405
|
|
Total liabilities,
redeemable convertible preferred shares and shareholders'
equity
|
|
|
86,959
|
|
|
|
23,909
|
|
Contact:
For media contact: media@engene.com
For investor contact: investors@engene.com
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SOURCE enGene