- Continued progress on '5x'25' strategy to advance five AAV
Therapeutics from REGENXBIO's internal pipeline and licensed
programs into pivotal-stage or commercial products by 2025
- Announced Updates to Eye Care Collaboration with
AbbVie
-
- Investigational gene therapy renamed ABBV-RGX-314
- IND sponsorship recently transferred to AbbVie for all
ongoing clinical trials
- Expanding sites and enrollment in ATMOSPHERE® and
ASCENT™ pivotal trials using subretinal delivery; now expected to
support U.S. and European regulatory submissions in late 2025
through the first half of 2026
- Completed enrollment in expansion cohorts in both Phase II
AAVIATE® and ALTITUDE® trials of ABBV-RGX-314
using in-office suprachoroidal delivery, expect interim trial
updates in the second half of 2023
- AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 continues to
be on track to report initial trial data in the second half of
2023
- CAMPSIITE™ clinical trial of RGX-121 for the treatment of
MPS II remains on track to file BLA in 2024 using the accelerated
approval pathway
- $474 million in cash, cash
equivalents and marketable securities as of March 31, 2023; operational runway into
2025
- Conference call Wednesday, May
3rd at 4:30 p.m.
ET
ROCKVILLE, Md., May 3, 2023
/PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced
financial results for the first quarter ended March 31, 2023, and recent operational
highlights.
"REGENXBIO is well-positioned for a transformative year, with
multiple clinical milestones and updates anticipated in 2023. Our
goal in partnering our core expertise in gene therapy with AbbVie's
leadership in eye care and their global infrastructure was to
expand and advance the reach of our retinal programs for patients
in need of a potential one-time gene therapy, and we are pleased to
progress this program with a vision of benefiting patients
worldwide. Based on the encouraging safety and clinical profiles,
we believe ABBV-RGX-314 has the potential to be a highly
differentiated product for millions of patients." said Kenneth T. Mills, President and Chief Executive
Officer of REGENXBIO. "We also continue to make tremendous strides
in our rare disease pipeline, advancing clinical trials in
Duchenne, Hunter and Hurler syndromes and Batten disease, and we
anticipate more updates across each of these programs in 2023.
Overall, with an active pipeline of clinical-stage products, we are
making excellent progress advancing our '5x'25' strategy to bring
leading, ground-breaking AAV Therapeutics to patients in
need."
AbbVie Eye Care Collaboration Update
REGENXBIO today announced updates from its eye care
collaboration with AbbVie to develop and commercialize a potential
one-time gene therapy for the treatment of chronic retinal
diseases. The updates include the transfer of the Investigational
New Drug (IND) applications to AbbVie for all ongoing clinical
trials and the expansion of the ATMOSPHERE® and
ASCENT™ pivotal trials for the treatment of patients
with wet age-related macular degeneration (wet AMD) using
subretinal delivery to support new global registration plans. As
part of the IND transfers, the investigational gene therapy RGX-314
has been renamed ABBV-RGX-314.
As outlined in the original collaboration agreement, beginning
in 2023, AbbVie has been responsible for the majority of all
development expenses for ABBV-RGX-314. The transfer of the INDs
enables AbbVie to serve as lead regulatory party in the U.S. and
globally. AbbVie will lead the clinical development and
commercialization of ABBV-RGX-314 globally. AbbVie and REGENXBIO
will continue to collaborate on additional trials of
ABBV-RGX-314.
ABBV-RGX-314 is currently being evaluated in nine ongoing
clinical trials in the U.S. and Canada, including two pivotal trials, a Phase
II bridging study, a Long-term Follow-up study, and a Fellow Eye
treatment study in patients with wet AMD, all utilizing subretinal
delivery, as well as two Phase II clinical trials in patients with
wet AMD and diabetic retinopathy (DR), and two corresponding
Long-term Follow-up studies, all utilizing in-office suprachoroidal
delivery.
The pivotal program utilizing subretinal delivery is now
expected to add new sites in Europe, Japan, and Israel to advance global development plans.
Additional clinical trial applications will be submitted to the
European Medicines Agency (EMA) and the Pharmaceuticals and Medical
Devices Agency in Japan. The
ATMOSPHERE and ASCENT trials are expected to expand enrollment to
approximately 540 and 660 patients, respectively. As prospectively
allowed in the pivotal trial protocols, the enrollment expansion is
also expected to support the increase in power of primary and
secondary endpoints to enable additional global regulatory
submissions and labelling options. The new global site plans and
expanded enrollment targets are expected to support regulatory
submissions with the U.S. Food and Drug Agency (FDA) and the EMA in
late 2025 through the first half of 2026.
Also as previously announced, under the collaboration, REGENXBIO
will continue to lead the manufacturing of ABBV-RGX-314 for
clinical development and U.S. commercial supply, and AbbVie will
lead manufacturing of ABBV-RGX-314 for commercial supply outside
the U.S. Additionally, cGMP material produced by REGENXBIO's
proprietary NAVXpress™ platform process has been incorporated into
the ongoing clinical trials, including the ATMOSPHERE and ASCENT
pivotal trials. REGENXBIO shall participate in U.S.
commercialization efforts as provided under a mutually agreed upon
commercialization plan. REGENXBIO and AbbVie will share equally in
profits from net sales of ABBV-RGX-314 in the U.S. and AbbVie will
pay REGENXBIO tiered royalties on net sales outside the U.S.
Program Highlights and Milestones
ABBV-RGX-314: ABBV-RGX-314 is an investigational one-time
AAV Therapeutic being developed in collaboration with AbbVie for
the treatment of wet AMD, DR and other additional chronic retinal
conditions. ABBV-RGX-314 uses the NAV® AAV8 vector to
deliver a gene encoding a therapeutic antibody fragment to inhibit
vascular endothelial growth factor (VEGF).
- ABBV-RGX-314 Subretinal Delivery for the Treatment of Wet
AMD
-
- Ahead of global expansion, U.S. enrollment is ongoing in
ATMOSPHERE and ASCENT. Material from REGENXBIO's NAVXpress platform
process has been incorporated in the pivotal trials and is expected
to be produced at REGENXBIO's Manufacturing Innovation Center for
future commercialization of RGX-314.
- REGENXBIO also announced today that a Fellow Eye Treatment
study has also been initiated as part of the pivotal program using
subretinal delivery. This study will evaluate the safety, efficacy,
and immunogenicity of subretinal ABBV-RGX-314 administration in the
fellow eye of patients having bilateral disease from ATMOSPHERE and
ASCENT who previously received a subretinal injection of
ABBV-RGX-314. Data from patients enrolled in this study are
expected to further support global regulatory submission
plans.
- In February 2023, interim data
was presented from the Phase II bridging study demonstrating that
ABBV-RGX-314 manufactured using REGENXBIO's NAVXpress platform
process, material from which has been incorporated into the pivotal
trials, was well tolerated and exhibited a similar clinical profile
to the initial adherent cell culture process used in the Phase
I/IIa trial. Patients in the two high dose cohorts also
demonstrated stable to improved BCVA and CRT, and meaningful
reductions in anti-VEGF burden, with a majority of subjects
injection-free. The Phase II pharmacodynamic study is designed to
evaluate the same dose levels being used in the two pivotal
trials.
- ABBV-RGX-314 Suprachoroidal Delivery for the Treatment of Wet
AMD
-
- REGENXBIO has completed enrollment of Cohort 6 in the Phase II
AAVIATE® trial. Cohort 6 (dose level 3)
incorporated short-course prophylactic ocular steroids following
ABBV-RGX-314 administration to evaluate the ability to prevent or
reduce the occurrence of the mild to moderate intraocular
inflammation seen in previous cohorts. Patients were enrolled in
Cohort 6 regardless of neutralizing antibody (NAb) status.
- REGENXBIO expects to report additional interim trial data from
the Phase II AAVIATE trial, including initial data from Cohort 6,
in the second half of 2023.
- ABBV-RGX-314 Suprachoroidal Delivery for the Treatment of
DR
-
- REGENXBIO has completed enrollment in Cohorts 4 and 5 (dose
level 3) in the Phase II ALTITUDE® trial. In these
cohorts, patients were stratified by Early Treatment Diabetic
Retinopathy Study-Diabetic Retinopathy Severity Scale (DRSS) levels
and all received short-course prophylactic ocular steroids
following ABBV-RGX-314 administration.
- REGENXBIO expects to report additional interim trial data,
including initial data from the third dose level, in the second
half of 2023.
RGX-202: RGX-202 is an investigational one-time AAV
Therapeutic for the treatment of Duchenne Muscular Dystrophy
(Duchenne), using the NAV AAV8 vector to deliver a transgene for a
novel microdystrophin that includes the functional elements of the
C-Terminal (CT) domain as well as a muscle specific promoter to
support a targeted therapy for improved resistance to muscle damage
associated with Duchenne.
- The Phase I/II AFFINITY DUCHENNE™ trial continues to recruit
patients and is expected to use commercial-scale cGMP material from
the REGENXBIO Manufacturing Innovation Center in the clinical
trial.
- In April, REGENXBIO announced the U.S. Food and Drug
Administration (FDA) granted Fast Track Designation to RGX-202 for
the treatment of Duchenne. Fast Track designation aims to
facilitate the development and expedite the review of new
therapeutics to treat serious or life-threatening conditions and
that demonstrate the potential to address unmet medical needs.
- REGENXBIO is also recruiting patients in the AFFINITY BEYOND™
trial, an observational screening study to evaluate the prevalence
of AAV8 antibodies in patients with Duchenne up to 12 years of age.
Information collected in this study may be used to identify
potential participants for the AFFINITY DUCHENNE trial and
potential future trials of RGX-202.
- REGENXBIO continues to expect to report initial data from the
Phase I/II AFFINITY DUCHENNE trial in the second half of 2023.
RGX-121: RGX-121 is an investigational one-time AAV
Therapeutic for the treatment of Mucopolysaccharidosis Type II (MPS
II), also known as Hunter Syndrome, using the NAV AAV9 vector to
deliver the gene that encodes the iduronate-2-sulfatase (I2S)
enzyme.
- The Phase I/II/III CAMPSIITE™ trial of MPS II patients aged 4
months up to 5 years is ongoing and is expected to incorporate
material from the NAVXpress platform process manufactured at the
REGENXBIO Manufacturing Innovation Center to support the future
commercialization of RGX-121.
- In February 2023, REGENXBIO
announced additional interim data from the Phase I/II part of the
CAMPSIITE trial, demonstrating that RGX-121 continued to be
well-tolerated across 15 patients. Patients receiving the pivotal
program dose level continued to demonstrate the largest reductions
in CSF GAGs, including Heparin Sulfate (HS) and HS D2S6, which
approached normal levels at 48 weeks. CSF GAGs have the potential
to be considered a surrogate biomarker that is reasonably likely to
predict clinical benefit in MPS II disease under the accelerated
approval pathway, as buildup of GAGs in the CSF of MPS II patients
correlates with clinical manifestations, including
neurodevelopmental deficits. In addition, improvements in
neurodevelopmental and daily activity skill acquisition were
observed up to three years after RGX-121 administration.
- A Phase I/II trial of RGX-121 for the treatment of pediatric
patients with MPS II over the age of five years old is also
ongoing.
- CAMPSIITE is expected to complete enrollment of 10 MPS II
patients in the first half of 2023 to support a BLA filing in 2024
using the accelerated approval pathway.
RGX-111: RGX-111 is an investigational one-time AAV
Therapeutic for the treatment of severe Mucopolysaccharidosis Type
I (MPS I), using the NAV AAV9 vector to deliver the α-l-iduronidase
(IDUA) gene.
- A Phase I/II trial of RGX-111 for the treatment of MPS I is
fully enrolled with follow-up ongoing.
- REGENXBIO has recently completed the manufacture of
commercial-scale cGMP material using the NAVXpress platform process
at the REGENXBIO Manufacturing Innovation Center to support the
continued development of RGX-111.
- In February 2023, REGENXBIO
announced additional positive interim data from the Phase I/II
trial demonstrating that RGX-111 was well tolerated in eight
patients. Biomarker and neurodevelopmental assessments indicated an
encouraging CNS profile in patients dosed with RGX-111.
- REGENXBIO expects to complete analytical characterization of
the commercial-scale cGMP material and share additional updates on
program plans in the second half of 2023.
RGX-181: RGX-181 is an investigational one-time AAV
Therapeutic for the treatment of late-infantile neuronal ceroid
lipofuscinosis type 2 (CLN2) disease, a form of Batten disease,
using the NAV AAV9 vector to deliver the TPP1 gene directly to the
central nervous system.
- Physician investigators in Brazil continue with follow up for the first
child with CLN2 disease dosed with RGX-181 under a single-patient
investigator-initiated study.
- REGENXBIO plans to provide a program update by the end of
2023.
RGX-381: RGX-381 is an investigational one-time AAV
Therapeutic for the treatment of the ocular manifestations of CLN2
disease using the NAV AAV9 vector to deliver the TPP1 gene directly
to the retina.
- The Phase I/II first-in-human, open-label, dose-escalation
clinical trial of RGX-381 is on track to initiate in the second
quarter of 2023. The trial will evaluate the safety and
tolerability, as well as the effect on retinal anatomic and
functional outcomes, of the subretinal delivery of RGX-381 for the
treatment of ocular manifestations of CLN2 disease.
Operational Updates
- The REGENXBIO Manufacturing Innovation Center in Maryland is fully operational, producing GMP
bulk substance lots to support programs using the NAVXpress™
platform process. REGENXBIO is one of only a few gene therapy
companies worldwide with a GMP facility capable of production at
scales up to 2,000 liters.
-
- In 2023, REGENXBIO continues to utilize the facility to produce
commercial-scale cGMP material for its entire clinical pipeline and
performance qualification lots to support planned regulatory
filings for ABBV-RGX-314 and RGX-121.
NAV Technology Licensee Program Highlights
As of March 31, 2023, REGENXBIO's
NAV Technology Platform was being applied in one marketed product
and multiple clinical stage partnered programs, with the potential
to impact a broad range of therapeutic areas and disease
indications.
- Zolgensma®, a one-time AAV Therapeutic for the
treatment of spinal muscular atrophy (SMA), is a marketed product
utilizing REGENXBIO's NAV AAV9 vector. In April 2023, Novartis AG reported first quarter
2023 global sales of Zolgensma of $309
million.
- In February 2023, Rocket
Pharmaceuticals (Rocket) announced that the FDA granted
Regenerative Medicine Advanced Therapy (RMAT) designation to
RP-A501, for the treatment of Danon Disease, that will provide the
benefits of added intensive FDA guidance and expedited review
through the program's development. The initiation of a Phase II
pivotal trial is on track for the second quarter of 2023. As
previously disclosed, Rocket anticipates pursuing a single arm,
open-label trial with a biomarker-based composite endpoint and a
natural history comparator. RP-A501 is being developed as a
one-time gene therapy utilizing REGENXBIO's NAV AAV9 vector.
- In February 2023, Ultragenyx
Pharmaceutical Inc. (Ultragenyx) announced that in the Phase III
study of DTX401 for Glycogen Storage Disease Type Ia (GSDIa), the
last patient has entered the baseline screening period and data
readout is expected in the first half of 2024. Ultragenyx also
randomized and dosed the first patient in the Phase III study of
DTX301 for Ornithine Transcarbamylase (OTC) Deficiency. DTX401 and
DTX301 are both being developed as one-time gene therapies
utilizing REGENXBIO's NAV AAV8 vector.
- In February 2023, uniQure N.V.
announced it expects to submit an investigational new drug
application and initiate a Phase I/II clinical study of AMT-260 to
treat temporal lobe epilepsy in the second half of 2023. AMT-260 is
being developed as a one-time gene therapy utilizing REGENXBIO's
NAV AAV9 vector.
Financial Results
Cash Position: Cash, cash equivalents and marketable
securities were $473.5 million as of
March 31, 2023, compared to
$565.2 million as of December 31, 2022. The decrease was primarily
driven by cash used to fund operating activities during the first
quarter of 2023.
Revenues: Revenues were $19.1
million for the three months ended March 31, 2023, compared to $22.2 million for the three months ended
March 31, 2022. The decrease was
primarily attributable to Zolgensma royalty revenues, which
decreased from $21.5 million in the
first quarter of 2022 to $16.1
million in the first quarter of 2023.
Research and Development Expenses: Research and
development expenses were $58.5
million for the three months ended March 31, 2023, compared to $55.6 million for the three months ended
March 31, 2022. The increase was
primarily attributable to personnel costs as a result of increased
headcount and laboratory and facilities costs, driven primarily by
the activation of the REGENXBIO Manufacturing Innovation Center in
mid-2022.
General and Administrative Expenses: General and
administrative expenses were $22.6
million for the three months ended March 31, 2023, compared to $22.3 million for the three months ended
March 31, 2022.
Net Loss: Net loss was $66.7
million, or $1.53 basic and
diluted net loss per share, for the three months ended March 31, 2023, compared to a net loss of
$76.7 million, or $1.79 basic and diluted net loss per share, for
the three months ended March 31,
2022.
Financial Guidance
REGENXBIO expects its balance in cash, cash equivalents and
marketable securities of $473.5
million as of March 31, 2023,
to fund its operations into 2025. This cash runway guidance is
based on the Company's current operational plans and excludes the
impact of any payments that may be received from AbbVie upon the
achievement of development or commercial milestones under our
ABBV-RGX-314 collaboration.
Conference Call
In connection with this announcement, REGENXBIO will host a
conference call and webcast today at 4:30
p.m. ET. Listeners can register for the webcast via this
link. Analysts wishing to participate in the question and answer
session should use this link. A replay of the webcast will be
available via the company's investor website approximately two
hours after the call's conclusion. Those who plan on participating
are advised to join 15 minutes prior to the start time.
About REGENXBIO Inc.
REGENXBIO is a leading clinical-stage biotechnology company
seeking to improve lives through the curative potential of gene
therapy. REGENXBIO's NAV Technology Platform, a proprietary
adeno-associated virus (AAV) gene delivery platform, consists of
exclusive rights to more than 100 novel AAV vectors, including
AAV7, AAV8 and AAV9. REGENXBIO and its third-party NAV Technology
Platform Licensees are applying the NAV Technology Platform in the
development of a broad pipeline of candidates, including late-stage
and commercial programs, in multiple therapeutic areas. REGENXBIO
is committed to a "5x'25" strategy to progress five AAV
Therapeutics from our internal pipeline and licensed programs into
pivotal-stage or commercial products by 2025.
Forward-Looking Statements
This press release includes "forward-looking statements," within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements express a belief, expectation or
intention and are generally accompanied by words that convey
projected future events or outcomes such as "believe," "may,"
"will," "estimate," "continue," "anticipate," "assume," "design,"
"intend," "expect," "could," "plan," "potential," "predict,"
"seek," "should," "would" or by variations of such words or by
similar expressions. The forward-looking statements include
statements relating to, among other things, REGENXBIO's future
operations, clinical trials, costs and cash flow. REGENXBIO has
based these forward-looking statements on its current expectations
and assumptions and analyses made by REGENXBIO in light of its
experience and its perception of historical trends, current
conditions and expected future developments, as well as other
factors REGENXBIO believes are appropriate under the circumstances.
However, whether actual results and developments will conform with
REGENXBIO's expectations and predictions is subject to a number of
risks and uncertainties, including the timing of enrollment,
commencement and completion and the success of clinical trials
conducted by REGENXBIO, its licensees and its partners, the timing
of commencement and completion and the success of preclinical
studies conducted by REGENXBIO and its development partners, the
timely development and launch of new products, the ability to
obtain and maintain regulatory approval of product candidates, the
ability to obtain and maintain intellectual property protection for
product candidates and technology, trends and challenges in the
business and markets in which REGENXBIO operates, the size and
growth of potential markets for product candidates and the ability
to serve those markets, the rate and degree of acceptance of
product candidates and other factors, many of which are beyond the
control of REGENXBIO. Refer to the "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of REGENXBIO's Annual Report on Form 10-K for
the year ended December 31, 2022, and
comparable "risk factors" sections of REGENXBIO's Quarterly Reports
on Form 10-Q and other filings, which have been filed with the U.S.
Securities and Exchange Commission (SEC) and are available on the
SEC's website at www.sec.gov. All of the forward-looking statements
made in this press release are expressly qualified by the
cautionary statements contained or referred to herein. The actual
results or developments anticipated may not be realized or, even if
substantially realized, they may not have the expected consequences
to or effects on REGENXBIO or its businesses or operations. Such
statements are not guarantees of future performance and actual
results or developments may differ materially from those projected
in the forward-looking statements. Readers are cautioned not to
rely too heavily on the forward-looking statements contained in
this press release. These forward-looking statements speak only as
of the date of this press release. Except as required by law,
REGENXBIO does not undertake any obligation, and specifically
declines any obligation, to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
REGENXBIO
INC.
|
CONSOLIDATED BALANCE
SHEETS
|
(unaudited)
|
(in
thousands)
|
|
|
|
March 31,
2023
|
|
|
December 31,
2022
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
70,091
|
|
|
$
|
96,952
|
|
Marketable
securities
|
|
|
261,726
|
|
|
|
267,690
|
|
Accounts
receivable
|
|
|
18,861
|
|
|
|
28,082
|
|
Prepaid
expenses
|
|
|
15,521
|
|
|
|
13,900
|
|
Other current
assets
|
|
|
23,003
|
|
|
|
9,352
|
|
Total current
assets
|
|
|
389,202
|
|
|
|
415,976
|
|
Marketable
securities
|
|
|
141,709
|
|
|
|
200,560
|
|
Accounts receivable,
net
|
|
|
1,300
|
|
|
|
1,504
|
|
Property and equipment,
net
|
|
|
141,573
|
|
|
|
141,685
|
|
Operating lease
right-of-use assets
|
|
|
63,726
|
|
|
|
65,116
|
|
Restricted
cash
|
|
|
2,030
|
|
|
|
2,030
|
|
Other assets
|
|
|
8,290
|
|
|
|
6,397
|
|
Total
assets
|
|
$
|
747,830
|
|
|
$
|
833,268
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
23,283
|
|
|
$
|
27,213
|
|
Accrued expenses and
other current liabilities
|
|
|
31,709
|
|
|
|
46,794
|
|
Deferred
revenue
|
|
|
1,311
|
|
|
|
1,829
|
|
Operating lease
liabilities
|
|
|
6,303
|
|
|
|
5,997
|
|
Liability related to
sale of future royalties
|
|
|
49,728
|
|
|
|
48,601
|
|
Total current
liabilities
|
|
|
112,334
|
|
|
|
130,434
|
|
Operating lease
liabilities
|
|
|
86,992
|
|
|
|
88,802
|
|
Liability related to
sale of future royalties
|
|
|
77,382
|
|
|
|
89,005
|
|
Other
liabilities
|
|
|
5,983
|
|
|
|
8,832
|
|
Total
liabilities
|
|
|
282,691
|
|
|
|
317,073
|
|
Stockholders'
equity
|
|
|
|
|
|
|
Preferred stock; no
shares issued and outstanding
at March 31, 2023 and December 31, 2022
|
|
|
—
|
|
|
|
—
|
|
Common stock; 43,465
and 43,299 shares issued
and outstanding at March 31, 2023 and
December 31, 2022, respectively
|
|
|
4
|
|
|
|
4
|
|
Additional paid-in
capital
|
|
|
984,986
|
|
|
|
973,145
|
|
Accumulated other
comprehensive loss
|
|
|
(11,622)
|
|
|
|
(15,401)
|
|
Accumulated
deficit
|
|
|
(508,229)
|
|
|
|
(441,553)
|
|
Total stockholders'
equity
|
|
|
465,139
|
|
|
|
516,195
|
|
Total liabilities and
stockholders' equity
|
|
$
|
747,830
|
|
|
$
|
833,268
|
|
REGENXBIO
INC.
|
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(unaudited)
|
(in thousands,
except per share data)
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2023
|
|
|
2022
|
|
Revenues
|
|
|
|
|
|
|
License and royalty
revenue
|
|
$
|
19,138
|
|
|
$
|
22,218
|
|
Total
revenues
|
|
|
19,138
|
|
|
|
22,218
|
|
Operating
Expenses
|
|
|
|
|
|
|
Cost of
revenues
|
|
|
4,112
|
|
|
|
15,717
|
|
Research and
development
|
|
|
58,516
|
|
|
|
55,627
|
|
General and
administrative
|
|
|
22,634
|
|
|
|
22,318
|
|
Other operating
expenses
|
|
|
33
|
|
|
|
83
|
|
Total operating
expenses
|
|
|
85,295
|
|
|
|
93,745
|
|
Loss from
operations
|
|
|
(66,157)
|
|
|
|
(71,527)
|
|
Other Income
(Expense)
|
|
|
|
|
|
|
Interest income from
licensing
|
|
|
70
|
|
|
|
94
|
|
Investment
income
|
|
|
2,166
|
|
|
|
799
|
|
Interest
expense
|
|
|
(2,755)
|
|
|
|
(6,130)
|
|
Total other income
(expense)
|
|
|
(519)
|
|
|
|
(5,237)
|
|
Loss before income
taxes
|
|
|
(66,676)
|
|
|
|
(76,764)
|
|
Income Tax
Benefit
|
|
|
—
|
|
|
|
41
|
|
Net loss
|
|
$
|
(66,676)
|
|
|
$
|
(76,723)
|
|
Other Comprehensive
Income (Loss)
|
|
|
|
|
|
|
Unrealized gain (loss)
on available-for-sale securities, net
|
|
|
3,779
|
|
|
|
(9,381)
|
|
Total other
comprehensive income (loss)
|
|
|
3,779
|
|
|
|
(9,381)
|
|
Comprehensive
loss
|
|
$
|
(62,897)
|
|
|
$
|
(86,104)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(1.53)
|
|
|
$
|
(1.79)
|
|
Weighted-average common
shares outstanding, basic and diluted
|
|
|
43,451
|
|
|
|
42,944
|
|
Contacts:
Dana Cormack
Corporate Communications
dcormack@regenxbio.com
Investors:
Chris Brinzey, ICR Westwicke
339-970-2843
Chris.brinzey@westwicke.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/regenxbio-reports-first-quarter-2023-financial-results-and-recent-operational-highlights-301815162.html
SOURCE REGENXBIO Inc.