Editas Medicine Announces Fourth Quarter and Full Year 2023 Results and Business Updates
28 Fevereiro 2024 - 9:00AM
Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome
editing company, today reported financial results for the fourth
quarter and full year 2023 and provided business updates.
“I am proud of our team’s execution in 2023 as we made
significant progress in our path toward becoming a commercial-stage
company. In the fourth quarter, we continued to enroll and dose
patients in our reni-cel program, sharing promising data from a
larger patient cohort, and continuing to advance towards a BLA
filing. We also created value for Editas through business
development, leveraging our strong IP portfolio via sublicenses to
other pharmaceutical and biotechnology companies developing gene
editing medicines,” commented Gilmore O’Neill, M.B., M.M.Sc.,
President and Chief Executive Officer, Editas Medicine. “We entered
2024 with great momentum and focus on developing clinically
differentiated, transformational medicines for people living with
serious, previously untreatable diseases and working toward our
long-term vision of becoming a leader in vivo programmable gene
editing medicine.”
Recent Achievements and Outlook
Ex Vivo Hemoglobinopathies
- Reni-cel (renizgamglogene autogedtemcel, previously
EDIT-301) for Severe Sickle Cell Disease (SCD)
- Alignment with the U.S. Food and Drug Administration (FDA) that
RUBY is now considered the Phase 1/2/3 trial to support a BLA
filing.
- The Company continues to enroll and dose patients in the adult
cohort of the RUBY trial.
- The Company initiated enrollment in the adolescent cohort of
the RUBY trial.
- The Company remains on-track to present a substantive clinical
data set of sickle cell patients with considerable clinical
follow-up in the RUBY trial in mid-2024 and further data by
year-end 2024.
- In December, the Company presented safety and efficacy data
from 11 patients in the RUBY trial in a Company-sponsored webinar
and in a poster at the American Society of Hematology (ASH) Annual
Meeting.
- Reni-cel for Transfusion-dependent Beta Thalassemia
(TDT)
- The Company continues to enroll and dose patients in the
EdiTHAL trial for TDT.
- The Company remains on-track to present additional clinical
data from the EdiTHAL trial in mid-2024 and further data by
year-end 2024.
- In December, the Company presented safety and efficacy data
from 6 patients in the EdiTHAL trial in a Company-sponsored webinar
and in a poster at the ASH Annual Meeting.
In Vivo Medicines
- The Company is on track to establish in vivo preclinical
proof-of-concept for an undisclosed indication by year-end.
- In 2023, Editas Medicine strengthened and focused its discovery
organization to build an in vivo gene editing pipeline.
Business Development
- In December, Editas Medicine entered into a license agreement
with Vertex Pharmaceuticals, providing Vertex a non-exclusive
license for the Company's Cas9 gene editing technology for ex vivo
gene editing medicines targeting the BCL11A gene in the fields of
sickle cell disease and beta thalassemia, including Vertex’s
CASGEVY™ (exagamglogene autotemcel). Under the terms of the
agreement, Editas Medicine received an upfront payment and is
eligible to receive an additional $50 million contingent upfront
payment as well as annual license fees, which may include certain
sales-based annual license fee increases, through 2034.
Fourth Quarter and Full Year
2023 Financial Results
Cash, cash equivalents, and marketable securities as of
December 31, 2023, were $427.1 million compared to $446.4
million as of September 30, 2023. The Company expects the
existing cash, cash equivalents, and marketable securities together
with the near-term annual license fees and the contingent upfront
payment payable under our license agreement with Vertex
Pharmaceuticals, Incorporated, to fund operating expenses and
capital expenditures into 2026.
Fourth Quarter 2023
- For the three months ended
December 31, 2023, net loss attributable to common
stockholders was $18.9 million, or $0.23 per share, compared to net
loss of $60.7 million, or $0.88 per share, for the same period in
2022.
- Collaboration and other research and
development revenues increased to $60.0 million for the three
months ended December 31, 2023, compared to $6.5 million for
the same period in 2022. The increase was primarily attributable to
payments received under our license agreement with Vertex.
- Research and development expenses
increased by $17.6 million to $69.6 million for the three months
ended December 31, 2023, compared to $52.0 million for the
same period in 2022. The increase is primarily attributable to
sublicense payments made in connection with the Vertex license
agreement offset by savings from our re-prioritization and targeted
focus on our reni-cel program.
- General and administrative expenses
decreased by $3.5 million to $14.5 million for the three months
ended December 31, 2023, compared to $18.0 million for the
same period in 2022. The decrease was primarily driven by reduced
patent and legal costs.
Full Year 2023
- For the full year 2023, net loss
attributable to common stockholders was $153.2 million, or $2.02
per share, compared to $220.4 million, or $3.21 per share, for the
same period in 2022.
- Collaboration and other research and
development revenues were $78.1 million for 2023, compared to $19.7
million for 2022. The $58.4 million increase was primarily
attributable to payments received under our license agreement with
Vertex.
- Research and development expenses
increased by $2.7 million to $177.7 million for 2023, compared to
$175.0 million for 2022. The increase is primarily attributable to
sublicense payments made in connection with the Vertex license
agreement, partially offset by decreased external expense resulting
from our strategic reprioritization and targeted focus on our
reni-cel program.
- General and administrative expenses
were $69.7 million for 2023, compared to $70.7 million for 2022.
The $1.0 million decrease relates to decreased stock compensation
expense partially offset by an increase in professional services to
support strategic initiatives and business development
activities.
Upcoming Events Editas Medicine plans to
participate in the following investor events:
- TD Cowen 44th Annual Health Care ConferenceMarch 4, 2024Boston,
MA
- Leerink Partners Global Biopharma ConferenceMarch 12, 2024Miami
Beach, FL
- Barclays 26th Annual Global Healthcare ConferenceMarch 13,
2024Miami Beach, FL
Conference Call The Editas Medicine management
team will host a conference call and webcast today at 8:00 a.m. ET
to provide and discuss a corporate update and financial results for
the fourth quarter and full year of 2023. To access the call,
please dial 1-877-407-0989 (domestic) or 1-201-389-0921
(international) and ask for the Editas Medicine earnings call. A
live webcast of the call will also be available on the Investors
section of the Editas Medicine website at www.editasmedicine.com,
and a replay will be available approximately two hours after its
completion.
About Editas MedicineAs a clinical-stage genome
editing company, Editas Medicine is focused on translating the
power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome
editing systems into a robust pipeline of treatments for people
living with serious diseases around the world. Editas Medicine aims
to discover, develop, manufacture, and commercialize
transformative, durable, precision genomic medicines for a broad
class of diseases. Editas Medicine is the exclusive licensee of
Broad Institute’s Cas12a patent estate and Broad Institute and
Harvard University’s Cas9 patent estates for human medicines. For
the latest information and scientific presentations, please visit
www.editasmedicine.com.
Forward-Looking StatementsThis press release
contains forward-looking statements and information within the
meaning of The Private Securities Litigation Reform Act of 1995.
The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’
‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’
‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’
‘‘would,’’ and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Forward-looking
statements in this press release include statements regarding the
initiation, timing, progress and results of the Company’s
preclinical and clinical studies and its research and development
programs, including establishing in vivo proof-of-concept for an
undisclosed indication by year-end 2024, the timing for the
Company’s receipt and presentation of data from its clinical trials
and preclinical studies, including clinical data updates for the
RUBY and EdiTHAL trials in mid-2024 and by year-end 2024, potential
of, and expectations for, the Company’s product candidates, the
timing or likelihood of regulatory filings and approvals, the
Company’s expectations regarding commercial readiness, and the
Company’s expectations regarding cash runway. The Company may not
actually achieve the plans, intentions, or expectations disclosed
in these forward-looking statements, and you should not place undue
reliance on these forward-looking statements. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in these forward-looking statements as a
result of various important factors, including: uncertainties
inherent in the initiation and completion of pre-clinical studies
and clinical trials, including the RUBY and EdiTHAL trials, and
clinical development of the Company’s product candidates, including
reni-cel; availability and timing of results from pre-clinical
studies and clinical trials; whether interim results from a
clinical trial will be predictive of the final results of the trial
or the results of future trials; expectations for regulatory
approvals to conduct trials or to market products and availability
of funding sufficient for the Company’s foreseeable and
unforeseeable operating expenses and capital expenditure
requirements. These and other risks are described in greater detail
under the caption “Risk Factors” included in the Company’s most
recent Annual Report on Form 10-K, which is on file with the
Securities and Exchange Commission, as updated by the Company’s
subsequent filings with the Securities and Exchange Commission, and
in other filings that the Company may make with the Securities and
Exchange Commission in the future. Any forward-looking statements
contained in this press release represent the Company’s views only
as of the date hereof and should not be relied upon as representing
its views as of any subsequent date. Except as required by law, the
Company explicitly disclaims any obligation to update any
forward-looking statements.
EDITAS MEDICINE, INC.Consolidated
Statement of Operations(amounts in thousands,
except share and per share
data)(Unaudited) |
|
|
Three Months EndedDecember
31, |
|
Twelve Months EndedDecember
31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration and other
research and development revenues |
|
60,049 |
|
|
|
6,536 |
|
|
|
78,123 |
|
|
|
19,712 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
69,556 |
|
|
|
51,998 |
|
|
|
177,651 |
|
|
|
174,958 |
|
General and administrative |
|
14,455 |
|
|
|
17,984 |
|
|
|
69,653 |
|
|
|
70,704 |
|
Total operating expenses |
|
84,011 |
|
|
|
69,982 |
|
|
|
247,304 |
|
|
|
245,662 |
|
Operating loss |
|
(23,962 |
) |
|
|
(63,446 |
) |
|
|
(169,181 |
) |
|
|
(225,950 |
) |
Other income, net: |
|
|
|
|
|
|
|
Other (expense) income, net |
|
(14 |
) |
|
|
1,289 |
|
|
|
(1,604 |
) |
|
|
1,293 |
|
Interest income, net |
|
5,102 |
|
|
|
1,419 |
|
|
|
17,566 |
|
|
|
4,225 |
|
Total other income, net |
|
5,088 |
|
|
|
2,708 |
|
|
|
15,962 |
|
|
|
5,518 |
|
Net loss |
$ |
(18,874 |
) |
|
$ |
(60,738 |
) |
|
$ |
(153,219 |
) |
|
$ |
(220,432 |
) |
Net loss per share, basic and
diluted |
$ |
(0.23 |
) |
|
$ |
(0.88 |
) |
|
$ |
(2.02 |
) |
|
$ |
(3.21 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
81,710,470 |
|
|
|
68,793,157 |
|
|
|
75,965,633 |
|
|
|
68,664,822 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EDITAS MEDICINE, INC.Selected Consolidated
Balance Sheet Items(amounts in
thousands)(Unaudited) |
|
|
December 31, |
|
December 31, |
|
|
2023 |
|
|
2022 |
Cash, cash equivalents, and
marketable securities |
$ |
427,135 |
|
$ |
437,371 |
Working capital |
|
277,612 |
|
|
296,644 |
Total assets |
|
499,153 |
|
|
514,321 |
Deferred revenue, net of
current portion |
|
60,667 |
|
|
60,667 |
Total stockholders'
equity |
|
349,097 |
|
|
360,680 |
Media and Investor Contact:
Cristi Barnett
(617) 401-0113
cristi.barnett@editasmed.com
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