Editas Medicine Announces Second Quarter 2024 Results and Business Updates
07 Agosto 2024 - 6:00AM
Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage gene editing
company, today reported financial results for the second quarter
2024 and provided business updates.
“We made significant progress in all three pillars of our
strategy this quarter, particularly reni-cel as we shared a
substantial clinical update mid-year and continued to enroll and
dose at an accelerated pace. With these data, we are highly
confident reni-cel is well positioned to be a differentiated,
best-in-class product for the treatment of sickle cell disease,”
commented Gilmore O’Neill, M.B., M.M.Sc., President and Chief
Executive Officer, Editas Medicine. “I am proud of the Editas
team’s work and our advancement in the first half of 2024 as we
move closer to becoming a commercial-stage company and continue
developing clinically differentiated, transformational medicines
for people living with serious, previously untreatable
diseases.”
Recent Achievements and Outlook
Ex Vivo Hemoglobinopathies
- Reni-cel (renizgamglogene autogedtemcel, previously
EDIT-301) for Severe Sickle Cell Disease (SCD)
- On-track to present a substantive clinical data set of sickle
cell patients with considerable clinical follow-up in the RUBY
trial by year-end 2024.
- Completed enrollment of the adolescent cohort of the Phase
1/2/3 RUBY trial for SCD.
- Manufacturing drug product for the initial adolescent cohort
patients.
- The Company continues to dose adult patients in the RUBY trial.
As previously disclosed, the Company has completed enrollment of
the adult cohort.
- Reni-cel for Transfusion-dependent Beta Thalassemia
(TDT)
- On-track to present additional clinical data from the EdiTHAL
trial by year-end 2024.
- The Company completed enrollment of the adult cohort of the
EdiTHAL trial for TDT and continues to dose patients.
In Vivo Medicines
- On-track to establish in vivo preclinical proof-of-concept for
an undisclosed indication by year-end.
- The Company continues to pursue an in vivo strategy and
approach aimed at driving functional upregulation of gene
expression to address loss of function or deleterious
mutations.
Second Quarter 2024 Financial ResultsCash, cash
equivalents, and marketable securities as of June 30, 2024,
were $318.3 million compared to $376.8 million as of
March 31, 2024. 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 its license agreement with Vertex Pharmaceuticals,
Incorporated, to fund operating expenses and capital expenditures
into 2026.
Second Quarter 2024
- For the three months ended June 30, 2024, net loss attributable
to common stockholders was $67.6 million, or $0.82 per share,
compared to net loss of $40.3 million, or $0.56 per share, for
the same period in 2023.
- Collaboration and other research and
development revenues decreased to $0.5 million for the three
months ended June 30, 2024, compared to $2.9 million for the
same period in 2023. The decrease is primarily attributable to
reduced drug supply activity with collaborators.
- Research and development expenses
increased by $24.4 million to $54.2 million for the three
months ended June 30, 2024, compared to $29.8 million for the
same period in 2023. The increase is primarily related to clinical
and manufacturing costs related to the accelerated progression of
the Company's reni-cel program as well as costs attributable to in
vivo research and discovery.
- General and administrative expenses increased by
$1.0 million to $18.2 million for the three months ended
June 30, 2024, compared to $17.2 million for the same period
in 2023. The increase is primarily attributable to increased
intellectual property and patent related fees due to increased
legal activity.
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 second quarter of 2024. To access the call, please dial
1-800-343-4849 (domestic) or 1-203-518-9848 (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 gene
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 preclinical
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 presenting
additional clinical data from the RUBY and EdiTHAL trials by
year-end 2024, the 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.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference in this press
release.
EDITAS MEDICINE, INC.Consolidated
Statement of Operations(amounts in thousands,
except share and per share
data)(Unaudited) |
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Collaboration and other
research and development revenues |
$ |
513 |
|
|
$ |
2,887 |
|
|
$ |
1,649 |
|
|
$ |
12,738 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
54,210 |
|
|
|
29,779 |
|
|
|
102,997 |
|
|
|
67,583 |
|
General and administrative |
|
18,206 |
|
|
|
17,202 |
|
|
|
37,545 |
|
|
|
40,211 |
|
Total operating expenses |
|
72,416 |
|
|
|
46,981 |
|
|
|
140,542 |
|
|
|
107,794 |
|
Operating loss |
|
(71,903 |
) |
|
|
(44,094 |
) |
|
|
(138,893 |
) |
|
|
(95,056 |
) |
Other income, net: |
|
|
|
|
|
|
|
Other income (expense), net |
|
(1 |
) |
|
|
(7 |
) |
|
|
5 |
|
|
|
(1,590 |
) |
Interest income, net |
|
4,297 |
|
|
|
3,811 |
|
|
|
9,331 |
|
|
|
7,320 |
|
Total other income, net |
|
4,296 |
|
|
|
3,804 |
|
|
|
9,336 |
|
|
|
5,730 |
|
Net loss |
$ |
(67,607 |
) |
|
$ |
(40,290 |
) |
|
$ |
(129,557 |
) |
|
$ |
(89,326 |
) |
Net loss per share, basic and
diluted |
|
(0.82 |
) |
|
|
(0.56 |
) |
|
|
(1.58 |
) |
|
|
(1.27 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
82,310,368 |
|
|
|
71,376,678 |
|
|
|
82,124,603 |
|
|
|
70,157,204 |
|
EDITAS MEDICINE, INC.Selected Consolidated
Balance Sheet Items(amounts in
thousands)(Unaudited) |
|
|
|
|
|
June 30, |
|
December 31, |
|
2024 |
|
2023 |
Cash, cash equivalents, and marketable securities |
$ |
318,307 |
|
$ |
427,135 |
Working capital |
|
212,048 |
|
|
277,612 |
Total assets |
|
384,801 |
|
|
499,153 |
Deferred revenue, net of
current portion |
|
54,204 |
|
|
60,667 |
Total stockholders'
equity |
|
232,009 |
|
|
349,097 |
Media and Investor Contact:
Cristi Barnett
(617) 401-0113
cristi.barnett@editasmed.com
Editas Medicine (NASDAQ:EDIT)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
Editas Medicine (NASDAQ:EDIT)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024