Editas Medicine Announces Third Quarter 2023 Results and Business Updates
03 Novembro 2023 - 8:00AM
Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome
editing company, today reported financial results for the third
quarter 2023 and provided business updates.
“We made significant progress advancing EDIT-301 in the third
quarter, continuing to enroll and dose patients, and advancing the
program towards a BLA filing. We believe EDIT-301 has the potential
to be a clinically differentiated, one-time, durable medicine that
can provide life changing clinical benefits to patients with sickle
cell disease or beta thalassemia, specifically driving early and
robust correction of anemia and sustained increases in fetal
hemoglobin, and we look forward to sharing clinical data from RUBY
and EdiTHAL at ASH and in a Company-sponsored webinar next month,”
commented Gilmore O’Neill, M.B., M.M.Sc., President and Chief
Executive Officer, Editas Medicine. “I’m also excited to welcome
our new Chief Commercial and Strategy Officer, Caren Deardorf, to
the Editas leadership team, where she will leverage her experience
in successful product launches to build and lead Editas Medicine’s
commercial organization, strategy, and execution to support all
launch, commercialization, and lifecycle management activities of
the Company’s current and future pipeline of products.”
Recent Achievements and Outlook
Ex Vivo Hemoglobinopathies
- EDIT-301 Clinical Data Update
- The Company will share clinical data updates from the RUBY
trial for severe sickle cell disease (SCD) and the EdiTHAL trial
for transfusion-dependent beta thalassemia (TDT) in a
Company-sponsored webinar and in a poster at the American Society
of Hematology (ASH) Annual Meeting on Monday, December 11.
- EDIT-301 for Sickle Cell Disease
- The Company continues to enroll and dose patients in the RUBY
trial for SCD.
- In October, the U.S. Food and Drug Administration (FDA) granted
Regenerative Medicine Advanced Therapy (RMAT) designation to
EDIT-301 for the treatment of SCD.
- EDIT-301 for Transfusion-dependent Beta
Thalassemia
- The Company continues to enroll and dose patients in the
EdiTHAL trial for TDT.
Business Development
- In August, Editas Medicine entered into a licensing agreement
with Vor Bio, providing Vor Bio a non-exclusive Cas9 license for
the development of ex vivo Cas9 gene edited hematopoietic stem cell
(HSC) therapies for the treatment and/or prevention of
hematological malignancies. Under this agreement, Editas Medicine
received an upfront payment and is eligible for future development,
regulatory, and commercial milestone payments, as well as royalties
on medicines utilizing the related intellectual property.
Other Corporate Highlights
- LeadershipCaren Deardorf joined Editas as
Chief Commercial and Strategy OfficerMs. Deardorf brings to Editas
more than 25 years of international biotechnology leadership across
a range of companies and therapeutic areas. Most recently, Ms.
Deardorf served as the Chief Commercial Officer of Magenta
Therapeutics. Prior to Magenta, she served as the Chief Commercial
Officer of Ohana Biosciences where she was responsible for
developing a commercial strategy, including planning for the
company’s first product launch. Earlier in her career, Ms. Deardorf
held a variety of commercial roles of increasing responsibility at
Biogen, most recently serving as Vice President, Product
Development & Commercialization, leading and executing a highly
successful global launch of SPINRAZA®, a treatment for children and
adults with spinal muscular atrophy. During her tenure at Biogen,
Ms. Deardorf was instrumental in building the multiple sclerosis
(MS) franchise and helping to establish Biogen’s global leadership
through US and worldwide brand management, including leading the
brand and launch strategy for TECFIDERA® and the US and EU launches
of TYSABRI® and AVONEX®.
Third Quarter
2023 Financial Results
Cash, cash equivalents, and marketable securities as of
September 30, 2023, were $446.4 million compared to
$480.0 million as of June 30, 2023. The Company expects the
existing cash, cash equivalents and marketable securities to fund
operating expenses and capital expenditures into the third quarter
of 2025.
- For the three months ended
September 30, 2023, net loss attributable to common
stockholders was $45.0 million, or $0.55 per share, compared to net
loss of $55.7 million, or $0.81 per share, for the same period in
2022.
- Collaboration and other research and
development revenues increased to $5.3 million for the three months
ended September 30, 2023, compared to $42.0 thousand for the
same period in 2022. The increase is primarily related to an
upfront payment for the non-exclusive Cas9 license to Vor Bio in
the third quarter of 2023.
- Research and development expenses
decreased slightly by $0.8 million to $40.5 million for the three
months ended September 30, 2023, compared to $41.3 million for
the same period in 2022.
- General and administrative expenses
decreased by $1.2 million to $15.0 million for the three months
ended September 30, 2023, compared to $16.2 million for the
same period in 2022. The decrease was driven by reduced headcount
related expense, including stock compensation, and reduced legal
costs.
Upcoming Events Editas Medicine plans to
participate in the following scientific and medical conference:
- American Society of Hematology (ASH) 2023 Annual
MeetingDecember 8-12, 2023San Diego, CA
Editas Medicine plans to participate in the following investor
events:
- Truist Securities BioPharma SymposiumNovember 8-9, 2023New
York, NY
- Stifel 2023 Healthcare ConferenceNovember 14-15, 2023New York,
NY
- Evercore ISI’s Annual HealthCONx ConferenceNovember 28-30,
2023Miami, 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 third quarter 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 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, 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 December
2023, 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 EDIT-301; 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 EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Collaboration and other
research and development revenues |
$ |
5,336 |
|
|
|
42 |
|
|
$ |
18,074 |
|
|
$ |
13,176 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
40,512 |
|
|
|
41,326 |
|
|
|
108,095 |
|
|
|
122,960 |
|
General and administrative |
|
14,987 |
|
|
|
16,236 |
|
|
|
55,198 |
|
|
|
52,720 |
|
Total operating expenses |
|
55,499 |
|
|
|
57,562 |
|
|
|
163,293 |
|
|
|
175,680 |
|
Operating loss |
|
(50,163 |
) |
|
|
(57,520 |
) |
|
|
(145,219 |
) |
|
|
(162,504 |
) |
Other income, net: |
|
|
|
|
|
|
|
Other (expense) income, net |
|
— |
|
|
|
1 |
|
|
|
(1,590 |
) |
|
|
4 |
|
Interest income, net |
|
5,144 |
|
|
|
1,793 |
|
|
|
12,464 |
|
|
|
2,806 |
|
Total other income, net |
|
5,144 |
|
|
|
1,794 |
|
|
|
10,874 |
|
|
|
2,810 |
|
Net loss |
$ |
(45,019 |
) |
|
$ |
(55,726 |
) |
|
$ |
(134,345 |
) |
|
$ |
(159,694 |
) |
Net loss per share, basic and
diluted |
$ |
(0.55 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.81 |
) |
|
$ |
(2.33 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
81,648,250 |
|
|
|
68,736,125 |
|
|
|
74,029,645 |
|
|
|
68,621,574 |
|
|
EDITAS MEDICINE, INC.Selected Consolidated
Balance Sheet Items(amounts in
thousands)(Unaudited) |
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
Cash, cash equivalents, and
marketable securities |
$ |
446,414 |
|
|
$ |
437,371 |
|
Working capital |
|
300,000 |
|
|
|
296,644 |
|
Total assets |
|
504,650 |
|
|
|
514,321 |
|
Deferred revenue, net of
current portion |
|
60,667 |
|
|
|
60,667 |
|
Total stockholders'
equity |
|
360,462 |
|
|
|
360,680 |
|
Media and Investor Contact:Cristi Barnett(617)
401-0113cristi.barnett@editasmed.com
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