Editas Medicine Announces Second Quarter 2023 Results and Business Updates
August 02 2023 - 6:00AM
Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome
editing company, today reported financial results for the second
quarter 2023 and business updates.
“We continued making significant progress against our strategic
plan in the second quarter, specifically the advancement of our
EDIT-301 program towards a BLA filing. The promising data we shared
in June signal that 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 and
beta thalassemia long term, specifically driving early and robust
correction of anemia and sustained increases in fetal hemoglobin.
The Editas team is excited and continues driving execution towards
our goals,” 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 Financial Officer, Erick Lucera, and our new
Chief Scientific Officer, Linda Burkly, to the Editas leadership
team, where they will utilize their respective experiences to build
our in vivo pipeline, advance us towards becoming a
commercial-stage organization, and transform the lives of people
living with serious diseases.”
Recent Achievements and Outlook
Ex Vivo Hemoglobinopathies
- EDIT-301 for Sickle Cell Disease (SCD)
- Editas Medicine remains on track to dose 20 total SCD patients
in the RUBY trial by year-end.
- The Company remains on track to provide an additional RUBY
clinical update by year-end.
- In June, Editas Medicine presented positive initial clinical
safety and efficacy data from the RUBY trial in an oral
presentation at the European Hematology Association (EHA) Hybrid
Congress in Frankfurt, Germany, and in a Company-sponsored
webinar.
- EDIT-301 for Transfusion-dependent Beta Thalassemia
(TDT)
- Editas Medicine has commenced parallel dosing in the EDITHAL
trial for TDT.
- The Company remains on track to provide an additional EDITHAL
clinical update by year-end.
- In June, Editas Medicine presented positive initial clinical
safety and efficacy data from the first patient treated in the
EDITHAL trial in a Company-sponsored webinar.
Other Corporate Highlights
- LeadershipErick Lucera joined Editas as Chief
Financial OfficerMr. Lucera brings to Editas more than 30 years of
financial, operational, and investment experience in life sciences,
including driving financial decision-making and identifying and
successfully closing strategic partnerships in the biotechnology
field. Prior to joining Editas Medicine, Mr. Lucera most recently
served as Chief Financial Officer of AVEO Pharmaceuticals, where he
helped scale the company from a clinical-stage entity, through FDA
approval and commercial launch, to its acquisition by LG Chem.Linda
C. Burkly joined Editas as Chief Scientific OfficerDr. Burkly
brings to Editas more than 35 years of experience in biotechnology
as a research leader spanning the breadth of the drug discovery and
development value chain. Her experience encompasses therapeutic
areas of immunological, neurological, and rare genetic disorders.
Linda also has a track record of contributing to the foundations of
approved medicines and late-stage clinical candidates including
Trogarzo®, Tysabri®, and Dapirolizumab (Phase 3), her role ranging
across inventing therapeutic compositions, discovering novel
pathway biology and uses of therapeutic compositions, co-authoring
INDs, and leading project teams. Prior to joining Editas Medicine,
Dr. Burkly held positions of increasing responsibility over a
37-year tenure at Biogen, most recently leading
neuroscience-focused research teams as Vice President and Senior
Distinguished Investigator from 2014 to 2022.
- ManufacturingEditas Medicine continues to
advance its internal manufacturing and quality management
capabilities. The Company is increasing its clean room capacity and
is moving activities to a new Azzur facility in Devens, MA,
expected to be completed in 2024. This new facility and increased
capacity will support the scaling of the EDIT-301 program,
including manufacturing clinical supply for the RUBY and EDITHAL
trials and preparing the Company for commercial readiness.
Second Quarter 2023 Financial Results
Cash, cash equivalents, and marketable securities as of June 30,
2023, were $480.0 million compared to $401.8 million as of March
31, 2023. The Company expects 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 June 30, 2023, net loss attributable
to common stockholders was $40.3 million, or $0.56 per share,
compared to net loss of $53.5 million, or $0.78 per share, for the
same period in 2022.
- Collaboration and other research and development revenues
decreased by $3.5 million to $2.9 million for the three months
ended June 30, 2023, compared to $6.4 million for the same period
in 2022. The decrease is related to Bristol Myers Squibb’s program
opt-in in the second quarter of 2022 that did not occur in the same
period of 2023.
- Research and development expenses decreased to $29.8 million
for the three months ended June 30, 2023, compared to $43.7 million
for the same period in 2022. The $13.9 million decrease is
attributable to the Company’s strategic reprioritization, including
a targeted clinical and manufacturing focus on EDIT-301, and
reduced employee-related costs.
- General and administrative expenses remained relatively flat,
slightly increasing by $0.3 million to $17.2 million for the three
months ended June 30, 2023, from $16.9 million for the same period
in 2022.
Conference CallThe 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 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, including dosing 20 total patients by year-end in the
RUBY trial, the timing for the Company’s receipt and presentation
of data from its clinical trials and preclinical studies, including
further clinical updates for the RUBY and EDITHAL trials by
year-end, 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, 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 Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2023 |
|
2022 |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and other
research and development revenues |
|
$ |
2,887 |
|
|
$ |
6,362 |
|
|
$ |
12,738 |
|
|
$ |
13,134 |
|
Operating expenses: |
|
|
|
Research and development |
|
|
29,779 |
|
|
|
43,659 |
|
|
|
67,583 |
|
|
|
81,635 |
|
General and
administrative |
|
|
17,202 |
|
|
|
16,937 |
|
|
|
40,211 |
|
|
|
36,483 |
|
Total operating expenses |
|
|
46,981 |
|
|
|
60,596 |
|
|
|
107,794 |
|
|
|
118,118 |
|
Operating loss |
|
|
(44,094 |
) |
|
|
(54,234 |
) |
|
|
(95,056 |
) |
|
|
(104,984 |
) |
Other income, net: |
|
|
|
Other (expense) income,
net |
|
|
(7 |
) |
|
|
235 |
|
|
|
(1,590 |
) |
|
|
1 |
|
Interest income, net |
|
|
3,811 |
|
|
|
546 |
|
|
|
7,320 |
|
|
|
1,015 |
|
Total other income, net |
|
|
3,804 |
|
|
|
781 |
|
|
|
5,730 |
|
|
|
1,016 |
|
Net loss |
|
$ |
(40,290 |
) |
|
$ |
(53,453 |
) |
|
$ |
(89,326 |
) |
|
$ |
(103,968 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.56 |
) |
|
$ |
(0.78 |
) |
|
$ |
(1.27 |
) |
|
$ |
(1.52 |
) |
Weighted-average common
shares outstanding, basic and diluted |
|
71,376,678 |
|
|
68,640,858 |
|
|
70,157,204 |
|
|
68,563,348 |
|
|
EDITAS MEDICINE, INC.Selected Consolidated
Balance Sheet Items(amounts in
thousands)(Unaudited) |
|
|
June 30, |
|
December 31, |
|
2023 |
|
2022 |
|
Cash, cash equivalents, and marketable securities |
$ |
480,033 |
|
|
$ |
437,371 |
|
Working capital |
|
386,465 |
|
|
|
296,644 |
|
Total assets |
|
541,953 |
|
|
|
514,321 |
|
Deferred revenue, net of
current portion |
|
60,667 |
|
|
|
60,667 |
|
Total stockholders'
equity |
|
399,917 |
|
|
|
360,680 |
|
Media and Investor Contact:
Cristi Barnett
(617) 401-0113
cristi.barnett@editasmed.com
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