Editas Medicine Announces First Quarter 2019 Results and Update
May 07 2019 - 4:01PM
- Building on focus in oncology through
newly-formed partnership with BlueRock Therapeutics to develop
universal allogeneic cell medicines for cancer -
Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing
company, today reported business highlights and financial results
for the first quarter of 2019.
"2019 is off to a strong start with tangible progress on
multiple fronts," said Cynthia Collins, interim Chief Executive
Officer of Editas Medicine. “We expanded and accelerated our focus
in oncology through a newly formed collaboration with BlueRock
Therapeutics. We made progress towards dosing patients in the
second half with EDIT-101 for LCA10. And, we initiated IND-enabling
activities for a potentially best-in-class medicine for sickle cell
disease and beta-thalassemia. We look forward to maintaining the
momentum through the remainder of the year and beyond.”
Recent Achievements and Outlook
- Advancing universal allogeneic cell medicines for
cancer through partnership with BlueRock Therapeutics.
Editas Medicine and BlueRock Therapeutics will combine their
respective CRISPR genome editing and induced pluripotent stem cell
(iPSC) platforms to develop universal allogeneic cell medicines to
treat cancer and other serious diseases. Gene-edited, iPSC-derived,
allogeneic cell medicines represent universal, off-the-shelf
treatments that may be mass produced with superior quality, greater
scale, and lower cost than autologous or donor-derived therapies.
The Company believes that the combination will enable the high
level of multiplexed editing needed to realize the full potential
of cell medicine, particularly in solid tumors where the greatest
unmet need exists.
- EDIT-101 on track for first patient dosing in second
half of 2019. Editas Medicine and Allergan Pharmaceuticals
International Limited expect to enroll approximately 18 patients,
aged 3 years and above, in a Phase 1/2 open label, dose escalation
study to evaluate the safety, tolerability, and efficacy of
EDIT-101 as a treatment for Leber congenital amaurosis 10 (LCA10).
In April, initial data from the ongoing enLIGHTen natural history
study of LCA10 patients were presented at the Retinal Cell and Gene
Therapy Innovation Summit by Principal Investigator Eric A. Pierce,
M.D., Ph.D., Director of the Ocular Genomics Institute and William
F. Chatlos Professor of Ophthalmology at Massachusetts Eye and Ear
and Harvard Medical School.
- Initiated IND-enabling activities for a potentially
best-in-class medicine for sickle cell disease and
beta-thalassemia. Editas Medicine is developing an
experimental medicine to directly upregulate fetal hemoglobin by
editing the beta-globin locus. The Company has previously presented
data demonstrating potential advantages of its approach as compared
to indirectly upregulating fetal hemoglobin by editing the BCL11A
erythroid enhancer. Editas Medicine will present additional data
next month at the 24th Congress of the European Hematology
Association.
- Progress towards an experimental medicine for Usher
syndrome 2A (USH2A). Pre-clinical in vivo
proof-of-concept data presented at the 22nd Annual Meeting of the
American Society of Gene & Cell Therapy demonstrated
CRISPR/Cas9 gene editing of human USH2A exon 13 can rescue the
retinal phenotype and restore auditory function in mice. Based on
these data, the Company is optimizing a lead candidate to be ready
for IND-enabling studies by the end of 2019.
- Strong balance sheet to advance the business.
The Company held cash, cash equivalents, and marketable securities
of $342 million as of March 31, 2019, providing at least 24 months
of funding for operating expenses and capital expenditures.
Upcoming Events
Editas Medicine will participate in the following investor
events:
- 5th Annual SunTrust Robinson Humphrey Life Sciences Summit, May
8, New York City;
- RBC Capital Markets 2019 Global Healthcare Conference, May 21,
8:00 a.m. ET, New York City; and
- Raymond James 2019 Life Sciences and MedTech Conference, June
18-19, New York City.
Editas Medicine will participate in the following scientific and
medical conferences:
- 24th Congress of the European Hematology Association, June
13-16, Amsterdam; and
- TIDES Oligonucleotide and Peptide Therapeutics Conference, May
20-23, San Diego.
First Quarter 2019 Financial Results
Cash, cash equivalents, and marketable securities at March 31,
2019, were $342.1 million, compared to $369.0 million at December
31, 2018.
For the three months ended March 31, 2019, net loss attributable
to common stockholders was $29.2 million, or $0.60 per share,
compared to $30.9 million, or $0.67 per share, for the same period
in 2018.
- Collaboration and other research and development revenues were
$2.1 million for the three months ended March 31, 2019, compared to
$3.9 million for the same period in 2018. The $1.9 million
decrease was primarily attributable to a $1.0 million decrease in
revenue recognized pursuant to our collaboration agreement with
Juno Therapeutics, a Celgene company that is a wholly-owned
subsidiary of Celgene Corporation, and a $0.9 million decrease in
revenue recognized pursuant to our strategic alliance with Allergan
Pharmaceuticals International Limited, partially offset by $0.1
million in revenue recognized in the first quarter of 2019 pursuant
to an out-license agreement.
- Research and development expenses decreased by $5.5 million, to
$15.8 million for the three months ended March 31, 2019, from $21.3
million for the same period in 2018. The $5.5 million decrease was
primarily attributable to $5.8 million in decreased process and
platform development expenses, mostly relating to the acquisition
of certain non-capitalizable intangible assets during the first
quarter of 2018, and $0.5 million in decreased stock-based
compensation expenses, partially offset by $0.6 million in
increased other expenses including facility-related expenses and
$0.3 million in increased employee related expenses.
- General and administrative expenses increased by $3.3 million
to $17.5 million for the three months ended March 31, 2019, from
$14.2 million for the same period in 2018. The $3.3 million
increase was primarily attributable to $1.9 million in increased
stock-based compensation expenses, $2.1 million in increased
professional service expenses and $0.7 million in increased
employee related expenses, partially offset by $1.4 million in
decreased intellectual property and patent related fees.
Conference Call The Editas Medicine management
team will host a conference call and webcast today at 5:00 p.m. ET
to provide and discuss a corporate update and financial results for
the first quarter of 2019. To access the call, please dial
844-348-3801 (domestic) or 213-358-0955 (international) and provide
the passcode 8457858. A live webcast of the call will be
available on the Investors & Media section of the Editas
Medicine website at www.editasmedicine.com and a replay will be
available approximately two hours after its completion.
About Editas Medicine As a leading genome
editing company, Editas Medicine is focused on translating the
power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known
as Cas12a) 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. For the latest information and
scientific presentations, please visit
www.editasmedicine.com.
About EDIT-101 (AGN-151587) EDIT-101 is a
CRISPR-based experimental medicine under investigation for the
treatment of Leber congenital amaurosis 10 (LCA10). EDIT-101 is
administered via a subretinal injection to reach and deliver the
gene editing machinery directly to photoreceptor cells.
About Leber Congenital AmaurosisLeber
congenital amaurosis, or LCA, is a group of inherited retinal
degenerative disorders caused by mutations in at least 18 different
genes. It is the most common cause of inherited childhood
blindness, with an incidence of two to three per 100,000 live
births worldwide. Symptoms of LCA appear within the first years of
life, resulting in significant vision loss and potentially
blindness. The most common form of the disease, LCA10, is a
monogenic disorder caused by mutations in the CEP290 gene and is
the cause of disease in approximately 20‑30 percent of all LCA
patients.
About the Editas Medicine-Allergan AllianceIn
March 2017, Editas Medicine and Allergan Pharmaceuticals
International Limited (Allergan) entered a strategic alliance and
option agreement under which Allergan received exclusive access and
the option to license up to five of Editas Medicine’s genome
editing programs for ocular diseases, including EDIT-101
(AGN-151587). Under the terms of the agreement, Allergan is
responsible for development and commercialization of optioned
products, subject to Editas Medicine’s option to co-develop and
share equally in the profits and losses of two optioned products in
the United States. In August 2018, Allergan exercised its option to
develop and commercialize EDIT-101 globally for the treatment of
LCA10. Additionally, Editas Medicine exercised its option to
co-develop and share equally in the profits and losses from
EDIT-101 in the United States. Editas Medicine is also eligible to
receive development and commercial milestones, as well as royalty
payments on a per-program basis. The agreement covers a range of
first-in-class ocular programs targeting serious,
vision-threatening diseases based on Editas Medicine’s unparalleled
CRISPR genome editing platform, including CRISPR/Cas9 and
CRISPR/Cpf1 (also known as Cas12a).
Forward-Looking Statements This 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
Company’s plans with respect to the planned Phase 1/2 clinical
trial for EDIT-101 (AGN-151587), including dosing patients in the
second half of 2019. 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 factors, including: uncertainties inherent in the
initiation and completion of preclinical studies and clinical
trials and clinical development of the Company’s product
candidates; availability and timing of results from preclinical
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 speak only as of the date hereof, and the Company
expressly disclaims any obligation to update any forward-looking
statements, whether because of new information, future events or
otherwise.
|
Editas Medicine, Inc. |
Condensed Consolidated Statements of
Operations |
(unaudited) |
(amounts in thousands, except per share and
share data) |
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2019 |
|
|
2018 |
|
Collaboration and other
research and development revenues |
|
$ |
2,069 |
|
|
$ |
3,927 |
|
Operating
expenses: |
|
|
|
|
|
|
Research
and development |
|
|
15,842 |
|
|
|
21,300 |
|
General
and administrative |
|
|
17,489 |
|
|
|
14,186 |
|
Total
operating expenses |
|
|
33,331 |
|
|
|
35,486 |
|
Operating loss |
|
|
(31,262 |
) |
|
|
(31,559 |
) |
Other income, net: |
|
|
|
|
|
|
Other
(expense) income, net |
|
|
(44 |
) |
|
|
182 |
|
Interest
income, net |
|
|
2,057 |
|
|
|
438 |
|
Total
other income, net |
|
|
2,013 |
|
|
|
620 |
|
Net loss |
|
$ |
(29,249 |
) |
|
$ |
(30,939 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.60 |
) |
|
$ |
(0.67 |
) |
Weighted-average common
shares outstanding, basic and diluted |
|
|
48,838,229 |
|
|
|
45,992,008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Editas Medicine, Inc.Selected
Condensed Consolidated Balance Sheet
Items(unaudited) (amounts in
thousands) |
|
|
|
|
|
|
|
|
March 31,2019 |
|
|
December 31,2018 |
Cash, cash
equivalents, and marketable securities |
|
$ |
342,065 |
|
$ |
368,955 |
Working capital |
|
|
306,038 |
|
|
338,876 |
Total assets |
|
|
378,916 |
|
|
420,386 |
Deferred revenue, net of current portion |
|
|
105,865 |
|
|
115,614 |
Construction financing lease obligation, net of current
portion |
|
|
- |
|
|
32,417 |
Total stockholders’ equity |
|
|
217,162 |
|
|
236,162 |
Investor Contact
Mark Mullikin
(617) 401-9083
mark.mullikin@editasmed.com
Media Contact
Cristi Barnett
(617) 401-0113
cristi.barnett@editasmed.com
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