Evelo Biosciences Reports First Quarter 2021 Financial Results and Business Highlights
April 29 2021 - 7:00AM
Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage
biotechnology company developing a new modality of orally delivered
medicines, today reported financial results and business highlights
for the first quarter 2021.
“Over the past year, we have executed on our research and
development plans, providing critical preclinical and clinical data
to help inform our late-stage development plans, and further
validating our platform. We are poised to continue building on this
momentum, with multiple clinical readouts expected across our
inflammatory disease portfolio in the next 18 months, including our
Phase 2b data from EDP1815 in psoriasis in the third quarter,” said
Simba Gill, Ph.D., Chief Executive Officer of Evelo. “In order to
support this rapid growth, we continue to strengthen our corporate
position. We recently expanded our executive team with the addition
of Luca Scavo as CFO and Julie H. McHugh to our Board of Directors,
and entered into a strategic collaboration with Abdul Latif Jameel
Health to potentially provide EDP1815 to the Middle East, Turkey,
and Africa, representing a key step in realizing our vision of
providing safe, effective, convenient, and affordable medicines to
millions of people around the world.”
First Quarter 2021 Highlights and Recent
Progress
EDP1815 in Atopic Dermatitis
- In April 2021, Evelo presented full clinical data from the
Phase 1b clinical trial cohort evaluating EDP1815 for the treatment
of mild and moderate atopic dermatitis in a poster presentation at
the International Society of Atopic Dermatitis (ISAD) Hybrid
Meeting 2021. The Company previously reported positive data for all
24 patients in the cohort, which is re-iterated in the
presentation, together with new data on the Investigator Global
Assessment (IGA) score.
- The full results reinforce the data released in January 2021,
demonstrating that treatment with EDP1815 resulted in clinically
meaningful improvements in both patient- and physician-reported
outcomes.
- At the day 70 follow-up visit, 31% more EDP1815-treated
patients achieved an IGA score of 0 or 1 greater than placebo. At
this same time-point, 19% more EDP1815-treated patients reached an
IGA score of 0 or 1 with a two-point improvement from baseline
greater than placebo.
- These data, in addition to the treatment differences seen
within the Eczema Area and Severity Index (EASI), SCORing Atopic
Dermatitis (SCORAD), and IGA times Body Surface Area (IGA*BSA)
clinical endpoints, suggest the potential of EDP1815 to be a safe,
effective, well-tolerated, oral treatment for patients with mild
and moderate atopic dermatitis.
- As previously disclosed, EDP1815 was well tolerated, with no
treatment-related adverse events of moderate or severe intensity
and no serious adverse events.
EDP1815 TACTIC-E Trial in COVID-19
- The planned review of interim data after the first 90 patients
enrolled in the trial (including 30 patients treated with EDP1815)
was conducted by the Independent Data Monitoring Committee in
accordance with the protocol. No safety issues for EDP1815 were
identified. The trial has therefore proceeded with continued
recruitment. The next review of safety and efficacy data will be
after approximately 125 patients have been enrolled into the
EDP1815 arm of the trial.
Business Highlights
- In March 2021, Evelo announced a strategic collaboration with
Abdul Latif Jameel Health to develop and commercialize EDP1815 in
the Middle East, Turkey, and Africa. The collaboration leverages
Evelo’s leadership in inflammatory diseases and Abdul Latif
Jameel’s regional distribution expertise, with the goal of
accelerating the delivery of EDP1815 as an effective, affordable
medicine to people in select developing markets, many of whom
suffer significant challenges in accessing medical care. Under the
terms of the agreement, Evelo received an upfront payment and
equity investment. Evelo will be responsible for the development
and manufacturing of EDP1815, whilst Abdul Latif Jameel Health will
be responsible for regulatory submissions and commercialization
activities in the agreed-upon regions. Evelo and Abdul Latif Jameel
Health will participate in a 50:50 profit share arrangement.
- In April 2021, Evelo announced the appointments of Luca Scavo
as Chief Financial Officer and a member of the Evelo Leadership
Team, effective June 1, 2021, and Julie H. McHugh to the Board of
Directors, effective immediately.
Upcoming Key MilestonesEDP1815 – Psoriasis; all
data anticipated to be reported in 3Q 2021
- Data from Phase 1b cohorts with tablets and capsules
- Full data from Phase 2b dose-ranging trial
EDP1815 – Atopic Dermatitis
- Subject to regulatory approval, initiation of Phase 2 trial in
3Q 2021
EDP1815 – COVID-19
- While patient accrual for both COVID-19 trials continued during
the quarter, given the increase in vaccination rates, and lower
number of patients hospitalized with COVID-19 at clinical trial
sites, Evelo expects the trials will continue longer than
originally planned. The Company is unsure when it will be able to
report data, and therefore will no longer be issuing guidance
related to these trials.
EDP1867 – Atopic Dermatitis
- Interim data from Phase 1b trial expected in 4Q 2021
EDP2939 – Inflammation
- Initiation of clinical development in 2022
EDP1908 – Oncology
- Initiation of clinical development in 2022
First Quarter 2021 Financial Results
- Cash Position: As of March 31, 2021, cash and
cash equivalents were $124.6 million, as compared to cash and cash
equivalents of $68.9 million as of December 31, 2020. This increase
was primarily due to net proceeds of $82.0 million received from
the Company’s issuance of common stock, partially offset by cash
used to fund operating activities and capital expenditures in the
first quarter of 2021.
- Research and Development Expenses: R&D
expenses were $21.5 million for the three months ended March 31,
2021, compared to $17.4 million for the three months ended March
31, 2020. The increase of $4.1 million was primarily due to
increased costs related to Evelo’s inflammation clinical
development programs and personnel costs, partially offset by
decrease in R&D platform and oncology programs.
- General and Administrative Expenses: G&A
expenses were $6.0 million for the three months ended March 31,
2021, compared to $5.8 million for the three months ended March 31,
2020. The increase of $0.1 million was primarily due to increased
personnel costs and other costs.
- Net Loss: Net loss was $28.2 million for the
three months ended March 31, 2021, or $(0.55) per basic and diluted
share, as compared to a net loss of $23.0 million for the three
months ended March 31, 2020, or $(0.71) per basic and diluted
share.
Conference CallEvelo will host a conference
call and webcast at 8:30 a.m. ET today. To access the
call please dial (866) 795-3242 (domestic) or (409) 937-8909
(international) and refer to conference ID 5856668. A live webcast
of the event will also be available under “News and Events” in the
Investors section of Evelo's website at http://ir.evelobio.com. The
archived webcast will be available on Evelo's website approximately
two hours after the completion of the event and will be available
for 30 days following the call.
About Evelo BiosciencesEvelo
Biosciences is a clinical stage biotechnology company
developing orally delivered product candidates that are designed to
act on the small intestinal axis, SINTAX™, with systemic
therapeutic effects. SINTAX plays a central role in governing the
immune, metabolic, and neurological systems. The Company’s first
product candidates are pharmaceutical preparations of single
strains of microbes selected for their potential to offer defined
pharmacological properties. Evelo’s therapies have the potential to
be effective, safe, and affordable medicines to improve the lives
of people with inflammatory diseases and cancer.
Evelo currently has four product candidates in development:
EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory
diseases and EDP1908 for the treatment of cancer. Evelo is
advancing additional product candidates in other disease areas.
For more information, please
visit www.evelobio.com and engage with Evelo
on LinkedIn.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including statements concerning the development of EDP1815,
EDP1867, EDP2939, and EDP1908, the promise and potential impact of
our product candidates, the timing of and plans for clinical
trials, and the timing and results of clinical trial readouts.
These forward-looking statements are based on management's
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: the impact of the COVID-19 pandemic on our operations,
including our preclinical studies and clinical trials, and the
continuity of our business; we have incurred significant losses,
are not currently profitable and may never become profitable; our
need for additional funding; our limited operating history; our
unproven approach to therapeutic intervention; the lengthy,
expensive, and uncertain process of clinical drug development,
including potential delays in regulatory approval; our reliance on
third parties and collaborators to expand our microbial library,
conduct our clinical trials, manufacture our product candidates,
and develop and commercialize our product candidates, if approved;
our lack of experience in manufacturing, selling, marketing, and
distributing our product candidates; failure to compete
successfully against other drug companies; protection of our
proprietary technology and the confidentiality of our trade
secrets; potential lawsuits for, or claims of, infringement of
third-party intellectual property or challenges to the ownership of
our intellectual property; our patents being found invalid or
unenforceable; risks associated with international operations; our
ability to retain key personnel and to manage our growth; the
potential volatility of our common stock; our management and
principal stockholders have the ability to control or significantly
influence our business; costs and resources of operating as a
public company; unfavorable or no analyst research or reports; and
securities class action litigation against us.
These and other important factors discussed under the caption
"Risk Factors" in our Quarterly Report on Form 10-Q for the three
months ended March 31, 2021 and our other reports filed with the
SEC could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management's
estimates as of the date of this press release. While we may elect
to update such forward-looking statements at some point in the
future, except as required by law, we disclaim any obligation to do
so, even if subsequent events cause our views to change. These
forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
ContactJessica Cotrone,
978-760-5622jcotrone@evelobio.com
EVELO BIOSCIENCES,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (UNAUDITED)(in thousands, except share
and per share amounts)
|
|
Three Months EndedMarch 31, |
|
|
|
|
|
|
|
2021 |
|
2020 |
|
|
|
|
|
Operating Expenses (1): |
|
|
|
|
Research and development |
|
$ |
21,508 |
|
|
$ |
17,419 |
|
General and administrative |
|
5,963 |
|
|
5,842 |
|
Total operating expenses |
|
27,471 |
|
|
23,261 |
|
Loss from operations |
|
(27,471 |
) |
|
(23,261 |
) |
Other (expense) income,
net |
|
(603 |
) |
|
285 |
|
Loss before income taxes |
|
(28,074 |
) |
|
(22,976 |
) |
Income tax expense |
|
(122 |
) |
|
(65 |
) |
Net loss |
|
$ |
(28,196 |
) |
|
$ |
(23,041 |
) |
|
|
|
|
|
Net loss per share - basic and
diluted |
|
$ |
(0.55 |
) |
|
$ |
(0.71 |
) |
|
|
|
|
|
Weighted-average common shares
used in computing net loss per share - basic and diluted |
|
51,343,923 |
|
|
32,250,050 |
|
|
|
|
|
|
|
|
(1) Expenses include the
following amount of non-cash stock-based compensation expense. |
|
|
|
|
|
|
General and
administrative |
|
$ |
1,441 |
|
|
$ |
889 |
|
Research and development |
|
1,823 |
|
|
1,066 |
|
EVELO BIOSCIENCES,
INC.CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)(in thousands)
|
|
March 31, 2021 |
|
December 31, 2020 |
Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
124,591 |
|
|
$ |
68,857 |
|
Property and equipment,
net |
|
7,236 |
|
|
7,478 |
|
Right of use asset - operating
lease |
|
10,312 |
|
|
10,757 |
|
Other assets |
|
10,903 |
|
|
3,547 |
|
Total assets |
|
$ |
153,042 |
|
|
$ |
90,639 |
|
|
|
|
|
|
Liabilities and stockholders’
equity: |
|
|
|
|
Accounts payable, accrued
expenses and other |
|
$ |
18,719 |
|
|
$ |
19,833 |
|
Long-term debt |
|
29,258 |
|
|
30,048 |
|
Operating lease liability, net
of current portion |
|
9,463 |
|
|
9,989 |
|
Other noncurrent
liabilities |
|
7,763 |
|
|
284 |
|
Total liabilities |
|
65,203 |
|
|
60,154 |
|
Total stockholders’
equity |
|
87,839 |
|
|
30,485 |
|
Total liabilities and
stockholders’ equity |
|
$ |
153,042 |
|
|
$ |
90,639 |
|
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