-- Dosing Underway in Phase 1 Clinical Trial of EDP1066 in Psoriasis and Atopic Dermatitis --
-- IND Accepted by FDA for Phase 2a Investigator-Sponsored Clinical Trial of EDP1503 in Metastatic Melanoma --
-- Successfully Completed Initial Public Offering, Raising $85.0 Million in Gross Proceeds --
CAMBRIDGE, Mass., May 31, 2018 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company
pioneering monoclonal microbials designed to act on the gut-body network for the treatment of a wide range of diseases, today
reported financial results and provided a business update for the first quarter ended March 31, 2018.
First Quarter and Recent Business Highlights:
Pipeline:
- In May 2018, the Food and Drug Administration accepted an Investigational New Drug application to begin a 70-patient Phase 2a
clinical trial of EDP1503, a monoclonal microbial for the treatment of cancer. The University of Chicago will conduct this
investigator-sponsored open-label clinical trial, which is designed to evaluate the safety, tolerability and efficacy of EDP1503
in combination with a PD-1 inhibitor in patients with metastatic melanoma. Evelo expects the first patient to be dosed in the
second half of 2018 and to report initial clinical data in the second half of 2020. Evelo also plans to initiate a
company-sponsored trial with EDP1503 in a range of cancer types in the first half of 2019.
- In April 2018, Evelo dosed the first subject in its 96-subject Phase 1 clinical trial of EDP1066, a monoclonal microbial for
the treatment of inflammatory diseases. This clinical trial is designed to evaluate the safety and tolerability of a range
of daily doses of EDP1066 in healthy volunteers and in psoriasis and atopic dermatitis patients. Additional exploratory
endpoints to be studied in patients include the effect of EDP1066 on validated clinical measures of disease and on an integrated
set of biomarkers. Evelo expects to report initial clinical data in the first half of 2019.
- Evelo expects to initiate clinical studies of its second anti-inflammatory monoclonal microbial drug candidate, EDP1815 in
the fourth quarter of 2018.
Corporate:
- In May 2018, Evelo completed its initial public offering of common stock at $16.00 per share, raising $75.9 million in net
proceeds after deducting underwriting discounts and commissions and other estimated offering expenses.
- In February and April 2018, respectively, Evelo appointed Professor the Lord Ara Darzi of Denham and Nancy Simonian, M.D., to
its board of directors.
- In March 2018, Evelo appointed Jonathan Poole as chief financial officer.
- In February 2018, Evelo entered into a strategic, multi-year manufacturing agreement with Biose Industrie (Biose). Under the
terms of the agreement, Biose will reserve sufficient resources for the manufacture of Evelo’s drug substance over a three-year
period. In addition, the agreement with Biose gives exclusivity to Evelo for the use of Biose’s facilities for the manufacture of
orally delivered single strain microbial products.
- In February and March 2018, Evelo raised an aggregate of $81.5 million from the sale of Series C convertible preferred
stock.
- in February 2018, Evelo drew down an additional $5.0 million of debt which was available under its existing debt
facility.
First Quarter 2018 Financial Results:
- Cash Position: As of March 31, 2018, cash and cash equivalents were $114.3 million, as compared to cash and
cash equivalents of $38.2 million as of December 31, 2017. Evelo expects that its cash and cash equivalents as of March 31, 2018
together with the proceeds from its initial public offering will enable it to fund its operating expenses and capital expenditure
requirements into the second half of 2020.
- R&D Expenses: R&D expenses were $7.1 million for the three months ended March 31, 2018, as compared
to $3.8 million for the three months ended March 31, 2017. The increase of $3.3 million was due primarily to an increase of $1.6
million in costs for Evelo’s inflammation programs, driven by external preclinical research, manufacturing costs and licensing
expense, an increase of $1.3 million in gut-body network platform expenses in line with Evelo’s strategy to maximize the
potential of its platform and an increase of $0.8 million in personnel costs, including increases in salaries and bonuses of $0.5
million and an increase of $0.2 million in stock-based compensation expense. Oncology and other program expenses decreased
slightly due to the timing of activities supporting the expected start of Evelo’s clinical trial with EDP1503 in the second half
of 2018.
- G&A Expenses: G&A expenses were $3.3 million for the three months ended March 31, 2018, compared to
$1.4 million for the three months ended March 31, 2017. The increase of $1.9 million was driven by increased general and
administrative and facility needs to support Evelo’s growing R&D organization and was primarily due to an increase of $0.9
million in professional fees, including legal, patent and other professional consulting fees and an increase of $0.7 million in
personnel costs, including an increase of $0.4 million in salaries and bonus and an increase of $0.3 million in stock-based
compensation expense.
- Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $12.9 million
for the three months ended March 31, 2018, or $3.29 per basic and diluted share, as compared to a net loss attributable to common
stockholders of $6.6 million for the three months ended March 31, 2017, or $1.81 per basic and diluted share.
Upcoming Events:
- JMP Securities 2018 Life Sciences Conference: June 20-21, 2018 in New York City
About Evelo Biosciences
Evelo Biosciences is a clinical-stage company pioneering the development of a new modality of medicine designed to act on the
gut-body network – monoclonal microbials. Our monoclonal microbial product candidates are orally delivered and intended to modulate
systemic immunology and biology by acting on multiple naturally evolved biological pathways through the gut-body network. We
believe they have the potential to be broadly applicable across many diseases – including autoimmune, immunoinflammatory,
metabolic, neurological, neuroinflammatory diseases and cancer. We have observed in preclinical animal models that monoclonal
microbials neither circulate throughout the body, nor require gut colonization. These properties could present significant
potential advantages over existing therapies, including tolerability, efficacy and convenience and allow for pharmacological
intervention at all stages of disease. Evelo Biosciences was conceived and created within VentureLabs®, Flagship Pioneering’s
institutional innovation foundry, and launched by Flagship in 2015.
For more information, please visit www.evelobio.com.
Forward Looking Statements
This 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 our development plans, the promise and potential impact of any of our monoclonal microbials
or clinical trial data, timing of and plans to initiate clinical studies of EDP1503 and EDP1066 and EDP1815, the timing and results
of any clinical studies, and the sufficiency of cash to fund operations.
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: 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; a significant portion of our total outstanding shares are
eligible to be sold into the market in the near future; 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 final prospectus filed with the
Securities and Exchange Commission, or SEC, on May 9, 2018 relating to our Registration Statement on Form S-1 and our other reports
filed with the SEC, including the Quarterly Report on Form 10-Q we intend to file this week, 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, 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.
|
|
|
|
EVELO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(in thousands) |
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2018 |
|
|
|
2017 |
|
Assets |
|
|
|
Cash and cash equivalents |
$ |
114,311 |
|
|
$ |
38,246 |
|
Property and equipment, net |
|
4,429 |
|
|
|
3,496 |
|
Other assets |
|
3,573 |
|
|
|
2,046 |
|
Total assets |
$ |
122,313 |
|
|
$ |
43,788 |
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Accounts payable and current liabilities |
$ |
4,617 |
|
|
$ |
3,839 |
|
Long-term debt |
|
14,719 |
|
|
|
9,966 |
|
Other noncurrent liabilities |
|
1,724 |
|
|
|
1,004 |
|
Total liabilities |
|
21,060 |
|
|
|
14,809 |
|
|
|
|
|
Preferred stock |
|
165,778 |
|
|
|
83,702 |
|
Common stock and additional paid-in capital |
|
2,410 |
|
|
|
1,688 |
|
Accumulated Deficit |
|
(66,935 |
) |
|
|
(56,411 |
) |
Total stockholders' equity |
|
101,253 |
|
|
|
28,979 |
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
122,313 |
|
|
$ |
43,788 |
|
|
|
|
EVELO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands, except share and per share amounts) |
|
|
|
Three months ended March 31, |
|
|
2018 |
|
|
|
2017 |
|
Operating Expenses |
|
|
|
Research and Development |
$ |
7,143 |
|
|
$ |
3,846 |
|
General and Administrative |
|
3,282 |
|
|
|
1,362 |
|
Total operating expenses |
|
10,425 |
|
|
|
5,208 |
|
Loss from operations |
|
(10,425 |
) |
|
|
(5,208 |
) |
Other expenses, net |
|
(75 |
) |
|
|
(162 |
) |
Net Loss |
$ |
(10,500 |
) |
|
$ |
(5,370 |
) |
Preferred stock dividends |
|
(2,417 |
) |
|
|
(1,225 |
) |
Loss attributable to stockholders |
|
(12,917 |
) |
|
|
(6,595 |
) |
|
|
|
|
Net loss per share |
$ |
(3.29 |
) |
|
$ |
(1.81 |
) |
Shares used in computing basic and diluted net loss per share |
|
3,922,152 |
|
|
|
3,651,833 |
|
|
Contact
Evelo Biosciences
Stefan Riley
617-704-2333
stefan@evelobio.com
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