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-- Advancing Multiple Product Candidates into Clinical Trials with Dosing of First Patient in Phase 1 Trial of EDP1066 in Psoriasis and Atopic Dermatitis and FDA Acceptance of IND for Phase 2a Investigator-Sponsored Trial of EDP1503 in Metastatic Melanoma --
-- Entered into Research Collaboration with Harvard University to Study Gut-Body Network --
CAMBRIDGE, Mass., Aug. 02, 2018 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO) (Evelo), a clinical stage biotechnology company developing 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 second quarter ended June 30, 2018.
“Our recent accomplishments represent important progress across our business, as we entered the clinic with our first monoclonal microbial, EDP1066, and continued to advance our broad portfolio of preclinical product candidates in a range of inflammatory and oncology indications,” said Simba Gill, Ph.D., President and Chief Executive Officer of Evelo. “Looking to the second half of 2018, we are focused on advancing EDP1815 and EDP1503 into their first clinical trials in inflammatory disease and oncology, respectively, as we seek to advance our diversified portfolio of monoclonal microbials toward ten potential clinical readouts between 2019 and 2020 across different diseases and underlying biologies. We are also committed to further understanding of the gut-body network more broadly, as highlighted by our recently-signed research collaboration with world-leaders at Harvard University, which will enable us to further explore the gut’s role in modulating immune activity throughout the body.”
Second Quarter and Recent Business Highlights:
Harvard University Research Collaboration:
Upcoming Anticipated Milestones:
Second Quarter 2018 Financial Results:
About Evelo Biosciences
Evelo Biosciences, Inc. is a clinical-stage biotechnology company developing a new modality of medicine, monoclonal microbials, which are designed to act on the gut-body network. Evelo’s product candidates are orally-delivered, single strains of microbes, selected for their defined pharmacological properties. They are intended to modulate systemic immunology and biology by acting on multiple naturally evolved biological pathways through the gut-body network. Evelo believes that monoclonal microbials have the potential to be broadly applicable across many diseases including immunoinflammatory, cancer, autoimmune, metabolic, neurological and neuroinflammatory diseases.
Evelo currently has three product candidates, EDP1066 and EDP1815 for the treatment of inflammatory diseases and EDP1503 for the treatment of cancer, for which ten clinical readouts are expected during 2019 and 2020. Evelo is also advancing additional candidates through preclinical development in other disease areas.
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 preclinical or clinical trial data, timing of and plans to initiate clinical studies of EDP1503, EDP1066 and EDP1815, the timing and results of any clinical studies or readouts, 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 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, 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)
|June 30,||December 31,|
|Cash and cash equivalents||$||178,902||$||38,246|
|Property and equipment, net||5,912||3,496|
|Liabilities, preferred stock and stockholders' equity:|
|Accounts payable and current liabilities||$||7,517||$||3,839|
|Other noncurrent liabilities||970||1,004|
|Convertible preferred stock||-||83,702|
|Common stock and additional paid-in capital||247,128||1,688|
|Total stockholders' equity||165,048||(54,723||)|
|Total liabilities, preferred stock and stockholders' equity||$||188,288||$||43,788|
EVELO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands, except share and per share amounts)
Three months ended
Six months ended
|Research and Development||$||10,172||$||4,690||$||17,315||$||8,536|
|General and Administrative||5,056||1,528||8,338||2,890|
|Total operating expenses||15,228||6,218||25,653||11,426|
|Loss from operations||(15,228||)||(6,218||)||(25,653||)||(11,426||)|
|Other expenses, net||82||(143||)||7||(305||)|
|Preferred stock dividends||(1,520||)||(1,422||)||(3,937||)||(2,647||)|
|Loss attributable to shareholders||(16,666||)||(7,783||)||(29,583||)||(14,378||)|
|Net loss per share||$||(0.85||)||$||(2.09||)||$||(2.50||)||$||(3.89||)|
|Shares used in computing basic and diluted net loss per share||19,626,985||3,730,882||11,818,302||3,691,951|
(1) Expenses include the following amount of non-cash stock-based compensation expense:
|Research and development||$||761||$||123||$||1,003||$||215|
|General and administrative||1,486||145||1,869||256|