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--EDP1815 was Well Tolerated with No Overall Difference Reported from Placebo--
--Reduction in Mean Lesion Severity Score (LSS) at 28 Days Consistent between High and Low Dose Cohort--
-- Dose Response Trends Observed in LSS and PASI at Day 42--
--EDP1815 Phase 2 Study Initiation Expected in Early 2020--
--Further Clinical Support for Validation of Evelo Platform--
-- Management to Host Conference Call at 8:30 a.m. EST--
CAMBRIDGE, Mass., Nov. 05, 2019 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, today announced third quarter 2019 financial results. Additionally, in a separate press release, the Company announced positive interim clinical data in a Phase 1b trial in individuals with mild to moderate psoriasis being treated with a high dose of EDP1815, its clinical candidate for the treatment of a range of inflammatory diseases.
“We now have further clinical data that support our potential ability to treat systemic inflammatory disease through oral delivery of pharmaceuticals to the small intestinal axis,” said Simba Gill, Ph.D., chief executive officer of Evelo. “The clinical activity demonstrated by EDP1815 in psoriasis further validates our platform and highlights Evelo’s potential to bring new medicines with the potential to be effective, safe, convenient and affordable to millions of people living with chronic diseases.”
Interim Clinical Data Highlights
About the EDP1815 Phase 1b clinical trial in mild to moderate psoriasis, high dose cohort
Eighteen individuals with mild to moderate psoriasis were randomized 2:1 to receive a daily oral administration of 2.76g (5x or high dose) of EDP1815 or placebo for 28 days. The primary endpoint is safety and tolerability. Secondary and exploratory endpoints include lesion severity score (LSS) and Psoriasis Area and Severity Index (PASI), both measures of clinical activity, as well as cellular histological biomarkers and blood immune cell biomarkers taken from biopsies and blood samples at the start and end of the dosing period, respectively. Safety and tolerability and secondary clinical endpoints are also measured at day 42, 2 weeks after completion of dosing.
EDP1815 – positive interim Phase 1b clinical data at high dose
EDP1815 – Phase 1b new formulation in psoriasis and atopic dermatitis
EDP1066 – Phase 1b new formulation in atopic dermatitis
Clinical Studies and Anticipated Milestones
EDP1503 - Phase 1/2
Third Quarter 2019 Financial Results
Evelo will host a conference call and webcast at 8:30 a.m. EST today to review the new clinical data for EDP1815. To access the call please dial 866-795-3242 (domestic) or 409-937-8909 (international) and refer to conference ID 7788384. 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 Biosciences
Evelo Biosciences, Inc. is a clinical stage biotechnology company developing oral biologics that act on cells in the small intestine with systemic therapeutic effects. These cells in the small intestine play a central role in governing the immune, metabolic and neurological systems. The company’s first product candidates are monoclonal microbials, single strains of microbes selected for defined pharmacological properties. They have been observed in pre-clinical models to have systemic dose-dependent effects, modulating multiple clinically validated pathways. Evelo’s therapies have the potential to be effective, safe and affordable medicines to improve the lives of people with chronic diseases and cancer.
Evelo currently has three product candidates, EDP1066 and EDP1815 for the treatment of inflammatory diseases and EDP1503 for the treatment of cancer. Evelo is also advancing additional oral biologics 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 statements concerning our development plans, the promise and potential impact of any of our monoclonal microbials or preclinical or clinical trial data, the timing of and plans for clinical studies of EDP1815, EDP1066 and EDP1503, 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; 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 June 30, 2019, 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.
Jessica Cotrone, 978-760-5622
EVELO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands, except share and per share amounts)
Three Months Ended
Nine Months Ended
|Research and development||$||15,610||$||11,227||$||46,751||$||28,542|
|General and administrative||5,886||5,230||16,936||13,568|
|Total operating expenses||21,496||16,457||63,687||42,110|
|Loss from operations||(21,496||)||(16,457||)||(63,687||)||(42,110||)|
|Other income (expense), net||(137||)||600||814||607|
|Preferred stock dividends||—||—||—||(3,937||)|
|Net loss attributable to common stockholders||$||(21,633||)||$||(15,857||)||$||(62,873||)||$||(45,440||)|
|Net loss per share - basic and diluted||$||(0.67||)||$||(0.50||)||$||(1.96||)||$||(2.45||)|
|Weighted-average common shares used in computing net loss per share - basic and diluted||32,060,747||31,741,683||32,009,571||18,532,408|
(1) Expenses include the following amount of non-cash stock-based compensation expense:
|Research and development||$||980||$||764||$||2,844||$||1,767|
|General and administrative||1,082||831||3,306||2,727|
EVELO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|September 30, 2019||December 31, 2018|
|Cash, cash equivalents and investments||$||97,061||$||147,919|
|Property and equipment, net||8,339||6,925|
|Liabilities and stockholders’ equity:|
|Accounts payable and current liabilities||$||9,675||$||9,235|
|Total stockholders’ equity||80,546||136,949|
|Total liabilities and stockholders’ equity||$||111,140||$||159,867|