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-EDP1815 and EDP1066 were Well Tolerated with No Overall Difference Reported from Placebo-
-Clinical Response Observed Consistent with Reductions in Cellular Histological and Blood Immune Cell Biomarkers in Psoriasis Patients at Low Dose of EDP1815-
- EDP1815 Phase 2 Initiation Planned for Early 2020-
-Positive EDP1066 Blood Immune Cell Biomarker Data in Psoriasis Patients at High Dose-
-First in Human Data Suggest that Oral Biologics that Act on Cells in the Small Intestine
Modulate Systemic Inflammation-
CAMBRIDGE, Mass., Aug. 06, 2019 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a biotechnology company developing oral biologics that act on cells in the small intestine with systemic therapeutic effects, today announced positive interim Phase 1b clinical data and provided second quarter 2019 financial results.
"Evelo is harnessing the therapeutic potential of cells in the small intestine which play a central role in governing the immune, metabolic, and nervous systems. Our platform has generated a diversified portfolio of oral biologic candidates that act on these cells to drive systemic effects relevant to the potential treatment of a broad range of diseases," said Simba Gill, Ph.D., chief executive officer of Evelo. "Today’s positive interim data show, for the first time in patients, clinical and biomarker responses that support our core scientific hypothesis and our vision of developing effective, oral, safe, and affordable medicines for people with major chronic diseases and cancer. We look forward to advancing into later stage trials and continuing to expand our clinical portfolio."
Inflammation: Interim Clinical Data Highlights and Anticipated Milestones
About the EDP1815 and EDP1066 Phase 1b clinical trials
Each of EDP1815 and EDP1066 are in ongoing signal-finding Phase 1b clinical trials in mild to moderate psoriasis and atopic dermatitis. Patients in these trials are randomized 2:1 to receive daily, oral administration of active drug, or placebo, for 28 days. The primary endpoint of these trials is safety and tolerability. Prospectively defined secondary and exploratory endpoints include clinical measures of disease, cellular histological biomarkers and blood immune cell biomarkers taken from biopsies and blood samples, respectively, at the start and end of the 28-day dosing period.
EDP1815 - positive interim Phase 1b clinical data at low dose in mild to moderate psoriasis patients
EDP1066 - positive interim Phase 1b biomarker data at high dose in mild to moderate psoriasis patients
Oncology: Clinical Studies and Anticipated Milestones
EDP1503 - Phase 1/2
EDP1503 - Phase 2a
Second Quarter 2019 Financial Results
Evelo will host a conference call and webcast to discuss these data and the second quarter financial results today at 8:30 a.m. ET. To access the call please dial 866-795-3242 (domestic) and 409-937-8909 (international) and provide the passcode 6380636. A live webcast of the call, including an accompanying slide presentation, will be available on the Investors sections of the Evelo website at www.evelobio.com. The archived webcast will be available approximately two hours after the conference call 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 preclinical studies 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 disease 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 and new formulations, the promise and potential impact of any of our monoclonal microbials or preclinical or clinical trial data, the timing of and plans to initiate clinical studies of 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; 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, 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.
Stefan Riley, 617-461-2442
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
Six Months Ended
|Research and development||$||15,464||$||10,172||$||31,141||$||17,315|
|General and administrative||5,923||5,056||11,050||8,338|
|Total operating expenses||21,387||15,228||42,191||25,653|
|Loss from operations||(21,387||)||(15,228||)||(42,191||)||(25,653||)|
|Other income (expense), net||446||82||951||7|
|Preferred stock dividends||—||(1,520||)||—||(3,937||)|
|Net loss attributable to common stockholders||$||(20,941||)||$||(16,666||)||$||(41,240||)||$||(29,583||)|
|Net loss per share - basic and diluted||$||(0.65||)||$||(0.85||)||$||(1.29||)||$||(2.50||)|
|Weighted-average common shares used in computing net loss per share - basic and diluted||32,041,401||19,626,985||31,983,558||11,818,302|
|(1) Expenses include the following amount of non-cash stock-based compensation expense:|
|Research and development||$||973||$||761||$||1,864||$||1,003|
|General and administrative||1,162||1,486||2,224||1,896|
EVELO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|June 30, 2019||
|Cash, cash equivalents and investments||$||113,473||$||147,919|
|Property and equipment, net||7,488||6,925|
|Liabilities and stockholders’ equity:|
|Accounts payable and current liabilities||$||9,889||$||9,235|
|Total stockholders’ equity||100,088||136,949|
|Total liabilities and stockholders’ equity||$||126,208||$||159,867|