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-- First Patient Dosed in University of Chicago Phase 2a Trial of EDP1503 in Metastatic Melanoma --
-- Preclinical Studies Have Shown Non-replicating Monoclonal Microbials Maintain Activity: EDP1867 in Development --
-- Initial Clinical Data for EDP1066 in Atopic Dermatitis and Psoriasis Expected in 2Q 2019 --
-- Initial Clinical Data for EDP1815 in Atopic Dermatitis and Psoriasis Expected in 2H 2019 --
-- Management to Host Conference Call at 8:30 a.m. ET --
CAMBRIDGE, Mass., Feb. 14, 2019 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a clinical stage biotechnology company developing monoclonal microbials, a potential new modality of oral biologic medicines, today reported financial results and provided a business update for the fourth quarter and full year 2018.
"Our platform opens up the potential for effective, orally delivered, safe and cost-effective medicines for improved treatments of inflammatory diseases and cancers. In 2018, we made significant progress and advanced our first three product candidates into clinical trials across multiple inflammatory diseases and cancers," said Simba Gill, Ph.D., president and chief executive officer of Evelo. "In 2019, we expect to advance our oncology clinical trials and announce clinical data from our ongoing inflammatory disease clinical trials which may signal the potential for monoclonal microbials as a broadly applicable new modality of medicines."
2018 and Recent Business Highlights:
Non-Replicating Monoclonal Microbials
Anticipated 2019 Clinical Milestones
Fourth Quarter and Full Year 2018 Financial Results
Evelo will host a conference call and webcast today at 8:30a.m. ET. To access the call please dial (866) 795-3242 (domestic) and (409) 937-8909 (international) and provide the passcode 7986199. A live webcast of the call 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 monoclonal microbials, a potential new modality of oral biologic medicines. Evelo’s product candidates are single strains of microbes, selected for defined pharmacological properties. They are developed to activate multiple naturally evolved biological pathways by engaging immune cells that link the small intestine to the rest of the body. Evelo believes that monoclonal microbials have the potential to be broadly applicable across many immune-mediated diseases including inflammation, cancer and autoimmune 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 statements regarding our objectives and anticipated clinical milestones for 2019, 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, the timing and results of any clinical studies of EDP1503, EDP1066 and EDP1815 and the potential to develop non-replicating monoclonal microbial clinical candidates.
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 September 30, 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, 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.
|EVELO BIOSCIENCES, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|(in thousands, except share and per share amounts)|
Three Months Ended
Twelve Months Ended
|Research and development||$||11,343||$||6,076||$||39,885||$||19,957|
|General and administrative||4,650||1,991||18,218||7,574|
|Total operating expenses||15,993||8,067||58,103||27,531|
|Loss from operations||(15,993||)||(8,067||)||(58,103||)||(27,531||)|
|Other income (expense), net||550||(76||)||1,157||(516||)|
|Preferred stock dividends||—||(1,730||)||(3,937||)||(6,085||)|
|Net loss attributable to common stockholders||$||(15,443||)||$||(9,873||)||$||(60,883||)||$||(34,132||)|
|Net loss per share - basic and diluted||$||(0.49||)||$||(2.57||)||$||(2.78||)||$||(9.10||)|
|Weighted-average common shares used in computing net loss per share - basic and diluted||31,778,021||3,840,439||21,871,029||3,750,790|
|(1) Expenses include the following amount of non-cash stock-based compensation expense:|
|Research and development||$||741||$||410||$||2,508||$||849|
|General and administrative||824||226||3,551||693|
|EVELO BIOSCIENCES, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)|
|Cash, cash equivalents and investments||$||147,919||$||38,246|
|Property and equipment, net||6,925||3,496|
|Liabilities, convertible preferred stock and stockholders’ equity (deficit):|
|Accounts payable and current liabilities||$||9,235||$||3,839|
|Convertible preferred stock||—||83,702|
|Total stockholders’ equity (deficit)||136,949||(54,723||)|
|Total liabilities, preferred stock and stockholders’ equity (deficit)||$||159,867||$||43,788|