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—Strong 2019 marked by clinical data that validates platform—
—Lead inflammation candidate EDP1815 showed positive clinical data across two separate cohorts—
—EDP1815 Phase 2 study initiation expected in Q2 2020—
—Multiple clinical readouts across inflammation and oncology portfolio expected throughout 2020—
—Management to host conference call at 8:30 a.m. EST—
CAMBRIDGE, Mass., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, today reported financial results and business highlights for the fourth quarter and full year 2019.
“2019 was a pivotal year for Evelo. We reported positive clinical data supporting the validation of our novel platform and demonstrating that we can target SINTAX™, the small intestinal axis, to drive clinical effects in individuals with psoriasis. These data support the role of SINTAX as an important new therapeutic target with broad potential applicability,” said Simba Gill, Ph.D., chief executive officer of Evelo. “We will build on this momentum in 2020, with multiple clinical readouts planned across our inflammation and oncology portfolio. Based on the initial safety and efficacy data reported last year, we are progressing the development of EDP1815, which could benefit millions of people with mild to moderate psoriasis as well as have potential use in other inflammatory diseases. We also look forward to advancing EDP1867 into a Phase 1b trial in asthma. EDP1867 is a non-replicating monoclonal microbial product candidate for inflammatory diseases.”
EDP1815 – Phase 2 study in mild to moderate psoriasis
EDP1815 – Phase 1b new formulation in mild to moderate psoriasis
EDP1815 – Phase 1b new formulation in mild to moderate atopic dermatitis
EDP1867 – Phase 1b clinical trial in asthma
EDP1503 – Phase 1/2
Fourth Quarter and Full Year 2019 Financial Results
Evelo will host a conference call and webcast at 8:30 a.m. EST today. To access the call please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 5849487. 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 SINTAX with systemic therapeutic effects. SINTAX plays 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. 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 four product candidates: EDP1815, EDP1867, and EDP2939 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.
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, EDP1867, 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 September 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|
|Twelve Months Ended|
|Research and development||$||16,377||$||11,343||$||63,128||$||39,885|
|General and administrative||6,293||4,650||23,229||18,218|
|Total operating expenses||22,670||15,993||86,357||58,103|
|Loss from operations||(22,670||)||(15,993||)||(86,357||)||(58,103||)|
|Other income, net||261||550||1,075||1,157|
|Loss before income taxes||$||(22,409||)||$||(15,443||)||$||(85,282||)||$||(56,946||)|
|Income tax expense||(190||)||—||(190||)||—|
|Preferred stock dividends||—||—||—||(3,937||)|
|Net loss attributable to common stockholders||$||(22,599||)||$||(15,443||)||$||(85,472||)||$||(60,883||)|
|Net loss per share - basic and diluted||$||(0.70||)||$||(0.49||)||$||(2.67||)||$||(2.78||)|
|Weighted-average common shares used in computing net loss per share - basic and diluted||32,098,009||31,778,021||32,031,862||21,871,029|
(1) Expenses include the following amount of non-cash stock-based compensation expense:
|Research and development||$||804||$||741||$||3,648||$||2,508|
|General and administrative||1,211||824||4,517||3,551|
EVELO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|Cash, cash equivalents and investments||$||77,833||$||147,919|
|Property and equipment, net||8,341||6,925|
|Liabilities and stockholders’ equity:|
|Accounts payable and current liabilities||$||9,743||$||9,235|
|Total stockholders’ equity||60,197||136,949|
|Total liabilities and stockholders’ equity||$||90,920||$||159,867|
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