–Submitted investigational new drug (IND) application for a Phase 2 trial of EDP1815 for COVID-19; data readout expected during 2H 2020–
–Selected enteric capsule formulation of EDP1815 for Phase 2 dose ranging trial in psoriasis; trial initiation now expected in 3Q 2020, with interim data in mid-2021–
–Evelo to continue enrollment in triple-negative breast cancer arm of ongoing Phase 1/2 trial of EDP1503–
–Management to host conference call at 8:30 a.m. ET–
CAMBRIDGE, Mass., May 11, 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 first quarter 2020.
“We are pleased to report that we have gathered additional clinical evidence for EDP1815 as an effective anti-inflammatory drug. In addition, based on initial clinical response data, we have decided to focus on the triple-negative breast cancer cohort for EDP1503. We also announced last week the submission of an IND for a Phase 2 study of EDP1815 for early intervention to treat COVID-19. The data readout from this trial is just one of several important catalysts for Evelo during the second half of 2020,” said Simba Gill, Ph.D., chief executive officer of Evelo. “After reviewing new clinical and biomarker data from two formulations of EDP1815, we have selected the enteric capsule formulation for evaluation in our Phase 2 psoriasis trial, which we now expect to initiate in the third quarter of 2020, with interim data expected by the middle of next year. Thanks to the nimbleness and adaptability of the team at Evelo, the Company is moving forward with executing its plans with only modest COVID-19 related delays.”
First Quarter 2020 Highlights and Recent Progress:
Phase 2 Trial in COVID-19
Biomarker Data Supporting EDP1815’s Ability to Modulate Multiple Cytokines
Additional Clinical Data with EDP1815 in an Immunopharmacology and Formulation Trial & Phase 2 Update
Evelo today announced the results of two additional clinical studies with EDP1815. Based on these data, Evelo has selected the enteric capsule formulation of EDP1815 for evaluation in its Phase 2 trial in mild to moderate psoriasis. This study will evaluate three doses of the enteric capsule formulation of EDP1815 versus placebo in approximately 225 individuals with mild to moderate psoriasis. The primary endpoint will be mean reduction in PASI score at 16 weeks.
Evelo to Focus on Triple-negative Breast Cancer (TNBC)
Upcoming Key Milestones
Given the ongoing COVID-19 pandemic and its current and anticipated impact on clinical site initiation and patient recruitment, Evelo is revising milestone guidance for EDP1815 in psoriasis and EDP1867 in atopic diseases. The company now expects to achieve the following near-term milestones across its portfolio:
First Quarter 2020 Financial Results
Evelo will host a conference call and webcast at 8:30 a.m. ET today. To access the call please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 2186056. 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 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 the development of EDP1815 for the treatment of patients with COVID-19, 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 scalability of manufacturing for EDP1815.
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: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; 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, 2020, 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|
|Operating Expenses (1):|
|Research and development||$||17,419||$||15,680|
|General and administrative||5,842||5,124|
|Total operating expenses||23,261||20,804|
|Loss from operations||(23,261||)||(20,804||)|
|Other income, net||285||505|
|Loss before income taxes||$||(22,976||)||$||(20,299||)|
|Income tax expense||(65||)||—|
|Net loss per share - basic and diluted||$||(0.71||)||$||(0.64||)|
|Weighted-average common shares used in computing net loss per share - basic and diluted||32,250,050||31,925,072|
|(1) Expenses include the following amount of non-cash stock-based compensation expense:|
|Research and development||$||1,066||$||891|
|General and administrative||889||1,062|
EVELO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|March 31, 2020||December 31, 2019|
|Cash, cash equivalents||$||58,115||$||77,833|
|Property and equipment, net||8,478||8,341|
|Right of use asset - operating lease||12,106||—|
|Liabilities and stockholders’ equity:|
|Accounts payable, accrued expenses and other||$||10,657||$||9,743|
|Operating lease liability||13,257||—|
|Total stockholders’ equity||39,344||60,197|
|Total liabilities and stockholders’ equity||$||83,147||$||90,920|