-- Treated first patients in Phase 2 dose-ranging trial for EDP1815 in psoriasis --
-- Six clinical readouts in psoriasis, atopic dermatitis, COVID-19, and breast cancer expected over next 3-9 months --
--Advancing newly discovered microbial extracellular vesicles as next-generation SINTAX-based medicines--
-- Data from Phase 1b trial evaluating EDP1815 in psoriasis spotlighted today at EADV Virtual Congress --
-- Management to host conference call at 8:30 a.m. ET --
CAMBRIDGE, Mass., Oct. 29, 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 third quarter of 2020.
“We can reduce systemic inflammation in humans by oral delivery of our candidate medicines which engage SINTAX™, the small intestinal axis. We have accumulated the evidence for this from multiple cohorts of patients in two clinical trials. We are now building on these results in the next phases of development, with clinical trials across three distinct patient populations, including mid-stage studies in psoriasis and COVID-19,” said Simba Gill, Ph.D., Chief Executive Officer of Evelo. “Together with our work on EDP1503 and EDP1867, we expect to announce six clinical results over the next three to nine months. In parallel, we have a remarkable discovery from our continued investment in research - microbial extracellular vesicles are a new form of SINTAX medicines that are now in preclinical development in both inflammation and oncology. Our portfolio is making significant progress towards our goal of providing therapies to patients with chronic inflammatory diseases and cancer.”
Third Quarter 2020 Highlights and Recent Progress
Inflammation
EDP1815 in Psoriasis
EDP1815 in Atopic Dermatitis
EDP1815 in COVID-19
Business Highlights
Upcoming Key Milestones
EDP1815
EDP1867
EDP1503
EDP1908
Third Quarter 2020 Financial Results
Conference Call
Evelo will host a conference call and webcast at 8:30 a.m. ET today to review third quarter 2020 highlights. To access the call, please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 5480508. 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 is a clinical stage biotechnology company developing oral biologics that act on SINTAX™, the small intestinal axis, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic and neurological systems. The company’s first product candidates are pharmaceutical preparations of 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 inflammatory diseases and cancer.
Evelo currently has five product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19, and EDP1503 and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.
For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.
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, EDP1867, EDP2939, EDP1503 and EDP1908, the promise and potential impact of any of our product candidates, the timing of and plans for clinical trials of EDP1815, EDP1867 and EDP1503, the timing and results of any clinical trials 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: 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 June 30, 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.
Contact
Jessica Cotrone, 978-760-5622
jcotrone@evelobio.com
EVELO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands, except share and per share amounts)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||||||
Operating Expenses (1): | ||||||||||||||||||||
Research and development | $ | 14,910 | $ | 15,610 | $ | 47,503 | $ | 46,751 | ||||||||||||
General and administrative | 5,272 | 5,886 | 16,185 | 16,936 | ||||||||||||||||
Total operating expenses | 20,182 | 21,496 | 63,688 | 63,687 | ||||||||||||||||
Loss from operations | (20,182 | ) | (21,496 | ) | (63,688 | ) | (63,687 | ) | ||||||||||||
Other (expense) income, net | (674 | ) | (137 | ) | (707 | ) | 814 | |||||||||||||
Loss before income taxes | $ | (20,856 | ) | $ | (21,633 | ) | $ | (64,395 | ) | $ | (62,873 | ) | ||||||||
Income tax expense | (67 | ) | — | (221 | ) | — | ||||||||||||||
Net loss | $ | (20,923 | ) | $ | (21,633 | ) | $ | (64,616 | ) | $ | (62,873 | ) | ||||||||
Net loss per share - basic and diluted | $ | (0.45 | ) | $ | (0.67 | ) | $ | (1.74 | ) | $ | (1.96 | ) | ||||||||
Weighted-average common shares used in computing net loss per share - basic and diluted | 46,168,013 | 32,060,747 | 37,050,907 | 32,009,571 |
(1) Expenses include the following amount of non-cash stock-based compensation expense:
Research and development | $ | 1,076 | $ | 980 | $ | 3,225 | $ | 2,844 | ||||||||||||
General and administrative | 969 | 1,082 | 2,868 | 3,306 |
EVELO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(in thousands)
September 30, 2020 | December 31, 2019 | |||||||
Assets: | ||||||||
Cash, cash equivalents | $ | 81,580 | $ | 77,833 | ||||
Property and equipment, net | 7,586 | 8,341 | ||||||
Right of use asset - operating lease | 11,192 | — | ||||||
Other assets | 4,479 | 4,746 | ||||||
Total assets | $ | 104,837 | $ | 90,920 | ||||
Liabilities and stockholders’ equity: | ||||||||
Accounts payable, accrued expenses and other | $ | 11,941 | $ | 9,743 | ||||
Long-term debt | 29,924 | 19,634 | ||||||
Operating lease liability | 12,110 | — | ||||||
Other liabilities | 432 | 1,346 | ||||||
Total liabilities | 54,407 | 30,723 | ||||||
Total stockholders’ equity | 50,430 | 60,197 | ||||||
Total liabilities and stockholders’ equity | $ | 104,837 | $ | 90,920 |