On October 29, 2020 Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, reported financial results and business highlights for the third quarter of 2020 (Press release, Evelo Biosciences, OCT 29, 2020, View Source [SID1234569328]).

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"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

Today, Evelo presented data from the Phase 1b clinical trial cohorts evaluating EDP1815 for the treatment of mild to moderate psoriasis at the European Academy of Dermatology and Venereology (EADV) Virtual Congress. The poster, as well as a prerecorded presentation, are now available online on the EADV conference website. The poster was selected as one of EADV’s key stories and highlighted at a virtual press conference at the event. Also at EADV, Evelo presented preclinical data, highlighting the potent anti-inflammatory effects of EDP1815 in murine models of TH1-, TH2- and TH17-mediated inflammation, including a model of chronic nervous system inflammation.
In October, Evelo dosed the first patients in the Phase 2 dose-ranging trial evaluating EDP1815 for the treatment of mild to moderate psoriasis. The trial is evaluating three doses of EDP1815 versus placebo in approximately 225 individuals, over a 16-week treatment period. The primary endpoint is mean reduction in PASI score.
EDP1815 in Atopic Dermatitis

In October, Evelo completed enrollment in the Phase 1b clinical trial cohort evaluating EDP1815 for the treatment of mild to moderate atopic dermatitis. The cohort is evaluating EDP1815 versus placebo in 24 individuals, over a 56-day treatment period. The primary endpoint is safety and tolerability.
EDP1815 in COVID-19

Patient recruitment continues in two studies evaluating EDP1815 for the treatment of newly hospitalized patients with COVID-19: the Phase 2 trial in partnership with Rutgers University, and TACTIC-E, a Phase 2/3 trial sponsored by the Cambridge University Hospitals NHS Foundation Trust and led by Addenbrooke’s Hospital in Cambridge, United Kingdom.
Evelo now expects to report data from the clinical trial in partnership with Rutgers University and interim safety data and futility analysis from TACTIC-E in 2Q 2021, depending on the prevalence of hospitalized patients with COVID-19. Subject to the receipt of positive data, Evelo plans to engage in discussions with global regulatory agencies to determine an appropriate path to registration for EDP1815 in COVID-19.
In order to expedite patient recruitment and expand access to potential therapies for COVID-19, new trial sites are being opened for TACTIC-E.
Business Highlights

In September 2020, Evelo appointed Julie Carretero as Chief People Officer. In her role, Ms. Carretero is responsible for leading the Company’s people initiatives, including talent acquisition and employee development.
In October 2020, the U.S. Patent and Trademark Office issued to Evelo U.S. Patent No. 10,792,314, entitled "Compositions and methods of treating cancer using Bifidobacterium animalis ssp. lactis." The patent covers a pharmaceutical composition formulated for oral administration comprising Bifidobacterium animalis ssp. Lactis Strain A and a pharmaceutically acceptable carrier within an enteric coating.
Upcoming Key Milestones
EDP1815

Data from Phase 1b trial in mild to moderate atopic dermatitis in 1Q 2021
Data from Phase 2 Rutgers University trial in COVID-19 in 2Q 2021
Interim safety data and futility analysis from Phase 2/3 TACTIC-E trial in COVID-19 in 2Q 2021
Interim data from Phase 2 trial in mild to moderate psoriasis by mid-2021
EDP1867

Data from Phase 1b trial in atopic dermatitis in mid-2021
EDP1503

Additional data from Phase 1/2 trial in triple-negative breast cancer (TNBC) accepted for poster presentation at the 2020 San Antonio Breast Cancer Symposium (SABSC), to be held virtually from December 8-11
EDP1908

Abstract titled "Oral delivery of a microbial extracellular vesicle induces potent anti-tumor immunity in mice," accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting, to be held virtually from November 11-14
Third Quarter 2020 Financial Results

Cash Position: As of September 30, 2020, cash and cash equivalents were $81.6 million, as compared to cash and cash equivalents of $77.8 million as of December 31, 2019. This increase was primarily due to $48.4 million in net proceeds from the Company’s June 2020 follow-on offering and draw down of an additional $10 million under its existing debt facility in July 2020, partially offset by cash used in operating activities. Evelo expects that its cash and cash equivalents will enable it to fund its planned operating expenses and capital expenditure requirements into the beginning of the third quarter of 2021.
Research and Development Expenses: R&D expenses were $14.9 million for the three months ended September 30, 2020, compared to $15.6 million for the three months ended September 30, 2019. The decrease of $0.7 million was primarily due to decrease in platform expenses and oncology program spend primarily driven by COVID-19 pandemic impact, partially offset by increases in inflammation programs and personnel costs due to advancing EDP1815 into Phase 2, additional trials and headcount increase in R&D.
General and Administrative Expenses: G&A expenses were $5.3 million for the three months ended September 30, 2020, compared to $5.9 million for the three months ended September 30, 2019. The decrease of $0.6 million was primarily due to lower personnel costs associated with temporarily lower general and administrative headcount and lower professional fees, partially offset by higher facility and office costs due to the impact of the COVID-19 pandemic.
Net Loss: Net loss was $20.9 million for the three months ended September 30, 2020, or $(0.45) per basic and diluted share, as compared to a net loss of $21.6 million for the three months ended September 30, 2019, or $(0.67) per basic and diluted share.
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 View Source 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.