On April 29, 2021 Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, reported financial results and business highlights for the first quarter 2021 (Press release, Evelo Biosciences, APR 29, 2021, View Source [SID1234578797]).
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"Over the past year, we have executed on our research and development plans, providing critical preclinical and clinical data to help inform our late-stage development plans, and further validating our platform. We are poised to continue building on this momentum, with multiple clinical readouts expected across our inflammatory disease portfolio in the next 18 months, including our Phase 2b data from EDP1815 in psoriasis in the third quarter," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "In order to support this rapid growth, we continue to strengthen our corporate position. We recently expanded our executive team with the addition of Luca Scavo as CFO and Julie H. McHugh to our Board of Directors, and entered into a strategic collaboration with Abdul Latif Jameel Health to potentially provide EDP1815 to the Middle East, Turkey, and Africa, representing a key step in realizing our vision of providing safe, effective, convenient, and affordable medicines to millions of people around the world."
First Quarter 2021 Highlights and Recent Progress
EDP1815 in Atopic Dermatitis
In April 2021, Evelo presented full clinical data from the Phase 1b clinical trial cohort evaluating EDP1815 for the treatment of mild and moderate atopic dermatitis in a poster presentation at the International Society of Atopic Dermatitis (ISAD) Hybrid Meeting 2021. The Company previously reported positive data for all 24 patients in the cohort, which is re-iterated in the presentation, together with new data on the Investigator Global Assessment (IGA) score.
The full results reinforce the data released in January 2021, demonstrating that treatment with EDP1815 resulted in clinically meaningful improvements in both patient- and physician-reported outcomes.
At the day 70 follow-up visit, 31% more EDP1815-treated patients achieved an IGA score of 0 or 1 greater than placebo. At this same time-point, 19% more EDP1815-treated patients reached an IGA score of 0 or 1 with a two-point improvement from baseline greater than placebo.
These data, in addition to the treatment differences seen within the Eczema Area and Severity Index (EASI), SCORing Atopic Dermatitis (SCORAD), and IGA times Body Surface Area (IGA*BSA) clinical endpoints, suggest the potential of EDP1815 to be a safe, effective, well-tolerated, oral treatment for patients with mild and moderate atopic dermatitis.
As previously disclosed, EDP1815 was well tolerated, with no treatment-related adverse events of moderate or severe intensity and no serious adverse events.
EDP1815 TACTIC-E Trial in COVID-19
The planned review of interim data after the first 90 patients enrolled in the trial (including 30 patients treated with EDP1815) was conducted by the Independent Data Monitoring Committee in accordance with the protocol. No safety issues for EDP1815 were identified. The trial has therefore proceeded with continued recruitment. The next review of safety and efficacy data will be after approximately 125 patients have been enrolled into the EDP1815 arm of the trial.
Business Highlights
In March 2021, Evelo announced a strategic collaboration with Abdul Latif Jameel Health to develop and commercialize EDP1815 in the Middle East, Turkey, and Africa. The collaboration leverages Evelo’s leadership in inflammatory diseases and Abdul Latif Jameel’s regional distribution expertise, with the goal of accelerating the delivery of EDP1815 as an effective, affordable medicine to people in select developing markets, many of whom suffer significant challenges in accessing medical care. Under the terms of the agreement, Evelo received an upfront payment and equity investment. Evelo will be responsible for the development and manufacturing of EDP1815, whilst Abdul Latif Jameel Health will be responsible for regulatory submissions and commercialization activities in the agreed-upon regions. Evelo and Abdul Latif Jameel Health will participate in a 50:50 profit share arrangement.
In April 2021, Evelo announced the appointments of Luca Scavo as Chief Financial Officer and a member of the Evelo Leadership Team, effective June 1, 2021, and Julie H. McHugh to the Board of Directors, effective immediately.
Upcoming Key Milestones
EDP1815 – Psoriasis; all data anticipated to be reported in 3Q 2021
Data from Phase 1b cohorts with tablets and capsules
Full data from Phase 2b dose-ranging trial
EDP1815 – Atopic Dermatitis
Subject to regulatory approval, initiation of Phase 2 trial in 3Q 2021
EDP1815 – COVID-19
While patient accrual for both COVID-19 trials continued during the quarter, given the increase in vaccination rates, and lower number of patients hospitalized with COVID-19 at clinical trial sites, Evelo expects the trials will continue longer than originally planned. The Company is unsure when it will be able to report data, and therefore will no longer be issuing guidance related to these trials.
EDP1867 – Atopic Dermatitis
Interim data from Phase 1b trial expected in 4Q 2021
EDP2939 – Inflammation
Initiation of clinical development in 2022
EDP1908 – Oncology
Initiation of clinical development in 2022
First Quarter 2021 Financial Results
Cash Position: As of March 31, 2021, cash and cash equivalents were $124.6 million, as compared to cash and cash equivalents of $68.9 million as of December 31, 2020. This increase was primarily due to net proceeds of $82.0 million received from the Company’s issuance of common stock, partially offset by cash used to fund operating activities and capital expenditures in the first quarter of 2021.
Research and Development Expenses: R&D expenses were $21.5 million for the three months ended March 31, 2021, compared to $17.4 million for the three months ended March 31, 2020. The increase of $4.1 million was primarily due to increased costs related to Evelo’s inflammation clinical development programs and personnel costs, partially offset by decrease in R&D platform and oncology programs.
General and Administrative Expenses: G&A expenses were $6.0 million for the three months ended March 31, 2021, compared to $5.8 million for the three months ended March 31, 2020. The increase of $0.1 million was primarily due to increased personnel costs and other costs.
Net Loss: Net loss was $28.2 million for the three months ended March 31, 2021, or $(0.55) per basic and diluted share, as compared to a net loss of $23.0 million for the three months ended March 31, 2020, or $(0.71) per basic and diluted share.
Conference Call
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 5856668. 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.