Evelo Biosciences Reports Second Quarter 2020 Financial Results and Business Highlights

– FDA authorization of IND for Phase 2 trial of EDP1815 in COVID-19 in the U.S.; data expected in 4Q 2020 –
–Achieved regulatory and ethics authorization for Phase 2 dose ranging trial for EDP1815 in moderate psoriasis in the U.S., UK, and EU; trial initiation expected in 3Q 2020 with interim data expected by mid-2021–
–Additional data from Phase 1/2 trial of EDP1503 in TNBC expected in 4Q 2020–
–Up to 6 clinical readouts expected over next 6-12 months–
–Management to host conference call at 8:30 a.m. ET–

CAMBRIDGE, Mass., July 30, 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 second quarter 2020.

“Our preclinical and clinical data support advancing our programs in psoriasis, COVID-19, atopic dermatitis, and triple-negative breast cancer (TNBC), with multiple clinical readouts expected over the next 6-12 months. In parallel, we continue to advance our preclinical programs in inflammation, oncology, neuroinflammation, and metabolism,” said Simba Gill, Ph.D., chief executive officer of Evelo. “Our recently completed follow-on offering provides the capital to pursue these clinical activities whilst continuing to explore additional opportunities to capture the therapeutic potential of SINTAX.”

Second Quarter 2020 Highlights and Recent Progress

Inflammation

EDP1815 in Moderate Psoriasis

• Evelo has received regulatory and ethics authorization for its Phase 2 dose ranging trial at sites in the U.S., UK, and EU. The Company is on-track to initiate the trial in 3Q 2020.
• The trial will evaluate three doses of EDP1815 versus placebo in approximately 225 individuals with moderate psoriasis. The primary endpoint will be mean reduction in PASI score at 16 weeks.

EDP1815 in COVID-19

• EDP1815 will be evaluated in two clinical trials for the treatment of hospitalized patients with COVID-19: a Phase 2 trial in partnership with Rutgers University and Robert Wood Johnson University Hospital, 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.
• The U.S. Food and Drug Administration (FDA) recently authorized the Company’s Investigational New Drug (IND) application for the Phase 2 trial in the U.S.

Oncology

EDP1503

• In July 2020, Evelo presented clinical data from its Phase 1/2 open-label study of EDP1503, in combination with pembrolizumab, at the ESMO World Congress on Gastrointestinal Cancer Virtual Meeting.
• The clinical trial included patients with advanced metastatic microsatellite stable colorectal carcinoma (MSS CRC), TNBC, and those with multiple tumor types who have relapsed on prior checkpoint inhibitor treatment.  
• Preliminary data on 11 TNBC patients (8 on high dose and 3 on low dose EDP1503) was presented. The data showed an overall response rate (ORR) of 25% (2/8) and a disease control rate of 37.5% (3/8) across all TNBC patients receiving high dose EDP1503.

Business Highlights

• In June 2020, Evelo completed a public offering of 13.8 million shares of its common stock, including the underwriter’s option to purchase additional shares, at a public offering price of $3.75 per share, before underwriting discounts and commissions, raising approximately $52 million in gross proceeds. Additionally, in July 2020, Evelo drew down an additional $10 million under its existing loan and security agreement with K2HealthVentures.
• The U.S. Patent and Trademark Office has issued to Evelo U.S. Patent No. 10,702,561 entitled “Pharmaceutical compositions comprising a Blautia strain.” The patent relates to a pharmaceutical composition formulated for oral administration comprising a therapeutically effective amount of a Blautia strain. This is the second patent in this family.

Upcoming Key Milestones

EDP1815

• Data from Phase 2 trial in COVID-19 in 4Q 2020
• Interim safety data and futility analysis from Phase 2/3 TACTIC-E trial in 4Q 2020
• Data from Phase 1b trial in atopic dermatitis in 1Q 2021
• Interim data from Phase 2 trial in 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 TNBC in 4Q 2020

Second Quarter 2020 Financial Results

• Cash Position: As of June 30, 2020, cash and cash equivalents were $90.2 million, as compared to cash and cash equivalents of $77.8 million as of December 31, 2019. This increase was primarily due to $48.6 million in net proceeds received from the Company’s June 2020 follow-on underwritten public offering, partially offset by cash used in operating activities. Evelo now expects that its cash and cash equivalents, including the $10 million additional debt, will enable it to fund its planned operating expenses and capital expenditure requirements into the third quarter of 2021.
• Research and Development Expenses: R&D expenses were $15.2 million for the three months ended June 30, 2020, compared to $15.5 million for the three months ended June 30, 2019. The decrease of $0.3 million was primarily due to the impact of COVID-19, which delayed the trial initiation and patient recruitment across inflammation and oncology programs and reduced lab and external manufacturing activities, partially offset by continuous investment in R&D hiring and headcount growth.
• General and Administrative Expenses: G&A expenses were $5.1 million for the three months ended June 30, 2020, compared to $5.9 million for the three months ended June 30, 2019. The decrease of $0.8 million primarily reflects a $0.4 million decrease in lower travel and office expenditure due to the COVID-19 pandemic, and a $0.4 million decrease in personnel costs due to temporary lower G&A headcount.
• Net Loss: Net loss was $20.7 million for the three months ended June 30, 2020, or $(0.63) per basic and diluted share, as compared to a net loss of $20.9 million for the three months ended June 30, 2019, or $(0.65) 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 7048016. 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 four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19, and EDP1503 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.