CAMBRIDGE, Mass., Aug. 14, 2023 (GLOBE NEWSWIRE) — Evelo Biosciences, Inc. (Nasdaq: EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered inflammation-resolving medicines acting on the small intestinal axis (SINTAX), today announced its second quarter 2023 financial results and recent business highlights.
Simba Gill, Ph.D., Evelo’s Chief Executive Officer, said, “We are on track for a top line read-out from our ongoing Phase 2 study in moderate psoriasis with EDP2939, our first medicine based on microbial extracellular vesicles, early in the fourth quarter. EDP2939 is a next generation product candidate that builds on previously reported positive Phase 2 clinical data in psoriasis with our first-generation product, EDP1815. EDP2939 has the potential, if approved, to be effective, safe and well tolerated, as well as affordably priced. We believe this target product profile is well positioned for the vast majority of the millions of patients who suffer from moderate and milder forms of inflammatory diseases and who are not well served by other medicines, including antibodies and the newer immunomodulatory small molecules.”
Dr. Gill continued, “With our recent financing combined with the restructuring and reduction of our debt, we now have the financial resources to take us past the Phase 2 clinical readout of EDP2939 and into the first quarter of 2024.”
Recent Business Highlights and Upcoming Milestone
- The ongoing Phase 2 study with EDP2939 in moderate psoriasis is fully enrolled and on track for top line data readout in early Q4 2023.
- The Company completed a private placement in July 2023, resulting in gross proceeds of approximately $25.5 million. At the same time, the Company restructured its debt agreement with Horizon Technology Finance Corporation, paying down $5.0 million of its existing debt, and converting a further $5.0 million from debt to equity.
- The Company effected a 1-for-20 reverse stock split of its common stock effective with trading commencing on a split-adjusted basis on June 30, 2023.
- In July 2023, the Company announced it had entered into an agreement with its landlord to terminate the lease on its office and laboratory space, previously scheduled to terminate on September 30, 2025, effective as of September 15, 2023.
Second Quarter 2023 Financial Results (Unaudited)
- Cash Position: As of June 30, 2023, cash and cash equivalents were $7.6 million, as compared to cash and cash equivalents of $47.9 million as of December 31, 2022.
- Research and Development (R&D) Expenses: R&D expenses were $13.0 million for the three months ended June 30, 2023, compared to $21.2 million for the three months ended June 30, 2022. R&D expenses were $30.9 million for the six months ended June 30, 2023, compared to $40.5 million for the six months ended June 30, 2022.
- General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for the three months ended June 30, 2023, compared to $8.4 million for the three months ended June 30, 2022. G&A expenses were $12.0 million for the six months ended June 30, 2023, compared to $17.8 million for the six months ended June 30, 2022.
- Net Loss: Net loss was $21.1 million for the three months ended June 30, 2023, compared to $30.6 million for the three months ended June 30, 2022. Net loss was $46.4 million for the six months ended June 30, 2023, compared to $60.4 million for the six months ended June 30, 2022.
About the EDP2939 Trial
EDP2939-101 is a multi-center randomized, placebo-controlled, Phase 1/2 trial evaluating the safety, tolerability and clinical efficacy of EDP2939. Part A (Phase 1) of the trial is designed to determine safety and tolerability in human volunteers at multiple ascending doses. The primary endpoints of the Phase 1 are safety endpoints: AEs, SAEs, vital signs, safety laboratory tests, and ECGs.
Part B (Phase 2) is designed to determine the efficacy of EDP2939 in patients with moderate plaque psoriasis at the proposed therapeutic dose. The primary endpoint of the Phase 2 is the proportion of patients who achieve an outcome of a 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) score (a PASI-50 response) after 16 weeks of daily oral administration of EDP2939 or placebo. Secondary endpoints include several physician- and patient-reported psoriasis outcomes, as well as further safety evaluation. The trial will comprise approximately 110 patients randomized 1:1 to receive a single capsule of either EDP2939 or a matching placebo.
About Evelo Biosciences
Evelo Biosciences is a clinical stage biotechnology company developing a novel platform of orally delivered anti-inflammatory medicines acting on the small intestinal axis, SINTAX, with systemic therapeutic effects. The small intestine plays a central role in governing inflammation throughout the body. The Company’s product candidates are pharmaceutical preparations of single strains of microbes or their extracellular vesicles (“EVs”). Evelo’s vision is to create therapies that are effective, safe, well-tolerated, and affordable to improve the lives of the billions of people living with inflammatory diseases. If shown to be effective in inflammatory disease mediated by the Th1, Th2 or Th17 inflammatory pathways, these same investigational medicines could be effective in additional inflammatory diseases, such as psoriatic and other forms of arthritis, asthma, allergy, and inflammatory bowel disease. Evelo was founded by Flagship Pioneering.
For more information, please visit www.evelobio.com.
