Latest News by Industry
- Multiple Phase 2 readouts for EDP1815 in atopic dermatitis expected in 2023; data from first three cohorts expected in early 1Q 2023 and fourth cohort in 2Q 2023 -
- Phase 2 data for first extracellular vesicle product candidate EDP2939 in psoriasis anticipated in 2H 2023 –
- Continuing to advance r egulatory discussions for registration trials for EDP1815 in psoriasis -
CAMBRIDGE, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis, SINTAX, today announced its third quarter 2022 financial results and business highlights.
“We are on-track to deliver on three Phase 2 clinical milestones throughout 2023: first, early in the first quarter of 2023, data from the first three cohorts in the Phase 2 trial of EDP1815 in atopic dermatitis; second, in the second quarter of 2023, data from the fourth cohort - the faster release capsule – in the Phase 2 trial of EDP1815 in atopic dermatitis; and third, in the second half of 2023, data from patients in the Phase 2 trial of EDP2939, our first extracellular vesicle (EV) product candidate, in psoriasis” said Simba Gill, Ph.D., Chief Executive Officer of Evelo.
Dr. Gill continued, “We are pleased that the European Medicines Agency (EMA) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), through their respective scientific advice processes, acknowledged the appropriateness of our proposed registration clinical trial design for EDP1815 in psoriasis, including the primary and secondary endpoints. We have also received initial written feedback from the United States Food and Drug Administration (FDA) on the same topics and have requested a meeting to discuss our registration trial plans. We have the technical and manufacturing operations in place that we believe will allow for registration trials and commercial launch.”
Third Quarter 2022 Highlights and Upcoming Key Milestones
EDP1815 in Atopic Dermatitis: On-Track for Phase 2 Data Read-outs in Early 1Q 2023 (cohorts 1-3) and 2Q 2023 (cohort 4)
EDP2939 in Psoriasis: Dosing Expected in 1Q 2023; Phase 2 Data Anticipated in 2H 2023
EDP1815 in Psoriasis: Regulatory Feedback on Proposed Registration Trials
Recent Presentations
Third Quarter 2022 Financial Results (Unaudited)
Evelo Biosciences is a clinical stage biotechnology company developing a novel platform of orally delivered medicines acting on the small intestinal axis, SINTAX, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. 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. Evelo initially is developing EDP1815 in psoriasis and atopic dermatitis and EDP2939 in psoriasis. 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.
For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements, including 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 and EDP2939, the promise and potential impact of our product candidates, the timing of and plans for clinical trials, the timing and results of clinical trial readouts and the timing and nature of feedback from regulatory agencies.
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 projected cash runway; our need for additional funding; our ability to meet our debt obligations (including restrictive covenants) or refinance our debt on acceptable terms, if at all; our limited operating history; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the likelihood of regulatory filings and approvals; 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; the fact that we are subject to certain restrictive covenants under the terms of our loan and security agreements; 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 period ended September 30, 2022, and our other reports filed with the United States Securities and Exchange Commission, 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.
Contacts
Investors:
Kendra Sweeney, 239-877-7474
ksweeney@evelobio.com
Media:
Jessica Cotrone, 978-760-5622
jcotrone@evelobio.com
Evelo Biosciences, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 21,928 | $ | 22,599 | $ | 62,470 | $ | 64,762 | ||||||||
| General and administrative | 7,126 | 10,111 | 24,909 | 23,075 | ||||||||||||
| Total operating expenses | 29,054 | 32,710 | 87,379 | 87,837 | ||||||||||||
| Loss from operations | (29,054 | ) | (32,710 | ) | (87,379 | ) | (87,837 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest expense, net | (788 | ) | (1,023 | ) | (2,835 | ) | (2,602 | ) | ||||||||
| Loss on extinguishment of debt | — | — | — | (3,226 | ) | |||||||||||
| Other miscellaneous income (expense), net | (615 | ) | 159 | (386 | ) | 472 | ||||||||||
| Total other expense, net | (1,403 | ) | (864 | ) | (3,221 | ) | (5,356 | ) | ||||||||
| Loss before income taxes | (30,457 | ) | (33,574 | ) | (90,600 | ) | (93,193 | ) | ||||||||
| Income tax expense | (107 | ) | (156 | ) | (386 | ) | (331 | ) | ||||||||
| Net loss | $ | (30,564 | ) | $ | (33,730 | ) | $ | (90,986 | ) | $ | (93,524 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.28 | ) | $ | (0.63 | ) | $ | (1.14 | ) | $ | (1.77 | ) | ||||
| Weighted-average number of common shares outstanding, basic and diluted | 108,051,851 | 53,430,333 | 79,528,761 | 52,704,470 | ||||||||||||
Evelo Biosciences, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except per share and share)
(Unaudited)
| September 30, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 69,053 | $ | 68,441 | ||||
| Prepaid expenses and other current assets | 3,274 | 2,585 | ||||||
| Total current assets | 72,327 | 71,026 | ||||||
| Property and equipment, net | 5,455 | 6,622 | ||||||
| Right of use asset - operating lease | 7,398 | 8,910 | ||||||
| Other assets | 1,156 | 1,313 | ||||||
| Total assets | $ | 86,336 | $ | 87,871 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Debt, current portion | $ | 10,095 | $ | — | ||||
| Accounts payable | 1,550 | 1,601 | ||||||
| Accrued expenses | 12,478 | 13,068 | ||||||
| Operating lease liability, current portion | 2,177 | 1,951 | ||||||
| Other current liabilities | 617 | 742 | ||||||
| Total current liabilities | 26,917 | 17,362 | ||||||
| Noncurrent liabilities: | ||||||||
| Debt, net of current portion | 36,650 | 46,557 | ||||||
| Operating lease liability, net of current portion | 5,935 | 7,785 | ||||||
| Deferred revenue | 7,500 | 7,500 | ||||||
| Total liabilities | 77,002 | 79,204 | ||||||
| Stockholder’s equity: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding as of September 30, 2022 and December 31, 2021, respectively | — | — | ||||||
| Common stock, $0.001 par value; 200,000,000 shares authorized; 108,473,091 and 53,576,454 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 108 | 54 | ||||||
| Additional paid-in capital | 514,907 | 423,308 | ||||||
| Accumulated deficit | (505,681 | ) | (414,695 | ) | ||||
| Total stockholders’ equity | 9,334 | 8,667 | ||||||
| Total liabilities and stockholders’ equity | $ | 86,336 | $ | 87,871 | ||||