“We continued to progress on our SINTAX platform and our clinical pipeline in 2022. We look forward to important clinical milestones in 2023. On mechanism of action, we have shown that the action of SINTAX medicines in the small intestine generates systemically circulating regulatory T cells. These T cells have the potential to induce durable resolution of inflammation throughout the body, as observed in Part B of the EDP1815 Phase 2 study in psoriasis announced in 2022,” said
2022 Highlights
- In
February 2022 , the Company reported data from Part B of EDP1815 Phase 2 trial in psoriasis, demonstrating durable and deepening responses in the post-treatment period.- 18/30 patients maintained a PASI-50 or greater response
- 9/20 patients experienced a deepening of response from PASI-50 to at least PASI-75
- In
May 2022 , the Company raised$79.2 million through a Registered Direct Offering of common stock, led by Flagship Pioneering with participation from key existing and new investors. - In
December 2022 , Evelo refinanced its existing$45 million debt by executing a loan and security agreement with Horizon Technology Finance, which provides for three years of interest-only payments, followed by a two-year amortization period. - Evelo received feedback from the
U.S. Food and Drug Administration (“FDA”),European Medicines Agency (“EMA”) and Medicines and Healthcare products Regulatory Agency (“MHRA") regarding a proposed Phase 3 study of EDP1815 in psoriasis, advancement into which is funding dependent, including the following:- Agreement on primary endpoint of PGA 0/1 with a 2-point improvement
- No need for active comparator in
Europe , with placebo control acceptable in the mild-to-moderate population - Alignment on Chemistry, Manufacturing and Controls plan for release and stability testing panels
- Evelo published a peer-reviewed article in Frontiers in Immunology explaining the scientific basis of the Small Intestinal Axis (“SINTAX”).
Upcoming Milestones
EDP1815 – Atopic Dermatitis
- Data from a fourth patient cohort of the Phase 2 study in atopic dermatitis evaluating the faster release capsule is anticipated in 2Q 2023.
- Cohorts one, two and three did not meet the primary endpoint of
EASI -50 improvement as compared to placebo, due to an unusually high placebo response. No conclusions regarding the cause of the high placebo response have been identified.
EDP2939 – Psoriasis
- A safety and tolerability review was conducted in a first cohort of healthy volunteers in the Phase 1 portion of the trial, with no safety or tolerability concerns identified and resulting in approval to start the Phase 2 part of the trial.
- In
February 2023 , Evelo began dosing psoriasis patients in the Phase 2 portion of the trial, with data expected 2H 2023. - Safety and tolerability assessment of multiple ascending dose cohorts continues, as the Company anticipates conducting additional dose-ranging studies following acceptable safety and tolerability data.
Fourth Quarter and Full Year 2022 Financial Results (Unaudited)
- Cash Position: As of
December 31, 2022 , cash and cash equivalents were$47 .9 million, as compared to cash and cash equivalents of$68 .4 million as ofDecember 31, 2021 . - Research and Development Expenses: R&D expenses were
$16 .1 million and$78 .6 million for the three and twelve-month periods endedDecember 31, 2022 , compared to$18 .9 million and$83 .6 million for the three and twelve-month periods endedDecember 31, 2021 , respectively. - General and Administrative Expenses: G&A expenses were
$5 .0 million and$29 .9 million for the three and twelve-month periods endedDecember 31, 2022 , compared to$8 .7 million and$31 .8 million for the three and twelve-month periods endedDecember 31, 2021 , respectively. - Net Loss: Net loss was
$23 .5 million and$114 .5 million for the three and twelve-month periods endedDecember 31, 2022 , compared to$28 .7 million and$122 .2 million for the three and twelve-month periods endedDecember 31, 2021 , respectively.
Conference Call
Evelo will host a conference call and webcast at
About
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 expected timing and advancement of, and data results from, trials and clinical studies involving our product candidates.
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: 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 and operational covenants and terms of refinanced debt); our ability to cure or satisfactorily resolve any default arising from our debt agreements; 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 operate with a reduced workforce, to manage potential growth and to retain key personnel, particularly following a significant downsizing; 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 impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; and securities class action litigation against us.
These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended
Contacts
Investors:
ir@evelobio.com
Media:
media@evelobio.com
Consolidated Statements of Operations (Unaudited)
(In thousands, except per share and share amounts)
Three Months Ended | Year Ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 16,084 | $ | 18,881 | $ | 78,554 | $ | 83,643 | |||||||
General and administrative | 5,003 | 8,678 | 29,912 | 31,753 | |||||||||||
Total operating expenses(1) | 21,087 | 27,559 | 108,466 | 115,396 | |||||||||||
Loss from operations | (21,087 | ) | (27,559 | ) | (108,466 | ) | (115,396 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest expense, net | (1,837 | ) | (1,010 | ) | (4,672 | ) | (3,612 | ) | |||||||
Loss on extinguishment of debt | (520 | ) | — | (520 | ) | (3,226 | ) | ||||||||
Other miscellaneous income, net | 447 | 14 | 61 | 486 | |||||||||||
Total other expenses, net | (1,910 | ) | (996 | ) | (5,131 | ) | (6,352 | ) | |||||||
Loss before income taxes | (22,997 | ) | (28,555 | ) | (113,597 | ) | (121,748 | ) | |||||||
Income tax expense | (544 | ) | (97 | ) | (930 | ) | (428 | ) | |||||||
Net loss | $ | (23,541 | ) | $ | (28,652 | ) | $ | (114,527 | ) | $ | (122,176 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.21 | ) | $ | (0.54 | ) | $ | (1.31 | ) | $ | (2.31 | ) | |||
Weighted average number of common shares outstanding, basic and diluted | 109,839,320 | 53,515,636 | 87,168,683 | 52,910,982 |
(1) Expenses include the following amount of non-cash stock-based compensation expense.
Three Months Ended | Year Ended December 31, | ||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||
General and administrative | $ | 1,712 | $ | 2,290 | $ | 8,018 | $ | 7,842 | |||
Research and development | 1,709 | 2,079 | 7,140 | 8,004 | |||||||
Total stock-based compensation expense | $ | 3,421 | $ | 4,369 | $ | 15,158 | $ | 15,846 |
Consolidated Balance Sheets (Unaudited)
(In thousands, except share amounts)
2022 | 2021 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 47,940 | $ | 68,441 | |||
Prepaid expenses and other current assets | 3,633 | 2,585 | |||||
Total current assets | 51,573 | 71,026 | |||||
Property and equipment, net | 4,842 | 6,622 | |||||
Right of use asset - operating lease | 6,868 | 8,910 | |||||
Other assets | 1,158 | 1,313 | |||||
Total assets | $ | 64,441 | $ | 87,871 | |||
Liabilities and stockholders’ (deficit) equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,764 | $ | 1,601 | |||
Accrued expenses | 7,945 | 13,068 | |||||
Operating lease liability, current portion | 2,259 | 1,951 | |||||
Other current liabilities | 427 | 742 | |||||
Total current liabilities | 12,395 | 17,362 | |||||
Noncurrent liabilities: | |||||||
Debt, net of current portion | 43,614 | 46,557 | |||||
Operating lease liability, net of current portion | 5,265 | 7,785 | |||||
Deferred revenue | 7,500 | 7,500 | |||||
Other noncurrent liabilities | 659 | — | |||||
Total liabilities | 69,433 | 79,204 | |||||
Commitments and contingencies (Note 10) | |||||||
Stockholder’s (deficit) equity: | |||||||
Preferred stock, | — | — | |||||
Common stock, | 111 | 54 | |||||
Additional paid-in capital | 524,119 | 423,308 | |||||
Accumulated deficit | (529,222 | ) | (414,695 | ) | |||
Total stockholders’ (deficit) equity | (4,992 | ) | 8,667 | ||||
Total liabilities and stockholders’ (deficit) equity | $ | 64,441 | $ | 87,871 |
Source:
2023 GlobeNewswire, Inc., source