– EDP2939 Phase 2 trial in moderate psoriasis fully enrolled with topline data expected early Q4 2023
– Completed
– Restructured and reduced secured debt with Horizon Technology Finance Corporation
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 onSeptember 30, 2025 , effective as ofSeptember 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 ofDecember 31, 2022 . - Research and Development (R&D) Expenses: R&D expenses were
$13 .0 million for the three months endedJune 30, 2023 , compared to$21 .2 million for the three months endedJune 30, 2022 . R&D expenses were$30 .9 million for the six months endedJune 30, 2023 , compared to$40 .5 million for the six months endedJune 30, 2022 . - General and Administrative (G&A) Expenses: G&A expenses were
$4 .9 million for the three months endedJune 30, 2023 , compared to$8 .4 million for the three months endedJune 30, 2022 . G&A expenses were$12 .0 million for the six months endedJune 30, 2023 , compared to$17 .8 million for the six months endedJune 30, 2022 . - Net Loss: Net loss was
$21 .1 million for the three months endedJune 30, 2023 , compared to$30 .6 million for the three months endedJune 30, 2022 . Net loss was$46 .4 million for the six months endedJune 30, 2023 , compared to$60 .4 million for the six months endedJune 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
For more information, please visit www.evelobio.com.
Forward Looking Statements
This press release contains forward-looking statements 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 regarding the development of EDP2939, the timing of and plans for clinical trials, the timing and results of clinical trial readouts, the potential benefits of the private placement and the restructuring of our debt agreement; the impact of the reverse stock split; the promise or potential of our product candidates and our anticipated financial performance, financial position and cash runway.
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 Evelo’s 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 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 and conduct our clinical trials; costs and resources of operating as a public company; and unfavorable global economic or political conditions. These and other important factors discussed under the caption "Risk Factors" in Evelo’s Quarterly Report on Form 10-Q filed with the
Contacts
Investors:
ir@evelobio.com
Media:
media@evelobio.com
Consolidated Balance Sheets (Unaudited)
(In thousands, except share amounts)
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 7,622 | $ | 47,940 | |||
Prepaid expenses and other current assets | 3,641 | 3,633 | |||||
Total current assets | 11,263 | 51,573 | |||||
Property and equipment, net | 2,369 | 4,842 | |||||
Right of use asset - operating lease | 5,765 | 6,868 | |||||
Other assets | 1,422 | 1,158 | |||||
Total assets | $ | 20,819 | $ | 64,441 | |||
Liabilities and stockholders’ deficit | |||||||
Current liabilities: | |||||||
Debt, current portion | $ | 43,915 | $ | — | |||
Accounts payable | $ | 3,765 | $ | 1,764 | |||
Accrued expenses | 5,151 | 7,945 | |||||
Operating lease liability, current portion | 2,690 | 2,259 | |||||
Other current liabilities | 20 | 427 | |||||
Total current liabilities | 55,541 | 12,395 | |||||
Noncurrent liabilities: | |||||||
Debt, net of current portion | — | 43,614 | |||||
Operating lease liability, net of current portion | 3,876 | 5,265 | |||||
Deferred revenue | 7,500 | 7,500 | |||||
Other noncurrent liabilities | 28 | 659 | |||||
Total liabilities | 66,945 | 69,433 | |||||
Stockholder’s deficit: | |||||||
Preferred stock, | — | — | |||||
Common stock, | 6 | 6 | |||||
Additional paid-in capital | 529,534 | 524,224 | |||||
Accumulated deficit | (575,666 | ) | (529,222 | ) | |||
Total stockholders’ deficit | (46,126 | ) | (4,992 | ) | |||
Total liabilities and stockholders’ deficit | $ | 20,819 | $ | 64,441 |
Consolidated Statements of Operations (Unaudited)
(In thousands, except per share and share amounts)
Three Months Ended | Six months ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 13,043 | $ | 21,221 | $ | 30,900 | $ | 40,542 | |||||||
General and administrative | 4,915 | 8,366 | 11,958 | 17,783 | |||||||||||
Impairment of property and equipment | 1,616 | — | 1,616 | — | |||||||||||
Total operating expenses | 19,574 | 29,587 | 44,474 | 58,325 | |||||||||||
Loss from operations | (19,574 | ) | (29,587 | ) | (44,474 | ) | (58,325 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest expense, net | (1,369 | ) | (1,020 | ) | (2,480 | ) | (2,047 | ) | |||||||
Change in fair value of warrants | 4 | — | 631 | — | |||||||||||
Other miscellaneous income, net | 69 | 209 | 257 | 229 | |||||||||||
Total other expenses, net | (1,296 | ) | (811 | ) | (1,592 | ) | (1,818 | ) | |||||||
Loss before income taxes | (20,870 | ) | (30,398 | ) | (46,066 | ) | (60,143 | ) | |||||||
Income tax expense | (233 | ) | (163 | ) | (378 | ) | (279 | ) | |||||||
Net loss | $ | (21,103 | ) | $ | (30,561 | ) | $ | (46,444 | ) | $ | (60,422 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (3.78 | ) | $ | (8.07 | ) | $ | (8.35 | ) | $ | (18.67 | ) | |||
Weighted average number of common shares outstanding, basic and diluted | 5,578,767 | 3,785,954 | 5,562,121 | 3,236,520 |
(1) Expenses include the following amount of non-cash stock-based compensation expense.
Three Months Ended | Six months ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Research and development | $ | 1,471 | $ | 1,701 | $ | 2,992 | $ | 3,737 | |||||||
General and administrative | 894 | 2,298 | 2,282 | 4,537 | |||||||||||
Total stock-based compensation expense | $ | 2,365 | $ | 3,999 | $ | 5,274 | $ | 8,274 |
Source:
2023 GlobeNewswire, Inc., source