Delaware | 001-38473 | 46-5594527 | ||
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
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☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Exhibit No. | Description | |
Press Release issued on November 1, 2018 |
EVELO BIOSCIENCES, INC. | |||
Date: November 1, 2018 | By: | /s/ Jonathan Poole | |
Jonathan Poole | |||
Chief Financial Officer |
• | In September 2018, the UK Medicines and Healthcare Regulatory Agency (MHRA) accepted Evelo’s Clinical Trial Authorisation application for a Phase 1b study of EDP1815 for the treatment of psoriasis and atopic dermatitis patients. |
• | Initiation of a Phase 1b clinical trial of EDP1815, an anti-inflammatory monoclonal microbial product candidate, in healthy volunteers and patients with psoriasis and atopic dermatitis in the fourth quarter of 2018. |
• | Initiation of the University of Chicago’s investigator-sponsored, open-label Phase 2a clinical trial of EDP1503 in combination with a checkpoint inhibitor in patients with metastatic melanoma in the fourth quarter of 2018. |
• | Initiation of a company-sponsored Phase 2a clinical trial of EDP1503 in combination with a checkpoint inhibitor in patients with multiple cancer types in the first half of 2019. |
• | Clinical data from the ongoing Phase 1b clinical trial of EDP1066 in healthy volunteers and patients with psoriasis and atopic dermatitis in the first half of 2019. |
• | Stifel 2018 Healthcare Conference on November 14, 2018 in New York, New York. |
• | Evercore ISI Healthcare Conference on November 27, 2018 in Boston, Massachusetts. |
• | BMO Prescriptions for Success Healthcare Conference on December 12, 2018 in New York, New York. |
• | In October 2018, Evelo appointed Daniel Char as general counsel. Daniel joins Evelo from Smith & Nephew, where he was the associate general counsel - commercial, responsible for advising and supporting the company’s global businesses on commercial, compliance, regulatory, clinical, licensing, manufacturing and international trade matters. Daniel earned a J.D. from Harvard Law School and a B.A. in Economics from Tufts University. |
• | Cash Position: As of September 30, 2018, cash, cash equivalents and investments were $164.3 million, as compared to cash and cash equivalents of $38.2 million as of December 31, 2017. This increase was due to net proceeds of $81.3 million from the issuance of Series C Preferred Stock, net proceeds of $75.8 million from Evelo’s initial public offering and $5.0 million of additional drawings from Evelo’s existing debt facility, partially offset by cash used to fund operating activities for the first nine months of 2018. Evelo |
• | Research and Development Expenses: R&D expenses were $11.2 million for the three months ended September 30, 2018, compared to $5.3 million for the three months ended September 30, 2017. The increase of $5.9 million was due primarily to increases in costs related to Evelo’s inflammation and oncology clinical development programs, gut-body network platform expenses as well as increased personnel costs. |
• | General and Administrative Expenses: G&A expenses were $5.2 million for the three months ended September 30, 2018, compared to $2.7 million for the three months ended September 30, 2017. The increase of $2.5 million was due primarily to increased general and administrative personnel costs, professional and consulting fees, and facility expenses supporting Evelo’s growing organization and public company infrastructure. |
• | Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $(15.9) million for the three months ended September 30, 2018, or $(0.50) per basic and diluted share, as compared to a net loss attributable to common stockholders of $(9.9) million for the three months ended September 30, 2017, or $(2.61) per basic and diluted share. |
September 30, 2018 | December 31, 2017 | |||||||
Assets: | ||||||||
Cash, cash equivalents and investments | $ | 164,328 | $ | 38,246 | ||||
Property and equipment, net | 6,069 | 3,496 | ||||||
Other assets | 5,209 | 2,046 | ||||||
Total assets | $ | 175,606 | $ | 43,788 | ||||
Liabilities, preferred stock and stockholders’ equity (deficit): | ||||||||
Accounts payable and current liabilities | $ | 9,413 | $ | 3,839 | ||||
Long-term debt | 14,155 | 9,966 | ||||||
Other liabilities | 1,278 | 1,004 | ||||||
Total liabilities | 24,846 | 14,809 | ||||||
Convertible preferred stock | — | 83,702 | ||||||
Total stockholders’ equity (deficit) | 150,760 | (54,723 | ) | |||||
Total liabilities, preferred stock and stockholders’ equity (deficit) | $ | 175,606 | $ | 43,788 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Operating Expenses(1): | ||||||||||||||||
Research and development | $ | 11,227 | $ | 5,345 | $ | 28,542 | $ | 13,881 | ||||||||
General and administrative | 5,230 | 2,693 | 13,568 | 5,583 | ||||||||||||
Total operating expenses | 16,457 | 8,038 | 42,110 | 19,464 | ||||||||||||
Loss from operations | (16,457 | ) | (8,038 | ) | (42,110 | ) | (19,464 | ) | ||||||||
Other income (expense), net | 600 | (135 | ) | 607 | (440 | ) | ||||||||||
Net loss | $ | (15,857 | ) | $ | (8,173 | ) | $ | (41,503 | ) | $ | (19,904 | ) | ||||
Preferred stock dividends | — | (1,708 | ) | (3,937 | ) | (4,355 | ) | |||||||||
Net loss attributable to common stockholders | $ | (15,857 | ) | $ | (9,881 | ) | $ | (45,440 | ) | $ | (24,259 | ) | ||||
Net loss per share - basic and diluted | $ | (0.50 | ) | $ | (2.61 | ) | $ | (2.45 | ) | $ | (6.52 | ) | ||||
Weighted-average common shares used in computing net loss per share - basic and diluted | 31,741,683 | 3,779,728 | 18,532,408 | 3,721,531 |
(1) | Expenses include the following amount of non-cash stock-based compensation expense: |
Research and development | $ | 764 | $ | 224 | $ | 1,767 | $ | 439 | ||||||||
General and administrative | 831 | 211 | 2,727 | 467 |