Evelo Biosciences Reports Third Quarter 2018 Financial Results and Recent Business Highlights
-- Approval to Initiate Phase 1b Trial of EDP1815 in Psoriasis and Atopic Dermatitis: Dosing of First Patient Expected in 4Q18 --
-- Initiation of Investigator-Sponsored Phase 2a Trial of EDP1503 in Metastatic Melanoma Expected in 4Q18 --
"Our continued progress reflects our commitment to advancing a broad portfolio of product candidates to treat multiple diseases," said
Third Quarter and Recent Business Highlights:
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.
Upcoming Anticipated Milestones:
- 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, 2018in New York, New York. Evercore ISI Healthcare Conferenceon November 27, 2018in Boston, Massachusetts.
- BMO Prescriptions for
Success Healthcare Conferenceon December 12, 2018in New York, New York.
October 2018, Evelo appointed Daniel Charas 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 Schooland a B.A. in Economics from Tufts University.
Third Quarter 2018 Financial Results:
- 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 millionas of December 31, 2017. This increase was due to net proceeds of $81.3 millionfrom the issuance of Series C Preferred Stock, net proceeds of $75.8 millionfrom Evelo’s initial public offering and $5.0 millionof 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 expects that its cash, cash equivalents and investments will enable it to fund its planned operating expenses and capital expenditure requirements into the second half of 2020.
- Research and Development Expenses: R&D expenses were
$11.2 millionfor the three months ended September 30, 2018, compared to $5.3 millionfor the three months ended September 30, 2017. The increase of $5.9 millionwas 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 millionfor the three months ended September 30, 2018, compared to $2.7 millionfor the three months ended September 30, 2017. The increase of $2.5 millionwas 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) millionfor 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) millionfor the three months ended September 30, 2017, or $(2.61)per basic and diluted share.
Evelo currently has three product candidates, EDP1066 and EDP1815 for the treatment of inflammatory diseases and EDP1503 for the treatment of cancer, for which ten clinical readouts are expected during 2019 and 2020. Evelo is also advancing additional candidates through preclinical development in other disease areas.
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 our development plans, the promise and potential impact of any of our monoclonal microbials or preclinical or clinical trial data, timing of and plans to initiate clinical studies of EDP1503, EDP1066 and EDP1815, the timing and results of any clinical studies or readouts, and the sufficiency of cash to fund operations.
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 need for additional funding; our limited operating history; our unproven approach to therapeutic intervention; 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; a significant portion of our total outstanding shares are eligible to be sold into the market in the near future; costs and resources of operating as a public company; unfavorable or no analyst research or reports; 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 quarter ended
|EVELO BIOSCIENCES, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)|
|December 31, 2017|
|Cash, cash equivalents and investments||$||164,328||$||38,246|
|Property and equipment, net||6,069||3,496|
|Liabilities, preferred stock and stockholders’ equity (deficit):|
|Accounts payable and current liabilities||$||9,413||$||3,839|
|Convertible preferred stock||—||83,702|
|Total stockholders’ equity (deficit)||150,760||(54,723||)|
|Total liabilities, preferred stock and stockholders’ equity (deficit)||$||175,606||$||43,788|
|EVELO BIOSCIENCES, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|(in thousands, except share and per share amounts)|
|Three Months Ended
|Nine Months Ended
|Research and development||$||11,227||$||5,345||$||28,542||$||13,881|
|General and administrative||5,230||2,693||13,568||5,583|
|Total operating expenses||16,457||8,038||42,110||19,464|
|Loss from operations||(16,457||)||(8,038||)||(42,110||)||(19,464||)|
|Other income (expense), net||600||(135||)||607||(440||)|
|Preferred stock dividends||—||(1,708||)||(3,937||)||(4,355||)|
|Net loss attributable to common stockholders||$||(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|
Source: Evelo Biosciences, Inc.