EVLO Evelo Biosciences Inc.

8.34
+1.03  (+14%)
Previous Close 7.31
Open 7.41
52 Week Low 3.82
52 Week High 19.9283
Market Cap $445,341,755
Shares 53,398,292
Float 23,304,546
Enterprise Value $324,226,514
Volume 1,002,516
Av. Daily Volume 203,303
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Upcoming Catalysts

Drug Stage Catalyst Date
EDP1815
Mild to moderate psoriasis
Phase 2b
Phase 2b
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EDP1867
Atopic dermatitis
Phase 1b
Phase 1b
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EDP1815
Atopic dermatitis
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
EDP1503 and KEYTRUDA (pembrolizumab)
Melanoma
Phase 2a
Phase 2a
Phase 2a trial ongoing - no longer providing guidance as to timing of data.
EDP1503
Colorectal cancer; Triple-negative breast cancer
Phase 1/2
Phase 1/2
Phase 1/2 data presented at SABSC December 9, 2020 - objective response rate (ORR) of 18%.
EDP1815-205
COVID-19
Phase 2
Phase 2
Phase 3 trial ongoing. Company unsure when it will be able to report data.
EDP1815 - TACTIC-E
COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 trial ongoing. Company unsure when it will be able to report data.
EDP1066
Psoriasis or atopic dermatitis
Phase 1
Phase 1
Development to be discontinued - noted February 13, 2020.

Latest News

  1. CAMBRIDGE, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new type of orally delivered medicines, today announced that the U.S. Patent and Trademark Office has issued a new composition of matter patent (No. 11,090,341) for medicines comprising pharmaceutical compositions of Veillonella parvula bacteria.

    This patent is a key addition to the Company's substantial and growing intellectual property (IP) portfolio for treatments targeting the small intestinal axis, SINTAX™. The issued claims in this new patent cover formulations of Veillonella parvula for oral administration, including EDP1867, which is currently in a Phase 1b clinical trial for the treatment…

    CAMBRIDGE, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new type of orally delivered medicines, today announced that the U.S. Patent and Trademark Office has issued a new composition of matter patent (No. 11,090,341) for medicines comprising pharmaceutical compositions of Veillonella parvula bacteria.

    This patent is a key addition to the Company's substantial and growing intellectual property (IP) portfolio for treatments targeting the small intestinal axis, SINTAX™. The issued claims in this new patent cover formulations of Veillonella parvula for oral administration, including EDP1867, which is currently in a Phase 1b clinical trial for the treatment of atopic dermatitis.

    "The grant of this patent is further confirmation that pharmaceutical compositions containing single strains of naturally occurring bacteria selected for their potential therapeutic properties are patent-eligible," said Dr. Mark Bodmer, Chief Scientific Officer and President of R&D of Evelo. "These compositions do not occur in nature and so are patentable in a similar way to more conventional novel medicines. We are pleased that this has again been recognized by the U.S. Patent and Trademark Office, providing vital IP covering for Evelo's leading innovation in developing effective, safe, oral SINTAX medicines."

    "The patent specification also discloses the use of extracellular vesicles (EVs) derived from Veillonella as orally-delivered medicines," continued Dr. Bodmer. "Preclinical data suggest that EVs may be effective as oral gut-restricted medicines with systemic effects. Their physical properties may enable increased engagement of the small intestinal axis and, so, increased efficacy. Our first EV product candidate, EDP2939, is on-track to enter the clinic in 2022 as part of the continuing expansion of Evelo's product portfolio and its underlying IP."

    About Evelo Biosciences

    Evelo Biosciences is a clinical stage biotechnology company developing orally delivered medicines that act on SINTAX™, the small intestinal axis, to have systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems.



    Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.

    For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn

    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 concerning the patentability of our product candidates, our development plans and the promise and potential impact of 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: 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 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; 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 three months ended June 30, 2021 and our other reports filed with the SEC 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 



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  2. CAMBRIDGE, Mass., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, today announced the appointment of Iain McInnes, M.B.Ch.B, Ph.D., to its Board of Directors.

    "We are pleased to welcome Iain, a world-renowned leader in rheumatology and clinical immunology, to our Board of Directors," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "Over the course of his career, Iain has played an instrumental role in developing new treatments for inflammatory diseases, leading research efforts to understand the key cellular and molecular pathways that drive these conditions, and participating in numerous clinical trials of novel…

    CAMBRIDGE, Mass., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, today announced the appointment of Iain McInnes, M.B.Ch.B, Ph.D., to its Board of Directors.

    "We are pleased to welcome Iain, a world-renowned leader in rheumatology and clinical immunology, to our Board of Directors," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "Over the course of his career, Iain has played an instrumental role in developing new treatments for inflammatory diseases, leading research efforts to understand the key cellular and molecular pathways that drive these conditions, and participating in numerous clinical trials of novel biologic agents. His breadth of expertise will be critical as we progress our product portfolio in inflammatory diseases, advancing EDP1815 and EDP1867 through clinical development in psoriasis and atopic dermatitis and, ultimately, expanding into the many other related indications where inflammation is the underlying driver, and where we believe our novel platform of SINTAX™ medicines can deliver transformative benefit."

    Professor McInnes is a leader in the fields of rheumatoid and psoriatic arthritis research, with extensive experience conducting research and leading clinical trials and research programs on an international scale. He currently serves as the Vice Principal and Head of College to the College of Medical, Veterinary and Life Sciences, Muirhead Professor of Medicine, and Honorary Consultant Rheumatologist at the University of Glasgow in Scotland. Professor McInnes is the editor-in-chief for Considerations in Medicine and an associate editor for Annals of the Rheumatic Diseases at the BMJ, one of the top-five most cited general medical journals. In addition, he is immediate Past President of the European Alliance of Associations for Rheumatology (EULAR), Chair of the Steering Committee for the Cytokine Signaling Forum, Fellow of the Royal Society of Edinburgh, and Fellow of the Academy of Medical Sciences. Professor McInnes holds his Ph.D., M.B.Ch.B. and B.Sc., all from the University of Glasgow. Professor McInnes  is the recipient of several prestigious prizes in recognition of his work, including the Sir James Black Medal of the Royal Society of Edinburgh in 2017, the Heberden Medal of the British Society for Rheumatology in 2018, and the Carol-Nachman Prize for Rheumatology, Germany (the highest international award in rheumatology) in 2019. He was awarded a Commander of the Most Excellent Order of the British Empire (CBE) for services to medicine by Her Majesty the Queen in 2019.

    "Based on Evelo's clinical and preclinical data to-date, these product candidates have the potential to revolutionize the treatment of inflammatory diseases, with the goal of offering patients new options that control systemic inflammation and immunity, while also being safe, well-tolerated, and convenient to administer," said Professor McInnes. "I am very pleased to join the Evelo Board to support and help guide this highly innovative team to deliver the promise of SINTAX medicines to people around the world."

    About Evelo Biosciences

    Evelo Biosciences is a clinical stage biotechnology company developing orally delivered product candidates that are designed to act 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 first product candidates are pharmaceutical preparations of single strains of microbes selected for their potential to offer defined pharmacological properties. Evelo's therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases and cancer.

    Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.

    For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.

    Forward Looking Statements

    This press release contains forward-looking statements. 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 our product candidates and the promise and potential impact of 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 followingthe impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; that 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; issues with the 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 having 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; 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 three months ended June 30, 2021, and our other reports filed with the SEC 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 



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  3. –EDP1815 Phase 2b data in psoriasis expected in 3Q 2021–
    –Finalized design of Phase 2 clinical trial of EDP1815 in atopic dermatitis; start of trial anticipated in 3Q 2021–
    –Strengthened leadership team with appointment of Mark Plinio as Chief Commercial Officer–
    –Multiple clinical data readouts expected over next 6-12 months–
    –Management to host conference call at 8:30 a.m. ET–

    CAMBRIDGE, Mass., July 29, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, today reported financial results and business highlights for the second quarter 2021.

    "We have demonstrated in multiple cohorts in a Phase 1b clinical trial the potential of our platform…

    –EDP1815 Phase 2b data in psoriasis expected in 3Q 2021–

    –Finalized design of Phase 2 clinical trial of EDP1815 in atopic dermatitis; start of trial anticipated in 3Q 2021–

    –Strengthened leadership team with appointment of Mark Plinio as Chief Commercial Officer–

    –Multiple clinical data readouts expected over next 6-12 months–

    –Management to host conference call at 8:30 a.m. ET–

    CAMBRIDGE, Mass., July 29, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, today reported financial results and business highlights for the second quarter 2021.

    "We have demonstrated in multiple cohorts in a Phase 1b clinical trial the potential of our platform to create medicines that control systemic inflammation and immunity that are well-tolerated and easily administered. Over the next 6-12 months, we have a series of catalysts that will bring us closer to our mission of delivering on this promise to patients, beginning with data from our EDP1815 Phase 2 trial in psoriasis and the start of our EDP1815 Phase 2 trial in atopic dermatitis, both expected in 3Q 2021," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "Importantly, our efforts with EDP1815 and dermatological diseases are only the beginning. Consistent with our strategy and understanding of the breadth of our platform, we continue to explore ways to enhance and extend the applications of SINTAX-based medicines. We are progressing our next-generation extracellular vesicle (EV) candidates into the clinic next year. And, as we look ahead to later-stage development, we strengthened our team with the addition of Mark Plinio as Chief Commercial Officer. We have the resources and leadership in place to advance and expand our broad portfolio of product candidates that have the potential to be safe, well-tolerated, and affordable therapies for hundreds of millions of people around the world."

    Second Quarter 2021 Highlights and Recent Progress

    EDP1815 Phase 2 Trial in Atopic Dermatitis

    • Evelo announced that it has finalized the design of the EDP1815 Phase 2 clinical trial in atopic dermatitis.
    • The trial will be a 12-week, double-blind, placebo-controlled, multiple cohort trial in patients with mild, moderate, and severe atopic dermatitis.
    • Approximately 198 patients will be randomized to receive EDP1815, and 66 patients will be randomized to receive placebo. Patients will receive either 1 capsule once daily, 2 capsules once daily, or 1 capsule twice daily.
    • The primary endpoint will be the mean difference between EDP1815 and placebo in the percentage change from baseline in Eczema Area and Severity Index (EASI) score at week 12.
    • Secondary endpoints will include a number of physician-reported outcomes, such as Investigators Global Assessment (IGA), Body Surface Area (BSA), along with numerous patient-reported outcomes, such as Dermatology Life Quality Index (DLQI), itch using the daily peak pruritus numerical rating scale, and Patient Oriented Eczema Measure (POEM).
    • All trial participants who complete the 12-week trial will be eligible to enroll into an open-label extension trial where they will receive EDP1815.

    EDP2939 in Inflammatory Diseases

    • In May 2021, Evelo presented preclinical data for its extracellular vesicle (EV) product candidate, EDP2939, for the treatment of inflammatory diseases, at Virtual IMMUNOLOGY2021, the 104th Annual Meeting of the American Association of Immunologists (AAI).
    • In the preclinical study, mice undergoing a delayed-type hypersensitivity (DTH) reaction against keyhole limpet hemagglutinin (KLH) were treated with EDP2939, EDP2939 in combination with different antibodies, or with placebo.
    • These data suggest that EDP2939 requires the stimulation of both the TLR2 receptor and the IL-10 receptor, in addition to lymphocyte homing to the intestinal lymphoid tissue.
    • Also, in-vitro, EDP2939 induces TLR2-dependent release of IL-10. Fluorescent biodistribution analysis showed that EDP2939 was not detected outside the gastrointestinal tract.
    • The data suggest that treatment with EDP2939 resulted in broad-based resolution of inflammation and the establishment of immune homeostasis, with no apparent adverse safety or tolerability effects preclinically, providing key insights into the pharmacologic effects, mechanism of action, and biodistribution of EDP2939.

    Business Highlights

    • In June 2021, Evelo announced the appointment of Mark Plinio as Chief Commercial Officer and a member of the Evelo Leadership Team.

    Upcoming Key Milestones

    EDP1815 – Psoriasis; data anticipated to be reported in 3Q 2021

    • Data from Phase 2b dose-ranging trial
    • Data from Phase 1b cohorts with tablets and capsules

    EDP1815 – Atopic Dermatitis

    • Start of Phase 2 trial in 3Q 2021
    • Data from Phase 2 trial anticipated in 3Q 2022

    EDP1867 – Atopic Dermatitis

    • Interim data from Phase 1b trial anticipated in 4Q 2021

    EDP2939 – Inflammation

    • Initiation of clinical development in 2022

    EDP1908 – Oncology

    • Initiation of clinical development in 2022

    Second Quarter 2021 Financial Results

    • Cash Position: As of June 30, 2021, cash and cash equivalents were $123.3 million, as compared to cash and cash equivalents of $68.9 million as of December 31, 2020.
    • Research and Development Expenses: R&D expenses were $20.7 million for the three months ended June 30, 2021, compared to $15.2 million for the three months ended June 30, 2020. The $5.5 million increase was primarily due to increased costs related to Evelo's inflammation clinical development programs, personnel and R&D platform costs, partially offset by decrease in oncology program costs.
    • General and Administrative Expenses: G&A expenses were $7.0 million for the three months ended June 30, 2021, compared to $5.1 million for the three months ended June 30, 2020. The $1.9 million increase was primarily due to increased personnel, facility, and other costs.
    • Net Loss: Net loss was $31.6 million for the three months ended June 30, 2021, or $0.59 per basic and diluted share, as compared to a net loss of $20.7 million for the three months ended June 30, 2020, or $0.63 per basic and diluted share.

    Conference Call

    Evelo will host a conference call and webcast at 8:30 a.m. ET today. To access the call please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 1658301. A live webcast of the event will also be available under "News and Events" in the Investors section of Evelo's website at http://ir.evelobio.com. The archived webcast will be available on Evelo's website approximately two hours after the completion of the event and will be available for 30 days following the call.

    About Evelo Biosciences

    Evelo Biosciences is a clinical stage biotechnology company developing orally delivered product candidates that are designed to act 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 first product candidates are pharmaceutical preparations of single strains of microbes selected for their potential to offer defined pharmacological properties. Evelo's therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases and cancer.

    Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.

    For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.

    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 concerning the development of EDP1815 and our other product candidates, the promise and potential impact of our product candidates, the timing of and plans for clinical trials, and the timing and results of clinical trial readouts.

    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 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; 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 three months ended June 30, 2021 and our other reports filed with the SEC 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.

    Contact

    Jessica Cotrone, 978-760-5622

    jcotrone@evelobio.com

    Evelo Biosciences, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited, in thousands, except share and per share data)

      Three Months Ended

    June 30,
     Six Months Ended

    June 30,
      2021 2020 2021 2020
    Operating expenses:        
    Research and development $20,655    $15,174    $42,163    $32,593   
    General and administrative 7,001    5,071    12,964    10,913   
    Total operating expenses 27,656    20,245    55,127    43,506   
    Loss from operations (27,656)  (20,245)  (55,127)  (43,506) 
    Other (expense) income:        
    Interest expense, net (814)  (458)  (1,579)  (639) 
    Loss on extinguishment of debt (3,226)  —    (3,226)  —   
    Other income, net 151    140    313    606   
    Total Other expense, net (3,889)  (318)  (4,492)  (33) 
    Loss before income taxes (31,545)  (20,563)  (59,619)  (43,539) 
    Income tax expense (53)  (89)  (175)  (154) 
    Net loss $(31,598)  $(20,652)  $(59,794)  $(43,693) 
             
    Net loss per share attributable to common stockholders, basic and diluted $(0.59)  $(0.63)  $(1.14)  $(1.35) 
    Weighted-average number of common shares outstanding, basic and diluted 53,379,415    32,634,468    52,340,608    32,442,259   
             

    (1) Expenses include the following amount of non-cash stock-based compensation expense.



      Three Months Ended June 30,

      Six Months Ended June 30,

     
      2021

      2020    2021

      2020

     
    General and administrative $1,723   $1,010   $3,164   $1,899  
    Research and development 2,049   1,083   3,872   2,149  
    Total stock-based compensation expense $3,772   $2,093   $7,036   $4,048  

    Evelo Biosciences, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited, in thousands, except per share and share amounts)

      June 30, 2021 December 31,

    2020
    Assets    
    Current assets:    
    Cash and cash equivalents $123,333   $68,857  
    Prepaid expenses and other current assets 3,034   2,123  
    Total current assets 126,367   70,980  
    Property and equipment, net 7,520   7,478  
    Right of use asset - operating lease 9,856   10,757  
    Other assets 1,315   1,424  
    Total assets $145,058   $90,639  
    Liabilities and stockholders' equity    
    Current liabilities:    
    Accounts payable $2,319   $1,442  
    Accrued expenses 15,011   16,254  
    Operating lease liability, current portion 1,812   1,674  
    Other current liabilities 654   463  
    Total current liabilities 19,796   19,833  
    Noncurrent liabilities:    
    Long-term debt 46,482   30,048  
    Operating lease liability, net of current portion 8,924   9,989  
    Deferred revenue 7,500   —  
    Other noncurrent liabilities 263   284  
    Total liabilities 82,965   60,154  
    Total stockholders' equity 62,093   30,485  
    Total liabilities and stockholders' equity $145,058   $90,639  


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  4. CAMBRIDGE, Mass., July 22, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, today announced that it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, July 29, 2021, to report its second quarter 2021 financial results and discuss business highlights.

    To access the live conference call, please dial 866-795-3242 (domestic) or 409-937-8909 (international) and refer to conference ID 1658301. A live webcast of the event will also be available under "News and Events" in the Investors section of Evelo's website at http://ir.evelobio.com. The archived webcast will be available on Evelo's website approximately two hours after…

    CAMBRIDGE, Mass., July 22, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, today announced that it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, July 29, 2021, to report its second quarter 2021 financial results and discuss business highlights.

    To access the live conference call, please dial 866-795-3242 (domestic) or 409-937-8909 (international) and refer to conference ID 1658301. A live webcast of the event will also be available under "News and Events" in the Investors section of Evelo's website at http://ir.evelobio.com. The archived webcast will be available on Evelo's website approximately two hours after the completion of the event and will be available for 30 days following the call.

    About Evelo Biosciences

    Evelo Biosciences is a clinical stage biotechnology company developing orally delivered medicines that act on the small intestinal axis, SINTAX™, to have systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems.

    Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.

    For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.

    Contact

    Jessica Cotrone, 978-760-5622

    jcotrone@evelobio.com



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  5. CAMBRIDGE, Mass., July 14, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, announced that on July 12, 2021, Ayse Kocak commenced her services as Evelo's Head of International & Special Projects.

    In her role, Ms. Kocak will lead the strategic planning and execution of the Company's international expansion. In addition, she will also lead the Company's COVID-19 efforts, as well as other strategic initiatives, working closely with US Commercial leadership. Ms. Kocak brings significant experience in Global Commercial Operations, product development and launch, and Sales and Marketing in the US and international markets. Ms. Kocak joins…

    CAMBRIDGE, Mass., July 14, 2021 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, announced that on July 12, 2021, Ayse Kocak commenced her services as Evelo's Head of International & Special Projects.

    In her role, Ms. Kocak will lead the strategic planning and execution of the Company's international expansion. In addition, she will also lead the Company's COVID-19 efforts, as well as other strategic initiatives, working closely with US Commercial leadership. Ms. Kocak brings significant experience in Global Commercial Operations, product development and launch, and Sales and Marketing in the US and international markets. Ms. Kocak joins Evelo from PAAR, a strategic and advisory consulting business. Prior to PAAR, she was the CEO of Global Aesthetics Consolidated, leading expansion strategies across top global markets. She held roles of increasing responsibility across a variety of global Commercial functions at moksha8 Pharmaceuticals, Cerimon Pharmaceuticals, and Pfizer, where she held leading marketing roles at the launch and commercialization of Lipitor®, Viagra®, Norvasc®, Inspra®, Tikosyn® and Geodon® in the US, Europe, Latin America, and the Middle East and Africa.

    In connection with the commencement of Ms. Kocak's employment, the Company issued to Ms. Kocak (i) an option to purchase 75,000 shares of the Company's common stock (the "First Stock Option"), (ii) an option to purchase 75,000 shares of the Company's common stock (the "Second Stock Option"), and (iii) an option to purchase 100,000 shares of the Company's common stock (the "Third Stock Option"), each with a per share exercise price of $13.90, the closing trading price of the Company's common stock on the Nasdaq Global Select Market on July 12, 2021. The First Stock Option vests (subject to Ms. Kocak's continued service to the Company through the applicable vesting dates) 25% on July 12, 2022, and in 36 substantially equal monthly installments over the three years thereafter and has a ten-year term. The Second Stock Option vests upon the approval (including emergency use authorization) by the U.S. Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency, the European Medicines Agency, the China National Medical Products Administration, the Japanese Pharmaceuticals and Medical Devices Agency or another significant regulatory agency (as determined by the Compensation Committee of the Company's Board of Directors) of a Company product candidate for commercial sales, marketing and distribution as a therapeutic for the treatment of patients with COVID-19 and has a ten-year term. The Third Stock Option vests upon the commencement by the Company of commercial sales in the United States, the United Kingdom, the European Union, China, Japan or another significant market (as determined by the Compensation Committee) of a Company product as a therapeutic for the treatment of patients with COVID-19 and has a ten-year term. The three stock options were granted pursuant to the Company's 2021 Employment Inducement Award Plan and were approved by the Compensation Committee of the Company's Board of Directors. The three stock options were granted under Rule 5635(c)(4) of the Nasdaq Listing Rules as an inducement material to Ms. Kocak's entering into employment with the Company.

    About Evelo Biosciences

    Evelo Biosciences is a clinical stage biotechnology company developing orally delivered medicines that act on the small intestinal axis, SINTAX™, to have systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems.

    Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases and EDP1908 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.

    For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.

    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 concerning the development of our product candidates and the promise and potential impact of 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 followingthe impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our businesswe 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; 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 three months ended March 31, 2021 and our other reports filed with the SEC 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.

    Contact

    Jessica Cotrone, 978-760-5622

    jcotrone@evelobio.com 



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