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Press Release: Evelo Biosciences Announces Fourth Quarter and Full Year 2020 Financial Results and Business Highlights

Press Release: Evelo Biosciences Announces Fourth Quarter and Full Year 2020 Financial Results and Business Highlights

新闻稿:Evelo Biosciences宣布2020年第四季度和全年财务业绩和业务亮点
Dow Jones Newswires ·  2021/03/09 20:00

Press Release: Evelo Biosciences Announces Fourth Quarter and Full Year 2020 Financial Results and Business Highlights

新闻稿:Evelo Biosciences宣布2020年第四季度和全年财务业绩和业务亮点

Evelo Biosciences Announces Fourth Quarter and Full Year 2020 Financial Results and Business Highlights

Evelo生物科学公司宣布2020年第四季度和全年的财务业绩和业务亮点

--Announced new positive data in human experimental model of inflammation of EDP1815--

--在EDP1815的人体实验炎症模型中公布了新的阳性数据--

--Completed enrollment in Phase 2b dose-ranging trial for EDP1815 in psoriasis; full data set accelerated and now expected in 3Q 2021--

--EDP1815治疗牛皮癣的2b期剂量范围试验已完成登记;全数据集加速,目前预计在2021年第三季度--

--Initiated Phase 1b clinical trial of EDP1867 in atopic dermatitis; data expected in 4Q 2021--

--启动EDP1867治疗特应性皮炎的1b期临床试验;数据预计将于2021年第四季度公布--

--Up to 8 clinical data readouts expected over next 18 months--

--未来18个月预计最多8次临床数据读数--

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

-管理层将于上午8:30主持电话会议。外星人--

CAMBRIDGE, Mass., March 09, 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 fourth quarter and full year 2020.

马萨诸塞州坎布里奇,2021年3月9日(环球网)--临床阶段生物技术公司Evelo Biosciences,Inc.(纳斯达克市场代码:EVLO)今天公布了2020年第四季度和全年的财务业绩和业务亮点。Evelo Biosciences公司是一家临床阶段的生物技术公司,正在开发一种新的口服给药方式。

"Building on a series of positive clinical data announcements and strong progress in 2020, we are pleased to begin 2021 by announcing a further positive clinical data readout with EDP1815. We have now shown positive clinical data with EDP1815 in five separate cohorts across psoriasis, atopic dermatitis, and a human experimental model of inflammation. EDP1815's observed profile of broad inflammation resolving effects and tolerability is highly differentiated and supports the potential of EDP1815 as a foundational treatment for all stages of inflammatory disease," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "The new EDP1815 data we are reporting today is from a healthy volunteer experimental model of inflammation. This study showed that an increase in the concentration of drug in a capsule resulted in enhanced effect for the same overall dose. We are also pleased with the accelerated recruitment of the Phase 2b trial of EDP1815 in psoriasis, and we will now report top-line data for the full cohort of patients in the third quarter of this year."

SimP1815说:“在2020年一系列积极的临床数据公告和强劲进展的基础上,我们很高兴以EDP1815的进一步积极的临床数据读数开始2021年的开始。我们现在已经在牛皮癣、特应性皮炎和人类炎症实验模型的五个不同的队列中显示了EDP1815的阳性临床数据。EDP1815在广泛的消炎效果和耐受性方面的观察概况是高度不同的,支持EDP1815作为所有阶段炎症性疾病的基础治疗的潜力。”我们今天报告的新的EDP1815数据来自一种健康的志愿者炎症实验模型。这项研究表明,胶囊中药物浓度的增加导致相同总剂量的效果增强。我们还对EDP1815治疗牛皮癣的2b期试验的加速招募感到高兴,我们现在将报告今年第三季度全部患者的顶级数据。“

Dr. Gill continued, "The results we have observed with EDP1815 provide evidence for the entire SINTAX(TM) platform and support the potential of our investigational medicines to control systemic inflammation and immunity. EDP1815 and dermatological diseases are only the beginning. In February, we initiated the first clinical trial of our next anti-inflammatory candidate, EDP1867. We are progressing our two extracellular vesicle candidates, EDP2939 for inflammatory diseases and EDP1908 for oncology. In addition, we have strengthened our balance sheet with $88 million in net proceeds from recent sales of our common stock and have expanded our team with the appointments of Jonathan Zung, Ph.D., as Chief Development Officer, and John Hohneker, M.D., to our Board of Directors. We now have the resources and team in place to advance our broad portfolio to later-stage development."

吉尔博士继续说:“我们用EDP1815观察到的结果为整个SINTAX(TM)平台提供了证据,并支持我们的研究药物控制全身炎症和免疫的潜力。EDP1815和皮肤病只是开始。今年2月,我们启动了下一个抗炎候选药物EDP1867的首次临床试验。我们正在研究两种胞外囊泡候选药物,用于炎症性疾病的EDP2939和用于肿瘤学的EDP1908。此外,我们通过最近出售普通股获得的8800万美元净收益加强了我们的资产负债表,并通过任命乔纳森·宗(Jonathan Zung)博士和约翰·霍内克(John Hohneker)医学博士进入我们的董事会,扩大了我们的团队。我们现在拥有资源和团队,可以将我们广泛的产品组合推进到后期开发。“

Fourth Quarter/Full Year 2020 Highlights and Recent Progress

2020年第四季度/全年亮点和最新进展

EDP1815 in Human Experimental Model of Inflammation

EDP1815在人实验性炎症模型中的作用

-- Evelo today announced positive data from a healthy volunteer experimental model of inflammation with EDP1815.

--Evelo公司今天宣布了使用EDP1815的一种健康的志愿者炎症实验模型的阳性数据。

-- A total of 32 healthy volunteers were dosed daily for 28 days with either of two concentrations of EDP1815, or placebo.

-共有32名健康志愿者在28天内每天服用两种浓度的EDP1815中的任何一种,或安慰剂。

-- The study was designed to investigate the relative effectiveness of two different concentrations of EDP1815 in capsules.

--这项研究旨在调查胶囊中两种不同浓度的EDP1815的相对有效性。

-- The increased concentration of drug results from improvements made in the commercial-scale manufacturing process (referred to as A2). This is the same active drug at four times the concentration compared to a prior manufacturing process (referred to as A').

-药物浓度的增加是商业规模制造工艺(简称A2)改进的结果。与先前的制造工艺(称为A‘)相比,这是相同活性药物的浓度的四倍。

-- Healthy volunteers were immunized with the same antigen used in preclinical inflammation experiments. After 28 days of daily oral treatment with EDP1815 or placebo, subjects were given a skin challenge with the antigen which causes measurable skin inflammation a day later. 12 subjects were given A' EDP1815. Another 12 subjects were given the higher concentration A2. The 8 subjects who received a placebo were divided between the two treatment groups.

-健康志愿者用临床前炎症实验中使用的相同抗原进行免疫。在每天口服EDP1815或安慰剂28天后,受试者接受抗原的皮肤挑战,一天后这种抗原会引起可测量的皮肤炎症。12名受试者接受A‘EDP1815治疗。另12名受试者给予较高浓度的A2。接受安慰剂治疗的8名受试者被分成两组。

-- As shown in the figure below, the higher concentration A2, given in fewer capsules, resulted in numerically superior reductions across the full range of skin evaluation scores compared to A' and to placebo. A2 and A' were given at the same total daily dose of drug.

--如下图所示,与A‘和安慰剂相比,在更少的胶囊中给予更高浓度的A2,在所有的皮肤评估分数上都会导致数值上更好的降低。A2和A‘按相同的每日总剂量给药。

-- These results are consistent with preclinical data showing that increased drug concentration resulted in increased effects.

--这些结果与临床前数据一致,这些数据表明药物浓度越高,效果越好。

-- This is a key advancement in Evelo's understanding of how to get even more benefit from SINTAX medicine candidates.

--这是Evelo公司理解如何从SINTAX候选药物中获得更多好处的关键进展。

A figure accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/cce3303e-0666-4723-b74f-1ca2c6efc180

本公告附带的数字可在以下网址查阅:https://www.globenewswire.com/NewsRoom/AttachmentNg/cce3303e-0666-4723-b74f-1ca2c6efc180

-- Based on these data, Evelo is expanding its ongoing Phase 1b clinical trial to include additional cohorts evaluating the higher concentration A2 in both tablet and capsule formulations. Results from the Phase 1b trial and ongoing Phase 2b trial together will position the Company to go forward into Phase 3 trials with an optimized dose and formulation of EDP1815 which may further improve on the positive results already seen.

-基于这些数据,Evelo公司正在扩大其正在进行的1b期临床试验,以包括评估片剂和胶囊配方中较高浓度A2的更多队列。1b期试验和正在进行的2b期试验的结果将使该公司在EDP1815的最佳剂量和配方下进入第三阶段试验,这可能会在已经看到的积极结果的基础上进一步改善。

EDP1815 in Psoriasis

EDP1815在银屑病中的作用

-- Evelo has completed enrollment in its ongoing Phase 2b dose-ranging trial using A' EDP1815. Given accelerated recruitment, the Company now plans to report top-line data for all patients in the study in the third quarter of this year in place of an interim data readout on the first 113 patients.

--Evelo公司已经完成了使用A‘EDP1815的正在进行的2b阶段剂量范围试验的登记。鉴于招募速度加快,该公司现在计划在今年第三季度报告研究中所有患者的一线数据,而不是第一批113名患者的临时数据读数。

EDP1815 in Atopic Dermatitis

EDP1815在特应性皮炎中的应用

-- In December and January, Evelo announced positive clinical data from a cohort of patients with mild and moderate atopic dermatitis in its Phase 1b clinical trial. -- In addition to being well tolerated with no treatment-related adverse events of moderate or severe intensity and no serious adverse events, the data showed consistent improvements in percentage change from baseline compared to placebo for Eczema Area and Severity Index (EASI), Investigator's Global Assessment and Body Surface Area (IGA*BSA) and SCORing Atopic Dermatitis (SCORAD). Treatment with EDP1815 also resulted in clinically meaningful improvement in the patient-reported outcomes of Dermatology Life Quality Index (DLQI) and Patient-Oriented Eczema Measure (POEM).

--12月和1月,Evelo公司在其1b期临床试验中宣布了一组轻度和中度过敏性皮炎患者的阳性临床数据。--除了耐受性良好,没有中度或重度的与治疗相关的不良事件,也没有严重的不良事件,数据显示湿疹面积和严重指数(EASI)、调查者的全球评估和身体表面积(IGA*BSA)以及特应性皮炎评分(SCORAD)与安慰剂相比的百分比变化与基线相比持续改善。EDP1815治疗还导致患者报告的皮肤病生活质量指数(DLQI)和以患者为导向的湿疹测量(POEM)的结果在临床上有意义的改善。

EDP1867 in Atopic Dermatitis

EDP1867在特应性皮炎中的应用

-- In February, Evelo initiated a Phase 1b trial of EDP1867 in healthy volunteers and patients with moderate atopic dermatitis.

--2月份,Evelo公司在健康志愿者和中度过敏性皮炎患者身上启动了EDP1867的1b期试验。

EDP1908 in Oncology

EDP1908肿瘤学

-- In November, Evelo presented preclinical data for EDP1908 at the Society for Immunotherapy of Cancer's (SITC) 35th Anniversary Annual Meeting. The data showed that orally administered EDP1908, an extracellular vesicle, resulted in superior tumor growth control versus either the parental microbial strain or anti-PD-1 therapy, with an observed dose-dependent reduction of tumor growth. The observed effects were comparable to those reported in the literature for intratumorally administered immune stimulators. Evelo subsequently announced the decision to prioritize EDP1908 as its lead clinical candidate in oncology.

--11月,Evelo在癌症免疫治疗学会(SITC)35周年年会上公布了EDP1908的临床前数据。数据显示,口服EDP1908(一种细胞外囊泡)比亲本微生物菌株或抗PD-1治疗的肿瘤生长控制效果更好,观察到肿瘤生长随剂量的减少而减少。观察到的效果与文献报道的瘤内注射免疫刺激剂的效果相当。Evelo随后宣布决定优先考虑EDP1908作为其肿瘤学的主要临床候选药物。

Business Highlights

业务亮点

-- In December 2020, Evelo announced the appointment of Jonathan Zung, Ph.D., as Chief Development Officer and a member of the Evelo Executive Team. Dr. Zung brings more than 25 years of global pharmaceutical development and commercialization experience to Evelo. -- In February 2021, Evelo closed an underwritten public offering of shares of its common stock at a public offering price of $15.00 per share, and a private placement of shares of its common stock at an offering price of $15.00 per share, resulting in gross proceeds of approximately $85.1 million, before underwriting discounts and commissions. -- In February 2021, Evelo announced the appointment of John A. Hohneker, M.D., to its Board of Directors.

--2020年12月,Evelo宣布任命Jonathan Zung博士为首席开发官和Evelo执行团队成员。Zung博士为Evelo公司带来了超过25年的全球制药开发和商业化经验。-2021年2月,Evelo完成了以每股15.00美元的公开发行价承销的普通股公开发行和以每股15.00美元的发行价私募普通股的私募,在承销折扣和佣金之前,总收益约为8510万美元。--2021年2月,Evelo公司宣布任命医学博士约翰·A·霍内克为董事会成员。

Upcoming Key Milestones

即将到来的关键里程碑

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

EDP1815--牛皮癣;所有数据预计将于2021年第三季度报告

-- Data from Phase 1b cohorts with A2 tablets and A2 capsules -- Full data from Phase 2b dose-ranging trial

--来自使用A2片剂和A2胶囊的1b期队列的数据--来自2b期剂量范围试验的全部数据

EDP1815 -- Atopic Dermatitis

EDP1815--特应性皮炎

-- Subject to regulatory approval, initiation of Phase 2 trial in 3Q 2021

-待监管部门批准,2021年第三季度启动第二阶段试验

EDP1815 -- COVID-19

EDP1815--新冠肺炎

-- Data from Phase 2 trial with Rutgers University in 2Q 2021 -- Interim safety and futility analysis from Phase 2/3 TACTIC-E trial in 2Q 2021

--2021年下半年与罗格斯大学进行的第2期试验的数据--2021年下半年第2/3期TARY-E试验的临时安全性和有效性分析

EDP1867 -- Atopic Dermatitis

EDP1867--特应性皮炎

-- Interim data from Phase 1b trial expected in 4Q 2021

-预计2021年第四季度1b阶段试验的中期数据

EDP2939 -- Inflammation

EDP2939--炎症

-- Initiation of clinical development in 2022

-2022年启动临床开发

EDP1908 -- Oncology

EDP1908--肿瘤学

-- Initiation of clinical development in 2022

-2022年启动临床开发

Fourth Quarter and Full Year 2020 Financial Results

2020年第四季度和全年财务业绩

-- Cash Position: As of December 31, 2020, cash and cash equivalents were $68.9 million, as compared to cash and cash equivalents of $77.8 million as of December 31, 2019. This decrease was primarily due to cash used in operating activities, partially offset by $48.4 million in net proceeds from the Company's June 2020 follow-on offering of common stock and draw down of an additional $10 million under its existing debt facility in July 2020. During the first quarter of 2021, the Company raised net proceeds of $82.2 million from the issuance of common stock exclusive of certain other fees payable by the Company. -- Research and Development Expenses: R&D expenses were $22.1 million for the three months ended December 31, 2020 and $69.6 million for the full year ended December 31, 2020, compared to $16.4 million for the three months ended December 31, 2019, and $63.1 million for the full year ended December 31, 2019. The increase of $6.5 million year over year was primarily due to increased costs related to Evelo's inflammation clinical development programs, clinical development and technical operations headcount growth and platform investment, partially offset by lower oncology spend.

-现金状况:截至2020年12月31日,现金和现金等价物为6890万美元,而截至2019年12月31日的现金和现金等价物为7780万美元。这一减少主要是由于经营活动中使用的现金,但被该公司2020年6月后续发行普通股的4840万美元净收益部分抵消,并在2020年7月根据其现有债务安排额外提取1000万美元。2021年第一季度,公司通过发行普通股筹集了8220万美元的净收益,这还不包括公司应支付的某些其他费用。-研发费用:截至2020年12月31日的三个月和截至2020年12月31日的全年的研发费用分别为2210万美元和6960万美元,而截至2019年12月31日的三个月和截至2019年12月31日的全年的研发费用分别为1640万美元和6310万美元。650万美元的同比增长主要是由于与Evelo的炎症临床开发计划、临床开发和技术运营人员增长以及平台投资相关的成本增加,但部分被肿瘤学支出的减少所抵消。

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March 09, 2021 07:00 ET (12:00 GMT)

2021年3月09日美国东部时间07:00(格林尼治标准时间12:00)

译文内容由第三方软件翻译。


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