On February 14, 2019 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported business highlights and financial results for the fourth quarter and year ended December 31, 2018 (Press release, Agios Pharmaceuticals, FEB 14, 2019, View Source [SID1234533303]).

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In addition, Agios highlighted select 2019 corporate milestones and data presentations for its clinical development programs.

"I’m excited to join the Agios team on the heels of a transformational year for the company. During 2018, we launched our first wholly owned oncology medicine, expanded our clinical programs across both oncology and rare genetic diseases, and continued to advance our robust research pipeline," said Jackie Fouse, Ph.D. "We start 2019 with a strong foundation on which to build and with the opportunity to make a meaningful impact on patients’ lives and our business. Our objectives for this year focus on broadening the potential of our IDH inhibitors in AML and solid tumors, advancing mitapivat and AG-270 through clinical development, and remaining steadfast in our pursuit of great science."

KEY UPCOMING MILESTONES

The company plans to achieve the following key milestones in 2019:

Cancer:

Potential FDA approval of the supplemental new drug application (sNDA) for single agent TIBSOVO (ivosidenib) for the treatment of patients with newly diagnosed AML with an IDH1 mutation who are not eligible for standard therapy and subsequent launch in this indication in the U.S.
Submit an sNDA to the FDA for TIBSOVO for second line or later IDH1 mutant cholangiocarcinoma by year-end.
Initiate a registration-enabling Phase 3 study of vorasidenib (AG-881) in low-grade glioma with an IDH1 mutation by year-end.
Determine recommended dose of AG-270, a first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor, in methylthioadenosine phosphorylase (MTAP)-deleted tumors; initiate expansion arms, including a single-agent arm in a variety of MTAP-deleted cancers and a combination arm in a solid tumor in the first half of 2019.
Initiate a Phase 1 dose-escalation trial of AG-636, an inhibitor of the metabolic enzyme dihydroorotate dehydrogenase (DHODH), in lymphoma in the first half of 2019.
Rare Genetic Diseases:

Complete enrollment in two global pivotal trials for mitapivat in adults with pyruvate kinase (PK) deficiency by year-end 2019:
ACTIVATE-T: A single-arm trial of approximately 20 regularly transfused patients
ACTIVATE: A 1:1 randomized, placebo-controlled trial of 80 patients who do not receive regular transfusions
Achieve proof-of-concept for mitapivat in thalassemia in the second half of 2019.
ANTICIPATED KEY 2019 DATA PRESENTATIONS

Updated data from the ongoing Phase 1 combination trial of TIBSOVO with azacitidine in patients with newly diagnosed AML with an IDH1 mutation to be presented at the 17th International Symposium on Acute Leukemias taking place February 24-27, 2019 in Munich.
Preclinical data for AG-270 accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting taking place March 29-April 3, 2019 in Atlanta.
Data from the perioperative ‘window’ trial with TIBSOVO and vorasidenib in IDHm low-grade glioma submitted for presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31-June 4, 2019 in Chicago.
Topline data from the Phase 3 ClarIDHy study of TIBSOVO in IDH1 mutant second line or later cholangiocarcinoma to be reported in the first half and full data to be presented in the second half of 2019.
Data from the dose-escalation portion of the ongoing Phase 1 study of AG-270 in patients with MTAP-deleted tumors expected in the second half of 2019.
FOURTH QUARTER 2018 HIGHLIGHTS & RECENT PROGRESS

Submitted an sNDA to the FDA for TIBSOVO for the treatment of patients with newly diagnosed AML with an IDH1 mutation who are not eligible for standard therapy.
Submitted and received validation for a Marketing Authorization Application to the European Medicines Agency for TIBSOVO for the treatment of adult patients with R/R AML with an IDH1 mutation.
Completed enrollment in the Phase 3 ClarIDHy study of TIBSOVO in IDH1 mutant second line or later cholangiocarcinoma.
Initiated a Phase 2 proof-of-concept trial of mitapivat in thalassemia.
Received FDA clearance of an IND application for AG-636, a DHODH inhibitor.
FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS

Revenue: Total revenue for the fourth quarter of 2018 was $30.0 million, which includes $18.4 million in collaboration revenue, $9.4 million of net product revenue from U.S. sales of TIBSOVO and $2.2 million in royalty revenue from net global sales of IDHIFA under our collaboration agreement with Celgene. This compares to $9.8 million for the fourth quarter of 2017, which included $8.6 million in collaboration revenue and $1.2 million in royalty revenue from net global sales of IDHIFA. Total revenue was $94.4 million for the year ended December 31, 2018 compared to $43.0 million for the year ended December 31, 2017. The increases in revenue are primarily driven by net U.S. sales of TIBSOVO, additional collaboration revenue and royalty revenue from net U.S. sales of IDHIFA.

Cost of Sales: We began U.S. sales of TIBSOVO in the third quarter of 2018. Cost of sales were $0.7 million for the fourth quarter of 2018, and $1.4 million for the year ended December 31, 2018.

Research and Development (R&D) Expenses: R&D expenses were $93.8 million for the fourth quarter of 2018 compared to $77.2 million for the fourth quarter of 2017, and $341.3 million for the year ended December 31, 2018 compared to $292.7 million for the comparable period in 2017. The increase in R&D expense was primarily attributable to start-up costs for the mitapivat pivotal program in PK deficiency and Phase 2 study in thalassemia and IND enabling activities for AG-636, our DHODH inhibitor. R&D expense also increased as a result of ongoing research efforts across our discovery platform programs.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $31.9 million for the fourth quarter of 2018 compared to $22.7 million for the fourth quarter of 2017, and $114.1 million for the year ended December 31, 2018 compared to $71.1 million for the year ended December 31, 2017. The increase in SG&A expense was primarily attributable to costs to support commercialization of TIBSOVO and personnel costs related to increased headcount.

Net Loss: Net loss was $91.8 million for the fourth quarter of 2018 compared to $88.3 million for the fourth quarter of 2017, and $346.0 million for the year ended December 31, 2018 was compared to a net loss of $314.7 million for the year ended December 31, 2017.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of December 31, 2018 were $805.4 million compared to $567.8 million as of December 31, 2017. The change in cash was primarily driven by the net proceeds of $516.2 million from the January follow-on offering. The company expects that its cash, cash equivalents and marketable securities as of December 31, 2018, together with anticipated product and royalty revenue, anticipated interest income, and anticipated expense reimbursements under our collaboration and license agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2020.

CONFERENCE CALL INFORMATION

Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss fourth quarter and full year 2018 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 9886713. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

On February 14, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported its financial and pipeline updates for the fourth quarter and full year ended December 31, 2018 (Press release, Acorda Therapeutics, FEB 14, 2019, View Source [SID1234533302]).

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"Our top priority for 2019 is to ensure a successful launch of INBRIJA," said Ron Cohen, M.D., Acorda’s President and CEO. "Our field sales and medical teams have been meeting with Movement Disorder specialists and their office staffs to educate them about INBRIJA’s clinical profile, proper use of the inhaler and our comprehensive patient support services. We are finding strong receptiveness to this novel on-demand treatment for OFF periods."

"The approval of INBRIJA has now validated the innovative ARCUS technology, which allows relatively large doses of drug to be delivered through inhalation. We plan to apply the ARCUS platform to develop therapies for additional indications, including acute migraine, and we look forward to discussing future development milestones later this year."

Fourth Quarter 2018 Financial Results

For the quarter ended December 31, 2018, the Company reported AMPYRA net revenue of $64.2 million compared to $167.2 million for the same quarter in 2017. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Acorda has stated that there would be a significant decline in AMPYRA revenue as a result.

Research and development (R&D) expenses for the quarter ended December 31, 2018 were $27.1 million, including $1.2 million of share-based compensation compared to $35.1 million, including $2.2 million of share-based compensation for the same quarter in 2017.

Sales, general and administrative (SG&A) expenses for the quarter ended December 31, 2018 were $36.8 million, including $3.8 million of share-based compensation compared to $39.5 million, including $5.4 million of share-based compensation for the same quarter in 2017.

Benefit from income taxes for the quarter ended December 31, 2018 was $63.1 million, compared to a benefit from income taxes of $51.9 million for the same quarter in 2017.

The Company reported GAAP net income of $9.6 million for the quarter ended December 31, 2018, or $0.20 per diluted share. GAAP net loss in the same quarter of 2017 was $(171.1) million, or $(3.70) per diluted share.

Non-GAAP net income for the quarter ended December 31, 2018 was $21.5 million, or $0.45 per diluted share. Non-GAAP net income in the same quarter of 2017 was $28.5 million, or $0.61 per diluted share. This quarterly non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges and gain on sale of assets. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

Financial Results – Full Year Ended December 31, 2018

For the full year ended December 31, 2018, the Company reported Ampyra net revenue of $455.1 million compared to $543.3 million for the full year 2017. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Acorda has stated that there would be a significant decline in AMPYRA revenue as a result.

Research and development (R&D) expenses for the full year ended December 31, 2018 were $106.4 million, including $5.6 million of share-based compensation, compared to $166.1 million, including $9.7 million of share-based compensation for the full year 2017.

Sales, general and administrative (SG&A) expenses for the full year ended December 31, 2018 were $172.3 million, including $15.7 million of share-based compensation, compared to $181.6 million, including $23.1 million of share-based compensation for the full year 2017.

Benefit from income taxes for the full year ended December 31, 2018 was $13.3 million, compared to a benefit from income taxes of $28.5 million for the full year 2017.

For the full year ended December 31, 2018, the Company reported GAAP net income of $33.7 million, or $0.71 per diluted share. GAAP net loss for the full year 2017 was $(223.4) million, or $(4.86) per diluted share.

Non-GAAP net income for the full year ended December 31, 2018 was $103.4 million, or $2.18 per diluted share. Non-GAAP net income for the full year ended December 31, 2017 was $80.7 million, or $1.75 per diluted share. This full year non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges, gain on sale of assets, realized foreign currency loss and acquisition related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At December 31, 2018, the Company had cash, cash equivalents and investments of $445 million.

2019 Financial Guidance

During INBRIJA’s launch year, the Company does not expect to provide INBRIJA revenue guidance.
The Company will no longer provide revenue guidance for AMPYRA, due to the unpredictable trajectory of revenue decline given the entrance of generics.
R&D expenses for the full year 2019 are expected to be $70-$80 million and SG&A expenses for the full year 2019 are expected to be $200-$210 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."
Fourth Quarter 2018 Highlights

INBRIJA (levodopa inhalation powder)
On December 21, 2018, INBRIJA was approved by the FDA for intermittent treatment of OFF episodes in people with Parkinson’s taking carbidopa/levodopa. It is not known if INBRIJA is safe or effective in children.
The Company’s Marketing Authorization Application (MAA) for INBRIJA is currently under review by the European Medicines Agency (EMA). After the adoption of a CHMP (Committee for Medicinal Products for Human Use) opinion, the Company expects a final decision from the European Commission before the end of 2019.
In January 2019, TheLancet Neurology published results from SPAN℠-PD, the Phase 3 pivotal trial of INBRIJA.
AMPYRA (dalfampridine) Patent Appeal
In January 2019, the Federal Circuit denied Acorda’s petition for an en banc hearing in the AMPYRA patent appeal process. The Company intends to file a petition for certiorari appealing the case to the U.S. Supreme Court.
Webcast and Conference Call

The Company will host a conference call and webcast in conjunction with its fourth quarter/year end 2018 update and financial results today at 4:30 p.m. ET. To participate in the conference call, please dial (866) 393-4306 (domestic) or (734) 385-2616 (international) and reference the access code 2726179. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 5:30 p.m. ET on February 14, 2019 until 11:59 p.m. ET on March 16, 2019. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international); reference code 2726179. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net income, adjusted to exclude the items below, and has provided 2019 guidance for R&D and SG&A expenses on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of non-GAAP net income, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our outstanding convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra monetization, the asset based loan which was terminated in 2017 and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) acquisition related expenses and related foreign currency losses that pertain to a non-recurring event, (v) expenses that pertain to non-routine restructuring events, (vi) asset impairments which are non-cash charges that relate to program terminations that are not routine to the operation of the business, and (vii) gain on sale of assets that pertains to non-routine events. The Company believes its non-GAAP net income measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net income, we have provided 2019 guidance for R&D and SG&A expenses on a non-GAAP basis. Due to the forward looking nature of this information, the amount of compensation charges and benefits needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. The Company believes that these non-GAAP measures, when viewed in conjunction with our GAAP results, provide investors with a more meaningful understanding of our ongoing and projected R&D and SG&A expenses. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

On February 14, 2019 Scientific teams from NantHealth (NASDAQ: NH) and NantOmics reported that it will present two posters at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium this week (Press release, NantHealth, FEB 14, 2019, View Source;p=RssLanding&cat=news&id=2387497 [SID1234533300]). The two companies, respective leaders in molecular profiling research and genomic testing solutions, teamed together to explore the significance of RNA expression and individual biomarkers in determining why some patients do not respond to targeted cancer therapies based on DNA genomic profiling alone.

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The first poster session will provide insights on individual biomarkers obtained from liquid biopsies that may potentially improve immune checkpoint therapies for prostate cancer. The second session will feature research, conducted with experts from the UC San Diego Health Moores Cancer Center, that demonstrates the benefits of examining discrepancies between DNA alterations and RNA expression that could be the cause of treatment failure for people with metastatic kidney, bladder, and prostate cancer.

"While next generation sequencing for advanced cancers has become routine, not all patients are responding to targeted treatments based solely on DNA genomic profiling," said Sandeep "Bobby" Reddy, MD, Chief Medical Officer, NantHealth. "It is becoming clear that we must delve deeper into RNA expression, as well as identify key biomarkers, to develop effective cancer treatments and therapies."

NantHealth and NantOmics will present the following posters at this year’s Genitourinary Cancers Symposium:

Concomitant characterization of androgen receptor (AC) and immune checkpoints (ICs) in cell-free (cf) DNA and RNA from patients with metastatic castration resistant prostate cancer (mCRPC) – 11:30AM-1:00PM & 5:30PM-6:30PM, 2/14/2019, Session A, Board M21, Abstract #286
RNA sequencing in addition to next generation sequencing in advanced genitourinary cancers reveals transcriptomic silencing of DNA mutations: Implications for resistance to targeted therapeutics – 7:00AM-7:55AM & 12:30PM-2:00PM, 2/16/2019, Session C, Board E22, Abstract #583
The 2019 Genitourinary (GU) Cancers Symposium is a three-day scientific and educational meeting in San Francisco designed to meet the needs of physicians and other members of the cancer care and research community who diagnose, treat, and study GU malignancies.

On February 14. 2019 Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a clinical stage biotechnology company developing monoclonal microbials, a potential new modality of oral biologic medicines, reported financial results and provided a business update for the fourth quarter and full year 2018 (Press release, Evelo Biosciences, FEB 14, 2019, View Source [SID1234533299]).

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"Our platform opens up the potential for effective, orally delivered, safe and cost-effective medicines for improved treatments of inflammatory diseases and cancers. In 2018, we made significant progress and advanced our first three product candidates into clinical trials across multiple inflammatory diseases and cancers," said Simba Gill, Ph.D., president and chief executive officer of Evelo. "In 2019, we expect to advance our oncology clinical trials and announce clinical data from our ongoing inflammatory disease clinical trials which may signal the potential for monoclonal microbials as a broadly applicable new modality of medicines."

2018 and Recent Business Highlights:

Inflammation

April 2018 – Evelo initiated a placebo-controlled Phase 1b clinical trial of EDP1066 in healthy volunteers and patients with atopic dermatitis or psoriasis. Following completion of each of the three dose-ascending healthy volunteer cohorts, data was reviewed by the trial’s safety review committee and the trial proceeded as planned into cohorts of patients with atopic dermatitis or psoriasis

November 2018 – Evelo initiated a placebo-controlled Phase 1b clinical trial of EDP1815 in healthy volunteers and patients with atopic dermatitis or psoriasis

Oncology

November 2018 – Entered into clinical collaboration with Merck to evaluate EDP1503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in multiple cancer indications

December 2018 – Evelo initiated an open-label Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA in microsatellite stable colorectal cancer, triple-negative breast cancer, and patients with other tumor types that have relapsed on prior PD-1/L1 inhibitor treatment

January 2019 – The University of Chicago initiated an open-label Phase 2a clinical trial of EDP1503 in combination with KEYTRUDA in naïve melanoma patients and melanoma patients that have relapsed on prior PD-1/L1 inhibitor treatment

Non-Replicating Monoclonal Microbials

Preclinical studies have shown that non-replicating monoclonal microbials, which have been treated to prevent growth and division, maintain activity, opening up the potential to develop non-replicating monoclonal microbial clinical candidates

Monoclonal microbial activity is likely driven by recognition of structural motifs by immune cells in the small intestine and is not dependent on engraftment or colonization

Nominated EDP1867 as a preclinical monoclonal microbial candidate for inflammatory diseases. EDP1867 is the first monoclonal microbial specifically developed as a non-replicating product candidate in Evelo’s pipeline

Anticipated 2019 Clinical Milestones

Initial clinical data from the ongoing Phase 1b clinical trial of EDP1066 in healthy volunteers and patients with psoriasis or atopic dermatitis in the second quarter of 2019

Initiation of an immuno-pharmacology clinical study in healthy volunteers with EDP1066 in 1H 2019, designed to explore additional doses and formulations ahead of potential later stage trials.

Initial clinical data from the ongoing Phase 1b clinical trial of EDP1815 in healthy volunteers and patients with psoriasis or atopic dermatitis in the second half of 2019

Initiation of clinical trials with EDP1066 and EDP1815 in additional inflammatory disease indications in the second half of 2019

Fourth Quarter and Full Year 2018 Financial Results

Cash Position: As of December 31, 2018, cash, cash equivalents and investments were $147.9 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 convertible 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 full year 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 $11.3 million for the three months ended December 31, 2018 and $39.9 million for the full year ended December 31, 2018, compared to $6.1 million for the three months ended December 31, 2017 and $20.0 million for the full year ended December 31, 2017. The increase of $19.9 million for 2018 was due primarily to increases in costs related to Evelo’s inflammation and oncology clinical development programs, and gut-body network platform expenses, as well as increased personnel costs.

General and Administrative Expenses: G&A expenses were $4.7 million for the three months ended December 31, 2018 and $18.2 million for the full year ended December 31, 2018, compared to $2.0 million for the three months ended December 31, 2017 and $7.6 million for the full year ended December 31, 2017. The increase of $10.6 million for 2018 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 $15.4 million for the three months ended December 31, 2018 and $60.9 million for the full year ended December 31, 2018, or $(0.49) and $(2.78) per basic and diluted share, respectively, as compared to a net loss attributable to common stockholders of $9.9 million for the three months ended December 31, 2017 and $34.1 million for the full year ended December 31, 2017,or $(2.57) and $(9.10) per basic and diluted share, respectively.

Conference Call
Evelo will host a conference call and webcast today at 8:30a.m. ET. To access the call please dial (866) 795-3242 (domestic) and (409) 937-8909 (international) and provide the passcode 7986199. A live webcast of the call will be available on the Investors sections of the Evelo website at www.evelobio.com. The archived webcast will be available approximately two hours after the conference call and will be available for 30 days following the call.

On February 14, 2019 Minomic International Ltd is reported the company has executed an agreement with Cirrus Dx, a CLIA Certified "High Complexity" Laboratory, enabling US clinicians and patients early access to the company’s novel test for Prostate Cancer (Press release, Minomic, FEB 14, 2019, View Source [SID1234533296]). The agreement allows Cirrus Dx to perform MiCheck as a Laboratory Developed Test (LDT) in the company’s Rockville MD based laboratory once internal validation is completed. Finalising this agreement completes an important step in commercialising MiCheck in the world’s largest healthcare market.

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Dr Brad Walsh, Minomic’s CEO, noted "Being able to offer MiCheck as an LDT through our partnership with Cirrus Dx will provide the Company with three important outcomes, ‘Real World Data’ which can be used in subsequent FDA approval submissions, validation of MiCheck and its clinical utility and finally, royalty revenues. Our thanks to the Cirrus Dx team for making this possible with special acknowledgement for the hard work and vision provided by Cirrus’ Kyle Armantrout. We are very excited to be working with them as they continue to build their franchise in the urological testing space".

William M. Nelson, MD, Cirrus Dx’s President said "The ability of MiCheck to improve the diagnosis of Prostate Cancer and, in particular, reduce the number of unnecessary biopsies being performed is a game-changer and we look forward to working with Minomic to bring this vital improvement into the US market".

Minomic and Cirrus expect the required internal validation studies to be completed by the end of Quarter 1, 2019. Urologists and their patients in the US will have access to the MiCheck test shortly thereafter. A suitable reimbursement code has been identified and both companies believe that appropriate reimbursement will be available. Commercial details of the agreement will remain confidential.