On May 5, 2020 NuCana plc (NASDAQ: NCNA) reported it has re-commenced enrollment of new patients in NuTide:121, its ongoing global Phase III study of Acelarin (NUC-1031) plus cisplatin in patients with biliary tract cancer (Press release, Nucana BioPharmaceuticals, MAY 5, 2020, View Source [SID1234557033]). The re-opening of NuTide:121 has begun in certain geographies, including Australia, Canada, South Korea, Taiwan, Ukraine and the United Kingdom. NuCana will work closely with the clinicians involved in NuTide:121 to re-open all of the clinical sites to new patient enrollment as soon as practicable.

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"We will continue to monitor the impact of the COVID-19 pandemic, but re-opening this study is important for patients with biliary tract cancer who need treatment" said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. Mr. Griffith added "The COVID-19 pandemic has had a dramatic impact on the global healthcare delivery system and on cancer patient care, and it is vital that the development of new cancer treatments, such as Acelarin, is resumed as quickly as possible.

NuTide:121 is a global, multi-center, randomized Phase III study of Acelarin, NuCana’s ProTide transformation of gemcitabine, that will enroll up to 828 patients in approximately 120 sites across North America, Europe, Asia and Australia. Patients are being randomized 1:1 and treated with either a combination of Acelarin (725 mg/m2) plus cisplatin (25 mg/m2) or the current standard of care regimen, gemcitabine (1,000 mg/m2) plus cisplatin (25 mg/m2).

On May 5, 2020 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the three months ended March 31, 2020 (Press release, Quanterix, MAY 5, 2020, View Source [SID1234557032]).

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"Q1 2020 was yet another strong quarter for Quanterix underscored by strong execution and revenue growth, particularly given the COVID-19 pandemic," said Kevin Hrusovsky, President, Chairman and Chief Executive Officer, Quanterix. "We are making continuous advances in many neurology, immunity and COVID-19 applications. We are also utilizing our Accelerator Laboratory to run trials and studies for customers experiencing disruptions in their laboratories. Despite the present near-term challenges, we remain positive and committed to the unprecedented market opportunity."

First Quarter 2020 Financial Highlights

Key financial results for the first quarter of 2020 are shown below:

·Q1 revenue was $15.7M versus prior year Q1 of $12.3M, an increase of 27%;
·Q1 product revenue was $9.8M versus prior year Q1 of $9.5M, an increase of 3%;
·Q1 service and other revenue was $5.8M versus prior year Q1 of $2.8M, an increase of 107%;
·Q1 GAAP gross margin was 43.3% versus prior year Q1 of 48.7%; Q1 non-GAAP gross margin was 48.5% versus prior year Q1 of 48.7%. Q1 2020 gross margin includes 200 bps of adverse impact from our successful HD-X trade-in program.

For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" and "Reconciliation of Non-GAAP Financials" below.

First Quarter 2020 Business Highlights

·Early in the progression of COVID-19, we took aggressive steps to protect our employees and their families, while rapidly implementing a resilience plan to maintain our operations and support our global customer base. As a result, we have successfully maintained our operations and have expanded our Accelerator capacity to support customer disruptions and sustain clinical trials.
·To support the global public health response, we are engaging closely with researchers and KOLs around the world. We have implemented a set of important and differentiated tools for COVID-19 investigators to immediately deploy to study disease progression, life-threatening cytokine release syndrome and patient-treatment response. Researchers are leveraging Simoa’s extreme sensitivity and specificity of cytokine panels to measure levels and profiles in non-critical and critical COVID-19 patients to identify ways to combat the virus and help prevent cytokine storm. We are also working toward developing a SARS-COV-2 quantitative IgG assay, developing an antigen early detection assay in blood and a high-definition SARS-COV-2 assay to enable research pursuits.

·Sponsored a webinar with Powering Precision Health, "Highly Sensitive and Accurate Multiplex Test to Monitor the Immune Response to Viral Infection," which featured insights from several researchers actively treating COVID-19 patients in Europe and China. Specifically, the webinar discussed capabilities to conduct highly sensitive and accurate multiplexed tests for cytokines and chemokines in serum and plasma.
·Reinforced the growing utility of Simoa in neurology research, including results published in JAMA Network Open, demonstrating the promise of blood biomarkers to serve as clinical tools for objectively identifying and monitoring sports-related concussions (SRCs) and mild traumatic brain injuries (mTBIs), marking a notable advance in the pursuit of a concussion diagnostic test. Conducted as part of the CARE Consortium, and funded by the US Department of Defense (DOD) and the National Collegiate Athletic Association (NCAA), the study used Simoa to evaluate a total of 504 collegiate athletes in what is considered the largest athletic cohort for a biomarker concussion study to date.
·Quanterix’ Simoa technology was highlighted in 53 new publications, bringing total Simoa-specific inclusions to over 789 publications.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on May 5, 2020, at 4:30 p.m., EDT to discuss the Company’s financial results and business outlook. To access this call, dial (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 4994882.

A live webcast will be accessible on the Investors section of Quanterix’ website: View Source The webcast will be available on the Company’s website following completion of the call.

On May 5, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL and peripheral-blood lymphocyte, PBL), reported first quarter 2020 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, MAY 5, 2020, View Source [SID1234557031]).

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"We continue making strong progress toward commercializing Iovance TIL for melanoma and cervical cancer indications," said Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. "While COVID-19 has impacted healthcare systems globally, we have been able to continue our key business operations due to dedication from our employees and through close collaboration with our clinical sites and other business partners. Cancer patients are still in critical need of access to therapy and a one-time treatment may offer an attractive therapeutic option to patients and treating physicians. With the first potential cell therapy in solid tumors and a broad TIL platform, Iovance remains well-positioned to become the leader in development, manufacturing, and commercialization of TIL cell therapy for cancer."

First Quarter 2020 Updates

Clinical:

·Melanoma: the last patient in the pivotal Cohort 4 of C-144-01 melanoma study was dosed in January 2020. The enrollment of this cohort was completed approximately three months ahead of schedule with over-enrollment due to increased demand for participation.
·Cervical: enrollment in the cervical study C-145-04 continues and completion of enrollment in the pivotal program is on track for approximately mid-2020.

Regulatory:

·Iovance continues preparing for submission of a Biologics License Application (BLA) in late 2020 through data compilation as well as internal readiness activities.

Manufacturing:

·Manufacturing at all manufacturing organizations continues as planned for ongoing clinical studies.
·Construction of the Iovance manufacturing facility at the Navy Yard in Philadelphia continues with initiation of the build of clean rooms in April 2020, ahead of schedule.

Corporate:

·Iovance continues to build a strong team with approximately 190 employees across multiple locations and an experienced commercial team in place preparing for launch of lifileucel.
·Iovance has been granted or allowed a total of 12 patents for compositions and methods of treatment in using Iovance TIL in a board range of cancers related to its 22-day second generation (Gen 2) manufacturing process.

Clinical Data Presentations:

·Oral presentation of updated data from Cohort 2 in the C-144-01 trial in metastatic melanoma at upcoming ASCO (Free ASCO Whitepaper) 2020: the abstract #10006 is titled "Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies." The virtual scientific program of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) will be held May 29-31, 2020.
·H. Lee Moffit Cancer Center’s TIL data from Phase 1 lung cancer study presented at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I: Moffit’s presentation demonstrated the potential clinical benefit for TIL in non-small cell lung cancer (NSCLC), including two durable complete responses lasting beyond 12 months, in a Phase 1 study supported by Iovance Biotherapeutics, a Stand Up To Cancer Catalyst grant, and other partners.

First Quarter 2020 Financial Results

Net loss for the first quarter ended March 31, 2020, was $69.6 million, or $0.55 per share, compared to a net loss of $37.0 million, or $0.30 per share, for the first quarter ended March 31, 2019.

Research and development expenses were $57.0 million for the first quarter ended March 31, 2020, an increase of $26.1 million compared to $30.9 million for the first quarter ended March 31, 2019. The increase in first quarter 2020 over the prior year period was primarily attributable to an increase in costs associated with the license to the IOV-3001 IL-2 analog from Novartis, clinical trials due to higher enrollment, growth of the internal research and development team, and increased manufacturing activities.

General and administrative expenses were $13.9 million for the first quarter 2020, an increase of $4.8 million compared to $9.1 million for the first quarter 2019. The increase in first quarter 2020 over the prior year period was primarily attributable to growth of the internal general and administrative team, higher stock-based compensation expenses, as well as higher legal costs.

At March 31, 2020, the company held $251.2 million in cash, cash equivalents, short-term investments and restricted cash compared to $312.5 million at December 31, 2019. The first quarter 2020 spend included upfront license payments and the purchase of clinical materials.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss the first quarter 2020 financial results and to provide a corporate update. The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 4564469. The live webcast can be accessed in the Investors section of the company’s website at View Source The archived webcast will be available for a year in the Investors section at www.iovance.com.

On May 5, 2020 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of Quality, Affordable Self-Care Products, reported that its Board of Directors declared a quarterly dividend of $0.225 per share, payable on June 16, 2020 to shareholders of record on May 29, 2020 (Press release, Perrigo Company, MAY 5, 2020, View Source [SID1234557030]).

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On May 5, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported financial results for its fiscal third-quarter 2020 and provided an update on recent business activity (Press release, Myriad Genetics, MAY 5, 2020, View Source [SID1234557029]). On April 8, 2020 Myriad withdrew its annual financial guidance and is not issuing new financial guidance due to the business uncertainty created by the recent global COVID-19 pandemic.

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"We saw several signs of improved business progress in the fiscal third-quarter and test volumes were trending above expectations prior to the initiation of social distancing policies in mid-March. These policies have led to unprecedented delays in elective testing for the lab industry and negatively impacted all aspects of our business," said R. Bryan Riggsbee, interim president and CEO and CFO, Myriad Genetics. "I am very proud of how the company has pulled together to respond to the current crisis. Looking forward, a number of pending catalysts, such as the potential for a final Medicare Local Coverage Determination (LCD) for GeneSight covering primary care, position us exceptionally well when global testing demand returns to more normalized levels."

Recent Business Updates

Global Coronavirus Pandemic

The global pandemic significantly impacted elective procedure and testing demand. In April 2020, Myriad has seen volumes for the company’s tests such as hereditary cancer, GeneSight, and Vectra down approximately 70 to 75 percent, volumes for cancer tests such as Prolaris, EndoPredict, and myChoice CDx down 40 to 45 percent, and volumes for prenatal testing down 20 to 25 percent.

Myriad has implemented policies to promote employee and customer safety, while preserving business continuity. In mid-March the company restricted all field sales personnel from in-office visits and moved to virtual marketing. Additionally, the company implemented initiatives in its laboratories to promote continuity of lab operations across all product lines.

The company has initiated cost-saving initiatives to mitigate financial losses through the period of social distancing. The company anticipates a significant reduction in commission, marketing, travel and mileage expenses based upon its changes in sales policies. Additionally, Myriad initiated temporary furloughs for employees in areas such as operations, billing and customer service based upon lower test demand and has implemented temporary salary reductions to senior executive and Board of Director pay.

Myriad has worked with the company’s creditors to amend its credit facility. The amended credit facility provides relief from certain financial covenants through March 31, 2021.

Hereditary Cancer

Hereditary cancer revenue in the quarter was $85.2 million. Test volumes declined four percent and pricing declined by 25 percent on a year-over-year basis. Prior to the onset of social distancing policies in March, test volumes were growing in the mid-single digits on a year-over-year basis.

Received reimbursement and launched the BRACAnalysis Diagnostic System in Japan to help physicians determine which people affected with breast and ovarian cancer have Hereditary Breast and Ovarian Cancer (HBOC) syndrome and qualify for additional diagnostic and medical management. BRACAnalysis previously was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in November 2019 for this indication.

GeneSight

GeneSight revenue in the quarter was $20.4 million. Test volumes declined by 33 percent year-over-year and average selling prices increased two percent year-over-year.

Published a GeneSight meta-analysis covering four major clinical studies and 1,556

patients. Across the patient populations, patients who received guided care with GeneSight saw a 43 percent improvement in symptoms relative to treatment as usual, a 40 percent improvement in response rates, and a 49 percent improvement in remission rates, all of which were highly statistically significant.

Prenatal

Prenatal revenue in the quarter was $20.3 million. Test volumes were flat on a year-over-year basis but increased 12 percent sequentially and test average selling prices declined 34 percent year-over-year.

Vectra

Vectra revenue in the quarter was $10.5 million. Test volumes declined six percent year-over-year and average selling prices declined by two percent.

Prolaris

Prolaris revenue in the quarter was $6.8 million. Test volumes increased year-over-year by nine percent and test average selling prices declined 10 percent.

Presented data at the ASCO (Free ASCO Whitepaper) Genitourinary Cancer symposium demonstrating the ability of Prolaris to predict which unfavorable intermediate and high-risk prostate cancer patients will respond to multi-modality therapy and which patients can safely avoid the additional morbidity associated with increased treatment. In the study of 718 men, patients who were above the risk threshold saw a statistically significant reduction in metastases when receiving multi-modality therapy.

The National Comprehensive Cancer Network updated their professional guidelines to include Prolaris across all major risk categories.

The European Urology Association Guidelines for 2020 recommend biomarker testing, including Prolaris for prostate cancer patients where there is clear clinical actionability.

Companion Diagnostics

Received U.S. Food and Drug Administration (FDA) approval for BRACAnalysis CDx as a companion diagnostic test for patients with metastatic pancreatic cancer seeking treatment with Lynparza (olaparib).

Submitted a supplementary premarket approval (sPMA) application to FDA for its myChoice CDx test to help identify women with advanced ovarian cancer who are potential candidates for first-line maintenance therapy with Lynparza in combination with bevacizumab.

Submitted a sPMA application to the FDA for its BRACAnalysis CDx test as a companion diagnostic to AstraZeneca’s and Merck’s PARP inhibitor Lynparza for men with metastatic

castration-resistant prostate cancer.

Other

Myriad completed the sale of its German subsidiary, Privatklinik Dr. Robert Schindlbeck GmbH & Co. KG, and received cash proceeds of approximately $23 million from the sale.

Recorded a $98.4 million charge including $80.7 million due to a goodwill write down associated with the Crescendo acquisition and $17.7 million due to the write down of in-process R&D associated with the Sividon acquisition.

Conference Call and Webcast

A conference call will be held today, Tuesday, May 5, 2020, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal third-quarter and business developments. The dial-in number for domestic callers is 1-800-272-6255. International callers may dial 1-303-223-4384. All callers will be asked to reference reservation number 21960364. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will be available through a live webcast at www.myriad.com.