On May 4, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $402.1 million for the first quarter ended March 31, 2021, compared to $347.8 million for the same period of 2020 (Press release, Exact Sciences, MAY 4, 2021, View Source [SID1234579089]).

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"The first quarter demonstrated Exact Sciences is well-positioned for growth today and into the future," said Kevin Conroy, Chairman and CEO. "Our Cologuard and Oncotype tests help people in need of answers, including those who have been vulnerable during the pandemic. We plan to bring additional solutions to patients throughout the course of their diagnosis and treatment."

First Quarter 2021 Financial Results

For the three-month period ended March 31, 2021, as compared to the same period of 2020 (where applicable):

Total revenue was $402.1 million, an increase of 16 percent
Screening revenue was $240.3 million, an increase of 10 percent
Precision Oncology revenue was $129.4 million, an increase of 1 percent
COVID-19 testing revenue was $32.3 million
Gross margin including amortization of acquired intangible assets was 68%, and non-GAAP gross margin excluding amortization of acquired intangible assets was 73%
Income tax benefit was $242.8 million due to a change in the deferred tax asset valuation allowance resulting from the Thrive combination
Net loss was $31.2 million, or $0.18 per share, compared to a net loss of $134.6 million, or $0.91 per share
EBITDA was $(225.7) million and adjusted EBITDA was $(23.5) million
Cash, cash equivalents, and marketable securities were $1.38 billion at the end of the quarter
Screening includes laboratory service revenue from Cologuard tests and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype products.

2021 Outlook

The company anticipates revenue of $1,690-$1,735 million during 2021, including Screening revenue of $1,125-$1,150 million, Precision Oncology revenue of $515-$525 million, and COVID-19 testing revenue of $50-$60 million.
The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance that the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Forward-Looking Statements" section of this news release.

Non-GAAP Disclosure
In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, as well as non-GAAP gross margin and non-GAAP gross profit. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. The company believes that these non-GAAP measures are useful in evaluating the company’s operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations."

First Quarter Conference Call & Webcast
Company management will host a conference call and webcast on Tuesday, May 4, 2021, at 5 p.m. ET to discuss first quarter 2021 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 833-235-7650 and international callers should dial +1-647-689-4171. The access code for both domestic and international callers is 5789488.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or +1-416-621-4642 internationally. The access code for the replay of the call is 5789488. The webcast, conference call and replay are open to all interested parties.

About Cologuard
The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated. The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit www.cologuardtest.com.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. The Oncotype MAP Pan-Cancer Tissue test is a rapid, comprehensive tumor profiling panel that aids therapy selection for patients with advanced, metastatic, refractory, or recurrent cancer. With more than 1 million patients tested in more than 90 countries, the Oncotype tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On May 4, 2021 ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric and orphan drugs, reported the inclusion of a first patient in the TEMOkids pediatric clinical study (Press release, ORPHELIA Pharma, MAY 4, 2021, View Source [SID1234579088]). The TEMOkids study aims to determine the pharmacokinetic parameters, tolerance, acceptability and response to treatment of Kimozo, the first oral suspension of temozolomide, in the pediatric population (www.temokids.eu).

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Temozolomide is an anti-cancer drug used in treatment regimens for refractory or relapsed neuroblastoma that mainly affect very young children. It is also used to treat rhabdomyosarcoma and certain brain tumors. The only oral forms of temozolomide currently available are capsules which are not suited to children. In fact, to be administered, the capsules must be opened and their content added to food. In young children, the formulation is essential to ensure correct medication intake, safety, accuracy of the delivered dose and adherence to treatment. To meet the requirements of onco-pediatricians and the needs of children, ORPHELIA Pharma, working in close collaboration with Gustave Roussy hospital teams, has developed Kimozo, the first ready-to-use drinkable suspension of temozolomide.

"The TEMOkids trial, during which our oral suspension of temozolomide will be administered to children for the first time, is a key stage in the clinical development of Kimozo," says Caroline Lemarchand, Chief Pharmaceutical Development Officer for ORPHELIA Pharma, "This study will evaluate the pharmacokinetics of temozolomide, alone or in combination with other treatments, in children from 1 year of age. It will also define the tolerance and acceptability of Kimozo within the study population, and collect data on tumor response to treatment. The first results of this clinical trial are expected mid-2022."

"We are very pleased to be involved in the clinical development of this long-awaited new pediatric formulation of temozolomide for the treatment of cancer in children," says Dr Samuel Abbou, pediatric oncologist at the Gustave Roussy hospital, and coordinating investigator of the TEMOkids study. "The study plans to recruit 40 children in 5 countries; that is France, Germany, Spain, the UK and the Netherlands, thanks to the support of a structured European-scale pediatric oncology network."

"We have received an enthusiastic response from the members of the European pediatric oncology community who have chosen to participate in this clinical trial," says Hugues Bienaymé, General Manager and Chief Scientific Officer for ORPHELIA Pharma, before adding by way of a conclusion that "TEMOkids complements our ongoing bioequivalence study in adult patients, and should support the filing of the Kimozo registration dossier at European level in 2023."

About the TEMOkids study (NCT04610736)

The clinical trial entitled "TEMOkids Study: A Phase I Pediatric Study for KIMOZO, Oral Suspension of temozolomide" is an international, open-label, non-randomized, phase 1 study involving 40 pediatric patients aged 1 year and over. The main objective of this study is to determine the pharmacokinetic parameters of Kimozo in the population concerned by the study. The secondary objectives are to evaluate its tolerance and acceptability among children, and their response to treatment.

Ten clinical centers are involved in the TEMOkids study: Gustave Roussy in Villejuif (the coordinating center); Institut Curie in Paris, France; La Timone Children’s Hospital in Marseille, France; The Institute of Pediatric Hematology and Oncology in Lyon, France; The Oscar Lambret Center in Lille, France; The Charité University Medical Hospital in Berlin, Germany; The Hopp Children’s Cancer Center in Heidelberg, Germany; The Princess Máxima Center for Pediatric Oncology in Utrecht, the Netherlands; The Vall d’Hebron Research Institute in Barcelona, Spain; and Southampton General Hospital in the United Kingdom.

For further information, please go to www.temokids.eu.

About Kimozo

Kimozo (also known as ORP-005 or Ped-TMZ) is a ready-to-use and taste-masked oral suspension of temozolomide that is currently under development to address the needs of children. Kimozo is an investigational medicinal product not yet approved for marketing.

On May 4, 2021 Invectys, Inc., a clinical-stage immunotherapy company headquartered in Houston and dedicated to the development of a new generation of products for cancer patients, reported the appointment of Praveen Tyle, PhD, as President & CEO and election to its Board of Directors (Press release, Invectys, MAY 4, 2021, View Source [SID1234579087]). Dr. Tyle brings over 35 years of experience in both large and small pharma and biotech companies, most recently serving as Executive V.P. for Research and Development of the public company, Lexicon Pharmaceuticals, Inc. Earlier, Dr. Tyle served as the Corporate Senior Vice President and Chief Scientific Officer of Bausch and Lomb and then as Senior Vice President and Global Head of Business Development and R&D at Novartis OTC. Subsequently, Dr. Tyle joined Osmotica Pharmaceutical Corp. serving as President and CEO where he led the successful merger of the Company into Avista Partners in 2016.

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Cary McNair, Chairman of the Board of Invectys and Chairman/CEO of the Houston-based McNair Interests stated: "We are delighted to welcome Praveen as CEO of Invectys. Having served over 3 decades at the intersection of pharma deep science and biopharma business development, Praveen is well poised to lead the commercial development of Invectys’ innovative immunotherapy platforms. His proven management skills and past commercial success bodes well for his new leadership role to steer Invectys into a new stage of commercial development."

Founding investor Shannon Fairbanks, Chair of the Fairbanks Investment Fund Holdings LLC noted: "This is an exciting period producing an explosion of new ideas in the health care sector which is starting to deliver innovative products to cancer patients. Praveen’s vision and leadership will help to deliver a next generation of breakthrough advances in immunotherapy".

Dr Tyle noted, "I am excited to take the helm at Invectys at this propitious time and I look forward to working with the talented team at Invectys to deliver products based on the Company’s strong scientific promise. I intend to apply my biotech and pharma management and product development experience to bring exciting new immunotherapy solutions to market."

In 2020, Invectys was awarded a $14.5 million product development research grant from the prestigious Cancer Prevention and Research Initiative of Texas ("CPRIT") for clinical development of its pathbreaking CAR-T treatment for solid tumors.

On May 4, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAY 4, 2021, View Source [SID1234579086]). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 3 February 2021, Novo Nordisk has repurchased B shares for an amount up to DKK 3.0 billion in the period from 3 February 2021 to 3 May 2021. The programme is now concluded.

Since the announcement as of 26 April 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 5,657,389 B shares of DKK 0.20 as treasury shares, corresponding to 0.2% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12- month period beginning 3 February 2021. As of 3 May 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 6,754,777 B shares at an average share price of DKK 444.12 per B share equal to a transaction value of DKK 2,999,924,849.

On May 4, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported it has commenced clinical trial site recruitment for its upcoming Acclaim-2 clinical trial for the treatment of non-small cell lung cancer (NSCLC) (Press release, Genprex, MAY 4, 2021, View Source [SID1234579085]).

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Acclaim-2 is an open-label, multi-center Phase 1/2 clinical trial that combines Genprex’s lead drug candidate, REQORSA immunogene therapy, with Merck & Co, Inc’s Keytruda in patients with late-stage NSCLC who are low expressors (1% to 49%) of the protein programmed death-ligand 1 ("PD-L1").

"Our clinical team remains focused on engaging with leading clinical investigators and esteemed research institutions in order to further our mission of bringing hope to lung cancer patients who are in need of new treatment options," said Rodney Varner, President and Chief Executive Officer of Genprex. "We look forward to selecting the most optimal study sites, which will help to further fuel the success of our clinical trials."

The Company plans to conduct the Acclaim-2 clinical trial in approximately 15 sites with about 150 patients in an adaptive Phase 1/2 design. The final protocol is subject to change based on input from investigators.Additional information on the Acclaim-2 clinical trial will be posted on ClinicalTrials.gov.