On August 2, 2022 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the company generated revenue of $521.6 million for the second quarter ended June 30, 2022, compared to $434.8 million for the same period of 2021 (Press release, Exact Sciences, AUG 2, 2022, View Source [SID1234617263]).

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"Exact Sciences’ strong second quarter results reflect meaningful progress toward our vision to help eradicate cancer by providing patients better information before diagnosis and throughout their treatment," said Kevin Conroy, chairman and CEO. "We’re focusing on getting more people tested with Cologuard and Oncotype, prioritizing our highest impact projects to reach profitability, and generating high-quality evidence for our pipeline of cancer diagnostic tests."

Second quarter 2022 financial results

For the three-month period ended June 30, 2022, as compared to the same period of 2021 (where applicable):

Total revenue was $521.6 million, an increase of 20 percent
Total revenue, excluding COVID-19 testing, increased 26 percent
Screening revenue was $353.9 million, an increase of 34 percent
Excluding PreventionGenetics acquisition, Screening revenue was $343.7 million, an increase of 30 percent
Precision Oncology revenue was $154.0 million, an increase of 12 percent
COVID-19 testing revenue was $13.8 million, a decrease of 58 percent
Gross margin including amortization of acquired intangible assets was 68 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 72 percent
Net loss was $166.1 million, or $0.94 per share, compared to a net loss of $176.9 million, or $1.03 per share
EBITDA was $(111.4) million and adjusted EBITDA was $(45.8) million
Cash, cash equivalents, and marketable securities were $728.0 million at the end of the quarter
Screening includes laboratory service revenue from Cologuard tests, PreventionGenetics, and immaterial revenue from Biomatrica and Oncoguard Liver products. Precision Oncology includes laboratory service revenue from global Oncotype products and therapy selection products, including oncomap and oncomap ExTra, formerly known as Oncotype Map and GEM ExTra, respectively.

2022 outlook

The company anticipates revenue of $1,980-$2,022 million during 2022, assuming:

Screening revenue of $1,350-$1,372 million, including $40-$42 million from PreventionGenetics,
Precision Oncology revenue of $580-$590 million, including the divestiture of the Oncotype DX Genomic Prostate Score test, and
COVID-19 testing revenue of $50-$60 million.
Revenue guidance has been updated from the previously expected range of $1,985-$2,032 million, which assumed:

Screening revenue of $1,350-$1,372 million, including $40-$42 million from PreventionGenetics,
Precision Oncology revenue of $595-$610 million, and
COVID-19 testing revenue of $40-$50 million.
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."

Second quarter conference call & webcast

Company management will host a conference call and webcast on Tuesday, August 2, 2022, at 5 p.m. ET to discuss second quarter 2022 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608.

An archive of the webcast will be available at exactsciences.com. A replay of the conference call will be available by calling 800-770-2030 domestically or +1-647-362-9199 internationally. The access code for the replay of the call is 4437608. 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 (2021) 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. The Cologuard test 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 cologuard.com. Rx only.

About Exact Sciences’ Precision Oncology portfolio

Exact Sciences’ Precision Oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. In breast cancer, the Oncotype DX Breast Recurrence Score is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The Oncotype DX test is recognized as the standard of care and is included in all major breast cancer treatment guidelines. The Oncomap ExTra test applies comprehensive tumor profiling, utilizing whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the Oncomap ExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. Exact Sciences enables patients to take a more active role in their cancer care and makes it easy for providers to order tests, interpret results, and personalize medicine by applying real-world evidence and guideline recommendations. To learn more, precisiononcology.exactsciences.com.

About PreventionGenetics

Founded in 2004 and located in Marshfield, Wisconsin, PreventionGenetics is a CLIA and ISO 15189:2012 accredited laboratory. PreventionGenetics delivers clinical genetic testing of the highest quality at fair prices with exemplary service to people around the world. PreventionGenetics has 25 PhD geneticists on staff and provides tests for nearly all clinically relevant genes including the powerful and comprehensive germline whole genome sequencing test, PGnome and whole exome sequencing test, PGxome. PreventionGenetics was acquired by Exact Sciences in December 2021.

On August 2, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that management will participate in a fireside chat at the 2022 Wedbush PacGrow Healthcare Conference on Wednesday, August 10th at 10:55 a.m. ET (Press release, SpringWorks Therapeutics, AUG 2, 2022, View Source [SID1234617279]).

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To access the live webcast please visit the Events & Presentations page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

On August 2, 2022 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines designed to bring the curative power of stem cell transplant to more patients, reported that the company will participate in a Gene Modulation Panel Discussion at the 2022 Wedbush PacGrow Healthcare Conference, to be held virtually, on Tuesday, August 9th, 2022 at 9:45 a.m. ET (Press release, Magenta Therapeutics, AUG 2, 2022, View Source [SID1234617295]).

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A live webcast of the panel can be accessed on the Magenta Therapeutics website at View Source The webcast replay will be available for 30 days following the event.

On August 2, 2022 ViewRay, Inc, the U.S. maker of the MRIdian System, reported a partnership with award-winning journalist and cancer advocate Katie Couric’s multi-media company, Katie Couric Media ("KCM") (Press release, ViewRay, AUG 2, 2022, View Source [SID1234617311]). ViewRay and KCM are working together to launch a national awareness campaign to educate patients and clinicians about MRIdian SMART (Stereotactic MRI-guided adaptive radiotherapy) for treatment of pancreatic, prostate, lung, liver, breast, colorectal and oligometastatic cancers.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Nearly 25,000 patients have been treated by over 50 MRIdian systems, including 21 academic and community hospitals in the United States and nearly 30 other hospitals around the world. These centers are pioneering the use of MRIdian SMART treatments and have demonstrated favorable patient outcomes, including extended survival for pancreatic cancer patients and reduced side effects through shorter course treatments for prostate cancer patients. A list of hospitals using MRIdian is located at: View Source

Couric’s life mission is focused on cancer prevention and research. After her first husband, Jay Monahan, died from colorectal cancer more than two decades ago, Couric bravely got a colonoscopy live on NBC’s Today show, which she cohosted from 1991 to 2006, to raise awareness of colon cancer screenings. The same year, she co-founded the National Colorectal Cancer Research Alliance, and then in 2008, Couric co-founded Stand Up To Cancer (SU2C). Since its launch, SU2C has raised more than $700 million to support cutting-edge collaborative science and its research has contributed to nine new FDA-approved therapies.

"I’m thrilled to announce our new partnership with ViewRay. Their one-of-a-kind technology is enabling clinicians to treat patients with targeted, and effective state-of-the-art MRI-guided radiation therapy. Innovation like this gives me hope for the millions of people around the world currently battling cancer" says Katie Couric.

In 2017, Couric and her husband, John Molner, started Katie Couric Media, a multi-media company that creates high-quality content in collaboration with purpose-driven brands that sparks curiosity, elevates conversation, inspires action and moves the world forward. "With over 5 million subscribers across multiple platforms, our audience at KCM is looking to support companies and brands that are innovative, best in class and striving to make a difference. ViewRay’s vision to conquer cancer by re-envisioning radiation therapy is a perfect example of this," says John Molner, Katie Couric Media’s Co-Founder and CEO.

"Thousands of patients treated on MRIdian prove compelling and consistent clinical outcomes in both tough to treat and more common cancers. Patients demand short-course non-invasive therapy with fewer side effects and better quality of life, whether they face complex or more common forms of cancer. ViewRay is committed to delivering that to every patient who requires treatment," said Scott Drake President and CEO of ViewRay. "Our expanding body of clinical data combined with our footprint of MRIdian systems make this the perfect time to partner with Katie and her team. This campaign is an expression and expansion of our dedication to empower cancer patients and their loved ones to find the hope that resides in the best available care."

The MRIdian system provides oncologists outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions, without relying on implanted markers. By providing real-time continuous tracking of the target and organs-at-risk, MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins. This allows for delivery of the prescribed dose to the target, while sparing surrounding healthy tissue and critical structures, which results in minimizing toxicities typically associated with conventional radiation therapy.

Disclaimer:
Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations.

Safety Statement
The MRIdian Linac System is not appropriate for all patients, including those who are not candidates for magnetic resonance imaging. Radiation treatments may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary, or reproductive systems; fatigue; nausea; skin irritation; and hair loss. In some patients, side effects can be severe. Treatment sessions may vary in complexity and duration. Radiation treatment is not appropriate for all cancers. You should discuss the imaging with your doctor to make sure radiation treatment is right for you.

On August 2, 2022 Eleven Therapeutics, a biotechnology company leading the AI revolution in nucleic acid therapeutics, reported that it has raised a total of $22 million in seed funding (Press release, Eleven Therapeutics, AUG 2, 2022, View Source,%2422%20million%20in%20seed%20funding. [SID1234619007]).

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Among the roster of funders is the Bill & Melinda Gates Foundation, which committed $9 million in funding to Eleven, including $5 million towards future equity investment supporting the development of a first-of-its-kind platform that designs small interfering RNAs (siRNAs) with ultra-long durability by utilising high throughput combinatorial chemistry and AI.

Eleven’s platform aims to decipher the Structure-Activity Relationship (SAR) of siRNAs. The number of possible molecular compositions is staggeringly high, exceeding the number of grains of sand on earth. The platform solves this challenge by generating functional data about the activity profile of an unprecedented scale of siRNA molecules in parallel. In order to unlock the rules of SAR, the team is developing a robust deep learning framework. Ultimately, this proprietary, patent-protected, massively parallel screening platform will systematically identify the best combination of building blocks for therapeutic candidates.

"Eleven’s new platform addresses a long-standing challenge in RNAi," said Dr. Greg Hannon, Director of the Cancer Research UK Cambridge Institute at the University of Cambridge, scientific co-founder of Eleven, and one of the world’s leading pioneers in RNAi. "The potential chemical space for optimising these molecules is absolutely massive. Eleven’s solution will map this space by generating unprecedented amounts of data, which can then be leveraged by AI. We are thrilled about this new funding and the vote of confidence by our investors that it represents."

The additional $4 million by the Gates Foundation was awarded as a non-dilutive grant furthering Eleven’s development of prophylactics against endemic and pandemic-poised respiratory viruses. Importantly, the Gates Foundation’s funding will promote wide accessibility of Eleven’s ultimate treatments to people in need in developing countries. The company additionally has a Cooperative Research and Development Agreement (CRADA) with the Vaccine Research Centre of the NIAID.

"I am delighted by the continued success of Eleven Therapeutics," said Dr. Daniel Douek, Chief of the Human Immunology Section at the Vaccine Research Center of the National Institute of Allergy and Infectious Disease, National Institutes of Health. "NIAID has a Research Collaborative Agreement with Eleven with respect to siRNA technologies against pandemic threats. Eleven’s new platform to map the structure-activity relationship of siRNAs to increase their durability and efficacy could play an important part in our collaborative efforts."

"The future equity investment and grant funding from the Gates Foundation propels our revolutionary efforts of mapping the chemical space of oligonucleotide therapeutics. Our platforms pave the way for the discovery of groundbreaking RNAi therapeutics and prophylactics against some of the most devastating diseases of our time," said Prof. Yaniv Erlich, co-founder and CEO of Eleven Therapeutics.

Additional funding sources include Kindred Capital; NFX Bio (formerly TechBio); Harel Technology Investments; Entrée Capital; and the Innovate UK Smart Grant.