On August 2, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) and Forma Therapeutics, Inc. (Nasdaq: FMTX) reported that they have entered into an exclusive, worldwide license agreement to develop, manufacture and commercialize olutasidenib, an oral, small molecule inhibitor of mIDH1 being investigated for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML) and other malignancies (Press release, Rigel, AUG 2, 2022, View Source [SID1234617265]).

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In a Phase 2 registrational study of olutasidenib in patients with mIDH1 R/R AML, olutasidenib demonstrated a robust composite complete remission rate and duration of response and was well-tolerated. The U.S. Food and Drug Administration (FDA) has accepted Forma’s New Drug Application (NDA) for olutasidenib. The Prescription Drug User Fee Act (PDUFA) target action date is February 15, 2023.

"Olutasidenib is a potential market-leading treatment that we believe, based on the registrational Phase 2 data, can improve outcomes in patients with mIDH1+ relapsed or refractory acute myeloid leukemia, and is a strategic fit for our business," said Raul Rodriguez, Rigel’s president and CEO. "This transaction expands our hematology-oncology portfolio and enables us to leverage our strong commercial capabilities to provide a potential new therapy for these patients who remain underserved despite currently available therapies."

"The compelling efficacy and safety data generated to date highlight the potential for olutasidenib to transform the treatment of mIDH1+ R/R AML. The development and approval of olutasidenib, pending a favorable FDA decision, would represent an important milestone for Forma that highlights our R&D capabilities," said Frank Lee, Forma’s president and CEO. "Given Rigel’s focus on hematologic diseases and cancers and the strength of their commercial infrastructure, we believe they are well-positioned to execute on our shared objective of delivering olutasidenib to patients in need."

The registrational cohort of the open-label Phase 2 study evaluated olutasidenib as monotherapy in 153 mIDH1+ R/R AML patients. The primary efficacy-evaluable population of the cohort was comprised of 123 R/R AML patients, who received olutasidenib 150 mg twice daily at least six months prior to the interim analysis cutoff date of June 18, 2020 and had a centrally confirmed IDH1 mutation. The primary endpoint was a composite of a complete remission (CR) plus a complete remission with partial hematological recovery (CRh), defined as less than 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter).

Results from the interim analysis of the trial1 demonstrated a 33% CR+CRh in mIDH1+ R/R AML patients. Among those with CR+CRh, the estimated 18-month survival was 87% and the median duration of CR+CRh was not yet reached, with a more conservative sensitivity analysis indicating a median duration of 13.8 months. Importantly, these data provide compelling evidence of clinical efficacy with a durable response and a favorable tolerability profile, both of which we believe differentiates olutasidenib from other currently available treatment options for mIDH1+ R/R AML patients.

Olutasidenib was well-tolerated, with adverse events (AEs) being consistent with the late stage of disease and the heavily pre-treated population. A safety analysis for all 153 patients enrolled in the registrational Phase 2 study found the most common grade 3/4 (≥ 10%) treatment-emergent adverse events (TEAEs) were febrile neutropenia (20%), anemia (19%), thrombocytopenia (16%), and neutropenia (13%).

Updated data from the registrational study will be presented at an upcoming medical congress.

"The data from the Phase 2 registrational trial of olutasidenib demonstrated encouraging results, particularly on durability and survival, with median duration of response that appears to be longer than currently available treatment options and an 18-month survival rate among those with CR+CRh of 87%," said Jorge E. Cortes, M.D., Director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator. "Given the trial’s compelling efficacy data in duration of response, the favorable tolerability profile, and the still limited treatment options of patients with mIDH1+ R/R AML, olutasidenib has the potential to be an important new treatment option for patients."

Under the terms of the agreement, Forma will receive an upfront payment of $2.0 million, and is eligible to receive an additional $17.5 million upon the achievement of certain near-term regulatory, approval, and first commercial sale milestones. In addition, Forma is eligible to receive a total of up to an additional $215.5 million in connection with the achievement of certain development and commercial milestones. Forma is also eligible to receive tiered royalties in the low-teens to mid-thirties. Moving forward, Rigel will be responsible for the potential launch and commercialization of olutasidenib in the U.S., and intends to work with potential partners to further develop and commercialize olutasidenib outside the U.S.

Conference Call and Webcast Today at 4:30 p.m. Eastern Time, with KOL and Olutasidenib Phase 2 trial investigator, Jorge E. Cortes, M.D.

Rigel will host a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss financial results, provide an update on the business, including the licensing agreement for olutasidenib. The conference call will also feature a presentation of the olutasidenib Phase 2 interim results by Jorge E. Cortes, M.D., Director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator.

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About Olutasidenib and AML
Olutasidenib is an oral, small molecule investigational agent designed to selectively bind to and inhibit mutated IDH1 enzymes. This targeted treatment has the potential to provide therapeutic benefit by reducing 2-HG levels and restoring normal cellular differentiation. IDH1 is a natural enzyme that is part of the normal metabolism of all cells. When mutated, IDH1 activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 6 to 9 percent of patients with AML2. AML is a rapidly progressing cancer of the bone marrow and blood3. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that about 20,940 new cases, most in adults, arose in 2021 in the United States alone.4 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

On August 2, 2022 IDRx, Inc., a clinical-stage biopharmaceutical company dedicated to transforming cancer treatment with purpose-built precision combination therapies, reported that launched with a $122 million oversubscribed Series A financing (Press release, IDRx, AUG 2, 2022, View Source [SID1234617264]). The financing was led by Andreessen Horowitz (a16z) and Casdin Capital, with participation from Nextech Invest, Forge Life Science Partners and other undisclosed investors. Inspired by a few curative combination regimens in cancer and the successful drug cocktails engineered in other disease areas such as cystic fibrosis and antivirals, IDRx was incubated by Borisy Labs to address the limitations of today’s precision cancer medicines with highly selective, purposely designed drug combinations to help more patients achieve prolonged, durable responses to therapy earlier in the course of their disease.

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"Although precision medicines have revolutionized the treatment of some cancers, tumors can evolve multiple escape mutations," said Alexis Borisy, co-founder of IDRx. "At IDRx, we are leveraging deep scientific insights in tumor biology with now available drug engineering capabilities to pioneer novel, selective, intelligently designed combination therapies that aim to hit driver mutations hard, cover escape pathways and provide sufficient therapeutic index and safety profiles for use in early lines of treatment where there is the best potential to provide patients with durable clinical benefits."

"IDRx’s approach offers the opportunity to develop more effective cancer medicines for patients through intentionally built treatment combinations, and we are starting with gastrointestinal stromal tumor (GIST), where tumor biology is well known but, at the same time, there remains a high unmet medical need," said Ben Auspitz, co-founder and CEO of IDRx. "We are proud to assemble this expert team of founders and leaders in precision medicine and in GIST, and to be launching as a clinical-stage company with our first-in-human study for IDRX-42 initiated. Our goal is to build de novo combinations to serve as transformative cancer treatments."

Advancing Pipeline of Precision Cancer Combination Therapies

IDRx’s pipeline includes IDRX-42 and IDRX-73, small molecule tyrosine kinase inhibitors acquired through license agreements with Merck KGaA, Darmstadt, Germany, and Blueprint Medicines, respectively, which are designed to inhibit the key genetic drivers and drug-resistant mutations of non-PDGFR-driven gastrointestinal stromal tumor (GIST), a sarcoma of the GI tract.

A Phase 1 first-in-human study of IDRX-42 has been initiated, and IDRX-73 is currently advancing towards the clinic. IDRX-42 was also recently granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of GIST.

Accomplished Founders and Experienced Leadership

IDRx’s founders and leadership team are comprised of established life science industry leaders with deep expertise in drug development, who collectively have been involved in the discovery, development and commercialization of more than 10 approved drugs.

IDRx Founders:

Alexis Borisy, biotechnology entrepreneur and investor
Ben Auspitz, CEO of IDRx
George Demetri, M.D., FACP, FASCO, FAACR, professor of medicine and co-director of the Ludwig Center at Harvard Medical School; senior vice president for experimental therapeutics and director of the Sarcoma Center at Dana-Farber Cancer Institute
Nicholas Lydon, Ph.D., pioneer in precision medicine and co-winner of the Lasker award for research contributing to the development of Gleevec (imatinib)
Robert Forrester, co-founder and CXO of EQRx
IDRx Management Team and Advisers:

Ben Auspitz, co-founder and CEO
Jessica Christo, chief development operations officer
Vic Kadambi, Ph.D., chief product development officer
Shrenik Desai, vice president, regulatory affairs
Debbie Johnson, vice president, clinical operations
Steve Kelsey, M.D., clinical adviser
Christoph Lengauer, Ph.D., scientific adviser

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 Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, reported that it has entered a collaboration agreement with the West German Study Group (WSG), an international research institution that focuses on practice-changing clinical studies in breast cancer (Press release, Exact Sciences, AUG 2, 2022, View Source [SID1234617262]). Together, Exact Sciences and WSG plan to conduct a prospective, multicenter validation study in hormone receptor (HR)-positive, HER2-negative early breast cancer patients. The study is intended to demonstrate the ability of Exact Sciences’ tumor-informed ctDNA liquid biopsy test to detect minimal residual disease (MRD) and to collect important long-term follow-up and outcome data.

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The combined analysis, called ADAPT Triad, is expected to include data from approximately 3,000 German patients enrolled in two ongoing WSG ADAPT trials and one WSG registry study. All patients included in the analysis are stratified using the Oncotype DX Breast Recurrence Score test. The study is part of Exact Sciences’ global initiative to generate clinical validation data for its tumor-informed ctDNA MRD liquid biopsy test, currently in development.

"This ADAPT Triad project with WSG offers a tremendous opportunity to help inform treatment decisions and recurrence monitoring, and ultimately improve future outcomes for breast cancer patients," said Rick Baehner, MD, chief medical officer of Precision Oncology for Exact Sciences. "In addition to helping validate our MRD assay, we’re also eager to better understand the potential synergies involving the predictive and prognostic information provided by our Oncotype DX Breast Recurrence Score test. WSG’s expertise in breast cancer research makes them ideal collaborators to conduct these important MRD studies in HR positive, HER2-negative early breast cancer."

The ADAPT Triad MRD analysis study in breast cancer builds on Exact Sciences and the National Surgical Adjuvant Breast and Bowel Project’s (NSABP) CORRECT-MRD II clinical validation study to detect MRD in colorectal cancer patients. These studies will help create a solid evidence foundation for Exact Sciences’ MRD program in two core cancer types where the company has established leadership.

"The WSG’s ADAPT study program examines ways to achieve patient-specific decision-making for the treatment of early breast cancer based on biological markers," said Professor Nadia Harbeck, Scientific Director of the WSG and Head of the Breast Centre at LMU Klinikum Munich, Germany. "Partnering with our long-time collaborators at Exact Sciences to evaluate the association of post-initial therapy, pre-recurrence ctDNA with distant recurrence-free interval is a worthy addition to our program and will help change the treatment and monitoring program for solid tumors."

About Minimal Residual Disease
Minimal residual disease (MRD) refers to the presence of tumor-specific DNA in the body after cancer treatment. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the blood by solid tumors as part of the tumor growth cycle. Their presence may indicate that a tumor is likely to return. Solid tumors are typically undetected until they are advanced enough to be picked up by a radiologic image or physician examination. The detection of ctDNA at extremely low levels has the potential to provide crucial insights that may help discover cancer recurrence earlier and inform treatment decisions.

About Exact Sciences’ MRD Program
The Exact Sciences’ MRD program is powered by our in-house capabilities to advance a tumor-informed or a tumor-naïve solution, with an initial focus on tumor-informed (bespoke) with whole exome or whole genome sequencing. This approach identifies somatic genomic alterations in DNA extracted from the patient’s tumor tissue and detects a subset of these mutations in ctDNA present in the patient’s blood. The MRD test that Exact Sciences is developing is intended for patients diagnosed with solid tumor malignancies to detect ctDNA before, during, and after cancer treatment. Such information may be used for guidance of adjuvant therapy decisions and/or for monitoring of cancer recurrence, in conjunction with other clinicopathological findings, providing more than 12 million testing opportunities in the United States alone.1

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 [SID1234617261]).

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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

                  Schedule Your 30 min Free Demo!

"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.