1stOncology™: Cancer Intelligence Service – Page 11190 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Harpoon Therapeutics Reports First Quarter 2020 Financial Results and Provides Corporate Update

On May 6, 2020 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, Harpoon Therapeutics, MAY 6, 2020, View Source [SID1234557135]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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!

"Harpoon has made remarkable progress since the beginning of 2020, highlighted by the initiation of clinical development for our third novel TriTAC program, HPN217, for the treatment of multiple myeloma," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "We continue to advance both of our lead clinical programs for HPN424 and HPN536 and plan to present interim clinical data for both of these studies this year. In addition, we are enrolling the clinical trial for HPN217 and are on track to file an IND followed by initiation of our fourth clinical trial for HPN328 in the second half of this year."

First Quarter 2020 Business Highlights and Other Recent Developments

In April, Harpoon announced the first patient was dosed with HPN217 in a Phase 1/2 clinical trial focused on relapsed/refractory multiple myeloma (RRMM). HPN217 is covered by a global development and option agreement with AbbVie Inc. (NYSE: ABBV) and treatment of the first patient in the clinical trial has triggered a $50 million milestone payment to Harpoon. HPN217 targets B-cell maturation antigen (BCMA), a well-validated target expressed on multiple myeloma cells. HPN217 is Harpoon’s third product candidate to enter the clinic and is based on Harpoon’s proprietary Tri-specific T cell Activating Construct (TriTAC) platform designed to recruit a patient’s own immune cells to destroy tumors.

In April, Harpoon appointed Andrew R. Robbins and Joseph S. Bailes, M.D., to its Board of Directors. Among his many achievements, Mr. Robbins is credited with leading the highly successful U.S. launch of BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) in BRAF-mutant metastatic melanoma. Dr. Bailes is a medical oncologist with substantial experience in clinical practice, legislation, public policy and advocacy, and for nearly two decades, served in various executive leadership capacities with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) including as President.

Patient enrollment and dose escalation continues in the Phase 1 trials for HPN424 in metastatic castration resistant prostate cancer and in the Phase 1/2a trial for HPN536, initially for ovarian and

pancreatic cancers. Harpoon plans to present interim HPN424 data at the ASCO (Free ASCO Whitepaper) 2020 Virtual Meeting (Abstract 5552). The Company will host a virtual event to provide a clinical trial and pipeline update in parallel with the ASCO (Free ASCO Whitepaper) meeting.

Anticipated 2020 Milestones

HPN424 – present interim data from the dose escalation phase of our Phase 1 trial at ASCO (Free ASCO Whitepaper)20 Virtual and initiate expansion cohort in 2020

HPN536 – present interim data from Phase 1/2a trial in the second half of 2020

HPN217 – initiate a Phase 1/2 trial in the first half of 2020 (Completed)

HPN328 – initiate Phase 1/2a trial in the second half of 2020

First Quarter 2020 Financial Results

Harpoon ended the first quarter of 2020 with $138.2 million in cash, cash equivalents, and marketable securities compared to $155.1 million as of December 31, 2019. This figure does not include the $50 million milestone payment achieved through the AbbVie agreement noted above.

Revenue for the first quarter ended March 31, 2020 was $3.3 million compared to $1.1 million for the first quarter ended March 31, 2019. The increase in revenue was primarily due to revenue recognized from the upfront payment under the development and option agreement with AbbVie, signed in November 2019.

Research and development expense for the first quarter ended March 31, 2020 was $12.5 million compared to $9.4 million for the first quarter ended March 31, 2019. The increase primarily arose from clinical development expenses and an increase in personnel-related expenses, which included conducting preclinical studies, the continuation and preparation of the clinical trials for HPN424, HPN536 and HPN217, and manufacturing activities for four TriTAC product candidates in various stages of development.

General and administrative expenses for the quarter ended March 31, 2020 was $3.9 million compared to $5.8 million for the quarter ended March 31, 2019. The decrease was due to higher expenses incurred in the first quarter of 2019 primarily related to legal fees associated with Maverick litigation, and consulting and accounting services, offset by an increase in personnel expenses related to an increase in headcount, and other professional services to support our ongoing operations as a public company.

Net loss for the quarter ended March 31, 2020 was $12.6 million compared to $13.6 million for the quarter ended March 31, 2019.

COVID-19 Update

In response to the COVID19 pandemic, Harpoon notes that it closed its executive offices in compliance with county and state shelter-in-place orders, the result of which is that substantially all of the Company’s employees are currently telecommuting, and there is only a limited the number of staff working in the Company’s laboratory. Harpoon is currently continuing its clinical trials it has underway in sites in the United States, and has not yet experienced any material delays or impacts as a result of the pandemic. In addition, Harpoon’s third-party contract manufacturers continue to operate at or near normal levels and the Company does not currently anticipate material interruptions. Harpoon continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including its programs, expected timelines, expenses, manufacturing and clinical trials. The full extent to which the COVID-19 pandemic may have a negative impact on Harpoon’s business, results of operations and financial condition, and will depend on future developments that are highly uncertain and cannot be accurately predicted.

Constellation Pharmaceuticals Announces First-Quarter 2020 Financial Results

On May 6, 2020 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its first-quarter 2020 financial results (Press release, Constellation Pharmaceuticals, MAY 6, 2020, View Source [SID1234557134]).

"In the face of the serious public health and economic impacts of the COVID-19 pandemic, we at Constellation remain focused on our mission of addressing unmet medical needs in cancer and hematological diseases," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "We are continuing to make progress on each of our development programs and are steadily advancing toward our goal of becoming a fully integrated hematology / oncology company with a sustainable product pipeline.

"Our vision is to transform the standard of care in myelofibrosis with CPI-0610. Encouraging preliminary data on CPI-0610 suggest possible disease-modifying effects, including improvement in bone marrow fibrosis, hemoglobin increases, and conversion of transfusion dependence to transfusion independence, as well as spleen volume reductions and symptom improvement – both in combination with ruxolitinib and as a monotherapy.

"We are also working to create novel treatments for patients in other therapeutic areas," Mr. Raythatha concluded. "We believe that our EZH2-inhibitor franchise of CPI-1205 and CPI-0209 provides potential opportunities to treat a wide range of oncology patients, and we aim to achieve important milestones with each of these molecules this year."

Program Updates

CPI-0610

On May 14, we expect three abstracts to publish in association with the European Hematology Association (EHA) (Free EHA Whitepaper). We will provide an update with 12-week data from 29 JAK-inhibitor-naïve (first-line) patients, 24-week data from 15 JAK-inhibitor-naïve patients, and 24-week data from 48 JAK-inhibitor-experienced (second-line) patients.

Data will include preliminary evidence of disease modification, including bone marrow fibrosis, hemoglobin changes, and conversion from transfusion dependence to transfusion independence, in addition to spleen and symptom improvement.

In mid-June, we expect to present a further update in conjunction with the EHA (Free EHA Whitepaper) meeting, including 12-week data from approximately 50 first-line patients, and 24-week data from 25-30 first-line patients and 70-80 second-line patients.

We aim to start a global clinical trial for CPI-0610 in the first-line setting during the second half of 2020.

We continue to plan to meet with the FDA in mid-2020 to discuss the future development of CPI-0610.

The ProSTAR trial is fully enrolled and we plan to determine next steps for CPI-1205 after taking a mid-year data cut. As we previously discussed, our plans for any potential Phase 3 program for CPI-1205 will depend on our assessment of these data on duration of effect, as well as other considerations.

The Phase 1 clinical trial for CPI-0209 is proceeding as planned, and we expect to determine a recommended Phase 2 dose in the second half of 2020. Once we have established the Phase 2 dose we plan to start a broad-based expansion study in solid tumors.

Impact of COVID-19

Execution of ongoing clinical trials. Patient safety remains paramount in the execution of our clinical trials. In the face of the COVID-19 pandemic, we continue to treat patients in our MANIFEST, ProSTAR, and CPI-0209 clinical trials.

Patient enrollment in MANIFEST began to slow toward the end of first quarter of 2020. Prior to the pandemic, we had met or exceeded our internal enrollment goal for MANIFEST, and we continue to assess what impact the pandemic could have on our MANIFEST trial timeline. Similarly, while we have had incidences of incomplete data collection to date, we are utilizing provisions of the protocol and recent regulatory guidance that provide potential flexibility in the time and place of data collection, and we will continue to monitor the situation. We expect to provide a data update at EHA (Free EHA Whitepaper) similar to our plans prior to the COVID-19 outbreak.

To date, we have not seen a significant impact of COVID-19 on clinical trials for CPI-1205 or CPI-0209. The ProSTAR trial for CPI-1205 is proceeding, and we continue to expect to do a data cut in mid-2020 and to provide an update shortly thereafter. Our CPI-0209 Phase 1 trial continues as planned before the COVID-19 outbreak and we continue to expect to determine a recommended Phase 2 dose in the second half of 2020.

CPI-0610 Phase 3 clinical trial. Conditions at clinical trial sites caused by COVID-19 may impact the timing of the start of our Phase 3 clinical trial for CPI-0610. However, we still aim to begin this trial in the second half of 2020.

Manufacturing. We have experienced some disruption in our supply chain due to COVID-19. However, supply chain disruptions have not impacted our overall timelines for conducting clinical trials to date, and we continue to manufacture batches for our ongoing clinical trials.

Milestones

The Company anticipates achieving the following milestones during 2020:

CPI-0610 – Provide MANIFEST program update at EHA (Free EHA Whitepaper) in June

CPI-0610 – Initiate Phase 3 clinical trial in second half of 2020

CPI-0610 – Provide additional MANIFEST program update by end of year

CPI-1205 – Provide ProSTAR program update and determine next steps mid-year

CPI-0209 – Provide program update, including recommended Phase 2 dose, by end of year

First Quarter 2020 Financial Results

Cash, cash equivalents, and marketable securities as of March 31, 2020, were $358.8 million, a decrease of 6.5% compared to December 31, 2019, primarily due to operating expenses.

Research and development (R&D) expenses increased 28.1% year over year to $20.1 million in the first quarter of 2020, mainly due to increased clinical trial expenses.

General and administrative (G&A) expenses grew 33.4% year over year to $5.9 million in the first quarter of 2020, primarily due to building out the organization of the company.

The net loss attributed to common shareholders increased 31.0% year over year to $25.4 million for the first quarter of 2020, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 18.7% to $0.61 per share due to an increase in shares outstanding as a result of the private placement in October 2019 and the public offering in December 2019, offset in part by the increased net loss.

Financial Guidance

Constellation expects that its current cash, cash equivalents, and marketable securities will enable it to fund operations into the second half of 2022.

Constellation will host a conference call at 8:00 AM EDT on May 6, 2020, to discuss its clinical programs and financial results. The event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at View Source To participate in the live question-and-answer session, please dial (877) 473-2077 (domestic) or (661) 378-9662 (international) and refer to conference ID 4372778.

G1 Therapeutics Provides First Quarter 2020 Corporate and Financial Update

On May 6, 2020 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the first quarter ended March 31, 2020 (Press release, G1 Therapeutics, MAY 6, 2020, View Source [SID1234557133]).

"We have activated business continuity plans in response to the COVID-19 pandemic to ensure we can advance therapies that patients with cancer, their families, and healthcare providers are counting on to improve outcomes, and also taken actions to safeguard the well-being of our employees," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "We are on track to complete a New Drug Application filing for trilaciclib for patients with small cell lung cancer this quarter, and have initiated virtual medical education programs as we prepare for commercial launch in the U.S. We remain committed to evaluating the benefits of trilaciclib in other indications and expect to initiate the I SPY-2 breast cancer trial this quarter and a pivotal trial in colorectal cancer in the fourth quarter of 2020. Cancer patients experiencing chemotherapy-induced myelosuppression are an especially vulnerable population, and trilaciclib has the potential to be the first proactively administered myelopreservation therapy for these patients."

First Quarter Regulatory, Clinical and Corporate Highlights

NDA submission for trilaciclib in small cell lung cancer (SCLC) expected in 2Q20. A rolling NDA submission to the U.S. Food and Drug Administration (FDA) began in the fourth quarter of 2019 and is expected to be completed this quarter.

Pivotal trial of trilaciclib in colorectal cancer expected to begin in 4Q20. In 2Q20, the company discussed the design of a registrational clinical trial of trilaciclib in colorectal cancer with the FDA at a pre-Phase 3 meeting. The trial is on track to begin in the fourth quarter of 2020.

I-SPY 2 neoadjuvant breast cancer trial including trilaciclib on track for 2Q20 initiation. Trilaciclib was selected for inclusion in the ongoing Phase 2 I-SPY 2 TRIAL based on compelling overall survival (OS) findings in a Phase 2 triple-negative breast cancer (TNBC) trial (press release here). The I-SPY trial will generate data across a range of breast cancer subtypes that will allow the company to evaluate trilaciclib in combination with several broadly-used chemotherapy classes and an anti-PD-1 immunotherapy.

Initiation of rintodestrant and Ibrance combination trial on track for 2Q20. The company previously announced preliminary safety, tolerability and efficacy data on rintodestrant, its oral selective estrogen receptor degrader (SERD) (press release here) as monotherapy treatment for ER+, HER2- breast cancer. Based on these findings, G1 plans to initiate an additional arm of its ongoing Phase 1/2a trial in the second quarter of 2020 to explore the combination regimen of rintodestrant and the CDK4/6 inhibitor Ibrance (palbociclib). Palbociclib will be provided by Pfizer Inc. under a non-exclusive clinical supply agreement.

Soma Gupta named as Chief Commercial Officer. In March, the company appointed Soma Gupta as its Chief Commercial Officer (CCO) with responsibility for leading commercial preparations for the launch of trilaciclib in the U.S. Ms. Gupta and her team are focused on developing a patient access strategy that illustrates the value that trilaciclib can provide to patients and the healthcare system. Prior to joining G1, Ms. Gupta led the global commercial launch of Vyndaqel (tafamidis meglumine) while serving as Vice President, Global Marketing for Amyloidosis and Cardiac Rare Disease at Pfizer Inc. Previously, she led the global commercial team responsible for Pfizer’s oncology portfolio, including Ibrance (palbociclib).

Changes to the Board of Directors. In March, the company named Jack Bailey to its board of directors. Mr. Bailey most recently served as President – U.S. at GlaxoSmithKline (GSK) and is a past member of the board of directors of Pharmaceutical Research and Manufacturers of America (PhRMA). Sir Andrew Witty, who joined the G1 board in July 2017, has retired from this position. Sir Andrew recently took a leave of absence from his current role as president, UnitedHealth Group and CEO of Optum to co-lead the World Health Organization (WHO) COVID-19 vaccine program.

"On behalf of our shareholders and associates, I want to thank Sir Andrew for his many contributions to G1. He has provided valuable insights and counsel, particularly related to patient access and the global reimbursement landscape," said Dr. Velleca. "We commend him for applying his considerable talents and experience to the WHO COVID-19 vaccine initiative."

COVID-19 impact on operations. The company has implemented business continuity plans to address the COVID-19 pandemic and minimize disruptions on ongoing operations. The timeline for filing the trilaciclib NDA has not been impacted by COVID-19, and the company expects to complete the NDA submission in the second quarter of 2020. Initiation of two clinical trials, the rintodestrant/palbociclib combination trial and the I-SPY 2 trial, is on track to begin in 2Q20. Initial enrollment of these trials is likely to be impacted by COVID-19. The company does not anticipate significant supply chain delays or shortages as a result of the COVID-19 pandemic.

First Quarter 2020 Financial Highlights and 2020 Guidance

Cash Position: Cash and cash equivalents totaled $242.4 million as of March 31, 2020, compared to $269.2 million as of December 31, 2019.

Operating Expenses: Operating expenses were $31.8 million for the first quarter of 2020, compared to $25.9 million for the first quarter of 2019. GAAP operating expenses include stock-based compensation expense of $4.7 million for the first quarter of 2020, compared to $3.8 million for the first quarter of 2019.

Research and Development Expenses: Research and development (R&D) expenses for the first quarter of 2020 were $20.4 million, compared to $18.1 million for the first quarter of 2019. The increase in R&D expenses was primarily due to an increase in clinical program costs, costs for manufacturing pharmaceutical active ingredients, and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the first quarter of 2020 were $11.4 million, compared to $7.8 million for the first quarter of 2019. The increase in G&A expenses was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities, increase in medical affairs costs, and an increase in professional fees and other administrative costs necessary to support our operations.

Net Loss: G1 reported a net loss of $31.0 million for the first quarter of 2020, compared to $24.0 million for the first quarter of 2019.

2020 Guidance: The company is reiterating its previous financial guidance and expects to end 2020 with $110-$130 million in cash and cash equivalents, prior to the consideration of potential proceeds from partnerships, collaboration activities, and/or other sources of capital. The company expects current cash and cash equivalents to be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2021.

Key Anticipated 2020 Milestones

Complete NDA submission for trilaciclib in SCLC in 2Q20.

Initiate I-SPY 2 clinical trial of trilaciclib in neoadjuvant breast cancer in 2Q20.

Initiate additional arm of rintodestrant Phase 1/2a trial to evaluate combination with Ibrance (palbociclib) in 2Q20; additional Phase 1/2a monotherapy data expected in 4Q20.

Initiate Phase 3 clinical trial of trilaciclib in colorectal cancer in 4Q20.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the first quarter 2020 ended March 31, 2020. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 5669692. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

Veracyte Announces First Quarter 2020 Financial Results

On May 6, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the first quarter ended March 31, 2020 and provided an update on recent business progress (Press release, Veracyte, MAY 6, 2020, View Source [SID1234557132]).

"Despite late-quarter challenges from the COVID-19 pandemic, we delivered solid results for the first quarter of 2020, with strong revenue and volume growth across our genomic testing business. We continued to strengthen our position for long-term success by advancing our pipeline and solidifying our infrastructure for global expansion. We also established a new biopharmaceutical partnership in lymphoma, our newest clinical indication, and made strong progress with all of our biopharmaceutical collaborations," said Bonnie Anderson, chairman and chief executive officer of Veracyte.

"While we anticipate impact to our business from the pandemic through 2020, we believe we are well-positioned to emerge strong over the long term due to the fundamental strength and diversification of our business, as well as our strong cash position. Moreover, we believe our focus on improving diagnosis and treatment decisions for patients with cancer and lung disease, while reducing unnecessary procedures, aligns with the needs of our healthcare system."

First Quarter 2020 Financial Results

For the first quarter of 2020, as compared with the first quarter of 2019:

Total Testing and Product Revenue was $30.4 million, an increase of 20%; including biopharmaceutical revenue, total revenue was $31.1 million, an increase of 5%;
Gross Margin was 61%, which included a $1.1 million write-down of supplies;
Operating Expenses, Excluding Cost of Revenue, were $31.1 million, an increase of 35%;
Net Loss and Comprehensive Loss was $(11.7) million, versus $(1.9) million;
Basic and Diluted Net Loss Per Common Share was $(0.24), versus $(0.05);
Net Cash Used in Operating Activities was $5.3 million, versus $1.0 million; and
Cash and Cash Equivalents were $153.1 million at March 31, 2020.
COVID-19 Impact and Recent Events

As previously announced, Veracyte’s business was impacted by the COVID-19 pandemic and the company observed genomic testing volume decline in the second half of March and through April, where it experienced an over-50 percent volume decline during the month compared to prior year. In response to this unprecedented challenge, the company took the following steps to reduce costs:

Veracyte’s chairman and chief executive officer reduced her base pay and target bonus by 25% until the company resumes normal operations.
Veracyte’s board of directors, executive leaders and certain other employees took a reduction in pay until the company resumes normal operations.
Approximately 60 employees were put on a temporary furlough with a goal of bringing them back from furlough once the company’s business rebounds. Veracyte will continue at this time to provide furloughed employees certain benefits including covering employee healthcare contributions during the furlough. In addition, Veracyte terminated a small number of employees.
Instituted a temporary hiring freeze.
Secured vendor discounts and halted all nonessential outside spending.
First Quarter 2020 and Recent Business Highlights

Core Diagnostics Business:

Grew total genomic test volume (Afirma, Percepta and Envisia) by 15% to 10,559 tests.
Launched "More About You," a national campaign to help patients navigate the work-up of thyroid nodules and ask for Afirma testing by name.
Announced that data accepted for oral presentation at the ENDO 2020 conference identified novel or rare gene fusions that are included in the newly expanded Afirma Xpression Atlas and may potentially be targeted with drugs that are approved or under development.
Reported new data published in npj Breast Cancer, which suggest potential growth opportunities for the Prosignatest in global markets where the test reports intrinsic breast cancer subtypes. Additionally, data published in Clinical Breast Cancer suggest the Prosigna test’s ability to provide significant prognostic information beyond clinicopathologic factors in patients with invasive lobular breast cancer, a major breast cancer histopathologic subtype.
Strategic Collaborations and Pipeline Advancement:

Secured an exclusive licensing and research agreement with Yale University to advance the first genomic monitoring test for idiopathic pulmonary fibrosis prognosis, complementing our Envisia classifier for improved early diagnosis of the disease. The non-invasive, blood-based test was developed for use on our nCounter diagnostic platform.
Signed an exclusive licensing agreement with Boston University for technology that will help advance development of the first-ever, non-invasive nasal swab test for lung cancer early detection.
Announced a multi-year collaboration with Acerta Pharma, the hematology research and development arm of AstraZeneca plc, to provide genomic information that will support the biopharmaceutical company’s development of oncology therapeutics in lymphoma.
Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

Exact Sciences Announces First Quarter 2020 Results

On May 6, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $347.8 million for the first quarter ended Mar. 31, 2020, compared to $162.0 million for the same period of 2019 (Press release, Exact Sciences, MAY 6, 2020, View Source [SID1234557131]).

"Even in unprecedented times, cancer doesn’t stop. The coronavirus pandemic highlights and increases the need for novel ways to screen for cancer, detect it early, and guide treatment. Our Cologuard, Oncotype DX, and Paradigm tests meet that need," said Kevin Conroy, chairman and CEO. "In a world that is trying to avoid unnecessary physician office visits, invasive procedures, and treatments, our tests and deep pipeline are more valuable now than ever. We plan to play an even greater role in cancer screening and guiding therapy decisions after the coronavirus pandemic abates."

First Quarter 2020 Financial Results

For the three-month period ended March 31, 2020, as compared to the same period of 2019 (where applicable):

Total revenue was $347.8 million, compared to $162.0 million

Screening revenue was $219.5 million, an increase of 35 percent

Precision Oncology revenue was $128.4 million

Gross margin including amortization of acquired intangible assets was 71 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 77 percent

Net loss was $105.7 million, or $0.71 per share, compared to a net loss of $82.9 million, or $0.66 per share

EBITDA was $(51.0) million and adjusted EBITDA was $(8.2) million

Non-cash interest expense related to convertible debt was $22.5 million, which included a non-cash loss on extinguishment of debt of $8.0 million, compared to $19.6 million, which included a non-cash loss on extinguishment of debt of $10.6 million

Cash, cash equivalents, and marketable securities were $1.2 billion at the end of the quarter, including $975.5 million, net, raised in relation to the issuance of new convertible notes and the repayment of a portion of previously issued convertible notes

Screening includes laboratory service revenue from Cologuard and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype DX products and the recent Paradigm acquisition.

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."

First Quarter Conference Call & Webcast
Company management will host a conference call and webcast on Wednesday, May 6, 2020, at 5 p.m. ET to discuss first quarter 2020 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.

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 416-621-4642 internationally. The access code for the replay of the call is 7874149. The webcast, conference call and replay are open to all interested parties.

About Cologuard
Cologuard 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. Cologuard 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). Cologuard 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 Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard 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 Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx only.

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. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.