Cologuard® revenue and completed tests increased 87 percent to $90.3 million and 186,000

On April 26, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $90.3 million and completed approximately 186,000 Cologuard tests during the quarter ended Mar. 31, 2018 (Press release, Exact Sciences, APR 26, 2018, View Source [SID1234525737]). First-quarter 2018 revenue and Cologuard test volume both grew 87 percent from 2017.

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!

Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)
"The Exact Sciences team delivered strong growth to start the year by remaining relentlessly focused on our core priorities. By increasing awareness and adoption of Cologuard, we are making strides toward our mission of playing a role in the eradication of colon cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "The success of Cologuard also positions us to develop tests that facilitate the early, accurate detection of other forms of cancer."

First-Quarter 2018 Financial Results

For the three-month period ended Mar. 31, 2018, as compared to the same period of 2017 (where applicable):

Revenue was $90.3 million, an increase of 87 percent, and test volume was 186,000, an increase of 87 percent
Average recognized revenue per test was unchanged at $485; note that the prior period included approximately $4.3 million, or $43 per test, related to the one-time impact of certain payers meeting the company’s revenue recognition criteria for accrual-basis revenue accounting
Average cost per test was $123, an improvement of 28 percent
Gross margin was 75 percent, an increase of 970 basis points
Operating expenses were $103.9 million, an increase of 55 percent
Net loss was $39.4 million or $0.33 per share, compared to $34.9 million or $0.32 per share
Non-cash interest expense related to convertible debt was $5.1 million, or $0.04 per share
Cash utilization was $53.7 million, compared to $36.4 million
Cash, cash equivalents and marketable securities were $1.0 billion at the end of the quarter
Nearly 9,000 healthcare providers ordered their first Cologuard test during the first quarter, and 110,000 (rounded) have ordered since the test was launched
2018 Outlook

The company continues to anticipate revenue of $420-$430 million and completed Cologuard test volume of 900,000-920,000 tests during 2018
For the second quarter, the company anticipates completing 220,000-230,000 Cologuard tests
The company’s guidance for revenue and completed tests are forward-looking statements. They are 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 the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Safe Harbor Statement" section of this press release.

First-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Thursday, Apr. 26, 2018, at 5 p.m. ET to discuss first-quarter 2018 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.

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 8289286. 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 (2014) 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 of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

Editas Medicine to Host Conference Call Discussing First Quarter 2018 Corporate Update and Results

On April 26, 2018 Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, reported that it will host a conference call and webcast on Thursday, May 3, 2018, at 5:00 p.m (Press release, Editas Medicine, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2345072 [SID1234525736]). ET to discuss a corporate update and results for the first quarter of 2018.

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!

To access the call, please dial 844-348-3801 (domestic) or 213-358-0955 (international) and provide the passcode 6079429. A live webcast of the presentation will be available on the Investors & Media section of the Editas website.

CTI BioPharma to Report First Quarter 2018 Financial Results on May 3, 2018

On April 26, 2018 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management plans to report its first quarter 2018 financial results on Thursday, May 3, 2018, after the close of the U.S. financial markets (Press release, CTI BioPharma, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2345109 [SID1234525735]). Following the announcement, members of the management team will host a webcast conference call to discuss the results and provide a general corporate update at 4:30 p.m. ET (1:30 p.m. PT). Access to the event can be obtained as follows:

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!

Thursday, May 3, 2018
1:30 p.m. PT/4:30 p.m. ET
1-866-548-4713 (domestic)
+1 323-794-2093 (international)

To access the live audio webcast or the subsequent archived recording, visit CTI BioPharma’s website, www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available at approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 9956153. The telephone replay will be available until Thursday, May 10, 2018.

Corvus Pharmaceuticals Announces Initiation of Phase 1/1b Clinical Trial of Investigational Anti-CD73 Antibody, CPI-006, in Patients with Advanced Cancer

On April 26, 2018 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported that it is enrolling patients in a multicenter Phase 1/1b clinical trial of CPI-006, a humanized monoclonal antibody directed against CD73 (Press release, Corvus Pharmaceuticals, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2344945 [SID1234525734]). The three-arm study in patients with a variety of solid tumors is evaluating CPI-006 administered as a single agent, in combination with Corvus’ CPI-444, a selective and potent inhibitor of the adenosine A2A receptor, and in combination with pembrolizumab, an anti-PD-1 antibody.

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!

"CPI-006 is an antibody engineered to completely inhibit the CD73 enzyme by binding to its active site. We look forward to evaluating this anti-CD73 antibody in our comprehensive Phase 1/1b trial, which we believe is the first human clinical trial in oncology to evaluate the effect of dual-blockade of the adenosine pathway by inhibiting both CD73 and the A2A receptor," said Richard A. Miller, M.D., an oncologist and co-founder, president and chief executive officer of Corvus. "This trial is designed to answer multiple important questions regarding the role of CD73 blockade and the adenosine pathway in patients with advanced cancer. With the initiation of this new trial and our ongoing Phase 1/1b clinical trial of CPI-444, we continue to reinforce our leadership position in this new therapeutic area."

ABOUT THE PHASE 1/1B TRIAL DESIGN
The Phase 1/1b trial is designed to select the dose and evaluate the safety, pharmacokinetics, immune biomarkers and efficacy of CPI-006 as a single agent, in combination with CPI-444 and in combination with pembrolizumab. Patients with non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and other cancers who have failed standard therapies are eligible. The efficacy endpoints are complete response (CR), partial response (PR), disease control rate, duration of response, progression-free survival and overall survival.

In the dose-selection part of the trial, doses of CPI-006 will be escalated in the single-agent arm and in the two combination arms to determine the maximally tolerated dose or the dose that saturates the CD73 enzyme. Fixed doses of CPI-444 and pembrolizumab will be used. Once an optimum dose of CPI-006 is determined, the second part of the trial will enroll patients in nine cohorts: three will receive CPI-006 alone, three will receive CPI-006 in combination with CPI-444, and three will receive CPI-006 with pembrolizumab. Patients with NSCLC, RCC and the group of other cancers will be enrolled into each of the three disease-specific arms. Each of the nine cohorts may initially enroll up to 11 patients. However, if there is one or more objective responses (CR or PR) in the 11 patients, the cohort may be expanded to 28 patients. The trial may enroll up to 350 patients in total.

ABOUT CD73 AND ADENOSINE
CD73 is a cell surface enzyme whose function is to convert adenosine monophosphate (AMP) to adenosine by removing phosphate from AMP. CD73 is expressed on cells of the immune system, including T-cells and B-cells. CD73 is also present on many tumors, including lung, renal, melanoma, colon, prostate, breast and others. In the tumor microenvironment, CD73 produces adenosine, which binds to the adenosine A2A receptor on immune cells and inhibits various immune responses including those directed against the tumor. Tumors utilize this immunosuppressive mechanism to escape attack by the immune system.

ABOUT CPI-006
CPI-006 is a potent humanized monoclonal antibody that reacts with the active site of CD73, blocking the conversion of AMP to adenosine. In vitro studies of CPI-006 have shown it is capable of substantially inhibiting the production of adenosine by blocking the CD73 enzyme.

ABOUT CPI-444
CPI-444 is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic

Cambrex to Announce First Quarter 2018 Financial Results on May 3, 2018

On April 26, 2018 Cambrex Corporation (NYSE:CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported that first quarter 2018 financial results will be released on Thursday, May 3, 2018 before the market opens (Press release, Cambrex, APR 26, 2018, View Source [SID1234525733]).

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!

The Company will host a conference call to discuss the financial results.

First Quarter 2018 Earnings Conference Call
When: Thursday, May 3, 2018 at 8:30 a.m. Eastern Time
Dial-in: 1-877-260-1479 for U
1-334-323-0522 for International
Passcode: 5093025
Dial-in Replay: 1-888-203-1112 for U.S.
1-719-457-0820 for International
Passcode: 5093025
Available through Thursday, May 10, 2018
Webcast: www.cambrex.com