Cologuard® revenue increased 63 percent to $118 million, and Cologuard test volume grew 49 percent to 241,000 during third quarter

On October 30, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $118.3 million and screened approximately 241,000 people with Cologuard during the quarter ended September 30, 2018 (Press release, Exact Sciences, OCT 30, 2018, View Source [SID1234530394]). Third-quarter 2018 revenue and Cologuard test volume grew by 63 percent and 49 percent, respectively, from the same period of 2017.

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"The Exact Sciences team delivered another strong quarter, highlighted by significantly increased patient access to Cologuard with no out-of-pocket cost and continued progress toward our 2018 priorities," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are enthusiastic about our partnership with Pfizer and launched Cologuard to their internal medicine team in early October. We look forward to working with such a tremendous partner in the fight against colon cancer."

Third-Quarter 2018 Financial Results

For the three-month period ended September 30, 2018, as compared to the same period of 2017 (where applicable):

Revenue was $118.3 million, an increase of 63 percent, and test volume was 241,000, an increase of 49 percent
Average recognized revenue per test was $492, an improvement of 9 percent
Average cost per test was $125, an improvement of 3 percent
Gross margin was 75 percent, an increase of 320 basis points
Operating expenses were $129.2 million, an increase of 61 percent
Net loss was $45.4 million or $0.37 per share, compared to $26.9 million or $0.23 per share
Non-cash interest expense related to convertible debt was $8.4 million, or $0.07 per share
Cash utilization was $36.9 million, compared to $21.7 million
Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter
More than 11,000 healthcare providers ordered their first Cologuard test during the third quarter, and nearly 132,000 have ordered since the test was launched
2018 Outlook

The company anticipates revenue of $435-$440 million for 2018, an increase from prior guidance of $420-$430 million
The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance 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.

Third-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Tuesday, Oct. 30, 2018, at 5 p.m. ET to discuss third-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 6870368. 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. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

Distributed Bio Inc. Announces Collaboration with H3 Biomedicine

On October 30, 2018 Distributed Bio, the global leader in computational optimization of fully human monoclonal antibody libraries, reported a discovery collaboration with H3 Biomedicine, Inc. designed to help accelerate the discovery of novel cancer therapeutics (Press release, Distributed Bio, OCT 30, 2018, View Source [SID1234530430]). The collaboration will leverage Distributed Bio’s proprietary SuperHuman antibody library platform to discover therapeutic-ready, preoptimized antibodies against H3 Biomedicine targets. H3 Biomedicine is a clinical stage biopharmaceutical company specializing in the discovery and development of next-generation cancer medicines using its data science and precision chemistry product engine.

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"H3 Biomedicine is an exciting oncology company, with a novel approach to uncovering targets that could lead to new treatments for unmet needs in various types of cancer," said Jacob Glanville Ph.D., Co-founder & CSO, Distributed Bio. "What was clear to us from the outset was that H3 Biomedicine’s goals would require significant advances to the normal antibody selection process. At Distributed Bio we are uniquely positioned to provide the advanced selection, screening and engineering techniques needed to advance important discovery programs."

Under the terms of the agreement, Distributed Bio will discover antibodies by screening its SuperHuman antibody library with antigens provide by H3 Biomedicine. Multiple lead antibodies will be identified using a proprietary assay cascade. The antibodies generated through this method will be available to H3 Biomedicine to advance to clinical development. Distributed Bio will receive research funding and the opportunity for future milestone payments.

"At H3 Biomedicine, we are focused on uncovering novel cancer biology and rapidly translating those learnings to advance novel, first-in-class precision oncology medicines. As our lead clinical development programs continue to progress, we are also pursuing a broad portfolio of research programs and targets," said Andrea Gerken, Vice President, Business Development at H3 Biomedicine. "As part of those research efforts, our collaboration with Distributed Bio will enable us to explore H3’s differentiated approach to antibody drug conjugates targeting RNA splicing."

Nektar to Announce Financial Results for the Third Quarter 2018 on Wednesday, November 7, 2018, After Close of U.S.-Based Financial Markets

On October 30, 2018 Nektar Therapeutics (Nasdaq: NKTR) reported that it will announce its financial results for the third quarter on Wednesday, November 7, 2018, after the close of U.S.-based financial markets (Press release, Nektar Therapeutics, OCT 30, 2018, View Source [SID1234530449]). Howard Robin, president and chief executive officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time (ET)/2:00 p.m. Pacific Time (PT).

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The press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, December 10, 2018.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 9395678 (Nektar Therapeutics is the host

BioTime to Report Third Quarter 2018 Financial Results on November 8th, 2018

On October 30, 2018 BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company focused on degenerative diseases, reported that it will report its third quarter 2018 financial and operating results on Thursday, November 8th, 2018, following the close of the U.S. financial markets (Press release, BioTime, OCT 30, 2018, View Source;p=RssLanding&cat=news&id=2374117 [SID1234530372]). BioTime management will also host a conference call and webcast on Thursday, November 8th, 2018, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2018 financial results and to provide a business update.

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Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and should request the "BioTime Inc. Call". A live webcast of the conference call will be available online in the Investors section of BioTime’s website. A replay of the webcast will be available on BioTime’s website for 30 days and a telephone replay will be available through November 15th, 2018, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and entering conference ID number 8658619.

INmune Bio to Present at National Investment Banking Association Conference

On October 30, 2018 INmune Bio, Inc., a cancer immunotherapy company focused on developing therapies that harness the patient’s innate immune system to attack their cancer, reported that RJ Tesi, M.D., CEO and President of the Company, will present a company overview at the upcoming National Investment Banking Association Conference, with details as follows (Press release, INmune Bio, OCT 30, 2018, View Source [SID1234530395]):

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National Investment Banking Association 145th Investment Conference

Date and Time: Thursday November 1, 2018 at 9:30 a.m. Eastern time
Venue: Crowne Plaza Times Square, New York City