On July 30, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the second quarter ended June 30, 2019 and provided an update on recent business highlights (Press release, Veracyte, JUL 30, 2019, View Source [SID1234537912]). For the second quarter of 2019, revenue was $30.1 million, an increase of 32% over the second quarter of 2018. Net cash used in operating activities in the second quarter of 2019 was $2.5 million, an improvement of 21% compared with the second quarter of 2018.

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"Our strong second quarter performance was fueled by the growth of our products in three clinical indications, biopharmaceutical services revenue from milestone achievements and operational and financial discipline," said Bonnie Anderson, chairman and chief executive officer of Veracyte. "In addition, we completed the transition of all three of our classifiers to our RNA whole-transcriptome sequencing platform with the launch of our Percepta Genomic Sequencing Classifier, positioning the company to advance our pipeline to address additional questions across the clinical care continuum."

Second Quarter 2019 Financial Results

For the second quarter of 2019 as compared with the second quarter of 2018:

Revenue was $30.1 million, an increase of 32%; excluding $3.5 million of biopharmaceutical services revenue, revenue was $26.7 million, an increase of 20%.
Gross Margin was 71%, an increase of seven percentage points; excluding biopharmaceutical services revenue, gross margin was 67%, an increase of four percentage points.
Operating Expenses, Excluding Cost of Revenuewere $24.5 million, an increase of 20%.
Net Loss was $2.5 million, an improvement of 60%.
Net Loss Per Share was $0.05, an improvement of 72%.
Net Cash Used in Operating Activities was $2.5 million, an improvement of 21%.
Cash and Cash Equivalents was $192.6 million at June 30, 2019.
For the six-month period ended June 30, 2019, as compared with the prior year period of 2018:

Revenue was $59.7 million, an increase of 39%; excluding $7.6 million of biopharmaceutical services revenue, revenue was $52.1 million, an increase of 23%.
Gross Margin was 71%, an increase of nine percentage points; excluding biopharmaceutical services revenue, gross margin was 67%, an increase of five percentage points.
Operating Expenses, Excluding Cost of Revenue were $47.5 million, an increase of 14%.
Net Loss was $4.4 million, an improvement of 71%.
Net Loss Per Share was $0.10, an improvement of 78%.
Net Cash Used in Operating Activities was $3.5 million, an improvement of 67%.
Second Quarter 2019 and Recent Business Highlights

Commercial Growth and Reimbursement Expansion:

Launched the "next-generation" Percepta Genomic Sequencing Classifier (GSC) in June 2019, ahead of the company’s expectations, completing the transition of all of the company’s classifiers to its RNA whole-transcriptome sequencing platform.
Grew total genomic test volume in the second quarter of 2019 to 9,663, an increase of 26% over the second quarter of 2018.
Increased Percepta classifier test volume to 744 tests and revenue to more than $1.0 million, representing a 142% and 159% increase, respectively, compared with the second quarter of 2018.
Ramped Envisia Genomic Classifier test volume as well as the number of institutions ordering the test by more than 100% sequentially from the first quarter of 2019 to 130 tests and 76 sites, respectively.
Grew Afirma classifier test volume to 8,789 tests, an increase of 19% over the second quarter of 2018.
Achieved in-network status with four Blue Cross Blue Shield plans in New Jersey, North Carolina, South Carolina and Vermont, covering nearly 8.5 million medical members.
Strengthened Library of Clinical Evidence:

Unveiled clinical validation data for the Percepta GSC during ATS 2019, demonstrating the test’s ability to down-classify lung nodule patients to "low risk" for cancer so they may avoid unnecessary invasive procedures (NPV of 91%), while also up-classifying patients to "high risk" to help guide next steps (PPV of 65%).
Published clinical validation and utility study findings for the Envisia classifier in The Lancet Respiratory Medicine, showing that the test helps physicians distinguish idiopathic pulmonary fibrosis (IPF) from other interstitial lung diseases without the need for surgery, and that when paired with HRCT results and patient clinical history, the test provided physicians with a higher level of confidence in making an IPF diagnosis.
Positive data were presented at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrating the ability of the Afirma Xpression Atlas (XA) to identify gene mutations in medullary thyroid cancer that may guide targeted treatment decisions for patients concurrent with diagnosis by the Afirma GSC.
Independent clinical utility study for the Afirma GSC was published in Thyroid showing that use of the test enabled Ohio State University researchers to identify significantly more benign thyroid nodules and therefore meaningfully decrease surgeries compared to the original test.
Publication in Cancer Cytopathology detailed how new RNA sequencing-based genomic testing, the technology behind the Afirma GSC and Afirma XA, is helping to reduce unnecessary surgeries in thyroid cancer diagnosis and inform on surgery and treatment decision-making using the same minimally invasive patient sample.
Financing and Debt Facility

Issued and sold 6,325,000 shares of common stock in May 2019 in a registered public offering, including the underwriters’ exercise in full of their option to purchase an additional 825,000 shares, at a price to the public of $23.25 per share. Net proceeds from the offering were approximately $137.8 million.
Used $12.4 million of offering proceeds to reduce the company’s principal debt balance from $12.5 million at the end of the first quarter of 2019 to $0.1 million at the end of the second quarter of 2019.
Updated 2019 Financial Outlook

Veracyte is increasing its 2019 annual revenue guidance to a range of $119 million to $122 million from its previous guidance range of $117 million to $121 million. The company is also revising its full-year 2019 guidance for net cash used in operating activities to a range of $2 million to $4 million from its prior guidance of $4 million to $6 million. Veracyte continues to expect to achieve operating cash flow breakeven before the end of this year.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast to discuss its financial results and provide a general business update at 5:00 p.m. Eastern time today.

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

The conference call can be accessed as follows:

U.S./Canada participant dial-in number (toll-free):

(855) 541-0980

International participant dial-in number:

(970) 315-0440

Conference I.D.:

9769085

On July 30, 2019 Exicure, Inc. (OTCQB: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Exicure, JUL 30, 2019, View Source [SID1234537911]). In addition, Exicure intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of its common stock offered in the public offering. All of the shares are being offered by Exicure. Exicure also announced that its common stock has been approved for listing on the Nasdaq Capital Market, subject to the pricing of the public offering on the terms proposed.

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The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Exicure intends to use the net proceeds from the offering to advance AST-008 through a Phase 1b/2 clinical trial; to develop an SNA therapeutic candidate for a neurology condition and advance it into Phase 1 clinical trials; and for general corporate purposes.

Guggenheim Securities is acting as sole book-running manager for the offering.

The securities described above are being offered by Exicure pursuant to a shelf registration statement on Form S-3 (No. 333-230175) that was declared effective by the Securities and Exchange Commission (SEC) on July 24, 2019. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting: Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On July 30, 2019 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that it will release its financial results for second quarter 2019 before the start of trading on Tuesday, Aug. 6, 2019 (Press release, Quanterix, JUL 30, 2019, View Source [SID1234537910]). Company management will host a conference call at 10 a.m., EDT to discuss Quanterix’ financial results and provide a business update. The call will be hosted by Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix.

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Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 7499384. A live webcast will be accessible on the investor relations section of Quanterix’ website: View Source The webcast will be available on the Company’s website for one year following completion of the call.

On July 30, 2019 CURE Media Group — which reaches over 1 million patients, survivors and caregivers across an industry-leading multimedia platform devoted solely to cancer updates and research — reported that it has launched a seven-episode discussion series featuring Steven Gallant, who shares his story of survival with stage 4 renal cell cancer (RCC), alongside Karl J. D’Silva, M.D., medical oncologist, hematologist and medical director at Lahey Cancer Center (Press release, CURE, JUL 30, 2019, View Source [SID1234537909]).

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

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"We are excited to launch this video series," said Michael J. Hennessy Jr., president of MJH Associates, Inc., parent company of CURE Media Group. "It is revitalizing to experience Gallant’s triumph over RCC as his story is shared with both D’Silva and the audience."

Throughout the series, Gallant and D’Silva discuss Gallant’s journey to overcome this aggressive and metastatic disease, specifically with cabozantinib treatment. The first episode delves into Gallant’s diagnosis with stage 4 RCC, and the following episodes explore a variety of effective measures to manage toxicities when treating RCC. Topics of the seven-episode series include advice for patients with RCC, as well as the impact of support networks and multidisciplinary care. The series goes beyond Gallant’s personal narrative with stage 4 RCC, as D’Silva offers insight into frontline treatment options, toxicity management with cabozantinib and the typical prognosis of RCC.

Offering advice to individuals who may find themselves in similar situations, Gallant noted, "Whenever you go to the hospital, you should be positive, never feel like a victim. That victim mentality just creates a negative flow in the body. So, I went thinking I had kidney stones. I didn’t think it was a big deal. And when they diagnosed me, as they did, I still really didn’t blink because I’m such a positive person. I just stayed positive, and I believed that whatever was going to happen was the way it was supposed to be. And as it happened, it was synchronistic because of how I ended up with (D’Silva) as a doctor."

"CURE Expert Connections" is a video platform designed specifically for patients with cancer featuring information, stories and advice about the cancer journey.

To view the complete video series, click here.

About CURE Media Group

CURE Media Group is the leading multimedia resource for cancer updates

On July 30, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its second quarter 2019 financial results after the market closes on Tuesday, August 13, 2019. In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights (Press release, Personalis, JUL 30, 2019, View Source [SID1234537908]).

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Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 5981178. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.