Nektar to Announce Financial Results for the Second Quarter 2019 on Thursday, August 8, 2019, After Close of U.S.-Based Financial Markets

On July 30, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported that it will announce its financial results for the second quarter on Thursday, August 8, 2019, after the close of U.S.-based financial markets (Press release, Nektar Therapeutics, JUL 30, 2019, View Source [SID1234537915]). Howard Robin, President and Chief Executive Officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Daylight Time/2:00 p.m. Pacific Daylight Time.

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The press release and a live 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, September 9, 2019.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Conference ID: 2879328 (Nektar Therapeutics is the host)

FDA approves Bayer’s Nubeqa® (darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer

On July 30, 2019 The U.S. Food and Drug Administration (FDA) reported that it approved Nubeqa (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) (Press release, Bayer, JUL 30, 2019, View Source [SID1234537914]).1 The FDA approval is based on the Phase III ARAMIS trial evaluating Nubeqa plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.0001).1 MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Nubeqa was approved under the FDA’s Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effectiveness of the treatment for serious conditions.

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"Patients at this stage of prostate cancer typically don’t have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy," said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center. "This approval marks an important new option for the prostate cancer community."

In the U.S., over 73,000 men are estimated to be diagnosed with castration-resistant prostate cancer (CRPC) in 2019.2 About 40 percent of these patients have prostate cancer that has not spread to other parts of the body and is also associated with a rising prostate-specific antigen (PSA) level, despite a castrate testosterone level, which is known as nmCRPC.2,3 This is important because about one-third of men with nmCRPC go on to develop metastases within two years.4 PSA monitoring is important to identify patients and help offset undertreatment in men before the disease spreads.5,6

"We know that men with nmCRPC are still in the prime of their lives and are at a critical point in their disease when action needs to be taken," said Howard R. Soule, Ph.D., Executive Vice President and Chief Science Officer, Prostate Cancer Foundation (PCF). "For 26 years, PCF has been focused on research aimed at improving patient outcomes and we welcome the addition of new treatment options that provide men with more choices when working with their doctor to select what’s right for them."

"With the approval of Nubeqa, we now have a new therapy that extends MFS and allows physicians greater flexibility to treat men living with nmCRPC," said Robert LaCaze, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. "Bayer is proud to take this latest step forward in the nmCRPC treatment landscape. Nubeqa is the newest addition to our prostate cancer portfolio and reflects Bayer’s commitment to finding treatments for men at different stages along the prostate cancer continuum."

In the ARAMIS trial, both arms showed a 9 percent discontinuation rate due to adverse reactions.1 The most frequent adverse reactions requiring discontinuation in patients who received Nubeqa included cardiac failure (0.4 percent), and death (0.4 percent).1 Adverse reactions occurring more frequently in the Nubeqa arm (≥2 percent over placebo) were fatigue (16 percent versus 11 percent), pain in extremity (6 percent versus 3 percent) and rash (3 percent versus 1 percent).1 Nubeqa was not studied in women and there is a warning and precaution for embryo-fetal toxicity.1

Overall survival (OS) and time to pain progression were additional secondary efficacy endpoints.1 OS data were not yet mature at the time of final MFS analysis.1 The MFS result was supported by a delay in time to pain progression, defined as at least a 2-point worsening from baseline of the pain score on Brief Pain Inventory-Short Form or initiation of opioids, in patients treated with Nubeqa as compared to placebo.1 Pain progression was reported in 28 percent of all patients on study.1

Bayer has filed for approval of Nubeqa in the European Union (EU), Japan, and with other health authorities. Nubeqa is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

Nubeqa will be available in oral tablets for adults.1 For more information, visit www.NUBEQA.com.

Value Program for Nubeqa Patients
Bayer is committed to ensuring that patients in the U.S. who are prescribed Nubeqa can access the medication and receive the support they may need. As part of this commitment, Bayer is launching an innovative patient support program, DUDE (Darolutamide User Drug Experience) Access Services, which offers a two-month Free Trial Program to eligible patients along with a $0 co-pay for commercially insured patients who qualify. To learn more about these and other services, please visit the website or call 1-833-337-DUDE (1-833-337-3833) available Monday-Friday, 9:00am-7:00pm EST.

Clinical Trial Results
The FDA approval of Nubeqa (darolutamide) is based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral Nubeqa in patients with nmCRPC who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of Nubeqa orally twice daily or placebo plus ADT. Patients with a history of seizure were allowed in the study.1

The primary efficacy endpoint of the trial was MFS, defined as the time from randomization to the time of first evidence of BICR-confirmed distant metastasis or death due to any cause within 33 weeks after the last evaluable scan, whichever occurred first.1 Nubeqa plus ADT demonstrated a statistically significant improvement in MFS, with a median MFS of 40.4 months versus 18.4 months with placebo plus ADT [HR=0.41, 95% CI (0.34, 0.50), p<0.0001].1 OS and time to pain progression were additional secondary efficacy endpoints.1 OS data were not yet mature at the time of final MFS analysis.1 The MFS result was supported by a delay in time to pain progression, defined as at least a 2-point worsening from baseline of the pain score on Brief Pain Inventory-Short Form or initiation of opioids, in patients treated with Nubeqa as compared to placebo.1 Pain progression was reported in 28 percent of all patients on study.1

Adverse reactions occurring more frequently in the Nubeqa arm (≥2 percent over placebo) were fatigue (16 percent versus 11 percent), pain in extremity (6 percent versus 3 percent) and rash (3 percent versus 1 percent).1 The only observed adverse reaction in ≥10 percent of patients receiving Nubeqa was fatigue.1 Additionally, clinically significant adverse reactions occurring in 2 percent or more of patients treated with Nubeqa included ischemic heart disease (4.0 percent versus 3.4 percent on placebo) and heart failure (2.1 percent versus 0.9 percent on placebo).1 Discontinuation due to adverse reactions occurred in 9 percent of patients in both arms of the study.1 The most frequent adverse reactions requiring discontinuation in patients who received Nubeqa included cardiac failure (0.4 percent), and death (0.4 percent).1 Dose interruptions due to an adverse reaction occurred in 13 percent of patients treated with Nubeqa.1 The most frequent adverse reactions requiring dosage interruption in patients who received Nubeqa included hypertension (0.6 percent), diarrhea (0.5 percent), and pneumonia (0.5 percent).1 Dose reductions due to an adverse reaction occurred in 6 percent of patients treated with Nubeqa.1 The most frequent adverse reactions requiring dosage reduction in patients treated with Nubeqa included fatigue (0.7 percent), hypertension (0.3 percent), and nausea (0.3 percent).1

About Nubeqa (darolutamide)
Nubeqa (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.1 Nubeqa is approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1 A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about this trial can be found at www.clinicaltrials.gov.

Bayer has submitted filings for darolutamide in the European Union (EU), Japan, and additional countries.

About Prostate Cancer
Prostate cancer is the second most commonly diagnosed malignancy and fifth leading cause of cancer in men worldwide.7 In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide.7 Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system.8 It mainly affects men over the age of 50, and the risk increases with age.9 Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.10 However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.11

Castration-resistant prostate cancer (CRPC) is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly, but until two years ago, there have been no FDA-approved treatment options for CRPC patients who have prostate cancer that has not spread to other parts of the body with rising prostate-specific antigen (PSA) levels despite a castrate testosterone level, which is called non-metastatic castration-resistant prostate cancer, or nmCRPC.6,12 About one-third of men with nmCRPC go on to develop metastases within two years.4 In men with progressive nmCRPC, a short PSA doubling time is correlated with shortened time to first metastasis and death.12

IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥ 1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (≥ 2% over placebo) were fatigue (16% vs. 11%), pain in extremity (6% vs. 3%) and rash (3% vs. 1%).

Clinically significant adverse reactions occurring in ≥ 2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs. 3.4% on placebo) and heart failure (2.1% vs. 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure, which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure, which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of breast cancer resistance protein (BCRP) transporter. Concomitant use of NUBEQA increases the exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug. Consult the approved product labeling of the BCRP substrate when used concomitantly with NUBEQA.

For important risk and use information about Nubeqa, please see the full Prescribing Information.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

Veracyte Announces Second Quarter 2019 Financial Results

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

Exicure Announces Proposed Public Offering of Common Stock and Uplisting to Nasdaq Capital Market

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.

Quanterix to Release Second Quarter 2019 Financial Results and Host Conference Call on Tuesday, August 6, 2019

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.