On August 13, 2019 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported financial results for its fiscal fourth-quarter and full-year 2019, reported an update on recent business highlights and provided fiscal year and first-quarter 2020 financial guidance (Press release, Myriad Genetics, AUG 13, 2019, View Source [SID1234538763]).

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"Fiscal year 2019 revenue increased 14 percent with earnings up 18 percent. Unfortunately, revenue in the fourth quarter was two percent below expectations largely due to lower reimbursement for our expanded carrier screening test," said Mark C. Capone, president and CEO, Myriad Genetics. "Looking ahead to fiscal year 2020, with stabilized pricing, growing new product volumes and recent reimbursement advances with GeneSight, we are highly optimistic about our ability to deliver an inflection in revenue and earnings as we transition through the fiscal year."

Recent Business Highlights

Hereditary Cancer

Hereditary cancer revenue returned to year-over-year growth in fiscal year 2019 representing the first time hereditary cancer revenue has grown in the last five fiscal years.

Presented data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting from the Women’s Health Initiative study that evaluated mutation rates in 2,195 post-menopausal women with breast cancer. The study found that women with post-menopausal breast cancer had a high rate of inherited mutations in a range of cancer causing genes and this mutation rate did not diminish with age. This along with other studies have shown that

current hereditary breast cancer testing guidelines miss approximately 50 percent of mutation carriers.

GeneSight

Announced coverage decision from UnitedHealth, the largest commercial payer in the United States, covering GeneSight for patients that have a diagnosis of major depressive disorder or anxiety and have failed at least one prior medication.

Announced coverage decision for GeneSight by Kroger Prescription Plans. As part of the agreement, Kroger initiated an early access program at 500 Kroger pharmacies where GeneSight testing will be facilitated by the Kroger Health pharmacist.

Presented data at the Clinical Pharmacogenomics Implementation Consortium annual meeting showing GeneSight had more than double the predictive power for drug blood levels compared to single gene pharmacogenomics tests.

Completed a Medicare Coverage Advisory Committee meeting reviewing potential expansion of the GeneSight LCD to primary care physicians. During the meeting, Medicare’s selected subject matter experts unanimously agreed that pharmacogenomics testing should be available to primary care physicians.

Prolaris

Published data from a large study of 1,062 men with newly diagnosed localized prostate cancer to evaluate the ability of the Prolaris test to predict risk of metastases. The study found that Prolaris was the strongest independent predictor of progression to metastatic disease, and men were approximately three times more likely to develop metastatic disease with each unit increase in the Prolaris test score (HR: 2.93; p=1.8×10-11).

EndoPredict

Published data in the journal Clinical Cancer Research demonstrating that the EndoPredict test identifies women with early-stage breast cancer who can safely forgo extended endocrine therapy five years after diagnosis.

Published the results of the first comprehensive cost-effectiveness analysis of the EndoPredict test compared to other breast cancer assays. The study found that the EndoPredict test was more than twice as cost effective as Oncotype DX.

Companion Diagnostics

Announced that the BRACAnalysis CDx companion diagnostic test effectively identified patients with metastatic pancreatic cancer who benefitted from treatment with Lynparza

(olaparib) in the Phase III POLO study. Patients in the study with a germline mutation had a clinically-meaningful and statistically-significant improvement in progression-free survival (PFS) of 7.4 months when treated with Lynparza compared to 3.8 months for placebo (HR 0.53; p=0.004).

Received approval from the Japanese Ministry of Health, Labour, and Welfare for Myriad’s BRACAnalysis Diagnostic System as a companion for Lynparza in women with ovarian cancer.

Announced that BRACAnalysis CDx effectively identified patients with castrate resistant, metastatic prostate cancer who benefitted from treatment with Lynparza in the PROfound study. Results from the study showed a statistically-significant and clinically-meaningful improvement in radiographic progression-free survival in patients who received Lynparza vs. enzalutamide or abiraterone and had deleterious mutations in the BRCA1/2 genes.

myPath Melanoma

Received a positive final local coverage decision from Noridian Healthcare Solutions for myPath Melanoma.

German Clinic Sale

Announced planned sale of the Privatklinik Dr. Robert Schindlbeck GmbH & Co. KG (the "Clinic"), which is expected to occur around the middle of fiscal year 2020.

Fiscal Year 2020 and Fiscal First-Quarter 2020 Financial Guidance

Myriad’s fiscal year 2020 and first-quarter 2020 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The company will provide further details on its business outlook during the conference call today and discuss the fiscal fourth-quarter financial results and fiscal year 2020 financial guidance.

Conference Call and Webcast

A conference call will be held today, Tuesday, August 13, 2019, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal fourth-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-763-5615. International callers may dial 1-212-231-2936. All callers will be asked to reference reservation number 21927089. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.

On August 13, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission (EC) has approved variations to broaden the use of Imbruvica (ibrutinib) in two indications (Press release, Johnson & Johnson, AUG 13, 2019, View Source [SID1234538653]). This includes the use of ibrutinib in combination with obinutuzumab in adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and the use of ibrutinib plus rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). The approval follows the Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 28 June 2019.

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"The data supporting both the CLL and WM approvals show significant improvements in progression free survival with the use of ibrutinib-based therapy versus the standard of care study comparators respectively," said Dr Alessandra Tedeschi, Medical Director, Department of Hematology, Niguarda Hospital, Milan, Italy, and investigator in both the iNNOVATE and iLLUMINATE studies. "These approvals therefore provide healthcare professionals with new chemotherapy-free options for patients with these complex blood cancers."

The approval in CLL was based on results from the Phase 3 iLLUMINATE (PCYC-1130) study, published in The Lancet Oncology, which investigated ibrutinib in combination with obinutuzumab versus chlorambucil plus obinutuzumab in patients with previously untreated CLL.1

In WM, the decision was based on data from the Phase 3 iNNOVATE (PCYC-1127) study, published in the New England Journal of Medicine.2 The study evaluated the efficacy and safety of ibrutinib in combination with rituximab, versus rituximab with placebo, in patients with previously untreated and relapsed/refractory WM.3

Additional information about both studies can be found at www.ClinicalTrials.gov (NCT02264574 and NCT02165397).4,5

"With five European Commission approvals in five years, this latest EC decision further extends the potential reach and impact ibrutinib can have for patients," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "We remain committed to a comprehensive clinical development programme for ibrutinib, including exploring its use in other combinations, to address the needs of more and more patients with B-cell malignancies."

Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

Dr Alessandra Tedeschi is co-investigator in both the iNNOVATE and iLLUMINATE studies. She was not compensated for any media work.

#ENDS#

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.6 By blocking this BTK protein, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.7

Ibrutinib is currently approved in Europe for:8

Chronic lymphocytic leukaemia (CLL): As a single agent or in combination with obinutuzumab for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy
Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL
Waldenström’s macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients
Ibrutinib is approved in more than 95 countries, and, to date, has been used to treat more than 158,000 patients worldwide across its approved indications.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.8

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.9 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.10 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.11

The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

About Waldenström’s macroglobulinemia
Waldenström’s macroglobulinemia (WM) is a rare form of non-Hodgkin’s lymphoma (NHL).12 It causes overproduction of a protein called monoclonal immunoglobulin M (IgM) antibody, which causes a thickening of the blood.13 Incidence rates among men and women in Europe are approximately 7.3 and 4.2 per million persons, respectively.14 The causes of WM are unknown, with it typically affecting older adults and being slightly more common in men than women.12,14

On August 13, 2019 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), an immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported its financial results for the second quarter ended June 30, 2019 and is providing a business update for the year-to-date (Press release, INmune Bio, AUG 13, 2019, View Source [SID1234538726]).

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2019 Year-to-Date Corporate Highlights:

·INmune Bio’s management team rang the NASDAQ closing bell on Tuesday, April 9, 2019, to celebrate the Company’s successful initial public offering ("IPO") in February 2019.
·In May, the Company closed a private placement of approximately $4.7M of Common Stock priced led by Insiders and existing shareholders.
·The Company published data on INmune Bio’s INB16 (INKmune) cell line in peer-reviewed journal PLOS ONE.
·Reported positive preliminary data from INB03 Phase I clinical trial in cancer followed by a final report later this year as the Company advances the program into a Phase II study.
·Edguardo (Ed) Baracchini a biotech business development veteran joined the board of directors.

"This year we remained focused on advancing our pipeline," stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. "More recently we announced we have begun planning a Phase II trial for INB03 after receiving positive preliminary data from its clinical Phase I study. This preliminary data has allowed us to move forward with the development of INB03 as a combination immunotherapy for patients with cancer. We anticipate our full data set to be reported later this year followed by a Phase II study."

Our clinical programs continue to advance:

·Received preliminary positive data on INB03’s Phase I study in patients with advanced solid tumors. The trial was successful in determining, in order of priority, the safety of INB03 in cancer patients, the adequate dosage of INB03, and evidence of a biologic effect, as the Company begins planning a Phase II trial in cancer patients using INB03 as part of their combination immunotherapy. The target INB03 trough level was reached in three of three patients in the 1.0 mg/kg group. The inflammatory cytokine IL6, a biomarker of soluble TNF function, decreased by more than 50% in half of the patients, suggesting a pharmacodynamic effect of INB03.

·INmune anticipates it will start patient enrollment in the Phase I study of XPro1595 for the treatment of Alzheimer’s disease and INKmune, INmune Bio’s NK cell therapy focused on eliminating residual disease after cancer therapy, in the second half of 2019.

Financial Results for the Second Quarter Ended June 30, 2019:

Net loss attributable to common stockholders for the second quarter ended June 30, 2019 was $0.4 million, compared to $6.2 million for the quarter ended June 30, 2018. Net loss incurred during the quarter ended June 30, 2019 included a noncash waiver of common stock issuable of $1.5 million partially offset by noncash stock-based compensation expense of $1.0 million.

Research and development expense totaled approximately $0.3 million for the second quarter ended June 30, 2019, compared with approximately $0.3 million for the quarter ended June 30, 2018. During the three months ended June 30, 2019, research and development expense included $0.6 million of research and development expense related to clinical trials, partially offset by $0.3 million of grants from the Alzheimer’s Association which the Company recognized as contra research and development expense.

General and administrative expense was approximately $1.7 million in the quarter ended June 30, 2019, compared to approximately $5.9 million in the quarter ended June 30, 2018. The $4.2 million decline in general and administrative expense is due to lower noncash stock-based compensation ($1.0 million for the quarter ended June 30, 2019 compared to $5.6 million for the quarter ended March 31, 2018), partially offset by higher general and administrative expenses including investor relations and payroll expense.

At June 30, 2019, the Company had cash and cash equivalents of approximately $9.4 million with no debt. In May, the Company closed a private placement of approximately $4.7 million of Common Stock led by insiders and existing shareholders.

As of August 9, 2019 the Company had 10.8 million common and 13.9 million fully diluted shares outstanding.

On August 13, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, reported recent achievements the company has completed as a part of the company’s overall strategy to expand its clinical development programs and bring its lead drug candidate, Oncoprex immunogene therapy, to commercialization (Press release, Genprex, AUG 13, 2019, View Source [SID1234538654]).

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These recent achievements are outlined in the company’s newly launched, interactive corporate timeline, which can be found on Genprex’s website.

"Since Genprex’s IPO last year, we have made significant progress in many areas of the company, including progress toward expansion of our clinical programs and sponsored research, our manufacturing process development and scalability, and the growth of our team to support these initatives," said Rodney Varner, Chairman and Chief Executive Officer of Genprex. "These accomplishments have set the stage for us to continue on our path of growth and expansion, enabling our efforts to bring our drug candidate to market for lung cancer patients who cannot benefit from today’s therapies."

Genprex’s updates to ongoing activities, include:

Q2 2019

Announced positive pre-clinical findings from MD Anderson Cancer Center Sponsored Research Agreement studying the effects of TUSC2 with pembrolizumab at American Association of Cancer Research meeting
Developed Oncoprex and immunotherapy combination clinical trial design
Collaborated with Addison Whitney for drug nomenclature branding program and submission of non-proprietary drug name selections
Initiated manufacturing process development with key manufacturing partners to support clinical expansion and manufacturing scale-up processes
Completed manufacturing of TUSC2 DNA plasmid to support clinical trial ramp-up
Q1 2019

Appointed Key Staff: Senior Director of Pharmaceutical Sciences and Manufacturing and Senior Manager of Communications and Marketing
USPTO issued two additional patents to add to our intellectual property portfolio
Identified potential new clinical sites for expansion of Oncoprex and erlotinib combination clinical trial
Q4 2018

Appointed Key Staff: VP of Clinical Operations
Completion of clinical data reconciliation within a CDISC/SDTM-compliant database
Q3 2018

Initiated clinical site selection and expansion program with CRO partner
Initialization of sponsored pre-clinical research with MD Anderson Cancer Center to evaluate TUSC2 with immunotherapies including immune checkpoint inhibitors anti-PD1 and CTLA-4
Q2 2018

Continued execution and enhancement of strategy for manufacturing technology transfer and scale-up initiatives
Genprex’s new interactive timeline on its website shares additional historical achievements, where visitors can follow the company’s success since its inception.

On August 13, 2019 KIYATEC, Inc. reported that Capital Health has joined its U.S. clinical trial, 3D-PREDICT, to validate the company’s test as a patient-specific predictor of response to cancer therapies in glioblastoma (GBM) and anaplastic astrocytoma (AA) patients (Press release, KIYATEC, AUG 13, 2019, View Source [SID1234538655]). Capital Health is currently the only healthcare system in New Jersey, Pennsylvania and the New York City region enrolling GBM patients in the study.

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"Capital Health is committed to improving the health and well-being of our patients, while making the care we provide as personalized as possible. Taking part in this clinical trial underscores our mission to provide the best care, for each individual patient, at the earliest possible time," said Dr. Navid Redjal, director of Neurosurgical Oncology at Capital Health, and lead investigator of the study. "In oncology treatment, and especially for our patients with glioblastoma, being able to predict if a treatment will be successful has the potential to truly change patient care, particularly when time is of the essence."

3D-PREDICT is a prospective, open-label, multi-institutional, non-interventional study to validate KIYATEC’s EV3D platform for clinical use and to investigate the impact on outcomes for cancer patients with both newly diagnosed and recurrent epithelial ovarian cancer and recurrent high-grade gliomas. KIYATEC’s EV3D cell culture platform utilizes live cancer cells derived from surgical or biopsy tissue to create a patient specific in vivo-like tumor and immune microenvironment. The tumor and immune microenvironment are used to accurately model and assess responses from both investigational and approved cancer therapies. The study is anticipated to continue through 2020. Details on the trial can be found on View Source

"The continued growth of patient enrollment with the addition of Capital Health is a true testament to the value that oncology clinical teams realize in being able to better determine a viable treatment path for their patients at the earliest possible time," said Matthew Gevaert, CEO of KIYATEC. "We are realizing tremendous momentum, both with our ongoing clinical trial as well as recent publication of the positive results of our ovarian cancer study in the Nature journal Scientific Reports. This is a truly exciting time in the company’s growth as we continue on our path to provide a more personalized cancer treatment experience for patients."