On February 5, 2019 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal second-quarter 2019, provided an update on recent business highlights, maintained its fiscal year 2019 financial guidance and provided fiscal third-quarter 2019 financial guidance (Press release, Myriad Genetics, FEB 5, 2019, View Source [SID1234533067]).

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"This quarter we saw a return to revenue growth for our hereditary cancer business, an acceleration in our prenatal testing and continued profitability improvements driven by the Elevate 2020 program," said Mark C. Capone, president and CEO, Myriad Genetics. "Importantly, in the last month, we announced two pivotal events with the publication of the GeneSight GUIDED study and the launch of our expanded Women’s Health sales team, which have the potential to drive transformational growth and long-term shareholder value."

Business Highlights

Hereditary Cancer

Revenue returned to growth for the first time since fiscal year 2014.

Achieved eighth consecutive quarter of year-over-year hereditary cancer testing volume growth and fifth consecutive quarter with stable hereditary cancer pricing.

Presented validation study on riskScore for women of Hispanic descent at the 2018 San Antonio Breast Cancer Symposium, consisting of almost 9,000 women analyzed with a proprietary test that was highly predictive of breast cancer risk (p= 7.1 x 10-19).

Submitted our application to the Japanese Ministry of Health, Labour, and Welfare, for BRACAnalysis in hereditary cancer patients. There are approximately 3 million women in Japan who will be candidates for this test if approved.

GeneSight

GeneSight test volume increased 22 percent year over year.

GeneSight revenue was negatively impacted by changes in Medicare documentation requirements and the impact on cash collections from recently implemented industry-wide laboratory benefit manager programs.

A record 16,000 physicians ordered a GeneSight test in the fiscal second quarter.

Published the landmark GUIDED study in the Journal of Psychiatric Research, which is the largest prospective pharmacogenomics study ever conducted in depression. The key finding of the study was that patients were 50 percent more likely to achieve remission and 30 percent more likely to respond to treatment when their medication selection was guided by the GeneSight test.

Prenatal Testing

Prenatal testing volume increased at a double-digit rate year-over-year with total revenue increasing 12 percent sequentially.

Completed sales force expansion in early January, tripling the number of sales representatives selling prenatal tests.

Launched Myriad Complete application which includes patient education, cost estimators, test results, electronic reporting, and counseling tools for physician and patient customers, covering all Myriad Women’s Health products including myRisk Hereditary Cancer.

Published a large clinical utility study for ForeSight in Genetics in Medicine. The study found that the ForeSight test led to significant changes in pregnancy management with 77 percent of at-risk couples taking steps to avoid having an affected offspring such as prenatal

diagnostic testing and in-vitro fertilization.

Vectra

Fiscal second-quarter revenue increased six percent year over year to $11.8 million.

Published study in Rheumatology demonstrating that Vectra was five times more predictive of radiographic progression compared to historical measures of disease activity.

Prolaris

Fiscal second-quarter revenue increased 45 percent year-over-year to $6.1 million.

EndoPredict

Fiscal second-quarter revenue increased 10 percent year-over-year to $2.2 million.

Received favorable National Comprehensive Cancer Network Guidelines.

Received a favorable recommendation from NICE in the United Kingdom providing reimbursement coverage for the test.

Presented data at the San Antonio Breast Cancer Symposium (SABCS) from a retrospective study with 3,746 women that evaluated the benefit of chemotherapy on 10-year distant recurrence in women with estrogen receptor positive, HER2 negative breast cancer. The study found that women with a high EndoPredict score who received chemotherapy saw a statistically significant benefit with lower rates of 10-year distant recurrence compared to high risk women who did not receive chemotherapy.

A second study presented at SABCS evaluated the distant recurrence rates in 1,702 women who received five years of endocrine therapy alone and were followed for 15 years. This study showed a four-fold risk of recurrence in the 5 to 15 year timeframe for women with a high EndoPredict score and demonstrates EndoPredict can identify women who will benefit from extended endocrine therapy.

A third, 373 patient study was presented at SABCS that is positioned to corroborate the ability of EndoPredict to predict chemotherapy benefit. This is the first prospective study to ever evaluate chemoprediction in a high-risk cohort for any breast cancer recurrence test. In a 3-year interim evaluation of the data, high-risk patients who received chemotherapy had a disease free recurrence rate of 96.3 percent compared to 91.5 percent in the high-risk patients who did not receive chemotherapy (p=0.06).

Companion Diagnostics

Received U.S. Food and Drug Administration approval for BRACAnalysis CDx for use in conjunction with olaparib for maintenance in first-line ovarian cancer.

Completed our submission in Japan for BRACAnalysis CDx as a companion diagnostic in first line ovarian cancer with olaparib.

Fiscal Year 2019 and Fiscal Third-Quarter 2019 Financial Guidance

Myriad’s fiscal year 2019 and third-quarter 2019 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 second-quarter financial results and fiscal year 2019 financial guidance.

Conference Call and Webcast

A conference call will be held today, Tuesday, February 5, 2019, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal second-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-888-222-6159. International callers may dial 1-303-223-4369. All callers will be asked to reference reservation number 21914704. 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 February 5, 2019 Sanofi reported that the pivotal Phase 3 trial of isatuximab in patients with relapsed/refractory multiple myeloma met the primary endpoint of prolonging progression free survival in patients treated with isatuximab in combination with pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone alone (standard of care) (Press release, Sanofi, FEB 5, 2019, View Source [SID1234533065]).

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Results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year.

"We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients," said John Reed, Head of Research and Development at Sanofi. "We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible."

Multiple myeloma is the second most common hematologic malignancy[1], with more than 138,0002 new cases worldwide each year. Multiple myeloma remains incurable in the vast majority of patients, resulting in significant disease burden.

The randomized, multi-center, open label Phase 3 study, known as ICARIA-MM, enrolled 307 patients with relapsed/refractory multiple myeloma across 96 centers spanning 24 countries. All study participants received two or more prior anti-myeloma therapies, including at least two consecutive cycles of lenalidomide and a proteasome inhibitor given alone or in combination. During the trial, isatuximab was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment. The safety profile was evaluated as a secondary endpoint.

About isatuximab clinical development program

Isatuximab targets a specific epitope of CD38 capable of triggering multiple, distinct mechanisms of action that are believed to promote programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on multiple myeloma cells and is a cell surface receptor target for antibody-based therapeutics in multiple myeloma and other malignancies. The clinical significance of these findings is under investigation.

ICARIA-MM is one of four ongoing Phase 3 clinical trials evaluating isatuximab in combination with currently available standard treatments for people with relapsed/refractory or newly-diagnosed multiple myeloma.

Isatuximab received orphan designation for relapsed/refractory multiple myeloma by the U.S. Food and Drug Administration and the European Medicines Agency. Isatuximab is an investigational agent and the safety and efficacy has not been evaluated by the U.S. Food and Drug Administration, the European Medicines Agency, or any other regulatory authority. Isatuximab is also under investigation for the treatment of other hematologic malignancies and solid tumors.

On February 5, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune disease, asthma and allergic disease, and cancer, reported it has entered into a research and license agreement with Genentech, a member of the Roche Group, to develop and commercialize novel IL-15 cytokine therapeutics, including XmAb24306. XmAb24306 is an IL-15/IL-15Rα cytokine complex engineered with Xencor’s bispecific Fc domain and Xtend Fc technology and is Xencor’s most advanced preclinical cytokine program (Press release, Xencor, FEB 5, 2019, View Source [SID1234533064]).

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"This partnership with Genentech accelerates our immuno-oncology work by enabling the exploration of novel XmAb24306 combinations with Genentech’s leading oncology portfolio and our growing internal pipeline of bispecific antibodies," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "A wide-ranging combination strategy will be critical to realize the potential of IL-15 bispecific cytokines such as XmAb24306, so we plan to explore our cytokines with a broad spectrum of leading commercial-stage and investigational cancer therapies."

"We believe cytokine therapy will play an important role in the treatment of a wide range of diseases, including cancer," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "This collaboration with Xencor will further enhance our understanding of a critical immune activation pathway and may present a potential new way to use the immune system to target cancer."

IL-15 is a highly active cytokine, or immune signaling protein, that when pre-complexed with IL-15 receptor alpha (IL-15Rα) will bind to IL-15Rβγ and stimulate the expansion and activation of natural killer (NK) cells and cytotoxic T cells, but with reduced regulatory T cell activation compared to IL-2. Xencor’s IL-15 bispecific cytokine platform provides a more druggable version of IL-15 with potentially superior tolerability, slower receptor-mediated clearance and a prolonged half-life, and is intended for development with a wide range of combination agents due to its proposed mechanism of activating tumor-killing immune cells.

Under the terms of the agreement, the companies will co-develop XmAb24306 and other potential IL-15 programs, in which the companies will share development costs and profits. Genentech will commercialize medicines worldwide, and Xencor has the option to co-promote in the United States. Additionally, the companies will engage in a two-year research program to discover new IL-15 drug candidates, including ones targeted to specific immune cell populations. Genentech will pay Xencor $120 million upfront, and Xencor will be eligible to receive up to $160 million in development milestones for the XmAb24306 program and up to $180 million in development milestones for each new IL-15 drug candidate.

The agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and closing is expected to occur in the first half of 2019

On February 5, 2019 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it has priced an underwritten public offering of 28,000,000 American Depositary Shares ("ADSs"), each representing one of its ordinary shares, and warrants to purchase 28,000,000 ADSs, at a public offering price of $0.55 per ADS and accompanying warrant (Press release, BioLineRx, FEB 5, 2019, View Source;p=RssLanding&cat=news&id=2386087 [SID1234533062]). The warrants will be exercisable immediately, will expire five years from the date of issuance and will have an exercise price of $0.75 per ADS. The gross proceeds of the offering to the Company are expected to be $15.4 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by BioLineRx, and excluding the exercise of any warrants. All of the securities in the offering are to be sold by BioLineRx. The closing of the offering is expected to occur on or about February 7, 2019, subject to customary closing conditions. BioLineRx anticipates using the net proceeds from the offering for general corporate purposes, which may include, but are not limited to, working capital and funding clinical trials.

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Oppenheimer & Co. Inc. acted as sole book-running manager for the offering. Maxim Group LLC acted as co-manager for the offering.

The securities described above will be issued pursuant to a shelf registration statement (File No. 333-222332) that was previously filed with, and declared effective by, the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement related to the offering was filed with the SEC on February 4, 2019 and is available on the SEC’s website located at www.sec.gov. The final prospectus supplement related 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 final prospectus supplement may also be obtained, when available, from Oppenheimer & Co. Inc., 85 Broad St., 26th Floor, New York, New York 10004, Attention: Syndicate Prospectus Department, or by telephone: (212) 667-8055 or by email: [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy 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 any such state or jurisdiction.

On February 5, 2019 BerGenBio ASA (OSE:BGBIO), reported that it will announce its results for the fourth quarter and full year 2018 on Tuesday, 12 February 2019 (Press release, BerGenBio, FEB 5, 2019, View Source [SID1234533060]). A presentation by BerGenBio’s senior management team will take place at 10:00 am CET at:

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Hotel Continental
Stortingsgaten 24/26
0117 Oslo

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.