On July 23, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported completion of the three patient run-in for the AWARE-1 study in early-stage breast cancer combining pelareorep and Tecentriq (atezolizumab) (Press release, Oncolytics Biotech, JUL 23, 2019, View Source [SID1234537672]). All three patients demonstrated immunohistochemically positive viral replication in the tumor mass – two of the three patients showed greater than 50% of the tumor cells infected – following intravenous administration, generating inflammation and T cell recruitment at the tumor site. Increases in PD-L1 expression on tumor cells were noted in all patients, and early data suggest a correlation between T cell clonality and viral replication with highly infected tumors. Importantly, no additional side effects were observed with the combination of pelareorep and atezolizumab beyond those observed for each agent individually.

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"Data from the Tecentriq safety run-in support our hypothesis that pelareorep can enhance tumor inflammation not only in HR+/HER2- patients but also in triple-negative breast cancer patients, and we are pleased with the favorable recommendation from the Steering Committee to advance into the next phase of the AWARE-1 study," said Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "Importantly, our previously identified biomarker of higher peripheral T cell clonality appears to correlate with patients having the most productive viral infection. As the study continues, we expect data will provide further evidence of the role of pelareorep enhancing the inflammatory process and synergizing with checkpoint blockade."

"These observations are supportive of our previous findings of improved survival in metastatic breast cancer patients which will allow us to further refine our phase three registration study," said Dr. Matt Coffey, President, and CEO of Oncolytics Biotech. "While we have previously demonstrated tumor targeting following systemic delivery in the metastatic setting, these data provide the first evidence that pelareorep can be effectively delivered intravenously and target primary breast cancer. The implications for the treatment of breast cancer in multiple settings and with immune and targeted therapies are vast. We hope to announce interim data at a scientific conference before the end of the year."

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early stage breast cancer that will enroll 38 patients into five cohorts:

Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)

Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)

Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)

Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)

Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines the standard of care by breast cancer subtype with pelareorep and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer sub-type. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

The study is being coordinated by Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics’ Scientific Advisory Board.

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On July 23, 2019 Centene Corporation (NYSE: CNC) reported its financial results for the second quarter ended June 30, 2019, diluted earnings per share (EPS) of $1.18, and Adjusted Diluted EPS of $1.34 (Press release, CENTENE, JUL 23, 2019, View Source [SID1234537688]).

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In summary, the 2019 second quarter results were as follows:

(1) A full reconciliation of Adjusted Diluted EPS is shown beginning on page five of this release.

Diluted and Adjusted Diluted EPS for the second quarter of 2019 benefited from solid operating performance across our business segments, the net impact of the reconciliation of the 2018 risk adjustment program exceeding our expectations by $0.05 per diluted share and a gain related to the acquisition of Ribera Salud of $0.03 per diluted share.

Michael F. Neidorff, Centene’s Chairman, President and Chief Executive Officer, stated, "Our strong second quarter results demonstrate Centene’s favorable financial and operating momentum. Our pending WellCare acquisition will bolster and diversify our product offerings, significantly increase our scale and provide access to new markets – enhancing Centene’s long-term growth outlook."

Second Quarter Highlights

June 30, 2019 managed care membership of 15.0 million, an increase of 2.2 million members, or 17%, over June 30, 2018.
Total revenues for the second quarter of 2019 of $18.4 billion, representing 29% growth compared to the second quarter of 2018.
Health benefits ratio (HBR) of 86.7% for the second quarter of 2019, compared to 85.7% in the second quarter of 2018.
Selling, general and administrative (SG&A) expense ratio of 9.1% for the second quarter of 2019, compared to 9.6% for the second quarter of 2018.
Adjusted SG&A expense ratio of 9.0% for the second quarter of 2019, compared to 9.6% for the second quarter of 2018.
Diluted EPS for the second quarter of 2019 of $1.18, compared to $0.75 for the second quarter of 2018, an increase of 57%.
Adjusted Diluted EPS for the second quarter of 2019 of $1.34, compared to $0.90 for the second quarter of 2018, an increase of 49%.
Operating cash flow of $917 million for the second quarter of 2019, representing 1.9x net earnings.
Other Events

In July 2019, our Oregon subsidiary, Trillium Community Health Plan, was notified by the Oregon Health Authority (OHA) of its intent to award Trillium an expanded contract to serve as a coordinated care organization for six counties in the state. Pending successful completion of OHA’s readiness review and additional contract negotiations, the contract is scheduled to begin on January 1, 2020.
In June 2019, our Spanish subsidiary, Primero Salud, acquired additional ownership in Ribera Salud, increasing our ownership in the Spanish healthcare company from 50% to 90%.
In June 2019, all proposals regarding the pending acquisition of WellCare Health Plans, Inc. (WellCare) were approved by Centene and WellCare shareholders.
Accreditations & Awards

In July 2019, FORTUNE announced Centene’s position of #168 in its annual ranking of the largest companies globally by revenue.
In July 2019, Centene was recognized with a 100 percent score on the Disability Equality Index (DEI) as one of the Best Places to Work for People with Disabilities.
In May 2019, FORTUNE announced Centene’s position of #51 in its annual ranking of America’s largest companies by revenue.
In May 2019, Centene and several of its subsidiaries earned Accreditation from NCQA, including California Health & Wellness and Health Net Community Solutions.
Membership

Medicare includes Medicare Advantage, Medicare Supplement, Special Needs Plans, and MMP.

Statement of Operations: Three Months Ended June 30, 2019

For the second quarter of 2019, total revenues increased 29% to $18.4 billion from $14.2 billion in the comparable period in 2018. The increase over the prior year was primarily due to the acquisition of Fidelis Care, growth in the Health Insurance Marketplace business, expansions and new programs in many of our states in 2018 and 2019, particularly Arkansas, New Mexico, and Pennsylvania. These increases were partially offset by the health insurer fee moratorium in 2019.
Sequentially, total revenues decreased 1% from the first quarter of 2019 primarily due to significant pass through payments from the States of California and New York in the first quarter.
HBR of 86.7% for the second quarter of 2019 represents an increase from 85.7% in the comparable period in 2018. The increase was primarily attributable to the Health Insurance Marketplace business where margins have normalized, as expected, from the favorable performance in 2018. The increase was also due to the health insurer fee moratorium and the acquisition of Fidelis Care, which operates at a higher HBR.
HBR increased sequentially from 85.7% in the first quarter of 2019. The increase was primarily due to the normal seasonality in the Health Insurance Marketplace business.
The SG&A expense ratio was 9.1% for the second quarter of 2019, compared to 9.6% in the second quarter of 2018. The Adjusted SG&A expense ratio was 9.0% for the second quarter of 2019, compared to 9.6% in the second quarter of 2018. The SG&A and Adjusted SG&A expense ratios both decreased due to the acquisition of Fidelis Care, which operates at a lower SG&A expense ratio.
The effective tax rate was 25.7% for the second quarter of 2019, compared to 36.9% in the second quarter of 2018. The decrease in the effective tax rate was due to the impact of the health insurer fee moratorium.
Balance Sheet

At June 30, 2019, the Company had cash, investments and restricted deposits of $15.9 billion, including $801 million held by unregulated entities. Medical claims liabilities totaled $7.4 billion. The Company’s days in claims payable was 47 days, which is a decrease of one day over the first quarter of 2019. Total debt was $7.1 billion, which includes $513 million of borrowings on our $2.0 billion revolving credit facility at quarter end. The debt to capitalization ratio was 36.3% at June 30, 2019, excluding $158 million of non-recourse debt.

Outlook

The Company’s annual guidance for 2019 has been updated to reflect the second quarter performance and the reinvestment of $0.05 per diluted share in Centene Forward related initiatives in the second half of 2019.

Adjusted Diluted EPS excludes amortization of acquired intangible assets of $0.46 to $0.47 per diluted share and acquisition related expenses of $0.13 to $0.15 per diluted share.

Adjusted SG&A expense ratio excludes acquisition related expenses of $73 million to $84 million.

Conference Call

As previously announced, the Company will host a conference call Tuesday, July 23, 2019, at approximately 8:30 AM (Eastern Time) to review the financial results for the second quarter ended June 30, 2019. Michael Neidorff and Jeffrey Schwaneke will host the conference call.

Investors and other interested parties are invited to listen to the conference call by dialing 1-877-883-0383 in the U.S. and Canada; +1-412-902-6506 from abroad, including the following Elite Entry Number: 9467577 to expedite caller registration; or via a live, audio webcast on the Company’s website at www.centene.com, under the Investors section.

A webcast replay will be available for on-demand listening shortly after the completion of the call for the next twelve months or until 11:59 PM (Eastern Time) on Tuesday, July 21, 2020, at the aforementioned URL. In addition, a digital audio playback will be available until 9:00 AM (Eastern Time) on Tuesday, July 30, 2019, by dialing 1-877-344-7529 in the U.S. and Canada, or +1-412-317-0088 from abroad, and entering access code 10132753.

Non-GAAP Financial Presentation

The Company is providing certain non-GAAP financial measures in this release as the Company believes that these figures are helpful in allowing investors to more accurately assess the ongoing nature of the Company’s operations and measure the Company’s performance more consistently across periods. The Company uses the presented non-GAAP financial measures internally to allow management to focus on period-to-period changes in the Company’s core business operations. Therefore, the Company believes that this information is meaningful in addition to the information contained in the GAAP presentation of financial information. The presentation of this additional non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP.

Specifically, the Company believes the presentation of non-GAAP financial information that excludes amortization of acquired intangible assets and acquisition related expenses, as well as other items, allows investors to develop a more meaningful understanding of the Company’s performance over time. The tables below provide reconciliations of non-GAAP items ($ in millions, except per share data):

Other adjustments include the 2018 impact of retroactive changes to the California minimum medical loss ratio (MLR) of $30 million of expense.

The income tax effects of adjustments are based on the effective income tax rates applicable to adjusted (non-GAAP) results.

The amortization of acquired intangible assets per diluted share presented above is net of an income tax benefit of $0.04 and $0.02 for the three months ended June 30, 2019 and 2018, respectively, and $0.07 and $0.05 for the six months ended June 30, 2019 and 2018, respectively, and an estimated $0.14 for the year ended December 31, 2019.

The acquisition related expenses per diluted share presented above are net of an income tax benefit of $0.01 for the three months ended June 30, 2019, and $0.03 and $0.01 for the six months ended June 30, 2019 and 2018, respectively, and an estimated $0.05 for the year ended December 31, 2019.

Other adjustments include the 2018 impact of retroactive changes to the California MLR, which is net of an income tax benefit of $0.02 per diluted share for both the three and six months ended June 30, 2018.

On July 23, 2019 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report business results for the second quarter of 2019 after 5:00 p.m. ET on Tuesday, August 6, 2019 (Press release, Supernus, JUL 23, 2019, View Source;19.htm [SID1234537673]).

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Jack Khattar, President and Chief Executive Officer, and Greg Patrick, Chief Financial Officer, will host a conference call to present the second quarter 2019 business and financial results on Wednesday, August 7, 2019 at 9:00 a.m. ET. Following management’s prepared analysis and discussion of business results, the call will be open for questions.

A live webcast will be available at www.supernus.com.

Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

Conference dial-in:
(877) 288-1043
International dial-in:
(970) 315-0267
Conference ID:
1527779
Conference Call Name:
Supernus Pharmaceuticals Second Quarter 2019 Earnings Conference Call

Following the live call, a replay will be available on the Company’s website under the ‘Investors Relations’ section. The webcast will be available on the Company’s website for 60 days following the live call.

On July 23, 2019 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) reported the appointments of Elizabeth A. Tarka, MD, FACC as Chief Medical Officer and the promotion of John J. Kirby to Chief Financial Officer (Press release, Idera Pharmaceuticals, JUL 23, 2019, View Source [SID1234537674]). Dr. Tarka was most recently the Vice President of Clinical Development at Complexa, Incorporated. Mr. Kirby has led Idera’s finance department as Principal Financial Officer and Principal Accounting Officer since October 2018.

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"We are extremely pleased to bring Liz onto our team during this critical period for Idera as we advance tilsotolimod through its registrational trial in patients suffering from refractory metastatic melanoma and continue development work to bring the therapy to patients beyond melanoma," stated Vincent Milano, Idera’s Chief Executive Officer. "Throughout her career, Liz has demonstrated a strong track record of clinical development across therapeutic categories, which will benefit our company greatly as we work to deliver against our tilsotolimod objectives and as we also continue to aggressively explore growth opportunities in the rare disease space."

Dr. Tarka’s experience in the pharmaceutical and biotechnology industry includes leadership roles across all phases of late stage clinical development and reflects the ability to effectively partner with stakeholders to enable the successful execution of clinical trials. Prior to joining Complexa, she served as Clinical Program Leader for Xarelto (rivaroxaban) at Janssen Pharmaceuticals, where she was responsible for the design, implementation and medical oversight for large multinational trials. She also held various positions of increasing responsibility at GlaxoSmithKline in the Metabolic Pathways and Cardiovascular Therapeutic Area. She has been on the faculty and had numerous major teaching and clinical responsibilities at the University of Pennsylvania and affiliated hospitals. She is trained in Cardiology and Internal Medicine and has published in a number of peer-reviewed journals. Dr. Tarka earned a BA in Biochemistry and an MD from the University of Pennsylvania where she also completed her residency and fellowship training.

"I am excited to join the Idera team and continue to advance tilsotolimod through the ILLUMINATE-301 trial to understand the potential benefits of this novel approach in treating patients with anti-PD-1 refractory melanoma," stated Dr. Tarka. "I’m eager to work with this team to also realize the broader applications of tilsotolimod and identify additional rare disease assets to help drive the future growth of our company."

Mr. Kirby has been the Company’s Vice President of Finance since July 2018. Before joining Idera in 2015, Mr. Kirby served as Assistant Controller at Endo Pharmaceuticals. Prior to joining Endo, Mr. Kirby served as Vice President, Chief Accounting Officer and Corporate Controller at ViroPharma Incorporated. Mr. Kirby began his career at KPMG, LLP and served as a Regional Audit Director at AstraZeneca Pharmaceuticals prior to joining ViroPharma. Mr. Kirby received his Bachelor of Science from Villanova University and is a licensed certified public accountant.

"John has done a tremendous job leading our finance operations and team, and I am looking forward to continuing to work together with him as our Chief Financial Officer," continued Milano.

On July 23, 2019 Genmab A/S (Nasdaq: GMAB) reported the closing of the exercise in full by the underwriters of their over-allotment option in connection with its initial public offering of American Depositary Shares ("ADSs") in the United States (the "Offering") and the increase of its share capital by 427,500 ordinary shares as a consequence of the issuance of 427,500 ordinary shares (the "New Shares") with a nominal value of DKK 1 per share in the form of 4,275,000 ADSs in connection with the exercise (Press release, Genmab, JUL 23, 2019, View Source [SID1234537675]). The subscription price of DKK 1,181.80 per New Share equals the public offering price of $17.75 per ADS at the U.S. dollar/DKK exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of ten-to-one, and the gross total proceeds from the issuance of the New Shares amounts to US$75,881,250 (DKK 505.2 million).

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Following the registration of the New Shares today with the Danish Business Authority, Genmab’s share capital amounts to DKK 64,967,643 divided into 64,967,643 ordinary shares with a nominal value of DKK 1 each. The New Shares account for 0.7% of Genmab’s total share capital.

The New Shares rank pari passu with Genmab’s existing shares and carry the same dividend and other rights. Each New Share carries one vote at Genmab’s general meetings. Genmab only has one class of shares. The ADSs do not carry the same rights as Genmab’s ordinary shares and are not entitled to receive a dividend or vote as ordinary shares, except to the extent provided for through the depositary as record holder of the ordinary shares underlying the ADSs as set forth in the deposit agreement governing the ADSs.

Genmab’s ordinary shares were previously listed on Nasdaq Copenhagen under the symbol "GEN" and are now listed under the symbol "GMAB." The ADSs are listed on the Nasdaq Global Select Market under this symbol. The New Shares have been issued today and are expected to be admitted to trading and official listing on Nasdaq Copenhagen on July 24, 2019 with the permanent ISIN code DK0010272202.

The amendments to Genmab’s articles of association as a consequence of the registration of the New Shares have been registered today with the Danish Business Authority and have been published on Genmab’s website.

The registration statement on Form F-1 relating to the Offering was declared effective by the U.S. Securities and Exchange Commission on July 17, 2019.

BofA Merrill Lynch, Morgan Stanley and Jefferies acted as joint book-running managers for the Offering. Guggenheim Securities and RBC Capital Markets acted as joint lead-managers and Danske Markets, H.C. Wainwright & Co. and Kempen acted as co-managers for the Offering. A copy of the final prospectus relating to the Offering may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone: 1-877-821-7388, or by email: [email protected]. Copies of the final prospectus related to the Offering are also available at www.sec.gov. No Danish prospectus was issued or offered.

This Company Announcement does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.