Samus Therapeutics to Present at BIO CEO & Investor Conference

On February 4, 2020 Samus Therapeutics, Inc. ("Samus" or the "Company"), a privately held, Boston-based, biopharmaceutical company developing epichaperome inhibitors to intervene in pathological processes and initiate the degradation of disease-associated proteins, reported that Dick Bagley, President and Interim Chief Executive Officer, will present at the BIO CEO & Investor Conference in New York on Tuesday, February 11 at 9:15 a.m. ET (Press release, Samus Therapeutics, FEB 4, 2020, View Source;investor-conference-300998025.html [SID1234553850]).

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Aflac Incorporated Announces Fourth Quarter Results, Reports Fourth Quarter Net Earnings of $782 Million, 2019 Adjusted EPS In Line With Upwardly Revised Guidance, Affirms 2020 Adjusted EPS Outlook, Increases First Quarter Cash Dividend 3.7%

On February 4, 2020 Aflac Incorporated (NYSE: AFL) reported its fourth quarter results (Press release, Aflac, FEB 4, 2020, View Source [SID1234553849]).

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Total revenues were $5.6 billion during the fourth quarter of 2019, compared with $5.1 billion in the fourth quarter of 2018. Net earnings were $782 million, or $1.06 per diluted share, compared with $525 million, or $0.69 per diluted share a year ago.

Net earnings in the fourth quarter of 2019 included pretax net realized investment gains of $34 million, or $0.05 per diluted share, compared with pretax net losses of $322 million, or $0.42 per diluted share a year ago. Included in those net gains were $9 million of losses related to impairments and loan loss reserve changes. Pretax net realized gains also included $36 million in gains from changes in the fair value of equity securities and $10 million of losses from certain derivatives and foreign currency activities, as well as a $17 million gain from sales and redemptions.

The average yen/dollar exchange rate* in the fourth quarter of 2019 was 108.79, or 3.8% stronger than the average rate of 112.87 in the fourth quarter of 2018. For the full year, the average exchange rate was 109.07, or 1.2% stronger than the rate of 110.39 a year ago.

Adjusted earnings* in the fourth quarter were $756 million, compared with $779 million in the fourth quarter of 2018, reflecting a decrease of 3.0%. Adjusted earnings per diluted share* increased 1.0% to $1.03 in the quarter and included $3 million of pretax variable investment income on alternative investments, in line with the company’s expectations. The stronger yen/dollar exchange rate impacted adjusted earnings per diluted share by $0.02. Adjusted earnings per diluted share excluding the impact of foreign currency* decreased 1.0% to $1.01.

For the full year of 2019, total revenues were up 2.5% to $22.3 billion, compared with $21.8 billion for the full year of 2018. Net earnings were $3.3 billion, or $4.43 per diluted share, compared with $2.9 billion, or $3.77 per diluted share, for the full year of 2018. Adjusted earnings for the full year of 2019 were $3.3 billion, or $4.44 per diluted share, compared with $3.2 billion, or $4.16 per diluted share, in 2018. Adjusted earnings also included $32 million of pretax variable investment income on alternative investments, of which $21 million was above the company’s expectations. The stronger yen/dollar exchange rate impacted adjusted earnings per diluted share by $0.02.

Total investments and cash at the end of December 2019 were $138.1 billion, compared with $126.2 billion at December 31, 2018. In the fourth quarter, Aflac Incorporated repurchased $470 million, or 8.9 million of its common shares. For the full year, Aflac repurchased $1.6 billion, or 32.0 million of its common shares. At the end of December, the company had 37.1 million remaining shares authorized for repurchase.

Shareholders’ equity was $29.0 billion, or $39.84 per share, at December 31, 2019, compared with $23.5 billion, or $31.06 per share, at December 31, 2018. Shareholders’ equity at the end of the fourth quarter included a net unrealized gain on investment securities and derivatives of $8.5 billion, compared with a net unrealized gain of $4.2 billion at December 31, 2018. Shareholders’ equity at the end of the fourth quarter also included an unrealized foreign currency translation loss of $1.6 billion, compared with an unrealized foreign currency translation loss of $1.8 billion at December 31, 2018. The annualized return on average shareholders’ equity in the fourth quarter was 10.7% and 12.6% for the full year.

Shareholders’ equity excluding AOCI* was $22.3 billion, or $30.74 per share at December 31, 2019, compared with $21.3 billion, or $28.22 per share, at December 31, 2018. The annualized adjusted return on equity excluding foreign currency impact* in the fourth quarter was 13.4% and 15.1% for the full year.

AFLAC JAPAN

In yen terms, Aflac Japan’s net premium income was ¥345.8 billion for the quarter, or 1.6% lower than a year ago, mainly due to limited-pay products reaching paid-up status. Net investment income, net of amortized hedge costs*, decreased 1.4% to ¥67.1 billion. Total revenues in yen declined 1.6% to ¥413.9 billion. Pretax adjusted earnings in yen for the quarter declined 8.8% on a reported basis and 7.2% on a currency-neutral basis. The pretax adjusted profit margin for the Japan segment was 19.8%, compared with 21.4% a year ago. This reflects a favorable benefit ratio in 2018 and elevated expenses driven by reinvestment in the business in 2019.

For the full year, net premium income in yen was ¥1.4 trillion, or 1.1% lower than a year ago. Net investment income, net of amortized hedge costs, increased 2.2% to ¥271.3 billion. Total revenues in yen were down 0.6% to ¥1.7 trillion. Pretax adjusted earnings were ¥354.8 billion, or 0.2% higher than a year ago.

In dollar terms, net premium income increased 2.1% to $3.2 billion in the fourth quarter. Net investment income, net of amortized hedge costs, increased 2.7% to $618 million. Total revenues increased by 2.2% to $3.8 billion. Pretax adjusted earnings declined 5.1% to $757 million.

For the full year, net premium income in dollars was $12.8 billion, or 0.1% higher than a year ago. Net investment income, net of amortized hedge costs, increased 3.9% to $2.5 billion. Total revenues were up 0.7% to $15.3 billion. Pretax adjusted earnings were $3.3 billion, or 1.7% higher than a year ago.

For the quarter, new annualized premium sales (sales) for protection-type first sector and third sector products decreased 23.6% to ¥18.1 billion, and total sales decreased 23.4% to ¥18.5 billion, or $170 million.

For the full year, sales for protection-type first sector and third sector products decreased 16.8% to ¥78.2 billion, and total sales decreased 16.9% to ¥79.7 billion, or $731 million.

AFLAC U.S.

Aflac U.S. net premium income rose 1.1% to $1.4 billion in the fourth quarter. Net investment income decreased 1.6% to $180 million. Total revenues were up 1.6% to $1.6 billion. Pretax adjusted earnings were $275 million, 0.4% higher than a year ago, despite higher anticipated expenses in the quarter. The pretax adjusted profit margin for the U.S. segment was 16.8%, compared with 17.0% a year ago.

For the full year, net premium income rose 1.8% to $5.8 billion. Net investment income decreased slightly by 1.0% to $720 million. Total revenues were up 1.7% to $6.6 billion. Pretax adjusted earnings were $1.3 billion, 1.0% lower than a year ago.

Aflac U.S. sales decreased 0.7% in the quarter to $534 million. For the full year, total new sales decreased 1.3% to $1.6 billion.

CORPORATE AND OTHER

For the quarter, total revenue increased 14.0% to $106 million, reflecting net investment income of $50 million and lower corporate expenses. Net investment income, which increased $12 million, benefited from a $27 million pretax contribution from the company’s enterprise corporate hedging program. Pretax adjusted earnings were a loss of $9 million, compared with a loss of $26 million a year ago.

For the full year, total revenue increased 15.9% to $393 million, reflecting net investment income of $177 million. Net investment income, which increased $64 million, benefited from a $89 million pretax contribution from the company’s enterprise corporate hedging program. Pretax adjusted earnings were a loss of $72 million, compared with a loss of $139 million a year ago.

DIVIDEND

The board of directors declared the first quarter dividend of $0.28 per share, payable on March 2, 2020 to shareholders of record at the close of business on February 19, 2020.

OUTLOOK

Commenting on the company’s results, Chairman and Chief Executive Officer Daniel P. Amos stated: "We are pleased with the company’s overall performance for the year. Total pretax adjusted earnings increased 2.5%, which is particularly impressive considering our extensive investments to drive future earned premium growth, which will remain a critical strategic focus for 2020. I am pleased with the Board’s decision to increase the dividend, coming off our 37th consecutive year of dividend increases and a recognition of the stability of our earnings and capital generation. It also demonstrates our commitment to rewarding our shareholders.

"As expected, Aflac Japan saw a decline in total earned premium in 2019 mainly due to limited-pay policies reaching paid-up status, which has minimal effect on profitability. Additionally, as we anticipated, full-year third sector and first sector protection sales were down in the mid-teens, primarily reflecting reduced sales of our cancer insurance through Japan Post and following a strong 2018 with the launch of our revised cancer insurance product. Earned premium growth for third and first sector protection products was 1.3%, which was in line with our expectation. As communicated on our 2020 outlook call, we expect a decline in the range of 0.7% in third sector and first sector protection earned premium for the year.

"With respect to our U.S. operations, our financial results for the year were consistent with our expectations and reflected elevated expenses as a result of ongoing investments in our platform, distribution and customer experience. While sales were down slightly for the year, earned premium grew 1.8%. In line with what we communicated on the 2020 outlook call, we expect Aflac U.S. to generate earned premium growth in the range of 1% and maintain stable persistency. We will continue to invest in product development and efforts to facilitate producer growth and productivity, including the measured roll-out of Aflac Dental and Vision that was initiated in January.

"Turning to investments, net investment income closed out a strong year in the face of lower rates in the U.S. and Japan, while at the same time positioning the credit quality of the portfolio to perform well should there be economic weakness. Consistent with Aflac Global Investments’ business strategy, we closed on the acquisition of a non-controlling minority interest in Varagon Capital Partners in January 2020, where we are also making a multi-year commitment to build a portfolio of middle market loans. A natural extension of our external manager program, we expect this strategy to deliver incremental value in future years.

"We remain committed to maintaining strong capital ratios on behalf of our policyholders and maintaining a strong risk-based capital ratio in the U.S. and solvency margin ratio in Japan. We will also continue to reinvest in our business, recognizing that prudent investment in our platform is also critical to our growth strategy and driving efficiencies that ultimately will impact the bottom line. We balance reinvestment with a focus on increasing the dividend and repurchasing shares. We expect share repurchase will be in the range of $1.3 to $1.7 billion in 2020, with the range allowing us to be more tactical in our deployment strategy. As always, this assumes stable capital conditions and the absence of compelling alternatives.

"As we look to 2020, our objective is to produce stable adjusted earnings per diluted share of $4.32 to $4.52, assuming the 2019 weighted-average exchange rate of 109.07 yen to the dollar. As always, we are working very hard to achieve our earnings-per-share objective while also ensuring we deliver on our promise to policyholders."

*See Non-U.S. GAAP Financial Measures section for an explanation of foreign exchange and its impact on the financial statements and definitions of the non-U.S. GAAP financial measures used in this earnings release, as well as a reconciliation of such non-U.S. GAAP financial measures to the most comparable U.S. GAAP financial measures.

Emtora Biosciences Presents Phase Ib Data in Low Grade Prostate Cancer Patients at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium

On February 4, 2020 Emtora Biosciences, a privately-held, clinical stage life science company developing eRapaTM for the prevention of cancer progression reported a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Clinical Immuno-Oncology Symposium to be held in Orlando, FL, February 6-8 (Press release, Emtora Biosciences, FEB 4, 2020, View Source [SID1234553848]). Emtora’s core technology incorporates submicron rapamycin particles into a pH-sensitive polymer, improving bioavailability and allowing for consistent and lower dosing than generic rapamycin. Emtora was awarded a grant from the Cancer Prevention and Research Institute of Texas (CPRIT) in 2019 to continue the advancement of eRapa in a Phase 2a trial, which is scheduled to begin in April 2020.

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"We are pleased to share data from our first-in-human trial of eRapa at the ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium this year," commented George Peoples, MD, Chief Medical Officer of Emtora Biosciences. "The trial results are an important validation of eRapa’s potential to positively impact the immune system at low and/or intermittent doses and provide valuable safety, tolerability, and dosing information for the company’s upcoming Phase 2a efficacy study."

The poster features results of the company’s Phase 1b trial of eRapa in 14 low grade prostate cancer (PCa) patients. eRapa capitalizes on the potential of partial and/or intermittent inhibition of the mechanistic target of rapamycin (mTOR) to act as a cancer immuno-oncology and chemopreventative agent. In patients with low-grade PCa, treatment with low dose eRapa was found to be safe and well-tolerated. The dose of 0.5mg daily produced predictable, low, and stable blood concentration levels through the duration of treatment and resulted in a positive immune impact by enhancing CD8+ memory T cells. Further investigation with low dose and/or intermittent dosing of eRapa as a preventive agent in PCa and other indications will be required to establish clinical benefit. The poster is currently available on the conference website.

Poster Presentation Details
Title: Results of a Phase 1b Trial of Encapsulated Rapamycin in Prostate Cancer Patients Under Active Surveillance to Prevent Progression
Presenting Author: Phillip Kemp Bohan, MD
Session Information: Poster Session A
Abstract Number: 34
Date: February 6, 2020, 11:30AM-1:00PM and 6:00PM-7:00PM

Boundless Bio Announces Presentations at Upcoming February Conferences

On February 4, 2020 Boundless Bio, a company interrogating and targeting extrachromosomal DNA (ecDNA) in aggressive cancers, reported presentations at the following upcoming conferences this month (Press release, Boundless Bio, FEB 4, 2020, View Source [SID1234553847]):

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5th Annual Biomarker and Companion Diagnostics Conference: Jason Christiansen, Ph.D., Chief Technology Officer of Boundless Bio, will give a presentation titled: "Targeting extrachromosomal DNA (ecDNA), a new approach to treating cancers with high copy number gene amplification." The presentation will take place at 3:25 p.m. PST on Friday, February 7, 2020 in San Diego, California.

BIO CEO & Investor Conference: Zachary Hornby, President and Chief Executive Officer of Boundless Bio, will provide an overview of the company’s efforts to pioneer novel cancer therapeutics directed to ecDNA. The presentation will take place at 1:30 p.m. EST on Monday, February 10, 2020 in New York, New York.
About ecDNA

Extrachromosomal DNA, or ecDNA, are large circles of DNA containing genes that are outside the cells’ chromosomes and can make many copies of themselves. ecDNA can be rapidly replicated within the cell, causing high numbers of oncogene copies, a trait that can be passed to daughter cells in asymmetric ways during cell division. Cells have the ability to upregulate or downregulate ecDNA and resulting oncogenes to ensure survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment evasion. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

SIRION Biotech Licenses Adenovirus Technology to Danish Startup, InProTher for its Novel Immunotherapy Design Targeting Endogenous Retrovirus (ERV)

On February 4, 2020 SIRION Biotech GmbH ("SIRION"), a world leader in viral vector-based gene delivery technologies for gene and cell therapy, and InProTher Aps ("InProTher"), a Danish start up supported by Novo Nordisk Foundation’s BioInnovation Institute (BII), reported a broad licensing agreement which includes coverage of SIRION’s adenovirus technologies to cancer vaccines encoding Endogenous Retrovirus (ERV)-derived antigens for active immunotherapy (Press release, Sirion Therapeutics, FEB 4, 2020, View Source [SID1234553846]). In addition, the companies have agreed to the assignment of ownership rights in a patent application for an adenoviral vector capable of encoding a virus-like particle (VLP), which displays an inactive immune-suppressive domain (ISD). This vaccine shows an improved immune response from either or both of the response pathways initiated by CD4 T cells or CD8 T cells. SIRION and InProTher have been collaborating for over five years in the fields of HPV vaccine development and ERVs.

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InProTher is an immunotherapy company that is applying adenovirus technologies both for cloning large nucleic acids and increasing the yield of replication-incompetent adenoviruses. The goal is to develop the world’s first adaptive immune therapy capable of targeting immunosuppressive genes of ancient retroviruses that normally are dormant in the human genome. The retroviral genes are reactivated in cancer and essential for tumor development. InProTher’s proprietary combination of novel technologies is designed to break tolerance to this unique antigen family, thus providing broad anti-cancer efficacy.

As part of this agreement, SIRION Biotech will receive shares of InProTher Aps, as well as representation on their Board of Directors. The parties have also agreed on milestones and royalties should InProTher’s developments pass clinical development hurdles.

"This innovative cancer vaccine approach holds great promise, and our adenovirus was initially developed for such a vaccination. We congratulate InProTher as they prepare to enter clinical development with the support of the BII," said Dr. Christian Thirion, Chief Executive Officer of SIRION.

Peter J. Holst, Ph.D., Interim CEO and CSO of InProTher, is a former Associate Professor at the University of Copenhagen with long-standing experience in immunology, having made pivotal discoveries in the field. "InProTher’s proprietary combination of novel technologies is designed to break tolerance to this unique antigen family, thus providing broad anti-cancer efficacy. SIRION has been a creative, loyal and responsive partner over the years, and their adenovirus technology is ideally suited to our needs."