First Mesothelioma Patient Dosed in CA-170 Study

On January 24, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the first mesothelioma patient has been enrolled and dosed in the Phase I study of CA-170 (Press release, Curis, JAN 24, 2019, View Source [SID1234532882]). CA-170 is an orally available, dual inhibitor of VISTA and PDL1, which the company believes could provide benefit in tumors with high levels of VISTA expression. Over 90% of mesothelioma cells express VISTA.

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The company had previously announced its expectation to begin enrollment of mesothelioma patients in a dedicated cohort within the existing Phase 1 study.

"We are pleased to announce that the CA-170 study has begun dosing patients ahead of schedule," said James Dentzer, President & CEO of Curis. "On last quarter’s earnings call, we outlined the reorganization of company resources to strengthen focus on clinical execution. Today’s announcement is a result of those efforts. We re-iterate our confidence in our expectation to report initial efficacy data in this study in the second half of 2019."

CA-170 is the only anti-VISTA therapeutic currently being studied in a clinical trial. CA-170 has demonstrated favorable safety and tolerability, as well as preliminary anti-tumor activity in patients across multiple tumor types. The Phase I study is the first clinical trial of CA-170 to specifically target a patient population characterized by high levels of VISTA expression.

About the Study
The Phase I, open-label, dose escalation and dose expansion trial evaluating the safety, pharmacokinetics, pharmacodynamics, and clinical effects of orally administered CA-170 in patients with advanced tumors and lymphomas. The dedicated mesothelioma cohort will evaluate CA-170 at two dose levels.

About VISTA
VISTA (V-domain Ig-containing Suppressor of T cell Activation) is an independent, inhibitory T cell checkpoint protein that is expressed on both immune cells and tumor cells. VISTA has been identified as a potential resistance mechanism to treatment with anti-PD1 antibodies in melanoma and anti-CTLA4 antibodies in prostate cancer. Recent literature indicates that high levels of VISTA expression have been found on various tumors, including mesothelioma, ovarian cancer, endometrial cancer, triple negative breast cancer, gastric cancer, and non-small cell lung cancer.

Abbott Reports 2018 Results and Issues Strong Forecast for 2019

On January 23, 2019 Abbott reported financial results for the fourth quarter and full year ended Dec. 31, 2018, and issued financial outlook for 2019 (Press release, Abbott, JAN 23, 2019, View Source [SID1234532828]) (Press release, Abbott, JAN 23, 2019, View Source [SID1234532828]).

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· Full-year 2018 worldwide sales of $30.6 billion increased 11.6 percent on a reported basis and 7.3 percent on an organic* basis.

· Reported diluted EPS from continuing operations under GAAP was $1.31 in the full year 2018 and adjusted diluted EPS from continuing operations, which excludes specified items, was $2.88, reflecting 15.2 percent growth1.

· Fourth-quarter worldwide sales of $7.8 billion increased 2.3 percent on a reported basis and 6.4 percent on an organic basis.

·Reported diluted EPS from continuing operations under GAAP was $0.37 in the fourth quarter and adjusted diluted EPS from continuing operations, which excludes specified items, was $0.81.

·Abbott issues full-year 2019 guidance for organic sales growth of 6.5 to 7.5 percent2, which excludes the impact of foreign exchange, and diluted EPS from continuing operations on a GAAP basis of $1.80 to $1.90. Projected full-year adjusted diluted EPS from continuing operations is $3.15 to $3.25, reflecting double-digit growth at the mid-point.

· In 2018, Abbott generated strong operating cash flow and paid down more than $8 billion of debt.

·During 2018, Abbott returned $2 billion to shareholders in the form of dividends and, in December, announced a 14.3 percent increase in its quarterly common dividend.

·In October, Abbott received U.S. FDA approval of its HeartMate 3TM left ventricular assist device as a destination (long-term use) therapy. In January 2019, Abbott announced U.S. FDA approval of its TactiCathTM Contact Force Ablation Catheter, Sensor EnabledTM, a new catheter designed to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.

"2018 was another outstanding year for Abbott," said Miles D. White, chairman and chief executive officer, Abbott. "We exceeded the organic sales growth range we set at the beginning of the year, achieved a number of significant advances in our pipeline, and significantly improved our balance sheet and strategic flexibility. We’re very well-positioned heading into 2019."

FOURTH-QUARTER AND FULL-YEAR 2018 BUSINESS OVERVIEW

Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

For 2018, Organic sales growth:

· Excludes prior year results for the Abbott Medical Optics (AMO) and St. Jude Medical vascular closure businesses, which were divested during the first quarter 2017;

· Excludes the current and prior year results for Rapid Diagnostics, which reflect results for Alere Inc., which was acquired on Oct. 3, 2017;

· Excludes the prior year fourth quarter results for a non-core business within U.S. Adult Nutrition, which was discontinued during the third quarter 2018; and

· Excludes the impact of foreign exchange.

Total YTD 2018 Abbott sales from continuing operations include Other Sales of $62 million.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Fourth-quarter 2018 worldwide sales of $7.8 billion increased 2.3 percent on a reported basis. On an organic basis, worldwide sales increased 6.4 percent. For the full-year 2018, worldwide sales increased 11.6 percent on a reported basis and 7.3 percent on an organic basis. Refer to pages 16 and 17 for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales decreased 0.4 percent on a reported basis in the fourth quarter. On an organic basis, sales increased 3.6 percent. For the full-year 2018, worldwide sales increased 4.4 percent on a reported basis and 5.2 percent on an organic basis. Refer to pages 16 and 17 for a reconciliation of adjusted historical revenue.

Worldwide Pediatric Nutrition sales increased 1.2 percent on a reported basis in the fourth quarter, including an unfavorable 2.5 percent effect of foreign exchange, and increased 3.7 percent on an organic basis. International pediatric sales decreased 0.8 percent on a reported basis, including an unfavorable 4.5 percent effect of foreign exchange, and increased 3.7 percent on an organic basis. Performance in the quarter was led by above-market growth in the U.S. and strong growth across several markets in Asia and Latin America, including China, Vietnam and Mexico.

Worldwide Adult Nutrition sales decreased 2.5 percent on a reported basis in the fourth quarter, and increased 3.5 percent on an organic basis. International adult sales increased 0.9 percent on a reported basis, including an unfavorable 5.7 percent effect of foreign exchange, and increased 6.6 percent on an organic basis. Worldwide sales performance was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

n/a = Percent change is not applicable as organic results exclude Rapid Diagnostics in 2018.

Rapid Diagnostics reflects sales from Alere Inc., which was acquired on Oct. 3, 2017. Organic growth rates above exclude results from the Rapid Diagnostics business.

n/m = Percent change is not meaningful.

Worldwide Diagnostics sales increased 2.9 percent on a reported basis in the fourth quarter. On an organic basis, sales increased 7.4 percent. For the full-year 2018, worldwide sales increased 33.5 percent on a reported basis and 6.7 percent on an organic basis. Refer to pages 16 and 17 for a reconciliation of adjusted historical revenue.

Core Laboratory Diagnostics sales increased 5.0 percent on a reported basis in the fourth quarter, including an unfavorable 4.4 percent effect of foreign exchange, and increased 9.4 percent on an organic basis, reflecting above-market growth in the U.S. and internationally, where Abbott is seeing continued strong adoption of Alinity TM, Abbott’s family of innovative and highly differentiated diagnostic instruments.

Molecular Diagnostics sales increased 1.4 percent on a reported basis in the fourth quarter, including an unfavorable 2.4 percent effect of foreign exchange, and increased 3.8 percent on an organic basis. Worldwide sales were led by growth in infectious disease testing, Abbott’s core area of focus in the molecular diagnostics market.

Point of Care Diagnostics sales decreased 5.5 percent on a reported basis in the fourth quarter, including an unfavorable 0.4 percent effect of foreign exchange, and decreased 5.1 percent on an organic basis.

Rapid Diagnostics worldwide sales of $548 million were led by infectious disease and cardiometabolic testing.

Established Pharmaceuticals sales decreased 4.8 percent on a reported basis in the fourth quarter, including an unfavorable 8.4 percent effect of foreign exchange, and increased 3.6 percent on an organic basis. As expected, sales growth in the fourth quarter was negatively impacted by a comparison versus the fourth-quarter of 2017, when organic sales grew 14.0 percent.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 6.2 percent on a reported basis in the fourth quarter, including an unfavorable 10.5 percent effect of foreign exchange, and increased 4.3 percent on an organic basis. For the full-year 2018, sales in key emerging markets increased 1.7 percent on a reported basis and 7.4 percent on an organic basis led by double-digit growth in India and China.

Other sales increased 0.2 percent on a reported basis in the fourth quarter and 1.3 percent on an organic basis. For the full-year 2018, Other sales increased 8.1 percent on a reported basis and 5.8 percent on an organic basis.

Worldwide Medical Devices sales increased 6.7 percent on a reported basis in the fourth quarter. On an organic basis, sales increased 9.0 percent. For the full-year 2018, worldwide sales increased 10.1 percent on a reported basis and 9.1 percent on an organic basis. Refer to page 17 for a reconciliation of adjusted historical revenue.

In Electrophysiology, growth was led by strong performance in cardiac mapping and ablation catheters. In January 2019, Abbott announced U.S. FDA approval of its TactiCath Contact Force Ablation Catheter, Sensor Enabled, a new catheter designed to help physicians accurately and effectively treat atrial fibrillation.

Growth in Structural Heart was driven by several product areas across Abbott’s broad portfolio, including AMPLATZERTM PFO Occluder, a device designed to close a hole-like opening in the heart, and MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation, a leaky heart valve.

In Diabetes Care, sales increased 28.3 percent on a reported basis and 32.4 percent on an organic basis in the fourth quarter, led by rapid market uptake of FreeStyle Libre, Abbott’s revolutionary sensor-based continuous glucose monitoring system, which removes the need for routine fingersticks3 for people with diabetes.

ABBOTT ISSUES GUIDANCE FOR 2019

Abbott is issuing full-year 2019 guidance for organic sales growth of 6.5 to 7.5 percent2, which excludes the impact of foreign exchange, and diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $1.80 to $1.90. Abbott forecasts net specified items for the full year 2019 of $1.35 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $3.15 to $3.25 for the full year 2019.

Abbott is issuing first-quarter 2019 guidance for diluted earnings per share from continuing operations under GAAP of $0.25 to $0.27. Abbott forecasts specified items for the first quarter 2019 of $0.35 per share primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.60 to $0.62 for the first quarter.

ABBOTT ANNOUNCES INCREASE IN QUARTERLY DIVIDEND

Dec. 14, 2018, the board of directors of Abbott increased the company’s quarterly dividend to $0.32 per share from $0.28 per share, an increase of 14.3 percent. Abbott’s cash dividend is payable Feb. 15, 2019, to shareholders of record at the close of business on Jan. 15, 2019. This marks the 380th consecutive quarterly dividend to be paid by Abbott.

Abbott has increased its dividend payout for 47 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

bridgebio pharma closes $299.2 million financing round to support its efforts to target genetic disease at the source

On January 23, 2019 BridgeBio Pharma, a clinical-stage biopharmaceutical company focused on genetic diseases, reported a new financing round of $299.2 million (Press release, BridgeBio, JAN 23, 2019, View Source [SID1234576267]). The round was co-led by existing investors KKR and Viking Global Investors. Other existing investors participating included Perceptive Advisors, AIG, Aisling Capital, Cormorant Capital, and Hercules Capital; and they were joined by new investors Sequoia Capital, and a blue-chip long-term investor. The financing will be used to support BridgeBio Pharma’s existing drug research and development programs and expand its efforts to rapidly develop medicines for patients with unmet needs.

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"We are privileged to be working with investors who believe in our goal of creating medicines for patients with genetic disease. We are aware that many of these patients lack effective treatment options, and we take our mission to help them seriously," said Neil Kumar, Ph.D, co-founder and chief executive officer of BridgeBio Pharma. "The path from promising early-stage science to a drug that makes a difference for patients requires a long-term vision and steady commitment. We are fortunate to have our investors’ support as we develop these treatments."

Genetic diseases are conditions that derive directly from mutations in their patients’ DNA. These mutations can be either inherited or spontaneous, and the diseases stemming from them include both Mendelian diseases, which tend to affect pediatric patients, and cancers. While there are more than 7,000 genetic diseases affecting 25 to 30 million Americans in aggregate, fewer than 500 drugs are approved for these conditions, leaving a significant number of patients without any therapeutic options.

BridgeBio Pharma was formed in 2015 by a team of drug research and development veterans from both the biotech industry and academia. The company seeks to translate novel scientific discoveries from universities, academic medical centers, and pharmaceutical research groups into genetically-targeted therapeutics that address the fundamental causes of disease. Its portfolio of more than 15 assets includes several in the pre-clinical stages of development, as well as four programs in or approaching pivotal trials.

Each of these drug assets is housed in its own subsidiary company, with access to centralized resources and capabilities courtesy of a novel corporate structure developed in conjunction with Dr. Andrew Lo of MIT’s Sloan School of Management. BridgeBio employs a lean, capital-efficient model that harnesses a central research and development platform to simultaneously operate multiple programs that fit the company’s stringent science criteria. Using this model, personnel and funding can be efficiently redistributed amongst the assets on an as-needed basis. The portfolio assets span therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. Some of the specific indications targeted include transthyretin amyloidosis (ATTR-CM and ATTR-PN), pantothenate kinase-associated neurodegeneration (PKAN), Gorlin syndrome and frequent basal cell carcinomas, dystrophic epidermolysis bullosa (DEB), Darier and Hailey-Hailey diseases, Netherton syndrome, venous malformations, Canavan disease, Leber’s hereditary optic neuropathy, molybdenum cofactor deficiency Type A, achondroplasia, and FGFR, SHP-2, and K-RAS-driven cancers.

Sierra Oncology to Present at the DNA Damage Response Therapeutics Summit

On January 23, 2019 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported that its Chief Scientific Officer, Dr. Christian Hassig, will present "Addressing Intrinsic & Acquired PARP Inhibitor (PARPi) Resistance Through Chk1 Inhibition" at the DNA Damage Response (DDR) Therapeutics Summit in Boston, MA (Press release, Sierra Oncology, JAN 23, 2019, View Source [SID1234532829]). The presentation is scheduled for 9:00 am Eastern Time (ET) on January 30, 2019.

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"Targeting components of the DDR machinery that regulate replication stress, such as Chk1, represents an attractive therapeutic strategy to address both intrinsic and acquired PARPi resistance," noted Dr. Hassig. "For example, CCNE1-driven tumors, frequently found in high grade serous ovarian, breast and endometrial cancers, are associated with high replication stress and are generally insensitive to PARPi therapy. We have demonstrated that our Chk1 inhibitor, SRA737, plus low dose gemcitabine is highly effective in CCNE1-amplified preclinical models, where low-dose gemcitabine induces an additional exogenous form of replication stress further enhancing sensitivity to Chk1 inhibition. Moreover, PARPi acquired resistance is driven, in part, through increased replication fork stabilization and partial recovery of homologous recombination repair, two processes regulated by Chk1. As such, our preclinical results suggest that combining PARPi with SRA737 may prove effective in treating this significant emerging clinical issue."

Sierra Oncology is a key sponsor of the DNA Damage Response Therapeutics Summit, which will gather leading stakeholders from across drug development over two days to discuss how to advance the therapeutic potential of targeting DNA repair pathways.

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Sierra also announced that on January 21, 2019 the Compensation Committee of Sierra Oncology’s Board of Directors granted non-qualified stock options to purchase an aggregate of 141,000 shares of its common stock to 5 new employees under Sierra Oncology’s 2018 Equity Inducement Plan.

The 2018 Equity Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sierra (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Sierra, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The options have an exercise price of $1.41 per share, which is equal to the closing price of Sierra’s common stock on January 22, 2018, the first day on which markets are open following the date of grant. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient’s start date, and then will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee’s continued employment with Sierra on such vesting dates. The options are subject to the terms and conditions of Sierra’s 2018 Equity Inducement Plan, and the terms and conditions of the stock option agreement covering the grant.

Cellectar Biosciences, Inc. January 2019 Corporate Presentation

On January 23, 2019 Cellectar Biosciences, Inc. presented the Corporate Presentation (Presentation, Cellectar Biosciences, JAN 23, 2019, View Source [SID1234532939]).

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