On January 24, 2018 Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) (Cyclacel or the Company), a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases, reported that the Company will present at the 14th Annual Noble Capital Markets Investor Conference being held January 29 & 30, 2018 in Boca Raton, FL (Press release, Cyclacel, JAN 24, 2018, View Source [SID1234523544]). Spiro Rombotis, President & Chief Executive Officer will provide an overview of the Company and progress in key programs.

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Information on the presentation is as follows:

Event: 14th Annual Noble Capital Markets Investor Conference
Date: Tuesday, January 30, 2018
Time: 3:00 pm ET
Location: W Hotel, Studio 3, Fort Lauderdale, FL

A live webcast of the presentation will be available through the Company’s website: www.cyclacel.com. The webcast will be archived for 90 days.

On January 24, 2018 Abbott (NYSE: ABT) reported financial results for the fourth quarter ended Dec. 31, 2017 (Press release, Abbott, JAN 24, 2018, View Source [SID1234523542]).

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Fourth-quarter worldwide sales of $7.6 billion increased 42.3 percent on a reported basis and 7.7 percent on a comparable operational* basis.

Reported diluted EPS from continuing operations under GAAP was a $(0.50) loss in the fourth quarter, primarily due to the net expense of $1.46 billion for the estimated1 impact of the Tax Cuts and Jobs Act (U.S. tax reform). Excluding the impact of U.S. tax reform and other specified items, adjusted diluted EPS from continuing operations was $0.74 in the fourth quarter, at the high end of the previous guidance range of $0.72 to $0.74.
Abbott issues full-year 2018 guidance for diluted EPS from continuing operations on a GAAP basis of $1.22 to $1.32. Projected full-year adjusted diluted EPS from continuing operations is $2.80 to $2.90, reflecting 14.0 percent growth2 at the midpoint.

In October, Abbott received U.S. FDA clearance for its Confirm Rx Insertable Cardiac Monitor (ICM), the world’s first and only smartphone-compatible ICM designed to help physicians remotely identify cardiac arrhythmias, and obtained CE Mark for XIENCE Sierra, the newest generation of the company’s gold-standard XIENCE everolimus-eluting coronary stent system.

In November, Abbott initiated the U.S. launch of FreeStyle Libre, the only continuous glucose monitoring (CGM) system available that comes factory-calibrated and removes the need for routine fingersticks3 for people with diabetes. In January, Abbott announced that FreeStyle Libre is now available and approved for coverage by the U.S. Center for Medicare & Medicaid Services (CMS).

In December, Abbott received U.S. FDA approval for magnetic resonance (MR)-conditional labeling for its Quadra Assura and Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D) devices and its Fortify Assura implantable cardioverter defibrillator (ICD). With these approvals, Abbott has MR-conditional labeling for its full suite of pacemaker, ICD and CRT-D devices.

"2017 was a great year for us – we performed well, our new product pipeline was highly productive and we took some very important strategic steps forward," said Miles D. White, chairman and chief executive officer, Abbott. "We’re entering 2018 with very good momentum."

FOURTH-QUARTER BUSINESS OVERVIEW

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

Comparable operational sales growth:

Includes prior year results for St. Jude Medical, which was acquired on Jan. 4, 2017, and reflects a reduction to St. Jude Medical’s historic sales related to administrative fees paid to conform to Abbott’s presentation;
Excludes prior year and current 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 year results for Rapid Diagnostics, which reflect results for Alere, Inc., which was acquired on Oct. 3, 2017; and Excludes the impact of exchange.

* Total Abbott sales from continuing operations include Other Sales of $17 million. In 2016, the AMO business, which was divested during the first quarter 2017, was reported as part of the Medical Devices group. Comparable operational growth rates above exclude results from the AMO business.

* In 2017, total Abbott sales from continuing operations include Other Sales of $237 million, including sales of $175 million from the AMO business, which was divested during the first quarter 2017. In 2016, the AMO business was reported as part of the Medical Devices group. Comparable operational growth rates above exclude results from the AMO business.

n/a = Not Applicable.

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 2017 worldwide sales of $7.6 billion increased 42.3 percent on a reported basis. On a comparable operational basis, worldwide sales increased 7.7 percent. Refer to tables titled "Non-GAAP Reconciliation of Comparable Historical Revenue" for a reconciliation of comparable historical revenue.

Worldwide Nutrition sales increased 3.0 percent on a reported basis in the fourth quarter, including a favorable 1.0 percent effect of foreign exchange, and increased 2.0 percent on an operational basis.

Worldwide Pediatric Nutrition sales increased 2.4 percent on a reported basis in the fourth quarter, including a favorable 0.9 percent effect of foreign exchange, and increased 1.5 percent on an operational basis. In the U.S., continued above-market growth was led by Abbott’s market-leading toddler brands, PediaSure and Pedialyte. International sales decreased 0.2 percent on an operational basis, as growth in China and India was offset by continued challenging market conditions in certain other international countries.

Worldwide Adult Nutrition sales increased 3.6 percent on a reported basis in the fourth quarter, including a favorable 0.8 percent effect of foreign exchange, and increased 2.8 percent on an operational basis. Worldwide sales growth was led by 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. Comparable operational growth rates above exclude results from the Rapid Diagnostics business.

Worldwide Diagnostics sales increased 51.7 percent on a reported basis in the fourth quarter. On a comparable operational basis, sales increased 6.7 percent. Refer to tables titled "Non-GAAP Reconciliation of Comparable Historical Revenue" for a reconciliation of comparable historical revenue.

Core Laboratory Diagnostics sales increased 9.4 percent on a reported basis in the fourth quarter, including a favorable 2.2 percent effect of foreign exchange, and increased 7.2 percent on an operational basis, reflecting continued above-market growth driven by share gains globally.

Molecular Diagnostics sales increased 4.2 percent on a reported basis in the fourth quarter, including a favorable 1.8 percent effect of foreign exchange, and increased 2.4 percent on an operational basis. As expected, growth in infectious disease testing, Abbott’s core area of focus in the molecular diagnostics market, was partially offset by a planned scale down in other testing areas, primarily in the U.S.

Point of Care Diagnostics sales increased 7.2 percent on a reported basis in the fourth quarter, including a favorable 0.4 percent effect of foreign exchange, and increased 6.8 percent on an operational basis, led by continued adoption of Abbott’s i-STAT handheld system.

Rapid Diagnostics sales of $540 million were led by infectious disease testing, including flu and strep testing.

Established Pharmaceuticals sales increased 17.0 percent on a reported basis in the fourth quarter, including a favorable 3.0 percent effect of foreign exchange, and increased 14.0 percent on an operational basis.

Key Emerging Markets comprise several countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 15.0 percent on a reported basis in the fourth quarter, including a favorable 2.5 percent effect of foreign exchange, and increased 12.5 percent on an operational basis. Operational sales growth was led by double-digit growth across several geographies, including India, China and Latin America.

Other sales increased 19.6 percent on an operational basis primarily due to the favorable timing of sales in certain countries during the fourth quarter.

Worldwide Medical Devices sales increased 102.2 percent on a reported basis in the fourth quarter. On a comparable operational basis, sales increased 9.6 percent. Refer to tables titled "Non-GAAP Reconciliation of Comparable Historical Revenue" for a reconciliation of comparable historical revenue.

In Cardiovascular and Neuromodulation, worldwide sales in the fourth quarter were led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Neuromodulation. In Electrophysiology, during the fourth quarter, Abbott initiated the U.S. launch of its Confirm Rx Insertable Cardiac Monitor (ICM), the world’s first and only smartphone-compatible ICM designed to help physicians remotely identify cardiac arrhythmias. Growth in Structural Heart was driven by MitraClip, Abbott’s market-leading device for the minimally-invasive treatment of mitral regurgitation. In Heart Failure, sales growth was led by market uptake of Abbott’s HeartMate 3 system, which received U.S. FDA approval in the third quarter of 2017. In Neuromodulation, strong double-digit growth was led by several recently launched products for the treatment of chronic pain and movement disorders.

In the fourth quarter, in Rhythm Management, Abbott received U.S. FDA approval for MR-conditional labeling for its Quadra Assura and Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D) devices and its Fortify Assura implantable cardioverter defibrillator (ICD). In Vascular, Abbott obtained CE Mark for its XIENCE Sierra drug-eluting coronary stent system, which enhances its competitive position in this category of the market.

In Diabetes Care, worldwide sales increased 33.2 percent on a reported basis in the fourth quarter, including a favorable 5.6 percent effect of foreign exchange, and increased 27.6 percent on an operational basis. Strong double-digit international sales growth was led by FreeStyle Libre, Abbott’s revolutionary CGM system. FreeStyle Libre is the only CGM system available that comes factory-calibrated and removes the need for routine fingersticks3 for people with diabetes. During the fourth quarter, Abbott initiated the U.S. launch of FreeStyle Libre, and in January 2018, Abbott announced that FreeStyle Libre is now available and approved for coverage by CMS.

ABBOTT ISSUES FINANCIAL OUTLOOK FOR 2018

Abbott is issuing full-year 2018 guidance for diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $1.22 to $1.32.

Abbott forecasts net specified items for the full year 2018 of approximately $1.58 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 $2.80 to $2.90 for the full year 2018.

Abbott is issuing first-quarter 2018 guidance for diluted earnings per share from continuing operations under GAAP of $0.16 to $0.18. Abbott forecasts specified items for the first quarter of $0.41 per share primarily related to intangible amortization expense, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.57 to $0.59.

Abbott has stated its commitment to reduce its debt levels following the recent acquisitions of St. Jude Medical and Alere, Inc. For the full year 2017, Abbott generated operating cash flow in excess of $5.0 billion and free cash flow4 in excess of $4.0 billion. In January 2018, Abbott repaid $4.0 billion of debt and anticipates additional debt repayments throughout 2018.

ABBOTT ANNOUNCES INCREASE IN QUARTERLY DIVIDEND

On Dec. 15, 2017, the board of directors of Abbott increased the company’s quarterly dividend to $0.280 per share from $0.265 per share. Abbott’s cash dividend is payable Feb. 15, 2018, to shareholders of record at the close of business on Jan. 12, 2018. This marks the 376th consecutive quarterly dividend to be paid by Abbott.

Abbott has increased its dividend payout for 46 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.

On January 23, 2018 Skyhawk Therapeutics, Inc. ("Skyhawk"), a new private company focused on the discovery and development of small molecule therapeutics that correct RNA expression, reported the close of $8 million in seed funding led by major family and biotech investors, including Tim Disney, the Duke of Bedford, Alexandria Venture Investments, and other undisclosed private investors (Press release, Skyhawk Therapeutics, JAN 23, 2018, https://www.prnewswire.com/news-releases/skyhawk-therapeutics-launches-with-8-million-in-seed-financing-to-advance-its-novel-platform-and-portfolio-of-small-molecules-that-correct-rna-expression-300586378.html [SID1234551690]). Proceeds of the financing will advance Skyhawk’s portfolio of specific and selective small molecules that initially target RNA exon skipping, which drives a set of 50+ diseases that include both broad-based neurological conditions and previously "undruggable" oncogenes in cancer.

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"We are pleased be working with leading investors to advance our mission of revolutionizing disease treatment with small molecules that correct RNA expression," said founding investor and executive chairman of Skyhawk’s board of directors, Bill Haney. "The Skyhawk team has spent the last 12 months building an expansive intellectual property base covering its unique drug discovery tools and small molecule library portfolio. The company’s first drug candidate targets a set of exon-skipping-driven cancer indications, and we are focusing our energy on driving it into the clinic in 2019."

Initially, Skyhawk is targeting diseases driven by a type of RNA mis-splicing called "exon skipping," where key regions on the RNA are left out during the RNA splicing process. Skyhawk’s proprietary technology enables the rational design of small molecules that target specific binding pocket regions on RNA, using both sequence and structural specificity, at particular moments in the RNA splicing process. By doing so, they reverse the mis-splicing and treat the disease.

"The ability to use small molecule therapeutics to selectively target RNA and correct RNA expression is potentially transformative," said Catherine Nuccio of Alexandria Venture Investments. "The technology has now moved beyond proof of concept and is applicable in a range of diseases for the benefit of a broad base of patients. We are excited to seed and support the team that helped to develop the initial technology and its mechanisms."

There are 50+ known diseases driven by exon skipping, from broad based neurological conditions to major cancers, and hundreds more driven by similar forms of RNA mis-expression.

Skyhawk Founders and Board of Directors
Skyhawk founders and founding board of directors include:

William Haney, Skyhawk co-founder and executive chairman of the Skyhawk board of directors, and co-founder and CEO of Dragonfly Therapeutics. Bill is currently CEO of Dragonfly Therapeutics, a Boston-based biotech that develops novel first-in-class therapeutics targeted at natural killer (NK) cells and other cells of the innate immune system. He is an investor and entrepreneur, having started or helped start more than a dozen technology companies.
Kathleen McCarthy, Skyhawk co-founder and CEO. Kathleen is a leading expert in developing small molecules to target RNA splicing. As a pre-clinical scientist at the Spinal Muscular Atrophy (SMA) Foundation in New York and at Roche in Basel, Switzerland, Kathleen helped bring the first-ever small molecule therapeutic targeting mRNA-protein interactions to clinical trials in SMA. She is a co-inventor and co-author on numerous patents and publications describing small molecules that specifically and selectively target RNA expression.
Kevin Koch, Skyhawk founding board member, venture partner with OrbiMed Advisors, LLC and President and CEO of Edgewise Therapeutics. Dr. Koch was formerly SVP of Drug Discovery: Chemical and Molecular Therapeutics at Biogen, where he managed global drug discovery and immunology. He was the co-founder of Array BioPharma, where he oversaw the invention of over 20 clinical development candidates, and has held senior positions at Amgen Inc. and Pfizer Central Research.
Andrew Boyd, Skyhawk founding board member and Fidelity Head of Global Equity Capital Markets. Andrew is head of Global Equity Capital Markets at Fidelity Management & Research Company, where he leads the private equity investments across the Fidelity funds. In this role he has been at the forefront of technology development, and has been a leading investor in firms such as Uber, Snapchat and SpaceX.
Andrew Bedford, Skyhawk founding board member, technology investor and Duke of Bedford, England. Andrew currently manages a broad portfolio of London properties, and, as the 15th Duke of Bedford, England, serves as a British nobleman and peer. He is an investor and board member in numerous companies with 30+ years’ experience in international real estate and technology.
Skyhawk Founding Scientific Advisory Board
Skyhawk’s founding scientific advisory board (SAB) is comprised of scientists with expertise in RNA-based disease and neurological conditions, mechanisms of RNA splicing, alternative splicing regulation in cancer, DNA replication and RNA structural biology. Members include:

Friedrich Metzger, founding chairman of the Skyhawk scientific advisory board and former Head of Discovery Rare Diseases at Roche. Dr. Metzger is a leading scientist in RNA-based disease and neurological conditions. At Roche, Dr. Metzger spent 15 years running drug discovery programs for Alzheimer’s, ALS, Parkinson’s, Duchenne Muscular Dystrophy and Spinal Muscular Atrophy (SMA). He is the senior author on the Science and Nature papers describing the first small molecules that could specifically and selectively target RNA expression.
Jacqueline A. Lees, founding member of the Skyhawk scientific advisory board, Associate Director of the Koch Institute for Integrative Cancer Research, and Professor of Biology at MIT. Dr. Lees is a leading scientist in cancer cell cycle regulation and alternative splicing regulation in cancer. Her research focuses on metastasis and personalized medicine, and the genetic causes of cancer.
Adrian Krainer, founding member of the Skyhawk scientific advisory board, member of the American Academy of Arts & Sciences, and Professor at Cold Spring Harbor Laboratory. Dr. Krainer is a world expert on the role of mRNA splicing proteins in cancer, and neurological and rare diseases. His lab is leading the understanding of mechanisms of RNA splicing, and the means by which faulty splicing can be corrected.
Steven Bell, founding member of the Skyhawk scientific advisory board, Investigator at Howard Hughes Medical Institute, member of the National Academy of Sciences, and Professor of Biology at MIT. Dr. Bell is a leading scientist in the study of DNA replication, with an emphasis on how assembly of enzymes is regulated during the cell cycle to ensure genomic maintenance.
Frédéric Allain, founding member of the Skyhawk scientific advisory board and Professor/Head of the Institute of Molecular Biology and Biophysics at ETH, Zurich, Switzerland. Dr. Allain is a leading scientist in the role of RNA in disease and the use of NMR technology to elucidate the structure of protein RNA complexes. He and his team are expert in the use of biophysical tools to study protein RNA interactions and mRNA splicing regulation, with a focus on the segment of genetic diseases that originate from post-transcriptional misregulation of gene expression often caused by splicing, RNA editing or translation defects.
"Skyhawk’s founding team has unique depth of experience in this growing area of small molecule therapeutic development." said Tim Disney, founding investor in Skyhawk. "To support their mission we put together a long-term, science-focused group of investors, who share their humility in the face of this great opportunity, and a strong interest on getting drugs to patients, quickly."

On January 23, 2018 GT Biopharma Inc. (OTCQB: GTBP and Euronext Paris: GTBP.PA) reported that it has entered into definitive agreements for a private placement of convertible notes and warrants for gross proceeds of $7,055,000 (Press release, GT Biopharma , JAN 23, 2018, View Source [SID1234539535]). The company intends to use the proceeds from the financing to advance its immuno-oncology programs, which are based on the company’s proprietary Tri and Tetra-specific Natural Killer Cell Engagers (TriKEs and TetraKEs) and bispecific antibody-drug conjugate (ADC) platforms, neurology (CNS) pipeline progress, and for general corporate purposes.

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Oppenheimer & Co. Inc. acted as the sole placement agent for the offering.

The convertible notes are unsecured, have a face amount of $7,760,508, a 0% coupon, an initial conversion price of $4.58, subject to adjustment, and are due July 2018. Investors also received warrants to purchase approximately 1,694,440 shares of GT Biopharma common stock at an initial exercise price of $4.58 per share, subject to adjustment.

Roth Capital Partners also acted as a financial advisor to GT Biopharma for this transaction.

On January 23, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 1,242 million in 2017. Net sales were USD 884 million in the U.S. and net sales in the rest of the world were USD 358 million (Press release, Genmab, JAN 23, 2018, View Source [SID1234523485]). Genmab receives royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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DARZALEX was approved in the U.S. in November 2015, in Europe in May 2016 and in Japan in September 2017. Worldwide net sales of DARZALEX in 2016 were USD 572 million, resulting in royalty income of DKK 458 million to Genmab.