UPDATE ON SALE OF LOMIKO TECHNOLOGIES INC. AND PROMETHIEUS LISTING

Promethieus Confirms EU Listing

Vancouver, B.C., Dec. 13, 2019 (GLOBE NEWSWIRE) — Lomiko Metals Inc. (“Lomiko”) (TSX-V: LMR, OTC: LMRMF, FSE: DH8C) Lomiko Metals Inc. announced July 31, 2019 that it had entered into an agreement to sell it’s 100% interest in Lomiko Technologies Inc. to Promethieus Technologies Inc. (Canada) for $ 1,236,625 and will be reimbursed $ 193,614.32 in expenses paid by Lomiko Metals on behalf of Promethieus Technologies Inc.

On November 25, 2019 Lomiko Metals Inc. provided shareholders with an update to the transaction and on December 3, 2019, confirmed that shareholders had overwhelmingly approved the transaction at the November 29, 2019 Annual Special General Meeting.

The transaction was subject to (1) shareholder approval; (2) Promethieus completing a financing; and (3) regulatory approval.  The transaction was considered a non-arms length transaction as Mr. A. Paul Gill is a Director of all the entities involved.

In regards to item 2 above, Promethieus has advised Lomiko that it is in the process of an application for listing on a European Union recognized stock exchange. The process of listing includes a rigorous examination of the listing application and has taken longer than expected.  In recognition of this progress, both Lomiko and Promethieus have agreed to extend the deadline for the completion of the transaction to June 30, 2020 to allow the transaction to complete. 

For more information on Lomiko Metals, SHD Smart Home Devices or Promethieus, review the website at www.lomiko.com, www.shddevices.com and www.promethieus.com, or email: info@lomiko.com.

On Behalf of the Board

“Julius Galik”

Julius Galik,

Director

We seek safe harbor.

 

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Attachment

A. Paul Gill
Lomiko Metals Inc. (TSX-V: LMR)
6047295312
apaulgill@lomiko.com

Weatherford Successfully Completes Financial Restructuring

Emerges from Chapter 11 and Appoints New Board of Directors

PR Newswire

HOUSTON, Dec. 13, 2019 /PRNewswire/ — Weatherford International plc today announced that it has completed its financial restructuring and emerged from chapter 11 protection.

The Company emerges with a stronger financial foundation having reduced approximately $6.2 billion of outstanding funded debt, secured $2.6 billion in exit financing facilities, including a $450 million revolving credit facility, secured a $195 million letter of credit facility, and secured over $900 million of liquidity.

“This is a notable day for Weatherford as we have emerged as a stronger, more focused organization,” said Mark A. McCollum, President and Chief Executive Officer of Weatherford. “With renewed balance sheet strength, a strong customer base and a portfolio designed to meet the needs of our industry, we believe we are well-positioned to build on our reputation as a leader in the oilfield services sector and to capitalize on the growth opportunities ahead. I want to thank our dedicated employees, customers and suppliers, who continued to believe in Weatherford and worked with us to achieve this successful balance sheet recapitalization.”

Weatherford expects its newly issued ordinary shares will initially resume trading on the OTC Markets with the Company ultimately planning to transition trading to the New York Stock Exchange, subject to the receipt of applicable approvals. The transition to the New York Stock Exchange is expected to occur after the Company reports results for its fourth quarter ending December 31, 2019, holds an investor call, and completes the fresh-start accounting process, which are expected to be completed by early March (details to follow).

New Board of Directors
A new Board of Directors was appointed upon the Company’s emergence, providing critical expertise and experience to Weatherford as it enters the next phase of growth and innovation. The new Board of Directors consists of seven members, including Chairman of the Board Thomas R. Bates, Jr., John F. Glick, Neal P. Goldman, Gordon T. Hall, Mark A. McCollum, Jacqueline Mutschler, and Charles M. Sledge.  Regarding the new Board, Mr. McCollum continued: “The knowledge and engagement of our new Board of Directors will better enable us to deliver on the opportunities in front of us and remain focused on achieving objectives that are in the best interest of all the Company’s stakeholders.”

Weatherford was represented in the recapitalization by Latham & Watkins LLP, Matheson, Hunton Andrews Kurth LLP, Lazard Freres & Co. LLC, Alvarez & Marsal and Conyers Dill & Pearman.

Forward-Looking Statements
Certain statements in this press release are forward-looking statements. In addition, our management may from time to time make oral forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. Forward-looking statements may be identified by the words “believe,” “expect,” “anticipate,” “project,” “plan,” “estimate,” “may,” “will,” “could,” “should,” “seek” or “intend” and similar expressions. Forward-looking statements reflect our current expectations and assumptions regarding our business, the economy and other future events and conditions and are based on currently available financial, economic and competitive data and our current business plans. Actual results could vary materially depending on risks and uncertainties that may affect our operations, markets, services, prices and other factors as discussed in the Risk Factors section of our filings with the Securities and Exchange Commission (the “SEC”). While we believe our assumptions are reasonable, we caution you against relying on any forward-looking statements as it is very difficult to predict the impact of known factors, and it is impossible for us to anticipate all factors that could affect our actual results. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, management’s expectations of plans, strategies, objectives, growth and anticipated financial and operational performance; financial prospects; anticipated sources and uses of capital and other matters that are not historical facts. For a more detailed discussion of these and other risk factors, see the Risk Factors section in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q and our other filings made with the SEC. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. The forward-looking statements made by us speak only as of the date on which they are made. Factors or events that could cause our actual results to differ may emerge from time to time. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.

About Weatherford

Weatherford is one of the largest multinational oilfield service companies providing innovative solutions, technology and services to the oil and gas industry. The Company operates in more than 80 countries and has a network of 620 locations, including manufacturing, service, research and development, and training facilities and employs more than 24,000 people. For more information, visit www.weatherford.com and connect with Weatherford on LinkedIn, Facebook, Twitter and YouTube.

Contacts:       

Stuart Fraser

+1.713.836.4208
Interim Chief Financial Officer           

Karen David-Green 
+1.713.836.7430
Senior Vice President Stakeholder Engagement and Chief Marketing Officer

Weatherford logo. (PRNewsFoto/WEATHERFORD INTERNATIONAL)

 

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SOURCE Weatherford International plc

Amarin Receives FDA Approval of VASCEPA® (icosapent ethyl) to Reduce Cardiovascular Risk

VASCEPA becomes the first and only FDA-approved medication for reducing cardiovascular risk beyond cholesterol lowering therapy in high-risk patients approved for treatment

– Millions of people in the United States qualify as treatment candidates For VASCEPA

– Cardiovascular disease events, including heart attack, stroke and cardiovascular death, occur in the United States every 14 seconds and are economically, physically and emotionally costly

– VASCEPA has been assessed by independent bodies as priced cost effectively as a cardiovascular risk reduction treatment

– VASCEPA total net revenue guidance increased for 2019 to a range of $410 to $425 million and for 2020 is newly guided to a projected range of $650 to $700 million

Amarin to host webcast on Monday, December 16 at 7:30 a.m., Eastern Time

PR Newswire

DUBLIN and BRIDGEWATER, N.J., Dec. 13, 2019 /PRNewswire/ — Amarin Corporation plc (NASDAQ: AMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication and label expansion for VASCEPA® (icosapent ethyl) capsules. After more than a decade of development and testing, VASCEPA is now the first and only drug approved by the FDA “as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.” It is estimated that millions of high-risk patients in the United States could benefit from this one-of-a-kind prescription therapy.1

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8653351-amarin-vascepa-fda-approval-cardiovascular-risk/

“We at Amarin are excited and gratified to now have the opportunity to introduce VASCEPA as a new FDA-approved treatment option to reduce the persistent cardiovascular risk that many patients face despite use of statins with other contemporary standard-of-care therapies,” said John F. Thero, president and chief executive officer of Amarin. “We aim to help millions of high-risk patients, including statin-treated patients and statin-intolerant patients. For the first time, physicians, patients and payers have an FDA-approved treatment option beyond cholesterol lowering that has been demonstrated to significantly reduce major adverse cardiovascular events when used on top of a statin. We look forward to helping educate physicians and patients on the value of VASCEPA. The expanded indication and related clinical study labeling is broadly worded, informative on the many effects of VASCEPA and will empower physicians with critical information to help them apply their clinical judgment in addressing cardiovascular disease risk for patients in need.”

Amarin reaffirmed its intention to promptly launch VASCEPA in the United States for this important new preventative care indication. As previously disclosed, Amarin doubled the size of its sales force near the beginning of 2019 and is on track to double the size of its sales force again to a total of 800 sales representatives near the beginning of 2020.

“The FDA approval of icosapent ethyl as an addition to statin therapy to reduce the risk of cardiovascular events is a major milestone in cardiovascular prevention,” said Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School, and lead investigator of the REDUCE-IT study which served as the basis for the supplemental New Drug Application to the FDA for VASCEPA. “Nothing this significant has happened in the world of cardiovascular prevention since the introduction of statins nearly three decades ago. Many patients stand to benefit from this historic advance in care.”

In the global REDUCE-IT®cardiovascular outcomes study, approximately 28 percent of patients in the control arm treated with statins and other contemporary therapy but not treated with VASCEPA experienced a major adverse cardiovascular event (MACE), defined as the first occurrence of either myocardial infarction (heart attack), stroke, coronary revascularization, unstable angina requiring hospitalization or cardiovascular death.2 As evidenced by this MACE occurrence, there is a group of patients who, despite controlling their cholesterol on statin therapy, continue to have a high need for additional preventative cardiovascular care. For those adult patients in this group who have elevated triglycerides (TG) ≥150 mg/dL and established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease, VASCEPA is the first drug approved to help reduce this persistent cardiovascular risk. In a published exploratory analysis of the REDUCE-IT study, examining total (first and subsequent) cardiovascular events over a period of approximately five years, patients taking VASCEPA on average experienced one fewer MACE per six patients studied, representing a 30 percent risk reduction in total MACE compared to placebo.3

The overall rates of adverse events and serious adverse events in the 5-year REDUCE-IT study were similar between VASCEPAtreated patients and placebo-treated patients. As reflected in VASCEPA’s expanded label and described below, VASCEPA has been associated with increased risks of bleeding and atrial fibrillation/flutter, the latter being more prevalent in patients with a previous history of atrial fibrillation or flutter. It is recommended that patients taking VASCEPA and concomitant anticoagulants and/or anti-platelet agents for bleeding be monitored. Also noted in the REDUCE-IT study is that patients for whom bleeding and/or atrial fibrillation/flutter were reported appeared to obtain a similar reduction in MACE as patients not reporting such adverse events. Such findings are consistent with published results of the study, which noted that the increased rates of such adverse events were low, notably lower than the reduction in MACE.3  

Recurrent event analyses were conducted of the total primary endpoint events and total key secondary endpoints in REDUCE-IT using a series of statistical models and published in the Journal of the American College of Cardiology. These analyses are not in FDA labeling, were tertiary or exploratory endpoints; most of the models used were prespecified and one was post hoc. Each recurrent event statistical model has inherent strengths and weaknesses, with no single model considered definitive or outperforming the other models, and this is an evolving field of science. Nonetheless, results from these analyses are consistent across the various models; they also are consistent with the original primary and secondary endpoint results. Together, the REDUCE-IT recurrent event analyses and the original primary and key secondary endpoint analyses support the robustness of the clinical benefit of VASCEPA therapy in reducing cardiovascular risk.

Need Is Acute for a Cost-Effective, Preventative-Care Therapy Like VASCEPA
Despite current treatment options, in the United States, there is one stroke and one heart attack each occurring on average every 40 seconds, and one cardiovascular death occurring on average every 38 seconds, or, in aggregate one such cardiovascular event every 14 seconds.4,5 Cardiovascular disease costs in the United States are in excess of $500 billion each year, making it the nation’s most expensive disease.6 The number of cardiovascular deaths is also increasing, serving as the No. 1 cause of death for men and women in the United States.7 These facts point to an acute need for more innovation in the cardiovascular disease therapeutic area.

Since statin therapy was introduced nearly three decades ago, healthcare professionals have sought effective preventative care treatment options to reduce persistent cardiovascular risk beyond management of cholesterol. Many potential solutions failed to show favorable effects in cardiovascular outcomes studies. The development of VASCEPA included learnings from these failures and now VASCEPA is the first and only drug to succeed in reducing that risk in the patient group included in the new VASCEPA label.    

Recently, a health economics study conducted by an expert group presented at the American Heart Association 2019 Scientific Sessions showed that use of VASCEPA offers potential cost savings for the overall healthcare system (i.e., the cost of VASCEPA is offset by cost savings from reducing the occurrence of high-cost major adverse cardiovascular events).7 This rare finding follows conclusions from a separate independent drug pricing watchdog group that found VASCEPA cost effective for cardiovascular risk reduction, a result seldom achieved in this organization’s analyses.

Based on the unprecedented results of the REDUCE-IT outcomes study, multiple professional societies have updated guidelines or issued advisories to incorporate icosapent ethyl, including the American Diabetes Association,9 the European Society of Cardiology, The European Atherosclerosis Association,10 and the National Lipid Association.11

Today’s announced new indication for VASCEPA is incremental to its indication for which it was initially FDA approved, as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

“In achieving this expanded indication, Amarin appreciates the FDA’s guidance in the design and conduct of multiple clinical trials of VASCEPA across the past decade and for its diligence in reviewing the results of these studies,” said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. “Moreover, Amarin is grateful to the thousands of patients and clinical sites who participated in the extensive study of VASCEPA, which exceeded 37,000 patient-years of study in the clinical development program. Amarin also thanks its dedicated employees and advisors who overcame many challenges to achieve this important life-saving accomplishment.”

Revenue Guidance Updated for 2019 and Provided for 2020 
Amarin last updated its revenue guidance for 2019 in its press release dated July 2, 2019.  Amarin now makes the following update to that guidance and issues its first guidance for 2020:

With respect to the year ending December 31, 2019, while the year is not yet complete, Amarin increases its guidance for total net revenue to a range of $410 to $425 million. Prior guidance for this period given in July 2019 was total net revenue in a range of $380 to $420 million. The midpoint of this new full-year 2019 guidance, $417.5 million, would represent an increase of approximately 82% over full year 2018 results.

With respect to 2020, Amarin projects that total net revenue will be in a range of $650 to $700 million, mostly from sales of VASCEPA in the United States. Amarin is providing this projected revenue guidance for 2020 and has based its projection on a number of factors, including, but not limited to, expectations on market acceptance of the newly expanded label for VASCEPA and current plans for expanded promotion. VASCEPA revenues are anticipated to continue to increase in 2020, accompanied by quarterly industry variability, including recurring seasonal factors, particularly in the first quarter. Given that it takes time to educate providers and patients, Amarin expects a delayed impact from planned promotional programs either because they are new, such as the impact of new sales representatives, or, in the case of direct-to-consumer promotion, because separate regulatory approval is required and not currently expected until  mid-2020. In addition, while multiple studies have concluded that VASCEPA is cost effective, how managed care organizations will react to a cost-effective therapy lacks adequate precedent.

Beyond 2020, Amarin believes that VASCEPA total net revenue will grow to reach multiple billions of dollars. However, the history of other therapies for chronic conditions suggests that growth builds over multiple years. At this time, the company is not providing guidance regarding annual revenue levels beyond 2020.

Conference Call and Webcast Information:
Amarin will host a conference call Monday, December 16, at 7:30 a.m. ET to discuss this information. The conference call can be heard live on the investor relations section of the company’s website at www.amarincorp.com, or via telephone by dialing 877-407-8033 within the United States, 201-689-8033 from outside the United States, or by using the call back feature at https://bit.ly/35nxY8k. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call, dial 877-481-4010, PIN: 56897. A replay of the call will also be available through the company’s website shortly after the call.

About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over eight million times and is covered by most major medical insurance plans. The new, cardiovascular risk indication for VASCEPA was approved by the FDA in December 2019.

Indications and Limitation of Use

VASCEPA is indicated:

  • As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
    • established cardiovascular disease or
    • diabetes mellitus and two or more additional risk factors for cardiovascular disease.
  • As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information

  • VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
  • VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
  • It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur. 
  • VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
  • Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
  • Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
  • Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
  • Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents for bleeding should be monitored.

Key clinical effects of VASCEPA on major adverse cardiovascular events are included in the Clinical Studies section of the prescribing information for VASCEPA, as set forth below:

Effect of VASCEPA on Time to First Occurrence of Cardiovascular Events in Patients with Elevated Triglyceride Levels and Other Risk Factors for Cardiovascular Disease in REDUCE-IT


VASCEPA


Placebo


VASCEPA

vs Placebo


N = 4089


n (%)


Incidence
Rate

(per 100
patient
years)


N = 4090



n (%)


Incidence
Rate

(per 100
patient
years)


Hazard Ratio
(95% CI)


Primary composite endpoint

Cardiovascular death, myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina (5-point MACE)

705

(17.2)

4.3

901

(22.0)

5.7

0.75

(0.68, 0.83)


Key secondary composite endpoint

Cardiovascular death, myocardial infarction, stroke (3-point MACE)

459

(11.2)

2.7

606

(14.8)

3.7

0.74

(0.65, 0.83)


Other secondary endpoints

Fatal or non-fatal myocardial infarction

250

(6.1)

1.5

355

(8.7)

2.1

0.69

(0.58, 0.81)

Emergent or urgent coronary revascularization

216

(5.3)

1.3

321

(7.8)

1.9

0.65

(0.55, 0.78)

Cardiovascular death 1

174

(4.3)

1.0

213

(5.2)

1.2

0.80

(0.66, 0.98)

Hospitalization for unstable angina 2

108

(2.6)

0.6

157

(3.8)

0.9

0.68

(0.53, 0.87)

Fatal or non-fatal stroke

98

(2.4)

0.6

134

(3.3)

0.8

0.72

(0.55, 0.93)

[1] Includes adjudicated cardiovascular deaths and deaths of undetermined causality.

[2] Determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

About Amarin
Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Amarin’s lead product, VASCEPA® (icosapent ethyl), is available by prescription in the United States, Lebanon and the United Arab Emirates. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in Canada, China, the European Union and the Middle East. For more information about Amarin, visit www.amarincorp.com.

Forward-Looking Statements
This press release contains forward-looking statements, including expectations regarding commercial expansion and the use of VASCEPA to potentially help millions of patients, revenue and prescription growth, including updated revenue guidance for 2019 and guidance for 2020 and beyond; sales force expansion and marketing initiatives expected in 2019 and beyond; managed care acceptance; the applicability and reliability of REDUCE-IT results and cost effectiveness data. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In addition, Amarin’s ability to effectively commercialize VASCEPA will depend in part on its ability to continue to effectively finance its business, efforts of third parties, its ability to gain regulatory approvals, create market demand for VASCEPA through education, marketing and sales activities, to achieve market acceptance of VASCEPA, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of VASCEPA and to maintain patent protection for VASCEPA. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with acceptance of clinical trial results and related regulatory approvals; the risk that sales may not meet expectations and related cost may increase beyond expectations; the risk that patents may not be upheld in patent litigation and applications may not result in issued patents sufficient to protect the VASCEPA franchise. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Availability of Other Information About Amarin
Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.


Amarin Contact Information



Investor Inquiries:


Elisabeth Schwartz

Investor Relations
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com

Lee M. Stern

Solebury Trout
In U.S.: +1 (646) 378-2992
lstern@soleburytrout.com


Media Inquiries:


Gwen Fisher

Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 325-0735
pr@amarincorp.com

References

1 Fan W, Philip S, Toth PP, et al. Prevalence of United States adults with triglycerides ≥ 135 mg/dL: NHANES 2007–2014. Cardiol J. 2019;26(5). DOI: 10.5603/CJ.2019.0000.
2 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380:11-22.
3 Bhatt DL, Steg PG, Miller M, et al. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol 2019; 73:2791-2802.
4 American Heart Association: Heart Disease and Stroke Statistics — 2019 At-a-Glance.
5 American Heart Association. Heart Disease and Stroke Statistics – 2019 Update: A Report from the American Heart Association. Published January 31, 2019.
6 American Heart Association. 2017. Cardiovascular disease: A costly burden for America projections through 2035.
7 Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT. https://www.abstractsonline.com/pp8/#!/7891/presentation/35097.
https://icer-review.org/wp-content/uploads/2019/02/ICER_CVD_Final_Evidence_Report_10.17.19.pdf.
9 American Diabetes Association. [web annotation]. Diabetes Care 2019;42(Suppl.1):S103–S123.
10 Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2019; ehz455. doi: 10.1093/eurheartj/ehz455.
11 Orringer CE, Jacobson TA, Maki KC. National Lipid Association scientific statement on the use of icosapent ethyl in statin-treated patients with elevated triglycerides and high- or very-high ASCVD risk. J Clin Lipidol. 2019. doi: 10.1016/j.jacl.2019.10.014.

 

 

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SOURCE Amarin Corporation plc

Live Nation Entertainment, Zebra Technologies, STERIS Set to Join S&P 500; Others to Join S&P MidCap 400 and S&P SmallCap 600

PR Newswire

NEW YORK, Dec. 13, 2019 /PRNewswire/ — S&P Dow Jones Indices will make the following index adjustments to the S&P 500, S&P MidCap 400 and S&P SmallCap 600 to ensure each index more appropriately represents its market capitalization range. The changes will be effective prior to the open of trading on Monday, December 23 to coincide with the December rebalance.

S&P MidCap 400 constituents Live Nation Entertainment Inc. (NYSE:LYV), Zebra Technologies Corp. (NASD:ZBRA), and STERIS plc (NYSE:STE) will move to the S&P 500, switching places with Affiliated Managers Group Inc. (NYSE:AMG), TripAdvisor Inc. (NASD:TRIP), and The Macerich Co. (NYSE:MAC) respectively. All companies moving to the S&P 500 have market capitalizations above $12 billion, and all companies moving to the S&P MidCap 400 have market capitalizations below $4.5 billion.

Grand Canyon Education Inc. (NASD:LOPE), and Lear Corp. (NYSE:LEA) will replace Oasis Petroleum Inc. (NYSE:OAS) and Southwestern Energy Co. (NYSE:SWN) in the S&P MidCap 400 respectively. Oasis Petroleum and Southwestern Energy will replace Unit Corp. (NYSE:UNT) and Frontier Communications Corp. (NASD:FTR) in the S&P SmallCap 600. Oasis Petroleum and Southwestern Energy are more representative of the small-cap market space, while Unit and Frontier Communications are no longer representative of the small-cap market space.

S&P SmallCap 600 constituent Arrowhead Pharmaceuticals Inc. (NASD:ARWR) will switch places with Granite Construction Inc. (NYSE:GVA) in the S&P MidCap 400. Arrowhead Pharmaceuticals has a market capitalization more representative of the mid-cap market space, and Granite Construction has a market capitalization more representative of the small-cap market space.

Live Nation Entertainment operates as a live entertainment company. Headquartered in Beverly Hills, CA, the company will be added to the S&P 500 GICS (Global Industry Classification Standard) Movies & Entertainment Sub-Industry index.

Zebra Technologies designs, manufactures, and sells a range of automatic identification and data capture products. Headquartered in Lincolnshire, IL, the company will be added to the S&P 500 GICS Electronic Equipment & Instruments Sub-Industry index.

STERIS provides infection prevention and other procedural products and services. Headquartered in Dublin, Ireland, the company will be added to the S&P 500 GICS Health Care Equipment Sub-Industry index.

Affiliated Managers Group operates as an asset management company. Headquartered in West Palm Beach, FL, the company will be added to the S&P MidCap 400 GICS Asset Management & Custody Banks Sub-Industry index.

TripAdvisor operates as an online travel company. Headquartered in Needham, MA, the company will be added to the S&P MidCap 400 GICS Interactive Media and Services Sub-Industry index.

The Macerich Company, a real estate investment trust (REIT), focuses on the acquisition, leasing, management, development and redevelopment of regional malls. Headquartered in Santa Monica, CA, the company will be added to the S&P MidCap 400 GICS Retail REITs Sub-Industry index.

Grand Canyon Education provides education services.  Headquartered in Phoenix, AZ, the company will be added to the S&P MidCap 400 GICS Education Services Sub-Industry index.

Lear designs, develops, engineers, manufactures, assembles, and supplies automotive seating, and electrical distribution systems and related components for automotive original equipment manufacturers. Headquartered in Southfield, MI, the company will be added to the S&P MidCap 400 GICS Auto Parts & Equipment Sub-Industry index.

Oasis Petroleum focuses on the acquisition and development of onshore unconventional oil and natural gas resources. Headquartered in Houston, TX, the company will be added to the S&P SmallCap 600 GICS Oil and Gas Exploration and Production Sub-Industry index.

Southwestern Energy engages in the exploration, development, and production of natural gas and oil. Headquartered in Spring, TX, the company will be added to the S&P SmallCap 600 GICS Oil and Gas Exploration and Production Sub-Industry index.

Arrowhead Pharmaceuticals develops medicines for the treatment of intractable diseases. Headquartered in Pasadena, CA, the company will be added to the S&P MidCap 400 GICS Biotechnology Sub-Industry index.

Granite Construction operates as an infrastructure contractor and a construction materials producer. Headquartered in Watsonville, CA, the company will be added to the S&P SmallCap 600 GICS Construction & Engineering Sub-Industry index.

Following is a summary of the changes:


S&P 500 INDEX – December 23, 2019

COMPANY

GICS ECONOMIC SECTOR

GICS SUB-INDUSTRY

ADDED

Live Nation
Entertainment

Communication Services

Movies & Entertainment

Zebra
Technologies

Information Technologies

Electronic Equipment &
Instruments

STERIS

Health Care

Health Care Equipment

DELETED

Affiliated
Managers Group

Financials

Asset Management &
Custody Banks

TripAdvisor

Communication Services

Interactive Media &
Services

Macerich

Real Estate

Retail REITs

 


S&P MIDCAP 400 INDEX – December 23, 2019

COMPANY

GICS ECONOMIC SECTOR

GICS SUB-INDUSTRY

ADDED

Affiliated
Managers Group

Financials

Asset Management &
Custody Banks

TripAdvisor

Communication Services

Interactive Media &
Services

Macerich

Real Estate

Retail REITs

Grand Canyon
Education

Consumer Discretionary

Education Services

Lear

Consumer Discretionary

Auto Parts & Equipment

Arrowhead
Pharmaceuticals

Health Care

Biotechnology

DELETED

Live Nation
Entertainment

Communication Services

Movies & Entertainment

Zebra
Technologies

Information Technologies

Electronic Equipment &
Instruments

STERIS

Health Care

Health Care Equipment

Oasis Petroleum

Energy

Oil & Gas Exploration &
Production

Southwestern
Energy

Energy

Oil & Gas Exploration &
Production

Granite
Construction

Industrials

Construction &
Engineering

 


S&P SMALLCAP 600 INDEX – December 23, 2019

COMPANY

GICS ECONOMIC SECTOR

GICS SUB-INDUSTRY

ADDED

Oasis Petroleum

Energy

Oil & Gas Exploration &
Production

Southwestern
Energy

Energy

Oil & Gas Exploration &
Production

Granite
Construction

Industrials

Construction &
Engineering

DELETED

Unit

Energy

Integrated Oil & Gas

Frontier
Communications

Communication Services

Integrated

Telecommunication
Services

Arrowhead
Pharmaceuticals

Health Care

Biotechnology

 

For more information about S&P Dow Jones Indices, please visit www.spdji.com

ABOUT S&P DOW JONES INDICES
S&P Dow Jones Indices is the largest global resource for essential index-based concepts, data and research, and home to iconic financial market indicators, such as the S&P 500® and the Dow Jones Industrial Average®. More assets are invested in products based on our indices than products based on indices from any other provider in the world. Since Charles Dow invented the first index in 1884, S&P DJI has become home to over 1,000,000 indices across the spectrum of asset classes that have helped define the way investors measure and trade the markets.

S&P Dow Jones Indices is a division of S&P Global (NYSE: SPGI), which provides essential intelligence for individuals, companies, and governments to make decisions with confidence. For more information, visit www.spdji.com.

FOR MORE INFORMATION:

S&P Dow Jones Indices

index_services@spglobal.com

Media Inquiries

spdji.comms@spglobal.com

Index Governance Inquiries

IGCC@spglobal.com

Cision View original content:http://www.prnewswire.com/news-releases/live-nation-entertainment-zebra-technologies-steris-set-to-join-sp-500-others-to-join-sp-midcap-400-and-sp-smallcap-600-300974859.html

SOURCE S&P Dow Jones Indices

Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2019 SABCS

Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2019 SABCS

LOS ANGELES–(BUSINESS WIRE)–
Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, will present updated interim results from a Phase II clinical trial of Puma’s drug neratinib at the 2019 San Antonio Breast Cancer Symposium (SABCS) that is currently taking place in San Antonio, Texas. The presentation entitled, “Effect of prophylaxis or neratinib dose escalation on neratinib-associated diarrhea and tolerability in patients with HER2-positive early-stage breast cancer: Phase II CONTROL trial,” will be displayed at a poster session on December 13 at 5:00 p.m. CST. A full copy of the poster is available on the Puma Biotechnology website.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191213005405/en/

CONTROL Trial Poster at SABCS 2019 (Graphic: Business Wire)

CONTROL Trial Poster at SABCS 2019 (Graphic: Business Wire)

Neratinib was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as NERLYNX® (neratinib) tablets.

The main adverse event seen to date in clinical trials of neratinib is diarrhea and, more specifically, grade 3 diarrhea. In the Phase III ExteNET trial of neratinib as extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with adjuvant Herceptin, prophylactic use of anti-diarrheal medications was not mandatory. In the trial, 95.4% of the patients experienced all grade diarrhea and 39.8% of the patients experienced grade 3 or higher diarrhea (there was one event of grade 4 diarrhea). The median cumulative duration of grade 3 diarrhea in the ExteNET trial was 5 days and 16.8% of patients who received neratinib in the ExteNET trial discontinued the drug due to diarrhea.

The CONTROL trial is an international, open-label, Phase II study investigating the use of antidiarrheal prophylaxis or dose escalation in the reduction of neratinib-associated diarrhea that has a primary endpoint of the incidence of grade 3 diarrhea.

In the CONTROL trial, patients with HER2-positive early stage breast cancer who had completed trastuzumab-based adjuvant therapy received neratinib daily for a period of one year. The trial initially tested high dose loperamide prophylaxis given for the first 2 cycles (56 days) of treatment (12 mg on days 1-14, 8 mg on days 15-56 and as needed thereafter). The CONTROL trial was then expanded to include four additional cohorts. One cohort received the combination of loperamide and budesonide, the second cohort received the combination of loperamide plus colestipol, the third cohort received colestipol plus loperamide as needed and the fourth cohort did not use any antidiarrheal drugs as mandatory prophylaxis but instead used a dose escalation during the first month of neratinib treatment. Budesonide is a locally acting corticosteroid that Puma believes targets the inflammation identified in a preclinical model of neratinib-induced diarrhea and colestipol is a bile acid sequestrant that Puma believes targets potential bile acid malabsorption that could result from such inflammation. The dose escalation involved treating with neratinib at 120 mg per day for the first week, 160 mg per week for the second week and 240 mg per week starting at week 3 and until the end of treatment.

The interim analysis of the CONTROL trial presented in the poster included a total of 137 patients who received neratinib plus loperamide prophylaxis, 64 patients who received neratinib plus loperamide prophylaxis for 2 cycles and budesonide for 1 cycle, 136 patients who received neratinib plus loperamide prophylaxis for 1 cycle and colestipol for 1 cycle, 104 patients who received colestipol for 1 cycle and loperamide as needed and 60 patients who received the dose escalation regimen of neratinib.

The results of the trial showed that the incidence of grade 3 diarrhea for the 137 patients who received the loperamide prophylaxis was 31% and that for the 137 patients in this cohort, 20% discontinued neratinib due to diarrhea. The median cumulative duration of grade 3 diarrhea was 3 days.

For the 64 patients who received the combination of loperamide plus budesonide, the results of the trial showed that the incidence of grade 3 diarrhea was 28% and that for the 64 patients in this cohort, 11% discontinued neratinib due to diarrhea. The median cumulative duration of grade 3 diarrhea was 2.5 days.

For the 136 patients who received the combination of loperamide plus colestipol, the results of the trial showed that the incidence of grade 3 diarrhea was 21% and that for the 136 patients in this cohort, 4% discontinued neratinib due to diarrhea. The median cumulative duration of grade 3 diarrhea was 3.5 days.

For the 104 patients who received colestipol and loperamide as needed, the results of the trial showed that the incidence of grade 3 diarrhea was 34% and that for the 104 patients in this cohort, 8% discontinued neratinib due to diarrhea. The median cumulative duration of grade 3 diarrhea was 3 days.

For the 60 patients who received no antidiarrheal drugs as mandatory prophylaxis and dose escalation of neratinib in the first month, the results of the trial showed that the incidence of grade 3 diarrhea was 15% and that for the 60 patients in this cohort, 3% discontinued neratinib due to diarrhea. The median cumulative duration of grade 3 diarrhea was 2 days.

Further information is provided in Table 1 below:

Table 1: Incidence of Treatment-Emergent Diarrhea

 

 

 

 

 

 

Neratinib dose

 

 

Budesonide +

 

Colestipol +

 

Colestipol +

 

escalation +

Loperamide

 

loperamide

 

loperamide

loperamide prn

 

loperamide prn

(n=137)

 

(n=64)

 

(n=136)

 

(n=104)

 

(n=60)

 

Treatment-emergent diarrhea incidence, n (%)

No diarrhea

28 (20)

 

9 (14)

 

23 (17)

 

5 (5)

 

2 (3)

Grade 1

33 (24)

 

16 (25)

 

38 (28)

 

33 (32)

 

24 (40)

Grade 2

34 (25)

 

21 (33)

 

47 (35)

 

31 (30)

 

25 (42)

Grade 3

42 (31)

 

18 (28)

 

28 (21)

 

35 (34)

 

9 (15)

Grade 4

0

 

0

 

0

 

0

 

0

 

 

 

 

 

 

 

 

 

Diarrhea leading to discontinuation

28 (20.4)

 

7 (10.9)

 

5 (3.7)

 

8 (7.7)

 

2 (3.3)

 

 

 

 

 

 

 

 

 

Hospitalization (due to diarrhea)

2 (1.5)

 

0

 

0

 

0

 

0

 

 

 

 

 

 

 

 

 

Discontinuation of study (any cause)

61 (44.5)

 

13 (20.3)

 

39 (28.7)

 

29 (27.9)

 

12 (20.0)

Note:

Each patient was counted only once in the highest grade category.

No Grade 4 events reported in the CONTROL study.

Carlos H. Barcenas, MD, MS, Associate Professor in the Department of Breast Medical Oncology of The University of Texas MD Anderson Cancer Center, said, “We are pleased to see the maturation of the data supporting observations of a reduction in incidence, severity and duration of neratinib-associated diarrhea with loperamide prophylaxis, loperamide plus budesonide prophylaxis or the loperamide plus colestipol prophylaxis. Along with the continued reduction in the incidence and severity of grade 3 diarrhea with neratinib, diarrhea appears to be early onset, acute, self-limiting and manageable. Not only does the addition of budesonide or colestipol to loperamide prophylaxis appear to greatly improve the tolerability of neratinib, the dose escalation regimen appears as another promising option since there is no mandatory prophylaxis.”

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are pleased to note that the dose-escalation cohort of our CONTROL trial continues to show a marked improvement in the incidence of grade 3 diarrhea and related discontinuation of therapy. We remain committed to improving the tolerability of neratinib in early stage breast cancer patients.”

About HER2-Positive Breast Cancer

Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

IMPORTANT SAFETY INFORMATION

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

  • Diarrhea: Aggressively manage diarrhea occurring despite recommended prophylaxis with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
  • Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
  • Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight decreased and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and www.NERLYNX.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

  • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. When patients require gastric acid reducing agents, use an H2-receptor antagonist or antacid. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists.
  • Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
  • Strong or moderate CYP3A4 inducers: Avoid concomitant use.
  • P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.

USE IN SPECIFIC POPULATIONS:

  • Lactation: Advise women not to breastfeed.

Please see Full Prescribing Information for additional safety information.

The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. NERLYNX was granted marketing authorization by the European Commission in August 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.

Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500

info@pumabiotechnology.com

ir@pumabiotechnology.com

David Schull or Maggie Beller, Russo Partners, +1-212-845-4200

david.schull@russopartnersllc.com

maggie.beller@russopartnersllc.com

KEYWORDS: California Texas United States North America

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

MEDIA:

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CONTROL Trial Poster at SABCS 2019 (Graphic: Business Wire)

EQUITY ALERT: Rosen Law Firm Announces Investigation of Securities Claims Against Live Nation Entertainment, Inc. – LYV

EQUITY ALERT: Rosen Law Firm Announces Investigation of Securities Claims Against Live Nation Entertainment, Inc. – LYV

NEW YORK–(BUSINESS WIRE)–
Rosen Law Firm, a global investor rights law firm, announces it is investigating potential securities claims on behalf of shareholders of Live Nation Entertainment, Inc. (NYSE: LYV) resulting from allegations that Live Nation may have issued materially misleading business information to the investing public.

On December 13, 2019, the Wall Street Journal reported that the U.S. Department of Justice (“DOJ”) was preparing to take legal action against Live Nation based on allegations that the company sought to “strong-arm” concert venues into using its market-dominant Ticketmaster subsidiary. Such efforts would violate the terms of a settlement agreement that Live Nation and Ticketmaster reached with the government in 2010 as a condition of their merger. Under that agreement, the DOJ allowed the companies to combine, but required them to abide by conditions meant to preserve competition in the music and ticketing industries.

As a result of this news, Live Nation’s share price fell $5.09 or 7.3% to close at 64.34 on December 13, 2019.

Rosen Law Firm is preparing a class action lawsuit to recover losses suffered by Live Nation investors. If you purchased shares of Live Nation please visit the firm’s website at http://www.rosenlegal.com/cases-register-1741.htmlto join the class action. You may also contact Phillip Kim of Rosen Law Firm toll free at 866-767-3653 or via email at pkim@rosenlegal.com or cases@rosenlegal.com.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm or on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm.

Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has secured hundreds of millions of dollars for investors.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Laurence Rosen, Esq.

Phillip Kim, Esq.

The Rosen Law Firm, P.A.

275 Madison Avenue, 40th Floor

New York, NY 10016

Tel: (212) 686-1060

Toll Free: (866) 767-3653

Fax: (212) 202-3827

lrosen@rosenlegal.com

pkim@rosenlegal.com

cases@rosenlegal.com

www.rosenlegal.com

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Legal Professional Services

MEDIA:

Anixa Biosciences to Host Conference Call to Discuss Plans for 2020

PR Newswire

SAN JOSE, Calif., Dec. 13, 2019 /PRNewswire/ — Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, today announced that it will hold a conference call on December 17, 2019 at 1:30 p.m. Pacific / 4:30 p.m. Eastern to discuss the progress made and the future plans for its CchekTM artificial intelligence based cancer diagnostic test and its CAR-T based ovarian cancer therapeutic and breast cancer vaccine programs. 

Anixa Biosciences, Inc. (PRNewsfoto/Anixa Biosciences, Inc.)

Conference Call Information:
Interested participants and investors may access the conference call by dialing:

  • (877) 876-9174
  • Conference ID: Anixa

An audio webcast will be accessible via the Investors section of the Anixa website at https://ir.anixa.com/events.  An archive of the webcast will remain available for 30 days after the call.

About Anixa Biosciences, Inc.
Anixa is a publicly-traded biotechnology company focused on harnessing the body’s immune system in the fight against cancer.  Anixa’s therapeutic portfolio includes a cancer vaccine technology focused on the immunization against α-Lactalbumin to prevent triple negative breast cancer (TNBC), as well as a cancer immunotherapy program which uses a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology.  The company’s diagnostic portfolio consists of Cchek™, a liquid biopsy technology for early detection of solid tumors based on the body’s immune response to the presence of a malignancy.  Anixa continually examines emerging technologies in complementary fields for further development and commercialization.  Additional information is available at www.anixa.com.


Forward-Looking Statements:
  Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are not statements of historical facts, but rather reflect Anixa’s current expectations concerning future events and results.  We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements.  Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements.  These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.  We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.  You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release. 

Anixa contact:
Mike Catelani
mcatelani@anixa.com 
408-708-9808

Tiberend Strategic Advisors, Inc.

Miriam Miller (Investors)
mmiller@tiberend.com 
212-375-2694

Johanna Bennett (Media)
jbennett@tiberend.com 
212-375-2686

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/anixa-biosciences-to-host-conference-call-to-discuss-plans-for-2020-300974834.html

SOURCE Anixa Biosciences, Inc.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Yunji Inc. – YJ

NEW YORK, Dec. 13, 2019 (GLOBE NEWSWIRE) — Pomerantz LLP is investigating claims on behalf of investors of Yunji Inc. (“Yunji” or the “Company”) (NASDAQ: YJ).   Such investors are advised to contact Robert S. Willoughby at rswilloughby@pomlaw.com or 888-476-6529, ext. 9980.

The investigation concerns whether Yunji and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 


[Click here for information about joining the class action]

In May 2019, Yunji completed its initial public offering (“IPO”), in which the Company sold 11 million American Depositary Shares (“ADSs”) priced at $11 per share.  On August 22, 2019, Yunji issued a press release announcing its financial results for the second quarter of 2019.  The Company disclosed that its total revenues had decreased significantly from the same period in the prior year, citing “primarily . . . a decrease in revenues from sales of merchandise, which recognizes revenues on a gross basis, as the Company shifted part of merchandise sales to its marketplace platform, which recognizes revenues on a net basis.” 

On this news, Yunji’s stock price fell $4.55 per share, or 42.92%, over the following four trading sessions, closing at $6.05 per share on August 27, 2019.  Since the IPO, Yunji’s ADS price has closed as low as $4.88 per share.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT:

Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com
888-476-6529 ext. 9980

NASB Financial, Inc. Announces Financial Results

PR Newswire

GRANDVIEW, Mo., Dec. 13, 2019 /PRNewswire/ — NASB Financial, Inc. (the “Company”) (OTCQX: NASB) announced today net income for the quarter ended September 30, 2019, of $14,004,000 or $1.90 per share.  This compares to net income of $13,328,000 or $1.80 per share for the quarter ended June 30, 2019, and $8,477,000 or $1.15 per share for the quarter ended September 30, 2018. 

Net income for the year ended September 30, 2019, was $43,167,000 or $5.85 per share.  This compares to net income of $29,131,000 or $3.94 per share for the year ended September 30, 2018.  The increase in earnings for the current year was primarily attributable to higher asset balances, increased mortgage banking activity, and a one-time gain from the sale of real estate owned by the Company.

NASB Financial, Inc. is a unitary thrift holding company for North American Savings Bank, F.S.B. (“NASB”), a community bank headquartered in Grandview, Missouri.  Since 1927, NASB has been serving the financial needs of customers by providing an array of personal banking and lending products in the Kansas City metro area.  Nationwide, NASB offers competitive residential and commercial mortgages with the safety and security of a Federal institution.  For more information, visit nasb.com.

(Financial Highlights Schedule Attached)


NASB Financial, Inc.


Financial Highlights

(Dollars in thousands, except per share data)

Three Months Ended

Twelve Months Ended

  9/30/19

 6/30/19

  9/30/18

9/30/19

9/30/18


EARNINGS DATA:

Net interest income

$

22,378

20,795

20,916

82,672

77,928

Provision for loan losses

275

1,750

2,625

Non-interest income

20,826

17,627

8,855

56,286

37,299

Non-interest expense

24,532

20,651

18,001

79,652

69,991

Income tax expense

4,668

4,443

3,018

14,389

13,480

     Net income

$

14,004

13,328

8,477

43,167

29,131


FINANCIAL CONDITION DATA:

Total assets

$

2,605,225

2,451,353

2,060,361

2,605,225

2,060,361

Total loans held for sale

420,428

289,818

123,245

420,428

123,245

Total loans held for investment and 
mortgage-backed securities, net

1,911,521

1,900,404

1,717,358

1,911,521

1,717,358

Customer and brokered deposit accounts

1,828,972

1,709,492

1,536,226

1,828,972

1,536,226

Stockholders’ equity

262,267

251,681

231,681

262,267

231,681


FINANCIAL RATIOS AND PER SHARE DATA:

Book value per share

$

35.56

34.08

31.37

35.56

31.37

Earnings per share

1.90

1.80

1.15

5.85

3.94

Cash dividends paid per share

0.50

0.50

0.50

2.00

3.82

Return on assets (annualized net income
divided by total average assets)

2.22%

2.25%

1.67%

1.85%

1.41%

Return on equity (annualized net income
 divided by average stockholders’ equity)

21.80%

21.66%

14.79%

17.48%

12.54%

Weighted average shares outstanding

7,381,378

7,384,851

7,384,851

7,383,976

7,384,604

 

Cision View original content:http://www.prnewswire.com/news-releases/nasb-financial-inc-announces-financial-results-300974842.html

SOURCE NASB Financial, Inc.