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American Century Investments First To Launch Active ESG Exchange Traded Funds Through NYSE Structure

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KANSAS CITY, Mo., July 15, 2020 /PRNewswire/ — To provide additional choices for investors seeking actively-managed Environmental, Social and Governance (ESG) strategies in a lower-cost ETF vehicle, American Century Investments today launched two active ESG ETFs utilizing the New York Stock Exchange (NYSE) AMSSM (Actively Managed SolutionSM), the first-time use of the new active ETF structure.  Geared to financial professionals, American Century Sustainable Equity ETF (ESGA) and American Century Mid Cap Growth Impact ETF (MID), with total expense ratios of 0.39% and 0.45%, respectively, will use the global asset manager’s time-tested stock selection processes with an ESG overlay.




These ETFs are different from traditional ETFs.





Traditional ETFs tell the public what assets they hold each day. These ETFs will not.
This may create additional risks for your investment. For example:






You may have to pay more money to trade the ETFs’ shares. These ETFs will provide less information to traders, who tend to charge more for trades when they have less information.







The price you pay to buy ETF shares on an exchange may not match the value of the ETF’s portfolio. The same is true when you sell shares. These price differences may be greater for these ETFs compared to other ETFs because it provides less information to traders.







These additional risks may be even greater in bad or uncertain market conditions.







MID and ESGA will publish on their website each day a “Proxy Portfolio” designed to help trading in shares of the ETF. While the Proxy Portfolio includes some of the ETF’s holdings, it is not the ETF’s actual portfolio.






The differences between these ETFs and other ETFs may also have advantages. By keeping certain information about the ETFs secret, these ETF may face less risk that other traders can predict or copy its investment strategy. This may improve the ETFs’ performance. If other traders are able to copy or predict the ETFs’ investment strategy, however, this may hurt the ETFs’ performance.






For additional information regarding the unique attributes and risks of these ETFs, see the additional risk discussion at the end of this material. 





“We believe these new ESG solutions offer investors the ‘best of both worlds:’ the alpha potential of active management with the advantages of ETFs, including low costs, tax efficiency and liquidity,” said Ed Rosenberg, head of ETFs for the firm.  “This continues the next evolution of the ETF industry, and it expands opportunities for clients by enabling access to managers and strategies that had previously not been available, particularly in an ESG strategy.”

The launch of American Century Sustainable Equity ETF (ESGA) and American Century Mid Cap Growth Impact ETF (MID)  comes on the heels of the spring launch of American Century Focused Large Cap Value ETF (FLV) and American Century Focused Dynamic Growth ETF (FDG), the first two semi-transparent active ETFs in the industry.  

The new ETFs enable the firm to dovetail its active management heritage with its unique perspective on ESG and impact investing, according to Jonathan Thomas, American Century Investments’ chief executive officer. 

“In many respects, American Century remains a natural destination for investors wanting to have a positive impact on society by including actively managed ESG ETF strategies in their portfolios,” Thomas said. “Our ESG solutions continue to grow, while our ownership model results in more than 40 percent of our annual profits in the form of dividends being directed to funding medical research.” 

American Century Sustainable Equity ETF (ESGA) invests in large-cap stocks with improving business fundamentals and sustainable corporate behaviors. The portfolio managers take an ESG leaders or “best-in-class” approach to ESG integration by seeking to invest primarily in companies they believe manage ESG risks and opportunities better than their sector peers.  The portfolio is permitted to invest in all sectors or industries (excluding tobacco) but intentionally seeks to have a larger weight, relative to the S&P 500, in companies viewed as ESG leaders in their sectors while avoiding or holding an underweight position in companies viewed as ESG laggards.  The fund is managed by Gregory Woodhams, CFA, Joseph Reiland, CFA, Justin Brown, CFA, Robert Bove and Rene Casis.

American Century Mid Cap Growth Impact ETF (MID), the first and only active ESG ETF in its category, invests in high-quality mid-cap growth-oriented companies believed to offer attractive investment returns and positive impact on society. Managers use a top-down and bottom-up stock selection process utilizing proprietary fundamental research to invest in a portfolio of primarily U.S. mid cap companies exhibiting durable business improvement underpinned by long-term thematic drivers. The portfolio management team creates a macro and bottom-up investment thesis for each holding and using a risk-aware framework, constructs a portfolio that emphasizes stock selection and alignment with UN Sustainable Development Goals (SDGs).  The fund is managed by Rob Brookby, Nalin Yogasundram and Rene Casis.

The ETFs utilizing the NYSE AMSSM will provide daily disclosures of a “proxy portfolio” with different composition and weightings than the fund’s actual holdings. The proxy portfolio reflects the economic exposures and risk characteristics of the ETF’s actual portfolio. The proxy portfolio closely replicates the intraday performance of the actual fund while mitigating the risk of front-running and other activities potentially detrimental to an actively managed ETF and its investors.

The funds will be primary listed on NYSE Arca, Inc. with Citadel Securities, LLC as the lead market maker and State Street as the custodian.

American Century Investments is a leading global asset manager focused on delivering investment results and building long-term client relationships while supporting research that can improve human health and save lives. Founded in 1958, American Century Investments’ 1,400 employees serve financial professionals, institutions, corporations and individual investors from offices in New York; London; Hong Kong; Frankfurt; Sydney; Los Angeles; Mountain View, Calif.; and Kansas City, Mo. Jonathan S. Thomas is president and chief executive officer, and Victor Zhang serves as chief investment officer. Delivering investment results to clients enables American Century Investments to distribute over 40 percent of its dividends to the Stowers Institute for Medical Research, a 500-person, non-profit basic biomedical research organization. The Institute owns more than 40 percent of American Century Investments and has received dividend payments of $1.6 billion since 2000. For more information about American Century Investments, visit americancenturyetfs.com.

You should consider the fund’s investment objectives, risks, charges and expenses carefully before you invest. The fund’s prospectus or summary prospectus, which can be obtained by visiting americancentury.com, contains this and other information about the fund, and should be read carefully before investing.

Exchange Traded Funds (ETFs) are bought and sold through exchange trading at market price (not NAV), and are not individually redeemed from the fund. Shares may trade at a premium or discount to their NAV in the secondary market. Brokerage commissions will reduce returns.

These funds are actively managed ETFs that do not seek to replicate the performance of a specified index. To determine whether to buy or sell a security, the portfolio managers consider, among other things, various fund requirements and standards, along with economic conditions, alternative investments, interest rates and various credit metrics. If the portfolio manager considerations are inaccurate or misapplied, the fund’s performance may suffer.

Investment return and principal value of security investments will fluctuate. The value at the time of redemption may be more or less than the original cost. Past performance is no guarantee of future results.

Because the shares are traded in the secondary market, a broker may charge a commission to execute a transaction in shares, and an investor also may incur the cost of the spread between the price at which a dealer will buy shares and the somewhat higher price at which a dealer will sell shares.

Important Disclosures – MID, ESGA

MID is classified as non-diversified. Because it is non-diversified, it may hold large positions in a small number of securities. To the extent it maintains such positions; a price change in any one of those securities may have a greater impact on the fund’s share price than if it were diversified.

A strategy or emphasis on environmental, social and governance factors (“ESG”) may limit the investment opportunities available to a portfolio. Therefore, the portfolio may underperform or perform differently than other portfolios that do not have an ESG investment focus. A portfolio’s ESG investment focus may also result in the portfolio investing in securities or industry sectors that perform differently or maintain a different risk profile than the market generally or compared to underlying holdings that are not screened for ESG standards.

Proxy Portfolio Risk – The goal of the Proxy Portfolio is, during all market conditions, to track closely the daily performance of the Actual Portfolio and minimize intra-day misalignment between the performance of the Proxy Portfolio and the performance of the Actual Portfolio. The Proxy Portfolio is designed to reflect the economic exposures and the risk characteristics of the Actual Portfolio on any given trading day.

  • The Proxy Portfolio methodology is novel and not yet proven as an effective arbitrage mechanism. The effectiveness of the Proxy Portfolio as an arbitrage mechanism is contingent upon, among other things, the fund’s factor model analysis creating a proxy portfolio that performs in a manner substantially identical to the performance of the fund’s actual portfolio. While the Proxy Portfolio may include some of the fund’s holdings, it is not the fund’s Actual Portfolio. ETFs trading on the basis of a published Proxy Portfolio may exhibit wider premiums and discounts, bid/ask spreads, and tracking error than other ETFs using the same investment strategies that publish their portfolios on a daily basis, especially during periods of market disruption or volatility. Therefore, shares of the fund may cost investors more to trade than shares of a traditional ETF.
  • Each day the fund calculates the overlap between the holdings of the prior Business Day’s Proxy Portfolio compared to the Actual Portfolio (Proxy Overlap) and the difference, in percentage terms, between the Proxy Portfolio per share NAV and that of the Actual Portfolio (Tracking Error). If the Tracking Error becomes large, there is a risk that the performance of the Proxy Portfolio may deviate from the performance of the Actual Portfolio.
  • The fund’s Board of Trustees monitors its Tracking Error and bid/spread. If deviations become too large, the Board will consider the continuing viability of the fund, whether shareholders are being harmed, and what, if any, corrective measures would be appropriate. See the Statement of Additional Information for further discussion of the Board’s monitoring responsibilities.
  • Although the fund seeks to benefit from keeping its portfolio information secret, market participants may attempt to use the Proxy Portfolio to identify a fund’s trading strategy, which if successful, could result in such market participants engaging in certain predatory trading practices that may have the potential to harm the fund and its shareholders.

Premium/Discount Risk – Publication of the Proxy Portfolio is not the same level of transparency as the publication of the full portfolio by a fully transparent active ETF. Although the Proxy Portfolio is intended to provide investors with enough information to allow for an effective arbitrage mechanism that will keep the market price of the fund at or close to the underlying net asset value (NAV) per share of the fund, there is a risk (which may increase during periods of market disruption or volatility) that market prices will vary significantly from the underlying NAV of the fund. This means the price paid to buy shares on an exchange may not match the value of the fund’s portfolio. The same is true when shares are sold.

Trading Issues Risk – If securities representing 10% or more of the fund’s Actual Portfolio do not have readily available market quotations, the fund will promptly request that the Exchange halt trading in the fund’s shares. Trading halts may have a greater impact on this fund compared to other ETFs due to the fund’s nontransparent structure. If the trading of a security held in the fund’s Actual Portfolio is halted, or otherwise does not have readily available market quotations, and the Advisor believes that the lack of any such readily available market quotations may affect the reliability of the Proxy Portfolio as an arbitrage vehicle, or otherwise determines it is in the best interest of the fund, the Advisor promptly will disclose on the fund’s website the identity and weighting of such security for so long as such security’s trading is halted or otherwise does not have readily available market quotations and remains in the Actual Portfolio.

Authorized Participant Concentration Risk – Only an authorized participant may engage in creation or redemption transactions directly with the fund. The fund may have a limited number of institutions that act as authorized participants. To the extent that these institutions exit the business or are unable to proceed with creation and/or redemption orders with respect to the fund and no other authorized participant is able to step forward to process creation and/or redemption orders, fund shares may trade at a discount to net asset value (NAV) and possibly face trading halts and/or delisting. This risk may be more pronounced in volatile markets, potentially where there are significant redemptions in ETFs generally. The fact that the fund is offering a novel and unique structure may affect the number of entities willing to act as Authorized Participants. During times of market stress, Authorized Participants may be more likely to step away from this type of ETF than a traditional ETF.

Actively Managed SolutionSM, AMSSM is a service mark of NYSE Group, Inc. or its affiliates (“NYSE”) and has been licensed for use by American Century Investment Management, Inc. (“Licensee”) in connection with American Century Sustainable Equity ETF and American Century Mid Cap Growth Impact ETF (the “Funds”).  Neither Licensee nor the Funds are sponsored, endorsed, sold or promoted by NYSE.  NYSE makes no representations or warranties regarding Licensee or the Funds or the ability of the AMSSM to track the intra-day performance of any fund.

NYSE MAKES NO EXPRESS OR IMPLIED WARRANTIES, AND HEREBY EXPRESSLY DISCLAIMS ALL WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO AMSSM OR ANY DATA INCLUDED THEREIN.  IN NO EVENT SHALL NYSE HAVE ANY LIABILITY FOR ANY SPECIAL, PUNITIVE, INDIRECT, OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS), EVEN IF NOTIFIED OF THE POSSIBILITY OF SUCH DAMAGES.

Alpha is typically used to represent the value added or subtracted by active investment management strategies. It shows how an actively managed investment portfolio performed compared with the expected portfolio returns produced simply by benchmark volatility (beta) and market changes. A positive alpha shows that an investment manager has been able to capture more of the upside movement in the benchmark while softening the downswings. A negative alpha means that the manager’s strategies have caught more benchmark downside than upside. 

Important Disclosures – FLV, FDG

FLV and FDG may invest in a limited number of companies, which carries more risk because changes in the value of a single company may have a more significant effect, either negative or positive on the fund’s value. 

The Verified Intraday Indicative Value – Unlike traditional ETFs, the fund does not tell the public what assets it holds each day. Instead, the fund provides a verified intraday indicative value (VIIV), calculated and disseminated every second throughout the trading day by the Cboe BZX Exchange, Inc. (Listing Exchange) or by market data vendors or other information providers. It is available on websites that publish updated market quotations during the trading day, by searching for the fund’s ticker plus the extension .IV, though some websites require more unique extensions. For example, the VIIV can be found on Yahoo Finance (https://finance.yahoo.com) by typing “^FLV-IV” (for Focused Large Cap Value ETF) or “^FDG-IV” (for Focused Dynamic Growth ETF) in the search box labeled “Quote Lookup.” The VIIV is based on the current market value of the securities in the fund’s portfolio on that day. The VIIV is intended to provide investors and other market participants with a highly correlated per share value of the underlying portfolio that can be compared to the current market price. To calculate the VIIV, the fund employs two separate calculation engines to provide two independently calculated sources of intraday indicative values (calculation engines). The fund then uses a pricing verification agent to continuously compare the data from both the calculations engines on a real time basis. If during the process of real time price verification, the indicative values from the calculation engines differ by more than 25 basis points for 60 consecutive seconds, the pricing verification agent will alert the advisor, and the advisor will request that the Listing Exchange halt trading of the fund’s shares until the two indicative values come back into line. This “circuit breaker” is designed to prevent the VIIV from reflecting outlier prices. The specific methodology for calculating the fund’s VIIV is available on the fund’s website.

Portfolio Transparency Risk – The VIIV is intended to provide investors with enough information to allow for an effective arbitrage mechanism that will keep the market price of the fund’s shares trading at or close to the underlying net asset value (NAV) per share of the fund. There is, however, a risk, which may increase during periods of market disruption or volatility, that market prices will vary significantly from the underlying NAV of the fund. Similarly, because the fund’s shares trade on the basis of a published VIIV, they may trade at a wider bid/ask spread than shares of ETFs that publish their portfolios on a daily basis, especially during periods of market disruption or volatility, and therefore, may cost investors more to trade. Although the fund seeks to benefit from keeping its portfolio information secret, some market participants may attempt to use the VIIV to identify the fund’s trading strategy, which if successful, could result in such market participants engaging in certain predatory trading practices that may have the potential to harm the fund and its shareholders. The fund’s website will contain a historical comparison of each business day’s final VIIV to that business day’s NAV.

Early Close / Trading Halt Risk – Trading in fund shares on the Listing Exchange may be halted in certain circumstances. An exchange or market may close early or issue trading halts on portfolio securities. In times of market volatility, if trading is halted in some of the securities that the fund holds, there may be a disconnect between the market price of those securities and the market price of the fund. In addition, if at any time the securities representing 10% or more of the fund’s portfolio become subject to a trading halt or otherwise do not have readily available market quotations, the fund’s advisor will request the Listing Exchange to halt trading on the fund, meaning that investors would not be able to trade their shares. Also, if there is a circuit breaker event, as described above, the fund’s advisor will request the Listing Exchange to halt trading. During any such trading halt, the VIIV would continue to be calculated and disseminated. Trading halts may have a greater impact on the fund than traditional ETFs because of its lack of transparency. Additionally, the fund’s advisor monitors the bid and ask quotations for the securities the fund holds, and, if it determines that such a security does not have readily available market quotations (such as during an extended trading halt), it will post that fact and the name and weighting of that security in the fund’s VIIV calculation on the fund’s web site. This information should permit market participants to calculate the effect of that security on the VIIV calculation, determine their own fair value of the disclosed portfolio security, and better judge the accuracy of that day’s VIIV for the fund. An extended trading halt in a portfolio security could exacerbate discrepancies between the VIIV and the fund’s NAV.

Authorized Participant / Authorized Participant Representative Concentration Risk – The fund issues and redeems shares that have been aggregated into blocks of 5000 shares or multiples thereof (Creation Units) to authorized participants who have entered into agreements with the fund’s distributor. (Authorized Participants). The creation and redemption process for the fund occurs through a confidential brokerage account (Confidential Account) with an agent, called an AP Representative, on behalf of an Authorized Participant. Each day, the AP Representative will be given the names and quantities of the securities to be deposited, in the case of a creation, or redeemed, in the case of a redemption (Creation Basket), allowing the AP Representative to buy and sell positions in the portfolio securities to permit creations or redemptions on the Authorized Participant’s behalf, without disclosing the information to the Authorized Participant. The fund may have a limited number of institutions that act as Authorized Participants and AP Representatives, none of which are obligated to engage in creation or redemption transactions. To the extent that these institutions exit the business or are unable to proceed with creation and/or redemption orders with respect to the fund and no other Authorized Participant is able to step forward to process creation and/or redemption orders, fund shares may trade at a discount to NAV and possibly face trading halts and/or delisting. This risk may be more pronounced in volatile markets, potentially where there are significant redemptions in ETFs generally. The fact that the fund is offering a novel and unique structure may affect the number of entities willing to act as Authorized Participants and AP Representatives. During times of market stress, Authorized Participants may be more likely to step away from this type of ETF than a traditional ETF.

Foreside Fund Services, LLC, Distributor, not affiliated with American Century Investment Services, Inc.

©2020 American Century Proprietary Holdings, Inc. All rights reserved.

Contact:

Laura Kouri


(816) 516-7729

SOURCE American Century Investments

Related Links

http://www.americancenturyetfs.com

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Press Release

The Pressing Need for Early Detection of Mucormycosis during COVID-19

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Fapon Biotech calls for cooperation with academic and industry partners in developing mucormycosis diagnostic tests to ease the challenge by sharing the abilities of upstream raw material development platforms and downstream reagent application platforms.

DONGGUAN, China, June 21, 2021 /PRNewswire/ — Mucormycosis or black fungus, a devastating infection that soars in India during COVID-19 has seized global attention. Recently, the country’s mucormycosis cases reached over 57,150 and resulted in 54% mortality. Apart from the association with high diabetes prevalence in India, COVID-19 infected countries (Pakistan, Russia, Nepal, Chile, Brazil, etc.) have also described the same issue, areas with high diabetes and COVID-19 infection rates should be alarmed.

Fapon Biotech calls for cooperation with academic and industry partners in developing mucormycosis diagnostic tests to ease the challenge by sharing the abilities of upstream raw material development platforms and downstream reagent application platforms.

Unfortunately, mucormycosis is always being diagnosed late with prolonged COVID-19 healthcare burdens that deteriorate the situation. As a company making continuous research and contribution to the world’s major infectious diseases with the mission to Enable Disease Identification Earlier, More Accurate, Convenient and Affordable, Fapon Biotech Inc. (Fapon Biotech) calls for cooperation with academic and industry partners in developing mucormycosis diagnostic tests to ease the challenge by sharing the abilities of upstream raw material development platforms and downstream reagent application platforms.

Fapon Biotech is one of the mainstream COVID-19 reagent raw material suppliers with proven experiences helping partners to launch accredited COVID-19 reagents in a short time. The company has over 1000 IVD partners worldwide with more than 10 years of business operation in India. Its technology platforms can match the R&D process from partners easily and provide supports from biomarker discovery to commercialization. Through different application platforms of Fapon Biotech (Colloidal Gold/Immunofluorescence/ELISA/CLIA/Latex-Enhanced Immunoturbidimetry/PCR/etc.), biomarkers can quickly complete the process of application development. For partners encountering production challenges, OEM and contract manufacturing services with the capacity reaching hundreds of grams of each batch are available. Because of a strong relationship with laboratories and IVD manufacturers in India, cooperating with Fapon Biotech will have the access to more resources and commercial opportunities, such as clinical samples for research and product validation, technology iterations, product launch and promotion, etc.

As the virus continues its mutation and triggers diseases like mucormycosis to complicate the situation, rapid responses via global cooperation will be crucial for areas with overwhelmed healthcare burdens. Fapon Biotech is committed to fueling the advancement of COVID-19 diagnosis through collaborations with international IVD partners.

About Fapon Biotech

Fapon Biotech was founded in 2001. Guided by the mission of “Enable Disease Identification Earlier, More Accurate, Convenient and Affordable,” the company focuses on the future needs of biotechnology developments and provides global diagnostic companies with high-performance IVD reagent raw materials, such as antigens, antibodies, and enzymes, as well as one-stop solutions with instrument and reagent services.

Photo – https://mma.prnewswire.com/media/1537054/Fapon_Biotech.jpg

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Press Release

RedHill Biopharma Announces Presentation of Positive Oral Opaganib Phase 2 Data in COVID-19

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RedHill Biopharma logo

Positive U.S. Phase 2 safety and efficacy data for opaganib, a leading novel, oral, dual-mechanism drug candidate for moderate-to-severe COVID-19, presented at the World Microbe Forum

Opaganib was associated with a reduction in the need for supplemental oxygen support, earlier time to discharge from hospital and was well tolerated

Opaganib’s global 475-patient Phase 2/3 study is fully enrolled, with study completion expected in the coming weeks

Opaganib is host-targeted and expected to be effective against emerging viral variants

TEL AVIV, Israel and RALEIGH, NC, June 21, 2021 /PRNewswire/ — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced presentation of the positive Phase 2 safety and efficacy data for oral opaganib (Yeliva®, ABC294640)[1] in hospitalized patients with COVID-19 pneumonia at the World Microbe Forum (WMF) 2021 (poster #: 5574).

RedHill Biopharma logo

Results and post hoc analyses of data from the 40-patient U.S. Phase 2 study were presented in a poster entitled, “Opaganib, an Oral Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: A Randomized, Double-blind, Placebo-controlled Phase 2A Study, in Adult Subjects Hospitalized with SARS-CoV-2 Positive Pneumonia (NCT: 04414618)“[2]. Patients in the study were randomized to receive either opaganib or placebo in addition to standard of care (SoC), predominantly including dexamethasone and/or remdesivir. Findings include:

  • 50% of patients treated with opaganib (n=22) reached room air by Day 14 compared to 22% in the placebo group (n=18). The benefit of reaching room air by Day 14 for patients on opaganib was maintained regardless of whether the patients were receiving dexamethasone and/or remdesivir
  • 86.4% of patients treated with opaganib were discharged from hospital by Day 14 compared to 55.6% of patients treated with placebo
  • Median time to discharge was 6 days for the opaganib group compared to 7.5 days for the placebo group
  • 81.8% of opaganib patients achieved a 2-point improvement in the WHO Ordinal Scale compared to 55.6% of patients in the placebo group – achieved in a median time of 6 days versus 7.5 days, respectively
  • No significant differences in safety-related measures between the two groups (with diarrhea being the main treatment-emergent difference in tolerability)

“The need for an effective oral therapy to treat COVID-19 is clear. Such a therapy would greatly improve our ability to manage this pandemic,” said Kevin Winthrop, MD, MPH, Professor of Infectious Diseases at Oregon Health & Science University, who presented the findings at WMF. “These data, from this proof-of-concept clinical study of opaganib in patients with severe COVID-19, suggest a potential role of SK2 inhibition in combating the effects of this virus. With much more data on opaganib expected in the coming weeks, we could make some real progress toward having access to a much-needed oral therapy for patients who currently have a paucity of options available to them.”

“Presentation of these positive data from our exploratory Phase 2 study support our growing confidence that opaganib could be the first novel, oral therapy to demonstrate efficacy in the treatment of COVID-19 in a large late-stage study. With the recent completion of enrollment of our 475-patient global Phase 2/3 study, we will have a clearer picture of that in the very near future,” said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. “Opaganib acts on both the cause and effect of COVID-19 via a unique dual antiviral and anti-inflammatory mode of action. Being host-targeted, opaganib is also expected to maintain effect against the emerging SARS-CoV-2 variants, which continue to threaten the progress being made against the pandemic and underscore the urgent need for effective COVID-19 therapeutics.”

The global 475-patient Phase 2/3 study of opaganib in severe COVID-19 has been approved in 10 countries and completed enrollment, through 57 participating sites, on June 6th. The primary endpoint of the study is the proportion of patients breathing room air without oxygen support by Day 14. Additional important outcome measures, such as time to discharge from hospital, improvement according to the World Health Organization Ordinal Scale for Clinical Improvement and incidence of intubation and mortality, will also be captured in the follow-up period of up to 6 weeks. The study received four independent DSMB recommendations to continue following unblinded safety reviews and a futility review. Additionally, an evaluation of the blinded blended intubation and mortality rates to date was encouraging as compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations[3].

About Opaganib (Yeliva®, ABC294640)

Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity, that is host-targeted and is therefore expected to be effective against emerging viral variants. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study, which recently completed enrollment, and has demonstrated positive safety and efficacy signals in preliminary top-line data from the 40-patient U.S. Phase 2 study.

Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib’s potential to ameliorate inflammatory lung disorders, such as pneumonia, and has shown decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[4].

The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

About RedHill Biopharma    

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[5], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[6], and Aemcolo® for the treatment of travelers’ diarrhea in adults[7]. RedHill’s key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a firstinclass SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.         

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the delay in last patient visit and top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib may not be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that opaganib will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia®; (v) the Company’s ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company’s Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

 

Company contact:

Adi Frish

Chief Corporate & Business Development Officer

RedHill Biopharma

+972-54-6543-112

adi@redhillbio.com

Media contacts:

U.S.: Bryan Gibbs, Finn Partners

+1 212 529 2236

bryan.gibbs@finnpartners.com

UK: Amber Fennell, Consilium

+44 (0) 7739 658 783  

fennell@consilium-comms.com

 

[1] Opaganib is an investigational new drug, not available for commercial distribution.

[2] Opaganib, an Oral Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: A Randomized, Double-blind, Placebo-controlled Phase 2A Study, in Adult Subjects Hospitalized with SARS-CoV-2 Positive Pneumonia (NCT: 04414618). K. L. Winthrop, A. W. Skolnick, A. M. Rafiq, S. H. Beegle, J. Suszanski, G. Koehne, O.Barnett-Griness, A. Bibliowicz, R. Fathi, P. Anderson, G. Raday, G. Eagle, V. Katz Ben-Yair, H. S. Minkowitz, M. L. Levitt, M. S. Gordon

[3] Based on preliminary blinded blended data from 463 patients. The Company did not conduct a head-to-head comparison study in the same patient population. The theoretical comparison between the global Phase 2/3 study with opaganib and reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations, serves as a general benchmark and should not be construed as a direct and/or applicable comparison as if the Company conducted a head-to-head comparison study.

[4] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

[5] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

[6] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

[7] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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Press Release

Pandora Boosts Online Sales by Transforming Its Global Omnichannel e-Commerce with IBM Sterling Supply Chain Software

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Pandora, a leading designer, manufacturer and marketer of hand-finished jewelry, is using IBM Sterling Order Management for improved real-time inventory visibility. Photo courtesy Pandora.

One of the world’s largest jewelry brands by volume uses IBM Sterling Order Management on Cloud to revamp its fulfillment capabilities and customer experience

ARMONK, N.Y., June 21, 2021 /PRNewswire/ — IBM (NYSE: IBM) has worked with Pandora (NASDAQ: PNDORA), a leading designer, manufacturer and marketer of hand-finished jewelry, to help Pandora transform and scale its global omnichannel e-commerce capabilities with IBM Sterling Order Management. Pandora, one of the world’s largest jewelry brands, was able to double its online sales in 2020 and is now leading the jewelry industry with improved real-time inventory visibility to better manage growing demand.

Pandora, a leading designer, manufacturer and marketer of hand-finished jewelry, is using IBM Sterling Order Management for improved real-time inventory visibility. Photo courtesy Pandora.

Pandora’s focus on innovating new customer experiences included using IBM Sterling Order Management to help to increase the company’s supply chain resiliency and business agility, and better mitigate disruptions and risk. By automating more of their order orchestration across channels, they also have opportunity to improve the sustainability and resiliency of their supply chain operations with more efficient delivery.

“Over the past couple of years, Pandora has made significant investments in digital capabilities and data, and we have consolidated, simplified and modernized the technology stack to bring digital and store technology closer together and closer to the customer,” said Jim Cruickshank, VP of Digital Development & Retail Technology, Pandora. “Our mission is about creating a personal experience and we’ve instituted massive platform changes with IBM Sterling and Salesforce to enable new digital-first capabilities that are much more individualized, localized and connected across channels and markets.”

Pandora’s entry into e-commerce over the last six years most recently led them to consolidate legacy technologies while deploying the new order management solution across its key markets. Using IBM Sterling Order Management as its backend for omnichannel fulfillment and Salesforce Commerce Cloud for e-commerce, Pandora created a seamless shopping experience across channels. By automating order orchestration processes, store associates and virtual customer service representatives are able to have an end-to-end view across inventory, order and delivery status to help meet consumer expectations.

To support this ambitious objective, Pandora established a Digital Hub in Copenhagen, Denmark, with dedicated digital, data and tech teams that have played a vital role in the solution’s quick deployment entirely remotely. As the pandemic forced Pandora to temporarily close most of its 2,700 stores, the digital investments in supply chain efficiency helped fuel the company’s e-commerce success. In addition to some of the go-to fulfillment options many retailers offered such as buy online pickup in store (BOPIS) and endless aisle, Pandora also introduced more innovative approaches such as virtual queuing for stores and AR-based virtual trials of products to help drive more immersive customer engagement.

“The global disruption every industry experienced as all forms of commerce were severely impacted by the pandemic was especially challenging for organizations with disconnected distributed order management systems and limited scalability,” said Jordan Speer, Research Manager – Global Supply Chain, IDC Retail Insights. “This vulnerability created a push to more quickly advance technology adoption that helps retailers better respond to fluctuating consumer dynamics. To meet this changing demand, enterprises are looking to harness new tools to achieve increased levels of supply chain resilience and efficiency while also allowing for more virtual interactions.”

Pandora’s detailed view on order and order lines as well as near real-time inventory management helped to improve insights throughout their systems chain spanning warehouse management solutions, e-commerce and customer contact center. This was further enabled with increased automation from self-service capabilities and the use of chatbots aiding customer support functions as Pandora experienced a massive increase in order volumes.

“The lifeblood of the global economy, consumer behavior, has significantly shifted and will continue to evolve with businesses needing to quickly adapt to new preferences and needs. To address this shift, leading retailers like Pandora rely on innovation to increase their business agility by enabling and scaling sustainable supply chain operations using AI and cloud,” said Kareem Yusuf, General Manager, AI Applications and Blockchain, IBM. “Pandora’s experience shows that they can stay competitive as business and technology leaders are finding new ways to create differentiated customer experiences that protect their enterprises from disruptions to help mitigate risk and accelerate growth.”

To hear more about Pandora’s omnichannel experience using IBM Sterling Order Management view their THINK 2021 keynote detailing how they continue to execute on their strategic initiatives by navigating one of the world’s greatest supply chain disruption.

About Pandora

Pandora designs, manufactures and markets hand-finished jewelry made from high-quality materials at affordable prices. Pandora jewellery is sold in more than 100 countries through more than 6,700 points of sale, including around 2,700 concept stores.

Headquartered in Copenhagen, Denmark, Pandora employs 26,000 people worldwide and crafts its jewelry at two LEED certified facilities in Thailand using mainly recycled silver and gold. The company plans to be carbon neutral by 2025 and has joined the Science Based Targets initiative to reduce emissions across its full value chain. Pandora is listed on the Nasdaq Copenhagen stock exchange and generated sales of DKK 19.0 billion (EUR 2.5 billion) in 2020.

About IBM Sterling Supply Chain

IBM Sterling Supply Chain solutions empower IT and supply chain professionals with greater visibility, transparency and trust to proactively predict and mitigate disruption, improve B2B information flow, and optimize inventory utilization and fulfillment. Learn how our AI- and blockchain-enabled solutions help you build an intelligent, self-correcting supply chain at www.ibm.com/supply-chain.

Contacts:

Heli Koenkyto

Heli.Koenkyto@ibm.com

Erik Mason

erik.mason@ibm.com

IBM Corporation logo.

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