Thermalito Union Elementary School District Approves Purchase of Six All-Electric School Buses From GreenPower

PR Newswire


California Schools Continue Transition to Zero-Emissions Transportation

LOS ANGELES, Nov. 13, 2020 /PRNewswire/ — GreenPower Motor Company Inc. (NASDAQ:GP) (TSXV:GPV) (“GreenPower”) a leading manufacturer and distributor of zero emissions electric powered vehicles serving the cargo delivery, shuttle, transit, and school bus markets, today announced the sale of six electric school buses (B.E.AS.T.), to Thermalito Union Elementary School District through Greenpower’s national distributor Creative Bus Sales.

The B.E.A.S.T. is a purpose-built Type D Battery Electric School bus with a leading class range of up to 150 miles and a 194.5kWh battery pack. The vehicles can charge up to 20KW on standard J1772 protocol and has CCS1 fast charging, with additional standard features like air ride suspension, pass through storage, and air disk brakes. The B.E.A.S.T. offers a Monocoque chassis design built from the ground up to be battery electric.

Butte County Air Quality Management District (AQMD) will be funding the purchase of one school bus through their clean vehicle incentive program. AQMD’s mission is to protect the community and the environment of Butte County from the harmful effects of air pollution. Their clean vehicle incentive programs offer grants to aid in the reduction of emissions and the impact of air quality.

Five of GreenPower’s electric school buses will be funded through the California Clean Energy Jobs Act (CEC) Prop 39. The CEC Prop 39, has awarded schools more than $1.7 billion over the last five years to plan and install energy efficiency upgrades, clean energy generation measures, and zero emissions transportation.

Brendan Riley, President of GreenPower commented, “The sale of six units to the Thermalito Union School District is a great example of how GreenPower is working with customers and our sales partners to leverage multiple incentive programs to bring our all-electric school bus to market. This is a trend we expect to accelerate within California, then spread to other states as a template.”  Mr. Riley continued, “Our sales team has been working exhaustively to further our first mover advantage in the purpose built all-electric school bus market and we have high expectations as the transition to EV accelerates for the sector.”

Ryne Shetterly, VP of Sales and Marketing also commented, “Our purpose-built, zero-emissions, electric school bus was created with the health and safety of children in mind, as our all-electric school buses do not produce the toxic emissions produced by diesel buses. The B.E.A.S.T. showcases how overall safety and efficiency is our number one priority.” Mr. Shetterly adds, “Creative Bus Sales has worked hard with GreenPower to bring together demonstrations to school districts. The sales team at Creative Bus Sales is one of the best in the business and we will continue to proudly partner with them and push deals forward.”


About GreenPower Motor Company Inc. 

GreenPower designs, builds and distributes a full suite of high-floor and low-floor vehicles, including transit buses, school buses, shuttles, cargo van and a double decker. GreenPower employs a clean-sheet design to manufacture all-electric buses that are purpose built to be battery powered with zero emissions. GreenPower integrates global suppliers for key components, such as Siemens or TM4 for the drive motors, Knorr for the brakes, ZF for the axles and Parker for the dash and control systems. This OEM platform  allows GreenPower to meet the specifications of various operators while providing standard parts for ease  of maintenance and accessibility for warranty requirements. For further information go to www.greenpowerbus.com


Forward-Looking Statements 

This document contains forward-looking statements relating to, among other things, GreenPower’s business and operations and the environment in which it operates, which are based on GreenPower’s  operations, estimates, forecasts and projections. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events, and are therefore subject to  risks and uncertainties which could cause actual results to differ materially from the future results expressed  or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “upon”, “may”, “should”, “will”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to  predict. A number of important factors including those set forth in other public filings (filed under the Company’s profile on www.sedar.com) could cause actual outcomes and results to differ materially from those expressed in these forward-looking statements. Consequently, readers should not place any undue reliance on such forward-looking statements. In addition, these forward-looking statements relate to the date on which they are made. GreenPower disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. 

Neither the 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. © 2020 GreenPower Motor Company Inc. All rights reserved.

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SOURCE GreenPower Motor Company

Liminal Biosciences to Present at The Stifel Virtual Healthcare Conference

PR Newswire

LAVAL, QC and CAMBRIDGE, England, Nov. 13, 2020 /PRNewswire/ – Liminal BioSciences Inc. (Nasdaq: LMNL) (“Liminal BioSciences” or the “Company”), a clinical-stage biopharmaceutical company, announced that Bruce Pritchard, Chief Executive Officer at Liminal BioSciences is scheduled to present a company overview at The Stifel 2020 Virtual Healthcare Conference on Monday 16th November at 2:40-3:10 PM (EDT).

The presentation will be webcast live on the webcast page of the Investors & Media section of the Company’s website. An archived replay of the webcast will be available on the Company’s website for at least 7 days after the live event concludes.

About Liminal BioSciences Inc.

Liminal BioSciences is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing novel treatments for patients suffering from diseases of high unmet medical need, primarily related to fibrosis, including respiratory, liver and kidney diseases. Liminal BioSciences has a deep understanding of certain biological targets and pathways that have been implicated in the fibrotic process, including fatty acid receptors such as FFAR1, G-protein-coupled receptor 84 (GPR84), and peroxisome proliferator-activated receptors (PPARs). Our lead small molecule product candidate, fezagepras (PBI-4050), is expected to enter a Phase 1 clinical trial in Q4-2020 in the UK to evaluate multiple ascending doses in normal healthy volunteers, at daily dose exposures higher than those evaluated in our previously completed Phase 2 clinical trials. Fezagepras is expected to be further evaluated in a global Phase 2b clinical trial in patients with idiopathic pulmonary fibrosis (IPF) anticipated to be initiated in H2-2021. In addition, we expect to initiate a Phase 1b/2a clinical trial in the US of fezagepras for patients with high triglyceride levels (hypertriglyceridemia) in H2-2021.

Fezagepras has previously been granted Orphan Drug Designation by the FDA and the European Medical Agency (EMA) for the treatment of IPF. The treatment has also received a Promising Innovative Medicines (PIM) designation by the Medicines and Healthcare products Regulatory Agency (MHRA) for IPF.

Liminal BioSciences has also leveraged its experience in bioseparation technologies through its subsidiary Prometic Bioproduction Inc. to isolate and purify biopharmaceuticals from human plasma. Liminal BioSciences’ lead plasma-derived product candidate is Ryplazim®(plasminogen) (“Ryplazim®“), for which the Company, through its US subsidiary, Prometic Biotherapeutics Inc., resubmitted a BLA in September 2020 with the FDA seeking approval to treat patients with congenital plasminogen deficiency. The PDUFA target action date for this BLA filing is June 5, 2021. Ryplazim® has previously been granted Orphan Drug and Rare Pediatric Disease Designations by the FDA for the treatment of congenital plasminogen deficiency.

Prometic Plasma Resources, a subsidiary of Liminal BioSciences, has joined the CoVIg-19 Plasma Alliance to contribute to the acceleration of the development of a potential new therapy for COVID-19. Liminal BioSciences’ Canadian plasma collection center located in Winnipeg, Manitoba is licensed by the FDA and Health Canada, and is certified by the European Union and the Plasma Protein Therapeutics Association. Liminal BioSciences’ American plasma collection center located in Amherst, New York is licensed by the State of New York and its BLA submission is currently under review by the FDA.

Liminal BioSciences has active business operations in Canada, the United Kingdom and the United States.

Forward Looking Statement

This press release contains forward-looking statements about Liminal BioSciences’ objectives, strategies and businesses that involve risks and uncertainties. Forward–looking information includes statements concerning, among other things, statements regarding our clinical development plans for fezagepras, with respect to the timing for FDA review of the BLA for Ryplazim®, our plans for commercial launch of Ryplazim® in the United States if approved, our regulatory and commercial plans for Ryplazim® outside the United States, the potential of our product candidates and development of R&D programs and the nature and timing of initiation of clinical trials.

These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. At this stage, the product candidates of the Company have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include, but are not limited to, risks associated with FDA review, Liminal BioSciences’ ability to effectively establish a commercial organization, Liminal BioSciences’ ability to develop, manufacture, and successfully commercialize product candidates, if ever, the impact of the COVID-19 pandemic on its business operations, clinical development, regulatory activities and financial and other corporate impacts, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical trials, the ability of Liminal BioSciences to take advantage of business opportunities in the pharmaceutical industry, uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals and general changes in economic conditions. You will find a more detailed assessment of these risks, uncertainties and other risks that could cause actual events or results to materially differ from our current expectations in the filings the Company makes with the U.S. Securities and Exchange Commission and Canadian Securities Commissions filings and reports filings and reports, including in the Annual Report on Form 20-F, as amended, for the year ended December 31, 2019 and future filings and reports by the Company, from time to time. Such risks may be amplified by the COVID-19 pandemic and its potential impact on Liminal BioSciences’ business and the global economy. As a result, we cannot guarantee that any forward-looking statement will materialize. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof.  We assume no obligation to update any forward-looking statement contained in this Press Release even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations.

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SOURCE Liminal BioSciences Inc.

GAMCO Global Gold, Natural Resources & Income Trust Announces Expected Total Distributions of $0.36 Per Share for 2021

GAMCO Global Gold, Natural Resources & Income Trust Announces Expected Total Distributions of $0.36 Per Share for 2021

Declares Monthly Distributions of $0.03 Per Share

RYE, N.Y.–(BUSINESS WIRE)–
The Board of Trustees of GAMCO Global Gold, Natural Resources & Income Trust (NYSE American: GGN) (the “Fund”) approved the continuation of its policy of paying monthly cash distributions. The Board of Trustees declared cash distributions of $0.03 per share for each of January, February, and March 2021. This equates to an expected total annual 2021 distribution of $0.36 per common share. Based on current dynamics, the Fund may make distributions in excess of the Fund’s earnings. It is currently expected that distributions to common shareholders in 2021 will primarily constitute a return of capital for tax purposes.

Distribution Month

   

Record Date

   

Payable Date

January

   

January 14, 2021

   

January 22, 2021

February

   

February 11, 2021

   

February 19, 2021

March

   

March 17, 2021

   

March 24, 2021

The Board of Trustees will continue to monitor the Fund’s distribution level, taking into consideration the Fund’s net asset value and the financial market environment. The distribution rate should not be considered the dividend yield or total return on an investment in the Fund.

Because the Fund’s current monthly distributions are subject to modification by the Board of Trustees at any time and the Fund’s income will fluctuate, there can be no assurance that the Fund will pay distributions at a particular rate or frequency. Shareholders should not draw any conclusions about the Fund’s investment performance from the amount of the current distribution.

Contact John Ball ([email protected] or 914-921-7728) for tax information.

Investors should carefully consider the investment objectives, risks, charges, and expenses of the Fund before investing. More information regarding the Fund’s distribution policy and other information about the Fund is available by calling 800-GABELLI (800-422-3554) or visiting www.gabelli.com.

The Fund’s NAV per share will fluctuate with changes in the market value of the Fund’s portfolio securities. Stocks are subject to market, economic, and business risks that cause their prices to fluctuate. Investors acquire shares of the Fund on a securities exchange at market value, which fluctuates according to the dynamics of supply and demand. When Fund shares are sold, they may be worth more or less than their original cost. Consequently, you can lose money by investing in the Fund.

Covered Call and Other Option Transaction Risks. There are several risks associated with writing covered calls and entering into other types of option transactions. For example, there are significant differences between the securities and options markets that could result in an imperfect correlation between these markets, resulting in a given transaction not achieving its objectives. In addition, a decision as to whether, when, and how to use covered call options involves the exercise of skill and judgment, and even a well-conceived transaction may be unsuccessful because of market behavior or unexpected events. As the writer of a covered call option, the Fund forgoes, during the option’s life, the opportunity to profit from increases in the market value of the security covering the call option above the exercise price of the call option, but has retained the risk of loss should the price of the underlying security decline.

About The GAMCO Global Gold, Natural Resources & Income Trust

The GAMCO Global Gold, Natural Resources & Income Trust is a non-diversified, closed-end management investment company with $708 million in total net assets whose primary investment objective is to provide a high level of current income. The Fund invests primarily in equity securities of gold and natural resources companies and intends to earn income primarily through a strategy of writing (selling) primarily covered call options on equity securities in its portfolio. The Fund is managed by Gabelli Funds, LLC, a subsidiary of GAMCO Investors, Inc. (NYSE:GBL).

NYSE American – GGN

CUSIP – 36465A109

Investor Relations Contact:

Molly Marion

(914) 921-5681

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Banking Other Professional Services Professional Services Finance

MEDIA:

T-Mobile Kicks Off #CaptureKindness Campaign to Help Feeding America® Give 15 Million Meals and Take Back 2020 With a Magenta Wave of Positivity

T-Mobile Kicks Off #CaptureKindness Campaign to Help Feeding America® Give 15 Million Meals and Take Back 2020 With a Magenta Wave of Positivity

What’s the news: Starting on World Kindness Day (Nov. 13) through Giving Tuesday (Dec. 1) and ending on Dec. 4, 2020, T-Mobile is closing out this year by spreading the love and asking everyone to #CaptureKindness. Photos and stories posted on social media, along with customer clicks in the T-Mobile Tuesdays App on Giving Tuesday, will translate to the Un-carrier’s biggest contribution to Feeding America® ever — up to 15 million meals* delivered to families across the U.S.

Why it matters: Millions of Americans are facing food insecurity right now, particularly due to the devastating impact of the COVID-19 pandemic. T-Mobile wants to give back and do it while making others feel good — providing people a reason to smile and hopefully encouraging all of us to reconnect with our communities. Leave it up to the Supercharged Un-Carrier to help supercharge America’s kindness (with even more kindness!) through the #CaptureKindness campaign.

Who it’s for: Anyone who needs a little positivity in their life right now (and who doesn’t!?!).

BELLEVUE, Wash.–(BUSINESS WIRE)–
Love and connection are at the heart of who T-Mobile is, and this Giving Season it’s pretty clear we ALL need more of both! So, starting on World Kindness Day (Nov. 13) through Giving Tuesday (Dec. 1) and ending on Dec. 4, 2020, the Un-Carrier is inviting everyone to #CaptureKindness through social media posts and T-Mobile Tuesday clicks — and help Feeding America®, the country’s largest hunger-relief nonprofit, deliver millions of meals to people facing food insecurity.

As Feeding America® estimates up to 50 million families are impacted by the COVID-19 pandemic, there is a critical need this holiday season. So, T-Mobile is stepping up with its biggest donation goal to date to support Feeding America’s mission to end hunger — 15 million meals — and they’re asking customers, fans and employees to join them. Here’s how:

  • For every act of kindness shared on Twitter, Facebook and Instagram with the hashtag #CaptureKindness (Nov. 13, 2020 through Dec. 4, 2020), T-Mobile will donate $10 (equivalent to 100 meals) to Feeding America®, up to $1 million (or up to 10 million meals). From donations to charity, checking in with an elderly neighbor, or paying for a stranger’s coffee… every good deed counts!
  • On Giving Tuesday (Dec. 1, 2020), for each customer that clicks on the Feeding America® donation option in the T-Mobile Tuesdays app, the company will donate $1, up to $500,000. With each dollar equaling 10 meals to Feeding America®, this is ANOTHER opportunity to donate 5 million more meals!
  • To keep track of this big magenta wave of positivity, T-Mobile unveiled a special page that features a custom-built Kind-O-Meter that illustrates just how many people are sharing the love across the country!

“2020 has been filled with a lot unexpected challenges, important milestones and big moments — and through it all, T-Mobile has been there for our customers as a reliable and consistent lifeline to the world. Now we want to help end this year on a high note and spread some goodness and positivity — just what everyone needs! We love the idea of people coming together to #CaptureKindness, using their devices to share goodwill and love, and giving back to those in our communities who need it most right now,” said T-Mobile CEO Mike Sievert. “I can’t wait to see that Kind-0-Meter tick up and up every single day with photos, posts and likes!”

“After the year we’ve had, we could all use some extra compassion in our lives. And like T-Mobile is showing, we can also spread some love to those who need it most. Fifty million Americans facing food insecurity is a sharp increase from last year’s 34.5 million, so I want to say thank you to T-Mobile for helping us finish the year by bringing more meals — and kindness — to more hungry families across the country,” said Claire Babineaux-Fontenot, CEO of Feeding America.

But the goodness doesn’t stop there. Because T-Mobile employees are passionate about giving back to their communities, the T-Mobile Foundation is giving each employee $20 to contribute to a charity of their choice, AND matching employees’ personal donations 2:1 (up to $750,000, and up to $4,000 per employee) from Dec. 1 to Dec. 31, 2020.

Be sure to watch http://www.tmobilecapturekindness.com/ this holiday season!

About T-Mobile

T-Mobile U.S. Inc. (NASDAQ: TMUS) is America’s supercharged Un-carrier, delivering an advanced 4G LTE and transformative nationwide 5G network that will offer reliable connectivity for all. T-Mobile’s customers benefit from its unmatched combination of value and quality, unwavering obsession with offering them the best possible service experience and undisputable drive for disruption that creates competition and innovation in wireless and beyond. Based in Bellevue, Wash., T-Mobile provides services through its subsidiaries and operates its flagship brands, T-Mobile, Metro by T-Mobile and Sprint. For more information please visit: http://www.t-mobile.com.

*$1 helps provide at least 10 meals secured by Feeding America on behalf of local member food banks. Nov. 13, 2020 through Dec. 4, 2020: Minimum donation of $100,000.

T-Mobile US Media Relations

[email protected]

or

Investor Relations

[email protected]

KEYWORDS: Washington United States North America

INDUSTRY KEYWORDS: Philanthropy Consumer Electronics Technology Mobile/Wireless Telecommunications Fund Raising

MEDIA:

Logo
Logo

Todos Medical CEO Provides Corporate Update

NEW YORK, NY, REHOVAT, ISRAEL, SINGAPORE, Nov. 13, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Todos Medical (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening and diagnosis, and developing blood tests for the early detection of cancer and Alzheimer’s disease, today announced that President & CEO Gerald Commissiong has provided a corporate update to the shareholders:

Dear Shareholder,

We would like to thank you for continued support as we execute on the vision we laid out in the first half of 2020, transitioning the Company from a cancer and Alzheimer’s-focused R&D diagnostics company into a commercial organization focused on providing comprehensive solutions to address the United States’ biggest challenges in testing, tracing and immune support in response to the COVID-19 pandemic. Going forward as the newly created business lines mature, each at their own pace, we are seeking to adjust expectations in light of the market’s response to our progress and address some of the limiting factors to value creation.



Nasdaq Uplisting Timing

Given where the Company’s common stock is currently trading, we do not believe it is realistic to uplist to Nasdaq in 2020, but rather look to achieve that milestone in the first half of 2021. We are focused on creating value for our common shareholders and, given where our common stock is currently trading, we believe it is prudent to remove the risk of a significant reverse split from market concerns until we have demonstrated several more months of growing sales and commercial execution. Given that the Company is now generating revenue that we expect to continue to grow significantly into 2021, we now believe that our common equity can significantly increase in value on the OTC Markets™ because we believe we are well positioned as a growing commercial organization with the upside of several attractive research & development programs with patent protected development-stage programs addressing large market opportunities. While we are disappointed the market is not currently recognizing our fundamental value, we now have a significant opportunity to begin to educate the marketplace with regards to our overall business, and specifically our COVID-19 business.



COVID-19 Testing

Todos has positioned itself as a ‘one stop shop’ for all things COVID testing related. We understand that there is significant confusion with regards to COVID testing, and therefore we are outlining here exactly what we offer in the different types of testing products we make available to clients:


Polymerase Chain Reaction (PCR) Testing

PCR testing is now the gold-standard in COVID-19 testing. Definitive diagnoses are almost exclusively confirmed by PCR. As such, screening and surveillance testing of any kind will ultimately lead to a confirmatory PCR test.

Equipment to create workflows capable of conducting over 20,000 PCR tests per day per lab include:

1.     RNA automated extraction machines

2.     RT-PCR machines (96 well and 384 well)

3.     Liquid handler machines

4.     Automated and semi-automated pipettes

Reagents and consumables include:

1.     Extraction reagent kits

2.     COVID and COVID + influenza a/b qPCR reagent kits

3.     Swab and Viral Transport Medium kits

4.     Robotic and manual pipette tips

5.     PCR plates

6.     Validation Samples

Todos has optimized a workflow with Tecan liquid handlers currently being implemented at our Wisconsin client that will allow their lab to reach at least 20,000 diagnostic tests per day; and with pooling strategies being deployed for screening purposes, this client is expected to reach capacity to conduct over 100,000 tests per day. This client is currently at a capacity of 3,500 diagnostic tests per day with standard processes, and therefore we are confident in their ability to scale given this added automation. As they scale, we expect our sales to scale with them and we will be working very closely with them to overcome any barriers they have to meeting their full potential.  


Rapid Antigen Testing

Antigen testing allows for testing at lower accuracy rates than PCR, but with much faster turnaround times because the results are provided at the point of care. As such, it screens more people faster and take immediate action if a positive test leads to a suspected case of COVID-19 that needs to be confirmed by PCR. The Company has entered into several agreements with companies focused on bringing antigen tests into the marketplace. While our sales have been focused on PCR testing, we believe rapid antigen testing will become routine in the United States in the months ahead as new tests enter the marketplace and bring prices down to a level where tests can be deployed in virtually any setting. We have entered into one agreement in particular with a US-based manufacturer that expects to receive Emergency Use Authorization for their test in the near future, and we have significant plans to allow our sub-distribution network to aggressively market this test upon approval.


Rapid Antibody Testing

As schools, employers and other constituents begin to implement comprehensive COVID-19 surveillance programs, one of the key questions emerging is whether individuals have previously been infected with COVID-19. We have secured rights to the FDA Emergency Use Authorization (EUA) FaStep rapid SARS-CoV-2 antibody test and have added this to our offering to our sub-distribution partners.


Emerging COVID-19 Testing Technologies

The Company has also secured rights to several tests that are currently awaiting EUA approval from the FDA. These tests include point-of-care PCR tests that will compete with the Abbott ID Now™ and Cepheid point of care molecular tests. We also expect to enter into an agreement to secure distribution rights to lab-based tests to more comprehensively evaluate COVID-19 immune-status that we believe will become paramount as vaccines enter the marketplace and testing for immunity becomes more widespread in 2021.

Additionally, we are continuing to make significant progress with our 3CL protease rapid saliva/buccal test, being developed via our joint venture, COVID Antigen Test Killer LLC. We believe the 3CL tests we are developing will ultimately replace antigen testing because it adds important ‘active virus’ information to currently available PCR and antigen tests for COVID positive patients. We intend to first bring to market a lab-based test that will monitor PCR positive COVID-19 infected patients for active viral load, and thereafter a point of care test that can be used to replace antigen testing for screening and surveillance purposes. We will be releasing data from our ongoing studies in Israel in the coming weeks.


Mobile Labs

One of the most innovative programs Todos has been working on is the biosafety level 3 (BSL3) mobile labs solution that has been making steady progress and has now completed all of the instrument and clinical sample validation required to be able to receive CLIA certification for PCR testing. The mobile labs are now awaiting CLIA inspection in the days ahead, after an unexpected postponement of the inspection date occurred earlier this week. Upon receiving final certifications, several contracts are well into the negotiation phase and we expect revenues to begin to flow from this project in December. The mobile labs have the ability to conduct over 2,000 PCR tests per day, have been equipped with rapid antigen testing machines as well as lateral flow point of care antigen tests that will allow our implementation partners to conduct testing on large groups and confirm suspected COVID-19 cases by PCR, as well as do large scale PCR testing onsite with turnaround times of as little as 6 hours. We currently have 2 mobile labs in the final stages of authorization and have secured 10 additional mobile lab units that we will begin to build-out upon certification of the first unit. We expect to reach a production capacity of 100 mobile units per month in the first quarter of 2021.

We believe this initiative is innovative and timely because it addresses many of the key logistical challenges surrounding COVID-19 testing, and opens the possibility of also being used as the basis for added healthcare services around testing that will become increasingly important heading into 2021.



Tollovid™ – Immune Boosting Dietary Supplement

We believe the 3CL protease is an important drug development target for COVID-19 largely based on work Pfizer has published. Our joint venture with NLC Pharma has gained exclusive rights to bring to market the dietary supplement Tollovid, a 3CL protease inhibiting formulation of plant extracts designed to support and maintain healthy immune function. We believe Tollovid has a first-mover advantage in the 3CL protease inhibition space because it has received a Certificate of Free Sale by the FDA based largely on the data that has been generated by NLC in understanding how 3CL protease inhibition impacts the replication of coronaviruses generally. Our proprietary Tollovid formulation has been optimized to maximize 3CL protease inhibition using natural products, and we believe the current capsule formulation will become the basis of a line of products based on Tollovid’s active, 3CL protease-inhibiting ingredients. NLC recently completed certain experiments with Tollovid against actively circulating coronaviruses, and NLC expects to make that data available to the public in Israel in the weeks ahead.

Todos is now focused on the commercial launch of Tollovid at The Alchemist’s Kitchen™ in New York City, where it can gain immediate traction with wellness-minded consumers looking for plant-based solutions to support and maintain immune function at this time of heightened viral infection risk. We are also creating our own Todos brand for the Tollovid product and will make that available after we’ve received sufficient market information from the initial product launch at The Alchemist’s Kitchen. We believe the timing is ripe for Tollovid to become a very significant product in the dietary supplement space and are focused on securing key distribution channels to bring this important product to market.



Summary

The focus of the Company is now squarely focused on COVID-19 for the immediate term. We expect the revenues we generate from sales of COVID-19 testing solutions to drive the business in the near-term and position the Company to capitalize on the very significant programs we have in cancer and Alzheimer’s diagnostics. We are looking to ensure that we create value for our shareholders by executing on this plan and as such are taking a measured approach to our uplisting timelines because we believe the market is fundamentally not understanding the progress the Company has made to date.

We look forward to continuing to update you on our progress as we reach additional milestones and thank you for your continued support.

Gerald Commissiong

President & CEO

For information related to Todos Medical’s COVID-19 testing capabilities, please visit www.todoscovid19.com

For testing and PPE inquiries, please email [email protected].

About Tollovid™

Tollovid is an orally administered proprietary blend of plant extracts that includes a powerful 3CL protease inhibitor that helps support and maintain healthy immune function.

About The Alchemist’s Kitchen

The Alchemist’s Kitchen is a plant-based wellness brand dedicated to the education of consumers to the potential benefits of botanical medicines and herbal remedies. It develops and markets proprietary formulations via retail and online channels of distribution. The Alchemist’s Kitchen flagship storefront is located at 119 Crosby St, New York, NY 10003. The Company’s website is www.thealchemistskitchen.com.

About Todos Medical Ltd.

Headquartered in Rehovot, Israel, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company’s state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer’s influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos’ two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe. Todos recently entered into an exclusive option agreement to acquire U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab and Provista’s proprietary commercial-stage Videssa® breast cancer blood test. The transaction is expected to close in the third quarter of 2020.

Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer’s disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer’s disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.

Additionally, Todos has entered into distribution agreements with companies to distribute certain novel coronavirus (COVID-19) test kits. The agreements cover multiple international suppliers of PCR testing kits and related materials and supplies, as well as antibody testing kits from multiple manufacturers after completing validation of said testing kits and supplies in its partner CLIA/CAP certified laboratory in the United States. Todos has formed strategic partnerships with Integrated Health LLC, MOTOPARA Foundation to deploy mobile COVID-19 testing in the United States.

For more information, please visit https://www.todosmedical.com/.

Forward-looking Statements

Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.

Todos Investor Contact:

Kim Sutton Golodetz

LHA Investor Relations

Senior Vice President

(212) 838-3777

[email protected]

Todos Corporate Contact:

Priyanka Misra

Todos Medical

(917) 983-4229 ext. 103

[email protected]



Litchfield Hills Research Initiates Analyst Coverage of USA Equities Corp. (USAQ)

West Palm Beach, FL, Nov. 13, 2020 (GLOBE NEWSWIRE) — USA Equities Corp. (OTCQB: USAQ), and its wholly owned subsidiary Medical Practice Income, a company focused on value-based healthcare solutions and physician-directed digital medicine, is proud to announce today, equity research firm, Litchfield Hills Research LLC released its first analyst coverage report on USAQ, rating the Company a “Buy” under its three-tiered (buy-hold-sell) rating system, with a target price of $5.00 per share.

As of the end of its last trading day, USAQ’s shares closed at $.62 per share.

“We are pleased Litchfield Hills Research initiated research and analyst coverage of USAQ. Litchfield has shown a keen interest in our digital and virtual medicine technologies and will continue to cover our company in the future,” said Troy Grogan, CEO of USA Equities Corp.

Litchfield Hills Research adheres to FINRA standards for quality and objectivity. The Litchfield Hills Research Department certifies its report is compliant with FINRA research rules 2241, 3110. Litchfield’s price target, financial models, peer comparisons, and investment thesis are developed without input from management of the company, and they perform their own USAQ due diligence.

The research report is MiFID II compliant and is classified as minor non-monetary benefit under MiFID II. It is accessible on Bloomberg, FactSet, NASDAQ, NYSE Connect, S&P Cap IQ, Thomson Reuters (Refinitiv) and 12 other platforms around the globe. It will be posted to the research firm’s website http://www.hillsresearch.com/current-research/

About USA Equities Corp (OTCQB: USAQ)

On December 20, 2019 USA Equities Corp entered into and consummated a share exchange with the former stockholders of Medical Practice Income, Inc. (MPI), a Florida corporation. As a result of the Share Exchange, MPI became our wholly-owned-subsidiary. We are focused on value-based healthcare solutions, clinical informatics and algorithmic personalized medicine including digital therapeutics, behavior based remote patient monitoring, chronic care and preventive medicine. The Company’s intellectual properties, products and information service portfolio is directed towards prevention, early detection, management, and reversal of cardio-metabolic and other chronic diseases. Our principle objectives are to develop proprietary software tools, devices, and approaches, providing more granular, timely, and specific clinical decision-making information for practicing physicians and other health care providers to address todays obese, diabetic and cardiovascular disease population and is located in West Palm Beach, Florida. For more information, visit www.MedicalPracticeIncome.com/discover.

Forward-Looking Statements

This press release contains forward-looking statements which are identified by words such as ‘may’, ‘could’, ‘believes’, ‘estimates’, ‘targets’, ‘expects’, or ‘intends’ and other similar words that involve risks and uncertainties. These statements have not been based solely on historical facts but on USA Equities Corp current expectations about future events and results. You should consider that as such statements relate to future matters, they are subject to various inherent risks, uncertainties and assumptions that could cause actual results or events to differ materially from expectations described in the forward-looking statement. Various important factors could cause actual results or events to differ materially from the forward-looking statements that USA Equities Corp makes, including, but not limited to, the risk that software development and studies may be delayed and may not have satisfactory outcomes, the risk that costs required to continue our Software as a Service (SaaS) or to expand our operations will be higher than anticipated and other risks described in the “Risk Factors” section of our Annual Report on Form 10-K filed by USA Equities Corp with the SEC on February 21, 2020. Except where required by law, USA Equities Corp. has no intention to update or revise forward looking statements, or to publish prospective financial information in the future, regardless of whether new information, future events or any other factors affect the information contained in this presentation. None of USA Equities Corp Directors, Consultants, or any other person named with their consent in this presentation can assure you that any forward-looking statement or result expressed or implied by any forward-looking statement will be achieved.

Investor Relations Contact:
Keith Pinder
Landon Capital
(404) 995-6671

[email protected]

Firsthand Technology Value Fund Announces Third Quarter Financial Results, NAV of $13.81 per share

SAN JOSE, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) — Firsthand Technology Value Fund, Inc. (NASDAQ: SVVC) (the “Fund”), a publicly traded venture capital fund that invests in technology and cleantech companies, announced today its financial results for the third quarter ended September 30, 2020.

As of September 30, 2020, the Fund’s net assets were approximately $95.2 million, or $13.81 per share, compared with net assets of approximately $101.3 million, or $14.70 per share as of June 30, 2020. As September 30, 2020, the Fund’s portfolio included public and private securities valued at approximately $93.2 million, or $13.52 per share, and approximately $0.34 per share in cash and cash equivalents.

Portfolio Summary (as of 9/30/20)

Investment Fair Value

1,
  Fair Value

per Share

1,2
Equity/Debt Investments $93.17 million   $13.52
Cash/Cash Equivalents $2.32 million   $0.34
Other Assets $4.97 million   $0.72
Total Assets $100.46 million   $14.57
Total Liabilities $5.25 million   $0.76
Net Assets $95.21 million   $
13.81
1 Numbers may not sum due to rounding.
2 Total shares outstanding: 6,893,056.

During the third quarter of 2020, the Valuation Committee, which was composed of four independent directors, adjusted the fair values of the private companies in our portfolio. In arriving at these determinations and consistent with the Fund’s valuation procedures, and ASC 820, the Valuation Committee took into account many factors, including the performance of the portfolio companies, recent transactions in the companies’ securities, as well as the impact of changes in market multiples within certain sectors.

For the three months ended September 30, 2020, the Fund reported investment income of approximately $1.1 million. The Fund reported net investment income, net of deferred taxes, of approximately $262 thousand. The Fund reported net realized and unrealized losses on investments, net of deferred taxes, of approximately $6.4 million for the quarter.

Throughout the quarter, the Fund continued its efforts to manage its portfolio prudently, including working with its portfolio companies and their management teams to seek to enhance performance and uncover potential exit opportunities.

About Firsthand Technology Value Fund

Firsthand Technology Value Fund, Inc. is a publicly traded venture capital fund that invests in technology and cleantech companies. More information about the Fund and its holdings can be found online at www.firsthandtvf.com.

The Fund is a non-diversified, closed-end investment company that elected to be treated as a business development company under the Investment Company Act of 1940. The Fund’s investment objective is to seek long-term growth of capital. Under normal circumstances, the Fund will invest at least 80% of its total assets for investment purposes in technology and cleantech companies. An investment in the Fund involves substantial risks, some of which are highlighted below. Please see the Fund’s public filings for more information about fees, expenses and risk. Past investment results do not provide any assurances about future results.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS: This press release contains “forward-looking statements” as defined under the U.S. federal securities laws. Generally, the words “believe,” “expect,” “intend,” “estimate,” “anticipate,” “project,” “will,” and similar expressions identify forward-looking statements, which generally are not historical in nature. Forward-looking statements are subject to certain risks and uncertainties that could cause actual results to materially differ from the Fund’s historical experience and its present expectations or projections indicated in any forward-looking statement. These risks include, but are not limited to, changes in economic and political conditions, regulatory and legal changes, technology and cleantech industry risk, valuation risk, non-diversification risk, interest rate risk, tax risk, and other risks discussed in the Fund’s filings with the SEC. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Fund undertakes no obligation to publicly update or revise any forward-looking statements made herein. There is no assurance that the Fund’s investment objectives will be attained. We acknowledge that, notwithstanding the foregoing, the safe harbor for forward-looking statements under the Private Securities Litigation Reform Act of 1995 does not apply to investment companies such as us.

Contact:

Phil Mosakowski
Firsthand Capital Management, Inc.
(408) 624-9526
[email protected]

Ziopharm Oncology to Participate in Jefferies Virtual London Healthcare Conference on November 19, 2020

BOSTON, Nov. 13, 2020 (GLOBE NEWSWIRE) — Ziopharm Oncology, Inc. (Nasdaq: ZIOP), today announced that Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm, is scheduled to participate in a fireside chat at the Jefferies Virtual London Healthcare Conference on November 19, 2020 at 1:45 pm ET.

To access the live webcast presentation, or the subsequent archived recording, please visit the “Investors” section of the Ziopharm website at www.ziopharm.com.

About Ziopharm Oncology, Inc.
Ziopharm is developing non-viral and cytokine-driven cell and gene therapies that weaponize the body’s immune system to treat the millions of people globally diagnosed with a solid tumor each year. With its multiplatform approach, Ziopharm is at the forefront of immuno-oncology with a goal to treat any type of solid tumor. Ziopharm’s pipeline is built for commercially scalable, cost effective T-cell receptor T-cell therapies based on its non-viral Sleeping Beauty gene transfer platform, a precisely controlled IL-12 gene therapy, and rapidly manufactured Sleeping Beauty-enabled CD19-specific CAR-T program. The Company has clinical and strategic partnerships with the National Cancer Institute, The University of Texas MD Anderson Cancer Center and others. For more information, please visit www.ziopharm.com

Investor Relations Contacts:
Ziopharm Oncology:
Chris Taylor
VP, Investor Relations and Corporate Communications
T: 617.502.1881
E: [email protected]

LifeSci Advisors:
Mike Moyer
Managing Director
T: 617.308.4306
E: [email protected]

Media Relations Contact:

LifeSci Communications:
Patrick Bursey
T: 646.876.4932
E: [email protected]



Gabelli Global Utility & Income Trust Continues Monthly Distributions, Declaring Distributions of $0.10 Per Share

Gabelli Global Utility & Income Trust Continues Monthly Distributions, Declaring Distributions of $0.10 Per Share

RYE, N.Y.–(BUSINESS WIRE)–
The Board of Trustees of The Gabelli Global Utility & Income Trust (NYSE American: GLU) (the “Fund”) approved the continuation of its policy of paying fixed monthly cash distributions. The Board of Trustees declared cash distributions of $0.10 per share for each of January, February, and March 2021.

Distribution Month

Record Date

Payable Date

January

January 14, 2021

January 22, 2021

February

February 11, 2021

February 19, 2021

March

March 17, 2021

March 24, 2021

Under the Fund’s initial distribution policy, the Fund has paid a minimum annual distribution of 6% of the initial public offering price of $20.00 per share (a distribution of $0.10 per share each month).

Each quarter, the Board of Trustees reviews the amount of any potential distribution from the income, realized capital gain, or capital available. The Board of Trustees will continue to monitor the Fund’s distribution level, taking into consideration the Fund’s net asset value and the financial market environment. If necessary, the Fund will pay an adjusting distribution in December which includes any additional income and net realized capital gains in excess of the monthly distributions for that year to satisfy the minimum distribution requirements of the Internal Revenue Code for regulated investment companies. The Fund’s distribution policy is subject to modification by the Board of Trustees at any time, and there can be no guarantee that the policy will continue. The distribution rate should not be considered the dividend yield or total return on an investment in the Fund.

All or part of the distribution may be treated as long-term capital gain or qualified dividend income (or a combination of both) for individuals, each subject to the maximum federal income tax rate for long term capital gains, which is currently 20% in taxable accounts for individuals (or less depending on an individual’s tax bracket). In addition, certain U.S. shareholders who are individuals, estates or trusts and whose income exceeds certain thresholds will be required to pay a 3.8% Medicare surcharge on their “net investment income”, which includes dividends received from the Fund and capital gains from the sale or other disposition of shares of the Fund.

If the Fund does not generate sufficient earnings (dividends and interest income, less expenses, and realized net capital gain) equal to or in excess of the aggregate distributions paid by the Fund in a given year, then the amount distributed in excess of the Fund’s earnings would be deemed a return of capital. Since this would be considered a return of a portion of a shareholder’s original investment, it is generally not taxable and would be treated as a reduction in the shareholder’s cost basis.

Long-term capital gains, qualified dividend income, investment company taxable income, and return of capital, if any, will be allocated on a pro-rata basis to all distributions to common shareholders for the year. Based on the accounting records of the Fund currently available, each of the distributions paid to common shareholders in 2020 would be deemed 100% from paid-in capital on a book basis. The source of the distributions will likely change due to investment activity through the end of the calendar year and this information does not represent what should be reported for tax purposes. The estimated components of each distribution are updated and provided to shareholders of record in a notice accompanying the distribution and are available on our website (www.gabelli.com). The final determination of the sources of all distributions in 2020 will be made after year end and can vary from the monthly estimates. Shareholders should not draw any conclusions about the Fund’s investment performance from the amount of the current distribution. All individual shareholders with taxable accounts will receive written notification regarding the components and tax treatment for all 2020 distributions in early 2021 via Form 1099-DIV.

Investors should carefully consider the investment objectives, risks, charges, and expenses of the Fund before investing. More information regarding the Fund’s distribution policy and other information about the Fund is available by calling 800-GABELLI (800-422-3554) or visiting www.gabelli.com.

About The Gabelli Global Utility & Income Trust

The Gabelli Global Utility & Income Trust is a non-diversified, closed-end management investment company with $163 million in total net assets whose primary investment objective is to seek a consistent level of after-tax total return for its investors with an emphasis on tax-advantaged dividend income under current tax law. The Fund is managed by Gabelli Funds, LLC, a subsidiary of GAMCO Investors, Inc. (NYSE:GBL).

NYSE American – GLU

CUSIP – 36242L105

Investor Relations Contact:

Adam Tokar

(914) 457-1079

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Banking Professional Services Finance

MEDIA:

NEXLETOL® (bempedoic acid) Tablets Highlighted at AHA 2020 with Presentations of Analyses Demonstrating Significant Low-Density Lipoprotein Cholesterol (LDL-C) Lowering vs. Placebo in Phase 3 Study Subgroups

– Significant mean reduction of 26.5% in LDL-C with
bempedoic
acid
vs. placebo
in pooled analysis of people who cannot tolerate statins

1


– Analysis by
sex
showed
bempedoic
acid significantly lowered LDL-C at week 12 in
males and females
* vs. placebo

2

ANN ARBOR, Mich., Nov. 13, 2020 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today announced results of pooled data from four of the company’s Phase 3 trials were presented at the virtual American Heart Association Scientific Sessions 2020 (AHA 2020). Both analyses demonstrated significant lowering of low-density lipoprotein cholesterol (LDL-C) by NEXLETOL® (bempedoic acid) Tablets by week 12 in specific subgroups, including people who cannot tolerate statins and females, compared to placebo.     

“Women are half of the population, and nearly 10 million patients in the U.S. with high LDL-C levels are not on statins due to tolerability issues,3 yet these groups have been underrepresented in previous medical research,4” said Ashley Hall, Chief Development Officer for Esperion. “Our goal at Esperion is lipid management for everybody, and these analyses show significant LDL-C efficacy and acceptable safety for NEXLETOL in these subgroups.”

In “Efficacy and Safety of Bempedoic Acid in Patients Who Cannot Tolerate Any Dose of a Statin: Pooled Analysis from Phase 3 Clinical Trials,” (Abstract #P2139) data from a subgroup of more than 580 patients not receiving any dose of a statin showed a significant mean reduction of 26.5% (p< 0.001) in LDL-C by week 12 with NEXLETOL vs. placebo. NEXLETOL was generally well tolerated, with treatment-emergent adverse events (TEAEs) comparable across the bempedoic acid and placebo groups.1

The poster “Efficacy and Safety of Bempedoic Acid by Sex: Pooled Analyses From Phase 3 Trials” (Abstract #P742) showed NEXLETOL significantly lowered LDL-C at week 12 in both sexes compared with placebo for a pooled population of more than 3,600 patients across four studies. LDL-C lowering was numerically greater in females compared with males across both pools of the study: The placebo-corrected mean reduction was 27.7% for females vs. 22.1% for males (interaction p value=0.079) in the statin-intolerant pool, and 21.2% for females vs. 17.4% for males (interaction p value=0.044) in the pool of patients with atherosclerotic cardiovascular disease (ASVCD) and/or heterozygous familial hypercholesterolemia (HeFH) who were receiving background maximally tolerated statin. Bempedoic acid was generally well tolerated by both sexes.2

Approved earlier this year by the U.S. Food and Drug Administration (FDA) and launched at the height of the COVID-19 pandemic, NEXLETOL is the first oral, once-daily, non-statin LDL-C-lowering medicine available to indicated patients in nearly 20 years. The approval of NEXLETOL was supported by a global pivotal Phase 3 LDL-C-lowering program conducted in more than 3,000 patients with ASCVD and/or HeFH. In these studies, NEXLETOL provided an average of 18% placebo-corrected LDL-C lowering when used with moderate or high-intensity statins. The most common (incidence ≥ 2% and greater than placebo) adverse reactions were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes. NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular morbidity and mortality has not yet been determined. Please see important safety information below.

*Note: Esperion strives to be inclusive in our both research and our language, and we follow the language guidance outlined in “Reporting Sex, Gender, or Both in Clinical Research?” from The Journal of the American Medicine Association (JAMA).

NEXLETOL® (bempedoic acid) Tablet

NEXLETOL is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptors. NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine approved in the U.S. in nearly 20 years for patients with ASCVD or HeFH. NEXLETOL was approved by the FDA in February 2020.

Indication and Limitation of Use

NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

Important Safety Information

  • Warnings and Precautions:
    • Elevations in serum uric acid have occurred. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. The risk for gout events with NEXLETOL® (bempedoic acid) tablet was higher in patients with a prior history of gout although gout also occurred more frequently than placebo in patients treated with NEXLETOL™ (bempedoic acid) tablet who had no prior gout history.
    • Tendon rupture has occurred. Discontinue NEXLETOL® (bempedoic acid) tablet at the first sign of tendon rupture. Avoid NEXLETOL® (bempedoic acid) tablet in patients who have a history of tendon disorders or tendon rupture.
  • Adverse Reactions:
  • Drug Interactions:
    • Avoid concomitant use of NEXLETOL with simvastatin greater than 20 mg.
    • Avoid concomitant use of NEXLETOL with pravastatin greater than 40 mg.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Esperion at 833-377-7633 (833 ESPRMED).


Please see the full Prescribing Information for NEXLETOL by clicking here.

Esperion Therapeutics

Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding commercialization plans for bempedoic acid tablet. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, delays or failures in Esperion’s clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, the impact of COVID-19 on our business, clinical activities and commercial development plans, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

References

1 Laufs U, et al. Efficacy and Safety of Bempedoic Acid in Patients who Cannot Tolerate Any Does of a Statin: Pooled Analysis from Phase 3 Clinical Trials. Presentation at the American Heart Association Virtual Scientific Sessions 2020. November 2020.

2 Goldberg AC, et al. Efficacy and Safety of Bempedoic Acid by Sex: Pooled Analyses From Phase 3 Trials. Presentation at the American Heart Association Virtual Scientific Sessions 2020. November 2020.

3 ZS Associates primary and secondary research, Sep-Oct 2018. Primary research N = 350 healthcare practitioners

4 J Tamargo, G Rosano, T Walther, J Duarte, A Niessner, JC Kaski, C Ceconi, H Drexel, K Kjeldsen, G Savarese, C Torp-Pedersen, D Atar, BS Lewis, S Agewall, Gender differences in the effects of cardiovascular drugs, European Heart Journal – Cardiovascular Pharmacotherapy, Volume 3, Issue 3, July 2017, Pages 163–182, https://doi.org/10.1093/ehjcvp/pvw042

Contact:
Kaitlyn Brosco
Esperion
[email protected]