ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment in China

PR Newswire

SHANGHAI and SAN FRANCISCO, Nov. 18, 2020 /PRNewswire/ — Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) and Sagimet Biosciences Inc. jointly announced today that they have completed patient enrollment in the ASC40 (TVB-2640) Phase 2 NASH trial in China. The trial in China with 30 patients enrolled is part of the global Phase 2 clinical program.

On June 17, Sagimet Biosciences Inc., announced positive results on oral, once-daily dosing of NASH drug candidate ASC40 (TVB-2640) from its Phase 2 (FASCINATE-1) clinical trial in the United States. The preliminary data showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. Participants also showed improvement in markers of liver function and fibrosis. In this randomized, placebo-controlled trial of 99 patients in the United States, clinicians evaluated the safety and efficacy of ASC40 (TVB-2640) for 12 weeks. ASC40 (TVB-2640) was well-tolerated with a benign adverse event profile, predominantly grade 1 adverse events and no on-treatment serious adverse events.

“This is the first Phase 2 NASH trial that has completed patient enrollment in mainland China, which enables the completion of 12 week treatment of all patients in February 2021,” said Dr. Junping Shi, Deputy Dean of the Affiliated Hospital of Hangzhou Normal University, Deputy Leader of the Fatty Liver and Alcoholic Hepatology Group of the Chinese Medical Association Hepatology Branch, principal investigator of ASC40 (TVB-2640) Phase 2 trial in China. “We are excited by results from the Phase 2 NASH trial in the United States. Based upon the data from the bridging study in China, I believe the efficacy of ASC40 (TVB-2640) in Chinese patients will be similarly potent.”

“Additional data from U.S. patients were recently presented by Dr. Rohit Loomba at The Liver Meeting of American Association for the Study of Liver Diseases (AASLD) that confirm the potential benefit of TVB-2640 to NASH patients. We are excited to move forward with our planned Phase 2b biopsy trial, as well as work with our partner Gannex to understand better dosing of TVB-2640 in Chinese patients,” said George Kemble, CEO of Sagimet.

“We are pleased that we completed the patient enrollment ahead of the schedule and want to thank all patients and doctors. I look forward to the completion of this Phase 2 NASH trial in China,” said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.

About TVB-2640

TVB-2640 is an orally bioavailable, first-in-class FASN inhibitor. FASN is a key enzyme in the de novo lipogenesis (DNL) pathway that is responsible for the synthesis of excess fat and activation of fibrogenic and inflammatory mechanisms in the liver of patients with NASH. Sagimet’s approach targets these key drivers of NASH. The company announced in June 2020 initial results of a randomized, placebo-controlled Phase 2 trial, FASCINATE-1, which evaluated the impact of TVB-2640 in 99 NASH patients in the United States. Sagimet and its partner, Gannex Pharma Co., Ltd., have completed the enrollment of 30 NASH patients in China. Based upon the strength of this Phase 2 imaging and biomarker data, Sagimet expects to initiate a Phase 2b biopsy trial in 1H 2021. The company has demonstrated in preclinical models that blocking FASN not only reduces liver fat, but directly reduces fibrosis and inflammation– addressing three major drivers of NASH.

About Sagimet

Sagimet Biosciences is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to treat important diseases such as the liver disease NASH and specific cancers, with focus on targeting dysfunctional metabolic pathways. The company has unique expertise in FASN biology and has created a pipeline of proprietary FASN inhibitors. For more information, please visit www.sagimet.com.

About Ascletis

Ascletis is an innovative R&D driven biotech and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis is committed to developing and commercializing innovative drugs of viral hepatitis, NASH and HIV/AIDS, for unmet medical needs in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis has three marketed products and thirteen R&D pipeline drug candidates or combination therapies (nine of them developed in house). 1. Viral hepatitis: (i) marketed all oral HCV regimen of Asclevir® and Ganovo® combination (RDV/DNV regimen) and ASC18 fixed dose combination (FDC), with bridging study finished, is an upgraded version of RDV/DNV regimen. ASC18FDC will further enhance the competitiveness of Ascletis ‘ hepatitis C products. (ii) marketed Pegasys® for HBV clinical cure; (iii) breakthrough therapies for HBV clinical cure. 2. NASH: global development of novel drug candidates against three different targets – FASN, THR-beta and FXR, and three combination therapies. NASH is a global disease, Ascletis conducts global clinical research in Europe, America and China. 3. HIV/AIDS: ASC09F is a FDC treatment of HIV targeting protease. The clinical trial application of ASC09F has been approved. For more information, please visit www.ascletis.com.

Cision View original content:http://www.prnewswire.com/news-releases/asc40-tvb-2640-phase-2-nash-trial-completed-patient-enrollment-in-china-301176538.html

SOURCE Ascletis Pharma Inc.

SHAREHOLDER ALERT: WeissLaw LLP Reminds PE, GHIV, CCX, and ACAM Shareholders About Its Ongoing Investigations

PR Newswire

NEW YORK, Nov. 18, 2020 /PRNewswire/ —


If you own shares in any of the companies listed above and would like to discuss our investigations or have any questions concerning this notice or your rights or interests, please contact:


Joshua Rubin, Esq.

WeissLaw LLP
1500 Broadway, 16th Floor
New York, NY  10036
(212) 682-3025
(888) 593-4771
[email protected]

Parsley Energy, Inc. (NYSE: PE)
 

WeissLaw LLP is investigating possible breaches of fiduciary duty and other violations of law by the board of directors of Parsley Energy, Inc. (NYSE: PE) in connection with the proposed acquisition of the company by Pioneer Natural Resources Company (“Pioneer”).  Under the terms of the agreement, PE stockholders will receive 0.1252 shares of Pioneer common stock for each share of PE common stock that they own, representing implied per-share merger consideration of $12.01 based upon Pioneer’s November 17, 2020 closing price of $95.91.  If you own PE shares and wish to discuss this investigation or your rights, please call us at one of the numbers listed above or visit our website:   https://weisslawllp.com/pe/

Gores Holdings IV, Inc. (NASDAQ: GHIV)

WeissLaw LLP is investigating possible breaches of fiduciary duty and other violations of law by the board of directors of Gores Holdings IV, Inc. (NASDAQ: GHIV) in connection with the company’s proposed merger with United Wholesale Mortgage (“United Wholesale”).  Under the terms of the agreement, GHIV will acquire United Wholesale through a reverse merger that will result in United Wholesale becoming a publicly-listed company.  If you own GHIV shares and wish to discuss this investigation or your rights, please call us at one of the numbers listed above or visit our website: https://weisslawllp.com/ghiv/

Churchill Capital Corp II (NYSE: CCX)

WeissLaw LLP is investigating possible breaches of fiduciary duty and other violations of law by the board of directors of Churchill Capital Corp II (NYSE: CCX) in connection with the company’s proposed merger with Software Luxembourg Holding S.A. (“Skillsoft”).  Under the terms of the agreement, CCX will acquire Skillsoft through a reverse merger that will result in Skillsoft becoming a publicly-traded company.  If you own CCX shares and wish to discuss this investigation or your rights, please call us at one of the numbers listed above or visit our website: https://weisslawllp.com/ccx/   

Acamar Partners Acquisition Corp. (NASDAQ: ACAM)

WeissLaw LLP is investigating possible breaches of fiduciary duty and other violations of law by the board of directors of Acamar Partners Acquisition Corp. (NASDAQ: ACAM) in connection with the company’s proposed merger with CarLotz, Inc. (“CarLotz”).  Under the terms of the agreement, ACAM will acquire CarLotz through a reverse merger that will result in CarLotz becoming a public company.  If you own ACAM shares and wish to discuss this investigation or your rights, please call us at one of the numbers listed above or visit our website: https://www.weisslawllp.com/acam/   

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/shareholder-alert-weisslaw-llp-reminds-pe-ghiv-ccx-and-acam-shareholders-about-its-ongoing-investigations-301176549.html

SOURCE WeissLaw LLP

Bally’s Corporation To Acquire Premier U.S. Regulated Sportsbook Technology Platform Bet.Works

Proprietary Technology Stack Key Step In Bally’s Transformation To Become Premier Vertically Integrated Omni-Channel U.S. Gaming Provider

Acquisition Enables Significant Expansion of Sports Betting and iGaming Initiatives

PR Newswire

PROVIDENCE, R.I., Nov. 18, 2020 /PRNewswire/ — Bally’s Corporation (NYSE: BALY) today announced that it has entered into a definitive agreement to acquire Bet.Works, a U.S. based, sports betting platform provider to operators in New Jersey, Iowa, Indiana and Colorado, for $125 million, subject to adjustment. Upon acquiring Bet.Works’ proprietary technology stack and turnkey solutions, which include marketing, operations, customer service, risk management and compliance, Bally’s will become the premier, full-service, vertically integrated sports betting and iGaming company in the U.S. with physical casinos and online gaming solutions united under a single, preeminent brand, thus enabling it to launch its B2B2C business model.

Half of the Bet.Works purchase price will be paid in Bally’s common stock, which Bet.Works shareholders have agreed to hold for at least a year.

The Bet.Works acquisition represents the latest step in Bally’s long-term growth, development and unification strategy. Over the past two years, Bally’s has engaged in strategic and opportunistic expansion of its gaming and entertainment properties, which will include 14 casinos across 10 states once all pending transactions are completed. In addition, Bally’s recently acquired its iconic brand, which is synonymous with U.S. gaming and entertainment, and commensurate with the premier properties and amenities that define the Company’s portfolio.

The Bet.Works acquisition, which complements these initiatives, will provide Bally’s with a suite of advanced omni-channel products, platforms, software and content solutions that will enable it to deliver unrivaled sports betting and iGaming offerings to customers on a national scale. According to investment research by major Wall Street analysts and management estimates, the U.S. sports betting and iGaming market is expected to grow to $12 billion by 2025 and reach $50 billion at maturity. Bally’s estimates that the U.S. sports betting and iGaming market will reach $2.6 billion this year.

“This is the next step in our Company’s evolution,” said Soo Kim, Chairman of Bally’s Corporation’s Board of Directors. “By combining our expanding national footprint of casinos, the recently acquired Bally’s brand, and Bet.Works’ proprietary technology stack, we have evolved in just a few short years from a regional casino operator into the first U.S. gaming company committed to serving our customers with an omni-channel approach, combining the best of our physical properties with a superior online experience.”

Following the acquisition, Bally’s will form two distinct operating divisions: “Bally’s Casinos,” which will be comprised of Bally’s physical gaming and entertainment properties, and “Bally’s Interactive,” which will include new and existing contracts for sports betting and iGaming, including all of Bet.Works’ sports betting operations.

George Papanier, President and Chief Executive Officer of Bally’s Corporation, commented, “We are very excited to welcome Bet.Works to the Bally’s family. Owning Bet.Works’ superior technology platform will not only give Bally’s a long-term margin advantage online, but, more importantly, will also allow us to evolve our interactive product suite to go where sports betting and iGaming customers are headed quickly. David Wang and his team at Bet.Works have already demonstrated impressive growth and the ability to execute while creating a differentiated platform. We are very pleased to bring this technology to our more than 14 million active customers who will experience Bally’s Casinos and Bally’s Interactive as a unified brand with a single player card and rewards system.”

David Wang, Founder and CEO of Bet.Works, will serve as the CEO of Bally’s Interactive upon closing the transaction. Bally’s Interactive will integrate Bet.Works’ experienced team of over 130 employees across three offices, including approximately 90 engineers, into its interactive operations. Bally’s Interactive also plans to open a technology development center in Rhode Island by the end of 2021, initially with 25 employees.

Wang stated, “We are pleased to be joining the Bally’s family, which has demonstrated a remarkable track record of growth and diversification with a proven management team. We remain committed to creating the world’s best sports entertainment products, as well as delivering innovative and exciting solutions for sports betting and iGaming consumers across Bally’s national footprint. Bet.Works will continue to offer our best in class solutions to our existing B2B clients and our future partners in the U.S. market as we expand our reach into newly regulated states. Our turnkey solutions, which include Marketing, Operations, Customer Service, Risk Management and Compliance, combined with our dedicated launch teams, will ensure we maintain a leading position in the B2B sector while powering Bally’s Interactive. Bally’s is the perfect home for Bet.Works as it will allow us to continue to grow and innovate.”

Bally’s expects to close the transaction during the first quarter of 2021, pending regulatory approval and other customary closing conditions.

Bally’s will host a conference call tomorrow at 8:30a.m. EDT to discuss the partnership. David Wang will participate in the conference call.

To access the conference call, please dial (833) 570-1160 (U.S. toll-free) and reference conference ID 3282004. A webcast of the conference call will be available via the Investors section of the Company’s website www.ballys.com. An online archive of the webcast will be available for 120 days.

Advisor

Jones Day represented Bally’s on the transaction. Brownstein Hyatt Farber Schreck LLP represented Bet.Works on the transaction.

About Bally’s Corporation

Bally’s Corporation currently owns and operates 10 casinos across six states, a horse racetrack, and 13 authorized OTB licenses in Colorado. With more than 5,400 employees, the Company’s operations include 11,859 slot machines, 405 game tables and 2,538 hotel rooms. Properties include Twin River Casino Hotel (Lincoln, RI), Tiverton Casino Hotel (Tiverton, RI), Hard Rock Hotel & Casino (Biloxi, MS), Casino Vicksburg (Vicksburg, MS), Dover Downs Hotel & Casino (Dover, DE), Bally’s Atlantic City (Atlantic City, NJ), Casino KC (Kansas City, MO), Golden Gates Casino (Black Hawk, CO), Golden Gulch Casino (Black Hawk, CO), Mardi Gras Casino (Black Hawk, CO), and Arapahoe Park racetrack (Aurora, CO). Following the completion of pending acquisitions, which include Tropicana Evansville (Evansville, IN), Jumer’s Casino & Hotel (Rock Island, IL), Eldorado Shreveport Resort and Casino (Shreveport, LA), and MontBleu Resort Casino & Spa (Lake Tahoe, NV), the Company will own and operate 14 casinos across 10 states. Its shares trade on the New York Stock Exchange under the ticker symbol “BALY.”

About Bet.Works

Bet.Works is a U.S.-based technology and services company delivering the most advanced iGaming and sportsbook products. Its flexible suite of proprietary solutions, coupled with a sophisticated managed service offering, uniquely position Bet.Works to provide US-ready solutions to enterprise, tribal and regional clients. Bet.Works is the only company to have concurrently been granted GLI 19 & 33 certifications. For more information, please visit www.bet.works.

Forward Looking Statements

This communication contains “forward-looking” statements as that term is defined in the federal securities laws. All statements, other than historical facts, including future financial and operating results and Bally’s plans, objectives, expectations and intentions, legal, economic and regulatory conditions are forward-looking statements.

Forward-looking statements are sometimes identified by words like “may,” “will,” “should,” “potential,” “intend,” “expect,” “endeavor,” “seek,” “anticipate,” “estimate,” “overestimate,” “underestimate,” “believe,” “could,” “project,” “predict,” “continue,” “target” or other similar words or expressions. Forward-looking statements are based upon current plans, estimates and expectations that are subject to risks, uncertainties and assumptions. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by such forward-looking statements. The inclusion of such statements should not be regarded as a representation that such plans, estimates or expectations will be achieved. Important factors that could cause actual results to differ materially from such plans, estimates or expectations include, (1) that one or more closing conditions to Bally’s proposed transactions, including regulatory approvals, may not be satisfied or waived, on a timely basis or otherwise, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the proposed transactions or may require conditions, limitations or restrictions in connection with such approvals; (2) the risk that the proposed transactions may not be completed on the terms or in the time frame expected, or at all; (3) the risks that U.S. sports betting and iGaming will not increase as expected by management, unexpected costs, charges or expenses resulting from the proposed transactions, and risks involved in integrating a technology-focused company into Bally’s; (4) the occurrence of any event that could give rise to the termination of the proposed transactions; (5) risks related to acquisitions and the integration of the businesses and assets acquired; (6) the financial performance of  the acquired businesses; (7) potential adverse reactions or changes to business or employee relationships, including those resulting from the completion of the proposed transactions; (8) the possibility that the anticipated operating results and other benefits of the proposed transactions are not realized when expected or at all; (9) local risks including proximate competition, potential competition, legislative risks and local relationships; (10) uncertainty surrounding the ongoing COVID-19 outbreak; and (11) other risk factors as detailed under Part I. Item 1A. “Risk Factors” of Bally’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019 as filed with the Securities and Exchange Commission (“SEC”) on March 13, 2020 and Bally’s subsequent Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020 and September 30, 2020 as filed with the “SEC” on May 14, 2020, August 13, 2020 and November 6, 2020, respectively. The foregoing list of important factors is not exclusive. Any forward-looking statements speak only as of the date of this communication. Bally’s does not undertake any obligation to update any forward-looking statements, whether as a result of new information or development, future events or otherwise, except as required by law. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Investor Contact

Steve Capp

Executive Vice President and Chief Financial Officer 401-475-8564
[email protected]

Media Contacts

Richard Goldman / David Gill
Kekst CNC
646-847-6102 / 917-842-5384
[email protected]

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ballys-corporation-to-acquire-premier-us-regulated-sportsbook-technology-platform-betworks-301176566.html

SOURCE Bally’s Corporation

SHAREHOLDER ALERT: WeissLaw LLP Investigates CIIG Merger Corp.

PR Newswire

NEW YORK, Nov. 18, 2020 /PRNewswire/ — WeissLaw LLP is investigating possible breaches of fiduciary duty and other violations of law by the board of directors of CIIG Merger Corp. (“CIIG” or the “Company”) (NASDAQ: CIIC) in connection with the Company’s proposed merger with Arrival S.à r.l. (“Arrival”), a privately-held electric vehicle company.  Under the terms of the merger agreement, CIIG will acquire Arrival through a reverse merger that will result in Arrival becoming a public company traded on the NASDAQ Capital Market under the new ticker symbol “ARVL.”  The transaction values the combined company at an implied enterprise value of approximately $5.4 billion.


If you own CIIG shares and wish to discuss this investigation or have any questions concerning this notice or your rights or interests, visit our website:


https://www.weisslawllp.com/CIIG/


Or please contact:


Joshua Rubin, Esq.

WeissLaw LLP
1500 Broadway, 16th Floor
New York, NY  10036
(212) 682-3025
(888) 593-4771
[email protected]

WeissLaw is investigating whether CIIG’s board acted in the best interest of CIIG’s public stockholders in agreeing to the proposed transaction, whether the board was fully informed as to the valuation of Arrival, and whether all information regarding the process undertaken by the board and the valuation of the transaction will be fully and fairly disclosed to CIIG’s public shareholders. 

WeissLaw LLP has litigated hundreds of stockholder class and derivative actions for violations of corporate and fiduciary duties.  We have recovered over a billion dollars for defrauded clients and obtained important corporate governance relief in many of these cases.  If you have information or would like legal advice concerning possible corporate wrongdoing (including insider trading, waste of corporate assets, accounting fraud, or materially misleading information), consumer fraud (including false advertising, defective products, or other deceptive business practices), or anti-trust violations, please email us at [email protected]

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/shareholder-alert-weisslaw-llp-investigates-ciig-merger-corp-301176552.html

SOURCE WeissLaw LLP

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Supernus Pharmaceuticals, Inc. (SUPN) on Behalf of Investors

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Supernus Pharmaceuticals, Inc. (SUPN) on Behalf of Investors

LOS ANGELES–(BUSINESS WIRE)–Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Supernus Pharmaceuticals, Inc. (“Supernus” or the “Company”) (NASDAQ: SUPN) investors concerning the Company’s possible violations of the federal securities laws.

If you suffered a loss on your Supernus investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/supernus-pharmaceuticals-inc/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.

On November 9, 2020, after the market closed, Supernus disclosed receipt of a complete response letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its new drug application (“NDA”) for SPN-812 for the treatment of ADHD in pediatric patients aged 6-17 years old. According to the CRL, the NDA “is not ready for approval in its present form.” Among other things, “[t]he primary issue cited in the SPN-812 CRL relates to the Company’s in-house laboratory that conducts analytical testing, which recently moved to a new location.”

On this news, Supernus’s stock price fell $3.88 per share, or approximately 16%, to close at $21.08 per share on November 10, 2020, thereby injuring investors.

Follow us for updates on LinkedIn, Twitter, or Facebook.

Whistleblower Notice: Persons with non-public information regarding Supernus should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program. Under the program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Charles H. Linehan at 310-201-9150 or 888-773-9224 or email [email protected].

About GPM

Glancy Prongay & Murray LLP is a premier law firm representing investors and consumers in securities litigation and other complex class action litigation. ISS Securities Class Action Services has consistently ranked GPM in its annual SCAS Top 50 Report. In 2018, GPM was ranked a top five law firm in number of securities class action settlements, and a top six law firm for total dollar size of settlements. With four offices across the country, GPM’s nearly 40 attorneys have won groundbreaking rulings and recovered billions of dollars for investors and consumers in securities, antitrust, consumer, and employment class actions. GPM’s lawyers have handled cases covering a wide spectrum of corporate misconduct including cases involving financial restatements, internal control weaknesses, earnings management, fraudulent earnings guidance and forward looking statements, auditor misconduct, insider trading, violations of FDA regulations, actions resulting in FDA and DOJ investigations, and many other forms of corporate misconduct. GPM’s attorneys have worked on securities cases relating to nearly all industries and sectors in the financial markets, including, energy, consumer discretionary, consumer staples, real estate and REITs, financial, insurance, information technology, health care, biotech, cryptocurrency, medical devices, and many more. GPM’s past successes have been widely covered by leading news and industry publications such as The Wall Street Journal, The Financial Times, Bloomberg Businessweek, Reuters, the Associated Press, Barron’s, Investor’s Business Daily, Forbes, and Money.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Glancy Prongay & Murray LLP, Los Angeles

Charles H. Linehan, 310-201-9150 or 888-773-9224

1925 Century Park East, Suite 2100

Los Angeles, CA 90067

www.glancylaw.com

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Legal Professional Services

MEDIA:

Logo
Logo

ROSEN, TOP RANKED NATIONAL INVESTOR ATTORNEYS, Reminds Loop Industries, Inc. Investors of Important Deadline in Securities Class Action; Encourages Investors with Losses in Excess of $100K to Contact the Firm – LOOP

PR Newswire

NEW YORK, Nov. 18, 2020 /PRNewswire/ — Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Loop Industries, Inc. (NASDAQ: LOOP) between September 24, 2018 and October 12, 2020, inclusive (the “Class Period”), of the important December 14, 2020 lead plaintiff deadline in securities class action. The lawsuit seeks to recover damages for Loop investors under the federal securities laws.

To join the Loop class action, go to http://www.rosenlegal.com/cases-register-1969.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action.

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Loop scientists were encouraged to misrepresent the results of Loop’s purportedly proprietary process; (2) Loop did not have the technology to break PET down to its base chemicals at a recovery rate of 100%; (3) as a result, the Company was unlikely to realize the purported benefits of Loop’s announced partnerships with Indorama and Thyssenkrupp; and (4) as a result of the foregoing, defendants’ positive statements about Loop’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than December 14, 2020. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, go to http://www.rosenlegal.com/cases-register-1969.html or to discuss your rights or interests regarding this class action, please contact Phillip Kim, Esq. of Rosen Law Firm toll free at 866-767-3653 or via e-mail at [email protected] or [email protected].

NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY RETAIN COUNSEL OF YOUR CHOICE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. AN INVESTOR’S ABILITY TO SHARE IN ANY POTENTIAL FUTURE RECOVERY IS NOT DEPENDENT UPON SERVING AS LEAD PLAINTIFF.

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

Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm’s attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors. Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

      Laurence Rosen, Esq.
      Phillip Kim, Esq.
      The Rosen Law Firm, P.A.
      275 Madison Avenue, 40th Floor
      New York, NY 10016
      Tel: (212) 686-1060
      Toll Free: (866) 767-3653
      Fax: (212) 202-3827
      [email protected]
      [email protected]
      [email protected]
      www.rosenlegal.com

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/rosen-top-ranked-national-investor-attorneys-reminds-loop-industries-inc-investors-of-important-deadline-in-securities-class-action-encourages-investors-with-losses-in-excess-of-100k-to-contact-the-firm–loop-301176512.html

SOURCE Rosen Law Firm, P.A.

GOL announces Monthly Investor Update: Capacity, Cash Consumption and Liquidity

Capacity grows to 363 flights a day to meet a 34% increase in passenger demand;

Consolidated gross sales of R$827 million, with an average load factor of 78%;

GOL maintains a strong liquidity position, with no significant debt maturities until 2024.

PR Newswire

SÃO PAULO, Nov. 18, 2020 /PRNewswire/ —   GOL Linhas Aéreas Inteligentes S.A. (NYSE: GOL and B3: GOLL4), (“GOL” or “Company”), Brazil’s largest airline, today provides its Investor Update for the month of October of 2020. All information is presented in Brazilian Reais (R$). The information below is preliminary and unaudited.

Since the last monthly update on October 9, 2020, GOL increased its capacity to an average of 363 flights per day, a 34% increase from an average of 270 daily flights in September. On peak days, the Company operated 500 daily flights in October to service the 34% month-over-month uptick in demand for air travel. GOL’s consolidated gross sales for the month were R$827 million and the average load factor was 78%, in line with previous months.

“After the big bump in sales during Brazil’s winter season, we sustained that growth with a steady increase in October,” said Paulo Kakinoff, CEO. “We expect sales to grow again this month ahead of a busy Summer season and anticipate that we will end the year operating all destinations served pre-pandemic. However, any addition of capacity to our network must meet clear criteria of profitability to guarantee the sustainable resumption of operations.”

The Company ended October 2020 with a total fleet of 128 B737s. With 87 aircraft operating in its network, the planned re-opening of three bases and an increase in flights between São Paulo and Rio de Janeiro, daily flight operations increased 34% over September 2020 and were equivalent to 52% of the same period last year. During the month, GOL ramped up to a peak of 500 daily flights, increasing frequencies in its hubs in São Paulo, Rio de Janeiro, Fortaleza, Salvador and Brasília. The current network represents even higher levels of connectivity compared to the beginning of the year, with more destinations and faster connections. As a result, GOL is well-positioned in both major and regional markets.

The Company’s cash flow equilibrium has been a driving force of GOL’s efforts during the pandemic. Despite the structural and financial inefficiencies created by having its two operating subsidiaries as separate companies, GOL Management believes the key competitive advantages built over the years ensure GOL’s financial strength. The Company’s cost-efficient structure, support from stakeholders and partners, flexible fleet and network model, and the ongoing and significant return of Customer travel in the domestic market, firmly places GOL in a leadership role in the Brazilian airline industry.

“With no significant debt maturities until 2024, we can use our capacity discipline to expand profitability as operations continue to resume,” added Kakinoff.

Delivering Cash Equilibrium as Planned

October 2020 observed a 38% growth in the search for GOL airline tickets, compared to the average search numbers in 3Q20. On specific dates this metric was higher than the same day in 2019, an important sign of returning consumer confidence. Because of this greater interest, the Company recorded a 25% increase in sales across all channels when compared to the average sales reported in 3Q20. With the addition of flights during the month, the revenue from passengers transported increased 21% over September, with better yield efficiency than competitors through GOL’s rational capacity management.

During the month, GOL had a net cash consumption (“burn”) of R$1 million/day, excluding include amortizations of bank debt and interest paid on bonds, which is an improvement in the net cash consumption of R$3 million/day that GOL had forecast for this period.

For the remainder of 2020 (November-December), assuming expected revenues and same items described above, the Company maintains a conservative estimate for a net cash consumption (“burn”) of approximately R$3 million/day. Prior to payment of lease and financial expenses, net cash generation (“earn”) is estimated at approximately R$1 million/day.

Preserving the Company’s Balance Sheet Liquidity

The Company ended the month with approximately R$2.2 billion in total liquidity. Including the financeable amounts of deposits and unencumbered assets, GOL’s potential liquidity sources total approximately R$6 billion. The average maturity of the Company’s long-term debt, excluding aircraft leases and perpetual notes, is nearly three years.

“We have addressed all the relevant financial obligations provided for in our cash flow, and we have a solid partnership with the main providers of working capital. The financial management since the beginning of this pandemic reflects GOL’s commitment to its investors. Our focus continues to be on having a sound capital structure and strengthening the balance sheet through the recovery period,” stated Richard Lark, CFO.

Increasing GOL’s Flight Capacity to Meet Demand

Through the end of October 2020, GOL reduced its fleet by 11 Boeing 737 leased aircraft and plans to return other three aircraft by year-end. Aircraft returns were part of the last year’s fleet plan and did not require contractual alterations, as the Company’s plan had already incorporated the flexibility to adjust to the volatility of the air travel business.

GOL has also retained even more asset flexibility, as its existing contracts allow it to reduce its fleet by up to another 30 aircraft in 2021-2022 if needed, which can be further reduced if demand trends lower. Additionally, the Company reduced its 2020-2022 Boeing 737 MAX deliveries by 34 aircraft.

These cancellations represent a definitive reduction in capital expenditures for aircraft acquisition advances (PDPs) and address the Company’s capacity planning for the coming years, with plans to fully finance all aircraft expenditures and engine overhauls remaining in 2020.

The Company’s fleet operating model will continue to provide significant competitive advantages. GOL does not have widebody aircraft or aircraft financed in capital markets structures, EETCs or finance leases. Its fleet consists of 100% operating leases and narrow-body aircraft that can operate in all domestic, regional and international markets.

GOL’s aircraft contracts are adjusted to the expected recovery of demand through the remainder of 2020 and in 2021 and also will provide an effective reduction in the Company’s unit operating costs. Additionally, GOL has reduced its fixed costs by converting a portion of its monthly lease payments to variable power-by-the-hour.

Maintaining a Conservative Cash Forecast

Matching capacity to demand has always been a competitive advantage in the Company’s fleet management. October 2020 showed continued demand recovery over September 2020 and provided better visibility into the last quarter of the year. GOL maintains significant flexibility to respond to the prevailing demand trends.

In November, GOL increased its capacity to approximately 372 flights per day, and 450 daily flights on peak days, placing the Company’s operations at around 50% of the flight schedule in November 2019. During this current month, GOL will be operating 94 aircraft in its network.

Commented Kakinoff: “Our single-type fleet operating model and dominant position in Brazil’s high-density traffic hubs enables us to quickly add routes to meet demand, while maintaining discipline on capacity and profitability.”

For 4Q20, GOL expects to maintain personnel costs reduced at up to 40% of pre-pandemic levels.

On these conservative assumptions, and with the increase in operational volumes and sales, GOL has improved its operating cash flow equilibrium. The Company estimates that it has sufficient liquidity to finance its working capital, expenses and debt service during this growth phase. Based on GOL’s current liquidity levels and having converted a significant portion of fixed payroll and fleet costs into variable costs, the Company will maintain its market unit cost leadership.

The Boeing 737 MAX is nearing approval to begin operating, and its return to service will increase our cost savings, as the MAX-8s consume 15% less fuel than the 737-800 NG aircraft. Resuming high aircraft utilization and expanding its network predominantly concentrated in Brazil will enable GOL to continue to operate with the lowest and most variable cost structure among its peers. In the best-case scenario, the Company estimates that the MAX will return to operation in its fleet by the end of 2020. 

This competitive advantage is further evidenced by the actions of GOL’s stakeholders who have supported the Company during this global crisis. GOL Management fully honored its commitments with the global capital markets and the Company is the only airline in Latin America to have returned capital to investors in 2020. GOL expects these actions will continue to define the Company, and it counts on the continued support and trust of GOL’s stakeholders and partners investing in the recovery of the Brazilian market.

Building Trust with the Resumption of Travel

During the months of January to October, the Company obtained the top rating on the Consumidor.gov.br portal, leading in the Solution Index, the Satisfaction Index and the Average Response Time.

Kakinoff commented: “Through our values of Service and Safety, our Customers are increasingly confident in flying. We are working on every front, including ticket sales, customer service, boarding, the in-flight experience and disembarkation services, to ensure that our travelers are comfortable with the entire flight experience. We believe Customers will want to fly with the airline they trust most on Service and Safety, both during and after the pandemic”.

In response to the pandemic, GOL reinforced all of its procedures to ensure the Health and Safety of its Customers and Employees, with increased attention to the cleaning of aircraft, including the use of a hospital-grade disinfectant for the service galleries and all areas of intense use in the cabin and the cockpit.

GOL’s aircraft have HEPA air filters, which eliminates 99.9% of particles such as bacteria, viruses and other impurities on board, allowing the circulation of purer air. In addition, each set of 3 to 7 seats rows has its own air circulation system, making minimal air circulation among passengers.

GOL also equipped its Employees with gloves and masks, in addition to making alcohol-based gel available to the crew and Customers on the aircraft. The use of masks on board, mandatory as of May 10, was well-accepted by Customers compared to the response in other countries.

Communication has been a priority in GOL’s operations. Airport Employees and Crew members are fully prepared advising Customers on social distancing measures and on-board health and safety practices. In addition, the Company has observed exemplary behavior of travelers in relation to their concern for their own safety and that of everyone around them.

As a result of these actions taken by the Company, its Employees and its Customers, on average, active GOL Employees have tested positively for COVID-19 only once in every 1,701 flights, an astonishingly low rate, of which the Company is proud.


Key Metrics – October 2020 (preliminary and unaudited)


Liquidity


October/2020


∆ September/2020

Total liquidity

Deposits

Unencumbered assets

R$2.2 billion

R$2.3 billion

R$1.3 billion

-1%

+1%


Net Operating Cash Consumption¹


October/2020


∆ September/2020

Cash outflows

Cash inflows

Net cash consumption (“burn”)

R$(25) MM/day


 R$24 MM/day 

R$(1) MM/day

+17%

+28%

NM


Fleet


October/2020


∆ September/2020

Total (average)

Grounded aircraft (average)

Operating aircraft (average)

Flights per day (average)

Network destinations

128

41

87

363 (52% of 2019)

63 (23% of 2019)

-1

-17

+16

+34%

+5%


Operating Results


October/2020


∆ September/2020

Seats (000)

ASK (million)

Load factor

Consolidated gross sales (R$MM)

Consolidated gross revenue (R$MM)

1,998

2,317

78.0%

827

603

+38%

+37%

-2.0 p.p.

+3%

+23%


1- Excluding debt service.

Investor Relations

[email protected] 
www.voegol.com.br/ir 
+55(11) 2128-4700

Media Relations

Becky Nye, Montieth & Company
[email protected]

About GOL Linhas Aéreas Inteligentes S.A.

GOL serves more than 36 million passengers annually. With Brazil’s largest network, GOL offers customers more than 750 daily flights to over 100 destinations in Brazil and in South America, the Caribbean and the United States. GOLLOG‘s cargo transportation and logistics business serves more than 3,400 Brazilian municipalities and more than 200 international destinations in 95 countries. SMILES allows over 16 million registered clients to accumulate miles and redeem tickets to more than 700 destinations worldwide on the GOL partner network. Headquartered in São Paulo, GOL has a team of approximately 15,000 highly skilled aviation professionals and operates a fleet of 128 Boeing 737 aircraft, delivering Brazil’s top on-time performance and an industry leading 19-year safety record. GOL has invested billions of Reais in facilities, products and services and technology to enhance the customer experience in the air and on the ground. GOL’s shares are traded on the NYSE (GOL) and the B3 (GOLL4). For further information, visit www.voegol.com.br/ir.

Disclaimer
The information contained in this press release has not been subject to any independent audit or review and contains “forward-looking” statements, estimates and projections that relate to future events, which are, by their nature, subject to significant risks and uncertainties. All statements other than statements of historical fact contained in this press release including, without limitation, those regarding GOL’s future financial position and results of operations, strategy, plans, objectives, goals and targets, future developments in the markets in which GOL operates or is seeking to operate, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “will”, “may”, “project”, “estimate”, “anticipate”, “predict”, “seek”, “should” or similar words or expressions, are forward-looking statements. The future events referred to in these forward-looking statements involve known and unknown risks, uncertainties, contingencies and other factors, many of which are beyond GOL’s control, that may cause actual results, performance or events to differ materially from those expressed or implied in these statements. These forward-looking statements are based on numerous assumptions regarding GOL’s present and future business strategies and the environment in which GOL will operate in the future and are not a guarantee of future performance. Such forward-looking statements speak only as at the date on which they are made. None of GOL or any of its affiliates, officers, directors, employees and agents undertakes any duty or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. None of GOL or any of its affiliates, officers, directors, employees, professional advisors and agents make any representation, warranty or prediction that the results anticipated by such forward-looking statements will be achieved, and such forward-looking statements represent, in each case, only one of many possible scenarios and should not be viewed as the most likely or standard scenario. Although GOL believes that the estimates and projections in these forward-looking statements are reasonable, they may prove materially incorrect and actual results may materially differ. As a result, you should not rely on these forward-looking statements.

Non-GAAP Measures
To be consistent with industry practice, GOL discloses so-called non-GAAP financial measures which are not recognized under IFRS or U.S. GAAP, including “Net Debt”, “Adjusted Net Debt”, “total liquidity” and “EBITDA”. The Company’s management believes that disclosure of non-GAAP measures provides useful information to investors, financial analysts and the public in their review of its operating performance and their comparison of its operating performance to the operating performance of other companies in the same industry and other industries. However, these non-GAAP items do not have standardized meanings and may not be directly comparable to similarly-titled items adopted by other companies. Potential investors should not rely on information not recognized under IFRS as a substitute for the GAAP measures of earnings or liquidity in making an investment decision.

 

Cision View original content:http://www.prnewswire.com/news-releases/gol-announces-monthly-investor-update-capacity-cash-consumption-and-liquidity-301176559.html

SOURCE GOL Linhas Aéreas Inteligentes S.A.

Data Experts and Enthusiasts From All Over APAC to Get Together at Denodo’s Virtual Annual User Conference

Data Experts and Enthusiasts From All Over APAC to Get Together at Denodo’s Virtual Annual User Conference

Denodo customers, partners, and renowned industry analysts to discuss trends in machine learning, hybrid/multi cloud, data science, data virtualization, and logical data fabric

SINGAPORE–(BUSINESS WIRE)–Denodo, the leader in data virtualization, today announced it will be hosting its 3rd annual user conference, Denodo DataFest, in APAC. Denodo DataFest 2020 will be webcasted as a two-day event with half-day programs scheduled for each day. The event brings together some of the most respectable and well known industry and subject matter experts from across the APAC region, to share their experiences and insights on why logical data fabric, enabled by data virtualization, is the future of data management and the backbone of today’s and tomorrow’s digital enterprises.

Register for the online live stream across APAC, here.

“We are thrilled to be participating in Denodo DataFest 2020 and sharing our logical data fabric journey,” said Johan de Coning, business intelligence manager at Silver Chain Group, Australia. “Data virtualization has been one of the most critical components of our enterprise data architecture, and I am excited to join our peers and other industry experts to be able to exchange ideas that are futuristic, novel, and insightful.”

This complimentary virtual event will enable some of the most well-respected industry analysts, Denodo customers, partners, and prospects to come together and immerse themselves in thought provoking, educational discussions on how logical data fabric is shaping the future of enterprise data management. Some of the most prominent Denodo customers, such as BHP Group, Silver Chain Group, RMIT University, and Crédit Agricole Corporate Investment Bank, Singapore, will be joined by Denodo partners such as Tech Mahindra, DaaS Labs, Wipro, HCL, Mindtree, and many others. As an added bonus, Steve Young, Pro Football Hall of Famer and president & co-founder of HGGC, will offer his perspectives on how to navigate the current economic crisis with prudent technology investments.

“In 2019, APAC became Denodo’s fastest growing region, with some of the largest organizations, such as Silver Chain Group, and BHP Group of Australia, adopting data virtualization as their enterprise data integration and delivery layer,” said Ravi Shankar, senior vice president and chief marketing officer at Denodo. “As DataFest is truly going global this year, I am thrilled to see big-brand customers and partners from the APAC region joining us at DataFest to share their experiences with logical data fabric and Denodo Platform 8.0. Such an assembly of subject matter experts will bring immense value to our audience, who will be joining us not only from the APAC region but from all over the world.”

This event will have something informative and insightful to offer to everyone, in terms of market trends, use cases, demos, product deep dives, expert roundtables, and other types of sessions. Denodo recently launched Denodo Platform 8.0, which is setting the standard for enterprise-wide logical data fabric implementation. DataFest 2020 will highlight innovations in Denodo Platform 8.0 in terms of data science, machine learning, multi-cloud orchestration, and automated infrastructure management which, according to well-known industry analysts, are critical initiatives for every futuristic digital enterprise. Denodo customers and partners have both expressed excitement for this upcoming event.

“Many of our customers in the Asia Pacific region are seeing tremendous value in implementing data virtualization technology for their enterprise data access and data management,” said Deb Mukherji, practice head for Data, Analytics, & AI (ASEAN & North Asia) at Tech Mahindra. “We are very excited to forge a partnership with Denodo, which is one of the best players in the data integration market today. The Denodo DataFest event is probably the best way to get to know many Denodo customers and prospects, and exchange ideas to set the course for the future of data integration and data management. This is our first time sponsoring DataFest, and we are very much looking forward to it.”

Here are some of the highlights of the event:

  • Steve Young, Pro Football Hall of Famer and president & co-founder at HGGC, will offer his perspectives on how to navigate the current economic crisis with prudent technology investments.
  • Forrester analyst Noel Yuhanna and TDWI analyst Philip Russom will lay out their vision of what the future holds for enterprise data fabric and data virtualization.
  • Two of Denodo’s APAC customers will present innovative use cases for data virtualization, as part of the prestigious Data Innovation Award ceremony.

To Participate:

Attend the Online Live Stream in APAC: November 24-25 9:00am SGT | 12:00pm AEDT– Register now.

Please Tweet: News: @Denodo is excited to host annual #DenodoDataFest conference as a complimentary virtual event. Featuring 30+ keynote, technical deep-dive, & solution-focused sessions on advancing #cloud, #analytics & #AI/#ML initiatives with logical #datafabric. www.denododatafest.com

About Denodo

Denodo is the leader in data virtualization providing agile, high performance data integration, data abstraction, and real-time data services across the broadest range of enterprise, cloud, big data, and unstructured data sources at half the cost of traditional approaches. Denodo’s customers across every major industry have gained significant business agility and ROI by enabling faster and easier access to unified business information for agile BI, big data analytics, Web, cloud integration, single-view applications, and enterprise data services. Denodo is well-funded, profitable, and privately held. For more information, visit http://www.denodo.com or call +1 877 556 2531 / +44 (0) 20 7869 8053.

MEDIA CONTACTS:

Vincent Leong –

Vice President, PR, Ying Communications (a FINN Partners company)

email: [email protected]

mobile: +65-90053959

KEYWORDS: California China Australia Singapore North America Asia Pacific Japan United States Australia/Oceania

INDUSTRY KEYWORDS: Data Management Technology Security Other Technology Telecommunications Software Networks Internet Mobile/Wireless Hardware Electronic Design Automation

MEDIA:

Logo
Logo

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Lizhi, Inc. (LIZI) on Behalf of Investors

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Lizhi, Inc. (LIZI) on Behalf of Investors

LOS ANGELES–(BUSINESS WIRE)–Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Lizhi Inc. (“Lizhi” or the “Company”) (NASDAQ: LIZI) investors concerning the Company’s possible violations of the federal securities laws.

If you suffered a loss on your Lizhi investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/lizhi-inc/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.

In January, 2020, Lizhi conducted its initial public offering (“IPO”), issuing 4.1 million American depositary shares (“ADSs”) priced at $11.00 per ADS.

On November 9, 2020, post-market, Lizhi disclosed its financial results for the third quarter of 2020, which included revenue of $53.24 million, $0.77 million lower than consensus estimates.

On this news, Lizhi’s stock price fell $0.25 per share, or 10.5%, to close at $2.13 per share on November 10, 2020.

Follow us for updates on LinkedIn, Twitter, or Facebook.

Whistleblower Notice: Persons with non-public information regarding Lizhi should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program. Under the program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Charles H. Linehan at 310-201-9150 or 888-773-9224 or email [email protected].

About GPM

Glancy Prongay & Murray LLP is a premier law firm representing investors and consumers in securities litigation and other complex class action litigation. ISS Securities Class Action Services has consistently ranked GPM in its annual SCAS Top 50 Report. In 2018, GPM was ranked a top five law firm in number of securities class action settlements, and a top six law firm for total dollar size of settlements. With four offices across the country, GPM’s nearly 40 attorneys have won groundbreaking rulings and recovered billions of dollars for investors and consumers in securities, antitrust, consumer, and employment class actions. GPM’s lawyers have handled cases covering a wide spectrum of corporate misconduct including cases involving financial restatements, internal control weaknesses, earnings management, fraudulent earnings guidance and forward looking statements, auditor misconduct, insider trading, violations of FDA regulations, actions resulting in FDA and DOJ investigations, and many other forms of corporate misconduct. GPM’s attorneys have worked on securities cases relating to nearly all industries and sectors in the financial markets, including energy, consumer discretionary, consumer staples, real estate and REITs, financial, insurance, information technology, health care, biotech, cryptocurrency, medical devices, and many more. GPM’s past successes have been widely covered by leading news and industry publications such as The Wall Street Journal, The Financial Times, Bloomberg Businessweek, Reuters, the Associated Press, Barron’s, Investor’s Business Daily, Forbes, and Money.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Glancy Prongay & Murray LLP, Los Angeles

Charles H. Linehan, 310-201-9150 or 888-773-9224

1925 Century Park East, Suite 2100

Los Angeles, CA 90067

www.glancylaw.com

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Legal Professional Services

MEDIA:

Logo
Logo

Prevail Therapeutics Granted Composition of Matter Patent for Experimental Gene Therapy Program PR001

NEW YORK, Nov. 18, 2020 (GLOBE NEWSWIRE) — Prevail Therapeutics Inc. (Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the United States Patent and Trademark Office (USPTO) on November 17, 2020 issued a composition of matter patent, U.S. Patent No. 10,837,028, with claims directed to the AAV vector used in PR001, Prevail’s experimental gene therapy program for the treatment of Parkinson’s disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD). The base patent term extends until October 3, 2038, excluding patent term extensions or coverage in additional related patent filings.

“We are excited to make important progress this year with PR001, which is being evaluated in the Phase 1/2 PROPEL trial for patients with Parkinson’s disease with GBA1 mutations and in the Phase 1/2 PROVIDE trial for patients with Type 2 Gaucher disease,” said Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail. “We are advancing clinical development of PR001 to make a potentially transformative difference for these patients who currently have no approved treatment options.”

The Company recently announced that patient dosing has continued in the Phase 1/2 PROPEL clinical trial of PR001 for PD-GBA patients, and it expects to provide the next biomarker and safety analysis on a subset of patients in the PROPEL trial by mid-2021. The Company expects to initiate enrollment of the Phase 1/2 PROVIDE clinical trial of PR001 for Type 2 Gaucher disease patients in the fourth quarter of 2020 and currently anticipates it will provide the next update on PR001 biomarker and safety data for nGD in 2021.

The U.S. Food and Drug Administration has granted Fast Track designations for PR001 for the treatment of PD-GBA and nGD. In addition, the FDA granted PR001 Rare Pediatric Disease designation for the treatment of nGD, and Orphan Drug designation for the treatment of patients with Gaucher disease.

About Prevail Therapeutics

Prevail is a gene therapy company leveraging breakthroughs in human genetics with the goal of developing and commercializing disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases. The Company is developing PR001 for patients with Parkinson’s disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD); PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN); and PR004 for patients with certain synucleinopathies.

Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson’s with GBA and OrbiMed, and is headquartered in New York, NY.

Forward-Looking Statements Related to Prevail

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning the potential for Prevail’s gene therapy candidates to make a transformative difference for patients with neurodegenerative diseases; the expected timing of reporting additional interim data on a subset of patients from the PROPEL trial; and the anticipated timing of enrollment of and the next update on data from the PROVIDE trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Prevail’s novel approach to gene therapy makes it difficult to predict the time, cost and potential success of product candidate development or regulatory approval; Prevail’s gene therapy programs may not meet safety and efficacy levels needed to support ongoing clinical development or regulatory approval; the regulatory landscape for gene therapy is rigorous, complex, uncertain and subject to change; the fact that gene therapies are novel, complex and difficult to manufacture; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in Prevail’s filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” sections of the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Prevail undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Media Contact:

Lisa Qu
Ten Bridge Communications
[email protected]
678-662-9166

Investor Contact:

[email protected]