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Pulse Biosciences Provides Update on FDA 510(k) Submission for the CellFX System in Dermatology

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Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company, today announced an update on its U.S. Food and Drug Administration (FDA) submission for the CellFX System. Previously, the Company submitted a 510(k) to FDA seeking clearance to commercialize its CellFX System. On February 13, 2020, the Company received a Not Substantially Equivalent (NSE) letter from FDA indicating that, based on the data provided, the Company has not demonstrated that the CellFX System is substantially equivalent to the predicate device. The Company will continue to work with FDA in pursuit of a clearance via a new 510(k) submission and is prepared to provide additional clinical data as required.

We remain highly confident in the CellFX System and its safety and efficacy profile in aesthetic dermatology. We look forward to continuing to work with FDA to obtain a clearance for the CellFX system in dermatology. said Darrin Uecker, President and CEO of Pulse Biosciences. We will continue to generate additional clinical data in support of that effort with the great group of leading dermatologists we have been collaborating with in previous studies.

I am pleased our Board of Directors has approved Pulse Biosciences to take the steps necessary to pursue a rights offering to raise an additional $30 million in net proceeds, said Robert Duggan, Chairman of the Board of Directors. In my position as our largest shareholder, I intend to subscribe to my ownership percent interest and all additional shares that may become available. I am a believer in our team, our technology, and what I perceive to be a substantive human healthcare opportunity.

Business Update Call

The Company has scheduled a business update call for Tuesday, February 18, 2020 at 2:00pm PT. Investors interested in listening to the call may do so by dialing (844) 494-0190 from the US or (508) 637-5580 from outside the US, using conference ID: 2183594. A live and recorded webcast of the call will also be available at http://investors.pulsebiosciences.com/.

Financial Update (Unaudited)

As of December 31, 2019, cash, cash equivalents and investments were $25.4 million.

A registration statement relating to these securities will be filed with the SEC and has not yet become effective. The securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. When available, a copy of the prospectus may be obtained free of charge at the website maintained by the SEC at www.sec.gov. The rights will be issued to all shareholders as of a record date which has yet to be determined. The subscription price for the shares also has yet to be determined. We will provide notice of the record date and subscription price in the future at such time as they are determined.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state. Any offer, if at all, will be made only by means of a prospectus forming a part of the registration statement.

About Pulse Biosciences

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. If approved, the CellFX System will be the first commercial product to harness the distinctive advantages of the Companys proprietary Nano-Pulse Stimulation (NPS) technology to treat a variety of applications for which an optimal solution remains unfulfilled. NPS technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. As a multi-application platform, the CellFX System offers customer value with a utilization-based revenue model across an expanding spectrum of clinical applications. Subject to regulatory approval, the initial commercial use is expected to be in the clearance of common and difficult-to-treat skin lesions that share high demand among patients and practitioners for improved and durable aesthetic outcomes that could lead to greater overall satisfaction.

Pulse Biosciences, CellFX and Nano-Pulse Stimulation are registered trademarks of Pulse Biosciences, Inc.

Caution: Pulse Biosciences CellFX System and Nano-Pulse Stimulation (NPS) technology are for investigational use only.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences expectations regarding regulatory clearance and the timing of FDA filings or approvals, the ability of the Company to prepare and provide data to FDA, the mechanism of action of NPS treatments, current and planned future clinical studies and the results of any such studies, other matters related to its pipeline of product candidates, the Companys market opportunity, the Companys ability to raise capital through the rights offering or consummate the rights offering, the intention of Robert Duggan to participate in the rights offering, the final terms of the rights offering including the offering amount, record date and the subscription price and the related registration statement, future financial performance and other future events. These statements are not historical facts but rather are based on Pulse Biosciences current expectations, estimates, and projections regarding Pulse Biosciences business, operations and other similar or related factors. Words such as may, will, could, would, should, anticipate, predict, potential, continue, expects, intends, plans, projects, believes, estimates, and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

Investors:

Pulse Biosciences

Sandra Gardiner, EVP and CFO

510.241.1077

[email protected]

or

Gilmartin Group

Philip Trip Taylor

415-937-5406

[email protected]

Media:

Tosk Communications

Nadine D. Tosk

504.453.8344

[email protected]

News

Suncity Group Named Title Sponsor for Local Arts Events

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Fully Supports Macau’s Cultural Industry and the Recovery of Macau

 

MACAU, CHINA – Media OutReach – 20 September 2020 – To revitalize the development of Macau’s cultural industry, Suncity Group fully supports the local arts event, rooting for Macau citizens and local artists through series of astonishing and diversified music entertaining events. ‘Suncity Group Rooting for Macau – SIM! Music Festival 2020’ is the first musical performance of series events title sponsored by Suncity Group, ended perfectly at the Cotai Arena, Venetian Macau on September 19.

[View Image]

Maria Helena de Senna Fernandes, Director of Macau Government Tourist Office, Mr. Kevin Ho, Macau Deputy to the National People’s Congress of PRC, Mr. Alvin Chau, Chief Executive Officer and Director of Suncity Group and President of Macau Artistes Association, Dr. Wilfred Wong, President and Executive Director of Sands China Ltd. attended the event 

‘Best Performance Award’ was awarded to Classic heritage- The Final Trigger by Mr. Alvin Chau

[View Image]

Local singers, artists, dancers and more than 200 people from the industry were assembled to organise this music festival

 

With the purpose of ‘reigniting the local performing arts power’, a group of outstanding local singers, artists, dancers and more than 200 people from the industry were assembled to organise this music festival. A total of 12 units did their utmost to compete in the same stage with singing and dancing. There was no cessation to the excitement and the symphony of applause and cheers in the whole night.

 

The organisers have specially invited Mr. Kevin Ho, Macau Deputy to the National People’s Congress of PRC, Dr. Wilfred Wong, President and Executive Director of Sands China Ltd., Mr. Alvin Chau, Chief Executive Officer and Director of Suncity Group and President of Macau Artistes Association to serve as adjudicators and presenters, witnessing and supporting this diversified music festival that belongs to Macau with the other officiating guests. It shot in the arm of Macau’s cultural industry which has been gradually recovering after the pandemic. After a series of stiff competitions and wonderful performances by the participating units, the ‘Best Styling Award’ went to Walk with Scamper, the ‘Best Teamwork Award’ was awarded to Girls Rock, the ‘Best Positive Energy’ was given to Bacalhau Talkshow & Band, and finally the ‘Best Performance Award’ was awarded to Classic heritage- The Final Trigger by Mr. Alvin Chau.

 

Mr. Chau said, ‘2020 is the year full of difficulties. With the impact of the pandemic, performing arts and cultural industries in mainland China and Macau have been hard hit. Most of the large-scale musical performances have also been suspended. “Suncity Group Rooting for Macau – SIM! Music Festival 2020” as the first music festival of this year, it undoubtedly brings more positive energy to Macau society as well as the cultural industry, pro-actively supporting the development of Macau’s industrial diversification.’

 

As the first extraordinary music feast of series events ended, ‘Suncity Group Rooting for Macau – SIM! Full Band festival 2020’, also title sponsored by Suncity Group, comes immediately thereafter and will be held on September 26. 13 teams of local rock bands will spare no effort to inspire local Macau citizens and awaken their rocking soul. There are also DJ performances, cold beer and snacks at that night, creating a diversified and dynamic rock music festival with hyper performances and mouth-watering delicacies. It once again roots for the recovery of Macau’s economy.

 

As an enterprise rooted in Macau, Suncity Group is committed to the motherland and Macau. With actively fulfilling its social responsibilities, the Group strives to support the recovery of cultural industry in mainland China and Macau as well as the diversified development of Macau in cooperating to national policies and long-term development of China. Through the title sponsorship of the series arts events, Suncity Group hopes to bring more positive energy and get the uptick of confidence to the Macau society.

 

High-resolution images can be downloaded in the gallery:

https://dropbox.suncity-group.com/url/0919sim

About Suncity Group

Suncity Group was founded in 2007. Since establishment, Suncity Group has been striving to provide the extraordinary VIP entertainment service for our guests, and we then opened a number of VIP Clubs in various 6-star hotels and resorts throughout Macau with the rapid growth of our business. Meanwhile, we successively set up exclusive VIP Clubs in Manila, Seoul, Incheon, Phnom Penh and Da Nang, etc.

 

Adhering to the spirit of “Innovating With Diversity, Striving For Success”, Suncity Group spared no effort to develop high-end entertainment services and products as well as roll out global VIP loyalty program for the selected members to enjoy entertainment, travel, catering services, luxury shopping and motion picture. Today, the scope of our business covers most sectors, especially in the fields of global travel, film production, concert and event planning, catering and luxury goods.

 

As a Macau born and bred enterprise, Suncity Group is not only devoted to develop the Asian market, but also oriented to expand the global network. In the future, we will surely continue to diversify our VIP entertainment services, attract more exclusive members and make every effort to promote our business in every corner of the world.

 

Official Website | www.suncitygroup.com.mo/en

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CNOOC Limited Announces Commencement of Production at Liuhua 16-2 Oilfield / 20-2 Oilfield Joint Development Project

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HONG KONG, Sept. 20, 2020 /PRNewswire/ — CNOOC Limited (the "Company", SEHK: 00883, NYSE: CEO, TSX: CNU) announced today that Liuhua 16-2 oilfield/ 20-2 oilfield joint development project has commenced production.

Liuhua 16-2 oilfield / 20-2 oilfield joint development project is located in Eastern South China Sea. The average water depth of the joint development project is approximately 410 meters.  One 150,000 DWT FPSO and three underwater production systems are newly built. A total of 26 development wells are planned to be put into production and development. The project is expected to reach its peak production of approximately 72,800 barrels of crude oil per day in 2022.

CNOOC Limited holds 100% interest of Liuhua 16-2 oilfield/ 20-2 oilfield joint development project.

– End –

Notes to Editors:

More information about the Company is available at http://www.cnoocltd.com.

*** *** *** ***

This press release includes "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, including statements regarding expected future events, business prospectus or financial results. The words "expect", "anticipate", "continue", "estimate", "objective", "ongoing", "may", "will", "project", "should", "believe", "plans", "intends" and similar expressions are intended to identify such forward-looking statements. These statements are based on assumptions and analyses made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors the Company believes are appropriate under the circumstances. However, whether actual results and developments will meet the expectations and predictions of the Company depends on a number of risks and uncertainties which could cause the actual results, performance and financial condition to differ materially from the Company’s expectations, including but not limited to those associated with fluctuations in crude oil and natural gas prices, macro-political and economic factors, changes in the tax and fiscal regimes of the host countries in which we operate, the highly competitive nature of the oil and natural gas industry, the exploration and development activities, mergers, acquisitions and divestments activities, environmental responsibility and compliance requirements, foreign operations and cyber system attacks.  For a description of these and other risks and uncertainties, please see the documents the Company files from time to time with the United States Securities and Exchange Commission, including the Annual Report on Form 20-F filed in April of the latest fiscal year.

Consequently, all of the forward-looking statements made in this press release are qualified by these cautionary statements. The Company cannot assure that the results or developments anticipated will be realised or, even if substantially realised, that they will have the expected effect on the Company, its business or operations.

*** *** *** ***

For further enquiries, please contact:

Ms. Jing Liu
Manager, Media & Public Relations
CNOOC Limited
Tel: +86-10-8452-3404
Fax: +86-10-8452-1441
E-mail: [email protected]

Ms. Ada Leung 
Hill+Knowlton Strategies Asia
Tel: +852-2894-6225
Fax: +852-2576-1990
E-mail: [email protected]

Photo – https://photos.prnasia.com/prnh/20200911/2914374-1LOGO?lang=0

 

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SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Odonate Therapeutics, Inc. of Class Action Lawsuit and Upcoming Deadline – ODT

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NEW YORK, Sept. 19, 2020 — Pomerantz LLP announces that a class action lawsuit has been filed against Odonate Therapeutics, Inc.  (“Odonate” or the “Company”) (NASDAQ: ODT) and certain of its officers.   The class action, filed in United States District Court for the Southern District of California, and docketed under 20-cv-01828, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired Odonate securities between December 7, 2017, and August 21, 2020, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased Odonate securities during the class period, you have until November 16, 2020, to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

Odonate was founded in 2013 and is based in San Diego, California.  Odonate is a pharmaceutical company that develops therapeutics for the treatment of cancer.  The Company is focused on developing tesetaxel, an orally administered chemotherapy agent. 

Tesetaxel is in Phase 3 clinical study for patients with locally advanced or metastatic breast cancer (“MBC”), called the CONTESSA trial, which is evaluating tesetaxel in combination with capecitabine in patients with MBC.

The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational, and compliance policies.  Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) tesetaxel was not as safe or well-tolerated as the Company had led investors to believe; (ii) consequently, tesetaxel’s commercial viability as a cancer treatment was overstated; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On August 24, 2020, during pre-market hours, Odonate issued a press release announcing top-line results from the CONTESSA trial.  Although the study met its primary endpoint, tesetaxel plus capecitabine was associated with Grade 3 or higher neutropenia (low levels of white blood cells), which occurred in 71.2% of patients with the combination treatment versus 8.3% for capecitabine alone.  Various other Grade 3 or higher treatment-emergent adverse events (“AEs”) were also associated with tesetaxel plus capecitabine versus capecitabine alone.  Further, discontinuation rates were 4.2% from neutropenia and 3.6% from neuropathy, and the overall discontinuation rate was 23.1% in the treatment group compared to 11.9% in the capecitabine alone group.

On this news, Odonate’s stock price fell $15.21 per share, or 45.35%, to close at $18.33 per share on August 24, 2020.

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

CONTACT: Robert S. Willoughby Pomerantz LLP [email protected]

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