HUYA Bioscience International Submits HBI-8000 Monotherapy for Adult T-cell Leukemia/Lymphoma for Regulatory Approval in Japan

On October 6, 2020 HUYA Bioscience International (HUYABIOTM ), the leader in accelerating global development of China’s pharmaceutical innovations, reported the submission of a regulatory application to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000 monotherapy for relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL) (Press release, HUYA Bioscience, OCT 6, 2020, View Source [SID1234568175]).

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Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "The submission of the regulatory application in Japan for R/R ATL is a significant milestone for HUYABIO. The durability and strong immuno-oncology properties of HBI-8000 sets the stage for improved cancer treatment of both solid and liquid tumors. We look forward to drug approval and a positive impact on the quality of life of these patients."

The new drug application is based on data from a Phase 2b study that involved 23 patients with aggressive ATL in Japan. These patients all had advanced disease either refractory or relapsed after receiving mogamulizumab and had few effective treatment options. HBI-8000 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile.

"Aggressive ATL is primarily a disease of the elderly with a poor three-year survival rate of 25%. There are few effective treatment options. It remains to be an important unmet medical need in Japan and a challenging public health issue. Clinical data from HBI-8000 has shown the promise to fulfill such a need. Orphan Drug Designation has been granted to HBI-8000 for R/R ATL, and peripheral T-cell lymphoma", said Dr. Bob Goodenow, President of HUYABIO.

About HBI-8000

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATL cells more sensitive to immune cytotoxicity targeting.

Precision Optics to Present at Lytham Partners Virtual Investor Conference

On October 6, 2020 Precision Optics Corporation, Inc. (OTCQB: PEYE), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, reported to participate in a virtual presentation and fireside chat at the October 2020 Lytham Partners Virtual Investor Conference on Wednesday, October 7, 2020 at 2:00pm ET (11:00am PT) (Press release, Precision Optics, OCT 6, 2020, View Source [SID1234568174]).

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A webcast of the presentation will be posted under the investor relations section of Precision Optics’ website at www.poci.com or can be accessed at View Source A replay of the presentation will be available following the event.

Management will also be participating in virtual one-on-one meetings. To arrange a meeting, please contact Robert Blum of Lytham Partners at [email protected] or visit www.lythampartners.com/virtual.

Benitec Biopharma Announces Closing of $11.5 Million Public Offering and Full Exercise of Underwriter’s Option to Purchase Additional Shares

On October 6, 2020 Benitec Biopharma Inc. (NASDAQ: BNTC) ("Benitec" or "the Company"), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on the proprietary DNA-directed RNA interference ("ddRNAi") platform, reported the closing of an underwritten public offering of 3,225,806 shares of its common stock (or common stock equivalents in lieu thereof) at an effective offering price of $3.10 per share of common stock (Press release, Benitec Biopharma, OCT 6, 2020, View Source [SID1234568173]). In addition, the Company also announced that the underwriter fully exercised its over-allotment option to purchase 483,870 additional shares of its common stock.

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H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

The gross proceeds from this offering to the Company are approximately $11.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for the continued advancement of development activities for its product pipeline, general corporate purposes, and strategic growth opportunities.

A registration statement on Form S-1 (File No. 333-246314) relating to these securities was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on October 2, 2020. This offering is being made only by means of a prospectus forming part of the effective registration statement. A final prospectus relating to and describing the terms of the offering has been filed with the SEC. Electronic copies of the final prospectus relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by email at [email protected] or by telephone at 646-975-6996.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 or other jurisdiction.

Regeneron to Report Third Quarter 2020 Financial and Operating Results and Host Conference Call and Webcast on November 5, 2020

On October 6, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its third quarter 2020 financial and operating results on Thursday, November 5, 2020, before the U.S. financial markets open (Press release, Regeneron, OCT 6, 2020, https://www.prnewswire.com/news-releases/regeneron-to-report-third-quarter-2020-financial-and-operating-results-and-host-conference-call-and-webcast-on-november-5-2020-301147030.html [SID1234568172]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 1535889. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

Haemonetics Sets Date for Publishing Second Quarter Fiscal Year 2021 Results: November 4, 2020

On October 6, 2020 Haemonetics Corporation (NYSE:HAE) reported that the Company intends to publish second quarter fiscal year 2021 financial results at 6:00 am EDT on Wednesday, November 4, 2020 (Press release, Haemonetics, OCT 6, 2020, View Source [SID1234568171]). The Company will hold a conference call with investors and analysts to discuss results and answer questions at 8:00 am EDT on November 4, 2020.

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The call can be accessed with the following information:

A live webcast of the call can be accessed on Haemonetics’ investor relations website. Webcast Link: View Source

Webcast replay will be available from November 4, 2020 11:00 am to November 12, 2020 11:00 am EDT.