AcelRx to announce fourth quarter 2018 results and provide a corporate update on Thursday, March 7th, 2019

On February 22, 2019 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company, reported that it will release fourth quarter and annual financial results after market close on Thursday, March 7th, 2019 (Press release, AcelRx Pharmaceuticals, FEB 22, 2019, View Source [SID1234533592]). AcelRx management will host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on March 7, 2019 to discuss the financial results and provide a corporate update.

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Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors page of the company’s website at www.acelrx.com and clicking on the webcast link on the Investors home page.

A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company’s website at www.acelrx.com.

Elpiscience Announces Clinical Trial Approval of ES101 in China

On February 22, 2019 Elpiscience Biopharma, Ltd. reported that the bispecific antibody ES101 has been approved by the Center for Drug Evaluation (CDE) for clinical trials in China (Press release, Elpiscience, FEB 22, 2019, View Source;id=1311 [SID1234536920]). ES101 is a first-in-class, bispecific antibody targeting both PD-L1 and 4-1BB, where 4-1BB-induced T cell activation is dependent on the binding to PD-L1 in the tumor microenvironment. The combination of "de-brake" and "add-gas" ideas not only greatly improved the efficacy of the drug, but also avoided the toxicity that 4-1BB single agent may have. This would solve the problem that 4-1BB monoclonal antibodies have encountered in clinical development. In the mean time, on February 19th, Inhibrx, Elpiscience’s US partner of ES101, announced the dosing of first patient of ES101 in the US. With ES101 being tested in clinical trials both in China and the US, it is expected to benefit cancer patients worldwide.

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Dr. Darren Ji, CEO of Elpiscience, said: "ES101 represents the arrival of the next generation of cancer immunotherapy beyond PD-1/PD-L1. As a first-in-class bispecific antibody, ES101 is expected to bring a transformative treatment to cancer patients on top of the existing therapies. We are delighted to witness this historical moment, which would have marked a small step for Elpiscience and its partner, and a giant leap for patients."

About ES101

ES101 is a tetravalent bispecific antibody that contains four binding domains, two targeting PD-L1 and two targeting 4-1BB, with a molecular weight being only two-thirds of that of an conventional antibody. Based on the high expression of PD-L1 in the tumor microenvironment and an unique antibody engineering, ES101 can conditionally activate 4-1BB upon binding to PD-L1. This would allow for a more efficient tumor killing by immune cells.

First-in-Human Trial Using BXQ-350 for the Treatment of Cancer

On February 22, 2019 Bexion Pharmaceuticals, Inc. (Bexion) reported the opening of Part 3 of their Phase I First-In-Human Trial using BXQ-350 for the treatment of cancer (Press release, Bexion, FEB 22, 2019, View Source [SID1234533802]). This trial was designed to determine the maximum tolerated dose of BXQ-350 and to characterize its safety and pharmacokinetics.

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The Phase I Part 1 study showed that BXQ-350 was well tolerated at all five doses tested with no dose limiting toxicities observed and with no serious adverse events attributed to the therapy. Part 2 tested the highest dose in an additional 36 solid tumor patients. Preliminary data support a safe and tolerable drug profile. The purpose of Part 3 will be to explore safety, and additional indications in rare and gastrointestinal tumors.

"By enrolling patients in Part 3, we hope to gain a better understanding of the potential of BXQ-350 in treating cancer," stated Dr. Ray Takigiku, Founder and CEO of Bexion.

Iovance Biotherapeutics to Host Fourth Quarter and Year-End 2018 Financial Results Conference Call and Webcast on Wednesday, February 27, 2019

On February 22, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it will report its fourth quarter and year-end 2018 financial results on Wednesday, February 27, 2019 (Press release, Iovance Biotherapeutics, FEB 22, 2019, View Source;p=RssLanding&cat=news&id=2388560 [SID1234533577]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. EST.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7055329. The live webcast can be accessed under "News & Events" in the Investors section of the Company’s website at www.iovance.com or at the link: View Source

A replay of the call will be available from February 27, 2019 to March 7, 2019. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and reference the access code 7055329. The archived webcast will be available for thirty days in the Investors section at www.iovance.com.

Bausch Health Announces Pricing Of Private Offering Of Senior Secured Notes And Add-On Unsecured Notes

On February 22, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has priced its previously announced offering of $500,000,000 aggregate principal amount of 5.750% senior secured notes due 2027 (the "Secured Notes") and that Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International) ("BHA"), the Company’s wholly owned indirect subsidiary, has priced its previously announced offering of 8.500% senior unsecured notes due 2027 (the "Unsecured Notes" and, together with the Secured Notes, the "Notes") (Press release, Valeant, FEB 22, 2019, View Source [SID1234533597]). The aggregate size of the offering of the Unsecured Notes is $1,000,000,000, which reflects an increase of $250,000,000 from the previously announced offering size of $750,000,000. The Unsecured Notes will be additional notes and form part of the same series as BHA’s existing 8.500% senior notes due 2027. The Secured Notes will be sold to investors at a price of 100.00% of the principal amount thereof and the Unsecured Notes will be sold to investors at a price of 103.25% of the principal amount thereof (representing a yield to worst of 7.748%). Bausch Health intends to use the net proceeds from the offerings of the Notes, along with cash on hand, to repurchase $1,500 million aggregate purchase price of outstanding notes pursuant to tender offers announced earlier today and upsized this afternoon, including the Company’s outstanding 5.625% Senior Notes due 2021 (the "5.625% Notes") and up to $800,000,000 aggregate purchase price across the Company’s outstanding 5.50% Senior Notes due 2023 (the "5.50% Notes") and 5.875% Senior Notes due 2023 (the "5.875% Notes" and, together with the 5.625% Notes and the 5.50% Notes, the "Existing Notes"), and to pay related fees and expenses. The Company expects the after-tax impact of these transactions to be neutral to 2019 adjusted net income. This announcement does not constitute an offer to purchase or the solicitation of an offer to sell the Existing Notes.

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The Secured Notes will be guaranteed by BHA and each of the Company’s other subsidiaries that are guarantors under the Company’s credit agreement and existing senior notes and will be secured on a first priority basis by liens on the assets that secure the Company’s credit agreement and existing senior secured notes. The Unsecured Notes will be guaranteed by the Company and each of its subsidiaries (other than BHA) that are guarantors under the Company’s credit agreement and existing senior notes. Consummation of the offerings of the Notes is subject to various closing conditions, and there can be no assurance that the Company will be able to successfully complete these transactions on the terms described above, or at all. In addition, neither offering is contingent on the consummation of the other.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis which is exempt from the prospectus requirements of such securities laws.

This news release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.