Bausch Health Announces Pricing Of Private Offering Of Senior Secured Notes

On January 27, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has priced its previously announced offering of $1.0 billion aggregate principal amount of 6.125% senior secured notes due 2027 (the "Notes") (Press release, Bausch Health, JAN 27, 2022, View Source [SID1234607460]). The Notes will be sold to investors at a price of 100% of the principal amount thereof.

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As previously announced, the Company is also seeking to refinance its existing credit agreement (the "Credit Agreement" and such refinancing, the "Credit Agreement Refinancing"). The refinanced Credit Agreement is expected to consist of approximately $2.5 billion of term B loans (the "New Term B Loans") and a $975 million revolving credit facility. The Credit Agreement Refinancing is expected to occur upon completion of the initial public offering ("IPO") of Bausch + Lomb Corporation ("Bausch + Lomb" and such offering, the "Bausch + Lomb IPO") and a related debt financing by Bausch + Lomb (the "Bausch + Lomb Debt Financing").

The proceeds from the offering of the Notes, along with the expected proceeds from the New Term B Loans, the Bausch + Lomb IPO and the repayment of an intercompany note owed to us by Bausch + Lomb (which repayment is expected to be funded by the Bausch + Lomb Debt Financing), are expected to be used to fund the Company’s previously announced conditional redemption in full of its outstanding 6.125% Senior Notes due 2025 (the "6.125% Notes due 2025"), refinance all of the existing Term B Loans, fund the Company’s previously announced conditional partial redemption of its outstanding 9.000% Senior Notes due 2025 (the "9.000% Notes due 2025 and, collectively with the 6.125% Senior Notes due 2025, the "Existing Notes") and to pay related fees, premiums and expenses.

The Notes will be guaranteed by each of the Company’s subsidiaries that are guarantors under the Credit Agreement and existing senior notes and will be secured on a first priority basis by liens on the assets that secure the Credit Agreement and existing senior secured notes.

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.

The redemption of the 6.125% Notes due 2025 is conditioned upon the completion of the Credit Agreement Refinancing (the "6.125% Notes Condition"). The Company intends to discharge the indenture governing the 6.125% Notes due 2025 concurrently with satisfying such 6.125% Notes Condition. The partial redemption of the 9.000% Notes due 2025 is conditioned upon the receipt of aggregate gross proceeds from the Bausch + Lomb IPO, the Bausch + Lomb Debt Financing, the Credit Agreement Refinancing and the offering of the Notes of at least $7.0 billion (the "9.000% Notes Condition" and, together with the 6.125% Notes Condition, the "Conditions"). This announcement does not constitute an offer to purchase or the solicitation of an offer to sell the Existing Notes.

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.

HaemaLogiX and Lonza Collaborate to Manufacture KappaMab, a Multiple Myeloma Drug Candidate

On January 27, 2022 HaemaLogiX Ltd (HaemaLogiX), the clinical-stage biotechnology company developing novel monoclonal antibody therapies for multiple myeloma, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, reported that they have entered into an agreement to manufacture the next clinical batch (cGMP) of HaemaLogiX’s lead multiple myeloma drug candidate, KappaMab (Press release, HaemaLogiX, JAN 27, 2022, View Source [SID1234607458]).

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KappaMab is a monoclonal antibody which binds to a cell surface target called kappa myeloma antigen (KMA) that is only found on myeloma cancer cells and not on normal plasma cells. Specific binding of KappaMab to the myeloma cell enables the patient’s immune system to recognize the cell as abnormal, triggering the natural response to attack and kill the myeloma cell. As a result, only the cancer cells are depleted and normal healthy plasma cells are spared from the patient’s immune system attack.

To date, KappaMab has been tested in three clinical trials where it showed a good safety profile with no dose-limiting toxicities following single and multiple doses[1],[2],[3]. In a recent phase 2b clinical trial, KappaMab synergized with the immune modulator drug (IMiD) lenalidomide in combination with dexamethasone to produce more disease responses and improved quality of response versus case-matched lenalidomide plus dexamethasone alone in patients with relapsed, refractory multiple myeloma[2].

Bryce Carmine, Chairman and CEO, HaemaLogiX, commented: "Multiple myeloma is the second most common haematological cancer worldwide, with an estimated 32,000 new cases and over 12,500 deaths annually in the US alone (2019), and a European incidence roughly equivalent. The incurable nature of multiple myeloma makes it necessary to expand treatment options available to patients. We look forward to taking KappaMab back into the clinic alongside standard of care, and this Lonza agreement is an important step toward providing the drug product for our upcoming trial."

According to the terms of the agreement, Lonza will manufacture drug substance of KappaMab for clinical supply at Lonza’s new state-of-the-art cGMP mammalian manufacturing facility in Guangzhou (CN), which houses two 1,000-liter and two 2,000-liter single-use bioreactors. HaemaLogiX will leverage Lonza’s regulatory expertise, global manufacturing footprint, and extensive experience in manufacturing monoclonal antibodies.

Jeetendra Vaghjiani, Executive Director, Clinical Development & Strategic Marketing, Lonza, commented: "We are looking forward to building a collaboration with HaemaLogiX to help advance their multiple myeloma candidate towards commercial launch. We will leverage our unique flexible offering and state-of-the-art expertise in manufacturing monoclonal antibodies at our site in Guangzhou (CN)."

The target completion date for the drug product is Q4 2022. The drug product will then be used in Australian-based clinical trials, currently scheduled to begin in late 2022.

Johnson & Johnson to Participate in Citi’s 2022 Virtual Healthcare Conference

On January 27, 2022 Johnson & Johnson (NYSE: JNJ) reported that it will participate in Citi’s 2022 Virtual Healthcare Conference on Wednesday, February 23rd, Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices will represent the Company in a session scheduled at 11:00 a.m. (Eastern Time) (Press release, Johnson & Johnson, JAN 27, 2022, View Source;johnson-to-participate-in-citis-2022-virtual-healthcare-conference-301470256.html [SID1234607457]).

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This conference call will be available to investors and other interested parties by visit the Johnson & Johnson website at www.investor.jnj.com.

A webcast and podcast replay will be available approximately 48 hours after the live webcast.

TYME Technologies, Inc. to Host Conference Call and Webcast on Friday, February 11, at 8:30 AM ET

On January 27, 2022 TYME Technologies, Inc. (Nasdaq: TYME) (the "Company" or "TYME"), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that the Company will report its third quarter 2022 financial results on Friday, February 11, 2022, at 8:30 AM ET (Press release, TYME, JAN 27, 2022, View Source [SID1234607456]).

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Richie Cunningham, Chief Executive Officer, and Frank Porfido, Chief Financial Officer, will host a conference call and webcast as follows:

The webcast will be accessible on the Events & Presentations page of the Investors section of the TYME website, tymeinc.com, and will be archived for 90 days following the event.

Following the Company’s presentation, there will be a Q&A session. Management will address both live questions and those submitted in advance via email to [email protected]. The deadline to submit questions for the conference call is 5:00 PM ET on February 7, 2022.

Ostentus Therapeutics, Inc., and City of Hope to Initiate Studies of Novel OST Natural Products for Treatment of Leukemia and Other Cancers

On January 27, 2022 Ostentus Therapeutics, Inc., reported that it has entered into a Sponsored Research Agreement with City of Hope, a world-renowned cancer treatment and research organization and a National Cancer Institute-designated Comprehensive Cancer Center, to conduct preclinical research on OST compounds, which could be used as future therapies for leukemia and other cancers (Press release, City of Hope, JAN 27, 2022, View Source [SID1234607455]).

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"Ostentus is honored to work with City of Hope and Dr. Marcucci on this exciting new phase in the journey of bringing OST proprietary compounds to the market as a potential anti-cancer therapy"

OST compounds are natural products derived from plants native of tropical and subtropical America, which have been used in alternative and traditional medicine. At City of Hope, these compounds will undergo rigorous pharmacologic and toxicologic testing at specialized laboratories. The compounds’ active principles will be investigated individually and in combination to identify their mechanisms of action and anticancer activity.

Guido Marcucci, M.D., director of City of Hope’s Gehr Family Center for Leukemia Research, Chair of the Department of Hematologic Malignancies Translational Science and Chief of its Division of Leukemia Research, will lead the research, which is expected to culminate into a first-in-human clinical trial.

"Ostentus is honored to work with City of Hope and Dr. Marcucci on this exciting new phase in the journey of bringing OST proprietary compounds to the market as a potential anti-cancer therapy," said Elisabetta Graff, Ostentus President and Chief Financial Officer.

"We look forward to working with Ostentus on this exciting preclinical project and the potential application of the OST natural products to our personalized therapeutic approaches for cancer and leukemia patients," Dr. Marcucci added.