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Bristol Myers Squibb Announces Dividend Increase

On December 10, 2020 Bristol Myers Squibb (NYSE:BMY) reported that its Board of Directors has declared a quarterly dividend of forty-nine cents ($.49) per share on the $.10 par value common stock of the company (Press release, Bristol-Myers Squibb, DEC 10, 2020, View Source [SID1234573349]). The dividend is payable on February 1, 2021 to stockholders of record at the close of business on January 4, 2021.

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This amount represents an 8.9% increase in the quarterly dividend over last year’s quarterly rate of forty-five cents ($.45) per share. At this quarterly dividend rate, subject to the normal quarterly review by the Board of Directors, the annual dividend rate for the fiscal year 2021 is $1.96 per share. This marks the twelfth consecutive fiscal year that Bristol Myers Squibb increased its dividend payouts.

In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable March 1, 2021 to stockholders of record at the close of business on February 2, 2021.

QIAGEN N.V. announces successful placement of new net share settled convertible bonds and results of offer to non-US holders to sell the outstanding convertible notes due 2021

On December 10, 2020 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) ("QIAGEN") reported certain terms of the new senior, unsecured net share settled convertible bonds, which may be converted, in part, into ordinary shares of QIAGEN ("Shares"), due 2027 (the "New Bonds") and results of the invitation to sell the outstanding 0.875% convertible notes due 2021 (ISIN: XS1046477581; the "2021 Notes") (Press release, Qiagen, DEC 10, 2020, View Source [SID1234572985]).

The New Bonds Offering

The size of the offering has been increased to $500 million aggregate principal amount. The New Bonds will be issued at 100% of their principal amount, will bear no interest and, unless previously converted, redeemed or repurchased and cancelled, will be redeemed at par value. The initial conversion price will be set at a 55% premium over the reference share price. The reference share price will be equal to the arithmetic average of the daily volume weighted average prices of the Shares on the 2 consecutive trading days commencing on December 10, 2020 on the New York Stock Exchange.

The final terms of the New Bonds will be announced following the determination of the reference share price, expected to occur post close of trading on the New York Stock Exchange on December 11, 2020.

Under the terms of the New Bonds offering, QIAGEN will agree not to sell any securities that are substantially similar to the New Bonds or its Shares for a lock-up period ending 90 days following the settlement date, subject to certain exceptions and waiver by BofA Securities, Deutsche Bank Aktiengesellschaft and Goldman Sachs International as Joint Global Coordinators.

The Invitation to Sell the 2021 Notes

As at the close of the bookbuilding process, QIAGEN announces it has agreed to purchase $172.4 million in aggregate principal amount of the outstanding 2021 Notes.

Following the completion of the repurchase, an aggregate principal amount of $4.8 million will remain outstanding.

In respect of 2021 Notes accepted for purchase, QIAGEN will pay a purchase price per 2021 Note equal to the arithmetic average of each of the daily volume weighted average prices of the Shares on the New York Stock Exchange, multiplied by the prevailing conversion ratio applicable on each such day, on the 2 consecutive trading days commencing on December 10, 2020.

Entry into a Material Definitive Agreement.

On December 10, 2020, Propanc Biopharma, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Purchase Agreement") with GW Holdings Group, LLC ("GW"), pursuant to which GW purchased a convertible redeemable promissory note (the "December 2020 GW Note") from the Company in the aggregate principal amount of $131,000, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of GW. The transaction contemplated by the Purchase Agreement closed on or about December 10, 2020 (Filing, 8-K, Propanc, DEC 10, 2020, View Source [SID1234572943]). The Company intends to use the net proceeds ($125,000) from the December 2020 GW Note for general working capital purposes. Pursuant to the terms of the Purchase Agreement, the Company paid GW’s legal fees and expenses in the aggregate amount of $6,000.

The Purchase Agreement contains such representations, warranties and covenants as are typical for a transaction of this nature.

The maturity date of the December 2020 GW Note is December 10, 2021 (the "Maturity Date"). The December 2020 GW Note shall bear interest at a rate of 8% per annum, which interest may be paid by the Company to GW in shares of common stock, but shall not be payable until the December 2020 GW Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment, as described below. GW has the option to convert all or any amount of the principal face amount of the December 2020 GW Note, starting on June 18, 2021 and ending on the Maturity Date. The December 2020 GW Note may be converted into shares of the Company’s common stock equal to 40% discount of the lowest closing bid price of the common stock for the ten trading days immediately prior to the delivery of a notice of conversion, provided, however, such conversion shall not be effected to the extent that GW together with any of its affiliates would beneficially own in excess of 4.99%, which may be increased up to 9.99% upon 61 days’ prior written notice by GW to the Company. The Company may redeem the December 2020 GW Note as follows: (i) if the redemption occurs within the first 60 days, then an amount equal to 115% of the face amount of the note plus any accrued interest, (ii) if the redemption occurs after the 61st day but on or before the 120th day following the issuance of the note, then an amount equal to 125% of the face amount of the note along with any accrued interest, (iii) if the redemption occurs after the 121st day but on or before the 180th day following the issuance of the note, then an amount equal to 135% of the face amount of the note along with any accrued interest.

In the event of a default, without demand, presentment or notice, the December 2020 GW Note shall become immediately due and payable.

Other than as described above, the December 2020 GW Note contains certain events of default, including failure to timely issue shares upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations or warranties, insolvency, bankruptcy, liquidation and failure by the Company to pay the principal and interest due under the December 2020 GW Note.

The foregoing description of the Purchase Agreement and the December 2020 GW Note does not purport to be complete and is qualified in their entirety by reference to the full text of the Purchase Agreement and the December 2020 GW Note, which are filed as Exhibits 10.1 and 4.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

Kazia to Collaborate with Pacific Pediatric Neuro-Oncology Consortium (PNOC) for New Paxalisib Combination Study in DIPG

On December 10, 2020 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported that it has executed a Letter of Intent with the Pacific Pediatric Neuro-Oncology Consortium (PNOC) to launch a clinical trial of multiple therapies, including Kazia’s investigational new drug, paxalisib (formerly GDC-0084), in diffuse midline gliomas including diffuse intrinsic pontine glioma (DIPG) (Press release, Kazia Therapeutics, DEC 10, 2020, View Source [SID1234572773]).

The new clinical trial, PNOC022, will employ an adaptive trial design to test several therapies in different combinations and in different subsets of patients. In addition to paxalisib, the other therapies involved will initially include ONC201, manufactured by Oncoceutics, Inc, and panobinostat, manufactured by SecuraBio, Inc. The study is expected to open initially in the United States and will then expand to other countries during CY2021.

Key Points

PNOC022 uses cutting-edge clinical trial design to efficiently and rapidly evaluate combination therapies in DIPG, under the leadership of world experts in the field
Lead investigator is Professor Sabine Mueller, a leading paediatric neuro-oncologist and co-founder of PNOC
Study is guided by Australian research at University of Newcastle, under leadership of Associate Professor Matt Dun, who serves as a scientific advisor
Combination approach builds on recent positive data from St Jude SJPI3K study (NCT03696355) with paxalisib as single agent in DIPG, and brings together several of the most promising candidates in the global pipeline for DIPG
Kazia will provide paxalisib investigational product; study is fully funded by PNOC
Kazia CEO, Dr James Garner, commented, "DIPG and diffuse midline gliomas have emerged as an exciting second front in the development of paxalisib as a brain cancer therapy. Work by Dr Chris Tinkle and colleagues at St Jude Children’s Research Hospital has taught us a great deal about how to use this drug in a paediatric population. In parallel, extensive laboratory research by Associate Professor Matt Dun and colleagues has generated a rich and comprehensive data set to inform combination use. We are delighted to now have the opportunity to work with the PNOC team to bring these insights together and to take paxalisib into the next chapter of its development as a potential therapy for DIPG."

Clinical Trial Design

PNOC022 will enrol children and young adults with diffuse midline gliomas, a category of brain tumours that includes DIPG. The study will include separate cohorts comprising patients with newly diagnosed disease, patients who have completed initial radiotherapy, and patients who have experienced disease progression after treatment.

At the outset, all patients will be treated with ONC201, combined with either paxalisib or panobinostat. The study employs an adaptive design, in which different arms will opened and closed based on emerging preclinical and clinical data. The primary endpoint will be the proportion of patients progression-free at six months (PFS6) for newly diagnosed patients, and overall survival (OS) for recurrent patients.

The lead investigator will be Professor Sabine Mueller, a board-certified neurologist and paediatric neuro-oncologist whose research focuses on novel therapies in childhood brain cancer. Professor Mueller holds an academic appointment in the Department of Neurology, Neurosurgery and Pediatrics at the University of California, San Francisco (UCSF) and serves as head of the clinical programme at the DMG Centre at the Children’s Hospital of the University of Zurich. She obtained her medical degree from the University of Hamburg, and also holds a PhD in molecular biology.

Professor Mueller commented, "DIPG remains one of the most challenging of childhood cancers. No drug treatment has ever demonstrated meaningful efficacy. The PNOC022 study brings a different approach, uniting the best of preclinical research with novel clinical trial techniques. We look forward to commencing enrolment to the study shortly, and very much hope that we are able to generate new hope for patients and their families."

Commencement of the study remains subject to execution of a definitive contract and is dependent on approval by the US FDA and Institutional Review Boards. It is expected that PNOC022 will initially open in the United States in 1H CY2021, with expansion to other countries taking place in CY2021. Discussions are ongoing regarding the potential inclusion of Australian sites in the study.

Australian Scientific Research

The design of the PNOC022 study has been extensively informed by laboratory research in DIPG, and in particular by research undertaken at the University of Newcastle, Hunter Medical Research Institute (HMRI) by Associate Professor Matt Dun and colleagues. The HMRI team has conducted laboratory research with paxalisib for several years and has generated a powerful body of data combining paxalisib with other investigational drugs. This research has been partly funded by RUN DIPG, a not-for-profit organisation led by Associate Professor Dun, the DIPG Collaborative, Defeat DIPG Michael Moiser Foundation and the McDonald Jones Foundation. The robust mechanistic data is expected to be published in high impact scientific journals in coming months.

Pacific Pediatric Neuro-Oncology Consortium (PNOC)

The Pacific Pediatric Neuro-Oncology Consortium (PNOC) is an international consortium, with study sites in the United States, Canada, Swizterland, Europe, India, Israel, and Australia. PNOC is dedicated to bringing new therapies to children and young adults with brain tumours, using the latest scientific understanding to inform a personalised medicine approach.

PNOC comprises 225 leading specialists in childhood brain cancer and is currently driving sixteen international clinical trials. In Australia, the organisation collaborates closely with the Australia and New Zealand Children’s Hematology / Oncology Group (ANZCHOG). PNOC’s research is substantially supported by the PNOC Foundation, the Pediatric Brain Tumor Foundation, and other not-for-profit entities.

Paxalisib Clinical Program

The initiation of this trial will bring the number of ongoing clinical studies of paxalisib in brain cancer to eight.

Indication

Phase

Sponsor

Registration

Glioblastoma

Kazia Therapeutics

NCT03522298

Glioblastoma

II / III

Global Coalition for Adaptive Research

NCT03970447

DIPG & DMGs

St Jude Children’s Research Hospital

NCT03696355

DIPG & DMGs

N/A*

Pacific Pediatric Neuro-Oncology Consortium

(TBD)

Breast Cancer Brain Metastases

Dana-Farber Cancer Institute

NCT03765983

Brain Metastases

Alliance for Clinical Trials in Oncology

NCT03994796

Brain Metastases

Memorial Sloan-Kettering Cancer Center

NCT04192981

Primary CNS Lymphoma

Dana-Farber Cancer Institute

(TBD)

*Note – the PNOC022 has not adopted a ‘phase’ designation and is described as an ‘adaptive platform study’

Next Steps

Recruitment to this study is expected to commence in 1H CY2021.

Protagonist Therapeutics, Inc. Announces Pricing of $100 Million Public Offering of Common Stock

On December 10, 2020 Protagonist Therapeutics, Inc. (Nasdaq: PTGX), a clinical stage biopharmaceutical company, reported the pricing of its previously announced underwritten public offering of 4,761,904 shares of its common stock at a price to the public of $21.00 per share (Press release, Protagonist, DEC 10, 2020, View Source [SID1234572710]). Gross proceeds to Protagonist from the offering are expected to be $100 million, before deducting underwriting discounts and commissions and offering expenses. All of the shares of common stock are being offered by Protagonist. In addition, Protagonist has granted the underwriters a 30-day option to purchase up to 714,285 additional shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about December 15, 2020, subject to satisfaction of customary closing conditions.

J.P. Morgan Securities LLC, SVB Leerink LLC, Piper Sandler & Co. and BMO Capital Markets Corp. are acting as joint book-running managers for the offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC) on December 10, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and a final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. The offering is being made only by means of a prospectus supplement and accompanying prospectus. Copies of the prospectus supplement and the accompanying prospectus related to the offering may be obtained, when available, from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by email at [email protected]; from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected]; or from BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627 or by email at [email protected].

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.