On November 20, 2019 IOTA Pharmaceuticals Ltd (Cambridge, UK) and the Experimental Therapeutic Unit of the Neurology Department of Massachusetts General Hospital (Neurology, MGH, Boston, USA) reported the creation of a new Glioblastoma drug screening pipeline, PHOENIX (Press release, IOTA Pharmaceuticals, NOV 20, 2019, View Source [SID1234551544]).

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Based on IOTA’s GBM Drug Bank1 and MGH’s Glioblastoma patient-derived cell screening platforms2, PHOENIX will translate IOTA’s preclinical work on drug-induced gene expression in established GBM cell lines into a clinic-facing pipeline of effective drug combinations that could form the basis for personalised glioblastoma treatments.

The establishment of PHOENIX and the initial findings which have informed the platform will be reported at the American Society for Neuro Oncology meeting being held later this week in Phoenix, Arizona.

PHOENIX has been created with funds received from The Brain Tumour Charity (UK).

1 GBM Drug Bank-a new resource for glioblastoma drug discovery and informatics research.
2 Patient-Derived Glioma Models: From Patients to Dish to Animals.

Information on the PHOENIX pipeline, and how you can participate, can be obtained from Prof Bakhos Tannous at MGH ([email protected]) and Dr David Bailey at IOTA ([email protected]).

On November 20, 2019 Bristol-Myers Squibb Company (NYSE:BMY) reported that it has completed its acquisition of Celgene Corporation (NASDAQ:CELG) following the receipt of regulatory approval from all government authorities required by the merger agreement and, as announced on April 12, 2019, approval by Bristol-Myers Squibb and Celgene stockholders (Press release, Bristol-Myers Squibb, NOV 20, 2019, View Source [SID1234551529]).

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Upon completion of the acquisition, pursuant to the terms of the merger agreement, Celgene became a wholly owned subsidiary of Bristol-Myers Squibb Company. Under the terms of the merger, Celgene shareholders received for each share, 1.00 share of Bristol-Myers Squibb common stock, $50.00 in cash without interest and one tradeable Contingent Value Right (CVR), which will entitle the holder to receive a payment of $9.00 in cash if certain future regulatory milestones are achieved. Celgene common stock ceased trading as of the close of trading today. On November 21, 2019, newly issued Bristol-Myers Squibb shares and CVRs will commence trading on the New York Stock Exchange, with the CVRs trading under the symbol "BMYRT."

"This is an exciting day for Bristol-Myers Squibb as we bring together the leading science, innovative medicines and incredible talent of Bristol-Myers Squibb and Celgene to create a leading biopharma company," said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb. "With our leading franchises in oncology, hematology, immunology and cardiovascular disease, and one of the most diverse and promising pipelines in the industry, I know we will deliver on our vision of transforming patients’ lives through science. I am excited about the opportunities for our current employees and the new colleagues that we welcome to the Company as we work together to deliver innovative medicines to patients."

Since announcing the transaction on January 3, 2019, there have been a number of tangible advancements toward delivering on the key value drivers for the merger, including: further progress relating to the patent estate for REVLIMID, the U.S. Food and Drug Administration (FDA) approval of INREBIC (fedratinib) for the treatment of certain forms of myelofibrosis, the U.S. FDA approval of REBLOZYL (luspatercept-aamt) for the treatment of anemia in certain adult patients with beta thalassemia, and regulatory filings of luspatercept and ozanimod in the U.S. and Europe. The Company has also made substantial progress toward the planning of a successful integration. For an overview of the combined company and the milestones achieved while the transaction was pending, visit www.bestofbiopharma.com.

OTEZLA Divestiture Update

As announced on August 26, 2019, in connection with the regulatory approval process for the transaction, Celgene entered into an agreement to divest the global rights to OTEZLA (apremilast) to Amgen (NASDAQ:AMGN) for $13.4 billion in cash following the closing of the merger with Bristol-Myers Squibb. On November 15, 2019, Bristol-Myers Squibb announced that the U.S. Federal Trade Commission (FTC) accepted the proposed consent order in connection with the pending merger of Bristol-Myers Squibb and Celgene, thereby permitting the parties to close the merger. Bristol-Myers Squibb expects the OTEZLA divestiture to be completed promptly following the closing of the merger and plans to prioritize the use of proceeds for debt reduction.

Accelerated Share Repurchase Program

Bristol-Myers Squibb also announced that its Board of Directors has authorized the repurchase of $7 billion of Bristol-Myers Squibb common stock.

In connection with this authorization, Bristol-Myers Squibb has entered into accelerated share repurchase (ASR) agreements with Morgan Stanley & Co. LLC and Barclays Bank PLC to repurchase, in aggregate, $7 billion of Bristol-Myers Squibb common stock. Bristol-Myers Squibb expects to fund the repurchase with cash on-hand. Approximately 80 percent of the shares to be repurchased under the transaction will be received by Bristol-Myers Squibb on November 27, 2019. The total number of shares ultimately repurchased under the program will be determined upon final settlement and will be based on a discount to the volume-weighted average price of Bristol-Myers Squibb’s common stock during the ASR period. Bristol-Myers Squibb anticipates that all repurchases under the ASR will be completed by the end of the second quarter of 2020.

Board Appointments

As previously announced, in connection with the closing of the transaction, Michael Bonney, Dr. Julia A. Haller and Phyllis Yale have joined the Bristol-Myers Squibb Board of Directors, expanding the size of the Board from 11 to 14. Mr. Bonney and Dr. Haller served on Celgene’s Board of Directors until the closing of the transaction. All three new directors bring valuable skill sets and significant experience relevant to Bristol-Myers Squibb’s business.

Advisors

Morgan Stanley & Co. LLC is serving as lead financial advisor to Bristol-Myers Squibb, and Evercore and Dyal Co. LLC are serving as financial advisors to Bristol-Myers Squibb. Kirkland & Ellis LLP is serving as Bristol-Myers Squibb’s legal counsel. J.P. Morgan Securities LLC is serving as lead financial advisor and Citi is acting as financial advisor to Celgene. Wachtell, Lipton, Rosen & Katz is serving as legal counsel to Celgene.

On November 20, 2019 Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, reported that it has dosed the first patient in its Phase 1/1b study of PMD-026, the company’s lead product candidate (Press release, PhoenixMD, NOV 20, 2019, View Source [SID1234551545]). PMD-026 is a proprietary first-in-class orally-available RSK (kinase) inhibitor for the potential treatment of patients with metastatic breast cancer and, more specifically, triple-negative breast cancer (TNBC).

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"Dosing the first patient in this newly initiated clinical trial is a paramount milestone for PhoenixMD," said Andrew Dorr, M.D., chief medical officer of Phoenix Molecular Designs. "We believe PMD-026 to be a promising new approach to treat advanced breast cancer and we look forward to building upon this momentum in the pursuit of a potential treatment option for individuals living with advanced forms of breast cancer."

The company’s Phase 1/1b clinical trial will be conducted at leading medical centers across United States and it will evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of PMD-026 in patients with metastatic breast cancer in the dose escalation as well as in women with TNBC in Phase 1b. Importantly, this trial will include a CAP/CLIA (College of American Pathologists/Clinical Laboratory Improvement Amendments) certified companion diagnostic (CDx) designed to detect RSK2 activation in breast tumors and to then correlate it with response to PMD-026. Activated RSK2 is prevalent in breast cancer as it is highly expressed in 89 percent of primary tumors and is found in metastatic disease. In TNBC, early data indicates that approximately 42 percent of patients have extremely high levels of RSK2 activation. Targeting of RSK2, which drives breast cancer proliferation, by PMD-026 creates a distinct precision medicine approach to treating breast cancer.

"Metastatic breast cancer, including TNBC, is a devastating disease with poor prognosis and few impactful treatment options," said Murali Beeram, M.D., lead investigator of South Texas Accelerated Research Therapeutics (START). "Our team is eager to evaluate RSK2 inhibition in advanced breast cancers and play an integral role, alongside PhoenixMD, in the exploration of new medicines for patients."

About PMD-026
PhoenixMD’s lead candidate, PMD-026, is the first RSK inhibitor being developed for the treatment of TNBC. PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase, out of 519 kinases, that drives the growth of this breast cancer subtype. Preclinical data shows the potential for PMD-026 to be effective alone or in combination with conventional chemotherapies. It has the potential to be a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitization for a wide range of refractory cancers in the future. PMD-026 is currently in Phase 1/1b testing.

On November 20, 2019 XOMA Corporation (Nasdaq: XOMA) ("XOMA" or the "Company") reported its intent to commence a rights offering pursuant to which the Company would raise approximately $22 million through the distribution of subscription rights to holders of its common stock ("Common Stock"), Series X preferred stock ("Series X Preferred") and Series Y preferred stock ("Series Y Preferred"), which will entitle the holders to purchase shares of XOMA’s Common Stock at $22.00 per share (the "Rights Offering") (Press release, Xoma, NOV 20, 2019, View Source [SID1234551514]). The Rights Offering will be fully backstopped by BVF Partners L.P., the Company’s largest stockholder, or its assignee/transferee, which has agreed to purchase at a minimum its as-converted pro rata share of the offering amount, plus an additional amount of securities that are not subscribed for by other purchasers in the Rights Offering for a total of up to $22 million.

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Under the proposed Rights Offering, the Company plans to distribute non-transferable subscription rights to purchase a portion of a share of Common Stock for each share of Common Stock outstanding and for each share of Common Stock issuable upon conversion of the Company’s outstanding shares of Series X Preferred and Series Y Preferred, at a subscription price per share of $22.00, to its stockholders of record as of the close of business on November 29, 2019 (the "Record Date"). The subscription rights will be exercisable for an aggregate of 1,000,000 shares of Common Stock, with participation to be allocated among holders of its Common Stock, Series X Preferred and Series Y Preferred on a pro rata basis (assuming full conversion of the Series X Preferred and Series Y Preferred into shares of Common Stock), subject to the aggregate offering threshold and ownership limitations. The subscription rights are non-transferable and may be exercised only during the anticipated subscription period of Monday, December 2, 2019, through 5:00 PM EDT on Wednesday, December 18, 2019, unless extended. Any participant in the Rights Offering that, by exercise of its subscription right would become a holder of greater than 9.9% of the outstanding number of shares of Common Stock of the Company following the Rights Offering may elect to instead purchase Series Z Preferred Stock ("Series Z Preferred") of the Company. The Company intends to sell the Series Z Preferred at $22,000 per share, and any such holder so electing would have a right to purchase one one-thousandth of a share of Series Z Preferred for each share of Common Stock it had a right to purchase under the subscription rights. Each share of Series Z Preferred will, subject to certain limitations, be convertible into 1,000 shares of Common Stock at the election of the holder. The Series Z Preferred will generally have no voting rights, except as required by law, and will participate pari passu, on an as-converted basis, with any distribution of proceeds to holders of Common Stock in the event of the Company’s liquidation, dissolution or winding up.

The Rights Offering will be made pursuant to the Company’s effective shelf registration statement on file with the Securities and Exchange Commission and only by means of a prospectus supplement and accompanying prospectus. The Company expects to mail subscription certificates evidencing the subscription rights and a copy of the prospectus supplement and accompanying prospectus for the Rights Offering shortly following the Record Date.

This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities in any jurisdiction, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

BVF Partners L.P., the Company’s largest shareholder, currently owning approximately 20.5% of the Company’s outstanding Common Stock (and 53.6% on an as-converted basis), will backstop the Rights Offering and has agreed to purchase up to $22 million of Common Stock at a subscription price per share of $22.00, subject to approval by Nasdaq, or Series Z Preferred at a price of $22,000 per share in a private placement promptly at the conclusion of the Rights Offering, with the dollar amount to be purchased in such private placement reduced by the dollar amount sold by the Company (including to BVF Partners L.P., and its affiliates) in the Rights Offering.

On November 20, 2019 Celgene Corporation (NASDAQ: CELG) reported that following the completion of Celgene’s acquisition by Bristol-Myers Squibb Company (NYSE: BMY), Bristol-Myers Squibb and Celgene plan to transfer the listing of Celgene’s contingent value rights (NASDAQ: CELGZ) ("Celgene CVRs") that are related to Celgene’s ABRAXANE product from the NASDAQ Global Market to the New York Stock Exchange ("NYSE") (Press release, Celgene, NOV 20, 2019, View Source [SID1234551530]). As a result, Celgene notified the NASDAQ Global Market today of its intent to initiate the voluntary delisting of the Celgene CVRs. The Celgene CVRs are expected to begin trading on the NYSE under the symbol "CELGRT" following their official delisting from the NASDAQ Global Market, which is expected to occur on December 2, 2019.

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