On November 18, 2019, Halozyme Therapeutics, Inc. (the "Company," "we," "us" or "our") reported that completed its sale of $400.0 million in aggregate principal amount of 1.25% Convertible Senior Notes due 2024 (the " Convertible Notes") in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Filing, 8-K, Halozyme, NOV 18, 2019, View Source [SID1234551418]). The Convertible Notes were issued under an indenture, dated as of November 18, 2019, (the "Indenture") between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee (the "Trustee"). In addition, the initial purchasers of the Convertible Notes (the "Initial Purchasers") exercised their option to purchase an additional $60.0 million in aggregate principal amount of the Convertible Notes. The offer and sale of the Convertible Notes and the shares of common stock issuable upon conversion of the Convertible Notes have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and the Convertible Notes and such shares may not be offered or sold absent registration or an applicable exemption from registration requirements, or in a transaction not subject to, such registration requirements.

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The Company received net proceeds from the offering of approximately $446.9 million. The Company plans to use up to $200.0 million of the net proceeds from the offering to repurchase shares of the Company’s common stock, including approximately $143.1 million to repurchase approximately 8.1 million shares of its common stock concurrently with the offering in privately negotiated transactions effected through one or more of the Initial Purchasers or an affiliate thereof and $50 million to repurchase approximately 2.1 million shares of its common stock, pursuant to and subject to adjustment as provided in the ASR Agreement as described below.

The Company used approximately $26.1 million of the net proceeds from the offering to repay all outstanding amounts under its loan agreement with Oxford Finance and Silicon Valley Bank and intends to use the remainder of the net proceeds for general corporate purposes, including additional share repurchases subsequent to the offering and working capital.

The Convertible Notes will pay interest semi-annually in arrears on June 1st and December 1st of each year, beginning on June 1, 2020, at an annual rate of 1.25% and will be convertible into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election, based on the applicable conversion rate at such time. The Convertible Notes are general unsecured obligations of the Company and will rank senior in right of payment to all of the Company’s indebtedness that is expressly subordinated in right of payment to the Convertible Notes, will rank equally in right of payment with all of the Company’s existing and future liabilities that are not so subordinated, will be effectively junior to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness and will be structurally subordinated to all indebtedness and other liabilities (including trade payables) of the Company’s current or future subsidiaries.

Holders may convert their Convertible Notes at their option only in the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on March 31, 2020, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for each of at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five consecutive business days immediately after any five consecutive trading day period (such five consecutive trading day period, the "measurement period") in which the trading price per $1,000 principal amount of notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of Company’s common stock on such trading day and the conversion rate on such trading day; (3) upon the occurrence of certain corporate events or distributions on Company’s common stock, as described in the offering memorandum; (4) if we call such notes for redemption; and (5) at any time from, and including, June 1, 2024 until the close of business on the scheduled trading day immediately before the maturity date. The Convertible Notes will be convertible, regardless of the foregoing circumstances, at any time from, and including, June 1, 2024 until the close of business on the scheduled trading day immediately preceding the maturity date.

Upon conversion, the Company will pay or deliver, as applicable, cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. The initial conversion rate for the Convertible Notes will be 41.9208 shares of common stock per $1,000 in principal amount of Convertible Notes, equivalent to a conversion price of approximately $23.85 per share of our common stock. The conversion rate is subject to adjustment as described in the Indenture.

Subject to certain exceptions, holders may require the Company to repurchase, for cash, all or any portion thereof in an authorized denomination of their Convertible Notes upon a "Fundamental Change" (as defined in the Indenture) at a price equal to 100% of the principal amount of the Convertible Notes being repurchased plus any accrued and unpaid interest, if any, up to, but excluding, the "Fundamental Change Repurchase Date" (as

defined in the Indenture). In addition, upon a "Make-Whole Fundamental Change" (as defined in the Indenture) prior to the maturity date of the Convertible Notes, the Company will, in certain circumstances, increase the conversion rate for a specified period of time. The Company may not redeem the Convertible Notes prior to December 1, 2022 and on or before the 40th scheduled trading day immediately before the maturity date.

The Indenture includes customary covenants, and sets forth certain events of default after which the Convertible Notes may be declared immediately due and payable and sets forth certain types of bankruptcy or insolvency events of default involving the Company or certain of its subsidiaries after which the Convertible Notes become automatically due and payable.

The foregoing description of the Indenture and Convertible Notes is qualified in its entirety by reference to the text of the Indenture and the Form of Convertible Note, copies of which are attached as Exhibits 4.1 and 4.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

On November 18, 2019 FUJIFILM Corporation (President: Kenji Sukeno) reported the start of a U.S. Phase I clinical trial of FF-10850, an anti-cancer agent targeting advanced solid tumors (Press release, Fujifilm, NOV 18, 2019, View Source [SID1234551417]). FF-10850 is a liposome-based agent in which topotecan*1, an approved anti-cancer agent, has been encapsulated in the newly developed liposome. The study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of FF-10850.

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As a drug delivery system (DDS), liposomes are artificially constructed vesicles made from the organic phospholipids which make up cellular membranes and biomembranes. Liposomes can deliver the required amount of a drug to the specific area of the body on predetermined schedule. Anti-cancer agents can act on normal cells, in addition to cancer which can induce strong adverse reactions. By encapsulating a drug in liposomes it is expected to selectively deliver the drug to cancer cells, suppress adverse reactions, and improve pharmacological efficacy.

FF-10850 is a liposome formulation with the purpose of delivering anti-cancer agent to cancerous cells, with the aim of reducing bone marrow suppression*2 and other adverse reactions of topotecan indicated for the treatment of ovarian cancer, etc., and to improve pharmacological efficacy. In the past, liposome encapsulation of topotecan was ineffective because the drug would leak from the liposome prior to reaching the cancerous area. By adding new materials to liposome ingredients and enhancing the strength of the liposome membrane, Fujifilm solved the challenges associated with drug delivery and in preclinical studies it successfully encapsulated topotecan in a stable manner for FF-10850.

Preclinical studies of FF-10850 in mice have shown stable encapsulation of Topotecan in the blood and reduced bone marrow suppression when compared with using Topotecan alone. The study also showed improved efficacy of FF-10850 (3 mg/m2) when compared to Topotecan (30 mg/m2) alone – demonstrating that FF-10850 can have the equivalent effect of Topetcan at just 1/10th the dose. Furthermore, the study showed that FF-10850 (8 mg/m2) demonstrated tumor regression.

Fujifilm has actively promoted the research and development of liposome formulations by harnessing its advanced nano-dispersion technology, analysis technology, and process technology cultivated and evolved through its wide range of product development. In 2017, the company began a U.S. Phase I clinical trial of FF-10832, a liposome-based agent that encapsulates the approved anti-cancer agent gemcitabine*3.

In the preclinical mice studies on FF-10850 and FF-10832*4 Fujifilm has observed the extension of the survival period as a result of immune checkpoint inhibitor*5 combination therapy. In addition, Fujifilm has been promoting the application of liposome for use with next-generation drugs such as nucleic acid drugs and gene therapy drugs. Looking towards future growth, in order to ensure a stable supply of high-quality liposome formulations, Fujifilm is developing a manufacturing facility for producing investigational and commercial drugs through its subsidiary, FUJIFILM Toyama Chemical Co., Ltd. The facility is planned to begin operations in February 2020.

Fujifilm is harnessing its unique technologies to undertake the development of new drugs in the priority areas including oncology. The company is also focusing on developing DDS technologies to create new value and contributing to the resolution of social issues.

*1: An anti-cancer agent (generic name: topotecan, product name: Hycamtin) developed by GlaxoSmithKline plc. Currently, the drug is being sold by Novartis. It is used as a treatment for ovarian cancer, small-cell lung cancer, cervical cancer, etc.

*2: Because of the adverse reaction of anti-cancer agents, the functions of bone marrow are suppressed, and the production of white blood cells, platelets, and red blood cells is reduced, leading to increased risk of infection, bleeding and anemia. With topotecan, severe bone marrow suppression is seen in over 80% of the patients.

*3: An anti-cancer drug (generic name: gemcitabine, product name: Gemzar) developed by Eli Lilly and Company. It is used as the first-line drug for the treatment of pancreatic cancer, and is also indicated for the treatment of a wide range of other cancers (such as lung cancer and ovarian cancer).

*4: The results on preclinical studies on FF-10850 and FF-10832 were presented at 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) SYMPOSIUM

*5: A general term for drugs that demonstrate an efficacy by enabling immune cells to attack cancer cells by inhibiting the immune suppressive mechanisms (immune checkpoints). They are widely used in the treatment of malignant melanomas, lung cancer, stomach cancer, kidney cancer, etc.

On November 18, 2019 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, reported that Forbius management will present a company overview at the Jefferies 2019 Healthcare Conference on Thursday, November 21, 2019 at 07:20 a.m. GMT in London (Press release, Forbius, NOV 18, 2019, View Source [SID1234551416]).

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On November 18, 2019 GenScript Biologics, a world leading bio-pharmaceutical CDMO company, reported that it entered into an agreement with ABL Bio Inc., a South Korean biotech company dedicated to therapeutics for immuno-oncology and neurodegenerative diseases (Press release, GenScript, NOV 18, 2019, View Source;genscript-biotech-corp-bispecific-antibody-strategic-partnership-agreement-ceremony-300959738.html [SID1234551415]). The parties have reached a partnership for two bispecific antibody programs.

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According to the license agreement, GenScript will grant a sublicense to ABL Bio to use sdAb (single-domain antibody), mAb (monoclonal antibody) targeting tumor antigens, and its Single-Domain Antibody fused to Monoclonal Ab (SMAB) Platform to develop several bispecific antibody molecules. ABL Bio will appoint GenScript as the exclusive supplier of CDMO services for IND-enabling studies and clinical material manufacturing so as to accelerate the development of the bispecific antibody under the licensing agreement. GenScript will consistently provide support and services for the programs. GenScript will receive an upfront with milestone payments, and royalty. The parties will make full use of their own advantages and resources to further expand ABL Bio’s bispecific antibody development pipelines and strengthen ABL Bio’s global leading position in cancer research.

"We are glad to cooperate with GenScript. GenScript is growing fast in recent years and has facilitated several companies to make achievements in antibody drug research," said Dr. Sang Hoon Lee, CEO of ABL Bio at the signing ceremony, "We expect the outstanding druggability and streamlined production processes of GenScript’s SMAB platform to accelerate the development of novel immunotherapy and the launch of new drugs. This partnership will further expand our bispecific antibody development pipelines, and help us ascend to a leader in therapeutics for immuno-oncology and neurodegenerative diseases."

"We are excited about this collaboration with ABL Bio, an experienced company in the bispecific antibody field, which manifests that GenScript’s biologics R&D services have been increasingly recognized by global well-known enterprises," Dr. Brian Min, CEO of GenScript Biologics, said, "GenScript has extensive experience and powerful teams in biologics R&D. We would like to cooperate with more well-positioned enterprises like ABL Bio, utilize our own powerful R&D advantages, and accelerate the development of novel antibody drugs."

On November 18, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the completion of an underwritten public offering of 43,620,690 shares of its common stock, including 5,689,655 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares (Press release, BioCryst Pharmaceuticals, NOV 18, 2019, View Source [SID1234551414]). The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters’ option to purchase additional shares, were approximately $63.3 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst.

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BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for the prophylactic BCX7353 program, primarily focusing on the U.S., EU and Japan; development of the BCX9930 program; development of the BCX9250 program; post-approval commitments for RAPIVAB/ALPIVABTM; funding clinical development of pipeline assets; and capital expenditures and other general corporate expenses.

J.P. Morgan acted as sole book-running manager for the offering. JMP Securities and H.C. Wainwright & Co. acted as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering was made by means of a prospectus supplement and related prospectus. A prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204.