On January 18, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its fourth-quarter and full-year 2018 financial results on Wednesday, Feb. 20, 2019 (Press release, Valeant, JAN 18, 2019, View Source [SID1234532780]). Bausch Health will host a conference call and live web cast at 8:00 a.m. EST to discuss the results and provide a business update . All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

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Conference Call Details

Date:

Wednesday, Feb. 20, 2019

Time:

8:00 a.m. EST

Webcast:

View Source

Participant Event Dial-in:

+1 (888) 317-6003 (United States)

+1 (412) 317-6061 (International)

+1 (866) 284-3684 (Canada)

Participant Passcode:

4514727

Replay Dial-in:

+1 (877) 344-7529 (North America)

+1 (412) 317-0088 (International)

+1 (855) 669-9658 (Canada)

Replay Passcode:

10127646 (replay available until Feb. 27, 2019)

On January 18, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing innovative oncology therapeutics, reported the closing of a previously announced underwritten public offering of 10,222,222 shares of its common stock, which included the exercise in full of the option to purchase 1,333,333 additional shares, at a price of $9.00 per share (Press release, Stemline Therapeutics, JAN 18, 2019, View Source [SID1234532779]). The gross proceeds to Stemline from the offering, including the exercise of the option to purchase additional shares, before deducting underwriting discounts, commissions and other offering expenses payable by Stemline, were $92 million.

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J.P. Morgan Securities LLC and Cowen and Company, LLC acted as joint book-running managers for the offering. Cantor Fitzgerald & Co., Ladenburg Thalmann & Co. Inc. and H.C. Wainwright & Co., LLC acted as co-lead managers and Roth Capital Partners, LLC, ThinkEquity, a division of Fordham Financial Management, Inc., A.G.P./Alliance Global Partners, National Securities Corporation, and Aegis Capital Corp. acted as co-managers for the offering.

Stemline intends to use the net proceeds from this offering for (i) commercial activities of ELZONRIS (tagraxofusp; SL‑401) including clinical trials for additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other diseases; (ii) clinical development of SL‑801, SL‑701 and potentially SL-901; (iii) research and development activities; (iv) potential acquisitions and in-licensing; and (v) other general corporate purposes.
Stemline has filed a prospectus supplement to its shelf registration statement on Form S-3 (File No. 333-219794) with the U.S. Securities and Exchange Commission ("SEC") for the public offering of its common stock. The prospectus supplement is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by contacting J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Telephone: (866) 803-9204, or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by email at [email protected].

The offering of these securities was made under an effective shelf registration statement on file with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy 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.

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the marketing authorization application (MAA), which was submitted to the EMA in January 2019. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other diseases

On January 18, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for expanded use of "FoundationOne CDx Cancer Genomic Profile," a next-generation sequencing based program currently under preparation for launch, to include a companion diagnostic for the drug candidate entrectinib (Press release, Chugai, JAN 18, 2019, View Source [SID1234532776]). Entrectinib is currently under regulatory review for the treatment of NTRK fusion-positive solid tumors.

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FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program was approved by the MHLW in December 2018 as the first cancer genomic test in Japan with the two functions of cancer genomic profiling and companion diagnostics for molecular-targeted drugs.

The filing aims to expand the program for use as a companion diagnostic to identify people likely to benefit from entrectinib by detecting NTRK fusion genes (fusion genes between NTRK1, NTRK2, NTRK3 and other genes). Chugai filed a regulatory application for entrectinib to obtain approval for the treatment of very rare NTRK fusion-positive solid tumors in December 2018. The drug was granted both Sakigake designation and orphan drug designation in Japan.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

[Notes]

A press release issued on December 27, 2018: Chugai Obtains Approval for Genomic Mutation Analysis Program "FoundationOne CDx Cancer Genomic Profile"
View Source
A press release issued on December 19, 2018: Chugai Files a New Drug Application for a ROS1/TRK Inhibitor Entrectinib for the Treatment of NTRK Fusion-Positive Solid Tumors
View Source
About FoundationOne CDx Cancer Genomic Profile
FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx Cancer Genomic Profile is intended to be used as a comprehensive companion diagnostic for patients with certain types of cancers to identify those patients that may benefit from approved molecular targeted therapies in Japan.

About entrectinib
Entrectinib is an investigational, oral medicine in development for the treatment of locally advanced or metastatic solid tumors that harbor NTRK1/2/3 or ROS1 gene fusions. It is a selective, CNS-active tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer. Entrectinib can block ROS1 and NTRK kinase activity and inhibit proliferation of cancer cells with ROS1 or NTRK gene fusions. Entrectinib is being investigated across a range of solid tumor types, including breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.

About NTRK fusion gene positive cancer
NTRK fusion gene is an abnormal gene that can be formed by fusing the NTRK genes (NTRK1, NTRK2, NTRK3 encode TRKA, TRKB, TRKC protein, respectively) and other genes (ETV6, LMNA, TPM3, etc.) as a result of chromosomal translocation. The TRK fusion kinase made from NTRK fusion gene is thought to promote cancer cell proliferation. There is very rare expression of NTRK fusion but in various adult and pediatric solid tumors, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, gastrointestinal stromal tumor (GIST), infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas.

On January 18, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that it has entered into a definitive agreement with a single institutional investor to receive gross proceeds of approximately $2.35 million (Press release, Can-Fite BioPharma, JAN 18, 2019, View Source [SID1234532775]).

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In connection with the offering, the Company will issue 2,238,096 registered American Depository Shares (ADSs) of Can-Fite at a purchase price of $1.05 per ADS in a registered direct offering. Additionally, for each ADS purchased by investors, the investors will receive an unregistered warrant to purchase one ADS. The warrants will have an exercise price of $1.30 per ADS, will be immediately exercisable and will expire five and one-half years from the issuance date. The closing of the offering is expected to take place on or about January 23, 2019, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent in connection with this offering.

The ADSs described above (but not the warrants or the ADSs underlying the warrants) are being offered pursuant to a shelf registration statement (File No. 333-220644) which became effective on October 11, 2017. Such ADSs may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company will file a prospectus supplement and the accompanying base prospectus with the SEC relating to such ADSs. When available, copies of the prospectus supplement and the accompanying base prospectus may be obtained at the SEC’s website at View Source, or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by telephone: (646) 975-6996 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction

On January 18, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported the closing of the exclusive, global collaboration and license agreement for cusatuzumab (ARGX-110), a highly differentiated anti-CD70 SIMPLE Antibody, with Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson (Press release, argenx, JAN 18, 2019, View Source [SID1234532774]). The collaboration agreement became effective following expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and the closing of the private placement described below.

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argenx and Janssen have agreed to a joint global clinical development plan to evaluate cusatuzumab in acute myeloid leukemia, myelodysplastic syndromes and other potential future indications. Under the terms of the agreement, Janssen will pay argenx $300 million in an upfront payment. argenx will be eligible to receive potentially up to $1.3 billion in development, regulatory and sales milestones, in addition to tiered, double-digit royalties. Janssen will be responsible for commercialization worldwide. argenx retains the option to participate in commercialization efforts in the US, where the companies have agreed to share economics 50/50 on a royalty basis, and outside the US, Janssen will pay double-digit sales royalties to argenx.

In addition, the private placement of 1,766,899 new argenx shares at a price of €100.02 ($113.19, based on the EUR/USD exchange rate as of December 2, 2018) per share to Johnson & Johnson Innovation Inc. — JJDC, Inc. (JJDC) was completed as part of the closing, with gross proceeds to argenx of €176.7 million (approximately $200 million). argenx’s share capital will be €3,789,576.40 after registration of the capital increase. Following Euronext Brussels’ approval of argenx’s request for the admission to listing and trading of the new shares, it is expected that the new shares will be admitted to trading and official listing on the regulated market of Euronext Brussels on January 23, 2019.

About Cusatuzumab

Cusatuzumab (ARGX-110) is an investigational SIMPLE Antibody targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. Cusatuzumab is designed to: block CD70, kill cancer cells expressing CD70 through complement dependent cytotoxicity, enhanced antibody-dependent cell-mediated phagocytosis and enhanced antibody-dependent cell-mediated cytotoxicity, and restore immune surveillance against solid tumors (Silence K. et al. mAbs 2014; 6 (2):523-532). Cusatuzumab is currently being evaluated in patients with hematological malignancies, including a Phase 1/2 trial in combination with Vidaza in patients with newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes. Recently,

cusatuzumab has been granted orphan drug designation for the treatment of AML by FDA. Preclinical work on cusatuzumab in AML was performed in collaboration with the Tumor Immunology Lab of Prof. A. F. Ochsenbein at the University of Bern, who won, together with Prof. Manz at the University Hospital of Zürich, the prestigious 2016 Otto Naegeli Prize for his breakthrough research on CD70/CD27 signaling with therapeutic potential for cancer patients