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Stemline Therapeutics Highlights Three ELZONRIS Presentations, Including an Oral Presentation in Myelofibrosis, at Upcoming ASH Meeting

On December 6, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that highlighted three upcoming ELZONRIS (tagraxofusp), presentations, including an oral presentation of ELZONRIS clinical data in myelofibrosis, at this year’s American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, that is being held from December 7-10 in Orlando, FL (Press release, Stemline Therapeutics, DEC 6, 2019, View Source [SID1234551990]).

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Details on the ASH (Free ASH Whitepaper) presentations are as follows:

Myelofibrosis – ELZONRIS monotherapy, clinical; oral presentation
Title: Results from a Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Intermediate, or High Risk, Relapsed/Refractory Myelofibrosis
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 558
Session: 634. Myeloproliferative Syndromes: Clinical: Emerging and Novel Targeted Therapies
Date/Time: Monday, December 9, 2019 8:15 AM ET
Location: Orange County Convention Center, W304EFGH

Multiple Myeloma – ELZONRIS in combination with Pom+Dex, clinical; poster presentation
Title: Results from Phase 1/2 Trial of Tagraxofusp in Combination with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Presenter: Paul G. Richardson, M.D.; Dana-Farber Cancer Institute
Abstract: 3145
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date/Time: Sunday, December 8, 2019 6:00 PM–8:00 PM ET
Location: Orange County Convention Center, Hall B

Myeloproliferative Neoplasms – ELZONRIS in combination with ruxolitinib, preclinical; poster presentation
Title: Evaluation of Tagraxofusp (SL-401) Alone and in Combination with Ruxolitinib for the Treatment of Myeloproliferative Neoplasms
Presenter: Aishwarya Krishnan, MD; Memorial Sloan Kettering Cancer Center
Abstract: 2967
Session: 635. Myeloproliferative Syndromes: Basic Science: Poster II
Date/Time: Sunday, December 8, 2019 6:00 PM–8:00 PM ET
Location: Orange County Convention Center, Hall B

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

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

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

MSD and Taiho Pharmaceutical terminate co-promotion contract for anti-PD-1 antibody/anti-cancer drug KEYTRUDA® In Japan

On December 6, 2019 MSD K.K. (president and CEO Jannie Oosthuizen, Chiyoda-ku, Tokyo) and Taiho Pharmaceutical Co., Ltd. (president and CEO Masayuki Kobayashi, Chiyoda-ku, Tokyo) reported that they have agreed to terminate their co-promotion contract in Japan at the end of December 2019 for KEYTRUDA (pembrolizumab [genetical recombination]), anti-PD-1 therapy manufactured and marketed by MSD (Press release, Taiho, DEC 6, 2019, View Source [SID1234551969]).

KEYTRUDA was launched on February 15, 2017 and has been co-promoted by MSD and Taiho Pharmaceutical in Japan. From January 2020, MSD will continue manufacturing, distribution and promotion of KEYTRUDA.

MSD and Taiho Pharmaceutical believe that they could make a significant contribution to patients and healthcare professionals by providing a novel cancer treatment option through the co-promotion activities. The companies will continue their commitment to the advancement in cancer therapy in the course of their business activities.

MSD and Taiho Pharmaceutical terminate co-promotion contract for anti-PD-1 antibody/anti-cancer drug KEYTRUDA® In Japan

Xspray Pharma has carried out a directed share issue raising gross proceeds of approximately SEK 122 million

On December 5, 2019 Xspray Pharma reported the company has successfully carried out a directed share issue at a subscription price of SEK 73 per share (the "Issue") (Press release, Xspray, DEC 5, 2019, View Source [SID1234650106]). The subscription price is in line with the volume-weighted average price of the Xspray share during the last 30 days. The subscription price has been determined through an accelerated book-building procedure.

A group of Swedish and international institutional investors, among others C WorldWide Asset Management, Fourth Swedish National Pension Fund, Swedbank Robur, TIN Fonder, Third Swedish National Pension Fund and Unionen have subscribed for shares in the Issue. The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate transaction structure at this time in order to raise capital for the development of ongoing projects in a time and cost-effective manner. Moreover, through the Issue, the Company will further strengthen the shareholder base with institutional investors.

The Company intends to use the net proceeds from the Issue to:

enhance the Company’s financial flexibility ahead of anticipated registration application of its lead product, HyNap-Dasa, in 2020 and anticipated deal making pertaining to the launch of this candidate;
establish second source manufacturing;
working capital requirement at expected listing on Nasdaq Stockholm’s Main Market during the first half of 2020;
continue to expand its product portfolio;
general corporate purposes.
The Issue is expected to raise proceeds for the Company of approximately SEK 122 million before transaction costs. The subscription price has been determined through an accelerated book-building procedure. The Issue will result in an increase in the number of shares in Xspray of 1,675,162, from 15,076,460 to 16,751,622, and an increase in the share capital by SEK 1,675,162, from SEK 15,076,460 to SEK 16,751,622, resulting in a dilution of approximately 10 percent.

In connection with the Issue, the Company has, with customary exceptions, agreed to a lock-up undertaking on future share issuances for a period of 90 days after the Issue. In addition, the management and Board of Directors have undertaken not to sell any shares in Xspray during the same period, subject to customary exceptions.

The reason for using the flexibility provided by a non-pre-emptive placing is to raise capital for the development of ongoing projectsand to further strengthen the Company’s shareholder base in a time and cost-effective manner.

BiocurePharm, Korea (“BPK”) Announces Closing of Convertible Debenture Financing

On December 5, 2019 BiocurePharm, Korea ("BPK"), a wholly owned subsidiary of Biocure Technology Corp. (CSE: CURE) (OTCQB: BICTF) ("CURE" or the "Company") reported that it has closed its Convertible Debenture financing. BPK has issued convertible debentures for gross proceeds of Korean Won660,000,000 (CAD732,600) (Press release, Biocure Technology, DEC 5, 2019, View Source [SID1234628753]). Its maturity date is December 5, 2029, with the coupon rate of 3%. The investor has a right to convert to common shares of BPK at CAD12.21 per share three years after the issuance of Convertible Debenture. All dollar values are based on the published Exchange Rate of CAD0.001110/KRW1 on December 4, 2019, Bank of Canada.