X4 Pharmaceuticals to Present Clinical Data from Phase 2 Study of X4P-001-RD in WHIM Syndrome

On May 17, 2018 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking to treat cancer and rare disease, reported that an abstract highlighting X4P-001-RD, the company’s CXCR4 antagonist, has been selected for poster presentation at the 23rd Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), taking place June 14-17 in Stockholm, Sweden (Press release, X4 Pharmaceuticals, MAY 17, 2018, View Source [SID1234526787]). The presentation will describe interim clinical results from the ongoing Phase 2/3 study of X4P-001-RD in patients with WHIM syndrome, a rare genetic, primary immunodeficiency disease.

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X4 Pharmaceuticals will present clinical data from a PH2 study of X4P-001-RD in WHIM syndrome at the annual European Hematology Assoc. meeting #EHA23

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Details of the presentation on X4P-001-RD in WHIM syndrome are as follows:

Title: Phase 2 Study of X4P-001: A Targeted Oral Therapy for Patients with WHIM Syndrome

Author: David Dale, M.D., University of Washington

Abstract #: PS1056

Poster Session: Bone marrow failure syndromes incl. PNH – Clinical

Date and Time: Saturday, June 16, 5:30-7:00 p.m. CEST

About WHIM Syndrome

WHIM syndrome is a primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene resulting in susceptibility to certain types of infections. WHIM is an abbreviation for the characteristic clinical symptoms of the syndrome: Warts, Hypogammaglobulinemia, Infections, and Myelokathexis. Within the overall category of primary immunodeficiencies, there are between 15,000 and 100,000 patients in the US that are classified with primary immunodeficiency disease of unknown origin – of which WHIM is one.1,2,3 WHIM syndrome is a rare disorder and the precise prevalence or incidence of patients that have the genetic mutation responsible for WHIM syndrome is unknown. Because patients are highly susceptible to infections, WHIM syndrome is associated with significant morbidity beginning in early childhood and continuing throughout life. Current therapy is limited to treatment of acute infections with antibiotics or prevention through the use of intravenous immunoglobulin or G-CSF. There is no approved therapy for the treatment of WHIM syndrome.

Celyad announces pricing of $47.3 million global offering

On May 17, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell based therapies, reported the pricing of a global offering of 1,800,000 ordinary shares, comprised of 523,913 ordinary shares in the form of American Depositary Shares (ADSs) offered in the United States, Canada and certain countries outside of Europe at a price per ADS of $26.28, and 1,276,087 ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement at a price per share of €22.29 (the "global offering") (Press release, Celyad, MAY 17, 2018, View Source [SID1234532516]). Each ADS represents the right to receive one ordinary share. The price per ADS was determined based on an exchange rate of $1.1789 per euro. The gross proceeds to Celyad from the global offering are expected to be approximately $47.3million (approximately €40.1 million), before deducting underwriting commissions and estimated offering expenses.
In addition, Celyad has granted the underwriters a 30-day option to purchase up to an additional 270,000 ordinary shares, which may be in the form of ADSs, on the same terms and conditions. The closing of the global offering is expected to occur on May 22, 2018, and is subject to customary closing conditions.

Celyad’s ADSs are currently listed on the NASDAQ Global Select Market under the symbol "CYAD" and Celyad’s ordinary shares are currently listed on Euronext Brussels and Euronext Paris.

Wells Fargo Securities, LLC and Bryan, Garnier & Co. are acting as joint bookrunning managers for the offering. Bank Degroof Petercam NV is acting as a co-manager for the private placement and LifeSci Capital LLC is acting as a co-manager for the global offering. Kempen & Co NV is Celyad’s advisor in connection with the offering.

The securities are being offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement dated May 15, 2018 relating to and describing the terms of the offering was filed with the SEC on May 16, 2018. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to these securities can also be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, at (800) 326-5897 or email a request to [email protected] or Bryan, Garnier & Co., Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at [email protected].

This press release does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale is or would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

DelMar Pharmaceuticals Announces Third Quarter Fiscal Year 2018 Financial Results

On May 17, 2018 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported its financial results for the third quarter ended March 31, 2018 (Press release, DelMar Pharmaceuticals, MAY 17, 2018, View Source [SID1234526736]). DelMar executive management will host a business update conference call for investors, analysts and other interested parties on May 30, 2018 at 4:30 p.m. Eastern Time.

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"This quarter has been a pivotal and important period for DelMar. I am pleased with our enhanced focus on leveraging VAL-083’s unique mechanism of action to advance both of our Phase 2 clinical programs including MGMT-unmethylated, second-line, bevacizumab (Avastin) naïve glioblastoma, and MGMT-unmethylated, first-line, temozolomide-naïve glioblastoma. MGMT methylation status has become increasingly important in the diagnosis and treatment of glioblastoma, and a routine part of clinical practice as it is a well-established biomarker that correlates with resistance to the standard-of-care chemotherapy, temozolomide, and with patient outcomes. We believe that using this biomarker will optimize patient selection for treatment in future trials with our lead drug candidate, VAL-083, thereby streamlining development and enhancing opportunities for success in our clinical development programs," commented Saiid Zarrabian, Interim President and Chief Executive Officer.

KEY HIGHLIGHTS

Continued enrolling patients in the Company’s Phase 2, open-label, second-line Avastin-naïve, MGMT-unmethylated, recurrent glioblastoma multiforme (GBM) trial being conducted at the MD Anderson Cancer Center

·Increased patient enrollment rate of the Phase 2, open-label, first-line temozolomide-naïve, MGMT-unmethylated GBM trial at Sun Yat-sen University Cancer Center

Presented a positive interim update from ongoing open-label Phase 2 clinical trials in MGMT-unmethylated GBM at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) held in April, 2018

·Presented promising pre-clinical results supporting the potential of VAL-083 in the treatment of cancer patients whose tumors exhibit features that make them resistant to, or unlikely to respond to, currently available therapies at the Annual Meeting of AACR (Free AACR Whitepaper) held in April, 2018

·Presented promising pre-clinical data supporting the potential of VAL-083 as part of second- line combination treatment with Avastin for GBM at the biennial Canadian Neuro-Oncology meeting in May 2018

Ramped-up evaluation of improved development strategies for VAL-083’s ovarian program, including specific biomarkers for optimal VAL-083 efficacy and combination treatment with PARP inhibitors, utilizing our newly formed clinical advisory board

·Based on overall clinical and corporate development progress achieved to date, we expect to have cash available to fund planned operations into the third quarter of calendar 2019

For further details on the Company’s operating and financial results, as well as more detail about its updated strategy, refer to DelMar’s 10-Q filed with the SEC on May 15, 2018, View Source

CONFERENCE CALL DETAILS

DelMar plans to host a conference call to discuss its financial results for the quarter ended March 31, 2018 and provide a corporate update on May 30, 2018, at 4:30 p.m. Eastern Time. For both "listen-only" participants and those who wish to take part in the question and answer portion of the call, the telephone Dial-in Number is 1 877-876-9176 (toll free) with Conference ID DELMAR.

A replay of the conference call will be available on the IR Calendar of the Investors section of the Company’s website at www.delmarpharma.com and will be archived for 30 days.

SUMMARY OF FINANCIAL RESULTS FOR THE PERIOD ENDED MARCH 31, 2018

At March 31, 2018, the Company had combined cash and cash equivalents and clinical trial deposits on hand of approximately $9.4 million.

For the three months ended March 31, 2018, the Company reported a net loss of $2,933,057 or $0.13 per share, compared to a net loss of $1,868,460, or $0.18 per share, for the three months ended March 31, 2017. For the nine months ended March 31, 2018, the Company reported a net loss of $8,761,061 or $0.44 per share, compared to a net loss of $5,480,772, or $0.54 per share, for the nine months ended March 31, 2017.

The following represents selected financial information as of March 31, 2018. The Company’s financial information has been prepared in accordance with U.S. GAAP and this selected information should be read in conjunction with DelMar’s consolidated financial statements and management’s discussion and analysis ("MD&A"), as filed.

Aptose to Present New CG’806 Data at the 23rd Congress of the European Hematology Association

On May 17, 2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that new preclinical data for CG’806, its pan-FLT3/pan-BTK inhibitor, will be presented in a poster presentation at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), taking place June 14-17, 2018 in Stockholm, Sweden (Press release, Aptose Biosciences, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349693 [SID1234526754]).

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CG’806 Poster Presentation Details:

CG’806, A NON-COVALENT PAN-FLT3/PAN-BTK INHIBITOR, EXHIBITS UNIQUE BINDING TO WILD TYPE AND C481S MUTANT BTK AND GREATER POTENCY THAN IBRUTINIB AGAINST MALIGNANT B CELLS

Date & Time: Friday, June 15 2018, 5:30 p.m. – 7:30 p.m. CEST
Session Title: Chronic lymphocytic leukemia and related disorders – Biology & Translational Research
Abstract Number: PF337
Location: Poster area, Stockholmsmässan: Mässvägen 1, 125 80 Älvsjö, Sweden

The accepted abstract is available online on the EHA (Free EHA Whitepaper) conference website (click here).

About CG’806
CG‘806 is an oral, first-in-class pan-FLT3/pan-BTK multi-kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG’806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG’806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors.

MorphoSys Announces Presentation of Clinical Data on Proprietary Blood Cancer Programs at Upcoming EHA 2018 Conference

On May 17, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX; Nasdaq: MOR; OTC: MPSYY) reported the publication of two abstracts on its proprietary hemato-oncological drug candidates MOR208 and MOR202 submitted to the 23rd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting, to be held in Stockholm/Sweden from June 14-17, 2018 (Press release, MorphoSys, MAY 17, 2018, View Source [SID1234526772]).

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In a poster presentation, first clinical data from the exploratory phase 2 COSMOS trial with the Fc-engineered CD19 antibody MOR208 in combination with idelalisib in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), after discontinuation of an ibrutinib therapy, will be presented. In an oral presentation, updated maturing data from a phase 1/2a study with the CD38 antibody MOR202 alone and in combination with pomalidomide or lenalidomide in relapsed/refractory multiple myeloma will be presented.

"We are pleased that clinical data from trials investigating our proprietary antibody programs MOR208 and MOR202 in indications with high medical need were selected for presentation at the upcoming EHA (Free EHA Whitepaper) conference," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG.

Details about the abstracts from MorphoSys’s proprietary programs MOR208 and MOR202 accepted for presentation at EHA (Free EHA Whitepaper) 2018:

Abstract Code: PF350

Two-cohort, phase II study in R/R CLL (COSMOS): First preliminary safety and efficacy results of MOR208 treatment in combination with idelalisib in patients who discontinued prior ibrutinib therapy

The poster presentation will include clinical results from the phase 2 study COSMOS with MOR208 in combination with idelalisib (cohort A) in adult patients with relapsed/refractory CLL who failed prior treatment with Bruton’s Tyrosine Kinase inhibitor (BTKi) ibrutinib.

The poster will be presented during the session "Chronic lymphocytic leukemia and related disorders – Clinical" on Friday, June 15, 2018 5:30-7:00 pm CEST (11:30am-1:00pm EDT), in the poster area at the Stockholmsmässan in Stockholm.

In addition, the abstract will be on display on the E-poster screens at the conference from Friday, June 15, 2018, 9:30 am CEST (3:30 am EDT) to Sunday, June 17, 2018 1:00 pm CEST (7:00 am EDT).

Abstract Code: S848

MOR202 with low-dose dexamethasone (DEX) or pomalidomide/DEX or lenalidomide/DEX in relapsed or refractory multiple myeloma (r/r MM): A phase I/IIa, multicenter, dose-escalation study

The oral presentation will include updated clinical data from the phase 1/2a study with MOR202 alone or in combination with the immunomodulatory drugs lenalidomide or pomalidomide, plus low-dose dexamethasone (DEX). The trial is being conducted in pre-treated patients with relapsed/refractory multiple myeloma.

The oral presentation will be given during the session "New therapeutic strategies to improve the outcome of relapse/refractory plasma cell disorders" on Saturday, June 16, 2018, from 4:15-4:30pm MEST (10:15-10:30am EDT), in Room A1 at the Stockholmsmässan in Stockholm.

Additional information can be found at www.ehaweb.org, including the abstracts.