On August 25, 2016 argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, reported its second quarter business update and half year financial results for 2016, in accordance with IFRS as adopted by the European Union (Press release, arGEN-X, AUG 25, 2016, View Source [SID:1234514755]).

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The half year results will be discussed during a conference call and webcast presentation today at 3 pm CET / 9 am EDT. To participate in the conference call, please select your phone number below, and use the confirmation code 49998398. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

"This quarter was a seminal one for us as we made substantial progress against several very important corporate goals: advancing our clinical and other pipeline programs and in closing a significant financing with key U.S. institutional investors as well as entering into a strategic transaction with AbbVie for our oncology candidate AGRX-115. We believe these accomplishments have driven argenx forward to become a new and more substantial company with a full and mature clinical pipeline, an advanced platform and the financial and strategic support to derive value from them," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "During the quarter we announced data from our Phase 1 MAD and SAD studies of ARGX-113 which led to the selection of our Phase 2 dose and demonstrated the drug’s strong safety profile and its ability to rapidly reduce IgG levels in healthy volunteers. Our lead oncology candidate ARGX-110 showed further evidence of anti-tumor activity in T-cell lymphoma patients and is on track to announce top-line data in this expansion cohort by end of year. We are looking forward to executing on our strategic plan for the remainder of 2016 to bring ARGX-113 into two Phase 2 indications and to examine the breadth of potential for ARGX-110 as a monotherapy and a combination agent in TCL and AML."

SECOND QUARTER 2016

Announced initial results from its Phase 1 multiple ascending dose (MAD) study of ARGX-113 in healthy volunteers. The compound continues to show favorable safety and tolerability across multiple doses and dosing regimens with promising pharmacodynamics effects relating to speed, depth and duration of IgG reduction.
Published efficacy and safety data from its ARGX-111 Phase 1 expansion study in patients with MET amplified tumors in conjunction with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting (Chicago, USA). The data confirm ARGX-111 to have a favorable safety profile and to continue to show signs of anti-tumor activity.
Presented efficacy and safety data from its Phase 1 expansion study of ARGX-110 in patients with T-cell lymphoma (TCL) during an e-poster session at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress (Copenhagen, Denmark). The data from the Phase 1 expansion study show evidence of clinical and/or biological anti-tumor activity with ARGX-110 in highly refractory cutaneous TCL & peripheral TCL patients with confirmed overexpression of CD70.
Entered into placement agreements with several predominant U.S. institutional investors relating to the issue of a total of 2,703,000 new shares for an aggregate amount of €30,003,300. The transaction was led by MPM Oncology Impact Fund with participation from Aquilo Capital, Burrage Capital, DAFNA Capital, Perceptive Advisors and certain other existing and new institutional investors.
Announced collaboration with AbbVie to develop and commercialize ARGX-115. ARGX-115 is argenx’ preclinical-stage human antibody asset targeting the novel immuno-oncology target GARP, a protein believed to contribute to immunosuppressive effects of T-cells. argenx received an upfront payment of $40M.
FINANCIAL HIGHLIGHTS (as of 30 June, 2016) (compared to financial highlights as of 30 June 2015)

Operating income of EUR 7.0 million (30 June 2015: EUR 4.3 million).
Net loss of EUR 7.4 million (30 June 2015: EUR 7 million).
Cash position of EUR 108.7 million (cash, cash-equivalents and financial assets) allowing Company to pursue development of its product portfolio as planned.

(Filing, Annual, ImmunoGen, 2016, AUG 25, 2016, View Source [SID:1234514746])

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On August 24, 2016 Biothera Pharmaceuticals, Inc. reported a collaboration with Merck, known as MSD outside the United States and Canada, to expand the companies’ ongoing clinical program evaluating KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 inhibitor, in combination with Biothera’s Imprime PGG, a Pathogen Associated Molecular Patterning molecule, or PAMP (Press release, Biothera Pharmaceuticals, AUG 24, 2016, View Source [SID1234562109]). Imprime PGG acts as an immunological "ignition switch" enlisting the innate immune system to enhance the therapeutic efficacy of tumor targeting, anti-angiogenic, and immune checkpoint inhibitor antibodies.

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Under this new collaboration, a Phase 2 clinical trial is anticipated to enroll up to 95 patients who have either advanced melanoma no longer responding to initial treatment with a checkpoint inhibitor therapy or TNBC whose disease has progressed following treatment with one or more lines of therapy for metastatic disease. Biothera will be the sponsor of the study, which is planned to begin in the fourth quarter of 2016. Merck will provide clinical supplies of KEYTRUDA for the planned studies. Other terms of the collaboration were not disclosed.

Biothera previously announced an agreement in December 2015 for Merck to supply KEYTRUDA for a Phase 1b/2 clinical study testing combination therapy with Imprime PGG in NSCLC patients. The Big Ten Cancer Research Consortium will conduct the multi-center trial, which is expected to commence this fall.

Barry Labinger, Chief Executive Officer of Biothera, stated, "Combination therapies with breakthrough medicines such as KEYTRUDA are potentially the next major advance in the treatment of cancer. We believe that Imprime PGG is uniquely suited to complement immune checkpoint inhibitor therapy and meaningfully enhance patient outcomes. The trial will assess safety and efficacy, as well as provide biomarker and pharmacodynamic data that will inform the design of potential Phase 3 pivotal studies."

Eric Rubin, M.D., Vice President and Therapeutic Area Head, Oncology Early-stage Development, Merck Research Laboratories, commented, "As a leading innovator in the field of immuno-oncology, Merck is dedicated to advancing breakthrough science by continuing to identify novel combinations with potential to improve the care for people with cancer. We are pleased to expand our partnership with Biothera as we explore the potential for combining KEYTRUDA with their lead candidate."

On August 24, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported its participation in four upcoming investor conferences (Press release, TESARO, AUG 24, 2016, View Source [SID:1234514709]). The four conferences are:

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The Wells Fargo Global Healthcare Conference at the Westin Boston Waterfront in Boston on Wednesday, September 7. Lonnie Moulder, CEO of TESARO, and Mary Lynne Hedley, Ph.D., President and COO of TESARO, will participate in an analyst-led moderated Q&A from 3:30 to 4:00 PM ET and in meetings with investors.

The 11th Annual Citi Biotech Day at the Mandarin Oriental Hotel in Boston on Thursday, September 8, 2016. Lonnie Moulder will participate in a panel titled "Developing Cancer Therapeutics in 2016" at 8:00 AM ET. Also, Lonnie Moulder and Mary Lynne Hedley, Ph.D. will host meetings with investors.

The Baird 2016 Healthcare Conference at the New York Palace Hotel in New York City on Thursday, September 8. Tim Pearson, EVP and CFO of TESARO, is scheduled to participate in an analyst-led fireside chat from 12:15 to 12:45 PM ET, and in meetings with investors.

The Leerink Partners Roundtable Series: Rare Disease & Immuno-Oncology at the Lotte New York Palace in New York City on September 29, 2016. Lonnie Moulder and Jeff Hanke, Ph.D., EVP and Chief Scientific Officer of TESARO, will participate in an analyst-led fireside chat from 1:00 to 1:30 PM ET, and in meetings with investors.

On August 24, 2016 Cantargia AB ("Cantargia") reported its interim report for January – June 2016 is available on the company website (www.cantargia.com/Investors/Reports) (Press release, Cantargia, AUG 24, 2016, View Source [SID:1234514711]).

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Significant events in the second quarter

· The exercise period for warrants of series TO 1 and TO 3 began on 23 March 2016 and ended on 13 April 2016. In total, 4,127,260 warrants of both series were exercised, representing around 83.5 per cent of the number of warrants issued. Through the warrants Cantargia raised approximately SEK 31.4 million before issue costs.

· During the period the Company gave investor presentations at the international BioEquity conference in Copenhagen on 10 May 2016 and at the Småbolagsdagen small cap investor event at the Sheraton Stockholm Hotel on 13 June 2016.

· The annual report for the financial year 2015 was published on 29 April 2016. The company held its Annual General Meeting on 25 May 2016 and published a report on the AGM the following day. The annual report and AGM report are available for download on the company’s website, www.cantargia.com.

· Cantargia received a Notice of Allowance from the US Patent Office for IL1RAP as target molecule for antibody-based treatment in acute lymphoblastic leukemia followed by a Notice of Allowance for IL1RAP as target molecule for antibody-based treatment in solid tumours from the same patent office. The company also received formal approval in Japan of a patent for solid tumours.

· The company announced that its CAN04 product candidate has been shown to have a high level safety in high doses – repeated treatment with up to 100 mg/kg. During the period Cantargia also decided that the company will conduct further process development studies to establish a strong foundation for long-term production and that the start of the GLP toxicity study will therefore be postponed until autumn 2016. Consequently, the start of clinical studies will also be postponed until the end of the first quarter of 2017.

· A third party filed an opposition to Cantargia’s patent in Europe for IL1RAP as a target molecule for antibody treatment and leukemia diagnostics. Cantargia will be working with its patent agents and the European Patent Office to conduct the process in a professional and correct manner.

Significant events after the end of the period

· In July Cantargia announced that the US Patent Office had approved the company’s application for IL1RAP as target molecule for antibody-based treatment of solid tumours.

· In August Cantargia announced that the company’s former CEO, Agneta Svedberg, has exercised 1,250 warrants of series 2011/2016. The exercise of the warrants will raise SEK 250,212.50 for Cantargia.

Financial information

First half (1 Jan 2016 – 30 Jun 2016)

· Other operating revenue was kSEK 0 (0).

· Earnings after financial items were kSEK -16,023 (-9,059).

· Earnings per share were approximately SEK -0.91 (-0.68).

· The equity/assets ratio was around 87 (89) per cent compared with the beginning of the year.

Second quarter (1 Apr 2016 – 30 Jun 2016)

· Other operating revenue was kSEK 0 (0).

· Earnings after financial items were kSEK -7,926 (-5,432).

· Earnings per share were approximately SEK -0.45 (-0.41).

Definitions

· Earnings per share: Profit for the period divided by 17,633,134 shares as at 30 June 2016.

· Equity/assets ratio: Equity divided by total capital.

· Unless otherwise indicated, figures in parentheses refer the same period in the previous year.

This constitutes information that Cantargia is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person at 8:30 (CEST) on August 24, 2016.

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