Nordic Nanovector to Present at Redeye Pre-ASCO Seminar, Jefferies Healthcare Conference and ABGSC Oncology Seminar

On May 27, 2019 Nordic Nanovector ASA (OSE: NANO) reported that members of its senior management team will participate and present at the following upcoming investor conferences during May and June (Press release, Nordic Nanovector, MAY 27, 2019, View Source [SID1234536590]):

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Redeye Pre-ASCO seminar in Stockholm on 28 May
Jefferies Healthcare conference in New York on 4-7 June
ABGSC Oncology seminar in Oslo on 11 June
The company presentation to be given at these events will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations on the first day of each conference.

For further information, please contact:

IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44-7561-431-762
Email: [email protected]

Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44-207-638-9571
Email: [email protected]

Medivir to Present at the Redeye Pre-ASCO Seminar on May 28

On May 27, 2019 Medivir AB (Nasdaq Stockholm: MVIR) reported that the company will participate at the Redeye Pre-ASCO Seminar in Stockholm. The presentation will take place at 9.15am on Tuesday, May 28, 2019 (Press release, Medivir, MAY 27, 2019, View Source [SID1234536589]). Dr. Uli Hacksell, CEO of Medivir, will present the latest development and the company´s future.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The presentation will be available via Medivirs website; www.medivir.com.

For further information, please contact:

Uli Hacksell
CEO, Medivir AB
mobile: +46(0)73-125-0615.

BioMarin to Host Conference Call Tuesday, May 28, 2019 to Provide a Valoctocogene Roxaparvovec Phase 2 and Phase 3 Update

On May 27, 2019 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), reported that management will host a conference call and webcast on Tuesday, May 28 at 8:00am ET to discuss program updates (Press release, BioMarin, MAY 27, 2019, https://www.prnewswire.com/news-releases/biomarin-to-host-conference-call-tuesday-may-28-2019-to-provide-a-valoctocogene-roxaparvovec-phase-2-and-phase-3-update-300857066.html [SID1234536588]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Conference Call and Webcast Information
Interested parties may access the live video webcast that will include audio and a slide presentation via the investor section of the BioMarin website, www.biomarin.com. A replay of the meeting will be archived on the site for one week.

For those who want access to the audio portion only, please use the dial-in information below:

U.S. / Canada Dial-in Number: (866) 502-9859
International Dial-in Number: (574) 990-1362
Conference ID: 2295086

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 2295086

Medicure Reports Financial Results for Quarter Ended March 31, 2019

On May 27, 2019 Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a pharmaceutical company, reported its results from operations for the quarter ended March 31, 2019 (Press release, Medicure, MAY 27, 2019, View Source [SID1234536587]).

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Quarter Ended March 31, 2019 Highlights:

Recorded net revenue from the sale of AGGRASTAT (tirofiban hydrochloride) of $4.8 million during the quarter ended March 31, 2019 compared to $6.1 million for the quarter ended March 31, 2018;

$55.5 million in cash and short-term investments as at March 31, 2019;

Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended March 31, 2019 was negative $1.7 million compared to adjusted EBITDA of $927,000 for the quarter ended March 31, 2018; and

Net loss for the quarter ended March 31, 2019 was $2.8 million compared to net income of $1.4 million for the quarter ended March 31, 2018.
Financial Results

Net revenues for the three months ended March 31, 2019 were $4.9 million compared to $6.1 million for the three months ended March 31, 2018. Net revenues from AGGRASTAT for the three months ended March 31, 2019 were $4.8 million compared to $6.1 million for the three months ended March 31, 2018. Additionally, ReDSTM point of care system ("ReDSTM"), contributed $103,000 of net revenue for the three months ended March 31, 2019.

The Company continued to experience strong patient market share held and strong hospital demand for AGGRASTAT during the three months ended March 31, 2019, however increases in volume compared to the three months ended March 31, 2018 were offset by increased price competition that resulted in lower discounted prices for AGGRASTAT throughout the quarter.

Diversification of revenues remains an important aspect of the Company’s focus with Medicure concentrating on the sales and marketing of AGGRASTAT, growing the sales of ZYPITAMAGTM (pitavastatin) and marketing the recently licensed ReDSTM device system.

Adjusted EBITDA for the three months ended March 31, 2019 was negative $1.7 million compared to $927,000 for the three months ended March 31, 2018. The decrease in adjusted EBITDA for the three months ended March 31, 2019 is the result of the higher selling, general and administration expenses caused by the incurrence of additional costs relating to the commercial organization due to the Company’s additional products, higher cost of goods sold attributable to an increased volume of AGGRASTAT sold and lower revenues experienced during the quarter ended March 31, 2019.

Net loss for the three months ended March 31, 2019 was $2.8 million or $0.18 per share. This compares to net income of $1.4 million or $0.09 per share for the three months ended March 31, 2018. Similar to the decrease in adjusted EBITDA, the net loss for the three months ended March 31, 2019 is the result of higher selling, general and administration expenses, higher cost of goods sold and lower revenues experienced during the quarter. Foreign exchange loss relating to a decrease in the value of the U.S. dollar experienced during the quarter ended March 31, 2019 also contributed to the net loss.

At March 31, 2019, the Company had unrestricted cash and short-term investments totaling $55.5 million compared to $71.9 million as of December 31, 2018. The decrease in cash is primarily due to the investment made in Sensible Medical Innovations Ltd. and a decrease in the value of the U.S. dollar as at March 31, 2019 compared to December 31, 2018. Cash flows used in operating activities for the three months ended March 31, 2019 totaled $1.9 million.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

Notes

(1) The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non-cash and non-recurring items". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the quarters ended March 31, 2019 and 2018 results prepared using International Financial Reporting Standards ("IFRS"), do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies.

Conference Call Info:

Topic: Medicure’s Q1 2019 Results

Call date: Tuesday, May 28, 2019

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll-free: 1 (888) 465-5079 Canada toll: 1 (416) 216-4169

United States toll-free: 1 (888) 545-0687

Passcode: 6562291#

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.

Last Patient Enrolled in the Phase 2 Trial with Transgene’s TG4010 + Nivolumab + Chemotherapy for the First-Line Treatment of Advanced Lung Cancer (NSCLC)

On May 27, 2019 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of solid tumors, reported that the last patient has been included in the Phase 2 trial evaluating TG4010 in combination with Opdivo (nivolumab) and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) with low or no expression of PD-L1 by the tumor cells (Press release, Transgene, MAY 27, 2019, View Source [SID1234536586]).
Transgene confirms that the study’s primary endpoint (objective response rate – ORR) on a minimum of 35 evaluable patients will be reported in Q4 2019.

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The Phase 2 clinical trial is exploring the tolerability and efficacy of the combination regimen of Transgene’s TG4010, an investigational active immunotherapy against MUC1 tumor-associated antigen, with Bristol-Myers Squibb’s immune checkpoint inhibitor, Opdivo (nivolumab), which acts by overcoming immune suppression, and standard platinum doublet chemotherapy.

This multi-center single-arm trial has enrolled patients both in the USA and Europe.

The trial has overall ORR as primary endpoint. The study will also assess the safety and tolerability of the regimen together with other efficacy and immunological parameters. More information on the trial can be found on clinicaltrials.gov (NCT03353675).

This trial is being conducted by Transgene under a clinical collaboration agreement with Bristol-Myers Squibb, which is supplying nivolumab.

"We are looking forward to reporting the first efficacy data of our active immunotherapy TG4010, with nivolumab and chemotherapy as a first-line treatment of advanced lung cancer for patients whose tumors express low or undetectable levels of PD-L1", said Maud Brandely, Chief Medical Officer of Transgene. "Today anti-PD-1 therapy is relatively less effective in this large subset of NSCLC patients. With this triple combination regimen, we aim to significantly improve treatment outcomes in this major oncology indication."

The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of increased response rate, progression-free survival and overall survival in a randomized, double-blind, placebo-controlled Phase 2b trial in first-line treatment of patients with advanced non-squamous NSCLC (Quoix et al. Lancet Oncol. 2015).

About TG4010
TG4010 is an active immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2 (IL2). It is based on a modified Vaccinia virus (MVA) and has been shown to induce an immune response against MUC1 expressing tumors, such as non-small cell lung cancer (NSCLC). Its mechanism of action and excellent safety profile make TG4010 a very suitable candidate for combinations with other therapies, including immune checkpoint inhibitors and chemotherapy. The combination of TG4010 immunotherapy and chemotherapy has demonstrated significant efficacy in terms of progression-free survival and overall survival in patients with advanced stage NSCLC (Quoix et al. Lancet Oncol. 2015).
TG4010 is being investigated for the first-line treatment of NSCLC in combination with nivolumab and chemotherapy in patients whose tumors express low or undetectable levels of PD-L1 (NCT03353675).

About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is one of the most common malignancies worldwide with an estimated 2.1 million new cases annually. It is also a leading cause of cancer-related deaths, accounting for an estimated 1.7 million deaths (Source: GLOBOCAN 2018). Advanced lung cancer remains one of the cancer types with the worst prognosis (five-year survival rate for advanced NSCLC of less than 5%), underlining the still unmet need in this disease despite recent progress.