On October 17, 2019 Nordic Nanovector ASA (OSE: NANO) ("Nordic Nanovector" or the "Company"), a biopharmaceutical company dedicated to extending and improving the lives of patients with haematological cancers through the development and commercialisation of innovative targeted therapeutics, reported the launch of a private placement of new shares (the "Offer Shares") representing up to approximately 20% of the outstanding share capital of the Company at this date (the "Private Placement") (Press release, Nordic Nanovector, OCT 17, 2019, View Source [SID1234553443]). DNB Markets and Jefferies International Limited are acting as Joint Global Coordinators and joint bookrunners (the "Joint Global Coordinators"), and ABG Sundal Collier ASA is acting as joint bookrunner (together with the Joint Global Coordinators, the "Managers") in connection with the Private Placement .

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Nordic Nanovector intends to use the net proceeds from the Private Placement for the following purposes:

Continued clinical development, (including completion of enrolment of the PARADIGME study), and commercial preparation of Betalutin.
Manufacturing development activities for Biological License Application (BLA) readiness.
General corporate purposes.
The subscription price and the number of shares to be issued in the Private Placement will be determined through an accelerated bookbuilding process. The bookbuilding period and the application period for the Private Placement commence today at 16:30 hours CEST and will close at 08:00 hours (CEST) on 18 October 2019 (the "Application Period"). The Company and the Managers reserve the right to close or extend the Application Period at any time and for any reason. If the Application Period is shortened or extended, any other dates referred to herein may be amended accordingly.

The Company’s largest shareholder, HealthCap VI L.P., has informed the Company that it will participate in the Private Placement.

The minimum subscription and allocation amount in the Private Placement will be the NOK equivalent of EUR 100,000, provided that the Company may, at its sole discretion, allocate an amount below EUR 100,000 to the extent applicable exemptions from the prospectus requirement pursuant to applicable regulations, including the Norwegian Securities Trading Act and ancillary regulations, are available. Allocation of the Offer Shares will be determined at the end of the bookbuilding process, and the final allocation will be made by the Company’s Board of Directors (the "Board") at its sole discretion, following advice from the Managers.

The Offer Shares will be issued based on an authorisation granted to the Company’s Board at the Company’s annual general meeting on 25 April 2019 (the "Authorisation").

The Board has considered alternative structures for the raising of new equity. Following careful considerations, the Board is of the view that it will be in the common interest of the Company and its shareholders to raise equity through a private placement setting aside the pre-emptive rights of the shareholders. By structuring the transaction as a private placement, the Company will be in a position to raise capital in an efficient manner, with a lower discount to the current trading price and with significantly lower risks compared to a rights issue. In addition, the Private Placement is subject to marketing through a pre-sounding and a publicly announced bookbuilding process. By this, a market based subscription price will be achieved. The Company will also consider whether or not to commence a repair offering towards the existing shareholders who did not participate in the Private Placement.

The Private Placement will be directed towards Norwegian and international investors, in each case subject to and in compliance with applicable exemptions from relevant prospectus or registration requirements. Notification of allotment and payment instructions is expected to be issued to the applicants on or about 18 October 2019 through a notification to be issued by the Managers.

The Private Placement is divided into two tranches:

· A number of Offer Shares corresponding to approximately 10% of the Company’s share capital will be settled with existing and unencumbered shares in the Company that are already listed on the Oslo Stock Exchange, pursuant to a share lending agreement between DNB Markets (on behalf of the Managers), the Company and HealthCap VI L.P., in order to facilitate delivery of listed shares to investors on a delivery versus payment basis (the "Tranche 1 Offer Shares"). The Tranche 1 Offer Shares will be tradable from allocation. The Managers will settle the share loan with a corresponding number of new shares in the Company to be issued by the Board pursuant to the Authorisation, on or about 24 October 2019.

· The Managers are expected to pre-fund the subscription price for the rest of the Offer Shares (the "Tranche 2 Offer Shares") to facilitate a swift registration of the share capital increase in the Norwegian Register of Business Enterprises (the "NRBE"). The Tranche 2 Offer Shares will be tradable from registration of the share capital increase in the NBRE, expected to be on or about 22 October 2019. Delivery of the Tranche 2 Offer Shares will be on a delivery versus payment basis to the investors. The Tranche 2 Offer Shares will be issued by the Board pursuant to the Authorisation.

The Company has agreed with the Managers to a lock-up on future share issuances for a period of 180 days from the closing date, subject to customary exceptions. The Company’s Board and Executive Management have all agreed with the Managers to a lock-up on existing shareholdings for a period of 180 days from the closing date, subject to customary exceptions. In addition, the Company’s largest shareholder, HealthCap VI L.P. has agreed with the Managers to a lock-up for a period of 90 days from the closing date, subject to customary exceptions.

The Company will announce the final number of Offer Shares placed and the final subscription price in the Private Placement in a stock exchange announcement expected to be published before opening of trading on the Oslo Stock Exchange tomorrow, 18 October 2019. Completion of the Private Placement is subject to final approval by the Company’s Board.

Company update

The pivotal PARADIGME trial investigating Betalutin in relapsed/refractory non-Hodgkin’s lymphoma is now recruiting patients at 85 sites in 24 countries. Despite a slower than expected start, PARADIGME is now recruiting in line with the company’s expectations and in line with previous clinical trials in similar patient populations; with 32 patients enrolled to-date, the company aims to complete recruitment of the targeted 130 patients in H2 2020.

The company, working with the trial Contract Research Organisation (CRO), has initiated a suite of actions to meet this enrolment target. Specific actions include applying key learnings from high-recruiting sites, increased visits by senior management, other site engagement programmes and intensified efforts to raise the profile of PARADIGME and Betalutin with key opinion leaders, referrers and influencers.

Nordic Nanovector believes that these initiatives position PARADIGME strongly to reach its key enrolment milestone of 130 patients in H2 2020.

On October 10, 2019 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance exchange, reported that the company plans to release third quarter 2019 financial results on October 24, 2019 (Press release, eHealthInsurance, OCT 10, 2019, View Source [SID1234540935]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Chief Executive Officer Scott Flanders and Chief Financial Officer Derek Yung will host the earnings conference call beginning at 5 p.m. Eastern Time on October 24th to discuss these results.

Individuals interested in listening to the conference call may do so by dialing (877) 930-8066 for domestic callers and (253) 336-8042 for international callers. The participant passcode is 6089464.

A telephone replay will be available two hours following the conclusion of the call for a period of 7 days and can be accessed by dialing (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. The call ID for the replay is 6089464. The live and archived webcast of the call will also be available on the company’s website at www.ehealthinsurance.com under the Investor Relations section.

On October 10, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the first patient has been enrolled in an exploratory Phase 2 clinical trial evaluating the ability of defibrotide to prevent neurotoxicity in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving CAR T-cell therapy (Press release, Jazz Pharmaceuticals, OCT 10, 2019, View Source [SID1234540936]). The prospective, multicenter, open-label, single-arm study will evaluate the safety and efficacy of defibrotide in the prevention of CAR T-cell associated neurotoxicity in patients with relapsed or refractory DLBCL receiving axicabtagene ciloleucel.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"The introduction of CAR-T therapies to the oncology treatment landscape is groundbreaking but can be associated with serious complications such as neurotoxicity," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "At Jazz, we strive to improve outcomes for patients, and we are committed through our development program to explore the potential of defibrotide, including as a preventative treatment for neurotoxicity in patients receiving CAR-T therapy."

Patients may experience neurotoxicity after CD19 targeted CAR-T therapy,1 and while the exact cause is unknown, research suggests that endothelial cell damage may play a role.1,2 Some researchers hypothesize that the damage caused by cytokine release after CAR-T therapy may compromise the ability of endothelial cells to protect the central nervous system (CNS), causing neurotoxicity.3 This study will explore whether defibrotide could help prevent CNS endothelial cell damage, thereby protecting the CNS and minimizing neurotoxicity.

This study will be conducted in two parts, with the first part evaluating the safety of a 2.5 mg/kg/dose and a 6.25 mg/kg/dose of defibrotide based on a standard 3+3 design. Part two will evaluate the safety and efficacy of defibrotide at the recommended dose for the prevention of CAR-T-associated neurotoxicity. The primary endpoint is the incidence of CAR-T-associated neurotoxicity (any grade, defined by Common Terminology Criteria for Adverse Events [CTCAE] v5.0) by CAR-T Day +30.

Approximately 35 eligible patients will be enrolled at six medical centers across the United States. Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at: View Source (ClinicalTrials.gov Identifier: NCT03954106).

About Defitelio (defibrotide sodium)
In the U.S., Defitelio (defibrotide sodium) injection 80mg/mL received U.S. FDA marketing approval on March 30, 2016 for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT) and is the first and only FDA-approved therapy for patients with this rare, potentially fatal complication. Defitelio is not approved for the treatment or prevention of CAR T-cell associated neurotoxicity. Defitelio is contraindicated in patients currently taking anticoagulants or fibrinolytics and in patients who are allergic to Defitelio or any of its ingredients. Defitelio may increase the risk of bleeding and should be withheld or stopped if significant bleeding occurs. Patients should be monitored for allergic reactions, especially if there is a history of previous exposure to Defitelio. The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds.

Please see full Prescribing Information for Defitelio.

In Europe, defibrotide is marketed under the name Defitelio ▼ (defibrotide). In October 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients undergoing HSCT therapy. It is the first and only approved treatment in Europe for severe VOD. In Europe, Defitelio is indicated in patients over one month of age. It is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system found under section 4.8 of the SmPC.
(View Source)

About CAR-T Associated Neurotoxicity
Chimeric antigen receptor (CAR) T-cell therapy is an emerging immunotherapy approach for the treatment of hematologic malignancies. 4 The two primary toxicities associated with CAR T-cell therapy include cytokine release syndrome (CRS) and neurotoxicity.4 Many patients experience neurotoxicity after CD19 targeted CAR-T therapy,1 and while the exact cause is unknown, research suggests that endothelial cell damage may play a role.1,2 The damage caused by CAR-T therapy may compromise the ability of endothelial cells to protect the central nervous system (CNS), causing neurotoxicity.3

On October 10, 2019 IDEXX Laboratories, Inc. (NASDAQ: IDXX), a global leader in veterinary diagnostics, veterinary practice software and water microbiology testing, reported that it has scheduled the release of its 2019 third quarter financial results for Thursday, October 31, 2019 before the market opens (Press release, IDEXX Laboratories, OCT 10, 2019, View Source [SID1234540937]). The Company will conduct an analyst conference call beginning at 8:30 a.m. ET on that day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Individuals can access a live webcast of the conference call through a link on the IDEXX website, www.idexx.com/investors. An archived edition of the webcast will be available after 1:00 p.m. ET on that day via the same link and will remain available for one year.

The live call also will be accessible by telephone. To listen to the live conference call, please dial 1-800-230-1096 or 1-612-332-0335 and reference confirmation code 472946. Replay of the conference call will be available through Thursday, November 7, 2019 by dialing 1-800-475-6701 or 1-320-365-3844 and referencing replay code 472946.

On October 10, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that it will publish its Q3 Announcement 2019 on 17 October 2019 (Press release, 4SC, OCT 10, 2019, View Source [SID1234540921]). On this day, the Management of 4SC AG will host a conference call at 2:30 pm CEDT (8:30 am EDT) to inform about important developments in the reporting period and beyond.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Investors, financial analysts, and journalists interested in participating in the conference call can access via the telephone numbers stated below. Please join the event conference 5-10 minutes prior to the start time. You will be asked to provide the confirmation code.

Date: 17 October 2019
Time: 2:30 pm CEDT (8:30 am EDT)
Phone Numbers: +49 (0)32 22109 8334 (Germany)
+44 (0)20 3936 2999 (United Kingdom)
+1 646 664 1960 (United States)
Confirmation Code: 304466

A presentation document supporting the conference call will be available on 17 October 2019, at 4SC’s website. After the event, a replay can be accessed from there as well.