Nordic Nanovector – Private placement successfully completed

On January 25, 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 on 24 January 2019 regarding the contemplated private placement of new shares in the Company (Press release, Nordic Nanovector, JAN 25, 2019, View Source [SID1234553483]).

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 Company announces today that it has raised approximately NOK 222 million (USD 26 million) in gross proceeds through a private placement of 4,943,094 new shares (the "Private Placement"). The Private Placement was completed at a subscription price of NOK 45 per share, which was determined through an accelerated book-building process.

DNB Markets and Jefferies International Limited acted as Joint Global Coordinators and Joint Bookrunners (the "Joint Global Coordinators"), and Kempen & Co N.V. acted as Joint Bookrunner (together with the Joint Global Coordinators, the "Joint Bookrunners") in connection with the Private Placement. The Private Placement, which was oversubscribed, attracted strong interest from both existing shareholders and new institutional investors, Norwegian as well as international.

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

Manufacturing development activities (including Process Validation studies) for Betalutin
A scale-up of the Company’s clinical and commercial activities in preparation for a commercial launch of Betalutin
General corporate purposes
The Private Placement and the issuance of the new shares was resolved by the Company’s Board of Directors (the "Board") at a board meeting held on 25 January 2019, based on the authorisation granted to the Board at the Company’s annual general meeting on 30 May 2018.

Notification of allotment of the new shares in the Private Placement and payment instructions will be sent to the applicants through a notification from the Joint Bookrunners. Settlement of the new shares towards investors will be made on a delivery versus payment basis on 29 January 2019 (T+2 settlement), by delivery of 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 Joint Bookrunners), the Company and HealthCap VI L.P. The new shares delivered to the subscribers will thus be tradable from allocation. The shares borrowed for settlement of the Private Placement will be redelivered to HealthCap VI L.P. in the form of new shares in the Company.

Following registration of the new share capital pertaining to the Private Placement in the Norwegian Register of Business Enterprises, which is expected to take place on or about 31 January 2019, the Company will have an issued share capital of NOK 10,874,807.80, divided into 54,374,039 shares, each with a par value of NOK 0.20.

The Company’s Board of Directors has, subject to an approval from the Company’s general meeting, resolved to carry out a repair offering of up to 777,777 new shares (the "Repair Offering"), raising gross proceeds of approximately NOK 35 million (USD 4 million). Shareholders in the Company as of 24 January 2019, as registered in the VPS on 28 January 2019 (the "Record Date"), who were not allocated Offer Shares in the Private Placement and who are not resident in a jurisdiction where such offering would be unlawful, or would (in jurisdictions other than Norway) require any prospectus filing, registration or similar action, will receive subscription rights in the Repair Offering based on their shareholding as of the Record Date. The subscription rights will not be listed or tradable. The subscription price in the Repair Offering will be the same as in the Private Placement, i.e. NOK 45 per share. Launch of the Repair Offering is conditional upon (i) approval by the Company’s extraordinary general meeting, which is expected to be held on or about 18 February 2019 (the "EGM") and (ii) the publication of a prospectus approved by the Norwegian Financial Supervisory Authority. The subscription period in the Repair Offering is expected to commence shortly after the EGM and the publication of the prospectus, which will cover the offering and listing of the shares in the Repair Offering.

The following primary insiders were allocated shares in the Private Placement:

HealthCap VI L.P., a shareholder to whom one of the members of the Company’s board of directors is associated, was allocated 265,000 shares in the Private Placement, subject to completion of the Private Placement, it will hold a total of 5,710,833 Shares, corresponding to 10.5% of the issued share capital after completion of the Private Placement.

Eduardo Bravo, CEO of the Company, was allocated 21,674 shares in the Private Placement, subject to completion of the Private Placement he will hold a total of 25,874 Shares, corresponding to 0.0% of the issued share capital after completion of the Private Placement. Eduardo Bravo also holds 250,000 PSUs and has a right to be granted a further 50,000 PSUs as part of the Company’s annual grant of PSUs in the first quarter of 2019.

Tone Kvåle, CFO of the Company, and related parties of Tone Kvåle were allocated 6,667 shares in the Private Placement, subject to completion of the Private Placement she will, together with related parties, hold a total of 186,275 Shares, corresponding to 0.3% of the issued share capital after completion of the Private Placement. Tone Kvåle also holds 20,000 PSUs and 315 000 options.

Malene Brondberg, VP Investor Relations and Corporate Communications of the Company, was allocated 5,555 shares in the Private Placement, subject to completion of the Private Placement she will hold a total of 5,555 Shares, corresponding to 0.0% of the issued share capital after completion of the Private Placement. Malene Brondberg also holds 20,000 PSUs.

Bavarian Nordic Completes Enrollment of First Stage in Chordoma Phase 2 Trial

On January 25, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported, that the first stage of a Phase 2 study of its novel, targeted cancer immunotherapy candidate, BN-Brachyury in the treatment of advanced chordoma has completed recruitment of the planned 10 patients ahead of schedule (Press release, Bavarian Nordic, JAN 25, 2019, View Source [SID1234532899]).

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 multi-site trial, which holds the potential to serve as a registration trial, aims to determine if the combination of BN-Brachyury vaccine and the current standard of care, radiation therapy, results in a clinically meaningful objective response rate (ORR) within 12 months of radiation therapy, a timeframe during which historical controls show an ORR of less than 5% with radiation alone. Radiation has been shown to inflame the tumor, releasing cancer antigens. BN-Brachyury is designed to teach T cells to attack brachyury-expressing cells and kill the tumor cells.

As per the study design, the first 10 patients have now been enrolled, thus completing recruitment of stage 1 of the study. First results from this stage are expected to become available in the second half of 2019. If at least one objective response occurs in the first 10 patients, the study will advance into stage 2 with enrollment of additional 19 patients with an overall goal of 4 objective responses for all patients in the study for a successful outcome.

"We are excited about the great interest in our chordoma study, leading to a rapid enrollment of patients for the first part of the study," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. "As there are no approved drugs for the treatment of chordoma, patients are truly limited in their options to control the disease, particularly in the advanced stage. We hope to demonstrate, that a targeted immunotherapy can improve the outcome for these patients and provide hope for a better life with cancer."

For more information on the trial, please visit: View Source

About chordoma
Chordoma is a rare cancer that universally overexpresses brachyury and occurs in the base of the skull and spine. There are approximately 1,000 new cases of chordoma diagnosed in the U.S. and E.U. annually, and 10,000 people living with the disease. Current treatments have resulted in limited success against chordoma, with a historical objective response rate of less than 5% with radiation alone.

About BN-Brachyury
Bavarian Nordic’s novel immuno-oncology candidate, BN-Brachyury, targets a key prognostic indicator of several common (e.g. colorectal, prostate, small cell lung, and triple negative breast cancer) and rare or orphan (e.g. chordoma, thyroid, neuroendocrine) cancers. Brachyury is a transcription factor that is believed to play a prominent role in the metastasis and progression of tumors. Expression of brachyury is highly correlated with metastatic disease, poor overall survival, multi-drug resistance, and decreased survival rates. BN-Brachyury utilizes a prime-boost vaccination regimen that has been optimized to include the gene for brachyury and other molecules known to increase immune activation. Patients will receive a primer of MVA-BN Brachyury followed by a booster doses of the recombinant fowlpox virus. A previous phase 1 trial demonstrated that MVA-BN-Brachyury could safely target brachyury and induce brachyury-specific T-cell immune responses.

BN-Brachyury has received orphan drug status from the FDA and may be eligible for Breakthrough Designation.

Data Highlighting Potential Benefits Of Lm Platform Presented At 2019 Keystone Symposia Conference On Cancer Vaccines

On January 25, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that two presentations highlighting the potential of Advaxis vectors to generate T cell responses to a large percentage of neoantigens and to promote antigen spreading and potentially slow progression of prostate cancer, were presented at the 2019 Keystone Symposia on Cancer Vaccines, held January 19-24 in Vancouver (Press release, Advaxis, JAN 25, 2019, View Source [SID1234532900]).

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 first presentation, "Neoantigen prioritization for use in a Listeria monocytogenes cancer vaccine" delivered by Brandon Coder, Ph.D., Associate Director Research & Development at Advaxis, shows the impact of CD8+ T cell responses generated to a large proportion of neoantigens, including those that were not immunogenic as peptide vaccines as well as large frameshift mutations (FSMs) that generated tumor-infiltrating lymphocytes that controlled tumor growth in preclinical CT-26 and MC-38 mouse models. The data presented support the potential of Advaxis vectors to be among the most efficient and effective at generating CD8+ T cell responses to neoantigens, including some that are not immunogenic by alternative methods of vaccination.

The second presentation, "Magnitude of anti-PSA T cell response is associated with antigen spreading and slowing in PSA and PAP velocity in ADXS-PSA treated mCRPC patients," was delivered by Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. These data are from 13 patients treated in the ADXS-PSA monotherapy arm of Advaxis’ Phase 1/2 clinical trial of men with metastatic, castration-resistant prostate cancer (mCRPC). The presentation focused on the 56% of ADXS-PSA monotherapy patients (5/9) who exhibited a greater than three-fold increase above baseline in the magnitude of their PSA-specific T cell responses. All nine ADXS-PSA patients who received three or more treatments showed T cell responses against one or more prostate cancer antigens not included in ADXS-PSA, providing evidence of antigen spreading. Additionally, a greater magnitude of the PSA-specific T cell responses in ADXS-PSA-treated mCRPC patients was associated with more antigen spreading than those with a less than three-fold increase. Similarly, those patients with a greater than three-fold increase in PSA-specific T cells also exhibited a significant slowing in PSA and PAP velocities, which could support the potential for delaying progression and improving survival in larger studies. As previously reported, ADXS-PSA monotherapy showed a manageable safety profile with Grades 1–2 chills/rigors and fever in all patients and Grade 3 and Serious Adverse Events in five and two patients, respectively.

"These presentations highlight some of the potential benefits of the drug constructs from our proprietary Lm platform, namely the efficient generation of CD8+ T cell responses against neoantigens as well as the potential improvement of clinical endpoints due to the magnitude of these T cell responses and antigen spreading. The data directly support our ongoing investigations of the ADXS-NEO and ADXS-PSA constructs as well as future studies of the various drug constructs from our ADXS-HOT program," said Dr. Petit.

Allergan Announces Increased Quarterly Dividend and Annual General Meeting of Shareholders Date

On January 25, 2019 Allergan plc (NYSE: AGN) reported that its Board of Directors has approved an increase in the Company’s quarterly cash dividend for 2019 to $0.74 per ordinary share (Press release, Allergan, JAN 25, 2019, View Source [SID1234532901]). The Board declared a cash dividend for the first quarter of 2019 to be paid on March 15, 2019 to shareholders of record at the close of business on February 15, 2019.

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!

"Allergan’s increased dividend for 2019 demonstrates our confidence in our long-term business strategy and our commitment to executing on our capital allocation priorities. We remain committed to increasing our dividend annually," said Brent Saunders, Chairman and CEO of Allergan.

Allergan also announced that its 2019 Annual General Meeting of Shareholders will be held on May 1, 2019 in Dublin, Ireland. The Company’s Board of Directors has set the close of business on March 5, 2019 as the record date for determining shareholders eligible to vote at the meeting.

Actinium Pharmaceuticals, Inc. to Present at Noble Capital Markets’ 15th Annual Investor Conference

On January 25, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that it will present at NobleConXV – Noble Capital Markets’ Fifteenth Annual Investor Conference at the W Hotel, Fort Lauderdale, Florida on Tuesday, January 29th at 12:30 pm EST (Press release, Actinium Pharmaceuticals, JAN 25, 2019, View Source [SID1234532902]). Actinium is the only company with a multi-disease, multi-target, drug development pipeline focused on targeted conditioning via its ARC or Antibody Radiation Conjugate Approach. Details of Actinium’s presentation are as follows:

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!

Date: Tuesday, January 29th
Time: 12:30 PM ET
Room: Studio 4
Venue: W Hotel, Fort Lauderdale, Florida

Members of Actinium’s Executive team will be available for 1-on-1 meetings with conference attendees. Those interested in scheduling a meeting with Actinium may do so through the conference’s system View Source or by contacting Steve O’Loughlin, Actinium’s Principal Financial Officer via email to [email protected].