Nordic Nanovector Appoints Dr Christine Wilkinson Blanc as Chief Medical Officer

On August 10, 2020 Nordic Nanovector ASA (OSE: NANO) reported that Dr Christine Wilkinson Blanc has been appointed Chief Medical Officer with immediate effect (Press release, Nordic Nanovector, AUG 10, 2020, View Source [SID1234563254]). Dr Wilkinson Blanc is a seasoned pharmaceutical physician with broad experience in oncology and haematology with both large pharmaceutical and emerging biotechnology companies. She has over 25 years of experience in the pharmaceutical industry and has led multiple clinical studies across all phases for a wide range of indications.

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Dr Wilkinson Blanc joins us through her relationship with Weatherden, a specialist clinical development consulting and execution company. She has been Medical Director of Phi-Medics for 10 years, during which time she has provided clinical development consultancy services across oncology and haematology to pharma and biotech companies. The clients she has supported include Roche, Pierre Fabre, Innate Pharma, IPSEN and Antisoma. She was also the Chief Medical Officer of Psioxus Therapeutics between 2013 and 2016.

Prior to this, Dr Wilkinson Blanc was Medical Director in Oncology for a number of companies including Ariad Pharma, Roche, GE Healthcare and Aventis.
Dr Wilkinson Blanc gained her medical qualification, as well as a specialisation in Medical Biology, at the Universities of medicine of Lille and Lyon, France.

Dr Wilkinson Blanc will work with Dr Dominic Smethurst, Nordic Nanovector’s current Interim CMO for a short period to ensure a smooth handover of activities.

Lars Nieba, Interim Chief Executive Officer, commented: "I would like to thank Dominic his dedication and valuable contributions to the advancement of the Company. I am very pleased that Christine has joined Nordic Nanovector as CMO. Her vast experience in clinical development, particularly in oncology and haematology, will be invaluable as we focus our resources and energy on completing the PARADIGME study."

Dr Christine Wilkinson Blanc said: "I am excited to be joining Nordic Nanovector as it works to ensure the completion of PARADIGME in a timely fashion. Betalutin is an exciting one-time treatment which has shown very promising efficacy data in advanced follicular lymphoma. With a clear development path following the recent successful Interim Analysis, I am looking forward to making an important contribution to bring this novel drug candidate to this fragile patient population, which is clearly in need of much improved treatment options."

BERGENBIO ASA: Invitation to second quarter 2020 results webcast presentation

On August 10, 2020 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for unmet medical need, reported that it will be announcing its results for the second quarter 2020 on Tuesday 18 August 2020 (Press release, BerGenBio, AUG 10, 2020, View Source [SID1234563253]). A webcast presentation by BerGenBio’s senior management team will take place at 10:00 am CET.

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The live webcast link will be available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

The second quarter report and presentation will be available on the Company’s website in the Investors/Financial Reports section from 7:00 am CET the same day.

Saniona successfully raises USD 65 million (approximately SEK 567 million) in a directed issue of shares

On August 10, 2020 Saniona (OMX: SANION) ("Saniona" or the "Company"), a clinical-stage biopharmaceutical company focused on rare diseases, reported that its Board of Directors has resolved on a directed issue of 30,660,374 shares to a number of U.S. and international institutional investors and sector specialists based on the authorization granted by the Annual General Meeting held on 6 May 2020 (the "Directed Issue") (Press release, Saniona, AUG 10, 2020, View Source [SID1234563249]).

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The new shares were issued at a subscription price of USD 2.12 per share (SEK18.50), and represents a discount of approximately 45 per cent compared to the volume weighted average price (VWAP) on Nasdaq Stockholm for the period of the last 45 days up to and including 7 August 2020.
Through the Directed Issue, the Company will receive gross proceeds of USD 65 million (approximately SEK 567 million).
The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital and New Leaf Venture Partners among other U.S. and international healthcare investors as well as the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4).
The net proceeds will be used to continue Saniona’s advancement of its late-stage clinical trials with Tesomet in two rare eating disorders, hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as to build its U.S.-based organization in support of these programs.
Comment from Rami Levin, President & CEO of Saniona

"The participation of multiple well-respected U.S. and International institutional healthcare investors in this financing led by RA Capital Management demonstrates the significant potential of Saniona’s rare disease pipeline. With this financing, we will be able to further increase shareholder value by advancing Tesomet to registration for approval, moving our early-stage pipeline into the clinic, and building our U.S. organization. We believe achieving these milestones will position us as potentially the first treatment for two rare diseases, hypothalamic obesity and Prader-Willi Syndrome" said Rami Levin, President and CEO of Saniona.

The Directed Issue

The Board of Directors of Saniona has, in accordance with the issue authorization granted by the Annual General Meeting on May 6, 2020, resolved on a directed issue of 30,660,374 shares at a subscription price of USD 2.12 per share (SEK 18.50), consequently raising gross proceeds of USD 65 million (approximately SEK 567 million) before deduction of costs related to the transaction.

The net proceeds will be used to continue Saniona’s advancement of its late-stage clinical trials with Tesomet in two rare eating disorders, hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as to build its U.S.-based organization in support of these programs.

The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital and New Leaf Venture Partners among other U.S. and international healthcare investors as well the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4). The subscription price per share of USD 2.12 (SEK 18.50) has been established through arms’ length negotiations with a number of institutional investors over a period of time. The Company’s Board of Directors is therefore of the opinion that the subscription price has been set at market terms and accurately reflects current market conditions and demand. The reasons for the deviation from the shareholders’ preferential right were mainly to diversify the shareholder base with financially strong and well reputable U.S. and Swedish institutional investors and sector specialists and to enable a capital raise in a time and cost-efficient manner. It is the assessment of the Board of Directors that the Directed Issue is beneficial to the Company and hence for all existing shareholders.

Through the Directed Issue, the number of shares in the Company will increase by 30,660,374 to 61,043,690, and the share capital will increase by SEK 1,533,018.70 to SEK 3,052,184.50. The Directed Issue entails a dilution of approximately 50 per cent for existing shareholders, based on the number of shares in the Company after the Directed Issue.

In connection with the Directed Issue, the Company has agreed pursuant to a lock-up undertaking, subject to customary exceptions, not to issue additional shares or other securities for a period of 90 days following settlement of the Directed Issue. In addition, in connection with the Directed Issue, members of the Board of Directors and management of Saniona have agreed not to sell any shares or other securities in the Company for a period of 90 days following the settlement of the Directed Issue, subject to customary exceptions and furthermore subject to that warrants of series TO2 (where the exercise period runs between 7 September 2020 – 21 September 2020) or shares subscribed through exercise of such warrants are not covered by the lock-up undertaking.

A prospectus relating to the listing of the shares in the Directed Issue on Nasdaq Stockholm is expected to be approved and registered by the Swedish Financial Supervisory Authority ("SFSA") on or about 13 August, 2020, i.e. before the new shares are subject to trading on Nasdaq Stockholm.

The completion of the Directed Issue is subject to certain customary conditions of the investment agreement entered into by the Company with the investors in connection with the Directed Issue, whereby the investors may for customary reasons terminate the placing in full if it occurs before settlement of the placing.

Financial and legal advisors

Oppenheimer & Co. Inc. and ABG Sundal Collier AB acted as Joint Bookrunners ("Joint Bookrunners") while Setterwalls Advokatbyrå AB acted as legal advisor to Saniona in relation to Swedish law and Goodwin Procter LLP acted as legal advisor to Saniona in relation to US law.

Vycellix CEO to Present Next-Generation Universal Cell Platform to Optimize Allogeneic Cell Therapies at ‘Innate Killer Summit’

On August 10, 2020 Vycellix, Inc., an immuno-centric discovery life science company with a focus on natural killer cell-based (NK cell) therapeutics, reported that its Chairman & CEO, Evren Alici, M.D., Ph.D., will present at the upcoming Innate Killer Summit (Press release, Vycellix, AUG 10, 2020, View Source;utm_medium=rss&utm_campaign=vycellix-ceo-to-present-next-generation-universal-cell-platform-to-optimize-allogeneic-cell-therapies-at-innate-killer-summit [SID1234563248]). The Conference, which will be held as a virtual event on August 25-26, is the largest industry-focused meeting concentrating on all aspects of innate immunity and NK cell therapy breakthroughs.

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Vycellix Presentation Details:

Event: Innate Killer Summit (virtual conference)
Presenter: Evren Alici, M.D., Ph.D., Chairman & CEO, Vycellix, Inc.
Day/Time: Wednesday, August 26 at 9:30am ET
Title: Strategies to Generate Potent NK Cells as Universal Source
Link: View Source

Dr. Alici’s presentation will include discussion reporting on Vycellix’s VY-UC platform, designed to generate immune-privileged universal cells without altering the components that control self-recognition (HLA). Cells modified by VY-UC avoid immune recognition of grafted cells without impacting HLA while conserving viability, functionality, and persistence.

According to Dr. Alici, "We developed VY-UC to abrogate cellular immune response while obviating the need for immune-suppressive drugs in contexts of allogeneic cell therapies, hence redefining ‘off-the-shelf’ treatment strategies for a broad range of uses and indications, including for the development of next-generation NK cells." Dr. Alici is group leader in Hematology at Karolinska Institutet (KI), Department of Medicine, Stockholm, Sweden. He also serves as co-director of NextGenNK, an international Competence Center for the development of next-generation NK cell-based cancer immunotherapies based at KI.

MonTa Biosciences successfully completed regulatory advice meeting with the Danish Medicines Agency

On August 8, 2020 MonTa Biosciences reported that have completed our regulatory meeting with the Danish Medicines Agency to align views on development strategy and interpretation of ICH guidelines (Press release, MonTa Biosciences, AUG 8, 2020, View Source [SID1234618678]). MonTas plan for moving our lead candidate MBS8 into the clinic was well supported, securing a clear path forward toward, and a smooth process for our Clinical Trial Application filed in the near future. Thanks to our consultants Ozack and Ingrid Bøgh for great help in the process.

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