On January 29, 2020 BerGenBio ASA (OSE: BGBIO) ("BerGenBio" or the "Company") reported a contemplated private placement of new shares in the Company (the "Private Placement") (Press release, BerGenBio, JAN 29, 2020, View Source;private-placement-successfully-placed-300995749.html [SID1234553669]).

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The Company is pleased to announce that the Private Placement has been successfully placed, raising gross proceeds of NOK 219,875,724 through the allocation of 12,215,318 new shares (the "Offer Shares") at a subscription price of NOK 18.00 per share (the "Subscription Price"). The Private Placement, that was over subscribed, took place through an accelerated book building process after close of market on 29 January 2020.

Arctic Securities AS and Carnegie AS acted as Joint Bookrunners and H.C. Wainwright & Co., LLC acted as Financial Advisor (together the "Managers") in connection with the Private Placement. The Private Placement attracted strong interest from existing shareholders and new institutional investors.

The Company intends to use the net proceeds from the Private Placement to continue advancing its clinical trial programs with its lead candidate bemcentinib in patients with Acute Myeloid Leukaemia (AML) and Non Small Cell Lung Cancer (NSCLC), manufacturing scale-up of bemcentinib, biomarker and companion diagnostic development, and phase 1b development of tilvestamab (formerly BGB149), as well as for general corporate purposes.

The completion of the Private Placement by delivery of Offer Shares to the applicants will be divided in two tranches. Applicants have been allocated Offer Shares in Tranche 1 and 2 on a pro-rata basis based on their overall allocation in the Private Placement, with the exception of Meteva AS which has agreed that Offer Shares allocated to it shall be delivered solely in Tranche 2. Tranche 1 consists of 5,475,136 Offer Shares ("Tranche 1") and the issuance of the Offer Shares in Tranche 1 was resolved by the Company’s board of directors at a board meeting held on 29 January 2020, based on the authorization granted to the board of directors at the Company’s annual general meeting held on 13 March 2019. Tranche 2 consists of 6,740,182 Offer Shares ("Tranche 2") and is subject to approval by the extraordinary general meeting of the Company to be held on 20 February 2020 (the "EGM") and the placement agreement entered into between the Company and the Managers not being terminated by the Managers in accordance with the terms thereof. The board of directors has resolved to summon an extraordinary general meeting to be held on 20 February 2020. If Tranche 2 is not completed (e.g. due to non-approval by the EGM), applicants will not be delivered Offer Shares in Tranche 2 and the Company will hence not receive the proceeds from Tranche 2.

Notification of allocation of the Offer Shares and payment instructions is expected to be sent to the applicants through a notification from the Managers on 30 January 2020.

The Offer Shares in Tranche 1 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 Meteva AS as lender, Arctic Securites AS (on behalf of the Managers) and the Company in order to facilitate delivery of listed shares in the Company to investors delivery versus payment on a T+2 basis. The shares in the Company delivered to the subscribers in Tranche 1 will thus be tradable immediately after delivery to the subscribers. Arctic Securities AS will settle the share loan with the Offer Shares in Tranche 1 once such shares are issued.

Following registration of the new share capital in the Company and issuance of the Offer Shares in Tranche 1 with the Norwegian Register of Business Enterprises, which is expected to take place on or about 5 February 2020, the Company will have an issued share capital of NOK 6,655,172.60 divided into 66,551,726 shares, each with a par value of NOK 0.10.

The Offer Shares in Tranche 2 will be settled after the extraordinary general meeting with existing and unencumbered shares in the Company that are already listed on the Oslo Stock Exchange, pursuant to a share lending agreement between Meteva AS as lender, Arctic Securites AS (on behalf of the Managers) and the Company in order to facilitate delivery of listed shares in the Company to investors on a delivery versus payment T+2 basis. The shares in the Company delivered to the subscribers in Tranche 2 will thus be tradable immediately after delivery to the subscribers. Arctic Securities AS will settle the share loan with the Offer Shares in Tranche 2 once such shares are issued. The Offer Shares re-delivered to Meteva AS in Tranche 2 will be issued on a separate ISIN and will not be tradable on Oslo Børs until a listing prospectus has been approved by the Norwegian Financial Supervisory Authority, expected late February 2020.

Following registration of the new share capital in the Company and the issuance of the Offer Shares in Tranche 2 with the Norwegian Register of Business Enterprises, which is expected to take place on or about 27 February 2020, the Company will have an issued share capital of NOK 7,329,190.80 divided into 73,291,908 shares, each with a par value of NOK 0.10.

The following primary insiders have been allocated Offer Shares in the Private Placement at a subscription price equal to the Subscription Price (with new holding of shares in the Company in brackets):

Meteva AS 3,291,750 (19,750,500)

Gnist Holding AS (Richard Godfrey) 5,556 (221,005)

Completion of the Private Placement implies a deviation from the existing shareholders’ pre-emptive rights to subscribe for and be allocated new shares. The board of directors of the Company has carefully considered such deviation and has resolved that the Private Placement is in the best interests of the Company and its shareholders. In reaching this conclusion the board of directors has inter alia considered the implications of an underwritten rights issue given the volatility and negative development in the Company’s share price, alternative financing sources, the dilutive effect of the share issue, the Company’s need for additional liquidity and Subscription Price.

Subject to prevailing market price of the Company’s shares being higher than the Subscription Price in a period determined by the board of directors in its sole discretion, the Company will carry out a subsequent offering of up to 1,500,000 new shares towards shareholders in the Company as of 29 January 2020 (as registered in the Norwegian Central Securities Depository ("VPS") on 31 January 2020), who (i) were not allocated shares in the Private Placement, and (ii) 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. If carried out, the subscription price in the subsequent offering will be the same as in the Private Placement and be conditional upon approval by the extraordinary general meeting of the Company to be held on 20 February 2020 and the approval of a listing and offering prospectus by the Norwegian Financial Supervisory Authority.

On January 29, 2020 CytRx Corporation (OTCQB: CYTR), a biopharmaceutical research and development company, reported that ImmunityBio, previously NantCell, Inc., and NantKwest announced a complete response in Metastatic Pancreatic Cancer in one patient who received its experimental Human Killer Cell combination Immunotherapy, which includes aldoxorubicin, in its Phase 1 clinical trial (Press release, CytRx, JAN 29, 2020, View Source [SID1234553671]). This result builds on the results released previously in patients with Triple Negative Breast Cancer ("TNBC"), in which two of nine patients treated with this experimental cancer therapy also had a complete response. These immunotherapies include CytRx’s aldoxorubicin as part of its innovative chemoradiation therapy. NantKwest also indicated they plan to initiate registration trials in recurrent metastatic TNBC and pancreatic cancer patients that failed standard of care.

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"We continue to be encouraged with the initial results of this promising protocol, which includes aldoxorubicin, in targeting two of the most difficult cancer types that patients have had challenges with," said Eric Curtis, President and Chief Operating Officer of CytRx.

CytRx out-licensed global development, manufacturing, and commercialization rights for aldoxorubicin to ImmunityBio Inc. in July 2017. CytRx has an agreement with ImmunityBio that will pay CytRx up to $343 million in milestones, plus single and double-digit royalties on aldoxorubicin.

On January 28, 2020 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it was recently named as a Top Company for Corporate Responsibility practices by both Newsweek and Investor’s Business Daily (Press release, West Pharmaceutical Services, JAN 28, 2020, View Source [SID1234553621]).

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Newsweek has named West to its America’s Most Responsible Companies 2020 list. Newsweek’s partner, Statista Inc., who conducted the analysis, focused on areas such as Leadership Diversity, Employees and Philanthropy & Engagement as well as making a difference in local communities. After examining the top 2,000 public companies (by revenue), West was ranked #166 overall as among the "most committed to Corporate Responsibility" and was ranked in the Top 20 among companies in the Health Care & Life Sciences industry. West also ranked #9 overall for companies headquartered in Pennsylvania.

West is also honored to have been ranked #19 on Investor’s Business Daily’s 50 Best ESG Companies list. This recognition honors companies with strong financial performance that hold true to their ESG (environmental, social and governance) values. Among companies with ESG ratings of AAA or AA from MSCI ESG Research as of September 11, 2019, the top 50 recognized companies earned the highest IBD Composite Ratings, which is a marker of strong stock growth. West was ranked #3 in the Health Care sector.

"We are honored that West has been recognized for our Corporate Responsibility initiatives by these two publications," shared Steve Walton, VP, HSE & Corporate Responsibility. "This recognition is a testament to the great work our team members are doing to make their communities and the world a better place. I’m excited to keep the momentum going as we push forward with a continued focus and commitment into 2020 and beyond."

In addition to this Top Companies recognition, over the past year West has received several additional CR focused awards, recognizing the global efforts of the Company and its team members. These awards include: the CSR Initiative Award and Corporate Social Responsibility Programme of the Year Award, both presented to West’s Dublin, Ireland site; the Goodwill Employer of the Year Award, presented to West’s Kearney, NE site; the West Chester University Corporate President’s Award; and the Philadelphia Business Journal’s Faces of Philanthropy distinction.

West’s award-winning Corporate Responsibility Program is committed to nurturing a culture of diversity and inclusion and supporting the communities in which its team members live and work. One major element of the Program is West’s culture of giving. West targets its global philanthropic efforts to support children, people with disabilities, healthcare and education, with a focus on STEM. Health and Safety is also a key focus area, as West is committed to designing and operating its facilities to provide a healthy and safe workplace. In addition, environmental considerations are taken into account for every aspect of West’s business, and its Sustainability Program targets reductions in areas where West can make the greatest difference: greenhouse gas emissions, waste, energy and water usage, and increased recycling.

On January 28, 2020 Sysmex Group Company reported that Pathologist Dr. Vincente Peg of the Vall d´Hebron University Hospital (Barcelona Spain) and colleagues have presented a correlation between the clearance of circulating tumor DNA (ctDNA) in HER2-positive or triple-negative breast cancer patients undergoing neoadjuvant treatment with a clinical/pathologic complete response at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Advances in Liquid Biopsies conference held in Miami, Florida (USA), January 13-16, 2020 (Press release, Sysmex Inostics, JAN 28, 2020, View Source [SID1234553637]). The researchers utilized both a SureSeq NGS cancer gene enrichment panel (Oxford Gene Technology, a Sysmex Group Company) for identifying lead mutations from breast cancer FFPE tissue, and Sysmex Inostics’ SafeSEQ personalized liquid biopsy platform for patient-specific longitudinal analysis of plasma ctDNA.

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Neoadjuvant therapy to reduce tumor size prior to surgical resection is common in the treatment of early stage breast cancer. However, there exists an unmet clinical need to distinguish those patients with residual disease after Neoadjuvant Therapy (NAT) from those who achieved complete response in order to better understand which patients are appropriately suited for surgery. Researchers from Vall d´Hebron deployed SureSeq NGS testing to identify driver mutations in breast cancer biopsy tissue of 29 patients with early stage disease. The mutations detected with SureSeq were subsequently followed in the plasma of patients with the SafeSEQ ultrasensitive personalized ctDNA platform to complement radiographic assessment and provide more detailed information on an individual’s response to NAT.

Of 29 Stage II and Stage III triple-negative and HER2-positive breast cancer patients examined in the study, 20 (69%) had TP53 or PIK3CA tissue mutations identified by SureSeq with 17 out of 20 (85%) patients having detectable mutations with SafeSEQ in plasma samples prior to initiation of NAT. Longitudinal plasma analysis conducted at treatment mid-point and post-treatment immediately prior to surgery demonstrated the absence of ctDNA following NAT was observed in all patients (12/12) showing a complete clinical response. However, ctDNA was detected in 3 out of 5 (60%) of patients who did not achieve complete clinical response suggesting that ctDNA testing – alongside of imaging – is an important clinical parameter to consider when determining complete response to neoadjuvant treatment.

"This study addresses the unmet need to de-escalate surgery in patients with no sign of disease." Dr. Vicente Peg commented. "How can we avoid surgically removing something that is just not there? Circulating tumor DNA by itself is able to detect 85% of patients that achieve pathologic complete response; however, when combined with imaging we can identify 100% of patients. These findings are an important first step to showing that we can accurately identify those patients who may avoid unnecessary surgery."

Reference:
Ciriaco, N., Zamora, E. and Peg, V. et al. AACR (Free AACR Whitepaper) Advances in Liquid Biopsy Conference 2020 Poster session B January 15, 2020. Clearance of ctDNA in triple-negative and HER2-positive breast cancer patients during neoadjuvant treatment is correlated with pathological complete responses, Poster B63.

On January 28, 2020 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported the appointment of Dr. Laurence De Moerlooze to the position of Executive Vice President and Chief Medical Officer (CMO) (Press release, Bavarian Nordic, JAN 28, 2020, View Source [SID1234553622]). Dr. De Moerlooze joins Bavarian Nordic from Takeda Vaccines, where she has served since 2017 as Vice President and Global Program Lead for vaccines against Zika virus and Norovirus.

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Prior to joining Takeda, she worked at GlaxoSmithKline (GSK) for more than 15 years, holding various leading roles in medical affairs and vaccine development working with numerous life-saving vaccines including Rabipur/Rabavert and Encepur.

Dr. De Moerlooze will take up the position in April 2020.

"I am pleased to welcome Laurence to Bavarian Nordic and to our executive team. Laurence brings a wealth of knowledge from the vaccine industry and will add important and valuable R&D and commercial experience to our company as we continue to expand our business," said Paul Chaplin, President and CEO of Bavarian Nordic.

"I am delighted to join Bavarian Nordic at such a key time for the Company. I look forward to putting my experience and commitment to the service of the organization in the development of life-saving vaccines and immunotherapies. I am also eager to help bring the newly acquired rabies and tick-borne encephalitis vaccines to patients who need them most," said Laurence De Moerlooze.