On March 10, 2021 KSQ Therapeutics, a biotechnology company using its proprietary CRISPRomics discovery platform to systematically screen the whole genome to identify optimal gene targets for oncology and autoimmune disease, reported that the company is scheduled to present at the Oppenheimer 31st Annual Healthcare Conference, to be held virtually, on Tuesday, March 16th, 2021, at 4:30 p.m. ET (Press release, KSQ Therapeutics, MAR 10, 2021, View Source [SID1234576420]).

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On March 10, 2021 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported the expansion of a randomized, controlled study with TG4001 in combination with avelumab versus avelumab monotherapy in patients with HPV16-positive anogenital tumors (NCT: 03260023) (Press release, Transgene, MAR 10, 2021, View Source [SID1234576419]).

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Transgene has amended the initial Phase Ib/II trial protocol to enable a more rapid start of this important Phase II study based on encouraging Phase Ib/II trial data. This randomized Phase II trial will be supported by a continuing collaboration with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab. Transgene retains all rights to TG4001.

PHASE II TRIAL AIMS TO SHOW THE SUPERIORITY OF TG4001 + AVELUMAB OVER AVELUMAB MONOTHERAPY

The initial Phase Ib/II trial conducted in Europe (France and Spain) has been amended to include a randomized comparison of the combination of TG4001 with avelumab versus avelumab monotherapy in anogenital cancers. The submission of the amended protocol has been initiated in Europe. In addition, Transgene received US FDA clearance of the protocol under TG4001 IND. Patient enrollment is expected to start in Q2 2021.

The trial will focus on patients with recurrent or metastatic HPV16-positive anogenital cancer without liver metastases, including cervical, vulvar, vaginal, penile, and anal cancer. This population was shown in the Phase Ib/II study to derive improved clinical benefit from the combination regimen [1, 2].

Patients will be randomized to either receive the combination regimen of the therapeutic vaccine TG4001 and avelumab or avelumab alone.

The primary endpoint of the trial is progression-free survival (PFS) according to RECIST 1.1. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS) and a series of immunological parameters.

The Phase II trial will be supported by the extension of the collaboration with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab for this trial. Transgene retains all rights to TG4001.

An interim analysis will be performed after the enrollment of nearly 50 patients. Transgene expects to communicate the interim analysis data around the end of 2022. This timeline is based on patient enrollment starting in Q2 2021 and there being no major impact on recruitment from the Covid-19 pandemic.

Commenting on this novel investigational immunotherapy regimen, Prof. Christophe Le Tourneau, MD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute and Principal Investigator of the trial, added: "I am very pleased that we are now moving ahead with a new part of this Phase II study. The promising data that we generated in the Phase Ib/II part of this study, in patients without liver metastases, gives me confidence that the amended study can generate the additional data needed to confirm the treatment benefits of the combination of TG4001 and avelumab in this patient population with very limited therapeutic options."

RECURRENT AND METASTATIC HPV16-POSITIVE ANOGENITAL CANCERS NEED BETTER TREATMENT OPTIONS

The Phase II trial focuses on indications where standard therapeutic options and immune checkpoint inhibitors have limited efficacy. These indications represent areas of important medical need; they include cervical, vulvar, vaginal, penile, and anal cancer. The trial will enroll patients who have received a maximum of one line of chemotherapy for the treatment of their recurrent or metastatic disease or who are not eligible for chemotherapy.

Transgene estimates the number of people diagnosed annually with these cancers to be around 25,000 patients per year (US, Europe 27, UK) [3-9]. In spite of recent progress, patients with these severe and heterogeneous malignancies need better treatment options, particularly after the recurrence of the disease: median overall survival is less than 11 months [10-13] and median progression-free survival is around 2 months [10-13].

Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene, concludes about this study: "I am pleased we have been able to use a methodologically sound trial design to move ahead with this randomized Phase II study quickly. The results from the initial Phase Ib/II study demonstrated the potential of the combination of TG4001 with an immune checkpoint inhibitor in this advanced disease setting. We observed encouraging clinical outcomes with a response rate reaching 34.8% and median progression-free survival of 5.6 months in patients without liver metastases. The observed median progression-free survival shows that this combination can induce a sustained and durable benefit, which may be based on the induction of a specific immune response. This study is expected to provide us with the data required to discuss the registration path of TG4001."

About the trial
The multi-center, open label, randomized Phase II trial (NCT03260023) is designed to compare the efficacy of the combination of TG4001 and avelumab versus avelumab alone in patients with advanced, recurrent and/or metastatic HPV16-positive anogenital cancers who have disease progression after a maximum of one line of systemic treatment, or who are not eligible for first-line chemotherapy.

Prof. Christophe Le Tourneau, M.D., PhD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute, is the Principal Investigator of the study. The trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE), which are providing avelumab for the trial. Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. Transgene will continue to be the sponsor of the trial and conduct the trial.

Patients will receive TG4001 at the dose of 5×107 pfu, SC, weekly for 6 weeks, every 2 weeks up to six months, and every 12 weeks thereafter, in combination with avelumab or avelumab alone at 800 mg, IV every two weeks, until disease progression. The primary endpoint of the trial is progression-free survival (PFS) according to RECIST 1.1. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS) and other immunological parameters. The trial could enroll up to 136 patients until the final analysis.

Patients with liver metastases will be followed in an ancillary arm and will be randomized to receive one of the treatment regimens; these patients will not be included in endpoint analyses.

About the data presented at SITC (Free SITC Whitepaper) 2020 and ESMO (Free ESMO Whitepaper) IO 2020 [1,2]
The results from the Phase Ib/II parts of the trial combining TG4001 with avelumab in HPV16-positive recurrent and/or metastatic malignancies were presented at SITC (Free SITC Whitepaper) 2020 [1] and ESMO (Free ESMO Whitepaper) IO 2020[2].

The combination of TG4001 and avelumab demonstrated anti-tumor activity (23.5% ORR) in patients with previously treated recurrent and/or metastatic HPV-related cancers (including patients with oropharyngeal cancers and anogenital cancers). Presence of liver metastases had a profound impact on the outcome in terms of ORR and PFS. In patients without liver metastases, an ORR of 34.8% and a median PFS of 5.6 months were achieved. The treatment induced HPV-specific T-cell responses and was associated with increased levels of immune cell infiltration in the tumors and expression of genes associated with activation of the immune system.

About TG4001
TG4001 is an investigational therapeutic vaccine based on a non-propagative, highly attenuated Vaccinia vector (MVA), which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2). TG4001 is designed to have a two-pronged antiviral approach: to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens, that can be found in HPV16-related tumors, and to further stimulate the infection-clearing activity of the immune system through interleukin 2 (IL-2). TG4001 has been administered to more than 300 individuals, demonstrating good safety and promising efficacy results [1, 2, 14, 15]. Its mechanism of action and good safety profile make TG4001 an excellent candidate for combinations with other therapies in HPV-mediated solid tumors.

About HPV-Positive Cancers
HPV-positive cancers comprise a variety of malignancies, including anogenital cancers [3]. HPV-positive cancers include cervical [4], vaginal [5], vulvar [6], anal [7] and penile [8] cancers, i.e., approximately 25,000 cancers at metastatic stage eligible for a first-line treatment and in second line for a locoregional disease [9] (USA, EU 27, UK).

Current treatments mostly include chemoradiotherapy. However, better options are needed for advanced and metastatic HPV-positive cancers. It is thought that a therapeutic vaccine combined with other immunotherapeutic agents such as immune checkpoint inhibitors (ICIs) could provide a promising potential treatment option that would address this strong medical need [16,17]. With immune checkpoint inhibitors, median overall survival remains less than 11 months [10-13] and median progression-free survival is between 2 and 4 months [10-13].

On March 10, 2021 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its financial results for 2020 and provides an update on its product pipeline (Press release, Transgene, MAR 10, 2021, View Source [SID1234576418]).

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Hedi Ben Brahim, Chairman and Chief Executive Officer of Transgene since January 1, 2021, commented:

"It is a great honor to join Transgene as Chairman and Chief Executive Officer at the beginning of 2021, taking over from Philippe Archinard. Over the last several months, Transgene has delivered multiple significant milestones, particularly from our new cutting-edge platforms myvac and Invir.IO as we have continued to operate successfully despite the Covid-19 pandemic.

We treated the first patients with TG4050, our individualized immunotherapy based on the myvac technology. This achievement illustrates how Transgene is positioning itself at the forefront of innovation globally by developing new solutions that could deliver important benefits for patients, clinicians and potential pharmaceutical partners. This customized immunotherapy is particularly promising, and I look forward to reporting the first data from TG4050 in the fourth quarter of 2021.

The very encouraging results with TG4001 which we announced in 2H 2020, have allowed us to rapidly initiate a Phase II randomized trial. The protocol of this study has already been approved in the U.S. and we expect patient inclusion to start in the coming months, with the aim of providing the first clinical results around the end of 2022.

This acceleration of our development is also reflected in the progress we made with BT-001, the first oncolytic virus of our Invir.IO platform to enter the clinic and supported by a very exciting preclinical data set. We have also seen another clinical oncolytic virus candidate TG6002 advance and deliver first promising translational data.

With financial visibility until 2022, we have the funds needed to deliver the important clinical results we expect in 2021 and 2022. Our strategy aims to leverage Transgene’s exciting new drug candidates, notably through large-scale partnerships, to generate significant value for our shareholders. I am very confident that the globally competitive product pipeline that we have today will allow us to deliver on our ambitious goals."

GLOBAL TECHNOLOGY LEADERSHIP WITH THE MYVAC PLATFORM AND THE THERAPEUTIC VACCINE TG4050

Transgene is developing an individualized immunotherapy based on multiple advanced genetic engineering technologies that have been developed by the company. TG4050 is the first drug candidate based on the myvac platform. Together with NEC, Transgene has set up a customized approach that combines its expertise in viral engineering with NEC’s artificial intelligence capabilities. NEC’s algorithms enable the customization of the treatment for each patient, by indicating the most relevant targets (patient-specific neoantigens).

The Phase I clinical trials assessing TG4050 started in January 2020 in Europe and in the United States. The first patients have been treated in these two clinical trials (ovarian and oropharyngeal cancers). NEC is financing 50% of these studies. The first data are expected in the fourth quarter of 2021.

The Company has set up an in-house production unit dedicated to the manufacturing of the individualized clinical batches of TG4050 needed for each patient. This unit is operational and complies with good manufacturing practice (GMP) norms.

The myvac platform integrates leading-edge innovations that are based on Transgene’s technological leadership in individualized immunotherapies.

Data validating the vaccine design principle and the underlining accuracy of the algorithm and AI used to personalize TG4050 were presented at the AACR (Free AACR Whitepaper) congress (June 2020).
Transgene has implemented the first block chain solution dedicated to the traceability of this personalized treatment in clinical trials. This solution monitors and orchestrates all of the processes related to the design and manufacturing of Transgene’s individualized therapeutic vaccine TG4050.
Transgene has set up a translational research program that includes a number of very innovative genomic and transcriptomic analyses. The goal is to characterize the effect of the treatment and identify predictors of response to TG4050 in the tumor and the genome environment that may impact each patient’s response to the vaccine. These data are important as they could lead to an optimized and accelerated development pathway for TG4050.
RANDOMIZED PHASE II TRIAL OF TG4001
IN HPV16-POSITIVE ANOGENITAL CANCERS TO START,
BASED ON PROMISING INITIAL DATA FROM PHASE IB/II

Transgene has amended the initial Phase Ib/II trial protocol to allow the more rapid start of this randomized Phase II study comparing the efficacy of TG4001 + avelumab versus avelumab monotherapy. This trial will be supported by a continuing collaboration with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab. Transgene retains all rights to TG4001.

The trial will focus on patients with recurrent or metastatic HPV16-positive anogenital cancer without liver metastases. This patient population, without liver metastases, was shown in the Phase Ib/II study to derive improved clinical benefit from the combination regimen.

In spite of recent progress, median overall survival is less than 11 months with chemotherapy and immune checkpoint inhibitors. The 25,000 patients who are diagnosed with these diseases every year (U.S., Europe 27, UK) with these HPV16-positive malignancies still need better treatment options.

Transgene received U.S. FDA clearance of the revised protocol under an IND for TG4001. The submission of the amended protocol has been initiated in Europe (France and Spain) where clinical sites that participated in the Phase Ib/II part study are ready to resume patient inclusion after regulatory approval. Patient enrollment is expected to start in 2Q 2021.

Transgene expects to communicate the interim analysis data around the end of 2022. This timeline is based on patient enrollment starting in 2Q 2021 and there being no major impact on recruitment from the Covid-19 pandemic.

Transgene today issued a press release providing more background on this TG4001 trial.

BT-001, THE FIRST ONCOLYTIC VIRUS BASED ON INVIR.IO, HAS ENTERED THE CLINIC AND FIRST OBSERVATIONS FROM TG6002 CONFIRM THE POTENTIAL OF OUR NEXT-GENERATION ONCOLYTIC VIRUSES

BT-001 is a patented VVcopTK-RR- oncolytic virus, with high antitumor potential, based on the Invir.IO platform. It is being co-developed with BioInvent. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. In addition, delivering the anti-CTLA4 antibody directly to the tumor microenvironment aims to induce local Treg depletion and strong therapeutic activity. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA4 antibody should be greatly improved. Promising preclinical results for BT-001 were presented at the AACR (Free AACR Whitepaper) and SITC (Free SITC Whitepaper) annual congresses (June and Nov. 2020). A Phase I/IIa trial targeting solid tumors has started in France and Belgium at the beginning of 2021.

Initial data from the Phase I trial of TG6002 confirm the good tolerability of TG6002 and demonstrate that this Vaccinia Virus, which is the same viral backbone on which the Invir.IO platform is based, can reach the tumor, replicate within these cancer cells and induce the production of 5-FU when administered intravenously.
These data will be detailed at the upcoming meeting of the AACR (Free AACR Whitepaper) (April 2021).

By developing the administration of TG6002 via the intravenous and intrahepatic artery routes, Transgene aims to enlarge the number of solid tumors that could be addressed by an oncolytic virus. This includes gastrointestinal tumors that are being investigated with TG6002. To-date, the oncolytic virus that has received regulatory approval has to be given via intra-tumoral administration, restricting its use to easily accessible tumors.

Our collaboration with AstraZeneca continues to develop new innovative oncolytic viruses. AstraZeneca can exercise an option to further develop each of these novel drug candidates in the clinic.

SUMMARY OF ONGOING CLINICAL TRIALS

myvac

TG4050

Phase I

NCT03839524

Targets: tumor neoantigens

✓ Data demonstrating the high accuracy of AI-based neoantigen prediction technology used to design TG4050 were presented at AACR (Free AACR Whitepaper) 2020

Ovarian cancer – after surgery and first-line chemotherapy

✓ Trial ongoing in the United States and in France

✓ First patient treated in 2020 – patient enrollment progressing in line with forecast

> First data expected in 4Q 2021

TG4050

Phase I

NCT04183166

HPV-negative head and neck cancer – after surgery and adjuvant therapy

✓ Trial ongoing in the United Kingdom and in France

✓ First patient treated in Jan. 2021 – patient enrollment progressing in line with forecast

> First data expected in 4Q 2021

TG4001

+ avelumab
Phase II

NCT03260023

Targets: HPV16 E6 and E7 oncoproteins

Recurrent/metastatic anogenital HPV-positive – 1st and 2nd line

✓ Continued clinical collaboration with Merck KGaA and Pfizer, for the supply of avelumab

✓ Promising Phase Ib/II results presented at SITC (Free SITC Whitepaper) and ESMO (Free ESMO Whitepaper) IO 2020

✓ A randomized Phase II trial comparing the efficacy of TG4001 + avelumab vs avelumab monotherapy has received U.S. FDA clearance. In Europe, the amended protocol has been submitted to French and Spanish health authorities

> Patient enrollment in the randomized trial expected to start in 2Q 2021

> First data from the randomized trial are expected around the end of 2022. This timeline is based on patient enrollment starting in 2Q 2021 and there being no major impact on recruitment from the Covid-19 pandemic.

Invir.IO

BT-001

Phase I/IIa

Payload: anti-CTLA4 antibody and GM-CSF cytokine

Solid tumors

✓ Co-development with BioInvent

✓ Presentation of very encouraging preclinical results at AACR (Free AACR Whitepaper) and SITC (Free SITC Whitepaper) 2020

✓ Trial authorized. Phase I ongoing in France and Belgium

✓ First patient enrolled in February 2021

> First Phase I data expected in 1H 2022

TG6002

Phase I/IIa

NCT03724071

Payload: FCU1 for the local production of a 5-FU chemotherapy

Gastro-intestinal cancer (colorectal cancer for Phase II) – Intravenous (IV) administration

✓ Multicenter trial ongoing in Belgium, France and Spain

✓ First findings confirm that 5-FU is produced in the tumor (Sept. 2020)

> Phase I part ongoing

> A poster on the first Phase I observations has been accepted at AACR (Free AACR Whitepaper) 2021

TG6002

Phase I/IIa

NCT04194034

Colorectal cancer with liver metastasis – Intrahepatic artery (IHA) administration

✓ Multicenter trial ongoing in the United Kingdom

✓ First patient treated in February 2020; enrollment resumed in September 2020 after pausing due to Covid-19

> First observations expected in 3Q 2021

KEY FINANCIALS FOR 2020

– Operating income of €9.9 million in 2020, compared to €13.7 million in 2019.
R&D services for third parties amounted to €3.0 million in 2020 (€6.7 million in 2019), mainly due to the collaboration with AstraZeneca, which generated €2.9 million in revenues in 2020. The research tax credit reached €6.3 million in 2020 (€6.5 million in 2019).

– Net operating expenses of €33.9 million in 2020, compared to €39.2 million in 2019.
R&D expenses were €27.3 million in 2020 (€31.4 million in 2019) with the reduction due to lower clinical trial expenses in 2020 and to the decrease of external expenses related to the manufacturing of clinical batches.
General and administrative expenses amounted to €6.5 million in 2020 (€7.1 million in 2019).

– Financial income of €6.8 million in 2020, compared to €6.7 million in 2019.
The partial sale of the Tasly BioPharmaceuticals shares in July 2020 generated a net gain on asset disposal of €2.7 million. Transgene’s remaining shareholding was revalued and resulted in financial income of €6.4 million in 2020. This figure corresponds to the difference between the market price and the historical price.

– Net loss of €17.2 million in 2020, compared to €18.8 million in 2019.

– Cash burn reduced to €17.0 million in 2020, versus €20.5 million in 2019 (excluding capital increase).
The net cash inflow of €18.2 million from the sale of Tasly BioPharmaceuticals shares in July 2020 reduced net cash consumption compared to 2019. This transaction enabled the Company to reimburse in advance the €10 million bank loan from the European Investment Bank (EIB) in October 2020 (against an initial maturity scheduled for this loan of June 2021).

– Cash available at year-end 2020: €26.3 million, compared to €43.3 million at the end of 2019. In addition, Transgene still has access to a credit line of €15 million and holds Tasly BioPharmaceuticals shares valued at €32.3 million at the end of December 2020.

– As a result, Transgene has a financial visibility until 2022.

HEDI BEN BRAHIM APPOINTED CHAIRMAN AND CHIEF EXECUTIVE OFFICER

Hedi Ben Brahim was appointed as the Company’s Chairman and CEO, effective January 1, 2021. He has been a member of Transgene’s Board since May 2019. Hedi Ben Brahim replaces Philippe Archinard, who had led the company since 2005 and who remains a member of the Board of Transgene.

The financial statements for 2020 as well as management’s discussion and analysis are attached to this press release (Appendices A and B).

The Board of Directors of Transgene met on March 10, 2021, under the chairmanship of Hedi Ben Brahim and closed the 2020 financial statements. Audit procedures have been performed by the statutory auditors and the delivery of the auditors’ report is ongoing.

The Company’s universal registration document, which includes the annual financial report, will be available early April 2021 on Transgene’s website, www.transgene.fr.

On March 10, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that its Chief Executive Officer Saiid Zarrabian will participate in Maxim Group’s 2021 Emerging Growth Virtual Conference taking place March 17-18, 2021 (Press release, Kintara Therapeutics, MAR 10, 2021, View Source [SID1234576417]). Mr. Zarrabian will be a speaker on a panel discussing glioblastoma and, more specifically, chemo-based and/or DNA repair target solutions.

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Investors can view Mr. Zarrabian’s panel participation at 9:30 am ET on March 17, 2021 once they register for the conference here, and an archived replay of the panel discussion will be available on the conference website. Investors can also request a 1×1 meeting with Mr. Zarrabian to be arranged following the conclusion of the conference.

On March 10, 2021 Bavarian Nordic A/S ("Bavarian Nordic" or the "Company") reported its intention to raise new capital through an accelerated bookbuilding process (Press release, Bavarian Nordic, MAR 10, 2021, View Source [SID1234576416]). The offering (the "Offering") of new shares in Bavarian Nordic has now been successfully completed. Reference is made to company announcement no. 4 of 9 March 2021.

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Bavarian Nordic has successfully completed a directed issue and private placement of 5,150,000 new shares (the "New Shares") at an offer price of DKK 223 per share, raising gross proceeds to Bavarian Nordic of DKK 1,148.45 million.

The Offering has not been registered under the U.S. Securities Act and was made pursuant to applicable exemptions from the obligation to publish a prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions in a directed issue and private placement and subscribed for by eligible institutional and professional investors in Denmark and in certain other jurisdictions at market price and without pre-emption rights for Bavarian Nordic’s existing shareholders.

The net proceeds from the Offering will be used in accordance with company announcement no. 4 of 9 March 2021.

Bavarian Nordic has in connection with the Offering, agreed to undertake a lock-up commitment for 180 calendar days following settlement of the Offering (subject to certain exceptions). In addition, members of Bavarian Nordic’s board of directors and executive management have in connection with the Offering, agreed to undertake a lock-up commitment for 90 calendar days following settlement of the Offering (subject to certain exceptions).

CAPITAL INCREASE
Subject to settlement, a share capital increase will be registered with the Danish Business Authority and the share capital of Bavarian Nordic will hereafter consist of 63,600,112 shares of DKK 10 each, equivalent to a registered share capital of DKK 636,001,120.

The New Shares represent approximately 8.81 % of Bavarian Nordic’s registered share capital before the capital increase and will account for approximately 8.1 % of Bavarian Nordic’s registered share capital upon completion of the capital increase.

ADMISSION TO TRADING AND OFFICIAL LISTING
The New Shares will be issued under the temporary ISIN code DK0061535853. No application for admission to trading and official listing has been, or will be, filed for the New Shares issued under the temporary ISIN code, and the temporary ISIN code will only be registered with VP Securities A/S for subscription of the New Shares. The temporary ISIN code in VP Securities A/S will be merged with the permanent ISIN code for the existing shares, DK0015998017, as soon as possible following registration of the share capital increase with the Danish Business Authority. The New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen A/S on or around 15 March 2021.

The admission to trading and official listing of the New Shares is subject to the Offering not being withdrawn prior to the settlement of the Offering and the Company making an announcement to that effect.

EXPECTED TIMETABLE FOR THE OFFERING

Date Event
Friday 12 March 2021 Settlement and payment for the New Shares
Friday 12 March 2021 Registration of the capital increase with the Danish Business Authority
Monday 15 March 2021 Admission to trading and official listing of the New Shares on Nasdaq Copenhagen A/S
Tuesday 16 March 2021 Merger of the temporary ISIN code with the permanent ISIN code
NEW SHARES
The decision to launch an offering of new shares in a directed issue was made pursuant to Article 5a(2) in Bavarian Nordic’s articles of association pursuant to which its board of directors is authorised to make share capital increases without pre-emption rights for the existing shareholders at market price.

The New Shares will rank pari passu in all respects with existing shares in Bavarian Nordic. The New Shares will be negotiable instruments, and no restrictions will apply to their transferability. No shares, including the New Shares, carry or will carry any special rights. Rights conferred by the New Shares, including voting rights and dividend rights, will apply from the time when the capital increase is registered with the Danish Business Authority. The New Shares must be registered in the name of the holder in the Company’s register of shareholders.

MANAGERS
Danske Bank A/S, Jefferies International Limited, Jefferies GmbH and Nordea Danmark, filial af Nordea Bank Abp, Finland are acting as Joint Global Coordinators and Joint Bookrunners (jointly the "Joint Global Coordinators and Joint Bookrunners") in connection with the Offering. Nordea Danmark, filial af Nordea Bank Abp, Finland acts as settlement agent for the Offering.

Kromann Reumert and Latham & Watkins LLP act as Danish and U.S. legal advisors respectively to the Company. Plesner acts as Danish legal advisors to the Joint Global Coordinators and Joint Bookrunners.