Incyte Announces Data from Multiple Programs Within its Oncology Portfolio Accepted for Presentation at the AACR Annual Meeting 2021

On March 11, 2021 Incyte (Nasdaq:INCY) reported that multiple abstracts from across its oncology portfolio will be presented during Week 1 of the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, held virtually from April 10-15, 2021 (Press release, Incyte, MAR 11, 2021, View Source [SID1234576453]).

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"At AACR (Free AACR Whitepaper) 2021, we look forward to sharing clinical and pre-clinical data from INCB106385, our novel A2A/A2B adenosine receptor antagonist, and INCA00186, our novel CD73 monoclonal antibody—both of which highlight our ongoing efforts targeting the adenosine pathway. Presentations at the congress will also feature updated data from our LIMBER development program, including results from our Phase 2 combination study of ruxolitinib, a janus kinase (JAK1/JAK2) inhibitor, and parsaclisib, a potent, highly selective oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ)," said Steven Stein, M.D., Chief Medical Officer, Incyte, adding, "We further look forward to sharing clinical and pre-clinical data on these and other targeted and immuno-oncology therapies in the Incyte portfolio."

Key abstracts from Incyte-sponsored and partner programs include:

Targeted Therapy

Addition of Parsaclisib (INCB050465), a PI3Kδ Inhibitor, in Patients with Suboptimal Response to Ruxolitinib: A Phase 2 Study in Patients with Myelofibrosis (Abstract #CT162, Session: Phase II Clinical Trials.)

The LSD1 Inhibitor INCB059872 is a Possible Therapeutic Option for Venetoclax-Resistant AML (Abstract #1134, Session: Epigenetic Targets.)

Accurate Detection of MET Exon 14 Skipping Using Liquid Biopsy Assay in NSCLC Patients in the GEOMETRY Mono-1 Study 1 (Abstract # LB056, Session: Liquid Biopsies: Circulating DNA.)

Immuno-Oncology

Discovery and Preclinical Characterization of INCB106385, a Novel A2A/A2B Adenosine Receptor Antagonist, as a Cancer Immunotherapy (Abstract #LB157, Session: Immune Checkpoints.)

Discovery and Preclinical Characterization of INCA00186, a Humanized Monoclonal Antibody Antagonist of CD73, as a Cancer Immunotherapy (Abstract #LB174, Session: Therapeutic Antibodies, Including Engineered Antibodies.)

All presentation sessions will be available on demand beginning April 10, 2021 at 8:30 a.m. ET, through June 21, 2021. Full session details and listings for oral and e-poster presentations are available online via the AACR (Free AACR Whitepaper) 2021 program: View Source!/9325.

Transgene Expands Phase II Clinical Trial of Therapeutic Vaccine TG4001 in Combination With Avelumab Versus Avelumab Monotherapy in Patients With HPV16-positive Anogenital Cancers

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 [SID1234621820]).

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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].

Onxeo Launches a Rights Issue to accelerate its R&D programs

On March 10, 2021 Onxeo S.A. (Euronext Growth Paris: ALONX, First North Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, reported the launch of a capital increase through the issuance of new shares (the "New Shares") with shareholders’ preferential subscription rights (PSR) for a gross target amount of €9.3 million, which may be increased to €10.7 million through the exercise of the extension clause, at a price of €0.71 per share with a parity of 1 New Share for 6 existing shares (the "Right Issue) (the "Capital Increase") (Press release, Onxeo, MAR 10, 2021, View Source [SID1234580413]). The prospectus relating to the Rights Issue (the "Prospectus") has received approval no. 21-063 dated March 9, 2021 from the Autorité des marchés financiers ("the AMF").

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The proceeds from this issue of New Shares will be used to finance primarily the expansion and acceleration of the clinical development of AsiDNA, in particular in combination with other anti-cancer agents.

The Company also intends to:

continue the optimization and preclinical development of new candidates selected on the platON platform,
optimize pharmaceutical development and compound manufacturing operations, and
more generally, finance the Company’s operations.
Judith Greciet, Chief Executive Officer of Onxeo stated: "Our key asset, AsiDNA, is currently in clinical development in two ongoing trials. DRIIV-1b aims at showing an increased efficacy of reference chemotherapy treatments combined with AsiDNA in solid tumors while Revocan has been designed to demonstrate the ability of AsiDNA to overcome tumor resistance to targeted therapies such as a PARP inhibitor. With this new financing, our goal is to accelerate the clinical development of AsiDNA in the coming months and initiate additional trials to unlock the potential of this first-in-class candidate. A randomized Phase 2 study of AsiDNA in combination with platinum-based chemotherapies in a high medical need indication is already in preparation and should soon be followed by other proof-of-concept clinical trials. The raised amount will also support the optimization of a second candidate issued from our chemistry platform platON, as well as our activities related to pharmaceutical development and manufacturing operations.

We would like to warmly thank our two core shareholders, Financière de la Montagne and Invus, who are once again demonstrating their confidence in our long-term development strategy, as well as other shareholders who will support our acceleration plan through their participation in this operation. This capital raise will enable the Company to extend its financial visibility until the 4th quarter of 2022, taking into account the new preclinical and clinical programs that the Company intends to conduct as early as 2021 to accelerate its development."

EVOLUTION OF R&D PROGRAMS

The Prospectus in section 3 of the Amendment (page 13 & following) and in section 2 of the summary of the Securities note (pages 5 & 6) provides updated and enriched information on Onxeo’s programs under development (studies in progress, studies planned in the short term) and its strategy, as an extension of the information communicated to the market, including the letter to shareholders dated February 2, 2021.

MAIN TERMS AND CONDITIONS OF THE RIGHTS ISSUE

Nature of the operation

The fund raising proposed by Onxeo is a capital increase through the issuance of New Shares with preferential subscription rights (PSR). Prior to the proposed transaction, Onxeo’s share capital amounted to €19,579,452.50 divided into 78,317,810 shares with a par value of €0.25 each.

The operation will involve the issue of a maximum of 15,010,913 New Shares (in case of exercise of the extension clause) at a unit price of €0.71, on the basis of 1 New Share for 6 existing shares owned: 6 preferential subscription rights will allow to subscribe to 1 New Share. Each shareholder will receive one preferential subscription right for each share registered in his securities account at the end of the accounting day of March 16, 2021, according to the indicative timetable set out below.

The offering will be open to the public in France and Denmark only.

Share codes

Name: Onxeo

ISIN Code: FR0010095596

Listing locations: Euronext Growth Paris and Nasdaq First North Growth Copenhagen

Ticker Euronext Growth Paris: ALONX

Ticker Nasdaq First North Growth Copenhagen: ONXEO

LEI Code: 96950018AS30IUG0V528

Contributors

Invest Securities is acting as Lead Manager and Bookrunner for the transaction.
Invest Corporate Finance will act as Listing Sponsor.
Nordea Denmark, a subsidiary of Nordea Bank Abp, Finland, will act as Underwriting Agent in Denmark.
Legal framework of the offer

Pursuant to the delegation received under the 17th and 20th resolutions adopted by the Extraordinary Shareholders’ Meeting of June 19, 2020, the Board of Directors’ meeting of January 20, 2021, decided, inter alia:

the principle of a capital increase with preferential subscription rights, and
to sub-delegate the effective implementation of this resolution to the Chief Executive Officer of the Company, who decided on March 9, 2021 to implement the sub-delegation granted to him and to proceed with a capital increase by issuing New Shares with preferential subscription rights, under the following conditions:
Subscription price of the New Shares

The subscription price was set at 0.71 euro per share, including 0.25 euro par value and 0.46 euro additional paid-in capital to be fully paid up at the time of subscription, representing a 5.3% face discount compared to the closing price of Onxeo shares on March 8, 2021, i.e. 0.75 euro.

This subscription price is equivalent to DKK 5.287 for the public offering in Denmark on the Nasdaq First North Growth Copenhagen based on the euro/DKK exchange rate on March 9, 2021.

Subscription period

Subscription for the New Shares will be open

from March 19 to March 31, 2021 inclusive on Euronext Growth Paris, and
from March 19 to March 26, 2021 inclusive on Nasdaq First North Growth Copenhagen.
Number of shares offered

13,052,968 New Shares, which may be increased to a maximum of 15,010,913 New Shares in the event of full exercise of the Extension Clause.

Gross proceeds of the operation

9,267,607 euros, which may be increased to 10,657,748 euros if the Extension Clause is exercised in full and to approximately 7,000,000 euros if the offer is limited to 75.5% of the amount of the planned capital increase (corresponding to subscription commitments).

Preferential subscription right

The subscription of the New Shares is reserved:

to the holders of existing shares registered in their securities account at the end of the accounting day of March 16, 2021 who will be granted preferential subscription rights (hereinafter "PSR") at the rate of 1 PSR per share held,
to the assignees of preferential subscription rights.
Holders of preferential subscription rights will be able to subscribe:

on an irreducible basis at the rate of 1 New Share at 0.71 euro per share for every 6 existing shares owned. 6 PSR will allow to subscribe for 1 New Share at a price of 0.71 euro per share. Subscriptions on an irreducible basis will be allocated in full to enable the shareholder to maintain his participation in the capital; and
the number of New Shares, on a free basis, they would like in addition to the number of New Shares they are entitled to in respect of the exercise of their irreducible rights.
No reducible subscription is planned within the framework of the Rights Issue.

Listing period for preferential subscription rights

The preferential subscription rights will be listed on Euronext Growth Paris and Nasdaq First North Growth Copenhagen under ISIN code FR0014001YS4.

on Euronext Growth Paris: from March 17 to March 29, 2021 inclusive;
on Nasdaq First North Growth Copenhagen: from March 17 to March 24, 2021 inclusive.
Theoretical value of the preferential subscription right

0.006 euro (based on the closing price of Onxeo shares on March 8, 2021, i.e., 0.75 euro). The subscription price of 0.71 euro per share represents a discount of 4.6% compared to the theoretical ex-right value of the share.

The offer will be open to the public in France and Denmark only.

Subscription commitments

Financière de la Montagne and Invus Public Equities LP, core shareholders of the Company, have committed to participate in the transaction for a maximum total amount of approximately €7.0 million, of which approximately €2.23 million on an irreducible basis.

The New Shares that may not be absorbed by irreducible subscriptions will be allocated in priority to shareholders having signed subscription commitments, Invus Public Equities LP and Financière de la Montagne, and then to requests from institutional investors.

These commitments to subscribe represent thus 75.5% of the total amount of the central offering of the Rights Issue.

These commitments will at least allow to reach the completion threshold (75%) of the Offering if the subscriptions on an irreducible basis do not allow it and may be called beyond that threshold as free subscriptions, in order to reach the initial size of the issue, if again the subscriptions on an irreducible basis do not allow it.

Impact of the issue on the shareholding structure

As an indication, the theoretical impact of the issue, in the event that the transaction is completed at 100% (excluding the Extension Clause) and in the event that the subscription commitments of Financière de la Montagne and Invus Public Equities LP were to affect in their entirety the distribution of the Company’s capital and voting rights (as at March 9, 2021) is as follows:

% capital ownership Before the issue After the issue
Financière de la Montagne 13.36% 16.08%
Invus Public Equities LP 10.72% 15.36%
Guarantee

The issue is not subject to a guarantee contract.

DILUTION

For information purposes, the impact of the issue on the capital ownership of a shareholder holding 1% of the Company’s share capital prior to the issue and who does not subscribe to the issue (calculations based on a number of 78,094,959 shares making up the Company’s share capital at December 31, 2020 after deduction of treasury shares) would be as follows:

Shareholder’s interest (%)
(in euros per share) Non-diluted basis Diluted basis (1)
Before issue of 13,052,968 New Shares 1.00 0.95
After issue of 9,789,726 New Shares(2) 0.89 0.85
After issue of 13,052,968 New Shares (3) 0.86 0.82
After issue of 15,010,913 New Shares (4) 0.84 0.80
(1) Taking into account the 4,335,740 options and warrants giving access to the share capital granted and outstanding as of the date of this securities note.

(2) Capital increase up to 75.5% of the initial number of new shares to be issued.

(3) Capital increase up to 100% of the initial number of new shares to be issued.

(4) Capital increase up to 115% of the initial number of new shares to be issued (full exercise of the Extension Clause).

INDICATIVE TIMETABLE OF THE OPERATION

March 9, 2021 AMF approval of the Prospectus.
March 10,2021 Notification of a certificate of approval by the AMF to the Danish Financial Supervisory Authority ("FSA") (Finanstilsynet).
Distribution of a press release describing the main features of the operation and the means by which the Prospectus will be made available to the public.

March 11, 2021 Publication by Euronext Paris and Nasdaq First North Growth Copenhagen of a notice of issue.
March 12, 2021 Start of the suspension period of the right to transfer the Company’s current shares between Euronext Growth Paris and Nasdaq First North Growth Copenhagen.
March 16, 2021 Accounting day at the end of which the holders of current shares registered for accounting purposes in their securities account will be attributed preferential subscription rights.
March 17, 2021 Detachment and start of trading of preferential subscription rights on Euronext Growth Paris and on Nasdaq First North Growth Copenhagen.
March 18, 2021 Record date
March 19, 2021 Regaining of the right to transfer the Company’s existing shares between Euronext Growth Paris and Nasdaq First North Growth Copenhagen.
Opening of the subscription period on Euronext Growth in Paris and on Nasdaq First North Growth in Copenhagen.

March 24, 2021 End of preferential subscription rights listing on Nasdaq First North Growth Copenhagen.
March 26, 2021 Closing of the subscription period on Nasdaq First North Growth Copenhagen.
March 29, 2021 End of preferential subscription rights listing on Euronext Growth.
March 31, 2021 Closing of the subscription period on Euronext Growth Paris.
April 12, 2021 Possible exercise of the Extension Clause.
Distribution of a press release by the Company announcing the result of the subscriptions.

Distribution by Euronext Paris of the notice of admission of the New Shares indicating the final amount of the capital increase and indicating the allocation scale.

April 16, 2021 Issuance of New Shares – Settlement and Delivery.
April 19, 2021 Admission of the New Shares to trading on Euronext Growth Paris and Nasdaq First North Growth Copenhagen.
INFORMATION FOR DANISH SHAREHOLDERS

The subscription price of the New Shares is denominated in euros.

Any shareholder wishing to subscribe for the New Shares on the Nasdaq First North Growth Copenhagen must pay the subscription price of the New Shares (fixed in euros) in Danish kroner, i.e. DKK 5.287 (based on the exchange rate on March 9, 2021). The Company has entered into a hedging agreement with Nordea Denmark, a subsidiary of Nordea Bank Abp, Finland, to hedge against any potential change in the euro/DKK exchange rate.

The Company will not bear any costs related to the subscription of the New Shares other than those related to the currency hedging contract entered into with Nordea.

AVAILABILITY OF THE PROSPECTUS

The Prospectus, having received the approval n°21-063 dated March 9, 2021 from the Autorité des marchés financiers ("AMF"), consists of (i) the Universal Registration Document of Onxeo filed with the AMF on April 27, 2020 under number D.20-0362 (the "Universal Registration Document"), (ii) the Amendment to the Universal Registration Document, filed with the AMF on March 9, 2021 under number D.20-0362-A01, (iii) a Securities Note and (iv) a summary of the Prospectus (included in the Securities note).

Copies of the Prospectus are available free of charge at the registered office of Onxeo, 49, boulevard du Général Martial Valin – 75015 Paris. The Prospectus may also be consulted on the websites of the AMF (www.amf-france.org) and Onxeo (www.onxeo.com) and from the Lead Manager and Bookrunner.

In connection with the opening of the public offering in Denmark, an unofficial translation into English of all the documents constituting the prospectus has also been prepared by the Company. In the event of any discrepancy between the French prospectus and the English translation, the French version will prevail. These documents are also available free of charge at Onxeo’s registered office at 49, boulevard du Général Martial Valin – 75015 Paris and on Onxeo’s website (www.onxeo.com).

Risk Factors

Investors are invited to carefully consider the risk factors detailed in section 3 of the Universal Registration Document, section 2 of the Amendment to the Universal Registration Document and section 2 of the Securities Note. The occurrence of all or part of these risks may have an adverse effect on the Group’s business, financial position, results or ability to achieve its objectives.

Curaleaf to Enter European Cannabis Market with Acquisition of EMMAC Life Sciences Limited – Europe’s Leading Independent Cannabis Company

On March 10, 2021 EMMAC Life Sciences Group, Europe’s largest independent cannabis company, reported that it is has signed a definitive agreement to be acquired by Curaleaf Holdings, Inc. (CSE: CURA) (OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading U.S. provider of consumer products in cannabis, for a base consideration of approximately US$285 million to be paid in 85%/15% Curalfeaf shares and cash (Press release, EMMAC Life Sciences, MAR 10, 2021, View Source [SID1234576609]). Contingent consideration of up to $57 million will be paid in Curaleaf shares and cash in the same ratio based upon the successful achievement of performance milestones. The proposed transaction provides Curaleaf with a developed platform for entry into the European cannabis market.

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As Europe’s largest vertically integrated independent cannabis company, EMMAC’s platform brings cultivation, EU-GMP processing, distribution, and R&D operations across several key European medical cannabis markets, including the United Kingdom, Germany, Italy, Spain and Portugal. EMMAC also has an operational presence and partnerships in European Union countries that are enacting new medical cannabis access programs. EMMAC’s Portugal based cultivation facility is an industry leader in cannabis flower production cost.

Boris Jordan, Curaleaf Executive Chairman, stated, "Curaleaf’s acquisition of EMMAC, announced today, provides an advanced base to reach scale within the nascent European cannabis market and transform Curaleaf into a truly international cannabis consumer packaged goods company. The consumer and political liberalization trends around cannabis that are sweeping the U.S. are also increasingly taking hold in Europe. Curaleaf will seek to leverage our branded cannabis consumer packaged goods strategy across Europe, a market which provides for cross-border cannabis distribution. The European cannabis market has the potential to exceed the U.S. cannabis market over the long-term and will help fuel our growth for years to come."

Antonio Costanzo, Chief Executive Officer of EMMAC, said, "Curaleaf’s acquisition of EMMAC is not only a significant milestone for EMMAC, but for the European cannabis market as a whole. As part of Curaleaf, a well-capitalized leader of the U.S. cannabis market, EMMAC is poised to exploit the rapid pace of growth of the European market, driven by regulatory change and the increasing demand for access to premium quality cannabis products. The combination of Curaleaf and EMMAC creates a global platform to address these large new opportunities across Europe. With EMMAC’s science-led approach, wealth of local market experience, as well as our network of supply and distribution partnerships throughout Europe, we are now uniquely positioned to reinforce our place as one of Europe’s leaders in the production and supply of medical cannabis, wellness CBD, hemp and other derivative products."

Transaction Terms & Approvals

Curaleaf will acquire EMMAC for base consideration of £0.50 per share, comprised of approximately GBP£35 million in cash, approximately 16.774 million subordinate voting shares of Curaleaf (based on the exchange ratio of Curaleaf share for each EMMAC share agreed by the parties). At yesterday’s Curaleaf closing share price on the CSE, the base consideration is valued at $285 million2. An additional US$57 million3 consideration will be paid subject to performance-based earn-outs. Post-transaction, the former shareholders of EMMAC will have approximately 3% pro forma ownership of Curaleaf on a fully-diluted basis, before factoring in the performance-based earn-outs. The Curaleaf share consideration will be subject to a statutory four-month hold period as well as a lock-up agreement with each recipient restricting trading of the share received, with release of 5% from such restrictions at the end of each calendar quarter following the closing. The proposed transaction is expected to close early in the second quarter of 2021, subject to customary closing conditions and regulatory approval. The transaction has been unanimously approved by the boards of directors of both EMMAC and Curaleaf, with Mr. Boris Jordan abstaining from the voting.

Transaction Advisors

Stikeman Elliott LLP and Memery Crystal LLP acted as legal advisors to Curaleaf. Eight Capital acted as financial advisors and provided a fairness opinion to the Special Committee. Canaccord Genuity Group acted as financial advisor and provided a fairness opinion to EMMAC, and Norton Rose Fulbright acted as legal advisor to EMMAC. EMMAC’s European legal team was led by Hill Dickinson LLP in the United Kingdom.

Immunocore Announces Upcoming Presentations at the American Association for Cancer Research (AACR) 2021 Annual Meeting

On March 10, 2021 — Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, reported that four abstracts highlighting the Company’s lead program, tebentafusp, were accepted at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, which will be held virtually from April 10-15, 2021 (Press release, Immunocore, MAR 10, 2021, View Source [SID1234576524]). Two abstracts will be presented as oral presentations including, in the plenary session, Phase 3 data comparing tebentafusp (IMCgp100) with investigator’s choice in first line metastatic uveal melanoma (mUM). A second oral presentation will feature data on the kinetics of radiographic response for tebentafusp in previously treated mUM patients. Two abstracts will be poster presentations.

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PLENARY AND ORAL PRESENTATIONS

Title: Phase 3 randomized trial comparing tebentafusp with investigator’s choice in first line metastatic uveal melanoma

Date and Time: Plenary session presentation (CT002), Saturday April 10th at 11:30am – 1:30pm ET
Presenter: Jessica C. Hassel (PI), University Hospital Heidelberg, Heidelberg, Germany
Abstract #: 5342
Session Title: Phase III Clinical Trials
Title: Kinetics of radiographic response for tebentafusp (tebe) in previously treated metastatic uveal melanoma (mUM) patients (pts) achieving prolonged survival

Date and Time: Oral presentation (CT038), Monday April 12th at 1:30pm – 3:15pm ET
Presenter: Marcus O. Butler (PI), Princess Margaret Cancer Centre, Toronto, ON, Canada
Abstract #: 5338
Session Title: Disease-Oriented Innovative Clinical Research and Trials
POSTER PRESENTATIONS

Title: Uveal melanoma study patients with low CD163:CD3 ratio in tumor biopsy and low serum IL-6 showed enhanced tumor shrinkage (TS) and overall survival (OS) on tebentafusp

Poster #: 1673
Presenter: Jessica Hassel (PI)
Title: Tebentafusp induces transient systemic inflammation and modifies the micro-environment to sensitize uveal melanoma tumors to cytotoxic CD8 cells

Poster #: 517
Presenter: Marcus O. Butler (PI)
Presentations and posters will be available for registered attendees for on-demand viewing on the AACR (Free AACR Whitepaper) website beginning on April 10th 2021.