On June 29, 2021, Intellia Therapeutics, Inc. (the "Company" or "Intellia") reported that it entered into an Underwriting Agreement (the "Underwriting Agreement") with Goldman Sachs & Co LLC, Jefferies LLC, SVB Leerink LLC, and Barclays Capital Inc. as representatives of the several underwriters listed on Schedule A thereto (the "Underwriters"), related to a public offering (the "Offering") of 4,137,931 shares of common stock of the Company, par value $0.0001 per share (the "Common Stock") at a price to the public of $145.00 per share (Filing, 8-K, Intellia Therapeutics, JUN 29, 2021, View Source [SID1234584582]). In addition, the Company granted the Underwriters an option exercisable for 30 days from the date of the Underwriting Agreement to purchase, at the public offering price less any underwriting discounts and commissions, up to an additional 620,689 shares, which option was exercised in full on June 30, 2021. The Company estimates that the net proceeds from the offering will be approximately $648.1 million, including the additional shares, after deducting the underwriting discount and its estimated offering expenses. The offering is expected to close on July 2, 2021, subject to customary closing conditions.

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The Company made certain customary representations, warranties and covenants concerning the Company and the registration statement in the Underwriting Agreement and also agreed to indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended (the "Securities Act"). The Offering was made pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-251022), including the prospectus dated November 30, 2020, as supplemented by a prospectus supplement dated June 29, 2021. This Current Report on Form 8-K does not constitute an offer to sell or the solicitation of an offer to buy any of the shares of Common Stock.

The foregoing description of certain terms of the Underwriting Agreement and the transactions contemplated thereby does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Underwriting Agreement, which is attached as Exhibit 1.1 hereto and is incorporated by reference herein. A copy of the opinion of Goodwin Procter LLP, relating to the legality of the ordinary shares, is filed as Exhibit 5.1 hereto and is incorporated by reference herein.

On June 29, 2021 Curaleaf International (formerly EMMAC Life Sciences Group), Europe’s largest vertically integrated cannabis company, reported that its wholly owned subsidiary, Adven GmbH ("Adven"), has announced a strategic partnership with Zambon GmbH, the German subsidiary of Zambon Spa, an Italian multinational pharmaceutical company, leading in Parkinson’s Diseases, Severe Respiratory Diseases and Pain (Press release, EMMAC Life Sciences, JUN 29, 2021, View Source [SID1234584505]). The aim of the agreement is to make medical cannabis treatments available to patients.The first treatment will be launched in Germany in Summer 2021.

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"We are delighted to be announcing this partnership with Zambon today, and to be working with a leading pharmaceutical company to create the first European pharmaceutical and medical cannabis partnership; we believe it is testament to our continued commitment to research-led product excellence at Curaleaf International," says Curaleaf International CEO, Antonio Costanzo. "We are looking forward to strengthening our collaboration and the creation of more such partnerships, where relevant pharmaceutical and medical cannabis expertise and excellence can be combined to advance the industry’s understanding of medical cannabis for the rapidly growing European patient community."

"Supporting therapies, like medical cannabis, are a meaningful addition to Zambon’s European portfolio. Our expertise in neurology and Curaleaf International’s knowledge of the pharmaceutical active processes of cannabinoids provide ideal conditions to bring innovative treatment to patients," says Marco Castino, Head of Region Europe in Zambon.

The market for medical cannabis in Germany

Since 2017, cannabis has been approved for therapeutic use in Germany and may be prescribed by doctors for serious illnesses. Germany is Europe’s largest market for medical cannabis. It is expected to be worth USD 2.1 billion[1] by 2025.

"We are constantly seeking ways to enhance the life of chronically neurologically ill patients with our products. Offering modern therapy approaches, such as co-medication, especially in view of the progression of these clinical pictures, is part of our vision to improve patients‘ lives" says Dirk Greshake, Zambon GmbH General Manager.

"As strategic partners, we are combining our experience and resources for the benefit of the patient. Together we want to advance the development of high-quality medicinal cannabis and have made it our mission to improve the quality of life of neurological patients who still have symptoms despite conventional therapy. With Zambon‘s many years of experience as a research company in the field of neurology and Adven GmbH, as part of Curleaf International, Europe’s largest vertically integrated medical cannabis company with its comprehensive expertise in the development and production of medicinal cannabis, we believe we have a unique partnership in place to address these patient requirements," explains Julian Vaterrodt, CEO of Adven GmbH.

On June 29, 2021 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, reported that it has raised £10.0 million (before expenses) by way of a placing to investors in the UK ("Placing") of 35,087,720 new ordinary shares of 0.1p each ("Placing Shares") at an issue price of £0.285 per Placing Share ("Issue Price"). The Placing brings new UK institutions into the Company’s shareholder base. Turner Pope Investments (TPI) Limited ("Turner Pope") acted as sole bookrunner for the Placing. Turner Pope participated in the Placing.

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The Issue Price of the Placing Shares represents a discount of approximately 12.3% to the closing middle market price of £0.325 per existing ordinary share on 28 June 2021, being the last business day before this announcement. The Placing Shares represent approximately 35.6% of the issued share capital of the Company as enlarged by the Placing.

The allotment of the Placing Shares is being made pursuant to existing authorities to allot shares and other relevant securities and to disapply pre-emption rights under section 551 of the Companies Act 2006, which the Directors were given at the Company’s General Meeting held on 2 March 2020.

Background to the Placing

On 17 June 2021, the Company announced a series of updates to its R&D programmes including:

·data that demonstrate the Company has been able to encapsulate an exemplar monoclonal antibody ("mAb") using its Q-Sphera technology while preserving its functional integrity and antigen binding;
·delivery of proof of concept Q-Sphera formulations of MTX214 and MTX216 for the Company’s collaboration partner to initiate in vivo IND-enabling studies;
·in vivo data to support a three month dosing interval for MTD211, the Company’s formulation of long-acting brexpiprazole;
·start up activities for a Phase II study of MTX110 in Diffuse Intrinsic Pontine Glioma ("DIPG") following a positive pre-IND meeting with the FDA; and
·planning for a Phase I pilot study of MTX110 in Glioblastoma Multiforme ("GBM") following encouraging preclinical data which demonstrate the potency of MTX110 in multiple patient-derived GBM cell lines.

Use of Proceeds

The proceeds of the Placing, net of fees and expenses, are expected to be approximately £9.0 million ("Net Proceeds"). We expect the Net Proceeds will be used to:

·develop, to proof of concept stage, additional mAb formulations using the Company’s Q-Sphera technology following the success with the exemplar mAb disclosed as part of the Company’s R&D update on 17 June 2021;
·add new small molecule Q-Sphera programmes to the Company’s internal pipeline;
·initiate a Phase II clinical study of MTX110 in DIPG;
·initiate a pilot Phase I clinical study of MTX110 in GBM; and
·general corporate purposes.

Taking into account available cash resources and the expected Net Proceeds, the Company expects to have sufficient cash resources to fund operations into the first quarter of 2023.

Further Information on the Placing

The Company and Turner Pope entered into a placing agreement ("Placing Agreement"), pursuant to which Turner Pope agreed to use its reasonable endeavours to procure placees pursuant to the Placing. The Placing is not underwritten. Turner Pope has received binding commitments from placees to acquire the Placing Shares at the Issue Price.

The Placing Agreement contains certain warranties and indemnities by the Company in favour of Turner Pope. It also contains provisions entitling Turner Pope to terminate the Placing Agreement prior to Admission, as defined below, if, among other things, a breach of any of the warranties occurs or on the occurrence of an event fundamentally and adversely affecting the position of the Company.

The Placing is conditional upon, inter alia:

(a)the Placing Agreement becoming unconditional in all respects (save for Admission occurring) and not having been terminated in accordance with its terms; and
(b)Admission becoming effective by no later than 8.00 a.m. on 6 July 2021 (or such later time and/or date as the Company and Turner Pope may agree (being not later than 4.30 p.m. on 3 August 2021).

Application for Admission to trading on AIM

Subject to all conditions being met, application will be made for the 35,087,720 Placing Shares to be admitted to trading on AIM ("Admission"). It is expected that settlement of the Placing Shares and Admission will take place at 8.00 a.m. on or about 6 July 2021 and that dealings in the Placing Shares will commence at that time.

When issued, the Placing Shares will be fully paid and will rank pari passu in all respects with the existing ordinary shares.

Total Voting Rights

Upon Admission, the Company’s issued share capital will comprise 98,468,387 ordinary shares of 0.1p each with voting rights. The Company does not hold any shares in treasury. Upon Admission this figure of 98,468,387 may be used by shareholders in the Company as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change in their interest in, the share capital of the Company under the FCA’s Disclosure and Transparency Rules.

Commenting, Stephen Stamp, Midatech CEO and CFO, said: "It has been a busy 13 months since we announced our Strategic Review and restructuring. On 17 June 2021 we announced progress in our R&D pipeline across multiple programmes and breakthrough data on the successful encapsulation of a large molecule protein with Q-Sphera – a world’s first. Today’s announcement of the Placing gives us the runway to initiate Phase II and Phase I clinical studies of MTX110 in DIPG and GBM, respectively. Our focus now turns to lining up partners for these programmes."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

The person responsible for arranging the release of this announcement on behalf of the Company is Stephen Stamp, Chief Executive Officer and Chief Financial Officer

On June 29, 2021 eTheRNA immunotherapies NV (‘eTheRNA’), a clinical-stage company developing mRNA-based immunotherapies with in-house GMP certified production and process development capabilities, and Quantoom Biosciences S.A. ("Quantoom"), a biotech company aiming to improve access to essential medicines through innovative bioproduction methods, reported that they are to collaborate on the development of a revolutionary RNA production system (RPS) for both research and GMP-grade material (Press release, eTheRNA, JUN 29, 2021, View Source [SID1234584493]).

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Quantoom and eTheRNA will work together to build an advanced, small footprint technology platform for the production of affordable RNA-based therapies, that can be used either within existing facilities or rapidly deployed to areas of urgent need. Unlike large and costly existing RNA production plants, the RPS will manufacture RNA small modular units, which can be shipped easily across multiple geographic regions. The RPS is intended to be scaled seamlessly from small scale preclinical batches to mass production of GMP-grade RNA. The only requirement will be for the RPS to be located inside a suitable clean room with an uninterrupted utility supply.

Under the terms of the agreement, eTheRNA will transfer manufacturing technology to Quantoom with all materials and data necessary for the development of the novel RPS. Following completion of the RPS, Quantoom will be responsible for commercialization of the system on a worldwide basis, with sales-related royalties payable to eTheRNA. International sales and distribution are expected to commence in 2023 following RPS production in Belgium.

Bernard Sagaert, SVP Manufacturing and COO of eTheRNA, commented: "This cooperation aligns with our goals for RNA production; namely cost reduction, process scalability from small to large scale, portability and process automation. Currently, the global supply of RNA is hampered by the lack of dedicated production facilities and by the cost of constructing new plants. The RPS will revolutionize the way RNA is produced and distributed globally and we are excited to be able to work with a leading developer and manufacturer like Quantoom to bring this vision to the market."

José Castillo, CEO of Quantoom Biosciences, commented: "We are delighted to enter into this collaboration agreement with eTheRNA, which has extensive experience in the field of RNA and like Quantoom, has a mission to change the RNA world. Through our combined knowhow, I am confident that Quantoom will be able to develop an open, integrated RNA platform that will enable manufacture of RNA-based vaccines and therapeutics at scale, resulting in affordable development and production of RNA-based drugs. "

On June 29, 2021 Ixaka Ltd and SomaLogic reported a research collaboration to support the development of aptamer-based bispecific therapeutics (Press release, Ixaka, JUN 29, 2021, View Source [SID1234584492]).

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The collaboration will evaluate the safety and efficacy of antigen-specific SOMAmer reagents (modified aptamers that bind tightly and specifically to protein targets) previously identified and screened by SomaLogic as potential candidates for combination with Ixaka’s anti-CD3 aptamers.

Ixaka is currently developing in vivo CAR-T therapies using its in vivo gene delivery technology, which facilitates in vivo targeting and transduction of patient T cells. The universal in vivo gene modification approach relies on proprietary anti-CD3 aptamers selected by Ixaka as targeting agents, which have been applied to engineer aptamer-based BiTEs (Bi-specific T-cell engagers).

SomaLogic’s antigen-specific SOMAmer reagents will now be evaluated with the intention of improving both the safety and efficacy of antibody-based bispecifics. This follows a recent in vitro proof-of-concept study that successfully highlighted the potential of Ixaka’s cancer specific antigenxCD3 bispecific aptamers as new anticancer agents that can recruit cytotoxic T cells and induce killing of tumor cells.

Cecile Bauche, Vice President and Chief Scientific Officer at Ixaka, commented: "We have made great progress with our anti-CD3 aptamer candidate, with recent positive data demonstrating in vitro proof of concept when combined with a cancer-specific antigenic aptamer. SOMAmer molecules are a promising new class of drug entities with the potential to accelerate development of our aptamer-based BiTEs as anti-cancer agents and help us in our mission to offer new and effective treatments for cancer."

Renaud Vaillant, Vice President, Business Development at Ixaka, commented: "We have been working with aptamers as potential immunotherapies since the inception of the company. We first engaged in discussion with SomaLogic 4 years ago, when the project was just an idea as part of a presentation. I am proud and excited to finally start this collaboration, which is a result of the tremendous work achieved by our team."

In the collaboration, SomaLogic will provide SOMAmers for screening and subsequent evaluation of in vitro cytotoxic properties. Ixaka will lead the experiments to identify and evaluate SOMAmer candidates with high affinity and specificity. Further work will determine functional in vitro properties of bispecific aptamers in human cell cultures and evaluate in vivo anticancer efficacy in murine models.

Nebojsa Janjic, Chief Science Officer of SomaLogic, commented: "The ability of SOMAmer reagents to bind with high specificity and affinity to any target protein makes them ideal for the development of novel therapies for oncology. We hope to expand this collaboration with Ixaka in the future to support new treatments for other therapeutic areas."

SomaLogic’s anti-tumoral SOMAmers demonstrate potential utility as the chemical addition of ‘protein-like’ side chains to the nucleic acid bases that comprise a SOMAmer can be used to develop molecules with high specificity and affinity for any targeted protein, making SOMAmer candidates attractive for novel therapeutic development.

The first application of Ixaka’s TNP technology is the generation of CAR T-cell therapies for haematological malignancies. However, modification of the components offers the potential to target a broad range of therapeutic cells for the treatment of many serious diseases, including cancers, genetic disorders, neurological and ocular diseases.