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BioCure Technology Inc. Announces Closing of Financing

On July 14, 2021 BioCure Technology Inc. (CSE: CURE) ("BioCure" or the "Company") reported that it has successfully closed a non-brokered private placement (the "Private Placement") consisting of 6,706,525 Units at a price of $0.16 cents per Unit for gross proceeds of $1,073,044.00 (Press release, Biocure Technology, JUL 14, 2021, View Source [SID1234628743]).

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Each Unit is comprised of one common share (the "Shares") and one share purchase warrant (the "Warrants") of the Company, where each whole Warrant entitles the holder to purchase an additional share for a period of two years from closing, at a price of $0.21 per Warrant share (the "Warrant Shares").

The Company has also agreed to pay a finder’s fee of 8% in cash ("Finders Cash") and 8% in warrants ("Finder Warrants") for the proceeds raised by the finders ("Finders") in connection with the private placement. The Finder Warrants are on the same terms as the Purchaser Warrants. All finder fees are subject to CSE ("Exchange") approval.

The net proceeds from the non-brokered private placement are intended to be used for general working capital, research and development.

Allarity Therapeutics Issues Share Units as Payment-In-Kind for Services Rendered During Rights Issue in Q2 2021

On July 14, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported a payment-in-kind and a debt conversion structured as a directed issue of 24,112,523 new share Units to the guarantors and to the global coordinator and bookrunner, Aalto Capital AB, of the rights issue completed on 11 June 2021 (the "Rights Issue") (Press release, Allarity Therapeutics, JUL 14, 2021, View Source [SID1234584884]).

The fee structure and payment-in-kind to be paid in Units to guarantors was described in the prospectus published on 19 May 2021 (the "Prospectus"): each Unit in the directed issue consists of one (1) new share of nominal DKK 0.05 with one (1) warrant attached which grants the right to subscribe one (1) share of nominal DKK 0.05 share in the Company at an exercise price of SEK 1.7. New shares are subscribed against by either receiving shares as payment-in-kind or by debt conversion. The warrants are subscribed without payment. Thereby, the Units in the directed issue are similar to the TO 3 warrants, issued as a part of the Rights Issue, and they will be issued under the same short-name (ALLR TO 3).

The Company carries out the directed issue of the 24,112,523 Units based on a Board resolution from 13 July 2021, pursuant to the authorization granted by the annual general meeting on 15 April 2021.

Of the total 24,112,523 Units, 14,349,536 Units are issued to the guarantors of the Rights Issue at a price of SEK 0.85 per Unit as described in the Prospectus. The guarantors receiving the largest numbers of Units are John Faalstrom (3,529,411 Units) and Crafoord Asset Management AB (1,411,764 Units). Moreover, 9,762,987 Units are issued to Aalto Capital AB as a debt conversion of approximately SEK 8.3 million, at a price of SEK 0.85 per Unit, for various services rendered to the Company before and during the Rights Issue.

The new shares, with a nominal per share value of DKK 0.05, hold no special rights. Following the directed issue, the share capital of the Company is a total of DKK 19,339,299.70 divided into 386,785,994 shares of nominal value DKK 0.05.

In the event that all warrants in the directed issue are fully exercised for subscription of new shares in the Company, the number of shares in the Company will increase with an additional maximum of 24,112,523 shares, from 386,785,994 shares to 410,898,517 shares, and the share capital will increase with an additional maximum DKK 1,205,626 from DKK 19,339,299.70 to DKK 20,544,925.85. These projections does not take into account possible exercise of other issued warrants in series TO 2 and TO 3.

PharmaCyte Biotech Announces Update on Study Progress and Uplist to Nasdaq

On July 14, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCBD), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that the production and shipping of test materials and study plan designs for the biocompatibility studies requested by the U.S. Food and Drug Administration (FDA) have been completed (Press release, PharmaCyte Biotech, JUL 14, 2021, View Source [SID1234584883]).

The "CypCaps" product represents a refinement of the original encapsulated cells that were successfully tested in previous clinical trials. In order to show comparability, the FDA requested that standard biocompatibility studies be performed by a Contract Research Organization (CRO) in accordance with regulatory requirements. Study plans have been finalized and the Company’s most time-consuming study has already commenced and is ongoing. These studies required the production of additional capsule material for testing, and this effort has been completed by Austrianova. Some of the material also had to be prepared and treated in accordance with the requirements of the tests. This work has also been completed and the materials, both treated and non-treated, have been shipped to and received by, the CRO.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "The commencement of the most rate-limiting study represents yet another major step for complying with the FDA’s requirements. As our work continues to advance to produce the required data to satisfy the FDA and move toward an open IND, our expectation is to complete the FDA’s list of requirements in the Fourth Quarter of this year.

"Additionally, as we continue our work to achieve an open IND, we have also continued our plan to make ourselves more attractive to the investment community and uplist to Nasdaq. We believe the reverse stock split, which was recently enacted, will assist the Company in pursuing additional financing activities and other strategic transactions to support the development of our product candidates. We believe this is a necessary step before the Company’s common stock can be listed on a national stock exchange like Nasdaq, which is our expectation. Nasdaq is requiring the Company to trade above $4.00 for 10 trading days before we can uplist."

AstraZeneca receives final regulatory clearance for the proposed acquisition of Alexion from the UK’s Competition and Markets Authority

On July 14, 2021 AstraZeneca reported The UK Competition and Markets Authority has cleared proposed acquisition of Alexion Pharmaceuticals, Inc. (Alexion) (Press release, AstraZeneca, JUL 14, 2021, View Source [SID1234584868]). As a result, the acquisition is expected to close on 21 July 2021.

Following closing, the new AstraZeneca shares issued to Alexion shareholders will be admitted to listing on the premium listing segment of the official list of the UK Financial Conduct Authority (FCA) and to the secondary listing on Nasdaq Stockholm. In addition, the new AstraZeneca American Depositary Shares (ADSs) will be admitted on the Nasdaq Stock Market. Trading on the London Stock Exchange’s main market for listed securities, Nasdaq Stockholm and the Nasdaq Stock Market, is expected to commence on 22 July 2021. In addition, the Alexion shares will be de‐listed from the Nasdaq Stock Market. They will be deregistered under the Exchange Act as soon as practicable following completion of the acquisition.

Marc Dunoyer, Executive Director and Chief Financial Officer, said: "We are very pleased to have secured this critical final clearance from the UK Competition and Markets Authority for the acquisition of Alexion. We look forward to the imminent closing of the transaction so that we may pursue our shared ambition to bring more innovative medicines to patients worldwide and begin AstraZeneca’s next chapter of growth."

The proposed acquisition, first announced in December 2020, will enhance the Company’s scientific presence in immunology by adding Alexion’s innovative complement-technology platforms and robust pipeline. Rare diseases represent a high-growth opportunity with rapid innovation and significant unmet medical needs. Shareholders of both companies overwhelmingly voted in support of the transaction on 11 May 2021.

Subject to completing the acquisition, a group focusing on rare diseases will be created. This group will be named ‘Alexion, AstraZeneca Rare Disease’, and will be headquartered in Boston, US.

Financial considerations
AstraZeneca anticipates providing updated 2021 financial guidance for the new, combined entity in due course. Consolidation of Alexion will start from the closing of the transaction and the first quarter of consolidated financial reporting is expected to be the third quarter of 2021 due for announcement on Wednesday 10 November 2021.

Rare diseases
Over 7,000 rare diseases are known today, and only approximately 5% have treatments approved by the US Food and Drug Administration.1 Demand in medicines for rare diseases is forecasted to grow by a low double-digit percentage in the future.2

Important additional information
In connection with AstraZeneca’s proposed acquisition of Alexion (the Acquisition), AstraZeneca filed a registration statement on Form F-4 with the SEC on 12 April 2021 (the Registration Statement), which has been declared effective by the United States Securities and Exchange Commission, and which includes a document that serves as a prospectus of AstraZeneca and a proxy statement of Alexion (the proxy statement/prospectus), Alexion filed a proxy statement with the SEC (the proxy statement) on 12 April 2021, and each party will file other documents regarding the Acquisition with the SEC. Investors and security holders of Alexion are urged to carefully read the entire Registration Statement and proxy statement/prospectus or proxy statement and other relevant documents filed with the SEC when they become available, because they will contain important information. Investors and security holders may obtain the Registration Statement and the proxy statement/prospectus or the proxy statement free of charge from the SEC’s website or from AstraZeneca or Alexion as described in the paragraphs below.

The documents filed by AstraZeneca with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov. These documents may also be obtained free of charge on AstraZeneca’s website at View Source under the tab "Investors". The documents filed by Alexion with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov. These documents may also be obtained free of charge on Alexion’s internet website at View Source under the tab, "Investors" and under the heading "SEC Filings" or by contacting Alexion’s Investor Relations Department at [email protected].

Nkarta Establishes New Combined NK Cell Therapy Manufacturing Facility / Company Headquarters

On July 14, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported that it has signed a lease agreement for a facility to support research and development and future commercial manufacturing of Nkarta’s cell therapy pipeline (Press release, Nkarta, JUL 14, 2021, View Source [SID1234584866]). The new facility will also serve as the company’s headquarters with office space and research facilities. The manufacturing center will be custom designed to complement Nkarta’s state-of-the-art technology platform and optimize the production of its multiple off-the-shelf NK cell therapy investigational products. Nkarta plans to produce materials for potential pivotal clinical trials and commercial launch at the new center.

"Our goal is to ensure that cost-effective, commercial-scale production of cell therapies can be made available widely and rapidly to the cancer patients who need them, and we expect this new facility will enable us to do just that," said Paul J. Hastings, President and CEO of Nkarta. "As we advance our NKX101 and NKX019 clinical programs and enhance our proprietary platform with exciting new capabilities like CRISPR Cas9 genome engineering, we believe our expanded footprint will drive continued operational excellence and accelerate the development of transformative NK cell therapies for a broad range of cancers."

Earlier this year, Nkarta completed the construction and qualification of a 2,700 square foot cGMP facility at its primary location in South San Francisco, California. This current clinical manufacturing facility was designed to integrate with Nkarta’s internal process development expertise and meet the production needs of Nkarta’s research activities and early stage clinical trials. Nkarta is currently manufacturing clinical supply for its planned Phase 1 study of NKX019, expected to start in the second half of 2021, and plans to transfer the production of NKX101 and other proprietary platform materials to the clinical manufacturing facility in the future.

The newly leased facility in South San Francisco will be built-out as a multi-product facility and is expected to be operational by the end of 2023. At full capacity, the manufacturing center is expected to have the flexibility to produce commercial supply of multiple cell therapy products. Nkarta will also consolidate administrative offices and research and development laboratories at the new site.

About NKX101
NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. A multi-center Phase 1 clinical trial of NKX101 in patients with relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS) is currently enrolling. Additional information about the clinical trial is available on ClinicalTrials.gov, identifier NCT04623944.

About NKX019
NKX019 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with a CD19-directed chimeric antigen receptor (CAR) and a proprietary, membrane-bound form of interleukin 15 (IL-15). CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. Via its CAR, NKX019 targets and binds to CD19 and eliminates CD19-expressing cells via a robust immune response in preclinical studies. Preclinical models also demonstrate enhanced proliferation, persistence and activity of NK cells with the membrane-bound IL-15, an important cytokine for NK cell survival. Initiation of a Phase 1 clinical trial of NKX019 in patients with relapsed/refractory B cell malignancies in multiple centers in the United States and Australia is planned for the second half of 2021.

About Nkarta’s Platform and Natural Starting Materials
Nkarta’s engineering platform utilizes healthy adult donors as the source for NK cells. By enlisting this natural source of NK cells, Nkarta starts with bona fide NK cells endowed with inherent tumor-recognizing ability and potent cytotoxic function. Healthy donor-derived NK cells are also available in abundance, providing a large quantity of cells with which to begin the efficient two-week manufacturing process. Finally, healthy donor-derived adult cells consist of a diverse repertoire of NK cells, providing Nkarta with the potential to capitalize on the inherent diversity of the innate immune system in selecting donors or NK cell populations with optimal characteristics.

About Nkarta’s NK Cell Technologies
Nkarta has pioneered a novel discovery and development platform for the engineering and efficient production of allogeneic, off-the-shelf natural killer (NK) cell therapy candidates. The approach harnesses the innate ability of NK cells to recognize and kill tumor cells. To enhance the inherent biological activity of NK cells, Nkarta genetically engineers the cells with a targeting receptor designed to recognize and bind to specific proteins on the surface of cancerous cells. This receptor is fused to co-stimulatory and signaling domains to amplify cell signaling and NK cell cytotoxicity. Upon binding the target, NK cells become activated and release cytokines that enhance the immune response and cytotoxic granules that lead to killing of the target cell. All of Nkarta’s NK current cell therapy candidates are also engineered with a membrane-bound IL15, a proprietary version of a cytokine known for activating NK cell growth, to enhance the persistence and activity of the NK cells.

Nkarta’s manufacturing process generates an abundant supply of NK cells that, at commercial scale, is expected to be significantly lower in cost than other current allogeneic and autologous cell therapies. Key to this efficiency is the rapid expansion of donor-derived NK cells using a proprietary NKSTIM cell line, leading to the production of hundreds of individual doses from a single manufacturing run. The platform also features the ability to freeze and store CAR NK cells for an extended period of time and is designed to enable immediate, off-the-shelf administration to patients at the point of care.