On August 14, 2020 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 the U.S. Securities and Exchange Commission ("SEC") has declared effective the Company’s registration statement on Form F-1 (the "Registration Statement") relating to the permitted resale of up to 12,695,445 ordinary shares, nominal value 0.1p each, in the Company ("Ordinary Shares") represented by 2,539,091 American Depositary Shares (the "ADSs") held by certain stockholders of the Company named in the registration statement that are issuable upon the exercise of previously issued warrants as follows (Press release, Midatech Pharma, AUG 14, 2020, View Source [SID1234563638]):

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·3,150,000 Ordinary Shares represented by 630,000 ADSs issuable upon exercise of warrants at $6.25 per ADS. These warrants were issued pursuant to a US Registered Direct Offering in October 2019;

·9,545,455 Ordinary Shares represented by 1,818,182 ADSs issuable upon exercise of warrants at $2.05 per ADS. These warrants were issued pursuant to a US Registered Direct Offering in May 2020; and

·454,549 Ordinary Shares represented by 90,909 ADSs issuable upon exercise of warrants at $2.0625 per ADS. These warrants were also issued pursuant to a US Registered Direct Offering in May 2020.

In addition, in May 2020, warrants were issued to certain UK investors in respect 3,213,957 Ordinary Shares exercisable at £0.34 per share. These warrants became exercisable upon the effectiveness of the Registration Statement.

The Registration Statement, while effective, allows the stockholders named in the Registration Statement to publicly resell the ADSs or Ordinary Shares. The Company will not receive any proceeds from the sale of the ADSs or Ordinary Shares by the stockholders. Upon the cash exercise of the warrants, the Company will receive the exercise price of the warrants.

The Registration Statement may be accessed through the SEC’s website at www.sec.gov. A copy of the prospectus relating to the offering may also be accessed through the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sales of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 13, 2020 NTN Buzztime, Inc. (NYSE American: NTN) and Brooklyn ImmunoTherapeutics LLC ("Brooklyn"), a privately-held biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, reported that the companies have entered into a definitive merger agreement (Press release, Brooklyn ImmunoTherapeutics, AUG 13, 2020, View Source [SID1234577221]). If approved by the stockholders of NTN Buzztime and the beneficial holders of the Class A membership interests of Brooklyn, Brooklyn will merge with a wholly-owned subsidiary of NTN Buzztime in an all-stock transaction. Following closing, which the parties expect will occur in the fourth quarter of 2020, the combined company will continue under the Brooklyn ImmunoTherapeutics name and will focus on the advancement of Brooklyn’s program to further develop its cytokine-based drug for the treatment of various cancers.

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Brooklyn’s chief executive officer Ron Guido, MS, MS Pharm. Med., stated, "We are pleased to reach an agreement with NTN Buzztime for the proposed merger. This provides us with the opportunity, once the merger is completed, to have our shares traded in the public market and to expand our investor base, which we believe will increase our ability to advance our clinical development program exploring the treatment of certain cancers using derived cytokines. We expect this merger will also enable us to expand our resources and expertise to build momentum in our drug development program. We believe that the merger will provide benefit to both the members of Brooklyn and the stockholders of NTN Buzztime."

Mr. Guido continued: "Brooklyn is focused on exploring the role that IRX-2, a cytokine-based investigational therapy, can have on the immune system in treating patients with cancer. IRX-2’s active constituents, namely Interleukin-2 (IL-2) and other key cytokines, are postulated to signal, enhance and restore immune function suppressed by the tumor, thus enabling the immune system to attack cancer cells. Unlike existing recombinant IL-2 therapies, IRX-2 is naturally derived from human blood cells. This may potentially promote better tolerance, broader targeting, and natural molecular conformation leading to greater activity, and permit low physiologic dosing rather than high doses needed in existing IL-2 therapies. Our ongoing development program is specifically investigating use of IRX-2 in neoadjuvant (pre-surgical) and adjuvant (post-operative) treatment for advanced head and neck squamous cell cancer. IRX-2 has received both fast track designation and orphan drug designation from the FDA for this indication. Potential use of our product candidate in other cancer indications is also being evaluated in several investigator-sponsored trials. Finally, we are currently modifying our manufacturing process to allow us to develop additional drugs with a variety of cytokine mixtures to expand our product offerings."

Allen Wolff, chief executive officer of NTN Buzztime, stated, "This transaction reflects the continuing commitment of our management team and board of directors to deliver value to our stockholders. Following a thorough review of strategic alternatives, we determined that the proposed merger with Brooklyn is in the best interest of our stockholders. We are also continuing to explore the sale of substantially all of the assets of our current business to provide additional capital and to allow the combined company to focus exclusively on Brooklyn’s business following the merger. While we are in discussions with multiple parties who are interested in purchasing those assets, no definitive agreement has been entered into to date."

About the Proposed Merger

Under the merger agreement, immediately following the closing of the merger, the members of Brooklyn collectively will own 94.08% of the outstanding common stock of the combined company and NTN Buzztime stockholders immediately prior to the closing of the merger collectively will own 5.92% of the outstanding common stock of the combined company, which percentages are subject to adjustment based on Brooklyn’s cash and cash equivalents and NTN Buzztime’s net cash balance at the closing, all as more particularly set forth in the merger agreement.

The merger agreement contains customary representations, warranties and covenants made by NTN Buzztime and Brooklyn, including covenants relating to both parties using their best efforts to cause the transactions contemplated by the merger agreement to be satisfied, covenants regarding obtaining the requisite approvals of NTN Buzztime stockholders and the beneficial holders of the Class A membership interests of Brooklyn, covenants regarding indemnification of directors and officers, and covenants regarding NTN Buzztime’s and Brooklyn’s conduct of their respective businesses between the date of signing of the merger agreement and the closing. The merger agreement also contains certain termination rights for both NTN Buzztime and Brooklyn, and, in connection with the termination of the merger agreement under specified circumstances, NTN Buzztime and Brooklyn may be required to pay the other party a termination fee.

As a condition to the closing of the merger, Brooklyn has agreed that it will not have less than $10 million in cash and cash equivalents and not more than $750,000 of indebtedness for borrowed money at the closing. Certain beneficial holders of Brooklyn’s Class A membership interests have entered into contractual commitments to invest $10 million into Brooklyn immediately prior to the closing of the merger. Further, as a condition to the closing of the merger, NTN has committed that the deficit in its net cash at the closing, as calculated under the merger agreement, will not exceed $3 million.

The combined company, led by Brooklyn’s current management team, is expected to be named "Brooklyn ImmunoTherapeutics, Inc." and be headquartered in Brooklyn, NY. After the closing, the combined company is expected to trade on the NYSE American market under a new ticker symbol.

The merger agreement has been unanimously approved by the board of directors of NTN Buzztime, upon the recommendation of its strategic committee, and by the managers of Brooklyn. The NTN Buzztime board of directors have also recommended to NTN Buzztime’s stockholders that they vote to approve issuance of the shares to the members of Brooklyn pursuant to the merger agreement, and the managers of Brooklyn have recommended to the beneficial holders of the Class A membership interests of Brooklyn that they approve the merger agreement and the merger. The transaction is expected to close in the fourth quarter of 2020, subject to approvals by the requisite stockholders of NTN Buzztime and beneficial holders of the Class A membership interests of Brooklyn described above, the continued listing of the combined company on the NYSE American, each of the company’s meeting its capitalization or net cash condition, as applicable, and other customary closing conditions.

In connection with the transaction, Maxim Group LLC is serving as the financial advisor for Brooklyn and Newbridge Securities Corporation is serving as the financial advisor to NTN Buzztime. Further, Breakwater Law Group, LLP and Sheppard, Mullin, Richter & Hampton LLP are serving as legal counsel to NTN Buzztime and Akerman LLP is serving as legal counsel to Brooklyn in connection with the transaction.

A more complete description of the terms of and conditions of the proposed merger and related matters will be included in a current report on Form 8-K to be filed by NTN Buzztime with the U.S. Securities and Exchange Commission ("SEC") on or about August 14, 2020. A copy of the merger agreement will be an exhibit to that Form 8-K. All parties desiring details regarding the terms and conditions of the proposed merger are urged to review that Form 8-K, and the exhibits attached thereto, which will be available at the SEC’s website at www.sec.gov.

On August 13, 2020 Genkyotex (Paris:GKTX) (Brussels:GKTX) (Euronext Paris & Brussels: FR0013399474 – GKTX), a biopharmaceutical company and the leader in NOX therapies (the "Company"), reported an agreement for Calliditas Therapeutics AB ("Calliditas"; Nasdaq OMX – CALTX; NASDAQ – CALT) to acquire a controlling interest in Genkyotex SA (Press release, GenKyoTex, AUG 13, 2020, View Source [SID1234576697]).

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Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.

Calliditas has agreed to acquire, through an off-market block trade, ordinary shares of Genkyotex representing 62.7% of the share capital and voting rights of Genkyotex1 from Genkyotex’s largest shareholders and management team (the "Block Sellers")2 for a cash consideration at closing of €2.80 per ordinary share (subject to certain transaction expenses) representing a 32.3% maximum premium on Genkyotex’s volume weighted average price (VWAP) over the preceding 10 trading days immediately prior to this announcement. In addition, the Block Sellers will receive non-transferable (subject to certain exceptions) contingent rights to additional cash payments on confirmation of regulatory approvals or marketing authorizations of setanaxib, as described below. The off-market block trade is expected to close in October 2020 and remains subject to customary conditions precedent, including the clearance from the French Minister of Economy and Finance regarding foreign investments in France. Calliditas will finance the block trade from its cash reserves.

Calliditas is seeking to acquire all outstanding Genkyotex shares and, as soon as reasonably practicable after and subject to completion of the off-market block trade, in compliance with French and Belgian securities law, Calliditas will file with the French Financial Market Authority (Autorité des Marchés Financiers – the "AMF") a mandatory simplified cash tender offer for the remaining Genkyotex shares on the same terms as the block trade (€2.80 per share in cash and contingent rights as further described below). Total acquisition cost would thus amount to a maximum of approximately €87.9m including contingent rights subject to future regulatory approvals of setanaxib.

The Block Sellers and the Genkyotex shareholders who tender their shares in the centralized tender offer will be eligible to additional cash payments (expressed in relation to 100% of the Genkyotex shares on a fully diluted basis on the day preceding the settlement and delivery of the tender offer) on confirmation of following regulatory approvals or marketing authorization of setanaxib no later than within ten years of the closing of the tender offer:

€30m on approval of setanaxib for a first indication by the US Food and Drug Administration (FDA);
€15m on approval of setanaxib for a first indication by the European Commission (EC); and
€10m on approval of setanaxib by the FDA or the EC for either idiopathic pulmonary fibrosis (IPF) or type 1 diabetes (unless such milestone has already been paid out for such indication by the FDA or the EC as per above).
In accordance with the provisions of article 261-1 I, II and III of the general regulations of the Autorité des marchés financiers, the Board of directors of Genkyotex, following the recommendation of an ad hoc committee composed of a majority of independent board members, has designated, BM&A Advisory & Support, represented by Pierre Béal as independent expert, who will be responsible for submitting a report on the financial terms and conditions of the proposed tender offer and potential squeeze-out offer.

Stifel acted as exclusive financial advisor to Genkyotex on this transaction. Mc Dermott Will & Emery acted as legal adviser to Genkyotex on this transaction.

On August 13, 2020 Biofrontera AG (shares of Biofrontera AG ISIN: DE0006046113) reported on July 27, 2020 the issuance of the 1.00% qualified subordinated mandatory convertible bond 2020/2021 with pre-emptive subscription rights for shareholders. 2,638,150 qualified subordinated mandatory convertible bearer bonds ("Bonds") with a nominal value of EUR 3.00 each (ISIN: DE000A3E4548 / WKN: A3E454) were offered for subscription at a subscription or placement price of 100% of their nominal value, corresponding to EUR 3.00 each in cash (Press release, Biofrontera, AUG 13, 2020, View Source [SID1234568549]). The subscription period ends on August 13, 2020.

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According to the current evaluation, all Bonds have been successfully placed – not considering the demand during the ongoing private placement.

On August 13, 2020 Acacia Pharma Group plc ("Acacia Pharma" or the "Company" and, together with its subsidiaries, the "Group") (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, reported its unaudited interim results for the six-month period ended 30 June 2020 (Press release, Acacia Pharma, AUG 13, 2020, View Source [SID1234568514]).

Mike Bolinder, CEO of Acacia Pharma, said: "The first half of 2020 was truly a transformative period for the Company. We were delighted to gain FDA approval for our first product, BARHEMSYS, in February. We identified and developed this product through an extensive and successful clinical trials program and it is testament to the founders and employees of the company for achieving this significant milestone.

"The in-licensing and subsequent US approval of BYFAVO added a second product to strengthen our portfolio targeting the anesthesiology market. We are now focused on building the optimal commercial organization to launch both products in the US, where we believe there is significant need for our new products.

"The coronavirus has created many challenges for the global healthcare system and supply chains. We believe it has also created opportunity for our products, and that we will see strong demand for both products given that they are designed in part to improve procedural throughput to help address the current surgical backlogs in hospitals and surgical centres that exist as a result of the pandemic. We also believe that in making these new products available, we can satisfy the demand for products addressing PONV and procedural sedation owing to shortages of supply that currently exist for the current standard-of-care drugs for these indications.

"Our focus is now wholly on executing a successful launch of BARHEMSYS and BYFAVO in 2H 2020, which will further accelerate our transition from an R&D-led company into a commercial business bringing much needed treatments to patients in the US. We look forward to an exciting time ahead and to providing further updates on our progress."

Operating Highlights (including post-period updates)

On 26 February 2020, the US Food and Drug Administration (FDA) approved the New Drug Application (NDA) for BARHEMSYS (amisulpride injection), the Company’s first product approval, allowing its commercialization in the US for the treatment and prevention of postoperative nausea and vomiting (PONV).
The label is the first to include rescue treatment in patients who have failed prior prophylaxis, and also includes combination prophylaxis with other antiemetics in higher risk patients, the two key commercial unmet needs.
On 27 July 2020, FDA approved a second supplier for the active pharmaceutical ingredient (API) for BARHEMSYS, supporting the Group’s ability to provide a continuous, high-quality product supply to meet the anticipated ongoing demand.
On 2 July 2020, FDA approved the NDA for the Group’s second product, BYFAVO (remimazolam), a rapid onset/offset IV benzodiazepine sedative for injection, for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less, such as colonoscopy and bronchoscopy.
BYFAVO was in-licensed on 10 January 2020 from Cosmo Technologies Limited (Cosmo) as part of a strategic agreement that also involved Cosmo making an equity investment in Acacia Pharma and providing a debt facility to the Group to finance the US commercialization of BARHEMSYS and BYFAVO.
On 1 June 2020, the Company announced that €10m of the overall Cosmo debt facility had been replaced by a €10m equity investment.
With effect from 7 August 2020, the Group was assigned the US license to BYFAVO by Cosmo with the consent of PAION UK Limited, thereby establishing a direct relationship between the originator of remimazolam and the Group as its US commercialization partner.
US infrastructure established in preparation for launch of BARHEMSYS and BYFAVO in 2H 2020.
The Company has assembled a highly experienced commercial leadership team with proven success in commercializing specialty pharmaceutical products to anaesthetists, surgical teams and directors of pharmacy – the target customers for BARHEMSYS and BYFAVO.
With both products approved, the Company is advancing its plans to build an initial hospital sales force and support staff ahead of launch in the 2H 2020.
The Company believes that the procedural backlogs and standard-of-care drug shortages, as a result of the coronavirus situation, have created potential pent-up demand for drugs such as BARHEMSYS and BYFAVO.
The Company announced changes to its senior management team and Board of Directors during 1H 2020 as part of its planned transition into a commercial-stage company.
With effect from 1 March 2020, Gary Gemignani was appointed Chief Financial Officer, succeeding Christine Soden who stepped down from the role and retired from the Board of Directors.
At the Annual General Meeting (AGM) on 7 April 2020, Scott Byrd was elected Chairman and Alessandro Della Chà, Chief Executive Officer and Director of Cosmo, was elected as a Non-Executive Director.
Patrick Vink (former Chairman), Pieter van der Meer and Johan Kördel (both former Non-Executive Directors) previously announced their intentions not to stand for re-election and stepped down from the Board at the AGM.

Financial Highlights

Cash and cash equivalents were $24.6m at 30 June 2020 (31 December 2019: $17.0m, 30 June 2019: $22.7m).
Operating loss for the period remained flat at $12.8m (1H 2019: $12.8) as the Group transitions from an R&D-led business towards the launch and commercialization of BARHEMSYS and BYFAVO.
G&A costs increased $2.2m in 1H 2020 to $4.4m (1H 2019: $2.2m) as a result of increased legal and other costs mainly related to the transactions with Cosmo Pharmaceuticals.
R&D costs in the 1H 2020 decreased to $0.6m (1H 2019: $2.5m) due to costs in the prior year attributed to activities preparing the NDA for BARHEMSYS.
Basic loss per share $0.24 (H1 2019: $0.25).

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