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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On August 13, 2020 Acacia Pharma Group plc ("Acacia Pharma" or the "Company") (EURONEXT: ACPH), a commercial stage biopharmaceutical company reported that focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, intends to issue new ordinary shares of a nominal value of £0.02 (the "New Ordinary Shares") raising gross proceeds of approximately EUR 25m ($30m), by means of an accelerated bookbuild offering (the "Placing") (Press release, Acacia Pharma, AUG 13, 2020, View Source [SID1234568513]).

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The price at which the New Ordinary Shares will be issued (the "Placing Price") and the total number of New Ordinary Shares to be issued in the Placing will be determined by way of an accelerated bookbuild process (the "Bookbuild"). The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate structure for the Company at this time, allowing it to raise capital in a timely and cost-effective manner and to diversify the shareholder base.

Jefferies International Limited ("Jefferies") and Guggenheim Securities, LLC ("Guggenheim Securities") are acting as Joint Global Coordinators and Joint Bookrunners and Bank Degroof Petercam SA/NV ("Degroof Petercam") is acting as Joint Bookrunner and Listing Agent (Jefferies, Guggenheim Securities and Degroof Petercam together, the "Joint Bookrunners" or the "Banks") in connection with the Placing.

The Bookbuild will start immediately following this announcement. Pricing and allocation of the New Ordinary Shares in the Placing is expected to take place before beginning of trading on Euronext Brussels at 09:00 CEST on 14 August 2020. The exact timing of closing of the Bookbuild, pricing and allocation is at the discretion of the Company and the Joint Global Coordinators and Joint Bookrunners. The Company will announce the outcome of the Placing after closing of the Bookbuild in a subsequent announcement.

The Company has requested the Belgian Financial Services and Markets Authority ("Belgian FSMA") to suspend trading in Acacia Pharma’s shares on Euronext Brussels during the Bookbuild. Trading in the shares is expected to resume following the publication of the results of the Placing.

The Company has separately announced today its interim results for the six months ended 30 June 2020 (the "Interim Results Announcement"). This announcement should be read in conjunction with the Interim Results Announcement.

The net proceeds of the Placing are intended to be used for:
(i) the recruitment of an initial sales force of approximately 30, with an additional ten support staff; NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN AND SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH PUBLICATION, DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR OTHER MEASURES
2 (ii) payment of marketing costs relating to BARHEMSYS and BYFAVO including brand development and engagement with key opinion leaders, healthcare professionals and medical conference and speaker programmes;
(iii) the implementation of post-approval research and development commitments including paediatric studies for BARHEMSYS and BYFAVO and a renal study for BARHEMSYS;
(iv) satisfaction of interest and capital payments under existing loan agreements; and
(v) general corporate purposes relating to ongoing commercial activities as well as supplementing existing stock of both BARHEMSYS and BYFAVO.

In connection with the Placing, the Company has agreed, pursuant to a lock-up undertaking, not to issue additional shares for a period of 90 days following settlement of the Placing. In addition, in connection with the Placing, senior managers and directors of the Company as well as Cosmo Technologies Limited, a substantial shareholder in the Company, have agreed not to sell any shares in Acacia Pharma for a period of 90 days following the settlement of the Placing, subject to customary exceptions.

Your attention is drawn to the detailed terms and conditions of the Placing described in Appendix I to this announcement (which form part of this announcement). The attention of investors is drawn in particular to the "Conditions of the Placing and Termination of the Placing Agreement" section of Appendix I (including the condition that no Material Adverse Change can have occurred immediately prior to the Closing Date and, in respect of termination of the Placing Agreement, the various applicable force majeure events set out therein).

Capitalised terms used but not otherwise defined in the text of this announcement are defined in Appendix II of this announcement.

On August 13, 2020 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA) (the Company or Ayala), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported financial results for the second quarter ended June 30, 2020 and highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Ayala Pharmaceuticals, AUG 13, 2020, View Source [SID1234563990]).

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"Our successful IPO in the second quarter represents an important step for Ayala as we work to make meaningful strides across our exciting programs. With a well-capitalized foundation on which to further develop our novel pipeline of therapies for genetically defined cancers, we are poised to execute across multiple milestones in the remainder of 2020 and through the first half of 2021," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "We are looking forward to presenting new interim data from our Phase 2 ACCURACY study of AL101 for the treatment of ACC in September 2020, while also continuing to dose patients in the 6mg dose cohort of the study. Now more than ever, the need for innovation and drug development is evident and we are pleased by the additional clinical progress we have made to-date. This quarter our IND was accepted for our Phase 2 TENACITY study of AL101 monotherapy in patients with recurrent or metastatic triple negative breast cancer who have undergone up to three prior lines of therapy and we are on track to begin dosing patients this year."

Key Business and Clinical Highlights

Phase 2 TENACITY Study of AL101 For Treatment of Triple Negative Breast Cancer: In April 2020, the U.S. Food and Drug Administration (FDA) accepted the investigational new drug application (IND) for the Phase 2 TENACITY study of AL101 for the treatment of Triple Negative Breast Cancer (TNBC). The FDA approved the dosing to commence at 6mg in a monotherapy study to evaluate TNBC patients bearing Notch activating mutations who have undergone 3 or fewer prior lines of therapy. Ayala has opened its first U.S. clinical site for the study.
Upcoming Milestones

New Interim Data from Phase 2 ACCURACY Study of AL101 for the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma to be Presented at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020: Ayala will provide an oral presentation of new interim data from its ongoing Phase 2 ACCURACY study of AL101 for the treatment of recurrent/metastatic adenoid cystic carcinoma (R/M ACC) harboring Notch activating mutations at the upcoming ESMO (Free ESMO Whitepaper) Virtual Congress 2020 on September 18, 2020, at 03:55 CEST.

On Track to Begin Patient Dosing in Phase 2 TENACITY Study of AL101 for the Treatment of TNBC: Ayala expects to initiate patient dosing before year-end 2020 in the Phase 2 TENACITY study of AL101 for the treatment of TNBC harboring Notch activating mutations.

On Track to Initiate Two Phase 2 Clinical Trials in 2021:

Phase 2 Study of AL102 for the Treatment of Desmoid Tumors: Ayala expects to initiate a Phase 2 study of AL102, a potent, selective, oral gamma secretase inhibitor, in patients with desmoid tumors, a category of rare, disfiguring and often debilitating soft tissue tumors, in the first half of 2021.

Phase 2 Study of AL101 for the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia: Based on findings from Ayala’s Phase 1 study of AL101 and supporting data from its preclinical studies, Ayala expects to initiate a Phase 2 study of AL101 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (R/R T-ALL), an aggressive and rare form of T-cell specific leukemia, in the first half of 2021.
Second Quarter 2020 Financial Results

Cash Position: Cash and cash equivalents were $57.4 million as of June 30, 2020, as compared to $16.7 million as of December 31, 2019. Ayala expects its existing cash balance to fund operations through multiple potential key clinical and development milestones into the second half of 2022.

Collaboration Revenue: Collaboration revenue was $1.0 million for the second quarter of 2020 compared to $0.9 million for the same period in 2019. The increase in revenue was attributed to the advancement of Ayala’s collaboration with Novartis for the development of AL102 in combination with Novartis’ anti-B-cell maturation antigen agent.

R&D Expenses: Research and development expenses were $5.1 million for the second quarter of 2020, compared to $3.4 million for the same period in 2019. The increase was primarily driven by additional costs in connection with the advancement of AL101 trials and other preclinical development.

G&A Expenses: General and administrative expenses were $1.5 million for the second quarter of 2020, compared to $1.0 million for the same period in 2019. The increase was primarily related to higher professional services and personnel costs to support the growth of the Company.

Net Income/Loss: Net loss was $6.7 million, or $0.74 loss per share, for the second quarter of 2020, compared to $3.8 million, or $0.76 loss per share, for the same period in 2019, mainly attributable to the advancement of the clinical trials and other preclinical development.