On April 8, 2020 Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported its full-year audited results for the year ended December 31, 2019 and provided a corporate update (Press release, Addex Therapeutics, APR 8, 2020, View Source [SID1234561372]).

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"We made significant progress in 2019 in advancing our pipeline of innovative in-house discovered allosteric modulators, including our priority dipraglurant levodopa-induced dyskinesia program, which is ready to start dosing patients in a pivotal registration clinical trial as soon as the Covid-19 crisis is over," said Tim Dyer, CEO of Addex. "We also achieved important milestones in our GABAB PAM collaboration with Indivior and secured funding from Eurostars/Innosuisse to advance our mGlu7NAM program for PTSD as well as completing the listing of American Depositary Shares (ADSs) on the Nasdaq Stock Market."

2019 Operating Highlights:

Dipraglurant pivotal phase 2b/3 clinical trial expected to dose first patient in H2 2020 and readout topline results in Q2 2022
Indivior funded GABAB PAM research program on track to deliver drug candidates by end of 2020
Addex led consortium awarded Eurostars grant of €4.85 million to fund discovery of mGlu7 NAM drug candidates for post-traumatic stress disorder
Completed 2019 with a strong liquidity position of CHF31.5 million of cash and cash equivalents
Listed American Depositary Shares (ADS) representing our ordinary shares on the Nasdaq Stock Market on January 29, 2020
Key 2019 Financial Data:

Financial Summary:

Revenue decreased by CHF 3.2 million to CHF 2.8 million in 2019 compared to CHF 6.0 million in 2018, primarily due to the absence of the USD 5.0 million (CHF4.8 million) upfront payment received from Indivior in January 2018 but partially offset by the increase in collaborative research funding from Indivior PLC.

Other income decreased by CHF 0.6 million to CHF 0.1 million in 2019 compared to CHF 0.7 million in 2018, primarily due to the absence of MJFF research grants recognized in 2018. In 2019, research grants relate to amounts recognized under our Eurostars/Innosuisse grant.

Research and development expenses increased by CHF7.5 million to CHF 12.4 million in 2019 compared to CHF 4.9 million in 2018, mainly due to an increase in outsourced development costs related to our dipraglurant PD-LID program and to a lesser extent our GABAB PAM program. R&D expenses consist primarily of costs associated with research, preclinical and clinical testing, and related staff costs. They also include depreciation of laboratory equipment, costs of materials used in research, costs associated with renting and operating facilities and equipment, as well as fees paid to consultants, patent costs and other outside service fees and overhead costs. These expenses include costs for proprietary and third party R&D.

G&A expenses increased by CHF 1.8 million to CHF 5.0 million in 2019, compared to CHF 3.2 million in 2018, mainly due to the increase in headcount and costs related to preparing the listing of ADSs representing our shares on the Nasdaq Stock Market.

The net loss for 2019 was CHF 14.8 million compared to CHF 1.6 million for 2018. Basic and diluted loss per share increased to CHF 0.56 for 2019, compared to CHF 0.07 for 2018.

Cash and cash equivalents amounted to CHF 31.5 million at December 31, 2019 compared to CHF 41.7 million at December 31, 2018. This decrease of CHF 10.2 million is mainly due to the net loss of CHF 14.8 million, adjusted for changes in net working capital of CHF 2.9 million and non-cash items of CHF 2.1 million. Non-cash items relate mainly to the value of share-based services. Changes in working capital relate mainly to an increases of CHF1.1 million and CHF0.9 million in payables and accruals, respectively that are primarily related to our dipraglurant PD-LID program and professional service fees related to our recent listing of ADSs on the Nasdaq stock market, as well as CHF 0.7 million of increased contract liabilities related to our funded research contract with Indivior.

2019 Annual Report:
The 2019 annual report can be found on the investor relations page of our website

Conference Call Details:
A conference call will be held today, April 8, 2020, at 16:00 CEST (15:00 BST / 10:00 ET) to review the financial results. Tim Dyer, Chief Executive Officer, Roger Mills, Chief Medical Officer, Jean-Philippe Rocher, Head of Discovery Chemistry and Robert Lütjens, Head of Discovery Biology will deliver a brief presentation followed by a Q&A session.

Link to live event online:
1: In the 10 minutes prior to the call start time, sign in online by following this link Webex Link.
2: Password: Welcome

On April 8, 2020 SOM Biotech reported its management team with the appointment of Catherine Scart as Chief Medical Officer and Kevin McAllister as Chief Scientific Officer (Press release, SOM Biotech, APR 8, 2020, View Source;utm_medium=rss&utm_campaign=som-biotech-strengthens-its-management-team [SID1234558681]).

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Therefore, Catherine Scart MD will join SOM Biotech management team as Chief Medical Officer and will assume responsibility for the company´s clinical trials and lead the pipeline development with a special focus on leveraging on SOMs proprietary technology to develop valuable drug candidates. Prior to joining SOM Biotech, Catherine Scart served as Head of Clinical Development at Bioproject, a French R&D company where she led the clinical development plan and ensured the execution of clinical trials, particularly in the areas of neurodegenerative and orphan diseases. Catherine Scart has a strong background working for international biopharmaceutical companies providing key medical and scientific support to launch innovative compounds, managing all processes needed to ensure the effective and successful completion of the companies´ pipeline development strategy.

Kevin McAllister PhD MBA will join SOM Biotech management team as Chief Scientific Officer, contributing with his extensive experience in drug discovery and development to strengthen the nonclinical and clinical scientific and technical expertise. Kevin McAllister joins SOM Biotech from Neurenable GmbH, where he was Managing Director and consulting to biotech in the EU and USA. Prior to this Kevin was Executive Director in the Neuroscience Disease Area at Novartis Institutes for Biomedical Research, and Principal Medical Scientific Expert in the Novartis Neuroscience Clinical Development Franchise.

Raul Insa, CEO of SOM Biotech: "I´m delighted that Catherine and Kevin are joining SOM Biotech. Both bring very valuable and extensive experience to complement the expertise of our existing team. They will play a key role as we continue with the progress of our pipeline and with the implementation of our strategic plan to grow and position SOM Biotech as a leading biopharma worldwide".

On April 8, 2020 T-Cure Bioscience, Inc., a privately held company focused on developing autologous T cell receptor (TCR) therapy products for the treatment of solid tumors, reported that the Company has entered into an exclusive, worldwide license with the National Cancer Institute (NCI) for intellectual property related to a TCR-based product candidate for the treatment of Kita-Kyushu lung cancer antigen 1 (KK-LC-1) expressing malignancies, such as gastric, lung, and breast cancers (Press release, T-Cure Bioscience, APR 8, 2020, View Source [SID1234556951]). T-Cure anticipates the KK-LC-1 TCR therapy will enter a multi-site Phase 1 clinical study in the third quarter of 2020 under the direction of Christian S. Hinrichs, M.D., Principal Investigator at the Experimental Transplantation and Immunology Branch (ETIB) at NCI.

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To support the preclinical and clinical research to develop the TCR product and future products targeting KK-LC-1, T-Cure has entered into a Cooperative Research and Development Agreement (CRADA) with the NCI. Under the CRADA, T-Cure will work to identify additional therapy candidates targeting KK-LC-1 using the Company’s proprietary TCR discovery platform, iSORT. The Company also intends to conduct an independent Phase 1 clinical trial in 2021 to further assess the safety and efficacy of the licensed KK-LC-1 TCR.

"The KK-LC-1 TCR technology forms the foundation of a new treatment strategy for a certain common, difficult to treat cancers," stated NCI’s Dr. Hinrichs.

"We are extremely excited to work with Dr. Hinrichs and his team at NCI to advance this novel TCR product candidate through preclinical and clinical development," stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. "Dr. Hinrichs’ extensive experience in the discovery and development of novel adoptive T-cell therapies for cancer will be invaluable as we advance this program. Of note, the TCR was isolated from the tumor-infiltrating lymphocytes of a patient who had a complete response to an immunotherapy without any toxicities. As a result, we believe it holds great promise for engineering patients’ immune cells to effectively target and destroy cancer cells without harming healthy tissue."

On April 8, 2020 Biogen Inc. (Nasdaq:BIIB) reported it will report first quarter 2020 financial results Wednesday, April 22, 2020, before the financial markets open (Press release, Biogen, APR 8, 2020, View Source [SID1234556232]).

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Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website.

On April 8, 2020 Cytokinetics, Incorporated (Nasdaq:CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at the 19th Annual Needham Virtual Healthcare Conference on Wednesday, April 15, at 10:40 AM EST (Press release, Cytokinetics, APR 8, 2020, View Source [SID1234556231]).

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Interested parties may access the live webcast of this presentation by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of the presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.