COPA

Spexis announces closing of capital commitment of USD 4.5 million from SPRIM Global Investments (SGI) to enable initiation of ColiFin® Phase 3 study

Retrieved on: 
Tuesday, April 18, 2023

ALLSCHWIL, Switzerland, April 18, 2023 (GLOBE NEWSWIRE) -- Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced that the company has finalized a capital commitment from SPRIM Global Investments (SGI) totaling USD 4.5 million in the form of secured, interest-bearing debt with partial warrant coverage and subordinated debt mandatorily converting into equity. Proceeds from the capital commitment will enable the initiation of the Phase 3 COPILOT study, the first part of the registrational clinical studies planned for ColiFin®. The COPILOT study, which will enroll 38 patients and evaluate and confirm the use of once or twice daily dosing for COPA, the second part of the planned pivotal efficacy and safety Phase 3 study of ColiFin®, has study start-up activities ongoing, and is expected to enroll its first patient in June 2023.

Key Points: 
  • Proceeds from the capital commitment will enable the initiation of the Phase 3 COPILOT study, the first part of the registrational clinical studies planned for ColiFin®.
  • The clinical development of ColiFin® is supported by FDA Orphan Drug, Qualified Infectious Disease Product (QIDP) and Fast Track Designations.
  • In addition, and as part of an ongoing strategic realignment, two members of Spexis’ executive committee will be transitioning out of the company.
  • Stephan Wehselau, currently Chief Operating Officer, will be leaving Spexis by the end of June.

Berkshire Biomedical to Present at the LSI USA '23 Emerging Medtech Summit

Retrieved on: 
Tuesday, March 14, 2023

DALLAS, March 14, 2023 /PRNewswire/ -- Berkshire Biomedical Corporation ("Berkshire" or the "Company"), focused on developing its proprietary drug dispensing technology to enhance patient wellness, announced today that John Timberlake, Chief Executive Officer, will present at the fourth annual Life Science Intelligence (LSI) USA '23 Emerging Medtech Summit on March 22, 2023, at 10:55 am PDT.

Key Points: 
  • DALLAS, March 14, 2023 /PRNewswire/ -- Berkshire Biomedical Corporation ("Berkshire" or the "Company"), focused on developing its proprietary drug dispensing technology to enhance patient wellness, announced today that John Timberlake, Chief Executive Officer, will present at the fourth annual Life Science Intelligence (LSI) USA '23 Emerging Medtech Summit on March 22, 2023, at 10:55 am PDT.
  • "Presenting at the LSI Emerging Medtech Summit provides an opportunity to showcase our proprietary, cloud-based, physician-enabled COPA device and the Company's initial focus on utilizing our technology to help more patients with Opioid Use Disorder gain access to take-home therapy," stated Mr. Timberlake.
  • We look forward to sharing the considerable progress the Company has made advancing the development of our COPA technology in preparation for filing a De Novo application with the FDA later this year."
  • Those attending the Emerging Medtech Summit who are interested in scheduling a one-on-one meeting with management, can utilize the meeting portal or can contact Michael Miller at [email protected] .

BITCOIN INVENTOR DR WRIGHT GRANTED PERMISSION TO SUE ROGER VER FOR DEFAMATION IN ANTIGUA

Retrieved on: 
Wednesday, March 1, 2023

LONDON, March 1, 2023 /PRNewswire/ -- Today in the High Court of Antigua and Barbuda, Dr Craig Wright, the inventor of Bitcoin - the world's first functioning and successful electronic cash system – was granted permission to continue his defamation proceedings against Bitcoin Cash (BCH) proponent, Roger Ver in the jurisdiction.

Key Points: 
  • LONDON, March 1, 2023 /PRNewswire/ -- Today in the High Court of Antigua and Barbuda, Dr Craig Wright, the inventor of Bitcoin - the world's first functioning and successful electronic cash system – was granted permission to continue his defamation proceedings against Bitcoin Cash (BCH) proponent, Roger Ver in the jurisdiction.
  • Both Dr Wright and Mr Ver are Antiguan citizens, and Mr Ver has a home in Antigua.
  • This followed a defamation claim by Dr Wright in Antigua, whose original English Court proceedings were eventually barred by jurisdiction.
  • Dr Wright was recently granted permission to appeal the Norwegian Court's finding that permitted Mr Granath's statements under Norwegian law.

BITCOIN INVENTOR DR WRIGHT GRANTED PERMISSION TO SUE ROGER VER FOR DEFAMATION IN ANTIGUA

Retrieved on: 
Wednesday, March 1, 2023

LONDON, March 1, 2023 /PRNewswire/ -- Today in the High Court of Antigua and Barbuda, Dr Craig Wright, the inventor of Bitcoin - the world's first functioning and successful electronic cash system – was granted permission to continue his defamation proceedings against Bitcoin Cash (BCH) proponent, Roger Ver in the jurisdiction.

Key Points: 
  • LONDON, March 1, 2023 /PRNewswire/ -- Today in the High Court of Antigua and Barbuda, Dr Craig Wright, the inventor of Bitcoin - the world's first functioning and successful electronic cash system – was granted permission to continue his defamation proceedings against Bitcoin Cash (BCH) proponent, Roger Ver in the jurisdiction.
  • Both Dr Wright and Mr Ver are Antiguan citizens, and Mr Ver has a home in Antigua.
  • This followed a defamation claim by Dr Wright in Antigua, whose original English Court proceedings were eventually barred by jurisdiction.
  • Dr Wright was recently granted permission to appeal the Norwegian Court's finding that permitted Mr Granath's statements under Norwegian law.

Statement of Elizabeth Wilkins, Director of the FTC’s Office of Policy Planning, on the Decision of SUNY Upstate Medical University and Crouse Health System, Inc. to Drop Their Proposed Merger

Retrieved on: 
Monday, February 20, 2023

In 2017, the FTC announced a policy project to assess the impact of COPAs on prices, quality, access, and innovation for health care services.

Key Points: 
  • In 2017, the FTC announced a policy project to assess the impact of COPAs on prices, quality, access, and innovation for health care services.
  • The studies of past COPAs have revealed significant increases in commercial inpatient prices, as well as declines in quality of care.
  • Promoting competition in the healthcare sector is a key priority for the FTC, including preventing anticompetitive hospital mergers.
  • For the latest news and resources, follow the FTC on social media, subscribe to press releases and read our blog.

Statement of Elizabeth Wilkins, Director of the FTC’s Office of Policy Planning, on the Decision of SUNY Upstate Medical University and Crouse Health System, Inc. to Drop Their Proposed Merger

Retrieved on: 
Monday, February 20, 2023

In 2017, the FTC announced a policy project to assess the impact of COPAs on prices, quality, access, and innovation for health care services.

Key Points: 
  • In 2017, the FTC announced a policy project to assess the impact of COPAs on prices, quality, access, and innovation for health care services.
  • The studies of past COPAs have revealed significant increases in commercial inpatient prices, as well as declines in quality of care.
  • Promoting competition in the healthcare sector is a key priority for the FTC, including preventing anticompetitive hospital mergers.
  • For the latest news and resources, follow the FTC on social media, subscribe to press releases and read our blog.

Spexis and SPRIM Global Investments (SGI) Announce Plans for Clinical Trial Partnership to Fund up to Half of the Projected Phase 3 Clinical Development Costs of ColiFin®

Retrieved on: 
Wednesday, February 8, 2023

ALLSCHWIL, Switzerland, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced that the Company has executed term sheets describing a clinical trial partnership with SPRIM Global Investments (SGI), a leading health sciences venture capital firm with deep industry expertise and decades of operating experience across 17 countries. The partnership, which includes a debt facility, is expected to provide Spexis with up to half of the Phase 3 clinical development costs of ColiFin® and enable the initiation of Spexis’ Phase 3 COPILOT study, expected in the second quarter of 2023. COPILOT will evaluate and confirm the use of once versus twice daily dosing for COPA, the planned single pivotal efficacy and safety Phase 3 trial. While the majority of such funding is planned to be in the form of senior debt tied to the funding of the COPILOT and COPA studies, SGI has also invested in Spexis via an interest-bearing subordinated convertible note financing in an amount of $500,000, with a term of 2 years and partial warrant coverage. Spexis expects to secure additional investors in the near future.

Key Points: 
  • The partnership, which includes a debt facility, is expected to provide Spexis with up to half of the Phase 3 clinical development costs of ColiFin® and enable the initiation of Spexis’ Phase 3 COPILOT study, expected in the second quarter of 2023.
  • COPILOT will evaluate and confirm the use of once versus twice daily dosing for COPA, the planned single pivotal efficacy and safety Phase 3 trial.
  • “This collaboration is expected to provide capitalization through significant clinical milestones in ColiFin®’s Phase 3 development.
  • Spexis has worldwide rights to ColiFin® ex-Europe and is focused on developing the product first for the U.S. market.

Addex Increases Issued Share Capital to Create Treasury Shares

Retrieved on: 
Tuesday, November 1, 2022

The new shares, issued from the Companys authorized capital, are listed on the SIX Swiss Exchange.

Key Points: 
  • The new shares, issued from the Companys authorized capital, are listed on the SIX Swiss Exchange.
  • The total number of issued shares increased to 97,909,428 at a nominal value of CHF 0.01 each, whilst the outstanding shares remain unchanged.
  • 135 FMIA in respect of all listed shares of Addex Therapeutics Ltd in connection with the transaction described in this decision.
  • Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol "ADXN" on each exchange.

FTC Staff Opposes Proposed Certificate of Public Advantage That Could Shield SUNY Upstate Medical University’s Acquisition of Crouse Health System from Antitrust Scrutiny

Retrieved on: 
Monday, October 31, 2022

SUNY Upstate Medical University and Crouse Health System announced the proposed merger in April 2022, then filed a COPA application in July.

Key Points: 
  • SUNY Upstate Medical University and Crouse Health System announced the proposed merger in April 2022, then filed a COPA application in July.
  • The New York State Department of Health has invited public comments on the application.
  • Moreover, the proposed merger between SUNY Upstate and Crouse would reduce the number of hospital options available for nearly all patients in Onondaga County from three to two.
  • FTC staff submitted a public version and non-public version of its comment, with claimed confidential material redacted from the public version.