Santhera Presents Options in Tender for Marketing Funds; Swiss biotech Covid work shrinks – Endpoints News

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As Santhera awaits the FDA’s signal on its continued NDA submission, the penny stock biotech is seeking more funding.

The Swiss biotech penny stock announced the next meeting on Friday morning, scheduled for November 29, saying it planned to advance its preparations to launch its vamorolone candidate for Duchenne muscular dystrophy, or DMD. But for that, he needs money.

This is the latest biotech update after Santhera announced last week, alongside partner ReveraGen BioPharma, that it had completed the ongoing submission of an NDA to US regulators and was seeking a priority review of vamorolone to treat Duchenne.

The biotech said it had access to treasury stock, capital from past shareholder authorizations and a cash balance of approximately $12.7 million as of June 2022. However, those assets would only provide a lead until the first quarter of 2023.

As Santhera pursues “strategic options” such as licensing agreements or debt financing, it is offering shareholders a “share capital increase” of 40 million shares so that it can obtain short-term financing. In addition to this, it is seeking to increase the authorized capital by CHF 100,000 until 2024 and an additional CHF 100,000 in conditional capital. — Paul Schlösser

Kinarus returns to non-Covid testing – looking at eye and lung indications

After jumping into the Covid-19 drug R&D arena, a Swiss biotech is back to its original plans.

Kinarus terminated a Phase II study in patients hospitalized with the pandemic disease in late September for KIN001. Now he is once again focusing on wet age-related macular degeneration and idiopathic pulmonary fibrosis.

The work in Covid-19 is not completely finished. KIN001 is still being tested in a mid-term study in non-hospitalized patients. With a different patient population, Kinarus thinks the Swiss government-backed program could be successful compared to the other pandemic trial.

“Now that it is again possible to conduct clinical trials in indications other than Covid – which was not the case at the height of the pandemic – we are refocusing the efforts of our team on our initial objective of conducting clinical trials. Phase 2 clinical trials of KIN001 in wAMD and IPF patients,” CEO Alexander Bausch said in a statement. “We are exploring all options to advance KIN001 into Phase 2 clinical trials in these indications.”

IPF has two approved treatments, both approved in 2014, and several biotechs are trying to fill the gaps or improve Ofev and Esbriet.

Pamapinod, one of the two components of Kinarus’ drug, is licensed by Roche for all indications. The p38 MAP kinase inhibitor, a class that has seen several late-stage efforts abandoned due to sustainability issues. —Kyle Lahucik

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