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    ACE   SE0010573113

ASCELIA PHARMA AB (PUBL)

(ACE)
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Ascelia Pharma : Covid-19 extends recruitment period of SPARKLE study

08/18/2021 | 01:11pm EST

Ascelia Pharma AB (publ) (ticker: ACE) today announced that the continued global impact of the Covid-19 pandemic could extend the recruitment period of the clinical phase 3 study SPARKLE with up to 6 months. The recruitment is now expected to be completed during H1 2022. Ascelia Pharma has a solid cash position supporting operations well into 2023.

Ascelia Pharma is making steady progress in the ongoing pivotal Phase 3 SPARKLE study with its lead compound Orviglance (former working name Mangoral). Nevertheless, the Covid-19 pandemic continues to substantially impact healthcare systems globally, including the conduct of clinical trials. Especially in the U.S., an important country in the SPARKLE study, the increasing infection rates are impacting clinical study activities. In this context, the company expects that the recruitment timeline could be extended up to 6 months into H1 2022 (previously H2-2021).

“Covid-19 has continued to be a challenge for clinical research globally since the outbreak early 2020. Some patients cannot or are unwilling to visit hospitals for clinical tests. Our SPARKLE study is no exception. We have adapted our operational procedures including adding more study sites and made good progress despite the pandemic. However, the continued high infection rates in countries where SPARKLE is ongoing are negatively impacting study sites’ ability and recruitment pace to conduct clinical research and patient enrollment as planned. Our team, together with our study sites, continue to assess and implement possible mitigations to accelerate patient recruitment”, said Carl Bjartmar, Chief Medical Officer at Ascelia Pharma.

“The medical need for a safe and effective liver specific contrast agent is strong and the value that Orviglance can provide to patients and the healthcare system is significant. We are committed to bringing Orviglance to the patients in need and we have a strong cash position well into 2023 providing a solid foundation”, said Magnus Corfitzen, CEO of Ascelia Pharma.

Following the completion of the SPARKLE study, Ascelia Pharma plans to submit a New Drug Application to the FDA with a subsequent launch expected in H2 2023.

© Modular Finance, source Nordic Press Releases

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Financials
Sales 2020 - - -
Net income 2020 -98,7 M -10,8 M -10,8 M
Net cash 2020 183 M 20,0 M 20,0 M
P/E ratio 2020 -15,0x
Yield 2020 -
Capitalization 1 010 M 111 M 110 M
EV / Sales 2019 -
EV / Sales 2020 -
Nbr of Employees 12
Free-Float 84,0%
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Number of Analysts 0
Last Close Price 30,00 
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Managers and Directors
Magnus Olafsson Corfitzen Chief Executive Officer
Kristian Borbos Chief Financial Officer
Peter James Arthur Benson Chairman
Carl Bjartmar Chief Medical Officer
Bo Jesper Hansen Independent Director
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