Ascelia Pharma AB (publ) (ticker: ACE) today published its Q4 and Full Year Report for 2023 (January - December), which is now available on the company's website: https://www.ascelia.com/ir-media/financial-reports/
KEY EVENTS IN Q4 2023
- Ascelia Pharma gets acceptance for publication of Orviglance® review article in Investigative Radiology
- Conversion of series C shares into ordinary shares for delivery to participants in incentive program and subsequent change in number of shares and votes
- Extraordinary General Meeting held on November 13, 2023 resolved on proposal to introduce an employee stock option program
- Ascelia Pharma starts image reading phase and re-confirms Phase 3 SPARKLE results by May 2024
KEY EVENTS AFTER THE PERIOD
- Nomination Committee appointed for the Annual General Meeting 2024
- Orviglance review article is published in Investigative Radiology
- Ascelia Pharma secures financing of up to SEK 35 million
FINANCIAL SUMMARY Q4 (Oct - Dec) 2023
- Operating result of SEK -11.1M (SEK -52.2M)
- Earnings per share of SEK -0.31 (SEK -1.53)
- Cash flow from operations of SEK -15.9M (SEK -28.7M)
- Liquid assets and marketable securities of SEK 21.9M (SEK 149.6M)
FINANCIAL SUMMARY FULL YEAR (Jan - Dec) 2023
- Operating result of SEK -110.9M (SEK -147.0M)
- Earnings per share of SEK -3.24 (SEK -3.77)
- Cash flow from operations of SEK -126.8M (SEK -125.3M)
- Liquid assets and marketable securities of SEK 21.9M (SEK 149.6M)
"In 2023, our focus was on SPARKLE, the pivotal Phase 3 study for our orphan magnetic resonance imaging (MRI) contrast agent for liver imaging, Orviglance®. We successfully completed patient enrollment in March. In early August, the discovery of high intra-reader variability in the study image scoring by independent radiologists prevented us from evaluating the efficacy data from SPARKLE. Therefore, a new evaluation of the images with new independent readers was required. With the aim of reaching headline results with available funding, we focused all resources on the re-evaluation and implemented cost-cutting initiatives, including a significant reduction of the organization. In September, we shared our plan to complete the re-evaluation and reach headline results from SPARKLE by May 2024. In addition, we expanded the commercialization strategy for Orviglance to also consider launching in the US with a partner. Early December, we communicated that the image reading process had started according to plan, putting us on track for the May 2024 headline results read-out. While the re-evaluation was a regrettable setback on our timelines, it does not change our high confidence in Orviglance, nor does it change the global medical need for a liver imaging contrast agent without gadolinium. On 4 February 2024, we were pleased to announce that we secured a directed issue of convertibles raising gross proceeds of SEK 15 million and an agreement for a loan facility of up to SEK 20 million, extending our cash runway into Q2 2025 with the full financing. This strengthened financial position is an important and value-adding step to maintain financial and strategic flexibility. We are also very pleased to be able to secure a financing solution with a maximum dilution of only around 4 percent for our shareholders. We look very much forward to executing on the opportunities ahead for Ascelia Pharma in 2024 and beyond - starting with the announcement of headline results by May.", said Magnus Corfitzen, CEO at Ascelia Pharma.
A presentation for analysts, investors and media will be held today 9 February at 10:00am CET. The event will be hosted by the company's CEO Magnus Corfitzen, Deputy CEO Julie Waras Brogren, and CSO Andreas Norlin. The presentation will be held in English. The presentation can be followed live via the link:
https://ir.financialhearings.com/ascelia-pharma-q4-report-2023
To participate via teleconference, please register through the link below. After registration, you will be provided with phone numbers and a conference ID to access the conference.
https://conference.financialhearings.com/teleconference/?id=50047318
It will also be possible to access the audiocast afterwards at the same address or on the website of Ascelia Pharma: https://www.ascelia.com/ir-media/
Contacts
Magnus Corfitzen, CEO
Email: moc@ascelia.com
Tel: +46 735 179 118
Julie Waras Brogren, Deputy CEO (Finance, Investor Relations & Commercial)
Email: jwb@ascelia.com
Tel: +46 735 179 116
This information was submitted for publication, through the agency of the contact persons set out above.
About Us
Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates - Orviglance (previously referred to as Mangoral) and Oncoral - in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit http://www.ascelia.com.
About Orviglance (previously referred to as Mangoral)
Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A clinical program of nine studies, including the pivotal global Phase 3 study SPARKLE, has been completed. Results from the Phase 3 study are not yet available.
About Oncoral
Oncoral is a novel irinotecan chemotherapy tablet developed initially for the treatment of gastric cancer. Irinotecan chemotherapy has an established potent anti-tumor effect. Oncoral is a daily tablet with the potential to offer better patient outcomes with improved safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital. Following successful Phase 1 results, Oncoral is now prepared for Phase 2 clinical development.
