Ascelia Pharma AB (publ) (ticker: ACE) today published its Half-Year Report for 2024 (January - June), which is now available on the company's website: https://www.ascelia.com/ir-media/financial-reports/
KEY EVENTS IN Q2 2024
- SPARKLE image reading completed with expected headline results first half of May 2024
- Ascelia Pharma draws down SEK 15 million second tranche under existing loan facility
- Primary endpoint successfully met with strong headline results in Orviglance® phase 3 study
- Bulletin from the Annual General Meeting in Ascelia Pharma AB on 6 May 2024
- Ascelia Pharma hosts Investor Update: Bringing Orviglance to Patients
KEY EVENTS AFTER THE PERIOD
- Ascelia Pharma carries out a Rights Issue of units of approximately SEK 105 million to fully finance the NDA submission for Orviglance
- Notice of Extraordinary General Meeting in Ascelia Pharma 14 August
- Bulletin from the Extraordinary General Meeting in Ascelia Pharma 14 August
FINANCIAL SUMMARY Q2 (Apr-Jun) 2024
- Operating result of SEK -11.3M (SEK -41.8M)
- Earnings per share of SEK -0.39 (SEK -1.19)
- Cash flow from operations of SEK -12.0M (SEK -42.3M)
- Liquid assets and marketable securities of SEK 29.8M (SEK 70.5M)
"In May 2024, we announced strong positive headline results from our pivotal Phase 3 study, SPARKLE, with Orviglance. The results showed that Orviglance significantly improved the visualization of focal liver lesions, successfully meeting the primary endpoint with statistical significance for all three readers (<0.001).
The successful Phase 3 data reinforce our confidence in the regulatory and commercial path ahead for Orviglance and mark the completion of clinical development for Orviglance. We will now focus on bringing Orviglance through the regulatory submission and approval process with a submission of the New Drug Application (NDA) to the US Food and Drug Administration (FDA) expected by mid 2025. We also continue to advance the dialogue with potential commercialization partners to launch Orviglance and make it available to patients who need high-quality liver imaging without gadolinium-related safety risk.
On 10 July, we announced the launch of a rights issue of approximately SEK 105 million, secured to SEK 70 million. This financing improves our financial position and strengthens our ability to obtain an attractive agreement with commercialization partners. It also ensures that we can complete all activities for the NDA submission mid 2025 with high quality. I am pleased that the financing allows all our shareholders to take part in the significant value creation opportunities ahead.", said Magnus Corfitzen, CEO at Ascelia Pharma.
A presentation for analysts, investors and media will be held today 15 August 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:
Ascelia Pharma Q2 Report 2024 (financialhearings.com)
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.
Call Access (financialhearings.com)
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 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
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 successfully been completed with strong and consistent efficacy and safety results.
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.
This information is information that Ascelia Pharma is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-08-15 07:30 CEST.
