Ascelia Pharma AB (publ) (ticker: ACE) today published its Interim Report Q1 for 2024 (January - March), which is now available on the company's website though this link.
KEY EVENTS IN Q1 2024
- 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
KEY EVENTS AFTER THE PERIOD
- 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
- 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
FINANCIAL SUMMARY Q1 (Jan-Mar) 2024
- Operating result of SEK -16.7M (SEK -36.7M)
- Earnings per share of SEK -0.5 (SEK -1.1)
- Cash flow from operations of SEK -15.0M (SEK -37.5M)
- Liquid assets and marketable securities of SEK 26.5M (SEK 111.4M)
"On 2 May 2024, we announced positive headline results from our Phase 3 study with Orviglance. It was a day the entire team has been eagerly waiting for. The results were strong and showed that Orviglance significantly improved visualization of focal liver lesions, successfully meeting the primary endpoint in the pivotal Phase 3 study, SPARKLE with statistical significance for all three readers (<0.001). These strong results mark the completion of clinical development for Orviglance and reinforce our confidence in the regulatory and commercial path ahead for Orviglance.
We will now focus on bringing Orviglance through the regulatory submission and approval process. In parallel, we will continue to advance launch readiness and dialogue with potential commercialization partners to make Orviglance available to patients who need high-quality liver imaging without gadolinium related safety risk. Submission of the New Drug Application (NDA) to the US Food and Drug Administration (FDA) to obtain regulatory approval is expected by mid-2025.
We look very much forward to executing on the opportunities ahead for Ascelia Pharma in 2024 and beyond", said Magnus Corfitzen, CEO at Ascelia Pharma.
A presentation for analysts, investors and media will be held today 16 May 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 this link.
To participate via teleconference, please register through this link. After registration, you will be provided with phone numbers and a conference ID to access the conference.
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.
