Q3 2024 Abeona Therapeutics Inc Earnings Call Transcript
Key Points
- Abeona Therapeutics Inc (ABEO) successfully resubmitted their Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) to the FDA, which was accepted for review with a PDUFA date set for April 29, 2025.
- The FDA did not request any new clinical trials or data for the approval of pz-cel, indicating confidence in the existing clinical efficacy and safety data.
- Abeona Therapeutics Inc (ABEO) has secured new patents for pz-cel, extending intellectual property protection until 2040, which underscores the innovative nature of their technology.
- The company has made significant progress in commercial launch preparations, including building a strong commercialization team and engaging with key treatment centers across the US.
- Abeona Therapeutics Inc (ABEO) has a solid financial position with $110 million in cash and equivalents, providing sufficient resources to fund operations into 2026.
- The company received a Complete Response Letter (CRL) from the FDA in April, highlighting the need for additional CMC data, which delayed the approval process.
- There is a potential supply constraint at launch, as the current manufacturing capacity may not meet the anticipated demand for pz-cel.
- The company faces competition from existing treatments like Vyjuvek and Filsuvez, which could impact market penetration and adoption of pz-cel.
- Abeona Therapeutics Inc (ABEO) reported a net loss of $30.3 million for the third quarter of 2024, partly due to a $15.2 million loss from the remeasurement of warrant and derivative liabilities.
- The expansion of manufacturing capacity involves regulatory reviews and could take 18 to 24 months, potentially limiting the ability to scale up production quickly.
Good morning, and welcome to the Abeona Therapeutics third quarter 2024 conference call. (Operator Instructions) Please note, this conference is being recorded.
I will now turn the conference over to your host, Greg Gin, VP of Investor Relations. Greg, the floor is yours.
Thank you, Jenny. Good morning, everyone, and thank you for joining us on our third-quarter 2024 conference call.
During this call, we'll refer to the press release issued this morning announcing the third quarter results, which is available on our corporate website at www.abeonathapeutics.com. I would like to note that remarks made during today's call may contain projections and forward-looking statements.
Forward-looking statements are made pursuant to the safe harbor provisions of the federal securities laws. These forward-looking statements are based on current expectations and are subject to change, and actual
| Access to All Earning Calls and Stock Analysis | |
| 30-Year Financial on one screen | |
| All-in-one Stock Screener with unlimited filters | |
| Customizable Stock Dashboard | |
| Real Time Insider Trading Transactions | |
| 8,000+ Institutional investors’ 13F holdings | |
| Powerful Excel Add-in and Google sheets Add-on | |
| All data downloadable | |
| Quick customer support | |
| And much more... |
Trustpilot
We'd love to learn more about your experiences on GuruFocus.com and how we can improve!
Take Survey
