Abeona Therapeutics Inc. (NASDAQ:ABEO) Q2 2024 Earnings Conference Call August 12, 2024 8:30 AM ET

Corporate Participants

Greg Gin - Vice President of Investor Relations & Corporate Communications
Vish Seshadri - President and Chief Executive Officer
Madhav Vasanthavada - Chief Commercial Officer and Head of Business Development
Joe Vazzano - Chief Financial Officer

Conference Call Participants

Farzin Haque - Jefferies
Dae Gon Ha - Stifel
Ram Selvaraju - H.C. Wainwright
Rick Miller - Cantor Fitzgerald
James Molloy - Alliance Global Partners

Operator

Good morning, everyone, and welcome to the Abeona Therapeutics Second Quarter 2024 Conference Call. At this time, all participants are in a listen-only mode, and we will open for questions following the presentation. [Operator Instructions] Please note, this conference is being recorded.

I will now turn the conference over to your host, Greg Gin, Vice President of Investor Relations and Corporate Communications. Greg, the floor is yours.

Greg Gin

Thank you, Jenny. Good morning and thank you for joining us on our second quarter 2024 conference call. During this call, we will refer to the press release issued this morning announcing the second quarter results, which is available on our corporate website at www.abeonatherapeutics.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 results may differ materially from those expressed or implied in the forward-looking statements.

Various factors that could cause actual results to differ include, but are not limited to, those identified under the Risk Factors section in our Form 10-K and periodic reports filed with the SEC. These documents are available on our website at www.abeonatherapeutics.com.

On the call today with prepared remarks are Dr. Vish Seshadri, Chief Executive Officer; Dr. Madhav Vasanthavada, Chief Commercial Officer and Head of Business Development; and Joe Vazzano, Chief Financial Officer. Also joining us for the Q&A session will be Dr. Brian Kevany, Chief Technical Officer.

And with that, I will now turn the call over to Vish Seshadri to lead us off. Vish?

Vish Seshadri

Thank you, Greg. Good morning, everyone. We appreciate everybody joining this call. We're excited to provide our second quarter update, and I'll start with the status of the BLA resubmission process. As a reminder, this complete response letter highlighted the need for additional CMC information pertaining to in general validation requirements for certain manufacturing and release testing methods. The CRO that we received in April did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA and the FDA did not request any new clinical trials or clinical data to support the approval of pz-cel.