Panbela Therapeutics, Inc. (NASDAQ:PBLA) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET

Company Participants

James Carbonara - Investor Relations

Jennifer Simpson - Chief Executive Officer

Sue Horvath - Chief Financial Officer

Conference Call Participants

Jonathan Aschoff - ROTH MKM

Operator

Greetings and welcome to the Panbela Therapeutics Second Quarter 2023 Earnings Call. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to your host, James Carbonara, Investor Relations at Panbela. James, you may begin.

James Carbonara

Thank you, operator. With me on the call are Jennifer Simpson, Chief Executive Officer; and Sue Horvath, Chief Financial Officer.

Before I turn the call over to Dr. Simpson, please note that statements made on this call that are not historical facts maybe forward-looking statements. Significant risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward-looking statements are detailed in the company’s annual report on Form 10-K and supplemented by subsequently filed quarterly reports on Form 10-Q as well as in other reports that the company has filed with the SEC. Any forward-looking statements made on this call are made only as of today’s date, and the company does not undertake any obligation to update or supplement any such statements to reflect subsequent developments.

Now I would like to turn the call over to Jennifer Simpson, CEO of Panbela. Jennifer, please proceed.

Jennifer Simpson

Thank you, James, and thank you, everyone, for joining. I will begin the call with a review of our clinical development program, recent accomplishments and upcoming milestones, Sue will then follow with a review of the financial results, and then we will open it up for Q&A.

Starting with our Phase 3 program, I’d like to begin with our ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer. ASPIRE is a global randomized, double-blind, placebo-controlled clinical trial to evaluate ivospemin, or SBP-101, in combination with gemcitabine and nab-paclitaxel in patients with untreated metastatic pancreatic ductal adenocarcinoma.

Last month, we opened enrollment in the UK and Germany. We now have all planned countries in the ASPIRE trial opened and actively enrolling. Also in July, the Independent Data Safety Monitoring Board, or DSMB, for the ASPIRE trial completed its pre-specified review of safety data for treated patients in the trial. The DSMB has recommended that the study continue without modification. Having all countries opened and enrolling and DSMB approval to proceed is highly encouraging as we continue to advance the trial. Interim data is expected as soon as early 2024.