Panbela Therapeutics, Inc. (NASDAQ:PBLA) Q3 2023 Earnings Conference Call November 9, 2023 4:30 PM ET

Company Participants

James Carbonara - IR

Jennifer Simpson - CEO

Sue Horvath - CFO

Conference Call Participants

Jonathan Aschoff - ROTH MKM

Operator

Greetings, and welcome to the Panbela Therapeutics Third 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 may be 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. So let's start with our Phase 3 initiatives, specifically the ACQUIRE global clinical trial. ASPIRE is a global randomized, double-blind, placebo-controlled study designed to assess Ivospemin, or SPP-101, in conjunction with gemcitabine and nab-paclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma.

During Q3, we initiated enrollment in both the U.K. and Germany, successfully activating all intended countries for the ASPIRE trial, which are now actively enrolling patients. Additionally, in July, the independent Data Safety Monitoring Board, or DSMB, completed its scheduled safety review for treated patients in the trial and recommended the study's continuation without any changes. This achievement, alongside the full activation of all countries and DSMB's green light, provides substantial encouragement as we propel the trial forward. We anticipate interim data around mid-year 2024.