Panbela Therapeutics, Inc.

Good afternoon, everyone, and welcome to the Panbella Therapeutics first quarter 2024 earnings call. At this time, all participants have been placed on a listen-only mode, and we will open for questions following the presentation. If anyone should require operator assistance during this conference, please press star zero on your phone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, James Carbonara, Investor Relations. James, over to you.

Thank you, Operator. Joining me on today's call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath, Chief Financial Officer. Before we begin, please note that statements made during this call that are not historical facts may be considered forward-looking statements. Risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements are detailed in the company's filings with the SEC. Any forward-looking statements made on this call speak only as of today's date, and the company does not undertake any obligation to update or revise any of these statements to reflect future events or circumstances. With that, I will turn the call over to Dr. Simpson. Jennifer, please go ahead.

Thank you, James, and thank you all for joining us. I will start by discussing our clinical development programs, recent achievements, and upcoming milestones. Then Sue will review our financial results before we open up the call for Q&A. Let us begin with our phase three ASPIRE global clinical trial. ASPIRE is evaluating ibuprofen or SPP-101 in combination with gemcitabine and nabpaclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma. We were excited to announce in January that the ASPIRE enrollment had surpassed 50%, proceeding faster than initially anticipated. With all sites now open and actively enrolling, we expect full enrollment of approximately 600 patients to be completed by the first quarter of 2025. With respect to interim data, the ASPIRE trial requires 33% of the total expected events to occur before the interim analysis can be conducted. As of the latest assessment, less than half of the required events for the interim analysis had occurred. While we initially anticipated the interim analysis to take place in mid-2024, we are encouraged by the lower than expected event rate, which suggests that patients in the ASPIRE trial have experienced prolonged survival. We are now projecting the interim analysis to occur as early as first quarter 2025. This is a positive development for patients and underscores the potential of ibospemin in addressing a significant unmet need in the treatment of metastatic pancreatic ductal adenocarcinoma. We also want to reiterate the significance of the ASPIRE trial in the context of recent advancements in metastatic pancreatic fetal adenocarcinoma treatment, such as the NAPLI-3 trials, which led to the approval of liposomal arenatechin, or Onivide, in combination with Floracil, Oxaliplatin, and Leucovorn, known as the Naller-Fox regimen. Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nabpaclitaxel, the prognosis for patients with metastatic pancreatic ductal endocarcinoma remains poor with median overall survival still less than 12 months. The incremental benefits and median survival have been modest in the past 11 years with the recent approval of Onivide in the Niller-Flax regimen demonstrating the 1.9-month survival benefit compared to the approval of gemcitabine and nabpaclitaxel, which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. We believe that the addition of ibuprofen or SVP-101 to the standard of care regimen of gemcitabine and nabpaclitaxel has the potential to significantly improve outcomes for patients with metastatic pancreatic ductal adenocarcinoma beyond the incremental benefits observed with the recently approved therapy. The early indications from the ASPIRE trial support this belief, and we remain committed to advancing this important study and look forward to sharing the interim results in the first quarter of 2025. Turning to our familial adenomatous polyposis, or FAP program, we remain committed to collaborating with the FDA, EMA, and the FAP community to advance this initiative. Once we obtain consensus on a global registration plan, we intend to move this program forward while exploring ways to maximize its value. In our PACES trial, a phase three study of plenpovy for the prevention of high-risk adenomas and second primary colorectal cancers, enrollment is complete and we anticipate data by the second half of 2026. This study, funded by the NCI and conducted by the Southwest Oncology Group, known as SWOG, successfully passed a planned futility analysis. Moving on to our phase two studies, In September, we entered into an agreement with U.S. Rural Meds to divest assets from the aflornithine pediatric neuroblastoma program. PAMBELLA has received an upfront payment of $400,000 with an additional $775,000 received in lieu of U.S. sales milestones in the latter years. PAMBELLA stands to receive additional payments as U.S. Rural Meds achieves key milestones. As a reminder, in December, U.S. World Meds received FDA approval of its NDA for flornithine, marking the first FDA approval of a polyamine-targeted therapy in a cancer indication. This approval not only benefits Pambella financially, but also helps to validate the role polyamines can play in cancer therapy as we advance our other programs. We also entered into a clinical trial agreement for a Phase II trial of a flornithine, in castration-resistant metastatic prostate cancer. This study is actively enrolling. The phase two of thornithine trial in type 1 diabetes is a multi-center, double-blind, placebo-controlled, two-to-one random assigned clinical trial led by Indiana University School of Medicine and supported by JDRF. All six centers are open and enrolling patients with an anticipated interim analysis next year. We are also planning a phase two study, evaluating ibisbemin in the platinum resistant ovarian cancer, which we hope to begin in the second half of this year in collaboration with Johns Hopkins University School of Medicine. In fact, last month at the American Association for Cancer Research or AACR's annual meeting, we presented a poster highlighting the efficacy of ibisbemin as a polyamine metabolism modulator in ovarian cancer. Ivosfemin reduces the viability of human ovarian adenocarcinoma cell lines, regardless of their platinum sensitivity, and we found that the combination treatment with doxorubicin increases median survival, delays tumor onset, and decreases overall tumor burden compared to either clinical or subclinical doxorubicin dosing schemes. The results suggest that SVP-101 in combination with doxorubicin, may have a role in the clinical management of ovarian cancer. In particular, it's difficult to treat platinum-resistant populations where few options exist. These studies continue to support the basis for moving into a clinical trial program in ovarian cancer with a goal of developing effective, novel therapeutics in combination with standard of care for patients with unmet medical needs. The poster provided Additional details on the preclinical studies. Treatment with doxorubicin significantly increased the in vitro toxicity of SVP101 in both cisplatin sensitive and cisplatin resistant ovarian cancer cell lines. SVP101 and doxorubicin cooperatively increased polyamine catabolism and decreased overall cell survival in vitro. In an immunocompetent mouse model of ovarian cancer, the combination of SPT-101 and doxorucin significantly increased median survival time, delayed ascites formation, and decreased overall tumor burden. Interestingly, this survival benefit was not inserved in the immunodeficient mice, indicating that an intact immune system is required for the efficacy of this therapy. These promising preclinical results provide a strong foundation as we prepare to initiate our ovarian cancer clinical program later this year. Future studies will evaluate IVO7 in combination with other polyamine metabolism modulators, as well as immune modulators. In Phase I development, we have two programs. Our Phase I-II collaboration with Moffitt Cancer Center is open and screening. We anticipate enrolling our first patient in the first half of this year and initiating the Phase II trial in the first half of 2025. Finally, we are looking to initiate the Graphic Investigator Initiative in the second half of this year. In the preclinical setting, we are also engaged in an ongoing research initiative with MD Anderson Cancer Center, focusing on evaluating polyamide metabolic inhibitor therapies with CAR-T cell therapies and bispecific monoclonal antibodies in preclinical models. We recently announced the acceptance of an abstract detailing research on SPP101 and and FloraLoma cell lines for online publication at the ASH meeting. On the IP front, we recently announced the issuance of a new patent in the U.S. and Canada. This patent is for claims of a fixed-dose combination of a FloraLoma and Sulandoc. In summary, our projected first half 2024 milestones include enrolling our first patients in the non-small cell lung cancer phase 1 trial, announcing gastric cancer prevention phase 2 results, In the second half of this year, we anticipate opening the neoadjuvant pancreatic cancer trial, opening the Phase II ovarian trial, publishing the final Phase I-Ib metastatic pancreatic trial data, and obtaining FDA and EMA feedback for a global registration trial in FAP. And in 2025, early on, we anticipate overall survival interim analysis for our Phase III Aspire trial in the first quarter, and the opening of the non-small cell lung cancer phase two trial in the first half of the year. The first quarter and year to date have marked significant clinical development strides for PAMBELLA. We look forward to continued progress and value creation in 2024. I will now turn the call over to Sue to discuss our financial results. Sue?