Panbela Therapeutics, Inc.

Good day, ladies and gentlemen, and welcome to the PanBella fourth quarter 2021 earnings call. At this time, all participants are in a listen-only mode, and the floor will be open for your questions and comments following the presentation. It is now my pleasure to turn the floor over to your host, James Carbonara. Sir, the floor is yours.

Thank you. And once again, welcome to PanBella's fourth quarter 2021 earnings call. 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 obligations 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 Panvela. Jennifer, please proceed.

Thank you, everyone, for joining. I will begin the call by touching on 2021 and recent significant accomplishments. Sue will then follow with a review of the financial results and then we will open it up for Q&A. So starting with 2021 and recent highlights. As many of you know, most recently, we entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals Incorporated, or CPP for short. The agreement consideration is a combination of stock and future contingent milestone payments that Sue will review in greater detail. CPP is currently a private clinical stage company developing therapeutics to reduce the risk and recurrence of cancer and rare diseases. Initial areas of focus include familial adenomatous polyposis, or FAP, and colorectal cancer prevention. The current lead asset for CPP is Slimpovy, which is a combination of CPP-1X, or aflurathine, and Sulindax, and it has a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. As a result of a 2021 North American license agreement, CPP's FAP registration trial is fully funded and is scheduled to begin by year end. In addition, a phase three trial in colon cancer survivors is currently underway and is sponsored by the Southwest Oncology Group, or SWOG. Several other clinical trials in neuroblastoma, gastric cancer, and early onset type 1 diabetes are underway in collaboration with various cooperative groups. The combined company will have a much larger pipeline targeting approximately a $5 billion aggregate market opportunity for the areas of initial focus. Those include FAP, first line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention, and ovarian cancer. With the combined development programs, we will be poised to have a consistent stream of catalysts and use events with programs ranging from preclinical to registration studies under the guidance of a veteran management team with a demonstrated track record of drug discovery, development, and commercialization expertise. Moreover, acquiring CPP significantly advances our mission of treating diseases where there is an unmet need through a diversified pipeline addressing numerous targets and thus expanding the potential of the joint company. The combined platforms will be better positioned to treat more patients. The transaction is a strategic fit and we feel drives shareholder value. About a month prior to announcing CPP, so at the end of January here in 2022, we announced the initiation of our global randomized trial. This trial is a randomized, double-blind, placebo-controlled trial for SBP101 in combination with gemcitabine and nabpaclitaxel versus gemcitabine, nabpaclitaxel, and placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma and is referred to as the ASPIRE trial. The primary endpoint is overall survival with a futility analysis evaluating progression-free survival or PFS at 104 events. If the futility analysis is passed, the trial expands to allow for additional subjects so that the full trial could serve for registration. We are seeking to conduct a trial at leading cancer centers in the United States, Europe, and the Asia Pacific region. This Phase 2-3 trial is designed as a Phase 3 trial but with an interim Phase 2 look to assess whether the experimental treatment is active enough to continue the trial to its Phase 3 sample size. We believe the primary advantage of a Phase 2-3 trial over a separate Phase 2 and Phase 3 trial is speed and resource mitigation and that the Phase 2 patients can be included in the Phase 3 analysis and one does not have to wait for the Phase 3 protocol development after the Phase 2 results become available. Summit Cancer Centers in Spokane, Washington was the first clinical site activated with Dr. Arvind Chowdhury serving as its principal investigator. Approximately 60 to 70 additional sites are expected to be activated in 2022. We have commenced screening for eligible patients with enrollment expected to complete in approximately 12 months after the first patient enrolled. Supporting the advancement into the Phase 2-3 ASPIRE trial was data announced from our Phase 1b study at the ASCO Annual Meeting in 2021 and more recently in January of 2022 at the ASCO GI Meeting. Interim data from cohort four in the expansion showed an objective response rate of 48% and a median overall survival of 12 months, which at the time of the poster presentation was not yet final. Both exceeded historical rates reported for gemcitabine and nabpaclitaxel and supports the continued development of SPP101 as an addition to first-line treatment for metastatic pancreatic cancer and also for neoadjuvant treatment for patients with potentially resectable disease. Since the poster presentation, the median overall survival has been reached at 12.53 months. This is four months longer than what is typically seen with gemcitabine and nabpaclitaxel. While this data is from a phase one trial, this increase in objective response rate and median overall survival is encouraging. Lastly, we also have had patients who have demonstrated long-term survival with two patients from cohort two, one of which achieved 30.3 months and final, and 33 months and still alive. There are seven patients, one from cohort two and six from cohort four in the expansion, that are still in survival follow-up. We are excited to continue development of SBP101 in our global randomized phase 2-3 study in metastatic pancreatic cancer, which I spoke about earlier. In addition to SBP101's promise in pancreatic cancer, we believe it could be a treatment option for other cancers as well. Thus, early in 2021, we announced a research agreement with the Johns Hopkins University School of Medicine. The collaboration's intended focus was on the further development of PAMBELLA's investigative agent, SBP101, including activity in cell lines outside of pancreatic cancer, evaluating possible biomarkers which can form diagnostics, and potential combination with checkpoint inhibitors. In December, we were pleased to announce positive preclinical data supporting the activity of SBP101 in ovarian cancer cell lines. We expect to launch a development effort for SBP101 in ovarian cancer in the first half of this year. The preclinical results illustrate SBP101's potential to expand into another area of high unmet need. According to the American Cancer Society, ovarian cancer was the fifth leading cause of cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. In fact, the European Society for Medical Oncology, or ESMO, has stated that ovarian cancer represents a significant unmet need in gynecologic cancers with the absence of a well-defined screening program or programs and inconsistent initial symptoms leading to late diagnosis in most patients. Considered largely incurable, ovarian cancer typically relapses within three years in 80% of women, with subsequent recurrence arising sooner each time as resistance to chemotherapy develops. Therefore, it is vital to progress potential new therapies such as SBP101 for ovarian cancer. We recently issued a press release that an abstract for SBP101 had been accepted for poster presentation at the American Association for Cancer Research, or AACR, which will be held April 8th through the 13th of this year. The work reflects the company's ongoing collaboration with Johns Hopkins University School of Medicine. Before the end of 2021, we also completed the preclinical work necessary to begin a neoadjuvant trial. We are working with key opinion leaders to finalize the protocol and obtain the necessary institutional approvals to open this investigator-initiated trial in the second half of this year. Turning to intellectual property in 2021, we announced that we received an issue notification for covering a shorter synthesis of SBP 101 that provides many benefits, including the ability to manufacture product with a reduced lead time, quicker access to drug supply, which facilitates expansion into additional indications, and a potentially scalable, efficient, and cost-effective manufacturing process to implement as soon as we are ready to commercialize upon approval. Also, in terms of the balance sheet, recall that in Q3, of 2021, we closed on a $10 million underwritten bought deal offering of our common stock. That capital has provided important resources to keep us on the path of further developing and expanding the application of SBP 101 and drive shareholder value. Another 2021 highlight for us includes joining the Russell Microcap Index. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. At this point, I would like to finish by reiterating our milestones. In the first half of this year, we expect to announce the first patient enrolled in our ASPIRE trial, as well as expansion outside the U.S., satisfaction of conditions and closing of the CPP acquisition, research call to review the ovarian cancer data and ovarian cancer treatment standards, The final data from our phase one first line metastatic pancreatic cancer study, initiation of the ovarian cancer program for SPP 101, and in the second half of this year, we expect to open the neoadjuvant pancreatic cancer investigator-initiated trial. With the expected closing of the CPP transaction, we anticipate that additional milestones for 2022 will increase the flow of planned development activity and data. In summary, we have made tremendous progress in 2021 and year to date. We are excited to shareholder value in 2022 by executing against our stated milestones. I will stop here and turn it over to Sue to review the financials.